Efficacy and safety study on infliximab with disease-modifying anti-rheumatic drugs in refractory psoriatic arthritis / 中华风湿病学杂志

ABSTRACT

ObjectiveTo explore the efficacy and safety of infliximab combined withdiseasemodifying antirheumatic drugs (DMARDs) in the treatment of psoriatic arthritis.MethodsThis was an openlabeled trial.All subjects fulfilled the Moll and Wright criteria for definite PsA and-had poor response to DMARDs.The patients received combined infliximab and DMARDs.Infliximab 3 mg/kg was infused at weeks 0,2,6,14.After week 14,patients received infliximab 3 mg/kg every 8 weeks.The primary end point was the improvement of psoriatic arthritis response criteria(PsARC) response.The secondary end point was the percentage of patients who had 20％ improvement of modified American College of Rheumatology (ACR20)response.Parameters for efficacy for psoriatic rash was defined as the proportion of modified 50％ and 75％improvement of psoriasis area and severity index scores (PASI).All adverse reactions in the whole observation period were recorded.Chi-square test and repeated measurement data analysis of variance were used for the statistical analysis.ResultsTwenty-one patients completed the 14 weeks treatment.Five patients completed 26-104 weeks treatment,including 2 cases for 104 weeks.At week 14,the percentage of patients achieving PsARC was 84％,the percentage of patients achieving ACR20 was 77％,and the percentage of patients achieving PASI 50 was 76％.At week 14,tender joint counts,swollen joint counts,patient's assessment of pain,patient's global assessment(PGA),physician's global assessment,dermatology life quality index (DLQI),health assessment questionnaire(HAQ) were significantly improved compared with base-line(P＜0.05).Five patients received 26-104 weeks follow-up,including 2 cases for 104 weeks,four patients was stable,the rash and joint symptoms of 1 patient recurred at 104 weeks.The most frequently occurred adverse reactions were upper respiratory tract infection and skin as well as appendage damages.The second most common adverse effect was elevation of liver enzymes.ConclusionThe infliximab combined with DMARDs is effective and safe for the treatment of psoriatic arthritis.