Today, AbbVie announced that it has submitted applications to the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA) for a new indication for upadacitinib (RINVOQ®; 15 mg, once daily) to treat adult patients with giant cell arteritis (GCA).
GCA is an autoimmune disease affecting medium and large arteries, leading to symptoms such as headache, jaw pain, and changes in vision, including sudden and permanent loss of vision.
“Currently, there are few approved treatment options for patients with GCA. Most patients are managed with glucocorticoids, and many cannot discontinue them without the recurrence of GCA symptoms,” said Roopal Thakkar, M.D., executive vice president, research and development, and chief scientific officer at AbbVie. “We recognize the importance of maintaining remission and limiting glucocorticoid use in GCA.”
The regulatory submissions are based on results from the SELECT-GCA Phase 3 study, which evaluated the safety and efficacy of upadacitinib in GCA patients. SELECT-GCA
SELECT-GCA (M16-852) is a Phase 3, multicenter, randomized, double-blind, placebo-controlled study involving 428 patients with GCA. The study consists of two periods. The first period assessed the efficacy of upadacitinib combined with a 26-week corticosteroid taper regimen versus a placebo with a 52-week corticosteroid taper regimen, along with safety and tolerability. The second ongoing period evaluates the safety and efficacy of continuing versus withdrawing upadacitinib in maintaining remission in patients who achieved sustained remission in the first period. More information is available on ClinicalTrials.gov (Identifier NCT03725202).
Giant cell arteritis (GCA), also known as temporal arteritis, is an autoimmune disease of medium and large arteries characterized by granulomatous inflammation of the vessel walls, affecting temporal and other cranial arteries as well as the aorta and other large arteries. GCA can cause headache, jaw pain, and changes in or loss of vision, including sudden and permanent vision loss. Caucasian women over 50 years old, particularly those aged 70 to 80, are at the highest risk of developing GCA. While women are more likely to develop GCA, men are more prone to ocular manifestations of the disease.
Discovered and developed by AbbVie, RINVOQ is a JAK inhibitor under investigation for several immune-mediated inflammatory diseases. In enzymatic and cellular assays, RINVOQ showed greater inhibitory potency for JAK-1 compared to JAK-2, JAK-3, and TYK-2. The relevance of this inhibition to therapeutic effectiveness and safety is not fully understood. Upadacitinib (RINVOQ) is currently being studied in Phase 3 trials for various conditions including alopecia areata, hidradenitis suppurativa, Takayasu arteritis, systemic lupus erythematosus, and vitiligo. The use of upadacitinib in GCA is not approved, and its safety and efficacy have not been evaluated by regulatory authorities.
RINVOQ® (upadacitinib) U.S. Uses and Important Safety Information
RINVOQ is a prescription medicine used to treat:
- Adults with moderate to severe rheumatoid arthritis (RA) when TNF blockers have not worked well or could not be tolerated.
- Adults with active psoriatic arthritis (PsA) when TNF blockers have not worked well or could not be tolerated.
- Adults with active ankylosing spondylitis (AS) when TNF blockers have not worked well or could not be tolerated.
- Adults with active non-radiographic axial spondyloarthritis (nr-axSpA) with objective signs of inflammation when TNF blockers have not worked well or could not be tolerated.
- Adults with moderate to severe ulcerative colitis (UC) when TNF blockers have not worked well or could not be tolerated.
- Adults with moderate to severe Crohn’s disease (CD) when TNF blockers have not worked well or could not be tolerated.
- Adults and children 12 years and older with moderate to severe eczema (atopic dermatitis) that did not respond to previous treatment and is not well controlled with other pills or injections, or when other pills or injections are not recommended.
- Children 2 years and older with active polyarticular juvenile idiopathic arthritis (pJIA) or active psoriatic arthritis (PsA) when TNF blockers have not worked well or could not be tolerated.
Important Safety Information
RINVOQ may cause serious side effects, including:
- Serious infections, including tuberculosis (TB), that can spread throughout the body and may cause death.
- Increased risk of death in people 50 years and older with at least one cardiovascular risk factor.
- Cancer and immune system problems, including lymphoma and other cancers.
- Increased risk of major cardiovascular events in people 50 years and older with at least one cardiovascular risk factor.
- Blood clots, which can be life-threatening and cause death.
- Allergic reactions.
- Tears in the stomach or intestines.
- Changes in certain laboratory tests.
Patients should not take RINVOQ if allergic to upadacitinib or any of its ingredients. RINVOQ should be taken as prescribed by a healthcare provider, and patients should inform their healthcare provider of any infections, heart problems, cancers, or other medical conditions before starting treatment.
For more information, including detailed safety information and prescribing details, visit the official RINVOQ website or consult a healthcare provider.
