Positive topline data were announced from the pivotal phase 3 TRuE-AD2 study of ruxolitinib cream for the treatment of atopic dermatitis in patients aged ≥12 years.
The phase 3, double-blind, randomized, vehicle-controlled study evaluated the efficacy and safety of ruxolitinib, a Janus kinase (JAK) inhibitor, in a cream formulation compared with vehicle (non-medicated cream) in 618 patients aged ≥12 years with atopic dermatitis. Patients were randomized 2:2:1 to receive either ruxolitinib cream 0.75% or 1.5% twice daily or vehicle for 8 weeks. The primary end point was the proportion of patients achieving an Investigator’s Global Assessment Treatment Success (IGA-TS), defined as a score of 0 (clear) or 1 (almost clear).
Results showed that a significantly greater proportion of patients treated with ruxolitinib (0.75% or 1.5%) cream met the primary end point with at least a 2-point improvement from baseline at week 8 compared with those treated with the vehicle. The safety profile of ruxolitinib was consistent with that observed in previous studies. The Company plans to offer a 44-week long-term safety extension period to patients who have successfully completed the 8-week study.
Full study data from the TRuE-AD2 study will be submitted for presentation at an upcoming scientific meeting.
“This positive topline result reinforces the potential of ruxolitinib cream, if approved, to offer [atopic dermatitis] patients a much-needed effective, nonsteroidal therapy,” said Jim Lee, MD, Group Vice President, Inflammation & AutoImmunity, Incyte. “We look forward to the results of the TRuE-AD1 trial, the second study in the pivotal clinical trial program, later this quarter, and to sharing these data with the medical community as part of our commitment to develop a new first-line treatment option for these patients.”
Ruxolitinib is currently available in an oral tablet formulation for the treatment of intermediate or high-risk myelofibrosis (MF), including primary MF, post-polycythemia vera MF and post-essential thrombocythemia MF; for the treatment of polycythemia vera in patients with an inadequate response to, or intolerant of, hydroxyurea; and for the treatment of steroid-refractory acute graft-versus-host disease.
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