FRI0247 COMPARISON OF THE RITUXIMAB(RTM) IN MONOTHERAPY REGIMEN AND MYCOPHENOLATE MOFETIL (MMF) EFFICACY AND SAFETY IN SYSTEMIC SCLEROSIS (SSC) WITH INTERSTITIAL LUNG DISEASE (ILD)

Abstract

Background: Although ILD occurs in the majority of patients with SSc, treatment options for this manifestation is empirical and at present consists of cyclophosphamide or MMF. However, the immunosuppressants(IS) use leads to rather limited improvement of ILD and is associated with many adverse reactions. The search for novel, more efficacious agents has been continued, such as attracting much attention RTM. Objectives: To compare the impact of MMF and RTM a single-agent therapy on SSc clinical manifestation and activity, and the safety of these agents in the open-label prospective non-randomized study. Methods: 80 patients with the confirmed SSc diagnosis and ILD evidence based on MSCT findings were enrolled into the study. All patients received low and moderate-dose glucocorticoids regimens. Group A(n=35) received RTM as a single therapy agent for 13.3±2.3 months at total dose 1.35±0,5g(the patient's average age was 45.0±15 years, with female proportion 80%; SSc duration 6.3±2.3 years; diffused/localized forms 1.3/1). Group B(n=36) received MMF for 12±6 months at total dose 10.6±5 g(the average age 49±13 years, females 91%, SSc duration 7.1±5 years, diffused/localized forms 1/1.3). The time courses of FVC, DLCO, modified skin count(mRss, points), activity index (EScSG, points), and cardiac rhythm and conductivity disorders(ECG) were assessed into the study. Results: In Groups A and B the therapy was associated with significant decrease in mRss(p=0.02 and 0.009, respectively) and EScSG(p=0.00017 and 0.000165, respectively). Reducing the number of patients with cardiac conductivity disorders was observed only in MMF-treated patients(p=0.03). Evaluation of FVC time course revealed significant FVC increase only in Group A(p= 0.002), with median increment about 5%. In Group A 10% FVC increase was found in the third of the patients thus exceeding respective parameter in Group B(p=0.2). The patient percentage with FVC decrease by ≥10% did not differ significantly between groups. During the follow-up period no change of the other studied parameters was observed. The therapy was better tolerated in RTM-treated group: during RTM therapy adverse reactions emerged in lower proportion of the patients(4/11%) compared with MMF-treated group(12/27%), p=0,5. (Table Presented) Conclusion: Both agents effectively alleviated skin induration and EScSG, and significantly improved FVC. However, only RTM use revealed significant FVC increase including clinically significant FVC increase. RTM was slightly better tolerated compared to MMF. The study findings substantiate potential use of RTM both as a first-line agent for ILD treatment in the patients with SSc, and in the event of IS inefficacy of poor tolerability. The MMF use is more preferable in patients with less pronounced ILD and cardiopathy.