OC-05 | Mid-term effectiveness and tolerability of atogepant in the prevention of migraine: a real life, prospective, multicentric study (the STAR study)

Fabrizio Vernieri,¹ Luigi Francesco Iannone,^2,3 Gabriele Sebastianelli,⁴ Flavia Lo Castro,^2, Federico De Santis,⁵ Michele Corrado,⁶ Marilena Marcosano,¹ Raffaele Ornello,⁵ Licia Grazzi,⁷ Danilo Antonio Montisano,⁷ Francesco De Cesaris,⁸ Antonio Munafò,⁸ Gianluca Avino,⁹ Michele Trimboli,¹⁰ Maria Albanese,¹¹ Antonio Russo,¹² Giorgio Dalla Volta,¹³ Marina Romozzi,¹⁴ Paola Merlo,¹⁵ Maria Pia Prudenzano,¹⁶ Maria Rosaria Valente,¹⁷ Innocenzo Rainero,¹⁸ Giada Giuliani,¹⁹ Luisa Fofi,¹ Alberto Doretti,²⁰ Gloria Vaghi,⁶ Francesca Pistoia,⁵ Delfina Ferrandi,²¹ Stefania Battistini,²² Simona Sacco,⁵ Simona Guerzoni,² Claudia Altamura¹ on behalf of the Italian Headache Registry (RICe) Study Group | ¹Fondazione Policlinico Campus Bio-Medico, Roma; ²AOU Policlinico di Modena; ³Università di Modena e Reggio Emilia. ⁴Sapienza University of Rome Polo Pontino, Latina; ⁵University of L’Aquila; ⁶University of Pavia, Pavia, Italy and IRCCS Mondino Foundation, Pavia; ⁷IRCCS Istituto Neurologico Carlo Besta, Milano; ⁸AOU Careggi, Firenze; ⁹SOC Neurologia, Ospedale di Prato, Prato; ¹⁰Azienda Ospedaliera-universitaria "Renato Dulbecco", Catanzaro; ¹¹Università Roma Tor Vergata, Roma; ¹²Università della Campania "Luigi Vanvitelli", Napoli; ¹³U.O Neurologia, Istituto Clinico Città di Brescia, Gruppo San Donato, Brescia; ¹⁴Fondazione Policlinico Universitario A. Gemelli IRCCS, Università Cattolica del Sacro Cuore, Roma; ¹⁵UO di Neurologia, Humanitas Gavazzeni, Bergamo; ¹⁶Clinica Neurologica "L. Amaducci", Azienda Ospedaliero-Universitaria Consorziale di Bari; ¹⁷Dipartimento di Neuroscienze, Azienda Sanitaria Universitaria Integrata di Udine; ¹⁸Dipartimento di Neuroscienze, Città della Salute e della Scienza di Torino; ¹⁹Centro per la diagnosi e terapia delle cefalee, Policlinico Umberto I, Roma; ²⁰IRCCS Istituto Auxologico Italiano, Milano; ²¹AOU Alessandria; ²²University of Siena, Siena, Italy

Background: To assess the impact of atogepant in preventing migraine after 24-week of treatment.

Methods: Adult patients treated with atogepant 60 mg daily were included. At baseline (T0), after 12 (T3) and 24 weeks (T6) since atogepant first administration, monthly migraine days (MMDs), HIT-6, MIDAS, mTOQ-6, MSQ, ASC-12 and MIBS-4 scores were assessed. The co-primary endpoints were the changes in MMDs and the percentage 50%RR responders (i.e. reduction of MMDs≥50%) from T0 to T6.

Results: One hundred and twenty-eight patients (56 [43.8%] with chronic migraine [CM], 115 females [89.9%], age 48.3±13.3) completed the 24-week observation. In the whole group, MMDs reduced from 16.5±8.5 at baseline to 8.0±8.4 at T3 and 8.6±9.2 at T6, and specifically, from 12.8±7.3 at baseline to 6.1±7.1 at T3 and 5.8±7.2 at T6 in episodic migraine (EM), and from 21.1±7.6 to 10.5±9.3 at T3 and 12.2±10.3 at T6 in CM. Overall, 64.8% of patients were 50%MMDs responders at T3 and 61.7% at T6 (68.1% and 66.7% in the EM and 60.7% and 55.4% in the CM group at T3 and at T6, respectively). To note, 81.9% of responders at T3 maintained 50%RR also at T6, while 24.4% of patients among non-responders at T3 became 50%RR at T6. The 50%RR at T6 was higher in patients who had not previous ineffective anti-CGRP mAbs treatment (63.3% vs. 36.7%, p=0.027) and in those who were not on medication overuse at baseline (55.7% vs. 44.3%, p=0.046). Previous anti-CGRP mAbs failure was the only characteristic associated with the responder status in the multiple regression analysis (p=0.031). From T0 to T6 analgesic use, HIT-6, MIDAS, ASC-12, MIBS-4 and mTOQ-6 scores reduced (p<0.001), and MSQ role-function restriction increased (p<0.01). Changes mainly occurred from T0 to T3, except for MIBS-4 which also decreased from T3 to T6 (p<0.001). Since T3, only 10 subjects (7.8%) dropped out: 6 for lack of effectiveness, of these one also for poor tolerability, and 4 for patients’ decision. Weight reduced of 0.8±3.1 kg (p<0.001) from T0 to T3, while from T3 to T6 remained stable.

Conclusions: The multicentric real-world STAR study confirms atogepant effectiveness and tolerability at 24-week follow-up.