Pharmacy & Therapeutics - October 2008 - (Page 576)

Sustainable results PRECiSE 1 was the first 26-week, double-blind, long-term, true placebocontrolled trial in Crohn’s disease1 In PRECiSE 1, clinical remission at week 26 in the overall patient population for CIMZIA vs placebo was 29% vs 18%, respectively1 In PRECiSE 2, ~1 out of 2 patients* achieved remission at 6 months2,3 – In PRECiSE 3, ~8 out of 10 of those patients continuing therapy maintained remission through 18 months4 Patients in Clinical Remission2-5 HBI PRECiSE 2 † 4 n=215 Open-label extension HBI 4 n=141 Pivotal trial2‡ 668 patients ( 18 years of age 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 subcutaneously every 4 weeks (n=216) or placebo (n=212). Primary end point: response at week 26 in patients with baseline C-reactive protein 10 mg/L. Number of patients 48%* ~ 8 out of 10 120 80 40 0 26 28 32 36 40 44 48 n=103 n=78 1 year 52 56 60 64 68 72 76 80 Overall patient population 26 weeks Weeks Open-label extension trial4§ PRECiSE Maintenance Therapy Plasma concentration (µg/mL) 30 25 20 15 10 0 024 8 12 16 20 24 28 32 36 40 44 48 52 56 60 64 68 72 76 80 3,5 n=141 Patients completing the 26-week study could enter an ongoing open-label extension study (PRECiSE 3; n=141). Primary end point: assess the safety of continuous CIMZIA therapy. Secondary end points: obtain data on drug plasma concentrations and antibodies, plus additional effectiveness data. Weeks Charts represent patients in PRECiSE 2 who continued on CIMZIA therapy in PRECiSE 3 (n=141). Stable dosing PEGylation provides stable serum levels, enabling Q4-week dosing6 Predictable costs Stable dose, stable cost No dose escalation in clinical trials No weight-based dose adjustment necessary 2 200-mg subcutaneous injections—400-mg dose 3 Q4-week dosing recommended after an initial dose at weeks 0, 2, and 43 *Refers to responders to 6-week, open-label induction therapy. † Baseline Harvey-Bradshaw Index (HBI) score of 9. ‡ Randomized response and maintenance study. § Open-label, long-term extension trial for patients completing CIMZIA pivotal trial. Initial dose at weeks 0, 2, and 4 and then every 4 weeks as maintenance therapy. Serious and sometimes fatal side effects have been reported with CIMZIA, including tuberculosis and other serious infections. Please see Important Safety Information and Brief Summary of full Prescribing Information on adjacent pages.

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Pharmacy & Therapeutics - October 2008 Contents Editorial Medication Errors Prescription: Washington New Drugs/Drug News/ New Medical Devices Drug Forecast Medical Management of Parkinson’s Disease Why Is Health Care Regulation So Complex? The Next President’s Prescription for Action on Drugs Trends in Managing Multiple Sclerosis Product Profiler: Sancuso®

Pharmacy & Therapeutics - October 2008

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