Plaque Psoriasis

The European Commission (EC) has approved risankizumab (Skyrizi, AbbVie) for the treatment of moderate to severe plaque psoriasis in adults who are candidates for systemic therapy. The action comes 2 months after the European Medicines Agency’s Committee for Medicinal Products for Human Use recommend approval of the drug.
Rizankizumab is a humanized monoclonal antibody that targets the p19 sub-unit of interleukin 23. It is given in two subcutaneous injections of 75 mg each every 12 weeks following two initiation doses at week. The approval was based on results from four phase 3 studies that involve more than 2000 patients with moderate to severe plaque psoriasis.

Psoriasis is a common skin condition

Psoriasis is a common skin condition that speeds up the life cycle of skin cells. It causes cells to build up rapidly on the surface of the skin. The extra skin cells form scales and red patches that are itchy and sometimes painful. Psoriasis is a chronic disease that often comes and goes. Psoriasis patches can range from a few spots of dandruff-like scaling; so to major eruptions that cover large areas.

Most types of psoriasis go through cycles, flaring for a few weeks or months; so then subsiding for a time or even going into complete remission. The main goal of treatment is to stop the skin cells from growing so quickly. There is no cure for psoriasis, but you can manage symptoms. Lifestyle measures, such as moisturizing, quitting smoking and managing stress.

In all four studies, all coprimary and ranked secondary endpoints were met. There was a significantly higher response to risankizumab; which patients experienced clear or almost clear skin (Static Physicians Global Assessment [sPGA] 0/1 and Psoriasis Area and Severity Index [PASI] 90); so compare to ustekinumab (Stelara, Janssen), adalimumab (Humira, AbbVie); placebo at week 16 and up to week 52 (depending on study design), according to AbbVie.

Higher rates of skin clearance

In clinical studies, patients saw significantly higher rates of skin clearance; so with Skyrizi compare to current standards of care,” Hervé Bachelez, PhD, of the Saint-Louis Hospital in Paris, France; who was principal investigator of one of the studies, said in a company news release. As many as 80% of patients who achieve clear skin at 16 weeks maintain completely clear skin through one year.

The company plans to present 2-year data from one of the studies next month at the World Congress of Dermatology in Milan, Italy. The most common adverse reactions were upper respiratory infections; which occurred in 13% of patients. Most of the reported adverse reactions were of mild or moderate severity.

This approval is an important step forward in providing people living with moderate to severe psoriasis; so with a new treatment option [that] has the potential to provide long-term relief from the signs and symptoms of psoriasis,” AbbVie vice chairman and president Michael Severino, MD, said in the release.