Objectives: Clinical trials of tumour necrosis factor antagonists have raised questions about the potential risk of certain serious adverse events (SAE). 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 and juvenile idiopathic arthritis (JIA) to 15 April 2007. Events per 100 patient-years were calculated using SAE reported after the first dose to 70 days after the last dose. Standardised incidence rates were calculated for malignancies using national and state-specific databases. Standardised mortality rates (SMR) were calculated for each disease using data from the World Health Organization.
Results: Cumulative rates of SAE of interest in RA have remained stable over time. Rates of SAE of interest for PsA, AS, CD, psoriasis 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. SMR 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.
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▸ Additional supplemental table 1 is published online only at http://ard.bmj.com/content/vol68/issue12
Funding This study was supported by Abbott Laboratories.
Competing interests JP and ALP are employees of Abbott Laboratories. GRB has served as a consultant with Abbott Laboratories, Essex/Schering-Plough, Novartis, Roche and has received grants from Abbott Laboratories, Essex/Schering-Plough, Novartis, Roche, Wyeth and honoraria from Abbott Laboratories, Essex/Schering-Plough, Novartis, Roche and Wyeth. BACD has served as a consultant with Abbott, Centocor, Schering-Plough and has received grants from Abbott, Centocor, Schering-Plough and received honoraria from Abbott, Centocor and Schering-Plough. KG has served as a consultant with and has received grants and honoraria from Abbott Laboratories. DL has served as a consultant with Abbott Laboratories, Amgen, Centocor, Hoffmann-La Roche, Novartis, Pfizer, Regeneron, Xoma and has received grants from Abbott Laboratories, Amgen, Bristol-Myers Squibb, Centocor, Hoffmann-La Roche, Regeneron, Roche and honoraria from Wyeth Pharmaceuticals. RP has served as a consultant with Abbott Laboratories, AstraZeneca, Bristol-Myers Squibb, Centocor, Elan, Ferring, GlaxoSmithKline, Procter and Gamble, Schering-Plough, Shire, UCB and has received grants from Abbott Laboratories, Axcan, Bristol-Myers Squibb, Centocor, Elan, Millennium, Procter and Gamble and has received honoraria from Abbott, Astra Zeneca, Byk Solvay, Centocor, Elan, Janssen, Procter and Gamble, Prometheus, Schering-Plough and Shire. PM has received grants and honoraria from Abbott Laboratories.
Ethics approval Ethics approval was obtained.
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