Upadacitinib 15 mg once-daily has been granted approval by the European Commission (EC) for the treatment of giant cell arteritis (GCA) in adults, making it the first and only oral janus kinase (JAK) inhibitor approved for this use in the European Union (EU).1 This approval is backed by the results from the phase III SELECT-GCA trial (ClinicalTrials.gov identifier: NCT03725202), which was a multicenter, randomized, double-blind placebo-controlled study that evaluated the efficacy and safety of upadacitinib in 428 patients with GCA.2,3 This milestone marks the eighth indication for upadacitinib in the EU and offers a new treatment option for clinicians managing GCA.1
GCA is an autoimmune disease that causes inflammation of the arteries; complications can include headaches, tiredness, double vision and, occasionally, vision loss.4 GCA primarily affects older adults, typically those over the age of 50, and is also more common in women than men.4 There is no cure for GCA and the only first-line treatment option available is steroid tablets, which are used to control symptoms and prevent complications.4 The new approval offers a much-needed alternative option for patients with GCA.
In the SELECT-GCA trial, upadacitinib 15 mg, in combination with a 26-week steroid taper regimen, achieved primary and key secondary endpoints compared with placebo in combination with a 52-week steroid taper regimen.2,3 The study found that in the upadacitinib group, 46.4% of patients achieved the primary endpoint of sustained remission compared with 29% in the placebo group (p=0.002). Regarding secondary endpoints: (1) in the upadacitinib group, 34.3% of patients experienced at least one disease flare through week 52 compared with 55.6% in the placebo group (p=0.001); (2) through 52 weeks, cumulative steroid exposure was lower in the upadacitinib group (median exposure of 1,615 mg) compared with the placebo group (median exposure of 2,882 mg; p<0.001); (3) finally, 37.1% of patients in the upadacitinib group achieved sustained complete remission compared with 16.1% of patients in the placebo group (p<0.001). Throughout the 52-week trial, the safety profile was consistent between the upadacitinib and placebo groups.2,3
On the trial results, SELECT-GCA trial investigator, Prof. Wolfgang Schmidt (Waldfriede Hospital, Berlin, Germany) said:
“Results from the SELECT-GCA trial show that patients can achieve sustained remission and reduce their cumulative steroid exposure with RINVOQ [upadacitinb], addressing important patient goals in the treatment of GCA.”1
References
- PR Newswire. AbbVie Announces European Commission Approval of RINVOQ® (upadacitinib) for the Treatment of Adults with Giant Cell Arteritis. [Press release] 2025. Available at: www.prnewswire.com/news-releases/abbvie-announces-european-commission-approval-of-rinvoq-upadacitinib-for-the-treatment-of-adults-with-giant-cell-arteritis-302422669.html (accessed 9 April 2025).
- Blockmans D, Penn SK, Setty AR, et al. A phase 3 trial of upadacitinib for giant-cell arteritis. N Engl J Med. 2025. DOI: 10.1056/NEJMoa2413449.
- ClinicalTrials.gov. A study to evaluate the safety and efficacy of upadacitinib in participants with giant cell arteritis (SELECT-GCA). ClinicalTrials.gov identifier: NCT03725202. Available at: https://clinicaltrials.gov/ct2/show/NCT03725202 (accessed 9 January 2025).
- Versus Arthritis. What is giant cell arteritis (GCA)? 2025. Available at: https://versusarthritis.org/about-arthritis/conditions/giant-cell-arteritis-gca/ (accessed January 9, 2025).
Further content in vasculitis.
Editor: Victoria Jones, Senior Content Editor.
Disclosures: This article was created by the touchIMMUNOLOGY team utilizing AI as an editorial tool (ChatGPT (GPT-4o) [Large language model]. https://chat.openai.com/chat.) The content was developed and edited by human editors. No funding was received in the publication of this article.
Cite: European Commission approval of upadacitinib 15 mg for the treatment of giant cell arteritis in adult patients. touchIMMUNOLOGY. 9 April 2025.
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