Subcutaneous Allergen Immunotherapy in Adults Allergic to House Dust Mites: A Phase 3 Randomized Controlled Trial.

Indeed, the treatment effect on the primary endpoint (CSMS(n)) was statistically highly significant ( p = 0.0031), with a trend for a significant difference in the treatment effect of −0.39 (95% CI, −0.64 to −0.13) points based on the subgroup analysis in the observed data, exceeding the 0.25‐point threshold.

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3.2 Efficacy The primary endpoint analysis indicated a borderline significant difference of the mean CSMS(n) between the SCIT 50,000 AUeq/mL and placebo treatment groups in the ITT population ( p = 0.0767), with a treatment effect of −0.12 (95% CI, −0.26 to 0.01) points that fell short of the prespecified minimal clinically relevant difference of 0.25 points.

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Results The primary endpoint showed a trend ( p = 0.0767) with a mean treatment effect of −0.12 (95% CI, −0.3 to 0) toward a favorable change in mean CSMS(n) for active compared to placebo treatment.

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The secondary and exploratory results show, in general, a favorable trend for the active product.

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While the primary endpoint did not reach statistical significance, the consistent findings across key secondary endpoints aligned with the directionality of the primary outcome.

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