New data show non-inferiority of efficacy for subcutaneous formulation of CT-P13 (biosimilar infliximab) to intravenous formulation of CT-P13 in people with rheumatoid arthritis

• The results after switching from intravenous (IV) to subcutaneous (SC) treatment at Week 30 were comparable with that of maintaining CT-P13 SC up to Week 54 (up to Week 64 for safety profile)^[i]
• The study showed CT-P13 SC achieved a sustained mean serum concentration  and demonstrated a comparable efficacy profile; CT-P13 SC could provide a benefit to patients with an alternative, convenient way of administration¹
• Celltrion Healthcare also presented data from the first-in-human study of CT-P17, a recombinant humanised monoclonal antibody that was developed as a biosimilar to the reference product, adalimumab^[ii]

SATURDAY 9^TH NOVEMBER – ATLANTA, USA – Celltrion Healthcare today announced data, at the American College of Rheumatology (ACR) annual meeting, from a study further investigating the efficacy, pharmacokinetics and safety, including immunogenicity, of CT-P13 SC over a one-year treatment period and after switching from CT-P13 IV to CT-P13 SC in people with rheumatoid arthritis (RA).¹ 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.^[iii]

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.¹

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.¹

“Non-inferiority of efficacy for CT-P13 SC to CT-P13 IV was demonstrated by the change from baseline DAS28 (CRP) at Week 22. The serum concentration of CT-P13 SC was well maintained up to Week 54. Safety results of CT-P13 SC showed similar profiles to CT-P13 IV during the study,” said Professor Rene Westhovens, Rheumatologist at the University Hospitals KU Leuven, Belgium. “Hence, CT-P13 SC showed lower ADA than CT-P13 IV which indicates high trough level potentially leading to better PK pattern and positive efficacy profile.   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.”

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.

“Overall, the proportion of subjects with positive ADA and neutralising antibodies results after the study drug administration was similar in the two treatment groups,” said Professor Edward Keystone, Senior Consultant Rheumatologist, Mount Sinai Hospital, Toronto, Canada. “Pharmacokinetic results were also comparable between the two treatment arms.”

Mr Hyoung-Ki Kim, Vice Chairman at Celltrion Healthcare, said, “With the availability of the CT-P13 SC, patients could now be treated with infliximab SC before switching to other costly biologics with a different mechanism of action or JAK-inhibitors. Celltrion Healthcare will target CT-P13 SC as the preferred agent prior to second-line treatment in rheumatoid arthritis. Together with the subcutaneous formulation of CT-P13, the development of the biosimilar adalimumab, CT-P17, will offer opportunities in improving access to treatment and increasing treatment options worldwide.  Celltrion Healthcare remains highly committed to developing our biosimilar portfolio and delivering value to patients, payers and healthcare providers.”

[i] Westhovens R, Wiland P, Zawadzki M et al. Efficacy and Safety of a Novel Subcutaneous Formulation of CT-P13 over the 1-year Treatment Period and After Switching from Intravenous CT-P13 in Patients with Active Rheumatoid Arthritis: Results from Part 2 of Phase I/III Randomized Controlled Trial. Poster Number 0548. Presented at ACR 2019.

[ii] Keystone E, Furst D, Boyce M et al. A Pilot Phase 1, Randomized, Double-blind, Two-arm, Parallel Group, Single-dose Study to Evaluate the Safety and Pharmacokinetics of CT-P17 and Humira in Healthy Male Subjects. Poster Number 0503. Presented at ACR 2019.

[iii] Westhovens R, et al. SAT0170 A novel formulation of CT-P13 for subcutaneous administration: 30 week results from a part 2 of phase phase i/iii randomised controlled trial. Ann Rheum Dis 2019;78:1158-1159.