Celltrion Healthcare have announced two new data sets relating to the use of the subcutaneous formulation of infliximab, Remsima® SC (CT-P13 SC), in inflammatory bowel disease (IBD) at a poster presentation at UEG Week Virtual 2020.
The first study investigated the association between the pre-dose serum of infliximab concentrations, with clinical efficacy and fecal calprotectin (FC) response. The results show a positive association between CT-P13 SC exposure with both efficacy and FC outcomes in patients with Crohn’s disease (CD) and ulcerative colitis (UC).
Among 54 patients in the SC arm who have completed the CT-P13 SC maintenance treatment up to Week 54, 42 (77.8%) patients achieved clinical remission at Week 54. 1 Upon subgrouping patients according to quartiles of drug level exposure, the analysis shows that as a proportion, patients with the highest infliximab exposure (>26.7 μg/mL) achieved highest efficacy outcomes.
The second study presented investigated the accuracy of the use of FC in monitoring mucosal change in a controlled trial of CT-P13 SC and IV for patients with moderate to severe UC. The results of this trial demonstrate that FC levels are associated with changes in status of mucosal inflammation, and specifically with improved endoscopic activity in UC patients who are treated with CT-P13 SC.
A total of 68 UC patients were included in the multicentre, randomised controlled pivotal trial with 33 patients in the SC arm and 35 in the IV arm. At baseline, the median FC level in the entire cohort was 880 µg/g (786 µg/g and 978 µg/g in the SC and IV arms, respectively). 59 of 68 (86.8%) patients achieved FC level > 250 µg/g overall. In the SC arm, this accounted for 29 of 33 patients (87.9%), and in the IV arm, 30 of 35 patients (85.7%). The proportion of patients with FC level > 250 µg/g decreased to 39.0% (23/59) overall at week 22; with 44.4% (12/27) in the SC arm, and 34.4% (11/32) in the IV arm.
Professor Walter Reinisch, Director of Clinical IBD Study Group, Department of Gastroenterology and Hepatology, Medical University of Vienna said, “These promising results support the use of the subcutaneous formulation of Remsima® in inflammatory bowel disease as an alternative option for eligible patients with UC and CD. In addition, the use of FC for monitoring the mucosal response to infliximab SC presents a viable, non-invasive choice for monitoring treatment – providing patients and clinicians with greater flexibility to suit their needs.”
Reinisch, W., et al. (2020). Evaluation of clinical relationship between fecal calprotectin and endoscopic findings in ulcerative colitis patients treated with infliximab (ct-p13) subcutaneous and intravenous therapy: results from a multicenter, randomized, controlled pivotal trial. E-Poster Presentation (P0593). Presented at UEG Week Virtual 2020.