DAPIROLIZUMAB PEGOL DEMONSTRATED IMPROVEMENT IN QUALITY OF LIFE OF PATIENTS WITH SYSTEMIC LUPUS ERYTHEMATOSUS: LUPUSQOL RESULTS FROM A PHASE 3 TRIAL

O011 / #377 Topic: AS19 - Patient-Reported Outcome Measures ABSTRACT CONCURRENT SESSION 01: FINDINGS FROM LUPUS CLINICAL TRIALS 22-05-2025 1:40 PM - 2:40 PM Background/Purpose Systemic lupus erythematosus (SLE) imposes significant disease burden and diminishes health-related quality of life (HRQOL); improvement of HRQOL is therefore a key treatment goal in SLE.[1,2] Dapirolizumab pegol (DZP) is a novel, polyethylene glycol (PEG)-conjugated antigen-binding (Fab’) fragment, lacking an Fc domain, that inhibits CD40L signaling. In the phase 3 PHOENYCS GO trial ( NCT04294667 ) in patients with SLE, DZP improved disease activity measured by clinician-reported outcomes at Week 48 vs placebo (PBO), and was generally well tolerated.[3] Here, we report the impact of DZP on HRQOL as measured by LupusQoL completed by patients in the PHOENYCS GO trial. Methods PHOENYCS GO was a 48-week, randomized, double-blind, PBO-controlled trial. Patients aged ≥ 16 years with moderate-to-severe, active SLE characterized by persistently active or frequently flaring/relapsing-remitting disease activity despite stable standard of care (SOC) medication (antimalarials, corticosteroids, and/or immunosuppressants) were included. Patients were randomized 2:1 to intravenous DZP 24 mg/kg plus SOC medication (DZP+SOC) or PBO+SOC every 4 weeks. HRQOL outcomes were measured using LupusQoL, a patient-reported outcome based on responses on a 5-point Likert scale to 34 items across 8 HRQOL domains.[1] Each domain score ranges from 0 to 100; higher scores indicate better HRQOL. The least square (LS) mean change from baseline in LupusQoL domain scores at Weeks 12, 24, 36, and 48 are reported. The LS mean, difference for DZP+SOC vs PBO+SOC, and 95% CIs were computed using a mixed model for repeated measurements (MMRM). Analyses were performed on the full analysis set. Results Overall, 97.6% (203/208) of patients receiving DZP+SOC and 95.3% (102/107) of patients receiving PBO+SOC had LupusQoL responses available at any visit. Baseline LupusQoL scores were comparable between the treatment groups (Table). Patients receiving DZP+SOC demonstrated consistently greater improvements from baseline over time in LupusQoL scores across all domains compared with PBO+SOC (Figure). Patients receiving DZP+SOC reported greater improvements in the ‘Fatigue’ and ‘Burden to others’ domains at all assessed visits compared with those receiving PBO+SOC, as of Week 12 (all p < 0.05; nominal). Additionally, greater improvements were reported for patients receiving DZP+SOC compared with PBO+SOC in the ‘Physical health’ and ‘Planning’ domains at Weeks 24, 36, and 48, in the ‘Pain’ and ‘Emotional health’ domains at Weeks 36 and 48, in the ‘Intimate relationships’ domain at Weeks 24 and 36, and in the ‘Body image’ domain at Week 48 (each p < 0.05; nominal). Table. Baseline LupusQoL domain scores Figure. LS mean change from baseline in LupusQoL domain scores by visit (MMRM) Conclusions Improvements in HRQOL were greater in patients treated with DZP+SOC vs PBO+SOC across all LupusQoL domains, starting at the earliest timepoint (Week 12) for some domains. These data, along with the previously reported significant improvements in overall disease activity,[3] support the potential of DZP as a valuable treatment option in SLE to improve HRQOL. References: [1.] McElhone K. Arthritis Care Res 2007;57:972-9. [2.] Fanouriakis A. Ann Rheum Dis 2019;78:736-45. [3.] Clowse M. Arthritis Rheumatol 2024;76 (suppl 9). Acknowledgments: This study was funded by UCB and Biogen. Medical writing support provided by Costello Medical and funded by UCB and Biogen.

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