早期风湿性关节炎病人接受50mg 依那西普+氨甲喋呤治疗52周,获得持续缓解之后,接受25mg 依那西普+氨甲喋呤39周,随访到65周时,联合治疗在病情控制方面较单用氨甲喋呤或安慰剂更好,但在影像学进展方面无明显差异。

20141106日《新英格兰医学杂志》

中文译文


 

【题目】早期风湿性关节炎持续缓解期的病人逐渐使用依那西普的效果

【译文】

背景:我们评价了病情缓解并接受依那西普+氨甲喋呤治疗的风湿性关节炎病人中,减少或撤出治疗的效应。 

方法:早期病情活跃且没有接受过氨甲喋呤或生物治疗的病人,接受50mg 依那西普+氨甲喋呤,每周1次,持续52周(开放标签阶段)。之后我们将在3952周有反应的病人随机分配到25mg 依那西普+氨甲喋呤组(联合治疗组)、单用氨甲喋呤组、安慰剂组治疗39周(双盲阶段)。在双盲阶段的第39周出现反应的病人即时完全退出治疗,并随访至65周(治疗撤出阶段)。主要终点是在双盲阶段的病人的持续缓解率。

结果:共招募306个病人,在双盲阶段有193人参加随机分配;131人参加治疗撤出阶段。联合治疗组与氨甲喋呤组和安慰剂组相比,有更多的病人达到主要终点的标准(分别为43/63 [63%] vs 26/65 [40% vs 15/65 [23%];联合治疗组vs氨甲喋呤组P=0.01,联合治疗组vs安慰剂组P<0.001)。到65周,联合治疗组28例(44%)、氨甲喋呤组19例(29%)、安慰剂组15例(23%)病情缓解(联合治疗组vs氨甲喋呤组 P=0.10;联合治疗组vs安慰剂组 P=0.02;氨甲喋呤vs安慰剂组 p=0.55)。影像学所见的疾病进展在各组均未见明显差别。联合治疗组报道3例(5%)严重副反应事件,氨甲喋呤组2例(3%),安慰剂组2例(3%)。

结论:早期风湿性关节炎并且病情缓解的病人,接受足量的依那西普+氨甲喋呤治疗后,持续减量接受该联合治疗,在病情控制方面较单用氨甲喋呤或安慰剂更好,但在影像学进展方面无明显差异。

 

英文原稿


[Title] Sustained remission with etanercept tapering in early rheumatoid arthritis.

[Authors] Emery P, Hammoudeh M, FitzGerald O, Combe B, Martin-Mola E, Buch MH, et al.

[Abstract]

BACKGROUND: We assessed the effects of reduction and withdrawal of treatment in patients with
rheumatoid arthritis who had a remission while receiving etanercept-plus-methotrexate therapy.

METHODS: Patients with early active disease who had not previously received methotrexate or biologic
therapy received 50 mg of etanercept plus methotrexate weekly for 52 weeks (open-label phase). We
then randomly assigned patients who had qualifying responses at weeks 39 and 52 to receive 25 mg of
etanercept plus methotrexate (combination-therapy group), methotrexate alone, or placebo for 39 weeks
(double-blind phase). Patients who had qualifying responses at week 39 of the double-blind phase had
all treatment withdrawn at that time and were followed to week 65 (treatment-withdrawal phase). The
primary end point was the proportion of patients with sustained remission in the double-blind phase.
RESULTS: Of 306 patients enrolled, 193 underwent randomization in the double-blind phase; 131
qualified for the treatment-withdrawal phase. More patients in the combination-therapy group than in
the methotrexate-alone group or the placebo group met the criterion for the primary end point (40 of
63 [63%] vs. 26 of 65 [40%] and 15 of 65 [23%], respectively; P=0.009 for combination therapy vs.
methotrexate alone; P<0.001 for combination therapy vs. placebo). At 65 weeks, 28 patients (44%)
who had received combination therapy, 19 (29%) who had received methotrexate alone, and 15 (23%)
who had received placebo were in remission (P=0.10 for combination therapy vs. methotrexate alone;
P=0.02 for combination therapy vs. placebo; P=0.55 for methotrexate alone vs. placebo). No significant
between-group differences were observed in radiographic progression of disease. Serious adverse
events were reported in 3 patients (5%) in the combination-therapy group, 2 (3%) in the methotrexate-
alone group, and 2 (3%) in the placebo group.

CONCLUSIONS: In patients with early rheumatoid arthritis who had a remission while receiving full-
dose etanercept-plus-methotrexate therapy, continuing combination therapy at a reduced dose resulted
in better disease control than switching to methotrexate alone or placebo, but no significant difference
was observed in radiographic progression.

 

 

原文网址:

http://www.nejm.org/doi/full/10.1056/NEJMoa1316133

 

 

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