During Digestive Disease Week 2019, held May 18-21 in San Diego, California, researchers presented the 1-year results of a phase 1 trial of subcutaneous CT-P13 versus the intravenous formulation of the biosimilar in patients with Crohn disease (CD).
Celltrion’s proposed subcutaneous formulation of its infliximab biosimilar, CT-P13 (Remsima, Inflectra) is currently under European Medicines Agency evaluation, and the proposed formulation of the drug will also be studied in the United States in a phase 3 program in patients with inflammatory bowel disease.
During Digestive Disease Week 2019, held May 18-21 in San Diego, California, researchers presented the 1-year results of a phase 1 trial of subcutaneous CT-P13 versus the intravenous formulation of the biosimilar in patients with Crohn disease (CD).1
Patients (n = 44) who had moderate to severe CD—defined as a Crohn Disease Activity Index score of 220 to 450—were given IV CT-P13 at 5 mg/kg at weeks 0 and 2, then randomized into 4 cohorts of 11 patients each.
One cohort continued to receive the IV biosimilar every 8 weeks, while the second, third, and fourth cohorts each received the subcutaneous biosimilar at doses of 120 mg, 180 mg, and 240 mg, respectively, every 2 weeks up to week 54.
At week 30, overall clinical response rates among cohorts were similar. Clinical remission was numerically higher in the subcutaneous therapy cohorts at week 54 (8 patients, 7 patients, and 4 patients in the respective subcutaneous groups versus 4 patients in the IV group).
The mean predose serum concentration of infliximab before the next dose was higher in the subcutaneous cohorts throughout the study versus the IV group. Ctrough levels increased as the subcutaneous dose increased, and were substantially higher than the target therapeutic concentration.
The safety profiles of the IV and subcutaneous formulations were comparable, and 11.4% of patients had injection-site reactions, all in the subcutaneous administration group.
The authors concluded that the novel formulation of the biosimilar infliximab had similar efficacy and safety to the IV formulation at 1 year, and that this formulation could expand treatment options for patients with CD by providing high consistency in drug exposure during maintenance therapy.
In addition to making an appealing choice for patients who are satisfied with treatment with intravenous infliximab but who prefer or need a subcutaneous route of administration, the new formulation of CT-P13, said Celltrion in a recent statement, could compete with brand-name adalimumab (Humira), another subcutaneously administered anti—tumor necrosis factor therapy.
1. Byong DY, Byung IJ, Borzan V, et al. A novel formulation of CT-P13 (infliximab biosimilar) for subcutaneous administration: 1-year result from a phase 1 open-label randomized controlled trial in patients with active Crohn’s disease. Presented at: Digestive Disease Week 2019, San Diego, California, May 18-21, 2019. Abstract Tu1715.