Plaque Psoriasis trial results announced

AbbVie announced positive top-line results from IMMhance, the fourth pivotal Phase III clinical trial evaluating ABBV 066 risankizumab (150 mg) for the treatment of patients with moderate to severe plaque psoriasis. There were two phases in this study. Results from the first phase showed that after 16 weeks of treatment, risankizumab met the co-primary endpoints of at least a 90 percent improvement in the Psoriasis and Severity Index (PASI 90) and a static Physician Global Assessment (sPGA) score of clear or almost clear (sPGA 0/1) versus placebo. In the second phase of this study, the primary endpoint of sPGA 0/1 at week 52 (one year) was also met.

The second phase (week 28 through 104) is evaluating the efficacy and safety of continuous therapy with risankizumab versus randomized withdrawal. Subsequently, retreatment is also being evaluated in this ongoing study. Risankizumab is not approved by regulatory authorities and its safety and efficacy have not been established. At week 16, results from the IMMhance study showed that 73 percent of patients receiving risankizumab achieved PASI 90 compared to 2 percent of patients receiving placebo. An sPGA 0/1 was achieved by 84 percent of risankizumab patients compared to 7 percent of placebo patients. Results showed that nearly half (47 percent) of patients receiving risankizumab achieved PASI 100 compared to 1 percent of patients receiving placebo.

Additionally, 46 percent of patients receiving risankizumab achieved an sPGA 0 compared to 1 percent of patients receiving placebo. Results from IMMhance through week 16 were presented during an oral presentation at the 8th International Congress of Psoriasis from Gene to Clinic meeting.