A new drug manufactured by Valeant Pharmaceuticals was approved by the U.S. FDA on February 15th, 2017. The medication, Siliq (brodalumab), is indicated for use by individuals with moderate-to-severe plaque psoriasis who are candidates for systemic or phototherapy. Specifically, it is recommended for use by individuals who have stopped responding to, or who have failed to respond to systemic treatments. The medication is in injection format, and the main ingredient, brodalumab, inhibits the inflammatory response responsible for plaque formation by binding to a crucial protein in the inflammatory pathway (specifically it inhibits interleukin-17 receptor A).
Over 4,373 individuals with moderate-to-severe plaque psoriasis have participated in the three main clinical studies that have proved Siliq’s efficacy and safety. Notably, in the placebo-controlled, randomized studies, those taking Siliq experienced a much greater level of skin clearing than their counterparts in the control group without Siliq. Some reported complete skin clearing.
Possible side effects
The most common side effects included fungal infections, nausea, low white blood cell counts, diarrhea, fatigue, muscle pain, influenza, injection site irritation, headache, throat pain, and joint pain. Siliq is not intended for use by individuals with Crohn’s disease, and individuals starting Siliq should be tested for tuberculosis (TB) prior to treatment. While on Siliq, it is advised that individuals refrain from receiving any live vaccines. Since Siliq affects the body’s immune response, an increased susceptibility to infection is possible.
The biggest concern with Siliq in the clinical trials was its effect on the mental health of those taking it. There was an increase in amount of suicidal ideation and behavior during the trials for those taking Siliq. Some completed suicides were also reported. This risk was increased for individuals who had a history of previous suicidal ideas and behavior, as well as depression. Because of this, the drug has been approved with an FDA-ordered accompanying boxed label warning. In spite of this warning, the FDA notes that there is no established causal relationship between the drug and increased risk of suicide.
The warning indicates that Siliq is only available under a controlled and restricted program called REMS (Risk Evaluation and Mitigation Strategy). The stipulations of this program include that only providers and pharmacies certified with the program can prescribe and distribute Siliq. Physicians are expected to counsel their patients on the risk of mood changes, and pharmacies are restricted from distributing Siliq to anyone not authorized to receive the drug. Further, individuals seeking Siliq are expected to sign a Patient-Prescriber Agreement Form, stating that they are aware of the risk and will seek medical attention if they experience mood changes, anxiety, depression, or suicidal thoughts or behaviors. Physicians are expected to refer individuals reporting these symptoms to a mental health professional.
“FDA approves new psoriasis drug.” U.S. Food and Drug Administration. 16 Feb 2017. Available from: http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm541981.htm