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Peer-reviewedCC BY-NC 4.0Lupus Science & Medicine

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

8 affiliations
  1. 1Rheumatology, MedPharm Consulting Inc, Bethesda, Maryland, USA
  2. 2Department of Medicine, Division of Rheumatology, NYU Grossman School of Medicine, New York, New York, USA
  3. 3Rheumatology, Northwell Health, Great Neck, New York, USA
  4. 4Department of Medicine, The University of Queensland, Brisbane, Queensland, Australia
  5. 5Charité University Hospital Berlin, Berlin, Germany
  6. 6Bristol Myers Squibb, Princeton, New Jersey, USA
  7. 7Arthritis & Clinical Immunology Program, Oklahoma Medical Research Foundation, Oklahoma City, Oklahoma, USA
  8. 8The University of Oklahoma Health Sciences Center, Oklahoma City, Oklahoma, USA

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.

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BibTeX
@article{pike2026impact,
  title = {{Impact of deucravacitinib on arthritis in patients with systemic lupus erythematosus: results from the phase II PAISLEY SLE study}},
  author = {Marilyn Pike and Amit Saxena and Richard A Furie and Peter Nash and Thomas Dörner and Coburn Hobar and Samantha Pomponi and Ying-Ming Jou and Subhashis Banerjee and Thomas Wegman and Joan T Merrill},
  journal = {Lupus Science \& Medicine},
  year = {2026},
  month = oct,
  doi = {10.1136/lupus-2026-002198},
  url = {https://doi.org/10.1136/lupus-2026-002198},
  note = {CC BY-NC 4.0},
}
RIS
TY  - JOUR
TI  - Impact of deucravacitinib on arthritis in patients with systemic lupus erythematosus: results from the phase II PAISLEY SLE study
AU  - Marilyn Pike
AU  - Amit Saxena
AU  - Richard A Furie
AU  - Peter Nash
AU  - Thomas Dörner
AU  - Coburn Hobar
AU  - Samantha Pomponi
AU  - Ying-Ming Jou
AU  - Subhashis Banerjee
AU  - Thomas Wegman
AU  - Joan T Merrill
PY  - 2026
DA  - 2026/10/29
JO  - Lupus Science & Medicine
DO  - 10.1136/lupus-2026-002198
UR  - https://doi.org/10.1136/lupus-2026-002198
AB  - 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.
SN  - 2053-8790
ER  -