Lauper Kim, Mongin Denis, Iannone Florenzo, Klami Kristianslund Eirik, Kvien Tore K, Nordström Dan, Pavelka Karel, Pombo-Suarez Manuel, Rotar Ziga, Santos Maria Jose, Codreanu Catalin, Lukina Galina, Courvoisier Delphine S, Gabay Cem
Division of Rheumatology, Geneva University Hospitals, Geneva, Switzerland.
SCQM Registry, Zurich, Switzerland.
RMD Open. 2018 Nov 5;4(2):e000809. doi: 10.1136/rmdopen-2018-000809. eCollection 2018.
To compare the real-word effectiveness of subcutaneous tocilizumab (TCZ-SC) and intravenous tocilizumab (TCZ-IV) in rheumatoid arthritis (RA).
Patients with RA with TCZ from eight European registries were included. Drug retention was compared using unadjusted Kaplan-Meier and Cox models adjusted for baseline patient, disease and treatment characteristics, using a strata term for year of treatment initiation and country of registry. The proportions of patients achieving Clinical Disease Activity Index (CDAI) remission and low disease activity (LDA) at 1 year were compared using samples matched on the same covariates and corrected for attrition using LUNDEX.
3448 patients were retrieved, 2414 with TCZ-IV and 1034 with TCZ-SC. Crude median retention was 3.52 years (95% CI 3.22 to 3.85) for TCZ-IV and 2.12 years for TCZ-SC (95% CI 1.88 to 2.38). In a country-stratified and year of treatment initiation-stratified, covariate-adjusted analysis, hazards of discontinuation were similar between TCZ-SC and TCZ-IV treated patients (HR 0.93, 95% CI 0.80 to 1.09). The average adjusted CDAI change at 1 year was similar in both groups (-6.08). After matching, with 560 patients in each group, CDAI remission corrected for attrition at 1 year was also similar between TCZ-SC and TCZ-IV (10.4% in TCZ-IV vs 12.8% in TCZ-SC (difference: 2.4%, bootstrap 95% CI -2.1% to 7.6%)), but CDAI LDA was lower in TCZ-IV patients: 41.0% in TCZ-IV versus 49.1% in TCZ-SC (difference: 8.0 %; bootstrap 95% CI 2.4% to 12.4%).
With similar retention and effectiveness, TCZ-SC is an adequate alternative to TCZ-IV for RA. When possible, considering the costs of the TCZ-IV route, TCZ-SC should be the preferred mode of administration.
比较皮下注射托珠单抗(TCZ-SC)和静脉注射托珠单抗(TCZ-IV)治疗类风湿关节炎(RA)的实际疗效。
纳入来自八个欧洲登记处使用托珠单抗治疗的RA患者。使用未调整的Kaplan-Meier模型和针对基线患者、疾病及治疗特征进行调整的Cox模型比较药物留存率,使用治疗起始年份和登记国家的分层项。使用在相同协变量上匹配的样本并通过LUNDEX校正损耗,比较两组患者在1年时达到临床疾病活动指数(CDAI)缓解和低疾病活动度(LDA)的比例。
共检索到3448例患者,其中2414例使用TCZ-IV,1034例使用TCZ-SC。TCZ-IV的粗中位数留存时间为3.52年(95%CI 3.22至3.85),TCZ-SC为2.12年(95%CI 1.88至2.38)。在按国家分层和治疗起始年份分层的协变量调整分析中,TCZ-SC组和TCZ-IV组患者的停药风险相似(HR 0.93,95%CI 0.80至1.09)。两组在1年时的平均调整后CDAI变化相似(-6.08)。匹配后,每组各有560例患者,TCZ-SC组和TCZ-IV组在1年时校正损耗后的CDAI缓解率也相似(TCZ-IV组为10.4%,TCZ-SC组为12.8%(差异:2.4%,自抽样95%CI -2.1%至7.6%)),但TCZ-IV组患者的CDAI-LDA较低:TCZ-IV组为41.0%,TCZ-SC组为49.1%(差异:8.0%;自抽样95%CI 2.4%至12.4%)。
TCZ-SC与TCZ-IV具有相似的留存率和疗效,是RA治疗中TCZ-IV的合适替代方案。在可能的情况下,考虑到TCZ-IV给药途径的成本,TCZ-SC应作为首选给药方式。