Assous Noémie, Gossec Laure, Dieudé Phillippe, Meyer Olivier, Dougados Maxime, Kahan Andre, Allanore Yannick
Department of Rheumatology A and Rheumatology B, Paris Descartes University, Medical Faculty, Cochin Hospital, AP-HP, Paris, France.
J Rheumatol. 2008 Jan;35(1):31-4. Epub 2007 Nov 15.
Rituximab has been shown to be effective in refractory rheumatoid arthritis (RA) in randomized controlled trials, allowing approval by health agencies. Our aim was to assess in routine care the effects of rituximab in patients with RA who had experienced an inadequate response to anti-tumor necrosis factor-alpha (TNF-alpha) agents or had a contraindication to these drugs.
An observational retrospective study was conducted. Rituximab (1000 mg intravenous infusion on Days 1 and 15) was administered with concomitant methotrexate therapy. Responses defined according to the European League Against Rheumatism (EULAR criteria) were assessed at Week 24.
Fifty patients were included: 30 had inadequate response to anti-TNF-alpha and 20 had contraindication to anti-TNF-a drugs. EULAR response was observed in 82%, good response in 36% (including remission in 12%), moderate response in 46%, and no response in 18%. One infusion-related reaction and 2 pulmonary infections occurred. Eleven of the 50 patients (22%) experienced flare and received retreatment with rituximab at 6 months. Thirty additional patients had flare after 6 months and the median delay for retreatment among the 41 responders was 9 (range 6 24) months. No difference regarding efficacy or tolerance of rituximab was observed according to previous inadequate response or contraindication to anti-TNF.
A single cycle of rituximab, in combination with continued methotrexate, provided significant improvement in disease activity at Week 24, with good tolerance, in patients with severe and active RA despite anti-TNF-alpha agents and/or with contraindication to these drugs, in this daily practice study.
在随机对照试验中，利妥昔单抗已被证明对难治性类风湿关节炎（RA）有效，从而获得了卫生机构的批准。我们的目的是在常规护理中评估利妥昔单抗对那些对抗肿瘤坏死因子-α（TNF-α）药物反应不佳或对这些药物有禁忌证的RA患者的疗效。
进行了一项观察性回顾性研究。利妥昔单抗（第1天和第15天静脉输注1000mg）与甲氨蝶呤联合治疗。根据欧洲抗风湿病联盟（EULAR标准）定义的反应在第24周进行评估。
纳入50例患者：30例对抗TNF-α反应不佳，20例对抗TNF-α药物有禁忌证。观察到EULAR反应的患者占82%，良好反应的患者占36%（包括缓解患者占12%），中度反应的患者占46%，无反应的患者占18%。发生了1例输液相关反应和2例肺部感染。50例患者中有11例（22%）出现病情复发，并在6个月时接受了利妥昔单抗再次治疗。另外30例患者在6个月后出现病情复发，41例有反应患者再次治疗的中位延迟时间为9（范围6～24）个月。根据既往对抗TNF-α反应不佳或禁忌情况，未观察到利妥昔单抗在疗效或耐受性方面的差异。
在这项日常实践研究中，对于尽管使用了TNF-α药物和/或对这些药物有禁忌证但仍患有严重活动性RA的患者，单周期利妥昔单抗联合持续使用甲氨蝶呤在第24周时可显著改善疾病活动度，且耐受性良好。
