Glucocorticoid-sparing disease control with dapirolizumab pegol in SLE

Results from 48 weeks of the randomized, double-blind, placebo-controlled phase III PHOENYCS GO trial (NCT04294667) evaluating dapirolizumab pegol + standard of care (SoC) in 321 patients aged ≥16 years with moderate-to-severe active systemic lupus erythematosus (SLE) were presented by Eric Morand at the European Alliance of Associations for Rheumatology (EULAR) 2026 Congress, June 3–6, 2026, London, UK. Patients were stratified by daily glucocorticoid dose into those receiving >7.5 mg/day and those receiving ≤7.5 mg/day. The aim was to analyze glucocorticoid dose reduction while maintaining disease control through 48 weeks.

Key data: By Week 24, a greater proportion of patients in the >7.5 mg group receiving dapirolizumab pegol + SoC vs placebo + SoC reduced their glucocorticoid dose to ≤7.5 mg/day and maintained this reduction through Week 48 (68.6% vs 43.1%; 95% confidence interval [CI], 6.7–39.4; p = 0.0056). Furthermore, patients in the >7.5 mg group receiving dapirolizumab pegol + SoC vs placebo + SoC achieved higher rates of British Isles Lupus Assessment Group (BILAG)-based Composite Lupus Assessment (BICLA; 44.8% vs 25.5%; p = 0.0121) and SLE Responder Index-4 (SRI-4; 51.4% vs 33.3%; p = 0.0343) responses alongside stable glucocorticoid reduction at Week 48. The proportion of patients who remained moderate/severe BILAG-2004 flare-free (62.9% vs 40.6%; p = 0.0291) and who achieved BICLA while remaining moderate/severe BILAG-2004 flare-free (43.3% vs 25.3%; p = 0.0224) at Week 48 was greater in the dapirolizumab pegol vs placebo group. 

Key learning: Dapirolizumab pegol + SoC demonstrated a greater and durable glucocorticoid-sparing effect while maintaining disease control vs placebo, potentially enabling patients to achieve guideline-recommended treatment targets. A confirmatory phase III trial (PHOENYCS-FLY; NCT06617325) is currently underway.