Sjögren's disease & overlap diseases
Safety and Efficacy of Ianalumab in Patients With Sjögren's Disease: 52‐Week Results From a Randomized, Placebo‐Controlled, Phase 2b Dose‐Ranging Study
Authors' conclusion
In patients with SjD, ianalumab 300 mg demonstrated sustained efficacy through week 52 and a favorable safety profile up to two years of follow-up.
Study context
- Population
- Patients with Sjögren's disease (SjD)90 entered TP2
- Participants
- 190 patients
- Comparison
- Ianalumab 5, 50 or 300 mg sc every 4 weeks vs placebo; at week 24, 300 mg rerandomised to continue 300 mg or placebo until week 52
- Placebon = 49reference
- 5 mgn = 47
- 50 mgn = 47
- 300 mgn = 47
- Primary endpoint
- 52-week safety and efficacy of ianalumab
- Follow-up
- Week 52
Methodological detailsplacebo-controlled, phase 2b, dose-ranging, rerandomisation at week 24, 81 of 90 (90.0%) completed TP2 study treatment
- Placebo-controlled
- Phase 2b
- Dose-ranging
- Rerandomisation at week 24
- 81 of 90 (90.0%) completed TP2 study treatment
Primary result
As reported in the abstract
Efficacy change from week 24 in patients continuing 300 mg in TP2
ESSDAI change from week 24
−1.45
ESSPRI change from week 24
−0.46
Patient global assessment change from week 24
−4.69
Physician global assessment change from week 24
−6.86
Further findings
Stimulated salivary flow rates and autoantibody levels
- Numerically improved in the 300 mg group
Safety
Treatment-emergent adverse events
- Not dose-dependent, except for injection-site reactions
Grade 3 decreased neutrophil counts (CTCAE v4.03) during posttreatment follow-up
- Onset after last ianalumab administration (months)
- 3.5, 5.5, and 3
- Patients with grade 3 decreased neutrophil counts
- None associated with infection except one incidental asymptomatic cytomegalovirus infection (IgM-positive)
Original publication
Safety and Efficacy of Ianalumab in Patients With Sjögren's Disease: 52‐Week Results From a Randomized, Placebo‐Controlled, Phase 2b Dose‐Ranging Study. Arthritis Rheumatol. Published 5 January 2025. doi:10.
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