Clinical outcomes of upadacitinib continuation vs withdrawal in giant cell arteritis through 2 years.

In the SELECT-GCA trial, upadacitinib 15 mg/d was associated with higher rates of disease remission and reduced glucocorticoid exposure vs placebo in patients with giant cell arteritis (GCA) through 1 year. This study evaluated the clinical impact of upadacitinib continuation vs withdrawal through 2 years. In period 1 of SELECT-GCA, patients aged ≥50 years were randomised 2:1:1 to oral upadacitinib 15 mg or 7.5 mg with a 26-week glucocorticoid taper or placebo with a 52-week taper. In period 2 (52-week re-randomised, blinded extension), patients achieving ≥24 weeks of consecutive remission by week 52 were re-randomised 2:1 to continue upadacitinib or switch to placebo. Efficacy endpoints were assessed from weeks 52 to 104, and safety was evaluated over 2 years. All P values are nominal. Among 103 patients receiving upadacitinib 15 mg who achieved ≥24 weeks sustained remission and were re-randomised in period 2, 68 continued treatment and 35 switched to placebo at week 52. From weeks 52 to 104, patients continuing upadacitinib 15 mg vs switching to placebo experienced fewer disease flares (7.4% vs 59.5%; P ≤ .0001), greater maintenance of glucocorticoid-free remission (71.7% vs 31.4%; P ≤ .0001), and lower glucocorticoid exposure (median exposure: 0 mg vs 1048 mg; P ≤ .0001). Safety was generally similar between upadacitinib and placebo groups. No new clinically significant safety risks were identified with upadacitinib through 2 years, and safety remained consistent with the established profile. These data further support a favourable benefit-risk profile for extended use of upadacitinib 15 mg for treatment of GCA.