Objective This work aims to evaluate the long-term safety of rituximab (RTX) in primary Sjögren's syndrome (pSS) to determine the safety and the efficacy of long-term treatment with B cell depleting therapy in pSS patients with active systemic disease. Methods An historical cohort study, enrolling 35 pSS patients treated with RTX, between 2008 and 2019, in a single Rheumatologic Unit was performed. When patients experienced adverse events, the treatment was suspended, and patients' data were recorded. Results The included patients were mainly female (91%) with a mean age of 54 years. During the observation, 13 patients (37.1%) suspended RTX treatment (10 cases per 100 patient-years, 95% CI: 0.061-0.17). Baseline demographics, disease characteristics, ESSDAI values, and treatment were comparable across RTX-suspended and non-suspended. Patients exposed to RTX had been followed for 35.82 ± 32.56 months, and the time of observation varied from 96 to 6 months. All the patients, except one, experienced a significant and persisting meaningful improvement of their ESSDAI (≥ 3 points) during the long-time follow-up. For the duration of the follow-up, 13 (37%) patients discontinued RTX treatment. Four out of 13 (30.8%) discontinued the treatment after the first infusion due to infusion-related reactions. During subsequent courses, the main cause of withdrawal was hypogammaglobulinemia onset (7 patients). In 2 patients, hypogammaglobulinemia was associated with severe infections. Conclusion RTX long-term administration showed to be a safe, well-tolerated, and effective treatment in patients with active systemic disease, significantly reducing ESSDAI, and the control of the disease activity last for years.
Do Autoantibodies Predict Autoimmune Liver Disease in Primary Sjögren's Syndrome? Data of 180 Patients upon a 5 Year Follow-Up
