News Article | May 9, 2017
REDWOOD CITY, Calif., May 9, 2017 /PRNewswire/ -- C2 Therapeutics marked Digestive Disease Week by releasing the results of clinical studies that help further validate the utility of the C2 CryoBalloon® Ablation System (CbAS) for ablation of Barrett's esophagus.i These include studies that suggest a shorter physician learning curve with CbAS than for radiofrequency ablation (RFA) therapy and less pain two days post-procedure than with RFA. Further studies demonstrate potential for CbAS in ablation of gastric antral vascular ectasia (GAVE) and esophageal squamous cell neoplasia (ESCN). The CbAS is similar to RFA in being deployed with an endoscopic catheter but uses extreme cold instead of heat to destroy diseased tissue in the esophagus. In a procedure known as cryoballoon ablation, nitrous oxide (N 0) cryogen is delivered through a handheld controller in combination with a self-sizing balloon catheter that is inserted into the working channel of a 3.7 mm therapeutic endoscope. The CbAS has been used in nearly 900 procedures to date. The synopses of the study results released for Digestive Disease Week are: Physician Learning Curve. Studies show that physicians must perform about 30 RFA procedures to overcome the effect of learning curve on treatment outcomes.1 This study aimed to determine the learning threshold for ablation of Barrett's esophagus with the CbAS. The researchers analyzed prospectively collected cryoablation procedure data from patients with neoplastic Barrett's esophagus treated at a single academic institution. They concluded that the learning curve effect for CbAS is reached at about 18 cases, after which efficiency plateaus. Patient Experience. Two studies in the Netherlands2 compared post-procedural pain in 79 Barrett's esophagus patients treated with RFA patients and 20 treated with focal cryoballoon ablation. In both studies, all visible Barrett's esophagus was treated, including circumferential treatment of the gastroesophageal junction. Pain was assessed immediately after the procedures and by telephone on Day 2. Patients were asked to apply pain scores from zero (no pain) to 10 (worst pain possible). Immediately after the procedure, 53% of cryoballoon ablation patients reported severe pain (score greater than 3), versus 24% of RFA patients. However, on Day 2, 46% of RFA patients reported severe pain, versus 18% of cryoballoon ablation patients. "This could suggest a shortened pain course after cryoballoon ablation compared with RFA," said the principal investigator Prof. Bas Weusten, Gastroenterology & Hepatology, St. Antonius Hospital, Nieuwegein, Netherlands. Treatment for ESCN. Esophageal squamous cell cancer arises from esophageal squamous cell neoplasia (ESCN) and is highly lethal. A multi-site study3 assessed the safety and efficacy of focal cryoballoon ablation for eradicating ESCN. Forty-two patients (98%) were successfully treated. Thirty-five of 40 patients (88%) had complete eradication of unstained lesions (USL) upon a single treatment session; five patients (12%) with persistent USL were successfully re-treated. Three developed superficial self-limited mucosal laceration upon balloon inflation; two of these were successfully treated three months later and one did not return. Dr. Gui-Qi Wang, Department of Endoscopy, Cancer Institute and Hospital Chinese Academy of Medical Sciences in Beijing, China stated, "Although longer-term follow-up data is pending, early results of our multicenter study suggest that focal cryoballoon ablation is safe, well-tolerated and highly effective in inducing complete endoscopic and histologic response." Treatment for GAVE. GAVE is an uncommon cause of upper gastrointestinal bleeding. Endoscopic management has been mainly thermoablative, but balloon cryoablation is emerging as an alternative. This multi-center study4 reviewed data from 10 patients with refractory GAVE who were treated with balloon cryotherapy. These were patients who continued to receive treatment for GAVE despite prior non-cryoballoon therapy. Each patient received one to four cryoballoon treatments (median two). Technical success was achieved in all patients. Follow-up endoscopy showed improvement in eight patients; one patient showed no improvement in the three months post-cryotherapy. No adverse events were reported. "Cryoballoon therapy is a feasible and safe modality that can be used to treat GAVE," reports Dr. Amrita Sethi, Division of Digestive and Liver Disease, Columbia University Medical Center, New York, NY. "Further studies are needed to evaluate long-term outcomes for this modality and to compare results to standard therapies." Swipe Cryoballoon Ablation Technique. Ablation devices for dysplastic Barrett's esophagus are effective, but none offer the attributes for widespread adoption because of length of procedure time and ease of use. Other factors include side effects and lack of predictability of ablation depth. This multi-center study5 evaluated the safety, feasibility and dose response of a novel swipe balloon catheter developed by C2 Therapeutics (to be marketed as the C2 CryoBalloon® 90 Ablation System), which delivers 3 cm of ablation in less than 60 seconds. The technique was tested in domestic swine and six human patients. The swipe technique delivered uniform and predictable ablation with mucosal and submucosal necrosis in animal and human esophagus. All the animals tolerated the ablations without difficulty and were able to eat and gain weight afterward. The human patients also tolerated the procedure without adverse events. Investigators concluded that because of its ease of use, the device merits further clinical study in treating dysplastic Barrett's esophagus. "These studies reinforce C2 Therapeutics' commitment to improving treatment for patients affected by Barrett's esophagus and other diseases of the gastrointestinal system," said Peter Garcia-Meza, President and CEO. "We continue to develop new design configurations to treat unmet needs in patients with diverse anatomy and disease characteristics. We sincerely appreciate the dedication and support of our collaborating study investigators and participating trial centers." Barrett's esophagus develops as a result of chronic injury from gastroesophageal reflux disease (GERD). Over time, the normal esophageal lining is replaced with abnormal cells (Barrett's esophagus), putting patients at greater risk of developing cancer of the esophagus. Founded in 2007 and headquartered in Redwood City, California, C2 Therapeutics developed the C2 CryoBalloon® Ablation System for use as a cryosurgical tool in the field of general surgery, specifically for endoscopic applications, to include ablation of Barrett's esophagus with dysplasia. Acquired by PENTAX Medical – a division of HOYA Group – in January 2017, C2 Therapeutics continues to innovate and enhance its C2 CryoBalloon® Ablation System as a new standard for simplicity in the eradication of esophageal disease. For more information about C2 Therapeutics, please visit www.c2therapeutics.com. 1 George Kunnackal John, et al, Cryoballoon Ablation for Barrett's Esophagus: A Prospective Single Operator Learning Curve and Time-Efﬁciency Study, TU1170, AB560 GASTROINTESTINAL ENDOSCOPY Volume 85, No. 5S, 2017. 2 Sanne N. van Munster, et al, Post-Procedure Pain Associated with Endoscopic Ablation Therapy of Barrett's Esophagus: Post-Hoc Comparison Between Radiofrequency Ablation and Cryoballoon Ablation, TU1186, AB560 GASTROINTESTINAL ENDOSCOPY Volume 85, No. 5S, 2017. 3 Yan Ke, et al, Safety and Efficacy of Endoscopic Focal Cryoballoon Ablation for the Treatment of Esophageal Squamous Cell Intraepithelial Neoplasia, M01997, AB560 GASTROINTESTINAL ENDOSCOPY Volume 85, No. 5S, 2017. 4 Anish Patel, et al, Endoscopic Management of Refractory Gastric Antral Vascular Ectasia (GAVE) with Cryoballoon Therapy: A Case Series, MO1986, AB560 GASTROINTESTINAL ENDOSCOPY Volume 85, No. 5S, 2017. 5 Brian E. Louie, et al, Evaluation of a Novel Swipe Cryoballoon Ablation System in Bench, Porcine, and Human Esophagus, MO2010, AB560 GASTROINTESTINAL ENDOSCOPY Volume 85, No. 5S, 2017. i C2 CryoBalloon Focal Ablation System is intended for use as a cryosurgical tool in the field of general surgery, specifically for endoscopic applications, to include ablation of Barrett's esophagus with dysplasia.
News Article | May 9, 2017
News Article | May 11, 2017
The low oxygen concentrations that prevail in many tumors enhance their propensity to metastasize to other tissues. Researchers at Ludwig-Maximilians-Universitaet (LMU) in Munich led by Professor Heiko Hermeking have now uncovered the molecular mechanism that links the two phenomena. Many actively growing tumors are poorly supplied with blood, which limits the concentration of oxygen available within the tumor, a condition known as hypoxia. Tumor hypoxia has several significant consequences: The relative lack of oxygen partly accounts for the fact that such solid tumors are comparatively resistant to radiation and chemotherapy, and it also promotes the formation of satellite tumors in other tissues. Now researchers led by LMU professor Heiko Hermeking have dissected the mechanisms responsible for the association between tumor hypoxia and metastasis. Their results reveal how hypoxia leads to inhibition of the synthesis of a short RNA molecule that normally suppresses tumorigenesis. The new findings appear in the journal Gastroenterology. Cancers can only develop if the biochemical circuits that control cell proliferation and behavior are inactivated. These safe-guarding mechanisms are mediated by so-called tumor-suppressor proteins, one of which is known as p53. The gene encoding p53 is inactivated in more than half of all tumors. In previous studies Hermeking had shown that p53 induces the transcription of a short RNA - referred to as microRNA-34a (miR-34a) - which plays a central role in tumor suppression. "We observed that, in patients with colon carcinomas, the gene for miR-34a is very frequently inactivated in metastasizing tumors, which are often characterized by relative oxygen deficiency," Hermeking says. He and his colleagues have now shown that, in tumor cells in which the p53 function is compromised, complete loss of miR-34a expression is a direct consequence of hypoxia. In response to low oxygen levels, the tumor cells trigger the synthesis of hypoxia-inducible factor 1a (HIF1a), a protein that directly represses the transcription of miR-34a. Furthermore, this down-regulation of the microRNA is a prerequisite for hypoxia-induced epithelial-to-mesenchymal transition (EMT). In this process, HIF1a activates a genetic program that results in the transformation of non-invasive cells (which grow in a regulated fashion in epithelial sheets) into invasive, migratory cells that can seed new tumors elsewhere. EMTs play important roles in embryonic development and organogenesis, as well as in wound healing, but must be tightly regulated. Among the proteins involved in orchestrating the EMT is PPP1R11. Hermeking's team found that especially high levels of this protein are synthesized in the cells that form the leading edge of an invasive tumor - where the oxygen concentration is expected to be particularly low. In normal cells, on the other hand, the production of PPP1R11 is repressed directly by miR-34a and thus indirectly by the tumor suppressor p53. This ensures that cells divide in a coordinated manner and prevents formation of metastases. "The regulatory antagonism is presumably the reason why metastasizing tumor cells are selected for loss of the p53 gene, which is required for the expression of miR-34a," Hermeking explains. The new findings also have therapeutic implications, for they suggest that metastasizing colon tumors could perhaps be treated with drugs that inhibit the functions of proteins that promote the EMT. Such inhibitors would also be expected to permit reactivation of the expression of miR-34a. "In fact, molecules that act as functional substitutes for miR-34a are now being tested in clinical trials," says Hermeking. This miRNA is of particular interest as a drug target, because it is involved in the control of many regulatory processes. For instance, reintroduction of miR-34a into tumor cells also activates the patient's immune system to attack the tumor. Hermeking's results suggest that hypoxic tumors might be especially susceptible to this approach.
News Article | May 9, 2017
The analysis of more than 225,000 healthcare and medical job postings placed by 6,377 hospitals and healthcare organizations on Health eCareers during 2016 also reveals other encouraging trends such as the physician specialties with the most growth, the top 10 most in-demand non-physician positions, and other notable growth spots within the industry. The Physician Specialties with the Most Growth A whopping 53 percent of job postings on Health eCareers in 2016 were for physicians and surgeons, a 20 percent increase over 2015. Under the physician heading, the specialties with the most growth were Family Medicine, OB/GYN, and Gastroenterology. In today's highly competitive market, healthcare organizations are also adding a number of incentives to their physician contracts. According to the report, health, malpractice, and disability insurance are the three most common physician-recruitment incentives, although relocation expenses and signing bonuses are becoming more common as well. The Top 10 Most In-Demand Non-Physician Positions Nurses, Nurse Practitioners (NPs) and Physician Assistants (PAs) accounted for 31 percent of job postings on Health eCareers in 2016, with employers advertising more than 70,000 positions for these roles. Within Nursing, 75 percent of postings were for Registered Nurses, with General Medical/Surgical and Emergency Room Nurses being most in demand. Family Medicine topped the list for both PAs and NPs. The report concluded that, since U.S. states are easing practice laws for PAs and NPs, patients can expect more access to them in the future, along with expanded telemedicine options. Other Notable Growth Spots Physicians and nurses are not the only healthcare occupations enjoying continued growth. U.S. News and World Report recently ranked the top 100 jobs for 2017 and discovered that 21 of the top 25 spots (including the top three) belong to healthcare-related positions. Dentist, NP and PA are the top three; other top-25 healthcare positions include: Nurse Anesthetist (#6), Pediatrician (#7), Optometrist (#11), Midwife (#15), Registered Nurse (#22) and Occupational Therapist (#23). Conclusion Although Physician/Surgeon and Nursing positions continue to account for the majority of job postings on Health eCareers, all job seekers within the wide-ranging field of healthcare can be optimistic about 2017 and beyond. For more information on healthcare job trends, download the full 2016 Healthcare Jobs Snapshot. About the Survey The Health eCareers 2016 Healthcare Jobs Snapshot is based on data collected from the Health eCareers online database of job openings, which are placed by healthcare employers and recruiters all across the U.S. Data was collected from January 1 to December 31, 2016, and encompasses 225,529 healthcare and medical job postings placed by 6,377 hospital and healthcare organizations. These organizations range from large health systems to single-specialty practices, with an average hospital size of 300 beds. About Health eCareers Healthcare is all about connection, and Health eCareers is the healthcare industry's career hub for professionals, employers and associations. With a network of more than 2.4 million job seekers, thousands of healthcare employers and more than 100 exclusive association partners, Health eCareers is designed to match qualified healthcare professionals – from physicians and nurses to non-clinical staff – with medical providers looking for top talent. And with the addition of SHIFT, Health eCareers has also become the destination to find temporary healthcare work. But Health eCareers is more than just a place to look for your next job — it's a resource to help you advance your career at every stage. That's why Health eCareers also includes industry news and career advice targeted to your healthcare specialty. For employers, Health eCareers offers innovative recruiting tools and services and healthcare hiring data that you won't find anywhere else. To learn more, visit healthecareers.com or find us on Facebook and Twitter. Health eCareers is a DHI Group, Inc. service. To view the original version on PR Newswire, visit:http://www.prnewswire.com/news-releases/health-ecareers-predicts-healthcare-jobs-growth-in-2017-300453689.html
News Article | May 12, 2017
Dr Kwon, medisch directeur bij Celltrion Healthcare, verklaarde: “ De publicatie van de NOR-SWITCH-gegevens in The Lancet markeert opnieuw een belangrijke mijlpaal voor het vergroten van het vertrouwen van artsen om biosimilar infliximab te gebruiken als overwogen wordt om hun patiënten over te schakelen.” Na presentaties tijdens zowel de 2016 United European Gastroenterology (UEG) Week als de jaarlijkse bijeenkomst van het American College of Rheumatology (ACR) bleek uit de bevindingen van de studie dat van de 50% van de patiënten die overgeschakeld waren naar CT-P13, het percentage patiënten met verslechtering van de ziekte vergelijkbaar was met die patiënten die referentie infliximab bleven gebruiken (respectievelijk 29,6 en 26,2%). De datadiscontinueringspercentages door een gebrek aan werkzaamheid voor referentie infliximab en biosimilar infliximab waren respectievelijk acht en drie. De tijd om de stopzetting van de medicijnen te onderzoeken was bijna identiek tussen de twee groepen, waarbij ook vergelijkbare totale remissiecijfers en frequenties van bijwerkingen waargenomen werden. 1 CP-P13 is ontwikkeld en geproduceerd door Celltrion, Inc. en was 's werelds eerste monoklonaal antilichaam-biosimilar dat werd goedgekeurd door het Europees Geneesmiddelenbureau (EMA). Het is geïndiceerd voor de behandeling van acht auto-immuunziekten zoals reumatoïde artritis en inflammatoire darmziekte. Het werd in september 2013 door de EMA goedgekeurd onder de handelsnaam Remsima® goedgekeurd en begin 2015 gelanceerd in Europa. De Amerikaanse FDA keurde Celltrion's CT-P13 goed in april 2016 onder de handelsnaam Inflectra™. Celltrion's CT-P13 is goedgekeurd in meer dan 79 (vanaf januari 2017) landen, waaronder de VS, Canada, Japan en heel Europa. Celltrion Healthcare voert wereldwijde marketing, verkoop en distributie van biologische geneesmiddelen ontwikkeld door Celltrion, Inc. uit via een uitgebreid wereldwijd netwerk dat meer dan 120 verschillende landen bestrijkt. De producten van Celltrion Healthcare worden gemaakt in state-of-the-art faciliteiten voor zoogdiercelcultuur, ontworpen en gebouwd om te voldoen aan de Amerikaanse cGMP-normen van de FDA en de GMP-normen van de EU. Voor meer informatie kunt u terecht op: http://www.celltrionhealthcare.com/ The Lancet is een van 's werelds grootste onafhankelijke algemene medische tijdschriften. Het intercollegiaal getoetste tijdschrift publiceert medisch nieuws en origineel onderzoek en biedt evaluaties over alle aspecten van klinische geneeskunde en internationale gezondheid. The Lancet heeft een impactfactor van 44,002. 1 Jørgensen, K. et al. Switching from originator infliximab to biosimilar CT-P13 compared with maintained treatment with originator infliximab (NOR-SWITCH): a 52-week, randomised, double-blind, non-inferiority trial. The Lancet, beschikbaar op: http://dx.doi.org/10.1016/S0140-6736(17)30068-5 [geraadpleegd in mei 2017]. Deze bekendmaking is officieel geldend in de originele brontaal. Vertalingen zijn slechts als leeshulp bedoeld en moeten worden vergeleken met de tekst in de brontaal, die als enige rechtsgeldig is.
News Article | May 10, 2017
Paul J. Thuluvath, M.D., Medical Director for The Melissa L. Posner Institute for Digestive Health & Liver Disease, Chief of the Division of Gastroenterology, and head of The Center for Liver and Hepatobiliary Diseases at Mercy Medical Center, is encouraging the Maryland health care community to raise awareness about hepatitis C (HCV) and hepatitis C screening in light of recent Centers for Disease Control (CDC) recommendations about the disease. Mercy will be conducting a special digital public awareness campaign to encourage hepatitis C screening throughout the month of May which is National Hepatitis Awareness Month. “The CDC recommends that adults born 1945-1965—the “baby boomers”-- should receive one-time testing without prior ascertainment of HCV risk. In addition, all adults who are at risk for HCV infection, such as injection drug users and needle stick injuries, should be tested. Despite these recommendations, too few American baby boomers are being tested for hepatitis C,” Dr. Thuluvath said. “Of the estimated 3.5 million Americans who have the virus, 80 percent are baby boomers. Left untreated, hepatitis C can cause cirrhosis of the liver, liver cancer, and lead to death. Because hepatitis C is often a silent illness, with few symptoms, many with this contagious liver disease don’t even know they have it. May is National Hepatitis C Awareness Month, so an ideal time to emphasize education about HCV, its diagnosis and treatment,” Dr. Thuluvath added. “The hepatitis C virus, thanks to new clinical breakthroughs, is now a curable disease. But that cure can only be achieved if patients are tested, to know whether or not they have the virus,” Dr. Thuluvath concluded. “I’m very pleased to see others join our administration in helping educate the community about the risks associated with hepatitis C,” said Maryland Governor Larry Hogan. Gov. Hogan has been a strong supporter of health care education and initiatives, from his creation of the Maryland Heroin and Opioid Emergency Task Force and efforts to expand the state’s Good Samaritan Law and Prescription Drug Monitoring Program. “The Baltimore City Health Department has made considerable efforts to provide citizens with important information about the hepatitis C virus. We applaud the efforts of all those in the medical community who are working hard to beat hepatitis C,” said Baltimore City Mayor Catherine E. Pugh. Mayor Pugh has long been an advocate of health care education, authoring a series of children’s books advocating exercise and healthy eating, founding the celebrated annual runners’ event, the Baltimore Marathon, has been recognized as The Mental Health Associations Legislator of the Year, and more. Both Governor Hogan and Mayor Pugh cited how in 2014, the Baltimore City Health Department, the Maryland Department of Health and Mental Hygiene, the Johns Hopkins University School of Medicine, and the Baltimore County Health Department, received a multi-year grant from the Centers for Disease Control and Prevention to launch a regional initiative to expand HCV testing and treatment. People can contract the hepatitis C virus through contact with an infected person’s blood person. This may occur by sharing drug-injecting equipment, using cocaine, having sex, or getting a blood transfusion or organ transplant. It can also be spread by getting a tattoo with unsterile equipment. In rare cases, women with hepatitis C transmit the virus to their infants. Symptoms often do not develop until the disease is in its advanced stages and significant liver damage has already occurred. A world-renowned hepatologist, Dr. Paul Thuluvath provides patients with pioneering treatments and advanced technology to help them manage their illness. Dr. Thuluvath is also author of Hepatitis C: A Complete Guide for Patients and Families, a comprehensive guide to hepatitis C. He is a recognized national and international authority in liver and biliary diseases and dedicated to medical research and clinical trials that are advancing treatment possibilities for patients. Mercy Medical Center is a 143-year-old, university affiliated medical facility with a national reputation for women’s health care. Mercy is home to the acclaimed Weinberg Center for Women’s Health & Medicine and the $400+ million Mary Catherine Bunting Center. For more information, visit http://www.mdmercy.com, MDMercyMedia on Facebook and Twitter, or call 1-800-MD-Mercy.
News Article | May 12, 2017
INCHEON, South Korea--(BUSINESS WIRE)--Detailed results from NOR-SWITCH, a randomized, double-blind, switching study of biosimilar infliximab, CT-P13 (Remsima®/ Inflectra™) were published in the prestigious journal The Lancet. Sponsored by the Norwegian government, the study explored the impact of switching adult patients who were stable on reference infliximab to Celltrion Healthcare’s biosimilar CT-P13. The results demonstrate that CT-P13 is not inferior to continued treatment with the reference product and that patients can be safely switched. 1 Dr Kwon, Medical Director at Celltrion Healthcare said: “ The publication of the NOR-SWITCH data in The Lancet marks another important milestone on the path to increasing physician confidence in using biosimilar infliximab when looking to switch their patients.” Following presentations at both the 2016 United European Gastroenterology (UEG) Week and the American College of Rheumatology (ACR) Annual Meeting, the findings from the study revealed that out of the 50% of patients switched to CT-P13, the proportion of patients with disease worsening were comparable to those who remained on reference infliximab (29.6 and 26.2% respectively.) The data discontinuation rates due to a lack of efficacy for reference infliximab and biosimilar infliximab were eight and three respectively. The time to study drug discontinuation was almost identical between the two groups, with similar overall remission rates and frequencies of adverse events also observed. 1 Tore K. Kvien, Head of Department of Rheumatology, Diakonhjemmet Hospital, Oslo, Norway, and the lead author of the NOR-SWITCH study, also said: “ NOR-SWITCH results show that efficacy and safety were comparable between patients switched to CT-P13 and those who continued treatment with reference infliximab, proving that patients can be safely switched to CT-P13. As the data are specific to CT-P13, we must be clear that these findings can only apply to this particular biosimilar.” The Norwegian government wanted to determine the impact of switching adult patients who were stable on reference infliximab to biosimilar (CT-P13), and funded NOR-SWITCH to evaluate this across all inflammatory diseases for which infliximab is approved (Crohn’s disease, ulcerative colitis, rheumatoid arthritis, spondyloarthritis, psoriatic arthritis or chronic plaque psoriasis). Involving nearly 500 patients, the study was designed by a multidisciplinary and multiregional project group with special competence in performance of strategy trials, immunogenicity, and statistics led by Professor Tore Kvien at the Department of Rheumatology, Diakonhjemmet Hospital, Oslo, Norway. Additionally, the group consisted of representatives from the three relevant patient organisations.2 CT-P13 is developed and manufactured by Celltrion, Inc. and was the world’s first monoclonal antibody biosimilar approved by the European Medicines Agency (EMA). It is indicated for the treatment of eight autoimmune diseases including rheumatoid arthritis and inflammatory bowel disease. It was approved by the EMA under the trade name Remsima® in September 2013 and launched in Europe in early 2015. The US FDA approved Celltrion’s CT-P13 in April 2016 under the trade name Inflectra™. Celltrion’s CT-P13 is approved in more than 79 (as of January 2017) countries including the US, Canada, Japan and throughout Europe. 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/ The Lancet is one of the world's leading independent general medical journal. The peer-reviewed journal publishes medical news, original research, and reviews on all aspects of clinical medicine and International Health. The Lancet has an Impact Factor of 44.002. 1 Jørgensen, K. et al. Switching from originator infliximab to biosimilar CT-P13 compared with maintained treatment with originator infliximab (NOR-SWITCH): a 52-week, randomised, double-blind, non-inferiority trial. The Lancet, Available at: http://dx.doi.org/10.1016/S0140-6736(17)30068-5 [accessed May 2017]. 2 GAFPA. NOR-SWITCH. Available at: http://1yh21u3cjptv3xjder1dco9mx5s.wpengine.netdna-cdn.com/wp-content/uploads/2016/09/GAfPA_Norswitch_Sept.-2016.pdf [accessed May 2017].
News Article | May 12, 2017
Sponsorizzato dal governo norvegese, lo studio ha esplorato l’impatto del passaggio al biosimilare infliximab CT-P13 di Celltrion Healthcare nei pazienti adulti in condizioni stabili trattati con il prodotto originale infliximab. I dati dimostrano che CT-P13 non è inferiore al trattamento continuativo con infliximab originale e che i pazienti possono passare da una terapia all'altra in tutta sicurezza. 1 A seguito di presentazioni tenutesi in occasione della 2016 United European Gastroenterology (UEG) Week e dell’incontro annuale dell’American College of Rheumatology (ACR), i dati dello studio hanno rivelato che nel 50% di pazienti passati a CT-P13, la proporzione di pazienti che hanno dimostrato un peggioramento della malattia era paragonabile a quelli che continuavano ad essere trattati con infliximab originale (29,6 e 26,2%, rispettivamente). I tassi di sospensione dei dati dovuta ad una mancanza di efficacia per infliximab orginale e infliximab biosimilare erano pari a otto e tre, rispettivamente. È risultato inoltre che il tempo necessario per studiare la sospensione del farmaco sperimentale era quasi identico per entrambi i gruppi, con simili tassi di remissione e frequenza di eventi avversi complessivi. 1 Il Professor Tore Kvien, responsabile del dipartimento di reumatologia del Diakonhjemmet Hospital di Oslo, in Norvegia, e responsabile dello studio NOR-SWITCH, ha inoltre dichiarato: “ I risultati di NOR-SWITCH mostrano che la sicurezza e l’efficacia erano paragonabili fra pazienti che sono passati a CT-P13 e quelli che continuavano il trattamento con infliximab originale, provando che i pazienti possono passare a CT-P13 in tutta sicurezza. Va tuttavia ricordato che questi dati si riferiscono specificamente a CT-P13 e non sono trasferibili ad altri biosimilari”. Per determinare l’impatto del passaggio al biosimilare infliximab (CT-P13) nei pazienti adulti in condizioni stabili precedentemente trattati con il prodotto originale, il governo norvegese ha finanziato lo studio NOR-SWITCH per valutare questa opzione in tutte le patologie infiammatorie per le quali infliximab è approvato (morbo di Crohn, colite ulcerativa, artrite reumatoide, spondiloartrite, artrite psoriasica o psoriasi cronica a placche). CT-P13, sviluppato e prodotto da Celltrion, Inc., è stato il primo anticorpo monoclonale biosimilare approvato dall'Agenzia europea per i medicinali (EMA). È indicato per il trattamento di otto malattie autoimmuni, inclusa l'artrite reumatoide e le malattie infiammatorie intestinali. Ha ricevuto l'approvazione dell'EMA con il nome commerciale Remsima® nel mese di settembre del 2013 ed è stato lanciato in Europa agli inizi del 2015. La FDA statunitense ha approvato CT-P13 di Celltron nel mese di aprile 2016 con il nome commerciale Inflectra™. CT-P13 di Celltron è approvato in oltre 79 paesi (dati aggiornati al mese di gennaio 2017) inclusi Stati Uniti, Canada, Giappone e tutta l'Europa. Celltrion Healthcare effettua a livello mondiale attività di marketing, vendita e distribuzione dei biofarmaci sviluppati da Celltrion, Inc. tramite un'estesa rete internazionale che comprende più di 120 paesi diversi. I prodotti di Celltrion Healthcare sono realizzati a partire da colture cellulari di mammiferi in avanzate strutture studiate e realizzate per la conformità agli standard cGMP della FDA statunitense e agli standard GMP della UE. Per ulteriori informazioni visitare il sito http://www.celltrionhealthcare.com/ 1 Jørgensen, K. et al. Switching from originator infliximab to biosimilar CT-P13 compared with maintained treatment with originator infliximab (NOR-SWITCH): a 52-week, randomised, double-blind, non-inferiority trial. The Lancet, Disponibile su: http://dx.doi.org/10.1016/S0140-6736(17)30068-5 [ultimo accesso maggio 2017].