The novel digital therapeutic Axia improves disease activity, functionality, and quality of life in axial spondyloarthritis patients: a randomized controlled trial

Despite increasing digitalization and the central role of non-pharmacological interventions in rheumatic diseases, no digital therapeutic (DTx) has yet been shown to meaningfully improve disease activity in rheumatology. Axia is a novel app-based DTx for axial spondyloarthritis (axSpA) that combines personalized exercise therapy, patient education, and disease management, supported by gamification elements to enhance long-term adherence. To evaluate its clinical efficacy, we conducted a 12-week nationwide, randomized, controlled interventional trial (RCT) involving 200 axSpA patients with stable pharmacotherapy. Patients were randomized (1:1) to either using Axia (intervention group) or standard of care (control group). Of the 200 axSpA patients enrolled, 186 participants (95 in the intervention group and 91 in the control group) completed the study. Compared to control, participants in the Axia intervention group demonstrated significant improvements in disease activity (Bath Ankylosing Spondylitis Disease Activity Index [BASDAI]; ANCOVA-estimated group difference: -1.508, p<0.001), functional status (Bath Ankylosing Spondylitis Functional Index [BASFI]; -1.139; p<0.001) and disease-specific quality of life (Ankylosing Spondylitis Quality of Life questionnaire [ASQoL]; -2.297; p<0.001), all exceeding minimal clinically important difference (MCID) thresholds. Furthermore, a significantly higher proportion of patients in the intervention group achieved an Assessment of Spondyloarthritis International Society (ASAS)20 response compared to the control group (51% vs. 9%; p<0.001), and the ASAS40 response rate was also markedly higher (23% vs. 3%; p<0.001). No concerning safety signals were observed. These findings mark the first large-scale RCT to demonstrate that a digital intervention can improve disease activity in inflammatory rheumatic disease, supporting its potential as a scalable, non-pharmacological care model. DRKS-ID: DRKS00033783