Clinical Data CIMPASI-1 16-week Results1

• A total of 234 patients with moderate-to-severe chronic plaque psoriasis were randomized in the CIMPASI-1 trial to one of three dosing arms—400 mg every two weeks (n=88), 400 mg at weeks 0, 2, and 4 followed by 200 mg every two weeks (n=95), or placebo every two weeks (n=51).
  
  
• At week 16, the response rate for patients who achieved a PASI 75 was 75.8% for patients receiving the 400 mg dose every two weeks and 66.5% for patients receiving the 200 mg dose every two weeks, compared to 6.5% for patients receiving placebo.
  
  
• The response rate for patients achieving at least a two-point improvement to a final score of clear or almost clear skin on the PGA scale at week 16 was 57.9% for the 400 mg dose-treated patients and 47.0% for the 200 mg dose-treated patients, compared to 4.2% for the patients receiving placebo.
   
• At week 16, the response rate for patients who achieved a PASI 90 was 43.6% for patients receiving the 400 mg dose every two weeks and 35.8% for patients receiving the 200 mg dose every two weeks, compared to 0.4% for the patients receiving placebo.

CIMPASI-2 16-week Results1

• A total of 227 patients with moderate-to-severe chronic plaque psoriasis were randomized in the CIMPASI-2 trial to one of three dosing arms—400 mg every two weeks (n=87), 400 mg at weeks 0, 2, and 4 followed by 200 mg every two weeks (n=91), or placebo every two weeks (n=49).
   
• At week 16, the response rate for patients who achieved a PASI 75 was 82.6% for patients receiving the 400 mg dose every two weeks and 81.4% for patients receiving the 200 mg dose every two weeks, compared to 11.6% for the patients receiving placebo.
  
  
• The response rate for patients achieving at least a two-point improvement to a final score of clear or almost clear skin on the PGA scale at week 16 was 71.6% for the 400 mg dose-treated patients and 66.8% for the 200 mg dose-treated patients, compared to 2.0% for the patients receiving placebo.
   
• At week 16, the response rate for patients who achieved a PASI 90 was 55.4% for patients receiving the 400 mg dose every two weeks and 52.6% for patients receiving the 200 mg dose every two weeks, compared to 4.5% for the patients receiving placebo.    
  
  Additional data reported from a key secondary endpoint also found that patients receiving the 400mg and 200 mg dose reported significant improvements in their quality of life compared to patients who received placebo only. CIMZIA showed a mean improvement from baseline in the Dermatology Life Quality Index (DLQI) score compared to placebo, at both doses in both the CIMPASI-1 (decrease of 10.2 at 400 mg and 9.3 at 200 mg vs. 3.3; p<0.001) and CIMPASI-2 (decrease of 10.0 at 400 mg and 10.4 at 200 mg vs. 3.8; p<0.001) clinical trials, at week 16.A decrease in a patient’s DLQI score translates to overall improved satisfaction in the management of their skin condition. DLQI is a widely used and recognized quality of life measurement instrument frequently used across many dermatologic conditions.
  
  RAPID-PsA Results3,4,5Additionally, three post-hoc data analyses from the RAPID-PsA four-year open label extension study were presented, providing insight into the long-term impact of CIMZIA on psoriatic arthritis (PsA) patients. RAPID-PsA is a Phase 3, multi-center, randomized, double-blind, placebo-controlled study designed to evaluate the efficacy and safety of CIMZIA. The results of RAPID-PsA were:
  • A total of 409 patients with onset active and progressive psoriatic arthritis (PsA) were randomized to one of three dosing arms – to CIMZIA 200 mg every two weeks (n=138), CIMZIA 400 mg every four weeks (n=135), or placebo (n=136) for 24 weeks, followed by dose blind to week 48, and open-label extension to week 216. All patients received a loading dose with CIMZIA 400 mg or placebo at weeks 0, 2, and 4. 
     
  • Eligible patients had adult onset active PsA ≥6 months’ duration as defined by the Classification Criteria for Psoriatic Arthritis (CASPAR) criteria, active psoriatic lesions or a documented history of psoriasis, ≥3 tender and ≥3 swollen joints, erythrocyte sedimentation rate ≥28 mm/hr (Westergren) and/or C-reactive protein greater than the upper limit of normal, and failed ≥1 DMARD (nonbiologic or biologic). 
     
  • For extra-articular manifestations (EAMs) specifically, by week 24, a large proportion of patients with baseline involvement achieved total resolution of the respective EAM (nail psoriasis: 38.5%, enthesitis: 65.2%, dactylitis: 73.8%) Mean scores in all EAMs assessed showed improvements by week 12 and maintained to week 216 for patients completing the study.
     
  • Patients with or without prior anti-TNF exposure experienced improvements in joint and skin manifestations that were maintained over four years. For skin outcomes, these improvements were maintained in patients with and without prior anti-TNF exposure. Additionally, for patients treated with CIMZIA® both with and without concomitant DMARD use, efficacy was maintained over four years.