Galcanezumab in Patients with Multiple Previous Migraine Preventive Medication Category Failures: Results from the Open-Label Period of the CONQUER Trial

Abstract

Introduction: Results from the open-label extension of the phase 3b CONQUER trial are presented to evaluate the effectiveness and safety of galcanezumab, a monoclonal antibody targeting calcitonin gene-related peptide, for up to 6 months in patients with multiple prior migraine preventive treatment failures.

Methods: Patients were 18-75 years old with episodic or chronic migraine and 2-4 standard-of-care migraine preventive medication category failures. After 3 months of randomized treatment with galcanezumab (120 mg/month with 240 mg loading dose; n = 232) or placebo (n = 230), patients entered a 3-month open-label extension (120 mg/month galcanezumab with a blinded 240 mg loading dose for previous-placebo patients). Primary efficacy measure was mean change from double-blind baseline in monthly migraine headache days.

Results: A total of 432/449 patients (96%) who entered open-label treatment completed the study. Mean change in monthly migraine headache days in the total population, which was - 1.3 for placebo and - 4.4 for galcanezumab patients at the end of double-blind treatment (p < 0.001), was - 5.2 and - 5.6, respectively, at the end of open-label treatment with galcanezumab. Among patients with episodic migraine, mean change in monthly migraine headache days had been - 0.6 for placebo and - 2.8 for galcanezumab after double-blind treatment (p < 0.001) and was - 4.5 and - 3.8, respectively, after open-label treatment. Among patients with chronic migraine, mean change in monthly migraine headache days had been - 2.5 for placebo and - 6.6 for galcanezumab after double-blind treatment (p < 0.001) and was - 6.5 and - 8.2, respectively, after open-label treatment. Adverse events were similar to those observed during double-blind placebo treatment. Review of data in elderly patients (65-75 years of age) indicated that galcanezumab was well tolerated in this age group, with no safety issues identified.

Conclusions: Galcanezumab was effective and safe during open-label treatment in patients who had experienced failures of previous migraine preventives.

Clinical trial registration: ClinicalTrials.gov identifier NCT03559257.

Keywords: CGRP; Chronic migraine; Elderly; Episodic migraine; Galcanezumab; Migraine preventive; Monoclonal antibody; Treatment failure.

© 2021. The Author(s).

Figures

Fig. 1

Patient disposition: flow chart illustrating the numbers of patients continuing to open-label treatment and the numbers and reasons for patients discontinuing participation during the open-label period

Fig. 2

Mean change from baseline in monthly migraine headache days: Mean changes in monthly migraine headache days for the 3-month double-blind and 3-month open-label periods are shown for all patients (a), patients with episodic migraine (b), and patients with chronic migraine (c). GMB galcanezumab, GMB/GMB galcanezumab treatment in double-blind and open-label periods, LS least squares, PBO/GMB placebo treatment in double-blind and galcanezumab treatment in open-label periods, SE standard error. **p < 0.001, *p < 0.05 compared to PBO/GMB

Fig. 3

Patients with ≥ 50%, ≥ 75%, and 100% reductions from baseline in monthly migraine headache days at months 3 and 6: Bars show model-estimated rates of patients experiencing ≥ 50%, ≥ 75%, and 100% decreases from baseline in monthly migraine headache days for the total population (a), patients with episodic migraine (b), and patients with chronic migraine (c) at month 3 (end of double-blind period) and month 6 (end of open-label period) for both treatment arms. For the chronic migraine population with 100% decrease, raw rates are shown at 3 months as a result of non-convergence of the model because zero placebo-treated patients met the response threshold for this time point. GMB/GMB galcanezumab treatment in double-blind and open-label periods, PBO/GMB placebo treatment in double-blind and galcanezumab treatment in open-label periods, standard error. ***p < 0.001, **p < 0.01, *p < 0.05 compared to PBO/GMB