Psoriasis, Plaque Type Psoriasis, Moderate to Severe Plaque Psoriasis
Conditions
Keywords
Adalimumab, MSB11022, Psoriasis, Phase III
Brief summary
The purpose of this study was to compare the efficacy, safety and immunogenicity of MSB11022 and Humira® in adult subjects with moderate to severe chronic plaque type psoriasis.
Interventions
Sponsors
Merck KGaA, Darmstadt, Germany
Fresenius Kabi SwissBioSim GmbH
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Male or female participants greater than or equal to (\>=) 18 years old with a clinical diagnosis of stable moderate to severe plaque psoriasis (defined by Psoriasis Area and Severity Index \[PASI\] score \>=12, Physician Global Assessment \[PGA\] score \>=3, and \>=10% of body surface area affected at Screening and Baseline \[Day 1 of Week 1\]) who have a history of receipt of or are candidates for systemic therapy or phototherapy for active plaque-type psoriasis despite topical therapy * Participants must not have received more than 1 biologic therapy * Other protocol-defined inclusion criteria could apply
Exclusion criteria
* Participants was excluded if they have erythrodermic, pustular, guttate, or medication-induced forms of psoriasis or other active skin diseases/infections that may interfere with the evaluation of plaque psoriasis * Participants must not have received adalimumab or an investigational or licensed biosimilar of adalimumab; topical therapies for the treatment of psoriasis or ultraviolet B phototherapy within 2 weeks of investigational medicinal product (IMP) administration or plan to take such treatment during the trial; or psoralen combined with ultraviolet A phototherapy or nonbiological systemic therapies for psoriasis within 4 weeks prior to IMP administration * Participants was excluded if they have a history of an ongoing, chronic, or recurrent infectious disease (except for latent tuberculosis \[TB\]); history of active TB; or a history of hypersensitivity to any component of the IMP formulation, comparable drugs, or latex * Other protocol-defined
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants Who Achieved Psoriasis Area and Severity Index 75 (PASI 75) at Week 16 | Week 16 | PASI correlates to the physician's assessment of psoriasis symptoms including redness of lesions, thickness of lesions, scaliness of lesions and extent of disease. Each parameter is graded from 0-4, 0 refers to no disease and 4 to severe involvement. The body is divided into 4 areas for scoring (head, arms, trunk to groin, legs to top of buttocks), and the final score ranges from 0-72 with higher scores reflecting more disease severity. The PASI-75 response is defined as the percentage of participants who achieved at least a 75% improvement in PASI score from Baseline. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants Who Achieved PASI 50, 90 and 100 at Week 16 | Week 16 | PASI correlates to the physician's assessment of psoriasis symptoms including redness of lesions, thickness of lesions, scaliness of lesions and extent of disease. Each parameter is graded from 0-4, 0 refers to no disease and 4 to severe involvement. The body is divided into 4 areas for scoring (head, arms, trunk to groin, legs to top of buttocks), and the final score ranges from 0-72 with higher scores reflecting more disease severity. The PASI 50, 90 and 100 response rate at Week 16 is measured as the percentage of participants who achieved at least 50, 90 and 100% improvement from baseline PASI score at Week 16. |
| Percentage of Participants Who Achieved PASI 50, 75, 90 and 100 at Week 24 | Week 24 | PASI correlates to the physician's assessment of psoriasis symptoms including redness of lesions, thickness of lesions, scaliness of lesions and extent of disease. Each parameter is graded from 0-4, 0 refers to no disease and 4 to severe involvement. The body is divided into 4 areas for scoring (head, arms, trunk to groin, legs to top of buttocks), and the final score ranges from 0-72 with higher scores reflecting more disease severity. The PASI response rate at Week 24 is measured as the percentage of participants who achieved at least 50, 75, 90 and 100% improvement from baseline PASI at Week 24. |
| Percentage of Participants Who Achieved PASI 50, 75, 90 and 100 at Week 52 | Week 52 | PASI correlates to the physician's assessment of psoriasis symptoms including redness of lesions, thickness of lesions, scaliness of lesions and extent of disease. Each parameter is graded from 0-4, 0 refers to no disease and 4 to severe involvement. The body is divided into 4 areas for scoring (head, arms, trunk to groin, legs to top of buttocks), and the final score ranges from 0-72 with higher scores reflecting more disease severity. The PASI response rate at Week 52 is measured as the percentage of participants who achieved at least 50, 75, 90 and 100% improvement from baseline PASI at Week 52. |
| Percent Change From Baseline in PASI at Week 24 and 52 | Baseline (Day 1 of Extended Treatment Period), Weeks 24 and 52 | PASI correlates to the physician's assessment of psoriasis symptoms including redness of lesions, thickness of lesions, scaliness of lesions and extent of disease. Each parameter is graded from 0-4, 0 refers to no disease and 4 to severe involvement. The body is divided into 4 areas for scoring (head, arms, trunk to groin, legs to top of buttocks), and the final score ranges from 0-72, with higher scores reflecting more disease severity. |
| Number of Participants With Change From Baseline in Physician's Global Assessment (PGA) Score to Clear or Almost Clear at Week 16 | Baseline (Day 1 of Core Treatment Period), Week 16 | PGA was assessed relative to baseline condition based on a scale ranged from 0 to 4, where 0 indicates Clear condition (no signs of psoriasis, post-inflammatory hyperpigmentation may be present), 1 indicates Almost clear condition (normal to pink coloration of lesion, no thickening and no to minimal \[focal\] scaling), 2 indicates Mild condition (pink to light red coloration, just detectable to mild thickening and predominantly fine scaling), 3 indicates Moderate condition (dull bright red, clearly distinguishable erythema, clearly distinguishable to moderate thickening and moderate scaling), and 4 indicates Severe condition (bright to deep dark red coloration, severe thickening with hard edges and severe/coarse scaling covering almost all or all lesions). |
| Number of Participants With Change From Baseline in Physician's Global Assessment (PGA) Score to Clear or Almost Clear at Week 24 and 52 | Baseline (Day 1 of Extended Treatment Period), Week 24 and 52 | PGA was assessed relative to baseline condition based on a scale ranged from 0 to 4, where 0 indicates clear condition (no signs of psoriasis, post-inflammatory hyperpigmentation may be present), 1 indicates Almost clear condition (normal to pink coloration of lesion, no thickening and no to minimal \[focal\] scaling), 2 indicates mild condition (pink to light red coloration, just detectable to mild thickening and predominantly fine scaling), 3 indicates moderate condition (dull bright red, clearly distinguishable erythema, clearly distinguishable to moderate thickening and moderate scaling), and 4 indicates severe condition (bright to deep dark red coloration, severe thickening with hard edges and severe/coarse scaling covering almost all or all lesions). |
| Time to Achieve PASI 50 | Baseline (Day 1 of Core Treatment Period) up to Month 4 | PASI correlates to the physician's assessment of psoriasis symptoms including redness of lesions, thickness of lesions, scaliness of lesions and extent of disease. Each parameter is graded from 0-4, 0 refers to no disease and 4 to severe involvement. The body is divided into 4 areas for scoring (head, arms, trunk to groin, legs to top of buttocks), and the final score ranges from 0-72, with higher scores reflecting more disease severity. Time to achieve at least 50% improvement in PASI from baseline was measured. |
| Time to Achieve PASI 75 | Baseline (Day 1 of Core Treatment Period) up to Month 4 | PASI correlates to the physician's assessment of psoriasis symptoms including redness of lesions, thickness of lesions, scaliness of lesions and extent of disease. Each parameter is graded from 0-4, 0 refers to no disease and 4 to severe involvement. The body is divided into 4 areas for scoring (head, arms, trunk to groin, legs to top of buttocks), and the final score ranges from 0-72, with higher scores reflecting more disease severity. Time to achieve at least 75% improvement in PASI from baseline was measured. |
| Time to Achieve PASI 90 | Baseline (Day 1 of Core Treatment Period) up to Month 4 | PASI correlates to the physician's assessment of psoriasis symptoms including redness of lesions, thickness of lesions, scaliness of lesions and extent of disease. Each parameter is graded from 0-4, 0 refers to no disease and 4 to severe involvement. The body is divided into 4 areas for scoring (head, arms, trunk to groin, legs to top of buttocks), and the final score ranges from 0-72, with higher scores reflecting more disease severity. Time to achieve at least 90% improvement in PASI from baseline was measured. |
| Time to Achieve PASI 100 | Baseline (Day 1 of Core Treatment Period) up to Month 13.5 | PASI correlates to the physician's assessment of psoriasis symptoms including redness of lesions, thickness of lesions, scaliness of lesions and extent of disease. Each parameter is graded from 0-4, 0 refers to no disease and 4 to severe involvement. The body is divided into 4 areas for scoring (head, arms, trunk to groin, legs to top of buttocks), and the final score ranges from 0-72, with higher scores reflecting more disease severity. Time to achieve at least 100% improvement in PASI from baseline was measured. |
| Number of Participants With Change in Physician's Global Assessment (PGA) From Baseline at Week 16 | Baseline (Day 1 of Core Treatment Period), Week 16 | PGA was assessed relative to baseline condition based on a scale ranged from 0 to 4, where 0 indicates clear condition (no signs of psoriasis, post-inflammatory hyperpigmentation may be present), 1 indicates Almost clear condition (normal to pink coloration of lesion, no thickening and no to minimal \[focal\] scaling), 2 indicates mild condition (pink to light red coloration, just detectable to mild thickening and predominantly fine scaling), 3 indicates moderate condition (dull bright red, clearly distinguishable erythema, clearly distinguishable to moderate thickening and moderate scaling), and 4 indicates severe condition (bright to deep dark red coloration, severe thickening with hard edges and severe/coarse scaling covering almost all or all lesions). |
| Number of Participants With Change in Physician's Global Assessment (PGA) From Baseline at Week 24 | Baseline (Day 1 of Extended Treatment Period), Week 24 | PGA was assessed relative to baseline condition based on a scale ranged from 0 to 4, where 0 indicates clear condition (no signs of psoriasis, post-inflammatory hyperpigmentation may be present), 1 indicates Almost clear condition (normal to pink coloration of lesion, no thickening and no to minimal \[focal\] scaling), 2 indicates mild condition (pink to light red coloration, just detectable to mild thickening and predominantly fine scaling), 3 indicates moderate condition (dull bright red, clearly distinguishable erythema, clearly distinguishable to moderate thickening and moderate scaling), and 4 indicates severe condition (bright to deep dark red coloration, severe thickening with hard edges and severe/coarse scaling covering almost all or all lesions). |
| Number of Participants With Change in Physician's Global Assessment (PGA) From Baseline at Week 52 | Baseline (Day 1 of Extended Treatment Period), Week 52 | PGA was assessed relative to baseline condition based on a scale ranged from 0 to 4, where 0 indicates clear condition (no signs of psoriasis, post-inflammatory hyperpigmentation may be present), 1 indicates Almost clear condition (normal to pink coloration of lesion, no thickening and no to minimal \[focal\] scaling), 2 indicates mild condition (pink to light red coloration, just detectable to mild thickening and predominantly fine scaling), 3 indicates moderate condition (dull bright red, clearly distinguishable erythema, clearly distinguishable to moderate thickening and moderate scaling), and 4 indicates severe condition (bright to deep dark red coloration, severe thickening with hard edges and severe/coarse scaling covering almost all or all lesions). |
| Number of Participants With Treatment Emergent Adverse Events (TEAEs), Serious TEAEs, TEAEs of Special Interest and TEAEs Leading to Death up to Week 16 | Baseline (Day 1 of Core Treatment Period) up to Week 16 | Adverse event(AE) was defined as any untoward medical occurrence in participants which does not necessarily have causal relationship with treatment. AE was any unfavorable and unintended sign(including abnormal laboratory finding), symptom/disease temporally associated with use of medicinal product, whether/not considered related to medicinal product. A serious adverse event(SAE) was AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial/prolonged inpatient hospitalization; congenital anomaly/birth defect or was otherwise considered medically important. Term TEAE is defined as AEs starting/worsening after first intake of the study drug. TEAEs included both Serious TEAEs and non-serious TEAEs. |
| Number of Participants With Treatment Emergent Adverse Events (TEAEs), Serious TEAEs, TEAEs of Special Interest and TEAEs Leading to Death up to Week 54 | Baseline (Day 1 of Extended Treatment Period) up to Week 54 | Adverse event(AE) was defined as any untoward medical occurrence in participants which does not necessarily have causal relationship with treatment. AE was any unfavorable and unintended sign(including abnormal laboratory finding), symptom/disease temporally associated with use of medicinal product, whether/not considered related to medicinal product. A serious adverse event(SAE) was AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial/prolonged inpatient hospitalization; congenital anomaly/birth defect or was otherwise considered medically important. Term TEAE is defined as AEs starting/worsening after first intake of the study drug. TEAEs included both Serious TEAEs and non-serious TEAEs. |
| Number of Participants With Clinically Meaningful Differences in Laboratory Values | Core Treatment Period: Baseline up to 16; Extended Treatment Period: Baseline up to Week 54 | Based on categories of low, normal, or high according to the laboratory normal ranges, there were no clinically meaningful differences across the treatment groups in the numbers of participants with shifts in Laboratory parameters including hematology, chemistry and urinalysis from normal at Core Baseline to either low or high during the overall treatment period. Clinical meaningful was determined by the investigator. |
| Number of Participants With Anti-nuclear Antibodies (ANA) and Anti-double-stranded Deoxyribonucleic Acid (Anti-dsDNA) Assessments at Week 16 | Week 16 | Number of participants ANA and anti-ds DNA values were reported. For ANA, positivity is defined as any participants with ANA titer greater than (\>) 1:160 and negativity is defined as ANA titer less than (\<) 1:160. For anti-ds DNA, positivity is defined as any participants with adsDNA \> 15 units per milliliter (U/mL), intermediate category is defined as value between 10 U/mL to 15 U/mL and negativity is defined as adsDNA \< 10 U/mL. |
| Number of Participants With Anti-nuclear Antibodies (ANA) and Anti-double-stranded Deoxyribonucleic Acid (Anti-dsDNA) Assessments at Week 24, 32, 40 and 52 | Week 24, 32, 40 and 52 | Number of participants ANA and anti-ds DNA values were reported. For ANA, positivity is defined as any participants with ANA titer greater than (\>) 1:160 and negativity is defined as ANA titer less than (\<) 1:160. For anti-ds DNA, positivity is defined as any participants with adsDNA \> 15 units per milliliter (U/mL), intermediate category is defined as value between 10 U/mL to 15 U/mL and negativity is defined as adsDNA \< 10 U/mL. |
| Percent Change From Baseline in PASI at Week 16 | Baseline (Day 1 of Core Treatment Period), Week 16 | PASI correlates to the physician's assessment of psoriasis symptoms including redness of lesions, thickness of lesions, scaliness of lesions and extent of disease. Each parameter is graded from 0-4, 0 refers to no disease and 4 to severe involvement. The body is divided into 4 areas for scoring (head, arms, trunk to groin, legs to top of buttocks), and the final score ranges from 0-72, with higher scores reflecting more disease severity. Percent change from Baseline in PASI score was reported. |
| Number of Participants With Clinically Significant Abnormalities in 12-Electrocardiogram (12-ECG) | Core Treatment Period: Baseline up to 16; Extended Treatment Period: Baseline up to Week 54 | Number of participants with clinically significant abnormalities in 12-ECG were reported. Clinical significance was determined by the investigator. |
| Dermatology Life Quality Index (DLQI) at Week 16 | Weeks 16 | The DLQI is a 10-item validated quality-of-life questionnaire that covers 6 domains: symptoms and feelings, daily activities, leisure, work and school, personal relationships, and treatment. The DLQI measures how much participant's skin problems has affected his life. Responses range from 0=Not at all to 3=Very much. The DLQI total score is the sum of individual 10 items and could range from 0 to 30 (higher score indicated greater negative impact on life). |
| Dermatology Life Quality Index (DLQI) at Week 24 and 52 | Week 24 and 52 | The DLQI is a 10-item validated quality-of-life questionnaire that covers 6 domains: symptoms and feelings, daily activities, leisure, work and school, personal relationships, and treatment. The DLQI measures how much participant's skin problems has affected his life. Responses range from 0=Not at all to 3=Very much. The DLQI total score is the sum of individual 10 items and could range from 0 to 30 (higher score indicated greater negative impact on life). |
| European Quality of Life 5-Dimensions and 5-Levels Questionnaire (EQ5D-5L) Descriptive Score at Week 16 | Week 16 | The EQ-5D-5L questionnaire assesses 5 dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 5 response options (no problems, slight problems, moderate problems, severe problems and extreme problems) that reflect increasing levels of difficulty. The participant was asked to indicate his/her current health state by selecting the most appropriate level in each of the 5 dimensions. The responses are converted into a single index value, with scores ranging from -0.594 to 1 (a higher score indicates better health state). |
| European Quality of Life 5-Dimensions and 5-Levels Questionnaire (EQ5D-5L) Descriptive Score at Week 24 and 52 | Week 24 and 52 | The EQ-5D-5L questionnaire assesses 5 dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 5 response options (no problems, slight problems, moderate problems, severe problems and extreme problems) that reflect increasing levels of difficulty. The participant was asked to indicate his/her current health state by selecting the most appropriate level in each of the 5 dimensions. The responses are converted into a single index value, with scores ranging from -0.594 to 1 (a higher score indicates better health state). |
| European Quality of Life 5-Dimensions and 5-Levels Questionnaire (EQ5D-5L) Based on Visual Analogue Scale (VAS) Score at Week 16 | Week 16 | The EQ-5D-5L questionnaire assesses 5 dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 5 response options (no problems, slight problems, moderate problems, severe problems and extreme problems) that reflect increasing levels of difficulty. The participant was asked to indicate his/her current health state by selecting the most appropriate level on a visual analog scale, where the participant was asked to rate current health status on a scale of 0 to 100, with 0 being the worst imaginable health state. |
| European Quality of Life 5-Dimensions and 5-Levels Questionnaire (EQ5D-5L) Based on VAS Score at Week 24 and 52 | Week 24 and 52 | The EQ-5D-5L questionnaire assesses 5 dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 5 response options (no problems, slight problems, moderate problems, severe problems and extreme problems) that reflect increasing levels of difficulty. The participant was asked to indicate his/her current health state by selecting the most appropriate level on a visual analog scale, where the participant was asked to rate current health status on a scale of 0 to 100, with 0 being the worst imaginable health state. |
| Health Assessment Questionnaire Disability Index (HAQ-DI) at Week 16 | Week 16 | HAQ-DI: participant-reported assessment of ability to perform tasks in 8 categories of daily living activities: dress/groom; arise; eat; walk; reach; grip; hygiene; and common activities over past week. Each item scored on 4-point scale from 0 to 3: 0=no difficulty; 1=some difficulty; 2=much difficulty; 3=unable to do. Overall score was computed as the sum of domain scores and divided by the number of domains answered. Total possible score range 0-3 where 0 = least difficulty and 3 = extreme difficulty. |
| Health Assessment Questionnaire Disability Index (HAQ-DI) at Week 24, and 52 | Week 24 and 52 | HAQ-DI: participant-reported assessment of ability to perform tasks in 8 categories of daily living activities: dress/groom; arise; eat; walk; reach; grip; hygiene; and common activities over past week. Each item scored on 4-point scale from 0 to 3: 0=no difficulty; 1=some difficulty; 2=much difficulty; 3=unable to do. Overall score was computed as the sum of domain scores and divided by the number of domains answered. Total possible score range 0-3 where 0 = least difficulty and 3 = extreme difficulty. |
| Patient Global Assessment for Joints on Visual Analog Scale (PJA-VAS) at Week 16 | Week 16 | Patient global assessment for joints was measured on a 100 millimeter (mm) VAS scale, where 0 = no pain and 100 = worst possible pain. |
| Patient Global Assessment for Joints on Visual Analog Scale (PJA-VAS) at Week 24 and 52 | Week 24 and 52 | Patient global assessment for joints was measured on a 100 millimeter (mm) VAS scale, where 0 = no pain and 100 = worst possible pain. |
| Number of Participants With Anti-Drug Antibodies (ADAs) and Neutralizing Antibodies (NAbs) to Adalimumab at Week 16 | Week 16 | Number of participants with treatment emergent Anti-Drug Antibodies (ADAs) and Neutralizing Antibodies (NAbs) to Adalimumab were reported from baseline to week 16. Data was collected using validated bioanalytical method. |
| Number of Participants With Anti-Drug Antibodies (ADAs) and Neutralizing Antibodies (NAbs) to Adalimumab at Week 24, 32, 40 and 52 | Week 24, 32, 40 and 52 | Number of participants With positive treatment emergent Anti-Drug Antibodies (ADAs) and positive Neutralizing Antibodies (NAbs) to Adalimumab were reported. Data was collected using validated bioanalytical method. |
| Anti-Drug Antibodies (ADAs) Titers for Adalimumab at Week 16 | Week 16 | Anti-Drug Antibodies (ADAs) Titers for adalimumab at week 16 was reported. Data was collected using validated bioanalytical method. |
| Anti-Drug Antibodies (ADAs) Titers for Adalimumab at Week 24, 32, 40 and 52 | Week 24, 32, 40 and 52 | Anti-Drug Antibodies (ADAs) Titers for adalimumab at Week 24, 32, 40 and 50 was reported. Data was collected using validated bioanalytical method. |
| Observed Serum Concentration at Week 16 | Week 16 | Observed serum concentrations at week 16 were reported. |
| Observed Serum Concentration at Week 24 and 52 | Week 24 and 52 | Observed serum concentrations at week 24 and 52 were reported. |
| Number of Participants With Clinically Meaningful Differences in Vital Signs | Core Treatment Period: Baseline up to 16; Extended Treatment Period: Baseline up to Week 54 | Number of participants with clinically meaningful abnormalities in vital signs were reported. Clinical meaningful was determined by the investigator. |
Countries
Bulgaria, Canada, Czechia, Estonia, France, Germany, Hungary, Mexico, Poland, Russia, United Kingdom, United States
Participant flow
Pre-assignment details
Participants were randomized to either MSB11022 or EU-Humira in Core Treatment Period till Week 16. Participants who achieved PASI50 at Week 16 entered Extension Period where participants in MSB11022 were continued to receive MSB11022 & participants in EU-Humira were re-randomized to receive either MSB11022 or EU-Humira for additional 37 weeks.
Participants by arm
| Arm | Count |
|---|---|
| MSB11022 (Core Treatment Period) Participants received MSB11022 subcutaneously at an initial dose of 80 milligram (mg) on Day 1 of Week 1 followed by 40 mg every other week starting at Week 2 up to and including Week 14 in Core Treatment Period. | 222 |
| EU-Humira Participants received EU-Humira subcutaneously at an initial dose of 80 mg on Day 1 of Week 1 followed by 40 mg every other week starting at Week 2 up to and including Week 14 in Core Treatment Period. | 221 |
| Total | 443 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 | FG004 |
|---|---|---|---|---|---|---|
| Core Treatment Period (Week 1 to 16) | Adverse Event | 2 | 9 | 0 | 0 | 0 |
| Core Treatment Period (Week 1 to 16) | Lack of Efficacy | 0 | 2 | 0 | 0 | 0 |
| Core Treatment Period (Week 1 to 16) | Lost to Follow-up | 1 | 2 | 0 | 0 | 0 |
| Core Treatment Period (Week 1 to 16) | Other un-specified | 1 | 0 | 0 | 0 | 0 |
| Core Treatment Period (Week 1 to 16) | Protocol Violation | 3 | 1 | 0 | 0 | 0 |
| Core Treatment Period (Week 1 to 16) | Randomized, not treated | 1 | 1 | 0 | 0 | 0 |
| Core Treatment Period (Week 1 to 16) | Withdrawal by Subject | 1 | 4 | 0 | 0 | 0 |
| Extended Treatment Period(Week 16 to 52) | Adverse Event | 0 | 0 | 8 | 6 | 4 |
| Extended Treatment Period(Week 16 to 52) | Lack of Efficacy | 0 | 0 | 4 | 2 | 2 |
| Extended Treatment Period(Week 16 to 52) | Lost to Follow-up | 0 | 0 | 0 | 1 | 1 |
| Extended Treatment Period(Week 16 to 52) | Other un-specified | 0 | 0 | 1 | 0 | 1 |
| Extended Treatment Period(Week 16 to 52) | Protocol Violation | 0 | 0 | 2 | 0 | 1 |
| Extended Treatment Period(Week 16 to 52) | Withdrawal by Subject | 0 | 0 | 3 | 2 | 2 |
Baseline characteristics
| Characteristic | EU-Humira | Total | MSB11022 (Core Treatment Period) |
|---|---|---|---|
| Age, Continuous | 42.7 years STANDARD_DEVIATION 12 | 43.6 years STANDARD_DEVIATION 12.5 | 44.5 years STANDARD_DEVIATION 12.8 |
| Ethnicity Hispanic or Latino | 23 Participants | 46 Participants | 23 Participants |
| Ethnicity Missing | 2 Participants | 2 Participants | 0 Participants |
| Ethnicity Not Hispanic or Latino | 196 Participants | 395 Participants | 199 Participants |
| Race American Indian or Alaska Native | 8 Participants | 18 Participants | 10 Participants |
| Race Asian | 9 Participants | 14 Participants | 5 Participants |
| Race Black or African American | 1 Participants | 3 Participants | 2 Participants |
| Race Missing/Not collected at this site | 2 Participants | 2 Participants | 0 Participants |
| Race Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race Other | 1 Participants | 1 Participants | 0 Participants |
| Race White | 200 Participants | 405 Participants | 205 Participants |
| Sex: Female, Male Female | 73 Participants | 148 Participants | 75 Participants |
| Sex: Female, Male Male | 148 Participants | 295 Participants | 147 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk |
|---|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 221 | 0 / 220 | 0 / 213 | 1 / 101 | 0 / 101 |
| other Total, other adverse events | 30 / 221 | 34 / 220 | 59 / 213 | 32 / 101 | 25 / 101 |
| serious Total, serious adverse events | 8 / 221 | 6 / 220 | 12 / 213 | 3 / 101 | 4 / 101 |
Outcome results
Primary
Percentage of Participants Who Achieved Psoriasis Area and Severity Index 75 (PASI 75) at Week 16
PASI correlates to the physician's assessment of psoriasis symptoms including redness of lesions, thickness of lesions, scaliness of lesions and extent of disease. Each parameter is graded from 0-4, 0 refers to no disease and 4 to severe involvement. The body is divided into 4 areas for scoring (head, arms, trunk to groin, legs to top of buttocks), and the final score ranges from 0-72 with higher scores reflecting more disease severity. The PASI-75 response is defined as the percentage of participants who achieved at least a 75% improvement in PASI score from Baseline.
Time frame: Week 16
Population: The per-protocol (PP) Analysis Set included all randomized and treated participants who did not have any major protocol deviations during the Core Treatment Period with respect to factors likely to affect the efficacy of treatment.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| MSB11022 (Core Treatment Period) | Percentage of Participants Who Achieved Psoriasis Area and Severity Index 75 (PASI 75) at Week 16 | 89.7 Percentage of Participants |
| EU-Humira | Percentage of Participants Who Achieved Psoriasis Area and Severity Index 75 (PASI 75) at Week 16 | 91.6 Percentage of Participants |
95% CI: [-7.82, 4.07]
Secondary
Anti-Drug Antibodies (ADAs) Titers for Adalimumab at Week 16
Anti-Drug Antibodies (ADAs) Titers for adalimumab at week 16 was reported. Data was collected using validated bioanalytical method.
Time frame: Week 16
Population: SAF analysis set was used. Here Number of Participants analyzed signifies those who were evaluable for this outcome measure.
| Arm | Measure | Value (MEDIAN) | Dispersion |
|---|---|---|---|
| MSB11022 (Core Treatment Period) | Anti-Drug Antibodies (ADAs) Titers for Adalimumab at Week 16 | 8.0 Titers | Full Range 1 |
| EU-Humira | Anti-Drug Antibodies (ADAs) Titers for Adalimumab at Week 16 | 8.0 Titers | Full Range 1 |
Secondary
Anti-Drug Antibodies (ADAs) Titers for Adalimumab at Week 24, 32, 40 and 52
Anti-Drug Antibodies (ADAs) Titers for adalimumab at Week 24, 32, 40 and 50 was reported. Data was collected using validated bioanalytical method.
Time frame: Week 24, 32, 40 and 52
Population: ETP-SAF analysis set was used. Here Number analyzed signifies those participants who were evaluable for this outcome measure at specified category.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| MSB11022 (Core Treatment Period) | Anti-Drug Antibodies (ADAs) Titers for Adalimumab at Week 24, 32, 40 and 52 | Week 24 | 16.0 Titers |
| MSB11022 (Core Treatment Period) | Anti-Drug Antibodies (ADAs) Titers for Adalimumab at Week 24, 32, 40 and 52 | Week 32 | 16.0 Titers |
| MSB11022 (Core Treatment Period) | Anti-Drug Antibodies (ADAs) Titers for Adalimumab at Week 24, 32, 40 and 52 | Week 40 | 16.0 Titers |
| MSB11022 (Core Treatment Period) | Anti-Drug Antibodies (ADAs) Titers for Adalimumab at Week 24, 32, 40 and 52 | Week 52 | 8.0 Titers |
| EU-Humira | Anti-Drug Antibodies (ADAs) Titers for Adalimumab at Week 24, 32, 40 and 52 | Week 52 | 16.0 Titers |
| EU-Humira | Anti-Drug Antibodies (ADAs) Titers for Adalimumab at Week 24, 32, 40 and 52 | Week 24 | 16.0 Titers |
| EU-Humira | Anti-Drug Antibodies (ADAs) Titers for Adalimumab at Week 24, 32, 40 and 52 | Week 40 | 16.0 Titers |
| EU-Humira | Anti-Drug Antibodies (ADAs) Titers for Adalimumab at Week 24, 32, 40 and 52 | Week 32 | 16.0 Titers |
| EU-Humira/MSB11022 | Anti-Drug Antibodies (ADAs) Titers for Adalimumab at Week 24, 32, 40 and 52 | Week 52 | 8.0 Titers |
| EU-Humira/MSB11022 | Anti-Drug Antibodies (ADAs) Titers for Adalimumab at Week 24, 32, 40 and 52 | Week 32 | 16.0 Titers |
| EU-Humira/MSB11022 | Anti-Drug Antibodies (ADAs) Titers for Adalimumab at Week 24, 32, 40 and 52 | Week 40 | 16.0 Titers |
| EU-Humira/MSB11022 | Anti-Drug Antibodies (ADAs) Titers for Adalimumab at Week 24, 32, 40 and 52 | Week 24 | 16.0 Titers |
Secondary
Dermatology Life Quality Index (DLQI) at Week 16
The DLQI is a 10-item validated quality-of-life questionnaire that covers 6 domains: symptoms and feelings, daily activities, leisure, work and school, personal relationships, and treatment. The DLQI measures how much participant's skin problems has affected his life. Responses range from 0=Not at all to 3=Very much. The DLQI total score is the sum of individual 10 items and could range from 0 to 30 (higher score indicated greater negative impact on life).
Time frame: Weeks 16
Population: PP analysis set was used.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| MSB11022 (Core Treatment Period) | Dermatology Life Quality Index (DLQI) at Week 16 | 2.4 Units on a scale | Standard Deviation 3.2 |
| EU-Humira | Dermatology Life Quality Index (DLQI) at Week 16 | 2.5 Units on a scale | Standard Deviation 3.7 |
Secondary
Dermatology Life Quality Index (DLQI) at Week 24 and 52
The DLQI is a 10-item validated quality-of-life questionnaire that covers 6 domains: symptoms and feelings, daily activities, leisure, work and school, personal relationships, and treatment. The DLQI measures how much participant's skin problems has affected his life. Responses range from 0=Not at all to 3=Very much. The DLQI total score is the sum of individual 10 items and could range from 0 to 30 (higher score indicated greater negative impact on life).
Time frame: Week 24 and 52
Population: ETP-PP analysis set was used. Here Number analyzed signifies number of participants who were evaluable for this outcome measure at specified category.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| MSB11022 (Core Treatment Period) | Dermatology Life Quality Index (DLQI) at Week 24 and 52 | Week 24 | 2.5 Units on a scale | Standard Deviation 4.1 |
| MSB11022 (Core Treatment Period) | Dermatology Life Quality Index (DLQI) at Week 24 and 52 | Week 52 | 3.0 Units on a scale | Standard Deviation 4.7 |
| EU-Humira | Dermatology Life Quality Index (DLQI) at Week 24 and 52 | Week 52 | 2.1 Units on a scale | Standard Deviation 3.5 |
| EU-Humira | Dermatology Life Quality Index (DLQI) at Week 24 and 52 | Week 24 | 2.3 Units on a scale | Standard Deviation 4 |
| EU-Humira/MSB11022 | Dermatology Life Quality Index (DLQI) at Week 24 and 52 | Week 24 | 2.3 Units on a scale | Standard Deviation 3.9 |
| EU-Humira/MSB11022 | Dermatology Life Quality Index (DLQI) at Week 24 and 52 | Week 52 | 2.7 Units on a scale | Standard Deviation 4 |
Secondary
European Quality of Life 5-Dimensions and 5-Levels Questionnaire (EQ5D-5L) Based on VAS Score at Week 24 and 52
The EQ-5D-5L questionnaire assesses 5 dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 5 response options (no problems, slight problems, moderate problems, severe problems and extreme problems) that reflect increasing levels of difficulty. The participant was asked to indicate his/her current health state by selecting the most appropriate level on a visual analog scale, where the participant was asked to rate current health status on a scale of 0 to 100, with 0 being the worst imaginable health state.
Time frame: Week 24 and 52
Population: ETP-PP analysis set was used. Here Number analyzed signifies those participants who were evaluable for this outcome measure at specified category.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| MSB11022 (Core Treatment Period) | European Quality of Life 5-Dimensions and 5-Levels Questionnaire (EQ5D-5L) Based on VAS Score at Week 24 and 52 | Week 24 | 83.2 Units on a scale | Standard Deviation 14.2 |
| MSB11022 (Core Treatment Period) | European Quality of Life 5-Dimensions and 5-Levels Questionnaire (EQ5D-5L) Based on VAS Score at Week 24 and 52 | Week 52 | 83.5 Units on a scale | Standard Deviation 15.5 |
| EU-Humira | European Quality of Life 5-Dimensions and 5-Levels Questionnaire (EQ5D-5L) Based on VAS Score at Week 24 and 52 | Week 24 | 84.2 Units on a scale | Standard Deviation 13.7 |
| EU-Humira | European Quality of Life 5-Dimensions and 5-Levels Questionnaire (EQ5D-5L) Based on VAS Score at Week 24 and 52 | Week 52 | 85.1 Units on a scale | Standard Deviation 13.2 |
| EU-Humira/MSB11022 | European Quality of Life 5-Dimensions and 5-Levels Questionnaire (EQ5D-5L) Based on VAS Score at Week 24 and 52 | Week 24 | 84.3 Units on a scale | Standard Deviation 13.9 |
| EU-Humira/MSB11022 | European Quality of Life 5-Dimensions and 5-Levels Questionnaire (EQ5D-5L) Based on VAS Score at Week 24 and 52 | Week 52 | 82.1 Units on a scale | Standard Deviation 16.1 |
Secondary
European Quality of Life 5-Dimensions and 5-Levels Questionnaire (EQ5D-5L) Based on Visual Analogue Scale (VAS) Score at Week 16
The EQ-5D-5L questionnaire assesses 5 dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 5 response options (no problems, slight problems, moderate problems, severe problems and extreme problems) that reflect increasing levels of difficulty. The participant was asked to indicate his/her current health state by selecting the most appropriate level on a visual analog scale, where the participant was asked to rate current health status on a scale of 0 to 100, with 0 being the worst imaginable health state.
Time frame: Week 16
Population: PP analysis set was used. Here Number of participants analyzed signifies those participants who were evaluable for this outcome measure.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| MSB11022 (Core Treatment Period) | European Quality of Life 5-Dimensions and 5-Levels Questionnaire (EQ5D-5L) Based on Visual Analogue Scale (VAS) Score at Week 16 | 81.9 Units on a scale | Standard Deviation 13.9 |
| EU-Humira | European Quality of Life 5-Dimensions and 5-Levels Questionnaire (EQ5D-5L) Based on Visual Analogue Scale (VAS) Score at Week 16 | 83.1 Units on a scale | Standard Deviation 15 |
Secondary
European Quality of Life 5-Dimensions and 5-Levels Questionnaire (EQ5D-5L) Descriptive Score at Week 16
The EQ-5D-5L questionnaire assesses 5 dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 5 response options (no problems, slight problems, moderate problems, severe problems and extreme problems) that reflect increasing levels of difficulty. The participant was asked to indicate his/her current health state by selecting the most appropriate level in each of the 5 dimensions. The responses are converted into a single index value, with scores ranging from -0.594 to 1 (a higher score indicates better health state).
Time frame: Week 16
Population: PP analysis set was used. Here Number of participants analyzed signifies those participants who were evaluable for this outcome measure.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| MSB11022 (Core Treatment Period) | European Quality of Life 5-Dimensions and 5-Levels Questionnaire (EQ5D-5L) Descriptive Score at Week 16 | 0.9 Units on a scale | Standard Deviation 0.1 |
| EU-Humira | European Quality of Life 5-Dimensions and 5-Levels Questionnaire (EQ5D-5L) Descriptive Score at Week 16 | 0.9 Units on a scale | Standard Deviation 0.1 |
Secondary
European Quality of Life 5-Dimensions and 5-Levels Questionnaire (EQ5D-5L) Descriptive Score at Week 24 and 52
The EQ-5D-5L questionnaire assesses 5 dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 5 response options (no problems, slight problems, moderate problems, severe problems and extreme problems) that reflect increasing levels of difficulty. The participant was asked to indicate his/her current health state by selecting the most appropriate level in each of the 5 dimensions. The responses are converted into a single index value, with scores ranging from -0.594 to 1 (a higher score indicates better health state).
Time frame: Week 24 and 52
Population: ETP-PP analysis set was used. Here Number analyzed signifies those participants who were evaluable for this outcome measure at specified category.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| MSB11022 (Core Treatment Period) | European Quality of Life 5-Dimensions and 5-Levels Questionnaire (EQ5D-5L) Descriptive Score at Week 24 and 52 | Week 24 | 0.8 Units on a scale | Standard Deviation 0.1 |
| MSB11022 (Core Treatment Period) | European Quality of Life 5-Dimensions and 5-Levels Questionnaire (EQ5D-5L) Descriptive Score at Week 24 and 52 | Week 52 | 0.9 Units on a scale | Standard Deviation 0.1 |
| EU-Humira | European Quality of Life 5-Dimensions and 5-Levels Questionnaire (EQ5D-5L) Descriptive Score at Week 24 and 52 | Week 24 | 0.9 Units on a scale | Standard Deviation 0.1 |
| EU-Humira | European Quality of Life 5-Dimensions and 5-Levels Questionnaire (EQ5D-5L) Descriptive Score at Week 24 and 52 | Week 52 | 0.9 Units on a scale | Standard Deviation 0.1 |
| EU-Humira/MSB11022 | European Quality of Life 5-Dimensions and 5-Levels Questionnaire (EQ5D-5L) Descriptive Score at Week 24 and 52 | Week 24 | 0.9 Units on a scale | Standard Deviation 0.1 |
| EU-Humira/MSB11022 | European Quality of Life 5-Dimensions and 5-Levels Questionnaire (EQ5D-5L) Descriptive Score at Week 24 and 52 | Week 52 | 0.8 Units on a scale | Standard Deviation 0.1 |
Secondary
Health Assessment Questionnaire Disability Index (HAQ-DI) at Week 16
HAQ-DI: participant-reported assessment of ability to perform tasks in 8 categories of daily living activities: dress/groom; arise; eat; walk; reach; grip; hygiene; and common activities over past week. Each item scored on 4-point scale from 0 to 3: 0=no difficulty; 1=some difficulty; 2=much difficulty; 3=unable to do. Overall score was computed as the sum of domain scores and divided by the number of domains answered. Total possible score range 0-3 where 0 = least difficulty and 3 = extreme difficulty.
Time frame: Week 16
Population: PP analysis set was used. Here Number of participants analyzed signifies those participants who were evaluable for this outcome measure.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| MSB11022 (Core Treatment Period) | Health Assessment Questionnaire Disability Index (HAQ-DI) at Week 16 | 0.3 Units on a scale | Standard Deviation 0.4 |
| EU-Humira | Health Assessment Questionnaire Disability Index (HAQ-DI) at Week 16 | 0.3 Units on a scale | Standard Deviation 0.4 |
Secondary
Health Assessment Questionnaire Disability Index (HAQ-DI) at Week 24, and 52
HAQ-DI: participant-reported assessment of ability to perform tasks in 8 categories of daily living activities: dress/groom; arise; eat; walk; reach; grip; hygiene; and common activities over past week. Each item scored on 4-point scale from 0 to 3: 0=no difficulty; 1=some difficulty; 2=much difficulty; 3=unable to do. Overall score was computed as the sum of domain scores and divided by the number of domains answered. Total possible score range 0-3 where 0 = least difficulty and 3 = extreme difficulty.
Time frame: Week 24 and 52
Population: ETP-PP analysis set was used. Here Number analyzed signifies those participants who were evaluable for this outcome measure at specified category.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| MSB11022 (Core Treatment Period) | Health Assessment Questionnaire Disability Index (HAQ-DI) at Week 24, and 52 | Week 24 | 0.3 Units on a scale | Standard Deviation 0.4 |
| MSB11022 (Core Treatment Period) | Health Assessment Questionnaire Disability Index (HAQ-DI) at Week 24, and 52 | Week 52 | 0.3 Units on a scale | Standard Deviation 0.4 |
| EU-Humira | Health Assessment Questionnaire Disability Index (HAQ-DI) at Week 24, and 52 | Week 24 | 0.2 Units on a scale | Standard Deviation 0.5 |
| EU-Humira | Health Assessment Questionnaire Disability Index (HAQ-DI) at Week 24, and 52 | Week 52 | 0.1 Units on a scale | Standard Deviation 0.2 |
| EU-Humira/MSB11022 | Health Assessment Questionnaire Disability Index (HAQ-DI) at Week 24, and 52 | Week 24 | 0.4 Units on a scale | Standard Deviation 0.3 |
| EU-Humira/MSB11022 | Health Assessment Questionnaire Disability Index (HAQ-DI) at Week 24, and 52 | Week 52 | 0.5 Units on a scale | Standard Deviation 0.3 |
Secondary
Number of Participants With Anti-Drug Antibodies (ADAs) and Neutralizing Antibodies (NAbs) to Adalimumab at Week 16
Number of participants with treatment emergent Anti-Drug Antibodies (ADAs) and Neutralizing Antibodies (NAbs) to Adalimumab were reported from baseline to week 16. Data was collected using validated bioanalytical method.
Time frame: Week 16
Population: SAF analysis set was used. Here Number of participants analyzed signifies those who were evaluable for this outcome measure and Number analyzed signifies those participants who were evaluable for this outcome measure at specified category.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| MSB11022 (Core Treatment Period) | Number of Participants With Anti-Drug Antibodies (ADAs) and Neutralizing Antibodies (NAbs) to Adalimumab at Week 16 | Participants with ADAs | 186 Participants |
| MSB11022 (Core Treatment Period) | Number of Participants With Anti-Drug Antibodies (ADAs) and Neutralizing Antibodies (NAbs) to Adalimumab at Week 16 | Participants with Neutralizing Abs | 70 Participants |
| EU-Humira | Number of Participants With Anti-Drug Antibodies (ADAs) and Neutralizing Antibodies (NAbs) to Adalimumab at Week 16 | Participants with ADAs | 179 Participants |
| EU-Humira | Number of Participants With Anti-Drug Antibodies (ADAs) and Neutralizing Antibodies (NAbs) to Adalimumab at Week 16 | Participants with Neutralizing Abs | 70 Participants |
Secondary
Number of Participants With Anti-Drug Antibodies (ADAs) and Neutralizing Antibodies (NAbs) to Adalimumab at Week 24, 32, 40 and 52
Number of participants With positive treatment emergent Anti-Drug Antibodies (ADAs) and positive Neutralizing Antibodies (NAbs) to Adalimumab were reported. Data was collected using validated bioanalytical method.
Time frame: Week 24, 32, 40 and 52
Population: ETP-SAF analysis set was used. Here Number analyzed signifies participants who were evaluable for this outcome measure at specified category.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| MSB11022 (Core Treatment Period) | Number of Participants With Anti-Drug Antibodies (ADAs) and Neutralizing Antibodies (NAbs) to Adalimumab at Week 24, 32, 40 and 52 | Week 24: ADAs | 185 Participants |
| MSB11022 (Core Treatment Period) | Number of Participants With Anti-Drug Antibodies (ADAs) and Neutralizing Antibodies (NAbs) to Adalimumab at Week 24, 32, 40 and 52 | Week 32: ADAs | 170 Participants |
| MSB11022 (Core Treatment Period) | Number of Participants With Anti-Drug Antibodies (ADAs) and Neutralizing Antibodies (NAbs) to Adalimumab at Week 24, 32, 40 and 52 | Week 40: ADAs | 161 Participants |
| MSB11022 (Core Treatment Period) | Number of Participants With Anti-Drug Antibodies (ADAs) and Neutralizing Antibodies (NAbs) to Adalimumab at Week 24, 32, 40 and 52 | Week 52: ADAs | 162 Participants |
| MSB11022 (Core Treatment Period) | Number of Participants With Anti-Drug Antibodies (ADAs) and Neutralizing Antibodies (NAbs) to Adalimumab at Week 24, 32, 40 and 52 | Week 24: NAb | 78 Participants |
| MSB11022 (Core Treatment Period) | Number of Participants With Anti-Drug Antibodies (ADAs) and Neutralizing Antibodies (NAbs) to Adalimumab at Week 24, 32, 40 and 52 | Week 32: NAb | 67 Participants |
| MSB11022 (Core Treatment Period) | Number of Participants With Anti-Drug Antibodies (ADAs) and Neutralizing Antibodies (NAbs) to Adalimumab at Week 24, 32, 40 and 52 | Week 40: NAb | 70 Participants |
| MSB11022 (Core Treatment Period) | Number of Participants With Anti-Drug Antibodies (ADAs) and Neutralizing Antibodies (NAbs) to Adalimumab at Week 24, 32, 40 and 52 | Week 52: NAb | 63 Participants |
| EU-Humira | Number of Participants With Anti-Drug Antibodies (ADAs) and Neutralizing Antibodies (NAbs) to Adalimumab at Week 24, 32, 40 and 52 | Week 40: ADAs | 72 Participants |
| EU-Humira | Number of Participants With Anti-Drug Antibodies (ADAs) and Neutralizing Antibodies (NAbs) to Adalimumab at Week 24, 32, 40 and 52 | Week 40: NAb | 29 Participants |
| EU-Humira | Number of Participants With Anti-Drug Antibodies (ADAs) and Neutralizing Antibodies (NAbs) to Adalimumab at Week 24, 32, 40 and 52 | Week 52: ADAs | 68 Participants |
| EU-Humira | Number of Participants With Anti-Drug Antibodies (ADAs) and Neutralizing Antibodies (NAbs) to Adalimumab at Week 24, 32, 40 and 52 | Week 24: NAb | 42 Participants |
| EU-Humira | Number of Participants With Anti-Drug Antibodies (ADAs) and Neutralizing Antibodies (NAbs) to Adalimumab at Week 24, 32, 40 and 52 | Week 32: NAb | 30 Participants |
| EU-Humira | Number of Participants With Anti-Drug Antibodies (ADAs) and Neutralizing Antibodies (NAbs) to Adalimumab at Week 24, 32, 40 and 52 | Week 24: ADAs | 89 Participants |
| EU-Humira | Number of Participants With Anti-Drug Antibodies (ADAs) and Neutralizing Antibodies (NAbs) to Adalimumab at Week 24, 32, 40 and 52 | Week 32: ADAs | 78 Participants |
| EU-Humira | Number of Participants With Anti-Drug Antibodies (ADAs) and Neutralizing Antibodies (NAbs) to Adalimumab at Week 24, 32, 40 and 52 | Week 52: NAb | 29 Participants |
| EU-Humira/MSB11022 | Number of Participants With Anti-Drug Antibodies (ADAs) and Neutralizing Antibodies (NAbs) to Adalimumab at Week 24, 32, 40 and 52 | Week 40: ADAs | 80 Participants |
| EU-Humira/MSB11022 | Number of Participants With Anti-Drug Antibodies (ADAs) and Neutralizing Antibodies (NAbs) to Adalimumab at Week 24, 32, 40 and 52 | Week 32: ADAs | 85 Participants |
| EU-Humira/MSB11022 | Number of Participants With Anti-Drug Antibodies (ADAs) and Neutralizing Antibodies (NAbs) to Adalimumab at Week 24, 32, 40 and 52 | Week 24: ADAs | 90 Participants |
| EU-Humira/MSB11022 | Number of Participants With Anti-Drug Antibodies (ADAs) and Neutralizing Antibodies (NAbs) to Adalimumab at Week 24, 32, 40 and 52 | Week 52: ADAs | 77 Participants |
| EU-Humira/MSB11022 | Number of Participants With Anti-Drug Antibodies (ADAs) and Neutralizing Antibodies (NAbs) to Adalimumab at Week 24, 32, 40 and 52 | Week 40: NAb | 28 Participants |
| EU-Humira/MSB11022 | Number of Participants With Anti-Drug Antibodies (ADAs) and Neutralizing Antibodies (NAbs) to Adalimumab at Week 24, 32, 40 and 52 | Week 32: NAb | 32 Participants |
| EU-Humira/MSB11022 | Number of Participants With Anti-Drug Antibodies (ADAs) and Neutralizing Antibodies (NAbs) to Adalimumab at Week 24, 32, 40 and 52 | Week 24: NAb | 39 Participants |
| EU-Humira/MSB11022 | Number of Participants With Anti-Drug Antibodies (ADAs) and Neutralizing Antibodies (NAbs) to Adalimumab at Week 24, 32, 40 and 52 | Week 52: NAb | 30 Participants |
Secondary
Number of Participants With Anti-nuclear Antibodies (ANA) and Anti-double-stranded Deoxyribonucleic Acid (Anti-dsDNA) Assessments at Week 16
Number of participants ANA and anti-ds DNA values were reported. For ANA, positivity is defined as any participants with ANA titer greater than (\>) 1:160 and negativity is defined as ANA titer less than (\<) 1:160. For anti-ds DNA, positivity is defined as any participants with adsDNA \> 15 units per milliliter (U/mL), intermediate category is defined as value between 10 U/mL to 15 U/mL and negativity is defined as adsDNA \< 10 U/mL.
Time frame: Week 16
Population: Safety analysis set was used.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| MSB11022 (Core Treatment Period) | Number of Participants With Anti-nuclear Antibodies (ANA) and Anti-double-stranded Deoxyribonucleic Acid (Anti-dsDNA) Assessments at Week 16 | Participants with Positive ANA values | 6 Participants |
| MSB11022 (Core Treatment Period) | Number of Participants With Anti-nuclear Antibodies (ANA) and Anti-double-stranded Deoxyribonucleic Acid (Anti-dsDNA) Assessments at Week 16 | Participants with Intermediate anti-ds DNA values | 4 Participants |
| MSB11022 (Core Treatment Period) | Number of Participants With Anti-nuclear Antibodies (ANA) and Anti-double-stranded Deoxyribonucleic Acid (Anti-dsDNA) Assessments at Week 16 | Participants with Negative anti-ds DNA values | 201 Participants |
| MSB11022 (Core Treatment Period) | Number of Participants With Anti-nuclear Antibodies (ANA) and Anti-double-stranded Deoxyribonucleic Acid (Anti-dsDNA) Assessments at Week 16 | Participants with Positive anti-ds DNA values | 4 Participants |
| MSB11022 (Core Treatment Period) | Number of Participants With Anti-nuclear Antibodies (ANA) and Anti-double-stranded Deoxyribonucleic Acid (Anti-dsDNA) Assessments at Week 16 | Participants with Negative ANA values | 205 Participants |
| EU-Humira | Number of Participants With Anti-nuclear Antibodies (ANA) and Anti-double-stranded Deoxyribonucleic Acid (Anti-dsDNA) Assessments at Week 16 | Participants with Positive anti-ds DNA values | 6 Participants |
| EU-Humira | Number of Participants With Anti-nuclear Antibodies (ANA) and Anti-double-stranded Deoxyribonucleic Acid (Anti-dsDNA) Assessments at Week 16 | Participants with Negative ANA values | 190 Participants |
| EU-Humira | Number of Participants With Anti-nuclear Antibodies (ANA) and Anti-double-stranded Deoxyribonucleic Acid (Anti-dsDNA) Assessments at Week 16 | Participants with Positive ANA values | 10 Participants |
| EU-Humira | Number of Participants With Anti-nuclear Antibodies (ANA) and Anti-double-stranded Deoxyribonucleic Acid (Anti-dsDNA) Assessments at Week 16 | Participants with Negative anti-ds DNA values | 186 Participants |
| EU-Humira | Number of Participants With Anti-nuclear Antibodies (ANA) and Anti-double-stranded Deoxyribonucleic Acid (Anti-dsDNA) Assessments at Week 16 | Participants with Intermediate anti-ds DNA values | 5 Participants |
Secondary
Number of Participants With Anti-nuclear Antibodies (ANA) and Anti-double-stranded Deoxyribonucleic Acid (Anti-dsDNA) Assessments at Week 24, 32, 40 and 52
Number of participants ANA and anti-ds DNA values were reported. For ANA, positivity is defined as any participants with ANA titer greater than (\>) 1:160 and negativity is defined as ANA titer less than (\<) 1:160. For anti-ds DNA, positivity is defined as any participants with adsDNA \> 15 units per milliliter (U/mL), intermediate category is defined as value between 10 U/mL to 15 U/mL and negativity is defined as adsDNA \< 10 U/mL.
Time frame: Week 24, 32, 40 and 52
Population: ETP-SAF included all re-randomized participants who received at least 1 dose of MSB11022 or EU-approved Humira in ETP. Here Number of participants analyzed signifies those participants who were evaluable for this outcome measure \& Number analyzed signifies those participants who were evaluable for this outcome measure for specified categories.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| MSB11022 (Core Treatment Period) | Number of Participants With Anti-nuclear Antibodies (ANA) and Anti-double-stranded Deoxyribonucleic Acid (Anti-dsDNA) Assessments at Week 24, 32, 40 and 52 | Week 40: Positive anti-dsDNA | 10 Participants |
| MSB11022 (Core Treatment Period) | Number of Participants With Anti-nuclear Antibodies (ANA) and Anti-double-stranded Deoxyribonucleic Acid (Anti-dsDNA) Assessments at Week 24, 32, 40 and 52 | Week 52: Positive ANA | 8 Participants |
| MSB11022 (Core Treatment Period) | Number of Participants With Anti-nuclear Antibodies (ANA) and Anti-double-stranded Deoxyribonucleic Acid (Anti-dsDNA) Assessments at Week 24, 32, 40 and 52 | Week 24: Negative ANA | 188 Participants |
| MSB11022 (Core Treatment Period) | Number of Participants With Anti-nuclear Antibodies (ANA) and Anti-double-stranded Deoxyribonucleic Acid (Anti-dsDNA) Assessments at Week 24, 32, 40 and 52 | Week 32: Positive anti-dsDNA | 8 Participants |
| MSB11022 (Core Treatment Period) | Number of Participants With Anti-nuclear Antibodies (ANA) and Anti-double-stranded Deoxyribonucleic Acid (Anti-dsDNA) Assessments at Week 24, 32, 40 and 52 | Week 24: Negative anti-dsDNA | 191 Participants |
| MSB11022 (Core Treatment Period) | Number of Participants With Anti-nuclear Antibodies (ANA) and Anti-double-stranded Deoxyribonucleic Acid (Anti-dsDNA) Assessments at Week 24, 32, 40 and 52 | Week 52: Negative ANA | 185 Participants |
| MSB11022 (Core Treatment Period) | Number of Participants With Anti-nuclear Antibodies (ANA) and Anti-double-stranded Deoxyribonucleic Acid (Anti-dsDNA) Assessments at Week 24, 32, 40 and 52 | Week 24: Positive anti-dsDNA | 8 Participants |
| MSB11022 (Core Treatment Period) | Number of Participants With Anti-nuclear Antibodies (ANA) and Anti-double-stranded Deoxyribonucleic Acid (Anti-dsDNA) Assessments at Week 24, 32, 40 and 52 | Week 32: Negative anti-dsDNA | 184 Participants |
| MSB11022 (Core Treatment Period) | Number of Participants With Anti-nuclear Antibodies (ANA) and Anti-double-stranded Deoxyribonucleic Acid (Anti-dsDNA) Assessments at Week 24, 32, 40 and 52 | Week 52: Intermediate anti-dsDNA | 8 Participants |
| MSB11022 (Core Treatment Period) | Number of Participants With Anti-nuclear Antibodies (ANA) and Anti-double-stranded Deoxyribonucleic Acid (Anti-dsDNA) Assessments at Week 24, 32, 40 and 52 | Week 52: Negative anti-dsDNA | 173 Participants |
| MSB11022 (Core Treatment Period) | Number of Participants With Anti-nuclear Antibodies (ANA) and Anti-double-stranded Deoxyribonucleic Acid (Anti-dsDNA) Assessments at Week 24, 32, 40 and 52 | Week 40: Negative anti-dsDNA | 179 Participants |
| MSB11022 (Core Treatment Period) | Number of Participants With Anti-nuclear Antibodies (ANA) and Anti-double-stranded Deoxyribonucleic Acid (Anti-dsDNA) Assessments at Week 24, 32, 40 and 52 | Week 32: Intermediate anti-dsDNA | 7 Participants |
| MSB11022 (Core Treatment Period) | Number of Participants With Anti-nuclear Antibodies (ANA) and Anti-double-stranded Deoxyribonucleic Acid (Anti-dsDNA) Assessments at Week 24, 32, 40 and 52 | Week 24: Positive ANA | 13 Participants |
| MSB11022 (Core Treatment Period) | Number of Participants With Anti-nuclear Antibodies (ANA) and Anti-double-stranded Deoxyribonucleic Acid (Anti-dsDNA) Assessments at Week 24, 32, 40 and 52 | Week 40: Intermediate anti-dsDNA | 7 Participants |
| MSB11022 (Core Treatment Period) | Number of Participants With Anti-nuclear Antibodies (ANA) and Anti-double-stranded Deoxyribonucleic Acid (Anti-dsDNA) Assessments at Week 24, 32, 40 and 52 | Week 24: Intermediate anti-dsDNA | 3 Participants |
| MSB11022 (Core Treatment Period) | Number of Participants With Anti-nuclear Antibodies (ANA) and Anti-double-stranded Deoxyribonucleic Acid (Anti-dsDNA) Assessments at Week 24, 32, 40 and 52 | Week 32: Positive ANA | 13 Participants |
| MSB11022 (Core Treatment Period) | Number of Participants With Anti-nuclear Antibodies (ANA) and Anti-double-stranded Deoxyribonucleic Acid (Anti-dsDNA) Assessments at Week 24, 32, 40 and 52 | Week 40: Negative ANA | 178 Participants |
| MSB11022 (Core Treatment Period) | Number of Participants With Anti-nuclear Antibodies (ANA) and Anti-double-stranded Deoxyribonucleic Acid (Anti-dsDNA) Assessments at Week 24, 32, 40 and 52 | Week 52: Positive anti-dsDNA | 11 Participants |
| MSB11022 (Core Treatment Period) | Number of Participants With Anti-nuclear Antibodies (ANA) and Anti-double-stranded Deoxyribonucleic Acid (Anti-dsDNA) Assessments at Week 24, 32, 40 and 52 | Week 40: Positive ANA | 18 Participants |
| MSB11022 (Core Treatment Period) | Number of Participants With Anti-nuclear Antibodies (ANA) and Anti-double-stranded Deoxyribonucleic Acid (Anti-dsDNA) Assessments at Week 24, 32, 40 and 52 | Week 32: Negative ANA | 186 Participants |
| EU-Humira | Number of Participants With Anti-nuclear Antibodies (ANA) and Anti-double-stranded Deoxyribonucleic Acid (Anti-dsDNA) Assessments at Week 24, 32, 40 and 52 | Week 32: Intermediate anti-dsDNA | 2 Participants |
| EU-Humira | Number of Participants With Anti-nuclear Antibodies (ANA) and Anti-double-stranded Deoxyribonucleic Acid (Anti-dsDNA) Assessments at Week 24, 32, 40 and 52 | Week 24: Negative ANA | 89 Participants |
| EU-Humira | Number of Participants With Anti-nuclear Antibodies (ANA) and Anti-double-stranded Deoxyribonucleic Acid (Anti-dsDNA) Assessments at Week 24, 32, 40 and 52 | Week 32: Negative ANA | 85 Participants |
| EU-Humira | Number of Participants With Anti-nuclear Antibodies (ANA) and Anti-double-stranded Deoxyribonucleic Acid (Anti-dsDNA) Assessments at Week 24, 32, 40 and 52 | Week 40: Negative ANA | 85 Participants |
| EU-Humira | Number of Participants With Anti-nuclear Antibodies (ANA) and Anti-double-stranded Deoxyribonucleic Acid (Anti-dsDNA) Assessments at Week 24, 32, 40 and 52 | Week 52: Negative ANA | 84 Participants |
| EU-Humira | Number of Participants With Anti-nuclear Antibodies (ANA) and Anti-double-stranded Deoxyribonucleic Acid (Anti-dsDNA) Assessments at Week 24, 32, 40 and 52 | Week 24: Positive ANA | 5 Participants |
| EU-Humira | Number of Participants With Anti-nuclear Antibodies (ANA) and Anti-double-stranded Deoxyribonucleic Acid (Anti-dsDNA) Assessments at Week 24, 32, 40 and 52 | Week 32: Positive ANA | 3 Participants |
| EU-Humira | Number of Participants With Anti-nuclear Antibodies (ANA) and Anti-double-stranded Deoxyribonucleic Acid (Anti-dsDNA) Assessments at Week 24, 32, 40 and 52 | Week 40: Positive ANA | 6 Participants |
| EU-Humira | Number of Participants With Anti-nuclear Antibodies (ANA) and Anti-double-stranded Deoxyribonucleic Acid (Anti-dsDNA) Assessments at Week 24, 32, 40 and 52 | Week 52: Positive ANA | 3 Participants |
| EU-Humira | Number of Participants With Anti-nuclear Antibodies (ANA) and Anti-double-stranded Deoxyribonucleic Acid (Anti-dsDNA) Assessments at Week 24, 32, 40 and 52 | Week 24: Negative anti-dsDNA | 89 Participants |
| EU-Humira | Number of Participants With Anti-nuclear Antibodies (ANA) and Anti-double-stranded Deoxyribonucleic Acid (Anti-dsDNA) Assessments at Week 24, 32, 40 and 52 | Week 32: Negative anti-dsDNA | 83 Participants |
| EU-Humira | Number of Participants With Anti-nuclear Antibodies (ANA) and Anti-double-stranded Deoxyribonucleic Acid (Anti-dsDNA) Assessments at Week 24, 32, 40 and 52 | Week 40: Negative anti-dsDNA | 86 Participants |
| EU-Humira | Number of Participants With Anti-nuclear Antibodies (ANA) and Anti-double-stranded Deoxyribonucleic Acid (Anti-dsDNA) Assessments at Week 24, 32, 40 and 52 | Week 52: Negative anti-dsDNA | 81 Participants |
| EU-Humira | Number of Participants With Anti-nuclear Antibodies (ANA) and Anti-double-stranded Deoxyribonucleic Acid (Anti-dsDNA) Assessments at Week 24, 32, 40 and 52 | Week 24: Positive anti-dsDNA | 3 Participants |
| EU-Humira | Number of Participants With Anti-nuclear Antibodies (ANA) and Anti-double-stranded Deoxyribonucleic Acid (Anti-dsDNA) Assessments at Week 24, 32, 40 and 52 | Week 32: Positive anti-dsDNA | 3 Participants |
| EU-Humira | Number of Participants With Anti-nuclear Antibodies (ANA) and Anti-double-stranded Deoxyribonucleic Acid (Anti-dsDNA) Assessments at Week 24, 32, 40 and 52 | Week 40: Positive anti-dsDNA | 3 Participants |
| EU-Humira | Number of Participants With Anti-nuclear Antibodies (ANA) and Anti-double-stranded Deoxyribonucleic Acid (Anti-dsDNA) Assessments at Week 24, 32, 40 and 52 | Week 52: Positive anti-dsDNA | 2 Participants |
| EU-Humira | Number of Participants With Anti-nuclear Antibodies (ANA) and Anti-double-stranded Deoxyribonucleic Acid (Anti-dsDNA) Assessments at Week 24, 32, 40 and 52 | Week 24: Intermediate anti-dsDNA | 3 Participants |
| EU-Humira | Number of Participants With Anti-nuclear Antibodies (ANA) and Anti-double-stranded Deoxyribonucleic Acid (Anti-dsDNA) Assessments at Week 24, 32, 40 and 52 | Week 40: Intermediate anti-dsDNA | 2 Participants |
| EU-Humira | Number of Participants With Anti-nuclear Antibodies (ANA) and Anti-double-stranded Deoxyribonucleic Acid (Anti-dsDNA) Assessments at Week 24, 32, 40 and 52 | Week 52: Intermediate anti-dsDNA | 4 Participants |
| EU-Humira/MSB11022 | Number of Participants With Anti-nuclear Antibodies (ANA) and Anti-double-stranded Deoxyribonucleic Acid (Anti-dsDNA) Assessments at Week 24, 32, 40 and 52 | Week 32: Negative ANA | 88 Participants |
| EU-Humira/MSB11022 | Number of Participants With Anti-nuclear Antibodies (ANA) and Anti-double-stranded Deoxyribonucleic Acid (Anti-dsDNA) Assessments at Week 24, 32, 40 and 52 | Week 32: Positive anti-dsDNA | 5 Participants |
| EU-Humira/MSB11022 | Number of Participants With Anti-nuclear Antibodies (ANA) and Anti-double-stranded Deoxyribonucleic Acid (Anti-dsDNA) Assessments at Week 24, 32, 40 and 52 | Week 40: Positive ANA | 7 Participants |
| EU-Humira/MSB11022 | Number of Participants With Anti-nuclear Antibodies (ANA) and Anti-double-stranded Deoxyribonucleic Acid (Anti-dsDNA) Assessments at Week 24, 32, 40 and 52 | Week 52: Intermediate anti-dsDNA | 2 Participants |
| EU-Humira/MSB11022 | Number of Participants With Anti-nuclear Antibodies (ANA) and Anti-double-stranded Deoxyribonucleic Acid (Anti-dsDNA) Assessments at Week 24, 32, 40 and 52 | Week 40: Positive anti-dsDNA | 7 Participants |
| EU-Humira/MSB11022 | Number of Participants With Anti-nuclear Antibodies (ANA) and Anti-double-stranded Deoxyribonucleic Acid (Anti-dsDNA) Assessments at Week 24, 32, 40 and 52 | Week 32: Positive ANA | 7 Participants |
| EU-Humira/MSB11022 | Number of Participants With Anti-nuclear Antibodies (ANA) and Anti-double-stranded Deoxyribonucleic Acid (Anti-dsDNA) Assessments at Week 24, 32, 40 and 52 | Week 40: Intermediate anti-dsDNA | 1 Participants |
| EU-Humira/MSB11022 | Number of Participants With Anti-nuclear Antibodies (ANA) and Anti-double-stranded Deoxyribonucleic Acid (Anti-dsDNA) Assessments at Week 24, 32, 40 and 52 | Week 52: Positive anti-dsDNA | 7 Participants |
| EU-Humira/MSB11022 | Number of Participants With Anti-nuclear Antibodies (ANA) and Anti-double-stranded Deoxyribonucleic Acid (Anti-dsDNA) Assessments at Week 24, 32, 40 and 52 | Week 24: Positive ANA | 5 Participants |
| EU-Humira/MSB11022 | Number of Participants With Anti-nuclear Antibodies (ANA) and Anti-double-stranded Deoxyribonucleic Acid (Anti-dsDNA) Assessments at Week 24, 32, 40 and 52 | Week 24: Negative ANA | 92 Participants |
| EU-Humira/MSB11022 | Number of Participants With Anti-nuclear Antibodies (ANA) and Anti-double-stranded Deoxyribonucleic Acid (Anti-dsDNA) Assessments at Week 24, 32, 40 and 52 | Week 24: Intermediate anti-dsDNA | 1 Participants |
| EU-Humira/MSB11022 | Number of Participants With Anti-nuclear Antibodies (ANA) and Anti-double-stranded Deoxyribonucleic Acid (Anti-dsDNA) Assessments at Week 24, 32, 40 and 52 | Week 52: Negative ANA | 79 Participants |
| EU-Humira/MSB11022 | Number of Participants With Anti-nuclear Antibodies (ANA) and Anti-double-stranded Deoxyribonucleic Acid (Anti-dsDNA) Assessments at Week 24, 32, 40 and 52 | Week 40: Negative anti-dsDNA | 84 Participants |
| EU-Humira/MSB11022 | Number of Participants With Anti-nuclear Antibodies (ANA) and Anti-double-stranded Deoxyribonucleic Acid (Anti-dsDNA) Assessments at Week 24, 32, 40 and 52 | Week 32: Negative anti-dsDNA | 86 Participants |
| EU-Humira/MSB11022 | Number of Participants With Anti-nuclear Antibodies (ANA) and Anti-double-stranded Deoxyribonucleic Acid (Anti-dsDNA) Assessments at Week 24, 32, 40 and 52 | Week 40: Negative ANA | 85 Participants |
| EU-Humira/MSB11022 | Number of Participants With Anti-nuclear Antibodies (ANA) and Anti-double-stranded Deoxyribonucleic Acid (Anti-dsDNA) Assessments at Week 24, 32, 40 and 52 | Week 52: Negative anti-dsDNA | 79 Participants |
| EU-Humira/MSB11022 | Number of Participants With Anti-nuclear Antibodies (ANA) and Anti-double-stranded Deoxyribonucleic Acid (Anti-dsDNA) Assessments at Week 24, 32, 40 and 52 | Week 24: Negative anti-dsDNA | 88 Participants |
| EU-Humira/MSB11022 | Number of Participants With Anti-nuclear Antibodies (ANA) and Anti-double-stranded Deoxyribonucleic Acid (Anti-dsDNA) Assessments at Week 24, 32, 40 and 52 | Week 32: Intermediate anti-dsDNA | 2 Participants |
| EU-Humira/MSB11022 | Number of Participants With Anti-nuclear Antibodies (ANA) and Anti-double-stranded Deoxyribonucleic Acid (Anti-dsDNA) Assessments at Week 24, 32, 40 and 52 | Week 24: Positive anti-dsDNA | 5 Participants |
| EU-Humira/MSB11022 | Number of Participants With Anti-nuclear Antibodies (ANA) and Anti-double-stranded Deoxyribonucleic Acid (Anti-dsDNA) Assessments at Week 24, 32, 40 and 52 | Week 52: Positive ANA | 8 Participants |
Secondary
Number of Participants With Change From Baseline in Physician's Global Assessment (PGA) Score to Clear or Almost Clear at Week 16
PGA was assessed relative to baseline condition based on a scale ranged from 0 to 4, where 0 indicates Clear condition (no signs of psoriasis, post-inflammatory hyperpigmentation may be present), 1 indicates Almost clear condition (normal to pink coloration of lesion, no thickening and no to minimal \[focal\] scaling), 2 indicates Mild condition (pink to light red coloration, just detectable to mild thickening and predominantly fine scaling), 3 indicates Moderate condition (dull bright red, clearly distinguishable erythema, clearly distinguishable to moderate thickening and moderate scaling), and 4 indicates Severe condition (bright to deep dark red coloration, severe thickening with hard edges and severe/coarse scaling covering almost all or all lesions).
Time frame: Baseline (Day 1 of Core Treatment Period), Week 16
Population: PP Analysis set was used. Number of participants with PGA response of Clear or Almost clear at Week 16 were presented.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| MSB11022 (Core Treatment Period) | Number of Participants With Change From Baseline in Physician's Global Assessment (PGA) Score to Clear or Almost Clear at Week 16 | Baseline: Moderate; Week 16: Clear | 52 Participants |
| MSB11022 (Core Treatment Period) | Number of Participants With Change From Baseline in Physician's Global Assessment (PGA) Score to Clear or Almost Clear at Week 16 | Baseline: Moderate; Week 16: Almost clear | 76 Participants |
| MSB11022 (Core Treatment Period) | Number of Participants With Change From Baseline in Physician's Global Assessment (PGA) Score to Clear or Almost Clear at Week 16 | Baseline: Severe; Week 16: Clear | 16 Participants |
| MSB11022 (Core Treatment Period) | Number of Participants With Change From Baseline in Physician's Global Assessment (PGA) Score to Clear or Almost Clear at Week 16 | Baseline: Severe; Week 16: Almost clear | 27 Participants |
| EU-Humira | Number of Participants With Change From Baseline in Physician's Global Assessment (PGA) Score to Clear or Almost Clear at Week 16 | Baseline: Severe; Week 16: Almost clear | 26 Participants |
| EU-Humira | Number of Participants With Change From Baseline in Physician's Global Assessment (PGA) Score to Clear or Almost Clear at Week 16 | Baseline: Moderate; Week 16: Clear | 51 Participants |
| EU-Humira | Number of Participants With Change From Baseline in Physician's Global Assessment (PGA) Score to Clear or Almost Clear at Week 16 | Baseline: Severe; Week 16: Clear | 20 Participants |
| EU-Humira | Number of Participants With Change From Baseline in Physician's Global Assessment (PGA) Score to Clear or Almost Clear at Week 16 | Baseline: Moderate; Week 16: Almost clear | 59 Participants |
Secondary
Number of Participants With Change From Baseline in Physician's Global Assessment (PGA) Score to Clear or Almost Clear at Week 24 and 52
PGA was assessed relative to baseline condition based on a scale ranged from 0 to 4, where 0 indicates clear condition (no signs of psoriasis, post-inflammatory hyperpigmentation may be present), 1 indicates Almost clear condition (normal to pink coloration of lesion, no thickening and no to minimal \[focal\] scaling), 2 indicates mild condition (pink to light red coloration, just detectable to mild thickening and predominantly fine scaling), 3 indicates moderate condition (dull bright red, clearly distinguishable erythema, clearly distinguishable to moderate thickening and moderate scaling), and 4 indicates severe condition (bright to deep dark red coloration, severe thickening with hard edges and severe/coarse scaling covering almost all or all lesions).
Time frame: Baseline (Day 1 of Extended Treatment Period), Week 24 and 52
Population: ETP-PP Analysis set was used. Here Number analyzed indicates number of participants who were evaluable for this outcome measure at specified category. Number of participants with PGA response of Clear or Almost clear at Week 24 and 52 were presented.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| MSB11022 (Core Treatment Period) | Number of Participants With Change From Baseline in Physician's Global Assessment (PGA) Score to Clear or Almost Clear at Week 24 and 52 | Baseline: Moderate; Week 24: Clear | 69 Participants |
| MSB11022 (Core Treatment Period) | Number of Participants With Change From Baseline in Physician's Global Assessment (PGA) Score to Clear or Almost Clear at Week 24 and 52 | Baseline: Severe; Week 24: Clear | 18 Participants |
| MSB11022 (Core Treatment Period) | Number of Participants With Change From Baseline in Physician's Global Assessment (PGA) Score to Clear or Almost Clear at Week 24 and 52 | Baseline: Moderate; Week 24: AlmostClear | 52 Participants |
| MSB11022 (Core Treatment Period) | Number of Participants With Change From Baseline in Physician's Global Assessment (PGA) Score to Clear or Almost Clear at Week 24 and 52 | Baseline: Severe; Week 24: Almost Clear | 27 Participants |
| MSB11022 (Core Treatment Period) | Number of Participants With Change From Baseline in Physician's Global Assessment (PGA) Score to Clear or Almost Clear at Week 24 and 52 | Baseline: Moderate; Week 52: Clear | 74 Participants |
| MSB11022 (Core Treatment Period) | Number of Participants With Change From Baseline in Physician's Global Assessment (PGA) Score to Clear or Almost Clear at Week 24 and 52 | Baseline: Moderate; Week 52: AlmostClear | 40 Participants |
| MSB11022 (Core Treatment Period) | Number of Participants With Change From Baseline in Physician's Global Assessment (PGA) Score to Clear or Almost Clear at Week 24 and 52 | Baseline: Severe; Week 52: Clear | 29 Participants |
| MSB11022 (Core Treatment Period) | Number of Participants With Change From Baseline in Physician's Global Assessment (PGA) Score to Clear or Almost Clear at Week 24 and 52 | Baseline: Severe; Week 52: Almost Clear | 15 Participants |
| EU-Humira | Number of Participants With Change From Baseline in Physician's Global Assessment (PGA) Score to Clear or Almost Clear at Week 24 and 52 | Baseline: Severe; Week 24: Clear | 11 Participants |
| EU-Humira | Number of Participants With Change From Baseline in Physician's Global Assessment (PGA) Score to Clear or Almost Clear at Week 24 and 52 | Baseline: Severe; Week 52: Clear | 17 Participants |
| EU-Humira | Number of Participants With Change From Baseline in Physician's Global Assessment (PGA) Score to Clear or Almost Clear at Week 24 and 52 | Baseline: Severe; Week 24: Almost Clear | 14 Participants |
| EU-Humira | Number of Participants With Change From Baseline in Physician's Global Assessment (PGA) Score to Clear or Almost Clear at Week 24 and 52 | Baseline: Moderate; Week 52: Clear | 29 Participants |
| EU-Humira | Number of Participants With Change From Baseline in Physician's Global Assessment (PGA) Score to Clear or Almost Clear at Week 24 and 52 | Baseline: Moderate; Week 52: AlmostClear | 13 Participants |
| EU-Humira | Number of Participants With Change From Baseline in Physician's Global Assessment (PGA) Score to Clear or Almost Clear at Week 24 and 52 | Baseline: Moderate; Week 24: AlmostClear | 24 Participants |
| EU-Humira | Number of Participants With Change From Baseline in Physician's Global Assessment (PGA) Score to Clear or Almost Clear at Week 24 and 52 | Baseline: Moderate; Week 24: Clear | 25 Participants |
| EU-Humira | Number of Participants With Change From Baseline in Physician's Global Assessment (PGA) Score to Clear or Almost Clear at Week 24 and 52 | Baseline: Severe; Week 52: Almost Clear | 6 Participants |
| EU-Humira/MSB11022 | Number of Participants With Change From Baseline in Physician's Global Assessment (PGA) Score to Clear or Almost Clear at Week 24 and 52 | Baseline: Severe; Week 24: Clear | 9 Participants |
| EU-Humira/MSB11022 | Number of Participants With Change From Baseline in Physician's Global Assessment (PGA) Score to Clear or Almost Clear at Week 24 and 52 | Baseline: Moderate; Week 24: Clear | 25 Participants |
| EU-Humira/MSB11022 | Number of Participants With Change From Baseline in Physician's Global Assessment (PGA) Score to Clear or Almost Clear at Week 24 and 52 | Baseline: Moderate; Week 24: AlmostClear | 31 Participants |
| EU-Humira/MSB11022 | Number of Participants With Change From Baseline in Physician's Global Assessment (PGA) Score to Clear or Almost Clear at Week 24 and 52 | Baseline: Severe; Week 24: Almost Clear | 13 Participants |
| EU-Humira/MSB11022 | Number of Participants With Change From Baseline in Physician's Global Assessment (PGA) Score to Clear or Almost Clear at Week 24 and 52 | Baseline: Severe; Week 52: Clear | 16 Participants |
| EU-Humira/MSB11022 | Number of Participants With Change From Baseline in Physician's Global Assessment (PGA) Score to Clear or Almost Clear at Week 24 and 52 | Baseline: Moderate; Week 52: AlmostClear | 16 Participants |
| EU-Humira/MSB11022 | Number of Participants With Change From Baseline in Physician's Global Assessment (PGA) Score to Clear or Almost Clear at Week 24 and 52 | Baseline: Moderate; Week 52: Clear | 34 Participants |
| EU-Humira/MSB11022 | Number of Participants With Change From Baseline in Physician's Global Assessment (PGA) Score to Clear or Almost Clear at Week 24 and 52 | Baseline: Severe; Week 52: Almost Clear | 6 Participants |
Secondary
Number of Participants With Change in Physician's Global Assessment (PGA) From Baseline at Week 16
PGA was assessed relative to baseline condition based on a scale ranged from 0 to 4, where 0 indicates clear condition (no signs of psoriasis, post-inflammatory hyperpigmentation may be present), 1 indicates Almost clear condition (normal to pink coloration of lesion, no thickening and no to minimal \[focal\] scaling), 2 indicates mild condition (pink to light red coloration, just detectable to mild thickening and predominantly fine scaling), 3 indicates moderate condition (dull bright red, clearly distinguishable erythema, clearly distinguishable to moderate thickening and moderate scaling), and 4 indicates severe condition (bright to deep dark red coloration, severe thickening with hard edges and severe/coarse scaling covering almost all or all lesions).
Time frame: Baseline (Day 1 of Core Treatment Period), Week 16
Population: PP Analysis set was used. Only categories for which participants recorded a PGA response were included below.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| MSB11022 (Core Treatment Period) | Number of Participants With Change in Physician's Global Assessment (PGA) From Baseline at Week 16 | Baseline- Severe; Week 16- Clear | 16 Participants |
| MSB11022 (Core Treatment Period) | Number of Participants With Change in Physician's Global Assessment (PGA) From Baseline at Week 16 | Baseline- Moderate; Week 16- Mild | 16 Participants |
| MSB11022 (Core Treatment Period) | Number of Participants With Change in Physician's Global Assessment (PGA) From Baseline at Week 16 | Baseline- Severe; Week 16- Almost Clear | 27 Participants |
| MSB11022 (Core Treatment Period) | Number of Participants With Change in Physician's Global Assessment (PGA) From Baseline at Week 16 | Baseline- Moderate; Week 16- Clear | 52 Participants |
| MSB11022 (Core Treatment Period) | Number of Participants With Change in Physician's Global Assessment (PGA) From Baseline at Week 16 | Baseline- Severe; Week 16- Mild | 12 Participants |
| MSB11022 (Core Treatment Period) | Number of Participants With Change in Physician's Global Assessment (PGA) From Baseline at Week 16 | Baseline- Moderate; Week 16- Moderate | 2 Participants |
| MSB11022 (Core Treatment Period) | Number of Participants With Change in Physician's Global Assessment (PGA) From Baseline at Week 16 | Baseline- Severe; Week 16- Moderate | 2 Participants |
| MSB11022 (Core Treatment Period) | Number of Participants With Change in Physician's Global Assessment (PGA) From Baseline at Week 16 | Baseline- Moderate; Week 16- Almost Clear | 76 Participants |
| EU-Humira | Number of Participants With Change in Physician's Global Assessment (PGA) From Baseline at Week 16 | Baseline- Severe; Week 16- Moderate | 1 Participants |
| EU-Humira | Number of Participants With Change in Physician's Global Assessment (PGA) From Baseline at Week 16 | Baseline- Moderate; Week 16- Almost Clear | 59 Participants |
| EU-Humira | Number of Participants With Change in Physician's Global Assessment (PGA) From Baseline at Week 16 | Baseline- Moderate; Week 16- Mild | 17 Participants |
| EU-Humira | Number of Participants With Change in Physician's Global Assessment (PGA) From Baseline at Week 16 | Baseline- Moderate; Week 16- Moderate | 1 Participants |
| EU-Humira | Number of Participants With Change in Physician's Global Assessment (PGA) From Baseline at Week 16 | Baseline- Severe; Week 16- Clear | 20 Participants |
| EU-Humira | Number of Participants With Change in Physician's Global Assessment (PGA) From Baseline at Week 16 | Baseline- Severe; Week 16- Almost Clear | 26 Participants |
| EU-Humira | Number of Participants With Change in Physician's Global Assessment (PGA) From Baseline at Week 16 | Baseline- Severe; Week 16- Mild | 16 Participants |
| EU-Humira | Number of Participants With Change in Physician's Global Assessment (PGA) From Baseline at Week 16 | Baseline- Moderate; Week 16- Clear | 51 Participants |
Secondary
Number of Participants With Change in Physician's Global Assessment (PGA) From Baseline at Week 24
PGA was assessed relative to baseline condition based on a scale ranged from 0 to 4, where 0 indicates clear condition (no signs of psoriasis, post-inflammatory hyperpigmentation may be present), 1 indicates Almost clear condition (normal to pink coloration of lesion, no thickening and no to minimal \[focal\] scaling), 2 indicates mild condition (pink to light red coloration, just detectable to mild thickening and predominantly fine scaling), 3 indicates moderate condition (dull bright red, clearly distinguishable erythema, clearly distinguishable to moderate thickening and moderate scaling), and 4 indicates severe condition (bright to deep dark red coloration, severe thickening with hard edges and severe/coarse scaling covering almost all or all lesions).
Time frame: Baseline (Day 1 of Extended Treatment Period), Week 24
Population: ETP-PP Analysis set was used. Only categories for which participants recorded a PGA response were included below. Here Number of participants analyzed signifies those who were evaluable for this outcome measure.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| MSB11022 (Core Treatment Period) | Number of Participants With Change in Physician's Global Assessment (PGA) From Baseline at Week 24 | Baseline- Moderate; Week 24- Moderate | 2 Participants |
| MSB11022 (Core Treatment Period) | Number of Participants With Change in Physician's Global Assessment (PGA) From Baseline at Week 24 | Baseline- Severe; Week 24- Severe | 0 Participants |
| MSB11022 (Core Treatment Period) | Number of Participants With Change in Physician's Global Assessment (PGA) From Baseline at Week 24 | Baseline- Severe; Week 24- Almost Clear | 27 Participants |
| MSB11022 (Core Treatment Period) | Number of Participants With Change in Physician's Global Assessment (PGA) From Baseline at Week 24 | Baseline- Severe; Week 24- Clear | 18 Participants |
| MSB11022 (Core Treatment Period) | Number of Participants With Change in Physician's Global Assessment (PGA) From Baseline at Week 24 | Baseline- Moderate; Week 24- Clear | 69 Participants |
| MSB11022 (Core Treatment Period) | Number of Participants With Change in Physician's Global Assessment (PGA) From Baseline at Week 24 | Baseline- Severe; Week 24- Moderate | 2 Participants |
| MSB11022 (Core Treatment Period) | Number of Participants With Change in Physician's Global Assessment (PGA) From Baseline at Week 24 | Baseline- Moderate; Week 24- Mild | 21 Participants |
| MSB11022 (Core Treatment Period) | Number of Participants With Change in Physician's Global Assessment (PGA) From Baseline at Week 24 | Baseline- Moderate; Week 24- Almost Clear | 52 Participants |
| MSB11022 (Core Treatment Period) | Number of Participants With Change in Physician's Global Assessment (PGA) From Baseline at Week 24 | Baseline- Severe; Week 24- Mild | 9 Participants |
| EU-Humira | Number of Participants With Change in Physician's Global Assessment (PGA) From Baseline at Week 24 | Baseline- Severe; Week 24- Clear | 11 Participants |
| EU-Humira | Number of Participants With Change in Physician's Global Assessment (PGA) From Baseline at Week 24 | Baseline- Moderate; Week 24- Clear | 25 Participants |
| EU-Humira | Number of Participants With Change in Physician's Global Assessment (PGA) From Baseline at Week 24 | Baseline- Moderate; Week 24- Almost Clear | 24 Participants |
| EU-Humira | Number of Participants With Change in Physician's Global Assessment (PGA) From Baseline at Week 24 | Baseline- Moderate; Week 24- Mild | 10 Participants |
| EU-Humira | Number of Participants With Change in Physician's Global Assessment (PGA) From Baseline at Week 24 | Baseline- Moderate; Week 24- Moderate | 2 Participants |
| EU-Humira | Number of Participants With Change in Physician's Global Assessment (PGA) From Baseline at Week 24 | Baseline- Severe; Week 24- Almost Clear | 14 Participants |
| EU-Humira | Number of Participants With Change in Physician's Global Assessment (PGA) From Baseline at Week 24 | Baseline- Severe; Week 24- Mild | 6 Participants |
| EU-Humira | Number of Participants With Change in Physician's Global Assessment (PGA) From Baseline at Week 24 | Baseline- Severe; Week 24- Moderate | 1 Participants |
| EU-Humira | Number of Participants With Change in Physician's Global Assessment (PGA) From Baseline at Week 24 | Baseline- Severe; Week 24- Severe | 1 Participants |
| EU-Humira/MSB11022 | Number of Participants With Change in Physician's Global Assessment (PGA) From Baseline at Week 24 | Baseline- Moderate; Week 24- Mild | 7 Participants |
| EU-Humira/MSB11022 | Number of Participants With Change in Physician's Global Assessment (PGA) From Baseline at Week 24 | Baseline- Moderate; Week 24- Clear | 25 Participants |
| EU-Humira/MSB11022 | Number of Participants With Change in Physician's Global Assessment (PGA) From Baseline at Week 24 | Baseline- Severe; Week 24- Mild | 6 Participants |
| EU-Humira/MSB11022 | Number of Participants With Change in Physician's Global Assessment (PGA) From Baseline at Week 24 | Baseline- Moderate; Week 24- Almost Clear | 31 Participants |
| EU-Humira/MSB11022 | Number of Participants With Change in Physician's Global Assessment (PGA) From Baseline at Week 24 | Baseline- Severe; Week 24- Severe | 0 Participants |
| EU-Humira/MSB11022 | Number of Participants With Change in Physician's Global Assessment (PGA) From Baseline at Week 24 | Baseline- Severe; Week 24- Clear | 9 Participants |
| EU-Humira/MSB11022 | Number of Participants With Change in Physician's Global Assessment (PGA) From Baseline at Week 24 | Baseline- Moderate; Week 24- Moderate | 0 Participants |
| EU-Humira/MSB11022 | Number of Participants With Change in Physician's Global Assessment (PGA) From Baseline at Week 24 | Baseline- Severe; Week 24- Moderate | 1 Participants |
| EU-Humira/MSB11022 | Number of Participants With Change in Physician's Global Assessment (PGA) From Baseline at Week 24 | Baseline- Severe; Week 24- Almost Clear | 13 Participants |
Secondary
Number of Participants With Change in Physician's Global Assessment (PGA) From Baseline at Week 52
PGA was assessed relative to baseline condition based on a scale ranged from 0 to 4, where 0 indicates clear condition (no signs of psoriasis, post-inflammatory hyperpigmentation may be present), 1 indicates Almost clear condition (normal to pink coloration of lesion, no thickening and no to minimal \[focal\] scaling), 2 indicates mild condition (pink to light red coloration, just detectable to mild thickening and predominantly fine scaling), 3 indicates moderate condition (dull bright red, clearly distinguishable erythema, clearly distinguishable to moderate thickening and moderate scaling), and 4 indicates severe condition (bright to deep dark red coloration, severe thickening with hard edges and severe/coarse scaling covering almost all or all lesions).
Time frame: Baseline (Day 1 of Extended Treatment Period), Week 52
Population: ETP-PP Analysis set was used. Here Number of participants analyzed signifies those who were evaluable for this outcome measure. Only categories for which participants recorded a PGA response were included below.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| MSB11022 (Core Treatment Period) | Number of Participants With Change in Physician's Global Assessment (PGA) From Baseline at Week 52 | Baseline- Severe; Week 52- Mild | 3 Participants |
| MSB11022 (Core Treatment Period) | Number of Participants With Change in Physician's Global Assessment (PGA) From Baseline at Week 52 | Baseline- Moderate; Week 52- Missing | 1 Participants |
| MSB11022 (Core Treatment Period) | Number of Participants With Change in Physician's Global Assessment (PGA) From Baseline at Week 52 | Baseline- Severe; Week 52- Severe | 1 Participants |
| MSB11022 (Core Treatment Period) | Number of Participants With Change in Physician's Global Assessment (PGA) From Baseline at Week 52 | Baseline- Severe; Week 52- Almost Clear | 15 Participants |
| MSB11022 (Core Treatment Period) | Number of Participants With Change in Physician's Global Assessment (PGA) From Baseline at Week 52 | Baseline- Severe; Week 52- Clear | 29 Participants |
| MSB11022 (Core Treatment Period) | Number of Participants With Change in Physician's Global Assessment (PGA) From Baseline at Week 52 | Baseline- Moderate; Week 52- Clear | 74 Participants |
| MSB11022 (Core Treatment Period) | Number of Participants With Change in Physician's Global Assessment (PGA) From Baseline at Week 52 | Baseline- Moderate; Week 52- Mild | 17 Participants |
| MSB11022 (Core Treatment Period) | Number of Participants With Change in Physician's Global Assessment (PGA) From Baseline at Week 52 | Baseline- Moderate; Week 52- Almost Clear | 40 Participants |
| MSB11022 (Core Treatment Period) | Number of Participants With Change in Physician's Global Assessment (PGA) From Baseline at Week 52 | Baseline- Severe; Week 52- Moderate | 3 Participants |
| MSB11022 (Core Treatment Period) | Number of Participants With Change in Physician's Global Assessment (PGA) From Baseline at Week 52 | Baseline- Moderate; Week 52- Moderate | 4 Participants |
| MSB11022 (Core Treatment Period) | Number of Participants With Change in Physician's Global Assessment (PGA) From Baseline at Week 52 | Baseline- Severe; Week 52- Missing | 1 Participants |
| EU-Humira | Number of Participants With Change in Physician's Global Assessment (PGA) From Baseline at Week 52 | Baseline- Severe; Week 52- Clear | 17 Participants |
| EU-Humira | Number of Participants With Change in Physician's Global Assessment (PGA) From Baseline at Week 52 | Baseline- Moderate; Week 52- Clear | 29 Participants |
| EU-Humira | Number of Participants With Change in Physician's Global Assessment (PGA) From Baseline at Week 52 | Baseline- Moderate; Week 52- Almost Clear | 13 Participants |
| EU-Humira | Number of Participants With Change in Physician's Global Assessment (PGA) From Baseline at Week 52 | Baseline- Moderate; Week 52- Mild | 11 Participants |
| EU-Humira | Number of Participants With Change in Physician's Global Assessment (PGA) From Baseline at Week 52 | Baseline- Moderate; Week 52- Moderate | 0 Participants |
| EU-Humira | Number of Participants With Change in Physician's Global Assessment (PGA) From Baseline at Week 52 | Baseline- Moderate; Week 52- Missing | 0 Participants |
| EU-Humira | Number of Participants With Change in Physician's Global Assessment (PGA) From Baseline at Week 52 | Baseline- Severe; Week 52- Almost Clear | 6 Participants |
| EU-Humira | Number of Participants With Change in Physician's Global Assessment (PGA) From Baseline at Week 52 | Baseline- Severe; Week 52- Mild | 7 Participants |
| EU-Humira | Number of Participants With Change in Physician's Global Assessment (PGA) From Baseline at Week 52 | Baseline- Severe; Week 52- Moderate | 2 Participants |
| EU-Humira | Number of Participants With Change in Physician's Global Assessment (PGA) From Baseline at Week 52 | Baseline- Severe; Week 52- Severe | 0 Participants |
| EU-Humira | Number of Participants With Change in Physician's Global Assessment (PGA) From Baseline at Week 52 | Baseline- Severe; Week 52- Missing | 0 Participants |
| EU-Humira/MSB11022 | Number of Participants With Change in Physician's Global Assessment (PGA) From Baseline at Week 52 | Baseline- Severe; Week 52- Severe | 0 Participants |
| EU-Humira/MSB11022 | Number of Participants With Change in Physician's Global Assessment (PGA) From Baseline at Week 52 | Baseline- Severe; Week 52- Mild | 3 Participants |
| EU-Humira/MSB11022 | Number of Participants With Change in Physician's Global Assessment (PGA) From Baseline at Week 52 | Baseline- Moderate; Week 52- Mild | 6 Participants |
| EU-Humira/MSB11022 | Number of Participants With Change in Physician's Global Assessment (PGA) From Baseline at Week 52 | Baseline- Moderate; Week 52- Clear | 34 Participants |
| EU-Humira/MSB11022 | Number of Participants With Change in Physician's Global Assessment (PGA) From Baseline at Week 52 | Baseline- Severe; Week 52- Moderate | 2 Participants |
| EU-Humira/MSB11022 | Number of Participants With Change in Physician's Global Assessment (PGA) From Baseline at Week 52 | Baseline- Moderate; Week 52- Almost Clear | 16 Participants |
| EU-Humira/MSB11022 | Number of Participants With Change in Physician's Global Assessment (PGA) From Baseline at Week 52 | Baseline- Severe; Week 52- Clear | 16 Participants |
| EU-Humira/MSB11022 | Number of Participants With Change in Physician's Global Assessment (PGA) From Baseline at Week 52 | Baseline- Moderate; Week 52- Missing | 0 Participants |
| EU-Humira/MSB11022 | Number of Participants With Change in Physician's Global Assessment (PGA) From Baseline at Week 52 | Baseline- Severe; Week 52- Missing | 0 Participants |
| EU-Humira/MSB11022 | Number of Participants With Change in Physician's Global Assessment (PGA) From Baseline at Week 52 | Baseline- Severe; Week 52- Almost Clear | 6 Participants |
| EU-Humira/MSB11022 | Number of Participants With Change in Physician's Global Assessment (PGA) From Baseline at Week 52 | Baseline- Moderate; Week 52- Moderate | 4 Participants |
Secondary
Number of Participants With Clinically Meaningful Differences in Laboratory Values
Based on categories of low, normal, or high according to the laboratory normal ranges, there were no clinically meaningful differences across the treatment groups in the numbers of participants with shifts in Laboratory parameters including hematology, chemistry and urinalysis from normal at Core Baseline to either low or high during the overall treatment period. Clinical meaningful was determined by the investigator.
Time frame: Core Treatment Period: Baseline up to 16; Extended Treatment Period: Baseline up to Week 54
Population: Safety Analysis Set (SAF) was used for up to Week 16. The ETP-SAF was used in Extended Treatment Period.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| MSB11022 (Core Treatment Period) | Number of Participants With Clinically Meaningful Differences in Laboratory Values | 0 Participants |
| EU-Humira | Number of Participants With Clinically Meaningful Differences in Laboratory Values | 0 Participants |
| EU-Humira/MSB11022 | Number of Participants With Clinically Meaningful Differences in Laboratory Values | 0 Participants |
| EU-Humira/EU-Humira | Number of Participants With Clinically Meaningful Differences in Laboratory Values | 0 Participants |
| EU-Humira/MSB11022 | Number of Participants With Clinically Meaningful Differences in Laboratory Values | 0 Participants |
Secondary
Number of Participants With Clinically Meaningful Differences in Vital Signs
Number of participants with clinically meaningful abnormalities in vital signs were reported. Clinical meaningful was determined by the investigator.
Time frame: Core Treatment Period: Baseline up to 16; Extended Treatment Period: Baseline up to Week 54
Population: Safety analysis set was used for Core Treatment Period. ETP-SAF was used for Extended Treatment Period.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| MSB11022 (Core Treatment Period) | Number of Participants With Clinically Meaningful Differences in Vital Signs | 0 Participants |
| EU-Humira | Number of Participants With Clinically Meaningful Differences in Vital Signs | 0 Participants |
| EU-Humira/MSB11022 | Number of Participants With Clinically Meaningful Differences in Vital Signs | 0 Participants |
| EU-Humira/EU-Humira | Number of Participants With Clinically Meaningful Differences in Vital Signs | 0 Participants |
| EU-Humira/MSB11022 | Number of Participants With Clinically Meaningful Differences in Vital Signs | 0 Participants |
Secondary
Number of Participants With Clinically Significant Abnormalities in 12-Electrocardiogram (12-ECG)
Number of participants with clinically significant abnormalities in 12-ECG were reported. Clinical significance was determined by the investigator.
Time frame: Core Treatment Period: Baseline up to 16; Extended Treatment Period: Baseline up to Week 54
Population: Safety analysis set was used for Core Treatment Period. ETP-SAF was used for Extended Treatment Period.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| MSB11022 (Core Treatment Period) | Number of Participants With Clinically Significant Abnormalities in 12-Electrocardiogram (12-ECG) | 0 Participants |
| EU-Humira | Number of Participants With Clinically Significant Abnormalities in 12-Electrocardiogram (12-ECG) | 1 Participants |
| EU-Humira/MSB11022 | Number of Participants With Clinically Significant Abnormalities in 12-Electrocardiogram (12-ECG) | 0 Participants |
| EU-Humira/EU-Humira | Number of Participants With Clinically Significant Abnormalities in 12-Electrocardiogram (12-ECG) | 1 Participants |
| EU-Humira/MSB11022 | Number of Participants With Clinically Significant Abnormalities in 12-Electrocardiogram (12-ECG) | 1 Participants |
Secondary
Number of Participants With Treatment Emergent Adverse Events (TEAEs), Serious TEAEs, TEAEs of Special Interest and TEAEs Leading to Death up to Week 16
Adverse event(AE) was defined as any untoward medical occurrence in participants which does not necessarily have causal relationship with treatment. AE was any unfavorable and unintended sign(including abnormal laboratory finding), symptom/disease temporally associated with use of medicinal product, whether/not considered related to medicinal product. A serious adverse event(SAE) was AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial/prolonged inpatient hospitalization; congenital anomaly/birth defect or was otherwise considered medically important. Term TEAE is defined as AEs starting/worsening after first intake of the study drug. TEAEs included both Serious TEAEs and non-serious TEAEs.
Time frame: Baseline (Day 1 of Core Treatment Period) up to Week 16
Population: Safety (SAF) Analysis Set included all randomized participants who received at least 1 dose of MSB11022 or EU-Humira. Participants in SAF were analyzed according to actual treatment received initially during the relevant treatment period.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| MSB11022 (Core Treatment Period) | Number of Participants With Treatment Emergent Adverse Events (TEAEs), Serious TEAEs, TEAEs of Special Interest and TEAEs Leading to Death up to Week 16 | Participants with TEAEs | 114 Participants |
| MSB11022 (Core Treatment Period) | Number of Participants With Treatment Emergent Adverse Events (TEAEs), Serious TEAEs, TEAEs of Special Interest and TEAEs Leading to Death up to Week 16 | Participants with Serious TEAEs | 8 Participants |
| MSB11022 (Core Treatment Period) | Number of Participants With Treatment Emergent Adverse Events (TEAEs), Serious TEAEs, TEAEs of Special Interest and TEAEs Leading to Death up to Week 16 | Participants with TEAEs of special interest | 2 Participants |
| MSB11022 (Core Treatment Period) | Number of Participants With Treatment Emergent Adverse Events (TEAEs), Serious TEAEs, TEAEs of Special Interest and TEAEs Leading to Death up to Week 16 | Participants with TEAEs Leading to Death | 0 Participants |
| EU-Humira | Number of Participants With Treatment Emergent Adverse Events (TEAEs), Serious TEAEs, TEAEs of Special Interest and TEAEs Leading to Death up to Week 16 | Participants with TEAEs Leading to Death | 0 Participants |
| EU-Humira | Number of Participants With Treatment Emergent Adverse Events (TEAEs), Serious TEAEs, TEAEs of Special Interest and TEAEs Leading to Death up to Week 16 | Participants with TEAEs | 117 Participants |
| EU-Humira | Number of Participants With Treatment Emergent Adverse Events (TEAEs), Serious TEAEs, TEAEs of Special Interest and TEAEs Leading to Death up to Week 16 | Participants with TEAEs of special interest | 3 Participants |
| EU-Humira | Number of Participants With Treatment Emergent Adverse Events (TEAEs), Serious TEAEs, TEAEs of Special Interest and TEAEs Leading to Death up to Week 16 | Participants with Serious TEAEs | 6 Participants |
Secondary
Number of Participants With Treatment Emergent Adverse Events (TEAEs), Serious TEAEs, TEAEs of Special Interest and TEAEs Leading to Death up to Week 54
Adverse event(AE) was defined as any untoward medical occurrence in participants which does not necessarily have causal relationship with treatment. AE was any unfavorable and unintended sign(including abnormal laboratory finding), symptom/disease temporally associated with use of medicinal product, whether/not considered related to medicinal product. A serious adverse event(SAE) was AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial/prolonged inpatient hospitalization; congenital anomaly/birth defect or was otherwise considered medically important. Term TEAE is defined as AEs starting/worsening after first intake of the study drug. TEAEs included both Serious TEAEs and non-serious TEAEs.
Time frame: Baseline (Day 1 of Extended Treatment Period) up to Week 54
Population: ETP-SAF Analysis Set was used. Participants were analyzed according to actual treatment received initially during the relevant treatment period.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| MSB11022 (Core Treatment Period) | Number of Participants With Treatment Emergent Adverse Events (TEAEs), Serious TEAEs, TEAEs of Special Interest and TEAEs Leading to Death up to Week 54 | Participants with TEAEs | 142 Participants |
| MSB11022 (Core Treatment Period) | Number of Participants With Treatment Emergent Adverse Events (TEAEs), Serious TEAEs, TEAEs of Special Interest and TEAEs Leading to Death up to Week 54 | Participants with Serious TEAEs | 12 Participants |
| MSB11022 (Core Treatment Period) | Number of Participants With Treatment Emergent Adverse Events (TEAEs), Serious TEAEs, TEAEs of Special Interest and TEAEs Leading to Death up to Week 54 | Participants with TEAEs of special interest | 10 Participants |
| MSB11022 (Core Treatment Period) | Number of Participants With Treatment Emergent Adverse Events (TEAEs), Serious TEAEs, TEAEs of Special Interest and TEAEs Leading to Death up to Week 54 | Participants with TEAEs Leading to Death | 0 Participants |
| EU-Humira | Number of Participants With Treatment Emergent Adverse Events (TEAEs), Serious TEAEs, TEAEs of Special Interest and TEAEs Leading to Death up to Week 54 | Participants with TEAEs Leading to Death | 1 Participants |
| EU-Humira | Number of Participants With Treatment Emergent Adverse Events (TEAEs), Serious TEAEs, TEAEs of Special Interest and TEAEs Leading to Death up to Week 54 | Participants with TEAEs | 65 Participants |
| EU-Humira | Number of Participants With Treatment Emergent Adverse Events (TEAEs), Serious TEAEs, TEAEs of Special Interest and TEAEs Leading to Death up to Week 54 | Participants with TEAEs of special interest | 1 Participants |
| EU-Humira | Number of Participants With Treatment Emergent Adverse Events (TEAEs), Serious TEAEs, TEAEs of Special Interest and TEAEs Leading to Death up to Week 54 | Participants with Serious TEAEs | 3 Participants |
| EU-Humira/MSB11022 | Number of Participants With Treatment Emergent Adverse Events (TEAEs), Serious TEAEs, TEAEs of Special Interest and TEAEs Leading to Death up to Week 54 | Participants with TEAEs Leading to Death | 0 Participants |
| EU-Humira/MSB11022 | Number of Participants With Treatment Emergent Adverse Events (TEAEs), Serious TEAEs, TEAEs of Special Interest and TEAEs Leading to Death up to Week 54 | Participants with Serious TEAEs | 4 Participants |
| EU-Humira/MSB11022 | Number of Participants With Treatment Emergent Adverse Events (TEAEs), Serious TEAEs, TEAEs of Special Interest and TEAEs Leading to Death up to Week 54 | Participants with TEAEs of special interest | 4 Participants |
| EU-Humira/MSB11022 | Number of Participants With Treatment Emergent Adverse Events (TEAEs), Serious TEAEs, TEAEs of Special Interest and TEAEs Leading to Death up to Week 54 | Participants with TEAEs | 63 Participants |
Secondary
Observed Serum Concentration at Week 16
Observed serum concentrations at week 16 were reported.
Time frame: Week 16
Population: The Pharmacokinetic (PK) Analysis Set included all participants in the SAF who also had at least 1 measurable post-dose concentration. Here Number of Participants analyzed signifies those who were evaluable for this outcome measure.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| MSB11022 (Core Treatment Period) | Observed Serum Concentration at Week 16 | 6990 Nanogram per milliliter (ng/mL) | Standard Deviation 4504 |
| EU-Humira | Observed Serum Concentration at Week 16 | 6410 Nanogram per milliliter (ng/mL) | Standard Deviation 4152 |
Secondary
Observed Serum Concentration at Week 24 and 52
Observed serum concentrations at week 24 and 52 were reported.
Time frame: Week 24 and 52
Population: The ETP-PK analysis included all participants in ETP SAF who had at least 1 measurable post-dose concentration in ETP, without any important protocol deviations that could have impacted quality of PK data during ETP. Here Number analyzed signifies those participants who were evaluable for this outcome measure at specified time points.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|---|
| MSB11022 (Core Treatment Period) | Observed Serum Concentration at Week 24 and 52 | Week 24 | 6240 ng/mL | Standard Deviation 4569 |
| MSB11022 (Core Treatment Period) | Observed Serum Concentration at Week 24 and 52 | Week 52 | 6910 ng/mL | Standard Deviation 5750 |
| EU-Humira | Observed Serum Concentration at Week 24 and 52 | Week 24 | 5870 ng/mL | Standard Deviation 4516 |
| EU-Humira | Observed Serum Concentration at Week 24 and 52 | Week 52 | 5930 ng/mL | Standard Deviation 4529 |
| EU-Humira/MSB11022 | Observed Serum Concentration at Week 24 and 52 | Week 24 | 6430 ng/mL | Standard Deviation 4610 |
| EU-Humira/MSB11022 | Observed Serum Concentration at Week 24 and 52 | Week 52 | 6600 ng/mL | Standard Deviation 5394 |
Secondary
Patient Global Assessment for Joints on Visual Analog Scale (PJA-VAS) at Week 16
Patient global assessment for joints was measured on a 100 millimeter (mm) VAS scale, where 0 = no pain and 100 = worst possible pain.
Time frame: Week 16
Population: PP analysis set was used. Here Number of participants analyzed signifies participants who were evaluable for this outcome measure at specified category.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| MSB11022 (Core Treatment Period) | Patient Global Assessment for Joints on Visual Analog Scale (PJA-VAS) at Week 16 | 26.9 millimeter (mm) | Standard Deviation 28.3 |
| EU-Humira | Patient Global Assessment for Joints on Visual Analog Scale (PJA-VAS) at Week 16 | 24.6 millimeter (mm) | Standard Deviation 24.3 |
Secondary
Patient Global Assessment for Joints on Visual Analog Scale (PJA-VAS) at Week 24 and 52
Patient global assessment for joints was measured on a 100 millimeter (mm) VAS scale, where 0 = no pain and 100 = worst possible pain.
Time frame: Week 24 and 52
Population: ETP-PP analysis set was used. Here Number analyzed signifies participants who were evaluable for this outcome measure at specified category.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| MSB11022 (Core Treatment Period) | Patient Global Assessment for Joints on Visual Analog Scale (PJA-VAS) at Week 24 and 52 | Week 24 | 29.7 mm | Standard Deviation 25.3 |
| MSB11022 (Core Treatment Period) | Patient Global Assessment for Joints on Visual Analog Scale (PJA-VAS) at Week 24 and 52 | Week 52 | 25.0 mm | Standard Deviation 20.3 |
| EU-Humira | Patient Global Assessment for Joints on Visual Analog Scale (PJA-VAS) at Week 24 and 52 | Week 24 | 20.6 mm | Standard Deviation 27.1 |
| EU-Humira | Patient Global Assessment for Joints on Visual Analog Scale (PJA-VAS) at Week 24 and 52 | Week 52 | 14.7 mm | Standard Deviation 16.5 |
| EU-Humira/MSB11022 | Patient Global Assessment for Joints on Visual Analog Scale (PJA-VAS) at Week 24 and 52 | Week 24 | 24.9 mm | Standard Deviation 20.5 |
| EU-Humira/MSB11022 | Patient Global Assessment for Joints on Visual Analog Scale (PJA-VAS) at Week 24 and 52 | Week 52 | 29.5 mm | Standard Deviation 19.6 |
Secondary
Percentage of Participants Who Achieved PASI 50, 75, 90 and 100 at Week 24
PASI correlates to the physician's assessment of psoriasis symptoms including redness of lesions, thickness of lesions, scaliness of lesions and extent of disease. Each parameter is graded from 0-4, 0 refers to no disease and 4 to severe involvement. The body is divided into 4 areas for scoring (head, arms, trunk to groin, legs to top of buttocks), and the final score ranges from 0-72 with higher scores reflecting more disease severity. The PASI response rate at Week 24 is measured as the percentage of participants who achieved at least 50, 75, 90 and 100% improvement from baseline PASI at Week 24.
Time frame: Week 24
Population: The Extended Treatment Period (ETP)-PP Analysis Set included participants who were in PP Analysis Set \& were re-randomized \& received treatment in Extended Treatment Period. Here Number of participants analyzed signifies those who were evaluable for this outcome measure.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| MSB11022 (Core Treatment Period) | Percentage of Participants Who Achieved PASI 50, 75, 90 and 100 at Week 24 | PASI 50 | 100.0 Percentage of Participants |
| MSB11022 (Core Treatment Period) | Percentage of Participants Who Achieved PASI 50, 75, 90 and 100 at Week 24 | PASI 75 | 92.5 Percentage of Participants |
| MSB11022 (Core Treatment Period) | Percentage of Participants Who Achieved PASI 50, 75, 90 and 100 at Week 24 | PASI 90 | 74.0 Percentage of Participants |
| MSB11022 (Core Treatment Period) | Percentage of Participants Who Achieved PASI 50, 75, 90 and 100 at Week 24 | PASI 100 | 42.5 Percentage of Participants |
| EU-Humira | Percentage of Participants Who Achieved PASI 50, 75, 90 and 100 at Week 24 | PASI 100 | 37.2 Percentage of Participants |
| EU-Humira | Percentage of Participants Who Achieved PASI 50, 75, 90 and 100 at Week 24 | PASI 50 | 98.9 Percentage of Participants |
| EU-Humira | Percentage of Participants Who Achieved PASI 50, 75, 90 and 100 at Week 24 | PASI 90 | 78.7 Percentage of Participants |
| EU-Humira | Percentage of Participants Who Achieved PASI 50, 75, 90 and 100 at Week 24 | PASI 75 | 88.3 Percentage of Participants |
| EU-Humira/MSB11022 | Percentage of Participants Who Achieved PASI 50, 75, 90 and 100 at Week 24 | PASI 100 | 35.9 Percentage of Participants |
| EU-Humira/MSB11022 | Percentage of Participants Who Achieved PASI 50, 75, 90 and 100 at Week 24 | PASI 75 | 94.6 Percentage of Participants |
| EU-Humira/MSB11022 | Percentage of Participants Who Achieved PASI 50, 75, 90 and 100 at Week 24 | PASI 90 | 80.4 Percentage of Participants |
| EU-Humira/MSB11022 | Percentage of Participants Who Achieved PASI 50, 75, 90 and 100 at Week 24 | PASI 50 | 100.0 Percentage of Participants |
Secondary
Percentage of Participants Who Achieved PASI 50, 75, 90 and 100 at Week 52
PASI correlates to the physician's assessment of psoriasis symptoms including redness of lesions, thickness of lesions, scaliness of lesions and extent of disease. Each parameter is graded from 0-4, 0 refers to no disease and 4 to severe involvement. The body is divided into 4 areas for scoring (head, arms, trunk to groin, legs to top of buttocks), and the final score ranges from 0-72 with higher scores reflecting more disease severity. The PASI response rate at Week 52 is measured as the percentage of participants who achieved at least 50, 75, 90 and 100% improvement from baseline PASI at Week 52.
Time frame: Week 52
Population: The ETP-PP Analysis Set was used. Here Number of participants analyzed signifies those who were evaluable for this outcome measure.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| MSB11022 (Core Treatment Period) | Percentage of Participants Who Achieved PASI 50, 75, 90 and 100 at Week 52 | PASI 100 | 53.8 Percentage of Participants |
| MSB11022 (Core Treatment Period) | Percentage of Participants Who Achieved PASI 50, 75, 90 and 100 at Week 52 | PASI 50 | 97.8 Percentage of Participants |
| MSB11022 (Core Treatment Period) | Percentage of Participants Who Achieved PASI 50, 75, 90 and 100 at Week 52 | PASI 75 | 90.9 Percentage of Participants |
| MSB11022 (Core Treatment Period) | Percentage of Participants Who Achieved PASI 50, 75, 90 and 100 at Week 52 | PASI 90 | 76.3 Percentage of Participants |
| EU-Humira | Percentage of Participants Who Achieved PASI 50, 75, 90 and 100 at Week 52 | PASI 90 | 78.8 Percentage of Participants |
| EU-Humira | Percentage of Participants Who Achieved PASI 50, 75, 90 and 100 at Week 52 | PASI 100 | 54.1 Percentage of Participants |
| EU-Humira | Percentage of Participants Who Achieved PASI 50, 75, 90 and 100 at Week 52 | PASI 75 | 92.9 Percentage of Participants |
| EU-Humira | Percentage of Participants Who Achieved PASI 50, 75, 90 and 100 at Week 52 | PASI 50 | 100.0 Percentage of Participants |
| EU-Humira/MSB11022 | Percentage of Participants Who Achieved PASI 50, 75, 90 and 100 at Week 52 | PASI 90 | 85.1 Percentage of Participants |
| EU-Humira/MSB11022 | Percentage of Participants Who Achieved PASI 50, 75, 90 and 100 at Week 52 | PASI 50 | 100.0 Percentage of Participants |
| EU-Humira/MSB11022 | Percentage of Participants Who Achieved PASI 50, 75, 90 and 100 at Week 52 | PASI 75 | 93.1 Percentage of Participants |
| EU-Humira/MSB11022 | Percentage of Participants Who Achieved PASI 50, 75, 90 and 100 at Week 52 | PASI 100 | 57.5 Percentage of Participants |
Secondary
Percentage of Participants Who Achieved PASI 50, 90 and 100 at Week 16
PASI correlates to the physician's assessment of psoriasis symptoms including redness of lesions, thickness of lesions, scaliness of lesions and extent of disease. Each parameter is graded from 0-4, 0 refers to no disease and 4 to severe involvement. The body is divided into 4 areas for scoring (head, arms, trunk to groin, legs to top of buttocks), and the final score ranges from 0-72 with higher scores reflecting more disease severity. The PASI 50, 90 and 100 response rate at Week 16 is measured as the percentage of participants who achieved at least 50, 90 and 100% improvement from baseline PASI score at Week 16.
Time frame: Week 16
Population: PP analysis set was used.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| MSB11022 (Core Treatment Period) | Percentage of Participants Who Achieved PASI 50, 90 and 100 at Week 16 | PASI 50 | 100.0 Percentage of Participants |
| MSB11022 (Core Treatment Period) | Percentage of Participants Who Achieved PASI 50, 90 and 100 at Week 16 | PASI 90 | 64.0 Percentage of Participants |
| MSB11022 (Core Treatment Period) | Percentage of Participants Who Achieved PASI 50, 90 and 100 at Week 16 | PASI 100 | 33.0 Percentage of Participants |
| EU-Humira | Percentage of Participants Who Achieved PASI 50, 90 and 100 at Week 16 | PASI 50 | 100.0 Percentage of Participants |
| EU-Humira | Percentage of Participants Who Achieved PASI 50, 90 and 100 at Week 16 | PASI 90 | 66.0 Percentage of Participants |
| EU-Humira | Percentage of Participants Who Achieved PASI 50, 90 and 100 at Week 16 | PASI 100 | 37.2 Percentage of Participants |
Secondary
Percent Change From Baseline in PASI at Week 16
PASI correlates to the physician's assessment of psoriasis symptoms including redness of lesions, thickness of lesions, scaliness of lesions and extent of disease. Each parameter is graded from 0-4, 0 refers to no disease and 4 to severe involvement. The body is divided into 4 areas for scoring (head, arms, trunk to groin, legs to top of buttocks), and the final score ranges from 0-72, with higher scores reflecting more disease severity. Percent change from Baseline in PASI score was reported.
Time frame: Baseline (Day 1 of Core Treatment Period), Week 16
Population: The PP Analysis set was used.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| MSB11022 (Core Treatment Period) | Percent Change From Baseline in PASI at Week 16 | -90.6 Percent change | Standard Deviation 11.3 |
| EU-Humira | Percent Change From Baseline in PASI at Week 16 | -91.7 Percent change | Standard Deviation 9.9 |
95% CI: [-1.21, 2.98]
Secondary
Percent Change From Baseline in PASI at Week 24 and 52
PASI correlates to the physician's assessment of psoriasis symptoms including redness of lesions, thickness of lesions, scaliness of lesions and extent of disease. Each parameter is graded from 0-4, 0 refers to no disease and 4 to severe involvement. The body is divided into 4 areas for scoring (head, arms, trunk to groin, legs to top of buttocks), and the final score ranges from 0-72, with higher scores reflecting more disease severity.
Time frame: Baseline (Day 1 of Extended Treatment Period), Weeks 24 and 52
Population: The ETP-PP analysis set was used. Here Number analyzed Signifies those participants who were evaluable for this outcome measure at specified time points.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| MSB11022 (Core Treatment Period) | Percent Change From Baseline in PASI at Week 24 and 52 | Week 24 | -92.9 Percent change | Standard Deviation 9.9 |
| MSB11022 (Core Treatment Period) | Percent Change From Baseline in PASI at Week 24 and 52 | Week 52 | -92.8 Percent change | Standard Deviation 13.6 |
| EU-Humira | Percent Change From Baseline in PASI at Week 24 and 52 | Week 24 | -91.3 Percent change | Standard Deviation 12.7 |
| EU-Humira | Percent Change From Baseline in PASI at Week 24 and 52 | Week 52 | -93.9 Percent change | Standard Deviation 9.6 |
| EU-Humira/MSB11022 | Percent Change From Baseline in PASI at Week 24 and 52 | Week 24 | -94.2 Percent change | Standard Deviation 8.2 |
| EU-Humira/MSB11022 | Percent Change From Baseline in PASI at Week 24 and 52 | Week 52 | -94.8 Percent change | Standard Deviation 9.7 |
Secondary
Time to Achieve PASI 100
PASI correlates to the physician's assessment of psoriasis symptoms including redness of lesions, thickness of lesions, scaliness of lesions and extent of disease. Each parameter is graded from 0-4, 0 refers to no disease and 4 to severe involvement. The body is divided into 4 areas for scoring (head, arms, trunk to groin, legs to top of buttocks), and the final score ranges from 0-72, with higher scores reflecting more disease severity. Time to achieve at least 100% improvement in PASI from baseline was measured.
Time frame: Baseline (Day 1 of Core Treatment Period) up to Month 13.5
Population: ETP-PP analysis set was used.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| MSB11022 (Core Treatment Period) | Time to Achieve PASI 100 | 7.2 Month |
| EU-Humira | Time to Achieve PASI 100 | 7.2 Month |
| EU-Humira/MSB11022 | Time to Achieve PASI 100 | 8.9 Month |
Secondary
Time to Achieve PASI 50
PASI correlates to the physician's assessment of psoriasis symptoms including redness of lesions, thickness of lesions, scaliness of lesions and extent of disease. Each parameter is graded from 0-4, 0 refers to no disease and 4 to severe involvement. The body is divided into 4 areas for scoring (head, arms, trunk to groin, legs to top of buttocks), and the final score ranges from 0-72, with higher scores reflecting more disease severity. Time to achieve at least 50% improvement in PASI from baseline was measured.
Time frame: Baseline (Day 1 of Core Treatment Period) up to Month 4
Population: PP analysis set was used.
| Arm | Measure | Value (MEDIAN) | Dispersion |
|---|---|---|---|
| MSB11022 (Core Treatment Period) | Time to Achieve PASI 50 | 1.6 Months | Full Range 0.2 |
| EU-Humira | Time to Achieve PASI 50 | 1.6 Months | Full Range 0.2 |
Secondary
Time to Achieve PASI 75
PASI correlates to the physician's assessment of psoriasis symptoms including redness of lesions, thickness of lesions, scaliness of lesions and extent of disease. Each parameter is graded from 0-4, 0 refers to no disease and 4 to severe involvement. The body is divided into 4 areas for scoring (head, arms, trunk to groin, legs to top of buttocks), and the final score ranges from 0-72, with higher scores reflecting more disease severity. Time to achieve at least 75% improvement in PASI from baseline was measured.
Time frame: Baseline (Day 1 of Core Treatment Period) up to Month 4
Population: PP analysis set was used.
| Arm | Measure | Value (MEDIAN) | Dispersion |
|---|---|---|---|
| MSB11022 (Core Treatment Period) | Time to Achieve PASI 75 | 2.5 Months | Full Range 0.2 |
| EU-Humira | Time to Achieve PASI 75 | 1.7 Months | Full Range 0.7 |
Secondary
Time to Achieve PASI 90
PASI correlates to the physician's assessment of psoriasis symptoms including redness of lesions, thickness of lesions, scaliness of lesions and extent of disease. Each parameter is graded from 0-4, 0 refers to no disease and 4 to severe involvement. The body is divided into 4 areas for scoring (head, arms, trunk to groin, legs to top of buttocks), and the final score ranges from 0-72, with higher scores reflecting more disease severity. Time to achieve at least 90% improvement in PASI from baseline was measured.
Time frame: Baseline (Day 1 of Core Treatment Period) up to Month 4
Population: PP analysis set was used.
| Arm | Measure | Value (MEDIAN) | Dispersion |
|---|---|---|---|
| MSB11022 (Core Treatment Period) | Time to Achieve PASI 90 | 3.4 Months | Full Range 0.7 |
| EU-Humira | Time to Achieve PASI 90 | 2.6 Months | Full Range 1.4 |