An open-label trial on the safety of recombinant human tumor necrosis factor-Fc treatment in Chinese rheumatic diseases patients
10.3760/cma.j.issn.1007-7480.2011.12.014
- VernacularTitle:重组人Ⅱ型肿瘤坏死因子受体-抗体融合蛋白联合改善病情抗风湿药治疗中国人群风湿性疾病的安全性研究
- Author:
Fang DU
;
Chun-de BAO
;
Feng-chun ZHANG
- Publication Type:Journal Article
- Keywords:
Arthritis,rheumatoid;
Spondylitis,ankylosing;
Tumor necrosis factor-alpha
- From:
Chinese Journal of Rheumatology
2011;15(12):850-854
- CountryChina
- Language:Chinese
-
Abstract:
Objective To compare the safety of recombinant human tumor necrosis factor-Fc (rhTNFR:Fc) and other DMARDs,in patients with rheumatoid arthritis (RA),ankylosing spondylitis (AS),juvenile idiopathetic arthritis (JIA) or psoriatic arthritis (PsA).Methods Patients who received rhTNFR:Fc 25 mg twice weekly from May 2006 to March 2009 were involved in this open-lable study.Safety assessments were carried out at regular intervals.Results Of the 2014 patients enrolled in the open-label trial,1388,421 and 232 were RA,AS or other diseases,such as JIA and P.sA respectively.Frequent adverse events included injection-site reactions (2.67％),rash (1.87％) and hyperamino transferase (1.80％) in RA patients.Similarly,injection-site reactions (5.23％),hyperaminotransferase (2.38％) and rash (0.71％) were frequent in AS patients.Upper respiratory infection was most frequent among infectious adverse events.There were no reports of patients with serious adverse events,dead case,TB infection and malignancies.Conclusion rhTNFR:Fc has shown a favourable safety profile in Chinese rheumatic disease patients.
