Lupus: UCB and Biogen Release Positive Phase 3 Results in The Lancet
UCB and Biogen announced on Monday the publication in The Lancet of the phase 3 results of dapirolizumab pegol (DZP) in the treatment of systemic lupus erythematosus. The PHOENYCS GO study demonstrated a statistically significant improvement in disease activity at week 48 compared to placebo, supporting the continued development of the drug candidate.
Significant Improvement in Lupus Activity by Week 48
The PHOENYCS GO trial achieved its primary endpoint: 50% of patients treated with dapirolizumab pegol in addition to standard treatment showed a BICLA response (a composite measure of clinically meaningful improvement in lupus activity) at week 48, compared to 35% in the placebo group. This measure assesses clinically meaningful improvement across all affected systems without worsening in other areas of lupus. Favorable results for dapirolizumab pegol were also observed in several secondary endpoints, including severe lupus flares, serological markers (double-stranded DNA antibodies, C3 and C4 complement), as well as joint and skin symptoms. The trial also showed clinically significant improvements in fatigue, a symptom often identified by patients as one of the most debilitating aspects of lupus.
Confirmed Glucocorticoid-Sparing Potential
By week 48, a larger proportion of patients in the dapirolizumab pegol group had successfully reduced their dose of glucocorticoids from more than 7.5 mg/day to 7.5 mg/day or less. This result suggests a glucocorticoid-sparing effect of dapirolizumab pegol and is in line with a gradual reduction according to treatment guidelines. The safety profile of dapirolizumab pegol was generally favorable. Adverse events during treatment (82.6% in the dapirolizumab pegol group versus 75.0% in the placebo group) were more frequent with the drug candidate, while serious adverse events were less frequent (10.0% versus 14.8% respectively). Discontinuations due to adverse events remained low in both groups (4.7% and 3.7%).
Continuation of the Clinical Development Program
These positive phase 3 results support the continuation of the development of dapirolizumab pegol. UCB and Biogen are continuing the PHOENYCS FLY confirmation trial, currently recruiting patients. This trial is intended to support future regulatory submissions. Additional data from the PHOENYCS GO study are to be presented at the annual European Congress of Rheumatology (EULAR) this week.
