Incyte’s ruxolitinib cream showed disease maintenance and symptom control with as-needed use over a 44-week period in adolescents and adults with atopic dermatitis (AD), according to a poster presentation at the 2023 American Academy of Dermatology (AAD) Annual Meeting in New Orleans, Louisianna.1 In the phase 3 TruE-AD1 (NCT03745638) and TRuE-AD2 (NCT03745651) trials, ruxolitinib cream demonstrated anti-inflammatory results, with antipruritic action and significant improvement in itch and sleep compared to vehicle, and was well tolerated during the 8-week vehicle-controlled period in patients with AD. The 44-week long-term safety (LTS) period further proved ruxolitinib cream effectively controlled symptoms such as itch and sleep disturbance when used as needed.
Study authors investigated the long-term maintenance of disease and symptom control in adult and adolescent patients with AD applying ruxolitinib cream as needed by using pooled LTS data. Patients eligible for the studies were aged ≥12 years with AD for ≥2 years and had an Investigator’s Global Assessment (IGA) score of 2 or 3 and 3%–20% affected body surface area, excluding the scalp. In both studies, patients were randomized 2:2:1 to receive 0.75% twice daily ruxolitinib cream, 1.5% twice daily ruxolitinib cream, or vehicle cream.
Key study assessments include:
- The percentage of patients who achieved an IGA score of 0 (clear) or 1 (almost clear) or a score ≥2 (2, mild; 3, moderate; 4, severe) was assessed at baseline and every 4 weeks during the LTS period
- Itch was assessed by the percentage of patients reporting 0, 1 of itch per question 1 of the Patient-Oriented Eczema Measure (POEM Q1) at weeks 8, 12, 24, and 52
- Sleep disturbance was assessed by the percentage of patients reporting 0, 1 2, or ≥3 nights of sleep disturbance per question 2 of the POEM Q2 at weeks 8, 12, 24, and 52
- Safety and tolerability assessments included frequency of treatment emergent adverse events (AEs), treatment-related AEs, serious AEs, and AEs leading to treatment discontinuation
Out of 1249 randomized patients, 1072 (85.8%) continued in the LTS period and 837 patients (67.0%) who applied ruxolitinib cream since day 1 were evaluated for disease and symptom control in the LTS period (0.75% ruxolitinib cream, n=409; 1.5% ruxolitinib cream, n=428). Approximately 75% of patients completed the LTS period, 11 patients (1.3%) discontinued treatment due to AEs, and 15 patients (1.8%) discontinued treatment due to lack of improvement.
Additional results include:
- The mean cumulative number of days with no treatment due to lesion clearance was 116.5 (85.9) and 133.8 (89.8) days with 0.75% ruxolitinib cream and 1.5% ruxolitinib cream, respectively
- The percentage of patients who applied 0.75%/1.5% ruxolitinib cream and achieved IGA 0/1 was 61.8%/67.1% at week 8 and 76.8%/77.8% at week 52
- 80%–90% of patients maintained or improved their IGA response between each visit
- Patients applying 0.75%/1.5% ruxolitinib cream achieved IGA 0/1 for a mean (95% CI) of 68.3% (65.0%, 71.6%; n=396)/73.6% (70.6%, 76.7%; n=414) of all visits, respectively, among those with ≥1 visit in the LTS period, and 69.1% (65.9%, 72.4%; n=384)/73.5% (70.4%, 76.5%; n=400) among those with ≥2 visits in the LTS period
- Itch for 0 days in the past week was reported in 27.7%/32.7% of patients applying 0.75%/1.5% ruxolitinib cream at week 8 and in 28.0%/36.2% at week 52
- Sleep disturbance for 0 days in the past week was reported in 64.9%/71.8% of patients applying 0.75%/1.5% ruxolitinib cream at week 8 and in 74.5%/74.5% at week 52
Regarding safety, the study authors concluded, “Ruxolitinib cream was well tolerated during the 52-week study, confirming 8-week vehicle-controlled data.”
- Blauvelt A, Kircik L, Simpson E, et al. Ruxolitinib cream demonstrates maintenance of disease and symptom control with as-needed use in adults and adolescents with atopic dermatitis: Pooled analysis from the long-term safety periods of two phase 3 studies. Presented at the 2023 American Academy of Dermatology Annual Meeting; March 17-21, 2023; New Orleans, LA. Accessed March 17, 2023. https://aad-eposters.s3.amazonaws.com/AM2023/poster/44103/Ruxolitinib+Cream+Monotherapy+Use+Demonstrates+Maintenance+of+Disease+and+Symptom+Control+With+Use+As+Needed+in+Adults+and+Adolescents+With+Atopic+Dermatitis+Pooled+Analysis+From+the+Long+Term+Safety+Periods+of+Two+Phase+3+Studies.pdf