AbbVie said Tuesday that Skyrizi (risankizumab) met both primary and all secondary endpoints in a Phase III head-to-head trial against Novartis' Cosentyx (secukinumab) in adults with moderate-to-severe plaque psoriasis. "In this study, Skyrizi showed superior efficacy compared to Cosentyx in helping patients achieve and maintain high levels of skin clearance at week 52," remarked AbbVie president Michael Severino, adding that the results add "to the growing body of evidence supporting Skyrizi as a differentiated treatment option."
The trial involves 327 patients with moderate-to-severe plaque psoriasis who are candidates for systemic therapy. Participants were randomised to receive either Skyrizi, administered as two subcutaneous injections at baseline, four weeks later and then every 12 weeks thereafter, or Cosentyx, which was given as two subcutaneous injections, at baseline, weeks one to four, and then every four weeks after that. The study assessed the percentage of patients achieving at least a 90% reduction from baseline in the Psoriasis Area and Severity Index (PASI 90), with the primary endpoints being non-inferiority at week 16 and superiority at week 52. Secondary goals were PASI 75, PASI 100 and percentage of participants with a Static Physician Global Assessment (sPGA) score of clear or almost clear, all at week 52.
AbbVie said Skyrizi was associated with significantly higher rates of skin clearance compared to Cosentyx, with 87% of patients achieving PASI 90 at week 52 compared to 57% of those on Novartis' drug. Skyrizi also met the non-inferiority endpoint, with 74% of patients achieving PASI 90 at week 16 versus 66% for Cosentyx. AbbVie also reported that Skyrizi was superior to Cosentyx for all three secondary goals.
In regards to safety, the company said Skyrizi's profile was consistent with what has been observed in other studies, with no new signals. The rate of adverse events between the two groups was comparable, while serious adverse events occurred at rates of 5.5% and 3.7% for Skyrizi and Cosentyx, respectively.
AbbVie is leading global development and commercialisation of Skyrizi under a 2016 partnership with Boehringer Ingelheim. The IL-23 antagonist brought in sales of $91 million in the third quarter of 2019, including $76 million in the US, where it was approved last April for moderate-to-severe plaque psoriasis in adults who are candidates for systemic therapy or phototherapy.
Meanwhile, Cosentyx saw sales climb 25% year-over-year to $937 million in the third quarter of last year. The IL-17a antagonist, which is approved for adults with moderate-to-severe plaque psoriasis, active psoriatic arthritis and active ankylosing spondylitis, was also topped in a head-to-head study in 2018, with Johnson & Johnson's IL-23-targeted biologic therapy Tremfya (guselkumab) showing superiority in treating adults with moderate-to-severe plaque psoriasis. More recently, Cosentyx narrowly failed to show superiority over AbbVie's Humira (adalimumab) in a late-stage psoriatic arthritis study.
For related analysis, see Physician Views Results – AbbVie's Skyrizi makes a strong early impression in psoriasis.
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