Celltrion Healthcare Presents Phase III Switching Data Supporting the Long-Term Efficacy and Safety of Truxima® (CT-P10, Biosimilar Rituximab) in Rheumatoid Arthritis Patients
New data presented at the 2017 American College of Rheumatology (ACR) Annual Meeting show that CT-P10 is comparable to reference rituximab in terms of efficacy, pharmacodynamics (PD) and safety profile, over a sustained period of time after switching from reference rituximab in patients with rheumatoid arthritis (RA).1
A total of 295 patients participated in the extension period of the phase III, randomised controlled trial after completing treatment up to 48 weeks with CT-P10 or reference rituximab. Patients with RA in both groups during this main period demonstrated equivalent efficacy and similar pharmacokinetic (PK) and safety profiles.2
During the extension period, patients who previously received reference rituximab either maintained treatment or were switched to CT-P10. Efficacy, PD, safety and immunogenicity were evaluated for a further 24-weeks. CT-P10 showed long term effectiveness and tolerability throughout, and the DAS28-CRP improvement, ACR and EULAR response rates, all clinically recognised measurements of efficacy, were comparable between patients switched to CT-P10 and those in the maintained group.1
Professor Alten, Director of the Rheumatology Research Centre at the Teaching Hospital of the Charité, Berlin said: “In the field of rheumatology, whether to switch patients to biosimilars is a pressing question among physicians. Therefore, it is important to see results from studies such as this one, which shows comparable long-term efficacy and safety of CT-P10, a biosimilar for rituximab following switching.”
Man Hoon Kim, President and CEO of Celltrion Healthcare, said: “The study shows the comparability of our biosimilar rituximab, CT-P10, to the reference rituximab after switching over a sustained period of time. This adds to the increasing wealth of long-term data in support of CT-P10 in rheumatoid arthritis, demonstrating its continuous effective use, which should help physicians feel confident in switching their patients to this biosimilar rituximab.”
Notes to editors:
About CT-P10 (biosimilar rituximab)
CT-P10 is a monoclonal antibody that targets CD20, a transmembrane protein found on the surface of most B cells. By binding specifically to CD20, CT-P10 depletes B cells by three main mechanisms: Induction of apoptosis, Stimulation of CDC (complement-dependent cytotoxicity), Stimulation of ADCC (antibody-dependent cell-mediated cytotoxicity).
CT-P10 is approved in the EU for the treatment of patients with Non-Hodgkin lymphoma, chronic lymphocytic leukaemia, RA, granulomatosis with polyangiitis and microscopic polyangiitis. Further details of the approved indications and safety information for CT-P10 are available in the summary of product characteristics (SmPC).3
About rheumatoid arthritis
In Europe, more than 2.9 million people have rheumatoid arthritis (RA), many of whom are of working age. On average, every third person with RA becomes work disabled and up to 40 per cent leave work completely within 5 years of diagnosis.4 Although there is no cure for RA, there are many treatments that can reduce inflammation and ease pain. As with all rheumatic diseases early diagnosis and intervention is key.
About Celltrion Healthcare
Celltrion Healthcare conducts the worldwide marketing, sales and distribution of biological medicines developed by Celltrion, Inc. through an extensive global network that spans more than 120 different countries. Celltrion Healthcare’s products are manufactured at state-of-the-art mammalian cell culture facilities, designed and built to comply with the US Food and Drug Administration (FDA) cGMP guidelines and the EU GMP guidelines. For more information please visit: http://www.celltrionhealthcare.com/
1 Shim et al. Efficacy and safety of rituximab biosimilar,
CT-P10, after a single switch from innovator rituximabs in patients with
rheumatoid arthritis: Results from phase 3 randomised controlled trial
over 72 week. American College of Rheumatology (ACR). 2017. 2445.
2 Suh et al. Randomised double-blind study shows comparable long-term efficacy and safety between rituximab biosimilar CT-P10 and innovator rituximab in patients with rheumatoid arthritis: 48 week results. Annual European Congress of Rheumatology (EULAR). 2017. SAT0146
3 Truxima concentrate for solution for infusion summary of product characteristics [last accessed November 2017]. Available at http://www.ema.europa.eu/docs/en_GB/document_library/EPAR_-_Product_Information/human/004112/WC500222694.pdf.
4 NRAS, European Fit for Work Report. Available at www.nras.org.uk/european-fit-for-work-report. [Last accessed November 2017].
For more than 50 years, Business Wire has been the global leader in press release distribution and regulatory disclosure.
Tilaa tiedotteet sähköpostiisi
Haluatko tietää asioista jo ennen kuin ne uutisoidaan? Kun tilaat tiedotteemme, saat ne sähköpostiisi yhtä aikaa suomalaisen median kanssa. Tilauksen voit halutessasi perua milloin tahansa.
Lue lisää julkaisijalta Business Wire
Cushman & Wakefield To Acquire Its Irish Affiliate From Sherry FitzGerald Group16.7.2018 16:49 | Tiedote
Global real estate services firm Cushman & Wakefield today announces it has entered into a definitive agreement to acquire the commercial property arm of Sherry FitzGerald Group in the Republic of Ireland. The deal is expected to complete in early September 2018. Cushman & Wakefield already has a 20% stake in the Irish commercial property business which operated as its exclusive affiliate in the Republic – rebranding two years ago as Cushman & Wakefield Ireland. The firm, which has more than 100 commercial property professionals and offices in Dublin, Limerick and Galway, will now be fully integrated into Cushman & Wakefield, one of the world’s largest real estate services firms with 48,000 employees in approximately 400 offices and 70 countries. Managing Director Aidan Gavin becomes Cushman & Wakefield’s Head of Ireland and will also sit on the firm’s UK & Ireland Executive Committee. Cushman & Wakefield will maintain its close affiliate relationship with the wider Sherry FitzGerald G
Fischer & Schickendantz and Solution Alliance SRL Adopt Andersen Brand in Uruguay16.7.2018 16:30 | Tiedote
Fischer & Schickendantz, led by Juan Federico Fischer, and Solution Alliance SRL, led by Juan Ignacio Troccoli, have rebranded this week as Andersen Tax & Legal, a member firm of Andersen Global. The firm, based in Montevideo, entered a Collaboration Agreement with Andersen Global in September 2017, and is now a fully integrated member of the global verein. Juan Federico Fischer remarked, “Andersen is a symbol of quality and is recognized worldwide by both clients and professionals, and is ahead of the game in terms of creating a global firm with integrated tax and legal services. We are truly excited to officially be part of the team.” “Throughout their time with us as a collaborating firm and now a member firm, the team in Uruguay has demonstrated a deep commitment to providing seamless, best-in-class service. Additionally, Juan Federico is a member of Andersen Global’s Latin American regional board, and is the true embodiment of the values that our organization represents. I look fo
CALVIN KLEIN Fragrances Announces Lupita Nyong'o and Saoirse Ronan as Faces of CALVIN KLEIN WOMEN16.7.2018 14:00 | Tiedote
Calvin Klein, Inc., a wholly owned subsidiary of PVH Corp. [NYSE:PVH], and Calvin Klein Fragrances, a division of Coty Inc. [NYSE:COTY], today revealed the worldwide print advertising campaign for the new fragrance CALVIN KLEIN WOMEN , the first CALVIN KLEIN fragrance to be developed under the vision of Chief Creative Officer, Raf Simons. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20180716005092/en/ CALVIN KLEIN WOMEN The campaign features Lupita Nyong'o and Saoirse Ronan. Award-winning actors and voices of their generation, both women are universally recognized for their unique talent, creativity, intelligence and strength of character. Directed by artist Anne Collier with creative direction from Lloyd & Co., the campaign champions iconic women and celebrates heroines of contemporary culture. Lupita and Saoirse are featured in the print campaign, in a pair of striking and direct portraits, positioned next to chosen figure
Norsk Titanium Produces Space Demonstration Hardware16.7.2018 14:00 | Tiedote
Norsk Titanium (Norsk), the world’s first FAA-approved supplier of aerospace-grade, additive manufactured, structural titanium components, has produced an Expansion Nozzle demonstrator in support of the European Space Agency’s Technology Research Programme (TRP). The TRP is an European Space Agency (ESA) technology development effort supporting all of ESA’s fields of activity across the entire spectrum of technical disciplines, providing the technological nucleus for most future developments. Norsk was awarded a TRP contract with the ESA in 2014 to explore the application of Norsk’s Rapid Plasma Deposition™ (RPD™) process to space applications. Through the TRP contract, Norsk has refined its material characterization and quality assurance processes, while providing ESA valuable insight into the application of additive processes to their unique needs. The culmination of this effort was the production of an Expansion Nozzle demonstrator. The Expansion Nozzle utilizes the latest RPD™ desi
Bank of America Reports Second-Quarter 2018 Financial Results16.7.2018 13:45 | Tiedote
Bank of America reported its second-quarter 2018 financial results today. The news release, supplemental filing and investor presentation can be accessed in the following ways: This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20180716005280/en/ Bank of America newsroom at https://newsroom.bankofamerica.com Bank of America Investor Relations website at http://investor.bankofamerica.com Business Wire’s news webpage at http://www.businesswire.com/portal/site/home/news Investor Conference Call information Chief Executive Officer Brian Moynihan and Chief Financial Officer Paul Donofrio will discuss the financial results in a conference call at 8:30 a.m. ET today. For a listen-only connection to the conference call, dial 1.877.200.4456 (U.S.) or 1.785.424.1732 (international), and the conference ID is 79795. Please dial in 10 minutes prior to the start of the call. Investors can also listen to a live audio webcast of the conference ca
Bank of Singapore is the First Singapore Private Bank to Receive Regulatory Approval to Open a Wealth Management Subsidiary in Luxembourg16.7.2018 12:36 | Tiedote
Bank of Singapore today announced that it has been granted an investment company licence to operate a wealth management subsidiary in Luxembourg – a first for a Singapore private bank. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20180716005252/en/ (Photo: BOSWM) Bank of Singapore, through this new subsidiary, BOS Wealth Management Europe Société Anonyme (S.A.), will be able to offer a comprehensive range of customised private banking solutions and investment advisory services to its ultra-high and high net worth clients in the European Economic Area (“EEA”) and the United Kingdom (“UK”). The EEA comprises the European Union (EU) countries and Iceland, Liechtenstein and Norway. Currently, Bank of Singapore serves its European clients from its Singapore headquarters and through its parent company OCBC Bank’s London office. There has been robust growth in assets under management from EEA clients as they hold Singapore in high
Uutishuoneessa voit lukea tiedotteitamme ja muuta julkaisemaamme materiaalia. Löydät sieltä niin yhteyshenkilöidemme tiedot kuin vapaasti julkaistavissa olevia kuvia ja videoita. Uutishuoneessa voit nähdä myös sosiaalisen median sisältöjä. Kaikki STT Infossa julkaistu materiaali on vapaasti median käytettävissä.Tutustu uutishuoneeseemme