FAQ - Opzelura (Ruxolitinib) Cream
What is Opzelura?
Opzelura (ruxolitinib 1.5%) cream is a topical selective Janus kinase (JAK) inhibitor approved by the FDA for the short-term and non-continuous treatment of mild to moderate atopic dermatitis in non-immunocompromised (patients without weakened immune systems) adult and pediatric patients 12 years of age and older who disease is not adequately controlled with topical prescription therapies or when those therapies are not advisable.
Mild to moderate atopic dermatitis is generally determined by skin involvement (how much of your body surface is affected) and severity of symptoms such as itch and rash. It’s important to talk to your doctor about how atopic dermatitis affects not just your skin but also other aspects of your life.
Together, you and your healthcare provider can determine if Opzelura is an appropriate treatment option.
How does Opzelura work?
Opzelura is not a topical steroid. It works by specifically blocking JAK1 and JAK2, two enzymes that are involved in several cytokine pathways that contribute to inflammation in the skin, itch, and skin barrier function.
Reducing the activity of JAK1 and JAK2 in atopic dermatitis can lead to fewer and/or less severe signs and symptoms by reducing itch, rash, and skin redness.
How do you use Opzelura?
Opzelura (ruxolitinib 1.5%) is applied as a thin film directly to the affected areas of skin twice daily (up to 20% of the body surface area for up to 8 weeks). Additional usage should be discussed with your healthcare provider.
How effective is Opzelura for atopic dermatitis?
In two Phase 3 clinical trials for Opzelura1, after 8 weeks of continuous use:
- 53.8% and 51.3% of patients achieved the primary endpoint Investigator Global Assessment-Treatment Success (IGA-TS) of 0-1 (clear or almost clear) with at least a 2-grade improvement from the start of the trial.
- This improvement compared with 7.6% of those using a vehicle only.
- Investigator Global Assessment (IGA) is a 5-point scale that provides a global clinical assessment of atopic dermatitis by the investigator, based on signs and symptoms.
Secondary endpoints in these trials after 8 weeks of continuous use included:
- Proportion of patients achieving a 75% improvement in the Eczema Area and Severity Index (EASI-75; an investigator tool used to measure the extent (area) and severity of atopic dermatitis):
- 62.1% and 61.8% of patients using Opzelura achieved EASI-75
- Proportion of patients with a reduction in itch severity (NRS4; at least a 4-point decrease on an 11-point (0-10) numeric rating scale)
- 52.2% and 50.7% of patients using Opzelura achieved NRS4
- Reductions in itch began as early as 12 hours after first application.
- 52.2% and 50.7% of patients using Opzelura achieved NRS4
- Proportion of patients with improved sleep quality (at least a 6-point improvement (out of 40 maximum) rated using an 8-question form)
- 22.3% and 25.6% of patients using Opzelura improved sleep quality
What is a ‘black box’ warning, and why does Opzelura have one?
A boxed warning, more commonly referred to a ‘black box’ warning, can be found on prescription drug labelling and package inserts, depending on the type of side effects the drug may have as determined by the FDA, which regulates all drugs in the United States.
While some drugs have minimal side effects, others can have the risk of more serious ones. An FDA-issued black box warning draws attention to a drug with the potential for more serious or in some cases, life threatening risks, to alert healthcare providers and their patients to these considerations.
For Opzelura (ruxolitinib) cream, the black boxed warning includes information about the risk for serious infections, major adverse cardiovascular events, clotting (thrombosis), cancer, and all-cause mortality for patients taking JAK inhibitors orally (by mouth).
A conversation with your healthcare provider is the best way to determine if the benefits of Opzelura outweigh the potential risk, as well as the need for any baseline and/or ongoing monitoring.
What are the side effects of Opzelura?
The most common treatment-emergent adverse reactions from clinical trials1 (incidence greater than/equal to 1%) are swelling of nasal passages, diarrhea, bronchitis, ear infection, increased eosinophil counts, urticaria, folliculitis, tonsillitis, and runny nose. The incidence of these adverse reactions was similar to those treated with the placebo in clinical trials.
Opzelura is a topical formulation of oral ruxolitinib (Jakafi) that was developed to deliver the drug directly to affected skin and limit the potential for side effects from oral administration.
Serious adverse effects during the Phase 3 clinical trials for Opzelura occurred infrequently (less than 1% of participants) and were determined to be unrelated to use of Opzelura by study investigators.1
The full prescribing information for Opzelua can be found here.
How is Opzelura different from topical corticosteroids (TCS)?
Topical corticosteroids work to reduce inflammation in the skin by preventing cells from producing inflammation-causing chemicals that are released in response to a variety of different triggers.
Opzelura reduces inflammation by more specifically inhibiting specific enzymes, JAK1 and JAK2, that can contribute to skin inflammation. And because Opzelura is not a TCS, it is able to be used over a longer period of time (up to 8 weeks), and on body areas that are more delicate or have thinner skin such as the face, eyelids, genitals, or skin folds, where TCS use is not preferred.
How long do I have to take Opzelura?
Opzelura is FDA-approved for short-term (8-week) use as part of an atopic dermatitis treatment regimen or more intermittently (on/off) depending on your atopic dermatitis symptoms and areas of skin affected. Together, you and your healthcare provider can determine what is the most appropriate treatment approach with Opzelura, including overall duration of use.
Can children use Opzelura?
Opzelura is FDA-approved for children ages 12 years and older.
How much does Opzelura cost?
Cost depends on your health insurance coverage for prescriptions. Incyte, the company that makes Opzelura, has programs to help with your copay costs if needed. You can apply at IncyteCARES or call 1-800-583-6964, Monday through Friday, from 8 a.m. to 8 p.m. ET.
How do I know if Opzelura is right for me?
It’s important to talk to your doctor about how atopic dermatitis affects your skin and other aspects of your life. Together, you and your healthcare provider can determine if Opzelura is an appropriate treatment option.
How can I get Opzelura?
Opzelura is available by prescription only. Talk to your health care provider and visit opzelura.com to learn more.
Can I use Opzelura with other prescription atopic dermatitis therapies?
Talk to your health care provider about using Opzelura with other prescription and over the counter therapies for atopic dermatitis. Opzelura has not been studied in combination with biologics, other JAK inhibitors, or immunosuppressants such as azathioprine or cyclosporine.
Be sure your doctor knows all medications you are using for your atopic dermatitis as well as other medical conditions.
1Papp K, Szepietowski JC, Kircik K, Toth D, Eichenfield LF, Leung DYM et al. Efficacy and safety of Opzelura for the treatment of atopic dermatitis: Results from Two Phase 3, Randomized, Double-Blind Studies. J Am Acad Dermatol. 2021. Doi: https://doi.org/10/1016/j.jaad.2021.04.085. Online ahead of print.