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Fig. 6 | BMC Pulmonary Medicine

Fig. 6

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

Fig. 6

SIDES subgroups and tralokinumab treatment effect in the STRATOS 1 all-comers population (full analysis set)*. *Estimates within subgroups were based on negative binomial models including treatment group, geographical region, age and number of exacerbations in the previous year. The log of each participants’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. The lower CI limits truncated at − 75%. Results are shown for the tralokinumab Q2W and pooled placebo arms based on a negative binomial model adjusted for baseline covariates. †The placebo treatment group is a pooled treatment group (placebo Q2W + placebo Q4W). ‡Complementary refers to the subgroup of participants not in the subgroup of interest, i.e. participants with baseline biomarker concentrations of: DPP-4 ≤ 204.8 ng/ml; eosinophils ≤140 cells/μl; FeNO ≤32.3 ppb; IgE > 0.9 ng/ml; periostin ≤27.4 ng/ml. AAER, annualised asthma exacerbation rate; CI, confidence interval; DPP-4, dipeptidyl peptidase-4; FeNO, fractional exhaled nitric oxide; IgE, immunoglobulin E; Q2W, every 2 weeks; SIDES, Subgroup Identification based on Differential Effect Search

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