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.References:[1]Gossec L et al. Ann Rheum Dis. 2014;73:1012-9.Table 1.Adjusted mean change from BL in PsAID-12 total scores at Wk 16 in patients who achieved PRO or clinical responseMean change from BL in PsAID-12 total scoreResponse DefinitionPBOn=66Deucravacitinib6 mg QDn=70P valuevs PBODeucravacitinib12 mg QDn=67P valuevs PBOPROsPatient global VAS(≤ -10.0)-1.6 (n=40)-2.8 (n=54)0.0008-2.9 (n=48)0.0003Patient pain VAS(≤ -10.0)-2.3 (n=32)-3.4 (n=44)0.004-3.3 (n=45)0.004HAQ-DI(≤ -0.35)-2.8 (n=10)-3.8 (n=27)0.09-3.8 (n=27)0.11FACIT-Fatigue(≥ 4.0)-2.4 (n=27)-3.3 (n=36)0.02-3.6 (n=41)0.002SF-36 PCS(≥ 2.5)-1.7 (n=35)-2.7 (n=44)0.02-3.1 (n=43)0.001SF-36 MCS(≥ 2.5)-2.1 (n=21)-3.5 (n=33)0.005-3.8 (n=31)0.0009Clinician assessmentsPASDAS(≤ 3.2)-3.1 (n=6)-4.2 (n=14)0.004-4.5 (n=15)0.0006PASI 75(≥75% improvementfrom BL)-2.4 (n=11)-3.7 (n=25)0.05-3.9 (n=31)0.02PsAID-9 results were generally consistent with PsAID-12 (data not shown).Response definitions based on published literature.Higher FACIT-Fatigue scores indicate less fatigue.Higher SF-36 PCS and SF-36 MCS scores indicate less disability.BL, baseline: FACIT, Functional Assessment of Chronic Illness Therapy; HAQ-DI, Health Assessment Questionnaire-Disability Index; MCS, Mental Component Summary; NA, not applicable; PASDAS, Psoriatic Arthritis Disease Activity Score; PASI, Psoriasis Area and Severity Index; PCS, Physical Component Summary; PRO, patient-reported outcome; QD, once daily; SF-36, 36-item Short Form Health Survey; VAS, visual analog scale.Acknowledgements:This study was sponsored by Bristol Myers Squibb. Professional medical writing assistance was provided by Peloton Advantage, LLC, an OPEN Health company, and funded by Bristol Myers Squibb.Disclosure of Interests:Laure Gossec Consultant of: AbbVie, Amgen, Boehringer Ingelheim, Bristol-Myers Squibb, Celgene, Eli Lilly, Gilead, Janssen, Novartis, Pfizer, and UCB, Grant/research support from: Amgen, Galapagos, Janssen, Lilly, Pfizer, Sandoz, Sanofi, Laura C Coates Speakers bureau: AbbVie, Amgen, Biogen, Celgene, Gilead, Eli Lilly, Janssen, Medac, Novartis, Pfizer, and UCB, Consultant of: AbbVie, Amgen, Boehringer Ingelheim, Bristol-Myers Squibb, Celgene, Eli Lilly, Gilead, Janssen, Novartis, Pfizer, and UCB, Grant/research support from: AbbVie, Amgen, Celgene, Eli Lilly, Pfizer, and Novartis, Alexis Ogdie Consultant of: Abbvie, Amgen, BMS, Celgene, Corrona, Gilead, Janssen, Lilly, Novartis, Pfizer, UCB; Grants: Pfizer to Penn, Novartis to Penn, Amgen to Forward/NDB; Royalties: Novartis to husband, Philip J Mease Consultant of: AbbVie, Amgen, Boehringer Ingelheim, Bristol Myers Squibb, Eli Lilly, Galapagos, Gilead, GlaxoSmithKline, Janssen, Novartis, Pfizer, SUN Pharma, UCB, Grant/research support from: AbbVie, Amgen, Boehringer Ingelheim, Bristol Myers Squibb, Eli Lilly, Galapagos, Gilead, GlaxoSmithKline, Janssen, Novartis, Pfizer, SUN Pharma, UCB, Thomas Lehman Shareholder of: Bristol Myers Squibb, Employee of: Bristol Myers Squibb, Miroslawa Nowak Shareholder of: Bristol Myers Squibb, Employee of: Bristol Myers Squibb, Lan Wei Shareholder of: Bristol Myers Squibb, Employee of: Bristol Myers Squibb, June Ye Shareholder of: Bristol Myers Squibb, Employee of: Bristol Myers Squibb, Jiyoon Choi Shareholder of: Bristol Myers Squibb, Employee of: Bristol Myers Squibb, Joe Zhuo Shareholder of: Bristol Myers Squibb, Employee of: Bristol Myers Squibb, Brandon Becker Shareholder of: Bristol Myers Squibb, Employee of: Bristol Myers Squibb.