Clinical effectiveness of golimumab in ulcerative colitis : a prospective multicentre study based on the Swedish IBD Quality Register, SWIBREG
| Autor: | Erik Hertervig, Lina Vigren, Carl Eriksson, Sven Almer, Linda Nilsson, Henrik Hjortswang, Anders Kärnell, Per Karlén, Daniel Bergemalm, Isabella Visuri, Jonas Halfvarson, Hans Strid |
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| Jazyk: | angličtina |
| Rok vydání: | 2021 |
| Předmět: |
Sweden
medicine.medical_specialty business.industry Clinical effectiveness Gastroenterology Antibodies Monoclonal Golimumab clinical effectiveness inflammatory bowel disease ulcerative colitis Gastroenterology and Hepatology medicine.disease Ulcerative colitis Inflammatory bowel disease Therapy naive Clinical trial Treatment Outcome Internal medicine Gastroenterologi Humans Medicine Colitis Ulcerative Tumor Necrosis Factor Inhibitors Prospective Studies business medicine.drug |
| Popis: | Objectives Clinical trials demonstrated that golimumab is effective in anti-TNF naive patients with ulcerative colitis. We aimed to assess the clinical effectiveness of golimumab in a real-world setting. Materials and methods This was a prospective cohort study, conducted at 16 Swedish hospitals. Data were collected using an electronic case report form. Patients with active ulcerative colitis, defined as Mayo endoscopic subscore >= 2 were eligible for inclusion. The primary outcomes were clinical effectiveness at 12 weeks and 52 weeks, i.e. response (defined as a decrease in Mayo score by >= 3 points or 30% from baseline) and remission (defined as a Mayo score of 1). Results Fifty patients were included. At study entry, 70% were previously exposed to anti-TNF, 16% to vedolizumab, and 96% to immunomodulators. The 12 and 52-week drug continuation rates were 37/50 (74%) and 23/50 (46%), respectively. The 12-week response rate was 14/50 (28%), the remission rate, 8/50 (16%) and the corresponding figures at week 52 were 13/50 (26%) and 10/50 (20%). Among patients who continued golimumab, the median Mayo score decreased from 7 (6-9) at baseline to 1 (0-5) at 52 weeks (p < .01) and the faecal calprotectin decreased from 862 (335-1759) mu g/g to 90 (34-169) mu g/g (p < .01). Clinical response at week 12 was highly predictive of clinical remission at week 52 (adjusted OR: 73.1; 95% CI: 4.5-1188.9). Conclusions The majority of golimumab treated patients represented a treatment refractory patient-group. Despite this, our results confirm that golimumab is an effective therapy in ulcerative colitis. Funding Agencies|MSD; Swedish governments agreement on medical training and research [OLL-836791, OLL-929900] |
| Databáze: | OpenAIRE |
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