Evaluation of Tumour Necrosis Factor Alpha (TNFα) Blockers 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 in early arthritis in daily clinical practice in
      France 2) To evaluate symptomatic, structural efficacy, and retention rate over 5 years 3) To
      evaluate predictive factors for TNF blocker response 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 ACREULAR 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: the % of patients initiating TNF blockers will be
                calculated (Kaplan-Meier method), and the type of TNF blocker will be described,
                the route of administration, the dosage, the association with other DMARDs and the
                place of the TNF blockers in the treatment strategy during the first 5 years.

             2. Implementation of EULAR recommendations: the percentage of patients that initiate
                TNF blockers meeting the EULAR criteria for initiation will be estimated, and the
                concordance coefficient Kappa with regard to such fulfilment and the initiation of
                TNF blockers will be calculated, and disease severity outcome measures will be
                compared depending on the fulfilment or not.

             3. Identification of potential predictive factors for initiation of TNF blockers: a
                survival curve (Kaplan-Meier) will be performed. The baseline characteristics of
                the patients with regard to the initiation of TNF blocker 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.

             4. Therapeutical effect:the retention rate over time will be calculated, the changes
                in different variables will be compared in the group of patients who have received
                TNF blockers matched (using a propensity score) to 1,2 or 3 patients who have not.
                The DAS28 and HAQ will be assessed and compared at the 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.The
                drug effect will be identically estimated depending on the TNF blocker used, by
                calculating the retention rate and comparing DAS28 at short term and long term.

           6) Identification of predictive factors for TNF blocker 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 optimal use of TNF blocker and on predictive factors for TNF
      blocker response in early RA patients.
    


Intervention name(s): TNF alpha blockers
Intervention type(s): Drug
Intervention MeSH terms: Adrenergic alpha-Antagonists
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        - Patients: All patients in the ESPOIR cohort (multicentre French cohort study of early
        RA).A sub-analysis will be conducted among patients satisfying the ACREULAR 2010 criteria.