Drug updated on 4/17/2024
| Dosage Form | Cream (topical; 1.5%) |
| Drug Class | Janus kinase inhibitors |
| Ongoing and Completed Studies | ClinicalTrials.gov |
Indication
- For the topical short-term and non-continuous chronic treatment of mild to moderate atopic dermatitis in non-immunocompromised adult and pediatric patients 12 years of age and older whose disease is not adequately controlled with topical prescription therapies or when those therapies are not advisable.
- For the topical treatment of nonsegmental vitiligo in adult and pediatric patients 12 years of age and older.
Summary
- Ruxolitinib (Opzelura) is indicated for the topical short-term and non-continuous chronic treatment of mild to moderate atopic dermatitis in non-immunocompromised adult and pediatric patients 12 years of age and older whose disease is not adequately controlled with other therapies or when those therapies are not advisable. It's also used for the topical treatment of nonsegmental vitiligo in adult and pediatric patients 12 years of age and older.
- The information about Ruxolitinib was derived from a single systematic review/meta-analysis study, which primarily focused on infections associated with its use in Myeloproliferative Neoplasm (MPN) patients.
- In terms of safety profile, there was no significant difference observed in the risk of overall infections during early stages compared to controls. However, an increased risk for herpes zoster infection was noted both at early stage usage as well as extension phase.
- A decrease in overall infection risks over time has been observed among MPN patients receiving Ruxolitinib during extension phases, indicating potential improvement regarding infection-related outcomes over time.
- The reviewed study does not provide direct comparisons between Ruxolitinib's effectiveness or safety against other methods for treating atopic dermatitis or vitiligo; hence, any comparison would be speculative based on this data alone.
- The study did not specify subgroup considerations within MPN patient population that might influence their response towards Ruxolitinib therapy, such as demographic factors, disease severity, or previous treatment history.
Product Monograph / Prescribing Information
| Document Title | Year | Source |
|---|---|---|
| Opzelura (ruxolitinib) Prescribing Information. | 2023 | Incyte Corporation, Wilmington, DE |
Systematic Reviews / Meta-Analyses
| Document Title | Year | Source |
|---|---|---|
| Effects of ruxolitinib on infection in patients with myeloproliferative neoplasm: A meta-analysis. | 2021 | Hematology |
Clinical Practice Guidelines
| Document Title | Year | Source |
|---|---|---|
| A living WHO guideline on drugs for COVID-19. | 2020 | WHO |