FDA Approves Risankizumab for Plaque Psoriasis

The US Food and Drug Administration (FDA) has approved risankizumab-rzaa (Skyrizi) for the treatment of moderate to severe plaque psoriasis in adults who are candidates for systemic therapy or phototherapy.

The recommended treatment with risankizumab begins with 2 initial doses totaling 150 mg given at week 0 and again at week 4, followed by 150 mg via 2 injections every 12 weeks thereafter.

"The approval of SKYRIZI is an important advance in the treatment of adults with plaque psoriasis who are seeking high levels of durable skin clearance that can be maintained over time," said Michael Severino, MD, vice chairman and president, AbbVie.

The FDA’s approval decision was supported by positive results from 4 phase 3 trials of risankizumab compared to placebo or active control: ultIMMa-1, ultIMMa-2, IMMhance and IMMvent.

In ultIMMa-1 and ultIMMa-2, 75% of patients treated with risankizumab reached 90% skin clearance (PASI 90) at week 16, compared to 5% and 2% of patients receiving placebo, respectively (P <.001). Additionally, PASI 100 was reached by 36% and 51% of patients treated with risankizumab compared to 0% and 2% of those receiving placebo.

At one year, in ultIMMa-1 and ultIMMa-2, 82% and 81% of those treated with risankizumab reached PASI 90, and 56% and 60% achieved PASI 100 (P <.001).

Kenneth B. Gordon, MD, a principal investigator for the ultIMMa-1 pivotal trial and professor and chair of dermatology at the Medical College of Wisconsin spoke with MD Magazine® about the ultIMMa trials at the 2019 Annual Meeting of the American Academy of Dermatology (AAD) in Washington, DC.

Gordon shared that an important result was the persistence of effect seen in treatment with risankizumab compared to ustekinumab.

“When you look at dosing intervals, especially at the higher-level responses, you begin to see a little inconsistency in the ustekinumab response, which actually shows up in the clinic, where people are beginning to have little recurrences at the end of the dosing period that doesn't seem to happen with the risankizumab—it's a much more stable outcome,” said Gordon.

The most common adverse events associated with risankizumab treatment were upper respiratory infections (13%), headache (3.5%), fatigue (2.5%), injection site reactions (1.5%), and tinea infections (1.1%).

"In clinical trials, risankizumab demonstrated high levels of skin clearance that persisted through one year,” said Gordon in a statement. “I'm pleased the dermatology community now has a new option that can help patients achieve and maintain a high level of treatment response."

Ongoing phase 3 trials are evaluating risankizumab for Crohn’s disease and psoriatic arthritis, and it is also being studied in ulcerative colitis.