AbbVie announced a significant advancement in the treatment of giant cell arteritis (GCA) as the European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) recommended approval for upadacitinib (RINVOQ®). The recommendation specifically covers a 15 mg once-daily dose for adult patients with GCA, positioning it to become the first oral advanced therapy for this condition.
Breakthrough in GCA Treatment
The recommendation is supported by compelling data from the Phase 3 SELECT-GCA clinical trial, which evaluated upadacitinib's efficacy and safety in adults aged 50 and older with GCA. The study demonstrated the drug's ability to achieve sustained remission, defined as the absence of GCA signs and symptoms from week 12 through week 52, while adhering to protocol-defined steroid taper.
"Giant cell arteritis is an inflammatory disease that, if left untreated, can lead to severe outcomes like blindness, stroke or aortic aneurysm," explained Prof. Dr. med. Wolfgang Schmidt, M.D., MACR, from Waldfriede Hospital's Department of Rheumatology in Berlin and SELECT-GCA trial investigator. "This positive opinion recognizes the unmet need for adults living with giant cell arteritis."
Clinical Trial Design and Outcomes
The SELECT-GCA trial enrolled 428 patients, comparing upadacitinib (7.5 mg or 15 mg) combined with a 26-week corticosteroid taper regimen against placebo with a 52-week corticosteroid taper regimen. Throughout the 52-week, placebo-controlled period, upadacitinib maintained a safety profile consistent with its performance in other approved indications.
Understanding Giant Cell Arteritis
GCA, also known as temporal arteritis, is the most common vasculitis affecting adults in western countries. The condition primarily impacts medium and large arteries, causing inflammation of cranial arteries and the aorta. The disease predominantly affects white women over 50, with peak incidence between ages 70 and 80.
Treatment Implications
"The CHMP's positive opinion for upadacitinib represents a crucial step toward improving outcomes for patients suffering with this disease," said Kori Wallace, M.D., Ph.D., vice president and global head of immunology clinical development at AbbVie. "We remain committed to advancing standards of care for immune-mediated diseases and addressing unmet patient needs."
If approved by the European Commission, which is expected in the first half of 2025, RINVOQ will add GCA to its existing portfolio of approved indications in the EU, which includes various inflammatory conditions such as rheumatoid arthritis, psoriatic arthritis, and ulcerative colitis.
