Lupus & antiphospholipid syndrome
Efficacy and Safety of Upadacitinib or Elsubrutinib Alone or in Combination for Patients With Systemic Lupus Erythematosus: A Phase 2 Randomized Controlled Trial
Authors' conclusion
Upadacitinib 30 mg alone or in combination with elsubrutinib (ABBV-599 high dose) demonstrated significant improvements in SLE disease activity and reduced flares and were well tolerated through 48 weeks.
Study context
- Population
- Adults with moderately to severely active systemic lupus erythematosus (SLE)enrolled
- Participants
- 341 adults
- Comparison
- Upadacitinib or elsubrutinib alone or in combination vs placebo
- Primary endpoint
- Proportion achieving both SRI-4 and GC dose ≤10 mg QD
- Follow-up
- Week 24
Methodological detailsphase 2, placebo-controlled, 1:1:1:1:1 randomisation, planned interim analysis
- Phase 2
- Placebo-controlled
- 1:1:1:1:1 randomisation
- Planned interim analysis
Primary result
As reported in the abstract
Upadacitinib vs Placebo: P = 0.028 · ABBV-599 high dose vs Placebo: P = 0.081
Further findings
SRI-4, BICLA and Lupus Low Disease Activity State (LLDAS) response rates · weeks 24 and 48
- Higher for both upadacitinib and ABBV-599 high dose vs placebo
Flares and time to first flare · through week 48
- Flares reduced and time to first flare substantially delayed with both upadacitinib and ABBV-599 high dose vs placebo
ABBV-599 low dose and elsubrutinib arms
- Discontinued after planned interim analysis showed lack of efficacy (no safety concerns)
Safety
Adverse events · through week 48
- No new safety signals beyond those previously reported for upadacitinib or elsubrutinib
Original publication
Efficacy and Safety of Upadacitinib or Elsubrutinib Alone or in Combination for Patients With Systemic Lupus Erythematosus: A Phase 2 Randomized Controlled Trial. Arthritis Rheumatol. Published 7 August 2024. doi:10.
Composed by AI from the published abstract and checked against it. How Briefs are made →