Retrospective Administrative Claims Database Evaluation of Utilization of Belimumab in United States Managed Care Settings

Trial description: Belimumab is the first in a new class of drugs called B lymphocyte stimulator (BLyS)-specific inhibitors. It was approved in March 2011 for the treatment of moderate to severe systemic lupus erythematosus (SLE) in patients with active, autoantibody-positive SLE. While belimumab has demonstrated efficacy in randomized-controlled trials, little is known about how this new medication is being used in clinical practice.The objectives of this study are to describe the clinical and demographic characteristics of subjects receiving belimumab treatment, characterize the treatment history prior to initiation with belimumab for patients with SLE, describe the characteristics of physicians who prescribe belimumab, describe the patterns of belimumab use following initiation (e.g., duration of therapy, compliance with administration schedule), describe the utilization of standard therapies for SLE following initiation of belimumab and describe all-cause resource use for patients who have a specified length of pre/post eligibility in the pre- and post- period from the first medical claim for belimumab within the intake period. The results will inform hypothesis generation and will be useful for informing sample-size requirements for future comparative analyses.The data source for this retrospective, observational cohort study is the HealthCore Integrated Research Database (HIRD). This database includes claims data from various types of insurance plan designs, such as health maintenance, point of service, preferred provider organization, and indemnity plans from a commercially-insured population in the United States (US).