Celltrion Proves Excellence of 'Remsima SC' at European Conference

[Asia Economy Reporter Cho Hyun-ui] Celltrion announced on the 4th (local time) at the European League Against Rheumatism (EULAR) that it presented clinical research data on Remsima SC conducted on rheumatoid arthritis patients. Remsima SC is the world's first infliximab formulation made into a subcutaneous injection form of the autoimmune disease treatment Remsima.

Based on the one-year clinical trial of Remsima SC presented at the conference, Celltrion disclosed the results of an evaluation on immunogenicity and the impact of body mass index (BMI). According to the study, there is no difference in immunogenicity depending on the formulation. BMI also does not affect the results of Remsima SC administration.

From week 30, Remsima SC was administered every two weeks until week 54 in the IV administration group, and from week 6 to week 54 in the SC administration group. Clinical data from these two groups confirmed that antibody response (ADA) is a meaningful indicator for predicting pharmacokinetics and efficacy results. It also proved that there is no difference in immunogenicity depending on the formulation.

Additionally, patients who received Remsima SC from week 6 to week 54 were divided into three groups?underweight/normal weight, overweight, and obese?based on the World Health Organization (WHO) classification criteria for BMI, and comparative analysis was conducted. The efficacy results of the three groups were similar, and regardless of BMI, the 120 mg dosage was confirmed as an appropriate treatment method.

A Celltrion official stated, "Remsima SC has been recognized as a new treatment option with the convenience of self-administration by proving through various clinical results that there is no difference in safety, efficacy, and immunogenicity compared to the IV formulation," adding, "Following the RA indication, we have also obtained the inflammatory bowel disease indication from the EMA, solidifying our position as a leader in autoimmune disease treatments."