Department of Colorectal Surgery, Cancer Hospital of China Medical University, Liaoning Cancer Hospital and Institute, Shenyang, China.
Department of Pharmacy, Cancer Hospital of China Medical University, Liaoning Cancer Hospital and Institute, Shenyang, China.
BMC Cancer. 2024 Apr 17;24(1):490. doi: 10.1186/s12885-024-12256-z.
Patients with rheumatologic preexisting autoimmune disease (PAD) have not been enrolled in clinical trials of immune checkpoint inhibitors (ICIs). Therefore, the risks and benefits of ICI therapy in such patients are unclear. Herein, we investigated the safety and efficacy of ICIs in rheumatologic PAD patients through a meta-analysis.
The PubMed, Cochrane Library, Embase and Web of Science databases were searched for additional studies. We analyzed the following data through Stata software: incidence of total irAEs (TirAEs), rate of flares, incidence of new on-set irAEs, rate of discontinuation, objective response rate (ORR) and disease control rate (DCR).
We identified 23 articles including 643 patients with rheumatologic PAD. The pooled incidences of TirAEs, flares and new-onset irAEs were 64% (95% CI 55%-72%), 41% (95% CI 31%-50%), and 33% (95% CI 28%-38%), respectively. In terms of severity, the incidences were 7% (95% CI 2%-14%) for Grade 3-4 flares and 12% (95% CI 9%-15%) for Grade 3-4 new-onset irAEs. Patients with RA had a greater risk of flares than patients with other rheumatologic PADs did (RR = 1.35, 95% CI 1.03-1.77). The ORR and DCR were 30% and 44%, respectively. Baseline anti-rheumatic treatment was not significantly associated with the frequency of flares (RR = 1.05, 95% CI 0.63-1.77) or the ORR (RR = 0.45, 95% CI 0.12-1.69).
Patients with rheumatologic PAD, particularly those with RA, are susceptible to relapse of their rheumatologic disease following ICI therapy. ICIs are also effective for treating rheumatologic PAD patients. PROSPECTIVE REGISTER OF SYSTEMATIC REVIEWS (PROSPERO): number CRD 42,023,439,702.
患有风湿性自身免疫性疾病(PAD)的患者尚未被纳入免疫检查点抑制剂(ICI)的临床试验。因此,ICI 治疗在这类患者中的风险和获益尚不清楚。在此,我们通过荟萃分析研究了 ICI 在风湿性 PAD 患者中的安全性和疗效。
检索 PubMed、Cochrane Library、Embase 和 Web of Science 数据库,以获取其他研究。我们使用 Stata 软件分析了以下数据:总免疫相关不良事件(irAEs)发生率、疾病活动度复发率、新发生 irAEs 发生率、停药率、客观缓解率(ORR)和疾病控制率(DCR)。
我们共纳入 23 篇文章,共计 643 例风湿性 PAD 患者。irAEs、疾病活动度复发和新发生 irAEs 的总发生率分别为 64%(95%CI 55%-72%)、41%(95%CI 31%-50%)和 33%(95%CI 28%-38%)。在严重程度方面,3-4 级疾病活动度复发和 3-4 级新发生 irAEs 的发生率分别为 7%(95%CI 2%-14%)和 12%(95%CI 9%-15%)。与其他风湿性 PAD 患者相比,类风湿关节炎(RA)患者更易发生疾病活动度复发(RR=1.35,95%CI 1.03-1.77)。ORR 和 DCR 分别为 30%和 44%。基线抗风湿治疗与疾病活动度复发频率(RR=1.05,95%CI 0.63-1.77)或 ORR(RR=0.45,95%CI 0.12-1.69)无显著相关性。
患有风湿性 PAD 的患者,特别是患有 RA 的患者,在接受 ICI 治疗后容易出现自身免疫性疾病的复发。ICI 治疗对风湿性 PAD 患者也是有效的。前瞻性注册系统评价(PROSPERO):注册号 CRD42023439702。