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)
Dr KK Aggarwal
Padma Shri Awardee
President Elect Confederation of
Medical Associations in Asia and Oceania
(CMAAO)
Group Editor-in-Chief IJCP Publications
President Heart Care Foundation of
India
Past National President
IMA
