Efficacy and safety of selective TYK2 inhibitor, deucravacitinib, in a phase II trial in psoriatic arthritis.
Annals of the rheumatic diseases
washington; seattle; swedish
OBJECTIVE: To evaluate the efficacy and safety of an oral selective tyrosine kinase 2 (TYK2) inhibitor, deucravacitinib, in patients with active psoriatic arthritis (PsA).
METHODS: In this double-blind, phase II trial, 203 patients with PsA were randomised 1:1:1 to placebo, deucravacitinib 6 mg once a day or 12 mg once a day. The primary endpoint was American College of Rheumatology-20 (ACR-20) response at week 16.
RESULTS: ACR-20 response was significantly higher with deucravacitinib 6 mg once a day (52.9%, p=0.0134) and 12 mg once a day (62.7%, p
CONCLUSIONS: Treatment with the selective TYK2 inhibitor deucravacitinib was well tolerated and resulted in greater improvements than placebo in ACR-20, multiplicity-controlled secondary endpoints and other exploratory efficacy measures in patients with PsA. Larger trials over longer periods of time with deucravacitinib are warranted to confirm its safety profile and benefits in PsA.
TRIAL REGISTRATION NUMBER: NCT03881059.
Orthopedics & Sports Medicine
Mease, Philip; Deodhar, Atul A; van der Heijde, Désirée; Behrens, Frank; Kivitz, Alan J; Neal, Jeffrey; Kim, Jonghyeon; Singhal, Shalabh; Nowak, Miroslawa; and Banerjee, Subhashis, "Efficacy and safety of selective TYK2 inhibitor, deucravacitinib, in a phase II trial in psoriatic arthritis." (2022). Articles, Abstracts, and Reports. 5898.