Upadacitinib shows ‘broad efficacy’ across patient subgroups in giant cell arteritis
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WASHINGTON — Upadacitinib 15 mg is superior to placebo for achieving sustained remission in giant cell arteritis across patient subgroups based on age, sex and glucocorticoid experience, according to data presented at ACR Convergence 2024.
“There is interest in how this drug works in subgroups of patients,” Peter Merkel, MD, of the division of rheumatology, in the department of medicine, at the University of Pennsylvania, told attendees.
According to Merkel, the prior phase 3 SELECT-GCA trial showed that upadacitinib (Rinvoq, Abbvie) 15 mg has a favorable benefit-risk profile in patients with GCA. That trial overall included 209 patients in the upadacitinib 15 mg arm, 107 patients in the upadacitinib 7.5 mg arm, and 112 patients in the placebo arm.
To examine upadacitinib’s efficacy across various patient subgroups based on baseline characteristics, Merkel and colleagues analyzed data specifically from the 15 mg and placebo arms. Eligible participants were aged 50 years and older with new-onset or relapsing GCA, with active disease within 8 weeks of baseline, who had received 40 mg or more of prednisone prior to baseline and were taking 20 mg or more of prednisone at baseline. The mean age of the cohort was 71 years, with 70% demonstrating new-onset disease and 30% with relapsing disease. The study included patients from 100 sites in 24 countries.
Sustained remission at 52 weeks served as the primary endpoint. This involved an absence of signs and symptoms of GCA between weeks 12 and 52.
“There was a fairly high bar for sustained remission,” Merkel said.
The researchers also assessed sustained complete remission between weeks 12 and 52. This endpoint involved the sustained remission endpoint plus normalization of acute phase reactants, according to Merkel.
“There was a higher bar for sustained complete remission,” he said.
According to the researchers, the 15-mg formulation of upadacitinib bested placebo in achieving the primary endpoint, 46% vs. 29% (P = .0019). A similar outcome was reported for the main secondary endpoint, 37% vs. 16% (P < .0001).
Meanwhile, the general trend for the subgroup analysis was that upadacitinib 15 mg performed comparably across groups.
“For sex, there was no difference, no signal,” Merkel said. “One sex was not more likely to respond than another.”
This trend held true across age and smoking status cohorts.
“There was no difference in the response rate in the two groups whether they are new onset or had relapsing disease,” Merkel added. “I think that is interesting.”
Similar trends were observed when patients were stratified based on prior interleukin-6 use and glucocorticoid use.
“How much [of a glucocorticoid dose] they started with did not make a difference,” Merkel said.
Importantly, Merkel stressed that upadacitinib showed some efficacy in all of these treatment subgroups.
“Across nearly all evaluated subgroups of SELECT-GCA, treatment with upadacitinib 15 mg resulted in generally similar rates of sustained remission and sustained complete remission as observed for the overall trial population,” he said. “These results further support the broad efficacy of upadacitinib 15 mg across the population of patients with GCA.”
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Merkel P. Abstract #1695. Presented at: ACR Convergence 2024; Nov. 14-19, 2024; Washington, D.C.
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