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Effects of Abatacept in Patients with Methotrexate-Resistant Active Rheumatoid Arthritis: A Randomized Trial

Joel M. Kremer, MD; Harry K. Genant, MD; Larry W. Moreland, MD; Anthony S. Russell, MD; Paul Emery, MD; Carlos Abud-Mendoza, MD; Jacek Szechinski, MD; Tracy Li, PhD; Zhiyu Ge, PhD; Jean-Claude Becker, MD; and Rene Westhovens, MD
[+] Article and Author Information

From the Center for Rheumatology, Albany, New York; University of California, San Francisco, and Synarc Inc., San Francisco, California; University of Alabama at Birmingham School of Medicine, Birmingham, Alabama; University of Alberta, Edmonton, Alberta, Canada; Leeds General Infirmary, Leeds, United Kingdom; Hospital Central, San Luis Potosi, Mexico; University of Medical Sciences, Wroclaw, Poland; Bristol-Myers Squibb, Princeton, New Jersey; and University Hospital Leuven, Leuven, Belgium.


ClinicalTrials.gov identifier: NTC00048568.

Grant Support: By Bristol-Myers Squibb.

Potential Financial Conflicts of Interest: Employment: T. Li (Bristol-Myers Squibb), Z. Ge (Bristol-Myers Squibb), J.-C. Becker (Bristol-Myers Squibb); Consultancies: J.M. Kremer (Bristol-Myers Squibb), H.K. Genant (Bristol-Myers Squibb, Amgen, Wyeth, Novartis, Lilly, Roche), L.W. Moreland (Bristol-Myers Squibb), A.S. Russell (Bristol-Myers Squibb), P. Emery (Amgen, Schering-Plough, Centocor, Bristol-Myers Squibb), R. Westhovens (Schering-Plough, Bristol-Myers Squibb); Honoraria: J.M. Kremer (Bristol-Myers Squibb), H.K. Genant (Bristol-Myers Squibb, Amgen, Wyeth, Novartis, Lilly, Roche), L.W. Moreland (Bristol-Myers Squibb), P. Emery (Wyeth, Roche), R. Westhovens (Schering-Plough, Bristol-Myers Squibb); Stock ownership or options (other than mutual funds): T. Li (Bristol-Myers Squibb), Z. Ge (Bristol-Myers Squibb), J.-C. Becker (Bristol-Myers Squibb); Grants received: J.M. Kremer (Bristol-Myers Squibb), H.K. Genant (Bristol-Myers Squibb, Amgen, Wyeth, Novartis, Lilly, Roche), L.W. Moreland (Bristol-Myers Squibb); Patents pending: J.-C. Becker (Bristol-Myers Squibb).

Requests for Single Reprints: Joel M. Kremer, MD, Center for Rheumatology, 1367 Washington Avenue, Suite 1, Albany, NY 12206; e-mail, jkremer@joint-docs.com.

Current Author Addresses: Dr. Kremer: Center for Rheumatology, 1367 Washington Avenue, Suite 1, Albany, NY 12206.

Dr. Genant: Radiology Department, University of California, San Francisco, 505 Parnassus Avenue, Box 0628, San Francisco, CA 94143-0628.

Dr. Moreland: 068 Spain Rehabilitation Center, University of Alabama at Birmingham, 1717 6th Avenue South, Birmingham, AL 35294.

Dr. Russell: Medical Department, University of Alberta Hospital, 562 Heritage Medical Research Centre, Edmonton, T6G 2S2 Alberta, Canada.

Dr. Emery: Academic Unit of Musculoskeletal Disease, Chapel Allerton Hospital, Chapeltown Road, Leeds LS7 4SA, United Kingdom.

Dr. Abud-Mendoza: Hospital Central, Av. Carranza 2395, San Luis Potosi, S.L.P. 78240, Mexico.

Dr. Szechinski: Department of Rheumatology, Medical University of Wroclaw, ul. Wiśniowa 36a, 53-137 Wrocław, Poland.

Drs. Li and Becker: Bristol-Myers Squibb, PO Box 4000, Princeton, NJ 08543.

Dr. Ge: 13133 Taylor Court, West Windsor, NJ 08550.

Dr. Westhovens: Rheumatology Department, University Hospitals, K.U. Leuven, Herestraat 49, 3000 Leuven, Belgium.

Author Contributions: Conception and design: J.M. Kremer, H.K. Genant, L.W. Moreland, A.S. Russell, P. Emery, T. Li, J.-C. Becker, R. Westhovens.

Analysis and interpretation of the data: J.M. Kremer, H.K. Genant, L.W. Moreland, P. Emery, C. Abud-Mendoza, T. Li, Z. Ge, J.-C. Becker, R. Westhovens.

Drafting of the article: J.M. Kremer, H.K. Genant, L.W. Moreland, A.S. Russell, T. Li, J.-C. Becker, R. Westhovens.

Critical revision of the article for important intellectual content: J.M. Kremer, H.K. Genant, L.W. Moreland, A.S. Russell, P. Emery, C. Abud-Mendoza, J. Szechinski, T. Li, J.-C. Becker, R. Westhovens.

Final approval of the article: J.M. Kremer, L.W. Moreland, A.S. Russell, P. Emery, C. Abud-Mendoza, J. Szechinski, J.-C. Becker, R. Westhovens.

Provision of study materials or patients: J.M. Kremer, A.S. Russell, P. Emery, C. Abud-Mendoza, J. Szechinski, R. Westhovens.

Statistical expertise: Z. Ge, J.-C. Becker.

Obtaining of funding: J.-C. Becker.

Administrative, technical, or logistic support: J.-C. Becker.

Collection and assembly of data: J.M. Kremer, P. Emery, J.-C. Becker.


Ann Intern Med. 2006;144(12):865-876. doi:10.7326/0003-4819-144-12-200606200-00003
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The institutional review boards or independent ethics committees approved a common clinical protocol for each site, and we performed the study in accordance with the ethical principles of the Declaration of Helsinki. All patients provided written informed consent to the study protocol before randomization.

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Figures

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Figure 1.
Study flow diagram.

*MTX = methotrexate. Nine abatacept-treated patients and 5 placebo recipients from 1 site were excluded from all efficacy analyses before unblinding due to nonadherence but were included in all safety analyses.

Grahic Jump Location
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Figure 2.
Improvements in signs and symptoms of disease and physical function.A–C.ACRpanel Apanel Bpanel CD.HAQ-DI

American College of Rheumatology ( ) 20 ( ), ACR 50 ( ), and ACR 70 ( ) responses over 1 year in all patients who received at least 1 dose of the study medication. The percentage of patients who achieved a Health Assessment Questionnaire Disability Index ( ) response (≥0.3-unit improvement from baseline in HAQ-DI) was determined over 1 year. MTX = methotrexate. *Intention-to-treat population where all dropouts were considered to be ACR nonresponders subsequent to their dropout. †Because of adherence issues identified during the study, patients from 1 site were excluded from all efficacy analyses before unblinding but were included in the analysis of safety.

Grahic Jump Location
Grahic Jump Location
Figure 3.
Slowing of radiographic structural damage progression at 1 year.JSNsolid circlesdotted lines

Interquartile range changes from baseline in Genant-modified Sharp erosion, joint-space narrowing ( ), and total scores were evaluated at 1 year or at early termination (if applicable). The median ( ), interquartile range, and 10th and 90th percentiles ( ) are shown. Data shown are from all randomly assigned and treated patients with baseline and follow-up radiography. MTX = methotrexate.

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Summary for Patients

Abatacept for People with Active Rheumatoid Arthritis

The summary below is from the full report titled “Effects of Abatacept in Patients with Methotrexate-Resistant Active Rheumatoid Arthritis. A Randomized Trial.” It is in the 20 June 2006 issue of Annals of Internal Medicine (volume 144, pages 865-876). The authors are J.M. Kremer, H.K. Genant, L.W. Moreland, A.S. Russell, P. Emery, C. Abud-Mendoza, J. Szechinski, T. Li, Z. Ge, J.-C. Becker, and R. Westhovens.

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