Lebwohl Mark G, Koo John Y, Armstrong April W, Strober Bruce E, Yoon Soo Han, Rawnsley Nicole N, Goehring Earl L, Mangin Gina D, Jacobson Abby A
Icahn School of Medicine at Mount Sinai, 5 East 98th Street, 5th Floor, New York, NY, 10029, USA.
Psoriasis and Skin Treatment Center, University of California, San Francisco, San Francisco, CA, USA.
Dermatol Ther (Heidelb). 2025 Jan;15(1):213-222. doi: 10.1007/s13555-024-01304-y. Epub 2024 Nov 26.
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.
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.
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.
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.
布罗达单抗是一种人白细胞介素-17受体A拮抗剂，适用于治疗适合全身治疗或光疗且对其他全身治疗无反应或已失去反应的成年中重度斑块状银屑病患者。在美国，布罗达单抗有关于自杀意念和行为的黑框警告，且仅在风险评估与降低策略下才可获得，但尚未确立因果关系。为评估布罗达单抗的长期安全性，我们总结了6年真实世界临床实践中的药物警戒数据。
计算了2017年8月15日至2023年8月14日期间美国患者和医疗服务提供者向奥多皮肤科报告的常见不良事件（AE）和特殊关注AE每100例患者的原始报告率。布罗达单抗暴露量估计为从首次到最后一次处方配药授权日期的时间。不良事件由《药物监管活动医学词典》第26.0版首选术语和标准化MedDRA查询定义。
收集了5138例美国患者的数据（估计暴露量为6900患者年）。6年期间，报告了13例经判定的主要不良心血管事件（0.25事件/100例患者）。严重感染率为2.20事件/100例患者。自5年报告以来，有1例新的念珠菌感染病例和1例肘部严重真菌感染病例。在报告的影响49例患者的57例恶性肿瘤中，4例被认为可能与布罗达单抗有关。报告了1例与布罗达单抗无关的新的不明炎症性肠病病例。第6年未报告新的自杀未遂事件，6年期间无自杀死亡病例。
6年的药物警戒数据与临床试验和美国先前药物警戒报告中确立的布罗达单抗安全性概况一致，无自杀死亡病例且真菌感染率低。
