Disclosure: The European Medical Journal has engaged in business transactions with Abbvie.
POSITIVE results from a Phase III study investigating a potential new treatment for psoriasis were presented by Abbvie (Illinois, USA) at the Psoriasis from Gene to Clinic International Congress, which took place in London, UK, from 30th November–2nd December 2017. In the ongoing study, the drug risankizumab has met all co-primary and ranked secondary endpoints, with no new safety signals found.
Results
The fourth pivotal Phase III trial, named IMMhance, for patients with moderate-to-severe plaque psoriasis, included two phases. In the first, up to Week 16, the co-primary endpoints of at least 90% improvement in Psoriasis and Severity Index (PASI) score and 0/1 Physician Global Assessment (sPGA) score versus placebo (p<0.001). At this stage, 73% and 84% of patients receiving risankizumab achieved PASI 90 and sPGA 0/1 scores compared with 2% and 7% of those receiving placebo, respectively. Additionally, a PASI 100 score was seen in 47% of risankizumab-treated patients compared with 1% of patients receiving placebo, and the rate of patients achieving an sPGA of 0 was 46% versus 1% in patients treated with risankizumab and placebo, respectively.
In the second phase, from Week 28–104, patients treated with risankizumab who achieved sPGA 0/1 at Week 28 were re-randomised to either be maintained on the same treatment, or put on placebo. Those who experienced a relapse from Week 32 onwards (sPGA >3) were retreated with risankizumab immediately, 4 weeks later, and every 12 weeks thereafter. Among patients maintained on risankizumab, 87% achieved the primary endpoint of sPGA 0/1 at 1 year compared with 61% of those in the withdrawal group. The safety profile was consistent with previously reported Phase III clinical trials.
Regulatory Approval
“With a significant portion of risankizumab patients achieving high levels of skin clearance, these results add to the data supporting risankizumab’s potential to be an impactful new treatment option for patients living with psoriasis,” commented Dr Michael Severino, Executive Vice President, Research and Development and Chief Scientific Officer, Abbvie. “We look forward to sharing additional data from the pivotal trial programme with the scientific community and regulatory authorities as we prepare to move forward with global regulatory submissions.”
James Coker, Senior Editorial Assistant
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