Second Biologic To Make Entry For Moderate
The FDAs approval of dupilumab, already approved for severe eczema, for asthma makes it the second biologic for the incurable lung disease.
The FDAs approval of dupilumab, already approved for severe eczema, for asthma makes it the second biologic for the incurable lung disease. Dupilumab, branded as Dupixent by Regeneron and Sanofi, was cleared as an add-on maintenance treatment for moderate to severe asthma in patients 12 years of age and older.
Dupilumab is more expensive than omalizumab, but it works on additional pathways than omalizumab and can also be administered at home, while omalizumab must be given in a doctors office.
In its press release, the companies said the wholesale acquisition cost will remain unchanged for the new indication.
Dupilumab has a WAC of $37,000 a year, up from $30,000 when it first launched for eczema. The companies raised the price effective June 29.
On GoodRx, a prescription pricing website for consumers, the average retail price for dupixent was $3274.11 for two 150 mg/ml syringes. For omalizumab, the price was $1317.40 for one 150 mg vial.
Dupilumab is the first drug to target the interleukin-4 IL-4 and IL-13 pathways in type 2, or eosinophilic asthma. Last year, the FDA approved dupilumab for the treatment of adults with moderate-to-severe atopic dermatitis whose condition is not properly controlled with topical therapies.
AJMC®: What are your expectations for payer pickup for this?
How I Learned About This Crazy Dupixent Side Effect
A wonderful client of mine has been really miserable with TSW for a while now and was seeking some relief so that she could be a better mom to her kids.
We discussed her starting Dupixent to see if it could help lower the severity of her symptoms.
But we didnt anticipate that shed end up with a bright red, inflamed and itchy face, neck and chest while everything else seemed to heal up.
Her prescribing dermatologist was stumped and wasnt sure what was going on. My client shared her concern that it could potentially be coming from Dupixent from what shed read online.
So her doctor stopped her on the medication.
A few weeks later, her doctor returned from a medical conference and mentioned to her that information was presented at this conference that her face and neck flare-up could be connected to a fungal problem, but refused to treat her since my client had stopped Dupixent.
This info was relayed to me and I started searching for research online about this.
How Does Dupilumab Work
The human body uses chemical messengers called interleukins . ILs allow the different parts of our immune system to communicate and help fight off harmful viruses and bacteria. The immune system of people with inflammatory conditions like atopic eczema overreacts to allergens . This triggers the production of certain ILs, which cause greater inflammation. It is this chronic inflammation that leads to symptoms of eczema such as itchy, dry patches on the skin that are red or darker than a persons normal skin colour, depending on skin tone.
Biologics work by blocking ILs from binding to their cell receptors this stops the immune system from overreacting. Dupilumab works on two specific ILs thought to contribute to atopic conditions: IL-4 and IL-13. By blocking IL-4 and IL-13 from binding to their cell receptors, dupilumab limits the overreaction of the immune system, dampening down the chronic inflammatory response and lessening the symptoms of atopic eczema.
If you think of a chemical messenger such as IL-4 as a key, and a cell receptor as a lock, a biologic drug works in a similar way to fixing a coin over the keyhole so that the key is unable to get into the lock .
Read Also: Can Psoriasis Cause Weight Gain
Dupixent For Other Conditions
You may wonder if Dupixent is used for certain other conditions in addition to those listed above. Here we discuss some conditions that Dupixent may or may not be used to treat.
Dupixent for alopecia
Dupixent is currently in clinical trials to see if its effective in treating alopecia. If you have alopecia, your immune system attacks your hair follicles, causing hair loss. Alopecia ranges from patches of hair loss to total hair loss.
Some people with alopecia taking Dupixent for eczema have had their hair start to regrow while taking the drug.
Dupixent for cancer
Dupixent hasnt been shown to be effective in treating cancer. Other medications used to treat asthma that are similar to Dupixent, such as Xolair, may increase the risk of developing cancer.
Dupixent can help treat nasal polyps in people with chronic rhinosinusitis with nasal polyps. However, these nasal growths are not cancerous.
Dupixent for psoriasis
Dupixent is not approved to treat psoriasis, a condition that causes thick, red patches to appear on the skin. Eczema may appear to be similar to psoriasis. However, eczema is usually much itchier than psoriasis.
Your doctor can determine if you have eczema or psoriasis and if Dupixent is the right treatment for you.
Dupixent for dyshidrotic eczema
What Is The Most Important Information I Should Know About Dupixent
You should not use dupilumab if you are allergic to it.
Dupilumab should not be given to a child younger than 12 years old to treat asthma, or younger than 6 years old to treat eczema.
Tell your doctor if you have ever had:
- eye problems
- a parasite infection or
- if you are scheduled to receive any vaccine.
If you use dupilumab to treat eczema or chronic rhinosinusitis with nasal polyposis, tell your doctor if you also have asthma.
Tell your doctor if you are pregnant or breastfeeding.
If you are pregnant, your name may be listed on a pregnancy registry to track the effects of dupilumab on the baby.
Recommended Reading: Home Uv Light For Psoriasis
What Is A Biologic Drug
Biologic drugs or biologics are genetically engineered from proteins derived from living cells or tissues. Biologics are designed to target specific parts of the immune system that contribute to chronic inflammatory diseases such as atopic dermatitis.
Biologics take an inside out approach to treating inflammatory conditions by addressing the issue at the immune system level, the root cause of many diseases. You can find a more complete explanation here.
What Are The Typical Dosages Of Dupixent
The information below describes dosages that are commonly used or recommended. But be sure to take the dosage your doctor prescribes for you. Your doctor will determine the best dosage to fit your needs.
For eczema and asthma, your starting dose of Dupixent will be higher than your maintenance dose. This higher starting dose is called a loading dose. You will usually receive a loading dose to help the drug reach a steady level in your body more quickly.
After the loading dose, the drug is given every other week as a maintenance dose. There is no weekly dosage option for Dupixent.
The table below lists the recommended dosages for the conditions Dupixent is used to treat.
| Condition |
| 300 mg every other week |
* One kg equals about 2.2 pounds.
Dosage for asthma
For moderate to severe asthma, Dupixent can be used in adults and children ages 12 years and older. For details on the dosages for this condition, see the dosage chart above.
Asthma and eczema are both inflammatory conditions that have a strong connection. If you have both eczema and asthma, your doctor may start you on a higher dose of Dupixent. You may also have a higher dose if youre taking oral corticosteroids to manage your asthma symptoms.
If you need a higher dose due to either of these factors, youll start with a loading dose of 600 mg . After that, your dosage will be 300 mg every other week.
Dosage for eczema
Dupixent is used to treat moderate to severe eczema. To learn more, see the dosage chart above.
Read Also: What Can You Do For Scalp Psoriasis
De Novo Psoriasis In Atopic Dermatitis Patients Treated With Dupilumab
- Journal of the European Academy of Dermatology and Venereology: JEADV
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Is Dupixent Used To Treat Cancer Dyshidrotic Eczema Alopecia Or Psoriasis
No, Dupixent is only approved to treat atopic dermatitis , asthma, and chronic sinusitis with nasal polyps. To learn about these conditions, see the What is Dupixent used for? section above.
But its possible that healthcare professionals may prescribe this drug off-label for other conditions.
If you have questions about Dupixents effectiveness for other conditions, talk with your doctor.
Recommended Reading: What Is The Best Over The Counter Medicine For Psoriasis
Clinical Efficacy And Quality Of Life
A variety of scoring systems that include subjective as well as objective measurements are used to assess the severity of atopic dermatitis, its impact on quality of life, and response to treatment. Some of the most common scoring systems used by health-care professionals in the clinical assessment of AD patients are listed in Table 1.
Table 1::
| Scoring systems |
|---|
| 39 |
FDA: Food and drug administration
Halling et al. in a systematic review and meta-analysis of 22 observational studies on the efficacy and safety of dupilumab in AD, reported that the pooled proportion of patients achieving EASI-50, EASI-75, and EASI-90 after 16 weeks of treatment was 85.1%, 59.8%, and 26.8%, respectively.
Acrodermatitis Continua Of Hallopeau
This type of pustular psoriasis is rare. It causes pus-filled bumps on the fingertips, toes, or both. The disease can also develop underneath the nails.
Often beginning on one finger or toe, new pus-filled bumps may continue to appear. When this happens, new pustules can develop on more than the fingers and toes. In rare cases, the pus-filled bumps can slowly spread up the arms or legs.
Anyone who has pus-filled bumps over much of the skin needs immediate medical care. When widespread, pustular psoriasis can be life-threatening.
The first choice for treating this type of pustular psoriasis often includes the following.
-
Synthetic vitamin D combined with a strong corticosteroid: This combination is applied to the skin.
-
PUVA: This is a type of light treatment that involves taking a medication called psoralen before getting UVA light treatments on the affected skin.
While the above describes what treatment may be used for each type of pustular psoriasis, your treatment plan may include different medications. Your age, other medical conditions , and general health also play key role in determining which treatment is best for you.
ImageGetty Images
ReferencesFitzpatrick JE. Pustular eruptions. In: Fitzpatrick JE and Aeling JL. Dermatology Secrets. Hanley & Belfus, Inc., Philadelphia, 1996:66-7.
Jeon C, Nakamura M, et al. Generalized pustular psoriasis treated with apremilast in a patient with multiple medical comorbidities. JAAD Case Rep. 2017 3: 495-7.
Recommended Reading: Can Psoriasis Go Away And Come Back
Is Dupixent Safe To Use While Pregnant Or Breastfeeding
Before using Dupixent, tell your healthcare provider about all your medical conditions, including if you:
- are pregnant or plan to become pregnant. It is not known whether Dupixent will harm your unborn baby.
- are breastfeeding or plan to breastfeed. It is not known whether Dupixent passes into your breast milk.
New Era Of Psoriasis Treatment
In the 1960s and ’70s, new info about how the immune system — your body’s defense against germs — plays a role in psoriasis led to several new treatments. Drugs like corticosteroids, cyclosporine, and methotrexate became mainstays for managing the disease. For the next few decades, though, advances in treatment slowed down.
Thanks to recent progress in research, that’s history.
Scientists studying other autoimmune diseases found new insights about the immune system. It turns out that some of the problems in those conditions are active in psoriasis, as well.
The new info brought treatments that target specific areas of your immune system. Called biologics, these drugs launched a new era of psoriasis treatment. New biologic therapies work well to treat psoriasis, and other new treatments are close to FDA approval.
Read Also: What Is The Best Probiotic For Psoriasis
Before Starting Dupixent For Eczema
Welcome back to episode #137 of the Healthy Skin Show!
In todays episode, I want to share with you why taking a look at your system before starting a biologic medication like Dupixent is so important.
The reason I say this is because biologic drugs essentially block certain inflammatory pathways that can drive eczema .
But isnt it A GOOD THING to block inflammation?
Yes and no.
Its good to stop symptoms that are driving you nuts especially given that there is an inflammatory component to many skin rash conditions.
But it could also be a bad thing in that youre shutting down a natural alarm system so-to-speak that your body uses to tell you that something is wrong.
Without it working, things can potentially go awry.
Thats why its imperative to fully assess your body and its biochemical systems ahead of time. To illustrate my point, Im going to share a client case to give you some real-life insight.
One point that I want to make here is that this isnt about whether or not you should use Dupixent if its been prescribed by your doctor.
Thats a very personal decision only you can make.
There is a time and place for medication.
Instead, Id like you to understand why it might be better to do a thorough check of your system first to see if some areas are in need of some TLC beforehand.
Dupilumab Treatment In The National Health Service England Setting
The European Medicines Agency granted regulatory approval for dupilumab in September 2017. It was then assessed by the National Institute for Health and Care Excellence , and in August 2018, NICE approved it for regular use on the NHS in England and Wales. Funding for dupilumab is approved for patients with moderate-to-severe atopic eczema whose disease has not responded to at least one other systemic therapy, such as cyclosporine, methotrexate, azathioprine, and mycophenolate mofetil, or when these are contraindicated or not tolerated. Their dermatology life quality index score should also be greater than or equal to 10. In 16 weeks, an adequate response is described as 50% reduction in the EASI and a 4-point reduction in the DLQI. If this is not reached, dupilumab therapy is discontinued.
The recommended dose, given by SC injection, is initially 600 mg , followed by 300 mg given every other week. Patients are trained to self-inject dupilumab.
Also Check: Scalp Psoriasis Cause Hair Loss
How Long Does It Take To Work
Dupixent begins to work after the first injection. However, it may take a few weeks before you notice an improvement in symptoms.
In a clinical study, more than 36% of adults with eczema had relief from itching in 16 weeks or less while taking Dupixent. In children ages 12 to 17 years old, 37% had itching relief in 16 weeks.
You should continue treatment for at least 16 weeks to determine if Dupixent works for you. If your eczema, asthma, or chronic rhinosinusitis with nasal polyps isnt responding or improving after 16 weeks, talk with your doctor. You can discuss whether you should keep taking Dupixent or switch to another treatment.
Here are answers to some frequently asked questions about Dupixent.
Why Its Worth Looking Deeper At Whats Driving Inflammation
To this day, Dupixent has stayed on the shelf of Jessicas fridge.
She was never opposed to using it.
But it was important to her that she didnt miss anything before going that route.
Jessica has shared with me several times on her journey that if shed just taken the Dupixent , she would have never known about any of the other issues hiding under the surface.
Just the one example of her vitamin B12 level which had been steadily dropping
She was glad to get that rectified as B12 deficiency can have very unpleasant symptoms, some of which are permanent like nerve damage in the extremities.
Is she 100% better?
No, theres certainly little issues that pop up here and there for her.
But overall, her quality of life has dramatically improved.
Shes able to enjoy so much more of her life without being controlled by her rashes.
I asked Jessica if she had anything specific that she wanted me to share with you on your journey.
She wants you to know that it is a journey to find what are the root causes of your skin issues. The quick fixes are just a band aid that help with the symptoms. Be patient along the way and realize your healing journey is not going to be linear.
If youre wanting to dive deeper, check out if my virtual clinical practice is a good fit for you!
I hope this episode gives you some much needed insight about what to consider before diving straight into using biologic medications.
Recommended Reading: Cura Para La Psoriasis En El Cuero Cabelludo
Seborrhoeic Dermatitis And Sebopsoriasis Developing In Patients On Dupilumab: Two Case Reports
The Dermatology Centre, Salford Royal NHS Foundation Trust, Manchester NIHR Biomedical Research Centre, Manchester Academic Health Science Centre, Salford, UK
Division of Musculoskeletal and Dermatological Sciences, School of Biological Sciences, Faculty of Biology, Medicine and Health, The University of Manchester, Salford, UK
The Dermatology Centre, Salford Royal NHS Foundation Trust, Manchester NIHR Biomedical Research Centre, Manchester Academic Health Science Centre, Salford, UK
Division of Musculoskeletal and Dermatological Sciences, School of Biological Sciences, Faculty of Biology, Medicine and Health, The University of Manchester, Salford, UK
The Dermatology Centre, Salford Royal NHS Foundation Trust, Manchester NIHR Biomedical Research Centre, Manchester Academic Health Science Centre, Salford, UK
Division of Musculoskeletal and Dermatological Sciences, School of Biological Sciences, Faculty of Biology, Medicine and Health, The University of Manchester, Salford, UK
The Dermatology Centre, Salford Royal NHS Foundation Trust, Manchester NIHR Biomedical Research Centre, Manchester Academic Health Science Centre, Salford, UK
Division of Musculoskeletal and Dermatological Sciences, School of Biological Sciences, Faculty of Biology, Medicine and Health, The University of Manchester, Salford, UK