Huang Feng, Zhang Li-yun, Zhang Jiang-lin, Zhang Feng-chun, Liang Dong-feng, Deng Xiao-hu, Guo Jun-hua, Zhu Jian, Zhao Wei, Li Xiao-feng, Hou Yong
Department of Rheumatology, Chinese PLA General Hospital, Beijing 100853, China.
Zhonghua Nei Ke Za Zhi. 2006 Feb;45(2):122-6.
To evaluate the efficacy and safety profile of a loading regimen of the anti-TNFalpha antibody infliximab in ankylosing spondylitis (AS).
This was an open-labeled trial. Subjects eligible for this study were adults with a diagnosis of definite AS. Active disease was a Bath AS disease activity index (BASDAI) > or = 4 and spinal pain VAS > or = 4. Concurrent stable treatment with nonsteroidal anti-inflammatory drugs was permitted during the study. Subjects were not permitted to be on methotrexate, systemic corticosteroids, cytotoxic drugs or disease-modifying anti-rheumatic drugs for various time periods before screening. Infliximab 5 mg/kg was infused at weeks 0, 2, 6. All patients were followed up to 10 weeks. The primary endpoint was proportion of ASAS 20 responders at week 10. The secondary endpoints were the proportion of subjects achieving an ASAS partial remission, the change from baseline in bath AS functional index and in the physical component summary score of the short form-36 in health survey questionnaire at week 10. Other secondary endpoints, related to reducing signs and symptoms of AS and improving range of motion and physical function, were evaluated.
63 patients (79% males, 90% HLA-B(27)(+), median age 32 yr, median disease duration 10 yr) completed the treatment. The proportion of ASAS 20 responders at 2, 6, 10 week was 75%, 84%, 84% respectively. The proportion of ASAS partial remission patients at 2, 6, 10 week was 10%, 21%, 30% respectively. Results for other secondary efficacy endpoints showed that infliximab could provide substantial benefits to patients with AS by reducing clinical signs and symptoms and improving range of motion, physical function, and quality of life. Sixty-five percent of subjects reported treatment-related adverse events. The most frequently occurred were upper respiratory tract infection and skin and appendages. Secondary was elevation of liver enzymes. Most treatment-related adverse events were mild to moderate in severity. Two patients had serious dermatitis and one stopped treatment owing to an infusion reaction. Short-term follow up indicated that effect of Remicade lasted for about 2 to 8 months without any new side effect.
A loading regimen of infliximab demonstrated consistent evidence of efficacy and was well tolerated in the treatment of active AS.
评估抗TNFα抗体英夫利昔单抗负荷给药方案治疗强直性脊柱炎（AS）的疗效和安全性。
这是一项开放标签试验。符合本研究条件的受试者为确诊AS的成年人。疾病活动期定义为巴斯强直性脊柱炎疾病活动指数（BASDAI）≥4且脊柱疼痛视觉模拟评分（VAS）≥4。研究期间允许同时使用非甾体抗炎药进行稳定治疗。在筛查前的不同时间段内，受试者不得使用甲氨蝶呤、全身性皮质类固醇、细胞毒性药物或改善病情的抗风湿药物。在第0、2、6周静脉输注英夫利昔单抗5mg/kg。所有患者随访至10周。主要终点是第10周达到ASAS 20反应标准的患者比例。次要终点包括达到ASAS部分缓解的受试者比例、第10周时巴斯强直性脊柱炎功能指数相对于基线的变化以及健康调查简表36项（SF-36）中身体成分总结评分相对于基线的变化。还评估了与减轻AS体征和症状以及改善关节活动范围和身体功能相关的其他次要终点。
63例患者（79%为男性，90% HLA-B27阳性，中位年龄32岁，中位病程10年）完成治疗。第2、6、10周时达到ASAS 20反应标准的患者比例分别为75%、84%、84%。第2、6、10周时达到ASAS部分缓解的患者比例分别为10%、21%、30%。其他次要疗效终点结果显示，英夫利昔单抗可通过减轻临床体征和症状、改善关节活动范围、身体功能和生活质量，为AS患者带来显著益处。65%的受试者报告了与治疗相关的不良事件。最常见的是上呼吸道感染以及皮肤和附属器问题。其次是肝酶升高。大多数与治疗相关的不良事件为轻至中度。2例患者出现严重皮炎，1例因输液反应停止治疗。短期随访表明，类克的疗效持续约2至8个月，且无任何新的副作用。
英夫利昔单抗负荷给药方案在治疗活动性AS方面显示出一致的疗效证据，且耐受性良好。
