Is COVID-19 an Indication to Temporarily Modify Dermatological Management Plans?

By COVID-19 Resources, Medical Dermatology, Patient Care
Coronavirus image

Source: Journal of Drugs in Dermatology

While the world lives under the shadow of the novel coronavirus (COVID-19) pandemic, dermatologists wonder if the current situation calls for a temporary change in the management of skin conditions.

Immunosuppressive drugs are used ubiquitously in the modern treatment of inflammatory and autoimmune skin diseases like psoriasis, bullous diseases, connective tissue diseases, and many others. Treatment of these conditions is based on the suppression of the patient’s immune system using steroids, steroid-sparing drugs, and biological agents.1

While the effects of the novel coronavirus on the body and its immune system are still being studied, there is overwhelming evidence that the virus could directly or indirectly affect the immune system. In one study, lymphocytopenia was reported in 83.2% of the admitted patients and might be associated with a worse prognosis.2In another study, a steady decline in the lymphocyte counts was recorded in a group of patients who did not survive the infection.3

While the coexisting comorbid medical conditions (such as diabetes or heart disease) are considered as independent predictors of an adverse outcome of the novel coronavirus infection,4 it could be assumed that the chronic inflammatory and autoimmune skin diseases like psoriasis by themselves might imply an additional risk factor of developing more serious symptoms of the novel virus due to their chronicity and effects on the immune system.5

The use of immunosuppressive to treat these conditions can amplify this effect, and it might leave the patient vulnerable to more serious complications should an infection with the novel coronavirus be established. Hence, it may be wise to restrict temporarily the use of immunosuppressive agents including systemic steroids, steroid-sparing agents, and biologics in dermatology daily practice until more evidence is available about their safety in the current pandemic.6As a relates point, the International Psoriasis Council declared an urgent statement on March 11, 2020 that the physician should be alert to the potentially harmful effects of COVID-19 infection on patients with psoriasis and to immediately discontinue or postpone immunosuppressant medications for psoriasis patients diagnosed with COVID-19 disease.7

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What’s New for Itch

By Medical Dermatology, ODAC Sessions
ODAC Dermatology Conference Dr. Berman Image

Source: Next Steps in Dermatology

Dermatologists are well aware of the difficulty in managing itchy patients. Itch can be caused by a number of cutaneous and extracutaneous diseases. Regardless of the etiology, itch is one of the most frustrating symptoms of patients and management dilemmas for dermatologists. At the 16th Annual ODAC conference, Dr. Brian Berman reviewed some of the emerging therapies for the treatment of itch and the etiologies for which they are currently under investigation.

Nemolizumab is a monoclonal antibody directed at the IL-31 receptor A. It is currently being studied for use in atopic dermatitis. Recent phase II data have shown improvement for itch in atopic dermatitis over 64 weeks1. A few of the less common side effects that were seen in this study included peripheral edema and elevations in blood CPK levels.

Tapinarof cream is a first-in-class, naturally derived, non-steroidal topical agent. It is currently being investigated for use in psoriasis and atopic dermatitis. Tapinarof is a therapeutic aryl hydrocarbon modulating agent (or TAMA) and inhibits specific proinflammatory mediators, including IL-6 and IL-17A2.  One of the more interesting targets of tapinarof is nuclear factor-erythroid 2-related factor-2 (Nrf2), which happens to be one of the mechanisms through which coal tar produces its beneficial effects.

Hypochlorous acid gel is being used for its anti-inflammatory properties. This topical has potential utility for atopic and seborrheic dermatitis-related itch.

Serlopitant is an oral NK1 receptor antagonist. It is currently being investigated for use in chronic pruritus, pruritus in psoriasis, and prurigo nodularis. Substance P binds to the NK1 receptor peripherally, in the ganglion and brain to cause/increase the perception of itch, and as such, NK1 receptor antagonists are an up and coming mechanistic target for itch. Phase II data appear to be promising3.

Remetinostat (previously referred to as SHAPE), a topical histone deacetylase inhibitor, is currently under investigation for treating pruritus in patients with stage IA-IIA mycosis fungoides4. Preliminary data are promising as the topical route of the medication appears to decrease itch while limiting side effects compared to systemic histone deacetylase inhibitors.

Omalizumab, an anti-IgE monoclonal antibody, is approved for use for chronic idiopathic or chronic spontaneous urticaria5. It is notable that in the pivotal, phase 3 study published in the New England Journal of Medicine, the primary endpoint was itch-severity score rather than urticarial lesion counts. The use of this endpoint highlights the magnitude of itch in urticaria.

Physician assurance reduces itch. In a recent study6, a physician administered a histamine skin prick to 76 participants. After 3 minutes, half of the randomly selected participants were assured by the physician in the following way. “From this point forward your allergic reaction will start to diminish, and your rash and irritation will go away.” In the assured group, it was found that over the next 15 minutes, itchiness of the area declined significantly faster than the group not assured by the physician.


Hyperhydrosis: Where are we?

By Medical Dermatology, ODAC Sessions
Hydrosis Chart

Source: Next Steps in Derm

Can you think of a skin condition that has a greater negative impact on quality of life than eczema or psoriasis?  That’s right, you guess it—hyperhidrosis!  I still remember my first hyperhidrosis patient who refused to shake people’s hands, go on dates, or attend social events due to his condition.  After his treatment, he was like a new man.  I can’t tell you how satisfying it was to see his life changed after treatment. That’s why I’m so excited to share what I learned from Dr. Adam Friedman at ODAC 2019 regarding hyperhidrosis.   Dr. Adam Friedman is Professor and Interim Chair of Dermatology, Residency Program Director, Director of Translational Research, and Director of the Supportive Oncodermatology Clinic in the Department of Dermatology at The George Washington University School of Medicine & Health Sciences.

Did You Know?

Nearly 5% of the world’s population suffers from hyperhidrosis—that’s 365 million people worldwide! In the U.S., 7.8 to 13.4 million people (2.8-4.8%) are estimated to be affected by hyperhidrosis—that’s comparable to the prevalence of psoriasis.  Spalding et al. showed that patients with hyperhidrosis reported a worse quality of life compared to those with atopic dermatitis or psoriasis (Value in Health 2003).  That made me raise my eyebrows for sure!

Hyperhidrosis stats
Spalding et al. Value in Health 2003;6(3):242(abstract)


Know Your Sweaters: First, Diagnose

Hyperhidrosis can be divided into primary (usually focal) and secondary (generalized).  For secondary hyperhidrosis, the underlying cause needs to be addressed, which may include drugs, cardiovascular disorders, respiratory failure, infections, malignancies, and metabolic disorders.  For primary hyperhidrosis, now, that’s where we dermatologists step in and save the day. So, what are our options?

Treatment Options

There are non-invasive, minimally invasive, and surgical options for the treatment of hyperhidrosis.  Here, we will discuss everything but surgical options and energy-based treatment.

  • Topical aluminum chloride, aluminum chloride hexahydrate, or aluminum zirconium trichlorohydrex
    • This is applied on skin overnight (to remain on skin for 6-8 hours, during non-sweating hours) and washed off in the morning before sweating begins
    • A non-medicated deodorant should be applied in the morning after showering
    • Can use topical steroids for skin irritation
    • Cons: itching and burning of skin, time-consuming, can damage fabrics, temporary relief
  • Inotophoresis
    • Need treatment for 20-30 minutes a session, 3-4 times a week. This can be effective (81-91% response), but who has time for that?
    • Cons: cumbersome, can be costly, long-term therapy, and again…time-consuming
  • Topical glycopyrronium tosylate (Qbrexa)—the new kid on the block! And he’s FDA-approved, too. Whoohoo!
    • This can be applied nightly onto clean skin and can be used in conjunction with an over-the-counter antiperspirant
    • Improvement can be expected in 1-3 weeks.
    • Can be used in kids (approved for >9 years of age)
    • Cons: anticholinergic side effects such as dry eyes, dry mouth, blurred vision (need to emphasize the need to wash hands thoroughly after use to minimize risk), long-term therapy, may be costly
  • Systemic anticholinergics: off-label use for hyperhidrosis
    • Glycopyrrolate
      • Can start at 1mg twice daily and increase up to 6mg a day, or until limited by anticholinergic side effects
    • Oxybutynin
      • Can start at 5 to 10mg daily and increase to 15 to 20mg daily
      • A study in kids showed a 90% response rate at 2mg daily.
    • Cons: again, anticholinergic side effects — ones listed above, as well as constipation, urinary retention, bradycardia, etc.
  • Beta-adrenergic blockers
    • This is great for patients with social phobias and performance anxiety!
    • Most can tolerate a dose of 10 to 20mg (to be taken 1 hour before). But don’t forget to check the resting blood pressure and heart rate beforehand!  Oh, and also, they need a “test run” at home, just to make sure all goes smoothly before the actual “showtime”.
    • Contraindications: bradycardia, AV block, asthma
  • Botulinum toxin injection
    • Before treatment: patients should avoid deodorants for 24 hours prior and rest comfortably for 30 minutes prior
    • Treatment: after making an outline of the area, inject at a depth of 2mm, at a 45 degree angle with the bevel up, 1-2cm apart
    • What to expect: onset is about 2-4 days and duration is 3-7 months
    • Other considerations
      • Topical analgesics help a ton!
      • Do not use sterile water—can sting
      • If you buy the toxin and inject, use the CPT code 64650 and J code J0585 (with units)
      • If you prescribe the toxin to a pharmacy, provider bills only for the injection service, and patient pays co-pay for both the toxin and injections
    • Cons: can be painful and expensive

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Hot Topics in Infectious Disease

By Medical Dermatology, ODAC Sessions
Justin Finch MD Presenting at ODAC Dermatology Conference

Source: Dermatology News

New tricks from ticks, near-zero Zika, and the perils of personal grooming: Dermatologists have a lot to think about along the infectious disease spectrum in 2019, according to Justin Finch, MD, speaking at the Orlando Dermatology Aesthetic and Clinical Conference.

Anaphylaxis from alpha-gal syndrome is on the rise, caused in part by the geographic spread of the Lone Star tick. Beginning in 2006, isolated cases of an anaphylactic reaction to cetuximab, the epidermal growth factor receptor antagonist used to treat certain cancers, began to be seen in a curious geographic distribution. “The anaphylaxis cases were restricted to the southeastern United States, the home of the Lone Star tick,” said Dr. Finch, of the department of dermatology at the University of Connecticut, Farmington.

With some detective work, physicians and epidemiologists eventually determined that patients were reacting to an oligosaccharide called galactose-alpha–1,3-galactose (alpha-gal) found in cetuximab. This protein is also found in the meat of nonprimate mammals; individuals in the southeastern United States, where the Lone Star tick is endemic, had been sensitized via exposure to alpha-gal from Lone Star tick bites.

“Alpha-gal syndrome is on the rise,” said Dr. Finch, driven by the increased spread of this tick. Individuals who are sensitized develop delayed anaphylaxis 2-7 hours after ingesting red meat such as beef, pork, or lamb. “Ask about it,” said Dr. Finch, in patients who develop urticaria, dyspnea, angioedema, or hypotension without a clear offender. Because of the delay between allergen ingestion and anaphylaxis, it can be hard to connect the dots.


Understanding and Using Biosimilars

By Medical Dermatology, ODAC Sessions, Patient Care
Dr Leon Kircik at ODAC Dermatology Conference

Source: Dermatology Times

One of the only things the dermatology community knows about biosimilar use is that there are many unknowns. Still, biosimilars are on dermatologists’ radars as having the potential to lower the high costs of biologic treatments for chronic skin diseases, including psoriasis.

There also are misperceptions—even among dermatologists—about what biosimilars are and if these drugs can be used to treat patients, according to Leon H. Kircik, M.D., clinical associate professor of dermatology at Indiana University School of Medicine, Indianapolis; clinical associate professor of dermatology at Mount Sinai Medical Center, New York City; and medical director of Physicians Skin Care in Louisville, Ky. who presented “Biosimilars: What You Need to Know” at the Orlando Derm Aesthetic and Clinical conference in Miami, Fla., in January 2017.

Misperception number one

The first misperception is that biosimilars are generic biologics. They’re not, he says.

“You cannot have a generic of a biologic because every biologic is made differently. So, it is important for everybody to understand that biosimilars are not generics,” says Dr. Kircik,

As a result, the approval process for biosimilars is different for that of generics. Biosimilars came about because of the Biologics Price Competition and Innovation Act of 2009, which passed in Congress as a provision of the Affordable Care Act. Biosimilars have an abbreviated licensure pathway, but it’s a different pathway compared to a generic.

“Biopharmaceuticals are biopolymers of organic molecules that are manufactured in living systems. Function is based not only on the amino acid number and sequence but also on posttranslational modification (e.g. glycosylation) that are added by virtue of manufacture in living systems.”

Complexities and blurred lines

The FDA’s definition of a biosimilar, according to Dr. Kircik is, “A biological product that is highly similar to the reference product, notwithstanding minor differences in clinically inactive components. There are no clinically meaningful differences from the reference product in terms of the safety, purity, and potency”

“Those are very vague terms,” Dr. Kircik says.

The first biosimilar (not for use in dermatology), Zarxio [Sandoz], was FDA approved in March 2015. Zarxio is biosimilar to Neupogen (Amgen, filgrastim)1

More than a year later, the first biosimilar to have dermatologic indications received FDA approval—a biosimilar of infliximab, by the name of Inflectra (Celltrion). Interestingly, Inflectra, a biosimilar to Janssen Biotech’s Remicade, has an indication for psoriasis but no data on dermatologic disease, including psoriasis, Dr. Kircik says.

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FDA Approval: Corticosteroid-Sparing Topical for Eczema

By Medical Dermatology, ODAC Sessions, Patient Care
Dr. Friedman Presenting at the ODAC Dermatology Conference

Source: Dermatology Times

The FDA announced it has approved Eucrisa (Anacor Pharmaceuticals, crisaborole) ointment to treat mild to moderate eczema in patients two-years-of-age and older.

Applied twice daily, Eucrisa is a phosphodiesterase 4 (PDE-4) inhibitor. Its precise mechanism of action in atopic dermatitis, however, isn’t known, according to an FDA press release.

“We welcome this corticosteroid-sparing topical option,” says Elaine C. Siegfried, M.D., professor of pediatrics and dermatology at Saint Louis University, Cardinal Glennon Children’s Hospital, St. Louis, Mo. “The other two alternatives (pimecrolimus cream and tacrolimus ointment) carry black box warnings and labelled limitation on duration of use. Although most pediatric dermatologists prescribe these medications in infants and children without long-term safety concerns, prescribing Eucrisa is not hampered by this medicolegal burden. However, cost and access could be a limitation.”

Adam Friedman, M.D., associate professor of dermatology and director of translational research in dermatology at George Washington School of Medicine and Health Sciences, tells Dermatology Times that this most recent approval represents the exciting first of hopefully many new approved therapies for an exceedingly common disease state, which until recently was largely ignored.

“I envision crisaborole being used in a similar manner to calcineurin inhibitors, both as proactive treatment for affected delicate areas like the eyelids, face, body folds, groin or mild disease elsewhere. But, more importantly, [I envision it] as preventative maintenance therapy for disease areas that recur frequently after topical steroid use has been discontinued (though without the baggage of a black box warning and possible substance P induced burning at the onset of use),” he says.

Dr. Friedman, who is presenting on the topic of eczema at the January 16 to 19, 2017 Orlando Derm Aesthetic and Clinical conference in Miami, Fla., says this approval, however, should not overshadow the basic and requisite elements for properly managing this often chronic condition. These basics are: clear patient education on a broad range of topics, including realistic expectations; proper soap, moisturizer and treatment use; and myths about treatment safety, in order to gain the patient’s confidence, which in turn, increases the likelihood of regimen compliance, according to Dr. Friedman.

Taming Atopic Dermatitis and Managing Expectations

By Medical Dermatology, ODAC Sessions, Patient Care
Adam Friedman, MD faculty headshot

Source: Dermatology News

Tactics for managing patients with atopic dermatitis can go a long way to educate patients, set realistic expectations, and devise strategies for existing therapies, even as clinicians await some promising agents expected on the market soon.

“The good news is this is the Age of Eczema. In the last couple of years we’ve seen an explosion in the literature,” Adam Friedman, MD, of the department of dermatology, George Washington University, Washington, D.C., said at the Orlando Dermatology Aesthetic and Clinical Conference. Some of this research is spurring new therapeutics. a phosphodiesterase 4 inhibitor.

Crisaborole ointment, 2% (Eucrisa), a phosphodiesterase 4 inhibitor, was approved by the Food and Drug Administration in December 2016 for treating patients aged 2 years and older with mild to moderate AD, for example. It is a novel, nonsteroidal anti-inflammatory and the first prescription agent approved in the United States for atopic dermatitis in more than 10 years.

Dr. Friedman has no personal experience with crisaborole, which just became available. “But the data look encouraging. From what I’ve seen this may be a nonburning alternative to calcineurin inhibitors. It will be interesting to see how this will fit in our practices.”

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