Analysis: Deucravacitinib Shows Sustained Efficacy and Safety Over Four Years


A new analysis suggested that deucravacitinib showed acceptable safety and efficacy over the course of 4 years of treatment. 

The POETYK PSO-1 and PSO-2 trials, upon which the analysis was based, randomized patients in (1:2:1) to receive placebo, deucravacitinib 6 mg once daily (QD), or apremilast 30 mg twice daily (BID). Patients completing the trials had the option to enroll in a long-term extension (LTE) study where they received open-label deucravacitinib 6 mg QD from Week 52 onwards. Safety assessments included patients who received at least one dose of deucravacitinib, with adverse events (AEs) evaluated using exposure-adjusted incidence rates (EAIR) per 100 person-years (PY). The efficacy outcomes of interest were the achievement of PASI 75, PASI 90, and sPGA 0/1 scores, analyzed using modified non-responder imputation (mNRI) in patients continuously treated with deucravacitinib from the start of the parent trials. 

According to the results, 1,519 participants received ≥1 deucravacitinib dose. Clinical response rates were sustained from year 3 to year 4 in the deucravacitinib group. The proportion of patients achieving PASI 75 scores was 73.8% at Year 3 and 71.7% at year 4. PASI 90 rates were 49.0% at Year 3 and 47.5% at year 4. sPGA 0/1 rates were 55.2% at Year 3 and 57.2% at Year 4. A total of 1519 patients received at least one dose of deucravacitinib, with a cumulative exposure of 4392.8 PY. EAIRs per 100 PY showed a decrease or stabilization from the first to the fourth cumulative year. Overall AE rates were decreased or comparable from year 3 to year 4 [AEs (229.2, 131.7), serious AEs (5.7, 5.0), deaths (0.2, 0.3), discontinuations due to AEs (4.4, 2.2), herpes zoster (0.8, 0.6), malignancies (1.0, 0.9), major adverse cardiovascular events (MACE) (0.3, 0.3), and venous thromboembolism (0.2, 0.1)].

"Deucravacitinib demonstrated durable efficacy with continuous treatment and a safety profile through 4 years consistent with that at 3 years, without new or long-term safety signals," the authors concluded. 

The study was published in the Journal of Dermatology for Physician Assistants

Source: Armstrong A, et al. Journal of Dermatology for Physician Assistants. 2024. Doi:10.1097/jdpa.0000000000000020

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