Switching Within vs. Outside the TNFi Class Following TNFi Failure in Patients With Crohn’s Disease (CD) in Europe: A Meta-Analysis of Real-World Outcomes
Author(s)
Keltie McDonald, PhD1, Evi Zhuleku2, Ottavio Secchi, PharmD3, Bernd Bokemeyer, Prof. Dr. med.4, Daniel Wirth, Dr.5.
1Cytel, Abingdon, United Kingdom, 2Berlin, Germany, 3Janssen, Milan, Italy, 4Interdisziplinäres Crohn Colitis Centrum Minden - ICCCM, Minden, Germany, 5Janssen-Cilag GmbH, Neuss, Germany.
1Cytel, Abingdon, United Kingdom, 2Berlin, Germany, 3Janssen, Milan, Italy, 4Interdisziplinäres Crohn Colitis Centrum Minden - ICCCM, Minden, Germany, 5Janssen-Cilag GmbH, Neuss, Germany.
OBJECTIVES: Comparative evidence on the effectiveness of different biologics for the treatment of Crohn’s Disease (CD) following failure on tumor necrosis factor inhibitors (TNFis) remains limited. This meta-analysis compares real-world outcomes between within-class switchers (switching to another TNFi) and outside-class switchers (switching to a non-TNFi biologic) after initial TNFi failure across four European studies.
METHODS: Adult patients with CD who initiated TNFi treatment (adalimumab, infliximab) and switched to a different biologic were identified in real-world datasets in Germany (AOK PLUS, GWQ ServicePlus), Italy (Local Health Units) and the UK (IBD Registry) from 01/01/2014 to 31/03/2021. A French dataset (EPITHERA) was included as a sensitivity analysis but excluded here due to different data and endpoint definitions. Patients who switched to a different TNFi vs. non-TNFi (ustekinumab, vedolizumab) were defined as within-class switchers (WCS) vs. outside-class switchers (OCS), respectively. Patients were followed ≥12 months from index (switch date) until loss-to-follow-up, death or end of study period. Time to discontinuation, second treatment switch and prolonged corticosteroid therapy (derived from Cox regression with inverse probability of treatment weighting [IPTW]) were meta-analyzed across datasets.
RESULTS: Of 672 patients (300 WCS, 372 OCS) identified across datasets, mean age after IPTW was 39.0 years (39.1 WCS, 38.9 OCS), with 58.5% females (60.7% WCS, 56.6% OCS). WCS were significantly more likely to discontinue therapy (pooled HR: 1.56, 95%-CI [confidence interval] 1.24-1.96, p<0.001; I2 = 0%, p=0.585), switch a second time (pooled HR: 2.05, 95%-CI: 1.50-2.79, p<0.001; I2 = 0%, p=0.552) and initiate prolonged corticosteroid therapy (pooled HR: 1.52, 95%-CI: 1.19-1.94, p<0.001; I2 = 0%, p=0.768).
CONCLUSIONS: This meta-analysis shows that, across different populations in Europe, patients with CD experience better real-world outcomes when switching to a non-TNFi biologic compared to a different TNFi following failure on initial TNFi therapy.
METHODS: Adult patients with CD who initiated TNFi treatment (adalimumab, infliximab) and switched to a different biologic were identified in real-world datasets in Germany (AOK PLUS, GWQ ServicePlus), Italy (Local Health Units) and the UK (IBD Registry) from 01/01/2014 to 31/03/2021. A French dataset (EPITHERA) was included as a sensitivity analysis but excluded here due to different data and endpoint definitions. Patients who switched to a different TNFi vs. non-TNFi (ustekinumab, vedolizumab) were defined as within-class switchers (WCS) vs. outside-class switchers (OCS), respectively. Patients were followed ≥12 months from index (switch date) until loss-to-follow-up, death or end of study period. Time to discontinuation, second treatment switch and prolonged corticosteroid therapy (derived from Cox regression with inverse probability of treatment weighting [IPTW]) were meta-analyzed across datasets.
RESULTS: Of 672 patients (300 WCS, 372 OCS) identified across datasets, mean age after IPTW was 39.0 years (39.1 WCS, 38.9 OCS), with 58.5% females (60.7% WCS, 56.6% OCS). WCS were significantly more likely to discontinue therapy (pooled HR: 1.56, 95%-CI [confidence interval] 1.24-1.96, p<0.001; I2 = 0%, p=0.585), switch a second time (pooled HR: 2.05, 95%-CI: 1.50-2.79, p<0.001; I2 = 0%, p=0.552) and initiate prolonged corticosteroid therapy (pooled HR: 1.52, 95%-CI: 1.19-1.94, p<0.001; I2 = 0%, p=0.768).
CONCLUSIONS: This meta-analysis shows that, across different populations in Europe, patients with CD experience better real-world outcomes when switching to a non-TNFi biologic compared to a different TNFi following failure on initial TNFi therapy.
Conference/Value in Health Info
2025-11, ISPOR Europe 2025, Glasgow, Scotland
Value in Health, Volume 28, Issue S2
Code
RWD177
Topic
Clinical Outcomes, Real World Data & Information Systems
Disease
Biologics & Biosimilars, Gastrointestinal Disorders, Systemic Disorders/Conditions (Anesthesia, Auto-Immune Disorders (n.e.c.), Hematological Disorders (non-oncologic), Pain)