Long-Term Safety of Risankizumab in Patients with Psoriatic Disease: A Comprehensive Analysis from Clinical Trials.

IF 3.5 3区医学 Q1 DERMATOLOGY Dermatology and Therapy Pub Date : 2024-09-01 Epub Date: 2024-08-17 DOI:10.1007/s13555-024-01238-5

Kenneth B Gordon, Andrew Blauvelt, Hervé Bachelez, Laura C Coates, Filip E Van den Bosch, Blair Kaplan, Willem Koetse, Doug G Ashley, Ralph Lippe, Ranjeeta Sinvhal, Kim A Papp

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Abstract

Introduction: Risankizumab has demonstrated a favourable safety profile in patients with psoriatic disease (moderate-to-severe psoriasis [PsO] and psoriatic arthritis [PsA]). We evaluated the long-term safety of risankizumab in psoriatic disease.

Methods: Long-term safety was evaluated by analysing data from 20 (phase 1-4) clinical trials for plaque PsO and four (phase 2-3) trials for PsA. Treatment-emergent adverse events (TEAEs) and AEs in areas of special interest were reported among patients receiving ≥ 1 dose of risankizumab. Exposure-adjusted event rates were presented as events (E) per 100 patient-years (PY).

Results: The long-term safety data analyses included 3658 patients with PsO (13,329.3 PY) and 1542 patients with PsA (3803.0 PY). The median (range) treatment duration for patients with PsO and PsA was 4.1 (0.2-8.8) years and 2.8 (0.2-4.0) years, respectively. In the PsO population, rates of TEAEs, serious AEs and AEs leading to discontinuation were 145.5 E/100 PY, 7.4 E/100 PY and 1.9 E/100 PY, respectively; in the PsA population, these rates were 142.6 E/100 PY, 8.6 E/100 PY, and 1.8 E/100 PY, respectively. The rates of serious infections (excluding COVID-19-related infections) in the PsO and PsA populations were 1.2 and 1.4 E/100 PY, respectively. The rates of opportunistic infections (excluding tuberculosis and herpes zoster) were low (< 0.1 E/100 PY) in both populations. The rates of both nonmelanoma skin cancer (NMSC) and malignant tumours excluding NMSC were 0.6 and 0.5 E/100 PY in PsO and PsA, respectively, which are within the benchmarks of prior epidemiological studies. Adjudicated major cardiovascular event rates were 0.5 E/100 PY in PsO and 0.3 E/100 PY in PsA, which are within the epidemiologic reference benchmarks for both indications. No additional safety concerns were identified with this long-term exposure.

Conclusions: The results support the favourable safety profile of risankizumab for long-term treatment of psoriatic disease with no new safety concerns and similar safety profiles among both PsO and PsA populations.

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利桑珠单抗对银屑病患者的长期安全性：临床试验综合分析

简介：利桑珠单抗在银屑病（中重度银屑病[PsO]和银屑病关节炎[PsA]）患者中具有良好的安全性。我们评估了利桑珠单抗治疗银屑病的长期安全性：通过分析 20 项斑块型银屑病临床试验（1-4 期）和 4 项 PsA 临床试验（2-3 期）的数据，对长期安全性进行了评估。在接受≥1次利桑珠单抗治疗的患者中报告了治疗突发不良事件（TEAEs）和特别关注领域的AEs。暴露调整后的事件发生率以每100患者年（PY）的事件数（E）表示：长期安全性数据分析包括3658例PsO患者（13329.3年）和1542例PsA患者（3803.0年）。PsO和PsA患者的治疗时间中位数（范围）分别为4.1（0.2-8.8）年和2.8（0.2-4.0）年。在PsO人群中，TEAEs、严重AEs和导致停药的AEs发生率分别为145.5 E/100 PY、7.4 E/100 PY和1.9 E/100 PY；在PsA人群中，这些发生率分别为142.6 E/100 PY、8.6 E/100 PY和1.8 E/100 PY。PsO和PsA人群的严重感染率（不包括COVID-19相关感染）分别为1.2和1.4 E/100PY。机会性感染（不包括肺结核和带状疱疹）的发生率较低（结论：COVID-19 的安全性较高：结果支持利桑珠单抗用于银屑病长期治疗的良好安全性，没有新的安全性问题，PsO 和 PsA 患者的安全性相似。

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.