OC07 | LONG-TERM COMBINATION WITH ONABOTULINUMTOXINA AND ATOGEPANT TO ACHIEVE HIGHER STANDARDS OF MIGRAINE CONTROL: A 52-WEEK, PROSPECTIVE, REAL-WORLD EVALUATION (SYNERGY STUDY)

L. Francesco Iannone¹, M. Romozzi^2|3, A. Russo⁴, I. Finkelstein⁵, D. Seabi⁶, A. Ahlden⁶, A. Hege Aamodt^7|8|9, P. Calabresi^2|3, C. Vollono³, E. Caronna^10|11, P. Pozo-Rosich^10|11, E. Andreas Tronvik^8|12|13, C. Sundal^6|12 | ¹Department of Biomedical, Metabolic and Neural Sciences, University of Modena and Reggio Emilia, Italy; ²Dipartimento Universitario di Neuroscienze, Università Cattolica del Sacro Cuore, Rome, Italy; ³Neurologia, Dipartimento di neuroscienze, Organi di Senso e Torace, Fondazione Policlinico Universitario Agostino Gemelli IRCCS, Rome, Italy; ⁴Inter-departmental Program of Headache Medicine and Primary Pain Syndromes, Department of Medical, Surgical, Neurological, Metabolic and Aging Sciences, University of Campania “Luigi Vanvitelli”, Naples, Italy; ⁵Toronto Headache and Pain clinic; Pain Clinic, Toronto, Canada; ⁶NeuroClinicNorway, Lillestrøm, Norway; ⁷Department of Neurology, Oslo University Hospital, Rikshospitalet, Norway; ⁸NorHead, Norwegian Headache Research Centre; NTNU, Norwegian University of Science and Technology, Trondheim, Norway; ⁹Institute of Population Health, Faculty of Health and Life Sciences, University of Liverpool, UK; ¹⁰Headache and Neurological Pain Research Group, Vall d’Hebron Research Institute, Department of Neuroscience, Universitat Autònoma de Barcelona, Spain; ¹¹Headache Clinic, Neurology Department, Vall d’Hebron Hospital, Barcelona, Spain; ¹²Department of Neuromedicine and Movement Science, Norwegian University of Science and Technology, Trondheim, Norway; ¹³Neuroclinic, St. Olavs Hospital, Trondheim, Norway

Abstract

Background. Patients with chronic migraine (CM) who remain inadequately controlled despite ongoing preventive monotherapy represent a particularly challenging population. Whether the clinical benefit achieved after adding a second preventive therapy can be maintained over the long term remains poorly understood. Herein, we evaluated the 52-week real-world effectiveness of onabotulinumtoxinA (BoNT-A) plus atogepant in the expanded SYNERGY study.
Methods. We prospectively analyzed 143 adults with CM receiving atogepant added to stable BoNT-A (prior exposure mean 11.8±6.7 months), regardless to prior anti-calcitonin gene-related peptide (CGRP) drugs exposure. Outcomes were assessed at baseline and weeks 12, 24, 36, and 52. Co-primary outcomes were change in monthly migraine days (MMDs) from baseline to week 52 and ≥50% MMDs response (RR50%). Secondary outcomes included monthly headache days (MHDs), acute medication days, HIT-6 and effectiveness using the IHS recommendations at 52 weeks. Sensitive analysis were performed including patients that discontinued treatment. All participants give written informed consent.
Results. Participants were mostly female (134/143, 93.7%, mean age±SD, 41.0±11.3) and 88/143 (61.5%) had prior anti-CGRP monoclonal antibody exposure. Baseline MHDs and MMDs were 22.9 ± 5.7 and 16.6 ± 6.6 days, respectively.At week 52, in the 115 patients completing the follow up, MMDs decreased to 8.2±5.8 days (χ²(4)=199.5, p<0.001), with reductions versus baseline at all time points (all p<0.001) and RR50% was achieved by 63/108 patients (58.3%). IHS-defined modest or optimal control was achieved by 21/108 (19.4%) and 27/108 (25.0%) individuals respectively. None achieved migraine freedom. In prior anti-CGRP monoclonal antibody failures (n=88), MMDs decreased from 16.7±6.9 to 8.8±6.1 days and RR50% was achieved by 37/67 (55.2%). Discontinuation increased from 8/143 (5.6%) at week 12 to 35/143 (24.5%) at week 52, mainly due to ineffectiveness.
Conclusions. Atogepant add-on to BoNT-A was associated with sustained MMDs reductions over 52 weeks. IHS categories showed that one quarter of subjects achieved optimal control, supporting long-term evaluation of combination prevention in CM with high residual migraine burden.