Commentary
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Clowse discussed findings from the phase 3 PHOENYCS GO trial presented at the 2024 ACR Convergence.
The phase 3 PHOENYCS GO trial (NCT04294667) has met its primary endpoint, achieving BICLA response with Dapirolizumab Pegol (DZP) in systemic lupus erythematosus (SLE) at week 48 compared with placebo.
These data were presented at the American College of Rheumatology (ACR) Convergence 2024, held November 14-19 in Washington, DC by Megan Clowse, MD, MPH, Associate Professor of Medicine, Associate Professor in Obstetrics and Gynecology, and Associate Professor in Population Health Sciences, and Chief of the Division of Rheumatology and Immunology, Duke University School of Medicine.
Around half (49.5%; n = 103) of the DZP group and 34.6% (n = 37) of the placebo group achieving BICLA response at week (P = .0110; difference, 14.6% [95% CI, 3.3-25.8]). Similarly, 60.1% (n = 125) of the DZP group and 41.1% (n = 44) of the placebo group achieved SRI-4 response at week 48 (nominal P = .0014; difference, 18.8% [95% CI, 7.3-30.3]).
Importantly, 72.4% (n = 76) of the DZP group that was receiving over 7.5 mg/day of corticosteroids prednisone equivalent at baseline and 52.9% (n = 27) of these patients in the placebo group reduced their dose to at most 7.5 mg/day at week 48 (nominal P = .0404; difference, 17.1%).
“People were able to taper steroids and their lupus symptoms got significantly better through the study. We really addressed both of those needs, that people need to be on less steroids and feel better, and we managed to do that really nicely,” Clowse told HCPLive®.
Clowse's relevant disclosures include GlaxoSmithKline and UCB.