Meningitis Vaccine Recommendations

Delgocitinib Cream Under Review For Chronic Hand Eczema

The Food and Drug Administration (FDA) has accepted for filing the New Drug Application (NDA) for delgocitinib cream as a treatment for moderate to severe chronic hand eczema in adults who have had an inadequate response to, or for whom topical corticosteroids are not advisable.

Delgocitinib is a topical pan-Janus kinase (JAK) inhibitor that blocks the activation of the JAK-STAT pathway, which has been shown to play a key role in the pathophysiology of chronic inflammatory skin diseases. The NDA is supported by data from the phase 3 DELTA 1 (ClinicalTrials.Gov Identifier: NCT04871711) and DELTA 2 (ClinicalTrials.Gov Identifier: NCT04872101) studies. 

The primary endpoint in both trials was the Investigator's Global Assessment for chronic hand eczema (CHE) treatment success at week 16, defined as a score of 0 (clear) or 1 (almost clear, with little or no disease left) with at least a 2-step improvement from baseline. 

Findings showed a significantly larger proportion of delgocitinib-treated patients achieved treatment success compared with those who received vehicle. Delgocitinib also significantly reduced the itch and pain associated with CHE (secondary endpoints).

The FDA is expected to make a decision on approval in the second half of 2025.

This article originally appeared on MPR

References:

FDA accepts LEO Pharma's filing of delgocitinib cream New Drug Application for the treatment of chronic hand eczema. News release. Leo Pharma. September 23, 2024. Https://www.Businesswire.Com/news/home/20240923600460/en/FDA-Accepts-LEO-Pharma%E2%80%99s-Filing-of-Delgocitinib-Cream-New-Drug-Application-for-the-Treatment-of-Chronic-Hand-Eczema.

Is Eczema An Autoimmune Disease Or Something Else?

Eczema is a group of related conditions causing itchy, dry, inflamed skin that can appear red, purple, ashen, or dark brown, depending on skin tone. While eczema does involve the immune system, most scientists wouldn't classify eczema as an autoimmune disease.

Autoimmune diseases occur when the body's immune system attacks a specific part of the body in a targeted way, leading to inflammation, pain, or other symptoms. Atopic dermatitis (one type of eczema), in particular, may exist on a spectrum with autoimmune disease, and having it may increase your risk of autoimmune conditions.

Evgeniia Gordeeva / Getty Images

Understanding Eczema Types The group of skin conditions, sometimes called eczema, have some broadly similar symptoms and share some of the same causes. Some of the most prevalent types of eczema include: Atopic dermatitis is the most common disease that causes chronic symptoms of dry, itchy, and discolored skin due to inflammation. It is also the most well-studied type of eczema. Contact dermatitis (allergic contact dermatitis) can be brought on by environmental triggers (e.G., poison ivy, latex, nickel), but symptoms are often temporary. Dyshidrotic dermatitis (dyshidrotic eczema) causes dry skin, burning sensations, and blisters. Neurodermatitis (lichen simplex chronicus) causes itchy skin that can become thickened and discolored over time. Nummular eczema (discoid eczema) creates small, rounded, itchy regions, especially on the arms and legs. Seborrheic dermatitis causes dry, flaky skin on the scalp. Stasis dermatitis is caused by poor circulation in the legs, leading to symptoms like skin discoloration and itchy, swollen legs. Causes The underlying causes of eczema are complex and not completely understood. However, researchers believe that the following contribute to eczema: Genetic variations Inflammation Overreaction to external factors Experts believe that eczema occurs, in part, from exaggerated responses to environmental factors and often group it with allergic conditions. Triggers Some important eczema triggers are: Allergens in the environment (e.G., pet dander, dust mites) Irritants from perfumes or soaps in personal care products Stressful experiences Winter weather, with low humidity and low temperatures Some people also notice their symptoms worsen when they eat specific foods, but this connection isn't well established.  Symptoms Eczema caused by atopic dermatitis causes: Dry, itchy skin Color changes in skin, such as red, purple, ashen, or dark brown, depending on skin tone, and sometimes scaliness Additionally, age can affect how eczema presents. Symptoms appear on the face, trunk, arms, and legs within the first year of life. Later in life, they arise in skinfolds, like the inside of elbows. Sometimes, these areas become so itchy and scaly that they peel away, leading to bleeding. People with eczema usually have periods in which their symptoms flare up and worsen and other times when they are less severe.  Autoimmune Diseases Explained When your immune system is healthy, it helps protect you against invasions from dangerous microorganisms like viruses and bacteria. It does this through complex and coordinated communications and responses in your immune system. Autoimmune diseases occur when part of the immune system mistakenly identifies part of your body as a threat, triggering an inappropriate immune response and targeting this part of your body. The area of the body attacked by the immune system will become painful and inflamed, and other symptoms, such as fatigue, recurring fever, and muscle aches, can occur. Researchers are still trying to solve the problem of the immune system becoming inappropriately targeted towards part of your body. Researchers are still trying to understand the causes of autoimmune diseases. They do know that it's a complex interaction of genetic and environmental factors that coincide to cause an inappropriate immune reaction. In many cases, autoimmune diseases also may involve the development of antibodies against part of your body. These are different from the normal antibodies you might develop to fight an infection or help prevent you from getting sick after you've had a vaccine. Is Eczema an Autoimmune Disease? Autoimmune disease and eczema both involve abnormal and heightened immune responses that can lead to inflammation and other symptoms. However, most scientists would not classify eczema as an autoimmune disease. Healthcare providers have historically classified eczema as part of the "atopic march," a specific progression of allergies that begins with begins with skin symptoms, then moves to gastrointestinal symptoms, and eventually causes respiratory symptoms. The immune system does play a vital role in eczema, though. Like in many autoimmune diseases, a certain kind of immune cell called T cells can become overactive, releasing large amounts of immune-signaling molecules that should not be released. This release causes additional changes that lead to painful, itchy skin. Knowledge about this topic is evolving. Some scientists think it may be more appropriate to think of atopic dermatitis as a spectrum with autoimmune disorders. This is because atopic allergies can be seen as stepping stones to autoimmunity. If you have eczema (atopic dermatitis), you have a slightly increased risk of being diagnosed with an autoimmune condition. With severe eczema, your risk is about twice as high for an autoimmune disease as that of someone who doesn't have eczema. (Potential risks in other types of eczema aren't as well studied.) This risk seems to be increased for certain autoimmune diseases but not others. Some autoimmune diseases you might be more susceptible to include rheumatoid arthritis, inflammatory bowel disease, psoriatic arthritis, Sjögren's syndrome, and autoimmune thyroiditis. Can Eczema Be a Symptom of Autoimmune Diseases? Usually, a healthcare provider wouldn't consider eczema a potential autoimmune disease symptom. However, it's possible to have both eczema and an autoimmune disease, but they're typically thought of as comorbid conditions—two different diseases occurring in the same person. Certain autoimmune conditions, like Sjögren's disease, may also cause skin symptoms similar to those found in eczema, like dry skin, as well as additional symptoms that are not found in eczema. How to Treat and Manage Eczema Topical Treatments The cornerstone of treatment is using quality moisturizers (fragrance-free with high oil content) daily, even if you are not experiencing a flare-up. Ideally, you should do this right after you shower to help trap moisture.  Topical corticosteroids (those applied to your skin) are typically the first approach during a symptom flare-up. Depending on the severity of your flare-up, you might need to use a more potent dose of steroid for a more prolonged period. Examples of prescription topical treatments include: Protopic (tacrolimus) or Elidel (pimecrolimus) are similar medications applied directly to the skin. Eucrisa (crisaborole) is a newer medication applied to the skin to help decrease the amount of steroid cream you need. Opzelura (ruxolitinib) is a topical medication intended for short-term use. Systemic Medications and In-Office Treatment A healthcare provider may prescribe systemic medications for eczema, which work throughout the body, such as: Dupixent (dupilumab) or Adbry (tralokinumab): These are newer, injectable biologic medications that can help improve symptoms. Rinvoq (upadacitinib) or Cibinqo (abrocitinib): These Janus-kinase (JAK) inhibitors are relatively new oral medications used for treatment-resistant disease if biologics have not worked or are not available. Sandimmune (cyclosporine), Imuran (azathioprine), or Trexall (methotrexate): These are older and less expensive oral medications that suppress the immune system if other treatments have not helped or are not available. A healthcare provider may recommend in-office treatment with phototherapy (light therapy) if other treatments have not helped relieve your symptoms. Alternative Options Most of these are not well-researched in terms of scientific studies, but some people find complementary approaches helpful. Some of these are: Applying natural oils to the affected areas, such as sunflower seed oil or coconut oil Using immunotherapy with an allergist, such as those used for food allergies or seasonal allergies Using certain oral supplements, like vitamin D, evening primrose oil, or probiotics Taking steps to reduce your stress, e.G., through massages, hobbies, meditation, and/or exercise Additional Considerations If you have co-occurring eczema and an autoimmune disease, ensure your healthcare team coordinates your treatment and has an up-to-date list of your medications. Some medications for autoimmune diseases work by suppressing certain parts of the immune system, so they may help with your eczema but, conversely, could also worsen it. When to Contact a Healthcare Provider  Sometimes, bleeding skin from moderate to severe eczema can lead to infection. If you notice unusual symptoms like fever, puffy skin, or rash, contact a healthcare provider immediately, as you might need antibiotic treatment.  You should also contact a healthcare provider if you are having a flare and your standard control methods are not helping. You might need to change or escalate treatment. If your eczema interferes with your quality of life, talk to your healthcare provider about your options. Summary Eczema is a group of medical conditions causing itchy, inflamed skin. The term "eczema" is often used to refer to atopic dermatitis. Atopic dermatitis is caused by specific dysregulations and overactive responses in your immune system. There is a lot of overlap between the immune dysregulations found in eczema and those found in autoimmune conditions. However, most scientists do not classify eczema as an autoimmune disease because the immune system response isn't as targeted as it is in true autoimmune conditions. However, having eczema, at least atopic dermatitis, slightly increases the risk of autoimmune disease in the future. 

'I've Had Severe Eczema All My Life And I Thought It Was Going To Kill Me'

Countless people can relate to the profound impact that eczema has on daily life.

The relentless discomfort of parched, itchy and inflamed skin can significantly diminish people's quality of life, leading to issues like exhaustion and low self-esteem. However, for some, this chronic dermatological issue poses a more sinister threat, with potentially fatal complications that demand immediate medical attention.

Freya McGreevy from Chorlton, in Greater Manchester, is all too familiar with the severe consequences of eczema, having suffered from the condition since childhood. Initially, her family suspected allergies might be the culprit behind her aggravated skin, but testing ruled this out.

Freya has enflamed skin all over her face (

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Freya McGreevy) Freya's eczema can cause open wounds (

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Freya McGreevy)

Freya's battle with eczema intensified to such an extent that she had to miss school due to the severity of her symptoms, which included open sores, oozing skin, and rashes that made even wearing clothes an excruciating ordeal. "They couldn't find any pattern for my eczema," the 27-year-old told the Manchester Evening News.

"So, we just had to be prepared for if a flare-up occurred, which can go from clear skin to open wounds, wet eczema and rashes within hours." It was only at the age of 26 that Freya, who works at Afflecks Palace, discovered her painful skin woes stemmed from an overactive immune system.

The only way she found any relief was through a steroid cream prescribed by doctors. While the treatment is used by many with the condition, it can lead to side effects including thinned skin, skin that bruises more easily and loss of pigment. "It's a big catch 22 for many eczema warriors," Freya added. "But the steroid cream doctors would prescribe is the only thing to calm down the eczema. Over the years I was prescribed strong and stronger steroid creams until none of them worked.

"It also meant I was getting skin infections constantly and I was on antibiotics the whole time I was 17." Freya tried countless skin products in a bid to find an alternative to steroid cream, from skin ointments to oat baths, but nothing helped ease her suffering.

Freya McGreevy when her condition was more under control (

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Freya McGreevy)

"I started on hydrocortisone and over the years have been given Fucibet, Dermovate, Betnovate, Eumovate, Protopic, as well as trying herbal remedies, Aveeno, Child's Farm, Epiderm, E45, oat baths, wet wrap bandages and solution for my scalp eczema," she added.

"I have always been in and out of A&E for flare ups, because when eczema is as severe as mine, the whole body becomes inflamed and it's hard to walk, turn my head, wear clothes and function properly." Eczema is the name for a group of inflammatory skin conditions that cause itchiness, dry skin, rashes, scaly patches, blisters and skin infections. It can begin during childhood, adolescence, or adulthood and can range from mild to severe.

Severe eczema, like Freya's, may include periods of flare-ups that can last many days or even several weeks. Severe eczema isn't just about itchy skin and rashes; it can lead to hospital stays if not treated properly. Those battling severe eczema are also more likely to develop food allergies and asthma, a trio of conditions often seen together known as the Atopic March.

Freya's struggle with eczema peaked at 25, calling it "the worst it's ever been". She suffered through a year-long severe flare-up that forced her to take a three-month break from work. Even after taking oral steroids, her condition worsened to the point of hospitalisation due to sepsis.

The condition can cause huge blisters (

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Freya McGreevy)

"The nurses couldn't treat the eczema because there was no dermatologist in the hospital and they were not trained to deal with extreme cases," she explained. It was only after developing sepsis that Freya was referred to a dermatologist.

She expressed her frustration, saying, "I feel my body and me can never reach my full potential because of flare-up fears." When traditional creams failed, Freya was put on immunosuppressants and UV therapy, but to no avail. She resorted back to oral steroids, antibiotics, and methotrexate injections, which are typically used for inflammatory diseases.

Freya has been on these treatments for the past 18 months and while they seem to help, she is concerned about potential long-term side effects. "They make you incredibly angry, gain weight and sweat a lot," she said.

"It's not fun. I also have to take folic acid with this and for half the week I am nauseous, hormonal and have no appetite. This treatment is causing me liver damage because it lowers my immunity and organ functionality, however, I am on the waiting list for biologics, a treatment which targets specific parts of the immune system to reduce inflammation and improve symptoms.

"These are injections I will have to take for the rest of my life in order to suppress the area of my immune system which causes the eczema. I almost feel like I have had to wait for it to get to a life-threatening/debilitating level in order to get the correct treatment because there isn't enough knowledge or resources on severe eczema.

"The only thing that helps my eczema now is big strong medications and love from friends and family. I still moisturise, take oat baths and wear protective cotton layers under clothes to keep my eczema at bay, all on top of the methotrexate injections, but it will always be there."

Despite the constant physical pain she endures, Freya says the worst part about her condition is the mental aspect. "The worst thing is the mental side of this condition," she added.

"I feel so ungrateful saying this because people mean well, but having people ask all my life, 'What's that on your face? ' 'Oh, that looks sore,' 'Have you tried this? It worked when I was a baby,' it just makes me feel more alienated."

"I was bedbound for the majority 2023 and had to use a wheelchair in order for me to continue earning money. No one apart from close family and my partner could comprehend that it was eczema causing it." Freya has opened up about her battle with severe eczema, revealing she often feels guilty for having to visit A&E but sees it as her only choice.

"When even your clothing is a threat of infection, it's the only option," she explained. "I never picture myself with eczema so it's always a horrible shock when I catch some spots or scabs when I'm going about my day. Sometimes I can't wear clothes to cover it up, so the only option is to see it.

"He steps up into carer mode when he recognises my skin getting worse. He will literally help me in and out of bed and baths when it's bad, moisturise my whole body and go and get late night bandages if we run out.

"And he is still attracted to me which I struggle with because I am so disgusted by my own skin. If it wasn't for him, I fear that the mental health issues that came with my eczema when it was at it's absolutely worst would have been the thing that killed me."

Now that her condition is more manageable, Freya expresses immense gratitude: "Now my skin is more controlled, I am just so grateful to do normal things like going on holiday, taking part in sport and being able to walk to work."

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