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)
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.”
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).
+44 203 817 6791
+44 203 817 6718
About Business Wire
(c) 2018 Business Wire, Inc., All rights reserved.
Business Wire, a Berkshire Hathaway company, is the global leader in multiplatform press release distribution.
Subscribe to releases from Business Wire
Subscribe to all the latest releases from Business Wire by registering your e-mail address below. You can unsubscribe at any time.
Latest releases from Business Wire
To Help Building and Facilities Managers Meet the Demands of Social Distancing, Bentley Systems Opens Up Full Access to LEGION Simulator and OpenBuildings Station Designer and Waives Subscription Fees through September 304.6.2020 18:03:00 CEST | Press release
Bentley Systems, Incorporated, a leading global provider of comprehensive software and digital twins services for advancing the design, construction, and operations of infrastructure, today announced it has opened up its LEGIONSimulator and OpenBuildings Station Designer software, including waiving new subscription fees through September 30, 2020, for facilities managers to incorporate pedestrian simulation methodologies across their planning, design, and operations teams. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20200604005622/en/ Top left illustrates a 3D model of a retail operation created using OpenBuildings Station Designer. Bottom left shows 2D floor plans that are then imported into LEGION Simulator (right) to test two scenarios. Examples shown are at occupancy rates of 75% (top) and 25% (bottom) to comply with social distancing requirements. (Photo: Business Wire) With social distancing and crowd management at th
European Commission Grants Marketing Authorisation for DARZALEX ® ▼ (daratumumab) Subcutaneous Formulation for all Currently Approved Daratumumab Intravenous Formulation Indications4.6.2020 16:00:00 CEST | Press release
The Janssen Pharmaceutical Companies of Johnson & Johnson announced today that the European Commission (EC) has granted marketing authorisation for DARZALEX®▼(daratumumab) subcutaneous (SC) formulation for the treatment of adult patients with multiple myeloma (MM). Daratumumab SC is administered as a fixed dose, which significantly reduces treatment time, from hours to approximately three to five minutes, when compared to daratumumab intravenous (IV) formulation.1 In addition, only the first dose of daratumumab SC needs to be administered in an environment where resuscitation facilities are available. The approval applies to all current daratumumab indications in frontline and relapsed/refractory settings, and patients currently on daratumumab IV can switch to the SC formulation should they choose to. Data supporting the approval show that daratumumab SC demonstrated a consistent overall response rate (ORR) and a similar safety profile compared with daratumumab IV in patients with rela
HCL and Google Cloud Expand Partnership to Digitally Transform Commerce4.6.2020 16:00:00 CEST | Press release
HCL Technologies (HCL), a leading global technology company, and Google Cloud today announced the expansion of their strategic partnership to bring HCL's software offerings, starting with HCL Commerce, to Google Cloud. Google Cloud will be the preferred cloud platform for HCL Commerce, providing global, secure and elastic infrastructure to power businesses’ eCommerce strategies. Under this partnership, HCL also intends to leverage Anthos to enable multi-cloud and hybrid-cloud deployments of HCL Commerce. HCL Commerce is a leading, cloud-native Commerce platform used by innovative businesses across multiple industries and around the world to drive more than $100 billion in annual client revenues. With a strong track-record of delivering rock-solid performance, scalability and functionality, HCL Commerce today is at the forefront of many organizations’ digital commerce strategies. It stretches far beyond an initial transaction and enables businesses to respond to evolving market conditio
AT&T ® México Selects MATRIXX Software for Prepaid Platform Replacement4.6.2020 15:00:00 CEST | Press release
MATRIXX Software today announced that https://cts.businesswire.com/ct/CT?id=smartlink&url=http%3A%2F%2Fwww.att.com.mx&esheet=52230127&newsitemid=20200604005138&lan=en-US&anchor=AT%26amp%3BT%26%23174%3B+M%26eacute%3Bxico&index=2&md5=52456f1fe4eebcb68026fb5ad3b2dd58 AT&T® México, a subsidiary of AT&T® USA and one of the largest mobile players in the Mexican market, is deploying MATRIXX Software’s cloud native digital commerce platform for its prepaid customers. MATRIXX Digital Commerce is replacing multiple legacy Intelligent Network (IN) and Business Support Systems (BSS) to provide a future-proof, web-scale BSS that will allow for greater innovation and business agility. MATRIXX will support both the AT&T brand and UNEFON brand on a single platform. The industry’s leading solution for real-time cloud native rating and convergent charging for 5G(CCS) and 4G(OCS), MATRIXX Digital Commerce was selected after a rigorous evaluation process that included multiple vendors. “We are proud to be
Moody’s Analytics Forecast: Resurgence of COVID-19 Could Cause Global Economic Depression4.6.2020 14:00:00 CEST | Press release
According to the Moody’s Analytics baseline economic forecast, real global GDP will fall by 4.5% this year as a result of COVID-19. Our base case for the US suggests that it will take until mid-decade for the economy to return to full-employment. Mark Zandi, Chief Economist at Moody’s Analytics, describes the outlook in a new paper, Handicapping the Paths for the Pandemic Economy. “COVID-19 has caused massive damage to the global economy. Quickly reopening economies will boost growth by unleashing pent-up demand, but will also raise the specter of a re-intensification of COVID-19 and another economic downdraft, which could lead to a worldwide depression. We construct our economic forecasts to help market participants navigate this daunting uncertainty and make better decisions,” said Mr. Zandi. The Moody’s Analytics baseline economic forecast represents our view of the most likely trajectory for the global economy. The baseline forecast is part of a set of 12 forecast scenarios, update
Vertex Enhances Integrated Tax Solution for SAP ® Ariba ®4.6.2020 13:13:00 CEST | Press release
Vertex, Inc.,a leading provider of tax technology and services, announced enhancements to its solutions integration with SAP® Ariba® Buying and Invoicing, providing customers with timely, advanced tax insights within their procurement and supply chain processes. Vertex launched an SAP Ariba Tax API and the Vertex Indirect Tax for Procurement with SAP Ariba app extension in 2018, enabling companies to obtain tax calculations from within SAP Ariba Buying and Invoicing, while also supporting the requisition and invoice reconciliation phases of the tax process. This integration with SAP Ariba solutions helps calculate tax at the purchase requisition, invoice reconciliation and final tax determination phases, carrying tax from the purchase requisition to the purchase order. The integrated solution is now enhanced to distinguish between vendor charged, buyer payable, self-assessed and value-added reverse charge taxes, as well as multiple levels of jurisdictions. SAP Ariba solutions provide c