Abstract
Background
One-third of patients with acute severe ulcerative colitis (ASC) fail to respond to intravenous corticosteroids (IVCS) and require second-line therapy or colectomy. We aimed to explore the performance of the Pediatric Ulcerative Colitis Activity Index (PUCAI), for predicting response to IVCS in adults with ASC, and to base a two-step decision-making process for guiding the introduction of second-line therapy.
Methods
This was a retrospective multicenter cohort study of adult patients with ASC. PUCAI score, Oxford criteria, and Swedish index were determined at baseline, day three and five of hospitalization, and discharge when outcomes were ascertained.
Results
153 patients were included (mean age 34.7 ± 14.6, median disease duration 7.8 years [IQR 0–17.4]), of whom 51 (33%) required second-line therapy, and 23 (15%) eventually underwent colectomy by discharge. At days three and five, the median PUCAI scores were higher in non-responders compared with responders (55 [45–69] vs. 38 [25–55] at day 3, and 55 [36–65] vs. 20 [5–30] at day 5; both p < .001). The negative and positive predictive values (NPV and PPV) of IVCS failure were 76/63% for the Oxford criteria, 83/52% for the Swedish index as determined on day 3, and 73/100% for PUCAI ≥ 65 points on day five. The corresponding figures for PUCAI ≥ 45 at day 3 were 83/54%.
Conclusion
The PUCAI is a highly predictive tool for IVCS failure. PUCAI ≥ 45 on day 3 has an excellent NPV for IVCS failure indicating preparation for second-line therapy, and PUCAI ≥ 65 on day 5 has a high PPV to initiate the therapy.
Acknowledgements
This work was supported in part by the National Institute for Health Research (NIHR) Oxford Biomedical Research Centre (BRC). The views expressed are those of the author(s) and not necessarily those of the NHS, the NIHR, or the Department of Health.
Author contributions
OA: writing the manuscript, study design, and data analysis. AG: patient recruitment, data collection, and revision of the manuscript. ST: patient recruitment, data collection, and revision of the manuscript. DT: study design, patient recruitment, data collection, and revision of the manuscript. BK: patient recruitment, data collection, and revision of the manuscript.
Disclosure statement
ST – Grants/Research Support: AbbVie, Buhlmann, Celgene, IOIBD, Janssen, Lilly, Pfizer, Takeda, UCB, Vifor, and Norman Collisson Foundation. Consulting Fees: AbbVie, Allergan, Amgen, Arena, Asahi, Astellas, Biocare, Biogen, Boehringer Ingelheim, Bristol-Myers Squibb, Buhlmann, Celgene, ChemoCentryx, Cosmo, Enterome, Ferring, Giuliani SpA, GSK, Genentech, Immunocore, Immunometabolism, Indigo, Janssen, Lexicon, Lilly, Merck, MSD, Netbiotix, Neovacs, Novartis, NovoNordisk, NPS Pharmaceuticals, Pfizer, Proximagen, Receptos, Roche, Sensyne, Shire, Sigmoid Pharma, SynDermix, Takeda, Theravance, Tillotts, Topivert, UCB, VHsquared, Vifor, Zeria. Speaker fees: AbbVie, Amgen, Biogen, Ferring, Janssen, Shire, Takeda. No stocks or share options.
DT has received consultation fees, research grants, royalties, or honorarium from Janssen, Pfizer, Hospital for Sick Children, Ferring, Abbvie, Takeda, Biogen, Neopharm, Uniliver, Atlantic Health, Shire, Celgene, Lilly, Roche.
BK has received consultation fees from Takeda, Pfizer, Janssen.