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Report: Over Half of MS Patients Treated With Tecfidera Have Experienced Minor Side Effects

Lemtrada and ocrelizumab will likely be reserved for aggressive/severe MS

Decision Resources Group, a health care research firm located in Burlington, Mass., finds that more than half of audited patients with multiple sclerosis (MS) currently treated with the oral disease-modifying therapy (DMT) Tecfidera (dimethyl fumarate, Biogen Idec) have experienced flushing and/or gastrointestinal events during therapy.

However, few Tecfidera-treated patients are currently experiencing these side effects, signifying either the transient nature of such events or their effective medical management. Overall, fewer than 15% of surveyed neurologists felt that Tecfidera-related side effects were an obstacle to their prescribing of the product.

Most of the patients tested for anti-JC virus antibodies were treatment-naïve or were receiving a DMT other than Tysabri (natalizumab, Biogen Idec) at the time of testing, supporting neurologists’ reporting that the main driver of assay testing is related to patients’ potential candidacy for Tysabri. However, patients (regardless of serostatus) were more likely to stay on their original DMT than switch to another DMT for up to 2 years after testing.

When neurologists were asked to choose an emerging product for a hypothetical switch, the peginterferon beta-1a therapy Plegridy (Biogen Idec) — the product likely to reach the market first — was selected most often. More than half of surveyed neurologists believed that Plegridy is most likely to replace the interferon-beta-1a treatment Avonex (Biogen Idec). However, patient-level data suggest that the effect of Plegridy is more likely to be spread across the injectable DMTs, the report finds.

“Analysis of the emerging monoclonal antibodies Genzyme/Sanofi’s Lemtrada and Genentech/Roche’s ocrelizumab suggests that these DMTs would likely be prescribed to patients with more severe/aggressive MS and potentially compete with Tysabri, the DMT typically initiated when efficacy reasons are the main drivers of brand choice,” said analyst Emma McFadden, PhD. “Given Tysabri’s general position in the MS treatment algorithm as a third-line or later option, these emerging agents will be reserved primarily for patients who have failed earlier lines of therapy.”

McFadden continued: “Although it is still uncertain when, or even if, generic versions of Teva’s Copaxone 20 mg will be approved by the FDA, neurologists indicated that they plan to switch approximately one-fifth of audited patients to generic glatiramer acetate, once available. While it is not surprising that Copaxone 20 mg appears to be most at risk for generic switching, it is interesting to note that Tecfidera- and Tysabri-treated patients appear to be least likely to be switched, alluding to neurologists’ perception that these products have characteristics that justify the additional cost or reimbursement effort.”

Source: BioTrends Research Group; July 22, 2014.

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