FDA Approves New Therapy for Moderate to Severe Plaque Psoriasis

Officials with the FDA have approved risankizumab-rzaa (Skyrizi, AbbVie) for the treatment of moderate-to-severe plaque psoriasis, according to a press release. The treatment is indicated for adults who are candidates for systemic therapy or phototherapy.

The recommended dose of risankizumab-rzaa is 150 mg, administered by 2 subcutaneous injections every 12 weeks following 2 initiation doses at weeks 0 and 4, according to AbbVie. The treatment can be administered in-office or by self-injection after training.

Risankizumab-rzaa, an interleukin-23 (IL-23) inhibitor, selectively blocks IL-23 by binding to its p19 subunit. IL-23 is thought to be linked to a number of chronic immune-mediated diseases, including psoriasis, which is the most prevalent autoimmune disease in the United States.

This approval is based on data from AbbVie’s phase 3 psoriasis clinical trial program, which evaluated the safety and efficacy of risankizumab-rzaa in adults with moderate-to-severe plaque psoriasis across 4 studies: ultIMMa-1, ultIMMa-2, IMMhance, and IMMvent. According to the study, patients treated with risankizumab-rzaa every 12 weeks achieved high levels of durable skin clearance at 16 weeks and maintained this response at 1 year.

Key findings from the trials showed:

• Psoriasis Area and Severity Index (PASI 90) was achieved in 75% of patients treated with risankizumab-rzaa, compared with 5% and 2% receiving placebo, respectively (p<0.0001), in ultIMMa-1 and ultIMMa-2 at 16 weeks. PASI 100 was achieved in 36% and 51% of patients treated with risankizumab-rzaa, compared with 0% and 2% receiving placebo, respectively.
• At 1 year in ultIMMa-1 and ultIMMa-2, 82% and 81% of patients treated with risankizumab-rzaa achieved PASI 90, respectively, and 56% and 60% achieved PASI 100, respectively (p<0.0001).
• In ultIMMa-1 and ultIMMa-2, most patients treated with risankizumab-rzaa who achieved PASI 90 and PASI 100 at week 16 maintained this response at 1 year (88% and 80%, respectively).

The most common adverse events (AEs) reported that were associated with risankizumab-rzaa included upper respiratory infections, headache, fatigue, injection site reactions, and tinea infections. Overall, the frequency of AEs through 1 year was similar to events seen in the first 16 weeks. Because of the increased risk of infections, patients starting treatment with risankizumab-rzaa must receive an initial evaluation for tuberculosis prior to therapy initiation.

“The complex nature of psoriasis and the variability or loss of treatment response over time can prevent some patients from achieving their treatment goals,” Kenneth B. Gordon, MD, principal investigator for the ultIMMa-1 trial and professor and chair of dermatology at the Medical College of Wisconsin, said in a statement. “In clinical trials, risankizumab demonstrated high levels of skin clearance that persisted through 1 year. I’m pleased the dermatology community now has a new option that can help patients achieve and maintain a high level of treatment response.”

AbbVie said that it expects risankizumab-rzaa to be available in the United States in early May, according to the release. Risankizumab-rzaa is also being investigated for use in Crohn disease, psoriatic arthritis, and ulcerative colitis.

Reference

AbbVie Expands Immunology Portfolio in the US with FDA Approval of SKYRIZI (risankizumab-rzaa) for Moderate to Severe Plaque Psoriasis [news release]. AbbVie. https://news.abbvie.com/news/press-releases/abbvie-expands-immunology-portfolio-in-us-with-fda-approval-skyrizi-risankizumab-rzaa-for-moderate-to-severe-plaque-psoriasis.htm. Accessed April 24, 2019.