Jason Laday , 2025-04-29 17:31:00
April 29, 2025
2 min read
Key takeaways:
- The FDA has approved upadacitinib to treat adults with giant cell arteritis.
- It is the second drug to be specifically approved for the disease in the United States after tocilizumab in 2017.
The FDA has approved the Janus kinase inhibitor upadacitinib for the treatment of giant cell arteritis in adults, the first such approval in the disease since tocilizumab received the green light in 2017, according to a press release.
The decision, allowing adults with GCA to receive 15 mg of upadacitinib (Rinvoq, AbbVie) once daily, represents the debut of a “new class of drugs” for GCA, according to Kenneth Warrington, MD, a rheumatologist, John F. Finn Minnesota Arthritis Foundation professor of medicine and director of the Vasculitis Clinic at the Mayo Clinic, in Rochester, Minnesota.
“It is the first of a new class of drugs for giant cell arteritis,” he said. “This oral medication aims to maintain patients in remission while reducing relapses and glucocorticoid use. Reducing glucocorticoid use is beneficial because glucocorticoids can lead to various side effects, such as increased risk of infections, weight gain and bone loss. Therefore, having an oral medication that can potentially decrease reliance on glucocorticoids is a significant advancement.”
Roopal Thakkar, MD, AbbVie’s executive vice president of research and development and chief scientific officer, said in the release that the approval will help providers better limit their patients’ steroid exposure. Reducing glucocorticoid use in GCA — due to a host of related toxicities and adverse effects — has long been a goal for rheumatologists.
“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,” Thakkar said in the release. “With this new indication for Rinvoq, we are underscoring AbbVie’s commitment to exploring how we can identify and address unmet needs for patients with immune-mediated diseases.”
According to AbbVie, the FDA’s decision was supported by results from the phase 3 SELECT-GCA trial, which were presented as late-breaking data at the EULAR 2024 Congress in Vienna. The double-blind, placebo-controlled study compared the efficacy and safety of upadacitinib with placebo in combination with a glucocorticoid taper regimen, in a cohort of 428 patients with GCA. Primary endpoint results showed that upadacitinib bested placebo in terms of sustained remission at week 52 — 46.6% vs. 29% (P = .002).
In addition, 52-week safety data suggested a profile “generally consistent with that observed in other approved indications,” according to AbbVie.
Researchers in the trial plan to further assess safety and efficacy of continuing Upadacitinib, vs. withdrawal, in maintaining remission in patients who achieved sustained remission in the above results.
According to Warrington, patients who use upadacitinib may be at increased risk for infections, cardiac events and blood clots.
“It is essential to use upadacitinib in the right population due to concerns about adverse effects,” he said. “As with any medication, careful consideration and monitoring are necessary to ensure patient safety and efficacy.”
The FDA previously approved subcutaneous tocilizumab (Actemra, Genentech) as the first ever drug specifically to treat GCA in May 2017. However, many rheumatologists have continued to rely on glucocorticoids as the “mainstay” to treat this disease.
Peter A. Merkel
“Glucocorticoids remain a mainstay of treatment of GCA but lead to substantial drug-associated toxicities,” Peter A. Merkel, MD, MPH, chief of rheumatology at the University of Pennsylvania, and SELECT-GCA trial investigator, said in the release. “Additionally, relapse remains common for patients with this disease. We now have a new option to treat GCA. The results of this clinical trial show that upadacitinib offers patients the chance to reach sustained remission.”
Sources/Disclosures
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Disclosures:
Warrington reports consulting fees from Sanofi and Amgen. Thakkar reports employment with AbbVie. Merkel reports research funding from AbbVie.
