Clinical trialsCompany release

UCB and Biogen report post-hoc lupus data for dapirolizumab pegol using new TRM-SLE measure

UCB · Mon 09 Nov 2026

Post-hoc analyses of the Phase 3 PHOENYCS GO study, shown at ACR Convergence 2026, favour the investigational drug over placebo, but the measure is unvalidated and the analyses fall outside any regulatory filing.

UCB and Biogen presented post-hoc analyses of the Phase 3 PHOENYCS GO study of investigational dapirolizumab pegol in systemic lupus erythematosus (SLE) at ACR Convergence 2026 on 9 November 2026. The analyses applied a novel measure, TRM-SLE, for the first time.

Through Week 48, more patients receiving dapirolizumab pegol plus standard of care than placebo plus standard of care showed a meaningful response in at least half of their active organ domains: 61.2% versus 43.2%. A response in all active organ domains was seen in 52.5% of patients on dapirolizumab pegol versus 36.8% on placebo.

Separate analyses reported higher rates of sustained low disease activity and of remission in the dapirolizumab pegol group. The summary of the presentation does not give the figures for those endpoints.

The companies stressed that the analyses were not pre-specified and are not part of any regulatory submission. They also noted that the TRM-SLE measure requires further validation, so the findings should be read as exploratory.

What it means for your team

  • The data are post-hoc and exploratory; they do not form part of a regulatory submission and should not be treated as confirmatory evidence of efficacy.
  • TRM-SLE is a new measure that still needs validation, so its acceptability to regulators and payers as an outcome in SLE is unproven.
  • Market-access teams may watch whether organ-domain-based response and sustained low disease activity or remission feature in future lupus evidence discussions, though nothing in this release indicates that they will.

Company's press release: UCB ↗

Article written by VigiEye from the official source (UCB). Claims are the company's own. AI-assisted; check the source before acting.

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