Abstract
Background Exercise can improve the symptoms of axial spondyloarthritis (axSpA) and is recommended as a cornerstone of management for axSpA [1] . Wearable devices can objectively measure physical activity and device-generated data may support development of digitally measured novel endpoints that correlate with treatment response. Objectives To report device usage and adherence with wearable technology used to assess the physical activity of people with active ankylosing spondylitis (AS) and inadequate response to biologic DMARD therapy (bDMARD-IR) in the SELECT-AXIS 2 trial, as well as evaluate the association between baseline physical activity and patient-reported measures of functional ability and health. Methods Patients in the SELECT-AXIS 2 bDMARD-IR study ( NCT04169373 ), a 1:1 randomized, double-blind, phase 3 trial of upadacitinib vs placebo [2] , were required to wear a medical-grade wrist-worn actigraphy device that monitored physical activity during the 14-week, placebo-controlled portion of the study. Eligibility criteria included a diagnosis of active AS and inadequate response to bDMARDs. Wearable device adherence, defined as at least 16 hours per day usage, was evaluated through 14 weeks. Baseline physical activity measurements, including median daily steps and time spent in moderate to vigorous physical activity (MVPA), were defined as those in the first week of device usage after trial entry. Median daily steps at baseline were compared by sex and day of the week (weekend vs weekday) across the entire patient cohort using the Mann–Whitney test; differences in physical activity by age were assessed with the Kruskal–Wallis test. For inclusion in all other baseline analyses, patients were required to have at least 3 out of 7 days with sufficient device use, and average physical activity was calculated over these adherent days. Finally, the comparison between baseline physical activity and functional index (BASFI) or health status (ASAS Health Index [ASAS-HI]) was calculated using the Mann-Whitney test; previously established cutoffs were used to distinguish patients into groups with low, moderate, or high functional ability or health [3,4] . Results Of 420 total patients, physical activity data was collected from 394 participants, and 312 patients met minimal adherence criteria at baseline (first week). Through 14 weeks, adherence was demonstrated for 83.5% of study days ( Figure 1A ). At baseline, physical activity was higher in men than women and on weekdays than weekends; median daily steps were not significantly different based on age ( Figure 1B ). Baseline mean BASFI and ASAS-HI in the SELECT-AXIS 2 bDMARD-IR AS trial were 6.3 and 9.3 respectively, suggesting relatively high functional limitation. Patients with higher baseline functional impairment (BASFI score >7) did not statistically differ in median daily time spent in MVPA (p=0.366) but took an average of 1690 fewer steps per day (p=0.021) than patients with BASFI scores ≤4 who met the Patient Acceptable Symptom State (PASS) [3] ( Figure 1C ). Patients reporting “poor” health status [4] (ASAS-HI score ≥12 to 17) spent 30.0 fewer minutes in MVPA (p=0.005) and took 2186 fewer steps per day (p=0.010) than those with “good” health status [4] (ASAS-HI scores ≤5; Figure 1D ). Conclusion bDMARD-IR patients with AS in SELECT-AXIS 2 had high adherence with use of a wearable activity monitoring device over 14 weeks. Lower physical activity was generally associated with higher disability scores and poor health status at baseline. These data support the utility of wearable devices for assessing physical activity in people with AS, suggesting the possibility to use such devices to evaluate the impact of targeted therapeutics on passively collected physical activity and functional ability outcomes. References [1]Bull FC, et al. Br J Sports Med 2020;54:1451–62. [2]van der Heijde D, et al. Ann Rheum Dis 2022;81:1515–23. [3]Zochling J. Arthritis Care Res (Hoboken) 2011;63:S47–58. [4]Kiltz U, et al. Ann Rheum Dis 2018;77:1311–17. Acknowledgements AbbVie funded these studies and participated in the study design, research, analysis, data collection, interpretation of data, reviewing, and approval of the publication. All authors had access to relevant data and participated in the drafting, review, and approval of this publication. No honoraria or payments were made for authorship. Medical writing support was provided by Matthew Eckwahl, PhD, of AbbVie. Disclosure of Interests Philip J Mease Speakers bureau: AbbVie, Amgen, Lilly, Janssen, Novartis, Pfizer, and UCB, Consultant of: AbbVie, Acelyrin, Aclaris, Amgen, Boehringer Ingelheim, BMS, CorEvitas, Lilly, Galapagos, Gilead, GSK, Inmagene, Janssen, Moonlake, Novartis, Pfizer, Sun Pharma, and UCB, Grant/research support from: AbbVie, Acelyrin, Amgen, Boehringer Ingelheim, BMS, Lilly, Galapagos, Gilead, GSK, Janssen, Novartis, Pfizer, Sun Pharma, and UCB, Rebecca Grainger Speakers bureau: AbbVie, Pfizer, Cornerstones, and Janssen, Consultant of: Novartis, Dan Webster Shareholder of: AbbVie, Employee of: AbbVie, Michelle Crouthamel Shareholder of: AbbVie, Employee of: AbbVie, Jie Shen Shareholder of: AbbVie, Employee of: AbbVie, Yunzhao Xing Shareholder of: AbbVie, Employee of: AbbVie, Anna Shmagel Shareholder of: AbbVie, Employee of: AbbVie, Heather Jones Shareholder of: AbbVie, Employee of: AbbVie, Jeffrey Curtis Consultant of: AbbVie, Amgen, Bristol Myers Squibb, Janssen, CorEvitas, Lilly, Novartis, Myriad, Sanofi, Pfizer, and UCB, Grant/research support from: AbbVie, Amgen, Bristol Myers Squibb, Janssen, CorEvitas, Lilly, Novartis, Myriad, Sanofi, Pfizer, and UCB.