rituximab 100mg/10ml, 500mg/50ml ml solution for intravenous infusion (MabThera)

Following a full submission.

Rituximab (MabThera) is accepted for restricted use within NHS Scotland in combination with methotrexate for treatment of adult patients with severe active rheumatoid arthritis who have had an inadequate response or intolerance to other disease-modifying anti-rheumatic drugs (DMARDs) including one or more tumour necrosis factor (TNF) inhibitor. It is restricted to use by Specialist physicians experienced in the diagnosis and treatment of rheumatoid arthritis.

Rituximab in combination with methotrexate improves signs and symptoms and quality of life and prevents joint damage compared to methotrexate, in adults with rheumatoid arthritis who have had an inadequate response to methotrexate and an inadequate response or intolerance to at least one TNF-antagonist. Treatment should only be repeated in patients who continue to achieve an American College of Rheumatology (ACR) response of at least 20.

Rituximab is cost effective if the average dosing interval for those patients who respond to initial treatment does not fall below six months.