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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

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          Abstract

          Background

          As long-term treatment with antitumour necrosis factor (TNF) drugs becomes accepted practice, the risk assessment requires an understanding of anti-TNF long-term safety. Registry safety data in rheumatoid arthritis (RA) are available, but these patients may not be monitored as closely as patients in a clinical trial. Cross-indication safety reviews of available anti-TNF agents are limited.

          Objective

          To analyse the long-term safety of adalimumab treatment.

          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.

          Results

          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.

          Conclusions

          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-TNF class.

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          Author and article information

          Journal
          Ann Rheum Dis
          Ann. Rheum. Dis
          annrheumdis
          ard
          Annals of the Rheumatic Diseases
          BMJ Group (BMA House, Tavistock Square, London, WC1H 9JR )
          0003-4967
          1468-2060
          April 2013
          5 May 2012
          : 72
          : 4
          : 517-524
          Affiliations
          [1 ]Department of Rheumatology and Clinical Immunology, Charité University Hospital, Berlin, Germany
          [2 ]Department of Medicine, University of Calgary, Calgary, Canada
          [3 ]Department of Dermatology, Northwestern University, Chicago, Illinois, USA
          [4 ]Department of Rheumatology Medical Affairs, Abbott Laboratories, Rungis, France
          [5 ]Immunology Medical Affairs, Abbott Laboratories, Sao Paulo, Brazil
          Author notes
          [Correspondence to ] Professor G R Burmester, Department of Rheumatology and Clinical Immunology, Charité – University Medicine Berlin, Charitéplatz 1, 10117 Berlin, Germany; gerd.burmester@ 123456charite.de
          Article
          annrheumdis-2011-201244
          10.1136/annrheumdis-2011-201244
          3595151
          22562972
          Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://group.bmj.com/group/rights-licensing/permissions

          This is an open-access article distributed under the terms of the Creative Commons Attribution Non-commercial License, which permits use, distribution, and reproduction in any medium, provided the original work is properly cited, the use is non commercial and is otherwise in compliance with the license. See: http://creativecommons.org/licenses/by-nc/3.0/ and http://creativecommons.org/licenses/by-nc/3.0/legalcode

          Product
          Categories
          1506
          Clinical and Epidemiological Research
          Extended report
          Custom metadata
          unlocked

          Immunology

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