2 FDA-approved medications increase treatment options for eczema

Adults living with severe atopic dermatitis now have a treatment that’s FDA approved for them.

February 2018 – Due to research breakthroughs, scientists know more about atopic dermatitis (AD), the most common type of eczema, than ever before. These breakthroughs are leading to new treatments.

The U.S. Food and Drug Administration (FDA) has approved two medications, and more than 40 possible treatments for AD are being studied.

For patients with AD, the newer treatment options are:

A steroid-free, prescription ointment

Purpose: Reduce skin’s redness and swelling

FDA approved to treat: Patients 2 years of age and older who have AD

Known by the generic name of crisaborole (kris-a-bor-ole), findings from studies show that this ointment can reduce redness and swelling in the skin. It’s thought that crisaborole may also prevent new redness and swelling from developing.

In two clinical trials, about 50% of patients had clear or nearly clear skin after applying the medicated ointment for 4 weeks. During these 4-week studies, patients were to apply crisaborole twice a day.

During this type of study, some patients in the study receive a treatment that looks just like the medication but does not contain medication. The treatment that doesn’t contain medication is called a placebo. Giving some patients the placebo helps researchers know how well the medication works.

In these clinical trials, the patients who receive the placebo also had good results. Between 40% and 30% had clear or nearly clear skin at the end of 4 weeks. This may have happened because they were applying an ointment to their skin twice a day. Applying moisturizer can help clear AD.

These clinical trials included patients of diverse ages, which ranged from 2 to 79 years of age. Most patients (more than 85%) were under 18 years of age.

During these trials, researchers found that crisaborole also helped reduce the itch and rash, along with the weeping, thickening, and hardening of the skin.

As for safety, side effects seem few. In the 4-week trials, the most common side effect was burning and stinging where crisaborole was applied.

We have yet to learn the long-term safety of this medication. The longest study we have ran 48 weeks. During that study, the side effects most often reported were pain where the medication was applied and infection on the treated skin. It’s important to remember that skin infections are common in people who have AD.

Researchers believe this medication can be safely used long-term, but more studies are needed before we know for sure.

An injection that calms the immune system

Purpose: Calm the immune system in order to clear the skin

FDA approved to treat: Adults who have moderate-to-severe AD

The generic name for this medication is dupilumab (do-pill-you-mab). It’s considered a breakthrough treatment for adults who have moderate or severe AD.

In clinical trials, about 1/3 of the patients who received this medication saw their AD clear (or nearly clear) at the end of 16 weeks. Many more patients had significantly fewer itchy patches of AD, less itch, and reduced swelling and redness.

Having significantly less AD also improved patients’ outlook on life. Many patients with severe AD suffer from depression and anxiety. Some consider suicide. In these studies, as their skin cleared, these feelings diminished.

The most common side effect seen in these studies was a skin reaction where the shot is given.

Other common side effects seen in these clinical trials include cold sores, pink eye, and an eye disease known as keratitis (ker-ah-tie-tis). Caught early, all of these conditions can be successfully treated.

Dupiliumab is a type of medication called a biologic. It works by suppressing part of the immune system. The FDA has approved several biologics to treat psoriasis, another common skin disease.

We still don’t know whether dupilumab can be safely taken long term, such as for the rest of your life.

If this is an option for you, you’ll learn how to give yourself an injection.

Ask your dermatologist about your treatment options

No one treatment is the right choice for everyone. Your dermatologist can tell you whether one of these newer treatments may be an option for you.

Image used with permission of the American Academy of Dermatology National Library of Dermatologic Teaching Slides.

Eichenfield LF, Call RS, et al. “Long-term safety of crisaborole ointment 2% in children and adults with mild to moderate atopic dermatitis.” J Am Acad Dermatol 2017; 77:641-9.

Fleming P and Drucker AM. “Risk of infection in patients with atopic dermatitis treated with dupilumab: A meta-analysis of randomized controlled trials.” J Am Acad Dermatol 2018; 78:62-9.

Houghton V. “Playing the angles: New treatments target potential pathways for atopic dermatitis.” Dermatol World. 2016; 26(12):22-9.

Hoy SM. “Crisaborole ointment 2%: A review in mild to moderate atopic dermatitis.” Am J Clin Dermatol. 2017; 18(6):837-43.

Simpson EL, Gadkari A, et al. “Dupilumab therapy provides clinically meaningful improvement in patient-reported outcomes (PROs): A phase IIb, randomized, placebo-controlled, clinical trial in adult patients with moderate-to-severe atopic dermatitis (AD).” J Am Acad Dermatol 2016; 75:506-15.

Simpson EL, Bieber T, et al. “Patient burden of moderate-to-severe atopic dermatitis (AD): Insights from a phase 2b clinical trial of dupilumab in adults.” J Am Acad Dermatol. 2016; 74:491-8.

U.S. Food and Drug Administration. “FDA approves new eczema drug Dupixent.” News releases issued March 28, 2017. Last accessed March 9, 2018.