Ruxolitinib

(Opzelura®)

Opzelura®

Drug updated on 12/11/2024

Dosage FormCream (topical; 1.5%)
Drug ClassJanus kinase (JAK) 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.

Latest News

loading GIF

Summary
This AI-generated content is provided without warranty, with no liability accepted for reliance on it. Learn more.

  • This summary is based on the review of 13 systematic review(s)/meta-analysis(es). [1-13]
  • Vitiligo: Topical ruxolitinib showed a significant improvement in facial vitiligo, with 52% of participants achieving at least 75% improvement in the Facial Vitiligo Area Scoring Index (F-VASI) over 52 weeks (odds ratio (OR) for F-VASI75 = 4.34 [95% confidence interval (CI) 2.67-7.06]; OR for F-VASI50 = 4.71 [95% CI 3.24-6.84]). Additionally, for total body vitiligo, there was an increased likelihood of achieving at least 50% improvement in the Total Vitiligo Area Scoring Index (T-VASI50: OR 4.47 [95% CI 2.52-7.92]), with a mean reduction of -20.22 in T-VASI scores [95% CI -23.11 to -17.33].
  • Eczema (Atopic Dermatitis): Ruxolitinib 1.5% twice daily led to notable improvements in eczema symptoms, showing a significant increase in achieving Eczema Area and Severity Index (EASI-75) (relative risk (RR) = 4.14 [95% CI 3.06-5.61]) and improved pruritus (the Peak Pruritus Numerical Rating Scale (NRS): RR = 4.08 [95% CI 2.86-5.81]). It was effective for mild to moderate atopic dermatitis and demonstrated comparable efficacy to other Janus kinase (JAK) inhibitors and Phosphodiesterase-4 (PDE-4) inhibitors.
  • Comparison with Other Drugs for Eczema: Ruxolitinib 1.5% had comparable effectiveness to delgocitinib and tacrolimus 0.1% in achieving Investigator Global Assessment (IGA) scores. Potent topical steroids, tacrolimus 0.1%, and JAK inhibitors consistently ranked as the most effective treatments for eczema.
  • Subgroup Variability in Vitiligo: The response was highest in facial vitiligo (70% response) compared to vitiligo on extremities (27.3%) or torso/non-sun-exposed areas (13.6%), with concurrent phototherapy enhancing the response across all areas.
  • Vitiligo: Ruxolitinib demonstrated no significant increase in treatment-emergent adverse events (TEAEs) compared to the vehicle (RR 1.46 [95% CI 0.85-2.49]), indicating a favorable safety profile.
  • Eczema (Atopic Dermatitis): Local application site reactions were most common with tacrolimus 0.1% and crisaborole 2%, while ruxolitinib 1.5% showed no statistically significant differences in local reactions compared to other JAK inhibitors. Long-term use of topical steroids, however, was associated with an increased risk of skin thinning (6-60 months), though short-term use did not show this effect.
  • Population Types and Subgroup Considerations: For vitiligo, pediatric, adolescent, and young adult patients demonstrated favorable outcomes with topical ruxolitinib, especially in facial vitiligo and when combined with phototherapy, which significantly enhanced response rates. In eczema (atopic dermatitis), ruxolitinib was effective across diverse demographic groups, including children under 12 years and various ethnic populations, with tacrolimus 0.1% and crisaborole 2% being more likely to cause local application-site reactions.

Product Monograph / Prescribing Information

Document TitleYearSource
Opzelura (ruxolitinib) Prescribing Information.2024Incyte Corporation, Wilmington, DE

Systematic Reviews / Meta-Analyses

Document TitleYearSource
Short-term (24 weeks) treatment efficacy and safety of ruxolitinib cream in participants with vitiligo: a systematic review and meta-analysis2024Systematic Reviews
Topical Anti-Inflammatory Treatments for Eczema: A Cochrane Systematic Review and Network Meta-Analysis2024Clinical and Experimental Allergy : Journal of the British Society for Allergy
Topical anti-inflammatory treatments for eczema: network meta-analysis2024The Cochrane Database of Systematic Reviews
Expert Recommendations on Use of Topical Therapeutics for Vitiligo in Pediatric, Adolescent, and Young Adult Patients2024Jama Dermatology
Efficacy and safety of topical ruxolitinib cream for the treatment of vitiligo: A systematic review and meta-analysis of randomized controlled trials2024Journal of Cosmetic Dermatology
Short-term efficacy and safety of biologics and Janus kinase inhibitors for patients with atopic dermatitis: A systematic review and meta-analysis2023Heliyon
A Review on the Use of Topical Ruxolitinib for the Treatment of Vitiligo2023Journal of Drugs in Dermatology : Jdd
Topical Janus kinase inhibitors in atopic dermatitis: a safety network meta-analysis2023International Journal of Clinical Pharmacy
Efficacy and safety of topical JAK inhibitors in the treatment of atopic dermatitis in paediatrics and adults: A systematic review2023Experimental Dermatology
Itch-free state in patients with atopic dermatitis treated with ruxolitinib cream: A pooled analysis from two randomized phase 3 studies2023Journal of the American Academy of Dermatology
Repigmentation in vitiligo using janus kinase (JAK) inhibitors with phototherapy: systematic review and Meta-analysis2022The Journal of Dermatological Treatment
Efficacy and safety of topical Janus kinase and phosphodiesterase inhibitor-4 inhibitors for the treatment of atopic dermatitis: A network meta-analysis2021The Journal of Dermatology
The efficacy of Janus kinase inhibitors in patients with atopic dermatitis: A systematic review and network meta-analysis2021Dermatologic Therapy

Clinical Practice Guidelines

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