The 3 calcitonin gene-related peptide (CGRP) inhibitors that have been approved thus far for the prevention of migraine since 2018 —erenumab, fremanezumab, and galcanezumab— showed a reassuring safety profile in a real-world setting . Post-marketing data of the first 6 months following their marketing launch was reported.
Included in this retrospective analysis were adverse events (AEs) that were spontaneously reported to the FDA during the first 6 months post-approval and that were likely to be treatment-related. Many of the reported AEs were injection-site reactions, such as pain, pruritus, rash, and erythema. Migraine, headache, and drug ineffectiveness were reported for all 3 medications. Constipation ranked second for erenumab, but was not in the top 10 of AEs for fremanezumab or galcanezumab. Cardiovascular events were not among the top 10 AEs for any of the products. The top 5 reporting rates (RRs) per 1,000 patients exposed for each of the 3 CGRP inhibitors were:
- erenumab: wrong technique (4.97), constipation (4.90), migraine (4.89), accidental exposure (4.83), and drug ineffectiveness (3.68);
- fremanezumab: headache (1.27), drug ineffectiveness (1.14), migraine (1.01), nausea (0.91), and injection-site pain (0.81);
- galcanezumab: injection-site pain (4.90), under-dose (3.86), headache (3.07), migraine (2.99), and drug ineffectiveness (1.69).
These observations were as expected based upon the clinical trial results. Longer-term safety data, such as those on the approved CGRP inhibitors, has been eagerly awaited, since there are theoretical cardiovascular concerns especially in patients with coronary disease.
Disease area: Headache & Migraine
- Silberstein SD, et al. Abstract S58.008, AAN 2020.
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