Ruxolitinib

(Opzelura®)

Opzelura®

Drug updated on 9/4/2024

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.

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Summary
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  • Opzelura (ruxolitinib) 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 prescription therapies or when those therapies are not advisable; and for the topical treatment of nonsegmental vitiligo in adult and pediatric patients 12 years of age and older.
  • This summary is based on the review of nine systematic review(s)/meta-analysis(es). [1-9]
  • Alopecia Areata (AA): Brepocitinib 30mg was most effective in reducing the SALT score and had the highest probability of achieving a SALT50 response. Deuruxolitinib 12mg showed the highest probability of achieving a SALT75 response. No population differences were noted.
  • Atopic Dermatitis (AD) - Systemic and Topical Treatments: Dupilumab and upadacitinib demonstrated superior outcomes in EASI 90, IGA 0/1, EASI 75, and Pruritus NRS4, with ruxolitinib effective for EASI 75 and Pruritus NRS4 in mild to moderate AD. No population differences were noted.
  • Vitiligo: Ruxolitinib showed a good response in 57.8% of cases, with the highest good response rate of 70% in facial vitiligo. Concurrent UVB phototherapy improved the treatment efficacy.
  • Alopecia Areata (AA): Ruxolitinib cream demonstrated a relatively acceptable short-term safety profile; deuruxolitinib had a greater likelihood of causing adverse events, while ritlecitinib 50mg exhibited fewer adverse effects.
  • Atopic Dermatitis (AD) - Systemic and Topical Treatments: Ruxolitinib showed a good safety profile and minimal risk of mild-to-moderate adverse effects. Baricitinib combined with TCS had a higher incidence of serious adverse events. Dupilumab combined with TCS demonstrated greater efficacy and safety.
  • Adults and pediatric populations were included in studies on AD treatments, with delgocitinib showing great efficacy in pediatric AD; for vitiligo, facial vitiligo had the highest good response rate with JAK inhibitors, and concurrent UVB phototherapy improved efficacy.

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