New 3-Year Data Released on PASI Outcomes for Psoriasis Patients on Deucravacitinib

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These study findings, presented at AAD 2024, were the results of a recent analysis conducted to assess long-term outcomes among patients with psoriasis.

Linda Stein Gold, MD

Credit: Henry Ford Health System

Linda Stein Gold, MD

Credit: Henry Ford Health System

Individuals with plaque psoriasis treated with continuous deucravacitinib for up to 3 years show clinically-significant responses in their Psoriasis Area and Severity Index (PASI) scores, according to recent findings.1,2

These long-term findings were presented at the 2024 American Academy of Dermatology (AAD) Annual Meeting in San Diego, California. The research was led by Linda Stein Gold, vice president of the American Academy of Dermatology and head of Henry Ford Health System’s division of dermatology.

In the US, Europe, and several other countries, patients with diagnoses of moderate-to-severe psoriasis are now afforded the opportunity to access deucravacitinib provided they qualify for systemic therapy. The drug’s effectiveness and tolerability among patients was established after the global, phase 3, 52-week POETYK PSO-1 and PSO-2 studies.

POETYK PSO-1 and POETYK PSO-2 had been conducted worldwide and had compared deucravacitinib to placebo and to apremilast. The studies had been multicenter, randomized, double-blinded trials and involved the assessment of 666 and 1,020 patients in the aforementioned cohorts, respectively.

The participants had been randomly assigned in a 1:2:1 ratio to either be given oral placebo, once-per-day deucravacitinib 6 mg, or twice-per-day apremilast 30 mg. After the 52-week mark, subjects were provided the option to enter the POETYK long-term extension trial and be given deucravacitinib openly.

Stein Gold and colleagues’ analysis involved an evaluation of 513 individuals who had been on continuous deucravacitinib treatment from the initial day of the first studies up through to 3 years at the 148-week mark. The research team’s criteria for their assessment, in part, involved looking at the mean change from participants’ baseline PASI score.

The team made the decision to implement modified baseline observation which was carried forward. Another outcome they assessed was the percentage of individuals who were shown to reach their predefined absolute PASI score thresholds.

The investigators noted a mean (SD) baseline PASI score of 21.1 (7.9), adding that improvements in participants’ conditions were beginning to appear even at the first week. They highlighted the PASI scores’ mean change of −3.2 (4.9) and that it progressed through to the 16-week mark with a change of −15.7 (9.0).

These noticeable improvements were observed to have been enhanced further −17.6 (8.0) by the 52-week mark. The research team expressed that this progress continued up to the 148-week mark with a mean change of −16.4 (8.7).

The percentages of subjects who were shown to have reduced their PASI scores by 75-80% from the point of baseline, 80-85%, 85-90%, 90-95%, and 95-100% were noted as having met the predefined absolute PASI thresholds of ≤1, ≤2, ≤3, ≤4, and ≤5.

Additionally, these same subjects were found by the investigators to have met the absolute PASI of >1 to ≤3 and >3 to ≤5, with these individuals either seeing increases or continued stability from the 16 through the 52-week mark and then through to the 3-year mark.

Overall, the investigators’ outcomes, with regard to efficacy as determined by PASI scores and success in treat-to-target thresholds, were shown to be clinically significant by the investigators over the course of 3-year treatment with continuous deucravacitinib therapy.

References

  1. Stein Gold L, et al. Deucravacitinib, an oral, selective, allosteric tyrosine kinase 2 inhibitor, in plaque psoriasis: 3-year Psoriasis Area and Severity Index (PASI) outcomes in the long-term extension of the phase 3 POETYK PSO-1 and PSO-2 trials. Presentation (Poster #51091) at the American Academy of Dermatology (AAD) 2024 Annual Meeting. March 2024.
  2. Armstrong AW, et al. Deucravacitinib versus placebo and apremilast in moderate to severe plaque psoriasis: efficacy and safety results from the 52-week, randomized, double-blinded, placebo-controlled phase 3 POETYK PSO-1 trial. J Am Acad Dermatol. 2023;88:29-39.
  3. Strober B, 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;88:40-51.
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