ORENCIA Improves Health-Related Quality of Life, Pain and Sleep Quality in Children With Juvenile Idiopathic Arthritis
By Lauren Castillo at 28 October, 2008, 7:05 am
Bristol-Myers Squibb Company announced at the American College of Rheumatology (ACR) Annual Scientific Meeting in San Francisco results from a 10-month study which showed that ORENCIA (abatacept), compared to placebo, significantly improved multiple aspects of health-related quality of life (HRQoL): physical and psychosocial well being, pain and sleep quality in juvenile idiopathic arthritis (JIA) patients between the ages 6 and 17 years. These improvements with ORENCIA were maintained throughout the 10-month study period, during which the first four months included an open-label lead-in period and the last six months comprised a randomized, double-blind, placebo-controlled study.
These results were part of a study looking at the safety and efficacy of ORENCIA in children with JIA who had failed on previous treatments such as methotrexate (MTX) or biologics. Data from this study was used to obtain U.S. Food and Drug Administration approval of ORENCIA on April 8, 2008, for reducing the signs and symptoms in children and adolescents 6 years of age and older with moderate-to-severe polyarticular JIA. In children and adolescents, ORENCIA may be used alone or with MTX.
“Health-related quality of life, or HRQoL, in children with JIA can be significantly impaired due to pain, joint damage and inflammation,” said the study’s lead investigator, Daniel Lovell, M.D., M.P.H., director, Division of Rheumatology, Cincinnati Children’s Hospital Medical Center. “Therefore, successful treatment of JIA should positively impact patient-centered outcomes in HRQoL, daily functioning and psychosocial well being.”
Study Design and Findings
In this 10-month, two-phase study, 190 children with JIA between the ages of 6 and 17 years were enrolled. In the first phase of the study (Period A), which was an open-label lead-in period, all patients were treated with ORENCIA 10 mg/kg intravenously at Day 1, 15, 29, and approximately every 28 days thereafter for four months. In Period B, patients who completed Period A and achieved an American College of Rheumatology Pediatric (ACR Pedi) 30 percent response—defined as 30 percent or more improvement in at least three of the six JIA core set variables and not more than one JIA core variable showing 30 percent or more worsening—were then randomized to a double-blind withdrawal phase with ORENCIA (abatacept) or placebo for up to six months (ORENCIA n=60; placebo n=62).
There were three validated measures in this study used to assess HRQoL. The first was the Child Health Questionnaire (CHQ), which contains 15 health domains covering a child’s physical and psychosocial well being and the impact of JIA on parents and family. The second was sleep quality, as measured by the Children’s Sleep Habits Questionnaire (CSHQ), which has eight domains that measure the most common sleep problems in children and adolescents: bedtime resistance, sleep onset delay, sleep duration, sleep anxiety, night walkings, parasomnias, sleep disordered breathing and daytime sleepiness. The third measure was pain, assessed by a Visual Analog Scale (VAS) Score of 0 to 100 mm. The VAS Score for pain is a global quality-of-life indicator in which the patient identifies along a continuum the amount of pain they are feeling. For these measures, mean change from baseline in each period was calculated and compared between the treatment groups in Period B and the change over time.
At the conclusion of Period A (four months), treatment with ORENCIA demonstrated significant improvements on all patient reported measures. Improvements in CHQ scores were significant in 14 out of 15 health domains measured (as measured by 95 percent confidence intervals). The greatest CHQ improvements were seen in the physical domain, which consists of physical functioning, bodily pain, role-physical and general health. With ORENCIA, pain was significantly reduced by Day 15 of Period A (-5.9 points; as measured by 95 percent confidence intervals) and was further reduced by the end of the period (-18.7 points; as measured by 95 percent confidence intervals). On the CSHQ, the sleep problem index decreased significantly by 1.86 points (p-value less than 0.05).
At the end of Period B, most ORENCIA patients maintained or continued these HRQoL improvements in 10 of the 15 CHQ health domains, while placebo patients generally experienced declining HRQoL (in 13 of 15 CHQ health domains), increased pain (+8.4 points; as measured by 95 percent confidence intervals) and sleep problems (+1.2 points; as measured by 95 percent confidence intervals).
Additional data from this study will also be presented at the ACR Annual Scientific Meeting by Tracy Li, Ph.D, director, Global Health Outcomes, Bristol-Myers Squibb, on Wednesday, October 29, at 8 a.m. (Pacific Time). Dr. Li’s presentation, which will look at the real-life impact of ORENCIA (abatacept) on JIA patients and their parents, is entitled “Reduction in Missed School Days and Improvements in Parent Activity Participation in Children with Juvenile Idiopathic Arthritis Treated with Abatacept.”
No comments yet.