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Vitiligo is a common acquired skin depigmentation disease characterized by white spots or patches caused by the loss of epithelial pigment cells. [1] The pathogenesis of vitiligo is still unclear, so there is no cure for this disease at home and abroad. The global incidence of vitiligo is about 1% to 5%, and there is no significant difference in the incidence between men and women.

There are many factors related to the onset of vitiligo, and most current studies believe that immune damage, oxidative stress, heredity, etc. are its main pathogenesis. The treatment of vitiligo mainly includes drug treatment, physical therapy and surgical treatment. [2] Recently, Medical Travel learned that Incyte Biopharmaceutical Company of the United States announced that the United States (FDA) has approved Opzelura (ruxolitinib, ruxolitinib) 1.5% cream for the topical treatment of adults and adolescent and adult patients 12 years old and above with non-segmental vitiligo.

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Can naruxolitinib cream cure vitiligo?

It cannot be cured, but it can be improved. Ruxolitinib cream may be an effective drug for treating vitiligo, and this can be well proven according to various studies. In patients with non-segmental vitiligo, ruxolitinib cream is approved for continuous topical use twice daily to up to 10% of the affected area's body surface area. Patients with vitiligo need to be treated for more than 24 weeks to achieve a satisfactory clinical response, which also breaks the original situation of no cure for vitiligo.

Opzelura (ruxolitinib cream) improves body pigmentation at week 24

The approval of Opzelura is based on data from a pivotal Phase III TRuE-V clinical trial program (TRuE-V1 and TruE-V2), which evaluated Opzelura in more than 600 adolescent and adult patients aged 12 years and older with non-segmental vitiligo. Safety and efficacy in patients, the study concluded, treatment with Opzelura resulted in significant improvements in VASI scores, representing improvements in patient facial and systemic pigmentation compared with vehicle (non-medicated cream) at week 24 (preliminary analysis) and in open-label expansion at week 52.

The results at week 24 were consistent with those from both studies, showing that approximately 30% of patients treated with Opzelura had a ≥75% improvement from baseline in the primary endpoint of Facial Vitiligo Area Score Index (F-VASI75), and more than 15% of patients had an improvement in F-VASI (F-V ASI90) achieved ≥90% baseline improvement compared to approximately 2% of patients treated with vehicle, and approximately 50% of patients treated with Opzelura achieved Vitiligo Area Score Index (F-VASI75) at week 52, demonstrating efficacy.

During the vehicle-controlled period of the Phase III study, the most common adverse reactions (incidence ≥1%) in the Opzelura group were application site acne, application site pruritus, nasopharyngitis, headache, urinary tract infection, application site erythema, and fever. Opzelura's label includes warnings for serious infections, mortality, malignancy, adverse cardiovascular events and thrombotic events.

Ruxolitinib cream progress in other medical fields

Ruxolitinib cream is the first and only topical formulation of a JAK inhibitor in the United States (FDA). In addition to being suitable for vitiligo, the FDA has also approved Opzelura cream for the short-term or non-sustained chronic treatment of patients with mild to moderate atopic dermatitis (AD). The treatment success rate and safety are good.

References

[1] Zhang Wenchao, Liu Zhifei, Wang Xiaojun, Zeng Ang, Zhu Lin, Yu Nanze, Si Loubin, Zhang Mingzi, Qin Feng. Overview of vitiligo research and progress in surgical treatment [J]. Journal of Medical Research, 2019, 48(08): 178-181.

[2] Zhao Yanxia, Jia Tingting, Wang Pengyu, Zhang Junling, Ding Suxian. Research status of clinical characteristics of vitiligo [J]. Chinese Journal of Dermatology and Venereology of Integrated Traditional Chinese and Western Medicine, 2020, 19(04): 388-390.

[3]IncyteAnnouncesU.S.FDAApprovalofOpzelura™(ruxolitinib)Cream;fortheTreatmentofVitiligo