Phase 3 Trial Results Continue to Show the Efficacy of Orencia as a Treatment for Juvenile Idiopathic Arthritis

Orencia

Orencia (abatacept) is a treatment for juvenile idiopathic arthritis (JIA) that was approved for use in the U.S. for the pediatric patient population in 2008. In Japan, the therapy was approved for children in February of 2018. This therapy works by a different mechanism than any other approved treatment for rheumatoid arthritis.

Japan recently published results from a Phase 3 study investigating the effectiveness of this therapy in patients who didn’t respond to the recommended treatment, methotrexate.

The results from this study were published in Pediatric Rheumatology.

This Phase 3 clinical trial aimed to evaluate the efficacy, pharmacokinetics, distribution, and safety of Orencia in pediatric polyarticular JIA patients. 20 patients participated in the trial. All participants were between the ages of 5 and 16 and had no response to methotrexate or were found to be intolerant to methotrexate and/or another therapy.

Participants were given an injection of Orencia at the study’s initiation, at two weeks, and at four weeks. They then received an injection once every four weeks until the conclusion of the trial. The dosage of each injection was dependent on the patient’s weight.

Participants in this trial were allowed to simultaneously use methotrexate.

Results

The effectiveness of this therapy was evaluated by criteria outlined by the American College of Rheumatology (ACR). This includes 6 core JIA variables, including measures such as the number of active joints and inflammation markers. For what’s called ACR Pediatric 30, patients are considered to have a positive response to a therapy if they indicate at least 30% improvement in 3/6 of these measures. Additionally, they must have had no more than 30% worsening in any one of the measures.

ACR 50, 70, 90, require 50%, 70%, 90% improvements respectively. The worsening percentage remains the same in these criteria (no more than 30% in one measure).

At 12 weeks on the therapy Orencia, improvements were seen in the patients physical ability to do daily tasks such as eating, dressing, and walking.

2 patients discontinued the treatment following the 16-week mark.

Results at 16 weeks were as follows.

  • 90% of participants had a positive response when evaluated with ACR Pediatric 30
  • 75% of participants met ACR Pediatric 50 criteria
  • 70% of participants met ACR Pediatric 70 criteria
  • 35% of participants met ACR Pediatric 90 criteria.
  • 25% of participants reached inactive disease
  • 15% of participants reached disease remission
  • 45%  had minimal disease activity

Results after one year were as follows.

  • 88.9% of participants met ACR Pediatric 30 criteria
  • 88.9% of participants met ACR Pediatric 50 criteria
  • 83.3% of participants met ACR Pediatric 70 criteria
  • 66.7% of participants met ACR Pediatric 90 criteria
  • 44% of participants reached inactive disease
  • 50% of participants reached disease remission
  • 78% of participants had minimal disease activity

The IV administration of Orencia proved to be generally well-tolerated. There was only one severe AE reported with the vast majority of AEs being mild to moderate. There were no deaths, autoimmune conditions, or malignancies reported and no patient had to withdraw from the trial due to AEs.

Ultimately, this study confirmed that Orencia is an effective and safe option for patients who don’t tolerate methotrexate or other treatments.

You can read more about Orencia and this Japanese study here.


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