Study shows long-term efficacy of erenumab for chronic migraine
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A 52-week open label extension of a previous 12-week double-blind treatment study showed sustained efficacy and safety of erenumab for the treatment of chronic migraine.
Erenumab (Aimovig; Novartis, Amgen) is a human monoclonal antibody that selectively targets the calcinonin gene-related peptide (CGRP) receptor, according to Stewart J. Tepper, MD, professor of neurology at Geisel School of Medicine, Dartmouth-Hitchcock, and colleagues. Previous studies demonstrated the efficacy and safety of this new option for the treatment of episodic and chronic migraine. Both 70 mg and 140 mg doses, administered through a single monthly injection, are approved in the United States and European Union for the prevention of migraine in adults.
After completion of the 12-week double-blind placebo-controlled parent study, Tepper and colleagues conducted a multicenter, 52-week open label extension study to examine longer-term use of erenumab in patients with chronic migraine with or without aura, 350 of whom received erenumab 70 mg only; 60 received erenumab 140 mg only; and 199 initially received the 70 mg and were switched to the 140 mg dose at the 28-week visit.
The results demonstrated sustained efficacy of erenubab over the 52-week study period, with a nearly 50% reduction in mean monthly migraine days (MMD) and mean monthly migraine-specific medication use days (MSMD). A greater benefit was observed with the 140 mg dose regarding MMD, responder rates and reduction in MSMD. In the extension phase, the proportion of patients with a greater than 50% response increased significantly, suggesting an increased efficacy of the treatment over the long term. However, the withdrawal of some patients from the study might have impacted these results, the authors noted. Discontinuation, they clarified, was due to adverse events only in 16 patients.
Most adverse events associated with erenubab were grade 1 or grade 2 in severity and included constipation, itching, muscle spasm and injection site reaction, according to the researchers. In the open label extension study, the adverse events were similar to those observed during the double-blind treatment phase.
“This year-long, prospective study suggests that erenumab maintains effectiveness, is very well tolerated, and the trial is reassuring in that no new safety concerns emerged,” Tepper told Healio Primary Care. “The study also confirms that the 140 mg dose is almost always numerically higher in effectiveness outcome measures than the 70 mg dose.”
Erenumab is one of the currently available FDA-approved anti-CGRP therapies. Others include the three anti-CGRP ligand monoclonal antibodies Ajovy (fremanezumab-vfrm, Teva), Emgality (galcanezumab-gnlm, Lilly) and Vyepti (eptinezumab-jjmr, Lundbeck), and the gepants Ubrelvy (ubrogepant, Allergan) and Nurtec ODT (rimegepant, Biohaven).
“These novel therapeutic options represent a monumental change in the management of all types of migraine, including episodic and chronic migraine, migraine with and without aura, and migraine with acute medication overuse,” Tepper concluded. “The magnitude of responder rates with the monoclonal antibodies are unprecedented in the history of anti-migraine treatment. Every day in my clinic, patients are telling me of the life changing effects of these medications.” – by Michela Cimberle
Disclosures: Tepper reports receiving research grants from Alder, Allergan, Amgen, Dr. Reddy’s Laboratories, ElectroCore, Eli Lilly, eNeura, Neurolief, Novartis, Scion Neurostim, Teva and Zosano; consultant and/or advisory board fees from Acorda, Alder, Alexsa, Align Strategies, Allergan, Alphasights, Amgen, Aperture Venture Partners, Aralez Pharmaceuticals Canada, Axsome Therapeutics, Becker Pharmaceutical Consulting, BioDelivery Sciences International, Biohaven, Charleston Labs, Decision Resources, DeepBench, ElectroCore, Eli Lilly, eNeura, Equinox, ExpertConnect, GLG, GSK, Guidepoint Global, Healthcare Consultancy Group, Health Science Communications, Impel, Lundbeck, M3 Global Research, Magellan Rx Management, Marcia Berenson Connected Research and Consulting, Medicxi, Navigant Consulting, Neurolief, Nordic BioTech, Novartis, Pfizer, Pulmatrix, Reckner Healthcare, Relevale, Revance, Satsuma, Scion Neurostim, Slingshot Insights, Sorrento, Spherix Global Insights, Sudler and Hennessey, Synapse Medical Communications, Teva, Theranica, Thought Leader Select, Trinity Partners, XOC and Zosano; salary from Dartmouth-Hitchcock Medical Center and the American Headache Society; stock options from Nocira and Percept; and CME honoraria from the American Academy of Neurology, American Headache Society, Cleveland Clinic Foundation, Diamond Headache Clinic, Elsevier, Forefront Collaborative, Hamilton General Hospital in Ontario, Canada, Headache Cooperative of New England, Henry Ford Hospital, Detroit, Inova, Medical Learning Institute Peerview, Miller Medical Communications, North American Center for CME, Physicians’ Education Resource, Rockpointe and WebMD/Medscape. Please see the full study for all other authors’ relevant financial disclosures.
Perspective
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Katherine S. Carroll, MD
This 52-week open-label extension study reaffirms both the long-term safety profile and efficacy of erenumab, which mirrors what we are seeing in clinical practice. Primary care physicians should know that this treatment appears to be a safe and effective treatment option for patients who are struggling with achieving migraine control.
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