Abstract
Objective: To evaluate the efficacy and safety of 2 infusions of eptinezumab for the preventive treatment of migraine in adults with chronic migraine (CM).
Background: Eptinezumab, an anti-CGRP monoclonal antibody, selectively inhibits the CGRP ligand, which plays an important role in migraine pathophysiology.
Design/Methods: Eligible patients (CM, ICHD-3β) were randomized to eptinezumab 100mg, 300mg, or placebo administered intravenously every 12 weeks (wks) for 2 infusions. The primary endpoint was the change from baseline in mean monthly migraine days (MMDs) over Wks1–12. Key secondary endpoints included: ≥75% migraine responder rates (RRs) over Wks1–4; ≥75% and ≥50% migraine RRs over Wks1–12.
Results: Baseline mean MMDs were ~16.1 across treatment groups (N=1072).
In 100mg-treated patients, changes from baseline in MMDs were −7.7 (p<0.0001) and −8.1 (p<0.0001) over Months1–3 and Months4–6, respectively. The ≥75% migraine RRs were: 30.9% (Month1; p<0.0001), 26.7% (Months1–3; p=0.0001), and 38.5% (Months4–6). The ≥50% migraine RRs were: 57.6% (Months1–3; p<0.0001) and 60.7% (Months4–6).
In 300mg-treated patients, changes from baseline in MMDs were −8.2 (p<0.0001) and −8.8 (p<0.0001) over Months1–3 and Months4–6, respectively. The ≥75% migraine RRs were: 36.9% (Month1; p<0.0001), 33.1% (Months1–3; p<0.0001), and 42.3% (Months4–6). The ≥50% migraine RRs were: 61.4% (Months1–3; p<0.0001) and 63.4% (Months4–6).
In placebo-treated patients, changes from baseline in MMDs were −5.6 and −6.1 over Months1–3 and Months4–6, respectively. The ≥75% migraine RRs were: 15.6% (Month1), 15.0% (Months1–3), and 22.7% (Months4–6). The ≥50% migraine RRs were: 39.3% (Months1–3) and 44.5% (Months4–6).
Rates of treatment-emergent adverse event were similar between groups.
Conclusions: Eptinezumab significantly reduced MMDs over 3 months, which was further improved through Month 6 following a second quarterly infusion. Migraine RRs were greater with eptinezumab vs placebo over 3 months and were sustained or increased through Month 6. The eptinezumab safety profile was consistent with previous trials.
Disclosure: Dr. Kudrow has received personal compensation for consulting, serving on a scientific advisory board, speaking, or other activities with Alder, Eli Lilly, Amgen, Promius and AOBiome. Dr. Kudrow has received research support from Amgen, Alder, Ely Lilly, Teva, Roche-Genentech, Allergan, Biohaven, UCB, and Viromed". Dr. Lipton has received personal compensation for consulting, serving on a scientific advisory board, speaking, or other activities with American Academy of Neurology, Alder Biopharmaceuticals, Allergan, American Headache Society, Amgen, Autonomic Technologies, Avanir Pharmaceuticals, Biohaven, Biovision, Boston Scientific, Dr. Reddy’s, Electrocore, Eli Lilly, eNeura Therapeutics, GlaxoSmithKline, Merck, Pernix, Pfizer, Supernus, Teva, Trigemina, Vector, and Vedanta. Dr. Lipton holds stock and/or stock options in Biohaven. Dr. Silberstein has received personal compensation for consulting, serving on a scientific advisory board, speaking, or other activities with Alder Biopharmaceuticals, Allergan, Amgen, Avanir, eNeura, ElectroCore Medical, Labrys Biologics, Medscape, Medtronic, Neuralieve, NINDS, Pfizer, and Teva. Dr. Silberstein has received compensation for serving on the Board of Directors of eNeura and Biohaven. Dr. Silberstein has received royalty, license fees, or contractual rights payments from Biohaven. Dr. Silberstein holds stock and/or stock options in Biohaven which sponsored research in which Dr. Silberstein was involved as an investigator. Dr. Silberstein holds stock and/or stock options in Biohaven. Dr. Silberstein has received research support from Allergan, Amgen, Cumberland Pharmaceuticals, ElectroCore Medical, Labrys Biologics, Eli Lilly, Merz, and Troy Healthcare.. Dr. Cady has received personal compensation for consulting, serving on a scientific advisory board, speaking, or other activities with Alder BioPharmaceuticals, Inc. Dr. Schaeffler has nothing to disclose. Dr. Biondi has received personal compensation for consulting, serving on a scientific advisory board, speaking, or other activities with Alder BioPharmaceuticals, Inc.. Dr. Biondi holds stock and/or stock options in Alder BioPharmaceuticals, Inc. Dr. Smith has received personal compensation for consulting, serving on a scientific advisory board, speaking, or other activities with Alder. Dr. Smith holds stock and/or stock options in Alder.
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