New results presented by AbbVie show that a significant number of patients treated with Skyrizi™ (risankizumab) experienced complete skin clearance at week 94. These two-year results (up to 104 weeks) from the Phase 3 IMMhance study, evaluating the efficacy and safety of SKYRIZI in adult patients with moderate to severe psoriasis, will be presented today at the 24th World Congress of Dermatology (WCD) in Milan.
"Results show that Skyrizi has the potential to provide long-term relief from the signs and symptoms of psoriasis," says Marek Honczarenko, MD, PhD, vice president, immunology development, AbbVie. "Our studies demonstrated that Skyrizi can not only offer complete skin clearance at two years of treatment for the majority of patients, but re-treatment with Skyrizi following a relapse can help patients regain skin clearance in just 16 weeks. We are pleased to add positive long-term data to the growing body of evidence supporting the efficacy and safety profile of Skyrizi for adult patients with moderate to severe psoriasis."SKYRIZI is part of a collaboration between Boehringer Ingelheim and AbbVie, with AbbVie leading development and commercialization globally.
There were two phases in the IMMhance study. 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).
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 [≥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.
"In the IMMhance study, Skyrizi provided an increasing number of patients with complete skin clearance up to 94 weeks," said Melinda Gooderham, MD, dermatologist and medical director at the SKiN Centre for Dermatology in Peterborough, Ontario and a study investigator. "Skyrizi not only offers relief from the signs and symptoms of psoriasis following a withdrawal from medication, but the study further demonstrates the significant rates of complete skin clearance that can be achieved with continuous treatment at the recommended dose. These data underscore the lasting impact this new treatment option could provide for people living with psoriasis."
No new safety findings were observed in patients who continued with Skyrizi for two years compared with those who withdrew to placebo at week 28.1 Rates of treatment-emergent adverse events were similar to placebo at week 16 and remained stable over time in patients treated with Skyrizi.