SafeTy and effectiveness of Atogepant accoRding to the IHS outcome categories: A multicentric, prospective observational study in real life (the 24-week STAR study).
Claudia Altamura, Luigi Francesco Iannone, Flavia Lo Castro, Gabriele Sebastianelli, Marilena Marcosano, Federico De Santis, Michele Corrado, Raffaele Ornello, Licia Grazzi, Danilo Antonio Montisano, Francesco De Cesaris, Antonio Munafò, Gianluca Avino, Michele Trimboli, Maria Albanese, Antonio Russo, Marcello Silvestro, Giorgio Dalla Volta, Marina Romozzi, Paolo Calabresi, Alberto Boccalini, Paola Merlo, Maria Pia Prudenzano, Maria Rosaria Valente, Innocenzo Rainero, Giada Giuliani, Marta Altieri, Luisa Fofi, Alberto Doretti, Gloria Vaghi, Francesca Pistoia, Delfina Ferrandi, Stefania Battistini, Gianluca Coppola, Simona Guerzoni, Simona Sacco, Cristina Tassorelli, Fabrizio Vernieri
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引用次数: 0
Abstract
BackgroundThe improved prevention of migraine, driven by the introduction of calcitonin gene-related peptide (CGRP)-targeted therapies, has prompted the International Headache Society (IHS) to propose new goals in migraine management. This study aimed to evaluate the safety and effectiveness of atogepant for migraine prevention over 24 weeks, in accordance with the IHS-defined goals.MethodsThis is a multicenter, prospective, observational, real-world study on patients starting atogepant 60 mg for migraine prevention. We describe efficacy and safety outcomes at weeks 9-12 (T3) and 21-24 (T6) relative to baseline (T0) from the initiation of atogepant treatment. We also report the proportion of patients achieving migraine freedom, optimal, modest or insufficient control according to the IHS position paper categories.ResultsOne hundred twenty-eight (n = 128) patients (63 (49.2%) with chronic migraine, 115 (89.9%) female, aged 48.3 ± 13.3 years) from 17 centers were analyzed. Monthly migraine days decreased from 16.5 ± 8.5 at T0 to 8.0 ± 8.4 at T3 (p < 0.001 vs. T0) and 8.6 ± 9.2 at T6 (p < 0001 vs. T0, p = 0.265 compared to T3). Overall, 64.8% of patients were responders (at least 50% reduction in monthly migraine days from T0) at T3 and 61.7% at T6; 81.9% of responders at T3 maintained the responder status at T6, while 24.4% of patients among non-responders at T3 became responders at T6. At T3 and T6, 39.1% of the entire cohort achieved at least optimal migraine control (20.6% in chronic migraine and 56.9% in episodic migraine).ConclusionsThe STAR study demonstrates, in a real-world setting, the safety and the sustained effectiveness of atogepant 60 mg over 24 weeks and indicates that more than one-third of treated patients can achieve at least optimal disease control, with markedly better outcomes in episodic than in chronic migraine.Trial RegistrationThe study was preregistered on clinicaltrial.gov, NCT06414044.
背景：随着降钙素基因相关肽（CGRP）靶向治疗的引入，偏头痛的预防得到了改善，这促使国际头痛学会（IHS）提出了偏头痛治疗的新目标。本研究的目的是根据ihs定义的目标，在24周内评估联合剂预防偏头痛的安全性和有效性。方法：这是一项多中心、前瞻性、观察性、真实世界的研究，研究对象是开始服用60mg抗偏头痛药物的患者。我们描述了9-12周（T3）和21-24周（T6）相对于基线（T0）的疗效和安全性结果。我们还报告了根据IHS立场文件类别实现偏头痛自由，最佳，适度或不充分控制的患者比例。结果分析了来自17个中心的128例慢性偏头痛患者（63例（49.2%），其中女性115例（89.9%），年龄48.3±13.3岁）。每月偏头痛天数从T0时的16.5±8.5天减少到T3时的8.0±8.4天（与T3相比p p = 0.265）。总体而言，在T3和T6时，64.8%的患者有反应（每月偏头痛天数从T0至少减少50%）；T3时81.9%的应答者在T6时维持应答状态，而T3时无应答者中24.4%的患者在T6时成为应答者。在T3和T6时，整个队列中39.1%的患者至少达到了最佳偏头痛控制（慢性偏头痛20.6%，发作性偏头痛56.9%）。STAR研究表明，在现实环境中，atgeatat60mg超过24周的安全性和持续有效性，并表明超过三分之一的治疗患者至少可以达到最佳的疾病控制，发作性偏头痛的结果明显优于慢性偏头痛。试验注册该研究已在clinicaltrial.gov上预注册，编号NCT06414044。
期刊介绍：
Cephalalgia contains original peer reviewed papers on all aspects of headache. The journal provides an international forum for original research papers, review articles and short communications. Published monthly on behalf of the International Headache Society, Cephalalgia''s rapid review averages 5 ½ weeks from author submission to first decision.
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