Treatment effectiveness of galcanezumab versus traditional oral migraine preventive medications at 3 months: Results from the TRIUMPH study.

Objective: This study assesses the 3-month effectiveness of the calcitonin gene-related peptide monoclonal antibody galcanezumab versus traditional oral migraine preventive medications.

Background: Studies comparing the effectiveness of calcitonin gene-related peptide monoclonal antibodies versus traditional oral migraine preventive medications are limited. However, such comparisons in real-world settings are useful for decision-making by patients, healthcare providers, and policymakers.

Methods: TRIUMPH is an ongoing, international, prospective observational cohort study of adult patients with migraine, initiating or switching to new preventive medication with a focus on galcanezumab versus traditional oral migraine preventive medications. Data for this analysis were collected from February 25, 2020, through February 9, 2023. All treatment decisions were at the physicians' discretion. The primary outcome was a 3-month response based on reductions in physician-recorded monthly migraine headache days: ≥50% (episodic migraine) or ≥30% (chronic migraine). The difference in the proportion of responders between treatments was assessed after adjusting for baseline cohort differences.

Results: Of 2813 patients, 1105 received galcanezumab and 1293 received traditional oral migraine preventive medications. The weighted response rate at 3 months was greater with galcanezumab versus traditional oral migraine preventive medications (46.6% vs. 34.5%; p < 0.001). Additional 3-month mean changes from baseline for galcanezumab versus traditional oral migraine preventive medications included a reduction in monthly migraine headache days (-5.7 [95% confidence interval (CI), -6.2 to -5.2] vs. -4.1 [95% CI, -4.5 to -3.7]), and an improvement in Migraine-Specific Quality of Life-Role Function Restrictive score (19.4 [95% CI, 17.6-21.3] vs. 10.2 [95% CI, 8.6-11.8]), respectively (both p < 0.001).

Conclusion: Findings from this study showed that patients receiving galcanezumab had greater treatment effectiveness after 3 months than those receiving traditional oral migraine preventive medications across multiple measures, including migraine headache days, various responder rate thresholds, change in Migraine-Specific Quality of Life-Role Function Restrictive scores, and types of migraine. These findings are representative of clinical practice settings and may help physicians in making treatment decisions.