Effectiveness of rimegepant across multiple acute migraine attacks: A real-world, prospective, multicentric study
Gloria Vaghi, Raffaele Ornello, Gabriele Sebastianelli, Francesco Casillo, Antonio Russo, Marcello Silvestro, Francesca Pistoia, Gennaro Saporito, Giorgio Dalla Volta, Marco Bolchini, Andrea Burgalassi, Antonio Munafò, Danilo Antonio Montisano, Licia Grazzi, Maria Pia Prudenzano, Davide Mascarella, Gianluca Coppola, Edoardo Mampreso, Gianluca Avino, Catello Vollono, Marina Romozzi, Mariarosaria Valente, Giovanna Carlucci, Simona Guerzoni, Stefania Battistini, Antonio Granato, Elisa Maria Piella, Innocenzo Rainero, Maria Albanese, Michele Trimboli, Alberto Doretti, Federico De Santis, Simona Sacco, Cristina Tassorelli, Luigi Francesco Iannone, Matteo Cortinovis, Alberto Chiarugi, Francesco De Cesaris, Martino Gentile, Adriana Fallacara, Sabina Cevoli, Enrico Grassi, Sara Pez, Flavia Lo Castro, Luca Bartole, Alessia Agostinelli, Chiara Serafini, Vittoria Carla D’Agostino, Eleonora Colombo, Alessandro Cocuzza, Roberto De IccoAim
Rimegepant is an effective acute migraine treatment, with limited evidence regarding its consistency across multiple migraine attacks. The primary aim is to assess rimegepant effectiveness across multiple migraine attacks.
Methods
In this real-world, prospective, multicentric study we assessed participants who treated up to four different migraine attacks with rimegepant 75 mg orally disintegrating tablet. Data was collected every 30 min from migraine onset up to 2 h post dose using an electronic diary. Our primary outcome was 2-h pain freedom across all-treated attacks; secondary outcomes were: consistency of response (percentage of participants who achieved 2-h pain freedom in at least two treated attacks), safety and tolerability.
Results
We enrolled 191 participants (80.1% females, age 44.8 [43.2–46.5] years, disease duration 28.4 [25.0–31.8] years, 27.7% with chronic migraine, 9.6 [8.9–10.9] baseline monthly migraine days-MMDs). We collected data from 377 migraine attacks (191 first-treated, 110 s-treated, 46 third-treated and 30 fourth-treated). Two-hour pain freedom was achieved in 44.6% (168/377) of treated attacks [39.3–49.6]. After correction for age, timing of rimegepant intake, baseline pain intensity, ongoing preventive treatment, and number of preventive drug classes that previously proved ineffective, 2-h pain freedom was associated with female sex (odds ratio (OR) = 2.3 [1.2–4.3], p = 0.012), no ongoing mAbs treatment (OR = 3.2 [1.6–6.4], p = 0.001), and lower MMDs (OR = 1.05 [1.0–1.1], p = 0.002). Consistency of response was 36.4% [27.3–45.5] (40/110). Participants reporting at least one adverse event were 11.5% (22/191).
Conclusion
Our study confirms the effectiveness of rimegepant in nearly half of treated attacks and describe the consistency of response in a relatively large real-world population where one out of five participants achieved 2-h pain freedom in all-treated migraine attacks. No new safety signals were identified.