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.
After initial dosing1
~2/3 of patients achieved CR100 response at week 6 of therapy1
Pivotal trial 668 patients (adults with Crohn's disease ≥3 months) received CIMZIA 400 mg at weeks 0, 2, and 4 in open-label induction phase. Responders at week 6 received CIMZIA every 4 weeks (n=216) or placebo (n=212). Primary end point: response at week 26 in patients with baseline C-reactive protein (CRP) ≥10 mg/L. Clinical response was defined as a ≥100-point reduction in CDAI score and clinical remission as a CDAI score ≤150 points.
Open-label extension trial Patients completing the 26-week study could enter an ongoing open-label extension study (PRECiSE 3, n=141). Primary end point: to assess the effectiveness and safety of continuous CIMZIA therapy.
Results 64% of patients showed response to open-label induction therapy. Among responders randomized to active treatment, response was maintained at week 26 in 62% of patients with a baseline CRP level of 10 mg/L vs 34% of patients in the placebo arm with similar CRP measures.
In this posthoc analysis of a large, randomized, placebo-controlled trial of patients with moderate-to-severe Crohn's disease (PRESCISE 2), the primary end points were a decrease in Crohn's Disease Activity Index (CDA) score of ≥100 points (CR100). Remission was defined as a CDA1 score of ≤150 points. A response rate of CR70 was also studided as part of the posthoc analysis.
1 predictable subcutaneous Q4-week dose4
CIMZIA provided stable serum levels in clinical trials, yielding 1 predictable subcutaneous Q4-week dose4*
Pivotal trial 668 patients (adults with Crohn's disease ≥3 months) received CIMZIA 400 mg at weeks 0, 2, and 4 in open-label induction phase. Responders at week 6 received CIMZIA every 4 weeks (n=216) or placebo (n=212). Primary end point: response at week 26 in patients with baseline C-reactive protein (CRP) ≥10 mg/L. Clinical response was defined as a ≥100-point reduction in CDAI score and clinical remission as a CDAI score ≥150 points.
PRECiSE 32,5,7 Ongoing, open-label extension study of PRECiSE 1 and 2 to evaluate the long-term safety and effectiveness of CIMZIA in Crohn's disease over a period of years. All patients who successfully completed 6 months of CIMZIA therapy in PRECiSE 2 were eligible to participate in PRECiSE 3. Patients received CIMZIA 400 mg every 4 weeks starting at week 2 of the extension trial (n=141). Efficacy was assessed using the Harvey-Bradshaw Index (HBI), with remission defined as an HBI score ≤4. Nonresponders were defined as patients who withdrew or were given rescue medication. At 4 years' follow-up, 79% of observed patients were in remission.
ITT results Overall remission rates per historical ITT analysis: 63% at 12 months, 50% at 24 months, 25% at 48 months.
*Initial dose at weeks 0, 2, and 4, then every 4 weeks as maintenance therapy.
Chart represents patients in PRECiSE 2 who continued on CIMZIA therapy in PRECiSE 3.
*Represents week 6 responder analysis from PRECiSE 2 open-label extension study. Observed remitter analysis at 48 months, n=34/43. Months on therapy includes PRECiSE 2 and PRECiSE 3.
†Refers to responders to 6-week, open-label indiction therapy. ‡29% of patients taking placebo achieved clinical remission.
long-term remission2,3
At 4 years, 79% of observed patients continuing on CIMZIA were in remission with no dose escalation2,3*
Chart represents patients who completed assessments and achieved clinical remission, CDA1 ≤150 or Harvey-Bradshaw Index (HB1) ≤4. 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 entering PRECiSE 3, where patients who responded to induction were randomized to either a placebo or active arm in the maintenance phase.
