Effect of erenumab on functional outcomes in patients with episodic migraine in whom 2-4 preventives were not useful: results from the LIBERTY study

Abstract

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.

Conflict of interest statement

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.

© Author(s) (or their employer(s)) 2021. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.

Figures

Figure 1

Mean change from baseline in HIT-6. Adjusted mean change (SE) reported. HIT-6, Headache Impact Test; TD, treatment difference.

Figure 2

Change from baseline in WPAI scores and subscores at Week 12. Adjusted mean reported. A negative change in WPAI score indicates an improvement in the work productivity domain. TD, treatment difference; WPAI, Work Productivity and Activity Impairment.