Children with juvenile rheumatoid arthritis may miss fewer days of school when treated with abatacept, according to research presented this week at the American College of Rheumatology Annual Scientific Meeting in San Francisco, Calif.

There are several different types of juvenile arthritis. The most common form is juvenile rheumatoid arthritis, also known as juvenile idiopathic arthritis, or JIA. There are several different types of JIA. All cause joint inflammation and begin before the age of 16 years, but otherwise are often associated with distinct symptoms and complications and may require different approaches to treatment.

Chronic pain and physical disability from JIA limit children from participating in daily activities and often cause them to miss school. In addition to the struggle of a child missing several days of school each month due to JIA, parents often miss work and other important activities to care for their children when they are out of school. This can have a great impact on the overall well-being of a family.

In a recent controlled study of abatacept compared to placebo, researchers looked at the number of school days each patient missed in a month and the number of usual work and non-work activity days parents experienced in a month due to their children’s JIA. Finally, researchers looked at the number of days parents had to pay for childcare in order to engage in regular activities in a month and the overall quality of life experienced by both patients and parents during this time.

Researchers followed 190 JIA patients to determine whether activity participation changed in both the patients and their parents following abatacept (Orencia) treatment. Patients received monthly infusions of abatacept (at 10 milligrams per kilograms) for four months during an open-label, lead-in period.

At the beginning of the study, patients missed an average of 4.1 days of school per month. Their parents missed an average of 3.5 days of usual activity, while paying for 1.4 days of childcare per month.

During the four-month lead-in period of the study, researchers noticed a gradual reduction of missed activity days for both patients and their parents. By month four 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 days of missed activities and a 1.18 day reduction in paid childcare.

After this lead-in period, 123 patients, whose average age was 12.4 years, and who had improved to an ACR Pedi 30 score (a composite measure of symptoms and well being) were then equally divided into two groups to either continue receiving abatacept, or begin receiving placebo during a double-blind withdrawal period.

Those patients who continued receiving abatacept reduced their time out of school by another 1.52 days each month—missing less than one day on average—while those placed on placebo actually increased their number of days out of school by 0.56.

Parents of children who remained on abatacept continued to reduce their days of missed usual activity by 0.20 days, in comparison to parents of patients on placebo who reported a 1.11 day increase. However, each set of parents reported the same continued reduction in days of paid childcare.

These improvements in activity were consistent clinical and quality-of-life improvements, and demonstrate the real-life, tangible benefits of this treatment in the lives of children with JIA.

“In this trial, we wanted to look at the real-life impact of abatacept on JIA patients and their parents,” explained Tracy Li, PhD, director of global health outcomes; Bristol-Myers Squibb Company, and the lead author of the study. “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.”

Patients should talk to their rheumatologists to determine their best course of treatment.

The ACR is an organization of and for physicians, health professionals, and scientists that advances rheumatology through programs of education, research, advocacy and practice support that foster excellence in the care of people with or at risk for arthritis and rheumatic and musculoskeletal diseases. For more information on the ACR’s annual meeting, see http://www.rheumatology.org/annual.

Editor’s Notes: Dr. Li will present this research during the ACR Annual Scientific Meeting at the Moscone Center from 8:00 – 8:15AM ON Wednesday, October 29, in Room 204. Dr. Li will be available for media questions and briefing at 1:30PM on Monday, October 27 in the on-site press conference room, 114.

Presentation Number: 2019

Reduction in Missed School Days and Improvement in Parent Activity Participation in Children with Juvenile Idiopathic Arthritis Treated with Abatacept

Tracy Li1, DJ Lovell2, Nicolino Ruperto3, Leonard Sigal1, Alan Block1, EH Giannini2, Allison Covucci1, Alberto Martini3. 1Bristol-Myers Squibb, Princeton, NJ; 2PRCSG, Cincinnati, OH; 3PRINTO, Genoa, Italy

Background: Chronic pain and physical disability from juvenile idiopathic arthritis (JIA) limits patients’ capacity to participate in usual daily activities, and often cause children to miss school and parents to miss work. Effective treatment that improves physical function, reduces pain, and prevents flares may allow patients to regain their normal activities.

Purpose: To investigate the change in activity participation in both children with JIA and their parents, following abatacept treatment.

Methods: Data were from a randomized, double-blind, placebo-controlled trial. 190 JIA patients received monthly infusions of abatacept 10mg/kg for 4 months in an open-label lead-in period (Period A). ACR Pedi 30 responders (n=123) were then randomized 1:1 to receive abatacept or placebo for 6 months in a double-blind withdrawal period (Period B). Activity participation for the child (the number of missed school days in the past month due to JIA) and the parents (the number of missed usual work/non-work 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) were assessed, along with clinical and quality of life (QOL) parameters. Mean change from baseline in each period was analyzed, and the two treatment groups were compared.

Results: The mean age of the patients was 12.4 years. At Period A baseline, 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. During period A, there was a gradual reduction of missed activity days for both children and parents (Table). In Period B, children randomized to continue abatacept reduced another 1.5 days/month of missed school, compared to an increase of 0.56 days/month from placebo. Parents of abatacept patients maintained their gains in usual activity from Period A, while parents of placebo patients occurred 1.1 days/month of missed activities. The improvements in activity were consistent with clinical responses and QOL improvements observed.

Conclusion: Abatacept treatment improved patient’s ability to participate in daily activities allowing children to miss less school and parents get back to usual daily activities. This demonstrates real-life tangible benefits to JIA patients as a result of clinical and QOL improvements.

Disclosure Block: T. Li, Bristol-Myers Squibb, 3; D. Lovell, Abbott, 5; Amgen, 5; Bristol-Myers Squibb, 5; Centocor, 5; Hoffmann-La Roche, 5; Novartis, 5; Pfizer, 5; Regeneron, 5; Xoma, 5; Editoral Board, Clinical and Experimental Rheumatology; Associate Editor, Arthritis Care and Research, 9; N. Ruperto, Bristol-Myers Squibb, 2; L. Sigal, Bristol-Myers Squibb, 3; A. Block, Bristol-Myers Squibb, 3; E. Giannini, Bristol-Myers Squibb, 5; A. Covucci, Bristol-Myers Squibb, 3; A. Martini, Bristol-Myers Squibb, 2.

Source: American College of Rheumatology (ACR)