Opzelura ad

Opzelura is also approved in the U.S. for the topical short-term and non-continuous chronic treatment of mild to moderate atopic dermatitis (AD) in non-immunocompromised patients 12 years of age ...

nausea. night sweats. pain, redness, or swelling in the arm or leg. pain or discomfort in the arms, jaw, back, or neck. pains in the chest, groin, or legs, especially calves of the legs. persistent non-healing sore. pink growth. pinpoint red spots on the skin. reddish patch or irritated area.OPZELURA is indicated for the topical short-term and non-continuous chronic treatment of mild to moderate atopic dermatitis in non-immunocompromised adult and pediatric patients 12 years of age and older whose disease is not adequately controlled with topical prescription therapies or when those therapies are not advisable.. Limitations of Use: …Ruxolitinib cream 1.5% (OPZELURA™) is a topical formulation of ruxolitinib, a potent, selective inhibitor of Janus kinase (JAK)1 and JAK2. The targeting of these kinases is associated with therapeutic benefits in patients with atopic dermatitis (AD). In two identically designed, multinational, phase III studies in patients aged ≥ 12 years with mild …Opzelura is also approved in the U.S. for the topical short-term and non-continuous chronic treatment of mild to moderate atopic dermatitis (AD) in non-immunocompromised patients 12 years of age ...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 ...At Week 8, 53.8% of patients taking OPZELURA achieved clear or almost clear results vs. 15.1% for vehicle in TRuE-AD1. In TRuE-AD2, 51.3% of patients taking OPZELURA achieved clear or almost clear results vs. 7.6% for vehicle. This demonstrates a 44% improvement over vehicle. 1-3

2) Experts outline strategies for patient conversations around the black box warning. Janus kinase (JAK) inhibitors continue to make headlines in the pipeline and armamentarium for atopic dermatitis (AD) treatment. An FDA-issued black box warning, however, creates a challenge for dermatologists, who must explain the risks and benefits …Choose A Better Way To Measure TV ROAS. Watch, interact and learn more about the songs, characters, and celebrities that appear in your favorite Opzelura TV Commercials. Watch the commercial, share it with friends, then discover more great Opzelura TV commercials on iSpot.tv.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. The most common side effects of OPZELURA in people treated for nonsegmental vitiligo include: 1-800-FDA-1088 1-855-463-3463.How Supplied - OPZELURA is a white to off-white cream containing 1.5% ruxolitinib and is supplied in 60 g and 100 g tubes. 60 g tube: NDC 50881-007-05 - 100 g tube: NDC 50881-007-07 - Storage and ... Advise the patient or caregivers to read the FDA-approved patient labeling (Medication Guide).In today’s digital age, businesses have more opportunities than ever to reach their target audience. One effective way to do so is through creating your own ad. While it may seem d...THE OPZELURACOPAYSAVINGSPROGRAM. ELIGIBLE* PATIENTS. WITH COMMERCIAL. INSURANCE MAY PAY. AS LITTLE AS $0 PER. TUBE FOR OPZELURA. Through the OPZELURA copay savings program, you may be able to pay as little as $0 on every tube. There are 3 ways to get a card—download your card directly, send it to your email, or get it in a text! OPZELURA is for use on the skin only. Do not use OPZELURA in your eyes, mouth, or vagina. Use OPZELURA exactly as your healthcare provider tells you. Apply a thin layer of OPZELURA 2 times a day to affected areas. Do not use more than one 60 gram tube each week or more than one 100 gram tube every 2 weeks. Ask your healthcare provider if you ... By using this copay savings card at participating pharmacies, eligible patients with commercial prescription drug insurance coverage for OPZELURA may pay as little as $0 per tube. Eligible patients whose commercial insurance plan does not cover OPZELURA will pay $35 per prescription and will only be able to redeem this offer at certain ...

Opzelura is a prescription drug approved to treat atopic dermatitis and vitiligo in certain people. Learn about cost, side effects, dosage, alternatives, and more.Opzelura at the 1.5% strength currently boasts the strongest ... Vtama’s data across a wider age group looked comparable to Opzelura at the 0.75% strength in the previous TRuE-AD trials in older ...Opzelura is a prescription drug approved to treat atopic dermatitis and vitiligo in certain people. Learn about cost, side effects, dosage, alternatives, and more.About Press Copyright Contact us Creators Advertise Developers Terms Privacy Policy & Safety How YouTube works Test new features NFL Sunday Ticket Press Copyright ...In September 2021, Opzelura was approved by the FDA for the topical short-term and non-continuous chronic treatment of mild to moderate atopic dermatitis (AD) in non-immunocompromised patients 12 ...Dec 4, 2023 · Mandy Moore meet Morgan Freeman. While Moore is a major get for Incyte, she isn’t the first A-lister the company has enlisted to communicate Opzelura’s benefits. In March, the company rolled out ads narrated by Academy Award-winner Morgan Freeman, focused on the use of Opzelura to treat another skin condition, vitiligo.

How to fold money flower.

Aug 12, 2023 · Opzelura Commercial Actress. August 12, 2023 by Olivia. In the world of exciting TV ads, one that recently caught many people’s interest is the Opzelura Commercial Actress, she was featured in the ad named ‘Imagine This.’. Viewers have been drawn in by the vivid energy and compelling performer depicted in this advertisement, sparking ... Pharma. Marketing. In­cyte adds first Opzelu­ra brand TV com­mer­cial, and a fa­mous voice, to its vi­tili­go ef­forts. Beth Snyder Bulik. Senior Editor. A well-known celebri­ty voice is...INDICATION. OPZELURA is indicated for the topical treatment of nonsegmental vitiligo in adult and pediatric patients 12 years of age and older. Limitations of Use: Use of OPZELURA in combination with therapeutic biologics, other JAK inhibitors, or potent immunosuppressants such as azathioprine or cyclosporine is not recommended.Ads can be annoying and intrusive, especially when they pop up while you’re trying to browse the web. Fortunately, there are a few easy ways to block ads on Chrome for free. Here’s...

Among patients who applied 1.5% ruxolitinib cream—the generic name for Opzelura—twice daily for the entire study period, roughly 50% saw at least 75% improvement on a scoring index for facial ...OPZELURA is the first-ever prescription treatment approved by the FDA for vitiligo repigmentation: It's proven to help significantly restore some pigment over time in some patients. It's a steroid-free topical cream that you can apply yourself. It's proven to help restore pigment on the face and body (up to 10% body surface area). Advise women not to breastfeed during treatment with OPZELURA and for approximately four weeks after the last dose (approximately 5-6 elimination half-lives). Please see Full Prescribing Information, including Boxed Warning, and Medication Guide for OPZELURA. See the OPZELURA® treatment difference in people with mild to moderate atopic dermatitis. Aug 9, 2023 ... 122 likes, 4 comments - blocla on August 9, 2023: "Jump into Summer with glowing skin! Check out this new Opzelura commercial featuring ...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). 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. Dec 4, 2023 · Mandy Moore meet Morgan Freeman. While Moore is a major get for Incyte, she isn’t the first A-lister the company has enlisted to communicate Opzelura’s benefits. In March, the company rolled out ads narrated by Academy Award-winner Morgan Freeman, focused on the use of Opzelura to treat another skin condition, vitiligo. SAVINGS CARD. Eligible* patients with commercial insurance may pay as little as $0 per tube for OPZELURA. *Terms & Conditions apply. See ...The FDA has approved ruxolitinib (Opzelura; Incyte), a topical selective Janus kinase (JAK)1/JAK2 inhibitor, for the treatment of mild to moderate atopic …

Indication and Usage. OPZELURA is a prescription medicine used on the skin (topical) for 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 ...

Oct 21, 2021 ... In a phase 3 clinical study, Opzelura treatment significantly reduced skin inflammation and itching associated with AD. And reducing itching can ...Check out Opzelura's 60 second TV commercial, 'Imagine This' from the Rx: Psoriasis, Shingles, Skin & Nails industry. Keep an eye on this page to learn about the songs, characters, and celebrities appearing in this TV commercial. Share it with friends, then discover more great TV commercials on iSpot.tv. Published. July 17, 2023.Get a Dose of PracticalDermatology in Your Inbox and Practice Smarter Medicine. Stay current with the best on medical educationMaximum 60 grams per week. Stop using when signs and symptoms (e.g., itch, rash, and redness) of AD resolve. If signs and symptoms do not improve within 8 weeks, patients should be re-examined by their health care provider. Cream: 15 mg of ruxolitinib per gram (1.5%) in 60-gram tubes.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 ...In today’s digital age, businesses have more opportunities than ever to reach their target audience. One effective way to do so is through creating your own ad. While it may seem d...Opzelura is the first FDA-approved prescription treatment for vitiligo repigmentation. It is a topical cream that the patient applies to the affected area (s) twice per day. According to their website, Opzelura: Is proven to help significantly restore some pigment over time in some patients.

Mullet front view.

Yuzu xci vs nsp.

Vitiligo is an autoimmune disorder that leads to the loss of skin pigmentation. A recent study shows a medicated cream called ruxolitinib is extremely effective in about one-third of patients. The ...If you need a second tube of OPZELURA, your doctor must first appeal the initial coverage denial with your insurance plan. *. Terms and Conditions apply. Terms of this Program may change at any time. Call IncyteCARES for OPZELURA. at 1-800-583-6964, Monday through Friday, 8 AM –8 PM ET. Patients were randomized to monotherapy with OPZELURA, ruxolitinib cream 0.75%, or vehicle twice daily for 8 weeks. 1. In a 44-week extension study, patients initially randomized to OPZELURA in the TRuE-AD clinical trials remained on their regimen. Patients initially randomized to vehicle were rerandomized 1:1 to ruxolitinib cream 0.75% or ... For the topical treatment of nonsegmental vitiligo in adult and pediatric patients 12 years of age and older. 1. Limitations of Use: Use of OPZELURA in combination with therapeutic biologics, other JAK inhibitors, or potent immunosuppressants such as azathioprine or cyclosporine is not recommended. The Opzelura On Trac patient support program ...AD 2) evaluating the safety and ecacy of Opzelura in more than 1,200 adolescents and adults with mild to moderate AD. Results from the studies showed patients experienced signicantly clearer skin and itch reduction when treated with Opzelura cream 1.5% twice daily (BID), compared to vehicle (non-medicated cream):Nevertheless, the strong uptake of Opzelura (ruxolitinib) cream in atopic dermatitis (AD) and vitiligo in the United States propelled the company to post 9% revenue growth in the first three quarters.OPZELURA is thought to inhibit IFN-γ mediated JAK-STAT signaling, a key driver of depigmentation in vitiligo1-3. OPZELURA is a topical JAK inhibitor that regulates IFN- γ mediated JAK-STAT signaling, which is thought to reduce CD8+ T-cell mediated destruction of melanocytes. 1,2,6,8. This may create a more stable environment enabling the ...OPZELURA is a topical JAK inhibitor designed to target the signaling of key cytokines believed to be critical to the Th2 response in AD, which contribute to 1-5: Itch and inflammation: IL-4, IL-13, IL-31, and TSLP. JAKs are intracellular signaling enzymes that act downstream of many inflammatory cytokines involved in AD pathogenesis. 2.The ad released by Opzelura Cream in July 2023 is simple and effective: a beautiful actress talking about the benefits of this product, showing herself in daily situations we can all relate to. Up to the point that many wanted to know who the testimonial is: her name is Kristen Vaganos, and today, we are going to discover more about her.OPZELURA Market Drug Insight and Market Forecast - 2032. “OPZELURA Market Drug Insight and Market Forecast - 2032” report provides comprehensive insights about OPZELURA for Atopic Dermatitis (AD) in the seven major markets. A detailed picture of the OPZELURA for atopic dermatitis in the 7MM, i.e., United States, EU5 (Germany, France, …A TOPICAL, NON-STEROIDAL MONOTHERAPY 1. AS-NEEDED MANAGEMENT OF AD FLARE-UPS 1,2. OPZELURA is not an injectable or systemic—it’s an elegant, non … ….

Opzelura Commercial 2024. Food and drug administration (fda). Opzelura is a prescription medicine used on the skin (topical) for the treatment of a type of vitiligo called nonsegmental vitiligo in adults and children 12 years of age and older. Kristen has been active in the movie industry for years and starred in. Opzelura is aBy Nick Paul Taylor Oct 12, 2023 11:38am. Incyte Opzelura eczema atopic dermatitis. Incyte has activated star power for its latest Opzelura ad campaign, enlisting the actor and singer Mandy...Check with your physician for additional information about side effects. Dosage for Opzelura. Apply a thin layer of Opzelura twice daily to affected areas of up to 20% body surface area. Do not use more than 60 grams per week. Opzelura is for topical use only. Opzelura is not for ophthalmic, oral, or intravaginal use. OPZELURA is a prescription medicine used on the skin (topical) for 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. How Supplied - OPZELURA is a white to off-white cream containing 1.5% ruxolitinib and is supplied in 60 g and 100 g tubes. 60 g tube: NDC 50881-007-05 - 100 g tube: NDC 50881-007-07 - Storage and ... Advise the patient or caregivers to read the FDA-approved patient labeling (Medication Guide).About Press Copyright Contact us Creators Advertise Developers Terms Privacy Policy & Safety How YouTube works Test new features NFL Sunday Ticket Press Copyright ... Finding your moment. Atopic dermatitis (AD), the most common form of eczema, affects 21 million people in the U.S. aged 12 years and older. While every person’s experience with eczema is unique, there are defining moments in everyone's journey – from realizing the need for relief from symptoms to advocating for yourself and finding a treatment that’s right for you. At Week 8, 53.8% of patients taking OPZELURA achieved clear or almost clear results vs. 15.1% for vehicle in TRuE-AD1. In TRuE-AD2, 51.3% of patients taking OPZELURA achieved clear or almost clear results vs. 7.6% for vehicle. This demonstrates a 44% improvement over vehicle. 1-3The FDA has approved ruxolitinib (Opzelura, Incyte) cream for short-term, non-continuous treatment of mild to moderate atopic dermatitis in non …HELP WITHYOUR APPEAL. Your doctor must submit an appeal to your insurance plan within 90 days of enrollment to continue participation in the Program. *. Terms and Conditions apply. Terms of this Program may change at any time. Call IncyteCARES for OPZELURA. at 1-800-583-6964, Monday through Friday, 8 AM –8 PM ET. Opzelura ad, Opzelura is the first FDA-approved pharmacologic treatment to address repigmentation in vitiligo patients. Opzelura is applied twice a day to affected areas of up to 10% of the body’s surface..., Jul 11, 2023 · Opzelura is also approved in the U.S. for the topical short-term and non-continuous chronic treatment of mild to moderate atopic dermatitis (AD) in non-immunocompromised patients 12 years of age and older whose disease is not adequately controlled with topical prescription therapies, or when those therapies are not advisable. Use of Opzelura in ... , Indication and Usage. OPZELURA is a prescription medicine used on the skin (topical) for 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 ..., 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 ..., As for the 60g commercial dose of Opzelura, the company has stopped distribution from the problematic batch. It doesn’t expect a recall now, Evercore ISI analyst Maneka Mirchandaney said in a ..., May 1, 2023 · SCRATCH-AD is a single-site Phase 2 open-label, single-arm study evaluating the safety and efficacy of Opzelura® (ruxolitinib) cream 1.5% in adult patients (age 18 to 65 years) with atopic dermatitis (AD), with a particular focus on understanding the short-term clinical benefits of Opzelura to control pruritus (itching) and reduce AD severity. , Opzelura is a prescription drug used to treat eczema and vitiligo in certain adults and children. It comes as a cream that you’ll apply to the affected areas of your skin. Opzelura works by ..., AD 2) evaluating the safety and ecacy of Opzelura in more than 1,200 adolescents and adults with mild to moderate AD. Results from the studies showed patients experienced signicantly clearer skin and itch reduction when treated with Opzelura cream 1.5% twice daily (BID), compared to vehicle (non-medicated cream): , Indication and Usage. OPZELURA is a prescription medicine used on the skin (topical) for 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 ..., Objective: To evaluate 8-week efficacy and safety in 2 phase 3 studies of RUX cream in patients with AD. Methods: Topical Ruxolitinib Evaluation in Atopic Dermatitis Study 1 ( NCT03745638 ) and Study 2 ( NCT03745651 ) enrolled patients aged ≥12 years with AD for ≥2 years, an Investigator's Global Assessment score of 2/3, and 3%-20% affected ..., Sep 22, 2021 ... The FDA approval was based on the Topical Ruxolitinib Evaluation in Atopic Dermatitis (TRuE-AD) clinical trial program, which consisted of 1200 ..., OPZELURA . Generic or Proper Name: ruxolitinib . Sponsor: Incyte Corporation . Approval Date: 9/21/21 . Indication: For the topical short-term and non-continuous chronic treatment of mild to moderate atopic dermatitis in non-immunocompromised patients 12 years of age and older whose disease is not adequately controlled with topical, Opzelura side effects. Opzelura may cause serious side effects, including: See Important information. 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 ..., Pharma. Marketing. In­cyte adds first Opzelu­ra brand TV com­mer­cial, and a fa­mous voice, to its vi­tili­go ef­forts. Beth Snyder Bulik. Senior Editor. A well-known celebri­ty voice is..., OPZELURA es una crema tópica de aplicación localizada que actúa sobre la vía JAK-STAT, que se cree que ayuda a regular la señalización detrás de la inflamación que causa la picazón del eczema. No se comprende por completo la manera exacta en que OPZELURA actúa para reducir los signos y síntomas del eczema., The OPZELURA Commercial Bridge Program supplies limited quantities of OPZELURA to eligible* patients who have received a PA denial. Learn more about eligibility and how to enroll. See Program details *Terms and Conditions apply. Terms of the commercial bridge program may change at any time., Opzelura Commercial #2 (2023), "Imagine This", Instruct patients to apply a thin layer of OPZELURA twice daily to affected areas of up to 20% body surface area. Do not use more than 60 grams per week. OPZELURA is for topical use only. OPZELURA is not for ophthalmic, oral, or intravaginal use. Stop using when signs and symptoms (e.g., itch, rash, and redness) of atopic dermatitis resolve., OPZELURA is a single steroid-free cream applied directly to the areas of the skin where you have eczema,* and seamlessly goes on to help reduce itch right where it’s needed. Use OPZELURA as directed by your healthcare provider. *OPZELURA is for use on the skin only. Do not use OPZELURA in your eyes, mouth, or vagina., Cherkasova Alie /AdobeStock. Incyte announced today the positive topline results from its phase 3 TRuE-AD3 (NCT04921969) trial evaluating the safety and efficacy of ruxolitinib cream (Opzelura) in pediatric patients aged 2 to 12 years with atopic dermatitis. 1 The randomized, vehicle-controlled, pivotal phase 3 trial met its primary endpoint of ..., Indication and Usage. OPZELURA is a prescription medicine used on the skin (topical) for 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 ..., SCRATCH-AD is a single-site Phase 2 open-label, single-arm study evaluating the safety and efficacy of Opzelura ® (ruxolitinib) cream 1.5% in adult patients (age 18 to 65 years) with atopic dermatitis (AD), with a particular focus on understanding the short-term clinical benefits of Opzelura to control pruritus (itching) and reduce AD severity., 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., Nothing is a London-based consumer technology company founded by Carl Pei and team. Nothing wants to inspire people to believe in the positive potential of technology again. , Sep 26, 2023 · The ad released by Opzelura Cream in July 2023 is simple and effective: a beautiful actress talking about the benefits of this product, showing herself in daily situations we can all relate to. Up to the point that many wanted to know who the testimonial is: her name is Kristen Vaganos, and today, we are going to discover more about her. , Patients were randomized to monotherapy with OPZELURA, ruxolitinib cream 0.75%, or vehicle twice daily for 8 weeks. 1. In a 44-week extension study, patients initially randomized to OPZELURA in the TRuE-AD clinical trials remained on their regimen. Patients initially randomized to vehicle were rerandomized 1:1 to ruxolitinib cream 0.75% or ... , Oct 20, 2022 ... Commercial insurers and Medicare have been covering ruxolitinib cream, Rosmarin said, now that there's "broad agreement in the medical ..., Finding the perfect nanny for your family can be a daunting task. With so many candidates out there, it’s important to create an effective nanny wanted ad that will attract the rig..., 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. , 2 of 4 PRESCRIPTION AND ENROLLMENT FORM OR OPZELURA TO SUBMIT, COMPLETE AND A HIS OR O 1-77-01-384. Provid op h HIPAA uthorizatio ou atien o hei ecords. FOR ASSISTANCE OR ADDITIONAL INFORMATION, CALL 1˛800˛9321720, MONDAY FRIDAY 8 ˙ˆ TO 8 ˇˆ E. By signing this form, you are giving your permission to …, Today the eczema community is one step closer to having a new treatment option. The U.S. Food and Drug Administration (FDA) has approved Opzelura (ruxolitinib) cream, from manufacturer Incyte, for the short-term and non-continuous chronic treatment of mild to moderate atopic dermatitis (AD) in non-immunocompromised patients 12 years of …, By using this copay savings card at participating pharmacies, eligible patients with commercial prescription drug insurance coverage for OPZELURA may pay as little as $0 per tube. Eligible patients whose commercial insurance plan does not cover OPZELURA will pay $35 per prescription and will only be able to redeem this offer at certain ..., Opzelura is approved in the U.S. for the topical treatment of non-segmental vitiligo in patients 12 years of age and older and for the topical short-term and non-continuous chronic treatment of mild to moderate atopic dermatitis (AD) in non-immunocompromised patients 12 years of age and older whose disease is not adequately controlled with ...