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.
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 |
 |
Up to 1-year follow-up for primary outcomes |
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