Integrated Safety Analysis of Ruxolitinib Cream: Data From 20 Clinical Studies in Inflammatory Dermatologic Conditions

Main Article Content

Karen Miller
Citrus Health Group

Christopher G. Bunick
Yale School of Medicine

Khaled Ezzedine
Henri Mondor University Hospital and Université Paris-Est Créteil Val de Marne

Lawrence F. Eichenfield
University of California San Diego School of Medicine

Robert Bissonnette
Innovaderm Research

Thierry Passeron
Centre Hospitalier Universitaire de Nice, Université Côte d’Azur; INSERM U1065, C3M, Université Côte d’Azur

Daniel Sturm
Incyte Corporation

Haobo Ren
Incyte Corporation

Yun Su
Incyte Corporation

David Rosmarin
Indiana University School of Medicine

Keywords

Safety, JAK (Janus kinase)

References

1. Miot HA, et al. An Bras Dermatol. 2023;98(5):656-677.

2. Papp K, et al. J Am Acad Dermatol. 2023;88(5):1008-1016.

3. Rosmarin D, et al. N Engl J Med. 2022;387(16):1445-1455.

4. Olsen EA, et al. J Am Acad Dermatol. 2020;82(2):412-419.

5. Porter ML, et al. Ruxolitinib cream for mild-to-moderate hidradenitis suppurativa: 32-week data from a randomized phase 2 study. Presented at: European Academy of Dermatology and Venereology; September 25-28, 2024; Amsterdam, The Netherlands.

6. Mangold AR, et al. Efficacy and safety of ruxolitinib cream in patients with cutaneous lichen planus: results from a phase 2, randomized, vehicle-controlled study. Presented at: European Academy of Dermatology and Venereology Congress; September 25-28, 2024; Amsterdam, The Netherlands.

7. Opzelura® (ruxolitinib cream). Full Prescribing Information. Incyte Corporation; 2025.

8. Incyte Corporation and Innomar Strategies. Opzelura® (ruxolitinib cream). Product Monograph. 2024.

9. US Food and Drug Administration. FDA requires warnings about increased risk of serious heart-related events, cancer, blood clots, and death for JAK inhibitors that treat certain chronic inflammatory conditions. 2021. Accessed February 2, 2024. https://www.fda.gov/drugs/drug-safety-and-availability/fda-requires-warnings-about-increased-risk-serious-heart-related-events-cancer-blood-clots-and-death

10. Ytterberg SR, et al. N Engl J Med. 2022;386(4):316-326.

11. Opzelura® (ruxolitinib cream). Summary of Product Characteristics. 2023.

12. China Medical System Holdings. China Medical System: First Ruxolitinib Cream’s Prescriptions for Vitiligo Issued in the Greater Bay Area. 2024. GlobeNewsWire. Accessed December 2, 2024. https://www.globenewswire.com/news-release/2024/10/18/2965345/0/en/China-Medical-System-First-Ruxolitinib-Cream-s-Prescriptions-for-Vitiligo-Issued-in-the-Greater-Bay-Area.html.

13 Opzelura® (ruxolitinib cream). Summary of Product Characteristics. 2023.

14. Wan J, et al. Br J Dermatol. 2022;186(4):664-672.

15. Hedderson MM, et al. PLoS One. 2022;17(11):e0277469.

16. Ivert LU, et al. Acta Derm Venereol. 2019;99(10):865-870.

17. Silverwood RJ, et al. BMJ. 2018;361:k1786.

18. Wan J, et al. J Allergy Clin Immunol Pract. 2023;11(10):3123-3132.

19. Meyers KJ, et al. Dermatol Ther (Heidelb). 2021;11(3):1041-1052.

20. Warren RB, et al. Br J Dermatol. 2023;189(4):427-436.

21. Castellsague J, et al. Clin Epidemiol. 2018;10:299-310.

22. Hedderson MM, et al. BMJ Open. 2023;13(3):e071172.

23. Wan J, et al. Br J Dermatol. 2023;189(1):53-61.

24. Arana A, et al. Br J Dermatol. 2010;163(5):1036-1043.

25. Asgari MM, et al. JAMA Dermatol. 2020;156(10):1066-1073.

26. Fleischmann-Struzek C, et al. Intensive Care Med. 2020;46(8):1552-1562.

27. Rudd KE, et al. Lancet. 2020;395(10219):200-211.

28. Keller K, et al. Int J Cardiol. 2019;287:132-138.

29. Institute for Health Metrics and Evaluation. Global Burden of Disease Study 2021. Accessed June 21, 2024. https://vizhub.healthdata.org/gbd-results/.

30. Eurostat. Cardiovascular diseases statistics. 2020. European Commission. Accessed June 21, 2024. https://ec.europa.eu/eurostat/statistics-explained/index.php?title=Cardiovascular_diseases_statistics.

31. Lutsey PL, Zakai NA. Nat Rev Cardiol. 2023;20(4):248-262.

32. GLOBOCAN, et al. Global Cancer Observatory: Cancer Today (version 1.1). 2024. International Agency for Research on Cancer. Accessed June 15, 2024. https://gco.iarc.who.int/today.

33. King B, et al. A comparison of the risk of major cardiocascular events, venous thromboembolism, serious infections, and malignancies among patients with vitiligo in the United States using real-world data. Presented at: American Academy of Dermatology; March 7-11, 2025; Orlando, FL, USA.

34. Schneeweiss MC, et al. JAMA Dermatol. 2021;157(7):805-816.

35. Paradisi A, et al. J Am Acad Dermatol. 2014;71(6):1110-1116.

36. Quintás-Cardama A, et al. Blood. 2010;115(15):3109-3117.

37. Leung DYM, et al. Ann Allergy Asthma Immunol. 2023;130(4):500-507.

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2025-11-10
DOI: https://doi.org/10.25251/36mxmk39

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1.
Integrated Safety Analysis of Ruxolitinib Cream: Data From 20 Clinical Studies in Inflammatory Dermatologic Conditions. J of Skin. 2025;9(6):s711. doi:10.25251/36mxmk39
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Vol. 9 No. 6 (2025): November 2025 Issue
Section
Dermatopharmacology
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