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

Table 3 Analysis of annualised asthma exacerbation rate reduction by baseline FeNO concentration in the STRATOS 1 all-comers population (full analysis set)^a

FeNO cut-off, ppb	Tralo Q2W vs. combined placebo^b, n	Rate ratio (95% CI)	p-value
≥30	133 vs. 135	0.71 (0.46, 1.10)	0.121
< 30	262 vs. 263	1.10 (0.79, 1.54)	0.559
≥31	128 vs. 127	0.69 (0.44, 1.07)	0.098
< 31	267 vs. 271	1.11 (0.80, 1.54)	0.533
≥32	124 vs. 124	0.67 (0.43, 1.05)	0.078
< 32	271 vs. 274	1.12 (0.81, 1.56)	0.482
≥33	118 vs. 122	0.64 (0.40, 1.02)	0.058
< 33	277 vs. 276	1.13 (0.82, 1.55)	0.460
≥34	113 vs. 114	0.64 (0.40, 1.03)	0.066
< 34	282 vs. 284	1.12 (0.81, 1.53)	0.496
≥35	105 vs. 108	0.62 (0.38, 1.01)	0.056
< 35	290 vs. 290	1.12 (0.82, 1.53)	0.478
≥36	103 vs. 106	0.61 (0.37, 1.01)	0.052
< 36	292 vs. 292	1.12 (0.82, 1.52)	0.488
≥37	97 vs. 102	0.56 (0.34, 0.94)	0.028
< 37	298 vs. 296	1.14 (0.84, 1.56)	0.391
≥38	94 vs. 98	0.58 (0.35, 0.98)	0.040
< 38	301 vs. 300	1.12 (0.82, 1.52)	0.468
≥39	92 vs. 92	0.66 (0.38, 1.12)	0.122
< 39	303 vs. 306	1.04 (0.77, 1.41)	0.789
≥40	88 vs. 89	0.67 (0.39, 1.16)	0.151
< 40	307 vs. 309	1.03 (0.76, 1.39)	0.847

CI Confidence interval, FeNO Fractional exhaled nitric oxide, Q2W Every 2 weeks, Q4W Every 4 weeks, Tralo Tralokinumab
^aRate ratios and p-values are from a negative binomial model analysis, with treatment group, geographical region, age group, periostin group at baseline, number of exacerbations in the previous year and treatment^*biomarker group included as covariates. The log of each participant’s corresponding follow-up time was used as an offset variable in the model to adjust for participants having different exposure times during which asthma exacerbations occurred. Total follow-up time was defined as the time from randomisation to Week 52 or last contact if the participant was lost to follow-up. No multiplicity adjustments were made and all p-values stated are nominal; values <0.05 are bolded
^bThe placebo treatment group is a combined treatment group (placebo Q2W + placebo Q4W)

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