Biogen Reports Stronger SLE Responses With Investigational Dapirolizumab

Litifilimab (Biogen) showed sustained improvement in skin assessments for cutaneous lupus patients through 52 weeks, per AMETHYST trial data. Response rates increased for those switched from placebo to litifilimab. The drug was well-tolerated, with significant patient-reported skin improvements.

Dutch regulators are investigating Biogen for allegedly restricting a blood test to patients using its MS drug Tysabri, potentially limiting access for competitors' treatments. The test is used to monitor a rare infection risk associated with Tysabri, Biogen's top-selling medication.

Biogen (BIIB) and UCB (UCB.BR) released Phase 3 data for Dapirolizumab pegol, showing lower disease activity in lupus patients. The trial met its primary endpoint, with 50% of patients showing improved BICLA scores compared to 35% on placebo. Post-hoc analysis showed 61.2% and 52.5% of patients responded in at least half or all active organ domains, respectively. Results will be presented at the ACR Convergence 2026 meeting.

Biogen (BIIB) and UCB reported Phase 3 trial results showing dapirolizumab pegol had higher response rates than placebo in lupus patients, with 61.2% vs. 43.2% improvement in organ domains and 52.5% vs. 36.8% improvement across all active domains. The treatment also showed higher rates of sustained low disease activity and remission, but had more adverse events. The companies are collaborating on its development.

UCB and Biogen reported post-hoc phase 3 analyses for dapirolizumab pegol in lupus. At week 48, 61.2% of patients on the drug showed a clinically meaningful response in at least half of their active organ domains, compared to 43.2% on placebo. The TRM-SLE tool, developed by an international group, was used for the first time in phase 3 data. Further validation is needed, and the tool was not a predefined endpoint.

Biogen and UCB reported that dapirolizumab pegol (DZP) showed higher response rates in SLE patients using the novel TRM-SLE measure in a Phase 3 study. DZP plus standard care achieved greater TRM-SLE-50 (61.2% vs 43.2%) and TRM-SLE-100 (52.5% vs 36.8%) responses than placebo. Separate analyses showed sustained low disease activity and remission with DZP.