AbbVie’s Risankizumab-rzaa Granted Regulatory Approval

April 24, 2019

Indicated for adults with moderate to severe plaque psoriasis.

Risankizumab-rzaa (SKYRIZI) is an interleukin-12 (IL-23) inhibitor, indicated for the treatment of moderate to severe plaque psoriasis in adults who are also candidates for systemic therapy or phototherapy. Prior to treatment, patients must be screened for tuberculosis and other infections.

"The complex nature of psoriasis and the variability or loss of treatment response over time can prevent some patients from achieving their treatment goals," said 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. "In clinical trials, risankizumab demonstrated high levels of skin clearance that persisted through one 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."

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In clinical trials, risankizumab-rzaa produced high rates of skin clearance - over 80% of people treated with risankizumab-rzaa achieved 90% skin clearance within one year, whereas the majority (56-60%) achieved complete skin clearance. 

Recommended dosage of risankizumab-rzaa is 150 mg, administered by two subcutaneous injections every 12 weeks following two initiation doses at weeks zero and four. 

"The eagerly anticipated approval of risankizumab (SKYRIZI), a selective IL-23 blocker, for the treatment of adults with moderate to severe plaque psoriasis provides dermatology with a new treatment option with tremendous efficacy and excellent safety," says Dr. George Martin, MD, a member of the Medical Board of the National Psoriasis Foundation. "Over half of the patients studied achieved 100% skin clearance. After an initiation dose of 150 mg (two 75 mg injections) at week 0 and 4, the maintenance dosing schedule of 150 mg dosing every 3 months also offers a level of convenience sought by many patients.   Although not specifically approved for the treatment of generalized pustular psoriasis and erythrodermic psoriasis, risankizumab has also demonstrated efficacy in these patients and is approved in Japan for these two indications. Risankizumab is currently being studied in phase 3 clinical trials for the treatment of psoriatic arthritis."

The most common adverse events reported in clinical trials included upper respiratory infections, headache, fatigue, injection site reactions, and tinea infections. 

Psoriasis currently affects more than 8 million Americans, and 125 million people worldwide. About 30% of those that develop psoriasis will also develop psoriatic arthritis at some point in their life. 

 

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