FDA Approves Abatacept for Pediatric Use Save

Subcutaneous (SC) abatacept (Orencia) is now available for use in patients 2 years of age and older with moderately to severely active polyarticular Juvenile Idiopathic (JIA) according to Bristol-Myers Squibb.  Orencia was previously approved for use in adults with rheumatoid arthritis (RA) and was FDA approved for pediatric use in March 2017.

The drug is available as a prefilled syringe or for IV administration and, in children, should be dosed according to weight.

For intravenous use, pediatric patients weighing less than 75 kg receive 10 mg/kg intravenously based on the patient’s body weight. Pediatric patients weighing 75 kg or more should be administered adult dosing, not to exceed a maximum dose of 1000 mg. Intravenous  Dosing has not been studied in patients younger than 6 years of age.  

Weight-based subcutaneous weekly doses for JIA patients should be either 50 mg  mg/0.4 mL syringe (for 10-25 kg); 87.5 mgmg/0.7 mL syring (25-50 kg) or 125 mg (>50 kg). The safety and efficacy of Orencia ClickJect TM Autoinjector for subcutaneous injection has not been studied in patients under 18 years of age.

Orencia may be used as monotherapy or concomitantly with methotrexate (MTX). Orencia should not be administered concomitantly with TNF antagonists, and is not recommended for use concomitantly with other biologic RA therapy, such as anakinra.

In Study JIA-2, an open-label, phase 3 study with a 4-month short-term period (n=205) and a 20 month open-label extension period, the primary objective was evaluation of PK in order to support the extrapolation of efficacy based on exposure to Orencia supported by descriptive efficacy. Pharmacokinetics, safety and efficacy of SC Orencia were assessed in patients ages 2 to 17 years with JIA and an inadequate response to at least one nonbiologic or biologic DMARD. At study entry, 80% of patients were receiving methotrexate and remained on a stable dose of methotrexate. JIA ACR 30, 50, and 70 response rates at 4 months were 81%, 71% and 53%, respectively and were observed to be consistent with the results from the IV study, JIA-1.

Abatacepts safety profile in pediatric JIA patients is similar to that seen in adult patients. There were no reported cases of hypersensitivity reactions and local injection-site reactions occurred at a frequency of 4.4%.