Brodalumab: Six-Year US Pharmacovigilance Report.

IF 3.5 3区医学 Q1 DERMATOLOGY Dermatology and Therapy Pub Date : 2024-11-26 DOI:10.1007/s13555-024-01304-y

Mark G Lebwohl, John Y Koo, April W Armstrong, Bruce E Strober, Soo Han Yoon, Nicole N Rawnsley, Earl L Goehring, Gina D Mangin, Abby A Jacobson

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Abstract

Introduction: Brodalumab is a human interleukin-17 receptor A antagonist indicated for the treatment of moderate-to-severe plaque psoriasis in adult patients who are candidates for systemic therapy or phototherapy and have failed to respond or have lost response to other systemic therapies. In the USA, brodalumab has a boxed warning regarding suicidal ideation and behavior and is only available under a Risk Evaluation and Mitigation Strategy, but no causal association has been established. To assess long-term safety of brodalumab, we summarize pharmacovigilance data from 6 years of real-world clinical practice.

Methods: Crude adverse event (AE) reporting rates per 100 patients were calculated for common AEs and AEs of special interest reported to Ortho Dermatologics by US patients and healthcare providers from August 15, 2017 through August 14, 2023. Brodalumab exposure was estimated as time from the first to last prescription-dispensing authorization dates. Adverse events were defined by Medical Dictionary for Regulatory Activities v26.0 Preferred Terms and standardized MedDRA queries.

Results: Data were collected from 5138 US patients (estimated exposure of 6900 patient-years). Over 6 years, 13 cases of adjudicated major adverse cardiovascular events were reported (0.25 events/100 patients). The rate of serious infections was 2.20 events/100 patients. Since the 5-year report, there was one new case of Candida infection and a serious fungal infection of the elbow. Among 57 reported malignancies affecting 49 patients, 4 were deemed possibly related to brodalumab. One new case of indeterminate inflammatory bowel disease unrelated to brodalumab was reported. No new suicide attempts were reported in year 6, and there were no completed suicides throughout 6 years.

Conclusion: Pharmacovigilance data throughout 6 years are consistent with the safety profile of brodalumab established in clinical trials and previous US pharmacovigilance reports, with no completed suicides and a low fungal infection rate.

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Brodalumab：美国药物警戒六年报告。

简介布达鲁单抗是一种人白细胞介素-17受体A拮抗剂，适用于治疗成年患者的中重度斑块状银屑病，这些患者可接受系统疗法或光疗，但对其他系统疗法无效或失去反应。在美国，brodalumab 有关于自杀意念和行为的盒装警告，并且只能在风险评估和缓解策略下使用，但尚未建立因果关系。为了评估brodalumab的长期安全性，我们总结了6年实际临床实践中的药物警戒数据：计算了自 2017 年 8 月 15 日至 2023 年 8 月 14 日期间，美国患者和医疗保健提供者向 Ortho Dermatologics 报告的常见 AE 和特别关注 AE 的每 100 例患者粗不良事件 (AE) 报告率。布达鲁单抗的暴露时间按首次处方配药授权日期到最后一次处方配药授权日期的时间估算。不良事件根据《监管活动医学词典》v26.0版首选术语和标准化MedDRA查询进行定义：从 5138 名美国患者中收集了数据（估计暴露于 6900 患者年）。6 年间，共报告了 13 例裁定的重大心血管不良事件（0.25 例/100 名患者）。严重感染率为 2.20 例/100 名患者。自 5 年报告以来，新增了一例念珠菌感染和一例严重的肘部真菌感染。在 49 名患者的 57 例恶性肿瘤报告中，有 4 例被认为可能与博达单抗有关。新报告了一例与brodalumab无关的不确定炎症性肠病。第6年没有报告新的自杀企图，6年中也没有发生自杀事件：结论：6年来的药物警戒数据与临床试验和之前的美国药物警戒报告中确定的brodalumab安全性特征一致，没有发生自杀事件，真菌感染率较低。

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

Dermatology and Therapy Medicine-Dermatology

CiteScore

6.00

自引率

8.80%

发文量

187

审稿时长

6 weeks

期刊介绍： Dermatology and Therapy is an international, open access, peer-reviewed, rapid publication journal (peer review in 2 weeks, published 3–4 weeks from acceptance). The journal is dedicated to the publication of high-quality clinical (all phases), observational, real-world, and health outcomes research around the discovery, development, and use of dermatological therapies. Studies relating to diagnosis, pharmacoeconomics, public health and epidemiology, quality of life, and patient care, management, and education are also encouraged. Areas of focus include, but are not limited to all clinical aspects of dermatology, such as skin pharmacology; skin development and aging; prevention, diagnosis, and management of skin disorders and melanomas; research into dermal structures and pathology; and all areas of aesthetic dermatology, including skin maintenance, dermatological surgery, and lasers. The journal is of interest to a broad audience of pharmaceutical and healthcare professionals and publishes original research, reviews, case reports/case series, trial protocols, and short communications. Dermatology 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 quality research, which may be considered of insufficient interest by other journals. The journal appeals to a global audience and receives submissions from all over the world.