Effectiveness of galcanezumab versus topiramate, amitriptyline, and other select traditional oral migraine preventives with evidence of efficacy: 3‐Month results from the TRIUMPH study

Objective: To compare the 3-month effectiveness of galcanezumab with select traditional oral migraine preventive (TOMP) medications recommended by scientific societies (TOMP efficacy subset) and with the most frequently used individual TOMP medications. Background: Multiple TOMP medications (within classes of beta-blockers, anticonvulsants, tricyclic antidepressants, angiotensin II receptor antagonists, and calcium channel blockers) originally developed to treat other conditions are used for migraine prevention. In a recent real-world analysis comparing galcanezumab with a broader classification of TOMP, a significantly greater proportion of patients treated with galcanezumab achieved a clinically meaningful response at 3 months (reduction from baseline in monthly migraine headache days) (46.6% vs. 34.5%, p < 0.001). Treatment selection is often individualized based on patients' historical and current clinical profiles, preferences, and comorbid conditions. Comparing the real-world effectiveness of galcanezumab with specific TOMP using stringent criteria based on established efficacy at a global level will provide additional insights. Methods: The TRIUMPH (preventive TReatment of mIgraine: oUtcoMes for Patients in real-world Healthcare systems) study is an ongoing, international, prospective observational cohort study comparing the effectiveness of galcanezumab with other preventives (EUPAS33068). A priori sample size was achieved, and interim data (Feb 25, 2020, to Feb 9, 2023) were analyzed. The current analysis compared patients with migraine initiating galcanezumab versus the TOMP efficacy subset (drugs with established/probable efficacy based on the 2021 American Headache Society consensus statement incorporating the American Academy of Neurology classification of evidence and consistent with the European Headache Federation/European Academy of Neurology and Japanese Society of Neurology/Japanese Headache Society). Galcanezumab was also compared with the most frequently used individual TOMP drugs in the TRIUMPH study. Reduction in monthly migraine headache days (≥50%: episodic migraine, ≥30%: chronic migraine) from baseline to 3 months was assessed after adjusting for baseline cohort differences. Results: At the time of this analysis, 2398 patients from the United States, Japan, Germany, Italy, the United Kingdom, Spain, and the United Arab Emirates had completed baseline assessments. Topiramate (n = 343) and amitriptyline (n = 240) were the most frequently used TOMP drugs. At 3 months, the galcanezumab cohort (n = 1065) had a greater weighted proportion of responders versus the TOMP efficacy subset (n = 916) (48.3% [95% confidence interval [CI]: 45.1%, 51.6%] vs. 35.9% [95% CI: 32.6%, 39.3%]; p < 0.001), topiramate (n = 343) (48.8% [95% CI: 45.7%, 51.9%] vs. 37.2% [95% CI: 31.2%, 43.7%]), and amitriptyline (n = 240) (49.7% [95% CI: 46.6%, 52.8%] vs. 23.3% [95% CI: 17.5%, 30.4%]) cohorts. Conclusion: In this real-world study, galcanezumab induced a clinically meaningful reduction in migraine headache days in a higher proportion of patients than TOMP medications classified as efficacious, including topiramate and amitriptyline. Trial Registration Number: EUPAS33068.