CIMZIA® (certolizumab pegol) can make a difference, even in PsA and RA patients with previous TNF inhibitor experience

In the PsA study, CIMZIA delivered consistent results regardless of prior TNF inhibitor exposure1,5,10

RAPID-PsA STUDY
ACR20 response rates at week 121,5,10

  • Primary efficacy measure was ACR20 response at week 12 for RAPID-PsA1,10
In the RAPID-PsA Study, ACR20 response at week 12 for patients overall (primary endpoint) was 55% in the CIMZIA 200 mg combined doses (200 mg q2w + 400 mg q4w) group (n=273) compared with 24% for placebo q2w (n=136) (P<0.001). ACR20 response at week 12 for patients with prior TNF inhibitor experience was 54% in the CIMZIA 200 mg group (n=54) compared with 15% for placebo (n=26) (P<0.001). Reference: (1) CIMZIA® [prescribing information], Smyrna, GA: UCB, Inc.; 2013. (5) Data on file. UCB, Inc.; Smyrna, GA. (10) Mease PJ, Fleischmann R, Deodhar AA, et al. Effect of certolizumab pegol on signs and symptoms in patients with psoriatic arthritis: 24-week results of a phase 3 double-blind randomised placebo-controlled study (RAPID-PsA). Ann Rheum Dis. 2014;73:48-55.
  • ITT-NRI: intent-to-treat nonresponder imputation.
  • Prespecified secondary analysis of a primary endpoint; primary nonresponders excluded.
  • Previous treatment with one TNF inhibitor biologic therapy was allowed, and 20% of patients had prior TNF inhibitor biologic exposure
  • Distinct patient populations comparison between indications is NOT intended

Important Safety Information

  • Cases of worsening congestive heart failure (CHF) and new onset CHF have been reported with TNF blockers.
  • Use of TNF blockers, including CIMZIA, has been associated with reactivation of hepatitis B virus in patients who are chronic carriers of the virus. In some instances, HBV reactivation occurring in conjunction with TNF blocker therapy has been fatal.
RAPID-PsA STUDY DESIGN

In an RA study, CIMZIA delivered consistent results regardless of prior TNF inhibitor exposure12

REALISTIC STUDY*

ACR20 response rates at week 1212

  • Primary efficacy measure was ACR20 response at week 12 for REALISTIC12
In the RAPID 1 Study, ACR20 response at week 24 (primary endpoint) was 59% in the CIMZIA 200 mg q2w + MTX qw group (n=393) compared with 14% for placebo q2w + MTX qw (n=199) (P<0.001). Some CIMZIA RA patients experienced a rapid ACR20 response within 1 to 2 weeks. References: (1) CIMZIA® [prescribing information], Smyrna, GA: UCB, Inc.; 2013. (2) Keystone E, van der Heijde D, Mason D Jr, et al. Certolizumab pegol plus methotrexate is significantly more effective than placebo plus methotrexate in active rheumatoid arthritis: findings of a fifty-two-week, phase III, multicenter, randomized, double-blind, placebo-controlled, parallel-group study. Arthritis Rheum. 2008;58:3319-3329. (5) Data on file. UCB, Inc.; Smyrna, GA.
  • ITT-NRI: intent-to-treat nonresponder imputation.
  • Patients were stratified at baseline by prior anti-tumor necrosis factor (TNF) experience (n=400 of 1063). Patients could have discontinued their prior TNF inhibitor for lack of efficacy, intolerance, or other reasons.
  • Distinct patient populations comparison between indications is NOT intended
  • See REALISTIC study design

No meaningful conclusions can be made in AS due to insufficient sample size of those exposed to prior TNF inhibitors

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