A Randomized, Double-Blind, Placebo-Controlled, Twelve-Week, Dose-Ranging Study of Decernotinib, an Oral Selective JAK-3 Inhibitor, as Monotherapy in Patients With Active Rheumatoid Arthritis
Decernotinib (VX-509; Vertex Pharmaceuticals Incorporated) is a JAK 3 inhibitor currently under investigation for its potential use in the treatment of RA. The potency and selectivity profiles of this oral compound have already been established in previous trials, so this study aimed to establish the efficacy and safety profiles of the drug, in RA patients who have had an inadequate response to at least one DMARD.
Four doses; 25 mg, 50 mg, 100 mg and 150 mg, were evaluated in this placebo-controlled study, with efficacy of each dose evaluated by ACR20 and DAS28-CRP at 12 weeks. Clinical signs and symptoms of RA were improved with the higher doses of decernotinib (50 mg, 100 mg and 150 mg) at the end of the study period, but infections and increases in liver transaminase and lipid levels were noted as potential safety signals.
Altogether, this data provides a rationale for further assessing the effect of decernotinib in patients with RA.