Lupus & antiphospholipid syndrome
B cell depletion and BAFF receptor blockade with ianalumab (VAY736) for the treatment of moderate-to-severe systemic lupus erythematosus: a phase 2 randomised, double-blind, placebo-controlled trial with subsequent open-label treatment
Authors' conclusion
At week 28, reduced disease activity was observed in patients with SLE receiving ianalumab plus standard therapies compared with those receiving standard therapies alone, with sustained benefits with further treatment until 1 year, which was well tolerated.
Study context
- Population
- Patients with active systemic lupus erythematosus (SLE) on standard therapiesrandomised
- Participants
- 67 patients
- Comparison
- Monthly subcutaneous ianalumab 300 mg vs placebo, combined with standard therapies
- Ianalumabn = 34
- Placebon = 33reference
- Primary endpoint
- Composite of SRI-4 at week 28 in patients successfully achieving CS tapering criteria
- Follow-up
- Week 28
Methodological detailsblinded, placebo-controlled, 1:1 randomisation, open-label ianalumab until week 48, interim analyses on the week 68 dataset, Interim analyses on the week 68 dataset; Open-label (OL) ianalumab until week 48, off-treatment to week 68
- Blinded
- Placebo-controlled
- 1:1 randomisation
- Open-label ianalumab until week 48
- Interim analyses on the week 68 dataset
- Interim analyses on the week 68 dataset; OL ianalumab until week 48, off-treatment to week 68
Primary result
As reported in the abstract
SRI-4 with successful CS tapering
Further findings
Primary composite endpoint, sustained (ianalumab) and after placebo transitioned to OL ianalumab · week 52
- Primary composite endpoint, sustained (ianalumab) and after placebo transitioned to OL ianalumab: Placebo group received OL ianalumab after week 28
Other disease activity outcomes (SRI-6, DORIS, LLDAS, flare reduction, corticosteroid (CS) use) · week 28
- Positive treatment effects consistently observed, with clinical benefits until weeks 52 and 68
Safety
Serious adverse events and serious infections
- Ianalumab not associated with increased serious adverse events or serious infections
Nonserious local injection site reactions
- More frequent with ianalumab
Original publication
B cell depletion and BAFF receptor blockade with ianalumab (VAY736) for the treatment of moderate-to-severe systemic lupus erythematosus: a phase 2 randomised, double-blind, placebo-controlled trial with subsequent open-label treatment. Ann Rheum Dis. Published 5 December 2025. doi:10.
Composed by AI from the published abstract and checked against it. How Briefs are made →