Lba0004 Remote Monitoring and Patient-Initiated Care Compared to Regular Face-to-Face Outpatient Visits in Axial Spondyloarthritis: Results From a Randomized Non-Inferiority Trial

Background: Novel follow-up strategies such as Remote Monitoring and Patient-initiated Care may allow for more targeted and efficient use of health-care resources compared to conventional prescheduled face-to-face outpatient visits. However, knowledge regarding the effectiveness of these strategies is scarce. This is the first randomized clinical trial assessing novel follow-up strategies, Remote Monitoring and Patient-initiated Care, versus Usual Care, in axial spondyloarthritis (axSpA). Objectives: To determine whether (i) Remote Monitoring or (ii) Patient-initiated Care for axSpA were non-inferior to (iii) Usual Care in maintaining low disease activity (Ankylosing Spondylitis Disease Activity Score (ASDAS) <2.1) over 18 months. Methods: ReMonit is a three-armed, single-center, parallel-group, randomized, controlled, open-label non-inferiority trial assessing patients with axSpA in low disease activity on stable treatment with a tumor necrosis factor inhibitor (TNFi). Patients were randomized 1:1:1 to Usual Care with face-to-face hospital visits every six months, Remote Monitoring with monthly digital reporting of patient-reported outcomes (PROs) and no prescheduled visits, or Patient-initiated Care with self-monitoring and no prescheduled visits during the 18-months follow-up. In Remote Monitoring, patients were contacted if the PROs exceeded a pre-defined value (Bath Ankylosing Disease Activity Index ≥4), and were offered a consultation. Patients in all groups could contact the study nurse and request a consultation. The primary endpoint was low disease activity (ASDAS <2.1) evaluated at three timepoints, at 6, 12, as well as 18 months for each patient. Secondary outcomes included other measures of disease activity (ASDAS continuous, C-reactive protein), physical function (Bath Ankylosing Spondylitis Functional Index), patient satisfaction with care, and number of consultations and telephone calls with a rheumatologist or a rheumatology nurse. Mixed effect logistic regression was used to estimate the group-specific marginal probability of ASDAS <2.1 across 6, 12 and 18 months. The non-inferiority of Remote Monitoring vs. Usual Care, and Patient-initiated Care vs. Usual Care was assessed for the between-group differences in the probability of ASDAS <2.1, using a family-wise error rate of 2.5% and a non-inferiority (NI) margin of 15%. If Patient-initiated Care was shown to be non-inferior to Usual Care, it was predefined to assess non-inferiority of Patient-initiated Care vs. Remote Monitoring [1]. ClinicalTrials.gov no. NCT06211322. Results: Of 346 screened patients, 242 were enrolled between September 2021 and June 2022 and randomly allocated to the 3 study arms (Usual Care: n=82, Remote Monitoring: n=79, Patient-initiated Care: n=81). The mean age was 44 years (SD 12), 182 (75%) were males, and mean ASDAS was 1.0 (SD 0.5) at baseline, with balanced study groups. No significant between group differences in ASDAS<2.1 were seen, and upper boundary of 95% CI was well below NI-margin (Figure 1). Both Remote Monitoring and Patient-initiated Care were deemed non-inferior to Usual Care, and Patient-initiated Care to Remote Monitoring. Secondary endpoints on disease activity and function were comparable (Figure 2). Patient satisfaction with care was similar across the three study arms at all timepoints with >90% reporting to be satisfied or very satisfied with the follow-up. The number of consultations were higher in Usual Care than in Remote Monitoring and Patient-initiated Care, but number of telephone calls was higher in Remote Monitoring than Usual Care and Patient Initiated Care (Figure 2). Conclusion: In this study, Remote Monitoring and Patient-initiated Care were both non-inferior to Usual Care in maintaining low disease activity in axial spondyloarthritis over an 18-month period. Patient-initiated Care was also non-inferior to Remote Monitoring. The results indicate that such follow-up strategies could be implemented in patients with axSpA in low disease activity, as an alternative to regular outpatient visits to optimize health care recourses. REFERENCES: [1] Berg et al. JMIR Res Protoc. 2023 Dec 27;12:e52872. Acknowledgements: NIL. Disclosure of Interests: Inger Jorid Berg Has received fees from Novartis in 2019 outside the submitted work, Joseph Sexton: None declared, Eirik Kristianslund: None declared, Anne Therese Tveter: None declared, Gunnstein Bakland From UCB, outside the submitted work, Laure Gossec grants or personal fees from AbbVie, Amgen, Biogen, BMS, Celltrion, Galapagos, Janssen, Lilly, MSD, Novartis, Pfizer, Sandoz, Stada and UCB outside the submitted work, Espen A Haavardsholm speaker or consultant fees from Pfizer, AbbVie, UCB Pharma, Eli Lilly, Novartis, and Boehringer Ingelheim outside the submitted work, speaker or consultant fees from Pfizer, AbbVie, UCB Pharma, Eli Lilly, Novartis, and Boehringer Ingelheim outside the submitted work, Sarah Hakim: None declared, Gary J. Macfarlane: None declared, Ellen Moholt: None declared, Sella Aarrestad Provan speaker or consultant fees from Pfizer and Boehringer Ingelheim outside the submitted work, research grant from Boehringer Ingelheim outside the submitted work, Emil Eirik Kvernberg Thomassen: None declared, Annette de Thurah: None declared, Siri Lillegraven: None declared, Nina Osteras: None declared.