Results from Skyrizi phase III IMMvent study in moderate to severe plaque psoriasis published in The Lancet

AbbVie has announced the publication of positive results from the pivotal Phase III IMMvent clinical study in The Lancet.

The study evaluates the safety and efficacy of Skyrizi (risankizumab) up to 44 weeks compared to adalimumab in adult patients with moderate to severe chronic plaque psoriasis. Risankizumab met the co-primary endpoints of at least a 90 percent improvement in the Psoriasis Area and Severity Index (PASI 90) and a static Physician Global Assessment (sPGA) score of clear or almost clear (0/1) versus adalimumab at weeks 16 and 44 (p<0.0001). At week 16, 72 percent of patients receiving risankizumab (n=301) at the label dose achieved PASI 90 compared to 47 percent of patients treated with adalimumab (n=304) at the label dose. 84 percent of risankizumab-treated patients achieved a sPGA score of clear or almost clear (0/1) compared to 60 percent of patients receiving adalimumab. Additionally, 40 percent and 41 percent of patients treated with risankizumab achieved complete skin clearance (defined as PASI 100 and sPGA 0, respectively) at week 16 compared to 23 percent of patients treated with adalimumab (for both measures of skin clearance).

In the second phase (week 16 to week 44) of IMMvent, patients receiving adalimumab who achieved a response of at least PASI 50 but less than PASI 90 at week 16 (intermediate responders) were re-randomised to either switch to risankizumab (n=53) or continue adalimumab (n=56). Of these patients, those re-randomised to risankizumab saw significantly greater response rates. 66 percent achieved PASI 90 at week 44 when switched to risankizumab, compared to 21 percent of patients who continued on adalimumab (p<0.001). Additionally, 40 percent of patients who switched to risankizumab achieved complete skin clearance (PASI 100 or sPGA 0) at week 44 compared to 7 percent of patients who continued treatment with adalimumab (for both measures of skin clearance).

All the patients who switched to risankizumab at week 16 started at the initial label dose schedule. Risankizumab is part of a collaboration between Boehringer Ingelheim and AbbVie, with AbbVie leading development and commercialisation globally.

See- Reich, K., "Efficacy and Safety of Risankizumab Compared with Adalimumab in Patients with Moderate-to-Severe Plaque Psoriasis: Results from a Randomized, Double-blind, Active-comparator, Controlled Phase III Trial (IMMvent). The Lancet. 2019.