Deucravacitinib superior to placebo, apremilast in phase 3 plaque psoriasis trials
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Deucravacitinib showed significant improvement in plaque psoriasis compared with both placebo and apremilast, according to two studies presented at AAD VMX 2021.
“Deucravacitinib is a novel, oral, selective TYK2 inhibitor, which is unique in that it binds to the TYK2 regulatory domain with high selectivity,” April Armstrong, MD, MPH, of the Keck School of Medicine at the University of Southern California, Los Angeles, said.
The phase 3 POETYK PSO-1 and POETYK PSO-2 trials, which were identical in design through week 24, randomly assigned patients 2:2:1 to receive once-daily deucravacitinib 6 mg, placebo or twice-daily apremilast 30 mg.
Psoriasis Area and Severity Index 75 response was reported in 58.7% and 53.6% of patients receiving deucravacitinib compared with 12.7% and 9.4% in the placebo groups and 35.1% and 40.2% in the apremilast groups at week 16.
The deucravacitinib groups achieved PASI 75 response in 69% and 59.3% of patients at week 24 compared with 38.1% and 37.8% of those taking apremilast.
“More than 80% of deucravacitinib patients who achieved PASI 75 at week 24 and continued treatment maintained PASI 75 response at week 52 in both studies,” Armstrong said.
In addition, static Physician’s Global Assessment score of 0/1 was recorded by 53.6% and 50.3% of those taking deucravacitinib at week 16 compared with 7.2% and 8.6% in the placebo groups and 32.1% and 34.3% in the apremilast groups.
At week 24, the deucravacitinib groups had an sPGA 0/1 response of 58.4% and 50.4% compared with 31% and 29.5% in the apremilast groups.
Across both studies, adverse events at week 16 were reported in 49.6% of the placebo group, 55.7% of the deucravacitinib group and 57.6% of the apremilast group, with serious adverse events in 2.9% of the placebo group, 1.8% of the deucravacitinib group and 1.2% of the apremilast group.
“Based on these findings, deucravacitinib has the potential to become an efficacious and well-tolerated treatment of choice for patients with moderate to severe plaque psoriasis,” Armstrong said.