Axial Spondyloarthritis

AbbVie’s Rinvoq (upadacitinib) has been approved by the US Food and Drug Administration (FDA) to treat adults with giant cell arteritis (GCA), or temporal arteritis, an autoimmune disease of medium and large arteries. The US regulator’s decision, which comes just three weeks after the European Commission approved Rinvoq for the same indication, was supported by results from the phase 3 SELECT-GCA trial. In the study, 46.4% of patients receiving Rinvoq 15mg in combination with a 26-week steroid taper regimen achieved sustained remission at week 52, compared to 29% of patients randomised to receive placebo alongside a 52-week steroid taper regimen. Additionally, data showed that 34.3% of patients being treated with the Rinvoq combination experienced at least one disease flare through week 52 versus 55.6% of patients in the placebo arm, and AbbVie’s drug was also associated with lower cumulative steroid exposure and sustained complete remission. Occurring most frequently in women aged over 50 years, GCA can cause headaches, jaw pain and visual disturbances such as vision loss, as well as large artery complications and cardiovascular disease. The current mainstay of treatment for the disease, glucocorticoids, can result in drug-associated toxicities, and relapse remains common. AbbVie’s Rinvoq is now the first and only oral Janus kinase (JAK) inhibitor to be approved in the US for adults with GCA, and could allow patients to taper off steroids. “This FDA approval will now provide an alternative treatment option that can offer patients with GCA the possibility of tapering off steroids and achieving sustained remission,” said Roopal Thakkar, executive vice president, research and development, chief scientific officer, AbbVie. SELECT-GCA trial investigator, Peter Merkel, University of Pennsylvania, added: “We now have a new option to treat GCA. The results of this clinical trial show that [Rinvoq] offers patients the chance to reach sustained remission.” Beyond GCA, Rinvoq is approved in the US to treat rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis, non-radiographic axial spondyloarthritis, ulcerative colitis and Crohn’s disease. The drug is also in phase 3 clinical development for alopecia areata, hidradenitis suppurativa, Takayasu arteritis, systemic lupus erythematosus and vitiligo.

The therapy was discovered and developed by AbbVie. Credit: © AbbVie Inc. All rights reserved. The European Commission (EC) has granted marketing authorisation for AbbVie’s once-a-day treatment Rinvoq (upadacitinib) 15mg for adults with giant cell arteritis (GCA). It is the first and only oral Janus kinase inhibitor approved in the European Union, Liechtenstein, Norway and Iceland, for this indication. GCA is an autoimmune condition, predominantly affecting individuals over 50, with the highest incidence between 70 and 80 years of age. The condition leads to the inflammation of the aorta, the temporal and cranial arteries, and other large and medium arteries. The authorisation of Rinvoq is based on data from the multicentre Phase III SELECT-GCA trial, which was structured to assess the efficacy and safety of the therapy in 428 GCA subjects. The trial met its primary and key secondary endpoints, demonstrating that 46.4% of subjects treated with 15 mg of the therapy plus a steroid taper regimen for 26 weeks achieved sustained remission at week 52 versus 29% of those on placebo with a steroid taper regimen. AbbVie research and development, chief scientific officer and executive vice-president Roopal Thakkar stated: “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.” The therapy has previously gained approval in the EU for conditions including psoriatic arthritis, radiographic axial spondylarthritis and Crohn’s disease. Rinvoq has been discovered and developed by company scientists and is currently under investigation for other immune-mediated inflammatory conditions. It is also undergoing Phase III trials for alopecia areata, hidradenitis suppurativa, Takayasu arteritis, vitiligo and systemic lupus erythematosus. In March 2025, the company announced a $2.3bn licensing agreement to acquire global rights to the long-acting amylin analogue, GUB014295, from Danish biotech Gubra.

AbbVie’s Rinvoq (upadacitinib) has been granted marketing authorisation by the European Commission (EC) to treat giant cell arteritis (GCA), making it the first oral Janus kinase (JAK) inhibitor to be approved in the EU for adults with the autoimmune disease. Also known as temporal arteritis, GCA causes inflammation of the temporal and other cranial arteries, the aorta and additional large and medium arteries. The disease typically affects people aged over 50 years, particularly women, and can cause headaches, jaw pain and visual disturbances such as vision loss, as well as large artery complications and cardiovascular disease. Rinvoq is already approved in the EU for certain cases of radiographic axial spondylarthritis, nonradiographic axial spondylarthritis, psoriatic arthritis, rheumatoid arthritis, ulcerative colitis, Crohn’s disease and atopic dermatitis. “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 co-morbidities,” said Roopal Thakkar, executive vice president, research and development, chief scientific officer, AbbVie. The regulator’s latest decision on the drug was based on positive results from the late-stage SELECT-GCA trial, in which 46.4% of patients being treated with Rinvoq in combination with a 26-week steroid taper regimen achieved sustained remission at week 52, compared with 29% of patients randomised to receive placebo alongside a 52-week steroid taper regimen. Data also showed that 34.3% of patients in the Rinvoq cohort experienced at least one disease flare through week 52 versus 55.6% of patients in the placebo arm, and AbbVie’s drug was associated with lower cumulative steroid exposure and sustained complete remission. SELECT-GCA trial investigator, Wolfgang Schmidt, Waldfriede Hospital, said: “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. “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.”