Nipocalimab, Telitacicept, and the Sjögren’s Disease Pipeline

Beyond ianalumab, the Sjögren’s disease pipeline now spans several distinct mechanisms, alongside renewed interest in repurposing familiar immunosuppressants.

In this Special Report series, Nehad Soloman, MD, FACR, of Arizona Arthritis and Rheumatology Associates, spoke with Teja Kapoor, MD, director of the Columbia Sjögren’s Center, about the evolving treatment landscape.

Management has long relied on off-label hydroxychloroquine, azathioprine, and methotrexate, with pilocarpine and cevimeline for dryness. A network meta-analysis previously found leflunomide plus hydroxychloroquine reduced ESSDAI scores compared with placebo.¹

Preliminary NECESSITY trial results were presented at the International Sjögren’s Symposium, with publication pending. They showed hydroxychloroquine combined with mycophenolate or leflunomide met its STAR primary end point, with effect sizes of about 33% to 37%.

Nipocalimab, a neonatal Fc receptor (FcRn) blocker, met its primary end point on the ClinESSDAI in the phase 2 DAHLIAS trial.² Dazodalibep, a CD40 ligand inhibitor, built on positive phase 2 data³ and has reported positive topline phase 3 results, with full data and a symptom-dominant cohort still pending.

Telitacicept blocks both B-cell activating factor (BAFF) and APRIL, which acts further downstream on plasma cells. After strong phase 3 results in China, where it was approved in June 2026, a global phase 3 trial is assessing ESSDAI change at week 48.⁴

Single-target BAFF and APRIL agents have previously disappointed in Sjögren’s disease. Dual-pathway approaches may help explain the recent run of positive trials and could distinguish Sjögren’s disease from other B-cell-driven conditions.

References

1. Yang M, Lu Y, Wang S, Lin S. Efficacy and safety of pharmacological treatment for Sjögren’s disease: a network meta-analysis. Z Rheumatol. 2026;85(8):632-641. doi:10.1007/s00393-026-01824-2

2. Noaiseh G, Sivils KL, Campbell K, et al. Efficacy and safety of nipocalimab in patients with moderate-to-severe Sjögren’s disease (DAHLIAS): a randomised, phase 2, placebo-controlled, double-blind trial. Lancet. 2025;406(10518):2435-2448. doi:10.1016/S0140-6736(25)01430-8

3. St Clair EW, Baer AN, Ng WF, et al. CD40 ligand antagonist dazodalibep in Sjögren’s disease: a randomized, double-blinded, placebo-controlled, phase 2 trial. Nat Med. 2024;30(6):1583-1592. doi:10.1038/s41591-024-03009-3

4. Patel V, Salas A, Grader-Beck T. Clinical trials and new therapies in Sjögren’s disease. Curr Opin Immunol. 2026;100:102743. doi:10.1016/j.coi.2026.102743