A Delphi Panel to Address Management of Gastrointestinal Side Effects Observed with Use of Delayed-Release Dimethyl Fumarate

Background: Delayed-release dimethyl fumarate (DMF) is an oral therapy approved in the US and Australia for treatment of relapsing forms of multiple sclerosis (MS) and in Canada for treatment of relapsing-remitting MS (RRMS). In placebo-controlled clinical trials of DMF, events associated with gastrointestinal (GI) tolerability (e.g., nausea/vomiting, abdominal pain, diarrhea) were reported in 40% of patients treated with DMF (240 mg BID) compared with 31% of placebo-treated patients. An expert panel of investigators with substantial experience in the Phase 3 DMF clinical trial program previously provided insight into characterization and management of GI events associated with DMF, but real-world experience with respect to their severity, impact on daily activities, and management strategies is limited.

Objectives: To gain further insight into GI events associated with DMF from clinicians with experience managing patients treated with DMF and who experience GI events, to obtain consensus on the most effective strategies to manage side effects, and to obtain consensus on setting appropriate expectations for patients with GI events.

Methods: The Delphi method, a process of achieving consensus from an experienced panel, has been initiated in the US and Canada, and will use 2 or more rounds of questionnaires. A steering committee was convened to design and conduct surveys of health-care professionals who have MS patients receiving treatment with DMF. Each questionnaire includes questions relating to clinician experience with GI events associated with DMF treatment. Results from each questionnaire will be used to develop the subsequent questionnaire of the Delphi process. A summary of the results will be provided to respondents with the subsequent questionnaire, which is designed to narrow the range of responses as a means of trying to obtain consensus on the management of each specific GI event.

Results: The approach to obtaining consensus on managing DMF-associated GI events will be presented. These results of the Delphi process are intended to provide clinicians with strategies for managing DMF-associated GI events and to set appropriate expectations in patients based on real-world experience with DMF treatment.

Conclusions: Strategies and techniques to manage DMF-associated GI events based on real world experience are important in clinical practice to improve tolerability and compliance.

Study supported by: Biogen Idec, Inc.