Tony Hagen is senior managing editor for The Center for Biosimilars®.
The infliximab biosimilar CT-P13 delivered positive results in studies presented at the European League Against Rheumatism's European E-Congress of Rheumatology 2020.
In studies presented this month at the European E-Congress of Rheumatology 2020, investigators revealed positive findings for the infliximab biosimilar CT-P13 (Inflectra, Remsima), which is developed by Celltrion of Incheon, Republic of Korea.
The studies concerned the influence of body mass on response for CT-P13 subcutaneous (SC) in patients with active rheumatoid arthritis (RA), the correlation between antidrug antibody (ADA) positivity and clinical outcomes in patients with RA, and the potential savings in a market scenario where patients are treated with CT-P13 SC.
Body Mass Study
The post-hoc study of body mass on clinical response to CT-P13 SC demonstrated no statistically significant differences in response between patient cohorts stratified into under/normal weight (<25kg/m2), overweight (≥25kg/m2, <30kg/m2), and obesity (≥30kg/m2), based on World Health Organization criteria.
Investigators said the mean change from baseline in disease activity score 28-joint count C reactive protein was —3.3, –3.1, and –3.3 at week 54, respectively. The duration of low disease activity up to week 54 was 26.2, 29.2, and 27.9 weeks, and the good or moderate European League Against Rheumatism responder rates were 84.1%, 80.3%, and 90.2% at week 54, respectively.
Patients in each cohort received at least 1 full dose of CT-P13 SC following intravenous induction in the initial treatment stage prior to week 30.
“The post-hoc results showed that there was no impact of [body mass index] 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,” said Rene Westhovens, a rheumatologist and one of the lead investigators in the trial.
In a second study, data from a multicenter, randomized, controlled trial demonstrated that ADA positivity and titer, or solution concentration, helped to predict pharmacokinetic profile and clinical response. Investigators said CT-P13 SC administration did not lead to a higher incidence of ADA compared with CT-P13 IV and no clinical differences between the formulations were observed.
In a third study, investigators concluded that self injection of CT-P13 could significantly reduce the burden on health care delivery. Their study suggested potential cost savings of $49.7 million over 5 years in the United Kingdom from the use of CT-P13 SC. They said the money saved was equivalent to the cost of CT-P13 treatment in an additional 4466 patients.
In a second scenario, investigators estimated potential savings of $350.7 million over 5 years based on real-world dose escalation up to 5 mg/kg. This, they said, would make it possible for an additional 30,839 patients to receive treatment with the SC formulation.
“With the pressure of meeting patient need and the increasing burden on health care 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 health care systems,” said Martin Perry, a consultant rheumatologist in the Department of Rheumatology at Royal Alexandra Hospital in Paisley, United Kingdom.
Read more about CT-P13 and a recent study that may have helped to allay concern among gastroenterologists that there is not enough evidence to support use of the agent in nonindicated uses.