CIMZIA® (certolizumab pegol) : Clinical response with or without prior biologic treatment

  • The primary endpoint in PRECiSE 2 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 and clinical remission at week 26 (overall; ITT-NRI)1,14

Overall Response

PRECiSE 2 Study: Overall 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. PRECiSE 2 Study: Overall 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
  • Cases of worsening congestive heart failure (CHF) and new onset CHF have been reported with TNF blockers
  • Overall clinical response (decrease in CDAI ≥100 from baseline) and remission (CDAI ≤150) at week 26 were prespecified secondary endpoints in PRECiSE 214
  • 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—Clinical response at week 26 in bio-naive patients (ITT-NRI)1,14

Response in bio-naive patients14

PRECiSE 2 Study: Response in bio naive patients with CIMZIA 400 mg q4w (69%, n=163) vs placebo q4w (40%, n=159) 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. PRECiSE 2 Study: Response in bio naive patients with CIMZIA 400 mg q4w (69%, n=163) vs placebo q4w (40%, n=159) 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
  • Cases of worsening congestive heart failure (CHF) and new onset CHF have been reported with TNF blockers
  • 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—Clinical response at week 26 in patients previously treated with a biologic (ITT-NRI)1,14

Response in bio-experienced patients14

PRECiSE 2 Study: Response in prior anti-TNF patients with CIMZIA 400 mg q4w (44%, n=52) vs placebo q4w (25%, n=51) at week 26 (P=0.02) (ITT-NRI).* Reference: (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. PRECiSE 2 Study: Response in prior anti-TNF patients with CIMZIA 400 mg q4w (44%, n=52) vs placebo q4w (25%, n=51) at week 26 (P=0.02) (ITT-NRI).* Reference: (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
  • Cases of worsening congestive heart failure (CHF) and new onset CHF have been reported with TNF blockers
  • ITT-NRI: intent-to-treat nonresponder imputation
  • All patients received a loading dose of CIMZIA 400 mg at weeks 0, 2, and 4
  • Cases of lymphoma and other malignancies have been observed among patients receiving TNF blockers, including children, adolescents, and young adults. Acute and chronic cases of leukemia have also been reported. Postmarketing cases of hepatosplenic T-cell lymphoma (HSTCL), a rare type of T-cell lymphoma that has a very aggressive disease course and is usually fatal, have been reported in patients treated with TNF blockers, including CIMZIA. Melanoma and Merkel cell carcinoma have been reported in patients treated with TNF-antagonists, including CIMZIA. Periodic skin examinations are recommended for all patients, particularly those with risk factors for skin cancer.