What’s Next for Dapirolizumab Pegol Following Lupus Phase 3 Trial, With Ed Vital, MD

Pivotal data from the phase 3 PHOENYCS GO trial showed dapirolizumab pegol (DZP) significantly stabilized disease activity and improved remission in patients with systemic lupus erythematosus by 48 weeks.1

Investigator Ed Vital, MD, a translational medicine expert at the University of Leeds, presented this data on Sunday, October 26 at ACR Convergence 2025 in Chicago. HCPLive sat with Vital during the meeting to discuss the significance of these findings, how DZP may impact lupus care, and what is next for DZP in the future.

“The really big next step is the second phase 3 trial,” Vital said. “Second [trial] is in progress now, which has a very similar design.”

Aside from the second phase 3 trial, investigators plan to assess patient-reported outcomes with DZP.

“Those can be quite difficult to demonstrate in lupus trials,” he said. “We think these drugs don't just improve physician assessments, but also make people feel better, but that that can be quite hard to show in trials…some of the early analyses of these trials, not all of it published yet, does seem to report quite good outcomes in things like patients’ report of how their fatigue improved. There'll be [a lot] to chew over with the data from these trials over the next few years.”

In this current phase 3 study, a 48-week, randomized, double-blind, placebo-controlled design, Vital and colleagues evaluated DZP in patients aged ≥ 16 years with moderate-to-severe SLE on stable standard-of-care, either antimalarials, glucocorticoids, or immunosuppressants. Participants were randomized 2:1 to receive DZP plus standard-of-care or placebo plus standard-of-care every 4 weeks.

The primary endpoint showed a greater rate of BILAG-based Composite Lupus Assessment (BICLA) response with DZP versus placebo. The study also evaluated remission using the DORIS criteria and low disease activity through the Lupus Low Disease Activity State (LLDAS), with encouraging results: 40.9% of patients on DZP achieved LLDAS at week 48 versus 19.6% with placebo (P < .0001), and 19.2% reached DORIS-defined remission versus 8.4% with placebo (P = .0056). Additionally, patients on DZP spent more time in LLDAS (2.9 vs 1.8 visits; P = .0016) and more often maintained LLDAS across visits through week 48.

At the meeting, Vital also presented a post-hoc analysis from a phase 2 study, which showed that lanalumab achieved lupus sustained low activity state and remission in patients with systemic lupus erythematosus.2

“In the world of lupus, we've spent a long time with only one biologic,” Vital said. “Now we have two biologics, one other novel therapy, but there are lots of phase 3 trials in progress, and in the next 2 to 3 years, we could be in a situation where there are a lot of drugs produced, which, in some ways, will make things a little bit more complicated. All these drugs work in different ways, so rheumatologists are going to have to think, ‘Well, do I want to target B cells, which I want to target interferon, which I want to target CD40, or do I want to target TLS-7, and so on. I predict there'll be intense interest in trying to work out which mechanism is right for which patient, which is difficult, but it's a good problem to have.”

Vital has no relevant reported disclosures.

References

1. Morand E, Carter L, Dall'Era M, Petri M, Vital E, Jimenez T, Gaiha-Rohrbach J, Lauwerys B, Nelde A, Stach C, van Vollenhoven R. Achievement of Low Disease Activity and Remission in Patients with Systemic Lupus Erythematosus Treated with Dapirolizumab Pegol: 48-Week Results from a Phase 3 Trial [abstract]. Arthritis Rheumatol. 2025; 77 (suppl 9). https://acrabstracts.org/abstract/achievement-of-low-disease-activity-and-remission-in-patients-with-systemic-lupus-erythematosus-treated-with-dapirolizumab-pegol-48-week-results-from-a-phase-3-trial/. Accessed November 4, 2025.

2. Morand E, Gaillez C, Oliver S, Ghanshani S, Pozzobon M, Bao W, Vital E. Achieving Sustained Lupus Low Disease Activity State and Remission With Ianalumab (VAY736) in Patients with Systemic Lupus Erythematosus: A post hoc Analysis From a Phase II Study [abstract]. Arthritis Rheumatol. 2025; 77 (suppl 9). https://acrabstracts.org/abstract/achieving-sustained-lupus-low-disease-activity-state-and-remission-with-ianalumab-vay736-in-patients-with-systemic-lupus-erythematosus-a-post-hoc-analysis-from-a-phase-ii-study/. Accessed November 4, 2025.