Galcanezumab in Patients with Multiple Previous Migraine Preventive Medication Category Failures: Results from the Open-Label Period of the CONQUER Trial
Uwe Reuter, Christian Lucas, David Dolezil, Austin L Hand, Martha D Port, Russell M Nichols, Chad Stroud, Antje Tockhorn-Heidenreich, Holland C Detke, Uwe Reuter, Christian Lucas, David Dolezil, Austin L Hand, Martha D Port, Russell M Nichols, Chad Stroud, Antje Tockhorn-Heidenreich, Holland C Detke
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).
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Source: PubMed