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2024-02-26T14:03:55.000Z

POETYK LTE trial: 2 year follow-up of deucravacitinib in plaque psoriasis

Feb 26, 2024
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Learning objective: After reading this article, learners will be able to cite a new clinical development in psoriasis.

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Deucravacitinib, an oral TYK2 inhibitor, has shown promising survival results and a manageable safety profile in patients with moderate to severe plaque psoriasis in POETYK PSO-1 and PSO-2 clinical trials. Here, we summarize the latest follow-up data from the POETYK LTE trial published by Lebwohl M et al1 in British Journal of Dermatology investigating long-term results and durability of deucravacitinib from the above two trials.

Study design

  • POETYK LTE (NCT04036435) is a phase 3, ongoing extension trial (N=1519)
  • The primary endpoint was safety assessed as exposure-adjusted incidence rates (EAIR) of adverse events (AE)
  • Efficacy was measured as 75% reduction from baseline in the Psoriasis Area and Severity Index (PASI 75) and static Physician Global Assessment (sPGA)
  • Mean age of patients was 46.6 years

Key findings

  • EAIRs of AEs, serious adverse events and AEs resulting in treatment discontinuation were reported lower when assessed over 2 years compared with 1 year (Table 1)
  • The most reported adverse events over the 2 year follow-up were:
    • Nasopharyngitis (12.9/100 person years (PY))
    • Upper respiratory tract infections (6.5/100 PY) and;
    • COVID-19 (5.1/PY)
  • In total, 10 deaths were reported in the 2-year period and 6 related to COVID-19
    • Patients were not fully vaccinated from COVID-19 and were 50 years

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

AE category, EAIR/ 100 PY

POETYK PSO-1 and PSO-2 trials through year 1, n = 1,364

POETYK PSO-1, PSO-2 and LTE through 2 years, n = 1,519

AE

229.2

154.4

SAE

5.7

6.1

Discontinued treatment

4.4

2.8

AE, adverse event; SAE, serious adverse event; EAIR, exposure-adjusted incidence rates; LTE, long-term extension; PY, person years.

*Adapted from Lebwohl, et al.1


Key learnings

  • Efficacy and safety results from long term data 2-years after trial initiation were consistent with results 1-year after initiation
  • Deucravacitinib remains a safe and efficacious long-term treatment option for patients with moderate to severe plaque psoriasis
  • COVID-19 vaccination provides protection from infection in patients receiving deucravacitinib treatment

  1. Lebwohl M, Warren RB, Sofen H, et al. Deucravacitinib in plaque psoriasis: 2-year safety and efficacy results from the phase 3 POETYK trials. Br J Dermatol. 2024;190(5):668-679.  DOI: 10.1093/bjd/ljae014

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