AB0560 EFFECT OF DEUCRAVACITINIB ON THE PSORIATIC ARTHRITIS IMPACT OF DISEASE (PsAID) QUESTIONNAIRES 12 AND 9: ANALYSIS OF A PHASE 2 STUDY OF ACTIVE PSORIATIC ARTHRITIS

Abstract

Background:Tyrosine kinase 2 (TYK2) is an intracellular kinase that mediates IL-23, IL-12, and IFNα/β signaling. Deucravacitinib is a novel, oral selective inhibitor of TYK2 via the TYK2 regulatory domain. Phase 2 results showed deucravacitinib was efficacious and well tolerated versus placebo (PBO) in patients (pts) with active psoriatic arthritis (PsA). The Psoriatic Arthritis Impact of Disease (PsAID) questionnaire is a EULAR-developed, validated instrument designed to specifically assess the impact of PsA on health-related quality of life (HRQoL) from the pt’s perspective and is available as separate versions for clinical practice (PsAID-12) and clinical trials (PsAID-9).1Objectives:To compare the effect of deucravacitinib vs PBO on PsAID-12 and PsAID-9 responses and to assess relationships between PsAID scores and clinical and pt-reported outcome (PRO) measures.Methods:This is an ongoing, 1-year, double-blind, Phase 2 trial (NCT03881059). Pts with active PsA were randomized 1:1:1 to deucravacitinib 6 mg or 12 mg once daily, or PBO for 16 weeks (wk). PsAID-12 and PsAID-9, other PROs, and clinical response outcomes were assessed at baseline (BL) and Wk 16. Mean changes from BL in PsAID-12 and PsAID-9 total scores at Wk 16 were determined for each treatment group as well as by response outcomes (ie, achievement of response at Wk 16 for PROs and select clinical response outcomes; Table 1). Spearman correlations between PsAID-12 and PsAID-9 scores and clinical and PRO measures were also assessed.Results:203 pts were randomized and BL characteristics were similar across groups. Adjusted mean changes from BL in PsAID-12 and PsAID-9 scores at Wk 16 were significantly greater in the deucravacitinib groups vs PBO (Figure 1). Adjusted mean changes from BL in PsAID-12 and PsAID-9 scores at Wk 16 were significantly improved with deucravacitinib vs PBO in pts who achieved response for PROs, as well as PASDAS low disease activity and PASI 75 response (Table 1). Adjusted mean changes from BL were generally similar with deucravacitinib vs PBO in nonresponders. Spearman correlation analysis revealed significant correlations at BL and Wk 16 between PsAID-12 and PsAID-9 scores and clinical and PRO measures (P<0.0001).Conclusion:With deucravacitinib vs PBO, PsAID-12 and PsAID-9 scores were significantly improved vs BL at Wk 16. PsAID detected additional improvements among pts achieving response for multiple other PROs and select clinical outcome measures.