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• W2783507691 abstract "Objective: To assess annualized relapse rate (ARR) and lymphopenia during the OLMP of the ORACLE-MS study. Background: In the ORACLE-MS study in patients with a first demyelinating event, cladribine tablets (3.5 and 5.25 mg/kg) significantly reduced risk of conversion to clinically definite MS (CDMS) vs placebo. If CDMS occurred in the initial double-blind treatment period (DBTP), patients entered an open-label maintenance period (OLMP) and received interferon-beta 1a. Design/Methods: Participation in the OLMP was dependent upon the clinical course of the patient’s disease in the DBTP. Patients in ORACLE-MS who converted to CDMS (Poser criteria) during the DBTP entered the OLMP and received subcutaneous interferon-beta 1a (titrated over 4 weeks to 44 mcg) 3 times/week. Results: 109 ORACLE-MS patients converted to CDMS in the DBTP and received ≥1 dose of interferon-beta 1a. Median time on interferon-beta 1a was 56.0 weeks. Estimated ARR in the OLMP was 0.14 (95% confidence interval [CI] 0.00–0.27) for patients (n=25) originally treated with cladribine tablets 3.5 mg/kg; 0.24 (95% CI 0.07–0.40) for patients (n=24) treated with 5.25 mg/kg, and 0.42 (95% CI 0.28–0.56) for patients (n=60) who received placebo in the DBTP. Conclusions: A durable treatment effect of cladribine tablets given in the DBTP was observed in patients who converted to CDMS and switched to treatment with a different disease modifying drug (interferon beta-1a). Patients treated with cladribine tablets during the DBTP who converted to CDMS had a lower ARR during the OLMP than those given placebo during the DBTP. The incidence of lymphopenia was low in patients switched from cladribine tablets after conversion to CDMS and treated with interferon-beta, even if given within 10 months of the last cladribine tablet dose. The durable efficacy of cladribine tablets in the ORACLE-MS OLMP is consistent with the results of other clinical studies of cladribine tablets. Disclosure: Prof. Comi has received personal compensation for activities with Novartis, Teva Pharmaceutical Ind. Ltd, Sanofi, Genzyme, Merck Serono, Bayer, Actelion Sano as a speaker, consultant or participating on an advisory board. Dr. Leist has received personal compensation for activities with EMD Serono, Teva Neuroscience, Biogen, Bayer, Pfizer as a consultant. Dr. Leist has received research support from EMD Serono, Teva Neuroscience, Bayer, ONO, Novartis, Daiichi, and Acorda. Dr. Freedman has received personal compensation for activities with Bayer HealthCare, Biogen Idec, EMD Canada, Novartis, Sanofi, Teva Canada Innovation, Chugai, Merck Serono, Novartis, Opexa for honoraria, consulting or participating on a advisory board. Dr. Cree has received personal compensation for activities with AbbVie, Biogen, EMD Serono, Novartis and Shire as a consultant. Dr. Coyle has received personal compensation for activities with AbbVie, Accordant, Acorda, Bayer, Biogen Idec, Genentech/Roche, Genzyme/Sanofi, Mallinckrodt, Novartis, Serono, and Teva as a consultant. Dr. Hartung has received personal compensation from Bayer, Biogen, CSL Behring, Grifols, Merck Serono, Novartis, Roche, and Sanofi Genzyme as a speaker and consultant. Dr. Vermersch has received personal compensation for activities with Biogen, Roche, Merck, Teva, Sanofi Genzyme, and Almirall. Dr. Vermersch has received research support from Roche, Biogen and Sanofi Genzyme. Dr. Damian has received personal compensation for activities with EMD Serono, Inc as an employee. Dr. Dangond has received personal compensation for activities with EMD Serono, Inc. as an employee." @default.
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• W2783507691 date "2017-04-18" @default.
• W2783507691 modified "2023-09-27" @default.
• W2783507691 title "Cladribine tablets in the ORACLE-MS study open-label maintenance period: analysis of efficacy in patients after conversion to clinically definite multiple sclerosis (CDMS) (P6.349)" @default.
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