Han 2007.
Methods | Randomised, double‐blind, active‐controlled trial Date: not stated Location: China |
Participants | No statement except a total number of participants (n = 144) |
Interventions |
Intervention Recombinant human tumour necrosis factor receptor (50 mg/week) Control intervention Methotrexate (7.5 mg/week) |
Outcomes |
At 12 weeks Proportion of PASI 50, PASI 75, PASI 90 |
Notes |
Abstract in Journal of Clinical Dermatology 2007 (730‐2) HAN Ling, FANG Xu, HUANG Qiong, YANG Qin‐ping, FU Wen‐wen, ZHENG Zhi‐zhong, GU Jun, SUN Jiao‐fang, XU Ai‐e (Department of Dermatology,Huashan Hospital, Fudan University, Shanghai 200040, China) Objective: To evaluate the effect of recombinant human tumour necrosis factor receptor (rhTNFR:Fc) in the treatment of moderate to severe plaque psoriasis on psoriasis area and severity index (PASI). Methods: Using randomised, double‐blind and double‐simulated, parallel‐controlled with positive drug, multicenter, clinical trial was employed to investigate 144 cases of patients with moderate to severe plaque psoriasis, of which there were 72 cases in both trial group and the control group respectively, to evaluate the effect on PASI. Results: 124 cases of patients had accomplished the 12‐week clinical trial. After 12 weeks the rate of PASI50, PASI75, PASI90 were significantly higher than those of the control group (P < 0.01). The therapeutic effects on trunk and limbs of the trial group were also much better. Conclusion: The effect of rhTNFR:Fc is more quick and significant, especially assessed by PASI sore. Abstract not available at the BIUM and United States NLM libraries. No email address for the authors available When we searched Google, we found another abstract of the same study. "Chinese Journal of Dermatology 2007, 40(11) 655‐658" manu41.magtech.com.cn/Jwk_cmazp/EN/abstract/abstract11844.shtml#), which had no supplemental information to enable contacting the authors: Abstract "Objective To investigate the efficacy and tolerability of a recombinant human tumour 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,randomised,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 (methotrexate)(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 methotrexate‐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 analogue 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." No contact with the authors, as we could not find the authors' emails |