A PHASE III clinical trial presented at ACR Convergence 2024 revealed that upadacitinib (UPA), combined with a 26-week glucocorticoid (GC) improved disease control and reduced steroid exposure compared to a placebo (PBO) regimen in patients with giant cell arteritis (GCA).
Key findings from the trial:
The SELECT-GCA trial evaluated upadacitinib (RINVOQ®, AbbVie, Chicago, Illinois, USA) in doses of 7.5 mg and 15 mg daily versus placebo, combined with distinct GC tapering protocols over 52 weeks. A total of 428 patients (aged ≥50 years) participated across 24 countries.
Efficacy:
• Sustained remission: 46% of patients receiving UPA15 achieved sustained remission at week 52 compared to 29% with PBO.
• Reduced flares: UPA15 decreased the risk of disease flare throughout the 52-week period.
• Improved fatigue scores: Patients on UPA15 reported better fatigue outcomes, as measured by FACIT-Fatigue.
Safety outcomes:
No new safety signals were identified with UPA as compared to its known safety profile.
• Rates of herpes zoster, lymphopenia, anemia, and nonmelanoma skin cancer were numerically higher with UPA15 than PBO.
• UPA groups reported no cases of MACE.
Clinical implications:
The authors suggest that UPA15 provides a favorable benefit-risk profile and represents a potential new oral targeted therapy for patients with GCA.
Reference: Merkel P et al. Efficacy and Safety of Upadacitinib in Patients with Giant Cell Arteritis (SELECT-GCA): A Double-Blind, Randomized Controlled Phase 3 Trial. Abstract 0770. ACR Convergence 2024, November 16-19, 2024.
Anaya Malik | AMJ
