Proportion of Subjects Who Achieve a Physician's Global Assessment (PGA) Clear or Almost Clear Response (With at Least 2 Category Improvement) at Week 12

Placebo Q2W (RS)

Placebo subcutaneous (sc) injections every 2 weeks (Q2W) through Week 14. Treatment received from Week 16-48 is based on initial treatment and response to treatment: •PASI75 responders at Week 16 continued to receive blinded Placebo. PASI75 non-responders at Week 16 were removed from blinded study medication and escaped to Certolizumab pegol (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 Participants who received unblinded CZP 400 mg Q2W for 16 weeks and did not achieve a PASI50 response were withdrawn from the study. Participants could enter a 96-week open-label extension period after completing the Maintenance Period (Weeks 16-48) and receive CZP under certain conditions. Participants formed the Randomized Set (RS).

Etanercept (RS)

Etanercept (ETN) 50 mg subcutaneous (sc) injections twice per week throughout Week 11.5. •PASI75 responders at Week 16 were re-randomized to either CZP (loading dose of 400 mg at Weeks 16, 18, and 20 followed by 200 mg Q2W) or Placebo Q2W. Participants who did not achieve a PASI75 response at Week 16 escaped to 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 Participants who received unblinded CZP 400 mg Q2W for 16 weeks and did not achieve a PASI50 response were withdrawn from the study. Participants could enter a 96-week open-label extension period after completing the Maintenance Period and receive CZP under certain conditions. Participants formed the Randomized Set (RS).

CZP 200 mg Q2W (RS)

CZP 400 mg injections at Weeks 0, 2, 4, followed by CZP 200 mg every 2 weeks (Q2W) from Week 6 to Week 14. Treatment received from Week 16-48 is based on initial treatment and response to treatment: •PASI75 responders at Week 16 were re-randomized to receive either CZP 200 mg Q2W or CZP 400 mg every 4 weeks (Q4W); with Placebo administered on alternate dosing weeks to maintain the blind) Or Placebo Q2W. Participants who did not achieve a PASI75 response at Week 16 were removed from blinded study medication and escaped to 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 Participants who received unblinded CZP 400 mg Q2W for 16 weeks and did not achieve a PASI50 response were withdrawn from the study. Participants could enter a 96-week open-label extension period after completing the Maintenance Period and receive CZP under certain conditions. Participants formed the Randomized Set (RS).

CZP 400 mg Q2W (RS)

CZP 400 mg injections every 2 weeks (Q2W) through Week 14. Treatment received from Week 16-48 is based on initial treatment and response to treatment: •PASI75 responders at Week 16 were re-randomized to CZP 200 mg Q2W or CZP 400 mg Q2W or Placebo Q2W. Participants who did not achieve a PASI75 response at Week 16 were removed from blinded study medication and escaped to 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. Participants could enter a 96-week open-label extension period after completing the Maintenance Period and receive CZP under certain conditions. Participants formed the Randomized Set (RS).

Analysis denominator · Participants

1. ci Lower Limit

   39.33

   ci Num Sides

   TWO_SIDED

   ci Pct Value

   95

   ci Upper Limit

   57.63

   estimate Comment

   Estimate and 95 % CI for difference in proportion of responders for CZP 400 mg Q2W (RS) versus Placebo Q2W (RS).

   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. OG003

   non Inferiority Type

   SUPERIORITY

   param Type

   Estimated difference in responder rate

   param Value

   48.5

   statistical Comment

   Estimated responder rate, 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

   28.88

   ci Num Sides

   TWO_SIDED

   ci Pct Value

   95

   ci Upper Limit

   46.96

   estimate Comment

   Estimate and 95 % CI for difference in proportion of responders for CZP 200 mg Q2W (RS) versus Placebo Q2W (RS).

   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

   37.9

   statistical Comment

   Estimated responder rate, 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

   7.787

   ci Num Sides

   TWO_SIDED

   ci Pct Value

   95

   ci Upper Limit

   404.555

   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. OG003

   non Inferiority Type

   SUPERIORITY

   p Value

   <0.0001

   p Value Comment

   The p-value is evaluated at a 2-sided significance level for CZP 400 mg vs. PBO

   param Type

   Odds Ratio (OR)

   param Value

   56.129

   statistical Comment

   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

   5.061

   ci Num Sides

   TWO_SIDED

   ci Pct Value

   95

   ci Upper Limit

   264.196

   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

   =0.0004

   p Value Comment

   The p-value is evaluated at a 2-sided significance level for CZP 200 mg vs. PBO

   param Type

   Odds Ratio (OR)

   param Value

   36.566

   statistical Comment

   Odds ratios, CIs, p-values based on a logistic regression model with factors for treatment, region, prior biologic exposure.

   statistical Method

   Regression, Logistic