AbbVie has revealed positive top-line outcomes from the first period of the Phase III SELECT-GCA study of upadacitinib (RINVOQ; 15mg, once daily) in combination with a steroid taper regimen in adults with giant cell arteritis (GCA).

The multicentre, randomised, double-blind, placebo-controlled trial enrolled 428 patients.

Divided into two periods, the study is designed to assess the safety and efficacy of upadacitinib plus a 26-week steroid taper regimen.

The initial period focused on the efficacy of upadacitinib paired with a 26-week corticosteroid taper regimen versus placebo coupled with a 52-week corticosteroid taper regimen. This period also evaluated the drug’s safety and tolerability.

The subsequent period will investigate the safety and efficacy of continuing or discontinuing upadacitinib in maintaining remission for those who had sustained remission during the first period.

According to the findings from the initial period, the trial reached its primary endpoint, with sustained remission from week 12 to week 52.

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Notably, 46% of the subjects treated with upadacitinib 15mg plus 26-week steroid taper regimen attained sustained remission, surpassing the 29% remission rate in the placebo group with a 52-week taper regimen.

The trial also successfully met key secondary endpoints.

A greater proportion of patients in the upadacitinib arm achieved sustained complete remission from weeks 12 to 52 compared to the placebo group.

Furthermore, fewer patients experienced disease flares through week 52 in the upadacitinib group compared to the placebo group.

However, the study results indicated that a lower dose of upadacitinib, 7.5mg, did not meet the primary or secondary endpoints.

The safety profile of upadacitinib 15mg was found to be in line with those reported in approved indications during the 52-week trial.

The treatment was also well tolerated, without any new safety signals detected.

AbbVie immunology clinical development vice-president and global head Kori Wallace said: “Many people living with GCA continue to suffer from the potentially debilitating symptoms of this disease, with limited treatment options available to them.

“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.”

In January, the company reported positive data from its Phase II clinical trial of the investigational drug lutikizumab (ABT-981).