阿达木单抗与托珠单抗治疗活动性重度大动脉炎患者的疗效和安全性：一项开放标签研究。
Treatment efficacy and safety of adalimumab versus tocilizumab in patients with active and severe Takayasu arteritis: an open-label study.
作者信息
Wang Jinghua, Kong Xiufang, Ma Lili, Ding Zhenqi, Chen Huiyong, Chen Rongyi, Jin Xuejuan, Chen Caizhong, Lin Jiang, Jiang Lindi
机构信息
Department of Rheumatology, Zhongshan Hospital, Fudan University, Shanghai, China.
Department of Cardiology, Zhongshan Hospital, Fudan University, Shanghai Institute of Cardiovascular Diseases, Shanghai, China.
出版信息
Rheumatology (Oxford). 2024 May 2;63(5):1359-1367. doi: 10.1093/rheumatology/kead387.
OBJECTIVE
This study aimed to compare the efficacy and safety of adalimumab (ADA) vs tocilizumab (TCZ) in patients with Takayasu arteritis (TAK).
METHODS
This was a randomized, controlled, open-label study. Forty patients with active and severe TAK were enrolled. They were treated with ADA (n = 21) combined with glucocorticoids (GCs) and MTX or TCZ (n = 19) combined with GCs and MTX. The planned follow-up duration was 12 months. The primary end point was the efficacy rate (ER) at 6 months. The secondary end points included ER at 9 and 12 months, relapse rate, GC tapering, adverse effects, and life quality changes during treatment.
RESULTS
In the intention-to-treat (ITT) population, the ER at 6 months was higher in the ADA group (85.71% vs 52.63%, P = 0.02). A similar direction of effect was noted in the per-protocol set (89.47% vs 62.50%, P = 0.06). The percentages of patients who achieved a GC dose of ≤10 mg/day at 6 months were similar between the ADA and TCZ groups (47.37% vs 43.75%, P = 0.83). The ERs at 9 and 12 months were similar between the two groups (P > 0.05). During the first 12 months of treatment, the relapse rate and adverse event incidence were comparable between the two groups (ADA vs TCZ: 9.52% vs 10.53%, P = 0.96; 38.10% vs 47.37%, P = 0.55, respectively).
CONCLUSION
ADA combined with GCs and MTX may be more efficacious than TCZ combined with GCs and MTX among patients with active and severe TAK.
TRIAL REGISTRATION
Clinicaltrials.gov; NCT04300686.
目的
本研究旨在比较阿达木单抗（ADA）与托珠单抗（TCZ）治疗高安动脉炎（TAK）患者的疗效和安全性。
方法
这是一项随机、对照、开放标签研究。纳入40例活动期重度TAK患者。他们分别接受ADA（n = 21）联合糖皮质激素（GCs）和甲氨蝶呤（MTX）治疗，或TCZ（n = 19）联合GCs和MTX治疗。计划随访时间为12个月。主要终点是6个月时的有效率（ER）。次要终点包括9个月和12个月时的ER、复发率、GC减量情况、不良反应以及治疗期间生活质量的变化。
结果
在意向性分析（ITT）人群中，ADA组6个月时的ER更高（85.71%对52.63%，P = 0.02）。在符合方案集分析中也观察到类似的效应趋势（89.47%对62.50%，P = 0.06）。ADA组和TCZ组在6个月时达到GC剂量≤10 mg/天的患者百分比相似（47.37%对43.75%，P = 0.83）。两组9个月和12个月时的ER相似（P>0.05）。在治疗的前12个月，两组的复发率和不良事件发生率相当（ADA组对TCZ组：分别为9.52%对10.53%，P = 0.96；38.10%对47.37%，P = 0.55）。
结论
在活动期重度TAK患者中，ADA联合GCs和MTX可能比TCZ联合GCs和MTX更有效。
试验注册
Clinicaltrials.gov；NCT04300686。
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