A safety review of recent advancements in the treatment of psoriasis: analysis of clinical trial safety data

Expert Opin Drug Saf. 2019 Jun;18(6):523-536. doi: 10.1080/14740338.2019.1614561. Epub 2019 May 14.

Abstract

Introduction: The management of psoriasis can include oral medications and injectable biologics. Safety data of these various treatment options are important to consider when choosing the right treatment for the patient.

Areas covered: This review evaluates the safety of newer treatments approved for psoriasis, including interleukin-(IL)-17 inhibitors, IL-23/p19 inhibitors, ustekinumab, certolizumab pegol and apremilast, using phases III and IV clinical trial data.

Expert opinion: Even as treatment of psoriasis becomes safer, it is important to recognize both common and uncommon adverse effects of treatment. Common adverse effects are similar across treatment options, including upper respiratory infection and injection-site reaction. Serious adverse effects occur less frequently and specific to the psoriasis treatment option, such as inflammatory bowel disease and candida infections with IL-17 inhibitors, tuberculosis with certolizumab pegol, and psychiatric events with apremilast. While IL-23/p19 inhibitors may have a slightly better safety profile than other biologics, long-term data are limited. The conclusions that can be drawn from clinical trial safety data are limited given that many clinical trials are not large enough to detect rare safety events. Data from registries provide important complementary information on long-term safety but there are limitations including a lack of randomized assignment between drug treatments.

Keywords: Psoriasis; adverse effects; apremilast; biologics; biosimilars; clinical trials; safety.

Publication types

  • Review

MeSH terms

  • Administration, Oral
  • Biological Products / administration & dosage*
  • Biological Products / adverse effects
  • Certolizumab Pegol / administration & dosage
  • Certolizumab Pegol / adverse effects
  • Dermatologic Agents / administration & dosage*
  • Dermatologic Agents / adverse effects
  • Humans
  • Injections
  • Psoriasis / drug therapy*
  • Thalidomide / administration & dosage
  • Thalidomide / adverse effects
  • Thalidomide / analogs & derivatives
  • Ustekinumab / administration & dosage
  • Ustekinumab / adverse effects

Substances

  • Biological Products
  • Dermatologic Agents
  • Thalidomide
  • Ustekinumab
  • Certolizumab Pegol
  • apremilast