Adolescent Medicine

Treatment with deuruxolitinib and ritlecitinib, two investigational Janus kinase (JAK) inhibitors, resulted in substantial regrowth of scalp hair for patients with alopecia areata (AA) in separate studies reported at the annual congress of the European Academy of Dermatology and Venereology.

In the THRIVE-AA1 study, the primary endpoint of a Severity of Alopecia Tool (SALT) score of 20 or lower –which indicates that hair regrowth has occurred on at least 80% of the scalp – was achieved among patients taking deuruxolitinib, which was a significantly higher proportion than with placebo (P < .0001). Importantly, the JAK inhibitor’s effects were seen in as early as 4 weeks, and there was significant improvement in both eyelash and eyebrow hair regrowth.

In the unrelated ALLEGRO-LT study, effects from treatment with the JAK inhibitor ritlecitinib appeared to be sustained for 2 years; 69.6% of patients treated with ritlecitinib had a SALT score of 20 or lower by 24 months.

These data are “very exciting for alopecia areata because the patients selected are very severe,” observed Mahtab Samimi, MD, PhD, who cochaired the late-breaking session in which the study findings were discussed.

THRIVE-AA1 included only patients with hair loss of 50% or more. The ALLEGRO-LT study included patients with total scalp or total body hair loss (areata totalis/areata universalis) of 25%-50% at enrollment.

Moreover, “very stringent criteria” were used. SALT scores of 10 or less were evaluated in both studies, observed Dr. Samimi, professor of dermatology at the University of Tours (France).

“We can be ambitious now for our patients with alopecia areata; that’s really good news,” Dr. Samimi added.

Deuruxolitinib and the THRIVE trials

Deuruxolitinib is an oral JAK1/JAK2 inhibitor that has been tested in two similarly designed, multinational, randomized, double-blind, placebo-controlled phase 3 trials in patients with AA, THRIVE-AA1 and THRIVE-AA2.

Two doses of deuruxolitinib, 8 mg and 12 mg given twice daily, were evaluated in the trials, which altogether included just over 1,200 patients.

Results of THRIVE-AA1 have been reported by the manufacturer. Brett King, MD, PhD, associate professor of dermatology, Yale University, New Haven, Conn., presented a more comprehensive review at the EADV meeting.

He reported that at 24 weeks, SALT scores of 20 or lower were achieved by 30% of adults with AA who were treated with deuruxolitinib 8 mg and by 42% of those treated with deuruxolitinib 12 mg. This primary endpoint was seen in only 1% of the placebo-treated patients.

The more stringent endpoint of having a SALT score of 10 or less, which indicates that hair regrowth has occurred over 90% of the scalp, was met by 21% of patients who received deuruxolitinib 8 mg twice a day and by 35% of those who received the 12-mg dose twice a day at 24 weeks. This endpoint was not reached by any of the placebo-treated patients.

“This is truly transformative therapy,” Dr. King said when presenting the findings. “We know that the chances of spontaneous remission when you have severe disease is next to zero,” he added.

There were reasonably high rates of patient satisfaction with the treatment, according to Dr. King. He said that 42% of those who took 8 mg twice a day and 53% of those who took 12 mg twice a day said they were “very satisfied” or “satisfied” with the degree of scalp hair regrowth achieved, compared with 5% for placebo.

Safety was as expected, and there were no signs of any blood clots, said Dr. King. Common treatment-emergent adverse events (TEAEs) that affected 5% or more of patients included acne and headache. Serious TEAEs were reported by 1.1% and 0.5% of those taking the 8-mg and 12-mg twice-daily doses, respectively, compared with 2.9% of those who received placebo.

Overall, the results look promising for deuruxolitinib, he added. He noted that almost all patients included in the trial have opted to continue in the open-label long-term safety study.

Prescribing information of the JAK inhibitors approved by the U.S. Food and Drug Administration includes a boxed warning about risk of serious infections, mortality, malignancy, major adverse cardiovascular events (MACE), and thrombosis. The warning is based on experience with another JAK inhibitor for patients with rheumatoid arthritis.
 

Ritlecitinib and the ALLEGRO studies

Interim results of the ongoing, open-label, phase 3 ALLEGRO-LT study with ritlecitinib were presented separately by Athanasios Tsianakas, MD, head of the department of dermatology at Fachklinik Bad Bentheim, Germany.

Ritlecitinib, which targets JAK3 and also the TEC family of tyrosine kinases, had met all of its endpoints in the prior ALLEGRO Phase 2b/3 study, Dr. Tsianakas said. Those included the benchmarks of a SALT score of 20 or less and a SALT score of 10 or less.

“Ritlecitinib showed a very good long-term efficacy and good safety profile in our adolescent and adult patients suffering from alopecia areata,” said Dr. Tsianakas.

A total of 447 patients were included in the trial. They were treated with 50 mg of ritlecitinib every day; some had already participated in the ALLEGRO trial, while others had been newly recruited. The latter group entered the trial after a 4-week run-in period, during which a 200-mg daily loading dose was given for 4 weeks.

Most (86%) patients had been exposed to ritlecitinib for at least 12 months; one-fifth had discontinued treatment at the data cutoff, generally because the patients no longer met the eligibility criteria for the trial.

Safety was paramount, Dr. Tsianakas highlighted. There were few adverse events that led to temporary or permanent discontinuation of the study drug. The most common TEAEs that affected 5% or more of patients included headache and acne. There were two cases of MACE (one nonfatal myocardial infarction and one nonfatal stroke).

The proportion of patients with a SALT score of 20 or less was 2.5% at 1 month, 27.9% at 3 months, 50.1% at 6 months, 59.8% at 9 months, and 65.5% at 12 months. Thereafter, there was little shift in the response. A sustained effect, in which a SALT score of 20 or less was seen out to 24 months, occurred in 69.9% of patients.

A similar pattern was seen for SALT scores of 10 or less, ranging from 16.5% at 3 months to 62.5% at 24 months.
 

Following in baricitinib’s footsteps?

This not the first time that JAK inhibitors have been shown to have beneficial effects for patients with AA. Baricitinib (Olumiant) recently became the first JAK inhibitor to be granted marketing approval for AA in the United States, largely on the basis of two pivotal phase 3 studies, BRAVE-AA1 and BRAVE-AA2.

“This is just such an incredibly exciting time,” said Dr. King. “Our discoveries in the lab are being translated into effective therapies for patients with diseases for which we’ve not previously had therapies,” he commented.

“Our concept of interferon gamma– and interleukin-15–mediated disease is probably not true for everybody,” said, Dr. King, who acknowledged that some patients with AA do not respond to JAK-inhibitor therapy or may need additional or alternative treatment.

“It’s probably not that homogeneous a disease,” he added. “It’s fascinating that the very first drugs for this disease are showing efficacy in as many patients as they are.”

The THRIVE-AAI study was funded by CONCERT Pharmaceuticals. Dr. King has served on advisory boards, has provided consulting services to, or has been a trial investigator for multiple pharmaceutical companies, including CoNCERT Pharmaceuticals. The ALLEGRO-LT study was funded by Pfizer. Dr. Tsianakas has acted as a clinical trial investigator and speaker for Pfizer.

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

Treatment with deuruxolitinib and ritlecitinib, two investigational Janus kinase (JAK) inhibitors, resulted in substantial regrowth of scalp hair for patients with alopecia areata (AA) in separate studies reported at the annual congress of the European Academy of Dermatology and Venereology.

In the THRIVE-AA1 study, the primary endpoint of a Severity of Alopecia Tool (SALT) score of 20 or lower –which indicates that hair regrowth has occurred on at least 80% of the scalp – was achieved among patients taking deuruxolitinib, which was a significantly higher proportion than with placebo (P < .0001). Importantly, the JAK inhibitor’s effects were seen in as early as 4 weeks, and there was significant improvement in both eyelash and eyebrow hair regrowth.

In the unrelated ALLEGRO-LT study, effects from treatment with the JAK inhibitor ritlecitinib appeared to be sustained for 2 years; 69.6% of patients treated with ritlecitinib had a SALT score of 20 or lower by 24 months.

These data are “very exciting for alopecia areata because the patients selected are very severe,” observed Mahtab Samimi, MD, PhD, who cochaired the late-breaking session in which the study findings were discussed.

THRIVE-AA1 included only patients with hair loss of 50% or more. The ALLEGRO-LT study included patients with total scalp or total body hair loss (areata totalis/areata universalis) of 25%-50% at enrollment.

Moreover, “very stringent criteria” were used. SALT scores of 10 or less were evaluated in both studies, observed Dr. Samimi, professor of dermatology at the University of Tours (France).

“We can be ambitious now for our patients with alopecia areata; that’s really good news,” Dr. Samimi added.

Deuruxolitinib and the THRIVE trials

Deuruxolitinib is an oral JAK1/JAK2 inhibitor that has been tested in two similarly designed, multinational, randomized, double-blind, placebo-controlled phase 3 trials in patients with AA, THRIVE-AA1 and THRIVE-AA2.

Two doses of deuruxolitinib, 8 mg and 12 mg given twice daily, were evaluated in the trials, which altogether included just over 1,200 patients.

Results of THRIVE-AA1 have been reported by the manufacturer. Brett King, MD, PhD, associate professor of dermatology, Yale University, New Haven, Conn., presented a more comprehensive review at the EADV meeting.

He reported that at 24 weeks, SALT scores of 20 or lower were achieved by 30% of adults with AA who were treated with deuruxolitinib 8 mg and by 42% of those treated with deuruxolitinib 12 mg. This primary endpoint was seen in only 1% of the placebo-treated patients.

The more stringent endpoint of having a SALT score of 10 or less, which indicates that hair regrowth has occurred over 90% of the scalp, was met by 21% of patients who received deuruxolitinib 8 mg twice a day and by 35% of those who received the 12-mg dose twice a day at 24 weeks. This endpoint was not reached by any of the placebo-treated patients.

“This is truly transformative therapy,” Dr. King said when presenting the findings. “We know that the chances of spontaneous remission when you have severe disease is next to zero,” he added.

There were reasonably high rates of patient satisfaction with the treatment, according to Dr. King. He said that 42% of those who took 8 mg twice a day and 53% of those who took 12 mg twice a day said they were “very satisfied” or “satisfied” with the degree of scalp hair regrowth achieved, compared with 5% for placebo.

Safety was as expected, and there were no signs of any blood clots, said Dr. King. Common treatment-emergent adverse events (TEAEs) that affected 5% or more of patients included acne and headache. Serious TEAEs were reported by 1.1% and 0.5% of those taking the 8-mg and 12-mg twice-daily doses, respectively, compared with 2.9% of those who received placebo.

Overall, the results look promising for deuruxolitinib, he added. He noted that almost all patients included in the trial have opted to continue in the open-label long-term safety study.

Prescribing information of the JAK inhibitors approved by the U.S. Food and Drug Administration includes a boxed warning about risk of serious infections, mortality, malignancy, major adverse cardiovascular events (MACE), and thrombosis. The warning is based on experience with another JAK inhibitor for patients with rheumatoid arthritis.
 

Ritlecitinib and the ALLEGRO studies

Interim results of the ongoing, open-label, phase 3 ALLEGRO-LT study with ritlecitinib were presented separately by Athanasios Tsianakas, MD, head of the department of dermatology at Fachklinik Bad Bentheim, Germany.

Ritlecitinib, which targets JAK3 and also the TEC family of tyrosine kinases, had met all of its endpoints in the prior ALLEGRO Phase 2b/3 study, Dr. Tsianakas said. Those included the benchmarks of a SALT score of 20 or less and a SALT score of 10 or less.

“Ritlecitinib showed a very good long-term efficacy and good safety profile in our adolescent and adult patients suffering from alopecia areata,” said Dr. Tsianakas.

A total of 447 patients were included in the trial. They were treated with 50 mg of ritlecitinib every day; some had already participated in the ALLEGRO trial, while others had been newly recruited. The latter group entered the trial after a 4-week run-in period, during which a 200-mg daily loading dose was given for 4 weeks.

Most (86%) patients had been exposed to ritlecitinib for at least 12 months; one-fifth had discontinued treatment at the data cutoff, generally because the patients no longer met the eligibility criteria for the trial.

Safety was paramount, Dr. Tsianakas highlighted. There were few adverse events that led to temporary or permanent discontinuation of the study drug. The most common TEAEs that affected 5% or more of patients included headache and acne. There were two cases of MACE (one nonfatal myocardial infarction and one nonfatal stroke).

The proportion of patients with a SALT score of 20 or less was 2.5% at 1 month, 27.9% at 3 months, 50.1% at 6 months, 59.8% at 9 months, and 65.5% at 12 months. Thereafter, there was little shift in the response. A sustained effect, in which a SALT score of 20 or less was seen out to 24 months, occurred in 69.9% of patients.

A similar pattern was seen for SALT scores of 10 or less, ranging from 16.5% at 3 months to 62.5% at 24 months.
 

Following in baricitinib’s footsteps?

This not the first time that JAK inhibitors have been shown to have beneficial effects for patients with AA. Baricitinib (Olumiant) recently became the first JAK inhibitor to be granted marketing approval for AA in the United States, largely on the basis of two pivotal phase 3 studies, BRAVE-AA1 and BRAVE-AA2.

“This is just such an incredibly exciting time,” said Dr. King. “Our discoveries in the lab are being translated into effective therapies for patients with diseases for which we’ve not previously had therapies,” he commented.

“Our concept of interferon gamma– and interleukin-15–mediated disease is probably not true for everybody,” said, Dr. King, who acknowledged that some patients with AA do not respond to JAK-inhibitor therapy or may need additional or alternative treatment.

“It’s probably not that homogeneous a disease,” he added. “It’s fascinating that the very first drugs for this disease are showing efficacy in as many patients as they are.”

The THRIVE-AAI study was funded by CONCERT Pharmaceuticals. Dr. King has served on advisory boards, has provided consulting services to, or has been a trial investigator for multiple pharmaceutical companies, including CoNCERT Pharmaceuticals. The ALLEGRO-LT study was funded by Pfizer. Dr. Tsianakas has acted as a clinical trial investigator and speaker for Pfizer.

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

Treatment with deuruxolitinib and ritlecitinib, two investigational Janus kinase (JAK) inhibitors, resulted in substantial regrowth of scalp hair for patients with alopecia areata (AA) in separate studies reported at the annual congress of the European Academy of Dermatology and Venereology.

In the THRIVE-AA1 study, the primary endpoint of a Severity of Alopecia Tool (SALT) score of 20 or lower –which indicates that hair regrowth has occurred on at least 80% of the scalp – was achieved among patients taking deuruxolitinib, which was a significantly higher proportion than with placebo (P < .0001). Importantly, the JAK inhibitor’s effects were seen in as early as 4 weeks, and there was significant improvement in both eyelash and eyebrow hair regrowth.

In the unrelated ALLEGRO-LT study, effects from treatment with the JAK inhibitor ritlecitinib appeared to be sustained for 2 years; 69.6% of patients treated with ritlecitinib had a SALT score of 20 or lower by 24 months.

These data are “very exciting for alopecia areata because the patients selected are very severe,” observed Mahtab Samimi, MD, PhD, who cochaired the late-breaking session in which the study findings were discussed.

THRIVE-AA1 included only patients with hair loss of 50% or more. The ALLEGRO-LT study included patients with total scalp or total body hair loss (areata totalis/areata universalis) of 25%-50% at enrollment.

Moreover, “very stringent criteria” were used. SALT scores of 10 or less were evaluated in both studies, observed Dr. Samimi, professor of dermatology at the University of Tours (France).

“We can be ambitious now for our patients with alopecia areata; that’s really good news,” Dr. Samimi added.

Deuruxolitinib and the THRIVE trials

Deuruxolitinib is an oral JAK1/JAK2 inhibitor that has been tested in two similarly designed, multinational, randomized, double-blind, placebo-controlled phase 3 trials in patients with AA, THRIVE-AA1 and THRIVE-AA2.

Two doses of deuruxolitinib, 8 mg and 12 mg given twice daily, were evaluated in the trials, which altogether included just over 1,200 patients.

Results of THRIVE-AA1 have been reported by the manufacturer. Brett King, MD, PhD, associate professor of dermatology, Yale University, New Haven, Conn., presented a more comprehensive review at the EADV meeting.

He reported that at 24 weeks, SALT scores of 20 or lower were achieved by 30% of adults with AA who were treated with deuruxolitinib 8 mg and by 42% of those treated with deuruxolitinib 12 mg. This primary endpoint was seen in only 1% of the placebo-treated patients.

The more stringent endpoint of having a SALT score of 10 or less, which indicates that hair regrowth has occurred over 90% of the scalp, was met by 21% of patients who received deuruxolitinib 8 mg twice a day and by 35% of those who received the 12-mg dose twice a day at 24 weeks. This endpoint was not reached by any of the placebo-treated patients.

“This is truly transformative therapy,” Dr. King said when presenting the findings. “We know that the chances of spontaneous remission when you have severe disease is next to zero,” he added.

There were reasonably high rates of patient satisfaction with the treatment, according to Dr. King. He said that 42% of those who took 8 mg twice a day and 53% of those who took 12 mg twice a day said they were “very satisfied” or “satisfied” with the degree of scalp hair regrowth achieved, compared with 5% for placebo.

Safety was as expected, and there were no signs of any blood clots, said Dr. King. Common treatment-emergent adverse events (TEAEs) that affected 5% or more of patients included acne and headache. Serious TEAEs were reported by 1.1% and 0.5% of those taking the 8-mg and 12-mg twice-daily doses, respectively, compared with 2.9% of those who received placebo.

Overall, the results look promising for deuruxolitinib, he added. He noted that almost all patients included in the trial have opted to continue in the open-label long-term safety study.

Prescribing information of the JAK inhibitors approved by the U.S. Food and Drug Administration includes a boxed warning about risk of serious infections, mortality, malignancy, major adverse cardiovascular events (MACE), and thrombosis. The warning is based on experience with another JAK inhibitor for patients with rheumatoid arthritis.
 

Ritlecitinib and the ALLEGRO studies

Interim results of the ongoing, open-label, phase 3 ALLEGRO-LT study with ritlecitinib were presented separately by Athanasios Tsianakas, MD, head of the department of dermatology at Fachklinik Bad Bentheim, Germany.

Ritlecitinib, which targets JAK3 and also the TEC family of tyrosine kinases, had met all of its endpoints in the prior ALLEGRO Phase 2b/3 study, Dr. Tsianakas said. Those included the benchmarks of a SALT score of 20 or less and a SALT score of 10 or less.

“Ritlecitinib showed a very good long-term efficacy and good safety profile in our adolescent and adult patients suffering from alopecia areata,” said Dr. Tsianakas.

A total of 447 patients were included in the trial. They were treated with 50 mg of ritlecitinib every day; some had already participated in the ALLEGRO trial, while others had been newly recruited. The latter group entered the trial after a 4-week run-in period, during which a 200-mg daily loading dose was given for 4 weeks.

Most (86%) patients had been exposed to ritlecitinib for at least 12 months; one-fifth had discontinued treatment at the data cutoff, generally because the patients no longer met the eligibility criteria for the trial.

Safety was paramount, Dr. Tsianakas highlighted. There were few adverse events that led to temporary or permanent discontinuation of the study drug. The most common TEAEs that affected 5% or more of patients included headache and acne. There were two cases of MACE (one nonfatal myocardial infarction and one nonfatal stroke).

The proportion of patients with a SALT score of 20 or less was 2.5% at 1 month, 27.9% at 3 months, 50.1% at 6 months, 59.8% at 9 months, and 65.5% at 12 months. Thereafter, there was little shift in the response. A sustained effect, in which a SALT score of 20 or less was seen out to 24 months, occurred in 69.9% of patients.

A similar pattern was seen for SALT scores of 10 or less, ranging from 16.5% at 3 months to 62.5% at 24 months.
 

Following in baricitinib’s footsteps?

This not the first time that JAK inhibitors have been shown to have beneficial effects for patients with AA. Baricitinib (Olumiant) recently became the first JAK inhibitor to be granted marketing approval for AA in the United States, largely on the basis of two pivotal phase 3 studies, BRAVE-AA1 and BRAVE-AA2.

“This is just such an incredibly exciting time,” said Dr. King. “Our discoveries in the lab are being translated into effective therapies for patients with diseases for which we’ve not previously had therapies,” he commented.

“Our concept of interferon gamma– and interleukin-15–mediated disease is probably not true for everybody,” said, Dr. King, who acknowledged that some patients with AA do not respond to JAK-inhibitor therapy or may need additional or alternative treatment.

“It’s probably not that homogeneous a disease,” he added. “It’s fascinating that the very first drugs for this disease are showing efficacy in as many patients as they are.”

The THRIVE-AAI study was funded by CONCERT Pharmaceuticals. Dr. King has served on advisory boards, has provided consulting services to, or has been a trial investigator for multiple pharmaceutical companies, including CoNCERT Pharmaceuticals. The ALLEGRO-LT study was funded by Pfizer. Dr. Tsianakas has acted as a clinical trial investigator and speaker for Pfizer.

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

The COVID-19 pandemic has been associated with the development of anorexia nervosa in Canadian children and adolescents, data suggest.

Preliminary results of the Canadian Paediatric Surveillance Program (CPSP) indicate that the pandemic has been a precipitating factor in the development of anorexia nervosa in almost half of children and adolescents studied. The pandemic also has precipitated hospitalizations for anorexia in more than one-third of cases.

“Data globally, and certainly our data here in Canada, have shown a real increase in health care utilization with the onset of the COVID-19 pandemic,” study author Debra Katzman, MD, professor of pediatrics at the Hospital for Sick Children in Toronto and the University of Toronto, said in an interview. “And when I talk about health care utilization, I’m talking about hospitalizations for eating disorders.”

The data were included in the 2021 results of the CPSP.
 

Focus on appearance

CPSP is a collaboration between the Public Health Agency of Canada and the Canadian Pediatric Society that consists of a network of 2,800 pediatricians and pediatric subspecialists across Canada. The latest results include surveillance studies on 14 diseases and conditions, with data collected during various periods.

From April 2020 to May 2021, researchers identified 1,800 COVID-19 cases in children and collected detailed information on 1,456 of them, including 405 cases hospitalized with pediatric inflammatory multisystem syndrome (PIMS). The median age of hospitalized cases was 3.2 years for SARS-CoV-2 infection and 5.4 years for PIMS.

Dr. Katzman and colleagues observed 118 first-time hospitalizations for anorexia nervosa between Sept. 1 and Dec. 31, 2021. More than 90% of reported cases were female, with 66% of verified cases in teens aged 14-17 years and the remainder in adolescents aged 11-13 years.

In 49% of cases, the reporting physician identified the COVID-19 pandemic as a precipitating factor in the development of anorexia nervosa. In 37% of cases, the reporting physician identified the pandemic as having precipitated the anorexia-related hospitalization.

Last year, a cross-sectional analysis of children in Canada reported that monthly hospitalizations for anorexia nervosa increased from 7.5 to 20 from March through November 2020. The monthly rate in the CPSP study was closer to 30 for first-time hospitalizations.

Dr. Katzman said that the findings about anorexia nervosa didn’t surprise her. “There was so much disruption and [so many] restrictions to young peoples’ daily routines – closures of schools and recreational activities – they lost regular connection with their peers, and they lost extracurricular and social activities,” she said. “That led to heightened anxiety and depression and really a lack of control.”

Adolescents and teens were also spending more time on social media than they were before the pandemic, she noted. “They were looking at themselves all the time, so they were getting preoccupied with their body image. There was a heightened focus on appearance, and I think that things like public-health mitigation strategies – things like hand washing, social distancing, mask wearing – may have impacted the psychological well-being of young people.”

The closure of outpatient facilities, long waiting lists to get into facilities that were opened, and “coronaphobia” about going to physicians’ offices and emergency departments compounded the problem, Dr. Katzman added.

The long-term effects of COVID and eating disorders in children are unknown, Dr. Katzman said. “This is sort of a wake-up call for the health care system that during times of stress or pandemics or crises, these kinds of things can happen, and we need to be prepared to provide the resources for vulnerable populations moving forward,” she said.
 

Heightened anxiety

Commenting on the data, Margaret Thew, APNP, director of the eating disorders program at Children’s Wisconsin in Milwaukee, said that isolation due to school closures and negative social media messages created the “perfect storm” for eating disorders in adolescents and teenagers because of higher rates of anxiety and depression. Ms. Thew was not involved in the research.

The storm is not over yet, she said. “What everyone needs to keep in mind is that we still have this very heightened state of anxiety and depression ... for adolescents, teenagers, and preteens alike,” Ms. Thew said in an interview, “and we know that many of them are not coping with their anxiety very well.”

In her experience, since the start of the pandemic, the average age of pediatric patients with eating disorders declined from 16 to 15 years, and the youngest age declined from 12 to 11 years.

Overall, the CPSP results show that children are affected by mental health issues at an earlier age than before the pandemic, said Ms. Thew. “Years ago, we wouldn’t have thought that an 8-year-old needed to be screened for some of these risk factors, but now we’re definitely getting more younger children who are struggling, and I think it’s taking too long for them to get the care they need because it’s being overlooked,” she said.

The report was funded by the Public Health Agency of Canada, Health Canada, Alberta Children’s Hospital Research Institute, Bethanys Hope Foundation, CHEO Research Institute, and Children’s Hospital Research Institute of Manitoba. Dr. Katzman and Ms. Thew have no relevant disclosures.

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

The COVID-19 pandemic has been associated with the development of anorexia nervosa in Canadian children and adolescents, data suggest.

Preliminary results of the Canadian Paediatric Surveillance Program (CPSP) indicate that the pandemic has been a precipitating factor in the development of anorexia nervosa in almost half of children and adolescents studied. The pandemic also has precipitated hospitalizations for anorexia in more than one-third of cases.

“Data globally, and certainly our data here in Canada, have shown a real increase in health care utilization with the onset of the COVID-19 pandemic,” study author Debra Katzman, MD, professor of pediatrics at the Hospital for Sick Children in Toronto and the University of Toronto, said in an interview. “And when I talk about health care utilization, I’m talking about hospitalizations for eating disorders.”

The data were included in the 2021 results of the CPSP.
 

Focus on appearance

CPSP is a collaboration between the Public Health Agency of Canada and the Canadian Pediatric Society that consists of a network of 2,800 pediatricians and pediatric subspecialists across Canada. The latest results include surveillance studies on 14 diseases and conditions, with data collected during various periods.

From April 2020 to May 2021, researchers identified 1,800 COVID-19 cases in children and collected detailed information on 1,456 of them, including 405 cases hospitalized with pediatric inflammatory multisystem syndrome (PIMS). The median age of hospitalized cases was 3.2 years for SARS-CoV-2 infection and 5.4 years for PIMS.

Dr. Katzman and colleagues observed 118 first-time hospitalizations for anorexia nervosa between Sept. 1 and Dec. 31, 2021. More than 90% of reported cases were female, with 66% of verified cases in teens aged 14-17 years and the remainder in adolescents aged 11-13 years.

In 49% of cases, the reporting physician identified the COVID-19 pandemic as a precipitating factor in the development of anorexia nervosa. In 37% of cases, the reporting physician identified the pandemic as having precipitated the anorexia-related hospitalization.

Last year, a cross-sectional analysis of children in Canada reported that monthly hospitalizations for anorexia nervosa increased from 7.5 to 20 from March through November 2020. The monthly rate in the CPSP study was closer to 30 for first-time hospitalizations.

Dr. Katzman said that the findings about anorexia nervosa didn’t surprise her. “There was so much disruption and [so many] restrictions to young peoples’ daily routines – closures of schools and recreational activities – they lost regular connection with their peers, and they lost extracurricular and social activities,” she said. “That led to heightened anxiety and depression and really a lack of control.”

Adolescents and teens were also spending more time on social media than they were before the pandemic, she noted. “They were looking at themselves all the time, so they were getting preoccupied with their body image. There was a heightened focus on appearance, and I think that things like public-health mitigation strategies – things like hand washing, social distancing, mask wearing – may have impacted the psychological well-being of young people.”

The closure of outpatient facilities, long waiting lists to get into facilities that were opened, and “coronaphobia” about going to physicians’ offices and emergency departments compounded the problem, Dr. Katzman added.

The long-term effects of COVID and eating disorders in children are unknown, Dr. Katzman said. “This is sort of a wake-up call for the health care system that during times of stress or pandemics or crises, these kinds of things can happen, and we need to be prepared to provide the resources for vulnerable populations moving forward,” she said.
 

Heightened anxiety

Commenting on the data, Margaret Thew, APNP, director of the eating disorders program at Children’s Wisconsin in Milwaukee, said that isolation due to school closures and negative social media messages created the “perfect storm” for eating disorders in adolescents and teenagers because of higher rates of anxiety and depression. Ms. Thew was not involved in the research.

The storm is not over yet, she said. “What everyone needs to keep in mind is that we still have this very heightened state of anxiety and depression ... for adolescents, teenagers, and preteens alike,” Ms. Thew said in an interview, “and we know that many of them are not coping with their anxiety very well.”

In her experience, since the start of the pandemic, the average age of pediatric patients with eating disorders declined from 16 to 15 years, and the youngest age declined from 12 to 11 years.

Overall, the CPSP results show that children are affected by mental health issues at an earlier age than before the pandemic, said Ms. Thew. “Years ago, we wouldn’t have thought that an 8-year-old needed to be screened for some of these risk factors, but now we’re definitely getting more younger children who are struggling, and I think it’s taking too long for them to get the care they need because it’s being overlooked,” she said.

The report was funded by the Public Health Agency of Canada, Health Canada, Alberta Children’s Hospital Research Institute, Bethanys Hope Foundation, CHEO Research Institute, and Children’s Hospital Research Institute of Manitoba. Dr. Katzman and Ms. Thew have no relevant disclosures.

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

The COVID-19 pandemic has been associated with the development of anorexia nervosa in Canadian children and adolescents, data suggest.

Preliminary results of the Canadian Paediatric Surveillance Program (CPSP) indicate that the pandemic has been a precipitating factor in the development of anorexia nervosa in almost half of children and adolescents studied. The pandemic also has precipitated hospitalizations for anorexia in more than one-third of cases.

“Data globally, and certainly our data here in Canada, have shown a real increase in health care utilization with the onset of the COVID-19 pandemic,” study author Debra Katzman, MD, professor of pediatrics at the Hospital for Sick Children in Toronto and the University of Toronto, said in an interview. “And when I talk about health care utilization, I’m talking about hospitalizations for eating disorders.”

The data were included in the 2021 results of the CPSP.
 

Focus on appearance

CPSP is a collaboration between the Public Health Agency of Canada and the Canadian Pediatric Society that consists of a network of 2,800 pediatricians and pediatric subspecialists across Canada. The latest results include surveillance studies on 14 diseases and conditions, with data collected during various periods.

From April 2020 to May 2021, researchers identified 1,800 COVID-19 cases in children and collected detailed information on 1,456 of them, including 405 cases hospitalized with pediatric inflammatory multisystem syndrome (PIMS). The median age of hospitalized cases was 3.2 years for SARS-CoV-2 infection and 5.4 years for PIMS.

Dr. Katzman and colleagues observed 118 first-time hospitalizations for anorexia nervosa between Sept. 1 and Dec. 31, 2021. More than 90% of reported cases were female, with 66% of verified cases in teens aged 14-17 years and the remainder in adolescents aged 11-13 years.

In 49% of cases, the reporting physician identified the COVID-19 pandemic as a precipitating factor in the development of anorexia nervosa. In 37% of cases, the reporting physician identified the pandemic as having precipitated the anorexia-related hospitalization.

Last year, a cross-sectional analysis of children in Canada reported that monthly hospitalizations for anorexia nervosa increased from 7.5 to 20 from March through November 2020. The monthly rate in the CPSP study was closer to 30 for first-time hospitalizations.

Dr. Katzman said that the findings about anorexia nervosa didn’t surprise her. “There was so much disruption and [so many] restrictions to young peoples’ daily routines – closures of schools and recreational activities – they lost regular connection with their peers, and they lost extracurricular and social activities,” she said. “That led to heightened anxiety and depression and really a lack of control.”

Adolescents and teens were also spending more time on social media than they were before the pandemic, she noted. “They were looking at themselves all the time, so they were getting preoccupied with their body image. There was a heightened focus on appearance, and I think that things like public-health mitigation strategies – things like hand washing, social distancing, mask wearing – may have impacted the psychological well-being of young people.”

The closure of outpatient facilities, long waiting lists to get into facilities that were opened, and “coronaphobia” about going to physicians’ offices and emergency departments compounded the problem, Dr. Katzman added.

The long-term effects of COVID and eating disorders in children are unknown, Dr. Katzman said. “This is sort of a wake-up call for the health care system that during times of stress or pandemics or crises, these kinds of things can happen, and we need to be prepared to provide the resources for vulnerable populations moving forward,” she said.
 

Heightened anxiety

Commenting on the data, Margaret Thew, APNP, director of the eating disorders program at Children’s Wisconsin in Milwaukee, said that isolation due to school closures and negative social media messages created the “perfect storm” for eating disorders in adolescents and teenagers because of higher rates of anxiety and depression. Ms. Thew was not involved in the research.

The storm is not over yet, she said. “What everyone needs to keep in mind is that we still have this very heightened state of anxiety and depression ... for adolescents, teenagers, and preteens alike,” Ms. Thew said in an interview, “and we know that many of them are not coping with their anxiety very well.”

In her experience, since the start of the pandemic, the average age of pediatric patients with eating disorders declined from 16 to 15 years, and the youngest age declined from 12 to 11 years.

Overall, the CPSP results show that children are affected by mental health issues at an earlier age than before the pandemic, said Ms. Thew. “Years ago, we wouldn’t have thought that an 8-year-old needed to be screened for some of these risk factors, but now we’re definitely getting more younger children who are struggling, and I think it’s taking too long for them to get the care they need because it’s being overlooked,” she said.

The report was funded by the Public Health Agency of Canada, Health Canada, Alberta Children’s Hospital Research Institute, Bethanys Hope Foundation, CHEO Research Institute, and Children’s Hospital Research Institute of Manitoba. Dr. Katzman and Ms. Thew have no relevant disclosures.

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

The Food and Drug Administration has approved dupilumab for treating adults with prurigo nodularis, the first treatment approved for this indication, according to a press release from the manufacturers.

Recent studies of dupilumab (Dupixent), which inhibits the signaling of the interleukin-4 and IL-13 pathways, show significant improvements in both itchiness and lesion counts, compared with placebo, in adults with prurigo nodularis (PN).

Approval was based on data from two randomized, controlled trials, PRIME and PRIME2, comparing dupilumab with placebo in 311 adults with uncontrolled PN, according to the release issued by Regeneron and Sanofi. Dupilumab is administered via a 300 mg subcutaneous injection every 2 weeks after a loading dose.

The primary endpoint in PRIME and PRIME 2 was a clinically meaningful improvement in itch from baseline as measured by at least a 4-point reduction in the Worst Itch Numeric Rating Scale, a 0-10 scale, at 24 and 12 weeks, respectively. In the studies, 60% and 58% of patients treated with dupilumab met the primary endpoint at 24 weeks, compared with 18% and 20% of those on placebo. At 24 weeks, 48% and 45% of patients on dupilumab achieved clear or almost clear skin, another study endpoint, compared with 18% and 16% among those on placebo.* 

In PRIME and PRIME2, 44% and 37% of patients on dupilumab met the primary endpoint at 12 weeks versus16% and 22% among those on placebo.

Safety profiles were similar to those seen in other dupilumab studies, according to the release. The most common adverse events in the two studies combined were nasopharyngitis, reported in 5% of those on dupilumab versus 2% of those on placebo; conjunctivitis in 4% versus 1%; herpes infection in 3% versus 0; dizziness in 3% vs. 1%; muscle pain in 3% versus 1%; and diarrhea in 3% versus 1%.

Phase 3 data on dupilumab for PN were recently presented at the annual congress of the European Academy of Dermatology and Venereology.

A regulatory submission for dupilumab for treating PN is in progress at the European Medicines Agency, and submissions are planned to regulatory agencies in additional countries later in 2022, according to the company press release.

Dupilumab is currently approved in the United States for atopic dermatitis in children aged 6 months and older and adults with moderate to severe atopic dermatitis and in children and adults aged 6 years and older with moderate to severe eosinophilic or oral steroid-dependent asthma, as well as for the treatment of chronic rhinosinusitis with nasal polyposis in adults, and for the treatment of eosinophilic esophagitis in adults and children aged 12 years and older, weighing at least 40 kg. Dupilumab is under clinical development for the treatment of chronic spontaneous urticaria and bullous pemphigoid, according to the manufacturers.

The studies were supported by Regeneron and Sanofi.

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

*Correction, 9/30/22: An earlier version of this article misstated results of one endpoint. 

The Food and Drug Administration has approved dupilumab for treating adults with prurigo nodularis, the first treatment approved for this indication, according to a press release from the manufacturers.

Recent studies of dupilumab (Dupixent), which inhibits the signaling of the interleukin-4 and IL-13 pathways, show significant improvements in both itchiness and lesion counts, compared with placebo, in adults with prurigo nodularis (PN).

Approval was based on data from two randomized, controlled trials, PRIME and PRIME2, comparing dupilumab with placebo in 311 adults with uncontrolled PN, according to the release issued by Regeneron and Sanofi. Dupilumab is administered via a 300 mg subcutaneous injection every 2 weeks after a loading dose.

The primary endpoint in PRIME and PRIME 2 was a clinically meaningful improvement in itch from baseline as measured by at least a 4-point reduction in the Worst Itch Numeric Rating Scale, a 0-10 scale, at 24 and 12 weeks, respectively. In the studies, 60% and 58% of patients treated with dupilumab met the primary endpoint at 24 weeks, compared with 18% and 20% of those on placebo. At 24 weeks, 48% and 45% of patients on dupilumab achieved clear or almost clear skin, another study endpoint, compared with 18% and 16% among those on placebo.* 

In PRIME and PRIME2, 44% and 37% of patients on dupilumab met the primary endpoint at 12 weeks versus16% and 22% among those on placebo.

Safety profiles were similar to those seen in other dupilumab studies, according to the release. The most common adverse events in the two studies combined were nasopharyngitis, reported in 5% of those on dupilumab versus 2% of those on placebo; conjunctivitis in 4% versus 1%; herpes infection in 3% versus 0; dizziness in 3% vs. 1%; muscle pain in 3% versus 1%; and diarrhea in 3% versus 1%.

Phase 3 data on dupilumab for PN were recently presented at the annual congress of the European Academy of Dermatology and Venereology.

A regulatory submission for dupilumab for treating PN is in progress at the European Medicines Agency, and submissions are planned to regulatory agencies in additional countries later in 2022, according to the company press release.

Dupilumab is currently approved in the United States for atopic dermatitis in children aged 6 months and older and adults with moderate to severe atopic dermatitis and in children and adults aged 6 years and older with moderate to severe eosinophilic or oral steroid-dependent asthma, as well as for the treatment of chronic rhinosinusitis with nasal polyposis in adults, and for the treatment of eosinophilic esophagitis in adults and children aged 12 years and older, weighing at least 40 kg. Dupilumab is under clinical development for the treatment of chronic spontaneous urticaria and bullous pemphigoid, according to the manufacturers.

The studies were supported by Regeneron and Sanofi.

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

*Correction, 9/30/22: An earlier version of this article misstated results of one endpoint. 

The Food and Drug Administration has approved dupilumab for treating adults with prurigo nodularis, the first treatment approved for this indication, according to a press release from the manufacturers.

Recent studies of dupilumab (Dupixent), which inhibits the signaling of the interleukin-4 and IL-13 pathways, show significant improvements in both itchiness and lesion counts, compared with placebo, in adults with prurigo nodularis (PN).

Approval was based on data from two randomized, controlled trials, PRIME and PRIME2, comparing dupilumab with placebo in 311 adults with uncontrolled PN, according to the release issued by Regeneron and Sanofi. Dupilumab is administered via a 300 mg subcutaneous injection every 2 weeks after a loading dose.

The primary endpoint in PRIME and PRIME 2 was a clinically meaningful improvement in itch from baseline as measured by at least a 4-point reduction in the Worst Itch Numeric Rating Scale, a 0-10 scale, at 24 and 12 weeks, respectively. In the studies, 60% and 58% of patients treated with dupilumab met the primary endpoint at 24 weeks, compared with 18% and 20% of those on placebo. At 24 weeks, 48% and 45% of patients on dupilumab achieved clear or almost clear skin, another study endpoint, compared with 18% and 16% among those on placebo.* 

In PRIME and PRIME2, 44% and 37% of patients on dupilumab met the primary endpoint at 12 weeks versus16% and 22% among those on placebo.

Safety profiles were similar to those seen in other dupilumab studies, according to the release. The most common adverse events in the two studies combined were nasopharyngitis, reported in 5% of those on dupilumab versus 2% of those on placebo; conjunctivitis in 4% versus 1%; herpes infection in 3% versus 0; dizziness in 3% vs. 1%; muscle pain in 3% versus 1%; and diarrhea in 3% versus 1%.

Phase 3 data on dupilumab for PN were recently presented at the annual congress of the European Academy of Dermatology and Venereology.

A regulatory submission for dupilumab for treating PN is in progress at the European Medicines Agency, and submissions are planned to regulatory agencies in additional countries later in 2022, according to the company press release.

Dupilumab is currently approved in the United States for atopic dermatitis in children aged 6 months and older and adults with moderate to severe atopic dermatitis and in children and adults aged 6 years and older with moderate to severe eosinophilic or oral steroid-dependent asthma, as well as for the treatment of chronic rhinosinusitis with nasal polyposis in adults, and for the treatment of eosinophilic esophagitis in adults and children aged 12 years and older, weighing at least 40 kg. Dupilumab is under clinical development for the treatment of chronic spontaneous urticaria and bullous pemphigoid, according to the manufacturers.

The studies were supported by Regeneron and Sanofi.

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

*Correction, 9/30/22: An earlier version of this article misstated results of one endpoint. 

People at increased risk for syphilis – including asymptomatic, nonpregnant adolescents and adults who have ever been sexually active and are at high risk for the disease – should be screened for it, according to a reaffirmation by the United States Preventive Services Task Force of its 2016 recommendation of syphilis screening for people at increased risk for infection.

“Using a reaffirmation process, the USPSTF concludes with high certainty that there is a substantial net benefit of screening for syphilis infection in nonpregnant persons who are at increased risk for infection,” the authors, led by Carol M. Mangione, MD, MSPH, of the University of California, Los Angeles, wrote in JAMA.

Reported cases in the United States of primary and secondary syphilis – a sexually transmitted infection caused by the bacterium Treponema pallidum that can damage the brain, nerves, eyes, and cardiovascular system if left untreated – increased from a low of 2.1 cases per 100,000 people in 2000 and 2001 to 11.9 cases per 100,000 in 2019, the authors reported. In 2019, men accounted for 83% of all primary and secondary syphilis cases, and men who have sex with men (MSM) accounted for 57% of all primary and secondary syphilis cases in men. Screening and follow-up treatment can cure syphilis and prevent complications.

To help them evaluate the effectiveness and safety of screening, the USPSTF authors reviewed the literature and visually displayed key questions and linkages to interventions and outcomes, Michelle L. Henninger, PhD, Sarah I. Bean, MPH, and Jennifer S. Lin, MD, MCR, of the Kaiser Permanente Evidence-based Practice Center in Portland, Ore., noted in a related evidence report of the post-2016 recommendation data.

Reaffirming its 2016 recommendation, the USPSTF now advises clinicians to:

Assess risk:

• Clinicians should know how common syphilis is in their community and assess their patient’s individual risk.
• Risk for syphilis is higher in MSM, people with HIV infection or other STIs, and those who use illicit drugs or have a history of incarceration, sex work, or military service.

Screen and confirm by testing:

• Traditional screening algorithm: Start with a nontreponemal test such as Venereal Disease Research Laborator or rapid plasma reagin. If positive, confirm result with a treponemal antibody detection test, such as T. pallidum particle agglutination.
• Reverse sequence algorithm: Screen with an initial automated treponemal test such as enzyme-linked or chemiluminescence immunoassay. If positive, confirm result with a nontreponemal test.

Consider screening interval:

• Evidence on optimal screening intervals is limited for the general population, but MSM and people with HIV may benefit from screening yearly or every 3-6 months if they remain at high risk.

The authors acknowledged that primary and secondary syphilis rates are higher in Blacks, Hispanics, Native Americans/Alaska Native, and Native Hawaiians/Pacific Islanders, and that the disparities are primarily driven by social determinants of health including differences in income, education, and access to coverage and care.

They added that differences in sexual networks also play a role in disparities and that sexually active people in communities with higher STI rates may be more likely to become infected.
 

More testing, treatment, and research are needed

Four experts welcomed the reaffirmation.

“It is important and necessary that the task force has chosen to reaffirm their syphilis screening recommendations, given the continued increase in sexually transmitted infections in the U.S. since the 2016 published recommendations,” Judith A. O’Donnell, MD, director of the department of infection prevention and control at Penn Presbyterian Medical Center in Philadelphia, said in an interview.

“Awareness of the ongoing incidence, understanding of the importance of screening in interrupting transmission, and getting people diagnosed and treated before serious complications are key,” she added.

Heidi Gullettt, MD, MPH, associate director of the Center for Community Health Integration at Case Western Reserve University, Cleveland, said: “The reaffirmation document authors demonstrated a comprehensive review of high-quality studies and epidemiologic data.

“Primary care clinicians rely on USPSTF recommendations to help prioritize evidence-based prevention in practice, so this reaffirmation is a critical step to remind us of the importance of regularly assessing risk and screening with a readily available screening test in the office,” she added.

Testing during office visits is not easy, Dr. Gullettt said, because of competing priorities, stigma associated with STIs, and testing and treatment costs. 

“Under the Affordable Care Act, USPSTF screening recommendations are supposed to be covered without cost sharing by patients. This should be the case for syphilis screening,” Dr. Gullett pointed out. “Patients are often reluctant to do screening because of cost.”

Michael Anthony Moody, MD, director of the Collaborative Influenza Vaccine Innovation Center at Duke University, Durham, N.C., said that the true incidence and prevalence of syphilis is unknown.

“The more we test, the more accurate our data will be,” he said. “Syphilis can hide in plain sight, has symptoms that mimic many other diseases, and is usually not diagnosed. Reaffirming that testing for syphilis is important reminds providers that this is a key test for their patient’s health.”

Aniruddha Hazra, MD, medical director of the University of Chicago Medicine Sexual Wellness Clinic, noted that the United States is in a syphilis epidemic.

“Screening asymptomatic people at risk for syphilis is important, but without comprehensive education and training of primary care providers on how to address STIs and sexual health, these recommendations fall flat,” he said.

In an accompanying editorial, Susan Tuddenham, MD, MPH; and Khalil G. Ghanem, MD, PhD, of Johns Hopkins University, Baltimore, urged that funding to develop novel syphilis diagnostics be prioritized, “just as there has been for development of syphilis vaccines, which are still many years from becoming a reality.”

“Relying on emerging biomedical prevention interventions that hold promise, such as doxycycline postexposure prophylaxis, without concomitant robust screening strategies will not lead to syphilis control. Failure to modernize screening strategies for syphilis will also mean failure to control this infection,” they cautioned.

The authors of the recommendation statement and the evidence report, as well as Dr. O’Donnell, Dr. Gullettt, Dr. Moody, and Dr. Hazra, who were not involved in the study, reported no relevant financial relationships. Dr. Tuddenham reported financial relationships with the pharmaceutical and publishing industries. Dr. Ghanem reported financial relationships with the publishing industry. The research was federally funded.

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

People at increased risk for syphilis – including asymptomatic, nonpregnant adolescents and adults who have ever been sexually active and are at high risk for the disease – should be screened for it, according to a reaffirmation by the United States Preventive Services Task Force of its 2016 recommendation of syphilis screening for people at increased risk for infection.

“Using a reaffirmation process, the USPSTF concludes with high certainty that there is a substantial net benefit of screening for syphilis infection in nonpregnant persons who are at increased risk for infection,” the authors, led by Carol M. Mangione, MD, MSPH, of the University of California, Los Angeles, wrote in JAMA.

Reported cases in the United States of primary and secondary syphilis – a sexually transmitted infection caused by the bacterium Treponema pallidum that can damage the brain, nerves, eyes, and cardiovascular system if left untreated – increased from a low of 2.1 cases per 100,000 people in 2000 and 2001 to 11.9 cases per 100,000 in 2019, the authors reported. In 2019, men accounted for 83% of all primary and secondary syphilis cases, and men who have sex with men (MSM) accounted for 57% of all primary and secondary syphilis cases in men. Screening and follow-up treatment can cure syphilis and prevent complications.

To help them evaluate the effectiveness and safety of screening, the USPSTF authors reviewed the literature and visually displayed key questions and linkages to interventions and outcomes, Michelle L. Henninger, PhD, Sarah I. Bean, MPH, and Jennifer S. Lin, MD, MCR, of the Kaiser Permanente Evidence-based Practice Center in Portland, Ore., noted in a related evidence report of the post-2016 recommendation data.

Reaffirming its 2016 recommendation, the USPSTF now advises clinicians to:

Assess risk:

• Clinicians should know how common syphilis is in their community and assess their patient’s individual risk.
• Risk for syphilis is higher in MSM, people with HIV infection or other STIs, and those who use illicit drugs or have a history of incarceration, sex work, or military service.

Screen and confirm by testing:

• Traditional screening algorithm: Start with a nontreponemal test such as Venereal Disease Research Laborator or rapid plasma reagin. If positive, confirm result with a treponemal antibody detection test, such as T. pallidum particle agglutination.
• Reverse sequence algorithm: Screen with an initial automated treponemal test such as enzyme-linked or chemiluminescence immunoassay. If positive, confirm result with a nontreponemal test.

Consider screening interval:

• Evidence on optimal screening intervals is limited for the general population, but MSM and people with HIV may benefit from screening yearly or every 3-6 months if they remain at high risk.

The authors acknowledged that primary and secondary syphilis rates are higher in Blacks, Hispanics, Native Americans/Alaska Native, and Native Hawaiians/Pacific Islanders, and that the disparities are primarily driven by social determinants of health including differences in income, education, and access to coverage and care.

They added that differences in sexual networks also play a role in disparities and that sexually active people in communities with higher STI rates may be more likely to become infected.
 

More testing, treatment, and research are needed

Four experts welcomed the reaffirmation.

“It is important and necessary that the task force has chosen to reaffirm their syphilis screening recommendations, given the continued increase in sexually transmitted infections in the U.S. since the 2016 published recommendations,” Judith A. O’Donnell, MD, director of the department of infection prevention and control at Penn Presbyterian Medical Center in Philadelphia, said in an interview.

“Awareness of the ongoing incidence, understanding of the importance of screening in interrupting transmission, and getting people diagnosed and treated before serious complications are key,” she added.

Heidi Gullettt, MD, MPH, associate director of the Center for Community Health Integration at Case Western Reserve University, Cleveland, said: “The reaffirmation document authors demonstrated a comprehensive review of high-quality studies and epidemiologic data.

“Primary care clinicians rely on USPSTF recommendations to help prioritize evidence-based prevention in practice, so this reaffirmation is a critical step to remind us of the importance of regularly assessing risk and screening with a readily available screening test in the office,” she added.

Testing during office visits is not easy, Dr. Gullettt said, because of competing priorities, stigma associated with STIs, and testing and treatment costs. 

“Under the Affordable Care Act, USPSTF screening recommendations are supposed to be covered without cost sharing by patients. This should be the case for syphilis screening,” Dr. Gullett pointed out. “Patients are often reluctant to do screening because of cost.”

Michael Anthony Moody, MD, director of the Collaborative Influenza Vaccine Innovation Center at Duke University, Durham, N.C., said that the true incidence and prevalence of syphilis is unknown.

“The more we test, the more accurate our data will be,” he said. “Syphilis can hide in plain sight, has symptoms that mimic many other diseases, and is usually not diagnosed. Reaffirming that testing for syphilis is important reminds providers that this is a key test for their patient’s health.”

Aniruddha Hazra, MD, medical director of the University of Chicago Medicine Sexual Wellness Clinic, noted that the United States is in a syphilis epidemic.

“Screening asymptomatic people at risk for syphilis is important, but without comprehensive education and training of primary care providers on how to address STIs and sexual health, these recommendations fall flat,” he said.

In an accompanying editorial, Susan Tuddenham, MD, MPH; and Khalil G. Ghanem, MD, PhD, of Johns Hopkins University, Baltimore, urged that funding to develop novel syphilis diagnostics be prioritized, “just as there has been for development of syphilis vaccines, which are still many years from becoming a reality.”

“Relying on emerging biomedical prevention interventions that hold promise, such as doxycycline postexposure prophylaxis, without concomitant robust screening strategies will not lead to syphilis control. Failure to modernize screening strategies for syphilis will also mean failure to control this infection,” they cautioned.

The authors of the recommendation statement and the evidence report, as well as Dr. O’Donnell, Dr. Gullettt, Dr. Moody, and Dr. Hazra, who were not involved in the study, reported no relevant financial relationships. Dr. Tuddenham reported financial relationships with the pharmaceutical and publishing industries. Dr. Ghanem reported financial relationships with the publishing industry. The research was federally funded.

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

People at increased risk for syphilis – including asymptomatic, nonpregnant adolescents and adults who have ever been sexually active and are at high risk for the disease – should be screened for it, according to a reaffirmation by the United States Preventive Services Task Force of its 2016 recommendation of syphilis screening for people at increased risk for infection.

“Using a reaffirmation process, the USPSTF concludes with high certainty that there is a substantial net benefit of screening for syphilis infection in nonpregnant persons who are at increased risk for infection,” the authors, led by Carol M. Mangione, MD, MSPH, of the University of California, Los Angeles, wrote in JAMA.

Reported cases in the United States of primary and secondary syphilis – a sexually transmitted infection caused by the bacterium Treponema pallidum that can damage the brain, nerves, eyes, and cardiovascular system if left untreated – increased from a low of 2.1 cases per 100,000 people in 2000 and 2001 to 11.9 cases per 100,000 in 2019, the authors reported. In 2019, men accounted for 83% of all primary and secondary syphilis cases, and men who have sex with men (MSM) accounted for 57% of all primary and secondary syphilis cases in men. Screening and follow-up treatment can cure syphilis and prevent complications.

To help them evaluate the effectiveness and safety of screening, the USPSTF authors reviewed the literature and visually displayed key questions and linkages to interventions and outcomes, Michelle L. Henninger, PhD, Sarah I. Bean, MPH, and Jennifer S. Lin, MD, MCR, of the Kaiser Permanente Evidence-based Practice Center in Portland, Ore., noted in a related evidence report of the post-2016 recommendation data.

Reaffirming its 2016 recommendation, the USPSTF now advises clinicians to:

Assess risk:

• Clinicians should know how common syphilis is in their community and assess their patient’s individual risk.
• Risk for syphilis is higher in MSM, people with HIV infection or other STIs, and those who use illicit drugs or have a history of incarceration, sex work, or military service.

Screen and confirm by testing:

• Traditional screening algorithm: Start with a nontreponemal test such as Venereal Disease Research Laborator or rapid plasma reagin. If positive, confirm result with a treponemal antibody detection test, such as T. pallidum particle agglutination.
• Reverse sequence algorithm: Screen with an initial automated treponemal test such as enzyme-linked or chemiluminescence immunoassay. If positive, confirm result with a nontreponemal test.

Consider screening interval:

• Evidence on optimal screening intervals is limited for the general population, but MSM and people with HIV may benefit from screening yearly or every 3-6 months if they remain at high risk.

The authors acknowledged that primary and secondary syphilis rates are higher in Blacks, Hispanics, Native Americans/Alaska Native, and Native Hawaiians/Pacific Islanders, and that the disparities are primarily driven by social determinants of health including differences in income, education, and access to coverage and care.

They added that differences in sexual networks also play a role in disparities and that sexually active people in communities with higher STI rates may be more likely to become infected.
 

More testing, treatment, and research are needed

Four experts welcomed the reaffirmation.

“It is important and necessary that the task force has chosen to reaffirm their syphilis screening recommendations, given the continued increase in sexually transmitted infections in the U.S. since the 2016 published recommendations,” Judith A. O’Donnell, MD, director of the department of infection prevention and control at Penn Presbyterian Medical Center in Philadelphia, said in an interview.

“Awareness of the ongoing incidence, understanding of the importance of screening in interrupting transmission, and getting people diagnosed and treated before serious complications are key,” she added.

Heidi Gullettt, MD, MPH, associate director of the Center for Community Health Integration at Case Western Reserve University, Cleveland, said: “The reaffirmation document authors demonstrated a comprehensive review of high-quality studies and epidemiologic data.

“Primary care clinicians rely on USPSTF recommendations to help prioritize evidence-based prevention in practice, so this reaffirmation is a critical step to remind us of the importance of regularly assessing risk and screening with a readily available screening test in the office,” she added.

Testing during office visits is not easy, Dr. Gullettt said, because of competing priorities, stigma associated with STIs, and testing and treatment costs. 

“Under the Affordable Care Act, USPSTF screening recommendations are supposed to be covered without cost sharing by patients. This should be the case for syphilis screening,” Dr. Gullett pointed out. “Patients are often reluctant to do screening because of cost.”

Michael Anthony Moody, MD, director of the Collaborative Influenza Vaccine Innovation Center at Duke University, Durham, N.C., said that the true incidence and prevalence of syphilis is unknown.

“The more we test, the more accurate our data will be,” he said. “Syphilis can hide in plain sight, has symptoms that mimic many other diseases, and is usually not diagnosed. Reaffirming that testing for syphilis is important reminds providers that this is a key test for their patient’s health.”

Aniruddha Hazra, MD, medical director of the University of Chicago Medicine Sexual Wellness Clinic, noted that the United States is in a syphilis epidemic.

“Screening asymptomatic people at risk for syphilis is important, but without comprehensive education and training of primary care providers on how to address STIs and sexual health, these recommendations fall flat,” he said.

In an accompanying editorial, Susan Tuddenham, MD, MPH; and Khalil G. Ghanem, MD, PhD, of Johns Hopkins University, Baltimore, urged that funding to develop novel syphilis diagnostics be prioritized, “just as there has been for development of syphilis vaccines, which are still many years from becoming a reality.”

“Relying on emerging biomedical prevention interventions that hold promise, such as doxycycline postexposure prophylaxis, without concomitant robust screening strategies will not lead to syphilis control. Failure to modernize screening strategies for syphilis will also mean failure to control this infection,” they cautioned.

The authors of the recommendation statement and the evidence report, as well as Dr. O’Donnell, Dr. Gullettt, Dr. Moody, and Dr. Hazra, who were not involved in the study, reported no relevant financial relationships. Dr. Tuddenham reported financial relationships with the pharmaceutical and publishing industries. Dr. Ghanem reported financial relationships with the publishing industry. The research was federally funded.

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

When counseling patients with acne about a treatment plan, consider the mnemonic “CLEAR,” advises Julie C. Harper, MD, who came up with this aid to use when treating this group of patients.

During a presentation at Medscape Live’s annual Coastal Dermatology Symposium, Dr. Harper, who practices at Dermatology and Skin Care of Birmingham, Ala., elaborated on the mnemonic, as follows:

C: Communicate expectations. “I look right at the acne patient and say, ‘I know you don’t just want to be better; I know you want to be clear,’ ” she said at the meeting. “ ‘That’s my goal for you, too. That may take us more than one visit and more than one treatment, but I am on your team, and that’s what we’re shooting for.’ If you don’t communicate that, they’re going to think that their acne is not that important to you.”

L: Listen for clues to customize the patient’s treatment. “We’re quick to say, ‘my patients don’t do what I recommend,’ or ‘they didn’t do what the last doctor recommended,’ ” Dr. Harper said. “Sometimes that is true, but there may be a reason why. Maybe the medication was too expensive. Maybe it was bleaching their fabrics. Maybe the regimen was too complex. Listen for opportunities to make adjustments to get their acne closer to clear.”

E: Treat early to improve quality of life and to decrease the risk of scarring. “I have a laser in my practice that is good at treating acne scarring,” she said. “Do I ever look at my patient and say, ‘don’t worry about those scars; I can make them go away?’ No. I look at them and say, ‘we can maybe make this 40% better,’ something like that. We have to prevent acne scars, because we’re not good at treating them.”

A: Treat aggressively with more combination therapies, more hormonal therapies, more isotretinoin, and perhaps more prior authorizations. She characterized the effort to obtain a prior authorization as “our megaphone back to insurance companies that says, ‘we think it is worth taking the time to do this prior authorization because the acne patient will benefit.’ ”

R: Don’t resist isotretinoin. Dr. Harper, who began practicing dermatology more than 20 years ago, said that over time, she has gradually prescribed more isotretinoin for her patients with acne. “It’s not a first-line [treatment], but I’m not afraid of it. If I can’t get somebody clear on other oral or topical treatments, we are going to try isotretinoin.”

The goal of acne treatment, she added, is to affect four key aspects of pathogenesis: follicular epithelial hyperproliferation, inflammation, Cutibacterium acnes (C. acnes), and sebum. “That’s what we’re always shooting for,” she said.

Dr. Harper is a past president of the American Acne & Rosacea Society. She disclosed that she serves as an advisor or consultant for Almirall, BioPharmX, Cassiopeia, Cutanea, Cutera, Dermira, EPI, Galderma, LaRoche-Posay, Ortho, Vyne, Sol Gel, and Sun. She also serves as a speaker or member of a speaker’s bureau for Almirall, EPI, Galderma, Ortho, and Vyne.

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

When counseling patients with acne about a treatment plan, consider the mnemonic “CLEAR,” advises Julie C. Harper, MD, who came up with this aid to use when treating this group of patients.

During a presentation at Medscape Live’s annual Coastal Dermatology Symposium, Dr. Harper, who practices at Dermatology and Skin Care of Birmingham, Ala., elaborated on the mnemonic, as follows:

C: Communicate expectations. “I look right at the acne patient and say, ‘I know you don’t just want to be better; I know you want to be clear,’ ” she said at the meeting. “ ‘That’s my goal for you, too. That may take us more than one visit and more than one treatment, but I am on your team, and that’s what we’re shooting for.’ If you don’t communicate that, they’re going to think that their acne is not that important to you.”

L: Listen for clues to customize the patient’s treatment. “We’re quick to say, ‘my patients don’t do what I recommend,’ or ‘they didn’t do what the last doctor recommended,’ ” Dr. Harper said. “Sometimes that is true, but there may be a reason why. Maybe the medication was too expensive. Maybe it was bleaching their fabrics. Maybe the regimen was too complex. Listen for opportunities to make adjustments to get their acne closer to clear.”

E: Treat early to improve quality of life and to decrease the risk of scarring. “I have a laser in my practice that is good at treating acne scarring,” she said. “Do I ever look at my patient and say, ‘don’t worry about those scars; I can make them go away?’ No. I look at them and say, ‘we can maybe make this 40% better,’ something like that. We have to prevent acne scars, because we’re not good at treating them.”

A: Treat aggressively with more combination therapies, more hormonal therapies, more isotretinoin, and perhaps more prior authorizations. She characterized the effort to obtain a prior authorization as “our megaphone back to insurance companies that says, ‘we think it is worth taking the time to do this prior authorization because the acne patient will benefit.’ ”

R: Don’t resist isotretinoin. Dr. Harper, who began practicing dermatology more than 20 years ago, said that over time, she has gradually prescribed more isotretinoin for her patients with acne. “It’s not a first-line [treatment], but I’m not afraid of it. If I can’t get somebody clear on other oral or topical treatments, we are going to try isotretinoin.”

The goal of acne treatment, she added, is to affect four key aspects of pathogenesis: follicular epithelial hyperproliferation, inflammation, Cutibacterium acnes (C. acnes), and sebum. “That’s what we’re always shooting for,” she said.

Dr. Harper is a past president of the American Acne & Rosacea Society. She disclosed that she serves as an advisor or consultant for Almirall, BioPharmX, Cassiopeia, Cutanea, Cutera, Dermira, EPI, Galderma, LaRoche-Posay, Ortho, Vyne, Sol Gel, and Sun. She also serves as a speaker or member of a speaker’s bureau for Almirall, EPI, Galderma, Ortho, and Vyne.

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

When counseling patients with acne about a treatment plan, consider the mnemonic “CLEAR,” advises Julie C. Harper, MD, who came up with this aid to use when treating this group of patients.

During a presentation at Medscape Live’s annual Coastal Dermatology Symposium, Dr. Harper, who practices at Dermatology and Skin Care of Birmingham, Ala., elaborated on the mnemonic, as follows:

C: Communicate expectations. “I look right at the acne patient and say, ‘I know you don’t just want to be better; I know you want to be clear,’ ” she said at the meeting. “ ‘That’s my goal for you, too. That may take us more than one visit and more than one treatment, but I am on your team, and that’s what we’re shooting for.’ If you don’t communicate that, they’re going to think that their acne is not that important to you.”

L: Listen for clues to customize the patient’s treatment. “We’re quick to say, ‘my patients don’t do what I recommend,’ or ‘they didn’t do what the last doctor recommended,’ ” Dr. Harper said. “Sometimes that is true, but there may be a reason why. Maybe the medication was too expensive. Maybe it was bleaching their fabrics. Maybe the regimen was too complex. Listen for opportunities to make adjustments to get their acne closer to clear.”

E: Treat early to improve quality of life and to decrease the risk of scarring. “I have a laser in my practice that is good at treating acne scarring,” she said. “Do I ever look at my patient and say, ‘don’t worry about those scars; I can make them go away?’ No. I look at them and say, ‘we can maybe make this 40% better,’ something like that. We have to prevent acne scars, because we’re not good at treating them.”

A: Treat aggressively with more combination therapies, more hormonal therapies, more isotretinoin, and perhaps more prior authorizations. She characterized the effort to obtain a prior authorization as “our megaphone back to insurance companies that says, ‘we think it is worth taking the time to do this prior authorization because the acne patient will benefit.’ ”

R: Don’t resist isotretinoin. Dr. Harper, who began practicing dermatology more than 20 years ago, said that over time, she has gradually prescribed more isotretinoin for her patients with acne. “It’s not a first-line [treatment], but I’m not afraid of it. If I can’t get somebody clear on other oral or topical treatments, we are going to try isotretinoin.”

The goal of acne treatment, she added, is to affect four key aspects of pathogenesis: follicular epithelial hyperproliferation, inflammation, Cutibacterium acnes (C. acnes), and sebum. “That’s what we’re always shooting for,” she said.

Dr. Harper is a past president of the American Acne & Rosacea Society. She disclosed that she serves as an advisor or consultant for Almirall, BioPharmX, Cassiopeia, Cutanea, Cutera, Dermira, EPI, Galderma, LaRoche-Posay, Ortho, Vyne, Sol Gel, and Sun. She also serves as a speaker or member of a speaker’s bureau for Almirall, EPI, Galderma, Ortho, and Vyne.

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

Despite a higher symptom burden, patients with major depressive disorder (MDD) and a history of childhood trauma (CT) can achieve significant recovery following treatment with a combination of pharmacotherapy and psychotherapy, new research suggests.
 

Results from a meta-analysis of 29 studies from 1966 to 2019, which included almost 7,000 adults with MDD, showed that more than 60% reported a history of CT. But despite having more severe depression at baseline, those with CT benefited from active treatment. Effect sizes were comparable, and dropout rates were similar to those of their counterparts without CT.

“Evidence-based psychotherapy and pharmacotherapy should be offered to depressed patients, regardless of their childhood trauma status,” lead author Erika Kuzminskaite, MSc, a PhD candidate at Amsterdam UMC department of psychiatry, the Netherlands, told this news organization.

“Screening for childhood trauma is important to identify individuals at risk for more severe course of the disorder and post-treatment residual symptoms,” she added.

The study was published online in the Lancet Psychiatry.
 

Common and potent risk factor

The researchers note that CT is common and is a potent risk factor for depression. Previous studies have “consistently indicated significantly higher severity and persistence of depressive symptoms in adult patients with depression and a history of childhood trauma.”

Previous individual and meta-analytic studies “indicated poorer response to first-line depression treatments in patients with childhood trauma, compared to those without trauma, suggesting the need for new personalized treatments for depressed patients with childhood trauma history,” Ms. Kuzminskaite said.

“However, the evidence on poorer treatment outcomes has not been definitive, and a comprehensive meta-analysis of available findings has been lacking,” she added.

The previous meta-analyses showed high between-study heterogeneity, and some primary studies reported similar or even superior improvement for patients with CT, compared with those without such history, following treatment with evidence-based psychotherapy or pharmacotherapy.

Previous studies also did not investigate the “relative contribution of different childhood trauma types.”

To address this gap, investigators in the Childhood Trauma Meta-Analysis Study Group conducted the “largest and most comprehensive study of available evidence examining the effects of childhood trauma on the efficacy and effectiveness of first-line treatments for adults with MDD.”

To be included, a study had to focus on adults over 18 years old who had received a primary diagnosis of depression. The study had to have included an available assessment of childhood trauma, and patients were required to have undergone psychotherapy and/or pharmacotherapy for depression alone or in combination with other guideline-recommended treatments. Studies were also required to have a comparator group, when applicable, and to have reported depression severity before and after the acute treatment phase.

Of 10,505 publications, 54 trials met inclusion criteria; of these, 29 (20 randomized controlled trials and 9 open trials), encompassing 6,830 participants aged 18-85 years, included data that had been made available by authors of the various studies and were included in the current analysis.

Most studies focused on MDD; 11 trials focused on patients with chronic or treatment-resistant depression.

The primary outcome was “depression severity change from baseline to the end of the acute treatment phase” (expressed as standardized effect size – Hedges’ g).
 

Greater treatment motivation?

Of the included patients, 62% reported a history of CT. They were found to have more severe depression at baseline, compared with those without CT (g = .202; 95% confidence interval, 0.145-0.258; I² = 0%).

The benefits from active treatment obtained by these patients with CT were similar to the benefits obtained by their counterparts without CT (between-group treatment effect difference: g = .016; 95% CI, –0.094-0.125; I² = 44.3%).

No significant difference in active treatment effects (in comparison with control condition) was found between individuals with and those without CT (g = .605; 95% CI, 0.294-0.916; I² = 58.0%; and g = .178; 95% CI, –0.195-0.552; I² = 67.5%, respectively; between-group difference P = .051).

Dropout rates were similar for the participants with and those without CT (risk ratio, 1.063; 95% CI, 0.945-1.195; I² = 0%).

“Findings did not significantly differ by childhood trauma type, study design, depression diagnosis, assessment method of childhood trauma, study quality, year, or treatment type or length,” the authors report.

The findings did, however, differ by country, with North American studies showing larger treatment effects for patients with CT, compared with studies conducted in Asian-Pacific countries (g = 0.150; 95% CI, 0.030-0.269; vs. g = 0.255; 95% CI, –0.508- –0.002, respectively; corrected false discovery rate, 0.0080). “However, because of limited power, these findings should be interpreted with caution,” the authors warn.

“It could be a chance finding and is certainly not causal,” Ms. Kuzminskaite suggested.

Most studies (21 of the 29) had a “moderate to high risk of bias.” But when the researchers conducted a sensitivity analysis in the low-bias studies, they found that results were similar to those of the primary analysis that included all the studies.

“Treatments were similarly effective for patients with and without childhood trauma, with slightly larger active treatment (vs. control condition – placebo, wait list, care-as-usual) effects for patients with childhood trauma history,” Ms. Kuzminskaite said.

“Some evidence suggests that patients with childhood trauma are characterized by greater treatment motivation,” she noted. Moreover, “they are also more severely depressed prior to treatment [and] thus have more room for improvement.”
 

‘Hopeful message’

Commenting for this news organization, Yvette Sheline, MD, McLure professor of psychiatry, radiology, and neurology and director of the center for neuromodulation in depression and Stress, University of Pennsylvania, Philadelphia, called it a “well-executed” and “straightforward” study “with clear-cut findings.”

Dr. Sheline, the director of the section on mood, anxiety, and trauma, who was not involved with the study, agrees with the authors’ conclusions – “to use evidence-based treatments for depression in all patients,” with or without a history of CT.

In an accompanying editorial, Antoine Yrondi, MD, PhD, of Université de Toulouse (France), called the findings “important and encouraging” but cautioned that CT could be associated with conditions other than depression, which could make MDD “more difficult to treat.”

Nevertheless, the meta-analysis “delivers a hopeful message to patients with childhood trauma that evidence-based psychotherapy and pharmacotherapy could improve depressive symptoms,” Dr. Yrondi said.

Dr. Yrondi encouraged physicians not to neglect CT in patients with MDD. “For this, it is important that physicians are trained to evaluate childhood trauma and to take it into account in their daily practice.”

No source of funding for the study was listed. The authors and Dr. Sheline have disclosed no relevant financial relationships. Dr. Yrondi has received speaker’s honoraria from AstraZeneca, Janssen, Lundbeck, Otsuka, and Jazz and has carried out clinical studies in relation to the development of a medicine for Janssen and Lundbeck that are unrelated to this work.

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

Despite a higher symptom burden, patients with major depressive disorder (MDD) and a history of childhood trauma (CT) can achieve significant recovery following treatment with a combination of pharmacotherapy and psychotherapy, new research suggests.
 

Results from a meta-analysis of 29 studies from 1966 to 2019, which included almost 7,000 adults with MDD, showed that more than 60% reported a history of CT. But despite having more severe depression at baseline, those with CT benefited from active treatment. Effect sizes were comparable, and dropout rates were similar to those of their counterparts without CT.

“Evidence-based psychotherapy and pharmacotherapy should be offered to depressed patients, regardless of their childhood trauma status,” lead author Erika Kuzminskaite, MSc, a PhD candidate at Amsterdam UMC department of psychiatry, the Netherlands, told this news organization.

“Screening for childhood trauma is important to identify individuals at risk for more severe course of the disorder and post-treatment residual symptoms,” she added.

The study was published online in the Lancet Psychiatry.
 

Common and potent risk factor

The researchers note that CT is common and is a potent risk factor for depression. Previous studies have “consistently indicated significantly higher severity and persistence of depressive symptoms in adult patients with depression and a history of childhood trauma.”

Previous individual and meta-analytic studies “indicated poorer response to first-line depression treatments in patients with childhood trauma, compared to those without trauma, suggesting the need for new personalized treatments for depressed patients with childhood trauma history,” Ms. Kuzminskaite said.

“However, the evidence on poorer treatment outcomes has not been definitive, and a comprehensive meta-analysis of available findings has been lacking,” she added.

The previous meta-analyses showed high between-study heterogeneity, and some primary studies reported similar or even superior improvement for patients with CT, compared with those without such history, following treatment with evidence-based psychotherapy or pharmacotherapy.

Previous studies also did not investigate the “relative contribution of different childhood trauma types.”

To address this gap, investigators in the Childhood Trauma Meta-Analysis Study Group conducted the “largest and most comprehensive study of available evidence examining the effects of childhood trauma on the efficacy and effectiveness of first-line treatments for adults with MDD.”

To be included, a study had to focus on adults over 18 years old who had received a primary diagnosis of depression. The study had to have included an available assessment of childhood trauma, and patients were required to have undergone psychotherapy and/or pharmacotherapy for depression alone or in combination with other guideline-recommended treatments. Studies were also required to have a comparator group, when applicable, and to have reported depression severity before and after the acute treatment phase.

Of 10,505 publications, 54 trials met inclusion criteria; of these, 29 (20 randomized controlled trials and 9 open trials), encompassing 6,830 participants aged 18-85 years, included data that had been made available by authors of the various studies and were included in the current analysis.

Most studies focused on MDD; 11 trials focused on patients with chronic or treatment-resistant depression.

The primary outcome was “depression severity change from baseline to the end of the acute treatment phase” (expressed as standardized effect size – Hedges’ g).
 

Greater treatment motivation?

Of the included patients, 62% reported a history of CT. They were found to have more severe depression at baseline, compared with those without CT (g = .202; 95% confidence interval, 0.145-0.258; I² = 0%).

The benefits from active treatment obtained by these patients with CT were similar to the benefits obtained by their counterparts without CT (between-group treatment effect difference: g = .016; 95% CI, –0.094-0.125; I² = 44.3%).

No significant difference in active treatment effects (in comparison with control condition) was found between individuals with and those without CT (g = .605; 95% CI, 0.294-0.916; I² = 58.0%; and g = .178; 95% CI, –0.195-0.552; I² = 67.5%, respectively; between-group difference P = .051).

Dropout rates were similar for the participants with and those without CT (risk ratio, 1.063; 95% CI, 0.945-1.195; I² = 0%).

“Findings did not significantly differ by childhood trauma type, study design, depression diagnosis, assessment method of childhood trauma, study quality, year, or treatment type or length,” the authors report.

The findings did, however, differ by country, with North American studies showing larger treatment effects for patients with CT, compared with studies conducted in Asian-Pacific countries (g = 0.150; 95% CI, 0.030-0.269; vs. g = 0.255; 95% CI, –0.508- –0.002, respectively; corrected false discovery rate, 0.0080). “However, because of limited power, these findings should be interpreted with caution,” the authors warn.

“It could be a chance finding and is certainly not causal,” Ms. Kuzminskaite suggested.

Most studies (21 of the 29) had a “moderate to high risk of bias.” But when the researchers conducted a sensitivity analysis in the low-bias studies, they found that results were similar to those of the primary analysis that included all the studies.

“Treatments were similarly effective for patients with and without childhood trauma, with slightly larger active treatment (vs. control condition – placebo, wait list, care-as-usual) effects for patients with childhood trauma history,” Ms. Kuzminskaite said.

“Some evidence suggests that patients with childhood trauma are characterized by greater treatment motivation,” she noted. Moreover, “they are also more severely depressed prior to treatment [and] thus have more room for improvement.”
 

‘Hopeful message’

Commenting for this news organization, Yvette Sheline, MD, McLure professor of psychiatry, radiology, and neurology and director of the center for neuromodulation in depression and Stress, University of Pennsylvania, Philadelphia, called it a “well-executed” and “straightforward” study “with clear-cut findings.”

Dr. Sheline, the director of the section on mood, anxiety, and trauma, who was not involved with the study, agrees with the authors’ conclusions – “to use evidence-based treatments for depression in all patients,” with or without a history of CT.

In an accompanying editorial, Antoine Yrondi, MD, PhD, of Université de Toulouse (France), called the findings “important and encouraging” but cautioned that CT could be associated with conditions other than depression, which could make MDD “more difficult to treat.”

Nevertheless, the meta-analysis “delivers a hopeful message to patients with childhood trauma that evidence-based psychotherapy and pharmacotherapy could improve depressive symptoms,” Dr. Yrondi said.

Dr. Yrondi encouraged physicians not to neglect CT in patients with MDD. “For this, it is important that physicians are trained to evaluate childhood trauma and to take it into account in their daily practice.”

No source of funding for the study was listed. The authors and Dr. Sheline have disclosed no relevant financial relationships. Dr. Yrondi has received speaker’s honoraria from AstraZeneca, Janssen, Lundbeck, Otsuka, and Jazz and has carried out clinical studies in relation to the development of a medicine for Janssen and Lundbeck that are unrelated to this work.

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

Despite a higher symptom burden, patients with major depressive disorder (MDD) and a history of childhood trauma (CT) can achieve significant recovery following treatment with a combination of pharmacotherapy and psychotherapy, new research suggests.
 

Results from a meta-analysis of 29 studies from 1966 to 2019, which included almost 7,000 adults with MDD, showed that more than 60% reported a history of CT. But despite having more severe depression at baseline, those with CT benefited from active treatment. Effect sizes were comparable, and dropout rates were similar to those of their counterparts without CT.

“Evidence-based psychotherapy and pharmacotherapy should be offered to depressed patients, regardless of their childhood trauma status,” lead author Erika Kuzminskaite, MSc, a PhD candidate at Amsterdam UMC department of psychiatry, the Netherlands, told this news organization.

“Screening for childhood trauma is important to identify individuals at risk for more severe course of the disorder and post-treatment residual symptoms,” she added.

The study was published online in the Lancet Psychiatry.
 

Common and potent risk factor

The researchers note that CT is common and is a potent risk factor for depression. Previous studies have “consistently indicated significantly higher severity and persistence of depressive symptoms in adult patients with depression and a history of childhood trauma.”

Previous individual and meta-analytic studies “indicated poorer response to first-line depression treatments in patients with childhood trauma, compared to those without trauma, suggesting the need for new personalized treatments for depressed patients with childhood trauma history,” Ms. Kuzminskaite said.

“However, the evidence on poorer treatment outcomes has not been definitive, and a comprehensive meta-analysis of available findings has been lacking,” she added.

The previous meta-analyses showed high between-study heterogeneity, and some primary studies reported similar or even superior improvement for patients with CT, compared with those without such history, following treatment with evidence-based psychotherapy or pharmacotherapy.

Previous studies also did not investigate the “relative contribution of different childhood trauma types.”

To address this gap, investigators in the Childhood Trauma Meta-Analysis Study Group conducted the “largest and most comprehensive study of available evidence examining the effects of childhood trauma on the efficacy and effectiveness of first-line treatments for adults with MDD.”

To be included, a study had to focus on adults over 18 years old who had received a primary diagnosis of depression. The study had to have included an available assessment of childhood trauma, and patients were required to have undergone psychotherapy and/or pharmacotherapy for depression alone or in combination with other guideline-recommended treatments. Studies were also required to have a comparator group, when applicable, and to have reported depression severity before and after the acute treatment phase.

Of 10,505 publications, 54 trials met inclusion criteria; of these, 29 (20 randomized controlled trials and 9 open trials), encompassing 6,830 participants aged 18-85 years, included data that had been made available by authors of the various studies and were included in the current analysis.

Most studies focused on MDD; 11 trials focused on patients with chronic or treatment-resistant depression.

The primary outcome was “depression severity change from baseline to the end of the acute treatment phase” (expressed as standardized effect size – Hedges’ g).
 

Greater treatment motivation?

Of the included patients, 62% reported a history of CT. They were found to have more severe depression at baseline, compared with those without CT (g = .202; 95% confidence interval, 0.145-0.258; I² = 0%).

The benefits from active treatment obtained by these patients with CT were similar to the benefits obtained by their counterparts without CT (between-group treatment effect difference: g = .016; 95% CI, –0.094-0.125; I² = 44.3%).

No significant difference in active treatment effects (in comparison with control condition) was found between individuals with and those without CT (g = .605; 95% CI, 0.294-0.916; I² = 58.0%; and g = .178; 95% CI, –0.195-0.552; I² = 67.5%, respectively; between-group difference P = .051).

Dropout rates were similar for the participants with and those without CT (risk ratio, 1.063; 95% CI, 0.945-1.195; I² = 0%).

“Findings did not significantly differ by childhood trauma type, study design, depression diagnosis, assessment method of childhood trauma, study quality, year, or treatment type or length,” the authors report.

The findings did, however, differ by country, with North American studies showing larger treatment effects for patients with CT, compared with studies conducted in Asian-Pacific countries (g = 0.150; 95% CI, 0.030-0.269; vs. g = 0.255; 95% CI, –0.508- –0.002, respectively; corrected false discovery rate, 0.0080). “However, because of limited power, these findings should be interpreted with caution,” the authors warn.

“It could be a chance finding and is certainly not causal,” Ms. Kuzminskaite suggested.

Most studies (21 of the 29) had a “moderate to high risk of bias.” But when the researchers conducted a sensitivity analysis in the low-bias studies, they found that results were similar to those of the primary analysis that included all the studies.

“Treatments were similarly effective for patients with and without childhood trauma, with slightly larger active treatment (vs. control condition – placebo, wait list, care-as-usual) effects for patients with childhood trauma history,” Ms. Kuzminskaite said.

“Some evidence suggests that patients with childhood trauma are characterized by greater treatment motivation,” she noted. Moreover, “they are also more severely depressed prior to treatment [and] thus have more room for improvement.”
 

‘Hopeful message’

Commenting for this news organization, Yvette Sheline, MD, McLure professor of psychiatry, radiology, and neurology and director of the center for neuromodulation in depression and Stress, University of Pennsylvania, Philadelphia, called it a “well-executed” and “straightforward” study “with clear-cut findings.”

Dr. Sheline, the director of the section on mood, anxiety, and trauma, who was not involved with the study, agrees with the authors’ conclusions – “to use evidence-based treatments for depression in all patients,” with or without a history of CT.

In an accompanying editorial, Antoine Yrondi, MD, PhD, of Université de Toulouse (France), called the findings “important and encouraging” but cautioned that CT could be associated with conditions other than depression, which could make MDD “more difficult to treat.”

Nevertheless, the meta-analysis “delivers a hopeful message to patients with childhood trauma that evidence-based psychotherapy and pharmacotherapy could improve depressive symptoms,” Dr. Yrondi said.

Dr. Yrondi encouraged physicians not to neglect CT in patients with MDD. “For this, it is important that physicians are trained to evaluate childhood trauma and to take it into account in their daily practice.”

No source of funding for the study was listed. The authors and Dr. Sheline have disclosed no relevant financial relationships. Dr. Yrondi has received speaker’s honoraria from AstraZeneca, Janssen, Lundbeck, Otsuka, and Jazz and has carried out clinical studies in relation to the development of a medicine for Janssen and Lundbeck that are unrelated to this work.

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

An athletic coach stands in front of a packed gym full of high school students.
 

“Don’t have sex,” he instructs, “because you will get pregnant and die. Don’t have sex in the missionary position. Don’t have sex standing up. Just don’t do it, promise? Okay, everybody take some rubbers.”

Sad to say, this scene from the 2004 movie “Mean Girls” bears a striking resemblance to the actual sex education courses taught in schools across the United States today. In fact, things may have gotten measurably worse.

National data recently published by the Guttmacher Institute showed that adolescents were less likely to receive adequate sex education from 2015 to 2019 than they were in 1995. Only half of kids aged 15-19 received sex education that met minimum standards recommended by the Department of Health & Human Services, and fewer than half were given this information before having sex for the first time. With such a vast learning gap, it is no surprise that the United States has some of the highest rates of teenage pregnancy and sexually transmitted infections in the developed world.

Concerned and motivated by this need for sex education, physicians and other medical professionals are stepping in to fill the void, offering sexual health information through a range of methods to students of all ages (some a lot older than one may think). It is a calling that takes them outside their hospitals and exam rooms into workshops and through educational materials, video, and social media content created from scratch.

“The fact that we’re able to go in and provide factual, scientific, important information that can affect the trajectory of someone’s life is powerful,” said Julia Rossen, part of a contingent of med students at Brown University, Providence, R.I., who now teach sex ed as an elective.

Their goals are not just about protecting health. Many are also teaching about other topics commonly ignored in sex education classes, such as consent, pleasure, LGBTQ+ identities, and cultural competence. There is a mutually beneficial relationship, they say, between their sex education work and their medical practice.
 

Changing the status quo

A jumble of state laws govern how and when schools should offer sex education courses. Individual school districts often make the final decisions about their content, creating even more inconsistent standards. Only 29 states and the District of Columbia mandate sex education, and 13 of those do not require that it be medically accurate. Abstinence-only education, which has been shown to be ineffective, is exclusively taught in 16 states.

Without formal instruction, many young people must learn about sex from family members, who may be unwilling, or they may share knowledge between themselves, which is often incorrect, or navigate the limitless information and misinformation available on the internet.

The consequences of this were apparent to several medical students at Brown University in 2013. At the time, the rate of teenage pregnancy across Rhode Island was 1 in 100, but in the small city of Central Falls, it was 1 in 25. Aiming to improve this, the group created a comprehensive sex education program for a Central Falls middle school that was taught by medical student volunteers.

The Sex Ed by Brown Med program continues today. It consists of eight in-person sessions. Topics include anatomy, contraception, STIs, sexual decision-making, consent, sexual violence, and sexual and gender identity. Through this program, as well as other factors, the Central Falls teenage pregnancy rate declined to 1.6 in 100 from 2016 to 2020, according to the Rhode Island Department of Health.

“Historically, sexual education has been politicized,” said Ms. Rossen, one of the current program leaders. “It’s been at the discretion of a lot of different factors that aren’t under the control of the communities that are actually receiving the education.”

Among seventh graders, the teachers say they encounter different levels of maturity. But they feel that the kids are more receptive and open with younger adults who, like them, are still students. Some volunteers recall the flaws in their own sex education, particularly regarding topics such as consent and gender and sexual identity, and they believe middle school is the time to begin the sexual health conversation. “By the time you’re talking to college-age students, it’s pretty much too late,” said another group leader, Benjamin Stone.

Mr. Stone feels that practicing having these often-awkward discussions enhances their clinical skills as physicians. “Sex and sexual history are part of the comprehensive medical interview. People want to have these conversations, and they’re looking for someone to open the door. The kids are excited that we’re opening that door for them. And I think patients feel the same way.”
 

Conquering social media

Opening the door has been more like releasing a floodgate for Danielle Jones, MD, an ob.gyn. physician who is originally from Texas but who moved to New Zealand in 2021. Known on social media as “Mama Doctor Jones,” she has garnered more than 3 million followers across YouTube, TikTok, Twitter, Instagram, and Facebook. Dr. Jones produces short, friendly, entertaining videos on a range of reproductive health and sex education topics. They appeal to an adolescent audience hungry for a trustworthy voice on issues such as,: “5 ‘Strange’ Things Your Vagina Does That Are NORMAL” and “Condom Broke ... Now What?”

Dr. Jones uses her platform to debunk some of the misleading and inaccurate sexual health information being taught in classrooms, by other social media influencers, and that is found on the internet in general. Her no-nonsense-style videos call out such myths as being unable to pee with a tampon in, Plan B emergency contraception causing abortions, and COVID-19 vaccines damaging fertility.

“The way sex ed is done in the U.S. in most places is continuing the taboo by making it a one-time discussion or health class,” said Dr. Jones, “particularly if boys and girls are separated. That doesn’t further communication between people or foster an environment where it’s okay to discuss your body and puberty and changes in sexual health in general. And if you can’t talk about it in educational spaces, you’re certainly not going to be comfortable talking about that in a one-on-one situation with another 16-year-old.”

Taking on other taboos, Dr. Jones has been outspoken about abortion and the consequences of the recent Supreme Court decision, both as an ethical issue and a medical one that endangers lives. Raised in a deeply religious family, Dr. Jones said she was indoctrinated with antiabortion views, and it took time for her thinking to evolve “from a scientific and humanistic standpoint.” While working in a Texas private practice, Dr. Jones described being unable to mention abortion online because of fear of losing her patients and for her own safety.

Now free of those constraints, Dr. Jones feels that her videos can be important resources for teachers who may have little health training. And she is enthusiastic about the complementary relationship between her social media work and her clinical practice. “There are conversations I have all the time in the clinic where patients tell me: ‘Nobody’s ever really had this conversation in this way with me. Thank you for explaining that,’ ” said Dr. Jones. “And then I think: ‘Well, now I’ll have it with a hundred thousand other people too.’ ”
 

Promoting pleasure

While not an ob.gyn., discussing sexuality with patients has become a focus for Evelin Dacker, MD, a family physician in Salem, Ore. Dr. Dacker is certified in functional medicine, which takes a holistic and integrative approach. During her training she had a sudden realization: Sexuality had not been discussed at any point during her medical education.

“I recognized that this was a huge gap in how we deal with a person as a human,” Dr. Dacker explained. “Since sexuality plays a role in so many aspects of our humanness, not just having sex.”

Dr. Dacker believes in rethinking sexuality as a fundamental part of overall health, as vital as nutrition or blood pressure. Outside her medical practice, she teaches classes and workshops on sexual health and sex positivity for young adults and other physicians. She has also developed an educational framework for sexual health topics. Dr. Dacker said she frequently confronts the idea that sexuality is only about engaging with another person. She disagrees. Using food as a metaphor, she argues that just as the pleasure of eating something is purely for oneself, sexuality belongs to the individual.

Sexuality can also be a tool for pleasure, which Dr. Dacker believes plays an essential role in physical health. “Pleasure is a medicine,” Dr. Dacker said. “I actually prescribe self-pleasure practices to my patients, so they can start owning it within themselves. Make sure you get 7-8 hours of sleep, do some breathing exercises to help bring down your stress, and do self-pleasure so that you can integrate into your body better.”

She added that the impact of prioritizing one’s own desires, needs, and boundaries can transform how people view their sexuality. Her adult students frequently ask: “Why wasn’t I taught this as a teenager?”
 

Speaking of adult students – An older generation learns new tricks

While the teen cohort is usually the focus, the lack of sex education in previous decades – and the way sexual culture has evolved in that time – have an impact on older groups. Among U.S. adults aged 55 and older, the rate of STIs has more than doubled in the past 10 years, according to the Centers for Disease Control and Prevention. While the majority of STI cases still occur among teenagers and young adults, the consistent increase in STIs among older persons is cause for concern among physicians and researchers.

The issue worries Shannon Dowler, MD, a family physician in western North Carolina and chief medical officer for North Carolina Medicaid. Dr. Dowler, who has practiced in an STI clinic throughout her career, began seeing more and more older adults with chlamydia, herpes, and other STIs. Dowler cites several factors behind the rise, including the growing retirement community population, the availability of pharmaceuticals for sexual dysfunction, and the “hook-up culture” that is active on dating apps, which research shows are regularly used by more than a third of adults older than 55.

Dr. Dowler also sees a lack of communication about sexual health between physicians and their older patients. “Older adults are more likely to be in relationship with their physician outside the exam room, especially if they’re in a small community,” Dr. Dowler said. “Sometimes they aren’t as comfortable sharing what their risks are. But we are guilty in medicine all the time of not asking. We assume someone’s older so they’re not having sex anymore. But, in fact, they are, and we’re not taking the time to say: ‘Let’s talk about your sex life. Are you at risk for anything? Are you having any difficulties with sex?’ We tend to avoid it as a health care culture.”

In contrast, Dr. Dowler said she talks about sexual health with anyone who will listen. She teaches classes in private schools and universities and for church youth groups and other physicians. She often finds that public schools are not interested, which she attributes to fear of her discussing things “outside the rule book.”

Dr. Dowler takes creative approaches. In 2017, she released a hip-hop video, “STD’s Never Get Old,” in which she raps about safe sex for older adults. Her video went viral, was mentioned by several news outlets, and received over 50,000 views on YouTube. Dr. Dowler’s latest project is a book, “Never Too Late: Your Guide to Safer Sex after 60,” which is scheduled for publication on Valentine’s Day, 2023.

“It’s sex ed for seniors,” she explained. “It’s that gym class that some people got – I won’t say everyone got – in high school. This is the version for older adults who didn’t get that. There are new infections now that didn’t exist when they had sex education, if they had sex education.”
 

A big subject requires a big mission

For others in the sex education field, physicians are allies in their fight against agendas designed to obstruct or erode sex education. Alison Macklin, director of policy and advocacy at SIECUS: Sex Ed for Social Change, formerly the Sexuality Information and Education Council of the United States, sees this struggle playing out in school boards and state legislatures across the country. For every comprehensive sex education bill passed or school district victory, there is yet another blocked proposal or restrictive law somewhere else.

Ms. Macklin urged doctors to get more involved locally and to expand their knowledge of sexual health issues by reaching out to organizations such as Planned Parenthood and to be “hyper vigilant” in their own communities.

“Doctors are trusted. People really respect what they have to say,” Ms. Macklin said. “And this is an important time for them to speak up.”

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

An athletic coach stands in front of a packed gym full of high school students.
 

“Don’t have sex,” he instructs, “because you will get pregnant and die. Don’t have sex in the missionary position. Don’t have sex standing up. Just don’t do it, promise? Okay, everybody take some rubbers.”

Sad to say, this scene from the 2004 movie “Mean Girls” bears a striking resemblance to the actual sex education courses taught in schools across the United States today. In fact, things may have gotten measurably worse.

National data recently published by the Guttmacher Institute showed that adolescents were less likely to receive adequate sex education from 2015 to 2019 than they were in 1995. Only half of kids aged 15-19 received sex education that met minimum standards recommended by the Department of Health & Human Services, and fewer than half were given this information before having sex for the first time. With such a vast learning gap, it is no surprise that the United States has some of the highest rates of teenage pregnancy and sexually transmitted infections in the developed world.

Concerned and motivated by this need for sex education, physicians and other medical professionals are stepping in to fill the void, offering sexual health information through a range of methods to students of all ages (some a lot older than one may think). It is a calling that takes them outside their hospitals and exam rooms into workshops and through educational materials, video, and social media content created from scratch.

“The fact that we’re able to go in and provide factual, scientific, important information that can affect the trajectory of someone’s life is powerful,” said Julia Rossen, part of a contingent of med students at Brown University, Providence, R.I., who now teach sex ed as an elective.

Their goals are not just about protecting health. Many are also teaching about other topics commonly ignored in sex education classes, such as consent, pleasure, LGBTQ+ identities, and cultural competence. There is a mutually beneficial relationship, they say, between their sex education work and their medical practice.
 

Changing the status quo

A jumble of state laws govern how and when schools should offer sex education courses. Individual school districts often make the final decisions about their content, creating even more inconsistent standards. Only 29 states and the District of Columbia mandate sex education, and 13 of those do not require that it be medically accurate. Abstinence-only education, which has been shown to be ineffective, is exclusively taught in 16 states.

Without formal instruction, many young people must learn about sex from family members, who may be unwilling, or they may share knowledge between themselves, which is often incorrect, or navigate the limitless information and misinformation available on the internet.

The consequences of this were apparent to several medical students at Brown University in 2013. At the time, the rate of teenage pregnancy across Rhode Island was 1 in 100, but in the small city of Central Falls, it was 1 in 25. Aiming to improve this, the group created a comprehensive sex education program for a Central Falls middle school that was taught by medical student volunteers.

The Sex Ed by Brown Med program continues today. It consists of eight in-person sessions. Topics include anatomy, contraception, STIs, sexual decision-making, consent, sexual violence, and sexual and gender identity. Through this program, as well as other factors, the Central Falls teenage pregnancy rate declined to 1.6 in 100 from 2016 to 2020, according to the Rhode Island Department of Health.

“Historically, sexual education has been politicized,” said Ms. Rossen, one of the current program leaders. “It’s been at the discretion of a lot of different factors that aren’t under the control of the communities that are actually receiving the education.”

Among seventh graders, the teachers say they encounter different levels of maturity. But they feel that the kids are more receptive and open with younger adults who, like them, are still students. Some volunteers recall the flaws in their own sex education, particularly regarding topics such as consent and gender and sexual identity, and they believe middle school is the time to begin the sexual health conversation. “By the time you’re talking to college-age students, it’s pretty much too late,” said another group leader, Benjamin Stone.

Mr. Stone feels that practicing having these often-awkward discussions enhances their clinical skills as physicians. “Sex and sexual history are part of the comprehensive medical interview. People want to have these conversations, and they’re looking for someone to open the door. The kids are excited that we’re opening that door for them. And I think patients feel the same way.”
 

Conquering social media

Opening the door has been more like releasing a floodgate for Danielle Jones, MD, an ob.gyn. physician who is originally from Texas but who moved to New Zealand in 2021. Known on social media as “Mama Doctor Jones,” she has garnered more than 3 million followers across YouTube, TikTok, Twitter, Instagram, and Facebook. Dr. Jones produces short, friendly, entertaining videos on a range of reproductive health and sex education topics. They appeal to an adolescent audience hungry for a trustworthy voice on issues such as,: “5 ‘Strange’ Things Your Vagina Does That Are NORMAL” and “Condom Broke ... Now What?”

Dr. Jones uses her platform to debunk some of the misleading and inaccurate sexual health information being taught in classrooms, by other social media influencers, and that is found on the internet in general. Her no-nonsense-style videos call out such myths as being unable to pee with a tampon in, Plan B emergency contraception causing abortions, and COVID-19 vaccines damaging fertility.

“The way sex ed is done in the U.S. in most places is continuing the taboo by making it a one-time discussion or health class,” said Dr. Jones, “particularly if boys and girls are separated. That doesn’t further communication between people or foster an environment where it’s okay to discuss your body and puberty and changes in sexual health in general. And if you can’t talk about it in educational spaces, you’re certainly not going to be comfortable talking about that in a one-on-one situation with another 16-year-old.”

Taking on other taboos, Dr. Jones has been outspoken about abortion and the consequences of the recent Supreme Court decision, both as an ethical issue and a medical one that endangers lives. Raised in a deeply religious family, Dr. Jones said she was indoctrinated with antiabortion views, and it took time for her thinking to evolve “from a scientific and humanistic standpoint.” While working in a Texas private practice, Dr. Jones described being unable to mention abortion online because of fear of losing her patients and for her own safety.

Now free of those constraints, Dr. Jones feels that her videos can be important resources for teachers who may have little health training. And she is enthusiastic about the complementary relationship between her social media work and her clinical practice. “There are conversations I have all the time in the clinic where patients tell me: ‘Nobody’s ever really had this conversation in this way with me. Thank you for explaining that,’ ” said Dr. Jones. “And then I think: ‘Well, now I’ll have it with a hundred thousand other people too.’ ”
 

Promoting pleasure

While not an ob.gyn., discussing sexuality with patients has become a focus for Evelin Dacker, MD, a family physician in Salem, Ore. Dr. Dacker is certified in functional medicine, which takes a holistic and integrative approach. During her training she had a sudden realization: Sexuality had not been discussed at any point during her medical education.

“I recognized that this was a huge gap in how we deal with a person as a human,” Dr. Dacker explained. “Since sexuality plays a role in so many aspects of our humanness, not just having sex.”

Dr. Dacker believes in rethinking sexuality as a fundamental part of overall health, as vital as nutrition or blood pressure. Outside her medical practice, she teaches classes and workshops on sexual health and sex positivity for young adults and other physicians. She has also developed an educational framework for sexual health topics. Dr. Dacker said she frequently confronts the idea that sexuality is only about engaging with another person. She disagrees. Using food as a metaphor, she argues that just as the pleasure of eating something is purely for oneself, sexuality belongs to the individual.

Sexuality can also be a tool for pleasure, which Dr. Dacker believes plays an essential role in physical health. “Pleasure is a medicine,” Dr. Dacker said. “I actually prescribe self-pleasure practices to my patients, so they can start owning it within themselves. Make sure you get 7-8 hours of sleep, do some breathing exercises to help bring down your stress, and do self-pleasure so that you can integrate into your body better.”

She added that the impact of prioritizing one’s own desires, needs, and boundaries can transform how people view their sexuality. Her adult students frequently ask: “Why wasn’t I taught this as a teenager?”
 

Speaking of adult students – An older generation learns new tricks

While the teen cohort is usually the focus, the lack of sex education in previous decades – and the way sexual culture has evolved in that time – have an impact on older groups. Among U.S. adults aged 55 and older, the rate of STIs has more than doubled in the past 10 years, according to the Centers for Disease Control and Prevention. While the majority of STI cases still occur among teenagers and young adults, the consistent increase in STIs among older persons is cause for concern among physicians and researchers.

The issue worries Shannon Dowler, MD, a family physician in western North Carolina and chief medical officer for North Carolina Medicaid. Dr. Dowler, who has practiced in an STI clinic throughout her career, began seeing more and more older adults with chlamydia, herpes, and other STIs. Dowler cites several factors behind the rise, including the growing retirement community population, the availability of pharmaceuticals for sexual dysfunction, and the “hook-up culture” that is active on dating apps, which research shows are regularly used by more than a third of adults older than 55.

Dr. Dowler also sees a lack of communication about sexual health between physicians and their older patients. “Older adults are more likely to be in relationship with their physician outside the exam room, especially if they’re in a small community,” Dr. Dowler said. “Sometimes they aren’t as comfortable sharing what their risks are. But we are guilty in medicine all the time of not asking. We assume someone’s older so they’re not having sex anymore. But, in fact, they are, and we’re not taking the time to say: ‘Let’s talk about your sex life. Are you at risk for anything? Are you having any difficulties with sex?’ We tend to avoid it as a health care culture.”

In contrast, Dr. Dowler said she talks about sexual health with anyone who will listen. She teaches classes in private schools and universities and for church youth groups and other physicians. She often finds that public schools are not interested, which she attributes to fear of her discussing things “outside the rule book.”

Dr. Dowler takes creative approaches. In 2017, she released a hip-hop video, “STD’s Never Get Old,” in which she raps about safe sex for older adults. Her video went viral, was mentioned by several news outlets, and received over 50,000 views on YouTube. Dr. Dowler’s latest project is a book, “Never Too Late: Your Guide to Safer Sex after 60,” which is scheduled for publication on Valentine’s Day, 2023.

“It’s sex ed for seniors,” she explained. “It’s that gym class that some people got – I won’t say everyone got – in high school. This is the version for older adults who didn’t get that. There are new infections now that didn’t exist when they had sex education, if they had sex education.”
 

A big subject requires a big mission

For others in the sex education field, physicians are allies in their fight against agendas designed to obstruct or erode sex education. Alison Macklin, director of policy and advocacy at SIECUS: Sex Ed for Social Change, formerly the Sexuality Information and Education Council of the United States, sees this struggle playing out in school boards and state legislatures across the country. For every comprehensive sex education bill passed or school district victory, there is yet another blocked proposal or restrictive law somewhere else.

Ms. Macklin urged doctors to get more involved locally and to expand their knowledge of sexual health issues by reaching out to organizations such as Planned Parenthood and to be “hyper vigilant” in their own communities.

“Doctors are trusted. People really respect what they have to say,” Ms. Macklin said. “And this is an important time for them to speak up.”

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

An athletic coach stands in front of a packed gym full of high school students.
 

“Don’t have sex,” he instructs, “because you will get pregnant and die. Don’t have sex in the missionary position. Don’t have sex standing up. Just don’t do it, promise? Okay, everybody take some rubbers.”

Sad to say, this scene from the 2004 movie “Mean Girls” bears a striking resemblance to the actual sex education courses taught in schools across the United States today. In fact, things may have gotten measurably worse.

National data recently published by the Guttmacher Institute showed that adolescents were less likely to receive adequate sex education from 2015 to 2019 than they were in 1995. Only half of kids aged 15-19 received sex education that met minimum standards recommended by the Department of Health & Human Services, and fewer than half were given this information before having sex for the first time. With such a vast learning gap, it is no surprise that the United States has some of the highest rates of teenage pregnancy and sexually transmitted infections in the developed world.

Concerned and motivated by this need for sex education, physicians and other medical professionals are stepping in to fill the void, offering sexual health information through a range of methods to students of all ages (some a lot older than one may think). It is a calling that takes them outside their hospitals and exam rooms into workshops and through educational materials, video, and social media content created from scratch.

“The fact that we’re able to go in and provide factual, scientific, important information that can affect the trajectory of someone’s life is powerful,” said Julia Rossen, part of a contingent of med students at Brown University, Providence, R.I., who now teach sex ed as an elective.

Their goals are not just about protecting health. Many are also teaching about other topics commonly ignored in sex education classes, such as consent, pleasure, LGBTQ+ identities, and cultural competence. There is a mutually beneficial relationship, they say, between their sex education work and their medical practice.
 

Changing the status quo

A jumble of state laws govern how and when schools should offer sex education courses. Individual school districts often make the final decisions about their content, creating even more inconsistent standards. Only 29 states and the District of Columbia mandate sex education, and 13 of those do not require that it be medically accurate. Abstinence-only education, which has been shown to be ineffective, is exclusively taught in 16 states.

Without formal instruction, many young people must learn about sex from family members, who may be unwilling, or they may share knowledge between themselves, which is often incorrect, or navigate the limitless information and misinformation available on the internet.

The consequences of this were apparent to several medical students at Brown University in 2013. At the time, the rate of teenage pregnancy across Rhode Island was 1 in 100, but in the small city of Central Falls, it was 1 in 25. Aiming to improve this, the group created a comprehensive sex education program for a Central Falls middle school that was taught by medical student volunteers.

The Sex Ed by Brown Med program continues today. It consists of eight in-person sessions. Topics include anatomy, contraception, STIs, sexual decision-making, consent, sexual violence, and sexual and gender identity. Through this program, as well as other factors, the Central Falls teenage pregnancy rate declined to 1.6 in 100 from 2016 to 2020, according to the Rhode Island Department of Health.

“Historically, sexual education has been politicized,” said Ms. Rossen, one of the current program leaders. “It’s been at the discretion of a lot of different factors that aren’t under the control of the communities that are actually receiving the education.”

Among seventh graders, the teachers say they encounter different levels of maturity. But they feel that the kids are more receptive and open with younger adults who, like them, are still students. Some volunteers recall the flaws in their own sex education, particularly regarding topics such as consent and gender and sexual identity, and they believe middle school is the time to begin the sexual health conversation. “By the time you’re talking to college-age students, it’s pretty much too late,” said another group leader, Benjamin Stone.

Mr. Stone feels that practicing having these often-awkward discussions enhances their clinical skills as physicians. “Sex and sexual history are part of the comprehensive medical interview. People want to have these conversations, and they’re looking for someone to open the door. The kids are excited that we’re opening that door for them. And I think patients feel the same way.”
 

Conquering social media

Opening the door has been more like releasing a floodgate for Danielle Jones, MD, an ob.gyn. physician who is originally from Texas but who moved to New Zealand in 2021. Known on social media as “Mama Doctor Jones,” she has garnered more than 3 million followers across YouTube, TikTok, Twitter, Instagram, and Facebook. Dr. Jones produces short, friendly, entertaining videos on a range of reproductive health and sex education topics. They appeal to an adolescent audience hungry for a trustworthy voice on issues such as,: “5 ‘Strange’ Things Your Vagina Does That Are NORMAL” and “Condom Broke ... Now What?”

Dr. Jones uses her platform to debunk some of the misleading and inaccurate sexual health information being taught in classrooms, by other social media influencers, and that is found on the internet in general. Her no-nonsense-style videos call out such myths as being unable to pee with a tampon in, Plan B emergency contraception causing abortions, and COVID-19 vaccines damaging fertility.

“The way sex ed is done in the U.S. in most places is continuing the taboo by making it a one-time discussion or health class,” said Dr. Jones, “particularly if boys and girls are separated. That doesn’t further communication between people or foster an environment where it’s okay to discuss your body and puberty and changes in sexual health in general. And if you can’t talk about it in educational spaces, you’re certainly not going to be comfortable talking about that in a one-on-one situation with another 16-year-old.”

Taking on other taboos, Dr. Jones has been outspoken about abortion and the consequences of the recent Supreme Court decision, both as an ethical issue and a medical one that endangers lives. Raised in a deeply religious family, Dr. Jones said she was indoctrinated with antiabortion views, and it took time for her thinking to evolve “from a scientific and humanistic standpoint.” While working in a Texas private practice, Dr. Jones described being unable to mention abortion online because of fear of losing her patients and for her own safety.

Now free of those constraints, Dr. Jones feels that her videos can be important resources for teachers who may have little health training. And she is enthusiastic about the complementary relationship between her social media work and her clinical practice. “There are conversations I have all the time in the clinic where patients tell me: ‘Nobody’s ever really had this conversation in this way with me. Thank you for explaining that,’ ” said Dr. Jones. “And then I think: ‘Well, now I’ll have it with a hundred thousand other people too.’ ”
 

Promoting pleasure

While not an ob.gyn., discussing sexuality with patients has become a focus for Evelin Dacker, MD, a family physician in Salem, Ore. Dr. Dacker is certified in functional medicine, which takes a holistic and integrative approach. During her training she had a sudden realization: Sexuality had not been discussed at any point during her medical education.

“I recognized that this was a huge gap in how we deal with a person as a human,” Dr. Dacker explained. “Since sexuality plays a role in so many aspects of our humanness, not just having sex.”

Dr. Dacker believes in rethinking sexuality as a fundamental part of overall health, as vital as nutrition or blood pressure. Outside her medical practice, she teaches classes and workshops on sexual health and sex positivity for young adults and other physicians. She has also developed an educational framework for sexual health topics. Dr. Dacker said she frequently confronts the idea that sexuality is only about engaging with another person. She disagrees. Using food as a metaphor, she argues that just as the pleasure of eating something is purely for oneself, sexuality belongs to the individual.

Sexuality can also be a tool for pleasure, which Dr. Dacker believes plays an essential role in physical health. “Pleasure is a medicine,” Dr. Dacker said. “I actually prescribe self-pleasure practices to my patients, so they can start owning it within themselves. Make sure you get 7-8 hours of sleep, do some breathing exercises to help bring down your stress, and do self-pleasure so that you can integrate into your body better.”

She added that the impact of prioritizing one’s own desires, needs, and boundaries can transform how people view their sexuality. Her adult students frequently ask: “Why wasn’t I taught this as a teenager?”
 

Speaking of adult students – An older generation learns new tricks

While the teen cohort is usually the focus, the lack of sex education in previous decades – and the way sexual culture has evolved in that time – have an impact on older groups. Among U.S. adults aged 55 and older, the rate of STIs has more than doubled in the past 10 years, according to the Centers for Disease Control and Prevention. While the majority of STI cases still occur among teenagers and young adults, the consistent increase in STIs among older persons is cause for concern among physicians and researchers.

The issue worries Shannon Dowler, MD, a family physician in western North Carolina and chief medical officer for North Carolina Medicaid. Dr. Dowler, who has practiced in an STI clinic throughout her career, began seeing more and more older adults with chlamydia, herpes, and other STIs. Dowler cites several factors behind the rise, including the growing retirement community population, the availability of pharmaceuticals for sexual dysfunction, and the “hook-up culture” that is active on dating apps, which research shows are regularly used by more than a third of adults older than 55.

Dr. Dowler also sees a lack of communication about sexual health between physicians and their older patients. “Older adults are more likely to be in relationship with their physician outside the exam room, especially if they’re in a small community,” Dr. Dowler said. “Sometimes they aren’t as comfortable sharing what their risks are. But we are guilty in medicine all the time of not asking. We assume someone’s older so they’re not having sex anymore. But, in fact, they are, and we’re not taking the time to say: ‘Let’s talk about your sex life. Are you at risk for anything? Are you having any difficulties with sex?’ We tend to avoid it as a health care culture.”

In contrast, Dr. Dowler said she talks about sexual health with anyone who will listen. She teaches classes in private schools and universities and for church youth groups and other physicians. She often finds that public schools are not interested, which she attributes to fear of her discussing things “outside the rule book.”

Dr. Dowler takes creative approaches. In 2017, she released a hip-hop video, “STD’s Never Get Old,” in which she raps about safe sex for older adults. Her video went viral, was mentioned by several news outlets, and received over 50,000 views on YouTube. Dr. Dowler’s latest project is a book, “Never Too Late: Your Guide to Safer Sex after 60,” which is scheduled for publication on Valentine’s Day, 2023.

“It’s sex ed for seniors,” she explained. “It’s that gym class that some people got – I won’t say everyone got – in high school. This is the version for older adults who didn’t get that. There are new infections now that didn’t exist when they had sex education, if they had sex education.”
 

A big subject requires a big mission

For others in the sex education field, physicians are allies in their fight against agendas designed to obstruct or erode sex education. Alison Macklin, director of policy and advocacy at SIECUS: Sex Ed for Social Change, formerly the Sexuality Information and Education Council of the United States, sees this struggle playing out in school boards and state legislatures across the country. For every comprehensive sex education bill passed or school district victory, there is yet another blocked proposal or restrictive law somewhere else.

Ms. Macklin urged doctors to get more involved locally and to expand their knowledge of sexual health issues by reaching out to organizations such as Planned Parenthood and to be “hyper vigilant” in their own communities.

“Doctors are trusted. People really respect what they have to say,” Ms. Macklin said. “And this is an important time for them to speak up.”

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

Race, ethnicity, and socioeconomic status are closely associated with visual impairment in adolescents in the United States, researchers have found.

The study showed that adolescents who identified as Black, Mexican-American, of low income, or as non–U.S. citizens were two to three times more likely than White adolescents to report vision problems and to perform worse on objective tests of visual acuity.

Although disparities in visual impairment with respect to ethnic, racial, and socioeconomic status have been described among adults, little research has explored the adolescent population, according to the researchers, whose findings appear in JAMA Ophthalmology.

“The primary motivation behind trying to figure out exactly when these disparities emerge is that it gives us an opportunity to come up with ideas for interventions that can potentially address them before they manifest in a way that they are no longer treatable,” said Isdin Oke, MD, an instructor in ophthalmology at Harvard Medical School, Boston, who led the latest study.

Dr. Oke and his colleagues analyzed the records of 2,833 children and adolescents aged 12 through 18 years (mean, 15.5 years; 49% female) in the National Health and Nutrition Examination Survey. All the participants had completed a visual function questionnaire and had undergone an eye examination. The primary outcomes of the study were subjective (self-reported) poor vision and objective measures of visual function (visual acuity worse than 20/40 in the better-seeing eye).

Of the study participants, 14% were non-Hispanic Black, 11% were Mexican-American, 63% were non-Hispanic White, and 11% were of other race and ethnicity. Five percent of participants were not U.S. citizens, and 19% had a family income below the poverty threshold.

After accounting for potential confounders, self-reported poor vision was more common among Black (odds ratio, 2.85; 95% CI, 2.00-4.05; P < .001), Mexican-American (OR, 2.83; 95% CI, 1.70-4.73; P < .001), and low-income youth (OR, 2.44; 95% CI, 1.63-3.65; P < .001), the researchers report.

The study also found increased odds of visual acuity below 20/40 in the better-seeing eye among Black (OR, 2.13; 95% CI, 1.41-3.24; P = .001) and Mexican-American adolescents (OR, 2.13; 95% CI, 1.39-3.26; P = .001) and non–U.S. citizens (OR, 1.96; 95% CI, 1.10-3.49; P = .02).

Black and Mexican-American adolescents were almost three times more likely to suffer poor subjective visual function and twice as likely to have low objective visual acuity than non-Hispanic White youth, according to the researchers.

“I think it’s something that health care providers, and even the population as a whole, should be more aware of,” Dr. Oke said.
 

Opportunities for intervention

Dr. Oke said the findings likely reflect the underlying inequities in access to vision care experienced by these persons.

“There are a lot of opportunities for early intervention, whether it’s through vision screening or improving access to vision services for children and adolescents that can really make a big difference over the long term,” he told this news organization.

Michael F. Chiang, MD, director of the National Eye Institute at the National Institutes of Health, Bethesda, Md., agreed that more steps need to be taken to improve access to vision care for all Americans.

“There are good data showing that we don’t have a sufficient number of eye care providers and health-services clinical researchers who come from backgrounds that are currently underrepresented in medicine and science,” Dr. Chiang said. “Therefore, we need to find ways to inspire, recruit, and train a larger number of people to strengthen our vision workforce.”

Other ways to address these gaps in care, he added, include improving understanding of the social determinants of vision health as well as developing ways to improve access to eye care.

“That may include new models of eye care, like telehealth to improve outreach, and will likely need to include what we call implementation science, so clinicians can better adopt these measures,” he said.

Dr. Oke and Dr. Chiang reported no relevant financial relationships.

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

Race, ethnicity, and socioeconomic status are closely associated with visual impairment in adolescents in the United States, researchers have found.

The study showed that adolescents who identified as Black, Mexican-American, of low income, or as non–U.S. citizens were two to three times more likely than White adolescents to report vision problems and to perform worse on objective tests of visual acuity.

Although disparities in visual impairment with respect to ethnic, racial, and socioeconomic status have been described among adults, little research has explored the adolescent population, according to the researchers, whose findings appear in JAMA Ophthalmology.

“The primary motivation behind trying to figure out exactly when these disparities emerge is that it gives us an opportunity to come up with ideas for interventions that can potentially address them before they manifest in a way that they are no longer treatable,” said Isdin Oke, MD, an instructor in ophthalmology at Harvard Medical School, Boston, who led the latest study.

Dr. Oke and his colleagues analyzed the records of 2,833 children and adolescents aged 12 through 18 years (mean, 15.5 years; 49% female) in the National Health and Nutrition Examination Survey. All the participants had completed a visual function questionnaire and had undergone an eye examination. The primary outcomes of the study were subjective (self-reported) poor vision and objective measures of visual function (visual acuity worse than 20/40 in the better-seeing eye).

Of the study participants, 14% were non-Hispanic Black, 11% were Mexican-American, 63% were non-Hispanic White, and 11% were of other race and ethnicity. Five percent of participants were not U.S. citizens, and 19% had a family income below the poverty threshold.

After accounting for potential confounders, self-reported poor vision was more common among Black (odds ratio, 2.85; 95% CI, 2.00-4.05; P < .001), Mexican-American (OR, 2.83; 95% CI, 1.70-4.73; P < .001), and low-income youth (OR, 2.44; 95% CI, 1.63-3.65; P < .001), the researchers report.

The study also found increased odds of visual acuity below 20/40 in the better-seeing eye among Black (OR, 2.13; 95% CI, 1.41-3.24; P = .001) and Mexican-American adolescents (OR, 2.13; 95% CI, 1.39-3.26; P = .001) and non–U.S. citizens (OR, 1.96; 95% CI, 1.10-3.49; P = .02).

Black and Mexican-American adolescents were almost three times more likely to suffer poor subjective visual function and twice as likely to have low objective visual acuity than non-Hispanic White youth, according to the researchers.

“I think it’s something that health care providers, and even the population as a whole, should be more aware of,” Dr. Oke said.
 

Opportunities for intervention

Dr. Oke said the findings likely reflect the underlying inequities in access to vision care experienced by these persons.

“There are a lot of opportunities for early intervention, whether it’s through vision screening or improving access to vision services for children and adolescents that can really make a big difference over the long term,” he told this news organization.

Michael F. Chiang, MD, director of the National Eye Institute at the National Institutes of Health, Bethesda, Md., agreed that more steps need to be taken to improve access to vision care for all Americans.

“There are good data showing that we don’t have a sufficient number of eye care providers and health-services clinical researchers who come from backgrounds that are currently underrepresented in medicine and science,” Dr. Chiang said. “Therefore, we need to find ways to inspire, recruit, and train a larger number of people to strengthen our vision workforce.”

Other ways to address these gaps in care, he added, include improving understanding of the social determinants of vision health as well as developing ways to improve access to eye care.

“That may include new models of eye care, like telehealth to improve outreach, and will likely need to include what we call implementation science, so clinicians can better adopt these measures,” he said.

Dr. Oke and Dr. Chiang reported no relevant financial relationships.

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

Race, ethnicity, and socioeconomic status are closely associated with visual impairment in adolescents in the United States, researchers have found.

The study showed that adolescents who identified as Black, Mexican-American, of low income, or as non–U.S. citizens were two to three times more likely than White adolescents to report vision problems and to perform worse on objective tests of visual acuity.

Although disparities in visual impairment with respect to ethnic, racial, and socioeconomic status have been described among adults, little research has explored the adolescent population, according to the researchers, whose findings appear in JAMA Ophthalmology.

“The primary motivation behind trying to figure out exactly when these disparities emerge is that it gives us an opportunity to come up with ideas for interventions that can potentially address them before they manifest in a way that they are no longer treatable,” said Isdin Oke, MD, an instructor in ophthalmology at Harvard Medical School, Boston, who led the latest study.

Dr. Oke and his colleagues analyzed the records of 2,833 children and adolescents aged 12 through 18 years (mean, 15.5 years; 49% female) in the National Health and Nutrition Examination Survey. All the participants had completed a visual function questionnaire and had undergone an eye examination. The primary outcomes of the study were subjective (self-reported) poor vision and objective measures of visual function (visual acuity worse than 20/40 in the better-seeing eye).

Of the study participants, 14% were non-Hispanic Black, 11% were Mexican-American, 63% were non-Hispanic White, and 11% were of other race and ethnicity. Five percent of participants were not U.S. citizens, and 19% had a family income below the poverty threshold.

After accounting for potential confounders, self-reported poor vision was more common among Black (odds ratio, 2.85; 95% CI, 2.00-4.05; P < .001), Mexican-American (OR, 2.83; 95% CI, 1.70-4.73; P < .001), and low-income youth (OR, 2.44; 95% CI, 1.63-3.65; P < .001), the researchers report.

The study also found increased odds of visual acuity below 20/40 in the better-seeing eye among Black (OR, 2.13; 95% CI, 1.41-3.24; P = .001) and Mexican-American adolescents (OR, 2.13; 95% CI, 1.39-3.26; P = .001) and non–U.S. citizens (OR, 1.96; 95% CI, 1.10-3.49; P = .02).

Black and Mexican-American adolescents were almost three times more likely to suffer poor subjective visual function and twice as likely to have low objective visual acuity than non-Hispanic White youth, according to the researchers.

“I think it’s something that health care providers, and even the population as a whole, should be more aware of,” Dr. Oke said.
 

Opportunities for intervention

Dr. Oke said the findings likely reflect the underlying inequities in access to vision care experienced by these persons.

“There are a lot of opportunities for early intervention, whether it’s through vision screening or improving access to vision services for children and adolescents that can really make a big difference over the long term,” he told this news organization.

Michael F. Chiang, MD, director of the National Eye Institute at the National Institutes of Health, Bethesda, Md., agreed that more steps need to be taken to improve access to vision care for all Americans.

“There are good data showing that we don’t have a sufficient number of eye care providers and health-services clinical researchers who come from backgrounds that are currently underrepresented in medicine and science,” Dr. Chiang said. “Therefore, we need to find ways to inspire, recruit, and train a larger number of people to strengthen our vision workforce.”

Other ways to address these gaps in care, he added, include improving understanding of the social determinants of vision health as well as developing ways to improve access to eye care.

“That may include new models of eye care, like telehealth to improve outreach, and will likely need to include what we call implementation science, so clinicians can better adopt these measures,” he said.

Dr. Oke and Dr. Chiang reported no relevant financial relationships.

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

The Food and Drug Administration has issued a warning against cooking chicken in NyQuil after a social media challenge that encouraged people to try it went viral.

Called the “sleepy chicken challenge,” the trend tells people to cook chicken in NyQuil or similar over-the-counter cough and cold medications, which include ingredients such as acetaminophen, dextromethorphan, and doxylamine.

“The challenge sounds silly and unappetizing – and it is. But it could also be very unsafe,” the FDA said. “Boiling a medication can make it much more concentrated and change its properties in other ways.”

Even if someone doesn’t plan to eat the chicken, inhaling the vapors of the medication while it cooks could cause high levels of the drug to enter the body.

“It could also hurt your lungs,” the FDA said. “Put simply: Someone could take a dangerously high amount of the cough and cold medicine without even realizing it.”

This isn’t the first time that social media challenges involving medicine have gone viral. In a 2020 TikTok challenge, people were encouraged to take large doses of the allergy medicine diphenhydramine, called the “Benadryl challenge,” to cause hallucinations. The FDA received several reports of teens who were hospitalized or died, and it issued a warning about taking high doses of the drug.

“These video challenges, which often target youths, can harm people – and even cause death,” the FDA said. “Nonprescription (also called over-the-counter or OTC) drugs are readily available in many homes, making these challenges even more risky.”

In the latest warning, the FDA provided several ways for parents to make it less likely for children to do the social media challenges, such as locking up prescription and over-the-counter medications to prevent accidental overdoses. The FDA also encouraged parents and guardians to have open conversations with their children.

“Sit down with your children and discuss the dangers of misusing drugs and how social media trends can lead to real, sometimes irreversible, damage,” the FDA said. “Remind your children that overdoses can occur with OTC drugs as well as with prescription drugs.”

Following the FDA warning, the American Academy of Pediatrics also issued an advisory about social media trends. Some challenges, such as the ALS ice bucket challenge or the mannequin challenge, can be fun and positive activities. But medication-related challenges, such as the sleepy chicken and Benadryl challenges, can cause serious heart problems, seizures, coma, and even death.

“Teens’ brains are still developing. The part of the brain that handles rational thought, the prefrontal cortex, is not fully developed until the mid-20s,” the American Academy of Pediatrics said. “This means teens are naturally more impulsive and likely to act before thinking through all of the ramifications.”

Social media rewards outrageous behavior, it wrote, and the more outrageous the behavior, the more likely someone will get more engagement online.

“It’s a quick moving, impulsive environment, and the fear of losing out is real for teens,” the academy said. “What they will focus on is that a popular kid in class did this and got hundreds of likes and comments.”

The academy suggested that parents and guardians talk with teens about which challenges are trending on social media and at school.

“Sometimes kids are more willing to talk about their peers than themselves,” it said. “Asking questions about school trends, friends and fads may yield more answers than direct questions about their own activities.”

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

The Food and Drug Administration has issued a warning against cooking chicken in NyQuil after a social media challenge that encouraged people to try it went viral.

Called the “sleepy chicken challenge,” the trend tells people to cook chicken in NyQuil or similar over-the-counter cough and cold medications, which include ingredients such as acetaminophen, dextromethorphan, and doxylamine.

“The challenge sounds silly and unappetizing – and it is. But it could also be very unsafe,” the FDA said. “Boiling a medication can make it much more concentrated and change its properties in other ways.”

Even if someone doesn’t plan to eat the chicken, inhaling the vapors of the medication while it cooks could cause high levels of the drug to enter the body.

“It could also hurt your lungs,” the FDA said. “Put simply: Someone could take a dangerously high amount of the cough and cold medicine without even realizing it.”

This isn’t the first time that social media challenges involving medicine have gone viral. In a 2020 TikTok challenge, people were encouraged to take large doses of the allergy medicine diphenhydramine, called the “Benadryl challenge,” to cause hallucinations. The FDA received several reports of teens who were hospitalized or died, and it issued a warning about taking high doses of the drug.

“These video challenges, which often target youths, can harm people – and even cause death,” the FDA said. “Nonprescription (also called over-the-counter or OTC) drugs are readily available in many homes, making these challenges even more risky.”

In the latest warning, the FDA provided several ways for parents to make it less likely for children to do the social media challenges, such as locking up prescription and over-the-counter medications to prevent accidental overdoses. The FDA also encouraged parents and guardians to have open conversations with their children.

“Sit down with your children and discuss the dangers of misusing drugs and how social media trends can lead to real, sometimes irreversible, damage,” the FDA said. “Remind your children that overdoses can occur with OTC drugs as well as with prescription drugs.”

Following the FDA warning, the American Academy of Pediatrics also issued an advisory about social media trends. Some challenges, such as the ALS ice bucket challenge or the mannequin challenge, can be fun and positive activities. But medication-related challenges, such as the sleepy chicken and Benadryl challenges, can cause serious heart problems, seizures, coma, and even death.

“Teens’ brains are still developing. The part of the brain that handles rational thought, the prefrontal cortex, is not fully developed until the mid-20s,” the American Academy of Pediatrics said. “This means teens are naturally more impulsive and likely to act before thinking through all of the ramifications.”

Social media rewards outrageous behavior, it wrote, and the more outrageous the behavior, the more likely someone will get more engagement online.

“It’s a quick moving, impulsive environment, and the fear of losing out is real for teens,” the academy said. “What they will focus on is that a popular kid in class did this and got hundreds of likes and comments.”

The academy suggested that parents and guardians talk with teens about which challenges are trending on social media and at school.

“Sometimes kids are more willing to talk about their peers than themselves,” it said. “Asking questions about school trends, friends and fads may yield more answers than direct questions about their own activities.”

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

The Food and Drug Administration has issued a warning against cooking chicken in NyQuil after a social media challenge that encouraged people to try it went viral.

Called the “sleepy chicken challenge,” the trend tells people to cook chicken in NyQuil or similar over-the-counter cough and cold medications, which include ingredients such as acetaminophen, dextromethorphan, and doxylamine.

“The challenge sounds silly and unappetizing – and it is. But it could also be very unsafe,” the FDA said. “Boiling a medication can make it much more concentrated and change its properties in other ways.”

Even if someone doesn’t plan to eat the chicken, inhaling the vapors of the medication while it cooks could cause high levels of the drug to enter the body.

“It could also hurt your lungs,” the FDA said. “Put simply: Someone could take a dangerously high amount of the cough and cold medicine without even realizing it.”

This isn’t the first time that social media challenges involving medicine have gone viral. In a 2020 TikTok challenge, people were encouraged to take large doses of the allergy medicine diphenhydramine, called the “Benadryl challenge,” to cause hallucinations. The FDA received several reports of teens who were hospitalized or died, and it issued a warning about taking high doses of the drug.

“These video challenges, which often target youths, can harm people – and even cause death,” the FDA said. “Nonprescription (also called over-the-counter or OTC) drugs are readily available in many homes, making these challenges even more risky.”

In the latest warning, the FDA provided several ways for parents to make it less likely for children to do the social media challenges, such as locking up prescription and over-the-counter medications to prevent accidental overdoses. The FDA also encouraged parents and guardians to have open conversations with their children.

“Sit down with your children and discuss the dangers of misusing drugs and how social media trends can lead to real, sometimes irreversible, damage,” the FDA said. “Remind your children that overdoses can occur with OTC drugs as well as with prescription drugs.”

Following the FDA warning, the American Academy of Pediatrics also issued an advisory about social media trends. Some challenges, such as the ALS ice bucket challenge or the mannequin challenge, can be fun and positive activities. But medication-related challenges, such as the sleepy chicken and Benadryl challenges, can cause serious heart problems, seizures, coma, and even death.

“Teens’ brains are still developing. The part of the brain that handles rational thought, the prefrontal cortex, is not fully developed until the mid-20s,” the American Academy of Pediatrics said. “This means teens are naturally more impulsive and likely to act before thinking through all of the ramifications.”

Social media rewards outrageous behavior, it wrote, and the more outrageous the behavior, the more likely someone will get more engagement online.

“It’s a quick moving, impulsive environment, and the fear of losing out is real for teens,” the academy said. “What they will focus on is that a popular kid in class did this and got hundreds of likes and comments.”

The academy suggested that parents and guardians talk with teens about which challenges are trending on social media and at school.

“Sometimes kids are more willing to talk about their peers than themselves,” it said. “Asking questions about school trends, friends and fads may yield more answers than direct questions about their own activities.”

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

Tralokinumab has received a positive opinion from the European Medicine Agency’s Committee for Medicinal Products for Human Use to extend use to adolescents aged 12 years and older with moderate-to-severe atopic dermatitis (AD) who are candidates for systemic therapy, according to a statement from the manufacturer.

The positive CHMP opinion, issued on Sept. 15, recommends extending the use of tralokinumab (Adtralza), an interleukin-13 antagonist, to adolescents aged 12-17 years in the EU. The positive opinion recommends an initial dose of 600 mg administered subcutaneously followed by 300 mg every other week, the dosing recommended for adults.

In December 2021, tralokinumab was approved for adults with moderate to severe AD in the United States, where it is marketed as Adbry. It is also approved for adults in the EU, Great Britain, Canada, the United Arab Emirates, and Switzerland. It is not currently approved for treatment of adolescents in any country, according to the LEO Pharma statement.

A regulatory filing with the U.S. Food and Drug Administration is in progress, the company said, and an additional study of tralokinumab for individuals aged 12 years and older is underway, according to the manufacturer.

The CHMP opinion was supported by data from a phase 3 study (ECZTRA 6) that assessed safety and efficacy of 150-mg or 300-mg doses of tralokinumab, compared with placebo in adolescents with moderate-to-severe AD, the company statement said. The primary outcomes were an Investigator Global Assessment score of clear or almost clear skin (IGA 0/1) and an improvement of at least a 75% on the Eczema Area and Severity Index score (EASI-75). In the study, presented as a poster at a meeting in October 2021, a total of 195 adolescents aged 12-17 with moderate to severe AD who were candidates for systemic therapy were randomly assigned to tralokinumab and 94 to placebo.

At 16 weeks, 21.4% and 17.5% of patients who received 150 mg and 300 mg, respectively, of tralokinumab had IGA scores of 0 or 1, compared with 4.3% of those on placebo (P < .001, P = .002, respectively vs. placebo). In addition, 28.6% and 27.8% of the 150-mg and 300-mg tralokinumab groups, respectively, achieved EASI-75, compared with 6.4% of placebo patients (P < .001, P = .001, respectively, compared with placebo).

Adverse events were similar between the groups, and most were mild or moderate; overall safety profiles were similar to those seen in adult patients.

The European Commission will review the positive opinion and make a final decision.

The research was supported by LEO Pharma.

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

Tralokinumab has received a positive opinion from the European Medicine Agency’s Committee for Medicinal Products for Human Use to extend use to adolescents aged 12 years and older with moderate-to-severe atopic dermatitis (AD) who are candidates for systemic therapy, according to a statement from the manufacturer.

The positive CHMP opinion, issued on Sept. 15, recommends extending the use of tralokinumab (Adtralza), an interleukin-13 antagonist, to adolescents aged 12-17 years in the EU. The positive opinion recommends an initial dose of 600 mg administered subcutaneously followed by 300 mg every other week, the dosing recommended for adults.

In December 2021, tralokinumab was approved for adults with moderate to severe AD in the United States, where it is marketed as Adbry. It is also approved for adults in the EU, Great Britain, Canada, the United Arab Emirates, and Switzerland. It is not currently approved for treatment of adolescents in any country, according to the LEO Pharma statement.

A regulatory filing with the U.S. Food and Drug Administration is in progress, the company said, and an additional study of tralokinumab for individuals aged 12 years and older is underway, according to the manufacturer.

The CHMP opinion was supported by data from a phase 3 study (ECZTRA 6) that assessed safety and efficacy of 150-mg or 300-mg doses of tralokinumab, compared with placebo in adolescents with moderate-to-severe AD, the company statement said. The primary outcomes were an Investigator Global Assessment score of clear or almost clear skin (IGA 0/1) and an improvement of at least a 75% on the Eczema Area and Severity Index score (EASI-75). In the study, presented as a poster at a meeting in October 2021, a total of 195 adolescents aged 12-17 with moderate to severe AD who were candidates for systemic therapy were randomly assigned to tralokinumab and 94 to placebo.

At 16 weeks, 21.4% and 17.5% of patients who received 150 mg and 300 mg, respectively, of tralokinumab had IGA scores of 0 or 1, compared with 4.3% of those on placebo (P < .001, P = .002, respectively vs. placebo). In addition, 28.6% and 27.8% of the 150-mg and 300-mg tralokinumab groups, respectively, achieved EASI-75, compared with 6.4% of placebo patients (P < .001, P = .001, respectively, compared with placebo).

Adverse events were similar between the groups, and most were mild or moderate; overall safety profiles were similar to those seen in adult patients.

The European Commission will review the positive opinion and make a final decision.

The research was supported by LEO Pharma.

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

Tralokinumab has received a positive opinion from the European Medicine Agency’s Committee for Medicinal Products for Human Use to extend use to adolescents aged 12 years and older with moderate-to-severe atopic dermatitis (AD) who are candidates for systemic therapy, according to a statement from the manufacturer.

The positive CHMP opinion, issued on Sept. 15, recommends extending the use of tralokinumab (Adtralza), an interleukin-13 antagonist, to adolescents aged 12-17 years in the EU. The positive opinion recommends an initial dose of 600 mg administered subcutaneously followed by 300 mg every other week, the dosing recommended for adults.

In December 2021, tralokinumab was approved for adults with moderate to severe AD in the United States, where it is marketed as Adbry. It is also approved for adults in the EU, Great Britain, Canada, the United Arab Emirates, and Switzerland. It is not currently approved for treatment of adolescents in any country, according to the LEO Pharma statement.

A regulatory filing with the U.S. Food and Drug Administration is in progress, the company said, and an additional study of tralokinumab for individuals aged 12 years and older is underway, according to the manufacturer.

The CHMP opinion was supported by data from a phase 3 study (ECZTRA 6) that assessed safety and efficacy of 150-mg or 300-mg doses of tralokinumab, compared with placebo in adolescents with moderate-to-severe AD, the company statement said. The primary outcomes were an Investigator Global Assessment score of clear or almost clear skin (IGA 0/1) and an improvement of at least a 75% on the Eczema Area and Severity Index score (EASI-75). In the study, presented as a poster at a meeting in October 2021, a total of 195 adolescents aged 12-17 with moderate to severe AD who were candidates for systemic therapy were randomly assigned to tralokinumab and 94 to placebo.

At 16 weeks, 21.4% and 17.5% of patients who received 150 mg and 300 mg, respectively, of tralokinumab had IGA scores of 0 or 1, compared with 4.3% of those on placebo (P < .001, P = .002, respectively vs. placebo). In addition, 28.6% and 27.8% of the 150-mg and 300-mg tralokinumab groups, respectively, achieved EASI-75, compared with 6.4% of placebo patients (P < .001, P = .001, respectively, compared with placebo).

Adverse events were similar between the groups, and most were mild or moderate; overall safety profiles were similar to those seen in adult patients.

The European Commission will review the positive opinion and make a final decision.

The research was supported by LEO Pharma.

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