Association of Clinical Response Criteria and Disease Activity Levels With Physical Function and HRQoL in Patients With Active Axial Spondyloarthritis: 16-Week Results From Two Phase 3 Randomised, Placebo-Controlled Studies
Author(s)
Magrey M1, Deodhar A2, Mease PJ3, Navarro-Compán V4, Ramiro S5, Rudwaleit M6, de la Loge C7, Fleurinck C7, Taieb V8, Mørup MF9, Oortgiesen M10, Kay J11
1Case Western Reserve University, Cleveland, OH, USA, 2Oregon Health & Science University, Portland, OR, USA, 3Swedish Medical Center/Providence St. Joseph Health and University of Washington, Seattle, WA, USA, 4La Paz University Hospital, Madrid, Spain, 5Leiden University Medical Center, Leiden, Netherlands, 6Bielefeld University, Bielefeld, Germany, 7UCB Pharma, Brussels, Belgium, 8UCB Pharma, Colombes, France, 9UCB Pharma, Copenhagen, Denmark, 10UCB Pharma, Raleigh, NC, USA, 11UMass Chan Medical School and UMass Memorial Medical Center, Worcester, MA, USA
OBJECTIVES: To examine the association of clinical response criteria and disease activity levels with changes in physical function and health-related quality of life (HRQoL) in patients with axial spondyloarthritis (axSpA).
METHODS: This post hoc analysis reports results from the phase 3 studies, BE MOBILE-1 (NCT03928704; non-radiographic axSpA [nr-axSpA]) and BE MOBILE-2 (NCT03928743; ankylosing spondylitis [AS]). All patients reaching specified clinical response criteria (ASAS: 20% improvement from baseline not reached [<ASAS20], 20% reached but 40% not reached [ASAS20–<ASAS40], 40% reached [ASAS40]; ASAS partial remission [ASAS-PR]: Yes, No) or disease activity levels (ASDAS: >3.5, ≥2.1–≤3.5, ≥1.3–<2.1, <1.3) at Week (Wk)16 were pooled regardless of treatment (placebo/bimekizumab 160mg Q4W), by study. Associations between achievement of these criteria/disease activity levels and improvements in physical function (BASFI) and HRQoL (ASQoL, EQ-5D-3L utilities [UK tariff], SF-36 PCS) were assessed; components of these criteria relate to BASFI. Observed case data reported.
RESULTS: The majority of patients completed Wk16 (nr-axSpA: 244/254 [96.1%]; AS: 322/332 [97.0%]). Baseline BASFI, ASQoL, EQ-5D-3L and SF-36 PCS scores were comparable across studies. Patients achieving higher ASAS response levels demonstrated sequentially greater mean (95% CI) improvements from baseline in BASFI score (nr-axSpA: <ASAS20: −0.01 [−0.25, 0.23], ASAS20–<ASAS40: −1.78 [−2.16, −1.39], ASAS40: −4.00 [−4.41, −3.58]; AS: −0.46 [−0.71, −0.21], −1.35 [−1.65, −1.06], −3.50 [−3.82, −3.18]). Achievement of higher ASAS response levels was associated with improvements in EQ-5D-3L score (nr-axSpA: <ASAS20: 0.08 [0.02, 0.14], ASAS20–<ASAS40: 0.21 [0.14, 0.29], ASAS40: 0.26 [0.20, 0.32]; AS: 0.08 [0.03, 0.14], 0.16 [0.10, 0.22], 0.31 [0.26, 0.35]); similar improvements were seen for both ASQoL and SF-36 PCS when correlated with ASAS-PR and ASDAS (data not shown).
CONCLUSIONS: Patients with nr-axSpA and AS achieving increasingly stringent clinical response criteria and lower disease activity levels at Wk16 reported greater improvements in physical function and HRQoL.
Conference/Value in Health Info
Value in Health, Volume 25, Issue 12S (December 2022)
Code
PCR196
Topic
Patient-Centered Research
Topic Subcategory
Patient-reported Outcomes & Quality of Life Outcomes
Disease
No Additional Disease & Conditions/Specialized Treatment Areas