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PHOENYCS GO phase III trial: Dapirolizumab pegol + SoC vs placebo + SoC in SLE
Dapirolizumab pegol (DZP), a polyethylene glycol-conjugated antigen-binding fragment, is a novel CD40L inhibitor with broad immunomodulatory effects on SLE. Results from the phase III PHOENYCS GO trial (NCT04294667) evaluating the efficacy and safety of DZP in patients with moderate-to-severe SLE (N = 315) were presented by Clowse at a recent rheumatology congress.1 Patients were randomized 2:1 to receive 24 mg/kg DZP + SOC (n = 208) or PBO + SOC (n = 107) every 4 weeks.1 The primary endpoint was BICLA response at Week 48. Key secondary endpoints included SRI-4 response and prevention of severe BILAG flares at Week 48.1 |
Key learnings |
| At Week 48, a BICLA response was achieved in 49.5% of patients with DZP + SOC vs 34.6% with PBO + SOC (p = 0.0110; difference 14.6%). SRI-4 responses were achieved in 60.1% and 41.1% of patients, respectively (p = 0.0014). |
| The DZP + SOC group experienced lower rates of severe BILAG flares than the PBO + SOC group (11.6% vs 23.4%; p = 0.0257). |
| A higher proportion of patients reduced their corticosteroid dose to ≤7.5 mg/day with DZP + SOC vs PBO + SOC (72.4% vs 52.9%; p = 0.0404). |
| TEAEs occurred in 82.6% of patients receiving DZP + SOC vs 75.0% of patients receiving PBO + SOC, whilst serious TEAEs were reported in 9.9% vs 14.8% of patients. Opportunistic infections were higher with DZP + SOC vs PBO + SOC (2.8% vs 0.9%). |
| Findings from the PHOENYCS GO trial suggest that DZP + SOC was well tolerated and resulted in improved disease activity, BICLA response, and reduction in corticosteroid dose vs PCO + SOC in patients with SLE. |
Abbreviations: BICLA, British Isles Lupus Assessment Group-based Composite Lupus Assessment; BILAG, British Isles Lupus Assessment Group; DZP, dapirolizumab pegol; PBO, placebo; SLE, systemic lupus erythematosus; SRI-4, Systemic Lupus Erythematosus Disease Activity Index response at ≥4 points; SOC, standard of care; TEAE, treatment-emergent adverse event.
References
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