People with rheumatoid arthritis will benefit from two new pieces of NICE guidance published today (25 August 2010). NICE recommends rituximab, adalimumab, etanercept, infliximab and abatacept, in certain circumstances, as possible treatments for rheumatoid arthritis after treatment with a tumour necrosis factor (TNF) inhibitor has failed. In separate guidance, NICE also recommends tocilizumab, under certain circumstances, as an additional option for treatment of rheumatoid arthritis.

The guidance on treatment with rituximab, adalimumab, etanercept, infliximab and abatacept, issued to the NHS today, recommends:

• Rituximab (MabThera) in combination with methotrexate, is recommended as an option for the treatment of adults with severe active rheumatoid arthritis that has responded inadequately to other disease-modifying anti-rheumatic drugs (DMARDs), including treatment with at least one TNF inhibitor, or who are intolerant of other DMARDs. Treatment with rituximab should not be given more frequently than every six months and should only be continued if there is an adequate response[1].
• Adalimumab (Humira), etanercept (Enbrel), infliximab (Remicade) and abatacept (Orencia), each in combination with methotrexate are recommended for the treatment of people with severe active rheumatoid arthritis that has responded inadequately to other DMARDs, including treatment with at least one TNF inhibitor, or who are intolerant of other DMARDs and where people cannot take rituximab because rituximab is contraindicated, or when rituximab is withdrawn because of an adverse event. Treatment with adalimumab, etanercept, infliximab and abatacept should be continued only if there is an adequate response1 six months after the start of therapy.
• Adalimumab monotherapy (where the drug is given without methotrexate) and etanercept monotherapy are recommended in the circumstances outlined above but where people cannot take rituximab because methotrexate is contraindicated, or methotrexate is withdrawn because of an adverse event.

The guidance on tocilizumab recommends:

• Tocilizumab (RoActemra), in combination with methotrexate, is recommended for the treatment of rheumatoid arthritis in people whose rheumatoid arthritis has responded inadequately to one or more TNF inhibitors and:
• whose rheumatoid arthritis has responded inadequately to rituximab

or

• in whom rituximab is contraindicated or when rituximab is withdrawn because of an adverse effect.

Dr Carole Longson, Director of the Health Technology Evaluation Centre at NICE, said: "We are pleased to issue two new pieces of final guidance to the NHS which will benefit people with rheumatoid arthritis. Around 87,000 people in England and Wales have severe rheumatoid arthritis, which can have a major impact on quality of life.

"We have already recommended the TNF inhibitors adalimumab, etanercept and infliximab for some people with rheumatoid arthritis as options for use after treatment with conventional drugs. In the first new piece of guidance we recommend treatment options when a TNF inhibitor has not worked or when it has lost its effect. The evidence suggests that rituximab works in this context and is a cost-effective treatment option.

"As not all patients are able to take rituximab, the guidance recommends that adalimumab, etanercept, infliximab or abatacept, each in combination with methotrexate, may be given. For patients who cannot take rituximab because methotrexate is contraindicated or has been withdrawn, then adalimumab or etanercept given as monotherapy is recommended. This guidance updates and replaces previous NICE guidance on treatments received at this point in the pathway of care.

"In the second new piece of guidance, NICE recommends tocilizumab as an option for people with rheumatoid arthritis if there has been an inadequate response to one or more TNF inhibitors and where rituximab has also produced an inadequate response or where it is contraindicated or has produced undesirable side effects. Recommending tocilizumab means that another treatment option is now available for people with rheumatoid arthritis.

"We hope that this wider choice of options will mean that people will be able to manage their rheumatoid arthritis more effectively."

Ends

Notes to Editors

About the guidance

1. The guidance is available to view from 25 August 2010 (Rheumatoid arthritis - drugs for treatment after failure of a TNF inhibitor and Rheumatoid arthritis - tocilizumab).

2. The drugs recommended in the two pieces of NICE guidance are:

• rituximab (MabThera, Roche Products)
• adalimumab (Humira, Abbott Laboratories)
• etanercept (Enbrel, Wyeth Pharmaceuticals)
• infliximab (Remicade, Schering-Plough part of Merck, Sharp and Dohme)
• abatacept (Orencia, Bristol-Myers Squibb)
• tocilizumab (RoActemra, Roche Products).

3. It is estimated that 580,000 people in England and Wales have rheumatoid arthritis.

4. DAS28 is a disease activity scoring system developed in Europe. It is calculated using a formula that includes counts for 28 tender and swollen joints, an evaluation of general health by the patient (on a scale of 0 to 100) and a measure of circulating inflammatory markers. A DAS28 score greater than 5.1 indicates high disease activity, between 3.2 and 5.1 moderate disease activity, and less than 3.2 low disease activity. A score of less than 2.6 indicates disease remission. An improvement in DAS28 score of 0.6 or less is considered a poor response, and improvements greater than 1.2 points indicate a good response.

5. Technology appraisal guidance 195 replaces NICE technology appraisal guidance 126 and 141 issued in August 2007 and April 2008 respectively. It also replaces the remaining recommendations in NICE technology appraisal guidance 36 issued in March 2002.

6. NICE has previously recommended adalimumab, etanercept and infliximab as possible treatments for people with rheumatoid arthritis after the failure of conventional DMARDs (technology appraisal 130).

7. The annual acquisition costs of the technologies appraised are:

• rituximab - £3,492 for one course to £6,984 for two courses per year
• adalimumab - £9,295
• etanercept - £9,295
• infliximab - £10,072 in the first year, £7,553 - £8,812 in subsequent years (annual cost will vary depending on patient's weight)
• abatacept - £10,171 in the first year, £9,444 in subsequent years (annual cost will vary depending on patient's weight)
• tocilizumab - £9295 per year for a patient weighing approximately 70 kg.

Costs may vary in different settings because of negotiated procurement discounts.

About NICE

1. The National Institute for Health and Care 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, procedures and health technologies within the NHS
• clinical practice - guidance on the appropriate treatment and care of people with specific diseases and conditions within the NHS.