The AbbVie investigational drug hit endpoints in 3 pivotal phase 3 trials.
Risankizumab, an investigational therapy for patients with moderate to severe chronic plaque psoriasis, proved strong efficacy versus standard biologic therapies such as ustekinumab (STELARA) and adalimumab (HUMIRA).
The interleukin-23 (IL-23) inhibitor from AbbVie and Boehringer Ingelheim reached all primary and secondary endpoints of 3 pivotal phase 3 trials in its investigation as a possible plaque psoriasis therapy.
Two of the clinical trials were replicate (ultlMMa-1 and ultlMMa 2) and compared safety and efficacy of risankizumab 150 mg to either placebo or STELARA — either 45 mg or 90 mg, depending on patient weight. After 16 weeks of treatment, 75% of risankizumab patients in both studies achieved at least 90% Psoriasis Area and Severity Index improvement (PASI 90), versus the rates of 5% or less in the trials’ placebo groups, and rates of 48% or less in the trials’ STELARA groups.
Complete skin clearance (PASI 100) was met in twice as many risankizumab patients at week 16 and year 1 as in STELARA. The risankuzumab 150 mg patient groups similarly scored better than the other 2 therapy groups in static Physician Global Assessment (sPGA). Michael Severino, MD, executive vice president of AbbVie’s research and development, and chief scientific officer, said he was encouraged by the results in an AbbVie statement.
“What is particularly exciting is the number of patients who achieved high rates of skin clearance in these three head-to-head clinical trials,” Severino said. “Risankizumab has the potential to provide a meaningful new treatment option for people living with psoriasis.”
Kenneth B. Gordon, MD, principal investigator of the ultIMMA-1 study, said in the same statement that skin clearance is an “important goal of treatment and remains an unmet need for many of our patients who suffer from psoriasis.”
AbbVie declined to comment to MD Magazine.
Risankizumab’s compound works by selectively blocking the IL-23 by binding to its p19 subunit, thereby limiting the cytokine’s involvement in inflammatory processes.
Though the investigational drug has not been approved by any regulatory authorities yet, it has ongoing trials for its treatment of psoriasis, Crohn’s disease, and psoriatic arthritis, as well as a planned trial for ulcerative colitis.
A press release regarding the study was made available.