Ianalumab lowered Sjögren's activity scores slightly, but patients did not feel better

Design

Two phase 3, randomised, double-blind, placebo-controlled trials over 52 weeks

Population

779 adults with active Sjögren's disease

Primary outcome

Change in ESSDAI score at week 48

Effect

Difference −1.3 (−2.6 to 0.0) and −1.0 (−2.0 to 0.0) points vs placebo

NEPTUNUS-1 and NEPTUNUS-2 randomised 779 people with active Sjögren's disease to subcutaneous ianalumab, an antibody that depletes B cells and blocks the BAFF receptor, or placebo for 52 weeks.

Monthly ianalumab reduced the physician-scored disease activity index (ESSDAI) by 1.3 points more than placebo in one trial (95% CI −2.6 to 0.0) and 1.0 point in the other (−2.0 to 0.0), both just reaching significance on a scale running to 123. The proportion achieving a meaningful response did not differ, and neither did patient-reported dryness, fatigue or pain scores. Serious adverse events were similar; injection reactions were more common.

Sjögren's has no approved targeted therapy, so any positive phase 3 result draws attention. But a one-point change with no symptom benefit is a thin basis for a new treatment, and how regulators weigh it is unknown.

• Patients with Sjögren's may ask about ianalumab; the trial showed no improvement in how they felt.
• Symptomatic care for dryness and fatigue remains the core of management.
• Look for systemic features — vasculitis, nephritis, neuropathy, lymphadenopathy — that need specialist review.
• Treat a one-point index change as statistically significant but of uncertain clinical meaning.

Why it matters

It shows how a 'positive' trial can leave the patient's experience unchanged.

Don't overread it

A statistically significant one-point change, with no symptom benefit, does not establish a clinically useful treatment.

The statistics, in plain English

Both confidence intervals end at 0.0, meaning the results sit right on the edge of significance. On a 123-point scale, a 1-point difference is small, and the lack of any patient-reported benefit suggests it may not be noticeable.

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