“While some of my patients may know more about the condition than others, they all understand the persistent itch and discomfort,” says Amy Spizuoco, DO FAOCD FAAD, president of the American Osteopathic College of Dermatology, associate clinical instructor in the Department of Dermatology at The Icahn School of Medicine at Mount Sinai, and editorial board member at Practical Dermatology and Dermatology Times (yes, she knows her stuff).
According to Dr. Spizuoco, AD is a chronic condition caused by an overactivation of the immune system that results in irritated and itchy skin. “It is characterized by inflammation and intense itch, and commonly appears on the face, inside the elbows, or behind the knees,” she says.
So, why is it so vital to get educated about AD? “It’s important for people to understand what’s happening to their skin so they can have more informed, productive conversations with their dermatologist who can help determine a treatment plan that works for their specific needs,” Dr. Spizuoco says. “While AD is a chronic condition that can be difficult to manage, there are treatments available."
Opzelura™ (ruxolitinib) cream 1.5% is a prescription medicine used on the skin (topical) that is FDA-approved for the short-term and non-continuous treatment of mild to moderate AD in patients 12 years and older without weakened immune systems whose disease is uncontrolled with topical prescription therapies, or when those therapies are not recommended.
"For me, Opzelura meets an important need in the treatment of AD, as a non-steroidal topical therapy," says Dr. Spizuoco. "The way it works may make an impact on itch: It targets the JAK-STAT pathway, which is believed to be a source of itch and inflammation in AD." However, the exact way that Opzelura works to reduce signs and symptoms of mild to moderate eczema is not known. Itching for more knowledge? Score it below.
Keep scrolling for three surprising things you might not know about AD, the most common type of eczema.
1. Symptoms can impact people with mild to moderate AD
Whether you have mild, moderate or severe AD, consistently seeing a dermatologist is the best way to help manage your condition. “While the burden of AD can be significant in severe cases, symptoms such as persistent itch and inflammation can also affect people with mild to moderate AD,” she says.
People can experience the symptoms of mild to moderate AD such as inflamed, itchy skin every day. But...
2. AD can be successfully managed
While medication can’t permanently cure AD, building a strong relationship with your dermatologist and determining a treatment plan that can help to address your specific symptoms can help your condition, for example, by reducing itch.
“Treatment options include lifestyle changes and medication, and people may try different approaches,” Dr. Spizuoco says. “Importantly, therapies like Opzelura (ruxolitinib) cream, the first and only FDA-approved topical JAK inhibitor for the treatment of mild to moderate AD, have recently become available, and should be considered for the treatment of certain patients.”
The most common (≥1%) adverse reactions associated with Opzelura are nasopharyngitis (common cold), diarrhea, bronchitis, ear infection, eosinophil (white blood cell) count increased, urticaria (hives), folliculitis (inflamed hair follicles), tonsillitis and rhinorrhea (runny nose). Please see below for Important Safety Information, including Boxed Warnings for serious infections, mortality, malignancy, major adverse cardiovascular events and thrombosis.
3. AD is not contagious
Yup, this misconception still lingers around people with AD. “AD is an immune-mediated condition caused by an overactivation of the immune system," Dr. Spizuoco says. So, to be clear, no, AD is not contagious and can’t be caught.
However, there are things that can trigger AD flare-ups in people who already have the condition, like stress, allergies, and environmental factors. The important thing to remember? "For anyone dealing with AD, there is hope," says Dr. Spizuoco. "It’s also important to be an advocate for your own health. If you haven’t found relief, you don’t have to give up—reach out to a dermatologist to revisit the conversation and discuss another approach." Consider yourself empowered.
WHAT IS OPZELURA USED FOR?
OPZELURA (ruxolitinib) cream 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 ABOUT OPZELURA
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:
• have an infection, are being treated for one, or have had an infection that does not go away or keeps coming back
• have diabetes, chronic lung disease, HIV, or a weak immune system
• have TB or have been in close contact with someone with TB
• have had shingles (herpes zoster)
• have or have had hepatitis B or C
• live, have lived in, or have traveled to certain parts of the country (such as the Ohio and Mississippi River valleys and the Southwest) where there is an increased chance for getting certain kinds of fungal infections. These infections may happen or become more severe if you use OPZELURA. Ask your healthcare provider if you do not know if you have lived in an area where these infections are common.
• think you have an infection or have symptoms of an infection such as:fever, sweating, or chills, muscle aches, cough or shortness of breath, blood in your phlegm, weight loss, warm, red, or painful skin or sores on your body, diarrhea or stomach pain, burning when you urinate or urinating more often than usual, feeling very tired.
• have ever had any type of cancer, or are a current or past smoker
• have had a heart attack, other heart problems, or a stroke
• have had blood clots in the veins of your legs or lungs in the past
• have high cholesterol or triglycerides
• have or have had low white or red blood cell counts
• are pregnant or plan to become pregnant. It is not known if OPZELURA will harm your unborn baby. There is a pregnancy exposure registry for individuals who use OPZELURA during pregnancy. The purpose of this registry is to collect information about the health of you and your baby. If you become exposed to OPZELURA during pregnancy, you and your healthcare provider should report exposure to Incyte Corporation at 1-855-463-3463.
• are breastfeeding or plan to breastfeed. It is not known if OPZELURA passes into your breast milk. Do not breastfeed during treatment with OPZELURA and for about 4 weeks after the last dose.
After starting OPZELURA:
• Call your healthcare provider right away if you have any symptoms of an infection. OPZELURA can make you more likely to get infections or make worse any infections that you have.
• Get emergency help right away if you have any symptoms of a heart attack or stroke while using OPZELURA, including:
- discomfort in the center of your chest that lasts for more than a few minutes, or that goes away and comes back
- severe tightness, pain, pressure, or heaviness in your chest, throat, neck, or jaw
- pain or discomfort in your arms, back, neck, jaw, or stomach
- shortness of breath with or without chest discomfort
- breaking out in a cold sweat nausea or vomiting
- feeling lightheaded
- weakness in one part or on one side of your body
- slurred speech
• Tell your healthcare provider right away if you have any signs and symptoms of blood clots during treatment with OPZELURA, including: swelling, pain, or tenderness in one or both legs, sudden, unexplained chest or upper back pain, or shortness of breath or difficulty breathing.
• Tell your healthcare provider right away if you develop or have worsening of any symptoms of low blood cell counts, such as: unusual bleeding, bruising, tiredness, shortness of breath, or fever.
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.
OPZELURA is a trademark of Incyte.
© 2022, Incyte Corporation. MAT-OPZ-01010 10/22
Loading More Posts...