Abstract

To assess demographic and disease characteristics of rheumatoid arthritis (RA) patients starting treatment with biologic disease-modifying anti-rheumatic drugs (DMARDs) in observational studies. Systematic review of published observational studies in adult patients with RA treated with one of three biologic DMARDs (etanercept, rituximab, tocilizumab). We identified eligible studies through electronic searches of the MEDLINE and EMBASE databases. Two reviewers screened the articles independently. We extracted study characteristics such as location and calendar period, demographics of study populations, dose, frequency and concomitant therapies, and baseline characteristics such as disease duration, disease activity and lab measurements. 106 papers met our inclusion criteria. Studies were published between 2003 and 2015 and mostly from Europe; 39 included patients starting etanercept, 36 included patients starting rituximab and 32 patients starting tocilizumab. Mean age ranged between 42.9 and 63.3 years, 78.2% were female. The drugs were given in combination with methotrexate and/or other traditional DMARDs in over two thirds of the studies. Mean disease duration varied between 4 and 17.5 years, baseline disease activity 28 scores between 4.3 and 7.0, and baseline health assessment questionnaire values between 1 and 2.9. The mean percentage of rheumatoid-factor positive patients was 76.4%. Reporting of comorbidities and smoking status was generally poor, with only few studies providing detailed data. This systematic review of data from observational studies and clinical databases indicates that the characteristics of RA patients starting biological DMARDs outside clinical trials in the real world varied widely. These observational data will now be compared with clinical trial data but it seems likely that some patient groups were not well represented in the trials.

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