Long-term safety of biologics in the treatment of moderate-to-severe plaque psoriasis: review of current data

Br J Dermatol. 2012 Nov:167 Suppl 3:3-11. doi: 10.1111/j.1365-2133.2012.11208.x.

Abstract

Conventional non-biologic systemic agents are regarded as second-line therapy for the treatment of moderate-to-severe plaque psoriasis after topical treatments. However, long-term data have highlighted a number of safety concerns associated with their prolonged use. Biologic agents targeting specific immune mediators have emerged as an alternative treatment option for patients with moderate-to-severe plaque psoriasis who are unresponsive to, or intolerant of, non-biologic systemic agents. Although several biologics have demonstrated good efficacy and tolerability in short-term trials, treatment guidelines recommend them as third-line therapies due to a relative lack of long-term safety data. Here, we have reviewed the long-term (≥ 1 year) safety data from randomized controlled trials, open-label extension studies and meta-analyses of etanercept, infliximab, efalizumab, adalimumab, alefacept and ustekinumab in the treatment of adults with moderate-to-severe plaque psoriasis. With the exception of efalizumab, which has been withdrawn from both the European and U.S. markets due to long-term safety concerns, these biologics are generally well tolerated in long-term studies, and offer a viable alternative to conventional non-biologic agents in patients with moderate-to-severe plaque psoriasis.

Publication types

  • Review

MeSH terms

  • Antibodies, Monoclonal / adverse effects
  • Biological Products / adverse effects*
  • Dermatologic Agents / adverse effects*
  • Female
  • HIV Infections / complications
  • Hepatitis B, Chronic / complications
  • Hepatitis C, Chronic / complications
  • Humans
  • Pregnancy
  • Pregnancy Complications / drug therapy
  • Preoperative Care / methods
  • Psoriasis / drug therapy*
  • Randomized Controlled Trials as Topic
  • Recombinant Fusion Proteins / adverse effects

Substances

  • Antibodies, Monoclonal
  • Biological Products
  • Dermatologic Agents
  • Recombinant Fusion Proteins