All content on this site is intended for healthcare professionals only. By acknowledging this message and accessing the information on this website you are confirming that you are a healthcare professional.

The PsOPsA Hub uses cookies on this website. They help us give you the best online experience. By continuing to use our website without changing your cookie settings, you agree to our use of cookies in accordance with our updated Cookie Policy

Introducing

Now you can personalise
your PsOPsA Hub experience!

Bookmark content to read later

Select your specific areas of interest

View content recommended for you

Find out more
  TRANSLATE

The PsOPsA Hub website uses a third-party service provided by Google that dynamically translates web content. Translations are machine generated, so may not be an exact or complete translation, and the PsOPsA Hub cannot guarantee the accuracy of translated content. The PsOPsA Hub and its employees will not be liable for any direct, indirect, or consequential damages (even if foreseeable) resulting from use of the Google Translate feature. For further support with Google Translate, visit Google Translate Help.

Steering CommitteeAbout UsNewsletterContact
LOADING
You're logged in! Click here any time to manage your account or log out.
LOADING
You're logged in! Click here any time to manage your account or log out.

The PsOPsA Hub is supported by educational grants. All educational content is developed independently by SES in collaboration with our expert steering committee, with no input or influence from financial supporters. We would like to express our gratitude to the following companies for their support: • UCB: For website development, launch, and ongoing maintenance. • UCB and Bristol Myers Squibb: For educational content and news updates.

2024-07-01T15:24:21.000Z

Deucravacitinib vs apremilast and placebo for treatment of moderate-to-severe plaque psoriasis: The POETYK-PSO-2 trial

Jul 1, 2024
Share:
Learning objective: After reading this article, learners will be able to cite a new clinical development in plaque psoriasis treatment.

Given the safety and tolerability profiles of currently available biologics and small-molecule oral agents for plaque psoriasis, there is a need for novel, better-tolerated therapies. Deucravacitinib is an oral, selective tyrosine kinase 2 (TYK2) inhibitor that binds to the regulatory or pseudokinase domain of TYK2 and allosterically inhibits the enzyme from initiating cytokine synthesis and plaque psoriasis pathogenesis. 

Here, we summarize the results of POETYK-PSO-2, a phase III, randomized, double-blind study assessing the efficacy and safety of deucravacitinib against apremilast and placebo for the treatment of moderate-to-severe plaque psoriasis (NCT03611751),1 published in the Journal of the American Academy of Dermatology by Strober et al.

Methods1

  • POETYK PSO-2 trial was a 52-week, double-blinded, phase III study conducted across 191 sites in 16 countries between June 2018 and November 2019, and included 1,020 adult patients with moderate-to-severe plaque psoriasis and:
    • Psoriasis Area and Severity Index (PASI) ≥12; 
    • static Physician’s Global Assessment (sPGA) ≥3; and 
    • body surface area involvement ≥10% for ≥6 months.
  • Patients were randomized to deucravacitinib 6 mg every day (n = 511), placebo (n = 255), or apremilast 30 mg twice a day (n = 254).
  • The coprimary efficacy endpoints at Week 16, for patients treated with deucravacitinib vs placebo, were:
    • ≥75% reduction from baseline in PASI (PASI 75); and 
    • sPGA score of 0 (clear) or 1 (almost clear), with a ≥2-point improvement from baseline (sPGA 0/1). 
  • Secondary endpoints included Week 16 PASI 90, PASI 100, sPGA 0 vs placebo, and Week 24 PASI 90 vs apremilast.

Key findings1

  • More patients who received deucravacitinib achieved the coprimary endpoints of PASI 75 and sPGA 0/1 at Week 16 than patients who received apremilast or placebo (Figure 1).
  • Deucravacitinib was also associated with higher PASI 90, PASI 100, and sPGA 0 responses at Week 16 and a higher PASI 90 vs apremilast at Week 24.
  • Rates of adverse events (AEs) and serious AEs were similar in patients who received deucravacitinib and those who received apremilast; the most common AEs were nasopharyngitis and upper respiratory tract infections in the deucravacitinib group, and headache, diarrhea and nausea in the apremilast group. 

Figure 1. Efficacy measures at the end of Week 16* 

BID, twice daily; PASI, Psoriasis Area and Severity Index; QD, once daily; sPGA, static Physician’s Global Assessment.
*Data from Strober, et al.

 

Key learnings

Deucravacitinib demonstrated clinically significant efficacy over placebo and apremilast in adults with moderate-to-severe plaque psoriasis over 52 weeks.

Deucravacitinib was generally well tolerated, with a safety profile consistent with the mechanism of selective TYK2 inhibition, showing low rates of serious AEs.

This trial suggests that deucravacitinib may be a viable oral, once-daily treatment option for patients with plaque psoriasis, although longer-term data are needed.

  1. Strober B, Thaçi D, Sofen H, et al. Deucravacitinib versus placebo and apremilast in moderate to severe plaque psoriasis: Efficacy and safety results from the 52-week, randomized, double-blinded, phase 3 Program fOr Evaluation of TYK2 inhibitor psoriasis second trial. J Am Acad Dermatol. 2023;88(1):40-51. DOI: 10.1016/j.jaad.2022.08.061

Your opinion matters

HCPs, what is your preferred format for educational content on the PsOPsA Hub?
9 votes - 65 days left ...

Newsletter

Subscribe to get the best content related to Psoriasis and Psoriatic Arthritis delivered to your inbox