Table 3.
Efficacy scores, safety profile, treatment discontinuation, causes of failure (F), and drug survival analyses.
| Variable | Total | Group 1 | Group 2 | p value | Odds ratio (OR) | |||
|---|---|---|---|---|---|---|---|---|
| Treatment outcomes | VAS pruritus pre- | Mean ± SD | 8.33 ± 2.22 | 8.45 ± 2.06 | 8.10 ± 2.50 | 0.3297 | ||
| VAS pain pre- | Mean ± SD | 6.08 ± 3.49 | 5.96 ± 3.51 | 6.32 ± 3.46 | 0.478 | |||
| VAS sleep pre- | Mean ± SD | 6.60 ± 3.5 | 6.85 ± 3.29 | 6.12 ± 3.90 | 0.187 | |||
| EASI week 0 | Mean ± SD | 26,07 ± 9.66 | 27.89 ± 9.97 | 22.50 ± 7.96 | 0.0001* | |||
| BSA week 0 | Mean ± SD | 22.10 ± 15.33 | 24.42 ± 16.62 | 17.84 ± 12.18 | 0.0007* | |||
| IGA week 0 | Mean ± SD | 3.74 ± 0.70 | 3.74 ± 0.70 | 3.74 ± 0.68 | 0.97278 | |||
| EASI week 16 | Mean ± SD | 6,36 ± 8,30 | 7,59 ± 9,19 | 3,67 ± 5,00 | 0.0003* | |||
| EASI50 w16 | Percentage | 84.9 | 83.6 | 87.7 | 0.62264 | OR 0.65 (0.26–1.62) | ||
| EASI75 w16 | Percentage | 62.0 | 56.6 | 73.7 | 0.04194* | OR 0.45 (0.23–0.89) | ||
| EASI90 w16 | Percentage | 43.6 | 36.9 | 57.9 | 0.01317* | OR 0.41 (0.22–0.79) | ||
| EASI 100 w16 | Percentage | 25.1 | 19.7 | 36.8 | 0.02249* | OR 0.41 (0.2–0.83) | ||
| BSA week 16 | Mean ± SD | 6.02 ± 10.33 | 7.64 ± 11.85 | 2,47 ± 3,94 | 0.0001* | |||
| IGA week 16 | Mean ± SD | 1.25 ± 1.15 | 1.36 ± 1.15 | 1.02 ± 1.13 | 0.06152 | |||
| EASI week 24 | Mean ± SD | 3.48 ± 7.53 | 4.35 ± 8.76 | 1,60 ± 2,99 | 0.0035* | |||
| EASI50 w24 | Percentage | 95.1 | 94.5 | 96.2 | 0.95794 | OR 0.59 (0.12–2.96) | ||
| EASI75 w24 | Percentage | 84.6 | 81.8 | 90.4 | 0.23955 | OR 0.46 (0.16–1.29) | ||
| EASI90 w24 | Percentage | 66.7 | 62.7 | 75.0 | 0.17116 | OR 0.55 (0.26–1.14) | ||
| EASI 100 w24 | Percentage | 46.3 | 40.0 | 59.6 | 0.0301* | OR 0.44 (0.23–0.87) | ||
| BSA week 24 | Mean ± SD | 3.30 ± 7.93 | 4.08 ± 9.22 | 1.63 ± 3.42 | 0.0149* | |||
| IGA week 24 | Mean ± SD | 0.74 ± 0.95 | 0.82 ± 1.01 | 0.56 ± 0.80 | 0.07401 | |||
| EASI week 52 | Mean ± SD | 2.15 ± 4.13 | 2.23 ± 3.68 | 1.95 ± 5.14 | 0.7554 | |||
| EASI50 w52 | Percentage | 96.2 | 95.7 | 97.4 | 1 | OR 0.6 (0.07–5.56) | ||
| EASI75 w52 | Percentage | 90.8 | 92.5 | 86.8 | 0.49639 | OR 1.86 (0.55–6.28) | ||
| EASI90 w52 | Percentage | 75.6 | 74.2 | 78.9 | 0.72588 | OR 0.77 (0.31–1.9) | ||
| EASI 100 w52 | Percentage | 55.0 | 49.5 | 68.4 | 0.0715 | OR 0.45 (0.2–1.0) | ||
| BSA week 52 | Mean ± SD | 1.94 ± 5.71 | 1.60 ± 2.59 | 2.76 ± 9.89 | 0.4790 | |||
| IGA week 52 | Mean ± SD | 0.59 ± 0.85 | 0.64 ± 0.81 | 0.47 ± 0.92 | 0.34114 | |||
| VAS pruritus post- | Mean ± SD | 2.80 ± 3,01 | 2.77 ± 2.91 | 2.88 ± 3,23 | 0.8329 | |||
| VAS pain post- | Mean ± SD | 1.45 ± 2.91 | 1.33 ± 2.79 | 1.71 ± 3.15 | 0.436 | |||
| VAS sleep post- | Mean ± SD | 1.44 ± 2.87 | 1.37 ± 2.76 | 1.59 ± 3.11 | 0.655 | |||
| Satisfaction post- | Mean ± SD | 7.89 ± 2.97 | 8.05 ± 2.87 | 7.57 ± 3.16 | 0.3573 | |||
| Super-responders | n (%) | 38 (18.81%) | 22 (16.42%) | 16 (23.53%) | 0.25443 | OR 0.638 (0.310–1.316) | ||
| Phenotype change | n (%) | 87 (43.07%) | 64 (47.76%) | 23 (33.82%) | 0.0818 | OR 1.79 (0.98–3.28) | ||
| Visits to ED post- | n (%) | 15 (7.43%) | 12 (8.96%) | 3 (4.41%) | 0.3789 | OR 2.13 (0.58–7.82) | ||
| Adverse events | Total | n (%) | 91 (45.05%) | 63 (47.01%) | 28 (41.18%) | 0.43062 | OR 1.27 (0.7–2.29) | |
| Mild | n (%) | 78 (38.61%) | 54 (40.30%) | 24 (35.30%) | 0.48997 | OR 1.24 (0.68–2.27) | ||
| Moderate | n (%) | 22 (10.89%) | 13 (9.70%) | 9 (13.24%) | 0.44614 | OR 0.7 (0.28–1.74) | ||
| Severe | n (%) | 2 (0.99%) | 0 (0.00%) | 2 (2.94%) | 0.11221 | OR 0.10 (0.01–2.09) | ||
| Incidence of treatment suspension | Total | n (%) | 58 (28.71%) | 30 (22.39%) | 28 (41.18%) | 0.00867* | OR 0.41 (0.22–0.77) | |
| Primary F. | n (%) | 17 (8.42%) | 10 (7.46%) | 7 (10.29%) | 0.6768 | OR 0.7(0.26–1.94) | ||
| Secondary F. | n (%) | 21 (10.40%) | 8 (5.97%) | 13 (19.12%) | 0.0081* | OR 0.27 (0.11–0.68) | ||
| Tolerance F. | n (%) | 20 (9.90%) | 14 (10.45%) | 6 (8.82%) | 0.9077 | OR 1.21 (0.44–3.29) | ||
| Patient D. | n (%) | 9 (4.45%) | 5 (3.73%) | 4 (5.88%) | 0.73432 | OR 0.62 (0.16–2.39) | ||
| Other | n (%) | 2 (0.99%) | 0 (0%) | 2 (2.94%) | 0.21378 | OR 0.10 (0.00–2.09) | ||
| Months of survival | Total | Mean ± SD | 22.54 ± 18.71 | 26.62 ± 20.18 | 14.51 ± 11.99 | 0.00001* | ||
| Suspended (Mean ± SD) |
All | 14.52 ± 14.14 | 16.5 ± 16.88 | 12.39 ± 10.34 | 0.26604 | |||
| Primary F. | 3.82 ± 1.81 | 4.60 ± 1.96 | 2.71 ± 0.76 | 0.01655* | ||||
| Secondary F. | 15.76 ± 8.95 | 17.25 ± 9.63 | 14.85 ± 8.77 | 0.57496 | ||||
| Tolerance F. | 11.25 ± 11.06 | 12.07 ± 12.4 | 9.33 ± 7.66 | 0.55675 | ||||
| Patient D. | 25.78 ± 24.15 | 39.0 ± 25.08 | 9.25 ± 7.80 | 0.05483 | ||||
| Ongoing | Mean ± SD | 25.78 ± 19.39 | 29.54 ± 20.18 | 16.00 ± 12.94 | 0.00001* | |||
Mean ± standard deviation is provided for continuous variables, and absolute numbers and/or percentages for categorical variables. Statistically significant comparisons are highlighted in bold (*). Some additional relevant results close to statistical significance are also highlighted in bold (without *). Odds ratios (OR) with 95% confidence intervals (CI) are provided where appropriate.