FDA approves new administration option for Orencia in polyarticular Juvenile Idiopathic Arthritis

“The data supporting this new FDA approved prefilled syringe provide a scientific basis for the dosing, efficacy and safety of subcutaneous abatacept in JIA and add to the growing body of clinical evidence for patients 2 years of age and older living with this difficult autoimmune disease,” said Daniel J. Lovell, M.D., M.P.H., Joseph E. Levinson Endowed Chair of Pediatric Rheumatology and professor of Pediatrics, University of Cincinnati Medical Center. “Importantly, subcutaneous abatacept also provides physicians a new administration option to offer their patients.”

JIA is the most common type of arthritis in children and a condition that makes it difficult to do everyday things, and may eventually result in disability. Orencia SC is a prescription medicine that is indicated for reducing signs and symptoms in patients 2 years of age and older with moderately to severely active JIA. 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.

Orencia SC should be initiated without an IV loading dose and administered once-weekly using weight-tiered dosing: 50 mg/0.4 mL syringe (for patients 10 to <25 kg), 87.5 mg/0.7 mL syringe (for patients 25 to <50 kg) and 125 mg/mL syringe (for patients =50 kg). Dosage is to be determined by a physician. Patients or caregivers should receive training on the right way to prepare and inject Orencia.

It is not known if Orencia SC is safe and effective in children under 2 years of age. Intravenous dosing has not been studied in patients younger than 6 years of age. The safety and efficacy of Orencia ClickJect TM Autoinjector for subcutaneous injection has not been studied in patients under 18 years of age.

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.

In general, the adverse events observed in pediatric patients with Juvenile Idiopathic Arthritis were similar in frequency and type to those seen in adult patients.

In the intravenous Study JIA-1, the overall frequency of adverse events in the 4-month, lead-in, open-label period of the study was 70%; infections occurred at a frequency of 36%. The most common infections were upper respiratory tract infection and nasopharyngitis. The infections resolved without sequelae, and the types of infections were consistent with those commonly seen in outpatient pediatric populations. Other events that occurred at a prevalence of at least 5% were headache, nausea, diarrhea, cough, pyrexia, and abdominal pain. A total of 6 serious adverse events (acute lymphocytic leukemia, ovarian cyst, varicella infection, disease flare, and joint wear) were reported during the initial 4 months of treatment with Orencia IV. One case of a hypersensitivity reaction (0.5%) was reported. During Periods A, B, and C of Study JIA-1, acute infusion-related reactions occurred at a frequency of 4%, 2%, and 3%, respectively, and were consistent with the types of events reported in adults. Upon continued treatment in the open-label extension period, the types of adverse events were similar in frequency and type to those seen in adult patients, except for a single patient diagnosed with multiple sclerosis while on open-label treatment.

The safety experience and immunogenicity for Orencia administered subcutaneously in Study JIA-2 were consistent with the intravenous Study JIA-1. There were no reported cases of hypersensitivity reactions and local injection-site reactions occurred at a frequency of 4.4%.

“Juvenile Idiopathic Arthritis can cause pain, stiffness and swelling that may make it difficult for children to do everyday things like playing with friends or riding a bike. Understandably, the condition can impact the entire family,”said Brian J. Gavin, Vice President, Orencia Development Lead at Bristol-Myers Squibb. “We’re proud to be able to provide a new subcutaneous administration option1 for Orencia, a proven choice for patients with JIA, as part of our commitment to advancing immunoscience research to address unmet needs and supporting JIA patients and their families.”

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