Epidemiology of pre-diagnosed rheumatoid arthritis and early classification of high severity at diagnosis

Study type
Protocol
Date of Approval
Study reference ID
17_246
Lay Summary

This study will describe the demographics, comorbidities, diagnostic tests, rheumatoid arthritis symptoms, healthcare utilization, and prescription treatments for English rheumatoid arthritis (RA) patients in the 3-year period prior to initial diagnosis. This information will be compared to a sample English primary care patients with no history of inflammatory arthritis. We will also assess the same variables among RA patients with both high- and lower-severity disease at the time of diagnosis and create a statistical model to determine whether we can identify RA patients who present with high severity earlier in the disease course, which could help reduce the risk of irreversible joint damage and disability and increase chances of achieving remission.

Technical Summary

This study will describe the demographics, comorbidities, diagnostic tests, rheumatoid arthritis symptoms, healthcare utilization, and prescription treatments for English rheumatoid arthritis (RA) patients in the three years prior to RA diagnosis to assess variables associated with incident RA diagnosis and high-severity RA at diagnosis. This information may identify potential early predictors of RA or patients more likely to be diagnosed with high severity.

This study will also develop a statistical model of factors associated with high RA severity at the time of diagnosis. We will compare both LASSO regression and elastic net regularization models. This information may assist clinicians in improving clinical management and targeted therapeutic strategies for RA patients who present with high disease severity. It may also lead to early detection of RA in patients who would otherwise be diagnosed in a more severe state. RA patients identified and properly treated in the less-severe disease stages have the greatest chance of avoiding irreversible joint damage and achieving long-term remission.

Health Outcomes to be Measured

Rheumatoid arthritis incidence; Rheumatoid arthritis severity at diagnosis.

Collaborators

Kristen Ricchetti-Masterson - Chief Investigator - GlaxoSmithKline - USA
Kristen Ricchetti-Masterson - Corresponding Applicant - GlaxoSmithKline - USA
Brian Pence - Collaborator - University of North Carolina at Chapel Hill
James C. Thomas - Collaborator - University of North Carolina at Chapel Hill
Jennifer L. Lund - Collaborator - University of North Carolina at Chapel Hill
John Logie - Collaborator - GlaxoSmithKline Research & Development Limited (UK)
Leigh Callahan - Collaborator - University of North Carolina at Chapel Hill
Liyuan Ma - Collaborator - GSK
Rachel E. Williams - Collaborator - GSK

Linkages

HES Accident and Emergency;HES Admitted Patient Care;HES Diagnostic Imaging Dataset;HES Outpatient;Patient Level Index of Multiple Deprivation;Pregnancy Register