Phase 3 Upadacitinib Study Achieves Positive Results for the Treatment of Giant Cell Arteritis

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Results of the SELECT-GCA study demonstrated approximately half of patients with giant cell arteritis treated with upadacitinib plus a steroid tapering regimen were able to achieve sustained remission through week 52.

Phase 3 Upadacitinib Study Achieves Positive Results for the Treatment of Giant Cell Arteritis

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The SELECT-GCA study demonstrated 46% of patients with giant cell arteritis (GCA) treated with 15 mg upadacitinib plus a 26-week steroid taper regimen were able to achieve sustained remission from week 12 through week 52, according to a press release from Abbvie.1 These results compared with 29% of patients receiving a placebo plus 52-week steroid taper regimen proved the superiority of treatment with upadacitinib among this patient population (P = .0019).

Upadacitinib, a Janus kinase (JAK) inhibitor, is used to treat a number of autoimmune conditions including adults with moderate to severe rheumatoid arthritis (RA), active psoriatic arthritis (PsA), ankylosing spondylitis (AS), non-radiographic axial spondyloarthritis (nr-axSpA), moderate to severe ulcerative colitis, and moderate to severe Crohn’s disease.

"Many people living with GCA continue to suffer from the potentially debilitating symptoms of this disease, with limited treatment options available to them," Kori Wallace, MD, PhD, vice president, global head of immunology clinical development, AbbVie, said in a statement. "These results demonstrate our relentless commitment to improving the lives of people living with immune-mediated diseases by developing new treatments where significant medical needs still exist."1

The Trial

SELECT-GCA is a phase 3, multicenter, randomized, double-blind, placebo-controlled study designed to evaluate the safety and efficacy of the drug among a cohort of 428 patients with GCA. The first portion of the study evaluated the drug plus a 26-week corticosteroid taper regimen compared with placebo plus a 52-week corticosteroid taper regimen.

The second period is set to evaluate the safety and efficacy of continuing the drug compared with withdrawing upadacitinib in maintaining remission for patients who were able to obtain sustained remission during the first period of the study.

Sustained remission was defined as having no signs or symptoms of GCA from week 12 through week 52 as well as adherence to the steroid tapering protocol. Complete remission also included the normalization of both erythrocyte sedimentation rate (ESR) and high sensitivity C-reactive protein (hsCRP) from week 12 through week 52.

Safety endpoints were consistent with those in other approved indications. The drug was well tolerated, and no new safety signals were reported. Adverse events culminating in discontinuation of the drug occurred in 15% of patients receiving upadacitinib 15 mg and 21% of patients in the placebo group. The proportion of patients experiencing a serious adverse event were comparable among both groups and serious infections occurred in 6% of those receiving upadacitinib and 11% of those in the placebo cohort. No major adverse cardiac events (MACE) were reported in the upadacitinib group.

Common side effects of upadacitinib include upper respiratory tract infections, shingles, nausea, cough, headache, abdominal pain, fatigue, fever, tuberculosis and other viral, bacterial, or fungal infections. Allergic reactions to the drug include the swelling of the lips, tongue, or throat, hives, trouble breathing, and feeling faint or dizzy.

A higher percentage of patients in the upadacitinib cohort obtained sustained complete remission compared with the placebo cohort (37% vs 16%, respectively; P <.0001). Additionally, a lower percentage of patients reported ≥ 1 disease flare through week 52 in the upadacitinib group compared with placebo (34% vs 56%, respectively; P = .0014).

About GCA

GCA, also known as temporal arteritis, generally impacts patients aged > 50 years and causes inflammation of the temporal and other cranial arteries, large and medium arteries, and the aorta. Common symptoms of the autoimmune disease include changes in vision or vision loss—which can be sudden and permanent—headache, and jaw pain. It is the most common form of vasculitis affecting adult patients in Western countries.

"Based on these results, upadacitinib has the potential to be the first oral treatment option for patients with GCA, a disease with inflammation of the large arteries that primarily impacts older people and has only one approved treatment to date3 commonly used with steroids,” lead investigator Daniel Blockmans, MD, PhD, professor of medicine at KU Leuven in Belgium and associated with the Department of General Internal Medicine at University Hospitals Gasthuisberg, said in a statement.1

References

  1. AbbVie. Phase 3 select-GCA study of upadacitinib (RINVOQ®) showed positive results in patients with giant cell arteritis. PR Newswire: press release distribution, targeting, monitoring and marketing. April 18, 2024. Accessed April 18, 2024. https://www.prnewswire.com/news-releases/phase-3-select-gca-study-of-upadacitinib-rinvoq-showed-positive-results-in-patients-with-giant-cell-arteritis-302120893.html.
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