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Long-term safety and disease control with ruxolitinib cream in atopic dermatitis: results from two phase 3 studies

Papp K, Szepietowsi J, Kircik L, et al. 2022.
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IMPORTANT INFORMATION FOR READERS

This reprint contains information not included in the FDA-approved labeling for OPZELURA™ (ruxolitinib) cream 1.5%.
  • TRuE-AD1 and TRuE-AD2 were identically designed, double-blind, randomized, vehicle-controlled trials.
  • Patients initially randomized to twice-daily 0.75%/1.5% ruxolitinib cream maintained their regimen during the 44-week LTS period (as-needed treatment). Patients on vehicle were rerandomized (1:1) at Week 8 to either ruxolitinib cream strength. Safety and disease control (Investigator’s Global Assessment [IGA] score 0/1 and affected body surface area [BSA]) were assessed.
  • Data were pooled from TRuE-AD1 and TRuE-AD2 and analyzed by descriptive 164 statistics. The safety population included all randomized patients who continued in the 165 LTS period.
  • Disease control data (IGA 0/1 and affected BSA) are reported as observed.
  • Limitation: The Long-term safety trial had no control treatment.
  • Incyte Corporation conducted a comprehensive literature search at time of publication and did not identify any publications with contrary results.