Tozorakimab to Prevent COPD Exacerbations.
Frank C Sciurba, Henrik Watz, Arnaud Bourdin et al.
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In 30 seconds
Two replicate, multicenter phase 3 randomized trials (OBERON and TITANIA) tested add-on tozorakimab versus placebo in current or former smokers with COPD and prior-year exacerbations despite stable inhaled maintenance therapy. Treatment was given every 4 weeks for 52 weeks, with no blood eosinophil eligibility threshold. In the overall populations, annualized moderate or severe exacerbation rates were 1.41 versus 2.00 events in OBERON and 1.44 versus 2.03 in TITANIA, favoring tozorakimab. Rates were also significantly lower among former smokers in both trials.
Key findings
- In OBERON, overall annualized exacerbation rates were 1.41 events with tozorakimab and 2.00 with placebo (rate ratio, 0.70; 95% CI, 0.58 to 0.85; P<0.001).
- In TITANIA, overall annualized exacerbation rates were 1.44 events with tozorakimab and 2.03 with placebo (rate ratio, 0.71; 95% CI, 0.59 to 0.84; P<0.001).
- Among former smokers, rates were 1.34 versus 1.90 events in OBERON and 1.37 versus 2.07 in TITANIA, favoring tozorakimab.
- Adverse events occurred in 70.4% versus 77.2% of patients in OBERON and 80.1% versus 79.8% in TITANIA (tozorakimab versus placebo).
Why it matters
Exacerbations remain a concern for people with COPD despite inhaled maintenance therapy. These two phase 3 trials found lower moderate or severe exacerbation rates when an interleukin-33 inhibitor was added, both among former smokers and in the overall population, which included current smokers. The findings provide clinical evidence for targeting this pathway in a population not selected by blood eosinophil count.
What to keep in mind
The abstract reports outcomes over 52 weeks; longer-term effects and safety are not established by these results.