Nearly half of patients with giant cell arteritis achieve remission with upadacitinib
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Key takeaways:
- Upadacitinib bested placebo for achieving remission at 52 weeks in GCA, a new indication for the drug.
- The safety profile was consistent with that seen in previously approved indications.
Nearly half of patients with giant cell arteritis who received upadacitinib while tapering steroids achieved remission from weeks 12 through 52 in a phase 3 trial, according to a press release from AbbVie.
“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 date commonly used with steroids,” lead investigator Daniel Blockmans, MD, PhD, of the department of general internal medicine at University Hospitals Gasthuisberg, in Belgium, said in the release.
Topline results from the multicenter, randomized, double-blind, placebo-controlled SELECT-GCA trial demonstrated that 46% of patients treated with 15 mg of upadacitinib (Rinvoq, AbbVie) once daily — alongside a 26-week steroid taper regimen — achieved sustained remission, compared with 29% of those treated with placebo and a 52-week steroid taper regimen (P = .0019).
Upadacitinib is currently used to treat moderate to severe rheumatoid arthritis, active psoriatic arthritis and autoimmune conditions. In SELECT-GCA, the drug’s safety was “generally consistent” with that observed in the approved indications, with no new safety signals, according to the release.
The study also met key secondary endpoints, including a lower percentage of patients in the treatment group experiencing at least one disease flare vs. placebo (34% vs. 56%; P = .0014).
“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 and global head of immunology clinical development at AbbVie, said in the release. “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.”
According to AbbVie, the first period of the SELECT-GCA trial, reported in these topline results, will be followed by another period to evaluate the safety and efficacy of continuing vs. withdrawing upadacitinib in remission maintenance.
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