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. Author manuscript; available in PMC: 2023 Jul 25.
Published in final edited form as: N Engl J Med. 2022 Feb 26;386(16):1505–1518. doi: 10.1056/NEJMoa2118813

Table 2.

Primary, Secondary, Post hoc, and Safety Analyses.*

Analysis Intervention Group (N = 600) Usual-Care Group (N = 601) Between-Group Comparison (95% CI) P Value
Primary analysis: severe asthma exacerbation
Total no. of exacerbations 585 680
Adjusted annualized rate per participant (95% CI) 0.69 (0.61–0.78) 0.82 (0.73–0.92) Hazard ratio: 0.85 (0.72–0.999) 0.048
Secondary analyses
Asthma Control Test
 Mean baseline score (95% CI) 14.7 (14.4–15.1) 14.5 (14.2–14.9)
 Overall mean postbaseline score (95% CI) 18.0 (17.7–18.3) 17.1 (16.7–17.4)
 Least-squares mean change from baseline (95% CI) 3.4 (3.1–3.6) 2.5 (2.3–2.8) Difference: 0.9 (0.5–1.2)
Asthma Symptom Utility Index
 Baseline mean score (95% CI) 0.67 (0.65–0.69) 0.67 (0.65–0.69)
 Overall mean postbaseline score (95% CI) 0.79 (0.77–0.80) 0.75 (0.74–0.76)
 Least-squares mean change from baseline (95% CI) 0.12 (0.11–0.13) 0.08 (0.07–0.09) Difference: 0.04 (0.02–0.05)
Annualized no. of days missed from work, school, or usual activities (95% CI) 13.4 (11.9–15.2) 16.8 (14.9–18.9) Rate ratio: 0.80 (0.67–0.95)
Post hoc analysis
Annualized no. of months with a reported asthma-related emergency department or urgent care visit (95% CI) 0.75 (0.65–0.87) 0.90 (0.77–1.04) Rate ratio: 0.84 (0.68–1.03)
Safety analysis
No. of asthma-related hospitalizations 70 84 Rate ratio: 0.84 (0.50–1.42)
*

Hazard ratio for the primary end point was adjusted for baseline characteristics and for a time-dependent covariate for the effects of coronavirus disease 2019. The widths of the confidence intervals for the secondary, post hoc, and safety analyses have not been adjusted for multiplicity and cannot be used to infer treatment effects.