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Upadacitinib 15 mg demonstrated convincing results as a treatment for giant cell arteritis in the phase 3 SELECT-GCA trial.
At a dose of 15 mg, upadacitinib showed convincing results as a treatment for giant cell arteritis (GCA) in the phase 3 SELECT-GCA trial. Sustained remission was achieved by 46.4% of participants on the JAK inhibitor compared with 29% on placebo.
The multinational, randomized-controlled, phase 3 SELECT-GCA trial (NCT03725202) assessed upadacitinib for GCA, an indication with still limited treatment options. Daniel Blockmans, MD, presented the 1-year results of the study, which included two periods of 52 weeks.
The participants (n=428) had a mean age of around 71 years, were mostly women, and 70% had new onset GCA. They were randomized to upadacitinib at 15 mg or 7.5 mg or placebo with a 52-week tapering of glucocorticosteroids. “The primary endpoint was sustained remission with the absence of signs and symptoms from GCA from week 12 through week 52. In addition, patients also needed to adhere to the protocol-defined glucocorticosteroids taper regimen, which I believe is very important,” Bimba Hoyer, MD, commented in her presentation of congress highlights.
Sustained remission from weeks 12 to 52 was attained by significantly more participants in the upadacitinib 15 mg group than on placebo: 46.4% versus 29% (P=0.0019).1 Furthermore, participants on 15 mg of upadacitinib were significantly less likely to encounter a GCA flare up to 1 year with an HR of 0.57 (95% CI 0.40–0.83), and the group on 7.5 mg showed a trend in a similar direction with an HR 0.75 (95% CI 0.50–1.14). Significance for the higher doses of upadacitinib was also observed for complete remission and cumulative glucocorticosteroid exposure. The cumulative glucocorticosteroid exposure was 1,615 mg on the higher dose of upadacitinib compared with 2,882 mg on placebo.
“With regards to safety, I think there is nothing that was really surprising,” Dr. Hoyer pointed out. On the study drug, event rates per 100 patient-years for herpes zoster were 7.3 (15 mg) and 4.5 (7.5 mg) compared with 4.2 (placebo). The respective results for non-melanoma skin cancer and venous thromboembolism were 2.8 and 1.1 versus 2.1 and 5.6 and 4.5 versus 4.2.
“Overall, upadacitinib 15 mg provided a favorable benefit-risk profile and represents a potential new oral targeted therapy for patients with GCA,” Dr. Blockmans concluded.
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