Study design and analysis population
dysphagia, EoE, dysphagia symptoms
DYSPHAGIA, SECONDARY, EOE
R668-EE-1774 (NCT03633617) was a phase 3, randomized, double-blind, placebo-controlled clinical trial to investigate the efficacy and safety of dupilumab in adult and adolescent patients (aged ≥ 12 years) with EoE [The study comprised 3 main parts and a follow-up period: Part A (N = 81) and Part B (N = 240), each consisting of a 24-week double-blind treatment period; Part C, a 28-week extended active treatment period (in which Part B patients remained blinded to current treatment regimen and both Part A and Part B patients remained blinded to prior treatment allocation); and a 12-week follow-up period after the end of the extended active treatment period for participants who entered into Part C or following the end of Parts A or B for participants who did not enter Part C. Given the larger sample size in Part B relative to Part A, the primary psychometric analyses reported here were conducted using EoE-IQ data from Part B; analyses conducted with Part A data yielded similar findings (data not shown). Baseline characteristics are presented for the PRO analysis population, which included all randomized patients in Part B who completed at least 1 of 3 PRO measures administered at baseline in the trial: the EoE-IQ; the DSQ, which evaluated dysphagia symptoms; or the EoE Symptom Questionnaire (EoE-SQ), which evaluated EoE symptoms other than dysphagia (N = 239 for Part B). Absolute changes in frequency and severity of symptoms evaluated by the EoE-SQ from baseline to week 24 were secondary endpoints in R668-EE-1774. For all psychometric analyses, no imputation of missing responses was performed; only observed responses were included.