Emphasis on the safety of ruxolitinib/ruxolitinib cream in combination regimens

Management of moderate to severe atopic dermatitis (AD)usually requires systemic therapy, but topical therapy remains essential, often as part of a combination treatment regimen. TopicalJAK1/2 inhibitors Ruxolitinib/ruxolitinib cream 1.5% cream is currently approved as monotherapy for mild to moderate AD, and the label warns against concurrent use of systemic medications.

A recent multicenter retrospective study, presented as a poster at the 2025 Revolutionizing Atopic Dermatitis (RAD) Conference in Nashville, Tennessee, was designed to evaluate the real-world safety and clinical outcomes of long-term RUX 1.5% cream when combined with systemic treatment of AD. Researchers analyzed data from 115 AD patients and observed that the vast majority of patients did not experience treatment-related adverse events (AEs), and the reported adverse events were apparently mild and rare. Crucially, no serious adverse events, including malignancy, serious infection, or death, were observed. Efficacy evaluation at week 52 showed significant improvements in Investigator Global Assessment (IGA), body surface area (BSA) and pruritus scores in both cohorts. These compelling findings suggest that, despite current labeling restrictions, combining RUX 1.5% cream with systemic medications may be a safe and effective strategy for the treatment of refractory moderate to severe AD and warrants further prospective study.

A multicenter retrospective analysis was conducted to provide real-world insights into the safety and clinical outcomes of long-term useRUX 1.5% Cream in combination with systemic therapy for the treatment of atopic dermatitis. The researchers aim to inform clinical decision-making by bridging the gap between current labeling and actual patient management needs.

The study involved a meticulous multicenter retrospective chart review, includingdata from 115 AD patients treated with RUX 1.5% cream and systemic medications. Patients were divided into 2 distinct cohorts: Cohort A (n=73) consisted of patients who started on 1.5% RUX cream and subsequently added systemic therapy, reflecting an escalation of therapy. Cohort B (n=42) included patients who initiated RUX 1.5% cream while already on systemic therapy, representing an adjunctive use. Comprehensive data extraction included patient demographics, baseline disease characteristics, concomitant systemic therapies, observed adverse events (AEs), efficacy outcomes (investigator global assessment [IGA], body surface area [BSA], and patient-reported pruritus score), as well as detailed information on treatment discontinuations and their reasons.

As for safety, researchers said the vast majority of patients experienced no adverse events. Specifically, QueueNo adverse events were reported by 97.3% (71/73) of patients in cohort a and 87.8% (37/42) of patients in cohort B. The few adverse events observed were mild and rare, including only 1 (2.9%) injection site reaction with dolbumab. Other uncommon adverse events included acne (1.5% Cohort A), eyelid dermatitis (1.5% Cohort B), central retinal vein occlusion (1.5% Cohort C), and vision changes (1.5% Cohort D). Importantly, no cases of malignancy, serious infection, or death were reported in either cohort, which is clinically reassuring. Additionally, no new safety signals emerged that have not been documented in the established safety profile of ruxolitinib monotherapy. This finding strongly suggests that combination treatment with RUX cream does not pose unforeseen safety risks.

Week 52 efficacy resultswere convincing and demonstrated substantial improvements in key clinical measures. In cohort A, the mean changes from baseline were impressive: IGA -2.57±0.54, BSA -8.03±2.17, pruritus score -8.04±0.37. Cohort B also showed significant improvement, with mean changes in IGA of -2.38±0.54, BSA of -22.62±4.94, and pruritus score of -6.18±0.27. These efficacy data highlight the clinical benefits that this combination approach can achieve in the real world.

In CohortThe discontinuation rate of ruxolitinib was 13.7% (10/73) in Cohort A and 26.8% (11/42) in Cohort B. Reasons for discontinuation varied and included ineffectiveness (1.5% Cohort A, 2.0% Cohort B), disease flare (1.5% Cohort B, 2.9% Cohort A), secondary failure (2.9% Cohort A, 1.0% Cohort B), coverage issues (1.5% Cohort C, 1.0% Cohort C), and AD clearance (1.5% Cohort D). A significant proportion was due to other undefined causes (5.5% in cohort A, 3.8% in cohort B), as is often seen in retrospective analyses.

In summary, this real-world analysis provides compelling evidence that RUX 1.5% Cream has a favorable safety profile when administered in combination with systemic therapy for AD, characterized by mild and rare adverse events and no new safety signals emerged. More importantly, the study revealed significant improvements in key disease activity indicators, reinforcing the clinical utility of this combination strategy. These findings advocate thoughtful integration of RUX 1.5% Cream into selected combination treatment regimens for patients with refractory moderate to severe AD, providing a safe and effective treatment option.

Reference materials:https://www.dermatologytimes.com/view/rad-2025-poster-highlights-ruxolitinib-cream-safety-in-combination-ad-regimens