Prescribing Barriers in Psoriasis

This is interesting because of the possibility that reducing the effect of an immune factor could lead to depression (not proven though)...

https://goo.gl/RwnHos

In February, the FDA approved brodalumab (Siliq, from Valeant Pharmaceuticals) for adults with moderate-to-severe plaque psoriasis. The injectable biologic shines for its impact on the disease. In one phase III study published in 2015 in the New England Journal of Medicine, researchers reported that 44% of psoriasis patients taking 210 mg of brodalumab every two weeks had a complete response, or Psoriasis Area and Severity Index (PASI) 100, at week 12, and 86% achieved PASI 75.

Dermatologists who plan to prescribe brodalumab may face a rough road. Concerns about increased risks of suicidal ideation and behavior in phase III studies were so great that the FDA approved brodalumab with a boxed warning and instituted a Risk Evaluation and Mitigation Strategy (REMS) program that raises barriers to prescribing the drug.

Four of them occurred in psoriasis patients; two occurred in psoriatic arthritis trials. The FDA has characterized this as a strong signal for suicidal ideation and completed suicide -- events that have not been observed to the same degree in other systemic psoriasis drug development programs," Leonardi said.

But there's more to this story.

"The other side of the argument," according to Leonardi, "is when you look at the number of events, it is not statistically significant. In a strict accounting sense, it's not known if these events are related. But what causes everybody to stop short is the serious nature of the event."