Predicting Hospitalized Infection in Patients With Chronic Inflammatory Arthritis Treated With Biological Drugs

Completed

• Conditions: Spondyloarthritis; Psoriatic Arthritis; Rheumatoid Arthritis
• Interventions: Drug: Biologic Agents

• Registration Number: NCT03496831
• Lead Sponsor: Simon Krabbe

Brief Summary

Background The risk for hospitalized infection (i.e. infection leading to hospitalization) in patients with inflammatory arthritis (rheumatoid arthritis (RA), psoriatic arthritis (PsA) or axial spondyloarthritis (axSpA) treated with biological drugs is known to be increased compared to the background population. In daily clinical practice, there is a need for a simple way to assess the absolute risk for hospitalized infection in individual patients based on easily available information such as age, diagnosis, functional status, comorbidities and medication. This risk estimate will be useful in clinical decision making e.g. when advising patients on whether or not to initiate biologic therapy or when advising patients on influenza or pneumococcal vaccination.

Objectives The objectives are 1) to assess the risk for hospitalized infection (infection leading to hospitalization) in patients with inflammatory arthritis during 12 months of follow-up after initiating treatment with their first biological drug (bDMARD) with the risk in the general population, and 2) to develop a simple, clinically useful algorithm that allows prediction of the risk of hospitalized infection in individual patients.

Methods Observational cohort study based on existing data in: The Danish Rheumatology Register (DANBIO), The Danish National Patient Register, The Danish National Prescription Register and The Danish Register of Causes of Death. All patients registered in DANBIO with RA, PsA or axSpA who initiated treatment with their first biological drug between January 1, 2006 and December 31, 2016 will be identified. Baseline predictors and outcomes (hospitalized infection or death) during 12 months of follow-up are obtained. Logistic regression analysis and 10-fold cross-validation will be used to develop and internally validate the prediction model.

Detailed Description

Not available

Study Timeline

• Study Start: 2006-01-01
• Primary Completion: 2017-12-31
• Study Completion: 2017-12-31
• Status Verified: 2018-04
• Study First Submitted: 2018-04-05
• Study First Submitted QC: 2018-04-05
• Study First Posted: 2018-04-12
• Last Update Submitted: 2018-04-12
• Last Update Posted: 2018-04-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 7500

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Psoriatic Arthritis	Biologic Agents	Registered in DANBIO with a diagnosis of M07.3 or M46.8+M07.2.
Rheumatoid Arthritis	Biologic Agents	Registered in DANBIO with a diagnosis of M05.9, M06.0 or M06.9.
Spondyloarthritis	Biologic Agents	Registered in DANBIO with a diagnosis of M45.9, M46.1, M46.8+M02.9, M46.8+M07.4, M46.8+M07.5 or M46.9.

Primary Outcome Measures

Name	Time	Method
Hospitalized infection or death	12 months of follow-up	Hospitalization caused by infection or death