Risankizumab 在银屑病患者（中度至重度银屑病 [PsO] 和银屑病关节炎 [PsA]）中表现出良好的安全性。我们评估了 risankizumab 在银屑病疾病中的长期安全性。通过分析 20 项（1-4 期）斑块 PsO 临床试验和 4 项（2-3 期）PsA 临床试验的数据来评估长期安全性。在接受 ≥ 1剂量risankizumab的患者中报告了治疗中出现的不良事件（TEAE）和特别关注领域的AE。暴露调整事件率以每 100 患者年 (PY) 的事件 (E) 表示。长期安全性数据分析包括 3658 名 PsO 患者 (13,329.3 PY) 和 1542 名 PsA 患者 (3803.0 PY)。 PsO 和 PsA 患者的中位（范围）治疗持续时间分别为 4.1（0.2-8.8）年和 2.8（0.2-4.0）年。在 PsO 人群中，TEAE、严重 AE 和导致停药的 AE 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，这些比率分别为 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 E/100 PY 和 1.4 E/100 PY。两个人群的机会性感染（不包括结核病和带状疱疹）发生率均较低（< 0.1 E/100 PY）。 PsO 和 PsA 中非黑色素瘤皮肤癌 (NMSC) 和不包括 NMSC 的恶性肿瘤的发生率分别为 0.6 和 0.5 E/100 PY，均在既往流行病学研究的基准范围内。裁定的 PsO 重大心血管事件发生率为 0.5 E/100 PY，PsA 为 0.3 E/100 PY，均在这两种适应症的流行病学参考基准之内。这种长期暴露没有发现额外的安全性问题。结果支持 risankizumab 用于长期治疗银屑病疾病的良好安全性，没有新的安全性问题，并且 PsO 和 PsA 人群中的安全性相似。© 2024。作者。

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.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).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.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.© 2024. The Author(s).