Deucravacitinib, an oral, selective, allosteric tyrosine kinase 2 inhibitor, in moderate to severe plaque psoriasis: correlations between patient-reported outcomes and clinical responses in the phase 3 clinical trials POETYK PSO-1 and POETYK PSO-2

In the phase 3 clinical trials POETYK PSO-1 and PSO-2, deucravacitinib was compared for effi cacy and safety with placebo and apremilast in the treatment of patients with moderate to severe plaque psoriasis 1 -Deucravacitinib is an oral, selective, allosteric tyrosine kinase 2 (TYK2) inhibitor approved by the US Food and Drug Administration for the treatment of adults with moderate to severe plaque psoriasis who are candidates for systemic therapy or phototherapy -In each clinical trial, greater proportions of patients who received deucravacitinib achieved ≥75% reduction from baseline in the Psoriasis Area and Severity Index score (PASI 75) 1 and static Physician's Global Assessment scores of 0 or 1 (sPGA 0/1), 1 and showed meaningful improvements on Psoriasis Symptoms and Signs Diary (PSSD) total scores (≥25 points) 2 and Dermatology Life Quality Index (DLQI) total scores (≥4 points) 3 compared with patients receiving placebo or apremilast • In this post hoc analysis of data pooled from both trials, clinical and patient-reported outcomes (PROs) were found to be correlated • When analyzed by the deucravacitinib or placebo treatment arm, greater proportions of patients who received deucravacitinib reported symptom reduction and improved quality of life, both in patients who did and who did not achieve PASI 75 and sPGA 0/1 responses Objective • To explore the correlations between responses on clinical and PRO measures in pooled data from POETYK PSO-1 and PSO-2 Methods • In POETYK PSO-1 (N = 666) and PSO-2 (N = 1020) adults (aged ≥18 years) with moderate to severe psoriasis were randomized 2:1:1 to deucravacitinib 6 mg once daily, placebo, or apremilast 30 mg twice daily -At Week 16 in each trial, patients who received placebo crossed over to deucravacitinib • Using data pooled from both trials, we evaluated the correlation between responses measured by PASI and sPGA on one hand, and the PRO measures PSSD (≥25 points) 2 and DLQI (≥4 points) 3 on the other -The analysis populations for the PSSD and DLQI included all patients from the full analysis set who completed ≥1 item on the respective questionnaire at baseline and ≥1 post-baseline visit • At baseline, 1659 patients had a DLQI score recorded and 1553 had a PSSD score recorded • Spearman correlation coeffi cients between clinical and PRO score changes from baseline to Week 16 were calculated with all treatment groups combined • Mean PSSD and DLQI scores were determined within relative PASI and sPGA response levels • The proportions of patients achieving meaningful improvement (ie, response) in PSSD total scores and on the DLQI were summarized by whether they did or did not achieve PASI 75 and sPGA 0/1, and were further analyzed by treatment arm -Results are reported for patients receiving deucravacitinib or placeboOutcome measures • PASI -Clinician evaluated -Range: 0-72, with higher scores indicating more severe disease • sPGA -Clinician evaluated -Range: 0 (clear) to 4 (severe) • PSSD -Patient rated -5 skin symptoms (itch, tightness, burning, stinging, and pain) and 6 skin signs (dryness, cracking, scaling, shedding/fl aking, redness, and bleeding) associated with psoriasis were rated 0 (absent) to 10 (worst imaginable); averages within each domain were multiplied by 10, then averaged across both domains to obtain a total score -Range: 0-100, with higher scores indicating heavier disease burden • DLQI -Patient rated -10 questions that assess the extent to which skin disease affects patients' lives -Range: 0-30, with higher scores indicating more severe impact of disease Results Correlations between clinical and PRO measures • At Week 16, change from baseline in relative PASI score was correlated with changes in the PSSD total score (Spearman's rank correlation coeffi cient [r s ] = 0.536) and DLQI total score (r s = 0.421) in the total study population • At Week 16, change from baseline in sPGA score was correlated with changes in the PSSD total score (r s = 0.496) and DLQI total score (r s = 0.380) in the total study population • Higher PASI or sPGA response was associated with greater PSSD and DLQI responses at Weeks 16, 24, and 52 in the total study population (Figures 1-4) • This study was sponsored by Bristol Myers Squibb • Medical writing and editorial assistance was provided by Eleanor Bush, MA, of Peloton Advantage, LLC, an OPEN Health company, and funded by Bristol Myers Squibb

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