Adding Upadacitinib to the Treatment Landscape of GCA, with Daniel Blockmans, MD, PhD

The FDA last month approved Upadacitinib 15 mg once daily for the treatment of adults with giant cell arteritis (GCA), under the name Rinvoq, making the therapy the second disease modifying therapy approved for GCA after tocilizumab’s approval in 2017.1,2

Upadacitinib’s approval was based off of data from the phase 3 SELECT-GCA clinical trial in which 46.4% (95% CI, 39.6-53.2) of patients receiving upadacitinib 15 mg in combination with a 26-week steroid taper regimen achieving sustained remission from week 12 to week 52, compared with 29.0% (95% CI, 20.6-37.5) of patients receiving placebo in combination with a 52-week steroid taper regimen (P = .002).3

HCPLive spoke with Daniel Blockmans, MD, PhD, Department of General Internal Medicine, University Hospitals Leuven, Belgium, who served as a primary investigator on the SELECT-GCA trial, to learn more about the data supporting upadacitinib’s approval and how the new approval is important for adding to the treatment landscape. He discussed the unmet need for new treatments that exists within the population of patients with GCA and the importance of being able to successfully taper steroids in patients who might be sensitive to them or typically relapse without them.

“Steroids are great. I'm very grateful that we have them. But of course, they come with side effects, and some people are much more vulnerable to these than others, and for these vulnerable patients, we need something else than steroids,” Blockmans told HCPLive.

Blockmans reported no relevant disclosures.

REFERENCES

1. 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

2. FDA approves first drug to specifically treat giant cell arteritis. News release. FDA. May 22, 2017. https://www.fda.gov/news-events/press-announcements/fda-approves-first-drug-specifically-treat-giant-cell-arteritis

3. Blockmans D, Penn SK, Setty AR, et al. A Phase 3 Trial of Upadacitinib for Giant-Cell Arteritis. New Eng J Med. Published online April 2, 2025. DOI: 10.1056/NEJMoa2413449