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 standardof-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.

Safety and tolerability of erenumab in individuals with episodic or chronic migraine across age groups: a pooled analysis of placebo-controlled trials

“…Notably, pooled subgroup analysis assessing the safety profile of fremanezumab in participants aged ≥ 60 years reported comparable findings with the overall pooled population [ 33 ]. Furthermore, the CONQUER study, which enrolled patients aged 18‒75 years, found no clinically significant safety findings for AEs, laboratory analytes, vital signs, or ECGs in the subgroup of patients aged 65‒75 years treated with galcanezumab, albeit the sample size was low ( N = 29) [ 34 ]. While this provides preliminary evidence that use of CGRP mAbs may be safe in individuals beyond 65 years, real-life studies in larger populations of older individuals are needed.…”

Open-label trials for CGRP-targeted drugs in migraine prevention: A narrative review

“…In the DBTP, 462 patients with episodic or chronic migraine were randomly assigned to placebo or galcanezumab 120 mg (with a loading dose of 240 mg) (25). Of the 451 patients who completed the DBTP, all but two patients entered the OLE and 96% completed the study (26). The previous placebo group started the OLE with a blinded loading dose of 240 mg and reported a reduction of −3.9 MMD in the first OLE month (26).…”

“…Of the 451 patients who completed the DBTP, all but two patients entered the OLE and 96% completed the study (26). The previous placebo group started the OLE with a blinded loading dose of 240 mg and reported a reduction of −3.9 MMD in the first OLE month (26). Both groups reported thereafter similar reductions with 120 mg galcanezumab monthly (26).…”

Calcitonin Gene-Related Peptide (CGRP)-Targeted Monoclonal Antibodies and Antagonists in Migraine: Current Evidence and Rationale

“…When stratifying by EM and CM, galcanezumab achieved a MMD reduction of − 2.88 and − 5.90, respectively. OLE data of CONQUER reported galcanezumab achieved a MMD reduction of − 5.6 in the galcanezumab continuous group, and − 5.2 in those who switched from placebo to galcanezumab [ 56 ].…”