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NCT02326272 · OUTCOME

Proportion of Participants Who Achieve a Psoriasis Activity and Severity Index (PASI75) Response at Week 16

A Study to Evaluate the Efficacy and Safety of Two Dose Levels of Certolizumab Pegol (CZP) in Subjects With Plaque Psoriasis (PSO) · Source last updated 2019-10-03

Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.

Measure
NUMBER
Unit
percentage of participants
Interval / dispersion
Not reported
Time frame
Week 16

What was measured

The PASI75 response assessments are based on at least 75% improvement in the PASI score from Baseline. This is a scoring system that averages the redness, thickness, and scaliness of the psoriatic lesions (on a 0-4 scale) and weights the resulting score by the area of skin involved. Body divided into 4 areas: head, arms, trunk to groin, and legs to top of buttocks. Assignment of an average score for the redness, thickness, and scaling for each of the 4 body areas with a score of 0 (clear) to 4 (very marked). Determining the percentage of skin covered with PSO for each of the body areas and converting to a 0 to 6 scale. Final PASI= average redness, thickness, and scaliness of the psoriatic skin lesions, multiplied by the involved psoriasis area score of the respective section, and weighted by the percentage of the person's affected skin for the respective section. The minimum possible PASI score is 0=no disease, the maximum score is 72=maximal disease.

Analysis population: The Randomized Set (RS) included all participants randomized into the study. Missing data were handled using the Markov Chain Monte Carlo (MCMC) method for multiple imputation.

Groups in this outcome

Placebo Q2W (RS)

Placebo sc injection Q2W. Treatment received from Week 16 - 48 was based on initial treatment and response to treatment: * PASI50 responders at Week 16, who did not achieve a PASI75 response at Week 16 received CZP 400 mg at Weeks 16, 18 and 20 (loading doses) followed by CZP 200 mg Q2W starting at Week 22. * PASI75 responders at Week 16 continued to receive Placebo. * PASI50 non-responders at Week 16 were removed from blinded study medication and escaped to unblinded CZP 400 mg Q2W. Participants who received unblinded CZP 400 mg Q2W for 16 weeks and did not achieve a PASI50 response were withdrawn from the study. * PASI50 non-responders at Week 32 or a later time point were withdrawn from the study. Participants who completed the Maintenance Period (with PASI50 response at Week 48) entered the OLE Period on CZP 200 mg Q2W. Week 48 completers in the escape arm continued to receive CZP 400 mg Q2W or may have switched to CZP 200 mg Q2W. Participants formed the Randomized Set (RS).

CZP 200 mg Q2W (RS)

CZP 400 mg at Weeks 0, 2, 4, followed by CZP 200 mg Q2W from Week 6 to Week 14. Treatment received from Week 16 - 48 was based on initial treatment and response to treatment: * PASI50 responders at Week 16 continued to receive CZP 200 mg Q2W. * PASI50 non-responders at Week 16 were removed from blinded study medication and escaped to unblinded CZP 400 mg Q2W. Participants who received unblinded CZP 400 mg Q2W for 16 weeks and did not achieve a PASI50 response were withdrawn from the study. * PASI50 non-responders at Week 32 or a later time point were withdrawn from the study. Participants who completed the Maintenance Period (with PASI50 response at Week 48) entered the OLE Period on CZP 200 mg Q2W. Week 48 completers in the escape arm continued to receive CZP 400 mg Q2W or may have switched to CZP 200 mg Q2W. Depending on PASI50 or PASI75 responses at Week 60 or a later time point, participants may have switched to CZP 400 mg Q2W or withdrew from the study. Participants formed the RS.

CZP 400 mg Q2W (RS)

CZP 400 mg Q2W through Week 14. Treatment received from Week 16 - 48 was based on initial treatment and response to treatment: * PASI50 responders at Week 16 continued to receive CZP 400 mg Q2W. * PASI50 non-responders at Week 16 were removed from blinded study medication and escaped to unblinded CZP 400 mg Q2W. Participants who received unblinded CZP 400 mg Q2W for 16 weeks and did not achieve a PASI50 response were withdrawn from the study. * PASI50 non-responders at Week 32 or a later time point were withdrawn from the study. Participants who completed the Maintenance Period (with PASI50 response at Week 48) entered the OLE Period on CZP 200 mg Q2W. Week 48 completers in the escape arm continued to receive CZP 400 mg Q2W or may have switched to CZP 200 mg Q2W. Participants who achieved a PASI75 response during the OLE Period may have switched to CZP 200 mg Q2W. Participants formed the RS.

Group identifiers and denominators belong to this outcome only. They may differ in another outcome or in safety reporting.

Analysis denominator · Participants

GroupSource count
Placebo Q2W (RS)49
CZP 200 mg Q2W (RS)91
CZP 400 mg Q2W (RS)87

Reported measurements

Source class 1
Values in percentage of participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Placebo Q2W (RS)11.6Not reportedNot reportedNot reportedNot reported
CZP 200 mg Q2W (RS)81.4Not reportedNot reportedNot reportedNot reported
CZP 400 mg Q2W (RS)82.6Not reportedNot reportedNot reportedNot reported

Source statistical analyses

Group order, estimate direction, methods and comments are retained. No treatment ranking is inferred.

  1. ci Lower Limit
    9.965
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    97.5
    ci Upper Limit
    111.983
    group Description
    The statistical analysis of the co-primary efficacy variables and key secondary efficacy variables accounted for multiplicity by using a fixed sequence testing procedure.
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY
    p Value
    <0.0001
    p Value Comment
    The p-value for the primary analysis was evaluated at a 2-sided significance level of 0.025 for each CZP dose versus (vs) placebo (PBO).
    param Type
    Odds Ratio (OR)
    param Value
    33.405
    statistical Comment
    Estimated responder rate, odds ratios, CIs, p-values based on a logistic regression model with factors for treatment, region, prior biologic exposure.
    statistical Method
    Regression, Logistic
  2. ci Lower Limit
    57.12
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    82.36
    group Description
    The statistical analysis of the co-primary efficacy variables and key secondary efficacy variables accounted for multiplicity by using a fixed sequence testing procedure.
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY
    param Type
    Estimated difference in responder rate
    param Value
    69.7
    statistical Comment
    Estimated responder rate, odds ratios, CIs, p-values based on a logistic regression model with factors for treatment, region, prior biologic exposure.
    statistical Method
    Regression, Logistic
  3. ci Lower Limit
    10.686
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    97.5
    ci Upper Limit
    122.713
    group Description
    The statistical analysis of the co-primary efficacy variables and key secondary efficacy variables accounted for multiplicity by using a fixed sequence testing procedure.
    group Ids
    1. OG000
    2. OG002
    non Inferiority Type
    SUPERIORITY
    p Value
    <0.0001
    p Value Comment
    The p-value for the primary analysis was evaluated at a 2-sided significance level of 0.025 for each CZP dose vs PBO.
    param Type
    Odds Ratio (OR)
    param Value
    36.212
    statistical Comment
    Estimated responder rate, odds ratios, CIs, p-values based on a logistic regression model with factors for treatment, region, prior biologic exposure.
    statistical Method
    Regression, Logistic
  4. ci Lower Limit
    58.47
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    83.43
    group Description
    The statistical analysis of the co-primary efficacy variables and key secondary efficacy variables accounted for multiplicity by using a fixed sequence testing procedure.
    group Ids
    1. OG000
    2. OG002
    non Inferiority Type
    SUPERIORITY
    param Type
    Estimated difference in responder rate
    param Value
    71.0
    statistical Comment
    Estimated responder rate, odds ratios, CIs, p-values based on a logistic regression model with factors for treatment, region, prior biologic exposure.
    statistical Method
    Regression, Logistic
Complete source fields
analyses
  1. ci Lower Limit
    9.965
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    97.5
    ci Upper Limit
    111.983
    group Description
    The statistical analysis of the co-primary efficacy variables and key secondary efficacy variables accounted for multiplicity by using a fixed sequence testing procedure.
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY
    p Value
    <0.0001
    p Value Comment
    The p-value for the primary analysis was evaluated at a 2-sided significance level of 0.025 for each CZP dose versus (vs) placebo (PBO).
    param Type
    Odds Ratio (OR)
    param Value
    33.405
    statistical Comment
    Estimated responder rate, odds ratios, CIs, p-values based on a logistic regression model with factors for treatment, region, prior biologic exposure.
    statistical Method
    Regression, Logistic
  2. ci Lower Limit
    57.12
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    82.36
    group Description
    The statistical analysis of the co-primary efficacy variables and key secondary efficacy variables accounted for multiplicity by using a fixed sequence testing procedure.
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY
    param Type
    Estimated difference in responder rate
    param Value
    69.7
    statistical Comment
    Estimated responder rate, odds ratios, CIs, p-values based on a logistic regression model with factors for treatment, region, prior biologic exposure.
    statistical Method
    Regression, Logistic
  3. ci Lower Limit
    10.686
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    97.5
    ci Upper Limit
    122.713
    group Description
    The statistical analysis of the co-primary efficacy variables and key secondary efficacy variables accounted for multiplicity by using a fixed sequence testing procedure.
    group Ids
    1. OG000
    2. OG002
    non Inferiority Type
    SUPERIORITY
    p Value
    <0.0001
    p Value Comment
    The p-value for the primary analysis was evaluated at a 2-sided significance level of 0.025 for each CZP dose vs PBO.
    param Type
    Odds Ratio (OR)
    param Value
    36.212
    statistical Comment
    Estimated responder rate, odds ratios, CIs, p-values based on a logistic regression model with factors for treatment, region, prior biologic exposure.
    statistical Method
    Regression, Logistic
  4. ci Lower Limit
    58.47
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    83.43
    group Description
    The statistical analysis of the co-primary efficacy variables and key secondary efficacy variables accounted for multiplicity by using a fixed sequence testing procedure.
    group Ids
    1. OG000
    2. OG002
    non Inferiority Type
    SUPERIORITY
    param Type
    Estimated difference in responder rate
    param Value
    71.0
    statistical Comment
    Estimated responder rate, odds ratios, CIs, p-values based on a logistic regression model with factors for treatment, region, prior biologic exposure.
    statistical Method
    Regression, Logistic
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        11.6
      2. group Id
        OG001
        value
        81.4
      3. group Id
        OG002
        value
        82.6
denoms
  1. counts
    1. group Id
      OG000
      value
      49
    2. group Id
      OG001
      value
      91
    3. group Id
      OG002
      value
      87
    units
    Participants
description
The PASI75 response assessments are based on at least 75% improvement in the PASI score from Baseline. This is a scoring system that averages the redness, thickness, and scaliness of the psoriatic lesions (on a 0-4 scale) and weights the resulting score by the area of skin involved. Body divided into 4 areas: head, arms, trunk to groin, and legs to top of buttocks. Assignment of an average score for the redness, thickness, and scaling for each of the 4 body areas with a score of 0 (clear) to 4 (very marked). Determining the percentage of skin covered with PSO for each of the body areas and converting to a 0 to 6 scale. Final PASI= average redness, thickness, and scaliness of the psoriatic skin lesions, multiplied by the involved psoriasis area score of the respective section, and weighted by the percentage of the person's affected skin for the respective section. The minimum possible PASI score is 0=no disease, the maximum score is 72=maximal disease.
groups
  1. description
    Placebo sc injection Q2W. Treatment received from Week 16 - 48 was based on initial treatment and response to treatment: * PASI50 responders at Week 16, who did not achieve a PASI75 response at Week 16 received CZP 400 mg at Weeks 16, 18 and 20 (loading doses) followed by CZP 200 mg Q2W starting at Week 22. * PASI75 responders at Week 16 continued to receive Placebo. * PASI50 non-responders at Week 16 were removed from blinded study medication and escaped to unblinded CZP 400 mg Q2W. Participants who received unblinded CZP 400 mg Q2W for 16 weeks and did not achieve a PASI50 response were withdrawn from the study. * PASI50 non-responders at Week 32 or a later time point were withdrawn from the study. Participants who completed the Maintenance Period (with PASI50 response at Week 48) entered the OLE Period on CZP 200 mg Q2W. Week 48 completers in the escape arm continued to receive CZP 400 mg Q2W or may have switched to CZP 200 mg Q2W. Participants formed the Randomized Set (RS).
    id
    OG000
    title
    Placebo Q2W (RS)
  2. description
    CZP 400 mg at Weeks 0, 2, 4, followed by CZP 200 mg Q2W from Week 6 to Week 14. Treatment received from Week 16 - 48 was based on initial treatment and response to treatment: * PASI50 responders at Week 16 continued to receive CZP 200 mg Q2W. * PASI50 non-responders at Week 16 were removed from blinded study medication and escaped to unblinded CZP 400 mg Q2W. Participants who received unblinded CZP 400 mg Q2W for 16 weeks and did not achieve a PASI50 response were withdrawn from the study. * PASI50 non-responders at Week 32 or a later time point were withdrawn from the study. Participants who completed the Maintenance Period (with PASI50 response at Week 48) entered the OLE Period on CZP 200 mg Q2W. Week 48 completers in the escape arm continued to receive CZP 400 mg Q2W or may have switched to CZP 200 mg Q2W. Depending on PASI50 or PASI75 responses at Week 60 or a later time point, participants may have switched to CZP 400 mg Q2W or withdrew from the study. Participants formed the RS.
    id
    OG001
    title
    CZP 200 mg Q2W (RS)
  3. description
    CZP 400 mg Q2W through Week 14. Treatment received from Week 16 - 48 was based on initial treatment and response to treatment: * PASI50 responders at Week 16 continued to receive CZP 400 mg Q2W. * PASI50 non-responders at Week 16 were removed from blinded study medication and escaped to unblinded CZP 400 mg Q2W. Participants who received unblinded CZP 400 mg Q2W for 16 weeks and did not achieve a PASI50 response were withdrawn from the study. * PASI50 non-responders at Week 32 or a later time point were withdrawn from the study. Participants who completed the Maintenance Period (with PASI50 response at Week 48) entered the OLE Period on CZP 200 mg Q2W. Week 48 completers in the escape arm continued to receive CZP 400 mg Q2W or may have switched to CZP 200 mg Q2W. Participants who achieved a PASI75 response during the OLE Period may have switched to CZP 200 mg Q2W. Participants formed the RS.
    id
    OG002
    title
    CZP 400 mg Q2W (RS)
param Type
NUMBER
population Description
The Randomized Set (RS) included all participants randomized into the study. Missing data were handled using the Markov Chain Monte Carlo (MCMC) method for multiple imputation.
reporting Status
POSTED
time Frame
Week 16
title
Proportion of Participants Who Achieve a Psoriasis Activity and Severity Index (PASI75) Response at Week 16
type
PRIMARY
unit Of Measure
percentage of participants

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Preserved source evidence · Not medical advice