Flipo René-Marc, Maillefert Jean-Francis, Chazerain Pascal, Idier Isabelle, Coudert Mathieu, Tebib Jacques
Department of Rheumatology , University Hospital , Lille , France.
Department of Rheumatology , University Hospital , Dijon , France.
RMD Open. 2017 Jan 10;3(1):e000340. doi: 10.1136/rmdopen-2016-000340. eCollection 2017.
Using a biologic disease-modifying antirheumatic drug (bDMARD) as monotherapy in clinical practice for patients with rheumatoid arthritis (RA) is common and recognised by health authorities although current guidelines recommend to combine them with conventional synthetic (cs)DMARDs. This study mainly aimed to search for real-life factors influencing the use of tocilizumab as MONO or in combination (COMBO).
In this non-interventional, prospective, national, multicentre study, data were collected every 3 months over a 12-month period in RA patients starting tocilizumab. The proportion of monotherapy patients was described, together with significant explicative factors.
Among the 577 analysed patients recruited from January 2012 to August 2013 (228 monotherapy patients; 40%), 79% were women, mean RA duration was 11±9 years, previous RA treatments included bDMARDs and csDMARDs in 75% of cases and mean Disease Activity Score 28 joints-Erythrocyte Sedimentation Rate (DAS28-ESR) was 5.2±1.3 at inclusion. Explicative factors for monotherapy were at least 65 years (OR=1.47, p=0.0485), no methotrexate within the two last years (OR=5.96, p<0.0001), past severe infection (OR=1.99, p=0.0272) and higher baseline DAS28-ESR (OR=1.22, p=0.0086). Regarding clinical results (DAS28-ESR, Clinical Disease Activity Index (CDAI) and Simple Disease Activity Index (SDAI) low disease activity and remission; ACR20/50/70 and European League Against Rheumatism (EULAR) response; Health Assessment Questionnaire Disability Index (HAQ-DI) score), no relevant differences between monotherapy and combination patients were observed at 1 year. A total of 23 tocilizumab-treated patients (4%) experienced serious infections; no new safety signals were noted with no differences between groups.
ACT-SOLO confirms the high proportion of RA patients receiving tocilizumab as MONO in clinical practice. The study also showed that clinical results at 1 year were similar between MONO and COMBO patients in a real-life setting.
NCT01474291.
在临床实践中，使用生物改善病情抗风湿药（bDMARD）单药治疗类风湿关节炎（RA）患者很常见，并且得到了卫生当局的认可，尽管当前指南建议将它们与传统合成（cs）DMARDs联合使用。本研究主要旨在寻找影响托珠单抗单药治疗或联合治疗使用的现实因素。
在这项非干预性、前瞻性、全国性、多中心研究中，在开始使用托珠单抗的RA患者中，每3个月收集一次数据，为期12个月。描述了单药治疗患者的比例以及重要的解释因素。
在2012年1月至2013年8月招募的577例分析患者中（228例单药治疗患者；40%），79%为女性，RA平均病程为11±9年，75%的病例既往RA治疗包括bDMARDs和csDMARDs，纳入时平均疾病活动评分28关节-红细胞沉降率（DAS28-ESR）为5.2±1.3。单药治疗的解释因素为年龄至少65岁（OR=1.47，p=0.0485）、过去两年内未使用甲氨蝶呤（OR=5.96，p<0.0001）、既往有严重感染（OR=1.99，p=0.0272）以及基线DAS28-ESR较高（OR=1.22，p=0.0086）。关于临床结果（DAS28-ESR、临床疾病活动指数（CDAI）和简化疾病活动指数（SDAI）低疾病活动度和缓解情况；美国风湿病学会（ACR）20/50/70和欧洲抗风湿病联盟（EULAR）反应；健康评估问卷残疾指数（HAQ-DI）评分），单药治疗组和联合治疗组在1年时未观察到相关差异。共有23例接受托珠单抗治疗的患者（4%）发生了严重感染；未发现新的安全信号，两组之间无差异。
ACT-SOLO证实了在临床实践中接受托珠单抗单药治疗的RA患者比例较高。该研究还表明，在现实环境中，单药治疗组和联合治疗组患者1年时的临床结果相似。
NCT01474291。
