Evaluation of TNFα Blockers Monotherapy in Early Rheumatoid Arthritis in France
Condition: Rheumatoid Arthritis
MeSH terms: Arthritis; Arthritis, Rheumatoid
Study type: Observational

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.
    


Intervention name(s): TNF blockers monotherapy
Intervention type(s): Drug
Intervention MeSH terms: Tumor Necrosis Factor Inhibitors
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        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.