The Efficacy And Safety Of Methotrexate In The Treatment Of Moderate-to-severe Psoriasis In Chinese Han Population

Background Psoriasis is a multi-gene genetic disease and distributed around the world,the incidence is high.However,the current medical level has not complet ely overcome this worldwide problem,there is no special method to cure psorias is,only control disease development and relieve symptoms by some treatment.T here are many ways to treat psoriasis,of which methotrexate（MTX）is one of t he most potent drugs for the treatment of psoriasis currently and has been in exi stence for 50 years since its approval by the FDA in 1971,Yet its efficacy and safety are still contradictory.Objective An open,prospective and observational trial of Chinese Han patients with psoriasis was conducted to obtain real data on the treatment of moderate to severe psoriasis with low-dose short-course MTX and deepen the understanding of the efficacy and safety of MTX.Method 159 patients with moderate-to-severe psoriasis admitted to Huashan Hospital from April 2015 to July 2017 were selected and treated with MTX low-dose and short-course chemotherapy for 12 weeks.Psoriasis area and severity index（PASI）score and laboratory findings at week 0,4,8 and 12 were recorded during the 12-week treatment.Patients were divided into Psoriatic arthritis（PsA）and Psoriasis vulgaris（PsV）（group 1）,progressive stage and stable stage（group 2）according to their clinical manifestations.Results After 12 weeks of MTX treatment,the mean PASI score decreased from14.28±7.55 at baseline to 4.80±4.53 at the end point,PASI score of PsA d ecreased from 14.90±8.53 to 5.34±4.74,and PsV score decreased from 14.08±5.18 to 4.23±4.15.The average PASI score decreased from 16.00±8.49 t o 5.74±5.50 in patients with progressive stage,while the average PASI score d ecreased from 13.78±6.59 to 4.43±3.84 in stable stage patients.Repeated me asures ANOVA showed that PASI score increased changed significantly with treat ment（p<0.01）.However,no statistically significant difference（p>0.05）was fou nd at the same time point in the observation group.After 12 weeks of MTX tre atment,69（69.8%）of 111 patients achieved PASI 50,70（44.0%）achieved PASI75,31（19.5%）achieved PASI 90.There was a significant difference in PASI 50 response rates between PsA and PsV at weeks 8 and 12（p=0.05,p=0.003,respectively）.In safety assessment,several laboratory tests showed dynamic cha nges.After 12 weeks of MTX treatment,HGB,RBC and WBC were significantl y decreased（P<0.01）,ALT,AST and TBIL were significantly increased(P _ALT=0.009;P_AST=0.02;P _TBIL=0.044).Conclusions In this observational study,it was found that MTX has a significant effect in patients with psoriasis vulgaris and psoriatic arthritis,and has a significant effect in both psoriasis progression and quiescence.After 12 weeks of treatment,44%of the patients had a definite curative effect,which improved the lesions quickly and effectively controlled the skin inflammation.In this low-dose and short-course MTX standard program for the treatment of psoriasis,some of the patients’laboratory tests showed abnormal changes in the early treatment and no serious or irreversible adverse events were observed.Low-dose and short-course MTX treatment of moderate to severe psoriasis with rapid onset,stable response,fewer serious adverse events,low prices,etc.,can be used as the preferred treatment drugs of psoriasis.However,during the treatment period,hematuria,liver and kidney function,blood glucose and blood lipids should still be tested regularly to detect adverse events as soon as possible,give symptomatic treatment as soon as possible or reduce the dosage of drugs and prevent serious adverse reactions.During the treatment,the doctor should also give the patient a careful physical and psychological care to help patients alleviate the condition as soon as possible.