Dimethyl-Fumarate May Maintain NEDA After Natalizumab Discontinuation
Over 90% of participants achieved NEDA-3 after being transitioned to dimethyl-fumarate from natalizumab.
Demethyl-fumarate may serve to be a good treatment option for patients who discontinue natalizumab, new data indicate. The findings were presented at the 32nd European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS) Congress, September 14-17, 2016 in London.
Previous research has indicated that fingolimod fails to stop multiple sclerosis (MS) disease reactivation after natalizumab discontinuation, a common practice in patients who are anti-JCV seropositive and face a heightened risk of progressive multifocal leukoencephalopathy (PML).
In this study, senior author Massimiliano Calabrese, MD, PhD, of the University of Verona in Italy, and colleagues examined the efficacy of dimethyl-fumarate for the prevention of MS reactivation in patients who discontinued natalizumab.
The study included 37 patients with relapsing-remitting MS with a high concentration of JCV antibodies and a history of more than 2 years of treatment with natalizumab. After an approximate 1 month washout period, patients were transitioned from natalizumab to dimethyl-fumarate using an increasing dose scheme of 120 mg twice daily for 1 week, then 240 mg twice daily. Patients' Expanded Disability Status Scale (EDSS) scores were evaluated monthly for a mean of 9.8 months, and 3T MRI was performed at baseline and every 3 months following initiation of therapy. Patients were evaluated for disability progression, relapses, and MRI activity, with no evidence of disease activity (NEDA-3) defined as no clinical relapses, no disability progression, and no MRI activity.
Three patients were excluded from the final analysis due to a lack of data. Among the 34 patients who completed the 9-month follow-up, 31 achieved NEDA-3. One patient experienced a relapse and showed MRI activity, and 2 patients showed MRI activity alone. Notably, disease activity only occurred within the first 3 months of dimethyl-fumarate treatment in all patients, and no new side effects were noted.
While treatment with demthyl-fumarate does not completely rule out disease reactivation in some patients, the results indicate it can be a promising option for patients looking for transition off of natalizumab. Larger studies are needed to confirm these results, the authors concluded.
Disclosures: Massimiliano Calabrese, MD, PhD, reports being an advisory board member for Bayer-Schering, Genzyme, and Bioden Idec. He also reports payment for speaking engagements for Biogen-Elan, Genzyme, TEVA, and Bayer-Schering, and travel reimbursement from Novartis Pharma, Genzyme, Biogen Idec, Merck Serono, Bayer-Schering, and TEVA.
Farina G, Pitteri M, Magliozzi R, et al. Can dimethyl-fumarate be a good treatment choice after natalizumab discontinuation? Presented at: ECTRIMS 2016. September 14-17, 2016; London, UK. Poster 1154.