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^[1],[2]

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. ^[1]

"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.^[3]

As a type of inflammatory bowel disease, it most commonly involves the end of the small intestine and the beginning of the large intestine.^[3] 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.^[4]

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

About HUMIRA^[1]

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.

About AbbVie

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