Patients on risankizumab also reported greater satisfaction with treatment for moderate plaque psoriasis.
New data support risankizumab (Skyrizi) as a safe and effective treatment for adults with moderate plaque psoriasis who are candidates for systemic therapy, according to an AbbVie press release, which announced the results of a phase 4 study published in the British Journal of Dermatology.
In the head-to-head IMMpulse phase 4 trial comparing risankizumab to apremilast (Otezla), risankizumab scored higher on the Psoriasis Area and Severity Index (PASI) 90 and Static Physician's Global Assessment (sPGA) 0/1, meeting the co-primary endpoints of the study.
"These head-to-head data are crucial to help patients and their doctors make informed treatment decisions for uncontrolled disease,” said Mudra Kapoor, MD, vice president, global medical affairs, immunology, AbbVie, in the press release.
During IMMpulse, a global, multicenter, randomized, open-label, efficacy assessor-blinded, active comparator study, investigators compared risankizumab, an interleukin-23 (IL-23) blocker, to apremilast for this patient population during 2 periods, consisting of Period A (weeks 0 to 16) and Period B (weeks 16 to 52).
The IL-23 blocker helped 55.9% of patients achieve PASI 90 and 75.4% achieve sPGA 0/1 at week 16. At week 52, risankizumab allowed 73.7% of patients to achieve PASI 90 compared to 4.5% among patients on apremilast. Patients on risankizumab also reported greater satisfaction (effectiveness, convenience, and global) than patients on apremilast.
The proportion of people who met the secondary endpoint, PASI 75 at week 16, was also significantly higher in the risankizumab arm compared to the apremilast arm, at 84.7% versus 18.8%, respectively. Patients on apremilast who did not achieve the secondary endpoint during Period A were able to take risankizumab during Period B, and significantly more from the risankizumab arm achieved PASI 90 compared to those who continued apremilast, at 72.3% versus 2.6%, respectively.
The drug was generally well-tolerated, and investigators observed no new safety signals. The most common adverse events (AEs) from risankizumab were upper respiratory infection and COVID-19. Other AEs include tinea infections, headache, pruritus, rash, fatigue, and reaction at the injection site.
"This study highlights the efficacy of [risankizumab] compared to [apremilast] in helping systemic-eligible patients achieve high levels of skin clearance and reinforces the safety profile observed in previous studies," Kapoor said in the press release.
Approximately 2% to 3% of people have psoriasis worldwide. It is an inflammatory skin condition that causes areas of thick, scaly skin as the result of rapid skin cell growth. The chronic condition can take a toll on emotional, psychological, and social wellbeing, and many have reported negative quality-of-life.
Risankizumab functions by binding to the p19 subunit of cytokine IL-23. IL-23 inhibition was found to decrease inflammation that leads to chronic immune-mediated diseases.
AbbVie is partnering with Boehringer Ingelheim on risankizumab, with AbbVie taking charge of global development and commercialization. Risankizumab is indicated to treat moderate to severe plaque psoriasis in adults who are candidates for systemic therapy; difficult-to-treat active psoriatic arthritis in adults (with methotrexate); and difficult-to-treat moderately to severely active Crohn disease.
"These data reinforce the efficacy of [risankizumab] for use in systemic-eligible moderate psoriasis patients with an observed safety profile similar to prior studies," said Linda Stein Gold, MD, director of clinical research, department of dermatology, Henry Ford Health System, in the press release.
SKYRIZI® (risankizumab) Achieved Superiority Versus Apremilast for Co-Primary Endpoints Among Adult Patients with Moderate Plaque Psoriasis in Phase 4 Head-to-Head Study. AbbVie. News Release. July 26, 2023. Accessed on July 27, 2023. https://news.abbvie.com/news/press-releases/skyrizi-risankizumab-achieved-superiority-versus-apremilast-for-co-primary-endpoints-among-adult-patients-with-moderate-plaque-psoriasis-in-phase-4-head-to-head-study.htm