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Biogen reports stronger lupus treatment response rates
Key points
- Biogen and UCB reported additional Phase 3 analyses showing higher lupus treatment response rates with dapirolizumab pegol than placebo.
- Response rates reached 61.2% versus 43.2% for improvement in at least half of active organ domains, and 52.5% versus 36.8% across all active domains.
- The companies are evaluating dapirolizumab pegol as a potential lupus treatment, although the new response measure requires further validation.
Biogen (NASDAQ:BIIB) and UCB reported additional Phase 3 findings associating dapirolizumab pegol with higher treatment response rates than placebo in patients with systemic lupus erythematosus.
The new findings came from a post-hoc analysis of the PHOENYCS GO trial, which previously met its primary Week 48 endpoint with a 50% response rate for dapirolizumab pegol versus 35% for placebo.
The companies reported response rates of 61.2% versus 43.2% for improvement in at least half of active organ domains, and 52.5% versus 36.8% for improvement across all active domains.
Separate post-hoc analyses also found higher rates of sustained low disease activity and remission across Weeks 40, 44 and 48, while the new Treatment Response Measure requires further validation.
Treatment-emergent adverse events were more common among patients receiving dapirolizumab pegol, although serious adverse events were less frequent than in the placebo group.
The findings add to the companies' clinical development programme for dapirolizumab pegol, which is being investigated as a treatment for systemic lupus erythematosus, an autoimmune disease that can affect multiple organs.
Biogen and UCB are evaluating the treatment's potential through their collaboration, with the latest analyses providing additional information on treatment response, disease activity and safety.
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