Effectiveness of biological drugs in the treatment of xerostomia and salivary hypofunction in patients with Sjögren disease.

BACKGROUND

Sjögren disease (SjD) can involve systemic complications. Advances in understanding its pathophysiology and the development of novel biological agents could herald new possibilities for managing salivary dysfunction in SjD. This investigation was conducted to assess the effectiveness of biological agents in the treatment of xerostomia and hyposalivation in patients with SjD.

TYPES OF STUDIES REVIEWED: A systematic review was conducted following the Preferred Reporting Items for Systematic Reviews and Meta-Analyses methodology. The inclusion criteria were randomized clinical trials (RCTs) involving adult patients who received a diagnosis of SjD, with information on unstimulated whole salivary flow or stimulated whole salivary flow or xerostomia measured using a visual analog scale. The quality of evidence and risk of bias were assessed using the Grading of Recommendations Assessment, Development and Evaluation and Cochrane Collaboration tools, respectively.

RESULTS

Fourteen RCTs were identified, including 4 focused on rituximab (RTX), 1 focused on infliximab, 1 focused on baminercept, 2 focused on abatacept, 1 focused on tocilizumab, 1 focused on remibrutinib, 1 focused on iscalimab, 1 focused on seletalisib, 1 focused on petesicatib, and 1 focused on human interferon (IFN)-α. Twelve were double-blind studies, 1 was double-blind during the first period of the study and open-label during the second period, and 1 was a triple-blind study. Most of the studies were classified as multicenter. The included studies comprised a total of 1,772 patients, with 1,012 in the intervention groups and 760 in placebo groups. RTX, iscalimab, and IFN-α had significant differences reported in 4 RCTs, with an increase in unstimulated whole salivary flow and a significant improvement in dry mouth sensation reported in 1 RCT. No relevant adverse effects were observed.

CONCLUSIONS AND PRACTICAL IMPLICATIONS: RTX, iscalimab, and IFN-α have potential benefits in management of salivary gland dysfunction in SjD. Adequate methodological trials are needed to clarify the role of these agents in SjD. The research protocol was planned and registered with PROSPERO, an international systematic review registry (CRD42024596176), and it was not modified throughout the study.