S1660 Real-World Comparative Effectiveness and Safety of Vedolizumab Versus Adalimumab in Adult Crohn’s Disease: A Nationwide Retrospective Cohort Study

Introduction: Crohn’s disease (CD) is a chronic and debilitating disease with a waxing and waning nature. Biologics have been a mainstay of therapeutics with both Vedolizumab (VDZ) and adalimumab (ADB) showing superiority to placebo in inducing remission. Direct comparisons were only made in small scale trials and further meta-analysis showed conflicting results on clinical remission and steroid free remission. We aim to Utilize nation-wide data to compare between (VDZ) and (ADB). Methods: This is a retrospective cohort study utilizing the TriNetX database on adult patients >18 years of age with CD, initiated VDZ or ADB between 1/2015 and 12/2023. The Outcomes are the risk developing colorectal cancer (CRC) and fistulizing complications (FC). Time to switch to a different biologic, steroid use (SU), and developing (FC). Number of instances of Emergency room (ER) visits. Fecal calprotectin levels and CRP levels. Serious adverse events of sepsis, lymphoma or opportunistic infections. Propensity score matching (PSM) performed for demographics, prior medication use, confounding comorbidities. Results expressed in the form of risk difference (RD). Time to event endpoints using Kaplan-Meier curves and Cox proportional hazards models reported as hazard ratio (HR) and log-rank P values. Results: After matching, the cohort included 13661 CD patients in VDZ and ADB groups. The RD of developing CRC and FC was not significant. VDZ was showed a higher hazard of switching to a different biologic (HR 1.27, 95% CI 1.19–1.35; log-rank P < 0.0001) and systemic steroid use (HR 1.32, 95% CI 1.291,1.367; log-rank P < 0.0001). There was a significant increase in the risk of developing lymphomas for VDZ (RD 0.644%, 95% CI 0.381,0.907, P < 0.0001) and opportunistic infections (RD 1.537%, 95% CI 0.576,2.499, P = 0.0017). Instances of Emergency room (ER) visits. fecal calprotectin or CRP levels, sepsis rates were not significantly different. Conclusion: Our Study is the first of this magnitude comparing to popular biologics. ADB in comparison to VDZ showed more robustness as regards to steroid free remission and the likelihood of switching to a different biologic. ADB is also showing lower risk of adverse events in the form of lymphoma and opportunistic infections.

Authors

Publication Details

Journal
The American Journal of Gastroenterology
Published
2025-10-01
DOI
https://doi.org/10.14309/01.ajg.0001134100.64655.f0
Primary Topic
Inflammatory Bowel Disease
Type
article
Field-Weighted Citation Impact
0.00
Controls
|||
ALL TIME
JAN
FEB
MAR
APR
MAY
JUN
JUL
AUG
SEP
OCT
article

S1660 Real-World Comparative Effectiveness and Safety of Vedolizumab Versus Adalimumab in Adult Crohn’s Disease: A Nationwide Retrospective Cohort Study

Sameh Gomaa, Hatem Ahmed, Imad Alabdul Razzak, Eyad Abdulrazzak
The American Journal of Gastroenterology
Inflammatory Bowel Disease
article

S1660 Real-World Comparative Effectiveness and Safety of Vedolizumab Versus Adalimumab in Adult Crohn’s Disease: A Nationwide Retrospective Cohort Study

Sameh Gomaa, Hatem Ahmed, Imad Alabdul Razzak, Eyad Abdulrazzak
article en

Abstract

Introduction: Crohn’s disease (CD) is a chronic and debilitating disease with a waxing and waning nature. Biologics have been a mainstay of therapeutics with both Vedolizumab (VDZ) and adalimumab (ADB) showing superiority to placebo in inducing remission. Direct comparisons were only made in small scale trials and further meta-analysis showed conflicting results on clinical remission and steroid free remission. We aim to Utilize nation-wide data to compare between (VDZ) and (ADB). Methods: This is a retrospective cohort study utilizing the TriNetX database on adult patients >18 years of age with CD, initiated VDZ or ADB between 1/2015 and 12/2023. The Outcomes are the risk developing colorectal cancer (CRC) and fistulizing complications (FC). Time to switch to a different biologic, steroid use (SU), and developing (FC). Number of instances of Emergency room (ER) visits. Fecal calprotectin levels and CRP levels. Serious adverse events of sepsis, lymphoma or opportunistic infections. Propensity score matching (PSM) performed for demographics, prior medication use, confounding comorbidities. Results expressed in the form of risk difference (RD). Time to event endpoints using Kaplan-Meier curves and Cox proportional hazards models reported as hazard ratio (HR) and log-rank P values. Results: After matching, the cohort included 13661 CD patients in VDZ and ADB groups. The RD of developing CRC and FC was not significant. VDZ was showed a higher hazard of switching to a different biologic (HR 1.27, 95% CI 1.19–1.35; log-rank P < 0.0001) and systemic steroid use (HR 1.32, 95% CI 1.291,1.367; log-rank P < 0.0001). There was a significant increase in the risk of developing lymphomas for VDZ (RD 0.644%, 95% CI 0.381,0.907, P < 0.0001) and opportunistic infections (RD 1.537%, 95% CI 0.576,2.499, P = 0.0017). Instances of Emergency room (ER) visits. fecal calprotectin or CRP levels, sepsis rates were not significantly different. Conclusion: Our Study is the first of this magnitude comparing to popular biologics. ADB in comparison to VDZ showed more robustness as regards to steroid free remission and the likelihood of switching to a different biologic. ADB is also showing lower risk of adverse events in the form of lymphoma and opportunistic infections.

The American Journal of GastroenterologyVol. 120(10S2)
Openalex Percentile: Top 59%
Inflammatory Bowel Disease
AI Navigator

Ask Laika to Summarize, Analyze, and Connect papers live on the map.

Summarize Papers & Methodologies

Extract key findings, datasets, and comparative methods across publications.

Benchmark Rankings & Visual Analytics

Rank top research institutions, authors, funders, topics, and journals by Field-Weighted Citation Impact (FWCI) and paper volume with instant charts.

Connect Distant Disciplines

Bridge topological clusters on the map to find hidden collaborative intersections.