NICE recommends tofacitinib for severe rheumatoid arthritis

NICE has now published final guidance (TA480) recommending the use of tofacitinib (Xeljanz) for the treatment of severe active rheumatoid arthritis.

Tofacitinib, together with methotrexate, is recommended for the treatment of active rheumatoid arthritis in adults whose disease has responded inadequately to intensive therapy with a combination of conventional disease-modifying antirheumatic drugs (DMARDs), only if disease is severe (defined as a disease activity score of more than 5.1). It is also recommended in combination with methotrexate in adults with severe disease who have responded inadequately, to or cannot take, other DMARDs including at least one biological DMARD and who also cannot take rituximab. Tofacitinib can also be used as monotherapy in patients who cannot take methotrexate. Treatment should be continued only if there is a moderate response using the European League Against Rheumatism (EULAR) criteria at six months after starting therapy, and if this response is maintained.

Tofacitinib is an oral janus kinase (JAK) inhibitor that preferentially inhibits JAK1 and JAK3. It is the second JAK inhibitor to gain NICE approval for severe active rheumatoid arthritis, the first being baricitinib (Olumiant) in August this year. JAK inhibitors are a new class of DMARD that attenuate intracellular messaging of several different cytokines (interleukins and interferons) involved in inflammatory responses.

Tofacitinib was licensed in the EU in March 2017 for the treatment of moderate to severe active rheumatoid arthritis in adults who have responded inadequately to, or who are intolerant to, one or more DMARDs, in combination with methotrexate (or as monotherapy when methotrexate is inappropriate). The recommended dosage is 5mg twice daily, which should be reduced to 5mg once daily in patients with severe renal impairment or moderate hepatic impairment; it is contraindicated in patients with severe hepatic impairment.

In the ORAL series of clinical trials, tofacitinib significantly improved signs and symptoms of rheumatoid arthritis (as measured by American College of Rheumatology criteria (ACR20) response rates) and reduced disability compared with placebo. The most common adverse effects include infections, gastrointestinal disorders, leukopenia and anaemia, dyslipidaemia, hypertension, insomnia and headache. Tofacitinib should not be initiated in patients with serious infections, and treatment should be interrupted if a serious infection develops.

The cost of tofacitinib is approximately £690 per month; however, the company has agreed a discount to the list price in a patient access scheme, which is another condition of the NICE recommendation.

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