Summary

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• Tecfidera (dimethyl fumarate) is indicated for the treatment of relapsing forms of multiple sclerosis (MS), including clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease in adults.
• This summary is based on the review of 15 systematic review(s)/meta-analysis(es). ^[1-15]
• Dimethyl fumarate (DMF) was slightly more effective than teriflunomide in reducing short-term relapse risk (RR=0.92, p=0.01). Alemtuzumab, mitoxantrone, natalizumab, and fingolimod were more effective than DMF in reducing relapse risk within the first 24 months, with alemtuzumab showing the most significant reduction (RR versus placebo 0.46). Ocrelizumab and DMF both effectively reduced the number of new T2 lesions, with DMF having relative superiority in this outcome.
• DMF showed no significant impact on short-term confirmed disability worsening (CDW) compared with teriflunomide (RR=0.99, p=0.69). Natalizumab, alemtuzumab, and mitoxantrone were more effective than DMF in preventing short-term disability worsening. Ocrelizumab and DMF were effective in reducing the number of new Gd+T1/hypointense lesions on MRI.
• DMF 480 mg effectively reduced the number of new T2 lesions and was highly ranked for reducing new Gd+T1/hypointense lesions.
• Ozanimod demonstrated superior outcomes in confirmed disability progression at 3 months, annualized relapse rate, and the proportion of patients relapsed compared to DMF.
• General Adverse Events: DMF is associated with higher risks of gastrointestinal-related events (nausea, diarrhea, abdominal pain), flushing, pruritus, and significant lymphopenia, with a Number Needed to Treat for Harm (NNTH) of 29 for severe or life-threatening lymphopenia.
• Serious Adverse Events (SAEs): DMF did not show a significant increase in SAEs compared to placebo in pooled analyses, while Ozanimod demonstrated fewer overall AEs, SAEs, and discontinuations due to AEs compared to DMF.
• Pregnancy Outcomes: DMF was linked to the highest prevalence of premature births among disease-modifying therapies (DMTs), with significant occurrences of ectopic pregnancy and spontaneous abortion compared to the general population.
• The effectiveness of DMF in reducing relapse risk decreases in younger patients and treatment-naïve subjects. A higher incidence of premature births was observed in pregnant women treated with DMF, although overall safety in pregnancy aligns with the general population, barring specific outcomes like ectopic pregnancy and spontaneous abortion. Better outcomes in MS-related PML were noted in patients with lower JCV viral load and younger age at diagnosis.