OP0187 RITUXIMAB AND CYCLOPHOSPHAMIDE COMPARISON FOR EFFICACY AND SAFETY IN THE PATIENTS WITH SYSTEMIC SCLEROSIS ASSOCIATED WITH INTERSTITIAL LUNG DISEASE
Authors: Olga Koneva, Lidia P. Ananyeva, Liudmila Garzanova, Oxana Desinova, Olga Ovsyannikova, Mayya Starovoytova
Journal: Annals of the Rheumatic Diseases (2019)

<h3>Background</h3> Cyclophosphamide (CyP) is considered as a drug of choice for the treatment of interstitial lung disease (ILD) in the patients with systemic sclerosis (SSc). However, according to the literature, the use of CyP leads to rather limited and transient improvement of the pulmonary fibrosis. In this context the search for novel, more efficacious agents has been continued, such as attracting much attention retuximab (RTM). <h3>Objectives</h3> To compare the impact of CyP and RTM on SSc clinical manifestation and activity, and the safety of these agents in the open-label prospective non-randomized study. <h3>Methods</h3> 107 patients with the confirmed SSc diagnosis and ILD evidence based on HRCT findings were enrolled into the study. All patients received low-dose and moderate-dose prednisolone regimens. 36 patients (<b>Group A) received parenteral CyP</b> for 12±6 months at total dose 10.6±5 g (the average age 47±12 years, females 92%, SSc duration 5.0±4.8 years, diffused/localized forms 1.6/1). 71 patients (<b>Group B) received RTM</b> at total dose 1.43±0.66 g over the follow-up period 13.2±2 months (the average age 46±13 years, females 83%, SSc duration 5.6±4.4 years, diffused/localized forms 1.4/1); to 32 (45%) of them RTM was added to immunosupressants due to inadequate efficacy of the latter. The time courses FVC(%), modified skin count (mRss, points), activity index (EScSG, points), left ventricle ejection fraction (LVEF,%), mean pulmonary arterial pressure (EchoCG), and cardiac rhythm and conductivity disorders (ECG) were evaluated. <h3>Results</h3> In Groups A and B the therapy was associated with significant decrease in mRss (p=0.009 and 0,001, respectively) and EScSG (p=0.000165 and 0.001, respectively). Increase in LVEF (61.8±7.3 и 63.6±7.3. p=0.02) was observed only in RTM-treated patients. Evaluation of FVC time course in Groups A and B revealed significant FVC increase (p= 0.034 and 0.000045, respectively), with median increment about 5%. In Group A FVC 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% was similar in both 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 significantly lower proportion of the patients (11/14%) compared with CyP-treated group (19/53%), p=0,0000. <h3>Conclusion</h3> Both agents effectively alleviated skin induration and EScSG, and significantly improved FVC. However, CyP use for a year slightly more frequently resulted in clinically significant FVC increase, probably due to low RTM cumulative dose. RTM was better tolerated compared to CyP. The study findings substantiate potential use of anti-B-cell therapy both as a first-line agent for ILD treatment in the patients with SSc, and in the event of CyP inefficacy of poor tolerability, especially in the patients with cardiopathy. <h3>Disclosure of Interests</h3> None declared