Pharmacy & Therapeutics- July 2008 - (Page 382) Sustainable results PRECiSE Patients in Clinical Remission1- 4 PRECiSE 2 HBI 4*† n=215 Open-label extension HBI 4 n=141 48%‡ Number of patients ~ 8 out of 10 120 n=103 n=78 1 year 80 40 0 Overall patient population 26 weeks 26 28 32 36 40 44 48 52 56 60 64 68 72 76 80 Weeks Chart represents patients in PRECiSE 2 who continued on CIMZIA therapy in PRECiSE 3 (n=141). *Baseline Harvey-Bradshaw Index (HBI) score of 9. † HBI5,6 – Accepted evaluation method in Crohn’s disease – Index that includes measures of general well-being and abdominal pain and mass – Easier to use in clinical practice than CDAI ‡ Refers to responders to 6-week, open-label induction therapy. ~1 out of 2 patients‡ achieved remission at 6 months1,2 – ~8 out of 10 of those patients continuing therapy maintained remission through 18 months3 PRECiSE 1—Overall Remission7§ CIMZIA P .05 Placebo 40 Patients (%) 29% 20 18% 0 Overall patient population Week 26 § Clinical response defined as 100-point reduction in CDAI score and clinical remission as CDAI score 150 points. Unique—first 26-week, double-blind, long-term, true placebo-controlled trial in Crohn’s disease7 Strict parameters—both coprimary end points had to be satisfied for clinical success 7 – Response at both weeks 6 and 26 required to reach primary end point 7§ Real world—included patients with or without baseline 5-ASAs, immunosuppressants, corticosteroids, or prior infliximab use 7
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