Achieving Safe, Sustained Remission in Giant Cell Arteritis With Upadacitinib, with Frank Buttgereit, MD

Upadacitinib 15 mg has continued to demonstrate its tolerable safety profile and clinical benefit over placebo or people with giant cell arteritis (GCA) along with a shorter glucocorticoid (GC) tapering and low rates of serious infection.1

The therapy was approved in April 2025 for the treatment of adults with GCA under the name Rinvoq.2

Updated data from the pivotal SELECT-GCA trial, were presented by Frank Buttgereit, MD, Professor of Rheumatology and Deputy Head of the Department of Rheumatology and Clinical Immunology, Department of Rheumatology and Clinical Immunology, Charité-Universitätsmedizin Berlin, at the European Alliance of Associations for Rheumatology (EULAR) Congress 2025 in Barcelona, Spain, taking place June 11-14, 2025.

Among the new data were low rates of serious infections through week 52 with both upadacitinib 15 mg (7.9 events/100 patient-years [E/100 PY]; 95% CI, 4.3–13.2) and 7.5 mg (7.9 E/100 PY; 95% CI, 3.2–16.3) compared to placebo (12.7 E/100 PY; 95% CI, 6.6–22.2). In contrast, herpes zoster rates were higher with upadacitinib 15 mg (7.3 E/100 PY; 95% CI, 3.9–12.5) but comparable between upadacitinib 7.5 mg (4.5 E/100 PY; 95% CI, 1.2–11.6) and placebo (4.2 E/100 PY; 95% CI, 1.2–10.9).1

Overall, there were low rates of opportunistic infections across all groups, with no cases were reported with the 7.5 mg dose, and 4 were seen with 15 mg, including 1 serious case of Pneumocystis jiroveci pneumonia that led to treatment discontinuation. The others cases did not result in discontinuation and were mild to moderate.1

After post-glucocorticoid (GC) tapering, serious infection rates remained lower with upadacitinib 7.5 mg (3.4 E/100 PY; 95% CI, 0.7–9.9) and 15 mg (3.9 E/100 PY; 95% CI, 1.6–8.1) compared to placebo (8.5 E/100 PY; 95% CI, 3.7–16.7), while rates of Herpes zoster rates were similar between upadacitinib 15 mg and placebo during and after the GC taper. Baseline GC dose did not appear to influence serious infection risk.1

HCPLive spoke with Buttgereit to learn more about notable findings from the SELECT-GCA trial, including safety and efficacy.

"All in all, this study was able to demonstrate that upadacitinib 15 mg, combined with the short term glucocorticoid tapering, is able to demonstrate superior efficacy and to reduce the cumulative glucocorticoid dose and generally in this population was safe [as it is in] other indications, such as rheumatoid arthritis," Buttgereit said.

REFERENCES

1. Buttgereit F, Winthrop KL, Calabrese LH, et al. Impact of Glucocorticoid Tapering in Giant Cell Arteritis: Analysis From the SELECT-GCA Trial. Presented at: EULAR Congress 2025; Barcelona, Spain; June 11-14. Presentation #OP0057

2. RINVOQ® (upadacitinib) Receives U.S. FDA Approval for Giant Cell Arteritis (GCA). News release. AbbVie. April 29, 2025. https://news.abbvie.com/2025-04-29-RINVOQ-R-upadacitinib-Receives-U-S-FDA-Approval-for-Giant-Cell-Arteritis-GCA