{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,10,29]],"date-time":"2026-10-29T23:31:13Z","timestamp":1793316673769,"version":"4.5.0"},"reference-count":39,"publisher":"Oxford University Press (OUP)","issue":"10","license":[{"start":{"date-parts":[[2025,11,9]],"date-time":"2025-11-09T00:00:00Z","timestamp":1762646400000},"content-version":"vor","delay-in-days":39,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0\/"}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":[],"published-print":{"date-parts":[[2025,11,8]]},"abstract":"<jats:title>Abstract<\/jats:title>\n                  <jats:sec>\n                    <jats:title>Background and Aims<\/jats:title>\n                    <jats:p>We assessed placebo rates and associated factors using individual patient data (IDP) from randomized clinical trials (RCTs) in ulcerative colitis (UC).<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Methods<\/jats:title>\n                    <jats:p>We conducted an IPD meta-analysis using Vivli and Yale University Open Data Access data-sharing platforms. Phase 2 and 3 RCTs of advanced biologics in adults with moderate-to-severe UC published since 2010 were included. Pooled placebo rates and 95% CIs were estimated using one- and two-stage meta-analytical approaches. Significant patient-level factors (P\u2009&amp;lt;\u2009.05) were identified using regression analyses. Primary outcomes were clinical response and remission.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Results<\/jats:title>\n                    <jats:p>Data were available for 1703 patients from nine studies. For induction trials, overall placebo response and remission rates were 33% (95% CI 29%-38%) and 9% (95% CI 7%-11%). Overall placebo response and remission rates in maintenance trials were 28% (95% CI 18%-41%) and 14% (95% CI 9%-20%). A lower body mass index reduced the odds of placebo response and remission, while higher baseline albumin levels and left-sided (compared to extensive) UC increased the odds of these outcomes. A 1-point increase in the Mayo Clinic Score (MCS) and adapted MCS was associated with a 26% and 27% reduction in odds of clinical remission. For induction trials, prior biologic exposure was associated with lower odds of response and remission. Multicenter trials have lower placebo effects than single-center trials.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Conclusions<\/jats:title>\n                    <jats:p>These results enable future trials to incorporate design elements that reduce placebo rates as well as a precise benchmark for expected rates in clinical trials that do not include placebo.<\/jats:p>\n                  <\/jats:sec>","DOI":"10.1093\/ecco-jcc\/jjaf191","type":"journal-article","created":{"date-parts":[[2025,11,9]],"date-time":"2025-11-09T20:35:49Z","timestamp":1762720549000},"source":"Crossref","is-referenced-by-count":5,"title":["Placebo rates in randomized clinical trials of ulcerative colitis: an individual patient data meta-analysis"],"prefix":"10.1093","volume":"19","author":[{"ORCID":"https:\/\/orcid.org\/0000-0002-2935-6778","authenticated-orcid":false,"given":"Virginia","family":"Solitano","sequence":"first","affiliation":[{"name":"Division of Gastroenterology, Western University , London, Ontario N6A 3K7,","place":["Canada"]},{"name":"Division of Gastroenterology and Gastrointestinal Endoscopy, IRCCS Ospedale San Raffaele, Universit\u00e0 Vita-Salute San Raffaele , Milan 20132,","place":["Italy"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Malcolm","family":"Hogan","sequence":"additional","affiliation":[{"name":"Alimentiv Inc , London, Ontario N6A 5B6,","place":["Canada"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Siddharth","family":"Singh","sequence":"additional","affiliation":[{"name":"Division of Gastroenterology, Department of Medicine, University of California, San Diego , La Jolla, CA 92037,","place":["United States"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-7341-1351","authenticated-orcid":false,"given":"Silvio","family":"Danese","sequence":"additional","affiliation":[{"name":"Division of Gastroenterology and Gastrointestinal Endoscopy, IRCCS Ospedale San Raffaele, Universit\u00e0 Vita-Salute San Raffaele , Milan 20132,","place":["Italy"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Laurent","family":"Peyrin-Biroulet","sequence":"additional","affiliation":[{"name":"Department of Gastroenterology, Nancy University Hospital , Vand\u0153uvre-l\u00e8s-Nancy F-54500,","place":["France"]},{"name":"INFINY Institute, Nancy University Hospital , Vand\u0153uvre-l\u00e8s-Nancy F-54500,","place":["France"]},{"name":"Groupe Hospitalier Priv\u00e9 Ambroise Par\u00e9 \u2013 Hartmann Paris IBD Center , Neuilly sur Seine 92200,","place":["France"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Sudheer","family":"Vuyyuru","sequence":"additional","affiliation":[{"name":"Division of Gastroenterology, Western University , London, Ontario N6A 3K7,","place":["Canada"]},{"name":"Alimentiv Inc , London, Ontario N6A 5B6,","place":["Canada"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"John K","family":"Macdonald","sequence":"additional","affiliation":[{"name":"Alimentiv Inc , London, Ontario N6A 5B6,","place":["Canada"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Guangyong","family":"Zou","sequence":"additional","affiliation":[{"name":"Alimentiv Inc , London, Ontario N6A 5B6,","place":["Canada"]},{"name":"Department of Epidemiology and Biostatistics, Western University , London, Ontario N6A 5C1,","place":["Canada"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-4374-3042","authenticated-orcid":false,"given":"Yuhong","family":"Yuan","sequence":"additional","affiliation":[{"name":"Lawson Health Research Institute , London, Ontario N6A 4V2,","place":["Canada"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Bruce E","family":"Sands","sequence":"additional","affiliation":[{"name":"Dr. Henry D. Janowitz Division of Gastroenterology, Icahn School of Medicine at Mount Sinai , New York, NY 10029,","place":["United States"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-5247-940X","authenticated-orcid":false,"given":"Remo","family":"Panaccione","sequence":"additional","affiliation":[{"name":"Division of Gastroenterology & Hepatology, University of Calgary , Calgary, Alberta T2N 4Z6,","place":["Canada"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Brian G","family":"Feagan","sequence":"additional","affiliation":[{"name":"Division of Gastroenterology, Western University , London, Ontario N6A 3K7,","place":["Canada"]},{"name":"Alimentiv Inc , London, Ontario N6A 5B6,","place":["Canada"]},{"name":"Department of Epidemiology and Biostatistics, Western University , London, Ontario N6A 5C1,","place":["Canada"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-3158-8014","authenticated-orcid":false,"given":"Jurij","family":"Hanzel","sequence":"additional","affiliation":[{"name":"Alimentiv Inc , London, Ontario N6A 5B6,","place":["Canada"]},{"name":"Department of Gastroenterology, University Medical Centre Ljubljana, Faculty of Medicine, University of Ljubljana , Ljubljana 1000,","place":["Slovenia"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Rocio","family":"Sedano","sequence":"additional","affiliation":[{"name":"Division of Gastroenterology, Western University , London, Ontario N6A 3K7,","place":["Canada"]},{"name":"Alimentiv Inc , London, Ontario N6A 5B6,","place":["Canada"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Parambir","family":"Dulai","sequence":"additional","affiliation":[{"name":"Division of Gastroenterology, Northwestern University , Chicago, IL 60611,","place":["United States"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-1536-8436","authenticated-orcid":false,"given":"Neeraj","family":"Narula","sequence":"additional","affiliation":[{"name":"Department of Medicine, Division of Gastroenterology, Farncombe Family Digestive Health Research Institute, McMaster University , Hamilton, Ontario L8S 4K1,","place":["Canada"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-4698-9948","authenticated-orcid":false,"given":"Christopher","family":"Ma","sequence":"additional","affiliation":[{"name":"Alimentiv Inc , London, Ontario N6A 5B6,","place":["Canada"]},{"name":"Division of Gastroenterology & Hepatology, University of Calgary , Calgary, Alberta T2N 4Z6,","place":["Canada"]},{"name":"Department of Community Health Sciences, University of Calgary , Calgary, Alberta T2N 4N1,","place":["Canada"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-1092-0033","authenticated-orcid":false,"given":"Vipul","family":"Jairath","sequence":"additional","affiliation":[{"name":"Division of Gastroenterology, Western University , London, Ontario N6A 3K7,","place":["Canada"]},{"name":"Alimentiv Inc , London, Ontario N6A 5B6,","place":["Canada"]},{"name":"Department of Epidemiology and Biostatistics, Western University , London, Ontario N6A 5C1,","place":["Canada"]}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"286","published-online":{"date-parts":[[2025,11,9]]},"reference":[{"key":"2026071517011722500_jjaf191-B1","doi-asserted-by":"crossref","first-page":"607","DOI":"10.1093\/ecco-jcc\/jjw004","article-title":"Systematic review and meta-analysis: Placebo rates in induction and maintenance trials of ulcerative colitis","volume":"10","author":"Jairath","year":"2016","journal-title":"J Crohns 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