POS0873 IMPROVEMENT IN MODIFIED RODNAN SKIN SCORE (MRSS) IN SYSTEMIC SCLEROSIS PATIENTS TREATED WITH RITUXIMAB: A SYSTEMATIC REVIEW AND META-ANALYSIS OF THE SCIENTIFIC LITERATURE
Authors: J. L. Puga Guzmán, D. Fernández Fernández, R. Dos-Santos, I. González Fernández, E. Perez-Pampín, A. Souto Vilas, A. Mera Varela
Journal: Annals of the Rheumatic Diseases (2021)

Background: Systemic sclerosis (SSc) is a chronic autoimmune disease of the connective tissue characterized by vascular disease and fibrosis in different organs and systems such as lung and skin (1). Recently, several case reports and small series of patients reported on the efficacy of rituximab in SSc, showing a possible improvement in skin and lung affectations (2). However, registered clinical trials are lacking to determine factors associated with response, maintenance regimen, and long-term efficacy of rituximab in SSc. Objectives: To analyze the efficacy of Rituximab in the treatment of skin fibrosis using the changes of the modified Rodnan Skin Score (mRSS) of patients diagnosed with systemic sclerosis from the data published in Registered Clinical Trials (RCTs) in the scientific literature. Methods: We perform a systematic review and a meta-analysis using the main electronic databases to locate all the articles available so far: Medline, Embase, Cochrane Library and Web of science and ACR and EULAR abstracts congress were extracted to assess efficacy outcomes. That efficacy was measured based on the variation of mRSS at 12, 24 and 48 weeks for patients treated with Rituximab versus patients treated with another drug or placebo. Results: 3 RCTs contained data regarding mRSS at week 12 of treatment with Rituximab. The estimated SMD was -1.071 (95% CI -1.608, -0.535 [p &lt;0.001]) with a non-significant P value in the Egger Test (P = 0.703) and non-significant heterogeneity through I2 (I2 = 0.00%). 9 studies contained data regarding mRSS at week 24 of treatment with Rituximab. The estimated SMD was -1.743 (CI95% -2.622, -0.864 [p &lt;0.001], see image below ) with a non-significant P value in the Egger Test (P = 0.072) and significant heterogeneity through I2 (I2 = 86.6%). Meta-regression analysis could not be performed to assess such heterogeneity, due to the lack of comparable data. 8 RCTs contained data regarding mRSS at week 48 of Rituximab treatment. The estimated SMD was -1.327 (CI95% -2.018, -0.636 [p &lt;0.001]) with a significant P value in the Egger Test (P = 0.018), estimating that there may be publication bias in the studies analyzed and significant heterogeneity by I2 (I2 = 85.2%). Meta-regression analysis could not be performed to assess such heterogeneity, due to the lack of comparable data. Conclusion: Our meta-analysis shows that Rituximab treatment in patients affected with systemic sclerosis shows efficacy in the treatment of cutaneous fibrosis measured by the mRSS, turning this molecule into a potential drug to add to the therapeutic armamentarium of systemic sclerosis. However, more studies are necessary to try to elucidate whether this change is powerful enough to become the new gold standard for the treatment of systemic sclerosis skin involvement. References: [1]Stern EP, Denton CP. The pathogenesis of systemic sclerosis. Rheum Dis Clin North Am 2015;41:367–82. https://doi.org/10.1016/j.rdc.2015.04.002 . [2]Thiebaut M, Launay D, Rivière S, et al. Efficacy and safety of rituximab in systemic sclerosis: French retrospective study and literature review. Autoimmun Rev. 2018;17(6):582-587. https://doi:10.1016/j.autrev.2017.12.010 . Disclosure of Interests: None declared