NICE guidance - tocilizumab for the treatment of rheumatoid arthritis

Rituximab is a genetically engineered chimeric monoclonal antibody that depletes the B-cell population by targeting cells bearing the CD20 surface marker

• rituximab in combination with methotrexate is licensed for the treatment of adults with severe active rheumatoid arthritis who have had an inadequate response to or intolerance of other DMARDs, including one or more tumour necrosis factor a (TNF-a) inhibitor therapies

Summary features of the NICE guidance relating to the use of rituximab is outlined below:

• 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 intolerance of other disease-modifying anti-rheumatic drugs (DMARDs), including treatment with at least one tumour necrosis factor a (TNF-a) inhibitor therapy
• treatment with rituximab plus methotrexate should be continued only if there is an adequate response following initiation of therapy. An adequate response is defined as an improvement in disease activity score (DAS28) of 1.2 points or more. Repeat courses of treatment with rituximab plus methotrexate should be given no more frequently than every 6 months
• treatment with rituximab plus methotrexate should be initiated, supervised and treatment response assessed by specialist physicians experienced in the diagnosis and treatment of rheumatoid arthritis

Tocilizumab, in combination with methotrexate is recommended as an option for the treatment of rheumatoid arthritis in adults if:

• the disease has responded inadequately to disease-modifying anti-rheumatic drugs (DMARDs) and it is used as described for tumour necrosis factor (TNF) inhibitor treatments in Adalimumab, etanercept and infliximab for the treatment of rheumatoid arthritis, specifically the recommendations on disease activity and choice of treatment or
• the disease has responded inadequately to DMARDs and a TNF inhibitor and the person cannot receive rituximab because of a contraindication to rituximab, or because rituximab is withdrawn because of an adverse event, and tocilizumab is used as described for TNF inhibitor treatments in Adalimumab, etanercept, infliximab, rituximab and abatacept for the treatment of rheumatoid arthritis after the failure of a TNF inhibitor, specifically the recommendations on disease activity or
• the disease has responded inadequately to one or more TNF inhibitor treatments and to rituximab

Also:

• 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
• 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
• treatment with adalimumab, etanercept, infliximab and abatacept should be continued only if there is an adequate response (as defined in 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
• 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
• 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

Reference:

1. NICE (August 2010).Adalimumab, etanercept, infliximab, rituximab and abatacept for the treatment of rheumatoid arthritis after the failure of a TNF inhibitor
2. NICE (February 2012).Tocilizumab for the treatment of rheumatoid arthritis