Studies Reveal Positive Results for Infliximab Biosimilar

June 18, 2020
Tony Hagen
Tony Hagen

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.

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 findings were reported in an article by our sister publication The Center for Biosimilars.

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.

Read the full article on The Center for Biosimilars.