On February 17th, Phase III head to head clinical trial data assessing the use of AbbVie’s risankizumab in comparison with J&J’s Stelara (ustekinumab) in adult patients with moderate-to-severe chronic plaque psoriasis (PsO) was presented at the 76th Annual American Academy of Dermatology (AAD) meeting. Risankizumab is a humanised IgG1 monoclonal antibody that binds to the p19 subunit of interleukin 23 (IL-23), which is involved in the pathophysiology of numerous chronic inflammatory diseases, including PsO and psoriatic arthritis. Although risankumab missed the first-to-market advantage for the IL-23 inhibitors in the PsO space, if approved, it has the potential to be prescribed over Stelara based on its superior efficacy profile.
In Phase III replicate, randomised, double-blind, placebo and active comparator controlled UltlMMa 1 (n=506) and UltlMMa 2 (n=491) trials, patients were randomised (3:1:1) to receive 150mg of risankizumab, 45/90mg of Stelara (weight-based per label), or placebo at Weeks 0, 4, 16, 28, and 40, with placebo crossover to risankizumab at Week 16. The co-primary endpoints were at least a 90% reduction in Psoriasis Severity Index Score (PASI 90) and Static Physicians Global Assessment of 0 or 1 (sPGA 0/1) at Week 16 versus placebo with comparisons between risankizumab and Stelara as ranked secondary endpoints.
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At Week 16, patients receiving risankizumab in the UltlMMa 1 and UltlMMa 2 trials achieved significantly higher PASI 90 (75.3%/74.8%) and sPGA 0/1 scores (87.8%/83.7%) response rates compared with placebo (4.9%/2.0%; 7.8%/5.1%) as well as compared with Stelara (42.0%/47.5%; 63.0%/61.6%). In addition, patients treated with risankizumab demonstrated significantly higher response rates than Stelara at Week 52. Most notably, patients treated with risankizumab boosted a 56.3% and 59.5% PASI 100 response rate at Week 52 in the UltlMMa 1 and UltlMMa 2 trials, respectively, compared with 21.0% and 30.3% of patients treated with Stelara, marking a significant achievement for AbbVie.
Focusing on the competition in the PsO market, J&J’s IL-23 inhibitor Tremfya (guselkumab) received FDA and EMA approval in July 2017 and November 2017, respectively. In addition, Sun Pharma has filed for FDA and EMA approval for their IL-23 inhibitor tildrakizumab. If approved, risankizumab will have to compete against two other marketed IL-23 inhibitors in a disease space already overcrowded with biologics, marking a substantial challenge for AbbVie.
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