FDA approves dupilumab for moderate to severe eczema

eczema

“Sanofi and Regeneron Pharmaceuticals, Inc. announced today that the U.S. Food and Drug Administration (FDA) approved Dupixent® (dupilumab) Injection, the first and only biologic medicine approved for the treatment of adults with moderate-to-severe atopic dermatitis (AD) whose disease is not adequately controlled with topical prescription therapies, or when those therapies are not advisable.”

After much anticipation, dupilumab becomes the first biologic approved for the treatment of atopic dermatitis (a form of eczema). Dupilumab is indicated for adults with moderate to severe eczema that are not well controlled with steroid creams or ointments. The current options for these patients are limited. Most often oral immunosuppressants, like prednisone or cyclosporine, are used. These medications may have several adverse effects. Dupilumab is a biologic that aims to more specifically target the underlying factors driving allergic inflammation. In this case it blocks the signals of two molecules, Il-4 and IL-13.

Approval was based on three studies. The results of these studies showed the medication to be effective for the majority of patients. Additionally, 36-38% of patients achieved clear to almost clear skin.

Dupilumab will come in a pre-filled syringe for self-administration, to be given by subcutaneous injection every other week. A loading dose in your physician’s office may be required.

The wholesale cost was reported $37,000 per year. However, the actual cost to patients is still unknown.

Future directions. Two studies are currently testing safety and effectiveness in children, 6 months to 11 years and 12 to 17 years of age. Other uses under investigation include asthma, nasal polyps and eosinophilic esophagitis.

If you do have atopic dermatitis that is not well controlled, speak to your allergy doctor to see if dupilumab is right for you.

To read more about dupilumab, click here. Also, to read about nemolizumab, a new and similar treatment option, click here.

 

Difficult to treat eczema: a review of medications

Sometimes moisturizers and steroid creams aren’t enough. Many patients with severe eczema (atopic dermatitis, AD) require oral medications to keep their skin clear and itching under control. A recent article out of Amsterdam and Germany, reviewed the risks and benefits of several systemic therapies*. Here are the recommendations:

  • Cyclosporin A: first-line short term treatment option for moderate to severe AD. Higher doses (5 mg/kg/day) lead to a more rapid response and higher efficacy.
  • Azathioprine: second-line treatment option.
  • Methotrexate: third-line treatment option for adults.
  • IFN-γ: third-line treatment option.
  • Systemic steroids: not recommended.
  • Intravenous immunoglobulin: not recommended.
  • Montelukast (Singulair): not recommended.
  • Traditional Chinese herbal medicine (TCHM): not recommended.
  • [glossary slug=’mycobacterium-vaccae’ /]: not recommended.
  • Thympopentin-5 (an immunostimulant): not recommended.

What was not included:

What needs to be stated:

  • All of these medications can have significant side effects.
  • It is important to maximize topical treatments, including moisturizers and medications.
  • It is important to identify and minimize exposure to triggers, including foods and contact allergens.

 

* Roekevisch E, Spuls PI, Kuester D, Limpens J. Efficacy and safety of systemic treatments for moderate-to-severe atopic dermatitis: A systematic review. Journal of Allergy and Clinical Immunology 2014; 133(2) 429-438.

Eczema: To Bathe Or Not To Bathe

duckEczema is a common skin problem, affecting 10-20% of children. Dry, scaly patches and intense itching result in unhappy children and parents. Complications include bacterial infections, viral infections, bleeding and most importantly, sleep disturbance. Often allergic eczema (atopic dermatitis, AD) is the precursor to several allergic conditions; food allergy, asthma and allergic rhinitis.

Before getting wet let’s look at the causes of eczema. Genetic mutations and environmental factors combine to produce a skin-barrier defect. This ‘leaky’ skin barrier allows for excessive water loss. Additionally, local immune dysfunction, allergy and infection produce inflammation of the skin. Inflammation leads  to itching. Itching leads to scratching. Scratching leads to further inflammation. Treatment must restore health to the skin and break the itch-scratch-cycle.

There are a staggering number of treatment choices; oils, lotions, creams, soaps and ointments. Some are natural and some contain potent steroids. An effective treatment regimen should include a combination of medicines, specific for the individual patient. Rehydrating the skin is essential for healing the skin and preventing recurrence. Doctors advise frequent moisturizer use and bathing on a regular schedule.  Recommendations range from bathing twice daily to twice weekly. The frequency is likely based on physician training and experience.  There is little consensus and even less evidence which is best.

It is commonly accepted that bathing dries out the skin. Water not only washes away dirt but also natural oils. Use of soap and harsh detergents, such as sodium lauryl sufate (SLS), has been shown to remove protective skin lipids and natural moisturizing factors. Bar soaps are often highly alkaline and can result in further drying. They may have chemical additives (i.e. perfumes) that can act as irritants or allergens causing inflammation. Hot and very hot water contribute to inflammation as well. The problems don’t end when the bath is over. Aggressive drying creates friction and skin damage.

On the other hand, bathing has important benefits. Soaking in water may help to rehydrate skin cells. Cleaning bacteria from the skin reduces the risk of infection. The intermittent addition of bleach is effective in lowering the amount of bacteria living on the skin.

My conclusion, bathing can dry out the skin UNLESS done properly. Here are some tips for effective bathing and hydration:

• Keep water at a lukewarm temperature.

• The bath should last approximately 15-20 minutes.

• Avoid harsh soaps, bubble bath and hand washes. Instead use emollient washing products.

• Be gentle. Try not to rub your body too strongly with your towel.

• Apply moisturizer to slightly damp skin within three minutes of getting out.

• Intermittent use of antiseptic bath oils and dilute bleach can reduce flares.

• Other additives may be helpful, for example magnesium salts and natural colloidal oatmeal.

• Use LOTS of moisturizer following the bath and throughout the day. Emollients (moisturizers) and steroids should be applied in a 10:1 ratio.

Application should be separated by 30 minutes, 1 hour for tacrolimus. Remember not to insert hands or fingers directly into emollients, in order to avoid microbial contamination of the contents.