- Lebwohl M. Deucravacitinib long-term efficacy with continuous treatment in plaque psoriasis: 2-year results from the phase 3 POETYK PSO study program. D3T01.1F, EADV Congress 2022, Milan, Italy, 7–10 September.
In the pivotal POETYK-PSO-1 trial (NCT03624127), patients were treated in a placebo-controlled fashion from day 1 to week 16, after which placebo patients were able to cross over to active deucravacitinib, given at a dose of 6 mg once daily (approved dose). At the pivotal primary endpoint, 58.4% of the patients treated with deucravacitinib achieved PASI75 compared with 12.7% of the placebo-treated patients. This rate further rose to 69.3% at week 24 and 65.1% after 1 year. At the same time points, the results for the static Physician's Global Assessment (sPGA) of 0/1 were within a similar range: 53.6%, 58.7%, and 52.7%, respectively.
At EADV 2022, Prof. Mark Lebwohl (Icahn School of Medicine at Mount Sinai, NY, USA) presented the 112-week extension data on deucravacitinib1. Included in the analysis were the longer-term outcomes of all patients, who received the active drug from day 1 of the trial, with special focus on the PASI75 responders at week 16, who entered the open-label extension after week 52.
Of the 332 patients who were initially randomised to deucravacitinib in POETYK-PSO1, 265 continued in the long-term extension after week 52 and 173 among them reached PASI 75 at week 16. Baseline data of these 2 groups varied somewhat with mean values for age of 46 years and 45.2 years, weight 87.0 kg and 84.7 kg, PASI 21.8 and 22.6, and sPGA 3 in 78.5% and 74.6%.
Independent of missing data imputation, the PASI 75 outcomes for the cohort with all patients on continuous deucravacitinib resulted in a rather horizontal graph. Prof. Lebwohl stressed that imputation according to “as observed“ or “treatment failure rules” did lead to hardly any change in the results, which he saw as characteristic of a very effective treatment. The outcomes with a modified non-responder imputation (mNRI) went from of 80.2% at week 52 to 82.4% at week 112. The maintenance result for PASI 75 responders at week 16 that started at 90.1% in week 52, attained 91.0% at week 112. sPGA 0/1 was achieved by 66.5% of all extension patients at week 112 and by 73.5% of the 16-week responders.
“So, now we have a once-daily, oral drug with efficacy similar to biologic agents,” Prof. Lebwohl concluded.