Pharmacotechnology Documentation and Transfer Unit, Preclinical and Translational Pharmacology, Department of Pharmacy, Health and Nutritional Sciences, University of Calabria, 87036 Rende, Italy.
Regional Center for Serious Brain Injuries, S. Anna Institute, 88900 Crotone, Italy.
Toxins (Basel). 2022 Aug 1;14(8):529. doi: 10.3390/toxins14080529.
OnabotulinumtoxinA, targeting the CGRP machinery, has been approved for the last two decades for chronic migraine prevention. The recently approved monoclonal antibodies (mAbs) directed towards the calcitonin gene-related peptide (CGRP) pathway open a new age for chronic migraine control. However, some 40% patients suffering from chronic migraine is still resistant to treatment. The aim of this work is to answer the following PICOS (participants intervention comparator outcome study design) question: Is there evidence of efficacy and safety of the combined administration of anti-CGRP mAbs and onabotulinumtoxinA in chronic migraine? A systematic review and meta-analysis [Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) 2020 recommendations] was made up to 19 April 2022. The results are encouraging: the combined treatment proved to afford ≥50% monthly headache days (MHDs)/frequency reduction respect to baseline in up to 58.8% of patients; in comparison, anti-CGRP mAbs reduce MHDs of 1.94 days from baseline and botulinum toxin of 1.86 days. Our study demonstrates for the first time that the combination therapy of onabotulinumtoxinA with anti-CGRP mAbs affords a reduction of 2.67 MHDs with respect to onabotulinumtoxinA alone, with moderate certainty of evidence. Adequately powered, good-quality studies are needed to confirm the response to combination therapy in terms of efficacy and safety. PROSPERO registration: CRD42022313640.
肉毒杆菌毒素 A 针对降钙素基因相关肽 (CGRP) 机制，在过去二十年中已被批准用于预防慢性偏头痛。最近批准的针对降钙素基因相关肽 (CGRP) 途径的单克隆抗体 (mAb) 为慢性偏头痛控制开辟了一个新时代。然而，约 40%的慢性偏头痛患者对治疗仍有耐药性。本研究旨在回答以下 PICOS（参与者、干预、比较、结局、研究设计）问题：联合使用抗 CGRP mAb 和肉毒杆菌毒素 A 治疗慢性偏头痛是否有疗效和安全性证据？系统评价和荟萃分析[系统评价和荟萃分析的首选报告项目 (PRISMA) 2020 建议]截至 2022 年 4 月 19 日。结果令人鼓舞：联合治疗在高达 58.8%的患者中证明可提供≥50%的每月头痛天数 (MHDs)/基线频率减少；相比之下，抗 CGRP mAb 可使基线时的 MHDs 减少 1.94 天，肉毒杆菌毒素减少 1.86 天。我们的研究首次证明，与单独使用肉毒杆菌毒素 A 相比，肉毒杆菌毒素 A 联合抗 CGRP mAb 治疗可使 MHDs 减少 2.67 天，证据质量为中等。需要进行足够有力、高质量的研究来证实联合治疗在疗效和安全性方面的反应。PROSPERO 注册：CRD42022313640。
