PRESS RELEASE: NICE Appraisal of Rituximab and Adalimumab for the Treatment of Arthritis

NICE Appraisal of Rituximab and Adalimumab for the Treatment of Arthritis

LONDON, Aug. 22, 2007-The National Institute for Health and Clinical Excellence (NICE) has today (22 August) published final guidance on the use of rituximab (Mabthera) for the treatment of rheumatoid arthritis and adalimumab (Humira) for the treatment of psoriatic arthritis, as part of its rapid single technology appraisal (STA) work programme.

NICE recommends:

• Rituximab in combination with methotrexate is recommended as a treatment option for adults with severe active rheumatoid arthritis who have had an inadequate response to or intolerance of other disease modifying anti-rheumatic drugs. This should include treatment with at least one tumour necrosis factor (TNF) inhibitor therapy

• Treatment with rituximab plus methotrexate should be continued only if there is an adequate response following initiation of therapy

• Adalimumab is recommended as a treatment option for adults with active and progressive psoriatic arthritis when the person has peripheral arthritis with three or more tender joints and three or more swollen joints, and the psoriatic arthritis has not responded to adequate trials of at least two standard disease-modifying anti-rheumatic drugs

• Adalimumab treatment should be discontinued after 12 weeks in adults whose psoriatic arthritis has not shown an adequate response.

Andrew Dillon, Executive Lead for the appraisal said: "Following further clarification from the manufacturer on the economic analysis of rituximab, the committee has assessed that these drugs represent the right approach for the NHS to take in the treatment of two severe forms of arthritis. It is estimated that up to 1%

of the population suffers from rheumatoid or psoriatic arthritis, which are both very distressing, causing a great deal of pain or discomfort and impacting on an individual’s ability to go about their daily life. The approval of both of these drugs is good news for anyone suffering from rheumatoid or psoriatic arthritis - by recommending the use of these drugs, people in England and Wales with these conditions can be reassured that they have access to effective treatments when they need them."

Ends

Notes to Editors

About NICE

1. The National Institute for Health and Clinical Excellence (NICE) is the independent organisation responsible for providing national guidance on the promotion of good health and the prevention and treatment of ill health.

2. NICE produces guidance in three areas of health:

• public health – guidance on the promotion of good health and the prevention of ill health for those working in the NHS, local authorities and the wider public and voluntary sector

• health technologies – guidance on the use of new and existing medicines, treatments and procedures within the NHS

• clinical practice – guidance on the appropriate treatment and care of people with specific diseases and conditions within the NHS.

About the guidance

3. The adalimumab and rituximab guidance is available at www.nice.org.uk/TA125 [1] and www.nice.org.uk/TA126 [2].

4. Rheumatoid arthritis (RA) is a chronic, disabling condition characterised by inflammation of the synovial tissue of the joints, causing pain, swelling and stiffness and progressive joint destruction. It affects between 0.5% and 1% of the population, or approximately 400,000 people in England and Wales. Of these, approximately 15% have severe disease. RA affects three times as many women as men and has a peak age of onset of 40-70 years.

5. Psoriatic arthritis (psoriatic arthropathy) is an inflammatory joint disease closely associated with the skin disease psoriasis. An estimated 5–7% of all people with psoriasis have psoriatic arthritis, but it is much more common in those with extensive psoriasis. Psoriatic arthritis has an overall prevalence of between 0.1% and 1%. It affects men and women equally and its incidence peaks between the ages of 30 and 55 years.