Steroid use reduction and disease control:
In additional results from the Phase 3 PHOENYCS GO study, dapirolizumab pegol (DZP) plus standard of care was associated with sustained disease control at lower glucocorticoid doses through Week 48 compared with placebo plus standard of care, supporting reduced long-term steroid exposure
Reduced flare rates and immune marker improvements:
In other findings presented at EULAR 2026, improvements in immunological markers and reduced flare rates were observed, supporting the potential of dapirolizumab pegol to address the complex burden of SLE
BRUSSELS, Belgium and CAMBRIDGE, Mass., June 04, 2026 (GLOBE NEWSWIRE) --
UCB
(Euronext Brussels: UCB) and
Biogen Inc.
(Nasdaq: BIIB) today announced data, comprising two posters and three abstracts, at the European Alliance of Associations for Rheumatology (EULAR) 2026 Congress, demonstrating the clinical pro dapirolizumab pegol (DZP), an investigational biologic in patients with systemic lupus erythematosus (SLE).
Systemic lupus erythematosus (SLE) is a chronic autoimmune disease affecting multiple organs, including skin, joints and kidneys, often requiring long-term treatment to control disease activity.
1
Patients with SLE frequently experience flares, transient worsening of disease activity that can lead to permanent organ damage, increased morbidity, and even early mortality.
2
Many patients rely on steroid-based therapy to manage flares; however, prolonged steroid use is associated with significant cumulative toxicity, making steroid tapering while maintaining disease control a key goal in SLE management.
3,4
“Achieving and maintaining durable disease control while reducing glucocorticoid exposure is one of the central challenges in managing SLE,” said Megan E. B. Clowse, M.D., MPH, Chief of the Division of Rheumatology and Immunology, Duke University, and primary author of the PHOENYCS GO primary results. “The Phase 3 PHOENYCS GO data showed patients receiving dapirolizumab pegol were more likely to maintain disease control while tapering steroids – an important finding given strong evidence that cumulative steroid exposure and uncontrolled disease activity are major drivers of organ damage accrual, morbidity and mortality in SLE.”
Post hoc analyses displayed in one of the posters from the PHOENYCS GO program showed that, in patients with baseline glucocorticoid dose >7.5 mg/day prednisone equivalent, treatment with DZP plus standard of care was associated with a higher proportion of patients achieving control of disease activity while enabling glucocorticoid tapering to ≤7.5 mg/day through Week 48, compared with placebo plus standard of care.
5
Importantly, these findings suggest that higher proportions of patients receiving DZP plus standard of care versus placebo plus standard of care achieved sustained glucocorticoid tapering while also achieving BICLA response, achieving SRI-4 response, or remaining free from moderate or severe BILAG-2004 flares through Week 48.
5
“At UCB, our mission is to help improve the lives of people living with serious inflammatory diseases by advancing therapies that address unmet needs,” said Donatello Crocetta, Chief Medical Officer and Head of Global Medical Affairs at UCB. “These data showed the potential of dapirolizumab pegol to reduce long-term glucocorticoid use while maintaining disease control, an important goal for people living with SLE and the clinicians who care for them.”
Additional EULAR 2026 presentations highlighted the breadth of data from the PHOENYCS GO program, including:
Improvements in key immunological markers, including reduced anti-dsDNA antibodies and increased complement proteins C3 and C4 in patients with abnormal levels at baseline (Poster POS1364).
6
Lower rates of moderate or moderate/severe BILAG-2004 flares with DZP plus standard of care versus placebo plus standard of care through Week 48, using alternative definitions of flares to increase measurement sensitivity (Abstract AB1163).
7
Insights into how symptoms and flares are assessed in SLE, including fatigue as a burdensome patient-reported symptom that can be difficult to capture in clinical trials (Abstracts AB1184 and AB1125).
8,9
Together, these findings support the importance of tools that can measure patient experience and help inform more meaningful assessment of disease impact in both clinical practice and research.
8,9
“Systemic lupus erythematosus is a biologically complex disease, and these EULAR data further characterize dapirolizumab pegol’s impact across clinical, biological and patient-reported outcomes,” said Diana Gallagher, MD, Head of Immunology, MS and Alzheimer’s Development Units at Biogen. “Delivering this data reflects the strength of the UCB and Biogen collaboration and our shared commitment to advancing evidence that may help address the complex and multifaceted needs of people living with SLE.”
The EULAR data follow the recent publication of the Phase 3 PHOENYCS GO study in
The Lancet
, reporting clinically meaningful improvements in disease activity with dapirolizumab pegol at Week 48.
10
In the Phase 3 PHOENYCS GO study, DZP demonstrated a generally favorable safety profile, with safety findings consistent with previous DZP studies.
10,11
Treatment-emergent adverse events were more common with DZP plus standard of care versus placebo plus standard of care, while serious treatment-emergent adverse events were less frequent in the DZP plus standard of care arm, and discontinuations due to treatment-emergent adverse events were low in both groups.
10
About Dapirolizumab Pegol
Dapirolizumab pegol is a novel investigational humanized Fc-free polyethylene glycol (PEG)-conjugated antigen-binding (Fab’) fragment.
11
Dapirolizumab pegol inhibits CD40L signaling, which has been shown to reduce B-cell activation and autoantibody production, mitigate type 1 interferon (IFN) secretion and attenuate T-cell and antigen-presenting cell (APC) activation.
11
Dapirolizumab pegol is presently in Phase 3 clinical development for the treatment of systemic lupus erythematosus (SLE) under a collaboration between UCB and Biogen.
12,13
Dapirolizumab pegol is an investigational biologic currently in clinical development. The safety and efficacy have not been established, and it is not approved by any health authority worldwide.
About UCB
UCB, Brussels, Belgium ( ), is a global biopharmaceutical company focused on the discovery and development of innovative medicines and solutions to transform the lives of people living with severe diseases of the immune system or of the central nervous system. With approximately 9,000 people in approximately 40 countries, the company generated revenue of €7.7 billion in 2025. UCB is listed on Euronext Brussels (symbol: UCB).
About Biogen
Founded in 1978, Biogen is a leading biotechnology company that pioneers innovative science to deliver new medicines to transform patient’s lives and to create value for shareholders and our communities. We apply deep understanding of human biology and leverage different modalities to advance first-in-class treatments or therapies that deliver superior outcomes. Our approach is to take bold risks, balanced with return on investment to deliver long-term growth.
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This news release contains forward-looking statements, including, among others, relating to: the potential benefits, safety and efficacy of dapirolizumab pegol (DZP); the potential of dapirolizumab pegol to address the needs of people living with systemic lupus erythematosus (SLE), including the potential to help patients maintain disease control while tapering steroids; the anticipated benefits, risks and potential of Biogen's collaboration arrangements with UCB; the potential of Biogen's commercial business and pipeline programs, including dapirolizumab pegol; potential regulatory discussions, submissions and approvals and the timing thereof; and the risks and uncertainties associated with drug development and commercialization. These forward-looking statements may be accompanied by such words as “aim,” “anticipate,” “assume,” “believe,” “contemplate,” “continue,” “could,” “estimate,” “expect,” “forecast,” “goal,” “guidance,” “hope,” “intend,” “may,” “objective,” “outlook,” “plan,” “possible,” “potential,” “predict,” “project,” “prospect,” “should,” “target,” “will,” “would,” and other words and terms of similar meaning. Drug development and commercialization involve a high degree of risk, and only a small number of research and development programs result in commercialization of a product. Results in early-stage clinical trials may not be indicative of full results or results from later stage or larger scale clinical trials and do not ensure regulatory approval. You should not place undue reliance on these statements. Given their forward-looking nature, these statements involve substantial risks and uncertainties that may be based on inaccurate assumptions and could cause actual results to differ materially from those reflected in such statements.
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References:
Pons-Estel GJ, Alarcón GS, Scofield L, et al. Understanding the epidemiology and progression of systemic lupus erythematosus. Semin Arthritis Rheum. 2010;39(4):257-68.
Thanou A, Jupe E, Purushothaman M, et al. Clinical disease activity and flare in SLE: current concepts and novel biomarkers. J Autoimmun. 2021;119:102615. doi:10.1016/j.jaut.2021.102615.
Palmowski A, Pankow A, Terziyska K, et al. Continuing versus tapering low-dose glucocorticoids in patients with rheumatoid arthritis and systemic lupus erythematosus in states of low disease activity or remission: a systematic review and meta-analysis of randomised trials. Semin Arthritis Rheum. 2024;64:152349. doi:10.1016/j.semarthrit.2023.152349.
Fanouriakis A, Kostopoulou M, Alunno A, et al. 2019 update of the EULAR recommendations for the management of systemic lupus erythematosus. Ann Rheum Dis. 2019;78(6):736–45. doi:10.1136/annrheumdis-2019-215089.
Morand EF, Bertsias G, Carter LM, et al. Glucocorticoid-sparing maintenance of disease control in patients with systemic lupus erythematosus: 48-week results from a phase 3 trial of dapirolizumab pegol. Ann Rheum Dis. 2026;85(Suppl 1):POS0730.
Dörner T, Pisetsky DS, Fava A, et al. 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. Ann Rheum Dis. 2026;85(Suppl 1):POS1364.
Furie RA, Bertsias G, Carter LM, et al. 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. Ann Rheum Dis. 2026;85(Suppl 1):AB1163.
de la Loge C, Touma Z, Gordon C, et al. Measuring fatigue in systemic lupus erythematosus: measurement properties of the FATIGUE-PRO total score using data from a phase 3 trial of dapirolizumab pegol. Ann Rheum Dis. 2026;85(Suppl 1):AB1184.
Mosca M, Anjohrin S, Rawlings A, et al. Physicians’ perspectives on recognition of flares in patients with systemic lupus erythematosus in the clinic: real world insights from the United States and Europe. Ann Rheum Dis. 2026;85(Suppl 1):AB1125.
Clowse MEB, Isenberg DA, Merrill JT, et al. 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.
Lancet
. Published online May 29, 2026. doi:10.1016/S0140-6736(26)00691-4.
Furie RA, Bruce IN, Dörner T, et al. Phase 2 randomized, placebo-controlled trial of dapirolizumab pegol in patients with moderate to severe active systemic lupus erythematosus (SLE). Rheumatology (Oxford). 2021;60(11): 5397-407.
ClinicalTrials.gov. NCT04294667.
. Accessed May 29, 2026.
ClinicalTrials.gov. NCT06617325.
. Accessed May 29, 2026.
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