An international study shows that long-term treatment with abatacept is safe and effective in juvenile idiopathic arthritis.
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.”
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.