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    Clinical Trial Results:
    Efficacy, Safety, and Immunogenicity of BI 695501 versus Humira® in Patients with Moderate to Severe Chronic Plaque Psoriasis: A Randomized, Double-Blind, Parallel-Arm, Multiple-Dose, Active Comparator Trial

    Summary
    EudraCT number
    		 2016-000613-79
    Trial protocol
    		 DE   CZ   SK   PL  
    Global end of trial date
    17 Jan 2018

    Results information
    Results version number
    		 v1(current)
    This version publication date
    01 Feb 2019
    First version publication date
    01 Feb 2019
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    1297.12
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT02850965
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Boehringer Ingelheim
    Sponsor organisation address
    Binger Strasse 173, Ingelheim am Rhein, Germany, 55216
    Public contact
    QRPE Processes and Systems Coordination, Clinical Trial Information Disclosure, Boehringer Ingelheim, 001 8002430127, clintriage.rdg@boehringer-ingelheim.com
    Scientific contact
    QRPE Processes and Systems Coordination, Clinical Trial Information Disclosure, Boehringer Ingelheim, 001 8002430127, clintriage.rdg@boehringer-ingelheim.com
    Paediatric regulatory details
    Is trial part of an agreed paediatric investigation plan (PIP)
    No
    Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Results analysis stage
    Analysis stage
    Final
    Date of interim/final analysis
    06 Feb 2018
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    17 Jan 2018
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The primary objective of this trial was to establish equivalence in efficacy between BI 695501 and US-licensed Humira® at Week 16 in patients with active moderate to severe chronic plaque psoriasis.
    Protection of trial subjects
    Only patients that met all the study inclusion and none of the exclusion criteria were to be randomized in the study. All patients were free to withdraw from the clinical trial at any time for any reason given. Close monitoring of all patients was adhered to throughout the trial conduct.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    21 Sep 2016
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    No
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    United States: 109
    Country: Number of subjects enrolled
    Czech Republic: 32
    Country: Number of subjects enrolled
    Estonia: 3
    Country: Number of subjects enrolled
    Germany: 32
    Country: Number of subjects enrolled
    Poland: 81
    Country: Number of subjects enrolled
    Russian Federation: 66
    Country: Number of subjects enrolled
    Slovakia: 11
    Country: Number of subjects enrolled
    Ukraine: 90
    Worldwide total number of subjects
    424
    EEA total number of subjects
    159
    Number of subjects enrolled per age group
    In utero
    0
    Preterm newborn - gestational age < 37 wk
    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)
    395
    From 65 to 84 years
    29
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 Phase III, multinational, randomized, double-blind, parallel-arm, multiple-dose, active-comparator trial of BI 695501 and US-licensed Humira with a 24-week treatment period and 10 weeks of safety follow up, in patients with moderate to severe chronic plaque psoriasis.

    Pre-assignment
    Screening details
    		 All patients were screened for eligibility to participate in the trial. Patients attended a specialist sites which ensured that they (the patients) met all strictly implemented inclusion/exclusion criteria. Patients were not to be entered to trial treatment if any one of the specific entry criteria was violated.

    Period 1
    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, Monitor, Data analyst, Carer, Assessor
    Blinding implementation details
    This was a double-blind trial.

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 BI 695501
    Arm description
    		 Patients were administered with BI 695501 via subcutaneous (SC) injection 80 milligram (mg) on Day 1 and 40 milligram (mg) on every other week from Week 1 to Week 23.
    Arm type
    		 Experimental

    Investigational medicinal product name
    BI 695501
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Patients were administered with BI 695501 via subcutaneous (SC) injection 80 milligram (mg) on Day 1 and 40 milligram (mg) on every other week from Week 1 to Week 23.

    Arm title
    		 US-licensed Humira
    Arm description
    		 Patients were administered US-licensed Humira via subcutaneous (SC) injection 80 mg on Day 1 and 40 milligram on every other week from Week 1 to Week 23.
    Arm type
    		 Active comparator

    Investigational medicinal product name
    US-licensed Humira
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Patients were administered US-licensed Humira via subcutaneous (SC) injection 80 mg on Day 1 and 40 milligram on every other week from Week 1 to Week 23.

    Number of subjects in period 1 [1]
    		BI 695501 US-licensed Humira
    Started
    159
    158
    Completed
    141
    134
    Not completed
    18
    24
         Consent withdrawn by subject
    3
    4
         Physician decision
    -
    1
         Adverse event, non-fatal
    3
    2
         Lost to follow-up
    5
    3
         Other than listed
    3
    4
         Lack of efficacy
    4
    8
         Protocol deviation
    -
    2
    Notes
    [1] - The number of subjects reported to be in the baseline period are not the same as the worldwide number enrolled in the trial. It is expected that these numbers will be the same.
    Justification: Baseline characteristics are based on patients who were randomised after successfully completing the screening period and received at least one dose of the trial medication.

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    BI 695501
    Reporting group description
    		 Patients were administered with BI 695501 via subcutaneous (SC) injection 80 milligram (mg) on Day 1 and 40 milligram (mg) on every other week from Week 1 to Week 23.

    Reporting group title
    US-licensed Humira
    Reporting group description
    		 Patients were administered US-licensed Humira via subcutaneous (SC) injection 80 mg on Day 1 and 40 milligram on every other week from Week 1 to Week 23.

    Reporting group values
    		 BI 695501 US-licensed Humira Total
    Number of subjects
    		 159 158 317
    Age categorical
    Units: Subjects
    Age Continuous
    Safety Analysis Set (SAF): The SAF contained all patients who provided signed informed consent, who were randomized, and who received at least one dose of trial medication.
    Units: years
        arithmetic mean (standard deviation)
    		 42.1 ± 12.79 44.7 ± 13.92 -
    Sex: Female, Male
    SAF
    Units: Subjects
        Female
    		 58 56 114
        Male
    		 101 102 203
    Race (NIH/OMB)
    SAF
    Units: Subjects
        American Indian or Alaska Native
    		 0 0 0
        Asian
    		 0 0 0
        Native Hawaiian or Other Pacific Islander
    		 0 1 1
        Black or African American
    		 1 1 2
        White
    		 157 156 313
        More than one race
    		 0 0 0
        Unknown or Not Reported
    		 1 0 1
    Ethnicity (NIH/OMB)
    SAF
    Units: Subjects
        Hispanic or Latino
    		 12 10 22
        Not Hispanic or Latino
    		 147 146 293
        Unknown or Not Reported
    		 0 2 2

    End points

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    End points reporting groups
    Reporting group title
    BI 695501
    Reporting group description
    		 Patients were administered with BI 695501 via subcutaneous (SC) injection 80 milligram (mg) on Day 1 and 40 milligram (mg) on every other week from Week 1 to Week 23.

    Reporting group title
    US-licensed Humira
    Reporting group description
    		 Patients were administered US-licensed Humira via subcutaneous (SC) injection 80 mg on Day 1 and 40 milligram on every other week from Week 1 to Week 23.

    Primary: The percentage of patients with at least 75% reduction in Psoriasis Area and Severity Index (PASI 75) response at Week 16

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    End point title
    		 The percentage of patients with at least 75% reduction in Psoriasis Area and Severity Index (PASI 75) response at Week 16
    End point description
    PASI tool provides numeric scoring for a patient’s overall psoriasis disease state, ranging from 0 to 72. Head(h),trunk(t),upper extremities(u) and lower extremities(l) areas were assessed; correspond to 10,30,20and40% of the total body area. Lesions were assessed using numeric scale of 0 to 4 where 0 was complete lack of cutaneous involvement and 4 was severest possible involvement. Area of psoriatic involvement of areas (Ah, At, Au, and Al) was given a numerical value: 0 = no involvement, 1=<10%, 2=10 to <30%, 3=30 to <50%, 4=50 to <70%, 5=70 to <90%, and 6=90 to 100%involvement.PASI=0.1(Eh+Ih+Dh)Ah+0.3(Et+It+Dt)At+0.2(Eu+Iu+Du)Au+0.4(El+Il+Dl)Al. Percentage=least squares means per treatment groups back transformed using inverse logit function. Full Analysis Set(FAS) contained all randomized patients who received at least one dose of trial medication, and had all efficacy measures relevant for the PASI 75,measured at baseline and at least once post-baseline (prior to or on Week16).
    End point type
    Primary
    End point timeframe
    Week 16
    End point values
    		 BI 695501 US-licensed Humira
    Number of subjects analysed
    158 [1]
    157 [2]
    Units: Percentage (%)
        number (not applicable)
    68.2
    70.4
    Notes
    [1] - FAS
    [2] - FAS
    Statistical analysis title
    		 Statistical Analysis 1
    Statistical analysis description
    Week16 confidence interval for estimated difference in percentage are produced using cumulative distribution function method of Reeve. Statistical model: Logit (response to treatment at Week16)=Treatment+Baseline PASI+Prior exposure to a biologic agent+random error. Model included fixed, categorical effects of treatment (BI 695501 vs US-licensed Humira) and prior exposure to a biologic agent (yes/no), continuous effect of baseline PASI. The random error was assumed to be binomially distributed.
    Comparison groups
    BI 695501 v US-licensed Humira
    Number of subjects included in analysis
    315
    Analysis specification
    Pre-specified
    Analysis type
    		 equivalence [3]
    Method
    		 Regression, Logistic
    Parameter type
    		 Difference in PASI 75 Response Rate
    Point estimate
    -2.2
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -14.4
         upper limit
    		 8.7
    Notes
    [3] - Protocol defined margins are: [-18.0%, +18.0%] for Week 16, 95% confidence interval. Between-imputation variance is zero. Confidence interval is based on one imputed set. Difference in PASI 75 Response Rate = (BI 695501 – US-licensed Humira, %)

    Secondary: The percentage of patients with a PASI 75 response at Week 24

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    End point title
    		 The percentage of patients with a PASI 75 response at Week 24
    End point description
    The PASI tool provides numeric scoring for a patient’s overall psoriasis disease state, ranging from 0 to 72. Head (h), trunk (t), upper extremities (u) and lower extremities (l) areas were assessed; correspond to 10, 30, 20, and 40% of the total body area, respectively. The signs of severity, erythema (E), induration (I) and desquamation (D) of lesions were assessed using a numeric scale of 0 to 4 where 0 was a complete lack of cutaneous involvement and 4 was the severest possible involvement. The area of psoriatic involvement of these areas (Ah, At, Au, and Al) was given a numerical value: 0 = no involvement, 1 = <10%, 2 = 10 to <30%, 3 = 30 to <50%, 4 = 50 to <70%, 5 = 70 to <90%, and 6 = 90 to 100% involvement. PASI = 0.1(Eh+Ih+Dh)Ah + 0.3(Et+It+Dt)At + 0.2(Eu+Iu+Du)Au + 0.4(El+Il+Dl)Al. Percentage = least squares means per treatment groups back transformed using inverse logit function.
    End point type
    Secondary
    End point timeframe
    Week 24
    End point values
    		 BI 695501 US-licensed Humira
    Number of subjects analysed
    158 [4]
    157 [5]
    Units: Percentage (%)
        number (not applicable)
    75.3
    72.4
    Notes
    [4] - FAS
    [5] - FAS
    Statistical analysis title
    		 Statistical Analysis 1
    Statistical analysis description
    Week 24 confidence interval for estimated difference in percentage are produced using cumulative distribution function method of Reeve. Statistical model: Logit (response to treatment at Week 24)=Treatment+Baseline PASI+Prior exposure to a biologic agent+random error. Model included fixed, categorical effects of treatment (BI 695501 vs US-licensed Humira) and prior exposure to biologic agent (yes/no), continuous effect of baseline PASI. The random error was assumed to be binomially distributed.
    Comparison groups
    BI 695501 v US-licensed Humira
    Number of subjects included in analysis
    315
    Analysis specification
    Pre-specified
    Analysis type
    		 other [6]
    Method
    		 Regression, Logistic
    Parameter type
    		 Difference in PASI 75 Response Rate
    Point estimate
    2.9
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -8.5
         upper limit
    		 12.6
    Notes
    [6] - Missing PASI 75 at Week 24 data were imputed using a combination of non-responder imputation (NRI) and last observed carried forward (LOCF). Difference in PASI 75 Response Rate = (BI 695501 – US-licensed Humira, %).

    Secondary: The mean percentage improvement in PASI at Week 16

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    End point title
    		 The mean percentage improvement in PASI at Week 16
    End point description
    The PASI tool provides numeric scoring for a patient’s overall psoriasis disease state, ranging from 0 to 72. Head (h), trunk (t), upper extremities (u) and lower extremities (l) areas were assessed; correspond to 10, 30, 20, and 40% of the total body area, respectively. The signs of severity, erythema (E), induration (I) and desquamation (D) of lesions were assessed using a numeric scale of 0 to 4 where 0 was a complete lack of cutaneous involvement and 4 was the severest possible involvement. The area of psoriatic involvement of these areas (Ah, At, Au, and Al) was given a numerical value: 0 = no involvement, 1 =<10%, 2 =10 to <30%, 3 =30 to <50%, 4 =50 to <70%, 5 =70 to <90%, and 6 =90 to 100% involvement. PASI = 0.1(Eh+Ih+Dh)Ah + 0.3(Et+It+Dt)At + 0.2(Eu+Iu+Du)Au + 0.4(El+Il+Dl)Al. Results based on PASI mean percentage improvement from Baseline after 16 weeks of treatment = overall mean + treatment group + Baseline PASI + prior exposure to a biological agent + random error.
    End point type
    Secondary
    End point timeframe
    Week 16
    End point values
    		 BI 695501 US-licensed Humira
    Number of subjects analysed
    149 [7]
    149 [8]
    Units: Percentage (%)
        least squares mean (confidence interval 95%)
    83.7 (80.2 to 87.2)
    82.1 (78.6 to 85.6)
    Notes
    [7] - FAS
    [8] - FAS
    Statistical analysis title
    		 Statistical Analysis 1
    Statistical analysis description
    Analysis of covariance (ANCOVA) was performed based on the following model: PASI percentage improvement from baseline at Week 16= Treatment + Baseline PASI +Prior exposure to a biologic agent + random error.
    Comparison groups
    BI 695501 v US-licensed Humira
    Number of subjects included in analysis
    298
    Analysis specification
    Pre-specified
    Analysis type
    		 other [9]
    Method
    		 ANCOVA
    Parameter type
    		 Difference of Least Squares Means (LSM)
    Point estimate
    1.7
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -2.7
         upper limit
    		 6
    Notes
    [9] - Difference of LSM = LSM of (BI 695501 – Humira)

    Secondary: The percentage of patients with a Static Physician’s Global Assessment (sPGA) ≤1 (clear or almost clear) at Week 16

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    End point title
    		 The percentage of patients with a Static Physician’s Global Assessment (sPGA) ≤1 (clear or almost clear) at Week 16
    End point description
    The Static Physician’s Global Assessment (sPGA) is a 5-point score ranging from 0 to 4, based on the physician’s assessment of the average thickness, erythema, and scaling of all psoriatic lesions. The assessment was considered “static”, which referred to the patient’s disease state at the time of the assessment, without comparison to any of the patient’s previous disease states (dynamic), whether at Baseline or at a previous visit. A lower score indicated less body coverage, with 0 being clear, 1 being almost clear, and 4 being. Percentage = least squares means per treatment groups back transformed using inverse logit function.
    End point type
    Secondary
    End point timeframe
    Week 16
    End point values
    		 BI 695501 US-licensed Humira
    Number of subjects analysed
    158 [10]
    157 [11]
    Units: Percentage (%)
        number (not applicable)
    59.6
    52.1
    Notes
    [10] - FAS
    [11] - FAS
    Statistical analysis title
    		 Statistical Analysis 1
    Statistical analysis description
    Week16 confidence interval for the estimated difference in percentage are produced using the cumulative distribution function method of Reeve. Statistical model: Logit (response to treatment at Week16)=Treatment+Baseline PASI+Prior exposure to a biologic agent+random error. Model included fixed, categorical effects of treatment (BI 695501 vs US-licensed Humira) and prior exposure to a biologic agent (yes/no), continuous effect of baseline PASI.
    Comparison groups
    BI 695501 v US-licensed Humira
    Number of subjects included in analysis
    315
    Analysis specification
    Pre-specified
    Analysis type
    		 other [12]
    Method
    		 Regression, Logistic
    Parameter type
    		 Difference in sPGA <= 1 Response Rate
    Point estimate
    7.5
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -4.8
         upper limit
    		 19.1
    Notes
    [12] - Missing sPGA at Week 16 data were imputed using a combination of non-responder imputation (NRI) and last observed carried forward (LOCF). Difference in sPGA <= 1 Response Rate = (BI 695501 – US-licensed Humira, %).

    Secondary: The percentage of patients achieving a Dermatology Life Quality Index (DLQI) of 0 or 1 at Week 16

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    End point title
    		 The percentage of patients achieving a Dermatology Life Quality Index (DLQI) of 0 or 1 at Week 16
    End point description
    The DLQI is a subject-administered, 10-question, that covers 6 domains including symptoms and feelings, daily activities, leisure, work and school, personal relationships, and treatment. It has a 1-week recall period. Every item score ranges from 0 (not relevant/not at all) to 3 (very much). Question 7 is a “yes/no” question where “yes” is scored as 3. The DLQI total score was calculated by summing the scores of each question resulting in a range of 0 to 30 where 0-1 = no effect on subject’s life, 2-5 = small effect, 6-10 = moderate effect, 11-20 = very large effect, and 21-30 = extremely large effect on the subject’s life. The higher the score, the more the quality of life is impaired. If the answer to 1 question in a domain was missing, that domain was treated as missing. If 2 or more questions were left unanswered (missing), DLQI total score was treated as missing. Percentage = least squares means per treatment groups back transformed using inverse logit function.
    End point type
    Secondary
    End point timeframe
    Week 16
    End point values
    		 BI 695501 US-licensed Humira
    Number of subjects analysed
    158 [13]
    157 [14]
    Units: Percentage (%)
        number (not applicable)
    67.2
    66.8
    Notes
    [13] - FAS
    [14] - FAS
    Statistical analysis title
    		 Statistical Analysis 1
    Statistical analysis description
    Week16 confidence interval for estimated difference in percentage are produced using cumulative distribution function method of Reeve. Statistical model: Logit (response to treatment at Week16)=Treatment+Baseline PASI+Prior exposure to a biologic agent+random error. Model included fixed, categorical effects of treatment (BI 695501 vs US-licensed Humira) and prior exposure to a biologic agent (yes/no), continuous effect of baseline PASI.
    Comparison groups
    BI 695501 v US-licensed Humira
    Number of subjects included in analysis
    315
    Analysis specification
    Pre-specified
    Analysis type
    		 other [15]
    Method
    		 Regression, Logistic
    Parameter type
    		 Difference in DLQI Response Rate
    Point estimate
    0.4
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -11.7
         upper limit
    		 11.3
    Notes
    [15] - Missing DLQI at Week 16 data were imputed using a combination of non-responder imputation (NRI) and last observed carried forward (LOCF). Difference in DLQI (0, 1) Response Rate = (BI 695501 – US-licensed Humira, %).

    Secondary: The percentage of patients with drug-related adverse events (AEs)

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    End point title
    		 The percentage of patients with drug-related adverse events (AEs)
    End point description
    The secondary safety endpoint was defined as the percentage of patients with drug-related adverse events (AEs). Safety Analysis Set (SAF): The SAF contained all patients who provided signed informed consent, who were randomized, and who received at least one dose of trial medication.
    End point type
    Secondary
    End point timeframe
    From first drug administration until 10 weeks after last drug administration, up to 33 weeks.
    End point values
    		 BI 695501 US-licensed Humira
    Number of subjects analysed
    159 [16]
    158 [17]
    Units: Percentage of patients (%)
        number (not applicable)
    13.2
    20.3
    Notes
    [16] - SAF
    [17] - SAF
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    From first drug administration until 10 weeks after last drug administration, up to 33 weeks.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    20.1
    Reporting groups
    Reporting group title
    BI 695501
    Reporting group description
    		 Patients were administered with BI 695501 via subcutaneous (SC) injection 80 milligram (mg) on Day 1 and 40 milligram (mg) on every other week from Week 1 to Week 23.

    Reporting group title
    US-licensed Humira
    Reporting group description
    		 Patients were administered US-licensed Humira via subcutaneous (SC) injection 80 mg on Day 1 and 40 milligram on every other week from Week 1 to Week 23.

    Serious adverse events
    		 BI 695501 US-licensed Humira
    Total subjects affected by serious adverse events
         subjects affected / exposed
    5 / 159 (3.14%)
    7 / 158 (4.43%)
         number of deaths (all causes)
    0
    0
         number of deaths resulting from adverse events
    0
    0
    Cardiac disorders
    Congestive cardiomyopathy
         subjects affected / exposed
    1 / 159 (0.63%)
    0 / 158 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pericarditis
         subjects affected / exposed
    0 / 159 (0.00%)
    1 / 158 (0.63%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Nervous system disorders
    Transient ischaemic attack
         subjects affected / exposed
    0 / 159 (0.00%)
    1 / 158 (0.63%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastrointestinal disorders
    Pancreatitis chronic
         subjects affected / exposed
    0 / 159 (0.00%)
    1 / 158 (0.63%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hepatobiliary disorders
    Hepatitis toxic
         subjects affected / exposed
    0 / 159 (0.00%)
    1 / 158 (0.63%)
         occurrences causally related to treatment / all
    0 / 0
    2 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Skin and subcutaneous tissue disorders
    Psoriasis
         subjects affected / exposed
    1 / 159 (0.63%)
    0 / 158 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Renal and urinary disorders
    Renal colic
         subjects affected / exposed
    0 / 159 (0.00%)
    1 / 158 (0.63%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Musculoskeletal and connective tissue disorders
    Exostosis
         subjects affected / exposed
    0 / 159 (0.00%)
    1 / 158 (0.63%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Foot deformity
         subjects affected / exposed
    0 / 159 (0.00%)
    1 / 158 (0.63%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Infections and infestations
    Abdominal abscess
         subjects affected / exposed
    1 / 159 (0.63%)
    0 / 158 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Furuncle
         subjects affected / exposed
    0 / 159 (0.00%)
    1 / 158 (0.63%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Kidney infection
         subjects affected / exposed
    0 / 159 (0.00%)
    1 / 158 (0.63%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Oral herpes
         subjects affected / exposed
    1 / 159 (0.63%)
    0 / 158 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Orchitis
         subjects affected / exposed
    0 / 159 (0.00%)
    1 / 158 (0.63%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Upper respiratory tract infection
         subjects affected / exposed
    1 / 159 (0.63%)
    0 / 158 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 BI 695501 US-licensed Humira
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    17 / 159 (10.69%)
    24 / 158 (15.19%)
    General disorders and administration site conditions
    Injection site pain
         subjects affected / exposed
    3 / 159 (1.89%)
    10 / 158 (6.33%)
         occurrences all number
    3
    29
    Injection site erythema
         subjects affected / exposed
    5 / 159 (3.14%)
    10 / 158 (6.33%)
         occurrences all number
    10
    24
    Infections and infestations
    Nasopharyngitis
         subjects affected / exposed
    12 / 159 (7.55%)
    7 / 158 (4.43%)
         occurrences all number
    14
    7

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? No

    Interruptions (globally)
    Were there any global interruptions to the trial? No

    Limitations and caveats
    Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data.
    None reported
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