A Phase 3 Trial of Upadacitinib for Giant-Cell Arteritis

Giant-cell arteritis is a systemic vasculitis with limited treatment options. The efficacy and safety of upadacitinib - a selective Janus kinase (JAK) inhibitor that blocks the signaling of several cytokines, including interleukin-6 and interferon-γ - are unknown in patients with giant-cell arteritis.

We randomly assigned patients with new-onset or relapsing giant-cell arteritis, in a 2:1:1 ratio, to receive upadacitinib at a dose of 15 mg or 7.5 mg orally once daily plus a 26-week glucocorticoid taper or placebo plus a 52-week glucocorticoid taper. The primary end point was sustained remission at week 52, defined by the absence of signs or symptoms of giant-cell arteritis from week 12 through week 52 and adherence to the protocol-specified glucocorticoid taper.