Opzelura cream well-tolerated, effective for treating atopic dermatitis
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Data published in the American Journal of Clinical Dermatology showed that Opzelura cream was a well-tolerated and effective topical treatment for patients with atopic dermatitis.
Opzelura (ruxolitinib, Incyte) — a potent, selective inhibitor of Janus kinase (JAK) 1 and JAK2 — is a topical formulation developed to maximize its clinical effect on skin and minimize the likelihood of absorption, according to the study researchers.
To evaluate the safety profile and efficacy of ruxolitinib, Robert Bissonnette, MD, FRCPC, CEO and medical director at Innovaderm, and colleagues enrolled 41 patients in a maximum-use trial.
Two patients discontinued due to reasons deemed unrelated to treatment.
The median affected body surface area at baseline was 31.2% and the mean EASI was 20.8. Enrolled patients continuously applied 1.5% ruxolitinib cream twice daily for 28 days on all atopic dermatitis lesions.
At follow-up, 31.7% of patients experienced treatment-emergent adverse events, most of which were mild or moderate in severity. The researchers determined that six of these adverse events may have been possibly related to treatment among four patients.
The mean maximal plasma concentration of ruxolitinib peaked at 4 hours after first application. The concentrations were relatively flat over the 28-day dosing period and were lower than the peak on day 1.
Overall, plasma concentrations of ruxolitinib showed no significant change in the systemic circulation and were related to the amount of cream applied and the percentage of body surface area treated.
At 28 days, 35.9% of patients achieved IGA treatment success. Among the 37 patients who continued treatment to day 56, 56.8% achieved IGA treatment success. Most patients had clear or almost clear skin by day 28 with further improvements at day 56.
“Ruxolitinib cream was generally well tolerated, with most [adverse events] of mild or moderate severity,” Bissonnette and colleagues wrote. “Transient increases in mean platelet count at day 15 were observed, which were within the normal range and spontaneously returned to baseline levels by day 28. The underlying mechanism is not clear; however, the increased platelet counts did not appear to have clinical implications.”