RESEARCH - Malignancies in the RA Orencia clinical development program

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Ann Rheum Dis. Published Online First: 3 December 2008.

doi:10.1136/ard.2008.097527

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Extended Report

Malignancies in the rheumatoid arthritis abatacept clinical

development program: An epidemiological assessment

T A Simon 1*, A L Smitten 1, J lin 2, J Askling 3, D Lacaille 4,

F Wolfe 5, M C Hochberg 6, K Qi 1 and S Suissa 7

1 Bristol-Myers Squibb, United States

2 University of Manchester, United Kingdom

3 Karolinska University Hospital Solna, Sweden

4 University of British Columbia, Canada

5 Arthritis Research Foundation and University of Kansas, United States

6 University of land School of Medicine, United States

7 McGill University, Canada

Abstract

Objective: To provide context for the malignancy experience in the

rheumatoid arthritis (RA) abatacept clinical development program (CDP)

by performing comparisons with similar RA patients and the general

population.

Methods: Malignancy outcomes included total malignancy (excluding

non-melanoma skin cancer (NMSC)), breast, colorectal, lung cancers,

and lymphoma. Comparisons were made between the observed incidence in

patients within the abatacept CDP and RA patients on disease-modifying

anti-rheumatic drugs (DMARDs) identified from 5 data sources: the

population-based British Columbia RA Cohort, the Norfolk Arthritis

Register, the National Data Bank for Rheumatic Diseases, the Sweden

Early RA Register, and the General Practice Research Database. Age-

and sex-adjusted incidence rates (IRs) and standardized incidence

ratios (SIRs) were used to compare events in the abatacept trials to

the RA DMARD cohorts and the general population.

Results: A total of 4,134 RA patients treated with abatacept in 7

trials and 41,529 DMARD-treated RA patients in the 5 observational

cohorts were identified for study inclusion. In the abatacept-treated

patients, the 51 malignancies (excluding NMSC), 7 cases of breast, 2

cases of colorectal, 13 cases of lung cancer, and 5 cases of lymphoma

observed were not greater than the range of expected cases from the 5

RA cohorts. The SIRs comparing RA patients to the general population

were consistent with those reported in the literature.

Conclusions: The IRs of total malignancy (excluding NMSC), breast,

colorectal, lung cancers, and lymphoma in the abatacept CDP were

consistent with those in a comparable RA population. These data

suggest no new safety signals with respect to malignancies, which will

continue to be monitored.

http://ard.bmj.com/cgi/content/abstract/ard.2008.097527v1?papetoc

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