Galcanezumab, a monoclonal antibody targeting calcitonin gene-related peptide, has shown efficacy in migraine prevention in clinical trials and has been included in clinical guidelines. Nonetheless, data on its real-world effectiveness are limited. TRIUMPH Europe, an ongoing prospective study, enrolled patients ≥ 18 years old with migraine from Germany, Italy, Spain, and the UK who were initiating or switching to galcanezumab or traditional oral migraine preventive medications (TOMPs) between June 2020 and February 2023. The primary end point at 3 months was the percentage of patients achieving a response in monthly headache days (MHDs) as defined by a percentage reduction of ≥ 50% for episodic migraine and ≥ 30% for chronic migraine. The TRIUMPH Europe results are descriptive, as no alpha was allocated for comparative formal hypothesis testing between treatment groups. A total of 717 patients were enrolled, with 46.0% in the galcanezumab and 40.9% in the TOMP groups. In the galcanezumab and TOMP groups, 85.8% and 85.3% of patients were women, respectively, and had a mean age of 44.4 and 36.8 years. Chronic migraine was more represented in the galcanezumab group than in the TOMP group (60.9% versus 32.4%). At baseline, mean (standard deviation SD) MHDs were 14.8 (7.2) for galcanezumab and 10.3 (5.2) days for TOMP. At 3 months, mean (SD) MHDs were 7.7 (7.4) and 6.8 (5.5) days for galcanezumab and TOMP, respectively. The 3-month weighted proportion of responders for galcanezumab and TOMP, respectively, was 63.1% and 34.9% overall, 60.7% and 29.9% for episodic migraines, and 65.0% and 42.6% for chronic migraines. Changes from baseline in the mean number of MHDs with acute medication use were −6.6 for galcanezumab and −2.9 for TOMP. After 3 months of migraine preventive treatment, the proportion of responders trended numerically higher among patients with migraine initiating/switching to galcanezumab than among those receiving TOMP. This study was registered through the European Network of Centres for Pharmacoepidemiology and Pharmacovigilance (number EUPAS33068).
Tassorelli et al. (Tue,) studied this question.