AbbVie Releases Positive Topline Results from Upadacitinib Study for Giant Cell Arteritis

RINVOQ (upadacitinib) is a Janus Kinase inhibitor that is currently approved to treat a variety of conditions: moderate to severe atopic dermatitis, active psoriatis arthritis, moderate to severe rheumatoid arthritis, active ankylosing spondylitis, moderative to severe ulcerative colitis, moderate to severe Crohn’s disease, and active non-radiographic axial spondyloarthritis. Now researchers are looking into whether RINVOQ could be an option for people living with an inflammatory disorder called giant cell arteritis (GCA).

What is Giant Cell Arteritis?

Also known as: Temporal arteritis

Giant cell arteritis is a form of vasculitis; it causes blood vessel inflammation in the scalp and head, primarily around the temples. What causes this inflammation remains unknown. Doctors hypothesize that inflammation results from immune system abnormalities. This condition occurs in adults, most often in those ages 50 or older. It is also more common in females, Caucasians, and people with polymyalgia rheumatica. Giant cell arteritis may begin with symptoms such as appetite loss, fever, and fatigue. Later symptoms may include severe headaches, double vision, dizziness, coordination and balance issues, temple or scalp tenderness, jaw pain when eating or speaking, chest pain, dysphagia (difficulty swallowing), sore throat, and vision loss.

Early diagnosis and treatment are extremely important for giant cell arteritis because it can reduce the risk of vision loss or other long-term complications. Corticosteroids are the standard-of-care. Those affected must take high doses for at least one month before decreasing and tapering off. The FDA also approved ACTEMRA (tocilizumab) for giant cell arteritis to reduce the need for corticosteroids.

Phase 3 SELECT-GCA Study Results

On April 18, 2024, pharmaceutical company AbbVie shared that positive top-line data was available from the Phase 3 SELECT-GCA clinical trial. This study evaluated differing doses of once-daily RINVOQ for people with giant cell arteritis, with a 26-week steroid taper regimen. The findings show that 46% of individuals receiving this treatment regimen achieved sustained remission – 17% higher than those taking a placebo. Additionally, people in the RINVOQ group experienced less flares. It is important to note that these results occurred in those taking 15mg RINVOQ; the 7.5mg cohort did not meet the study’s primary or secondary endpoints.

When considering the 15mg cohort, researchers also found that the treatment had solid tolerability, though 15% of participants taking RINVOQ discontinued the trial due to adverse reactions. However, discontinuation was more common in those receiving the placebo, with 21% of participants discontinuing. Researchers still consider RINVOQ to be safe.

While these results are positive, they are not yet complete. Additional data will most likely be available later this year or early next year.

Jessica Lynn

Jessica Lynn

Jessica Lynn has an educational background in writing and marketing. She firmly believes in the power of writing in amplifying voices, and looks forward to doing so for the rare disease community.

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