■描述开始galcanezumab与标准治疗(SOC)预防性偏头痛治疗(包括抗惊厥药)的患者的长期(24个月)治疗模式,β受体阻滞剂,抗抑郁药,和使用行政索赔数据的单克隆毒素A。
■这项回顾性队列研究,它使用了Optum去识别市场清晰度数据,纳入≥1例接受galcanezumab或SOC预防性偏头痛治疗的偏头痛患者(2018年9月1日-2020年3月31日),并在指标日期(基线)前12个月和(随访)后24个月(首次索赔日期)连续纳入数据库.基线患者人口统计,临床特征,24个月随访后分析治疗模式,包括依从性(以[PDC]覆盖天数的比例衡量),持久性,停药(≥60天间隔),重新启动,和治疗开关。倾向评分匹配(1:1)用于平衡galcanezumab和SOC队列。
■该研究包括2307对匹配的患者,并进行了24个月的随访。队列的平均年龄为44.5岁(女性:87%)。galcanezumab与SOC队列中的患者表现出更高的治疗依从性(PDC:48%与38%),更多的患者被认为是粘附的(PDC≥80%:26.6%vs.20.7%)和持久性(322.1vs.236.4天)(所有p<0.001)。经过24个月的随访,与接受SOC治疗的患者相比,接受galcanezumab治疗的患者停止治疗的患者较少(80.1%vs.84.7%;p<0.001),其中41.3%和39.6%改用非指标药物,分别。在这两个队列中,最普遍的患者改用的药物是erenumab。与SOC药物相比,开始使用galcanezumab的患者比例明显更高,改用了fremanezumab(p<0.001)和onabotulinumtoxinA(p=0.016)。
在24个月随访后,与开始使用SOC药物的患者相比,开始使用galcanezumab预防偏头痛的患者具有更高的治疗依从性和持久性。
只有少数患者(3-13%)患有偏头痛,有资格接受预防性治疗的人,正在使用它们。传统的预防性治疗方法尚未专门针对偏头痛的治疗而开发。超过一半的患者过早停止使用它们。降钙素基因相关肽单克隆抗体,如galcanezumab,fremanezumab,和erenumab是提供偏头痛特异性预防性治疗的较新的治疗方法.先前的研究比较了开始使用galcanezumab的患者与开始使用传统标准治疗(SOC)偏头痛预防药物的患者的6至12个月偏头痛药物。我们比较了开始使用galcanezumab的患者与开始使用SOC偏头痛预防药物的患者的长期(24个月)偏头痛药物,以确认结果是否持续更长的时间。超过24个月,与使用SOC药物的患者相比,使用galcanezumab的患者在更大程度上遵循了规定的治疗方案(48%vs.38%,分别)。此外,与使用SOC的患者相比,使用galcanezumab的患者持续治疗时间更长.超过24个月,大约85%的患者停止服用SOC药物,而约80%的患者停止服用galcanezumab.我们的发现表明,与SOC药物相比,偏头痛患者更有可能继续使用galcanezumab作为预防性治疗更长的时间。这项研究有助于确定偏头痛预防性治疗中的差距,并提供有关它们如何使用不足的见解。
To describe long-term (24-month) treatment patterns of patients initiating galcanezumab versus standard of care (SOC) preventive migraine treatments including anticonvulsants, beta-blockers, antidepressants, and onabotulinumtoxinA using administrative claims data.
This retrospective cohort
study, which used Optum de-identified Market Clarity data, included adults with migraine with ≥1 claim for galcanezumab or SOC preventive migraine therapy (September 1, 2018 - March 31, 2020) and continuous database enrollment for 12 months before (baseline) and 24 months after (follow-up) the index date (date of first claim). Baseline patient demographics, clinical characteristics, and treatment patterns were analyzed after 24-month follow-up, including adherence (measured as the proportion of days covered [PDC]), persistence, discontinuation (≥60-day gap), restart, and treatment
switch. Propensity score matching (1:1) was used to balance the galcanezumab and SOC cohorts.
The
study included 2307 matched patient pairs with 24-month follow-up. The mean age across cohorts was 44.5 years (females: ∼87%). Patients in the galcanezumab versus SOC cohort demonstrated greater treatment adherence (PDC: 48% vs. 38%), with more patients considered adherent (PDC ≥80%: 26.6% vs. 20.7%) and persistent (322.1 vs. 236.4 d) (all p < .001). After 24-month follow-up, fewer galcanezumab-treated patients had discontinued compared with SOC-treated patients (80.1% vs. 84.7%; p < .001), of which 41.3% and 39.6% switched to a non-index medication, respectively. The most prevalent medication patients switched to in both cohorts was erenumab. Significantly greater proportions of patients who initiated galcanezumab versus SOC medications switched to fremanezumab (p < .001) and onabotulinumtoxinA (p = .016).
Patients who initiated galcanezumab for migraine prevention had higher treatment adherence and persistence compared with those who initiated SOC medications after 24-month follow-up.
Only few patients (3 − 13%) with migraine, who qualify for preventive treatment, are using them. Conventional preventive treatments have not been developed specifically for migraine treatment, and more than half of the patients stop using them prematurely. Calcitonin gene-related peptide monoclonal antibodies such as galcanezumab, fremanezumab, and erenumab are newer treatments that provide migraine-specific preventive treatment. Prior studies have compared 6- to 12-month migraine medication use by patients starting galcanezumab versus those starting traditional standard of care (SOC) migraine preventive medications. We compared long-term (24-month) migraine medication use in patients starting galcanezumab versus those starting SOC migraine preventive medications to confirm if the results are sustained over a longer period. Over 24 months, patients who used galcanezumab followed the prescribed treatment regimen to a greater extent compared with those who used SOC medications (48% vs. 38%, respectively). Additionally, patients using galcanezumab continued treatment for a longer time compared with those using SOC. Over 24 months, about 85% of patients stopped taking SOC medications, while around 80% of patients stopped taking galcanezumab. Our findings indicate that patients with migraine are more likely to continue using galcanezumab as a preventive treatment for a longer period compared with SOC medications. This
study helps identify gaps in the preventive treatment of migraine and provides insights on how they are not being used enough.