FDA approves new injectable drug for psoriasis

Psoriasis – a chronic disease in which there is an abnormally rapid growth and death of skin cells. So, under normal conditions, the life cycle of cells is about 30-40 days, and with psoriasis – 4–5 days.  Since the body does not have time to get rid of dead skin cells, they accumulate on its surface, forming plaques and peeling characteristic of this disease. About 3.5% of the world's population is faced with this problem. At the same time, psoriasis vulgaris (plaque psoriasis) – the most common form of the disease for which the new injectable Siliq has been approved.

Siliq (brodalumab) approved by the FDA for the treatment of psoriasis

On February 15, 2017, Siliq (brodalumab) was approved by the FDA for the treatment of adult patients with moderate to severe plaque psoriasis. Siliq is injected.

Siliq is intended for patients who have not been successfully treated with systemic or phototherapy.

Julie Beitz, director of the FDA's Center for Drug Evaluation and Research, Phase III Drug Evaluation Division, said: “Moderate to severe plaque psoriasis can cause severe skin irritation and discomfort in patients. The approved drug is another treatment for psoriasis. Patients should discuss the benefits and risks associated with Siliq before starting treatment.

Siliq:

mechanism of action;
side effects.

Mechanism of action of Siliq for the treatment of psoriasis

The safety and efficacy of Siliq was studied in three randomized, placebo-controlled clinical trials in 4 373 adults with moderate to severe psoriasis vulgaris who were candidates for systemic or phototherapy. Many patients who have been treated with Siliq have experienced a significant improvement in their skin condition or even complete resolution of their psoriasis.

The active ingredient in Siliq (brodalumab) binds to a protein that triggers inflammation by suppressing the inflammatory response – an important factor in the development of plaque psoriasis.

Siliq is a monoclonal antibody that binds to interleukin-17 (IL-17) receptors and suppresses pro-inflammatory signaling by preventing several types of IL-17 from binding to the receptors. By blocking the activation of IL-17 receptors, Siliq prevents the signals that lead to inflammation. The IL-17 signaling pathway plays a central role in the induction of inflammatory processes.

Because Siliq therapy is systemic, meaning it affects the entire body, it is effective in treating psoriasis anywhere on the body.

Side effects of Siliq for psoriasis

Siliq is relatively new, so the FDA only recommends Siliq therapy when other (more well-researched) treatments fail to resolve the problem.

This recommendation is partly due to the rather impressive list of possible side effects of the injectable psoriasis drug:

joint pain;
headaches;
fatigue;
diarrhea;
pain in the oropharynx;
nausea;
muscle pain;
reactions at the injection site;
neutropenia;
fungal infections;
suicidal behavior.

Because Siliq suppresses the activity of the immune system, when using this drug for the treatment of psoriasis, the risk of infection, allergic reactions, may increase. Siliq is contraindicated in patients with Crohn's disease and tuberculosis. Immunization with live vaccines is contraindicated during treatment with Siliq.

A warning about the increased risk of suicidal behavior in case of treatment of psoriasis with Siliq is printed directly on the package, and the drug is only allowed to be used in accordance with the Siliq REMS Program.