Deucravacitinib shows strong phase 3 results in plaque psoriasis
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Deucravacitinib was associated with improved efficacy and safety compared with both placebo and apremilast in a phase 3 cohort of adults with moderate to severe plaque psoriasis, according to a study.
In an interview with Healio, April W. Armstrong, MD, MPH, of the department of dermatology at Keck School of Medicine at the University of Southern California, Los Angeles, explained the rationale for the study design.
“This study included a comparison to apremilast (Otezla, Amgen) because apremilast is a commonly used oral medication for psoriasis and psoriatic arthritis,” Armstrong said. “Therefore, the study included a clinically relevant comparator from the real-world practice.”
The analysis included 332 patients treated with deucravacitinib (Bristol Myers Squibb), an oral, selective tyrosine kinase 2 (TYK2) inhibitor, at a dose of 6 mg once daily; 166 patients assigned placebo; and 168 patients assigned apremilast at a dose of 30 mg twice daily. The double-blind study had a follow-up duration of 52 weeks.
The coprimary endpoints were a 75% or greater reduction in PASI from baseline and a static PGA score of 0 or 1 (sPGA 0/1) of deucravacitinib compared with placebo at week 16.
Results at week 16 showed PASI 75 response rates of 58.4% for deucravacitinib compared with 12.7% for placebo and 35.1% for apremilast ( P < .0001).
A similar trend was observed for sPGA 0/1, with 53.6% of patients in the deucravacitinib group reaching this endpoint, compared with 7.2% in the placebo group and 32.1% in the apremilast group ( P < .0001).
Efficacy persisted between weeks 16 and 52 of therapy, according to the findings.
Regarding safety, adverse events were reported in 2.1% of patients in the study drug arm, 5.5% of those in the placebo arm and 2.4% in the apremilast arm.
Focusing on adverse events of interest, the researchers reported that skin events, herpes zoster, serious infections, malignancies and cardiovascular outcomes occurred at low rates in all groups.
“Deucravacitinib performed very well as a new oral agent for psoriasis,” Armstrong said. “It is superior to apremilast on multiple endpoints related to psoriasis and skin-related quality of life.”
The researchers noted limited racial diversity of the patient population as a key limitation of the findings, along with the study duration of 1 year.
“Deucravacitinib is a breakthrough innovation in oral therapy for psoriasis,” Armstrong said. “It provides robust clinical efficacy that is superior to apremilast and similar to that of first-generation biologics. It also has a favorable safety profile. Therefore, I anticipate that deucravacitinib will likely become a leading oral therapy for patients with psoriasis.”
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