CIMPASI-1 & CIMPASI-2 Study Design18

 
 
 
  1. Patients may have had exposure to >1 prior biologic but ≤2 per exclusion criteria. Primary nonresponders were excluded.
  2. Loading dose of CIMZIA 400 mg Q2W at Weeks 0, 2, and 4 or Weeks 16, 18, and 20.
  3. Subjects received 400 mg of CIMZIA at Weeks 0, 2, and 4, followed by 200 mg every other week.
  4. 1 patient in the CIMZIA 400 mg Q2W group in CIMPASI-2 had prior exposure to ≥3 biologics, which was a protocol violation.
  5. Study design was the same for both studies; CIMPASI-1, n=234; CIMPASI-2, n=227.

LD, loading dose; PASI, Psoriasis Area and Severity Index; PGA, Physician’s Global Assessment; Q2W, every 2 weeks.

CIMPASI-1 (234 subjects) and CIMPASI-2 (227 subjects) randomized subjects to placebo, CIMZIA 200 mg every other week (following a loading dose of CIMZIA 400 mg at Weeks 0, 2, and 4), or CIMZIA 400 mg every other week. CIMPASI-1 and CIMPASI-2 assessed the co-primary endpoints of the proportion of patients who achieved a PASI 75 and PGA of “clear” or “almost clear” with at least a 2-point improvement on a 5-point scale (0-4) at Week 16. Other evaluated outcomes included PASI 90 at Week 16 and maintenance of efficacy to Week 48.