Long-Term Safety of Adalimumab in Immune-Related Diseases Analyzed
Infections were the highest reported SAE, with incidences most frequent in patients with CD, RA, UV, and UC.
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San Diego — The use of adalimumab in arthritis and other immune-related diseases is safe and provides a favorable tolerability profile across most indications, according to findings from a study presented at the 2017 ACR/ARHP Annual Meeting held November 3-8.
The investigators in this analysis sought to determine the long-term safety of adalimumab use in patients with rheumatoid arthritis (RA), ankylosing spondylitis (AS), plaque psoriasis (Ps), ulcerative colitis (UC), hidradenitis suppurativa (HS), non-infectious uveitis (UV), non-radiographic axial spondyloarthritis (nr-axSpA), psoriatic arthritis (PsA), and Crohn disease (CD).
Researchers analyzed data from 78 trials that used adalimumab for these indications. Specifically, researchers examined adverse events (AEs) as well as serious AEs (SAEs) following the first study dose of adalimumab and up to 70 days following the final study dose.
A total of 29,987 patients were represented in this study. Infections were the highest reported SAE, with incidences most frequent in patients with CD, RA, UV, and UC. Mortality was lower than expected, particularly in patients with AS, CD, Ps, PsA, RA, and UC. Studies that evaluated mortality outcomes in patients with HS, nr-axSpA, pSpA, and UV featured sample sizes that were too small to conclude significant survival benefits associated with adalimumab use.
Lead investigator Dr Gerd R. Bermester of the Clinic for Rheumatology and Clinical Immunology at Charité-Universitätsmedizin Berlin in Germany and colleagues concluded that the current safety and efficacy data on adalimumab “continue to support the well-established benefits of adalimumab for the approved indications.”
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Burmester GR, Panaccione R, Gordon KB, et al. Long-term safety of adalimumab (HUMIRA) in adult patients from global clinical trials across multiple indications: an updated analysis in 29,987 patients representing 56,951 patient-years. Presented at: ACR/ARHP 2017 Annual Meeting; November 3-8, 2017; San Diego, California. Abstract 2481.