Nagy György, Géher Pál, Tamási László, Drescher Edit, Keszthelyi Péter, Pulai Judit, Czirják László, Szekanecz Zoltán, Kiss Gergely, Kovács László
Department of Rheumatology & Clinical Immunology, Department of Internal Medicine & Oncology.
Department of Genetics, Cell & Immunobiology.
Rheumatol Adv Pract. 2022 May 16;6(2):rkac038. doi: 10.1093/rap/rkac038. eCollection 2022.
The aim of the SIMPACT study was to evaluate the efficacy and safety of MTX-free s.c. tocilizumab (TCZ) therapy in RA patients.
SIMPACT was an open-label, non-controlled, non-randomized, non-interventional study, in which RA patients for whom the treating physicians ordered s.c. TCZ were observed during a 24-week treatment period in Hungarian centres. Although the use of MTX was avoided during the study period, other conventional synthetic DMARDs, oral CSs and NSAIDs were allowed. Study endpoints included the change in DAS28 and clinical activity index (CDAI) scores, the proportion of patients achieving remission in the whole population and in subgroups defined based on prior RA treatment history, and age, weight or biological sex . The extent of supplementary medication use was monitored.
Three hundred and thirty-seven RA patients were enrolled in 18 study centres. TCZ therapy significantly decreased the disease activity measured by both DAS28 (=0.0001) and CDAI (=0.0001). Clinical response was more pronounced in biologic-naïve patients and was lower in patients >75 years of age. In the whole population, DAS28 ESR or CRP and CDAI remission rates were 70.10%, 78.95% and 33.59%, respectively. In patients <45 years of age, the CDAI remission rate doubled (67.86%). A significant decrease in the frequency of co-administered medication was reported, including oral CSs and DMARDs.
Real-world clinical evidence on s.c. TCZ reported here is in line with the efficacy outcomes of randomized clinical trials. Subgroup analysis revealed that TCZ was more effective in biologic-naïve patients and in those <75 years old.
ClinicalTrials.gov, http://www.clinicaltrials.gov, NCT02402686.
SIMPACT研究的目的是评估皮下注射托珠单抗（TCZ）且不使用甲氨蝶呤（MTX）治疗类风湿关节炎（RA）患者的疗效和安全性。
SIMPACT是一项开放标签、非对照、非随机、非干预性研究，在匈牙利各中心对治疗医生开具皮下注射TCZ的RA患者进行为期24周的治疗观察。尽管在研究期间避免使用MTX，但允许使用其他传统合成改善病情抗风湿药（DMARDs）、口服糖皮质激素（CSs）和非甾体抗炎药（NSAIDs）。研究终点包括疾病活动评分28（DAS28）和临床活动指数（CDAI）评分的变化、整个人群以及根据既往RA治疗史、年龄、体重或生物学性别定义的亚组中达到缓解的患者比例。监测辅助药物的使用程度。
18个研究中心共纳入337例RA患者。TCZ治疗显著降低了用DAS28（P=0.0001）和CDAI（P=0.0001）衡量的疾病活动度。初治生物制剂的患者临床反应更明显，75岁以上患者的临床反应较低。在整个人群中，DAS28基于红细胞沉降率（ESR）或C反应蛋白（CRP）以及CDAI的缓解率分别为70.10%、78.95%和33.59%。在45岁以下的患者中，CDAI缓解率翻倍（67.86%）。报告显示联合用药的频率显著降低，包括口服CSs和DMARDs。
本文报道的皮下注射TCZ的真实世界临床证据与随机临床试验的疗效结果一致。亚组分析显示，TCZ在初治生物制剂的患者和75岁以下的患者中更有效。
ClinicalTrials.gov，http://www.clinicaltrials.gov，NCT02402686 。
