The US Food and Drug Administration has approved deucravacitinib (Sotyktu) for the treatment of adults with active psoriatic arthritis, introducing the first and only tyrosine kinase 2 (TYK2) inhibitor authorized for this indication, according to a press release from Bristol Myers Squibb.
The once-daily oral therapy improved disease activity outcomes vs placebo in two phase 3 randomized controlled trials.
The approval was based on findings from the pivotal POETYK PsA-1 and POETYK PsA-2 trials, which evaluated deucravacitinib 6 mg once daily in adults with active psoriatic arthritis (PsA). Both multicenter, randomized, double-blind, placebo-controlled studies assessed treatment response at Week 16 using the American College of Rheumatology 20% improvement criteria (ACR20) as the primary endpoint.
In POETYK PsA-1, an ACR20 response was achieved by 54% of patients receiving deucravacitinib compared with 34% of patients who received placebo. In POETYK PsA-2, an ACR20 response was observed in 54% of patients receiving deucravacitinib vs 39% receiving placebo.
Additional endpoints also favored deucravacitinib. In POETYK PsA-1, ACR50 responses occurred in 24% of patients receiving deucravacitinib compared with 14% receiving placebo, while ACR70 responses occurred in 12% vs 5%, respectively. In POETYK PsA-2, ACR50 responses occurred in 29% of patients receiving deucravacitinib compared with 16% receiving placebo, and ACR70 responses occurred in 10% vs 5%. Minimal disease activity, a key secondary endpoint, was also achieved by a greater proportion of patients receiving deucravacitinib across both trials.
The phase 3 program enrolled adults aged 18 years or older with active PsA who had at least three swollen joints, three tender joints, and an active or documented history of plaque psoriasis. POETYK PsA-1 included 670 patients who had not previously received biologic disease-modifying antirheumatic drugs. POETYK PsA-2 included 624 patients, including those with prior tumor necrosis factor inhibitor exposure. Both trials included a placebo-controlled period through Week 16 followed by continued treatment through Week 52.
Deucravacitinib selectively targets tyrosine kinase 2 signaling involved in interleukin-23, interleukin-12, and type 1 interferon pathways implicated in PsA. The drug binds to the regulatory domain of TYK2, resulting in allosteric inhibition and modulation of downstream signaling.
The safety profile observed in patients with PsA was generally consistent with findings previously reported in plaque psoriasis studies. The most common adverse reactions occurring in at least 1% of patients receiving deucravacitinib and more frequently than placebo included upper respiratory infections, increased creatine phosphokinase, herpes simplex, mouth ulcers, folliculitis, and acne.
Source: Bristol Myers Squibb