The US Food and Drug Administration today approved belimumab (Benlysta) as intravenous (IV) infusion for treatment of children aged 5 years and older with active, autoantibody-positive, systemic lupus erythematosus (SLE) who are receiving standard therapy.
Belimumab, a human monoclonal antibody, is a B-lymphocyte stimulator (BLyS)-specific inhibitor.
While belimumab is approved for use in adults with SLE, this is the first time that it has been approved for use in children with SLE.
In Pediatric Lupus Trial of Belimumab Plus Background Standard Therapy (PLUTO) of children with SLE, belimumab IV + standard therapy reduced the risk of the patients experiencing a severe flare by 62% and also increased the duration of experiencing the first severe flare, from 82 days to 160 days.
The safety and pharmacokinetic profiles of the drug in pediatric patients were consistent with those in adults with SLE.
Side effects: Nausea, diarrhea and fever
Warning and precautions: Mortality, serious infections, hypersensitivity and depression; it should not be co-administered with live vaccines. Patients also commonly experienced infusion reactions, so healthcare professionals are advised to pre-treat patients with an antihistamine.
(Source: US FDA)