The Food and Drug Administration has approved midazolam (Nayzilam) nasal spray for the acute treatment of intermittent, stereotypic episodes of frequent seizure activity – seizure clusters or acute repetitive seizures – that are distinct from a patient’s usual seizure pattern. The treatment is approved for patients with epilepsy aged 12 years and older, according to a news release from UCB, the company that markets the drug.

Nayzilam is the first FDA-approved nasal option for treating seizure clusters, and the nasally administered formulation may allow for people other than healthcare professionals to administer the benzodiazepine in patients who are actively seizing when a seizure cluster occurs, according to the news release.

Nayzilam is designed as a single-use treatment that can be carried with a patient. The drug is a Schedule IV controlled substance.

Nayzilam’s efficacy was studied in a randomized, double-blind, placebo-controlled trial that enrolled patients with epilepsy who had intermittent, stereotypic episodes of frequent seizure activity that were distinct from the patient’s usual seizure pattern.

During an open-label phase, 292 patients in the absence of seizure received two 5-mg doses of Nayzilam 10 minutes apart. During the randomized, double-blind, placebo-controlled phase, 201 patients treated a single seizure cluster episode in an outpatient setting with Nayzilam (134 patients) or placebo (67 patients). If the seizure activity persisted or recurred, patients in both groups had the option to receive a subsequent unblinded dose of Nayzilam between 10 minutes and 6 hours after the initial blinded dose of study drug.

Compared with patients who received placebo, significantly more patients who received Nayzilam had termination of seizures within 10 minutes after the initial blinded dose of study drug (80.6% vs. 70.1%) and the absence of a recurrence of seizures within 6 hours of the initial blinded dose of study drug (58.2% vs. 37.3%). Adverse reactions that occurred in 5% or more of patients who received Nayzilam were somnolence, headache, nasal discomfort, throat irritation, and rhinorrhea.

Respiratory depression was observed with the administration of Nayzilam during clinical trials. Cardiac or respiratory arrest have occurred after administration of midazolam, and midazolam is associated with a high incidence of partial or complete impairment of recall for several hours following an administered dose. Nayzilam is contraindicated in patients with acute narrow-angle glaucoma. In addition, concomitant use of opioids, moderate or strong CYP3A4 inhibitors, or other CNS depressants entails risks. Antiepileptic drugs, including Nayzilam, increase the risk of suicidal thoughts or behavior, according to the announcement.




 

The Food and Drug Administration has approved midazolam (Nayzilam) nasal spray for the acute treatment of intermittent, stereotypic episodes of frequent seizure activity – seizure clusters or acute repetitive seizures – that are distinct from a patient’s usual seizure pattern. The treatment is approved for patients with epilepsy aged 12 years and older, according to a news release from UCB, the company that markets the drug.

Nayzilam is the first FDA-approved nasal option for treating seizure clusters, and the nasally administered formulation may allow for people other than healthcare professionals to administer the benzodiazepine in patients who are actively seizing when a seizure cluster occurs, according to the news release.

Nayzilam is designed as a single-use treatment that can be carried with a patient. The drug is a Schedule IV controlled substance.

Nayzilam’s efficacy was studied in a randomized, double-blind, placebo-controlled trial that enrolled patients with epilepsy who had intermittent, stereotypic episodes of frequent seizure activity that were distinct from the patient’s usual seizure pattern.

During an open-label phase, 292 patients in the absence of seizure received two 5-mg doses of Nayzilam 10 minutes apart. During the randomized, double-blind, placebo-controlled phase, 201 patients treated a single seizure cluster episode in an outpatient setting with Nayzilam (134 patients) or placebo (67 patients). If the seizure activity persisted or recurred, patients in both groups had the option to receive a subsequent unblinded dose of Nayzilam between 10 minutes and 6 hours after the initial blinded dose of study drug.

Compared with patients who received placebo, significantly more patients who received Nayzilam had termination of seizures within 10 minutes after the initial blinded dose of study drug (80.6% vs. 70.1%) and the absence of a recurrence of seizures within 6 hours of the initial blinded dose of study drug (58.2% vs. 37.3%). Adverse reactions that occurred in 5% or more of patients who received Nayzilam were somnolence, headache, nasal discomfort, throat irritation, and rhinorrhea.

Respiratory depression was observed with the administration of Nayzilam during clinical trials. Cardiac or respiratory arrest have occurred after administration of midazolam, and midazolam is associated with a high incidence of partial or complete impairment of recall for several hours following an administered dose. Nayzilam is contraindicated in patients with acute narrow-angle glaucoma. In addition, concomitant use of opioids, moderate or strong CYP3A4 inhibitors, or other CNS depressants entails risks. Antiepileptic drugs, including Nayzilam, increase the risk of suicidal thoughts or behavior, according to the announcement.




 

The Food and Drug Administration has approved midazolam (Nayzilam) nasal spray for the acute treatment of intermittent, stereotypic episodes of frequent seizure activity – seizure clusters or acute repetitive seizures – that are distinct from a patient’s usual seizure pattern. The treatment is approved for patients with epilepsy aged 12 years and older, according to a news release from UCB, the company that markets the drug.

Nayzilam is the first FDA-approved nasal option for treating seizure clusters, and the nasally administered formulation may allow for people other than healthcare professionals to administer the benzodiazepine in patients who are actively seizing when a seizure cluster occurs, according to the news release.

Nayzilam is designed as a single-use treatment that can be carried with a patient. The drug is a Schedule IV controlled substance.

Nayzilam’s efficacy was studied in a randomized, double-blind, placebo-controlled trial that enrolled patients with epilepsy who had intermittent, stereotypic episodes of frequent seizure activity that were distinct from the patient’s usual seizure pattern.

During an open-label phase, 292 patients in the absence of seizure received two 5-mg doses of Nayzilam 10 minutes apart. During the randomized, double-blind, placebo-controlled phase, 201 patients treated a single seizure cluster episode in an outpatient setting with Nayzilam (134 patients) or placebo (67 patients). If the seizure activity persisted or recurred, patients in both groups had the option to receive a subsequent unblinded dose of Nayzilam between 10 minutes and 6 hours after the initial blinded dose of study drug.

Compared with patients who received placebo, significantly more patients who received Nayzilam had termination of seizures within 10 minutes after the initial blinded dose of study drug (80.6% vs. 70.1%) and the absence of a recurrence of seizures within 6 hours of the initial blinded dose of study drug (58.2% vs. 37.3%). Adverse reactions that occurred in 5% or more of patients who received Nayzilam were somnolence, headache, nasal discomfort, throat irritation, and rhinorrhea.

Respiratory depression was observed with the administration of Nayzilam during clinical trials. Cardiac or respiratory arrest have occurred after administration of midazolam, and midazolam is associated with a high incidence of partial or complete impairment of recall for several hours following an administered dose. Nayzilam is contraindicated in patients with acute narrow-angle glaucoma. In addition, concomitant use of opioids, moderate or strong CYP3A4 inhibitors, or other CNS depressants entails risks. Antiepileptic drugs, including Nayzilam, increase the risk of suicidal thoughts or behavior, according to the announcement.




 

Last week, my secretary was checking a patient out when I went into the little galley area across from her desk to get coffee. Unfortunately, I knocked the pot over and it broke, sending glass and hot coffee everywhere.

wakila/Getty Images

My secretary asked the patient to wait a minute, grabbed a roll of paper towels that was behind her, and ran over to help me clean up. She was with me for 1-2 minutes, then returned to finish signing the patient out while I picked up glass shards.

A while later, we realized that somewhere in that 2 minutes an envelope containing roughly $200 in copays had disappeared from her desk drawer. It had been there 30 minutes before when another patient had paid a copay in cash, and now it was gone.

My secretary? No. She’s been with me for more than 15 years. She’s never stolen from the practice before, so why would she start now? I trust her.

The only people who had access to the drawer in that time were the patient, her, and me. While the money was out of sight, it was within reach of anyone who leaned over the counter, opened the drawer to look through it, and grabbed it.

I admit I probably should have gone to the bank sooner. Normally, we only have $20-$40 in small bills on hand, which we use for change. Most people prefer credit cards. But in the 2-3 weeks before this, we had had an unusual number of people using cash for copays. Combined with a crazier schedule than usual, I just hadn’t had a chance to deposit the bills.

Obviously, I’m not going to do that again.

Generally, no one has a chance to reach over and grab the drawer, either. When a patient is checking out, my secretary is always there making the transaction. But this one time, we had an unexpected distraction and she left the desk to help me.

She’s not going to do that again with someone standing there, either.

$200 isn’t, even in a small practice, a make-or-break amount. It stings, but I’ll still be able to make payroll and pay the rent. At the end of the year, it will have to come out of my own salary, because that’s the nature of owning a business. I can’t (and wouldn’t) charge the next 200 patients a $1 “administrative fee” to cover it.

Of course, it’s possible I’m accusing the wrong person. But there wasn’t anyone in the office besides me, my secretary, and the patient in that time frame. I don’t have any actual proof, like a video, though, so I certainly can’t press charges. She didn’t schedule a follow-up visit, either, so doubt she’ll be coming back.

Why would a patient steal from a doctor who’s trying to help her? Money is the simple answer. She had an opportunity to look and take it, and she did. Her moral compass must be skewed toward dishonesty, and she took advantage of the situation. I doubt it was anything personal against me, or doctors, or the situation in general. She’s a thief, and in her mind, it was a business decision.

Of course, I could be wrong on that point. Maybe she did rationalize it by the incorrect, but widespread, belief that doctors are “rich.” In her mind, she may have thought I’d never notice it, therefore there’s nothing wrong with stealing from me.

Do I hold it against future patients? No. In 20 years this is the first time one has stolen anything of significant financial value from my office (we’ve lost pens, magazines, a stapler, and a snowman-shaped candy dish in the past). The vast majority of my patients are decent people who wouldn’t do something like this.

But it does cast a pall over new patients we don’t know. Next time I need help while someone’s being checked out, my secretary won’t be able to give it. Any amount over a few small bills for change will be promptly taken to the bank.

It’s a bitter pill that leaves a bad taste in my mouth. Not harmful in the grand scheme of things, but certainly unpleasant. My job is based on the idea that people trust me to do my best for them, and in return, I trust them to be honest with me in return.

But one morning last week, it was just a one-way street.

Dr. Block has a solo neurology practice in Scottsdale, Ariz.

Last week, my secretary was checking a patient out when I went into the little galley area across from her desk to get coffee. Unfortunately, I knocked the pot over and it broke, sending glass and hot coffee everywhere.

wakila/Getty Images

My secretary asked the patient to wait a minute, grabbed a roll of paper towels that was behind her, and ran over to help me clean up. She was with me for 1-2 minutes, then returned to finish signing the patient out while I picked up glass shards.

A while later, we realized that somewhere in that 2 minutes an envelope containing roughly $200 in copays had disappeared from her desk drawer. It had been there 30 minutes before when another patient had paid a copay in cash, and now it was gone.

My secretary? No. She’s been with me for more than 15 years. She’s never stolen from the practice before, so why would she start now? I trust her.

The only people who had access to the drawer in that time were the patient, her, and me. While the money was out of sight, it was within reach of anyone who leaned over the counter, opened the drawer to look through it, and grabbed it.

I admit I probably should have gone to the bank sooner. Normally, we only have $20-$40 in small bills on hand, which we use for change. Most people prefer credit cards. But in the 2-3 weeks before this, we had had an unusual number of people using cash for copays. Combined with a crazier schedule than usual, I just hadn’t had a chance to deposit the bills.

Obviously, I’m not going to do that again.

Generally, no one has a chance to reach over and grab the drawer, either. When a patient is checking out, my secretary is always there making the transaction. But this one time, we had an unexpected distraction and she left the desk to help me.

She’s not going to do that again with someone standing there, either.

$200 isn’t, even in a small practice, a make-or-break amount. It stings, but I’ll still be able to make payroll and pay the rent. At the end of the year, it will have to come out of my own salary, because that’s the nature of owning a business. I can’t (and wouldn’t) charge the next 200 patients a $1 “administrative fee” to cover it.

Of course, it’s possible I’m accusing the wrong person. But there wasn’t anyone in the office besides me, my secretary, and the patient in that time frame. I don’t have any actual proof, like a video, though, so I certainly can’t press charges. She didn’t schedule a follow-up visit, either, so doubt she’ll be coming back.

Why would a patient steal from a doctor who’s trying to help her? Money is the simple answer. She had an opportunity to look and take it, and she did. Her moral compass must be skewed toward dishonesty, and she took advantage of the situation. I doubt it was anything personal against me, or doctors, or the situation in general. She’s a thief, and in her mind, it was a business decision.

Of course, I could be wrong on that point. Maybe she did rationalize it by the incorrect, but widespread, belief that doctors are “rich.” In her mind, she may have thought I’d never notice it, therefore there’s nothing wrong with stealing from me.

Do I hold it against future patients? No. In 20 years this is the first time one has stolen anything of significant financial value from my office (we’ve lost pens, magazines, a stapler, and a snowman-shaped candy dish in the past). The vast majority of my patients are decent people who wouldn’t do something like this.

But it does cast a pall over new patients we don’t know. Next time I need help while someone’s being checked out, my secretary won’t be able to give it. Any amount over a few small bills for change will be promptly taken to the bank.

It’s a bitter pill that leaves a bad taste in my mouth. Not harmful in the grand scheme of things, but certainly unpleasant. My job is based on the idea that people trust me to do my best for them, and in return, I trust them to be honest with me in return.

But one morning last week, it was just a one-way street.

Dr. Block has a solo neurology practice in Scottsdale, Ariz.

Last week, my secretary was checking a patient out when I went into the little galley area across from her desk to get coffee. Unfortunately, I knocked the pot over and it broke, sending glass and hot coffee everywhere.

wakila/Getty Images

My secretary asked the patient to wait a minute, grabbed a roll of paper towels that was behind her, and ran over to help me clean up. She was with me for 1-2 minutes, then returned to finish signing the patient out while I picked up glass shards.

A while later, we realized that somewhere in that 2 minutes an envelope containing roughly $200 in copays had disappeared from her desk drawer. It had been there 30 minutes before when another patient had paid a copay in cash, and now it was gone.

My secretary? No. She’s been with me for more than 15 years. She’s never stolen from the practice before, so why would she start now? I trust her.

The only people who had access to the drawer in that time were the patient, her, and me. While the money was out of sight, it was within reach of anyone who leaned over the counter, opened the drawer to look through it, and grabbed it.

I admit I probably should have gone to the bank sooner. Normally, we only have $20-$40 in small bills on hand, which we use for change. Most people prefer credit cards. But in the 2-3 weeks before this, we had had an unusual number of people using cash for copays. Combined with a crazier schedule than usual, I just hadn’t had a chance to deposit the bills.

Obviously, I’m not going to do that again.

Generally, no one has a chance to reach over and grab the drawer, either. When a patient is checking out, my secretary is always there making the transaction. But this one time, we had an unexpected distraction and she left the desk to help me.

She’s not going to do that again with someone standing there, either.

$200 isn’t, even in a small practice, a make-or-break amount. It stings, but I’ll still be able to make payroll and pay the rent. At the end of the year, it will have to come out of my own salary, because that’s the nature of owning a business. I can’t (and wouldn’t) charge the next 200 patients a $1 “administrative fee” to cover it.

Of course, it’s possible I’m accusing the wrong person. But there wasn’t anyone in the office besides me, my secretary, and the patient in that time frame. I don’t have any actual proof, like a video, though, so I certainly can’t press charges. She didn’t schedule a follow-up visit, either, so doubt she’ll be coming back.

Why would a patient steal from a doctor who’s trying to help her? Money is the simple answer. She had an opportunity to look and take it, and she did. Her moral compass must be skewed toward dishonesty, and she took advantage of the situation. I doubt it was anything personal against me, or doctors, or the situation in general. She’s a thief, and in her mind, it was a business decision.

Of course, I could be wrong on that point. Maybe she did rationalize it by the incorrect, but widespread, belief that doctors are “rich.” In her mind, she may have thought I’d never notice it, therefore there’s nothing wrong with stealing from me.

Do I hold it against future patients? No. In 20 years this is the first time one has stolen anything of significant financial value from my office (we’ve lost pens, magazines, a stapler, and a snowman-shaped candy dish in the past). The vast majority of my patients are decent people who wouldn’t do something like this.

But it does cast a pall over new patients we don’t know. Next time I need help while someone’s being checked out, my secretary won’t be able to give it. Any amount over a few small bills for change will be promptly taken to the bank.

It’s a bitter pill that leaves a bad taste in my mouth. Not harmful in the grand scheme of things, but certainly unpleasant. My job is based on the idea that people trust me to do my best for them, and in return, I trust them to be honest with me in return.

But one morning last week, it was just a one-way street.

Dr. Block has a solo neurology practice in Scottsdale, Ariz.

CHICAGO – Compared with that of calcineurin inhibitors, belatacept appears to be associated with a lower risk of keratinocyte carcinomas in solid organ transplant patients, based on results from a single-center analysis presented at the annual meeting of the Society for Investigative Dermatology.

“Belatacept may offer a better risk-benefit profile in regards to skin cancer,” reported Michael Wang, a medical student who conducted this research in collaboration with the senior author, Oscar Colegio, MD, PhD, an associate professor of dermatology, pathology, and surgery at Yale University, New Haven, Conn.

Belatacept, a CTLA-4 fusion protein, has been compared with calcineurin inhibitors in two previous studies. The results were equivocal in one, and the other found no difference in risk and could not rule out the possibility that skin cancer risk was even higher on belatacept.

This single-center chart review included 110 kidney transplant patients, median age 58 years, who were switched from a calcineurin inhibitor, such as cyclosporine or tacrolimus, to belatacept. Ultimately, the study was limited to the 66 patients with at least 2 years of dermatologic follow-up both before and after the switch from a calcineurin inhibitor.

The primary outcome was the number of keratinocyte carcinomas overall and, specifically, the number of squamous cell carcinomas (SCCs) before and after the switch. Over the course of this study there were 128 cutaneous malignancies, 83 of which were SCCs.

When patients were on a calcineurin inhibitor, the risk of keratinocyte carcinomas increased incrementally by 2.6 events per 100 patients per year of follow-up, and the risk of SCCs increased by 1.7 events per 100 patients per year of follow-up. In the first 6 months after the switch to belatacept, there was no change in the rising trajectory of skin cancers, but rates declined thereafter.

Relative to rates prior to and 6 months after the switch, “the incidence of SCCs decreased at a rate of 5.9 events per 100 patients per year (P = .0068), and the incidence of keratinocyte carcinomas decreased by 7.1 events per 100 patients per year (P = .003),” Mr. Wang reported. He noted, however, that the incidence of basal cell carcinomas and melanomas following the switch remained unchanged.

When patients switched to belatacept were compared with another group of patients who remained on a calcineurin inhibitor after developing a SCC, the hazard ratio for a new SCC was 0.42, indicating a greater than 50% reduction in risk.

In patients on calcineurin inhibitors, the risk of keratinocyte carcinomas appears to be related to a direct effect of these agents on keratinocyte dedifferentiation. Belatacept is not believed to have any direct effects on keratinocytes, according to Mr. Wang.

As the chart review was retrospective and limited to a single center, “we hope [the findings] will encourage a prospective trial,” Mr. Wang said.

SOURCE: Wang M. SID 2019, Abstract 532.

CHICAGO – Compared with that of calcineurin inhibitors, belatacept appears to be associated with a lower risk of keratinocyte carcinomas in solid organ transplant patients, based on results from a single-center analysis presented at the annual meeting of the Society for Investigative Dermatology.

“Belatacept may offer a better risk-benefit profile in regards to skin cancer,” reported Michael Wang, a medical student who conducted this research in collaboration with the senior author, Oscar Colegio, MD, PhD, an associate professor of dermatology, pathology, and surgery at Yale University, New Haven, Conn.

Belatacept, a CTLA-4 fusion protein, has been compared with calcineurin inhibitors in two previous studies. The results were equivocal in one, and the other found no difference in risk and could not rule out the possibility that skin cancer risk was even higher on belatacept.

This single-center chart review included 110 kidney transplant patients, median age 58 years, who were switched from a calcineurin inhibitor, such as cyclosporine or tacrolimus, to belatacept. Ultimately, the study was limited to the 66 patients with at least 2 years of dermatologic follow-up both before and after the switch from a calcineurin inhibitor.

The primary outcome was the number of keratinocyte carcinomas overall and, specifically, the number of squamous cell carcinomas (SCCs) before and after the switch. Over the course of this study there were 128 cutaneous malignancies, 83 of which were SCCs.

When patients were on a calcineurin inhibitor, the risk of keratinocyte carcinomas increased incrementally by 2.6 events per 100 patients per year of follow-up, and the risk of SCCs increased by 1.7 events per 100 patients per year of follow-up. In the first 6 months after the switch to belatacept, there was no change in the rising trajectory of skin cancers, but rates declined thereafter.

Relative to rates prior to and 6 months after the switch, “the incidence of SCCs decreased at a rate of 5.9 events per 100 patients per year (P = .0068), and the incidence of keratinocyte carcinomas decreased by 7.1 events per 100 patients per year (P = .003),” Mr. Wang reported. He noted, however, that the incidence of basal cell carcinomas and melanomas following the switch remained unchanged.

When patients switched to belatacept were compared with another group of patients who remained on a calcineurin inhibitor after developing a SCC, the hazard ratio for a new SCC was 0.42, indicating a greater than 50% reduction in risk.

In patients on calcineurin inhibitors, the risk of keratinocyte carcinomas appears to be related to a direct effect of these agents on keratinocyte dedifferentiation. Belatacept is not believed to have any direct effects on keratinocytes, according to Mr. Wang.

As the chart review was retrospective and limited to a single center, “we hope [the findings] will encourage a prospective trial,” Mr. Wang said.

SOURCE: Wang M. SID 2019, Abstract 532.

CHICAGO – Compared with that of calcineurin inhibitors, belatacept appears to be associated with a lower risk of keratinocyte carcinomas in solid organ transplant patients, based on results from a single-center analysis presented at the annual meeting of the Society for Investigative Dermatology.

“Belatacept may offer a better risk-benefit profile in regards to skin cancer,” reported Michael Wang, a medical student who conducted this research in collaboration with the senior author, Oscar Colegio, MD, PhD, an associate professor of dermatology, pathology, and surgery at Yale University, New Haven, Conn.

Belatacept, a CTLA-4 fusion protein, has been compared with calcineurin inhibitors in two previous studies. The results were equivocal in one, and the other found no difference in risk and could not rule out the possibility that skin cancer risk was even higher on belatacept.

This single-center chart review included 110 kidney transplant patients, median age 58 years, who were switched from a calcineurin inhibitor, such as cyclosporine or tacrolimus, to belatacept. Ultimately, the study was limited to the 66 patients with at least 2 years of dermatologic follow-up both before and after the switch from a calcineurin inhibitor.

The primary outcome was the number of keratinocyte carcinomas overall and, specifically, the number of squamous cell carcinomas (SCCs) before and after the switch. Over the course of this study there were 128 cutaneous malignancies, 83 of which were SCCs.

When patients were on a calcineurin inhibitor, the risk of keratinocyte carcinomas increased incrementally by 2.6 events per 100 patients per year of follow-up, and the risk of SCCs increased by 1.7 events per 100 patients per year of follow-up. In the first 6 months after the switch to belatacept, there was no change in the rising trajectory of skin cancers, but rates declined thereafter.

Relative to rates prior to and 6 months after the switch, “the incidence of SCCs decreased at a rate of 5.9 events per 100 patients per year (P = .0068), and the incidence of keratinocyte carcinomas decreased by 7.1 events per 100 patients per year (P = .003),” Mr. Wang reported. He noted, however, that the incidence of basal cell carcinomas and melanomas following the switch remained unchanged.

When patients switched to belatacept were compared with another group of patients who remained on a calcineurin inhibitor after developing a SCC, the hazard ratio for a new SCC was 0.42, indicating a greater than 50% reduction in risk.

In patients on calcineurin inhibitors, the risk of keratinocyte carcinomas appears to be related to a direct effect of these agents on keratinocyte dedifferentiation. Belatacept is not believed to have any direct effects on keratinocytes, according to Mr. Wang.

As the chart review was retrospective and limited to a single center, “we hope [the findings] will encourage a prospective trial,” Mr. Wang said.

SOURCE: Wang M. SID 2019, Abstract 532.

To the Editor:

A 56-year-old white woman with a history of melanoma and hypertension presented for evaluation of progressive hair loss of more than 1 year’s duration with associated pruritis. Scalp examination revealed diffuse erythema and scarring alopecia of the bilateral parietal and temporal regions. Physical examination also revealed nonscarring alopecia of the bilateral axillae, with associated thinning of the pubic hair, eyebrows, and eyelashes, as well as keratosis pilaris on the upper arms. Biopsy of the parietal scalp revealed mild scarring alopecia with isthmic fibroplasia consistent with early lichen planopilaris (LPP)(Figure). These histologic features combined with the patient’s clinical presentation were consistent with a diagnosis of Graham-Little-Piccardi-Lassueur syndrome (GLPL).

Graham-Little-Piccardi-Lassueur syndrome was first described by Piccardi in 1913.A second case was then described by Graham-Little in 1915 in a patient referred by Lassueur, resulting in the name it bears today.^1,2 The condition presents most commonly in middle-aged white women and is characterized by a triad of cicatricial alopecia of the scalp, nonscarring alopecia of the axillae and/or groin, and a rough follicular eruption on the body and/or scalp. Symptoms may not be present simultaneously. In GLPL, scarring alopecia of the scalp often precedes follicular eruptions of the trunk, arms, and legs by as much as years,² and the inverse also has been reported.¹ The inflammatory lesions of the scalp eventually resolve spontaneously, but the hair loss is by definition irreversible.

This rare condition is considered one of the 3 clinical variants of LPP. Other variants include classic LPP, also known as follicular lichen planus, and frontal fibrosing alopecia.³ More recently, fibrosing alopecia in a pattern distribution has gained some popularity as a fourth variant of LPP.⁴ All variants of LPP, including GLPL, result in a scarring alopecia. The classic scalp finding is an erythematous to violaceous, perifollicular, hyperkeratotic scale at the base of the terminal hairs. The population of inflamed follicles spreads outward, leaving behind a round to oval, central, atrophic scar that often is devoid of follicles. Few hairs may persist within zones of alopecia at presentation; however, these hairs are affected by inflammation and also will likely shed. A hair pull test will be positive at the margins during active disease, consisting of mostly anagen hairs on trichogram examination.^1,5 Patients may develop only a single foci of hair loss, but much more commonly, a patchy multifocal alopecia is noted.⁶ Sites often will coalesce. Onset of scalp alopecia may be insidious or fulminant.

The nonscarring alopecia of the axillae and groin may be described as subtle thinning to complete hair loss with no signs of atrophy or inflammation. Although not commonly reported, a case of nonscarring alopecia located on the shoulders has been seen.⁷

The follicular eruption that can be present on the trunk, arms, or legs in GLPL is most often but not limited to keratosis pilaris, as was seen in our patient. One reported case also described lichen spinulosus as a potential variant.⁸ Lichen planopilaris is separate from lichen planus (LP) because of its selective follicular involvement vs the nonselective mucocutaneous distribution of LP. The 2 processes also are histologically distinct; however, estimations have shown that more than 50% of patients with GLPL experience at least 1 episode of mucosal or cutaneous LP in their lifetime.⁹ Rarely, coexistence of GLPL and LP lesions has been described. One reported case of GLPL and concomitant hypertrophic LP could represent a severe form of the disease.⁹ Additionally, lichen planus pigmentosus, an uncommon variant of LP characterized by hyperpigmented brown macules in sun-exposed areas and flexural folds, was identified in a case report of an Asian woman with GLPL.¹⁰

As a general rule, the variants of LPP most commonly are seen in postmenopausal women aged 40 to 60 years; however, rare cases in a child and a teenager have been reported.¹¹ The GLPL variant of LPP is reported up to 4 times more frequently in females.⁵ Pruritus and pain are inconsistent findings, and there are no systemic signs of illness. A case of androgen insensitivity syndrome associated with GLPL suggested a potential influence of hormones in LPP.¹² Stress, vitamin A deficiency, and autoimmunity also have been proposed as triggers of GLPL.¹³ Furthermore, familial GLPL was described in a mother and daughter, though the association was uncertain.¹⁴ Our patient had no relevant family history.

Workups to reveal the etiology of GLPL have been inconclusive. Reports of laboratory testing including complete blood cell count, basic metabolic panel, liver function tests, testosterone and dehydroepiandrosterone levels, and chest radiograph have been normal.² Additional workup for viral triggers also has been negative.¹⁵ A case series of 29 patients with LPP and its variants, including GLPL, revealed positive antinuclear antibodies in 10% of patients and a thyroid disorder in 24% of patients, with Hashimoto thyroiditis being the most prevalent in 7% of cases.¹⁶ There may be a strong association between the comorbidities of thyroid dysfunction and GLPL, as documented in other studies.^10,17 A case-control study by Mesinkovska et al¹⁷ revealed a considerable increase in the prevalence of thyroid gland disease among patients with LPP vs controls. Human leukocyte antigen DR1 was found in a familial case of GLPL,⁴ and a case of GLPL following hepatitis B vaccination also has been described.¹⁸

Graham-Little-Piccardi-Lassueur syndrome most likely is a T-cell mediated autoimmune condition associated with one or multiple unknown keratinocyte antigens. Autoantibodies to the inner centromere protein were identified in a case that was positive on direct immunofluorescence, which may provide more insight into the disease pathophysiology.¹³ Interestingly, a study comparing the concentrations of inflammatory cells in LPP and traction alopecia found an elevation in the ratio of Langerhans cells to T lymphocytes within the follicular inflammatory infiltrate of LPP.¹⁹

Because the number of patients with GLPL is so few, therapy should mirror advances being made in treatments for other variants of LPP. More recent studies of LPP treatment with hydroxychloroquine showed opposing results, though the safety profile of this agent makes it an enticing treatment option.^22,23 Tetracyclines showed improvement in 4 of 15 (26.7%) patients in a retrospective study by Spencer et al.²⁴ Another retrospective study showed promising results with the potent 5-alpha reductase inhibitor dutasteride with 7 of 10 (70%) postmenopausal patients reporting stabilization over a mean duration of 28 months with no reported side effects.²⁵ Antimalarial medications also have been implemented as adjunct therapies with mixed results.⁵ A case of a 26-year-old man with GLPL from South India showed systemic disease improvement following treatment with pulsed systemic steroids, isotretinoin, and anxiolytics.⁷ Chloroquine phosphate at a daily dose of 150 mg for 3 to 9 months yielded a transient response in one postmenopausal patient with frontal fibrosing alopecia.⁶ Stabilization of hair loss was achieved with a combination of hydroxychloroquine and doxycycline in a woman with GLPL who was previously unresponsive to tacrolimus ointment.¹⁰ Thalidomide showed early promise in an isolated report claiming successful treatment of LPP,²⁶ but there is contradictory evidence, as thalidomide showed no benefit in a series of 4 patients with LPP.²⁷

Peroxisome proliferator–activated receptor gamma (PPAR-γ), a transcription factor that regulates genes, is downregulated in LPP.²⁸ Deletion of PPAR-γ within follicular stem cells in mice results in a phenotype similar to cicatricial alopecia. Data have supported the role of PPAR-γ in maintaining the pilosebaceous unit. A case report of pioglitazone (PPAR-γ agonist) therapy used at 15 mg daily for 8 months was successful in treating a patient with LPP.²⁸ Further investigation must be conducted to evaluate these treatments since early attenuation of the disease process is crucial to the reduction of permanent hair loss.

Advances in the early recognition and successful treatment of GLPL are dependent on continued research in all variants of LPP. Randomized controlled trials are necessary to establish standard of care. Further studies should target the association of GLPL and other autoimmune phenomena. Moreover, research into the etiology will provide direction in understanding disease progression and outcome.

To the Editor:

A 56-year-old white woman with a history of melanoma and hypertension presented for evaluation of progressive hair loss of more than 1 year’s duration with associated pruritis. Scalp examination revealed diffuse erythema and scarring alopecia of the bilateral parietal and temporal regions. Physical examination also revealed nonscarring alopecia of the bilateral axillae, with associated thinning of the pubic hair, eyebrows, and eyelashes, as well as keratosis pilaris on the upper arms. Biopsy of the parietal scalp revealed mild scarring alopecia with isthmic fibroplasia consistent with early lichen planopilaris (LPP)(Figure). These histologic features combined with the patient’s clinical presentation were consistent with a diagnosis of Graham-Little-Piccardi-Lassueur syndrome (GLPL).

Graham-Little-Piccardi-Lassueur syndrome was first described by Piccardi in 1913.A second case was then described by Graham-Little in 1915 in a patient referred by Lassueur, resulting in the name it bears today.^1,2 The condition presents most commonly in middle-aged white women and is characterized by a triad of cicatricial alopecia of the scalp, nonscarring alopecia of the axillae and/or groin, and a rough follicular eruption on the body and/or scalp. Symptoms may not be present simultaneously. In GLPL, scarring alopecia of the scalp often precedes follicular eruptions of the trunk, arms, and legs by as much as years,² and the inverse also has been reported.¹ The inflammatory lesions of the scalp eventually resolve spontaneously, but the hair loss is by definition irreversible.

This rare condition is considered one of the 3 clinical variants of LPP. Other variants include classic LPP, also known as follicular lichen planus, and frontal fibrosing alopecia.³ More recently, fibrosing alopecia in a pattern distribution has gained some popularity as a fourth variant of LPP.⁴ All variants of LPP, including GLPL, result in a scarring alopecia. The classic scalp finding is an erythematous to violaceous, perifollicular, hyperkeratotic scale at the base of the terminal hairs. The population of inflamed follicles spreads outward, leaving behind a round to oval, central, atrophic scar that often is devoid of follicles. Few hairs may persist within zones of alopecia at presentation; however, these hairs are affected by inflammation and also will likely shed. A hair pull test will be positive at the margins during active disease, consisting of mostly anagen hairs on trichogram examination.^1,5 Patients may develop only a single foci of hair loss, but much more commonly, a patchy multifocal alopecia is noted.⁶ Sites often will coalesce. Onset of scalp alopecia may be insidious or fulminant.

The nonscarring alopecia of the axillae and groin may be described as subtle thinning to complete hair loss with no signs of atrophy or inflammation. Although not commonly reported, a case of nonscarring alopecia located on the shoulders has been seen.⁷

The follicular eruption that can be present on the trunk, arms, or legs in GLPL is most often but not limited to keratosis pilaris, as was seen in our patient. One reported case also described lichen spinulosus as a potential variant.⁸ Lichen planopilaris is separate from lichen planus (LP) because of its selective follicular involvement vs the nonselective mucocutaneous distribution of LP. The 2 processes also are histologically distinct; however, estimations have shown that more than 50% of patients with GLPL experience at least 1 episode of mucosal or cutaneous LP in their lifetime.⁹ Rarely, coexistence of GLPL and LP lesions has been described. One reported case of GLPL and concomitant hypertrophic LP could represent a severe form of the disease.⁹ Additionally, lichen planus pigmentosus, an uncommon variant of LP characterized by hyperpigmented brown macules in sun-exposed areas and flexural folds, was identified in a case report of an Asian woman with GLPL.¹⁰

As a general rule, the variants of LPP most commonly are seen in postmenopausal women aged 40 to 60 years; however, rare cases in a child and a teenager have been reported.¹¹ The GLPL variant of LPP is reported up to 4 times more frequently in females.⁵ Pruritus and pain are inconsistent findings, and there are no systemic signs of illness. A case of androgen insensitivity syndrome associated with GLPL suggested a potential influence of hormones in LPP.¹² Stress, vitamin A deficiency, and autoimmunity also have been proposed as triggers of GLPL.¹³ Furthermore, familial GLPL was described in a mother and daughter, though the association was uncertain.¹⁴ Our patient had no relevant family history.

Workups to reveal the etiology of GLPL have been inconclusive. Reports of laboratory testing including complete blood cell count, basic metabolic panel, liver function tests, testosterone and dehydroepiandrosterone levels, and chest radiograph have been normal.² Additional workup for viral triggers also has been negative.¹⁵ A case series of 29 patients with LPP and its variants, including GLPL, revealed positive antinuclear antibodies in 10% of patients and a thyroid disorder in 24% of patients, with Hashimoto thyroiditis being the most prevalent in 7% of cases.¹⁶ There may be a strong association between the comorbidities of thyroid dysfunction and GLPL, as documented in other studies.^10,17 A case-control study by Mesinkovska et al¹⁷ revealed a considerable increase in the prevalence of thyroid gland disease among patients with LPP vs controls. Human leukocyte antigen DR1 was found in a familial case of GLPL,⁴ and a case of GLPL following hepatitis B vaccination also has been described.¹⁸

Graham-Little-Piccardi-Lassueur syndrome most likely is a T-cell mediated autoimmune condition associated with one or multiple unknown keratinocyte antigens. Autoantibodies to the inner centromere protein were identified in a case that was positive on direct immunofluorescence, which may provide more insight into the disease pathophysiology.¹³ Interestingly, a study comparing the concentrations of inflammatory cells in LPP and traction alopecia found an elevation in the ratio of Langerhans cells to T lymphocytes within the follicular inflammatory infiltrate of LPP.¹⁹

Because the number of patients with GLPL is so few, therapy should mirror advances being made in treatments for other variants of LPP. More recent studies of LPP treatment with hydroxychloroquine showed opposing results, though the safety profile of this agent makes it an enticing treatment option.^22,23 Tetracyclines showed improvement in 4 of 15 (26.7%) patients in a retrospective study by Spencer et al.²⁴ Another retrospective study showed promising results with the potent 5-alpha reductase inhibitor dutasteride with 7 of 10 (70%) postmenopausal patients reporting stabilization over a mean duration of 28 months with no reported side effects.²⁵ Antimalarial medications also have been implemented as adjunct therapies with mixed results.⁵ A case of a 26-year-old man with GLPL from South India showed systemic disease improvement following treatment with pulsed systemic steroids, isotretinoin, and anxiolytics.⁷ Chloroquine phosphate at a daily dose of 150 mg for 3 to 9 months yielded a transient response in one postmenopausal patient with frontal fibrosing alopecia.⁶ Stabilization of hair loss was achieved with a combination of hydroxychloroquine and doxycycline in a woman with GLPL who was previously unresponsive to tacrolimus ointment.¹⁰ Thalidomide showed early promise in an isolated report claiming successful treatment of LPP,²⁶ but there is contradictory evidence, as thalidomide showed no benefit in a series of 4 patients with LPP.²⁷

Peroxisome proliferator–activated receptor gamma (PPAR-γ), a transcription factor that regulates genes, is downregulated in LPP.²⁸ Deletion of PPAR-γ within follicular stem cells in mice results in a phenotype similar to cicatricial alopecia. Data have supported the role of PPAR-γ in maintaining the pilosebaceous unit. A case report of pioglitazone (PPAR-γ agonist) therapy used at 15 mg daily for 8 months was successful in treating a patient with LPP.²⁸ Further investigation must be conducted to evaluate these treatments since early attenuation of the disease process is crucial to the reduction of permanent hair loss.

Advances in the early recognition and successful treatment of GLPL are dependent on continued research in all variants of LPP. Randomized controlled trials are necessary to establish standard of care. Further studies should target the association of GLPL and other autoimmune phenomena. Moreover, research into the etiology will provide direction in understanding disease progression and outcome.

To the Editor:

A 56-year-old white woman with a history of melanoma and hypertension presented for evaluation of progressive hair loss of more than 1 year’s duration with associated pruritis. Scalp examination revealed diffuse erythema and scarring alopecia of the bilateral parietal and temporal regions. Physical examination also revealed nonscarring alopecia of the bilateral axillae, with associated thinning of the pubic hair, eyebrows, and eyelashes, as well as keratosis pilaris on the upper arms. Biopsy of the parietal scalp revealed mild scarring alopecia with isthmic fibroplasia consistent with early lichen planopilaris (LPP)(Figure). These histologic features combined with the patient’s clinical presentation were consistent with a diagnosis of Graham-Little-Piccardi-Lassueur syndrome (GLPL).

Graham-Little-Piccardi-Lassueur syndrome was first described by Piccardi in 1913.A second case was then described by Graham-Little in 1915 in a patient referred by Lassueur, resulting in the name it bears today.^1,2 The condition presents most commonly in middle-aged white women and is characterized by a triad of cicatricial alopecia of the scalp, nonscarring alopecia of the axillae and/or groin, and a rough follicular eruption on the body and/or scalp. Symptoms may not be present simultaneously. In GLPL, scarring alopecia of the scalp often precedes follicular eruptions of the trunk, arms, and legs by as much as years,² and the inverse also has been reported.¹ The inflammatory lesions of the scalp eventually resolve spontaneously, but the hair loss is by definition irreversible.

This rare condition is considered one of the 3 clinical variants of LPP. Other variants include classic LPP, also known as follicular lichen planus, and frontal fibrosing alopecia.³ More recently, fibrosing alopecia in a pattern distribution has gained some popularity as a fourth variant of LPP.⁴ All variants of LPP, including GLPL, result in a scarring alopecia. The classic scalp finding is an erythematous to violaceous, perifollicular, hyperkeratotic scale at the base of the terminal hairs. The population of inflamed follicles spreads outward, leaving behind a round to oval, central, atrophic scar that often is devoid of follicles. Few hairs may persist within zones of alopecia at presentation; however, these hairs are affected by inflammation and also will likely shed. A hair pull test will be positive at the margins during active disease, consisting of mostly anagen hairs on trichogram examination.^1,5 Patients may develop only a single foci of hair loss, but much more commonly, a patchy multifocal alopecia is noted.⁶ Sites often will coalesce. Onset of scalp alopecia may be insidious or fulminant.

The nonscarring alopecia of the axillae and groin may be described as subtle thinning to complete hair loss with no signs of atrophy or inflammation. Although not commonly reported, a case of nonscarring alopecia located on the shoulders has been seen.⁷

The follicular eruption that can be present on the trunk, arms, or legs in GLPL is most often but not limited to keratosis pilaris, as was seen in our patient. One reported case also described lichen spinulosus as a potential variant.⁸ Lichen planopilaris is separate from lichen planus (LP) because of its selective follicular involvement vs the nonselective mucocutaneous distribution of LP. The 2 processes also are histologically distinct; however, estimations have shown that more than 50% of patients with GLPL experience at least 1 episode of mucosal or cutaneous LP in their lifetime.⁹ Rarely, coexistence of GLPL and LP lesions has been described. One reported case of GLPL and concomitant hypertrophic LP could represent a severe form of the disease.⁹ Additionally, lichen planus pigmentosus, an uncommon variant of LP characterized by hyperpigmented brown macules in sun-exposed areas and flexural folds, was identified in a case report of an Asian woman with GLPL.¹⁰

As a general rule, the variants of LPP most commonly are seen in postmenopausal women aged 40 to 60 years; however, rare cases in a child and a teenager have been reported.¹¹ The GLPL variant of LPP is reported up to 4 times more frequently in females.⁵ Pruritus and pain are inconsistent findings, and there are no systemic signs of illness. A case of androgen insensitivity syndrome associated with GLPL suggested a potential influence of hormones in LPP.¹² Stress, vitamin A deficiency, and autoimmunity also have been proposed as triggers of GLPL.¹³ Furthermore, familial GLPL was described in a mother and daughter, though the association was uncertain.¹⁴ Our patient had no relevant family history.

Workups to reveal the etiology of GLPL have been inconclusive. Reports of laboratory testing including complete blood cell count, basic metabolic panel, liver function tests, testosterone and dehydroepiandrosterone levels, and chest radiograph have been normal.² Additional workup for viral triggers also has been negative.¹⁵ A case series of 29 patients with LPP and its variants, including GLPL, revealed positive antinuclear antibodies in 10% of patients and a thyroid disorder in 24% of patients, with Hashimoto thyroiditis being the most prevalent in 7% of cases.¹⁶ There may be a strong association between the comorbidities of thyroid dysfunction and GLPL, as documented in other studies.^10,17 A case-control study by Mesinkovska et al¹⁷ revealed a considerable increase in the prevalence of thyroid gland disease among patients with LPP vs controls. Human leukocyte antigen DR1 was found in a familial case of GLPL,⁴ and a case of GLPL following hepatitis B vaccination also has been described.¹⁸

Graham-Little-Piccardi-Lassueur syndrome most likely is a T-cell mediated autoimmune condition associated with one or multiple unknown keratinocyte antigens. Autoantibodies to the inner centromere protein were identified in a case that was positive on direct immunofluorescence, which may provide more insight into the disease pathophysiology.¹³ Interestingly, a study comparing the concentrations of inflammatory cells in LPP and traction alopecia found an elevation in the ratio of Langerhans cells to T lymphocytes within the follicular inflammatory infiltrate of LPP.¹⁹

Because the number of patients with GLPL is so few, therapy should mirror advances being made in treatments for other variants of LPP. More recent studies of LPP treatment with hydroxychloroquine showed opposing results, though the safety profile of this agent makes it an enticing treatment option.^22,23 Tetracyclines showed improvement in 4 of 15 (26.7%) patients in a retrospective study by Spencer et al.²⁴ Another retrospective study showed promising results with the potent 5-alpha reductase inhibitor dutasteride with 7 of 10 (70%) postmenopausal patients reporting stabilization over a mean duration of 28 months with no reported side effects.²⁵ Antimalarial medications also have been implemented as adjunct therapies with mixed results.⁵ A case of a 26-year-old man with GLPL from South India showed systemic disease improvement following treatment with pulsed systemic steroids, isotretinoin, and anxiolytics.⁷ Chloroquine phosphate at a daily dose of 150 mg for 3 to 9 months yielded a transient response in one postmenopausal patient with frontal fibrosing alopecia.⁶ Stabilization of hair loss was achieved with a combination of hydroxychloroquine and doxycycline in a woman with GLPL who was previously unresponsive to tacrolimus ointment.¹⁰ Thalidomide showed early promise in an isolated report claiming successful treatment of LPP,²⁶ but there is contradictory evidence, as thalidomide showed no benefit in a series of 4 patients with LPP.²⁷

Peroxisome proliferator–activated receptor gamma (PPAR-γ), a transcription factor that regulates genes, is downregulated in LPP.²⁸ Deletion of PPAR-γ within follicular stem cells in mice results in a phenotype similar to cicatricial alopecia. Data have supported the role of PPAR-γ in maintaining the pilosebaceous unit. A case report of pioglitazone (PPAR-γ agonist) therapy used at 15 mg daily for 8 months was successful in treating a patient with LPP.²⁸ Further investigation must be conducted to evaluate these treatments since early attenuation of the disease process is crucial to the reduction of permanent hair loss.

Advances in the early recognition and successful treatment of GLPL are dependent on continued research in all variants of LPP. Randomized controlled trials are necessary to establish standard of care. Further studies should target the association of GLPL and other autoimmune phenomena. Moreover, research into the etiology will provide direction in understanding disease progression and outcome.

SAN DIEGO – In carefully selected patients with well-controlled inflammatory bowel disease (IBD), bariatric surgery results in sustained weight loss over a 2-year period, results from a retrospective study suggest.

“Obesity is increasing in patients with inflammatory bowel disease at a rate similar to that seen in the general population,” the study’s primary author, Nicholas P. McKenna, MD, said in an interview in advance of the annual Digestive Disease Week. “While bariatric surgery is a well-accepted therapy for obesity in patients without IBD, its use in patients with IBD is less well studied.”

For the current study, Dr. McKenna, a resident in the department of surgery at the Mayo Clinic in Rochester, Minn., and colleagues collected data on 33 patients who underwent bariatric surgery with a pre- or postoperative diagnosis of IBD across three academic centers between August 2006 and December 2017. They evaluated IBD characteristics and medications; postoperative complications; the need for future IBD-related surgery; and weight loss at 6, 12, and 24 months.

“Our hypothesis based on the existing literature was that bariatric surgery would be safe in carefully selected patients with IBD and result in sustained weight loss, so we were not surprised with these results,” Dr. McKenna said. “We were not sure if medication requirements would change after surgery as the literature is conflicted on this. We observed that most patients continued to require no immunosuppression for control of their IBD after surgery. Further, we did not observe that any patients required future surgery at the time of last follow-up for an IBD flare.”

He acknowledged certain limitations of the study, including its retrospective design. “Additionally, though it is a relatively large sample, compared to the existing literature on bariatric surgery in IBD, it is still only 33 patients. This limits the comparisons that can be performed between patients with ulcerative colitis and Crohn’s disease and between the operation choices.”

The study’s secondary author, Alaa Sada, MD, a surgery resident at Mayo, presented the findings at the meeting. The researchers reported having no financial disclosures.

[email protected]

SAN DIEGO – In carefully selected patients with well-controlled inflammatory bowel disease (IBD), bariatric surgery results in sustained weight loss over a 2-year period, results from a retrospective study suggest.

“Obesity is increasing in patients with inflammatory bowel disease at a rate similar to that seen in the general population,” the study’s primary author, Nicholas P. McKenna, MD, said in an interview in advance of the annual Digestive Disease Week. “While bariatric surgery is a well-accepted therapy for obesity in patients without IBD, its use in patients with IBD is less well studied.”

For the current study, Dr. McKenna, a resident in the department of surgery at the Mayo Clinic in Rochester, Minn., and colleagues collected data on 33 patients who underwent bariatric surgery with a pre- or postoperative diagnosis of IBD across three academic centers between August 2006 and December 2017. They evaluated IBD characteristics and medications; postoperative complications; the need for future IBD-related surgery; and weight loss at 6, 12, and 24 months.

“Our hypothesis based on the existing literature was that bariatric surgery would be safe in carefully selected patients with IBD and result in sustained weight loss, so we were not surprised with these results,” Dr. McKenna said. “We were not sure if medication requirements would change after surgery as the literature is conflicted on this. We observed that most patients continued to require no immunosuppression for control of their IBD after surgery. Further, we did not observe that any patients required future surgery at the time of last follow-up for an IBD flare.”

He acknowledged certain limitations of the study, including its retrospective design. “Additionally, though it is a relatively large sample, compared to the existing literature on bariatric surgery in IBD, it is still only 33 patients. This limits the comparisons that can be performed between patients with ulcerative colitis and Crohn’s disease and between the operation choices.”

The study’s secondary author, Alaa Sada, MD, a surgery resident at Mayo, presented the findings at the meeting. The researchers reported having no financial disclosures.

[email protected]

SAN DIEGO – In carefully selected patients with well-controlled inflammatory bowel disease (IBD), bariatric surgery results in sustained weight loss over a 2-year period, results from a retrospective study suggest.

“Obesity is increasing in patients with inflammatory bowel disease at a rate similar to that seen in the general population,” the study’s primary author, Nicholas P. McKenna, MD, said in an interview in advance of the annual Digestive Disease Week. “While bariatric surgery is a well-accepted therapy for obesity in patients without IBD, its use in patients with IBD is less well studied.”

For the current study, Dr. McKenna, a resident in the department of surgery at the Mayo Clinic in Rochester, Minn., and colleagues collected data on 33 patients who underwent bariatric surgery with a pre- or postoperative diagnosis of IBD across three academic centers between August 2006 and December 2017. They evaluated IBD characteristics and medications; postoperative complications; the need for future IBD-related surgery; and weight loss at 6, 12, and 24 months.

“Our hypothesis based on the existing literature was that bariatric surgery would be safe in carefully selected patients with IBD and result in sustained weight loss, so we were not surprised with these results,” Dr. McKenna said. “We were not sure if medication requirements would change after surgery as the literature is conflicted on this. We observed that most patients continued to require no immunosuppression for control of their IBD after surgery. Further, we did not observe that any patients required future surgery at the time of last follow-up for an IBD flare.”

He acknowledged certain limitations of the study, including its retrospective design. “Additionally, though it is a relatively large sample, compared to the existing literature on bariatric surgery in IBD, it is still only 33 patients. This limits the comparisons that can be performed between patients with ulcerative colitis and Crohn’s disease and between the operation choices.”

The study’s secondary author, Alaa Sada, MD, a surgery resident at Mayo, presented the findings at the meeting. The researchers reported having no financial disclosures.

[email protected]

NEW ORLEANS – About two thirds of men who chronically use opioids have low testosterone levels, based on a literature search of more than 50 randomized and observational studies that examined endocrine function in patients on chronic opioid therapy.

Hypocortisolism, seen in about 20% of the men in these studies, was among the other potentially significant deficiencies in endocrine function, Amir H. Zamanipoor Najafabadi, PhD, reported at the annual meeting of the Endocrine Society.

Dr. Najafabadi of Leiden University in the Netherlands, and Friso de Vries, PhD, analyzed the link between opioid use and changes in the gonadal axis. Most of the subjects in their study were men (J Endocr Soc. 2019. doi. 10.1210/js.2019-SUN-489).

While the data do not support firm conclusions on the health consequences of these endocrine observations, Dr. Najafabadi said that a prospective trial is needed to determine whether there is a potential benefit from screening patients on chronic opioids for potentially treatable endocrine deficiencies.

NEW ORLEANS – About two thirds of men who chronically use opioids have low testosterone levels, based on a literature search of more than 50 randomized and observational studies that examined endocrine function in patients on chronic opioid therapy.

Hypocortisolism, seen in about 20% of the men in these studies, was among the other potentially significant deficiencies in endocrine function, Amir H. Zamanipoor Najafabadi, PhD, reported at the annual meeting of the Endocrine Society.

Dr. Najafabadi of Leiden University in the Netherlands, and Friso de Vries, PhD, analyzed the link between opioid use and changes in the gonadal axis. Most of the subjects in their study were men (J Endocr Soc. 2019. doi. 10.1210/js.2019-SUN-489).

While the data do not support firm conclusions on the health consequences of these endocrine observations, Dr. Najafabadi said that a prospective trial is needed to determine whether there is a potential benefit from screening patients on chronic opioids for potentially treatable endocrine deficiencies.

NEW ORLEANS – About two thirds of men who chronically use opioids have low testosterone levels, based on a literature search of more than 50 randomized and observational studies that examined endocrine function in patients on chronic opioid therapy.

Hypocortisolism, seen in about 20% of the men in these studies, was among the other potentially significant deficiencies in endocrine function, Amir H. Zamanipoor Najafabadi, PhD, reported at the annual meeting of the Endocrine Society.

Dr. Najafabadi of Leiden University in the Netherlands, and Friso de Vries, PhD, analyzed the link between opioid use and changes in the gonadal axis. Most of the subjects in their study were men (J Endocr Soc. 2019. doi. 10.1210/js.2019-SUN-489).

While the data do not support firm conclusions on the health consequences of these endocrine observations, Dr. Najafabadi said that a prospective trial is needed to determine whether there is a potential benefit from screening patients on chronic opioids for potentially treatable endocrine deficiencies.

The Food and Drug Administration has reported that the higher postapproval mortality rates seen with Abiomed’s Impella RP System seem concentrated in a certain subgroup of patients only, according to a letter to health care providers.

The letter updates one from February regarding the observation of higher postapproval mortality rates with the temporary right heart pump.

This subgroup, which did not qualify for premarket clinical studies, was more likely to have been in cardiogenic shock for longer than 48 hours, experienced a cardiac arrest, or suffered a preimplant hypoxic or ischemic neurologic event prior to receiving the device, the FDA suggested in this new letter to health care providers. The 30-day survival rate in this subgroup within a postapproval study (PAS) was 10.7% (3 out of 28), while that among patients who would have qualified for the premarket clinical studies was 64.3% (9 of 14), according to the most recent interim results of that study. The rate among patients who would have qualified for premarket studies is similar to that seen among those premarket studies (73.4%); the overall 30-day survival rate in this PAS was 28.6%.

The FDA said that, based on these analyses, it still believes the benefits outweigh the risks when the Impella RP System is “used for the currently approved indication in appropriately selected patients.”

The FDA advises that health care providers review the device’s revised labeling, which now includes a checklist to help understand which patients could benefit the most. It also advises providers to promptly report any adverse events through MedWatch, which can help the FDA identify and understand the risks associated with the Impella RP System.

More information can be found in the FDA’s letter to health care providers, which is available on the FDA website.
 

[email protected]

The Food and Drug Administration has reported that the higher postapproval mortality rates seen with Abiomed’s Impella RP System seem concentrated in a certain subgroup of patients only, according to a letter to health care providers.

The letter updates one from February regarding the observation of higher postapproval mortality rates with the temporary right heart pump.

This subgroup, which did not qualify for premarket clinical studies, was more likely to have been in cardiogenic shock for longer than 48 hours, experienced a cardiac arrest, or suffered a preimplant hypoxic or ischemic neurologic event prior to receiving the device, the FDA suggested in this new letter to health care providers. The 30-day survival rate in this subgroup within a postapproval study (PAS) was 10.7% (3 out of 28), while that among patients who would have qualified for the premarket clinical studies was 64.3% (9 of 14), according to the most recent interim results of that study. The rate among patients who would have qualified for premarket studies is similar to that seen among those premarket studies (73.4%); the overall 30-day survival rate in this PAS was 28.6%.

The FDA said that, based on these analyses, it still believes the benefits outweigh the risks when the Impella RP System is “used for the currently approved indication in appropriately selected patients.”

The FDA advises that health care providers review the device’s revised labeling, which now includes a checklist to help understand which patients could benefit the most. It also advises providers to promptly report any adverse events through MedWatch, which can help the FDA identify and understand the risks associated with the Impella RP System.

More information can be found in the FDA’s letter to health care providers, which is available on the FDA website.
 

[email protected]

The Food and Drug Administration has reported that the higher postapproval mortality rates seen with Abiomed’s Impella RP System seem concentrated in a certain subgroup of patients only, according to a letter to health care providers.

The letter updates one from February regarding the observation of higher postapproval mortality rates with the temporary right heart pump.

This subgroup, which did not qualify for premarket clinical studies, was more likely to have been in cardiogenic shock for longer than 48 hours, experienced a cardiac arrest, or suffered a preimplant hypoxic or ischemic neurologic event prior to receiving the device, the FDA suggested in this new letter to health care providers. The 30-day survival rate in this subgroup within a postapproval study (PAS) was 10.7% (3 out of 28), while that among patients who would have qualified for the premarket clinical studies was 64.3% (9 of 14), according to the most recent interim results of that study. The rate among patients who would have qualified for premarket studies is similar to that seen among those premarket studies (73.4%); the overall 30-day survival rate in this PAS was 28.6%.

The FDA said that, based on these analyses, it still believes the benefits outweigh the risks when the Impella RP System is “used for the currently approved indication in appropriately selected patients.”

The FDA advises that health care providers review the device’s revised labeling, which now includes a checklist to help understand which patients could benefit the most. It also advises providers to promptly report any adverse events through MedWatch, which can help the FDA identify and understand the risks associated with the Impella RP System.

More information can be found in the FDA’s letter to health care providers, which is available on the FDA website.
 

[email protected]

CHICAGO – Prior authorizations for the delivery of care in dermatology may be increasing steeply, judging from the experience of one large academic dermatology practice.

“About the same number of patients were seen in 2018 as in 2016, but the number of prior authorizations required to serve those patients went up substantially,” reported Ryan P. Carlisle, a medical student who performed this analysis under the guidance of Aaron M. Secrest, MD, PhD, of the University of Utah, Salt Lake City.

Tracking of prior authorizations for the delivery of dermatologic care was initiated in 2016 at the University of Utah. By a number of measures, the burden of prior authorizations has been increasing steadily since that time, Mr. Carlisle said at the annual meeting of the Society for Investigative Dermatology.

As an example, one prior authorization was required for every 15 patient visits (6.7%) over a 30-day period in September 2016. In comparison, one prior authorization was required for every 9 patient visits (11.1%) in a comparable 30-day period in September 2018. Further, the number of clinic visits during this more recent period was 2.4% higher than in the earlier one (9,743 vs. 9,512), so the number of prior authorizations increased by 73.8% (1,088 vs. 626), Mr. Carlisle reported.

Two full-time staff and eight part-time staff at the University of Utah handle prior authorizations for 40 dermatologists and 10 nonphysician clinicians. The substantial unreimbursed costs incurred by this labor can be huge, he said. In one specific case, 81% of the reimbursed cost for a patient visit was consumed by seeking a prior authorization.

Of prior authorizations tracked at the University of Utah, 39.1% were for nonbiologic therapies, 21.6% were for excisions, 16% were for Moh’s surgery, 11% were for biologics, and the remainder was for an array of other procedures or therapies.

Of these, prior authorizations for biologics “were the most burdensome both in time and cost” on a per-visit basis, Mr. Carlisle reported.

The proportions of prior authorizations that were denied were relatively low. The highest proportion of denials was for nonbiologic medications (25%). The rate of denials for biologics over the study period was just 11%. Moreover, of denials that were appealed, 56% were granted.

Importantly, some prior authorizations were rarely denied. This includes a 0% denial rate for Moh’s surgery and a 1% denial rate for incisional procedures. Mr. Carlisle questioned whether the requirement for prior authorizations makes sense in these situations.

“Dermatology should partner with insurers to reduce unnecessary prior authorizations and appeals,” Mr. Carlisle suggested. It “is likely that these are affecting patient care” as well as ultimately, and perhaps unnecessarily, reducing reimbursement.

“The process to get prior authorizations completed and get patients their medications has just gotten to be too burdensome,” said Mr. Carlisle, summarizing the Utah experience.

SOURCE: Carlisle RP. SID 2019, Abstract 247.

CHICAGO – Prior authorizations for the delivery of care in dermatology may be increasing steeply, judging from the experience of one large academic dermatology practice.

“About the same number of patients were seen in 2018 as in 2016, but the number of prior authorizations required to serve those patients went up substantially,” reported Ryan P. Carlisle, a medical student who performed this analysis under the guidance of Aaron M. Secrest, MD, PhD, of the University of Utah, Salt Lake City.

Tracking of prior authorizations for the delivery of dermatologic care was initiated in 2016 at the University of Utah. By a number of measures, the burden of prior authorizations has been increasing steadily since that time, Mr. Carlisle said at the annual meeting of the Society for Investigative Dermatology.

As an example, one prior authorization was required for every 15 patient visits (6.7%) over a 30-day period in September 2016. In comparison, one prior authorization was required for every 9 patient visits (11.1%) in a comparable 30-day period in September 2018. Further, the number of clinic visits during this more recent period was 2.4% higher than in the earlier one (9,743 vs. 9,512), so the number of prior authorizations increased by 73.8% (1,088 vs. 626), Mr. Carlisle reported.

Two full-time staff and eight part-time staff at the University of Utah handle prior authorizations for 40 dermatologists and 10 nonphysician clinicians. The substantial unreimbursed costs incurred by this labor can be huge, he said. In one specific case, 81% of the reimbursed cost for a patient visit was consumed by seeking a prior authorization.

Of prior authorizations tracked at the University of Utah, 39.1% were for nonbiologic therapies, 21.6% were for excisions, 16% were for Moh’s surgery, 11% were for biologics, and the remainder was for an array of other procedures or therapies.

Of these, prior authorizations for biologics “were the most burdensome both in time and cost” on a per-visit basis, Mr. Carlisle reported.

The proportions of prior authorizations that were denied were relatively low. The highest proportion of denials was for nonbiologic medications (25%). The rate of denials for biologics over the study period was just 11%. Moreover, of denials that were appealed, 56% were granted.

Importantly, some prior authorizations were rarely denied. This includes a 0% denial rate for Moh’s surgery and a 1% denial rate for incisional procedures. Mr. Carlisle questioned whether the requirement for prior authorizations makes sense in these situations.

“Dermatology should partner with insurers to reduce unnecessary prior authorizations and appeals,” Mr. Carlisle suggested. It “is likely that these are affecting patient care” as well as ultimately, and perhaps unnecessarily, reducing reimbursement.

“The process to get prior authorizations completed and get patients their medications has just gotten to be too burdensome,” said Mr. Carlisle, summarizing the Utah experience.

SOURCE: Carlisle RP. SID 2019, Abstract 247.

CHICAGO – Prior authorizations for the delivery of care in dermatology may be increasing steeply, judging from the experience of one large academic dermatology practice.

“About the same number of patients were seen in 2018 as in 2016, but the number of prior authorizations required to serve those patients went up substantially,” reported Ryan P. Carlisle, a medical student who performed this analysis under the guidance of Aaron M. Secrest, MD, PhD, of the University of Utah, Salt Lake City.

Tracking of prior authorizations for the delivery of dermatologic care was initiated in 2016 at the University of Utah. By a number of measures, the burden of prior authorizations has been increasing steadily since that time, Mr. Carlisle said at the annual meeting of the Society for Investigative Dermatology.

As an example, one prior authorization was required for every 15 patient visits (6.7%) over a 30-day period in September 2016. In comparison, one prior authorization was required for every 9 patient visits (11.1%) in a comparable 30-day period in September 2018. Further, the number of clinic visits during this more recent period was 2.4% higher than in the earlier one (9,743 vs. 9,512), so the number of prior authorizations increased by 73.8% (1,088 vs. 626), Mr. Carlisle reported.

Two full-time staff and eight part-time staff at the University of Utah handle prior authorizations for 40 dermatologists and 10 nonphysician clinicians. The substantial unreimbursed costs incurred by this labor can be huge, he said. In one specific case, 81% of the reimbursed cost for a patient visit was consumed by seeking a prior authorization.

Of prior authorizations tracked at the University of Utah, 39.1% were for nonbiologic therapies, 21.6% were for excisions, 16% were for Moh’s surgery, 11% were for biologics, and the remainder was for an array of other procedures or therapies.

Of these, prior authorizations for biologics “were the most burdensome both in time and cost” on a per-visit basis, Mr. Carlisle reported.

The proportions of prior authorizations that were denied were relatively low. The highest proportion of denials was for nonbiologic medications (25%). The rate of denials for biologics over the study period was just 11%. Moreover, of denials that were appealed, 56% were granted.

Importantly, some prior authorizations were rarely denied. This includes a 0% denial rate for Moh’s surgery and a 1% denial rate for incisional procedures. Mr. Carlisle questioned whether the requirement for prior authorizations makes sense in these situations.

“Dermatology should partner with insurers to reduce unnecessary prior authorizations and appeals,” Mr. Carlisle suggested. It “is likely that these are affecting patient care” as well as ultimately, and perhaps unnecessarily, reducing reimbursement.

“The process to get prior authorizations completed and get patients their medications has just gotten to be too burdensome,” said Mr. Carlisle, summarizing the Utah experience.

SOURCE: Carlisle RP. SID 2019, Abstract 247.

WASHINGTON – A new pilot program addresses the social determinants of health in clinical practice through screening and referring patients with unmet social needs to the right resources.

Jennifer Reising/MDedge News

The program, called SHAPE (Social Health Alliance to Promote Equity), was designed to screen patients across multiple social categories. In-house patient navigators, some bilingual, were trained on how to work with diverse populations and were able to address unmet patient needs through referrals to individualized resources. Physicians could refer patients to the following local community partners:

• The Child Center of NY.
• The INN – serving hungry & homeless Long Islanders.
• Maurice A. Deane School of Law – Hofstra Law.
• The Gitenstein Institute for Health Law and Policy.

The legal partners provided free assistance to patience with legal needs.

“By implementing a program where you address the nonmedical social needs, you will actually improve the overall health of the patient. You can’t just address the biomedical needs of your patients, you need to understand their home environment, their background, and social situations they’re going through to keep them healthy,” said Jane Lindahl at the annual meeting of the Society of General Internal Medicine. Ms. Lindahl is a research assistant at Cohen Children’s Medical Center at Northwell Health in New York.

The SHAPE program was conducted at two internal medicine and pediatric primary care clinics at Northwell Health, a large academic hospital system in New York. It was originally created in the pediatric practice in August 2016 and expanded to the internal medicine practice in June 2018. A medicolegal partnership was created as part of the program in October 2018.

The patient population comprised low-income, racially ethnic, primarily Medicaid and uninsured individuals, including a high number of documented and undocumented immigrants. While 927 patients were screened, 590 screened positive for social determinants of health (SDOH). Of those 590 patients, 190 patients connected with patient navigators for intake and accepted initial assistance and 74 patients were connected to resources.

Screening was based on patients’ completion of a one-page SDOH form in the waiting room of their physician’s office on the same day of their annual visit. There were 15 categories of social needs identified on the screen.

After the screening, the results were discussed with the patients and the necessary referrals were determined. The screening indicated that the largest needs for the patients were health/dental insurance (cited by 296 people), education (cited by 269 people), and health literacy (cited by 225 patients).

Those who had emergent social needs were referred to on-site social workers and providers to address such needs. The emergent social needs included being a victim of domestic violence, being homeless, having an imminent eviction, and having imminent deportation.

Those patients with nonemergent social needs received referral and follow-up processes within 48 hours.

After a referral was made, the patient navigator followed up every 2 weeks with the patient to check on the status of the referral and social needs. After this period, a final phone interview was conducted to get feedback on the patient’s experience and SDOH status.

Ms. Lindahl had no financial conflicts of interest to disclose. The program was funded by Robert Wood Johnson Foundation Clinical Scholars Grant, Health Leads, Collaborative to Advance Social Health Integration, N.Y. State Delivery System Reform Incentive Program, and United Hospital Foundation.

WASHINGTON – A new pilot program addresses the social determinants of health in clinical practice through screening and referring patients with unmet social needs to the right resources.

Jennifer Reising/MDedge News

The program, called SHAPE (Social Health Alliance to Promote Equity), was designed to screen patients across multiple social categories. In-house patient navigators, some bilingual, were trained on how to work with diverse populations and were able to address unmet patient needs through referrals to individualized resources. Physicians could refer patients to the following local community partners:

• The Child Center of NY.
• The INN – serving hungry & homeless Long Islanders.
• Maurice A. Deane School of Law – Hofstra Law.
• The Gitenstein Institute for Health Law and Policy.

The legal partners provided free assistance to patience with legal needs.

“By implementing a program where you address the nonmedical social needs, you will actually improve the overall health of the patient. You can’t just address the biomedical needs of your patients, you need to understand their home environment, their background, and social situations they’re going through to keep them healthy,” said Jane Lindahl at the annual meeting of the Society of General Internal Medicine. Ms. Lindahl is a research assistant at Cohen Children’s Medical Center at Northwell Health in New York.

The SHAPE program was conducted at two internal medicine and pediatric primary care clinics at Northwell Health, a large academic hospital system in New York. It was originally created in the pediatric practice in August 2016 and expanded to the internal medicine practice in June 2018. A medicolegal partnership was created as part of the program in October 2018.

The patient population comprised low-income, racially ethnic, primarily Medicaid and uninsured individuals, including a high number of documented and undocumented immigrants. While 927 patients were screened, 590 screened positive for social determinants of health (SDOH). Of those 590 patients, 190 patients connected with patient navigators for intake and accepted initial assistance and 74 patients were connected to resources.

Screening was based on patients’ completion of a one-page SDOH form in the waiting room of their physician’s office on the same day of their annual visit. There were 15 categories of social needs identified on the screen.

After the screening, the results were discussed with the patients and the necessary referrals were determined. The screening indicated that the largest needs for the patients were health/dental insurance (cited by 296 people), education (cited by 269 people), and health literacy (cited by 225 patients).

Those who had emergent social needs were referred to on-site social workers and providers to address such needs. The emergent social needs included being a victim of domestic violence, being homeless, having an imminent eviction, and having imminent deportation.

Those patients with nonemergent social needs received referral and follow-up processes within 48 hours.

After a referral was made, the patient navigator followed up every 2 weeks with the patient to check on the status of the referral and social needs. After this period, a final phone interview was conducted to get feedback on the patient’s experience and SDOH status.

Ms. Lindahl had no financial conflicts of interest to disclose. The program was funded by Robert Wood Johnson Foundation Clinical Scholars Grant, Health Leads, Collaborative to Advance Social Health Integration, N.Y. State Delivery System Reform Incentive Program, and United Hospital Foundation.

WASHINGTON – A new pilot program addresses the social determinants of health in clinical practice through screening and referring patients with unmet social needs to the right resources.

Jennifer Reising/MDedge News

The program, called SHAPE (Social Health Alliance to Promote Equity), was designed to screen patients across multiple social categories. In-house patient navigators, some bilingual, were trained on how to work with diverse populations and were able to address unmet patient needs through referrals to individualized resources. Physicians could refer patients to the following local community partners:

• The Child Center of NY.
• The INN – serving hungry & homeless Long Islanders.
• Maurice A. Deane School of Law – Hofstra Law.
• The Gitenstein Institute for Health Law and Policy.

The legal partners provided free assistance to patience with legal needs.

“By implementing a program where you address the nonmedical social needs, you will actually improve the overall health of the patient. You can’t just address the biomedical needs of your patients, you need to understand their home environment, their background, and social situations they’re going through to keep them healthy,” said Jane Lindahl at the annual meeting of the Society of General Internal Medicine. Ms. Lindahl is a research assistant at Cohen Children’s Medical Center at Northwell Health in New York.

The SHAPE program was conducted at two internal medicine and pediatric primary care clinics at Northwell Health, a large academic hospital system in New York. It was originally created in the pediatric practice in August 2016 and expanded to the internal medicine practice in June 2018. A medicolegal partnership was created as part of the program in October 2018.

The patient population comprised low-income, racially ethnic, primarily Medicaid and uninsured individuals, including a high number of documented and undocumented immigrants. While 927 patients were screened, 590 screened positive for social determinants of health (SDOH). Of those 590 patients, 190 patients connected with patient navigators for intake and accepted initial assistance and 74 patients were connected to resources.

Screening was based on patients’ completion of a one-page SDOH form in the waiting room of their physician’s office on the same day of their annual visit. There were 15 categories of social needs identified on the screen.

After the screening, the results were discussed with the patients and the necessary referrals were determined. The screening indicated that the largest needs for the patients were health/dental insurance (cited by 296 people), education (cited by 269 people), and health literacy (cited by 225 patients).

Those who had emergent social needs were referred to on-site social workers and providers to address such needs. The emergent social needs included being a victim of domestic violence, being homeless, having an imminent eviction, and having imminent deportation.

Those patients with nonemergent social needs received referral and follow-up processes within 48 hours.

After a referral was made, the patient navigator followed up every 2 weeks with the patient to check on the status of the referral and social needs. After this period, a final phone interview was conducted to get feedback on the patient’s experience and SDOH status.

Ms. Lindahl had no financial conflicts of interest to disclose. The program was funded by Robert Wood Johnson Foundation Clinical Scholars Grant, Health Leads, Collaborative to Advance Social Health Integration, N.Y. State Delivery System Reform Incentive Program, and United Hospital Foundation.

To the Editor:

A 30-year-old man with no notable medical history presented to the dermatology clinic with multiple subcutaneous nodules on the forehead of 5 years’ duration. He reported no history of forehead trauma or manipulation of the lesions, and there was no accompanying pruritis, pain, erythema, or purulent discharge. There was no family history of skin or gastrointestinal tract tumors. On physical examination, the patient had 5 firm, flesh-colored to yellow nodules measuring approximately 0.2 to 1.5 cm in diameter without central punctae scattered over the central forehead (Figure 1). Due to cosmetic concerns, the patient elected to pursue surgical excision of the lesions, which occurred over several office visits. During surgical excision, the lesions were found to be smooth, encapsulated, and mobile, and they were excised without surgical complication. Histopathologic examination showed subcutaneous cysts lined by squamous epithelium with associated sebaceous glands (Figure 2A) and hair follicles in the cyst lumen (Figure 2B). These findings confirmed the diagnosis of multiple subcutaneous dermoid cysts.

Dermoid cysts are relatively uncommon, benign tumors consisting of tissue derived from ectodermal and mesodermal germ cell layers. Dermoid cysts may be distinguished from teratomas, which may contain tissues derived from all 3 germ cell layers and typically consist of types of tissues foreign to the site of origin, such as dental, thyroid, gastrointestinal, or neural tissue.^1,2 The majority of dermoid cysts are congenitally developed along the lines of embryologic fusion due to an error in the division of the ectoderm and mesoderm^3,4; however, some dermoid cysts may be acquired from epidermal elements being traumatically implanted into the dermis.⁵

Our patient’s presentation with multiple dermoid cysts was atypical, as dermoid cysts are almost always solitary tumors. A similar case was reported in a 41-year-old man who developed multiple dermoid cysts on the forehead over a 20-year period.This patient also was otherwise healthy, denied prior trauma to the forehead, and reported no family history of skin or gastrointestinal tract tumors.⁵

Another unusual feature in our case was the location of the dermoid cysts on the central forehead. The most common location for dermoid cysts is the lateral third of the eyebrows (47%–70% of cases).^1,4,6-10 These cysts occur because of sequestration of the surface ectoderm during fusion along the naso-optic groove.² Dermoid cysts also have been noted in other anatomical areas such as the scalp, nose, anterior neck, and trunk.⁶

Dermoid cysts tend to be small, round, smooth, and slowly growing until sudden enlargement prompts surgical evaluation.^4,6 During surgical excision, they often are fixed to the underlying bone but also may be freely mobile, as in our patient.⁶ Histopathologic examination reveals a stratified squamous epithelium with associated adnexal structures such as sebaceous glands or hair follicles.¹ Smooth muscle fibers, prominent vascular stroma, small nerves, and collagen and elastic fibers also may be found within the lumen of dermoid cysts.²

In some cases, dermoid cysts may be invasive and carry the risk of bony erosion, intracranial extension, osteomyelitis, meningitis, or cerebral abscess. Imaging studies sometimes are needed to rule out intracranial or intraspinal extension, particularly for midline dermoid cysts.⁶ The standard of treatment for dermoid cysts is surgical excision and complete enucleation without disruption of the cyst wall; however, invasive dermoid cysts may require endoscopic excision, orbitotomy, or craniotomy.^4,6

To the Editor:

A 30-year-old man with no notable medical history presented to the dermatology clinic with multiple subcutaneous nodules on the forehead of 5 years’ duration. He reported no history of forehead trauma or manipulation of the lesions, and there was no accompanying pruritis, pain, erythema, or purulent discharge. There was no family history of skin or gastrointestinal tract tumors. On physical examination, the patient had 5 firm, flesh-colored to yellow nodules measuring approximately 0.2 to 1.5 cm in diameter without central punctae scattered over the central forehead (Figure 1). Due to cosmetic concerns, the patient elected to pursue surgical excision of the lesions, which occurred over several office visits. During surgical excision, the lesions were found to be smooth, encapsulated, and mobile, and they were excised without surgical complication. Histopathologic examination showed subcutaneous cysts lined by squamous epithelium with associated sebaceous glands (Figure 2A) and hair follicles in the cyst lumen (Figure 2B). These findings confirmed the diagnosis of multiple subcutaneous dermoid cysts.

Dermoid cysts are relatively uncommon, benign tumors consisting of tissue derived from ectodermal and mesodermal germ cell layers. Dermoid cysts may be distinguished from teratomas, which may contain tissues derived from all 3 germ cell layers and typically consist of types of tissues foreign to the site of origin, such as dental, thyroid, gastrointestinal, or neural tissue.^1,2 The majority of dermoid cysts are congenitally developed along the lines of embryologic fusion due to an error in the division of the ectoderm and mesoderm^3,4; however, some dermoid cysts may be acquired from epidermal elements being traumatically implanted into the dermis.⁵

Our patient’s presentation with multiple dermoid cysts was atypical, as dermoid cysts are almost always solitary tumors. A similar case was reported in a 41-year-old man who developed multiple dermoid cysts on the forehead over a 20-year period.This patient also was otherwise healthy, denied prior trauma to the forehead, and reported no family history of skin or gastrointestinal tract tumors.⁵

Another unusual feature in our case was the location of the dermoid cysts on the central forehead. The most common location for dermoid cysts is the lateral third of the eyebrows (47%–70% of cases).^1,4,6-10 These cysts occur because of sequestration of the surface ectoderm during fusion along the naso-optic groove.² Dermoid cysts also have been noted in other anatomical areas such as the scalp, nose, anterior neck, and trunk.⁶

Dermoid cysts tend to be small, round, smooth, and slowly growing until sudden enlargement prompts surgical evaluation.^4,6 During surgical excision, they often are fixed to the underlying bone but also may be freely mobile, as in our patient.⁶ Histopathologic examination reveals a stratified squamous epithelium with associated adnexal structures such as sebaceous glands or hair follicles.¹ Smooth muscle fibers, prominent vascular stroma, small nerves, and collagen and elastic fibers also may be found within the lumen of dermoid cysts.²

In some cases, dermoid cysts may be invasive and carry the risk of bony erosion, intracranial extension, osteomyelitis, meningitis, or cerebral abscess. Imaging studies sometimes are needed to rule out intracranial or intraspinal extension, particularly for midline dermoid cysts.⁶ The standard of treatment for dermoid cysts is surgical excision and complete enucleation without disruption of the cyst wall; however, invasive dermoid cysts may require endoscopic excision, orbitotomy, or craniotomy.^4,6

To the Editor:

A 30-year-old man with no notable medical history presented to the dermatology clinic with multiple subcutaneous nodules on the forehead of 5 years’ duration. He reported no history of forehead trauma or manipulation of the lesions, and there was no accompanying pruritis, pain, erythema, or purulent discharge. There was no family history of skin or gastrointestinal tract tumors. On physical examination, the patient had 5 firm, flesh-colored to yellow nodules measuring approximately 0.2 to 1.5 cm in diameter without central punctae scattered over the central forehead (Figure 1). Due to cosmetic concerns, the patient elected to pursue surgical excision of the lesions, which occurred over several office visits. During surgical excision, the lesions were found to be smooth, encapsulated, and mobile, and they were excised without surgical complication. Histopathologic examination showed subcutaneous cysts lined by squamous epithelium with associated sebaceous glands (Figure 2A) and hair follicles in the cyst lumen (Figure 2B). These findings confirmed the diagnosis of multiple subcutaneous dermoid cysts.

Dermoid cysts are relatively uncommon, benign tumors consisting of tissue derived from ectodermal and mesodermal germ cell layers. Dermoid cysts may be distinguished from teratomas, which may contain tissues derived from all 3 germ cell layers and typically consist of types of tissues foreign to the site of origin, such as dental, thyroid, gastrointestinal, or neural tissue.^1,2 The majority of dermoid cysts are congenitally developed along the lines of embryologic fusion due to an error in the division of the ectoderm and mesoderm^3,4; however, some dermoid cysts may be acquired from epidermal elements being traumatically implanted into the dermis.⁵

Our patient’s presentation with multiple dermoid cysts was atypical, as dermoid cysts are almost always solitary tumors. A similar case was reported in a 41-year-old man who developed multiple dermoid cysts on the forehead over a 20-year period.This patient also was otherwise healthy, denied prior trauma to the forehead, and reported no family history of skin or gastrointestinal tract tumors.⁵

Another unusual feature in our case was the location of the dermoid cysts on the central forehead. The most common location for dermoid cysts is the lateral third of the eyebrows (47%–70% of cases).^1,4,6-10 These cysts occur because of sequestration of the surface ectoderm during fusion along the naso-optic groove.² Dermoid cysts also have been noted in other anatomical areas such as the scalp, nose, anterior neck, and trunk.⁶

Dermoid cysts tend to be small, round, smooth, and slowly growing until sudden enlargement prompts surgical evaluation.^4,6 During surgical excision, they often are fixed to the underlying bone but also may be freely mobile, as in our patient.⁶ Histopathologic examination reveals a stratified squamous epithelium with associated adnexal structures such as sebaceous glands or hair follicles.¹ Smooth muscle fibers, prominent vascular stroma, small nerves, and collagen and elastic fibers also may be found within the lumen of dermoid cysts.²

In some cases, dermoid cysts may be invasive and carry the risk of bony erosion, intracranial extension, osteomyelitis, meningitis, or cerebral abscess. Imaging studies sometimes are needed to rule out intracranial or intraspinal extension, particularly for midline dermoid cysts.⁶ The standard of treatment for dermoid cysts is surgical excision and complete enucleation without disruption of the cyst wall; however, invasive dermoid cysts may require endoscopic excision, orbitotomy, or craniotomy.^4,6