乌帕替尼治疗难治性类风湿性关节炎的疗效与安全性分析OA
Efficacy and safety of upadacitinib in the treatment of difficult-to-treat rheumatoid arthritis
目的 评估真实世界中乌帕替尼(UPA)治疗难治性类风湿性关节炎(D2T-RA)患者的疗效与安全性.方法 纳入2023年5月至2025年4月该院住院或门诊就诊的D2T-RA成人患者,采用 UPA治疗,在治疗第4、12、24、48周进行随访.统计分析患者低疾病活动度(LDA)、炎症相关指标[C反应蛋白(CRP)、红细胞沉降率(ESR)]、关节受累指标[28个压痛关节计数(TJC28)、28个肿胀关节计数(SJC28)]、疼痛视觉模拟评分(VAS)变化情况及不良事件的发生情况,计算基于CRP的28个关节疾病活动评分(DAS28-CRP)、临床疾病活动指数(CDAI)等.结果 随访48周内,各项疗效指标较基线均显著下降(P<0.001).炎症相关指标中,CRP由8.98(1.75,22.39)mg/L降至1.85(0.94,5.79)mg/L,ESR由32.50(18.75,49.00)mm/h降至16.00(9.75,23.00)mm/h.关节受累指标方面,TJC28由13.00(8.00,20.00)个降至1.00(0.00,6.00)个,SJC28由8.00(4.00,16.00)个降至0.00(0.00,2.00)个.临床评估指标[VAS、健康评估问卷残疾指数、DAS28-CRP、CDAI等]也随时间呈下降趋势(P<0.001).事后分析显示,各疗效指标在治疗早期即显著改善(P<0.001).DAS28-CRP标准下的LDA率在第4、12、24、48周时分别为31.34%、61.19%、68.66%和68.65%,缓解率分别为23.88%、43.28%、59.70%和61.19%.CDAI标准下 LDA 率在相应时间点依次为22.39%、50.75%、64.18%和65.67%,缓解率分别为10.64%、23.88%、34.32%和35.82%.疼痛缓解率从4周的38.80%逐步上升至48周的76.11%.功能状态改善率也呈递增趋势,分别为19.40%、34.33%、49.25%和55.22%.UPA治疗期间无严重不良事件发生.结论 UPA在D2T-RA患者的治疗中表现出持续、显著的临床疗效,安全性和耐受性良好,且疗效不受既往治疗或合并用药影响.
Objective To evaluate the efficacy and safety of upadacitinib(UPA)in the treatment of pa-tients with difficult-to-treat rheumatoid arthritis(D2T-RA)in a real-world setting.Methods Adult patients with D2T-RA who were hospitalized or treated as outpatients in the hospital from May 2023 to April 2025 and received UPA were enrolled.Follow-up assessments were conducted at weeks 4,12,24,and 48.The changes in patients'low disease activity(LDA),inflammatory markers[C-reactive protein(CRP),erythrocyte sedimentation rate(ESR)},joint involvement indicators[28 tender joint count(TJC28),28 swollen joint count(SJC28)},pain visual analog scale(VAS),and the occurrence of adverse events were analyzed,and the CRP-based 28-joint disease activity score(DAS28-CRP),clinical disease activity index(CDAI),etc.were calculated.Results Within 48 weeks of follow-up,all efficacy indicators were significantly reduced compared with baseline(P<0.001).Among in-flammatory markers,C-reactive protein(CRP)decreased from 8.98(1.75,22.39)mg/L to 1.85(0.94,5.79)mg/L,and erythrocyte sedimentation rate(ESR)decreased from 32.50(18.75,49.00)mm/h to 16.00(9.75,23.00)mm/h.Regarding joint involvement,tender joint count in 28 joints(TJC28)decreased from 13.00(8.00,20.00)to 1.00(0.00,6.00),and swollen joint count in 28 joints(SJC28)decreased from 8.00(4.00,16.00)to 0.00(0.00,2.00).Clinical assessment indicators[VAS,health assessment questionnaire-disability index,DAS28-CRP,and CDAI,etc.]also showed a downward trend over time(P<0.001).Post hoc analysis demonstrated that all efficacy indicators improved significantly at an early stage of treatment(P<0.001).Ac-cording to DAS28-CRP criteria,the low disease activity(LDA)rates at weeks 4,12,24,and 48 were 31.34%,61.19%,68.66%,and 68.65%,respectively,while the remission rates were 23.88%,43.28%,59.70%,and 61.19%,respectively.According to CDAI criteria,the LDA rates at the corresponding time points were 22.39%,50.75%,64.18%,and 65.67%,respectively,and the remission rates were 10.64%,23.88%,34.32%,and 35.82%,respectively.The pain relief rate increased progressively from 38.80%at week 4 to 76.11%at week 48.The functional improvement rate also showed an increasing trend,reaching 19.40%,34.33%,49.25%,and 55.22%at weeks 4,12,24,and 48,respectively.No serious adverse events occurred during UPA treatment.Conclusion UPA demonstrated sustained and significant clinical efficacy in patients with D2T-RA,with good safety and tolerability.Its efficacy was not affected by previous treatments or con-comitant medications.
孙淑玉;李嵩;常新;武剑
苏州大学附属第一医院风湿免疫科,江苏 苏州 215000苏州大学附属第一医院风湿免疫科,江苏 苏州 215000苏州大学附属第一医院风湿免疫科,江苏 苏州 215000苏州大学附属第一医院风湿免疫科,江苏 苏州 215000
医药卫生
难治性类风湿性关节炎乌帕替尼疗效安全性
Difficult-to-treat rheumatoid arthritisUpadacitinibEfficacySafety
《现代医药卫生》 2026 (5)
1044-1048,1058,6
苏州市基础研究试点项目(SSD2024033).
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