Despite major advances in understanding Sjögren’s disease (SjD), no approved disease-modifying therapies have been approved. Management remains largely symptomatic with the use of off-label immunomodulators for systemic features. This gap highlights the substantial unmet need for targeted treatment. Encouragingly, the therapeutic landscape is shifting. Several phase 2 trials have shown meaningful efficacy signals, and for the first time, phase 3 programs with ianalumab and telitacicept have demonstrated positive outcomes, particularly when systemic activity is assessed using the EULAR Sjögren’s Syndrome Disease Activity Index. These successes reflect both the maturation of the therapeutic pipeline and important refinements in trial design. Insights from earlier negative studies have underscored the importance of enrolling patients with active disease, incorporating biomarker-defined subgroups, and development of composite endpoints that integrate systemic, symptomatic, and functional domains. Together, these developments suggest that SjD may finally be approaching an era of effective, disease-modifying therapy.
Patel et al. (Tue,) studied this question.