Doyle Mittie K, Rahman Mahboob U, Han Chenglong, Han John, Giles Jon, Bingham Clifton O, Bathon Joan
Immunology, Clinical Research and Development, Centocor Inc., Malvern, PA 19355, USA.
Semin Arthritis Rheum. 2009 Oct;39(2):123-31. doi: 10.1016/j.semarthrit.2008.08.002. Epub 2008 Sep 27.
To evaluate the effect of antitumor necrosis factor-alpha monoclonal antibody infliximab treatment on anemia in patients with rheumatoid arthritis (RA).
Data from patients with RA who received infliximab or placebo in the multicenter, placebo-controlled, double-blind, randomized ATTRACT, ASPIRE, and START studies were included in this post-hoc, pooled analysis. Infliximab (3 to 10 mg/kg) was administered every 4 or 8 weeks, and all patients received stable doses of methotrexate (MTX). We determined the percentage of anemic patients (baseline hemoglobin level <12 g/dL) who had an increase from baseline in hemoglobin level greater than or equal to 1 or 2 g/dL or achieved normal hemoglobin level at week 22. The association of improvement in anemia with improvement in clinical parameters was also evaluated.
Among patients with anemia at baseline, infliximab plus MTX treatment produced a significantly greater mean (standard deviation) increase in hemoglobin level from baseline to week 22 (0.74 [1.12], P < 0.0001) than placebo plus MTX (0.30 [0.92]). Significantly (P < 0.001) greater proportions of anemic patients treated with infliximab plus MTX had either at least a 1 g/dL (40%) or at least a 2 g/dL (12%) increase in hemoglobin level from baseline to week 22 or achieved normal hemoglobin level (43%) when compared with placebo plus MTX (19, 5, and 28%, respectively). Greater improvement in hemoglobin level among infliximab plus MTX-treated patients was consistently observed across subgroups and in patients without clinical response (American College of Rheumatology 20% response criteria) at week 22. Multiple regression analysis indicated that the effect of infliximab plus MTX on anemia was independent of improvement in disease activity.
Treatment with infliximab plus MTX significantly improved hemoglobin level among anemic RA patients when compared with treatment with placebo plus MTX, even after adjusting for improvement in disease activity.
评估抗肿瘤坏死因子-α单克隆抗体英夫利昔单抗治疗类风湿关节炎（RA）患者贫血的效果。
本事后汇总分析纳入了多中心、安慰剂对照、双盲、随机的ATTRACT、ASPIRE和START研究中接受英夫利昔单抗或安慰剂治疗的RA患者数据。英夫利昔单抗（3至10mg/kg）每4或8周给药一次，所有患者均接受稳定剂量的甲氨蝶呤（MTX）。我们确定了贫血患者（基线血红蛋白水平<12g/dL）中血红蛋白水平较基线升高大于或等于1或2g/dL或在第22周达到正常血红蛋白水平的患者百分比。还评估了贫血改善与临床参数改善之间的关联。
在基线时贫血的患者中，英夫利昔单抗联合MTX治疗从基线到第22周血红蛋白水平的平均（标准差）升高幅度（0.74[1.12]，P<0.0001）显著大于安慰剂联合MTX（0.30[0.92]）。与安慰剂联合MTX（分别为19%、5%和28%）相比，接受英夫利昔单抗联合MTX治疗的贫血患者中，从基线到第22周血红蛋白水平至少升高1g/dL（40%）或至少升高2g/dL（12%）或达到正常血红蛋白水平（43%）的比例显著更高（P<0.001）。在第22周时，在各亚组以及无临床反应（美国风湿病学会20%反应标准）的患者中，始终观察到英夫利昔单抗联合MTX治疗的患者血红蛋白水平改善更大。多元回归分析表明，英夫利昔单抗联合MTX对贫血的影响独立于疾病活动度的改善。
与安慰剂联合MTX治疗相比，英夫利昔单抗联合MTX治疗在调整疾病活动度改善后，仍能显著提高贫血RA患者的血红蛋白水平。
