Long-term Safety of Rituximab in Primary Sjögren Syndrome: The Experience of a Single Center

Onorina Berardicurti; Viktoriya Pavlych; Ilenia Di Cola; Piero Ruscitti; Paola Di Benedetto; Luca Navarini; Annalisa Marino; Paola Cipriani; Roberto Giacomelli

doi:10.3899/jrheum.210441

Long-term Safety of Rituximab in Primary Sjögren Syndrome: The Experience of a Single Center

J Rheumatol. 2022 Feb;49(2):171-175. doi: 10.3899/jrheum.210441. Epub 2021 Oct 15.

Authors

Onorina Berardicurti¹, Viktoriya Pavlych¹, Ilenia Di Cola¹, Piero Ruscitti¹, Paola Di Benedetto¹, Luca Navarini², Annalisa Marino², Paola Cipriani¹, Roberto Giacomelli³

Affiliations

¹ O. Berardicurti, MD, V. Pavlich, MD, I. Di Cola, MD, P. Ruscitti, PhD, P. Di Benedetto, PhD, P. Cipriani, PhD, Department of Biotechnological and Applied Clinical Sciences, Rheumatology Unit, University of L'Aquila, L'Aquila.
² L. Navarini, MD, A. Marino, MD, Roberto Giacomelli, MD, PhD, Rheumatology and Immunology Unit, Department of Medicine, University of Rome Campus Biomedico, Rome, Italy.
³ L. Navarini, MD, A. Marino, MD, Roberto Giacomelli, MD, PhD, Rheumatology and Immunology Unit, Department of Medicine, University of Rome Campus Biomedico, Rome, Italy. r.giacomelli@unicampus.it roberto.giacomelli@univaq.it.

PMID: 34654730
DOI: 10.3899/jrheum.210441

Abstract

Objective: This work aims to evaluate the long-term safety of rituximab (RTX) in primary Sjögren 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' 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 0.06-0.17). Baseline demographics, disease characteristics, European Alliance of Associations for Rheumatology (EULAR) Sjögren'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 ± 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.

Keywords: hypogammaglobulinemia; primary Sjögren syndrome; rituximab; safety.

Publication types

Research Support, Non-U.S. Gov't

MeSH terms

Agammaglobulinemia*
Cohort Studies
Female
Humans
Middle Aged
Rituximab / adverse effects
Sjogren's Syndrome* / drug therapy
Treatment Outcome

Substances

Rituximab