INTRODUCTION
Atopic dermatitis (AD) is a highly pruritic, chronic inflammatory skin disease.1 Although topical corticosteroids are the mainstay of therapy in patients with mild to moderate AD, a need for alternative nonsteroidal therapies has led to the development of novel therapeutic agents.2 Janus kinases (JAKs) act downstream of key proinflammatory cytokines that promote AD pathogenesis.3 In a phase 2 dose-ranging study (NCT03011892), ruxolitinib (JAK1/JAK2 inhibitor) cream demonstrated greater improvement in AD signs and symptoms versus vehicle and an active comparator (0.1% triamcinolone cream).4,5 With the subsequent approval of ruxolitinib cream in patients with mild to moderate AD,6 there is renewed interest in comparative efficacy and safety data of nonsteroidal topical therapies versus topical corticosteroids routinely used in clinical practice; these comparative data are often lacking in clinical studies. Here, we present comparative analyses of outcomes among patients who applied 1.5% ruxolitinib cream twice daily (BID), 0.1% triamcinolone cream BID, and vehicle using data from the 4-week vehicle- and active-controlled period of the phase 2 study.
MATERIALS AND METHODS
Patients and Study Design
Eligible patients were aged 18 to 70 years, had active AD with a greater than or equal to 2-year history, an Investigator’s Global Assessment (IGA) score of 2/3, and an affected body surface area of 3% to 20%. Additional information regarding the patient population and study design has been previously published.4 Patients were equally randomized to vehicle cream BID, active control (0.1% triamcinolone cream BID for 4 weeks followed by vehicle BID for 4 weeks), or a ruxolitinib cream regimen (0.15% once daily [QD], 0.5% QD, 1.5% QD, or 1.5% BID) for 8 weeks of double-blind monotherapy treatment. This descriptive analysis includes data up to week 4 from patients randomized to vehicle BID, 0.1% triamcinolone BID, or 1.5% ruxolitinib cream BID to compare efficacy outcomes and summarize safety data.
Assessments
The primary endpoint was the mean percentage change from baseline in Eczema Area and Severity Index (EASI) score with 1.5% ruxolitinib cream versus vehicle at week 4. Secondary efficacy endpoints included in this analysis were the proportion
Eligible patients were aged 18 to 70 years, had active AD with a greater than or equal to 2-year history, an Investigator’s Global Assessment (IGA) score of 2/3, and an affected body surface area of 3% to 20%. Additional information regarding the patient population and study design has been previously published.4 Patients were equally randomized to vehicle cream BID, active control (0.1% triamcinolone cream BID for 4 weeks followed by vehicle BID for 4 weeks), or a ruxolitinib cream regimen (0.15% once daily [QD], 0.5% QD, 1.5% QD, or 1.5% BID) for 8 weeks of double-blind monotherapy treatment. This descriptive analysis includes data up to week 4 from patients randomized to vehicle BID, 0.1% triamcinolone BID, or 1.5% ruxolitinib cream BID to compare efficacy outcomes and summarize safety data.
Assessments
The primary endpoint was the mean percentage change from baseline in Eczema Area and Severity Index (EASI) score with 1.5% ruxolitinib cream versus vehicle at week 4. Secondary efficacy endpoints included in this analysis were the proportion