Phase III SELECT-GCA Trial for Rinvoq Yields Promising Results in Treating Patients with Giant Cell Arteritis

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Results from the Phase III SELECT-GCA study evaluating AbbVie’s Rinvoq (upadacitinib) in combination with a steroid taper regimen showed sustained remission treating adults with giant cell arteritis (GCA). According to the company, the trial achieved its primary endpoint, with 46% of patients experiencing sustained remission compared to only 29% achieving sustained remission from a placebo. The trial also achieved key secondary endpoints, including a higher percentage of patients administered upadacitinib 15 mg in combination with a 26-week steroid taper regimen able to maintain remission by week 52.¹

"Many people living with GCA continue to suffer from the potentially debilitating symptoms of this disease, with limited treatment options available to them," said Kori Wallace, MD, PhD, VP, global head, immunology clinical development, AbbVie, in a press release. "These results demonstrate our relentless commitment to improving the lives of people living with immune-mediated diseases by developing new treatments where significant medical needs still exist."

Last May, Rinvoq was approved by the FDA to treat patients with moderately to severely active Crohn disease as a once-daily pill. Previously, Rinvoq was given approval across six other indications, including rheumatology, dermatology, and gastroenterology. It was first approved in 2019 as an oral Janus kinase inhibitor for the treatment of patients with moderately to severely active rheumatoid arthritis who have had an inadequate response or intolerance to methotrexate.^2,3

"The discovery and development of Rinvoq is indicative of AbbVie's long-standing commitment to advancing the science for people living with immune-mediated conditions," said Michael Severino, MD, vice chairman, president, AbbVie, in a 2019 press release. "Today's FDA approval marks an important milestone in our pursuit to deliver innovative medicines that advance care for people living with rheumatoid arthritis."

According to the Arthritis Foundation, early symptoms of GCA usually include fatigue, loss of appetite, and fever. More specifically, symptoms that come with inflated arteries to the head include, but aren’t limited to double vision, severe headaches, jaw pain, vision loss, issues with swallowing, and scalp tenderness.⁴

“The cause of GCA is uncertain but it is believed to be an autoimmune disease in which the body’s own immune system attacks the blood vessels, including the temporal arteries, which supply blood to the head and the brain. Genetic and environmental factors (such as infections) are thought to play important roles,” reports the Arthritis Foundation. “Because it is rare in people under age 50, its development could be linked to the aging process.”

Based on results from the SELECT-GCA study, AbbVie stated that Rinvoq is on track to become the first oral treatment approved for GCA.¹

"I am encouraged by these results, which add to the body of evidence supporting the efficacy and safety profile of upadacitinib for the treatment of rheumatic diseases," said SELECT-GCA trial lead investigator Daniel Blockmans, MD, PhD, department of general internal medicine, University Hospitals Gasthuisberg, Belgium, professor of medicine, KU Leuven, Belgium, in the press release. "Based on these results, upadacitinib has the potential to be the first oral treatment option for patients with GCA, a disease with inflammation of the large arteries that primarily impacts older people and has only one approved treatment to date3 commonly used with steroids."

References

1. Phase 3 SELECT-GCA Study of Upadacitinib (RINVOQ®) Showed Positive Results in Patients With Giant Cell Arteritis. AbbVie. April 18, 2024. Accessed April 18, 2024. https://news.abbvie.com/2024-04-18-Phase-3-SELECT-GCA-Study-of-Upadacitinib-RINVOQ-R-Showed-Positive-Results-in-Patients-With-Giant-Cell-Arteritis

2. U.S. FDA Approves RINVOQ® (upadacitinib) as a Once-Daily Pill for Moderately to Severely Active Crohn's Disease in Adults. AbbVie. May 18, 2023. Accessed April 18, 2024. https://news.abbvie.com/2023-05-18-U-S-FDA-Approves-RINVOQ-R-upadacitinib-as-a-Once-Daily-Pill-for-Moderately-to-Severely-Active-Crohns-Disease-in-Adults

3. AbbVie Receives FDA Approval of RINVOQ™ (upadacitinib), an Oral JAK Inhibitor For The Treatment of Moderate to Severe Rheumatoid Arthritis. AbbVie. August 16, 2019. Accessed April 18, 2024. https://news.abbvie.com/2019-08-16-AbbVie-Receives-FDA-Approval-of-RINVOQ-TM-upadacitinib-an-Oral-JAK-Inhibitor-For-The-Treatment-of-Moderate-to-Severe-Rheumatoid-Arthritis

4. Giant Cell Arteritis. Arthritis Foundation. Accessed April 18, 2024. https://www.arthritis.org/diseases/giant-cell-arteritis