| Title: | Placebo rates in randomised clinical trials of ulcerative colitis : an individual patient data meta-analysis |
|---|
| Authors: | ID Solitano, Virginia (Author)
ID Hogan, Malcolm (Author)
ID Singh, Siddharth (Author)
ID Danese, Silvio (Author)
ID Peyrin-Biroulet, Laurent (Author)
ID Vuyyuru, Sudheer Kumar (Author)
ID MacDonald, John K (Author)
ID Zou, Guangyong (Author)
ID Hanžel, Jurij (Author), et al. |
|---|
| Files: |  PDF - Presentation file, download (2,17 MB)
MD5: C531E72ED5DC4D145B98AE427A126264
 URL - Source URL, visit https://academic.oup.com/ecco-jcc/article/19/10/jjaf191/8317441
|
|---|
| Language: | English |
|---|
| Typology: | 1.02 - Review Article |
|---|
| Organization: |  UKC LJ - Ljubljana University Medical Centre
|
|---|
| Abstract: | Background and aims: We assessed placebo rates and associated factors using individual patient data (IDP) from randomised clinical trials (RCTs) in ulcerative colitis (UC). Methods: 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 < 0·05) were identified using regression analyses. Primary outcomes were clinical response and remission. Results: 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 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 one-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. Multi-centre trials have lower placebo effects than single-centre trials. Conclusions: 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. |
|---|
| Keywords: | inflammatory bowel disease, placebo effect, clinical trials, ulcerative colitis |
|---|
| Publication status: | Published |
|---|
| Publication version: | Version of Record |
|---|
| Year of publishing: | 2025 |
|---|
| Number of pages: | str. 1-13 |
|---|
| Numbering: | Vol. 19, iss. 10, [article no.] jjaf191 |
|---|
| PID: | 20.500.12556/DiRROS-25169  |
|---|
| UDC: | 616.3 |
|---|
| ISSN on article: | 1876-4479 |
|---|
| DOI: | 10.1093/ecco-jcc/jjaf191 |
|---|
| COBISS.SI-ID: | 257167107 |
|---|
| Note: | Nasl. z nasl. zaslona;
Opis vira z dne 14. 11. 2025;
|
|---|
| Publication date in DiRROS: | 13.01.2026 |
|---|
| Views: | 215 |
|---|
| Downloads: | 146 |
|---|
| Metadata: |    |
|---|
|
:
|
Copy citation |
|---|
| | | | Share: |  |
|---|
Hover the mouse pointer over a document title to show the abstract or click
on the title to get all document metadata. |
