Ruxolitinib Cream Shows Long-Term Disease Control, Efficacy Among Adolescents with Eczema

Lawrence Eichenfield, MD

Credit: Rady Children's Hospital

Ruxolitinib cream, 1.5% may result in significant antipruritic and anti-inflammatory effects within the subset of adolescent patients with atopic dermatitis, according to new findings, and long-term, as-needed utilization of the drug is well tolerated and maintains disease control.¹

These conclusions resulted from a new study looking at long-term disease control, safety, and efficacy of the topical Janus kinase (JAK) 1/JAK2 inhibitor, specifically highlighting the cream’s impact on adolescent eczema patients aged 12–17 years. Data was drawn from the pooled TRuE-AD1 and TRuE-AD2 phase 3 studies for the study.

This research was led by Lawrence Eichenfield, MD, of Rady Children’s Hospital and the departments of dermatology and pediatrics at the University of California, San Diego. Eichenfield and colleagues noted that over the 8-week course of the 2 studies’ vehicle-controlled and the 44-week long-term safety periods, the general population of both adolescents and adults saw positive results.²

“Here we report the safety and efficacy of 1.5% ruxolitinib cream (the approved formulation strength in the USA) versus vehicle through week 8 and long-term disease control with 1.5% ruxolitinib cream monotherapy through week 52 in a subset of adolescents using pooled data from the two phase 3 studies,” Eichenfield et al. wrote.

Background and Methods

The research team looked at data drawn from the TRuE-AD1 and TRuE-AD2 studies, which had been done in 10 North American and European countries and involved participants aged 12 years and older with atopic dermatitis, 3–20% body surface area (BSA) excluding the scalp, and an Investigator’s Global Assessment (IGA) score of either 2 or 3.

Those involved in the study were randomized (2:2:1) to either be given topical ruxolitinib at 0.75% or 1.5% with a twice-per-day regimen, or a vehicle cream bid over an 8-week course of the double-blinded period of treatment. Following the 8-week mark, those given ruxolitinib had been continually treated for 44 further weeks and those first on vehicle were then rerandomized to the drug.

The research team assessed efficacy during their research, looking at IGA treatment success, severity in pruritus, Eczema Area Severity Index (EASI) score improvement, quality of life (QoL), and sleep-related impairment.

The team assessed adverse events (AEs) which were potentially connected to ruxolitinib cream, including malignancies, serious infections, cardiovascular events, and liver enzyme elevations. The investigators also focused on disease control over the course of the long-term safety (LTS) period.

Findings

The study involved 1249 total participants, with 19.6% having been in the age range of 12–17 years, 45 in the vehicle arm and 92 in the ruxolitinib arm. The investigators found that in the LTS period of their research, 75.9% of the subjects continued on ruxolitinib cream and 79.8% finished out this period.

They also noted that by the 8-week mark, a gar greater number of participants using topical ruxolitinib were shown to have achieved improved IGA-TS (50.6% compared to 14.0%), NRS4 (52.1% compared to 17.4%) and EASI-75 (60.9% compared to 34.9%). There was also a notable shift in itch NRS scores for those given ruxolitinib cream versus vehicle from the second day onward.

The research team commented that in the LTS period, there was a safe range of subjects’ steady-state ruxolitinib plasma concentrations, adding that the percentage of individuals involved in the reseach with improved scores was found to be sustained or even increase. They lastly noted the rarity of application site reactions, with 1.8% of adolescents on the drug, and found no serious infections, adverse events, malignancies, or major cardiovascular events over the 52 week course of the study.

“A limitation of this study was the relatively low number of adolescent patients compared with the overall study population and the low number of Asian patients overall, so results may not be broadly generalizable,” they wrote. “Another limitation is that application site reactions by body region were only partially captured.”

References

1. ^{Eichenfield, L.F., Simpson, E.L., Papp, K. et al. Efficacy, Safety, and Long-Term Disease Control of Ruxolitinib Cream Among Adolescents with Atopic Dermatitis: Pooled Results from Two Randomized Phase 3 Studies. Am J Clin Dermatol (2024). https://doi.org/10.1007/s40257-024-00855-2.}
2. ^{Papp K, Szepietowski JC, Kircik L, Toth D, Eichenfield LF, Forman SB, et al. Long-term safety and disease control with ruxolitinib cream in atopic dermatitis: results from two phase 3 studies. J Am Acad Dermatol. 2023;88(5):1008–16.}