Division of Clinical Epidemiology, Research Institute of McGill University Health Centre, 5252 de Maisonneuve West, Montreal, QC, Canada.
Division of Clinical Immunology and Rheumatology, University of Alabama at Birmingham, 619 19th Street South, Birmingham, AL, SRC 076, USA.
Arthritis Res Ther. 2018 Mar 23;20(1):60. doi: 10.1186/s13075-018-1539-6.
Tofacitinib is the first oral Janus kinase inhibitor approved for the treatment of rheumatoid arthritis (RA). We compared the effectiveness and safety of tofacitinib, disease-modifying antirheumatic drugs (DMARDs), tumor necrosis factor inhibitors (TNFi), and non-TNF biologics in patients with RA previously treated with methotrexate.
We used MarketScan® databases (2011-2014) to study methotrexate-exposed patients with RA who were newly prescribed tofacitinib, DMARDs other than methotrexate, and biologics. The date of first prescription was defined as the cohort entry. The therapy was considered effective if all of the following criteria from a claims-based algorithm were achieved at the first year of follow-up: high adherence, no biologic or tofacitinib switch or addition, no DMARD switch or addition, no increase in dose or frequency of index drug, no more than one glucocorticoid joint injection, and no new/increased oral glucocorticoid dose. The safety outcome was serious infections requiring hospitalization. Non-TNF biologics comprised the reference group.
We included 21,832 patients with RA, including 0.8% treated with tofacitinib, 24.7% treated with other DMARDs, 61.2% who had started therapy with TNFi, and 13.3% treated with non-TNF biologics. The rates of therapy effectiveness were 15.4% for tofacitinib, 11.1% for DMARDs, 18.6% for TNFi, and 19.8% for non-TNF biologics. In adjusted analyses, tofacitinib and non-TNF biologics appeared to have similar effectiveness rates, whereas DMARD initiators were less effective than non-TNF biologics. We could not clearly establish if tofacitinib was associated with a higher rate of serious infections.
In patients with RA previously treated with methotrexate, our comparisons of tofacitinib with non-TNF biologics, though not definitive, did not demonstrate differences with respect to hospitalized infections or effectiveness.
托法替布是首个获批用于治疗类风湿关节炎（RA）的口服 Janus 激酶抑制剂。我们比较了托法替布、甲氨蝶呤以外的改善病情抗风湿药（DMARDs）、肿瘤坏死因子抑制剂（TNFi）和非 TNF 生物制剂在既往接受甲氨蝶呤治疗的 RA 患者中的有效性和安全性。
我们使用 MarketScan®数据库（2011-2014 年）研究了新处方托法替布、甲氨蝶呤以外的 DMARD 和生物制剂的、既往接受甲氨蝶呤治疗的 RA 患者。首次处方日期定义为队列入组日期。如果在随访的第一年通过一种基于索赔的算法达到以下所有标准，则认为治疗有效：高依从性、无生物制剂或托法替布转换或添加、无 DMARD 转换或添加、无指数药物剂量增加或频率增加、无超过一次糖皮质激素关节注射、无新/增加的口服糖皮质激素剂量。安全性结局为需要住院治疗的严重感染。非 TNF 生物制剂为参照组。
我们纳入了 21832 例 RA 患者，其中 0.8%接受托法替布治疗、24.7%接受其他 DMARD 治疗、61.2%接受 TNFi 治疗、13.3%接受非 TNF 生物制剂治疗。托法替布、DMARD、TNFi 和非 TNF 生物制剂的治疗有效率分别为 15.4%、11.1%、18.6%和 19.8%。在调整后的分析中，托法替布和非 TNF 生物制剂的疗效似乎相似，而 DMARD 起始治疗者的疗效不如非 TNF 生物制剂。我们无法明确确定托法替布是否与更高的严重感染发生率相关。
在既往接受甲氨蝶呤治疗的 RA 患者中，我们对托法替布与非 TNF 生物制剂的比较，虽然不具有决定性，但并未显示在住院感染或疗效方面存在差异。
