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Summary Background Whether therapeutic drug monitoring (TDM) of infliximab should be implemented in daily practice is an ongoing controversy. Aims To assess the real-world use of TDM in an observational multicentre cohort study with consecutive patients with inflammatory bowel disease (IBD) treated with CT-P13. Methods Between September 2015 and December 2016, 364 patients with IBD were treated with CT-P13 in 13 gastroenterology departments and were followed up for 54 weeks. Disease activity, CT-P13 trough concentration and anti-CT-P13 antibody (ACA) were recorded. Results Steroid-free clinical remission rates at week 54 were 67.0% and 56.4% in patients with CD and UC, respectively. CT-P13 trough concentrations were measured in 70.7% of the patients. The mean CT-P13 trough concentration was 4.2 ± 4.3 μg/mL. The presence of ACA was observed in 53 (15.9%) patients. CT-P13 trough concentration was collected in a proactive approach in 62.8% of cases and in a reactive approach in 37.2%. Among patients who submitted to TDM, CT-P13 therapy was optimized in 88.7% of the reactive group and in 22.5% of the proactive group (P Conclusion In a real-world cohort of patients with IBD treated with CT-P13, more than two-thirds of the patients underwent TDM. CT-P13 optimization was much less common in the proactive approach than in the reactive approach.

Background Patients’ perspectives after switching from infliximab to a biosimilar have yet to be assessed. Aim To assess patients’ perspectives in a prospective manner after switching from infliximab to CT-P13. Methods 113 consecutive patients with inflammatory bowel disease (IBD) on maintenance therapy with infliximab were switched to CT-P13. Patients’ perspectives were assessed by questionnaires, including the Beliefs about Medicines Questionnaire (BMQ) and FACIT-F (questionnaire regarding fatigue), and patient-reported outcomes (IBD disability index) at the inclusion and after the fourth CT-P13 infusion. Results After one year, the patients’ perspectives did not change after the switch according to BMQ-general, BMQ-specific necessity and BMQ-specific concerns subscales. No difference was observed in the mean IBD-DI score, while a significant improvement in fatigue was observed according to the FACIT-F questionnaire. Patients’ concerns were raised about the use of biosimilars and the risks of switching with a significant improvement after switching (65% vs. 42%, respectively, p = 0.01). Fourteen (12.4%) patients experienced loss of response to CT-P13, including 12 with restoration of steroid-free clinical remission after CT-P13 dose optimization. Conclusion Although some concerns were reported, no difference was observed in patients’ perspectives after switching from infliximab to CT-P13.

Revue du rhumatisme - In Press.Proof corrected by the author Available online since samedi 24 janvier 2015