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

Summary 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 With the exception of efalizumab, which has been withdrawn from both the European and U.S. markets due to long‐term safety concerns, these biologics are generally well tolerated in long‐term studies, and offer a viable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.