Real-world treatment patterns of galcanezumab versus traditional oral migraine preventives: 12-month results from the TRIUMPH study

Background This study describes 12-month treatment patterns in patients with migraine who initiated/switched to galcanezumab (GMB), a calcitonin gene-related peptide monoclonal antibody (CGRP mAb), or traditional oral migraine preventive (TOMP) medications. Methods This multi-country, prospective, real-world, observational, TRIUMPH (TReatment of mIgraine: oUtcoMes for Patients in real-world Healthcare systems) study assessed treatment patterns, index drug discontinuation, and acute medication use. “Negative reasons” for discontinuation or switch were defined as lack of efficacy, drug intolerability or drug unavailability. Time to treatment discontinuation was estimated using Kaplan-Meier methods and log-rank test. Hazard ratios and confidence intervals (95% CI) were determined using weighted Cox proportional hazards models. Results Among 2486 patients, 973 received GMB and 1138 received TOMP (mean [standard deviation] age: 45.2 [13.6] and 40.4 [13.2] years, respectively). Approximately 70.0% and 59.8% of patients in GMB and TOMP cohorts, respectively, had chronic migraine at baseline. Approximately, 37.3% of patients in the GMB cohort had used ≥ 3 prior preventive medications compared with 4.5% in TOMP cohort, reflecting greater treatment refractoriness at baseline. At 12 months, treatment discontinuation rates were lower in GMB than in TOMP cohort for negative reasons (12.7% versus 17.4%; P =0.0022) and all-causes (17.8% versus 23.2%; P =0.0025). The weighted hazard ratios (95% CI) for discontinuation due to negative reasons and all-cause reasons were 0.53 (0.41, 0.68) and 0.57 (0.46, 0.70), P <0.0001, respectively. The weighted mean change in number of migraine headache days (MHDs) using acute medication declined in both GMB and TOMP cohorts from baseline to 3 months (-5.1 versus -3.4; P <0.0001), 6 months (-5.1 versus -4.2; P =0.0234), and 12 months (-5.3 versus -4.3; P =0.0168). Persistence rates were similar between GMB and TOMP cohorts, with mean exposure of 9.3 ± 4.1 and 9.4 ± 3.9 months, respectively. However, GMB cohort had fewer combination treatments, switches, and more often used subsequent line of other CGRP mAbs compared to TOMP cohort. Conclusions In this prospective real-world study, discontinuation of and combination with other preventive medications were less frequent in GMB cohort compared to TOMP cohort. There was a larger reduction in MHDs requiring acute medication in patients initiating/switching to GMB compared to TOMP. Trial Registration The trial was registered on June 21, 2019, at the European Network of Centres for Pharmacoepidemiology and Pharmacovigilance with the identifier EUPAS33068.