Table 1.
Primary, Secondary, and Exploratory Endpoints and Post Hoc Analyses
| Type | Endpoint | Reported Comparison Between Groups | ||
|---|---|---|---|---|
| SCIT+dupilumab vs SCIT | Dupilumab vs Placebo | SCIT+dupilumab vs Dupilumab | ||
| Primary | % Change from pretreatment baseline in TNSS AUC (0–1 h post peak TNSS)*,†,‡,§ | X | ||
| Secondary | Absolute change from pretreatment baseline in TNSS AUC (0–1 h post peak TNSS)*,†,‡,§ | X | ||
| % Change and absolute change from pretreatment baseline in TNSS AUC (0–1 h post peak TNSS)*,†,‡,§ | X | X | ||
| % Change and absolute change from pretreatment baseline sIgG4 and sIgE† | X | |||
| Change from pretreatment baseline in log-transformed value of serum sIgG4 to sIgE ratio (log [sIgG4/sIgE])† | X | |||
| Incidence rates of TEAEs and serious TEAEs through end of study | ||||
| Exploratory | % Change and absolute change from baseline in peak TNSS‡ | X | X | |
| % Change from baseline in TOSS AUC (0–1 h post peak TNSS)§ | X | X | ||
| % Change from pretreatment baseline in PNIF AUC (0–1 h)*,§ | X | X | ||
| % Change from baseline in SPT with serial allergen titration, as measured by AUC of average wheal sizes (diameter) over allergen concentrations after the challenge (early-phase reaction)*,§ | X | X | ||
| % Change from baseline at Week 17 in wheal size diameter induced by skin TG intradermal injection 6 h after challenge (LPR) | X | X | ||
| % Change and absolute change from pretreatment baseline in sIgG† | X | |||
| Change from pretreatment baseline in (log [sIgG/sIgE])† | X | |||
| Post hoc | Analysis of completers and non-completers (patients randomized to SCIT+dupilumab and dupilumab) at Week 17 was also performed for absolute change in sIgE, sIgG4, sIgG, log (sIgG4/sIgE), and log (sIgG/sIgE) | |||
Notes: *Following NAC with timothy grass extract. †Change from pretreatment baseline at Week 17. ‡TNSS is defined as the highest TNSS attained during 0–1 h following NAC. §AUC is calculated using the trapezoid rule (see Algorithm for calculation of AUC in this article’s Online Repository at https://www.dovepress.com/).
Abbreviations: AUC, area under the curve; BL, baseline; LPR, late-phase reaction; NAC, nasal allergen challenge; PNIF, peak nasal inspiratory flow; SCIT, subcutaneous immunotherapy; sIgE, timothy grass–specific immunoglobulin E; sIgG, timothy grass–specific immunoglobulin G; sIgG4, serum timothy grass–specific IgG4; SPT, skin prick test; TEAE, treatment-emergent adverse event; TG, timothy grass; TNSS, total nasal symptom score; TOSS, total ocular symptom score.