Abstract: Objective To investigate the efficacy and tolerability of a recombinant human tumor necrosis factor:Fc fusion protein (rhTNFR:Fc,with a trade name of Yisaipu) in the treatment of moderate to severe psoriasis vulgaris.Methods A multicentre,randomized,double blind,and parallel-controlled trial was performed.One hundred and forty-four patients with moderate to severe psoriasis vulgaris from four centres were randomly assigned and treated with either once-weekly subcutaneous injection of rhTNFR:Fc (50 mg) or oral methotrexate (MTX)(7.5 mg) for 12 weeks.Patients were followed up at 2,4,8,12 weeks after the treatment.Results One hundred and twenty-four patients finished the 12-week course of treatment.At 12 weeks after the treatment,a 50%,75%,90% improvement in psoriasis area and severity index (PASI) was achieved by 86.11%,76.39%,52.78% respectively of rhTNFR:Fc-treated patients,and by 63.89%,44.44%,22.22% respectively in MTX-treated patients,and all the three improvement rates were of significant difference between the two groups of patients (all P<0.01).Physician global assessment (PGA), dermatology life quality index (DLQI) and 10-cm visual analog scale (VAS) all reduced more significantly, and more patients were cured or approximately cured in rhTNFR:Fc-treated patients than in MTX-treated patients (all P<0.05).Adverse reactions,mainly including decrease of leucocytes or neutrophils,infection, dysfunction of liver,edema and pruritus at the injection site,etc,occurred in 26.39% of rhTNFR:Fc-treated patients and 29.17% of MTX-treated patients (P>0.05).Conclusion Compared with MTX,rhTNFR:Fc acts more quickly with a higher cure rate and less toxic reactions in the treatment of psoriasis vulgaris.

Key words: Psoriasis, Controlled clinical trials, Methotrexate, rhTNFR:Fc