Medication Monitor

Generic Name (Trade Name—Company)
April 30, 2019


FDA approves first treatment for pediatric patients with lupus

FDA approved belimumab as an I.V. infusion for treatment of children with systemic lupus erythematosus (SLE). This is the first FDA approval of a treatment for pediatric patients with SLE. Belimumab has been approved for use in adult patients since 2011.

While childhood-onset SLE is rare, when diagnosed, it is generally more active in children and adolescents than adult patients, particularly in how it affects organs such as the kidneys and central nervous system. As a result of the disease starting early in life, pediatric patients with SLE are at a higher risk for developing increased organ damage and complications from the disease as well as adverse events from the life-long treatments usually required.

Efficacy belimumab I.V. for treatment of SLE in pediatric patients was studied over 52 weeks in 93 pediatric patients with SLE. The proportion of pediatric patients achieving the composite primary endpoint, the SLE response index (SRI-4), was higher in pediatric patients receiving belimumab I.V. plus standard therapy compared with placebo plus standard therapy. Pediatric patients who received belimumab I.V. plus standard therapy also had a lower risk of experiencing a severe flare, as well as longer duration of time until a severe flare (160 d vs. 82 d). The drug’s safety and pharmacokinetic profiles in pediatric patients were consistent with those in adults with SLE.

Belimumab I.V.’s doctor and patient information includes a warning for mortality, serious infections, hypersensitivity, and depression, based on data from the clinical studies in adults with SLE. The drug should not be administered with live vaccines. The manufacturer is required to provide a Medication Guide to inform patients of the risks associated with the drug.

The most common adverse effects include nausea, diarrhea, and fever. Patients also commonly experienced infusion reactions, so health professionals are advised to pretreat patients with an antihistamine.