Incyte Furthers Commitment to People Living with Atopic Dermatitis by Sharing Additional Patient Experiences as part of its Moments of Clarity Program
Incyte (Nasdaq:INCY) has expanded its Moments of Clarity program, an educational initiative highlighting stories of people living with mild to moderate atopic dermatitis (AD). The program now features additional patient perspectives, including Dr. Sandra Lee (known as Dr. Pimple Popper) and Emily, a mom of three. They share their experiences with AD and finding relief with Opzelura® (ruxolitinib) cream 1.5%.
Opzelura is a nonsteroidal, twice-daily cream for short-term and non-continuous treatment of mild to moderate eczema in certain people 12 and older. In a pivotal clinical trial, 54% of patients had clear to almost clear skin at 8 weeks, and 52% had a significant reduction in itch. The program aims to empower others to seek appropriate treatment and raise awareness about AD, which affects over 21 million people aged 12 and older in the U.S.
Incyte (Nasdaq:INCY) ha ampliato il suo programma Momenti di Chiarezza, un'iniziativa educativa che evidenzia le storie di persone che vivono con dermatite atopica (AD) da lieve a moderata. Il programma ora include ulteriori esperienze dei pazienti, tra cui quella della Dr.ssa Sandra Lee (conosciuta come Dr. Pimple Popper) e di Emily, una mamma di tre figli. Condividono le loro esperienze con l'AD e come hanno trovato sollievo con la crema Opzelura® (ruxolitinib) 1,5%.
Opzelura è una crema non steroidea, da applicare due volte al giorno per il trattamento a breve termine e non continuativo della dermatite atopica da lieve a moderata in certe persone di età pari o superiore a 12 anni. In uno studio clinico cruciale, il 54% dei pazienti ha ottenuto una pelle chiara o quasi chiara dopo 8 settimane, mentre il 52% ha mostrato una significativa riduzione del prurito. Il programma ha l'obiettivo di incoraggiare altri a cercare il trattamento appropriato e aumentare la consapevolezza sull'AD, che colpisce oltre 21 milioni di persone di età pari o superiore a 12 anni negli Stati Uniti.
Incyte (Nasdaq:INCY) ha ampliado su programa Momentos de Claridad, una iniciativa educativa que destaca las historias de personas que viven con dermatitis atópica (AD) leve a moderada. El programa ahora cuenta con perspectivas adicionales de pacientes, incluyendo a la Dr. Sandra Lee (conocida como Dr. Pimple Popper) y a Emily, una madre de tres. Comparten sus experiencias con la AD y cómo encontraron alivio con la crema Opzelura® (ruxolitinib) 1.5%.
Opzelura es una crema no esteroidea, de uso dos veces al día para el tratamiento a corto plazo y no continuo de eczema leve a moderado en ciertas personas de 12 años o más. En un ensayo clínico pivotal, el 54% de los pacientes tuvo piel clara o casi clara a las 8 semanas, y el 52% tuvo una reducción significativa en la picazón. El programa tiene como objetivo empoderar a otros para que busquen el tratamiento adecuado y aumentar la concienciación sobre la AD, que afecta a más de 21 millones de personas de 12 años o más en los EE. UU.
Incyte (Nasdaq:INCY)는 명쾌한 순간 프로그램을 확장했습니다. 이는 경증에서 중등도의 아토피 피부염(AD)을 앓고 있는 사람들의 이야기를 강조하는 교육 이니셔티브입니다. 이 프로그램은 이제 Dr. Sandra Lee (일명 Dr. Pimple Popper)와 세 아이의 엄마인 Emily를 포함한 추가 환자 관점을 특징으로 합니다. 그들은 AD와 Opzelura® (ruxolitinib) 크림 1.5%로의 완화 경험을 공유합니다.
Opzelura는 특정 12세 이상의 사람들을 위한 비스테로이드성 크림, 하루 두 번 사용이 가능한 경증에서 중등도 습진의 단기적이고 간헐적인 치료제입니다. 중대한 임상시험에서 54%의 환자가 8주 동안 깨끗하거나 거의 깨끗한 피부를 가졌습니다, 그리고 52%가 가려움증의 상당한 감소를 경험했습니다. 이 프로그램은 다른 사람들이 적절한 치료를 찾도록 도와주고 AD에 대한 인식을 제고하는 것을 목표로 하며, 미국에서는 12세 이상 2100만 명 이상이 영향을 받고 있습니다.
Incyte (Nasdaq:INCY) a élargi son programme Moments de Clarté, une initiative éducative mettant en avant les histoires de personnes vivant avec dermatite atopique (AD) légère à modérée. Le programme présente désormais des témoignages supplémentaires de patients, y compris le Dr Sandra Lee (connue sous le nom de Dr. Pimple Popper) et Emily, une mère de trois enfants. Ils partagent leurs expériences avec l'AD et la façon dont ils ont trouvé un soulagement grâce à la crème Opzelura® (ruxolitinib) 1,5%.
Opzelura est une crème non stéroïdienne, à appliquer deux fois par jour pour un traitement à court terme et non continu de l'eczéma léger à modéré chez certaines personnes de 12 ans et plus. Dans un essai clinique pivot, 54% des patients avaient une peau claire ou presque claire après 8 semaines, et 52% ont montré une réduction significative des démangeaisons. Le programme vise à encourager d'autres à rechercher un traitement approprié et à sensibiliser sur l'AD, qui touche plus de 21 millions de personnes de 12 ans et plus aux États-Unis.
Incyte (Nasdaq:INCY) hat sein Momente der Klarheit-Programm erweitert, eine Bildungsinitiative, die Geschichten von Menschen mit leichter bis moderater atopischer Dermatitis (AD) hervorhebt. Das Programm bietet nun zusätzliche Patientenerfahrungen, einschließlich der Dr. Sandra Lee (bekannt als Dr. Pimple Popper) und Emily, einer Mutter von drei Kindern. Sie teilen ihre Erfahrungen mit AD und wie sie mit Opzelura® (ruxolitinib) Creme 1,5% Linderung gefunden haben.
Opzelura ist eine nichtsteroidale Creme, die zweimal täglich angewendet wird für die kurzfristige und nicht kontinuierliche Behandlung von leichtem bis moderatem Ekzem bei bestimmten Personen ab 12 Jahren. In einer entscheidenden klinischen Studie hatten 54 % der Patienten nach 8 Wochen eine klare oder nahezu klare Haut, und 52 % hatten eine signifikante Reduzierung des Juckreizes. Das Programm zielt darauf ab, andere zu ermutigen, die angemessene Behandlung zu suchen und das Bewusstsein für AD zu schärfen, die über 21 Millionen Menschen ab 12 Jahren in den USA betrifft.
- Expansion of educational program featuring real patient experiences
- Clinical trial results show 54% of patients had clear to almost clear skin at 8 weeks
- 52% of patients experienced significant itch reduction in clinical trials
- Large target market with over 21 million potential patients aged 12 and older in the U.S.
- Opzelura is only for short-term and non-continuous treatment
- Use of Opzelura with biologics, other JAK inhibitors, or potent immunosuppressants is not recommended
- Product carries boxed warnings for serious infections, increased risk of death, lymphoma and other cancers, major cardiovascular events, and blood clots
Board-certified dermatologist, Dr. Sandra Lee, widely known as Dr. Pimple Popper, among others, details her journey with mild-moderate atopic dermatitis, the most common form of eczema, and her experience on Opzelura® (ruxolitinib) cream
Dr. Sandra Lee partners with Incyte on Moments of Clarity program to encourage those with eczema to see a healthcare provider about treatment (Photo: Business Wire)
In the new program content, each patient shares defining moments throughout their journeys including how they finally found relief with Opzelura® (ruxolitinib) cream
“While many people know me as a dermatologist from my TV show, most probably don’t know that I live with eczema and have struggled with symptoms like persistent itch and skin inflammation throughout my life,” said Dr. Lee. “I started using Opzelura, a non-steroidal topical option, to treat my eczema flares, which helped alleviate some of my worst symptoms like itch. In the pivotal clinical trial for mild to moderate AD,
AD – the most common type of eczema – is a chronic condition characterized by inflammation of the skin, which can manifest as persistent itch, dry and scaly patches or red lesions on the body1. AD affects more than 21 million people aged 12 years and older in the
“We understand the impact eczema can have on daily life, which furthers the need for patients to find a treatment to address their individual symptoms,” said Matteo Trotta, Executive Vice President, General Manager,
To hear more visit MyMomentsofClarity.com.
All individuals were compensated for their participation.
About Opzelura® (ruxolitinib) Cream
Opzelura® (ruxolitinib) cream, a novel cream formulation of Incyte’s selective JAK1/JAK2 inhibitor ruxolitinib, approved by the
Incyte has worldwide rights for the development and commercialization of ruxolitinib cream, marketed in
Opzelura is a registered trademark of Incyte.
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:
- 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).
The most common side effects of OPZELURA in people treated for nonsegmental vitiligo include: acne at the application site, itching at the application site, common cold (nasopharyngitis), headache, urinary tract infection, redness at the application site, and fever.
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.
INDICATIONS AND USAGE
OPZELURA is a prescription medicine used on the skin (topical) for:
- 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 treatment of a type of vitiligo called nonsegmental vitiligo in adults and children 12 years of age and older
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 or nonsegmental vitiligo.
Please see the Full Prescribing Information, including Boxed Warning, and Medication Guide for OPZELURA.
About Incyte Dermatology
Incyte’s science-first approach and expertise in immunology has formed the foundation of the company. Today, we are building on this legacy as we discover and develop innovative dermatology treatments to bring solutions to patients in need.
We strive to identify and develop therapies to modulate immune pathways driving uncontrolled inflammation to help restore normal immune function and bring the body closer to homeostasis. Specifically, our efforts in dermatology are focused on a number of immune-mediated dermatologic conditions with a high unmet medical need, including atopic dermatitis, vitiligo, hidradenitis suppurativa, lichen planus, lichen sclerosus and prurigo nodularis
To learn more, visit the Dermatology section of Incyte.com.
About Incyte
A global biopharmaceutical company on a mission to Solve On., Incyte follows the science to find solutions for patients with unmet medical needs. Through the discovery, development and commercialization of proprietary therapeutics, Incyte has established a portfolio of first-in-class medicines for patients and a strong pipeline of products in Oncology and Inflammation & Autoimmunity. Headquartered in
For additional information on Incyte, please visit Incyte.com or follow us on social media: LinkedIn, X, Instagram, Facebook, YouTube.
Forward-Looking Statements
Except for the historical information set forth herein, the matters set forth in this press release, including statements regarding the partnership between Incyte and Dr. Sandra Lee Incyte’s goal of improving the lives of patients, whether and when Opzelura might provide a successful treatment option for patients with atopic dermatitis, and Incyte’s dermatology program generally, contain predictions, estimates and other forward-looking statements.
These forward-looking statements are based on Incyte’s current expectations and subject to risks and uncertainties that may cause actual results to differ materially, including unanticipated developments in and risks related to: unanticipated delays; further research and development and the results of clinical trials possibly being unsuccessful or insufficient to meet applicable regulatory standards or warrant continued development; the ability to enroll sufficient numbers of subjects in clinical trials; determinations made by the FDA and other regulatory authorities outside of
1 National Eczema Association. What is atopic dermatitis? https://nationaleczema.org/eczema/types-of-eczema/atopic-dermatitis/
View source version on businesswire.com: https://www.businesswire.com/news/home/20241009443934/en/
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Source: Incyte
FAQ
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