Friday, 13 Jul 2018

You are here

FDA Approves Abatacept for Pediatric Use

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%.

 

Disclosures: 
The author has no conflicts of interest to disclose related to this subject

Add new comment

More Like This

The Diverse Fate of Seronegative Rheumatoid Arthritis

A Finnish Rheumatology Center followed 435 early, seronegative rheumatoid arthritis (RA) patients for 10-years and found that only 3% became erosive or seropositive RA. They also found that 32% could not be further reclassified, and that the remaining 65% evolve into another diagnosis, led by polymyalgia rheumatica (16%), psoriatic arthritis (11%), spondyloarthritis (9%), and osteoarthritis (10%).  

Does RA Have a Prodrome?

A pattern of increased primary care visits and joint complaints during the 2 years before rheumatoid arthritis (RA) was diagnosed were predictive of the diagnosis, a British case-control study found.

Can DMARDs Delay Rheumatoid Onset?

Preclinical rheumatoid arthritis (RA) is a hot new area wherein at risk individuals (seropositive, first degree relatives of RA patients, etc.) are being studied to assess the triggers that lead to progression to RA or whether therapies can be used to avert the onset of RA.

Seronegative and Seropositive Rheumatoids Respond Equally Well

A cohort study of 241 DMARD-naive rheumatoid arthritis (RA) patients, meeting either 1987 ACR or the 2010 ACR/EULAR  classification criteria for RA, compared the baseline status and long term outcomes of seronegative (SNRA) and seropositive (SPRA).

We Measure What we do in RA, But so What?

We are supposed to treat to a target (T2T) in RA. In other words, measure many components of the disease and its activity and calculate a score and if the patient is not in remission (or a low state if remission is not achievable) we are to make a treatment change.