Patients with relapsing GCA who stopped upadacitinib after year 1 flared sooner and needed far more glucocorticoids than new-onset patients.
Upadacitinib withdrawal in new-onset vs relapsing giant cell arteritis
Continuing upadacitinib (Rinvoq) 15 mg through 2 years reduced flare risk by at least 90% vs placebo in both new-onset and relapsing giant cell arteritis (GCA), but relapsing patients withdrawn from treatment flared sooner and required substantially more glucocorticoids, according to a SELECT-GCA analysis presented at
The analysis, led by Anisha B. Dua, MD, MPH, of Northwestern University, examined whether baseline disease status shapes the risk of stopping the Janus kinase (JAK) inhibitor after the first year.¹ Upadacitinib was approved for GCA in April 2025 based on period 1 results.²
“We’re always looking for characteristics that might increase your risk of relapse if you do stop the drug, or decrease your risk of relapse,” Dua told Rheumatology Live. “That way you can have those conversations with patients.”
In period 1, patients received upadacitinib 15 mg with a 26-week glucocorticoid taper or placebo with a 52-week taper.¹ Of 103 patients receiving upadacitinib who entered period 2, 68 continued treatment and 35 switched to placebo, and 72.8% (75/103) had new-onset disease.¹
Upadacitinib reduced flare risk by at least 90% vs placebo in both subgroups.¹ Among patients switched to placebo, the relapsing subgroup had a notably shorter time to first flare and numerically lower remission rates than the new-onset subgroup.¹
Glucocorticoid exposure and safety by GCA subgroup in year 2
From weeks 52 to 104, median cumulative glucocorticoid exposure was 2297 mg in relapsing patients switched to placebo vs 110 mg in new-onset patients switched to placebo.¹ Patients continuing upadacitinib required a median of 0 mg in both subgroups.¹
Serious treatment-emergent adverse events (AEs) were generally similar between upadacitinib and placebo.¹ Among patients receiving upadacitinib, herpes zoster occurred at 7.2 vs 1.3 events per 100 patient-years in new-onset vs relapsing patients, which the investigators attributed to intensive initial treatment and higher glucocorticoid doses in new-onset disease.¹
Four treatment-emergent deaths occurred, 2 with upadacitinib and 2 with placebo, all in the new-onset subgroup.¹ Major cardiovascular AEs occurred in no patients receiving upadacitinib and 2 receiving placebo, and no new safety risks were identified.¹
“I would not stop at 1 year, ideally, unless there was a major reason to do so, but at least you can have a better conversation with patients about what their risk might be if they came into treatment initially with new-onset or relapsing disease,” Dua said. “I would probably be more hesitant to try to stop sooner in those with relapsing disease.”
The relapsing subgroup included about 28 patients, and the analysis was post hoc. “It is a small sample,” Dua said. “It’s still more data than we have after the 1-year mark on most of our trials.”
Relevant disclosures include Abbvie.
