Abstract

Upadacitinib (Rinvoq™), an oral Janus kinase (JAK) 1 inhibitor, is approved as monotherapy or in combination with nonbiological disease-modifying antirheumatic drugs (DMARDs), including methotrexate, in adult patients with moderate to severely active rheumatoid arthritis (RA) who have responded inadequately to, or who are intolerant to one or more DMARD. Across phase 3 trials in patients with RA, once-daily upadacitinib treatment was generally well tolerated and associated with rapid and clinically relevant disease remission or low disease activity when administered as monotherapy or in combination conventional synthetic DMARDs (csDMARDs), including in patients who were intolerant to or had an inadequate response to prior csDMARDs or biological DMARD (bDMARD) therapy. In addition, in head-to-head trials, upadacitinib was more effective than both adalimumab in patients with an inadequate response to methotrexate and abatacept in patients with an inadequate response to or intolerance to bDMARDs. The clinical benefits of upadacitinib, including slowing progression of joint damage, were maintained over the longer term and no new safety signals were identified.

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