Deucravacitinib Effective for Patients With Active Psoriatic Arthritis
By Louise Gagnon
OTTAWA, Ontario -- November 12, 2020 -- Deucravacitinib was effective, compared with placebo, over 16 weeks of treatment in patients with active psoriatic arthritis (PsA), according to a study presented at the 2020 Virtual Meeting of the American College of Rheumatology (ACR).
“The effectiveness of this therapy was very good,” said Philip Meiser, MD, the University of Washington School of Medicine, Seattle, Washington. “One of the important cytokines that TYK2 [tyrosine kinase 2] inhibits is IL-23. This is one of the reasons it has shown a very good effect on skin.”
Deucravacitinib (BMS-986165) is a novel oral agent that selectively inhibits TYK2 through an allosteric mechanism by binding to the regulatory domain of TYK2, in contrast to inhibitors of the closely related Janus kinases that bind to the active site in the kinase domain.
The current ongoing, 1-year, randomized, double-blind, multicentre phase 2 trial included patients with a PsA diagnosis for ≥6 months, had active disease (≥3 tender and ≥3 swollen joints), C-reactive protein ≥3 mg/L, and ≥1 psoriatic lesion (≥2 cm).
All patients had failed or were intolerant to ≥1 nonsteroidal anti-inflammatory drug, corticosteroid, and/or conventional synthetic disease-modifying antirheumatic drug, or 1 tumour necrosis factor (TNF) inhibitor.
Patients were randomised 1:1:1 to deucravacitinib 6 mg once daily or 12 mg one daily, or placebo. Of the 203 patients, 180 completed 16 weeks of treatment.
The primary endpoint of ACR 20 response at week 16 was achieved by 52.9% of patients in the deucravacitinib 6 mg arm, by 62.7% of patients in the deucravacitinib 12 mg arm, and by 31.8% of patients in the placebo group.
Prior exposure to a TNF inhibitor did not preclude response to deucravacitinib, noted Dr. Mease.
The majority of adverse events were mild or moderate and consisted of headache, sinusitis, rash, and nasopharyngitis. No cases of herpes zoster were reported and no thrombotic events occurred.
Funding for this study was provided by Bristol Myers Squibb.
[Presentation title: Efficacy and Safety of Deucravacitinib (BMS-986165), an Oral, Selective Tyrosine Kinase 2 Inhibitor, in Patients With Active Psoriatic Arthritis: Results From a Phase 2, Randomized, Double-Blind, Placebo-Controlled Trial. Abstract L03]