Selecting Sjögren’s Patients for Ianalumab and Weighing Safety

As ianalumab approaches potential approval, the question for rheumatologists shifts from whether it works to which patients with Sjögren’s disease should receive it and how safely.

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 patient selection and safety.

Patients with isolated dryness remain uncertain candidates. Phase 3 data showed only a trend toward improved sicca symptoms, and gains in ESSPRI and FACIT-Fatigue scores were numerical rather than statistically significant, despite earlier improvement in patient global assessment.¹

Ultrasound studies suggest the drug reaches glandular tissue, with fewer hypoechoic areas thought to reflect lymphocytic infiltration. Longer follow-up at 18 months or 2 years may clarify whether sicca symptoms improve over time.

For now, the strongest rationale lies in systemic, B-cell-driven disease. Candidates may include patients with parotid swelling, hypergammaglobulinemic purpura, joint involvement, or mild lung manifestations.

Phase 3 rates of adverse events and serious adverse events were broadly comparable with placebo, with injection-site reactions expected for a subcutaneous therapy.¹ Clinicians should still monitor infections, immunoglobulin levels, and cytopenias in a chronic disease requiring years of treatment.²

Lymphoma risk adds another dimension. Whether B-cell-directed therapy might reduce lymphoma development in high-risk patients remains unknown, and longer-term and post hoc analyses will be needed to answer it.

References

1. Mariette X, Grader-Beck T, Finzel S, et al. Ianalumab for the treatment of patients with Sjögren’s disease. N Engl J Med. 2026;395(16):1585-1599. doi:10.1056/NEJMoa2601088

2. Palla P, Chatzis LG, Sipsas NV, et al. Infections in Sjögren’s disease: a clinical concern or not? Clin Exp Rheumatol. 2024;42(12):2531-2541. doi:10.55563/clinexprheumatol/ekder7