JAK Inhibitor Upadacitinib Achieves Superior Sustained Remission in Giant Cell Arteritis Phase 3 Trial
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A large phase 3 clinical trial found that upadacitinib, an oral JAK inhibitor, helped significantly more patients with giant cell arteritis achieve sustained remission compared to standard steroid treatment alone. Patients taking 15 mg of upadacitinib daily had nearly double the remission rate at one year and were able to taper off steroids faster. These findings led to FDA approval of upadacitinib for giant cell arteritis, offering patients a new oral treatment option beyond existing biologic therapies.
Abstract
Giant cell arteritis (GCA) is a large-vessel vasculitis primarily affecting adults over 50, for which glucocorticoids have remained the cornerstone of treatment for decades despite significant long-term side effects. Upadacitinib is a selective Janus kinase (JAK) inhibitor that blocks cytokine signaling pathways implicated in GCA pathogenesis, including interleukin-6 and interferon-gamma.
In the SELECT-GCA phase 3 trial, 428 patients with new-onset or relapsing GCA were randomized 2:1:1 to receive upadacitinib 15 mg, upadacitinib 7.5 mg, or placebo, each combined with a glucocorticoid taper of 26 or 52 weeks. The primary endpoint was sustained remission at week 52, defined by absence of flare and adherence to the glucocorticoid taper.
Sustained remission was achieved by 46.4% of patients in the upadacitinib 15 mg group versus 29.0% in the placebo group (P=0.002). The upadacitinib 7.5 mg dose did not demonstrate superiority over placebo. Serious adverse events were comparable between treatment groups, and the safety profile was consistent with that observed in other JAK inhibitor trials. These results support upadacitinib 15 mg as a new therapeutic option enabling shorter glucocorticoid exposure in GCA.