The following is a summary of “Long-term safety and disease control with ruxolitinib cream in atopic dermatitis: Results from two phase 3 studies,” published in the MAY 2023 issue of Dermatology by Papp, et al.
Two previous phase 3 trials had shown the safety and efficacy of ruxolitinib cream in atopic dermatitis for up to 8 weeks.
For a study, researchers sought to evaluate ruxolitinib cream’s long-term safety and disease control in atopic dermatitis. Patients initially randomized to receive 0.75% or 1.5% ruxolitinib cream twice daily continued their regimen during a 44-week long-term extension study (as-needed treatment). Patients who received vehicle were rerandomized at week 8 to either 0.75% or 1.5% ruxolitinib cream. Safety and disease control (Investigator’s Global Assessment score 0/1 and affected body surface area) were assessed.
Over 52 weeks, adverse events were reported in 67.4%, 62.6%, 53.5%, and 57.6% of patients in the 0.75% ruxolitinib cream, 1.5% ruxolitinib cream, vehicle to 0.75% ruxolitinib cream, and vehicle to 1.5% ruxolitinib cream groups (n = 426/446/101/99). The most common adverse events were upper respiratory tract infection (10.3%, 11.4%, 5.9%, and 7.1%) and nasopharyngitis (8.9%, 9.9%, 7.9%, and 14.1%). Most adverse events were considered unrelated to treatment. Application site reactions were infrequent (3.8%, 1.8%, 1.0%, and 1.0%). Disease control was achieved throughout the long-term extension study, with 74.1% to 77.8% of patients having Investigator’s Global Assessment 0/1 at week 52, and mean affected body surface area being low (1.4%-1.8%).
Ruxolitinib cream showed effective disease control and tolerability during 44 weeks of as-needed treatment; however, given the low ruxolitinib plasma concentrations and safety data reflecting known risk factors, it is doubtful that systemic Janus kinase inhibition will have any physiological significance.