Clinical Experience with Tecfidera

Background: Tecfidera® (Dimethyl fumarate) was FDA approved for use in persons with MS in April 2013, making it the newest oral disease modifying agent (DMA) for MS. There are over 100,000 patient years of experience with a compound of dimethyl fumarate and its esters (Fumaderm®) used in Europe to treat psoriasis.

Objectives: To describe management of persons with MS on Tecfidera® in a post-marketing outpatient clinic setting.

Methods: Patients were placed on Tecfidera® if they were failing therapy with conventional DMA.  Failure was defined as increase in clinical relapses, increase in radiologic disease activity, or intolerability to DMA side effects. Two people with new diagnoses of MS were started on Tecfidera® because of their refusal to take injectable agents.  Patients had a comprehensive metabolic panel, complete blood count with differential, platelets and urine analysis at baseline, and then every two months for the first six months, and then every three to four months thereafter.

Results: Thirty patients began therapy with Tecfidera® between April 2013 and January 2014.  Five patients discontinued therapy (16.67% drop out rate). The primary reason for drop out for all five patients was intolerable GI side effects; additionally one of these patients developed splenomegaly which occured just over a week after starting Tecfidera® and resolved after the drug was stopped. We instituted a slower titration than recommended by the manufacturer, which appeared to lessen symptoms for some patients. Other strategies which seemed to ameliorate side effects included taking the medication with fat-containing food, use of yogurt and probiotics, anticholinergic medications for GI symptoms, simethicone for gas pain, antiemetics for nausea and baby aspirin for flushing. Twenty-five patients completed at least one set or more of labs post-initiation. Of interest, lab data is available for four out of the five patients who discontinued the medication due to gastrointestinal side effects and revealed eosinophilia in all four patients. None of the other twenty-one patients showed eosinophilia.

Conclusions: Our results in a real world setting are similar to the clinical trials in terms of adverse events, tolerability and drop out rate. In our small sample size, eosinophilia appeared only in the patients with gastrointestinal side effects severe enough to necessitate discontinuation of Tecfidera.