PracticeUpdate Conference Series World Congress of Dermatology 2019

Two-Year Study Confirms Long-Term Benefits of Risankizumab in Psoriasis Over time, patients on risankizumabmaintained clear skin or had increased clearing. R isankizumab provides a durable response for psoriasis in a trial that followed patients on continuous therapy for up to 104 weeks, findings presented at WCD 2019 reveal. weeks of risankizumab re-treatment, 83.7% of these patients regained sPGA 0/1. Risankizumab was well-tolerated. Safety was generally compa- rable in the continuous-therapy and the placebo groups.

Risankizumab is a humanized IgG1 monoclonal antibody that selectively inhibits interleukin (IL)-23 through binding p19. It was recently FDA-approved in the United States for use in psoriasis. It is also approved by the European Medicines Agency for this indication. “Targeting p19 has shown higher levels of efficacy [in psoriasis], as high or higher than biologics that have already been on the market,” study coauthor Melinda Gooderham, MD, of Queen’s University School of Medicine in Kingston, Canada, told Elsevier’s PracticeUpdate . “The nice thing is that, with the higher levels of efficacy, you don’t compromise safety. You have a clean safety profile. There are no new concerns. If anything, there are fewer safety concerns than we see with the current biologics on the market.” IMMhance was a two-part, phase III, multinational, double-blind study in patients with moderate-to-severe plaque psoriasis. In the first part of the study, after 16 weeks of treatment, a greater pro- portion of the 407 patients treated with 150 mg of risankizumab met the coprimary endpoints of Psoriasis Area and Severity Index (PASI) 90 and static Physician’s Global Assessment (sPGA) 0/1, compared with the 100 patients on placebo (P < .001). In the second part of the trial, led by Andrew Blauvelt, MD, of the Oregon Medical Research Center in Portland, responders to initial risankizumab treatment (defined as an sPGA 0/1) at week 28 were stratified by weight and prior TNF inhibitor exposure and then re-randomized in a 1:2 fashion to continuous risanki- zumab every 12 weeks (n=111) or to placebo (n=225). After week 32, patients who relapsed, as defined by an sPGA ≥3, were re-treated with open-label risankizumab 150 mg. The primary and ranked secondary efficacy endpoints were the proportion of patients who maintained sPGA 0/1 at weeks 52 and 104, respectively, using non-responder imputation. Safety was also assessed in all patients. At week 52, 87.4% of patients re-randomized to continuous risankizumab maintained sPGA 0/1, and 81.1% maintained it at week 104. In contrast, sPGA 0/1 was maintained in 61.3% of pla- cebo at 52 weeks and 7.1% at 104 weeks (P < .001 for both time comparisons). By week 94, 73% of patients receiving continuous risankizumab had completely clear skin, defined as an sPGA 0. “That’s the highest level of sPGA 0 we have seen with any biologic,” said Dr. Gooderham. “Usually, we see a bit of a drop-off as you lose efficacy in some patients over time, but we did not see that with this medication. We saw the levels increasing, with more patients becoming clear the longer they were being treated. … [And] we know from many other studies that patients with [completely] clear skin have a better quality of life.” Overall, 153 of the 225 responders at week 28 who were re-randomized to placebo experienced relapse (68%). After 16

“This is a chronic condition, … a disease that people suffer with for decades,” said Dr. Gooderham. “If week 16 results look great, but in 2 years they are losing response, that is not helping us out in the long run. So, with therapy where we see patients staying clear and more patients becoming clear over time, we can be sure their chronic disease will be controlled chronically. … We shouldn’t have any tolerance for psoriasis hanging around now that we know we can clear it with such high levels.” " We shouldn’t have any tolerance for psoriasis hanging around now that we know we can clear it with such high levels. " www.practiceupdate.com/c/85591

© WCD 2019

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PRACTICEUPDATE CONFERENCE SERIES • WCD 2019