Efficacy and Safety of Vedolizumab in the Treatment of Ulcerative Colitis in Real Clinical Practice: Five Years of Observation

Abstract

In real clinical practice, unlike in the registered controlled trials, the analytical group includes all patients who are being treated with a drug. The aim is to evaluate the efficacy and safety of vedolizumab (VDMB) therapy in real clinical practice in patients with ulcerative colitis (UC) for five years. Material and methods. The study included 136 patients with UC (men 53.7%, women 46.3%), average age – 33.8 ± 4.4 years, duration of the disease – 3.1 ± 0.4 years (52.9% of patients with moderate severity, 72.1% with total lesion and 64.4% with chronic recurrent course, in 17.6% of cases – extra-intestinal manifestations). Results. After 12 weeks, 53 (38.9%) patients with UC achieved a clinical response, 72 (52.9%) achieved clinical remission, 13 (9.5%) did not respond or did not respond sufficiently to therapy. After 24 weeks, clinical remission reached 72.1%, clinical response – 18.4% of patients. Of 112 patients who underwent colonoscopy (CS), 68 (60.7%) had clinical and endoscopic remission at week 24. After 52 weeks of therapy, endoscopic remission persisted in 68 (60.7%) patients, endoscopic response – in 40 (36.6%), clinical remission – in 112 (82.3%) and clinical response – in 21 (15.4%). After five years of VDMB therapy, endoscopic remission persisted in 70 (51.5%) patients, endoscopic response in 36 (26.5%), clinical remission in 105 (77.2%) and clinical response in 19 (14.0%). The survival rate of VDMB therapy in patients with UC was 90.4% after 12 months and persisted for a year, 82.3% after two years, 81.6% after five years. Steroidal remission was 91.0%. The regression of extra-intestinal manifestations after 24 weeks was noted in 58.3% of patients with UC. Conclusion. Our clinical observation of 136 patients with UC demonstrated the high efficacy and safety of VDMB