Table 1.
Efficacy of ruxolitinib cream 1.5% in patients aged ≥ 12 years with mild to moderate atopic dermatitis
| Treatment (no. of pts) | Responder rate [% of pts] (OR vs vehicle; 95% CI) | |||
|---|---|---|---|---|
| IGA-TSa | EASI75 | Itch NRSb | PROMIS 8b c | |
| TRuE-AD1 [17] | ||||
| RUX cream 1.5% (253) | 53.8** (7.5; 4.2–14.0) | 62.1** (5.2; 3.1–8.8) | 52.2** (6.0; 2.9–13.2) | 22.3* (2.7; 1.2–5.7) |
| Vehicle (126) | 15.1 | 24.6 | 15.4 | 9.5 |
| TRuE-AD2 [17] | ||||
| RUX cream 1.5% (228) | 51.3** (15.8; 7.4–38.1) | 61.8** (10.7; 5.8–20.7) | 50.7** (5.8; 2.8–12.7) | 25.6 (1.5; 0.8–2.7) |
| Vehicle (118) | 7.6 | 14.4 | 16.3 | 19.1 |
| Pooled analysis [25, 26] | ||||
| RUX cream 1.5% (481) | 52.6** | 62.0** | 51.5** | 23.8* |
| Vehicle (244) | 11.5 | 19.7 | 15.8 | 14.2 |
Primary and key secondary endpoint results at week 8 from two identically designed, multinational phase III studies [17] and a pooled analysis of these studies [25, 26]
BL baseline, EASI75 75% improvement from BL in Eczema Area and Severity Index score, IGA-TS Investigator’s Global Assessment treatment success, NRS Numerical Rating Scale, OR odds ratio, PROMIS 8b Patient-Reported Outcomes Measurement Information System short form sleep disturbance questionnaire, pts patients, RUX ruxolitinib
*p < 0.01, **p < 0.0001 vs vehicle
aPrimary endpoint; responders had an IGA score of 0 (clear) or 1 (almost clear) and a ≥ 2-point improvement from BL (scores range from 0–4; higher scores indicate greater severity)
bResponders had a clinically relevant ≥ 4-point improvement from BL in the Itch NRS [scores range from 0 (no itch) to 10 (worst imaginable itch)]. Assessed in pts with a BL itch NRS of ≥ 4 (in the RUX cream 1.5% and vehicle groups, respectively, n = 161 and 78 in TRuE-AD1, n = 154 and 81 in TRuE-AD2 and n = 307 and 158 in the pooled analysis)
cResponders had a clinically relevant ≥ 6-point improvement from BL in the PROMIS 8b score (scores range from 8–40; higher scores indicate a greater severity of sleep disturbance [39, 40]). Assessed in 238 and 116 pts in the RUX cream 1.5% and vehicle groups in TRuE-AD1, 211 and 110 pts in TRuE-AD2 and 449 and 226 pts in the pooled analysis