Varnado Oralee J, Manjelievskaia Janna, Ye Wenyu, Perry Allison, Schuh Kory, Wenzel Richard
Value, Evidence, and Outcomes, Eli Lilly and Company, Indianapolis, IN, USA.
Watson Health Life Sciences, Research & Analytics, IBM Watson Health, Cambridge, MA, USA.
Patient Prefer Adherence. 2022 Mar 29;16:821-839. doi: 10.2147/PPA.S346660. eCollection 2022.
Most conventional, oral, preventive treatments for migraine are non-specific and ~50% of patients discontinue them within six months. In 2018, the Food and Drug Administration approved three preventive migraine treatments: monoclonal antibodies (mAb) targeting the calcitonin gene-related peptide (CGRP) pathway implicated in migraine; galcanezumab and fremanezumab which target CGRP ligand; and erenumab which targets CGRP receptor. Real-world treatment patterns for CGRP mAb are limited.
To compare real-world treatment patterns for CGRP mAb, specifically galcanezumab versus standard-of-care (SOC) migraine preventive treatments.
This retrospective, observational study included 12-month baseline and 6- and 12-month follow-up analyses using IBM MarketScan databases. Patients identified were aged ≥18 years with ≥1 claim (first claim=index) for CGRP mAb (erenumab, fremanezumab, or galcanezumab) or SOC preventives (eg, antiepileptics, beta-blockers, antidepressants, or onabotulinumtoxinA) as index drugs between May/01/2018 and June/30/2019. Propensity score matching was used to address confounding by observed covariates. Outcomes analyzed included proportion of days covered (PDC), persistence (≤60-day gap), and first non-index drug switch. Descriptive, chi-square (categorical), and -test (continuous) analyses were conducted.
The study included 3082 (CGRP mAb versus SOC) and 421 (galcanezumab versus SOC) matched patient pairs with 12-month follow-up. Mean age across cohorts ranged 43.2-44.4 years (females: 85.7-88.6%). Compared with SOC, the CGRP mAb cohort had higher mean persistence (212.5 vs 131.9 days), adherence (PDC: 55.1% vs 35.2%), and more patients were adherent with PDC ≥80% (32.7% vs 18.7%) (all p <0.001). During 12-month follow-up, fewer patients discontinued CGRP mAb versus SOC (58.8% vs 77.6%, p <0.001). Galcanezumab versus SOC comparisons yielded similar results. In the CGRP mAb cohort, most switchers (28.3%) used galcanezumab as subsequent treatment. Largely similar results were observed for 6-month follow-up cohorts.
Patients on CGRP mAb and specifically galcanezumab showed higher adherence and persistence than patients on SOC migraine preventive treatments.
大多数传统的口服偏头痛预防性治疗方法都不具有特异性，约50%的患者在六个月内停止使用这些药物。2018年，美国食品药品监督管理局批准了三种偏头痛预防性治疗药物：靶向与偏头痛相关的降钙素基因相关肽（CGRP）通路的单克隆抗体（mAb）；靶向CGRP配体的加卡尼单抗和夫雷西单抗；以及靶向CGRP受体的erenumab。CGRP单克隆抗体在现实世界中的治疗模式有限。
比较CGRP单克隆抗体，特别是加卡尼单抗与偏头痛预防性治疗的标准治疗（SOC）方法在现实世界中的治疗模式。
这项回顾性观察性研究使用IBM MarketScan数据库进行了12个月的基线分析以及6个月和12个月的随访分析。确定的患者年龄≥18岁，在2018年5月1日至2019年6月30日期间，至少有1次CGRP单克隆抗体（erenumab、夫雷西单抗或加卡尼单抗）或SOC预防性药物（如抗癫痫药、β受体阻滞剂、抗抑郁药或A型肉毒毒素）作为索引药物的报销记录（首次报销记录=索引）。倾向评分匹配用于处理观察到的协变量造成的混杂。分析的结果包括覆盖天数比例（PDC）、持续性（间隔≤60天）和首次非索引药物转换。进行了描述性、卡方（分类）和t检验（连续）分析。
该研究纳入了3082对（CGRP单克隆抗体与SOC）和421对（加卡尼单抗与SOC）匹配的患者对，并进行了12个月的随访。各队列的平均年龄在43.2至44.4岁之间（女性：85.7 - 88.6%）。与SOC相比，CGRP单克隆抗体队列的平均持续性更高（212.5天对131.9天）、依从性更好（PDC：55.1%对35.2%），且更多患者的PDC≥80%（32.7%对18.7%）（所有p<0.001）。在12个月的随访期间，与SOC相比，停止使用CGRP单克隆抗体的患者更少（58.8%对77.6%，p<0.001）。加卡尼单抗与SOC的比较产生了类似的结果。在CGRP单克隆抗体队列中，大多数换药者（28.3%）随后使用加卡尼单抗进行治疗。6个月随访队列观察到的结果基本相似。
使用CGRP单克隆抗体特别是加卡尼单抗的患者比使用SOC偏头痛预防性治疗的患者表现出更高的依从性和持续性。
