|By PR Newswire||
|January 16, 2013 07:01 AM EST||
MAIDENHEAD, England, January 16, 2013 /PRNewswire/ --
HUMIRA® (adalimumab) is the first biologic treatment in more than five years to be approved in the European Union for the treatment of severe active paediatric Crohn's disease offering at-home administration after suitable training,
AbbVie announced today that HUMIRA® (adalimumab) is now available for the treatment of paediatric patients aged six to 17 years with severe active Crohn's disease (CD) who have had an inadequate response to conventional therapy including primary nutrition therapy, a corticosteroid, and an immunomodulator, or who are intolerant to or have contraindications to such therapies. 
"Paediatric Crohn's disease is a chronic bowel disease that may have a significant impact on a child or young person and his or her family's quality of life," said Dr Richard Russell, Consultant Paediatric Gastroenterologist, Royal Hospital for Sick Children, Glasgow. "The number of children and young people diagnosed with Crohn's disease continues to rise in the UK but the number of treatment options available remains limited. For patients who do not respond to standard therapies, this new treatment option addresses a significant unmet need by offering the flexibility of out of hospital injectable administration, usually by patients or their parents."
Paediatric Crohn's disease is a chronic condition of the gastrointestinal (GI) tract. In the UK there are currently around 90,000 people living with Crohn's disease, which can affect people of all ages, including children.
As a type of inflammatory bowel disease, it most commonly involves the end of the small intestine and the beginning of the large intestine. In addition to symptoms such as abdominal pain, weight loss and diarrhoea, paediatric Crohn's disease can affect children in several ways unique to this age group, including delayed growth and/or puberty.
Richard Driscoll, Chief Executive of Crohn's and Colitis UK a charity which provides information, support and research for people of all ages affected by inflammatory bowel disease, said "Paediatric Crohn's disease is known to be increasing in frequency among children and young adults of all ages. We welcome this new treatment that is being made available in the UK as the symptoms can be very severe and have a significant debilitating effect on the child and their family."
"Whilst the psychological effects cannot be measured, symptoms, treatment and side effects may mean that childhood and adolescence can be severely disrupted making it difficult for some children to cope emotionally. Physical growth and pubertal development can be delayed, creating an additional problem, particularly in relation to school, college and social life" said Rod Mitchell, Chairman of the Crohn's in Childhood Research Association (CICRA).
Notes to editors
HUMIRA® (adalimumab) is a prescription medicine licenced for the treatment of moderate to severe active rheumatoid arthritis, active polyarticular juvenile idiopathic arthritis, active and progressive psoriatic arthritis, severe active ankylosing spondylitis (AS), severe axial spondyloarthritis without radiographic evidence of AS, moderately to severely active Crohn's disease and ulcerative colitis in adults, severe active Crohn's disease in paediatric patients, and moderate to severe chronic plaque psoriasis. Please refer to the Humira Summary of Product Characteristics (SmPC) for full product information which can be found at http://www.medicines.org.uk.
Adverse events should be reported. Reporting forms and information can be found at http://yellowcard.mhra.gov.uk/. Adverse events should also be reported to AbbVie Ltd on +44-(0)1628-774933.
AbbVie (NYSE:ABBV) is a global, research-based biopharmaceutical company formed in 2013 following separation from Abbott. AbbVie combines the focus and passion of a leading-edge biotech with the expertise and structure of a long-established pharmaceutical leader. The company's mission is to use its expertise, dedicated people and unique approach to innovation to develop and market advanced therapies that address some of the world's most complex and serious diseases. AbbVie aims to help patients live healthier lives and collaborate on sustainable healthcare solutions. In 2013, AbbVie will employ approximately 23,000 people worldwide and markets medicines in more than 170 countries. For further information on the company and its people, portfolio and commitments, please visit http://www.abbvie.co.uk
1. Humira Summary of Product Characteristics accessed via http://www.medicines.org.uk
2. European Medicines Agency. Scientific discussion. 2007. Available from: http://www.rcplondon.ac.uk/sites/default/files/documents/national-paediatric-uk-ibd-inpatient-care-audit-report-round-3_0.pdf Last accessed December 2012
3. NHS CHOICES. Crohn's disease. Available from: http://www.nhs.uk/conditions/crohns-disease/Pages/Introduction.aspx Last accessed December 2012
4. Mackner, L (2003). "Review: Psychosocial Issues in Pediatric Inflammatory Bowel Disease" J. Pediatr Psychol. 29 (4): 243-257
Palerra, the cloud security automation company, announced enhanced support for Amazon AWS, allowing IT security and DevOps teams to automate activity and configuration monitoring, anomaly detection, and orchestrated remediation, thereby meeting compliance mandates within complex infrastructure deployments. "Monitoring and threat detection for AWS is a non-trivial task. While Amazon's flexible environment facilitates successful DevOps implementations, it adds another layer, which can become a ...
Jul. 27, 2015 10:15 PM EDT Reads: 266
The speed of software changes in growing and large scale rapid-paced DevOps environments presents a challenge for continuous testing. Many organizations struggle to get this right. Practices that work for small scale continuous testing may not be sufficient as the requirements grow. In his session at DevOps Summit, Marc Hornbeek, Sr. Solutions Architect of DevOps continuous test solutions at Spirent Communications, explained the best practices of continuous testing at high scale, which is rele...
Jul. 27, 2015 10:00 PM EDT Reads: 1,314
"We got started as search consultants. On the services side of the business we have help organizations save time and save money when they hit issues that everyone more or less hits when their data grows," noted Otis Gospodnetić, Founder of Sematext, in this SYS-CON.tv interview at @DevOpsSummit, held June 9-11, 2015, at the Javits Center in New York City.
Jul. 27, 2015 09:45 PM EDT Reads: 968
Growth hacking is common for startups to make unheard-of progress in building their business. Career Hacks can help Geek Girls and those who support them (yes, that's you too, Dad!) to excel in this typically male-dominated world. Get ready to learn the facts: Is there a bias against women in the tech / developer communities? Why are women 50% of the workforce, but hold only 24% of the STEM or IT positions? Some beginnings of what to do about it! In her Opening Keynote at 16th Cloud Expo, S...
Jul. 27, 2015 09:00 PM EDT Reads: 2,024
With SaaS use rampant across organizations, how can IT departments track company data and maintain security? More and more departments are commissioning their own solutions and bypassing IT. A cloud environment is amorphous and powerful, allowing you to set up solutions for all of your user needs: document sharing and collaboration, mobile access, e-mail, even industry-specific applications. In his session at 16th Cloud Expo, Shawn Mills, President and a founder of Green House Data, discussed h...
Jul. 27, 2015 08:45 PM EDT Reads: 180
Delphix, the market leader in Data as a Service (DaaS), has been announced winner of the DevOps Solution Award at the prestigious Computing Vendor Excellence Awards in London. The awards celebrate the achievements of the technology vendors and service providers that are leading the field of enterprise IT. Delphix was recognised as the vendor demonstrating the most effective support of DevOps culture for its ability to improve time to market and collaboration between teams.
Jul. 27, 2015 08:00 PM EDT Reads: 255
"Our biggest growth area has been the security services, the managed services - the things that differentiate us in the market that there is no client that's too small and there's no client that's too big," explained Paul Mazzucco, Chief Security Officer at TierPoint, in this SYS-CON.tv interview at 16th Cloud Expo, held June 9-11, 2015, at the Javits Center in New York City.
Jul. 27, 2015 06:30 PM EDT Reads: 304
The Cloud industry has moved from being more than just being able to provide infrastructure and management services on the Cloud. Enter a new era of Cloud computing where monetization’s services through the Cloud are an essential piece of strategy to feed your organizations bottom-line, your revenue and Profitability. In their session at 16th Cloud Expo, Ermanno Bonifazi, CEO & Founder of Solgenia, and Ian Khan, Global Strategic Positioning & Brand Manager at Solgenia, discussed how to easily o...
Jul. 27, 2015 06:00 PM EDT Reads: 330
"We've just seen a huge influx of new partners coming into our ecosystem, and partners building unique offerings on top of our API set," explained Seth Bostock, Chief Executive Officer at IndependenceIT, in this SYS-CON.tv interview at 16th Cloud Expo, held June 9-11, 2015, at the Javits Center in New York City.
Jul. 27, 2015 06:00 PM EDT Reads: 515
Explosive growth in connected devices. Enormous amounts of data for collection and analysis. Critical use of data for split-second decision making and actionable information. All three are factors in making the Internet of Things a reality. Yet, any one factor would have an IT organization pondering its infrastructure strategy. How should your organization enhance its IT framework to enable an Internet of Things implementation? In his session at @ThingsExpo, James Kirkland, Red Hat's Chief Arch...
Jul. 27, 2015 05:30 PM EDT Reads: 1,330
Sysdig has announced two significant milestones in its mission to bring infrastructure and application monitoring to the world of containers and microservices: a $10.7 million Series A funding led by Accel and Bain Capital Ventures (BCV); and the general availability of Sysdig Cloud, the first monitoring, alerting, and troubleshooting platform specializing in container visibility, which is already used by more than 30 enterprise customers. The funding will be used to drive adoption of Sysdig Clo...
Jul. 27, 2015 05:00 PM EDT Reads: 399
The Software Defined Data Center (SDDC), which enables organizations to seamlessly run in a hybrid cloud model (public + private cloud), is here to stay. IDC estimates that the software-defined networking market will be valued at $3.7 billion by 2016. Security is a key component and benefit of the SDDC, and offers an opportunity to build security 'from the ground up' and weave it into the environment from day one. In his session at 16th Cloud Expo, Reuven Harrison, CTO and Co-Founder of Tufin,...
Jul. 27, 2015 03:00 PM EDT Reads: 427
The Internet of Things is not only adding billions of sensors and billions of terabytes to the Internet. It is also forcing a fundamental change in the way we envision Information Technology. For the first time, more data is being created by devices at the edge of the Internet rather than from centralized systems. What does this mean for today's IT professional? In this Power Panel at @ThingsExpo, moderated by Conference Chair Roger Strukhoff, panelists addressed this very serious issue of pro...
Jul. 27, 2015 03:00 PM EDT Reads: 1,221
"We do data integration for B2B also application to application, and we do data management and enable Big Data," explained Pat Adamiak, Vice President, Product Marketing at Liaison Technologies, in this SYS-CON.tv interview at 16th Cloud Expo, held June 9-11, 2015, at the Javits Center in New York City.
Jul. 27, 2015 03:00 PM EDT Reads: 299
"We specialize in testing. DevOps is all about continuous delivery and accelerating the delivery pipeline and there is no continuous delivery without testing," noted Marc Hornbeek, Sr. Solutions Architect at Spirent Communications, in this SYS-CON.tv interview at @DevOpsSummit, held June 9-11, 2015, at the Javits Center in New York City.
Jul. 27, 2015 02:45 PM EDT Reads: 321