Abstract
BackgroundGalcanezumab is a calcitonin gene-related peptide (CGRP) monoclonal antibody (mAb) indicated for the preventive treatment of migraine. While galcanezumab has demonstrated efficacy in patients who did not respond to prior preventive medications in general, its efficacy in patients who did not benefit from individual, commonly prescribed preventive treatments due to inadequate efficacy or safety/tolerability remains unknown.MethodsCONQUER was a 3-month, randomized, double-blind, placebo-controlled, phase 3b study that enrolled patients with episodic or chronic migraine who had 2 to 4 migraine preventive medication category failures in the past 10 years. Patients were randomly assigned 1:1 to receive placebo (N = 230) or galcanezumab 120 mg/month (240 mg loading dose; N = 232). Post hoc analyses were conducted to determine the efficacy of galcanezumab in patients who had not benefited from six of the most commonly prescribed migraine preventive medications. The mean change from baseline in monthly migraine headache days and ≥ 50 % response rates were assessed over months 1–3. Improvement in Migraine-Specific Questionnaire Role Function-Restrictive (MSQ-RFR) scores were assessed at month 3. The endpoints were estimated via mixed model with repeated measures.ResultsThe most common treatment failures due to inadequate efficacy or safety/tolerability, which at least 20 % of patients reported trying without benefit, included topiramate, amitriptyline, propranolol, valproate or divalproex, onabotulinum toxin A, and metoprolol. Patients who had not previously benefited from these treatments had a greater mean reduction in monthly migraine headache days across months 1–3 in the galcanezumab group compared to placebo (all p < 0.01). More patients treated with galcanezumab experienced a ≥ 50 % reduction from baseline in monthly migraine headache days across months 1–3 compared to placebo (all p < 0.05). Galcanezumab-treated patients had a greater improvement in mean MSQ-RFR scores at month 3 compared to placebo (all p < 0.01).ConclusionsIn this population, galcanezumab was effective in reducing monthly migraine headache days, improving response rates, and enhancing quality of life in patients who had not previously benefited from topiramate, amitriptyline, propranolol, valproate or divalproex, onabotulinum toxin A, and/or metoprolol due to inadequate efficacy or safety/tolerability.Trial registrationClinicalTrials.gov NCT03559257 (CONQUER).
Highlights
Migraine is a chronic neurologic disease characterized by moderate-to-severe headaches with associated symptoms including nausea, vomiting, photophobia, or phonophobia that can be disabling [1]
The six most commonly failed migraine preventive medications in CONQUER, which at least 20 % of patients reported trying without adequate efficacy or tolerability, were topiramate, amitriptyline, propranolol, valproate or divalproex, onabotulinum toxin A, and metoprolol
50% response rates A greater proportion of patients treated with galcanezumab who previously did not benefit from the six most commonly failed preventive medications in CONQUER experienced a ≥ 50 % reduction relative to baseline in monthly migraine headache days across months 1–3 compared to placebo
Summary
Migraine is a chronic neurologic disease characterized by moderate-to-severe headaches with associated symptoms including nausea, vomiting, photophobia, or phonophobia that can be disabling [1]. The most commonly prescribed migraine preventive medication classes are antiepileptics (e.g., topiramate), beta blockers (e.g., propranolol), and tricyclic antidepressants (e.g., amitriptyline), none of which were developed for the preventive treatment of migraine [3, 4]. Previous studies that assessed adherence to migraine standard-of-care treatments found that 6 months after treatment initiation with antidepressants, antiepileptics, or beta blockers, 68–73 % of patients were no longer taking these medications for migraine prevention [6]. While galcanezumab has demonstrated efficacy in patients who did not respond to prior preventive medications in general, its efficacy in patients who did not benefit from individual, commonly prescribed preventive treatments due to inadequate efficacy or safety/tolerability remains unknown
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