Lasting Long-Term Benefits for Abatacept in JIA

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Many patients with juvenile idiopathic arthritis (JIA) must remain on biologics for years. Now an international study shows that long-term treatment with abatacept (Orencia) is safe and effective in JIA -- improvements in patient-reported quality of life have been sustained for up to 7 years.

These results come from the long-term, open-label extension of a phase III study of IV abatacept conducted among patients for whom previous treatment with DMARDs proved inadequate.

Most of the 153 patients achieved 30% or greater improvements in JIA American College of Rheumatology (JIA ACR30, 50, 70, 90) responses, and a third had clinically inactive disease going into the extension. These benefits were maintained.

The patients, a majority females ages 5 to 17 with an average disease duration of 4 years before the trial, also had improvements in pain levels. Almost 20% were free of pain and had better sleep quality and improved participation in daily activities, including school.

Abatacept was associated with clinical improvements during the 4-month, open-label lead-in period. A 6-month, double-blind withdrawal preceeded the long-term extension.

While a large proportion of the study group withdrew from the LTE (n=84), subsequent analysis adjusting for this factor show the numbers of those achieving a JIA ACR 90 response (21% to 27%) or clinically inactive disease status (16% to 22%) remained relatively stable during the extension.

The investigators point out that more than 50% of those who discontinued did so for reasons other than lack of efficacy or adverse events; similar to discontinuation rates for other biologicals such as infliximab (Remicade) and etanercept Enbrel) in JIA.

Adverse events/serious adverse events--mostly respiratory infections--occurred in 20% of the group.

The patients, enrolled at pediatric rheumatology centers across Europe, Latin America, and the US, were also allowed corticosteroids, methotrexate, and non-biologic DMARDs during the trial.

The study is important, the researchers write, because “long-term follow-up data for the treatment of JIA with other available biologic therapies are scarce, with the exception of etanercept, for which clinical efficacy and safety have been demonstrated for up to 8 years.”

References:

Lovell DJ, Ruperto N, Mouy R, et al. Long-term safety, efficacy, and quality of life with intravenous abatacept in juvenile idiopathic arthritis: up to 7 years of treatment. Arthritis & Rheumatology. 2015. Accepted Article. Online June 26, 2015.