for eMaxHealthRheumatoid Arthritis
Bristol-Myers Squibb Company announced the results of three post-hoc analyses from two Phase III pivotal trials that showed ORENCIA (abatacept) improved daily activity participation, such as work or household chores, physical and social-role independence and sleep quality in adult rheumatoid arthritis (RA) patients who have had an inadequate response to one or more disease-modifying anti-rheumatic drugs (DMARDs), such as methotrexate (MTX) or tumor necrosis factor (TNF) antagonists.
These data are from post-hoc analyses of two Phase III pivotal trials investigating ORENCIA: AIM (Abatacept in Inadequate responders to Methotrexate) and ATTAIN (Abatacept Trial in Treatment of Anti-TNF Inadequate Responders).
"The chronic nature of RA can have a significant impact on a person's health-related quality of life, including independence, ability to perform daily activities and sleep quality," said George Wells, M.Sc., Ph.D., Professor of the Department of Epidemiology and Community Medicine, University of Ottawa.
About the Data
Poster presentations of these analyses of the AIM (n=433 for ORENCIA plus MTX; n=219 for placebo plus MTX) and ATTAIN (n=258 for ORENCIA plus DMARDs; n=133 for placebo plus DMARDs) studies evaluating health-related quality of life improvement in daily activity participation, independence and sleep quality in RA patients treated with ORENCIA (abatacept) were presented last week at the ACR Annual Scientific Meeting in Boston, MA.
An analysis of the AIM and ATTAIN studies presented by Li, et al, looked at RA patients' ability to participate in daily usual activities using a validated activity participation questionnaire. Patients who were treated with ORENCIA were compared with those in the placebo group. This questionnaire was used to assess the number of days in the past 30 days that a patient was unable to perform his or her usual daily activities, defined as paid or unpaid work, household chores or personal care, due to RA. A change of four days in activity participation was deemed to be clinically meaningful.
The percent of patients demonstrating an ability to participate in daily activities in AIM was 61 percent for ORENCIA vs. 46 percent for placebo at one year, and in ATTAIN was 53 percent vs. 32 percent, respectively, at six months. The study found that activity gain was correlated to clinical aspects, physical function and health-related quality of life. In a multi-regression analysis, it was determined that key contributors to activity levels included joint counts, patient global assessment, fatigue, physical function and the physical domains as measured by the Short-Form (SF-36).
A separate analysis of the ATTAIN trial presented by Hassett, et al., examined the incidence of improvement in social role functioning and decreased need for help from others at six months for the ORENCIA group compared to placebo. This was assessed using a multidimensional scale for independence that was derived from validated measures (including the Health Assessment Questionnaire [HAQ], SF-36 and activity participation questionnaire) in which patient physical and social independence were evaluated. After a final analysis, this scale was constructed of two factors: socio-emotional role independence (including SF-36 role-physical, role-emotional, social functioning domains and days with activity limitation) and physical independence (including HAQ items on reach help, care help and ambulating help). Interviews with 20 RA patients confirmed the concept of measuring independence using a multidimensional scale that included these two factors.
Change in mean score on Factor 1 (socio-emotional role independence) was 0.921 for the ORENCIA group and 0.169 for the placebo group (p-value less than 0.0001). Change in mean score on Factor 2 (physical independence) was 0.499 for the ORENCIA group and 0.078 for the placebo group (p-value equals 0.0029). The study concluded that the multi-dimensional assessment of independence based on items from commonly used measurement tools (Disease Activity Score 28, Health Assessment Questionnaire Disability Index and SF-36) is viable.
An analysis of the AIM and ATTAIN studies, presented by Wells, et al, examined several different aspects of sleep in RA patients. Sleep quality was assessed using the validated Medical Outcomes Study sleep questionnaire (MOS- sleep). The treatment groups were compared on the seven derived MOS-sleep scales: awakened short of breath or with headache, snoring, sleep adequacy, sleep disturbance, drowsiness, and sleep problems Index I and Index II. Sleep problems Index I and II are summary scores based on the mean of several sleep- related issues, and a higher score indicates more severity in sleep problems.* In addition, the study compared sleep duration and optimal sleep based on the MOS-sleep module.
There was an 18 percent improvement in optimal sleep scores in the ORENCIA (abatacept) group versus -12 percent in the placebo group for the ATTAIN study (p-value less than 0.0001) at six months and a 16 percent improvement in optimal sleep scores in the ORENCIA group versus 5 percent in placebo group for the AIM study (p-value equals 0.0214) at 12 months. Sleep quantity was not significantly different. In the ATTAIN study, measurement of sleep adequacy was 9.0 in the ORENCIA group and 0.6 in the placebo group (p-value equals 0.0028), sleep disturbance was -11.3 in the ORENCIA group and -2.9 in the placebo group (p-value equals 0.0005), drowsiness was -10.5 in the ORENCIA group and -1.6 in the placebo group (p-value less than 0.0001) sleep problems Index I was -9.5 in the ORENCIA group and -1.4 in the placebo group (p-value less than 0.0001) and Index II was -9.8 in the ORENCIA group and -2.1 in the placebo group (p-value less than 0.0001). MOS-sleep scales measuring awakened short of breath or with headache and snoring were not significantly different in the ATTAIN group. In the AIM study, measurement of sleep disturbance in the ORENCIA group was -13.0 and -8.9 in the placebo group (p-value equals 0.0197), sleep problems Index I was -9.4 in the ORENCIA group and -6.7 in the placebo group (p-value equals 0.0476) and Index II was -10.4 in the ORENCIA group and -7.3 in the placebo group (p-value equals 0.0173). MOS-sleep scales measuring awakened short of breath or with headache, snoring, adequacy or drowsiness were not significantly different in the AIM group.ORENCIA
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