On April 18, AbbVie announced positive results from SELECT-GCA. Based on the results of this Phase 3, multicenter, randomized, double-blind, placebo-controlled study, upadacitinib (RINVOQ®; 15 mg once daily) in combination with a 26-week hormone tapering regimen met the primary endpoint of sustained remissiona in adult patients with giant cell arteritis (GCA) from Week 12 to Week 52. In this study, 46% of patients treated with Rinvoq in combination with the 26-week hormone tapering regimen achieved sustained remission, compared to 29% of patients treated with placebo in combination with the 52-week hormone tapering regimen (p=0.0019).

Dr. Kori Wallace, Vice President, Global Head of Clinical Development, Immunology at AbbVie, said, "Many patients with GCA continue to suffer from the potentially debilitating symptoms of the disease, and their treatment options are limited. These results demonstrate that there remains a significant medical need for this type of disease, and we are relentlessly committed to improving the lives of patients with immune-mediated diseases through the development of new treatments."

GCA is an autoimmune disease that causes inflammation of the temporal and other intracranial arteries, the aorta, and other large and medium-sized arteries.GCA typically affects older patients over the age of 50, with the most common age group being between 70 and 80. Women are at the highest risk of developing the disease, and symptoms may include headaches, jaw pain, and changes or loss of vision, which may be sudden and permanent.

This study also met several key secondary endpoints, including a significantly higher proportion of patients treated with Rinvoq in combination with a 26-week hormone tapering regimen achieved a sustained complete remissionb from weeks 12 through 52 than did patients in the control group (37% versus 16%; p<0.0001). A lower proportion of patients in the 15 mg upadacitinib group experienced at least one disease flare at week 52 compared to the placebo group (34% versus 56%; p=0.0014). The findings also showed that 7.5mg upadacitinib did not meet the primary or any of the secondary endpoints.

"I am encouraged by these results, which provide additional evidence to support the efficacy and safety of upadacitinib in the treatment of rheumatic diseases," said Dr. Daniel Blockmans, Professor of Medicine at the University of Leuven, Belgium, and Principal Investigator of the SELECT-GCA study.GCA is an inflammatory disease of the large arteries that primarily affects older adults, for which only one treatment has been approved to date, usually in conjunction with hormones. Based on the results of the study, upadacitinib has the potential to be the first oral therapeutic drug option for patients with GCA.

During the 52-week placebo-controlled period, the safety profile of upadacitinib 15 mg was generally consistent with that observed in the approved indications and was generally well tolerated, with no new safety signals identified in patients with GCA.

Complete results from all treatment arms of the SELECT-GCA study will be presented at a future medical meeting.The use of upadacitinib in GCA is not yet approved, and its safety and efficacy have not yet been evaluated by regulatory agencies.
DISCLAIMER: This article is for informational purposes only. Upadacitinib for GCA is still under investigation and has not been approved in China. AbbVie does not recommend the use of any unapproved drugs or indications.

a Sustained remission is defined as the absence of signs and symptoms of GCA from Week 12 to Week 52 and adherence to a hormone tapering regimen as defined by the protocol during the study period.

b Sustained complete remission was defined as the absence of signs and symptoms of GCA from Week 12 to Week 52, adherence to the protocol-defined hormone tapering regimen, and normalization of erythrocyte sedimentation rate (ESR) and high-sensitivity C-reactive protein (hsCRP) from Week 12 to Week 52.

About SELECT-GCA
SELECT-GCA (M16-852) is a Phase 3, multicenter, randomized, double-blind, placebo-controlled study to evaluate the safety and efficacy of upadacitinib in 428 patients with GCA. The study consisted of two phases. The first phase reported herein assessed the effectiveness of upadacitinib combined with a 26-week hormone tapering regimen versus placebo combined with a 26-week hormone tapering regimen. In addition, the study evaluates the safety and tolerability of upadacitinib in these patients. Phase 2 will evaluate the safety and efficacy of continuing upadacitinib versus maintaining sustained remission after withdrawing upadacitinib in participants who achieved sustained remission in Phase 1.

About Giant Cell Arteritis
Giant cell arteritis (GCA), also known as temporal arteritis, is an autoimmune disease of the middle and large arteries characterized by granulomatous inflammation in the walls of the triad of blood vessels involving the temporal and other cranial arteries, as well as the aorta and other large arteries.GCA can cause headaches, jaw pain, and changes or loss of vision, including sudden and permanent loss of vision, and it is the most common form of White women over the age of 50 (most commonly between the ages of 70 and 80) are at the highest risk of developing giant cell arteritis. Although women are more likely to develop GCA than men, studies have shown that men are more likely to have eye symptoms.

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