Background: Patients with migraine aged ≥65 years old are underrepresented in clinical trials. This study compares effectiveness, excellent response, and tolerability of galcanezumab in patients ≥65 years and those younger than 65 years, specifically assessing age as a predictor of response.
Methods: This real-life, multicenter cohort study included patients with chronic or high-frequency episodic migraine who did not respond to more than or equal to three preventive drugs, treated with galcanezumab, and followed for 12 months from 12 Spanish hospitals, between November 2019 and January 2022. Effectiveness was defined as ≥50% reduction in monthly headache days (MHD), and excellent response as ≥75% reduction at 6 months. Tolerability was based on the percentage of patients discontinuing due to adverse events.
Results: We included 1055 patients (934 patients <65 years, 121 patients ≥65 years). Older patients had higher baseline MHD [25 (interquartile range [IQR] 15-30) vs. 20 (14-30), p = 0.045], but lower HIT-6 scores [67 (IQR 63-72) vs. 69 (66-73), p < 0.001]. Effectiveness was similar across age groups at 3 (57.0% vs. 48.8%, p = 0.090), 6 (57.0% vs. 51.8%, p = 0.281), and 12 months (52.1% vs. 51.4%, p = 0.889). However, excellent response was more frequent in the ≥65 years group at 3 months (32.2% vs. 23.1%, p = 0.028) and 6 months (33.9% vs. 23.5%, p = 0.012), with a non-significant difference at 12 months (33.1% vs. 25.4%, p = 0.071). Tolerability was comparable within age groups (5.8% discontinuation due to adverse effects in patients ≥65 years vs. 6.7% in patients <65 years; p = 0.837). Age was independently associated with effectiveness (adjusted odds ratio [aOR]: 1.02; 95% confidence interval [CI]: 1.004-1.03) and excellent response (aOR: 1.02; 95% CI: 1.01-1.04). A statistically significant association was found in the logistic regression model for excellent response when age was dichotomized at 65 years, with increasing age linked to a higher likelihood of an excellent treatment response (aOR: 1.79; 95% CI: 1.13-2.82, p = 0.012).
Conclusions: Galcanezumab is as effective and well-tolerated in patients aged ≥65 years as in younger patients but older patients showed a higher rate of excellent response. Age is associated with a better response to galcanezumab.
Keywords: calcitonin gene‐related peptide; effectiveness; excellent response; migraine prevention; monoclonal antibodies; real‐world study.
© 2025 The Author(s). Headache: The Journal of Head and Face Pain published by Wiley Periodicals LLC on behalf of American Headache Society.