PARIS — For patients with moderate to severe psoriasis, risankizumab (ABBV-066, AbbVie), a novel biologic, is significantly better than placebo, an integrated analysis of three phase 3 trials shows.
"Regardless of body weight, sex, initial Psoriasis Area Severity Index [PASI] score, or anything else, you're going to get high responses from this particular drug," said investigator Charles Lynde, MD, from the University of Toronto.
Risankizumab is one of a small group of monoclonal antibodies that targets interleukin (IL)-23. The drug binds to the IL-23 p19 subunit and interferes with its ability to activate and maintain psoriatic lesions.
"The IL-23s are coming," Lynde said here at the 27th European Academy of Dermatology and Venereology Congress. Guselkumab (Tremfya, Janssen) targets IL-23 in the same way, and tildrakizumab (Ilumya, Sun Pharmaceuticals) is approved for some patients with psoriasis.
For their analysis, Lynde and his colleagues integrated data from the 16-week placebo-controlled period of three trials of risankizumab for moderate to severe plaque psoriasis: UltiMMa-1 (NCT02684370) and UltiMMa-2 (NCT02684357) and IMMhance (NCT02672852).
Overall, the baseline demographic characteristics were similar for the 1305 patients in the treatment and placebo groups. Average age was 48.1 years. Patients were matched by weight and exposure to tumor necrosis factor inhibitors at randomization, and 1005 were assigned to receive risankizumab 150 mg at weeks 0 and 4 and 300 were assigned to placebo.
Significantly more patients treated with risankizumab than with placebo achieved a reduction in PASI score of at least 90% (74.3% vs 3.0%; P < .001), and significantly more patients in the risankizumab group achieved a static Physician's Global Assessment score of 0 or 1 (84.9% vs 6.7%; P < .001).
"This reinforces the spectacular results we've seen in the phase 1 and 2 trials," said investigator Mark Lebwohl, MD, from the Icahn School of Medicine at Mount Sinai in New York City. "What we're seeing is PASI 90 rates, for the first time, of this magnitude with a drug given at 3-month intervals."
"Also, the body surface was quite high and a large percentage of the patients were obese," Lebwohl told Medscape Medical News. Average weight was in excess of 90.8 kg (200 pounds).
"Historically, people who weigh more and who have failed multiple other drugs have done less well. This drug worked well in every subgroup," he said.
Among the demographic characteristics tested were body mass index, smoking status, age, race (white or other), sex, and location of residence.
Another benefit of risankizumab is its dosing interval, at once every 3 months. In contrast, it is weekly for etanercept (Enbrel, Amgen), every other week for adalimumab (Humira, AbbVie), monthly for certolizumab pegol (Cimzia, UCB), and every other month for guselkumab.
Crowded Treatment Landscape
But the longer dosing interval and strong response rates might not be enough to make risankizumab an obvious choice in a crowded treatment landscape, said Brett King, MD, from the Yale University School of Medicine in New Haven, Connecticut.
"The data look great, as they do for the class of IL-23 inhibitors in general," he told Medscape Medical News. But when risankizumab is compared with guselkumab, "both dosing schedules are easy, so I don't know that this will figure prominently in dermatologists' minds or make a difference to patients."
Risankizumab appears to have a very durable response. If you stop it and wait, it takes a long time for the disease to come back, Lebwohl explained.
It is expected that the drug will be on the market in the United States in 2019, and sometime in the next 2 years in Canada and Europe, Lynde reported.
The UltiMMa-1, UltiMMa-2, and IMMhance studies were funded AbbVie and Boehringer Ingelheim. Lynde reports financial relationships with AbbVie, Amgen, Boehringer Ingelheim, Eli Lilly, Janssen, Merck, Novartis, and Valeant. Lebwohl reports financial relationships with AbbVie, Allergan, Aqua, Boehringer Ingelheim, LEO Pharma, Menlo, and Promius, and is an employee of Mount Sinai, which receives research funds from AbbVie, Boehringer Ingelheim, Celgene, Eli Lilly, Incyte, Janssen, Johnson and Johnson, Leo Pharmaceuticals, MedImmune/AstraZeneca, Novartis, Pfizer, Sciderm, UCB, Valeant, and ViDac. King has disclosed no relevant financial relationships.
27th European Academy of Dermatology and Venereology (EADV) Congress: Abstract OP01.04. Presented September 13, 2018.
Medscape Medical News © 2018 WebMD, LLC
Send comments and news tips to firstname.lastname@example.org.
Cite this: Risankizumab Effective for Moderate to Severe Psoriasis - Medscape - Sep 14, 2018.