Results of a Delphi Panel to Address Management of Gastrointestinal Side Effects Observed with Use of Delayed-release Dimethyl Fumarate (P3.242)

OBJECTIVE: To gain insight into gastrointestinal (GI) events associated with delayed-release dimethyl fumarate (DMF) from clinicians who treat patients with relapsing-remitting multiple sclerosis (RRMS), and to obtain consensus on effective management strategies and appropriate expectations for patients with GI events. BACKGROUND: Delayed-release DMF (240 mg twice daily) is approved for treatment of relapsing forms of MS (USA, Australia) or relapsing-remitting MS (Canada, EU). In clinical trials, events associated with GI tolerability (nausea, vomiting, abdominal pain, diarrhea) were more common in patients treated with delayed-release DMF compared with placebo-treated patients. The Delphi method (a consensus-building technique) was initiated in the US and Canada to obtain information about managing these side effects in a real-world setting. DESIGN/METHODS: A steering committee designed and conducted surveys of clinicians in the US and Canada whose MS patients receive treatment with delayed-release DMF. Two rounds of questionnaires were developed that include questions relating to clinician experience with treatment-associated GI events. Results from the first questionnaire were used to develop the second questionnaire and were provided along with the second questionnaire in an effort to obtain consensus on the management of each specific GI event. RESULTS: Sixty-four respondents completed the first round questionnaire. Most (63/64) indicated that 蠅1 of their patients had experienced GI side effects (typically <20[percnt] of patients). Most strategies attempted to manage the GI side effects, including food-based strategies, prescription medications, and/or nonprescription medications were reported as effective some of the time. The most frequently used strategies were included in the second round questionnaire to obtain consensus (蠅70[percnt] agreement) regarding their potential effectiveness. The final results of the Delphi process will be presented. CONCLUSIONS: Strategies identified by clinicians to manage GI events associated with delayed-release DMF will be important in clinical practice to improve tolerability and compliance. Study Supported by: Biogen Idec Inc. Disclosure: Dr. Phillips has received personal compensation for activities with Acorda Therapeutics, Biogen Idec, Genzyme, Merck Serono, and Sanofi-Aventis Pharmaceuticals, Inc. as a consultant. Dr. Erwin has received personal compensation for activities with Novartis and Biogen Idec. Dr. Agrella has received personal compensation for activities with Acorda Therapeutics, Biogen Idec, Teva Neuroscience, Genzyme Corporation, Serono, Inc. and Pfizer. Dr. Kremenchutzky has received personal compensation for activities with Biogen Idec, Sanofi, Genzyme, Novartis, Bayer Pharmaceuticals Corp., Teva Neuroscience, and EMD Serono as a consultant. Dr. Kremenchutzky has received research support from Biogen Id Dr. Kramer has received personal compensation for activities with Biogen Idec. Dr. Kendter has received personal compensation for activities with Biogen Idec. Dr. Abourjaily holds stock and/or stock options in Biogen Idec, which sponsored research in which Dr. Abourjaily was involved as an investigator. Dr. Rana has received personal compensation for activities with Biogen Idec as an employee. Dr. Fox has received personal compensation for activities with Biogen Idec, GlaxoSmithKline, Inc., Novartis, Questcor, Teva, and Xenoport. Dr. Fox has received research support from Novartis.