Lupus & antiphospholipid syndrome
Deucravacitinib, an oral, selective, allosteric, tyrosine kinase 2 inhibitor, in patients with active SLE: efficacy on patient-reported outcomes in a phase II randomised trial
Authors' conclusion
Patients with SLE experienced greater improvements in pain, fatigue and health-related quality-of-life scores at week 48 with deucravacitinib versus placebo treatment.
Study context
- Population
- Patients with active SLE
- Participants
- 363 patients
- Comparison
- Deucravacitinib 3 mg twice daily, 6 mg twice daily or 12 mg once daily vs placebo
- Placebon = 90reference
- Deucravacitinib 3 mg two times per dayn = 91
- 6 mg two times per dayn = 93
- 12 mg once dailyn = 89
Methodological detailsphase II, 48-week, exploratory endpoints, control-based pattern imputation for missing data
- Phase II
- 48-week
- Exploratory endpoints
- Control-based pattern imputation for missing data
Primary result
As reported in the abstract
week 48
Pain decrease, placebo vs deucravacitinib dose groups (points)
1.3 vs 2.2-2.3
Fatigue score decrease, placebo vs deucravacitinib dose groups (points)
3.4 vs 5.9-7.3
Secondary outcomes
SF-36 scores (mean)
- Mean SF-36 physical score, placebo vs deucravacitinib dose groups
- 41.5 vs ≥44.6
- Mean SF-36 mental score, placebo vs deucravacitinib dose groups
- 45.2 vs ≥46.3
- Greater proportion with clinically meaningful SF-36 improvements with deucravacitinib vs placebo
Pain and fatigue by SRI-4 and BICLA response · week 48
- SRI-4 and BICLA responders reported greater improvements in pain and fatigue than non-responders, regardless of treatment group
- Deucravacitinib generally saw greater SRI-4 and BICLA response rates than placebo
Parts of this Brief are withheld: the automatic checks could not confirm them against the abstract.
Original publication
Deucravacitinib, an oral, selective, allosteric, tyrosine kinase 2 inhibitor, in patients with active SLE: efficacy on patient-reported outcomes in a phase II randomised trial. Lupus Sci Med. Published 1 June 2025. doi:10.
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