RESEARCH - Humira safety and mortality rates from global clinical trials of six immune-mediated inflammatory diseases

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Ann Rheum Dis. Published Online First: 15 January 2009.

doi:10.1136/ard.2008.102103

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Extended Report

Adalimumab safety and mortality rates from global clinical trials of

six immune-mediated inflammatory diseases

G R Burmester 1*, P J Mease 2, B AC Dijkmans 3, K Gordon 4, D Lovell

5, R Panaccione 6, J 7 and A L Pangan 7

1 Charité-University Medicine Berlin, Free University and Humboldt

University of Berlin, Germany

2 Swedish Medical Center, United States

3 VU Medical Centre and Jan van Breemen Institute, Netherlands

4 ton Northwestern Healthcare, United States

5 Cincinnati Children's Hospital Medical Center, United States

6 University of Calgary, Canada

7 Abbott Laboratories, United States

Abstract

Objectives: Clinical trials of tumour necrosis factor antagonists have

raised questions about the potential risk of certain serious adverse

events (SAEs). To assess the safety of adalimumab in rheumatoid

arthritis (RA) over time and across five other immune-mediated

inflammatory diseases and to compare adalimumab malignancy and

mortality rates with data on the general population.

Methods: This analysis included 19 041 patients exposed to adalimumab

in 36 global clinical trials in RA, psoriatic arthritis (PsA),

ankylosing spondylitis (AS), Crohn's disease (CD), psoriasis (Ps), and

juvenile idiopathic arthritis (JIA) through April 15, 2007. Events per

100-patient-years were calculated using serious adverse events

reported after the first dose through 70 days after the last dose.

Standardised incidence rates were calculated for malignancies using

national and state specific databases. Standardised mortality rates

(SMRs) were calculated for each disease using data from the World

Health Organization.

Results: Cumulative rates of SAEs of interest in RA have remained

stable over time. Rates of SAEs of interest for PsA, AS, CD, Ps, and

JIA were similar to or lower than rates for RA. Overall malignancy

rates for adalimumab treated patients were as expected for the general

population. SMRs across all six diseases indicated that no more deaths

occurred with adalimumab than expected in the general population.

Conclusions: Based on 10 years of clinical trial experience across six

diseases, this safety report and the established efficacy of

adalimumab in these diseases provide the foundation for a better

understanding of its benefit-risk profile.

http://ard.bmj.com/cgi/content/abstract/ard.2008.102103v1?papetoc

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