Visvanathan Sudha, Wagner Carrie, Smolen Josef, St Clair E William, Hegedus Ron, Baker Daniel, Keenan Gregory
Centocor, Inc., Malvern, Pennsylvania 19355, USA.
Arthritis Rheum. 2006 Sep;54(9):2840-4. doi: 10.1002/art.22054.
To assess the occurrence of anticardiolipin antibodies (aCL) in patients with early rheumatoid arthritis (RA) receiving treatment with infliximab plus methotrexate (MTX) versus MTX alone.
The first 299 patients enrolled in the randomized, Active-Controlled Study of Patients Receiving Infliximab for the Treatment of Rheumatoid Arthritis of Early Onset (ASPIRE) trial who had baseline (week 0) samples available for aCL testing were included in this study. Sera were collected at weeks 0, 30, and 54 from 110 patients taking infliximab 3 mg/kg plus MTX, 98 patients taking infliximab 6 mg/kg plus MTX, and 91 patients taking placebo plus MTX. IgG and IgM aCL were measured using an anticardiolipin assay.
IgG and IgM aCL positivity at baseline was similar in all treatment groups. Most patients were negative for IgG aCL at baseline and remained so at the last followup evaluation. One percent (2 of 208) of patients who received infliximab plus MTX and were negative for IgG aCL at baseline were positive for IgG aCL at weeks 30 and 54. A slightly higher proportion of patients who received infliximab plus MTX and were negative for IgM aCL at baseline were positive for IgM aCL at weeks 30 and 54 (4.8% [10 of 208]) as compared with patients who received placebo plus MTX (1.1% [1 of 91]), but the difference was not significant.
There was a low incidence of the development of aCL in patients with early RA who received infliximab in combination with MTX, and the difference was not significant compared with patients who received placebo plus MTX.
评估早期类风湿关节炎（RA）患者接受英夫利昔单抗联合甲氨蝶呤（MTX）治疗与单独接受MTX治疗时抗心磷脂抗体（aCL）的出现情况。
纳入早期类风湿关节炎英夫利昔单抗治疗活性对照研究（ASPIRE）试验中最初入组的299例患者，这些患者有基线（第0周）样本可用于aCL检测。在第0周、30周和54周收集了110例接受3mg/kg英夫利昔单抗联合MTX治疗的患者、98例接受6mg/kg英夫利昔单抗联合MTX治疗的患者以及91例接受安慰剂联合MTX治疗的患者的血清。使用抗心磷脂检测法测量IgG和IgM aCL。
所有治疗组在基线时IgG和IgM aCL阳性率相似。大多数患者在基线时IgG aCL为阴性，在最后一次随访评估时仍为阴性。基线时IgG aCL阴性且接受英夫利昔单抗联合MTX治疗的患者中，有1%（208例中的2例）在第30周和54周时IgG aCL转为阳性。与接受安慰剂联合MTX治疗的患者（1.1%[91例中的1例]）相比，基线时IgM aCL阴性且接受英夫利昔单抗联合MTX治疗的患者中，在第30周和54周时IgM aCL转为阳性的比例略高（4.8%[208例中的10例]），但差异无统计学意义。
早期RA患者接受英夫利昔单抗联合MTX治疗时aCL产生的发生率较低，与接受安慰剂联合MTX治疗的患者相比差异无统计学意义。
