Subcutaneous abatacept is now available for patients aged 2 years or older with moderately to severely active polyarticular juvenile idiopathic arthritis, according to a company press release. The new prefilled syringe allows for the treatment to be administered at home.
“The data supporting this new, FDA-approved prefilled syringe provide a scientific basis for the dosing, efficacy and safety of subcutaneous abatacept in [juvenile idiopathic arthritis] JIA and add to the growing body of clinical evidence for patients 2 years of age and older living with this difficult autoimmune disease,” Daniel J. Lovell, MD, MPH, from the University of Cincinnati Medical Center, said in the release.
According to the release, abatacept (Orencia, Bristol-Myers Squib) may be used as monotherapy or with methotrexate, but should not be used with tumor necrosis factor inhibitors or other biologic rheumatoid arthritis therapy. Subcutaneous abatacept is administered once per week as 50 mg/0.4 mL for patients between 10 kg and 25 kg, 87.5 mg/0.7mL for patients between 25 kg and 50 kg and 125 mg/mL syringe for patients who weigh at least 50 kg. The Orencia ClickJect autoinjector has not been studied in children.
Data for the subcutaneous indication was based on a 4-month phase 3 trial of 205 patients with a 20-month extension period. The safety and efficacy profile of subcutaneous abatacept matched the intravenous version.
“Importantly, subcutaneous abatacept also provides physicians a new administration option to offer their patients,” Lovell said.