Adalimumab, Etanercept, Infliximab, Rituximab and Abatacept for the Treatment of Rheumatoid Arthritis after the Failure of a TNF Inhibitor (TA195)

Technology Appraisal Guidance No. 195

Source: National Institute for Health and Care Excellence

NOTE: This guidance 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.

The appraisal of adalimumab and the review of the appraisals of etanercept, infliximab, rituximab and abatacept for the treatment of rheumatoid arthritis have resulted in changes in the guidance. Rituximab in combination with methotrexate is still recommended as an option for the treatment of adults with severe active rheumatoid arthritis who have had an inadequate response to, or have an intolerance of, other DMARDs, including at least one TNF inhibitor. Additional treatment options are now recommended for these adults if rituximab therapy is contraindicated or withdrawn because of an adverse event, specifically:

  • If rituximab is contraindicated or withdrawn, adalimumab, etanercept, infliximab and abatacept, each in combination with methotrexate, are now recommended as treatment options.
  • If rituximab therapy cannot be given because methotrexate is contraindicated or withdrawn because of an adverse event, adalimumab and etanercept, each as monotherapy, are now recommended as treatment options

1. Guidance

1.1 Rituximab in combination with methotrexate is recommended as an option for the treatment of adults with severe active rheumatoid arthritis who have had an inadequate response to, or are intolerant of, other disease-modifying anti-rheumatic drugs (DMARDs), including at least one tumour necrosis factor (TNF) inhibitor. Treatment with rituximab should be given no more frequently than every 6 months.

1.2 Treatment with rituximab in combination with methotrexate should be continued only if there is an adequate response following initiation of therapy and if an adequate response is maintained following retreatment with a dosing interval of at least 6 months. An adequate response is defined as an improvement in disease activity score (DAS28) of 1.2 points or more.

1.3 Adalimumab, etanercept, infliximab and abatacept, each in combination with methotrexate, are recommended as treatment options only for adults with severe active rheumatoid arthritis who have had an inadequate response to, or have an intolerance of, other DMARDs, including at least one TNF inhibitor, and who cannot receive rituximab therapy because they have a contraindication to rituximab, or when rituximab is withdrawn because of an adverse event.

1.4 Adalimumab monotherapy and etanercept monotherapy are recommended as treatment options for adults with severe active rheumatoid arthritis who have had an inadequate response to, or have an intolerance of, other DMARDs, including at least one TNF inhibitor, and who cannot receive rituximab therapy because they have a contraindication to methotrexate, or when methotrexate is withdrawn because of an adverse event.

1.5 Treatment with adalimumab, etanercept, infliximab and abatacept should be continued only if there is an adequate response (as defined in 1.2) 6 months after initiation of therapy. Treatment should be monitored, with assessment of DAS28, at least every 6 months and continued only if an adequate response is maintained.

1.6 When using DAS28, healthcare professionals should take into account any physical, sensory or learning disabilities, communication difficulties, or disease characteristics that could adversely affect patient assessment and make any adjustments they consider appropriate.

1.7 A team experienced in the diagnosis and treatment of rheumatoid arthritis and working under the supervision of a rheumatologist should initiate, supervise and assess response to treatment with rituximab, adalimumab, etanercept, infliximab or abatacept.


The guidance shown above constitutes Section 1 of the full document. A copy of the full document and a summary of the evidence is available on the Internet at http://guidance.nice.org.uk/TA195

An abridged version of this guidance (a 'quick reference guide') is also available. Printed copies of the quick reference guide can be obtained by contacting 0845 003 7783 or emailing publications@nice.org.uk and quoting reference number N2245. It is also available on the Internet at http://guidance.nice.org.uk/TA195/QuickRefGuide/pdf/English

This guidance represents the view of the Institute which was arrived at after careful consideration of the available evidence. Health professionals are expected to fully take it into account when exercising their clinical judgement. 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.

© Copyright National Institute for Health and Care Excellence. All rights reserved. This material may be freely reproduced for educational and not for profit purposes within the NHS. No reproduction by or for commercial organisations is permitted without the express written permission of the Institute.

Enquiries concerning the guidance should be addressed to: National Institute for Health and Care Excellence, MidCity Place, 71 High Holborn, London WC1V 6NA. email: nice@nice.org.uk

Adalimumab, Etanercept, Infliximab, Rituximab and Abatacept for the Treatment of Rheumatoid Arthritis after the Failure of a TNF Inhibitor.
Issue Date: August 2010
Review Date: June 2013


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