CIMZIA® (certolizumab pegol) : Disease duration may impact clinical outcomes5,15

In a pivotal study (PRECiSE 2) of 668 patients with moderately to severely active CD, patients treated with CIMZIA had significantly higher rates of clinical response and remission compared to those treated with placebo1,14

  • The primary endpoint was a clinical Crohn’s Disease Activity Index (CDAI) response at week 26 (defined as a decrease from baseline in CDAI score of ≥100) in patients with a baseline C-reactive protein (CRP) level of at least 10 mg/L14
  • CIMZIA is indicated for reducing signs and symptoms of Crohn's disease and maintaining clinical response in adult patients with moderately to severely active disease who have had an inadequate response to conventional therapy

PRECiSE 2—Patients in clinical response* at week 26 (ITT-NRI)1,14

Overall Response

PRECiSE 2 Study: Patients in clinical response with CIMZIA 400 mg q4w (63%, n=215) vs placebo q4w (36%, n=210) at week 26 (P<0.001) (ITT-NRI). References: (1) CIMZIA® [prescribing information], Smyrna, GA: UCB, Inc.; 2013. (14) Schreiber S, Khaliq-Kareemi M, Lawrance IC, et al. Maintenance therapy with certolizumab pegol for Crohn’s disease. N Engl J Med. 2007;357:239-250.
  • CIMZIA 400 mg q4w
  • Placebo q4w
  • Overall clinical response (CR100) at week 26 was a prespecified secondary endpoint in PRECiSE 214
  • Response defined as a decrease from baseline in CDAI score of ≥100.
  • ITT-NRI: intent-to-treat nonresponder imputation
  • All patients received a loading dose of CIMZIA 400 mg at weeks 0, 2, and 4
  • 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.

PRECiSE 2—Patients in clinical remission* at week 26 (ITT-NRI)1,14

Overall Remission

PRECiSE 2 Study: Patients in clinical remission with CIMZIA 400 mg q4w (48%, n=215) vs placebo q4w (29%, n=210) at week 26 (P<0.001) (ITT-NRI). References: (1) CIMZIA® [prescribing information], Smyrna, GA: UCB, Inc.; 2013. (14) van der Heijde D, Keystone EC, Curtis JR, et al. Timing and magnitude of initial change in disease activity score 28 predicts the likelihood of achieving low disease activity at 1 year in rheumatoid arthritis patients treated with certolizumab pegol: a post-hoc analysis of the RAPID-1 trial. J Rheumatol. 2012;39:1326-1333.
  • CIMZIA 400 mg q4w
  • Placebo q4w
  • Overall clinical remission at week 26 was a prespecified secondary endpoint in PRECiSE 214
  • Remission defined as CDAI score of ≤150.
  • ITT-NRI: intent-to-treat nonresponder imputation
  • All patients received a loading dose of CIMZIA 400 mg at weeks 0, 2, and 4

PRECiSE 2—CR100 response in patients with CRP ≥10 mg/L at baseline by disease duration (ITT)5,15*

  • Clinical response impacted by disease duration in patients with active disease
  • Treatment response rates in patients who had active disease for less than 8 years and those who have had active disease of greater duration

Disease duration response

PRECiSE 2 Study: CR100 response rates for patients with disease duration <8 years (CIMZIA: 70%, n=70; Placebo: 36%, n=73; P<0.001) and ≥8 years (CIMZIA: 48%, n=42; Placebo: 29%, n=28, CIMZIA 400 mg at weeks 0, 2, and 4, then placebo every 4 weeks; Nominal P value). CR100 response rates for CIMZIA patients in the overall population at week 26 were 69% and 54% for those with disease duration <8 years and ≥8 years, respectively. References: (5) Data on file. UCB, Inc.; Smyrna, GA. (15) Schreiber S, Colombel JF, Bloomfield R, et al. Increased response and remission rates in short-duration Crohn’s disease with subcutaneous certolizumab pegol: an analysis of PRECiSE 2 randomized maintenance trial data. Am J Gastroenterol. 2010;105(7):1574-1582.
  • CIMZIA
  • Placebo (CIMZIA 400 mg at weeks 0, 2, and 4, then placebo every 4 weeks)
  • CR100 response rates for CIMZIA patients in the overall population at week 26 were 69% and 54% for those with disease duration <8 years and ≥8 years, respectively5
  • Mean disease duration at baseline was 8 years5
  • Prespecified analysis of the primary endpoint.
  • 400 mg at weeks 0, 2, and 4, then CIMZIA 400 mg every 4 weeks.
  • Rare reports of blood dyscrasias have been reported with CIMZIA; patients should be advised to seek medical attention if they develop.
  • Patients on CIMZIA should not receive live or live-attenuated vaccines.