Pavel Svoboda

Clinical monitoring: infliximab biosimilar CT-P13 in the treatment of Crohn’s disease and ulcerative colitis

Abstract Objective: The infliximab biosimilar CT-P13 (Remsima®, Inflectra®) was approved in Europe for the treatment of inflammatory bowel disease (IBD) based on extrapolation of data from patients with rheumatic disease. Because there are limited published reports on clinical outcomes for IBD patients treated with CT-P13, we monitored responses to induction treatment with this biosimilar in patients with Crohn’s disease (CD) or ulcerative colitis (UC) in centres across the Czech Republic. Material and methods: Fifty-two patients with CD (n = 30) or UC (n = 22) were treated with 5 mg/kg CT-P13 for up to 14 weeks. Effectiveness of therapy was evaluated with the Crohn’s Disease Activity Index (CDAI) or the Mayo Scoring System (MSS) in patients with CD or UC, respectively, before and after 14 weeks. Additional goals were to evaluate weight changes, serum C-reactive protein (CRP) levels, and complications/adverse events. Results: In patients with CD, remission (CDAI <150) was achieved in 50.0% of cases, and partial response (≥70-point decrease in CDAI score from baseline) in the remaining 50.0%. In patients with UC, remission (total score on partial Mayo index ≤2 points) was achieved in 40.9% of cases, partial response (≥2-point decrease in partial Mayo score from baseline) in 54.5%, and no response in 4.5%. There were statistically significant improvements in CDAI, MSS and CRP serum levels after 14 weeks of therapy, and body weight increased. Four adverse events were identified (n = 1 each): lower-extremity phlebothrombosis, herpes labialis, pneumonia and allergic reaction. Conclusions: This prospective observational study provides evidence of the effectiveness of CT-P13 in IBD.

Acute upper gastrointestinal bleeding in liver cirrhosis patients.

OBJECTIVES This study focuses on the etiology of acute upper gastrointestinal (GIT) bleeding in liver cirrhosis patients. METHODS A prospective examination of 137 liver cirrhosis patients with acute upper GIT bleeding. All patients underwent endoscopic examination and in the case of multiple findings, definition of the source of bleeding was based on the endoscopic report. RESULTS The most frequent causes of acute bleeding were: oesophageal varices (57.7%), peptic gastric and duodenal ulcers (18.2%), portal hypertension gastropathy (9.5%), gastric varices (5.1%), reflux oesophagitis (2.9%), Mallory-Weiss syndrome (2.9%) and erosive gastropathy (1.5%). A negative diagnosis was made in not more than 2.2% of patients. The majority of cases showed multiple findings in the upper digestive tract, each of which was a potential cause of bleeding. The mortality in all bleeding cirrhotic patients was 14.6%, 18.6% of which occurred in the varicose type of bleeding and 7.8% in the non-varicose type. CONCLUSIONS Portal hypertension led to bleeding caused by varices and portal hypertension gastropathy in 72.3% of patients, 62.8% of patients suffered from purely varicose bleeding and 37.2% from non-varicose bleeding. Early, detailed endoscopic examination leading to appropriate diagnosis and treatment is of paramount importance.