EMA recommends upadacitinib for rheumatoid arthritis

The EMA’s Committee for Medicinal Products for Human Use (CHMP) has recommended a marketing authorisation for upadacitinib (Rinvoq) for the treatment of rheumatoid arthritis.

Upadacitinib is a selective, reversible janus kinase (JAK) inhibitor that reduces the symptoms of rheumatoid arthritis by preferentially inhibiting JAK1 signalling, resulting in inhibition of interleukin-6 (IL-6) and interferon (IFN)-gamma mediated inflammatory responses.

The recommended full indication is for the treatment of moderate to severe active rheumatoid arthritis in adult patients who have responded inadequately to, or who are intolerant to, one or more disease-modifying antirheumatic drugs (DMARDs). The drug can be used as either monotherapy or in combination with methotrexate. It will be available as 15mg prolonged-release tablets to be administered orally once daily.

In the SELECT programme of phase 3 clinical trials, which included over 4000 patients with moderate to severe rheumatoid arthritis, upadacitinib, either alone or in combination with another DMARD, was associated with significantly greater improvement in symptoms (as measured using American College of Rheumatology [ACR] score) than placebo or methotrexate. The most frequent adverse effects were upper respiratory tract infections, nausea, increased blood creatine phosphokinase and cough, and the most common serious adverse reactions were severe infections.

NICE technology appraisal guidance is planned for upadacitinib in the treatment of moderate to severe rheumatoid arthritis (ID1400), with publication expected by March 2020.

Upadacitinib is also currently being investigated in phase 3 trials for the treatment of psoriatic arthritis, Crohn’s disease, atopic dermatitis, ulcerative colitis and giant cell arteritis.


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