A safety review of biologic therapies for the management of hidradenitis suppurativa and unmet needs

Expert Opin Drug Saf. 2021 Oct;20(10):1147-1161. doi: 10.1080/14740338.2021.1924147. Epub 2021 May 12.

Abstract

Introduction: Hidradenitis suppurativa (HS) is a chronic, debilitating inflammatory skin disorder characterized by nodules, abscesses, fistulae, and significant scarring in intertriginous areas rich in apocrine glands. Immunomodulator drugs, including biologics, are a mainstay of treatment for this disease.

Areas covered: This review details the safety profiles of various biologic therapies currently available commercially that have been tried for HS as assessed in clinical trials and observational studies. As the only Food and Drug Administration (FDA)-approved medication for the treatment of moderate-to-severe HS, adalimumab is discussed in the most detail. Additional biologic medications, including tumor necrosis factor α (TNFα) inhibitors, interleukin 1 (IL-1) inhibitors, IL-12 and IL-23 inhibitors, IL-17 inhibitors, and IL-23 inhibitors, are discussed as well. Safety concerns in special populations, including pregnant women and children, are outlined.

Expert opinion: Existing data support excellent short-term and long-term safety profiles for adalimumab, although caution must be taken with use in high-risk patient populations, including those with chronic infections or increased risk of malignancy. Based on their safety data for other indications, additional biologic agents appear safe in HS as well. However, further research is needed to fully understand the safety profiles of these medications in the HS population.

Keywords: Hidradenitis suppurativa; adalimumab; anakinra; biologic therapy; guselkumab; infliximab; safety; secukinumab; ustekinumab.

Publication types

  • Review

MeSH terms

  • Adalimumab / administration & dosage
  • Adalimumab / adverse effects
  • Biological Products / administration & dosage*
  • Biological Products / adverse effects
  • Biological Therapy / adverse effects
  • Biological Therapy / methods
  • Health Services Needs and Demand
  • Hidradenitis Suppurativa / drug therapy*
  • Hidradenitis Suppurativa / physiopathology
  • Humans
  • Immunologic Factors / administration & dosage*
  • Immunologic Factors / adverse effects
  • Immunologic Factors / pharmacology
  • Time Factors

Substances

  • Biological Products
  • Immunologic Factors
  • Adalimumab