| Abstract: |
Atogepant is approved for migraine prevention and has shown strong efficacy in clinical trials. However, its effectiveness following failure of anti-CGRP monoclonal antibodies (MAbs) has not been evaluated in large real-world populations. This multicenter observational study conducted across Spanish headache units included adults with migraine who initiated atogepant after failure of ≥ 1 anti-CGRP MAb and had ≥ 3 months of follow-up. Baseline demographic and clinical variables were collected prospectively, with follow-up assessments at months 3 and 6. The primary outcome was the proportion of patients achieving a ≥ 50% reduction in monthly migraine days (MMD) at three months. Secondary outcomes included ≥ 30%, ≥ 75%, and 100% response rates; changes in headache days, pain intensity, acute medication use, and patient-reported outcomes; adverse events; treatment persistence; and factors associated with response. A total of 252 patients were included (mean age 48. 9 ± 12 years; 83. 3% female; 80. 6% with chronic migraine; 45. 6% with continuous daily headache). Prior to atogepant, 39. 7% had failed one anti-CGRP MAb, 27. 0% two, 20. 2% three, and 13. 1% four. Median baseline MMD was 16, monthly headache days 27, and acute medication days 20. At 3 months, 44. 4% achieved a ≥ 30% reduction in MMD, 29. 7% ≥50%, and 11. 7% ≥75%. Adverse events were reported in 52. 5% of patients, most commonly constipation (30%) and nausea (25%). At three months, 26. 2% had discontinued treatment (65. 1% due to inefficacy, 28. 8% due to intolerance). Treatment persistence at 180 days was 61% (95% CI 54 to 69%). A higher number of previously failed MAbs was independently associated with reduced odds of ≥ 50% response (RR 0. 79, 95% CI 0. 64 to 0. 97). Moreover, a higher number of previously failed MAbs was associated with diminished improvements across multiple clinical endpoints, including headache frequency, intensity, acute medication use, and disability measures. Atogepant may represent a viable treatment option for patients with migraine who have failed anti-CGRP MAbs. In this large real-world cohort, approximately one-third of patients achieved a ≥ 50% response, despite a treatment-refractory profile. However, the likelihood of response decreases with a higher number of previously failed MAbs, and mild adverse events are frequent. The online version contains supplementary material available at 10. 1186/s10194-025-02239-1. The online version contains supplementary material available at 10. 1186/s10194-025-02239-1. |
guest ::
(Hospital Universitari de Bellvitge)
