| Naslov: | Placebo rates in randomised clinical trials of ulcerative colitis : an individual patient data meta-analysis |
|---|
| Avtorji: | ID Solitano, Virginia (Avtor)
ID Hogan, Malcolm (Avtor)
ID Singh, Siddharth (Avtor)
ID Danese, Silvio (Avtor)
ID Peyrin-Biroulet, Laurent (Avtor)
ID Vuyyuru, Sudheer Kumar (Avtor)
ID MacDonald, John K (Avtor)
ID Zou, Guangyong (Avtor)
ID Hanžel, Jurij (Avtor), et al. |
|---|
| Datoteke: |  PDF - Predstavitvena datoteka, prenos (2,17 MB)
MD5: C531E72ED5DC4D145B98AE427A126264
 URL - Izvorni URL, za dostop obiščite https://academic.oup.com/ecco-jcc/article/19/10/jjaf191/8317441
|
|---|
| Jezik: | Angleški jezik |
|---|
| Tipologija: | 1.02 - Pregledni znanstveni članek |
|---|
| Organizacija: |  UKC LJ - Univerzitetni klinični center Ljubljana
|
|---|
| Povzetek: | 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. |
|---|
| Ključne besede: | inflammatory bowel disease, placebo effect, clinical trials, ulcerative colitis |
|---|
| Status publikacije: | Objavljeno |
|---|
| Verzija publikacije: | Objavljena publikacija |
|---|
| Leto izida: | 2025 |
|---|
| Št. strani: | str. 1-13 |
|---|
| Številčenje: | Vol. 19, iss. 10, [article no.] jjaf191 |
|---|
| PID: | 20.500.12556/DiRROS-25169  |
|---|
| UDK: | 616.3 |
|---|
| ISSN pri članku: | 1876-4479 |
|---|
| DOI: | 10.1093/ecco-jcc/jjaf191 |
|---|
| COBISS.SI-ID: | 257167107 |
|---|
| Opomba: | Nasl. z nasl. zaslona;
Opis vira z dne 14. 11. 2025;
|
|---|
| Datum objave v DiRROS: | 13.01.2026 |
|---|
| Število ogledov: | 211 |
|---|
| Število prenosov: | 145 |
|---|
| Metapodatki: |    |
|---|
|
:
|
Kopiraj citat |
|---|
| | | | Objavi na: |  |
|---|
Postavite miškin kazalec na naslov za izpis povzetka. Klik na naslov izpiše
podrobnosti ali sproži prenos. |
