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Isotretinoin users do not have higher suicide risk: meta-analysis
.
Instead, those who are treated with the drug for severe acne may have a lower risk of suicide attempts 2-4 years after treatment, wrote the authors, led by Nicole Kye Wen Tan, MBBS, of Yong Loo Lin School of Medicine at the National University of Singapore. The results were published online in JAMA Dermatology.
The analysis showed that the 1-year absolute risk from between two and eight studies of suicide attempts, suicidal ideation, completed suicides, and self-harm were each less than 0.5%. For comparison, the absolute risk of depression was 3.83% (95% confidence interval [CI], 2.45-5.93; I2 [measuring heterogeneity] = 77%) in 11 studies.
Less likely to attempt suicide
Isotretinoin users were less likely than were nonusers to attempt suicide at 2 years (relative risk [RR], 0.92; 95% CI, 0.84-1.00; I2 = 0%); 3 years (RR, 0.86; 95% CI, 0.77-0.95; I2 = 0%); and 4 years (RR, 0.85; 95% CI, 0.72-1.00; I2 = 23%) following treatment.
Additionally, isotretinoin was not linked with the risk of “all psychiatric disorders” (RR, 1.08; 95% CI, 0.99-1.19; I2 = 0%).
Among the study limitations, the authors noted that because of the widespread claims that isotretinoin can affect mental health, it is plausible that patients at high risk of psychiatric illness were less likely to be treated with isotretinoin in the first place, which could have resulted in underestimating psychiatric risks in the observational studies.
“Two things can be true”
John S. Barbieri, MD, MBA, assistant professor at Harvard Medical School and director of the Advanced Acne Therapeutics Clinic at the Brigham and Women’s Hospital in Boston, who was not involved with this research, said the study helps confirm what he and many others have long thought.
The results of the meta-analysis show that “two things can be true, which often gets lost with isotretinoin,” he said. At a population level, isotretinoin improves mental health but on the individual level, it may cause rare side effects that harm mental health, he added.
In making decisions on the use of isotretinoin, he continued, “we should feel reassured that the likely outcome is improved mental health compared to other alternatives that we have, but at the same time we should be vigilant about monitoring a patient’s mental health while they are being treated with isotretinoin.”
He said that this topic draws extreme views on social media, with people who want the drug off the market and those who discount concerns altogether.
“I think the real answer is a little more in the middle,” he said. “We still have to be thoughtful when we use it.”
Because outcomes such as suicide in patients on isotretinoin are not common, Dr. Barbieri said, smaller studies individually have lacked precision on effect. The size of this meta-analysis helps add confidence in the results, he said.
In addition, this study can help clinicians point to numbers when they talk with their patients about benefits and risks, he said.
What a meta-analysis might miss
In an accompanying editorial, Parker Magin, PhD, of the School of Medicine and Public Health, University of Newcastle, Callaghan, New South Wales, Australia, and Shaun Prentice, PhD, of the School of Psychology, Faculty of Health and Medical Sciences at the University of Adelaide, South Australia, wrote that though the work by Tan et al. is “broadly reassuring,” they have concerns about the patients a meta-analysis might miss.
They wrote that other studies have shown evidence both of biological plausibility that isotretinoin may be linked with psychiatric effects and that it may cause these side effects. “One could conclude that it is plausible that isotretinoin has markedly adverse, idiosyncratic psychiatric effects in a small minority of individual patients,” they wrote. “It is also plausible that these presumably rare occurrences are not detectable in studies where the majority of patients experience no adverse psychiatric outcomes or even positive outcomes.”
Far from the “final word”
Dr. Magin and Dr. Prentice pointed out that while the study adds to the literature on his topic, the relationship between acne, psychiatric conditions, and isotretinoin is complex and thus these findings “are far from the final word.”
Randomized, controlled trials have limited use in this area and observational studies are always susceptible to bias, they noted. “Clinicians, though, can take some degree of further reassurance from this extension of the literature around the psychiatric sequelae of isotretinoin,” they wrote.
Senior author Hazel Oon, MD, of the National Skin Centre, Singapore, disclosed ties with AbbVie, Amgen, Boehringer Ingelheim, Eli Lilly, Galderma, Janssen, LEO Pharma, Novartis, and Pfizer. No other author disclosures were reported. Dr. Barbieri is an associate editor at JAMA Dermatology and is cochair of the American Academy of Dermatology Acne Guidelines Work Group.
.
Instead, those who are treated with the drug for severe acne may have a lower risk of suicide attempts 2-4 years after treatment, wrote the authors, led by Nicole Kye Wen Tan, MBBS, of Yong Loo Lin School of Medicine at the National University of Singapore. The results were published online in JAMA Dermatology.
The analysis showed that the 1-year absolute risk from between two and eight studies of suicide attempts, suicidal ideation, completed suicides, and self-harm were each less than 0.5%. For comparison, the absolute risk of depression was 3.83% (95% confidence interval [CI], 2.45-5.93; I2 [measuring heterogeneity] = 77%) in 11 studies.
Less likely to attempt suicide
Isotretinoin users were less likely than were nonusers to attempt suicide at 2 years (relative risk [RR], 0.92; 95% CI, 0.84-1.00; I2 = 0%); 3 years (RR, 0.86; 95% CI, 0.77-0.95; I2 = 0%); and 4 years (RR, 0.85; 95% CI, 0.72-1.00; I2 = 23%) following treatment.
Additionally, isotretinoin was not linked with the risk of “all psychiatric disorders” (RR, 1.08; 95% CI, 0.99-1.19; I2 = 0%).
Among the study limitations, the authors noted that because of the widespread claims that isotretinoin can affect mental health, it is plausible that patients at high risk of psychiatric illness were less likely to be treated with isotretinoin in the first place, which could have resulted in underestimating psychiatric risks in the observational studies.
“Two things can be true”
John S. Barbieri, MD, MBA, assistant professor at Harvard Medical School and director of the Advanced Acne Therapeutics Clinic at the Brigham and Women’s Hospital in Boston, who was not involved with this research, said the study helps confirm what he and many others have long thought.
The results of the meta-analysis show that “two things can be true, which often gets lost with isotretinoin,” he said. At a population level, isotretinoin improves mental health but on the individual level, it may cause rare side effects that harm mental health, he added.
In making decisions on the use of isotretinoin, he continued, “we should feel reassured that the likely outcome is improved mental health compared to other alternatives that we have, but at the same time we should be vigilant about monitoring a patient’s mental health while they are being treated with isotretinoin.”
He said that this topic draws extreme views on social media, with people who want the drug off the market and those who discount concerns altogether.
“I think the real answer is a little more in the middle,” he said. “We still have to be thoughtful when we use it.”
Because outcomes such as suicide in patients on isotretinoin are not common, Dr. Barbieri said, smaller studies individually have lacked precision on effect. The size of this meta-analysis helps add confidence in the results, he said.
In addition, this study can help clinicians point to numbers when they talk with their patients about benefits and risks, he said.
What a meta-analysis might miss
In an accompanying editorial, Parker Magin, PhD, of the School of Medicine and Public Health, University of Newcastle, Callaghan, New South Wales, Australia, and Shaun Prentice, PhD, of the School of Psychology, Faculty of Health and Medical Sciences at the University of Adelaide, South Australia, wrote that though the work by Tan et al. is “broadly reassuring,” they have concerns about the patients a meta-analysis might miss.
They wrote that other studies have shown evidence both of biological plausibility that isotretinoin may be linked with psychiatric effects and that it may cause these side effects. “One could conclude that it is plausible that isotretinoin has markedly adverse, idiosyncratic psychiatric effects in a small minority of individual patients,” they wrote. “It is also plausible that these presumably rare occurrences are not detectable in studies where the majority of patients experience no adverse psychiatric outcomes or even positive outcomes.”
Far from the “final word”
Dr. Magin and Dr. Prentice pointed out that while the study adds to the literature on his topic, the relationship between acne, psychiatric conditions, and isotretinoin is complex and thus these findings “are far from the final word.”
Randomized, controlled trials have limited use in this area and observational studies are always susceptible to bias, they noted. “Clinicians, though, can take some degree of further reassurance from this extension of the literature around the psychiatric sequelae of isotretinoin,” they wrote.
Senior author Hazel Oon, MD, of the National Skin Centre, Singapore, disclosed ties with AbbVie, Amgen, Boehringer Ingelheim, Eli Lilly, Galderma, Janssen, LEO Pharma, Novartis, and Pfizer. No other author disclosures were reported. Dr. Barbieri is an associate editor at JAMA Dermatology and is cochair of the American Academy of Dermatology Acne Guidelines Work Group.
.
Instead, those who are treated with the drug for severe acne may have a lower risk of suicide attempts 2-4 years after treatment, wrote the authors, led by Nicole Kye Wen Tan, MBBS, of Yong Loo Lin School of Medicine at the National University of Singapore. The results were published online in JAMA Dermatology.
The analysis showed that the 1-year absolute risk from between two and eight studies of suicide attempts, suicidal ideation, completed suicides, and self-harm were each less than 0.5%. For comparison, the absolute risk of depression was 3.83% (95% confidence interval [CI], 2.45-5.93; I2 [measuring heterogeneity] = 77%) in 11 studies.
Less likely to attempt suicide
Isotretinoin users were less likely than were nonusers to attempt suicide at 2 years (relative risk [RR], 0.92; 95% CI, 0.84-1.00; I2 = 0%); 3 years (RR, 0.86; 95% CI, 0.77-0.95; I2 = 0%); and 4 years (RR, 0.85; 95% CI, 0.72-1.00; I2 = 23%) following treatment.
Additionally, isotretinoin was not linked with the risk of “all psychiatric disorders” (RR, 1.08; 95% CI, 0.99-1.19; I2 = 0%).
Among the study limitations, the authors noted that because of the widespread claims that isotretinoin can affect mental health, it is plausible that patients at high risk of psychiatric illness were less likely to be treated with isotretinoin in the first place, which could have resulted in underestimating psychiatric risks in the observational studies.
“Two things can be true”
John S. Barbieri, MD, MBA, assistant professor at Harvard Medical School and director of the Advanced Acne Therapeutics Clinic at the Brigham and Women’s Hospital in Boston, who was not involved with this research, said the study helps confirm what he and many others have long thought.
The results of the meta-analysis show that “two things can be true, which often gets lost with isotretinoin,” he said. At a population level, isotretinoin improves mental health but on the individual level, it may cause rare side effects that harm mental health, he added.
In making decisions on the use of isotretinoin, he continued, “we should feel reassured that the likely outcome is improved mental health compared to other alternatives that we have, but at the same time we should be vigilant about monitoring a patient’s mental health while they are being treated with isotretinoin.”
He said that this topic draws extreme views on social media, with people who want the drug off the market and those who discount concerns altogether.
“I think the real answer is a little more in the middle,” he said. “We still have to be thoughtful when we use it.”
Because outcomes such as suicide in patients on isotretinoin are not common, Dr. Barbieri said, smaller studies individually have lacked precision on effect. The size of this meta-analysis helps add confidence in the results, he said.
In addition, this study can help clinicians point to numbers when they talk with their patients about benefits and risks, he said.
What a meta-analysis might miss
In an accompanying editorial, Parker Magin, PhD, of the School of Medicine and Public Health, University of Newcastle, Callaghan, New South Wales, Australia, and Shaun Prentice, PhD, of the School of Psychology, Faculty of Health and Medical Sciences at the University of Adelaide, South Australia, wrote that though the work by Tan et al. is “broadly reassuring,” they have concerns about the patients a meta-analysis might miss.
They wrote that other studies have shown evidence both of biological plausibility that isotretinoin may be linked with psychiatric effects and that it may cause these side effects. “One could conclude that it is plausible that isotretinoin has markedly adverse, idiosyncratic psychiatric effects in a small minority of individual patients,” they wrote. “It is also plausible that these presumably rare occurrences are not detectable in studies where the majority of patients experience no adverse psychiatric outcomes or even positive outcomes.”
Far from the “final word”
Dr. Magin and Dr. Prentice pointed out that while the study adds to the literature on his topic, the relationship between acne, psychiatric conditions, and isotretinoin is complex and thus these findings “are far from the final word.”
Randomized, controlled trials have limited use in this area and observational studies are always susceptible to bias, they noted. “Clinicians, though, can take some degree of further reassurance from this extension of the literature around the psychiatric sequelae of isotretinoin,” they wrote.
Senior author Hazel Oon, MD, of the National Skin Centre, Singapore, disclosed ties with AbbVie, Amgen, Boehringer Ingelheim, Eli Lilly, Galderma, Janssen, LEO Pharma, Novartis, and Pfizer. No other author disclosures were reported. Dr. Barbieri is an associate editor at JAMA Dermatology and is cochair of the American Academy of Dermatology Acne Guidelines Work Group.
FROM JAMA DERMATOLOGY
Rheumatology Match Day results for 2024 follow trends of past years
While adult rheumatology programs continue to have high match rates, pediatric rheumatology programs remain less popular.
The National Residency Matching Program (NRMP) reported on Nov. 29 that rheumatology filled 124 of 127 programs (97.6%), with 273 (98.9%) of 276 positions filled. Comparatively, pediatric rheumatology filled 21 out of 38 programs (55%) and 32 (61.5%) of 52 positions.
This year, the number of programs and positions across all specialties rose by 3%, whereas the number of applications only rose by 0.4% (35 additional applicants).
“The growth of fellowship programs and positions in the Match reflect training opportunities and the future workforce trends of medical subspecialties,” said NRMP President Donna Lamb, DHSc, MBA, BSN, in a statement. “While the increase in applicant numbers did not keep pace with the increase in positions this year, the Match rate for applicants remains strong at 82%.”
In adult rheumatology, matched applicants included 117 MD graduates, 86 foreign applicants, 38 DO graduates, and 32 U.S. citizen international medical graduates. A total of 348 applicants preferred the specialty, and 78% matched to rheumatology, whereas 2% matched to a different specialty. Another 70 applicants (20%) did not match to any program.
In pediatric rheumatology, matched applicants included 23 MD graduates, 6 DO graduates, and 3 foreign applicants. All applicants who preferred pediatric rheumatology matched to a program.
Adult rheumatology was one of several specialties that filled over 95% of positions. The other specialties that matched at that rate were allergy and immunology, cardiovascular disease, clinical cardiac electrophysiology, critical care medicine, gastroenterology, hematology and oncology, and pulmonary/critical care. Interventional Pulmonology and Oncology was the only specialty to achieve a 100% fill rate.
A version of this article first appeared on Medscape.com.
While adult rheumatology programs continue to have high match rates, pediatric rheumatology programs remain less popular.
The National Residency Matching Program (NRMP) reported on Nov. 29 that rheumatology filled 124 of 127 programs (97.6%), with 273 (98.9%) of 276 positions filled. Comparatively, pediatric rheumatology filled 21 out of 38 programs (55%) and 32 (61.5%) of 52 positions.
This year, the number of programs and positions across all specialties rose by 3%, whereas the number of applications only rose by 0.4% (35 additional applicants).
“The growth of fellowship programs and positions in the Match reflect training opportunities and the future workforce trends of medical subspecialties,” said NRMP President Donna Lamb, DHSc, MBA, BSN, in a statement. “While the increase in applicant numbers did not keep pace with the increase in positions this year, the Match rate for applicants remains strong at 82%.”
In adult rheumatology, matched applicants included 117 MD graduates, 86 foreign applicants, 38 DO graduates, and 32 U.S. citizen international medical graduates. A total of 348 applicants preferred the specialty, and 78% matched to rheumatology, whereas 2% matched to a different specialty. Another 70 applicants (20%) did not match to any program.
In pediatric rheumatology, matched applicants included 23 MD graduates, 6 DO graduates, and 3 foreign applicants. All applicants who preferred pediatric rheumatology matched to a program.
Adult rheumatology was one of several specialties that filled over 95% of positions. The other specialties that matched at that rate were allergy and immunology, cardiovascular disease, clinical cardiac electrophysiology, critical care medicine, gastroenterology, hematology and oncology, and pulmonary/critical care. Interventional Pulmonology and Oncology was the only specialty to achieve a 100% fill rate.
A version of this article first appeared on Medscape.com.
While adult rheumatology programs continue to have high match rates, pediatric rheumatology programs remain less popular.
The National Residency Matching Program (NRMP) reported on Nov. 29 that rheumatology filled 124 of 127 programs (97.6%), with 273 (98.9%) of 276 positions filled. Comparatively, pediatric rheumatology filled 21 out of 38 programs (55%) and 32 (61.5%) of 52 positions.
This year, the number of programs and positions across all specialties rose by 3%, whereas the number of applications only rose by 0.4% (35 additional applicants).
“The growth of fellowship programs and positions in the Match reflect training opportunities and the future workforce trends of medical subspecialties,” said NRMP President Donna Lamb, DHSc, MBA, BSN, in a statement. “While the increase in applicant numbers did not keep pace with the increase in positions this year, the Match rate for applicants remains strong at 82%.”
In adult rheumatology, matched applicants included 117 MD graduates, 86 foreign applicants, 38 DO graduates, and 32 U.S. citizen international medical graduates. A total of 348 applicants preferred the specialty, and 78% matched to rheumatology, whereas 2% matched to a different specialty. Another 70 applicants (20%) did not match to any program.
In pediatric rheumatology, matched applicants included 23 MD graduates, 6 DO graduates, and 3 foreign applicants. All applicants who preferred pediatric rheumatology matched to a program.
Adult rheumatology was one of several specialties that filled over 95% of positions. The other specialties that matched at that rate were allergy and immunology, cardiovascular disease, clinical cardiac electrophysiology, critical care medicine, gastroenterology, hematology and oncology, and pulmonary/critical care. Interventional Pulmonology and Oncology was the only specialty to achieve a 100% fill rate.
A version of this article first appeared on Medscape.com.
Laser epilation may reduce pilonidal disease recurrences when added to standard care
according to the results of a randomized trial.
The study, recently published in JAMA Surgery, enrolled 302 patients ages 11-21 with pilonidal disease. Half of the participants were assigned to receive LE (laser hair removal) plus standard treatment (improved hygiene plus mechanical or chemical hair removal), and half were assigned to receive standard care alone.
At 1 year, 10.4% of the patients who had received LE plus standard treatment had experienced a recurrence of pilonidal disease, compared with 33.6% of patients in the standard treatment group (P < .001). Rates were based on the data available on 96 patients in the LE group and 134 patients in the standard care group.
“These results provide further evidence that laser epilation is safe, well-tolerated, and should be available as an initial treatment option or adjunct treatment modality for all eligible patients,” first author Peter C. Minneci, MD, chair of surgery at Nemours Children’s Health, Delaware Valley, Wilmington, Del, said in a press release reporting the results. “There have been few comparative studies that have investigated recurrence rates after LE versus other treatment modalities,” he and his coauthors wrote in the study, noting that the study “was the first, to our knowledge, to compare LE as an adjunct to standard care versus standard care alone and demonstrate a decrease in recurrence rates.”
Pilonidal disease, a common condition, results when cysts form between the buttocks and is most common in adolescents and young adults. It is thought to recur about 33% of the time, with most cases recurring within 1 year of treatment.
In practice, there are large variations in management strategies for pilonidal disease because evidence for an ideal treatment approach is lacking, Dr. Minneci and coauthors wrote. Although lifestyle modifications and nonepilation hair removal strategies have been linked to a reduced need for surgery, compliance with these strategies is low. Additionally, recurrence contributes to “a high degree of psychosocial stress in patients, who often miss school or sports and may avoid social activities,” Dr. Minneci said in the press release. Therefore, some practitioners have begun using LE – which uses selective thermolysis to remove the hair shaft, follicle, and bulb – as an adjunct to standard treatments in the hopes of avoiding surgery.
A few studies have shown LE is effective in reducing pilonidal disease recurrence, but these studies had small sample sizes, according to the authors.
Study methods
The randomized, nonblinded clinical trial was conducted between 2017 and 2022 at Nationwide Children’s Hospital, Columbus, and enrolled patients aged 11-21 years with a history of pilonidal disease, who did not have active disease.
Those in the control group (151 patients) had an in-person clinic visit where they received education and training about hair removal in the gluteal cleft, and were provided with supplies for hair removal (chemical epilation or shaving) for 6 months (standard of care). Those in the LE group (151 patients) received standard of care therapy, and also received one LE treatment every 4-6 weeks for a total of five treatments. They were encouraged to perform hair removal using chemical or mechanical depilation between visits.
At the 1-year follow-up, data were available in 96 patients in the LE group and 134 patients in the standard care group. At that time, the proportion of those who had a recurrence within 1 year was significantly lower in the LE group than in the standard care group (mean difference, –23.2%; 95% CI, –33.2% to –13.1%; P < .001).
In addition, over the course of a year, those in the LE-treated group had significantly higher Child Attitude Toward Illness scores, indicating that they felt more positively about their illness at 6 months than participants in the standard care group. There were no differences between the groups in terms of patient or caregiver disability days, patient- or caregiver-reported health-related quality of life, health care satisfaction, or perceived stigma. In the LE group, no burns were reported, and no inability to tolerate treatment because of pain.
The study had several limitations, including the potential for participation bias, and because of a loss to follow-up, primary and secondary outcomes were missing data points, which was higher in the LE group. Loss to follow-up in the LE arm increased after 6 months, when laser treatments ended, with many of those patients not completing surveys at 9 and 12 months. The hospital’s pilonidal clinic shut down for 3 months during the COVID-19 pandemic, and when the clinic reopened, 15 patients in the LE arm withdrew from the study.
|In the press release, Dr. Minneci said that confirmation of the effectiveness of LE could help justify insurance coverage for pilonidal disease, noting that LE is usually not covered with insurance, and a course of treatment could cost $800-$1,500.
Dr. Minneci and four of the other six coauthors reported receiving grants from Patient-Centered Outcomes Research Institute during the conduct of the study. One author reported receiving grants from the National Institute on Minority Health and Health Disparities outside the submitted work. The research was funded by a grant from the Patient-Centered Outcomes Research Institute.
according to the results of a randomized trial.
The study, recently published in JAMA Surgery, enrolled 302 patients ages 11-21 with pilonidal disease. Half of the participants were assigned to receive LE (laser hair removal) plus standard treatment (improved hygiene plus mechanical or chemical hair removal), and half were assigned to receive standard care alone.
At 1 year, 10.4% of the patients who had received LE plus standard treatment had experienced a recurrence of pilonidal disease, compared with 33.6% of patients in the standard treatment group (P < .001). Rates were based on the data available on 96 patients in the LE group and 134 patients in the standard care group.
“These results provide further evidence that laser epilation is safe, well-tolerated, and should be available as an initial treatment option or adjunct treatment modality for all eligible patients,” first author Peter C. Minneci, MD, chair of surgery at Nemours Children’s Health, Delaware Valley, Wilmington, Del, said in a press release reporting the results. “There have been few comparative studies that have investigated recurrence rates after LE versus other treatment modalities,” he and his coauthors wrote in the study, noting that the study “was the first, to our knowledge, to compare LE as an adjunct to standard care versus standard care alone and demonstrate a decrease in recurrence rates.”
Pilonidal disease, a common condition, results when cysts form between the buttocks and is most common in adolescents and young adults. It is thought to recur about 33% of the time, with most cases recurring within 1 year of treatment.
In practice, there are large variations in management strategies for pilonidal disease because evidence for an ideal treatment approach is lacking, Dr. Minneci and coauthors wrote. Although lifestyle modifications and nonepilation hair removal strategies have been linked to a reduced need for surgery, compliance with these strategies is low. Additionally, recurrence contributes to “a high degree of psychosocial stress in patients, who often miss school or sports and may avoid social activities,” Dr. Minneci said in the press release. Therefore, some practitioners have begun using LE – which uses selective thermolysis to remove the hair shaft, follicle, and bulb – as an adjunct to standard treatments in the hopes of avoiding surgery.
A few studies have shown LE is effective in reducing pilonidal disease recurrence, but these studies had small sample sizes, according to the authors.
Study methods
The randomized, nonblinded clinical trial was conducted between 2017 and 2022 at Nationwide Children’s Hospital, Columbus, and enrolled patients aged 11-21 years with a history of pilonidal disease, who did not have active disease.
Those in the control group (151 patients) had an in-person clinic visit where they received education and training about hair removal in the gluteal cleft, and were provided with supplies for hair removal (chemical epilation or shaving) for 6 months (standard of care). Those in the LE group (151 patients) received standard of care therapy, and also received one LE treatment every 4-6 weeks for a total of five treatments. They were encouraged to perform hair removal using chemical or mechanical depilation between visits.
At the 1-year follow-up, data were available in 96 patients in the LE group and 134 patients in the standard care group. At that time, the proportion of those who had a recurrence within 1 year was significantly lower in the LE group than in the standard care group (mean difference, –23.2%; 95% CI, –33.2% to –13.1%; P < .001).
In addition, over the course of a year, those in the LE-treated group had significantly higher Child Attitude Toward Illness scores, indicating that they felt more positively about their illness at 6 months than participants in the standard care group. There were no differences between the groups in terms of patient or caregiver disability days, patient- or caregiver-reported health-related quality of life, health care satisfaction, or perceived stigma. In the LE group, no burns were reported, and no inability to tolerate treatment because of pain.
The study had several limitations, including the potential for participation bias, and because of a loss to follow-up, primary and secondary outcomes were missing data points, which was higher in the LE group. Loss to follow-up in the LE arm increased after 6 months, when laser treatments ended, with many of those patients not completing surveys at 9 and 12 months. The hospital’s pilonidal clinic shut down for 3 months during the COVID-19 pandemic, and when the clinic reopened, 15 patients in the LE arm withdrew from the study.
|In the press release, Dr. Minneci said that confirmation of the effectiveness of LE could help justify insurance coverage for pilonidal disease, noting that LE is usually not covered with insurance, and a course of treatment could cost $800-$1,500.
Dr. Minneci and four of the other six coauthors reported receiving grants from Patient-Centered Outcomes Research Institute during the conduct of the study. One author reported receiving grants from the National Institute on Minority Health and Health Disparities outside the submitted work. The research was funded by a grant from the Patient-Centered Outcomes Research Institute.
according to the results of a randomized trial.
The study, recently published in JAMA Surgery, enrolled 302 patients ages 11-21 with pilonidal disease. Half of the participants were assigned to receive LE (laser hair removal) plus standard treatment (improved hygiene plus mechanical or chemical hair removal), and half were assigned to receive standard care alone.
At 1 year, 10.4% of the patients who had received LE plus standard treatment had experienced a recurrence of pilonidal disease, compared with 33.6% of patients in the standard treatment group (P < .001). Rates were based on the data available on 96 patients in the LE group and 134 patients in the standard care group.
“These results provide further evidence that laser epilation is safe, well-tolerated, and should be available as an initial treatment option or adjunct treatment modality for all eligible patients,” first author Peter C. Minneci, MD, chair of surgery at Nemours Children’s Health, Delaware Valley, Wilmington, Del, said in a press release reporting the results. “There have been few comparative studies that have investigated recurrence rates after LE versus other treatment modalities,” he and his coauthors wrote in the study, noting that the study “was the first, to our knowledge, to compare LE as an adjunct to standard care versus standard care alone and demonstrate a decrease in recurrence rates.”
Pilonidal disease, a common condition, results when cysts form between the buttocks and is most common in adolescents and young adults. It is thought to recur about 33% of the time, with most cases recurring within 1 year of treatment.
In practice, there are large variations in management strategies for pilonidal disease because evidence for an ideal treatment approach is lacking, Dr. Minneci and coauthors wrote. Although lifestyle modifications and nonepilation hair removal strategies have been linked to a reduced need for surgery, compliance with these strategies is low. Additionally, recurrence contributes to “a high degree of psychosocial stress in patients, who often miss school or sports and may avoid social activities,” Dr. Minneci said in the press release. Therefore, some practitioners have begun using LE – which uses selective thermolysis to remove the hair shaft, follicle, and bulb – as an adjunct to standard treatments in the hopes of avoiding surgery.
A few studies have shown LE is effective in reducing pilonidal disease recurrence, but these studies had small sample sizes, according to the authors.
Study methods
The randomized, nonblinded clinical trial was conducted between 2017 and 2022 at Nationwide Children’s Hospital, Columbus, and enrolled patients aged 11-21 years with a history of pilonidal disease, who did not have active disease.
Those in the control group (151 patients) had an in-person clinic visit where they received education and training about hair removal in the gluteal cleft, and were provided with supplies for hair removal (chemical epilation or shaving) for 6 months (standard of care). Those in the LE group (151 patients) received standard of care therapy, and also received one LE treatment every 4-6 weeks for a total of five treatments. They were encouraged to perform hair removal using chemical or mechanical depilation between visits.
At the 1-year follow-up, data were available in 96 patients in the LE group and 134 patients in the standard care group. At that time, the proportion of those who had a recurrence within 1 year was significantly lower in the LE group than in the standard care group (mean difference, –23.2%; 95% CI, –33.2% to –13.1%; P < .001).
In addition, over the course of a year, those in the LE-treated group had significantly higher Child Attitude Toward Illness scores, indicating that they felt more positively about their illness at 6 months than participants in the standard care group. There were no differences between the groups in terms of patient or caregiver disability days, patient- or caregiver-reported health-related quality of life, health care satisfaction, or perceived stigma. In the LE group, no burns were reported, and no inability to tolerate treatment because of pain.
The study had several limitations, including the potential for participation bias, and because of a loss to follow-up, primary and secondary outcomes were missing data points, which was higher in the LE group. Loss to follow-up in the LE arm increased after 6 months, when laser treatments ended, with many of those patients not completing surveys at 9 and 12 months. The hospital’s pilonidal clinic shut down for 3 months during the COVID-19 pandemic, and when the clinic reopened, 15 patients in the LE arm withdrew from the study.
|In the press release, Dr. Minneci said that confirmation of the effectiveness of LE could help justify insurance coverage for pilonidal disease, noting that LE is usually not covered with insurance, and a course of treatment could cost $800-$1,500.
Dr. Minneci and four of the other six coauthors reported receiving grants from Patient-Centered Outcomes Research Institute during the conduct of the study. One author reported receiving grants from the National Institute on Minority Health and Health Disparities outside the submitted work. The research was funded by a grant from the Patient-Centered Outcomes Research Institute.
FROM JAMA SURGERY
Novel approach curbs the impact of racism on mental health in Black youth
TOPLINE:
, results of a post hoc analysis of a randomized controlled trial show.
METHODOLOGY:
- SAAF is a 7-week family skills training program delivered at local community centers that targets effective parenting behavior, adolescent self-regulation, and Black pride.
- In the original trial, 472 Black children aged 11-12 years were randomly allocated to SAAF or no treatment control.
- The post hoc analysis investigated changes in adolescent-reported depressive symptoms from age 13 to 14 years using the 20-item Center for Epidemiologic Studies Depression Scale for Children.
TAKEAWAY:
- Exposure to racial discrimination at age 13 years correlated with increased depressive symptoms at age 14 years (P < .001).
- Participation in the SAAF program significantly attenuated the association of racial discrimination at age 13 with increases in depressive symptoms at age 14 (P = .01).
- Racial discrimination was significantly associated with increases in depressive symptoms in the control group (P < .001) but not in the SAAF group.
- This moderating effect was observed using intent-to-treat design; the investigators accounted for family socioeconomic disadvantage and youth gender.
IN PRACTICE:
The findings add to other evidence suggesting that “prevention programs targeting aspects of racial identity, racial socialization processes, and parenting behavior may, to some extent, mitigate the mental health effects associated with racial discrimination. These processes appear to increase positive coping in the aftermath of discrimination, and prevent adolescents internalization of toxic messages regarding racial inferiority,” the authors wrote.
SOURCE:
The study, with first author Steven M. Kogan, PhD, University of Georgia in Athens, was published online in JAMA Network Open with a commentary by Kevin M. Simon, MD, MPH, with Boston Children’s Hospital.
LIMITATIONS:
This was a post hoc analysis of trial data. The sample consisted of Black adolescents from rural areas of Georgia, and the results may not be generalizable to Black adolescents from urban areas or adolescents from other racial groups. Because of the study’s focus on individual-level racial discrimination, the potential for SAAF to buffer the effects of structural and institutional forms of racism is unknown.
DISCLOSURES:
The study had no specific funding. The authors have disclosed no relevant conflicts of interest.
A version of this article first appeared on Medscape.com.
TOPLINE:
, results of a post hoc analysis of a randomized controlled trial show.
METHODOLOGY:
- SAAF is a 7-week family skills training program delivered at local community centers that targets effective parenting behavior, adolescent self-regulation, and Black pride.
- In the original trial, 472 Black children aged 11-12 years were randomly allocated to SAAF or no treatment control.
- The post hoc analysis investigated changes in adolescent-reported depressive symptoms from age 13 to 14 years using the 20-item Center for Epidemiologic Studies Depression Scale for Children.
TAKEAWAY:
- Exposure to racial discrimination at age 13 years correlated with increased depressive symptoms at age 14 years (P < .001).
- Participation in the SAAF program significantly attenuated the association of racial discrimination at age 13 with increases in depressive symptoms at age 14 (P = .01).
- Racial discrimination was significantly associated with increases in depressive symptoms in the control group (P < .001) but not in the SAAF group.
- This moderating effect was observed using intent-to-treat design; the investigators accounted for family socioeconomic disadvantage and youth gender.
IN PRACTICE:
The findings add to other evidence suggesting that “prevention programs targeting aspects of racial identity, racial socialization processes, and parenting behavior may, to some extent, mitigate the mental health effects associated with racial discrimination. These processes appear to increase positive coping in the aftermath of discrimination, and prevent adolescents internalization of toxic messages regarding racial inferiority,” the authors wrote.
SOURCE:
The study, with first author Steven M. Kogan, PhD, University of Georgia in Athens, was published online in JAMA Network Open with a commentary by Kevin M. Simon, MD, MPH, with Boston Children’s Hospital.
LIMITATIONS:
This was a post hoc analysis of trial data. The sample consisted of Black adolescents from rural areas of Georgia, and the results may not be generalizable to Black adolescents from urban areas or adolescents from other racial groups. Because of the study’s focus on individual-level racial discrimination, the potential for SAAF to buffer the effects of structural and institutional forms of racism is unknown.
DISCLOSURES:
The study had no specific funding. The authors have disclosed no relevant conflicts of interest.
A version of this article first appeared on Medscape.com.
TOPLINE:
, results of a post hoc analysis of a randomized controlled trial show.
METHODOLOGY:
- SAAF is a 7-week family skills training program delivered at local community centers that targets effective parenting behavior, adolescent self-regulation, and Black pride.
- In the original trial, 472 Black children aged 11-12 years were randomly allocated to SAAF or no treatment control.
- The post hoc analysis investigated changes in adolescent-reported depressive symptoms from age 13 to 14 years using the 20-item Center for Epidemiologic Studies Depression Scale for Children.
TAKEAWAY:
- Exposure to racial discrimination at age 13 years correlated with increased depressive symptoms at age 14 years (P < .001).
- Participation in the SAAF program significantly attenuated the association of racial discrimination at age 13 with increases in depressive symptoms at age 14 (P = .01).
- Racial discrimination was significantly associated with increases in depressive symptoms in the control group (P < .001) but not in the SAAF group.
- This moderating effect was observed using intent-to-treat design; the investigators accounted for family socioeconomic disadvantage and youth gender.
IN PRACTICE:
The findings add to other evidence suggesting that “prevention programs targeting aspects of racial identity, racial socialization processes, and parenting behavior may, to some extent, mitigate the mental health effects associated with racial discrimination. These processes appear to increase positive coping in the aftermath of discrimination, and prevent adolescents internalization of toxic messages regarding racial inferiority,” the authors wrote.
SOURCE:
The study, with first author Steven M. Kogan, PhD, University of Georgia in Athens, was published online in JAMA Network Open with a commentary by Kevin M. Simon, MD, MPH, with Boston Children’s Hospital.
LIMITATIONS:
This was a post hoc analysis of trial data. The sample consisted of Black adolescents from rural areas of Georgia, and the results may not be generalizable to Black adolescents from urban areas or adolescents from other racial groups. Because of the study’s focus on individual-level racial discrimination, the potential for SAAF to buffer the effects of structural and institutional forms of racism is unknown.
DISCLOSURES:
The study had no specific funding. The authors have disclosed no relevant conflicts of interest.
A version of this article first appeared on Medscape.com.
New drug reporting limit may overlook cannabis in children
TOPLINE:
, according to a research letter published online in JAMA Pediatrics.
METHODOLOGY:
- After a laboratory changed its reporting threshold for the metabolite 11-nor-9-carboxy-Δ9-tetrahydrocannabinol (THC-COOH) from 5 ng/mL to 15 ng/mL in 2019 to match federal standards, researchers examined the rate of false positives for the initial urine drug screen and the false-negative rate with LC-MS.
- Their study focused on 976 cannabinoid-positive drug screens conducted at a pediatric hospital between Nov. 18, 2019, and May 31, 2021, that had confirmatory LC-MS to rule out false-positive results.
- Patients had a median age of 16 years.
TAKEAWAY:
- The false-positive rate was 10.1% based on the 15 ng/mL threshold compared with 2% based on the 5 ng/mL limit of quantification.
- About 81% of samples with negative LC-MS reports had detectable concentrations of THC-COOH.
IN PRACTICE:
“Confirming THC-COOH in children’s and adolescents’ urine may be relevant at concentrations less than 15 ng/mL, particularly if child protection is pertinent,” according to the study authors.
“Confirmatory testing should be reserved for select cases and must be interpreted with caution,” they added. “Laboratories should report down to the limit of quantification on request.”
SOURCE:
Christopher J. Watson, MD, emergency medicine physician, Maine Medical Center, Portland, is the study’s corresponding author.
LIMITATIONS:
The researchers lacked information about the clinical context in which patients underwent drug screening.
DISCLOSURES:
A coauthor disclosed royalties from UpToDate outside of the study.
A version of this article appeared on Medscape.com.
TOPLINE:
, according to a research letter published online in JAMA Pediatrics.
METHODOLOGY:
- After a laboratory changed its reporting threshold for the metabolite 11-nor-9-carboxy-Δ9-tetrahydrocannabinol (THC-COOH) from 5 ng/mL to 15 ng/mL in 2019 to match federal standards, researchers examined the rate of false positives for the initial urine drug screen and the false-negative rate with LC-MS.
- Their study focused on 976 cannabinoid-positive drug screens conducted at a pediatric hospital between Nov. 18, 2019, and May 31, 2021, that had confirmatory LC-MS to rule out false-positive results.
- Patients had a median age of 16 years.
TAKEAWAY:
- The false-positive rate was 10.1% based on the 15 ng/mL threshold compared with 2% based on the 5 ng/mL limit of quantification.
- About 81% of samples with negative LC-MS reports had detectable concentrations of THC-COOH.
IN PRACTICE:
“Confirming THC-COOH in children’s and adolescents’ urine may be relevant at concentrations less than 15 ng/mL, particularly if child protection is pertinent,” according to the study authors.
“Confirmatory testing should be reserved for select cases and must be interpreted with caution,” they added. “Laboratories should report down to the limit of quantification on request.”
SOURCE:
Christopher J. Watson, MD, emergency medicine physician, Maine Medical Center, Portland, is the study’s corresponding author.
LIMITATIONS:
The researchers lacked information about the clinical context in which patients underwent drug screening.
DISCLOSURES:
A coauthor disclosed royalties from UpToDate outside of the study.
A version of this article appeared on Medscape.com.
TOPLINE:
, according to a research letter published online in JAMA Pediatrics.
METHODOLOGY:
- After a laboratory changed its reporting threshold for the metabolite 11-nor-9-carboxy-Δ9-tetrahydrocannabinol (THC-COOH) from 5 ng/mL to 15 ng/mL in 2019 to match federal standards, researchers examined the rate of false positives for the initial urine drug screen and the false-negative rate with LC-MS.
- Their study focused on 976 cannabinoid-positive drug screens conducted at a pediatric hospital between Nov. 18, 2019, and May 31, 2021, that had confirmatory LC-MS to rule out false-positive results.
- Patients had a median age of 16 years.
TAKEAWAY:
- The false-positive rate was 10.1% based on the 15 ng/mL threshold compared with 2% based on the 5 ng/mL limit of quantification.
- About 81% of samples with negative LC-MS reports had detectable concentrations of THC-COOH.
IN PRACTICE:
“Confirming THC-COOH in children’s and adolescents’ urine may be relevant at concentrations less than 15 ng/mL, particularly if child protection is pertinent,” according to the study authors.
“Confirmatory testing should be reserved for select cases and must be interpreted with caution,” they added. “Laboratories should report down to the limit of quantification on request.”
SOURCE:
Christopher J. Watson, MD, emergency medicine physician, Maine Medical Center, Portland, is the study’s corresponding author.
LIMITATIONS:
The researchers lacked information about the clinical context in which patients underwent drug screening.
DISCLOSURES:
A coauthor disclosed royalties from UpToDate outside of the study.
A version of this article appeared on Medscape.com.
U.S. kids are taking melatonin for sleep, despite evidence gap
according to a recent study.
These findings should prompt clinicians to discuss with parents the various factors that could be driving sleep disturbances, and potential safety issues associated with melatonin usage, lead author Lauren E. Hartstein, PhD, a postdoctoral fellow in the Sleep and Development Lab at the University of Colorado, Boulder, and colleagues reported.
Writing in JAMA Pediatrics, the investigators noted that melatonin products are notorious for mislabeling, with active ingredient quantities as much as three times higher than the labeled amount. This issue is particularly concerning, they added, as calls to poison control for melatonin ingestion jumped more than fivefold from 2012 to 2021, with most cases involving children younger than 5 years. Meanwhile, scant evidence is available to characterize intentional usage in the same population.
“Current data are lacking on the prevalence of melatonin use and the frequency, dosing, and timing of melatonin administration in U.S. youth,” Dr. Hartstein and colleagues wrote.
To address this knowledge gap, the investigators conducted an online survey of parents with children and adolescents aged 1.0-13.9 years. The survey asked parents to report any melatonin usage in their children in the past 30 days.
Parents reporting melatonin usage were asked about frequency, dose, timing of administration before bedtime, and duration of use.
Findings were reported within three age groups: preschool (1-4 years), school aged (5-9 years), and preteen (10-13 years).
The survey revealed that almost one in five children in the older age groups were using melatonin, with a rate of 18.5% in the school-aged group and 19.4% in the preteen group. In comparison, 5.6% of preschool children had received melatonin for sleep in the past 30 days.
A significant uptick in usage
These findings point to a significant uptick in usage, according to Dr. Hartstein and colleagues, who cited a 2017-2018 study that found just 1.3% of U.S. children had taken melatonin in the past 30 days.
In the present study, melatonin was typically administered 30 minutes before bedtime, most often as a gummy (64.3%) or chewable tablet (27.0%).
Frequency of administration was similar between age groups and trended toward a bimodal pattern, with melatonin often given either 1 day per week or 7 days per week.
Median dose increased significantly with age, from 0.5 mg in the preschool group to 1.0 mg in the school-aged group and 2.0 mg in the preteen group. Median duration also showed a significant upward trend, with 12-month, 18-month, and 21-month durations, respectively, for ascending age groups.
The investigators concluded that melatonin usage among U.S. adolescents and children is “exceedingly common,” despite a lack of evidence to support long-term safety or guide optimal dosing.
Is melatonin use masking other sleep issues?
“Widespread melatonin use across developmental stages may suggest a high prevalence of sleep disruption, which deserves accurate diagnosis and effective treatment,” Dr. Hartstein and colleagues wrote. “Dissemination of information regarding safety concerns, such as overdose and supplement mislabeling, is necessary. Clinicians should discuss with parents the factors associated with sleep difficulties and effective behavioral strategies.”
Large-scale, long-term studies are needed, they added, to generate relevant safety and efficacy data, and to characterize the factors driving melatonin administration by parents.
“Studies like these add to our knowledge base and give us insight into what patients or parents may be doing that can impact overall health,” said Alfonso J. Padilla, MD, assistant clinical professor of sleep medicine at the University of California, Los Angeles, in a written comment. “Often, in normal encounters with our patients we may not be able to gather this information easily. It may help open conversations about sleep issues that are not being addressed.”
Dr. Padilla suggested that parents may believe that melatonin is safe because it is not regulated by the Food and Drug Administration, when in fact they could be negatively impacting their children’s sleep. He noted that short-term risks include altered circadian rhythm and vivid dreams or nightmares, while long-term safety remains unclear.
“As a sleep physician, I use melatonin for specific indications only,” Dr. Padilla said. “I may use it in small children that are having difficulty falling asleep, especially in children with autism or special needs. I also use it for help in adjustment in circadian rhythm, especially in adolescents.”
He recommends melatonin, he added, if he has a complete case history, and melatonin is suitable for that patient.
Typically, it’s not.
“Most often a medication is not the answer for the sleep concern that parents are having about their child,” he said.
The investigators disclosed grants from the Eunice Kennedy Shriver National Institute of Child Health and Human Development and the Colorado Clinical and Translational Science Award Program of the National Center for Advancing Translational Sciences of the National Institutes of Health. They reported no conflicts of interest.
according to a recent study.
These findings should prompt clinicians to discuss with parents the various factors that could be driving sleep disturbances, and potential safety issues associated with melatonin usage, lead author Lauren E. Hartstein, PhD, a postdoctoral fellow in the Sleep and Development Lab at the University of Colorado, Boulder, and colleagues reported.
Writing in JAMA Pediatrics, the investigators noted that melatonin products are notorious for mislabeling, with active ingredient quantities as much as three times higher than the labeled amount. This issue is particularly concerning, they added, as calls to poison control for melatonin ingestion jumped more than fivefold from 2012 to 2021, with most cases involving children younger than 5 years. Meanwhile, scant evidence is available to characterize intentional usage in the same population.
“Current data are lacking on the prevalence of melatonin use and the frequency, dosing, and timing of melatonin administration in U.S. youth,” Dr. Hartstein and colleagues wrote.
To address this knowledge gap, the investigators conducted an online survey of parents with children and adolescents aged 1.0-13.9 years. The survey asked parents to report any melatonin usage in their children in the past 30 days.
Parents reporting melatonin usage were asked about frequency, dose, timing of administration before bedtime, and duration of use.
Findings were reported within three age groups: preschool (1-4 years), school aged (5-9 years), and preteen (10-13 years).
The survey revealed that almost one in five children in the older age groups were using melatonin, with a rate of 18.5% in the school-aged group and 19.4% in the preteen group. In comparison, 5.6% of preschool children had received melatonin for sleep in the past 30 days.
A significant uptick in usage
These findings point to a significant uptick in usage, according to Dr. Hartstein and colleagues, who cited a 2017-2018 study that found just 1.3% of U.S. children had taken melatonin in the past 30 days.
In the present study, melatonin was typically administered 30 minutes before bedtime, most often as a gummy (64.3%) or chewable tablet (27.0%).
Frequency of administration was similar between age groups and trended toward a bimodal pattern, with melatonin often given either 1 day per week or 7 days per week.
Median dose increased significantly with age, from 0.5 mg in the preschool group to 1.0 mg in the school-aged group and 2.0 mg in the preteen group. Median duration also showed a significant upward trend, with 12-month, 18-month, and 21-month durations, respectively, for ascending age groups.
The investigators concluded that melatonin usage among U.S. adolescents and children is “exceedingly common,” despite a lack of evidence to support long-term safety or guide optimal dosing.
Is melatonin use masking other sleep issues?
“Widespread melatonin use across developmental stages may suggest a high prevalence of sleep disruption, which deserves accurate diagnosis and effective treatment,” Dr. Hartstein and colleagues wrote. “Dissemination of information regarding safety concerns, such as overdose and supplement mislabeling, is necessary. Clinicians should discuss with parents the factors associated with sleep difficulties and effective behavioral strategies.”
Large-scale, long-term studies are needed, they added, to generate relevant safety and efficacy data, and to characterize the factors driving melatonin administration by parents.
“Studies like these add to our knowledge base and give us insight into what patients or parents may be doing that can impact overall health,” said Alfonso J. Padilla, MD, assistant clinical professor of sleep medicine at the University of California, Los Angeles, in a written comment. “Often, in normal encounters with our patients we may not be able to gather this information easily. It may help open conversations about sleep issues that are not being addressed.”
Dr. Padilla suggested that parents may believe that melatonin is safe because it is not regulated by the Food and Drug Administration, when in fact they could be negatively impacting their children’s sleep. He noted that short-term risks include altered circadian rhythm and vivid dreams or nightmares, while long-term safety remains unclear.
“As a sleep physician, I use melatonin for specific indications only,” Dr. Padilla said. “I may use it in small children that are having difficulty falling asleep, especially in children with autism or special needs. I also use it for help in adjustment in circadian rhythm, especially in adolescents.”
He recommends melatonin, he added, if he has a complete case history, and melatonin is suitable for that patient.
Typically, it’s not.
“Most often a medication is not the answer for the sleep concern that parents are having about their child,” he said.
The investigators disclosed grants from the Eunice Kennedy Shriver National Institute of Child Health and Human Development and the Colorado Clinical and Translational Science Award Program of the National Center for Advancing Translational Sciences of the National Institutes of Health. They reported no conflicts of interest.
according to a recent study.
These findings should prompt clinicians to discuss with parents the various factors that could be driving sleep disturbances, and potential safety issues associated with melatonin usage, lead author Lauren E. Hartstein, PhD, a postdoctoral fellow in the Sleep and Development Lab at the University of Colorado, Boulder, and colleagues reported.
Writing in JAMA Pediatrics, the investigators noted that melatonin products are notorious for mislabeling, with active ingredient quantities as much as three times higher than the labeled amount. This issue is particularly concerning, they added, as calls to poison control for melatonin ingestion jumped more than fivefold from 2012 to 2021, with most cases involving children younger than 5 years. Meanwhile, scant evidence is available to characterize intentional usage in the same population.
“Current data are lacking on the prevalence of melatonin use and the frequency, dosing, and timing of melatonin administration in U.S. youth,” Dr. Hartstein and colleagues wrote.
To address this knowledge gap, the investigators conducted an online survey of parents with children and adolescents aged 1.0-13.9 years. The survey asked parents to report any melatonin usage in their children in the past 30 days.
Parents reporting melatonin usage were asked about frequency, dose, timing of administration before bedtime, and duration of use.
Findings were reported within three age groups: preschool (1-4 years), school aged (5-9 years), and preteen (10-13 years).
The survey revealed that almost one in five children in the older age groups were using melatonin, with a rate of 18.5% in the school-aged group and 19.4% in the preteen group. In comparison, 5.6% of preschool children had received melatonin for sleep in the past 30 days.
A significant uptick in usage
These findings point to a significant uptick in usage, according to Dr. Hartstein and colleagues, who cited a 2017-2018 study that found just 1.3% of U.S. children had taken melatonin in the past 30 days.
In the present study, melatonin was typically administered 30 minutes before bedtime, most often as a gummy (64.3%) or chewable tablet (27.0%).
Frequency of administration was similar between age groups and trended toward a bimodal pattern, with melatonin often given either 1 day per week or 7 days per week.
Median dose increased significantly with age, from 0.5 mg in the preschool group to 1.0 mg in the school-aged group and 2.0 mg in the preteen group. Median duration also showed a significant upward trend, with 12-month, 18-month, and 21-month durations, respectively, for ascending age groups.
The investigators concluded that melatonin usage among U.S. adolescents and children is “exceedingly common,” despite a lack of evidence to support long-term safety or guide optimal dosing.
Is melatonin use masking other sleep issues?
“Widespread melatonin use across developmental stages may suggest a high prevalence of sleep disruption, which deserves accurate diagnosis and effective treatment,” Dr. Hartstein and colleagues wrote. “Dissemination of information regarding safety concerns, such as overdose and supplement mislabeling, is necessary. Clinicians should discuss with parents the factors associated with sleep difficulties and effective behavioral strategies.”
Large-scale, long-term studies are needed, they added, to generate relevant safety and efficacy data, and to characterize the factors driving melatonin administration by parents.
“Studies like these add to our knowledge base and give us insight into what patients or parents may be doing that can impact overall health,” said Alfonso J. Padilla, MD, assistant clinical professor of sleep medicine at the University of California, Los Angeles, in a written comment. “Often, in normal encounters with our patients we may not be able to gather this information easily. It may help open conversations about sleep issues that are not being addressed.”
Dr. Padilla suggested that parents may believe that melatonin is safe because it is not regulated by the Food and Drug Administration, when in fact they could be negatively impacting their children’s sleep. He noted that short-term risks include altered circadian rhythm and vivid dreams or nightmares, while long-term safety remains unclear.
“As a sleep physician, I use melatonin for specific indications only,” Dr. Padilla said. “I may use it in small children that are having difficulty falling asleep, especially in children with autism or special needs. I also use it for help in adjustment in circadian rhythm, especially in adolescents.”
He recommends melatonin, he added, if he has a complete case history, and melatonin is suitable for that patient.
Typically, it’s not.
“Most often a medication is not the answer for the sleep concern that parents are having about their child,” he said.
The investigators disclosed grants from the Eunice Kennedy Shriver National Institute of Child Health and Human Development and the Colorado Clinical and Translational Science Award Program of the National Center for Advancing Translational Sciences of the National Institutes of Health. They reported no conflicts of interest.
FROM JAMA PEDIATRICS
Long-term use of ADHD meds and CVD risk: New data
results of a large Swedish nested case-control study suggest.
The increased risk was evident only for hypertension and arterial disease, was dose dependent, and was higher for stimulant than nonstimulant ADHD medications.
“Clinicians should be vigilant in monitoring signs and symptoms of cardiovascular diseases, particularly among those receiving higher doses,” Zheng Chang, PhD, principal researcher, department of medical epidemiology and biostatistics, Karolinska Institutet, Stockholm, said in an interview.
“Treatment decisions, as always, should be based on careful weighing of potential benefits and risks at individual patient level, rather than simple one-size-fits-all recommendations,” Dr. Chang added.
The study was published online in JAMA Psychiatry
Filling in the research gaps
The use of medications to treat ADHD has increased markedly over the past decades in both children and adults. The potential risk for CVD associated with long-term ADHD medication use remains unclear. Most “longitudinal” studies that have looked at the association have an average follow-up time of no more than 2 years, the authors note.
In contrast, the Swedish study assessed the association between cumulative use of ADHD medication in children and adults followed for up to 14 years and also looked at whether associations differ across types of medication and dosages, types of CVD, gender, and age.
Among 278,027 individuals aged 6-64 years diagnosed with ADHD or dispensed ADHD medication, 10,388 with CVD were identified and matched to 51,672 controls without CVD.
Longer cumulative duration of ADHD medication use was associated with a statistically significant increased risk for CVD, compared with no use.
When the risk for specific CVDs was examined, long-term use of ADHD medication (compared with no use) was associated with an increased risk for hypertension and arterial disease but not arrhythmias, heart failure, ischemic heart disease, thromboembolic disease, or cerebrovascular disease.
For hypertension, the adjusted odds ratio was 1.72 (95% confidence interval, 1.51-1.97) for 3 to ≤ 5 years and 1.80 (95% CI, 1.55-2.08) for > 5 years of medication use. For arterial disease, the AOR was 1.65 (95% CI, 1.11-2.45) for 3 to ≤ 5 years and 1.49 (95% CI, 0.96-2.32) for > 5 years of use.
Stimulants confer greatest risk
Across the 14-year follow-up period, each additional year of ADHD medication use was associated with an average 4% increased CVD risk, with a larger 8% increased risk in the first 3 years of cumulative use, followed by stable risk over the remaining follow-up.
Similar risks were observed in children and adults, as well as in females and males.
When focusing on specific ADHD medications, compared with no use, long-term use of the stimulant methylphenidate was associated with an increased risk for CVD (AOR, 1.20 [95% CI, 1.10-1.31] for 3 to ≤ 5 years and 1.19 [95% CI, 1.08-1.31] for > 5 years).
The same was true for long-term use of the stimulant lisdexamfetamine (AOR, 1.23 [95% CI, 1.05-1.44] for 2 to ≤ 3 years and 1.17 [95% CI, 0.98-1.40] for > 3 years).
In contrast, use of the nonstimulant atomoxetine was associated with elevated CVD risk only for the first year of use (AOR, 1.07; 95% CI, 1.01-1.13).
The increased risk for CVD occurred only above certain average daily doses: 45 mg for methylphenidate and lisdexamfetamine, 22.5 mg for amphetamines, and 120 mg for atomoxetine.
The authors note that, although they accounted for a wide range of potential confounding variables, considering the observational nature of the study and the possibility of residual confounding, they could not prove causality.
‘Tricky trade-offs’
The coauthors of an editorial in JAMA Psychiatry (2023 Nov 22. doi: 10.1001/jamapsychiatry.2023.4126) note that the study “should remind us that clinical decision-making is often based on tricky trade-offs that should be considered at the individual patient level.”
Given that hypertension is the leading cause of CV morbidity and mortality worldwide, the increased likelihood of hypertension with long-term use of ADHD medications “cannot be disregarded,” write Samuele Cortese, MD, PhD, and Cristiano Fava, MD, PhD, with University of Southampton (England).
“These findings are especially relevant given the reported association between ADHD and physical conditions, such as obesity, which further contribute to increased cardiovascular risk,” they add.
Dr. Cortese and Dr. Fava say that the increased CV risk – averaging 4% per year and stabilizing after 3 years of treatment – “should be carefully weighed against the established benefits, on a case-by-case basis.”
“Importantly,” they write, “large real-world self-controlled studies have shown that individuals with ADHD experience significantly fewer unintentional physical injuries, motor vehicle crashes, substance use disorders, and criminal acts, as well as improved academic functioning, during periods when they are taking, compared with periods when they are not taking, methylphenidate.”
The risk-benefit ratio, however, may be lower in people with preexisting heart conditions. However, more evidence and precise recommendations are needed in relation to the treatment of individuals with ADHD and preexisting CV conditions, the editorial writers say.
This study was supported by grants from the Swedish Research Council for Health, Working Life, and Welfare and the European Union’s Horizon 2020 research and innovation program. The authors and editorial writers have no relevant conflicts of interest.
A version of this article appeared on Medscape.com.
results of a large Swedish nested case-control study suggest.
The increased risk was evident only for hypertension and arterial disease, was dose dependent, and was higher for stimulant than nonstimulant ADHD medications.
“Clinicians should be vigilant in monitoring signs and symptoms of cardiovascular diseases, particularly among those receiving higher doses,” Zheng Chang, PhD, principal researcher, department of medical epidemiology and biostatistics, Karolinska Institutet, Stockholm, said in an interview.
“Treatment decisions, as always, should be based on careful weighing of potential benefits and risks at individual patient level, rather than simple one-size-fits-all recommendations,” Dr. Chang added.
The study was published online in JAMA Psychiatry
Filling in the research gaps
The use of medications to treat ADHD has increased markedly over the past decades in both children and adults. The potential risk for CVD associated with long-term ADHD medication use remains unclear. Most “longitudinal” studies that have looked at the association have an average follow-up time of no more than 2 years, the authors note.
In contrast, the Swedish study assessed the association between cumulative use of ADHD medication in children and adults followed for up to 14 years and also looked at whether associations differ across types of medication and dosages, types of CVD, gender, and age.
Among 278,027 individuals aged 6-64 years diagnosed with ADHD or dispensed ADHD medication, 10,388 with CVD were identified and matched to 51,672 controls without CVD.
Longer cumulative duration of ADHD medication use was associated with a statistically significant increased risk for CVD, compared with no use.
When the risk for specific CVDs was examined, long-term use of ADHD medication (compared with no use) was associated with an increased risk for hypertension and arterial disease but not arrhythmias, heart failure, ischemic heart disease, thromboembolic disease, or cerebrovascular disease.
For hypertension, the adjusted odds ratio was 1.72 (95% confidence interval, 1.51-1.97) for 3 to ≤ 5 years and 1.80 (95% CI, 1.55-2.08) for > 5 years of medication use. For arterial disease, the AOR was 1.65 (95% CI, 1.11-2.45) for 3 to ≤ 5 years and 1.49 (95% CI, 0.96-2.32) for > 5 years of use.
Stimulants confer greatest risk
Across the 14-year follow-up period, each additional year of ADHD medication use was associated with an average 4% increased CVD risk, with a larger 8% increased risk in the first 3 years of cumulative use, followed by stable risk over the remaining follow-up.
Similar risks were observed in children and adults, as well as in females and males.
When focusing on specific ADHD medications, compared with no use, long-term use of the stimulant methylphenidate was associated with an increased risk for CVD (AOR, 1.20 [95% CI, 1.10-1.31] for 3 to ≤ 5 years and 1.19 [95% CI, 1.08-1.31] for > 5 years).
The same was true for long-term use of the stimulant lisdexamfetamine (AOR, 1.23 [95% CI, 1.05-1.44] for 2 to ≤ 3 years and 1.17 [95% CI, 0.98-1.40] for > 3 years).
In contrast, use of the nonstimulant atomoxetine was associated with elevated CVD risk only for the first year of use (AOR, 1.07; 95% CI, 1.01-1.13).
The increased risk for CVD occurred only above certain average daily doses: 45 mg for methylphenidate and lisdexamfetamine, 22.5 mg for amphetamines, and 120 mg for atomoxetine.
The authors note that, although they accounted for a wide range of potential confounding variables, considering the observational nature of the study and the possibility of residual confounding, they could not prove causality.
‘Tricky trade-offs’
The coauthors of an editorial in JAMA Psychiatry (2023 Nov 22. doi: 10.1001/jamapsychiatry.2023.4126) note that the study “should remind us that clinical decision-making is often based on tricky trade-offs that should be considered at the individual patient level.”
Given that hypertension is the leading cause of CV morbidity and mortality worldwide, the increased likelihood of hypertension with long-term use of ADHD medications “cannot be disregarded,” write Samuele Cortese, MD, PhD, and Cristiano Fava, MD, PhD, with University of Southampton (England).
“These findings are especially relevant given the reported association between ADHD and physical conditions, such as obesity, which further contribute to increased cardiovascular risk,” they add.
Dr. Cortese and Dr. Fava say that the increased CV risk – averaging 4% per year and stabilizing after 3 years of treatment – “should be carefully weighed against the established benefits, on a case-by-case basis.”
“Importantly,” they write, “large real-world self-controlled studies have shown that individuals with ADHD experience significantly fewer unintentional physical injuries, motor vehicle crashes, substance use disorders, and criminal acts, as well as improved academic functioning, during periods when they are taking, compared with periods when they are not taking, methylphenidate.”
The risk-benefit ratio, however, may be lower in people with preexisting heart conditions. However, more evidence and precise recommendations are needed in relation to the treatment of individuals with ADHD and preexisting CV conditions, the editorial writers say.
This study was supported by grants from the Swedish Research Council for Health, Working Life, and Welfare and the European Union’s Horizon 2020 research and innovation program. The authors and editorial writers have no relevant conflicts of interest.
A version of this article appeared on Medscape.com.
results of a large Swedish nested case-control study suggest.
The increased risk was evident only for hypertension and arterial disease, was dose dependent, and was higher for stimulant than nonstimulant ADHD medications.
“Clinicians should be vigilant in monitoring signs and symptoms of cardiovascular diseases, particularly among those receiving higher doses,” Zheng Chang, PhD, principal researcher, department of medical epidemiology and biostatistics, Karolinska Institutet, Stockholm, said in an interview.
“Treatment decisions, as always, should be based on careful weighing of potential benefits and risks at individual patient level, rather than simple one-size-fits-all recommendations,” Dr. Chang added.
The study was published online in JAMA Psychiatry
Filling in the research gaps
The use of medications to treat ADHD has increased markedly over the past decades in both children and adults. The potential risk for CVD associated with long-term ADHD medication use remains unclear. Most “longitudinal” studies that have looked at the association have an average follow-up time of no more than 2 years, the authors note.
In contrast, the Swedish study assessed the association between cumulative use of ADHD medication in children and adults followed for up to 14 years and also looked at whether associations differ across types of medication and dosages, types of CVD, gender, and age.
Among 278,027 individuals aged 6-64 years diagnosed with ADHD or dispensed ADHD medication, 10,388 with CVD were identified and matched to 51,672 controls without CVD.
Longer cumulative duration of ADHD medication use was associated with a statistically significant increased risk for CVD, compared with no use.
When the risk for specific CVDs was examined, long-term use of ADHD medication (compared with no use) was associated with an increased risk for hypertension and arterial disease but not arrhythmias, heart failure, ischemic heart disease, thromboembolic disease, or cerebrovascular disease.
For hypertension, the adjusted odds ratio was 1.72 (95% confidence interval, 1.51-1.97) for 3 to ≤ 5 years and 1.80 (95% CI, 1.55-2.08) for > 5 years of medication use. For arterial disease, the AOR was 1.65 (95% CI, 1.11-2.45) for 3 to ≤ 5 years and 1.49 (95% CI, 0.96-2.32) for > 5 years of use.
Stimulants confer greatest risk
Across the 14-year follow-up period, each additional year of ADHD medication use was associated with an average 4% increased CVD risk, with a larger 8% increased risk in the first 3 years of cumulative use, followed by stable risk over the remaining follow-up.
Similar risks were observed in children and adults, as well as in females and males.
When focusing on specific ADHD medications, compared with no use, long-term use of the stimulant methylphenidate was associated with an increased risk for CVD (AOR, 1.20 [95% CI, 1.10-1.31] for 3 to ≤ 5 years and 1.19 [95% CI, 1.08-1.31] for > 5 years).
The same was true for long-term use of the stimulant lisdexamfetamine (AOR, 1.23 [95% CI, 1.05-1.44] for 2 to ≤ 3 years and 1.17 [95% CI, 0.98-1.40] for > 3 years).
In contrast, use of the nonstimulant atomoxetine was associated with elevated CVD risk only for the first year of use (AOR, 1.07; 95% CI, 1.01-1.13).
The increased risk for CVD occurred only above certain average daily doses: 45 mg for methylphenidate and lisdexamfetamine, 22.5 mg for amphetamines, and 120 mg for atomoxetine.
The authors note that, although they accounted for a wide range of potential confounding variables, considering the observational nature of the study and the possibility of residual confounding, they could not prove causality.
‘Tricky trade-offs’
The coauthors of an editorial in JAMA Psychiatry (2023 Nov 22. doi: 10.1001/jamapsychiatry.2023.4126) note that the study “should remind us that clinical decision-making is often based on tricky trade-offs that should be considered at the individual patient level.”
Given that hypertension is the leading cause of CV morbidity and mortality worldwide, the increased likelihood of hypertension with long-term use of ADHD medications “cannot be disregarded,” write Samuele Cortese, MD, PhD, and Cristiano Fava, MD, PhD, with University of Southampton (England).
“These findings are especially relevant given the reported association between ADHD and physical conditions, such as obesity, which further contribute to increased cardiovascular risk,” they add.
Dr. Cortese and Dr. Fava say that the increased CV risk – averaging 4% per year and stabilizing after 3 years of treatment – “should be carefully weighed against the established benefits, on a case-by-case basis.”
“Importantly,” they write, “large real-world self-controlled studies have shown that individuals with ADHD experience significantly fewer unintentional physical injuries, motor vehicle crashes, substance use disorders, and criminal acts, as well as improved academic functioning, during periods when they are taking, compared with periods when they are not taking, methylphenidate.”
The risk-benefit ratio, however, may be lower in people with preexisting heart conditions. However, more evidence and precise recommendations are needed in relation to the treatment of individuals with ADHD and preexisting CV conditions, the editorial writers say.
This study was supported by grants from the Swedish Research Council for Health, Working Life, and Welfare and the European Union’s Horizon 2020 research and innovation program. The authors and editorial writers have no relevant conflicts of interest.
A version of this article appeared on Medscape.com.
FROM JAMA PSYCHIATRY
Tapinarof effective for AD in patients as young as 2 years
BERLIN – of age, according to results of two pivotal trials presented at the at the annual congress of the European Academy of Dermatology and Venereology.
If approved for AD, one advantage of tapinarof cream relative to topical corticosteroids is potential use “without restrictions on duration, extent, or site of application,” reported Jonathan I. Silverberg, MD, PhD, MPH, director of clinical research, George Washington University, Washington.
Tapinarof cream, 1%, an aryl hydrocarbon receptor agonist, was approved in 2022 for treating plaque psoriasis in adults.
In the two phase 3 trials, ADORING 1 and ADORING 2, which were presented together at the meeting, the primary endpoint was Validated Investigator Global Assessment (vIGA) for AD of 0 (clear) or 1 (almost clear) at 8 weeks. For this endpoint and all secondary endpoints, the relative advantage of the active cream over the vehicle alone was about the same in both studies.
For example, the vIGA clear or almost clear response was met by 45.4% and 46.4% of those in the experimental arm of ADORING 1 and 2, respectively, but only 13.9% and 18.0% in the control arms (P < .0001 for both).
For the secondary endpoint of Eczema Area and Severity Index (EASI75), signifying 75% clearance of skin lesions, the response rates were 55.8% and 59.1% in the two trials, but only 22.9% and 24.1% in the respective control arms (P < .0001 for both).
The two identically designed trials randomized patients with moderate to severe AD in a 2:1 ratio to tapinarof cream or vehicle alone. There were 407 patients ages 2-81 years in ADORING I and 406 in ADORING 2. Patients were instructed to apply the active cream or vehicle once per day.
The safety data for tapinarof in these studies was generally consistent with the experience with this agent in plaque psoriasis. According to Dr. Silverberg, there was a modest increase in reports of headache early in this study, but these were transient. Follicular events were also more common on tapinarof than on its vehicle, but Dr. Silverberg said that the rate of discontinuations for adverse events, although low in both arms, was numerically lower in the active treatment arm in both trials.
“There were reports of contact dermatitis in the psoriasis studies, but we have not seen this in the AD trials,” Dr. Silverberg said.
Itch control evaluated
In a separate presentation of ADORING 1 and 2 results, Eric Simpson, MD, professor of dermatology, Oregon Health & Science University, Portland, provided detailed information about itch control, which was evaluated with the Peak Pruritus–Numerical Rating Scale (PP-NRS).
“The PP-NRS considers a person’s worst itch over the past 24 hours based on an 11-point scale,” explained Dr. Simpson, who said that patients scored itch daily with comparisons made at weeks 1, 2, 4, and 8.
Over time, pruritus scores fell in both groups, but reductions were far steeper among those in the active treatment arms.
“In ADORING 1, there were greater reductions in itch as early as day 1,” Dr. Simpson reported. Although the differences in itch were not detected until day 2 in ADORING 2, the differences were already significant and clinically meaningful in both studies by the end of the first week.
By week 8, the mean reductions in PP-NRS scores were 2.6 and 2.4 in the vehicle arms of ADORING 1 and 2, respectively. In the treatment arm, the reduction was 4.1 points in both arms (P < .0001 for both studies).
Forty-eight–week follow-up planned
More than 90% of patients in both studies have rolled over into the open-label extension ADORING 3 trial, with a planned follow-up of 48 weeks, according to Dr. Silverberg, who said that those in the placebo arm have been crossed over to tapinarof.
The response and the safety appear to be similar in adults and children, although Dr. Silverberg said that further analyses of outcomes by age are planned. He noted that there is also an ongoing study of tapinarof in children with plaque psoriasis.
In AD in particular, Dr. Silverberg said there is “an unmet need” for a topical nonsteroidal anti-inflammatory. While topical corticosteroids are a mainstay of AD therapy in children as well as adults, he noted the limitations of these drugs, including that they can only be applied for limited periods.
Tapinarof binds to the aryl hydrocarbon receptor (AhR), which regulates immune function in the skin and is expressed in many skin cell types. By inhibiting AhR, tapinarof blocks cytokine activation and has an antioxidant effect.
Adelaide A. Hebert, MD, professor and director of pediatric dermatology, McGovern Medical School at UTHealth, Houston, has participated in clinical studies of tapinarof for AD, and said she has been impressed with its efficacy and tolerability in children as well as adults. In the case of children, parents, as well as patients, “valued the rapid onset of disease control, the once-daily application regimen, and the itch control,” she said in an interview after the meeting.
If approved, Dr. Hebert said, “this novel steroid-free medication has the potential to change the management arena for pediatric and adult patients with moderate to severe atopic dermatitis.”
The recent introduction of new systemic therapies for AD, such as JAK inhibitors, has increased options for AD control, but “we still need effective and safe topical therapies, especially in children and young adults,” said Sonja Ständer, MD, head of the Interdisciplinary Center for Chronic Pruritus, University of Münster (Germany). Author of a comprehensive review article on AD in the New England Journal of Medicine 2 years ago, Dr. Ständer said results from the phase 3 topical tapinarof trials, as well as the phase 3 topical ruxolitinib trials, which were also presented as late breakers at the 2023 EADV meeting, provide “hope that an alternative to topical steroids will soon be available.”
Based on their safety and rapid control of itch in children with AD, “these will complement our current portfolio of topical therapies very well and have the potential to replace topical steroids early in therapy or to replace them altogether,” she told this news organization.
Dermavant Sciences, manufacturer of tapinarof, anticipates filing for Food and Drug Administration approval for AD in the first quarter of 2024, according to a company statement.
Dr. Silverberg and Dr. Simpson reported financial relationships with multiple pharmaceutical companies, including Dermavant, which provided funding for the ADORING trials. Dr. Hebert has financial relationship with more than 15 pharmaceutical companies, including Dermavent and other companies that have or are developing therapies for AD. Dr. Ständer reported financial relationships with Beiersdorf, Eli Lilly, Galderma, Kiniksa, Pfizer, and Sanofi.
BERLIN – of age, according to results of two pivotal trials presented at the at the annual congress of the European Academy of Dermatology and Venereology.
If approved for AD, one advantage of tapinarof cream relative to topical corticosteroids is potential use “without restrictions on duration, extent, or site of application,” reported Jonathan I. Silverberg, MD, PhD, MPH, director of clinical research, George Washington University, Washington.
Tapinarof cream, 1%, an aryl hydrocarbon receptor agonist, was approved in 2022 for treating plaque psoriasis in adults.
In the two phase 3 trials, ADORING 1 and ADORING 2, which were presented together at the meeting, the primary endpoint was Validated Investigator Global Assessment (vIGA) for AD of 0 (clear) or 1 (almost clear) at 8 weeks. For this endpoint and all secondary endpoints, the relative advantage of the active cream over the vehicle alone was about the same in both studies.
For example, the vIGA clear or almost clear response was met by 45.4% and 46.4% of those in the experimental arm of ADORING 1 and 2, respectively, but only 13.9% and 18.0% in the control arms (P < .0001 for both).
For the secondary endpoint of Eczema Area and Severity Index (EASI75), signifying 75% clearance of skin lesions, the response rates were 55.8% and 59.1% in the two trials, but only 22.9% and 24.1% in the respective control arms (P < .0001 for both).
The two identically designed trials randomized patients with moderate to severe AD in a 2:1 ratio to tapinarof cream or vehicle alone. There were 407 patients ages 2-81 years in ADORING I and 406 in ADORING 2. Patients were instructed to apply the active cream or vehicle once per day.
The safety data for tapinarof in these studies was generally consistent with the experience with this agent in plaque psoriasis. According to Dr. Silverberg, there was a modest increase in reports of headache early in this study, but these were transient. Follicular events were also more common on tapinarof than on its vehicle, but Dr. Silverberg said that the rate of discontinuations for adverse events, although low in both arms, was numerically lower in the active treatment arm in both trials.
“There were reports of contact dermatitis in the psoriasis studies, but we have not seen this in the AD trials,” Dr. Silverberg said.
Itch control evaluated
In a separate presentation of ADORING 1 and 2 results, Eric Simpson, MD, professor of dermatology, Oregon Health & Science University, Portland, provided detailed information about itch control, which was evaluated with the Peak Pruritus–Numerical Rating Scale (PP-NRS).
“The PP-NRS considers a person’s worst itch over the past 24 hours based on an 11-point scale,” explained Dr. Simpson, who said that patients scored itch daily with comparisons made at weeks 1, 2, 4, and 8.
Over time, pruritus scores fell in both groups, but reductions were far steeper among those in the active treatment arms.
“In ADORING 1, there were greater reductions in itch as early as day 1,” Dr. Simpson reported. Although the differences in itch were not detected until day 2 in ADORING 2, the differences were already significant and clinically meaningful in both studies by the end of the first week.
By week 8, the mean reductions in PP-NRS scores were 2.6 and 2.4 in the vehicle arms of ADORING 1 and 2, respectively. In the treatment arm, the reduction was 4.1 points in both arms (P < .0001 for both studies).
Forty-eight–week follow-up planned
More than 90% of patients in both studies have rolled over into the open-label extension ADORING 3 trial, with a planned follow-up of 48 weeks, according to Dr. Silverberg, who said that those in the placebo arm have been crossed over to tapinarof.
The response and the safety appear to be similar in adults and children, although Dr. Silverberg said that further analyses of outcomes by age are planned. He noted that there is also an ongoing study of tapinarof in children with plaque psoriasis.
In AD in particular, Dr. Silverberg said there is “an unmet need” for a topical nonsteroidal anti-inflammatory. While topical corticosteroids are a mainstay of AD therapy in children as well as adults, he noted the limitations of these drugs, including that they can only be applied for limited periods.
Tapinarof binds to the aryl hydrocarbon receptor (AhR), which regulates immune function in the skin and is expressed in many skin cell types. By inhibiting AhR, tapinarof blocks cytokine activation and has an antioxidant effect.
Adelaide A. Hebert, MD, professor and director of pediatric dermatology, McGovern Medical School at UTHealth, Houston, has participated in clinical studies of tapinarof for AD, and said she has been impressed with its efficacy and tolerability in children as well as adults. In the case of children, parents, as well as patients, “valued the rapid onset of disease control, the once-daily application regimen, and the itch control,” she said in an interview after the meeting.
If approved, Dr. Hebert said, “this novel steroid-free medication has the potential to change the management arena for pediatric and adult patients with moderate to severe atopic dermatitis.”
The recent introduction of new systemic therapies for AD, such as JAK inhibitors, has increased options for AD control, but “we still need effective and safe topical therapies, especially in children and young adults,” said Sonja Ständer, MD, head of the Interdisciplinary Center for Chronic Pruritus, University of Münster (Germany). Author of a comprehensive review article on AD in the New England Journal of Medicine 2 years ago, Dr. Ständer said results from the phase 3 topical tapinarof trials, as well as the phase 3 topical ruxolitinib trials, which were also presented as late breakers at the 2023 EADV meeting, provide “hope that an alternative to topical steroids will soon be available.”
Based on their safety and rapid control of itch in children with AD, “these will complement our current portfolio of topical therapies very well and have the potential to replace topical steroids early in therapy or to replace them altogether,” she told this news organization.
Dermavant Sciences, manufacturer of tapinarof, anticipates filing for Food and Drug Administration approval for AD in the first quarter of 2024, according to a company statement.
Dr. Silverberg and Dr. Simpson reported financial relationships with multiple pharmaceutical companies, including Dermavant, which provided funding for the ADORING trials. Dr. Hebert has financial relationship with more than 15 pharmaceutical companies, including Dermavent and other companies that have or are developing therapies for AD. Dr. Ständer reported financial relationships with Beiersdorf, Eli Lilly, Galderma, Kiniksa, Pfizer, and Sanofi.
BERLIN – of age, according to results of two pivotal trials presented at the at the annual congress of the European Academy of Dermatology and Venereology.
If approved for AD, one advantage of tapinarof cream relative to topical corticosteroids is potential use “without restrictions on duration, extent, or site of application,” reported Jonathan I. Silverberg, MD, PhD, MPH, director of clinical research, George Washington University, Washington.
Tapinarof cream, 1%, an aryl hydrocarbon receptor agonist, was approved in 2022 for treating plaque psoriasis in adults.
In the two phase 3 trials, ADORING 1 and ADORING 2, which were presented together at the meeting, the primary endpoint was Validated Investigator Global Assessment (vIGA) for AD of 0 (clear) or 1 (almost clear) at 8 weeks. For this endpoint and all secondary endpoints, the relative advantage of the active cream over the vehicle alone was about the same in both studies.
For example, the vIGA clear or almost clear response was met by 45.4% and 46.4% of those in the experimental arm of ADORING 1 and 2, respectively, but only 13.9% and 18.0% in the control arms (P < .0001 for both).
For the secondary endpoint of Eczema Area and Severity Index (EASI75), signifying 75% clearance of skin lesions, the response rates were 55.8% and 59.1% in the two trials, but only 22.9% and 24.1% in the respective control arms (P < .0001 for both).
The two identically designed trials randomized patients with moderate to severe AD in a 2:1 ratio to tapinarof cream or vehicle alone. There were 407 patients ages 2-81 years in ADORING I and 406 in ADORING 2. Patients were instructed to apply the active cream or vehicle once per day.
The safety data for tapinarof in these studies was generally consistent with the experience with this agent in plaque psoriasis. According to Dr. Silverberg, there was a modest increase in reports of headache early in this study, but these were transient. Follicular events were also more common on tapinarof than on its vehicle, but Dr. Silverberg said that the rate of discontinuations for adverse events, although low in both arms, was numerically lower in the active treatment arm in both trials.
“There were reports of contact dermatitis in the psoriasis studies, but we have not seen this in the AD trials,” Dr. Silverberg said.
Itch control evaluated
In a separate presentation of ADORING 1 and 2 results, Eric Simpson, MD, professor of dermatology, Oregon Health & Science University, Portland, provided detailed information about itch control, which was evaluated with the Peak Pruritus–Numerical Rating Scale (PP-NRS).
“The PP-NRS considers a person’s worst itch over the past 24 hours based on an 11-point scale,” explained Dr. Simpson, who said that patients scored itch daily with comparisons made at weeks 1, 2, 4, and 8.
Over time, pruritus scores fell in both groups, but reductions were far steeper among those in the active treatment arms.
“In ADORING 1, there were greater reductions in itch as early as day 1,” Dr. Simpson reported. Although the differences in itch were not detected until day 2 in ADORING 2, the differences were already significant and clinically meaningful in both studies by the end of the first week.
By week 8, the mean reductions in PP-NRS scores were 2.6 and 2.4 in the vehicle arms of ADORING 1 and 2, respectively. In the treatment arm, the reduction was 4.1 points in both arms (P < .0001 for both studies).
Forty-eight–week follow-up planned
More than 90% of patients in both studies have rolled over into the open-label extension ADORING 3 trial, with a planned follow-up of 48 weeks, according to Dr. Silverberg, who said that those in the placebo arm have been crossed over to tapinarof.
The response and the safety appear to be similar in adults and children, although Dr. Silverberg said that further analyses of outcomes by age are planned. He noted that there is also an ongoing study of tapinarof in children with plaque psoriasis.
In AD in particular, Dr. Silverberg said there is “an unmet need” for a topical nonsteroidal anti-inflammatory. While topical corticosteroids are a mainstay of AD therapy in children as well as adults, he noted the limitations of these drugs, including that they can only be applied for limited periods.
Tapinarof binds to the aryl hydrocarbon receptor (AhR), which regulates immune function in the skin and is expressed in many skin cell types. By inhibiting AhR, tapinarof blocks cytokine activation and has an antioxidant effect.
Adelaide A. Hebert, MD, professor and director of pediatric dermatology, McGovern Medical School at UTHealth, Houston, has participated in clinical studies of tapinarof for AD, and said she has been impressed with its efficacy and tolerability in children as well as adults. In the case of children, parents, as well as patients, “valued the rapid onset of disease control, the once-daily application regimen, and the itch control,” she said in an interview after the meeting.
If approved, Dr. Hebert said, “this novel steroid-free medication has the potential to change the management arena for pediatric and adult patients with moderate to severe atopic dermatitis.”
The recent introduction of new systemic therapies for AD, such as JAK inhibitors, has increased options for AD control, but “we still need effective and safe topical therapies, especially in children and young adults,” said Sonja Ständer, MD, head of the Interdisciplinary Center for Chronic Pruritus, University of Münster (Germany). Author of a comprehensive review article on AD in the New England Journal of Medicine 2 years ago, Dr. Ständer said results from the phase 3 topical tapinarof trials, as well as the phase 3 topical ruxolitinib trials, which were also presented as late breakers at the 2023 EADV meeting, provide “hope that an alternative to topical steroids will soon be available.”
Based on their safety and rapid control of itch in children with AD, “these will complement our current portfolio of topical therapies very well and have the potential to replace topical steroids early in therapy or to replace them altogether,” she told this news organization.
Dermavant Sciences, manufacturer of tapinarof, anticipates filing for Food and Drug Administration approval for AD in the first quarter of 2024, according to a company statement.
Dr. Silverberg and Dr. Simpson reported financial relationships with multiple pharmaceutical companies, including Dermavant, which provided funding for the ADORING trials. Dr. Hebert has financial relationship with more than 15 pharmaceutical companies, including Dermavent and other companies that have or are developing therapies for AD. Dr. Ständer reported financial relationships with Beiersdorf, Eli Lilly, Galderma, Kiniksa, Pfizer, and Sanofi.
AT THE EADV CONGRESS
Quitting tobacco can improve lung health in COPD
Reducing exposure to tobacco smoke may reduce the burden of chronic obstructive pulmonary disease, and public health measures are needed, according to a new Tobacco Knowledge Summary from the World Health Organization.
“Smoking is a major risk factor for COPD and leads to airway inflammation and remodeling associated with lung destruction,” and contributes to approximately 70% of COPD cases worldwide, according to the statement.
Types of tobacco exposure include not only traditional smoked tobacco products (cigarettes, cigars, pipes, water pipes, kreteks, and bidis), but also smokeless tobacco, heated tobacco products, and electronic nicotine delivery systems; the addition of chemicals and flavors can increase the appeal of tobacco products and promote addiction, the authors wrote. Hookahs and water pipes “are at least as detrimental to lung health as smoking cigarettes and should not be considered as a safe alternative,” they added.
The risk of COPD extends to new e-cigarette products, the authors noted. A study in the American Journal of Preventive Medicine showed that current users of e-cigarettes had a 75% increased risk of developing COPD compared with individuals who have never used e-cigarettes.
Individuals with COPD also face an increased risk of cardiovascular disease and type 2 diabetes, and smokers with COPD who quit not only improve their COPD but also reduce their risk of developing these conditions, the authors said.
Mechanism of action explored
The authors noted how tobacco smoking may cause COPD when inhaled particles are deposited through the airway.
Growing evidence suggests that extracellular vesicles may play a role in the development of lung disorders such as COPD, and cigarette smoke can have an impact through this channel. A study published in the American Journal of Respiratory and Critical Care Medicine offered evidence of a potential link between exposure to cigarette smoke and the generation of a unique extracellular vesicle population that could promote the development of lung damage. In the study, Matthew C. Madison, MD, of the University of Alabama, Birmingham, and colleagues examined activity in extracellular vesicles from the bronchoalveolar lavage (BAL) fluid of smoke-exposed mice and human smokers who were otherwise healthy.
The researchers found that airway extracellular vesicles in mice or humans exposed to cigarette smoke had the ability to cause rapid lung damage when transferred into naive recipient mice. The results provide a new model that can inform preclinical COPD research, they wrote.
Public health action needed
“In recognition of COPD and Lung Cancer Awareness Month, the World Health Organization (WHO) emphasizes the impact of various forms of tobacco use on COPD,” Dharani K. Narendra, MD, of Baylor College of Medicine, Houston, said in an interview.
“This article focuses on the different types of tobacco exposure, the health care burden associated with COPD, and the risk of developing lung cancer. It also addresses the high-risk groups, especially youth, underscoring the importance of public education and the implementation of restrictions on tobacco use to combat these growing concerns,” she said.
“Education, awareness, and targeted interventions are essential for smoking cessation and COPD management,” said Dr. Narendra. “These elements are key to informing the public about smoking risks, encouraging behavioral change, and ultimately reducing the incidence of smoking-related diseases,” she emphasized.
The WHO statement called for population-level interventions including brief advice to tobacco users, toll-free quit lines, pharmacological interventions, use of messaging and chatbots to provide quit support, and the WHO quit tobacco mobile app.
“It is imperative that all tobacco users, particularly those living in low- to middle-income countries, have access to comprehensive cessation support aligned with WHO recommendations,” the authors wrote.
Finally, the authors emphasized the need to protect children and teens from the dangers of tobacco use through product regulation and to expose the tobacco industry’s marketing tactics.
“The article offers a comprehensive look at different types of tobacco exposure and their contribution to the development of COPD,” Dr. Narendra told this news organization. “Notably, it presents groundbreaking evidence of a strong association between the use of electronic nicotine delivery systems (ENDS) and heated tobacco products to development of COPD; additionally, it provides valuable guidance on smoking cessation resources for physicians to help patients quit smoking,” she said.
Looking ahead, more research is needed on “developing and sustaining state-specific or population-specific interventions for effective smoking cessation programs, and reducing the burden of COPD,” Dr. Narendra said.
The study by Madison and colleagues was supported by the National Heart, Lung, and Blood Institute, the National Institute of General Medical Science, the U.S. Veterans Affairs Administration, the Cystic Fibrosis Foundation Research Development Program, and the Veterans Affairs Merit grant.
Additional financial support came from Imperial College London, a Wellcome Trust Senior Research Fellowship, and Rosetrees Trust/The Stoneygate Trust.
Dr. Narendra had no financial conflicts to disclose but serves as a member of the editorial board of CHEST Physician.
Reducing exposure to tobacco smoke may reduce the burden of chronic obstructive pulmonary disease, and public health measures are needed, according to a new Tobacco Knowledge Summary from the World Health Organization.
“Smoking is a major risk factor for COPD and leads to airway inflammation and remodeling associated with lung destruction,” and contributes to approximately 70% of COPD cases worldwide, according to the statement.
Types of tobacco exposure include not only traditional smoked tobacco products (cigarettes, cigars, pipes, water pipes, kreteks, and bidis), but also smokeless tobacco, heated tobacco products, and electronic nicotine delivery systems; the addition of chemicals and flavors can increase the appeal of tobacco products and promote addiction, the authors wrote. Hookahs and water pipes “are at least as detrimental to lung health as smoking cigarettes and should not be considered as a safe alternative,” they added.
The risk of COPD extends to new e-cigarette products, the authors noted. A study in the American Journal of Preventive Medicine showed that current users of e-cigarettes had a 75% increased risk of developing COPD compared with individuals who have never used e-cigarettes.
Individuals with COPD also face an increased risk of cardiovascular disease and type 2 diabetes, and smokers with COPD who quit not only improve their COPD but also reduce their risk of developing these conditions, the authors said.
Mechanism of action explored
The authors noted how tobacco smoking may cause COPD when inhaled particles are deposited through the airway.
Growing evidence suggests that extracellular vesicles may play a role in the development of lung disorders such as COPD, and cigarette smoke can have an impact through this channel. A study published in the American Journal of Respiratory and Critical Care Medicine offered evidence of a potential link between exposure to cigarette smoke and the generation of a unique extracellular vesicle population that could promote the development of lung damage. In the study, Matthew C. Madison, MD, of the University of Alabama, Birmingham, and colleagues examined activity in extracellular vesicles from the bronchoalveolar lavage (BAL) fluid of smoke-exposed mice and human smokers who were otherwise healthy.
The researchers found that airway extracellular vesicles in mice or humans exposed to cigarette smoke had the ability to cause rapid lung damage when transferred into naive recipient mice. The results provide a new model that can inform preclinical COPD research, they wrote.
Public health action needed
“In recognition of COPD and Lung Cancer Awareness Month, the World Health Organization (WHO) emphasizes the impact of various forms of tobacco use on COPD,” Dharani K. Narendra, MD, of Baylor College of Medicine, Houston, said in an interview.
“This article focuses on the different types of tobacco exposure, the health care burden associated with COPD, and the risk of developing lung cancer. It also addresses the high-risk groups, especially youth, underscoring the importance of public education and the implementation of restrictions on tobacco use to combat these growing concerns,” she said.
“Education, awareness, and targeted interventions are essential for smoking cessation and COPD management,” said Dr. Narendra. “These elements are key to informing the public about smoking risks, encouraging behavioral change, and ultimately reducing the incidence of smoking-related diseases,” she emphasized.
The WHO statement called for population-level interventions including brief advice to tobacco users, toll-free quit lines, pharmacological interventions, use of messaging and chatbots to provide quit support, and the WHO quit tobacco mobile app.
“It is imperative that all tobacco users, particularly those living in low- to middle-income countries, have access to comprehensive cessation support aligned with WHO recommendations,” the authors wrote.
Finally, the authors emphasized the need to protect children and teens from the dangers of tobacco use through product regulation and to expose the tobacco industry’s marketing tactics.
“The article offers a comprehensive look at different types of tobacco exposure and their contribution to the development of COPD,” Dr. Narendra told this news organization. “Notably, it presents groundbreaking evidence of a strong association between the use of electronic nicotine delivery systems (ENDS) and heated tobacco products to development of COPD; additionally, it provides valuable guidance on smoking cessation resources for physicians to help patients quit smoking,” she said.
Looking ahead, more research is needed on “developing and sustaining state-specific or population-specific interventions for effective smoking cessation programs, and reducing the burden of COPD,” Dr. Narendra said.
The study by Madison and colleagues was supported by the National Heart, Lung, and Blood Institute, the National Institute of General Medical Science, the U.S. Veterans Affairs Administration, the Cystic Fibrosis Foundation Research Development Program, and the Veterans Affairs Merit grant.
Additional financial support came from Imperial College London, a Wellcome Trust Senior Research Fellowship, and Rosetrees Trust/The Stoneygate Trust.
Dr. Narendra had no financial conflicts to disclose but serves as a member of the editorial board of CHEST Physician.
Reducing exposure to tobacco smoke may reduce the burden of chronic obstructive pulmonary disease, and public health measures are needed, according to a new Tobacco Knowledge Summary from the World Health Organization.
“Smoking is a major risk factor for COPD and leads to airway inflammation and remodeling associated with lung destruction,” and contributes to approximately 70% of COPD cases worldwide, according to the statement.
Types of tobacco exposure include not only traditional smoked tobacco products (cigarettes, cigars, pipes, water pipes, kreteks, and bidis), but also smokeless tobacco, heated tobacco products, and electronic nicotine delivery systems; the addition of chemicals and flavors can increase the appeal of tobacco products and promote addiction, the authors wrote. Hookahs and water pipes “are at least as detrimental to lung health as smoking cigarettes and should not be considered as a safe alternative,” they added.
The risk of COPD extends to new e-cigarette products, the authors noted. A study in the American Journal of Preventive Medicine showed that current users of e-cigarettes had a 75% increased risk of developing COPD compared with individuals who have never used e-cigarettes.
Individuals with COPD also face an increased risk of cardiovascular disease and type 2 diabetes, and smokers with COPD who quit not only improve their COPD but also reduce their risk of developing these conditions, the authors said.
Mechanism of action explored
The authors noted how tobacco smoking may cause COPD when inhaled particles are deposited through the airway.
Growing evidence suggests that extracellular vesicles may play a role in the development of lung disorders such as COPD, and cigarette smoke can have an impact through this channel. A study published in the American Journal of Respiratory and Critical Care Medicine offered evidence of a potential link between exposure to cigarette smoke and the generation of a unique extracellular vesicle population that could promote the development of lung damage. In the study, Matthew C. Madison, MD, of the University of Alabama, Birmingham, and colleagues examined activity in extracellular vesicles from the bronchoalveolar lavage (BAL) fluid of smoke-exposed mice and human smokers who were otherwise healthy.
The researchers found that airway extracellular vesicles in mice or humans exposed to cigarette smoke had the ability to cause rapid lung damage when transferred into naive recipient mice. The results provide a new model that can inform preclinical COPD research, they wrote.
Public health action needed
“In recognition of COPD and Lung Cancer Awareness Month, the World Health Organization (WHO) emphasizes the impact of various forms of tobacco use on COPD,” Dharani K. Narendra, MD, of Baylor College of Medicine, Houston, said in an interview.
“This article focuses on the different types of tobacco exposure, the health care burden associated with COPD, and the risk of developing lung cancer. It also addresses the high-risk groups, especially youth, underscoring the importance of public education and the implementation of restrictions on tobacco use to combat these growing concerns,” she said.
“Education, awareness, and targeted interventions are essential for smoking cessation and COPD management,” said Dr. Narendra. “These elements are key to informing the public about smoking risks, encouraging behavioral change, and ultimately reducing the incidence of smoking-related diseases,” she emphasized.
The WHO statement called for population-level interventions including brief advice to tobacco users, toll-free quit lines, pharmacological interventions, use of messaging and chatbots to provide quit support, and the WHO quit tobacco mobile app.
“It is imperative that all tobacco users, particularly those living in low- to middle-income countries, have access to comprehensive cessation support aligned with WHO recommendations,” the authors wrote.
Finally, the authors emphasized the need to protect children and teens from the dangers of tobacco use through product regulation and to expose the tobacco industry’s marketing tactics.
“The article offers a comprehensive look at different types of tobacco exposure and their contribution to the development of COPD,” Dr. Narendra told this news organization. “Notably, it presents groundbreaking evidence of a strong association between the use of electronic nicotine delivery systems (ENDS) and heated tobacco products to development of COPD; additionally, it provides valuable guidance on smoking cessation resources for physicians to help patients quit smoking,” she said.
Looking ahead, more research is needed on “developing and sustaining state-specific or population-specific interventions for effective smoking cessation programs, and reducing the burden of COPD,” Dr. Narendra said.
The study by Madison and colleagues was supported by the National Heart, Lung, and Blood Institute, the National Institute of General Medical Science, the U.S. Veterans Affairs Administration, the Cystic Fibrosis Foundation Research Development Program, and the Veterans Affairs Merit grant.
Additional financial support came from Imperial College London, a Wellcome Trust Senior Research Fellowship, and Rosetrees Trust/The Stoneygate Trust.
Dr. Narendra had no financial conflicts to disclose but serves as a member of the editorial board of CHEST Physician.
Childhood immunization schedule includes new RSV, mpox, meningococcal, and pneumococcal vaccines
The immunization schedule for children and adolescents, summarized as an American Academy of Pediatrics policy statement in the journal Pediatrics, contains new entries for the monoclonal antibody immunization nirsevimab for respiratory syncytial virus in infants, the maternal RSV vaccine RSVpreF for pregnant people, the mpox vaccine for adolescents, the 2023-2024 COVID-19 vaccine, the 20-valent pneumococcal conjugate vaccine (PCV20), and the pentavalent meningococcal vaccine (MenACWY-TT/MenB-FHbp).
A number of immunizations have been deleted from the 2024 schedule, including the pentavalent meningococcal vaccine MenABCWY because of a discontinuation in its distribution in the United States, the bivalent mRNA COVID-19 vaccines, the diphtheria and tetanus toxoids adsorbed vaccine, the 13-valent pneumococcal conjugate vaccine (PCV13), and the pneumococcal polysaccharide vaccine (PPSV23).
The 2024 childhood and adolescent immunization schedule, also approved by the Centers for Disease Control and Prevention, American Academy of Family Physicians, American College of Obstetricians and Gynecologists, American College of Nurse-Midwives, American Academy of Physician Associates, and National Association of Pediatric Nurse Practitioners, is published each year based on current recommendations that have been approved for use by the Food and Drug Administration.
In a press release, the AAP said the CDC decided to publish the recommendations early to ensure health providers are able to administer immunizations and that they are covered by insurance. They also referenced CDC reports that found vaccination rates for kindergarteners have not bounced back since the beginning of the COVID-19 pandemic, and vaccine exemptions for the 2022-2023 school year were at an “all-time high.”
RSV
New to the schedule are the recently approved RSV monoclonal antibody nirsevimab for infants and the RSV vaccine RSVpreF for pregnant people. According to the CDC’s combined immunization schedule for 2024, the timing of the infant RSV immunization is heavily dependent upon when and whether a RSV vaccine was administered during pregnancy. The RSV vaccine should be routinely given between 32 weeks and 36 weeks of gestation between September and January in most of the United States with the caveat that either the maternal vaccine or the infant immunization is recommended.
Infants born between October and March in most of the United States are eligible for the RSV immunization within 14 days of birth if the pregnant parent did not receive an RSV vaccine during pregnancy, or if the parent received the vaccine in the 14 days prior to birth. For infants born between April and September RSV immunization is recommended prior to the start of RSV season.
The immunization is also recommended for infants who were hospitalized for conditions such as prematurity after birth between October and March, infants aged 8-19 months who are undergoing medical support related to prematurity, infants aged 8-19 months who are severely immunocompromised, and infants aged 9-19 months who are American Indian or Alaska Native, and infants undergoing cardiac surgery with cardiopulmonary bypass.
Mpox
Another new addition to the schedule is mpox, which is recommended for adolescents 18 years or older who are at risk for mpox infection, including gay, bisexual, nonbinary, transgender, or other individuals who have developed a sexually transmitted disease within the last 6 months, had more than one sexual partner, or engaged in sex in a commercial sex venue or public space with confirmed mpox transmission.
Currently, mpox vaccination during pregnancy is not recommended due to a lack of safety data on the vaccine during pregnancy; however, the CDC noted pregnant persons who have been exposed to any of the risk factors above may receive the vaccine.
COVID, influenza, pneumococcal vaccines
The COVID-19 vaccine recommendations were updated to reflect the 2023-2023 formulation of the vaccine. Unvaccinated children between 6 months and 4 years of age will now receive the 2023-2024 formula mRNA vaccines, which includes the two-dose Moderna vaccine and three-dose Pfizer vaccine for use in that age group. Children with a previous history of COVID-19 vaccination are eligible to receive an age-appropriate COVID-19 vaccine from the 2023-2024 formulation, and children between 5-11 years old and 12-18 years old can receive a single dose of an mRNA vaccine regardless of vaccine history; unvaccinated children 12-18 years old are also eligible to receive the two-dose Novavax vaccine.
For influenza, the schedule refers to the Advisory Committee on Immunization Practices recommendations released in August, with a note indicating that individuals with an egg allergy can receive another vaccine recommended for their age group without concerns for safety.
The pneumococcal vaccine recommendations have removed PCV13 completely, with updates on the PCV15, PCV20, and PPSV23 in sections on routine vaccination, catch-up vaccination, and special situations. The poliovirus section has also seen its catch-up section revised with a recommendation to complete a vaccination series in adolescents 18 years old known or suspected to have an incomplete series, and to count trivalent oral poliovirus vaccines and OPV administered before April 2016 toward U.S. vaccination requirements.
‘Timely and necessary’ changes
Michael Pichichero, MD, director of the Rochester (N.Y.) General Hospital Research Institute, said in an interview that the committee that developed the immunization schedule was thorough in its recommendations for children and adolescents.
“The additions are timely and necessary as the landscape of vaccines for children changes,” he said.
Bonnie M. Word, MD, director of the Houston Travel Medicine Clinic, said that the immunization schedule “sets the standard and provides clarification and uniformity for administration of all recommended vaccines for U.S. children.”
The U.S. immunization program “is one of the best success stories in medicine,” Dr. Wood said. She noted it is important for providers to become familiar with these vaccines and their indications “to provide advice and be able to respond to questions of parents and/or patients.
“Often patients spend more time with office staff than the physician. It is helpful to make sure everyone in the office understands the importance of and the rationale for immunizing, so families hear consistent messaging,” she said.
Dr. Pichichero and Dr. Word reported no relevant conflicts of interest.
The immunization schedule for children and adolescents, summarized as an American Academy of Pediatrics policy statement in the journal Pediatrics, contains new entries for the monoclonal antibody immunization nirsevimab for respiratory syncytial virus in infants, the maternal RSV vaccine RSVpreF for pregnant people, the mpox vaccine for adolescents, the 2023-2024 COVID-19 vaccine, the 20-valent pneumococcal conjugate vaccine (PCV20), and the pentavalent meningococcal vaccine (MenACWY-TT/MenB-FHbp).
A number of immunizations have been deleted from the 2024 schedule, including the pentavalent meningococcal vaccine MenABCWY because of a discontinuation in its distribution in the United States, the bivalent mRNA COVID-19 vaccines, the diphtheria and tetanus toxoids adsorbed vaccine, the 13-valent pneumococcal conjugate vaccine (PCV13), and the pneumococcal polysaccharide vaccine (PPSV23).
The 2024 childhood and adolescent immunization schedule, also approved by the Centers for Disease Control and Prevention, American Academy of Family Physicians, American College of Obstetricians and Gynecologists, American College of Nurse-Midwives, American Academy of Physician Associates, and National Association of Pediatric Nurse Practitioners, is published each year based on current recommendations that have been approved for use by the Food and Drug Administration.
In a press release, the AAP said the CDC decided to publish the recommendations early to ensure health providers are able to administer immunizations and that they are covered by insurance. They also referenced CDC reports that found vaccination rates for kindergarteners have not bounced back since the beginning of the COVID-19 pandemic, and vaccine exemptions for the 2022-2023 school year were at an “all-time high.”
RSV
New to the schedule are the recently approved RSV monoclonal antibody nirsevimab for infants and the RSV vaccine RSVpreF for pregnant people. According to the CDC’s combined immunization schedule for 2024, the timing of the infant RSV immunization is heavily dependent upon when and whether a RSV vaccine was administered during pregnancy. The RSV vaccine should be routinely given between 32 weeks and 36 weeks of gestation between September and January in most of the United States with the caveat that either the maternal vaccine or the infant immunization is recommended.
Infants born between October and March in most of the United States are eligible for the RSV immunization within 14 days of birth if the pregnant parent did not receive an RSV vaccine during pregnancy, or if the parent received the vaccine in the 14 days prior to birth. For infants born between April and September RSV immunization is recommended prior to the start of RSV season.
The immunization is also recommended for infants who were hospitalized for conditions such as prematurity after birth between October and March, infants aged 8-19 months who are undergoing medical support related to prematurity, infants aged 8-19 months who are severely immunocompromised, and infants aged 9-19 months who are American Indian or Alaska Native, and infants undergoing cardiac surgery with cardiopulmonary bypass.
Mpox
Another new addition to the schedule is mpox, which is recommended for adolescents 18 years or older who are at risk for mpox infection, including gay, bisexual, nonbinary, transgender, or other individuals who have developed a sexually transmitted disease within the last 6 months, had more than one sexual partner, or engaged in sex in a commercial sex venue or public space with confirmed mpox transmission.
Currently, mpox vaccination during pregnancy is not recommended due to a lack of safety data on the vaccine during pregnancy; however, the CDC noted pregnant persons who have been exposed to any of the risk factors above may receive the vaccine.
COVID, influenza, pneumococcal vaccines
The COVID-19 vaccine recommendations were updated to reflect the 2023-2023 formulation of the vaccine. Unvaccinated children between 6 months and 4 years of age will now receive the 2023-2024 formula mRNA vaccines, which includes the two-dose Moderna vaccine and three-dose Pfizer vaccine for use in that age group. Children with a previous history of COVID-19 vaccination are eligible to receive an age-appropriate COVID-19 vaccine from the 2023-2024 formulation, and children between 5-11 years old and 12-18 years old can receive a single dose of an mRNA vaccine regardless of vaccine history; unvaccinated children 12-18 years old are also eligible to receive the two-dose Novavax vaccine.
For influenza, the schedule refers to the Advisory Committee on Immunization Practices recommendations released in August, with a note indicating that individuals with an egg allergy can receive another vaccine recommended for their age group without concerns for safety.
The pneumococcal vaccine recommendations have removed PCV13 completely, with updates on the PCV15, PCV20, and PPSV23 in sections on routine vaccination, catch-up vaccination, and special situations. The poliovirus section has also seen its catch-up section revised with a recommendation to complete a vaccination series in adolescents 18 years old known or suspected to have an incomplete series, and to count trivalent oral poliovirus vaccines and OPV administered before April 2016 toward U.S. vaccination requirements.
‘Timely and necessary’ changes
Michael Pichichero, MD, director of the Rochester (N.Y.) General Hospital Research Institute, said in an interview that the committee that developed the immunization schedule was thorough in its recommendations for children and adolescents.
“The additions are timely and necessary as the landscape of vaccines for children changes,” he said.
Bonnie M. Word, MD, director of the Houston Travel Medicine Clinic, said that the immunization schedule “sets the standard and provides clarification and uniformity for administration of all recommended vaccines for U.S. children.”
The U.S. immunization program “is one of the best success stories in medicine,” Dr. Wood said. She noted it is important for providers to become familiar with these vaccines and their indications “to provide advice and be able to respond to questions of parents and/or patients.
“Often patients spend more time with office staff than the physician. It is helpful to make sure everyone in the office understands the importance of and the rationale for immunizing, so families hear consistent messaging,” she said.
Dr. Pichichero and Dr. Word reported no relevant conflicts of interest.
The immunization schedule for children and adolescents, summarized as an American Academy of Pediatrics policy statement in the journal Pediatrics, contains new entries for the monoclonal antibody immunization nirsevimab for respiratory syncytial virus in infants, the maternal RSV vaccine RSVpreF for pregnant people, the mpox vaccine for adolescents, the 2023-2024 COVID-19 vaccine, the 20-valent pneumococcal conjugate vaccine (PCV20), and the pentavalent meningococcal vaccine (MenACWY-TT/MenB-FHbp).
A number of immunizations have been deleted from the 2024 schedule, including the pentavalent meningococcal vaccine MenABCWY because of a discontinuation in its distribution in the United States, the bivalent mRNA COVID-19 vaccines, the diphtheria and tetanus toxoids adsorbed vaccine, the 13-valent pneumococcal conjugate vaccine (PCV13), and the pneumococcal polysaccharide vaccine (PPSV23).
The 2024 childhood and adolescent immunization schedule, also approved by the Centers for Disease Control and Prevention, American Academy of Family Physicians, American College of Obstetricians and Gynecologists, American College of Nurse-Midwives, American Academy of Physician Associates, and National Association of Pediatric Nurse Practitioners, is published each year based on current recommendations that have been approved for use by the Food and Drug Administration.
In a press release, the AAP said the CDC decided to publish the recommendations early to ensure health providers are able to administer immunizations and that they are covered by insurance. They also referenced CDC reports that found vaccination rates for kindergarteners have not bounced back since the beginning of the COVID-19 pandemic, and vaccine exemptions for the 2022-2023 school year were at an “all-time high.”
RSV
New to the schedule are the recently approved RSV monoclonal antibody nirsevimab for infants and the RSV vaccine RSVpreF for pregnant people. According to the CDC’s combined immunization schedule for 2024, the timing of the infant RSV immunization is heavily dependent upon when and whether a RSV vaccine was administered during pregnancy. The RSV vaccine should be routinely given between 32 weeks and 36 weeks of gestation between September and January in most of the United States with the caveat that either the maternal vaccine or the infant immunization is recommended.
Infants born between October and March in most of the United States are eligible for the RSV immunization within 14 days of birth if the pregnant parent did not receive an RSV vaccine during pregnancy, or if the parent received the vaccine in the 14 days prior to birth. For infants born between April and September RSV immunization is recommended prior to the start of RSV season.
The immunization is also recommended for infants who were hospitalized for conditions such as prematurity after birth between October and March, infants aged 8-19 months who are undergoing medical support related to prematurity, infants aged 8-19 months who are severely immunocompromised, and infants aged 9-19 months who are American Indian or Alaska Native, and infants undergoing cardiac surgery with cardiopulmonary bypass.
Mpox
Another new addition to the schedule is mpox, which is recommended for adolescents 18 years or older who are at risk for mpox infection, including gay, bisexual, nonbinary, transgender, or other individuals who have developed a sexually transmitted disease within the last 6 months, had more than one sexual partner, or engaged in sex in a commercial sex venue or public space with confirmed mpox transmission.
Currently, mpox vaccination during pregnancy is not recommended due to a lack of safety data on the vaccine during pregnancy; however, the CDC noted pregnant persons who have been exposed to any of the risk factors above may receive the vaccine.
COVID, influenza, pneumococcal vaccines
The COVID-19 vaccine recommendations were updated to reflect the 2023-2023 formulation of the vaccine. Unvaccinated children between 6 months and 4 years of age will now receive the 2023-2024 formula mRNA vaccines, which includes the two-dose Moderna vaccine and three-dose Pfizer vaccine for use in that age group. Children with a previous history of COVID-19 vaccination are eligible to receive an age-appropriate COVID-19 vaccine from the 2023-2024 formulation, and children between 5-11 years old and 12-18 years old can receive a single dose of an mRNA vaccine regardless of vaccine history; unvaccinated children 12-18 years old are also eligible to receive the two-dose Novavax vaccine.
For influenza, the schedule refers to the Advisory Committee on Immunization Practices recommendations released in August, with a note indicating that individuals with an egg allergy can receive another vaccine recommended for their age group without concerns for safety.
The pneumococcal vaccine recommendations have removed PCV13 completely, with updates on the PCV15, PCV20, and PPSV23 in sections on routine vaccination, catch-up vaccination, and special situations. The poliovirus section has also seen its catch-up section revised with a recommendation to complete a vaccination series in adolescents 18 years old known or suspected to have an incomplete series, and to count trivalent oral poliovirus vaccines and OPV administered before April 2016 toward U.S. vaccination requirements.
‘Timely and necessary’ changes
Michael Pichichero, MD, director of the Rochester (N.Y.) General Hospital Research Institute, said in an interview that the committee that developed the immunization schedule was thorough in its recommendations for children and adolescents.
“The additions are timely and necessary as the landscape of vaccines for children changes,” he said.
Bonnie M. Word, MD, director of the Houston Travel Medicine Clinic, said that the immunization schedule “sets the standard and provides clarification and uniformity for administration of all recommended vaccines for U.S. children.”
The U.S. immunization program “is one of the best success stories in medicine,” Dr. Wood said. She noted it is important for providers to become familiar with these vaccines and their indications “to provide advice and be able to respond to questions of parents and/or patients.
“Often patients spend more time with office staff than the physician. It is helpful to make sure everyone in the office understands the importance of and the rationale for immunizing, so families hear consistent messaging,” she said.
Dr. Pichichero and Dr. Word reported no relevant conflicts of interest.
FROM PEDIATRICS