| アブストラクト | INTRODUCTION: Through 2018, three calcitonin gene-related peptide pathway-targeted monoclonal antibodies (CGRP mAbs) had received US Food and Drug Administration (FDA) approval for migraine prevention: erenumab, fremanezumab, and galcanezumab. METHODS: This retrospective analysis evaluated adverse events (AEs) spontaneously reported to the FDA Adverse Event Reporting System (FAERS) safety surveillance database during the first 6 months post-approval of erenumab (May 2018 to November 2018), fremanezumab (September 2018 to March 2019), and galcanezumab (September 2018 to March 2019). Reporting rates (RR) per 1000 exposed patients were calculated from number of reported events (when product classified as "primary suspect") in each AE category and estimated number of treated patients based on de-identified prescription data (IQVIA database) and were ranked on the basis of frequency for each product. RESULTS: RR per 1000 exposed patients for "migraine" (erenumab, 4.89; fremanezumab, 1.01; galcanezumab, 2.99), "headache" (3.32, 1.27, 3.07), and "drug ineffective" (3.68, 1.14, 1.69) were commonly reported for all three products, as were migraine-associated symptoms ("nausea": 2.94, 0.91, 1.09) and "injection-site" reactions ("pain": 2.94, 0.8, 4.9; "swelling": 0.56, 0.53, 1.25; "pruritus": 0.26, 0.63, 1.14; "erythema": 0.58, 0.71, 1.58). "Constipation" ranked second for erenumab (4.90) but did not make the top ten events for fremanezumab (0.46) or galcanezumab (0.76); cardiovascular events did not rank in the top ten AEs for any product. The frequency of serious outcomes was low, with </= 2% of AEs categorized as serious across the CGRP mAbs. CONCLUSION: These results aid in supporting the safety profile of CGRP mAbs in the real-world setting and may provide clinicians and patients with additional insight when considering migraine preventive treatments. |
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| ジャーナル名 | Advances in therapy |
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| 投稿日 | 2022/11/10 |
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| 投稿者 | Silberstein, Stephen D; Reshef, Shoshana; Cohen, Joshua M; Gandhi, Sanjay; Seminerio, Michael; Ramirez Campos, Verena; Kessler, Yoel; Thompson, Stephen F; Blumenfeld, Andrew |
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| 組織名 | Jefferson Headache Center, Thomas Jefferson University, 900 Walnut Street, Second;Floor, Philadelphia, PA, 19107, USA. Stephen.Silberstein@jefferson.edu.;Epidemiology and Global Health and Economics Research, Teva Pharmaceutical;Industries, West Chester, PA, USA.;Global Medical Affairs, Teva Pharmaceutical Industries, West Chester, PA, USA.;North American Medical Affairs, Teva Pharmaceutical Industries, West Chester, PA,;USA.;Pharmacovigilance and Patient Safety, Teva Pharmaceutical Industries, West;Chester, PA, USA.;The Headache Center of Southern California, The Neurology Center, Carlsbad, CA, |
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| Pubmed リンク | https://www.ncbi.nlm.nih.gov/pubmed/36350532/ |
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