Results Summary

What was the research about?

In autoimmune and inflammatory illnesses, the immune system attacks healthy cells by mistake. Examples are rheumatoid arthritis, ankylosing spondylitis, and vasculitis. Treatments include two types of medicines that limit inflammation and reduce damage to joints and tissues. Questions remain about how safe and effective these medicines are.

In this study, the research team wanted to see if they could use PCORnet® data to look at the safety and effectiveness of these medicines. PCORnet is a research network. It merges health records, prescription, and health insurance data from health systems, including hospitals and clinics. The team used the data to compare rates of infection among patients with different autoimmune illnesses taking the two types of medicines. They looked at rates of shingles and hospital stays due to infection.

What were the results?

The research team had problems getting consistent and complete data. For example, prescription data were missing for patients in some health systems.

Among patients with different autoimmune illnesses, the research team found that patients taking the two types of medicines had similar rates of shingles and hospital stays due to infection. But the rates varied among patients with different autoimmune illnesses. For example, among patients with illness related to blood vessels and bones:

  • Patients with vasculitis had the highest rate of shingles. Patients with ankylosing spondylitis had the lowest rate.
  • Patients with vasculitis had the highest rate of hospital stays due to infection. Patients with ankylosing spondylitis had the lowest rate.

What did the research team do?

The research team used PCORnet data. The data were from patients taking medicines to treat autoimmune illnesses between 2016 and 2020.

Patients with autoimmune illnesses gave input throughout the study.

What were the limits of the study?

Many patients in the study didn’t have prescription or refill data recorded. Results may have differed with complete data.

Future research could look at ways to reduce missing prescription data.

How can people use the results?

Researchers can consider these results when using data from research networks. Doctors and patients can use these results when considering medicines for autoimmune illnesses.

ArthritisPower, IBD Partners, and Vasculitis PPRN formerly were Network Partners in PCORnet®, the National Patient-Centered Clinical Research Network. PCORnet® has been developed with funding from the Patient-Centered Outcomes Research Institute (PCORI®).

Final Research Report

View this project's final research report.

Journal Citations

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 assesses how the project addressed PCORI’s Methodology Standards. During peer review, experts read a draft report of the research and provide comments about the report. These experts may include a scientist focused on the research topic, a specialist in research methods, a patient or caregiver, and a healthcare professional. These reviewers cannot 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 descriptions of the conduct of the study or to clarify the connection between results and conclusions. Sometimes, awardees revise their draft reports twice or more to address all of the reviewers’ comments.   

Peer reviewers commented and the researchers made changes or provided responses. Those comments and responses included the following: 

  • The reviewers noted that the researchers overstated their conclusions in saying that the initiation of biologic agents led to significant, clinically important improvements because there was no comparison group to indicate that the improvements were the result of the biologics. The researchers revised their conclusions to remove this language. 

  • The reviewers thanked the researchers for providing the important account of difficulties they had completing the study. They requested more information about the challenges the researchers faced in obtaining refill information for medications overall and specifically for injectables. The researchers added information about their experience to the discussion and in particular when discussing future research possibilities. 

  • The reviewers encouraged the researchers to discuss the particular difficulties they experienced in gathering data elements collected outside of the PCORnet common data model as this information would be helpful for future research. The researchers revised the report to specify which data came from the PCORnet databases and which data came from outside, or “sidecar,” sources. 

  • The reviewers noted that the researchers used a relatively small sample of patients whose data could be linked to Medicare claims that was likely to be very different from the overall sample of patients collected from all sites in the clinical research networks. The researchers agreed and revised their interpretation of results to take into account the differences between the two patient groups. 

 

Conflict of Interest Disclosures

Project Information

Jeffrey R. Curtis, MD, MPH, MS
University of Alabama at Birmingham
$2,531,263
10.25302/10.2023.PPRND.150732163
Harnessing PCORnet to Study Comparative Effectiveness and Safety of Biologic Therapies

Key Dates

March 2016
April 2023
2016
2023

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: February 20, 2024