A recent multi-center retrospective study presented at the 2025 Revolutionizing Atopic Dermatitis (RAD) meeting in Nashville, Tennessee, has provided new insights into the real-world safety and efficacy of combining ruxolitinib (RUX) 1.5% cream with systemic therapies for the management of refractory moderate to severe atopic dermatitis (AD).
Background and Study Rationale
While systemic therapies are often required for moderate to severe AD, topical treatments like ruxolitinib 1.5% cream—a JAK1/2 inhibitor—remain essential, especially in combination regimens. Currently approved for mild to moderate AD as monotherapy, ruxolitinib cream’s labeling advises against concurrent use with systemic agents. This study aimed to assess the safety and clinical outcomes of long-term ruxolitinib cream when integrated with systemic therapies in real-world settings.
Study Methods
The study involved a retrospective chart review of 115 AD patients who used ruxolitinib 1.5% cream alongside systemic therapies between February 1, 2022, and January 1, 2023. Patients were divided into two cohorts: Cohort A (n=73) included those who started ruxolitinib cream before adding a systemic therapy, while Cohort B (n=42) included those who initiated ruxolitinib cream while already on systemic therapy. Data collected included demographics, baseline disease characteristics, adverse events (AEs), and efficacy outcomes measured by Investigator Global Assessment (IGA), Body Surface Area (BSA), and itch scores.
Results
The study found that the vast majority of patients experienced no treatment-related adverse events. Specifically, 97.3% of patients in Cohort A and 87.8% in Cohort B reported no AEs. The few AEs observed were mild and infrequent, with no serious AEs such as malignancy, serious infections, or death reported. Efficacy assessments at week 52 showed significant improvements in IGA, BSA, and itch scores across both cohorts, indicating substantial clinical benefit from the combination therapy.
Conclusion
The findings suggest that combining ruxolitinib 1.5% cream with systemic therapies is safe and effective for managing refractory moderate to severe AD, despite current labeling limitations. The study highlights the potential for this combination strategy to improve clinical outcomes while maintaining a favorable safety profile. While these real-world results are promising, further prospective studies are needed to fully characterize the long-term safety and efficacy of this approach.
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