Table 2 Multiplicity-tested efficacy outcomes

From: Stapokibart for moderate-to-severe seasonal allergic rhinitis: a randomized phase 3 trial

Outcomea

Stapokibart (n = 50)

Placebo (n = 58)

LS mean difference

P valuea

LS mean (s.e.m.)

LS mean (s.e.m.)

(95% CI)

 

Primary outcome

 Mean change from baseline in daily rTNSS during the 2-week treatmentb

−3.6 (0.3)

−2.3 (0.3)

−1.3 (−2.0 to −0.6)

0.0008

Secondary outcome

 Mean change from baseline in daily rTOSS during the 2-week treatmentc

−2.6 (0.3)

−1.9 (0.3)

−0.7 (−1.3 to 0.0)

0.039

 Mean change from baseline in daily rTNSS during the 4-week treatmentb

−4.9 (0.4)

−3.2 (0.4)

−1.7 (−2.5 to −0.8)

0.0002

 Mean change from baseline in daily rTOSS during the 4-week treatmentc

−3.7 (0.3)

−2.9 (0.3)

−0.8 (−1.4 to −0.2)

0.016

 Change from baseline in total RQLQ score at week 2d

−2.5 (0.2)

−1.6 (0.2)

−0.9 (−1.4 to −0.4)

0.0003

 Change from baseline in total RQLQ score at week 4d

−3.5 (0.2)

−2.5 (0.2)

−1.0 (−1.5 to −0.5)

<0.0001

  1. aListed in the order of hierarchical testing. All outcomes were analyzed using the ANCOVA model, with the baseline value of the given outcome, study site and treatment group as covariates. Differences in LS means and the corresponding 95% CI were calculated together with the P value (two sided). The overall type I error was controlled by step-down test procedures. All the data of a.m. and p.m. rTNSS and rTOSS in the 4 weeks of treatment were collected, and thus, there was no missing data-handling issue for rTNSS and rTOSS. Missing data for RQLQ were imputed by the LOCF method.
  2. brTNSS is calculated by summing up the individual scores for nasal congestion, runny nose, nasal itching and sneezing reported over the past 12 h; the individual nasal symptom score ranges from 0 (no symptom) to 3 points (severe); total scores range from 0 to 12, with lower scores indicating less severe nasal symptoms.
  3. crTOSS is calculated by summing up the individual scores for itching and burning eyes, tearing and watering eyes, and eye redness reported over the past 12 h; the individual ocular symptom score ranges from 0 (no symptom) to 3 points (severe); total scores range from 0 to 9, with lower scores indicating less severe ocular symptoms.
  4. dRQLQ is a 28-item instrument specifically designed to assess the QOL status in adult patients with rhinoconjunctivitis; total scores range from 0 to 6, with lower scores indicating a higher QOL. s.e.m., standard error of the mean.
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