26 April 2017
Clinical trial discovers a new way to prevent children with arthritis and eye disease losing their sight
A trial funded by the charity Arthritis Research UK and the
National Institute for Health Research (NIHR) has discovered a drug
combination that could help thousands of children with
arthritis.
Over 5,000 children and adolescents with Juvenile Idiopathic
Arthritis (JIA) in the UK are likely to develop uveitis, a
condition that causes inflammation in the middle layer of the
eye. The drug combination discovery will help
preventing them from serious complications, including
blindness.
The trial was first of its kind in the world and the findings
are a major step forward for children with JIA. The drug therapy
has already been approved for use and the study is published today
in The New England Journal of Medicine.
The trial's Co-Chief Investigators, Professors A. V. Ramanan and
Michael Beresford, and colleagues from across the UK, found that a
drug called Adalimumab, in combination with Methotrexate, was an
effective therapy in children and adolescents with JIA-associated
uveitis. The majority (75 per cent) of those children treated with
Adalimumab experienced a significant reduction in eye
inflammation. An early analysis of the data was so convincing
that the trial was stopped early.
In this randomised, placebo controlled trial on review of 90 of
the target 149 patients with JIA-associated uveitis, the data and
safety monitoring committee noted that the Adalimumab group had
evidence of a significantly lower risk of treatment failure than
the placebo group.
This multi-centre trial involved extremely close collaboration
between paediatric rheumatology and ophthalmology colleagues across
the country and was sponsored by University Hospitals Bristol NHS
Foundation Trust, and co-ordinated by the Clinical Trials Research
Centre at the University of Liverpool. The trial outcomes directly
led to the changes in commissioning guidelines and resulted NHS
England approving the use of Adalimumab in children with uveitis
that threatens their sight, and for whom other treatments have
proven ineffective.
Professor RamananfromUniversity Hospitals Bristol NHS Foundation
Trust and University of Bristol said: "Uveitis in children is an
important cause of loss of vision. This study demonstrates the
benefit of Adalimumab in children with uveitis. This is the first
randomised trial of its kind worldwide and the results will have a
major impact in children with uveitis all around the world."
Professor Beresford from University of Liverpool and Alder Hey
Children's NHS Foundation Trust said: "This landmark trial has
demonstrated the commitment and leadership of colleagues across the
UK in working closely with patients and parents in tackling a key
priority of finding the very best way of caring for children with
arthritis and this serious problem of uveitis. It has shown the UK
to be extremely well placed to deliver challenging trials in
children, with the support of the NIHR Clinical Research Network
and other research networks that are in place across the UK."
There are 15,000 children and adolescents in the UK with the
auto-immune disease JIA. One third of those are likely to develop
uveitis, leading to more serious visual impairments and may be
registered as blind.
Stephen Simpson, director of research and programmes at
Arthritis Research UK said: "We are thrilled of the outcome of this
trial and the huge promise it heralds for transforming the quality
of life for the large numbers of children with JIA-associated
uveitis. This trial is an impressive example of how investing in
exceptional science can ultimately help change how treatment is
delivered with direct and immediate benefit for patients."
For further information, please contact Arthritis Research UK
via press@arthritisresearchuk.org
or 0300 7900456
About Arthritis Research UK
At Arthritis Research UK, we invest in breakthrough treatments,
the best information and vital support for everyone affected by
arthritis. We believe that by harnessing the power of exceptional
science we can overcome the pain, isolation and fatigue arthritis
causes, making everyday life better for all 10 million people with
arthritis in the UK.
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