New Subcutaneous Formulation of Celltrion Healthcare’s CT-P13 (biosimilar infliximab) Shows Positive Results for the Treatment of Rheumatoid Arthritis (RA) In Data Presented at the Annual European Congress of Rheumatology (EULAR 2019)
Overall, the efficacy results of CT-P13 SC up to week 54 were comparable to those of CT-P13 IV.
Celltrion Healthcare today presented new findings at the Annual European
Congress of Rheumatology (EULAR 2019) from a two-part study
investigating the pharmacokinetics, efficacy and overall safety of
CT-P13 SC in patients with RA during the treatment period of one year.
The second part of the study demonstrated the non-inferiority of the
efficacy and compared safety profiles of CT-P13 SC to CT-P13 IV in
people with RA over 30 weeks.
Part one of the study enrolled 50 patients of which 48 patients were
randomly assigned at week six into four cohorts in a 1:1:1:1 ratio. The
IV cohort received CT-P13 IV 3mg/kg every eight weeks and the SC cohorts
received CT-P13 SC 90mg, 120mg or 180mg, respectively, every two weeks
up to week 54. Overall, the efficacy results of CT-P13 SC up to week 54
were comparable to those of CT-P13 IV. Disease improvement was assessed
using the DAS28 (CRP), a disease activity score, and ACR20 score for RA.
Results demonstrated that DAS28 (CRP) and ACR20 were comparable across
all four cohorts, regardless of the route of administration or dosage of
CT-P13. The safety profiles at week six in CT-P13 SC were comparable to
CT-P13 IV and were similar to those previously reported for IV
infliximab.1
This study was followed by a phase I/III randomised controlled trial. A
total of 362 RA patients were enrolled, of whom 348 were randomised at
week six into two treatment arms in a 1:1 ratio (169 and 179 patients in
SC 120mg bi-weekly or IV 3mg/kg arms every 8 weeks, respectively). The
aim of the study was to compare the safety profiles and demonstrate the
non-inferiority of efficacy of CT-P13 SC and CT-P13 IV in people with RA
over 30 weeks. The trial showed that the mean change of DAS28 (CRP) from
baseline to week 22 was similar between the two arms. The lower limit of
the 95% CI (0.03) for the treatment difference in the change of DAS28
(CRP) from baseline was greater than the pre-specified non-inferiority
margin (-0.6) indicating non-inferiority of CT-P13 SC compared to CT-P13
IV. ACR responses were also similar between the two treatment arms up to
week 22. The safety profile at week six in the SC 120mg arm was
comparable to the IV 3mg/kg arm.2
Professor Rieke Alten, Head of the Department of Internal Medicine,
Rheumatology, Clinical Immunology and Osteology at Schlosspark-Klinik,
Teaching Hospital of Charité, Berlin, Germany said, “Despite
improvements in treating RA, there is still a significant way to go to
help patients and reduce the burden of the disease. Today, pain, fatigue
and the psychological issues connected with RA really impact patients on
a daily basis, and with frequent visits to hospitals, it is crucial that
we find an effective treatment option for patients. The SC formulation
of biosimilar infliximab, CT-P13, could address unmet needs in
maintenance therapy and provide an affordable, convenient, and
personalised treatment option. The results seen to-date demonstrate
CT-P13 SC has the potential to be an innovative biosimilar treatment –
improving convenience and allowing patients to have more control of
their treatment and enjoy life again.”
In a separate study, Celltrion investigated the long-term safety and
efficacy of CT-P13 up to five years in people with RA and ankylosing
spondylitis (AS), including patients who switched from reference
infliximab to CT-P13. The study collected and analysed data from 491
patients (154 RA and 337 AS), including 19 and 118 switched patients
with RA and AS, respectively. The probability of drug survival at year
five for patients with RA was 0.42 and 0.53, respectively for naïve and
switched patients. The probability of drug survival at year five for
patients with AS was 0.64 and 0.72, respectively for naïve and switched
patients. This five-year analysis of medical records showed that long
term treatment with CT-P13 was safe and efficacious based on drug
survival, disease activity measurements and adverse events. Drug
survival was similar between patients who were naïve at the start of
CT-P13 treatment and switched from reference to CT-P13.
Mr Hyoung-Ki Kim, Vice Chairman at Celltrion Healthcare said, “We at
Celltrion Healthcare are proud to be leading in the biosimilar space,
providing physicians with accessible treatment options that suit the
individual needs and preferences of their patients, whether that is
intravenous or subcutaneous, is important to us. Such innovations in
drug administration are shown to really benefit patients and so, being
able to offer CT-P13 SC, with the new pharmaco-economic value expected
with dual formulation of infliximab, could offer patients a more
convenient treatment option reducing the time spent in hospitals.”
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Notes to Editors
About CT-P13 (biosimilar infliximab)
CT-P13 is developed and
manufactured by Celltrion, Inc. and was the world’s first monoclonal
antibody biosimilar approved by the European Commission (EC). It is
indicated for the treatment of eight autoimmune diseases including
rheumatoid arthritis and IBD. It was approved by the EC under the trade
name Remsima® in September 2013 and launched in major EU
countries in early 2015. The US FDA approved CT-P13 in April 2016 under
the trade name Inflectra®. CT-P13 is approved in more than 89
countries (as of May 2019) including the US, Canada, Japan and
throughout Europe.
About Celltrion Healthcare
Celltrion Healthcare is committed
to delivering innovative and affordable medications to promote patients’
access to advanced therapies. Its products are manufactured at
state-of-the-art mammalian cell culture facilities, designed and built
to comply with the US FDA cGMP and the EU GMP guidelines. Celltrion
Healthcare endeavors to offer high-quality cost-effective solutions
through an extensive global network that spans more than 120 different
countries. For more information please visit: http://www.celltrionhealthcare.com/
1 Yoo DH, et al. A Novel Formulation of CT-P13
(Infliximab Biosimilar) for Subcutaneous Administration: One Year
Results from Part One of a Phase I/III Randomised Controlled Trial in
Patients with Rheumatoid Arthritis. Poster Presented at the Annual
European Congress of Rheumatology (EULAR 2019).
2
Westhovens R, et al. A Novel Formulation of CT-P13 (Infliximab
Biosimilar) for Subcutaneous Administration: 30-week Results from Part
Two of a Phase I/III Randomised Controlled Trial in Patients with
Rheumatoid Arthritis Poster Presented at the Annual European Congress of
Rheumatology (EULAR 2019).
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