Numbers needed to treat or harm and likelihood of being helped versus harmed for fremanezumab in patients who had prior inadequate response to two to four classes of migraine preventive medications: A post hoc analysis
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Objective: This study aimed to determine the number needed to treat (NNT), number needed to harm (NNH), and likelihood of being helped or harmed (LHH) in a post hoc analysis of the phase 3b FOCUS trial. Background: Fremanezumab, a humanized monoclonal antibody that selectively targets calcitonin gene–related peptide (CGRP), has demonstrated efficacy, tolerability, and safety in adults with episodic migraine (EM) or chronic migraine (CM), with documented previous inadequate response to two to four classes of migraine preventive medications. Methods: In the 12-week double-blind period of the FOCUS study, patients were randomized (1:1:1) to quarterly fremanezumab, monthly fremanezumab, or matched monthly placebo. NNT was based on responder analysis, defined as ≥50% reduction in monthly average number of migraine days at 12 weeks. NNH was based on discontinuations due to adverse events (AEs). Results: Among patients with CM (n = 509), response rates and discontinuation rates were 27% (45/169) and 0 for quarterly fremanezumab, 29% (50/173) and 2% (3/173) for monthly fremanezumab, and 8% (13/167) and <1% (1/167) for placebo, respectively. These results translated to NNTs of 5.3 and 4.7, NNHs of 1000 and 88, and LHHs of 188 and 19 for quarterly and monthly fremanezumab, respectively. Among patients with EM (n = 328), response rates were 47% (50/107) for quarterly fremanezumab, 43% (47/110) for monthly fremanezumab, and 10% (11/111) for placebo. Discontinuation rates were <1% (n = 1) in all three groups. These results translated to NNTs of 2.7 and 3.0, NNHs of 1000 and 1000, and LHHs of 368 and 328 for quarterly and monthly fremanezumab, respectively. Conclusions: The NNT, NNH, and LHH for quarterly and monthly fremanezumab compare favorably with those for traditional oral preventive medications, including topiramate, valproate, and propranolol.
| Originalsprog | Engelsk |
|---|---|
| Tidsskrift | Headache |
| Vol/bind | 63 |
| Udgave nummer | 10 |
| Sider (fra-til) | 1351-1358 |
| ISSN | 0017-8748 |
| DOI | |
| Status | Udgivet - 2023 |
Bibliografisk note
Funding Information:
reports personal fees from AbbVie, Amgen, Eli Lilly, Lundbeck, Novartis, and Teva Pharmaceuticals. Messoud Ashina participated in clinical trials as the principal investigator for AbbVie, Amgen, Eli Lilly, Lundbeck, Novartis, and Teva Pharmaceuticals. Messoud Ashina received a research grant from Lundbeck, Novo Nordisk Foundation, and Novartis. Messoud Ashina has no ownership interest and does not own stocks of any pharmaceutical company. Messoud Ashina serves as associate editor of , associate editor of the , and associate editor of . received grants for travel expenses, honoraria, and consultation from Allergan, Amgen, Cefaly, Eli Lily, Lundbeck, Merz, Merck‐Serono, Mylan, Novartis, Sanofi, and Teva Pharmaceuticals. Dimos D. Mitsikostas has participated as principal investigator in clinical trials for migraine sponsored by Amgen, Cefaly, Eli Lily, Merz, electroCore, Novartis, Lundbeck, and Teva Pharmaceuticals. Dimos D. Mitsikostas is co‐chair of the Headache Scientific Panel at the European Academy of Neurology and President of the Hellenic Headache Society. Dimos D. Mitsikostas is co‐author of the European Headache Federation recommendations for the use of monoclonal antibodies targeting the CGRP in migraine prevention, and he serves as associate editor for the . and are employees of Teva Pharmaceuticals. received honoraria for contribution to advisory boards or oral presentations from Lilly, Lundbeck, Novartis, Pfizer, and Teva Pharmaceuticals. The German Research Council (DFG), the German Ministry of Education and Research (BMBF), and the European Union support his headache research. Hans‐Christoph Diener serves on the editorial boards of , , and . Hans‐Christoph Diener is a member of the Clinical Trials Committee of the International Headache Society. Messoud Ashina Cephalalgia Journal of Headache and Pain Brain Dimos D. Mitsikostas Journal of Headache and Pain Verena Ramirez Campos, Steve Barash, Xiaoping Ning Hans‐Christoph Diener Cephalalgia Lancet Neurology Drugs
Funding Information:
Editorial assistance was provided by Ashley Oney, MD, of Lumanity Communications Inc. (Yardley, PA), which was in accordance with Good Publication Practice (GPP3) guidelines and funded by Teva Pharmaceuticals. The authors maintained full editorial control of the manuscript and the decision to submit it for publication.
Publisher Copyright:
© 2023 The Authors. Headache: The Journal of Head and Face Pain published by Wiley Periodicals LLC on behalf of American Headache Society.
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