Evaluation of TNFα Blockers Monotherapy in Early Rheumatoid Arthritis in France
Status:
Completed
Trial end date:
1969-12-31
Target enrollment:
Participant gender:
Summary
Aim: To describe 1) The use of TNF blockers monotherapy in early arthritis in daily clinical
practice in France 2) To evaluate symptomatic, structural efficacy, and retention rate over 5
years of TNF blockers monotherapy 3) To evaluate predictive factors for TNF blocker response
monotherapy Type of study: Observational cohort study using cross-section and longitudinal
data.
Description of the project methodology
- Patients: All patients in the ESPOIR cohort (multicentre French cohort study of early
RA).A sub-analysis will be conducted among patients satisfying the ACR-EULAR 2010
criteria.
- Data collected: Patient characteristics, Clinical data regarding RA and related
pathologies, Characteristics of treatments received The analysis will be conducted using
data collected at baseline, 6, 12, 18, 24, 36, 48, 60 months.
- Analyses:
1. Frequency of use of TNF blockers monotherapy: we will calculate the % of patients
initiating TNF blockers monotherapy (Kaplan-Meier method), and we will describe the
type of TNF blocker, the route of administration, the dosage, and the place of the
TNF blockers monotherapy in the treatment strategy during the first 5 years.
2. Identification of potential predictive factors for initiation of TNF blockers
monotherapy: a survival curve (Kaplan-Meier) will be performed. The baseline
characteristics of the patients with regard to the initiation of TNF blocker
monotherapy during the first 5 years of the disease will be compared by univariate
analysis and Log-rank test will be performed in all variables. A stepwise
multivariate analysis (Cox analysis) will be performed.
3. Therapeutical effect: we will calculate the retention rate over time, and will
compare the changes in different variables in the group of patients who have
received TNF blockers monotherapy matched (using a propensity score) to 1,2 or 3
patients who have received TNF blockers in combination with synthetic DMARDs. We
will assess and compare DAS28 and HAQ at short term (after at least 8 weeks of
treatment) and long term (last available visit) in groups. The structural efficacy
was evaluated by the radiographic progression at last available visit. We will
identically estimate the drug effect depending on the TNF blocker used, by
calculating the retention rate and comparing DAS28 at short term and long term.
4. Identification of predictive factors for TNF blocker monotherapy response: To
evaluate the impact of baseline demographics and disease conditions on the DAS28
and HAQ response during the first 5 years will be compared by univariate and
multivariate analysis.
Expected results:
Increase knowledge on the use of TNF blocker monotherapy, its efficacy and retention rate,
and on predictive factors for TNF blocker monotherapy response in early RA patients.