La Paz University Hospital, Department of Rheumatology, Castellana 261, Madrid 28046, Spain.
Ann Rheum Dis. 2012 Dec;71(12):1955-60. doi: 10.1136/annrheumdis-2011-200828. Epub 2012 May 6.
Infliximab (IFX) is a monoclonal antibody against tumour necrosis factor α that is effective for treating spondyloarthritis (SpA). However, after initial success of the drug some patients lose responsiveness or develop infusion reactions, which may be related to the development of antibodies against the drug.
To investigate the clinical relevance of antibodies to infliximab (ATI) formation in patients with SpA undergoing IFX treatment over a prolonged period.
94 patients with SpA treated with IFX from 1999 to 2010 were studied. Their clinical characteristics, serum trough IFX levels and ATI status were evaluated for a mean of 6.99 (95% CI:6.28 to 7.7) years. Clinical activity and improvement were measured using the Ankylosing Spondylitis Disease Activity Score (ASDAS): inactive <1.3, moderate ≥1.3 and <2.1, high ≥2.1-≤3.5, and very high >3.5 at three time points (6 months, 12 months and >4 years).
ATI were detected in 24 (25.5%) patients. The patients with ATI had higher ASDAS scores than those without ATI (2.55±0.89 vs 1.79±1.04, p=0.038 at 6 months; 1.95±0.67 vs 1.67±0.71, p=0.042 at 1 year; 2.52±0.99 vs 1.53±0.81, p=0.024 at >4 years). Eleven patients (12%) developed infusion-related reactions, and of these, ATI were present in eight patients (73%). The patients with infusion-related reactions had higher ATI titres (median 12 931 AU/ml, IQR 853-82 437) vs median 2454 AU/ml, IQR 449-7718, p=0.028) and shorter survival (4.25 years vs 8.19 years, p<0.001). ATI development occurred more frequently in the patients not receiving methotrexate (20/58 (34.5%) vs 4/36 (11.1%), p=0.011).
In patients with SpA treated with IFX, ATI formation is associated with a poor clinical response, the appearance of infusion reactions and the discontinuation of treatment.
英夫利昔单抗（IFX）是一种针对肿瘤坏死因子-α的单克隆抗体，对治疗脊柱关节炎（SpA）有效。然而，在药物最初成功应用后，一些患者会失去反应性或出现输注反应，这可能与药物抗体的产生有关。
研究接受英夫利昔单抗（IFX）治疗的 SpA 患者在较长时间内形成针对 IFX 的抗体（ATI）的临床相关性。
研究了 1999 年至 2010 年间接受 IFX 治疗的 94 例 SpA 患者。对他们的临床特征、血清 IFX 谷值水平和 ATI 状态进行评估，平均随访 6.99 年（95%CI：6.28 至 7.7）。采用强直性脊柱炎疾病活动度评分（ASDAS）评估临床活动度和改善情况：无活动度＜1.3、中度≥1.3 且＜2.1、高度≥2.1-≤3.5、极高＞3.5，分别在 3 个时间点（6 个月、12 个月和＞4 年）进行评估。
24 例（25.5%）患者检测到 ATI。与无 ATI 的患者相比，ATI 阳性患者的 ASDAS 评分更高（6 个月时为 2.55±0.89 比 1.79±1.04，p=0.038；12 个月时为 1.95±0.67 比 1.67±0.71，p=0.042；＞4 年时为 2.52±0.99 比 1.53±0.81，p=0.024）。11 例（12%）患者出现与输注相关的反应，其中 8 例（73%）患者存在 ATI。出现与输注相关反应的患者 ATI 滴度更高（中位数 12931 AU/ml，IQR 853-82437）比中位数 2454 AU/ml，IQR 449-7718，p=0.028），且生存时间更短（4.25 年比 8.19 年，p＜0.001）。在未接受甲氨蝶呤治疗的患者中，ATI 发生更频繁（58 例中有 20 例[34.5%]比 36 例中有 4 例[11.1%]，p=0.011）。
在接受 IFX 治疗的 SpA 患者中，ATI 形成与临床反应不佳、输注反应出现和治疗中止有关。
