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Drug Safety Evaluation

Long-term safety of adalimumab for patients with moderate-to-severe hidradenitis suppurativa

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Pages 381-393 | Received 05 Jan 2020, Accepted 21 Feb 2020, Published online: 28 Feb 2020
 

ABSTRACT

Introduction: Hidradenitis suppurativa (HS) is a chronic debilitating inflammatory skin disorder that affects regions rich in apocrine glands. Although the etiology of HS is not clear, inflammatory cytokines, like tumor necrosis factor (TNF)-α, participate in pathogenesis. Adalimumab (ADA), a human IgG1 monoclonal antibody that selectively targets TNFα, is the only EMA/FDA-approved biologic agent available for the therapy of moderate-to-severe HS.

Areas covered: A comprehensive literature search was conducted to present existing studies with an emphasis on the safety profile of ADA for the treatment of moderate-to-severe HS. ADA is prescribed for more than 15 years for varied indications and has improved the therapeutic outcomes of many diseases. Clinical trials and real-life safety data from ADA administration in HS were presented, with particular attention to special populations, such as children, elderly, and pregnant women.

Expert opinion: Existing data advise for limited safety concerns with long-term ADA treatment provided that patients are thoroughly screened for infections, latent tuberculosis, and history of malignancy before the start of treatment.

Box 1. Drug summary.

Declaration of Interest

EJ Giamarellos-Bourboulis has received honoraria from AbbVie USA, Abbott CH, Biotest Germany, Brahms GmbH, InflaRx GmbH, MSD Greece, XBiotech Inc., and Angelini Italy; independent educational grants from AbbVie, Abbott, Astellas Pharma Europe, AxisShield, bioMérieux Inc, InflaRx GmbH, the Medicines Company, and XBiotech Inc.; and funding from the FrameWork 7 program HemoSpec (granted to the National and Kapodistrian University of Athens), and the Horizon2020 Marie Curie Project European Sepsis Academy (granted to the National and Kapodistrian University of Athens). The authors have no other relevant affiliations or financial involvement with any organization or entity with a financial interest in or financial conflict with the subject matter or materials discussed in the manuscript apart from those disclosed.

Reviewer Disclosures

A peer reviewer of this manuscript discloses serving on an advisory board and as an investigator for UCB and Abbvie. Peer reviewers on this manuscript have no other relevant financial or other relationships to disclose.

Additional information

Funding

This paper was not funded.

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