New Psoriasis Drug Approved in U.S., But with a Warning — Physician’s First Watch
New Psoriasis Drug Approved in U.S., But with a Warning
By Kelly Young
The FDA has approved brodalumab (Siliq) to treat moderate-to-severe plaque psoriasis in adults who are eligible for systemic therapy or phototherapy and have not responded to other systemic treatments.
In three randomized trials of 4400 patients, brodalumab users saw better skin clearance than placebo users.
The injectable drug, which targets the interleukin-17A receptor, will come with a boxed warning about a possible risk for suicidal ideation. In clinical trials, patients with a history of suicidality or depression had a higher rate of suicidal ideation and behavior than those without similar histories. So far, there is no proven causal link between the drug and suicidality.
Other possible risks include the potential for serious infections or autoimmune or allergic conditions. The drug is contraindicated in patients with Crohn disease or active tuberculosis infection. Before treatment with brodalumab, patients should be evaluated for TB. Patients taking the drug should not be immunized with live vaccines