Objective To evaluate the effect of erenumab on patient-reported, functional outcomes in patients with episodic migraine (EM) in whom 2–4 preventives were not useful from the Phase 3b LIBERTY study.
Methods As previously reported, 246 patients with EM with 2–4 prior failed preventives were randomised 1:1 to subcutaneous erenumab 140 mg or placebo every 4 weeks for 12 weeks. This analysis evaluated Migraine Physical Function Impact Diary (MPFID), Headache Impact Test (HIT-6) and Work Productivity and Activity Impairment (WPAI) scores at Week 12. P values were nominal without multiplicity adjustment.
Results Erenumab significantly improved MPFID-Physical Impairment (PI) and Everyday Activities (EA) scores versus placebo (treatment difference (TD) (95% CI) MPFID-PI: −3.5 (−5.7 to –1.2) (p=0.003); MPFID-EA: −3.9 (−6.1 to –1.7)) (p<0.001) at 12 weeks. Patients on erenumab were more likely to have a ≥5-point reduction in MPFID score (OR vs placebo (95% CI) MPFID-EA: 2.1 (1.2 to 3.6); MPFID-PI: 2.5 (1.4 to 4.5)). A similar trend was observed for HIT-6 (TD: −3.0; p<0.001); significantly higher proportions of patients on erenumab reported a ≥5-point reduction (OR (95% CI): 2.4 (1.4 to 4.1)). In three out of four WPAI domains, erenumab showed improvement versus placebo.
Conclusion At 12 weeks, erenumab was efficacious on functional outcomes in patients with EM in whom 2–4 preventives were not useful.
Trial registration details ClinicalTrials.gov identifier: NCT03096834.
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Contributors UR, PJG and JK participated in the design of the study. The chief investigators were UR, PJG, ML-M and MDF. PH-Z participated in patient data collection. SW was the study biostatistician responsible for the statistical analyses. All authors were involved in interpretation of the data. All authors agreed on the content of the manuscript, reviewed drafts and approved the ﬁnal version.
Funding The complete study was supported by Novartis Pharma AG, Basel, Switzerland.
Competing interests ML-M received grants and honoraria for advisory boards, speaker panels or investigation studies from Allergan, Amgen, Astellas, ATI, BMS, Boehringer, Boston Scientific, CoLucid, Convergence, GlaxoSmithKline, Grunenthal, Eli Lilly, Medtronic, Menarini, MSD, Novartis, Pfizer, Reckitt Benckiser, Saint-Jude, Sanofi-Aventis, Teva Pharmaceuticals, UCB and Zambon; PJG, received grants and personal fees from Amgen and Eli Lilly; personal fees from Alder Biopharmaceuticals, Allergan, Autonomic Technologies Inc, Dr Reddy’s Laboratories, Electrocore, eNeura, MundiPharma, Novartis, Teva Pharmaceuticals, Trigemina Inc, WL Gore, MedicoLegal work, Massachusetts Medical Society, Up-to-Date, Oxford University Press and Wolters Kluwer; and a patent for magnetic stimulation for headache assigned to eNeura without fee; UR received consulting fees, speaking/teaching fees and/or research grants from Allergan, Amgen, Autonomic Technologies, CoLucid, ElectroCore, Eli Lilly, Medscape, Novartis, StreamMedUp and Teva Pharmaceuticals; SW, PH-Z and JK are employees of, and hold stocks in, Novartis; MDF received grants, consultancy or trial support from Medtronic, ElectroCore, Amgen, Eli Lilly, Teva Pharmaceuticals and Novartis, and independent support from the European Community, NWO, NIH and the Dutch Heart Foundation.
Patient consent for publication Not required.
Data availability statement Data are available upon reasonable request. All data relevant to the study are included in the article or uploaded as supplementary information. The data for the analyses described in this report are available by request from the author investigators or Novartis and/or Amgen, the companies sponsoring the clinical development of erenumab for the treatment of migraine.
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