Table 2.
Efficacy endpoints at week 12 (full analysis set)
| SHR0302 4 mg [n = 35] | SHR0302 8 mg [n = 35] | Placebo [n = 35] | |
|---|---|---|---|
| IGA responsea | 9 (25.7%) | 19 (54.3%) | 2 (5.7%) |
| 90% CI | 13.6%, 37.9%i | 40.4%, 68.1%i | 0.0%, 12.2%i |
| Compared with the placebo group | |||
| Difference | 20.0% | 48.6% | |
| 90% CI | 6.2%, 33.8%i | 33.3%, 63.9%i | |
| p-Value | 0.022i | <0.001i | |
| EASI score ≥50% (EASI50)b | 24 (68.6%) | 29 (82.9%) | 15 (42.9%) |
| Compared with the placebo group | |||
| Difference | 25.7% | 40.0% | |
| 90% CI | 6.9%, 44.6%i | 22.7%, 57.3%i | |
| p-Value | 0.030i | <0.001i | |
| EASI score ≥75% (EASI75)c | 18 (51.4%) | 26 (74.3%) | 8 (22.9%) |
| Compared with the placebo group | |||
| Difference | 28.6% | 51.4% | |
| 90% CI | 10.4%, 46.7%i | 34.6%, 68.3%i | |
| p-Value | 0.013i | <0.001i | |
| EASI score ≥90% (EASI90)d | 11 (31.4%) | 16 (45.7%) | 3 (8.6%) |
| Compared with the placebo group | |||
| Difference | 22.9% | 37.1% | |
| 90% CI | 7.8%, 37.9%i | 21.3%, 53.0%i | |
| p-Value | 0.017i | <0.001i | |
| NRS score ≥3 (NRS-3)e | 23 (65.7%) | 26 (74.3%) | 8 (22.9%) |
| Compared with the placebo group | |||
| Difference | 42.9% | 51.4% | |
| 90% CI | 25.2%, 60.5%i | 34.6%, 68.3%i | |
| p-Value | <0.001i | <0.001i | |
| SCORAD score ≥50% (SCORAD50)f | 17 (48.6%) | 25 (71.4%) | 8 (22.9%) |
| Compared with the placebo group | |||
| Difference | 25.7% | 48.6% | |
| 90% CI | 7.6%, 43.9%i | 31.4%, 65.7%i | |
| p-Value | 0.025i | <0.001i | |
| SCORAD score ≥75% (SCORAD75)g | 10 (28.6%) | 12 (34.3%) | 3 (8.6%) |
| Compared with the placebo group | |||
| Difference | 20.0% | 25.7% | |
| 90% CI | 5.2%, 34.8%i | 10.4%, 41.0%i | |
| p-Value | 0.031i | 0.009i | |
| SCORAD score ≥90% (SCORAD90)h | 2 (5.7%) | 3 (8.6%) | 0 |
| Compared with the placebo group | |||
| Difference | 5.7% | 8.6% | |
| 90% CI | −2.1%, 16.9%j | 0.3%, 20.7j | |
| p-Value | 0.493j | 0.239j |
CI confidence interval, EASI Eczema Area and Severity Index, FAS full analysis set, IGA Investigator’s Global Assessment, NRS Numerical Rating Scale, SCORAD Scoring Atopic Dermatitis
aIGA response was defined as an IGA score of 0/1 (complete or almost complete clearance of skin lesions) with an improvement in IGA score by ≥2 from baseline. The following situations would be regarded as nonresponding: (1) IGA 2/3/4/5; (2) IGA score of 0/1, but an improvement in IGA score of <2 from baseline; (3) missing visits; (4) early withdrawal from the treatment
bEASI50: EASI score improved by ≥50% from baseline
cEASI75: EASI score improved by ≥75% from baseline
dEASI90: EASI score improved by ≥90% from baseline.
The following situations would be considered as nonresponding to EASI50 (the same rules applied to EASI75/EASI90): (1) EASI score improved by <50% from baseline; (2) missing visits; (3) early withdrawal from the treatment
eTwo patients in the placebo group had a baseline NRS of <3, therefore these patients would not show an improvement of ≥3 from baseline; the other two treatment groups had no patients with a baseline NRS of <3. The denominator of each treatment group was the number of patients in the FAS of each treatment group
fSCORAD50: SCORAD score improved by ≥50% from baseline
gSCORAD75: SCORAD score improved by ≥75% from baseline
hSCORAD90: SCORAD score improved by ≥90% from baseline
The following situations would be considered as nonresponding to SCORAD50 (the same rules applied to SCORAD75/SCORAD90): (1) SCORAD score improved by <50% from baseline; (2) missing visits; (3) early withdrawal from the treatment
Both remote visits and delayed visits were included in the analysis
iThe confidence interval and p-value were analyzed using the normal approximation method
jThe confidence interval and p-value were analyzed using Fisher's exact test
The efficacy analysis was carried out using Hochberg's incremental test