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Abstract Number: 0232

The Impact of Deucravacitinib on Health-Related Quality of Life Measured by the Short Form Health Survey 36-Item Questionnaire: Analysis of a Phase 2 Trial in Patients with Active PsA

Vibeke Strand1, Philip Mease2, Atul Deodhar3, June Ye4, Miroslawa Nowak4, Jiyoon Choi4 and Brandon Becker4, 1Stanford University School of Medicine, Portola Valley, CA, 2Swedish Medical Center/Providence St. Joseph Health and University of Washington, Seattle, WA, 3Oregon Health & Science University, Portland, OR, 4Bristol Myers Squibb, Princeton, NJ

Meeting: ACR Convergence 2021

Keywords: Psoriatic arthritis, The Short Form Health Survey 36-item questionnaire (SF-36v2)

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Session Information

Date: Saturday, November 6, 2021

Session Title: Patient Outcomes, Preferences, & Attitudes Poster I: Impact (0225–0240)

Session Type: Poster Session A

Session Time: 8:30AM-10:30AM

Background/Purpose: Patients (pts) with PsA experience pain, loss of physical function, joint damage, and significant impairments in social and emotional well-being. The Short Form Health Survey 36-item questionnaire (SF-36v2), a generic measure of pt-reported health-related quality of life (HRQOL), includes 36 items and measures 8 domains—physical functioning (PF), role-physical (RP), bodily pain (BP), general health (GH), vitality (VT), social functioning (SF), role-emotional (RE), and mental health (MH)—that contribute to both physical component summary (PCS) and mental component summary (MCS) scores. Deucravacitinib is a novel, oral selective inhibitor of tyrosine kinase 2 (TYK2), an intracellular kinase that mediates cytokine signaling pathways implicated in the pathogenesis of PsA. In a Phase 2 trial in pts with active PsA, the primary endpoint, ACR 20 response at Week (Wk) 16, was met and deucravacitinib was well tolerated versus placebo (PBO).1 This analysis further evaluated the effect of deucravacitinib treatment on SF-36 scores.

Methods: This 1-year, randomized, double-blind, placebo-controlled, multicenter Phase 2 trial (NCT03881059) enrolled pts with a PsA diagnosis ≥6 months who fulfilled Classification Criteria for Psoriatic Arthritis at screening and had active joint disease (≥3 tender and ≥3 swollen joints), high-sensitivity CRP ≥3 mg/L, and ≥1 plaque psoriasis lesion (≥2 cm). Pts failed or were intolerant to ≥1 NSAID, conventional synthetic DMARD, and/or 1 TNF inhibitor (TNFi; ≤30%). Pts were randomized 1:1:1 to receive deucravacitinib 6 mg once daily (QD) or 12 mg QD, or PBO. Changes from baseline (BL) in SF-36 PCS and MCS scores at Wk 16 were prespecified key secondary and additional endpoints, respectively. Analyses evaluated the 8 SF-36 domain scores at Wk 16. The proportion of patients who reported improvements ≥2.5 and ≥5-points (the minimum clinically important difference [MCID]) in SF-36 summary and domain scores, respectively, were evaluated.

Results: Of 203 pts randomized, 180 (89%) completed 16 wks of treatment (deucravacitinib 6 mg QD, 63/70 [90%]; deucravacitinib 12 mg QD, 59/67 [88%]; PBO, 58/66 [88%]). Demographic and BL disease characteristics were similar across groups. Mean age was 49.8 years and median PsA duration since diagnosis was 4.5 years. BL mean SF-36 PCS and MCS scores were similar among deucravacitinib 6 mg QD, 12 mg QD, and PBO groups (PCS: 34.0, 34,5, and 33.4; MCS: 45.4, 46.9, and 47.5, respectively; Table). At Wk 16, adjusted mean changes from BL in SF-36 PCS and MCS scores were significantly improved (P< 0.05) with deucravacitinib 6 and 12 mg QD treatment vs PBO (Figure 1). Reported improvements in domain scores with both doses exceeded MCID and were significant in 5 of 8 domains with deucravacitinib 6 mg QD (PF, RP, BP, VT, and SF) and 6 of 8 domains with deucravacitinib 12 mg QD (RE in addition; Figure 2).

Conclusion: Pts with PsA receiving deucravacitinib treatment reported clinically meaningful and significant improvements in HRQOL, including fatigue and social functioning in addition to physical functioning and pain, at Wk 16.

Reference: 1. Mease PJ et al. Presented at the 2020 ACR Convergence, American College of Rheumatology; Nov 5-9, 2020.


Disclosures: V. Strand, Abbvie, 2, Amgen, 2, Genentech / Roche, 2, Janssen, 2, Novartis, 2, Pfizer, 2, Sanofi, 2, UCB, 2, Bristol-Myers Squibb, 2, Boehringer Ingelheim, 2, Celltrion, 2, Arena, 2, Gilead, 2, GlaxoSmithKline, 2, Ichnos, 2, Inmedix, 2, Kiniksa, 2, Merck, 2, Myriad Genetics, 2, Regeneron Pharmaceuticals, Inc., 2, Samsung, 2, Sandoz, 2, Setpoint, 2, Galapagos, 2, Horizon, 2, Lilly, 2, Rheos, 2, R-Pharma, 2, Scipher, 2, Sun Pharma, 2; P. Mease, AbbVie, 2, 5, 6, Amgen, 2, 5, 6, Bristol-Myers Squibb, 2, 5, Eli Lilly, 2, 5, 6, Galapagos, 2, 5, Celgene, 2, Boehringer Ingelheim, 2, Genentech, 2, 5, 6, Janssen, 2, 5, 6, Gilead Sciences, 2, 5, 6, Novartis, 2, 5, 6, Pfizer, 2, 5, 6, Sun Pharma, 2, 5, UCB Pharma, 2, 6, GSK, 2; A. Deodhar, Amgen, 2, Celgene, 2, Boehringer Ingelheim, 2, 12, Paid Instructor, AbbVie, 2, 5, Eli Lilly, 2, 5, Glaxo Smith & Kline, 2, 5, Novartis, 2, 5, Pfizer, 2, 5, 6, 12, Paid Instructor, UCB, 2, 5, Janssen, 2, 6, Bristol-Myers Squibb, 2; J. Ye, Bristol Myers Squibb, 3, 11; M. Nowak, Bristol Myers Squibb, 3, 11; J. Choi, Bristol Myers Squibb, 3, 11; B. Becker, Bristol Myers Squibb, 3, 11.

To cite this abstract in AMA style:

Strand V, Mease P, Deodhar A, Ye J, Nowak M, Choi J, Becker B. The Impact of Deucravacitinib on Health-Related Quality of Life Measured by the Short Form Health Survey 36-Item Questionnaire: Analysis of a Phase 2 Trial in Patients with Active PsA [abstract]. Arthritis Rheumatol. 2021; 73 (suppl 9). https://acrabstracts.org/abstract/the-impact-of-deucravacitinib-on-health-related-quality-of-life-measured-by-the-short-form-health-survey-36-item-questionnaire-analysis-of-a-phase-2-trial-in-patients-with-active-psa/. Accessed January 30, 2023.
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