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Sjögren's syndrome is an autoimmune disease characterized by inflammation of the exocrine glands. The disease can be primary or secondary (if it is associated with another autoimmune disease). In Barring symptom management, there is no established treatment. To evaluate the effectiveness and safety of abatacept as a treatment of primary Sjögren's syndrome over the course of 24 months. Eleven patients with primary Sjögren's syndrome from the Rheumatology Department of Universidade Santo Amaro, Sao Paulo, Brazil were enrolled for a prospective observational study. Eligible participants were diagnosed according to the 2002 American-European consensus criteria and had a score greater than 3 on the EULAR Sjögren's Syndrome Disease Activity Index (ESSDAI). Participants received intravenous abatacept for 24 months at a weight-adjusted dose of 500 mg for patients weighing 60 kg and 750 mg for those weighing 60 kg. The outcomes were ESSDAI activity index, non-stimulated salivary flow rate, ocular dryness (Schirmer test, tear film break-up time, and ocular staining score), SF-36 questionnaire, and Fatigue domain of the FACIT (Functional Assessment of Chronic Illness Therapy) index. There was a statistically significant reduction in ESSDAI index and improvement of salivary flow. One subscale of the SF-36 index-emotional role functioning-showed improvement. There was no change in ocular parameters or in the FACIT index. In this sample of 11 patients with primary Sjögren's syndrome, abatacept therapy improved xerostomia and systemic disease activity.Key Points• Abatacept is safe and effective for the treatment of primary Sjögren's syndrome.• Abatacept can improve salivary flow and ESSDAI index in this patient population.

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Introduction: Primary Sjogren’s syndrome (SSp) is a systemic autoimmune disease concerning the exocrine glands and internal organs. Therapeutic options mainly include symptomatic and supportive measures, whereas traditional immunosuppressive drugs have not presented efficacy in randomized trials. Abatacept is a T-cell co-stimulation modulator and there are evidences that this drug may be effective for treating Pss. Objectives: The objective of this trial was to evaluate effectiveness and safety of abatacept for 24 months in the treatment of pSS. Methods: Observational prospective study for 24 months. It was included 11 patients that filled the American-European Consensus criteria (2002). Patients received abatacept according the weight Results: This study was constituted from 11 women between the ages 25 to 81 years (average: 53.73 ± 15.07 years), being the majority afro-descendant women (54.5%). Of this total, 90.9% presented positive antinuclear antibody (ANA), 81.8% positive anti/SSA, and 90.9% positive rheumatoid factor. In relation to ESSDAI, 81.8% of the participants presented scores greater than 5. There was a statistically significant reduction in the ESSDAI IC 2.99 [-0.49; 7.99] (p = 0.013). Between the sub items of the ESSDAI, the ones that demonstrated the greatest modifications were articular and glandular. There was a significant increase in the salivary flow of the participants (dif = -0.90; IC-95%: -1.50; -0.50] after 24 months of treatment. There was no statistical difference between the beginning and after 24 months of treatment in the different evaluations, Schimer’s ophthalmologic right eye IC 2.26 [-3.50; 12.5] p=0.423, Break up time OD 0.50 [-1.00; 2.49] p=0.307, OSS right eye IC: 0.50 [-2.50; 5.50] p=0.721. In the SF36 only in the Limitation for Emotional Aspects sub scale reported significant improvement (dif = 36.4; IC95%: -67.1; -5.57; p = 0.025), and FACIT presented no evidences of significant changes between pre and post treatment p = 0.356. Conclusion: The study demonstrates limitations due to the few number of patients included and for being an open study not controlled, but we observed a statistically significant reduction in the ESSDAI, increase in the salivary flow and in the sub scale Limitation for Emotional Aspects of the SF36, indicating a positive effect in the disease. References [1] Clair E.W. ST. Sjogren’s syndrome in: Gary S. Firestein MD, Ralph C. Budd MD, Sherine E. Gabriel MD MSc, et al.Kelley & Firestein’s Textbook of Rheumatology, Tenth Edition. Elsevier 2017 73:1221-44. [2] Tsuboi H, Matsumoto I, Hagiwara S, et al. Effectiveness of abatacept for patients with Sjogren’s syndrome associated with rheumatoid arthritis. An open label, multicenter, one-year, prospective study: ROSE (Rheumatoid Arthritis with Orencia Trial toward Sjogren’s syndrome Endocrinopathy) trial. Mod Rheumatol 2016; 26(6):891-899 Disclosure of Interests: None declared