CIMZIA® (certolizumab pegol) patients achieved significant clinical response and remission1,14

The PRECiSE 2 pivotal trial was a 26-week trial involving randomization to maintenance therapy with CIMZIA 400 mg every 4 weeks or withdrawal to placebo among 668 patients with moderate to severe CD who had a clinical response at week 6 to open-label induction therapy with CIMZIA 400 mg at weeks 0, 2, and 4. At week 26, a statistically significantly greater proportion of week 6 responders were in clinical response (decrease in CDAI ≥100 from baseline; primary endpoint) and in clinical remission (CDAI ≤150) in the CIMZIA-treated group compared to the group who received placebo.1,14

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

Response

Defined as a decrease from baseline in CDAI score ≥10014

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. 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 (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; CDAI: Crohn's Disease Activity Index
  • All patients received a loading dose of CIMZIA 400 mg at weeks 0, 2, and 4
  • Serious and sometimes fatal side effects have been reported with CIMZIA, including tuberculosis (TB), bacterial sepsis, invasive fungal infections (such as histoplasmosis), and infections due to other opportunistic pathogens (such as Legionella or Listeria). Patients should be closely monitored for the signs and symptoms of infection during and after treatment with CIMZIA. Lymphoma and other malignancies, some fatal, have been reported in children and adolescent patients treated with TNF blockers, of which CIMZIA is a member. CIMZIA is not indicated for use in pediatric patients.

Remission

Defined as CDAI score ≤15014

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) 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: 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) 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 (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; CDAI: Crohn's Disease Activity Index
  • All patients received a loading dose of CIMZIA 400 mg at weeks 0, 2, and 4
  • Serious and sometimes fatal side effects have been reported with CIMZIA, including tuberculosis (TB), bacterial sepsis, invasive fungal infections (such as histoplasmosis), and infections due to other opportunistic pathogens (such as Legionella or Listeria). Patients should be closely monitored for the signs and symptoms of infection during and after treatment with CIMZIA. Lymphoma and other malignancies, some fatal, have been reported in children and adolescent patients treated with TNF blockers, of which CIMZIA is a member. CIMZIA is not indicated for use in pediatric patients.