Achievement of increasingly stringent clinical disease control criteria was associated with greater improvements in physical function, pain and fatigue in patients with active psoriatic arthritis: 52-Week results from BE OPTIMAL, a phase 3 randomised, placebo-controlled study

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Kristensen, LE
Coates, LC
Mease, PJ
Merola, JF
Gisondi, P
Nash, P
Orbai, AM
Tillett, W
Ink, B
Bajracharya, R
Taieb, V
Lambert, J
Willems, D
Mottis, A
Walsh, JA
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2023
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Interlaken, Switzerland

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Introduction: Psoriatic arthritis (PsA) joint/skin manifestations place substantial burden on patient (pt) quality of life. [1] Bime-kizumab (BKZ) is a monoclonal IgG1 antibody that selectively inhibits IL-17F in addition to IL-17A.We examine associations between achieving clinical disease control criteria and patient-reported measures of physical function, pain and fatigue in pts with PsA. Methods: BE OPTIMAL (NCT03895203) comprised a 16-wk double-blind placebo (PBO)-controlled period and 36-wk treat-ment-blind period. Pts were ≥18 years, biologic disease-modi-fying antirheumatic drug naïve, with adult-onset, active PsA, ≥3 tender and ≥3 swollen joints. Pts were randomised 3:2:1, BKZ 160 mg every 4 weeks (Q4W):PBO:adalimumab 40 mg Q2W. From Wk16, PBO pts received BKZ Q4W. In this analysis, all pts who reached specified disease control criteria (ACR: <ACR20, ACR20– <ACR50, ACR50– <ACR70, ACR70; ACR50 and Psoria-sis Area and Severity Index 100 [ACR50+PASI100]: non-re-sponder/responder; Disease Activity in PsA [DAPSA]: high/moderate/low disease activity or remission [HDA, MoDA and LDA/REM]; Minimal Disease Activity [MDA]: non-MDA/MDA) at Wk52 were pooled across treatments. Associa-tions between achieving these criteria and improvements in pa-tient-reported physical function and symptom measures were assessed (Health Assessment Questionnaire Disability Index [HAQ-DI], Pt’s Assessment of Arthritis Pain Visual Analog Scale [Pain VAS], Functional Assessment of Chronic Illness Therapy-Fatigue subscale [FACIT-Fatigue]). Some aspects of the dis-ease control criteria relate to aspects of HAQ-DI and PtAAP. Data are observed case. Results: 761/852 (89.3%) pts completed Wk52. Baseline mean (SD) HAQ-DI (0[best]–3[worst]), Pain VAS (0[best]–100[worst]) and FACIT-Fatigue (0[worst]–52[best]): 0.85 (0.59), 55.2 (23.9) and 37.0 (9.7). Pts achieving higher ACR responses demonstrated greater mean (95% CI) improvements from base-line in HAQ-DI ( <ACR20: 0.0 [−0.1, 0.1]; ACR70: −0.6 [−0.7, −0.6]), Pain VAS ( <ACR20: −3.8 [−7.7, 0.1]; ACR70: −49.6 [−52.2, −46.9]) and FACIT-Fatigue ( <ACR20: 0.2 [0.0, 0.3]; ACR70: 1.0 [0.9, 1.1]). Similar improvements were seen with achievement of ACR50+PASI100, increasing DAPSA thresholds and MDA. Conclusions: Pts with PsA achieving stringent disease control criteria reported greater improvements in physical function, pain and fatigue at Wk 52.

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Swiss Medical Weekly

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Supplementum 271: Abstracts of the Annual meeting of the Swiss Society of Rheumatology

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153

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8

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Clinical sciences

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Life Sciences & Biomedicine

Medicine, General & Internal

General & Internal Medicine

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Kristensen, LE; Coates, LC; Mease, PJ; Merola, JF; Gisondi, P; Nash, P; Orbai, AM; Tillett, W; Ink, B; Bajracharya, R; Taieb, V; Lambert, J; Willems, D; Mottis, A; Walsh, JA, Achievement of increasingly stringent clinical disease control criteria was associated with greater improvements in physical function, pain and fatigue in patients with active psoriatic arthritis: 52-Week results from BE OPTIMAL, a phase 3 randomised, placebo-controlled study, Swiss Medical Weekly, 2023, 153 (8), pp. 24S-24S