A recent multi-center retrospective study presented at the 2025 Revolutionizing Atopic Dermatitis (RAD) meeting in Nashville provides new insights into the safety and effectiveness of combining Ruxolitinib (RUX) 1.5% cream with systemic therapies for the treatment of moderate to severe atopic dermatitis (AD). The study, which reviewed data from 115 AD patients, found that the combination of RUX cream with systemic treatments was not only safe but also led to significant improvements in disease outcomes, including reduced disease severity and itch.
Ruxolitinib, a topical JAK1/2 inhibitor, is already approved for treating mild to moderate AD as a monotherapy. However, its combination with systemic therapies has not been widely studied in clinical practice due to concerns about potential safety risks. The recent analysis, however, suggests that the use of RUX 1.5% cream in combination with systemic agents does not introduce any new or serious adverse events. Most patients in the study experienced no treatment-related side effects, and those who did report side effects experienced only mild and infrequent reactions, such as minor skin issues or vision changes. Importantly, there were no cases of serious infections, malignancy, or death associated with the treatment.
The study divided patients into two cohorts. Cohort A consisted of patients who started RUX 1.5% cream and later added systemic treatment, while Cohort B included patients who were already on systemic therapy when they began using RUX cream. The average duration of combined treatment for patients in Cohort A was 16.8 months, while patients in Cohort B were treated for an average of 21 months.
In terms of efficacy, the results were encouraging. Patients in both cohorts showed substantial improvements in key disease markers by week 52. Cohort A had a mean change in Investigator Global Assessment (IGA) of -2.57, a decrease in Body Surface Area (BSA) of -8.03, and a reduction in itch score of -8.04. Similarly, Cohort B showed a decrease in IGA of -2.38, BSA of -22.62, and itch score of -6.18. These significant improvements demonstrate the potential of RUX cream in combination with systemic therapies to provide meaningful relief for patients with refractory AD.
While the study’s findings suggest a positive real-world application of combining RUX 1.5% cream with systemic agents, the treatment also had a discontinuation rate of 13.7% in Cohort A and 26.8% in Cohort B. The reasons for discontinuation varied, with some patients discontinuing due to disease flare-ups, lack of efficacy, or insurance-related issues.
The results of this study offer important insights into how RUX 1.5% cream could be effectively integrated into treatment regimens for patients with moderate to severe AD. While these findings challenge current labeling, which limits RUX use to monotherapy, they highlight the need for further research and prospective studies to explore the long-term safety and efficacy of this combination approach. Such studies could potentially lead to updates in clinical guidelines and expanded treatment options for patients suffering from chronic AD.
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