Elliott M J, Maini R N, Feldmann M, Long-Fox A, Charles P, Katsikis P, Brennan F M, Walker J, Bijl H, Ghrayeb J
Clinical Immunology Division, Kennedy Institute of Rheumatology, London, United Kingdom.
Arthritis Rheum. 1993 Dec;36(12):1681-90. doi: 10.1002/art.1780361206.
To evaluate the safety and efficacy of a chimeric monoclonal antibody to tumor necrosis factor alpha (TNF alpha) in the treatment of patients with rheumatoid arthritis (RA).
Twenty patients with active RA were treated with 20 mg/kg of anti-TNF alpha in an open phase I/II trial lasting 8 weeks.
The treatment was well tolerated, with no serious adverse events. Significant improvements were seen in the Ritchie Articular Index, which fell from a median of 28 at study entry to a median of 6 by week 6 (P < 0.001), the swollen joint count, which fell from 18 to 5 (P < 0.001) over the same period, and in the other major clinical assessments. Serum C-reactive protein levels fell from a median of 39.5 mg/liter at study entry to 8 mg/liter at week 6 (P < 0.001), and significant decreases were also seen in serum amyloid A and interleukin-6 levels.
Treatment with anti-TNF alpha was safe and well tolerated and resulted in significant clinical and laboratory improvements. These preliminary results support the hypothesis that TNF alpha is an important regulator in RA, and suggest that it may be a useful new therapeutic target in this disease.
评估一种肿瘤坏死因子α（TNFα）嵌合单克隆抗体治疗类风湿关节炎（RA）患者的安全性和有效性。
在一项为期8周的开放I/II期试验中，20例活动期RA患者接受20mg/kg抗TNFα治疗。
治疗耐受性良好，未出现严重不良事件。里奇关节指数有显著改善，从研究开始时的中位数28降至第6周时的中位数6（P<0.001）；同期肿胀关节计数从18个降至5个（P<0.001），其他主要临床评估指标也有改善。血清C反应蛋白水平从研究开始时的中位数39.5mg/升降至第6周时的8mg/升（P<0.001），血清淀粉样蛋白A和白细胞介素-6水平也显著下降。
抗TNFα治疗安全且耐受性良好，并导致临床和实验室指标显著改善。这些初步结果支持TNFα是RA重要调节因子的假说，并表明它可能是该疾病一个有用的新治疗靶点。
