%0 Journal Article %T Real-world Safety and Efficacy of Risankizumab in Psoriatic Patients: A Multicenter, Retrospective, and Not-interventional Study. %A Martorell A %A Santos-Alarcón S %A Sahuquillo-Torralba A %A Rivera-Díaz R %A Belinchón-Romero I %A Ruiz-Genao D %A Romero-Maté A %A Ruiz-Villaverde R %A Ferran-Farrés M %A Gallardo-Hernández F %A Almenara-Blasco M %A Suarez-Perez JA %A González-Cantero Á %A Martínez-Lorenzo E %A Fernández-Armenteros JM %A Del Alcázar-Viladomiu E %A García-Latasa J %A Rocamora-Durant V %A Ara-Martín M %A Mateu-Puchades A %A Llamas-Velasco M %A Vilarrasa E %A Velasco-Pastor M %A De la Cueva P %A Carrascosa JM %A Magdaleno-Tapial J %J Actas Dermosifiliogr %V 0 %N 0 %D 2024 Mar 6 %M 38452889 暂无%R 10.1016/j.ad.2024.02.030 %X OBJECTIVE: Risankizumab - a humanized monoclonal antibody that targets the p19 subunit of IL-23 - has been recently approved to treat moderate-to-severe plaque psoriasis. Real-world data based on a representative pool of patients are currently lacking.
OBJECTIVE: To assess the mid- and long-term safety and efficacy profile of risankizumab in patients with moderate-to-severe psoriasis in the routine clinical practice.
METHODS: This was a retrospective and multicenter study of consecutive psoriatic patients on risankizumab from April 2020 through November 2022. The primary endpoint was the number of patients who achieved a 100% improvement in their Psoriasis Area and Severity Index (PASI) (PASI100) on week 52.
RESULTS: A total of 510 patients, 198 (38.8%) women and 312 (61.2%) men were included in the study. The mean age was 51.7±14.4 years. A total of 227 (44.5%) study participants were obese (body mass index [BMI] >30kg/m2). The mean baseline PASI score was 11.4±7.2, and the rate of patients who achieved PASI100 on week 52, 67.0%. Throughout the study follow-up, 21%, 50.0%, 59.0%, and 66% of the patients achieved PASI100 on weeks 4, 16, 24, and 40, respectively. The number of patients who achieved a PASI ≤2 was greater in the group with a BMI ≤30kg/m2 on weeks 4 (P=.04), 16 (P=.001), and 52 (P=.002). A statistically significantly greater number of patients achieved PASI100 in the treatment-naïve group on weeks 16 and 52 (P=.001 each, respectively). On week 16 a significantly lower number of participants achieved PASI100 in the group with psoriatic arthropathy (P=.04). Among the overall study sample, 22 (4.3%) patients reported some type of adverse event and 20 (3.9%) discontinued treatment.
CONCLUSIONS: Risankizumab proved to be a safe and effective therapy for patients with moderate-to-severe psoriasis in the routine clinical practice.