OPZELURA WAS ASSESSED IN A 44-WEEK EXTENSION PERIOD1

  • Patients initially randomized to OPZELURA in the TRuE-AD clinical trials remained on their regimen
  • Patients initially randomized to vehicle were rerandomized 1:1 to ruxolitinib cream 0.75% or OPZELURA
  • Patients self-evaluated active AD lesions and treated as needed BID (up to 20% BSA)*
  • Study visits occurred every 4 weeks

*Patients were instructed to stop treatment 3 days after lesion clearance and restart treatment again at the first sign of recurrence. If new lesions were extensive or appeared in new areas, patients were instructed to contact the investigator to determine if an unscheduled additional visit was needed. Rescue treatment was not permitted.

AD=atopic dermatitis; BID=twice daily; BSA=body surface area.

 
  • Safety and tolerability assessments included the frequency of reported TEAEs, treatment-related AEs, and AEs leading to discontinuation
  • Disease control assessed by:
  • Proportion of patients with clear (IGA 0) or almost clear (IGA 1) skin
  • Mean total affected BSA

AE=adverse event; BSA=body surface area; IGA=Investigator’s Global Assessment; TEAE=treatment-emergent adverse event.

See 52-week adverse events profile >

Reference: 1. Papp K, Szepietowski JC, Kircik L, et al. Long-term safety and disease control with ruxolitinib cream in atopic dermatitis: results from two phase 3 studies. Presented at: Revolutionizing Atopic Dermatitis Virtual Conference; June 13, 2021.