AB1086 COVID-19–RELATED ADVERSE EVENTS IN THE PHASE 3 POETYK TRIALS OF THE ALLOSTERIC TYROSINE KINASE 2 INHIBITOR, DEUCRAVACITINIB, IN PATIENTS WITH MODERATE TO SEVERE PLAQUE PSORIASIS

Abstract

Aim: Deucravacitinib is approved in the US, Australia, and other countries for the treatment of adults with moderate‐to‐ severe plaque psoriasis who are candidates for systemic therapy or phototherapy. The aim of this study was to evaluate the incidence and severity of adverse events due to COVID‐19 in patients treated with deucravacitinib, an oral, selective, allosteric tyrosine kinase 2 inhibitor, in the phase 3 POETYK trials. Methods: In the POETYK PSO‐1 and PSO‐2 trials, adults with moderate to severe plaque psoriasis were randomised 1:2:1 to placebo, deucravacitinib 6 mg once daily, or apremilast 30 mg twice daily. Following completion of PSO‐1 or PSO‐2, patients could enrol in the POETYK long��term extension (LTE) trial and receive open‐label deucravacitinib. The trials all coincided with the COVID‐19 pandemic. Results: The incidence rates and severity of COVID‐19‐ related adverse events (AEs) in the combined POETYK trials (n = 1364; 2076.7 person‐years [PY] of follow‐up) were compared with the Janssen/Johnson & Johnson COVID‐19 vaccine trial placebo group (n = 19,544; 3096.1 PY of follow‐up). A total of 153 deucravacitinib patients reported a COVID‐19‐ related AE (exposure‐adjusted incidence rate [EAIR], 7.4/100 PY; 95% CI, 6.2‐8.6). Serious COVID‐19‐ related AEs occurred in 43 patients (EAIR, 2.1/100 PY; 95% CI, 1.5‐2.8); this rate was within the rates for moderate to severe COVID‐19 reported in the reference population (EAIR, 16.5/100 PY; 95% CI, 15.0‐17.9). Deaths due to COVID‐19 occurred in 6 patients (EAIR, 0.3/100 PY; 95% CI, 0.1‐0.6), consistent with the reference population (EAIR, 0.23/100 PY; 95% CI, 0.1‐0.5). Treatment was discontinued due to COVID‐19 or COVID‐19 pneumonia in 7 patients, including 6 deaths. Most infections were not serious and did not lead to treatment discontinuation. Conclusions: Based on this analysis, deucravacitinib did not appear to increase the risk of COVID‐19 nor its progression to severe outcomes.