Overall, acne events were mild or moderate and did not cause patients to discontinue ruxolitinib cream treatment.
A recent presentation from the European Academy of Dermatology and Venereology Congress 2023 in Berlin, Germany, analyzed the characterization and treatment of acne related to patients who applied ruxolitinib cream for the treatment of vitiligo in TRuE-V1 and TRuE-V2. Rosmarin et al found that all acne events that occurred during ruxolitinib cream treatment for vitiligo were mild or moderate in severity and were not considered serious. Acne events after ruxolitinib treatment mostly occurred in adults and those without a history of acne. The authors noted that this suggests that ruxolitinib treatment-related acne may not be classical acne. No patients discontinued ruxolitinib cream treatment due to acne, and only 1 patient interrupted treatment due to acne.1
It is important to note that acne is a commonly reported adverse reaction with JAK inhibitor treatment and does not suggest the inefficacy of ruxolitinib or other JAKs.2
In TRuE-V1 (NCT04052425) and TRuE-V2 (NCT04057573), approximately 50% of patients applying ruxolitinib cream throughout had ≥75% improvement in facial Vitiligo Area Scoring Index (VASI) at week 52. Ruxolitinib cream was generally well tolerated over 52 weeks, with application site acne being the most commonly reported adverse event.
Out of the 637 patients who applied ruxolitinib at any time during the TRuE-V studies, 46 (7.2%) patients (n=4 while applying vehicle) reported 51 events of any acne. The 51 events included 10 events of acne (n=1 while applying vehicle) and 41 events of application site acne (n=3 while applying vehicle). The median age of the 46 patients with acne events was 37.5 (12-19) years, with the majority (n=36, 78.3%) in adults aged 18-65 years. The majority of patients with acne events were women (n=34, 73.9%), White (n=35, 76.1%), and 80.4% (n=37) of patients had Fitzpatrick skin types I–III.
Most patients did not have a history of acne vulgaris (n=32, 69.6%) and did not have facial acne vulgaris at baseline (n=41, 89.1%). All acne events were mild or moderate (grade 1, n=37 [72.5%]; grade 2, n=14 [27.5%]), and no acne events were considered serious. “Acne was considered possibly related to treatment in 63.0% (n=29) of patients and involved worsening of acne in 17.4% (n=8),” according to the study.
Of the 17 patients with a reported location of acne, facial acne was reported in 15 (88.2%). No patients required ruxolitinib treatment discontinuation because of their acne, and only 1 patient had dose interruption because of their acne. Overall, acne resolved in 45.0% (n=23) of events and was resolving in 9.8% (n=5). Patients received concomitant medication or a procedure/nondrug therapy for 37.3% (n=19) of acne events. Concomitant medications used included retinoids, tetracyclines, and other anti-infectives.
Dermatology Times spoke to study author David Rosmarin, MD, chair and associate professor of the department of dermatology at the Indiana University School of Medicine, regarding the study results and next steps.
Dermatology Times: Can you please provide an overview of the background and purpose of the study you are presenting at EADV regarding the characterization and treatment of acne that occurred among individuals with vitiligo who applied ruxolitinib cream?
Rosmarin: While overall ruxolitinib cream has a favorable benefit to risk ratio, the most common side effect of treatment is acne, which is seen with JAK inhibitors as a class. It is important to understand how frequent this side effect is, who is at risk, how serious are the episodes, and what can be used to treat the acne.
Dermatology Times: What steps come next in terms of continuing to monitor acne resulting from ruxolitinib cream application?
Rosmarin: Having acne at baseline is not a contraindication to treatment with ruxolitinib cream and patients who are worried about this side effect can be reassured that it is usually mild or moderate and often self-resolves. Furthermore, if warranted, dermatologists can add in standard acne treatments to try and assist patients who experience this side effect.