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European Journal of Dermatology

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Treatment of psoriasis with recombinant human LFA3-antibody fusion protein: a multi-center, randomized, double-blind trial in a Chinese population Volume 21, numéro 5, September-October 2011

Auteurs
Dermatology Department, Pharmaceutical Preparation Section, Southwest Hospital, Third Military Medical University, 29 Gaotanyan Main Street, Chongqing, Dermatological Department, First affiliated Hospital, Zhengzhou University, Henan, Institute of Dermatology, Chinese Academy of Medical Science, Nanjing, Dermatology Department, West China Hospital, Sichuan University, Chengdu, Dermatology Department, Xinqiao Hospital, Third Military Medical University, Chongqing, Dermatology Department, Changhai Hospital, Second Military Medical University, Sahnghai, Dermatology Department, Xijing Hospital, Fourth Military Medical University, Xian, International Cancer Research Institute, Second Military Medical University, Shanghai, National Engineering Research Center of Antibody Medicine, Shanghai, China

To evaluate clinical efficacy and safety of injectable recombinant human LFA3-antibody fusion protein (rhLFA3-IgFP), a multi-center, randomized, double-blind, double-dummy, parallel-controlled clinical trial was performed in 212 cases of moderate to severe psoriasis. Intramuscular injection of rhLFA3-IgFP (15 mg/week) and oral administration of blank dummy methotrexate at the dose of 7.5 mg/week was performed in the patients in the experimental group, and control patients were orally administered with methotrexate at the dose of 7.5 mg/week and intramuscularly injected with the blank dummy rhLFA3-IgFP (15 mg/week). PASI was determined prior to and at 2, 4, 6, 8, 12, 16, 20 weeks after the treatment. The efficacy evaluation was carried out on 192 patients, and no significant differences were found in PASI50, PASI75 & PASI90 between the two groups after twelve weeks’ treatment (p>0.05). After discontinuation, PASI scores continued to decrease drastically in the experiment group, whereas they increased in the control group. At 8 weeks after discontinuation, PASI scores were decreased by 62.32% (p<0.05) and 52.67% (p<0.05) in the experimental and control groups, respectively. No serious adverse reactions were observed. In conclusion, the results of our investigation demonstrated that rhLFA3-IgFP was an effective therapy for chronic plaque psoriasis with lasting action and low incidence of adverse reactions.