Celltrion Healthcare presented new findings at the Annual European Congress of Rheumatology (EULAR 2019) on the efficacy and safety of its novel subcutaneous (SC) formulation of CT-P13 in patients with rheumatoid arthritis (RA).
CT-P13 is a tumor necrosis factor (TNF) blocker and a biosimilar of infliximab. The first part of the study included 48 patients who were randomized to either intravenous (IV) CT-P13 3mg/kg every 8 weeks or CT-P13 SC 90mg, 120mg or 180mg every 3 weeks for up to 54 weeks. Results showed the overall efficacy at week 54 and the safety profile at week 6 of CT-P13 SC were comparable to CT-P13 IV. Both the Disease Activity Score-28 (DAS28 [CRP]) and the American College of Rheumatology 20% improvement criteria (ACR20) score were found to be similar across all 4 cohorts.
Part 2 of the study was a phase 1/3 trial conducted in 348 RA patients randomized at week 6 to receive either CT-P13 SC 120mg bi-weekly (n=169) or IV 3mg/kg every 8 weeks (n=179) over 30 weeks. CT-P13 SC was found to be non-inferior to CT-P13 IV with a similar mean change in DAS28 (CRP) and similar ACR responses from baseline to week 22. The safety profiles at week 6 were comparable between the 2 treatment arms.
“The SC formulation of biosimilar inﬂiximab, CT-P13, could address unmet needs in maintenance therapy and provide an affordable, convenient, and personalized treatment option,” said Professor Rieke Alten, Head of the Department of Internal Medicine, Rheumatology, Clinical Immunology and Osteology at Schlosspark-Klinik, Teaching Hospital of Charité, Berlin, Germany. “The results seen to-date demonstrate CT-P13 SC has the potential to be an innovative biosimilar treatment – improving convenience and allowing patients to have more control of their treatment and enjoy life again.”
The Food and Drug Administration (FDA) approved CT-P13 in April 2016 under the trade name Inflectra (infliximab-dyyb). Inflectra is currently available as 100mg lyophilized powder for IV infusion in single-use 20mL vials.
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