Efficacy and safety of erenumab (AMG334) in episodic migraine patients with prior preventive treatment failure: A subgroup analysis of a randomized, double-blind, placebo-controlled study.

Authors:
Peter J Goadsby
Peter J Goadsby
University of California
United States
Koen Paemeleire
Koen Paemeleire
Ghent University Hospital
Belgium
Gregor Broessner
Gregor Broessner
Innsbruck Medical University
Austria
Jan Brandes
Jan Brandes
Vanderbilt University School of Medicine
United States
Jan Klatt
Jan Klatt
University Medical Center Hamburg-Eppendorf
Germany
Feng Zhang
Feng Zhang
College of Pharmacy
China
Hernan Picard
Hernan Picard
Service Hospitalo-Universitaire
France
Robert Lenz
Robert Lenz
University of Massachusetts
United States

Cephalalgia 2019 Jun 13;39(7):817-826. Epub 2019 Apr 13.

7 Amgen Inc., Thousand Oaks, CA, USA.

Background: Erenumab was effective and well tolerated in a pivotal clinical trial of episodic migraine that included subjects both naïve to, and those who had failed, previous preventives. Here we evaluated the efficacy and safety of erenumab (70 mg or 140 mg) versus placebo in the subgroup of patients who had previously failed preventive treatment(s): ≥1 or ≥2 prior failed migraine preventive categories, and in patients who had never failed.

Methods: Prespecified subgroup analyses evaluated change from baseline to months 4-6 (the primary endpoint of the blinded study phase) in monthly migraine days, achievement of ≥50% and ≥75% reduction in monthly migraine days, and change from baseline in acute migraine-specific medication days. Adverse events were also evaluated.

Results: Treatment with both doses of erenumab resulted in greater reductions in monthly migraine days at months 4-6 (treatment difference versus placebo [95% CI], never failed subgroup: -0.9 [-1.5, -0.3] for 70 mg and -1.3 [-1.9, -0.7] for 140 mg; ≥1 prior failed medication categories subgroup: -2.0 [-2.8, -1.2] for 70 mg and -2.5 [-3.4, -1.7] for 140 mg; ≥2 prior failed medication categories subgroup: -1.3 [-2.6, 0.0] for 70 mg and -2.7 [-4.0, -1.4] for 140 mg). Similar results were observed in the monthly acute migraine-specific medication days endpoint, and in the achievement of ≥50% and ≥75% reduction in monthly migraine days. For the ≥50% reduction in monthly migraine day endpoint, placebo response in the no prior treatment failed group was 32.6%, in the ≥1 failed treatment 17.5%, and in the ≥2 failed treatments 11.1%.

Conclusion: Erenumab showed consistent efficacy in episodic migraine patients who had failed prior preventive treatments and was well tolerated across subgroups. The data suggest prior patients with prior treatment failures have lower placebo response rates.

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Source
http://dx.doi.org/10.1177/0333102419835459DOI Listing
June 2019
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