FRI0325 Rituximab in primary sjÖgren’s syndrome: a systematic review on its efficacy

Background Primary Sjogren’s syndrome (pSS) is a systemyc autoimmune disease that produces a limpho-plasmocitary infiltrate of the exocrine glands. Considering the primary role attributed to B-lymphocytes in pSS pathophysiology, it has been suggested that Rituximab (RTX) may have certain role in controlling the disease. Objectives To evaluate RTX efficacy in the treatment of xerostomia, xerophthalmia and systemic manifestations (including fatigue) in patients with pSS. Methods In the framework of the preparation of a recommendations document of the Spanish Society of Rheumatology on the use of biologics in pSS, a systematic search of the literature was carried out (until May 2017). Were included adults older than 18 years who met the 2002 American European Consensus Criteria, treated with RTX, with desired comparison to groups treated with other drugs or with placebo and a follow-up time of 6 months. The quality of the studies was assessed through the levels of evidence (LOE) of SIGN scale. Results The search resulted in a total of 749 articles and only 9 of them were selected (figure 1) . The best available evidence for each variable studied is summarised in chart 1 (”+” significant improvement; ”-” no significant improvement). The most relevant results obtained in the studies with LOE 1+ , showed significant differences comparing RTX with lacebo (p I mmunoglobulin’s G (1.2 g/L; 95% CI 0.4 to 2 g/L), A, M and beta2-microglobulin (1.6 g/L; 95% CI 0.5 to 2 g/L) at 24 w. The studies with LOE 3 also report improvement in a percentage of patients in other systemic manifestations, but without demonstrating statistical significance. Conclusions The studies of high methodological quality that evaluate the efficacy of RTX in pSS do not find significant improvement in the primary outcome variables, such as ESSDAI, glandular involvement and other objective parameters of dryness. However, open and retrospective studies find significant improvement in activity parameters, systemic manifestations, glandular involvement and improvement of certain objective tests of dryness. Disclosure of Interest None declared