Inefficacy of infliximab in primary Sjogren's syndrome -: Results of the randomized, controlled trial of Remicade in primary Sjogren's syndrome (TRIPSS)
Inefficacy of infliximab in primary Sjogren's syndrome -: Results of the randomized, controlled trial of Remicade in primary Sjogren's syndrome (TRIPSS)
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DOI：
10.1002/art.20146
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发表时间：
2004-04-01
影响因子：
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通讯作者：
Sibilia, J
中科院分区：
文献类型：
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作者：
Mariette, X;Ravaud, P;Sibilia, J
目标。原发性干燥综合征（SS）没有有效的治疗方法。由于肿瘤坏死因子α (TNFalpha)可能是原发性SS发病的关键因素，我们进行了一项多中心、随机、双盲、安慰剂对照试验，以评估英夫利昔单抗在原发性SS中的作用。共有103例原发性SS患者在第0、2和6周随机分配接受英夫利昔单抗输注（5mg /kg）或安慰剂，随访22周。所有患者都符合新的美欧共识组标准，并且在3个视觉模拟量表（VAS） （0-100 mm）中的2个上以bbb50 mm的值评估活动性疾病，评估关节疼痛，疲劳，口腔，眼部，皮肤，阴道或支气管干燥。良好的总体反应被定义为：从第0周到第10周，3个VAS中2个的评分改善了30%。次要终点分别是每个VAS的值，压痛和肿胀关节的数量，基础唾液流率，泪腺功能的Schirmer试验结果，唇唾液腺活检的焦点评分，c反应蛋白水平，以及在第0,10和22周评估的红细胞沉降率，以及在第0,10和22周使用通用Short Form 36问卷评估的生活质量。在第10周，26.5%的安慰剂组患者和27.8%的英夫利昔单抗组患者有良好的总体反应（P = 0.89），在第22周，20.4%的安慰剂组和16.7%的英夫利昔单抗组有良好的反应（P = 0.62）。此外，在22周的试验中，两组在任何次要终点上都没有差异。英夫利昔单抗组报告的严重不良事件与先前研究中观察到的没有差异。这项随机、双盲、安慰剂对照的抗肿瘤坏死因子研究没有显示英夫利昔单抗对原发性SS有效的任何证据。
Objective. There is no effective treatment for patients with primary Sjogren's syndrome (SS). Since tumor necrosis factor alpha (TNFalpha) could be a key element in the pathogenesis of primary SS, we conducted a multicenter, randomized, double-blind, placebo-controlled trial to evaluate the effect of infliximab in primary SS.Methods. A total of 103 patients with primary SS were randomly assigned to receive infliximab infusions (5 mg/kg) or placebo at weeks 0, 2, and 6 and were followed up for 22 weeks. All patients fulfilled the new American-European Consensus Group criteria for SS and had active disease as assessed by values > 50 mm on 2 of 3 visual analog scales (VAS) (0-100 mm) that evaluated joint pain, fatigue, and buccal, ocular, skin, vaginal, or bronchial dryness. A favorable overall response was defined as the patient having ?30% improvement between weeks 0 and 10 in the values on 2 of the 3 VAS. Secondary end points were values on each VAS separately, the number of tender and swollen joints, the basal salivary flow rate, results of the Schirmer test for lacrimal gland function, the focus score on labial salivary gland biopsy, the level of C-reactive protein, and the erythrocyte sedimentation rate evaluated at weeks 0, 10, and 22, as well as quality of life evaluated by use of the generic Short Form 36 questionnaire administered at weeks 0, 10, and 22.Results. At week 10, 26.5% of patients receiving placebo and 27.8% of patients treated with infliximab had a favorable overall response (P = 0.89), and at week 22, 20.4% of the placebo group and 16.7% of the infliximab group had a favorable response (P = 0.62). In addition, the 2 groups did not differ in any of the secondary end points over the 22 weeks of the trial. Severe adverse events reported in the infliximab group did not differ from those observed in previous studies.Conclusion. This randomized, double-blind, placebo-controlled study of an anti-TNF agent did not show any evidence of efficacy of infliximab in primary SS.