In the primary analysis of the SELECT-GCA trial, upadacitinib 15 mg was superior to placebo in sustaining remission in patients with giant cell arteritis (GCA). The JAK-STAT inhibitor was combined with a 26-week taper regimen of glucocorticoids, which was also more effective than a placebo with a 52-week glucocorticoid taper.
Upadacitinib is an oral inhibitor of the JAK-dependent cytokines IL-6 and IFN-γ. Prof. Peter Merkel, from the University of Pennsylvania, and colleagues, assessed its efficacy and safety, in combination with a glucocorticoid taper regimen, for the treatment of GCA in the phase-3 trial SELECT-GCA (NCT03725202)1. Prof. Merkel presented results from the first of two blinded 52-week study periods. Inclusion criteria were 50 years or older, new-onset or relapsing GCA, and CG use.
The 428 participants had a mean age of 71 years, 27% were men, and 30% had relapsing GCA. The patients received upadacitinib 7.5 mg (n=107), upadacitinib 15 mg (n=209), or placebo (n=112) once daily. This treatment was combined with glucocorticoid taper regimen of 26 weeks in the upadacitinib group and 52 weeks in the placebo group. The primary endpoint was sustained remission, defined as the absence of signs or symptoms of GCA from week 12 to 52 and adherence to the glucocorticoid taper regimen.
A significantly higher rate of participants in the upadacitinib 15 mg group achieved sustained remission versus placebo at week 52: 46.4% and 29.0%, respectively (P=0.0019). With upadacitinib 15 mg, 9 of 11 multiplicity-controlled secondary endpoints were also met. Cumulative median glucocorticoid exposure was significantly lower with upadacitinib 15 mg compared with placebo: 1,615 versus 2,882 mg (P<0.0001). This was unsurprising, Prof. Merkel said, as the placebo group had a longer tapering period. It still confirms that the protocol was followed and that this strategy allows glucocorticoid reduction. There were no new safety signals. Rates of treatment-emergent AEs were similar across all three groups, including serious infections and major cardiac events.
Medical writing support was provided by Michiel Tent
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