Gabay Cem, Riek Myriam, Hetland Merete Lund, Hauge Ellen-Margrethe, Pavelka Karel, Tomšič Matija, Canhao Helena, Chatzidionysiou Katerina, Lukina Galina, Nordström Dan C, Lie Elisabeth, Ancuta Ioan, Hernández M Victoria, van Riel Piet L M C, van Vollenhoven Ronald, Kvien Tore K
Division of Rheumatology, University Hospitals of Geneva, Geneva, Switzerland.
SCQM Foundation, Zurich, Switzerland.
Ann Rheum Dis. 2016 Jul;75(7):1336-42. doi: 10.1136/annrheumdis-2015-207760. Epub 2015 Sep 15.
To examine the effectiveness of tocilizumab (TCZ) with and without synthetic disease-modifying antirheumatic drugs (sDMARDs) in a large observational study.
Patients with rheumatoid arthritis treated with TCZ who had a baseline visit and information on concomitant sDMARDs were included. According to baseline data, patients were considered as taking TCZ as monotherapy or combination with sDMARDs. Main study outcomes were the change of Clinical Disease Activity Index (CDAI) and TCZ retention. The prescription of TCZ as monotherapy was analysed using logistic regression. CDAI change was analysed with a mixed-effects model for longitudinal data. TCZ retention was analysed with a stratified extended Cox model.
Multiple-adjusted analysis suggests that prescription of TCZ as monotherapy varied according to age, corticosteroid use, country of the registry and year of treatment initiation. The change of disease activity assessed by CDAI as well as the likelihood to be in remission were not significantly different whether TCZ was used as monotherapy or in combination with sDMARDs in a covariate-adjusted analysis. Estimates for unadjusted median TCZ retention were 2.3 years (95% CI 1.8 to 2.7) for monotherapy and 3.7 years (lower 95% CI limit 3.1, upper limit not estimable) for combination therapies. In a covariate-adjusted analysis, TCZ retention was also reduced when used as monotherapy, with an increasing difference between mono and combination therapy over time after 1.5 years (p=0.002).
TCZ with or without concomitant sDMARDs resulted in comparable clinical response as assessed by CDAI change, but TCZ retention was shorter under monotherapy of TCZ.
在一项大型观察性研究中检验托珠单抗(TCZ)联合或不联合合成改善病情抗风湿药(sDMARDs)的有效性。
纳入接受TCZ治疗且有基线访视及合并sDMARDs信息的类风湿关节炎患者。根据基线数据,患者被视为接受TCZ单药治疗或与sDMARDs联合治疗。主要研究结局为临床疾病活动指数(CDAI)的变化和TCZ的保留率。使用逻辑回归分析TCZ单药治疗的处方情况。采用纵向数据混合效应模型分析CDAI的变化。使用分层扩展Cox模型分析TCZ的保留率。
多因素调整分析表明,TCZ单药治疗的处方情况因年龄、皮质类固醇使用情况、登记国家和治疗起始年份而异。在协变量调整分析中,无论TCZ是单药使用还是与sDMARDs联合使用,通过CDAI评估的疾病活动变化以及缓解的可能性均无显著差异。单药治疗未经调整的TCZ中位保留时间估计为2.3年(95%CI 1.8至2.7),联合治疗为3.7年(95%CI下限3.1,上限不可估计)。在协变量调整分析中,TCZ单药使用时其保留率也降低,1.5年后单药治疗与联合治疗之间的差异随时间增加(p = 0.002)。
无论是否联合sDMARDs,通过CDAI变化评估,TCZ产生的临床反应相当,但TCZ单药治疗时其保留时间较短。