免疫检查点抑制剂（ICI）治疗的患者中，风湿免疫相关不良事件（R-irAEs）发生率为5-15％，与其他irAEs不同，它倾向于是慢性的。本研究旨在调查影响癌症和R-irAE结果的因素，特别关注抗炎治疗的不良影响。在这项前瞻性、多中心、长期观察性研究中，全面分析了接受ICI治疗的恶性黑色素瘤（MM, n=50）和非小细胞肺癌（NSCLC, n=41）患者中的R-irAEs。研究对象于2018年8月1日至2022年12月11日期间被纳入研究。 中位随访时间为33个月，在MM患者中，进展疾病或死亡发生在66.0％和30.0％，在NSCLC患者中，进展疾病或死亡发生在63.4％和39.0％的患者中。男性性别（无进展生存（PFS）： p=0.013，总体生存（OS）： p=0.009）、患有已存在病症的急性加重（对比新发R-irAEs，PFS： p=0.010）和趋势性最大糖皮质激素（GC）剂量> 10mg，特别是≥ 1mg/kg泼尼松当量（性别调整的PFS： p= 0.056，OS： p=0.051）与恶性肿瘤结果较差相关。接受疾病修饰类抗风湿药物（DMARDs）的患者显示出较长的PFS（n=14，p=0.011）和OS（n=20，p=0.018）。这些变量对PFS和/或OS的影响在调整的Cox回归模型中持续存在。此外，GC治疗与恶性肿瘤诊断时间和ICI开始至R-irAE发作之间的潜伏期呈负相关关系（所有p<0.05）。两种研究的癌症类型中，R-irAE特征和结果独立于其他基线患者特征。男性性别，已存在的风湿病学疾病急性加重和广泛的GC治疗似乎与不良的癌症结果相关，而DMARD的使用对结果有积极影响。这些发现挑战了目前对于R-irAE限制性DMARD使用的常规研究成果，从而为R-irAE患者的更好策略和随机对照试验铺平了道路。© 作者（或其雇主）2023年。在CC BY-NC下允许重新使用，不得进行商业再使用。由BMJ出版。

Rheumatic immune-related adverse events (R-irAEs) occur in 5-15% of patients receiving immune checkpoint inhibitors (ICI) and, unlike other irAEs, tend to be chronic. Herein, we investigate the factors influencing cancer and R-irAEs outcomes with particular focus on adverse effects of anti-inflammatory treatment.In this prospective, multicenter, long-term, observational study, R-irAEs were comprehensively analyzed in patients with malignant melanoma (MM, n=50) and non-small cell lung cancer (NSCLC, n=41) receiving ICI therapy who were enrolled in the study between August 1, 2018, and December 11, 2022.After a median follow-up of 33 months, progressive disease or death occurred in 66.0% and 30.0% of MM and 63.4% and 39.0% of patients with NSCLC. Male sex (progression-free survival (PFS): p=0.013, and overall survival (OS): p=0.009), flare of a pre-existing condition (vs de novo R-irAE, PFS: p=0.010) and in trend maximum glucocorticoid (GC) doses >10 mg and particularly ≥1 mg/kg prednisolone equivalent (sex-adjusted PFS: p=0.056, OS: p=0.051) were associated with worse cancer outcomes. Patients receiving disease-modifying antirheumatic drugs (DMARDs) showed significantly longer PFS (n=14, p=0.011) and OS (n=20, p=0.018). Effects of these variables on PFS and/or OS persisted in adjusted Cox regression models. Additionally, GC treatment negatively correlated with the time from diagnosis of malignancy and the latency from ICI start until R-irAE onset (all p<0.05). R-irAE features and outcomes were independent of other baseline patient characteristics in both studied cancer entities.Male sex, flare of pre-existing rheumatologic conditions and extensive GC treatment appeared to be linked with unfavorable cancer outcomes, while DMARD use had a favorable impact. These findings challenge the current dogma of restrictive DMARD use for R-irAE and thus may pave the way to better strategies and randomized controlled trials for the growing number of patients with R-irAE.© Author(s) (or their employer(s)) 2023. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.