Results Summary

What was the research about?

Crohn’s disease (CD) and ulcerative colitis (UC) are inflammatory bowel diseases that cause long-term diarrhea and stomach pain. CD and UC affect more than 1.5 million Americans. These illnesses can reduce quality of life and even lead to death.

CD and UC are usually treated with either steroids or anti-TNF drugs. Anti-TNF drugs block a specific part of the immune system. Both steroids and anti-TNF drugs have side effects. Little information exists about which treatment carries lower risks of death or serious side effects for patients with CD and UC.

The research team compared insurance claims from patients with CD and UC who took anti-TNF drugs or long-term steroids. The team wanted to learn about the risks and benefits of these treatments. The team then made a computer model to predict the impact of these treatments on quality of life for patients with CD.

What were the results?

For patients with CD, the risk of death was lower for those taking anti-TNF drugs than for those taking long-term steroids. Patients taking anti-TNF drugs also had fewer major heart problems and broken hips. But they had slightly more hospital visits for health problems related to CD. The computer model predicted that patients taking anti-TNF drugs would have a better quality of life than patients taking long-term steroids would.

For patients with UC, the study didn’t find a difference between the two treatments in the risk of death, heart problems, or broken hips. Patients taking anti-TNF drugs had more emergency surgeries and hospital visits for health problems related to UC than patients taking long-term steroids did.

What did the research team do?

The research team looked at Medicare and Medicaid billing claims from 13,256 patients with CD and UC who were taking long-term steroids or anti-TNF drugs. The team looked at how likely it was for patients to die or have serious side effects.

The team also surveyed 812 patients with CD about their disease symptoms, length of time on treatment, and risk of side effects. The research team used patients’ answers to predict patients’ quality of life for each treatment.

What were the limits of the study?

The research team couldn’t be sure the anti-TNF drugs caused the hospital visits and surgeries. For example, patients taking anti-TNF drugs may be sicker than patients taking long-term steroids. Also, doctors may have prescribed anti-TNF drugs as a last attempt to treat very sick patients with medicine before trying surgery.

The review of patients’ medical claims and the survey included two different groups of patients. If the patients in these two groups were different, such as in their age or how sick they were, then it could affect the quality-of-life results.

Future research could keep looking at quality-of-life concerns for patients with UC and CD.

How can people use the results?

Patients with inflammatory bowel diseases and their doctors may use the results to discuss the benefits and risks of using anti-TNF drugs or long-term steroids. Anti-TNF drugs may be safer than long-term steroids, particularly for patients with CD. For patients with UC, anti-TNF drugs didn’t show the same benefits as they did for patients with CD.

Final Research Report

View this project's final research report.

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Peer-Review Summary

Peer review of PCORI-funded research helps make sure the report presents complete, balanced, and useful information about the research. It also confirms that the research has followed PCORI’s Methodology Standards. During peer review, experts who were not members of the research team read a draft report of the research. These experts may include a scientist focused on the research topic, a specialist in research methods, a patient or caregiver, and a healthcare professional. Reviewers do not have conflicts of interest with the study.

The peer reviewers point out where the draft report may need revision. For example, they may suggest ways to improve how the research team analyzed its results or reported its conclusions. Learn more about PCORI’s peer-review process here.

In response to peer review, Lewis made changes including

  • Adding sections to the Methods describing changes from the original study protocol for Aims 2 and 3 of the study
  • Adding a supplemental table showing unweighted results of Aim 2 analyses, to show the associations before adjusting for confounding
  • Adding a section to the Discussion to address remaining knowledge gaps and future directions

Conflict of Interest Disclosures

Project Information

James Lewis, MD, MS
University of Pennsylvania
Patient Valued Comparative Effectiveness of Corticosteroids versus Anti-TNF Alpha Therapy for Inflammatory Bowel Disease

Key Dates

May 2013
March 2018

Study Registration Information


Has Results
Award Type
Health Conditions Health Conditions These are the broad terms we use to categorize our funded research studies; specific diseases or conditions are included within the appropriate larger category. Note: not all of our funded projects focus on a single disease or condition; some touch on multiple diseases or conditions, research methods, or broader health system interventions. Such projects won’t be listed by a primary disease/condition and so won’t appear if you use this filter tool to find them. View Glossary
Populations Populations PCORI is interested in research that seeks to better understand how different clinical and health system options work for different people. These populations are frequently studied in our portfolio or identified as being of interest by our stakeholders. View Glossary
Intervention Strategy Intervention Strategies PCORI funds comparative clinical effectiveness research (CER) studies that compare two or more options or approaches to health care, or that compare different ways of delivering or receiving care. View Glossary
State State The state where the project originates, or where the primary institution or organization is located. View Glossary
Last updated: January 25, 2023