Analysis of the efficacy and safety of rituximab in the treatment of systemic sclerosis / 中华风湿病学杂志

ABSTRACT

Objective To observe the efficacy and safety of rituximab in the treatment of systemic sclerosis (SSc).Methods This was a prospective,non-randomized controlled trial.All patients with SSc were hospitalized from January 2011 to August 2015.Fifty-two patients were enrolled,including 15 patients in the intervention group and 37 patients in the control group.Both groups were given cyclophos-phamide and prednisone.The intervention group was also given rituximab 375 mg/m2,once every 4 weeks,a total of 4 treatments.The erythrocyte sedimentation rate (ESR),C-reactive protein (CRP),intedeukin 6 (IL-6),modified Rodnan skin score (mRSS),HRCT,forced vital capacity (FVC％),1％ forced expiratory volume percentage (FEV 1％),percentage of carbon monoxide dispersion percentage (DLCO％) were assessed alternatively before treatment,6 months and 12 months after treatment.The repeated measures analysis of variance and t-test were used for statistical analysis.Results Both groups showed improvement in ESR,CRP,IL-6,mRSS,HRCT,FVC％,FEV1％ and DLCO％ (P＜0.05),but ESR [6 month after treatment (33±9) mm/1 h,12 month after treatment (20±4) mm/1 h],CRP [6 month after treatment (12.7±3.4) mg/L,12 months after treatment (12.7± 3.4) mg/L],IL-6 [6 month after treatment (73±10) pg/ml,12 month after treatment (57±11) pg/ml],mRSS [6 months after treatment (22.2±1.3),12 month after treatment (18.4±3.1)],HRCT score [6 month after treatment (11.9±1.4),12 month after treatment (11.3±1.0)],in patients of the intervention group were decreased more significantly than patients of the control group (P＜0.05),and FVC％ [6 month after treatment (69.0± 3.4)％,12 month after treatment (77.2±4.1)％],FEV1％[6 month after treatment (73.3±3.4)％,12 month after treatment (78.4±1.6)％] and DLCO％ [6 month after treatment (60.6±2.7)％,12 month after treatment (70.7± 3.0)％] were increased more significantly than patients of the control group (P＜0.05).It showed that the efficacy of the intervention group was better than the control group.There was no infusion reactions,infection,hepatitis B virus reactivation and other side effects in the treatment were observed.Conclusion Rituximab can reduce the level of inflammation in patients with SSc and improve skin sclerosis and lung function.Rituximab combined cyclophosphamide is expected to be a new,safe and effective treatment of SSc.