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Fatigue, Pain, Daily Function: DZP’s Patient-Centered Impact in SLE, with Rosalind Ramsey-Goldman, MD
Ramsey-Goldman emphasized the importance of QoL in lupus, looking beyond disease scores.
Dapirolizumab pegol (DZP), a novel, Fc-free anti-CD40L therapy, continues to demonstrate meaningful patient-centered benefits in systemic lupus erythematosus (SLE).
These findings are from a new analysis from the phase 3 PHOENYCS GO trial presented at the American College of Rheumatology (ACR) Convergence 2025, held October 24–29 in Chicago, Illinois, by Rosalind Ramsey-Goldman, MD, Gallagher Research Professor of Rheumatology, Feinberg School of Medicine, Northwestern University.
The new data demonstrate that not only did DZP plus standard of care (SOC) meet its primary efficacy endpoint, achieving significantly higher rates of BILAG-based Composite Lupus Assessment (BICLA) response vs placebo +SOC at Week 48, but also produced broad and consistent improvements in health-related quality of life (HRQoL), as assessed by the LupusQoL instrument.
HCPLive spoke with Rosalind Ramsey-Goldman, MD, during the meeting to learn more about the importance of these findings—particularly as HRQoL gains increasingly shape modern lupus drug evaluation.
In PHOENYCS GO, 203 patients receiving DZP+SOC and 102 receiving placebo+SOC provided LupusQoL data. Baseline scores were comparable across groups. By Week 12, patients treated with DZP were already demonstrating superior improvements across multiple domains, gains that deepened through Week 48.
Across 8 LupusQoL domains, DZP+SOC achieved significantly greater LS mean improvements versus placebo+SOC, including:
- Fatigue: LS mean difference 10.5 (95% CI, 5.4-15.6); nominal P <.0001
- Pain: LS mean difference 6.4 (95% CI, 1.1-11.7); nominal P = .0174
- Physical health: LS mean difference 7.6 (95% CI, 2.9-12.3); nominal P = .0016
- Emotional health: LS mean difference 7.1 (95% CI, 2.7-11.4); nominal P = .0014
- Body image: LS mean difference 6.4 (95% CI, 0.6-12.2); nominal P = .0301
- Intimate relationships: LS mean difference 6.3 (95% CI, –0.6 to 13.2); nominal P = .0715
- Planning: LS mean difference 8.2 (95% CI, 2.3-14.1); nominal P = .0069
- Burden to others: LS mean difference 10.9 (95% CI, 4.8-17.1); nominal P = .0005
Ramsey-Goldman emphasized that these outcomes are particularly meaningful because they capture aspects of disease not always reflected in traditional clinical endpoints. Fatigue, pain interference, emotional burden, and functional limitations often remain debilitating even when laboratory markers improve. The inclusion of patient-reported outcomes in trials like PHOENYCS GO ensures that treatment benefits extend beyond physician-based assessments.
Importantly, the HRQoL findings reinforce the clinical value of CD40L inhibition in SLE and support DZP as a therapy capable of improving both measurable disease activity and daily lived experience.
"In more recent trials, they've been adding these patient reported outcomes as additional [data] to see how the patient responds to the drug, even if it's not the primary outcome... it's still important clinical information," Ramsey-Goldman said.
Ramsey-Goldman's reported disclosures include Ampel Solutions, AstraZeneca, Biogen, Cabaletta, Duke, Exagen Diagnostics, Merck, and SUNY Syracuse.
