英夫利西单抗联合改变病情抗风湿药治疗难治性银屑病关节炎的临床疗效及随访观察

目的 探讨英夫利西单抗联合2种以上改变病情抗风湿药(DMARDs)治疗难治性银屑病关节炎( PsA)的临床疗效与安全性.方法 本研究为开放性临床研究.选择2种及2种以上DMARDs治疗3个月以上无效的PsA患者,分别于0、2、6、14周(之后每间隔8周使用1次)静脉滴注英夫利西单抗(3 mg/kg),联合DMARDs治疗.以PsA疗效标准(PsARC)为主要疗效指标,修改的美国风湿病学会疗效标准提高20％(ACR20)为次要疗效指标,对关节病变进行评估,以银屑病皮损面积和严重性指数(PASI)提高50％、75％ (PASI 50、PASI 75)为银屑病皮损疗效指标,对皮肤病变进行评估；并分析具体评价指标包括压痛关节数、肿胀关节数、疼痛视觉模拟评分、患者总体评价(PGA)、医生总体评价、皮肤病生命质量指数( DLQI)、健康评估问卷(HAQ)]的变化.记录在整个观察过程中发生的所有不良反应.统计学方法采用x2检验和重复测量数据的方差分析检验.结果 共21例患者纳入研究,21例患者全部完成14周的临床疗效评估,其中5例完成26～104周临床观察,2例进行了长达104周的临床观察.治疗14周时21例患者达到PsARC的比例分别为84％,达到ACR20的比例分别为77％,达到PASI 50改善的比例为76％,达到PASI 75改善的比例为68％.14周时患者压痛关节数、肿胀关节数、疼痛视觉模拟评分、PGA、医生总体评价、DLQI、HAQ均显著低于基线水平(P＜0.05),且与治疗前相比差异具有统计学意义.5例患者进行了26～104周随访观察,其中2例进行了长达104周的临床观察,4例患者病情平稳,1例患者于104周时皮疹与关节症状反复.最常见的不良反应为上呼吸道感染和皮肤及其附属器官的损害,其次是肝功能异常.结论英夫利西单抗联合DMARDs治疗PsA有效、安全、可行.

Efficacy and safety study on infliximab with disease-modifying anti-rheumatic drugs in refractory psoriatic arthritis

Objective To explore the efficacy and safety of infliximab combined with diseasemodifying antirheumatic drugs (DMARDs) in the treatment of psoriatic arthritis.Methods This 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.Results Twenty-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.Conclusion The infliximab combined with DMARDs is effective and safe for the treatment of psoriatic arthritis.