Celltrion presented new research that demonstrates that a formulation of its infliximab biosimilar intended for subcutaneous administration is comparable to the intravenously administered option. The phase 1 study compared the subcutaneous formulation—which can be self-administered—with the FDA-approved intravenous formulation in patients with active Crohn disease (CD).
At Digestive Disease Week, held in Washington, DC, Celltrion presented new research that demonstrates that a formulation of its infliximab biosimilar, CT-P13 (sold in the United States as Inflectra and in the European Union as Remsima), intended for subcutaneous administration is comparable to the intravenously administered option.
The phase 1 study compared the subcutaneous formulation—which can be self-administered—with the FDA-approved intravenous formulation in patients with active Crohn disease (CD) as measured by a Crohn Disease Activity Index (CDAI) score of 220 to 450.
In total, 44 patients were randomized to 4 treatment cohorts after having been treated with intravenous CT-P13 at a dose of 5 mg/kg at weeks 0 and 2.
The first cohort continued treatment with the same dose of intravenous CT-P13 (at weeks 6, 14, 22, and 30), while the second, third, and fourth cohorts were treated with subcutaneous doses of CT-P13 at doses of 120 mg, 180 mg, and 240 mg, respectively, injected biweekly up to week 30.
Overall, the number of patients who achieved CDAI-70 (a decrease in baseline CDAI score of at least 70 points) at week 30 was similar across the 4 cohorts, at 8 (66.7%), 9 (81.8%), 10 (83.3%), and 5 (71.4%), respectively. The number of patients who achieved clinical remission at week 30 was also similar across the 4 cohorts, at 7 (58.3%), 9 (81.8%), 7 (58.3%), and 5 (71.4%), respectively.
One patient each from the first and fourth cohorts experienced hypersensitivity, but only the patient who received the intravenous formulation of infliximab tested positive for anti-drug antibodies. All injection-site reactions were grade 1 or grade 2 in intensity.
The study’s authors say that pharmacokinetic and pharmacodynamic modeling based on the comparable efficacy and safety results suggest that the subcutaneous and intravenous doses of CT-P13 are similar.
Hyoung-Ki Kim, vice chairman of Celltrion Healthcare, said in a statement that the results for the subcutaneous product are “…a significant milestone for Celltrion Healthcare and our partners. This kind of innovation will enable us to differentiate our portfolio and provide a more convenient and accessible treatment administration option to patients with chronic conditions like [inflammatory bowel disease] in the United States.”
Currently, there are no subcutaneously administered infliximab products available in the US marketplace. If eventually approved, the subcutaneous biosimilar product could allow patients greater flexibility in their treatment options for inflammatory diseases.
Schreiber S, Jang BI, Borzan V, et al. Novel formulation of CT-P13 (infliximab biosimilar) for subcutaneous administration: initial results from a phase 1 open-label randomized controlled trial in patients with active Crohn’s disease. Gastroenterology. 2018;154(6):S-1371. doi: 10.1016/S0016-5085(18)34477-9.