Comparative Effectiveness of Biologics for Endoscopic Healing of the Ileum and Colon in Crohn's Disease

Neeraj Narula; Emily C L Wong; Parambir S Dulai; John K Marshall; Vipul Jairath; Walter Reinisch

doi:10.14309/ajg.0000000000001795

Comparative Effectiveness of Biologics for Endoscopic Healing of the Ileum and Colon in Crohn's Disease

Am J Gastroenterol. 2022 Jul 1;117(7):1106-1117. doi: 10.14309/ajg.0000000000001795. Epub 2022 Apr 15.

Authors

Neeraj Narula¹, Emily C L Wong¹, Parambir S Dulai², John K Marshall¹, Vipul Jairath³, Walter Reinisch⁴

Affiliations

¹ Division of Gastroenterology, Department of Medicine and Farncombe Family Digestive Health Research Institute, McMaster University, Hamilton ON, Canada.
² Division of Gastroenterology, Northwestern University, Chicago, Illinois, USA.
³ Division of Gastroenterology, Department of Medicine, Western University, London, ON, Canada.
⁴ Division of Gastroenterology and Hepatology, Department of Internal Medicine III, Medical University of Vienna, Vienna, Austria.

PMID: 35435862
DOI: 10.14309/ajg.0000000000001795

Abstract

Introduction: We compared the efficacy of adalimumab, infliximab, ustekinumab, and vedolizumab on the ability to achieve endoscopic healing (EH) after 1 year of therapy in moderate-severe Crohn's disease (CD).

Methods: This was a pooled analysis of patient-level data from 299 patients with CD from 4 clinical trials. Proportions of patients treated with each biologic were compared for achieving 1-year complete EH (Simple Endoscopic Score for CD [SES-CD] <3) and ileal and colonic EH separately (SES-CD = 0). Multivariate logistic regression was used to model the relationship between biologics and 1-year outcomes and adjusted for disease duration, concomitant corticosteroid use, and prior antitumor necrosis factor failure.

Results: Compared with vedolizumab (4/56 [7.1%]), adalimumab (17/61 [27.9%], adjusted odds ratio [OR]: 5.79, 95% confidence interval [CI]: 1.77-18.95, P = 0.004) and infliximab (39/141 [27.7%], aOR: 4.59, 95% CI: 1.48-14.22, P = 0.008) had superior rates of 1-year EH. No significant difference was observed between vedolizumab and ustekinumab. Similar results were observed among biologic-naive patients. Among patients with baseline ileal SES-CD ≥3, no significant differences were observed between biologics for 1-year ileal EH. However, for large (>0.5 cm) ileal ulcers, infliximab (20/49 [40.8%]) had superior rates of no ileal ulcers compared with vedolizumab (2/23 [8.7%], aOR: 5.39, 95% CI: 1.03-28.05, P = 0.045). No other differences were observed. For colonic disease, compared with ustekinumab (9/31 [29.0%]), adalimumab (30/48 [62.5%], aOR: 3.97, 95% CI: 1.45-10.90, P = 0.007) had superior rates of 1-year EH in the colon, with similar trends observed for infliximab (55/105 [52.4%], aOR: 2.08, 95% CI: 0.82-5.27, P = 0.121). No other differences were observed.

Discussion: In this post hoc analysis, TNF-α antagonists were overall superior to vedolizumab and ustekinumab for achieving 1-year EH in moderate-severe CD patients.

Trial registration: ClinicalTrials.gov NCT01369329 NCT02425111 NCT02096861.

MeSH terms

Adalimumab / therapeutic use
Biological Products* / therapeutic use
Colon / pathology
Crohn Disease* / pathology
Humans
Ileum / pathology
Infliximab / therapeutic use
Treatment Outcome
Tumor Necrosis Factor Inhibitors
Ulcer / chemically induced
Ustekinumab / therapeutic use

Substances

Biological Products
Tumor Necrosis Factor Inhibitors
Infliximab
Ustekinumab
Adalimumab

Associated data

ClinicalTrials.gov/NCT01369329
ClinicalTrials.gov/NCT02425111
ClinicalTrials.gov/NCT02096861