Table 1.
Summary of Efficacy Outcomes for Ruxolitinib 1.5% Cream BID vs Vehicle BID (if Applicable) at Week 8 in Phase I–III Studies
IGA-TS (%)a | EASI-75 (%)b | NRS4 (%)c | % Reduction in EASI | % Reduction in Itch NRS | |
---|---|---|---|---|---|
Phase I | |||||
Ruxolitinib 1.5% (n=41) | 56.8 | 94.6 | 90.5 | − 93.75 | N/A |
Phase II | |||||
Ruxolitinib 1.5% (n=50) | 48.0* | N/A | N/A | − 78.5* | − 68.5** |
Vehicle (n=52) | 9.6 | N/A | N/A | − 26.9 | − 17.6 |
Phase III (TRuE-AD1) | |||||
Ruxolitinib 1.5% (n=253) | 53.8** | 62.1** | 52.2** | − 77.2** | − 67.3** |
Vehicle (n=126) | 15.1 | 24.6 | 15.4 | − 40.5 | − 35.3 |
Phase III (TRuE-AD2) | |||||
Ruxolitinib 1.5% (n=228) | 51.3** | 61.8** | 50.7** | − 74.7** | − 62.0** |
Vehicle (n=118) | 7.6 | 14.4 | 16.3 | − 28.9 | − 32.1 |
Notes: *p<0.001 vs vehicle, **p<0.0001 vs vehicle. aProportion of patients who achieved IGA treatment success, defined as IGA score of 0/1 with a ≥2-grade improvement from baseline, bProportion of patients with a ≥75% improvement in the Eczema Area and Severity Index, cProportion of patients with a ≥4-point improvement in the itch Numerical Rating Scale score.
Abbreviations: BID, twice daily; EASI, Eczema Area and Severity Index; IGA-TS, Investigator’s Global Assessment – Treatment Success; N/A, not applicable; NRS, Numerical Rating Scale; TRuE-AD1, Topical Ruxolitinib Evaluation in Atopic Dermatitis Study 1; TRuE-AD2, Topical Ruxolitinib Evaluation in Atopic Dermatitis Study 2.