Rituximab in systemic sclerosis A protocol for systematic review

Background: Systemic sclerosis (SSc) is a clinically complex and challenging disease, the most frequent complication of which is interstitial lung disease, which leads to a worse prognosis. In this situation, cyclophosphamide is considered the criterion standard for treatment, despite the controversies regarding its efficacy and toxicity. However, studies using rituximab (RTX) have shown that this drug may be a promising therapeutic option. The objective is to describe a protocol of a systematic review (SR) that analyzes the scientific evidence on the effects of RTX on SSc. Methods: This protocol is guided by the Preferred Reporting Items for Systematic Reviews and Meta-Analyses Protocols. The databases to be searched are PubMed, Scopus, SciELO, LILACS, ScienceDirect, Web of Science, COCHRANE, WHOLIS, PAHO, and EMBASE. The studies that would be included in SR are clinical trials that evaluate the use of RTX in patients with SSc who meet the classification criteria for the disease according to American College of Rheumatology and European League Against Rheumatism (2013) and/or LeRoy criteria will be included in the SR. The data to be extracted are related to the characteristics of the studies: authors, year of publication, study location, type of study, sample size and age, patient characteristics, duration of intervention, therapeutic scheme, follow-up time, main variables, and main results. Results: In our study, we hope to find articles presenting new evidence supporting treatment of SSc with RTX. Conclusions: The SR will present results of scientific evidence for the effects of RTX in SSc. We hope that the results could strengthen clinical decisions for the best treatment of SSc and guide future researches.