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

REALISTIC STUDY*
ACR20 response rates at week 1212

  • Primary efficacy measure was ACR20 response at week 12 for REALISTIC12
In the REALISTIC Study, ACR20 response at week 12 for patients overall (primary endpoint) was 51% in the CIMZIA 200 mg q2w (+/-DMARD[s]) group (n=851) compared with 26% for placebo q2w (+/-DMARD[s]) (n=212) (P<0.001). ACR20 response at week 12 for patients with prior TNF inhibitor experience was 47% in the CIMZIA 200 mg group (n=320) compared with 28% for placebo (n=80) (P<0.01). Reference: (12) Weinblatt ME, Fleischmann R, Huizinga TW, et al. Efficacy and safety of certolizumab pegol in a broad population of patients with active rheumatoid arthritis: results from the REALISTIC phase IIIb study. Rheumatology. 2012;51:2204-2214.
  • ITT-NRI: intent-to-treat nonresponder imputation.
  • Patients were stratified at baseline by prior TNF inhibitor 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

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.
  • Treatment with TNF blockers, including CIMZIA, may rarely result in new onset or exacerbation of clinical symptoms and/or radiographic evidence of central or peripheral nervous system demyelinating disease, as well as the development of a lupus-like syndrome.
SEE REALISTIC
STUDY DESIGN

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

  • Primary efficacy measure was ACR20 response at week 121,10
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.
  • Distinct patient populations comparison between indications is NOT intended
  • See RAPID-PsA study design