“This demonstrates real-life tangible benefits to JIA patients as a result of clinical and quality of life improvements.”—Tracy Li, PhD
“This demonstrates real-life tangible benefits to JIA patients as a result of clinical and quality of life improvements,” report the researchers who were led by Tracy Li, PhD, director of global health outcomes at the Bristol-Myers Squibb Company in Princeton, New Jersey, the drug’s manufacturer.School days missed dropped from 4.1/month to <1/month
In the randomized, double-blind, placebo-controlled trial, 190 JIA patients with a mean age of 12.4 received monthly infusions of 10mg/kg of abatacept for 4 months in an open-label lead-in period (Period A). The 123 patients who achieved an American College of Rheumatology Pediatric 30 were then randomized 1:1 to receive abatacept or placebo for 6 months in a double-blind withdrawal period (Period B).
Researchers tracked activity participation for the child (ie, the number of missed school days in the past month due to JIA) and the parents (ie, the number of missed usual work/nonwork activities days due to the child's JIA and the number of days paid for childcare in order to engage in usual activities in the past month), along with clinical and quality of life (QOL) parameters.
During baseline period A, children missed an average of 4.1 days of school a month; parents missed 3.5 days of usual activity and had to pay for childcare for 1.4 days per month. By month 4 of the lead-in period, patients, including those who had not responded to the therapy, reported an average 1.69 day reduction in days out of school that month, while parents reported a 1.92 day reduction in missed activities and a 1.18 day reduction in paid childcare.
In Period B, children randomized to continue abatacept gained another 1.5 days/month of school per month, and on average missed less than 1 day per month. Children randomized to placebo missed 0.56 days more of school each month. Parents of abatacept patients maintained their gains in usual activity from Period A, while parents of placebo patients had 1.1 days/month of missed activities. The improvements in activity were consistent with clinical responses and quality of life improvements, the study showed.
“In this trial, we wanted to look at the real-life impact of abatacept on JIA patients and their parents," Dr. Li explained. "Patients with moderate to severe disease treated with abatacept missed less school days compared to the beginning of the study. Also, parents missed less time from work and other activities."
Translating research into practice
“The take-home message is that aggressive therapy to get these diseases under control as quickly as possible is the right way to go,” said Kathleen A. Haines, MD, section chief of pediatric immunology at Hackensack University Medical Center, in New Jersey “Missed school is a significant problem, particularly for the polyarticulars and systemics.”
When asked if aggressive therapy with other agents would produce similar benefits, Dr, Haines said that while this has not been studied,” I think any good agent that gets the arthritis under control would have the same effect.”
Reference
1. Li T, Lovell DJ, Ruperto N, et al. Reduction in missed school days and improvement in parent activity participation in children with juvenile idiopathic arthritis treated with abatacept. Presented at: American College of Rheumatology 2008 Annual Scientific Meeting; October 24-29, 2008; San Francisco, Calif. Presentation 2019.