PARIS, November 9 /PRNewswire/ --
-- Data to be Presented at Upcoming American College of Rheumatology Annual Meeting
Bristol-Myers Squibb Company (NYSE: BMY) today announced that two-year data from three Phase III pivotal trials demonstrate the long-term efficacy of abatacept in adult patients with moderate to severe rheumatoid arthritis (RA) who have had an inadequate response to one or more disease-modifying anti-rheumatic drugs (DMARDs) such as methotrexate and TNF antagonists. The data also demonstrate that abatacept provided clinically meaningful improvements in multiple aspects of health-related quality of life and physical function, sustained improvements in pain and had a consistent safety and tolerability profile through two years of treatment.[1],[2] These data will be presented at the upcoming 2006 American College of Rheumatology (ACR) Annual Scientific Meeting.
The findings are from analyses of the ongoing open-label, long-term extension component of Phase III pivotal trials investigating abatacept, including the AIM (Abatacept in Inadequate responders to Methotrexate), ATTAIN (Abatacept Trial in Treatment of Anti-TNF Inadequate Responders) and ASSURE (Abatacept Study of Safety in Use with other Rheumatoid Arthritis Therapies) trials.
"These data are encouraging and add to the body of evidence demonstrating that abatacept is an effective option providing durable response for patients who have not benefited from previous treatment with disease-modifying anti-rheumatic drugs," said Mark Genovese, M.D., associate professor of medicine at Stanford University School of Medicine, Palo Alto, CA, who is presenting data from ATTAIN at the ACR congress. "Given that rheumatoid arthritis is a chronic disease, long-term data such as these are important and offer physicians additional insight to help them make the most appropriate treatment decisions for their patients."
Details of Data to be Presented
Two separate poster presentations evaluating two-year, open-label, long-term extension data from the AIM (Abatacept in Inadequate responders to Methotrexate) and ATTAIN (Abatacept Trial in Treatment of Anti-TNF Inadequate Responders) trials will be presented at the ACR Annual Scientific Meeting in Washington, DC. These include Dougados et al, to be presented on Sunday, November 12, Poster No. 502, and Luggen et al, to be presented on Monday, November 13, Poster No. 980.
Results from the study presented by Dougados showed a sustained improvement in pain for both the AIM and ATTAIN populations receiving abatacept through two years, for the intent-to-treat (ITT) population. The mean change in baseline at one year was -35.5 for the abatacept arm of the AIM group (n=376) and -24.1 for the placebo group (n=160). At two years, the mean change in baseline for abatacept patients was -37.7. The mean change in baseline at six months was -30.8 for the abatacept arm of the ATTAIN group (n=217) and -10.2 for the placebo group (n=99). At two years, the mean change in baseline for abatacept patients was -37.2.
The study presented by Luggen, showed sustained improvements in physical function for both the AIM and ATTAIN populations through two years as assessed using the Health Assessment Questionnaire Disability Index (HAQ-DI). HAQ-DI was assessed for the intent-to-treat population (ITT), using a last observation carried forward (LOCF) analysis. Responders were defined as those achieving a change of greater than or equal to 0.3 HAQ-DI units from baseline. In the AIM group, 71.8 percent were HAQ responders at year one and 66.8 percent were HAQ responders at year two. In the ATTAIN group, 54.4 percent were HAQ responders at six months and 47.9 percent were HAQ responders at two years.
A separate analysis of the two-year ATTAIN trial (Genovese, et al) will be presented on Sunday, November 12, 2006, Poster No. 498. Of the 258 patients originally treated with ORENCIA during the double-blind phase, 218 entered an open-label, long-term extension (LTE), with 156 of these completing 2 years of the study.[3] Data, analyzed using an LOCF analysis (all patients who entered the LTE, with discontinued patients considered as non-responders), demonstrated sustained efficacy over time in the ATTAIN population. At six months, ACR 20, 50 and 70 scores were achieved in 59.4 percent, 23.5 percent and 11.5 percent, respectively, in those treated with ORENCIA. At two years, ACR 20, 50 and 70 scores were achieved in 56.2 percent, 33.2 percent and 16.1 percent, respectively, of those completing two years of treatment with ORENCIA(R) (abatacept).
Two-year data from ASSURE (Abatacept Study of Safety in Use with other Rheumatoid Arthritis Therapies; Weinblatt, et al) will be presented on Sunday, November 12, 2006, Poster No. 509. According to the results, abatacept plus background non-biologic therapies demonstrated a consistent safety profile through two years.[4] At year one, the incidence rate for serious adverse events (SAEs) per 100 patient years (n=957 patient years) was 18.8 and 491.4 for adverse events (AEs). At year two, the incidence rate for SAEs per 100 patient years (n=1292 patient years) was 18.6 and 362.8 for AEs. During the open-label period, most discontinuations were due to AEs (3.3 percent), withdrawal of consent (2.5 percent) and lack of efficacy (2.4 percent).
Adverse events, such as headache and upper respiratory tract infections, were similar in the two-year long-term extension trials to those seen in the double-blind trials.
In Europe, a marketing authorisation application for abatacept has been submitted to the European Medicines Agency (EMEA).
[1] Luggen M, Emery P, Li T, McCann T, Teng J, Schiff M. Abatacept provided clinically meaningful improvements in multiple aspects of health related quality of life (HRQoL) and physical function through 2 years of treatment in patients with active rheumatoid arthritis (RA): results from the AIM and ATTAIN trials. Poster presentation Monday, November 13, 2006, Poster no 980 at: American College of Rheumatology annual scientific meeting. Washington DC, November 10-15, 2006.
[2] Dougados M, Russell A, Li T, Sherrer Y, Teng J, McCann T, Westhovens R. Abatacept provides sustained improvements in pain, fatigue and sleep quality through 2 years in the treatment of rheumatoid arthritis patients in the AIM and ATTAIN trials. Poster presentation Sunday, November 12, 2006, poster no 502 at: American College of Rheumatology annual scientific meeting. Washington DC, November 10-15, 2006.
[3] Genovese M, Schiff M,Luggen M, Becker J-C, Aranda R, McCann T,Schmidely N, Le Bars M, Dougados M, Sustained Efficacy and Safety Through 2 Years in Patients with Rheumatoid Arthritis in the Long-term Extension of the ATTAIN Trial. Poster presentation Sunday, November 12, 2006, Poster no 498 at: American College of Rheumatology annual scientific meeting. Washington DC, November 10-15, 2006.
[4] Weinblatt, B Combe, C Birbara, A Covucci, T Li, J-C Becker, R Aranda, E Keystone. Safety and Patient-reported Outcomes Through 2 Years of Treatment with Abatacept in Rheumatoid Arthritis Patients Receiving Background Disease-modifying Antirheumatic Drugs (DMARDs): The ASSURE Trial. Poster presentation Sunday, November 12, 2006, poster no 509 at: American College of Rheumatology annual scientific meeting. Washington DC, November 10-15, 2006.
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