Chapter 12, Problem 53SE

Drug for Asthma (Example 7) Eosinophils are a form of white blood cell that is often present in people suffering from allergies. People with asthma and high levels of eosinophils who used steroid inhalers were given either a new drug or a placebo. Read extracts from the abstract of this study that appear below, and then evaluate the study. See page 612 for questions and guidance.

"Methods: We enrolled patients with persistent, moderate-to-severe asthma and a blood eosinophil count of at least 300 cells per microliter ... who used medium-dose to high-dose inhaled glucocorticoids.... We administered dupilumab (300 mg) or placebo subcutaneously once weekly. The primary end point was the occurrence of an asthma exacerbation (worsening].

Results: A total of 52 patients were [randomly] assigned to the dupilumab group. and 52 patients were [randomly] assigned to the placebo group.... Three patients had an asthma exacerbation with dupilumab $$\left(6\%\right)$$versus 23 with placebo $$\left(44\%\right),$$corresponding to an $$87\%$$reduction with dupilumab (odds ratio, $$0.08;95\%$$confidence interval, $$0.02\text{ to }0.28;P<0.000$$).

Conclusions: In patients with persistent. moderate.co-severe asthma and elevated eosinophil levels who used inhaled glucocorticoids and LABAs, dupilumab therapy, as compared with placebo, was associated with fewer asthma exacerbations [worsenings]."