Aymon Romain, Mongin Denis, Guemara Romain, Salis Zubeyir, Askling Johan, Choquette Denis, Codreanu Catalin, Di Giuseppe Daniela, Flouri Irini, Huschek Doreen, Hyrich Kimme L, Iannone Florenzo, Kvien Tore K, Leeb Burkhard F, Nordström Dan, Otero-Varela Lucia, Pavelka Karel, Pombo-Suarez Manuel, Rodrigues Ana, Rotar Ziga, Sidiropoulos Prodromos, Provan Sella A, Strangfeld Anja, Nina Trokovic, Zavada Jakub, Kearsley-Fleet Lianne, Courvoisier Delphine S, Finckh Axel, Lauper Kim
Department of Rheumatology, Geneva University Hospital, Geneva, Switzerland.
University of Montpellier and Physiology and Experimental Medicine of the Heart and Muscles, Montpellier, France.
Arthritis Rheumatol. 2025 Sep;77(9):1194-1204. doi: 10.1002/art.43188. Epub 2025 May 21.
Our objective was to assess the incidence of major adverse cardiovascular events (MACEs) in patients with rheumatoid arthritis (RA) treated with JAK inhibitors (JAKi), tumor necrosis factor inhibitors (TNFi), or biologic disease-modifying antirheumatic drugs with other modes of action (bDMARD-OMA) in a multicountry, real-world population.
Patients with RA from 15 registries in the JAK-pot collaboration were included. MACE incidence was analyzed using two approaches: a within-registry analysis aggregating country-specific estimates from registers with >25 incident MACEs through meta-analysis and an individual-level data combined analysis. We used adjusted linear mixed Poisson regression to obtain incidence rate ratios (IRRs) of MACEs between treatment groups, accounting for multiple treatment courses.
The study included 73,008 treatment courses (16,417 JAKi, 35,373 TNFi, and 21,218 bDMARD-OMA) and 828 incident MACEs among 51,233 patients. Median follow-up time was 1.3 years, with most of the follow-up concentrated in the first two years of treatment. Incidence rates were 7.0, 7.6, and 11.8 per 1,000 person-years for JAKi, TNFi, and bDMARD-OMA, respectively. Compared to TNFi, JAKi (within-registry adjusted IRR 0.89, 95% confidence interval [CI] 0.63-1.25) had similar incidence rates of MACEs and bDMARD-OMA had higher rates (within-registry adjusted IRR 1.35, 95% CI 1.10-1.66). Combined analysis showed similar results.
Observational data from the JAK-pot collaboration show no evidence of an increase in cardiovascular events during the first two years of use with JAKi compared to TNFi in the general RA population.
我们的目的是评估在一个多国家的真实世界人群中,接受Janus激酶抑制剂(JAKi)、肿瘤坏死因子抑制剂(TNFi)或具有其他作用方式的生物性改善病情抗风湿药物(bDMARD-OMA)治疗的类风湿关节炎(RA)患者中,主要不良心血管事件(MACE)的发生率。
纳入JAK-pot合作项目中15个登记处的RA患者。采用两种方法分析MACE发生率:一种是登记处内分析,通过荟萃分析汇总来自有>25例MACE事件登记的国家特定估计值;另一种是个体水平数据合并分析。我们使用调整后的线性混合泊松回归来获得治疗组之间MACE的发病率比(IRR),同时考虑多个治疗疗程。
该研究包括73,008个治疗疗程(16,417个JAKi疗程、35,373个TNFi疗程和21,218个bDMARD-OMA疗程),51,233例患者中有828例发生MACE事件。中位随访时间为1.3年,大部分随访集中在治疗的前两年。JAKi、TNFi和bDMARD-OMA的发病率分别为每1000人年7.0、7.6和11.8例。与TNFi相比,JAKi的MACE发生率相似(登记处内调整后的IRR为0.89,95%置信区间[CI]为0.63-1.25),而bDMARD-OMA的发生率更高(登记处内调整后的IRR为1.35,95%CI为1.10-1.66)。合并分析显示了相似的结果。
JAK-pot合作项目的观察数据表明,在一般RA人群中,与TNFi相比,JAKi使用的前两年没有证据显示心血管事件增加。