Real-World Experience of Erenumab in Patients with Migraine in Germany: The SPECTRE Study.

IF 4.1 2区医学 Q1 CLINICAL NEUROLOGY Pain and Therapy Pub Date : 2024-12-01 Epub Date: 2024-10-21 DOI:10.1007/s40122-024-00658-7

Charly Gaul, Astrid Gendolla, Dagny Holle, Hartmut Göbel, Mirja Koch, Caroline Baufeld, Cordula Weiss

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Abstract

Introduction: To provide real-world insights into migraine patient population in Germany treated with erenumab, focusing on the prescription patterns and reasons for the initial dosage choice.

Methods: SPECTRE was an observational, non-interventional, multicenter, open-label, single-arm study in patients treated with erenumab according to approved local dose and guidelines. The study enrolled adult patients (n = 571; Germany: 105 sites) with migraine who had received erenumab for not more than 3 months before the start of the study.

Results: The mean (standard deviation) patient age was 45.0 (12.3) years, and most patients were female (89.0%), Caucasian (97.6%), and non-smokers (85.1%). The starting dose of erenumab was 70 mg in 68.5% of patients and 140 mg in 31.5%. The proportion of patients with 140 mg as the starting dose was the highest (43.5%) in those aged 30-40 years. The most common reason for starting a higher dose of erenumab 140 mg was severity of migraine (47.4%). During the observational period, the proportion of patients taking erenumab 140 mg increased to 64.6% (visit 5; V5) after 12 months. Due to attrition of patients towards the end of the study (V9: 90 participants), data at V9 must be interpreted with caution. At least one dose change was performed in 45.3% of patients (i.e., erenumab 70 to 140 mg or 140 to 70 mg), 21.2% of patients attempted at least once to discontinue treatment (i.e., period with erenumab discontinuation and no other antibody treatment for migraine prevention), and 15.3% discontinued erenumab treatment, mainly because of no or insufficient treatment response (13.5%). The mean time until the first omission attempt was 332.3 (range 37-633) days. Constipation (12.1%) was the most frequently reported adverse event, in line with the summary of product characteristics (SmPC) of erenumab.

Conclusion: Most patients with migraine were prescribed erenumab 70 mg as the starting dose. No new safety signals were observed for erenumab versus the previous trials.

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艾伦单抗在德国偏头痛患者中的实际应用经验：SPECTRE 研究。

内容简介目的：了解在德国接受艾伦单抗治疗的偏头痛患者的实际情况，重点关注处方模式和初始剂量选择的原因：SPECTRE是一项观察性、非干预性、多中心、开放标签、单臂研究，研究对象是根据当地批准的剂量和指南接受艾伦单抗治疗的患者。该研究招募了偏头痛成年患者（n = 571；德国：105个研究点），这些患者在研究开始前接受艾伦单抗治疗的时间不超过3个月：患者的平均年龄（标准差）为45.0（12.3）岁，大多数患者为女性（89.0%）、白种人（97.6%）和非吸烟者（85.1%）。68.5%的患者起始剂量为70毫克，31.5%的患者起始剂量为140毫克。起始剂量为 140 毫克的患者中，年龄在 30-40 岁之间的比例最高（43.5%）。开始服用较高剂量艾伦单抗140毫克的最常见原因是偏头痛严重（47.4%）。在观察期间，服用艾伦单抗140毫克的患者比例在12个月后增至64.6%（第5次就诊；V5）。由于患者在研究接近尾声时自然减员（V9：90 名参与者），因此必须谨慎解释 V9 的数据。45.3%的患者至少更换过一次剂量（即艾珠单抗从70毫克换到140毫克或从140毫克换到70毫克），21.2%的患者至少尝试过一次中断治疗（即停用艾珠单抗且未使用其他抗体治疗偏头痛），15.3%的患者中断了艾珠单抗治疗，主要原因是没有治疗反应或治疗反应不足（13.5%）。距首次尝试停药的平均时间为 332.3 天（37-633 天）。便秘（12.1%）是最常报告的不良事件，这与艾伦单抗的产品特性概要（SmPC）一致：结论：大多数偏头痛患者的起始剂量为艾伦单抗70毫克。与之前的试验相比，艾伦单抗未发现新的安全性信号。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

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来源期刊

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.