In year 2 of SELECT-GCA, 6.0% of patients continuing upadacitinib flared vs 55.9% switched to placebo.
Upadacitinib flare rates and characteristics in SELECT-GCA period 2
Patients with giant cell arteritis (GCA) who continued upadacitinib (Rinvoq) 15 mg for a second year had fewer, less severe flares than those switched to placebo, according to a 2-year analysis of the phase 3 SELECT-GCA trial presented at the
Upadacitinib 15 mg was approved for GCA in April 2025 based on period 1 of SELECT-GCA, in which the Janus kinase (JAK) inhibitor with a 26-week glucocorticoid taper improved sustained remission vs placebo with a 52-week taper.² Like most GCA trials, period 1 ended at one year, leaving the question of what happens after treatment stops.
“What’s really nice to know is what happens after that year,” said Anisha B. Dua, MD, MPH, professor of medicine at Northwestern University and a coauthor of the analysis, in an interview with RheumatologyLive. “We kind of actually get to see what happens if you stay on the drug or don’t stay on the drug.”
In period 2, patients receiving upadacitinib who sustained remission from weeks 28 to 52 were rerandomized 2:1 to continue their dose or switch to placebo.¹ The analysis, led by Christian Dejaco, MD, PhD, focused on patients receiving upadacitinib 15 mg who were off glucocorticoids at period 2 entry.¹
Glucocorticoid use and inflammatory markers during GCA flares on upadacitinib
Among patients who flared, severe flares occurred in 25.0% (1/4) continuing upadacitinib vs 42.1% (8/19) switched to placebo.¹ No patient continuing upadacitinib had a second flare, compared with three patients switched to placebo.¹
The mean initial glucocorticoid dose used to treat the first flare was 9.4 mg (standard deviation [SD], 4.3) with continued upadacitinib vs 26.3 mg (SD, 18.0) after switching to placebo.¹ Most flares in both groups involved both recurrent GCA signs or symptoms and erythrocyte sedimentation rate (ESR) elevation, occurring in 75.0% (3/4) and 52.6% (10/19), respectively.¹
From period 2 entry to first flare, mean C-reactive protein (CRP) rose by 0.7 mg/dL vs 2.2 mg/dL, and mean ESR rose by 26.0 mm/h vs 53.6 mm/h.¹ The investigators noted acute phase reactants remained useful for flare detection on upadacitinib, unlike with interleukin-6 inhibitors, which suppress them.¹
“I think we know that the disease doesn’t end after a year, so it’s not shocking that if you stop a medicine after one year, things aren’t necessarily going to go well,” Dua said. “This reiterates that, and gives you more reason to continue [the medication], especially if somebody’s tolerating it well.”
The flare counts in the continued-upadacitinib group were small, and the abstract did not report hazard ratios or P values. SELECT-GCA was sponsored by AbbVie, and several authors are AbbVie employees.¹
Dua’s disclosures include Amgen, Abbvie, Astra Zeneca, Novartis, GSK, Sanofi, Zenas, Novartis, Rheumatology Research Foundation, Sebastian Unizony IQVIA, PTC Therapeutics, and Harvard Pilgrim Healthcare.
