Deucravacitinib: Laboratory Parameters Across Phase 3 Plaque Psoriasis Trials

Area of Science:

• Dermatology
• Pharmacology
• Clinical Trials

Background:

• Deucravacitinib is an approved oral, selective, allosteric tyrosine kinase 2 inhibitor for moderate to severe plaque psoriasis.
• Previous trials (POETYK PSO-1 and PSO-2) demonstrated its superiority to placebo and apremilast with good tolerability.
• This analysis focuses on the long-term effects of deucravacitinib on laboratory parameters in patients continuing treatment in the POETYK LTE trial.

Purpose of the Study:

• To evaluate the long-term effects of deucravacitinib on laboratory parameters over a 3-year period.
• To assess the incidence and severity of laboratory adverse events (AEs) associated with deucravacitinib treatment.
• To determine the rate of discontinuations due to laboratory AEs.

Main Methods:

• Analysis of data from the 52-week, phase 3, double-blinded POETYK PSO-1 and PSO-2 trials, and the subsequent open-label POETYK LTE trial.
• Patients received deucravacitinib 6 mg once daily or apremilast 30 mg twice daily (in initial trials).
• Evaluation of mean changes from baseline in laboratory parameters, laboratory AEs, and discontinuations due to laboratory AEs over 3 years.

Main Results:

• No clinically relevant mean changes in laboratory parameters were observed over 3 years in 1519 patients exposed to deucravacitinib.
• Grade ≥3 laboratory AEs were infrequent and remained stable over the 3-year treatment period.
• Most laboratory AEs remained at the same grade, with infrequent shifts to higher grades (≤2), and rare discontinuations due to laboratory AEs.

Conclusions:

• Deucravacitinib treatment did not lead to clinically meaningful changes in laboratory parameters over 3 years.
• The safety profile regarding laboratory parameters is favorable, even when compared to Janus kinase (JAK) inhibitors.
• Laboratory AEs, including severe ones and treatment discontinuations, were rare.