Trial Outcomes & Findings for Assessment of Long-Term Infliximab for Psoriasis (P05319) (NCT NCT00779675)
NCT ID: NCT00779675
Last Updated: 2015-11-02
Results Overview
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.
COMPLETED
660 participants
Week 50
2015-11-02
Participant Flow
Participant milestones
| Measure |
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).
|
|---|---|
|
Treatment Period
STARTED
|
660
|
|
Treatment Period
COMPLETED
|
328
|
|
Treatment Period
NOT COMPLETED
|
332
|
|
Extended Treatment Period
STARTED
|
193
|
|
Extended Treatment Period
COMPLETED
|
147
|
|
Extended Treatment Period
NOT COMPLETED
|
46
|
Reasons for withdrawal
| Measure |
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).
|
|---|---|
|
Treatment Period
Adverse Event
|
87
|
|
Treatment Period
Treatment Failure
|
80
|
|
Treatment Period
Transferred to Another Study
|
38
|
|
Treatment Period
Lost to Follow-up
|
23
|
|
Treatment Period
Withdrawal by Subject
|
46
|
|
Treatment Period
Protocol Violation
|
54
|
|
Treatment Period
Did Not Meet Protocol Eligibility
|
1
|
|
Treatment Period
Administrative
|
3
|
|
Extended Treatment Period
Reasons unrelated to study treatment
|
9
|
|
Extended Treatment Period
Protocol Violation
|
13
|
|
Extended Treatment Period
Adverse Event
|
6
|
|
Extended Treatment Period
Treatment Failure
|
11
|
|
Extended Treatment Period
Protocol defined clinical event
|
1
|
|
Extended Treatment Period
Lost to Follow-up
|
6
|
Baseline Characteristics
Assessment of Long-Term Infliximab for Psoriasis (P05319)
Baseline characteristics by cohort
| Measure |
Infliximab 5 mg/kg
n=660 Participants
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).
|
|---|---|
|
Age, Continuous
|
46.3 years
STANDARD_DEVIATION 13.5 • n=5 Participants
|
|
Sex: Female, Male
Female
|
230 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
430 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Week 50Population: 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.
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.
Outcome measures
| Measure |
Infliximab 5 mg/kg
n=521 Participants
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).
|
|---|---|
|
Number of Participants With a Psoriasis Area Sensitivity Index (PASI)-75 Response at Week 50
|
296 Participants
|
SECONDARY outcome
Timeframe: Week 50Population: The population consists of all participants that achieved a PASI-90 response at treatment 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.
Outcome measures
| Measure |
Infliximab 5 mg/kg
n=183 Participants
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).
|
|---|---|
|
Number of Participants With a PASI-90 Response at Week 50 Among Participants With a PASI-90 Response at Week 14
|
104 Participants
|
SECONDARY outcome
Timeframe: Week 50Population: The population consists of all participants that achieved PASI-75 response by treatment 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.
Outcome measures
| Measure |
Infliximab 5 mg/kg
n=317 Participants
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).
|
|---|---|
|
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
|
|
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
|
SECONDARY outcome
Timeframe: Week 50Population: The population includes all participants that achieved a PASI-50 response at treatment 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.
Outcome measures
| Measure |
Infliximab 5 mg/kg
n=415 Participants
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).
|
|---|---|
|
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
|
|
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
|
|
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
|
SECONDARY outcome
Timeframe: Week 98Population: The population consists of all participants that achieved PASI-90 response at Week 50 and entered the extended treatment phase.
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.
Outcome measures
| Measure |
Infliximab 5 mg/kg
n=106 Participants
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).
|
|---|---|
|
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 outcome
Timeframe: Week 98Population: The population includes all participants that achieved PASI-50 response at Week 50 and entered the extended treatment phase.
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.
Outcome measures
| Measure |
Infliximab 5 mg/kg
n=158 Participants
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).
|
|---|---|
|
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
|
|
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
|
|
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
|
SECONDARY outcome
Timeframe: Baseline, Week 14, Week 30, Week 50, Week 62, Week 78, Week 98Population: The population consists of all participants with a baseline PASI score and a subsequent score at Week 14, 30, 50, 62, 78,and 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.
Outcome measures
| Measure |
Infliximab 5 mg/kg
n=169 Participants
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).
|
|---|---|
|
Change From Baseline in Mean PASI Score
Week 14 (n=166)
|
-17.3 Score on a Scale
95% Confidence Interval -17.3 • Interval -18.87 to -15.71
|
|
Change From Baseline in Mean PASI Score
Week 30 (n=165)
|
-18.0 Score on a Scale
95% Confidence Interval -18.0 • Interval -19.66 to -16.38
|
|
Change From Baseline in Mean PASI Score
Week 50 (n=165)
|
-18.4 Score on a Scale
95% Confidence Interval -18.4 • Interval -20.01 to -16.74
|
|
Change From Baseline in Mean PASI Score
Week 62 (n=136)
|
-17.8 Score on a Scale
95% Confidence Interval -17.8 • Interval -19.67 to -15.98
|
|
Change From Baseline in Mean PASI Score
Week 78 (n=143)
|
-17.5 Score on a Scale
95% Confidence Interval -17.5 • Interval -19.22 to -15.7
|
|
Change From Baseline in Mean PASI Score
Week 98 (n=142)
|
-17.3 Score on a Scale
95% Confidence Interval -17.3 • Interval -19.06 to -15.55
|
SECONDARY outcome
Timeframe: Week 98Population: 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.
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.
Outcome measures
| Measure |
Infliximab 5 mg/kg
n=141 Participants
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).
|
|---|---|
|
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
|
|
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 outcome
Timeframe: Baseline, Week 50, Week 62, Week 78, Week 98Population: The population consisted of all participants with a DLQI measurement at baseline and at each time point.
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.
Outcome measures
| Measure |
Infliximab 5 mg/kg
n=169 Participants
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).
|
|---|---|
|
Change From Baseline in Mean Dermatology Life Quality Index (DLQI)
Week 50 (n=149)
|
9.8 Score on a Scale
Standard Error 0.61 • Interval -10.98 to -8.56
|
|
Change From Baseline in Mean Dermatology Life Quality Index (DLQI)
Week 62 (n=131)
|
9.0 Score on a Scale
Standard Error 0.77 • Interval -10.54 to -7.49
|
|
Change From Baseline in Mean Dermatology Life Quality Index (DLQI)
Week 78 (n=134)
|
9.7 Score on a Scale
Standard Error 0.69 • Interval -11.07 to -8.32
|
|
Change From Baseline in Mean Dermatology Life Quality Index (DLQI)
Week 98 (n=140)
|
9.4 Score on a Scale
Standard Error 0.70 • Interval -10.78 to -7.99
|
SECONDARY outcome
Timeframe: Week 50, Week 62, Week 78, Week 98Population: The population consisted of all participants with a DLQI measurement at each time point.
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.
Outcome measures
| Measure |
Infliximab 5 mg/kg
n=169 Participants
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).
|
|---|---|
|
Number of Participants With A DLQI Score of 0 or 1 in the Extended Treatment Phase
Week 50, DLQI=0
|
77 Participants
|
|
Number of Participants With A DLQI Score of 0 or 1 in the Extended Treatment Phase
Week 50, DLQI=0 or 1
|
102 Participants
|
|
Number of Participants With A DLQI Score of 0 or 1 in the Extended Treatment Phase
Week 50, DLQI >1
|
51 Participants
|
|
Number of Participants With A DLQI Score of 0 or 1 in the Extended Treatment Phase
Week 50, DLQI Missing
|
16 Participants
|
|
Number of Participants With A DLQI Score of 0 or 1 in the Extended Treatment Phase
Week 62, DLQI=0
|
51 Participants
|
|
Number of Participants With A DLQI Score of 0 or 1 in the Extended Treatment Phase
Week 62, DLQI=0 or 1
|
75 Participants
|
|
Number of Participants With A DLQI Score of 0 or 1 in the Extended Treatment Phase
Week 62, DLQI >1
|
57 Participants
|
|
Number of Participants With A DLQI Score of 0 or 1 in the Extended Treatment Phase
Week 62, DLQI Missing
|
37 Participants
|
|
Number of Participants With A DLQI Score of 0 or 1 in the Extended Treatment Phase
Week 78, DLQI=0
|
57 Participants
|
|
Number of Participants With A DLQI Score of 0 or 1 in the Extended Treatment Phase
Week 78, DLQI=0 or 1
|
80 Participants
|
|
Number of Participants With A DLQI Score of 0 or 1 in the Extended Treatment Phase
Week 78, DLQI >1
|
55 Participants
|
|
Number of Participants With A DLQI Score of 0 or 1 in the Extended Treatment Phase
Week 78, DLQI Missing
|
34 Participants
|
|
Number of Participants With A DLQI Score of 0 or 1 in the Extended Treatment Phase
Week 98, DLQI=0
|
67 Participants
|
|
Number of Participants With A DLQI Score of 0 or 1 in the Extended Treatment Phase
Week 98. DLQI=0 or 1
|
84 Participants
|
|
Number of Participants With A DLQI Score of 0 or 1 in the Extended Treatment Phase
Week 98, DLQI >1
|
57 Participants
|
|
Number of Participants With A DLQI Score of 0 or 1 in the Extended Treatment Phase
Week 98, DLQI Missing
|
28 Participants
|
SECONDARY outcome
Timeframe: Week 98Population: 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.
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.
Outcome measures
| Measure |
Infliximab 5 mg/kg
n=169 Participants
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).
|
|---|---|
|
Number of Participants With a PASI-50, PASI-75, PASI-90, or PASI-100 Response at Week 98
PASI-50
|
129 Participants
|
|
Number of Participants With a PASI-50, PASI-75, PASI-90, or PASI-100 Response at Week 98
PASI-75
|
112 Participants
|
|
Number of Participants With a PASI-50, PASI-75, PASI-90, or PASI-100 Response at Week 98
PASI-90
|
82 Participants
|
|
Number of Participants With a PASI-50, PASI-75, PASI-90, or PASI-100 Response at Week 98
PASI-100
|
35 Participants
|
SECONDARY outcome
Timeframe: Week 50Population: 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.
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.
Outcome measures
| Measure |
Infliximab 5 mg/kg
n=521 Participants
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).
|
|---|---|
|
Number of Participants Who Achieved a PASI-75 Response at Week 50 by Age
Age <65 years (n=469)
|
264 Participants
|
|
Number of Participants Who Achieved a PASI-75 Response at Week 50 by Age
Age >=65 years (n=52)
|
32 Participants
|
SECONDARY outcome
Timeframe: Week 50Population: 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.
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.
Outcome measures
| Measure |
Infliximab 5 mg/kg
n=521 Participants
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).
|
|---|---|
|
Number of Participants Who Achieved a PASI-75 Response at Week 50 by Gender
Male (n=344)
|
199 Participants
|
|
Number of Participants Who Achieved a PASI-75 Response at Week 50 by Gender
Female (n=177)
|
97 Participants
|
SECONDARY outcome
Timeframe: Week 50Population: 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.
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.
Outcome measures
| Measure |
Infliximab 5 mg/kg
n=521 Participants
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).
|
|---|---|
|
Number of Participants Who Achieved a PASI-75 Response at Week 50 by Race
Caucasian (n=436)
|
235 Participants
|
|
Number of Participants Who Achieved a PASI-75 Response at Week 50 by Race
Non-Caucasian (n=85)
|
61 Participants
|
SECONDARY outcome
Timeframe: Week 50Population: 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.
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.
Outcome measures
| Measure |
Infliximab 5 mg/kg
n=521 Participants
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).
|
|---|---|
|
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
|
|
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 outcome
Timeframe: Week 50Population: 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.
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..
Outcome measures
| Measure |
Infliximab 5 mg/kg
n=521 Participants
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).
|
|---|---|
|
Number of Participants Who Achieved a PASI-75 Response at Week 50 by PASI Score at Baseline
Baseline PASI <12 (n=167)
|
77 Participants
|
|
Number of Participants Who Achieved a PASI-75 Response at Week 50 by PASI Score at Baseline
Baseline PASI >=12 (n=354)
|
219 Participants
|
Adverse Events
Infliximab 5 mg/kg
Serious adverse events
| Measure |
Infliximab 5 mg/kg
n=659 participants at risk
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).
|
|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
0.15%
1/659 • Number of events 1 • Up to Week 98
|
|
Blood and lymphatic system disorders
Microcytic Anaemia
|
0.15%
1/659 • Number of events 1 • Up to Week 98
|
|
Cardiac disorders
Cardiac Failure
|
0.15%
1/659 • Number of events 1 • Up to Week 98
|
|
Cardiac disorders
Cardiac Failure Congestive
|
0.15%
1/659 • Number of events 1 • Up to Week 98
|
|
Cardiac disorders
Cardiopulmonary Failure
|
0.15%
1/659 • Number of events 1 • Up to Week 98
|
|
Cardiac disorders
Coronary Artery Stenosis
|
0.15%
1/659 • Number of events 1 • Up to Week 98
|
|
Cardiac disorders
Left Ventricular Failure
|
0.15%
1/659 • Number of events 1 • Up to Week 98
|
|
Cardiac disorders
Myocardial Infarction
|
0.15%
1/659 • Number of events 1 • Up to Week 98
|
|
Endocrine disorders
Thyroiditis
|
0.15%
1/659 • Number of events 1 • Up to Week 98
|
|
Gastrointestinal disorders
Diarrhoea
|
0.15%
1/659 • Number of events 1 • Up to Week 98
|
|
Gastrointestinal disorders
Gastrointestinal Disorder
|
0.15%
1/659 • Number of events 1 • Up to Week 98
|
|
Gastrointestinal disorders
Pancreatitis Acute
|
0.15%
1/659 • Number of events 1 • Up to Week 98
|
|
General disorders
Non-Cardiac Chest Pain
|
0.15%
1/659 • Number of events 1 • Up to Week 98
|
|
General disorders
Drug Interaction
|
0.15%
1/659 • Number of events 1 • Up to Week 98
|
|
Hepatobiliary disorders
Cytolytic Hepatitis
|
0.30%
2/659 • Number of events 2 • Up to Week 98
|
|
Hepatobiliary disorders
Gallbladder Polyp
|
0.15%
1/659 • Number of events 1 • Up to Week 98
|
|
Hepatobiliary disorders
Hepatotoxicity
|
0.15%
1/659 • Number of events 1 • Up to Week 98
|
|
Hepatobiliary disorders
Hepatitis
|
0.15%
1/659 • Number of events 1 • Up to Week 98
|
|
Immune system disorders
Anaphylactic Reaction
|
0.15%
1/659 • Number of events 1 • Up to Week 98
|
|
Immune system disorders
Drug Hypersensitivity
|
0.15%
1/659 • Number of events 1 • Up to Week 98
|
|
Immune system disorders
Hypersensitivity
|
0.15%
1/659 • Number of events 1 • Up to Week 98
|
|
Infections and infestations
Bronchitis
|
0.15%
1/659 • Number of events 1 • Up to Week 98
|
|
Infections and infestations
Bronchopneumonia
|
0.15%
1/659 • Number of events 1 • Up to Week 98
|
|
Infections and infestations
Cellulitis
|
0.30%
2/659 • Number of events 2 • Up to Week 98
|
|
Infections and infestations
Clostridial Infection
|
0.15%
1/659 • Number of events 1 • Up to Week 98
|
|
Infections and infestations
Enterocolitis Infectious
|
0.15%
1/659 • Number of events 1 • Up to Week 98
|
|
Infections and infestations
Gastroenteritis
|
0.15%
1/659 • Number of events 1 • Up to Week 98
|
|
Infections and infestations
Gastroenteritis Salmonella
|
0.15%
1/659 • Number of events 1 • Up to Week 98
|
|
Infections and infestations
Herpes Zoster
|
0.15%
1/659 • Number of events 1 • Up to Week 98
|
|
Infections and infestations
Lymph Node Tuberculosis
|
0.15%
1/659 • Number of events 1 • Up to Week 98
|
|
Infections and infestations
Pneumonia
|
0.15%
1/659 • Number of events 2 • Up to Week 98
|
|
Infections and infestations
Tuberculosis
|
0.30%
2/659 • Number of events 2 • Up to Week 98
|
|
Injury, poisoning and procedural complications
Femoral Neck Fracture
|
0.15%
1/659 • Number of events 1 • Up to Week 98
|
|
Injury, poisoning and procedural complications
Head Injury
|
0.15%
1/659 • Number of events 1 • Up to Week 98
|
|
Injury, poisoning and procedural complications
Infusion Related Reaction
|
0.30%
2/659 • Number of events 2 • Up to Week 98
|
|
Injury, poisoning and procedural complications
Overdose
|
0.15%
1/659 • Number of events 1 • Up to Week 98
|
|
Injury, poisoning and procedural complications
Rib Fracture
|
0.15%
1/659 • Number of events 1 • Up to Week 98
|
|
Injury, poisoning and procedural complications
Upper Limb Fracture
|
0.15%
1/659 • Number of events 1 • Up to Week 98
|
|
Investigations
Hepatic Enzyme Increased
|
0.15%
1/659 • Number of events 1 • Up to Week 98
|
|
Investigations
Tuberculin Test Positive
|
0.15%
1/659 • Number of events 1 • Up to Week 98
|
|
Metabolism and nutrition disorders
Diabetes Mellitus
|
0.30%
2/659 • Number of events 2 • Up to Week 98
|
|
Musculoskeletal and connective tissue disorders
Back Pain
|
0.30%
2/659 • Number of events 2 • Up to Week 98
|
|
Musculoskeletal and connective tissue disorders
Muscle Spasms
|
0.15%
1/659 • Number of events 1 • Up to Week 98
|
|
Musculoskeletal and connective tissue disorders
Psoriatic Arthropathy
|
0.15%
1/659 • Number of events 2 • Up to Week 98
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Adenocarcinoma
|
0.15%
1/659 • Number of events 1 • Up to Week 98
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung Neoplasm Malignant
|
0.30%
2/659 • Number of events 2 • Up to Week 98
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant Peritoneal Neoplasm
|
0.15%
1/659 • Number of events 1 • Up to Week 98
|
|
Nervous system disorders
Basal Ganglia Haemorrhage
|
0.15%
1/659 • Number of events 1 • Up to Week 98
|
|
Nervous system disorders
Intraventricular Haemorrhage
|
0.15%
1/659 • Number of events 1 • Up to Week 98
|
|
Nervous system disorders
Ischaemic Stroke
|
0.15%
1/659 • Number of events 1 • Up to Week 98
|
|
Nervous system disorders
Myoclonus
|
0.15%
1/659 • Number of events 1 • Up to Week 98
|
|
Pregnancy, puerperium and perinatal conditions
Pregnancy
|
0.30%
2/659 • Number of events 2 • Up to Week 98
|
|
Psychiatric disorders
Depression
|
0.15%
1/659 • Number of events 1 • Up to Week 98
|
|
Renal and urinary disorders
Enuresis
|
0.15%
1/659 • Number of events 1 • Up to Week 98
|
|
Renal and urinary disorders
Renal Colic
|
0.15%
1/659 • Number of events 1 • Up to Week 98
|
|
Reproductive system and breast disorders
Ovarian Cyst
|
0.15%
1/659 • Number of events 1 • Up to Week 98
|
|
Respiratory, thoracic and mediastinal disorders
Lung Disorder
|
0.15%
1/659 • Number of events 1 • Up to Week 98
|
|
Skin and subcutaneous tissue disorders
Acute Generalised Exanthematous Pustulosis
|
0.30%
2/659 • Number of events 2 • Up to Week 98
|
|
Skin and subcutaneous tissue disorders
Erythrodermic Psoriasis
|
0.15%
1/659 • Number of events 1 • Up to Week 98
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
0.46%
3/659 • Number of events 3 • Up to Week 98
|
|
Social circumstances
Pregnancy of Partner
|
0.15%
1/659 • Number of events 1 • Up to Week 98
|
|
Surgical and medical procedures
Inguinal Hernia Repair
|
0.15%
1/659 • Number of events 1 • Up to Week 98
|
|
Surgical and medical procedures
Umbilical Hernia Repair
|
0.15%
1/659 • Number of events 1 • Up to Week 98
|
|
Vascular disorders
Aortic Aneurysm
|
0.15%
1/659 • Number of events 1 • Up to Week 98
|
|
Blood and lymphatic system disorders
Pancytopenia
|
0.15%
1/659 • Number of events 1 • Up to Week 98
|
|
Cardiac disorders
Acute Myocardial Infarction
|
0.15%
1/659 • Number of events 1 • Up to Week 98
|
|
Gastrointestinal disorders
Umbilical Hernia
|
0.15%
1/659 • Number of events 1 • Up to Week 98
|
|
Investigations
Liver Function Test Abnormal
|
0.15%
1/659 • Number of events 1 • Up to Week 98
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Hepatic Neoplasm Malignant
|
0.15%
1/659 • Number of events 1 • Up to Week 98
|
|
Renal and urinary disorders
Bladder Tamponade
|
0.15%
1/659 • Number of events 1 • Up to Week 98
|
|
Reproductive system and breast disorders
Prostatitis
|
0.15%
1/659 • Number of events 1 • Up to Week 98
|
|
Skin and subcutaneous tissue disorders
Erythema Multiforme
|
0.15%
1/659 • Number of events 1 • Up to Week 98
|
|
Skin and subcutaneous tissue disorders
Psoriasis
|
0.15%
1/659 • Number of events 1 • Up to Week 98
|
|
Surgical and medical procedures
Hip Arthroplasty
|
0.15%
1/659 • Number of events 1 • Up to Week 98
|
Other adverse events
Adverse event data not reported
Additional Information
Senior Vice President, Global Clinical Development
Merck Sharp & Dohme Corp.
Results disclosure agreements
- Principal investigator is a sponsor employee The investigator agrees to provide the sponsor 45 days prior to submission for publication or presentation, review copies of abstracts or manuscripts for publication. The sponsor shall have the right to review and comment with respect to publications, abstracts, slides, and manuscripts and the right to review and comment on the data.
- Publication restrictions are in place
Restriction type: OTHER