TABLE 2.
Effectiveness outcomes of Dupilumab after 16 weeks (T1) and after 32 weeks (T2): one‐way repeated measures ANOVA with post hoc tests and Friedman's test with Wilcoxon signed‐rank tests as post hoc tests
| Outcome variable | Baseline T0 | 16 weeks T1 | 32 weeks T2 | GLM Rep Meas/ Friedman test a | Post hoc test/ Wilcoxon signed‐rank test b | |
|---|---|---|---|---|---|---|
| T0/T1 | T1/T2 | |||||
| m ± SD/M(IQR) | m ± SD/M(IQR) | m ± SD/M(IQR) | p‐Value | p‐Value, r | p‐Value | |
| EASI | 26.7 ± 11.3 | 2.9 ± 3.7 | 2.6 ± 2.9 | <0.001 | <0.001, 0.91 | 0.461 |
| SCORAD | 62.2 ± 11.8 | 17.1 ± 11.8 | 14.8 ± 11.5 | <0.001 | <0.001, 0.95 | 0.080 |
| POEM | 22.0(16.0–25.0) | 5.0(2.0–11.0) | 5.0(2.0–11.0) | <0.001 | <0.001, 0.88 | 1.000 |
| DLQI | 15.9 ± 7.0 | 4.1 ± 4.4 | 3.9 ± 4.7 | <0.001 | <0.001, 0.86 | 0.802 |
| Itch‐NRS | 10.0(8.0–10.0) | 2.0(1.0–4.0) | 3.0(1.0–4.0) | <0.001 | <0.001, 0.92 | 0.483 |
| Sleep‐NRS | 8.0(5.0–10.0) | 0.0(0.0–1.7) | 0.0(0.0–0.0) | <0.001 | <0.001, 0.87 | 1.000 |
| HADS‐A | 7.0(5.0–11.0) | 5.0(3.0–7.0) | 4.0(2.0–7.0) | <0.001 | <0.001, 0.62 | 0.111 |
| HADS‐D | 6.0(3.0–9.0) | 3.0(2.0–6.0) | 3.0(1.0–6.0) | <0.001 | <0.001, 0.57 | 1.000 |
| SF‐36‐PF | 85.0(70.0–95.0) | 95.0(90.0–100.0) | 100.0(90.0–100.0) | <0.001 | <0.001, 0.57 | 0.459 |
| SF‐36‐RP | 50.0(0.0–75.0) | 100.0(75.0–100.0) | 100.0(75.0–100.0) | <0.001 | <0.001, 0.62 | 0.950 |
| SF‐36‐BP | 45.5(24.4–67.8) | 93.3(74.4–100.0) | 93.3(82.2–100.0) | <0.001 | <0.001, 0.79 | 0.819 |
| SF‐36‐GH | 48.2 ± 21.8 | 64.6 ± 20.2 | 65.4 ± 18.7 | <0.001 | <0.001, 0.62 | 0.591 |
| SF‐36‐V | 47.7 ± 17.4 | 63.6 ± 15.5 | 67.3 ± 15.5 | <0.001 | <0.001, 0.62 | 0.112 |
| SF‐36‐SF | 50.0(37.5–75.0) | 87.5(62.5–100.0) | 87.5(75.0–100.0) | <0.001 | <0.001, 0.73 | 0.787 |
| SF‐36‐RE | 33.3(0.0–100.0) | 100.0(100.0–100.0) | 100.0(100.0–100.0) | <0.001 | <0.001, 0.66 | 1.000 |
| SF‐36‐MH | 57.0 ± 20.2 | 73.1 ± 14.5 | 73.4 ± 16.4 | <0.001 | <0.001, 0.62 | 1.000 |
| Adv. event | n (%) | n (%) | n (%) | Bring to discontinuation, n (%) | ||
| IS reaction | / | 2(1.2) | / | |||
| Herpes | / | 6(3.6) | / | |||
| Blef./Conj. | / | 18(10.7) | 19(11.2) | 4(2.3) | ||
| Cephalea | / | 5(3.0) | / | |||
| Itchy eye | / | 11(6.5) | / | |||
| To report | ||||||
| Ineffectiveness | 3(1.7) | |||||
| Pregnancy | 3(1.7) | |||||
| Bladder cancer | 1(0.6) | |||||
| Arthromyalgia | 1(0.6) | |||||
| Skin rashes | 1(0.6) | |||||
Abbreviations: Adv. event, adverse event; Blef./Conj., blepharitis or conjunctivitis; DLQI, Dermatology Life Quality Index; EASI, Eczema Area and Severity Index; HADS‐A, Hospital Anxiety and Depression Scale—Anxiety subscale; HADS‐D, Hospital Anxiety and Depression Scale—Depression subscale; IS reaction, Reaction to the injection site; Itch‐NRS, Numerical Rating Scale for itch; m ± SD/M(IQR), mean ± standard deviation/median (interquartile range); POEM, Patient Oriented Eczema Measure; r, effect size; SCORAD, SCOring Atopic Dermatitis index; SF‐36‐BP, Short Form Health Survey—bodily pain subscale; SF‐36‐GH, Short Form Health Survey—general health subscale; SF‐36‐MH, Short Form Health Survey—mental health subscale; SF‐36‐PF, Short Form Health Survey—physical functioning subscale; SF‐36‐RE, Short Form Health Survey—role emotional subscale; SF‐36‐RP, Short Form Health Survey—role physical subscale; SF‐36‐SF, Short Form Health Survey—social functioning subscale; SF‐36‐V, Short Form Health Survey—vitality subscale; Sleep‐NRS, Numerical Rating Scale for sleep disorders.
P value of one‐way repeated measure ANOVA model or Friedman's test.
Post hoc test for one‐way repeated measure ANOVA or Wilcoxon signed‐rank test as post hoc test for Friedman's test (Bonferroni correction with alpha set at 0.017).