FormalPara Key Summary Points

Psoriasis is a chronic, systemic inflammatory disease characterized by skin lesions and other bothersome symptoms that often impact work productivity, psychosocial well-being, and quality of life (i.e., how a patient feels and functions). Consideration of patient-reported outcomes is recommended when selecting an appropriate treatment.

This study compared the effects of deucravacitinib on patient-reported outcomes in patients with moderate-to-severe psoriasis versus the effects of placebo and apremilast.

This study found that, compared with patients receiving placebo or apremilast, patients receiving deucravacitinib reported greater improvement in patient-reported measures of sign and symptom severity and quality of life and were more likely to achieve meaningful within-patient change thresholds on these outcome measures (i.e., they were more likely to report a meaningful improvement).

Deucravacitinib was more effective than placebo or apremilast at improving psoriasis symptoms and signs and improving quality of life, as measured by patient-reported outcomes.

Introduction

Psoriasis is a chronic, systemic, immune-mediated inflammatory disease characterized by skin lesions and other bothersome symptoms, such as scaling, redness, and itching [1], that often result in impairments in work productivity, psychosocial well-being, and quality of life (QoL) [2,3,4]. With this in mind, treatment goals should prioritize the patient’s perspective and aim to improve QoL; thus, consideration of patient-reported outcomes (PROs) is recommended when selecting an appropriate treatment [5, 6]. Current treatments for patients with moderate-to-severe psoriasis include biologic therapies and oral systemic treatments.

Deucravacitinib, an oral, selective, allosteric tyrosine kinase 2 (TYK2) inhibitor, is approved in the US, European Union, and other countries for the treatment of adults with moderate-to-severe plaque psoriasis who are candidates for systemic therapy. Findings from the pivotal phase 3 Program fOr Evaluation of TYK2 inhibitor (POETYK) psoriasis (PSO)-1 (NCT03624127) and POETYK PSO-2 (NCT03611751) trials in patients with moderate-to-severe plaque psoriasis demonstrated superiority of deucravacitinib versus placebo and apremilast on multiple clinical endpoints, including coprimary endpoints of ≥ 75% reduction from baseline in the Psoriasis Area and Severity Index (PASI 75) and achievement of static Physician’s Global Assessment score of 0 or 1 (sPGA 0/1) [7, 8]. While objective clinical endpoints are important efficacy measures, they do not sufficiently capture a patient’s experience on treatment or the impact of treatment on their lives. PROs can better capture the burden of disease from the patient’s perspective and are an important consideration for dermatologists treating the disease to measure specific outcomes of importance to patients, including QoL and how they feel and function. Regulatory agencies recommend that PROs be evaluated using meaningful change thresholds derived from global assessments to anchor understanding of meaningful change over time [9, 10].

This analysis compared the effects of deucravacitinib versus placebo and apremilast on Psoriasis Symptoms and Signs Diary (PSSD) and the Dermatology Life Quality Index (DLQI) assessments in the POETYK PSO-1 and POETYK PSO-2 trials [8, 11].

Methods

Patients and Study Design

The study designs for POETYK PSO-1 and PSO-2 were previously described (Fig. S1) [8, 11]. In brief, both multicenter, global, randomized, double-blind, placebo- and active comparator-controlled studies evaluated the efficacy and safety of deucravacitinib versus placebo and apremilast in patients with moderate-to-severe plaque psoriasis. Eligible patients were randomized 1:2:1 to placebo, deucravacitinib 6 mg once daily, or apremilast 30 mg twice daily.

Both studies were conducted in accordance with the ethical principles of the Declaration of Helsinki and Good Clinical Practice guidelines of the International Council for Harmonisation and in accordance with the European Union Directive 2001/20/EC and the US Code of Federal Regulations, Title 21, Part 50 (21CFR50) as well as applicable local requirements. The study protocols and amendments were approved by an institutional review board or independent ethics committee before initiation of the study at each site.

In POETYK PSO-1, all patients randomized to deucravacitinib continued the same treatment regimen through Week 52. In POETYK PSO-1 and POETYK PSO-2, patients randomized to placebo crossed over in a blinded manner to deucravacitinib at Week 16.

The study protocols and amendments were approved by an institutional review board or independent ethics committee at each site. All patients or their legal representatives provided written informed consent before study participation.

Assessments

The PSSD is a measure of symptoms and signs that many patients with psoriasis may experience. It assesses the severity of five symptoms (itch, pain, stinging, burning, and skin tightness) and six signs (skin dryness, cracking, scaling, shedding or flaking, redness, and bleeding) on a numeric scale ranging from 0 (absent) to 10 (worst imaginable) [12,13,14]. Summary scores for PSSD total, symptoms, and signs assessments are derived based on average scores for the individual items, multiplied by 10 (range, 0–100). Patients completed the PSSD daily, with 24-h recall, and weekly scores were calculated as an average of daily scores for weeks with at least 4 days of PSSD completion. A range of meaningful within-patient change thresholds (MWPCTs) were derived for classification of meaningful change from baseline experienced by a given patient (improvements of ≥ 15, ≥ 25, and ≥ 30 points) that varied depending on the degree of change examined in the anchor variables (Patient Global Impression of Change and Patient Global Impression of Severity) [15]. For PSSD individual items, a 2-point change was identified as the MWPCT using these anchors [15].

The DLQI, a measure for QoL in dermatologic indications, comprises 10 items that assess the impact of a dermatologic condition on itch symptoms, self-consciousness, daily activities, clothing choices, leisure and social activities, sports and athletic activities, work and school, personal relationships, sexual difficulties, and treatment during the previous week [16]. Each DLQI item is scored on a numeric scale ranging from 0 (not at all) to 3 (very much); total scores range from 0 to 30, with total scores of 0 or 1 reflecting no impact on a patient’s life. Patients completed the DLQI at baseline, at Weeks 1, 2, and 4, and then every 4 weeks thereafter through Week 52. Four-point improvement from baseline DLQI has been reported to correspond with the minimum clinically important difference in patients with psoriasis [17, 18].

Endpoints

Results for the coprimary endpoints with deucravacitinib versus placebo were previously reported [8, 11]. Mean change from baseline in PSSD total, symptom, and sign scores, as well as mean change from baseline in DLQI scores, along with attainment of DLQI 0/1 (in those with baseline DLQI score ≥ 2), were assessed in both studies. The proportions of patients achieving meaningful within-patient change in the PSSD (defined at 3 different thresholds: ≥ 15-, ≥ 25-, and ≥ 30-point changes) and meaningful improvement in the DLQI [15, 17, 18] were evaluated. The proportion of patients achieving DLQI improvement of ≥ 5 points was also assessed [17].

The proportions of patients achieving a DLQI total score of 0 or 1 (among patients with a baseline DLQI total score of ≥ 2) were previously reported [8, 11]; change from baseline in PSSD symptom score and in the DLQI total score were assessed up to Week 52.

Statistical Analysis

The full analysis set (all randomized patients) was used for all endpoints except those relating to meaningful change analyses, which were analyzed in the PRO analysis set (defined as all patients who completed ≥ 1 PSSD item at baseline and ≥ 1 PSSD item after baseline).

Change from baseline in PSSD and DLQI scores were compared between deucravacitinib-treated patients and those who received placebo (through Week 16) or apremilast (through Week 24) using analysis of covariance models, including treatment group and the stratification factors (country: USA, Japan, China, or rest of the world; prior use of biologics: yes or no; weight: < 90 kg or ≥ 90 kg) as fixed effects, with the baseline score as a covariate. The proportion of patients who achieved a DLQI score of 0 or 1 was also evaluated.

These analyses were performed post hoc, without multiplicity adjustments. Hence, the P values provided are nominal.

For binary efficacy endpoints, data are presented as observed, with no imputation of missing data. Analyses of the continuous changes from baseline measures for patients who discontinued because of lack of efficacy or adverse events used the modified baseline observation carried forward method. Patients who discontinued study treatment at or prior to Week 16 for other reasons or who had a missing Week 16 value had the last valid observation carried forward (including the baseline value, as applicable). Patients with a missing baseline value were excluded from the analysis for the change from baseline endpoint.

Results

Patients

The PRO analysis set comprised 617 patients (placebo: n = 151; deucravacitinib: n = 306; apremilast: n = 160) in POETYK PSO-1 and 927 patients (placebo: n = 233; deucravacitinib: n = 462; apremilast: n = 232) in POETYK PSO-2.

Patient demographics were balanced across treatment groups [8, 11]. Mean disease duration ranged from 17.9 to 19.9 years, mean PASI scores ranged from 20.7 to 21.8, and 38.0% to 39.3% of patients had received prior biologic treatment. The PROs at baseline were largely similar across treatment groups (Table S1).

PROs up to Week 24

Change from Baseline in PSSD Outcomes

In the POETYK PSO-1 and PSO-2 studies, respectively, at Week 16, patients treated with deucravacitinib achieved significantly greater mean changes from baseline in PSSD total score versus placebo and apremilast (placebo: − 4.4 [95% CI − 8.5, − 0.3] and − 5.9 [95% CI − 8.6, − 3.2]; deucravacitinib: − 27.8 [95% CI − 31.2, − 24.3] and − 30.1 [95% CI − 32.1, − 28.1]; apremilast: − 18.9 [95% CI − 23.1, − 14.8] and − 22.5 [95% CI − 25.2, − 19.7]; all P < 0.0001) and versus apremilast at Week 24 (deucravacitinib: − 32.8 [95% CI: − 36.7, − 28.9] and − 30.7 [95% CI − 32.9, − 28.6]; apremilast: − 21.6 [95% CI − 26.2, − 17.0] and − 22.8 [95% CI − 25.7, − 19.9]; all p < 0.0001) (Fig. 1). A significant difference between the deucravacitinib and placebo groups in PSSD total score was observed as early as Week 1 in POETYK PSO-2 (deucravacitinib: − 4.0 [95% CI: − 4.7, − 3.3], placebo: − 2.2 [95% CI: − 3.2, − 1.3], p = 0.002) and by Week 2 in POETYK PSO-1 (deucravacitinib: − 8.7 [95% CI − 10.7, − 6.6], placebo: − 3.7 [95% CI − 6.2, − 1.3], p < 0.0001).

Fig. 1
figure 1

Mean change from baseline PSSD total score in (a) POETYK PSO-1a and (b) POETYK PSO-2.b Modified baseline observation carried forward was used to impute missing data. Error bars represent 95% confidence intervals. aPOETYK PSO-1: placebo, n = 166; deucravacitinib, n = 332; apremilast, n = 168. bPOETYK PSO-2: placebo, n = 255; deucravacitinib, n = 511; apremilast, n = 254. *P < 0.0001 vs placebo. †P < 0.0001 vs apremilast. PSSD psoriasis symptoms and signs diary

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Similarly, mean changes from baseline in PSSD symptom scores were significantly greater for patients treated with deucravacitinib versus placebo at Week 16 and versus apremilast at Weeks 16 and 24 (all p < 0.0001) (Fig. S2). Improvement from baseline in PSSD symptom score with deucravacitinib versus placebo was observed as early as Week 1 in POETYK PSO-2 (deucravacitinib: − 4.0 [95% CI − 4.7, − 3.3], placebo: − 2.2 [95% CI − 3.2, − 1.3], p = 0.006) and Week 2 in POETYK PSO-1 (deucravacitinib: − 8.3 [95% CI − 10.5, − 6.1], placebo: − 3.6 [95% CI − 6.3, − 1.0], p = 0.0002). Patients treated with deucravacitinib achieved significantly greater mean changes from baseline in all individual items in PSSD symptom score versus placebo and apremilast at Week 16 and versus apremilast at Week 24 (Fig. 2). The greatest improvement in PSSD symptoms with deucravacitinib was seen for itch.

Fig. 2
figure 2

Mean change from baseline in PSSD items at Weeks 16 and 24. (a) PSSD individual symptom and sign domain scores at baseline and mean change from baseline at Weeks 16 and 24 in POETYK PSO-1.a (b) PSSD individual symptom and sign domain scores at baseline and mean change from baseline at Weeks 16 and 24 in POETYK PSO-2.b Modified baseline observation carried forward was used to impute missing data. Error bars represent 95% confidence intervals. aPOETYK PSO-1: placebo, n = 166; deucravacitinib, n = 332; apremilast, n = 168. bPOETYK PSO-2: placebo, n = 255; deucravacitinib, n = 511; apremilast, n = 254. *P < 0.0001 vs placebo. †P < 0.01 vs apremilast. PSSD psoriasis symptoms and signs diary

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Patients in the deucravacitinib group also achieved significantly greater mean change from baseline in the PSSD sign score versus the placebo group at Week 16 and versus the apremilast group at Weeks 16 and 24 (Fig. S3). Improvements with deucravacitinib versus placebo were seen as early as Week 1 in POETYK PSO-1 (deucravacitinib: − 3.3 [95% CI − 4.6, − 1.9], placebo: − 1.7 [95% CI − 3.3, − 0.1], p = 0.048) and POETYK PSO-2 (deucravacitinib: − 3.9 [95% CI − 4.6, − 3.2], placebo: − 2.2 [95% CI − 3.2, − 1.3], p = 0.002).

Change from Baseline in DLQI Total Score

In POETYK PSO-1 and PSO-2, patients treated with deucravacitinib achieved greater mean changes from baseline in DLQI total score compared with placebo and apremilast at Week 16 (placebo: − 3.3 [95% CI − 4.3, − 2.3] and − 3.0 [95% CI − 3.7, − 2.4]; deucravacitinib: − 8.5 [95% CI − 9.3, − 7.6] and − 7.6 [95% CI − 8.1, − 7.1]; apremilast: − 5.9 [95% CI − 6.9, − 4.9] and − 5.8 [95% CI − 6.5, − 5.2]) and versus apremilast at Week 24 (deucravacitinib: − 8.6 [95% CI − 9.4, − 7.7] and − 7.5 [95% CI − 8.0, − 7.0]; apremilast: − 5.6 [95% CI − 6.7, − 4.6] and − 5.5 [95% CI − 6.1, − 4.8]; all p < 0.0001) (Fig. 3). Improvements with deucravacitinib versus placebo groups in DLQI total score were observed as early as Week 1 in both POETYK PSO-1 (deucravacitinib: − 3.4 [95% CI − 4.0, − 2.7], placebo: − 2.1 [95% CI − 2.9, − 1.3], p = 0.0006) and POETYK PSO-2 (deucravacitinib: − 3.1 [95% CI − 3.5, − 2.7], placebo: − 2.4 [95% CI − 2.9, − 1.9], p = 0.025).

Fig. 3
figure 3

Mean change from baseline in DLQI total score in (a) POETYK PSO-1a and (b) POETYK PSO-2.b Modified baseline observation carried forward was used to impute missing data. Error bars represent 95% confidence intervals. aPOETYK PSO-1: placebo, n = 166; deucravacitinib, n = 332; apremilast, n = 168. bPOETYK PSO-2: placebo, n = 255; deucravacitinib, n = 511; apremilast, n = 254. *P < 0.0001 vs placebo. †P < 0.0001 vs apremilast. DLQI dermatology life quality index

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Proportions of Patients Achieving Meaningful Improvement in PSSD

The proportions of patients with meaningful improvements from baseline of ≥ 15, ≥ 25, or ≥ 30 points on the PSSD total score were greater in the deucravacitinib group versus the placebo group at Week 16 and versus apremilast at Weeks 16 and 24 (Fig. 4). Patients treated with deucravacitinib experienced meaningful improvement in PSSD scores as early as Week 2 versus placebo (data not shown).

Fig. 4
figure 4

Percentage of patients achieving meaningful within-patient change in PSSD total score of ≥ 15 points, ≥ 25 points, and ≥ 30 points, and percentage of patients achieving improvement of ≥ 4 points and ≥ 5 points on the DLQI total score in (a) POETYK PSO-1a,b and (b) POETYK PSO-2.c,d Data are presented as observed; no imputation of missing data; no inclusion/exclusion criteria based on baseline score applied, as the values are the percentage improved from a table that presented percentage improved, stable, and worsened. aPOETYK PSO-1 (PSSD): Week 16: placebo, n = 120; deucravacitinib, n = 247; apremilast, n = 121. Week 24: deucravacitinib, n = 242; apremilast n = 117. bPOETYK PSO-1 (DLQI): Week 16: placebo, n = 143; deucravacitinib, n = 308; apremilast, n = 141. Week 24: deucravacitinib, n = 298; apremilast, n = 137. cPOETYK PSO-2 (PSSD): Week 16: placebo, n = 178; deucravacitinib, n = 378; apremilast, n = 185. Week 24: deucravacitinib, n = 360; apremilast, n = 169. dPOETYK PSO-2 (DLQI): Week 16: placebo, n = 214; deucravacitinib, n = 449; apremilast, n = 218. Week 24: deucravacitinib, n = 428; apremilast, n = 206. DLQI Dermatology Life Quality Index, MWPCT meaningful within-patient change threshold, PSSD Psoriasis Signs and Symptoms Diary

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The proportions of patients who improved from baseline ≥ 15, ≥ 25, or ≥ 30 points on the PSSD symptom score and the PSSD sign score at Week 16 were greater with deucravacitinib compared with placebo at Week 16 and versus apremilast at Weeks 16 and 24 (Table S2).

On the individual PSSD items, the proportions of patients with improvement of ≥ 2 points (considered to be clinically meaningful [17, 18]), ≥ 3 points, and ≥ 4 points in the deucravacitinib group were generally higher for itch compared with other items (Tables S3, S4, and S5). For each individual PSSD item, at each threshold, and across both trials, numerically greater proportions of patients receiving deucravacitinib reported meaningful improvement at Week 16 versus patients receiving placebo or apremilast and at Week 24 versus patients receiving apremilast.

Proportions of Patients Achieving Meaningful Improvement in DLQI

Higher proportions of deucravacitinib-treated patients improved at least 4 points on the DLQI total score compared with placebo and apremilast at Week 16 (POETYK PSO-1 and PSO-2: placebo, 43.4% and 44.9%; deucravacitinib, 77.6% and 78.6%; apremilast, 68.8% and 69.3%, respectively) and compared with apremilast at Week 24 (POETYK PSO-1 and PSO-2: deucravacitinib, 79.5% and 79.2; apremilast, 67.9% and 67.5%, respectively) (Fig. 4). Improvement of at least 5 points on the DLQI total score was greater in the deucravacitinib group compared with the placebo group at Week 16 and compared with the apremilast group at Weeks 16 and 24 (Fig. 4).

PRO Responses Through Week 52

In POETYK PSO-1 and PSO-2, improvements in PSSD total score from Weeks 16–52 were maintained with continuous treatment with deucravacitinib (Fig. 5A). Change from baseline to Week 52 in placebo crossovers at Week 16 was comparable to that seen with continuous treatment with deucravacitinib from Day 1 in POETYK PSO-1 (− 32.4) (Fig. 5A). Similar responses were seen in placebo crossovers in POETYK PSO-2 (Fig. 5B).

Fig. 5
figure 5

Outcomes through Week 52 in POETYK PSO-1a and PSO-2.b (a) Change from baseline in PSSD total score in POETYK PSO-1. (b) Change from baseline in PSSD total score in POETYK PSO-2. (c) Change from baseline in DLQI total score in POETYK PSO-1. (d) Change from baseline in DLQI total score in POETYK PSO-2. (e) Percentage of patients achieving DLQI total score of 0 or 1 in POETYK PSO-1. (f) Percentage of patients achieving DLQI total score of 0 or 1 in POETYK PSO-2. Patients who discontinued during the placebo phase were excluded from the analyses. For change from baseline in PSSD symptom and DLQI total scores, figures show analysis using modified baseline observation carried forward to impute missing data. For DLQI 0/1 response, nonresponder imputation was used to handle missing data. aPlacebo, n = 166; deucravacitinib, n = 332; placebo to deucravacitinib crossovers, n = 141. bPlacebo, n = 255; deucravacitinib, n = 511; placebo to deucravacitinib crossovers, n = 255. DLQI Dermatology Life Quality Index, PSSD Psoriasis Signs and Symptoms Diary

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Change from baseline in total DLQI score from Weeks 16–52 was also maintained with continuous deucravacitinib treatment (Fig. 5C). Change from baseline in total DLQI score at Week 52 in placebo crossovers at Week 16 was comparable to that seen with continuous treatment with deucravacitinib from Day 1 (Fig. 5C). Similar responses were seen in placebo crossovers in POETYK PSO-2 (Fig. 5D).

In POETYK PSO-1, the proportion of patients achieving a DLQI total score of 0 or 1 was maintained from 41.0% at Week 16 to 43.2% at Week 52 with continued deucravacitinib treatment (Fig. 5E). Among patients who crossed over from placebo to deucravacitinib at Week 16, achievement of DLQI total score of 0 or 1 increased over time up to Week 52 (46.1%) and was comparable to that seen in patients who had received continuous treatment with deucravacitinib from Day 1 (Fig. 5E). In POETYK PSO-2, 37.6% of patients treated with deucravacitinib achieved a DLQI total score of 0 or 1 at Week 16 (Fig. 5F). Among placebo crossovers at Week 16, achievement of DLQI total score of 0 or 1 increased over time up to Week 52 (Fig. 5F).

Discussion

PROs provide measures reported by patients that are of importance to them, which further helps clinicians in evaluating the efficacy of psoriasis therapies in improving the experiences of treated patients. Patients with moderate-to-severe psoriasis experience a high symptom burden and substantially impaired QoL [2,3,4], as measured using the PSSD and DLQI, respectively [12, 14, 16], which was observed at baseline in the POETYK PSO-1 and PSO-2 studies. This is consistent with findings from large patient surveys that demonstrated substantial burden associated with bothersome symptoms, such as itch, scaling, and flaking [19, 20].

In this analysis, treatment with deucravacitinib demonstrated improvements in two PROs versus placebo and apremilast in POETYK PSO-1 and PSO-2. There was rapid improvement in the PSSD and DLQI with deucravacitinib, with differentiation from placebo observed within the first 2 weeks. Responder analyses by MWPCT for both PSSD and DLQI assessments showed that deucravacitinib-treated patients were more likely to achieve meaningful improvement thresholds than patients receiving placebo or apremilast. These findings are consistent with previously reported results from POETYK PSO-1 and PSO-2 showing greater achievement of complete response in patients treated with deucravacitinib versus placebo or apremilast [8, 11]. The current analysis also showed that achievement of a DLQI total score of 0 or 1 was maintained through 52 weeks with continuous deucravacitinib treatment (POETYK PSO-1). Furthermore, patients who crossed over from placebo to deucravacitinib achieved rapid improvement in psoriasis symptoms and signs and QoL, with improvements from baseline at Week 52 approaching those seen with deucravacitinib treatment from Day 1.

The current analysis demonstrated that the improvements in clinician-reported outcome measures, such as PASI 75 and sPGA 0/1, were accompanied by significant improvements in psoriasis symptoms and signs and health-related QoL [8, 11].

This analysis adds to results from previous studies [21, 22] of patient-reported symptoms and signs and health-related QoL, as it describes clinically meaningful change in PROs using thresholds that account for within-patient (individual) changes reported using anchor measures during the study. The meaningful change threshold assessments were based on patient-rated global assessments of psoriasis improvement, in alignment with recommendations from regulatory guidelines [9, 10]. In a recent analysis of data from the POETYK PSO-1 and PSO-2 studies, a 25-point improvement in the PSSD total score derived from the POETYK PSO-1 pooled treatment arms was found to correspond with meaningful within-patient improvement in symptom burden for patients with moderate-to-severe psoriasis [15]. In the current analysis, deucravacitinib treatment resulted in greater improvement of ≥ 15, ≥ 25, or ≥ 30 points in PSSD total, symptom, and sign scores compared with patients treated with placebo or apremilast. This analysis also found that differentiation in PSSD total score between the deucravacitinib and placebo or apremilast arms (i.e., the ratio of change scores for placebo or apremilast versus deucravacitinib) was greater as the meaningful change threshold response increased from ≥ 15 points to ≥ 25 points and to ≥ 30 points. Itch, in particular, is a symptom closely associated with QoL impairment [23]; in this study, numerically greater proportions of patients receiving deucravacitinib versus placebo or apremilast reported meaningful improvement on the PSSD itch item, with meaningful change defined by ≥ 2-, ≥ 3-, and ≥ 4-point thresholds. In addition, improvement of ≥ 4 points on the DLQI total score was greater in the deucravacitinib group compared with the placebo and apremilast groups in both studies, and these findings were replicated when using a 5-point DLQI total score threshold. These results are consistent with the range of minimum clinically important differences reported for DLQI in psoriasis (2–6 points) [17, 18]. Together, these findings indicate that the improvements in symptom burden and health-related QoL observed with deucravacitinib treatment are clinically meaningful and have the potential to help patients with moderate-to-severe psoriasis experience improvements that are important in their daily lives.

Several limitations of this analysis should be noted. Racial diversity was limited; more than 77% of patients in POETYK PSO-1 and more than 90% in POETYK PSO-2 self-reported as being White, although this is, on average, reflective of the US population. Not all patients completed the diaries at each time point, and changes from baseline in PRO measures were not estimable for all patients at all time points. Analyses of change from baseline in PROs were not adjusted for multiplicity with nominal P values, which limits the statistical confidence in the findings. Longer-term PRO data will be assessed in the ongoing POETYK long-term extension trial (NCT04036435) of patients completing the POETYK PSO-1 and PSO-2 trials.

Conclusions

Deucravacitinib demonstrated rapid, durable, significant, and clinically meaningful improvements in psoriasis symptoms and signs and health-related QoL as reported by patients with moderate-to-severe plaque psoriasis. Together with the efficacy and safety data from the POETYK PSO-1 and PSO-2 trials reported earlier, these findings further support the benefits of deucravacitinib in psoriasis.