Phase III trial of Skyrizi shows two-year skin clearance rate in psoriasis

AbbVie announced new results showing a significant number of adult patients with moderate to severe psoriasis treated with Skyrizi (risankizumab) experienced complete skin clearance at week 94. In the study, at week 28 patients who achieved a static Physician Global Assessment (sPGA) score of clear or almost clear (sPGA 0/1) were re-randomized to continue treatment with Skyrizi or withdrawal. After 94 weeks of continuous treatment with Skyrizi, 73 percent and 72 percent of these patients achieved a sPGA score of clear (sPGA 0) and a 100 percent improvement in the Psoriasis Area and Severity Index (PASI 100), respectively, compared to 2 percent of patients re-randomized to withdrawal (p<0.001).

There were two phases in the IMMhance study. Results from the first phase were previously reported and showed that after 16 weeks of treatment, Skyrizi (n=407) met the co-primary endpoints of PASI 90 and sPGA 0/1 versus placebo (n=100) (p<0.001). The second phase (week 28 through week 104) evaluated the efficacy and safety of continuous therapy with Skyrizi versus randomized withdrawal, as well as re-treatment. Patients who achieved sPGA 0/1 at week 28 with Skyrizi were re-randomized to continue Skyrizi (n=111) every 12 weeks or to withdrawal (n=225). The primary endpoint from the second phase of the study, sPGA 0/1, was also met at one year (52 weeks) (p<0.001). For those re-randomized to continue Skyrizi , the last dose was given at week 88. Between one year (week 52) and week 94, the proportion of these patients who achieved complete skin clearance continued to increase. sPGA 0 and PASI 100 responses increased from 65 percent and 64 percent at week 52 to 73 percent and 72 percent at week 94, respectively (p<0.001).

At two years, 81 percent and 78 percent of patients treated with continuous Skyrizi maintained clear or almost clear skin (sPGA 0/1 or PASI 90) compared to 7 percent and 4 percent re-randomized to withdrawal, respectively (p<0.001). Among patients re-randomized to withdrawal who experienced a loss of response (defined as a sPGA score of moderate to severe [at least 3]) on or after week 32 (n=153), 84 percent regained clear or almost clear skin (sPGA 0/1) after 16 weeks of re-treatment with Skyrizi . These two-year results (up to 104 weeks) from the Phase III IMMhance study, evaluating the efficacy and safety of Skyrizi in adult patients with moderate to severe psoriasis, will be presented at the 24th World Congress of Dermatology.