AbbVie builds case for potential psoriasis blockbuster risankizumab ahead of regulatory decisions

AbbVie has posted an analysis of patient-reported outcomes from phase 3 trials of risankizumab. The analysis builds out the evidence in support of the IL-23 antibody ahead of anticipated approvals that will clear it to duke it out for the psoriasis market.

Risankizumab came through the phase 3 trials last year, giving AbbVie the data to file for approval on both sides of the Atlantic. With risankizumab working its way through the regulatory process, AbbVie has continued sifting through the data in search of nuggets that will help differentiate the drug from established and emerging rivals sold by Eli Lilly, Johnson & Johnson and other companies.

The analysis focused on patient-reported outcomes gathered across three phase 3 trials that pitted risankizumab against J&J’s Stelara and AbbVie’s own Humira. A pooled analysis of data from the two Stelara trials found that significantly more patients who received risankizumab reported being free from pain, redness and other symptoms of psoriasis. After one year, 56% of patients in the risankizumab arm were symptom-free, compared to 30% in the Stelara cohort.

AbbVie also saw a statistically significant divergence in patient-reported measures of anxiety and depression. After 16 weeks, patients who received risankizumab reported declines in anxiety and depression of 3 points and 2.7 points, respectively, on the 21-point self-assessment scale. Patients in the Stelara group reported improvements, too, but they fell short of those seen in the risankizumab group.

The other analyses come from the phase 3 trial that compared risankizumab to AbbVie’s stalwart Humira. These analyses linked risankizumab to statistically significant improvements in measures of quality of life and the extent to which health problems interfere with the ability to work.

AbbVie’s patient-reported outcomes cement the impression that risankizumab is more effective at treating psoriasis than Stelara and Humira. The bigger, unanswered question is whether risankizumab is more effective than more recently approved therapies such as J&J's Tremfya, the only approved IL-23 drug, and Lilly’s IL-17 antibody Taltz. Cross-trial comparisons of the drugs suggest that risankizumab holds it own, at the very least, and it has a less-onerous dosing schedule on its side, too. 

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