@article {Berardicurti171, author = {Onorina Berardicurti and Viktoriya Pavlych and Ilenia Di Cola and Piero Ruscitti and Paola Di Benedetto and Luca Navarini and Annalisa Marino and Paola Cipriani and Roberto Giacomelli}, title = {Long-term Safety of Rituximab in Primary Sj{\"o}gren Syndrome: The Experience of a Single Center}, volume = {49}, number = {2}, pages = {171--175}, year = {2022}, doi = {10.3899/jrheum.210441}, publisher = {The Journal of Rheumatology}, abstract = {Objective This work aims to evaluate the long-term safety of rituximab (RTX) in primary Sj{\"o}gren syndrome (pSS) and to determine the safety and the efficacy of long-term treatment with B cell depleting therapy in pSS patients with active systemic disease.Methods A historical cohort study, enrolling 35 patients with pSS 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{\textquoteright} data were recorded.Results The included patients were mainly female (91\%), with a mean age of 54 years. During the time of observation, 13 patients (37.1\%) suspended RTX treatment (10 cases per 100 patient-years, 95\% CI 0.06{\textendash}0.17). Baseline demographics, disease characteristics, European Alliance of Associations for Rheumatology (EULAR) Sj{\"o}gren{\textquoteright}s Syndrome Disease Activity Index (ESSDAI) values, and treatment were comparable across RTX-suspended and nonsuspended groups. Patients exposed to RTX had been followed for 35.82 {\textpm} 32.56 months, and the time of observation varied from 6 to 96 months. All the patients except one experienced a significant and persisting meaningful improvement of their ESSDAI (>= 3 points) during the long-term 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 administration due to infusion-related reactions. During subsequent RTX courses, the main cause of withdrawal was hypogammaglobulinemia onset (7 patients). In 2 patients, hypogammaglobulinemia was associated with severe infections.Conclusion Long-term RTX administration was shown to be a safe, well tolerated, and effective treatment in patients with active systemic disease, significantly reducing ESSDAI and controlling disease activity.}, issn = {0315-162X}, URL = {https://www.jrheum.org/content/49/2/171}, eprint = {https://www.jrheum.org/content/49/2/171.full.pdf}, journal = {The Journal of Rheumatology} }