Efficacy and safety of ustekinumab therapy in patients with Crohn’s disease. Real clinical practice

Abstract

Introduction.The results of registrational clinical trials (CTs) and real clinical practice do not always correlate. The task of practitioners is to find optimal approaches to the therapy of Crohn’s disease, based on the analysis of clinical trials and real-world data.Aim. To make a retrospective assessment of the efficacy and tolerability of UST therapy in patients with moderate to severe CD in real clinical practice.Materials and methods. A total of 88 patients with CD were included in the study to evaluate the efficacy and safety of UST. Among the patients, men accounted for 48.9%, women – 51.1%, the average age was 36.4 ± 4.8 years, the disease duration was 7.8 ± 2.1 years. 67.1% of patients with moderate CD in the form of ileocolitis (82.9%) had a stenosing (26.1%) and penetrating (50.0%) form of the disease. 95.4% of patients received prior immunosuppressive therapy.Results. After inductive therapy with UST, clinical response and clinical remission within 8 weeks were recorded in 86 (97.7%) patients with CD. After 26 weeks, 58 (65.9%) patients achieved clinical remission, 28 (31.8%) patients with CD and all patients who responded to UST therapy maintained clinical response. Crohn’s Disease Activity Index (CDAI) decreased from 445.8 ± 50.4 to 134.6 ± 21.4 points. Clinically significant endoscopic improvement was reported in 25 (40.3%) of 62 patients, endoscopic response in 14 (22.6%) patients, endoscopic remission in 18 (29.0%). After 26 weeks, CDAI decreased from 7.8 ± 1.8 to 2.9 ± 1.2 points, after 52 weeks it decreased from 445.8 ± 50.4 to 141.6 ± 28.2. Steroid-free remission in CD patients accounted for 68.2%. 1-year survival of UST therapy was 97.7%, 2-year survival was 95.5%.Conclusions. The observation demonstrated the high efficacy of the drug in induction and maintenance therapy in the cohort of patients with severe to moderate CD resistant to disease-modifying and genetically engineered biological drugs.