OC18 | LONG-TERM EFFECTIVENESS, SAFETY AND TOLERABILITY OF ATOGEPANT IN THE PREVENTION OF MIGRAINE: A MULTICENTRIC, PROSPECTIVE OBSERVATIONAL, REAL WORLD STUDY (THE 48-WEEK STAR STUDY)
F. Vernieri1|2, L. Francesco Iannone3, M. Marcosano1|2, L. Fofi1, F. Lo Castro4, G. Sebastianelli5, F. De Santis6, M. Corrado7, R. Ornello6, L. Grazzi8, D. Antonio Montisano8, F. De Cesaris9, A. Munafò9, G. Avino10, M. Trimboli11, M. Albanese12, A. Russo13, M. Silvestro13, G. Dalla Volta14, M. Romozzi15, P. Calabresi15, A. Boccalini4, P. Merlo16, M. Pia Prudenzano17, M. Rosaria Valente18, I. Rainero19, G. Giuliani20, M. Altieri20, A. Doretti21, G. Vaghi7|22, F. Pistoia6, D. Ferrandi23, S. Battistini24, G. Coppola5, S. Guerzoni4, S. Sacco6|25, C. Tassorelli7|22, C. Altamura1|2 | 1Headache and Neurosonology Unit, Fondazione Policlinico Universitario Campus Bio-Medico, Roma, Italy; 2Department of Medicine and Surgery, Università Campus Bio-Medico di Roma, Italy; 3Department of Biomedical, Metabolic and Neural Sciences, University of Modena and Reggio Emilia, Italy; 4Digital and Predictive Medicine, Pharmacology and Clinical Metabolic Toxicology-Headache Center and Drug Abuse-Laboratory of Clinical Pharmacology and Pharmacogenomics, AOU Policlinico Di Modena, Italy; 5Sapienza University of Rome, Department of Medico-Surgical Sciences and Biotechnologies, Polo Pontino, Latina, Italy; 6Department of Biotechnological and Applied Clinical Sciences, University of L’Aquila, Italy; 7Headache Science and Neurorehabilitation Centre, IRCCS Mondino Foundation, Pavia, Italy; 8Headache Center IRCCS Fondazione Istituto Neurologico "Carlo Besta", Italy; 9Headache center and clinical pharmacology, AOU Careggi, Firenze, Italy; 10Neurology Unit, Ospedale Santo Stefano, USL Toscana Centro, Prato, Italy; 11Azienda Ospedaliera-universitaria "Renato Dulbecco", Catanzaro, Italy; 12Department of Systems Medicine, University of Rome Tor Vergata, Italy; 13Headache Center, Department of Medical, Surgical, Neurological, Metabolic and Aging Sciences, Second University of Naples, Italy; 14U.O Neurologia, Istituto Clinico Città di Brescia, Gruppo San Donato, Italy; 15Fondazione Policlinico Universitario A. Gemelli IRCCS, Università Cattolica del Sacro Cuore, Roma, Italy; 16UO di Neurologia, Humanitas Gavazzeni, Bergamo, Italy; 17Clinica Neurologica "L. Amaducci", Azienda Ospedaliero-Universitaria Consorziale Policlinico di Bari, Italy; 18Clinica Neurologica ASUFC, Dipartimento di Medicina DMED Università di Udine, Italy; 19Headache Center, Department of Neuroscience, University of Torino, Italy; 20Department of Human Neuroscience, Sapienza University of Rome, Italy; 21IRCCS Istituto Auxologico Italiano, Milano, Italy; 22Department of Brain and Behavioural Sciences, University of Pavia, Italy; 23SC Neurologia, Azienda Ospedaliero Universitaria Santi Antonio e Biagio, Alessandria, Italy; 24Department of Medical, Surgical and Neurological Sciences, University of Siena, Italy; 25Neurology and Stroke Unit, ASL 1 Abruzzo, Avezzano-Sulmona-L’Aquila, Italy
Abstract
Background. To investigate the long-term effectiveness, safety and tolerability of atogepant for migraine prevention after 48 weeks of treatment.
Methods. At baseline (T0), weeks 9–12 (T3), 21–24 (T6) and 45-48 weeks (T12), monthly migraine days (MMDs), and main patients’ reported outcomes were assessed. The co-primary outcomes were changes in MMDs and the percentage of MMDs ≥50% responders (50%RR) at T3, T6, and T12 compared to baseline. We also reported the proportion of patients achieving migraine freedom according to the International Headache Society proposal.
Results. Three hundred and seventy (370) patients from 17 Italian centers were enrolled (female 311, 84.1%, age 47.7 SD 0.7). Of these, 57 patients (15.4%) dropped out of treatment within the first 12 weeks; 85 (23.0%) within 24 weeks; and 118 (31.9%) within 48 weeks. Nineteen participants (16,1%) dropped out because of adverse events, 43 (36,4%) for inefficacy, 14 (11,9%) for both adverse events and inefficacy, and 42 (35,6%) for other reasons.In patients continuing therapy for 48 weeks, MMDs decreased from 16.5 (SD 0.5) to 7.8 (SD 0.5; p<0.001) at T3, 7.6 (SD 0.5) at T6, 7.9 (SD 0.5) at T12, while 50%RR was achieved in 52% of patients at T3, 48.1% at T6, and 43.3% at T12. At all evaluation times, patients affected by chronic migraine less frequently achieved 50%RR (p<0.01). Migraine freedom was achieved in 6.2% of patients at T3, 7.1%, at T6, and 8.4% at T12.Pain NRS reduced from baseline (8 IQR 1) to T3 (6 IQR 2, p<0.001) and remained stable until T12. The MIDAS scores almost halved from 64.9 at baseline (SD 47.8) to 23.9 (SD 32.1) at T12.Overall, patients’ weight progressively decreased from baseline to T12 (p<0.001) and a clinically relevant (i.e.>7%) weight loss was observed in 43.9% of participants at T3, 47.2% at T6, and 50.0% at T12. No correlation was observed between clinical response and weight loss at all observation times.
Conclusions. The STAR study demonstrates the sustained effectiveness and tolerability of atogepant over 48 weeks. Discontinuations and weight loss support the need for long-term monitoring in clinical practice and treatment optimization.
On behalf of the Italian Headache Registry (RICe) Study Group.
Methods. At baseline (T0), weeks 9–12 (T3), 21–24 (T6) and 45-48 weeks (T12), monthly migraine days (MMDs), and main patients’ reported outcomes were assessed. The co-primary outcomes were changes in MMDs and the percentage of MMDs ≥50% responders (50%RR) at T3, T6, and T12 compared to baseline. We also reported the proportion of patients achieving migraine freedom according to the International Headache Society proposal.
Results. Three hundred and seventy (370) patients from 17 Italian centers were enrolled (female 311, 84.1%, age 47.7 SD 0.7). Of these, 57 patients (15.4%) dropped out of treatment within the first 12 weeks; 85 (23.0%) within 24 weeks; and 118 (31.9%) within 48 weeks. Nineteen participants (16,1%) dropped out because of adverse events, 43 (36,4%) for inefficacy, 14 (11,9%) for both adverse events and inefficacy, and 42 (35,6%) for other reasons.In patients continuing therapy for 48 weeks, MMDs decreased from 16.5 (SD 0.5) to 7.8 (SD 0.5; p<0.001) at T3, 7.6 (SD 0.5) at T6, 7.9 (SD 0.5) at T12, while 50%RR was achieved in 52% of patients at T3, 48.1% at T6, and 43.3% at T12. At all evaluation times, patients affected by chronic migraine less frequently achieved 50%RR (p<0.01). Migraine freedom was achieved in 6.2% of patients at T3, 7.1%, at T6, and 8.4% at T12.Pain NRS reduced from baseline (8 IQR 1) to T3 (6 IQR 2, p<0.001) and remained stable until T12. The MIDAS scores almost halved from 64.9 at baseline (SD 47.8) to 23.9 (SD 32.1) at T12.Overall, patients’ weight progressively decreased from baseline to T12 (p<0.001) and a clinically relevant (i.e.>7%) weight loss was observed in 43.9% of participants at T3, 47.2% at T6, and 50.0% at T12. No correlation was observed between clinical response and weight loss at all observation times.
Conclusions. The STAR study demonstrates the sustained effectiveness and tolerability of atogepant over 48 weeks. Discontinuations and weight loss support the need for long-term monitoring in clinical practice and treatment optimization.
On behalf of the Italian Headache Registry (RICe) Study Group.
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