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Impact of deucravacitinib on arthritis in patients with systemic lupus erythematosus: results from the phase II PAISLEY SLE study

Year: 2026

Type: article

Abstract: Objective Assess the impact of deucravacitinib, an oral, selective tyrosine kinase 2 inhibitor, on arthritis in patients with systemic lupus erythematosus (SLE) in a post-hoc analysis from the PAISLEY SLE study ( NCT03252587).Methods PAISLEY SLE was a 48-week, global, double-blind, placebo-controlled, phase II study evaluating deucravacitinib (3 mg two times per day), 6 mg two times per day and 12 mg one time per day in SLE. Patients with ≥6 swollen, tender or active (swollen plus tender) joints and those with any joint involvement at baseline were evaluated from weeks 4 to 48. Arthritis efficacy was assessed by 100% reduction (JC-100) or ≥50% reduction (JC-50) from baseline in joint count using non-responder imputation. ORs were calculated using logistic regression. Proportions of patients demonstrating musculoskeletal involvement, as assessed by British Isles Lupus Assessment Group 2004 (BILAG-2004) and Systemic Lupus Erythematosus Disease Activity Index 2000 (SLEDAI-2K) domain scores, were also evaluated.Results More patients achieved JC-100 with deucravacitinib versus placebo whether they had ≥1 or ≥6 tender or active joints at baseline. At week 48, JC-100 active joint responses in patients with ≥6 joints involved were deucravacitinib 3 mg two times per day (n=38/63), 60.3%; 6 mg two times per day (n=26/65), 40.0%; 12 mg one time per day (n=28/62), 45.2%; and placebo (n=20/64), 31.3%. At week 48, ORs for JC-100 for swollen, tender or active joints with deucravacitinib 3 mg two times per day versus placebo were 3.4, 2.0 and 3.3, respectively. Comparable responses and ORs were seen with achievement of JC-50 for swollen, tender or active joints at all deucravacitinib doses. More patients receiving deucravacitinib versus placebo had musculoskeletal score improvements by both BILAG-2004 and SLEDAI-2K at week 48.Conclusion Deucravacitinib was associated with improvements in arthritis in patients in the phase II PAISLEY SLE study. Results will be further evaluated in ongoing phase III studies.

Source: Lupus Science & Medicine

DOI: 10.1136/lupus-2026-002198