Project Summary

This research project is in progress. PCORI will post the research findings on this page within 90 days after the results are final. In the meantime, results have been published in peer-reviewed journals, as listed below.

What is the research about?

The immune system works to protect the body from infections. In people with autoimmune or inflammatory diseases, the immune system attacks healthy cells by mistake. More than 80 types of autoimmune and inflammatory diseases exist. Examples include rheumatoid arthritis, inflammatory bowel disease, and vasculitis.

Patients with autoimmune and inflammatory diseases may have symptoms such as such as pain, swelling, and fatigue. Clinicians, such as doctors and nurse practitioners, can prescribe medicines to manage symptoms. But clinicians may not know how medicines for these diseases compare over the long term to manage symptoms or how they may increase the risk of other health problems.

In this study, the research team is comparing medicines, or combinations of medicines, for autoimmune and inflammatory diseases. They are looking at how well the medicines work to treat things that matter to patients, like fatigue, as well as how often patients have complications like infection or stroke.

Who can this research help?

Patients and clinicians can use results from this study when considering how to treat autoimmune or inflammatory diseases.

What is the research team doing?

The research team is using patient data from 58,000 patients in seven research networks. Five networks focus on autoimmune and inflammatory conditions; two are general networks that collect patient data from multiple hospitals. The networks share electronic healthcare data that come from hospital and clinic medical records. The team is using these data to compare how well children and adult patients respond to medicines. The team is also looking at how often patients who use medicines are diagnosed with serious infections, heart attack, stroke, and cancer. At the start of treatment and again three to six months later, patients fill out surveys. The surveys ask patients about how they feel and what activities they can do. For example, the surveys ask about patients’ level of fatigue and how much pain interferes with daily life.

Patients are working with the research team to help design the study.  

Research methods at a glance

Design Elements Description
Design Observational: prospective cohort study
Population Children and adults with autoimmune and inflammatory conditions
Interventions/
Comparators
Biologic and non-biologic medicines for autoimmune and inflammatory conditions
Outcomes

Primary: serious infections, heart attack, stroke, cancer, autoimmune and inflammatory disease-specific outcomes, herpes zoster

Secondary: fatigue, pain interference, physical function, social role satisfaction or participation, medication persistence or discontinuation, glucocorticoid discontinuation or dose reduction

Timeframe Up to 1-year follow-up for primary outcomes

Project Information

Jeffrey R. Curtis, MD, MPH, MS
University of Alabama at Birmingham
$2,541,404
Harnessing PCORnet to Study Comparative Effectiveness and Safety of Biologic Therapies

Key Dates

March 2016
April 2023
2016

Study Registration Information

Tags

Has Results
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
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: August 23, 2022