Long-term safety and exploratory efficacy of fevipiprant in patients with inadequately controlled asthma: the SPIRIT randomised clinical trial

Table 5 On-treatment analysis of rate of moderate-to-severe asthma exacerbations during the total treatment period

Treatment	Annualized rate (95% CI)	Comparison	Rate ratio	95% CI
Overall population
Fevipiprant 150 mg (n = 748)	0.4 (0.3, 0.4)	Fevipiprant 150 mg/Placebo	0.58	(0.44, 0.77)
Fevipiprant 450 mg (n = 744)	0.3 (0.3, 0.4)	Fevipiprant 450 mg/Placebo	0.55	(0.41, 0.74)
		Fevipiprant 450 mg/Fevipiprant 150 mg	0.95	(0.75, 1.20)
Placebo (n = 245)	0.6 (0.5, 0.8)
Patients with blood eosinophil count ≥ 250 cells/μL
Fevipiprant 150 mg (n = 457)	0.4 (0.3, 0.5)	Fevipiprant 150 mg /Placebo	0.61	(0.43, 0.87)
Fevipiprant 450 mg (n = 460)	0.4 (0.4, 0.5)	Fevipiprant 450 mg/Placebo	0.64	(0.44, 0.92)
		Fevipiprant 450 mg/Fevipiprant 150 mg	1.04	(0.78, 1.40)
Placebo (n = 145)	0.7 (0.5, 0.9)

Negative binomial regression model: log (exacerbation rate) = randomization stratum
(fevipiprant 150 mg in LUSTER-1/LUSTER-2, fevipiprant 450 mg in LUSTER-1/LUSTER-2, Placebo in LUSTER-1/LUSTER-2, New patients) + treatment + severity of asthma (GINA steps 3, 4, and 5) + region + the natural logarithm of the number of asthma exacerbations in the 12 months prior to screening, and for overall population, plus blood eosinophil count at screening (≥ 250 cells/μL, < 250 cells/μL). For rollover patients, asthma exacerbation and blood eosinophil count recorded at screening of prior study are used. The log (duration of follow-up in years) is used as an off-set variable
A rate ratio < 1 favors treatment group in the numerator of the ratio

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