Application of structured statistical analyses to identify a biomarker predictive of enhanced tralokinumab efficacy in phase III clinical trials for severe, uncontrolled asthma

Table 6 Comparison of FeNO and periostin as a predictive biomarker in the STRATOS 1 all-comers population (full analysis set)

	FeNO ≥37 ppb	Periostin > 27.4 ng/ml
Prevalence in STRATOS 1, % (n/N)	23.7 (285/1,202)	32.9 (395/1,202)
Observed AAER reduction (95% CI) for tralo Q2W vs. combined placebo^a, %	44 (6, 66)	31 (−4, 54)
Interaction test p-value^†	0.038	0.478
Secondary endpoints enhanced for tralo Q2W	Consistent effect with FEV₁, AQLQ, ACQ-6	No consistent effect observed
Observations for tralo Q4W	Consistent	Consistent effect only with the AAER reduction endpoint

ACQ-6 Asthma Control Questionnaire (6-item), AAER Annualised asthma exacerbation rate, AQLQ Standardised Asthma Quality of Life Questionnaire for 12 Years and Older, CI Confidence interval, FeNO Fractional exhaled nitric oxide, FEV₁ Forced expiratory volume in 1 s, Q2W Every 2 weeks, Q4W Every 4 weeks, Tralo Tralokinumab
^aThe placebo treatment group is a combined treatment group (placebo Q2W + placebo Q4W)
^†p-value of 0.10 is considered nominally significant (depicted in bold)

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