Deucravacitinib in Moderate to Severe Psoriasis: Clinical and Quality-of-Life Outcomes in a Phase 2 Trial

Abstract

Introduction: Deucravacitinib is an oral, selective tyrosine kinase 2 inhibitor that demonstrated therapeutic benefit in a Phase 2 clinical trial of adults with moderate to severe plaque psoriasis. This analysis was designed to evaluate the effect of deucravacitinib on additional clinical and quality-of-life (QoL) outcomes and assess the relationship between these outcomes in adults with psoriasis.

Methods: Post-hoc analysis of a 12-week Phase 2 trial was conducted for the three most efficacious dosage groups (3 mg twice daily, 6 mg twice daily, 12 mg once daily) and placebo. Investigator assessments for efficacy included Psoriasis Area and Severity Index (PASI), body surface area (BSA) involvement, and static Physician's Global Assessment; QoL was assessed using the Dermatology Life Quality Index (DLQI). Treatment responses and their associations were evaluated over time.

Results: Deucravacitinib elicited improvement versus placebo as early as Week 4 for most efficacy measures (including changes in absolute PASI and BSA), with efficacy trends observed from Week 2 to Week 12. Improvements in QoL, assessed by achievement of a DLQI overall score of 0/1 (no effect at all on patient's life), followed a pattern similar to deucravacitinib-related clinical outcomes over 12 weeks. Overall, patients with greater improvements in psoriasis-related clinical signs and symptoms also reported greater improvement in QoL. However, complete skin clearance was not required for achieving DLQI 0/1.

Conclusion: Deucravacitinib treatment produced early response and similar trends in improvements across multiple efficacy assessments and QoL in moderate to severe plaque psoriasis. Deucravacitinib has the potential to become a promising new oral therapy for this condition.

Trial registration: ClinicalTrials.gov identifier; NCT02931838.

Keywords: Body surface area; Humans; Psoriasis; Quality of life; TYK2.

© 2022. The Author(s).

Figures

Fig. 1

Mean percentage change from baseline in PASI scores over time for placebo and the deucravacitinib 3 mg BID, 6 mg BID, and 12 mg QD dosage groups. BID twice daily; PASI Psoriasis Area and Severity Index; PBO placebo; QD once daily

Fig. 2

Mean absolute change from baseline in BSA percentage over time for placebo and the deucravacitinib 3 mg BID, 6 mg BID, and 12 mg QD dosage groups. BID twice daily; BSA body surface area; PBO placebo; QD once daily

Fig. 3

Response rates at Week 12 for a PASI 90, b PASI 100, c sPGA 0/1, d absolute PASI ≤ 5, e absolute PASI ≤ 3, f absolute PASI ≤ 1, g BSA (≤ 1% and ≤ 3%), and h sPGA × BSA 75 for placebo and the deucravacitinib 3 mg BID, 6 mg BID, and 12 mg QD dosage groups. BID twice daily; BSA, body surface area; PASI 75 at least 75% reduction from baseline in Psoriasis Area and Severity Index; PASI 90 at least 90% reduction from baseline in Psoriasis Area and Severity Index; PASI 100 100% reduction from baseline in Psoriasis Area and Severity Index; PBO placebo; QD every day; sPGA × BSA 75 at least 75% improvement from baseline in the product of the static Physician’s Global Assessment and body surface area involvement

Fig. 4

Percentage of patients with a DLQI overall score of 0/1, which reflects no impact on patient’s life, for placebo and the deucravacitinib 3 mg BID, 6 mg BID, and 12 mg QD dosage groups. BID twice daily; DLQI Dermatology Life Quality Index; QD every day; QoL quality of life

Fig. 5

Time course of PASI 75, PASI 90, sPGA 0/1, and DLQI overall score of 0/1 response rates for the combined deucravacitinib 3 mg BID, 6 mg BID, and 12 mg QD dosage groups. BID twice daily; DLQI Dermatology Life Quality Index; PASI 75 at least 75% reduction from baseline in Psoriasis Area and Severity Index; PASI 90 at least 90% reduction from baseline in Psoriasis Area and Severity Index; QD every day; sPGA static Physician’s Global Assessment

Fig. 6

DLQI 0/1 at Week 12 by absolute PASI (a), PASI response band (b), and BSA response band (c) for the combined patient groups of deucravacitinib 3 mg BID, 6 mg BID, and 12 mg QD dosage groups. BID twice daily; BSA body surface area; DLQI Dermatology Life Quality Index; PASI Psoriasis Area and Severity Index; PASI < 25 < 25% improvement from baseline Psoriasis Area and Severity Index; PASI 25 to < 50 25% to < 50% improvement; PASI 50 to < 75 50% to < 75% improvement; PASI 75 to < 90 75% to < 90% improvement; PASI 90 to < 100 90% to < 100% improvement; PASI 100 100% improvement from baseline Psoriasis Area and Severity Index; QD once daily