Interim Analysis of CONFIDENCE: A ProspeCtive ObservatioNal Study with Acute Treatment oF rImegepant ODT on ConsistENcy, SatisfaCtion and Tolerability of TrEatment in the Real World
Lucy Abraham1, Alexandre Urani2, Giorgio Lambru3, Richard Lipton4, Peter Goadsby5, Patricia Pozo-Rosich6, Todd Schwedt7, Boryana Galabova1, Feng Dai8, Karin Hygge Blakeman9
1Pfizer R&D UK Ltd, Tadworth, Surrey, 2Aptar Digital Health, Paris, France, 3The Headache and Facial Pain Service, Guy's and St. Thomas' NHS Foundation Trust, London, UK, 4Montefiore Medical Center and Albert Einstein College of Medicine, New York, USA, 5NIHR-Wellcome Trust King’s Clinical Research Facility, King’s College Hospital/SLaM Biomedical Research Centre, King’s College London, UK and UCLA, Los Angeles, CA, USA, 6Headache and Neurological Pain Research Group, Vall d'Hebron Research Institute, Universitat Autònoma de Barcelona; Headache and Craniofacial Pain Unit, Neurology Department, Vall d'Hebron University Hospital, Barcelona, Spain, 7Department of Neurology, Mayo Clinic, Scottsdale, Arizona, USA, 8Pfizer, Inc., New York, NY USA, 9Pfizer AB., Stockholm, Sweden
Objective:

Evaluate real-world effectiveness of rimegepant as an acute migraine treatment over multiple attacks.

Background:

Assessment of real-world effectiveness is important to evaluate the impact of new treatments outside of clinical trials.  

Design/Methods:

This prospective, real-world observational study of adults currently using rimegepant to treat migraine attacks was conducted using the Migraine Buddy® app. Eligible participants had 3-14 headache days within the last 30 days and planned to treat some future attacks with rimegepant.  Participants completed a: 1) baseline survey capturing demographic/clinical characteristics and current treatments; 2) 28-day daily diary assessing time to meaningful pain relief (pain reduced to a degree the patient considers meaningful), time to normal function, and treatment satisfaction; and 3) questionnaire at study completion. Effectiveness was evaluated for treated attacks over 28-days.

Results:

Of participants included (n = 146), 140 treated at least one attack with rimegepant during the study. Participants were 92.5% female, 93.8% Caucasian, with mean (SD) age of 40.1 (11.1). Migraine burden was high at study start: mean (SD) headache days in the past 30 days was 7.4 (3.0); 87% had MIDAS scores ≥11, indicating moderate-to-severe disability; 65% were using a preventive treatment, most frequently mAbs. A total of 1054 attacks were recorded in diaries; rimegepant was used to treat 706 (67.0%) attacks. The median number of attacks treated by individuals was 5 (3-6 IQR). For rimegepant-treated attacks, the proportion achieving meaningful improvements in pain and ability to function within 2 hours was 58.6% and 56.4%, respectively. For 67.3% of rimegepant-treated attacks, participants were ‘satisfied’ or ‘extremely satisfied’, overall. Meaningful pain relief was achieved within 2 hours for the first (63.6%), second (58.2%), third (59.2%), and fourth (60.0%) rimegepant-treated attacks

Conclusions:

Meaningful pain relief and restoration of function occurred within 2 hours for the majority of attacks with high levels of population consistency from attack to attack.  

10.1212/WNL.0000000000210369
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