Rosas José, Llinares-Tello Francisca, de la Torre Inmaculada, Santos-Ramírez Carlos, Senabre-Gallego José Miguel, Valor Lara, Barber-Vallés Xavier, Hernández-Flórez Diana, Santos-Soler Gregorio, Salas-Heredia Esteban, Carreño Luis
Department of Rheumatology, Marina Baixa Hospital, Villajoyosa, Alicante, Spain.
Clin Exp Rheumatol. 2014 Nov-Dec;32(6):942-8. Epub 2014 Oct 20.
The aim of this paper is to assess the usefulness of measuring serum levels of adalimumab (ADL) and anti-ADL antibodies in 57 patients with rheumatoid arthritis (RA) treated with ADL for at least 3 months in daily practice.
All patients received concomitant disease-modifying anti-rheumatic drug (DMARD). Receiver-operator characteristics (ROC) analysis was used to obtain the cut-off value of ADL for low disease activity (DAS28-ESR ≤3.2).
Anti-ADL antibodies were detected in 4 (7%) patients with a mean (SD) DAS28 score of 4.6 (0.9). Patients with positive anti-ADL antibodies had significantly lower levels of ADL and higher DAS28 scores than those with negative antibodies. Patients with DAS28 ≤3.2 as compared with patients with DAS28 >3.2 showed significantly better SDAI score, higher serum concentrations of ADL and none of them showed anti-ADL antibodies. The cut-off of serum level of ADL for DAS28 <3.2 was 4.3 mg/L. According to serum levels of ADL, patients were grouped into group 1 (low level) <5.5 mg/L, group 2 (medium level) 5.5-11.3 mg/L and group 3 (high level) >11.3 mg/L. Patients in the medium group were closed to clinical remission (median DAS28 2.7) and patients in the high group were on clinical remission (DAS28 2.1).
Serum levels of ADL should be maintained >4.3 mg/L. In patients with ADL levels >11.3 mg/L, a decrease of the dose of ADL or an increase in the interval between doses may be planned. The presence of anti-ADL antibodies was associated with a loss of clinical efficacy of ADL.
本文旨在评估在日常临床中检测57例接受阿达木单抗（ADL）治疗至少3个月的类风湿关节炎（RA）患者血清中阿达木单抗水平及抗阿达木单抗抗体的作用。
所有患者均同时接受改善病情抗风湿药物（DMARD）治疗。采用受试者工作特征（ROC）分析以获取低疾病活动度（疾病活动度评分28-血沉校正值[DAS28-ESR]≤3.2）时阿达木单抗的临界值。
4例（7%）患者检测到抗阿达木单抗抗体，其平均（标准差）DAS28评分为4.6（0.9）。抗阿达木单抗抗体阳性患者的阿达木单抗水平显著低于抗体阴性患者，且DAS28评分更高。与DAS28>3.2的患者相比，DAS28≤3.2的患者疾病活动指数（SDAI）评分显著更好，血清阿达木单抗浓度更高，且均未检测到抗阿达木单抗抗体。DAS28<3.2时阿达木单抗血清水平的临界值为4.3mg/L。根据阿达木单抗血清水平，患者被分为1组（低水平）<5.5mg/L、2组（中等水平）5.5-11.3mg/L和3组（高水平）>11.3mg/L。中等水平组患者接近临床缓解（DAS28中位数为2.7），高水平组患者处于临床缓解（DAS28为2.1）。
阿达木单抗血清水平应维持>4.3mg/L。对于阿达木单抗水平>11.3mg/L的患者，可考虑减少阿达木单抗剂量或增加给药间隔。抗阿达木单抗抗体的存在与阿达木单抗临床疗效丧失相关。
