Table 2.
Efficacy analysis of patients with moderate-to-severe atopic dermatitis (full analysis set).
| Items |
CM310 high-dose
(n = 40) |
CM310 low-dose
(n = 40) |
Placebo
(n = 40) |
|---|---|---|---|
| Patients with EASI-75 at week 16 | |||
| Number, n (%) | 28 (70) | 26 (65) | 8 (20) |
| Difference (95% CI) vs. placebo, % | 50 (31, 69) | 45 (26, 64) | |
| P value vs. placebo | <0.0001 | <0.0001 | |
| Patients with IGA 0–1 and ≥2-point improvement from baseline at week 16 | |||
| Number, n (%) | 9 (22) | 12 (30) | 5 (12) |
| Difference (95% CI) vs. placebo, % | 10 (–6, 26) | 18 (–0, 35) | |
| P value vs. placebo | 0.3781 | 0.0993 | |
| Patients with ≥2-point improvement in IGA from baseline at week 16 | |||
| Number, n (%) | 19 (48) | 22 (55) | 5 (12) |
| Difference (95% CI) vs. placebo, % | 35 (16, 54) | 42 (24, 61) | |
| P value vs. placebo | 0.0012 | 0.0001 | |
| Patients with EASI-90 at week 16 | |||
| Number, n (%) | 16 (40) | 19 (48) | 4 (10) |
| Difference (95% CI) vs. placebo, % | 30 (12, 48) | 38 (19, 56) | |
| P value vs. placebo | 0.0038 | 0.0004 | |
| Patients with EASI-50 at week 16 | |||
| Number, n (%) | 34 (85) | 32 (80) | 21 (52) |
| Difference (95% CI) vs. placebo, % | 32 (14, 52) | 28 (8, 47) | |
| P value vs. placebo | 0.0033 | 0.0172 | |
| Patients with ≥3-point reduction in weekly average of daily PP-NRS score from baseline at week 16 | |||
| Number, n (%) | 24 (60) | 23 (58) | 10 (25) |
| Difference (95% CI) vs. placebo, % | 35 (15, 55) | 33 (12, 53) | |
| P value vs. placebo | 0.0030 | 0.0060 | |
| Patients with ≥4-point reduction in weekly average of daily PP-NRS score from baseline at week 16 | |||
| Number, n (%) | 18 (45) | 15 (38) | 5 (12) |
| Difference (95% CI) vs. placebo, % | 33 (14, 51) | 25 (7, 43) | |
| P value vs. placebo | 0.0026 | 0.0188 | |
| LS mean percent change in weekly average of daily PP-NRS score from baseline to EOS, mean ± SE | –47.6 ± 5.8 | –33.0 ± 5.8 | –17.1 ± 6.4 |
| Difference (95% CI) vs. placebo, % | –30.5 (–47.6, –13.5) | –15.8 (–33.0, 1.3) | |
| LS mean percent change in EASI score from baseline to EOS, mean ±SE | –81.9 ± 5.2 | –70.5 ± 5.3 | –51.2 ± 5.9 |
| Difference (95% CI) vs. placebo, % | –30.7 (–46.4, –15.0) | –19.2 (–35.0, –3.4) | |
| LS mean percent change in AD-affected %BSA from baseline to EOS, mean ± SE | –74.2 ± 6.7 | –62.6 ± 6.7 | –33.6 ± 7.6 |
| Difference (95% CI) vs. placebo, % | –40.6 (–60.6, –20.6) | –29.0 (–49.0, –9.0) | |
| LS mean change in DLQI score from baseline to EOS, mean ± SE | –10.3 ± 1.1 | –6.5 ± 1.1 | –4.1 ± 1.2 |
| Difference (95% CI) vs. placebo, % | –6.2 (–9.4, –2.9) | –2.4 (–5.6, 0.9) |
%BSA: Percentage of body surface area; AD: Atopic dermatitis; CI: Confidence interval; DLQI: Dermatology Life Quality Index; EASI: Eczema Area and Severity Index; EOS: End-of-study; IGA: Investigator's Global Assessment; LS: Least-squares; PP-NRS: Peak pruritus Numerical Rating Scale; SE: Standard error.