Data shows efficacy for subcutaneous formulation of infliximab biosimilar in RA

Celltrion Healthcare has presented data from a study further investigating the efficacy, pharmacokinetics and safety of CT-P13 SC – a subcutaneous biosimilar of infliximab – over a one-year treatment period and after switching from CT-P13 IV to CT-P13 SC in people with rheumatoid arthritis (RA).

A previous study demonstrated the non-inferiority of CT-P13 SC to CT-P13 IV and compared the efficacy, pharmacokinetics and safety profiles of CT-P13 SC with CT-P13 IV in people with RA over 30 weeks.

People who received full doses of CT-P13 IV 3 mg/kg at Weeks 0 and 2 were randomly assigned to receive either CT-P13 SC 120 mg via pre-filled syringe biweekly (from Week 6 to Week 28) or CT-P13 IV  3mg/kg every 8 weeks (from Week 6 to Week 22). From Week 30 all people received CT-P13 SC 120 mg via pre-filled syringe biweekly up to Week 54.1

The efficacy up to Week 54 showed a similar trend between CT-P13 SC and CT-P13 IV arms even after switching from IV to SC treatment at Week 30 in terms of DAS28 (CRP) mean scores, ACR20/50/70 and EULAR-CRP response.

In the CT-P13 SC arm, the mean serum concentration before study drug administration increased from Week 6 and generally maintained a consistent level from Weeks 14 to 54 as a result of biweekly CT-P13 SC injections. After switching from IV to SC at Week 30, the mean serum concentration gradually increased from Week 30 and maintained a consistent level up to Week 54.1

The results after switching from IV to SC treatment at Week 30 were comparable to that of maintaining CT-P13 SC up to Week 54 (up to Week 64 for safety profile). The proportion of people who had anti-drug antibody (ADA) positive results and had post-treatment ADA positive results were comparable between the two arms and numerically lower in the CT-P13 SC arm.

“The results show that the novel SC formulation of CT-P13 via pre-filled syringe could provide a favourable benefit to people with an alternative convenient way of administration,” said Professor Rene Westhovens, Rheumatologist at the University Hospitals KU Leuven, Belgium.

Celltrion Healthcare also announced data from a first-in-human study of CT-P17, a recombinant humanised monoclonal antibody developed as a biosimilar to the reference product adalimumab.

The study was designed to evaluate the safety, including immunogenicity and pharmacokinetics, of CT-P17 (40 mg/0.4 mL) compared with EU-reference adalimumab (40 mg/0.4 mL) in healthy male subjects.2

In this phase 1, randomised, double-blind, active comparator study, healthy male subjects aged 18 to 55 years (N = 30) were randomised in a 1:1 ratio to receive 40 mg of either CT-P17 or EU-reference adalimumab by SC injection.

Single SC doses of 40 mg of CT-P17 or EU-reference adalimumab were well-tolerated and the safety profile of CT-P17, including immunogenicity, was comparable with that of EU-reference adalimumab in these healthy male subjects.

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