Blumenfeld Andrew M, Mechtler Laszlo, Cook Lisa, Rhyne Christopher, Jenkins Brian, Hughes Olivia, Dabruzzo Brett, Manack Adams Aubrey, Diamond Merle
The Los Angeles Headache Center, Los Angeles, CA, USA.
The San Diego Headache Center, San Diego, CA, USA.
Pain Ther. 2024 Dec;13(6):1571-1587. doi: 10.1007/s40122-024-00649-8. Epub 2024 Sep 17.
Combination use of atogepant and onabotulinumtoxinA has the potential to be more effective than either alone for the preventive treatment of chronic migraine (CM) due to their complementary mechanisms of action. This analysis collected real-world data to evaluate the safety, tolerability, and effectiveness of adding atogepant to onabotulinumtoxinA as a combination preventive treatment for CM.
This retrospective, longitudinal, multicenter chart review included adults with CM who received ≥ 2 consecutive cycles of onabotulinumtoxinA before ≥ 1 month of onabotulinumtoxinA and atogepant combination treatment. Charts at atogepant prescription (index date) and two subsequent onabotulinumtoxinA treatment visits (~ 3 and ~ 6 months post-index) were reviewed for change from baseline in monthly headache days (MHDs), ≥ 50% reduction in MHDs, discontinuation rates, and adverse events (AEs).
Of the 55 charts that met safety analysis criteria, 31 had data on headache days at index and first post-index visit and were eligible for effectiveness analysis (mean age 46.7 years, 94.5% female). For those with data available prior to onabotulinumtoxinA treatment (n = 25), the mean MHD was 24.0 days, reduced by 8.15 days after onabotulinumtoxinA treatment. After atogepant was added, MHD was incrementally reduced by 4.53 days and 8.75 days from index date to the first (N = 31) and second (N = 23) post-index onabotulinumtoxinA treatment visit, respectively. A ≥ 50% reduction in MHDs was achieved by 45.2% of patients ~ 3 months post-index. Atogepant and onabotulinumtoxinA were discontinued by 16.1% and 6.5% of patients, respectively. In the safety population, 32.7% of patients experienced ≥ 1 AE. No serious AEs were reported.
This real-world study of patients with CM demonstrated that adding atogepant to onabotulinumtoxinA as a combination preventive treatment for CM was effective by providing an additional reduction in MHDs over ~ 3 and ~ 6 months of combination treatment. Safety results were consistent with the known safety profiles of onabotulinumtoxinA and atogepant, with no new safety signals identified.
阿托格潘与A型肉毒毒素联合使用，因其互补的作用机制，在慢性偏头痛（CM）的预防性治疗中可能比单独使用任何一种药物更有效。本分析收集了真实世界的数据，以评估在A型肉毒毒素基础上加用阿托格潘作为CM联合预防性治疗的安全性、耐受性和有效性。
这项回顾性、纵向、多中心图表审查纳入了患有CM的成年人，这些患者在接受≥1个月的A型肉毒毒素和阿托格潘联合治疗之前，连续接受了≥2个周期的A型肉毒毒素治疗。审查了阿托格潘处方时（索引日期）以及随后两次A型肉毒毒素治疗访视（索引日期后约3个月和6个月）的图表，以了解每月头痛天数（MHD）相对于基线的变化、MHD减少≥50%的情况、停药率和不良事件（AE）。
在符合安全性分析标准的55份图表中，31份在索引日期和索引后首次访视时有头痛天数的数据，有资格进行有效性分析（平均年龄46.7岁，94.5%为女性）。对于在A型肉毒毒素治疗前有可用数据的患者（n = 25），平均MHD为24.0天，A型肉毒毒素治疗后减少了8.15天。加用阿托格潘后，从索引日期到索引后首次（N = 31）和第二次（N = 23）A型肉毒毒素治疗访视时，MHD分别进一步减少了4.53天和8.75天。约45.2%的患者在索引日期后约3个月时MHD减少≥50%。分别有16.1%和6.5%的患者停用了阿托格潘和A型肉毒毒素。在安全人群中，32.7%的患者经历了≥1次AE。未报告严重AE。
这项针对CM患者的真实世界研究表明，在A型肉毒毒素基础上加用阿托格潘作为CM联合预防性治疗是有效的，在联合治疗的约3个月和6个月内，MHD进一步减少。安全性结果与A型肉毒毒素和阿托格潘已知的安全性特征一致，未发现新的安全信号。
