Celltrion Presents Positive Top-Line Efficacy and Safety Results for CT-P17 in the Treatment of Rheumatoid Arthritis

Celltrion Healthcare Presents Positive Top-Line Efficacy and Safety Results for CT-P17 in the Treatment of Rheumatoid Arthritis

• CT-P17 is the first biosimilar with high concentration (100mg/mL) and citrate-free formulation
• 24-week data has shown comparable efficacy and safety data for adalimumab biosimilar CT-P17 against reference adalimumab in rheumatoid arthritis (RA)^[i]
• Comparable pharmacokinetics (PK) and safety data was also presented for CT-P17 in comparison with EU-approved adalimumab and US-licensed adalimumab in healthy subjects^[ii]

TUESDAY 3 NOVEMBER – 04:00 KST, INCHEON, SOUTH KOREA – New data to be presented at the American College of Rheumatology (ACR) Convergence 2020 demonstrate that the efficacy, pharmacokinetics (PK) and overall safety of CT-P17, a proposed high concentration (100mg/mL) and citrate-free adalimumab biosimilar, is comparable to reference adalimumab in the treatment of rheumatoid arthritis (RA) patients. 

The randomised, double-blind, phase III study investigated the equivalence of CT-P17 to reference adalimumab in terms of efficacy, pharmacokinetics (PK) and overall safety over 24 weeks.¹ 648 patients with active moderate-to-severe RA despite methotrexate (MTX) treatment were randomly assigned to receive 40mg of CT-P17 or reference adalimumab every 2 weeks up to week 24.

Results demonstrated CT-P17 has equivalent efficacy to reference adalimumab - the ACR20 response rate at week 24 was 82.7% (268/324) for both CT-P17 and reference adalimumab. Similar additional secondary efficacy endpoints were seen in terms of ACR20/50/70 response rates, mean DAS28 (CRP), clinical disease activity index (CDAI) and simplified disease activity index (SDAI) and EULAR (CRP) response. The PK results in terms of mean C_trough of adalimumab up to week 24 were slightly higher for CT-P17 and the mean C_trough was generally lower in the anti-drug antibody (ADA) positive subgroup than the ADA negative subgroup in both treatment groups. The safety profile of CT-P17 up to week 24 was comparable to that of the reference adalimumab as the majority of events were grade 1 or grade 2 in intensity. ¹

“These phase III results show a comparable PK, efficacy and safety profile between CT-P17 and the reference adalimumab, building on evidence demonstrating that CT-P17 is equivalent to reference adalimumab for the treatment of rheumatoid arthritis”, said Professor Edward Keystone, Senior Consultant Rheumatologist, Mount Sinai Hospital, Toronto, Canada.  “These promising study results support the use of CT-P17, the first adalimumab biosimilar with high concentration and citrate-free formulation as an alternative option for eligible patients with rheumatoid arthritis.”

Further data presented by Celltrion Healthcare at ACR Convergence 2020 investigated the PK and safety of CT-P17 in comparison to EU-approved adalimumab (EU- adalimumab) and US- licensed adalimumab (US- adalimumab) in healthy subjects up to 10 weeks. In this phase I, randomised, double- blind, single-dose study, 312 healthy subjects aged 19 to 55 years were randomised in a 1:1:1 ratio to receive either CT-P17, EU- adalimumab or US- adalimumab after a single subcutaneous (SC) injection of 40mg (100mg/mL). The results showed that the 90% confidence intervals (CI) for the geometric least squares mean ratio of each of the primary PK parameters (AUC_0-inf, AUC_0-last, and C_max) were within the predefined equivalence margin of 80% to 125%. The overall safety profile was comparable, and the number of subjects who had positive ADA and neutralising ADA (NAb) results were also similar among the three treatment groups.²

Celltrion Healthcare also presented PK and safety data for two delivery methods for CT-P17, the auto-injector (AI) and pre-filled syringe (PFS). As part of the study, 193 healthy subjects were randomly split into two groups to receive 40mg of either CT-P17 AI or CT-P17 PFS. Following a single SC administration of CT-P17 via AI, mean peak and total systemic exposure (AUC_0-inf, AUC_0-last and C_max) were equivalent with those of CT-P17 PFS, which indicates that CT-P17 AI could be a viable alternative administration option.^[iii]

[i] J. Kay., et al. (2020). A Randomized, Double-Blind, Phase 3 Study to Compare the Efficacy and Safety of a Proposed High Concentration (100 mg/mL) Adalimumab Biosimilar (CT-P17) with Reference Adalimumab in Patients with Moderate-to-Severe Active Rheumatoid Arthritis. Poster Presented at ACR Convergence 2020.

[ii] Yu KS, et al. (2020). Pharmacokinetics and Safety of CT-P17, a Proposed High Concentration (100 mg/mL) Adalimumab Biosimilar, in Comparison with EU-Approved Adalimumab and US-Licensed Adalimumab; Results of a Phase 1, Randomized, Double-blind, Three-arm, Single-dose Study in Healthy Subjects. Poster Presented at ACR Convergence 2020.

[iii] E. Keystone, et al. (2020). A Phase 1, Randomized, Open-label, Parallel Group, Single-dose Study to Compare the Pharmacokinetics and Safety of the Auto-injector and Pre-filled Syringe of CT-P17, a Proposed, Higher Concentration Biosimilar (100 mg/mL) Adalimumab, in Healthy Subjects. Poster Presented at ACR Convergence 2020.