Fortunately for patients who do not respond to other psoriasis treatments already on the market, the U.S. Food and Drug Administration has recently approved a new injectable drug, called Siliq (broadalumab) for treating mild-to-severe symptoms in adults.
Health Officials Promote Caution
However, Siliq will be distributed with a “black box” warning, because of its association with suicidal thoughts and behavior. Hence, only Risk Evaluation and Mitigation Strategy (REMS) certified physicians will be able to prescribe the new psoriasis drug and only to patients who do not respond – or don’t do so any more – to other systemic injectable medicines, oral treatments, or phototherapy.
Six suicides have been reported during the six clinical trials tallying more than 6,000 participants. All of the deceased were taking Siliq. Moreover, health officials say people with a history of depression, anxiety, or suicide attempts are most at risk of suicidal behavior and ideation. Patients who will receive Siliq will be required to check in regularly with their healthcare provider if mood worsening or anxiety occurs, officials say.
Siliq’s Unicity
Health experts describe plaque psoriasis as an autoimmune condition that causes cells to accumulate on the surface of the patient’s skin, subsequently forming flaky silver-white scales and thick reddish patches. At the moment, there are some forms of treatment available, including an array of systemic drugs delivered to the patient either orally, through an IV infusion, or via injection. Other forms of treatment consist of phototherapy (using a laser or an UV light box) and corticosteroids.
While other treatments work by binding to the interleukin-17 protein (a known contributor to the inflammation), the new psoriasis drug block the receptor completely, keeping the body from receiving certain signals that fuel inflammatory response and subsequently speed up psoriasis progression.
Side Effects
Researchers investigating Siliq’s potency revealed that more than half of the Phase 3 participants achieved total skin clearance within a year. However, physicians warn the treatment comes with an array of side effects, including flu, fatigue, muscle pain, nausea, headaches, diarrhea, low white blood cell count, throat pain, reactions at the injection site, and fungal infections.
A release date has not been communicated yet, but officials say the production and distribution will start sometime in the second quarter of 2017.
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