Infliximab versus ciclosporin for steroid-resistant acute severe ulcerative colitis (CONSTRUCT): a mixed methods, open-label, pragmatic randomised trial

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Presentation transcript:

Infliximab versus ciclosporin for steroid-resistant acute severe ulcerative colitis (CONSTRUCT): a mixed methods, open-label, pragmatic randomised trial Prof John G Williams, FRCP, M Fasih Alam, PhD, Laith Alrubaiy, PhD, Ian Arnott, FRCP, Clare Clement, MSc, Prof David Cohen, MPhil, John N Gordon, DM, A Barney Hawthorne, DM, Mike Hilton, BA, Prof Hayley A Hutchings, PhD, Aida U Jawhari, PhD, Mirella Longo, PhD, John Mansfield, MD, Jayne M Morgan, BSc, Prof Frances Rapport, PhD, Anne C Seagrove, PhD, Shaji Sebastian, FRCP, Ian Shaw, MSc, Prof Simon P L Travis, FRCP, Alan Watkins, PhD The Lancet Gastroenterology & Hepatology Volume 1, Issue 1, Pages 15-24 (September 2016) DOI: 10.1016/S2468-1253(16)30003-6 Copyright © 2016 Williams et al. Open Access article distributed under the terms of CC BY Terms and Conditions

Figure 1 Patients included in primary outcome analysis BCC=basal-cell carcinoma. IBD=inflammatory bowel disease. RP=research professional. RCT=randomised controlled trial. The Lancet Gastroenterology & Hepatology 2016 1, 15-24DOI: (10.1016/S2468-1253(16)30003-6) Copyright © 2016 Williams et al. Open Access article distributed under the terms of CC BY Terms and Conditions

Figure 2 Patients included in follow-up PFQ=participant follow-up questionnaire. The Lancet Gastroenterology & Hepatology 2016 1, 15-24DOI: (10.1016/S2468-1253(16)30003-6) Copyright © 2016 Williams et al. Open Access article distributed under the terms of CC BY Terms and Conditions

Figure 3 CUCQ score (A), SF-6D score (B), and EQ-5D score (C) over time Data are mean score (95% CI) for each group. The Lancet Gastroenterology & Hepatology 2016 1, 15-24DOI: (10.1016/S2468-1253(16)30003-6) Copyright © 2016 Williams et al. Open Access article distributed under the terms of CC BY Terms and Conditions

Figure 4 Time to colectomy The Lancet Gastroenterology & Hepatology 2016 1, 15-24DOI: (10.1016/S2468-1253(16)30003-6) Copyright © 2016 Williams et al. Open Access article distributed under the terms of CC BY Terms and Conditions

Figure 5 Duration of treatment The Lancet Gastroenterology & Hepatology 2016 1, 15-24DOI: (10.1016/S2468-1253(16)30003-6) Copyright © 2016 Williams et al. Open Access article distributed under the terms of CC BY Terms and Conditions