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Clinical Trial Results:
A Phase IIb, Multi-Center, Long-Term Extension Trial to Evaluate the Safety and Tolerability of Atacicept in Subjects with Systemic Lupus Erythematosus (SLE) who Completed Protocol EMR-700461-023 (ADDRESS II)

Summary
EudraCT number	2013-002758-62
Trial protocol	DE IT BG CZ GB ES
Global end of trial date	09 Feb 2018

Results information
Results version number	v2(current)
This version publication date	12 Apr 2019
First version publication date	24 Feb 2019
Other versions	v1
Version creation reason

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

700461-024

ISRCTN number

US NCT number

NCT02070978

WHO universal trial number (UTN)

Sponsor organisation name

Merck KGaA

Sponsor organisation address

Frankfurter Strasse 250, Darmstadt, Germany, 64293

Public contact

Communication Centre Merck KGaA, Merck KGaA, +49 615172 5200, service@merckgroup.com

Scientific contact

Communication Center Merck KGaA, Merck KGaA, +49 6151725200, service@merckgroup.com

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

Final

Date of interim/final analysis

09 Feb 2018

Is this the analysis of the primary completion data?

Global end of trial reached?

Yes

Global end of trial date

09 Feb 2018

Was the trial ended prematurely?

Yes

Main objective of the trial

This is a multicenter, double-blind, Phase 2b, long-term extension (LTE) to the ADDRESS II core trial (EMR 700461-023) (NCT01972568), to evaluate long-term safety and tolerability of atacicept in subjects with systemic lupus erythematosus (SLE).

Protection of trial subjects

Subject protection was ensured by following high medical and ethical standards in accordance with the principles laid down in the Declaration of Helsinki, and that are consistent with Good Clinical Practice and applicable regulations.

Background therapy

Evidence for comparator

Actual start date of recruitment

29 Jul 2014

Long term follow-up planned

Independent data monitoring committee (IDMC) involvement?

Yes

Number of subjects enrolled per country

Country: Number of subjects enrolled

South Africa: 11

Country: Number of subjects enrolled

Spain: 3

Country: Number of subjects enrolled

United Kingdom: 3

Country: Number of subjects enrolled

United States: 45

Country: Number of subjects enrolled

Argentina: 45

Country: Number of subjects enrolled

Brazil: 2

Country: Number of subjects enrolled

Bulgaria: 26

Country: Number of subjects enrolled

Chile: 18

Country: Number of subjects enrolled

Czech Republic: 5

Country: Number of subjects enrolled

Germany: 2

Country: Number of subjects enrolled

Italy: 1

Country: Number of subjects enrolled

Korea, Republic of: 4

Country: Number of subjects enrolled

Mexico: 48

Country: Number of subjects enrolled

Peru: 6

Country: Number of subjects enrolled

Philippines: 20

Country: Number of subjects enrolled

Poland: 1

Country: Number of subjects enrolled

Russian Federation: 13

Worldwide total number of subjects

253

EEA total number of subjects

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)

248

From 65 to 84 years

85 years and over

Subject disposition

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Recruitment details

Subjects who completed 24-week of the ADDRESS II core study (NCT01972568) and didn't meet any discontinuation criteria were enrolled in this long-term extension (LTE) study NCT02070978. The study was conducted at 81 sites in 17 countries in Asia, Europe, North America, Central America, and South America.

Screening details

Subjects who received placebo in core study ADDRESS II were switched to receive atacicept 150 milligram (mg) as once-weekly subcutaneous injections in LTE study. Subjects who received atacicept 75 mg or 150 mg in core study ADDRESS II continued to receive the respective randomized dosage as once-weekly subcutaneous injections in LTE study.

Period 1 title

Overall Study (overall period)

Is this the baseline period?

Yes

Allocation method

Non-randomised - controlled

Blinding used

Double blind

Roles blinded

Subject, Investigator

Are arms mutually exclusive

Yes

Placebo/Atacicept 150 mg

Arm description

Subjects received atacicept 150 mg as once-weekly subcutaneous injection during this LTE study up to a maximum of 97.7 weeks.

Arm type

Experimental

Investigational medicinal product name

Atacicept

Investigational medicinal product code

Other name

Pharmaceutical forms

Solution for injection

Routes of administration

Subcutaneous use

Dosage and administration details

Subjects received atacicept 150 mg as once-weekly subcutaneous injection during this LTE study up to a maximum of 97.7 weeks.

Atacicept 75 mg

Arm description

Subjects received atacicept 75 mg as once-weekly subcutaneous injection during this LTE study up to a maximum of 143.7 weeks.

Arm type

Experimental

Investigational medicinal product name

Atacicept

Investigational medicinal product code

Other name

Pharmaceutical forms

Solution for injection

Routes of administration

Subcutaneous use

Dosage and administration details

Subjects received atacicept 75 mg as once-weekly subcutaneous injection during this LTE study up to a maximum of 143.7 weeks.

Atacicept 150 mg

Arm description

Subjects received atacicept 150 mg as once-weekly subcutaneous injection during this LTE study up to a maximum of 97.9 weeks.

Arm type

Experimental

Investigational medicinal product name

Atacicept

Investigational medicinal product code

Other name

Pharmaceutical forms

Solution for injection

Routes of administration

Subcutaneous use

Dosage and administration details

Subjects received atacicept 150 mg as once-weekly subcutaneous injection during this LTE study up to a maximum of 97.9 weeks.

Number of subjects in period 1	Placebo/Atacicept 150 mg	Atacicept 75 mg	Atacicept 150 mg
Started	83	82	88
Completed	36	29	35
Not completed	47	53	53
Terminated by Sponsor	33	40	39
Consent withdrawn by subject	3	5	3
Adverse Event	6	2	-
Death	-	-	2
Un-specified	3	2	2
Lost to follow-up	1	3	4
Protocol deviation	1	-	3
Lack of efficacy	-	1	-

Baseline characteristics

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Reporting group title

Placebo/Atacicept 150 mg

Reporting group description

Subjects received atacicept 150 mg as once-weekly subcutaneous injection during this LTE study up to a maximum of 97.7 weeks.

Reporting group title

Atacicept 75 mg

Reporting group description

Subjects received atacicept 75 mg as once-weekly subcutaneous injection during this LTE study up to a maximum of 143.7 weeks.

Reporting group title

Atacicept 150 mg

Reporting group description

Subjects received atacicept 150 mg as once-weekly subcutaneous injection during this LTE study up to a maximum of 97.9 weeks.

Reporting group values	Placebo/Atacicept 150 mg	Atacicept 75 mg	Atacicept 150 mg	Total
Number of subjects	83	82	88	253
Age categorical
Units: Subjects
Age Continuous
Units: Years
arithmetic mean (standard deviation)	41 ( 13.0 )	37 ( 10.7 )	38 ( 11.5 )	-
Sex: Female, Male
Units: Subjects
Female	74	75	82	231
Male	9	7	6	22
Race (NIH/OMB)
Units: Subjects
American Indian or Alaska Native	4	3	3	10
Asian	7	13	13	33
Native Hawaiian or Other Pacific Islander	1	0	0	1
Black or African American	3	3	7	13
White	64	58	55	177
More than one race	0	0	0	0
Unknown or Not Reported	4	5	10	19
Ethnicity (NIH/OMB)
Units: Subjects
Hispanic or Latino	48	43	40	131
Not Hispanic or Latino	35	39	48	122
Unknown or Not Reported	0	0	0	0

End points

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Reporting group title

Placebo/Atacicept 150 mg

Reporting group description

Subjects received atacicept 150 mg as once-weekly subcutaneous injection during this LTE study up to a maximum of 97.7 weeks.

Reporting group title

Atacicept 75 mg

Reporting group description

Subjects received atacicept 75 mg as once-weekly subcutaneous injection during this LTE study up to a maximum of 143.7 weeks.

Reporting group title

Atacicept 150 mg

Reporting group description

Subjects received atacicept 150 mg as once-weekly subcutaneous injection during this LTE study up to a maximum of 97.9 weeks.

Primary: Number of Subjects With at least one Serious Adverse Event (SAE) During the Treatment Period

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End point title

Number of Subjects With at least one Serious Adverse Event (SAE) During the Treatment Period ^[1]

End point description

Adverse event (AE) was defined as any unfavorable & unintended sign, symptom or disease associated use of study drug, whether or not considered related to study drug/worsening of pre-existing medical condition. Serious AE: resulted in any of following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect/was otherwise considered medically important. AE was considered as 'treatment emergent' if occurred after first drug of each period/if it was present prior to drug administration but exacerbated after drug administration. Treatment Emergent AEs during treatment period exclude those ongoing at time of study entry into 024 LTE Day 1 & exclude safety follow-up period. The safety analyses set included all participants enrolled into the LTE study and who received at least 1 dose of planned study treatment. Subjects were analyzed according to the actual treatment they received.

End point type

Primary

End point timeframe

Baseline (LTE Day 1) up to maximum treatment duration of 143.7 weeks

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: Only descriptive data was planned to be reported for this endpoint.

End point values	Placebo/Atacicept 150 mg	Atacicept 75 mg	Atacicept 150 mg
Number of subjects analysed	83	82	88
Units: Subjects	13	10	9

No statistical analyses for this end point

Primary: Number of Subjects who Prematurely Discontinued the Treatment due to Adverse Events (AEs)

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End point title

Number of Subjects who Prematurely Discontinued the Treatment due to Adverse Events (AEs) ^[2]

End point description

An Adverse event (AE) was defined as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease associated with the use of study drug, whether or not considered related to the study drug or worsening of pre-existing medical condition, whether or not related to study drug. TEAEs were defined as events with an onset date on or after the date of first dose of study treatment in the core study and ongoing at the 024 LTE study entry, occurring during the 024 LTE study and the Safety follow-up Period. The safety analyses set included all participants enrolled into the LTE study and who received at least 1 dose of planned study treatment. Subjects were analyzed according to the actual treatment they received.

End point type

Primary

End point timeframe

Baseline (Day 1 of Core study) up to maximum duration of 167.7 weeks

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: Only descriptive data was planned to be reported for this endpoint.

End point values	Placebo/Atacicept 150 mg	Atacicept 75 mg	Atacicept 150 mg
Number of subjects analysed	83	82	88
Units: Subjects	9	4	5

No statistical analyses for this end point

Secondary: Change from Baseline in Systemic Lupus International Collaborating Clinics/American College of Rheumatology (SLICC/ACR) Damage Index Organ Damage Scores

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End point title

Change from Baseline in Systemic Lupus International Collaborating Clinics/American College of Rheumatology (SLICC/ACR) Damage Index Organ Damage Scores

End point description

SLICC/ACR score or damage index evaluates cumulative damage in Systemic Lupus Erythematosus (SLE). These changes may or may not be related to SLE. Most items are scored only if they have been present for at least 6 months. Scores range from 0 to 47 points, with higher scores indicating greater cumulative damage. Baseline was defined as Day 1 of Core study. Modified intent-to-treat (mITT) analysis set was defined as all enrolled subjects in the LTE study. Efficacy analyses were performed on the mITT analysis set according to randomized treatment. Here "n" signifies those subjects who were evaluable for this endpoint at specified categories.

End point type

Secondary

End point timeframe

Baseline: Day 1 (Core Study), Day 1 (LTE Study), Week 24, Week 48, Week 72 and Week 96

End point values	Placebo/Atacicept 150 mg	Atacicept 75 mg	Atacicept 150 mg
Number of subjects analysed	83	82	88
Units: Units on a scale
arithmetic mean (standard deviation)
Baseline; Day 1 (Core Study) (n = 83, 82, 88)	1 ( 1.0 )	1 ( 1.2 )	0 ( 0.8 )
Change at LTE Day 1 (n = 83, 82, 88)	0 ( 0.0 )	0 ( 0.1 )	0 ( 0.0 )
Change at LTE Week 24 (n = 74, 75, 83)	0 ( 0.1 )	0 ( 0.1 )	0 ( 0.2 )
Change at LTE Week 48 (n = 61, 63, 70)	0 ( 0.2 )	0 ( 0.2 )	0 ( 0.3 )
Change at LTE Week 72 (n = 33, 30, 32)	0 ( 0.3 )	0 ( 0.3 )	0 ( 0.2 )
Change at LTE Week 96 (n = 9, 14, 13)	0 ( 0.3 )	0 ( 0.3 )	0 ( 0.0 )

No statistical analyses for this end point

Secondary: Change from Baseline in Disease Activity as Measured by British Isles Lupus Assessment Group (BILAG) 2004 Score

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End point title

Change from Baseline in Disease Activity as Measured by British Isles Lupus Assessment Group (BILAG) 2004 Score

End point description

BILAG Disease Activity Index evaluates systemic lupus erythematosus (SLE) activity in 8 organ system domains: General, mucocutaneous, neurological, musculoskeletal, cardiorespiratory, vasculitis, renal, and hematologic using a separate alphabetic score (A to E) assigned to each organ system defined as follows. BILAG A: Severe disease activity; BILAG B: moderate disease activity; BILAG C: mild disease; BILAG D: system previously affected but now inactive; BILAG E: system never involved. BILAG evaluated by scoring each of a list of signs and symptoms as: improving (1); same (2); worse (3); new (4); not present (0); not done (ND). The total BILAG score is the sum of the scores of the 8 domains where A=9, B=3, C=1, D=0, and E=0. The total score ranges from 0 to 72 with a higher score indicating greater lupus activity. mITT analysis set used. Here "n" signifies those subjects who were evaluable for this outcome measure at specified categories.

End point type

Secondary

End point timeframe

Baseline: Core study Screening, LTE Day 1, Week 24, Week 48, Week 72 and Week 96

End point values	Placebo/Atacicept 150 mg	Atacicept 75 mg	Atacicept 150 mg
Number of subjects analysed	83	82	88
Units: Units on a scale
arithmetic mean (standard deviation)
Baseline: Core study Screening (n= 83, 82, 88)	15 ( 7.1 )	14 ( 7.2 )	16 ( 6.1 )
Change at LTE Day 1 (n= 83, 82, 88)	-8 ( 6.9 )	-9 ( 7.2 )	-10 ( 6.8 )
Change at LTE Week 24 (n= 74, 75, 83)	-8 ( 8.3 )	-10 ( 7.5 )	-12 ( 7.2 )
Change at LTE Week 48 (n= 61, 63, 70)	-9 ( 7.7 )	-8 ( 7.5 )	-11 ( 7.4 )
Change at LTE Week 72 (n= 33, 30, 32)	-9 ( 7.9 )	-10 ( 6.2 )	-11 ( 8.2 )
Change at LTE Week 96 (n= 9, 14, 13)	-14 ( 12.9 )	-8 ( 6.3 )	-12 ( 6.8 )

No statistical analyses for this end point

Secondary: Change from Baseline in Disease Activity as Measured by Systemic Lupus Erythematosus Disease Activity Index-2000 (SLEDAI-2K) Score

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End point title

Change from Baseline in Disease Activity as Measured by Systemic Lupus Erythematosus Disease Activity Index-2000 (SLEDAI-2K) Score

End point description

SLEDAI-2K is an activity index that measures disease activity and records feature of active lupus as present or not present. SLEDAI-2K uses a weighted checklist to assign a numerical score based on the presence or absence of 24 symptoms. Each symptom present is assigned between 1 and 8 points based on its usual clinical importance, yielding a total score that ranges from 0 points (no symptoms) to 105 points (presence of all defined symptoms). Baseline was defined as core study screening visit. mITT analysis set was defined as all enrolled subjects in the LTE study. Efficacy analyses were performed on the mITT analysis set according to randomized treatment. Here, "n" signifies those subjects who were evaluable for this outcome measure at specified categories.

End point type

Secondary

End point timeframe

Baseline: Screening Visit (Core Study); LTE Day 1, Week 24, Week 48, Week 72 and Week 96

End point values	Placebo/Atacicept 150 mg	Atacicept 75 mg	Atacicept 150 mg
Number of subjects analysed	83	82	88
Units: Units on a scale
arithmetic mean (standard deviation)
Screening Visit (Core Study) (n = 83, 82, 88)	10 ( 2.9 )	10 ( 3.4 )	10 ( 3.0 )
Change at LTE Day 1 (n = 83, 82, 88)	-4 ( 4.1 )	-5 ( 4.5 )	-5 ( 3.9 )
Change at LTE Week 24 (n = 74, 75, 83)	-5 ( 4.3 )	-6 ( 4.1 )	-6 ( 3.9 )
Change at LTE Week 48 (n = 61, 63, 70)	-6 ( 3.4 )	-6 ( 4.6 )	-7 ( 4.3 )
Change at LTE Week 72 (n = 33, 30, 32)	-5 ( 3.8 )	-6 ( 3.7 )	-7 ( 3.9 )
Change at LTE Week 96 (n = 9, 14, 13)	-7 ( 5.0 )	-6 ( 4.9 )	-8 ( 2.7 )

No statistical analyses for this end point

Secondary: Change from Baseline in Disease Activity as Measured by SLEDAI-2K Responder Index-50 (SRI-50) Score

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End point title

Change from Baseline in Disease Activity as Measured by SLEDAI-2K Responder Index-50 (SRI-50) Score

End point description

SRI-50 index was derived from SLEDAI-2K & capture 50% or better improvement in each descriptor between any 2 visits in systemic lupus erythematosus (SLE) participants when there was incomplete resolution. New assigned scores for descriptors of SRI-50 were derived by dividing score of each SLEDAI-2K descriptor by 2. SLEDAI-2K was an activity index that measured disease activity & records feature of active lupus as present/not present. SLEDAI-2K used weighted checklist to assign numerical score based on presence/ absence of 24 symptoms. Each symptom was assigned between 1 & 8 points based on its usual clinical importance, yielding a total score that ranged from 0(no symptoms) to 105 points(presence of all defined symptoms). Data was not collected for this endpoint as results from ADDRESSII core study(NCT01972568) for SRI-50 were not significant. Therefore, data collection for SRI-50 for current study (700461-024; NCT02070978) was halted & no analysis was conducted for endpoint.

End point type

Secondary

End point timeframe

Baseline: Screening Visit (Core Study); LTE Day 1, Week 24, Week 48, Week 72 and Week 96

End point values	Placebo/Atacicept 150 mg	Atacicept 75 mg	Atacicept 150 mg
Number of subjects analysed	0 ^[3]	0 ^[4]	0 ^[5]
Units: Units on a scale
arithmetic mean (standard deviation)	( )	( )	( )

Notes
[3] - Data was not collected for this endpoint as results from core study for SRI-50 were not significant.
[4] - Data was not collected for this endpoint as results from core study for SRI-50 were not significant.
[5] - Data was not collected for this endpoint as results from core study for SRI-50 were not significant.

No statistical analyses for this end point

Secondary: Change from Baseline in Disease Activity as Measured by Physician's Global Assessment (PGA) Score

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End point title

Change from Baseline in Disease Activity as Measured by Physician's Global Assessment (PGA) Score

End point description

The PGA was used to quantify disease activity and was measured using an anchored visual analog scale (VAS). The subject’s current disease activity assessed by investigator in the score range of 0 to 3. Where 0=none; 1=mild; 2=moderate; 3=severe. The assessment made relative not to the subject’s most severe state, but the most severe state of systemic lupus erythematosus (SLE) per the investigator’s assessment. Baseline was defined as core study screening visit. mITT analysis set was defined as all enrolled subjects in the LTE study. Efficacy analyses were performed on the mITT analysis set according to randomized treatment. Here "n" signifies those subjects who were evaluable for this endpoint at specified categories.

End point type

Secondary

End point timeframe

Baseline: Screening Visit (Core Study); LTE Day1, Week 24, Week 48, Week 72 and Week 96

End point values	Placebo/Atacicept 150 mg	Atacicept 75 mg	Atacicept 150 mg
Number of subjects analysed	83	82	88
Units: Units on a scale
arithmetic mean (standard deviation)
Baseline: Screening Visit(Core Study) (n=83,82,88)	1.56 ( 0.424 )	1.46 ( 0.509 )	1.47 ( 0.460 )
Change at LTE Day 1 (n = 83, 82, 88)	-0.76 ( 0.559 )	-0.77 ( 0.559 )	-0.77 ( 0.614 )
Change at LTE Week 24 (n = 74, 75, 83)	-0.91 ( 0.620 )	-0.85 ( 0.555 )	-0.94 ( 0.547 )
Change at LTE Week 48 (n = 61, 63, 70)	-1.01 ( 0.647 )	-0.86 ( 0.522 )	-0.99 ( 0.557 )
Change at LTE Week 72 (n = 33, 30, 32)	-0.90 ( 0.758 )	-0.84 ( 0.503 )	-1.03 ( 0.580 )
Change at LTE Week 96 (n = 9, 14, 13)	-1.17 ( 0.518 )	-0.72 ( 0.579 )	-1.21 ( 0.411 )

No statistical analyses for this end point

Secondary: Number of Subjects who Achieved SLE Responder Index (SRI-4) Response (a Disease Activity Composite Index)

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End point title

Number of Subjects who Achieved SLE Responder Index (SRI-4) Response (a Disease Activity Composite Index)

End point description

SRI-4 response defined as >= to 4-point reduction in Systemic Lupus Erythematosus Disease Activity Index 2000 (SLEDAI-2K) total score, no new British Isles Lupus Assessment Group (BILAG) A & no more than 1 new BILAG B domain score & no worsening (< 10 % increase) from baseline Physician’s Global Assessment of Disease Activity (PGA). SLEDAI-2K is an activity index that measures disease activity & records feature of active lupus as present or not present. SLEDAI-2K uses a weighted checklist to assign a numerical score based on presence or absence of 24 symptoms. Each symptom present assigned between 1 & 8 points based on its usual clinical importance, yielding a total score that ranges from 0 points (no symptoms) to 105 points (presence of all defined symptoms). mITT analysis set was used. Here baseline measured as reference timepoint for response in screening visit from core study. Here "n" signifies those subjects who were evaluable for this outcome measure at specified categories.

End point type

Secondary

End point timeframe

Baseline: Core study Screening; LTE Day 1, Week 24, Week 48, Week 72 and Week 96

End point values	Placebo/Atacicept 150 mg	Atacicept 75 mg	Atacicept 150 mg
Number of subjects analysed	83	82	88
Units: Subjects
LTE Day 1 (n= 83, 82, 88)	42	52	57
LTE Week 24 (n= 74, 75, 83)	43	57	60
LTE Week 48 (n= 61, 63, 70)	44	46	51
LTE Week 72 (n= 33, 30, 32)	21	23	23
LTE Week 96 (n= 9, 14, 13)	6	9	12

No statistical analyses for this end point

Secondary: Number of Subjects who Achieved BILAG-based Combined Lupus Assessment (BICLA) Response (a Disease Activity Composite Index)

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End point title

Number of Subjects who Achieved BILAG-based Combined Lupus Assessment (BICLA) Response (a Disease Activity Composite Index)

End point description

The BICLA response was defined as BILAG-2004 improvement (all screening visit BILAG A improving to B/C/D, all screening visit BILAG B to C/D, and less than or equal to (<=1) new BILAG B and no new BILAG A); no deterioration in SLEDAI total score; PGA increase by less than (<) 0 percentage (%) (defined as less then (<)0.3 point increase for the statistical analyses) and no non-permitted medication/treatment. mITT BILAG analysis set included mITT population with at least one BILAG A and/or B at screening visit. Here "n" signifies those subjects who were evaluable for this outcome measure at specified categories.

End point type

Secondary

End point timeframe

Baseline: Core study Screening; LTE Day 1, Week 24, Week 48, Week 72 and Week 96

End point values	Placebo/Atacicept 150 mg	Atacicept 75 mg	Atacicept 150 mg
Number of subjects analysed	76	70	86
Units: Subjects
LTE Day 1 (n= 76, 70, 86)	43	43	50
LTE Week 24 (n= 67, 66, 81)	40	45	53
LTE Week 48 (n= 55, 55, 68)	35	34	43
LTE Week 72 (n= 29, 27, 30)	16	17	21
LTE Week 96 (n= 8, 12, 12)	4	7	9

No statistical analyses for this end point

Secondary: Percent Change from Baseline in Prednisone-equivalent Corticosteroid Dose

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End point title

Percent Change from Baseline in Prednisone-equivalent Corticosteroid Dose

End point description

mITT analysis set was defined as all enrolled subjects in the LTE study. Efficacy analyses were performed on the mITT analysis set according to randomized treatment. Here "n" signifies those subjects who were evaluable for this endpoint at specified categories.

End point type

Secondary

End point timeframe

Baseline: Screening Visit (Core Study); LTE Day 1, Week 24, Week 48, Week 72 and Week 96

End point values	Placebo/Atacicept 150 mg	Atacicept 75 mg	Atacicept 150 mg
Number of subjects analysed	83	82	88
Units: Percent change
arithmetic mean (standard deviation)
Percent Change at LTE Day 1 (n = 83, 82, 87)	-11.04 ( 31.139 )	-5.25 ( 55.697 )	-11.54 ( 26.117 )
Percent Change at LTE Week 24 (n = 73, 74, 83)	-11.89 ( 41.411 )	-4.79 ( 59.371 )	-1.21 ( 94.677 )
Percent Change at LTE Week 48 (n = 61, 62, 69)	-9.19 ( 54.364 )	-6.01 ( 45.605 )	-17.97 ( 37.040 )
Percent Change at LTE Week 72 (n = 33, 30, 32)	-19.32 ( 38.157 )	-8.69 ( 28.112 )	-22.34 ( 36.058 )
Percent Change at LTE Week 96 (n = 15, 17, 14)	-36.67 ( 58.146 )	-12.40 ( 73.793 )	-28.57 ( 43.080 )

No statistical analyses for this end point

Secondary: Change From Baseline in the Short-Form (SF-36) Health Survey Physical Component Score and Mental Component Score

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End point title

Change From Baseline in the Short-Form (SF-36) Health Survey Physical Component Score and Mental Component Score

End point description

The 36-Item Short-Form Health Survey (SF-36) is a standardized survey evaluating 8 aspects of functional health and well-being. These eight subscales were summarized as relating to either physical health or mental health. Physical component summary (PCS) is based primarily on physical functioning, role-physical, bodily pain, and general health scales and mental component summary (MCS) encompasses vitality, social functioning, role-emotional, and mental health scales. Score from mental health, role emotional, social functioning, and vitality domains were averaged to calculate MCS. Total score range for MCS was 0-100 (100=highest level of mental functioning). Score from physical function, role physical, bodily pain, and general health domains were averaged to calculate PCS. Total score range for PCS was 0-100 (100=highest level of physical functioning). mITT analysis set was used. Here "n" signifies those subjects who were evaluable for this outcome measure at specified categories.

End point type

Secondary

End point timeframe

Baseline (Core Study Day 1); LTE Day 1, Week 24, Week 48, Week 72 and Week 96

End point values	Placebo/Atacicept 150 mg	Atacicept 75 mg	Atacicept 150 mg
Number of subjects analysed	83	82	88
Units: Units on a scale
arithmetic mean (standard deviation)
PCS: Baseline: Core Study Day 1 (n= 81, 81, 85)	37.7 ( 9.20 )	37.8 ( 10.56 )	38.8 ( 9.27 )
PCS: Change at LTE Day 1 (n= 81, 81, 85)	4.8 ( 10.00 )	4.8 ( 8.30 )	4.0 ( 7.46 )
PCS: Change at LTE Week 24 (n= 72, 74, 80)	5.3 ( 8.62 )	5.1 ( 8.78 )	5.9 ( 7.74 )
PCS: Change at LTE Week 48 (n= 59, 61, 66)	6.4 ( 9.56 )	6.2 ( 9.67 )	4.6 ( 8.23 )
PCS: Change at LTE Week 72 (n= 29, 30, 29)	5.8 ( 8.61 )	3.4 ( 7.37 )	6.7 ( 5.33 )
PCS: Change at LTE Week 96 (n= 8, 14, 13)	13.0 ( 9.51 )	3.1 ( 9.29 )	8.9 ( 6.08 )
MCS: Baseline: Core Study Day 1 (n= 81, 81, 85)	41.3 ( 10.70 )	43.3 ( 12.09 )	43.2 ( 10.81 )
MCS: Change at LTE Day 1 (n= 81, 81, 85)	2.1 ( 11.38 )	2.2 ( 12.62 )	1.9 ( 9.30 )
MCS: Change at LTE Week 24 (n= 72, 74, 80)	4.4 ( 10.43 )	3.0 ( 11.75 )	2.0 ( 10.26 )
MCS: Change at LTE Week 48 (n= 59, 61, 66)	3.3 ( 11.72 )	2.8 ( 13.19 )	3.5 ( 11.39 )
MCS Change at LTE Week 72 (n= 29, 30, 29)	3.8 ( 10.96 )	1.1 ( 11.74 )	1.5 ( 13.64 )
MCS: Change at LTE Week 96 (n= 8, 14, 13)	10.3 ( 15.86 )	0.6 ( 9.03 )	3.2 ( 12.20 )

No statistical analyses for this end point

Secondary: Change from Baseline in Lupus Quality of Life (LupusQoL) Questionnaire Score

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End point title

Change from Baseline in Lupus Quality of Life (LupusQoL) Questionnaire Score

End point description

The LupusQoL was a lupus-specific health related QoL (HRQoL) questionnaire consisting of 34 items grouped in 8 domains: physical health (PH), pain, planning, intimate relationships (IR), burden to others (BtO), emotional health (EH), body image (BI), and fatigue. Subjects indicate their responses on a 5-point Likert response format, where 4 = never, 3 = occasionally, 2 = a good bit of the time, 1 = most of the time, and 0 = all of the time. Summary scores can be calculated for all 8 domains. A LupusQoL score for each domain was reported on a 0 to 100 scale, with greater values indicating better HRQoL. Baseline was defined as Day 1 of core study. mITT analysis set was defined as all enrolled subjects in the LTE study. Efficacy analyses were performed on the mITT analysis set according to randomized treatment. Here "n" signifies those subjects who were evaluable for this endpoint at specified categories.

End point type

Secondary

End point timeframe

Baseline (Core Study Day 1); LTE Day 1, Week 24, Week 48, Week 72, and Week 96

End point values	Placebo/Atacicept 150 mg	Atacicept 75 mg	Atacicept 150 mg
Number of subjects analysed	83	82	88
Units: Units on a scale
arithmetic mean (standard deviation)
PH: Baseline: Core study Day 1 (n=81, 82, 86)	60.2 ( 23.08 )	62.0 ( 27.17 )	61.3 ( 27.87 )
PH: Change at LTE Day 1 (n = 81, 81, 86)	8.8 ( 21.86 )	7.5 ( 17.37 )	8.2 ( 16.40 )
PH: Change at LTE week 24 (n = 72, 75, 81)	10.4 ( 21.27 )	10.8 ( 18.86 )	10.9 ( 18.46 )
PH: Change at LTE week 48 (n = 58, 62, 67)	9.3 ( 22.23 )	11.2 ( 24.80 )	12.8 ( 20.30 )
PH: Change at LTE week 72 (n = 29, 30, 29)	8.0 ( 19.42 )	5.9 ( 17.61 )	11.9 ( 20.02 )
PH: Change at week 96 (n = 8, 14, 13)	25.0 ( 21.46 )	12.9 ( 17.97 )	14.4 ( 10.33 )
Pain: Baseline: Core study Day 1 (n = 81, 82, 86)	58.7 ( 26.77 )	61.2 ( 30.27 )	57.7 ( 31.52 )
Pain: Change at LTE Day 1 (n = 81, 81, 86)	11.8 ( 24.86 )	11.0 ( 23.93 )	13.4 ( 21.78 )
Pain: Change at LTE week 24 (n = 72, 75, 81)	14.4 ( 26.21 )	11.9 ( 23.38 )	16.4 ( 24.10 )
Pain: Change at LTE week 48 (n = 58, 62, 67)	12.8 ( 27.76 )	14.0 ( 29.64 )	17.3 ( 24.67 )
Pain: Change at LTE week 72 (n = 29, 30, 29)	16.7 ( 26.73 )	10.3 ( 18.91 )	17.2 ( 26.63 )
Pain: Change at LTE Week 96 (n = 8, 14, 13)	41.7 ( 30.21 )	11.9 ( 23.73 )	17.9 ( 23.78 )
Planning: Baseline: Core study Day 1(n=81, 82, 86)	65.6 ( 27.52 )	68.3 ( 30.81 )	64.6 ( 33.26 )
Planning: Change at LTE Day 1 (n = 81, 81, 86)	8.4 ( 25.60 )	1.5 ( 22.79 )	7.5 ( 23.08 )
Planning: Change at LTE Week 24 (n = 72, 75, 81)	11.2 ( 27.34 )	7.0 ( 24.16 )	8.4 ( 25.29 )
Planning: Change at LTE Week 48 (n = 58, 62, 67)	14.5 ( 29.27 )	6.5 ( 26.88 )	10.9 ( 26.16 )
Planning: Change at LTE Week 72 (n = 29, 30, 29)	10.3 ( 22.23 )	0.0 ( 28.37 )	15.5 ( 30.52 )
Planning: Change at LTE Week 96 (n = 8, 14, 13)	19.8 ( 36.98 )	3.0 ( 24.59 )	21.8 ( 26.03 )
IR: Baseline: Core study Day 1 (n = 67, 74, 66)	67.2 ( 30.99 )	60.6 ( 34.17 )	62.1 ( 31.62 )
IR: Change at LTE Day 1(n= 57, 64, 55)	3.9 ( 26.95 )	0.2 ( 27.77 )	-1.6 ( 23.94 )
IR: Change at LTE Week 24 (n= 48, 60, 52)	3.6 ( 26.29 )	7.1 ( 24.50 )	6.3 ( 25.67 )
IR: Change at LTE Week 48 (n= 38, 48, 43)	2.3 ( 29.19 )	5.7 ( 33.02 )	8.4 ( 30.58 )
IR: Change at LTE Week 72 (n= 18, 27, 24)	-6.3 ( 20.67 )	-2.8 ( 29.89 )	5.2 ( 32.95 )
IR: Change at LTE Week 96 (n= 5, 13, 7)	12.5 ( 15.31 )	2.9 ( 16.26 )	-14.3 ( 39.81 )
BtO: Baseline: Core study Day 1 (n = 81, 82, 86)	49.0 ( 31.22 )	48.5 ( 32.34 )	47.3 ( 32.97 )
BtO: Change at LTE Day 1 (n = 81, 81, 86)	13.4 ( 26.31 )	14.7 ( 25.83 )	12.5 ( 25.36 )
BtO: Change at LTE Week 24 (n= 72, 75, 81)	13.1 ( 26.08 )	16.8 ( 27.35 )	15.7 ( 27.73 )
BtO: Change at LTE Week 48 (n = 58, 62, 67)	13.4 ( 25.69 )	18.3 ( 30.36 )	17.9 ( 28.73 )
BtO: Change at LTE Week 72 (n= 29, 30, 29)	12.1 ( 21.89 )	14.4 ( 32.23 )	22.1 ( 31.68 )
BtO: Change at LTE Week 96 (n= 8, 14, 13)	17.7 ( 32.56 )	20.2 ( 33.29 )	30.1 ( 37.51 )
EH: Baseline: Core study Day 1 (n = 81, 82, 86)	64.1 ( 23.43 )	68.3 ( 25.86 )	67.6 ( 27.10 )
EH: Change at LTE Day 1 (n = 81, 81, 86)	7.9 ( 19.73 )	6.0 ( 20.08 )	7.0 ( 21.21 )
EH: Change at LTE Week 24 (n = 72, 75, 81)	11.2 ( 20.67 )	6.7 ( 21.87 )	7.9 ( 20.68 )
EH: Change at LTE Week 48 (n = 58, 62, 67)	14.2 ( 21.91 )	9.3 ( 25.66 )	8.0 ( 21.73 )
EH: Change at LTE Week 72 (n = 29, 30, 29)	10.1 ( 20.49 )	3.2 ( 17.50 )	11.5 ( 26.30 )
EH: Change at LTE Week 96 (n = 8, 14, 13)	22.4 ( 26.16 )	6.8 ( 12.40 )	16.3 ( 22.08 )
BI: Baseline: Core study Day 1 (n = 76, 71, 82)	63.8 ( 27.82 )	61.9 ( 31.45 )	64.4 ( 30.51 )
BI: Change at LTE Day 1 (n = 61, 67, 72)	12.9 ( 24.47 )	6.2 ( 20.69 )	4.7 ( 25.29 )
BI: Change at LTE Week 24 (n = 59, 60, 64)	13.2 ( 25.94 )	9.1 ( 22.33 )	4.5 ( 29.34 )
BI: Change at LTE Week 48 (n = 45, 54, 55)	11.6 ( 25.39 )	14.9 ( 25.10 )	7.5 ( 28.45 )
BI: Change at LTE Week 72 (n = 22, 28, 22)	11.0 ( 19.15 )	8.5 ( 16.34 )	13.8 ( 29.79 )
BI: Change at LTE Week 96 (n = 8, 13, 10)	27.1 ( 32.79 )	13.4 ( 21.87 )	10.5 ( 38.19 )
Fatigue: Baseline: Core study Day 1 (n=81, 82, 86)	53.4 ( 26.83 )	55.6 ( 27.82 )	56.8 ( 29.00 )
Fatigue: Change at LTE Day 1 (n = 81, 81, 86)	9.3 ( 21.47 )	5.9 ( 21.05 )	7.0 ( 20.93 )
Fatigue: Change at LTE Week 24 (n = 72, 75, 81)	10.6 ( 23.77 )	7.1 ( 20.89 )	8.2 ( 21.96 )
Fatigue: Change at LTE Week 48 (n = 58, 62, 67)	7.1 ( 23.28 )	11.9 ( 22.05 )	10.8 ( 20.05 )
Fatigue: Change at LTE Week 72 (n = 29, 30, 29)	6.7 ( 25.98 )	2.7 ( 20.55 )	14.7 ( 30.63 )
Fatigue: Change at LTE Week 96 (n = 8, 14, 13)	21.1 ( 33.73 )	2.7 ( 23.09 )	20.2 ( 21.06 )

No statistical analyses for this end point

Secondary: Number of Subjects With Patient Global Impression of Change (PGIC)

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End point title

Number of Subjects With Patient Global Impression of Change (PGIC)

End point description

The PGIC is self-rated scale that asks the subject to describe the change in activity limitations, symptoms, emotions, and overall Quality of life (QoL) related to the subject's painful condition on the following scale: 1 (very much improved), 2 (much improved), 3 (minimally improved), 4 (no change), 5 (minimally worse), 6 (much worse) and 7 (very much worse). Number of subjects in the PGIC categories of very much improved (1) and much improved (2) are reported. mITT analysis set was defined as all enrolled subjects in the LTE study. Efficacy analyses were performed on the mITT analysis set according to randomized treatment. Here "n" signifies those subjects who were evaluable for this outcome measure at specified categories.

End point type

Secondary

End point timeframe

Baseline (Core Study Day 1); LTE Day 1, Week 24, Week 48, Week 72 and Week 96

End point values	Placebo/Atacicept 150 mg	Atacicept 75 mg	Atacicept 150 mg
Number of subjects analysed	83	82	88
Units: Subjects
LTE Day 1: Very much improved (n= 83, 82, 88)	13	19	25
LTE Day 1: Much improved (n= 83, 82, 88)	29	33	27
LTE Week 24: Very much improved (n= 74, 75, 83)	18	22	22
LTE Week 24: Much improved (n= 74, 75, 83)	35	29	40
LTE Week 48: Very much improved (n= 61, 63, 70)	16	20	24
LTE Week 48: Much improved (n= 61, 63, 70)	26	24	30
LTE Week 72: Very much improved (n= 33, 30, 32)	7	10	10
LTE Week 72: Much improved (n= 33, 30, 32)	13	13	13
LTE Week 96: Very much improved (n= 9, 14, 13)	4	2	7
LTE Week 96: Much improved (n= 9, 14, 13)	4	7	5

No statistical analyses for this end point

Secondary: Change from Baseline in EuroQoL 5 Dimension Instrument (EQ-5D) Score

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End point title

Change from Baseline in EuroQoL 5 Dimension Instrument (EQ-5D) Score

End point description

EQ-5D questionnaire comprised of 5 dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression measured on 3 levels; 1=no problem, 2=moderate problems, 3=extreme problems. This part, called the EQ-5D descriptive system, provides a 5-dimensional description of health status. 5 dimensional 3-level system was converted into single index utility score. Possible values for single index utility score ranged from -0.594 (severe problems in all dimensions) to 1.0 (no problem in all dimensions) on scale where 1 represented best possible health state. Baseline was defined as Day 1 of Core study. mITT analysis set was defined as all enrolled subjects in the LTE study. Efficacy analyses were performed on the mITT analysis set according to randomized treatment. Here "n" signifies those subjects who were evaluable for this endpoint at specified categories.

End point type

Secondary

End point timeframe

Baseline: Day 1 (Core Study), LTE Day 1, Week 24, Week 48, Week 72 and Week 96

End point values	Placebo/Atacicept 150 mg	Atacicept 75 mg	Atacicept 150 mg
Number of subjects analysed	83	82	88
Units: Units on a scale
arithmetic mean (standard deviation)
Baseline: Core Study Day 1 (n = 82, 82, 86)	0.736 ( 0.1707 )	0.775 ( 0.1754 )	0.751 ( 0.2388 )
Change at LTE Day 1 (n = 82, 82, 86)	0.038 ( 0.1764 )	0.042 ( 0.1759 )	0.070 ( 0.1912 )
Change at LTE Week 24 (n = 73, 75, 81)	0.078 ( 0.1651 )	0.024 ( 0.2207 )	0.072 ( 0.1933 )
Change at LTE Week 48 (n = 59, 62, 67)	0.065 ( 0.2050 )	0.045 ( 0.2393 )	0.076 ( 0.2414 )
Change at LTE Week 72 (n = 29, 30, 29)	0.045 ( 0.1531 )	0.000 ( 0.2126 )	0.087 ( 0.2609 )
Change at LTE Week 96 (n = 8, 14, 13)	0.138 ( 0.1257 )	-0.015 ( 0.1767 )	0.132 ( 0.1927 )

No statistical analyses for this end point

Secondary: Change from Baseline in EQ-5D Visual Analogue Scale (VAS) Scores

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End point title

Change from Baseline in EQ-5D Visual Analogue Scale (VAS) Scores

End point description

EQ-5D is a subject rated questionnaire to assess health-related QoL in terms of a single index value. The VAS component rates current health state on a scale from 0 millimeters (mm) (worst imaginable health state) to 100 mm (best imaginable health state); higher scores indicate a better health state. Baseline defined as Day 1 of core study. mITT analysis set was defined as all enrolled subjects in the LTE study. Efficacy analyses were performed on the mITT analysis set according to randomized treatment. Here "n" signifies those subjects who were evaluable for this endpoint at specified categories.

End point type

Secondary

End point timeframe

Baseline: Day 1 (Core Study), LTE Day 1, Week 24, Week 48, Week 72 and Week 96

End point values	Placebo/Atacicept 150 mg	Atacicept 75 mg	Atacicept 150 mg
Number of subjects analysed	83	82	88
Units: mm
arithmetic mean (standard deviation)
Baseline: Core Study Day 1 (n = 82, 82, 85)	61 ( 18.8 )	65 ( 21.4 )	65 ( 22.2 )
Change at LTE Day 1 (n = 82, 82, 85)	9 ( 16.0 )	11 ( 21.5 )	8 ( 18.1 )
Change at LTE Week 24 (n = 73, 75, 80)	13 ( 19.7 )	12 ( 21.4 )	11 ( 18.4 )
Change at LTE Week 48 (n = 59, 62, 66)	15 ( 18.4 )	14 ( 23.9 )	9 ( 19.6 )
Change at LTE Week 72 (n = 29, 30, 29)	12 ( 18.9 )	12 ( 19.6 )	10 ( 18.1 )
Change at LTE Week 96 (n = 8, 14, 13)	19 ( 17.6 )	12 ( 20.9 )	10 ( 21.6 )

No statistical analyses for this end point

Secondary: Change From Baseline in Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue Score

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End point title

Change From Baseline in Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue Score

End point description

The FACIT-Fatigue score was calculated according to a 13-item questionnaire that assesses self-reported fatigue and its impact upon daily activities and function. It uses a 5-point Likert-type scale (0 = not at all; 1 = a little bit; 2 = somewhat; 3 = quite a bit; 4 = very much). The sum of all responses resulted in the FACIT-Fatigue score for a total possible score of 0 (worse possible score) to 52 (best score). A higher score reflected an improvement in the subject's health status. mITT analysis set was defined as all enrolled subjects in the LTE study. Efficacy analyses were performed on the mITT analysis set according to randomized treatment. Here "n" signifies those subjects who were evaluable for this outcome measure at specified categories.

End point type

Secondary

End point timeframe

Baseline: Day 1 (Core study); LTE Day 1, Week 24, Week 48, Week 72 and Week 96

End point values	Placebo/Atacicept 150 mg	Atacicept 75 mg	Atacicept 150 mg
Number of subjects analysed	83	82	88
Units: Units on a scale
arithmetic mean (standard deviation)
Baseline; Day 1 (Core Study) (n= 81, 81, 86)	29 ( 10.1 )	32 ( 13.1 )	31 ( 13.1 )
Change at LTE Day 1 (n= 81, 80, 86)	4 ( 9.5 )	4 ( 10.2 )	4 ( 9.8 )
Change at LTE Week 24 (n= 72, 74, 81)	5 ( 10.1 )	3 ( 10.9 )	4 ( 9.9 )
Change at LTE Week 48 (n= 58, 61, 67)	5 ( 11.2 )	4 ( 12.3 )	5 ( 9.9 )
Change at LTE Week 72 (n= 29, 29, 29)	4 ( 11.3 )	2 ( 10.2 )	6 ( 10.2 )
Change at LTE Week 96 (n= 8, 14, 13)	13 ( 15.5 )	3 ( 8.4 )	9 ( 9.2 )

No statistical analyses for this end point

Secondary: Number of Subjects With at least one Adverse Event

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End point title

Number of Subjects With at least one Adverse Event

End point description

An Adverse event (AE) was defined as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease associated with the use of study drug, whether or not considered related to the study drug or worsening of pre-existing medical condition, whether or not related to study drug. Treatment-Emergent adverse events (TEAEs) are defined as events with an onset date on or after the date of first dose of study treatment in the core study and ongoing at LTE study entry, or occurring during LTE study. The safety analyses set included all subjects enrolled into the LTE study and who received at least 1 dose of planned study treatment. Subjects were analyzed according to the actual treatment they received.

End point type

Secondary

End point timeframe

Baseline (Day 1 of Core study) up to maximum duration of 167.7 weeks

End point values	Placebo/Atacicept 150 mg	Atacicept 75 mg	Atacicept 150 mg
Number of subjects analysed	83	82	88
Units: Subjects	68	67	76

No statistical analyses for this end point

Secondary: Number of Subjects With Columbia-Suicide Severity Rating Scale (C-SSRS) Score

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End point title

Number of Subjects With Columbia-Suicide Severity Rating Scale (C-SSRS) Score

End point description

The C-SSRS assesses the suicidal behavior (SB) and suicidal ideation (SI) in participants. Occurrence of SB after study entry is defined as having answered “yes” to a least 1 of the 4 SB subcategories (actual attempt, interrupted attempt, aborted attempt, and preparatory acts or behavior). Occurrence of SI is defined as having answered “yes” to at least 1 of the SI sub-categories (1) wish to be dead, (2) nonspecific active suicidal thoughts, (3) active SI with any methods (no plan) without intent to act, (4) active SI with some intent to act (without specific plan), and (5) active SI with specific plan and intent). The safety analyses set included all subjects enrolled into the LTE study and who received at least 1 dose of planned study treatment. Subjects were analyzed according to the actual treatment they received.

End point type

Secondary

End point timeframe

LTE Day 1, Week 24, Week 48, Week 72 and Week 98

End point values	Placebo/Atacicept 150 mg	Atacicept 75 mg	Atacicept 150 mg
Number of subjects analysed	83	82	88
Units: Subjects
Occurrence of SB at LTE Day 1 (n= 83, 82, 88)	0	0	0
Occurrence of SB at LTE Week 24 (n= 74, 75, 83)	0	0	0
Occurrence of SB at LTE Week 48 (n= 61, 63, 70)	0	0	0
Occurrence of SB at LTE Week 72 (n= 33, 30, 32)	0	0	0
Occurrence of SB at LTE Week 96 (n= 9, 14, 13)	0	0	0
Occurrence of SI at LTE Day 1 (83, 82, 88)	0	0	0
Occurrence of SI at LTE Week 24 (n= 74, 75, 83)	0	0	0
Occurrence of SI at LTE Week 48 (n= 61, 63, 70)	0	0	0
Occurrence of SI at LTE Week 72 (n= 33, 30, 32)	1	0	1
Occurrence of SI at LTE Week 96 (n= 9, 14, 13)	0	1	0

No statistical analyses for this end point

Adverse events

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Timeframe for reporting adverse events

Baseline up to maximum duration of 167.7 weeks

Adverse event reporting additional description

The safety analyses set included all subjects enrolled into the LTE study and who received at least 1 dose of planned study treatment. Subjects were analyzed according to the actual treatment they received.

Assessment type

Systematic

Dictionary name

MedDRA

Dictionary version

21.0

Reporting group title

Placebo/Atacicept 150 mg

Reporting group description

Subjects received atacicept 150 mg as once-weekly subcutaneous injection during this LTE study up to a maximum of 97.7 weeks.

Reporting group title

Atacicept 75 mg

Reporting group description

Subjects received atacicept 75 mg as once-weekly subcutaneous injection during this LTE study up to a maximum of 143.7 weeks.

Reporting group title

Atacicept 150 mg

Reporting group description

Subjects received atacicept 150 mg as once-weekly subcutaneous injection during this LTE study up to a maximum of 97.9 weeks.

Serious adverse events	Placebo/Atacicept 150 mg	Atacicept 75 mg	Atacicept 150 mg
Total subjects affected by serious adverse events
subjects affected / exposed	19 / 83 (22.89%)	13 / 82 (15.85%)	11 / 88 (12.50%)
number of deaths (all causes)	0	0	2
number of deaths resulting from adverse events
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Embryonal rhabdomyosarcoma
subjects affected / exposed	1 / 83 (1.20%)	0 / 82 (0.00%)	0 / 88 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Thyroid cancer
subjects affected / exposed	0 / 83 (0.00%)	0 / 82 (0.00%)	1 / 88 (1.14%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Breast cancer
subjects affected / exposed	0 / 83 (0.00%)	1 / 82 (1.22%)	0 / 88 (0.00%)
occurrences causally related to treatment / all	0 / 0	1 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Vascular disorders
Hypertension
subjects affected / exposed	0 / 83 (0.00%)	1 / 82 (1.22%)	1 / 88 (1.14%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Hypovolaemic shock
subjects affected / exposed	0 / 83 (0.00%)	0 / 82 (0.00%)	1 / 88 (1.14%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Thrombosis
subjects affected / exposed	1 / 83 (1.20%)	0 / 82 (0.00%)	0 / 88 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Vasculitis
subjects affected / exposed	0 / 83 (0.00%)	0 / 82 (0.00%)	1 / 88 (1.14%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Pregnancy, puerperium and perinatal conditions
Pregnancy
subjects affected / exposed	0 / 83 (0.00%)	1 / 82 (1.22%)	1 / 88 (1.14%)
occurrences causally related to treatment / all	0 / 0	0 / 1	1 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Reproductive system and breast disorders
Menorrhagia
subjects affected / exposed	1 / 83 (1.20%)	0 / 82 (0.00%)	0 / 88 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Respiratory, thoracic and mediastinal disorders
Pleural effusion
subjects affected / exposed	0 / 83 (0.00%)	0 / 82 (0.00%)	2 / 88 (2.27%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Pleurisy
subjects affected / exposed	0 / 83 (0.00%)	0 / 82 (0.00%)	1 / 88 (1.14%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Pulmonary mass
subjects affected / exposed	0 / 83 (0.00%)	1 / 82 (1.22%)	0 / 88 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Psychiatric disorders
Disorientation
subjects affected / exposed	1 / 83 (1.20%)	0 / 82 (0.00%)	0 / 88 (0.00%)
occurrences causally related to treatment / all	1 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Confusional state
subjects affected / exposed	0 / 83 (0.00%)	1 / 82 (1.22%)	0 / 88 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Injury, poisoning and procedural complications
Animal bite
subjects affected / exposed	0 / 83 (0.00%)	1 / 82 (1.22%)	0 / 88 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Overdose
subjects affected / exposed	1 / 83 (1.20%)	0 / 82 (0.00%)	0 / 88 (0.00%)
occurrences causally related to treatment / all	1 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Radius fracture
subjects affected / exposed	0 / 83 (0.00%)	1 / 82 (1.22%)	0 / 88 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Tendon rupture
subjects affected / exposed	0 / 83 (0.00%)	0 / 82 (0.00%)	1 / 88 (1.14%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Gun shot wound
subjects affected / exposed	1 / 83 (1.20%)	0 / 82 (0.00%)	0 / 88 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Concussion
subjects affected / exposed	1 / 83 (1.20%)	0 / 82 (0.00%)	0 / 88 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Cardiac disorders
Pericardial effusion
subjects affected / exposed	0 / 83 (0.00%)	1 / 82 (1.22%)	0 / 88 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Nervous system disorders
Cerebrovascular accident
subjects affected / exposed	0 / 83 (0.00%)	0 / 82 (0.00%)	1 / 88 (1.14%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 1
Seizure
subjects affected / exposed	0 / 83 (0.00%)	1 / 82 (1.22%)	0 / 88 (0.00%)
occurrences causally related to treatment / all	0 / 0	1 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Central nervous system lupus
subjects affected / exposed	0 / 83 (0.00%)	1 / 82 (1.22%)	0 / 88 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Blood and lymphatic system disorders
Haemolytic anaemia
subjects affected / exposed	0 / 83 (0.00%)	1 / 82 (1.22%)	0 / 88 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Lymphadenopathy
subjects affected / exposed	1 / 83 (1.20%)	0 / 82 (0.00%)	0 / 88 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Anaemia
subjects affected / exposed	0 / 83 (0.00%)	1 / 82 (1.22%)	0 / 88 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Neutropenia
subjects affected / exposed	0 / 83 (0.00%)	1 / 82 (1.22%)	0 / 88 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Leukopenia
subjects affected / exposed	0 / 83 (0.00%)	1 / 82 (1.22%)	0 / 88 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Pancytopenia
subjects affected / exposed	0 / 83 (0.00%)	1 / 82 (1.22%)	0 / 88 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Ear and labyrinth disorders
Meniere's disease
subjects affected / exposed	0 / 83 (0.00%)	1 / 82 (1.22%)	0 / 88 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Gastrointestinal disorders
Gastritis
subjects affected / exposed	0 / 83 (0.00%)	1 / 82 (1.22%)	1 / 88 (1.14%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Pancreatitis
subjects affected / exposed	0 / 83 (0.00%)	0 / 82 (0.00%)	1 / 88 (1.14%)
occurrences causally related to treatment / all	0 / 0	0 / 0	1 / 2
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Dyspepsia
subjects affected / exposed	1 / 83 (1.20%)	1 / 82 (1.22%)	0 / 88 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Abdominal pain
subjects affected / exposed	0 / 83 (0.00%)	0 / 82 (0.00%)	1 / 88 (1.14%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 1
Ascites
subjects affected / exposed	0 / 83 (0.00%)	1 / 82 (1.22%)	0 / 88 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Nausea
subjects affected / exposed	0 / 83 (0.00%)	1 / 82 (1.22%)	0 / 88 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Vomiting
subjects affected / exposed	0 / 83 (0.00%)	1 / 82 (1.22%)	0 / 88 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Hepatobiliary disorders
Cholecystitis
subjects affected / exposed	1 / 83 (1.20%)	0 / 82 (0.00%)	0 / 88 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Renal and urinary disorders
Calculus urinary
subjects affected / exposed	0 / 83 (0.00%)	0 / 82 (0.00%)	1 / 88 (1.14%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Haematuria
subjects affected / exposed	1 / 83 (1.20%)	0 / 82 (0.00%)	0 / 88 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Lupus nephritis
subjects affected / exposed	1 / 83 (1.20%)	0 / 82 (0.00%)	0 / 88 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Nephritic syndrome
subjects affected / exposed	1 / 83 (1.20%)	0 / 82 (0.00%)	0 / 88 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Acute kidney injury
subjects affected / exposed	0 / 83 (0.00%)	1 / 82 (1.22%)	0 / 88 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Nephrotic syndrome
subjects affected / exposed	0 / 83 (0.00%)	1 / 82 (1.22%)	0 / 88 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Renal colic
subjects affected / exposed	1 / 83 (1.20%)	0 / 82 (0.00%)	0 / 88 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Musculoskeletal and connective tissue disorders
Systemic lupus erythematosus
subjects affected / exposed	0 / 83 (0.00%)	2 / 82 (2.44%)	1 / 88 (1.14%)
occurrences causally related to treatment / all	0 / 0	0 / 3	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Osteoarthritis
subjects affected / exposed	1 / 83 (1.20%)	0 / 82 (0.00%)	0 / 88 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Infections and infestations
Herpes zoster
subjects affected / exposed	2 / 83 (2.41%)	0 / 82 (0.00%)	0 / 88 (0.00%)
occurrences causally related to treatment / all	1 / 2	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Osteomyelitis
subjects affected / exposed	1 / 83 (1.20%)	0 / 82 (0.00%)	0 / 88 (0.00%)
occurrences causally related to treatment / all	1 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Pharyngotonsillitis
subjects affected / exposed	0 / 83 (0.00%)	0 / 82 (0.00%)	1 / 88 (1.14%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Pneumonia
subjects affected / exposed	2 / 83 (2.41%)	2 / 82 (2.44%)	1 / 88 (1.14%)
occurrences causally related to treatment / all	0 / 2	0 / 2	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Pyelonephritis acute
subjects affected / exposed	0 / 83 (0.00%)	0 / 82 (0.00%)	1 / 88 (1.14%)
occurrences causally related to treatment / all	0 / 0	0 / 0	1 / 2
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Soft tissue infection
subjects affected / exposed	0 / 83 (0.00%)	1 / 82 (1.22%)	0 / 88 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Subcutaneous abscess
subjects affected / exposed	0 / 83 (0.00%)	0 / 82 (0.00%)	1 / 88 (1.14%)
occurrences causally related to treatment / all	0 / 0	0 / 0	1 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Oral Candidiasis
subjects affected / exposed	0 / 83 (0.00%)	1 / 82 (1.22%)	0 / 88 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Metabolism and nutrition disorders
Hypocalcaemia
subjects affected / exposed	0 / 83 (0.00%)	0 / 82 (0.00%)	1 / 88 (1.14%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Hypoglycaemia
subjects affected / exposed	1 / 83 (1.20%)	0 / 82 (0.00%)	0 / 88 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Hypokalaemia
subjects affected / exposed	0 / 83 (0.00%)	1 / 82 (1.22%)	0 / 88 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 2	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Hyperglycaemia
subjects affected / exposed	0 / 83 (0.00%)	1 / 82 (1.22%)	0 / 88 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0

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

Non-serious adverse events	Placebo/Atacicept 150 mg	Atacicept 75 mg	Atacicept 150 mg
Total subjects affected by non serious adverse events
subjects affected / exposed	65 / 83 (78.31%)	65 / 82 (79.27%)	75 / 88 (85.23%)
Vascular disorders
Hypertension
subjects affected / exposed	1 / 83 (1.20%)	4 / 82 (4.88%)	6 / 88 (6.82%)
occurrences all number	1	4	7
Nervous system disorders
Headache
subjects affected / exposed	11 / 83 (13.25%)	3 / 82 (3.66%)	10 / 88 (11.36%)
occurrences all number	13	4	17
General disorders and administration site conditions
Injection site pain
subjects affected / exposed	11 / 83 (13.25%)	4 / 82 (4.88%)	14 / 88 (15.91%)
occurrences all number	125	8	262
Injection site reaction
subjects affected / exposed	23 / 83 (27.71%)	14 / 82 (17.07%)	22 / 88 (25.00%)
occurrences all number	369	251	665
Injection site erythema
subjects affected / exposed	5 / 83 (6.02%)	3 / 82 (3.66%)	1 / 88 (1.14%)
occurrences all number	21	11	1
Gastrointestinal disorders
Gastritis
subjects affected / exposed	5 / 83 (6.02%)	2 / 82 (2.44%)	4 / 88 (4.55%)
occurrences all number	5	2	4
Musculoskeletal and connective tissue disorders
Back pain
subjects affected / exposed	3 / 83 (3.61%)	7 / 82 (8.54%)	4 / 88 (4.55%)
occurrences all number	4	7	4
Infections and infestations
Bronchitis
subjects affected / exposed	7 / 83 (8.43%)	10 / 82 (12.20%)	2 / 88 (2.27%)
occurrences all number	7	10	4
Nasopharyngitis
subjects affected / exposed	8 / 83 (9.64%)	8 / 82 (9.76%)	5 / 88 (5.68%)
occurrences all number	11	10	9
Pharyngitis
subjects affected / exposed	3 / 83 (3.61%)	6 / 82 (7.32%)	6 / 88 (6.82%)
occurrences all number	3	6	6
Upper respiratory tract infection
subjects affected / exposed	7 / 83 (8.43%)	11 / 82 (13.41%)	15 / 88 (17.05%)
occurrences all number	13	19	26
Urinary tract infection
subjects affected / exposed	18 / 83 (21.69%)	14 / 82 (17.07%)	17 / 88 (19.32%)
occurrences all number	31	18	24
Sinusitis
subjects affected / exposed	3 / 83 (3.61%)	7 / 82 (8.54%)	5 / 88 (5.68%)
occurrences all number	5	9	5

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Were there any global substantial amendments to the protocol? Yes

01 Sep 2014

Updated the coordinating investigator, medical responsible and contact information. total duration of treatment, updated EMR700461-023 to ADDRESS II, Updated dosage information to include the 150 mg dose given as 1 or 2 injections.

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.

The study was terminated early due to shortage of drug supply and there were many fewer number of participants remaining in each dosage group after Week 72 preluding meaningful inferences.

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Clinical trials

Clinical Trial Results: A Phase IIb, Multi-Center, Long-Term Extension Trial to Evaluate the Safety and Tolerability of Atacicept in Subjects with Systemic Lupus Erythematosus (SLE) who Completed Protocol EMR-700461-023 (ADDRESS II)

Trial information

Trial information

Subject disposition

Subject disposition

Baseline characteristics

Baseline characteristics

End points

End points

Primary: Number of Subjects With at least one Serious Adverse Event (SAE) During the Treatment Period

Primary: Number of Subjects With at least one Serious Adverse Event (SAE) During the Treatment Period

Primary: Number of Subjects who Prematurely Discontinued the Treatment due to Adverse Events (AEs)

Primary: Number of Subjects who Prematurely Discontinued the Treatment due to Adverse Events (AEs)

Secondary: Change from Baseline in Systemic Lupus International Collaborating Clinics/American College of Rheumatology (SLICC/ACR) Damage Index Organ Damage Scores

Secondary: Change from Baseline in Systemic Lupus International Collaborating Clinics/American College of Rheumatology (SLICC/ACR) Damage Index Organ Damage Scores

Secondary: Change from Baseline in Disease Activity as Measured by British Isles Lupus Assessment Group (BILAG) 2004 Score

Secondary: Change from Baseline in Disease Activity as Measured by British Isles Lupus Assessment Group (BILAG) 2004 Score

Secondary: Change from Baseline in Disease Activity as Measured by Systemic Lupus Erythematosus Disease Activity Index-2000 (SLEDAI-2K) Score

Secondary: Change from Baseline in Disease Activity as Measured by Systemic Lupus Erythematosus Disease Activity Index-2000 (SLEDAI-2K) Score

Secondary: Change from Baseline in Disease Activity as Measured by SLEDAI-2K Responder Index-50 (SRI-50) Score

Secondary: Change from Baseline in Disease Activity as Measured by SLEDAI-2K Responder Index-50 (SRI-50) Score

Secondary: Change from Baseline in Disease Activity as Measured by Physician's Global Assessment (PGA) Score

Secondary: Change from Baseline in Disease Activity as Measured by Physician's Global Assessment (PGA) Score

Secondary: Number of Subjects who Achieved SLE Responder Index (SRI-4) Response (a Disease Activity Composite Index)

Secondary: Number of Subjects who Achieved SLE Responder Index (SRI-4) Response (a Disease Activity Composite Index)

Secondary: Number of Subjects who Achieved BILAG-based Combined Lupus Assessment (BICLA) Response (a Disease Activity Composite Index)

Secondary: Number of Subjects who Achieved BILAG-based Combined Lupus Assessment (BICLA) Response (a Disease Activity Composite Index)

Secondary: Percent Change from Baseline in Prednisone-equivalent Corticosteroid Dose

Secondary: Percent Change from Baseline in Prednisone-equivalent Corticosteroid Dose

Secondary: Change From Baseline in the Short-Form (SF-36) Health Survey Physical Component Score and Mental Component Score

Secondary: Change From Baseline in the Short-Form (SF-36) Health Survey Physical Component Score and Mental Component Score

Secondary: Change from Baseline in Lupus Quality of Life (LupusQoL) Questionnaire Score

Secondary: Change from Baseline in Lupus Quality of Life (LupusQoL) Questionnaire Score

Secondary: Number of Subjects With Patient Global Impression of Change (PGIC)

Secondary: Number of Subjects With Patient Global Impression of Change (PGIC)

Secondary: Change from Baseline in EuroQoL 5 Dimension Instrument (EQ-5D) Score

Secondary: Change from Baseline in EuroQoL 5 Dimension Instrument (EQ-5D) Score

Secondary: Change from Baseline in EQ-5D Visual Analogue Scale (VAS) Scores

Secondary: Change from Baseline in EQ-5D Visual Analogue Scale (VAS) Scores

Secondary: Change From Baseline in Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue Score

Secondary: Change From Baseline in Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue Score

Secondary: Number of Subjects With at least one Adverse Event

Secondary: Number of Subjects With at least one Adverse Event

Secondary: Number of Subjects With Columbia-Suicide Severity Rating Scale (C-SSRS) Score

Secondary: Number of Subjects With Columbia-Suicide Severity Rating Scale (C-SSRS) Score

Adverse events

Adverse events

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Substantial protocol amendments (globally)

Interruptions (globally)

Limitations and caveats

More information

Clinical Trial Results:
A Phase IIb, Multi-Center, Long-Term Extension Trial to Evaluate the Safety and Tolerability of Atacicept in Subjects with Systemic Lupus Erythematosus (SLE) who Completed Protocol EMR-700461-023 (ADDRESS II)