An open-label trial on the safety of recombinant human tumor necrosis factor-Fc treatment in Chinese rheumatic diseases patients / 中华风湿病学杂志

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.