Lupus & antiphospholipid syndrome
Deucravacitinib, a Tyrosine Kinase 2 Inhibitor, in Systemic Lupus Erythematosus: A Phase II , Randomized, Double‐Blind , Placebo‐Controlled Trial
Authors' conclusion
Deucravacitinib treatment elicited higher response rates for SRI-4 and other end points compared with placebo, with an acceptable safety profile, in adult patients with active SLE.
Study context
- Population
- Adults with active systemic lupus erythematosus (SLE), 162 sites in 17 countriesrandomised 1:1:1:1
- Participants
- 363 adults
- Comparison
- Deucravacitinib 3 mg twice daily, 6 mg twice daily or 12 mg once daily vs placebo
- Primary endpoint
- SRI-4 response
- Follow-up
- Week 32
Methodological detailsphase II, double-blind, placebo-controlled, multicentre (162 sites in 17 countries)
- Phase II
- Double-blind
- Placebo-controlled
- Multicentre (162 sites in 17 countries)
Primary result
As reported in the abstract
Each group vs placeboOdds ratio (95% CI)P value
Deucravacitinib 3 mg BID
2.8(1.5–5.1)
P < 0.001 versus placeboDeucravacitinib 6 mg BID
1.9(1.0–3.4)
P = 0.02 versus placeboDeucravacitinib 12 mg QD
1.6(0.8–2.9)
nominal P = 0.08 versus placeboSecondary outcomes
BICLA, CLASI-50, Lupus Low Disease Activity State (LLDAS) and joint count responses
- Response rates higher with deucravacitinib than placebo
Original publication
Deucravacitinib, a Tyrosine Kinase 2 Inhibitor, in Systemic Lupus Erythematosus: A Phase II , Randomized, Double‐Blind , Placebo‐Controlled Trial. Arthritis Rheumatol. Published 11 November 2022. doi:10.
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