# Effectivenes, Safety, and Patient Preferences of Infliximab Biosimilar Medications for Inflammatory Bowel Disease

> **NIH VA I01** · MICHAEL E DEBAKEY VA MEDICAL CENTER · 2020 · —

## Abstract

Background: Biologic medications (biologics) are highly effective for diseases of the immune system, cancers,
and other conditions; however, their high expense is a barrier to care and a burden to the healthcare system.
Biologics cannot be exactly copied as “generic” medications. Biosimilars- similar, but not identical versions of
biologic medications- are approved with large potential cost savings. However, VA providers and patients have
concerns regarding biosimilar switching safety and effectiveness as disease-specific randomized controlled
trials are not required for approval. Significance/Impact: Antagonists to tumor necrosis factor-α (Anti-TNFs)
are the largest class of biologics with biosimilars where switching may be feasible to reduce costs; however
how to safely and effectively integrate their use in a manner acceptable to patients is unknown. This proposal
addresses the VA HSR priority of veteran safety, the ORD-wide research priority of increasing substantial real-
world impact of VA research, and uses cross-cutting HSR methods of health systems engineering through a
learning healthcare system. Innovation: Crohn’s disease (CD) and ulcerative colitis (UC) are the 1st and 2nd
most common indications for Anti-TNFs in the VA and can serve as a model for a learning healthcare system
approach for mitigation of adverse events related to biosimilar switching. Specific Aims: Aim 1a: To compare
rates of adverse events in CD and UC patients continued on Anti-TNF originator to those switched to
biosimilar. Aim 1b: To compare rates of CD or UC exacerbation in patients continued on Anti-TNF originator
to those switched to biosimilar. Aim 2: To compare the accuracy and calibration of 2a) traditional regression
models vs. 2b) machine learning models for predicting medication related adverse event related to Anti-TNF in
VA users with CD and UC. Aim 3: To use deliberative democracy methods to engage Veterans, to elicit their
preference regarding “like" medication switch programs with and without their knowledge and to develop
consensus around treatment approaches. Methodology: Aim 1 will be achieved through a retrospective
cohort study of CD and UC patients who received Anti-TNF from the national VA datasets from 2017-2019.
Adverse events and exacerbations will be determined using a combination of administrative data and manual
chart review. Analyses for Aim 1 will proceed by Poisson regression using GEE. Adjusted event rate ratios of
patients switched to biosimilar compared to those who continued on originator biosimilar will be calculated with
95% confidence intervals and Wald p-values will be derived from the regression model estimates. Prediction of
patients who have adverse events to Anti-TNF will inform selection of appropriate therapy, and guidance of
patients for biosimilar switching. For Aim 2, both traditional regression models and machine learning models
will be constructed to identify which model will be better for predicting Anti-TNF relat...

## Key facts

- **NIH application ID:** 9835174
- **Project number:** 1I01HX003028-01
- **Recipient organization:** MICHAEL E DEBAKEY VA MEDICAL CENTER
- **Principal Investigator:** Jason Ken Hou
- **Activity code:** I01 (R01, R21, SBIR, etc.)
- **Funding institute:** VA
- **Fiscal year:** 2020
- **Award amount:** —
- **Award type:** 1
- **Project period:** 2020-02-01 → 2024-01-31

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/9835174

## Citation

> US National Institutes of Health, RePORTER application 9835174, Effectivenes, Safety, and Patient Preferences of Infliximab Biosimilar Medications for Inflammatory Bowel Disease (1I01HX003028-01). Retrieved via AI Analytics 2026-05-25 from https://api.ai-analytics.org/grant/nih/9835174. Licensed CC0.

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