Continuation of Methotrexate Resulted in Better Clinical and Radiographic Outcomes Than Discontinuation upon Starting Etanercept in Patients with Rheumatoid Arthritis: 52-week Results from the JESMR Study
Continuation of Methotrexate Resulted in Better Clinical and Radiographic Outcomes Than Discontinuation upon Starting Etanercept in Patients with Rheumatoid Arthritis: 52-week Results from the JESMR Study
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DOI：
10.3899/jrheum.110014
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发表时间：
2011-08-01
影响因子：
3.9
通讯作者：
Takeuchi, Tsutomu
中科院分区：
文献类型：
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作者：
Kameda, Hideto;Kanbe, Katsuaki;Takeuchi, Tsutomu
Objective.在日本开展的“依那西普治疗活动性类风湿关节炎的有效性和安全性”（JESMR）研究的目的是比较在活动性类风湿关节炎（RA）患者中开始使用依那西普（ETN）时继续与停用甲氨蝶呤（MTX）的疗效。总共有151名服用MTX的活动性RA患者被随机分配到ETN 25 1112每周两次，6-8 mg/周MTX（E+M组）或ETN单独治疗（E组）。第52周的主要终点是通过货车der Heijde改良Sharp评分评估的放射学进展。第52周时，E+M组和E组之间的总评分平均进展无统计学显著差异（分别为0.8 vs 3.6; p = 0.06）。然而，在第24周和第52周之间观察到放射学进展存在显著差异（0.3 vs 2.5; p = 0.03），E+M组糜烂评分的平均进展为阴性，在第52周时显著优于E组（-0.2 vs 1.8; p = 0.02）。在临床上，第52周时美国流变学会（ACR）-N值的累积概率图清楚地表明E+M组的缓解上级E组。E+M组第52周的ACR 20、50和70应答率（86.3%、76.7%和50.7%）显著高于E组（分别为63.8%; p = 0.003、43.5%; p < 0.0001和29.0%; p = 0.01）。活动性RA患者在开始ETN治疗时应继续使用MTX。（ClinicalTrials.gov：NCT 00688103）（2011年5月15日首次发布; J Rheumol 2011;38：1585-92; doi：10.3899/jrheum.110014）
Objective. The aim of the Efficacy and Safety of Etanercept on Active Rheumatoid Arthritis Despite Methotrexate Therapy in Japan (JESMR) study is to compare the efficacy of continuation versus discontinuation of methotrexate (MTX) when starting etanercept (ETN) in patients with active rheumatoid arthritis (RA).Methods. In total, 151 patients with active RA who had been taking MTX were randomized to either ETN 25 1112 twice a week with 6-8 mg/week MTX (the E+M group), or ETN alone (the E group). The primary endpoint at Week 52 was the radiographic progression assessed by van der Heijde-modified Sharp score.Results. The mean progression in total score at Week 52 was not significantly different, statistically, between the E+M group and the E group (0.8 vs 3.6, respectively; p = 0.06). However, a significant difference was observed in radiographic progression between Weeks 24 and 52 (0.3 vs 2.5; p = 0.03), and the mean progression of the erosion score was negative in the E+M group, which was significantly better than the E group at Week 52 (-0.2 vs 1.8; p = 0.02). Clinically, the cumulative probability plot of the American College of Rheumatology (ACR)-N values at Week 52 clearly demonstrated a superior response in the E+M group than in the E group. ACR20, 50, and 70 response rates at Week 52 in the E+M group (86.3%, 76.7%, and 50.7%) were significantly greater than those in the E group (63.8%; p = 0.003, 43.5%; p < 0.0001 and 29.0%; p = 0.01, respectively).Conclusion. MTX should be continued when starting ETN in patients with active RA. (ClinicalTrials.gov: NCT00688103) (First Release May 15 2011; J Rheumatol 2011;38:1585-92; doi:10.3899/jrheum.110014)