The European Commission ( EC ) has approved Skyrizi ( Risankizumab ) for the treatment of moderate to severe plaque psoriasis in adult patients who are candidates for systemic therapy.
Skyrizi ( 150 mg ) is approved to be administered by two subcutaneous injections every 12 weeks following two initiation doses at week 0 and week 4.
In clinical studies, Skyrizi has demonstrated high rates of skin clearance at 16 weeks and this clearance was durable at one year ( 52 weeks ).
Skyrizi has received EC approval based on results from four pivotal phase 3 studies, ultIMMa-1, ultIMMa-2, IMMvent and IMMhance evaluating more than 2,000 patients with moderate to severe plaque psoriasis.
Across all four studies, the co-primary endpoints were at least a 90% improvement in the Psoriasis Area and Severity Index ( PASI 90 ) and a static Physician Global Assessment ( sPGA ) score of clear or almost clear ( sPGA 0/1 ) at week 16.
In the ultIMMa-1 and ultIMMa-2 studies, Skyrizi met the co-primary endpoints of sPGA 0/1 and PASI 90 at week 16 ( p less than 0.001 ).
After 16 weeks of treatment, 88% ( ultIMMa-1 ) and 84% ( ultIMMa-2 ) of Skyrizi patients achieved sPGA 0/1 and 75% of patients receiving Skyrizi in both studies achieved PASI 90.
An integrated analysis of patients who received Skyrizi in the ultIMMa-1 and ultIMMa-2 studies showed that, of patients who achieved PASI 90 with Skyrizi at week 16, 88% of these patients maintained PASI 90 with Skyrizi at one year ( 52 weeks ).
Of patients who achieved PASI 100 with Skyrizi at week 16, 80% maintained PASI 100 with Skyrizi at one year ( 52 weeks ).
Skyrizi demonstrated superiority versus Adalimumab ( Humira ) in the IMMvent study, with 72% of patients achieving PASI 90 compared to 47% of patients treated with Adalimumab at week 16 ( p less than 0.001 ).
Following re-randomization at week 16, 66% of patients who started on Adalimumab and switched to Skyrizi achieved PASI 90, compared to 21% who continued on Adalimumab at week 44 (p less than 0.001 ).
The co-primary endpoints of sPGA 0/1 and PASI 90 at week 16 were met ( p less than 0.001 ).
Results from IMMhance showed that, among people receiving Skyrizi who achieved clear or almost clear skin ( sPGA 0/1 ) response at week 28 and were re-randomized to continue Skyrizi ( n=111 ), 87% maintained this response at week 52 compared to 61% re-randomized to withdraw ( n=225 ).
The co-primary endpoints of sPGA 0/1 at week 16 and week 52 were met ( p less than 0.001 ).
Skyriz was also reported to improve health-related quality of life in phase 3 studies. In ultIMMa-1 and ultIMMa-2, significantly more patients treated with Skyriz self-reported a DLQI ( Dermatology Life Quality Index ) score of 0 or 1 ( 75% in ultIMMa-1 and 71% in ultIMMa-2 ) compared with Ustekinumab ( 47% in ultIMMa-1 and 44% in ultIMMa-2 ) at one year ( p less than 0.001 ).
The most frequently reported adverse reactions were upper respiratory infections, which occurred in 13% of patients.
Common adverse reactions ( frequency defined as greater than or equal to 1/100 events to less than 1/10 ) included tinea infections, headache, pruritus, fatigue and injection site reactions. ( Xagena )
Source: Abbvie, 2019