Real-World Meta-Analysis Confirms Efficacy and Safety of CGRP Treatment Galcanezumab in Migraine

In a meta-analysis of real-world studies newly published in Headache, findings showed that galcanezumab (Emgality; Eli Lilly), an approved calcitonin gene-related peptide (CGRP)-blocking medication, demonstrated efficacy in reducing frequency of migraine and headache days, while maintaining a favorable safety profile among patients with chronic or episodic migraine. Although the certainty of evidence was limited by heterogeneity across studies, the findings suggest that galcanezumab may serve as an effective and well-tolerated option in clinical migraine management.¹

Across the 36 studies and 3859 patients with migraine, galcanezumab was associated with reductions in monthly migraine days (MMD) and monthly headache days (MHD) from 1 to 12 months of treatment (MMD, −6.93 to −10.90; MHD, −8.55 to −10.97). Progressive improvements were also observed in functional and disability measures, including the Headache Impact Test–6 score (−7.96 to −11.97) and the Migraine Disability Assessment Scale score (−42.61 at 3 months; −50.52 to −55.17 from 6 to 12 months).

Led by Jaime Fernández-Bravo-Rodrigo, PharmD, a hospital pharmacy specialist at the Virgen del Castillo Hospital in Yecla, the study summarized and pooled real-world evidence on the clinical efficacy and safety of galcanezumab in patients with migraine. Researchers conducted a systematic search from databases including PubMed, Scopus, and Web of Science from inception to February 2025. Studies included in the meta-analyses assessed the real-world effects of galcanezumab on MMDs, MHDs, Headache Impact Test, Migraine Disability Assessment Scale, number of days in medication, acute monthly intake, pain intensity, and safety outcomes.

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Researchers also observed additional reductions in the number of days on acute migraine-specific medication (NDM, −6.79 to −13.01), acute monthly intake (AMI, −11.85 to −19.35), and pain intensity (PI, −2.04 at 1 month; −1.67 to −2.29 from 3 to 12 months). Authors reported that approximately two-thirds of patients achieved at least a 50% response rate in MMD or MHD at 3 to 6 months, one-third achieved at least a 75% response rate, and 2% to 7% achieved complete a response.

In terms of safety, the pooled prevalence of any adverse event (AE) was 0.23 (95% CI, 0.07–0.44), 0.25 (95% CI, 0.14–0.38), and 0.35 (95% CI, 0.27–0.45) at 3, 6, and 12 months, respectively. Notably, constipation was the most commonly reported AE, with pooled prevalence estimates of 0.06 (95% CI, 0.02–0.11) at 3 months and 0.16 (95% CI, 0.06–0.29) at 6 months. Overall, authors noted that the safety findings indicated that AEs were generally mild and occurred at low rates.

All told, demographic factors had limited impact on the reported efficacy and safety of galcanezumab, although age was associated with changes in Headache Impact Test–6 scores. Authors noted that higher baseline values were linked to greater reductions in MMDs, Migraine Disability Assessment Scale scores, number of days on medication, and acute monthly intake. Moreover, some outcomes showed smaller improvements in patients with medication overuse or in female patients. Researchers also observed that studies conducted in Europe reported slightly larger reductions, whereas episodic migraine had no significant effect.

Galcanezumab was approved by the FDA in September 2018 for the preventive treatment of migraine in adults and is the only CGRP monoclonal antibody with response rates in the episodic migraine headache population on at least 50%, 75% and 100% reduction from baseline in monthly migraine headache days over 1 to 6 months. Following the approval, its indication expanded in June 2019 to include the treatment of episodic cluster headache, a rare form of headache that produces extreme pain and tends to occur in clusters, often at the same time(s) of the day, for several weeks to months.²

REFERENCES
1. Fernández-Bravo-Rodrigo J, Pascual-Morena C, Saz-Lara A, et al. Real-world effectiveness and safety of galcanezumab for the treatment of migraine: A systematic review and meta-analysis. Headache. Published online November 17, 2025. doi:10.1111/head.70003
2. FDA approves first treatment for episodic cluster headache that reduces the frequency of attacks. News release. FDA. June 4, 2019. Accessed November 25, 2025. https://www.fda.gov/news-events/press-announcements/fda-approves-first-treatment-episodic-cluster-headache-reduces-frequency-attacks