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Background: 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. Objectives: 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. Methods: 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 (UCLASCTCGIT₂. 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. Results: 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). Conclusion: 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. REFERENCES: NIL. Acknowledgements: Supported by MHCR023728. Disclosure of Interests: None declared.
Oreská et al. (Sat,) studied this question.