OP0233 Long-term safety of adalimumab in adult patients from global clinical trials across multiple indications: an updated analysis in 29,987 patients representing 56,951 patient-years
Authors: G. Burmester, R. Panaccione, K. Gordon, J. Rosenbaum, D. Arikan, W. Lau, R. Tarzynski-Potempa
Journal: Annals of the Rheumatic Diseases (2018)

<h3>Background</h3> Adalimumab is an anti–tumour necrosis factor-α (TNF-α) agent indicated for the treatment of immune-mediated diseases. The long-term safety of adalimumab was previously reported in 23 458 patients representing up to 12 years of clinical trial exposure in rheumatoid arthritis (RA), juvenile idiopathic arthritis, ankylosing spondylitis (AS), psoriatic arthritis (PsA), plaque psoriasis (Ps), and Crohn's disease (CD). <h3>Objectives</h3> Here we report an updated analysis examining the long-term safety of adalimumab in adult patients with RA, AS, non-radiographic axial spondyloarthritis (nr-axSpA), peripheral SpA (pSpA), PsA, Ps, hidradenitis suppurativa (HS), CD, ulcerative colitis (UC), and non-infectious uveitis (UV). <h3>Methods</h3> Here we report an updated analysis examining the long-term safety of adalimumab in adult patients with RA, AS, non-radiographic axial spondyloarthritis (nr-axSpA), peripheral SpA (pSpA), PsA, Ps, hidradenitis suppurativa (HS), CD, ulcerative colitis (UC), and non-infectious uveitis (UV). <h3>Results</h3> This analysis included 29 987 patients, representing 56 951 patient-years of exposure (table 2). The majority of adalimumab exposure was in RA studies. The most frequently reported SAE of interest was infection (highest incidences in CD, RA, UV, and UC). Overall and for most of the adalimumab populations (AS, PsA, Ps, UC, CD, and RA), the observed number of deaths was below what would be expected in an age- and sex–adjusted population (table 1). For HS, nr-axSpA, pSpA, and UV studies, the small size of these trials precluded accurate assessment of the standardised mortality ratio, and the 95% CIs all included 1.0. <h3>Conclusions</h3> This analysis of data from clinical trials of adalimumab demonstrated an overall safety profile consistent with previous findings and with the TNF inhibitor class. No new safety signals or tolerability issues with adalimumab treatment were identified and, for most indications, the mortality rate was below what would be expected in an age- and sex–adjusted population. Efficacy and safety data continue to support the well-established benefits of adalimumab for the approved indications. <h3>Acknowledgements</h3> AbbVie funded the study, contributed to its design, and participated in data collection, analysis and interpretation of the data, and in writing, review, and approval of the publication. Medical writing (funded by AbbVie): Maria Hovenden, PhD, and Janet Matsuura, PhD, of CPS. <h3>Disclosure of Interest</h3> G. Burmester Grant/research support from: AbbVie, Bristol-Myers Squibb, Merck, Pfizer, Roche, and UCB, Consultant for: AbbVie, Bristol-Myers Squibb, Merck, Pfizer, Roche, and UCB, Speakers bureau: AbbVie, Bristol-Myers Squibb, Merck, Pfizer, Roche, and UCB, R. Panaccione Grant/research support from: Abbott Laboratories, Axcan, Bristol-Myers Squibb, Centocor, Elan, Millenium, and Procter and Gamble; honoraria from Abbott Laboratories, AstraZeneca, Byk Solvay, Centocor, Elan, Janssen, Procter and Gamble, Prometheus, Schering-Plough, and Shire, Consultant for: Abbott Laboratories, AstraZeneca, Bristol-Myers Squibb, Centocor, Elan, Ferring, GlaxoSmithKline, Procter and Gamble, Schering-Plough, Shire, and UCB, K. Gordon Grant/research support from: AbbVie, Amgen, Boehringer Ingelheim, Eli Lilly, and Janssen, Consultant for: AbbVie, Amgen, Boehringer Ingelheim, Celgene, Eli Lilly, Janssen, Novartis, and Pfizer, J. Rosenbaum Shareholder of: Royalties: UptoDate, Grant/research support from: Alcon Research Institute, Consultant for: Abbvie, Gilead, Santen, Regeneron, UCB, Cavtherx, Portage, Eyevensys, and Stem Cell Inc, Speakers bureau: Mallinckrodt, D. Arikan Shareholder of: AbbVie, Employee of: AbbVie, W. Lau Shareholder of: AbbVie, Employee of: AbbVie, R. Tarzynski-Potempa Shareholder of: AbbVie, Employee of: AbbVie