{"id":370776,"date":"2024-01-11T00:01:00","date_gmt":"2024-01-10T23:01:00","guid":{"rendered":"https:\/\/medizinonline.com\/study-shows-real-world-evidence-for-efficacy-and-safety\/"},"modified":"2024-01-11T00:01:04","modified_gmt":"2024-01-10T23:01:04","slug":"study-shows-real-world-evidence-for-efficacy-and-safety","status":"publish","type":"post","link":"https:\/\/medizinonline.com\/en\/study-shows-real-world-evidence-for-efficacy-and-safety\/","title":{"rendered":"Study shows real-world evidence for efficacy and safety"},"content":{"rendered":"\n

The prevalence of ulcerative colitis (CU) in Switzerland is 1\/500. The JAK inhibitor tofacitinib has been an arrow in the treatment quiver since 2019. In the phase 3 OCTAVE study, it proved to be effective in achieving and maintaining clinical and endoscopic remission compared to placebo. In the real world, however, the data situation in Switzerland has so far been inadequate. A study group has now addressed this issue.<\/strong><\/p>\n\n\n\n

The aim of the post-marketing study FACES (First Tofacitinib Experience in Switzerland) <\/em>was to assess the efficacy and safety of tofacitinib in the treatment of adults with moderate to severe ulcerative colitis in Switzerland under real-world conditions. In accordance with the OCTAVE study design, the research group assessed clinical and endoscopic activity at baseline and at weeks 8, 26 and 52 using the Mayo score, as explained by Prof. Dr. Alain Schoepfer, Department of Gastroenterology and Hepatology, Lausanne University Hospital, and member of the FACES survey group [1]. Tofacitinib was administered 2\u00d7 10 mg per day during the 8-week induction phase and 2\u00d7 5 mg during the maintenance phase. <\/p>\n\n

In the Mayo scoring system, the factors stool frequency, rectal bleeding, endoscopy findings and the physician’s overall assessment are taken into account to evaluate the activity of CU. Each of these four components is rated individually from 0 to 3, resulting in a total score of 0 to 12.<\/p>\n\n

Significant decline in Mayo score<\/h3>\n\n

The researchers included 104 adults in their study (mean age 41 \u00b1 14.4 years, median duration of illness 6 years, IQR 3- 11, range 1-44 years, 48.1% women). The patients’ diseases were localized:<\/p>\n\n