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Clinical Trial Results:
A Phase 3 Multicenter, Double-Blind Study to Evaluate the Long-Term Safety and Efficacy of Baricitinib in Adult Patients with Atopic Dermatitis

Summary
EudraCT number	2017-000873-35
Trial protocol	DE CZ HU AT ES PL FR DK IT
Global end of trial date

Results information
Results version number	v1(current)
This version publication date	02 Jun 2022
First version publication date	02 Jun 2022
Other versions

Trial Information
Subject Disposition
Baseline Characteristics
End Points
Adverse Events
More Information

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Trial information

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Sponsor protocol code

I4V-MC-JAHN

ISRCTN number

US NCT number

NCT03334435

WHO universal trial number (UTN)

Other trial identifiers

Trial Number: 16587

Sponsor organisation name

Eli Lilly and Company

Sponsor organisation address

Lilly Corporate Center, Indianapolis, IN, United States, 46285

Public contact

Available Mon ‐ Fri 9 AM ‐ 5 PM EST, Eli Lilly and Company, 1 877‐CTLilly,

Scientific contact

Available Mon ‐ Fri 9 AM ‐ 5 PM EST, Eli Lilly and Company, 1 877‐285‐4559,

Is trial part of an agreed paediatric investigation plan (PIP)

Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial?

Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial?

Analysis stage

Interim

Date of interim/final analysis

21 Sep 2020

Is this the analysis of the primary completion data?

Yes

Primary completion date

21 Sep 2020

Global end of trial reached?

Main objective of the trial

The purpose of this study is to evaluate the long-term safety and efficacy of baricitinib in participants with atopic dermatitis. Participants were enrolled in this study from the originating studies (JAHL, JAHM, JAIY) or were directly enrolled in the open-label arm.

Protection of trial subjects

This study was conducted in accordance with International Conference on Harmonization (ICH) Good Clinical Practice, and the principles of the Declaration of Helsinki, in addition to following the laws and regulations of the country or countries in which a study is conducted.

Background therapy

Background topical corticosteroids were permitted for use at the discretion of the investigator.

Evidence for comparator

Actual start date of recruitment

28 Mar 2018

Long term follow-up planned

Independent data monitoring committee (IDMC) involvement?

Yes

Number of subjects enrolled per country

Country: Number of subjects enrolled

Argentina: 114

Country: Number of subjects enrolled

Australia: 109

Country: Number of subjects enrolled

Austria: 49

Country: Number of subjects enrolled

Czechia: 102

Country: Number of subjects enrolled

Denmark: 7

Country: Number of subjects enrolled

France: 34

Country: Number of subjects enrolled

Germany: 196

Country: Number of subjects enrolled

Hungary: 72

Country: Number of subjects enrolled

India: 31

Country: Number of subjects enrolled

Israel: 34

Country: Number of subjects enrolled

Italy: 68

Country: Number of subjects enrolled

Japan: 244

Country: Number of subjects enrolled

Korea, Democratic People's Republic of: 107

Country: Number of subjects enrolled

Mexico: 107

Country: Number of subjects enrolled

Poland: 132

Country: Number of subjects enrolled

Russian Federation: 51

Country: Number of subjects enrolled

Spain: 80

Country: Number of subjects enrolled

Switzerland: 18

Country: Number of subjects enrolled

Taiwan: 90

Worldwide total number of subjects

1645

EEA total number of subjects

740

Number of subjects enrolled per age group

In utero

Preterm newborn - gestational age < 37 wk

Newborns (0-27 days)

Infants and toddlers (28 days-23 months)

Children (2-11 years)

Adolescents (12-17 years)

Adults (18-64 years)

1602

From 65 to 84 years

85 years and over

Subject disposition

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Recruitment details

Participants who entered Study JAHN were classified as “Responders and Partial Responders (RPR): Investigator's Global Assessment (IGA) of (0,1, or 2) at entry to study JAHN and never rescued in originating study” or “Non-responders: those not meeting definition of RPR".

Screening details

Participants who entered JAHN previously participated in JAHL, JAHM and JAIY and met the criteria for those studies, and, in the opinion of the investigator, there was unacceptable risk for the participants continued participation in the study. OR Participants who directly entered JAHN and met the criteria of JAHL, JAHM and JAIY.

Period 1 title

Overall Study (overall period)

Is this the baseline period?

Yes

Allocation method

Randomised - controlled

Blinding used

Double blind

Roles blinded

Subject, Investigator

Are arms mutually exclusive

Yes

Placebo

Arm description

Participants from previous Baricitinib monotherapy studies (JAHL, JAHM) and combination therapy study (JAIY) were randomized or assigned to this arm to receive placebo orally.

Arm type

Placebo

Investigational medicinal product name

Placebo

Investigational medicinal product code

Other name

Pharmaceutical forms

Tablet

Routes of administration

Oral use

Dosage and administration details

Administered orally

Bari 1- milligram (mg)

Arm description

Participants from previous Baricitinib monotherapy studies (JAHL, JAHM) were randomized or assigned to this arm to receive Baricitinib 1 mg orally.

Arm type

Experimental

Investigational medicinal product name

Baricitinib

Investigational medicinal product code

Other name

LY3009104

Pharmaceutical forms

Tablet

Routes of administration

Oral use

Dosage and administration details

Administered orally

Bari 2-mg

Arm description

Participants from previous Baricitinib monotherapy studies (JAHL, JAHM) and combination study (JAIY) were randomized or assigned to this arm to receive Baricitinib 2 mg orally.

Arm type

Experimental

Investigational medicinal product name

Baricitinib

Investigational medicinal product code

Other name

LY3009104

Pharmaceutical forms

Tablet

Routes of administration

Oral use

Dosage and administration details

Administered orally

Bari 4-mg

Arm description

Participants from previous Baricitinib monotherapy studies (JAHL, JAHM) and combination study (JAIY) were randomized or assigned to this arm to receive Baricitinib 4 mg orally.

Arm type

Experimental

Investigational medicinal product name

Baricitinib

Investigational medicinal product code

Other name

LY3009104

Pharmaceutical forms

Tablet

Routes of administration

Oral use

Dosage and administration details

Administered orally

Bari 2-mg Open-Label Addendum

Arm description

Participants were directly enrolled to this open-label arm to receive Baricitinib 2-mg orally.

Arm type

Experimental

Investigational medicinal product name

Baricitinib

Investigational medicinal product code

Other name

LY3009104

Pharmaceutical forms

Tablet

Routes of administration

Oral use

Dosage and administration details

Administered orally

Number of subjects in period 1	Placebo	Bari 1- milligram (mg)	Bari 2-mg	Bari 4-mg	Bari 2-mg Open-Label Addendum
Started	91	45	519	743	247
Completed	2	2	12	15	5
Not completed	89	43	507	728	242
Consent withdrawn by subject	11	4	38	42	20
Adverse event, non-fatal	2	1	9	23	13
Death	-	-	-	1	-
Not specified	-	1	3	2	1
Ongoing as of Week 52	70	32	379	519	146
Lost to follow-up	3	-	2	1	1
Lack of efficacy	3	5	76	140	61

Baseline characteristics

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Reporting group title

Placebo

Reporting group description

Participants from previous Baricitinib monotherapy studies (JAHL, JAHM) and combination therapy study (JAIY) were randomized or assigned to this arm to receive placebo orally.

Reporting group title

Bari 1- milligram (mg)

Reporting group description

Participants from previous Baricitinib monotherapy studies (JAHL, JAHM) were randomized or assigned to this arm to receive Baricitinib 1 mg orally.

Reporting group title

Bari 2-mg

Reporting group description

Participants from previous Baricitinib monotherapy studies (JAHL, JAHM) and combination study (JAIY) were randomized or assigned to this arm to receive Baricitinib 2 mg orally.

Reporting group title

Bari 4-mg

Reporting group description

Participants from previous Baricitinib monotherapy studies (JAHL, JAHM) and combination study (JAIY) were randomized or assigned to this arm to receive Baricitinib 4 mg orally.

Reporting group title

Bari 2-mg Open-Label Addendum

Reporting group description

Participants were directly enrolled to this open-label arm to receive Baricitinib 2-mg orally.

Reporting group values	Placebo	Bari 1- milligram (mg)	Bari 2-mg	Bari 4-mg	Bari 2-mg Open-Label Addendum	Total
Number of subjects	91	45	519	743	247	1645
Age categorical
Units: Subjects
In utero						0
Preterm newborn infants (gestational age < 37 wks)						0
Newborns (0-27 days)						0
Infants and toddlers (28 days-23 months)						0
Children (2-11 years)						0
Adolescents (12-17 years)						0
Adults (18-64 years)						0
From 65-84 years						0
85 years and over						0
Age continuous
Units: years
arithmetic mean (standard deviation)	35.2 ± 14.06	33.5 ± 8.49	34.2 ± 12.69	35.6 ± 12.85	34.9 ± 12.98	-
Gender categorical
Units: Subjects
Female	44	16	206	239	112	617
Male	47	29	313	504	135	1028
Race (NIH/OMB)
Units: Subjects
American Indian or Alaska Native	6	4	10	6	16	42
Asian	32	7	174	282	13	508
Native Hawaiian or Other Pacific Islander	0	0	1	0	0	1
Black or African American	0	0	1	1	1	3
White	48	32	315	429	211	1035
More than one race	5	2	18	23	6	54
Unknown or Not Reported	0	0	0	2	0	2
Region of Enrollment
Units: Subjects
Argentina	6	2	36	46	24	114
Hungary	7	2	15	21	27	72
Czechia	3	3	22	46	28	102
Japan	11	3	89	141	0	244
Switzerland	0	1	5	9	3	18
India	5	0	7	19	0	31
Spain	2	1	27	26	24	80
Russia	0	1	9	13	28	51
Austria	2	0	12	23	12	49
South Korea	9	1	39	58	0	107
Taiwan	8	2	30	50	0	90
Denmark	0	0	0	0	7	7
Poland	10	7	45	70	0	132
Italy	7	4	16	26	15	68
Mexico	9	5	29	21	43	107
Israel	1	0	16	13	4	34
France	0	0	15	19	0	34
Australia	4	1	30	42	32	109
Germany	7	12	77	100	0	196

End points

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Reporting group title

Placebo

Reporting group description

Participants from previous Baricitinib monotherapy studies (JAHL, JAHM) and combination therapy study (JAIY) were randomized or assigned to this arm to receive placebo orally.

Reporting group title

Bari 1- milligram (mg)

Reporting group description

Participants from previous Baricitinib monotherapy studies (JAHL, JAHM) were randomized or assigned to this arm to receive Baricitinib 1 mg orally.

Reporting group title

Bari 2-mg

Reporting group description

Participants from previous Baricitinib monotherapy studies (JAHL, JAHM) and combination study (JAIY) were randomized or assigned to this arm to receive Baricitinib 2 mg orally.

Reporting group title

Bari 4-mg

Reporting group description

Participants from previous Baricitinib monotherapy studies (JAHL, JAHM) and combination study (JAIY) were randomized or assigned to this arm to receive Baricitinib 4 mg orally.

Reporting group title

Bari 2-mg Open-Label Addendum

Reporting group description

Participants were directly enrolled to this open-label arm to receive Baricitinib 2-mg orally.

Subject analysis set title

RPR-Placebo

Subject analysis set type

Per protocol

Subject analysis set description

Responders or partial responders (RPR) [Investigator's Global Assessment (IGA) of (0,1, or 2) at entry to study JAHN and never rescued in originating study] participants from previous Baricitinib monotherapy studies-JAHL and JAHM and combination therapy study-JAIY were assigned to remain in this arm to receive placebo orally.

Subject analysis set title

RPR-Bari 1-mg

Subject analysis set type

Per protocol

Subject analysis set description

RPR participants from previous Baricitinib monotherapy studies-JAHL and JAHM were assigned to remain in this arm to receive Baricitinib 1 mg orally.

Subject analysis set title

RPR-Bari 2-mg

Subject analysis set type

Per protocol

Subject analysis set description

RPR participants from previous Baricitinib monotherapy studies-JAHL and JAHM and combination therapy study-JAIY were assigned to remain in this arm to receive Baricitinib 2 mg orally.

Subject analysis set title

RPR-Bari 4-mg

Subject analysis set type

Per protocol

Subject analysis set description

RPR participants from previous Baricitinib monotherapy studies-JAHL and JAHM and combination therapy study-JAIY were assigned to remain in this arm to receive Baricitinib 4 mg orally.

Subject analysis set title

Placebo

Subject analysis set type

Per protocol

Subject analysis set description

Participants from previous Baricitinib monotherapy studies (JAHL, JAHM) and combination therapy study (JAIY) were randomized or assigned to this arm to receive placebo orally.

Subject analysis set title

Bari 2 mg

Subject analysis set type

Per protocol

Subject analysis set description

Participants from previous Baricitinib monotherapy studies (JAHL, JAHM) and combination therapy study (JAIY) were randomized or assigned to this arm to receive Baricitinib 2 mg orally.

Subject analysis set title

Bari 4 mg

Subject analysis set type

Per protocol

Subject analysis set description

Participants from previous Baricitinib monotherapy studies (JAHL, JAHM) and combination therapy study (JAIY) were randomized or assigned to this arm to receive Baricitinib 4 mg orally.ly.

Subject analysis set title

NR: Bari 1 mg to 2 mg

Subject analysis set type

Per protocol

Subject analysis set description

Non-responder (NR) [those not meeting definition of RPR] participants from previous Baricitinib monotherapy studies-JAHL and JAHM who received Baricitinib 1 mg and were re-randomized to this arm to receive Baricitinib 2 mg orally.

Subject analysis set title

NR: Bari 1 mg to 4 mg

Subject analysis set type

Per protocol

Subject analysis set description

NR participants from previous Baricitinib monotherapy studies-JAHL and JAHM who received Baricitinib 1 mg and were re-randomized to this arm to receive Baricitinib 4 mg orally.

Subject analysis set title

NR: Bari 2 mg to 2 mg

Subject analysis set type

Per protocol

Subject analysis set description

NR participants from previous Baricitinib monotherapy studies-JAHL and JAHM and combination therapy study-JAIY who received Baricitinib 2 mg and were re-randomized to this arm to receive Baricitinib 2 mg orally.

Subject analysis set title

NR: Bari 2 mg to 4 mg

Subject analysis set type

Per protocol

Subject analysis set description

Subject analysis set title

NR: Bari 4 mg to 4 mg

Subject analysis set type

Per protocol

Subject analysis set description

NR participants from previous Baricitinib monotherapy studies-JAHL and JAHM and combination therapy study-JAIY who received Baricitinib 4 mg and were re-randomized to this arm to receive Baricitinib 4 mg orally.

Subject analysis set title

NR: Placebo to Bari 2 mg

Subject analysis set type

Per protocol

Subject analysis set description

NR participants from previous Baricitinib monotherapy studies-JAHL and JAHM and combination therapy study-JAIY who received placebo and were re-randomized to this arm to receive Baricitinib 2 mg orally.

Subject analysis set title

NR: Placebo to Bari 4 mg

Subject analysis set type

Per protocol

Subject analysis set description

Subject analysis set title

Bari 2-mg Open-Label Addendum

Subject analysis set type

Per protocol

Subject analysis set description

Participants were directly enrolled to this open-label arm to receive Baricitinib 2-mg orally.

Subject analysis set title

Bari 1 mg

Subject analysis set type

Per protocol

Subject analysis set description

Participants from previous Baricitinib monotherapy studies (JAHL, JAHM) were randomized or assigned to this arm to receive Baricitinib 1 mg orally.

Primary: Responder and Partial Responders (RPR): Number of Participants From Monotherapy Studies (JAHL, JAHM) Who Achieved a Response of Investigator's Global Assessment (IGA) 0 or 1

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End point title

Responder and Partial Responders (RPR): Number of Participants From Monotherapy Studies (JAHL, JAHM) Who Achieved a Response of Investigator's Global Assessment (IGA) 0 or 1 ^[1]

End point description

The IGA measures the investigator's global assessment of the participant's overall severity of their atopic dermatitis (AD), based on a static, numeric 5-point scale from 0 (clear skin) to 4 (severe disease). The score is based on an overall assessment of the degree of erythema, papulation/induration, oozing/crusting, and lichenification. The results were analyzed using non-responder imputation (NRI). All participants who either discontinued the study treatment or discontinued the study for any reason at any time were defined as non-responders for the NRI analysis for categorical variables such as IGA 0/1. Modified Intent-to-treat Population: All RPR participants who received at least one dose of IP in JAHN. The participants here are from the previous Baricitinib monotherapy studies (JAHL and JAHM) as the results are presented as subsets of overall RPR population.

End point type

Primary

End point timeframe

Weeks 16, 36 and 52

Notes
[1] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
Justification: The results were analyzed using non-responder imputation (NRI).

End point values	RPR-Placebo	RPR-Bari 1-mg	RPR-Bari 2-mg	RPR-Bari 4-mg
Number of subjects analysed	52	45	54	70
Units: participants
number (not applicable)
Week 16	19	21	32	34
Week 36	12	14	34	26
Week 52	15	16	27	28

No statistical analyses for this end point

Primary: RPR: Number of Participants From Combination Therapy Study (JAIY) Who Achieved a Response of IGA 0 or 1

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End point title

RPR: Number of Participants From Combination Therapy Study (JAIY) Who Achieved a Response of IGA 0 or 1 ^[2]

End point description

The IGA measures the investigator's global assessment of the participant's overall severity of their atopic dermatitis (AD), based on a static, numeric 5-point scale from 0 (clear skin) to 4 (severe disease). The score is based on an overall assessment of the degree of erythema, papulation/induration, oozing/crusting, and lichenification. The results were analyzed using NRI. All participants who either discontinued the study treatment or discontinued the study for any reason at any time were defined as non-responders for the NRI analysis for categorical variables such as IGA 0/1. Modified Intent-to-treat Population: All RPR participants who received at least one dose of IP in JAHN. The participants here are from the previous Baricitinib combination therapy study (JAIY) as the results are presented as subsets of overall RPR population.

End point type

Primary

End point timeframe

Weeks 16, 36, and 52

Notes
[2] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
Justification: The results were analyzed using non-responder imputation (NRI).

End point values	RPR-Placebo	RPR-Bari 2-mg	RPR-Bari 4-mg
Number of subjects analysed	34	53	63
Units: participants
number (not applicable)
Week 16	16	24	20
Week 36	14	13	19
Week 52	10	16	20

No statistical analyses for this end point

Secondary: RPR: Number of Participants From Monotherapy Studies (JAHL, JAHM) Who Achieved a Response of IGA 0, 1 or 2

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End point title

RPR: Number of Participants From Monotherapy Studies (JAHL, JAHM) Who Achieved a Response of IGA 0, 1 or 2

End point description

The IGA measures the investigator's global assessment of the participant's overall severity of their atopic dermatitis (AD), based on a static, numeric 5-point scale from 0 (clear skin) to 4 (severe disease). The score is based on an overall assessment of the degree of erythema, papulation/induration, oozing/crusting, and lichenification. The results were analyzed using NRI. All participants who either discontinued the study treatment or discontinued the study for any reason at any time were defined as non-responders for the NRI analysis for categorical variables such as IGA 0/1/2. Modified Intent-to-treat Population: All RPR participants who received at least one dose of IP in JAHN. The participants here are from the previous Baricitinib monotherapy studies (JAHL and JAHM) as the results are presented as subsets of overall RPR population.

End point type

Secondary

End point timeframe

Weeks 16, 36, and 52

End point values	RPR-Placebo	RPR-Bari 1-mg	RPR-Bari 2-mg	RPR-Bari 4-mg
Number of subjects analysed	52	45	54	70
Units: participants
number (not applicable)
Week 16	36	35	44	51
Week 36	25	27	44	41
Week 52	24	24	39	41

No statistical analyses for this end point

Secondary: RPR: Number of Participants From Combination Therapy Study (JAIY) Who Achieved a Response of IGA 0, 1, or 2

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End point title

RPR: Number of Participants From Combination Therapy Study (JAIY) Who Achieved a Response of IGA 0, 1, or 2

End point description

The IGA measures the investigator's global assessment of the participant's overall severity of their atopic dermatitis (AD), based on a static, numeric 5-point scale from 0 (clear skin) to 4 (severe disease). The score is based on an overall assessment of the degree of erythema, papulation/induration, oozing/crusting, and lichenification. The results were analyzed using NRI. All participants who either discontinued the study treatment or discontinued the study for any reason at any time were defined as non-responders for the NRI analysis for categorical variables such as IGA 0/1/2. Modified Intent-to-treat Population: All RPR participants who received at least one dose of IP in JAHN. The participants here are from the previous Baricitinib combination therapy study (JAIY) as the results are presented as subsets of overall RPR population.

End point type

Secondary

End point timeframe

Weeks 16, 36, and 52

End point values	Placebo	Bari 2 mg	Bari 4 mg
Number of subjects analysed	34	53	63
Units: participants
number (not applicable)
Week 16	24	39	40
Week 36	19	26	33
Week 52	17	29	33

No statistical analyses for this end point

Secondary: Non Responders (NR): Number of Baricitinib NR Participants From Monotherapy Studies (JAHL, JAHM) Who Achieved a Response of IGA 0, 1 or 2

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End point title

Non Responders (NR): Number of Baricitinib NR Participants From Monotherapy Studies (JAHL, JAHM) Who Achieved a Response of IGA 0, 1 or 2

End point description

The IGA measures the investigator's global assessment of the participant's overall severity of their atopic dermatitis (AD), based on a static, numeric 5-point scale from 0 (clear skin) to 4 (severe disease). The score is based on an overall assessment of the degree of erythema, papulation/induration, oozing/crusting, and lichenification. The results were analyzed using NRI. All participants who either discontinued the study treatment or discontinued the study for any reason at any time were defined as non-responders for the NRI analysis for categorical variables such as IGA 0/1/2. Modified Intent-to-treat Population: All NR participants who received at least one dose of IP in JAHN. The participants here are from previous the Baricitinib monotherapy studies (JAHL and JAHM) as the results are presented as subsets of overall NR population.

End point type

Secondary

End point timeframe

Weeks 16, 36 and 52

End point values	NR: Bari 1 mg to 2 mg	NR: Bari 1 mg to 4 mg	NR: Bari 2 mg to 2 mg	NR: Bari 2 mg to 4 mg	NR: Bari 4 mg to 4 mg
Number of subjects analysed	87	81	84	78	156
Units: participants
number (not applicable)
Week 16	40	45	40	34	63
Week 36	35	35	37	38	61
Week 52	27	39	37	30	64

No statistical analyses for this end point

Secondary: NR: Number of Baricitinib NR Participants From Combination Therapy Study (JAIY) Who Achieved a Response of IGA 0, 1 or 2

Top of page

End point title

NR: Number of Baricitinib NR Participants From Combination Therapy Study (JAIY) Who Achieved a Response of IGA 0, 1 or 2

End point description

The IGA measures the investigator's global assessment of the participant's overall severity of their atopic dermatitis (AD), based on a static, numeric 5-point scale from 0 (clear skin) to 4 (severe disease). The score is based on an overall assessment of the degree of erythema, papulation/induration, oozing/crusting, and lichenification. The results were analyzed using NRI. All participants who either discontinued the study treatment or discontinued the study for any reason at any time were defined as non-responders for the NRI analysis for categorical variables such as IGA 0/1/2. Modified Intent-to-treat Population: All NR participants who received at least one dose of IP in JAHN. The participants here are from previous the previous Baricitinib combination therapy study (JAIY) as the results are presented as subsets of overall NR population.

End point type

Secondary

End point timeframe

Weeks 16, 36, and 52

End point values	NR: Bari 2 mg to 2 mg	NR: Bari 2 mg to 4 mg	NR: Bari 4 mg to 4 mg
Number of subjects analysed	20	21	39
Units: participants
number (not applicable)
Week 16	7	12	12
Week 36	8	9	8
Week 52	9	9	11

No statistical analyses for this end point

Secondary: NR: Number of Baricitinib NR Participants From Monotherapy Studies (JAHL, JAHM) Who Achieved a Response of IGA 0 or 1

Top of page

End point title

NR: Number of Baricitinib NR Participants From Monotherapy Studies (JAHL, JAHM) Who Achieved a Response of IGA 0 or 1

End point description

The IGA measures the investigator's global assessment of the participant's overall severity of their atopic dermatitis (AD), based on a static, numeric 5-point scale from 0 (clear skin) to 4 (severe disease). The score is based on an overall assessment of the degree of erythema, papulation/induration, oozing/crusting, and lichenification. The results were analyzed using NRI. All participants who either discontinued the study treatment or discontinued the study for any reason at any time were defined as non-responders for the NRI analysis for categorical variables such as IGA 0/1. Modified Intent-to-treat Population: All NR participants who received at least one dose of IP in JAHN. The participants here are from previous the Baricitinib monotherapy studies (JAHL and JAHM) as the results are presented as subsets of overall NR population.

End point type

Secondary

End point timeframe

Weeks 16, 36, 52

End point values	NR: Bari 1 mg to 2 mg	NR: Bari 1 mg to 4 mg	NR: Bari 2 mg to 2 mg	NR: Bari 2 mg to 4 mg	NR: Bari 4 mg to 4 mg
Number of subjects analysed	87	81	84	78	156
Units: participants
number (not applicable)
Week 16	12	19	13	14	16
Week 36	12	10	9	13	26
Week 52	11	10	16	12	32

No statistical analyses for this end point

Secondary: NR: Number of Baricitinib NR Participants From Combination Therapy Study (JAIY) Who Achieved a Response of IGA 0 or 1

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End point title

NR: Number of Baricitinib NR Participants From Combination Therapy Study (JAIY) Who Achieved a Response of IGA 0 or 1

End point description

The IGA measures the investigator's global assessment of the participant's overall severity of their atopic dermatitis (AD), based on a static, numeric 5-point scale from 0 (clear skin) to 4 (severe disease). The score is based on an overall assessment of the degree of erythema, papulation/induration, oozing/crusting, and lichenification. The results were analyzed using NRI. All participants who either discontinued the study treatment or discontinued the study for any reason at any time were defined as non-responders for the NRI analysis for categorical variables such as IGA 0/1. Modified Intent-to-treat Population: All NR participants who received at least one dose of IP in JAHN. The participants here are from previous the previous Baricitinib combination therapy study (JAIY) as the results are presented as subsets of overall NR population.

End point type

Secondary

End point timeframe

Weeks 16, 36, and 52

End point values	NR: Bari 2 mg to 2 mg	NR: Bari 2 mg to 4 mg	NR: Bari 4 mg to 4 mg
Number of subjects analysed	20	21	39
Units: participants
number (not applicable)
Week 16	2	6	2
Week 36	3	5	6
Week 52	3	4	2

No statistical analyses for this end point

Secondary: RPR: Number of Participants From Monotherapy Studies (JAHL, JAHM) Who Achieved a Response of Eczema Area and Severity Index (EASI)75

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End point title

RPR: Number of Participants From Monotherapy Studies (JAHL, JAHM) Who Achieved a Response of Eczema Area and Severity Index (EASI)75

End point description

The EASI assesses objective physician estimates of 2 dimensions of atopic dermatitis - disease extent and clinical signs affected: 0 = 0%; 1 = 1-9%; 2 = 10-29%; 3 = 30-49%; 4 = 50-69%; 5 = 70-89%; 6 = 90-100% and the severity of 4 clinical signs: (1) erythema, (2) edema/papulation, (3) excoriation, and (4) lichenification each on a scale of 0 to 3 (0 = none, absent; 1 = mild; 2 = moderate; 3 = severe) at 4 body sites (head/neck, trunk, upper limbs, and lower limbs). The final EASI score was obtained by weight-averaging these 4 scores and will range from 0 to 72 (severe). The EASI75 is defined as a ≥ 75% improvement from baseline in the EASI score. The results were analyzed using NRI. Modified Intent-to-treat Population: All RPR participants who received at least one dose of IP in JAHN. The participants here are from the previous Baricitinib monotherapy studies (JAHL and JAHM) as the results are presented as subsets of overall RPR population.

End point type

Secondary

End point timeframe

Weeks 16, 36, and 52

End point values	RPR-Placebo	RPR-Bari 1-mg	RPR-Bari 2-mg	RPR-Bari 4-mg
Number of subjects analysed	52	45	54	70
Units: participants
number (not applicable)
Week 16	22	28	38	45
Week 36	23	21	40	36
Week 52	20	23	35	36

No statistical analyses for this end point

Secondary: RPR: Number of Participants From Combination Therapy Study (JAIY) Who Achieved a Response of EASI 75

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End point title

RPR: Number of Participants From Combination Therapy Study (JAIY) Who Achieved a Response of EASI 75

End point description

The EASI assesses objective physician estimates of 2 dimensions of atopic dermatitis - disease extent and clinical signs affected: 0 = 0%; 1 = 1-9%; 2 = 10-29%; 3 = 30-49%; 4 = 50-69%; 5 = 70-89%; 6 = 90-100% and the severity of 4 clinical signs: (1) erythema, (2) edema/papulation, (3) excoriation, and (4) lichenification each on a scale of 0 to 3 (0 = none, absent; 1 = mild; 2 = moderate; 3 = severe) at 4 body sites (head/neck, trunk, upper limbs, and lower limbs). The final EASI score was obtained by weight-averaging these 4 scores and will range from 0 to 72 (severe). The EASI75 is defined as a ≥ 75% improvement from baseline in the EASI score. The results were analyzed using NRI. Modified Intent-to-treat Population: All RPR participants who received at least one dose of IP in JAHN. The participants here are from the previous Baricitinib combination therapy study (JAIY) as the results are presented as subsets of overall RPR population.

End point type

Secondary

End point timeframe

Weeks 16, 36, and 52

End point values	RPR-Placebo	RPR-Bari 2-mg	RPR-Bari 4-mg
Number of subjects analysed	34	53	63
Units: participants
number (not applicable)
Week 16	19	36	35
Week 36	16	25	28
Week 52	13	28	27

No statistical analyses for this end point

Secondary: NR: Number of Baricitinib NR Participants From Monotherapy Studies (JAHL, JAHM) Who Achieved a Response of EASI 75

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End point title

NR: Number of Baricitinib NR Participants From Monotherapy Studies (JAHL, JAHM) Who Achieved a Response of EASI 75

End point description

The EASI assesses objective physician estimates of 2 dimensions of atopic dermatitis - disease extent and clinical signs affected: 0 = 0%; 1 = 1-9%; 2 = 10-29%; 3 = 30-49%; 4 = 50-69%; 5 = 70-89%; 6 = 90-100% and the severity of 4 clinical signs: (1) erythema, (2) edema/papulation, (3) excoriation, and (4) lichenification each on a scale of 0 to 3 (0 = none, absent; 1 = mild; 2 = moderate; 3 = severe) at 4 body sites (head/neck, trunk, upper limbs, and lower limbs). The final EASI score was obtained by weight-averaging these 4 scores and will range from 0 to 72 (severe). The EASI75 is defined as a ≥ 75% improvement from baseline in the EASI score. The results were analyzed using NRI. Modified Intent-to-treat Population: All NR participants who received at least one dose of IP in JAHN. The participants here are from previous the Baricitinib monotherapy studies (JAHL and JAHM) as the results are presented as subsets of overall NR population.

End point type

Secondary

End point timeframe

Weeks 16, 36, and 52

End point values	NR: Bari 1 mg to 2 mg	NR: Bari 1 mg to 4 mg	NR: Bari 2 mg to 2 mg	NR: Bari 2 mg to 4 mg	NR: Bari 4 mg to 4 mg
Number of subjects analysed	87	81	84	78	156
Units: participants
number (not applicable)
Week 16	29	35	32	30	42
Week 36	28	25	26	35	48
Week 52	25	29	29	27	52

No statistical analyses for this end point

Secondary: NR: Number of Baricitinib NR Participants From Combination Therapy Study (JAIY) Who Achieved a Response of EASI 75

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End point title

NR: Number of Baricitinib NR Participants From Combination Therapy Study (JAIY) Who Achieved a Response of EASI 75

End point description

The EASI assesses objective physician estimates of 2 dimensions of atopic dermatitis - disease extent and clinical signs affected: 0 = 0%; 1 = 1-9%; 2 = 10-29%; 3 = 30-49%; 4 = 50-69%; 5 = 70-89%; 6 = 90-100% and the severity of 4 clinical signs: (1) erythema, (2) edema/papulation, (3) excoriation, and (4) lichenification each on a scale of 0 to 3 (0 = none, absent; 1 = mild; 2 = moderate; 3 = severe) at 4 body sites (head/neck, trunk, upper limbs, and lower limbs). The final EASI score was obtained by weight-averaging these 4 scores and will range from 0 to 72 (severe). The EASI75 is defined as a ≥ 75% improvement from baseline in the EASI score. The results were analyzed using NRI. Modified Intent-to-treat Population: All NR participants who received at least one dose of IP in JAHN. The participants here are from previous the previous Baricitinib combination therapy study (JAIY) as the results are presented as subsets of overall NR population.

End point type

Secondary

End point timeframe

Weeks 16, 36, and 52

End point values	NR: Bari 2 mg to 2 mg	NR: Bari 2 mg to 4 mg	NR: Bari 4 mg to 4 mg
Number of subjects analysed	20	21	39
Units: participants
number (not applicable)
Week 16	4	12	11
Week 36	5	6	9
Week 52	4	6	11

No statistical analyses for this end point

Secondary: RPR: Number of Participants From Monotherapy Studies (JAHL, JAHM) Who Achieved 4-Point Improvement Itch Numeric Rating Scale (NRS)

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End point title

RPR: Number of Participants From Monotherapy Studies (JAHL, JAHM) Who Achieved 4-Point Improvement Itch Numeric Rating Scale (NRS)

End point description

The Itch NRS is a participant-administered, 11-point horizontal scale anchored at 0 and 10, with 0 representing "no itch" and 10 representing "worst itch imaginable." Overall severity of a participants itching is indicated by selecting the number, using a daily diary, that best describes the worst level of itching in the past 24 hours. The results were analyzed using NRI. All participants who either discontinued the study treatment or discontinued the study for any reason at any time were defined as non-responders for the NRI analysis for categorical variables such as NRS. Modified Intent-to-treat Population: All RPR participants who received at least one dose of IP in JAHN with Baseline Itch NRS Score >= 4. The participants here are from the previous Baricitinib monotherapy studies (JAHL and JAHM) as the results are presented as subsets of overall RPR population.

End point type

Secondary

End point timeframe

Week 16

End point values	RPR-Placebo	RPR-Bari 1-mg	RPR-Bari 2-mg	RPR-Bari 4-mg
Number of subjects analysed	43	31	43	61
Units: participants
number (not applicable)	14	8	14	25

No statistical analyses for this end point

Secondary: RPR: Number of Participants From Combination Therapy Study (JAIY) Who Achieved 4-Point Improvement in Itch NRS

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End point title

RPR: Number of Participants From Combination Therapy Study (JAIY) Who Achieved 4-Point Improvement in Itch NRS

End point description

The Itch NRS is a participant-administered, 11-point horizontal scale anchored at 0 and 10, with 0 representing "no itch" and 10 representing "worst itch imaginable." Overall severity of a participants itching is indicated by selecting the number, using a daily diary, that best describes the worst level of itching in the past 24 hours. The results were analyzed using NRI. All participants who either discontinued the study treatment or discontinued the study for any reason at any time were defined as non-responders for the NRI analysis for categorical variables such as NRS. Modified Intent-to-treat Population: All RPR participants who received at least one dose of IP in JAHN with Baseline Itch NRS Score >= 4. The participants here are from the previous Baricitinib combination therapy study (JAIY) as the results are presented as subsets of overall RPR population.

End point type

Secondary

End point timeframe

Week 16

End point values	Placebo	Bari 2 mg	Bari 4 mg
Number of subjects analysed	32	48	56
Units: participants
number (not applicable)	12	22	26

No statistical analyses for this end point

Secondary: NR: Number of Baricitinib NR Participants From Monotherapy Studies (JAHL, JAHM) Who Achieved 4-Point Improvement in Itch NRS

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End point title

NR: Number of Baricitinib NR Participants From Monotherapy Studies (JAHL, JAHM) Who Achieved 4-Point Improvement in Itch NRS

End point description

The Itch NRS is a participant-administered, 11-point horizontal scale anchored at 0 and 10, with 0 representing "no itch" and 10 representing "worst itch imaginable." Overall severity of a participants itching is indicated by selecting the number, using a daily diary, that best describes the worst level of itching in the past 24 hours. The results were analyzed using NRI. All participants who either discontinued the study treatment or discontinued the study for any reason at any time were defined as non-responders for the NRI analysis for categorical variables such as NRS. Modified Intent-to-treat Population: All NR participants who received at least one dose of IP in JAHN with Baseline Itch NRS Score >= 4. The participants here are from previous the Baricitinib monotherapy studies (JAHL and JAHM) as the results are presented as subsets of overall NR population.

End point type

Secondary

End point timeframe

Week 16

End point values	NR: Bari 1 mg to 2 mg	NR: Bari 1 mg to 4 mg	NR: Bari 2 mg to 2 mg	NR: Bari 2 mg to 4 mg	NR: Bari 4 mg to 4 mg
Number of subjects analysed	80	62	70	71	138
Units: participants
number (not applicable)	16	24	17	22	31

No statistical analyses for this end point

Secondary: NR: Number of Baricitinib NR Participants From Combination Therapy Study (JAIY) Who Achieved 4-Point Improvement in Itch NRS

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End point title

NR: Number of Baricitinib NR Participants From Combination Therapy Study (JAIY) Who Achieved 4-Point Improvement in Itch NRS

End point description

The Itch NRS is a participant-administered, 11-point horizontal scale anchored at 0 and 10, with 0 representing "no itch" and 10 representing "worst itch imaginable." Overall severity of a participants itching is indicated by selecting the number, using a daily diary, that best describes the worst level of itching in the past 24 hours. The results were analyzed using NRI. All participants who either discontinued the study treatment or discontinued the study for any reason at any time were defined as non-responders for the NRI analysis for categorical variables such as NRS. Modified Intent-to-treat Population: All NR participants who received at least one dose of IP in JAHN with Baseline Itch NRS Score >= 4. The participants here are from previous the previous Baricitinib combination therapy study (JAIY) as the results are presented as subsets of overall NR population.

End point type

Secondary

End point timeframe

Week 16

End point values	NR: Bari 2 mg to 2 mg	NR: Bari 2 mg to 4 mg	NR: Bari 4 mg to 4 mg
Number of subjects analysed	19	19	35
Units: participants
number (not applicable)	6	7	11

No statistical analyses for this end point

Secondary: NR: Number of Placebo NR Participants From Monotherapy Studies (JAHL, JAHM) Who Achieved a Response of IGA 0, 1 or 2

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End point title

NR: Number of Placebo NR Participants From Monotherapy Studies (JAHL, JAHM) Who Achieved a Response of IGA 0, 1 or 2

End point description

The IGA measures the investigator's global assessment of the participant's overall severity of their atopic dermatitis (AD), based on a static, numeric 5-point scale from 0 (clear skin) to 4 (severe disease). The score is based on an overall assessment of the degree of erythema, papulation/induration, oozing/crusting, and lichenification. The results were analyzed using NRI. All participants who either discontinued the study treatment or discontinued the study for any reason at any time were defined as non-responders for the NRI analysis for categorical variables such as IGA 0/1/2. Modified Intent-to-treat Population: All NR participants who received at least one dose of IP in JAHN. The participants here are from previous the Baricitinib monotherapy studies (JAHL and JAHM) as the results are presented as subsets of overall NR population.

End point type

Secondary

End point timeframe

Weeks 4, 16, 24, 52

End point values	NR: Placebo to Bari 2 mg	NR: Placebo to Bari 4 mg
Number of subjects analysed	180	194
Units: participants
number (not applicable)
Week 4	104	130
Week 16	102	122
Week 24	100	111
Week 52	91	91

No statistical analyses for this end point

Secondary: NR: Number of Placebo NR Participants From Combination Therapy Study (JAIY) Who Achieved a Response of IGA 0, 1 or 2

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End point title

NR: Number of Placebo NR Participants From Combination Therapy Study (JAIY) Who Achieved a Response of IGA 0, 1 or 2

End point description

The IGA measures the investigator's global assessment of the participant's overall severity of their atopic dermatitis (AD), based on a static, numeric 5-point scale from 0 (clear skin) to 4 (severe disease). The score is based on an overall assessment of the degree of erythema, papulation/induration, oozing/crusting, and lichenification. The results were analyzed using NRI. All participants who either discontinued the study treatment or discontinued the study for any reason at any time were defined as non-responders for the NRI analysis for categorical variables such as IGA 0/1/2. Modified Intent-to-treat Population: All NR participants who received at least one dose of IP in JAHN. The participants here are from previous the previous Baricitinib combination therapy study (JAIY) as the results are presented as subsets of overall NR population.

End point type

Secondary

End point timeframe

Weeks 4, 16, 24, 52

End point values	NR: Placebo to Bari 2 mg	NR: Placebo to Bari 4 mg
Number of subjects analysed	34	28
Units: participants
number (not applicable)
Week 4	17	13
Week 16	16	13
Week 24	13	11
Week 52	9	7

No statistical analyses for this end point

Secondary: NR: Number of Placebo NR Participants From Monotherapy Studies (JAHL, JAHM) Who Achieved a Response of IGA 0 or 1

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End point title

NR: Number of Placebo NR Participants From Monotherapy Studies (JAHL, JAHM) Who Achieved a Response of IGA 0 or 1

End point description

The IGA measures the investigator's global assessment of the participant's overall severity of their atopic dermatitis (AD), based on a static, numeric 5-point scale from 0 (clear skin) to 4 (severe disease). The score is based on an overall assessment of the degree of erythema, papulation/induration, oozing/crusting, and lichenification. The results were analyzed using NRI. All participants who either discontinued the study treatment or discontinued the study for any reason at any time were defined as non-responders for the NRI analysis for categorical variables such as IGA 0/1. Modified Intent-to-treat Population: All NR participants who received at least one dose of IP in JAHN. The participants here are from previous the Baricitinib monotherapy studies (JAHL and JAHM) as the results are presented as subsets of overall NR population.

End point type

Secondary

End point timeframe

Weeks 4, 16, 24, 52

End point values	NR: Placebo to Bari 2 mg	NR: Placebo to Bari 4 mg
Number of subjects analysed	180	194
Units: participants
number (not applicable)
Week 4	41	50
Week 16	40	58
Week 24	40	54
Week 52	37	46

No statistical analyses for this end point

Secondary: NR: Number of Placebo NR Participants From Combination Therapy Study (JAIY) Who Achieved a Response of IGA 0 or 1

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End point title

NR: Number of Placebo NR Participants From Combination Therapy Study (JAIY) Who Achieved a Response of IGA 0 or 1

End point description

The IGA measures the investigator's global assessment of the participant's overall severity of their atopic dermatitis (AD), based on a static, numeric 5-point scale from 0 (clear skin) to 4 (severe disease). The score is based on an overall assessment of the degree of erythema, papulation/induration, oozing/crusting, and lichenification. The results were analyzed using NRI. All participants who either discontinued the study treatment or discontinued the study for any reason at any time were defined as non-responders for the NRI analysis for categorical variables such as IGA 0/1. Modified Intent-to-treat Population: All NR participants who received at least one dose of IP in JAHN. The participants here are from previous the previous Baricitinib combination therapy study (JAIY) as the results are presented as subsets of overall NR population.

End point type

Secondary

End point timeframe

Weeks 4, 16, 24, 52

End point values	NR: Placebo to Bari 2 mg	NR: Placebo to Bari 4 mg
Number of subjects analysed	34	28
Units: participants
number (not applicable)
Week 4	0	4
Week 16	2	7
Week 24	4	5
Week 52	2	3

No statistical analyses for this end point

Secondary: NR: Number of Placebo NR Participants From Monotherapy Studies (JAHL, JAHM) Who Achieved a Response of EASI 75

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End point title

NR: Number of Placebo NR Participants From Monotherapy Studies (JAHL, JAHM) Who Achieved a Response of EASI 75

End point description

The EASI assesses objective physician estimates of 2 dimensions of atopic dermatitis - disease extent and clinical signs affected: 0 = 0%; 1 = 1-9%; 2 = 10-29%; 3 = 30-49%; 4 = 50-69%; 5 = 70-89%; 6 = 90-100% and the severity of 4 clinical signs: (1) erythema, (2) edema/papulation, (3) excoriation, and (4) lichenification each on a scale of 0 to 3 (0 = none, absent; 1 = mild; 2 = moderate; 3 = severe) at 4 body sites (head/neck, trunk, upper limbs, and lower limbs). The final EASI score was obtained by weight-averaging these 4 scores and will range from 0 to 72 (severe). The EASI75 is defined as a ≥ 75% improvement from baseline in the EASI score. The results were analyzed using NRI. Modified Intent-to-treat Population: All NR participants who received at least one dose of IP in JAHN. The participants here are from previous the Baricitinib monotherapy studies (JAHL and JAHM) as the results are presented as subsets of overall NR population.

End point type

Secondary

End point timeframe

Weeks 4, 16, 24, 52

End point values	NR: Placebo to Bari 2 mg	NR: Placebo to Bari 4 mg
Number of subjects analysed	180	194
Units: participants
number (not applicable)
Week 4	70	91
Week 16	79	104
Week 24	81	88
Week 52	74	75

No statistical analyses for this end point

Secondary: NR: Number of Placebo NR Participants From Combination Therapy Study (JAIY) Who Achieved a Response of EASI 75

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End point title

NR: Number of Placebo NR Participants From Combination Therapy Study (JAIY) Who Achieved a Response of EASI 75

End point description

The EASI assesses objective physician estimates of 2 dimensions of atopic dermatitis - disease extent and clinical signs affected: 0 = 0%; 1 = 1-9%; 2 = 10-29%; 3 = 30-49%; 4 = 50-69%; 5 = 70-89%; 6 = 90-100% and the severity of 4 clinical signs: (1) erythema, (2) edema/papulation, (3) excoriation, and (4) lichenification each on a scale of 0 to 3 (0 = none, absent; 1 = mild; 2 = moderate; 3 = severe) at 4 body sites (head/neck, trunk, upper limbs, and lower limbs). The final EASI score was obtained by weight-averaging these 4 scores and will range from 0 to 72 (severe). The EASI75 is defined as a ≥ 75% improvement from baseline in the EASI score. The results were analyzed using NRI. Modified Intent-to-treat Population: All NR participants who received at least one dose of IP in JAHN. The participants here are from previous the previous Baricitinib combination therapy study (JAIY) as the results are presented as subsets of overall NR population.

End point type

Secondary

End point timeframe

Weeks 4, 16, 24, 52

End point values	NR: Placebo to Bari 2 mg	NR: Placebo to Bari 4 mg
Number of subjects analysed	34	28
Units: participants
number (not applicable)
Week 4	8	11
Week 16	13	11
Week 24	11	9
Week 52	9	9

No statistical analyses for this end point

Secondary: NR: Number of Placebo NR Participants From Monotherapy Studies (JAHL, JAHM) Who Achieved 4-Point Improvement in Itch NRS

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End point title

NR: Number of Placebo NR Participants From Monotherapy Studies (JAHL, JAHM) Who Achieved 4-Point Improvement in Itch NRS

End point description

The Itch NRS is a participant-administered, 11-point horizontal scale anchored at 0 and 10, with 0 representing "no itch" and 10 representing "worst itch imaginable." Overall severity of a participants itching is indicated by selecting the number, using a daily diary, that best describes the worst level of itching in the past 24 hours. The results were analyzed using NRI. All participants who either discontinued the study treatment or discontinued the study for any reason at any time were defined as non-responders for the NRI analysis for categorical variables such as NRS. Modified Intent-to-treat Population: All NR participants who received at least one dose of IP in JAHN with Baseline Itch NRS Score >= 4. The participants here are from previous the Baricitinib monotherapy studies (JAHL and JAHM) as the results are presented as subsets of overall NR population.

End point type

Secondary

End point timeframe

Week 16

End point values	NR: Placebo to Bari 2 mg	NR: Placebo to Bari 4 mg
Number of subjects analysed	165	171
Units: participants
number (not applicable)	56	61

No statistical analyses for this end point

Secondary: NR: Number of Placebo NR Participants From Combination Therapy Study (JAIY) Who Achieved 4-Point Improvement in Itch NRS

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End point title

NR: Number of Placebo NR Participants From Combination Therapy Study (JAIY) Who Achieved 4-Point Improvement in Itch NRS

End point description

The Itch NRS is a participant-administered, 11-point horizontal scale anchored at 0 and 10, with 0 representing "no itch" and 10 representing "worst itch imaginable." Overall severity of a participants itching is indicated by selecting the number, using a daily diary, that best describes the worst level of itching in the past 24 hours. The results were analyzed using NRI. All participants who either discontinued the study treatment or discontinued the study for any reason at any time were defined as non-responders for the NRI analysis for categorical variables such as NRS. Modified Intent-to-treat Population: All NR participants who received at least one dose of IP in JAHN with Baseline Itch NRS Score >= 4. The participants here are from previous the previous Baricitinib combination therapy study (JAIY) as the results are presented as subsets of overall NR population.

End point type

Secondary

End point timeframe

Week 16

End point values	NR: Placebo to Bari 2 mg	NR: Placebo to Bari 4 mg
Number of subjects analysed	34	26
Units: participants
number (not applicable)	7	7

No statistical analyses for this end point

Adverse events

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Timeframe for reporting adverse events

Baseline through Week 52

Adverse event reporting additional description

All participants who received at least one dose of IP. The participants from open label arm were included in the Baricitinib 2-mg arm while reporting the safety data. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly

Assessment type

Systematic

Dictionary name

MedDRA

Dictionary version

22.1

Reporting group title

Placebo

Reporting group description

Reporting group title

Bari-2mg

Reporting group description

Reporting group title

Bari-4mg

Reporting group description

Reporting group title

Bari-1mg

Reporting group description

Serious adverse events	Placebo	Bari-2mg	Bari-4mg	Bari-1mg
Total subjects affected by serious adverse events
subjects affected / exposed	5 / 91 (5.49%)	33 / 766 (4.31%)	40 / 743 (5.38%)	1 / 45 (2.22%)
number of deaths (all causes)	0	0	1	0
number of deaths resulting from adverse events	0	0	0	0
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
anaplastic large cell lymphoma t- and null-cell types
alternative dictionary used: MedDRA 22.1
subjects affected / exposed	0 / 91 (0.00%)	0 / 766 (0.00%)	1 / 743 (0.13%)	0 / 45 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	1 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
bladder neoplasm
alternative dictionary used: MedDRA 22.1
subjects affected / exposed	0 / 91 (0.00%)	1 / 766 (0.13%)	0 / 743 (0.00%)	0 / 45 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
rectal cancer
alternative dictionary used: MedDRA 22.1
subjects affected / exposed	0 / 91 (0.00%)	1 / 766 (0.13%)	0 / 743 (0.00%)	0 / 45 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
squamous cell carcinoma
alternative dictionary used: MedDRA 22.1
subjects affected / exposed	0 / 91 (0.00%)	0 / 766 (0.00%)	1 / 743 (0.13%)	0 / 45 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Vascular disorders
thrombophlebitis
alternative dictionary used: MedDRA 22.1
subjects affected / exposed	0 / 91 (0.00%)	0 / 766 (0.00%)	2 / 743 (0.27%)	0 / 45 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	2 / 2	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
vasculitis
alternative dictionary used: MedDRA 22.1
subjects affected / exposed	0 / 91 (0.00%)	0 / 766 (0.00%)	1 / 743 (0.13%)	0 / 45 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	1 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Immune system disorders
anaphylactic reaction
alternative dictionary used: MedDRA 22.1
subjects affected / exposed	0 / 91 (0.00%)	1 / 766 (0.13%)	0 / 743 (0.00%)	0 / 45 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Reproductive system and breast disorders
uterine haemorrhage
alternative dictionary used: MedDRA 22.1
subjects affected / exposed ^[1]	1 / 44 (2.27%)	0 / 318 (0.00%)	0 / 239 (0.00%)	0 / 16 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Respiratory, thoracic and mediastinal disorders
epistaxis
alternative dictionary used: MedDRA 22.1
subjects affected / exposed	0 / 91 (0.00%)	0 / 766 (0.00%)	1 / 743 (0.13%)	0 / 45 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
pulmonary embolism
alternative dictionary used: MedDRA 22.1
subjects affected / exposed	0 / 91 (0.00%)	0 / 766 (0.00%)	1 / 743 (0.13%)	0 / 45 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	1 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Injury, poisoning and procedural complications
ankle fracture
alternative dictionary used: MedDRA 22.1
subjects affected / exposed	0 / 91 (0.00%)	1 / 766 (0.13%)	0 / 743 (0.00%)	0 / 45 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
contusion
alternative dictionary used: MedDRA 22.1
subjects affected / exposed	1 / 91 (1.10%)	0 / 766 (0.00%)	0 / 743 (0.00%)	0 / 45 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
facial bones fracture
alternative dictionary used: MedDRA 22.1
subjects affected / exposed	0 / 91 (0.00%)	0 / 766 (0.00%)	1 / 743 (0.13%)	0 / 45 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
fall
alternative dictionary used: MedDRA 22.1
subjects affected / exposed	0 / 91 (0.00%)	1 / 766 (0.13%)	0 / 743 (0.00%)	0 / 45 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
foot fracture
alternative dictionary used: MedDRA 22.1
subjects affected / exposed	0 / 91 (0.00%)	0 / 766 (0.00%)	1 / 743 (0.13%)	0 / 45 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
joint dislocation
alternative dictionary used: MedDRA 22.1
subjects affected / exposed	0 / 91 (0.00%)	1 / 766 (0.13%)	0 / 743 (0.00%)	0 / 45 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
ligament sprain
alternative dictionary used: MedDRA 22.1
subjects affected / exposed	0 / 91 (0.00%)	1 / 766 (0.13%)	0 / 743 (0.00%)	0 / 45 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
limb injury
alternative dictionary used: MedDRA 22.1
subjects affected / exposed	0 / 91 (0.00%)	1 / 766 (0.13%)	0 / 743 (0.00%)	0 / 45 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
meniscus injury
alternative dictionary used: MedDRA 22.1
subjects affected / exposed	0 / 91 (0.00%)	1 / 766 (0.13%)	0 / 743 (0.00%)	0 / 45 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
multiple injuries
alternative dictionary used: MedDRA 22.1
subjects affected / exposed	0 / 91 (0.00%)	1 / 766 (0.13%)	0 / 743 (0.00%)	0 / 45 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
road traffic accident
alternative dictionary used: MedDRA 22.1
subjects affected / exposed	0 / 91 (0.00%)	0 / 766 (0.00%)	1 / 743 (0.13%)	0 / 45 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
tibia fracture
alternative dictionary used: MedDRA 22.1
subjects affected / exposed	0 / 91 (0.00%)	0 / 766 (0.00%)	1 / 743 (0.13%)	0 / 45 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Cardiac disorders
myocarditis
alternative dictionary used: MedDRA 22.1
subjects affected / exposed	0 / 91 (0.00%)	1 / 766 (0.13%)	0 / 743 (0.00%)	0 / 45 (0.00%)
occurrences causally related to treatment / all	0 / 0	1 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
sinus tachycardia
alternative dictionary used: MedDRA 22.1
subjects affected / exposed	0 / 91 (0.00%)	0 / 766 (0.00%)	1 / 743 (0.13%)	0 / 45 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	1 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
supraventricular tachycardia
alternative dictionary used: MedDRA 22.1
subjects affected / exposed	0 / 91 (0.00%)	0 / 766 (0.00%)	1 / 743 (0.13%)	0 / 45 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
ventricular extrasystoles
alternative dictionary used: MedDRA 22.1
subjects affected / exposed	0 / 91 (0.00%)	0 / 766 (0.00%)	1 / 743 (0.13%)	0 / 45 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	1 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Nervous system disorders
dizziness
alternative dictionary used: MedDRA 22.1
subjects affected / exposed	0 / 91 (0.00%)	0 / 766 (0.00%)	1 / 743 (0.13%)	0 / 45 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Ear and labyrinth disorders
tinnitus
alternative dictionary used: MedDRA 22.1
subjects affected / exposed	0 / 91 (0.00%)	0 / 766 (0.00%)	1 / 743 (0.13%)	0 / 45 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Eye disorders
retinal detachment
alternative dictionary used: MedDRA 22.1
subjects affected / exposed	0 / 91 (0.00%)	0 / 766 (0.00%)	1 / 743 (0.13%)	0 / 45 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
retinopathy proliferative
alternative dictionary used: MedDRA 22.1
subjects affected / exposed	0 / 91 (0.00%)	0 / 766 (0.00%)	1 / 743 (0.13%)	0 / 45 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
rhegmatogenous retinal detachment
alternative dictionary used: MedDRA 22.1
subjects affected / exposed	0 / 91 (0.00%)	0 / 766 (0.00%)	1 / 743 (0.13%)	0 / 45 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Gastrointestinal disorders
colitis
alternative dictionary used: MedDRA 22.1
subjects affected / exposed	0 / 91 (0.00%)	0 / 766 (0.00%)	1 / 743 (0.13%)	0 / 45 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	1 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
gastrointestinal haemorrhage
alternative dictionary used: MedDRA 22.1
subjects affected / exposed	0 / 91 (0.00%)	0 / 766 (0.00%)	1 / 743 (0.13%)	0 / 45 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 1	0 / 0
intestinal obstruction
alternative dictionary used: MedDRA 22.1
subjects affected / exposed	0 / 91 (0.00%)	1 / 766 (0.13%)	0 / 743 (0.00%)	0 / 45 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
pancreatic failure
alternative dictionary used: MedDRA 22.1
subjects affected / exposed	0 / 91 (0.00%)	1 / 766 (0.13%)	0 / 743 (0.00%)	0 / 45 (0.00%)
occurrences causally related to treatment / all	0 / 0	1 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
pancreatitis
alternative dictionary used: MedDRA 22.1
subjects affected / exposed	0 / 91 (0.00%)	1 / 766 (0.13%)	0 / 743 (0.00%)	0 / 45 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Hepatobiliary disorders
cholelithiasis
alternative dictionary used: MedDRA 22.1
subjects affected / exposed	0 / 91 (0.00%)	0 / 766 (0.00%)	1 / 743 (0.13%)	0 / 45 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
drug-induced liver injury
alternative dictionary used: MedDRA 22.1
subjects affected / exposed	1 / 91 (1.10%)	0 / 766 (0.00%)	0 / 743 (0.00%)	0 / 45 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
hepatic failure
alternative dictionary used: MedDRA 22.1
subjects affected / exposed	0 / 91 (0.00%)	1 / 766 (0.13%)	0 / 743 (0.00%)	0 / 45 (0.00%)
occurrences causally related to treatment / all	0 / 0	1 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Skin and subcutaneous tissue disorders
dermatitis atopic
alternative dictionary used: MedDRA 22.1
subjects affected / exposed	1 / 91 (1.10%)	11 / 766 (1.44%)	9 / 743 (1.21%)	0 / 45 (0.00%)
occurrences causally related to treatment / all	0 / 1	3 / 15	6 / 12	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
dermatitis exfoliative
alternative dictionary used: MedDRA 22.1
subjects affected / exposed	0 / 91 (0.00%)	1 / 766 (0.13%)	0 / 743 (0.00%)	0 / 45 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
parakeratosis
alternative dictionary used: MedDRA 22.1
subjects affected / exposed	1 / 91 (1.10%)	0 / 766 (0.00%)	0 / 743 (0.00%)	0 / 45 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
urticaria
alternative dictionary used: MedDRA 22.1
subjects affected / exposed	0 / 91 (0.00%)	1 / 766 (0.13%)	0 / 743 (0.00%)	0 / 45 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Renal and urinary disorders
calculus urinary
alternative dictionary used: MedDRA 22.1
subjects affected / exposed	0 / 91 (0.00%)	0 / 766 (0.00%)	1 / 743 (0.13%)	0 / 45 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
renal colic
alternative dictionary used: MedDRA 22.1
subjects affected / exposed	0 / 91 (0.00%)	0 / 766 (0.00%)	1 / 743 (0.13%)	0 / 45 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
renal failure
alternative dictionary used: MedDRA 22.1
subjects affected / exposed	0 / 91 (0.00%)	1 / 766 (0.13%)	0 / 743 (0.00%)	0 / 45 (0.00%)
occurrences causally related to treatment / all	0 / 0	1 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Musculoskeletal and connective tissue disorders
bursitis
alternative dictionary used: MedDRA 22.1
subjects affected / exposed	0 / 91 (0.00%)	1 / 766 (0.13%)	0 / 743 (0.00%)	0 / 45 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
compartment syndrome
alternative dictionary used: MedDRA 22.1
subjects affected / exposed	0 / 91 (0.00%)	0 / 766 (0.00%)	1 / 743 (0.13%)	0 / 45 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
intervertebral disc protrusion
alternative dictionary used: MedDRA 22.1
subjects affected / exposed	0 / 91 (0.00%)	0 / 766 (0.00%)	1 / 743 (0.13%)	0 / 45 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
osteonecrosis
alternative dictionary used: MedDRA 22.1
subjects affected / exposed	0 / 91 (0.00%)	0 / 766 (0.00%)	1 / 743 (0.13%)	0 / 45 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Infections and infestations
abscess jaw
alternative dictionary used: MedDRA 22.1
subjects affected / exposed	0 / 91 (0.00%)	1 / 766 (0.13%)	0 / 743 (0.00%)	0 / 45 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
appendicitis
alternative dictionary used: MedDRA 22.1
subjects affected / exposed	0 / 91 (0.00%)	0 / 766 (0.00%)	0 / 743 (0.00%)	1 / 45 (2.22%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
arthritis infective
alternative dictionary used: MedDRA 22.1
subjects affected / exposed	0 / 91 (0.00%)	0 / 766 (0.00%)	1 / 743 (0.13%)	0 / 45 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
bacteraemia
alternative dictionary used: MedDRA 22.1
subjects affected / exposed	0 / 91 (0.00%)	1 / 766 (0.13%)	0 / 743 (0.00%)	0 / 45 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
bronchitis
alternative dictionary used: MedDRA 22.1
subjects affected / exposed	0 / 91 (0.00%)	1 / 766 (0.13%)	0 / 743 (0.00%)	0 / 45 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
cellulitis
alternative dictionary used: MedDRA 22.1
subjects affected / exposed	0 / 91 (0.00%)	0 / 766 (0.00%)	2 / 743 (0.27%)	0 / 45 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 2	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
diverticulitis
alternative dictionary used: MedDRA 22.1
subjects affected / exposed	0 / 91 (0.00%)	0 / 766 (0.00%)	1 / 743 (0.13%)	0 / 45 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	1 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
eczema herpeticum
alternative dictionary used: MedDRA 22.1
subjects affected / exposed	0 / 91 (0.00%)	2 / 766 (0.26%)	6 / 743 (0.81%)	0 / 45 (0.00%)
occurrences causally related to treatment / all	0 / 0	2 / 2	5 / 6	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
endophthalmitis
alternative dictionary used: MedDRA 22.1
subjects affected / exposed	0 / 91 (0.00%)	0 / 766 (0.00%)	1 / 743 (0.13%)	0 / 45 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
erysipelas
alternative dictionary used: MedDRA 22.1
subjects affected / exposed	0 / 91 (0.00%)	0 / 766 (0.00%)	1 / 743 (0.13%)	0 / 45 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	1 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
influenza
alternative dictionary used: MedDRA 22.1
subjects affected / exposed	0 / 91 (0.00%)	1 / 766 (0.13%)	0 / 743 (0.00%)	0 / 45 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
osteomyelitis
alternative dictionary used: MedDRA 22.1
subjects affected / exposed	0 / 91 (0.00%)	1 / 766 (0.13%)	0 / 743 (0.00%)	0 / 45 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
otitis externa
alternative dictionary used: MedDRA 22.1
subjects affected / exposed	0 / 91 (0.00%)	0 / 766 (0.00%)	1 / 743 (0.13%)	0 / 45 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
parainfluenzae virus infection
alternative dictionary used: MedDRA 22.1
subjects affected / exposed	1 / 91 (1.10%)	0 / 766 (0.00%)	0 / 743 (0.00%)	0 / 45 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
pneumonia
alternative dictionary used: MedDRA 22.1
subjects affected / exposed	0 / 91 (0.00%)	1 / 766 (0.13%)	0 / 743 (0.00%)	0 / 45 (0.00%)
occurrences causally related to treatment / all	0 / 0	1 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
postoperative wound infection
alternative dictionary used: MedDRA 22.1
subjects affected / exposed	1 / 91 (1.10%)	0 / 766 (0.00%)	0 / 743 (0.00%)	0 / 45 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
psoas abscess
alternative dictionary used: MedDRA 22.1
subjects affected / exposed	0 / 91 (0.00%)	0 / 766 (0.00%)	1 / 743 (0.13%)	0 / 45 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	1 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
pyelonephritis
alternative dictionary used: MedDRA 22.1
subjects affected / exposed	0 / 91 (0.00%)	1 / 766 (0.13%)	0 / 743 (0.00%)	0 / 45 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
sinusitis
alternative dictionary used: MedDRA 22.1
subjects affected / exposed	0 / 91 (0.00%)	0 / 766 (0.00%)	1 / 743 (0.13%)	0 / 45 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
skin bacterial infection
alternative dictionary used: MedDRA 22.1
subjects affected / exposed	0 / 91 (0.00%)	1 / 766 (0.13%)	1 / 743 (0.13%)	0 / 45 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	2 / 2	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
staphylococcal bacteraemia
alternative dictionary used: MedDRA 22.1
subjects affected / exposed	0 / 91 (0.00%)	0 / 766 (0.00%)	1 / 743 (0.13%)	0 / 45 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	1 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
staphylococcal skin infection
alternative dictionary used: MedDRA 22.1
subjects affected / exposed	0 / 91 (0.00%)	0 / 766 (0.00%)	1 / 743 (0.13%)	0 / 45 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	1 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
superinfection bacterial
alternative dictionary used: MedDRA 22.1
subjects affected / exposed	0 / 91 (0.00%)	0 / 766 (0.00%)	2 / 743 (0.27%)	0 / 45 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	2 / 2	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
syphilis
alternative dictionary used: MedDRA 22.1
subjects affected / exposed	0 / 91 (0.00%)	0 / 766 (0.00%)	1 / 743 (0.13%)	0 / 45 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0
Metabolism and nutrition disorders
dairy intolerance
alternative dictionary used: MedDRA 22.1
subjects affected / exposed	0 / 91 (0.00%)	1 / 766 (0.13%)	0 / 743 (0.00%)	0 / 45 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0

Notes
[1] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed to this adverse event. These numbers are expected to be equal.
Justification: The denominator was adjusted because it was a gender-specific event for females.

Frequency threshold for reporting non-serious adverse events: 5%

Non-serious adverse events	Placebo	Bari-2mg	Bari-4mg	Bari-1mg
Total subjects affected by non serious adverse events
subjects affected / exposed	22 / 91 (24.18%)	229 / 766 (29.90%)	243 / 743 (32.71%)	16 / 45 (35.56%)
Nervous system disorders
headache
alternative dictionary used: MedDRA 22.1
subjects affected / exposed	7 / 91 (7.69%)	48 / 766 (6.27%)	22 / 743 (2.96%)	1 / 45 (2.22%)
occurrences all number	7	60	37	1
General disorders and administration site conditions
pyrexia
alternative dictionary used: MedDRA 22.1
subjects affected / exposed	0 / 91 (0.00%)	19 / 766 (2.48%)	19 / 743 (2.56%)	3 / 45 (6.67%)
occurrences all number	0	20	20	3
Infections and infestations
herpes simplex
alternative dictionary used: MedDRA 22.1
subjects affected / exposed	5 / 91 (5.49%)	20 / 766 (2.61%)	34 / 743 (4.58%)	1 / 45 (2.22%)
occurrences all number	5	31	41	1
nasopharyngitis
alternative dictionary used: MedDRA 22.1
subjects affected / exposed	11 / 91 (12.09%)	110 / 766 (14.36%)	128 / 743 (17.23%)	10 / 45 (22.22%)
occurrences all number	13	147	180	18
oral herpes
alternative dictionary used: MedDRA 22.1
subjects affected / exposed	2 / 91 (2.20%)	34 / 766 (4.44%)	41 / 743 (5.52%)	1 / 45 (2.22%)
occurrences all number	3	49	55	2
upper respiratory tract infection
alternative dictionary used: MedDRA 22.1
subjects affected / exposed	3 / 91 (3.30%)	44 / 766 (5.74%)	45 / 743 (6.06%)	1 / 45 (2.22%)
occurrences all number	3	66	57	1

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Were there any global substantial amendments to the protocol? Yes

27 Nov 2019

Substantial Amendment (c): - Included an additional six visits to reflect the 2-year extension to the study. - Updated discontinuation criteria for VTEs requiring permanent discontinuation after one VTE instead of two. - Added discontinuation criteria to reflect the possibility of study termination following potential approval or dismissal of Baricitinib for atopic dermatitis within a given country. - Removed leukotriene inhibitors and allergen immunotherapy from prohibited medications.

Were there any global interruptions to the trial? No

Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data.

None reported

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Clinical trials

Clinical Trial Results: A Phase 3 Multicenter, Double-Blind Study to Evaluate the Long-Term Safety and Efficacy of Baricitinib in Adult Patients with Atopic Dermatitis

Trial information

Trial information

Subject disposition

Subject disposition

Baseline characteristics

Baseline characteristics

End points

End points

Primary: Responder and Partial Responders (RPR): Number of Participants From Monotherapy Studies (JAHL, JAHM) Who Achieved a Response of Investigator's Global Assessment (IGA) 0 or 1

Primary: Responder and Partial Responders (RPR): Number of Participants From Monotherapy Studies (JAHL, JAHM) Who Achieved a Response of Investigator's Global Assessment (IGA) 0 or 1

Primary: RPR: Number of Participants From Combination Therapy Study (JAIY) Who Achieved a Response of IGA 0 or 1

Primary: RPR: Number of Participants From Combination Therapy Study (JAIY) Who Achieved a Response of IGA 0 or 1

Secondary: RPR: Number of Participants From Monotherapy Studies (JAHL, JAHM) Who Achieved a Response of IGA 0, 1 or 2

Secondary: RPR: Number of Participants From Monotherapy Studies (JAHL, JAHM) Who Achieved a Response of IGA 0, 1 or 2

Secondary: RPR: Number of Participants From Combination Therapy Study (JAIY) Who Achieved a Response of IGA 0, 1, or 2

Secondary: RPR: Number of Participants From Combination Therapy Study (JAIY) Who Achieved a Response of IGA 0, 1, or 2

Secondary: Non Responders (NR): Number of Baricitinib NR Participants From Monotherapy Studies (JAHL, JAHM) Who Achieved a Response of IGA 0, 1 or 2

Secondary: Non Responders (NR): Number of Baricitinib NR Participants From Monotherapy Studies (JAHL, JAHM) Who Achieved a Response of IGA 0, 1 or 2

Secondary: NR: Number of Baricitinib NR Participants From Combination Therapy Study (JAIY) Who Achieved a Response of IGA 0, 1 or 2

Secondary: NR: Number of Baricitinib NR Participants From Combination Therapy Study (JAIY) Who Achieved a Response of IGA 0, 1 or 2

Secondary: NR: Number of Baricitinib NR Participants From Monotherapy Studies (JAHL, JAHM) Who Achieved a Response of IGA 0 or 1

Secondary: NR: Number of Baricitinib NR Participants From Monotherapy Studies (JAHL, JAHM) Who Achieved a Response of IGA 0 or 1

Secondary: NR: Number of Baricitinib NR Participants From Combination Therapy Study (JAIY) Who Achieved a Response of IGA 0 or 1

Secondary: NR: Number of Baricitinib NR Participants From Combination Therapy Study (JAIY) Who Achieved a Response of IGA 0 or 1

Secondary: RPR: Number of Participants From Monotherapy Studies (JAHL, JAHM) Who Achieved a Response of Eczema Area and Severity Index (EASI)75

Secondary: RPR: Number of Participants From Monotherapy Studies (JAHL, JAHM) Who Achieved a Response of Eczema Area and Severity Index (EASI)75

Secondary: RPR: Number of Participants From Combination Therapy Study (JAIY) Who Achieved a Response of EASI 75

Secondary: RPR: Number of Participants From Combination Therapy Study (JAIY) Who Achieved a Response of EASI 75

Secondary: NR: Number of Baricitinib NR Participants From Monotherapy Studies (JAHL, JAHM) Who Achieved a Response of EASI 75

Secondary: NR: Number of Baricitinib NR Participants From Monotherapy Studies (JAHL, JAHM) Who Achieved a Response of EASI 75

Secondary: NR: Number of Baricitinib NR Participants From Combination Therapy Study (JAIY) Who Achieved a Response of EASI 75

Secondary: NR: Number of Baricitinib NR Participants From Combination Therapy Study (JAIY) Who Achieved a Response of EASI 75

Secondary: RPR: Number of Participants From Monotherapy Studies (JAHL, JAHM) Who Achieved 4-Point Improvement Itch Numeric Rating Scale (NRS)

Secondary: RPR: Number of Participants From Monotherapy Studies (JAHL, JAHM) Who Achieved 4-Point Improvement Itch Numeric Rating Scale (NRS)

Secondary: RPR: Number of Participants From Combination Therapy Study (JAIY) Who Achieved 4-Point Improvement in Itch NRS

Secondary: RPR: Number of Participants From Combination Therapy Study (JAIY) Who Achieved 4-Point Improvement in Itch NRS

Secondary: NR: Number of Baricitinib NR Participants From Monotherapy Studies (JAHL, JAHM) Who Achieved 4-Point Improvement in Itch NRS

Secondary: NR: Number of Baricitinib NR Participants From Monotherapy Studies (JAHL, JAHM) Who Achieved 4-Point Improvement in Itch NRS

Secondary: NR: Number of Baricitinib NR Participants From Combination Therapy Study (JAIY) Who Achieved 4-Point Improvement in Itch NRS

Secondary: NR: Number of Baricitinib NR Participants From Combination Therapy Study (JAIY) Who Achieved 4-Point Improvement in Itch NRS

Secondary: NR: Number of Placebo NR Participants From Monotherapy Studies (JAHL, JAHM) Who Achieved a Response of IGA 0, 1 or 2

Secondary: NR: Number of Placebo NR Participants From Monotherapy Studies (JAHL, JAHM) Who Achieved a Response of IGA 0, 1 or 2

Secondary: NR: Number of Placebo NR Participants From Combination Therapy Study (JAIY) Who Achieved a Response of IGA 0, 1 or 2

Secondary: NR: Number of Placebo NR Participants From Combination Therapy Study (JAIY) Who Achieved a Response of IGA 0, 1 or 2

Secondary: NR: Number of Placebo NR Participants From Monotherapy Studies (JAHL, JAHM) Who Achieved a Response of IGA 0 or 1

Secondary: NR: Number of Placebo NR Participants From Monotherapy Studies (JAHL, JAHM) Who Achieved a Response of IGA 0 or 1

Secondary: NR: Number of Placebo NR Participants From Combination Therapy Study (JAIY) Who Achieved a Response of IGA 0 or 1

Secondary: NR: Number of Placebo NR Participants From Combination Therapy Study (JAIY) Who Achieved a Response of IGA 0 or 1

Secondary: NR: Number of Placebo NR Participants From Monotherapy Studies (JAHL, JAHM) Who Achieved a Response of EASI 75

Secondary: NR: Number of Placebo NR Participants From Monotherapy Studies (JAHL, JAHM) Who Achieved a Response of EASI 75

Secondary: NR: Number of Placebo NR Participants From Combination Therapy Study (JAIY) Who Achieved a Response of EASI 75

Secondary: NR: Number of Placebo NR Participants From Combination Therapy Study (JAIY) Who Achieved a Response of EASI 75

Secondary: NR: Number of Placebo NR Participants From Monotherapy Studies (JAHL, JAHM) Who Achieved 4-Point Improvement in Itch NRS

Secondary: NR: Number of Placebo NR Participants From Monotherapy Studies (JAHL, JAHM) Who Achieved 4-Point Improvement in Itch NRS

Secondary: NR: Number of Placebo NR Participants From Combination Therapy Study (JAIY) Who Achieved 4-Point Improvement in Itch NRS

Secondary: NR: Number of Placebo NR Participants From Combination Therapy Study (JAIY) Who Achieved 4-Point Improvement in Itch NRS

Adverse events

Adverse events

More information

Substantial protocol amendments (globally)

Interruptions (globally)

Limitations and caveats

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Clinical Trial Results:
A Phase 3 Multicenter, Double-Blind Study to Evaluate the Long-Term Safety and Efficacy of Baricitinib in Adult Patients with Atopic Dermatitis