NICE recommends sarilumab for rheumatoid arthritis
In a final appraisal determination, NICE has recommended the biological disease-modifying antirheumatic drug (DMARD) sarilumab (Kevzara) for routine NHS use in the treatment of certain patients with rheumatoid arthritis.
Sarilumab, in combination with methotrexate, is recommended as an option for the treatment of severe active rheumatoid arthritis in adults whose disease has responded inadequately to intensive therapy with a combination of conventional DMARDs. Severe disease is defined as a disease activity score (DAS28) of more than 5.1. Sarilumab is also recommended with methotrexate in adults with severe active disease who have responded inadequately to, or who cannot take, other DMARDs, including at least one biological DMARD, and who cannot take rituximab.
NICE adds that sarilumab can be used as monotherapy in patients who cannot take methotrexate because of a contraindication or intolerance. Treatment should be continued only if there is at least a moderate response, as measured using the European League Against Rheumatism (EULAR) criteria at six months after starting therapy, or if the response to therapy is not maintained.
Sarilumab was licensed in the UK in June 2017 for the treatment of moderately to severely active rheumatoid arthritis in adult patients who have responded inadequately to, or who are intolerant to, one or more DMARDs. It is a human monoclonal antibody against the IL-6 receptor, which works by blocking IL-6-mediated signalling. IL-6 is a cytokine that has been shown to contribute to both the pathological inflammation and joint destruction associated with rheumatoid arthritis.
The efficacy and safety of sarilumab has been assessed in three randomised controlled trials (MOBILITY, TARGET and MONARCH) in adults with moderately to severely active rheumatoid arthritis. In these studies, treatment with sarilumab was associated with a significantly greater proportion of patients achieving a 20% improvement in American College of Rheumatology response criteria (ACR20) compared with placebo or adalimumab.
The recommended dosage is 200mg every two weeks, administered as a subcutaneous injection. The dosage can be reduced to 150mg every two weeks in the case of neutropenia, thrombocytopenia or elevated liver enzymes. The list price is £457.69 per dose, but the company has agreed to a discount to the list price as a condition of the NICE recommendation.