Effects of Galcanezumab on Health-Related Quality of Life and Disability in Patients with Previous Failure of 2-4 Migraine Preventive Medication Categories: Results from a Phase IIIb Randomized, Placebo-Controlled, Multicenter Clinical Trial (CONQUER)

Abstract

Background and objectives: Patients with migraine and prior preventive treatment failures have a significant burden on quality of life and disability. The CONQUER study evaluated the effects of galcanezumab on patient functioning, disability, and health status in episodic or chronic migraine with a previous failure of two to four migraine preventive medication categories.

Methods: Patients with two to four preventive migraine treatment category failures received galcanezumab 120 mg/month (240-mg loading dose) or placebo subcutaneously, for 3 months (double-blind period). In the 3-month open-label period, all patients received galcanezumab irrespective of the treatment received in the double-blind period. Changes in Migraine-Specific Quality of Life Questionnaire version 2.1 (MSQ), Migraine Disability Assessment (MIDAS), and European Quality of Life-5 Dimensions-5 Levels (EQ-5D-5L) scores were assessed.

Results: A total of 462 patients were randomized to receive galcanezumab (N = 232) or placebo (N = 230). At month 3, improvement in the MSQ Role-Function-Restrictive score from baseline was significantly greater for galcanezumab (23.19 ± 1.34) vs placebo (10.66 ± 1.33) [p ≤ 0.0001]. Significant improvements in remaining MSQ domains and total MSQ scores were observed (p < 0.0001) during the double-blind period. MIDAS total scores were significantly (p ≤ 0.0001) reduced with galcanezumab (- 21.10 + 3.32) vs placebo (- 3.30 + 3.28). EQ-5D-5L visual analog scale scores improved for galcanezumab (3.40 + 1.31) vs placebo (- 0.09 + 1.29; p = 0.028). During the open-label period, quality of life continued to improve for galcanezumab, with patients previously assigned to placebo reaching similar results. During both study periods, similar findings were reported in subpopulations with episodic migraine and chronic migraine.

Conclusions: Galcanezumab significantly improved functioning and reduced disability in patients with episodic migraine and chronic migraine and two to four migraine preventive treatment category failures.

Clinical trial registration: NCT03559257, registration date: 6 June, 2018.

Conflict of interest statement

SJT received grants for research (no personal compensation) from Allergan, Amgen, Eli Lilly, Lundbeck, Neurolief, Novartis, Satsuma, and Zosano; served as a consultant and/or on advisory boards (honoraria) for Aeon, Align Strategies, Allergan/Abbvie, Alphasights, Amgen, Aperture Venture Partners, Aralez Pharmaceuticals Canada, Axsome Therapeutics, Becker Pharmaceutical Consulting, BioDelivery Sciences International, Biohaven, ClearView Healthcare Partners, CRG, Currax, Decision Resources, DeepBench, Eli Lilly, Equinox, ExpertConnect, GLG, Guidepoint Global, Healthcare Consultancy Group, Health Science Communications, HMP Communications, Impel, Lundbeck, M3 Global Research, Magellan Rx Management, Medicxi, Navigant Consulting, Neurolief, Nordic BioTech, Novartis, Pulmatrix, Reckner Healthcare, Relevale, SAI MedPartners, Satsuma, Slingshot Insights, Spherix Global Insights, Sudler and Hennessey, Synapse Medical Communications, Teva, Theranica, Thought Leader Select, Trinity Partners, XOC, and Zosano; received a salary from Dartmouth-Hitchcock Medical Center, American Headache Society, and Thomas Jefferson University; and received CME honoraria from the American Academy of Neurology, American Headache Society, Cleveland Clinic Foundation, Diamond Headache Clinic, Elsevier, Forefront Collaborative, Hamilton General Hospital, Ontario, Canada, Headache Cooperative of New England, Henry Ford Hospital, Detroit, Inova, Medical Learning Institute Peerview, Medical Education Speakers Network, Miller Medical Communications, North American Center for CME, Physicians’ Education Resource, Rockpointe, ScientiaCME, and WebMD/Medscape. JA has received honoraria for consulting from Amgen, Abbvie, Biohaven, Eli Lilly and Company, Lundbeck, Teva, Impel, Satsuma, Theranica, Axsome, and Vorso; received stock options from CtrlM for consulting; honoraria for speaking engagements from Abbvie, Amgen, Biohaven, Eli Lilly, Lundbeck, and Teva; provided advising and editorial services and received honoraria from Current Pain and Headache Reports, SELF, Neurology Live, and Medscape; and engaged in CME with Avent, Pri-Med, Forefront, Medscape, Clinical Care Options, Academy for Continued Healthcare Learning, Answers in CME , and NeurologyLive. JA’s institution has received funding for clinical trials for her work as a principal investigator from Allergan/Abbvie, Biohaven, Eli Lilly and Company, Satsuma, and Zosano. JHF, RMN, LQL, PK, and AT-H hold stocks, and are employees at Eli Lilly and Company. ALH is an employee at IQVIA.

© 2022. The Author(s).

Figures

Fig. 1

Least-squares (LS) mean change (standard error [SE]) from baseline to month 6. (A) Role Function-Restrictive (RF-R), (B) Role Function-Preventive (RF-P), (C) Emotional Function (EF), and (D) Migraine-Specific Quality of Life Questionnaire (MSQ) version 2.1 total scores. Values presented for total placebo (PBO) and total galcanezumab (GMB) populations for double-blind and open-label periods. In the open-label period, all patients were treated with GMB, including the patients who received PBO in the double-blind period. EM episodic migraine, **p < 0.0001 for comparison between total PBO and total GMB populations; #values for the GMB population in the open-label period

Fig. 2

Least-squares (LS) mean change from baseline in Migraine Disability Assessment (MIDAS) total scores at (A) month 3 and (B) month 6. In the open-label period, all patients were treated with galcanezumab (GMB), including the patients who received placebo (PBO) in the double-blind period. CM chronic migraine, EM episodic migraine, *p < 0.01; **p ≤ 0.0001; #p < 0.05 vs PBO. The error bars represent standard error

Fig. 3

Least-squares (LS) mean change from baseline in the EQ-5D-5L Visual Analog Scale scores at (A) month 3 and (B) month 6. In the open-label period, all patients were treated with galcanezumab (GMB), including the patients who received placebo (PBO) in the double-blind period. CM chronic migraine, EM episodic migraine, #p < 0.05 vs PBO. The error bars represent standard error