P0420 Interim analysis of real-world-data on PROs and biomarker remission collected through the Health Outcome Observatory (H2O) consortium in IBD patients
Authors: Novacek G , Fierens L , Primas C , Ferrante M , Schreiner P , Borruel N , Serra X , Dabsch S , Schilling V , Frick A , Reinisch W , Schweiger K , Galan G , Ferri M , Ritschl V , Mosor E , Long P , Winkler E , Mooslechner T , Wisniowski K , Kazemi-Shirazi L , Bäuerle M , Dejaco C , Stamm T 
Published: January 2025

Abstract

Background
The Health Outcome Observatory (H2O) project aims to standardize and facilitate the collection of patient reported outcomes (PROs) and clinical outcomes by Core Outcome Sets (COS) in patients with inflammatory bowel disease (IBD).1 The present study describes preliminary data on clinical and biomarker remission as well as quality of life.

Methods
This is a real-world interim analysis of IBD patients included in the H2O project at the Medical University of Vienna, Austria, and the Hospital Universitari Vall d’Hebron, Barcelona, Spain. The variables analyzed were part of the COS. Clinical remission was defined by PRO-2 (for Crohn’s disease (CD): number of liquid or very soft stools ≤3, abdominal pain score ≤1; for ulcerative colitis (UC): rectal bleeding score=0, stool frequency score ≤1), biomarker remission by faecal calprotectin (&lt;150g/g) and C-reactive protein (&lt;0.5mg/dl), and quality of life by PROMIS_10_Q02 (quality of life answered as very good or excellent). Co-primary endpoints were clinical and biomarker remission and a very good or excellent quality of life. A descriptive analysis was performed.

Results
532 patients were included in Austria (221 female [42%]; 298 CD, 178 UC, 6 IBDU, 50 with missing diagnosis) and 30 in Spain (14 female [47%]; 18 CD, 12 UC). 138 of 532 patients in Austria (26%) did not provide PRO data. The majority of patients were on advanced therapies (CD: 221/298; 77%; UC: 118/178; 66%). Among CD patients 175 were in PRO-2 remission in Austria (80%) and 13 in Spain (72%), the corresponding numbers of patients in UC PRO-2 remission were 86 in Austria (62%) and 11 in Spain (92%). Biomarker remission was observed in 128/240 CD patients (53%) and 84/135 UC patients (62%). Detailed results of the PRO-2 and of the biomarker values of the Austrian IBD patients are given in Table 1. Very good or excellent quality of life was reported by 97/224 (43.3%) CD patients and 69/140 (49.2%) UC patients. 77/240 CD patients (32%) and 58/135 UC patients (43%) were in clinical PRO-2 as well as biomarker remission and had a very good or excellent quality or life.

Conclusion
While a large number of IBD patients in tertiary university centers were in clinical PRO-2 remission a lower number of patients had a very good or excellent quality of life. Biomarker remission was achieved almost equally often as clinical PRO-2 remission in UC patients but less often in CD patients. About one third of the patients were in clinical PRO-2 and biomarker remission and had a very good or excellent quality of life. Despite the frequent use of advanced therapies there is a need for treatment optimizing to reach all treatment goals.

References
1.Fierens L, Carney N, Novacek G, van der Woude CJ, Siegmund B, Casellas F, Borruel N, Huberts AS, Sonnenberg E, Gerold N, Primas C, Hedin CRH, Stamm T, Julsgaard M, Fiorino G, Radice S, Zini MLL, Gross E, Sander C, Arijs I, Vakouftsi VR, Koltai T, Health Outcomes Observatory H O Patient Advisory Board For Inflammatory Bowel Diseases, Health Outcomes Observatory H2O Steering Committee, Charlafti I, Ferrante M. A Core Outcome Set for Inflammatory Bowel Diseases: Development and Recommendations for Implementation in Clinical Practice Through an International Multi-stakeholder Consensus Process. J Crohns Colitis. 2024 Oct 15;18(10):1583-1595. doi: 10.1093/ecco-jcc/jjad195. PMID: 38019894.