Lupus & antiphospholipid syndrome
Efficacy and safety of guselkumab in patients with active lupus nephritis: results from a phase 2, randomized, placebo-controlled study
- terminated early
- Study terminated early following enrolment challenges (COVID-19 pandemic; Ukraine/Russia crisis)
Authors' conclusion
Guselkumab+background therapy did not demonstrate superior reduction in proteinuria vs placebo+background therapy in this small cohort of patients with active LN.
Study context
- Population
- Adults (18–75 years) with active LN (Class III–IV proliferative nephritis on kidney biopsy) and urine protein-to-creatinine ratio (UPCR) ≥1 mg/mg despite standard-of-care therapyplanned sample 60
- Participants
- 33 adults
- Comparison
- Guselkumab i.v. 400 mg at weeks 0, 4 and 8, then s.c. 200 mg every 4 weeks through week 48, plus background therapy, vs placebo
- Guselkumabn = 17
- Placebon = 16reference
- Primary endpoint
- ≥50% decrease in proteinuria from baseline
- Follow-up
- Week 24
Methodological detailsphase 2, multicentre, double-blind, placebo-controlled
- Phase 2
- Multicentre
- Double-blind
- Placebo-controlled
Primary result
As reported in the abstract
Secondary outcomes
Major secondary endpoints (complete renal response (CRR), sustained steroid reduction, UPCR <0.5 / <0.75 mg/mg, time to CRR, time to treatment failure) · week 24
- No apparent differences were observed in the secondary endpoints
Safety
≥1 adverse event · through end of study · most were of mild-to-moderate severity
Original publication
Efficacy and safety of guselkumab in patients with active lupus nephritis: results from a phase 2, randomized, placebo-controlled study. Rheumatology (Oxford). Published 2 December 2024. doi:10.
Composed by AI from the published abstract and checked against it. How Briefs are made →