Observational Retrospective Study in Patients Treated with Galcanezumab as Preventive Treatment for Migraine: The ORYGAM Study

IF 4.1 2区 医学 Q1 CLINICAL NEUROLOGY
Samuel Díaz Insa, Ángel Guerrero, Javier Viguera, Vicente Medrano Martínez, Carlos Calle de Miguel, Jesús Porta-Etessam, Antonio Ciudad, Silvia Diaz-Cerezo, Ana Roncero Martín, Mercedes Núñez
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引用次数: 0

Abstract

Introduction

The efficacy of galcanezumab has been demonstrated in randomized controlled trials, but evidence about its use under clinical practice conditions is still limited. This study aimed to describe the characteristics of the patients treated with galcanezumab in routine clinical practice in Spain as well as treatment patterns, persistence, and effectiveness.

Methods

A retrospective chart review study was carried out in six hospitals. Information of adults with migraine, who started treatment with galcanezumab between November 2019 and September 2021, was analyzed until end or loss of follow-up. Continuous variables were described as mean (standard deviation, SD) and median (interquartile range, IQR), and categorical variables as frequency and percentages. Persistence to treatment was estimated using Kaplan–Meier analysis.

Results

A total of 314 patients were analyzed over median follow-up period of 17.5 months (13.8–20.7), with a mean age of 46.3 (12.6), 85% women, 80.6% chronic migraine, and reporting a mean of monthly migraine days of 16.7 (7.8). Overall, 72.9% had comorbid conditions, with anxiety and depression disorders being the most frequent. More than 60% had received ≥ 6 previous preventive drugs, the most common being antiepileptics, antidepressants, and botulinum toxin (95.2%, 89.8% and 84.1%, respectively). Overall, 60.3% of the patients with other preventive treatments maintained them after galcanezumab initiation. The median time on galcanezumab was 14.6 months (9.4–22.8); 95.7%, 82.0%, 76.2% and 59.8% of patients were persistent to treatment at 3, 6, 9 and 12 months, respectively. Of the patients who discontinued (151: 48.1%), 57.6% were due to lack of effectiveness and 31.1% were due to improvement in migraine. The average reduction of monthly migraine days at 3, 6, 9 and 12 months was 7.9 (7.2), 9.1 (7.5), 8.8 (6.6) and 9.0 (6.9) days, respectively.

Conclusions

In real clinical practice, galcanezumab is an effective treatment and has a high persistence in patients with migraine, mostly chronic and with multiple use of previous preventive treatments.

Abstract Image

用加坎珠单抗预防性治疗偏头痛患者的观察性回顾研究:ORYGAM 研究
导言:加坎珠单抗的疗效已在随机对照试验中得到证实,但在临床实践中使用的证据仍然有限。本研究旨在描述在西班牙常规临床实践中接受加卡尼珠单抗治疗的患者的特征,以及治疗模式、持续性和有效性。研究分析了2019年11月至2021年9月期间开始接受加卡尼珠单抗治疗的成人偏头痛患者的信息,直至随访结束或失去随访。连续变量以均数(标准差,SD)和中位数(四分位距,IQR)表示,分类变量以频率和百分比表示。中位随访时间为 17.5 个月(13.8-20.7 个月),平均年龄为 46.3 岁(12.6 岁),85% 为女性,80.6% 为慢性偏头痛患者,平均每月偏头痛天数为 16.7 天(7.8 天)。总体而言,72.9%的患者有合并症,其中以焦虑症和抑郁症最为常见。60%以上的患者曾服用过≥6种预防药物,其中最常见的是抗癫痫药、抗抑郁药和肉毒毒素(分别为95.2%、89.8%和84.1%)。总体而言,60.3%的患者在开始使用 galcanezumab 后仍在接受其他预防治疗。使用加卡尼珠单抗的中位时间为14.6个月(9.4-22.8个月);分别有95.7%、82.0%、76.2%和59.8%的患者在3个月、6个月、9个月和12个月后仍坚持治疗。在中断治疗的患者中(151人,占48.1%),57.6%是因为疗效不佳,31.1%是因为偏头痛有所改善。结论在实际临床实践中,加卡尼珠单抗是一种有效的治疗方法,对偏头痛患者(多为慢性偏头痛患者,且曾多次使用预防性治疗方法)具有很高的持续性。
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来源期刊
Pain and Therapy
Pain and Therapy CLINICAL NEUROLOGY-
CiteScore
6.60
自引率
5.00%
发文量
110
审稿时长
6 weeks
期刊介绍: Pain and Therapy is an international, open access, peer-reviewed, rapid publication journal dedicated to the publication of high-quality clinical (all phases), observational, real-world, and health outcomes research around the discovery, development, and use of pain therapies and pain-related devices. Studies relating to diagnosis, pharmacoeconomics, public health, quality of life, and patient care, management, and education are also encouraged. Areas of focus include, but are not limited to, acute pain, cancer pain, chronic pain, headache and migraine, neuropathic pain, opioids, palliative care and pain ethics, peri- and post-operative pain as well as rheumatic pain and fibromyalgia. The journal is of interest to a broad audience of pharmaceutical and healthcare professionals and publishes original research, reviews, case reports, trial protocols, short communications such as commentaries and editorials, and letters. The journal is read by a global audience and receives submissions from around the world. Pain and Therapy will consider all scientifically sound research be it positive, confirmatory or negative data. Submissions are welcomed whether they relate to an international and/or a country-specific audience, something that is crucially important when researchers are trying to target more specific patient populations. This inclusive approach allows the journal to assist in the dissemination of all scientifically and ethically sound research.
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