Celltrion Healthcare showcases positive 1-year data and budget impact analysis for novel subcutaneous formulation of infliximab in patients with rheumatoid arthritis at the European E-Congress of Rheumatology 2020

• 1-year data from a randomised controlled trial in patients with rheumatoid arthritis (RA) show no impact of body mass index (BMI) on clinical response to subcutaneous infliximab (Remsima^® SC / CT-P13 SC)^[i]
• Additional data show no differences in clinical response between CT-P13 SC and intravenous infliximab (CT-P13 IV) in terms of immunogenicity over one year^[ii]
• Remsima^® SC has the potential to offer substantial cost savings to healthcare systems as shown by new budget impact analysis data³

Thursday 4^th June 2020, 07:01 KST, Incheon, South Korea – At the European E-Congress of Rheumatology 2020 (The European League Against Rheumatism (EULAR) 2020 E-Congress), Celltrion Healthcare today showcased three sets of data relating to a subcutaneous formulation of infliximab, Remsima^® SC.

The first study demonstrated no impact of body mass index (BMI) on clinical response to CT-P13 SC in patients with active rheumatoid arthritis (RA).¹ The post-hoc study investigated the impact of BMI on clinical response to CT-P13 SC in part 2 of a phase I/III randomised controlled trial (RCT) in 165 patients throughout a 1-year treatment period.¹ Patients were categorized into 3 groups; under/normal weight (<25kg/m²), overweight (≥25kg/m², <30kg/m²), and obesity (≥30kg/m²) based on the WHO BMI classification. The three groups received at least one full dose of CT-P13 SC (after IV induction) in the initial treatment stage before week 30. The data show that the mean change from baseline of DAS28 (CRP) (-3.3, -3.1, -3.3 at week 54), duration of low disease activity (LDA) up to Week 54 (26.2, 29.2, 27.9 weeks), and the good or moderate EULAR responder rates (84.1%, 80.3%, 90.2% at week 54) were all comparable among all groups and there were no statistically significant differences.¹

Rene Westhovens, rheumatologist and one of the lead investigators of the trial, Emeritus Professor at the KU Leuven, Belgium said, “The post-hoc results showed that there was no impact of BMI on the clinical responses of CT-P13 SC 120 mg biweekly in RA patients. Therefore, Remsima^® SC could be a promising therapeutic option regardless of BMI in RA patients.”

The second study presented contained 1-year data from a multicenter, randomised, controlled, pivotal trial evaluating correlation between the magnitude of anti-drug antibody (ADA) positivity and clinical outcomes in RA patients. The results indicated that clinical analysis of both ADA positivity and titer are clinically meaningful in the prediction of pharmacokinetic (PK) profile and clinical response. CT-P13 SC administration did not result in a greater incidence of ADA compared to CT-P13 IV and there were no clinical differences between the formulations.²

A third study presented at EULAR, assessing budget impact analysis (BIA) data, indicated that the introduction of CT-P13 SC could lead to substantial cost savings for healthcare systems. The analysis compared a market scenario where a proportion of patients were treated with CT-P13 SC, to an alternative scenario where CT-P13 SC was not available and all patients were treated with IV formulations.^[iii]

The data show that introduction of CT-P13 SC resulted in potential cost savings of £39.6 million in the UK over a 5-year period, equating to 4,466 additional patients who could be treated with the SC formulation. In a second scenario which took into account IV dose-escalation up to 5mg/kg to reflect the real-world setting, the savings increased to £279.6 million over a 5-year period, equating to 30,839 additional patients able to be treated with CT-P13 SC.³

“Self-injection will significantly reduce the burden on healthcare delivery allowing resource to be spent elsewhere,” said Dr. Martin Perry at Royal Alexandra Hospital, United Kingdom. “With the pressure of meeting patient need and the increasing burden on healthcare systems, there is a greater demand than ever to deliver new and innovative treatment options that enable patients to live more independently, reduce the time spent in hospitals and in turn, lessen the pressures put on healthcare systems.”

“Remsima^® SC has the potential to offer patients a more convenient method of administration, whilst retaining the same clinical benefits found in the IV formulation of Remsima^®,” said Mr. Hyoung-Ki Kim, Vice Chairman at Celltrion Healthcare. “This should not only bring improvements to quality of life for patients, but also to healthcare systems who we anticipate could experience both time and cost savings by enabling home administration of Remsima^® SC.”