Phase 2 Trial of Deucravacitinib in Psoriatic Arthritis: Biomarkers Associated With Disease Activity, Pharmacodynamics, and Clinical Responses.

Publication Title

Arthritis Rheumatol

Document Type

Article

Publication Date

5-21-2024

Keywords

washington; swedish

Abstract

OBJECTIVE: To evaluate the association of serum biomarkers with baseline psoriatic arthritis (PsA) disease activity, pharmacodynamic effects of deucravacitinib on biomarker levels, and relationship between biomarkers and clinical responses to deucravacitinib.

METHODS: The phase 2 trial (NCT03881059) randomized 203 patients with PsA 1:1:1 to placebo, deucravacitinib 6 mg once daily (QD), or deucravacitinib 12 mg QD. Serum biomarkers associated with the IL-23 pathway (IL-17A, BD-2, and IL-19), Type I interferon pathway, inflammation, and collagen matrix turnover were measured by immunoassay. Clinical responses (≥75% improvement from baseline in Psoriasis Area and Severity Index [PASI 75] and ≥20% improvement from baseline in American College of Rheumatology [ACR 20] criteria responses) were measured at week 16. Hematologic variables were also assessed.

RESULTS: IL-17A, BD-2, and IL-19 had a modest association with PASI scores (r=0.4, r=0.56, and r=0.5, respectively) at baseline. In deucravacitinib groups, IL-17A, BD-2, IL-19, CXCL-9, CXCL-10, CRP, MMP3, and C4M levels were significantly reduced at week 16 versus baseline (P

CONCLUSION: Deucravacitinib significantly impacted biomarkers associated with TYK2 signaling pathways of key inflammatory cytokines, including IL-23 and Type I IFN, and those related to collagen matrix turnover. These biomarkers may predict treatment responses to deucravacitinib.

Clinical Institute

Orthopedics & Sports Medicine

Specialty

Orthopedics

Specialty

Rheumatology

Specialty

Pharmacy

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