POOLED PASI RESPONDER RATES

Week 16 pooled PASI responder rates were durable to Week 481,5,18

Durability of PASI 75 and PASI 90 responder ratesa

Pooled PASI responder rates from CIMPASI-1 and CIMPASI-2

  1. Pooled from CIMPASI-1 and CIMPASI-2. Randomized set (Week 0–16); maintenance set (Week 16–48). Missing data were imputed using multiple imputation based on the MCMC method. PASI 50 nonresponders at Weeks 16, 32, or 40 were imputed as nonresponders at all subsequent time points. All other missing data were imputed using multiple imputation (MCMC method).
  2. Placebo responder rate at Week 16 was 7.5% for PASI 75. Placebo responder rate was 1.6% at Week 16 for PASI 90.
  3. Subjects received 400 mg of CIMZIA at Weeks 0, 2, and 4, followed by 200 mg every other week.

~8 of 10 patients

achieved PASI 75 at Week 16 at the recommended dose of 400 mg Q2W5

Approximately half of patients

achieved PASI 90 at Week 16 at the recommended dose of 400 mg Q2W5

Week 16 individual trial results1

CIMPASI-1 PASI 75: 400 mg, 200 mg, Placebo (75%, 65%, 7%)

CIMPASI-2 PASI 75: 400 mg, 200 mg, Placebo (82%, 81%, 13%)

Individual trial co-primary endpoints of PASI 75 and PGA 0/1 at Week 16 were statistically significant versus placebo at Week 16 at both doses1

Primary/key secondary endpoints at Week 16 across 2 pivotal trials1a

 
CIMPASI-1b
CIMZIA
400 mg Q2W
(N=88)
CIMZIA
200 mg Q2Wd
(N=95)
Placebo
(N=51)
PGA 0/1c
55% 45% 4%
PASI 75
75% 65% 7%
PASI 90
44% 36% 0%
CIMPASI-2b
  CIMZIA
400 mg Q2W
(N=87)
CIMZIA
200 mg Q2Wd
(N=91)
Placebo
(N=49)
PGA 0/1c
65% 61% 3%
PASI 75
82% 81% 13%
PASI 90
52% 50% 5%
 

Based on a post hoc subgroup analysis in subjects with moderate to severe psoriasis, stratified by =90 kg or >90 kg, subjects with both lower body weight and lower disease severity may achieve an acceptable response with CIMZIA 200 mg.

  1. Missing data were imputed using multiple imputation based on the MCMC method.
  2. The co-primary efficacy endpoints at Week 16 in CIMPASI-1 and CIMPASI-2 were PASI 75 and PGA 0 or 1.
  3. PGA responder defined as PGA “clear” or “almost clear” with =2-category improvement on a 5-point scale (0-4).
  4. Subjects received 400 mg of CIMZIA at Weeks 0, 2, and 4, followed by 200 mg every other week.

Pooled PGA 0/1 responses were durable to Week 481,5,18

Pooled PGA 0/1 responder ratesa,b

pooled responder rates graph

Randomized set (Weeks 0 to 16); Maintenance set (Weeks 16 to 48). PASI 50 nonresponders at Weeks 16, 32, or 40 were imputed as nonresponders at all subsequent time points. All other missing data were imputed using multiple imputation (Markov Chain Monte Carlo method).

  1. Pooled responder rates from CIMPASI-1 and CIMPASI-2.
  2. PGA responder defined as PGA “clear” or “almost clear” with =2-category improvement on a 5-point scale (0-4).
  3. Subjects received 400 mg of CIMZIA at Weeks 0, 2, and 4, followed by 200 mg every other week.
  4. PGA 0/1 is a co-primary endpoint at Week 16 for CIMPASI-1 and CIMPASI-2.

MCMC, Markov Chain Monte Carlo; PASI, Psoriasis Area and Severity Index; PGA, Physician Global Assessment; Q2W, every 2 weeks.