Conference Coverage

Having COVID-19 during pregnancy is linked to a significantly increased risk for gestational hypertension and preeclampsia compared with not having COVID-19 while pregnant, according to findings from a retrospective study presented Jan. 28 at the Society for Maternal-Fetal Medicine 2021 Annual Pregnancy Meeting.

“This was not entirely surprising given that inflammation has been implicated in the pathogenesis of both hypertensive disorders of pregnancy and COVID-19 infection and thus may serve to exacerbate each other,” Nigel Madden, MD, a resident physician in the ob.gyn. department at Columbia University, New York. , told this news organization after she presented the results.

Hypertensive disorders of pregnancy occur in 10%-15% of all pregnancies and are the leading cause of maternal and perinatal morbidity and mortality worldwide, Dr. Madden told attendees of the meeting. Although it’s not clear what causes hypertensive diseases in pregnancy generally, “it is possible that the acute inflammatory state of the COVID infection may incite or exacerbate hypertensive disease of pregnancy,” Dr. Madden said.

The researchers conducted a retrospective chart review of 1,715 patients who had a singleton pregnancy and who underwent routine nasal polymerase chain reaction testing at admission to one institution’s labor and delivery department between March and June 2020. The researchers excluded patients who had a history of chronic hypertension.

Overall, 10% of the patients tested positive for COVID-19 (n = 167), and 90% tested negative (n = 1,548). There were several differences at baseline between the groups. Those who tested positive tended to be younger, with an average age of 28, compared with an average age of 31 years for the group that tested negative. The group that tested negative also had a higher proportion of mothers aged 35 and older (P < .01). There were also significant differences in the racial makeup of the groups. Half of those in the COVID-positive group reported “other” for their race. The biggest baseline disparity between the groups was with regard to insurance type: 73% of those who tested positive for COVID-19 used Medicaid; only 36% of patients in the COVID-negative group used Medicaid. Those with private insurance were more likely to test negative (43%) than positive (25%) (P < .01).

The researchers defined gestational hypertension as having a systolic blood pressure greater than or equal to 140 mm Hg or a diastolic blood pressure greater than or equal to 90 mm Hg on two occasions at least 4 hours apart. A preeclampsia diagnosis required elevated blood pressure (using the same definition as for hypertension) as well as proteinuria, characterized by a protein/creatine ratio greater than or equal to 0.3 mg/dL or greater than or equal to 300 mg of protein on a 24-hour urine collection. Preeclampsia with severe features required prespecified laboratory abnormalities, pulmonary edema, or symptoms of headache, vision changes, chest pain, shortness of breath, or right upper quadrant pain.

More than twice as many patients with COVID had a hypertensive disorder of pregnancy (18%) as those who tested negative (8%). The patients who were COVID positive were significantly more likely than those who tested negative to have gestational hypertension and preeclampsia without severe features. Rates of preeclampsia with severe features were not significantly different between the groups.

The severity of hypertensive disease did not differ between the groups. Limitations of the study included its retrospective design, the small number of COVID-positive patients, and the fact that it was conducted at a single institution in New York. However, the study population was diverse, and it was conducted during the height of infections at the epicenter of the COVID-19 pandemic.

“This was a study of great clinical significance,” said Kim Boggess, MD, of the University of North Carolina at Chapel Hill, while moderating the session. “I would argue that you guys in New York are the best poised to answer some of the questions that need to be answered as it relates to the effect of coronavirus infection in pregnancy.”

Dr. Boggess asked whether the study examined associations related to the severity of COVID-19. Only 10 of the patients were symptomatic, Dr. Madden said, and only one of those patients developed preeclampsia with severe features.

Michelle Y. Owens, MD, professor and chief of maternal fetal medicine at the University of Mississippi Medical Center, Jackson, who also moderated the session, said in an interview that the findings call for physicians to remain vigilant about evaluating patients who test positive for COVID-19 for hypertensive disease and disorders.

“Additionally, these women should be educated about hypertensive disorders and the common symptoms to facilitate early diagnosis and treatment when indicated,” Dr. Owens said. “I believe this is of particular interest in those women who are not severely affected by COVID, as these changes may occur while they are undergoing quarantine or being monitored remotely. This amplifies the need for remote assessment or home monitoring of maternal blood pressures.”

Dr. Madden, Dr. Boggess, and Dr. Owens have disclosed no relevant financial relationships.

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

Having COVID-19 during pregnancy is linked to a significantly increased risk for gestational hypertension and preeclampsia compared with not having COVID-19 while pregnant, according to findings from a retrospective study presented Jan. 28 at the Society for Maternal-Fetal Medicine 2021 Annual Pregnancy Meeting.

“This was not entirely surprising given that inflammation has been implicated in the pathogenesis of both hypertensive disorders of pregnancy and COVID-19 infection and thus may serve to exacerbate each other,” Nigel Madden, MD, a resident physician in the ob.gyn. department at Columbia University, New York. , told this news organization after she presented the results.

Hypertensive disorders of pregnancy occur in 10%-15% of all pregnancies and are the leading cause of maternal and perinatal morbidity and mortality worldwide, Dr. Madden told attendees of the meeting. Although it’s not clear what causes hypertensive diseases in pregnancy generally, “it is possible that the acute inflammatory state of the COVID infection may incite or exacerbate hypertensive disease of pregnancy,” Dr. Madden said.

The researchers conducted a retrospective chart review of 1,715 patients who had a singleton pregnancy and who underwent routine nasal polymerase chain reaction testing at admission to one institution’s labor and delivery department between March and June 2020. The researchers excluded patients who had a history of chronic hypertension.

Overall, 10% of the patients tested positive for COVID-19 (n = 167), and 90% tested negative (n = 1,548). There were several differences at baseline between the groups. Those who tested positive tended to be younger, with an average age of 28, compared with an average age of 31 years for the group that tested negative. The group that tested negative also had a higher proportion of mothers aged 35 and older (P < .01). There were also significant differences in the racial makeup of the groups. Half of those in the COVID-positive group reported “other” for their race. The biggest baseline disparity between the groups was with regard to insurance type: 73% of those who tested positive for COVID-19 used Medicaid; only 36% of patients in the COVID-negative group used Medicaid. Those with private insurance were more likely to test negative (43%) than positive (25%) (P < .01).

The researchers defined gestational hypertension as having a systolic blood pressure greater than or equal to 140 mm Hg or a diastolic blood pressure greater than or equal to 90 mm Hg on two occasions at least 4 hours apart. A preeclampsia diagnosis required elevated blood pressure (using the same definition as for hypertension) as well as proteinuria, characterized by a protein/creatine ratio greater than or equal to 0.3 mg/dL or greater than or equal to 300 mg of protein on a 24-hour urine collection. Preeclampsia with severe features required prespecified laboratory abnormalities, pulmonary edema, or symptoms of headache, vision changes, chest pain, shortness of breath, or right upper quadrant pain.

More than twice as many patients with COVID had a hypertensive disorder of pregnancy (18%) as those who tested negative (8%). The patients who were COVID positive were significantly more likely than those who tested negative to have gestational hypertension and preeclampsia without severe features. Rates of preeclampsia with severe features were not significantly different between the groups.

The severity of hypertensive disease did not differ between the groups. Limitations of the study included its retrospective design, the small number of COVID-positive patients, and the fact that it was conducted at a single institution in New York. However, the study population was diverse, and it was conducted during the height of infections at the epicenter of the COVID-19 pandemic.

“This was a study of great clinical significance,” said Kim Boggess, MD, of the University of North Carolina at Chapel Hill, while moderating the session. “I would argue that you guys in New York are the best poised to answer some of the questions that need to be answered as it relates to the effect of coronavirus infection in pregnancy.”

Dr. Boggess asked whether the study examined associations related to the severity of COVID-19. Only 10 of the patients were symptomatic, Dr. Madden said, and only one of those patients developed preeclampsia with severe features.

Michelle Y. Owens, MD, professor and chief of maternal fetal medicine at the University of Mississippi Medical Center, Jackson, who also moderated the session, said in an interview that the findings call for physicians to remain vigilant about evaluating patients who test positive for COVID-19 for hypertensive disease and disorders.

“Additionally, these women should be educated about hypertensive disorders and the common symptoms to facilitate early diagnosis and treatment when indicated,” Dr. Owens said. “I believe this is of particular interest in those women who are not severely affected by COVID, as these changes may occur while they are undergoing quarantine or being monitored remotely. This amplifies the need for remote assessment or home monitoring of maternal blood pressures.”

Dr. Madden, Dr. Boggess, and Dr. Owens have disclosed no relevant financial relationships.

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

Having COVID-19 during pregnancy is linked to a significantly increased risk for gestational hypertension and preeclampsia compared with not having COVID-19 while pregnant, according to findings from a retrospective study presented Jan. 28 at the Society for Maternal-Fetal Medicine 2021 Annual Pregnancy Meeting.

“This was not entirely surprising given that inflammation has been implicated in the pathogenesis of both hypertensive disorders of pregnancy and COVID-19 infection and thus may serve to exacerbate each other,” Nigel Madden, MD, a resident physician in the ob.gyn. department at Columbia University, New York. , told this news organization after she presented the results.

Hypertensive disorders of pregnancy occur in 10%-15% of all pregnancies and are the leading cause of maternal and perinatal morbidity and mortality worldwide, Dr. Madden told attendees of the meeting. Although it’s not clear what causes hypertensive diseases in pregnancy generally, “it is possible that the acute inflammatory state of the COVID infection may incite or exacerbate hypertensive disease of pregnancy,” Dr. Madden said.

The researchers conducted a retrospective chart review of 1,715 patients who had a singleton pregnancy and who underwent routine nasal polymerase chain reaction testing at admission to one institution’s labor and delivery department between March and June 2020. The researchers excluded patients who had a history of chronic hypertension.

Overall, 10% of the patients tested positive for COVID-19 (n = 167), and 90% tested negative (n = 1,548). There were several differences at baseline between the groups. Those who tested positive tended to be younger, with an average age of 28, compared with an average age of 31 years for the group that tested negative. The group that tested negative also had a higher proportion of mothers aged 35 and older (P < .01). There were also significant differences in the racial makeup of the groups. Half of those in the COVID-positive group reported “other” for their race. The biggest baseline disparity between the groups was with regard to insurance type: 73% of those who tested positive for COVID-19 used Medicaid; only 36% of patients in the COVID-negative group used Medicaid. Those with private insurance were more likely to test negative (43%) than positive (25%) (P < .01).

The researchers defined gestational hypertension as having a systolic blood pressure greater than or equal to 140 mm Hg or a diastolic blood pressure greater than or equal to 90 mm Hg on two occasions at least 4 hours apart. A preeclampsia diagnosis required elevated blood pressure (using the same definition as for hypertension) as well as proteinuria, characterized by a protein/creatine ratio greater than or equal to 0.3 mg/dL or greater than or equal to 300 mg of protein on a 24-hour urine collection. Preeclampsia with severe features required prespecified laboratory abnormalities, pulmonary edema, or symptoms of headache, vision changes, chest pain, shortness of breath, or right upper quadrant pain.

More than twice as many patients with COVID had a hypertensive disorder of pregnancy (18%) as those who tested negative (8%). The patients who were COVID positive were significantly more likely than those who tested negative to have gestational hypertension and preeclampsia without severe features. Rates of preeclampsia with severe features were not significantly different between the groups.

The severity of hypertensive disease did not differ between the groups. Limitations of the study included its retrospective design, the small number of COVID-positive patients, and the fact that it was conducted at a single institution in New York. However, the study population was diverse, and it was conducted during the height of infections at the epicenter of the COVID-19 pandemic.

“This was a study of great clinical significance,” said Kim Boggess, MD, of the University of North Carolina at Chapel Hill, while moderating the session. “I would argue that you guys in New York are the best poised to answer some of the questions that need to be answered as it relates to the effect of coronavirus infection in pregnancy.”

Dr. Boggess asked whether the study examined associations related to the severity of COVID-19. Only 10 of the patients were symptomatic, Dr. Madden said, and only one of those patients developed preeclampsia with severe features.

Michelle Y. Owens, MD, professor and chief of maternal fetal medicine at the University of Mississippi Medical Center, Jackson, who also moderated the session, said in an interview that the findings call for physicians to remain vigilant about evaluating patients who test positive for COVID-19 for hypertensive disease and disorders.

“Additionally, these women should be educated about hypertensive disorders and the common symptoms to facilitate early diagnosis and treatment when indicated,” Dr. Owens said. “I believe this is of particular interest in those women who are not severely affected by COVID, as these changes may occur while they are undergoing quarantine or being monitored remotely. This amplifies the need for remote assessment or home monitoring of maternal blood pressures.”

Dr. Madden, Dr. Boggess, and Dr. Owens have disclosed no relevant financial relationships.

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

Even though over-the-counter topical antiperspirants are a common go-to treatment for primary axillary hyperhidrosis, a large survey commissioned by the International Hyperhidrosis Society showed that, while OTC aluminum products are the most recommended, they offer the least satisfaction to patients.

Koldunov/iStock/Getty Images

Of the 1,985 survey respondents who self-identified as having excessive sweating, those who received treatment were most satisfied with injections and least satisfied with prescription and OTC antiperspirants and liposuction. “It’s important to recognize that, while these are not invasive, they’re simple, you need to keep up with it, and they’re really not that effective for primary hyperhidrosis,” Adam Friedman, MD, said during the virtual Orlando Dermatology Aesthetic and Clinical Conference.

A major development came in 2018, when the Food and Drug Administration approved topical glycopyrronium tosylate for the treatment of primary axillary hyperhidrosis in adults and in children as young as age 9. It marked the first topical anticholinergic approved for the condition. Results from the pivotal phase 2 ATMOS-1 and ATMOS-2 randomized, controlled trials found that, after 4 weeks of daily use, 53%-66% of patients reported a 4-point improvement or greater on the ASDD item 2, which is defined as the worst sweating they experienced in a 24-hour period on an 11-point scale.

“Patients want to know: How quickly am I going to see improvement? The answer to this can be central to treatment compliance,” said Dr. Friedman, professor and interim chair of dermatology at the George Washington University, Washington. “We have data showing that 23%-29% of patients using glycopyrronium tosylate met that primary outcome within 1 week of use. So, you can tell patients: ‘Help is on the way. You may see a response relatively soon.’ ”

The most common adverse events in the two trials were dry mouth, which affected 24% of patients, followed by mydriasis (7%), and oropharyngeal pain (6%). He advises patients to apply it once at night. “I tell my patients make this the last thing you do during your nighttime routine,” said Dr. Friedman, who coauthored a case-based clinical algorithm for approaching primary hyperhidrosis patients.

“Open it up, one swipe to the right [underarm], flip it over, one wipe of the left [underarm], toss the towelette, and wash your hands thoroughly. You don’t need to remove axillary hair or occlude the area. I tell them they may find some improvement within one week of daily use, but I give realistic expectations, usually 2-3 weeks. Tell them about the potential for side effects, which certainly can happen,” he said.

Investigators are evaluating how this product could be delivered to other body sites. Dr. Friedman said that he uses glycopyrronium tosylate off label for palmar and plantar hyperhidrosis. He advises patients to rub their hands or feet the cloth until it dries, toss the towelette, apply an occlusive agent like Aquaphor followed by gloves/socks for at least an hour, and then wash their hands or feet. “If they can keep the gloves or socks on overnight, that’s fine, but that’s very rare,” Dr. Friedman added.

“Typically, an hour or 2 of occlusive covering will get the product in where it needs to be. The upside of this product is that it’s noninvasive, there’s minimal irritation, it’s effective, and FDA approved. On the downside, it’s a long-term therapy. This is forever, so cost can be an issue, and you have to think about the anticholinergic effects as well.”

Iontophoresis is a first-line treatment for moderate to severe palmar and plantar hyperhidrosis. It’s also effective for mild hyperhidrosis with limited side effects, but it’s cumbersome, he said, requiring thrice-weekly treatment of each palm or sole for approximately 30 minutes to a controlled electric current at 15-20 mA with tap water.

There are no systemic agents approved for hyperhidrosis, only case reports or small case series. For now, the two commonly used anticholinergics are glycopyrrolate and oxybutynin. Glycopyrrolate comes in 1- and 2-mg capsules. “You can break the tablets easily and it’s pretty cheap, with an estimated cost of 2 mg/day at $756 per year,” Dr. Friedman said. “I typically start patients on 1 mg twice per day for a week, then ask how they’re doing. If they notice improvement, have minimal side effects but think they can do better, then I increase it by 1 mg and reassess. I give them autonomy, and at most, want them to max out at 6 mg per day. There is an oral solution for kids, which can make this a little more accessible.”

He prescribes oxybutynin infrequently but considers it effective. “Most patients respond to 5- to 10-mg/day dosing, but doses up to 15 or 20 mg daily may be required,” he noted.

For persistent flushing with hyperhidrosis, Dr. Friedman typically recommends treatment with clonidine. “I start patients pretty low, sometimes 0.05 mg twice per day.”

For patients who sweat because of social phobias and performance anxiety, he typically recommends treatment with a beta-adrenergic blocker. “These are highly lipophilic, so I advise patients not to take them with food,” he said. “The peak concentration is 1-1.5 hours. Usually, I start at 10 mg and I have people do a test run at home. I also take a baseline blood pressure in the office to make sure they’re not hypotensive.” The use of beta-adrenergic blockers is contraindicated in patients with bradycardia, atrioventricular block, and asthma. They can also exacerbate psoriasis.

On Sept. 20, 2020, Brickell Biotech announced the approval of sofpironium bromide gel, 5%, in Japan for the treatment of primary axillary hyperhidrosis. Sofpironium bromide is an analog of glycopyrrolate “that gets metabolized very quickly in order to limit systemic absorption of the active agent and therefore mitigate side effects,” Dr. Friedman said.

A recently published Japanese study found that 54% of patients with primary axillary hyperhidrosis who received sofpironium bromide experienced a 1- or 2-point improvement on the Hyperhidrosis Disease Severity Scale and a 50% or greater reduction in gravimetric sweat production from baseline to week 6 of treatment, compared with 36% of patients in the control group (P = .003). According to Dr. Friedman, a 15% formulation of this product is being studied in the United States, “but the experience in Japan with the 5% formulation should give us some real-world information about this product,” he said. “Out of the gate, we’re going to know something about how it’s being used.”

Dr. Friedman reported that he serves as a consultant and/or advisor to numerous pharmaceutical companies, including some that produce cannabinoids. He is also a speaker for Regeneron, Abbvie, Novartis, LRP, Dermira, and Brickel Biotech, and has received grants from Pfizer, the Dermatology Foundation, Almirall, and Janssen.

dbrunk@mdedge.com

Even though over-the-counter topical antiperspirants are a common go-to treatment for primary axillary hyperhidrosis, a large survey commissioned by the International Hyperhidrosis Society showed that, while OTC aluminum products are the most recommended, they offer the least satisfaction to patients.

Koldunov/iStock/Getty Images

Of the 1,985 survey respondents who self-identified as having excessive sweating, those who received treatment were most satisfied with injections and least satisfied with prescription and OTC antiperspirants and liposuction. “It’s important to recognize that, while these are not invasive, they’re simple, you need to keep up with it, and they’re really not that effective for primary hyperhidrosis,” Adam Friedman, MD, said during the virtual Orlando Dermatology Aesthetic and Clinical Conference.

A major development came in 2018, when the Food and Drug Administration approved topical glycopyrronium tosylate for the treatment of primary axillary hyperhidrosis in adults and in children as young as age 9. It marked the first topical anticholinergic approved for the condition. Results from the pivotal phase 2 ATMOS-1 and ATMOS-2 randomized, controlled trials found that, after 4 weeks of daily use, 53%-66% of patients reported a 4-point improvement or greater on the ASDD item 2, which is defined as the worst sweating they experienced in a 24-hour period on an 11-point scale.

“Patients want to know: How quickly am I going to see improvement? The answer to this can be central to treatment compliance,” said Dr. Friedman, professor and interim chair of dermatology at the George Washington University, Washington. “We have data showing that 23%-29% of patients using glycopyrronium tosylate met that primary outcome within 1 week of use. So, you can tell patients: ‘Help is on the way. You may see a response relatively soon.’ ”

The most common adverse events in the two trials were dry mouth, which affected 24% of patients, followed by mydriasis (7%), and oropharyngeal pain (6%). He advises patients to apply it once at night. “I tell my patients make this the last thing you do during your nighttime routine,” said Dr. Friedman, who coauthored a case-based clinical algorithm for approaching primary hyperhidrosis patients.

“Open it up, one swipe to the right [underarm], flip it over, one wipe of the left [underarm], toss the towelette, and wash your hands thoroughly. You don’t need to remove axillary hair or occlude the area. I tell them they may find some improvement within one week of daily use, but I give realistic expectations, usually 2-3 weeks. Tell them about the potential for side effects, which certainly can happen,” he said.

Investigators are evaluating how this product could be delivered to other body sites. Dr. Friedman said that he uses glycopyrronium tosylate off label for palmar and plantar hyperhidrosis. He advises patients to rub their hands or feet the cloth until it dries, toss the towelette, apply an occlusive agent like Aquaphor followed by gloves/socks for at least an hour, and then wash their hands or feet. “If they can keep the gloves or socks on overnight, that’s fine, but that’s very rare,” Dr. Friedman added.

“Typically, an hour or 2 of occlusive covering will get the product in where it needs to be. The upside of this product is that it’s noninvasive, there’s minimal irritation, it’s effective, and FDA approved. On the downside, it’s a long-term therapy. This is forever, so cost can be an issue, and you have to think about the anticholinergic effects as well.”

Iontophoresis is a first-line treatment for moderate to severe palmar and plantar hyperhidrosis. It’s also effective for mild hyperhidrosis with limited side effects, but it’s cumbersome, he said, requiring thrice-weekly treatment of each palm or sole for approximately 30 minutes to a controlled electric current at 15-20 mA with tap water.

There are no systemic agents approved for hyperhidrosis, only case reports or small case series. For now, the two commonly used anticholinergics are glycopyrrolate and oxybutynin. Glycopyrrolate comes in 1- and 2-mg capsules. “You can break the tablets easily and it’s pretty cheap, with an estimated cost of 2 mg/day at $756 per year,” Dr. Friedman said. “I typically start patients on 1 mg twice per day for a week, then ask how they’re doing. If they notice improvement, have minimal side effects but think they can do better, then I increase it by 1 mg and reassess. I give them autonomy, and at most, want them to max out at 6 mg per day. There is an oral solution for kids, which can make this a little more accessible.”

He prescribes oxybutynin infrequently but considers it effective. “Most patients respond to 5- to 10-mg/day dosing, but doses up to 15 or 20 mg daily may be required,” he noted.

For persistent flushing with hyperhidrosis, Dr. Friedman typically recommends treatment with clonidine. “I start patients pretty low, sometimes 0.05 mg twice per day.”

For patients who sweat because of social phobias and performance anxiety, he typically recommends treatment with a beta-adrenergic blocker. “These are highly lipophilic, so I advise patients not to take them with food,” he said. “The peak concentration is 1-1.5 hours. Usually, I start at 10 mg and I have people do a test run at home. I also take a baseline blood pressure in the office to make sure they’re not hypotensive.” The use of beta-adrenergic blockers is contraindicated in patients with bradycardia, atrioventricular block, and asthma. They can also exacerbate psoriasis.

On Sept. 20, 2020, Brickell Biotech announced the approval of sofpironium bromide gel, 5%, in Japan for the treatment of primary axillary hyperhidrosis. Sofpironium bromide is an analog of glycopyrrolate “that gets metabolized very quickly in order to limit systemic absorption of the active agent and therefore mitigate side effects,” Dr. Friedman said.

A recently published Japanese study found that 54% of patients with primary axillary hyperhidrosis who received sofpironium bromide experienced a 1- or 2-point improvement on the Hyperhidrosis Disease Severity Scale and a 50% or greater reduction in gravimetric sweat production from baseline to week 6 of treatment, compared with 36% of patients in the control group (P = .003). According to Dr. Friedman, a 15% formulation of this product is being studied in the United States, “but the experience in Japan with the 5% formulation should give us some real-world information about this product,” he said. “Out of the gate, we’re going to know something about how it’s being used.”

Dr. Friedman reported that he serves as a consultant and/or advisor to numerous pharmaceutical companies, including some that produce cannabinoids. He is also a speaker for Regeneron, Abbvie, Novartis, LRP, Dermira, and Brickel Biotech, and has received grants from Pfizer, the Dermatology Foundation, Almirall, and Janssen.

dbrunk@mdedge.com

Even though over-the-counter topical antiperspirants are a common go-to treatment for primary axillary hyperhidrosis, a large survey commissioned by the International Hyperhidrosis Society showed that, while OTC aluminum products are the most recommended, they offer the least satisfaction to patients.

Koldunov/iStock/Getty Images

Of the 1,985 survey respondents who self-identified as having excessive sweating, those who received treatment were most satisfied with injections and least satisfied with prescription and OTC antiperspirants and liposuction. “It’s important to recognize that, while these are not invasive, they’re simple, you need to keep up with it, and they’re really not that effective for primary hyperhidrosis,” Adam Friedman, MD, said during the virtual Orlando Dermatology Aesthetic and Clinical Conference.

A major development came in 2018, when the Food and Drug Administration approved topical glycopyrronium tosylate for the treatment of primary axillary hyperhidrosis in adults and in children as young as age 9. It marked the first topical anticholinergic approved for the condition. Results from the pivotal phase 2 ATMOS-1 and ATMOS-2 randomized, controlled trials found that, after 4 weeks of daily use, 53%-66% of patients reported a 4-point improvement or greater on the ASDD item 2, which is defined as the worst sweating they experienced in a 24-hour period on an 11-point scale.

“Patients want to know: How quickly am I going to see improvement? The answer to this can be central to treatment compliance,” said Dr. Friedman, professor and interim chair of dermatology at the George Washington University, Washington. “We have data showing that 23%-29% of patients using glycopyrronium tosylate met that primary outcome within 1 week of use. So, you can tell patients: ‘Help is on the way. You may see a response relatively soon.’ ”

The most common adverse events in the two trials were dry mouth, which affected 24% of patients, followed by mydriasis (7%), and oropharyngeal pain (6%). He advises patients to apply it once at night. “I tell my patients make this the last thing you do during your nighttime routine,” said Dr. Friedman, who coauthored a case-based clinical algorithm for approaching primary hyperhidrosis patients.

“Open it up, one swipe to the right [underarm], flip it over, one wipe of the left [underarm], toss the towelette, and wash your hands thoroughly. You don’t need to remove axillary hair or occlude the area. I tell them they may find some improvement within one week of daily use, but I give realistic expectations, usually 2-3 weeks. Tell them about the potential for side effects, which certainly can happen,” he said.

Investigators are evaluating how this product could be delivered to other body sites. Dr. Friedman said that he uses glycopyrronium tosylate off label for palmar and plantar hyperhidrosis. He advises patients to rub their hands or feet the cloth until it dries, toss the towelette, apply an occlusive agent like Aquaphor followed by gloves/socks for at least an hour, and then wash their hands or feet. “If they can keep the gloves or socks on overnight, that’s fine, but that’s very rare,” Dr. Friedman added.

“Typically, an hour or 2 of occlusive covering will get the product in where it needs to be. The upside of this product is that it’s noninvasive, there’s minimal irritation, it’s effective, and FDA approved. On the downside, it’s a long-term therapy. This is forever, so cost can be an issue, and you have to think about the anticholinergic effects as well.”

Iontophoresis is a first-line treatment for moderate to severe palmar and plantar hyperhidrosis. It’s also effective for mild hyperhidrosis with limited side effects, but it’s cumbersome, he said, requiring thrice-weekly treatment of each palm or sole for approximately 30 minutes to a controlled electric current at 15-20 mA with tap water.

There are no systemic agents approved for hyperhidrosis, only case reports or small case series. For now, the two commonly used anticholinergics are glycopyrrolate and oxybutynin. Glycopyrrolate comes in 1- and 2-mg capsules. “You can break the tablets easily and it’s pretty cheap, with an estimated cost of 2 mg/day at $756 per year,” Dr. Friedman said. “I typically start patients on 1 mg twice per day for a week, then ask how they’re doing. If they notice improvement, have minimal side effects but think they can do better, then I increase it by 1 mg and reassess. I give them autonomy, and at most, want them to max out at 6 mg per day. There is an oral solution for kids, which can make this a little more accessible.”

He prescribes oxybutynin infrequently but considers it effective. “Most patients respond to 5- to 10-mg/day dosing, but doses up to 15 or 20 mg daily may be required,” he noted.

For persistent flushing with hyperhidrosis, Dr. Friedman typically recommends treatment with clonidine. “I start patients pretty low, sometimes 0.05 mg twice per day.”

For patients who sweat because of social phobias and performance anxiety, he typically recommends treatment with a beta-adrenergic blocker. “These are highly lipophilic, so I advise patients not to take them with food,” he said. “The peak concentration is 1-1.5 hours. Usually, I start at 10 mg and I have people do a test run at home. I also take a baseline blood pressure in the office to make sure they’re not hypotensive.” The use of beta-adrenergic blockers is contraindicated in patients with bradycardia, atrioventricular block, and asthma. They can also exacerbate psoriasis.

On Sept. 20, 2020, Brickell Biotech announced the approval of sofpironium bromide gel, 5%, in Japan for the treatment of primary axillary hyperhidrosis. Sofpironium bromide is an analog of glycopyrrolate “that gets metabolized very quickly in order to limit systemic absorption of the active agent and therefore mitigate side effects,” Dr. Friedman said.

A recently published Japanese study found that 54% of patients with primary axillary hyperhidrosis who received sofpironium bromide experienced a 1- or 2-point improvement on the Hyperhidrosis Disease Severity Scale and a 50% or greater reduction in gravimetric sweat production from baseline to week 6 of treatment, compared with 36% of patients in the control group (P = .003). According to Dr. Friedman, a 15% formulation of this product is being studied in the United States, “but the experience in Japan with the 5% formulation should give us some real-world information about this product,” he said. “Out of the gate, we’re going to know something about how it’s being used.”

Dr. Friedman reported that he serves as a consultant and/or advisor to numerous pharmaceutical companies, including some that produce cannabinoids. He is also a speaker for Regeneron, Abbvie, Novartis, LRP, Dermira, and Brickel Biotech, and has received grants from Pfizer, the Dermatology Foundation, Almirall, and Janssen.

dbrunk@mdedge.com

When a new body contouring device hit the market a few years ago, Nazanin Saedi, MD, had an opportunity to become the first Philadelphia area dermatologist to add the technology to her practice.

“I thought about it, but it didn’t make sense because it wasn’t something important to my patient population,” Dr. Saedi, who directs the Jefferson Laser Surgery and Cosmetic Dermatology Center in Philadelphia, said during the Orlando Dermatology Aesthetic and Clinical Conference. “If I’m not going to have the patient demand and make money from it, then it just doesn’t make sense.”

That experience illustrates one of many pearls of advice that Dr. Saedi shared during a presentation about how to select the best devices when starting your dermatology career: Know your patient population. “Include additional questions in new patient intake forms or online forms to get a sense of what your patient population is interested in,” she advised. “It’s important to understand that before you start to offer new services. Don’t just depend on social media to inform you of the latest trends and what people are doing across the country, because if you purchase something that is very popular on social media for people in New York or L.A., that might not be the best for your practice.”

According to market trends from the American Society for Dermatologic Surgery, 3.5 million laser-, light-, and energy-based procedures were performed in 2018. The top five were for wrinkles (809,166), sun damage (786,856), facial redness (612,367), excess hair (385,466), and melasma (226,007). “Considering this data, when you start a practice, do you buy something for wrinkles or for sun damage right away?” Dr. Saedi asked. “Maybe, but you really need to gauge the market that you practice in. You also want to consider your own skill set and what other dermatologists in your area are offering. If you don’t want to do aggressive procedures, then purchasing a fractional CO₂ laser might not be the best device to start off with. If you are not comfortable dealing with those patients, and potential infections and scarring, then that’s not the right treatment for you. You have to reflect on and identify what you’re comfortable learning and doing and managing.”

Taking time to investigate the services offered by dermatologists and med spas within a few miles of your practice can help you avoid redundancy. “Learn the techniques and the small nuances that will give you a little bit of finesse and make you an expert, to set you apart from other practices,” said Dr. Saedi, who coauthored a chapter in the book, “The Business of Dermatology” (New York: Thieme Medical Publishers, 2020). “I always recommend treating your staff and members of your family, to understand how you can tweak treatments to get the most out of them. Once you treat your staff, they are walking advertisements for what you do. They can also counsel patients, walking them through the healing process after a procedure, so they can know what to expect.”

Appropriate planning and preparation can help avoid acquiring the wrong device, she continued. This includes patient demand, scheduling availability, office space, overhead costs, and the level of staff training. She recommends buying one device at a time and clearing profitability from that device before purchasing another, “because it can be a burden on your practice to have multiple devices all at once,” she said. “You also have to think about the hidden costs – the maintenance and the service contracts. That can exceed $10,000 per year, so consider that when you’re looking to purchase a new device.”

Most people buy laser-, light-, and energy-based devices, but renting for a stretch can help you test the waters without a significant long-term investment. “It might not be the newest laser, but it can help you gauge how much of demand you have for that service to see if you have the patient base to make that larger step of purchasing the device,” she said. “If you buy a new device, make sure that it’s not a counterfeit and that you still have a company service contract. There are many third-party companies selling pre-owned laser aesthetics. Make sure you’re getting the authentic device and that there is some kind of a service contract with the actual manufacturer so they can help fix it when things break down.”

When Dr. Saedi counsels residents about purchasing devices, she typically recommends these five categories in order of preference: vascular, pigment, hair, resurfacing, and body contouring/skin tightening. “If you can cover vascular, pigment, and some kind of textural improvement, you can treat about 90% of aesthetic patients who come through your door,” she said. “Sure, there are some who may want skin tightening that you may not be able to offer with laser resurfacing, but you’re going to be able capture a high patient population by offering these services,” she added. That is why a lot of people end up getting a platform with attachable handpieces, “where you can have one system that is able to offer many different services right off the bat.”

She advised factoring in the amount of time it takes for a procedure and how much time it will take up in a certain room. “That will affect your revenue as well. Are you going to delegate this, or is this something you will do on your own? Take that into account.”

Above all, don’t rush your device purchase. “Some laser company sales representatives may pressure you at the end of a quarter by saying, ‘This is the best deal I’m going to offer you. You’re never going to get a deal like this ever again,’ ” she said. “I advise people to do multiple demos so you’re not just doing a demo for a day and seeing one or two patients. Treat the same patients again a month later. Do multiple demos so that you can feel comfortable. Talk to dermatologists who have the device, who have real experience with it, so you can have the most amount of information moving forward.”

Dr. Saedi reported that she has received equipment from Alma, Aerolase, Cartessa, and Cynosure. She is a consultant to and/or an advisory board member for those companies, as well as for Alastin.

dbrunk@mdedge.com

When a new body contouring device hit the market a few years ago, Nazanin Saedi, MD, had an opportunity to become the first Philadelphia area dermatologist to add the technology to her practice.

“I thought about it, but it didn’t make sense because it wasn’t something important to my patient population,” Dr. Saedi, who directs the Jefferson Laser Surgery and Cosmetic Dermatology Center in Philadelphia, said during the Orlando Dermatology Aesthetic and Clinical Conference. “If I’m not going to have the patient demand and make money from it, then it just doesn’t make sense.”

That experience illustrates one of many pearls of advice that Dr. Saedi shared during a presentation about how to select the best devices when starting your dermatology career: Know your patient population. “Include additional questions in new patient intake forms or online forms to get a sense of what your patient population is interested in,” she advised. “It’s important to understand that before you start to offer new services. Don’t just depend on social media to inform you of the latest trends and what people are doing across the country, because if you purchase something that is very popular on social media for people in New York or L.A., that might not be the best for your practice.”

According to market trends from the American Society for Dermatologic Surgery, 3.5 million laser-, light-, and energy-based procedures were performed in 2018. The top five were for wrinkles (809,166), sun damage (786,856), facial redness (612,367), excess hair (385,466), and melasma (226,007). “Considering this data, when you start a practice, do you buy something for wrinkles or for sun damage right away?” Dr. Saedi asked. “Maybe, but you really need to gauge the market that you practice in. You also want to consider your own skill set and what other dermatologists in your area are offering. If you don’t want to do aggressive procedures, then purchasing a fractional CO₂ laser might not be the best device to start off with. If you are not comfortable dealing with those patients, and potential infections and scarring, then that’s not the right treatment for you. You have to reflect on and identify what you’re comfortable learning and doing and managing.”

Taking time to investigate the services offered by dermatologists and med spas within a few miles of your practice can help you avoid redundancy. “Learn the techniques and the small nuances that will give you a little bit of finesse and make you an expert, to set you apart from other practices,” said Dr. Saedi, who coauthored a chapter in the book, “The Business of Dermatology” (New York: Thieme Medical Publishers, 2020). “I always recommend treating your staff and members of your family, to understand how you can tweak treatments to get the most out of them. Once you treat your staff, they are walking advertisements for what you do. They can also counsel patients, walking them through the healing process after a procedure, so they can know what to expect.”

Appropriate planning and preparation can help avoid acquiring the wrong device, she continued. This includes patient demand, scheduling availability, office space, overhead costs, and the level of staff training. She recommends buying one device at a time and clearing profitability from that device before purchasing another, “because it can be a burden on your practice to have multiple devices all at once,” she said. “You also have to think about the hidden costs – the maintenance and the service contracts. That can exceed $10,000 per year, so consider that when you’re looking to purchase a new device.”

Most people buy laser-, light-, and energy-based devices, but renting for a stretch can help you test the waters without a significant long-term investment. “It might not be the newest laser, but it can help you gauge how much of demand you have for that service to see if you have the patient base to make that larger step of purchasing the device,” she said. “If you buy a new device, make sure that it’s not a counterfeit and that you still have a company service contract. There are many third-party companies selling pre-owned laser aesthetics. Make sure you’re getting the authentic device and that there is some kind of a service contract with the actual manufacturer so they can help fix it when things break down.”

When Dr. Saedi counsels residents about purchasing devices, she typically recommends these five categories in order of preference: vascular, pigment, hair, resurfacing, and body contouring/skin tightening. “If you can cover vascular, pigment, and some kind of textural improvement, you can treat about 90% of aesthetic patients who come through your door,” she said. “Sure, there are some who may want skin tightening that you may not be able to offer with laser resurfacing, but you’re going to be able capture a high patient population by offering these services,” she added. That is why a lot of people end up getting a platform with attachable handpieces, “where you can have one system that is able to offer many different services right off the bat.”

She advised factoring in the amount of time it takes for a procedure and how much time it will take up in a certain room. “That will affect your revenue as well. Are you going to delegate this, or is this something you will do on your own? Take that into account.”

Above all, don’t rush your device purchase. “Some laser company sales representatives may pressure you at the end of a quarter by saying, ‘This is the best deal I’m going to offer you. You’re never going to get a deal like this ever again,’ ” she said. “I advise people to do multiple demos so you’re not just doing a demo for a day and seeing one or two patients. Treat the same patients again a month later. Do multiple demos so that you can feel comfortable. Talk to dermatologists who have the device, who have real experience with it, so you can have the most amount of information moving forward.”

Dr. Saedi reported that she has received equipment from Alma, Aerolase, Cartessa, and Cynosure. She is a consultant to and/or an advisory board member for those companies, as well as for Alastin.

dbrunk@mdedge.com

When a new body contouring device hit the market a few years ago, Nazanin Saedi, MD, had an opportunity to become the first Philadelphia area dermatologist to add the technology to her practice.

“I thought about it, but it didn’t make sense because it wasn’t something important to my patient population,” Dr. Saedi, who directs the Jefferson Laser Surgery and Cosmetic Dermatology Center in Philadelphia, said during the Orlando Dermatology Aesthetic and Clinical Conference. “If I’m not going to have the patient demand and make money from it, then it just doesn’t make sense.”

That experience illustrates one of many pearls of advice that Dr. Saedi shared during a presentation about how to select the best devices when starting your dermatology career: Know your patient population. “Include additional questions in new patient intake forms or online forms to get a sense of what your patient population is interested in,” she advised. “It’s important to understand that before you start to offer new services. Don’t just depend on social media to inform you of the latest trends and what people are doing across the country, because if you purchase something that is very popular on social media for people in New York or L.A., that might not be the best for your practice.”

According to market trends from the American Society for Dermatologic Surgery, 3.5 million laser-, light-, and energy-based procedures were performed in 2018. The top five were for wrinkles (809,166), sun damage (786,856), facial redness (612,367), excess hair (385,466), and melasma (226,007). “Considering this data, when you start a practice, do you buy something for wrinkles or for sun damage right away?” Dr. Saedi asked. “Maybe, but you really need to gauge the market that you practice in. You also want to consider your own skill set and what other dermatologists in your area are offering. If you don’t want to do aggressive procedures, then purchasing a fractional CO₂ laser might not be the best device to start off with. If you are not comfortable dealing with those patients, and potential infections and scarring, then that’s not the right treatment for you. You have to reflect on and identify what you’re comfortable learning and doing and managing.”

Taking time to investigate the services offered by dermatologists and med spas within a few miles of your practice can help you avoid redundancy. “Learn the techniques and the small nuances that will give you a little bit of finesse and make you an expert, to set you apart from other practices,” said Dr. Saedi, who coauthored a chapter in the book, “The Business of Dermatology” (New York: Thieme Medical Publishers, 2020). “I always recommend treating your staff and members of your family, to understand how you can tweak treatments to get the most out of them. Once you treat your staff, they are walking advertisements for what you do. They can also counsel patients, walking them through the healing process after a procedure, so they can know what to expect.”

Appropriate planning and preparation can help avoid acquiring the wrong device, she continued. This includes patient demand, scheduling availability, office space, overhead costs, and the level of staff training. She recommends buying one device at a time and clearing profitability from that device before purchasing another, “because it can be a burden on your practice to have multiple devices all at once,” she said. “You also have to think about the hidden costs – the maintenance and the service contracts. That can exceed $10,000 per year, so consider that when you’re looking to purchase a new device.”

Most people buy laser-, light-, and energy-based devices, but renting for a stretch can help you test the waters without a significant long-term investment. “It might not be the newest laser, but it can help you gauge how much of demand you have for that service to see if you have the patient base to make that larger step of purchasing the device,” she said. “If you buy a new device, make sure that it’s not a counterfeit and that you still have a company service contract. There are many third-party companies selling pre-owned laser aesthetics. Make sure you’re getting the authentic device and that there is some kind of a service contract with the actual manufacturer so they can help fix it when things break down.”

When Dr. Saedi counsels residents about purchasing devices, she typically recommends these five categories in order of preference: vascular, pigment, hair, resurfacing, and body contouring/skin tightening. “If you can cover vascular, pigment, and some kind of textural improvement, you can treat about 90% of aesthetic patients who come through your door,” she said. “Sure, there are some who may want skin tightening that you may not be able to offer with laser resurfacing, but you’re going to be able capture a high patient population by offering these services,” she added. That is why a lot of people end up getting a platform with attachable handpieces, “where you can have one system that is able to offer many different services right off the bat.”

She advised factoring in the amount of time it takes for a procedure and how much time it will take up in a certain room. “That will affect your revenue as well. Are you going to delegate this, or is this something you will do on your own? Take that into account.”

Above all, don’t rush your device purchase. “Some laser company sales representatives may pressure you at the end of a quarter by saying, ‘This is the best deal I’m going to offer you. You’re never going to get a deal like this ever again,’ ” she said. “I advise people to do multiple demos so you’re not just doing a demo for a day and seeing one or two patients. Treat the same patients again a month later. Do multiple demos so that you can feel comfortable. Talk to dermatologists who have the device, who have real experience with it, so you can have the most amount of information moving forward.”

Dr. Saedi reported that she has received equipment from Alma, Aerolase, Cartessa, and Cynosure. She is a consultant to and/or an advisory board member for those companies, as well as for Alastin.

dbrunk@mdedge.com

When a patient presents with a palpable nodule greater than 1 cm in diameter more than 2 weeks after injection of cosmetic filler, sorting out whether the culprit is an infection or an immune reaction is no easy task.

“It’s sometime very difficult to distinguish between the two,” Terrence Keaney, MD, said during the Orlando Dermatology Aesthetic and Clinical Conference. “Classically, an early-onset infection presents as a suppurative mass that’s fluctuant and tender. The challenge with delayed-onset infection is that it often does not tend to be fluctuant. It doesn’t resemble the classic infection you see in regular dermatology practice.”

Dr. Keaney, a dermatologist who is founder and director of SkinDC in Arlington, Va., said that the source of delayed infection could stem from inoculation at the time of injection – primarily via the skin microflora. “There are also rare case reports of mycobacterial infections from watered gauze,” which he said is why he does not use watered gauze in his practice. “This risk reinforces the importance of filler hygiene when you’re using dermal fillers. Isopropyl alcohol is often not enough. A lot of practices use chlorhexidine, avoiding its use around the eyes, to reduce the skin flora. Hypochlorous acid is another safe antiseptic for the face. You also want to be very careful with the needle or cannula tip not to touch your glove and to minimize going in and out of the skin so you’re not seeding the filler with bacteria.”

Other potential sources of a delayed infection described in the literature include a dental abscess, pimple popping, and subsequent injections from acupuncture or hyaluronidase.

When patients present with a nonfluctuant delayed nodule that shows no obvious signs of infection, however, the root cause can stump clinicians. “Is this infectious or not?” asked Dr. Keaney, who is also clinical associate faculty in the department of dermatology at George Washington University, Washington. “Is this a focus on chronic inflammation in response to the product, or is this a collection of chronic bacteria, a biofilm too large to be engulfed by a single cell?” A review of the topic found that three risk factors for the development of biofilms include the surface area of product (large boluses of filler), longevity of the product, and inadequate sterilization technique.

Dr. Keaney said that biofilms create an impaired immune system penetration, which boosts their resistance to antibiotics by 1,000-fold. “These bacteria also have a reduced growth rate, an altered microenvironment, and altered gene expression, so it makes it difficult to clear these biofilms.”

To determine if a delayed nodule is infectious or not, performing a biopsy with polymerase chain reaction (PCR) analysis of tissue samples is ideal. “This would amplify the DNA by electrophoresis,” Dr. Keaney continued. “The problem is, it is often difficult to find labs to perform PCR. Also, you’re likely going to have to biopsy someone’s face. The patient is likely already upset that they have a delayed nodule. Ideally, you would want to avoid having to do a punch biopsy of a patient’s lip, tear trough, temple, or chin. The flip side of the coin is, how do you accurately determine if this is a noninfectious delayed nodule? If it is noninfectious, what is the mechanism of action?”

According to Dr. Keaney, short hyaluronic acid (HA) fragments can act as substrates for cell trafficking and can activate macrophages, dendritic cells, and T cells. In an analysis of immune cell response that used in vitro cell-based assays and was presented during a poster session at the 2018 Anti-Aging Medicine World Congress, researchers found no evidence of inflammatory or immune response to HA used for dermal fillers, regardless of size or formulation. However, physiologic degradation of HA to intermediate/small fragments tends to occur 4-5 months after injection.

“The hypothesis is that proinflammatory HA fragments may prime the immune system for an inflammatory response in the setting of a triggering event,” Dr. Keaney said. “The presence of an inflammatory reaction triggers an immune response to the HA fragments. Possible triggers include infections, dental procedures, and immunizations.”

The American Society for Dermatologic Surgery (ASDS) recently published a guidance regarding SARS-CoV-2 mRNA vaccine side effects in dermal filler patients after three patients developed a reaction to the Moderna vaccine, in clinical trials. “One patient, a 29-year-old, had previous angioedema from a flu vaccine, so the question is: Is it truly a delayed nodule or an immunologic reaction to the ingredients in the vaccine?” Dr. Keaney said. Two other patients, a 51-year-old female and a 46-year-old female, developed facial swelling that were believed to be related to a previous filler injection. Both cases resolved.

“Is the COVID vaccine more of an immunologic trigger than other vaccines?” Dr. Keaney asked. “Are we going to see this more frequently? We may. We just don’t know the denominator. We do not know how many patients in the Moderna or Pfizer vaccine studies had been previously treated with dermal fillers. In patients who have had previous filler treatments, I’m still advising them to get the COVID vaccine if they can.”

Dr. Keaney’s algorithm for treating a delayed nodule that is fluctuant starts with culturing any exudate and beginning a course of empiric antibiotic therapy. “If it’s a nonfluctuant delayed nodule where you’re not sure if it’s related to a biofilm or to an immunologic reaction, there are multiple global consensus papers about this challenging condition in the medical literature,” he said. “Among the papers, there is no consensus treatment, even among consensus panels. They often recommend multiple antibiotic regimens when biofilm is the suspected culprit. For a noninfectious delayed nodule, they recommend prednisone or anti-inflammatory medications. If the nodule is recalcitrant to anti-inflammatory treatments, consider adding empiric antibiotic therapy or dissolve the product.”

In other specialties, the No. 1 priority of a biofilm infection is to get rid of the implant. In orthopedics, for example, the surgeon may remove the artificial joint, Dr. Keaney said. “If that delayed nodule is not responding to comprehensive antibiotic therapy or prednisone anti-inflammatories, you may consider dissolving the filler. The challenge is, there is wide variation in the ability of different hyaluronidase [products] and fillers to dissolve. Another concern is that you may make smaller, more immunogenic HA fragments by dissolving the filler.”

One approach for vascular occlusions introduced by Claudio DeLorenzi, MD, a plastic surgeon in private practice in Kitchener, Ontario, is to dissolve dermal fillers with high-dose pulsed hyaluronidase using up to 1,500 IU every hour. “In the U.S., hyaluronidase comes in 150-200-unit sizes,” Dr. Keaney said. “In my practice, it’s not enough to have one bottle of hyaluronidase. You need around 15-20 bottles to be able to treat for a vascular incident, but if you have a delayed nodule you may also have to use high doses of hyaluronidase.”

Dr. Keaney reported that he is a consultant to and/or an advisory board member for several pharmaceutical companies.

dbrunk@mdedge.com

When a patient presents with a palpable nodule greater than 1 cm in diameter more than 2 weeks after injection of cosmetic filler, sorting out whether the culprit is an infection or an immune reaction is no easy task.

“It’s sometime very difficult to distinguish between the two,” Terrence Keaney, MD, said during the Orlando Dermatology Aesthetic and Clinical Conference. “Classically, an early-onset infection presents as a suppurative mass that’s fluctuant and tender. The challenge with delayed-onset infection is that it often does not tend to be fluctuant. It doesn’t resemble the classic infection you see in regular dermatology practice.”

Dr. Keaney, a dermatologist who is founder and director of SkinDC in Arlington, Va., said that the source of delayed infection could stem from inoculation at the time of injection – primarily via the skin microflora. “There are also rare case reports of mycobacterial infections from watered gauze,” which he said is why he does not use watered gauze in his practice. “This risk reinforces the importance of filler hygiene when you’re using dermal fillers. Isopropyl alcohol is often not enough. A lot of practices use chlorhexidine, avoiding its use around the eyes, to reduce the skin flora. Hypochlorous acid is another safe antiseptic for the face. You also want to be very careful with the needle or cannula tip not to touch your glove and to minimize going in and out of the skin so you’re not seeding the filler with bacteria.”

Other potential sources of a delayed infection described in the literature include a dental abscess, pimple popping, and subsequent injections from acupuncture or hyaluronidase.

When patients present with a nonfluctuant delayed nodule that shows no obvious signs of infection, however, the root cause can stump clinicians. “Is this infectious or not?” asked Dr. Keaney, who is also clinical associate faculty in the department of dermatology at George Washington University, Washington. “Is this a focus on chronic inflammation in response to the product, or is this a collection of chronic bacteria, a biofilm too large to be engulfed by a single cell?” A review of the topic found that three risk factors for the development of biofilms include the surface area of product (large boluses of filler), longevity of the product, and inadequate sterilization technique.

Dr. Keaney said that biofilms create an impaired immune system penetration, which boosts their resistance to antibiotics by 1,000-fold. “These bacteria also have a reduced growth rate, an altered microenvironment, and altered gene expression, so it makes it difficult to clear these biofilms.”

To determine if a delayed nodule is infectious or not, performing a biopsy with polymerase chain reaction (PCR) analysis of tissue samples is ideal. “This would amplify the DNA by electrophoresis,” Dr. Keaney continued. “The problem is, it is often difficult to find labs to perform PCR. Also, you’re likely going to have to biopsy someone’s face. The patient is likely already upset that they have a delayed nodule. Ideally, you would want to avoid having to do a punch biopsy of a patient’s lip, tear trough, temple, or chin. The flip side of the coin is, how do you accurately determine if this is a noninfectious delayed nodule? If it is noninfectious, what is the mechanism of action?”

According to Dr. Keaney, short hyaluronic acid (HA) fragments can act as substrates for cell trafficking and can activate macrophages, dendritic cells, and T cells. In an analysis of immune cell response that used in vitro cell-based assays and was presented during a poster session at the 2018 Anti-Aging Medicine World Congress, researchers found no evidence of inflammatory or immune response to HA used for dermal fillers, regardless of size or formulation. However, physiologic degradation of HA to intermediate/small fragments tends to occur 4-5 months after injection.

“The hypothesis is that proinflammatory HA fragments may prime the immune system for an inflammatory response in the setting of a triggering event,” Dr. Keaney said. “The presence of an inflammatory reaction triggers an immune response to the HA fragments. Possible triggers include infections, dental procedures, and immunizations.”

The American Society for Dermatologic Surgery (ASDS) recently published a guidance regarding SARS-CoV-2 mRNA vaccine side effects in dermal filler patients after three patients developed a reaction to the Moderna vaccine, in clinical trials. “One patient, a 29-year-old, had previous angioedema from a flu vaccine, so the question is: Is it truly a delayed nodule or an immunologic reaction to the ingredients in the vaccine?” Dr. Keaney said. Two other patients, a 51-year-old female and a 46-year-old female, developed facial swelling that were believed to be related to a previous filler injection. Both cases resolved.

“Is the COVID vaccine more of an immunologic trigger than other vaccines?” Dr. Keaney asked. “Are we going to see this more frequently? We may. We just don’t know the denominator. We do not know how many patients in the Moderna or Pfizer vaccine studies had been previously treated with dermal fillers. In patients who have had previous filler treatments, I’m still advising them to get the COVID vaccine if they can.”

Dr. Keaney’s algorithm for treating a delayed nodule that is fluctuant starts with culturing any exudate and beginning a course of empiric antibiotic therapy. “If it’s a nonfluctuant delayed nodule where you’re not sure if it’s related to a biofilm or to an immunologic reaction, there are multiple global consensus papers about this challenging condition in the medical literature,” he said. “Among the papers, there is no consensus treatment, even among consensus panels. They often recommend multiple antibiotic regimens when biofilm is the suspected culprit. For a noninfectious delayed nodule, they recommend prednisone or anti-inflammatory medications. If the nodule is recalcitrant to anti-inflammatory treatments, consider adding empiric antibiotic therapy or dissolve the product.”

In other specialties, the No. 1 priority of a biofilm infection is to get rid of the implant. In orthopedics, for example, the surgeon may remove the artificial joint, Dr. Keaney said. “If that delayed nodule is not responding to comprehensive antibiotic therapy or prednisone anti-inflammatories, you may consider dissolving the filler. The challenge is, there is wide variation in the ability of different hyaluronidase [products] and fillers to dissolve. Another concern is that you may make smaller, more immunogenic HA fragments by dissolving the filler.”

One approach for vascular occlusions introduced by Claudio DeLorenzi, MD, a plastic surgeon in private practice in Kitchener, Ontario, is to dissolve dermal fillers with high-dose pulsed hyaluronidase using up to 1,500 IU every hour. “In the U.S., hyaluronidase comes in 150-200-unit sizes,” Dr. Keaney said. “In my practice, it’s not enough to have one bottle of hyaluronidase. You need around 15-20 bottles to be able to treat for a vascular incident, but if you have a delayed nodule you may also have to use high doses of hyaluronidase.”

Dr. Keaney reported that he is a consultant to and/or an advisory board member for several pharmaceutical companies.

dbrunk@mdedge.com

When a patient presents with a palpable nodule greater than 1 cm in diameter more than 2 weeks after injection of cosmetic filler, sorting out whether the culprit is an infection or an immune reaction is no easy task.

“It’s sometime very difficult to distinguish between the two,” Terrence Keaney, MD, said during the Orlando Dermatology Aesthetic and Clinical Conference. “Classically, an early-onset infection presents as a suppurative mass that’s fluctuant and tender. The challenge with delayed-onset infection is that it often does not tend to be fluctuant. It doesn’t resemble the classic infection you see in regular dermatology practice.”

Dr. Keaney, a dermatologist who is founder and director of SkinDC in Arlington, Va., said that the source of delayed infection could stem from inoculation at the time of injection – primarily via the skin microflora. “There are also rare case reports of mycobacterial infections from watered gauze,” which he said is why he does not use watered gauze in his practice. “This risk reinforces the importance of filler hygiene when you’re using dermal fillers. Isopropyl alcohol is often not enough. A lot of practices use chlorhexidine, avoiding its use around the eyes, to reduce the skin flora. Hypochlorous acid is another safe antiseptic for the face. You also want to be very careful with the needle or cannula tip not to touch your glove and to minimize going in and out of the skin so you’re not seeding the filler with bacteria.”

Other potential sources of a delayed infection described in the literature include a dental abscess, pimple popping, and subsequent injections from acupuncture or hyaluronidase.

When patients present with a nonfluctuant delayed nodule that shows no obvious signs of infection, however, the root cause can stump clinicians. “Is this infectious or not?” asked Dr. Keaney, who is also clinical associate faculty in the department of dermatology at George Washington University, Washington. “Is this a focus on chronic inflammation in response to the product, or is this a collection of chronic bacteria, a biofilm too large to be engulfed by a single cell?” A review of the topic found that three risk factors for the development of biofilms include the surface area of product (large boluses of filler), longevity of the product, and inadequate sterilization technique.

Dr. Keaney said that biofilms create an impaired immune system penetration, which boosts their resistance to antibiotics by 1,000-fold. “These bacteria also have a reduced growth rate, an altered microenvironment, and altered gene expression, so it makes it difficult to clear these biofilms.”

To determine if a delayed nodule is infectious or not, performing a biopsy with polymerase chain reaction (PCR) analysis of tissue samples is ideal. “This would amplify the DNA by electrophoresis,” Dr. Keaney continued. “The problem is, it is often difficult to find labs to perform PCR. Also, you’re likely going to have to biopsy someone’s face. The patient is likely already upset that they have a delayed nodule. Ideally, you would want to avoid having to do a punch biopsy of a patient’s lip, tear trough, temple, or chin. The flip side of the coin is, how do you accurately determine if this is a noninfectious delayed nodule? If it is noninfectious, what is the mechanism of action?”

According to Dr. Keaney, short hyaluronic acid (HA) fragments can act as substrates for cell trafficking and can activate macrophages, dendritic cells, and T cells. In an analysis of immune cell response that used in vitro cell-based assays and was presented during a poster session at the 2018 Anti-Aging Medicine World Congress, researchers found no evidence of inflammatory or immune response to HA used for dermal fillers, regardless of size or formulation. However, physiologic degradation of HA to intermediate/small fragments tends to occur 4-5 months after injection.

“The hypothesis is that proinflammatory HA fragments may prime the immune system for an inflammatory response in the setting of a triggering event,” Dr. Keaney said. “The presence of an inflammatory reaction triggers an immune response to the HA fragments. Possible triggers include infections, dental procedures, and immunizations.”

The American Society for Dermatologic Surgery (ASDS) recently published a guidance regarding SARS-CoV-2 mRNA vaccine side effects in dermal filler patients after three patients developed a reaction to the Moderna vaccine, in clinical trials. “One patient, a 29-year-old, had previous angioedema from a flu vaccine, so the question is: Is it truly a delayed nodule or an immunologic reaction to the ingredients in the vaccine?” Dr. Keaney said. Two other patients, a 51-year-old female and a 46-year-old female, developed facial swelling that were believed to be related to a previous filler injection. Both cases resolved.

“Is the COVID vaccine more of an immunologic trigger than other vaccines?” Dr. Keaney asked. “Are we going to see this more frequently? We may. We just don’t know the denominator. We do not know how many patients in the Moderna or Pfizer vaccine studies had been previously treated with dermal fillers. In patients who have had previous filler treatments, I’m still advising them to get the COVID vaccine if they can.”

Dr. Keaney’s algorithm for treating a delayed nodule that is fluctuant starts with culturing any exudate and beginning a course of empiric antibiotic therapy. “If it’s a nonfluctuant delayed nodule where you’re not sure if it’s related to a biofilm or to an immunologic reaction, there are multiple global consensus papers about this challenging condition in the medical literature,” he said. “Among the papers, there is no consensus treatment, even among consensus panels. They often recommend multiple antibiotic regimens when biofilm is the suspected culprit. For a noninfectious delayed nodule, they recommend prednisone or anti-inflammatory medications. If the nodule is recalcitrant to anti-inflammatory treatments, consider adding empiric antibiotic therapy or dissolve the product.”

In other specialties, the No. 1 priority of a biofilm infection is to get rid of the implant. In orthopedics, for example, the surgeon may remove the artificial joint, Dr. Keaney said. “If that delayed nodule is not responding to comprehensive antibiotic therapy or prednisone anti-inflammatories, you may consider dissolving the filler. The challenge is, there is wide variation in the ability of different hyaluronidase [products] and fillers to dissolve. Another concern is that you may make smaller, more immunogenic HA fragments by dissolving the filler.”

One approach for vascular occlusions introduced by Claudio DeLorenzi, MD, a plastic surgeon in private practice in Kitchener, Ontario, is to dissolve dermal fillers with high-dose pulsed hyaluronidase using up to 1,500 IU every hour. “In the U.S., hyaluronidase comes in 150-200-unit sizes,” Dr. Keaney said. “In my practice, it’s not enough to have one bottle of hyaluronidase. You need around 15-20 bottles to be able to treat for a vascular incident, but if you have a delayed nodule you may also have to use high doses of hyaluronidase.”

Dr. Keaney reported that he is a consultant to and/or an advisory board member for several pharmaceutical companies.

dbrunk@mdedge.com

Cardiovascular disease and related risk factors can be common among male breast cancer patients, suggests a small study in this rare malignancy.

Among 24 male breast cancer patients evaluated over a decade in the Washington area, 88% were obese or overweight, 58% had hypertension, and 54% had hyperlipidemia.

Tachyarrhythmia existed in 8% of the men before cancer treatment and developed in 13% during treatment.

Two patients had preexisting heart failure, two patients developed the disease after treatment, and another two patients experienced a decline in left ventricular ejection fraction during the course of their cancer treatment.

“Our hope is that treating male breast cancer patients becomes a multidisciplinary approach where oncologists recruit their cardio-oncologist counterparts to mitigate cardiovascular risk factors, so patients live a long and healthy life after cancer treatment,” said Michael Ibrahim, one of the study authors and a 4th-year medical student at Georgetown University in Washington.

The data were presented Jan. 25 as part of the American College of Cardiology’s Advancing the Cardiovascular Care of the Oncology Patient virtual course, which is hosting live sessions Feb. 5-6.

Although the association between cardiovascular disease and breast cancer is well documented in female breast cancer patients, there is little evidence in their male counterparts, especially African Americans, Mr. Ibrahim noted.

To provide some context, Mr. Ibrahim highlighted a 2018 report in nearly 3,500 female breast cancer patients, ages 40-79, in whom 52% were obese/overweight, 35% had hypertension, and 28% had hyperlipidemia.

Diabetes was present in 7.5% of the women, which was roughly equivalent to the 8% found among the men, Mr. Ibrahim said. The men were of similar age (38-79 years), with 42% being African American, 29% White, 4% Hispanic, and 25% another ethnicity.

Importantly, half of the men had a family history of breast cancer, and two were positive for a mutation in the BRCA gene.

A 2017 in-depth review of male breast cancer cites advancing age, hormonal imbalance, radiation exposure, and family history of breast cancer as key risk factors for the development of the disease, but the “most relevant risk factor” is a mutation in the BRCA2 gene.

Male breast cancer accounts for less than 1% of all breast cancers, but the incidence is rising and, in some patient groups, reaching 15% over their lifetimes, the paper notes. Additionally, these patients are at special risk for developing a second cancer.

Remarkably, 25% of men in the D.C. cohort were diagnosed with a second primary malignancy, 13% a third primary cancer, and 4% a fourth primary cancer, Mr. Ibrahim reported. “This goes to show that male breast cancer patients should routinely undergo cancer screening,” he said.

The initial diagnosis was invasive ductal carcinoma in 79% of the men, with the remaining ductal carcinoma in situ. All patients underwent mastectomy, 17% had anthracycline chemotherapy, 8% received HER2-targeted therapy, 16% had radiation, and 71% received hormone therapy.

In terms of cardiovascular management, statins were the most prescribed medication (46%), followed by antiplatelet therapy (42%) and angiotensin-converting enzyme inhibitors/angiotensin-receptor blockers (38%).

An implantable cardioverter defibrillator/pacemaker was the most common intervention (16%), followed by bypass surgery in 8% and coronary angioplasty in 4%.

Mr. Ibrahim noted that the study was limited by the small sample size and that further research is needed to understand the risk of preexisting cardiovascular disease on long-term outcomes as well as the cardiotoxic effects of chemoradiation in male breast cancer patients.

In a statement, Mr. Ibrahim reiterated the need for a multidisciplinary cancer care team to evaluate patients’ cardiovascular risk prior to and through cancer treatment.

“On a more personal level, cancer patients are already surprised by their cancer diagnosis,” he added. “Similar to the pretreatment consultation with radiation oncology, breast surgery, and medical oncology, an upfront cardiovascular risk assessment provides greater comfort and further minimizes psychological surprise with cardiovascular complications going into cancer treatment.”

The authors have disclosed no relevant financial relationships.

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

Cardiovascular disease and related risk factors can be common among male breast cancer patients, suggests a small study in this rare malignancy.

Among 24 male breast cancer patients evaluated over a decade in the Washington area, 88% were obese or overweight, 58% had hypertension, and 54% had hyperlipidemia.

Tachyarrhythmia existed in 8% of the men before cancer treatment and developed in 13% during treatment.

Two patients had preexisting heart failure, two patients developed the disease after treatment, and another two patients experienced a decline in left ventricular ejection fraction during the course of their cancer treatment.

“Our hope is that treating male breast cancer patients becomes a multidisciplinary approach where oncologists recruit their cardio-oncologist counterparts to mitigate cardiovascular risk factors, so patients live a long and healthy life after cancer treatment,” said Michael Ibrahim, one of the study authors and a 4th-year medical student at Georgetown University in Washington.

The data were presented Jan. 25 as part of the American College of Cardiology’s Advancing the Cardiovascular Care of the Oncology Patient virtual course, which is hosting live sessions Feb. 5-6.

Although the association between cardiovascular disease and breast cancer is well documented in female breast cancer patients, there is little evidence in their male counterparts, especially African Americans, Mr. Ibrahim noted.

To provide some context, Mr. Ibrahim highlighted a 2018 report in nearly 3,500 female breast cancer patients, ages 40-79, in whom 52% were obese/overweight, 35% had hypertension, and 28% had hyperlipidemia.

Diabetes was present in 7.5% of the women, which was roughly equivalent to the 8% found among the men, Mr. Ibrahim said. The men were of similar age (38-79 years), with 42% being African American, 29% White, 4% Hispanic, and 25% another ethnicity.

Importantly, half of the men had a family history of breast cancer, and two were positive for a mutation in the BRCA gene.

A 2017 in-depth review of male breast cancer cites advancing age, hormonal imbalance, radiation exposure, and family history of breast cancer as key risk factors for the development of the disease, but the “most relevant risk factor” is a mutation in the BRCA2 gene.

Male breast cancer accounts for less than 1% of all breast cancers, but the incidence is rising and, in some patient groups, reaching 15% over their lifetimes, the paper notes. Additionally, these patients are at special risk for developing a second cancer.

Remarkably, 25% of men in the D.C. cohort were diagnosed with a second primary malignancy, 13% a third primary cancer, and 4% a fourth primary cancer, Mr. Ibrahim reported. “This goes to show that male breast cancer patients should routinely undergo cancer screening,” he said.

The initial diagnosis was invasive ductal carcinoma in 79% of the men, with the remaining ductal carcinoma in situ. All patients underwent mastectomy, 17% had anthracycline chemotherapy, 8% received HER2-targeted therapy, 16% had radiation, and 71% received hormone therapy.

In terms of cardiovascular management, statins were the most prescribed medication (46%), followed by antiplatelet therapy (42%) and angiotensin-converting enzyme inhibitors/angiotensin-receptor blockers (38%).

An implantable cardioverter defibrillator/pacemaker was the most common intervention (16%), followed by bypass surgery in 8% and coronary angioplasty in 4%.

Mr. Ibrahim noted that the study was limited by the small sample size and that further research is needed to understand the risk of preexisting cardiovascular disease on long-term outcomes as well as the cardiotoxic effects of chemoradiation in male breast cancer patients.

In a statement, Mr. Ibrahim reiterated the need for a multidisciplinary cancer care team to evaluate patients’ cardiovascular risk prior to and through cancer treatment.

“On a more personal level, cancer patients are already surprised by their cancer diagnosis,” he added. “Similar to the pretreatment consultation with radiation oncology, breast surgery, and medical oncology, an upfront cardiovascular risk assessment provides greater comfort and further minimizes psychological surprise with cardiovascular complications going into cancer treatment.”

The authors have disclosed no relevant financial relationships.

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

Cardiovascular disease and related risk factors can be common among male breast cancer patients, suggests a small study in this rare malignancy.

Among 24 male breast cancer patients evaluated over a decade in the Washington area, 88% were obese or overweight, 58% had hypertension, and 54% had hyperlipidemia.

Tachyarrhythmia existed in 8% of the men before cancer treatment and developed in 13% during treatment.

Two patients had preexisting heart failure, two patients developed the disease after treatment, and another two patients experienced a decline in left ventricular ejection fraction during the course of their cancer treatment.

“Our hope is that treating male breast cancer patients becomes a multidisciplinary approach where oncologists recruit their cardio-oncologist counterparts to mitigate cardiovascular risk factors, so patients live a long and healthy life after cancer treatment,” said Michael Ibrahim, one of the study authors and a 4th-year medical student at Georgetown University in Washington.

The data were presented Jan. 25 as part of the American College of Cardiology’s Advancing the Cardiovascular Care of the Oncology Patient virtual course, which is hosting live sessions Feb. 5-6.

Although the association between cardiovascular disease and breast cancer is well documented in female breast cancer patients, there is little evidence in their male counterparts, especially African Americans, Mr. Ibrahim noted.

To provide some context, Mr. Ibrahim highlighted a 2018 report in nearly 3,500 female breast cancer patients, ages 40-79, in whom 52% were obese/overweight, 35% had hypertension, and 28% had hyperlipidemia.

Diabetes was present in 7.5% of the women, which was roughly equivalent to the 8% found among the men, Mr. Ibrahim said. The men were of similar age (38-79 years), with 42% being African American, 29% White, 4% Hispanic, and 25% another ethnicity.

Importantly, half of the men had a family history of breast cancer, and two were positive for a mutation in the BRCA gene.

A 2017 in-depth review of male breast cancer cites advancing age, hormonal imbalance, radiation exposure, and family history of breast cancer as key risk factors for the development of the disease, but the “most relevant risk factor” is a mutation in the BRCA2 gene.

Male breast cancer accounts for less than 1% of all breast cancers, but the incidence is rising and, in some patient groups, reaching 15% over their lifetimes, the paper notes. Additionally, these patients are at special risk for developing a second cancer.

Remarkably, 25% of men in the D.C. cohort were diagnosed with a second primary malignancy, 13% a third primary cancer, and 4% a fourth primary cancer, Mr. Ibrahim reported. “This goes to show that male breast cancer patients should routinely undergo cancer screening,” he said.

The initial diagnosis was invasive ductal carcinoma in 79% of the men, with the remaining ductal carcinoma in situ. All patients underwent mastectomy, 17% had anthracycline chemotherapy, 8% received HER2-targeted therapy, 16% had radiation, and 71% received hormone therapy.

In terms of cardiovascular management, statins were the most prescribed medication (46%), followed by antiplatelet therapy (42%) and angiotensin-converting enzyme inhibitors/angiotensin-receptor blockers (38%).

An implantable cardioverter defibrillator/pacemaker was the most common intervention (16%), followed by bypass surgery in 8% and coronary angioplasty in 4%.

Mr. Ibrahim noted that the study was limited by the small sample size and that further research is needed to understand the risk of preexisting cardiovascular disease on long-term outcomes as well as the cardiotoxic effects of chemoradiation in male breast cancer patients.

In a statement, Mr. Ibrahim reiterated the need for a multidisciplinary cancer care team to evaluate patients’ cardiovascular risk prior to and through cancer treatment.

“On a more personal level, cancer patients are already surprised by their cancer diagnosis,” he added. “Similar to the pretreatment consultation with radiation oncology, breast surgery, and medical oncology, an upfront cardiovascular risk assessment provides greater comfort and further minimizes psychological surprise with cardiovascular complications going into cancer treatment.”

The authors have disclosed no relevant financial relationships.

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

A new study links the COVID-19 pandemic to decreased lung cancer diagnoses, changes in disease severity, and worsened outcomes for patients with lung cancer.

The two-center study showed a 38% decrease in new lung cancer diagnoses during the pandemic. Patients diagnosed with non–small cell lung cancer (NSCLC) during the pandemic had more severe disease than patients diagnosed prepandemic, but cases of SCLC were not more severe during the pandemic. Still, the 30-day mortality rate nearly doubled for both NSCLC and SCLC patients during the pandemic.

“The prioritization of the health care system towards COVID-19 patients has led to drastic changes in cancer management that could interfere with the initial diagnosis of lung cancer, resulting in delayed treatment and worse outcomes,” said Roxana Reyes, MD, of Hospital Clínic de Barcelona. “Delay of cancer treatment is associated with increased mortality.”

Dr. Reyes and colleagues conducted a retrospective study of the impact of COVID-19 on the incidence of new lung cancer cases, disease severity, and clinical outcomes. Dr. Reyes reported the group’s findings at the 2020 World Conference on Lung Cancer (Abstract 3700), which was rescheduled for January 2021.
 

Study details

Dr. Reyes and colleagues compared data from two tertiary hospitals in Spain in the first 6 months of 2020 with data from the same period in 2019. Spain was one of the countries most affected by COVID-19 during the first wave of the pandemic.

The study’s primary endpoint was differences by period in the number of new lung cancer cases and disease severity. A secondary endpoint was 30-day mortality rate by period and histology.

The study included 162 patients newly diagnosed with lung cancer – 100 diagnosed before the pandemic began and 62 diagnosed during the pandemic. Overall, 68% of patients had NSCLC, and 32% had SCLC.

Baseline characteristics were similar between the prepandemic and pandemic groups, except for the proportion of nonsmokers. Twice as many patients diagnosed during the pandemic were nonsmokers (16% vs. 8%).
 

Differences by time period and subtype

During the pandemic, there was a 38% reduction in all lung cancer diagnoses, a 36% reduction in NSCLC diagnoses, and a 42% reduction in SCLC diagnoses.

Respiratory symptoms were more common during the pandemic for both NSCLC (30% vs. 23%) and SCLC (32% vs. 24%).

Cases of NSCLC diagnosed during the pandemic were more severe, but SCLC cases were not.

In the NSCLC cohort, symptomatic disease was more common during the pandemic (74% vs. 63%), as were advanced disease (58% vs. 46%), more than two metastatic sites (16% vs. 12%), oncologic emergencies (7% vs. 3%), hospitalization (21% vs. 18%), and death during hospitalization (44% vs. 17%).

For SCLC, symptomatic disease was less common during the pandemic (74% vs. 79%), as were advanced disease (52% vs. 67%), more than two metastatic sites (26% vs. 36%), oncologic emergencies (5% vs. 12%), hospitalization (21% vs. 33%), and death during hospitalization (0% vs. 18%).

Nevertheless, the 30-day mortality rate almost doubled during the pandemic for both NSCLC (49% vs. 25%) and SCLC (32% vs. 18%).

For both subtypes together, the median overall survival was 6.7 months during the pandemic and 7.9 months before the pandemic.
 

Implications and next steps

“In our descriptive study, lung cancer diagnosis is being affected during the COVID-19 pandemic,” Dr. Reyes said. “Fewer new lung cancer cases were diagnosed during COVID-19.”

Some patients with acute respiratory infections who tested negative for COVID-19 during the first 6 months of the pandemic may have had undiagnosed lung cancer, noted Matthew Peters, MD, of Concord Repatriation General Hospital and Macquarie University Hospital, both in Sydney, who was not involved in this study.

“They receive a negative result and think their problem is reduced but wonder why they still have a cough,” Dr. Peters said. “The various lockdowns and social distancing reduced the diagnosis of respiratory viral illnesses that often result in an accidental diagnosis of lung cancer. As time goes by, we will recapture harvesting of accidental diagnosis of lung cancer and provide curative treatments.”

Dr. Reyes emphasized that strategies for maintaining cancer diagnoses need to be implemented during the pandemic. She also noted that this study is ongoing, with the goal of assessing the long-term impact of COVID-19.

Dr. Reyes disclosed relationships with Roche, Bristol-Myers Squibb, and Merck Sharp & Dohme. She did not disclose funding for this study. Dr. Peters disclosed relationships with Amgen, AstraZeneca, Boehringer Ingelheim, Bristol-Myers Squibb, Eli Lilly, Merck, Novartis, Pfizer, Roche, and Takeda.

A new study links the COVID-19 pandemic to decreased lung cancer diagnoses, changes in disease severity, and worsened outcomes for patients with lung cancer.

The two-center study showed a 38% decrease in new lung cancer diagnoses during the pandemic. Patients diagnosed with non–small cell lung cancer (NSCLC) during the pandemic had more severe disease than patients diagnosed prepandemic, but cases of SCLC were not more severe during the pandemic. Still, the 30-day mortality rate nearly doubled for both NSCLC and SCLC patients during the pandemic.

“The prioritization of the health care system towards COVID-19 patients has led to drastic changes in cancer management that could interfere with the initial diagnosis of lung cancer, resulting in delayed treatment and worse outcomes,” said Roxana Reyes, MD, of Hospital Clínic de Barcelona. “Delay of cancer treatment is associated with increased mortality.”

Dr. Reyes and colleagues conducted a retrospective study of the impact of COVID-19 on the incidence of new lung cancer cases, disease severity, and clinical outcomes. Dr. Reyes reported the group’s findings at the 2020 World Conference on Lung Cancer (Abstract 3700), which was rescheduled for January 2021.
 

Study details

Dr. Reyes and colleagues compared data from two tertiary hospitals in Spain in the first 6 months of 2020 with data from the same period in 2019. Spain was one of the countries most affected by COVID-19 during the first wave of the pandemic.

The study’s primary endpoint was differences by period in the number of new lung cancer cases and disease severity. A secondary endpoint was 30-day mortality rate by period and histology.

The study included 162 patients newly diagnosed with lung cancer – 100 diagnosed before the pandemic began and 62 diagnosed during the pandemic. Overall, 68% of patients had NSCLC, and 32% had SCLC.

Baseline characteristics were similar between the prepandemic and pandemic groups, except for the proportion of nonsmokers. Twice as many patients diagnosed during the pandemic were nonsmokers (16% vs. 8%).
 

Differences by time period and subtype

During the pandemic, there was a 38% reduction in all lung cancer diagnoses, a 36% reduction in NSCLC diagnoses, and a 42% reduction in SCLC diagnoses.

Respiratory symptoms were more common during the pandemic for both NSCLC (30% vs. 23%) and SCLC (32% vs. 24%).

Cases of NSCLC diagnosed during the pandemic were more severe, but SCLC cases were not.

In the NSCLC cohort, symptomatic disease was more common during the pandemic (74% vs. 63%), as were advanced disease (58% vs. 46%), more than two metastatic sites (16% vs. 12%), oncologic emergencies (7% vs. 3%), hospitalization (21% vs. 18%), and death during hospitalization (44% vs. 17%).

For SCLC, symptomatic disease was less common during the pandemic (74% vs. 79%), as were advanced disease (52% vs. 67%), more than two metastatic sites (26% vs. 36%), oncologic emergencies (5% vs. 12%), hospitalization (21% vs. 33%), and death during hospitalization (0% vs. 18%).

Nevertheless, the 30-day mortality rate almost doubled during the pandemic for both NSCLC (49% vs. 25%) and SCLC (32% vs. 18%).

For both subtypes together, the median overall survival was 6.7 months during the pandemic and 7.9 months before the pandemic.
 

Implications and next steps

“In our descriptive study, lung cancer diagnosis is being affected during the COVID-19 pandemic,” Dr. Reyes said. “Fewer new lung cancer cases were diagnosed during COVID-19.”

Some patients with acute respiratory infections who tested negative for COVID-19 during the first 6 months of the pandemic may have had undiagnosed lung cancer, noted Matthew Peters, MD, of Concord Repatriation General Hospital and Macquarie University Hospital, both in Sydney, who was not involved in this study.

“They receive a negative result and think their problem is reduced but wonder why they still have a cough,” Dr. Peters said. “The various lockdowns and social distancing reduced the diagnosis of respiratory viral illnesses that often result in an accidental diagnosis of lung cancer. As time goes by, we will recapture harvesting of accidental diagnosis of lung cancer and provide curative treatments.”

Dr. Reyes emphasized that strategies for maintaining cancer diagnoses need to be implemented during the pandemic. She also noted that this study is ongoing, with the goal of assessing the long-term impact of COVID-19.

Dr. Reyes disclosed relationships with Roche, Bristol-Myers Squibb, and Merck Sharp & Dohme. She did not disclose funding for this study. Dr. Peters disclosed relationships with Amgen, AstraZeneca, Boehringer Ingelheim, Bristol-Myers Squibb, Eli Lilly, Merck, Novartis, Pfizer, Roche, and Takeda.

A new study links the COVID-19 pandemic to decreased lung cancer diagnoses, changes in disease severity, and worsened outcomes for patients with lung cancer.

The two-center study showed a 38% decrease in new lung cancer diagnoses during the pandemic. Patients diagnosed with non–small cell lung cancer (NSCLC) during the pandemic had more severe disease than patients diagnosed prepandemic, but cases of SCLC were not more severe during the pandemic. Still, the 30-day mortality rate nearly doubled for both NSCLC and SCLC patients during the pandemic.

“The prioritization of the health care system towards COVID-19 patients has led to drastic changes in cancer management that could interfere with the initial diagnosis of lung cancer, resulting in delayed treatment and worse outcomes,” said Roxana Reyes, MD, of Hospital Clínic de Barcelona. “Delay of cancer treatment is associated with increased mortality.”

Dr. Reyes and colleagues conducted a retrospective study of the impact of COVID-19 on the incidence of new lung cancer cases, disease severity, and clinical outcomes. Dr. Reyes reported the group’s findings at the 2020 World Conference on Lung Cancer (Abstract 3700), which was rescheduled for January 2021.
 

Study details

Dr. Reyes and colleagues compared data from two tertiary hospitals in Spain in the first 6 months of 2020 with data from the same period in 2019. Spain was one of the countries most affected by COVID-19 during the first wave of the pandemic.

The study’s primary endpoint was differences by period in the number of new lung cancer cases and disease severity. A secondary endpoint was 30-day mortality rate by period and histology.

The study included 162 patients newly diagnosed with lung cancer – 100 diagnosed before the pandemic began and 62 diagnosed during the pandemic. Overall, 68% of patients had NSCLC, and 32% had SCLC.

Baseline characteristics were similar between the prepandemic and pandemic groups, except for the proportion of nonsmokers. Twice as many patients diagnosed during the pandemic were nonsmokers (16% vs. 8%).
 

Differences by time period and subtype

During the pandemic, there was a 38% reduction in all lung cancer diagnoses, a 36% reduction in NSCLC diagnoses, and a 42% reduction in SCLC diagnoses.

Respiratory symptoms were more common during the pandemic for both NSCLC (30% vs. 23%) and SCLC (32% vs. 24%).

Cases of NSCLC diagnosed during the pandemic were more severe, but SCLC cases were not.

In the NSCLC cohort, symptomatic disease was more common during the pandemic (74% vs. 63%), as were advanced disease (58% vs. 46%), more than two metastatic sites (16% vs. 12%), oncologic emergencies (7% vs. 3%), hospitalization (21% vs. 18%), and death during hospitalization (44% vs. 17%).

For SCLC, symptomatic disease was less common during the pandemic (74% vs. 79%), as were advanced disease (52% vs. 67%), more than two metastatic sites (26% vs. 36%), oncologic emergencies (5% vs. 12%), hospitalization (21% vs. 33%), and death during hospitalization (0% vs. 18%).

Nevertheless, the 30-day mortality rate almost doubled during the pandemic for both NSCLC (49% vs. 25%) and SCLC (32% vs. 18%).

For both subtypes together, the median overall survival was 6.7 months during the pandemic and 7.9 months before the pandemic.
 

Implications and next steps

“In our descriptive study, lung cancer diagnosis is being affected during the COVID-19 pandemic,” Dr. Reyes said. “Fewer new lung cancer cases were diagnosed during COVID-19.”

Some patients with acute respiratory infections who tested negative for COVID-19 during the first 6 months of the pandemic may have had undiagnosed lung cancer, noted Matthew Peters, MD, of Concord Repatriation General Hospital and Macquarie University Hospital, both in Sydney, who was not involved in this study.

“They receive a negative result and think their problem is reduced but wonder why they still have a cough,” Dr. Peters said. “The various lockdowns and social distancing reduced the diagnosis of respiratory viral illnesses that often result in an accidental diagnosis of lung cancer. As time goes by, we will recapture harvesting of accidental diagnosis of lung cancer and provide curative treatments.”

Dr. Reyes emphasized that strategies for maintaining cancer diagnoses need to be implemented during the pandemic. She also noted that this study is ongoing, with the goal of assessing the long-term impact of COVID-19.

Dr. Reyes disclosed relationships with Roche, Bristol-Myers Squibb, and Merck Sharp & Dohme. She did not disclose funding for this study. Dr. Peters disclosed relationships with Amgen, AstraZeneca, Boehringer Ingelheim, Bristol-Myers Squibb, Eli Lilly, Merck, Novartis, Pfizer, Roche, and Takeda.

Delaying surgical reconstruction of fistula structures until after patients with hidradenitis suppurativa (HS) have been on adalimumab for a minimum of 6 months transforms primary wound closure into a highly attractive option, a pilot study suggests.

“Our experience suggests that under the effects of treatment with adalimumab, wound healing disorders with primary wound closure occur less often. And primary wound closure offers advantages over secondary wound healing: shorter length of inpatient stay, lower morbidity, fewer functional problems, and better quality of life,” Gefion Girbig, MD, said at the annual congress of the European Academy of Dermatology and Venereology.

She noted that primary wound closure following surgery for HS is controversial. For example, current German guidelines recommend complete surgical excision of HS lesions, followed by secondary wound healing; the guidelines advise against primary wound closure. But those guidelines were issued back in 2012, years before adalimumab (Humira) achieved regulatory approval as the first and to date only medication indicated for treatment of HS.

Experts agree that while adalimumab has been a difference maker for many patients with HS, surgery is still often necessary. And many surgeons prefer secondary wound healing in HS. That’s because healing by first intention has historically often resulted in complications involving wound healing disorders and infection. These complications necessitate loosening of the primary closure to permit further wound healing by second intention, with a resultant prolonged healing time, explained Dr. Girbig, of the Institute for Health Sciences Research in Dermatology and Nursing at University Medical Center Hamburg-Eppendorf (Germany).

She and her coinvestigators hypothesized that the disordered wound healing is a consequence of the underlying inflammatory disease that lies at the core of HS, and that quelling the inflammation with adalimumab for at least 6 months before performing surgery with primary closure while the anti-TNF therapy continues would reduce the incidence of wound healing disorders.

This was borne out in the group’s small observational pilot study. It included 10 patients with HS who underwent surgery only after at least 6 months on adalimumab. Six had surgery for axillary HS and four for inguinal disease. Only 2 of the 10 developed a wound healing disorder. Both had surgical reconstruction in the inguinal area. Neither case involved infection. Surgical management entailed opening part of the suture to allow simultaneous secondary wound closure.

This 20% incidence of disordered wound healing when primary closure was carried out while systemic inflammation was controlled via adalimumab is markedly lower than rates reported using primary closure without adalimumab. Dr. Girbig and her coinvestigators are now conducting a larger controlled study to confirm their findings.

She reported having no financial conflicts regarding her study.

bjancin@mdedge.com

Delaying surgical reconstruction of fistula structures until after patients with hidradenitis suppurativa (HS) have been on adalimumab for a minimum of 6 months transforms primary wound closure into a highly attractive option, a pilot study suggests.

“Our experience suggests that under the effects of treatment with adalimumab, wound healing disorders with primary wound closure occur less often. And primary wound closure offers advantages over secondary wound healing: shorter length of inpatient stay, lower morbidity, fewer functional problems, and better quality of life,” Gefion Girbig, MD, said at the annual congress of the European Academy of Dermatology and Venereology.

She noted that primary wound closure following surgery for HS is controversial. For example, current German guidelines recommend complete surgical excision of HS lesions, followed by secondary wound healing; the guidelines advise against primary wound closure. But those guidelines were issued back in 2012, years before adalimumab (Humira) achieved regulatory approval as the first and to date only medication indicated for treatment of HS.

Experts agree that while adalimumab has been a difference maker for many patients with HS, surgery is still often necessary. And many surgeons prefer secondary wound healing in HS. That’s because healing by first intention has historically often resulted in complications involving wound healing disorders and infection. These complications necessitate loosening of the primary closure to permit further wound healing by second intention, with a resultant prolonged healing time, explained Dr. Girbig, of the Institute for Health Sciences Research in Dermatology and Nursing at University Medical Center Hamburg-Eppendorf (Germany).

She and her coinvestigators hypothesized that the disordered wound healing is a consequence of the underlying inflammatory disease that lies at the core of HS, and that quelling the inflammation with adalimumab for at least 6 months before performing surgery with primary closure while the anti-TNF therapy continues would reduce the incidence of wound healing disorders.

This was borne out in the group’s small observational pilot study. It included 10 patients with HS who underwent surgery only after at least 6 months on adalimumab. Six had surgery for axillary HS and four for inguinal disease. Only 2 of the 10 developed a wound healing disorder. Both had surgical reconstruction in the inguinal area. Neither case involved infection. Surgical management entailed opening part of the suture to allow simultaneous secondary wound closure.

This 20% incidence of disordered wound healing when primary closure was carried out while systemic inflammation was controlled via adalimumab is markedly lower than rates reported using primary closure without adalimumab. Dr. Girbig and her coinvestigators are now conducting a larger controlled study to confirm their findings.

She reported having no financial conflicts regarding her study.

bjancin@mdedge.com

Delaying surgical reconstruction of fistula structures until after patients with hidradenitis suppurativa (HS) have been on adalimumab for a minimum of 6 months transforms primary wound closure into a highly attractive option, a pilot study suggests.

“Our experience suggests that under the effects of treatment with adalimumab, wound healing disorders with primary wound closure occur less often. And primary wound closure offers advantages over secondary wound healing: shorter length of inpatient stay, lower morbidity, fewer functional problems, and better quality of life,” Gefion Girbig, MD, said at the annual congress of the European Academy of Dermatology and Venereology.

She noted that primary wound closure following surgery for HS is controversial. For example, current German guidelines recommend complete surgical excision of HS lesions, followed by secondary wound healing; the guidelines advise against primary wound closure. But those guidelines were issued back in 2012, years before adalimumab (Humira) achieved regulatory approval as the first and to date only medication indicated for treatment of HS.

Experts agree that while adalimumab has been a difference maker for many patients with HS, surgery is still often necessary. And many surgeons prefer secondary wound healing in HS. That’s because healing by first intention has historically often resulted in complications involving wound healing disorders and infection. These complications necessitate loosening of the primary closure to permit further wound healing by second intention, with a resultant prolonged healing time, explained Dr. Girbig, of the Institute for Health Sciences Research in Dermatology and Nursing at University Medical Center Hamburg-Eppendorf (Germany).

She and her coinvestigators hypothesized that the disordered wound healing is a consequence of the underlying inflammatory disease that lies at the core of HS, and that quelling the inflammation with adalimumab for at least 6 months before performing surgery with primary closure while the anti-TNF therapy continues would reduce the incidence of wound healing disorders.

This was borne out in the group’s small observational pilot study. It included 10 patients with HS who underwent surgery only after at least 6 months on adalimumab. Six had surgery for axillary HS and four for inguinal disease. Only 2 of the 10 developed a wound healing disorder. Both had surgical reconstruction in the inguinal area. Neither case involved infection. Surgical management entailed opening part of the suture to allow simultaneous secondary wound closure.

This 20% incidence of disordered wound healing when primary closure was carried out while systemic inflammation was controlled via adalimumab is markedly lower than rates reported using primary closure without adalimumab. Dr. Girbig and her coinvestigators are now conducting a larger controlled study to confirm their findings.

She reported having no financial conflicts regarding her study.

bjancin@mdedge.com

Topical hypochlorous acid is an underutilized tool in the management of atopic dermatitis (AD), Joseph F. Fowler, MD, said at MedscapeLive’s annual Las Vegas Dermatology Seminar, held virtually this year.

“I definitely like hypochlorous acid products to reduce microbial load and improve itching,” said Dr. Fowler, a dermatologist at the University of Louisville (Ky.). “It’s certainly a useful adjunct – not your primary treatment – in managing atopic dermatitis, especially when infected.”

Topical stabilized hypochlorous acid for use on the skin is commercially available over the counter in gel and liquid spray forms. It’s not bleach, which is sodium hypochlorite. In fact, for use on the skin, hypochlorous acid is better than bleach, since it doesn’t stain dark clothes, it’s nonirritating, and it doesn’t smell like bleach.

“We’re not entirely sure why it has an anti-itch effect, but that might partly be due to its inhibition of mast cell degranulation. It stops the mast cell from releasing its itch-o-genic properties into the skin. It also inhibits phospholipase A2, resulting in reduction of leukotrienes and prostaglandins, which may also account for the anti-itch effect,” Dr. Fowler said.

Hypochlorous acid has a powerful antimicrobial effect. It is highly effective at rapidly killing a broad range of bacteria, viruses, and fungi, including Staphylococcus aureus, a pathogen of particular relevance in AD. After the Environmental Protection Agency added hypochlorous acid to its list of disinfectants known to be effective against coronavirus, commercial interest in the use of hypochlorous acid in higher concentrations as a disinfectant in office buildings, hospitals, and for other large-scale applications has ballooned. The product, made via a process involving electrolyzation of water, is inexpensive. It’s also nontoxic: It’s not perceived by the immune system as foreign, since hypochlorous acid is produced during the human innate immune response.

Dr. Fowler reported serving as a consultant to and on the speakers bureau for SmartPractice, and receiving research funding from Asana, Edesa Biotech, J&J, and Novartis.

MedscapeLive and this news organization are owned by the same parent company.

bjancin@mdedge.com

Topical hypochlorous acid is an underutilized tool in the management of atopic dermatitis (AD), Joseph F. Fowler, MD, said at MedscapeLive’s annual Las Vegas Dermatology Seminar, held virtually this year.

“I definitely like hypochlorous acid products to reduce microbial load and improve itching,” said Dr. Fowler, a dermatologist at the University of Louisville (Ky.). “It’s certainly a useful adjunct – not your primary treatment – in managing atopic dermatitis, especially when infected.”

Topical stabilized hypochlorous acid for use on the skin is commercially available over the counter in gel and liquid spray forms. It’s not bleach, which is sodium hypochlorite. In fact, for use on the skin, hypochlorous acid is better than bleach, since it doesn’t stain dark clothes, it’s nonirritating, and it doesn’t smell like bleach.

“We’re not entirely sure why it has an anti-itch effect, but that might partly be due to its inhibition of mast cell degranulation. It stops the mast cell from releasing its itch-o-genic properties into the skin. It also inhibits phospholipase A2, resulting in reduction of leukotrienes and prostaglandins, which may also account for the anti-itch effect,” Dr. Fowler said.

Hypochlorous acid has a powerful antimicrobial effect. It is highly effective at rapidly killing a broad range of bacteria, viruses, and fungi, including Staphylococcus aureus, a pathogen of particular relevance in AD. After the Environmental Protection Agency added hypochlorous acid to its list of disinfectants known to be effective against coronavirus, commercial interest in the use of hypochlorous acid in higher concentrations as a disinfectant in office buildings, hospitals, and for other large-scale applications has ballooned. The product, made via a process involving electrolyzation of water, is inexpensive. It’s also nontoxic: It’s not perceived by the immune system as foreign, since hypochlorous acid is produced during the human innate immune response.

Dr. Fowler reported serving as a consultant to and on the speakers bureau for SmartPractice, and receiving research funding from Asana, Edesa Biotech, J&J, and Novartis.

MedscapeLive and this news organization are owned by the same parent company.

bjancin@mdedge.com

Topical hypochlorous acid is an underutilized tool in the management of atopic dermatitis (AD), Joseph F. Fowler, MD, said at MedscapeLive’s annual Las Vegas Dermatology Seminar, held virtually this year.

“I definitely like hypochlorous acid products to reduce microbial load and improve itching,” said Dr. Fowler, a dermatologist at the University of Louisville (Ky.). “It’s certainly a useful adjunct – not your primary treatment – in managing atopic dermatitis, especially when infected.”

Topical stabilized hypochlorous acid for use on the skin is commercially available over the counter in gel and liquid spray forms. It’s not bleach, which is sodium hypochlorite. In fact, for use on the skin, hypochlorous acid is better than bleach, since it doesn’t stain dark clothes, it’s nonirritating, and it doesn’t smell like bleach.

“We’re not entirely sure why it has an anti-itch effect, but that might partly be due to its inhibition of mast cell degranulation. It stops the mast cell from releasing its itch-o-genic properties into the skin. It also inhibits phospholipase A2, resulting in reduction of leukotrienes and prostaglandins, which may also account for the anti-itch effect,” Dr. Fowler said.

Hypochlorous acid has a powerful antimicrobial effect. It is highly effective at rapidly killing a broad range of bacteria, viruses, and fungi, including Staphylococcus aureus, a pathogen of particular relevance in AD. After the Environmental Protection Agency added hypochlorous acid to its list of disinfectants known to be effective against coronavirus, commercial interest in the use of hypochlorous acid in higher concentrations as a disinfectant in office buildings, hospitals, and for other large-scale applications has ballooned. The product, made via a process involving electrolyzation of water, is inexpensive. It’s also nontoxic: It’s not perceived by the immune system as foreign, since hypochlorous acid is produced during the human innate immune response.

Dr. Fowler reported serving as a consultant to and on the speakers bureau for SmartPractice, and receiving research funding from Asana, Edesa Biotech, J&J, and Novartis.

MedscapeLive and this news organization are owned by the same parent company.

bjancin@mdedge.com

A test that uses machine learning may improve the management of patients with pancreatic cysts, sparing some of them unnecessary surgery, a cohort study suggests.

The test, called CompCyst, integrates clinical, imaging, and biomarker data. It proved more accurate than the current standard of care for correctly determining whether patients should be discharged from follow-up, immediately operated on, or monitored.

Rachel Karchin, PhD, of the Johns Hopkins Whiting School of Engineering in Baltimore, reported these results at the AACR Virtual Special Conference: Artificial Intelligence, Diagnosis, and Imaging (Abstract IA-13).

“Preoperative diagnosis of pancreatic cysts and managing patients who present with a cyst are a clinical conundrum because pancreatic cancer is so deadly, while the decision to surgically resect a cyst is complicated by the danger of the surgery, which has high morbidity and mortality,” Dr. Karchin explained. “The challenge of the diagnostic test is to place patients into one of three groups: those who should be discharged, who should be operated on, and who should be monitored.”

High sensitivity is important for the operate and monitor groups to ensure identification of all patients needing these approaches, whereas higher specificity is important for the discharge group to avoid falsely classifying premalignant cysts, Dr. Karchin said.

She and her colleagues applied machine learning to this classification challenge, using data from 862 patients who had undergone resection of pancreatic cysts at 16 centers in the United States, Europe, and Asia. All patients had a known cyst histopathology, which served as the gold standard, and a known clinical management strategy (discharge, operate, or monitor).

The investigators used a multivariate organization of combinatorial alterations algorithm that integrates clinical features, imaging characteristics, cyst fluid genetics, and serum biomarkers to create classifiers. This algorithm can be trained to maximize sensitivity, maximize specificity, or balance these metrics, Dr. Karchin noted.

The resulting test, CompCyst, was trained using data from 436 of the patients and then validated in the remaining 426 patients.

In the validation cohort, for classifying patients who should be discharged from care, the test had a sensitivity of 46% and a specificity of 100%, according to results reported at the conference and published previously (Sci Transl Med. 2019 Jul 19. doi: 10.1126/scitranslmed.aav4772).

For immediately operating, CompCyst had a sensitivity of 91% and a specificity of 54%. And for monitoring the patient, the test had a sensitivity of 99% and a specificity of 30%.

When CompCyst was compared against the standard of care based on conventional clinical and imaging criteria alone, the former was more accurate. CompCyst correctly identified larger shares of patients who should have been discharged (60% vs. 19%) and who should have been monitored (49% vs. 34%), and the test identified a similar share of patients who should have immediately had an operation (91% vs. 89%).

“The takeaway from this is that standard of care is sending too many patients unnecessarily to surgery,” Dr. Karchin commented. “The CompCyst test, with application of the three classifiers sequentially – discharge, operate, or monitor – could reduce unnecessary surgery by 60% or more based on our calculations.”

“While our study was retrospective, it shows promising results in reducing unnecessary surgeries, compared to current standard of care,” she said, adding that a prospective study is planned next.

“In 10-12 weeks, this CompCyst diagnostic test is going to be available at Johns Hopkins for patients. I’m very excited about that,” Dr. Karchin concluded. “We hope that our study shows the potential of combining clinical, imaging, and genetic features with machine learning to improve clinical judgment about many diseases.”

Dr. Karchin disclosed no conflicts of interest. The study was supported by the Lustgarten Foundation for Pancreatic Cancer Research, the Virginia and D.K. Ludwig Fund for Cancer Research, the Sol Goldman Pancreatic Cancer Research Center, the Michael Rolfe Pancreatic Cancer Research Foundation, the Benjamin Baker Scholarship, and the National Institutes of Health.

Help your patients understand pancreatitis testing and treatment options, symptoms and complications by sharing AGA’s patient education from the GI Patient Center: www.gastro.org/pancreatitis.

A test that uses machine learning may improve the management of patients with pancreatic cysts, sparing some of them unnecessary surgery, a cohort study suggests.

The test, called CompCyst, integrates clinical, imaging, and biomarker data. It proved more accurate than the current standard of care for correctly determining whether patients should be discharged from follow-up, immediately operated on, or monitored.

Rachel Karchin, PhD, of the Johns Hopkins Whiting School of Engineering in Baltimore, reported these results at the AACR Virtual Special Conference: Artificial Intelligence, Diagnosis, and Imaging (Abstract IA-13).

“Preoperative diagnosis of pancreatic cysts and managing patients who present with a cyst are a clinical conundrum because pancreatic cancer is so deadly, while the decision to surgically resect a cyst is complicated by the danger of the surgery, which has high morbidity and mortality,” Dr. Karchin explained. “The challenge of the diagnostic test is to place patients into one of three groups: those who should be discharged, who should be operated on, and who should be monitored.”

High sensitivity is important for the operate and monitor groups to ensure identification of all patients needing these approaches, whereas higher specificity is important for the discharge group to avoid falsely classifying premalignant cysts, Dr. Karchin said.

She and her colleagues applied machine learning to this classification challenge, using data from 862 patients who had undergone resection of pancreatic cysts at 16 centers in the United States, Europe, and Asia. All patients had a known cyst histopathology, which served as the gold standard, and a known clinical management strategy (discharge, operate, or monitor).

The investigators used a multivariate organization of combinatorial alterations algorithm that integrates clinical features, imaging characteristics, cyst fluid genetics, and serum biomarkers to create classifiers. This algorithm can be trained to maximize sensitivity, maximize specificity, or balance these metrics, Dr. Karchin noted.

The resulting test, CompCyst, was trained using data from 436 of the patients and then validated in the remaining 426 patients.

In the validation cohort, for classifying patients who should be discharged from care, the test had a sensitivity of 46% and a specificity of 100%, according to results reported at the conference and published previously (Sci Transl Med. 2019 Jul 19. doi: 10.1126/scitranslmed.aav4772).

For immediately operating, CompCyst had a sensitivity of 91% and a specificity of 54%. And for monitoring the patient, the test had a sensitivity of 99% and a specificity of 30%.

When CompCyst was compared against the standard of care based on conventional clinical and imaging criteria alone, the former was more accurate. CompCyst correctly identified larger shares of patients who should have been discharged (60% vs. 19%) and who should have been monitored (49% vs. 34%), and the test identified a similar share of patients who should have immediately had an operation (91% vs. 89%).

“The takeaway from this is that standard of care is sending too many patients unnecessarily to surgery,” Dr. Karchin commented. “The CompCyst test, with application of the three classifiers sequentially – discharge, operate, or monitor – could reduce unnecessary surgery by 60% or more based on our calculations.”

“While our study was retrospective, it shows promising results in reducing unnecessary surgeries, compared to current standard of care,” she said, adding that a prospective study is planned next.

“In 10-12 weeks, this CompCyst diagnostic test is going to be available at Johns Hopkins for patients. I’m very excited about that,” Dr. Karchin concluded. “We hope that our study shows the potential of combining clinical, imaging, and genetic features with machine learning to improve clinical judgment about many diseases.”

Dr. Karchin disclosed no conflicts of interest. The study was supported by the Lustgarten Foundation for Pancreatic Cancer Research, the Virginia and D.K. Ludwig Fund for Cancer Research, the Sol Goldman Pancreatic Cancer Research Center, the Michael Rolfe Pancreatic Cancer Research Foundation, the Benjamin Baker Scholarship, and the National Institutes of Health.

Help your patients understand pancreatitis testing and treatment options, symptoms and complications by sharing AGA’s patient education from the GI Patient Center: www.gastro.org/pancreatitis.

A test that uses machine learning may improve the management of patients with pancreatic cysts, sparing some of them unnecessary surgery, a cohort study suggests.

The test, called CompCyst, integrates clinical, imaging, and biomarker data. It proved more accurate than the current standard of care for correctly determining whether patients should be discharged from follow-up, immediately operated on, or monitored.

Rachel Karchin, PhD, of the Johns Hopkins Whiting School of Engineering in Baltimore, reported these results at the AACR Virtual Special Conference: Artificial Intelligence, Diagnosis, and Imaging (Abstract IA-13).

“Preoperative diagnosis of pancreatic cysts and managing patients who present with a cyst are a clinical conundrum because pancreatic cancer is so deadly, while the decision to surgically resect a cyst is complicated by the danger of the surgery, which has high morbidity and mortality,” Dr. Karchin explained. “The challenge of the diagnostic test is to place patients into one of three groups: those who should be discharged, who should be operated on, and who should be monitored.”

High sensitivity is important for the operate and monitor groups to ensure identification of all patients needing these approaches, whereas higher specificity is important for the discharge group to avoid falsely classifying premalignant cysts, Dr. Karchin said.

She and her colleagues applied machine learning to this classification challenge, using data from 862 patients who had undergone resection of pancreatic cysts at 16 centers in the United States, Europe, and Asia. All patients had a known cyst histopathology, which served as the gold standard, and a known clinical management strategy (discharge, operate, or monitor).

The investigators used a multivariate organization of combinatorial alterations algorithm that integrates clinical features, imaging characteristics, cyst fluid genetics, and serum biomarkers to create classifiers. This algorithm can be trained to maximize sensitivity, maximize specificity, or balance these metrics, Dr. Karchin noted.

The resulting test, CompCyst, was trained using data from 436 of the patients and then validated in the remaining 426 patients.

In the validation cohort, for classifying patients who should be discharged from care, the test had a sensitivity of 46% and a specificity of 100%, according to results reported at the conference and published previously (Sci Transl Med. 2019 Jul 19. doi: 10.1126/scitranslmed.aav4772).

For immediately operating, CompCyst had a sensitivity of 91% and a specificity of 54%. And for monitoring the patient, the test had a sensitivity of 99% and a specificity of 30%.

When CompCyst was compared against the standard of care based on conventional clinical and imaging criteria alone, the former was more accurate. CompCyst correctly identified larger shares of patients who should have been discharged (60% vs. 19%) and who should have been monitored (49% vs. 34%), and the test identified a similar share of patients who should have immediately had an operation (91% vs. 89%).

“The takeaway from this is that standard of care is sending too many patients unnecessarily to surgery,” Dr. Karchin commented. “The CompCyst test, with application of the three classifiers sequentially – discharge, operate, or monitor – could reduce unnecessary surgery by 60% or more based on our calculations.”

“While our study was retrospective, it shows promising results in reducing unnecessary surgeries, compared to current standard of care,” she said, adding that a prospective study is planned next.

“In 10-12 weeks, this CompCyst diagnostic test is going to be available at Johns Hopkins for patients. I’m very excited about that,” Dr. Karchin concluded. “We hope that our study shows the potential of combining clinical, imaging, and genetic features with machine learning to improve clinical judgment about many diseases.”

Dr. Karchin disclosed no conflicts of interest. The study was supported by the Lustgarten Foundation for Pancreatic Cancer Research, the Virginia and D.K. Ludwig Fund for Cancer Research, the Sol Goldman Pancreatic Cancer Research Center, the Michael Rolfe Pancreatic Cancer Research Foundation, the Benjamin Baker Scholarship, and the National Institutes of Health.

Help your patients understand pancreatitis testing and treatment options, symptoms and complications by sharing AGA’s patient education from the GI Patient Center: www.gastro.org/pancreatitis.

Long-term follow-up data show a continued benefit for patients with advanced hepatocellular carcinoma (HCC) treated with nivolumab and ipilimumab after disease progression on sorafenib, according to investigators from the Checkmate 040 trial.

At a minimum follow-up of 44 months, the 3-year overall survival rate ranged from 30% to 42% in patients who received three different nivolumab-ipilimumab regimens, reported Anthony B. El-Khoueiry, MD, of the University of Southern California in Los Angeles.

“Durable responses were achieved across treatment arms, with the duration of response approaching 4 years in some cases,” Dr. El-Khoueiry said at the 2021 Gastrointestinal Cancers Symposium (Abstract 269).

The Checkmate 040 trial was designed to compare second- or later-line therapy with the two checkpoint inhibitors at two different dose schedules, followed by maintenance therapy, plus a third continuous therapy arm.

The trial included 148 patients with advanced HCC who experienced disease progression on sorafenib or could not tolerate the drug. They were randomly assigned on a 1:1:1 basis to receive:

• Nivolumab at 1 mg/kg plus ipilimumab at 3 mg/kg every 3 weeks for 4 cycles, followed by nivolumab maintenance at 240 mg every 2 weeks (nivo 1 + ipi 3).
• Nivolumab at 3 mg/kg plus ipilimumab at 1 mg/kg every 3 weeks for 4 cycles, followed by nivolumab maintenance (nivo 3 + ipi 1).
• Nivolumab at 3 mg/kg every 2 weeks plus ipilimumab at 1 mg/kg every 6 weeks until disease progression or unacceptable toxicity (nivo 3 + ipi 1 Q6).

Based on earlier results of this trial, the nivo 1 + ipi 3 dose with nivolumab maintenance was approved in the United States for patients with advanced HCC previously treated with sorafenib.
 

Four years on

“Response outcomes at 44 months of follow-up were consistent with the primary analysis,” Dr. El-Khoueiry said.

The overall response rate at the most recent follow-up was 32% for nivo 1 + ipi 3, and 31% in each of the other arms.

The disease control rate – a combination of complete and partial responses and stable disease – was 54% in the nivo 1 + ipi 3 arm, 43% in the nivo 3 + ipi 1 arm, and 49% in the nivo 3 + ipi 1 Q6 arm.

The 36-month overall survival rates were 42%, 26%, and 30%, respectively. Kaplan-Meier curves for overall survival for both the primary analysis and the long-term follow-up displayed a survival advantage for nivo 1 + ipi 3 compared with the other two arms.
 

Safety

Treatment-related adverse events occurred more frequently in the nivo 1 + ipi 3 arm, which investigators attribute to the higher dose of ipilimumab. The most common grade 3 or 4 events in this arm were elevated liver enzymes and hyponatremia.

Immune-related adverse events also occurred more frequently in the nivo 1 + ipi 3 arm.

“Most immune-mediated adverse events were reversible and resolved when treated using an established algorithm, with steroids being the most common immune-modulating medication used. There were no additional discontinuations due to immune-mediated adverse events during the longer follow-up,” Dr. El-Khoueiry said.
 

Best combination?

“It’s certainly good data, and we’re happy about the response rate of about 30%, and that was confirmed at [the Gastrointestinal Cancers Symposium] with further follow-up of these patients,” said Lipika Goyal, MD, of Mass General Cancer Center in Boston.

Whether the nivo/ipi combination will turn out to be the optimum choice for patients with advanced HCC is still unknown; however, many different combinations of checkpoint inhibitors with or without tyrosine kinase inhibitors are currently being explored, and have not been compared in head-to-head trials, Dr. Goyal said in an interview. Dr. Goyal was not involved in the Checkmate 040 study.

Checkmate 040 was supported by Bristol Myers Squibb. Dr. El-Khoueiry disclosed honoraria from and consulting/advising for the company and others. Dr. Goyal reported no relevant disclosures.

The Gastrointestinal Cancers Symposium is sponsored by the American Gastroenterological Association, the American Society for Clinical Oncology, the American Society for Radiation Oncology, and the Society of Surgical Oncology.

Long-term follow-up data show a continued benefit for patients with advanced hepatocellular carcinoma (HCC) treated with nivolumab and ipilimumab after disease progression on sorafenib, according to investigators from the Checkmate 040 trial.

At a minimum follow-up of 44 months, the 3-year overall survival rate ranged from 30% to 42% in patients who received three different nivolumab-ipilimumab regimens, reported Anthony B. El-Khoueiry, MD, of the University of Southern California in Los Angeles.

“Durable responses were achieved across treatment arms, with the duration of response approaching 4 years in some cases,” Dr. El-Khoueiry said at the 2021 Gastrointestinal Cancers Symposium (Abstract 269).

The Checkmate 040 trial was designed to compare second- or later-line therapy with the two checkpoint inhibitors at two different dose schedules, followed by maintenance therapy, plus a third continuous therapy arm.

The trial included 148 patients with advanced HCC who experienced disease progression on sorafenib or could not tolerate the drug. They were randomly assigned on a 1:1:1 basis to receive:

• Nivolumab at 1 mg/kg plus ipilimumab at 3 mg/kg every 3 weeks for 4 cycles, followed by nivolumab maintenance at 240 mg every 2 weeks (nivo 1 + ipi 3).
• Nivolumab at 3 mg/kg plus ipilimumab at 1 mg/kg every 3 weeks for 4 cycles, followed by nivolumab maintenance (nivo 3 + ipi 1).
• Nivolumab at 3 mg/kg every 2 weeks plus ipilimumab at 1 mg/kg every 6 weeks until disease progression or unacceptable toxicity (nivo 3 + ipi 1 Q6).

Based on earlier results of this trial, the nivo 1 + ipi 3 dose with nivolumab maintenance was approved in the United States for patients with advanced HCC previously treated with sorafenib.
 

Four years on

“Response outcomes at 44 months of follow-up were consistent with the primary analysis,” Dr. El-Khoueiry said.

The overall response rate at the most recent follow-up was 32% for nivo 1 + ipi 3, and 31% in each of the other arms.

The disease control rate – a combination of complete and partial responses and stable disease – was 54% in the nivo 1 + ipi 3 arm, 43% in the nivo 3 + ipi 1 arm, and 49% in the nivo 3 + ipi 1 Q6 arm.

The 36-month overall survival rates were 42%, 26%, and 30%, respectively. Kaplan-Meier curves for overall survival for both the primary analysis and the long-term follow-up displayed a survival advantage for nivo 1 + ipi 3 compared with the other two arms.
 

Safety

Treatment-related adverse events occurred more frequently in the nivo 1 + ipi 3 arm, which investigators attribute to the higher dose of ipilimumab. The most common grade 3 or 4 events in this arm were elevated liver enzymes and hyponatremia.

Immune-related adverse events also occurred more frequently in the nivo 1 + ipi 3 arm.

“Most immune-mediated adverse events were reversible and resolved when treated using an established algorithm, with steroids being the most common immune-modulating medication used. There were no additional discontinuations due to immune-mediated adverse events during the longer follow-up,” Dr. El-Khoueiry said.
 

Best combination?

“It’s certainly good data, and we’re happy about the response rate of about 30%, and that was confirmed at [the Gastrointestinal Cancers Symposium] with further follow-up of these patients,” said Lipika Goyal, MD, of Mass General Cancer Center in Boston.

Whether the nivo/ipi combination will turn out to be the optimum choice for patients with advanced HCC is still unknown; however, many different combinations of checkpoint inhibitors with or without tyrosine kinase inhibitors are currently being explored, and have not been compared in head-to-head trials, Dr. Goyal said in an interview. Dr. Goyal was not involved in the Checkmate 040 study.

Checkmate 040 was supported by Bristol Myers Squibb. Dr. El-Khoueiry disclosed honoraria from and consulting/advising for the company and others. Dr. Goyal reported no relevant disclosures.

The Gastrointestinal Cancers Symposium is sponsored by the American Gastroenterological Association, the American Society for Clinical Oncology, the American Society for Radiation Oncology, and the Society of Surgical Oncology.

Long-term follow-up data show a continued benefit for patients with advanced hepatocellular carcinoma (HCC) treated with nivolumab and ipilimumab after disease progression on sorafenib, according to investigators from the Checkmate 040 trial.

At a minimum follow-up of 44 months, the 3-year overall survival rate ranged from 30% to 42% in patients who received three different nivolumab-ipilimumab regimens, reported Anthony B. El-Khoueiry, MD, of the University of Southern California in Los Angeles.

“Durable responses were achieved across treatment arms, with the duration of response approaching 4 years in some cases,” Dr. El-Khoueiry said at the 2021 Gastrointestinal Cancers Symposium (Abstract 269).

The Checkmate 040 trial was designed to compare second- or later-line therapy with the two checkpoint inhibitors at two different dose schedules, followed by maintenance therapy, plus a third continuous therapy arm.

The trial included 148 patients with advanced HCC who experienced disease progression on sorafenib or could not tolerate the drug. They were randomly assigned on a 1:1:1 basis to receive:

• Nivolumab at 1 mg/kg plus ipilimumab at 3 mg/kg every 3 weeks for 4 cycles, followed by nivolumab maintenance at 240 mg every 2 weeks (nivo 1 + ipi 3).
• Nivolumab at 3 mg/kg plus ipilimumab at 1 mg/kg every 3 weeks for 4 cycles, followed by nivolumab maintenance (nivo 3 + ipi 1).
• Nivolumab at 3 mg/kg every 2 weeks plus ipilimumab at 1 mg/kg every 6 weeks until disease progression or unacceptable toxicity (nivo 3 + ipi 1 Q6).

Based on earlier results of this trial, the nivo 1 + ipi 3 dose with nivolumab maintenance was approved in the United States for patients with advanced HCC previously treated with sorafenib.
 

Four years on

“Response outcomes at 44 months of follow-up were consistent with the primary analysis,” Dr. El-Khoueiry said.

The overall response rate at the most recent follow-up was 32% for nivo 1 + ipi 3, and 31% in each of the other arms.

The disease control rate – a combination of complete and partial responses and stable disease – was 54% in the nivo 1 + ipi 3 arm, 43% in the nivo 3 + ipi 1 arm, and 49% in the nivo 3 + ipi 1 Q6 arm.

The 36-month overall survival rates were 42%, 26%, and 30%, respectively. Kaplan-Meier curves for overall survival for both the primary analysis and the long-term follow-up displayed a survival advantage for nivo 1 + ipi 3 compared with the other two arms.
 

Safety

Treatment-related adverse events occurred more frequently in the nivo 1 + ipi 3 arm, which investigators attribute to the higher dose of ipilimumab. The most common grade 3 or 4 events in this arm were elevated liver enzymes and hyponatremia.

Immune-related adverse events also occurred more frequently in the nivo 1 + ipi 3 arm.

“Most immune-mediated adverse events were reversible and resolved when treated using an established algorithm, with steroids being the most common immune-modulating medication used. There were no additional discontinuations due to immune-mediated adverse events during the longer follow-up,” Dr. El-Khoueiry said.
 

Best combination?

“It’s certainly good data, and we’re happy about the response rate of about 30%, and that was confirmed at [the Gastrointestinal Cancers Symposium] with further follow-up of these patients,” said Lipika Goyal, MD, of Mass General Cancer Center in Boston.

Whether the nivo/ipi combination will turn out to be the optimum choice for patients with advanced HCC is still unknown; however, many different combinations of checkpoint inhibitors with or without tyrosine kinase inhibitors are currently being explored, and have not been compared in head-to-head trials, Dr. Goyal said in an interview. Dr. Goyal was not involved in the Checkmate 040 study.

Checkmate 040 was supported by Bristol Myers Squibb. Dr. El-Khoueiry disclosed honoraria from and consulting/advising for the company and others. Dr. Goyal reported no relevant disclosures.

The Gastrointestinal Cancers Symposium is sponsored by the American Gastroenterological Association, the American Society for Clinical Oncology, the American Society for Radiation Oncology, and the Society of Surgical Oncology.