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低剂量英夫利昔单抗对大多数脊柱关节病患者来说并不足够。

Low dose of infliximab is inadequate in most patients with spondylarthropathies.

作者信息

Sidiropoulos P, Kritikos H D, Siakka P, Mamoulaki M, Kouroumali H, Voudouris K, Boumpas D T

机构信息

University Hospital, Medical School, University of Crete, Heraklio, Greece.

出版信息

Clin Exp Rheumatol. 2005 Jul-Aug;23(4):513-6.

Abstract

OBJECTIVES

The recommended starting dose for infliximab for ankylosing spondylitis 5mg/kg is higher than that for rheumatoid arthritis. Because of the high expense of the drug lower doses may be considered. We report our experience with lower initial doses.

METHODS

Thirty patients with active SpA (16 psoriatic arthritis, 12 ankylosing spondylitis and 2 undifferentiated) received 6 infliximab infusions. Patients had substantial axial disease (mean BASDAI at baseline 5.5). Concomitant therapy (methotrexate or prednisolone) remained stable throughout treatment period. The mean initial dose of infliximab was 3.5 mg/kg/infusion. Clinical efficacy was assessed by BASDAI. The criterion for dose adjustment was a BASDAI improvement of less than 50%. The primary end-points were the proportion of patients requiring a dose adjustment and the percentage of patients achieving 50% improvement in BASDAI after 6 infusions.

RESULTS

In this cohort, 2 patients discontinued therapy, 1 for pulmonary infection and 1 for allergic reaction. Twelve patients (40%) showed 50% improvement in BASDAI between baseline and prior to the 7th infusion, while 15 patients (50%) had an improvement > 2 points. To achieve clinical response the frequency and/or the dose of infliximab infusions were increased in 63% of patients. The mean infliximab dose increased from 3.5 mg/kg at the first infusion to 4.3 mg/kg (p < 0.001) at the 7th infusion, resulting in a cumulative dose at the end of the study period comparable to the recommended one.

CONCLUSIONS

In the majority of our SpA patients low starting doses of infliximab required subsequent adjustment. In these patients infliximab should be administered at the recommended dose of 5mg/kg/infusion.

摘要

目的

英夫利昔单抗用于强直性脊柱炎的推荐起始剂量为5mg/kg,高于类风湿关节炎的推荐起始剂量。由于该药物费用高昂,可考虑使用较低剂量。我们报告了使用较低初始剂量的经验。

方法

30例活动性脊柱关节炎患者(16例银屑病关节炎、12例强直性脊柱炎和2例未分化型)接受了6次英夫利昔单抗输注。患者存在明显的中轴疾病(基线时平均BASDAI为5.5)。在整个治疗期间,联合治疗(甲氨蝶呤或泼尼松龙)保持稳定。英夫利昔单抗的平均初始剂量为3.5mg/kg/次输注。通过BASDAI评估临床疗效。剂量调整的标准是BASDAI改善小于50%。主要终点是需要调整剂量的患者比例以及6次输注后BASDAI改善50%的患者百分比。

结果

在该队列中,2例患者停止治疗,1例因肺部感染,1例因过敏反应。12例患者(40%)在基线至第7次输注前BASDAI改善50%,而15例患者(50%)改善超过2分。为达到临床反应,63%的患者增加了英夫利昔单抗输注的频率和/或剂量。英夫利昔单抗的平均剂量从第一次输注时的3.5mg/kg增加到第7次输注时的4.3mg/kg(p<0.001),导致研究期末的累积剂量与推荐剂量相当。

结论

在我们的大多数脊柱关节炎患者中,英夫利昔单抗低起始剂量需要后续调整。对于这些患者,应按推荐剂量5mg/kg/次输注英夫利昔单抗。

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