Ruxolitinib, sold under the brand name Opzelura, has been approved by the FDA for the treatment of eczema. Opzelura is the only topical Janus kinase (JAK) inhibitor approved for use in the United States.
JAK is an enzyme that transmits signals from a cell membrane to within the cell. They are involved in many cellular processes, including:
- Immune response
- Blood formation
- Cell growth and division
- Transformation of cells
- Cell death
JAKs stimulate immune cells to produce inflammatory proteins that cause an overactive inflammatory response in people with autoimmune conditions. People with eczema have an overactivity of JAK signaling that causes inflammation. JAK inhibitors work by interrupting the signal activity of these enzymes.
Opzelura is approved for short-term and non-continuous treatment of chronic eczema that hasn't improved with other topical prescription medicines or in the cases of people who can't use other topical prescription medicines. It's only approved for people over the age of 12 who aren't immunocompromised.
The FDA granted approval of Opzelura after the results of the TRuE-AD (Topical Ruxolitinib Evaluation in Atopic Dermatitis) Phase 3 studies. These studies showed that people who used Opzelura had clearer skin and less itching than people who were given a nonmedicated cream.
Opzelura is used by applying a thin layer to the affected skin twice a day, but it can't be used on more than 20 percent of the body's surface. The maximum dose is 60 grams weekly.
Opzelura's common side effects can include:
- Inflammation of the nose and throat
- Diarrhea
- Bronchitis
- Ear infection
- Hives
- Increased white blood cells
- Runny nose
- Inflammation of tonsils
- Inflammation of hair follicles
It may also cause some serious side effects, including:
- Serious infections that may lead to death
- Sudden cardiovascular death
- Blood clots
- Lymphoma and other cancers
- Abnormalities in blood cells
