Celltrion has presented phase 1 and 3 clinical trials for Remsima SC, the subcutaneous (SC) version of Remsima, an infliximab biosimilar, at the United European Gastroenterology Week (UEGW) and American College of Rheumatology (ACR).
The clinical trial compared the pharmacokinetics, immunogenicity, efficacy and safety of the intravenous (IV) and subcutaneous (SC) injection form of Remsima with active rheumatoid arthritis and active Crohn's disease patients, the company said.
Celltrion has developed Remsima SC to obtain a competitive edge in the TNF-α inhibitor market along with its existing IV formulation of Remsima. Since May 2016, Celltrion has conducted phase 1 and 3 clinical trials to confirm the safety, pharmacokinetic and efficacy of Remsima SC.
In the clinical study, the company divided the active rheumatoid arthritis and active Crohn's disease patients into two groups.
Afterward, the Celltrion gave Remsima IV to both groups during the initial two weeks of administrations. From week six, the company administered either Remsima IV or SC depending on the group at intervals of eight weeks and conducted pharmacokinetics, immunogenicity, efficacy and safety of each group for 54 weeks.
As a result, the drug concentration in the Remsima SC group remained stable compared with the group administered with Remsima IV, while the safety data were both equal among the groups.
The researchers also confirmed the efficacy of the treatment, as the result showed an increase in the Crohn's Disease activity index (CDAI) 70 and EULAR classification criteria for rheumatoid arthritis scores.
“In this trial, we confirmed that the efficacy and safety results between Ramshima IV and SC formulations were similar,” said Professor Shomron Ben-Horin from the Tel Aviv University’s Sheba Medical Center, who gave the presentation at the UEGW.
Remsima SC has shown the potential as an attractive alternative treatment to the global medical workers and patients, he added.