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Patient-Reported Outcome and Clinical Scores Are Equally Accurate in Predicting Mucosal Healing in Ulcerative Colitis: A Prospective Study

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Abstract

Background

Optimal management of patients with ulcerative colitis (UC) requires the accurate, objective assessment of disease activity.

Aims

We aimed to determine how strong patient-reported outcomes, clinical scores and symptoms correlate with endoscopy and biomarkers for assessment of disease activity in patients with UC.

Methods

Consecutive patients with UC followed at the McGill University IBD Center and referred for endoscopy (surveillance or flare) were included prospectively between September 2018 and August 2020. Patient-reported outcome (PRO2), partial Mayo, Simple Clinical Colitis Activity Index (SCCAI), Mayo endoscopic subscore (MES) and Baron and Ulcerative Colitis Endoscopic Index of Severity (UCEIS) scores were calculated. C-reactive protein (CRP) and fecal calprotectin (FCAL) were collected.

Results

A total of 171 patients with UC [age: 49(IQR:38–61) years, female: 46.2%, 57.3% extensive disease, 42.7% on biologicals] were included prospectively. Rectal bleeding (RBS), stool frequency (SF) subscore of 0, or total PRO2 remission (RBS0 and SF ≤ 1), partial Mayo (≤ 2) and SCCAI (≤ 2.5) remission were similarly associated with mucosal healing defined by MES (0 or ≤ 1), Baron (0 or ≤ 1) or UCEIS (≤ 3) scores in ROC analysis (AUC:0.93–0.72). There was a moderate-to-strong agreement between MES Baron and UCEIS (K = 0.91–0.41). A UCEIS of ≤ 3 was identified as the best cutoff to clinical or endoscopic remission. Agreement between CRP and clinical remission or endoscopic healing (MES/Baron) was poor (K ~ 0.2), while agreement between FCAL and RBS-PRO2 or MES/Baron/UCEIS was moderate to strong (K = 0.44–0.70).

Conclusions

Agreement between RBS, SF, PRO2, partial Mayo and SCCAI in predicting endoscopic healing was moderate to strong, while no clinically meaningful difference was found in accuracy across the scores and definitions. FCAL, but not CRP, was associated to clinical and endoscopic remission.

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Acknowledgments

The article was presented with preliminary data at the ECCO and UEG week 2020 and with final results at DDW 2021 and ECCO 2021.

Funding

The study was supported by the McGill CAS Research Support Program and the WI244988 Pfizer unrestricted research grant.

Author information

Author notes

  1. Petra Anna Golovics and Lorant Gonczi have contributed equally to this work.

Authors and Affiliations

  1. Division of Gastroenterology, Medical Centre, Hungarian Defence Forces, Podmaniczky u 109-111, Budapest, 1062, Hungary

    Petra Anna Golovics

  2. 1st Department of Medicine, Semmelweis University, Koranyi S u 2/a, Budapest, 1083, Hungary

    Lorant Gonczi & Peter L. Lakatos

  3. Division of Gastroenterology, McGill University Health Centre, Montreal General Hospital, 1650 Ave. Cedar, D16.173.1, Montreal, QC, H3G 1A4, Canada

    Jason Reinglas, Christine Verdon, Sheetal Pundir, Waqqas Afif, Gary Wild, Alain Bitton, Talat Bessissow & Peter L. Lakatos

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  1. Petra Anna Golovics
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  2. Lorant Gonczi
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Corresponding author

Correspondence to Peter L. Lakatos.

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Conflict of interest

None declared by all co-authors.

Ethical considerations

The study was approved by the McGill University Health Centre institutional reviews board and ethics committee (REB no. 2019–4842). The research protocol conforms to ethical guidelines of the 1975 Declaration of Helsinki (6th revision, 2008) and local regulations. Informed consent was obtained from each patient included in the study.

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Golovics, P.A., Gonczi, L., Reinglas, J. et al. Patient-Reported Outcome and Clinical Scores Are Equally Accurate in Predicting Mucosal Healing in Ulcerative Colitis: A Prospective Study. Dig Dis Sci 67, 3089–3095 (2022). https://doi.org/10.1007/s10620-021-07178-w

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  • DOI: https://doi.org/10.1007/s10620-021-07178-w

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