Risankizumab BLA Submitted for Moderate to Severe Plaque Psoriasis

The BLA is supported by data from the global risankizumab Phase 3 psoriasis program evaluating more than 2,000 patients
The BLA is supported by data from the global risankizumab Phase 3 psoriasis program evaluating more than 2,000 patients

AbbVie announced the submission of a Biologics License Application (BLA) to the Food and Drug Administration (FDA) for risankizumab for the treatment of moderate to severe plaque psoriasis

Risankizumab, an interleukin-23 (IL-23) inhibitor, was studied in four Phase 3 trials involving over 2,000 patients with moderate to severe chronic plaque psoriasis: ultIMMa-1, ultIMMA-2, IMMhance, and IMMvent. These studies compared treatment with risankizumab to other plaque psoriasis agents such as adalimumab and ustekinumab as well as placebo. Efficacy endpoints included measures of disease activity and skin clearance (PASI 90, PASI 100, sPGA 0/1), and long-term clinical outcomes.

Across all these studies, treatment with risankizumab met all co-primary and major secondary endpoints. In addition, no new safety events were observed. In ultIMMa-1, 75% of patients receiving risankizumab for 16 weeks met the co-primary endpoint of PASI 90 vs 5% of patients receiving placebo. In ultIMMa-2, 75% of patients receiving risankizumab achieved PASI 90 vs 2% of patients receiving placebo. The response rates were also significantly higher when compared with ustekinumab PASI 90 rates of 42% in ultIMMa-1 and 48% in ultIMMa-2. 

sPGA 0/1 scores were seen in 88% and 84% of risankizumab patients in ultIMMa-1 and ultIMMa-2, respectively, vs 8% and 5% of placebo patients. Compared with ustekinumab-treated patients (63% [ultIMMa-1] and 62% [ultIMMa-2]), the response rates were also significantly greater with risankizumab. 

In IMMvent, 72% of patients treated with risankizumab achieved PASI 90 vs 47% of patients treated with adalimumab. In addition, an sPGA 0/1 score was achieved in 84% of risankziumab patients vs  60% of adalimumab patients at Week 16. In IMMhance, risankizumab met the co-primary endpoints of PASI 90 and sPGA  0/1 score vs placebo at Week 16 as well as an sPGA 0/1 score at Week 52. 

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Risankizumab is also being investigated in the treatment of Crohn's disease and psoriatic arthritis; the Company also plans to evaluate its potential role in ulcerative colitis. 

For more information call (800) 633-9110 or visit AbbVie.com.