Department of Medicine, Montefiore Medical Center and the Albert Einstein College of Medicine, Bronx, New York.
Department of Neurology, Montefiore Medical Center and the Albert Einstein College of Medicine, Bronx, New York.
Pain Med. 2021 Aug 6;22(8):1857-1863. doi: 10.1093/pm/pnab093.
We examined the efficacy and tolerability of calcitonin gene-related peptide-targeted monoclonal antibodies (CGRP-targeted mAbs) as add-on therapy for patients with chronic migraine (CM) undergoing treatment with onabotulinumtoxinA (onabot) who require additional preventive therapy.
We reviewed medical records of patients with CM receiving treatment with onabot who were subsequently prescribed a CGRP-targeted mAb medication. The primary outcome was the change in number of monthly headache days (MHDs) reported. Secondary outcomes were change in headache pain severity, discontinuation due to lack of tolerability, and severe adverse events.
Of 153 patients, 111 (72.5%) reported a decrease in either MHDs or headache pain severity, with documentation of MHDs in 66 patients. Among these 66 patients, the average number of MHDs before initiation of onabot treatment was 25.7. After onabot treatment, an average decrease of 10.9 MHDs was reported (P < 0.001). After the addition of a CGRP-targeted mAb medication, patients experienced a further decrease of 5.7 MHDs (P < 0.001). With combined therapy, patients reported a total decrease of 16.6 MHDs (P < 0.001). Adverse effects occurred in 13 patients (8.5%) after addition of the CGRP-targeted mAb and included constipation, injection site reaction, and fatigue. No serious adverse events were reported.
Adding a CGRP-targeted mAb to onabot in patients with CM was associated with further reductions in MHDs without major tolerability issues across a range of mAbs. This retrospective review supports the conduct of a well-designed double-blind study adding a CGRP-targeted mAb or placebo to onabot.
我们研究了降钙素基因相关肽靶向单克隆抗体（CGRP 靶向 mAb）作为依那西普治疗慢性偏头痛（CM）患者的附加治疗的疗效和耐受性，这些患者正在接受依那西普治疗，需要额外的预防性治疗。
我们回顾了接受依那西普治疗的 CM 患者的病历，随后为这些患者开了 CGRP 靶向 mAb 药物。主要结局是报告的每月头痛天数（MHDs）的变化。次要结局是头痛疼痛严重程度的变化、因不耐受而停药以及严重不良事件。
在 153 名患者中，111 名（72.5%）报告 MHDs 或头痛疼痛严重程度降低，其中 66 名患者有 MHDs 记录。在这 66 名患者中，依那西普治疗前平均 MHDs 为 25.7。依那西普治疗后，报告平均 MHDs 减少 10.9（P<0.001）。添加 CGRP 靶向 mAb 药物后，患者的 MHDs 进一步减少了 5.7（P<0.001）。联合治疗后，患者报告 MHDs 总减少了 16.6（P<0.001）。添加 CGRP 靶向 mAb 后，13 名患者（8.5%）出现不良反应，包括便秘、注射部位反应和疲劳。没有报告严重的不良事件。
在 CM 患者中，将 CGRP 靶向 mAb 添加到依那西普中与进一步减少 MHDs 相关，同时在一系列 mAb 中没有出现主要的耐受性问题。这项回顾性研究支持进行一项精心设计的双盲研究，即在依那西普中添加 CGRP 靶向 mAb 或安慰剂。
