Ianalumab for the Treatment of Patients with Sjögren's Disease.

In 30 seconds

Two 52-week, double-blind, randomized, placebo-controlled phase III trials evaluated monthly or less frequent ianalumab in patients with active Sjögren's disease. In both trials, monthly ianalumab produced a significantly greater reduction in ESSDAI disease-activity score at week 48 than placebo: between-group differences were -1.3 points in NEPTUNUS-1 and -1.0 points in NEPTUNUS-2. However, neither trial showed significant differences in ESSDAI response or patient-reported symptom scores. Serious adverse-event incidence was similar, while nonserious injection-related reactions were more common with ianalumab.

Key findings

• At week 48, the ESSDAI between-group difference for monthly ianalumab versus placebo was -1.3 points (95% CI, -2.6 to 0.0; P = 0.0496) in NEPTUNUS-1.
• In NEPTUNUS-2, monthly ianalumab versus placebo yielded an ESSDAI difference of -1.0 points (95% CI, -2.0 to 0.0; P = 0.04) at week 48.
• Neither trial found significant differences in ESSDAI response or changes in SSSD or ESSPRI symptom scores at week 48.
• Serious adverse-event incidence was similar with ianalumab and placebo; nonserious injection-site and systemic injection-related reactions were more common with ianalumab.

Why it matters

These trials provide randomized evidence that monthly ianalumab can modestly reduce measured disease activity in active Sjögren's disease over 48 weeks. The absence of significant improvement in patient-reported symptoms or the prespecified ESSDAI response outcome is important when interpreting the clinical meaning of the score change. The findings also characterize injection-related reactions alongside serious adverse events.

What to keep in mind

The reported disease-activity differences were modest, and neither trial showed significant benefit on ESSDAI response or patient-reported symptom scores at week 48. The abstract reports outcomes through 52 weeks.