Protopic and Elidel

Ideally, we would find the cause or trigger of the eczema, simply avoid it and thus not need any medications at all. That is the dream!

 

It is, however, extremely rare in my experience, especially for the patients that make it to the Chicago Integrative Eczema Center. By this time, many have tried avoiding foods, animals, dust mites, stressful situations, and other potential triggers, but continue to have flares. Some families even stop breastfeeding the baby to see if an "elemental" formula can help. (This is something I generally frown upon since there are so many important benefits of breast milk, and it so often does not seem to make a significant difference in the eczema, sadly).

 

The next step is to use things like moisturizers and natural products like essential oils and butters, to protect and nourish the skin.  This we try to always do since we firmly believe that the skin barrier is damaged in all eczema patients. For the milder types of eczema, this alone can be enough and that is also a reason to celebrate.

 

Supplements like Vitamin D and probiotics may also be added, and gentle treatments such as bath oils or specialized clothing or garments may be recommended, such as medical grade silk, or Unna wraps. Sometimes here we will consider Traditional Chinese Medicine, acupuncture, or hypnosis as well.

 

If all of these are not enough, or if the eczema is severe enough to suggest that they will not likely be enough, we often consider using topical steroids. Our goal is to use them very briefly to calm the skin down, allow it to heal, and to break the itch-scratch cycle. Because we are concerned with corticosteroid addiction/dependence and side effects, our goal is to use them for just a few days up to a week or two at most, then to rest the skin completely for roughly the same length of time that the steroids were used. When this works properly, most patients find that just a short burst can calm the flare, allow the skin to heal again, and then go many days or even weeks before needing them again. Ideally, this period grows longer and longer to the point that we celebrate one year anniversaries of "no steroids" for many patients!  Usually at that point, they "graduate" from our care.

 

But what about those for whom the topical steroids are just not enough? Or, more commonly, those that cannot rest for more than a day or two from the topical steroids before flaring up again? Of course, we want to make sure that everything else is happening or has happened already: avoiding triggers and allergens, moisturizing and nourishing the skin well, bathing properly, eating a proper diet, ensuring that the skin is not infected, etc. If despite these, the eczema is still not under control, that is when we talk about Protopic and Elidel.

 

Tacrolimus was discovered in 1984 and is produced by a type of natural soil bacterium, Streptomyces tsukubaensis. Pimecrolimus is a closely-related compound and has a nearly-identical mechanism of action. We will discuss them as essentially being equal for our purposes here.

 

They both work to calm the immune system and are much more specific than steroids. Because they are so much more specific, they lack almost all of the worrisome effects of steroids: they do not cause thinning of the skin, stretch marks, or increased hair growth. As we know, if enough steroids are applied to the skin, they can be absorbed, and the same is true for these medications, though it takes a fairly impressive amount to be of concern. That said, Protopic and Elidel also lack most of the scary effects of steroids systemically: they do not cause weight gain, poor growth, or adrenal suppression.

 

All of these explain why when these medications came on the market over a decade ago, there was tremendous interest in them. Safer, gentler, and effective--although probably not quite as powerful as some of the stronger topical cortisones on the market. In fact, they were being prescribed at a tremendous pace, often off-label as a "first line" treatment, even though they are approved as "second-line" treatments--when topical steroids have failed or are at risk of causing significant side effects.  Some feel that because of this much more aggressive marketing and prescribing than was anticipated, that in 2005 the FDA issued a "black box warning"--similar to the one on cigarette packages--that states:

 

"The safety of using Protopic, and drugs like it, for a long period of time is not known. A very small number of people who have used Protopic have had cancer (for example, skin or lymphoma). However, a link with Protopic has not been shown. Patients should avoid using Protopic continuously for a long time and apply Protopic only to areas with eczema. If the eczema does not improve within 6 weeks, patients should talk to their doctor."

 

This caused something of a panic among patients and physicians, and still does to this day. The truth is that there is no effective treatment known that does not have potential side effects--even water, gift of life, kills more children than almost any other cause (Drowning is the second-leading cause of unintentional injury deaths in children aged 1-14 years).

 

The studies since then have been very reassuring and despite an extensive body of evidence, no causal relationship has been demonstrated between the use of these medications topically and an increased risk of lymphoma. In fact, there are a number of reports that suggest the lymphoma incidence in the patients using these medications is significantly less than is seen in the general US population, for reasons that are not entirely clear.

 

That being said, we use these treatments only when we absolutely must. When we do so, we use them with respect and careful monitoring, and try to use them for the briefest period of time necessary, generally just long enough to keep the skin calm so it can heal or to give a break from topical steroids to avoid side effects and dependence. Fortunately, these medications remain on the market and continue to appear to be actually safe, despite the theoretical risks. In the meantime, we continue to search for better and safer treatments for eczema, and continue to hope for a cure.