Celltrion Healthcare announced new 1-year data from a randomised controlled trial to evaluate the pharmacokinetics (PK), efficacy and safety of CT-P13 subcutaneous (SC) formulation compared to the CT-P13 intravenous (IV) formulation in patients with active Crohn’s disease (CD) and ulcerative colitis (UC).
Results presented at The European Crohn’s and Colitis Organisation (ECCO) 2020 annual congress in Vienna, Austria demonstrated that the SC formulation of CT-P13 was comparable to the IV formulation of CT-P13 in terms of efficacy and safety throughout the 1-year treatment period.1
In the study, 131 patients were randomised at the maintenance phase (66 to the SC arm and 65 to the IV arm), of whom 105 (80.2%) patients completed the week 54 visit (55 in the SC arm and 50 in the IV arm). After loading doses of IV 5mg/kg at weeks 0 and 2, patients were randomised at week 6 to receive either SC 120 mg (<80kg) or 240 mg (≥80 kg) every 2 weeks in the SC arm, or continued on IV 5 mg/kg every 8 weeks in the IV arm. From week 30 onwards, the IV 5 mg/kg group were switched to either SC 120 or 240 mg based on the patients’ body weight.
Professor Shomron Ben-Horin, MD, Department of Gastroenterology, Chaim Sheba Medical Center in Israel, and one of the lead investigators of the trial said, “the 1-year results including switching results show a comparable efficacy and safety profile between CT-P13 SC and IV. These observations support the world’s first infliximab SC formulation as a viable therapeutic agent to expand patients’ treatment options.” Professor Ben-Horin added, “It is exciting to hear that the abstract has been selected as one of the Highlights of ECCO and I highly anticipate the approval decision for the inflammatory bowel disease indication in the coming months.”
The study showed that the mean CDAI and partial Mayo scores decreased over time in both arms until week 30, while comparable improvement in clinical activity was observed at week 54 – after switching the remaining IV patients to SC. The rates of clinical response and remission at week 54 were maintained, and the rate of mucosal healing in CD and UC combined was further improved at week 54. Furthermore, after switching the mean pre-dose serum concentrations in the IV arm increased to a comparable level as the SC arm, and maintained consistent levels until week 54. The overall safety profile during the maintenance phase, and on or after week 30, were comparable between both the SC and IV arms.
The results were presented as part of oral presentation ‘OP24: 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’, which was selected for inclusion in the Highlights of ECCO by organisers.
“CT-P13 SC (Remsima SC) is the first and only subcutaneous infliximab to be available in Europe offering patients who are starting or switching anti-TNF-α therapy with the proven benefits of infliximab in a more convenient form. Starting with Germany, we have started launching the new subcutaneous infliximab country by country by establishing local operations across major European countries, building our commercial capabilities and strengthening our relationships with stakeholders across these markets” said Mr. Hyoung-Ki Kim, Vice Chairman at Celltrion Healthcare.
Celltrion is seeking approval for the inflammatory bowel disease (IBD) indication for CT-P13 SC (Remsima SC) in mid-2020, following EU marketing authorisation for the treatment of people with rheumatoid arthritis in late 2019.
Source: Company Press Release