Safety of rituximab in Sjogren's syndrome

This is a summary of a study done into the long-term safety of the use of rituximab in people with Sjogren's syndrome. It was a study conducted in a Rheumatology Unit in a university in Italy. 

Fab domain of rituximab with a peptide epitope

The study aimed to evaluate the long-term safety of rituximab in primary Sjögren's syndrome (pSS) to determine the safety and efficacy of long-term treatment in pSS patients with active systemic disease.

Rituximab (RTX) is a B cell depleting therapy, that can reduce inflammation and joint damage. It was approved for medical use in 1997 and is on the World Health Organization's List of Essential Medicines. It is given by intravenous therapy which is a medical technique that delivers the medication directly into a person's vein. 

EULAR Sjögren's syndrome disease activity index (ESSDAI) is a systemic disease activity index that was generated in 2009. It is used in most clinical studies and ongoing randomized controlled trials. It gives an overview of a patient's systemic disease activity in 12 different domains including organ systems: cutaneous, respiratory, renal, articular, muscular, peripheral nervous system, central nervous system, hematological, glandular, constitutional, lymphadenopathic, biological.

35 patients who were treated with RTX, between 2008 and 2019, were in the study. Their adverse events to the treatment were recorded. 

91% of the patients were female. The average age was 54 years. 

Baseline demographics, disease characteristics, ESSDAI values, and treatment were comparable across all participants. 

Patients given RTX had been followed for between 32 and 36 months.

EULAR Sjögren's syndrome disease activity index (ESSDAI) is a systemic disease activity index that was generated in 2009. It is used in most clinical studies and ongoing randomised controlled trials. It gives an overview of a patient's systemic disease activity in 12 different domains including organ systems: cutaneous, respiratory, renal, articular, muscular, peripheral nervous system, central nervous system, hematological, glandular, constitutional, lymphadenopathic, biological.

Results:  

• 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.

Long-term safety of rituximab in primary Sjögren's syndrome: the experience of a single center.

Image thanks to Oguenther who is a Ph.D. in natural science (diploma chemist).