Many patients with cancer, as well as doctors in fields other than oncology, are unaware of just how much progress has been made in recent years in the treatment of cancer, particularly with immunotherapy.

This is the main finding from two studies presented at the 2021 European Society for Medical Oncology Congress.

The survey of patients found that most don’t understand how immunotherapy works, and the survey of doctors found that many working outside of the cancer field are using information on survival that is wildly out of date.

When a patient is first told they have cancer, counseling is usually done by a surgeon or general medical doctor and not an oncologist, said Conleth Murphy, MD, of Bon Secours Hospital Cork, Ireland, and coauthor of the second study.

Noncancer doctors often grossly underestimate patients’ chances of survival, Dr. Murphy’s study found. This suggests that doctors who practice outside of cancer care may be working with the same information they learned in medical school, he said.

“These patients must be spared the traumatic effects of being handed a death sentence that no longer reflects the current reality,” Dr. Murphy said.

After receiving a diagnosis of cancer, “patients often immediately have pressing questions about what it means for their future,” he noted. A common question is: “How long do I have left?”

Nononcologists should refrain from answering patients’ questions with numbers, Dr. Murphy said.

Family doctors are likely to be influenced by the experience they have had with specific cancer patients in their practice, said Cyril Bonin, MD, a general practitioner in Usson-du-Poitou, France, who has 900 patients in his practice.

He sees about 10 patients with a new diagnosis of cancer each year. In addition, about 50 of his patients are in active treatment for cancer or have finished treatment and are considered cancer survivors.

“It is not entirely realistic for us to expect practitioners who deal with hundreds of different diseases to keep up with every facet of a rapidly changing oncology landscape,” said Marco Donia, MD, an expert in immunotherapy from the University of Copenhagen.

That landscape has changed dramatically in recent years, particularly since immunotherapy was added to the arsenal. Immunotherapy is a way to fine-tune your immune system to fight cancer.

For example, in the past, patients with metastatic melanoma would have an average survival of about 1 year. But now, some patients who have responded to immunotherapy are still alive 10 years later.
 

Findings from the patient survey

It is important that patients stay well informed because immunotherapy is a “complex treatment that is too often mistaken for a miracle cure,” said Paris Kosmidis, MD, the co-author of the patient survey.

“The more patients know about it, the better the communication with their medical team and thus the better their outcomes are likely to be,” said Dr. Kosmidis, who is co-founder and chief medical officer of CareAcross, an online service that provides personalized education for cancer patients

The survey was of 5,589 patients with cancer who were recruited from CareAcross clients from the United Kingdom, France, Italy, Spain, and Germany.

The survey asked them about how immunotherapy works, what it costs, and its side effects.

Almost half responded “not sure/do not know,” but about a third correctly answered that immunotherapy “activates the immune system to kill cancer cells.”

Similarly, more than half thought that immunotherapy started working right away, while only 20% correctly answered that it takes several weeks to become effective.

“This is important because patients need to start their therapy with realistic expectations, for example to avoid disappointment when their symptoms take some time to disappear,” Dr. Kosmidis said.

A small group of 24 patients with lung cancer who had been treated with immunotherapy got many correct answers, but they overestimated the intensity of side effects, compared with other therapies.

“Well-informed patients who know what to expect can do 90% of the job of preventing side effects from becoming severe by having them treated early,” said Dr. Donia, of the University of Copenhagen.

Most cancer patients were also unaware of the cost of immunotherapy, which can exceed $100,000 a year, Dr. Kosmidis said.
 

Results of the doctor survey

The other survey presented at the meeting looked at how much doctors know about survival for 12 of the most common cancers.

Dr. Murphy and colleagues asked 301 noncancer doctors and 46 cancer specialists to estimate the percentage of patients who could be expected to live for 5 years after diagnosis (a measure known as the 5-year survival rate).

Answers from the two groups were compared and graded according to cancer survival statistics from the National Cancer Registry of Ireland.

Both groups of doctors had a hard time estimating the survival of common cancers.

Nononcologists accurately predicted 5-year survival for just two of the cancer types, while the cancer specialists got it right for four cancer types.

However, the noncancer doctors had a more pessimistic outlook on cancer survival generally and severely underestimated the chances of survival in specific cancers, particularly stage IV breast cancer. The survival for this cancer has “evolved considerably over time and now reaches 40% in Ireland,” Dr. Murphy pointed out.

“These results are in line with what we had expected because most physicians’ knowledge of oncology dates back to whatever education they received during their years of training, so their perceptions of cancer prognosis are likely to lag behind the major survival gains achieved in the recent past,” Dr. Murphy said.

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

Many patients with cancer, as well as doctors in fields other than oncology, are unaware of just how much progress has been made in recent years in the treatment of cancer, particularly with immunotherapy.

This is the main finding from two studies presented at the 2021 European Society for Medical Oncology Congress.

The survey of patients found that most don’t understand how immunotherapy works, and the survey of doctors found that many working outside of the cancer field are using information on survival that is wildly out of date.

When a patient is first told they have cancer, counseling is usually done by a surgeon or general medical doctor and not an oncologist, said Conleth Murphy, MD, of Bon Secours Hospital Cork, Ireland, and coauthor of the second study.

Noncancer doctors often grossly underestimate patients’ chances of survival, Dr. Murphy’s study found. This suggests that doctors who practice outside of cancer care may be working with the same information they learned in medical school, he said.

“These patients must be spared the traumatic effects of being handed a death sentence that no longer reflects the current reality,” Dr. Murphy said.

After receiving a diagnosis of cancer, “patients often immediately have pressing questions about what it means for their future,” he noted. A common question is: “How long do I have left?”

Nononcologists should refrain from answering patients’ questions with numbers, Dr. Murphy said.

Family doctors are likely to be influenced by the experience they have had with specific cancer patients in their practice, said Cyril Bonin, MD, a general practitioner in Usson-du-Poitou, France, who has 900 patients in his practice.

He sees about 10 patients with a new diagnosis of cancer each year. In addition, about 50 of his patients are in active treatment for cancer or have finished treatment and are considered cancer survivors.

“It is not entirely realistic for us to expect practitioners who deal with hundreds of different diseases to keep up with every facet of a rapidly changing oncology landscape,” said Marco Donia, MD, an expert in immunotherapy from the University of Copenhagen.

That landscape has changed dramatically in recent years, particularly since immunotherapy was added to the arsenal. Immunotherapy is a way to fine-tune your immune system to fight cancer.

For example, in the past, patients with metastatic melanoma would have an average survival of about 1 year. But now, some patients who have responded to immunotherapy are still alive 10 years later.
 

Findings from the patient survey

It is important that patients stay well informed because immunotherapy is a “complex treatment that is too often mistaken for a miracle cure,” said Paris Kosmidis, MD, the co-author of the patient survey.

“The more patients know about it, the better the communication with their medical team and thus the better their outcomes are likely to be,” said Dr. Kosmidis, who is co-founder and chief medical officer of CareAcross, an online service that provides personalized education for cancer patients

The survey was of 5,589 patients with cancer who were recruited from CareAcross clients from the United Kingdom, France, Italy, Spain, and Germany.

The survey asked them about how immunotherapy works, what it costs, and its side effects.

Almost half responded “not sure/do not know,” but about a third correctly answered that immunotherapy “activates the immune system to kill cancer cells.”

Similarly, more than half thought that immunotherapy started working right away, while only 20% correctly answered that it takes several weeks to become effective.

“This is important because patients need to start their therapy with realistic expectations, for example to avoid disappointment when their symptoms take some time to disappear,” Dr. Kosmidis said.

A small group of 24 patients with lung cancer who had been treated with immunotherapy got many correct answers, but they overestimated the intensity of side effects, compared with other therapies.

“Well-informed patients who know what to expect can do 90% of the job of preventing side effects from becoming severe by having them treated early,” said Dr. Donia, of the University of Copenhagen.

Most cancer patients were also unaware of the cost of immunotherapy, which can exceed $100,000 a year, Dr. Kosmidis said.
 

Results of the doctor survey

The other survey presented at the meeting looked at how much doctors know about survival for 12 of the most common cancers.

Dr. Murphy and colleagues asked 301 noncancer doctors and 46 cancer specialists to estimate the percentage of patients who could be expected to live for 5 years after diagnosis (a measure known as the 5-year survival rate).

Answers from the two groups were compared and graded according to cancer survival statistics from the National Cancer Registry of Ireland.

Both groups of doctors had a hard time estimating the survival of common cancers.

Nononcologists accurately predicted 5-year survival for just two of the cancer types, while the cancer specialists got it right for four cancer types.

However, the noncancer doctors had a more pessimistic outlook on cancer survival generally and severely underestimated the chances of survival in specific cancers, particularly stage IV breast cancer. The survival for this cancer has “evolved considerably over time and now reaches 40% in Ireland,” Dr. Murphy pointed out.

“These results are in line with what we had expected because most physicians’ knowledge of oncology dates back to whatever education they received during their years of training, so their perceptions of cancer prognosis are likely to lag behind the major survival gains achieved in the recent past,” Dr. Murphy said.

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

Many patients with cancer, as well as doctors in fields other than oncology, are unaware of just how much progress has been made in recent years in the treatment of cancer, particularly with immunotherapy.

This is the main finding from two studies presented at the 2021 European Society for Medical Oncology Congress.

The survey of patients found that most don’t understand how immunotherapy works, and the survey of doctors found that many working outside of the cancer field are using information on survival that is wildly out of date.

When a patient is first told they have cancer, counseling is usually done by a surgeon or general medical doctor and not an oncologist, said Conleth Murphy, MD, of Bon Secours Hospital Cork, Ireland, and coauthor of the second study.

Noncancer doctors often grossly underestimate patients’ chances of survival, Dr. Murphy’s study found. This suggests that doctors who practice outside of cancer care may be working with the same information they learned in medical school, he said.

“These patients must be spared the traumatic effects of being handed a death sentence that no longer reflects the current reality,” Dr. Murphy said.

After receiving a diagnosis of cancer, “patients often immediately have pressing questions about what it means for their future,” he noted. A common question is: “How long do I have left?”

Nononcologists should refrain from answering patients’ questions with numbers, Dr. Murphy said.

Family doctors are likely to be influenced by the experience they have had with specific cancer patients in their practice, said Cyril Bonin, MD, a general practitioner in Usson-du-Poitou, France, who has 900 patients in his practice.

He sees about 10 patients with a new diagnosis of cancer each year. In addition, about 50 of his patients are in active treatment for cancer or have finished treatment and are considered cancer survivors.

“It is not entirely realistic for us to expect practitioners who deal with hundreds of different diseases to keep up with every facet of a rapidly changing oncology landscape,” said Marco Donia, MD, an expert in immunotherapy from the University of Copenhagen.

That landscape has changed dramatically in recent years, particularly since immunotherapy was added to the arsenal. Immunotherapy is a way to fine-tune your immune system to fight cancer.

For example, in the past, patients with metastatic melanoma would have an average survival of about 1 year. But now, some patients who have responded to immunotherapy are still alive 10 years later.
 

Findings from the patient survey

It is important that patients stay well informed because immunotherapy is a “complex treatment that is too often mistaken for a miracle cure,” said Paris Kosmidis, MD, the co-author of the patient survey.

“The more patients know about it, the better the communication with their medical team and thus the better their outcomes are likely to be,” said Dr. Kosmidis, who is co-founder and chief medical officer of CareAcross, an online service that provides personalized education for cancer patients

The survey was of 5,589 patients with cancer who were recruited from CareAcross clients from the United Kingdom, France, Italy, Spain, and Germany.

The survey asked them about how immunotherapy works, what it costs, and its side effects.

Almost half responded “not sure/do not know,” but about a third correctly answered that immunotherapy “activates the immune system to kill cancer cells.”

Similarly, more than half thought that immunotherapy started working right away, while only 20% correctly answered that it takes several weeks to become effective.

“This is important because patients need to start their therapy with realistic expectations, for example to avoid disappointment when their symptoms take some time to disappear,” Dr. Kosmidis said.

A small group of 24 patients with lung cancer who had been treated with immunotherapy got many correct answers, but they overestimated the intensity of side effects, compared with other therapies.

“Well-informed patients who know what to expect can do 90% of the job of preventing side effects from becoming severe by having them treated early,” said Dr. Donia, of the University of Copenhagen.

Most cancer patients were also unaware of the cost of immunotherapy, which can exceed $100,000 a year, Dr. Kosmidis said.
 

Results of the doctor survey

The other survey presented at the meeting looked at how much doctors know about survival for 12 of the most common cancers.

Dr. Murphy and colleagues asked 301 noncancer doctors and 46 cancer specialists to estimate the percentage of patients who could be expected to live for 5 years after diagnosis (a measure known as the 5-year survival rate).

Answers from the two groups were compared and graded according to cancer survival statistics from the National Cancer Registry of Ireland.

Both groups of doctors had a hard time estimating the survival of common cancers.

Nononcologists accurately predicted 5-year survival for just two of the cancer types, while the cancer specialists got it right for four cancer types.

However, the noncancer doctors had a more pessimistic outlook on cancer survival generally and severely underestimated the chances of survival in specific cancers, particularly stage IV breast cancer. The survival for this cancer has “evolved considerably over time and now reaches 40% in Ireland,” Dr. Murphy pointed out.

“These results are in line with what we had expected because most physicians’ knowledge of oncology dates back to whatever education they received during their years of training, so their perceptions of cancer prognosis are likely to lag behind the major survival gains achieved in the recent past,” Dr. Murphy said.

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

The overall survival benefit with durvalumab plus etoposide and cisplatin/carboplatin versus EP alone for the first-line treatment of extensive-stage small cell lung cancer (ES-SCLC) as demonstrated in the phase 3 CASPIAN trial was sustained beyond 3 years, according to a planned exploratory analysis.

The durable overall survival (OS) benefit and the well-tolerated safety profile of the durvalumab with EP therapy further establishes the combination as the standard of care for the first-line treatment of ES-SCLC, Luis Paz-Ares, MD, reported at the 2021 European Society for Medical Oncology Congress on Sept. 18 (abstract LBA61).

At 3 years, there is more than three times the survival in patients with durvalumab and EP versus EP, and at the same time, the adverse-event profile continues to be favorable,” said Dr. Paz-Ares of Universidad Complutense & Ciberonc, Madrid.

This is the longest follow-up reported to date for a phase 3 trial of a programmed death–ligand 1 inhibitor and EP in this setting, he said.

The CASPIAN trial included 805 treatment-naive patients with ES-SCLC who were randomized 1:1:1 to receive 1,500 mg of durvalumab with EP every 3 weeks, 1,500 mg of durvalumab at 75 mg of tremelimumab and EP every 3 weeks, or EP alone. Patients in the durvalumab arms received four cycles of treatment followed by maintenance durvalumab, and those in the EP-only arm received up to six cycles of EP.

Primary outcomes data from the trial showed a significant overall survival benefit with durvalumab and EP versus EP alone (hazard ratio, 0.73), as did a subsequent analysis after a median follow-up of 25.1 mo (HR, 0.75).

Durvalumab with tremelimumab and EP numerically improved overall survival versus EP (HR, 0.82), but did not reach statistical significance.

At median follow up of 39.4 months, the durvalumab and EP combination showed sustained improvement in overall survival versus EP alone (HR, 0.71).

Median overall survival was 12.9 versus 10.5 months. OS was 22.9% versus 13.9% at 24 months, and 17.6% versus 5.8% at 36 months with durvalumab with EP versus EP, respectively, Dr. Paz-Ares said.

Durvalumab plus tremelimumab plus EP continued to numerically improve overall survival, compared with EP alone (HR, 0.81); median OS in that arm was 10.4 months, and 15.3% of patients were alive at 36 months, he noted.

Serious adverse events occurred in 32.5%, 47.4%, and 36.5% of patients in the durvalumab with EP, durvalumab plus tremelimumab plus EP, and EP arms respectively, and adverse events leading to death occurred in 5.3%, 10.9%, and 6.0%, respectively.

The findings are “really encouraging and unprecedented, frankly,” said session chair Alfredo Addeo, MD, of University Hospital, Geneva.

“They are setting the bar for competitors,” he said, referencing the IMpower 133 trial looking at atezolizumab with chemotherapy in ES-SCLC.

The CASPIAN study was funded by AstraZeneca. Dr. Paz-Ares reported relationships with multiple pharmaceutical companies.

[email protected]

The overall survival benefit with durvalumab plus etoposide and cisplatin/carboplatin versus EP alone for the first-line treatment of extensive-stage small cell lung cancer (ES-SCLC) as demonstrated in the phase 3 CASPIAN trial was sustained beyond 3 years, according to a planned exploratory analysis.

The durable overall survival (OS) benefit and the well-tolerated safety profile of the durvalumab with EP therapy further establishes the combination as the standard of care for the first-line treatment of ES-SCLC, Luis Paz-Ares, MD, reported at the 2021 European Society for Medical Oncology Congress on Sept. 18 (abstract LBA61).

At 3 years, there is more than three times the survival in patients with durvalumab and EP versus EP, and at the same time, the adverse-event profile continues to be favorable,” said Dr. Paz-Ares of Universidad Complutense & Ciberonc, Madrid.

This is the longest follow-up reported to date for a phase 3 trial of a programmed death–ligand 1 inhibitor and EP in this setting, he said.

The CASPIAN trial included 805 treatment-naive patients with ES-SCLC who were randomized 1:1:1 to receive 1,500 mg of durvalumab with EP every 3 weeks, 1,500 mg of durvalumab at 75 mg of tremelimumab and EP every 3 weeks, or EP alone. Patients in the durvalumab arms received four cycles of treatment followed by maintenance durvalumab, and those in the EP-only arm received up to six cycles of EP.

Primary outcomes data from the trial showed a significant overall survival benefit with durvalumab and EP versus EP alone (hazard ratio, 0.73), as did a subsequent analysis after a median follow-up of 25.1 mo (HR, 0.75).

Durvalumab with tremelimumab and EP numerically improved overall survival versus EP (HR, 0.82), but did not reach statistical significance.

At median follow up of 39.4 months, the durvalumab and EP combination showed sustained improvement in overall survival versus EP alone (HR, 0.71).

Median overall survival was 12.9 versus 10.5 months. OS was 22.9% versus 13.9% at 24 months, and 17.6% versus 5.8% at 36 months with durvalumab with EP versus EP, respectively, Dr. Paz-Ares said.

Durvalumab plus tremelimumab plus EP continued to numerically improve overall survival, compared with EP alone (HR, 0.81); median OS in that arm was 10.4 months, and 15.3% of patients were alive at 36 months, he noted.

Serious adverse events occurred in 32.5%, 47.4%, and 36.5% of patients in the durvalumab with EP, durvalumab plus tremelimumab plus EP, and EP arms respectively, and adverse events leading to death occurred in 5.3%, 10.9%, and 6.0%, respectively.

The findings are “really encouraging and unprecedented, frankly,” said session chair Alfredo Addeo, MD, of University Hospital, Geneva.

“They are setting the bar for competitors,” he said, referencing the IMpower 133 trial looking at atezolizumab with chemotherapy in ES-SCLC.

The CASPIAN study was funded by AstraZeneca. Dr. Paz-Ares reported relationships with multiple pharmaceutical companies.

[email protected]

The overall survival benefit with durvalumab plus etoposide and cisplatin/carboplatin versus EP alone for the first-line treatment of extensive-stage small cell lung cancer (ES-SCLC) as demonstrated in the phase 3 CASPIAN trial was sustained beyond 3 years, according to a planned exploratory analysis.

The durable overall survival (OS) benefit and the well-tolerated safety profile of the durvalumab with EP therapy further establishes the combination as the standard of care for the first-line treatment of ES-SCLC, Luis Paz-Ares, MD, reported at the 2021 European Society for Medical Oncology Congress on Sept. 18 (abstract LBA61).

At 3 years, there is more than three times the survival in patients with durvalumab and EP versus EP, and at the same time, the adverse-event profile continues to be favorable,” said Dr. Paz-Ares of Universidad Complutense & Ciberonc, Madrid.

This is the longest follow-up reported to date for a phase 3 trial of a programmed death–ligand 1 inhibitor and EP in this setting, he said.

The CASPIAN trial included 805 treatment-naive patients with ES-SCLC who were randomized 1:1:1 to receive 1,500 mg of durvalumab with EP every 3 weeks, 1,500 mg of durvalumab at 75 mg of tremelimumab and EP every 3 weeks, or EP alone. Patients in the durvalumab arms received four cycles of treatment followed by maintenance durvalumab, and those in the EP-only arm received up to six cycles of EP.

Primary outcomes data from the trial showed a significant overall survival benefit with durvalumab and EP versus EP alone (hazard ratio, 0.73), as did a subsequent analysis after a median follow-up of 25.1 mo (HR, 0.75).

Durvalumab with tremelimumab and EP numerically improved overall survival versus EP (HR, 0.82), but did not reach statistical significance.

At median follow up of 39.4 months, the durvalumab and EP combination showed sustained improvement in overall survival versus EP alone (HR, 0.71).

Median overall survival was 12.9 versus 10.5 months. OS was 22.9% versus 13.9% at 24 months, and 17.6% versus 5.8% at 36 months with durvalumab with EP versus EP, respectively, Dr. Paz-Ares said.

Durvalumab plus tremelimumab plus EP continued to numerically improve overall survival, compared with EP alone (HR, 0.81); median OS in that arm was 10.4 months, and 15.3% of patients were alive at 36 months, he noted.

Serious adverse events occurred in 32.5%, 47.4%, and 36.5% of patients in the durvalumab with EP, durvalumab plus tremelimumab plus EP, and EP arms respectively, and adverse events leading to death occurred in 5.3%, 10.9%, and 6.0%, respectively.

The findings are “really encouraging and unprecedented, frankly,” said session chair Alfredo Addeo, MD, of University Hospital, Geneva.

“They are setting the bar for competitors,” he said, referencing the IMpower 133 trial looking at atezolizumab with chemotherapy in ES-SCLC.

The CASPIAN study was funded by AstraZeneca. Dr. Paz-Ares reported relationships with multiple pharmaceutical companies.

[email protected]

A phase 3, randomized, double-blind, controlled trial has shown that oteseconazole (Mycovia Pharmaceuticals), an oral antifungal agent, is safe and effective in treating acute and recurrent yeast infections (vulvovaginal candidiasis [VVC]) and in preventing  recurrence of acute VVC episodes.

Findings of the ultraVIOLET trial, which compared oteseconazole with the standard fluconazole, were presented at IDWeek 2021, an annual scientific meeting on infectious diseases, by lead author Mark G. Martens, MD, a professor in the department of obstetrics and gynecology at Drexel University College of Medicine in Philadelphia.

About 75% of all women will have a yeast infection in their lifetime, Dr. Martens noted. About 138 million women worldwide have recurring episodes (at least three acute episodes in the last year) of the debilitating condition.

“Recurrent vulvovaginal candidiasis typically requires treatment of the acute episode followed by long-term suppressive therapy with either weekly or biweekly fluconazole,” Dr. Martens said. However, when therapy stops, more than 50% of patients with recurrent VVC experience an infection within the next 6 months, which takes a significant toll on daily life.

Additionally, fluconazole has been linked with safety issues concerning chronic dosing, he said, citing liver toxicity, drug-drug interactions and “increased risk of miscarriage and birth defects when used during pregnancy.”

Topical treatments have been associated with messy application and burning, he noted.

For this study, researchers enrolled 219 women with a history of recurrent VVC at 51 U.S. sites. Participants were randomized either to 600 mg oteseconazole on day 1, 450 mg oteseconazole on day 2 or placebo capsules; or three sequential 150 mg doses (every 72 hours) of fluconazole together with matching placebo capsules.

In the maintenance phase, 185 women with resolved acute VVC (clinical signs and symptoms were scored below 3) on day 14 received 150 mg oteseconazole or placebo weekly for 11 weeks.

Oteseconazole was superior to fluconazole/placebo in the proportion of subjects with at least one culture-verified acute VVC episode through week 50 in the intent-to-treat population (P < .001) which included subjects who failed to clear their infection in the induction phase.

The average percentage of participants with at least one culture-verified acute VVC episode through week 50 was lower in the oteseconazole group (5.1%), compared with the fluconazole/placebo group (42.2%).

Oteseconazole was noninferior to fluconazole in the proportion of subjects with resolved acute VVC infections at day 14 – 93.2% for the oteseconazole group vs. 95.8% for the fluconazole/placebo group.

The percentages of women who had at least one treatment-emergent adverse event (TEAE) were similar – 54% in the oteseconazole group and 64% in the fluconazole/placebo group.  Most TEAEs were mild or moderate and there were no drug-related SAEs or adverse effects on liver function.

“There was no difference in the two groups in he baseline characteristics of age, race, and history of diabetes,” he said.

Oluwatosin Goje, MD, an ob.gyn. with the Cleveland Clinic told this news organization that the drug may offer another option for women who don’t respond to azoles.

“The CDC guidelines say, and I agree, that most episodes of recurrent VVC that are caused by Candida albicans will respond to topical azoles, to oral azoles, to the known drugs that are available. You just may have to use them for a prolonged period of time,” Dr. Goje said. But some patients won’t respond to azoles, the currently available drugs, and topical treatments – so new options are welcome for them, she noted.

She pointed out that the U.S. Food and Drug Administration in June approved ibrexafungerp (Brexafemme), the first oral nonazole treatment for vaginal yeast infections. It was the first approved medicine in a novel antifungal class in more than 2 decades.

Dr. Goje, who runs a large clinic with substantial numbers of women with recurrent yeast infections, said the psychosocial problems women with recurrent yeast infections face – and the time off work and money spent trying to get temporary relief from over-the-counter medications – is underestimated.

“Women have long suffered vaginitis. It can be a lot of social and economic burden. So anything in the toolbox to help women is welcome,” Dr. Goje said.

The study was sponsored by Mycovia Pharmaceuticals. Dr. Martens reports no relevant financial relationships. Several coauthors are either employees of Mycovia or receive support from the company. Dr. Goje has disclosed no relevant financial relationships.

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

A phase 3, randomized, double-blind, controlled trial has shown that oteseconazole (Mycovia Pharmaceuticals), an oral antifungal agent, is safe and effective in treating acute and recurrent yeast infections (vulvovaginal candidiasis [VVC]) and in preventing  recurrence of acute VVC episodes.

Findings of the ultraVIOLET trial, which compared oteseconazole with the standard fluconazole, were presented at IDWeek 2021, an annual scientific meeting on infectious diseases, by lead author Mark G. Martens, MD, a professor in the department of obstetrics and gynecology at Drexel University College of Medicine in Philadelphia.

About 75% of all women will have a yeast infection in their lifetime, Dr. Martens noted. About 138 million women worldwide have recurring episodes (at least three acute episodes in the last year) of the debilitating condition.

“Recurrent vulvovaginal candidiasis typically requires treatment of the acute episode followed by long-term suppressive therapy with either weekly or biweekly fluconazole,” Dr. Martens said. However, when therapy stops, more than 50% of patients with recurrent VVC experience an infection within the next 6 months, which takes a significant toll on daily life.

Additionally, fluconazole has been linked with safety issues concerning chronic dosing, he said, citing liver toxicity, drug-drug interactions and “increased risk of miscarriage and birth defects when used during pregnancy.”

Topical treatments have been associated with messy application and burning, he noted.

For this study, researchers enrolled 219 women with a history of recurrent VVC at 51 U.S. sites. Participants were randomized either to 600 mg oteseconazole on day 1, 450 mg oteseconazole on day 2 or placebo capsules; or three sequential 150 mg doses (every 72 hours) of fluconazole together with matching placebo capsules.

In the maintenance phase, 185 women with resolved acute VVC (clinical signs and symptoms were scored below 3) on day 14 received 150 mg oteseconazole or placebo weekly for 11 weeks.

Oteseconazole was superior to fluconazole/placebo in the proportion of subjects with at least one culture-verified acute VVC episode through week 50 in the intent-to-treat population (P < .001) which included subjects who failed to clear their infection in the induction phase.

The average percentage of participants with at least one culture-verified acute VVC episode through week 50 was lower in the oteseconazole group (5.1%), compared with the fluconazole/placebo group (42.2%).

Oteseconazole was noninferior to fluconazole in the proportion of subjects with resolved acute VVC infections at day 14 – 93.2% for the oteseconazole group vs. 95.8% for the fluconazole/placebo group.

The percentages of women who had at least one treatment-emergent adverse event (TEAE) were similar – 54% in the oteseconazole group and 64% in the fluconazole/placebo group.  Most TEAEs were mild or moderate and there were no drug-related SAEs or adverse effects on liver function.

“There was no difference in the two groups in he baseline characteristics of age, race, and history of diabetes,” he said.

Oluwatosin Goje, MD, an ob.gyn. with the Cleveland Clinic told this news organization that the drug may offer another option for women who don’t respond to azoles.

“The CDC guidelines say, and I agree, that most episodes of recurrent VVC that are caused by Candida albicans will respond to topical azoles, to oral azoles, to the known drugs that are available. You just may have to use them for a prolonged period of time,” Dr. Goje said. But some patients won’t respond to azoles, the currently available drugs, and topical treatments – so new options are welcome for them, she noted.

She pointed out that the U.S. Food and Drug Administration in June approved ibrexafungerp (Brexafemme), the first oral nonazole treatment for vaginal yeast infections. It was the first approved medicine in a novel antifungal class in more than 2 decades.

Dr. Goje, who runs a large clinic with substantial numbers of women with recurrent yeast infections, said the psychosocial problems women with recurrent yeast infections face – and the time off work and money spent trying to get temporary relief from over-the-counter medications – is underestimated.

“Women have long suffered vaginitis. It can be a lot of social and economic burden. So anything in the toolbox to help women is welcome,” Dr. Goje said.

The study was sponsored by Mycovia Pharmaceuticals. Dr. Martens reports no relevant financial relationships. Several coauthors are either employees of Mycovia or receive support from the company. Dr. Goje has disclosed no relevant financial relationships.

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

A phase 3, randomized, double-blind, controlled trial has shown that oteseconazole (Mycovia Pharmaceuticals), an oral antifungal agent, is safe and effective in treating acute and recurrent yeast infections (vulvovaginal candidiasis [VVC]) and in preventing  recurrence of acute VVC episodes.

Findings of the ultraVIOLET trial, which compared oteseconazole with the standard fluconazole, were presented at IDWeek 2021, an annual scientific meeting on infectious diseases, by lead author Mark G. Martens, MD, a professor in the department of obstetrics and gynecology at Drexel University College of Medicine in Philadelphia.

About 75% of all women will have a yeast infection in their lifetime, Dr. Martens noted. About 138 million women worldwide have recurring episodes (at least three acute episodes in the last year) of the debilitating condition.

“Recurrent vulvovaginal candidiasis typically requires treatment of the acute episode followed by long-term suppressive therapy with either weekly or biweekly fluconazole,” Dr. Martens said. However, when therapy stops, more than 50% of patients with recurrent VVC experience an infection within the next 6 months, which takes a significant toll on daily life.

Additionally, fluconazole has been linked with safety issues concerning chronic dosing, he said, citing liver toxicity, drug-drug interactions and “increased risk of miscarriage and birth defects when used during pregnancy.”

Topical treatments have been associated with messy application and burning, he noted.

For this study, researchers enrolled 219 women with a history of recurrent VVC at 51 U.S. sites. Participants were randomized either to 600 mg oteseconazole on day 1, 450 mg oteseconazole on day 2 or placebo capsules; or three sequential 150 mg doses (every 72 hours) of fluconazole together with matching placebo capsules.

In the maintenance phase, 185 women with resolved acute VVC (clinical signs and symptoms were scored below 3) on day 14 received 150 mg oteseconazole or placebo weekly for 11 weeks.

Oteseconazole was superior to fluconazole/placebo in the proportion of subjects with at least one culture-verified acute VVC episode through week 50 in the intent-to-treat population (P < .001) which included subjects who failed to clear their infection in the induction phase.

The average percentage of participants with at least one culture-verified acute VVC episode through week 50 was lower in the oteseconazole group (5.1%), compared with the fluconazole/placebo group (42.2%).

Oteseconazole was noninferior to fluconazole in the proportion of subjects with resolved acute VVC infections at day 14 – 93.2% for the oteseconazole group vs. 95.8% for the fluconazole/placebo group.

The percentages of women who had at least one treatment-emergent adverse event (TEAE) were similar – 54% in the oteseconazole group and 64% in the fluconazole/placebo group.  Most TEAEs were mild or moderate and there were no drug-related SAEs or adverse effects on liver function.

“There was no difference in the two groups in he baseline characteristics of age, race, and history of diabetes,” he said.

Oluwatosin Goje, MD, an ob.gyn. with the Cleveland Clinic told this news organization that the drug may offer another option for women who don’t respond to azoles.

“The CDC guidelines say, and I agree, that most episodes of recurrent VVC that are caused by Candida albicans will respond to topical azoles, to oral azoles, to the known drugs that are available. You just may have to use them for a prolonged period of time,” Dr. Goje said. But some patients won’t respond to azoles, the currently available drugs, and topical treatments – so new options are welcome for them, she noted.

She pointed out that the U.S. Food and Drug Administration in June approved ibrexafungerp (Brexafemme), the first oral nonazole treatment for vaginal yeast infections. It was the first approved medicine in a novel antifungal class in more than 2 decades.

Dr. Goje, who runs a large clinic with substantial numbers of women with recurrent yeast infections, said the psychosocial problems women with recurrent yeast infections face – and the time off work and money spent trying to get temporary relief from over-the-counter medications – is underestimated.

“Women have long suffered vaginitis. It can be a lot of social and economic burden. So anything in the toolbox to help women is welcome,” Dr. Goje said.

The study was sponsored by Mycovia Pharmaceuticals. Dr. Martens reports no relevant financial relationships. Several coauthors are either employees of Mycovia or receive support from the company. Dr. Goje has disclosed no relevant financial relationships.

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

Adults with diabetes whose blood pressure does not drop as expected at night (nondipping), or whose BP increases during the night (reverse dipping) are at higher risk of dying than peers with normal nighttime BP patterns, a longitudinal study has shown.

“Reverse dippers have more than double the risk of death for any cause over 20 years, irrespective of blood pressure control,” study investigator Martina Chiriacò, MD, University of Pisa (Italy), said in an interview.

“Primary physicians and diabetologists should look for abnormal blood pressure dipping patterns in patients with diabetes through 24-hour ambulatory blood pressure monitoring,” she added.

Dr. Chiriacò presented the research Sept. 28 at the joint scientific sessions of the American Heart Association Council on Hypertension, AHA Council on Kidney in Cardiovascular Disease, and American Society of Hypertension.
 

Scarce data

Previous studies have shown that a nondipping BP pattern is linked to renal and cardiovascular disease, both in healthy individuals and in patients with hypertension or diabetes.

“Nevertheless, the long-term effect of nondipping on mortality in diabetes is still unclear; in particular, data on reverse dippers are extremely scarce,” Dr. Chiriacò explained.

To investigate, the researchers analyzed data on 349 adults with diabetes (81% type 2 diabetes) who were followed for more than 2 decades as part of the CHAMPION study, all with available 24-hour ambulatory BP monitoring (ABPM) and heart rate variability monitoring.

Dipping, nondipping, and reverse dipping were defined as a decline of at least 10%, a decline of less than 10%, and an increase of at least 0.1% in average night-time systolic BP, compared with average daytime SBP, respectively.

The cohort involved 166 (47.6%) dippers, 144 (41.2%) nondippers, and 39 (11.2%) reverse dippers.

Compared with dippers, nondippers and reverse dippers showed a progressively higher prevalence of cardiac autonomic neuropathy, low heart rate variability, 24-hour hypertension, isolated nocturnal hypertension, postural hypotension, and lower prevalence of white-coat hypertension.

During a median follow-up of 21 years, 136 patients died (39%). 

Compared with dippers, reverse dippers and nondippers had an average reduction in survival of 2.5 years and 1.1 years, respectively, Dr. Chiriacò reported.

During follow-up, risk for all-cause mortality was about twofold higher for reverse dippers than for dippers (adjusted hazard ratio, 2.2; 95% confidence interval, 1.3-3.8; P = .003) and than for nondippers (adjusted HR, 1.8; 95% CI, 1.1-2.9; P = .34).

There was no significant difference in all-cause mortality risk between dippers and nondippers.

Notably, said Dr. Chiriacò, the one in five patients with isolated nocturnal hypertension had a reduction in survival similar to that seen in individuals with 24-hour sustained hypertension (average, 1.2 years).

Individuals with low heart rate variability over 24 hours had an average reduction in survival of 1.8 years.
 

Important underused diagnostic tool

“We believe that our study is important since it is the only available study with a follow-up longer than 20 years that explores the role of blood pressure patterns and heart rate variability as risk factors for all-cause mortality in diabetes,” Dr. Chiriacò said in an interview.

There are some available strategies to reduce BP during the night, she added. “The most tested and effective is the administration of anti-hypertensive medications in the evening rather than in the morning.”

Weighing in on the study, Maryann McLaughlin, MD, cardiologist at Mount Sinai Hospital, New York, said: “Interestingly, most physicians do not do 24-hour ambulatory blood pressure monitoring when they’re making the diagnosis of hypertension.”

“And really, the correct way to make a diagnosis of hypertension and rule out white-coat hypertension is either with a 24-hour ambulatory blood pressure monitor or use of home blood pressure monitors,” she said in an interview.

“The 24-hour ambulatory blood pressure monitor is an important diagnostic tool and a great way to really look at this issue of dipping, which is a very important physiologic parameter,” Dr. McLaughlin said.

“In our offices, we offer the 24-hour home ambulatory blood pressure monitor routinely. Most patients are receptive to it and they usually tolerate it pretty well,” Dr. McLaughlin said.

The study was funded by the University of Pisa. Dr. Chiriacò and Dr. McLaughlin have no relevant disclosures.

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

Adults with diabetes whose blood pressure does not drop as expected at night (nondipping), or whose BP increases during the night (reverse dipping) are at higher risk of dying than peers with normal nighttime BP patterns, a longitudinal study has shown.

“Reverse dippers have more than double the risk of death for any cause over 20 years, irrespective of blood pressure control,” study investigator Martina Chiriacò, MD, University of Pisa (Italy), said in an interview.

“Primary physicians and diabetologists should look for abnormal blood pressure dipping patterns in patients with diabetes through 24-hour ambulatory blood pressure monitoring,” she added.

Dr. Chiriacò presented the research Sept. 28 at the joint scientific sessions of the American Heart Association Council on Hypertension, AHA Council on Kidney in Cardiovascular Disease, and American Society of Hypertension.
 

Scarce data

Previous studies have shown that a nondipping BP pattern is linked to renal and cardiovascular disease, both in healthy individuals and in patients with hypertension or diabetes.

“Nevertheless, the long-term effect of nondipping on mortality in diabetes is still unclear; in particular, data on reverse dippers are extremely scarce,” Dr. Chiriacò explained.

To investigate, the researchers analyzed data on 349 adults with diabetes (81% type 2 diabetes) who were followed for more than 2 decades as part of the CHAMPION study, all with available 24-hour ambulatory BP monitoring (ABPM) and heart rate variability monitoring.

Dipping, nondipping, and reverse dipping were defined as a decline of at least 10%, a decline of less than 10%, and an increase of at least 0.1% in average night-time systolic BP, compared with average daytime SBP, respectively.

The cohort involved 166 (47.6%) dippers, 144 (41.2%) nondippers, and 39 (11.2%) reverse dippers.

Compared with dippers, nondippers and reverse dippers showed a progressively higher prevalence of cardiac autonomic neuropathy, low heart rate variability, 24-hour hypertension, isolated nocturnal hypertension, postural hypotension, and lower prevalence of white-coat hypertension.

During a median follow-up of 21 years, 136 patients died (39%). 

Compared with dippers, reverse dippers and nondippers had an average reduction in survival of 2.5 years and 1.1 years, respectively, Dr. Chiriacò reported.

During follow-up, risk for all-cause mortality was about twofold higher for reverse dippers than for dippers (adjusted hazard ratio, 2.2; 95% confidence interval, 1.3-3.8; P = .003) and than for nondippers (adjusted HR, 1.8; 95% CI, 1.1-2.9; P = .34).

There was no significant difference in all-cause mortality risk between dippers and nondippers.

Notably, said Dr. Chiriacò, the one in five patients with isolated nocturnal hypertension had a reduction in survival similar to that seen in individuals with 24-hour sustained hypertension (average, 1.2 years).

Individuals with low heart rate variability over 24 hours had an average reduction in survival of 1.8 years.
 

Important underused diagnostic tool

“We believe that our study is important since it is the only available study with a follow-up longer than 20 years that explores the role of blood pressure patterns and heart rate variability as risk factors for all-cause mortality in diabetes,” Dr. Chiriacò said in an interview.

There are some available strategies to reduce BP during the night, she added. “The most tested and effective is the administration of anti-hypertensive medications in the evening rather than in the morning.”

Weighing in on the study, Maryann McLaughlin, MD, cardiologist at Mount Sinai Hospital, New York, said: “Interestingly, most physicians do not do 24-hour ambulatory blood pressure monitoring when they’re making the diagnosis of hypertension.”

“And really, the correct way to make a diagnosis of hypertension and rule out white-coat hypertension is either with a 24-hour ambulatory blood pressure monitor or use of home blood pressure monitors,” she said in an interview.

“The 24-hour ambulatory blood pressure monitor is an important diagnostic tool and a great way to really look at this issue of dipping, which is a very important physiologic parameter,” Dr. McLaughlin said.

“In our offices, we offer the 24-hour home ambulatory blood pressure monitor routinely. Most patients are receptive to it and they usually tolerate it pretty well,” Dr. McLaughlin said.

The study was funded by the University of Pisa. Dr. Chiriacò and Dr. McLaughlin have no relevant disclosures.

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

Adults with diabetes whose blood pressure does not drop as expected at night (nondipping), or whose BP increases during the night (reverse dipping) are at higher risk of dying than peers with normal nighttime BP patterns, a longitudinal study has shown.

“Reverse dippers have more than double the risk of death for any cause over 20 years, irrespective of blood pressure control,” study investigator Martina Chiriacò, MD, University of Pisa (Italy), said in an interview.

“Primary physicians and diabetologists should look for abnormal blood pressure dipping patterns in patients with diabetes through 24-hour ambulatory blood pressure monitoring,” she added.

Dr. Chiriacò presented the research Sept. 28 at the joint scientific sessions of the American Heart Association Council on Hypertension, AHA Council on Kidney in Cardiovascular Disease, and American Society of Hypertension.
 

Scarce data

Previous studies have shown that a nondipping BP pattern is linked to renal and cardiovascular disease, both in healthy individuals and in patients with hypertension or diabetes.

“Nevertheless, the long-term effect of nondipping on mortality in diabetes is still unclear; in particular, data on reverse dippers are extremely scarce,” Dr. Chiriacò explained.

To investigate, the researchers analyzed data on 349 adults with diabetes (81% type 2 diabetes) who were followed for more than 2 decades as part of the CHAMPION study, all with available 24-hour ambulatory BP monitoring (ABPM) and heart rate variability monitoring.

Dipping, nondipping, and reverse dipping were defined as a decline of at least 10%, a decline of less than 10%, and an increase of at least 0.1% in average night-time systolic BP, compared with average daytime SBP, respectively.

The cohort involved 166 (47.6%) dippers, 144 (41.2%) nondippers, and 39 (11.2%) reverse dippers.

Compared with dippers, nondippers and reverse dippers showed a progressively higher prevalence of cardiac autonomic neuropathy, low heart rate variability, 24-hour hypertension, isolated nocturnal hypertension, postural hypotension, and lower prevalence of white-coat hypertension.

During a median follow-up of 21 years, 136 patients died (39%). 

Compared with dippers, reverse dippers and nondippers had an average reduction in survival of 2.5 years and 1.1 years, respectively, Dr. Chiriacò reported.

During follow-up, risk for all-cause mortality was about twofold higher for reverse dippers than for dippers (adjusted hazard ratio, 2.2; 95% confidence interval, 1.3-3.8; P = .003) and than for nondippers (adjusted HR, 1.8; 95% CI, 1.1-2.9; P = .34).

There was no significant difference in all-cause mortality risk between dippers and nondippers.

Notably, said Dr. Chiriacò, the one in five patients with isolated nocturnal hypertension had a reduction in survival similar to that seen in individuals with 24-hour sustained hypertension (average, 1.2 years).

Individuals with low heart rate variability over 24 hours had an average reduction in survival of 1.8 years.
 

Important underused diagnostic tool

“We believe that our study is important since it is the only available study with a follow-up longer than 20 years that explores the role of blood pressure patterns and heart rate variability as risk factors for all-cause mortality in diabetes,” Dr. Chiriacò said in an interview.

There are some available strategies to reduce BP during the night, she added. “The most tested and effective is the administration of anti-hypertensive medications in the evening rather than in the morning.”

Weighing in on the study, Maryann McLaughlin, MD, cardiologist at Mount Sinai Hospital, New York, said: “Interestingly, most physicians do not do 24-hour ambulatory blood pressure monitoring when they’re making the diagnosis of hypertension.”

“And really, the correct way to make a diagnosis of hypertension and rule out white-coat hypertension is either with a 24-hour ambulatory blood pressure monitor or use of home blood pressure monitors,” she said in an interview.

“The 24-hour ambulatory blood pressure monitor is an important diagnostic tool and a great way to really look at this issue of dipping, which is a very important physiologic parameter,” Dr. McLaughlin said.

“In our offices, we offer the 24-hour home ambulatory blood pressure monitor routinely. Most patients are receptive to it and they usually tolerate it pretty well,” Dr. McLaughlin said.

The study was funded by the University of Pisa. Dr. Chiriacò and Dr. McLaughlin have no relevant disclosures.

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

Prurigo pigmentosa, an uncommon inflammatory skin condition also known as Nagashima disease, is growing in frequency, possibly as a result of increased interest in the ketogenic diet, according to a dermatologist, who reviewed skin conditions common to patients of Asian descent at the Skin of Color Update 2021.

“Ketogenic diets are gaining popularity globally for weight loss. After 2-4 weeks [on a strict ketogenic diet], some patients start to notice very pruritic papules on their trunk, the so-called keto rash,” reported Hye Jin Chung, MD, director of the Asian Skin Clinic, Beth Israel Deaconess Medical Center, Boston. “Keto rash is actually prurigo pigmentosa.”

The exact pathogenesis of prurigo pigmentosa, a highly pruritic macular and papular rash with gross reticular pigmentation, is unclear, but Dr. Chung reported that the strong link with ketosis might explain why more cases are now being encountered outside of east Asia. Ketosis or conditions associated with a high risk for ketosis, such as anorexia nervosa, diabetes mellitus, or recent bariatric surgery, have been linked to prurigo pigmentosa in all skin types and ethnicities.

“I tell my residents that this is a disease you will never forget after your first case,” she said.

The differential diagnosis includes contact dermatitis and other inflammatory disorders, but Dr. Chung said that the reticular pattern of the lesions is a relatively unique feature. Confluent and reticulated papillomatosis (CARP) shares a pattern of reticulated lesions, but Dr. Chung said it lacks the inflammatory erythematous papules and the severe pruritus common to prurigo pigmentosa.

Histologically, the pattern evolves. It begins as a perivascular infiltration dominated by neutrophils and eosinophils with hyperkeratosis, acanthosis, and spongiosis. Over time, Dr. Chung said that the histologic picture shows an increasing degree of dyskeratosis as keratinocytes die.

Prurigo pigmentosa was first described 50 years ago by Masaji Nagashima, MD, who published a report on eight patients in Japan with a pruriginous truncal dermatosis featuring symmetrical pigmentation. Most subsequent reports were also from Japan or other east Asian countries, but it has since spread.

This global spread was captured in a recently published review of 115 published studies and case reports from 24 countries. In this review, the proportion of studies from Europe (36.5%) approached that of those from east Asia (38.2%), even if 76% of the patients for whom race was reported were of Asian ethnicity.

Of the 369 patients evaluated in these studies and case reports, 72.1% were female. The mean age was 25.6 years. In the studies originating outside of Asia, prurigo pigmentosa was reported in a spectrum of skin types and ethnicities, including Whites, Blacks, and Hispanics. The lowest reported incidence has been in the latter two groups, but the authors of the review speculated that this condition is likely being underdiagnosed in non-Asian individuals.

Dr. Chung agreed, and she cautioned that the consequences typically result in a significant delay for achieving disease control. In recounting a recent case of prurigo pigmentosa at her center, she said that the 59-year-old Asian patient had been initiated on topical steroids and oral antihistamines by her primary care physician before she was referred. This is a common and reasonable strategy for a highly pruritic rash potentially caused by contact dermatitis, but it is ineffective for this disorder.

“Prurigo pigmentosa requires anti-inflammatory agents,” she explained. She said that doxycycline and minocycline are the treatments of choice, but noted that there are also reports of efficacy with dapsone, macrolide antibiotics, and isotretinoin.

In her most recent case, she initiated the patient on 100 mg of doxycycline twice daily. There was significant improvement within 2 weeks, and the rash resolved within a month with no relapse in follow-up that now exceeds 12 months, Dr. Chung said.

According to Dr. Chung, Asian-Americans are the most rapidly growing ethnic group in the United States, making it increasingly important to be familiar with conditions common or unique to Asian skin, but prurigo pigmentosa is no longer confined to those of Asian descent. She encouraged clinicians to recognize this disorder to reduce the common delays to effective treatment.

The senior author of the recently published review of studies, Jensen Yeung, MD, of the department of dermatology, University of Toronto, agreed. He, too, believes that dermatologists need to increase their awareness of the signs and symptoms of prurigo pigmentosa – and not just in Asian patients or patients of Asian descent.

“This diagnosis is often missed,” he contended in an interview. “This condition has become more common in the past 5 years in my clinical experience.” He added that the increasing incidence might not just be related to better diagnostic accuracy, although the most significant of other possible explanations “is not yet well understood.”

Dr. Chung reports that she has no relevant financial relationships to disclose. Dr. Yeung reports financial relationships with more than 25 pharmaceutical companies, some of which produce treatments employed in the control of prurigo pigmentosa.

Prurigo pigmentosa, an uncommon inflammatory skin condition also known as Nagashima disease, is growing in frequency, possibly as a result of increased interest in the ketogenic diet, according to a dermatologist, who reviewed skin conditions common to patients of Asian descent at the Skin of Color Update 2021.

“Ketogenic diets are gaining popularity globally for weight loss. After 2-4 weeks [on a strict ketogenic diet], some patients start to notice very pruritic papules on their trunk, the so-called keto rash,” reported Hye Jin Chung, MD, director of the Asian Skin Clinic, Beth Israel Deaconess Medical Center, Boston. “Keto rash is actually prurigo pigmentosa.”

The exact pathogenesis of prurigo pigmentosa, a highly pruritic macular and papular rash with gross reticular pigmentation, is unclear, but Dr. Chung reported that the strong link with ketosis might explain why more cases are now being encountered outside of east Asia. Ketosis or conditions associated with a high risk for ketosis, such as anorexia nervosa, diabetes mellitus, or recent bariatric surgery, have been linked to prurigo pigmentosa in all skin types and ethnicities.

“I tell my residents that this is a disease you will never forget after your first case,” she said.

The differential diagnosis includes contact dermatitis and other inflammatory disorders, but Dr. Chung said that the reticular pattern of the lesions is a relatively unique feature. Confluent and reticulated papillomatosis (CARP) shares a pattern of reticulated lesions, but Dr. Chung said it lacks the inflammatory erythematous papules and the severe pruritus common to prurigo pigmentosa.

Histologically, the pattern evolves. It begins as a perivascular infiltration dominated by neutrophils and eosinophils with hyperkeratosis, acanthosis, and spongiosis. Over time, Dr. Chung said that the histologic picture shows an increasing degree of dyskeratosis as keratinocytes die.

Prurigo pigmentosa was first described 50 years ago by Masaji Nagashima, MD, who published a report on eight patients in Japan with a pruriginous truncal dermatosis featuring symmetrical pigmentation. Most subsequent reports were also from Japan or other east Asian countries, but it has since spread.

This global spread was captured in a recently published review of 115 published studies and case reports from 24 countries. In this review, the proportion of studies from Europe (36.5%) approached that of those from east Asia (38.2%), even if 76% of the patients for whom race was reported were of Asian ethnicity.

Of the 369 patients evaluated in these studies and case reports, 72.1% were female. The mean age was 25.6 years. In the studies originating outside of Asia, prurigo pigmentosa was reported in a spectrum of skin types and ethnicities, including Whites, Blacks, and Hispanics. The lowest reported incidence has been in the latter two groups, but the authors of the review speculated that this condition is likely being underdiagnosed in non-Asian individuals.

Dr. Chung agreed, and she cautioned that the consequences typically result in a significant delay for achieving disease control. In recounting a recent case of prurigo pigmentosa at her center, she said that the 59-year-old Asian patient had been initiated on topical steroids and oral antihistamines by her primary care physician before she was referred. This is a common and reasonable strategy for a highly pruritic rash potentially caused by contact dermatitis, but it is ineffective for this disorder.

“Prurigo pigmentosa requires anti-inflammatory agents,” she explained. She said that doxycycline and minocycline are the treatments of choice, but noted that there are also reports of efficacy with dapsone, macrolide antibiotics, and isotretinoin.

In her most recent case, she initiated the patient on 100 mg of doxycycline twice daily. There was significant improvement within 2 weeks, and the rash resolved within a month with no relapse in follow-up that now exceeds 12 months, Dr. Chung said.

According to Dr. Chung, Asian-Americans are the most rapidly growing ethnic group in the United States, making it increasingly important to be familiar with conditions common or unique to Asian skin, but prurigo pigmentosa is no longer confined to those of Asian descent. She encouraged clinicians to recognize this disorder to reduce the common delays to effective treatment.

The senior author of the recently published review of studies, Jensen Yeung, MD, of the department of dermatology, University of Toronto, agreed. He, too, believes that dermatologists need to increase their awareness of the signs and symptoms of prurigo pigmentosa – and not just in Asian patients or patients of Asian descent.

“This diagnosis is often missed,” he contended in an interview. “This condition has become more common in the past 5 years in my clinical experience.” He added that the increasing incidence might not just be related to better diagnostic accuracy, although the most significant of other possible explanations “is not yet well understood.”

Dr. Chung reports that she has no relevant financial relationships to disclose. Dr. Yeung reports financial relationships with more than 25 pharmaceutical companies, some of which produce treatments employed in the control of prurigo pigmentosa.

Prurigo pigmentosa, an uncommon inflammatory skin condition also known as Nagashima disease, is growing in frequency, possibly as a result of increased interest in the ketogenic diet, according to a dermatologist, who reviewed skin conditions common to patients of Asian descent at the Skin of Color Update 2021.

“Ketogenic diets are gaining popularity globally for weight loss. After 2-4 weeks [on a strict ketogenic diet], some patients start to notice very pruritic papules on their trunk, the so-called keto rash,” reported Hye Jin Chung, MD, director of the Asian Skin Clinic, Beth Israel Deaconess Medical Center, Boston. “Keto rash is actually prurigo pigmentosa.”

The exact pathogenesis of prurigo pigmentosa, a highly pruritic macular and papular rash with gross reticular pigmentation, is unclear, but Dr. Chung reported that the strong link with ketosis might explain why more cases are now being encountered outside of east Asia. Ketosis or conditions associated with a high risk for ketosis, such as anorexia nervosa, diabetes mellitus, or recent bariatric surgery, have been linked to prurigo pigmentosa in all skin types and ethnicities.

“I tell my residents that this is a disease you will never forget after your first case,” she said.

The differential diagnosis includes contact dermatitis and other inflammatory disorders, but Dr. Chung said that the reticular pattern of the lesions is a relatively unique feature. Confluent and reticulated papillomatosis (CARP) shares a pattern of reticulated lesions, but Dr. Chung said it lacks the inflammatory erythematous papules and the severe pruritus common to prurigo pigmentosa.

Histologically, the pattern evolves. It begins as a perivascular infiltration dominated by neutrophils and eosinophils with hyperkeratosis, acanthosis, and spongiosis. Over time, Dr. Chung said that the histologic picture shows an increasing degree of dyskeratosis as keratinocytes die.

Prurigo pigmentosa was first described 50 years ago by Masaji Nagashima, MD, who published a report on eight patients in Japan with a pruriginous truncal dermatosis featuring symmetrical pigmentation. Most subsequent reports were also from Japan or other east Asian countries, but it has since spread.

This global spread was captured in a recently published review of 115 published studies and case reports from 24 countries. In this review, the proportion of studies from Europe (36.5%) approached that of those from east Asia (38.2%), even if 76% of the patients for whom race was reported were of Asian ethnicity.

Of the 369 patients evaluated in these studies and case reports, 72.1% were female. The mean age was 25.6 years. In the studies originating outside of Asia, prurigo pigmentosa was reported in a spectrum of skin types and ethnicities, including Whites, Blacks, and Hispanics. The lowest reported incidence has been in the latter two groups, but the authors of the review speculated that this condition is likely being underdiagnosed in non-Asian individuals.

Dr. Chung agreed, and she cautioned that the consequences typically result in a significant delay for achieving disease control. In recounting a recent case of prurigo pigmentosa at her center, she said that the 59-year-old Asian patient had been initiated on topical steroids and oral antihistamines by her primary care physician before she was referred. This is a common and reasonable strategy for a highly pruritic rash potentially caused by contact dermatitis, but it is ineffective for this disorder.

“Prurigo pigmentosa requires anti-inflammatory agents,” she explained. She said that doxycycline and minocycline are the treatments of choice, but noted that there are also reports of efficacy with dapsone, macrolide antibiotics, and isotretinoin.

In her most recent case, she initiated the patient on 100 mg of doxycycline twice daily. There was significant improvement within 2 weeks, and the rash resolved within a month with no relapse in follow-up that now exceeds 12 months, Dr. Chung said.

According to Dr. Chung, Asian-Americans are the most rapidly growing ethnic group in the United States, making it increasingly important to be familiar with conditions common or unique to Asian skin, but prurigo pigmentosa is no longer confined to those of Asian descent. She encouraged clinicians to recognize this disorder to reduce the common delays to effective treatment.

The senior author of the recently published review of studies, Jensen Yeung, MD, of the department of dermatology, University of Toronto, agreed. He, too, believes that dermatologists need to increase their awareness of the signs and symptoms of prurigo pigmentosa – and not just in Asian patients or patients of Asian descent.

“This diagnosis is often missed,” he contended in an interview. “This condition has become more common in the past 5 years in my clinical experience.” He added that the increasing incidence might not just be related to better diagnostic accuracy, although the most significant of other possible explanations “is not yet well understood.”

Dr. Chung reports that she has no relevant financial relationships to disclose. Dr. Yeung reports financial relationships with more than 25 pharmaceutical companies, some of which produce treatments employed in the control of prurigo pigmentosa.

Bone marrow derived autologous cell therapy (ACT) has been shown to significantly reduce the rate of major amputation at 5 years in people with diabetes who developed critical limb-threatening ischemia (CLTI).

In a study of 130 patients, 64% of 42 patients who were treated conservatively needed a major amputation at 5 years versus just 30% of 45 patients who had been treated with ACT (P = .011).

This compared favorably to the results seen with repeated percutaneous angioplasty (re-PTA), where just 20.9% of 43 patients underwent limb salvage (P = .002 vs. conservative therapy).

Furthermore, amputation-free survival was significantly longer in both active groups, Michal Dubský, MD, PhD, FRSPH, reported at the annual meeting of the European Association for the Study of Diabetes.

Dr. Dubský, of the Institute for Clinical and Experimental Medicine and Charles University in Prague, also reported that fewer patients who had undergone re-PTA or ACT than conservative treatment had died by 5 years (25.8% and 35.6%, respectively, vs. 61.9%), but that the difference was significant only for the revascularization procedure (P = .012).

Based on these findings, “we believe that autologous cell therapy seems to be an appropriate alternative to repeated PTA even for patients with no-option chronic limb-threatening ischemia,” he said.

“This is a very important area,” said Andrew J.M. Boulton, MBBS, MD, FRCP, who chaired the oral abstract presentation session during which the findings were presented.

“It is very difficult to get an evidence base from randomized studies in this area, because of the nature of the patients: They’re very sick and we all deal with them in our clinics very regularly,” added Dr. Boulton, professor of medicine within the division of diabetes, endocrinology and gastroenterology at the University of Manchester (England).

Dr. Boulton called the findings a “very important addition to what we know.”
 

New option for no-option CLTI

CLTI is associated with persistent pain at rest, ulcers, and gangrene, and can be the end result of longstanding peripheral arterial disease. Within the first year of presentation, there’s a 30% chance of having a major amputation and a 25% chance of dying.

Importantly, said Dr. Dubský, “there is a big difference in this diagnosis” between patients with diabetes and those without. For instance, CLTI is more diffuse in patients with diabetes than in those without, different arteries are affected and the sclerosis seen can be more rigid and “full of calcium.”

While surgery to improve blood flow is the standard of care, not everyone is suitable. Bypass surgery or endovascular procedures can be performed in only 40%-50% of patients, and even then a therapeutic effect may be seen in only a quarter of patients.

“We need some new therapeutic modalities for this diagnosis, and one of them could be autologous cell therapy,” said Dr. Dubský.
 

Study details

Dr. Dubský and coinvestigators consecutively recruited 130 patients with diabetic foot and CLTI who had been seen at their clinic over a 5-year period. Of these, 87 had not been eligible for standard revascularization and underwent ACT or were treated conservatively.

Of the patients who were not eligible for standard revascularization (‘no-option CLTI), 45 had undergone ACT and 42 had been treated conservatively. Dr. Dubský acknowledged that “his study was not prospective and randomized.”

All patients in the study had at least one unsuccessful revascularization procedure and diabetic foot ulcers, and low tissue oxygenation. The latter was defined as transcutaneous oxygen pressure (TcPO₂) of below 30 mm Hg.

There were little differences in demographic characteristics between the treatment groups, the average age ranged from 62 to 67 years, there were more men (70%-80%) than women; most patients (90%) had type 2 diabetes for at least 20 years. There were similar rates of ischemic heart disease, hypertension, dialysis, and immunosuppressive therapy.

There were no differences in baseline values of TcPO₂ between the groups, and similar improvements were seen in both the ACT and re-PTA groups versus conservative group.
 

ACT in practice

With such promising results, what about the practicalities of harvesting a patient’s bone marrow to make the ACT?

“Bone marrow harvesting usually takes about 20 minutes,” Dr. Dubský said. It then takes another 45 minutes to separate the cells and make the cell suspension, and then maybe another 10 minutes or so to administer this to the patient, which is done by injecting into the calf muscles and small muscles of the foot, aided by computed tomography. The whole process may take up to 2 hours, he said.

“Patients are under local or general anesthesia, so there is no pain during the procedure,” Dr. Dubský reassured. “Afterwards we sometimes see small hematoma[s], with low-intensity pain that responds well to usual analgesic therapy.”

Computed tomography was used to help guide the injections, which was advantageous, Dr. Boulton pointed out, because it was “less invasive than angioplasty in these very sick people with very distal lesions, many of whom already have renal problems.”

“It is surprising though, that everybody had re-PTA and not one had vascular surgery,” he suggested. Dr. Boulton added, however: “These are very important observations; they help us a lot in an area where there’s unlikely to be a full RCT.”

The next step in this research is to see if combining ACT and re-PTA could lead to even better results.

The study was funded by the Czech Republic Ministry of Health. Dr. Dubský had nothing to disclose. Dr. Boulton made no statement about his conflicts of interest.

Bone marrow derived autologous cell therapy (ACT) has been shown to significantly reduce the rate of major amputation at 5 years in people with diabetes who developed critical limb-threatening ischemia (CLTI).

In a study of 130 patients, 64% of 42 patients who were treated conservatively needed a major amputation at 5 years versus just 30% of 45 patients who had been treated with ACT (P = .011).

This compared favorably to the results seen with repeated percutaneous angioplasty (re-PTA), where just 20.9% of 43 patients underwent limb salvage (P = .002 vs. conservative therapy).

Furthermore, amputation-free survival was significantly longer in both active groups, Michal Dubský, MD, PhD, FRSPH, reported at the annual meeting of the European Association for the Study of Diabetes.

Dr. Dubský, of the Institute for Clinical and Experimental Medicine and Charles University in Prague, also reported that fewer patients who had undergone re-PTA or ACT than conservative treatment had died by 5 years (25.8% and 35.6%, respectively, vs. 61.9%), but that the difference was significant only for the revascularization procedure (P = .012).

Based on these findings, “we believe that autologous cell therapy seems to be an appropriate alternative to repeated PTA even for patients with no-option chronic limb-threatening ischemia,” he said.

“This is a very important area,” said Andrew J.M. Boulton, MBBS, MD, FRCP, who chaired the oral abstract presentation session during which the findings were presented.

“It is very difficult to get an evidence base from randomized studies in this area, because of the nature of the patients: They’re very sick and we all deal with them in our clinics very regularly,” added Dr. Boulton, professor of medicine within the division of diabetes, endocrinology and gastroenterology at the University of Manchester (England).

Dr. Boulton called the findings a “very important addition to what we know.”
 

New option for no-option CLTI

CLTI is associated with persistent pain at rest, ulcers, and gangrene, and can be the end result of longstanding peripheral arterial disease. Within the first year of presentation, there’s a 30% chance of having a major amputation and a 25% chance of dying.

Importantly, said Dr. Dubský, “there is a big difference in this diagnosis” between patients with diabetes and those without. For instance, CLTI is more diffuse in patients with diabetes than in those without, different arteries are affected and the sclerosis seen can be more rigid and “full of calcium.”

While surgery to improve blood flow is the standard of care, not everyone is suitable. Bypass surgery or endovascular procedures can be performed in only 40%-50% of patients, and even then a therapeutic effect may be seen in only a quarter of patients.

“We need some new therapeutic modalities for this diagnosis, and one of them could be autologous cell therapy,” said Dr. Dubský.
 

Study details

Dr. Dubský and coinvestigators consecutively recruited 130 patients with diabetic foot and CLTI who had been seen at their clinic over a 5-year period. Of these, 87 had not been eligible for standard revascularization and underwent ACT or were treated conservatively.

Of the patients who were not eligible for standard revascularization (‘no-option CLTI), 45 had undergone ACT and 42 had been treated conservatively. Dr. Dubský acknowledged that “his study was not prospective and randomized.”

All patients in the study had at least one unsuccessful revascularization procedure and diabetic foot ulcers, and low tissue oxygenation. The latter was defined as transcutaneous oxygen pressure (TcPO₂) of below 30 mm Hg.

There were little differences in demographic characteristics between the treatment groups, the average age ranged from 62 to 67 years, there were more men (70%-80%) than women; most patients (90%) had type 2 diabetes for at least 20 years. There were similar rates of ischemic heart disease, hypertension, dialysis, and immunosuppressive therapy.

There were no differences in baseline values of TcPO₂ between the groups, and similar improvements were seen in both the ACT and re-PTA groups versus conservative group.
 

ACT in practice

With such promising results, what about the practicalities of harvesting a patient’s bone marrow to make the ACT?

“Bone marrow harvesting usually takes about 20 minutes,” Dr. Dubský said. It then takes another 45 minutes to separate the cells and make the cell suspension, and then maybe another 10 minutes or so to administer this to the patient, which is done by injecting into the calf muscles and small muscles of the foot, aided by computed tomography. The whole process may take up to 2 hours, he said.

“Patients are under local or general anesthesia, so there is no pain during the procedure,” Dr. Dubský reassured. “Afterwards we sometimes see small hematoma[s], with low-intensity pain that responds well to usual analgesic therapy.”

Computed tomography was used to help guide the injections, which was advantageous, Dr. Boulton pointed out, because it was “less invasive than angioplasty in these very sick people with very distal lesions, many of whom already have renal problems.”

“It is surprising though, that everybody had re-PTA and not one had vascular surgery,” he suggested. Dr. Boulton added, however: “These are very important observations; they help us a lot in an area where there’s unlikely to be a full RCT.”

The next step in this research is to see if combining ACT and re-PTA could lead to even better results.

The study was funded by the Czech Republic Ministry of Health. Dr. Dubský had nothing to disclose. Dr. Boulton made no statement about his conflicts of interest.

Bone marrow derived autologous cell therapy (ACT) has been shown to significantly reduce the rate of major amputation at 5 years in people with diabetes who developed critical limb-threatening ischemia (CLTI).

In a study of 130 patients, 64% of 42 patients who were treated conservatively needed a major amputation at 5 years versus just 30% of 45 patients who had been treated with ACT (P = .011).

This compared favorably to the results seen with repeated percutaneous angioplasty (re-PTA), where just 20.9% of 43 patients underwent limb salvage (P = .002 vs. conservative therapy).

Furthermore, amputation-free survival was significantly longer in both active groups, Michal Dubský, MD, PhD, FRSPH, reported at the annual meeting of the European Association for the Study of Diabetes.

Dr. Dubský, of the Institute for Clinical and Experimental Medicine and Charles University in Prague, also reported that fewer patients who had undergone re-PTA or ACT than conservative treatment had died by 5 years (25.8% and 35.6%, respectively, vs. 61.9%), but that the difference was significant only for the revascularization procedure (P = .012).

Based on these findings, “we believe that autologous cell therapy seems to be an appropriate alternative to repeated PTA even for patients with no-option chronic limb-threatening ischemia,” he said.

“This is a very important area,” said Andrew J.M. Boulton, MBBS, MD, FRCP, who chaired the oral abstract presentation session during which the findings were presented.

“It is very difficult to get an evidence base from randomized studies in this area, because of the nature of the patients: They’re very sick and we all deal with them in our clinics very regularly,” added Dr. Boulton, professor of medicine within the division of diabetes, endocrinology and gastroenterology at the University of Manchester (England).

Dr. Boulton called the findings a “very important addition to what we know.”
 

New option for no-option CLTI

CLTI is associated with persistent pain at rest, ulcers, and gangrene, and can be the end result of longstanding peripheral arterial disease. Within the first year of presentation, there’s a 30% chance of having a major amputation and a 25% chance of dying.

Importantly, said Dr. Dubský, “there is a big difference in this diagnosis” between patients with diabetes and those without. For instance, CLTI is more diffuse in patients with diabetes than in those without, different arteries are affected and the sclerosis seen can be more rigid and “full of calcium.”

While surgery to improve blood flow is the standard of care, not everyone is suitable. Bypass surgery or endovascular procedures can be performed in only 40%-50% of patients, and even then a therapeutic effect may be seen in only a quarter of patients.

“We need some new therapeutic modalities for this diagnosis, and one of them could be autologous cell therapy,” said Dr. Dubský.
 

Study details

Dr. Dubský and coinvestigators consecutively recruited 130 patients with diabetic foot and CLTI who had been seen at their clinic over a 5-year period. Of these, 87 had not been eligible for standard revascularization and underwent ACT or were treated conservatively.

Of the patients who were not eligible for standard revascularization (‘no-option CLTI), 45 had undergone ACT and 42 had been treated conservatively. Dr. Dubský acknowledged that “his study was not prospective and randomized.”

All patients in the study had at least one unsuccessful revascularization procedure and diabetic foot ulcers, and low tissue oxygenation. The latter was defined as transcutaneous oxygen pressure (TcPO₂) of below 30 mm Hg.

There were little differences in demographic characteristics between the treatment groups, the average age ranged from 62 to 67 years, there were more men (70%-80%) than women; most patients (90%) had type 2 diabetes for at least 20 years. There were similar rates of ischemic heart disease, hypertension, dialysis, and immunosuppressive therapy.

There were no differences in baseline values of TcPO₂ between the groups, and similar improvements were seen in both the ACT and re-PTA groups versus conservative group.
 

ACT in practice

With such promising results, what about the practicalities of harvesting a patient’s bone marrow to make the ACT?

“Bone marrow harvesting usually takes about 20 minutes,” Dr. Dubský said. It then takes another 45 minutes to separate the cells and make the cell suspension, and then maybe another 10 minutes or so to administer this to the patient, which is done by injecting into the calf muscles and small muscles of the foot, aided by computed tomography. The whole process may take up to 2 hours, he said.

“Patients are under local or general anesthesia, so there is no pain during the procedure,” Dr. Dubský reassured. “Afterwards we sometimes see small hematoma[s], with low-intensity pain that responds well to usual analgesic therapy.”

Computed tomography was used to help guide the injections, which was advantageous, Dr. Boulton pointed out, because it was “less invasive than angioplasty in these very sick people with very distal lesions, many of whom already have renal problems.”

“It is surprising though, that everybody had re-PTA and not one had vascular surgery,” he suggested. Dr. Boulton added, however: “These are very important observations; they help us a lot in an area where there’s unlikely to be a full RCT.”

The next step in this research is to see if combining ACT and re-PTA could lead to even better results.

The study was funded by the Czech Republic Ministry of Health. Dr. Dubský had nothing to disclose. Dr. Boulton made no statement about his conflicts of interest.

Racial and ethnic disparities persist in the use of Mohs surgery to treat dermatofibrosarcoma protuberans, according to the results of a retrospective cohort study of more than 2,000 patients.

Current guidelines recommend Mohs micrographic surgery (MMS) as a first-line treatment for dermatofibrosarcoma protuberans, but the procedure may be inaccessible for certain populations and in some geographic areas, wrote Kevin J. Moore, MD, and Michael S. Chang, BA, of the department of dermatology, Brigham and Women’s Hospital, Boston, and colleagues. Wide local excision (WLE) is a less effective option; recurrence rates associated with this treatment are approximately 30% because of incomplete margin assessment, compared with about 3% with MMS, they noted.

In the study, published as a letter in the Journal of the American Academy of Dermatology, the investigators identified 2,370 cases of dermatofibrosarcoma protuberans using data from the National Cancer Institute’s Surveillance, Epidemiology and End Results (SEER) Registry from 2000 to 2018. The mean age of the patients was 44 years; 55% were women. A total of 539 patients underwent MMS and 1,831 underwent WLE.

Overall, patients in the WLE group were more likely to be younger, male, Black, and single, the researchers noted. Those who had WLE, they added, were “more commonly deceased at study end date, recipients of adjuvant chemotherapy or radiation, and had truncal tumor locations.”

In a multivariate analysis, patients who were non-Hispanic, White, or other races (including American Indian, Alaskan Native, and Pacific Islander), were significantly more likely to undergo MMS compared with Black and Hispanic patients (adjusted odd ratio [aOR], 1.46, 1.66, and 2.42, respectively). Women were also significantly more likely than were men to undergo MMS (aOR, 1.24). Individuals living in the Western part of the United States were significantly more likely to undergo MMS.

The study findings were limited by several factors including the inability to control for insurance status, lack of data on re-excision, and the use of aggregate case data, the researchers noted. However, the results highlight the disparities in use of MMS for dermatofibrosarcoma protuberans, they said.

“Because MMS is associated with significantly improved outcomes, identifying at-risk patient populations and barriers to accessing MMS is essential,” the researchers noted. The results suggest that disparities persist in accessing MMS for many patients, notably Black and Hispanic males, they said. “Further work is necessary to identify mechanisms for increasing access to MMS,” they concluded.

The study received no outside funding. The researchers had no financial conflicts to disclose.

Racial and ethnic disparities persist in the use of Mohs surgery to treat dermatofibrosarcoma protuberans, according to the results of a retrospective cohort study of more than 2,000 patients.

Current guidelines recommend Mohs micrographic surgery (MMS) as a first-line treatment for dermatofibrosarcoma protuberans, but the procedure may be inaccessible for certain populations and in some geographic areas, wrote Kevin J. Moore, MD, and Michael S. Chang, BA, of the department of dermatology, Brigham and Women’s Hospital, Boston, and colleagues. Wide local excision (WLE) is a less effective option; recurrence rates associated with this treatment are approximately 30% because of incomplete margin assessment, compared with about 3% with MMS, they noted.

In the study, published as a letter in the Journal of the American Academy of Dermatology, the investigators identified 2,370 cases of dermatofibrosarcoma protuberans using data from the National Cancer Institute’s Surveillance, Epidemiology and End Results (SEER) Registry from 2000 to 2018. The mean age of the patients was 44 years; 55% were women. A total of 539 patients underwent MMS and 1,831 underwent WLE.

Overall, patients in the WLE group were more likely to be younger, male, Black, and single, the researchers noted. Those who had WLE, they added, were “more commonly deceased at study end date, recipients of adjuvant chemotherapy or radiation, and had truncal tumor locations.”

In a multivariate analysis, patients who were non-Hispanic, White, or other races (including American Indian, Alaskan Native, and Pacific Islander), were significantly more likely to undergo MMS compared with Black and Hispanic patients (adjusted odd ratio [aOR], 1.46, 1.66, and 2.42, respectively). Women were also significantly more likely than were men to undergo MMS (aOR, 1.24). Individuals living in the Western part of the United States were significantly more likely to undergo MMS.

The study findings were limited by several factors including the inability to control for insurance status, lack of data on re-excision, and the use of aggregate case data, the researchers noted. However, the results highlight the disparities in use of MMS for dermatofibrosarcoma protuberans, they said.

“Because MMS is associated with significantly improved outcomes, identifying at-risk patient populations and barriers to accessing MMS is essential,” the researchers noted. The results suggest that disparities persist in accessing MMS for many patients, notably Black and Hispanic males, they said. “Further work is necessary to identify mechanisms for increasing access to MMS,” they concluded.

The study received no outside funding. The researchers had no financial conflicts to disclose.

Racial and ethnic disparities persist in the use of Mohs surgery to treat dermatofibrosarcoma protuberans, according to the results of a retrospective cohort study of more than 2,000 patients.

Current guidelines recommend Mohs micrographic surgery (MMS) as a first-line treatment for dermatofibrosarcoma protuberans, but the procedure may be inaccessible for certain populations and in some geographic areas, wrote Kevin J. Moore, MD, and Michael S. Chang, BA, of the department of dermatology, Brigham and Women’s Hospital, Boston, and colleagues. Wide local excision (WLE) is a less effective option; recurrence rates associated with this treatment are approximately 30% because of incomplete margin assessment, compared with about 3% with MMS, they noted.

In the study, published as a letter in the Journal of the American Academy of Dermatology, the investigators identified 2,370 cases of dermatofibrosarcoma protuberans using data from the National Cancer Institute’s Surveillance, Epidemiology and End Results (SEER) Registry from 2000 to 2018. The mean age of the patients was 44 years; 55% were women. A total of 539 patients underwent MMS and 1,831 underwent WLE.

Overall, patients in the WLE group were more likely to be younger, male, Black, and single, the researchers noted. Those who had WLE, they added, were “more commonly deceased at study end date, recipients of adjuvant chemotherapy or radiation, and had truncal tumor locations.”

In a multivariate analysis, patients who were non-Hispanic, White, or other races (including American Indian, Alaskan Native, and Pacific Islander), were significantly more likely to undergo MMS compared with Black and Hispanic patients (adjusted odd ratio [aOR], 1.46, 1.66, and 2.42, respectively). Women were also significantly more likely than were men to undergo MMS (aOR, 1.24). Individuals living in the Western part of the United States were significantly more likely to undergo MMS.

The study findings were limited by several factors including the inability to control for insurance status, lack of data on re-excision, and the use of aggregate case data, the researchers noted. However, the results highlight the disparities in use of MMS for dermatofibrosarcoma protuberans, they said.

“Because MMS is associated with significantly improved outcomes, identifying at-risk patient populations and barriers to accessing MMS is essential,” the researchers noted. The results suggest that disparities persist in accessing MMS for many patients, notably Black and Hispanic males, they said. “Further work is necessary to identify mechanisms for increasing access to MMS,” they concluded.

The study received no outside funding. The researchers had no financial conflicts to disclose.

Two of the three late-breaking abstract sessions coming up this week at IDWeek 2021, an annual scientific meeting on infectious diseases, are filled with the most recent evidence on COVID-19 prevention and treatment.

Adarsh Bhimraj, MD, a vice chair of the conference, said in an interview that attendees will leave the virtual conference with an up-to-date view of what’s promising in the fight against COVID-19 globally and what questions are as yet unanswered.

Researchers will also present findings on promising new antibiotics in the pipeline, stewardship efforts, health disparities, telemedicine advances, and emerging pathogens, but at least a quarter of the program is devoted to COVID-19.

“It’s hard to ignore the elephant in the room,” Dr. Bhimraj said.

Vaccine distribution will be among the hot topics at the global conference, he said, in light of the recent decisions by the Food and Drug Administration and the Centers for Disease Control and Prevention to reserve boosters for those at greatest risk.

Although the United States and other high-resource countries are deciding who should get boosters, only 10% of the developing world has received even a single dose, he noted.

The conference will also present a worldwide view of scientific collaboration to address the COVID pandemic and pandemics yet to come, Dr. Bhimraj said.

He highlighted a talk on Oct. 2, to be delivered by South African human rights attorney and social justice activist Fatima Hassan, called “Global Vaccines and Preventive Care Inequities: Implications and Solutions Beyond the Pandemic.”

The session looks ahead to building systems to share resources and knowledge to end deadly outbreaks with an equitable approach.

“We live in a global village,” Dr. Bhimraj said. “It isn’t just the right thing to do, it’s the pragmatic thing to do.”
 

Controversies in non-COVID diseases

Controversies and new treatments are plentiful in other diseases as well.

• At an HIV session, arguments will be presented regarding the sustainability and practicalities of telemedicine in HIV. Speakers will argue for and against telemedicine as a permanent practice changer for the field.
• In a session on Oct. 1, panelists will discuss pros and cons of information published in preprints versus peer-reviewed journals and how to assess when research findings should lead to practice change.
• Also on Oct. 1, panelists in a symposium will discuss advantages and disadvantages of antifungal treatments for children who have received solid organ transplants.
• Antimicrobial stewardship continues to be a primary topic at IDWeek, this year with additional pandemic challenges. Sessions will address trends in use and diagnostic advances to help in prescribing.
• The pipeline for new antibiotics continues to face barriers regarding production and development. No new classes of antibiotics have been discovered since the 1980s. Pew has that there are too few drugs in development to meet current and anticipated need.
• This year’s program offers a symposium on private-public partnerships to help jump-start development.
• One of the most popular sessions returning this year is “Clinical Trials That Will Change Your Practice,” Dr. Bhimraj said. This year, that session will be reserved for non-COVID infectious disease research. Presenters will summarize the findings of top work published in the past year.

Around-the-world COVID view

Again this year, global experts will present a round-the-clock session called “Chasing the Sun” the day before the main sessions. It will include updates on COVID throughout the world. Barney Graham, MD, PhD, deputy director of the National Institutes of Health’s Vaccine Research Center, will kick off the program with an address on the future of vaccinology. This will be followed by updates on the state of the disease in Central and South America, Japan, Asia Pacific, India, and Africa.

Sandra Harwood, IDWeek conference secretariat, who proposed the idea for the first Chasing the Sun session last year, said in an interview that the updates will highlight particular COVID challenges experienced in various countries.

For example, leaders of India’s session will address why a potentially fatal fungal disease struck many COVID-19 patients in that country. Japan’s update will include how Olympic organizers planned for and dealt with the virus’s threat in Tokyo.

Ms. Harwood said that all the COVID sessions in Chasing the Sun and throughout the program will be free to clinicians inside and outside the conference, thanks to a grant from the CDC.

An address by CDC Director Rochelle Walensky, MD, MPH, on Sept. 30 will wrap up Chasing the Sun and launch the main IDWeek program.

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

Two of the three late-breaking abstract sessions coming up this week at IDWeek 2021, an annual scientific meeting on infectious diseases, are filled with the most recent evidence on COVID-19 prevention and treatment.

Adarsh Bhimraj, MD, a vice chair of the conference, said in an interview that attendees will leave the virtual conference with an up-to-date view of what’s promising in the fight against COVID-19 globally and what questions are as yet unanswered.

Researchers will also present findings on promising new antibiotics in the pipeline, stewardship efforts, health disparities, telemedicine advances, and emerging pathogens, but at least a quarter of the program is devoted to COVID-19.

“It’s hard to ignore the elephant in the room,” Dr. Bhimraj said.

Vaccine distribution will be among the hot topics at the global conference, he said, in light of the recent decisions by the Food and Drug Administration and the Centers for Disease Control and Prevention to reserve boosters for those at greatest risk.

Although the United States and other high-resource countries are deciding who should get boosters, only 10% of the developing world has received even a single dose, he noted.

The conference will also present a worldwide view of scientific collaboration to address the COVID pandemic and pandemics yet to come, Dr. Bhimraj said.

He highlighted a talk on Oct. 2, to be delivered by South African human rights attorney and social justice activist Fatima Hassan, called “Global Vaccines and Preventive Care Inequities: Implications and Solutions Beyond the Pandemic.”

The session looks ahead to building systems to share resources and knowledge to end deadly outbreaks with an equitable approach.

“We live in a global village,” Dr. Bhimraj said. “It isn’t just the right thing to do, it’s the pragmatic thing to do.”
 

Controversies in non-COVID diseases

Controversies and new treatments are plentiful in other diseases as well.

• At an HIV session, arguments will be presented regarding the sustainability and practicalities of telemedicine in HIV. Speakers will argue for and against telemedicine as a permanent practice changer for the field.
• In a session on Oct. 1, panelists will discuss pros and cons of information published in preprints versus peer-reviewed journals and how to assess when research findings should lead to practice change.
• Also on Oct. 1, panelists in a symposium will discuss advantages and disadvantages of antifungal treatments for children who have received solid organ transplants.
• Antimicrobial stewardship continues to be a primary topic at IDWeek, this year with additional pandemic challenges. Sessions will address trends in use and diagnostic advances to help in prescribing.
• The pipeline for new antibiotics continues to face barriers regarding production and development. No new classes of antibiotics have been discovered since the 1980s. Pew has that there are too few drugs in development to meet current and anticipated need.
• This year’s program offers a symposium on private-public partnerships to help jump-start development.
• One of the most popular sessions returning this year is “Clinical Trials That Will Change Your Practice,” Dr. Bhimraj said. This year, that session will be reserved for non-COVID infectious disease research. Presenters will summarize the findings of top work published in the past year.

Around-the-world COVID view

Again this year, global experts will present a round-the-clock session called “Chasing the Sun” the day before the main sessions. It will include updates on COVID throughout the world. Barney Graham, MD, PhD, deputy director of the National Institutes of Health’s Vaccine Research Center, will kick off the program with an address on the future of vaccinology. This will be followed by updates on the state of the disease in Central and South America, Japan, Asia Pacific, India, and Africa.

Sandra Harwood, IDWeek conference secretariat, who proposed the idea for the first Chasing the Sun session last year, said in an interview that the updates will highlight particular COVID challenges experienced in various countries.

For example, leaders of India’s session will address why a potentially fatal fungal disease struck many COVID-19 patients in that country. Japan’s update will include how Olympic organizers planned for and dealt with the virus’s threat in Tokyo.

Ms. Harwood said that all the COVID sessions in Chasing the Sun and throughout the program will be free to clinicians inside and outside the conference, thanks to a grant from the CDC.

An address by CDC Director Rochelle Walensky, MD, MPH, on Sept. 30 will wrap up Chasing the Sun and launch the main IDWeek program.

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

Two of the three late-breaking abstract sessions coming up this week at IDWeek 2021, an annual scientific meeting on infectious diseases, are filled with the most recent evidence on COVID-19 prevention and treatment.

Adarsh Bhimraj, MD, a vice chair of the conference, said in an interview that attendees will leave the virtual conference with an up-to-date view of what’s promising in the fight against COVID-19 globally and what questions are as yet unanswered.

Researchers will also present findings on promising new antibiotics in the pipeline, stewardship efforts, health disparities, telemedicine advances, and emerging pathogens, but at least a quarter of the program is devoted to COVID-19.

“It’s hard to ignore the elephant in the room,” Dr. Bhimraj said.

Vaccine distribution will be among the hot topics at the global conference, he said, in light of the recent decisions by the Food and Drug Administration and the Centers for Disease Control and Prevention to reserve boosters for those at greatest risk.

Although the United States and other high-resource countries are deciding who should get boosters, only 10% of the developing world has received even a single dose, he noted.

The conference will also present a worldwide view of scientific collaboration to address the COVID pandemic and pandemics yet to come, Dr. Bhimraj said.

He highlighted a talk on Oct. 2, to be delivered by South African human rights attorney and social justice activist Fatima Hassan, called “Global Vaccines and Preventive Care Inequities: Implications and Solutions Beyond the Pandemic.”

The session looks ahead to building systems to share resources and knowledge to end deadly outbreaks with an equitable approach.

“We live in a global village,” Dr. Bhimraj said. “It isn’t just the right thing to do, it’s the pragmatic thing to do.”
 

Controversies in non-COVID diseases

Controversies and new treatments are plentiful in other diseases as well.

• At an HIV session, arguments will be presented regarding the sustainability and practicalities of telemedicine in HIV. Speakers will argue for and against telemedicine as a permanent practice changer for the field.
• In a session on Oct. 1, panelists will discuss pros and cons of information published in preprints versus peer-reviewed journals and how to assess when research findings should lead to practice change.
• Also on Oct. 1, panelists in a symposium will discuss advantages and disadvantages of antifungal treatments for children who have received solid organ transplants.
• Antimicrobial stewardship continues to be a primary topic at IDWeek, this year with additional pandemic challenges. Sessions will address trends in use and diagnostic advances to help in prescribing.
• The pipeline for new antibiotics continues to face barriers regarding production and development. No new classes of antibiotics have been discovered since the 1980s. Pew has that there are too few drugs in development to meet current and anticipated need.
• This year’s program offers a symposium on private-public partnerships to help jump-start development.
• One of the most popular sessions returning this year is “Clinical Trials That Will Change Your Practice,” Dr. Bhimraj said. This year, that session will be reserved for non-COVID infectious disease research. Presenters will summarize the findings of top work published in the past year.

Around-the-world COVID view

Again this year, global experts will present a round-the-clock session called “Chasing the Sun” the day before the main sessions. It will include updates on COVID throughout the world. Barney Graham, MD, PhD, deputy director of the National Institutes of Health’s Vaccine Research Center, will kick off the program with an address on the future of vaccinology. This will be followed by updates on the state of the disease in Central and South America, Japan, Asia Pacific, India, and Africa.

Sandra Harwood, IDWeek conference secretariat, who proposed the idea for the first Chasing the Sun session last year, said in an interview that the updates will highlight particular COVID challenges experienced in various countries.

For example, leaders of India’s session will address why a potentially fatal fungal disease struck many COVID-19 patients in that country. Japan’s update will include how Olympic organizers planned for and dealt with the virus’s threat in Tokyo.

Ms. Harwood said that all the COVID sessions in Chasing the Sun and throughout the program will be free to clinicians inside and outside the conference, thanks to a grant from the CDC.

An address by CDC Director Rochelle Walensky, MD, MPH, on Sept. 30 will wrap up Chasing the Sun and launch the main IDWeek program.

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

The proportion of patients who obtained an opioid prescription for hydrocodone after Mohs micrographic surgery fell by 21.7% between 2011 and 2020, while the use of tramadol increased by 26.3% between 2009 and 2020, according to a cross-sectional analysis of national insurance claims data.

The findings suggest that dermatologic surgeons generally understood opioid prescription risks and public health warnings about the opioid epidemic, corresponding study author Surya A. Veerabagu said in an interview.

“The frequency of opioid prescriptions after Mohs surgery went up a little bit from 2009 to 2011, but then it subsequently decreased,” said Ms. Veerabagu, a 4th-year student at Tulane University, New Orleans. “It very much correlates with the overarching opioid trends of the time. From 2010 to 2015, research questioning the safety of opioids increased and in 2012, national prescriptions claims for opioids began to decrease. More media outlets voiced concerns over the growing opioid epidemic, as well.”

As she and her associates noted in their study, published online Sept. 22 in JAMA Dermatology, sales of opioids skyrocketed, increasing by 400% from 1999 to 2011, while prescription opioid–related deaths exceeded deaths caused by heroin and cocaine combined.

“In 2016, the U.S. Department of Health and Human Services declared the opioid epidemic a public health emergency, and the Centers for Disease Control and Prevention released guidelines to curtail unnecessary opioid prescriptions,” they wrote. “Unfortunately, overdose deaths involving prescription opioids continued to increase even after these measures.”

The researchers drew from Optum Clinformatics Data Mart (Optum CDM), a nationally representative insurance claims database, and limited the analysis to 358,012 adults who underwent Mohs surgery and obtained an opioid prescription within 2 days of surgery in the United States from Jan. 1, 2009, to June 1, 2020. They found that 34.6% of patients underwent Mohs surgery with opioid claims in 2009. This rose to a peak of 39.6% in 2011, then decreased annually to a rate of 11.7% in 2020.

The four opioids obtained most during the study period were hydrocodone (55%), codeine (16.3%), oxycodone (12%), and tramadol (11.6%). However, over time, the proportion of patients who obtained hydrocodone fell 21.7% from a peak of 67.1% in 2011 to 45.4% in 2020, while the proportion of patients who obtained tramadol – generally recognized as a safer option – increased 26.3% from a low of 1.6% in 2009 to 27.9% in 2020.

“The switch from very addictive opioids like hydrocodone and oxycodone to weaker opioids like tramadol was fascinating to see,” said Ms. Veerabagu, who conducted the study during her research fellowship in the department of dermatology at the University of Pennsylvania, Philadelphia. “I remember at first thinking I had coded the data wrong. I reviewed the results with the team to ensure it was correct. We noticed that propoxyphene prescriptions suddenly dropped to 0% in 2011.” She found that the FDA warning in 2010 and recall regarding the use of propoxyphene because of cardiotoxicity correlated with her data, which, “in addition to the thorough review, convinced me that my coding was correct.” Prior to 2011, propoxyphene constituted 28% of prescriptions in 2009 and 24% of prescriptions in 2010.

In an interview, Maryam M. Asgari, MD, professor of dermatology at Harvard Medical School, Boston, said that the findings support recent opioid prescription recommendations following Mohs and other dermatologic procedures from professional societies including those from the American College of Mohs Surgery.

“More awareness has been raised in the past decade regarding the opioid epidemic and the rise of opioid abuse and deaths,” she said. “There has been increased scrutiny on procedures and prescribing of opioids post procedures.”

State-led efforts to lower the number of opioid prescriptions also play a role. For example, in 2016, Massachusetts launched the Massachusetts Prescription Awareness Tool (MassPAT), which imposes a 7-day limit on first-time prescriptions of opioids to patients and mandates that all prescribers check the prescription drug monitoring program before prescribing schedule II or III substances.

“The MassPAT system also gives you quarterly data on how your opioid prescriptions compare with those of your peers within your specialty and subspecialty,” Dr. Asgari said. “If you’re an outlier, I think that quickly leads you to change your prescribing patterns.”

Dr. Asgari noted that most opioids prescribed in the study by Ms. Veerabagu and colleagues were for cancers that arose on the head and neck. “There is still a perception among providers that cancers that arise in those anatomic sites can potentially cause more discomfort for the patient,” she said. “So, knowing more about the degree of pain among the head and neck cases would be an area of knowledge that would help provider behavior down the line.”

Ms. Veerabagu acknowledged certain limitations of the study, including the fact that unfilled prescriptions could not be accounted for, nor could opioids not taken or those obtained without a prescription. “We cannot survey patients in insurance claims database studies, so we have no way of knowing if everyone’s pain was adequately controlled from 2009 to 2020,” she said.

“The main takeaway message is to make sure doctors and patients share an open dialogue,” she added. “Informing patients of the major pros and cons of the appropriate postoperative pain management options available, including opioids’ addiction potential, is crucial. We hope our study adds to the larger continuing conversation of opioid usage within dermatology.”

The study’s senior author was Cerrene N. Giordano, MD, of the department of dermatology at the Hospital of the University of Pennsylvania, Philadelphia. Coauthor Jeremy R. Etzkorn, MD, is supported by a Dermatology Foundation Career Development Award in Dermatologic Surgery; coauthor Megan H. Noe, MD, MPH, reported receiving grants from Boehringer Ingelheim outside the submitted work. Another coauthor, Thuzar M. Shin, MD, PhD, reported receiving grants from Regeneron outside the submitted work. Dr. Asgari disclosed that she has received support from the Melanoma Research Alliance. She also contributes a chapter on skin cancer to UpToDate, for which she receives royalties.

[email protected]

The proportion of patients who obtained an opioid prescription for hydrocodone after Mohs micrographic surgery fell by 21.7% between 2011 and 2020, while the use of tramadol increased by 26.3% between 2009 and 2020, according to a cross-sectional analysis of national insurance claims data.

The findings suggest that dermatologic surgeons generally understood opioid prescription risks and public health warnings about the opioid epidemic, corresponding study author Surya A. Veerabagu said in an interview.

“The frequency of opioid prescriptions after Mohs surgery went up a little bit from 2009 to 2011, but then it subsequently decreased,” said Ms. Veerabagu, a 4th-year student at Tulane University, New Orleans. “It very much correlates with the overarching opioid trends of the time. From 2010 to 2015, research questioning the safety of opioids increased and in 2012, national prescriptions claims for opioids began to decrease. More media outlets voiced concerns over the growing opioid epidemic, as well.”

As she and her associates noted in their study, published online Sept. 22 in JAMA Dermatology, sales of opioids skyrocketed, increasing by 400% from 1999 to 2011, while prescription opioid–related deaths exceeded deaths caused by heroin and cocaine combined.

“In 2016, the U.S. Department of Health and Human Services declared the opioid epidemic a public health emergency, and the Centers for Disease Control and Prevention released guidelines to curtail unnecessary opioid prescriptions,” they wrote. “Unfortunately, overdose deaths involving prescription opioids continued to increase even after these measures.”

The researchers drew from Optum Clinformatics Data Mart (Optum CDM), a nationally representative insurance claims database, and limited the analysis to 358,012 adults who underwent Mohs surgery and obtained an opioid prescription within 2 days of surgery in the United States from Jan. 1, 2009, to June 1, 2020. They found that 34.6% of patients underwent Mohs surgery with opioid claims in 2009. This rose to a peak of 39.6% in 2011, then decreased annually to a rate of 11.7% in 2020.

The four opioids obtained most during the study period were hydrocodone (55%), codeine (16.3%), oxycodone (12%), and tramadol (11.6%). However, over time, the proportion of patients who obtained hydrocodone fell 21.7% from a peak of 67.1% in 2011 to 45.4% in 2020, while the proportion of patients who obtained tramadol – generally recognized as a safer option – increased 26.3% from a low of 1.6% in 2009 to 27.9% in 2020.

“The switch from very addictive opioids like hydrocodone and oxycodone to weaker opioids like tramadol was fascinating to see,” said Ms. Veerabagu, who conducted the study during her research fellowship in the department of dermatology at the University of Pennsylvania, Philadelphia. “I remember at first thinking I had coded the data wrong. I reviewed the results with the team to ensure it was correct. We noticed that propoxyphene prescriptions suddenly dropped to 0% in 2011.” She found that the FDA warning in 2010 and recall regarding the use of propoxyphene because of cardiotoxicity correlated with her data, which, “in addition to the thorough review, convinced me that my coding was correct.” Prior to 2011, propoxyphene constituted 28% of prescriptions in 2009 and 24% of prescriptions in 2010.

In an interview, Maryam M. Asgari, MD, professor of dermatology at Harvard Medical School, Boston, said that the findings support recent opioid prescription recommendations following Mohs and other dermatologic procedures from professional societies including those from the American College of Mohs Surgery.

“More awareness has been raised in the past decade regarding the opioid epidemic and the rise of opioid abuse and deaths,” she said. “There has been increased scrutiny on procedures and prescribing of opioids post procedures.”

State-led efforts to lower the number of opioid prescriptions also play a role. For example, in 2016, Massachusetts launched the Massachusetts Prescription Awareness Tool (MassPAT), which imposes a 7-day limit on first-time prescriptions of opioids to patients and mandates that all prescribers check the prescription drug monitoring program before prescribing schedule II or III substances.

“The MassPAT system also gives you quarterly data on how your opioid prescriptions compare with those of your peers within your specialty and subspecialty,” Dr. Asgari said. “If you’re an outlier, I think that quickly leads you to change your prescribing patterns.”

Dr. Asgari noted that most opioids prescribed in the study by Ms. Veerabagu and colleagues were for cancers that arose on the head and neck. “There is still a perception among providers that cancers that arise in those anatomic sites can potentially cause more discomfort for the patient,” she said. “So, knowing more about the degree of pain among the head and neck cases would be an area of knowledge that would help provider behavior down the line.”

Ms. Veerabagu acknowledged certain limitations of the study, including the fact that unfilled prescriptions could not be accounted for, nor could opioids not taken or those obtained without a prescription. “We cannot survey patients in insurance claims database studies, so we have no way of knowing if everyone’s pain was adequately controlled from 2009 to 2020,” she said.

“The main takeaway message is to make sure doctors and patients share an open dialogue,” she added. “Informing patients of the major pros and cons of the appropriate postoperative pain management options available, including opioids’ addiction potential, is crucial. We hope our study adds to the larger continuing conversation of opioid usage within dermatology.”

The study’s senior author was Cerrene N. Giordano, MD, of the department of dermatology at the Hospital of the University of Pennsylvania, Philadelphia. Coauthor Jeremy R. Etzkorn, MD, is supported by a Dermatology Foundation Career Development Award in Dermatologic Surgery; coauthor Megan H. Noe, MD, MPH, reported receiving grants from Boehringer Ingelheim outside the submitted work. Another coauthor, Thuzar M. Shin, MD, PhD, reported receiving grants from Regeneron outside the submitted work. Dr. Asgari disclosed that she has received support from the Melanoma Research Alliance. She also contributes a chapter on skin cancer to UpToDate, for which she receives royalties.

[email protected]

The proportion of patients who obtained an opioid prescription for hydrocodone after Mohs micrographic surgery fell by 21.7% between 2011 and 2020, while the use of tramadol increased by 26.3% between 2009 and 2020, according to a cross-sectional analysis of national insurance claims data.

The findings suggest that dermatologic surgeons generally understood opioid prescription risks and public health warnings about the opioid epidemic, corresponding study author Surya A. Veerabagu said in an interview.

“The frequency of opioid prescriptions after Mohs surgery went up a little bit from 2009 to 2011, but then it subsequently decreased,” said Ms. Veerabagu, a 4th-year student at Tulane University, New Orleans. “It very much correlates with the overarching opioid trends of the time. From 2010 to 2015, research questioning the safety of opioids increased and in 2012, national prescriptions claims for opioids began to decrease. More media outlets voiced concerns over the growing opioid epidemic, as well.”

As she and her associates noted in their study, published online Sept. 22 in JAMA Dermatology, sales of opioids skyrocketed, increasing by 400% from 1999 to 2011, while prescription opioid–related deaths exceeded deaths caused by heroin and cocaine combined.

“In 2016, the U.S. Department of Health and Human Services declared the opioid epidemic a public health emergency, and the Centers for Disease Control and Prevention released guidelines to curtail unnecessary opioid prescriptions,” they wrote. “Unfortunately, overdose deaths involving prescription opioids continued to increase even after these measures.”

The researchers drew from Optum Clinformatics Data Mart (Optum CDM), a nationally representative insurance claims database, and limited the analysis to 358,012 adults who underwent Mohs surgery and obtained an opioid prescription within 2 days of surgery in the United States from Jan. 1, 2009, to June 1, 2020. They found that 34.6% of patients underwent Mohs surgery with opioid claims in 2009. This rose to a peak of 39.6% in 2011, then decreased annually to a rate of 11.7% in 2020.

The four opioids obtained most during the study period were hydrocodone (55%), codeine (16.3%), oxycodone (12%), and tramadol (11.6%). However, over time, the proportion of patients who obtained hydrocodone fell 21.7% from a peak of 67.1% in 2011 to 45.4% in 2020, while the proportion of patients who obtained tramadol – generally recognized as a safer option – increased 26.3% from a low of 1.6% in 2009 to 27.9% in 2020.

“The switch from very addictive opioids like hydrocodone and oxycodone to weaker opioids like tramadol was fascinating to see,” said Ms. Veerabagu, who conducted the study during her research fellowship in the department of dermatology at the University of Pennsylvania, Philadelphia. “I remember at first thinking I had coded the data wrong. I reviewed the results with the team to ensure it was correct. We noticed that propoxyphene prescriptions suddenly dropped to 0% in 2011.” She found that the FDA warning in 2010 and recall regarding the use of propoxyphene because of cardiotoxicity correlated with her data, which, “in addition to the thorough review, convinced me that my coding was correct.” Prior to 2011, propoxyphene constituted 28% of prescriptions in 2009 and 24% of prescriptions in 2010.

In an interview, Maryam M. Asgari, MD, professor of dermatology at Harvard Medical School, Boston, said that the findings support recent opioid prescription recommendations following Mohs and other dermatologic procedures from professional societies including those from the American College of Mohs Surgery.

“More awareness has been raised in the past decade regarding the opioid epidemic and the rise of opioid abuse and deaths,” she said. “There has been increased scrutiny on procedures and prescribing of opioids post procedures.”

State-led efforts to lower the number of opioid prescriptions also play a role. For example, in 2016, Massachusetts launched the Massachusetts Prescription Awareness Tool (MassPAT), which imposes a 7-day limit on first-time prescriptions of opioids to patients and mandates that all prescribers check the prescription drug monitoring program before prescribing schedule II or III substances.

“The MassPAT system also gives you quarterly data on how your opioid prescriptions compare with those of your peers within your specialty and subspecialty,” Dr. Asgari said. “If you’re an outlier, I think that quickly leads you to change your prescribing patterns.”

Dr. Asgari noted that most opioids prescribed in the study by Ms. Veerabagu and colleagues were for cancers that arose on the head and neck. “There is still a perception among providers that cancers that arise in those anatomic sites can potentially cause more discomfort for the patient,” she said. “So, knowing more about the degree of pain among the head and neck cases would be an area of knowledge that would help provider behavior down the line.”

Ms. Veerabagu acknowledged certain limitations of the study, including the fact that unfilled prescriptions could not be accounted for, nor could opioids not taken or those obtained without a prescription. “We cannot survey patients in insurance claims database studies, so we have no way of knowing if everyone’s pain was adequately controlled from 2009 to 2020,” she said.

“The main takeaway message is to make sure doctors and patients share an open dialogue,” she added. “Informing patients of the major pros and cons of the appropriate postoperative pain management options available, including opioids’ addiction potential, is crucial. We hope our study adds to the larger continuing conversation of opioid usage within dermatology.”

The study’s senior author was Cerrene N. Giordano, MD, of the department of dermatology at the Hospital of the University of Pennsylvania, Philadelphia. Coauthor Jeremy R. Etzkorn, MD, is supported by a Dermatology Foundation Career Development Award in Dermatologic Surgery; coauthor Megan H. Noe, MD, MPH, reported receiving grants from Boehringer Ingelheim outside the submitted work. Another coauthor, Thuzar M. Shin, MD, PhD, reported receiving grants from Regeneron outside the submitted work. Dr. Asgari disclosed that she has received support from the Melanoma Research Alliance. She also contributes a chapter on skin cancer to UpToDate, for which she receives royalties.

[email protected]

A combination of magnetic resonance elastography and blood levels of fibrosis-4 index (MEFIB) outperformed FibroScan-AST (FAST) in determining the presence of significant fibrosis among patients with nonalcoholic fatty liver disease (NAFLD), according to a new prospective cohort analysis.

© parisvas/Thinkstock

Liver fibrosis is the most important prognostic factor for NAFLD, but the invasiveness, propensity for sampling error, and interoperator variability of biopsy have prompted efforts to develop alternatives. FAST, which uses vibration-controlled transient elastography (VCTE), controlled attenuation parameter (CAP), and aspartate aminotransferase levels, and MEFIB have been developed as candidates, but they had not been directly compared in screening. The findings suggest that MEFIB may be a better tool for identifying NAFLD patients at heightened risk of nonalcoholic steatohepatitis (NASH), as well as which patients could be candidates for pharmacotherapy interventions and clinical trials.

Although there are no drugs currently approved for high-risk NAFLD patients, many clinical trials are underway. Patients with stage 2 or higher fibrosis are candidates for clinical trials, but many trials experience a high screening failure rate. A noninvasive method that can identify clinical trial candidates while avoiding liver biopsy would be a welcome addition, Nobuharu Tamaki, MD, PhD, of the NAFLD Research Center, division of gastroenterology and hepatology, department of medicine, at the University of California, San Diego, and colleagues explained in Hepatology.

“We suspect that these are the patients; if there is going to be a drug approved, it will be for this patient population. So it’s important for prognosis, but it’s also important potentially for future treatment with new drugs,” said Zobair Younossi, MD, who was asked to comment on the study.

The researchers examined a cohort of 234 consecutive adults at UCSD and 314 consecutive adults at Yokohama (Japan) City University who underwent liver biopsy, magnetic resonance elastography (MRE), VCTE, and CAP assessment.

Significant fibrosis was found in 29.5% of the UCSD cohort and 66.2% of the Yokohama cohort.* MEFIB had a higher area under the receiver operating characteristic curve than FAST in the UCSD cohort (0.860 vs. 0.757; P = .005) and the Yokohama cohort (0.899 vs. 0.724; P < .001).

When the researchers employed MEFIB as a rule-in criteria (MRE value ≥3.3 kPa and FIB-4 ≥1.6), MEFIB had a positive predictive value of 91.2% in the UCSD cohort and 96.0% in the Yokohama cohort, versus 74.2% and 89.2% for FAST (≥0.67), respectively. Rule-out criteria included MRE less than 3.3 kPa and Fib-4 less than1.6 for MEFIB, as well as FAST of 0.35 or less; with those parameters, negative predictive value for significant fibrosis was 92.8% in the UCSD group and 85.6% in the Yokohama group for MEFIB, and 88.3% and 57.8% for FAST, respectively.

Most existing noninvasive tests do a pretty good job of excluding advanced fibrosis, but they don’t perform as well at identifying those with cirrhosis, according to Dr. Younossi. He added that MEFIB isn’t suitable for general population screening, but rather for case finding, in which it can be used to identify patients who are likely to have high risk for fibrosis. “Nevertheless, it seems like the combination of FIB-4 and MRE has very good performance for identifying and excluding NAFLD patients with moderate to advance fibrosis, at least in the two cohorts that were looked at,” said Dr. Younossi.

However, Dr. Younossi noted some potential limitations to the study. Both cohorts were from referral centers, making it likely that the included patients have higher prevalences of fibrosis than a typical practice patient population, making it important to validate the findings in a real-world setting. The approach also relies on magnetic resonance technology, which is costly and may not be readily available. “We need to potentially find other, simpler noninvasive test combinations that are easier to do than MRE,” said Dr. Younossi.

Several authors disclosed ties with numerous pharmaceutical and device companies, including Pfizer, AstraZeneca, and Siemens. Dr. Younossi has no relevant financial disclosures.

Correction, 1/18/22: An earlier version of this article misstated the percentage of each cohort that had significant fibrosis.

A combination of magnetic resonance elastography and blood levels of fibrosis-4 index (MEFIB) outperformed FibroScan-AST (FAST) in determining the presence of significant fibrosis among patients with nonalcoholic fatty liver disease (NAFLD), according to a new prospective cohort analysis.

© parisvas/Thinkstock

Liver fibrosis is the most important prognostic factor for NAFLD, but the invasiveness, propensity for sampling error, and interoperator variability of biopsy have prompted efforts to develop alternatives. FAST, which uses vibration-controlled transient elastography (VCTE), controlled attenuation parameter (CAP), and aspartate aminotransferase levels, and MEFIB have been developed as candidates, but they had not been directly compared in screening. The findings suggest that MEFIB may be a better tool for identifying NAFLD patients at heightened risk of nonalcoholic steatohepatitis (NASH), as well as which patients could be candidates for pharmacotherapy interventions and clinical trials.

Although there are no drugs currently approved for high-risk NAFLD patients, many clinical trials are underway. Patients with stage 2 or higher fibrosis are candidates for clinical trials, but many trials experience a high screening failure rate. A noninvasive method that can identify clinical trial candidates while avoiding liver biopsy would be a welcome addition, Nobuharu Tamaki, MD, PhD, of the NAFLD Research Center, division of gastroenterology and hepatology, department of medicine, at the University of California, San Diego, and colleagues explained in Hepatology.

“We suspect that these are the patients; if there is going to be a drug approved, it will be for this patient population. So it’s important for prognosis, but it’s also important potentially for future treatment with new drugs,” said Zobair Younossi, MD, who was asked to comment on the study.

The researchers examined a cohort of 234 consecutive adults at UCSD and 314 consecutive adults at Yokohama (Japan) City University who underwent liver biopsy, magnetic resonance elastography (MRE), VCTE, and CAP assessment.

Significant fibrosis was found in 29.5% of the UCSD cohort and 66.2% of the Yokohama cohort.* MEFIB had a higher area under the receiver operating characteristic curve than FAST in the UCSD cohort (0.860 vs. 0.757; P = .005) and the Yokohama cohort (0.899 vs. 0.724; P < .001).

When the researchers employed MEFIB as a rule-in criteria (MRE value ≥3.3 kPa and FIB-4 ≥1.6), MEFIB had a positive predictive value of 91.2% in the UCSD cohort and 96.0% in the Yokohama cohort, versus 74.2% and 89.2% for FAST (≥0.67), respectively. Rule-out criteria included MRE less than 3.3 kPa and Fib-4 less than1.6 for MEFIB, as well as FAST of 0.35 or less; with those parameters, negative predictive value for significant fibrosis was 92.8% in the UCSD group and 85.6% in the Yokohama group for MEFIB, and 88.3% and 57.8% for FAST, respectively.

Most existing noninvasive tests do a pretty good job of excluding advanced fibrosis, but they don’t perform as well at identifying those with cirrhosis, according to Dr. Younossi. He added that MEFIB isn’t suitable for general population screening, but rather for case finding, in which it can be used to identify patients who are likely to have high risk for fibrosis. “Nevertheless, it seems like the combination of FIB-4 and MRE has very good performance for identifying and excluding NAFLD patients with moderate to advance fibrosis, at least in the two cohorts that were looked at,” said Dr. Younossi.

However, Dr. Younossi noted some potential limitations to the study. Both cohorts were from referral centers, making it likely that the included patients have higher prevalences of fibrosis than a typical practice patient population, making it important to validate the findings in a real-world setting. The approach also relies on magnetic resonance technology, which is costly and may not be readily available. “We need to potentially find other, simpler noninvasive test combinations that are easier to do than MRE,” said Dr. Younossi.

Several authors disclosed ties with numerous pharmaceutical and device companies, including Pfizer, AstraZeneca, and Siemens. Dr. Younossi has no relevant financial disclosures.

Correction, 1/18/22: An earlier version of this article misstated the percentage of each cohort that had significant fibrosis.

A combination of magnetic resonance elastography and blood levels of fibrosis-4 index (MEFIB) outperformed FibroScan-AST (FAST) in determining the presence of significant fibrosis among patients with nonalcoholic fatty liver disease (NAFLD), according to a new prospective cohort analysis.

© parisvas/Thinkstock

Liver fibrosis is the most important prognostic factor for NAFLD, but the invasiveness, propensity for sampling error, and interoperator variability of biopsy have prompted efforts to develop alternatives. FAST, which uses vibration-controlled transient elastography (VCTE), controlled attenuation parameter (CAP), and aspartate aminotransferase levels, and MEFIB have been developed as candidates, but they had not been directly compared in screening. The findings suggest that MEFIB may be a better tool for identifying NAFLD patients at heightened risk of nonalcoholic steatohepatitis (NASH), as well as which patients could be candidates for pharmacotherapy interventions and clinical trials.

Although there are no drugs currently approved for high-risk NAFLD patients, many clinical trials are underway. Patients with stage 2 or higher fibrosis are candidates for clinical trials, but many trials experience a high screening failure rate. A noninvasive method that can identify clinical trial candidates while avoiding liver biopsy would be a welcome addition, Nobuharu Tamaki, MD, PhD, of the NAFLD Research Center, division of gastroenterology and hepatology, department of medicine, at the University of California, San Diego, and colleagues explained in Hepatology.

“We suspect that these are the patients; if there is going to be a drug approved, it will be for this patient population. So it’s important for prognosis, but it’s also important potentially for future treatment with new drugs,” said Zobair Younossi, MD, who was asked to comment on the study.

The researchers examined a cohort of 234 consecutive adults at UCSD and 314 consecutive adults at Yokohama (Japan) City University who underwent liver biopsy, magnetic resonance elastography (MRE), VCTE, and CAP assessment.

Significant fibrosis was found in 29.5% of the UCSD cohort and 66.2% of the Yokohama cohort.* MEFIB had a higher area under the receiver operating characteristic curve than FAST in the UCSD cohort (0.860 vs. 0.757; P = .005) and the Yokohama cohort (0.899 vs. 0.724; P < .001).

When the researchers employed MEFIB as a rule-in criteria (MRE value ≥3.3 kPa and FIB-4 ≥1.6), MEFIB had a positive predictive value of 91.2% in the UCSD cohort and 96.0% in the Yokohama cohort, versus 74.2% and 89.2% for FAST (≥0.67), respectively. Rule-out criteria included MRE less than 3.3 kPa and Fib-4 less than1.6 for MEFIB, as well as FAST of 0.35 or less; with those parameters, negative predictive value for significant fibrosis was 92.8% in the UCSD group and 85.6% in the Yokohama group for MEFIB, and 88.3% and 57.8% for FAST, respectively.

Most existing noninvasive tests do a pretty good job of excluding advanced fibrosis, but they don’t perform as well at identifying those with cirrhosis, according to Dr. Younossi. He added that MEFIB isn’t suitable for general population screening, but rather for case finding, in which it can be used to identify patients who are likely to have high risk for fibrosis. “Nevertheless, it seems like the combination of FIB-4 and MRE has very good performance for identifying and excluding NAFLD patients with moderate to advance fibrosis, at least in the two cohorts that were looked at,” said Dr. Younossi.

However, Dr. Younossi noted some potential limitations to the study. Both cohorts were from referral centers, making it likely that the included patients have higher prevalences of fibrosis than a typical practice patient population, making it important to validate the findings in a real-world setting. The approach also relies on magnetic resonance technology, which is costly and may not be readily available. “We need to potentially find other, simpler noninvasive test combinations that are easier to do than MRE,” said Dr. Younossi.

Several authors disclosed ties with numerous pharmaceutical and device companies, including Pfizer, AstraZeneca, and Siemens. Dr. Younossi has no relevant financial disclosures.

Correction, 1/18/22: An earlier version of this article misstated the percentage of each cohort that had significant fibrosis.