Opzelura (ruxolitinib) has been FDA approved for eczema. Opzelura is a topical JAK inhibitor, and its indicated for short term use in patients 12 and up who have mild to moderate atopic dermatitis. It is the first topical janus kinase inhibitor approved in the United States.
Currently for atopic dermatitis topical treatment, the mainstay of treatment are topical corticosteroids, such as hydrocortisone, triamcinolone and there are many to choose from. Elidel/Protopic were the next topical treatments approved, followed by Eucrisa. Opzelura is the first topical therapy in its class to be approved for eczema.
We have discussed extensively in the past JAK inhibitors for atopic dermatitis, but most of them are being studied in the oral form.
JAK inhibitors block an inflammatory pathway that lead to different immune responses. JAK inhibitors are currently used inflammatory diseases such as rheumatoid arthritis and treatments of cancer.
The approval of Ruxolitinib was based on 2 phase 3 studies involving more than 1200 patients with mild to moderate eczema. Approximately 52% of patients receiving Ruxolitinib reached the primary endpoint of treatment goals after 8 weeks.
The most common adverse events were nasopharyngitis, diarrhea, bronchitis and ear infections. Although more adverse events can be reported once the medication is used in a broader population.
With other oral JAK inhibitors on the way, it remains to be seen which treatment would be better in the topical vs. the oral route of these medications.
Most new medications like Opzelura are significantly expensive when they are first released on the market. But the manufacturer, in this case Incyte Dermatology, provides coupons or discounts to patients when the drug is not covered by insurance companies.
Stay tuned for more information, Ruxolitinib cream is also being evaluated for the treatment of vitiligo. To read more, please click on the link below regarding a blog that was written about it last year.