Subject(s)
Celiac Disease/complications , Takayasu Arteritis/complications , Abdominal Pain/etiology , Celiac Disease/diagnosis , Celiac Disease/diet therapy , Celiac Disease/pathology , Diet, Gluten-Free , Female , Gastroscopy , Humans , Middle Aged , Stomach/pathology , Takayasu Arteritis/diagnostic imaging , Takayasu Arteritis/therapySubject(s)
Colitis, Ulcerative , Drug Hypersensitivity Syndrome/diagnosis , Infliximab/administration & dosage , Skin/pathology , Sweet Syndrome , Adult , Azathioprine/adverse effects , Biopsy/methods , Colitis, Ulcerative/complications , Colitis, Ulcerative/diagnosis , Colitis, Ulcerative/drug therapy , Dermatologic Agents/administration & dosage , Diagnosis, Differential , Glucocorticoids/administration & dosage , Humans , Male , Sweet Syndrome/complications , Sweet Syndrome/diagnosis , Sweet Syndrome/drug therapy , Sweet Syndrome/physiopathology , Treatment OutcomeABSTRACT
BACKGROUND: CT-P13 is a biosimilar of Remicade®, an agent approved in some countries for use in inflammatory bowel disease (IBD). Controlled clinical trials have demonstrated the efficacy and safety of CT-P13 in rheumatic diseases, but not in IBD. AIMS: To assess the effectiveness and safety of CT-P13 in IBD patients in real clinical practice. METHODS: This is a prospective observational study in patients with moderate to severe Crohn's disease or ulcerative colitis treated with CT-P13. The study was performed in one single center. Patients included were naive or switched to anti-TNF treatment from the reference infliximab (Remicade®) to CT-P13. Efficacy and safety were assessed in naive and switched patients who were in remission at the time of the switch at months 3 and 6 of therapy. RESULTS: 87.5 and 83.9% of switched CD patients who were in remission at the time of the switch continued in remission, and 66.7 and 50% of naive CD patients reached remission, at months 3 and 6. In UC switched cases, 92 and 91.3% of patients in remission at the time of the switch continued in remission, at 3 and 6 months. In naive UC patients, the remission rates were 44.4 and 66.7%, at months 3 and 6. Adverse events occurred in 7.5% of patients during 6 months of study. CONCLUSIONS: CT-P13 was efficacious and well tolerated in patients with CD or UC.
