Department of Internal Medicine, Rheumatology Clinic, Medical School, University of Ioannina, 45110 Ioannina, Greece.
Joint Bone Spine. 2010 Jul;77(4):325-9. doi: 10.1016/j.jbspin.2010.02.014. Epub 2010 May 8.
To investigate the efficacy, safety and drug discontinuation in patients with ankylosing spondylitis treated with infliximab, as well as the drug survival over a period of 6 years.
Forty patients with ankylosing spondylitis treated with infliximab were included in this open label study. All patients fulfilled the New York revised criteria for ankylosing spondylitis. Infliximab was given intravenously (5 mg/kg/body weight) at weeks 0, 2, 6 and every 8 weeks thereafter for a period of 6 years. Data concerning infliximab efficacy, tolerability, adverse events and drug discontinuation, were recorded. Clinical improvement according to the Bath Ankylosing Spondylitis Disease Activity Index 50% and the Ankylosing Spondylitis Assessment Study Group 20% and 40% were also recorded.
A significant improvement in the Bath Ankylosing Spondylitis Disease Activity Index and Ankylosing Spondylitis Assessment Study Group scores was noted in the first year which sustained through the sixth year of treatment. More specifically, after the sixth year of treatment, Bath Ankylosing Spondylitis Disease Activity Index 50% was achieved by 65% of patients (26/40), Ankylosing Spondylitis Assessment Study Group 20% by 72.5% (29/40) and Ankylosing Spondylitis Assessment Study Group 40% was reached by 70% (28/40) of patients. Clinical improvement was associated with the reduction of acute phase reactants, such as C-reactive protein levels. After the first and the second year of treatment, the survival rate of infliximab reached 95%, after the third year it was 80%, while after the fourth year it was 72.5%, which was maintained throughout the fifth and sixth year of therapy. Five patients were increased the dose of infliximab and three of them had shortened the interval infusion. Overall, 11 patients were withdrawn during the observational period, three because of adverse events, two because of lack of efficacy, while six were lost from follow-up.
Infliximab was effective, safe and well-tolerated in patients with ankylosing spondylitis. The clinical response was maintained for a period of 6 years, with high infliximab survival rate, reaching the percentage of 72.5%.
研究英夫利昔单抗治疗强直性脊柱炎患者的疗效、安全性和停药情况，以及 6 年内的药物存活率。
本开放性标签研究纳入了 40 例接受英夫利昔单抗治疗的强直性脊柱炎患者。所有患者均符合纽约修订的强直性脊柱炎标准。英夫利昔单抗按 5mg/kg/体重静脉给药，在第 0、2、6 周和此后每 8 周给药一次，共 6 年。记录英夫利昔单抗的疗效、耐受性、不良事件和停药情况。还记录了根据 Bath 强直性脊柱炎疾病活动指数 50%和强直性脊柱炎评估研究组 20%和 40%的临床改善情况。
在治疗的第一年就观察到 Bath 强直性脊柱炎疾病活动指数和强直性脊柱炎评估研究组评分的显著改善，这种改善在治疗的第六年仍然持续。更具体地说，在治疗的第六年后，65%（26/40）的患者达到了 Bath 强直性脊柱炎疾病活动指数 50%，72.5%（29/40）的患者达到了强直性脊柱炎评估研究组 20%，70%（28/40）的患者达到了强直性脊柱炎评估研究组 40%。临床改善与急性期反应物（如 C 反应蛋白水平）的降低有关。在治疗的第一和第二年，英夫利昔单抗的生存率达到了 95%，在第三年为 80%，在第四年为 72.5%，并在第五和第六年的治疗中保持不变。有 5 名患者增加了英夫利昔单抗的剂量，有 3 名患者缩短了输液间隔。总的来说，在观察期间有 11 名患者停药，其中 3 名因不良反应，2 名因疗效不佳，6 名因失访。
英夫利昔单抗对强直性脊柱炎患者有效、安全且耐受性良好。临床反应持续了 6 年，英夫利昔单抗的存活率很高，达到 72.5%。
