Exposure to antibiotics in mid- to late pregnancy was associated with childhood asthma in vaginally born children, in a Danish birth cohort study.

The reason behind the correlation is unclear. Maternal infections, rather than antibiotics, “could explain the observed association,” said study author Cecilie Skaarup Uldbjerg, a researcher in the department of public health at Aarhus University in Denmark.

Still, the “results are in keeping with the hypothesis that effects of antibiotics impact the maternally derived microbiome in vaginally born children and that this may increase the odds of childhood asthma,” Ms. Uldbjerg and coauthors wrote in their study, which was published online Feb. 9 in Archives of Disease in Childhood . “However, this observational study did not address underlying mechanisms, and this interpretation, while plausible, remains speculative.”
 

Antibiotic use in pregnancy likely to continue

Patrick Duff, MD, who was not involved in the research, does not expect the findings will alter clinical practice.

The association was relatively weak, and the study does not account for factors such as antibiotic exposure during early childhood or tobacco smoke in the house, said Dr. Duff, professor of maternal-fetal medicine at University of Florida, Gainesville.

“Although I agree that we should not use antibiotics indiscriminately during pregnancy, we definitely need to treat certain infections,” Dr. Duff said. “Thus we cannot avoid some degree of antibiotic exposure.”

Although prior research has indicated that antibiotic use in pregnancy may increase the risk of asthma in children, results have been inconsistent.

To study whether antibiotic exposure during pregnancy is associated with childhood asthma and whether the timing of antibiotic exposure or mode of delivery influence the relationship, the investigators analyzed data from more than 32,000 children in the Danish National Birth Cohort, which was established in 1996.
 

Children of mothers who took and did not take antibiotics compared

In all, 17% of the children were born to mothers who used antibiotics during pregnancy. Compared with mothers who did not take antibiotics, those who did reported more maternal asthma, smoking during pregnancy, and having overweight or obesity. In addition, they were less likely to have been in their first pregnancy.

During follow-up at age 11 years, 4,238 children (13%) had asthma, including 12.7% of those whose mothers had not been exposed to antibiotics, and 14.6% of those whose mothers had used antibiotics during pregnancy.

In adjusted analyses, children born to mothers who received antibiotics were more likely to have asthma (OR, 1.14).

Antibiotic exposure in the second to third trimester, but not in the first trimester, was associated with asthma. The association was observed in vaginally born children, but not in children born by cesarean section.

The study is limited by its reliance on maternal reporting for data about antibiotics and asthma diagnoses, the authors noted. Mothers completed telephone interviews twice during pregnancy and once at 6 months postpartum. They completed online questionnaires to provide follow-up information at 11 years.
 

Mode of delivery may matter

The researchers said their analysis indicates that mode of delivery may modify the association between antibiotic exposure during pregnancy and childhood asthma.

Fourteen percent of the children in the study were delivered by cesarean section. Further research may clarify the relationship between antibiotics in pregnancy, mode of delivery, and asthma risk, another doctor who was not involved the study added.

“I do not think that the evidence indicates that mode of delivery clearly has an impact,” said Santina J. G. Wheat, MD, MPH, associate professor of family and community medicine at Northwestern University in Chicago, “as the number of cesarean deliveries was not large enough to fully support such a statement.

“It will be interesting to see if an association holds in future studies with increased cesarean deliveries,” Dr. Wheat said.

How and why antibiotics were used may be other important factors to investigate, Dr. Duff suggested.

“The authors did not provide any specific information about which antibiotics were used by the mothers, duration of use, and indication for use. Those are very important confounders,” Dr. Duff said. “Perhaps the key exposure is to a particular maternal infection rather than to the antibiotic per se.”

The Danish National Birth Cohort was established with a grant from the Danish National Research Foundation and support from regional committees and other organizations. Its biobank has been supported by the Novo Nordisk Foundation and the Lundbeck Foundation, and follow-up of mothers and children has been supported by the Danish Medical Research Council, the Lundbeck Foundation, Innovation Fund Denmark, the Nordea Foundation, Aarhus Ideas, a University of Copenhagen strategic grant, and the Danish Council for Independent Research. The study was partially funded by the Health Research Fund of Central Denmark Region, which supported one of the authors. Other authors were supported by the DHB Foundation and the Australian National Health and Medical Research Council. One author is affiliated with Murdoch Children’s Research Institute in Australia, where the Victorian Government’s Operational Infrastructure Support Program supports research.

The authors had no competing interests. Dr. Wheat serves on the editorial advisory board of Family Practice News. Dr. Duff had no relevant financial disclosures.

[email protected]

Exposure to antibiotics in mid- to late pregnancy was associated with childhood asthma in vaginally born children, in a Danish birth cohort study.

The reason behind the correlation is unclear. Maternal infections, rather than antibiotics, “could explain the observed association,” said study author Cecilie Skaarup Uldbjerg, a researcher in the department of public health at Aarhus University in Denmark.

Still, the “results are in keeping with the hypothesis that effects of antibiotics impact the maternally derived microbiome in vaginally born children and that this may increase the odds of childhood asthma,” Ms. Uldbjerg and coauthors wrote in their study, which was published online Feb. 9 in Archives of Disease in Childhood . “However, this observational study did not address underlying mechanisms, and this interpretation, while plausible, remains speculative.”
 

Antibiotic use in pregnancy likely to continue

Patrick Duff, MD, who was not involved in the research, does not expect the findings will alter clinical practice.

The association was relatively weak, and the study does not account for factors such as antibiotic exposure during early childhood or tobacco smoke in the house, said Dr. Duff, professor of maternal-fetal medicine at University of Florida, Gainesville.

“Although I agree that we should not use antibiotics indiscriminately during pregnancy, we definitely need to treat certain infections,” Dr. Duff said. “Thus we cannot avoid some degree of antibiotic exposure.”

Although prior research has indicated that antibiotic use in pregnancy may increase the risk of asthma in children, results have been inconsistent.

To study whether antibiotic exposure during pregnancy is associated with childhood asthma and whether the timing of antibiotic exposure or mode of delivery influence the relationship, the investigators analyzed data from more than 32,000 children in the Danish National Birth Cohort, which was established in 1996.
 

Children of mothers who took and did not take antibiotics compared

In all, 17% of the children were born to mothers who used antibiotics during pregnancy. Compared with mothers who did not take antibiotics, those who did reported more maternal asthma, smoking during pregnancy, and having overweight or obesity. In addition, they were less likely to have been in their first pregnancy.

During follow-up at age 11 years, 4,238 children (13%) had asthma, including 12.7% of those whose mothers had not been exposed to antibiotics, and 14.6% of those whose mothers had used antibiotics during pregnancy.

In adjusted analyses, children born to mothers who received antibiotics were more likely to have asthma (OR, 1.14).

Antibiotic exposure in the second to third trimester, but not in the first trimester, was associated with asthma. The association was observed in vaginally born children, but not in children born by cesarean section.

The study is limited by its reliance on maternal reporting for data about antibiotics and asthma diagnoses, the authors noted. Mothers completed telephone interviews twice during pregnancy and once at 6 months postpartum. They completed online questionnaires to provide follow-up information at 11 years.
 

Mode of delivery may matter

The researchers said their analysis indicates that mode of delivery may modify the association between antibiotic exposure during pregnancy and childhood asthma.

Fourteen percent of the children in the study were delivered by cesarean section. Further research may clarify the relationship between antibiotics in pregnancy, mode of delivery, and asthma risk, another doctor who was not involved the study added.

“I do not think that the evidence indicates that mode of delivery clearly has an impact,” said Santina J. G. Wheat, MD, MPH, associate professor of family and community medicine at Northwestern University in Chicago, “as the number of cesarean deliveries was not large enough to fully support such a statement.

“It will be interesting to see if an association holds in future studies with increased cesarean deliveries,” Dr. Wheat said.

How and why antibiotics were used may be other important factors to investigate, Dr. Duff suggested.

“The authors did not provide any specific information about which antibiotics were used by the mothers, duration of use, and indication for use. Those are very important confounders,” Dr. Duff said. “Perhaps the key exposure is to a particular maternal infection rather than to the antibiotic per se.”

The Danish National Birth Cohort was established with a grant from the Danish National Research Foundation and support from regional committees and other organizations. Its biobank has been supported by the Novo Nordisk Foundation and the Lundbeck Foundation, and follow-up of mothers and children has been supported by the Danish Medical Research Council, the Lundbeck Foundation, Innovation Fund Denmark, the Nordea Foundation, Aarhus Ideas, a University of Copenhagen strategic grant, and the Danish Council for Independent Research. The study was partially funded by the Health Research Fund of Central Denmark Region, which supported one of the authors. Other authors were supported by the DHB Foundation and the Australian National Health and Medical Research Council. One author is affiliated with Murdoch Children’s Research Institute in Australia, where the Victorian Government’s Operational Infrastructure Support Program supports research.

The authors had no competing interests. Dr. Wheat serves on the editorial advisory board of Family Practice News. Dr. Duff had no relevant financial disclosures.

[email protected]

Exposure to antibiotics in mid- to late pregnancy was associated with childhood asthma in vaginally born children, in a Danish birth cohort study.

The reason behind the correlation is unclear. Maternal infections, rather than antibiotics, “could explain the observed association,” said study author Cecilie Skaarup Uldbjerg, a researcher in the department of public health at Aarhus University in Denmark.

Still, the “results are in keeping with the hypothesis that effects of antibiotics impact the maternally derived microbiome in vaginally born children and that this may increase the odds of childhood asthma,” Ms. Uldbjerg and coauthors wrote in their study, which was published online Feb. 9 in Archives of Disease in Childhood . “However, this observational study did not address underlying mechanisms, and this interpretation, while plausible, remains speculative.”
 

Antibiotic use in pregnancy likely to continue

Patrick Duff, MD, who was not involved in the research, does not expect the findings will alter clinical practice.

The association was relatively weak, and the study does not account for factors such as antibiotic exposure during early childhood or tobacco smoke in the house, said Dr. Duff, professor of maternal-fetal medicine at University of Florida, Gainesville.

“Although I agree that we should not use antibiotics indiscriminately during pregnancy, we definitely need to treat certain infections,” Dr. Duff said. “Thus we cannot avoid some degree of antibiotic exposure.”

Although prior research has indicated that antibiotic use in pregnancy may increase the risk of asthma in children, results have been inconsistent.

To study whether antibiotic exposure during pregnancy is associated with childhood asthma and whether the timing of antibiotic exposure or mode of delivery influence the relationship, the investigators analyzed data from more than 32,000 children in the Danish National Birth Cohort, which was established in 1996.
 

Children of mothers who took and did not take antibiotics compared

In all, 17% of the children were born to mothers who used antibiotics during pregnancy. Compared with mothers who did not take antibiotics, those who did reported more maternal asthma, smoking during pregnancy, and having overweight or obesity. In addition, they were less likely to have been in their first pregnancy.

During follow-up at age 11 years, 4,238 children (13%) had asthma, including 12.7% of those whose mothers had not been exposed to antibiotics, and 14.6% of those whose mothers had used antibiotics during pregnancy.

In adjusted analyses, children born to mothers who received antibiotics were more likely to have asthma (OR, 1.14).

Antibiotic exposure in the second to third trimester, but not in the first trimester, was associated with asthma. The association was observed in vaginally born children, but not in children born by cesarean section.

The study is limited by its reliance on maternal reporting for data about antibiotics and asthma diagnoses, the authors noted. Mothers completed telephone interviews twice during pregnancy and once at 6 months postpartum. They completed online questionnaires to provide follow-up information at 11 years.
 

Mode of delivery may matter

The researchers said their analysis indicates that mode of delivery may modify the association between antibiotic exposure during pregnancy and childhood asthma.

Fourteen percent of the children in the study were delivered by cesarean section. Further research may clarify the relationship between antibiotics in pregnancy, mode of delivery, and asthma risk, another doctor who was not involved the study added.

“I do not think that the evidence indicates that mode of delivery clearly has an impact,” said Santina J. G. Wheat, MD, MPH, associate professor of family and community medicine at Northwestern University in Chicago, “as the number of cesarean deliveries was not large enough to fully support such a statement.

“It will be interesting to see if an association holds in future studies with increased cesarean deliveries,” Dr. Wheat said.

How and why antibiotics were used may be other important factors to investigate, Dr. Duff suggested.

“The authors did not provide any specific information about which antibiotics were used by the mothers, duration of use, and indication for use. Those are very important confounders,” Dr. Duff said. “Perhaps the key exposure is to a particular maternal infection rather than to the antibiotic per se.”

The Danish National Birth Cohort was established with a grant from the Danish National Research Foundation and support from regional committees and other organizations. Its biobank has been supported by the Novo Nordisk Foundation and the Lundbeck Foundation, and follow-up of mothers and children has been supported by the Danish Medical Research Council, the Lundbeck Foundation, Innovation Fund Denmark, the Nordea Foundation, Aarhus Ideas, a University of Copenhagen strategic grant, and the Danish Council for Independent Research. The study was partially funded by the Health Research Fund of Central Denmark Region, which supported one of the authors. Other authors were supported by the DHB Foundation and the Australian National Health and Medical Research Council. One author is affiliated with Murdoch Children’s Research Institute in Australia, where the Victorian Government’s Operational Infrastructure Support Program supports research.

The authors had no competing interests. Dr. Wheat serves on the editorial advisory board of Family Practice News. Dr. Duff had no relevant financial disclosures.

[email protected]

Gestational age and weight at discharge for infants aged 24-29 weeks increased steadily between 2005 and 2018, reported Erika M. Edwards, PhD, MPH, of the Vermont Oxford Network, Burlington, and associates.

Metin Kiyak/Thinkstock

Although they discussed several possible influencing factors, the authors were unable to explain the associated benefits, costs, and harms associated with increased age and weight at discharge, which remain undetermined. Infants are separated a week longer than they were at the beginning of the study period, the prolonged effects of which cannot be underestimated, Dr. Edwards and colleagues observed in a large cohort study in Pediatrics.

A total of 314,811 infants 24-29 weeks’ gestational age who were admitted to 824 neonatal ICUs (NICUs) throughout the United States survived to initial discharge. The median postmenstrual age at hospital discharge was 38.3 weeks. Over the 14-year period from 2005 to 2018, unadjusted postmenstrual age at discharge increased a median 9 days, compared with a median adjusted age of 8 days.

Of the 273,109 infants initially discharged from the hospital to home, median weight at discharge was 2,600 g. Over the 14 years from 2005 to 2018, median unadjusted discharge weight increased 360 g, compared with median adjusted weight, which was estimated to have increased 316 g.

Median unadjusted z scores for weight increased 0.22 standard units over the 14-year period, compared with median adjusted z scores for weight at discharge, which increased an estimated 0.19 standard units.

The proportion of infants who were consuming human milk at discharge increased over the study period from 40% in 2005 to 48% in 2018. The use of cardiorespiratory monitors and oxygen decreased from 49% to 26%, and 27% to 22% respectively. The number of infants who were never transferred to specialized care before discharge to home also improved, from 71% to 76%.
 

Despite the unknowns, good news for managing pediatricians?

In a separate interview, study author Dr. Edwards noted that “infants born very preterm, who are discharged home from the NICU today, are larger and more physiologically mature than they were in 2005. Pediatricians will likely find this news to be positive as it may be easier to manage care for a more physiologically mature [infant],” and it may reduce risk of readmission.

“Infants stayed, on average, 8 days longer in 2018 than they did in 2005. That is 8 days when they were not at home with their families. Despite efforts by NICU teams to increase family-centered care, the NICU is not the same as being at home. ... That extra time in the NICU cost [some families] an estimated $28,000. ... As health care costs continue to rise, we need to understand the true cost [behind] this increase,” added Dr. Edwards, noting that more research is needed to understand what may be driving the increase in NICU length of stay and the possible implications. More research to investigate whether babies did better after discharge also is needed.

Going forward, Dr. Edwards indicated that she and her colleagues are exploring ways to measure apnea of prematurity (AOP) and use of continuous pulse oximetry (CPO) as the subject of future studies. In our study, we showed that the number of infants discharged home on a cardiorespiratory monitor decreased, but we do not know if that is explained by differences in management of AOP and CPO. “Understanding the influence of AOP and CPO management on discharge age would be an important contribution [to future research].”
 

AOP may drive increase in postmenstrual age

In an accompanying editorial, Cody Arnold, MD, and Alexis S. Davis, MD, said: “We have focused on apnea of prematurity and discharge countdowns in this commentary because we believe that changes in related practices are likely the most important drivers of the increases in postmenstrual age” reported by the authors in this study. “Other factors, such as increasing availability of NICU beds or decreasing availability of home support services, may have contributed to longer length of stay. But these questions should be answered by research, not by speculation,” said Dr. Arnold, neonatologist, University of Texas Health Sciences Center, Houston, and Dr. Davis, clinical associate professor, Stanford (Calif.) University.

“Prospective research comparing alternative countdown strategies on the basis of readmission rates and other outpatient outcomes is overdue.” Additional research is needed operationally to clearly outline parameters for countdown events, countdown duration, indications for CPO, outpatient caffeine use, and parental shared decision-making.”

The study was funded by the Vermont Oxford Network. Dr. Edwards received a grant from the Vermont Oxford Network; several others also had ties to the Network. Dr. Arnold and Dr. Davis had no conflicts of interest and reported no disclosures.

Gestational age and weight at discharge for infants aged 24-29 weeks increased steadily between 2005 and 2018, reported Erika M. Edwards, PhD, MPH, of the Vermont Oxford Network, Burlington, and associates.

Metin Kiyak/Thinkstock

Although they discussed several possible influencing factors, the authors were unable to explain the associated benefits, costs, and harms associated with increased age and weight at discharge, which remain undetermined. Infants are separated a week longer than they were at the beginning of the study period, the prolonged effects of which cannot be underestimated, Dr. Edwards and colleagues observed in a large cohort study in Pediatrics.

A total of 314,811 infants 24-29 weeks’ gestational age who were admitted to 824 neonatal ICUs (NICUs) throughout the United States survived to initial discharge. The median postmenstrual age at hospital discharge was 38.3 weeks. Over the 14-year period from 2005 to 2018, unadjusted postmenstrual age at discharge increased a median 9 days, compared with a median adjusted age of 8 days.

Of the 273,109 infants initially discharged from the hospital to home, median weight at discharge was 2,600 g. Over the 14 years from 2005 to 2018, median unadjusted discharge weight increased 360 g, compared with median adjusted weight, which was estimated to have increased 316 g.

Median unadjusted z scores for weight increased 0.22 standard units over the 14-year period, compared with median adjusted z scores for weight at discharge, which increased an estimated 0.19 standard units.

The proportion of infants who were consuming human milk at discharge increased over the study period from 40% in 2005 to 48% in 2018. The use of cardiorespiratory monitors and oxygen decreased from 49% to 26%, and 27% to 22% respectively. The number of infants who were never transferred to specialized care before discharge to home also improved, from 71% to 76%.
 

Despite the unknowns, good news for managing pediatricians?

In a separate interview, study author Dr. Edwards noted that “infants born very preterm, who are discharged home from the NICU today, are larger and more physiologically mature than they were in 2005. Pediatricians will likely find this news to be positive as it may be easier to manage care for a more physiologically mature [infant],” and it may reduce risk of readmission.

“Infants stayed, on average, 8 days longer in 2018 than they did in 2005. That is 8 days when they were not at home with their families. Despite efforts by NICU teams to increase family-centered care, the NICU is not the same as being at home. ... That extra time in the NICU cost [some families] an estimated $28,000. ... As health care costs continue to rise, we need to understand the true cost [behind] this increase,” added Dr. Edwards, noting that more research is needed to understand what may be driving the increase in NICU length of stay and the possible implications. More research to investigate whether babies did better after discharge also is needed.

Going forward, Dr. Edwards indicated that she and her colleagues are exploring ways to measure apnea of prematurity (AOP) and use of continuous pulse oximetry (CPO) as the subject of future studies. In our study, we showed that the number of infants discharged home on a cardiorespiratory monitor decreased, but we do not know if that is explained by differences in management of AOP and CPO. “Understanding the influence of AOP and CPO management on discharge age would be an important contribution [to future research].”
 

AOP may drive increase in postmenstrual age

In an accompanying editorial, Cody Arnold, MD, and Alexis S. Davis, MD, said: “We have focused on apnea of prematurity and discharge countdowns in this commentary because we believe that changes in related practices are likely the most important drivers of the increases in postmenstrual age” reported by the authors in this study. “Other factors, such as increasing availability of NICU beds or decreasing availability of home support services, may have contributed to longer length of stay. But these questions should be answered by research, not by speculation,” said Dr. Arnold, neonatologist, University of Texas Health Sciences Center, Houston, and Dr. Davis, clinical associate professor, Stanford (Calif.) University.

“Prospective research comparing alternative countdown strategies on the basis of readmission rates and other outpatient outcomes is overdue.” Additional research is needed operationally to clearly outline parameters for countdown events, countdown duration, indications for CPO, outpatient caffeine use, and parental shared decision-making.”

The study was funded by the Vermont Oxford Network. Dr. Edwards received a grant from the Vermont Oxford Network; several others also had ties to the Network. Dr. Arnold and Dr. Davis had no conflicts of interest and reported no disclosures.

Gestational age and weight at discharge for infants aged 24-29 weeks increased steadily between 2005 and 2018, reported Erika M. Edwards, PhD, MPH, of the Vermont Oxford Network, Burlington, and associates.

Metin Kiyak/Thinkstock

Although they discussed several possible influencing factors, the authors were unable to explain the associated benefits, costs, and harms associated with increased age and weight at discharge, which remain undetermined. Infants are separated a week longer than they were at the beginning of the study period, the prolonged effects of which cannot be underestimated, Dr. Edwards and colleagues observed in a large cohort study in Pediatrics.

A total of 314,811 infants 24-29 weeks’ gestational age who were admitted to 824 neonatal ICUs (NICUs) throughout the United States survived to initial discharge. The median postmenstrual age at hospital discharge was 38.3 weeks. Over the 14-year period from 2005 to 2018, unadjusted postmenstrual age at discharge increased a median 9 days, compared with a median adjusted age of 8 days.

Of the 273,109 infants initially discharged from the hospital to home, median weight at discharge was 2,600 g. Over the 14 years from 2005 to 2018, median unadjusted discharge weight increased 360 g, compared with median adjusted weight, which was estimated to have increased 316 g.

Median unadjusted z scores for weight increased 0.22 standard units over the 14-year period, compared with median adjusted z scores for weight at discharge, which increased an estimated 0.19 standard units.

The proportion of infants who were consuming human milk at discharge increased over the study period from 40% in 2005 to 48% in 2018. The use of cardiorespiratory monitors and oxygen decreased from 49% to 26%, and 27% to 22% respectively. The number of infants who were never transferred to specialized care before discharge to home also improved, from 71% to 76%.
 

Despite the unknowns, good news for managing pediatricians?

In a separate interview, study author Dr. Edwards noted that “infants born very preterm, who are discharged home from the NICU today, are larger and more physiologically mature than they were in 2005. Pediatricians will likely find this news to be positive as it may be easier to manage care for a more physiologically mature [infant],” and it may reduce risk of readmission.

“Infants stayed, on average, 8 days longer in 2018 than they did in 2005. That is 8 days when they were not at home with their families. Despite efforts by NICU teams to increase family-centered care, the NICU is not the same as being at home. ... That extra time in the NICU cost [some families] an estimated $28,000. ... As health care costs continue to rise, we need to understand the true cost [behind] this increase,” added Dr. Edwards, noting that more research is needed to understand what may be driving the increase in NICU length of stay and the possible implications. More research to investigate whether babies did better after discharge also is needed.

Going forward, Dr. Edwards indicated that she and her colleagues are exploring ways to measure apnea of prematurity (AOP) and use of continuous pulse oximetry (CPO) as the subject of future studies. In our study, we showed that the number of infants discharged home on a cardiorespiratory monitor decreased, but we do not know if that is explained by differences in management of AOP and CPO. “Understanding the influence of AOP and CPO management on discharge age would be an important contribution [to future research].”
 

AOP may drive increase in postmenstrual age

In an accompanying editorial, Cody Arnold, MD, and Alexis S. Davis, MD, said: “We have focused on apnea of prematurity and discharge countdowns in this commentary because we believe that changes in related practices are likely the most important drivers of the increases in postmenstrual age” reported by the authors in this study. “Other factors, such as increasing availability of NICU beds or decreasing availability of home support services, may have contributed to longer length of stay. But these questions should be answered by research, not by speculation,” said Dr. Arnold, neonatologist, University of Texas Health Sciences Center, Houston, and Dr. Davis, clinical associate professor, Stanford (Calif.) University.

“Prospective research comparing alternative countdown strategies on the basis of readmission rates and other outpatient outcomes is overdue.” Additional research is needed operationally to clearly outline parameters for countdown events, countdown duration, indications for CPO, outpatient caffeine use, and parental shared decision-making.”

The study was funded by the Vermont Oxford Network. Dr. Edwards received a grant from the Vermont Oxford Network; several others also had ties to the Network. Dr. Arnold and Dr. Davis had no conflicts of interest and reported no disclosures.

Many medical practices turned to telemedicine when the pandemic shut down the economy last spring, but what do dermatology patients think about the socially distant approach?

The majority of patients, 55%, at one dermatology clinic agreed that teledermatology “was an adequate substitute for an in-person appointment” and 80% said that they would consider another such visit in the future, according to a survey conducted at George Washington University in Washington.

Although “telehealth is not without its drawbacks … it is clear from this study that the majority of patients feel positively towards teledermatology during the COVID-19 pandemic and [believe it] can be a suitable alternative for patients who are unable to meet with their providers in person,” Samuel Yeroushalmi, Sarah H. Millan, and associates at the university said in the Journal of Drugs in Dermatology.

When presented with a set of statements about the telehealth experience, the 168 survey respondents largely agreed that the overall appointment was satisfactory (80.8%), that minimal barriers were present (78.1%), and that the quality of care was similar to an in-person visit (62.5%), the investigators said.

Other factors, however, were not as well supported. Less than half (47.2%) of the respondents agreed that the telehealth appointments were more cost effective, and just over half (54.7%) agreed that they provided an adequate skin exam, they reported.

Of the set of 14 statements given to the patients – all of whom had at least one telehealth visit with the GW clinic between March 2 and June 17, 2020 – the one on the adequacy of the skin exam provided the largest share of disagreement at 27.1%, Mr. Yeroushalmi and Ms. Millan, medical students at the university and coauthors.

The lack of physical touch was mentioned most often (26.8%) when respondents were asked about their reasons for disliking telehealth visits, followed by the feeling that they had received an inadequate assessment (15.7%), they said.

Despite these drawbacks, “the convenience and efficacy of telehealth as well as its ability to maintain separation while social distancing recommendations are in place make it an effective way for dermatologists to continue to provide quality and safe care during the pandemics as well as during potential future public health crises,” the investigators concluded.

[email protected]

Many medical practices turned to telemedicine when the pandemic shut down the economy last spring, but what do dermatology patients think about the socially distant approach?

The majority of patients, 55%, at one dermatology clinic agreed that teledermatology “was an adequate substitute for an in-person appointment” and 80% said that they would consider another such visit in the future, according to a survey conducted at George Washington University in Washington.

Although “telehealth is not without its drawbacks … it is clear from this study that the majority of patients feel positively towards teledermatology during the COVID-19 pandemic and [believe it] can be a suitable alternative for patients who are unable to meet with their providers in person,” Samuel Yeroushalmi, Sarah H. Millan, and associates at the university said in the Journal of Drugs in Dermatology.

When presented with a set of statements about the telehealth experience, the 168 survey respondents largely agreed that the overall appointment was satisfactory (80.8%), that minimal barriers were present (78.1%), and that the quality of care was similar to an in-person visit (62.5%), the investigators said.

Other factors, however, were not as well supported. Less than half (47.2%) of the respondents agreed that the telehealth appointments were more cost effective, and just over half (54.7%) agreed that they provided an adequate skin exam, they reported.

Of the set of 14 statements given to the patients – all of whom had at least one telehealth visit with the GW clinic between March 2 and June 17, 2020 – the one on the adequacy of the skin exam provided the largest share of disagreement at 27.1%, Mr. Yeroushalmi and Ms. Millan, medical students at the university and coauthors.

The lack of physical touch was mentioned most often (26.8%) when respondents were asked about their reasons for disliking telehealth visits, followed by the feeling that they had received an inadequate assessment (15.7%), they said.

Despite these drawbacks, “the convenience and efficacy of telehealth as well as its ability to maintain separation while social distancing recommendations are in place make it an effective way for dermatologists to continue to provide quality and safe care during the pandemics as well as during potential future public health crises,” the investigators concluded.

[email protected]

Many medical practices turned to telemedicine when the pandemic shut down the economy last spring, but what do dermatology patients think about the socially distant approach?

The majority of patients, 55%, at one dermatology clinic agreed that teledermatology “was an adequate substitute for an in-person appointment” and 80% said that they would consider another such visit in the future, according to a survey conducted at George Washington University in Washington.

Although “telehealth is not without its drawbacks … it is clear from this study that the majority of patients feel positively towards teledermatology during the COVID-19 pandemic and [believe it] can be a suitable alternative for patients who are unable to meet with their providers in person,” Samuel Yeroushalmi, Sarah H. Millan, and associates at the university said in the Journal of Drugs in Dermatology.

When presented with a set of statements about the telehealth experience, the 168 survey respondents largely agreed that the overall appointment was satisfactory (80.8%), that minimal barriers were present (78.1%), and that the quality of care was similar to an in-person visit (62.5%), the investigators said.

Other factors, however, were not as well supported. Less than half (47.2%) of the respondents agreed that the telehealth appointments were more cost effective, and just over half (54.7%) agreed that they provided an adequate skin exam, they reported.

Of the set of 14 statements given to the patients – all of whom had at least one telehealth visit with the GW clinic between March 2 and June 17, 2020 – the one on the adequacy of the skin exam provided the largest share of disagreement at 27.1%, Mr. Yeroushalmi and Ms. Millan, medical students at the university and coauthors.

The lack of physical touch was mentioned most often (26.8%) when respondents were asked about their reasons for disliking telehealth visits, followed by the feeling that they had received an inadequate assessment (15.7%), they said.

Despite these drawbacks, “the convenience and efficacy of telehealth as well as its ability to maintain separation while social distancing recommendations are in place make it an effective way for dermatologists to continue to provide quality and safe care during the pandemics as well as during potential future public health crises,” the investigators concluded.

[email protected]

A commercial for the continuous glucose monitor (CGM) Dexcom G6 shown during the Super Bowl has provoked strong reactions in the diabetes community, both positive and negative.

The 30-second ad, which aired between the first two quarters of the American football game yesterday, features singer-songwriter-actor Nick Jonas, who has type 1 diabetes. During the ad, Mr. Jonas asks – with so much technology available today, including drones that deliver packages and self-driving cars – why are people with diabetes still pricking their fingers to test their blood sugar?

Mr. Jonas goes on to demonstrate the Dexcom G6 smartphone glucose app as it displays three different glucose levels including two trending upward, explaining: “It shows your glucose right in your phone, and where it’s heading, without fingersticks. Finally, technology that makes it easier to manage our diabetes.”

Diabetes type or insulin treatment are not mentioned in the ad, despite the fact that most insurance plans typically only cover CGMs for people with type 1 diabetes and sometimes for those with type 2 diabetes who take multiple daily insulin doses (given the risk for hypoglycemia).
 

Ad prompts mixed reaction on social media

Reactions rolled in on Twitter after the ad debuted Feb. 2, and then again after it aired during the game.

Some people who have type 1 diabetes themselves or have children with the disease who use the product were thrilled.

“Thanks to @NickJonas for his advocacy on T1. My 11-year old has been on the Dexcom for 3 weeks. For a newly diagnosed kid, it removes a lot of anxiety (and for his parents, too!) Plus, he is thrilled his meter has a Super Bowl commercial!” tweeted @KatisJewell.

Another positive tweet, from @rturnerroy, read: “@nickjonas Thank you for bringing representation to #type1diabetes. And hey #Dexcom, you’re the best.”

But many others were critical, both of Jonas and Dexcom. @hb_herrick tweeted: “Diabetes awareness is fantastic. Dexcom being able to afford Nick Jonas for a #SuperBowl commercial is not. This is a health care product. Make it more affordable for those who need it.”

Another Twitter user, @universeofdust, tweeted: “Feeling ambivalent about the #Dexcom ad tbh. I love the awareness & representation. But also not a big fan of dexcom spending $5.5 mill+ to make the CGM seem like this ~cool & trendy~ thing when many type 1s can’t afford their insulin, let alone a CGM.”

And @andricheli wrote: “Only people lucky enough to have excellent insurance and be able to afford the out-of-pocket costs have access. Many others do not.”

And in another tweet the same user said, “The #Dexcom is an amazing device. It’s literally lifesaving and life extending. But it’s also very expensive and not available to everyone. Maybe instead of spending $5 mil on a Super Bowl ad, @dexcom should spend that on getting Dex into the handle of people who need it.”

Others, including @1hitwonderdate, criticized Mr. Jonas directly, asking him: “As someone who has struggled with diabetes and is trying to support themselves along with millions of others, why not use this platform to help those who can’t afford their supplies or are rationing them?!”


 

Dexcom and Jonas’ organization respond

This news organization reached out to both Dexcom and to Beyond Type 1, a nonprofit organization cofounded by Mr. Jonas, for comment. Both emailed responses.

Regarding the intended audience for the ad, Dexcom acknowledged that it hoped to reach a much wider group than just people with type 1 diabetes or even just insulin users.

“We believe our CGM technology has the ability to empower any person with diabetes and significantly improve their treatment and quality of life, whether they are using insulin or not,” the company said, adding that the ad was also aimed at “loved ones, caregivers, and even health care professionals who need to know about this technology.”

According to Dexcom, the G6 is covered by 99% of commercial insurance in the United States, in addition to Medicare, and by Medicaid in more than 40 states. Over 70% of Dexcom patients with pharmacy coverage in the United States pay under $60 per month for CGM, and a third pay $0 out-of-pocket.

“That said, we know there’s more to be done to improve access, and we are working with several partners to broaden access to Dexcom CGM, especially for people with type 2 diabetes not on mealtime insulin,” the company noted.

Beyond Type 1 responded to the criticisms about Mr. Jonas personally, noting that the celebrity is, in fact, heavily involved in advocacy.

“Nick was involved in the launch of GetInsulin.org this past October,” they said. “GetInsulin.org is a tool created by Beyond Type 1 to connect people with diabetes in the United States to the insulin access and affordability options that match their unique circumstances. ... Beyond Type 1 will continue driving awareness of short-term solutions related to insulin access and affordability while fighting for systemic change.”

The organization “is also advocating for systemic payment policies that will make devices less expensive and avoid the same pitfalls (and rising prices) as the drug pricing system in the U.S.”

Mr. Jonas himself appears aware of the concerns.

Is 2021’s most expensive Super Bowl ad justified?

Meanwhile, in a piece in Esquire, Dave Holmes, who has type 1 diabetes, weighs up the pros and cons of the ad.

He writes: “While Jonas makes it look fun and easy to use a Dexcom G6 – a program to just get with like you would a drone or LED eyelashes – the process of acquiring one is complicated and often very expensive, even for people with good insurance. Which makes the year’s most expensive ad buy, for a product that only a small percentage of the U.S. population needs, confusing to me and others.”

Mr. Holmes also spoke with Craig Stubing, founder of the Beta Cell Foundation, a nonprofit that aims to educate and empower those with type 1 diabetes.

“Spending all this money on an ad, when people’s lives are at stake. I don’t know if offensive is the right word, but it seems out of touch with the reality that their patients are facing,” Mr. Stubing told Mr. Holmes.

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

A commercial for the continuous glucose monitor (CGM) Dexcom G6 shown during the Super Bowl has provoked strong reactions in the diabetes community, both positive and negative.

The 30-second ad, which aired between the first two quarters of the American football game yesterday, features singer-songwriter-actor Nick Jonas, who has type 1 diabetes. During the ad, Mr. Jonas asks – with so much technology available today, including drones that deliver packages and self-driving cars – why are people with diabetes still pricking their fingers to test their blood sugar?

Mr. Jonas goes on to demonstrate the Dexcom G6 smartphone glucose app as it displays three different glucose levels including two trending upward, explaining: “It shows your glucose right in your phone, and where it’s heading, without fingersticks. Finally, technology that makes it easier to manage our diabetes.”

Diabetes type or insulin treatment are not mentioned in the ad, despite the fact that most insurance plans typically only cover CGMs for people with type 1 diabetes and sometimes for those with type 2 diabetes who take multiple daily insulin doses (given the risk for hypoglycemia).
 

Ad prompts mixed reaction on social media

Reactions rolled in on Twitter after the ad debuted Feb. 2, and then again after it aired during the game.

Some people who have type 1 diabetes themselves or have children with the disease who use the product were thrilled.

“Thanks to @NickJonas for his advocacy on T1. My 11-year old has been on the Dexcom for 3 weeks. For a newly diagnosed kid, it removes a lot of anxiety (and for his parents, too!) Plus, he is thrilled his meter has a Super Bowl commercial!” tweeted @KatisJewell.

Another positive tweet, from @rturnerroy, read: “@nickjonas Thank you for bringing representation to #type1diabetes. And hey #Dexcom, you’re the best.”

But many others were critical, both of Jonas and Dexcom. @hb_herrick tweeted: “Diabetes awareness is fantastic. Dexcom being able to afford Nick Jonas for a #SuperBowl commercial is not. This is a health care product. Make it more affordable for those who need it.”

Another Twitter user, @universeofdust, tweeted: “Feeling ambivalent about the #Dexcom ad tbh. I love the awareness & representation. But also not a big fan of dexcom spending $5.5 mill+ to make the CGM seem like this ~cool & trendy~ thing when many type 1s can’t afford their insulin, let alone a CGM.”

And @andricheli wrote: “Only people lucky enough to have excellent insurance and be able to afford the out-of-pocket costs have access. Many others do not.”

And in another tweet the same user said, “The #Dexcom is an amazing device. It’s literally lifesaving and life extending. But it’s also very expensive and not available to everyone. Maybe instead of spending $5 mil on a Super Bowl ad, @dexcom should spend that on getting Dex into the handle of people who need it.”

Others, including @1hitwonderdate, criticized Mr. Jonas directly, asking him: “As someone who has struggled with diabetes and is trying to support themselves along with millions of others, why not use this platform to help those who can’t afford their supplies or are rationing them?!”


 

Dexcom and Jonas’ organization respond

This news organization reached out to both Dexcom and to Beyond Type 1, a nonprofit organization cofounded by Mr. Jonas, for comment. Both emailed responses.

Regarding the intended audience for the ad, Dexcom acknowledged that it hoped to reach a much wider group than just people with type 1 diabetes or even just insulin users.

“We believe our CGM technology has the ability to empower any person with diabetes and significantly improve their treatment and quality of life, whether they are using insulin or not,” the company said, adding that the ad was also aimed at “loved ones, caregivers, and even health care professionals who need to know about this technology.”

According to Dexcom, the G6 is covered by 99% of commercial insurance in the United States, in addition to Medicare, and by Medicaid in more than 40 states. Over 70% of Dexcom patients with pharmacy coverage in the United States pay under $60 per month for CGM, and a third pay $0 out-of-pocket.

“That said, we know there’s more to be done to improve access, and we are working with several partners to broaden access to Dexcom CGM, especially for people with type 2 diabetes not on mealtime insulin,” the company noted.

Beyond Type 1 responded to the criticisms about Mr. Jonas personally, noting that the celebrity is, in fact, heavily involved in advocacy.

“Nick was involved in the launch of GetInsulin.org this past October,” they said. “GetInsulin.org is a tool created by Beyond Type 1 to connect people with diabetes in the United States to the insulin access and affordability options that match their unique circumstances. ... Beyond Type 1 will continue driving awareness of short-term solutions related to insulin access and affordability while fighting for systemic change.”

The organization “is also advocating for systemic payment policies that will make devices less expensive and avoid the same pitfalls (and rising prices) as the drug pricing system in the U.S.”

Mr. Jonas himself appears aware of the concerns.

Is 2021’s most expensive Super Bowl ad justified?

Meanwhile, in a piece in Esquire, Dave Holmes, who has type 1 diabetes, weighs up the pros and cons of the ad.

He writes: “While Jonas makes it look fun and easy to use a Dexcom G6 – a program to just get with like you would a drone or LED eyelashes – the process of acquiring one is complicated and often very expensive, even for people with good insurance. Which makes the year’s most expensive ad buy, for a product that only a small percentage of the U.S. population needs, confusing to me and others.”

Mr. Holmes also spoke with Craig Stubing, founder of the Beta Cell Foundation, a nonprofit that aims to educate and empower those with type 1 diabetes.

“Spending all this money on an ad, when people’s lives are at stake. I don’t know if offensive is the right word, but it seems out of touch with the reality that their patients are facing,” Mr. Stubing told Mr. Holmes.

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

A commercial for the continuous glucose monitor (CGM) Dexcom G6 shown during the Super Bowl has provoked strong reactions in the diabetes community, both positive and negative.

The 30-second ad, which aired between the first two quarters of the American football game yesterday, features singer-songwriter-actor Nick Jonas, who has type 1 diabetes. During the ad, Mr. Jonas asks – with so much technology available today, including drones that deliver packages and self-driving cars – why are people with diabetes still pricking their fingers to test their blood sugar?

Mr. Jonas goes on to demonstrate the Dexcom G6 smartphone glucose app as it displays three different glucose levels including two trending upward, explaining: “It shows your glucose right in your phone, and where it’s heading, without fingersticks. Finally, technology that makes it easier to manage our diabetes.”

Diabetes type or insulin treatment are not mentioned in the ad, despite the fact that most insurance plans typically only cover CGMs for people with type 1 diabetes and sometimes for those with type 2 diabetes who take multiple daily insulin doses (given the risk for hypoglycemia).
 

Ad prompts mixed reaction on social media

Reactions rolled in on Twitter after the ad debuted Feb. 2, and then again after it aired during the game.

Some people who have type 1 diabetes themselves or have children with the disease who use the product were thrilled.

“Thanks to @NickJonas for his advocacy on T1. My 11-year old has been on the Dexcom for 3 weeks. For a newly diagnosed kid, it removes a lot of anxiety (and for his parents, too!) Plus, he is thrilled his meter has a Super Bowl commercial!” tweeted @KatisJewell.

Another positive tweet, from @rturnerroy, read: “@nickjonas Thank you for bringing representation to #type1diabetes. And hey #Dexcom, you’re the best.”

But many others were critical, both of Jonas and Dexcom. @hb_herrick tweeted: “Diabetes awareness is fantastic. Dexcom being able to afford Nick Jonas for a #SuperBowl commercial is not. This is a health care product. Make it more affordable for those who need it.”

Another Twitter user, @universeofdust, tweeted: “Feeling ambivalent about the #Dexcom ad tbh. I love the awareness & representation. But also not a big fan of dexcom spending $5.5 mill+ to make the CGM seem like this ~cool & trendy~ thing when many type 1s can’t afford their insulin, let alone a CGM.”

And @andricheli wrote: “Only people lucky enough to have excellent insurance and be able to afford the out-of-pocket costs have access. Many others do not.”

And in another tweet the same user said, “The #Dexcom is an amazing device. It’s literally lifesaving and life extending. But it’s also very expensive and not available to everyone. Maybe instead of spending $5 mil on a Super Bowl ad, @dexcom should spend that on getting Dex into the handle of people who need it.”

Others, including @1hitwonderdate, criticized Mr. Jonas directly, asking him: “As someone who has struggled with diabetes and is trying to support themselves along with millions of others, why not use this platform to help those who can’t afford their supplies or are rationing them?!”


 

Dexcom and Jonas’ organization respond

This news organization reached out to both Dexcom and to Beyond Type 1, a nonprofit organization cofounded by Mr. Jonas, for comment. Both emailed responses.

Regarding the intended audience for the ad, Dexcom acknowledged that it hoped to reach a much wider group than just people with type 1 diabetes or even just insulin users.

“We believe our CGM technology has the ability to empower any person with diabetes and significantly improve their treatment and quality of life, whether they are using insulin or not,” the company said, adding that the ad was also aimed at “loved ones, caregivers, and even health care professionals who need to know about this technology.”

According to Dexcom, the G6 is covered by 99% of commercial insurance in the United States, in addition to Medicare, and by Medicaid in more than 40 states. Over 70% of Dexcom patients with pharmacy coverage in the United States pay under $60 per month for CGM, and a third pay $0 out-of-pocket.

“That said, we know there’s more to be done to improve access, and we are working with several partners to broaden access to Dexcom CGM, especially for people with type 2 diabetes not on mealtime insulin,” the company noted.

Beyond Type 1 responded to the criticisms about Mr. Jonas personally, noting that the celebrity is, in fact, heavily involved in advocacy.

“Nick was involved in the launch of GetInsulin.org this past October,” they said. “GetInsulin.org is a tool created by Beyond Type 1 to connect people with diabetes in the United States to the insulin access and affordability options that match their unique circumstances. ... Beyond Type 1 will continue driving awareness of short-term solutions related to insulin access and affordability while fighting for systemic change.”

The organization “is also advocating for systemic payment policies that will make devices less expensive and avoid the same pitfalls (and rising prices) as the drug pricing system in the U.S.”

Mr. Jonas himself appears aware of the concerns.

Is 2021’s most expensive Super Bowl ad justified?

Meanwhile, in a piece in Esquire, Dave Holmes, who has type 1 diabetes, weighs up the pros and cons of the ad.

He writes: “While Jonas makes it look fun and easy to use a Dexcom G6 – a program to just get with like you would a drone or LED eyelashes – the process of acquiring one is complicated and often very expensive, even for people with good insurance. Which makes the year’s most expensive ad buy, for a product that only a small percentage of the U.S. population needs, confusing to me and others.”

Mr. Holmes also spoke with Craig Stubing, founder of the Beta Cell Foundation, a nonprofit that aims to educate and empower those with type 1 diabetes.

“Spending all this money on an ad, when people’s lives are at stake. I don’t know if offensive is the right word, but it seems out of touch with the reality that their patients are facing,” Mr. Stubing told Mr. Holmes.

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

Way back in the spring of last year, I wrote about a pandemic of posttraumatic stress disorder that would descend upon us because of COVID-19. At the time, we were told that, by summer – June or July 2020 – all the steps we needed to take to stay ahead of the virus, including remaining socially distant, and yes, even wearing masks, would be over. Life would get back to normal.

Little did we know that a national plan for our safety, including making sure that we had enough masks and PPE, would not be forthcoming, and that so many thousands of Americans would perish, leaving millions of distraught families and friends.

So many people are suffering. Mothers, for example, are struggling to balance remote schooling with additional child care and domestic work. More than 2 million women left the U.S. workforce last year between February 2020 and October 2020, according to a report by the National Women’s Law Center. Even before COVID-19, loneliness among young adults was considered a domestic epidemic – and the social isolation forced by the pandemic has worsened those trends, research shows. These trends are creating so much more anxiety, depression, despair, and yes, even PTSD. As mental health professionals, we have a lot of work to do in educating people about coping skills and in providing treatments when appropriate.
 

Experiences take on new meaning

One day a friend and professional colleague called me, and he sounded quite distraught. He had not been able to reach his primary care physician and thought that, as a physician, I might have some insights about his symptoms. He began telling me that something really strange was happening whenever he walked around outside with his mask on. He couldn’t breathe with it on, he told me. In addition, his eyes teared up, his nose started running, and his eyeglasses fogged up so much that he couldn’t see where he was going. He was really anxious, nervous, and felt a great sense of despair – and disorientation. He did not fully understand what was happening and didn’t know whether those disorienting symptoms were mask-related or whether he was incubating some yet undiagnosed illness.

I addressed his concerns in the moment by assuring him that I, too, had been experiencing similar challenges with fogged-up glasses and a runny nose; many people were experiencing some of the same things. I explained that even I had called an allergist to find out whether I might be allergic to some component in the mask and whether he had seen those symptoms in his practice.

Albeit, those issues tied to masks are relatively minor, compared with the enormous psychological toll this pandemic has taken on some people. But it’s clear that different people suffer different effects in light of the marked changes in life and lifestyles caused by the pandemic.
 

‘It’s something else’

Two people I know, both professionals, recently told me that in their social lives they constantly feel tired and anxious, and that their concentration has diminished. They worry more about their futures, they told me separately. (They don’t know each other.) They reported going through daily life “like being on automatic.” Both said they were far too irritable and reported feeling that social isolation had dulled their thinking.

They said they were not depressed; “it’s something else.” I reassured them both that this would pass with time and suggested that they work at not socially isolating – to the extent that they can – during the pandemic. I also encouraged them to get vaccinated and to talk with a professional if their malaise was altering their level of functioning.

So far, more than 475,000 people in the United States have died of COVID-19, and thousands continue to suffer. People are saying goodbye to loved ones on iPads, and watching news stories about hospitals at overcapacity and refrigeration units storing bodies. Meanwhile, health care workers, many of whom are putting their lives and those of their families at risk, are reporting increased levels of burnout – and moral injury.
 

Value of relaxation techniques

We know that the latest mitigation measures advised by the Centers for Disease Control and Prevention must continue during the COVID-19 vaccination process. The new CDC guidelines on the value of double masking make sense and should be followed. However, even as we learn more about the virus and how to stop its spread, we must recognize that social distancing is not the same as social isolation. We must continue to do what we can to maintain social relationships and keep open the lines of communication, including the use of virtual tools. I am pleased to see the growth of telemedicine during the pandemic. When applicable, telemedicine allows greater medical and mental health care without the stress of travel and the risk of exposure to more people than necessary.

It’s important to teach our patients – and our friends – relaxation techniques, whether it’s hypnosis, mindfulness, transcendental meditation, or deep breathing exercises. For the more advanced therapies, guided imagery can help patients develop a sense of calm and equanimity.

For those who are not skilled in relaxation techniques, YouTube offers some excellent programs that teach relaxation and mindfulness. Another thing I do is talk regularly with people I know and sometimes with people I know I’ll disagree with – just to keep my brain active. I also try to learn new things in my spare time to establish new brain pathways and stay mentally active.

The pain and grief tied to the pandemic are unlike anything we’ve ever experienced. Our training as psychiatrists, psychologists, and other mental health care professionals makes us all uniquely suited to assist patients as they process these traumatic times. We must step forward and do so.
 

Dr. London is a practicing psychiatrist and has been a newspaper columnist for 35 years, specializing in and writing about short-term therapy, including cognitive-behavioral therapy and guided imagery. He is author of “Find Freedom Fast” (Kettlehole Publishing, 2019). He has no conflicts of interest.

Way back in the spring of last year, I wrote about a pandemic of posttraumatic stress disorder that would descend upon us because of COVID-19. At the time, we were told that, by summer – June or July 2020 – all the steps we needed to take to stay ahead of the virus, including remaining socially distant, and yes, even wearing masks, would be over. Life would get back to normal.

Little did we know that a national plan for our safety, including making sure that we had enough masks and PPE, would not be forthcoming, and that so many thousands of Americans would perish, leaving millions of distraught families and friends.

So many people are suffering. Mothers, for example, are struggling to balance remote schooling with additional child care and domestic work. More than 2 million women left the U.S. workforce last year between February 2020 and October 2020, according to a report by the National Women’s Law Center. Even before COVID-19, loneliness among young adults was considered a domestic epidemic – and the social isolation forced by the pandemic has worsened those trends, research shows. These trends are creating so much more anxiety, depression, despair, and yes, even PTSD. As mental health professionals, we have a lot of work to do in educating people about coping skills and in providing treatments when appropriate.
 

Experiences take on new meaning

One day a friend and professional colleague called me, and he sounded quite distraught. He had not been able to reach his primary care physician and thought that, as a physician, I might have some insights about his symptoms. He began telling me that something really strange was happening whenever he walked around outside with his mask on. He couldn’t breathe with it on, he told me. In addition, his eyes teared up, his nose started running, and his eyeglasses fogged up so much that he couldn’t see where he was going. He was really anxious, nervous, and felt a great sense of despair – and disorientation. He did not fully understand what was happening and didn’t know whether those disorienting symptoms were mask-related or whether he was incubating some yet undiagnosed illness.

I addressed his concerns in the moment by assuring him that I, too, had been experiencing similar challenges with fogged-up glasses and a runny nose; many people were experiencing some of the same things. I explained that even I had called an allergist to find out whether I might be allergic to some component in the mask and whether he had seen those symptoms in his practice.

Albeit, those issues tied to masks are relatively minor, compared with the enormous psychological toll this pandemic has taken on some people. But it’s clear that different people suffer different effects in light of the marked changes in life and lifestyles caused by the pandemic.
 

‘It’s something else’

Two people I know, both professionals, recently told me that in their social lives they constantly feel tired and anxious, and that their concentration has diminished. They worry more about their futures, they told me separately. (They don’t know each other.) They reported going through daily life “like being on automatic.” Both said they were far too irritable and reported feeling that social isolation had dulled their thinking.

They said they were not depressed; “it’s something else.” I reassured them both that this would pass with time and suggested that they work at not socially isolating – to the extent that they can – during the pandemic. I also encouraged them to get vaccinated and to talk with a professional if their malaise was altering their level of functioning.

So far, more than 475,000 people in the United States have died of COVID-19, and thousands continue to suffer. People are saying goodbye to loved ones on iPads, and watching news stories about hospitals at overcapacity and refrigeration units storing bodies. Meanwhile, health care workers, many of whom are putting their lives and those of their families at risk, are reporting increased levels of burnout – and moral injury.
 

Value of relaxation techniques

We know that the latest mitigation measures advised by the Centers for Disease Control and Prevention must continue during the COVID-19 vaccination process. The new CDC guidelines on the value of double masking make sense and should be followed. However, even as we learn more about the virus and how to stop its spread, we must recognize that social distancing is not the same as social isolation. We must continue to do what we can to maintain social relationships and keep open the lines of communication, including the use of virtual tools. I am pleased to see the growth of telemedicine during the pandemic. When applicable, telemedicine allows greater medical and mental health care without the stress of travel and the risk of exposure to more people than necessary.

It’s important to teach our patients – and our friends – relaxation techniques, whether it’s hypnosis, mindfulness, transcendental meditation, or deep breathing exercises. For the more advanced therapies, guided imagery can help patients develop a sense of calm and equanimity.

For those who are not skilled in relaxation techniques, YouTube offers some excellent programs that teach relaxation and mindfulness. Another thing I do is talk regularly with people I know and sometimes with people I know I’ll disagree with – just to keep my brain active. I also try to learn new things in my spare time to establish new brain pathways and stay mentally active.

The pain and grief tied to the pandemic are unlike anything we’ve ever experienced. Our training as psychiatrists, psychologists, and other mental health care professionals makes us all uniquely suited to assist patients as they process these traumatic times. We must step forward and do so.
 

Dr. London is a practicing psychiatrist and has been a newspaper columnist for 35 years, specializing in and writing about short-term therapy, including cognitive-behavioral therapy and guided imagery. He is author of “Find Freedom Fast” (Kettlehole Publishing, 2019). He has no conflicts of interest.

Way back in the spring of last year, I wrote about a pandemic of posttraumatic stress disorder that would descend upon us because of COVID-19. At the time, we were told that, by summer – June or July 2020 – all the steps we needed to take to stay ahead of the virus, including remaining socially distant, and yes, even wearing masks, would be over. Life would get back to normal.

Little did we know that a national plan for our safety, including making sure that we had enough masks and PPE, would not be forthcoming, and that so many thousands of Americans would perish, leaving millions of distraught families and friends.

So many people are suffering. Mothers, for example, are struggling to balance remote schooling with additional child care and domestic work. More than 2 million women left the U.S. workforce last year between February 2020 and October 2020, according to a report by the National Women’s Law Center. Even before COVID-19, loneliness among young adults was considered a domestic epidemic – and the social isolation forced by the pandemic has worsened those trends, research shows. These trends are creating so much more anxiety, depression, despair, and yes, even PTSD. As mental health professionals, we have a lot of work to do in educating people about coping skills and in providing treatments when appropriate.
 

Experiences take on new meaning

One day a friend and professional colleague called me, and he sounded quite distraught. He had not been able to reach his primary care physician and thought that, as a physician, I might have some insights about his symptoms. He began telling me that something really strange was happening whenever he walked around outside with his mask on. He couldn’t breathe with it on, he told me. In addition, his eyes teared up, his nose started running, and his eyeglasses fogged up so much that he couldn’t see where he was going. He was really anxious, nervous, and felt a great sense of despair – and disorientation. He did not fully understand what was happening and didn’t know whether those disorienting symptoms were mask-related or whether he was incubating some yet undiagnosed illness.

I addressed his concerns in the moment by assuring him that I, too, had been experiencing similar challenges with fogged-up glasses and a runny nose; many people were experiencing some of the same things. I explained that even I had called an allergist to find out whether I might be allergic to some component in the mask and whether he had seen those symptoms in his practice.

Albeit, those issues tied to masks are relatively minor, compared with the enormous psychological toll this pandemic has taken on some people. But it’s clear that different people suffer different effects in light of the marked changes in life and lifestyles caused by the pandemic.
 

‘It’s something else’

Two people I know, both professionals, recently told me that in their social lives they constantly feel tired and anxious, and that their concentration has diminished. They worry more about their futures, they told me separately. (They don’t know each other.) They reported going through daily life “like being on automatic.” Both said they were far too irritable and reported feeling that social isolation had dulled their thinking.

They said they were not depressed; “it’s something else.” I reassured them both that this would pass with time and suggested that they work at not socially isolating – to the extent that they can – during the pandemic. I also encouraged them to get vaccinated and to talk with a professional if their malaise was altering their level of functioning.

So far, more than 475,000 people in the United States have died of COVID-19, and thousands continue to suffer. People are saying goodbye to loved ones on iPads, and watching news stories about hospitals at overcapacity and refrigeration units storing bodies. Meanwhile, health care workers, many of whom are putting their lives and those of their families at risk, are reporting increased levels of burnout – and moral injury.
 

Value of relaxation techniques

We know that the latest mitigation measures advised by the Centers for Disease Control and Prevention must continue during the COVID-19 vaccination process. The new CDC guidelines on the value of double masking make sense and should be followed. However, even as we learn more about the virus and how to stop its spread, we must recognize that social distancing is not the same as social isolation. We must continue to do what we can to maintain social relationships and keep open the lines of communication, including the use of virtual tools. I am pleased to see the growth of telemedicine during the pandemic. When applicable, telemedicine allows greater medical and mental health care without the stress of travel and the risk of exposure to more people than necessary.

It’s important to teach our patients – and our friends – relaxation techniques, whether it’s hypnosis, mindfulness, transcendental meditation, or deep breathing exercises. For the more advanced therapies, guided imagery can help patients develop a sense of calm and equanimity.

For those who are not skilled in relaxation techniques, YouTube offers some excellent programs that teach relaxation and mindfulness. Another thing I do is talk regularly with people I know and sometimes with people I know I’ll disagree with – just to keep my brain active. I also try to learn new things in my spare time to establish new brain pathways and stay mentally active.

The pain and grief tied to the pandemic are unlike anything we’ve ever experienced. Our training as psychiatrists, psychologists, and other mental health care professionals makes us all uniquely suited to assist patients as they process these traumatic times. We must step forward and do so.
 

Dr. London is a practicing psychiatrist and has been a newspaper columnist for 35 years, specializing in and writing about short-term therapy, including cognitive-behavioral therapy and guided imagery. He is author of “Find Freedom Fast” (Kettlehole Publishing, 2019). He has no conflicts of interest.

Combination antiretroviral therapy (cART) has shifted HIV infection from a fatal to a chronic condition. New evidence now suggests this has been accompanied by a shift in the profile of HIV-related brain abnormalities beyond the basal ganglia, frequently implicated in the pre-cART era, to limbic structures.

“This shift in subcortical signatures may be contributing to the increasing range of neuropsychiatric and cognitive outcomes,” write Neda Jahanshad, PhD, University of Southern California, Los Angeles, and colleagues.

The study was published online Jan. 15 in JAMA Network Open.
 

Brain signature of HIV

The researchers with the HIV Working Group within the Enhancing Neuro Imaging Genetics Through Meta Analysis (ENIGMA) consortium examined structural brain associations with CD4+ T cell counts and HIV viral load.

These clinical markers are the most consistently available in studies of HIV and generalize across demographically and clinically diverse HIV-infected individuals, they point out. However, the degree to which they capture central nervous system injury is not fully understood.

In this cross-sectional study of 1,203 HIV-infected adults from 13 HIV neuroimaging studies, a lower CD4+ T-cell count was associated with smaller hippocampal and thalamic volume independent of treatment status. However, in a subset of adults not on cART, a lower CD4+ T-cell count was associated with smaller putamen volume.

Across all participants, detectable viral load was associated with smaller hippocampal volume, but in the subset on cART, detectable viral load was also associated with smaller amygdala volume.

The findings indicate that plasma markers universally used to monitor immune function and response to treatment in patients with HIV infection are associated with subcortical brain volume.

“Our findings,” they add, “extend beyond the classically implicated regions of the basal ganglia and may represent a generalizable brain signature of HIV infection in the cART era.”

A limitation of the analysis is that most of the participants were men (n = 880, 73%). “A more extensive international effort assessing the neurologic effects of HIV infection in women is needed,” they conclude.

This analysis, they add, demonstrates the feasibility and utility of a global collaborative initiative to understand the neurologic signatures of HIV infection. They invite other HIV researchers to join the ENIGMA-HIV consortium.

“With a greater collaborative effort, we will be able to assess factors that may modulate neurologic outcomes, including cART treatment regimens, comorbidities, coinfections, substance use, socioeconomic factors, and demographic factors, as well as the functional implications of such structural brain differences, in well-powered analyses,” the researchers say.

“Understanding the neurobiological changes that may contribute to neuropsychiatric and cognitive outcomes in HIV-positive individuals is critical for identifying individuals at risk for neurologic symptoms, driving novel treatments that may protect the CNS, and monitoring treatment response,” they add.

Support for this research was provided by grants from the National Institutes of Health, the SA Medical Research Council, the National Health and Medical Research Council, and the European Research Council. Dr. Jahanshad received partial research support from Biogen for work unrelated to the topic of this article. A complete list of author disclosures is in the original article.

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

Combination antiretroviral therapy (cART) has shifted HIV infection from a fatal to a chronic condition. New evidence now suggests this has been accompanied by a shift in the profile of HIV-related brain abnormalities beyond the basal ganglia, frequently implicated in the pre-cART era, to limbic structures.

“This shift in subcortical signatures may be contributing to the increasing range of neuropsychiatric and cognitive outcomes,” write Neda Jahanshad, PhD, University of Southern California, Los Angeles, and colleagues.

The study was published online Jan. 15 in JAMA Network Open.
 

Brain signature of HIV

The researchers with the HIV Working Group within the Enhancing Neuro Imaging Genetics Through Meta Analysis (ENIGMA) consortium examined structural brain associations with CD4+ T cell counts and HIV viral load.

These clinical markers are the most consistently available in studies of HIV and generalize across demographically and clinically diverse HIV-infected individuals, they point out. However, the degree to which they capture central nervous system injury is not fully understood.

In this cross-sectional study of 1,203 HIV-infected adults from 13 HIV neuroimaging studies, a lower CD4+ T-cell count was associated with smaller hippocampal and thalamic volume independent of treatment status. However, in a subset of adults not on cART, a lower CD4+ T-cell count was associated with smaller putamen volume.

Across all participants, detectable viral load was associated with smaller hippocampal volume, but in the subset on cART, detectable viral load was also associated with smaller amygdala volume.

The findings indicate that plasma markers universally used to monitor immune function and response to treatment in patients with HIV infection are associated with subcortical brain volume.

“Our findings,” they add, “extend beyond the classically implicated regions of the basal ganglia and may represent a generalizable brain signature of HIV infection in the cART era.”

A limitation of the analysis is that most of the participants were men (n = 880, 73%). “A more extensive international effort assessing the neurologic effects of HIV infection in women is needed,” they conclude.

This analysis, they add, demonstrates the feasibility and utility of a global collaborative initiative to understand the neurologic signatures of HIV infection. They invite other HIV researchers to join the ENIGMA-HIV consortium.

“With a greater collaborative effort, we will be able to assess factors that may modulate neurologic outcomes, including cART treatment regimens, comorbidities, coinfections, substance use, socioeconomic factors, and demographic factors, as well as the functional implications of such structural brain differences, in well-powered analyses,” the researchers say.

“Understanding the neurobiological changes that may contribute to neuropsychiatric and cognitive outcomes in HIV-positive individuals is critical for identifying individuals at risk for neurologic symptoms, driving novel treatments that may protect the CNS, and monitoring treatment response,” they add.

Support for this research was provided by grants from the National Institutes of Health, the SA Medical Research Council, the National Health and Medical Research Council, and the European Research Council. Dr. Jahanshad received partial research support from Biogen for work unrelated to the topic of this article. A complete list of author disclosures is in the original article.

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

Combination antiretroviral therapy (cART) has shifted HIV infection from a fatal to a chronic condition. New evidence now suggests this has been accompanied by a shift in the profile of HIV-related brain abnormalities beyond the basal ganglia, frequently implicated in the pre-cART era, to limbic structures.

“This shift in subcortical signatures may be contributing to the increasing range of neuropsychiatric and cognitive outcomes,” write Neda Jahanshad, PhD, University of Southern California, Los Angeles, and colleagues.

The study was published online Jan. 15 in JAMA Network Open.
 

Brain signature of HIV

The researchers with the HIV Working Group within the Enhancing Neuro Imaging Genetics Through Meta Analysis (ENIGMA) consortium examined structural brain associations with CD4+ T cell counts and HIV viral load.

These clinical markers are the most consistently available in studies of HIV and generalize across demographically and clinically diverse HIV-infected individuals, they point out. However, the degree to which they capture central nervous system injury is not fully understood.

In this cross-sectional study of 1,203 HIV-infected adults from 13 HIV neuroimaging studies, a lower CD4+ T-cell count was associated with smaller hippocampal and thalamic volume independent of treatment status. However, in a subset of adults not on cART, a lower CD4+ T-cell count was associated with smaller putamen volume.

Across all participants, detectable viral load was associated with smaller hippocampal volume, but in the subset on cART, detectable viral load was also associated with smaller amygdala volume.

The findings indicate that plasma markers universally used to monitor immune function and response to treatment in patients with HIV infection are associated with subcortical brain volume.

“Our findings,” they add, “extend beyond the classically implicated regions of the basal ganglia and may represent a generalizable brain signature of HIV infection in the cART era.”

A limitation of the analysis is that most of the participants were men (n = 880, 73%). “A more extensive international effort assessing the neurologic effects of HIV infection in women is needed,” they conclude.

This analysis, they add, demonstrates the feasibility and utility of a global collaborative initiative to understand the neurologic signatures of HIV infection. They invite other HIV researchers to join the ENIGMA-HIV consortium.

“With a greater collaborative effort, we will be able to assess factors that may modulate neurologic outcomes, including cART treatment regimens, comorbidities, coinfections, substance use, socioeconomic factors, and demographic factors, as well as the functional implications of such structural brain differences, in well-powered analyses,” the researchers say.

“Understanding the neurobiological changes that may contribute to neuropsychiatric and cognitive outcomes in HIV-positive individuals is critical for identifying individuals at risk for neurologic symptoms, driving novel treatments that may protect the CNS, and monitoring treatment response,” they add.

Support for this research was provided by grants from the National Institutes of Health, the SA Medical Research Council, the National Health and Medical Research Council, and the European Research Council. Dr. Jahanshad received partial research support from Biogen for work unrelated to the topic of this article. A complete list of author disclosures is in the original article.

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

Women with psoriasis can expect healthy pregnancy outcomes at a rate similar to that of the general population, according to one of the largest studies to examine the issue to date.

However, “pregnancy-specific registries that include a larger number of pregnant women with psoriasis ... are needed to more fully characterize the association between psoriasis and treatment and birth outcomes,” acknowledged first author Alexa B. Kimball, MD, MPH, professor of dermatology, Harvard Medical School, Boston, and colleagues.

The cohort study, published in JAMA Dermatology, used data from the Psoriasis Longitudinal Assessment and Registry (PSOLAR), which “is not a pregnancy specific registry, and medical history is captured only at baseline,” they noted.

Their findings showed pregnancy outcomes such as spontaneous abortion, neonatal problems, and congenital anomalies among women with moderate to severe psoriasis were similar to rates in the general U.S. population, and are “consistent with previously reported data,” they reported. “And pregnancy outcomes for women exposed to biologics were similar to those for women with exposure to nonbiologics.”

The study “provides further reassurance that the biologics appear safe at least related to pregnancy outcomes,” commented Jenny Murase, MD, associate professor of dermatology at the University of California, San Francisco, who was not involved in the study. In an interview, she noted that the study “did not examine any potential immunosuppression of the fetus in the first 6 months of life,” which she described as “the heart of the concern, more than whether or not the psoriasis or the biologic affects the pregnancy itself.”

The study used data from the PSOLAR registry collected from June 20, 2007, to Aug.23, 2019, which included 2,224 women of childbearing age (18-45 years) who were collectively followed up for 12,929 patient-years. Among these women, 220 had 298 pregnancies, with 244 live births (81.9%).

“Birth outcomes among all 244 births included 231 healthy newborns (94.7%), 10 infants with a neonatal problem (4.1%), 1 stillbirth (0.4%), and 2 congenital anomalies (0.8%),” the authors reported.

There were also 41 spontaneous abortions (13.8%), and 13 elective terminations (4.4%). “No elective terminations were known to derive from a congenital anomaly or other medical issue,” they added.

Among the documented pregnancies, 252 occurred in women with exposure to biologic therapy either before or during pregnancy, including 168 (56.4%) during the prenatal period, while 46 pregnancies occurred in women with no exposure to biologic therapy.

Dr. Murase, director of medical consultative dermatology for the Palo Alto Foundation Medical Group in Mountain View, Calif., said that a more detailed comparison of the different psoriasis treatments, as well as the offspring outcomes during the first 6 months of life, might offer some further important insight,.

Infants born after exposure to infliximab “and potentially other anti–tumor necrosis factor–alpha agents during the third trimester may be unable to develop an appropriate immune response to live vaccines,” she and her coauthors cautioned in a letter published in 2011, which referred to a case of an infant with disseminated bacillus Calmette-Guérin infection, whose mother had received infliximab for Crohn’s disease throughout pregnancy.

Dr. Murase pointed out that, in the registry study, exposures to certolizumab, which is pegylated and does not cross the placental barrier, were not separated from other cases. It is important to consider “the cross over late in the second trimester and especially third trimester as the infant is getting the ‘antibody boost’ from the mother as it gets ready to set foot in this world and needs the maternal antibodies to prepare its immune system. If the IgG biologics cross third trimester and immunosuppress the infant ... then I think a medication that does not cross the placental barrier is important to consider.”

The study was sponsored by Janssen Scientific Affairs. Dr. Kimball’s disclosures included serving as a consultant and investigator for companies that included AbbVie, Bristol-Myers Squibb, and Janssen; several other authors also had disclosures related to multiple pharmaceutical companies. Dr. Murase’s disclosures included serving as a consultant for Dermira, UCB Pharma, Sanofi, Ferndale, and Regeneron.

Women with psoriasis can expect healthy pregnancy outcomes at a rate similar to that of the general population, according to one of the largest studies to examine the issue to date.

However, “pregnancy-specific registries that include a larger number of pregnant women with psoriasis ... are needed to more fully characterize the association between psoriasis and treatment and birth outcomes,” acknowledged first author Alexa B. Kimball, MD, MPH, professor of dermatology, Harvard Medical School, Boston, and colleagues.

The cohort study, published in JAMA Dermatology, used data from the Psoriasis Longitudinal Assessment and Registry (PSOLAR), which “is not a pregnancy specific registry, and medical history is captured only at baseline,” they noted.

Their findings showed pregnancy outcomes such as spontaneous abortion, neonatal problems, and congenital anomalies among women with moderate to severe psoriasis were similar to rates in the general U.S. population, and are “consistent with previously reported data,” they reported. “And pregnancy outcomes for women exposed to biologics were similar to those for women with exposure to nonbiologics.”

The study “provides further reassurance that the biologics appear safe at least related to pregnancy outcomes,” commented Jenny Murase, MD, associate professor of dermatology at the University of California, San Francisco, who was not involved in the study. In an interview, she noted that the study “did not examine any potential immunosuppression of the fetus in the first 6 months of life,” which she described as “the heart of the concern, more than whether or not the psoriasis or the biologic affects the pregnancy itself.”

The study used data from the PSOLAR registry collected from June 20, 2007, to Aug.23, 2019, which included 2,224 women of childbearing age (18-45 years) who were collectively followed up for 12,929 patient-years. Among these women, 220 had 298 pregnancies, with 244 live births (81.9%).

“Birth outcomes among all 244 births included 231 healthy newborns (94.7%), 10 infants with a neonatal problem (4.1%), 1 stillbirth (0.4%), and 2 congenital anomalies (0.8%),” the authors reported.

There were also 41 spontaneous abortions (13.8%), and 13 elective terminations (4.4%). “No elective terminations were known to derive from a congenital anomaly or other medical issue,” they added.

Among the documented pregnancies, 252 occurred in women with exposure to biologic therapy either before or during pregnancy, including 168 (56.4%) during the prenatal period, while 46 pregnancies occurred in women with no exposure to biologic therapy.

Dr. Murase, director of medical consultative dermatology for the Palo Alto Foundation Medical Group in Mountain View, Calif., said that a more detailed comparison of the different psoriasis treatments, as well as the offspring outcomes during the first 6 months of life, might offer some further important insight,.

Infants born after exposure to infliximab “and potentially other anti–tumor necrosis factor–alpha agents during the third trimester may be unable to develop an appropriate immune response to live vaccines,” she and her coauthors cautioned in a letter published in 2011, which referred to a case of an infant with disseminated bacillus Calmette-Guérin infection, whose mother had received infliximab for Crohn’s disease throughout pregnancy.

Dr. Murase pointed out that, in the registry study, exposures to certolizumab, which is pegylated and does not cross the placental barrier, were not separated from other cases. It is important to consider “the cross over late in the second trimester and especially third trimester as the infant is getting the ‘antibody boost’ from the mother as it gets ready to set foot in this world and needs the maternal antibodies to prepare its immune system. If the IgG biologics cross third trimester and immunosuppress the infant ... then I think a medication that does not cross the placental barrier is important to consider.”

The study was sponsored by Janssen Scientific Affairs. Dr. Kimball’s disclosures included serving as a consultant and investigator for companies that included AbbVie, Bristol-Myers Squibb, and Janssen; several other authors also had disclosures related to multiple pharmaceutical companies. Dr. Murase’s disclosures included serving as a consultant for Dermira, UCB Pharma, Sanofi, Ferndale, and Regeneron.

Women with psoriasis can expect healthy pregnancy outcomes at a rate similar to that of the general population, according to one of the largest studies to examine the issue to date.

However, “pregnancy-specific registries that include a larger number of pregnant women with psoriasis ... are needed to more fully characterize the association between psoriasis and treatment and birth outcomes,” acknowledged first author Alexa B. Kimball, MD, MPH, professor of dermatology, Harvard Medical School, Boston, and colleagues.

The cohort study, published in JAMA Dermatology, used data from the Psoriasis Longitudinal Assessment and Registry (PSOLAR), which “is not a pregnancy specific registry, and medical history is captured only at baseline,” they noted.

Their findings showed pregnancy outcomes such as spontaneous abortion, neonatal problems, and congenital anomalies among women with moderate to severe psoriasis were similar to rates in the general U.S. population, and are “consistent with previously reported data,” they reported. “And pregnancy outcomes for women exposed to biologics were similar to those for women with exposure to nonbiologics.”

The study “provides further reassurance that the biologics appear safe at least related to pregnancy outcomes,” commented Jenny Murase, MD, associate professor of dermatology at the University of California, San Francisco, who was not involved in the study. In an interview, she noted that the study “did not examine any potential immunosuppression of the fetus in the first 6 months of life,” which she described as “the heart of the concern, more than whether or not the psoriasis or the biologic affects the pregnancy itself.”

The study used data from the PSOLAR registry collected from June 20, 2007, to Aug.23, 2019, which included 2,224 women of childbearing age (18-45 years) who were collectively followed up for 12,929 patient-years. Among these women, 220 had 298 pregnancies, with 244 live births (81.9%).

“Birth outcomes among all 244 births included 231 healthy newborns (94.7%), 10 infants with a neonatal problem (4.1%), 1 stillbirth (0.4%), and 2 congenital anomalies (0.8%),” the authors reported.

There were also 41 spontaneous abortions (13.8%), and 13 elective terminations (4.4%). “No elective terminations were known to derive from a congenital anomaly or other medical issue,” they added.

Among the documented pregnancies, 252 occurred in women with exposure to biologic therapy either before or during pregnancy, including 168 (56.4%) during the prenatal period, while 46 pregnancies occurred in women with no exposure to biologic therapy.

Dr. Murase, director of medical consultative dermatology for the Palo Alto Foundation Medical Group in Mountain View, Calif., said that a more detailed comparison of the different psoriasis treatments, as well as the offspring outcomes during the first 6 months of life, might offer some further important insight,.

Infants born after exposure to infliximab “and potentially other anti–tumor necrosis factor–alpha agents during the third trimester may be unable to develop an appropriate immune response to live vaccines,” she and her coauthors cautioned in a letter published in 2011, which referred to a case of an infant with disseminated bacillus Calmette-Guérin infection, whose mother had received infliximab for Crohn’s disease throughout pregnancy.

Dr. Murase pointed out that, in the registry study, exposures to certolizumab, which is pegylated and does not cross the placental barrier, were not separated from other cases. It is important to consider “the cross over late in the second trimester and especially third trimester as the infant is getting the ‘antibody boost’ from the mother as it gets ready to set foot in this world and needs the maternal antibodies to prepare its immune system. If the IgG biologics cross third trimester and immunosuppress the infant ... then I think a medication that does not cross the placental barrier is important to consider.”

The study was sponsored by Janssen Scientific Affairs. Dr. Kimball’s disclosures included serving as a consultant and investigator for companies that included AbbVie, Bristol-Myers Squibb, and Janssen; several other authors also had disclosures related to multiple pharmaceutical companies. Dr. Murase’s disclosures included serving as a consultant for Dermira, UCB Pharma, Sanofi, Ferndale, and Regeneron.

Case

Max was a 17-year-old boy and avid video gamer who, predating COVID-19, was within a major depressive episode and continued to meet criteria through the duration of COVID-19 quarantine. He lives with his mother, who is a single mom and is working hard in a variety of jobs through the pandemic. Max had little motivation to engage in sports or other activities, and despite doing well enough in school, he spent much of his days escaping into video games and social media, where his friends communicated and bonded the most. He has had very little response to complete trials of two different selective serotonin reuptake inhibitors (SSRIs), and the off-label attempts at a serotonin-norepinephrine reuptake inhibitor and bupropion augmentation of an SSRI, as extrapolated by his pediatrician from adult data on treatment-resistant depression. He had ongoing supportive psychotherapy and his mother and pediatrician were wary of changing that relationship, as they were just happy he would engage at all. His shy nature made him very wary of attending any programs or groups. He had no other diagnosis including anxiety, substance abuse disorder, or learning disorder.

Case discussion

As a child and adolescent psychiatrist embedded in primary care practices, I (like you) am seeing more and more parents, children, and families struggling with depression through the course of this unprecedented and challenging year.

Max presented to me with his mother at the request of his primary care physician because within the course of many medication trials, it had been over 6 months of persistent symptoms without an end in sight for him, his family, or his primary care provider (PCP).

His diagnosis was treatment-resistant depression and his PCP was grasping at adult strategies to manage this all with additional psychopharmacology. As a consulting child-and-adolescent psychiatrist in primary care, how could I help the PCP? I too worry if there is anything that I can do to shift depression once standard treatments fail, and when the idea of engaging in behavioral activation or other pro-health activities is just too much for a depressed adolescent to bear. I weigh that with what is known about the evidence, and the good data driving us beyond medication solutions. I often find that it can be helpful to reiterate the following points to providers and families.
 

First, what to know about depression in kids

Depression looks different at different ages in children. In school-aged children, it’s widely known that irritability or psychosomatic symptoms (frequent headaches and stomach aches) can be the first preverbal signs of an emerging anxiety and depressive disorder in children. In adolescents, one would maybe expect more typical melancholic adult-like symptoms of depression; however, there is mounting evidence that adolescents actually present with more classically “atypical symptoms” of depression (low motivation, weight gain, escapism to sleep or video games, as with Max) with less persistence across setting (home, work, school) compared with adults (“Diagnosing Depression in Children and Adolescents” by Glen R. Elliott, PhD, MD, from The Carlat Child Psychiatry Report, November 2015, Antidepressant Use in Children).In addition, major life stressors (the breakup of a romantic relationship, failing a class, bullying) can be perceived as more permanent, and suicidal thinking can be acute and lethal in these contexts. With Max, it was accepted by all who were supporting him that he was struggling with depression, which is the first step in managing this well.

The idea of the designated patient

Often left out in a discussion of pediatric patients is the family. As a designated patient, much of our focus is on improving the symptoms of the patient in front of us. Parents direct their gaze at the child as the one with the condition who needs support. First following identification of depression, I find that a reframe of a diagnosis can be useful. Family systems theory approaches a child with a depression diagnosis, and says, that if one family member changes, even in a small way, a family as a system is forced to change. With a sense of an external locus of control, we often are left with a patient and parent feeling stuck. To provide a reorientation to the parents, ask how they are feeling. Can they get treatment for depression knowing the biology of the condition or consider making behavioral changes of their own and as a family? Can they consider family psychotherapy so they can cope better and break some cycles of maladaptive engagement shared across a family? These kinds of reorientations can be useful to shift the idea of treatment from the designated patient (the child) and medication options (limited data for kids who aren’t responding to them) to a family approach. Making the depression management strategy a family affair can help the entire family shift from seeing the only option as medications or interventions exclusively directed at a child. The Vermont Center for Children, Youth, and Families at the University of Vermont Medical Center has many pioneering developments in addressing family-based approaches to mental health concerns in the pediatric population, and can serve as a source of inspiration for this shift in discussing depression.

Practical strategies for the pediatrician

Medications can be useful for treating child and adolescent depression, but there is also strong evidence for psychotherapy, working with the child’s school and family, and different forms of behavioral activation (exercise, mindfulness, yoga, and other positive activities). Medications, if one is looking at standard of care treatment and Food and Drug Administration approval exclusively, is limited in scope and should not be the only intervention considered, as described in the case above.

In “The Use of Medication in Treating Childhood and Adolescent Depression: Information for Patients and Families,” which is a practical guide prepared by the American Psychiatric Association and the American Academy of Child and Adolescent Psychiatry, it is noted that Prozac and Lexapro are approved medications, as follows:

• Antidepressant medications can be effective in relieving the symptoms of depression for some children and adolescents. One antidepressant – fluoxetine, or Prozac – a medicine in the category of SSRIs, has been approved by the FDA for treating depression in children 8 years of age and older. Escitalopram, or Lexapro, has also been approved by the FDA for treating adolescents 12 years of age and older.
• About “60 percent of children and adolescents will respond to initial treatment with medication,” which leaves many children needing further interventions. “Of those who don’t [respond], a significant number may respond to another medication but also may respond to the addition of a form of psychotherapy called cognitive behavioral therapy (CBT).”

It is common, as in the case above, that a connection with a therapist or support is valued over the specific modality even if it’s not showing improvement or outcomes. It is important to consider CBT as a form of evidence-based treatment for children with depression and to cite the famous “Treatment for Adolescents with Depression Study (TADS)” funded by the National Institute of Mental Health, published in 2004, that shows the following findings: “After 12 weeks of treatment, 71 percent of the patients who received the combination of medication and CBT were much improved.” In looking at the group that does not improve with medications alone, adolescents in particular can have more gains with the addition of CBT.
 

Tracking progress, little by little

Often we reflexively ask parents of depressed children: Are they better? And we ask the child: How do you feel? It can be difficult for parents to reflect on that, or see progress or gains from appointment to appointment. I suggest trying to use structured measures and tools to frame a discussion with progress on medication and treatment such as what is available at the Mood Treatment Center website.I also suggest apps such as Mood Kit,which is for mood tracking with some CBT exercises in addition to behavioral activation strategies for children and parents. It can be useful to have families take some ownership of tracking their moods and what may be playing into them. In particular with the pandemic, we can reflect on how much isolation or socialization, activities, sleep, eating habits, and exercise can affect us and make corresponding behavioral changes as a family to improve our own coping. Depression itself can be like glasses clouding one’s vision in gray, and that can also cloud one’s review of progress. When we hear comments such as “nothing gets better” from a child or parent, it may be helpful to try to track any contributing factors to a persistent low mood and acknowledge any slow and steady progress.

In summary, we can strive as providers to maximize our approach to depression in children and adolescents beyond the limited FDA-approved medications, or extrapolating adult data to children. If we emphasize the evidence-based practice of CBT and other interventions in addition to encouraging a tracking and review of outcomes measures with parents and families, we can empower them to make meaningful change in both perspectives and behaviors that can perpetuate depressive states.
 

Dr. Pawlowski is an adult, adolescent, and child psychiatrist at the University of Vermont Medical Center and assistant professor of psychiatry at the Larner College of Medicine at UVM in Burlington.

Case

Max was a 17-year-old boy and avid video gamer who, predating COVID-19, was within a major depressive episode and continued to meet criteria through the duration of COVID-19 quarantine. He lives with his mother, who is a single mom and is working hard in a variety of jobs through the pandemic. Max had little motivation to engage in sports or other activities, and despite doing well enough in school, he spent much of his days escaping into video games and social media, where his friends communicated and bonded the most. He has had very little response to complete trials of two different selective serotonin reuptake inhibitors (SSRIs), and the off-label attempts at a serotonin-norepinephrine reuptake inhibitor and bupropion augmentation of an SSRI, as extrapolated by his pediatrician from adult data on treatment-resistant depression. He had ongoing supportive psychotherapy and his mother and pediatrician were wary of changing that relationship, as they were just happy he would engage at all. His shy nature made him very wary of attending any programs or groups. He had no other diagnosis including anxiety, substance abuse disorder, or learning disorder.

Case discussion

As a child and adolescent psychiatrist embedded in primary care practices, I (like you) am seeing more and more parents, children, and families struggling with depression through the course of this unprecedented and challenging year.

Max presented to me with his mother at the request of his primary care physician because within the course of many medication trials, it had been over 6 months of persistent symptoms without an end in sight for him, his family, or his primary care provider (PCP).

His diagnosis was treatment-resistant depression and his PCP was grasping at adult strategies to manage this all with additional psychopharmacology. As a consulting child-and-adolescent psychiatrist in primary care, how could I help the PCP? I too worry if there is anything that I can do to shift depression once standard treatments fail, and when the idea of engaging in behavioral activation or other pro-health activities is just too much for a depressed adolescent to bear. I weigh that with what is known about the evidence, and the good data driving us beyond medication solutions. I often find that it can be helpful to reiterate the following points to providers and families.
 

First, what to know about depression in kids

Depression looks different at different ages in children. In school-aged children, it’s widely known that irritability or psychosomatic symptoms (frequent headaches and stomach aches) can be the first preverbal signs of an emerging anxiety and depressive disorder in children. In adolescents, one would maybe expect more typical melancholic adult-like symptoms of depression; however, there is mounting evidence that adolescents actually present with more classically “atypical symptoms” of depression (low motivation, weight gain, escapism to sleep or video games, as with Max) with less persistence across setting (home, work, school) compared with adults (“Diagnosing Depression in Children and Adolescents” by Glen R. Elliott, PhD, MD, from The Carlat Child Psychiatry Report, November 2015, Antidepressant Use in Children).In addition, major life stressors (the breakup of a romantic relationship, failing a class, bullying) can be perceived as more permanent, and suicidal thinking can be acute and lethal in these contexts. With Max, it was accepted by all who were supporting him that he was struggling with depression, which is the first step in managing this well.

The idea of the designated patient

Often left out in a discussion of pediatric patients is the family. As a designated patient, much of our focus is on improving the symptoms of the patient in front of us. Parents direct their gaze at the child as the one with the condition who needs support. First following identification of depression, I find that a reframe of a diagnosis can be useful. Family systems theory approaches a child with a depression diagnosis, and says, that if one family member changes, even in a small way, a family as a system is forced to change. With a sense of an external locus of control, we often are left with a patient and parent feeling stuck. To provide a reorientation to the parents, ask how they are feeling. Can they get treatment for depression knowing the biology of the condition or consider making behavioral changes of their own and as a family? Can they consider family psychotherapy so they can cope better and break some cycles of maladaptive engagement shared across a family? These kinds of reorientations can be useful to shift the idea of treatment from the designated patient (the child) and medication options (limited data for kids who aren’t responding to them) to a family approach. Making the depression management strategy a family affair can help the entire family shift from seeing the only option as medications or interventions exclusively directed at a child. The Vermont Center for Children, Youth, and Families at the University of Vermont Medical Center has many pioneering developments in addressing family-based approaches to mental health concerns in the pediatric population, and can serve as a source of inspiration for this shift in discussing depression.

Practical strategies for the pediatrician

Medications can be useful for treating child and adolescent depression, but there is also strong evidence for psychotherapy, working with the child’s school and family, and different forms of behavioral activation (exercise, mindfulness, yoga, and other positive activities). Medications, if one is looking at standard of care treatment and Food and Drug Administration approval exclusively, is limited in scope and should not be the only intervention considered, as described in the case above.

In “The Use of Medication in Treating Childhood and Adolescent Depression: Information for Patients and Families,” which is a practical guide prepared by the American Psychiatric Association and the American Academy of Child and Adolescent Psychiatry, it is noted that Prozac and Lexapro are approved medications, as follows:

• Antidepressant medications can be effective in relieving the symptoms of depression for some children and adolescents. One antidepressant – fluoxetine, or Prozac – a medicine in the category of SSRIs, has been approved by the FDA for treating depression in children 8 years of age and older. Escitalopram, or Lexapro, has also been approved by the FDA for treating adolescents 12 years of age and older.
• About “60 percent of children and adolescents will respond to initial treatment with medication,” which leaves many children needing further interventions. “Of those who don’t [respond], a significant number may respond to another medication but also may respond to the addition of a form of psychotherapy called cognitive behavioral therapy (CBT).”

It is common, as in the case above, that a connection with a therapist or support is valued over the specific modality even if it’s not showing improvement or outcomes. It is important to consider CBT as a form of evidence-based treatment for children with depression and to cite the famous “Treatment for Adolescents with Depression Study (TADS)” funded by the National Institute of Mental Health, published in 2004, that shows the following findings: “After 12 weeks of treatment, 71 percent of the patients who received the combination of medication and CBT were much improved.” In looking at the group that does not improve with medications alone, adolescents in particular can have more gains with the addition of CBT.
 

Tracking progress, little by little

Often we reflexively ask parents of depressed children: Are they better? And we ask the child: How do you feel? It can be difficult for parents to reflect on that, or see progress or gains from appointment to appointment. I suggest trying to use structured measures and tools to frame a discussion with progress on medication and treatment such as what is available at the Mood Treatment Center website.I also suggest apps such as Mood Kit,which is for mood tracking with some CBT exercises in addition to behavioral activation strategies for children and parents. It can be useful to have families take some ownership of tracking their moods and what may be playing into them. In particular with the pandemic, we can reflect on how much isolation or socialization, activities, sleep, eating habits, and exercise can affect us and make corresponding behavioral changes as a family to improve our own coping. Depression itself can be like glasses clouding one’s vision in gray, and that can also cloud one’s review of progress. When we hear comments such as “nothing gets better” from a child or parent, it may be helpful to try to track any contributing factors to a persistent low mood and acknowledge any slow and steady progress.

In summary, we can strive as providers to maximize our approach to depression in children and adolescents beyond the limited FDA-approved medications, or extrapolating adult data to children. If we emphasize the evidence-based practice of CBT and other interventions in addition to encouraging a tracking and review of outcomes measures with parents and families, we can empower them to make meaningful change in both perspectives and behaviors that can perpetuate depressive states.
 

Dr. Pawlowski is an adult, adolescent, and child psychiatrist at the University of Vermont Medical Center and assistant professor of psychiatry at the Larner College of Medicine at UVM in Burlington.

Case

Max was a 17-year-old boy and avid video gamer who, predating COVID-19, was within a major depressive episode and continued to meet criteria through the duration of COVID-19 quarantine. He lives with his mother, who is a single mom and is working hard in a variety of jobs through the pandemic. Max had little motivation to engage in sports or other activities, and despite doing well enough in school, he spent much of his days escaping into video games and social media, where his friends communicated and bonded the most. He has had very little response to complete trials of two different selective serotonin reuptake inhibitors (SSRIs), and the off-label attempts at a serotonin-norepinephrine reuptake inhibitor and bupropion augmentation of an SSRI, as extrapolated by his pediatrician from adult data on treatment-resistant depression. He had ongoing supportive psychotherapy and his mother and pediatrician were wary of changing that relationship, as they were just happy he would engage at all. His shy nature made him very wary of attending any programs or groups. He had no other diagnosis including anxiety, substance abuse disorder, or learning disorder.

Case discussion

As a child and adolescent psychiatrist embedded in primary care practices, I (like you) am seeing more and more parents, children, and families struggling with depression through the course of this unprecedented and challenging year.

Max presented to me with his mother at the request of his primary care physician because within the course of many medication trials, it had been over 6 months of persistent symptoms without an end in sight for him, his family, or his primary care provider (PCP).

His diagnosis was treatment-resistant depression and his PCP was grasping at adult strategies to manage this all with additional psychopharmacology. As a consulting child-and-adolescent psychiatrist in primary care, how could I help the PCP? I too worry if there is anything that I can do to shift depression once standard treatments fail, and when the idea of engaging in behavioral activation or other pro-health activities is just too much for a depressed adolescent to bear. I weigh that with what is known about the evidence, and the good data driving us beyond medication solutions. I often find that it can be helpful to reiterate the following points to providers and families.
 

First, what to know about depression in kids

Depression looks different at different ages in children. In school-aged children, it’s widely known that irritability or psychosomatic symptoms (frequent headaches and stomach aches) can be the first preverbal signs of an emerging anxiety and depressive disorder in children. In adolescents, one would maybe expect more typical melancholic adult-like symptoms of depression; however, there is mounting evidence that adolescents actually present with more classically “atypical symptoms” of depression (low motivation, weight gain, escapism to sleep or video games, as with Max) with less persistence across setting (home, work, school) compared with adults (“Diagnosing Depression in Children and Adolescents” by Glen R. Elliott, PhD, MD, from The Carlat Child Psychiatry Report, November 2015, Antidepressant Use in Children).In addition, major life stressors (the breakup of a romantic relationship, failing a class, bullying) can be perceived as more permanent, and suicidal thinking can be acute and lethal in these contexts. With Max, it was accepted by all who were supporting him that he was struggling with depression, which is the first step in managing this well.

The idea of the designated patient

Often left out in a discussion of pediatric patients is the family. As a designated patient, much of our focus is on improving the symptoms of the patient in front of us. Parents direct their gaze at the child as the one with the condition who needs support. First following identification of depression, I find that a reframe of a diagnosis can be useful. Family systems theory approaches a child with a depression diagnosis, and says, that if one family member changes, even in a small way, a family as a system is forced to change. With a sense of an external locus of control, we often are left with a patient and parent feeling stuck. To provide a reorientation to the parents, ask how they are feeling. Can they get treatment for depression knowing the biology of the condition or consider making behavioral changes of their own and as a family? Can they consider family psychotherapy so they can cope better and break some cycles of maladaptive engagement shared across a family? These kinds of reorientations can be useful to shift the idea of treatment from the designated patient (the child) and medication options (limited data for kids who aren’t responding to them) to a family approach. Making the depression management strategy a family affair can help the entire family shift from seeing the only option as medications or interventions exclusively directed at a child. The Vermont Center for Children, Youth, and Families at the University of Vermont Medical Center has many pioneering developments in addressing family-based approaches to mental health concerns in the pediatric population, and can serve as a source of inspiration for this shift in discussing depression.

Practical strategies for the pediatrician

Medications can be useful for treating child and adolescent depression, but there is also strong evidence for psychotherapy, working with the child’s school and family, and different forms of behavioral activation (exercise, mindfulness, yoga, and other positive activities). Medications, if one is looking at standard of care treatment and Food and Drug Administration approval exclusively, is limited in scope and should not be the only intervention considered, as described in the case above.

In “The Use of Medication in Treating Childhood and Adolescent Depression: Information for Patients and Families,” which is a practical guide prepared by the American Psychiatric Association and the American Academy of Child and Adolescent Psychiatry, it is noted that Prozac and Lexapro are approved medications, as follows:

• Antidepressant medications can be effective in relieving the symptoms of depression for some children and adolescents. One antidepressant – fluoxetine, or Prozac – a medicine in the category of SSRIs, has been approved by the FDA for treating depression in children 8 years of age and older. Escitalopram, or Lexapro, has also been approved by the FDA for treating adolescents 12 years of age and older.
• About “60 percent of children and adolescents will respond to initial treatment with medication,” which leaves many children needing further interventions. “Of those who don’t [respond], a significant number may respond to another medication but also may respond to the addition of a form of psychotherapy called cognitive behavioral therapy (CBT).”

It is common, as in the case above, that a connection with a therapist or support is valued over the specific modality even if it’s not showing improvement or outcomes. It is important to consider CBT as a form of evidence-based treatment for children with depression and to cite the famous “Treatment for Adolescents with Depression Study (TADS)” funded by the National Institute of Mental Health, published in 2004, that shows the following findings: “After 12 weeks of treatment, 71 percent of the patients who received the combination of medication and CBT were much improved.” In looking at the group that does not improve with medications alone, adolescents in particular can have more gains with the addition of CBT.
 

Tracking progress, little by little

Often we reflexively ask parents of depressed children: Are they better? And we ask the child: How do you feel? It can be difficult for parents to reflect on that, or see progress or gains from appointment to appointment. I suggest trying to use structured measures and tools to frame a discussion with progress on medication and treatment such as what is available at the Mood Treatment Center website.I also suggest apps such as Mood Kit,which is for mood tracking with some CBT exercises in addition to behavioral activation strategies for children and parents. It can be useful to have families take some ownership of tracking their moods and what may be playing into them. In particular with the pandemic, we can reflect on how much isolation or socialization, activities, sleep, eating habits, and exercise can affect us and make corresponding behavioral changes as a family to improve our own coping. Depression itself can be like glasses clouding one’s vision in gray, and that can also cloud one’s review of progress. When we hear comments such as “nothing gets better” from a child or parent, it may be helpful to try to track any contributing factors to a persistent low mood and acknowledge any slow and steady progress.

In summary, we can strive as providers to maximize our approach to depression in children and adolescents beyond the limited FDA-approved medications, or extrapolating adult data to children. If we emphasize the evidence-based practice of CBT and other interventions in addition to encouraging a tracking and review of outcomes measures with parents and families, we can empower them to make meaningful change in both perspectives and behaviors that can perpetuate depressive states.
 

Dr. Pawlowski is an adult, adolescent, and child psychiatrist at the University of Vermont Medical Center and assistant professor of psychiatry at the Larner College of Medicine at UVM in Burlington.

The phase 3a STEP 1 trial that investigated the use of semaglutide (Novo Nordisk), a glucagonlike peptide–1 (GLP-1) agonist, for weight loss is aptly named, some say.

“In sum, we have a long way to go to control the obesity epidemic ... but on the face of it, the STEP 1 trial (like its name) is a good beginning,” wrote coeditorialists Julie R. Ingelfinger, MD, from Harvard Medical School, Boston, and a deputy editor of the New England Journal of Medicine, and Clifford J. Rosen, MD, from Tufts University School of Medicine, also in Boston.

The trial findings by John P.H. Wilding, DM, University of Liverpool (England), and colleagues and an accompanying editorial were published online Feb. 10, 2021, in the New England Journal of Medicine.

“The results are encouraging, with significantly more patients in the semaglutide group having clinically important weight loss,” Dr. Ingelfinger and Dr. Rosen stressed.

However, they also cautioned that “despite the positive results of this trial, the present study has some important limitations” and “there are concerns, including adverse events (mostly gastrointestinal – nausea, sometimes vomiting, and diarrhea) related primarily to the class of the agent.”

Two U.K. experts drew similar takeaways, speaking to the U.K. Science Media Centre.

“This was a well-designed study with unequivocal findings,” which showed that semaglutide “is indeed likely to be a game-changer in the fight against obesity,” according to Baptiste Leurent, PhD, London School of Hygiene and Tropical Medicine.

However, if the drug is approved at this dose for this use, patients would need close monitoring for gastrointestinal disorders, and “we also need to better understand what is happening once the treatment is stopped, and whether it could be taken for a shorter period of time.”

Sir Stephen O’Rahilly, MD, MRC Metabolic Diseases Unit, University of Cambridge (England), pointed out that “GLP-1 is made by cells in the intestine and levels increase in the blood after a meal, providing some of the signal to the brain that tells us we are ‘full,’ ” so GLP-1 agonists have been studied as appetite suppressants, in addition to their approved use to treat type 2 diabetes.

Only about 4.5% of participants in STEP 1 stopped taking semaglutide because of gastrointestinal issues, he noted, although more participants in that group reported problems with gallstones, which can follow rapid weight loss.

And “unlike some previous appetite suppressant drugs which caused significant psychological and psychiatric side effects, there is no evidence that semaglutide has any adverse effects of that nature,” Dr. O’Rahilly noted.

In sum, he said, “this is the start of a new era for obesity drug development with the future direction being to achieve levels of weight loss comparable to semaglutide, while having fewer side effects.”
 

‘Pressing need’ to address obesity; semaglutide filed for obesity

There is a “pressing need” to address the worldwide increase in obesity and weight-related coexisting conditions, Dr. Ingelfinger and Dr. Rosen noted.

Sustained long-term weight loss with diet and exercise is challenging; behavioral weight-loss strategies “fail more often than not,” bariatric surgery is invasive and often followed by eventual weight regain, they wrote.

In addition, said Dr. Wilding and colleagues, the “use of available [weight-loss] medications remains limited by modest efficacy, safety concerns, and cost.”

Subcutaneous semaglutide, approved for treating type 2 diabetes (as Ozempic) in adults at doses of up to 1 mg/week, induced weight loss at higher doses. The current study is part of the global Semaglutide Treatment Effect in People With Obesity program of four trials (STEP 1, 2, 3, and 4) that aimed to test the safety and efficacy of subcutaneous semaglutide 2.4 mg/week for weight loss.

Topline results from STEP 1 were presented June 4, 2020.

And as reported earlier, results from STEP 3 – a 68-week trial of semaglutide versus placebo in 611 participants who all received very intensive diet and exercise counseling – were presented at the virtual ObesityWeek 2020 meeting.

The four trials of semaglutide for weight loss have been completed and the data were submitted to the Food and Drug Administration on Dec. 4, 2020 (with a decision expected within 6 months) and to the European Medicines Agency on Dec. 18, 2020.
 

Most patients had 5% weight loss with semaglutide

The STEP 1 trial enrolled 1,961 adults with a body mass index (BMI) of at least 30 kg/m² or at least 27 with at least one weight-related coexisting condition, but without type 2 diabetes, at 129 sites in 16 countries in Asia, Europe, North America, and South America.

Participants were a mean age of 47 and three-quarters were women. Most participants were White (76%), followed by Asian (13%), Black or African American (6%), or other (5%).

On average, they had a BMI of 38 and weighed 105 kg. Three-quarters had one or more coexisting conditions.

Participants were randomized to receive semaglutide (1,306 patients) or placebo (655 patients), added to lifestyle intervention.

Everyone received 17 monthly individual counseling sessions during which they learned about adhering to a diet with a 500-calorie/day deficit, were encouraged to build up to walking 150 minutes each week, and recorded their daily diet and exercise (in a diary or using an app).

Semaglutide was administered with a prefilled pen injector at a dose of 0.25 mg/week for the first 4 weeks, escalated to 2.4 mg/week by week 16 (or lower if the patient had unacceptable side effects).

At 68 weeks, participants in the semaglutide versus placebo group had greater mean weight loss (14.9% vs. 2.4%, or 15.3 kg vs. 2.6 kg).

Participants in the semaglutide versus placebo group were much more likely to have lost at least 5% of their initial weight (86% vs. 31.5%) or at least 10% of their initial weight (69.1% vs. 12.0%), or at least 15% of their initial weight (50.5% vs. 4.9%; P < .001 for all three comparisons).

About 80% of participants adhered to the study treatment. A third of participants in the semaglutide group who completed the study lost at least 20% of their initial weight, which approaches the 20%-30% reported weight loss 1-3 years after sleeve gastrectomy, the researchers noted.

Participants in the semaglutide group also had greater improvements in waist circumference and levels of hemoglobin A1c, C-reactive protein (a marker of inflammation), and fasting lipids, as well as in physical function scores on SF-36 and IWQOL-Lite-CT questionnaires.

In their editorial, Dr. Ingelfinger and Dr. Rosen noted that “daily oral semaglutide [already approved in 7-mg and 14-mg doses for the treatment of type 2 diabetes as Rybelsus] might be more appealing to many people,” as a weight-loss medication than a once-weekly subcutaneous dose. Semaglutide is the first GLP-1 agonist available as an oral agent.

The ongoing Semaglutide Effects on Heart Disease and Stroke in Patients With Overweight or Obesity (SELECT) trial (with expected completion in 2023) will shed light on cardiovascular outcomes after 2.5-5 years.
 

GI disorders and ‘important limitations’

More participants in the semaglutide than the placebo group reported gastrointestinal disorders (typically nausea, diarrhea, vomiting, and constipation; 74.2% vs. 47.9%), which were mostly transient and mild to moderate in severity, but also led to more treatment discontinuation (7.0% vs. 3.1%).

More patients in the semaglutide versus placebo group had a gall bladder–related disorder (2.6% vs. 1.2%, mostly cholelithiasis) and mild acute pancreatitis (3 vs. 0 participants), but there were no between-group differences in neoplasms.

Dr. Wilding and colleagues acknowledge the limitations of the study, including the fact that it enrolled mainly women, mainly non-White participants, was relatively short, and excluded patients with type 2 diabetes.

Mean placebo-corrected weight loss with 2.4 mg/weekly subcutaneous semaglutide was greater than with 3.0 mg once-daily subcutaneous liraglutide (Saxenda, Novo Nordisk) – the only GLP-1 agonist approved for weight management – in the 56-week SCALE trial (12.4% vs. 4.5%); however, the two studies had different populations.

The study was supported by Novo Nordisk. Dr. Ingelfinger is a deputy editor and Dr. Rosen is an associate editor of the New England Journal of Medicine. Dr. Ingelfinger, Dr. Rosen, and Dr. Leurent have reported no relevant financial relationships. Dr. O’Rahilly has a current research collaboration with Novo Nordisk scientists in an unrelated area and has been a consultant for the company.

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

The phase 3a STEP 1 trial that investigated the use of semaglutide (Novo Nordisk), a glucagonlike peptide–1 (GLP-1) agonist, for weight loss is aptly named, some say.

“In sum, we have a long way to go to control the obesity epidemic ... but on the face of it, the STEP 1 trial (like its name) is a good beginning,” wrote coeditorialists Julie R. Ingelfinger, MD, from Harvard Medical School, Boston, and a deputy editor of the New England Journal of Medicine, and Clifford J. Rosen, MD, from Tufts University School of Medicine, also in Boston.

The trial findings by John P.H. Wilding, DM, University of Liverpool (England), and colleagues and an accompanying editorial were published online Feb. 10, 2021, in the New England Journal of Medicine.

“The results are encouraging, with significantly more patients in the semaglutide group having clinically important weight loss,” Dr. Ingelfinger and Dr. Rosen stressed.

However, they also cautioned that “despite the positive results of this trial, the present study has some important limitations” and “there are concerns, including adverse events (mostly gastrointestinal – nausea, sometimes vomiting, and diarrhea) related primarily to the class of the agent.”

Two U.K. experts drew similar takeaways, speaking to the U.K. Science Media Centre.

“This was a well-designed study with unequivocal findings,” which showed that semaglutide “is indeed likely to be a game-changer in the fight against obesity,” according to Baptiste Leurent, PhD, London School of Hygiene and Tropical Medicine.

However, if the drug is approved at this dose for this use, patients would need close monitoring for gastrointestinal disorders, and “we also need to better understand what is happening once the treatment is stopped, and whether it could be taken for a shorter period of time.”

Sir Stephen O’Rahilly, MD, MRC Metabolic Diseases Unit, University of Cambridge (England), pointed out that “GLP-1 is made by cells in the intestine and levels increase in the blood after a meal, providing some of the signal to the brain that tells us we are ‘full,’ ” so GLP-1 agonists have been studied as appetite suppressants, in addition to their approved use to treat type 2 diabetes.

Only about 4.5% of participants in STEP 1 stopped taking semaglutide because of gastrointestinal issues, he noted, although more participants in that group reported problems with gallstones, which can follow rapid weight loss.

And “unlike some previous appetite suppressant drugs which caused significant psychological and psychiatric side effects, there is no evidence that semaglutide has any adverse effects of that nature,” Dr. O’Rahilly noted.

In sum, he said, “this is the start of a new era for obesity drug development with the future direction being to achieve levels of weight loss comparable to semaglutide, while having fewer side effects.”
 

‘Pressing need’ to address obesity; semaglutide filed for obesity

There is a “pressing need” to address the worldwide increase in obesity and weight-related coexisting conditions, Dr. Ingelfinger and Dr. Rosen noted.

Sustained long-term weight loss with diet and exercise is challenging; behavioral weight-loss strategies “fail more often than not,” bariatric surgery is invasive and often followed by eventual weight regain, they wrote.

In addition, said Dr. Wilding and colleagues, the “use of available [weight-loss] medications remains limited by modest efficacy, safety concerns, and cost.”

Subcutaneous semaglutide, approved for treating type 2 diabetes (as Ozempic) in adults at doses of up to 1 mg/week, induced weight loss at higher doses. The current study is part of the global Semaglutide Treatment Effect in People With Obesity program of four trials (STEP 1, 2, 3, and 4) that aimed to test the safety and efficacy of subcutaneous semaglutide 2.4 mg/week for weight loss.

Topline results from STEP 1 were presented June 4, 2020.

And as reported earlier, results from STEP 3 – a 68-week trial of semaglutide versus placebo in 611 participants who all received very intensive diet and exercise counseling – were presented at the virtual ObesityWeek 2020 meeting.

The four trials of semaglutide for weight loss have been completed and the data were submitted to the Food and Drug Administration on Dec. 4, 2020 (with a decision expected within 6 months) and to the European Medicines Agency on Dec. 18, 2020.
 

Most patients had 5% weight loss with semaglutide

The STEP 1 trial enrolled 1,961 adults with a body mass index (BMI) of at least 30 kg/m² or at least 27 with at least one weight-related coexisting condition, but without type 2 diabetes, at 129 sites in 16 countries in Asia, Europe, North America, and South America.

Participants were a mean age of 47 and three-quarters were women. Most participants were White (76%), followed by Asian (13%), Black or African American (6%), or other (5%).

On average, they had a BMI of 38 and weighed 105 kg. Three-quarters had one or more coexisting conditions.

Participants were randomized to receive semaglutide (1,306 patients) or placebo (655 patients), added to lifestyle intervention.

Everyone received 17 monthly individual counseling sessions during which they learned about adhering to a diet with a 500-calorie/day deficit, were encouraged to build up to walking 150 minutes each week, and recorded their daily diet and exercise (in a diary or using an app).

Semaglutide was administered with a prefilled pen injector at a dose of 0.25 mg/week for the first 4 weeks, escalated to 2.4 mg/week by week 16 (or lower if the patient had unacceptable side effects).

At 68 weeks, participants in the semaglutide versus placebo group had greater mean weight loss (14.9% vs. 2.4%, or 15.3 kg vs. 2.6 kg).

Participants in the semaglutide versus placebo group were much more likely to have lost at least 5% of their initial weight (86% vs. 31.5%) or at least 10% of their initial weight (69.1% vs. 12.0%), or at least 15% of their initial weight (50.5% vs. 4.9%; P < .001 for all three comparisons).

About 80% of participants adhered to the study treatment. A third of participants in the semaglutide group who completed the study lost at least 20% of their initial weight, which approaches the 20%-30% reported weight loss 1-3 years after sleeve gastrectomy, the researchers noted.

Participants in the semaglutide group also had greater improvements in waist circumference and levels of hemoglobin A1c, C-reactive protein (a marker of inflammation), and fasting lipids, as well as in physical function scores on SF-36 and IWQOL-Lite-CT questionnaires.

In their editorial, Dr. Ingelfinger and Dr. Rosen noted that “daily oral semaglutide [already approved in 7-mg and 14-mg doses for the treatment of type 2 diabetes as Rybelsus] might be more appealing to many people,” as a weight-loss medication than a once-weekly subcutaneous dose. Semaglutide is the first GLP-1 agonist available as an oral agent.

The ongoing Semaglutide Effects on Heart Disease and Stroke in Patients With Overweight or Obesity (SELECT) trial (with expected completion in 2023) will shed light on cardiovascular outcomes after 2.5-5 years.
 

GI disorders and ‘important limitations’

More participants in the semaglutide than the placebo group reported gastrointestinal disorders (typically nausea, diarrhea, vomiting, and constipation; 74.2% vs. 47.9%), which were mostly transient and mild to moderate in severity, but also led to more treatment discontinuation (7.0% vs. 3.1%).

More patients in the semaglutide versus placebo group had a gall bladder–related disorder (2.6% vs. 1.2%, mostly cholelithiasis) and mild acute pancreatitis (3 vs. 0 participants), but there were no between-group differences in neoplasms.

Dr. Wilding and colleagues acknowledge the limitations of the study, including the fact that it enrolled mainly women, mainly non-White participants, was relatively short, and excluded patients with type 2 diabetes.

Mean placebo-corrected weight loss with 2.4 mg/weekly subcutaneous semaglutide was greater than with 3.0 mg once-daily subcutaneous liraglutide (Saxenda, Novo Nordisk) – the only GLP-1 agonist approved for weight management – in the 56-week SCALE trial (12.4% vs. 4.5%); however, the two studies had different populations.

The study was supported by Novo Nordisk. Dr. Ingelfinger is a deputy editor and Dr. Rosen is an associate editor of the New England Journal of Medicine. Dr. Ingelfinger, Dr. Rosen, and Dr. Leurent have reported no relevant financial relationships. Dr. O’Rahilly has a current research collaboration with Novo Nordisk scientists in an unrelated area and has been a consultant for the company.

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

The phase 3a STEP 1 trial that investigated the use of semaglutide (Novo Nordisk), a glucagonlike peptide–1 (GLP-1) agonist, for weight loss is aptly named, some say.

“In sum, we have a long way to go to control the obesity epidemic ... but on the face of it, the STEP 1 trial (like its name) is a good beginning,” wrote coeditorialists Julie R. Ingelfinger, MD, from Harvard Medical School, Boston, and a deputy editor of the New England Journal of Medicine, and Clifford J. Rosen, MD, from Tufts University School of Medicine, also in Boston.

The trial findings by John P.H. Wilding, DM, University of Liverpool (England), and colleagues and an accompanying editorial were published online Feb. 10, 2021, in the New England Journal of Medicine.

“The results are encouraging, with significantly more patients in the semaglutide group having clinically important weight loss,” Dr. Ingelfinger and Dr. Rosen stressed.

However, they also cautioned that “despite the positive results of this trial, the present study has some important limitations” and “there are concerns, including adverse events (mostly gastrointestinal – nausea, sometimes vomiting, and diarrhea) related primarily to the class of the agent.”

Two U.K. experts drew similar takeaways, speaking to the U.K. Science Media Centre.

“This was a well-designed study with unequivocal findings,” which showed that semaglutide “is indeed likely to be a game-changer in the fight against obesity,” according to Baptiste Leurent, PhD, London School of Hygiene and Tropical Medicine.

However, if the drug is approved at this dose for this use, patients would need close monitoring for gastrointestinal disorders, and “we also need to better understand what is happening once the treatment is stopped, and whether it could be taken for a shorter period of time.”

Sir Stephen O’Rahilly, MD, MRC Metabolic Diseases Unit, University of Cambridge (England), pointed out that “GLP-1 is made by cells in the intestine and levels increase in the blood after a meal, providing some of the signal to the brain that tells us we are ‘full,’ ” so GLP-1 agonists have been studied as appetite suppressants, in addition to their approved use to treat type 2 diabetes.

Only about 4.5% of participants in STEP 1 stopped taking semaglutide because of gastrointestinal issues, he noted, although more participants in that group reported problems with gallstones, which can follow rapid weight loss.

And “unlike some previous appetite suppressant drugs which caused significant psychological and psychiatric side effects, there is no evidence that semaglutide has any adverse effects of that nature,” Dr. O’Rahilly noted.

In sum, he said, “this is the start of a new era for obesity drug development with the future direction being to achieve levels of weight loss comparable to semaglutide, while having fewer side effects.”
 

‘Pressing need’ to address obesity; semaglutide filed for obesity

There is a “pressing need” to address the worldwide increase in obesity and weight-related coexisting conditions, Dr. Ingelfinger and Dr. Rosen noted.

Sustained long-term weight loss with diet and exercise is challenging; behavioral weight-loss strategies “fail more often than not,” bariatric surgery is invasive and often followed by eventual weight regain, they wrote.

In addition, said Dr. Wilding and colleagues, the “use of available [weight-loss] medications remains limited by modest efficacy, safety concerns, and cost.”

Subcutaneous semaglutide, approved for treating type 2 diabetes (as Ozempic) in adults at doses of up to 1 mg/week, induced weight loss at higher doses. The current study is part of the global Semaglutide Treatment Effect in People With Obesity program of four trials (STEP 1, 2, 3, and 4) that aimed to test the safety and efficacy of subcutaneous semaglutide 2.4 mg/week for weight loss.

Topline results from STEP 1 were presented June 4, 2020.

And as reported earlier, results from STEP 3 – a 68-week trial of semaglutide versus placebo in 611 participants who all received very intensive diet and exercise counseling – were presented at the virtual ObesityWeek 2020 meeting.

The four trials of semaglutide for weight loss have been completed and the data were submitted to the Food and Drug Administration on Dec. 4, 2020 (with a decision expected within 6 months) and to the European Medicines Agency on Dec. 18, 2020.
 

Most patients had 5% weight loss with semaglutide

The STEP 1 trial enrolled 1,961 adults with a body mass index (BMI) of at least 30 kg/m² or at least 27 with at least one weight-related coexisting condition, but without type 2 diabetes, at 129 sites in 16 countries in Asia, Europe, North America, and South America.

Participants were a mean age of 47 and three-quarters were women. Most participants were White (76%), followed by Asian (13%), Black or African American (6%), or other (5%).

On average, they had a BMI of 38 and weighed 105 kg. Three-quarters had one or more coexisting conditions.

Participants were randomized to receive semaglutide (1,306 patients) or placebo (655 patients), added to lifestyle intervention.

Everyone received 17 monthly individual counseling sessions during which they learned about adhering to a diet with a 500-calorie/day deficit, were encouraged to build up to walking 150 minutes each week, and recorded their daily diet and exercise (in a diary or using an app).

Semaglutide was administered with a prefilled pen injector at a dose of 0.25 mg/week for the first 4 weeks, escalated to 2.4 mg/week by week 16 (or lower if the patient had unacceptable side effects).

At 68 weeks, participants in the semaglutide versus placebo group had greater mean weight loss (14.9% vs. 2.4%, or 15.3 kg vs. 2.6 kg).

Participants in the semaglutide versus placebo group were much more likely to have lost at least 5% of their initial weight (86% vs. 31.5%) or at least 10% of their initial weight (69.1% vs. 12.0%), or at least 15% of their initial weight (50.5% vs. 4.9%; P < .001 for all three comparisons).

About 80% of participants adhered to the study treatment. A third of participants in the semaglutide group who completed the study lost at least 20% of their initial weight, which approaches the 20%-30% reported weight loss 1-3 years after sleeve gastrectomy, the researchers noted.

Participants in the semaglutide group also had greater improvements in waist circumference and levels of hemoglobin A1c, C-reactive protein (a marker of inflammation), and fasting lipids, as well as in physical function scores on SF-36 and IWQOL-Lite-CT questionnaires.

In their editorial, Dr. Ingelfinger and Dr. Rosen noted that “daily oral semaglutide [already approved in 7-mg and 14-mg doses for the treatment of type 2 diabetes as Rybelsus] might be more appealing to many people,” as a weight-loss medication than a once-weekly subcutaneous dose. Semaglutide is the first GLP-1 agonist available as an oral agent.

The ongoing Semaglutide Effects on Heart Disease and Stroke in Patients With Overweight or Obesity (SELECT) trial (with expected completion in 2023) will shed light on cardiovascular outcomes after 2.5-5 years.
 

GI disorders and ‘important limitations’

More participants in the semaglutide than the placebo group reported gastrointestinal disorders (typically nausea, diarrhea, vomiting, and constipation; 74.2% vs. 47.9%), which were mostly transient and mild to moderate in severity, but also led to more treatment discontinuation (7.0% vs. 3.1%).

More patients in the semaglutide versus placebo group had a gall bladder–related disorder (2.6% vs. 1.2%, mostly cholelithiasis) and mild acute pancreatitis (3 vs. 0 participants), but there were no between-group differences in neoplasms.

Dr. Wilding and colleagues acknowledge the limitations of the study, including the fact that it enrolled mainly women, mainly non-White participants, was relatively short, and excluded patients with type 2 diabetes.

Mean placebo-corrected weight loss with 2.4 mg/weekly subcutaneous semaglutide was greater than with 3.0 mg once-daily subcutaneous liraglutide (Saxenda, Novo Nordisk) – the only GLP-1 agonist approved for weight management – in the 56-week SCALE trial (12.4% vs. 4.5%); however, the two studies had different populations.

The study was supported by Novo Nordisk. Dr. Ingelfinger is a deputy editor and Dr. Rosen is an associate editor of the New England Journal of Medicine. Dr. Ingelfinger, Dr. Rosen, and Dr. Leurent have reported no relevant financial relationships. Dr. O’Rahilly has a current research collaboration with Novo Nordisk scientists in an unrelated area and has been a consultant for the company.

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

Pooled data from four phase 2 trials reveal that patients with recent SSRI exposure were significantly more likely to continue to meet PTSD diagnostic criteria after methylenedioxymethamphetamine (MDMA)-assisted psychotherapy than their peers who had not recently taken SSRIs.

Although preliminary, the findings have implications for clinical practice if MDMA-assisted psychotherapy is approved by the Food and Drug Administration, Allison Feduccia, PhD, study coauthor and founder of the education platform Psychedelic.Support, said in an interview.

“As psychedelic medicines become available, it’s going to be important that we try to understand what factors impact the response rate and if there are ways that we can improve the treatment outcomes. Allowing for a longer period for tapering completely off SSRIs before initiating MDMA sessions might increase the effectiveness of MDMA,” Dr. Feduccia said.

The study was published online Nov. 20, 2020, in Psychopharmacology (doi: 10.1007/s00213-020-05710-w).
 

Reduced response

The primary mechanism of action of MDMA involves the same reuptake transporters that are targeted by antidepressant medications commonly prescribed for PTSD. These medications include SSRIs, serotonin-norepinephrine reuptake inhibitors (SNRIs), NRIs, and norepinephrine-dopamine reuptake inhibitors (NDRIs).

Prior research shows that, when MDMA is coadministered with a reuptake inhibitor, subjective and psychological effects of the therapy are attenuated.

The researchers sought to determine whether or not recent tapering off of an antidepressant that targets the same primary binding sites as MDMA would affect treatment response. They analyzed data on 50 adults who underwent two sessions of MDMA-assisted psychotherapy in phase 2 clinical trials.

For 16 of these patients, SSRI therapy was tapered off prior to the MDMA sessions. For 34 patients, SSRI therapy was not tapered off, because the patients had not been taking the medication at the time of initial study screening (nontaper group).

The taper protocols specified that medications be tapered gradually over a period of weeks to minimize withdrawal symptoms and for them to be discontinued at least five half-lives of each drug prior to MDMA administration. Most participants were tapered off one drug, but some were tapered off multiple drugs.

Demographics, baseline PTSD, and depression severity were similar between the taper and the nontaper groups. Participants in the studies had chronic PTSD (symptoms lasting >6 months). Severity scores on the Clinician-Administered PTSD Scale for DSM IV (CAPS-IV) were at least 50.

After MDMA-assisted psychotherapy, the nontaper group had significantly lower (better) CAPS-IV total scores, compared with the taper group (mean, 45.7 vs. 70.3; P = .009).

About two-thirds (63.6%) of the nontaper group no longer met PTSD criteria after MDMA-assisted therapy, compared with only 25% of those in the taper group.

The nontaper group also had lower depression symptom severity scores on the Beck Depression Inventory–II, compared with the taper group (mean, 12.7 vs. 22.6; P = .010).

“Another really interesting” observation, said Dr. Feduccia, is that the expected increases in systolic and diastolic blood pressure following MDMA administration were reduced in the taper group, compared with the nontaper group.

“This suggests that MDMA didn’t have the same physiological response in individuals who tapered SSRIs. This should be followed up,” she said.

The investigators offerred several potential mechanisms for the negative effect of recent SSRI use on MDMA-assisted psychotherapy for PTSD.

These include the down-regulation of binding sites (serotonin, dopamine, and/or norepinephrine) related to SSRI use, reduced MDMA treatment-relevant increases in blood pressure in patients with recent SSRI use, and the possibility that withdrawal symptoms from SSRIs may reduce the effectiveness of MDMA psychotherapy.
 

Important clinical implications

In a comment, Steven R. Thorp, PhD, professor at Alliant International University, San Diego, said the findings are “very interesting” and likely “not well known.”

“There has been great interest in MDMA-assisted psychotherapy in recent years, and if this finding is replicated, it will have important implications for that research,” Dr. Thorp said.

“Although psychotherapy is often preferred by clients with PTSD, compared to medications, and typically shows efficacy that is as strong or stronger (and longer lasting) than medications, many individuals with PTSD are provided with medication only,” Dr. Thorp noted.

“This study suggests that, in addition to the other potential disadvantages of medications (e.g., cost, side effects, potential for addiction), those who take SSRIs, SNRIs, NRIs, and NDRIs for PTSD may also benefit less from MDMA-assisted psychotherapy,” Dr. Thorp added.

The four phase 2 studies used in the analysis were sponsored by the Multidisciplinary Association for Psychedelic Studies, a nonprofit organization. Dr. Feduccia received salary support for full-time employment with MAPS Public Benefit Corporation. Dr. Thorp disclosed no relevant financial relationships.

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

Pooled data from four phase 2 trials reveal that patients with recent SSRI exposure were significantly more likely to continue to meet PTSD diagnostic criteria after methylenedioxymethamphetamine (MDMA)-assisted psychotherapy than their peers who had not recently taken SSRIs.

Although preliminary, the findings have implications for clinical practice if MDMA-assisted psychotherapy is approved by the Food and Drug Administration, Allison Feduccia, PhD, study coauthor and founder of the education platform Psychedelic.Support, said in an interview.

“As psychedelic medicines become available, it’s going to be important that we try to understand what factors impact the response rate and if there are ways that we can improve the treatment outcomes. Allowing for a longer period for tapering completely off SSRIs before initiating MDMA sessions might increase the effectiveness of MDMA,” Dr. Feduccia said.

The study was published online Nov. 20, 2020, in Psychopharmacology (doi: 10.1007/s00213-020-05710-w).
 

Reduced response

The primary mechanism of action of MDMA involves the same reuptake transporters that are targeted by antidepressant medications commonly prescribed for PTSD. These medications include SSRIs, serotonin-norepinephrine reuptake inhibitors (SNRIs), NRIs, and norepinephrine-dopamine reuptake inhibitors (NDRIs).

Prior research shows that, when MDMA is coadministered with a reuptake inhibitor, subjective and psychological effects of the therapy are attenuated.

The researchers sought to determine whether or not recent tapering off of an antidepressant that targets the same primary binding sites as MDMA would affect treatment response. They analyzed data on 50 adults who underwent two sessions of MDMA-assisted psychotherapy in phase 2 clinical trials.

For 16 of these patients, SSRI therapy was tapered off prior to the MDMA sessions. For 34 patients, SSRI therapy was not tapered off, because the patients had not been taking the medication at the time of initial study screening (nontaper group).

The taper protocols specified that medications be tapered gradually over a period of weeks to minimize withdrawal symptoms and for them to be discontinued at least five half-lives of each drug prior to MDMA administration. Most participants were tapered off one drug, but some were tapered off multiple drugs.

Demographics, baseline PTSD, and depression severity were similar between the taper and the nontaper groups. Participants in the studies had chronic PTSD (symptoms lasting >6 months). Severity scores on the Clinician-Administered PTSD Scale for DSM IV (CAPS-IV) were at least 50.

After MDMA-assisted psychotherapy, the nontaper group had significantly lower (better) CAPS-IV total scores, compared with the taper group (mean, 45.7 vs. 70.3; P = .009).

About two-thirds (63.6%) of the nontaper group no longer met PTSD criteria after MDMA-assisted therapy, compared with only 25% of those in the taper group.

The nontaper group also had lower depression symptom severity scores on the Beck Depression Inventory–II, compared with the taper group (mean, 12.7 vs. 22.6; P = .010).

“Another really interesting” observation, said Dr. Feduccia, is that the expected increases in systolic and diastolic blood pressure following MDMA administration were reduced in the taper group, compared with the nontaper group.

“This suggests that MDMA didn’t have the same physiological response in individuals who tapered SSRIs. This should be followed up,” she said.

The investigators offerred several potential mechanisms for the negative effect of recent SSRI use on MDMA-assisted psychotherapy for PTSD.

These include the down-regulation of binding sites (serotonin, dopamine, and/or norepinephrine) related to SSRI use, reduced MDMA treatment-relevant increases in blood pressure in patients with recent SSRI use, and the possibility that withdrawal symptoms from SSRIs may reduce the effectiveness of MDMA psychotherapy.
 

Important clinical implications

In a comment, Steven R. Thorp, PhD, professor at Alliant International University, San Diego, said the findings are “very interesting” and likely “not well known.”

“There has been great interest in MDMA-assisted psychotherapy in recent years, and if this finding is replicated, it will have important implications for that research,” Dr. Thorp said.

“Although psychotherapy is often preferred by clients with PTSD, compared to medications, and typically shows efficacy that is as strong or stronger (and longer lasting) than medications, many individuals with PTSD are provided with medication only,” Dr. Thorp noted.

“This study suggests that, in addition to the other potential disadvantages of medications (e.g., cost, side effects, potential for addiction), those who take SSRIs, SNRIs, NRIs, and NDRIs for PTSD may also benefit less from MDMA-assisted psychotherapy,” Dr. Thorp added.

The four phase 2 studies used in the analysis were sponsored by the Multidisciplinary Association for Psychedelic Studies, a nonprofit organization. Dr. Feduccia received salary support for full-time employment with MAPS Public Benefit Corporation. Dr. Thorp disclosed no relevant financial relationships.

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

Pooled data from four phase 2 trials reveal that patients with recent SSRI exposure were significantly more likely to continue to meet PTSD diagnostic criteria after methylenedioxymethamphetamine (MDMA)-assisted psychotherapy than their peers who had not recently taken SSRIs.

Although preliminary, the findings have implications for clinical practice if MDMA-assisted psychotherapy is approved by the Food and Drug Administration, Allison Feduccia, PhD, study coauthor and founder of the education platform Psychedelic.Support, said in an interview.

“As psychedelic medicines become available, it’s going to be important that we try to understand what factors impact the response rate and if there are ways that we can improve the treatment outcomes. Allowing for a longer period for tapering completely off SSRIs before initiating MDMA sessions might increase the effectiveness of MDMA,” Dr. Feduccia said.

The study was published online Nov. 20, 2020, in Psychopharmacology (doi: 10.1007/s00213-020-05710-w).
 

Reduced response

The primary mechanism of action of MDMA involves the same reuptake transporters that are targeted by antidepressant medications commonly prescribed for PTSD. These medications include SSRIs, serotonin-norepinephrine reuptake inhibitors (SNRIs), NRIs, and norepinephrine-dopamine reuptake inhibitors (NDRIs).

Prior research shows that, when MDMA is coadministered with a reuptake inhibitor, subjective and psychological effects of the therapy are attenuated.

The researchers sought to determine whether or not recent tapering off of an antidepressant that targets the same primary binding sites as MDMA would affect treatment response. They analyzed data on 50 adults who underwent two sessions of MDMA-assisted psychotherapy in phase 2 clinical trials.

For 16 of these patients, SSRI therapy was tapered off prior to the MDMA sessions. For 34 patients, SSRI therapy was not tapered off, because the patients had not been taking the medication at the time of initial study screening (nontaper group).

The taper protocols specified that medications be tapered gradually over a period of weeks to minimize withdrawal symptoms and for them to be discontinued at least five half-lives of each drug prior to MDMA administration. Most participants were tapered off one drug, but some were tapered off multiple drugs.

Demographics, baseline PTSD, and depression severity were similar between the taper and the nontaper groups. Participants in the studies had chronic PTSD (symptoms lasting >6 months). Severity scores on the Clinician-Administered PTSD Scale for DSM IV (CAPS-IV) were at least 50.

After MDMA-assisted psychotherapy, the nontaper group had significantly lower (better) CAPS-IV total scores, compared with the taper group (mean, 45.7 vs. 70.3; P = .009).

About two-thirds (63.6%) of the nontaper group no longer met PTSD criteria after MDMA-assisted therapy, compared with only 25% of those in the taper group.

The nontaper group also had lower depression symptom severity scores on the Beck Depression Inventory–II, compared with the taper group (mean, 12.7 vs. 22.6; P = .010).

“Another really interesting” observation, said Dr. Feduccia, is that the expected increases in systolic and diastolic blood pressure following MDMA administration were reduced in the taper group, compared with the nontaper group.

“This suggests that MDMA didn’t have the same physiological response in individuals who tapered SSRIs. This should be followed up,” she said.

The investigators offerred several potential mechanisms for the negative effect of recent SSRI use on MDMA-assisted psychotherapy for PTSD.

These include the down-regulation of binding sites (serotonin, dopamine, and/or norepinephrine) related to SSRI use, reduced MDMA treatment-relevant increases in blood pressure in patients with recent SSRI use, and the possibility that withdrawal symptoms from SSRIs may reduce the effectiveness of MDMA psychotherapy.
 

Important clinical implications

In a comment, Steven R. Thorp, PhD, professor at Alliant International University, San Diego, said the findings are “very interesting” and likely “not well known.”

“There has been great interest in MDMA-assisted psychotherapy in recent years, and if this finding is replicated, it will have important implications for that research,” Dr. Thorp said.

“Although psychotherapy is often preferred by clients with PTSD, compared to medications, and typically shows efficacy that is as strong or stronger (and longer lasting) than medications, many individuals with PTSD are provided with medication only,” Dr. Thorp noted.

“This study suggests that, in addition to the other potential disadvantages of medications (e.g., cost, side effects, potential for addiction), those who take SSRIs, SNRIs, NRIs, and NDRIs for PTSD may also benefit less from MDMA-assisted psychotherapy,” Dr. Thorp added.

The four phase 2 studies used in the analysis were sponsored by the Multidisciplinary Association for Psychedelic Studies, a nonprofit organization. Dr. Feduccia received salary support for full-time employment with MAPS Public Benefit Corporation. Dr. Thorp disclosed no relevant financial relationships.

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