A double-blind, phase II trial published in Annals of the Rheumatic Diseases has reported the efficacy and tolerability of deucravacitinib, a first-in-class, oral, selective tyrosine kinase 2 (TYK2) inhibitor, in patients with active psoriatic arthritis (PsA).
The study carried out by researchers at Swedish Medical Center included 203 PsA patients who were randomized to receive placebo, deucravacitinib 6 mg or 12 mg once a day in 1:1:1 ratio. A significantly higher American College of Rheumatology-20 (ACR-20) response was noted at week 16 for deucravacitinib 6 mg (52.9% and 62.7%, P=0.0134) and 12 mg (p=0.0004) when compared to placebo (31.8%).
In addition, both deucravacitinib doses showed significant improvements in multiplicity-controlled secondary endpoints from baseline in Health Assessment Questionnaire-Disability Index, Short Form-36 Physical Component Summary score and Psoriasis Area and Severity Index-75 response (P ≤0.05).
Moreover, there were no incidence of serious adverse events, herpes zoster, opportunistic infections, major adverse cardiovascular events, and abnormal laboratory parameters in subjects who received deucravacitinib therapy compared to placebo. Nasopharyngitis, upper respiratory tract infection, sinusitis, bronchitis, rash, headache, and diarrhoea were the most common adverse events (≥5%) noted in patients who had undergone deucravacitinib treatment.
Philip J Mease and co-researchers concluded that 6 mg and 12 mg doses of deucravacitinib exhibited a higher efficacy compared to placebo and was well tolerated in PsA patients for a 16-week treatment duration. There are limited choices available for targeted oral therapies in PsA, hence deucravacitinib can be a promising treatment alternative in patients with active disease. Further larger and longer clinical trials are needed to prove the long-term efficacy and safety of deucravacitinib in active PsA patients
Reference: Mease PJ, Deodhar AA, van der Heijde D, Behrens F, Kivitz AJ, Neal J, Kim J, Singhal S, Nowak M, Banerjee S. Efficacy, and safety of selective TYK2 inhibitor, deucravacitinib, in a phase II trial in psoriatic arthritis. Ann Rheum Dis. 2022 Mar 3:annrheumdis-2021-221664.