Update on belimumab for the management of systemic lupus erythematosus

Belimumab is a fully humanised mAb against B lymphocyte stimulator (B-LyS). It is the first biological drug to be licensed and approved by the US FDA and the European Medicines Evaluation Agency for use in combination with standard immunosuppressants in autoantibody-positive systemic lupus erythematosus (SLE). The clinical effectiveness and impact of this drug on lupus morbidity and mortality is evaluated in this review.

An overview of the efficacy and safety of belimumab based on 7-year longitudinal continuation study data from SLE patients enrolled in the Phase II double-blind, randomised, placebo-controlled, 52-week study of belimumab 1, 4 and 10 mg/kg doses and an overview of the open-label 24-week extension of belimumab plus standard immunosuppressant therapy. A review of the current belimumab clinical trials, the experience of belimumab in real-world settings and a description of the impact that belimumab has had on the healthcare quality of life of SLE patients.

The emerging clinical data have shed light on the areas in which belimumab is of greatest benefit and areas for further evaluation in clinical trials. It is anticipated that regular updates from ongoing trials of belimumab in SLE, practising physicians, data from the continuation arms of clinical trials and data from international biologics registries will have an influence on the role of belimumab in the management of SLE.