Background As long-term treatment with anti-tumour necrosis factor (TNF) drugs becomes accepted practice, the risk assessment of prolonged administration requires understanding of anti-TNF long-term safety. Rates of adverse events (AE) in patients (pts) treated with anti-TNF therapy can vary across therapeutic indications due to differences in disease-inherent risks, comorbidities, and use of concomitant immunosuppressant drugs.

Objectives To assess and compare adalimumab’s (ADA) long-term safety profile through nearly 12 years of clinical trial exposure in 6 pt populations.

Methods Safety data from pts treated with ADA in 71 global clinical trials in rheumatoid arthritis (RA), juvenile idiopathic arthritis, ankylosing spondylitis, psoriatic arthritis, psoriasis (Ps), and Crohn’s disease (CD) were analyzed. Events per 100 patient-years (PYs) were calculated using events reported after first dose through 70 days after last dose. Standardized incidence rates (SIR) for malignancies were calculated using a National Cancer Institute database. Standardized mortality rates (SMR) were calculated using WHO data.

Results ADA was administered to 23,458 pts, representing 36,730.5 PYs of exposure. Serious infections were the most frequently reported serious AEs across indications with the greatest incidence in RA and CD trials (table). Overall malignancy SIRs for ADA-treated pts were as expected in the general population; SIR of lymphoma was elevated in RA pts, but within the range expected in RA pts without anti-TNF therapy. Non-melanoma skin cancer SIR was elevated in RA, Ps, and CD pts. In all indications, SMRs were lower than or equivalent to those expected in the general population.

Conclusions These data provide support for the long-term safety of adalimumab in 6 immune-mediated inflammatory diseases, highlight individual differences in rates by disease populations, and demonstrate a safety profile consistent with known information about the anti-TNF class.

Disclosure of Interest G. Burmester Grant/Research support from: Abbott, Essex/Schering-Plough, Novartis, Roche, Wyeth, Consultant for: Abbott, Essex/Schering-Plough, Novartis, Roche, R. Panaccione Grant/Research support from: Abbott, Axcan, Bristol-Myers Squibb, Centocor, Elan, Millennium, Procter & Gamble, Consultant for: Abbott, Astra-Zeneca, Bristol-Myers Squibb, Byk Solvay, Centocor, Elan, Ferring, GlaxoSmithKline, Janssen, Procter & Gamble, Prometheus, Schering-Plough, Shire, UCB, K. Gordon Grant/Research support from: Abbott, Amgen, Centocor, Celgene, Consultant for: Abbott, Amgen, Centocor, Galderma, Lilly, Merck, Pfizer, M. McIlraith Shareholder of: Abbott, Employee of: Abbott, A. Lacerda Shareholder of: Abbott, Employee of: Abbott