Promising Results in CD, UC for Celltrion Infliximab Biosimilar

Patients with Crohn disease (CD) and ulcerative colitis (UC) were shown to benefit from use of subcutaneous (SC) infliximab (Remsima; CT-P13) in terms of efficacy and lower fecal calprotectin (FC) levels, according to Incheon, Republic of Korea–based Celltrion Healthcare.

FC is a protein biomarker associated with active inflammatory bowel disease, which includes UC and CD. Celltrion said the findings suggest better clinical outcomes are possible via use of higher predose levels of SC infliximab.

“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,” said Walter Reinisch, director of the Clinical Inflammatory Bowel Disease Study Group for the Department of Gastroenterology and Hepatology at the Medical University of Vienna. The findings were presented at United European Gastroenterology Week Virtual 2020.

Study on FC Response

In 1 of 2 studies Celltrion presented, the infliximab biosimilar as a predose serum was evaluated according to clinical efficacy and FC response in patients with CD and UC.

Among the 54 patients enrolled in the CT-P13 SC arm who completed maintenance treatment up to week 54, 77.8% (42) achieved clinical remission.

The analysis showed that patients with the highest exposure to infliximab (>26.7 μg/mL) experienced the highest efficacy outcomes.

Study on Mucosal Monitoring

The second study was a controlled trial that investigated the accuracy of the use of FC in monitoring mucosal changes in patients with moderate to severe UC who received CT-P13 in either intravenous (IV) or SC form.

Results of the trial revealed that FC levels are associated with positive changes in mucosal inflammation, specifically with improved endoscopic activity in patients with UC who are treated with CT-P13 in SC form.

“The use of FC for monitoring the mucosal response to infliximab SC presents a viable, noninvasive choice for monitoring treatment—providing patients and clinicians with greater flexibility to suit their needs,” Reinisch said.

The multicenter, randomized, controlled pivotal trial enrolled 68 patients with UC, with 33 receiving CT-P13 in SC form and 35 receiving CT-P13 in IV form. At baseline, the median FC level was 880 mcg/g (786 mcg/g and 978 mcg/g in the SC and IV arms, respectively).

At week 22, the proportion of patients with FC levels greater than 250 mcg/g decreased to 39% (n = 23), amounting to 44.4% (n = 12) of patients in the SC arm and 34.4% (n = 11) of patients in the IV arm.

Celltrion said that, overall, 86.98% (n = 59) achieved FC levels greater than 250 mcg/g, with this occurring in 87.9% (n = 29) of patients in the SC arm and 85.7% (n = 30) in the IV arm.

In July, Remsima SC (CT-P13 SC) was granted marketing authorization from the European Commission for an additional 5 indications to include ankylosing spondylitis, CD, UC, psoriatic arthritis, and psoriasis.