Ruxolitinib Cream Improves Atopic Dermatitis Pain, Anxiety and Depression Over 52 Weeks

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New long-term phase 3 data show adults and adolescents both improved measures of quality of life when treated with either of 2 doses of ruxolitinib cream.

Topical JAK inhibitor ruxolitinib cream was associated with substantial improvements in patients’ skin-related quality of life, pain symptoms, and mental health and wellbeing across both adolescents and adults with atopic dermatitis.

New findings presented at the Society of Dermatology Physician Assistants (SDPA) 2022 Annual Meeting in Miami, FL last week showed that patients reported improvements in not only signs and symptoms of atopic dermatitis when treated with ruxolitinib cream over 52 weeks, but additionally improvements in anxiety and depression scoring.

Led by Eric L. Simpson, MD, a group of US investigators sought to define the impact of long-term as-needed ruxolitinib cream treatment on patient-reported quality of life using pooled data from the phase 3 TRuE-AD clinical trial program assessing the JAK inhibitor in adolescent and adult patients with atopic dermatitis.

The assessment included patients aged 12 years and older with atopic dermatitis for at least 2 years who had a baseline Investigator's Global Assessment (IGA) score of 2 or 3 , as well as an affected body surface area (BSA) of 3% to 20%.

The TRuE-AD 1 and 2 clinical trial program included patients who were randomized to 2:1 to either of two ruxolitinib cream strength regimens of 0.75% or 1.5% twice-daily, or vehicle cream twice-daily for 8 weeks. Both trials were double-blinded continuous treatment assessments in which patients were encouraged to continue treating their lesions even after improvement through treatment.

Afterward, patients continued in a double-blind, long-term safety assessment through up to 52 weeks. Investigators collected pooled data from the trial program to interpret quality-of-life, pain symptoms and mental wellbeing outcomes among adolescents and adults treated with ruxolitinib cream.

Simpson and colleagues assessed skin-related quality of life scores via the Dermatology life Quality Index (DLQI) for patients aged 16 years and older, and Children's Dermatology Quality of Life (CDLQI).  Investigators additionally assessed patient skin pain and discomfort, as well as anxiety and depression via the EuroQoL 5-Dimension 5-Levels (EQ-5D-5L) questionnaire.

Their final assessment included 1031 total patients receiving either ruxolitinib cream 0.75% (n = 409), 1.5% (n = 428), vehicle then 0.75% (n = 98), or vehicle then 1.5% (n = 96). Mean patient age was 33.0 years old; 61.7% of patients were female. Mean BSA was 9.7% at baseline, and median duration of atopic dermatitis was 15.1 years.

Mean DLQI score was 9.6; CDLQI score was 8.2, and Itch NRS score was 5.1.

Each of the 4 treatment arms achieved a significant improvement in DLQI from baseline to week 52:

  • 0.75% ruxolitinib: -7.8
  • 1.5% ruxolitinib: -7.5
  • Vehicle to 0.75% ruxolitinib: -6.9
  • Vehicle to 1.5% ruxolitinib: -7.4

Approximately two-thirds of treated patients achieved a DLQI score of 0 or 1 by week 52 with ruxolitinib cream:

  • 0.75% ruxolitinib: 62.6%
  • 1.5% ruxolitinib: 60.7%
  • Vehicle to 0.75% ruxolitinib: 61.9%
  • Vehicle to 1.5% ruxolitinib: 68.2%

Investigators similarly observed improvements per CDLQI from baseline, as well as proportion of patients to achieve scores of 0 or 1 at week 52.

Regarding measures of skin pain per EQ-5D-5L, investigators observed that more patients who were initiated in either ruxolitinib group reported no skin pain or discomfort compared to patients receiving vehicle or control at week 8. By week 52, ≥63% of each treatment arm had achieved such an outcome.

In measures of anxiety or depression per EQ-5D-5L, investigators observed that ≥72.% of each treatment arm achieved measures of no anxiety nor depression by week 52.

The team noted that 677 (63.2%) patients who applied ruxolitinib cream experienced a treatment-emergent adverse event (TEAE). The most common TEAEs were upper respiratory tract infections (10.1%) and nasopharyngitis (9.7%).

Simpson and colleagues concluded that ruxolitinib cream provided both adolescents and adults with atopic dermatitis significant improvements to their skin-related quality of life, measures of pain and mental health through 52 weeks of therapy.

“Patients who switched from vehicle cream to ruxolitinib cream…had similar improvements in quality of life at week 52 compared to patients initially randomized to ruxolitinib cream,” they wrote.

The study, “Effects of Ruxolitinib Cream on Patient-Reported Quality of Life in Atopic Dermatitis: 52-Week Pooled Results From Phase 3 Studies,” was presented at SDPA 2022.