Université François Rabelais de Tours, Centre National de la Recherche Scientifique UMR 6239 Génétique Immunothérapie Chimie et Cancer, Tours, France.
Ther Drug Monit. 2011 Aug;33(4):411-6. doi: 10.1097/FTD.0b013e318224f83d.
Infliximab is a chimeric monoclonal antibody that binds to human tumor necrosis factor alpha and which is approved for refractory spondyloarthritis (SpA). Individual adjustment of infliximab dosage may help to improve the therapeutic response in SpA. We investigated whether a knowledge of infliximab serum concentration modifies physician decision and improves the control of disease activity in SpA.
Thirty-two patients routinely treated with infliximab were included in an observational open-label study. On visit 1 (V1), according to disease activity, a preliminary therapeutic decision was selected among 4 therapeutic options (ie, decrease, increase, maintain the dosage of infliximab, or switch over for another treatment), and a blood sample was collected to measure infliximab trough serum concentration. The final therapeutic decision, based on both disease activity and infliximab serum concentration assessed at V1, was applied at the following infusion (V2). Clinical and biological evaluations were performed at V3 and V4 and compared with those at V1.
The measurement of infliximab trough concentration modified the therapeutic decision for 10 patients (31%). For both patients with increased or decreased infliximab dosage at V2, median Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) was similar at V3 or V4 as compared with that at V1. However, a trend for an inverse relationship between infliximab serum concentrations and BASDAI was observed.
Knowledge of infliximab trough concentration modified the therapeutic decision for SpA patients with predominantly axial symptoms but did not improve the control of disease activity as estimated by the BASDAI.
英夫利昔单抗是一种嵌合型单克隆抗体，可与人肿瘤坏死因子-α结合，已被批准用于治疗难治性脊柱关节炎（SpA）。英夫利昔单抗剂量的个体化调整可能有助于改善 SpA 的治疗反应。我们研究了英夫利昔单抗血清浓度的知识是否会改变医生的决策，并改善 SpA 疾病活动的控制。
32 例常规接受英夫利昔单抗治疗的患者纳入一项观察性、开放性标签研究。在第 1 次就诊（V1）时，根据疾病活动度，在 4 种治疗选择（即减少、增加、维持英夫利昔单抗剂量或更换另一种治疗）中选择初步治疗决策，并采集血样测量英夫利昔单抗谷浓度。根据 V1 时评估的疾病活动度和英夫利昔单抗血清浓度，在随后的输注（V2）时做出最终治疗决策。在 V3 和 V4 时进行临床和生物学评估，并与 V1 时进行比较。
英夫利昔单抗谷浓度的测量改变了 10 例患者（31%）的治疗决策。对于 V2 时增加或减少英夫利昔单抗剂量的患者，Bath 强直性脊柱炎疾病活动指数（BASDAI）的中位数在 V3 或 V4 时与 V1 时相似。然而，观察到英夫利昔单抗血清浓度与 BASDAI 之间存在反向关系的趋势。
英夫利昔单抗谷浓度的知识改变了主要表现为轴性症状的 SpA 患者的治疗决策，但并未如 BASDAI 所估计的那样改善疾病活动的控制。
