Consistent efficacy for bio-naïve patients

PRECiSE 1 Trial

The PRECiSE 1 trial was a randomized, double-blind, placebo-controlled trial that included 662 adult patients with a ≥3-month history of active Crohn's disease (a Crohn's Disease Activity Index [CDAI] score of 220-450). The majority of PRECiSE 1 study participants (n=474) had not previously been treated with an anti-TNF therapy.1

Primary end points
  • A decrease of at least 100 points in the CDAI score at week 6 and at both weeks 6 and 26 in patients with a baseline serum CRP level of ≥10 mg per liter1
Secondary end points
  • Remission at week 6 and at both weeks 6 and 26 in patients with a baseline serum CRP level of ≥10 mg per liter1
  • A decrease of at least 100 points in the CDAI score and remission at week 6 and at both weeks 6 and 26 among all patients, regardless of CRP concentration1
Results
  • At week 6, more patients in the CIMZIA group had a response compared with placebo (35% vs 27%)1
  • At weeks 6 and 26, more patients in the CIMZIA group had a response compared with placebo (23% vs 16%)1
  • Clinical response was seen regardless of concomitant corticosteroid or immunosuppressant therapy or prior infliximab use1*
  • 40% of bio-naïve patients showed a response at week 61

*Clinical response was defined as a decrease in Crohn's Disease Activity Index score of ≥100 points.

PRECiSE 2 Trial

PRECiSE 2 was a randomized, double-blind, placebo-controlled trial in which 668 adults patients with a ≥3-month history of active Crohn's disease (a CDAI score of 220-450) received 400 mg at weeks 0, 2, and 4 in open-label induction phase.2 Patients who responded at week 6 were randomized to receive CIMZIA subcutaneously every 4 weeks (n=216) or placebo (n=212). Primary end point was response at week 26. The majority of patients in the intention-to-treat population had not previously been treated with an anti-TNF therapy (n=322).2

Primary end point
  • Response at week 26 in patients with baseline C-reactive protein (CRP) ≥10 mg/L2
Secondary end points
  • Response at week 262
  • Remission at week 26 in the intention-to-treat population2
  • Remission in patients with a baseline CRP ≥10 mg/L2
Results
  • At week 6, following 3 initial 400-mg doses of CIMZIA, 64% of patients had a response. Thirty-six percent of patients did not have a response and did not remain in the study2
  • At week 26, response was maintained in 62% of patients with a baseline CRP level of ≥10 mg/L vs 34% of patients in the placebo arm with similar CRP measures2
  • Clinical response was seen regardless of concomitant corticosteroid or immunosuppressant therapy or prior infliximab use2*


Click to enlarge

  • A post hoc analysis of the PRECiSE 2 study demonstrated the sustained efficacy of CIMZIA in maintaining response and remission over 26 weeks in both patients previously treated with the biologic drug infliximab and in patients never treated with infliximab. A tendency toward a larger level of response and remission was seen in the infliximab-naïve patients2,3

PRECiSE 3

PRECiSE 3 is an ongoing open-label extension study, enrolling patients who completed 26 weeks in the PRECiSE 2 study (n=141).5*

  • Continuous CIMZIA 400-mg therapy provided long-term remission over 4 years in patients who initially responded to CIMZIA induction therapy.6
  • Infliximab-naïve patients in particular showed long-term remission rates in PRECiSE 36

* Patients who completed either the PRECiSE 1 or PRECiSE 2 maintenance trials were eligible to enroll in PRECiSE 3. Results shown
   here are from the subpopulation of PRECiSE 2, where patients who responded to induction were randomized to either a placebo
   or active arm in the maintenance phase.

Indication
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.

Important Safety Information
Patients treated with CIMZIA are at an increased risk for developing serious infections involving various organ systems and sites that may lead to hospitalization or death. Patients greater than 65 years of age, patients with co-morbid conditions, and/or patients taking concomitant immunosuppressants (e.g. corticosteroids or methotrexate) may be at a greater risk of infection.

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.

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