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The US Food and Drug Administration (FDA) has approved a new indication for upadacitinib as a treatment for giant cell arteritis (GCA) in adults.

This is the first oral JAK inhibitor indicated for GCA, according to the drug manufacturer AbbVie. 

“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, MD, the executive vice president of research and development and the chief scientific officer at AbbVie, in a press release.

The European Commission approved upadacitinib for the treatment of GCA in adults in early April.

The approval was supported by results from the phase 3, multicenter, randomized SELECT-GCA trial, which enrolled 428 patients with GCA. In the trial, 46.5% of patients receiving 15 mg of upadacitinib daily in combination with a 26-week corticosteroid (CS) taper regimen achieved sustained remission from week 12 to week 52, compared with 29.0% of patients receiving placebo in combination with a 52-week CS taper regimen.

“Glucocorticoids remain a mainstay of treatment of GCA but lead to substantial drug-associated toxicities. Additionally, relapse remains common for patients with this disease,” said Peter A. Merkel, MD, MPH, chief of rheumatology at the University of Pennsylvania, Philadelphia, and SELECT-GCA trial investigator, in a press release. “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.”

The recommended dosage of upadacitinib is 15 mg once per day. Common side effects include upper respiratory tract infections, shingles (herpes zoster), herpes simplex virus infections (including cold sores), bronchitis, nausea, cough, fever, acne, headache, and swelling of the feet and hands (peripheral edema). The full list of side effects can be found here. 

This is the ninth indication for upadacitinib in the United States. First approved in 2019 for moderate-to-severe rheumatoid arthritis in adults, it is also indicated for adults with active psoriatic arthritis, active ankylosing spondylitis, active nonradiographic axial spondyloarthritis, moderate-to-severe ulcerative colitis, and moderate to severe Crohn’s disease. 

It is also approved for refractory atopic dermatitis in adults and children over 12 years, active polyarticular juvenile idiopathic arthritis in children 2 years and older, and active psoriatic arthritis in children 2 years and older.