Eugeni Patrick, Rooney Megan E, Saikali Nicolas P, Niu Zhongzheng, Driessen Maurice T, Krasenbaum Lynda J, Carr Karen, Seminerio Michael J, McVige Jennifer W
Dent Neurologic Institute, 3980 Sheridan Dr., Amherst, NY, 14226, USA.
Teva Pharmaceuticals, Amsterdam, Netherlands.
Adv Ther. 2025 Feb;42(2):1207-1221. doi: 10.1007/s12325-024-03063-w. Epub 2025 Jan 8.
Fremanezumab, a monoclonal antibody (mAb) targeting the calcitonin gene-related peptide (CGRP) pathway, and gepants, small molecule CGRP receptor antagonists, are both approved for the treatment of migraine or its symptoms. This study assessed effectiveness, tolerability, and migraine-related healthcare resource utilization (HCRU) after the addition of fremanezumab for preventive migraine treatment in patients using gepants for acute treatment.
Data were extracted during a retrospective chart review from electronic medical records from the Dent Neurologic Institute. Eligible patients were ≥ 18 years old, using gepants (rimegepant or ubrogepant), who initiated fremanezumab between January 1, 2020, and May 1, 2021 (index date: date of fremanezumab initiation) and continued concomitant use of gepants and fremanezumab for ≥ 1 month (post-index; between 7-9 months of follow-up). Outcomes included monthly migraine days (MMD), adverse events (AEs), reasons for discontinuation, and migraine-related HCRU.
A total of 55 patients [female, 93%; mean (SD) age, 43.5 (13.5) years] met the inclusion criteria. All patients were diagnosed with chronic migraine. Patients had an average (SD) MMD of 15.8 (7.4) at the index date. Average (SE) change in MMD from index date to post-index was - 6.5 (1.0) days (p < 0.0001). Five patients (9.1%) experienced AEs post-index; no serious AEs (SAEs) were reported. The number of migraine-related medications used decreased from the index date to post-index by a mean of 0.6 for preventive medications (p = 0.070), and 0.8 for acute medications (p = 0.050). The number of outpatient office-based visits also decreased [mean (SD): 6 months pre-index, 5.8 (4.4) vs. 6 months post-index, 4.1 (4.0); p < 0.0001].
The addition of fremanezumab preventively to gepants for acute migraine treatment was effective, resulted in fewer outpatient office visits, and yielded no SAEs or AEs that were novel to these migraine medication classes.
fremanezumab是一种靶向降钙素基因相关肽（CGRP）通路的单克隆抗体（mAb），小分子CGRP受体拮抗剂gepants均已获批用于治疗偏头痛或其症状。本研究评估了在使用gepants进行急性治疗的患者中添加fremanezumab进行偏头痛预防性治疗后的有效性、耐受性和偏头痛相关医疗资源利用（HCRU）情况。
在一项回顾性病历审查中，从牙科学院神经学研究所的电子病历中提取数据。符合条件的患者年龄≥18岁，正在使用gepants（rimegepant或ubrogepant），于2020年1月1日至2021年5月1日期间开始使用fremanezumab（索引日期：开始使用fremanezumab的日期），并持续同时使用gepants和fremanezumab≥1个月（索引后；随访7 - 9个月）。结局指标包括每月偏头痛天数（MMD）、不良事件（AE）、停药原因和偏头痛相关HCRU。
共有55例患者[女性，93%；平均（标准差）年龄，43.5（13.5）岁]符合纳入标准。所有患者均被诊断为慢性偏头痛。患者在索引日期时的平均（标准差）MMD为15.8（7.4）天。从索引日期到索引后的MMD平均（标准误）变化为 - 6.5（1.0）天（p < 0.0001）。5例患者（9.1%）在索引后出现AE；未报告严重不良事件（SAE）。从索引日期到索引后，预防性药物使用的偏头痛相关药物数量平均减少0.6（p = 0.070），急性药物减少0.8（p = 0.050）。门诊就诊次数也减少了[平均（标准差）：索引前6个月，5.8（4.4）次 vs. 索引后6个月，4.1（4.0）次；p < 0.0001]。
在用于急性偏头痛治疗的gepants基础上预防性添加fremanezumab是有效的，减少了门诊就诊次数，且未产生这些偏头痛药物类别中新增的SAE或AE。
