Psoriasis
Conditions
Brief summary
This is a prospective Phase 4, open-label, non-randomized, observational, multi-center study of infliximab in participants with plaque-type psoriasis to assess the clinical response in real-world practice of long-term maintenance therapy with infliximab 5 mg/kg body weight in a psoriasis population, prescribed in a regimen in accordance with the product monograph (PM) for Canada, the approved summary sheet of product characteristics (SPC) for countries in the European Union (EU), or per label according to local guidelines for all other participating countries.
Detailed description
This study will be conducted in two phases: the 50-week treatment period and the 48-week extended treatment period.
Interventions
BIOLOGICALInfliximab
Infliximab administered intravenously at a dose of 5 mg/kg body weight at Weeks 0, 2, 6 and then every 8 weeks (Weeks 14, 22, 30, 38, and 46 for the Treatment Period and Week 54, 62, 70, 78, 86, and 94 for the Extended Treatment Period) as per the product monograph (PM; Canada), summary of product characteristics (SPC; European Union), or local labeling (for all other countries).
Sponsors
Merck Sharp & Dohme LLC
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Participant must have a diagnosis of plaque-type psoriasis * Participant's physician must have decided, with the subject's consent, to start treatment with infliximab * Participant must demonstrate willingness to participate in the study and agree with the procedures of the study by signing the written informed consent * For inclusion into the extended treatment period, participant must have completed 50 weeks of infliximab treatment in the treatment period * For inclusion into the extended treatment period, participant must be continuing treatment with intravenous infliximab * For inclusion into the extended treatment period, participant must have an improvement in their PASI score of greater than or equal to 25% at the time of entry into to the extended treatment period
Exclusion criteria
For the Treatment Period * Given the non-interventional nature of the study, no specific
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With a Psoriasis Area Sensitivity Index (PASI)-75 Response at Week 50 | Week 50 | Participant PASI scores were used to measure the severity and extent of psoriasis. Using a scale of 0=none to 4= very severe, each body region (head, trunk, arms, and legs) is rated for redness, thickness and scaling of the largest psoriatic area in that region; these 4 totals (totals ranging from 0 to 16) are then multiplied by the standardized percentage of total body area that each region represents (head = 0.1 of body surface area, trunk = 0.2 of body surface area, arms=0.3 of the body surface area, and legs = 0.4 of body surface area). An assessment is then made of the percentage of the area in that body region that is involved by the psoriatic lesions; this is expressed by a score from 0 (0% involved) to 6 (100% involved) and this score is multiplied by the subtotal of the total body area of that region; the four region scores are then added to produce the total PASI score. PASI-75 response was defined as \>=75% improvement in overall PASI score when compared to baseline. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Particpants With a PASI-90 or PASI-75 at Week 50 Among Participants With a PASI-75 Response at Week 14 | Week 50 | Using a scale of 0=none to 4= very severe, each body region (head, trunk, arms, and legs) is rated for redness, thickness and scaling of the largest psoriatic area in that region; these 4 totals (totals ranging from 0 to 16) are then multiplied by the standardized percentage of total body area that each region represents (head = 0.1 of body surface area, trunk = 0.2 of body surface area, arms=0.3 of the body surface area, and legs = 0.4 of body surface area). An assessment is then made of the percentage of the area in that body region that is involved by the psoriatic lesions; this is expressed by a score from 0 (0% involved) to 6 (100% involved) and this score is multiplied by the subtotal of the total body area of that region; the four region scores are then added to produce the total PASI score. PASI-90 and PASI-75 response were defined as \>=90% improvement and a \>=75% improvement, respectively, in overall PASI score when compared to baseline. |
| Number of Participants With a PASI-90, PASI-75, or PASI-50 Response at Week 50 Among Participants With a PASI-50 Response at Week 14 | Week 50 | Using a scale of 0=none to 4= very severe, each body region (head, trunk, arms, and legs) is rated for redness, thickness and scaling of the largest psoriatic area in that region; these 4 totals (ranging from 0 to 16) are then multiplied by the standardized percentage of total body area that each region represents (head = 0.1 of body surface area, trunk = 0.2 of body surface area, arms=0.3 of the body surface area, and legs = 0.4 of body surface area). An assessment is then made of the percentage of the area in that body region that is involved by the psoriatic lesions; this is expressed by a score from 0 (0% involved) to 6 (100% involved) and this score is multiplied by the subtotal of the total body area of that region; the four region scores are then added to produce the total PASI score. PASI-50, PASI-75, and PASI-90 response were defined as \>=50%, \>=75%, \>=90% improvement in PASI score versus baseline. |
| Number of Participants With a PASI-90 Response at Week 98 Among Participants With a PASI-90 Response at Week 50 and Who Entered the Extended Treatment Period | Week 98 | Participant PSAI scores were used to measure the severity and extent of psoriasis. Using a scale of 0=none to 4=very severe, each body region (head, trunk, arms, and legs) is rate for redness, thickness and scaling of the largest psoriatic area in that region; these 4 totals (ranging from 0 to 16) are then multiplied by the standardized percentage of total body area that each regon represents (head=0.1 of body surface area, trunk=0.2 of body surface area, arms=0.3 of body surface area, legs=0.4 of body surface area). An assessment is then made of the percentage of the area in that body region that is involved by the psoriatic lesions; this is expressed by a score from 0 (0% involved) to 6 (100% involved) and this score is multipled by the subtotal of the body area of that region; the four region scores are then added to produce the total PASI score. PSAI-90 response was defined as \>=90% improvement in overall PASI score when compared to baseline. |
| Number of Participants With a PASI-90, PASI-75, or PASI-50 Response at Week 98 Among Participants With a PASI-50 Response at Week 50 and Who Entered the Extended Treatment Period | Week 98 | Using a scale of 0=none to 4= very severe, each body region (head, trunk, arms, and legs) is rated for redness, thickness and scaling of the largest psoriatic area in that region; these 4 totals (ranging from 0 to 16) are then multiplied by the standardized percentage of total body area that each region represents (head = 0.1 of body surface area, trunk = 0.2 of body surface area, arms=0.3 of the body surface area, and legs = 0.4 of body surface area). An assessment is then made of the percentage of the area in that body region that is involved by the psoriatic lesions; this is expressed by a score from 0 (0% involved) to 6 (100% involved) and this score is multiplied by the subtotal of the total body area of that region; the four region scores are then added to produce the total PASI score. PASI-50, PASI-75, and PASI-90 response were defined as \>=50%, \>=75%, \>=90% improvement in PASI score versus baseline, respectively. |
| Change From Baseline in Mean PASI Score | Baseline, Week 14, Week 30, Week 50, Week 62, Week 78, Week 98 | Using a scale of 0=none to 4= very severe, each body region (head, trunk, arms, and legs) is rated for redness, thickness and scaling of the largest psoriatic area in that region; these 4 totals (ranging from 0 to 16) are then multiplied by the standardized percentage of total body area that each region represents (head = 0.1 of body surface area, trunk = 0.2 of body surface area, arms=0.3 of the body surface area, and legs = 0.4 of body surface area). An assessment is then made of the percentage of the area in that body region that is involved by the psoriatic lesions; this is expressed by a score from 0 (0% involved) to 6 (100% involved) and this score is multiplied by the subtotal of the total body area of that region; the four region scores are then added to produce the total PASI score. Decreasing scores are indicative of improvement in overall PASI score. |
| Number of Participants With a PASI-90 or PASI-75 Response at Week 98 Among Participants Who Had a PASI-75 Response at Week 50 and Who Entered the Extended Treatment Phase | Week 98 | PASI socres were used to measure the severity and extent of psoriasis. Using a scale of 0=nonoe to 4=very severe, each body region (head, trunk, arms, and legs) is rated for redness, thickness, and scaling of the largest psoriatic area in that region; thse 4 totals (ranging from 0 to 16) are then multipled by the standardized percentage of total body area that region represents (head=0.1 of body surface area, trunk=0.2 of body surface area, arms=0.3 of body surface area, and legs=0.4 of body surface area). An assessment is then made of the percentage of area in that body region that is involved by the psoriatic lesions; this is expressed by a score from 0 (0% involved) to 6 (100% involved) and this score is multiplied by the subtotal of the total body area of that region; the four region scores are then added to produce the total PASI score. PASI-90 and PASI-75 response were defined at \>=90% and \>=75% improvement in overall PASI score when compared to baselne, respectively. |
| Change From Baseline in Mean Dermatology Life Quality Index (DLQI) | Baseline, Week 50, Week 62, Week 78, Week 98 | The DLQI assesses the impact of psoriasis on the participants's daily life. DLQI total score comprises 6 different aspects that may affect quality of life: symptoms and feelings, daily activities, leisure, work or school performance, personal relationships, and treatment. DLQI total scores range from 0 to 30, with 0 corresponding to the best quality of life and 30 to the worst with 0-1=no effect on the partipant's life, 2-5=small effect on the participant's life, 6-10= moderate effect on the participant's life, 11=20= very large effect on participant's life, and 21-30 = extremely large effect on participant's life. |
| Number of Participants With a PASI-90 Response at Week 50 Among Participants With a PASI-90 Response at Week 14 | Week 50 | Participant PASI scores were used to measure the severity and extent of psoriasis. Using a scale of 0=none to 4= very severe, each body region (head, trunk, arms, and legs) is rated for redness, thickness and scaling of the largest psoriatic area in that region; these 4 totals (totals ranging from 0 to 16) are then multiplied by the standardized percentage of total body area that each region represents (head = 0.1 of body surface area, trunk = 0.2 of body surface area, arms=0.3 of the body surface area, and legs = 0.4 of body surface area). An assessment is then made of the percentage of the area in that body region that is involved by the psoriatic lesions; this is expressed by a score from 0 (0% involved) to 6 (100% involved) and this score is multiplied by the subtotal of the total body area of that region; the four region scores are then added to produce the total PASI score. PASI-90 response was defined as \>= 90% improvement when compared to baseline. |
| Number of Participants With a PASI-50, PASI-75, PASI-90, or PASI-100 Response at Week 98 | Week 98 | Using a scale of 0=none to 4= very severe, each body region (head, trunk, arms, and legs) is rated for redness, thickness and scaling of the largest psoriatic area in that region; these 4 totals (ranging from 0 to 16) are then multiplied by the standardized percentage of total body area that each region represents (head = 0.1 of body surface area, trunk = 0.2 of body surface area, arms=0.3 of the body surface area, and legs = 0.4 of body surface area). An assessment is then made of the percentage of the area in that body region that is involved by the psoriatic lesions; this is expressed by a score from 0 (0% involved) to 6 (100% involved) and this score is multiplied by the subtotal of the total body area of that region; the four region scores are then added to produce the total PASI score. PASI-50, PASI-75, PASI-90, and PASI-100 response were defined as \>=25%, \>=50%, \>=75%, \>=90%, =100% improvement in PASI score versus baseline, respectively. |
| Number of Participants Who Achieved a PASI-75 Response at Week 50 by Age | Week 50 | Participant PASI scores were used to measure the severity and extent of psoriasis. Using a scale of 0=none to 4= very severe, each body region (head, trunk, arms, and legs) is rated for redness, thickness and scaling of the largest psoriatic area in that region; these 4 totals (totals ranging from 0 to 16) are then multiplied by the standardized percentage of total body area that each region represents (head = 0.1 of body surface area, trunk = 0.2 of body surface area, arms=0.3 of the body surface area, and legs = 0.4 of body surface area). An assessment is then made of the percentage of the area in that body region that is involved by the psoriatic lesions; this is expressed by a score from 0 (0% involved) to 6 (100% involved) and this score is multiplied by the subtotal of the total body area of that region; the four region scores are then added to produce the total PASI score. PASI-75 response was defined as \>=75% improvement in overall PASI score when compared to baseline. |
| Number of Participants Who Achieved a PASI-75 Response at Week 50 by Gender | Week 50 | Participant PASI scores were used to measure the severity and extent of psoriasis. Using a scale of 0=none to 4= very severe, each body region (head, trunk, arms, and legs) is rated for redness, thickness and scaling of the largest psoriatic area in that region; these 4 totals (totals ranging from 0 to 16) are then multiplied by the standardized percentage of total body area that each region represents (head = 0.1 of body surface area, trunk = 0.2 of body surface area, arms=0.3 of the body surface area, and legs = 0.4 of body surface area). An assessment is then made of the percentage of the area in that body region that is involved by the psoriatic lesions; this is expressed by a score from 0 (0% involved) to 6 (100% involved) and this score is multiplied by the subtotal of the total body area of that region; the four region scores are then added to produce the total PASI score. PASI-75 response was defined as \>=75% improvement in overall PASI score when compared to baseline. |
| Number of Participants Who Achieved a PASI-75 Response at Week 50 by Race | Week 50 | Participant PASI scores were used to measure the severity and extent of psoriasis. Using a scale of 0=none to 4= very severe, each body region (head, trunk, arms, and legs) is rated for redness, thickness and scaling of the largest psoriatic area in that region; these 4 totals (totals ranging from 0 to 16) are then multiplied by the standardized percentage of total body area that each region represents (head = 0.1 of body surface area, trunk = 0.2 of body surface area, arms=0.3 of the body surface area, and legs = 0.4 of body surface area). An assessment is then made of the percentage of the area in that body region that is involved by the psoriatic lesions; this is expressed by a score from 0 (0% involved) to 6 (100% involved) and this score is multiplied by the subtotal of the total body area of that region; the four region scores are then added to produce the total PASI score. PASI-75 response was defined as \>=75% improvement in overall PASI score when compared to baseline. |
| Number of Participants Who Achieved a PASI-75 Response at Week 50 by the Presence of Nail Psoriasis at Baseline | Week 50 | Participant PASI scores were used to measure the severity and extent of psoriasis. Using a scale of 0=none to 4= very severe, each body region (head, trunk, arms, and legs) is rated for redness, thickness and scaling of the largest psoriatic area in that region; these 4 totals (totals ranging from 0 to 16) are then multiplied by the standardized percentage of total body area that each region represents (head = 0.1 of body surface area, trunk = 0.2 of body surface area, arms=0.3 of the body surface area, and legs = 0.4 of body surface area). An assessment is then made of the percentage of the area in that body region that is involved by the psoriatic lesions; this is expressed by a score from 0 (0% involved) to 6 (100% involved) and this score is multiplied by the subtotal of the total body area of that region; the four region scores are then added to produce the total PASI score. PASI-75 response was defined as \>=75% improvement in overall PASI score when compared to baseline. |
| Number of Participants Who Achieved a PASI-75 Response at Week 50 by PASI Score at Baseline | Week 50 | Participant PASI scores were used to measure the severity and extent of psoriasis. Using a scale of 0=none to 4= very severe, each body region (head, trunk, arms, and legs) is rated for redness, thickness and scaling of the largest psoriatic area in that region; these 4 totals (totals ranging from 0 to 16) are then multiplied by the standardized percentage of total body area that each region represents (head = 0.1 of body surface area, trunk = 0.2 of body surface area, arms=0.3 of the body surface area, and legs = 0.4 of body surface area). An assessment is then made of the percentage of the area in that body region that is involved by the psoriatic lesions; this is expressed by a score from 0 (0% involved) to 6 (100% involved) and this score is multiplied by the subtotal of the total body area of that region; the four region scores are then added to produce the total PASI score. PASI-75 response was defined as \>=75% improvement in overall PASI score when compared to baseline.. |
| Number of Participants With A DLQI Score of 0 or 1 in the Extended Treatment Phase | Week 50, Week 62, Week 78, Week 98 | The DLQI assesses the impact of psoriasis on the participants's daily life. DLQI total score comprises 6 different aspects that may affect quality of life: symptoms and feelings, daily activities, leisure, work or school performance, personal relationships, and treatment. DLQI total scores range from 0 to 30, with 0 corresponding to the best quality of life and 30 to the worst with 0-1=no effect on the partipant's life, 2-5=small effect on the participant's life, 6-10= moderate effect on the participant's life, 11=20= very large effect on participant's life, and 21-30 = extremely large effect on participant's life. |
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Infliximab 5 mg/kg Infliximab administered intravenously at a dose of 5 mg/kg body weight at Weeks 0, 2, 6 and then every 8 weeks (Weeks 14, 22, 30, 38, and 46 for the Treatment Period and Week 54, 62, 70, 78, 86, and 94 for the Extended Treatment Period) as per the product monograph (PM; Canada), summary of product characteristics (SPC; European Union), or local labeling (for all other countries). | 660 |
| Total | 660 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Extended Treatment Period | Adverse Event | 6 |
| Extended Treatment Period | Lost to Follow-up | 6 |
| Extended Treatment Period | Protocol defined clinical event | 1 |
| Extended Treatment Period | Protocol Violation | 13 |
| Extended Treatment Period | Reasons unrelated to study treatment | 9 |
| Extended Treatment Period | Treatment Failure | 11 |
| Treatment Period | Administrative | 3 |
| Treatment Period | Adverse Event | 87 |
| Treatment Period | Did Not Meet Protocol Eligibility | 1 |
| Treatment Period | Lost to Follow-up | 23 |
| Treatment Period | Protocol Violation | 54 |
| Treatment Period | Transferred to Another Study | 38 |
| Treatment Period | Treatment Failure | 80 |
| Treatment Period | Withdrawal by Subject | 46 |
Baseline characteristics
| Characteristic | Infliximab 5 mg/kg |
|---|---|
| Age, Continuous | 46.3 years STANDARD_DEVIATION 13.5 |
| Sex: Female, Male Female | 230 Participants |
| Sex: Female, Male Male | 430 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 0 / 659 |
| serious Total, serious adverse events | 56 / 659 |
Outcome results
Primary
Number of Participants With a Psoriasis Area Sensitivity Index (PASI)-75 Response at Week 50
Participant PASI scores were used to measure the severity and extent of psoriasis. Using a scale of 0=none to 4= very severe, each body region (head, trunk, arms, and legs) is rated for redness, thickness and scaling of the largest psoriatic area in that region; these 4 totals (totals ranging from 0 to 16) are then multiplied by the standardized percentage of total body area that each region represents (head = 0.1 of body surface area, trunk = 0.2 of body surface area, arms=0.3 of the body surface area, and legs = 0.4 of body surface area). An assessment is then made of the percentage of the area in that body region that is involved by the psoriatic lesions; this is expressed by a score from 0 (0% involved) to 6 (100% involved) and this score is multiplied by the subtotal of the total body area of that region; the four region scores are then added to produce the total PASI score. PASI-75 response was defined as \>=75% improvement in overall PASI score when compared to baseline.
Time frame: Week 50
Population: The Efficacy Population includes all participants with a baseline PASI score within 14 days of the time of the first infusion and at least one post-baseline PASI score.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Infliximab 5 mg/kg | Number of Participants With a Psoriasis Area Sensitivity Index (PASI)-75 Response at Week 50 | 296 Participants |
Secondary
Change From Baseline in Mean Dermatology Life Quality Index (DLQI)
The DLQI assesses the impact of psoriasis on the participants's daily life. DLQI total score comprises 6 different aspects that may affect quality of life: symptoms and feelings, daily activities, leisure, work or school performance, personal relationships, and treatment. DLQI total scores range from 0 to 30, with 0 corresponding to the best quality of life and 30 to the worst with 0-1=no effect on the partipant's life, 2-5=small effect on the participant's life, 6-10= moderate effect on the participant's life, 11=20= very large effect on participant's life, and 21-30 = extremely large effect on participant's life.
Time frame: Baseline, Week 50, Week 62, Week 78, Week 98
Population: The population consisted of all participants with a DLQI measurement at baseline and at each time point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Infliximab 5 mg/kg | Change From Baseline in Mean Dermatology Life Quality Index (DLQI) | Week 50 (n=149) | 9.8 Score on a Scale | Standard Error 0.61 |
| Infliximab 5 mg/kg | Change From Baseline in Mean Dermatology Life Quality Index (DLQI) | Week 98 (n=140) | 9.4 Score on a Scale | Standard Error 0.7 |
| Infliximab 5 mg/kg | Change From Baseline in Mean Dermatology Life Quality Index (DLQI) | Week 62 (n=131) | 9.0 Score on a Scale | Standard Error 0.77 |
| Infliximab 5 mg/kg | Change From Baseline in Mean Dermatology Life Quality Index (DLQI) | Week 78 (n=134) | 9.7 Score on a Scale | Standard Error 0.69 |
Secondary
Change From Baseline in Mean PASI Score
Using a scale of 0=none to 4= very severe, each body region (head, trunk, arms, and legs) is rated for redness, thickness and scaling of the largest psoriatic area in that region; these 4 totals (ranging from 0 to 16) are then multiplied by the standardized percentage of total body area that each region represents (head = 0.1 of body surface area, trunk = 0.2 of body surface area, arms=0.3 of the body surface area, and legs = 0.4 of body surface area). An assessment is then made of the percentage of the area in that body region that is involved by the psoriatic lesions; this is expressed by a score from 0 (0% involved) to 6 (100% involved) and this score is multiplied by the subtotal of the total body area of that region; the four region scores are then added to produce the total PASI score. Decreasing scores are indicative of improvement in overall PASI score.
Time frame: Baseline, Week 14, Week 30, Week 50, Week 62, Week 78, Week 98
Population: The population consists of all participants with a baseline PASI score and a subsequent score at Week 14, 30, 50, 62, 78,and 98.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Infliximab 5 mg/kg | Change From Baseline in Mean PASI Score | Week 30 (n=165) | -18.0 Score on a Scale | 95% Confidence Interval -18 |
| Infliximab 5 mg/kg | Change From Baseline in Mean PASI Score | Week 62 (n=136) | -17.8 Score on a Scale | 95% Confidence Interval -17.8 |
| Infliximab 5 mg/kg | Change From Baseline in Mean PASI Score | Week 78 (n=143) | -17.5 Score on a Scale | 95% Confidence Interval -17.5 |
| Infliximab 5 mg/kg | Change From Baseline in Mean PASI Score | Week 14 (n=166) | -17.3 Score on a Scale | 95% Confidence Interval -17.3 |
| Infliximab 5 mg/kg | Change From Baseline in Mean PASI Score | Week 50 (n=165) | -18.4 Score on a Scale | 95% Confidence Interval -18.4 |
| Infliximab 5 mg/kg | Change From Baseline in Mean PASI Score | Week 98 (n=142) | -17.3 Score on a Scale | 95% Confidence Interval -17.3 |
Secondary
Number of Participants Who Achieved a PASI-75 Response at Week 50 by Age
Participant PASI scores were used to measure the severity and extent of psoriasis. Using a scale of 0=none to 4= very severe, each body region (head, trunk, arms, and legs) is rated for redness, thickness and scaling of the largest psoriatic area in that region; these 4 totals (totals ranging from 0 to 16) are then multiplied by the standardized percentage of total body area that each region represents (head = 0.1 of body surface area, trunk = 0.2 of body surface area, arms=0.3 of the body surface area, and legs = 0.4 of body surface area). An assessment is then made of the percentage of the area in that body region that is involved by the psoriatic lesions; this is expressed by a score from 0 (0% involved) to 6 (100% involved) and this score is multiplied by the subtotal of the total body area of that region; the four region scores are then added to produce the total PASI score. PASI-75 response was defined as \>=75% improvement in overall PASI score when compared to baseline.
Time frame: Week 50
Population: The Efficacy Population includes all participants with a baseline PASI score within 14 days of the time of the first infusion and at least one post-baseline PASI score.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Infliximab 5 mg/kg | Number of Participants Who Achieved a PASI-75 Response at Week 50 by Age | Age <65 years (n=469) | 264 Participants |
| Infliximab 5 mg/kg | Number of Participants Who Achieved a PASI-75 Response at Week 50 by Age | Age >=65 years (n=52) | 32 Participants |
Secondary
Number of Participants Who Achieved a PASI-75 Response at Week 50 by Gender
Participant PASI scores were used to measure the severity and extent of psoriasis. Using a scale of 0=none to 4= very severe, each body region (head, trunk, arms, and legs) is rated for redness, thickness and scaling of the largest psoriatic area in that region; these 4 totals (totals ranging from 0 to 16) are then multiplied by the standardized percentage of total body area that each region represents (head = 0.1 of body surface area, trunk = 0.2 of body surface area, arms=0.3 of the body surface area, and legs = 0.4 of body surface area). An assessment is then made of the percentage of the area in that body region that is involved by the psoriatic lesions; this is expressed by a score from 0 (0% involved) to 6 (100% involved) and this score is multiplied by the subtotal of the total body area of that region; the four region scores are then added to produce the total PASI score. PASI-75 response was defined as \>=75% improvement in overall PASI score when compared to baseline.
Time frame: Week 50
Population: The Efficacy Population includes all participants with a baseline PASI score within 14 days of the time of the first infusion and at least one post-baseline PASI score.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Infliximab 5 mg/kg | Number of Participants Who Achieved a PASI-75 Response at Week 50 by Gender | Male (n=344) | 199 Participants |
| Infliximab 5 mg/kg | Number of Participants Who Achieved a PASI-75 Response at Week 50 by Gender | Female (n=177) | 97 Participants |
Secondary
Number of Participants Who Achieved a PASI-75 Response at Week 50 by PASI Score at Baseline
Participant PASI scores were used to measure the severity and extent of psoriasis. Using a scale of 0=none to 4= very severe, each body region (head, trunk, arms, and legs) is rated for redness, thickness and scaling of the largest psoriatic area in that region; these 4 totals (totals ranging from 0 to 16) are then multiplied by the standardized percentage of total body area that each region represents (head = 0.1 of body surface area, trunk = 0.2 of body surface area, arms=0.3 of the body surface area, and legs = 0.4 of body surface area). An assessment is then made of the percentage of the area in that body region that is involved by the psoriatic lesions; this is expressed by a score from 0 (0% involved) to 6 (100% involved) and this score is multiplied by the subtotal of the total body area of that region; the four region scores are then added to produce the total PASI score. PASI-75 response was defined as \>=75% improvement in overall PASI score when compared to baseline..
Time frame: Week 50
Population: The Efficacy Population includes all participants with a baseline PASI score within 14 days of the time of the first infusion and at least one post-baseline PASI score.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Infliximab 5 mg/kg | Number of Participants Who Achieved a PASI-75 Response at Week 50 by PASI Score at Baseline | Baseline PASI <12 (n=167) | 77 Participants |
| Infliximab 5 mg/kg | Number of Participants Who Achieved a PASI-75 Response at Week 50 by PASI Score at Baseline | Baseline PASI >=12 (n=354) | 219 Participants |
Secondary
Number of Participants Who Achieved a PASI-75 Response at Week 50 by Race
Participant PASI scores were used to measure the severity and extent of psoriasis. Using a scale of 0=none to 4= very severe, each body region (head, trunk, arms, and legs) is rated for redness, thickness and scaling of the largest psoriatic area in that region; these 4 totals (totals ranging from 0 to 16) are then multiplied by the standardized percentage of total body area that each region represents (head = 0.1 of body surface area, trunk = 0.2 of body surface area, arms=0.3 of the body surface area, and legs = 0.4 of body surface area). An assessment is then made of the percentage of the area in that body region that is involved by the psoriatic lesions; this is expressed by a score from 0 (0% involved) to 6 (100% involved) and this score is multiplied by the subtotal of the total body area of that region; the four region scores are then added to produce the total PASI score. PASI-75 response was defined as \>=75% improvement in overall PASI score when compared to baseline.
Time frame: Week 50
Population: The Efficacy Population includes all participants with a baseline PASI score within 14 days of the time of the first infusion and at least one post-baseline PASI score.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Infliximab 5 mg/kg | Number of Participants Who Achieved a PASI-75 Response at Week 50 by Race | Caucasian (n=436) | 235 Participants |
| Infliximab 5 mg/kg | Number of Participants Who Achieved a PASI-75 Response at Week 50 by Race | Non-Caucasian (n=85) | 61 Participants |
Secondary
Number of Participants Who Achieved a PASI-75 Response at Week 50 by the Presence of Nail Psoriasis at Baseline
Participant PASI scores were used to measure the severity and extent of psoriasis. Using a scale of 0=none to 4= very severe, each body region (head, trunk, arms, and legs) is rated for redness, thickness and scaling of the largest psoriatic area in that region; these 4 totals (totals ranging from 0 to 16) are then multiplied by the standardized percentage of total body area that each region represents (head = 0.1 of body surface area, trunk = 0.2 of body surface area, arms=0.3 of the body surface area, and legs = 0.4 of body surface area). An assessment is then made of the percentage of the area in that body region that is involved by the psoriatic lesions; this is expressed by a score from 0 (0% involved) to 6 (100% involved) and this score is multiplied by the subtotal of the total body area of that region; the four region scores are then added to produce the total PASI score. PASI-75 response was defined as \>=75% improvement in overall PASI score when compared to baseline.
Time frame: Week 50
Population: The Efficacy Population includes all participants with a baseline PASI score within 14 days of the time of the first infusion and at least one post-baseline PASI score.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Infliximab 5 mg/kg | Number of Participants Who Achieved a PASI-75 Response at Week 50 by the Presence of Nail Psoriasis at Baseline | Nail Psoriasis Present at Baseline (n=308) | 171 Participants |
| Infliximab 5 mg/kg | Number of Participants Who Achieved a PASI-75 Response at Week 50 by the Presence of Nail Psoriasis at Baseline | Nail Psoriasis Absent at Baseline (n=213) | 125 Participants |
Secondary
Number of Participants With A DLQI Score of 0 or 1 in the Extended Treatment Phase
The DLQI assesses the impact of psoriasis on the participants's daily life. DLQI total score comprises 6 different aspects that may affect quality of life: symptoms and feelings, daily activities, leisure, work or school performance, personal relationships, and treatment. DLQI total scores range from 0 to 30, with 0 corresponding to the best quality of life and 30 to the worst with 0-1=no effect on the partipant's life, 2-5=small effect on the participant's life, 6-10= moderate effect on the participant's life, 11=20= very large effect on participant's life, and 21-30 = extremely large effect on participant's life.
Time frame: Week 50, Week 62, Week 78, Week 98
Population: The population consisted of all participants with a DLQI measurement at each time point.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Infliximab 5 mg/kg | Number of Participants With A DLQI Score of 0 or 1 in the Extended Treatment Phase | Week 50, DLQI=0 | 77 Participants |
| Infliximab 5 mg/kg | Number of Participants With A DLQI Score of 0 or 1 in the Extended Treatment Phase | Week 50, DLQI Missing | 16 Participants |
| Infliximab 5 mg/kg | Number of Participants With A DLQI Score of 0 or 1 in the Extended Treatment Phase | Week 62, DLQI >1 | 57 Participants |
| Infliximab 5 mg/kg | Number of Participants With A DLQI Score of 0 or 1 in the Extended Treatment Phase | Week 62, DLQI Missing | 37 Participants |
| Infliximab 5 mg/kg | Number of Participants With A DLQI Score of 0 or 1 in the Extended Treatment Phase | Week 78, DLQI=0 | 57 Participants |
| Infliximab 5 mg/kg | Number of Participants With A DLQI Score of 0 or 1 in the Extended Treatment Phase | Week 78, DLQI=0 or 1 | 80 Participants |
| Infliximab 5 mg/kg | Number of Participants With A DLQI Score of 0 or 1 in the Extended Treatment Phase | Week 78, DLQI >1 | 55 Participants |
| Infliximab 5 mg/kg | Number of Participants With A DLQI Score of 0 or 1 in the Extended Treatment Phase | Week 78, DLQI Missing | 34 Participants |
| Infliximab 5 mg/kg | Number of Participants With A DLQI Score of 0 or 1 in the Extended Treatment Phase | Week 98, DLQI=0 | 67 Participants |
| Infliximab 5 mg/kg | Number of Participants With A DLQI Score of 0 or 1 in the Extended Treatment Phase | Week 98. DLQI=0 or 1 | 84 Participants |
| Infliximab 5 mg/kg | Number of Participants With A DLQI Score of 0 or 1 in the Extended Treatment Phase | Week 98, DLQI >1 | 57 Participants |
| Infliximab 5 mg/kg | Number of Participants With A DLQI Score of 0 or 1 in the Extended Treatment Phase | Week 98, DLQI Missing | 28 Participants |
| Infliximab 5 mg/kg | Number of Participants With A DLQI Score of 0 or 1 in the Extended Treatment Phase | Week 50, DLQI=0 or 1 | 102 Participants |
| Infliximab 5 mg/kg | Number of Participants With A DLQI Score of 0 or 1 in the Extended Treatment Phase | Week 50, DLQI >1 | 51 Participants |
| Infliximab 5 mg/kg | Number of Participants With A DLQI Score of 0 or 1 in the Extended Treatment Phase | Week 62, DLQI=0 | 51 Participants |
| Infliximab 5 mg/kg | Number of Participants With A DLQI Score of 0 or 1 in the Extended Treatment Phase | Week 62, DLQI=0 or 1 | 75 Participants |
Secondary
Number of Participants With a PASI-50, PASI-75, PASI-90, or PASI-100 Response at Week 98
Using a scale of 0=none to 4= very severe, each body region (head, trunk, arms, and legs) is rated for redness, thickness and scaling of the largest psoriatic area in that region; these 4 totals (ranging from 0 to 16) are then multiplied by the standardized percentage of total body area that each region represents (head = 0.1 of body surface area, trunk = 0.2 of body surface area, arms=0.3 of the body surface area, and legs = 0.4 of body surface area). An assessment is then made of the percentage of the area in that body region that is involved by the psoriatic lesions; this is expressed by a score from 0 (0% involved) to 6 (100% involved) and this score is multiplied by the subtotal of the total body area of that region; the four region scores are then added to produce the total PASI score. PASI-50, PASI-75, PASI-90, and PASI-100 response were defined as \>=25%, \>=50%, \>=75%, \>=90%, =100% improvement in PASI score versus baseline, respectively.
Time frame: Week 98
Population: The population consisted of participants who were in the efficacy population of the treatment phase and who entered into the extended treatment phase with at least one PASI evaluation during the extended treatment phase.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Infliximab 5 mg/kg | Number of Participants With a PASI-50, PASI-75, PASI-90, or PASI-100 Response at Week 98 | PASI-50 | 129 Participants |
| Infliximab 5 mg/kg | Number of Participants With a PASI-50, PASI-75, PASI-90, or PASI-100 Response at Week 98 | PASI-90 | 82 Participants |
| Infliximab 5 mg/kg | Number of Participants With a PASI-50, PASI-75, PASI-90, or PASI-100 Response at Week 98 | PASI-100 | 35 Participants |
| Infliximab 5 mg/kg | Number of Participants With a PASI-50, PASI-75, PASI-90, or PASI-100 Response at Week 98 | PASI-75 | 112 Participants |
Secondary
Number of Participants With a PASI-90 or PASI-75 Response at Week 98 Among Participants Who Had a PASI-75 Response at Week 50 and Who Entered the Extended Treatment Phase
PASI socres were used to measure the severity and extent of psoriasis. Using a scale of 0=nonoe to 4=very severe, each body region (head, trunk, arms, and legs) is rated for redness, thickness, and scaling of the largest psoriatic area in that region; thse 4 totals (ranging from 0 to 16) are then multipled by the standardized percentage of total body area that region represents (head=0.1 of body surface area, trunk=0.2 of body surface area, arms=0.3 of body surface area, and legs=0.4 of body surface area). An assessment is then made of the percentage of area in that body region that is involved by the psoriatic lesions; this is expressed by a score from 0 (0% involved) to 6 (100% involved) and this score is multiplied by the subtotal of the total body area of that region; the four region scores are then added to produce the total PASI score. PASI-90 and PASI-75 response were defined at \>=90% and \>=75% improvement in overall PASI score when compared to baselne, respectively.
Time frame: Week 98
Population: The population consisted of participants who were in the efficacy population of the treatment phase and who entered into the extended treatment phase and had a PASI-75 response at Week 50 with at least one PASI evaluation during the extended treatment phase.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Infliximab 5 mg/kg | Number of Participants With a PASI-90 or PASI-75 Response at Week 98 Among Participants Who Had a PASI-75 Response at Week 50 and Who Entered the Extended Treatment Phase | PASI-90 | 77 Participants |
| Infliximab 5 mg/kg | Number of Participants With a PASI-90 or PASI-75 Response at Week 98 Among Participants Who Had a PASI-75 Response at Week 50 and Who Entered the Extended Treatment Phase | PASI-75 | 101 Participants |
Secondary
Number of Participants With a PASI-90, PASI-75, or PASI-50 Response at Week 50 Among Participants With a PASI-50 Response at Week 14
Using a scale of 0=none to 4= very severe, each body region (head, trunk, arms, and legs) is rated for redness, thickness and scaling of the largest psoriatic area in that region; these 4 totals (ranging from 0 to 16) are then multiplied by the standardized percentage of total body area that each region represents (head = 0.1 of body surface area, trunk = 0.2 of body surface area, arms=0.3 of the body surface area, and legs = 0.4 of body surface area). An assessment is then made of the percentage of the area in that body region that is involved by the psoriatic lesions; this is expressed by a score from 0 (0% involved) to 6 (100% involved) and this score is multiplied by the subtotal of the total body area of that region; the four region scores are then added to produce the total PASI score. PASI-50, PASI-75, and PASI-90 response were defined as \>=50%, \>=75%, \>=90% improvement in PASI score versus baseline.
Time frame: Week 50
Population: The population includes all participants that achieved a PASI-50 response at treatment Week 14.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Infliximab 5 mg/kg | Number of Participants With a PASI-90, PASI-75, or PASI-50 Response at Week 50 Among Participants With a PASI-50 Response at Week 14 | PASI-75 Response | 238 Participants |
| Infliximab 5 mg/kg | Number of Participants With a PASI-90, PASI-75, or PASI-50 Response at Week 50 Among Participants With a PASI-50 Response at Week 14 | PASI-90 Response | 170 Participants |
| Infliximab 5 mg/kg | Number of Participants With a PASI-90, PASI-75, or PASI-50 Response at Week 50 Among Participants With a PASI-50 Response at Week 14 | PASI-50 Response | 292 Participants |
Secondary
Number of Participants With a PASI-90, PASI-75, or PASI-50 Response at Week 98 Among Participants With a PASI-50 Response at Week 50 and Who Entered the Extended Treatment Period
Using a scale of 0=none to 4= very severe, each body region (head, trunk, arms, and legs) is rated for redness, thickness and scaling of the largest psoriatic area in that region; these 4 totals (ranging from 0 to 16) are then multiplied by the standardized percentage of total body area that each region represents (head = 0.1 of body surface area, trunk = 0.2 of body surface area, arms=0.3 of the body surface area, and legs = 0.4 of body surface area). An assessment is then made of the percentage of the area in that body region that is involved by the psoriatic lesions; this is expressed by a score from 0 (0% involved) to 6 (100% involved) and this score is multiplied by the subtotal of the total body area of that region; the four region scores are then added to produce the total PASI score. PASI-50, PASI-75, and PASI-90 response were defined as \>=50%, \>=75%, \>=90% improvement in PASI score versus baseline, respectively.
Time frame: Week 98
Population: The population includes all participants that achieved PASI-50 response at Week 50 and entered the extended treatment phase.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Infliximab 5 mg/kg | Number of Participants With a PASI-90, PASI-75, or PASI-50 Response at Week 98 Among Participants With a PASI-50 Response at Week 50 and Who Entered the Extended Treatment Period | PASI-75 | 107 Participants |
| Infliximab 5 mg/kg | Number of Participants With a PASI-90, PASI-75, or PASI-50 Response at Week 98 Among Participants With a PASI-50 Response at Week 50 and Who Entered the Extended Treatment Period | PASI-50 | 122 Participants |
| Infliximab 5 mg/kg | Number of Participants With a PASI-90, PASI-75, or PASI-50 Response at Week 98 Among Participants With a PASI-50 Response at Week 50 and Who Entered the Extended Treatment Period | PASI-90 | 81 Participants |
Secondary
Number of Participants With a PASI-90 Response at Week 50 Among Participants With a PASI-90 Response at Week 14
Participant PASI scores were used to measure the severity and extent of psoriasis. Using a scale of 0=none to 4= very severe, each body region (head, trunk, arms, and legs) is rated for redness, thickness and scaling of the largest psoriatic area in that region; these 4 totals (totals ranging from 0 to 16) are then multiplied by the standardized percentage of total body area that each region represents (head = 0.1 of body surface area, trunk = 0.2 of body surface area, arms=0.3 of the body surface area, and legs = 0.4 of body surface area). An assessment is then made of the percentage of the area in that body region that is involved by the psoriatic lesions; this is expressed by a score from 0 (0% involved) to 6 (100% involved) and this score is multiplied by the subtotal of the total body area of that region; the four region scores are then added to produce the total PASI score. PASI-90 response was defined as \>= 90% improvement when compared to baseline.
Time frame: Week 50
Population: The population consists of all participants that achieved a PASI-90 response at treatment Week 14.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Infliximab 5 mg/kg | Number of Participants With a PASI-90 Response at Week 50 Among Participants With a PASI-90 Response at Week 14 | 104 Participants |
Secondary
Number of Participants With a PASI-90 Response at Week 98 Among Participants With a PASI-90 Response at Week 50 and Who Entered the Extended Treatment Period
Participant PSAI scores were used to measure the severity and extent of psoriasis. Using a scale of 0=none to 4=very severe, each body region (head, trunk, arms, and legs) is rate for redness, thickness and scaling of the largest psoriatic area in that region; these 4 totals (ranging from 0 to 16) are then multiplied by the standardized percentage of total body area that each regon represents (head=0.1 of body surface area, trunk=0.2 of body surface area, arms=0.3 of body surface area, legs=0.4 of body surface area). An assessment is then made of the percentage of the area in that body region that is involved by the psoriatic lesions; this is expressed by a score from 0 (0% involved) to 6 (100% involved) and this score is multipled by the subtotal of the body area of that region; the four region scores are then added to produce the total PASI score. PSAI-90 response was defined as \>=90% improvement in overall PASI score when compared to baseline.
Time frame: Week 98
Population: The population consists of all participants that achieved PASI-90 response at Week 50 and entered the extended treatment phase.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Infliximab 5 mg/kg | Number of Participants With a PASI-90 Response at Week 98 Among Participants With a PASI-90 Response at Week 50 and Who Entered the Extended Treatment Period | 66 Participants |
Secondary
Number of Particpants With a PASI-90 or PASI-75 at Week 50 Among Participants With a PASI-75 Response at Week 14
Using a scale of 0=none to 4= very severe, each body region (head, trunk, arms, and legs) is rated for redness, thickness and scaling of the largest psoriatic area in that region; these 4 totals (totals ranging from 0 to 16) are then multiplied by the standardized percentage of total body area that each region represents (head = 0.1 of body surface area, trunk = 0.2 of body surface area, arms=0.3 of the body surface area, and legs = 0.4 of body surface area). An assessment is then made of the percentage of the area in that body region that is involved by the psoriatic lesions; this is expressed by a score from 0 (0% involved) to 6 (100% involved) and this score is multiplied by the subtotal of the total body area of that region; the four region scores are then added to produce the total PASI score. PASI-90 and PASI-75 response were defined as \>=90% improvement and a \>=75% improvement, respectively, in overall PASI score when compared to baseline.
Time frame: Week 50
Population: The population consists of all participants that achieved PASI-75 response by treatment Week 14.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Infliximab 5 mg/kg | Number of Particpants With a PASI-90 or PASI-75 at Week 50 Among Participants With a PASI-75 Response at Week 14 | PASI-75 Response | 205 Participants |
| Infliximab 5 mg/kg | Number of Particpants With a PASI-90 or PASI-75 at Week 50 Among Participants With a PASI-75 Response at Week 14 | PASI-90 Response | 152 Participants |