A new formulation of CT-P13, a biosimilar of Remicade (infliximab), given as an under-the-skin injection is as safe and effective for people with active Crohn’s disease (CD) and ulcerative colitis (UC) as its approved intravenous version, known as Remsima, clinical trial data show.
Switching from intravenous (into-the-vein, IV) Remsima to this under-the-skin (subcutaneous, SC) formulation was also seen to be safe in patients.
Celltrion Healthcare, which developed both forms, is planning to request U.S. Food and Drug Administration approval for its SC version later this year, the company said in a press release.
“The 1-year results including switching results show a comparable efficacy and safety profile between CT-P13 SC and IV,” professor Shomron Ben-Horin, MD, with Chaim Sheba Medical Center in Israel and a principal researcher for the Phase 1 trial, said in the release.
“These observations support the world’s first infliximab SC formulation as a viable therapeutic agent to expand patients’ treatment options,” he added.
Remicade, by Janssen Immunology, is a synthetic antibody engineered to block the signals of the pro-inflammatory tumor necrosis factor alpha (TNFα) molecule, which is a key driver of inflammation in inflammatory bowel disease (IBD). The therapy is approved for a number of autoimmune disorders, including IBD, but is costly.
Celltrion developed CT-P13 as a biosimilar to Remicade, meaning it holds similar safety and efficacy profiles but is less costly. Remsima, this treatment given as a slow IV infusion, is approved across some 110 countries, including Europe and the U.S.
A subcutaneous injection form would be more convenient, and potentially an at-home therapy.
The open-label Phase 1 trial (NCT02883452) evaluated the safety and efficacy of CT-P13 SC compared to Remsima in 131 patients with active CD and UC. A total of 105 people (80.2%, 55 in the CT-P13 SC group, and 50 in the CT-P13 IV group) completed the one-year treatment.
Of these, 66 were randomly assigned to CT-P13 SC injection at either 120 mg or 240 mg (depending of body weight; below or above 80 kg, about 175 pounds) every two weeks, and the other 65 to Remsima at 5 mg/kg every eight weeks. Both groups received an initial loading dose by IV (5mg/kg) at the study’s start and week two.
At week 30, patients given the IV formulation switched to the SC form, following the dose-weight criteria.
Results showed that the Crohn’s Disease Activity Index (CDAI) score and partial Mayo scores — both measures of disease activity — were lower in both groups by week 30. Clinical improvements continued to be seen at week 54 after the patients switched to the new formulation.
Treatment response and remission rates were maintained at week 54. At this time, patients also showed enhanced mucosal healing.
Patients who switched from Remsima to CT-P13 SC showed concentrations of CT-P13 in their blood comparable to patients in the SC-only group. CT-P13 levels in both groups were stable and maintained stable through week 54.
Researchers also observed that CT-P13 treatment was safe at week 30 and later.
These results were shared in the oral presentation, “A novel subcutaneous infliximab (CT-P13): 1-year results including switching results from intravenous infliximab (CT-P13) in patients with active Crohn’s Disease and Ulcerative Colitis” at the European Crohn’s and Colitis Organisation (ECCO) 2020 Annual Congress, that took place in Vienna on Feb. 12–15. The presentation was selected as one of the highlights of ECCO 2020.
“I highly anticipate the approval decision for the inflammatory bowel disease indication in the coming months,” Ben-Horin said.