Ruxolitinib Cream Improves AD Across Body Regions, Shows Efficacy, Safety in Black Patients

Findings of 2 abstracts presented at the 2022 American Academy of Dermatology (AAD) Annual Meeting showed that ruxolitinib cream (​​Opzelura) demonstrated significant improvements vs vehicle (nonmedicated cream) in patients with atopic dermatitis (AD) of Black race and across anatomic regions.

In the management of AD, disease-related lesions in Black patients have decreased expression of Th1 and Th17 markers compared with European Americans, suggesting molecular differences in AD pathogenesis by race.

Investigators sought to explore whether the efficacy and safety shown prior in the TRuE-AD1 (NCT03745638) and TRuE-AD2 (NCT0374651) phase 3 studies evaluating ruxolitinib cream, a topical selective inhibitor of Janus kinase (JAK) 1 and JAK2, would be achieved when stratifying for Black race.¹ Approximately 23.4% of the 1249 patients included in the studies were identified to be Black.

“Black children are approximately 2 times more likely than White children to receive an AD diagnosis and are also more likely to have severe AD compared with White children,” noted the abstract authors. “Black patients report poorer disease control, more frequent skin infections, and a greater financial burden compared with non-Black patients with AD.”

The safety and efficacy of ruxolitinib cream was examined in 292 Black patients aged 12 and older of the TRuE-AD1 and TRuE-AD2 studies over 8 weeks, with additional analyses assessing for safety and disease control over 52 weeks in 170 patients. Included patients had an Investigator’s Global Assessment (IGA) score of 2 or 3 and 3%-20% affected body surface area (BSA), excluding scalp.

Efficacy and safety measures during the vehicle-controlled (VC) period included the proportion of patients achieving IGA treatment success (IGA-TS, IGA score of 0 or 1 and greater than or equal to 2-point improvement from baseline), the proportion of patients with a greater than or equal to 75% improvement in Eczema Area and Severity Index (EASI‑75), and the proportion of patients achieving a greater than or equal to 4-point improvement in itch numerical rating scale (itch NRS4).

Disease control was assessed by the proportion of patients with no or minimal skin lesions (IGA score of 0 or 1 [clear or almost clear skin]) and mean percentage of BSA affected by AD at each visit (every 4 weeks) during the long-term safety (LTS) period.

Safety and tolerability assessments during the VC period and throughout the 52-week study period included the frequency of reported treatment-emergent adverse events (AEs), treatment-related AEs, serious AEs, and frequency of AEs leading to treatment discontinuation.

Of the study cohort, 61 were randomized to vehicle cream and 118 and 113 patients were randomized to 0.75% and 1.5% ruxolitinb cream, respectively.

Findings during the VC period showed that significantly more Black patients given ruxolitinb cream vs vehicle achieved IGA-TS, EASI-75, and itch NRS4 after 8 weeks, with the drug indicated to be well tolerated.

The LTS period further showed significant efficacy and adequate safety for those given ruxolitinb cream vs vehicle:

• For patients who continued on 0.75% or 1.5% ruxolitinib cream from the VC period, 53.8% and 61.9% had clear or almost clear skin (IGA 0/1) at week 8, respectively; 70.1% and 70.0% had clear or almost clear skin at week 52
• For patients who switched from vehicle to 0.75% or 1.5% ruxolitinib cream at the start of the LTS, 36.0% and 18.2% had clear or almost clear skin at week 8, respectively; 76.5% and 66.7% had clear or almost clear skin at week 52
• For patients who continued on 0.75% or 1.5% ruxolitinib cream from the VC period, mean affected BSA was 3.8% and 3.6% at Week 8, respectively, and 1.7% and 1.6% at week 52
• For patients who switched from vehicle to 0.75% or 1.5% ruxolitinib cream at the start of the LTS, mean affected BSA was 5.2% and 6.4% at week 8, respectively, and 1.6% for both at week 52

“Although differences were observed in baseline disease characteristics and efficacy in the VC period compared with the overall study population, Black or African American patients who continued in the LTS period exhibited similar safety and disease control as the overall population,” concluded researchers.

Another abstract using pooled data of the TRuE-AD1 and TRuE-AD2 studies examined the efficacy and safety of ruxolitinib cream for the treatment of AD by anatomic region.²

A total of 1208 patients with AD were examined via the mean percentage reductions from baseline in EASI subscores by body region (head/neck, trunk, upper limbs, lower limbs) and signs of AD (induration/papulation/edema, erythema, excoriations, lichenification) at weeks 2, 4, and 8.

“Distribution pattern of disease may be affected by exposure to different triggering factors, and anatomic location of lesions may affect treatment options,” noted researchers.

Of the study cohort, 244 were randomized to vehicle cream and 483 and 481 patients were randomized to 0.75% and 1.5% ruxolitinb cream, respectively.

Results showed significant improvements in induration/papulation/edema, erythema, excoriations, and lichenification across anatomic regions with 0.75% and 1.5% ruxolitinib cream vs vehicle as early as week 2, which continued to improve through week 8. Regardless of lesion location, ruxolitinib cream was well tolerated.

“During the VC period, treatment-emergent AEs were reported by 145/500 (29.0%), 132/499 (26.5%), and 83/250 (33.2%) patients in the 0.75% ruxolitinib cream, 1.5% ruxolitinib cream, and vehicle groups, respectively.”

References

1. Eichenfield LF, Stein Gold LF, Chiesa Fuxench ZC, Venturanza ME, Brar KK. Safety and efficacy over 8 weeks and disease control over 52 weeks with ruxolitinib cream among Black or African American patients with atopic dermatitis: Pooled results from two phase 3 studies. Presented at: 2022 American Academy of Dermatology Annual Meeting. Abstract: 34794.

2. Simpson EL, Bissonnette R, Stein Gold LF, Chiesa Fuxench ZC, Venturanza ME, Silverberg JI. Efficacy of ruxolitinib cream for the treatment of atopic dermatitis by anatomic region: Pooled analysis from two randomized phase 3 studies. Presented at: 2022 American Academy of Dermatology Annual Meeting. Abstract: 34587.