Risankizumab demonstrates efficacy, safety in phase 3 plaque psoriasis trial
Risankizumab was well tolerated during a phase 3 study that found the drug had better efficacy than placebo at 16 weeks and treatment withdrawal at 2 years in patients with moderate to severe plaque psoriasis, according to a study published in JAMA Dermatology.
“This is the final phase 3 study that was done for FDA approval of risankizumab for psoriasis,” Andrew Blauvelt, MD, MBA, of Oregon Medical Research Center, told Healio. “Compared to the other three, it is the only randomized withdrawal trial for risankizumab and is the longest study reported to date for risankizumab, with efficacy and safety documented over 2 years of continuous use in the patients who are never withdrawn from the drug.”
In the double-blind, placebo-controlled clinical trial, 507 patients were randomly assigned to receive either risankizumab 150 mg subcutaneously (407 patients) or placebo (100 patients) at week 0 and week 4. At week 16, 73.2% of patients in the risankizumab group vs. 2% of patients in the placebo group had a 90% improvement in Psoriasis Area and Severity Index (PASI) score, and 83.5% of patients in the treatment group vs. 7% of patients in the placebo group had a static Physician’s Global Assessment (sPGA) score of 0/1.
Starting at week 28, 336 treatment responders were randomly assigned again, 111 to risankizumab and 225 to treatment withdrawal.
Final follow-up at week 104 yielded an sPGA score of 0/1 in 81.1% of risankizumab patients vs. 7.1% of placebo patients.
“Compared to other randomized withdrawal trials with other psoriasis biologics, risankizumab demonstrates the longest durable clinical effects,” Blauvelt said.
Further, patients who stayed on risankizumab for the entirety of the trial achieved high levels of durable efficacy, with more than 80% achieving PASI 90 and more than 60% achieving PASI 100, according to Blauvelt.
“The three main pillars of a good psoriasis drug for my patients are efficacy, safety and convenience. Risankizumab is highly efficacious, very safe and convenient, making it an excellent choice for patients with psoriasis who require biologic therapy,” Blauvelt said. – by Kate Burba
Disclosures: Blauvelt reports he has served as a scientific adviser and/or clinical study investigator for AbbVie, Aclaris, Almirall, Arena, Athenex, Boehringer Ingelheim, Bristol-Myers, Squibb, Dermavant, Dermira, Eli Lilly and Company, FLX Bio, Forte, Galderma, Janssen, Leo, Novartis, Ortho, Pfizer, Regeneron, Sandoz, Sanofi Genzyme, Sun Pharma and UCB Pharma and as a paid speaker for AbbVie. Please see the study for all other authors’ relevant financial disclosures.