Phase 3 Results Show Further Efficacy of Novel Plaque Psoriasis Tx
The investigational compound, risankizumab (150mg; AbbVie), has demonstrated further positive results in treating moderate to severe plaque psoriasis in a fourth pivotal Phase 3 trial.
AbbVie announced that the IMMhance study met both its co-primary endpoints of ≥90% improvement in Psoriasis and Severity Index (PASI 90) and a static Physician Global Assessment (sPGA) score of clear or almost clear (sPGA 0/1) vs placebo.
The study composed of 2 phases. The first phase randomized patients 4:1 to receive risankizumab 150mg SC at baseline, Week 4 and every 12 weeks thereafter, or placebo for 16 weeks. The second phase re-randomized risankizumab-treated patients to risankizumab or placebo from Week 28 through 104 to assess for continued maintenance therapy vs randomized withdrawal.
At Week 16, 73% of risankizumab patients achieved PSAI 90 vs 2% of placebo patients, and sPGA 0/1 was reached by 84% in the risankizumab arm vs 7% in the placebo arm (P<0.001 for both). The second phase of the study is ongoing but at Week 52, the primary endpoint was met showing that 87% of patients on continued risankizumab therapy maintained sPGA 0/1 at one year vs 61% in the withdrawal group (P<0.001).
The safety profile in the IMMhance study was consistent with previously reported Phase 3 trials, with no new safety concerns reported for risankizumab.
Risankizumab is designed to selectively block IL-23 by binding to its p19 subunit. The global risankizumab Phase 3 program includes over 2,000 plaque psoriasis patients from the IMMhance, ultIMMa-1, ultIMMa-2, and IMMvent clinical trials.
For more information Abbvie.com.