Zuckerman Benjamin P, Gibson Mark, Roy Ritika, Hughes Mark, Mehta Daksh, Yang Zijing, Adas Maryam, Ng Kenrick, Russell Mark D, Cope Andrew, Norton Sam, Galloway James
Centre for Rheumatic Diseases, King's College London, London, UK.
Guy's King's and St Thomas' Medical School, King's College London, London, UK.
Rheumatology (Oxford). 2025 Jun 1;64(6):3280-3287. doi: 10.1093/rheumatology/keaf114.
To estimate the association between abatacept use and the incidence of malignancy excluding non-melanomatous skin cancers (NMSCs).
Systematic database searches were performed, to April 2024, to identify phase II/III/IV randomized clinical trials (RCTs), long-term extension (LTE) and observational cohort studies of abatacept in people with rheumatoid arthritis and psoriatic arthritis. Network and pairwise meta-analyses were performed to estimate incidence rate ratios (IRRs) for malignancy excluding NMSC, comparing abatacept with placebo and tumour necrosis factor inhibitors (TNFi) in RCT/LTE studies. Pairwise meta-analyses evaluated the same outcome in observational studies, comparing abatacept with conventional synthetic DMARDs (csDMARDs) and biologic/targeted synthetic disease modifying antirheumatic drugs (b/tsDMARDs).
In 18 eligible RCTs and 10 LTE studies, there were 15 535 person-years of exposure to abatacept, 1495 to placebo and 733 to TNFi. In network meta-analyses of combined RCT/LTE data, the incidence of all malignancies excluding NMSCs was not significantly different between abatacept and placebo (IRR 0.58; 95% CI 0.32-1.09) or TNFi (IRR 0.72; 95% 0.27-1.87). In observational data, the incidence of malignancy was higher with abatacept, relative to other b/tsDMARDs (IRR 1.21; 95% CI 1.15-1.28), but not significantly different compared with csDMARDs (IRR 0.97; 95% CI 0.90-1.06).
Abatacept was associated with a higher incidence of malignancy compared with other b/tsDMARDs in observational studies, but not when compared with placebo or TNFi in RCT/LTE data. Further pharmacovigilance data is essential to help elucidate whether abatacept modifies cancer risk.
CRD42023382314.
评估阿巴西普的使用与非黑色素瘤皮肤癌（NMSC）以外的恶性肿瘤发病率之间的关联。
进行系统的数据库检索，至2024年4月，以识别类风湿关节炎和银屑病关节炎患者中阿巴西普的II/III/IV期随机临床试验（RCT）、长期扩展（LTE）和观察性队列研究。进行网状和成对荟萃分析，以估计排除NMSC的恶性肿瘤发病率比（IRR），在RCT/LTE研究中比较阿巴西普与安慰剂和肿瘤坏死因子抑制剂（TNFi）。成对荟萃分析在观察性研究中评估相同结局，比较阿巴西普与传统合成改善病情抗风湿药（csDMARDs）以及生物/靶向合成改善病情抗风湿药（b/tsDMARDs）。
在18项符合条件的RCT和10项LTE研究中，阿巴西普的暴露人年数为15535，安慰剂为1495，TNFi为733。在RCT/LTE联合数据的网状荟萃分析中，阿巴西普与安慰剂（IRR 0.58；95% CI 0.32 - 1.09）或TNFi（IRR 0.72；95% 0.27 - 1.87）之间，排除NMSC的所有恶性肿瘤发病率无显著差异。在观察性数据中，与其他b/tsDMARDs相比，阿巴西普的恶性肿瘤发病率更高（IRR 1.21；95% CI 1.15 - 1.28），但与csDMARDs相比无显著差异（IRR 0.97；95% CI 0.90 - 1.06）。
在观察性研究中，与其他b/tsDMARDs相比，阿巴西普与较高的恶性肿瘤发病率相关，但在RCT/LTE数据中与安慰剂或TNFi相比则不然。进一步的药物警戒数据对于帮助阐明阿巴西普是否改变癌症风险至关重要。
PROSPERO注册号：CRD42023382314。
