Опыт применения устекинумаба у бионаивных пациентов с болезнью Крона, имеющих факторы неблагоприятного прогноза: реальная клиническая практика

Abstract

The purpose of this study was to study the effectiveness of ustekinumab (UST) depending on the dosage regimen (90 mg subcutaneously once every 8 or 12 weeks) in patients with Crohn's disease (CD) who have unfavorable prognosis factors. Material and methods. To assess the effectiveness of the drug, we included in the study 38 patients with CD who had unfavorable prognosis factors, who were randomized into two groups of patients who received the drug in a 90 mg subcutaneous regimen once every 12 weeks (1-st group, n = 20) and 90 mg subcutaneously once every 8 weeks (2-nd group, n = 18). The gender and age of the patient were analyzed, including at the time of diagnosis, the severity and prevalence of CD; the presence of intestinal complications; the presence and localization of extra-intestinal manifestations; previous treatment was analyzed. Results. Clinical response and clinical remission were achieved in 19 (95.0%) patients of the first group and 18 (100.0%) patients of the second group (p > 0.05). Clinical remission was maintained (without the need for optimization of therapy) by the 52 week of follow-up in 18 (90.0%) patients, in the second group – 18 (100.0%) patients (p = 0.516). In the 1-st group 10 (50.0%) patients achieved and maintained endoscopic remission by the 52 week of follow-up, in the 2-nd group – 16 (88.9%) patients (p = 0.01492). During one year of follow-up, 10 (50.0%) patients of the 1-st group maintained clinical and endoscopic remission of CD, 8 (40.0%) patients maintained clinical response and clinical remission (a decrease of ≥ 100 points from the initial CDAI), 16 (88.9%) patients in the 2-nd group maintained clinical and endoscopic remission of CD. Clinical response and clinical remission were maintained in 2 (11.1%) patients. Clinical and endoscopic remission in patients with CD receiving the drug was achieved in the 2-nd group (p = 0.01492). Without steroidal remission in patients in 1-st group was 65.0%, and in in 2-nd group about 95% (p = 0.04502). Conclusion. This clinical observation demonstrated statistically significantly higher therapeutic efficacy (clinico-endoscopic, without steroidal remission) in CD patients with adverse prognosis factors receiving UST 90 mg subcutaneously every 8 weeks.