生物制剂的获益/风险状况可能会受到合并症、某些人口特征和合并用药的影响；因此，评估生物制剂在广大患者群体中的长期安全性非常重要。在针对中重度银屑病和/或活动性银屑病关节炎 (PsA) 成人的各项关键临床研究中，古塞奇尤单抗具有良好的耐受性和有效性。当前分析的目的是评估古塞奇尤单抗在大量银屑病患者中的安全性通过汇集来自 11 项 II/III 期研究的不良事件 (AE) 数据（7 项针对银屑病；4 项针对银屑病关节炎）。古塞奇尤单抗通常在第 0 周、第 4 周进行皮下注射，然后每 8 周 (Q8W) 进行一次皮下注射研究中，以及 PsA 研究中的第 0 周、第 4 周，然后每 4 周（第 4 周）或第 8 周进行一次。总结了安慰剂对照期（银屑病第 0-16 周；银屑病关节炎第 0-24 周）和报告期结束时（银屑病最长 5 年；银屑病关节炎最长 2 年）的安全性数据。使用综合数据，事后确定关键 AE 的发生率，根据随访持续时间进行调整，并每 100 患者年 (PY) 进行报告。 AE 发生率还根据性别、年龄、体重指数 (BMI) 和既往生物制剂使用情况定义的患者亚组进行确定。在安慰剂对照期间，1061 名患者接受安慰剂（395 PY），2257 名患者接受古塞奇尤单抗（856 PY）。 。截至报告期末，4399 名接受古塞奇尤单抗治疗的患者贡献了 10,787 PY 的随访。在安慰剂对照期间，古塞奇尤单抗组和安慰剂组的 AE 发生率分别为 281 例和 272/100 PY，感染率分别为 76.0 例和 72.2/100 PY。严重 AE 发生率（5.6 例 vs. 7.8/100 PY）、导致停药的 AE（4.9 vs. 6.6/100 PY）、严重感染（1.0 vs. 2.3/100 PY）、恶性肿瘤（0.59 vs. 0.25 名患者/100 PY）的发生率）和主要不良心血管事件（MACE；0.35 与 0.25/100 PY）较低，古塞奇尤单抗和安慰剂之间具有可比性。在接受古塞奇尤单抗治疗的患者中，截至报告期结束时的安全事件发生率在数字上低于或与安慰剂对照期间观察到的发生率相当：AE，164/100 PY；感染，61.2/100 PY；严重 AE，5.4/100 PY；导致停药的 AE，1.8/100 PY；严重感染，1.0/100 PYs；恶性肿瘤，0.6/100 PY；和 MACE，0.3/100 PY。在接受古塞奇尤单抗治疗的患者中，没有报告克罗恩病、溃疡性结肠炎或活动性结核病的不良事件。在银屑病研究中，接受古塞奇尤单抗治疗的患者中未报告机会性感染。在接受 guselkumab 治疗的 PsA 患者中报告了 3 项机会性感染的 AE（0.14/100 PY；全部在 DISCOVER-2 中第 52 周后）。根据性别、年龄、BMI 和既往生物制剂使用情况定义的接受古塞奇尤单抗治疗的患者亚组的 AE 发生率基本一致。 在对 4399 名接受古塞奇尤单抗治疗的银屑病患者进行的为期 10,787 个 PY 的分析中，古塞奇尤单抗具有良好的 AE 特征。古塞奇尤单抗和安慰剂治疗的患者之间的 AE 发生率相似，并且在长期古塞奇尤单抗治疗期间以及银屑病患者的广泛亚组中保持一致。Clinicaltrials.gov 标识符：NCT01483599、NCT02207231、NCT02207244、NCT02203032、NCT02905331、NCT03090100、NCT 02325219, NCT02319759、NCT03162796、NCT03158285 和 NCT03796858。© 2023。作者。

The benefit/risk profiles of biologics can be affected by comorbidities, certain demographic characteristics, and concomitant medications; therefore, it is important to evaluate the long-term safety profiles of biologics across broad patient populations. Guselkumab was well tolerated and efficacious across individual pivotal clinical studies in adults with moderate-to-severe psoriasis and/or active psoriatic arthritis (PsA).The objective of the current analysis was to evaluate guselkumab safety in a large population of patients with psoriatic disease by pooling adverse event (AE) data from 11 phase II/III studies (seven in psoriasis; four in PsA).Guselkumab was generally administered as 100 mg subcutaneous injections at Week 0, Week 4, then every 8 weeks (Q8W) in psoriasis studies and at Week 0, Week 4, then every 4 weeks (Q4W) or Q8W in PsA studies. Safety data were summarized for the placebo-controlled period (Weeks 0-16 in psoriasis; Weeks 0-24 in PsA) and through the end of the reporting period (up to 5 years in psoriasis; up to 2 years in PsA). Using the integrated data, incidence rates of key AEs were determined post hoc, adjusted for duration of follow-up, and reported per 100 patient-years (PYs). AE rates were also determined in subgroups of patients defined by sex, age, body mass index (BMI), and prior biologic use.During the placebo-controlled period, 1061 patients received placebo (395 PYs) and 2257 received guselkumab (856 PYs). Through the end of the reporting period, 4399 guselkumab-treated patients contributed 10,787 PYs of follow-up. During the placebo-controlled period, in the guselkumab and placebo groups, respectively, rates of AEs were 281 versus 272/100 PYs, and infections were 76.0 versus 72.2/100 PYs. Rates of serious AEs (5.6 vs. 7.8/100 PYs), AEs leading to discontinuation (4.9 vs. 6.6/100 PYs), serious infections (1.0 vs. 2.3/100 PYs), malignancy (0.59 vs. 0.25 patients/100 PYs), and major adverse cardiovascular events (MACE; 0.35 vs. 0.25/100 PYs) were low and comparable between guselkumab and placebo. Among guselkumab-treated patients, safety event rates through the end of the reporting period were numerically lower than or comparable with rates observed during the placebo-controlled period: AEs, 164/100 PYs; infections, 61.2/100 PYs; serious AEs, 5.4/100 PYs; AEs leading to discontinuation, 1.8/100 PYs; serious infections, 1.0/100 PYs; malignancy, 0.6/100 PYs; and MACE, 0.3/100 PYs. No AEs of Crohn's disease, ulcerative colitis, or active tuberculosis were reported among guselkumab-treated patients. In the psoriasis studies, no opportunistic infections were reported among guselkumab-treated patients. Three AEs of opportunistic infections were reported in guselkumab-treated patients with PsA (0.14/100 PYs; all after Week 52 in DISCOVER-2). AE rates were largely consistent across subgroups of guselkumab-treated patients defined by sex, age, BMI, and prior biologic use.In this analysis of 4399 guselkumab-treated patients with psoriatic disease followed for 10,787 PYs, guselkumab had a favorable AE profile. AE rates were similar between guselkumab- and placebo-treated patients and were consistent throughout long-term guselkumab treatment and across broad subgroups of patients with psoriatic disease.Clinicaltrials.gov identifiers: NCT01483599, NCT02207231, NCT02207244, NCT02203032, NCT02905331, NCT03090100, NCT02325219, NCT02319759, NCT03162796, NCT03158285, and NCT03796858.© 2023. The Author(s).