Upadacitinib for Giant-Cell Arteritis - A Phase 3 Trial Save

The NEJM has published a randomized controlled trial in giant-cell arteritis (GCA) patients, demonstrating significant efficacy and safety of upadacitinib (UPA), given as 15 mg daily, as compared to placebo. 

 

A total of 209 GCA patients (70% had had new onset GCA) were randomized in a 2:1:1 ratio, to receive upadacitinib at a dose of 15 mg or 7.5 mg once daily in combination with a prespecified 26-week glucocorticoid (GC) taper or placebo.  The primary end point was sustained remission at week 52, defined by the absence of signs or symptoms of giant-cell arteritis from week 12 through week 52 and adherence to the protocol-specified glucocorticoid taper.

 

Upadacitinib at a dose of 15 mg showed superiority over placebo with 46% achieving the primary end point (vs. 29% placebo response; P=0.002).  

 

15 mg UPA was superior to placebo in all key secondary end points, including sustained complete remission, time to a disease flare, cumulative glucocorticoid exposure, and patient-reported outcomes. 

 

Upadacitinib at 7.5 mg daily was not superior to placebo by primary end point (41%)

 

Adverse events through 52 weeks were similar between groups and there were no major adverse cardiovascular events occurred in the UPA groups.