AB1207 RITUXIMAB IN PATIENTS WITH SYSTEMIC SCLEROSIS NON-RESPONSIVE TO CsDMARDs – PRELIMINARY RESULTS OF A PROSPECTIVE, OBSERVATIONAL, MONOCENTRIC STUDY
Authors: S. Oreska, A. Jirankova, A. Bobrova, K. Bobrova, B. Heřmánková, H. Štorkánová, H. Ciferská, K. Pavelka, L. Šenolt, J. Vencovský, R. Bečvář, M. Tomčík
Journal: Annals of the Rheumatic Diseases (2024)

<h3>Background:</h3> Currently, there are only a few bDMARDs with limited evidence of efficacy for the treatment of patients with systemic sclerosis (SSc) with progressive disease non-responsive to csDMARDs. <h3>Objectives:</h3> The aim of this study was to assess the efficacy of rituximab in SSc patients with progressive skin involvement and/or polyarthritis and/or interstitial lung disease (ILD) non-responsive to methotrexate and/or cyclophosphamide and/or mycophenolate in a monocentric, prospective, observational study. <h3>Methods:</h3> In total, 24 SSc patients, who fulfilled the 2013 ACR/EULAR classification criteria (3 males/ 21 females, 5 lcSSc/19 dcSSc, mean±SD age 48±14 years, disease duration 5.7±3.4 years, modified Rodnan skin score (mRSS) 17±11, disease activity (ESSG, European Scleroderma Study Group) 4.1±2.0) with progressive skin thickening and/or arthritis and/or ILD non-responsive to methotrexate/myocphenolate/cyclophosphamide were treated with 2 (n=8) or 3 (n=16) series of rituximab (1g i.v. at day 0 and 14, every 6 months). Before each series of rituximab, patients were assessed by a rheumatologist experienced in the evaluation of mRSS, finger-to-palm (FTP) distance, inter-labial/incisal distance, and disease activity (Visual Analog Scale (VASph); ESSG), and filled out patient-reported outcomes assessing global function (Scleroderma Health Assessment Questionnaire, SHAQ), quality of life (Medical outcomes study Short Form 36, SF-36), fatigue (Fatigue Impact Scale, FIS), depression (Beck's Depression Inventory-II, BDI-II), physical activity (Human Activity Profile, HAP), gastrointestinal (UCLA_SCTC_GIT_2.0) and pulmonary (St. George´s Respiratory Questionnaire, SGRQ) symptoms. Furthermore, peripheral blood was analyzed for routine laboratory parameters (e.g., CRP, ESR, C3 and C4 complement levels), and stored for biobanking. <h3>Results:</h3> We observed a statistically significant improvement in mRSS and disease activity (VASph, ESSG) at months (M) 6 and 12, accompanied by a significant increase in C3 (M6, M12) and C4 (M6) levels and a borderline decrease in ESR (M12). Furthermore, we detected a trend toward an increase in Forced Vital Capacity (FVC) at M12 along with a significant improvement in activities impacted by breathlessness (SGRQ-Activity Scale). In addition, we demonstrated a significant improvement in the function of the left hand (deltaFTP-left-hand, M6), a borderline improvement in deltaFTP-right-hand (M6), a borderline improvement in the overall function (HAQ, M12), significant reduction of depression (BDI-II, M6), and a trend toward an improvement in mental aspects of the quality of life (SF-36-Mental Component Summary, M6) (Table 1). <h3>Conclusion:</h3> Treatment with rituximab in SSc patients with progressive skin-/articular-/ILD- involvement non-responsive to csDMARDs significantly improved the skin score, disease activity, hand function, breathlessness, depression, and increased complement levels. <h3>REFERENCES:</h3> <b>NIL.</b> <h3>Acknowledgements:</h3> Supported by MHCR023728. <h3>Disclosure of Interests:</h3> <b>None declared.</b>