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  1. D. Fedkov1,
  2. A. Berghofen2,
  3. C. Weiss3,
  4. C. Peine4,
  5. F. Lang4,
  6. J. Knitza5,6,7,
  7. J. Leipe8
  1. 1Bogomolets National Medical University, Department of Internal Medicine #3, Kyiv, Ukraine
  2. 2University Medical Centre Mannheim, Medical Faculty Mannheim, University of Heidelberg, Division of Rheumatology, Department of Medicine V, Mannheim, Germany
  3. 3Medical Faculty Mannheim, Heidelberg University, Theodor-Kutzer-Ufer, Department of Medical Statistics and Biomathematics, Mannheim, Germany
  4. 4Midaia GmbH, Product Development, Heidelberg, Germany
  5. 5Friedrich-Alexander-University Erlangen-Nürnberg (FAU), Universitätsklinikum Erlangen, Erlangen, Germany
  6. 6Friedrich-Alexander-University Erlangen-Nürnberg (FAU), Deutsches Zentrum für Immuntherapie (DZI), Erlangen, Germany
  7. 7Université Grenoble Alpes, AGEIS, Saint-Martin-d’Hères, France
  8. 8Medical Faculty Mannheim, Heidelberg University, Division of Rheumatology, Department of Medicine V, University Medical Centre, Mannheim, Germany


Background Self-management strategies play a central role in improving clinical outcomes in patients with inflammatory arthritis. EULAR recently highlighted the essential role of digital health to increase the self-management of patients. Evidence regarding these supporting digital tools, including mobile apps, is currently however very limited [1].

Objectives To evaluate the efficacy and safety of a mobile app (Mida Rheuma App) in patients with rheumatoid arthritis (RA) and spondyloarthritis (SpA, including psoriatic arthritis [PsA]) in a prospective study.

Methods Patients with RA, SpA/ PsA, stable on their antirheumatic therapy for ≥4 weeks, were eligible to use the Mida Rheuma App in addition to standard care treatment. The usage of the app targeted the optimization of non-medical treatment in a 4-step process: (1) collection of the information (HRQoL, disease activity, physical impairment, diet, mental health, physical activity, etc.) using standardized questionnaires via the conversational health coach Mida; (2) development of a patient profile that focuses on the patient’s disease, well-being, and behavior; (3) creation of a personalized, evidence-based disease management program based on recommendations from medical guidelines, medical standards, and state-of-the-art clinical research; (4) implementation of personalized recommendations into the patient’s daily life by providing short daily tasks that accelerate positive behavior change. Additionally, the health coach Mida supports the patient in coping with stress, sadness, depression, fatigue, and further disease-related symptoms. This is achieved by various cognitive behavioral techniques, meditation and relaxation methods.

Additionally, we assessed demographic parameters, treatment regimen, disease activity (e.g., SDAI, ASDAS), and other patient-reported outcomes (e.g., SF-36) at baseline and after 4 weeks. The study was approved by the Ethics Committee of the Medical Faculty of Mannheim, Heidelberg University.

Results Of 20 patients screened after obtaining informed consent, 19 were enrolled in the study, and 17 patients (12 RA, SpA: 1 axSpA, 4 PsA) completed the study (2 drop-outs due to unwillingness to finish the study). 7 (41.2%) patients were male, and ages ranged from 19 to 63 (40.5±12.2) years). Patients were treated as follows: 7 NSAIDs (41.2%), 2 GC (>5 mg) (11.8%), 3 HCQ (17.6%), 10 MTX (58.8%), 1 LEF (5.9%), 1 SSZ (5.9%), 1 APR (5.9%), 3 JAKi (17.6%), 1 TNFi (5.9%), 2 IL-6i (11.8%), 1 IL-17i (5.9%). No significant change in antirheumatic treatment was observed during the study. At baseline, 29.4% of the RA and PsA patients were in remission, 25.2% had low, 29.4% had moderate, and none had high disease activity according to SDAI, one axSpA patient had low disease activity (ASDAS: 2.2). At the end of the study, slightly more RA and PsA patients were in remission and had low disease activity (58.8% and 23.5%, respectively) and less had moderate activity (11.8%); the axSpA patient had inactive disease (ASDAS: 1.8).

Regarding patient-reported outcomes, statistically significant improvement was noted for the following parameters: SF-36 Total Score (relation of CI 90% and minimum clinically important difference of 2.5), increase of Physical Component Summary of SF-36 by 23.6% (p=0.024), ‘role limitations due to physical health’ by 76.9% (p=0.022), and ‘general health’ - by 17.1% (p=0.048); and evidence of potential clinical importance of their dynamics for Patient Health Questionnaire (PHQ)-9, ‘emotional well-being’ and RADAI-5. No negative changes were observed for assessed parameters. No adverse events were reported throughout the study.

Conclusion This prospective study suggests that using an app-based personalized disease management program significantly quickly improves several measures of patient-reported outcomes and disease activity in patients with RA and PsA/SpA. These findings highlight the potential of complementary digital therapy in patients with inflammatory arthritis.

References [1]Knitza J. JMIR Mhealth Uhealth. 2019 Aug 5;7(8):e14991

Disclosure of Interests Dmytro Fedkov Shareholder of: Midaia GmbH, Speakers bureau: Phizer, MSD, Consultant of: Janssen, Novartis, Andrea Berghofen: None declared, Christel Weiss: None declared, Christine Peine Shareholder of: Midaia GmbH, Felix Lang Shareholder of: Midaia GmbH, Johannes Knitza Consultant of: ABATON, Vila Health, Medac, Grant/research support from: ABATON, Jan Leipe: None declared

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