Arthritis Rheumatol

ACR 2025: JAK inhibitor achieves sustained remission in giant cell arteritis

October 31, 2025

For patients with giant cell arteritis (GCA) who achieved remission on upadacitinib (UPA), continuing therapy rather than switching to placebo maintained disease control and reduced steroid burden without new major safety concerns over two years. These findings were shared at the ACR Convergence.

Study details: The phase 3 SELECT-GCA trial included a 52-week randomized, placebo-controlled period (period one) and a 52-week randomized, blinded extension period (period two). Patients ≥50 years with active GCA were randomized to UPA 15 mg, 7.5 mg, or placebo with protocol-defined glucocorticoid tapers. After one year, patients in remission for ≥24 weeks were re-randomized to continue UPA or switch to placebo. Outcomes: remission maintenance, flare risk, cumulative glucocorticoid exposure, and safety through week 104.

Results: Of 428 patients in period one, 181 (42%) achieved sustained remission and entered period two. Most (91%) completed the study, with 82% remaining on study drug. From week 52 to 104, 68.6% of patients on continuous UPA 15 mg maintained remission vs. 28.6% who switched to placebo, representing a 90% reduction in flare risk. Continuous UPA 15 mg also reduced cumulative glucocorticoid use by ~1 g and improved flare-related endpoints. Safety was similar across groups; serious treatment-emergent adverse events were lower with UPA, though herpes zoster and creatine kinase elevations were more frequent. One case of venous thromboembolism occurred in the UPA 15 mg group (with multiple risk factors); no MACE or deaths were reported.

Source:

Schmidt W, et al. “Efficacy and Safety of Upadacitinib in Giant Cell Arteritis: 2-Year Results From the Re-Randomized, Double-Blind SELECT-GCA Phase 3 Trial” [abstract]. Arthritis Rheumatol. https://acrabstracts.org/abstract/efficacy-and-safety-of-upadacitinib-in-giant-cell-arteritis-2-year-results-from-the-re-randomized-double-blind-select-gca-phase-3-trial/. Accessed October 30, 2025.