Long-term safety and disease control with ruxolitinib cream in atopic dermatitis: Results from two phase 3 studies - 14/04/23
, Jacek C. Szepietowski, MD, PhD b, Leon Kircik, MD c, Darryl Toth, MD d, Lawrence F. Eichenfield, MD e, Seth B. Forman, MD f, Michael E. Kuligowski, MD, PhD, MBA g, Howard Kallender, PhD g, Kang Sun, PhD g, Haobo Ren, PhD g, Eric L. Simpson, MD, MCR hAbstract |
Background |
Ruxolitinib cream demonstrated safety and efficacy over 8 weeks in 2 double-blind phase 3 atopic dermatitis studies (NCT03745638/NCT03745651).
Objective |
To evaluate long-term safety (LTS) and disease control with ruxolitinib cream.
Methods |
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 score 0/1 and affected body surface area) were assessed.
Results |
Over 52 weeks, adverse events were reported in 67.4%/62.6%/53.5%/57.6% of patients in 0.75%/1.5% ruxolitinib cream/vehicle to 0.75% ruxolitinib cream/vehicle to 1.5% ruxolitinib cream groups (n = 426/446/101/99). Most common adverse events were upper respiratory tract infection (10.3%/11.4%/5.9%/7.1%) and nasopharyngitis (8.9%/9.9%/7.9%/14.1%). Most adverse events were considered unrelated to treatment. Application site reactions were infrequent (3.8%/1.8%/1.0%/1.0%). Disease control was achieved throughout the LTS; 74.1% to 77.8% of patients had Investigator's Global Assessment 0/1 at week 52, and mean affected body surface area was low (1.4%-1.8%).
Limitations |
LTS had no control treatment.
Conclusion |
During 44 weeks of as-needed treatment, ruxolitinib cream demonstrated effective disease control and tolerability; low ruxolitinib plasma concentrations alongside safety findings reflecting known risk factors suggest physiologically meaningful systemic Janus kinase inhibition is highly unlikely.
Le texte complet de cet article est disponible en PDF.Abbreviations used : AD, AE, BSA, Css DVT, HZ, IGA, JAK, LTS, NMSC, PY, TEAE, VC
Plan
| Funding sources: This study was funded by Incyte Corporation (Wilmington, DE, USA). |
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| IRB approval statement: The study protocols and all amendments were reviewed and approved by the institutional review board at each site. |
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| Patient consent: Not applicable. |
Vol 88 - N° 5
P. 1008-1016 - mai 2023 Retour au numéro
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