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Table 1 Distribution of baseline biomarker concentrations by treatment group in the STRATOS 1 all-comers population (full analysis set)

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

Biomarker

Combined placeboa(N = 400)

Tralo 300 mg Q2W(N = 398)

Tralo 300 mg Q4W(N = 404)

FeNO, ppb

n

398

395

397

Mean (SD)

29.6 (28.2)

30.5 (30.6)

29.2 (29.0)

Median (range)

20.2 (2.3–189.9)

20.3 (0.0–244.0)

20.4 (0.0–201.8)

Periostin, ng/ml

n

398

397

403

Mean (SD)

25.4 (11.8)

26.3 (12.7)

26.0 (11.1)

Median (range)

22.8 (7.6–83.4)

23.0 (9.5–91.6)

23.3 (8.7–78.8)

Eosinophils, cells/μl

n

393

393

395

Mean (SD)

254 (204)

308 (468)

296 (381)

Median (range)

200 (20–2,020)

210 (0–7,510)

200 (0–5,880)

DPP-4, ng/ml

n

399

397

404

Mean (SD)

262.0 (75.6)

264.0 (91.8)

267.0 (77.0)

Median (range)

251.0 (92.0–617.0)

246.0 (87.0–766.0)

254.0 (103.0–721.0)

IgE, IU/ml

n

395

392

399

Mean (SD)

432.0 (786.2)

429.2 (929.0)

440.4 (974.2)

Median (range)

165.9 (2.1–5,347)

141.8 (1.4–7,580)

141.8 (0.5–8,423)

  1. DPP-4 Dipeptidyl peptidase-4, FeNO Fractional exhaled nitric oxide; IgE Immunoglobulin E, IU International units, SD Standard deviation, Q2W Every 2 weeks, Q4W Every 4 weeks, Tralo Tralokinumab
  2. aThe placebo treatment group is a pooled treatment group (placebo Q2W + placebo Q4W)