RESEARCH - Malignancies in the RA Orencia clnical development program

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Ann Rheum Dis 2009;68:1819-1826 doi:10.1136/ard.2008.097527

Clinical and epidemiological research

Extended report

Malignancies in the rheumatoid arthritis abatacept clinical

development programme: an epidemiological assessment

T A Simon1, A L Smitten1, J lin2, J Askling3, D Lacaille4, F

Wolfe5, M C Hochberg6, K Qi7, S Suissa8

+ Author Affiliations

1Global Epidemiology, Bristol-Myers Squibb, Hopewell, New Jersey, USA

2ARC Epidemiology Unit, University of Manchester, Manchester, UK

3Epidemiology, Karolinska University Hospital Solna, Stockholm, Sweden

4Arthritis Research Centre of Canada, University of British Columbia,

Vancouver, Canada

5National Data Bank for Rheumatic Diseases, Arthritis Research

Foundation and University of Kansas, Wichita, Kansas, USA

6Departments of Medicine and Epidemiology and Preventive Medicine,

University of land School of Medicine, Baltimore, land, USA

7Global Biostatistics, Bristol-Myers Squibb, Hopewell, New Jersey, USA

8Division of Clinical Epidemiology, McGill University, Montreal, Canada

Abstract

Objective: To provide context for the malignancy experience in the

rheumatoid arthritis (RA) abatacept clinical development programme

(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

antirheumatic drugs (DMARD) identified from five 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 (IR) and standardised incidence ratios

(SIR) were used to compare events in the abatacept trials with the RA

DMARD cohorts and the general population.

Results: A total of 4134 RA patients treated with abatacept in seven

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

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

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

two cases of colorectal, 13 cases of lung cancer and five cases of

lymphoma observed were not greater than the range of expected cases

from the five RA cohorts. The SIR comparing RA patients with the

general population were consistent with those reported in the

literature.

Conclusions: The IR 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/content/68/12/1819.abstract?etoc

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