Ruxolitinib

(Opzelura®)

Opzelura®

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Drug updated on 5/17/2024

Dosage FormCream (topical; 1.5%)
Drug ClassJanus kinase inhibitors
Ongoing and
Completed Studies
ClinicalTrials.gov

Indication

  • 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 topical prescription therapies or when those therapies are not advisable.
  • Indicated for the topical treatment of nonsegmental vitiligo in adult and pediatric patients 12 years of age and older.

Summary
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  • 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 topical therapies or when those therapies are not advisable. It is also used for the topical treatment of nonsegmental vitiligo in adult and pediatric patients 12 years of age and older.
  • Nine studies were reviewed, providing comprehensive insight into Ruxolitinib's safety, efficacy, patient subgroup considerations, as well as comparisons with other drugs used for similar conditions.
  • In terms of Atopic Dermatitis (AD), Ruxolitinib demonstrated significant improvement in outcomes such as EASI 75 and Pruritus NRS4. Its safety profile was found to be comparable to treatments like dupilumab when combined with Topical Corticosteroids (TCS) for moderate-to-severe AD cases.
  • For treating nonsegmental vitiligo, JAK inhibitors including ruxolitinib showed promising results, especially when combined with concurrent phototherapy, which significantly increased rates of good overall response.
  • When evaluated against steroid-refractory Graft-versus-Host Disease post-Hematopoietic stem cell transplantation (HSCT), it displayed potential effectiveness, with common adverse events like cytopenia and infectious complications being noted during its use.
  • Ruxolitinib has shown notable effectiveness specifically among facial vitiligo subgroups compared to other body areas; lower GVHD grades and moderate chronic GVHD associated with better clinical outcomes, indicating varied responses across different patient subgroups.

Product Monograph / Prescribing Information

Document TitleYearSource
Opzelura (ruxolitinib) Prescribing Information.2023Incyte Corporation, Wilmington, DE

Systematic Reviews / Meta-Analyses

Clinical Practice Guidelines

Document TitleYearSource
A living WHO guideline on drugs for COVID-19.2020WHO