POETYK LTE trial: 2-year follow-up of deucravacitinib for the treatment of plaque psoriasis

In the 52-week, phase III POETYK PSO-1 and PSO-2 clinical trials, treatment with deucravacitinib, an oral TYK2 inhibitor, was associated with promising survival results and a manageable safety profile in patients with moderate-to-severe plaque psoriasis. Here, we summarize the latest data from POETYK LTE, an ongoing open-label long-term extension (LTE) trial of PSO-1 and PSO-2, published by Lebwohl M et al.¹ in British Journal of Dermatology.

Study design

• POETYK LTE (NCT04036435) is an ongoing phase III extension trial of the completed PSO-1 and PSO-2 clinical trials, in which adults with moderate-to-severe plaque psoriasis receive deucravacitinib 6 mg once daily.
• The primary endpoint in the LTE is safety, assessed using exposure-adjusted incidence rates (EAIRs) of adverse events (AEs).
• Secondary endpoints include efficacy, which is measured by a ≥75% reduction from baseline in the Psoriasis Area and Severity Index (PASI 75), PASI 90, and static Physician Global Assessment (sPGA). 

Key findings

• In the LTE, 1,519 patients received ≥1 dose of deucravacitinib over a 2-year period. 
• EAIRs of AEs, serious AEs, and AEs resulting in treatment discontinuation over 2 years were lower than or comparable to the 1-year rates assessed in PSO-1 and PSO-2 (Table 1).
• The most reported AEs over the 2-year follow-up were:
  • Nasopharyngitis (12.9/100 person-years);
  • Upper respiratory tract infections (6.5/100 person-years); and
  • COVID-19 (5.1/100 person-years).
• In total, 10 deaths were reported in the 2-year period.
  • Of these, 6 were related to COVID-19 in patients who had risk factors for severe disease, were not fully vaccinated against COVID-19, and were aged ≥50 years.
• Incidences of AEs of interest (based on the mechanism of action of deucravacitinib) included select infections (such as herpes zoster), major adverse cardiovascular events, venous thromboembolic events, and malignancies and were comparable during the 2-year and 1-year periods.
• The EAIRs of serious infections were numerically higher during the 2-year vs 1-year period, primarily due to COVID-19 infections.
  • The majority of COVID-19 infections over the 2-year period occurred in patients who were unvaccinated.

 Table 1. Overall safety results in Year 1 compared with Year 2*

• Long-term treatment with deucravacitinib maintained or improved efficacy in patients up to Week 112 compared with the start of the extension trial (Week 52):
  • PASI 75: 79.7% vs 72.4%, respectively.
  • PASI 90: 51.5% vs 45.8%, respectively.
  • sPGA 0/1: 61.1% vs 57.9%, respectively.