Ruxolitinib cream has antipruritic, anti-inflammatory mode of action in atopic dermatitis
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Ruxolitinib demonstrated efficacy and a dual mode of action among patients with atopic dermatitis, according to a poster at South Beach Symposium Medical Dermatology Summit.
“Ruxolitinib cream is a topical selective inhibitor of JAK1 and JAK2 in development for the treatment of AD,” Kim Papp, MD, PhD, and colleagues wrote in the poster. “In a phase 2 study, ruxolitinib cream provided high rates of strength-dependent efficacy in patients with AD and a safety profile similar to vehicle.”
To assess the efficacy and safety of ruxolitinib cream, Papp and colleagues pooled data from two phase 3 studies of patients aged 12 years and older who had AD for 2 or more years, an Investigator’s Global Assessment score of 2 or 3 and an affected body surface area of 3% to 20%. In both studies, researchers randomly assigned 240 patients (median age, 33 years; adults, 78.4%; female patients, 60.8%) to 0.75% ruxolitinib twice per day, 240 patients (median age, 31 years; adults, 81.6%; female patients, 61.7%) to 1.5% ruxolitinib twice per day and 120 patients (median age, 34 years; adults, 82%; female patients, 63.6%) to vehicle.
The study’s primary endpoint was the proportion of patients who had IGA treatment success, which researchers defined as an IGA score of 0 or 1, with a two or more grade improvement from baseline at week 8. Other endpoints included the proportion of patients who had 75% or greater improvement in Eczema Area and Severity Index score, four or more point improvement in itch numerical rating scale score (NRS4) and six or more point improvement in Patient-Reported Outcomes Measurement Information System (PROMIS) Short Form-Sleep Disturbance (8b).
A higher proportion of patients in the ruxolitinib groups had IGA treatment success at week 8 compared with vehicle (44.7% for 0.75% and 52.6% for 1.5% vs. 11.5% for vehicle; both P < .0001).
More patients achieved EASI-75 at week 8 in the 1.5% group (62%) and 0.75% group (53.8%) vs. vehicle (19.7%; both P < .0001). More patients in the treatment groups achieved NRS4 (51.5% for 1.5% and 41.5% for 0.75%) vs. vehicle (15.8%; both P < .0001). There was also a higher proportion of patients who had PROMIS 8b response in the 1.5% (23.8%) and 0.75% (20.9%) groups vs. vehicle (14.2%; both P < .05).
The researchers wrote that ruxolitinib was “well tolerated and not associated with clinically significant application site reactions.” In addition, there were no serious adverse events related to ruxolitinib and “no treatment-emergent [adverse events] suggestive of a relationship to bioavailability.”
“Ruxolitinib cream demonstrated a dual mode of action: antipruritic and anti-inflammatory,” they wrote. “These results demonstrate the potential of ruxolitinib cream as an effective and well-tolerated topical treatment for AD.”