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P558 The SF-36® Health Survey distinguishes disease burden on functioning and well-being between patients with active vs inactive ulcerative colitis

Rubin D.T.*1, Panés J.2, Lindsay J.O.3, Vermeire S.4, Yarlas A.5, Bayliss M.5, Cappelleri J.C.6, Maher S.5, Bushmakin A.G.6, Chen L.A.7, Manuchehri A.8, Healey P.6

1The University of Chicago Medicine, Inflammatory Bowel Disease Center, Chicago, IL, United States 2Hospital Clinic de Barcelona, IDIBAPS, CIBERehd, Barcelona, Spain 3Centre for Immunobiology, Barts and The London School of Medicine and Dentistry, Queen Mary University of London, London, United Kingdom 4Department of Gastroenterology and Hepatology, University Hospitals Leuven, Leuven, Belgium 5Optum, Lincoln, RI, United States 6Pfizer Inc, Groton, CT, United States 7New York University School of Medicine, New York, NY, United States 8Pfizer Ltd, Tadworth, United Kingdom

Background

Active ulcerative colitis (UC) is characterised by symptoms of fatigue, abdominal pain and increased stool frequency, which directly affect how patients feel and function, but even inactive disease may adversely affect patients' functioning. The objective of this analysis was to characterise the impact of active or inactive UC on patient functioning by synthesising data from prior published studies that compared scores from the SF-36® Health Survey (SF-36), a generic measure of eight domains of functioning and well-being, between UC patients and general population or healthy benchmark samples.

Methods

This systematic literature review used search terms entered into electronic medical databases (eg, PubMed, EMBASE) including “ulcerative colitis”, “inflammatory bowel disease” and “SF-36”. We selected articles reporting SF-36 domain scores from both UC and benchmark samples. We extracted SF-36 scores, converted them into norm-based standardised T-scores (mean=50, SD=10), and summarised across studies. We assessed burden of disease by comparing differences in mean scores between UC and benchmark samples to clinically important difference (CID) thresholds established for each domain.

Results

We reviewed 27 articles that met criteria, and assessed burden in 14 studies of patients with active UC, and 15 studies of patients with inactive UC (either in clinical remission or post-surgery). Results are presented in Table 1. Across studies, patients with active UC exhibited clinically meaningful differences in all SF-36 domains: mean differences with benchmark samples across studies exceeded CID thresholds for all eight SF-36 domains. Findings across studies of patients with inactive UC showed little or no evidence of disease burden, with mean differences less than CID thresholds for seven of the eight SF-36 domains (all but General Health).

Conclusion

Patients with active UC experience a clinically meaningful burden of disease across all domains of physical and mental functioning and well-being that are captured by the SF-36. Patients with inactive UC are comparable to healthy controls and the general population on these outcomes. These findings support the benefit of effective treatments of UC to reduce the broad and substantial burden on patients' feeling and functioning, or even eliminate this burden, resulting in normalised functioning and well-being. Inclusion of the SF-36 in future studies of UC induction and maintenance will enable assessment of treatment impact on disease burden.