Dermatology

Ecthyma is a more severe, ulcerated form of impetigo, a common dermatologic infection often caused by Staphylococcus aureus. Coinfection of staphylococci and streptococci can make it more challenging to treat. Lesions typically begin as a vesicle that enlarges and forms an ulcer with a hemorrhagic crust. Even with treatment, the depth of the lesions may result in scarring. Shins and dorsal feet are nearly always involved. Systemic involvement is rare.

Open wounds, bites, or dermatoses are risk factors for the development of ecthyma. Additionally, poor hygiene and malnutrition play a major role in inoculation and severity of the disease. Poor hygiene may serve as the initiating factor for infection, but malnutrition permits further development because of the body’s inability to mount a sufficient immune response. Intravenous drug users and patients with HIV tend to be affected.

When diagnosing ecthyma, it is important to correlate clinical signs with a bacterial culture. This condition can be difficult to treat because of both coinfection and growing antibiotic resistance in staphylococcal and streptococcal species. Specifically, S. aureus has been found to be resistant to beta-lactam antibiotics for many years, with methicillin-resistant S. aureus (MRSA) being first detected in 1961. While a variety of antibiotics are indicated, the prescription should be tailored to cover the cultured organism.

Topical antibiotics are sufficient for more superficial lesions. Both topical and oral antibiotics may be recommended for ecthyma as the infection can spread more deeply into the skin, eventually causing a cellulitis. Treatment protocol for oral agents varies based on which drug is indicated. This patient was seen in the emergency room. His white blood cell count was elevated at 9 × 10⁹/L. He was started empirically on amoxicillin/clavulanate (Augmentin) and ciprofloxacin. Bacterial cultures grew out Streptococcus pyogenes.
 

The case and photos were submitted by Lucas Shapiro, BS, Nova Southeastern University College of Osteopathic Medicine, Fort Lauderdale, Fla., and Susannah Berke, MD, Three Rivers Dermatology, Coraopolis, Pa. Dr. Bilu Martin edited the column. Dr. Bilu Martin is a board-certified dermatologist in private practice at Premier Dermatology, MD, in Aventura, Fla. More diagnostic cases are available at mdedge.com/dermatology. To submit a case for possible publication, send an email to [email protected].
 

References

1. Kwak Y et al. Infect Chemother. 2017 Dec;49(4):301-25.

2. Pereira LB. An Bras Dermatol. 2014 Mar-Apr;89(2):293-9.

3. Wasserzug O et al. Clin Infect Dis. 2009 May 1;48(9):1213-9.

Ecthyma is a more severe, ulcerated form of impetigo, a common dermatologic infection often caused by Staphylococcus aureus. Coinfection of staphylococci and streptococci can make it more challenging to treat. Lesions typically begin as a vesicle that enlarges and forms an ulcer with a hemorrhagic crust. Even with treatment, the depth of the lesions may result in scarring. Shins and dorsal feet are nearly always involved. Systemic involvement is rare.

Open wounds, bites, or dermatoses are risk factors for the development of ecthyma. Additionally, poor hygiene and malnutrition play a major role in inoculation and severity of the disease. Poor hygiene may serve as the initiating factor for infection, but malnutrition permits further development because of the body’s inability to mount a sufficient immune response. Intravenous drug users and patients with HIV tend to be affected.

When diagnosing ecthyma, it is important to correlate clinical signs with a bacterial culture. This condition can be difficult to treat because of both coinfection and growing antibiotic resistance in staphylococcal and streptococcal species. Specifically, S. aureus has been found to be resistant to beta-lactam antibiotics for many years, with methicillin-resistant S. aureus (MRSA) being first detected in 1961. While a variety of antibiotics are indicated, the prescription should be tailored to cover the cultured organism.

Topical antibiotics are sufficient for more superficial lesions. Both topical and oral antibiotics may be recommended for ecthyma as the infection can spread more deeply into the skin, eventually causing a cellulitis. Treatment protocol for oral agents varies based on which drug is indicated. This patient was seen in the emergency room. His white blood cell count was elevated at 9 × 10⁹/L. He was started empirically on amoxicillin/clavulanate (Augmentin) and ciprofloxacin. Bacterial cultures grew out Streptococcus pyogenes.
 

The case and photos were submitted by Lucas Shapiro, BS, Nova Southeastern University College of Osteopathic Medicine, Fort Lauderdale, Fla., and Susannah Berke, MD, Three Rivers Dermatology, Coraopolis, Pa. Dr. Bilu Martin edited the column. Dr. Bilu Martin is a board-certified dermatologist in private practice at Premier Dermatology, MD, in Aventura, Fla. More diagnostic cases are available at mdedge.com/dermatology. To submit a case for possible publication, send an email to [email protected].
 

References

1. Kwak Y et al. Infect Chemother. 2017 Dec;49(4):301-25.

2. Pereira LB. An Bras Dermatol. 2014 Mar-Apr;89(2):293-9.

3. Wasserzug O et al. Clin Infect Dis. 2009 May 1;48(9):1213-9.

Ecthyma is a more severe, ulcerated form of impetigo, a common dermatologic infection often caused by Staphylococcus aureus. Coinfection of staphylococci and streptococci can make it more challenging to treat. Lesions typically begin as a vesicle that enlarges and forms an ulcer with a hemorrhagic crust. Even with treatment, the depth of the lesions may result in scarring. Shins and dorsal feet are nearly always involved. Systemic involvement is rare.

Open wounds, bites, or dermatoses are risk factors for the development of ecthyma. Additionally, poor hygiene and malnutrition play a major role in inoculation and severity of the disease. Poor hygiene may serve as the initiating factor for infection, but malnutrition permits further development because of the body’s inability to mount a sufficient immune response. Intravenous drug users and patients with HIV tend to be affected.

When diagnosing ecthyma, it is important to correlate clinical signs with a bacterial culture. This condition can be difficult to treat because of both coinfection and growing antibiotic resistance in staphylococcal and streptococcal species. Specifically, S. aureus has been found to be resistant to beta-lactam antibiotics for many years, with methicillin-resistant S. aureus (MRSA) being first detected in 1961. While a variety of antibiotics are indicated, the prescription should be tailored to cover the cultured organism.

Topical antibiotics are sufficient for more superficial lesions. Both topical and oral antibiotics may be recommended for ecthyma as the infection can spread more deeply into the skin, eventually causing a cellulitis. Treatment protocol for oral agents varies based on which drug is indicated. This patient was seen in the emergency room. His white blood cell count was elevated at 9 × 10⁹/L. He was started empirically on amoxicillin/clavulanate (Augmentin) and ciprofloxacin. Bacterial cultures grew out Streptococcus pyogenes.
 

The case and photos were submitted by Lucas Shapiro, BS, Nova Southeastern University College of Osteopathic Medicine, Fort Lauderdale, Fla., and Susannah Berke, MD, Three Rivers Dermatology, Coraopolis, Pa. Dr. Bilu Martin edited the column. Dr. Bilu Martin is a board-certified dermatologist in private practice at Premier Dermatology, MD, in Aventura, Fla. More diagnostic cases are available at mdedge.com/dermatology. To submit a case for possible publication, send an email to [email protected].
 

References

1. Kwak Y et al. Infect Chemother. 2017 Dec;49(4):301-25.

2. Pereira LB. An Bras Dermatol. 2014 Mar-Apr;89(2):293-9.

3. Wasserzug O et al. Clin Infect Dis. 2009 May 1;48(9):1213-9.

I want to tell you a story about forgetfulness and haste, and how the combination of the two can lead to frightening consequences. A few years ago, I was lying in bed about to turn out the light when I realized I’d forgotten to take “my pill.”

Like some 161 million other American adults, I was then a consumer of a prescription medication. Being conscientious, I got up, retrieved said pill, and tossed it back. Being lazy, I didn’t bother to grab a glass of water to help the thing go down. Instead, I promptly returned to bed, threw a pillow over my head, and prepared for sleep.

Within seconds, I began to feel a burning sensation in my chest. After about a minute, that burn became a crippling pain. Not wanting to alarm my wife, I went into the living room, where I spent the next 30 minutes doubled over in agony. Was I having a heart attack? I phoned my sister, a hospitalist in Texas. She advised me to take myself to the ED to get checked out.

If only I’d known then about “Duke.” He could have told me how critical body posture is when people swallow pills.
 

Who’s Duke?

Duke is a computer representation of a 34-year-old, anatomically normal human male created by computer scientists at the IT’IS Foundation, a nonprofit group based in Switzerland that works on a variety of projects in health care technology. Using Duke, Rajat Mittal, PhD, a professor of medicine at the Johns Hopkins University, Baltimore, created a computer model called “StomachSim” to explore the process of digestion.

Their research, published in the journal Physics of Fluids, turned up several surprising findings about the dynamics of swallowing pills – the most common way medication is used worldwide.

Dr. Mittal said he chose to study the stomach because the functions of most other organ systems, from the heart to the brain, have already attracted plenty of attention from scientists.

“As I was looking to initiate research in some new directions, the implications of stomach biomechanics on important conditions such as diabetes, obesity, and gastroparesis became apparent to me,” he said. “It was clear that bioengineering research in this arena lags other more ‘sexy’ areas such as cardiovascular flows by at least 20 years, and there seemed to be a great opportunity to do impactful work.”
 

Your posture may help a pill work better

Several well-known things affect a pill’s ability to disperse its contents into the gut and be used by the body, such as the stomach’s contents (a heavy breakfast, a mix of liquids like juice, milk, and coffee) and the motion of the organ’s walls. But Dr. Mittal’s group learned that Duke’s posture also played a major role.

The researchers ran Duke through computer simulations in varying postures: upright, leaning right, leaning left, and leaning back, while keeping all the other parts of their analyses (like the things mentioned above) the same.

They found that posture determined as much as 83% of how quickly a pill disperses into the intestines. The most efficient position was leaning right. The least was leaning left, which prevented the pill from reaching the antrum, or bottom section of the stomach, and thus kept all but traces of the dissolved drug from entering the duodenum, where the stomach joins the small intestine. (Interestingly, Jews who observe Passover are advised to recline to the left during the meal as a symbol of freedom and leisure.)

That makes sense if you think about the stomach’s shape, which looks kind of like a bean, curving from the left to the right side of the body. Because of gravity, your position will change where the pill lands.

In the end, the researchers found that posture can be as significant a factor in how a pill dissolves as gastroparesis, a condition in which the stomach loses the ability to empty properly.
 

How this could help people

Among the groups most likely to benefit from such studies, Dr. Mittal said, are the elderly – who both take a lot of pills and are more prone to trouble swallowing because of age-related changes in their esophagus – and the bedridden, who can’t easily shift their posture. The findings may also lead to improvements in the ability to treat people with gastroparesis, a particular problem for people with diabetes.

Future studies with Duke and similar simulations will look at how the GI system digests proteins, carbohydrates, and fatty meals, Dr. Mittal said.

In the meantime, Dr. Mittal offered the following advice: “Standing or sitting upright after taking a pill is fine. If you have to take a pill lying down, stay on your back or on your right side. Avoid lying on your left side after taking a pill.”

As for what happened to me, any gastroenterologist reading this has figured out that my condition was not heart-related. Instead, I likely was having a bout of pill esophagitis, irritation that can result from medications that aggravate the mucosa of the food tube. Although painful, esophagitis isn’t life-threatening. After about an hour, the pain began to subside, and by the next morning I was fine, with only a faint ache in my chest to remind me of my earlier torment. (Researchers noted an increase in the condition early in the COVID-19 pandemic, linked to the antibiotic doxycycline.)

And, in the interest of accuracy, my pill problem began above the stomach. Nothing in the Hopkins research suggests that the alignment of the esophagus plays a role in how drugs disperse in the gut – unless, of course, it prevents those pills from reaching the stomach in the first place.

A version of this article first appeared on WebMD.com.

I want to tell you a story about forgetfulness and haste, and how the combination of the two can lead to frightening consequences. A few years ago, I was lying in bed about to turn out the light when I realized I’d forgotten to take “my pill.”

Like some 161 million other American adults, I was then a consumer of a prescription medication. Being conscientious, I got up, retrieved said pill, and tossed it back. Being lazy, I didn’t bother to grab a glass of water to help the thing go down. Instead, I promptly returned to bed, threw a pillow over my head, and prepared for sleep.

Within seconds, I began to feel a burning sensation in my chest. After about a minute, that burn became a crippling pain. Not wanting to alarm my wife, I went into the living room, where I spent the next 30 minutes doubled over in agony. Was I having a heart attack? I phoned my sister, a hospitalist in Texas. She advised me to take myself to the ED to get checked out.

If only I’d known then about “Duke.” He could have told me how critical body posture is when people swallow pills.
 

Who’s Duke?

Duke is a computer representation of a 34-year-old, anatomically normal human male created by computer scientists at the IT’IS Foundation, a nonprofit group based in Switzerland that works on a variety of projects in health care technology. Using Duke, Rajat Mittal, PhD, a professor of medicine at the Johns Hopkins University, Baltimore, created a computer model called “StomachSim” to explore the process of digestion.

Their research, published in the journal Physics of Fluids, turned up several surprising findings about the dynamics of swallowing pills – the most common way medication is used worldwide.

Dr. Mittal said he chose to study the stomach because the functions of most other organ systems, from the heart to the brain, have already attracted plenty of attention from scientists.

“As I was looking to initiate research in some new directions, the implications of stomach biomechanics on important conditions such as diabetes, obesity, and gastroparesis became apparent to me,” he said. “It was clear that bioengineering research in this arena lags other more ‘sexy’ areas such as cardiovascular flows by at least 20 years, and there seemed to be a great opportunity to do impactful work.”
 

Your posture may help a pill work better

Several well-known things affect a pill’s ability to disperse its contents into the gut and be used by the body, such as the stomach’s contents (a heavy breakfast, a mix of liquids like juice, milk, and coffee) and the motion of the organ’s walls. But Dr. Mittal’s group learned that Duke’s posture also played a major role.

The researchers ran Duke through computer simulations in varying postures: upright, leaning right, leaning left, and leaning back, while keeping all the other parts of their analyses (like the things mentioned above) the same.

They found that posture determined as much as 83% of how quickly a pill disperses into the intestines. The most efficient position was leaning right. The least was leaning left, which prevented the pill from reaching the antrum, or bottom section of the stomach, and thus kept all but traces of the dissolved drug from entering the duodenum, where the stomach joins the small intestine. (Interestingly, Jews who observe Passover are advised to recline to the left during the meal as a symbol of freedom and leisure.)

That makes sense if you think about the stomach’s shape, which looks kind of like a bean, curving from the left to the right side of the body. Because of gravity, your position will change where the pill lands.

In the end, the researchers found that posture can be as significant a factor in how a pill dissolves as gastroparesis, a condition in which the stomach loses the ability to empty properly.
 

How this could help people

Among the groups most likely to benefit from such studies, Dr. Mittal said, are the elderly – who both take a lot of pills and are more prone to trouble swallowing because of age-related changes in their esophagus – and the bedridden, who can’t easily shift their posture. The findings may also lead to improvements in the ability to treat people with gastroparesis, a particular problem for people with diabetes.

Future studies with Duke and similar simulations will look at how the GI system digests proteins, carbohydrates, and fatty meals, Dr. Mittal said.

In the meantime, Dr. Mittal offered the following advice: “Standing or sitting upright after taking a pill is fine. If you have to take a pill lying down, stay on your back or on your right side. Avoid lying on your left side after taking a pill.”

As for what happened to me, any gastroenterologist reading this has figured out that my condition was not heart-related. Instead, I likely was having a bout of pill esophagitis, irritation that can result from medications that aggravate the mucosa of the food tube. Although painful, esophagitis isn’t life-threatening. After about an hour, the pain began to subside, and by the next morning I was fine, with only a faint ache in my chest to remind me of my earlier torment. (Researchers noted an increase in the condition early in the COVID-19 pandemic, linked to the antibiotic doxycycline.)

And, in the interest of accuracy, my pill problem began above the stomach. Nothing in the Hopkins research suggests that the alignment of the esophagus plays a role in how drugs disperse in the gut – unless, of course, it prevents those pills from reaching the stomach in the first place.

A version of this article first appeared on WebMD.com.

I want to tell you a story about forgetfulness and haste, and how the combination of the two can lead to frightening consequences. A few years ago, I was lying in bed about to turn out the light when I realized I’d forgotten to take “my pill.”

Like some 161 million other American adults, I was then a consumer of a prescription medication. Being conscientious, I got up, retrieved said pill, and tossed it back. Being lazy, I didn’t bother to grab a glass of water to help the thing go down. Instead, I promptly returned to bed, threw a pillow over my head, and prepared for sleep.

Within seconds, I began to feel a burning sensation in my chest. After about a minute, that burn became a crippling pain. Not wanting to alarm my wife, I went into the living room, where I spent the next 30 minutes doubled over in agony. Was I having a heart attack? I phoned my sister, a hospitalist in Texas. She advised me to take myself to the ED to get checked out.

If only I’d known then about “Duke.” He could have told me how critical body posture is when people swallow pills.
 

Who’s Duke?

Duke is a computer representation of a 34-year-old, anatomically normal human male created by computer scientists at the IT’IS Foundation, a nonprofit group based in Switzerland that works on a variety of projects in health care technology. Using Duke, Rajat Mittal, PhD, a professor of medicine at the Johns Hopkins University, Baltimore, created a computer model called “StomachSim” to explore the process of digestion.

Their research, published in the journal Physics of Fluids, turned up several surprising findings about the dynamics of swallowing pills – the most common way medication is used worldwide.

Dr. Mittal said he chose to study the stomach because the functions of most other organ systems, from the heart to the brain, have already attracted plenty of attention from scientists.

“As I was looking to initiate research in some new directions, the implications of stomach biomechanics on important conditions such as diabetes, obesity, and gastroparesis became apparent to me,” he said. “It was clear that bioengineering research in this arena lags other more ‘sexy’ areas such as cardiovascular flows by at least 20 years, and there seemed to be a great opportunity to do impactful work.”
 

Your posture may help a pill work better

Several well-known things affect a pill’s ability to disperse its contents into the gut and be used by the body, such as the stomach’s contents (a heavy breakfast, a mix of liquids like juice, milk, and coffee) and the motion of the organ’s walls. But Dr. Mittal’s group learned that Duke’s posture also played a major role.

The researchers ran Duke through computer simulations in varying postures: upright, leaning right, leaning left, and leaning back, while keeping all the other parts of their analyses (like the things mentioned above) the same.

They found that posture determined as much as 83% of how quickly a pill disperses into the intestines. The most efficient position was leaning right. The least was leaning left, which prevented the pill from reaching the antrum, or bottom section of the stomach, and thus kept all but traces of the dissolved drug from entering the duodenum, where the stomach joins the small intestine. (Interestingly, Jews who observe Passover are advised to recline to the left during the meal as a symbol of freedom and leisure.)

That makes sense if you think about the stomach’s shape, which looks kind of like a bean, curving from the left to the right side of the body. Because of gravity, your position will change where the pill lands.

In the end, the researchers found that posture can be as significant a factor in how a pill dissolves as gastroparesis, a condition in which the stomach loses the ability to empty properly.
 

How this could help people

Among the groups most likely to benefit from such studies, Dr. Mittal said, are the elderly – who both take a lot of pills and are more prone to trouble swallowing because of age-related changes in their esophagus – and the bedridden, who can’t easily shift their posture. The findings may also lead to improvements in the ability to treat people with gastroparesis, a particular problem for people with diabetes.

Future studies with Duke and similar simulations will look at how the GI system digests proteins, carbohydrates, and fatty meals, Dr. Mittal said.

In the meantime, Dr. Mittal offered the following advice: “Standing or sitting upright after taking a pill is fine. If you have to take a pill lying down, stay on your back or on your right side. Avoid lying on your left side after taking a pill.”

As for what happened to me, any gastroenterologist reading this has figured out that my condition was not heart-related. Instead, I likely was having a bout of pill esophagitis, irritation that can result from medications that aggravate the mucosa of the food tube. Although painful, esophagitis isn’t life-threatening. After about an hour, the pain began to subside, and by the next morning I was fine, with only a faint ache in my chest to remind me of my earlier torment. (Researchers noted an increase in the condition early in the COVID-19 pandemic, linked to the antibiotic doxycycline.)

And, in the interest of accuracy, my pill problem began above the stomach. Nothing in the Hopkins research suggests that the alignment of the esophagus plays a role in how drugs disperse in the gut – unless, of course, it prevents those pills from reaching the stomach in the first place.

A version of this article first appeared on WebMD.com.

An analysis of postmarketing suicide data shows that the risk of suicide associated with brodalumab use is similar to that of other biologics prescribed for psoriasis.

The Food and Drug Administration approved brodalumab (Siliq) in 2017 for treatment of moderate to severe plaque psoriasis with a boxed warning for suicidal ideation and behavior and an associated Risk Evaluation and Mitigation Strategies (REMS) program indicating an increased risk of suicidality.

Half a decade later, “the available worldwide data do not support the notion that brodalumab has a unique risk of increased suicides,” senior investigator John Koo, MD, and coinvestigators at the University of California, San Francisco, wrote in a preproof article in JAAD International, noting that postmarketing data are “often considered a better reflection of real-world outcomes than clinical trials.”

The researchers extracted data through the end of 2021 on the number of completed suicides for brodalumab and ten other biologics approved for psoriasis from the FDA’s Adverse Events Reporting System (FAERS), an international publicly available database. The researchers included suicide data on the biologics for all indications.

The authors contacted pharmaceutical companies to determine the total number of patients prescribed each drug, securing mostly “best estimates” data on 5 of the 11 biologics available for psoriasis. The researchers then calculated the number of completed suicides per total number of prescribed patients.

For brodalumab, across 20,871 total prescriptions, there was only one verifiable suicide. It occurred in a Japanese man with terminal cancer and no nearby relatives 36 days after his first dose. The suicide rate for brodalumab was similar to that of ixekizumab, secukinumab, infliximab, and adalimumab.

“Brodalumab is a very efficacious agent and may have the fastest onset of action, yet its usage is minimal compared to the other agents because of this ‘black box’ warning ... despite the fact that it’s the least expensive of any biologic,” Dr. Koo, professor of dermatology and director of the Psoriasis and Skin Treatment Center, University of California, San Francisco, said in an interview.

Dr. Koo, who is board-certified in both dermatology and psychiatry, said he believes the boxed warning was never warranted. All three of the verified completed suicides that occurred during clinical trials of brodalumab for psoriasis were in people who had underlying psychiatric disorders or significant stressors, such as going to jail in one case, and depression and significant isolation in another, he said.

(An analysis of psychiatric adverse events during the psoriasis clinical trials, involving more than 4,000 patients, was published online Oct. 4, 2017, in the Journal of the American Academy of Dermatology.

George Han, MD, PhD, associate professor and director of research and teledermatology at the Zucker School of Medicine at Hofstra/Northwell, New Hyde Park, N.Y., who was not involved in the research, said the new data is reassuring.

“We sometimes put it into context [in thinking and counseling about risk] that in the trials for brodalumab, the number of suicide attempts [versus completed suicides] was not an outlier,” he said. “But it’s hard to know what to make of that, so this piece of knowledge that the postmarketing data show there’s no safety signal should give people a lot of reassurance.”

Dr. Han said he has used the medication, a fully human anti-interleukin 17 receptor A monoclonal antibody, in many patients who “have not done so well on other biologics and it’s been a lifesaver ... a couple who have switched over have maintained the longest level of clearance they’ve had with anything. It’s quite striking.”

The efficacy stems at least partly from its mechanism of blocking all cytokines in the IL-17 family – including those involved in the “feedback loops that perpetuate psoriasis” – rather than just one as other biologics do, Dr. Han said.

Usage of the drug has been hindered by the black box warning and REMS program, not only because of the extra steps required and hesitation potentially evoked, but because samples are not available, and because the “formulary access is not what it could have been otherwise,” he noted.

The Siliq REMS patient enrollment form requires patients to pledge awareness of the fact that suicidal thoughts and behaviors have occurred in treated patients and that they should seek medical attention if they experience suicidal thoughts or new or worsening depression, anxiety, or other mood changes. Prescribers must be certified with the program and must pledge on each enrollment form that they have counseled their patients.

The box warning states that there is no established causal association between treatment with brodalumab and increased risk for suicidal ideation and behaviors (SIB).

Individuals with psoriasis are an “already vulnerable population” who have been shown in reviews and meta-analyses to have a higher prevalence of depression and a higher risk of SIB than those without the disease, Dr. Koo and colleagues wrote in a narrative review published in Cutis .

Regardless of therapy, they wrote in the review, dermatologists should assess for any history of depression and SIB, and evaluate for signs and symptoms of current depression and SIB, referring patients as necessary to primary care or mental health care.

In the psoriasis trials, brodalumab treatment appeared to improve symptoms of depression and anxiety – a finding consistent with the effects reported for other biologic therapies, they wrote.

The first author on the newly published preproof is Samuel Yeroushalmi, BS, a fourth-year medical student at George Washington University, Washington.

Siliq is marketed by Valeant Pharmaceuticals.

Dr. Koo disclosed that he is an adviser/consultant/speaker for numerous pharmaceutical companies, but not those that were involved in the development of brodalumab. Dr. Han said he has relationships with numerous companies, including those that have developed brodalumab and other biologic agents used for psoriasis. The authors declared funding sources as none.

An analysis of postmarketing suicide data shows that the risk of suicide associated with brodalumab use is similar to that of other biologics prescribed for psoriasis.

The Food and Drug Administration approved brodalumab (Siliq) in 2017 for treatment of moderate to severe plaque psoriasis with a boxed warning for suicidal ideation and behavior and an associated Risk Evaluation and Mitigation Strategies (REMS) program indicating an increased risk of suicidality.

Half a decade later, “the available worldwide data do not support the notion that brodalumab has a unique risk of increased suicides,” senior investigator John Koo, MD, and coinvestigators at the University of California, San Francisco, wrote in a preproof article in JAAD International, noting that postmarketing data are “often considered a better reflection of real-world outcomes than clinical trials.”

The researchers extracted data through the end of 2021 on the number of completed suicides for brodalumab and ten other biologics approved for psoriasis from the FDA’s Adverse Events Reporting System (FAERS), an international publicly available database. The researchers included suicide data on the biologics for all indications.

The authors contacted pharmaceutical companies to determine the total number of patients prescribed each drug, securing mostly “best estimates” data on 5 of the 11 biologics available for psoriasis. The researchers then calculated the number of completed suicides per total number of prescribed patients.

For brodalumab, across 20,871 total prescriptions, there was only one verifiable suicide. It occurred in a Japanese man with terminal cancer and no nearby relatives 36 days after his first dose. The suicide rate for brodalumab was similar to that of ixekizumab, secukinumab, infliximab, and adalimumab.

“Brodalumab is a very efficacious agent and may have the fastest onset of action, yet its usage is minimal compared to the other agents because of this ‘black box’ warning ... despite the fact that it’s the least expensive of any biologic,” Dr. Koo, professor of dermatology and director of the Psoriasis and Skin Treatment Center, University of California, San Francisco, said in an interview.

Dr. Koo, who is board-certified in both dermatology and psychiatry, said he believes the boxed warning was never warranted. All three of the verified completed suicides that occurred during clinical trials of brodalumab for psoriasis were in people who had underlying psychiatric disorders or significant stressors, such as going to jail in one case, and depression and significant isolation in another, he said.

(An analysis of psychiatric adverse events during the psoriasis clinical trials, involving more than 4,000 patients, was published online Oct. 4, 2017, in the Journal of the American Academy of Dermatology.

George Han, MD, PhD, associate professor and director of research and teledermatology at the Zucker School of Medicine at Hofstra/Northwell, New Hyde Park, N.Y., who was not involved in the research, said the new data is reassuring.

“We sometimes put it into context [in thinking and counseling about risk] that in the trials for brodalumab, the number of suicide attempts [versus completed suicides] was not an outlier,” he said. “But it’s hard to know what to make of that, so this piece of knowledge that the postmarketing data show there’s no safety signal should give people a lot of reassurance.”

Dr. Han said he has used the medication, a fully human anti-interleukin 17 receptor A monoclonal antibody, in many patients who “have not done so well on other biologics and it’s been a lifesaver ... a couple who have switched over have maintained the longest level of clearance they’ve had with anything. It’s quite striking.”

The efficacy stems at least partly from its mechanism of blocking all cytokines in the IL-17 family – including those involved in the “feedback loops that perpetuate psoriasis” – rather than just one as other biologics do, Dr. Han said.

Usage of the drug has been hindered by the black box warning and REMS program, not only because of the extra steps required and hesitation potentially evoked, but because samples are not available, and because the “formulary access is not what it could have been otherwise,” he noted.

The Siliq REMS patient enrollment form requires patients to pledge awareness of the fact that suicidal thoughts and behaviors have occurred in treated patients and that they should seek medical attention if they experience suicidal thoughts or new or worsening depression, anxiety, or other mood changes. Prescribers must be certified with the program and must pledge on each enrollment form that they have counseled their patients.

The box warning states that there is no established causal association between treatment with brodalumab and increased risk for suicidal ideation and behaviors (SIB).

Individuals with psoriasis are an “already vulnerable population” who have been shown in reviews and meta-analyses to have a higher prevalence of depression and a higher risk of SIB than those without the disease, Dr. Koo and colleagues wrote in a narrative review published in Cutis .

Regardless of therapy, they wrote in the review, dermatologists should assess for any history of depression and SIB, and evaluate for signs and symptoms of current depression and SIB, referring patients as necessary to primary care or mental health care.

In the psoriasis trials, brodalumab treatment appeared to improve symptoms of depression and anxiety – a finding consistent with the effects reported for other biologic therapies, they wrote.

The first author on the newly published preproof is Samuel Yeroushalmi, BS, a fourth-year medical student at George Washington University, Washington.

Siliq is marketed by Valeant Pharmaceuticals.

Dr. Koo disclosed that he is an adviser/consultant/speaker for numerous pharmaceutical companies, but not those that were involved in the development of brodalumab. Dr. Han said he has relationships with numerous companies, including those that have developed brodalumab and other biologic agents used for psoriasis. The authors declared funding sources as none.

An analysis of postmarketing suicide data shows that the risk of suicide associated with brodalumab use is similar to that of other biologics prescribed for psoriasis.

The Food and Drug Administration approved brodalumab (Siliq) in 2017 for treatment of moderate to severe plaque psoriasis with a boxed warning for suicidal ideation and behavior and an associated Risk Evaluation and Mitigation Strategies (REMS) program indicating an increased risk of suicidality.

Half a decade later, “the available worldwide data do not support the notion that brodalumab has a unique risk of increased suicides,” senior investigator John Koo, MD, and coinvestigators at the University of California, San Francisco, wrote in a preproof article in JAAD International, noting that postmarketing data are “often considered a better reflection of real-world outcomes than clinical trials.”

The researchers extracted data through the end of 2021 on the number of completed suicides for brodalumab and ten other biologics approved for psoriasis from the FDA’s Adverse Events Reporting System (FAERS), an international publicly available database. The researchers included suicide data on the biologics for all indications.

The authors contacted pharmaceutical companies to determine the total number of patients prescribed each drug, securing mostly “best estimates” data on 5 of the 11 biologics available for psoriasis. The researchers then calculated the number of completed suicides per total number of prescribed patients.

For brodalumab, across 20,871 total prescriptions, there was only one verifiable suicide. It occurred in a Japanese man with terminal cancer and no nearby relatives 36 days after his first dose. The suicide rate for brodalumab was similar to that of ixekizumab, secukinumab, infliximab, and adalimumab.

“Brodalumab is a very efficacious agent and may have the fastest onset of action, yet its usage is minimal compared to the other agents because of this ‘black box’ warning ... despite the fact that it’s the least expensive of any biologic,” Dr. Koo, professor of dermatology and director of the Psoriasis and Skin Treatment Center, University of California, San Francisco, said in an interview.

Dr. Koo, who is board-certified in both dermatology and psychiatry, said he believes the boxed warning was never warranted. All three of the verified completed suicides that occurred during clinical trials of brodalumab for psoriasis were in people who had underlying psychiatric disorders or significant stressors, such as going to jail in one case, and depression and significant isolation in another, he said.

(An analysis of psychiatric adverse events during the psoriasis clinical trials, involving more than 4,000 patients, was published online Oct. 4, 2017, in the Journal of the American Academy of Dermatology.

George Han, MD, PhD, associate professor and director of research and teledermatology at the Zucker School of Medicine at Hofstra/Northwell, New Hyde Park, N.Y., who was not involved in the research, said the new data is reassuring.

“We sometimes put it into context [in thinking and counseling about risk] that in the trials for brodalumab, the number of suicide attempts [versus completed suicides] was not an outlier,” he said. “But it’s hard to know what to make of that, so this piece of knowledge that the postmarketing data show there’s no safety signal should give people a lot of reassurance.”

Dr. Han said he has used the medication, a fully human anti-interleukin 17 receptor A monoclonal antibody, in many patients who “have not done so well on other biologics and it’s been a lifesaver ... a couple who have switched over have maintained the longest level of clearance they’ve had with anything. It’s quite striking.”

The efficacy stems at least partly from its mechanism of blocking all cytokines in the IL-17 family – including those involved in the “feedback loops that perpetuate psoriasis” – rather than just one as other biologics do, Dr. Han said.

Usage of the drug has been hindered by the black box warning and REMS program, not only because of the extra steps required and hesitation potentially evoked, but because samples are not available, and because the “formulary access is not what it could have been otherwise,” he noted.

The Siliq REMS patient enrollment form requires patients to pledge awareness of the fact that suicidal thoughts and behaviors have occurred in treated patients and that they should seek medical attention if they experience suicidal thoughts or new or worsening depression, anxiety, or other mood changes. Prescribers must be certified with the program and must pledge on each enrollment form that they have counseled their patients.

The box warning states that there is no established causal association between treatment with brodalumab and increased risk for suicidal ideation and behaviors (SIB).

Individuals with psoriasis are an “already vulnerable population” who have been shown in reviews and meta-analyses to have a higher prevalence of depression and a higher risk of SIB than those without the disease, Dr. Koo and colleagues wrote in a narrative review published in Cutis .

Regardless of therapy, they wrote in the review, dermatologists should assess for any history of depression and SIB, and evaluate for signs and symptoms of current depression and SIB, referring patients as necessary to primary care or mental health care.

In the psoriasis trials, brodalumab treatment appeared to improve symptoms of depression and anxiety – a finding consistent with the effects reported for other biologic therapies, they wrote.

The first author on the newly published preproof is Samuel Yeroushalmi, BS, a fourth-year medical student at George Washington University, Washington.

Siliq is marketed by Valeant Pharmaceuticals.

Dr. Koo disclosed that he is an adviser/consultant/speaker for numerous pharmaceutical companies, but not those that were involved in the development of brodalumab. Dr. Han said he has relationships with numerous companies, including those that have developed brodalumab and other biologic agents used for psoriasis. The authors declared funding sources as none.

Additional hidradenitis suppurativa (HS) treatments could be on the horizon with the news that both secukinumab and the investigational drug brepocitinib reduced the effects of the chronic and painful skin condition in separate trials.

Around 40%-50% of patients exhibited a clinical response to these agents at 16 weeks, a leading HS expert reported at the annual congress of the European Academy of Dermatology and Venereology.
 

Time in the spotlight for HS

Research into HS is “an incredibly active field at this moment,” said Alexa B. Kimball, MD, MPH, professor of dermatology, Harvard Medical School, and president and chief executive officer of Harvard Medical Faculty Physicians at Beth Israel Deaconess Medical Center, Boston.

It’s “been great for advancing our understanding of the biology and the treatments that we will be able to use,” she said.

During the late-breaking sessions at the annual EADV Congress, Dr. Kimball presented data from two trials – SUNSHINE and SUNRISE – that investigated the efficacy, safety and tolerability of the interleukin (IL) 17A inhibitor secukinumab (Cosentyx) versus placebo in the treatment of moderate to severe HS.

“This is only the second phase 3 program we have ever seen in HS and the first one since 2016,” Dr. Kimball said of the trials. It’s also the largest trial program in HS conducted to date, she added, “so it really is a milestone.”

The last big development was when adalimumab, a tumor necrosis factor (TNF) blocker, gained regulatory approval for HS in 2016, observed Neil Patel, PhD, MRCP, who leads the HS service at Imperial College Healthcare NHS Trust in London.

“Adalimumab has been very helpful for many patients, but not all patients respond, and others may respond initially but then the treatment starts to fail after a year or 2,” Dr. Patel said in an interview with this news organization.

“There is definitely a huge need for alternative medication for this condition, which still has a lack of effective treatment options,” added Dr. Patel, who was not involved in either of the studies.

“One major upside for secukinumab is that its safety profile is generally very good and familiarity in the dermatologic community is already well established,” Christopher Sayed, MD, said in a separate interview.

“This will make most providers very comfortable offering it as a potential treatment option sooner rather than later given that its efficacy has now been demonstrated in phase 3 trials,” added Dr. Sayed, associate professor of dermatology at the University of North Carolina at Chapel Hill.
 

Two identically designed trials

Altogether, SUNSHINE and SUNRISE enrolled just over 1,000 patients at 219 sites in 33 countries. Both trials were identical in their design: A 4-week run-in phase before a randomized, double-blind treatment phase that tested two dosing regimens of secukinumab (300 mg administered subcutaneously) every 2 or 4 weeks vs. placebo for 16 weeks. The trial continued after this time, with patients in the placebo arm re–randomly assigned to treatment with one of the two secukinumab regimens out to a year.

The primary endpoint was the percentage of patients achieving a Hidradenitis Suppurativa Clinical Response (HiSCR) after 16 weeks of treatment, with key secondary endpoints, which were abscess and inflammatory nodule (AN) count, occurrence of flares, and at least a 30% reduction in Patient’s Global Assessment of Skin Pain assessed using a numeric rating scale (NPRS30).
 

Secukinumab superior to placebo

The HiSCR is defined as at least a 50% decrease in AN count with no increase in the number of abscesses or in the number of draining fistulas relative to baseline. This was achieved by about 42%-45% of patients who received secukinumab every 2 weeks, about 42%-46% of those who received secukinumab every 4 weeks, and about 31%-33% of those on placebo in both studies.

Of note, fewer patients treated with secukinumab (about 15%-20% among those treated every 2 weeks, and about 15% to 23% among those treated every 4 weeks) than those on placebo (27%-29%) experienced flares, defined as at least a 25% increase in AN count and at least a two-point increase relative to baseline values.

Improvement in HS pain can be a difficult parameter to meet, Dr. Kimball noted. “Pain is such an important feature of this disease as it so debilitating for the patients.” More than one-third (almost 36%-39%) of patients given secukinumab vs. just over a quarter (26.9%) given placebo achieved at least a 30% reduction in NPRS30 ratings, she reported. The difference between active and placebo treatment was significant only when secukinumab was given every 2 weeks, however.

“The placebo rates that we see in these studies are exactly parallel to what we saw in other studies, and other disease states when we had a 50% bar of improvement,” Dr. Kimball said when questioned about these results.

“HS is a highly variable disease; it’s maybe not so much the placebo rate or the scoring system used but maybe the 50% bar set for improvement is too low. It’s likely, as data start to mature and a 75% HiSCR can be calculated, that the placebo rates will drop,” she said.

There were no surprises when it came to the safety of secukinumab, being an old player in a new game, she noted. It was “well tolerated” and tolerability was “consistent with the known safety profile,” Dr. Kimball said, “so we expect it to be a new, safe, and effective add to our armamentarium in treating this disease.”

This research involves “basically borrowing drugs from other areas and trying them in HS to see what effect they may have,” Dr. Patel said, noting that drugs such as adalimumab and secukinumab already had a proven track record in other diseases, such as psoriasis. “These early data for secukinumab definitely are very exciting, but we would need to see real-life results” in patients with HS who are not enrolled in trials to see the benefits, he added.

‘Tipping point’ for HS research

“I think we will look back on this meeting and realize that it was an incredibly important tipping point for the treatment of this incredibly debilitating disease,” Dr. Kimball said.

Elsewhere at the meeting, she had presented findings from a phase 2a study that pitted three different kinase inhibitors with different modes of action against each other and compared them with placebo. 

The three agents evaluated are an IL-1 receptor–associated kinase 4 inhibitor known as PF-06650833, a tyrosine kinase 2 (TYK2) JAK1 inhibitor brepocitinib, and the TYK2 inhibitor PF-06826647.

“This technique has been used in oncology,” Dr. Kimball said, noting that the ability to test multiple drugs at the same time “means we can really much more efficiently test two different things at the same time, and also put fewer patients at risk for potential problems if drugs don’t work.”
 

Positive signs for brepocitinib, not the other kinases tested

The results showed that though brepocitinib worked in HS, the other two novel compounds did not appear to have beneficial effects. Just over half (52%) of the 52 patients treated with brepocitinib achieved an HiSCR at 16 weeks, compared with around one-third of those given placebo, PF-06650833, or PF-06826647.

A similar benefit was seen in terms of reduction in flares for brepocitinib but not the other agents, although there was no difference between them all in terms of NPRS30 pain reduction.

“We’ve been able to test three different modalities. This tells us some things about the pathophysiology for HS, which is a very profoundly intensive inflammatory process,” which, Dr. Kimball said, “may require multiple modalities of action to get it under control.” In addition, these “general modalities seem to safe and well tolerated,” she added.
 

Take-homes for practice and future research

“While it is disappointing that two of the drugs tested did not clearly demonstrate efficacy, it is very possible that these mechanisms of action may be successful targets in the future as new dosing strategies and drugs targeting these pathways are developed,” Dr. Sayed said.

A case in point, he added, was that “adalimumab did not meet treatment endpoints at a dose of 40 mg every other week, but clearly has made a major impact at 40 mg weekly.”

The bottom line is that “both secukinumab and beprocitinib demonstrated efficacy over placebo and are likely to be helpful for a significant number of patients with HS,” Dr. Sayed said. “Hopefully, we’ll see head-to-head trials and more data regarding proportions of patients with deeper responses using criteria such as HiSCR75 and HiSCR90.”

Moreover, “having a larger number of drugs with a range of mechanisms of action is extraordinarily helpful given how difficult the disease can be to manage. We will hopefully continue to see creative approaches and further successes in the current wave of phase 1, 2, and 3 trials that are already underway.”

The SUNSHINE and SUNRISE studies were funded by Novartis Pharma AG, Basel, Switzerland. The phase 2A study Dr. Kimball presented was sponsored by Pfizer.

Dr. Kimball disclosed ties to both Novartis and Pfizer and acts as a consultant and investigator to AbbVie, Bristol-Myers Squibb, Janssen, Eli Lilly, Novartis, and UCB. She is an investigator for Incyte and AnaptysBio; acts as a consultant to Bayer, Boehringer Ingelheim, Ventyz, Moonlake, Lily, Concert, EvoImmune, Sonoma Bio, and Sanofi; receives fellowship funding from Janssen, and serves on the Board of Directors for Almirall.

Dr. Patel had no conflicts of interest to disclose. Dr. Sayed is the director of the HS Foundation, a nonprofit organization, and has acted as an adviser or consultant to, speaker for, and received research funding from multiple drug companies including AbbVie, ChemoCentryx, Incyte, InflaRx, Novartis, and UCB.

A version of this article first appeared on Medscape.com.

Additional hidradenitis suppurativa (HS) treatments could be on the horizon with the news that both secukinumab and the investigational drug brepocitinib reduced the effects of the chronic and painful skin condition in separate trials.

Around 40%-50% of patients exhibited a clinical response to these agents at 16 weeks, a leading HS expert reported at the annual congress of the European Academy of Dermatology and Venereology.
 

Time in the spotlight for HS

Research into HS is “an incredibly active field at this moment,” said Alexa B. Kimball, MD, MPH, professor of dermatology, Harvard Medical School, and president and chief executive officer of Harvard Medical Faculty Physicians at Beth Israel Deaconess Medical Center, Boston.

It’s “been great for advancing our understanding of the biology and the treatments that we will be able to use,” she said.

During the late-breaking sessions at the annual EADV Congress, Dr. Kimball presented data from two trials – SUNSHINE and SUNRISE – that investigated the efficacy, safety and tolerability of the interleukin (IL) 17A inhibitor secukinumab (Cosentyx) versus placebo in the treatment of moderate to severe HS.

“This is only the second phase 3 program we have ever seen in HS and the first one since 2016,” Dr. Kimball said of the trials. It’s also the largest trial program in HS conducted to date, she added, “so it really is a milestone.”

The last big development was when adalimumab, a tumor necrosis factor (TNF) blocker, gained regulatory approval for HS in 2016, observed Neil Patel, PhD, MRCP, who leads the HS service at Imperial College Healthcare NHS Trust in London.

“Adalimumab has been very helpful for many patients, but not all patients respond, and others may respond initially but then the treatment starts to fail after a year or 2,” Dr. Patel said in an interview with this news organization.

“There is definitely a huge need for alternative medication for this condition, which still has a lack of effective treatment options,” added Dr. Patel, who was not involved in either of the studies.

“One major upside for secukinumab is that its safety profile is generally very good and familiarity in the dermatologic community is already well established,” Christopher Sayed, MD, said in a separate interview.

“This will make most providers very comfortable offering it as a potential treatment option sooner rather than later given that its efficacy has now been demonstrated in phase 3 trials,” added Dr. Sayed, associate professor of dermatology at the University of North Carolina at Chapel Hill.
 

Two identically designed trials

Altogether, SUNSHINE and SUNRISE enrolled just over 1,000 patients at 219 sites in 33 countries. Both trials were identical in their design: A 4-week run-in phase before a randomized, double-blind treatment phase that tested two dosing regimens of secukinumab (300 mg administered subcutaneously) every 2 or 4 weeks vs. placebo for 16 weeks. The trial continued after this time, with patients in the placebo arm re–randomly assigned to treatment with one of the two secukinumab regimens out to a year.

The primary endpoint was the percentage of patients achieving a Hidradenitis Suppurativa Clinical Response (HiSCR) after 16 weeks of treatment, with key secondary endpoints, which were abscess and inflammatory nodule (AN) count, occurrence of flares, and at least a 30% reduction in Patient’s Global Assessment of Skin Pain assessed using a numeric rating scale (NPRS30).
 

Secukinumab superior to placebo

The HiSCR is defined as at least a 50% decrease in AN count with no increase in the number of abscesses or in the number of draining fistulas relative to baseline. This was achieved by about 42%-45% of patients who received secukinumab every 2 weeks, about 42%-46% of those who received secukinumab every 4 weeks, and about 31%-33% of those on placebo in both studies.

Of note, fewer patients treated with secukinumab (about 15%-20% among those treated every 2 weeks, and about 15% to 23% among those treated every 4 weeks) than those on placebo (27%-29%) experienced flares, defined as at least a 25% increase in AN count and at least a two-point increase relative to baseline values.

Improvement in HS pain can be a difficult parameter to meet, Dr. Kimball noted. “Pain is such an important feature of this disease as it so debilitating for the patients.” More than one-third (almost 36%-39%) of patients given secukinumab vs. just over a quarter (26.9%) given placebo achieved at least a 30% reduction in NPRS30 ratings, she reported. The difference between active and placebo treatment was significant only when secukinumab was given every 2 weeks, however.

“The placebo rates that we see in these studies are exactly parallel to what we saw in other studies, and other disease states when we had a 50% bar of improvement,” Dr. Kimball said when questioned about these results.

“HS is a highly variable disease; it’s maybe not so much the placebo rate or the scoring system used but maybe the 50% bar set for improvement is too low. It’s likely, as data start to mature and a 75% HiSCR can be calculated, that the placebo rates will drop,” she said.

There were no surprises when it came to the safety of secukinumab, being an old player in a new game, she noted. It was “well tolerated” and tolerability was “consistent with the known safety profile,” Dr. Kimball said, “so we expect it to be a new, safe, and effective add to our armamentarium in treating this disease.”

This research involves “basically borrowing drugs from other areas and trying them in HS to see what effect they may have,” Dr. Patel said, noting that drugs such as adalimumab and secukinumab already had a proven track record in other diseases, such as psoriasis. “These early data for secukinumab definitely are very exciting, but we would need to see real-life results” in patients with HS who are not enrolled in trials to see the benefits, he added.

‘Tipping point’ for HS research

“I think we will look back on this meeting and realize that it was an incredibly important tipping point for the treatment of this incredibly debilitating disease,” Dr. Kimball said.

Elsewhere at the meeting, she had presented findings from a phase 2a study that pitted three different kinase inhibitors with different modes of action against each other and compared them with placebo. 

The three agents evaluated are an IL-1 receptor–associated kinase 4 inhibitor known as PF-06650833, a tyrosine kinase 2 (TYK2) JAK1 inhibitor brepocitinib, and the TYK2 inhibitor PF-06826647.

“This technique has been used in oncology,” Dr. Kimball said, noting that the ability to test multiple drugs at the same time “means we can really much more efficiently test two different things at the same time, and also put fewer patients at risk for potential problems if drugs don’t work.”
 

Positive signs for brepocitinib, not the other kinases tested

The results showed that though brepocitinib worked in HS, the other two novel compounds did not appear to have beneficial effects. Just over half (52%) of the 52 patients treated with brepocitinib achieved an HiSCR at 16 weeks, compared with around one-third of those given placebo, PF-06650833, or PF-06826647.

A similar benefit was seen in terms of reduction in flares for brepocitinib but not the other agents, although there was no difference between them all in terms of NPRS30 pain reduction.

“We’ve been able to test three different modalities. This tells us some things about the pathophysiology for HS, which is a very profoundly intensive inflammatory process,” which, Dr. Kimball said, “may require multiple modalities of action to get it under control.” In addition, these “general modalities seem to safe and well tolerated,” she added.
 

Take-homes for practice and future research

“While it is disappointing that two of the drugs tested did not clearly demonstrate efficacy, it is very possible that these mechanisms of action may be successful targets in the future as new dosing strategies and drugs targeting these pathways are developed,” Dr. Sayed said.

A case in point, he added, was that “adalimumab did not meet treatment endpoints at a dose of 40 mg every other week, but clearly has made a major impact at 40 mg weekly.”

The bottom line is that “both secukinumab and beprocitinib demonstrated efficacy over placebo and are likely to be helpful for a significant number of patients with HS,” Dr. Sayed said. “Hopefully, we’ll see head-to-head trials and more data regarding proportions of patients with deeper responses using criteria such as HiSCR75 and HiSCR90.”

Moreover, “having a larger number of drugs with a range of mechanisms of action is extraordinarily helpful given how difficult the disease can be to manage. We will hopefully continue to see creative approaches and further successes in the current wave of phase 1, 2, and 3 trials that are already underway.”

The SUNSHINE and SUNRISE studies were funded by Novartis Pharma AG, Basel, Switzerland. The phase 2A study Dr. Kimball presented was sponsored by Pfizer.

Dr. Kimball disclosed ties to both Novartis and Pfizer and acts as a consultant and investigator to AbbVie, Bristol-Myers Squibb, Janssen, Eli Lilly, Novartis, and UCB. She is an investigator for Incyte and AnaptysBio; acts as a consultant to Bayer, Boehringer Ingelheim, Ventyz, Moonlake, Lily, Concert, EvoImmune, Sonoma Bio, and Sanofi; receives fellowship funding from Janssen, and serves on the Board of Directors for Almirall.

Dr. Patel had no conflicts of interest to disclose. Dr. Sayed is the director of the HS Foundation, a nonprofit organization, and has acted as an adviser or consultant to, speaker for, and received research funding from multiple drug companies including AbbVie, ChemoCentryx, Incyte, InflaRx, Novartis, and UCB.

A version of this article first appeared on Medscape.com.

Additional hidradenitis suppurativa (HS) treatments could be on the horizon with the news that both secukinumab and the investigational drug brepocitinib reduced the effects of the chronic and painful skin condition in separate trials.

Around 40%-50% of patients exhibited a clinical response to these agents at 16 weeks, a leading HS expert reported at the annual congress of the European Academy of Dermatology and Venereology.
 

Time in the spotlight for HS

Research into HS is “an incredibly active field at this moment,” said Alexa B. Kimball, MD, MPH, professor of dermatology, Harvard Medical School, and president and chief executive officer of Harvard Medical Faculty Physicians at Beth Israel Deaconess Medical Center, Boston.

It’s “been great for advancing our understanding of the biology and the treatments that we will be able to use,” she said.

During the late-breaking sessions at the annual EADV Congress, Dr. Kimball presented data from two trials – SUNSHINE and SUNRISE – that investigated the efficacy, safety and tolerability of the interleukin (IL) 17A inhibitor secukinumab (Cosentyx) versus placebo in the treatment of moderate to severe HS.

“This is only the second phase 3 program we have ever seen in HS and the first one since 2016,” Dr. Kimball said of the trials. It’s also the largest trial program in HS conducted to date, she added, “so it really is a milestone.”

The last big development was when adalimumab, a tumor necrosis factor (TNF) blocker, gained regulatory approval for HS in 2016, observed Neil Patel, PhD, MRCP, who leads the HS service at Imperial College Healthcare NHS Trust in London.

“Adalimumab has been very helpful for many patients, but not all patients respond, and others may respond initially but then the treatment starts to fail after a year or 2,” Dr. Patel said in an interview with this news organization.

“There is definitely a huge need for alternative medication for this condition, which still has a lack of effective treatment options,” added Dr. Patel, who was not involved in either of the studies.

“One major upside for secukinumab is that its safety profile is generally very good and familiarity in the dermatologic community is already well established,” Christopher Sayed, MD, said in a separate interview.

“This will make most providers very comfortable offering it as a potential treatment option sooner rather than later given that its efficacy has now been demonstrated in phase 3 trials,” added Dr. Sayed, associate professor of dermatology at the University of North Carolina at Chapel Hill.
 

Two identically designed trials

Altogether, SUNSHINE and SUNRISE enrolled just over 1,000 patients at 219 sites in 33 countries. Both trials were identical in their design: A 4-week run-in phase before a randomized, double-blind treatment phase that tested two dosing regimens of secukinumab (300 mg administered subcutaneously) every 2 or 4 weeks vs. placebo for 16 weeks. The trial continued after this time, with patients in the placebo arm re–randomly assigned to treatment with one of the two secukinumab regimens out to a year.

The primary endpoint was the percentage of patients achieving a Hidradenitis Suppurativa Clinical Response (HiSCR) after 16 weeks of treatment, with key secondary endpoints, which were abscess and inflammatory nodule (AN) count, occurrence of flares, and at least a 30% reduction in Patient’s Global Assessment of Skin Pain assessed using a numeric rating scale (NPRS30).
 

Secukinumab superior to placebo

The HiSCR is defined as at least a 50% decrease in AN count with no increase in the number of abscesses or in the number of draining fistulas relative to baseline. This was achieved by about 42%-45% of patients who received secukinumab every 2 weeks, about 42%-46% of those who received secukinumab every 4 weeks, and about 31%-33% of those on placebo in both studies.

Of note, fewer patients treated with secukinumab (about 15%-20% among those treated every 2 weeks, and about 15% to 23% among those treated every 4 weeks) than those on placebo (27%-29%) experienced flares, defined as at least a 25% increase in AN count and at least a two-point increase relative to baseline values.

Improvement in HS pain can be a difficult parameter to meet, Dr. Kimball noted. “Pain is such an important feature of this disease as it so debilitating for the patients.” More than one-third (almost 36%-39%) of patients given secukinumab vs. just over a quarter (26.9%) given placebo achieved at least a 30% reduction in NPRS30 ratings, she reported. The difference between active and placebo treatment was significant only when secukinumab was given every 2 weeks, however.

“The placebo rates that we see in these studies are exactly parallel to what we saw in other studies, and other disease states when we had a 50% bar of improvement,” Dr. Kimball said when questioned about these results.

“HS is a highly variable disease; it’s maybe not so much the placebo rate or the scoring system used but maybe the 50% bar set for improvement is too low. It’s likely, as data start to mature and a 75% HiSCR can be calculated, that the placebo rates will drop,” she said.

There were no surprises when it came to the safety of secukinumab, being an old player in a new game, she noted. It was “well tolerated” and tolerability was “consistent with the known safety profile,” Dr. Kimball said, “so we expect it to be a new, safe, and effective add to our armamentarium in treating this disease.”

This research involves “basically borrowing drugs from other areas and trying them in HS to see what effect they may have,” Dr. Patel said, noting that drugs such as adalimumab and secukinumab already had a proven track record in other diseases, such as psoriasis. “These early data for secukinumab definitely are very exciting, but we would need to see real-life results” in patients with HS who are not enrolled in trials to see the benefits, he added.

‘Tipping point’ for HS research

“I think we will look back on this meeting and realize that it was an incredibly important tipping point for the treatment of this incredibly debilitating disease,” Dr. Kimball said.

Elsewhere at the meeting, she had presented findings from a phase 2a study that pitted three different kinase inhibitors with different modes of action against each other and compared them with placebo. 

The three agents evaluated are an IL-1 receptor–associated kinase 4 inhibitor known as PF-06650833, a tyrosine kinase 2 (TYK2) JAK1 inhibitor brepocitinib, and the TYK2 inhibitor PF-06826647.

“This technique has been used in oncology,” Dr. Kimball said, noting that the ability to test multiple drugs at the same time “means we can really much more efficiently test two different things at the same time, and also put fewer patients at risk for potential problems if drugs don’t work.”
 

Positive signs for brepocitinib, not the other kinases tested

The results showed that though brepocitinib worked in HS, the other two novel compounds did not appear to have beneficial effects. Just over half (52%) of the 52 patients treated with brepocitinib achieved an HiSCR at 16 weeks, compared with around one-third of those given placebo, PF-06650833, or PF-06826647.

A similar benefit was seen in terms of reduction in flares for brepocitinib but not the other agents, although there was no difference between them all in terms of NPRS30 pain reduction.

“We’ve been able to test three different modalities. This tells us some things about the pathophysiology for HS, which is a very profoundly intensive inflammatory process,” which, Dr. Kimball said, “may require multiple modalities of action to get it under control.” In addition, these “general modalities seem to safe and well tolerated,” she added.
 

Take-homes for practice and future research

“While it is disappointing that two of the drugs tested did not clearly demonstrate efficacy, it is very possible that these mechanisms of action may be successful targets in the future as new dosing strategies and drugs targeting these pathways are developed,” Dr. Sayed said.

A case in point, he added, was that “adalimumab did not meet treatment endpoints at a dose of 40 mg every other week, but clearly has made a major impact at 40 mg weekly.”

The bottom line is that “both secukinumab and beprocitinib demonstrated efficacy over placebo and are likely to be helpful for a significant number of patients with HS,” Dr. Sayed said. “Hopefully, we’ll see head-to-head trials and more data regarding proportions of patients with deeper responses using criteria such as HiSCR75 and HiSCR90.”

Moreover, “having a larger number of drugs with a range of mechanisms of action is extraordinarily helpful given how difficult the disease can be to manage. We will hopefully continue to see creative approaches and further successes in the current wave of phase 1, 2, and 3 trials that are already underway.”

The SUNSHINE and SUNRISE studies were funded by Novartis Pharma AG, Basel, Switzerland. The phase 2A study Dr. Kimball presented was sponsored by Pfizer.

Dr. Kimball disclosed ties to both Novartis and Pfizer and acts as a consultant and investigator to AbbVie, Bristol-Myers Squibb, Janssen, Eli Lilly, Novartis, and UCB. She is an investigator for Incyte and AnaptysBio; acts as a consultant to Bayer, Boehringer Ingelheim, Ventyz, Moonlake, Lily, Concert, EvoImmune, Sonoma Bio, and Sanofi; receives fellowship funding from Janssen, and serves on the Board of Directors for Almirall.

Dr. Patel had no conflicts of interest to disclose. Dr. Sayed is the director of the HS Foundation, a nonprofit organization, and has acted as an adviser or consultant to, speaker for, and received research funding from multiple drug companies including AbbVie, ChemoCentryx, Incyte, InflaRx, Novartis, and UCB.

A version of this article first appeared on Medscape.com.

PORTLAND, ORE. – Some pernio-like/chilblains-like lesions on the toes – which became widely known as “COVID toes” – and other acral sites that have occurred during the COVID-19 pandemic are related to COVID-19 infection, while others are not, according to Lindy P. Fox, MD, professor of dermatology and director of the hospital consultation service at the University of California, San Francisco.

“We’re learning a lot about pernio because of COVID,” Dr. Fox, a member of the American Academy of Dermatology’s Ad Hoc Task Force on COVID-19, said at the annual meeting of the Pacific Dermatologic Association. “Patients with pernio tend to either have bright red or purple individual lesions or an erythromelalgia-like presentation, often waking up in the middle of the night saying ‘my feet hurt. I can’t put sheets over my feet.’ In my experience, the patients with an erythromelalgia-like presentation tend to be a lot harder to treat.”

courtesy UCSF

Establishing terminology to describe pernio-like lesions was a challenge in the early stages of the COVID-19 pandemic, Dr. Fox added, with clinicians using terms like erythema multiforme-like, coxsackie-like, or even necrotic to describe the lesions. “I don’t think pernio is truly necrotic; I think it’s really inflammatory and purpuric,” she said.

Early in the pandemic, studies suggesting a link with these cases and COVID-19 infection include a case series of 318 patients with pernio-like skin lesions who had confirmed or suspected COVID-19. Most of these patients were generally young and healthy and most had relatively mild COVID-19; 7% were laboratory-confirmed COVID-19 positive, and 6% were close contacts of patients with confirmed COVID-19. Pernio-like lesions were the only symptoms in 55% of the patients.

In another study, researchers in France evaluated the clinical, laboratory, and pathologic characteristics of 40 patients who developed chilblain-like lesions (mostly involving the toes) during the COVID-19 pandemic and were seen as outpatients in April 2020 . All were polymerase chain reaction (PCR) negative, 30% were SARS-CoV-2 serology positive, and 60% had elevated D-dimers. Histology obtained from 19 of the patients revealed lymphocytic inflammation and vascular damage, and 8 had IgA positivity.

In a retrospective analysis of seven pediatric chilblains cases during the pandemic, researchers examined the skin biopsies to evaluate histopathological features and explored the presence of SARS-CoV-2 in the tissue. All patients were PCR negative. The authors observed cytoplasmic granular positivity for SARS-CoV-2 spike protein in endothelial cells, a feature that they said showed coronavirus-like particles, consistent with SARS-CoV-2.

Not all studies in the medical literature have demonstrated an association between pernio-like/chilblains-like lesions and COVID-19, though. An analysis of 23 patients, with skin eruptions considered associated with SARS-CoV-2 infections (including 21 cases of chilblains) during the first wave of the pandemic found that the antibody and T-cell response in patients with pandemic chilblains was the same as in negative controls.

“What’s remarkably interesting about this study is that they did autopsies of samples from patients who had died prepandemic, so there was no such thing as COVID-19,” said Dr. Fox, who was not involved with the study. “They stained for viral particles in those patients, and they were positive in a subset of patients. This makes me wonder about what the significance of that staining positivity is.”

Yet another group of investigators looked at what was happening with pernio during the waves of COVID in a study of chilblains cases in children in Spain, and found a stronger association between lockdown and cold temperature, which argues against a direct association between pernio and COVID infection.

In Dr. Fox’s experience, COVID toes can recur, especially upon exposure to cold. “What taught me this in real life is a patient who I saw remotely by video,” she recalled. “It was early on in the pandemic. I could not prove he had COVID no matter how hard I tried, but I do think he had COVID toes at that time.” When he later was confirmed to have COVID, “he got pernio in the same exact location as his original suspected COVID toes.”

According to an analysis of long COVID in the skin, based on cases reported to the American Academy of Dermatology–International League of Dermatological Societies registry from April 8 to Oct. 8, 2020, pernio-like lesions lasted a median of 12 days in patients with lab-confirmed COVID-19 and a median of 15 days in those with suspected COVID-19. But almost 7% of the 103 pernio cases were long-haulers, defined as those with dermatologic signs of COVID that lasted beyond 60 days.

“There are some patients who are resistant to treatment,” Dr. Fox said. “In addition, recurrent lesions make me think that maybe all pernio is triggered by some viral cause. This causes an immunologic phenomenon that’s responding to a viral trigger you’re trying to deal with. That may be the better way to think about COVID toes.”

Different variants of COVID also appear to be changing the characteristics of dermatologic manifestations associated with infection. Results from a large retrospective analysis of nearly 350,000 users of a COVID study App in the United Kingdom found that skin lesions were more predictive of a positive test in the Delta wave, compared with the Omicron wave, while pernio-like lesions were predictive of infection in the Delta wave but not in the Omicron wave.

“And, whether you were vaccinated or unvaccinated really did not influence whether or not you were going to have a skin rash as a presenting sign of COVID, except for the burning rash, which was less in vaccinated patients,” said Dr. Fox, who was not involved with the study.

Dr. Fox reported having no relevant disclosures.

PORTLAND, ORE. – Some pernio-like/chilblains-like lesions on the toes – which became widely known as “COVID toes” – and other acral sites that have occurred during the COVID-19 pandemic are related to COVID-19 infection, while others are not, according to Lindy P. Fox, MD, professor of dermatology and director of the hospital consultation service at the University of California, San Francisco.

“We’re learning a lot about pernio because of COVID,” Dr. Fox, a member of the American Academy of Dermatology’s Ad Hoc Task Force on COVID-19, said at the annual meeting of the Pacific Dermatologic Association. “Patients with pernio tend to either have bright red or purple individual lesions or an erythromelalgia-like presentation, often waking up in the middle of the night saying ‘my feet hurt. I can’t put sheets over my feet.’ In my experience, the patients with an erythromelalgia-like presentation tend to be a lot harder to treat.”

courtesy UCSF

Establishing terminology to describe pernio-like lesions was a challenge in the early stages of the COVID-19 pandemic, Dr. Fox added, with clinicians using terms like erythema multiforme-like, coxsackie-like, or even necrotic to describe the lesions. “I don’t think pernio is truly necrotic; I think it’s really inflammatory and purpuric,” she said.

Early in the pandemic, studies suggesting a link with these cases and COVID-19 infection include a case series of 318 patients with pernio-like skin lesions who had confirmed or suspected COVID-19. Most of these patients were generally young and healthy and most had relatively mild COVID-19; 7% were laboratory-confirmed COVID-19 positive, and 6% were close contacts of patients with confirmed COVID-19. Pernio-like lesions were the only symptoms in 55% of the patients.

In another study, researchers in France evaluated the clinical, laboratory, and pathologic characteristics of 40 patients who developed chilblain-like lesions (mostly involving the toes) during the COVID-19 pandemic and were seen as outpatients in April 2020 . All were polymerase chain reaction (PCR) negative, 30% were SARS-CoV-2 serology positive, and 60% had elevated D-dimers. Histology obtained from 19 of the patients revealed lymphocytic inflammation and vascular damage, and 8 had IgA positivity.

In a retrospective analysis of seven pediatric chilblains cases during the pandemic, researchers examined the skin biopsies to evaluate histopathological features and explored the presence of SARS-CoV-2 in the tissue. All patients were PCR negative. The authors observed cytoplasmic granular positivity for SARS-CoV-2 spike protein in endothelial cells, a feature that they said showed coronavirus-like particles, consistent with SARS-CoV-2.

Not all studies in the medical literature have demonstrated an association between pernio-like/chilblains-like lesions and COVID-19, though. An analysis of 23 patients, with skin eruptions considered associated with SARS-CoV-2 infections (including 21 cases of chilblains) during the first wave of the pandemic found that the antibody and T-cell response in patients with pandemic chilblains was the same as in negative controls.

“What’s remarkably interesting about this study is that they did autopsies of samples from patients who had died prepandemic, so there was no such thing as COVID-19,” said Dr. Fox, who was not involved with the study. “They stained for viral particles in those patients, and they were positive in a subset of patients. This makes me wonder about what the significance of that staining positivity is.”

Yet another group of investigators looked at what was happening with pernio during the waves of COVID in a study of chilblains cases in children in Spain, and found a stronger association between lockdown and cold temperature, which argues against a direct association between pernio and COVID infection.

In Dr. Fox’s experience, COVID toes can recur, especially upon exposure to cold. “What taught me this in real life is a patient who I saw remotely by video,” she recalled. “It was early on in the pandemic. I could not prove he had COVID no matter how hard I tried, but I do think he had COVID toes at that time.” When he later was confirmed to have COVID, “he got pernio in the same exact location as his original suspected COVID toes.”

According to an analysis of long COVID in the skin, based on cases reported to the American Academy of Dermatology–International League of Dermatological Societies registry from April 8 to Oct. 8, 2020, pernio-like lesions lasted a median of 12 days in patients with lab-confirmed COVID-19 and a median of 15 days in those with suspected COVID-19. But almost 7% of the 103 pernio cases were long-haulers, defined as those with dermatologic signs of COVID that lasted beyond 60 days.

“There are some patients who are resistant to treatment,” Dr. Fox said. “In addition, recurrent lesions make me think that maybe all pernio is triggered by some viral cause. This causes an immunologic phenomenon that’s responding to a viral trigger you’re trying to deal with. That may be the better way to think about COVID toes.”

Different variants of COVID also appear to be changing the characteristics of dermatologic manifestations associated with infection. Results from a large retrospective analysis of nearly 350,000 users of a COVID study App in the United Kingdom found that skin lesions were more predictive of a positive test in the Delta wave, compared with the Omicron wave, while pernio-like lesions were predictive of infection in the Delta wave but not in the Omicron wave.

“And, whether you were vaccinated or unvaccinated really did not influence whether or not you were going to have a skin rash as a presenting sign of COVID, except for the burning rash, which was less in vaccinated patients,” said Dr. Fox, who was not involved with the study.

Dr. Fox reported having no relevant disclosures.

PORTLAND, ORE. – Some pernio-like/chilblains-like lesions on the toes – which became widely known as “COVID toes” – and other acral sites that have occurred during the COVID-19 pandemic are related to COVID-19 infection, while others are not, according to Lindy P. Fox, MD, professor of dermatology and director of the hospital consultation service at the University of California, San Francisco.

“We’re learning a lot about pernio because of COVID,” Dr. Fox, a member of the American Academy of Dermatology’s Ad Hoc Task Force on COVID-19, said at the annual meeting of the Pacific Dermatologic Association. “Patients with pernio tend to either have bright red or purple individual lesions or an erythromelalgia-like presentation, often waking up in the middle of the night saying ‘my feet hurt. I can’t put sheets over my feet.’ In my experience, the patients with an erythromelalgia-like presentation tend to be a lot harder to treat.”

courtesy UCSF

Establishing terminology to describe pernio-like lesions was a challenge in the early stages of the COVID-19 pandemic, Dr. Fox added, with clinicians using terms like erythema multiforme-like, coxsackie-like, or even necrotic to describe the lesions. “I don’t think pernio is truly necrotic; I think it’s really inflammatory and purpuric,” she said.

Early in the pandemic, studies suggesting a link with these cases and COVID-19 infection include a case series of 318 patients with pernio-like skin lesions who had confirmed or suspected COVID-19. Most of these patients were generally young and healthy and most had relatively mild COVID-19; 7% were laboratory-confirmed COVID-19 positive, and 6% were close contacts of patients with confirmed COVID-19. Pernio-like lesions were the only symptoms in 55% of the patients.

In another study, researchers in France evaluated the clinical, laboratory, and pathologic characteristics of 40 patients who developed chilblain-like lesions (mostly involving the toes) during the COVID-19 pandemic and were seen as outpatients in April 2020 . All were polymerase chain reaction (PCR) negative, 30% were SARS-CoV-2 serology positive, and 60% had elevated D-dimers. Histology obtained from 19 of the patients revealed lymphocytic inflammation and vascular damage, and 8 had IgA positivity.

In a retrospective analysis of seven pediatric chilblains cases during the pandemic, researchers examined the skin biopsies to evaluate histopathological features and explored the presence of SARS-CoV-2 in the tissue. All patients were PCR negative. The authors observed cytoplasmic granular positivity for SARS-CoV-2 spike protein in endothelial cells, a feature that they said showed coronavirus-like particles, consistent with SARS-CoV-2.

Not all studies in the medical literature have demonstrated an association between pernio-like/chilblains-like lesions and COVID-19, though. An analysis of 23 patients, with skin eruptions considered associated with SARS-CoV-2 infections (including 21 cases of chilblains) during the first wave of the pandemic found that the antibody and T-cell response in patients with pandemic chilblains was the same as in negative controls.

“What’s remarkably interesting about this study is that they did autopsies of samples from patients who had died prepandemic, so there was no such thing as COVID-19,” said Dr. Fox, who was not involved with the study. “They stained for viral particles in those patients, and they were positive in a subset of patients. This makes me wonder about what the significance of that staining positivity is.”

Yet another group of investigators looked at what was happening with pernio during the waves of COVID in a study of chilblains cases in children in Spain, and found a stronger association between lockdown and cold temperature, which argues against a direct association between pernio and COVID infection.

In Dr. Fox’s experience, COVID toes can recur, especially upon exposure to cold. “What taught me this in real life is a patient who I saw remotely by video,” she recalled. “It was early on in the pandemic. I could not prove he had COVID no matter how hard I tried, but I do think he had COVID toes at that time.” When he later was confirmed to have COVID, “he got pernio in the same exact location as his original suspected COVID toes.”

According to an analysis of long COVID in the skin, based on cases reported to the American Academy of Dermatology–International League of Dermatological Societies registry from April 8 to Oct. 8, 2020, pernio-like lesions lasted a median of 12 days in patients with lab-confirmed COVID-19 and a median of 15 days in those with suspected COVID-19. But almost 7% of the 103 pernio cases were long-haulers, defined as those with dermatologic signs of COVID that lasted beyond 60 days.

“There are some patients who are resistant to treatment,” Dr. Fox said. “In addition, recurrent lesions make me think that maybe all pernio is triggered by some viral cause. This causes an immunologic phenomenon that’s responding to a viral trigger you’re trying to deal with. That may be the better way to think about COVID toes.”

Different variants of COVID also appear to be changing the characteristics of dermatologic manifestations associated with infection. Results from a large retrospective analysis of nearly 350,000 users of a COVID study App in the United Kingdom found that skin lesions were more predictive of a positive test in the Delta wave, compared with the Omicron wave, while pernio-like lesions were predictive of infection in the Delta wave but not in the Omicron wave.

“And, whether you were vaccinated or unvaccinated really did not influence whether or not you were going to have a skin rash as a presenting sign of COVID, except for the burning rash, which was less in vaccinated patients,” said Dr. Fox, who was not involved with the study.

Dr. Fox reported having no relevant disclosures.

THE COMPARISON

Severe longstanding hidradenitis suppurativa (Hurley stage III) with architectural changes, ropy scarring, granulation tissue, and purulent discharge in the axilla of

A A 35-year-old Black man.

B A 42-year-old Hispanic woman with a light skin tone.

Hidradenitis suppurativa (HS) is a chronic inflammatory condition of the follicular epithelium that most commonly is found in the axillae and buttocks, as well as the inguinal, perianal, and submammary areas. It is characterized by firm and tender chronic nodules, abscesses complicated by sinus tracts, fistulae, and scarring thought to be related to follicular occlusion. Double-open comedones also may be seen.

The Hurley staging system is widely used to characterize the extent of disease in patients with HS:

• Stage I (mild): nodule(s) and abscess(es) without sinus tracts (tunnels) or scarring;
• Stage II (moderate): recurrent nodule(s) and abscess(es) with a limited number of sinus tracts and/or scarring; and
• Stage III (severe): multiple or extensive sinus tracts, abscesses, and/or scarring across the entire area.

Epidemiology

HS is most common in adults and African American patients. It has a prevalence of 1.3% in African Americans.¹ When it occurs in children, it generally develops after the onset of puberty. The incidence is higher in females as well as individuals with a history of smoking and obesity (a higher body mass index).^2-5

Key clinical features in people with darker skin tones

The erythema associated with HS may be difficult to see in darker skin tones, but violaceous, dark brown, and gray lesions may be present. When active HS lesions subside, intense hyperpigmentation may be left behind, and in some skin tones a pink or violaceous lesion may be apparent.

Worth noting

HS is disfiguring and has a negative impact on quality of life, including social relationships. Mental health support and screening tools are useful. Pain also is a common concern and may warrant referral to a pain specialist.⁶ In early disease, HS lesions can be misdiagnosed as an infection that recurs in the same location.

Treatments for HS include oral antibiotics (ie, tetracyclines, rifampin, clindamycin), topical antibiotics, immunosuppressing biologics, metformin, and spironolactone.⁷ Surgical interventions may be considered earlier in HS management and vary based on the location and severity of the lesions.⁸

Patients with HS are at risk for developing squamous cell carcinoma in scars, even many years later⁹; therefore, patients should perform skin checks and be referred to a dermatologist. Squamous cell carcinoma is most commonly found on the buttocks of men with HS and has a poor prognosis.

Health disparity highlight

Although those of African American and African descent have the highest rates of HS,¹ the clinical trials for adalimumab (the only biologic approved for HS) enrolled a low number of Black patients.

Thirty HS comorbidities have been identified. Garg et al¹⁰ recommended that dermatologists perform examinations for comorbid conditions involving the skin and conduct a simple review of systems for extracutaneous comorbidities. Access to medical care is essential, and health care system barriers affect the ability of some patients to receive adequate continuity of care.

The diagnosis of HS often is delayed due to a lack of knowledge about the condition in the medical community at large and delayed presentation to a dermatologist.

THE COMPARISON

Severe longstanding hidradenitis suppurativa (Hurley stage III) with architectural changes, ropy scarring, granulation tissue, and purulent discharge in the axilla of

A A 35-year-old Black man.

B A 42-year-old Hispanic woman with a light skin tone.

Hidradenitis suppurativa (HS) is a chronic inflammatory condition of the follicular epithelium that most commonly is found in the axillae and buttocks, as well as the inguinal, perianal, and submammary areas. It is characterized by firm and tender chronic nodules, abscesses complicated by sinus tracts, fistulae, and scarring thought to be related to follicular occlusion. Double-open comedones also may be seen.

The Hurley staging system is widely used to characterize the extent of disease in patients with HS:

• Stage I (mild): nodule(s) and abscess(es) without sinus tracts (tunnels) or scarring;
• Stage II (moderate): recurrent nodule(s) and abscess(es) with a limited number of sinus tracts and/or scarring; and
• Stage III (severe): multiple or extensive sinus tracts, abscesses, and/or scarring across the entire area.

Epidemiology

HS is most common in adults and African American patients. It has a prevalence of 1.3% in African Americans.¹ When it occurs in children, it generally develops after the onset of puberty. The incidence is higher in females as well as individuals with a history of smoking and obesity (a higher body mass index).^2-5

Key clinical features in people with darker skin tones

The erythema associated with HS may be difficult to see in darker skin tones, but violaceous, dark brown, and gray lesions may be present. When active HS lesions subside, intense hyperpigmentation may be left behind, and in some skin tones a pink or violaceous lesion may be apparent.

Worth noting

HS is disfiguring and has a negative impact on quality of life, including social relationships. Mental health support and screening tools are useful. Pain also is a common concern and may warrant referral to a pain specialist.⁶ In early disease, HS lesions can be misdiagnosed as an infection that recurs in the same location.

Treatments for HS include oral antibiotics (ie, tetracyclines, rifampin, clindamycin), topical antibiotics, immunosuppressing biologics, metformin, and spironolactone.⁷ Surgical interventions may be considered earlier in HS management and vary based on the location and severity of the lesions.⁸

Patients with HS are at risk for developing squamous cell carcinoma in scars, even many years later⁹; therefore, patients should perform skin checks and be referred to a dermatologist. Squamous cell carcinoma is most commonly found on the buttocks of men with HS and has a poor prognosis.

Health disparity highlight

Although those of African American and African descent have the highest rates of HS,¹ the clinical trials for adalimumab (the only biologic approved for HS) enrolled a low number of Black patients.

Thirty HS comorbidities have been identified. Garg et al¹⁰ recommended that dermatologists perform examinations for comorbid conditions involving the skin and conduct a simple review of systems for extracutaneous comorbidities. Access to medical care is essential, and health care system barriers affect the ability of some patients to receive adequate continuity of care.

The diagnosis of HS often is delayed due to a lack of knowledge about the condition in the medical community at large and delayed presentation to a dermatologist.

THE COMPARISON

Severe longstanding hidradenitis suppurativa (Hurley stage III) with architectural changes, ropy scarring, granulation tissue, and purulent discharge in the axilla of

A A 35-year-old Black man.

B A 42-year-old Hispanic woman with a light skin tone.

Hidradenitis suppurativa (HS) is a chronic inflammatory condition of the follicular epithelium that most commonly is found in the axillae and buttocks, as well as the inguinal, perianal, and submammary areas. It is characterized by firm and tender chronic nodules, abscesses complicated by sinus tracts, fistulae, and scarring thought to be related to follicular occlusion. Double-open comedones also may be seen.

The Hurley staging system is widely used to characterize the extent of disease in patients with HS:

• Stage I (mild): nodule(s) and abscess(es) without sinus tracts (tunnels) or scarring;
• Stage II (moderate): recurrent nodule(s) and abscess(es) with a limited number of sinus tracts and/or scarring; and
• Stage III (severe): multiple or extensive sinus tracts, abscesses, and/or scarring across the entire area.

Epidemiology

HS is most common in adults and African American patients. It has a prevalence of 1.3% in African Americans.¹ When it occurs in children, it generally develops after the onset of puberty. The incidence is higher in females as well as individuals with a history of smoking and obesity (a higher body mass index).^2-5

Key clinical features in people with darker skin tones

The erythema associated with HS may be difficult to see in darker skin tones, but violaceous, dark brown, and gray lesions may be present. When active HS lesions subside, intense hyperpigmentation may be left behind, and in some skin tones a pink or violaceous lesion may be apparent.

Worth noting

HS is disfiguring and has a negative impact on quality of life, including social relationships. Mental health support and screening tools are useful. Pain also is a common concern and may warrant referral to a pain specialist.⁶ In early disease, HS lesions can be misdiagnosed as an infection that recurs in the same location.

Treatments for HS include oral antibiotics (ie, tetracyclines, rifampin, clindamycin), topical antibiotics, immunosuppressing biologics, metformin, and spironolactone.⁷ Surgical interventions may be considered earlier in HS management and vary based on the location and severity of the lesions.⁸

Patients with HS are at risk for developing squamous cell carcinoma in scars, even many years later⁹; therefore, patients should perform skin checks and be referred to a dermatologist. Squamous cell carcinoma is most commonly found on the buttocks of men with HS and has a poor prognosis.

Health disparity highlight

Although those of African American and African descent have the highest rates of HS,¹ the clinical trials for adalimumab (the only biologic approved for HS) enrolled a low number of Black patients.

Thirty HS comorbidities have been identified. Garg et al¹⁰ recommended that dermatologists perform examinations for comorbid conditions involving the skin and conduct a simple review of systems for extracutaneous comorbidities. Access to medical care is essential, and health care system barriers affect the ability of some patients to receive adequate continuity of care.

The diagnosis of HS often is delayed due to a lack of knowledge about the condition in the medical community at large and delayed presentation to a dermatologist.

MILAN – The day after deucravacitinib became the first TYK2 inhibitor approved for the treatment of moderate to severe psoriasis, long-term data were presented at the annual congress of the European Academy of Dermatology and Venereology, suggesting that a high degree of benefit persists for at least 2 years, making this oral drug a potential competitor for biologics.

As a once-daily drug, deucravacitinib has “the potential to be a treatment of choice and a new standard of care for patients who require systemic therapy for their moderate to severe plaque psoriasis,” said Mark G. Lebwohl, MD, professor of dermatology and dean of clinical therapeutics, Icahn School of Medicine at Mount Sinai, New York.

Just 2 months after the 52-week data from the phase 3 POETYK PSO-1 trial were published online in the Journal of the American Academy of Dermatology, a long-term extension study found essentially no loss of benefit at 112 weeks, according to Dr. Lebwohl.

One of the two co-primary endpoints was a 75% clearance on the Psoriasis and Severity Index (PASI75) score. At 52 weeks, 80.2% of patients on deucravacitinib had met this criterion of benefit. At 112 weeks, the proportion was 84.4%.

The other primary endpoint was a static Physician’s Global Assessment (sPGA) score of clear or almost clear skin. The proportion of patients meeting this criterion at weeks 52 and 112 weeks were 65.6% and 67.6%, respectively.

When assessed by Treatment Failure Rule (TFR) or modified nonresponder imputation (mNRI), results were similar. For both, the primary endpoints at every time interval were just one or two percentage points lower but not clinically meaningfully different, according to Dr. Lebwohl.

The same type of sustained response out to 112 weeks was observed in multiple analyses. When the researchers isolated the subgroup of patients who had achieved a PASI 75 response at 16 weeks (100%), there was a modest decline in the PASI 75 rate at week 52 (90.2%) but then no additional decline at week 112 (91.3%).

There were essentially no changes in the PASI 90 rates at week 16 (63%), week 52 (65.3%), and week 112 (63.1%), Dr. Lebwohl reported. PASI 100 rates, once achieved, were sustained long term.

The target, TYK2, is one of four Janus kinase (JAK) inhibitors. Until now, almost all JAK inhibitors have had greater relative specificity for JAK 1, JAK 2, and JAK 3, but several inhibitors of TYK2 inhibitors other than deucravacitinib are in development for inflammatory diseases. Deucravacitinib (Sotyktu), approved by the Food and Drug Administration on Sept. 9, is the only TYK2 inhibitor with regulatory approval for plaque psoriasis.

In the POETYK PSO-1 trial, 666 patients were initially randomized in a 2:1:1 ratio to 6 mg deucravacitinib (now the approved dose), placebo, or the oral phosphodiesterase 4 inhibitor apremilast. At week 16, patients on placebo were switched over to deucravacitinib. At week 24, patients who did not achieve a PASI 50 on apremilast (which had been titrated to 10 mg daily to 30 mg twice a day over the first 5 days of dosing) were switched to deucravacitinib.

In the previously reported data, deucravacitinib was superior for all efficacy endpoints at week 16, including an analysis of quality of life when compared with placebo (P < .0001) or apremilast (P = .0088). At week 52, after having been switched to deucravacitinib at week 16, patients on placebo achieved comparable responses on the efficacy measures in this study, including PASI75.

Relative to JAK inhibitors commonly used in rheumatoid arthritis and other inflammatory diseases, the greater specificity of deucravacitinib for TYK2 appears to have meaningful safety advantages, according to Dr. Lebwohl. Targeted mostly on the TYK2 regulatory domain, deucravacitinib largely avoids inhibition of the JAK 1, 2, and 3 subtypes. Dr. Lebwohl said this explains why deucravacitinib labeling does not share the boxed warnings about off-target effects, such as those on the cardiovascular system, that can be found in the labeling of other JAK inhibitors.

In the published 52-week data, the discontinuation rate for adverse events was lower in the group randomized to deucravacitinib arm than in the placebo arm. In the extended follow-up, there were no new signals for adverse events, including those involving the CV system or immune function.

The key message so far from the long-term follow-up, which is ongoing, is that “continuous treatment with deucravacitinib is associated with durable efficacy,” Dr. Lebwohl said. It is this combination of sustained efficacy and safety that led Dr. Lebwohl to suggest it as a reasonable oral competitor to injectable biologics.

“Patients now have a choice,” he said.

Jashin J. Wu, MD, a board member of the National Psoriasis Foundation and an associate professor in the department of dermatology, University of Miami, has been following the development of deucravacitinib. He said that the recent FDA approval validates the clinical evidence of benefit and safety, while the long-term data presented at the EADV congress support its role in expanding treatment options.

“Deucravacitinib is a very effective oral agent for moderate to severe plaque psoriasis with strong maintenance of effect through week 112,” he said. Differentiating it from other JAK inhibitors, the FDA approval “confirms the safety of this agent as there is no boxed warning,” he added.

Dr. Lebwohl reports financial relationships with more than 30 pharmaceutical companies, including Bristol-Myers Squibb, the manufacturer of deucravacitinib. Dr. Wu has financial relationships with 14 pharmaceutical companies, including Bristol-Myers Squibb, but he was not an investigator for the phase 3 trials of deucravacitinib.

MILAN – The day after deucravacitinib became the first TYK2 inhibitor approved for the treatment of moderate to severe psoriasis, long-term data were presented at the annual congress of the European Academy of Dermatology and Venereology, suggesting that a high degree of benefit persists for at least 2 years, making this oral drug a potential competitor for biologics.

As a once-daily drug, deucravacitinib has “the potential to be a treatment of choice and a new standard of care for patients who require systemic therapy for their moderate to severe plaque psoriasis,” said Mark G. Lebwohl, MD, professor of dermatology and dean of clinical therapeutics, Icahn School of Medicine at Mount Sinai, New York.

Just 2 months after the 52-week data from the phase 3 POETYK PSO-1 trial were published online in the Journal of the American Academy of Dermatology, a long-term extension study found essentially no loss of benefit at 112 weeks, according to Dr. Lebwohl.

One of the two co-primary endpoints was a 75% clearance on the Psoriasis and Severity Index (PASI75) score. At 52 weeks, 80.2% of patients on deucravacitinib had met this criterion of benefit. At 112 weeks, the proportion was 84.4%.

The other primary endpoint was a static Physician’s Global Assessment (sPGA) score of clear or almost clear skin. The proportion of patients meeting this criterion at weeks 52 and 112 weeks were 65.6% and 67.6%, respectively.

When assessed by Treatment Failure Rule (TFR) or modified nonresponder imputation (mNRI), results were similar. For both, the primary endpoints at every time interval were just one or two percentage points lower but not clinically meaningfully different, according to Dr. Lebwohl.

The same type of sustained response out to 112 weeks was observed in multiple analyses. When the researchers isolated the subgroup of patients who had achieved a PASI 75 response at 16 weeks (100%), there was a modest decline in the PASI 75 rate at week 52 (90.2%) but then no additional decline at week 112 (91.3%).

There were essentially no changes in the PASI 90 rates at week 16 (63%), week 52 (65.3%), and week 112 (63.1%), Dr. Lebwohl reported. PASI 100 rates, once achieved, were sustained long term.

The target, TYK2, is one of four Janus kinase (JAK) inhibitors. Until now, almost all JAK inhibitors have had greater relative specificity for JAK 1, JAK 2, and JAK 3, but several inhibitors of TYK2 inhibitors other than deucravacitinib are in development for inflammatory diseases. Deucravacitinib (Sotyktu), approved by the Food and Drug Administration on Sept. 9, is the only TYK2 inhibitor with regulatory approval for plaque psoriasis.

In the POETYK PSO-1 trial, 666 patients were initially randomized in a 2:1:1 ratio to 6 mg deucravacitinib (now the approved dose), placebo, or the oral phosphodiesterase 4 inhibitor apremilast. At week 16, patients on placebo were switched over to deucravacitinib. At week 24, patients who did not achieve a PASI 50 on apremilast (which had been titrated to 10 mg daily to 30 mg twice a day over the first 5 days of dosing) were switched to deucravacitinib.

In the previously reported data, deucravacitinib was superior for all efficacy endpoints at week 16, including an analysis of quality of life when compared with placebo (P < .0001) or apremilast (P = .0088). At week 52, after having been switched to deucravacitinib at week 16, patients on placebo achieved comparable responses on the efficacy measures in this study, including PASI75.

Relative to JAK inhibitors commonly used in rheumatoid arthritis and other inflammatory diseases, the greater specificity of deucravacitinib for TYK2 appears to have meaningful safety advantages, according to Dr. Lebwohl. Targeted mostly on the TYK2 regulatory domain, deucravacitinib largely avoids inhibition of the JAK 1, 2, and 3 subtypes. Dr. Lebwohl said this explains why deucravacitinib labeling does not share the boxed warnings about off-target effects, such as those on the cardiovascular system, that can be found in the labeling of other JAK inhibitors.

In the published 52-week data, the discontinuation rate for adverse events was lower in the group randomized to deucravacitinib arm than in the placebo arm. In the extended follow-up, there were no new signals for adverse events, including those involving the CV system or immune function.

The key message so far from the long-term follow-up, which is ongoing, is that “continuous treatment with deucravacitinib is associated with durable efficacy,” Dr. Lebwohl said. It is this combination of sustained efficacy and safety that led Dr. Lebwohl to suggest it as a reasonable oral competitor to injectable biologics.

“Patients now have a choice,” he said.

Jashin J. Wu, MD, a board member of the National Psoriasis Foundation and an associate professor in the department of dermatology, University of Miami, has been following the development of deucravacitinib. He said that the recent FDA approval validates the clinical evidence of benefit and safety, while the long-term data presented at the EADV congress support its role in expanding treatment options.

“Deucravacitinib is a very effective oral agent for moderate to severe plaque psoriasis with strong maintenance of effect through week 112,” he said. Differentiating it from other JAK inhibitors, the FDA approval “confirms the safety of this agent as there is no boxed warning,” he added.

Dr. Lebwohl reports financial relationships with more than 30 pharmaceutical companies, including Bristol-Myers Squibb, the manufacturer of deucravacitinib. Dr. Wu has financial relationships with 14 pharmaceutical companies, including Bristol-Myers Squibb, but he was not an investigator for the phase 3 trials of deucravacitinib.

MILAN – The day after deucravacitinib became the first TYK2 inhibitor approved for the treatment of moderate to severe psoriasis, long-term data were presented at the annual congress of the European Academy of Dermatology and Venereology, suggesting that a high degree of benefit persists for at least 2 years, making this oral drug a potential competitor for biologics.

As a once-daily drug, deucravacitinib has “the potential to be a treatment of choice and a new standard of care for patients who require systemic therapy for their moderate to severe plaque psoriasis,” said Mark G. Lebwohl, MD, professor of dermatology and dean of clinical therapeutics, Icahn School of Medicine at Mount Sinai, New York.

Just 2 months after the 52-week data from the phase 3 POETYK PSO-1 trial were published online in the Journal of the American Academy of Dermatology, a long-term extension study found essentially no loss of benefit at 112 weeks, according to Dr. Lebwohl.

One of the two co-primary endpoints was a 75% clearance on the Psoriasis and Severity Index (PASI75) score. At 52 weeks, 80.2% of patients on deucravacitinib had met this criterion of benefit. At 112 weeks, the proportion was 84.4%.

The other primary endpoint was a static Physician’s Global Assessment (sPGA) score of clear or almost clear skin. The proportion of patients meeting this criterion at weeks 52 and 112 weeks were 65.6% and 67.6%, respectively.

When assessed by Treatment Failure Rule (TFR) or modified nonresponder imputation (mNRI), results were similar. For both, the primary endpoints at every time interval were just one or two percentage points lower but not clinically meaningfully different, according to Dr. Lebwohl.

The same type of sustained response out to 112 weeks was observed in multiple analyses. When the researchers isolated the subgroup of patients who had achieved a PASI 75 response at 16 weeks (100%), there was a modest decline in the PASI 75 rate at week 52 (90.2%) but then no additional decline at week 112 (91.3%).

There were essentially no changes in the PASI 90 rates at week 16 (63%), week 52 (65.3%), and week 112 (63.1%), Dr. Lebwohl reported. PASI 100 rates, once achieved, were sustained long term.

The target, TYK2, is one of four Janus kinase (JAK) inhibitors. Until now, almost all JAK inhibitors have had greater relative specificity for JAK 1, JAK 2, and JAK 3, but several inhibitors of TYK2 inhibitors other than deucravacitinib are in development for inflammatory diseases. Deucravacitinib (Sotyktu), approved by the Food and Drug Administration on Sept. 9, is the only TYK2 inhibitor with regulatory approval for plaque psoriasis.

In the POETYK PSO-1 trial, 666 patients were initially randomized in a 2:1:1 ratio to 6 mg deucravacitinib (now the approved dose), placebo, or the oral phosphodiesterase 4 inhibitor apremilast. At week 16, patients on placebo were switched over to deucravacitinib. At week 24, patients who did not achieve a PASI 50 on apremilast (which had been titrated to 10 mg daily to 30 mg twice a day over the first 5 days of dosing) were switched to deucravacitinib.

In the previously reported data, deucravacitinib was superior for all efficacy endpoints at week 16, including an analysis of quality of life when compared with placebo (P < .0001) or apremilast (P = .0088). At week 52, after having been switched to deucravacitinib at week 16, patients on placebo achieved comparable responses on the efficacy measures in this study, including PASI75.

Relative to JAK inhibitors commonly used in rheumatoid arthritis and other inflammatory diseases, the greater specificity of deucravacitinib for TYK2 appears to have meaningful safety advantages, according to Dr. Lebwohl. Targeted mostly on the TYK2 regulatory domain, deucravacitinib largely avoids inhibition of the JAK 1, 2, and 3 subtypes. Dr. Lebwohl said this explains why deucravacitinib labeling does not share the boxed warnings about off-target effects, such as those on the cardiovascular system, that can be found in the labeling of other JAK inhibitors.

In the published 52-week data, the discontinuation rate for adverse events was lower in the group randomized to deucravacitinib arm than in the placebo arm. In the extended follow-up, there were no new signals for adverse events, including those involving the CV system or immune function.

The key message so far from the long-term follow-up, which is ongoing, is that “continuous treatment with deucravacitinib is associated with durable efficacy,” Dr. Lebwohl said. It is this combination of sustained efficacy and safety that led Dr. Lebwohl to suggest it as a reasonable oral competitor to injectable biologics.

“Patients now have a choice,” he said.

Jashin J. Wu, MD, a board member of the National Psoriasis Foundation and an associate professor in the department of dermatology, University of Miami, has been following the development of deucravacitinib. He said that the recent FDA approval validates the clinical evidence of benefit and safety, while the long-term data presented at the EADV congress support its role in expanding treatment options.

“Deucravacitinib is a very effective oral agent for moderate to severe plaque psoriasis with strong maintenance of effect through week 112,” he said. Differentiating it from other JAK inhibitors, the FDA approval “confirms the safety of this agent as there is no boxed warning,” he added.

Dr. Lebwohl reports financial relationships with more than 30 pharmaceutical companies, including Bristol-Myers Squibb, the manufacturer of deucravacitinib. Dr. Wu has financial relationships with 14 pharmaceutical companies, including Bristol-Myers Squibb, but he was not an investigator for the phase 3 trials of deucravacitinib.

MILAN – The therapeutic value of inhibiting the activity of IgE in patients with chronic spontaneous urticaria (CSU) was reinforced by two large phase 3 trials with ligelizumab, a drug characterized as a new generation anti-IgE monoclonal antibody.

Both doses of ligelizumab evaluated met the primary endpoint of superiority to placebo for a complete response at 16 weeks of therapy, reported Marcus Maurer, MD, director of the Urticaria Center for Reference and Excellence at the Charité Hospital, Berlin.

The data from the two identically designed trials, PEARL 1 and PEARL 2, were presented at the annual congress of the European Academy of Dermatology and Venereology. The two ligelizumab experimental arms (72 mg or 120 mg administered subcutaneously every 4 weeks) and the active comparative arm of omalizumab (300 mg administered subcutaneously every 4 weeks) demonstrated similar efficacy, all three of which were highly superior to placebo.

The data show that “another anti-IgE therapy – ligelizumab – is effective in CSU,” Dr. Maurer said.

“While the benefit was not different from omalizumab, ligelizumab showed remarkable results in disease activity and by demonstrating just how many patients achieved what we want them to achieve, which is to have no more signs and symptoms,” he added.
 

Majority of participants with severe urticaria

All of the patients entered into the two trials had severe (about 65%) or moderate (about 35%) symptoms at baseline. The results of the two trials were almost identical. In the randomization arms, a weekly Urticaria Activity Score (UAS7) of 0, which was the primary endpoint, was achieved at week 16 by 31.0% of those receiving 72-mg ligelizumab, 38.3% of those receiving 120-mg ligelizumab, and 34.1% of those receiving omalizumab (Xolair). The placebo response was 5.7%.

The UAS7 score is drawn from two components, wheals and itch. The range is 0 (no symptoms) to 42 (most severe). At baseline, the average patients’ scores were about 30, which correlates with a substantial symptom burden, according to Dr. Maurer.

The mean reduction in the UAS7 score in PEARL 2, which differed from PEARL 1 by no more than 0.4 points for any treatment group, was 19.2 points in the 72-mg ligelizumab group, 19.3 points in the 120-mg ligelizumab group, 19.6 points in the omalizumab group, and 9.2 points in the placebo group. There were no significant differences between any active treatment arm.

Complete symptom relief, meaning a UAS7 score of 0, was selected as the primary endpoint, because Dr. Maurer said that this is the goal of treatment. Although he admitted that a UAS7 score of 0 is analogous to a PASI score in psoriasis of 100 (complete clearing), he said, “Chronic urticaria is a debilitating disease, and we want to eliminate the symptoms. Gone is gone.”

Combined, the two phase 3 trials represent “the biggest chronic urticaria program ever,” according to Dr. Maurer. The 1,034 patients enrolled in PEARL 1 and the 1,023 enrolled in PEARL 2 were randomized in a 3:3:3:1 ratio with placebo representing the smaller group.

The planned follow-up is 52 weeks, but the placebo group will be switched to 120 mg ligelizumab every 4 weeks at the end of 24 weeks. The switch is required because “you cannot maintain patients with this disease on placebo over a long period,” Dr. Maurer said.
 

Ligelizumab associated with low discontinuation rate

Adverse events overall and stratified by severity have been similar across treatment arms, including placebo. The possible exception was a lower rate of moderate events (16.5%) in the placebo arm relative to the 72-mg ligelizumab arm (19.8%), the 120-mg ligelizumab arm (21.6%), and the omalizumab arm (22.3%). Discontinuations because of an adverse event were under 4% in every treatment arm.

Although Dr. Maurer did not present outcomes at 52 weeks, he did note that “only 15% of those who enrolled in these trials have discontinued treatment.” He considered this remarkable in that the study was conducted in the midst of the COVID-19 pandemic, and it appears that at least some of those left the trial did so because of concern for clinic visits.

Despite the similar benefit provided by ligelizumab and omalizumab, Dr. Maurer said that subgroup analyses will be coming. The possibility that some patients benefit more from one than the another cannot yet be ruled out. There are also, as of yet, no data to determine whether at least some patients respond to one after an inadequate response to the other.

Still, given the efficacy and the safety of ligelizumab, Dr. Maurer indicated that the drug is likely to find a role in routine management of CSU if approved.

“We only have two options for chronic spontaneous urticaria. There are antihistamines, which do not usually work, and omalizumab,” he said. “It is very important we develop more treatment options.”

Adam Friedman, MD, professor and chair of dermatology, George Washington University, Washington, agreed.

“More therapeutic options, especially for disease states that have a small armament – even if equivalent in efficacy to established therapies – is always a win for patients as it almost always increases access to treatment,” Dr. Friedman said in an interview.

“Furthermore, the heterogeneous nature of inflammatory skin diseases is often not captured in even phase 3 studies. Therefore, having additional options could offer relief where previous therapies have failed,” he added.

Dr. Maurer reports financial relationships with more than 10 pharmaceutical companies, including Novartis, which is developing ligelizumab. Dr. Friedman has a financial relationship with more than 20 pharmaceutical companies but has no current financial association with Novartis and was not involved in the PEARL 1 and 2 trials.

MILAN – The therapeutic value of inhibiting the activity of IgE in patients with chronic spontaneous urticaria (CSU) was reinforced by two large phase 3 trials with ligelizumab, a drug characterized as a new generation anti-IgE monoclonal antibody.

Both doses of ligelizumab evaluated met the primary endpoint of superiority to placebo for a complete response at 16 weeks of therapy, reported Marcus Maurer, MD, director of the Urticaria Center for Reference and Excellence at the Charité Hospital, Berlin.

The data from the two identically designed trials, PEARL 1 and PEARL 2, were presented at the annual congress of the European Academy of Dermatology and Venereology. The two ligelizumab experimental arms (72 mg or 120 mg administered subcutaneously every 4 weeks) and the active comparative arm of omalizumab (300 mg administered subcutaneously every 4 weeks) demonstrated similar efficacy, all three of which were highly superior to placebo.

The data show that “another anti-IgE therapy – ligelizumab – is effective in CSU,” Dr. Maurer said.

“While the benefit was not different from omalizumab, ligelizumab showed remarkable results in disease activity and by demonstrating just how many patients achieved what we want them to achieve, which is to have no more signs and symptoms,” he added.
 

Majority of participants with severe urticaria

All of the patients entered into the two trials had severe (about 65%) or moderate (about 35%) symptoms at baseline. The results of the two trials were almost identical. In the randomization arms, a weekly Urticaria Activity Score (UAS7) of 0, which was the primary endpoint, was achieved at week 16 by 31.0% of those receiving 72-mg ligelizumab, 38.3% of those receiving 120-mg ligelizumab, and 34.1% of those receiving omalizumab (Xolair). The placebo response was 5.7%.

The UAS7 score is drawn from two components, wheals and itch. The range is 0 (no symptoms) to 42 (most severe). At baseline, the average patients’ scores were about 30, which correlates with a substantial symptom burden, according to Dr. Maurer.

The mean reduction in the UAS7 score in PEARL 2, which differed from PEARL 1 by no more than 0.4 points for any treatment group, was 19.2 points in the 72-mg ligelizumab group, 19.3 points in the 120-mg ligelizumab group, 19.6 points in the omalizumab group, and 9.2 points in the placebo group. There were no significant differences between any active treatment arm.

Complete symptom relief, meaning a UAS7 score of 0, was selected as the primary endpoint, because Dr. Maurer said that this is the goal of treatment. Although he admitted that a UAS7 score of 0 is analogous to a PASI score in psoriasis of 100 (complete clearing), he said, “Chronic urticaria is a debilitating disease, and we want to eliminate the symptoms. Gone is gone.”

Combined, the two phase 3 trials represent “the biggest chronic urticaria program ever,” according to Dr. Maurer. The 1,034 patients enrolled in PEARL 1 and the 1,023 enrolled in PEARL 2 were randomized in a 3:3:3:1 ratio with placebo representing the smaller group.

The planned follow-up is 52 weeks, but the placebo group will be switched to 120 mg ligelizumab every 4 weeks at the end of 24 weeks. The switch is required because “you cannot maintain patients with this disease on placebo over a long period,” Dr. Maurer said.
 

Ligelizumab associated with low discontinuation rate

Adverse events overall and stratified by severity have been similar across treatment arms, including placebo. The possible exception was a lower rate of moderate events (16.5%) in the placebo arm relative to the 72-mg ligelizumab arm (19.8%), the 120-mg ligelizumab arm (21.6%), and the omalizumab arm (22.3%). Discontinuations because of an adverse event were under 4% in every treatment arm.

Although Dr. Maurer did not present outcomes at 52 weeks, he did note that “only 15% of those who enrolled in these trials have discontinued treatment.” He considered this remarkable in that the study was conducted in the midst of the COVID-19 pandemic, and it appears that at least some of those left the trial did so because of concern for clinic visits.

Despite the similar benefit provided by ligelizumab and omalizumab, Dr. Maurer said that subgroup analyses will be coming. The possibility that some patients benefit more from one than the another cannot yet be ruled out. There are also, as of yet, no data to determine whether at least some patients respond to one after an inadequate response to the other.

Still, given the efficacy and the safety of ligelizumab, Dr. Maurer indicated that the drug is likely to find a role in routine management of CSU if approved.

“We only have two options for chronic spontaneous urticaria. There are antihistamines, which do not usually work, and omalizumab,” he said. “It is very important we develop more treatment options.”

Adam Friedman, MD, professor and chair of dermatology, George Washington University, Washington, agreed.

“More therapeutic options, especially for disease states that have a small armament – even if equivalent in efficacy to established therapies – is always a win for patients as it almost always increases access to treatment,” Dr. Friedman said in an interview.

“Furthermore, the heterogeneous nature of inflammatory skin diseases is often not captured in even phase 3 studies. Therefore, having additional options could offer relief where previous therapies have failed,” he added.

Dr. Maurer reports financial relationships with more than 10 pharmaceutical companies, including Novartis, which is developing ligelizumab. Dr. Friedman has a financial relationship with more than 20 pharmaceutical companies but has no current financial association with Novartis and was not involved in the PEARL 1 and 2 trials.

MILAN – The therapeutic value of inhibiting the activity of IgE in patients with chronic spontaneous urticaria (CSU) was reinforced by two large phase 3 trials with ligelizumab, a drug characterized as a new generation anti-IgE monoclonal antibody.

Both doses of ligelizumab evaluated met the primary endpoint of superiority to placebo for a complete response at 16 weeks of therapy, reported Marcus Maurer, MD, director of the Urticaria Center for Reference and Excellence at the Charité Hospital, Berlin.

The data from the two identically designed trials, PEARL 1 and PEARL 2, were presented at the annual congress of the European Academy of Dermatology and Venereology. The two ligelizumab experimental arms (72 mg or 120 mg administered subcutaneously every 4 weeks) and the active comparative arm of omalizumab (300 mg administered subcutaneously every 4 weeks) demonstrated similar efficacy, all three of which were highly superior to placebo.

The data show that “another anti-IgE therapy – ligelizumab – is effective in CSU,” Dr. Maurer said.

“While the benefit was not different from omalizumab, ligelizumab showed remarkable results in disease activity and by demonstrating just how many patients achieved what we want them to achieve, which is to have no more signs and symptoms,” he added.
 

Majority of participants with severe urticaria

All of the patients entered into the two trials had severe (about 65%) or moderate (about 35%) symptoms at baseline. The results of the two trials were almost identical. In the randomization arms, a weekly Urticaria Activity Score (UAS7) of 0, which was the primary endpoint, was achieved at week 16 by 31.0% of those receiving 72-mg ligelizumab, 38.3% of those receiving 120-mg ligelizumab, and 34.1% of those receiving omalizumab (Xolair). The placebo response was 5.7%.

The UAS7 score is drawn from two components, wheals and itch. The range is 0 (no symptoms) to 42 (most severe). At baseline, the average patients’ scores were about 30, which correlates with a substantial symptom burden, according to Dr. Maurer.

The mean reduction in the UAS7 score in PEARL 2, which differed from PEARL 1 by no more than 0.4 points for any treatment group, was 19.2 points in the 72-mg ligelizumab group, 19.3 points in the 120-mg ligelizumab group, 19.6 points in the omalizumab group, and 9.2 points in the placebo group. There were no significant differences between any active treatment arm.

Complete symptom relief, meaning a UAS7 score of 0, was selected as the primary endpoint, because Dr. Maurer said that this is the goal of treatment. Although he admitted that a UAS7 score of 0 is analogous to a PASI score in psoriasis of 100 (complete clearing), he said, “Chronic urticaria is a debilitating disease, and we want to eliminate the symptoms. Gone is gone.”

Combined, the two phase 3 trials represent “the biggest chronic urticaria program ever,” according to Dr. Maurer. The 1,034 patients enrolled in PEARL 1 and the 1,023 enrolled in PEARL 2 were randomized in a 3:3:3:1 ratio with placebo representing the smaller group.

The planned follow-up is 52 weeks, but the placebo group will be switched to 120 mg ligelizumab every 4 weeks at the end of 24 weeks. The switch is required because “you cannot maintain patients with this disease on placebo over a long period,” Dr. Maurer said.
 

Ligelizumab associated with low discontinuation rate

Adverse events overall and stratified by severity have been similar across treatment arms, including placebo. The possible exception was a lower rate of moderate events (16.5%) in the placebo arm relative to the 72-mg ligelizumab arm (19.8%), the 120-mg ligelizumab arm (21.6%), and the omalizumab arm (22.3%). Discontinuations because of an adverse event were under 4% in every treatment arm.

Although Dr. Maurer did not present outcomes at 52 weeks, he did note that “only 15% of those who enrolled in these trials have discontinued treatment.” He considered this remarkable in that the study was conducted in the midst of the COVID-19 pandemic, and it appears that at least some of those left the trial did so because of concern for clinic visits.

Despite the similar benefit provided by ligelizumab and omalizumab, Dr. Maurer said that subgroup analyses will be coming. The possibility that some patients benefit more from one than the another cannot yet be ruled out. There are also, as of yet, no data to determine whether at least some patients respond to one after an inadequate response to the other.

Still, given the efficacy and the safety of ligelizumab, Dr. Maurer indicated that the drug is likely to find a role in routine management of CSU if approved.

“We only have two options for chronic spontaneous urticaria. There are antihistamines, which do not usually work, and omalizumab,” he said. “It is very important we develop more treatment options.”

Adam Friedman, MD, professor and chair of dermatology, George Washington University, Washington, agreed.

“More therapeutic options, especially for disease states that have a small armament – even if equivalent in efficacy to established therapies – is always a win for patients as it almost always increases access to treatment,” Dr. Friedman said in an interview.

“Furthermore, the heterogeneous nature of inflammatory skin diseases is often not captured in even phase 3 studies. Therefore, having additional options could offer relief where previous therapies have failed,” he added.

Dr. Maurer reports financial relationships with more than 10 pharmaceutical companies, including Novartis, which is developing ligelizumab. Dr. Friedman has a financial relationship with more than 20 pharmaceutical companies but has no current financial association with Novartis and was not involved in the PEARL 1 and 2 trials.

The Food and Drug Administration has issued a safety alert, warning of a rare but concerning potential risk of squamous cell carcinoma (SCC) and various lymphomas in the scar tissue around breast implants.

The FDA safety communication is based on several dozen reports of these cancers occurring in the capsule or scar tissue around breast implants. This issue differs from breast implant–associated anaplastic large-cell lymphoma (BIA-ALCL) – a known risk among implant recipients.

“After preliminary review of published literature as part of our ongoing monitoring of the safety of breast implants, the FDA is aware of less than 20 cases of SCC and less than 30 cases of various lymphomas in the capsule around the breast implant,” the agency’s alert explains.

One avenue through which the FDA has identified cases is via medical device reports. As of Sept. 1, the FDA has received 10 medical device reports about SCC related to breast implants and 12 about various lymphomas.

The incidence rate and risk factors for these events are currently unknown, but reports of SCC and various lymphomas in the capsule around the breast implants have been reported for both textured and smooth breast implants, as well as for both saline and silicone breast implants. In some cases, the cancers were diagnosed years after breast implant surgery.

Reported signs and symptoms included swelling, pain, lumps, or skin changes. 

Although the risks of SCC and lymphomas in the tissue around breast implants appears rare, “when safety risks with medical devices are identified, we wanted to provide clear and understandable information to the public as quickly as possible,” Binita Ashar, MD, director of the Office of Surgical and Infection Control Devices, FDA Center for Devices and Radiological Health, explained in a press release.

Patients and providers are strongly encouraged to report breast implant–related problems and cases of SCC or lymphoma of the breast implant capsule to MedWatch, the FDA’s adverse event reporting program.

The FDA plans to complete “a thorough literature review” as well as “identify ways to collect more detailed information regarding patient cases.”

A version of this article first appeared on Medscape.com.

The Food and Drug Administration has issued a safety alert, warning of a rare but concerning potential risk of squamous cell carcinoma (SCC) and various lymphomas in the scar tissue around breast implants.

The FDA safety communication is based on several dozen reports of these cancers occurring in the capsule or scar tissue around breast implants. This issue differs from breast implant–associated anaplastic large-cell lymphoma (BIA-ALCL) – a known risk among implant recipients.

“After preliminary review of published literature as part of our ongoing monitoring of the safety of breast implants, the FDA is aware of less than 20 cases of SCC and less than 30 cases of various lymphomas in the capsule around the breast implant,” the agency’s alert explains.

One avenue through which the FDA has identified cases is via medical device reports. As of Sept. 1, the FDA has received 10 medical device reports about SCC related to breast implants and 12 about various lymphomas.

The incidence rate and risk factors for these events are currently unknown, but reports of SCC and various lymphomas in the capsule around the breast implants have been reported for both textured and smooth breast implants, as well as for both saline and silicone breast implants. In some cases, the cancers were diagnosed years after breast implant surgery.

Reported signs and symptoms included swelling, pain, lumps, or skin changes. 

Although the risks of SCC and lymphomas in the tissue around breast implants appears rare, “when safety risks with medical devices are identified, we wanted to provide clear and understandable information to the public as quickly as possible,” Binita Ashar, MD, director of the Office of Surgical and Infection Control Devices, FDA Center for Devices and Radiological Health, explained in a press release.

Patients and providers are strongly encouraged to report breast implant–related problems and cases of SCC or lymphoma of the breast implant capsule to MedWatch, the FDA’s adverse event reporting program.

The FDA plans to complete “a thorough literature review” as well as “identify ways to collect more detailed information regarding patient cases.”

A version of this article first appeared on Medscape.com.

The Food and Drug Administration has issued a safety alert, warning of a rare but concerning potential risk of squamous cell carcinoma (SCC) and various lymphomas in the scar tissue around breast implants.

The FDA safety communication is based on several dozen reports of these cancers occurring in the capsule or scar tissue around breast implants. This issue differs from breast implant–associated anaplastic large-cell lymphoma (BIA-ALCL) – a known risk among implant recipients.

“After preliminary review of published literature as part of our ongoing monitoring of the safety of breast implants, the FDA is aware of less than 20 cases of SCC and less than 30 cases of various lymphomas in the capsule around the breast implant,” the agency’s alert explains.

One avenue through which the FDA has identified cases is via medical device reports. As of Sept. 1, the FDA has received 10 medical device reports about SCC related to breast implants and 12 about various lymphomas.

The incidence rate and risk factors for these events are currently unknown, but reports of SCC and various lymphomas in the capsule around the breast implants have been reported for both textured and smooth breast implants, as well as for both saline and silicone breast implants. In some cases, the cancers were diagnosed years after breast implant surgery.

Reported signs and symptoms included swelling, pain, lumps, or skin changes. 

Although the risks of SCC and lymphomas in the tissue around breast implants appears rare, “when safety risks with medical devices are identified, we wanted to provide clear and understandable information to the public as quickly as possible,” Binita Ashar, MD, director of the Office of Surgical and Infection Control Devices, FDA Center for Devices and Radiological Health, explained in a press release.

Patients and providers are strongly encouraged to report breast implant–related problems and cases of SCC or lymphoma of the breast implant capsule to MedWatch, the FDA’s adverse event reporting program.

The FDA plans to complete “a thorough literature review” as well as “identify ways to collect more detailed information regarding patient cases.”

A version of this article first appeared on Medscape.com.

This patient was given a diagnosis of confluent and reticulated papillomatosis (CRP) based on the clinical presentation.

CRP is characterized by centrally confluent and peripherally reticulated scaly brown plaques and papules that are cosmetically disfiguring.¹ CRP is usually asymptomatic and primarily impacts young adults—especially teenagers.^2,3 It affects both males and females and commonly occurs on the trunk.^1-3 CRP is believed to be a disorder of keratinization. Malassezia furfur may induce CRP’s hyperproliferative epidermal changes, but systemic treatment that eliminates this organism does not clear CRP.³

A CRP diagnosis is made based on clinical presentation. The eruption usually begins as verrucous papules in the inframammary or epigastric region that enlarge to 4 to 5 mm in diameter and coalesce to form a confluent plaque with a peripheral reticulated pattern. CRP can extend over the back, chest, and abdomen to the neck, shoulders, and gluteal cleft. CRP does not affect the oral mucosa, and rarely involves flexural areas, which differentiates it from the similar looking acanthosis nigricans.² Although most cases are asymptomatic, mild pruritus may occur.^1,2

A skin biopsy is rarely necessary for making a CRP diagnosis, but histopathologic findings include papillomatosis, hyperkeratosis, variable acanthosis, follicular plugging, and sparse dermal inflammation.^1,3

Systemic antibiotics, most commonly minocycline 100 mg bid for 30 days or doxycycline 100 mg bid for 30 days, are safe and effective for CRP.^1,4 Sometimes treatment is extended for as long as 6 months. Although CRP usually responds to minocycline or doxycycline, it is believed that this is the result of these drugs’ anti-inflammatory—rather than antibiotic—properties.^1,2,4 Azithromycin is an effective alternative therapy.^2,4 There is a high rate of recurrence of CRP in patients after systemic antibiotics are discontinued.² Uniform responses to treatment and retreatment of flares have solidified the belief that antibiotics are an effective suppressive (if not curative) therapy despite a lack of randomized controlled trials.⁴

This patient was treated with minocycline 100 mg bid. After 1 month, the rash had improved by 70%. At 3 months, it was completely clear, and treatment was discontinued.

‌

This case was adapted from: Sessums MT, Ward KMH, Brodell R. Cutaneous eruption on chest and back. J Fam Pract. 2014;63:467-468.

This patient was given a diagnosis of confluent and reticulated papillomatosis (CRP) based on the clinical presentation.

CRP is characterized by centrally confluent and peripherally reticulated scaly brown plaques and papules that are cosmetically disfiguring.¹ CRP is usually asymptomatic and primarily impacts young adults—especially teenagers.^2,3 It affects both males and females and commonly occurs on the trunk.^1-3 CRP is believed to be a disorder of keratinization. Malassezia furfur may induce CRP’s hyperproliferative epidermal changes, but systemic treatment that eliminates this organism does not clear CRP.³

A CRP diagnosis is made based on clinical presentation. The eruption usually begins as verrucous papules in the inframammary or epigastric region that enlarge to 4 to 5 mm in diameter and coalesce to form a confluent plaque with a peripheral reticulated pattern. CRP can extend over the back, chest, and abdomen to the neck, shoulders, and gluteal cleft. CRP does not affect the oral mucosa, and rarely involves flexural areas, which differentiates it from the similar looking acanthosis nigricans.² Although most cases are asymptomatic, mild pruritus may occur.^1,2

A skin biopsy is rarely necessary for making a CRP diagnosis, but histopathologic findings include papillomatosis, hyperkeratosis, variable acanthosis, follicular plugging, and sparse dermal inflammation.^1,3

Systemic antibiotics, most commonly minocycline 100 mg bid for 30 days or doxycycline 100 mg bid for 30 days, are safe and effective for CRP.^1,4 Sometimes treatment is extended for as long as 6 months. Although CRP usually responds to minocycline or doxycycline, it is believed that this is the result of these drugs’ anti-inflammatory—rather than antibiotic—properties.^1,2,4 Azithromycin is an effective alternative therapy.^2,4 There is a high rate of recurrence of CRP in patients after systemic antibiotics are discontinued.² Uniform responses to treatment and retreatment of flares have solidified the belief that antibiotics are an effective suppressive (if not curative) therapy despite a lack of randomized controlled trials.⁴

This patient was treated with minocycline 100 mg bid. After 1 month, the rash had improved by 70%. At 3 months, it was completely clear, and treatment was discontinued.

‌

This case was adapted from: Sessums MT, Ward KMH, Brodell R. Cutaneous eruption on chest and back. J Fam Pract. 2014;63:467-468.

This patient was given a diagnosis of confluent and reticulated papillomatosis (CRP) based on the clinical presentation.

CRP is characterized by centrally confluent and peripherally reticulated scaly brown plaques and papules that are cosmetically disfiguring.¹ CRP is usually asymptomatic and primarily impacts young adults—especially teenagers.^2,3 It affects both males and females and commonly occurs on the trunk.^1-3 CRP is believed to be a disorder of keratinization. Malassezia furfur may induce CRP’s hyperproliferative epidermal changes, but systemic treatment that eliminates this organism does not clear CRP.³

A CRP diagnosis is made based on clinical presentation. The eruption usually begins as verrucous papules in the inframammary or epigastric region that enlarge to 4 to 5 mm in diameter and coalesce to form a confluent plaque with a peripheral reticulated pattern. CRP can extend over the back, chest, and abdomen to the neck, shoulders, and gluteal cleft. CRP does not affect the oral mucosa, and rarely involves flexural areas, which differentiates it from the similar looking acanthosis nigricans.² Although most cases are asymptomatic, mild pruritus may occur.^1,2

A skin biopsy is rarely necessary for making a CRP diagnosis, but histopathologic findings include papillomatosis, hyperkeratosis, variable acanthosis, follicular plugging, and sparse dermal inflammation.^1,3

Systemic antibiotics, most commonly minocycline 100 mg bid for 30 days or doxycycline 100 mg bid for 30 days, are safe and effective for CRP.^1,4 Sometimes treatment is extended for as long as 6 months. Although CRP usually responds to minocycline or doxycycline, it is believed that this is the result of these drugs’ anti-inflammatory—rather than antibiotic—properties.^1,2,4 Azithromycin is an effective alternative therapy.^2,4 There is a high rate of recurrence of CRP in patients after systemic antibiotics are discontinued.² Uniform responses to treatment and retreatment of flares have solidified the belief that antibiotics are an effective suppressive (if not curative) therapy despite a lack of randomized controlled trials.⁴

This patient was treated with minocycline 100 mg bid. After 1 month, the rash had improved by 70%. At 3 months, it was completely clear, and treatment was discontinued.

‌

This case was adapted from: Sessums MT, Ward KMH, Brodell R. Cutaneous eruption on chest and back. J Fam Pract. 2014;63:467-468.