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

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
• biologic therapy
• safety
• adalimumab
• infliximab
• anakinra
• ustekinumab
• secukinumab
• guselkumab

Declaration of interest

AB Kimball is a consultant and investigator for Abbvie, Bristol Meyers Squibb, Janssen, Eli Lilly, Novartis, Pfizer, and UCB; investigator for ChemoCentryx; receives fellowship funding from Janssen and Abbvie; and served as previous Board Of Directors and Past President of the International Psoriasis Council, Board Of Directors of the HS Foundation, and Board of Directors for Almirall. ML Porter is a consultant and investigator for UCB, Pfizer, Eli Lilly, and Novartis and an investigator for Abbvie, Janssen, and Bristol Meyers Squibb. 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. This includes employment, consultancies, honoraria, stock ownership or options, expert testimony, grants or patents received or pending, or royalties.

Reviewer disclosures

Peer reviewers on this manuscript have no relevant financial or other relationships to disclose.

Article highlights

• Although hidradenitis suppurativa is a debilitating skin disease, various biologic medications are emerging as efficacious treatment options.

• Adalimumab has demonstrated an excellent safety profile in both short-term and long-term studies.

• Infliximab is also well studied, efficacious, and safe in this patient population with appropriate monitoring.

• Multiple additional biologic therapies, including inhibitors of IL-17, IL-23, and other targets, are currently being developed and studied for hidradenitis suppurativa.

• Medication decisions for biologic use in high-risk patients should be individualized and may require closer monitoring.

This box summarizes key points contained in the article.

Additional information

Funding

This paper was not funded.