Comparative Effectiveness of Biologic Therapies in Preventing Penetrating Complications in Patients With Crohn's Disease

Clin Gastroenterol Hepatol. 2024 Feb;22(2):377-385.e5. doi: 10.1016/j.cgh.2023.08.017.Epub 2023 Sep 4.


Jeffrey D McCurdy 1Dustin Stwalley 2Margaret A Olsen 2Parakkal Deepak 3


Author information

1Department of Medicine, University of Ottawa, Ottawa, Canada; The Ottawa Hospital Research Institute, Ottawa, Canada. Electronic address: jmccurdy@toh.ca.

2Center for Administrative Data Research, Institute for Informatics, Washington University in St. Louis School of Medicine, St. Louis, Missouri.

3Division of Gastroenterology, Washington University in St. Louis School of Medicine, St. Louis, Missouri. Electronic address: deepak.parakkal@wustl.edu.


Background & aims: Comparative effectiveness of biologics in preventing penetrating disease (PD) in Crohn's disease (CD) is not well established. We compared the risk of developing luminal and perianal PD (LPD and PPD) between biologics used as first-line therapies.

Methods: Adults (>17 years) with CD who initiated their first biologic (anti-tumor necrosis factor [anti-TNF], ustekinumab [UST], or vedolizumab [VDZ]) were identified from Merative Commercial Database (2006 and 2020). We excluded preexisting PD using a minimum look-back period of 1 year. Cohorts were balanced by inverse probability of treatment weighting based on age, sex, comorbidities, prior CD surgery, and CD severity. Pairwise comparisons were performed by Cox proportional hazards models, adjusted for immunomodulator exposure, and with biologic exposure treated as a time-dependent variable based on a medication possession ratio of 0.8.

Results: Our analysis included 40,693 patients: 93% anti-TNF, 3% UST, and 4% VDZ. After inverse probability of treatment weighting all comparisons were well balanced. Anti-TNF was protective against LPD (hazard ratio, 0.66; 95% confidence interval, 0.55-0.78; P < .0001) and PPD (hazard ratio, 0.88; 95% confidence interval, 0.80-0.96; P = .0045) compared with VDZ and LPD (hazard ratio, 0.37; 95% confidence interval, 0.30-0.46; P < .0001) compared with UST. There were no significant differences in the risk of LPD and PPD between VDZ and UST. These results were similar after limiting the study period to after 2016.

Conclusions: Anti-TNF therapy was associated with a lower risk of LPD and PPD compared with VDZ, and lower risk of LPD compared with UST. Further studies are needed to validate these findings and to determine potential reasons for these differences.

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