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.

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ACR Meeting Abstracts - 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/