英夫利昔单抗治疗强直性脊柱炎患者：一项为期12个月的开放标签研究。
Infliximab therapy in patients with ankylosing spondylitis: an open label 12 month study.
作者信息
Temekonidis T I, Alamanos Y, Nikas S N, Bougias D V, Georgiadis A N, Voulgari P V, Drosos A A
机构信息
Division of Rheumatology, Department of Internal Medicine, Medical School, University of Ioannina, Ioannina, Greece.
出版信息
Ann Rheum Dis. 2003 Dec;62(12):1218-20. doi: 10.1136/ard.2003.014258.
OBJECTIVE
To evaluate the efficacy and safety of long term infliximab therapy in patients with severe refractory ankylosing spondylitis (AS).
PATIENTS AND METHODS
Twenty five patients (24 male, 1 female; mean (SD) age 36.0 (10.5); disease duration 13.8 (8.5) years) with AS fulfilling the modified New York criteria for AS were investigated. Twenty two (88%) patients were HLA-B27 positive. All patients had active axial disease (Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) >/=30/100) and C reactive protein (CRP) >/=10 mg/l, despite adequate treatment. Intravenous infliximab (5 mg/kg) was given at weeks 0, 2, 6, and every eight weeks thereafter for 12 months. The primary end point was the reduction of the patient's global assessment of pain (GAP) by >20% on a 100 mm visual analogue scale.
RESULTS
GAP was reduced by >20% in 23 (92%) patients, by 50% in 21 (84%) patients, and by 70% in 13 (52%). The change in BASDAI and CRP from baseline was statistically significant. The treatment was well tolerated with minimal side effects. One patient dropped out owing to inefficacy and one stopped treatment owing to an allergic reaction.
CONCLUSION
This longer length study confirms the efficacy of infliximab and the good safety profile in patients with AS.
目的
评估英夫利昔单抗长期治疗重度难治性强直性脊柱炎（AS）患者的疗效和安全性。
患者与方法
对25例符合修订的纽约AS标准的AS患者（24例男性，1例女性；平均（标准差）年龄36.0（10.5）岁；病程13.8（8.5）年）进行研究。22例（88%）患者HLA - B27阳性。尽管接受了充分治疗，但所有患者均有活动性中轴疾病（巴斯强直性脊柱炎疾病活动指数（BASDAI）≥30/100）且C反应蛋白（CRP）≥10mg/L。在第0、2、6周静脉注射英夫利昔单抗（5mg/kg），此后每8周注射一次，共12个月。主要终点是患者在100mm视觉模拟量表上对疼痛的整体评估（GAP）降低>20%。
结果
23例（92%）患者的GAP降低>20%，21例（84%）患者降低50%，13例（52%）患者降低70%。BASDAI和CRP相对于基线的变化具有统计学意义。治疗耐受性良好，副作用最小。1例患者因无效退出，1例因过敏反应停止治疗。
结论
这项更长时间的研究证实了英夫利昔单抗对AS患者的疗效和良好的安全性。
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