GlobeNewswire·Nov 9, 2026, 1:00 AM ET

ACR 2026: Dapirolizumab Pegol Associated with Greater Treatment Response Rates Versus Placebo in SLE Using Novel Treatment Response Measure

UCB & Biogen presented post-hoc analyses of the Phase 3 PHOENYCS GO trial for dapirolizumab pegol (DZP) at ACR Convergence 2026.
Application of the novel TRM-SLE measure showed DZP plus standard of care (SOC) yielded higher response rates in at least half (TRM-SLE-50: 61.2% vs 43.2%) or all (TRM-SLE-100: 52.5% vs 36.8%) of active organ domains through Week 48 versus placebo plus SOC.
TRM-SLE is a patient-centric clinical outcome assessment developed by a global taskforce to evaluate meaningful improvements primarily in joint & skin domains.
Post-hoc data demonstrated greater rates of sustained low disease activity & remission with DZP plus SOC across Weeks 40, 44, & 48 compared to placebo plus SOC.
Specific sustained outcomes for DZP plus SOC included LLDAS (24.0% vs 10.3%), LLDAS-5 (19.2% vs 5.6%), & DORIS remission (11.5% vs 4.7%).
The PHOENYCS GO study previously reported DZP plus SOC met its primary endpoint of BICLA response at Week 48 (50% vs 35%) & showed favorable SRI-4 response (60% vs 41%).
DZP demonstrated a generally favorable safety profile consistent with prior studies, with lower rates of serious treatment-emergent adverse events & low discontinuation rates.
DZP is an investigational Fc-free PEG-conjugated Fab' fragment that inhibits CD40L signaling to reduce B-cell activation & autoantibody production.
The TRM-SLE analysis was conducted as a post-hoc assessment & not as a pre-specified regulatory endpoint, requiring further validation.