FDA Approvals, Highlights, and Summaries: Rheumatology

February 27, 2020

Rinvoq (upadacitinib)

Upadacitinib, a Janus kinase-1 (JAK1) selective inhibitor, is indicated for moderately to severely active rheumatoid arthritis (RA) in adults who have had an inadequate response to or are intolerant of methotrexate. It may be used as monotherapy or in combination with methotrexate or other nonbiological disease-modifying antirheumatic drugs.

JAK1 is essential for certain cytokines to elicit signals from various interleukins, cardiotrophin, neurotrophin, and interferons. These signals are crucial in maintaining the inflammatory condition in RA. Inhibition of JAK reduces production of and modulates proinflammatory cytokines central to RA.

Approval was based on data from the SELECT phase 3 RA program that enrolled over 4000 patients with moderate to severe RA across 5 studies. In the SELECT-MONOTHERAPY study, 598 of 648 patients completed the study. At week 14, an American College of Rheumatology 20% (ACR20) response was achieved by 89 (41%) of 216 patients in the continued-methotrexate group, 147 (68%) of 217 patients receiving upadacitinib 15 mg, and 153 (71%) of 215 patients receiving upadacitinib 30 mg (P<.0001 for both doses vs continued methotrexate).

Lancet. 2019 Jun 8;393(10188):2303-2311

The SELECT-COMPARE study evaluated safety and effectiveness of upadacitinib compared with adalimumab (each with methotrexate) over 48 weeks. Results showed low disease activity, clinical remission, and improvements in pain and function remained superior for upadacitinib compared with adalimumab at 26 weeks and from weeks 26-48.

Ann Rheum Dis. 2019 Jul 30

Additional 2019 Rheumatology approvals

Taltz (ixekizumab) gained approval for active ankylosing spondylitis.

Cimzia (certolizumab pegol) gained approval for active nonradiographic axial spondyloarthritis with objective signs of inflammation.


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