dapirolizumab pegol (CDP7657) / Biogen, UCB, Nektar Therapeutics - LARVOL DELTA

Glucocorticoid-Sparing Maintenance of Disease Control in Patients with Systemic Lupus Erythematosus: 48-Week Results from a Phase 3 Trial of Dapirolizumab Pegol (ACR Convergence 2026) - No abstract available

Clinical • P3 data • Immunology • Inflammatory Arthritis • Lupus • Systemic Lupus Erythematosus

Improvement in Laboratory Markers of Disease Activity with Dapirolizumab Pegol Treatment in Patients with Systemic Lupus Erythematosus: Updated Analyses from a 48-Week Phase 3 Trial (ACR Convergence 2026) - No abstract available

Clinical • P3 data • Immunology • Inflammatory Arthritis • Lupus • Systemic Lupus Erythematosus

Dapirolizumab Pegol Treatment Resulted in Sustained Attainment of Low Disease Activity and Remission in Patients with Systemic Lupus Erythematosus: 48-Week Results from a Phase 3 Trial (ACR Convergence 2026) - No abstract available

Clinical • P3 data • Immunology • Inflammatory Arthritis • Lupus • Systemic Lupus Erythematosus

Treatment Response Measure for Systemic Lupus Erythematosus (TRM-SLE): Application to a Phase 3 Trial of Dapirolizumab Pegol (ACR Convergence 2026) - No abstract available

P3 data • Immunology • Inflammatory Arthritis • Lupus • Systemic Lupus Erythematosus

Re-engineering CD154 blockade for transplantation: Fc-free design to separate thrombotic risk from therapeutic function. (PubMed, Clin Transplant Res) - "Size-based carriers recover only the second: conjugation of polyethylene glycol (PEG) to an anti-CD154 Fab' extends its half-life from hours to weeks, as in dapirolizumab pegol, but leaves FcRn recycling unaddressed, while uncertainties remain regarding long-term PEG exposure. Albumin recovers both through FcRn-dependent recycling and its own molecular size, without engaging Fcγ receptors. Dazodalibep, an Fc-free albumin-fusion CD154 antagonist, was administered with belatacept to kidney transplant recipients in a single-arm phase 2a trial without thrombotic events, but the prespecified composite efficacy endpoint was not met."

Journal • Review • Cardiovascular • Transplant Rejection • Transplantation • CD40 • CD40LG

In SLE, adding dapirolizumab pegol vs. placebo to usual care improved disease activity at 48 wk. (PubMed, Ann Intern Med) - "GIM/FP/GP: [Formula: see text] Rheumatology: [Formula: see text]."

Journal • Inflammatory Arthritis • Rheumatology

Dapirolizumab pegol improves SLE disease activity in phase III trial. (PubMed, Nat Rev Rheumatol) - No abstract available

Journal • P3 data • Inflammatory Arthritis

MEASURING FATIGUE IN SYSTEMIC LUPUS ERYTHEMATOSUS: MEASUREMENT PROPERTIES OF THE FATIGUE-PRO TOTAL SCORE USING DATA FROM A PHASE 3 TRIAL OF DAPIROLIZUMAB PEGOL (EULAR 2026) - P2, P3 | "Conclusions These analyses of the FATIGUE-PRO using data from the PHOENYCS GO trial of DZP, together with previous qualitative research,2,3 support use of both a Total Score calculated from the 31 items to summarise the overall fatigue, and the individual domain scores to provide a more granular description of the patient experience. These results support the FATIGUE-PRO as a well-defined, reliable and sensitive measure of fatigue in SLE."

P3 data • Fatigue • Immunology • Inflammatory Arthritis • Lupus • Systemic Lupus Erythematosus

DAPIROLIZUMAB PEGOL AND FLARE REDUCTION IN PATIENTS WITH SYSTEMIC LUPUS ERYTHEMATOSUS IN A 48-WEEK PHASE 3 TRIAL: AN UPDATED POST HOC ANALYSIS OF ALTERNATIVE DEFINITIONS OF FLARES THAT REFLECT CLINICAL PRACTICE (EULAR 2026) - P3 | "For patients with baseline dose >7.5 mg/day prednisone equivalent, investigators were required to initiate tapering of glucocorticoid dose no later than Week 8, with the aim to reach ≤7.5 mg/day by Week 24, per EULAR 2019 treatment guidelines at the time of the study.2 Severe BILAG-2004 flares were defined using a pre-specified definition of ≥1 BILAG-2004 Grade A due to a new/worse individual item(s) at a single visit. Patients receiving DZP+SOC versus PBO+SOC had fewer BILAG-2004 flares by all definitions and more frequently tapered glucocorticoid dose while remaining flare-free. These results support the re-evaluation of how flares are captured in clinical trials, and that the alternative definitions of flares may better reflect clinical practice."

Clinical • P3 data • Retrospective data • Immunology • Infectious Disease • Inflammatory Arthritis • Lupus • Systemic Lupus Erythematosus • CD40LG

DAPIROLIZUMAB PEGOL TREATMENT AND IMPROVEMENT IN LABORATORY MARKERS OF DISEASE ACTIVITY IN PATIENTS WITH SYSTEMIC LUPUS ERYTHEMATOSUS: 48-WEEK RESULTS FROM A PHASE 3 TRIAL (EULAR 2026) - P3 | "For patients with baseline dose >7.5 mg/day prednisone equivalent, investigators were required to initiate tapering of glucocorticoid dose no later than Week 8, with the aim to reach ≤7.5 mg/day by Week 24, per EULAR 2019 treatment guidelines at the time of the study.6 Anti-dsDNA antibody levels were measured using the Phadia EliATM assay. Conclusions Normalisation of levels of anti-dsDNA antibodies and complement proteins C3 and C4 was more frequent in patients with SLE receiving DZP+SOC versus PBO+SOC. These findings build on previously reported data and suggest that DZP modulates important immune parameters in SLE, which could help prevent organ damage through reduced deposition of immune complexes and complement activation."

Clinical • P3 data • Immunology • Infectious Disease • Inflammatory Arthritis • Lupus • Systemic Lupus Erythematosus • CD40LG

GLUCOCORTICOID-SPARING MAINTENANCE OF DISEASE CONTROL IN PATIENTS WITH SYSTEMIC LUPUS ERYTHEMATOSUS: 48-WEEK RESULTS FROM A PHASE 3 TRIAL OF DAPIROLIZUMAB PEGOL (EULAR 2026) - P3 | "4 As previously reported, a higher proportion of patients with glucocorticoid dose >7.5 mg/day prednisone equivalent at baseline receiving DZP+SOC versus PBO+SOC reduced their dose to ≤7.5 mg/day prednisone equivalent at Week 48 (72.4% versus 52.9%; nominal p=0.0404).4 However, tapering glucocorticoids may negatively impact disease activity, therefore evaluation of the glucocorticoid-sparing effect of DZP while maintaining disease control is of clinical interest. Further, higher proportions of patients receiving DZP+SOC versus PBO+SOC achieved this sustained reduction while also achieving BICLA response at Week 48 (44.8% [47/105] versus 25.5% [13/51]); achieving SRI-4 response at Week 48 (51.4% [54/105] versus 33.3% [17/51]); or while remaining moderate/severe BILAG-2004 flare-free through Week 48 (62.9% versus 40.6%; Figure 1). Conclusions Treatment with DZP+SOC was associated with higher proportions of patients simultaneously achieving glucocorticoid tapering..."

Clinical • P3 data • Immunology • Infectious Disease • Inflammatory Arthritis • Lupus • Systemic Lupus Erythematosus • CD40LG

UCB and Biogen Announce Publication in The Lancet of Positive Dapirolizumab Pegol (DZP) Phase 3 Study Results in Systemic Lupus Erythematosus (Yahoo Finance) - "In the Phase 3 study, DZP successfully met the primary endpoint: a significantly greater proportion of patients receiving DZP plus standard of care (SOC) achieved British Isles Lupus Assessment Group (BILAG)-based Composite Lupus Assessment (BICLA) response at Week 48 (50%; 103/208) compared to placebo plus SOC (35%; 37/107; p=0.011)...Because the first key secondary endpoint was not met (BICLA response at week 24), subsequent outcomes were not controlled for multiplicity. Results in favor of DZP plus SOC were observed across multiple outcomes, including severe BILAG flares, SRI-4, SLEDAI-2K, skin- and joint-related outcomes, and the serological markers anti-dsDNA antibodies and complement C3 and C4...Further data from the PHOENYCS GO study will be presented this week at the Annual European Congress of Rheumatology (EULAR)."

P3 data • Systemic Lupus Erythematosus

Targeting CD40 with dapirolizumab pegol: a new treatment for systemic lupus erythematosus. (PubMed, Lancet) - No abstract available

Journal • Immunology • Inflammatory Arthritis • Lupus • Systemic Lupus Erythematosus • CD40

Efficacy and safety of the CD40 ligand inhibitor dapirolizumab pegol in systemic lupus erythematosus (PHOENYCS GO): a randomised, double-blind, placebo-controlled, phase 3 trial. (PubMed, Lancet) - P3 | "Dapirolizumab pegol was associated with significant improvement in disease activity in patients with SLE. These findings support the further investigation of dapirolizumab pegol as a treatment option for SLE."

Journal • P3 data • Cardiovascular • Immunology • Infectious Disease • Inflammatory Arthritis • Lupus • Myocardial Infarction • Septic Shock • Systemic Lupus Erythematosus • CD40LG

PHOENYCS FLY: A Study to Evaluate the Efficacy and Safety of Dapirolizumab Pegol in Study Participants With Moderately to Severely Active Systemic Lupus Erythematosus (clinicaltrials.gov) - P3 | N=450 | Recruiting | Sponsor: UCB Biopharma SRL | N=112 ➔ 450

Enrollment change • Immunology • Inflammatory Arthritis • Lupus • Systemic Lupus Erythematosus

Dapirolizumab pegol: Data readout from P3 PHOENYCS FLY trial (NCT06617325) for moderately-to-severe SLE between 2028 and 2030 (Biogen) - Q1 2026 Results

P3 data • Lupus • Systemic Lupus Erythematosus

Dapirolizumab Pegol and Flare Reduction in Patients with SLE in a 48-Week Phase 3 Trial: An Updated Post Hoc Analysis of Alternative Definitions of Flares that Reflect Clinical Practice (LUPUS 2026) - P3 | "Investigators were required to taper glucocorticoid dose, starting by Week 8, for patients with baseline dose >7.5 mg/day prednisone equivalent. Patients receiving DZP+SOC versus PBO+SOC had fewer BILAG-2004 flares by all definitions, and more frequently tapered glucocorticoid dose while remaining flare-free. These results support the re-evaluation of how flares are captured in clinical trials; the alternative definitions may better reflect clinical practice."

Clinical • P3 data • Retrospective data • Immunology • Inflammatory Arthritis • CD40LG

Improvement of Fatigue, Musculoskeletal Pain, Morning Stiffness and Health-Related Quality of Life in Patients with SLE Treated with Dapirolizumab Pegol: 48-Week Results from a Phase 3 Trial (LUPUS 2026) - P3 | "Investigators were required to taper glucocorticoid dose, starting by Week 8, for patients with baseline dose >7.5 mg/day prednisone equivalent.Patient-reported outcomes were assessed using the following measures: Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue, FATIGUE-PRO (a novel SLE-specific measure covering three domains: Physical Fatigue, Mental and Cognitive Fatigue, and Susceptibility to Fatigue), pain and stiffness visual analogue scales of the Lupus Arthritis and Musculoskeletal Disease Activity (LAMDA) instrument, and LupusQoL.Results Baseline characteristics were comparable between groups (DZP+SOC: n=208; PBO+SOC: n=107); patients had substantial disease burden ( table 1). Patients receiving DZP+SOC demonstrated greater improvements to Week 48 in LupusQoL scores versus PBO+SOC (figure 1C).Abstarct PO:13:336 Figure 1LS mean change from baseline in fatigue, musculoskeletal pain, morning stiffness and LupusQoL scoresAbstarct PO:13:336..."

Clinical • HEOR • P3 data • Immunology • Inflammatory Arthritis • Lupus • CD40LG

Achievement of Low Disease Activity and Remission in Patients with SLE Treated with Dapirolizumab Pegol: Updated 48-Week Analyses from a Phase 3 Trial Including Lower Glucocorticoid Dose Criteria (LUPUS 2026) - P3 | "Investigators were required to taper glucocorticoid dose, starting by Week 8, for patients with baseline dose >7.5 mg/day prednisone equivalent.The pre-specified LLDAS definition required glucocorticoid dose =3 consecutive visits (nominal p=0.0208; figure 1C).Abstract PT4:04 Table 1Baseline demographics and disease characteristicsAbstract PT4:04 Figure 1Achievement of LLDAS, LLDAS-5 and remission outcomes through week 48 Conclusions DZP+SOC resulted in higher rates of achievement and time in LLDAS and remission versus PBO+SOC. This remained true with a more stringent definition of LLDAS (glucocorticoid dose <=5 mg/day), aligning with current treatment guidelines."

Clinical • P3 data • Immunology • Inflammatory Arthritis • Lupus • CD40LG

Dapirolizumab pegol: Data readout from P3 PHOENYCS FLY trial (NCT06617325) for moderately-to-severe SLE between 2028 and 2030 (Biogen) - Q3 2025 Results

P3 data • Lupus • Systemic Lupus Erythematosus

Dapirolizumab Pegol, a Novel CD40L Inhibitor, Showed No Adverse Outcomes in an In Vivo Non-Human Primate Reprotoxicity Study and Displayed Minimal to No Human Placental Transfer in an Ex Vivo Study (ACR Convergence 2025) - P3 | "DZP showed no adverse outcomes on pregnancy or infant development post-birth in NHPs. In the ex vivo human placental model, DZP transfer was below the level of detection. These data align with lack of active placental transfer via the neonatal Fc receptor, causing minimal to no DZP transfer from mother to fetus, and suggest DZP may not be anticipated to cross the placenta to significant levels."

Adverse events • Preclinical • Inflammatory Arthritis • CD40LG

Alternative Definitions of Moderate Flares That Simulate Clinical Practice in Systemic Lupus Erythematosus: Post Hoc Exploration of Moderate Flares in Patients Treated with Dapirolizumab Pegol in a 48-week Phase 3 Trial (ACR Convergence 2025) - P3 | "Pts treated with DZP+SOC had fewer BILAG 2004 moderate flares, by all definitions considered, vs those treated with PBO+SOC. When allowing for longer time intervals over consecutive visits to evaluate moderate flares with the alternative definitions, greater rates of BILAG 2004 moderate flares were observed, particularly for pts receiving PBO+SOC, and greater differentiation between DZP+SOC and PBO+SOC was also observed. These results confirm a need to re-evaluate how flares are captured in SLE clinical trials; the alternative definitions of flares explored may better simulate clinical practice than the native definition of BILAG 2004 moderate flares."

Clinical • P3 data • Retrospective data • Immunology • Inflammatory Arthritis • Lupus • Systemic Lupus Erythematosus • CD40LG

Dapirolizumab Pegol Demonstrated Improvement in Quality of Life of Patients with Systemic Lupus Erythematosus: LupusQoL Results from a Phase 3 Trial (ACR Convergence 2025) - P3 | "Improvements in HRQoL were greater in patients treated with DZP+SOC compared with PBO+SOC across all LupusQoL domains, starting at the earliest time point (Wk 12) for some domains. These data, along with the previously reported significant improvements in overall disease activity,5 support the potential of DZP as a valuable treatment option in SLE to improve HRQoL."

Clinical • HEOR • P3 data • Fatigue • Immunology • Infectious Disease • Inflammatory Arthritis • Lupus • Systemic Lupus Erythematosus • CD40LG

Improvement of Fatigue, Musculoskeletal Pain, and Morning Stiffness in Patients with Systemic Lupus Erythematosus Treated with Dapirolizumab Pegol: 48-Week Results from a Phase 3 Trial (ACR Convergence 2025) - P3 | "Improvements in fatigue, musculoskeletal pain, and morning stiffness were greater in pts treated with DZP+SOC vs PBO+SOC. Alongside the previously reported improvements in clinical measures of SLE disease activity,3 these data suggest that DZP improves core pt-reported symptoms in SLE."

Clinical • P3 data • Fatigue • Immunology • Infectious Disease • Inflammatory Arthritis • Lupus • Musculoskeletal Diseases • Musculoskeletal Pain • Pain • Rheumatology • Systemic Lupus Erythematosus • CD40LG

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 (ACR Convergence 2025) - P3 | "Treatment with DZP+SOC resulted in higher rates of achievement and time in the prognostically important endpoints of LLDAS and DORIS vs PBO+SOC. These findings provide further insights into the potential benefits of treatment with DZP for pts with SLE."

Clinical • P3 data • Immunology • Infectious Disease • Inflammatory Arthritis • Lupus • Systemic Lupus Erythematosus • CD40LG