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Published On: Oct 26, 2022
Last Updated On: Oct 26, 2022
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The immune system is our body’s defense against germs in the environment that could make us ill1. But, for the more than 21 million people living with atopic dermatitis (AD)2, over-activity of the immune system can have a harmful effect on proteins in the body responsible for keeping skin healthy3. This can result in itchy skin, dry and scaly patches, and red lesions on the body4.
Because everyone’s experience with AD is unique, one of the best treatment approaches is to build a trusting relationship with a dermatologist. Incyte, a global pharmaceutical company committed to supporting people living with dermatologic conditions, is encouraging people living with AD to take this first step — fostering open conversations about AD triggers and symptoms with a dermatologist to develop a treatment plan that helps address their individualized needs.
One potential treatment for consideration is OpzeluraTM (ruxolitinib) cream 1.5%, which was FDA-approved in September 2021 for the treatment of mild to moderate AD in non-immunocompromised adults and children 12 years of age and older whose disease is not well controlled with topical prescription therapies or when those therapies are not recommended. Opzelura is the first approved topical Janus kinase (JAK) inhibitor in the U.S., representing an important treatment option for people with mild to moderate AD and their healthcare providers5. Opzelura is a non-steroidal cream that is applied directly to the areas of the skin affected by mild to moderate AD. It has been studied across a range of skin tones and can be used on some sensitive areas like the face. Opzelura is for use on the skin only. Do not use in your eyes, mouth or vagina.
In clinical trials, Opzelura offered significantly clearer skin and itch reduction in a topical application compared to a placebo cream. In those trials, more than half of patients achieved clear or almost clear skin and experienced a significant reduction in itch after eight weeks while using Opzelura twice daily compared to 15% of those using a placebo cream. The most common (≥1%) side effects associated with Opzelura are common cold (nasopharyngitis), diarrhea, bronchitis, ear infection, increase in a type of white blood cell (eosinophil) count, hives, inflamed hair pores (folliculitis), swelling of the tonsils (tonsillitis), and runny nose (rhinorrhea). Please see below for Important Safety Information, including Boxed Warnings for serious infections, mortality, malignancy, major adverse cardiovascular events and thrombosis.
Opzelura may work for some, but not all people, with AD. If you have mild to moderate AD and are interested in learning more about Opzelura, make an appointment with your dermatologist or visit opzelura.com.
INDICATION AND USAGE
OPZELURA is a prescription medicine used on the skin (topical) for the short-term and non-continuous chronic treatment of mild to moderate eczema (atopic dermatitis) in non-immunocompromised adults and children 12 years of age and older whose disease is not well controlled with topical prescription therapies or when those therapies are not recommended.
The use of OPZELURA along with therapeutic biologics, other JAK inhibitors, or strong immunosuppressants such as azathioprine or cyclosporine is not recommended.
It is not known if OPZELURA is safe and effective in children less than 12 years of age with atopic dermatitis.
IMPORTANT SAFETY INFORMATION
OPZELURA is for use on the skin only. Do not use OPZELURA in your eyes, mouth, or vagina.
OPZELURA may cause serious side effects, including:
Serious Infections: OPZELURA contains ruxolitinib. Ruxolitinib belongs to a class of medicines called Janus kinase (JAK) inhibitors. JAK inhibitors are medicines that affect your immune system. JAK inhibitors can lower the ability of your immune system to fight infections. Some people have had serious infections while taking JAK inhibitors by mouth, including tuberculosis (TB), and infections caused by bacteria, fungi, or viruses that can spread throughout the body. Some people have been hospitalized or died from these infections. Some people have had serious infections of their lungs while taking OPZELURA. Your healthcare provider should watch you closely for signs and symptoms of TB during treatment with OPZELURA.
OPZELURA should not be used in people with an active, serious infection, including localized infections. You should not start using OPZELURA if you have any kind of infection unless your healthcare provider tells you it is okay. You may be at a higher risk of developing shingles (herpes zoster) while using OPZELURA.
Increased risk of death due to any reason (all causes): Increased risk of death has happened in people 50 years of age and older who have at least 1 heart disease (cardiovascular) risk factor and are taking a medicine in the class of medicines called JAK inhibitors by mouth.
Cancer and immune system problems: OPZELURA may increase your risk of certain cancers by changing the way your immune system works. Lymphoma and other cancers have happened in people taking a medicine in the class of medicines called JAK inhibitors by mouth. People taking JAK inhibitors by mouth have a higher risk of certain cancers including lymphoma and lung cancer, especially if they are a current or past smoker. Some people have had skin cancers while using OPZELURA. Your healthcare provider will regularly check your skin during your treatment with OPZELURA. Limit the amount of time you spend in the sunlight. Wear protective clothing when you are in the sun and use a broad-spectrum sunscreen.
Increased risk of major cardiovascular events: Increased risk of major cardiovascular events such as heart attack, stroke, or death have happened in people 50 years of age and older who have at least 1 heart disease (cardiovascular) risk factor and taking a medicine in the class of medicines called JAK inhibitors by mouth,especially in current or past smokers.
Blood clots: Blood clots in the veins of your legs (deep vein thrombosis, DVT) or lungs (pulmonary embolism, PE) can happen in some people taking OPZELURA. This may be life-threatening. Blood clots in the vein of the legs (deep vein thrombosis, DVT) and lungs (pulmonary embolism, PE) have happened more often in people who are 50 years of age and older and with at least 1 heart disease (cardiovascular) risk factor taking a medicine in the class of medicines called JAK inhibitors by mouth.
Low blood cell counts: OPZELURA may cause low platelet counts (thrombocytopenia), low red blood cell counts (anemia), and low white blood cell counts (neutropenia). If needed, your healthcare provider will do a blood test to check your blood cell counts during your treatment with OPZELURA and may stop your treatment if signs or symptoms of low blood cell counts happen.
Cholesterol increases: Cholesterol increase has happened in people when ruxolitinib is taken by mouth. Tell your healthcare provider if you have high cholesterol or triglycerides.
Before starting OPZELURA, tell your healthcare provider if you:
After starting OPZELURA:
Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.
The most common side effects of OPZELURA in people treated for atopic dermatitis include: common cold (nasopharyngitis), diarrhea, bronchitis, ear infection, increase in a type of white blood cell (eosinophil) count, hives, inflamed hair pores (folliculitis), swelling of the tonsils (tonsillitis), and runny nose (rhinorrhea).
These are not all of the possible side effects of OPZELURA. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088. You may also report side effects to Incyte Corporation at 1-855-463-3463.
1. National Library of Medicine. How does the immune system work?https://www.ncbi.nlm.nih.gov/books/NBK279364/. Accessed October 3, 2022.
2. Silverberg JI, Gelfand JM, Margolis DJ, et al. Atopic dermatitis in US adults: From population to health care utilization. J Allergy Clin Immunol Pract. 2019;7(5):1524-1532.
3. Journal of Allergy and Clinical Immunology. “The immunology of atopic dermatitis and its reversibility with broad-spectrum and targeted therapies.” April 2017. Accessed October 3, 2022. https://www.jacionline.org/action/showPdf?pii=S0091-6749%2817%2930205-1
4. National Eczema Association. Atopic Dermatitis. https://nationaleczema.org/eczema/types-of-eczema/atopic-dermatitis/. Accessed October 3, 2022.