Real-World Effectiveness and Tolerability of Rimegepant as Second- or Third-Line Acute Treatment for Migraine: A Prospective Observational Study

Rimegepant is an oral calcitonin gene-related peptide receptor antagonist approved for both acute and preventive treatment of migraine. However, limited information is available regarding its effectiveness and tolerability when used as a second- or third-line acute treatment in patients for whom triptans and/or lasmiditan are ineffective, poorly tolerated, contraindicated, or otherwise unsuitable. This study evaluated the effectiveness and tolerability of rimegepant in this real-world clinical setting. A prospective observational study was conducted in 89 patients (76 female; mean age 40.6 ± 12.2 years) prescribed rimegepant 75 mg after prior use of triptans and/or lasmiditan. Participants self-recorded headache intensity using a visual analog scale (VAS) before and 2 and 4 h after taking rimegepant. Pain freedom was defined as a VAS score of 0, and treatment efficacy as a ≥ 50% reduction in VAS score. The Patient Global Impression of Change (PGIC) was assessed at 2 h. Continuation was defined as a request for ongoing prescription after the initial dose. The study population included 35 patients (39.3%) with chronic migraine and 65 (73.0%) with prior calcitonin gene-related peptide (CGRP) monoclonal antibody exposure. Median VAS scores decreased from 77.0 at baseline to 18.0 at 2 h and 0.0 at 4 h (p < 0.001). Pain-free rates were 24.7% (95% CI 16.2–35.0%) at 2 h and 52.8% (95% CI 41.9–63.5%) at 4 h. Efficacy rates (≥ 50% VAS reduction) were 68.5% and 87.6% at 2 and 4 h, respectively. The continuation rate was 82.0%. Meaningful improvement on the PGIC was reported by 65.2% of patients. Adverse events occurred in 13.5% of patients. No adverse events leading to treatment discontinuation were observed. Rimegepant was associated with clinically meaningful pain relief and favorable patient-reported outcomes when used as a second- or third-line acute treatment in real-world clinical practice. Migraine is a common neurological disorder that can cause severe headache and substantially affect daily activities, work productivity, and quality of life. Triptans are commonly used to treat migraine attacks, but some patients cannot use them because they are ineffective, cause adverse effects, are contraindicated because of cardiovascular conditions, or are otherwise unsuitable. Lasmiditan is another treatment option, but some patients experience adverse effects or choose not to use it. Rimegepant is an oral calcitonin gene-related peptide (CGRP) receptor antagonist approved for both acute and preventive treatment of migraine. However, limited information is available regarding its effectiveness in patients who have previously used triptans and/or lasmiditan and require an alternative treatment option. In this prospective real-world study, we evaluated 89 adults with migraine who received rimegepant as a second- or third-line acute treatment. We found that 24.7% of patients were pain-free within 2 h of taking rimegepant, and 52.8% were pain-free within 4 h. Overall, 82.0% of patients chose to continue treatment after their first use of rimegepant. Adverse events occurred in a small proportion of patients, and no adverse events leading to treatment discontinuation were observed. These findings suggest that rimegepant may be an effective and well-tolerated treatment option for patients with migraine who do not achieve satisfactory outcomes with triptans and/or lasmiditan in routine clinical practice.