英夫利昔单抗治疗强直性脊柱炎：一项观察性研究。
Infliximab treatment in ankylosing spondylitis: an observational study.
作者信息
Nikas S N, Alamanos Y, Voulgari P V, Pliakou X I, Papadopoulos C G, Drosos A A
机构信息
Rheumatology Clinic, Department of Internal Medicine, University of Ioannina Medical School, 45110 Ioannina, Greece.
出版信息
Ann Rheum Dis. 2005 Jun;64(6):940-2. doi: 10.1136/ard.2004.029900. Epub 2004 Nov 25.
OBJECTIVE
To investigate efficacy, toxicity, and drug discontinuation in patients with ankylosing spondylitis (AS) treated with infliximab.
METHODS
35 patients with AS with mean (SD) age 42.5 (12.6) years and mean (SD) disease duration 14.5 (8.0) years were studied for 2 years. Patients entering the study had a negative tuberculin skin test, were fully informed about the treatment, and were followed up regularly. Infliximab, 5 mg/kg weight, was given intravenously at weeks 0, 2, 6, and every 8 weeks thereafter. Data concerning infliximab tolerability, adverse events, interval, and drug discontinuation were all recorded. Clinical improvement according to the BASDAI and the Ankylosing Spondylitis Assessment Study group (ASAS) 20%, 40%, and ASAS 5/6 response criteria were recorded.
RESULTS
After 1 year, 20 (57%) patients achieved the BASDAI 50% response criteria, 25 (71%) achieved ASAS 20%, 23 (66%) reached ASAS 40%, and 18 (51%) attained ASAS 5/6. After 2 years' treatment, 11 (31%) patients achieved BASDAI 50% response criteria, 14 (40%) ASAS 20%, 11 (31%) ASAS 40%, and 9 (26%) ASAS 5/6. Clinical improvement was associated with an improved BASFI and reduction of CRP. After 2 years' treatment, "infliximab survival" was 89%. Treatment was well tolerated and adverse events were mild; 3 patients discontinued the study.
CONCLUSION
Infliximab was effective, safe, and well tolerated in patients with AS.
目的
研究英夫利昔单抗治疗强直性脊柱炎（AS）患者的疗效、毒性及停药情况。
方法
对35例AS患者进行了为期2年的研究，患者平均（标准差）年龄42.5（12.6）岁，平均（标准差）病程14.5（8.0）年。进入研究的患者结核菌素皮肤试验阴性，充分了解治疗情况，并定期随访。英夫利昔单抗按体重5 mg/kg，于第0、2、6周静脉给药，此后每8周给药一次。记录有关英夫利昔单抗耐受性、不良事件、给药间隔及停药的数据。根据巴斯强直性脊柱炎疾病活动指数（BASDAI）以及强直性脊柱炎评估研究组（ASAS）20%、40%反应标准和ASAS 5/6反应标准记录临床改善情况。
结果
1年后，20例（57%）患者达到BASDAI 50%反应标准，25例（71%）达到ASAS 20%，23例（66%）达到ASAS 40%，18例（51%）达到ASAS 5/6。经过2年治疗，11例（31%）患者达到BASDAI 50%反应标准，14例（40%）达到ASAS 20%，11例（31%）达到ASAS 40%，9例（26%）达到ASAS 5/6。临床改善与BASFI改善及CRP降低相关。经过2年治疗，“英夫利昔单抗留存率”为89%。治疗耐受性良好，不良事件轻微；3例患者退出研究。
结论
英夫利昔单抗治疗AS患者有效、安全且耐受性良好。
Zotero 插件