ten Wolde S, Breedveld F C, Hermans J, Vandenbroucke J P, van de Laar M A, Markusse H M, Janssen M, van den Brink H R, Dijkmans B A
Department of Rheumatology, University Hospital Leiden, Netherlands.
Lancet. 1996 Feb 10;347(8998):347-52. doi: 10.1016/s0140-6736(96)90535-8.
A favourable benefit/risk ratio for treatment of rheumatoid arthritis (RA) with second-line drugs has been established only in short-term studies. The present investigation addresses the question of whether RA patients with a good response to long-term treatment with second-line drugs benefit from continuation of such treatment.
A 52-week randomised double-blind placebo-controlled multicentre study was conducted to assess the effect of stopping second-line therapy in 285 RA patients with a good long-term therapeutic response. The patients either continued the second-line drug (n = 142) or received a placebo (n = 143). The endpoint was a flare, defined as recurrence of synovitis.
At entry into the study median duration of second-line drug therapy was 5 years (range 2-33). At 52 weeks the cumulative incidence of a flare was 38% for the placebo group and 22% for the continued therapy group (p = 0.002). The risk of a flare was 2.0 times higher for patients receiving placebo than for those continuing the second-line drug (95% CI 1.27 to 3.17). The same trend was found for each second-line drug separately, with the exception of d-penicillamine. Side-effects that necessitated dose reduction or discontinuation occurred in 2 patients in each group.
Second-line drugs continue to be effective in RA patients who have responded well to initial treatment.
二线药物治疗类风湿关节炎（RA）的获益/风险比仅在短期研究中得到证实。本研究旨在探讨对二线药物长期治疗反应良好的RA患者继续此类治疗是否有益。
开展了一项为期52周的随机双盲安慰剂对照多中心研究，以评估在285例对长期治疗反应良好的RA患者中停用二线治疗的效果。患者要么继续使用二线药物（n = 142），要么接受安慰剂（n = 143）。终点为病情复发，定义为滑膜炎复发。
研究入组时二线药物治疗的中位持续时间为5年（范围2 - 33年）。52周时，安慰剂组病情复发的累积发生率为38%，继续治疗组为22%（p = 0.002）接受安慰剂的患者病情复发风险比继续使用二线药物的患者高2.0倍（95%可信区间1.27至3.17）。除青霉胺外，每种二线药物单独使用时均发现相同趋势。每组各有2例患者出现需要减少剂量或停药的副作用。
二线药物对初始治疗反应良好的RA患者继续有效。
