PRESS RELEASE
NICE recommends the selective use of new drugs for arthritis in children and adults
The National Institute for Clinical Excellence (NICE or the Institute) has recommended the use of etanercept for the treatment of juvenile idiopathic arthritis (JIA) and etanercept and infliximab for rheumatoid arthritis (RA).Etanercept is recommended for children aged 4 to 17 years who have active JIA in at least five joints and whose condition has not responded adequately to methotrexate or who have been unable to tolerate treatment with methotrexate (a type of disease- modifying anti-rheumatic drug, known as a DMARD).
Etanercept or infliximab (infliximab only in combination with methotrexate) are recommended as treatment options for adults with active RA who have not responded well to treatment with at least two DMARDs, including methotrexate.
Consultant rheumatologists, or consultant paediatric rheumatologists in the case of JIA, should prescribe these drugs, in accordance with the guidelines set out by the British Society for Rheumatology (BSR) or British Paediatric Rheumatology Group (BPRG).
Two registries have been set up by BSR and BPRG to monitor the dosage, the effects and any side effects of these drugs. The NICE guidance recommends that doctors should send information to the appropriate registry on a regular basis to help researchers to find out about the long-term effectiveness and side effects of treatment with etanercept and infliximab.
Andrew Dillon, Chief Executive of NICE, said: "The Institute's guidance on the use of etanercept and infliximab is positive news for people with RA and JIA, offering them access to treatments that have previously been subject to postcode prescribing. Rheumatoid arthritis is a progressive, disabling condition. The targeted use of these medicines can help people with this condition by delaying disease progression."
Ends
Notes for editors
Juvenile idiopathic arthritis
1. Juvenile idiopathic arthritis (JIA) is a term that covers a group of diseases that are characterised by persistent joint swelling, pain and limitation of movement. At its worst, JIA can affect growth, the muscles in joints and the eyes, and can cause permanent disability. Many children and young people with JIA require replacement of joints damaged by JIA. JIA is a relatively rare disease: about 1 child in every 1000 has JIA, so about 10,000 children in the UK are affected.
2. JIA affects children's personal and social development. Children often miss school and normal childhood activities, and as adults they may have a poorer chance of getting a well-paid job, or may not be able to work at all. JIA can also have a considerable impact on a child's family - not only emotionally but also financially because parents may restrict or give up their work so that they can care for their child.
3. Drug treatment for JIA involves non-steroidal anti-inflammatory drugs (NSAIDs), corticosteroids, and disease-modifying anti-rheumatic drugs (DMARDs). The most common DMARD used is methotrexate, which is given orally or by injection. However, neither methotrexate nor any other DMARD is currently licensed for use in children in the UK.
4. Children whose condition has not responded to methotrexate may benefit from treatment with etanercept.
Rheumatoid arthritis
5. Rheumatoid arthritis (RA) is a chronic (long-term), progressive, destructive and disabling condition that impacts severely on a person's quality of life. RA affects all aspects of life from education and employment through to family and social life. It is estimated that 40 out of 100 people with RA stop working within 5 years of being diagnosed with the condition. RA affects up to 1 in 100 people, and it is estimated that over 420,000 people in England and Wales have RA.
6. RA is caused by the inflammation of tissue in the joints, which causes pain, swelling and stiffness and can destroy the joint. Approximately 15 out of 100 people with RA have a particularly severe form of the disease that causes constant pain and swelling, which results in severe disability and loss of the use of the joints.
7. Traditional drug therapy for RA relies on various combinations of non-steroidal anti-inflammatory drugs (NSAIDs), analgesics (pain-relieving drugs), corticosteroids and disease-modifying anti-rheumatic drugs (DMARDs). Evidence suggests that patients with RA should be treated with DMARDs soon after diagnosis. If treatment with DMARDs is delayed then it is likely that the patient's condition will get worse more quickly.
8. If treatment with DMARDs does not work, the only option available to doctors and patients is to try to relieve the symptoms of RA rather than delay the course of the disease. This means that people with RA who do not respond to DMARDS are not having their medical needs met, and it is this group that may benefit from treatment with etanercept or infliximab.
Etanercept and infliximab
9. Tumour necrosis factor alpha (TNFa) is a substance produced by the body. It is involved in the process of inflammation. In people who have RA, too much TNFa is produced by the body and causes inflammation that damages the cartilage and bone.
10. Etanercept works by preventing TNFa attaching itself to the tissue in the joint. It is licensed for the treatment of active JIA in children aged 4 to 17 years and active RA in adults. Etanercept is administered twice weekly by injection. 11. Etanercept can be given for an indefinite period, but doctors usually stop treatment with etanercept once a child with JIA has had 2 years without any symptoms of the disease. However, 3 out of 10 children have a relapse after the treatment has been stopped.
12. Infliximab works by attaching itself to TNFa and making it inactive. It is currently licensed for use only in combination with methotrexate:
when treatment with DMARDs, including methotrexate, has have not worked.
13. The cost of implementing both pieces of guidance in England and Wales is estimated to be between £58 million and £78 million per year (£3 million for JIA and between £55 million and £75 million for RA).
Information on NICE
14. Copies of the full guidance and supporting documentation will be available on the NICE web site (www.nice.org.uk) from midday on 22nd March 2002.
15. Health professionals are expected to take the Institute's guidance fully into account when exercising their clinical judgement for individual patients. This guidance does not, however, override the individual responsibility of health professionals to make appropriate decisions in the circumstances of the individual patient, in consultation with the patient and/or guardian or carer.
16. The National Institute for Clinical Excellence (NICE) is a part of the NHS. Part of its work is technology appraisals. The Institute produces guidance for both the NHS and patients on medicines, medical equipment and clinical procedures based on evidence of clinical and cost effectiveness. Each appraisal takes an average 12 months to complete and involves the manufacturers of the technology, groups that represent patients/carers and healthcare professionals.
17. The timeline for this appraisal was extended following consultation with consultees. The Appraisal Committee asked consultees to carry out additional work on the data they submitted. It was not possible to fully consider this evidence within the original schedule and the appraisal was therefore extended.
18. NICE promotes clinical and cost effectiveness through its technology appraisals, clinical guidelines and audit tools. The Institute supports the work of those who make the complex treatment decisions - doctors, nurses, and other health professionals. The needs of the patient are central to NICE's work, and the Institute has forged strong links with patient groups and representatives.
19. Topics for the NICE work programme are selected by the Department of Health and the National Assembly for Wales. NICE advises the NHS on how these technologies can best be used. It is also responsible for the production of national clinical guidelines, promoting best practice throughout the NHS. To support and assess the implementation of such guidelines, audit tools are produced for use in the clinical setting.
