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Adalimumab: long-term safety in 23 458 patients from global clinical trials in rheumatoid arthritis, juvenile idiopathic arthritis, ankylosing spondylitis, psoriatic arthritis, psoriasis and Crohn's disease
Annals of Rheumatic Diseases, 07/17/2012
Clinical Article
Burmester GR et al. – Analysis of adverse events of interest through nearly 12 years of adalimumab exposure in clinical trials across indications demonstrated individual differences in rates by disease populations, no new safety signals and a safety profile consistent with known information about the anti–tumour necrosis factor (TNF) class.
Methods- This analysis included 23 458 patients exposed to adalimumab in 71 global clinical trials in RA, juvenile idiopathic arthritis, ankylosing spondylitis (AS), psoriatic arthritis, psoriasis (Ps) and Crohn's disease (CD).
- Events per 100 patient–years were calculated using events reported after the first dose through 70 days after the last dose.
- Standardised incidence rates for malignancies were calculated using a National Cancer Institute database.
- Standardised death rates were calculated using WHO data.
- The most frequently reported serious adverse events across indications were infections with greatest incidence in RA and CD trials.
- Overall malignancy rates for adalimumab–treated patients were as expected for the general population; the incidence of lymphoma was increased in patients with RA, but within the range expected in RA without anti–TNF therapy; non–melanoma skin cancer incidence was raised in RA, Ps and CD.
- In all indications, death rates were lower than, or equivalent to, those expected in the general population.
