On April 8, AbbVie announced that the European Union has approved RINVOQ? (upadacitinib; 15 mg once daily) for the treatment of adult patients with giant cell arteritis (GCA). RINVOQ is the first and only oral Janus kinase (JAK) inhibitor approved in the European Union (EU), Iceland, Liechtenstein, and Norway for the treatment of adult patients with GCA.
The approval is based on data from the pivotal Phase 3 SELECT-GCA trial, which demonstrated that RINVOQ met the primary endpoint of sustained remission* as well as key secondary endpoints, including reduced disease relapse, decreased cumulative steroid exposure, and sustained complete remission.
"GCA is a challenging and often debilitating disease. Patients may experience headaches, jaw pain, and muscle aches, and many fear sudden and permanent vision loss," said Prof. Dr. med. Wolfgang Schmidt, MACR, a rheumatologist at Waldfriede Hospital in Berlin, Germany and investigator in the SELECT-GCA trial. "The results of the SELECT-GCA trial showed that patients treated with RINVOQ achieved sustained remission and reduced their cumulative steroid exposure, addressing important treatment goals for GCA."
GCA is an autoimmune disease characterized by inflammation of the temporal and other cranial arteries, the aorta, and other large- and medium-sized arteries. It typically affects patients over the age of 50 and is most common between ages 70 and 80.
"The EC’s approval of RINVOQ for the treatment of GCA provides a new therapeutic option for patients and physicians, and marks the first advanced oral treatment for adult GCA patients—a particularly vulnerable population due to age and comorbidities," said Dr. Roopal Thakkar, Executive Vice President, Research and Development and Chief Scientific Officer, AbbVie. "This exciting milestone highlights our continued commitment to expanding indications in areas of high unmet need to help patients achieve better outcomes, including sustained disease remission."
The EC's approval is based on data from the Phase 3 SELECT-GCA trial recently published in the New England Journal of Medicine. In the trial, RINVOQ 15 mg combined with a 26-week steroid tapering regimen met both the primary and key secondary endpoints compared to placebo combined with a 52-week steroid tapering regimen.
During the 52-week placebo-controlled period, the safety profile of RINVOQ was consistent with that observed in other approved indications2. The incidence of serious adverse events was similar between the RINVOQ and placebo groups1. Serious infections occurred in 5.7% of RINVOQ patients versus 10.7% in the placebo group1. Incidences of malignancies (excluding non-melanoma skin cancer; 1.9% for RINVOQ vs. 1.8% for placebo) and venous thromboembolism (3.3% vs. 3.6%) were balanced across treatment groups1.
No adjudicated major adverse cardiovascular events (MACE) occurred in the RINVOQ group, while two events were reported in the placebo group1. Four deaths occurred during the treatment period: two in the placebo group and two in the RINVOQ 15 mg group. Among the RINVOQ deaths, one was attributed to COVID-19, and the other was of unknown cause.
RINVOQ is already approved in the EU for the treatment of adult patients with radiographic axial spondyloarthritis, non-radiographic axial spondyloarthritis, psoriatic arthritis, rheumatoid arthritis, ulcerative colitis, Crohn’s disease, and adult and adolescent patients with atopic dermatitis—now including adult patients with GCA.
|
3YRS
