European Commission expands upadacitinib (Rinvoq) indication to include giant cell arteritis

The approval represents the eighth approved indication for upadacitinib in the EU, alongside radiographic axial spondylarthritis, psoriatic arthritis, rheumatoid arthritis and other conditions. Image credit: ©C Coetzee/peopleimages.com – stock.adobe.com

On Wednesday, AbbVie announced that the European Commission (EC) expanded the indication for upadacitinib 15mg (Rinvoq) to include the treatment of giant cell arteritis (GCA). GCA, also known as temporal arteritis, is an autoimmune disease characterised by inflammation of medium and large arteries. Patients with GCA may experience sudden vision changes or loss of vision, including permanent vision loss.¹

According to the press release from AbbVie, upadacitinib is a janus kinase (JAK) inhibitor, and the first oral advanced therapy for patients with GCA. It is the only oral JAK inhibitor approved in the EU, Iceland, Liechtenstein and Norway for the treatment of GCA in adult patients. The approval represents the eighth approved indication for upadacitinib in the European Union.

GCA involves granulomatous inflammation of the three-layered vessel wall, which affects the aorta as well as the temporal and other cranial arteries. Along with vision changes, GCA can cause headaches or jaw pain. According to the press release from AbbVie, men are more likely to experience ocular manifestations of GCA, though White women between the ages of 70 and 80 have the highest risk of developing the common form of vasculitis.

The EC decision follows the release of study findings from the recently-published Phase 3 SELECT-GCA trial. Investigators found upadacitinib met its primary and key secondary endpoints for treatment of GCA including sustained remission, reduction in disease flares and lower cumulative steroid exposure.¹

"GCA is a challenging and often debilitating condition. Patients may endure headaches, jaw pain and muscle aches, with many fearing sudden and permanent vision loss," said Wolfgang Schmidt, MD, MACR, of the Waldfriede Hospital Department of Rheumatology, Berlin, Germany. Prof Schmidt served as a trial investigator in the SELECT-GCA study. "Results from the SELECT-GCA trial show that patients can achieve sustained remission and reduce their cumulative steroid exposure with RINVOQ, addressing important patient goals in the treatment of GCA."

SELECT-GCA (M16-852) is a Phase 3, multicenter, randomised, double-blind placebo-controlled study designed to evaluate the safety and efficacy of upadacitinib in 428 patients with GCA. The first part of the study evaluated the efficacy of upadacitinib in combination with a 26-week corticosteroid taper regimen; these results were compared with placebo in combination with a 52-week corticosteroid taper regimen. Topline results from this segment of the study were shared in April 2024, AbbVie reported.

"The EC approval of RINVOQ in GCA provides patients and physicians with a new treatment option and the first oral advanced therapy for adults living with GCA—a particularly vulnerable population due to older age and frequent comorbidities," said Roopal Thakkar, MD, executive vice president of research and development and chief scientific officer at AbbVie. "This exciting milestone demonstrates our commitment to ongoing research and expanding indications in areas of high unmet need to help patients achieve better outcomes, including sustained disease remission."

According to AbbVie, upadacitinib is also approved in the EU for the treatment of adults with radiographic axial spondylarthritis, nonradiographic axial spondylarthritis, psoriatic arthritis, rheumatoid arthritis, ulcerative colitis and Crohn disease, and for both adults and adolescents with atopic dermatitis.

Reference

AbbVie Announces European Commission Approval of RINVOQ® (upadacitinib) for the Treatment of Adults with Giant Cell Arteritis. AbbVie. Press release. Published April 8, 2025. Accessed April 8, 2025. https://news.abbvie.com/2025-04-08-AbbVie-Announces-European-Commission-Approval-of-RINVOQ-R-upadacitinib-for-the-Treatment-of-Adults-with-Giant-Cell-Arteritis