Department of Neurology, Albert Einstein College of Medicine, Bronx, NY, USA.
Global Medical Affairs, Teva Branded Pharmaceutical Products R&D, Inc., West Chester, PA, USA.
Headache. 2021 Apr;61(4):662-672. doi: 10.1111/head.14097.
To evaluate the efficacy of fremanezumab in patients with chronic migraine (CM) and moderate to severe depression.
Fremanezumab, a fully humanized monoclonal antibody that selectively targets calcitonin gene-related peptide, has been approved for the preventive treatment of migraine in adults. CM and depression are highly comorbid.
The 12-week, Phase 3 HALO trial randomized patients with CM to fremanezumab quarterly (675 mg/placebo/placebo), fremanezumab monthly (675/225/225 mg), or placebo. Post hoc analyses evaluated the effects of fremanezumab in patients with moderate to severe depression (baseline 9-item Patient Health Questionnaire sum score ≥10) on monthly number of headache days of at least moderate severity; monthly migraine days; Patient Global Impression of Change (PGIC); 6-item Headache Impact Test (HIT-6) scores; and depression.
For the 219/1121 (19.5%) patients with moderate to severe depression at baseline, fremanezumab was associated with a significant reduction in monthly number of headache days of at least moderate severity for active treatment versus placebo (least-squares mean change ± standard error for quarterly dosing: -5.3 ± 0.77; for monthly dosing: -5.5 ± 0.72; and for placebo: -2.2 ± 0.81; both p < 0.001). More patients achieved a ≥50% reduction in headache days of at least moderate severity with fremanezumab (quarterly: 31/78 [39.7%]; monthly: 39/96 [40.6%]) than placebo (9/67 [13.4%]; both p < 0.001). Compared with placebo, fremanezumab improved PGIC and HIT-6 scores.
Fremanezumab demonstrated efficacy in the preventive treatment of CM and reduced headache impact in patients with comorbid depression.
评估依洛尤单抗治疗慢性偏头痛（CM）伴中重度抑郁患者的疗效。
依洛尤单抗是一种完全人源化的单克隆抗体，可选择性靶向降钙素基因相关肽，已被批准用于成人偏头痛的预防性治疗。CM 与抑郁高度共病。
为期 12 周的 3 期 HALO 试验将 CM 患者随机分为依洛尤单抗每季度（675mg/安慰剂/安慰剂）、依洛尤单抗每月（675/225/225mg）或安慰剂组。事后分析评估了依洛尤单抗对基线时存在中重度抑郁（基线 9 项患者健康问卷总分≥10）患者每月至少中度严重头痛天数、每月偏头痛天数、患者总体变化印象（PGIC）、6 项头痛影响测试（HIT-6）评分和抑郁的影响。
对于基线时有中重度抑郁的 219/1121（19.5%）例患者，与安慰剂相比，依洛尤单抗治疗可显著减少每月至少中度严重头痛天数（依洛尤单抗每季度给药的最小二乘均数变化±标准误差：-5.3±0.77；每月给药：-5.5±0.72；安慰剂：-2.2±0.81；均 p<0.001）。与安慰剂相比，更多患者接受依洛尤单抗治疗后头痛天数至少中度严重程度减少≥50%（依洛尤单抗：31/78[39.7%]；每月：39/96[40.6%]），而安慰剂为 9/67[13.4%]；均 p<0.001）。与安慰剂相比，依洛尤单抗改善了 PGIC 和 HIT-6 评分。
依洛尤单抗在 CM 的预防性治疗中有效，并减轻了伴发抑郁患者的头痛影响。
