AbbVie’s JAK Inhibitor Rinvoq Achieves Positive Phase 3 Results in Giant Cell Arteritis, with Nearly Half of Patients Achieving Sustained Remission

Apr 19, 2024 07:44 CST Updated 07:45

AbbVie

Innovative Drug Developer

▎Edited by the WuXi AppTec content team

AbbVie Inc. announced today that its JAK inhibitor Rinvoq (upadacitinib) achieved positive topline results in the Phase 3 clinical trial SELECT-GCA. Rinvoq, in combination with a 26-week steroid taper regimen, met the primary endpoint of sustained remission from week 12 to week 52 in adult patients with giant cell arteritis (GCA). In this study,46% of patients treated with Rinvoq combined with a 26-week steroid tapering regimen achieved sustained remission., in contrast, this value was 29% (p=0.0019) in patients receiving placebo combined with a 52-week hormone tapering regimen.

GCA is an autoimmune disease that causes inflammation of the temporal arteries and other intracranial arteries, the aorta, and other large and medium-sized arteries. GCA typically affects elderly patients over 50 years old, with the most common age range being between 70 and 80. Women are at the highest risk of developing this condition. Symptoms may include headache, jaw pain, and changes in vision or vision loss, which can be sudden and permanent.

This study also achieved important secondary endpoints, includingPatients treated with Rinvoq in combination with a 26-week steroid tapering regimen achieved sustained complete remission from week 12 to week 52 at a higher rate than those in the control group (37% vs. 16%; p<0.0001).During the 52-week placebo-controlled period, the safety profile of Rinvoq was generally consistent with that observed in the approved indications. It was generally well-tolerated in patients with GCA, and no new safety signals were identified.

The full results of all treatment groups in the SELECT-GCA study will be presented at future medical conferences.Rinvoq, discovered and developed by scientists at AbbVie, is a JAK inhibitor used to treat various immune-mediated inflammatory diseases.Based on enzymatic and cellular analyses, Rinvoq demonstrates greater inhibitory potency against JAK1 than JAK2, JAK3, and TYK2. Rinvoq is currently being evaluated in Phase 3 clinical trials for conditions such as alopecia areata, giant cell arteritis, systemic lupus erythematosus, and vitiligo.

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References:

[1] Phase 3 SELECT-GCA Study of Upadacitinib (RINVOQ®) Showed Positive Results in Patients With Giant Cell Arteritis. Retrieved April 18, 2024, from 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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