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Catch and Treat a Stealth Diagnosis: Obsessive-Compulsive Disorder
“Allie” is a 16-year-old African American female, presenting to her primary care provider for a routine well-child visit. She gets straight As in school, has a boyfriend, and works as a lifeguard. She is always on her phone using Snapchat, TikTok, and Instagram. Over the past year, it’s been taking her longer to turn off the phone and electronics at night. She needs to close the apps one by one and check the power sources a number of times. In the past few months, this ritual has become longer, includes more checks, and is interfering with sleep. She reports knowing this is abnormal and thinking she is “just kind of crazy” but she cannot stop. Her parents reassure her each evening. They now help her doublecheck that her devices are plugged in at least twice.
Unlike its depiction in the movies, many symptoms of obsessive-compulsive disorder (OCD) happen internally. Often patients are aware that these are “not normal” and cover up their experiences. It can be hard for treaters to learn about these challenges. Children spend years suffering from OCD and even regularly attend nonspecific therapy without being diagnosed. However, 
OCD impacts 2.3% of the population in their lifetime but more than 28% of people report symptoms consistent with OCD traits.1 OCD symptoms have increased since the pandemic2 so it is showing up in primary care more frequently. Younger patients meet criteria when their symptoms on the Children’s Yale-Brown Obsessive Compulsive Scale (CY-BOCS) are sufficiently present, and impact the ability to function. The youngest patients with OCD are more likely to be male1 and children are most likely to be identified between ages 8-12 and during the later teenage years,3 although symptoms can occur at any time in life.
Usually, symptom onset happens gradually and then waxes and wanes. Often OCD has been present over months to years but not identified until they reach a functional tipping point. Alternatively, symptoms caused by PANDAS/PANS occur out of the blue and should be treated according to infectious disease/autoimmune workup protocols. Other differential diagnosis for OCD include other anxiety disorders, mood disorders, eating disorders, psychotic disorders, and other compulsive behaviors. OCD, tics, and ADHD are a combination seen more frequently in younger patients.4 Comorbidities frequently occur, including anxiety disorders, mood disorders, impulse control disorders, and substance use disorders.1 PTSD frequently presents with comorbid OCD symptoms.1 Finding the underlying cause is key to effective treatment.
How do I identify OCD in primary care?
Administer the CY-BOCS if these symptoms cause inability to function. The cut off for moderate symptoms is a score of 16 or above. Like all mental health screening, clinical judgment should be used to interpret the score. Many therapists do not screen for OCD.
How do I treat OCD in primary care?
Exposure Therapy with Response Prevention (ERP) is the gold-standard therapy and medication management is most effective when paired with ERP. ERP helps patients list their obsessions and compulsions in order of how much anxiety they cause, then work on gradual exposure starting with those that cause the least amount of anxiety. Picking up on any sneaky internal or external “responses” is important. An example response could include externally checking the rearview mirror to make sure the patient didn’t run over a puppy after they hit a pothole, or internally reassuring themselves. This “response prevention” can be the trickiest part of the therapy and is key to efficacy.
How to access ERP?
The International OCD Foundation offers a list of therapists trained in ERP, and most states’ psychiatry access lines can help primary care providers find available targeted resources. Despite these resources, it can be frustrating to help a family try find any available therapist who takes insurance, let alone a specialist. A recent JAMA article review found that IInternet-based treatment with both therapist- and non-therapist–guided interventions resulted in symptom improvements.2 Interventions that include parents are most helpful for children.
Other therapy options include:
- MGH/McLean/ (iocd.org) hosts an online, low cost ($65 per family) OCD camp for those age 6-17 and caregivers found here.
- Many workbooks are available, Standing Up to OCD Workbook for Kids by Tyson Reuter, PhD, is one good option.
- A book for parents about how not to accidentally reinforce anxiety is Anxious Kids, Anxious Parents: 7 Ways to Stop the Worry Cycle by Lynn Lyons and Reid Wilson.
- Sometimes a therapist without expertise can work with families using workbooks and other supports to help with ERP.
Medication options
Medications alone do not cure OCD, but can help patients better participate in ERP therapy. When the most likely cause of OCD symptoms is OCD (ruling out family history of bipolar or other psychiatric illness), using SSRIs to treat symptoms is the gold standard for medications. There is FDA approval for sertraline (≥ age 6) and fluoxetine (≥ age 7) as first-line options. If tolerated, up-titrate to efficacy. Clomipramine and fluvoxamine also have FDA approval but have more side effects so are not first line. Citalopram has randomized clinical trial support.5
Allie’s primary care provider administered and scored the CY-BOCS, started her on an SSRI, and up-titrated to efficacy over 4 months. The family signed up for an online OCD camp and learned more about OCD at iocdf.org. They talked with her therapist and worked through an OCD workbook together as no specialist was available. Her parents decreased their reassurances. Because of her primary care provider’s intervention, Allie got the care she required and was better prepared to face future exacerbations.
Dr. Spottswood is a child psychiatrist practicing in an integrated care clinic at the Community Health Centers of Burlington, Vermont. She is the medical director of the Vermont Child Psychiatry Access Program and a clinical assistant professor in the department of psychiatry at the University of Vermont.
References
1. Ruscio AM et al. The epidemiology of obsessive-compulsive disorder in the National Comorbidity Survey Replication. Mol Psychiatry. 2010 Jan;15(1):53-63. doi: 10.1038/mp.2008.94.
2. Lattie EG, Stamatis CA. Focusing on accessibility of evidence-based treatments for obsessive-compulsive disorder. JAMA Netw Open. 2022;5(3):e221978. doi: 10.1001/jamanetworkopen.2022.1978.
3. International OCD Foundation pediatric OCD for professionals. https://kids.iocdf.org/professionals/md/pediatric-ocd/. Accessed December 27, 2023.
4. American Psychiatric Association. (2013). Diagnostic and statistical manual of mental disorders (5th ed.). 2013. https://doi.org/10.1176/appi.books.9780890425596. Accessed December 27, 2023.5. Hilt RJ, Nussbaum AM. DSM-5 pocket guide to child and adolescent mental health. Arlington, Virginia: American Psychiatric Association Publishing, 2015.
“Allie” is a 16-year-old African American female, presenting to her primary care provider for a routine well-child visit. She gets straight As in school, has a boyfriend, and works as a lifeguard. She is always on her phone using Snapchat, TikTok, and Instagram. Over the past year, it’s been taking her longer to turn off the phone and electronics at night. She needs to close the apps one by one and check the power sources a number of times. In the past few months, this ritual has become longer, includes more checks, and is interfering with sleep. She reports knowing this is abnormal and thinking she is “just kind of crazy” but she cannot stop. Her parents reassure her each evening. They now help her doublecheck that her devices are plugged in at least twice.
Unlike its depiction in the movies, many symptoms of obsessive-compulsive disorder (OCD) happen internally. Often patients are aware that these are “not normal” and cover up their experiences. It can be hard for treaters to learn about these challenges. Children spend years suffering from OCD and even regularly attend nonspecific therapy without being diagnosed. However,
OCD impacts 2.3% of the population in their lifetime but more than 28% of people report symptoms consistent with OCD traits.1 OCD symptoms have increased since the pandemic2 so it is showing up in primary care more frequently. Younger patients meet criteria when their symptoms on the Children’s Yale-Brown Obsessive Compulsive Scale (CY-BOCS) are sufficiently present, and impact the ability to function. The youngest patients with OCD are more likely to be male1 and children are most likely to be identified between ages 8-12 and during the later teenage years,3 although symptoms can occur at any time in life.
Usually, symptom onset happens gradually and then waxes and wanes. Often OCD has been present over months to years but not identified until they reach a functional tipping point. Alternatively, symptoms caused by PANDAS/PANS occur out of the blue and should be treated according to infectious disease/autoimmune workup protocols. Other differential diagnosis for OCD include other anxiety disorders, mood disorders, eating disorders, psychotic disorders, and other compulsive behaviors. OCD, tics, and ADHD are a combination seen more frequently in younger patients.4 Comorbidities frequently occur, including anxiety disorders, mood disorders, impulse control disorders, and substance use disorders.1 PTSD frequently presents with comorbid OCD symptoms.1 Finding the underlying cause is key to effective treatment.
How do I identify OCD in primary care?
Administer the CY-BOCS if these symptoms cause inability to function. The cut off for moderate symptoms is a score of 16 or above. Like all mental health screening, clinical judgment should be used to interpret the score. Many therapists do not screen for OCD.
How do I treat OCD in primary care?
Exposure Therapy with Response Prevention (ERP) is the gold-standard therapy and medication management is most effective when paired with ERP. ERP helps patients list their obsessions and compulsions in order of how much anxiety they cause, then work on gradual exposure starting with those that cause the least amount of anxiety. Picking up on any sneaky internal or external “responses” is important. An example response could include externally checking the rearview mirror to make sure the patient didn’t run over a puppy after they hit a pothole, or internally reassuring themselves. This “response prevention” can be the trickiest part of the therapy and is key to efficacy.
How to access ERP?
The International OCD Foundation offers a list of therapists trained in ERP, and most states’ psychiatry access lines can help primary care providers find available targeted resources. Despite these resources, it can be frustrating to help a family try find any available therapist who takes insurance, let alone a specialist. A recent JAMA article review found that IInternet-based treatment with both therapist- and non-therapist–guided interventions resulted in symptom improvements.2 Interventions that include parents are most helpful for children.
Other therapy options include:
- MGH/McLean/ (iocd.org) hosts an online, low cost ($65 per family) OCD camp for those age 6-17 and caregivers found here.
- Many workbooks are available, Standing Up to OCD Workbook for Kids by Tyson Reuter, PhD, is one good option.
- A book for parents about how not to accidentally reinforce anxiety is Anxious Kids, Anxious Parents: 7 Ways to Stop the Worry Cycle by Lynn Lyons and Reid Wilson.
- Sometimes a therapist without expertise can work with families using workbooks and other supports to help with ERP.
Medication options
Medications alone do not cure OCD, but can help patients better participate in ERP therapy. When the most likely cause of OCD symptoms is OCD (ruling out family history of bipolar or other psychiatric illness), using SSRIs to treat symptoms is the gold standard for medications. There is FDA approval for sertraline (≥ age 6) and fluoxetine (≥ age 7) as first-line options. If tolerated, up-titrate to efficacy. Clomipramine and fluvoxamine also have FDA approval but have more side effects so are not first line. Citalopram has randomized clinical trial support.5
Allie’s primary care provider administered and scored the CY-BOCS, started her on an SSRI, and up-titrated to efficacy over 4 months. The family signed up for an online OCD camp and learned more about OCD at iocdf.org. They talked with her therapist and worked through an OCD workbook together as no specialist was available. Her parents decreased their reassurances. Because of her primary care provider’s intervention, Allie got the care she required and was better prepared to face future exacerbations.
Dr. Spottswood is a child psychiatrist practicing in an integrated care clinic at the Community Health Centers of Burlington, Vermont. She is the medical director of the Vermont Child Psychiatry Access Program and a clinical assistant professor in the department of psychiatry at the University of Vermont.
References
1. Ruscio AM et al. The epidemiology of obsessive-compulsive disorder in the National Comorbidity Survey Replication. Mol Psychiatry. 2010 Jan;15(1):53-63. doi: 10.1038/mp.2008.94.
2. Lattie EG, Stamatis CA. Focusing on accessibility of evidence-based treatments for obsessive-compulsive disorder. JAMA Netw Open. 2022;5(3):e221978. doi: 10.1001/jamanetworkopen.2022.1978.
3. International OCD Foundation pediatric OCD for professionals. https://kids.iocdf.org/professionals/md/pediatric-ocd/. Accessed December 27, 2023.
4. American Psychiatric Association. (2013). Diagnostic and statistical manual of mental disorders (5th ed.). 2013. https://doi.org/10.1176/appi.books.9780890425596. Accessed December 27, 2023.5. Hilt RJ, Nussbaum AM. DSM-5 pocket guide to child and adolescent mental health. Arlington, Virginia: American Psychiatric Association Publishing, 2015.
“Allie” is a 16-year-old African American female, presenting to her primary care provider for a routine well-child visit. She gets straight As in school, has a boyfriend, and works as a lifeguard. She is always on her phone using Snapchat, TikTok, and Instagram. Over the past year, it’s been taking her longer to turn off the phone and electronics at night. She needs to close the apps one by one and check the power sources a number of times. In the past few months, this ritual has become longer, includes more checks, and is interfering with sleep. She reports knowing this is abnormal and thinking she is “just kind of crazy” but she cannot stop. Her parents reassure her each evening. They now help her doublecheck that her devices are plugged in at least twice.
Unlike its depiction in the movies, many symptoms of obsessive-compulsive disorder (OCD) happen internally. Often patients are aware that these are “not normal” and cover up their experiences. It can be hard for treaters to learn about these challenges. Children spend years suffering from OCD and even regularly attend nonspecific therapy without being diagnosed. However,
OCD impacts 2.3% of the population in their lifetime but more than 28% of people report symptoms consistent with OCD traits.1 OCD symptoms have increased since the pandemic2 so it is showing up in primary care more frequently. Younger patients meet criteria when their symptoms on the Children’s Yale-Brown Obsessive Compulsive Scale (CY-BOCS) are sufficiently present, and impact the ability to function. The youngest patients with OCD are more likely to be male1 and children are most likely to be identified between ages 8-12 and during the later teenage years,3 although symptoms can occur at any time in life.
Usually, symptom onset happens gradually and then waxes and wanes. Often OCD has been present over months to years but not identified until they reach a functional tipping point. Alternatively, symptoms caused by PANDAS/PANS occur out of the blue and should be treated according to infectious disease/autoimmune workup protocols. Other differential diagnosis for OCD include other anxiety disorders, mood disorders, eating disorders, psychotic disorders, and other compulsive behaviors. OCD, tics, and ADHD are a combination seen more frequently in younger patients.4 Comorbidities frequently occur, including anxiety disorders, mood disorders, impulse control disorders, and substance use disorders.1 PTSD frequently presents with comorbid OCD symptoms.1 Finding the underlying cause is key to effective treatment.
How do I identify OCD in primary care?
Administer the CY-BOCS if these symptoms cause inability to function. The cut off for moderate symptoms is a score of 16 or above. Like all mental health screening, clinical judgment should be used to interpret the score. Many therapists do not screen for OCD.
How do I treat OCD in primary care?
Exposure Therapy with Response Prevention (ERP) is the gold-standard therapy and medication management is most effective when paired with ERP. ERP helps patients list their obsessions and compulsions in order of how much anxiety they cause, then work on gradual exposure starting with those that cause the least amount of anxiety. Picking up on any sneaky internal or external “responses” is important. An example response could include externally checking the rearview mirror to make sure the patient didn’t run over a puppy after they hit a pothole, or internally reassuring themselves. This “response prevention” can be the trickiest part of the therapy and is key to efficacy.
How to access ERP?
The International OCD Foundation offers a list of therapists trained in ERP, and most states’ psychiatry access lines can help primary care providers find available targeted resources. Despite these resources, it can be frustrating to help a family try find any available therapist who takes insurance, let alone a specialist. A recent JAMA article review found that IInternet-based treatment with both therapist- and non-therapist–guided interventions resulted in symptom improvements.2 Interventions that include parents are most helpful for children.
Other therapy options include:
- MGH/McLean/ (iocd.org) hosts an online, low cost ($65 per family) OCD camp for those age 6-17 and caregivers found here.
- Many workbooks are available, Standing Up to OCD Workbook for Kids by Tyson Reuter, PhD, is one good option.
- A book for parents about how not to accidentally reinforce anxiety is Anxious Kids, Anxious Parents: 7 Ways to Stop the Worry Cycle by Lynn Lyons and Reid Wilson.
- Sometimes a therapist without expertise can work with families using workbooks and other supports to help with ERP.
Medication options
Medications alone do not cure OCD, but can help patients better participate in ERP therapy. When the most likely cause of OCD symptoms is OCD (ruling out family history of bipolar or other psychiatric illness), using SSRIs to treat symptoms is the gold standard for medications. There is FDA approval for sertraline (≥ age 6) and fluoxetine (≥ age 7) as first-line options. If tolerated, up-titrate to efficacy. Clomipramine and fluvoxamine also have FDA approval but have more side effects so are not first line. Citalopram has randomized clinical trial support.5
Allie’s primary care provider administered and scored the CY-BOCS, started her on an SSRI, and up-titrated to efficacy over 4 months. The family signed up for an online OCD camp and learned more about OCD at iocdf.org. They talked with her therapist and worked through an OCD workbook together as no specialist was available. Her parents decreased their reassurances. Because of her primary care provider’s intervention, Allie got the care she required and was better prepared to face future exacerbations.
Dr. Spottswood is a child psychiatrist practicing in an integrated care clinic at the Community Health Centers of Burlington, Vermont. She is the medical director of the Vermont Child Psychiatry Access Program and a clinical assistant professor in the department of psychiatry at the University of Vermont.
References
1. Ruscio AM et al. The epidemiology of obsessive-compulsive disorder in the National Comorbidity Survey Replication. Mol Psychiatry. 2010 Jan;15(1):53-63. doi: 10.1038/mp.2008.94.
2. Lattie EG, Stamatis CA. Focusing on accessibility of evidence-based treatments for obsessive-compulsive disorder. JAMA Netw Open. 2022;5(3):e221978. doi: 10.1001/jamanetworkopen.2022.1978.
3. International OCD Foundation pediatric OCD for professionals. https://kids.iocdf.org/professionals/md/pediatric-ocd/. Accessed December 27, 2023.
4. American Psychiatric Association. (2013). Diagnostic and statistical manual of mental disorders (5th ed.). 2013. https://doi.org/10.1176/appi.books.9780890425596. Accessed December 27, 2023.5. Hilt RJ, Nussbaum AM. DSM-5 pocket guide to child and adolescent mental health. Arlington, Virginia: American Psychiatric Association Publishing, 2015.
‘Milestone’ Study Zeros in on 5-Year Safety Data From Upadacitinib Trials
, underscoring the medication’s stable safety profile over an extended duration.
Those are among the key findings from an integrated analysis of long-term upadacitinib use presented by Christopher G. Bunick, MD, PhD, during a late-breaking abstract session at the Revolutionizing Atopic Dermatitis Virtual Conference. Upadacitinib (Rinvoq) is an oral Janus kinase (JAK) inhibitor, approved by the Food and Drug Administration for adults and pediatric patients aged 12 years of age and older with refractory, moderate to severe AD in January 2022.
“What makes this study special is that these patients are followed for 260 weeks, or 5 years, and it encompasses over 7,000 patient-years of exposure,” said Dr. Bunick, associate professor of dermatology at Yale University, New Haven, Connecticut. “This is a milestone because it’s the longest safety study ever published for any systemic drug for AD.”
He and his colleagues evaluated the safety data for up to 5 years of upadacitinib 15 mg and 30 mg use in adolescents and adults with moderate to severe AD, based on the results of integrated data from three ongoing global multicenter phase 3 trials: Measure Up 1, Measure Up 2, and AD Up. Patients in the trials were randomized 1:1:1 to receive oral upadacitinib 15 mg, upadacitinib 30 mg, or placebo once daily alone (Measure Up 1 and 2) or with concomitant topical corticosteroids (AD Up). At week 16, patients receiving 15 mg or 30 mg upadacitinib during the double-blind period continued their assigned treatment in the blinded extension (BE) period, whereas patients receiving placebo were randomized 1:1 to receive either 15 mg or 30 mg upadacitinib in the BE period. The integrated analysis included 2683 patients (529 adolescents and 2154 adults) who received at least one dose of upadacitinib. Of these, 1337 received the 15-mg dose, while 1346 received the 30-mg dose. The researchers analyzed treatment-emergent events of special interest as exposure-adjusted rates per 100 patient-years (PY) for the entire treatment period to adjust for potentially different follow-up durations.
According to Dr. Bunick, researchers often refer to “100 patient-years” in safety analyses to measure how common certain events are. “It is a straightforward way to convey the collective experience of the study’s participants over time,” he told this news organization. “For instance, if 100 patients are each monitored for 1 year, or 50 patients for 2 years each, both scenarios amount to 100 patient-years. This metric allows clinicians to understand how often certain adverse events occur across a diverse group over a specific time frame, providing a clear picture of long-term safety.”
Upadacitinib trials in atopic dermatitis have included diverse patient groups with varying risk factors. “Patients were not cherry-picked,” he said. “What I mean by that is that about 50% of patients enrolled in these trials had, at baseline, at least one cardiovascular risk factor: about 30% used tobacco; 10% had hypertension, and 5% had a history of a cardiovascular event.” In addition, about 15% were over age 50 with one cardiovascular risk factor and about 20% had a body mass index (BMI) greater than 30 kg/m2. Among women in the study, about 20% were on oral contraceptives, yet none developed a venous thromboembolism (VTE).
In the integrated analysis, the rate of treatment-emergent adverse events that led to discontinuation of upadacitinib was about 4.2 events per 100 PY, “meaning that this medicine shows durability,” Dr. Bunick said. “Very few people are discontinuing due to adverse events.”
Serious and opportunistic infections ranged from 1.6 to 2.8 events per 100 PY, but these were stable across the 1- to 5-year time points. The rates of active TB were less than 0.1 per 100 PY, while the rates of herpes zoster ranged from 3.5 to 5.5 events per 100 PY. “The key take-home point here is that 5% or less of the patients at baseline had received the shingles vaccine, so it’s very important to talk to patients about receiving the shingles vaccine before they go on upadacitinib,” Dr. Bunick advised, because “this could reduce risk of herpes zoster occurring in upadacitinib-treated patients substantially.”
In other findings, incidence rates of nonmelanoma skin cancer (NMSC) ranged between 0.3 and 0.4 per 100 PY, while the rate of malignancy excluding NMSC ranged between 0.3 and 0.4 per 100 PY. Meanwhile, the rates of gastrointestinal perforations and VTE stood at 0.1 per 100 PY or lower, and MACE incidence rates ranged from 0.1 to 0.2 per 100 PY.
During his presentation, Dr. Bunick compared findings related to malignancy (excluding NMSC), MACE, and VTE to other published real-world background rates observed in moderate to severe AD populations. He noted that, while the malignancy rate in the current trial ranged from 0.3 to 0.4 per 100 PY, an observational study of more than 66,000 AD patients in the United Kingdom reported a malignancy (excluding NMSC) background incidence rate of 0.33 per 100 PY, and SEER data estimate that the malignancy incidence rate in the US general population is 0.45 per 100 PY. “Therefore, patients on upadacitinib at the 5-year mark are right at the AD population baseline risk,” he said.
And while the incidence rate of MACE in the current trial ranged from less than 0.1 to 0.2 per 100 PY, the background incidence rate of MACE in a Danish observational study of more than 2,500 patients with moderate to severe AD was 0.63 per 100 PY. “This suggests that there may be an anti-inflammatory and even a cardiovascular protective effect for patients on upadacitinib,” Dr. Bunick said.
As for VTE, the incidence rate in the current trial was 0.1 per 100 PY, but VTE background incidence rate observed in a moderate to severe AD population in the United States is 0.31 per 100 PY. “Again, this suggests anti-inflammatory and cardiovascular protective effects of upadacitinib in AD patients at the 5-year mark,” he said. “Reporting of MACE, VTE, and malignancy (excluding NMSC) in upadacitinib phase 3 clinical trials for AD generally reflects the background observations of these events in the AD population.”
He acknowledged certain limitations of the study, including the fact that observational data may overestimate the risk of adverse events.
Discussing the incidence rates for MACE, VTE, and malignancy in upadacitinib AD trials, Dr. Bunick remarked, “these are rock-bottom rates that have been low through 5 years of treatment.”
Dr. Bunick disclosed that he has received grant or research support from AbbVie (the manufacturer of upadacitinib), Almirall, Ortho Dermatologics, Timber, and Palvella. He is also a consultant and/or an adviser to AbbVie, Almirall, Apogee, Connect Bropharma, Arcutis, Eli Lilly, Novartis, Pfizer, Sanofi-Regeneron, Ortho Dermatologics, Leo Pharma, and UCB.
, underscoring the medication’s stable safety profile over an extended duration.
Those are among the key findings from an integrated analysis of long-term upadacitinib use presented by Christopher G. Bunick, MD, PhD, during a late-breaking abstract session at the Revolutionizing Atopic Dermatitis Virtual Conference. Upadacitinib (Rinvoq) is an oral Janus kinase (JAK) inhibitor, approved by the Food and Drug Administration for adults and pediatric patients aged 12 years of age and older with refractory, moderate to severe AD in January 2022.
“What makes this study special is that these patients are followed for 260 weeks, or 5 years, and it encompasses over 7,000 patient-years of exposure,” said Dr. Bunick, associate professor of dermatology at Yale University, New Haven, Connecticut. “This is a milestone because it’s the longest safety study ever published for any systemic drug for AD.”
He and his colleagues evaluated the safety data for up to 5 years of upadacitinib 15 mg and 30 mg use in adolescents and adults with moderate to severe AD, based on the results of integrated data from three ongoing global multicenter phase 3 trials: Measure Up 1, Measure Up 2, and AD Up. Patients in the trials were randomized 1:1:1 to receive oral upadacitinib 15 mg, upadacitinib 30 mg, or placebo once daily alone (Measure Up 1 and 2) or with concomitant topical corticosteroids (AD Up). At week 16, patients receiving 15 mg or 30 mg upadacitinib during the double-blind period continued their assigned treatment in the blinded extension (BE) period, whereas patients receiving placebo were randomized 1:1 to receive either 15 mg or 30 mg upadacitinib in the BE period. The integrated analysis included 2683 patients (529 adolescents and 2154 adults) who received at least one dose of upadacitinib. Of these, 1337 received the 15-mg dose, while 1346 received the 30-mg dose. The researchers analyzed treatment-emergent events of special interest as exposure-adjusted rates per 100 patient-years (PY) for the entire treatment period to adjust for potentially different follow-up durations.
According to Dr. Bunick, researchers often refer to “100 patient-years” in safety analyses to measure how common certain events are. “It is a straightforward way to convey the collective experience of the study’s participants over time,” he told this news organization. “For instance, if 100 patients are each monitored for 1 year, or 50 patients for 2 years each, both scenarios amount to 100 patient-years. This metric allows clinicians to understand how often certain adverse events occur across a diverse group over a specific time frame, providing a clear picture of long-term safety.”
Upadacitinib trials in atopic dermatitis have included diverse patient groups with varying risk factors. “Patients were not cherry-picked,” he said. “What I mean by that is that about 50% of patients enrolled in these trials had, at baseline, at least one cardiovascular risk factor: about 30% used tobacco; 10% had hypertension, and 5% had a history of a cardiovascular event.” In addition, about 15% were over age 50 with one cardiovascular risk factor and about 20% had a body mass index (BMI) greater than 30 kg/m2. Among women in the study, about 20% were on oral contraceptives, yet none developed a venous thromboembolism (VTE).
In the integrated analysis, the rate of treatment-emergent adverse events that led to discontinuation of upadacitinib was about 4.2 events per 100 PY, “meaning that this medicine shows durability,” Dr. Bunick said. “Very few people are discontinuing due to adverse events.”
Serious and opportunistic infections ranged from 1.6 to 2.8 events per 100 PY, but these were stable across the 1- to 5-year time points. The rates of active TB were less than 0.1 per 100 PY, while the rates of herpes zoster ranged from 3.5 to 5.5 events per 100 PY. “The key take-home point here is that 5% or less of the patients at baseline had received the shingles vaccine, so it’s very important to talk to patients about receiving the shingles vaccine before they go on upadacitinib,” Dr. Bunick advised, because “this could reduce risk of herpes zoster occurring in upadacitinib-treated patients substantially.”
In other findings, incidence rates of nonmelanoma skin cancer (NMSC) ranged between 0.3 and 0.4 per 100 PY, while the rate of malignancy excluding NMSC ranged between 0.3 and 0.4 per 100 PY. Meanwhile, the rates of gastrointestinal perforations and VTE stood at 0.1 per 100 PY or lower, and MACE incidence rates ranged from 0.1 to 0.2 per 100 PY.
During his presentation, Dr. Bunick compared findings related to malignancy (excluding NMSC), MACE, and VTE to other published real-world background rates observed in moderate to severe AD populations. He noted that, while the malignancy rate in the current trial ranged from 0.3 to 0.4 per 100 PY, an observational study of more than 66,000 AD patients in the United Kingdom reported a malignancy (excluding NMSC) background incidence rate of 0.33 per 100 PY, and SEER data estimate that the malignancy incidence rate in the US general population is 0.45 per 100 PY. “Therefore, patients on upadacitinib at the 5-year mark are right at the AD population baseline risk,” he said.
And while the incidence rate of MACE in the current trial ranged from less than 0.1 to 0.2 per 100 PY, the background incidence rate of MACE in a Danish observational study of more than 2,500 patients with moderate to severe AD was 0.63 per 100 PY. “This suggests that there may be an anti-inflammatory and even a cardiovascular protective effect for patients on upadacitinib,” Dr. Bunick said.
As for VTE, the incidence rate in the current trial was 0.1 per 100 PY, but VTE background incidence rate observed in a moderate to severe AD population in the United States is 0.31 per 100 PY. “Again, this suggests anti-inflammatory and cardiovascular protective effects of upadacitinib in AD patients at the 5-year mark,” he said. “Reporting of MACE, VTE, and malignancy (excluding NMSC) in upadacitinib phase 3 clinical trials for AD generally reflects the background observations of these events in the AD population.”
He acknowledged certain limitations of the study, including the fact that observational data may overestimate the risk of adverse events.
Discussing the incidence rates for MACE, VTE, and malignancy in upadacitinib AD trials, Dr. Bunick remarked, “these are rock-bottom rates that have been low through 5 years of treatment.”
Dr. Bunick disclosed that he has received grant or research support from AbbVie (the manufacturer of upadacitinib), Almirall, Ortho Dermatologics, Timber, and Palvella. He is also a consultant and/or an adviser to AbbVie, Almirall, Apogee, Connect Bropharma, Arcutis, Eli Lilly, Novartis, Pfizer, Sanofi-Regeneron, Ortho Dermatologics, Leo Pharma, and UCB.
, underscoring the medication’s stable safety profile over an extended duration.
Those are among the key findings from an integrated analysis of long-term upadacitinib use presented by Christopher G. Bunick, MD, PhD, during a late-breaking abstract session at the Revolutionizing Atopic Dermatitis Virtual Conference. Upadacitinib (Rinvoq) is an oral Janus kinase (JAK) inhibitor, approved by the Food and Drug Administration for adults and pediatric patients aged 12 years of age and older with refractory, moderate to severe AD in January 2022.
“What makes this study special is that these patients are followed for 260 weeks, or 5 years, and it encompasses over 7,000 patient-years of exposure,” said Dr. Bunick, associate professor of dermatology at Yale University, New Haven, Connecticut. “This is a milestone because it’s the longest safety study ever published for any systemic drug for AD.”
He and his colleagues evaluated the safety data for up to 5 years of upadacitinib 15 mg and 30 mg use in adolescents and adults with moderate to severe AD, based on the results of integrated data from three ongoing global multicenter phase 3 trials: Measure Up 1, Measure Up 2, and AD Up. Patients in the trials were randomized 1:1:1 to receive oral upadacitinib 15 mg, upadacitinib 30 mg, or placebo once daily alone (Measure Up 1 and 2) or with concomitant topical corticosteroids (AD Up). At week 16, patients receiving 15 mg or 30 mg upadacitinib during the double-blind period continued their assigned treatment in the blinded extension (BE) period, whereas patients receiving placebo were randomized 1:1 to receive either 15 mg or 30 mg upadacitinib in the BE period. The integrated analysis included 2683 patients (529 adolescents and 2154 adults) who received at least one dose of upadacitinib. Of these, 1337 received the 15-mg dose, while 1346 received the 30-mg dose. The researchers analyzed treatment-emergent events of special interest as exposure-adjusted rates per 100 patient-years (PY) for the entire treatment period to adjust for potentially different follow-up durations.
According to Dr. Bunick, researchers often refer to “100 patient-years” in safety analyses to measure how common certain events are. “It is a straightforward way to convey the collective experience of the study’s participants over time,” he told this news organization. “For instance, if 100 patients are each monitored for 1 year, or 50 patients for 2 years each, both scenarios amount to 100 patient-years. This metric allows clinicians to understand how often certain adverse events occur across a diverse group over a specific time frame, providing a clear picture of long-term safety.”
Upadacitinib trials in atopic dermatitis have included diverse patient groups with varying risk factors. “Patients were not cherry-picked,” he said. “What I mean by that is that about 50% of patients enrolled in these trials had, at baseline, at least one cardiovascular risk factor: about 30% used tobacco; 10% had hypertension, and 5% had a history of a cardiovascular event.” In addition, about 15% were over age 50 with one cardiovascular risk factor and about 20% had a body mass index (BMI) greater than 30 kg/m2. Among women in the study, about 20% were on oral contraceptives, yet none developed a venous thromboembolism (VTE).
In the integrated analysis, the rate of treatment-emergent adverse events that led to discontinuation of upadacitinib was about 4.2 events per 100 PY, “meaning that this medicine shows durability,” Dr. Bunick said. “Very few people are discontinuing due to adverse events.”
Serious and opportunistic infections ranged from 1.6 to 2.8 events per 100 PY, but these were stable across the 1- to 5-year time points. The rates of active TB were less than 0.1 per 100 PY, while the rates of herpes zoster ranged from 3.5 to 5.5 events per 100 PY. “The key take-home point here is that 5% or less of the patients at baseline had received the shingles vaccine, so it’s very important to talk to patients about receiving the shingles vaccine before they go on upadacitinib,” Dr. Bunick advised, because “this could reduce risk of herpes zoster occurring in upadacitinib-treated patients substantially.”
In other findings, incidence rates of nonmelanoma skin cancer (NMSC) ranged between 0.3 and 0.4 per 100 PY, while the rate of malignancy excluding NMSC ranged between 0.3 and 0.4 per 100 PY. Meanwhile, the rates of gastrointestinal perforations and VTE stood at 0.1 per 100 PY or lower, and MACE incidence rates ranged from 0.1 to 0.2 per 100 PY.
During his presentation, Dr. Bunick compared findings related to malignancy (excluding NMSC), MACE, and VTE to other published real-world background rates observed in moderate to severe AD populations. He noted that, while the malignancy rate in the current trial ranged from 0.3 to 0.4 per 100 PY, an observational study of more than 66,000 AD patients in the United Kingdom reported a malignancy (excluding NMSC) background incidence rate of 0.33 per 100 PY, and SEER data estimate that the malignancy incidence rate in the US general population is 0.45 per 100 PY. “Therefore, patients on upadacitinib at the 5-year mark are right at the AD population baseline risk,” he said.
And while the incidence rate of MACE in the current trial ranged from less than 0.1 to 0.2 per 100 PY, the background incidence rate of MACE in a Danish observational study of more than 2,500 patients with moderate to severe AD was 0.63 per 100 PY. “This suggests that there may be an anti-inflammatory and even a cardiovascular protective effect for patients on upadacitinib,” Dr. Bunick said.
As for VTE, the incidence rate in the current trial was 0.1 per 100 PY, but VTE background incidence rate observed in a moderate to severe AD population in the United States is 0.31 per 100 PY. “Again, this suggests anti-inflammatory and cardiovascular protective effects of upadacitinib in AD patients at the 5-year mark,” he said. “Reporting of MACE, VTE, and malignancy (excluding NMSC) in upadacitinib phase 3 clinical trials for AD generally reflects the background observations of these events in the AD population.”
He acknowledged certain limitations of the study, including the fact that observational data may overestimate the risk of adverse events.
Discussing the incidence rates for MACE, VTE, and malignancy in upadacitinib AD trials, Dr. Bunick remarked, “these are rock-bottom rates that have been low through 5 years of treatment.”
Dr. Bunick disclosed that he has received grant or research support from AbbVie (the manufacturer of upadacitinib), Almirall, Ortho Dermatologics, Timber, and Palvella. He is also a consultant and/or an adviser to AbbVie, Almirall, Apogee, Connect Bropharma, Arcutis, Eli Lilly, Novartis, Pfizer, Sanofi-Regeneron, Ortho Dermatologics, Leo Pharma, and UCB.
FROM RAD 2023
Too Little and Too Late with Obesity Prevention
As we begin to find our way in the new world of obesity management, questions continue to surface more quickly than answers. This isn’t surprising, as we are being asked to view obesity as a disease when for decades the general consensus has been that overweight people are simply will power deficient.
Are the new drugs as effective as we are told by the patients and physicians who have had some experience using and prescribing them? Will they continue to be effective in the very long run? Will their safety record hold up over time? And for those of us in pediatrics, what will be their role for children? As a group we tend to be cautious about drugs that haven’t been thoroughly tested in children. How many years will it take before we feel comfortable with obesity drugs? And, of course, we should be asking ourselves the same questions about bariatric surgery.
Fortunately, while the media spotlight has been focused on the treatment arm of our obesity strategy, there are still some folks looking at what has been up to now the discouraging prospects for prevention. The U.S. Preventive Services Task Force (USPSTF) has recently released a draft of its recommendations that includes evidence supporting the effectiveness of “intensive behavioral interventions” (defined as a minimum of 26 hours of counseling). In reviewing data from nearly 60 randomized controlled trials, which included more than 10,000 children, the task force found that It should be noted that the USPSTF gave the intervention package only a B grade, which means that the agency found evidence of high certainty of a moderate benefit over an unspecified time period. Certainly, not a ringing endorsement.
While I think we must applaud the diligent efforts of the task force and its commitment to prevention, I fear that the strategy is too little too late. That being said, I am willing to accept the idea that targeting age 6 for intensive counseling may qualify for the better-late-than-never category. The task force acknowledges that procuring the resources given our already understaffed mental health clinics is going to be difficult and expensive. I would add that it will be so costly in time and money as to be unrealistic.
Based on my observations of thousands of children, the scaffolding of habits, diet, and preference for inactivity that underly obesity has already been laid by age 6. Are we prepared to shoulder our already overburdened school systems in an attempt to reconfigure this foundation of an obesogenic lifestyle? An effort on this scale after children have been sent off to first grade is doomed to failure.
A recent review of data reported by the CDC and reviewed in the journal Pediatrics reveals that about 2% of children receiving federal assistance from the WIC program are severely obese. It is probably safe to say that these preschoolers represent just the tip of a very concerning iceberg.
By waiting until age 6, we would increase the risk of further stigmatizing the obese child. What will he tell his peers when he is taken out of school or misses a playdate because he has to meet with his “obesity counselor”?
If we are going to take obesity prevention seriously and spend time and money in counseling, doesn’t it make more sense to invest this effort on the parents and the home situation when the child is still under their influence? We must be prepared to unwrap and employ an “intensive behavioral package” the first time we see evidence that the child’s growth chart is heading in an unhealthy direction.
This won’t always be easy. I can recall seeing a 4-year-old whose weight had risen dramatically from her previous curve in the year since her 3-year checkup. The answer became obvious when I discovered that her grandmother, for whom baking was a passion, had taken over as her daycare provider. Arriving at a solution that kept the family on speaking terms took some tact, but it was one of my rare successes in obesity prevention. And, it worked because of early intervention.
Thank you USPSTF, but 6 years is too late.
Dr. Wilkoff practiced primary care pediatrics in Brunswick, Maine, for nearly 40 years. He has authored several books on behavioral pediatrics, including “How to Say No to Your Toddler.” Other than a Littman stethoscope he accepted as a first-year medical student in 1966, Dr. Wilkoff reports having nothing to disclose. Email him at [email protected].
As we begin to find our way in the new world of obesity management, questions continue to surface more quickly than answers. This isn’t surprising, as we are being asked to view obesity as a disease when for decades the general consensus has been that overweight people are simply will power deficient.
Are the new drugs as effective as we are told by the patients and physicians who have had some experience using and prescribing them? Will they continue to be effective in the very long run? Will their safety record hold up over time? And for those of us in pediatrics, what will be their role for children? As a group we tend to be cautious about drugs that haven’t been thoroughly tested in children. How many years will it take before we feel comfortable with obesity drugs? And, of course, we should be asking ourselves the same questions about bariatric surgery.
Fortunately, while the media spotlight has been focused on the treatment arm of our obesity strategy, there are still some folks looking at what has been up to now the discouraging prospects for prevention. The U.S. Preventive Services Task Force (USPSTF) has recently released a draft of its recommendations that includes evidence supporting the effectiveness of “intensive behavioral interventions” (defined as a minimum of 26 hours of counseling). In reviewing data from nearly 60 randomized controlled trials, which included more than 10,000 children, the task force found that It should be noted that the USPSTF gave the intervention package only a B grade, which means that the agency found evidence of high certainty of a moderate benefit over an unspecified time period. Certainly, not a ringing endorsement.
While I think we must applaud the diligent efforts of the task force and its commitment to prevention, I fear that the strategy is too little too late. That being said, I am willing to accept the idea that targeting age 6 for intensive counseling may qualify for the better-late-than-never category. The task force acknowledges that procuring the resources given our already understaffed mental health clinics is going to be difficult and expensive. I would add that it will be so costly in time and money as to be unrealistic.
Based on my observations of thousands of children, the scaffolding of habits, diet, and preference for inactivity that underly obesity has already been laid by age 6. Are we prepared to shoulder our already overburdened school systems in an attempt to reconfigure this foundation of an obesogenic lifestyle? An effort on this scale after children have been sent off to first grade is doomed to failure.
A recent review of data reported by the CDC and reviewed in the journal Pediatrics reveals that about 2% of children receiving federal assistance from the WIC program are severely obese. It is probably safe to say that these preschoolers represent just the tip of a very concerning iceberg.
By waiting until age 6, we would increase the risk of further stigmatizing the obese child. What will he tell his peers when he is taken out of school or misses a playdate because he has to meet with his “obesity counselor”?
If we are going to take obesity prevention seriously and spend time and money in counseling, doesn’t it make more sense to invest this effort on the parents and the home situation when the child is still under their influence? We must be prepared to unwrap and employ an “intensive behavioral package” the first time we see evidence that the child’s growth chart is heading in an unhealthy direction.
This won’t always be easy. I can recall seeing a 4-year-old whose weight had risen dramatically from her previous curve in the year since her 3-year checkup. The answer became obvious when I discovered that her grandmother, for whom baking was a passion, had taken over as her daycare provider. Arriving at a solution that kept the family on speaking terms took some tact, but it was one of my rare successes in obesity prevention. And, it worked because of early intervention.
Thank you USPSTF, but 6 years is too late.
Dr. Wilkoff practiced primary care pediatrics in Brunswick, Maine, for nearly 40 years. He has authored several books on behavioral pediatrics, including “How to Say No to Your Toddler.” Other than a Littman stethoscope he accepted as a first-year medical student in 1966, Dr. Wilkoff reports having nothing to disclose. Email him at [email protected].
As we begin to find our way in the new world of obesity management, questions continue to surface more quickly than answers. This isn’t surprising, as we are being asked to view obesity as a disease when for decades the general consensus has been that overweight people are simply will power deficient.
Are the new drugs as effective as we are told by the patients and physicians who have had some experience using and prescribing them? Will they continue to be effective in the very long run? Will their safety record hold up over time? And for those of us in pediatrics, what will be their role for children? As a group we tend to be cautious about drugs that haven’t been thoroughly tested in children. How many years will it take before we feel comfortable with obesity drugs? And, of course, we should be asking ourselves the same questions about bariatric surgery.
Fortunately, while the media spotlight has been focused on the treatment arm of our obesity strategy, there are still some folks looking at what has been up to now the discouraging prospects for prevention. The U.S. Preventive Services Task Force (USPSTF) has recently released a draft of its recommendations that includes evidence supporting the effectiveness of “intensive behavioral interventions” (defined as a minimum of 26 hours of counseling). In reviewing data from nearly 60 randomized controlled trials, which included more than 10,000 children, the task force found that It should be noted that the USPSTF gave the intervention package only a B grade, which means that the agency found evidence of high certainty of a moderate benefit over an unspecified time period. Certainly, not a ringing endorsement.
While I think we must applaud the diligent efforts of the task force and its commitment to prevention, I fear that the strategy is too little too late. That being said, I am willing to accept the idea that targeting age 6 for intensive counseling may qualify for the better-late-than-never category. The task force acknowledges that procuring the resources given our already understaffed mental health clinics is going to be difficult and expensive. I would add that it will be so costly in time and money as to be unrealistic.
Based on my observations of thousands of children, the scaffolding of habits, diet, and preference for inactivity that underly obesity has already been laid by age 6. Are we prepared to shoulder our already overburdened school systems in an attempt to reconfigure this foundation of an obesogenic lifestyle? An effort on this scale after children have been sent off to first grade is doomed to failure.
A recent review of data reported by the CDC and reviewed in the journal Pediatrics reveals that about 2% of children receiving federal assistance from the WIC program are severely obese. It is probably safe to say that these preschoolers represent just the tip of a very concerning iceberg.
By waiting until age 6, we would increase the risk of further stigmatizing the obese child. What will he tell his peers when he is taken out of school or misses a playdate because he has to meet with his “obesity counselor”?
If we are going to take obesity prevention seriously and spend time and money in counseling, doesn’t it make more sense to invest this effort on the parents and the home situation when the child is still under their influence? We must be prepared to unwrap and employ an “intensive behavioral package” the first time we see evidence that the child’s growth chart is heading in an unhealthy direction.
This won’t always be easy. I can recall seeing a 4-year-old whose weight had risen dramatically from her previous curve in the year since her 3-year checkup. The answer became obvious when I discovered that her grandmother, for whom baking was a passion, had taken over as her daycare provider. Arriving at a solution that kept the family on speaking terms took some tact, but it was one of my rare successes in obesity prevention. And, it worked because of early intervention.
Thank you USPSTF, but 6 years is too late.
Dr. Wilkoff practiced primary care pediatrics in Brunswick, Maine, for nearly 40 years. He has authored several books on behavioral pediatrics, including “How to Say No to Your Toddler.” Other than a Littman stethoscope he accepted as a first-year medical student in 1966, Dr. Wilkoff reports having nothing to disclose. Email him at [email protected].
FDA Approves Topical Gel For Wounds Associated With JEB and DEB
The FDA has approved a topical gel containing birch triterpenes for the treatment of partial thickness wounds in patients 6 months and older with junctional epidermolysis bullosa (JEB) and dystrophic epidermolysis bullosa (DEB).
The gel is marketed under the name Filsuvez. It is the first approved treatment for wounds associated with JEB and the second for patients with DEB, following the approval of Vyjuvek (Krystal Biotech), a topical gene therapy gel, in May 2023.
First developed by Amryt Pharma and intended for home use, Filsuvez is now marketed by Chiesi Global Rare Diseases, which acquired Amryt in January 2023. The gel is applied topically to the wound at each dressing change.
The approval of Filsuvez is based on results from the Efficacy and Safety Study of Oleogel-S10 in Epidermolysis Bullosa (EASE), a randomized, placebo-controlled study of 223 people, the largest-ever phase 3 clinical trial for the treatment of EB, according to the Chiesi news release. The gel was well tolerated and met the primary endpoint with statistical significance, with 41.3% of patients achieving first complete target wound closure within 45 days (compared with 28.9% on placebo).
“I am so excited to say that this is another hurdle cleared and milestone achieved for the EB Community,” Brett Kopelan, executive director at debra of America said in a blog post. “We are now on the road to being able to treat EB more effectively, and to make the worst disease you’ve never heard of chronic, but livable, by making use of multiple therapeutic options in conjunction with each other.”
The FDA has approved a topical gel containing birch triterpenes for the treatment of partial thickness wounds in patients 6 months and older with junctional epidermolysis bullosa (JEB) and dystrophic epidermolysis bullosa (DEB).
The gel is marketed under the name Filsuvez. It is the first approved treatment for wounds associated with JEB and the second for patients with DEB, following the approval of Vyjuvek (Krystal Biotech), a topical gene therapy gel, in May 2023.
First developed by Amryt Pharma and intended for home use, Filsuvez is now marketed by Chiesi Global Rare Diseases, which acquired Amryt in January 2023. The gel is applied topically to the wound at each dressing change.
The approval of Filsuvez is based on results from the Efficacy and Safety Study of Oleogel-S10 in Epidermolysis Bullosa (EASE), a randomized, placebo-controlled study of 223 people, the largest-ever phase 3 clinical trial for the treatment of EB, according to the Chiesi news release. The gel was well tolerated and met the primary endpoint with statistical significance, with 41.3% of patients achieving first complete target wound closure within 45 days (compared with 28.9% on placebo).
“I am so excited to say that this is another hurdle cleared and milestone achieved for the EB Community,” Brett Kopelan, executive director at debra of America said in a blog post. “We are now on the road to being able to treat EB more effectively, and to make the worst disease you’ve never heard of chronic, but livable, by making use of multiple therapeutic options in conjunction with each other.”
The FDA has approved a topical gel containing birch triterpenes for the treatment of partial thickness wounds in patients 6 months and older with junctional epidermolysis bullosa (JEB) and dystrophic epidermolysis bullosa (DEB).
The gel is marketed under the name Filsuvez. It is the first approved treatment for wounds associated with JEB and the second for patients with DEB, following the approval of Vyjuvek (Krystal Biotech), a topical gene therapy gel, in May 2023.
First developed by Amryt Pharma and intended for home use, Filsuvez is now marketed by Chiesi Global Rare Diseases, which acquired Amryt in January 2023. The gel is applied topically to the wound at each dressing change.
The approval of Filsuvez is based on results from the Efficacy and Safety Study of Oleogel-S10 in Epidermolysis Bullosa (EASE), a randomized, placebo-controlled study of 223 people, the largest-ever phase 3 clinical trial for the treatment of EB, according to the Chiesi news release. The gel was well tolerated and met the primary endpoint with statistical significance, with 41.3% of patients achieving first complete target wound closure within 45 days (compared with 28.9% on placebo).
“I am so excited to say that this is another hurdle cleared and milestone achieved for the EB Community,” Brett Kopelan, executive director at debra of America said in a blog post. “We are now on the road to being able to treat EB more effectively, and to make the worst disease you’ve never heard of chronic, but livable, by making use of multiple therapeutic options in conjunction with each other.”
More Children Under Age 4 Have Severe Obesity: Study
Severe obesity among preschool-age children from low-income families is on the rise in the United States, according to a new analysis of federal data.
An estimated 2% of children ages 2 to 4 years old had severe obesity in 2020, up from 1.8% in 2016, according to the report that appeared Dec. 18 in Pediatrics, a journal published by the American Academy of Pediatrics.
The increase is “small but significant,” a group of experts not involved in the research wrote in a companion commentary published alongside the research.
The new data put an end to hopes that childhood obesity was on the retreat following a small decrease in rates from 2010 to 2016. Instead, the researchers noted that the new childhood obesity figures reflect those of the general population. In the United States, about 20% of children and teens are obese, and about 42% of adults are obese, according to the CDC.
This latest study looked for severe obesity, which was defined as being well above the 95th percentile for the combined height-weight measure known as body mass index. The figures are important because rates of severe obesity among young children can foreshadow health problems that may occur on a scale to warrant concerns among public health officials, policymakers, and health care professionals.
Compared with children who have moderate obesity, children with severe obesity “are at a greater risk of various health complications, including cardiovascular disease, metabolic syndrome, type 2 diabetes, fatty liver disease, and premature death,” the study authors wrote.
The largest increases from 2016 to 2020 in severe obesity were observed among 4-year-olds and among Hispanic children. When looking at state-level data, Alaska was the only state to report a decline in severe obesity among young children from 2016 to 2020.
The new estimates were drawn from data on children enrolled in the federal Special Supplemental Nutrition Program for Women, Infants, and Children (WIC).
“WIC is a federal assistance program that provides healthy foods, nutrition education, health care referrals, and other services to millions of low-income pregnant and postpartum women, as well as infants and children up to age 5, who are at nutritional risk,” the researchers noted.
The new figures indicate 16.6 million children ages 2 to 4 years old have severe obesity. Having severe obesity at these early ages is “nearly irreversible,” the authors of the commentary article noted, adding that little research exists that indicates how to effectively treat obesity before age 6.
“The study underscores the need for ongoing monitoring ... post pandemic of children’s health status,” a news release from the American Academy of Pediatrics stated. “It also further supports the need for children and families from households with lower incomes across the nation to have access to early clinical detection, such as health care screenings and referrals to effective family-based interventions to support healthy growth.”
A version of this article first appeared on WebMD.com.
Severe obesity among preschool-age children from low-income families is on the rise in the United States, according to a new analysis of federal data.
An estimated 2% of children ages 2 to 4 years old had severe obesity in 2020, up from 1.8% in 2016, according to the report that appeared Dec. 18 in Pediatrics, a journal published by the American Academy of Pediatrics.
The increase is “small but significant,” a group of experts not involved in the research wrote in a companion commentary published alongside the research.
The new data put an end to hopes that childhood obesity was on the retreat following a small decrease in rates from 2010 to 2016. Instead, the researchers noted that the new childhood obesity figures reflect those of the general population. In the United States, about 20% of children and teens are obese, and about 42% of adults are obese, according to the CDC.
This latest study looked for severe obesity, which was defined as being well above the 95th percentile for the combined height-weight measure known as body mass index. The figures are important because rates of severe obesity among young children can foreshadow health problems that may occur on a scale to warrant concerns among public health officials, policymakers, and health care professionals.
Compared with children who have moderate obesity, children with severe obesity “are at a greater risk of various health complications, including cardiovascular disease, metabolic syndrome, type 2 diabetes, fatty liver disease, and premature death,” the study authors wrote.
The largest increases from 2016 to 2020 in severe obesity were observed among 4-year-olds and among Hispanic children. When looking at state-level data, Alaska was the only state to report a decline in severe obesity among young children from 2016 to 2020.
The new estimates were drawn from data on children enrolled in the federal Special Supplemental Nutrition Program for Women, Infants, and Children (WIC).
“WIC is a federal assistance program that provides healthy foods, nutrition education, health care referrals, and other services to millions of low-income pregnant and postpartum women, as well as infants and children up to age 5, who are at nutritional risk,” the researchers noted.
The new figures indicate 16.6 million children ages 2 to 4 years old have severe obesity. Having severe obesity at these early ages is “nearly irreversible,” the authors of the commentary article noted, adding that little research exists that indicates how to effectively treat obesity before age 6.
“The study underscores the need for ongoing monitoring ... post pandemic of children’s health status,” a news release from the American Academy of Pediatrics stated. “It also further supports the need for children and families from households with lower incomes across the nation to have access to early clinical detection, such as health care screenings and referrals to effective family-based interventions to support healthy growth.”
A version of this article first appeared on WebMD.com.
Severe obesity among preschool-age children from low-income families is on the rise in the United States, according to a new analysis of federal data.
An estimated 2% of children ages 2 to 4 years old had severe obesity in 2020, up from 1.8% in 2016, according to the report that appeared Dec. 18 in Pediatrics, a journal published by the American Academy of Pediatrics.
The increase is “small but significant,” a group of experts not involved in the research wrote in a companion commentary published alongside the research.
The new data put an end to hopes that childhood obesity was on the retreat following a small decrease in rates from 2010 to 2016. Instead, the researchers noted that the new childhood obesity figures reflect those of the general population. In the United States, about 20% of children and teens are obese, and about 42% of adults are obese, according to the CDC.
This latest study looked for severe obesity, which was defined as being well above the 95th percentile for the combined height-weight measure known as body mass index. The figures are important because rates of severe obesity among young children can foreshadow health problems that may occur on a scale to warrant concerns among public health officials, policymakers, and health care professionals.
Compared with children who have moderate obesity, children with severe obesity “are at a greater risk of various health complications, including cardiovascular disease, metabolic syndrome, type 2 diabetes, fatty liver disease, and premature death,” the study authors wrote.
The largest increases from 2016 to 2020 in severe obesity were observed among 4-year-olds and among Hispanic children. When looking at state-level data, Alaska was the only state to report a decline in severe obesity among young children from 2016 to 2020.
The new estimates were drawn from data on children enrolled in the federal Special Supplemental Nutrition Program for Women, Infants, and Children (WIC).
“WIC is a federal assistance program that provides healthy foods, nutrition education, health care referrals, and other services to millions of low-income pregnant and postpartum women, as well as infants and children up to age 5, who are at nutritional risk,” the researchers noted.
The new figures indicate 16.6 million children ages 2 to 4 years old have severe obesity. Having severe obesity at these early ages is “nearly irreversible,” the authors of the commentary article noted, adding that little research exists that indicates how to effectively treat obesity before age 6.
“The study underscores the need for ongoing monitoring ... post pandemic of children’s health status,” a news release from the American Academy of Pediatrics stated. “It also further supports the need for children and families from households with lower incomes across the nation to have access to early clinical detection, such as health care screenings and referrals to effective family-based interventions to support healthy growth.”
A version of this article first appeared on WebMD.com.
Novel Solutions Needed to Attract Residents to Pediatric Rheumatology
Pediatric rheumatologists are calling a “Code (p)RED” — a pediatric rheumatology educational deficit.
There are too few pediatric rheumatologists to meet patient demand in the United States, and projections suggest that gap will continue to widen. Disappointing match trends also reflect issues with recruitment: Since 2019, only 50%-75% of pediatric rheumatology fellowship positions have been filled each year. For 2024, the subspecialty filled 32 of 52 positions.
Lack of exposure during medical school and residency, financial concerns, and a lengthy, research-focused fellowship are seen as major contributors to the workforce shortage, and novel solutions are needed to close the gap, experts argued in a recent presentation at the annual meeting of the American College of Rheumatology.
“It’s so important now to get ahead of this because what I’m afraid of is in 10-20 years, we’re not going to have a field,” Colleen Correll, MD, MPH, an associate professor in the division of pediatric rheumatology at the University of Minnesota Medical School in Minneapolis, told this news organization.
Growing Demand, Falling Supply
Because the subspecialty was officially recognized by the American Board of Pediatrics in 1991, “it’s always been a small group of providers,” Dr. Correll said. “It’s honestly always been a recognized issue in our field.”
But a 2022 report by the ACR on the pediatric workforce has brought more attention to the issue. Dr. Correll led the study and is the chair of ACR›s Pediatric Rheumatology Committee. According to the report, an estimated 287 pediatric rheumatologists were working as full-time clinicians in 2015, while the estimated demand was 382 providers. By 2030, this projected supply of pediatric rheumatologists fell to 261, while demand rose to 461 full-time providers.
The distribution of pediatric rheumatologists is also an issue. It’s generally thought that there should be at least one pediatric rheumatologist per 100,000 children, Dr. Correll explained. According to ACR estimates, the northeast region had approximately 0.83 pediatric rheumatologists per 100,000 in 2015, while the south central and southwest regions had 0.17 and 0.20 providers per 100,000 children, respectively. Projected estimates for 2030 dipped to 0.04 or lower for the south central, southwest, and southeast regions.
A separate study from the American Board of Pediatrics, also led by Dr. Correll, that is still under review offered more optimistic projections, suggesting that there would be a 75% increase in pediatric rheumatologists from 0.27 per 100,000 children in 2020 to 0.47 per 100,000 children in 2040.
“This does look better than the ACR study, though 0.47 is still a really small number and an inadequate number to treat our children in need,” she said during her presentation at the annual meeting of the American College of Rheumatology.
Lack of Exposure During Medical Education
Few medical schools have pediatric rheumatology built into their curriculum, whether that is a whole course or a single lecture, said Jay Mehta, MD, who directs the pediatric rheumatology fellowship at the Children’s Hospital of Philadelphia. Dr. Mehta, for example, did not know that pediatric rheumatology was a field before entering residency, he said. But residencies can also lack exposure: An estimated one third of residencies do not have a single pediatric rheumatologist on staff, he said.
“Those are places where people aren’t necessarily getting exposure to pediatric rheumatology,” he told this news organization, “and we know that if you’re not exposed to a field, it’s very, very unlikely that you will go into that field.”
The ACR’s Pediatric Rheumatology Residency Program is one way that the organization is working to address this issue. The program sends pediatric residents with an interest in rheumatology to the ACR annual meeting. The Rheumatology Research Foundation also runs a visiting professorship program, where a pediatric rheumatologist conducts a rheumatology education forum at an institution with no pediatric rheumatology program.
“I’ve done it a couple of times,” Dr. Mehta said during his presentation at the annual meeting. “It’s one of the most rewarding things I’ve done.”
Financial Concerns
Additionally, although pediatric rheumatology requires more training, these subspecialists will likely make less than their general pediatric colleagues over their career. According to one study in Pediatrics, a pediatric resident pursuing rheumatology is projected to make $1.2 million dollars less over the course of their career compared with someone who started their career in general pediatrics immediately after residency. (Negative financial returns were also found for all pediatric subspecialities except for cardiology, critical care, and neonatology.)
This lower earning potential is likely a deterrent, especially for those with educational debt. In one analysis published in October, medical students with at least $200,000 in education debt were 43% more likely to go into higher-paying pediatric subspecialities than those with no debt. Nearly three out of four medical graduates have education debt, according to the American Association of Medical Colleges, with a median debt of $200,000.
While the Pediatric Specialty Loan Repayment Program was specifically designed to aid pediatric subspecialists with their educational debt, qualifying for the program is difficult for pediatric rheumatologists, explained Kristen N. Hayward, MD, of Seattle Children’s in Washington. The program provides up to $100,000 in loan forgiveness in exchange for 3 years of practicing in an underserved area; however, the program stipulates that providers must provide full-time (40 hours per week) clinical care. At academic institutions, where most pediatric rheumatologists practice, there is usually a research component to their position, and even if a provider works the equivalent of 40 hours per week in a clinic in addition to their research, they don’t qualify for the program, Dr. Hayward said.
“It’s very difficult to find someone who’s actually only doing clinical work,” she said.
The ACR has worked to combat some of these economic constraints by demonstrating the direct and downstream value of rheumatologic care, Dr. Hayward said. In a recent white paper, it was estimated that including office visits, consultations, lab testing, and radiology services, one full-time equivalent rheumatologist generates $3.5 million in revenue every year and saves health systems more than $2700 per patient per year.
In addition to placing greater value on rheumatologic care, the healthcare system also needs to recognize the current nonbillable hours that pediatric rheumatologists spend taking care of patients, Dr. Hayward noted.
Especially with electronic medical records (EMRs) and online communication with patients, “there is increasingly a lot of patient care that happens outside of clinic and that takes a lot of time,” Dr. Hayward said. For example, she spends between 1 and 2 hours every day in the EMR refilling medications and responding to patient concerns, and “that all is done in my spare time,” she said. “That’s not billed to the patient in anyway.”
Length of Fellowship
The pediatric rheumatology fellowship is a 3-year program — like other pediatric subspecialities — with a research requirement. By comparison, adult rheumatology fellowships are 2 years, and fellows can pursue additional research training if they have a strong interest.
“It sounds like just 1 more year, but I think it’s coming at a really pivotal point in people’s lives, and that 1 year can make a huge difference,” Dr. Hayward explained.
The 2 years of research might also be a deterrent for individuals who know they are only interested in clinical work, she added. About half of pediatric subspecialists only pursue clinical work after graduation, according to a recent report by the National Academies of Sciences, Engineering, and Medicine (NASEM) focused on the future pediatric physician workforce.
Additionally, only 17% of pediatric rheumatologists spend more than half of their time in research, said Fred Rivara, MD, MPH, chair of the NASEM report, in a statement included in Dr. Hayward’s ACR presentation. The report, which recommended strategies to bolster the pediatric workforce, argued that the American Board of Pediatrics should develop alternative training pathways, including 2-year, clinically heavy fellowships.
The ACR workforce team is also exploring alternative training models like competency-based education, Dr. Hayward said. The Education in Pediatrics Across the Continuum project is already using this approach from medical school to pediatric residency. While this type of outcome-based program has not been tried at the fellowship level, «this has been done, it could be done, and I think we could learn from our colleagues about how they have done this successfully,» she noted.
Ultimately, Dr. Hayward emphasized that there needs to be a “sea change” to close the workforce gap — with multiple interventions addressing these individual challenges.
“Unless we all pitch in and find one way that we can all move this issue forward, we are going to be drowning in a sea of Epic inbox messages,” she said, “and never get to see the patients we want to see.”
Dr. Hayward previously owned stock/stock options for AbbVie/Abbott, Cigna/Express Scripts, Merck, and Teva and has received an educational grant from Pfizer. Dr. Correll and Dr. Mehta had no relevant disclosures.
A version of this article appeared on Medscape.com.
Pediatric rheumatologists are calling a “Code (p)RED” — a pediatric rheumatology educational deficit.
There are too few pediatric rheumatologists to meet patient demand in the United States, and projections suggest that gap will continue to widen. Disappointing match trends also reflect issues with recruitment: Since 2019, only 50%-75% of pediatric rheumatology fellowship positions have been filled each year. For 2024, the subspecialty filled 32 of 52 positions.
Lack of exposure during medical school and residency, financial concerns, and a lengthy, research-focused fellowship are seen as major contributors to the workforce shortage, and novel solutions are needed to close the gap, experts argued in a recent presentation at the annual meeting of the American College of Rheumatology.
“It’s so important now to get ahead of this because what I’m afraid of is in 10-20 years, we’re not going to have a field,” Colleen Correll, MD, MPH, an associate professor in the division of pediatric rheumatology at the University of Minnesota Medical School in Minneapolis, told this news organization.
Growing Demand, Falling Supply
Because the subspecialty was officially recognized by the American Board of Pediatrics in 1991, “it’s always been a small group of providers,” Dr. Correll said. “It’s honestly always been a recognized issue in our field.”
But a 2022 report by the ACR on the pediatric workforce has brought more attention to the issue. Dr. Correll led the study and is the chair of ACR›s Pediatric Rheumatology Committee. According to the report, an estimated 287 pediatric rheumatologists were working as full-time clinicians in 2015, while the estimated demand was 382 providers. By 2030, this projected supply of pediatric rheumatologists fell to 261, while demand rose to 461 full-time providers.
The distribution of pediatric rheumatologists is also an issue. It’s generally thought that there should be at least one pediatric rheumatologist per 100,000 children, Dr. Correll explained. According to ACR estimates, the northeast region had approximately 0.83 pediatric rheumatologists per 100,000 in 2015, while the south central and southwest regions had 0.17 and 0.20 providers per 100,000 children, respectively. Projected estimates for 2030 dipped to 0.04 or lower for the south central, southwest, and southeast regions.
A separate study from the American Board of Pediatrics, also led by Dr. Correll, that is still under review offered more optimistic projections, suggesting that there would be a 75% increase in pediatric rheumatologists from 0.27 per 100,000 children in 2020 to 0.47 per 100,000 children in 2040.
“This does look better than the ACR study, though 0.47 is still a really small number and an inadequate number to treat our children in need,” she said during her presentation at the annual meeting of the American College of Rheumatology.
Lack of Exposure During Medical Education
Few medical schools have pediatric rheumatology built into their curriculum, whether that is a whole course or a single lecture, said Jay Mehta, MD, who directs the pediatric rheumatology fellowship at the Children’s Hospital of Philadelphia. Dr. Mehta, for example, did not know that pediatric rheumatology was a field before entering residency, he said. But residencies can also lack exposure: An estimated one third of residencies do not have a single pediatric rheumatologist on staff, he said.
“Those are places where people aren’t necessarily getting exposure to pediatric rheumatology,” he told this news organization, “and we know that if you’re not exposed to a field, it’s very, very unlikely that you will go into that field.”
The ACR’s Pediatric Rheumatology Residency Program is one way that the organization is working to address this issue. The program sends pediatric residents with an interest in rheumatology to the ACR annual meeting. The Rheumatology Research Foundation also runs a visiting professorship program, where a pediatric rheumatologist conducts a rheumatology education forum at an institution with no pediatric rheumatology program.
“I’ve done it a couple of times,” Dr. Mehta said during his presentation at the annual meeting. “It’s one of the most rewarding things I’ve done.”
Financial Concerns
Additionally, although pediatric rheumatology requires more training, these subspecialists will likely make less than their general pediatric colleagues over their career. According to one study in Pediatrics, a pediatric resident pursuing rheumatology is projected to make $1.2 million dollars less over the course of their career compared with someone who started their career in general pediatrics immediately after residency. (Negative financial returns were also found for all pediatric subspecialities except for cardiology, critical care, and neonatology.)
This lower earning potential is likely a deterrent, especially for those with educational debt. In one analysis published in October, medical students with at least $200,000 in education debt were 43% more likely to go into higher-paying pediatric subspecialities than those with no debt. Nearly three out of four medical graduates have education debt, according to the American Association of Medical Colleges, with a median debt of $200,000.
While the Pediatric Specialty Loan Repayment Program was specifically designed to aid pediatric subspecialists with their educational debt, qualifying for the program is difficult for pediatric rheumatologists, explained Kristen N. Hayward, MD, of Seattle Children’s in Washington. The program provides up to $100,000 in loan forgiveness in exchange for 3 years of practicing in an underserved area; however, the program stipulates that providers must provide full-time (40 hours per week) clinical care. At academic institutions, where most pediatric rheumatologists practice, there is usually a research component to their position, and even if a provider works the equivalent of 40 hours per week in a clinic in addition to their research, they don’t qualify for the program, Dr. Hayward said.
“It’s very difficult to find someone who’s actually only doing clinical work,” she said.
The ACR has worked to combat some of these economic constraints by demonstrating the direct and downstream value of rheumatologic care, Dr. Hayward said. In a recent white paper, it was estimated that including office visits, consultations, lab testing, and radiology services, one full-time equivalent rheumatologist generates $3.5 million in revenue every year and saves health systems more than $2700 per patient per year.
In addition to placing greater value on rheumatologic care, the healthcare system also needs to recognize the current nonbillable hours that pediatric rheumatologists spend taking care of patients, Dr. Hayward noted.
Especially with electronic medical records (EMRs) and online communication with patients, “there is increasingly a lot of patient care that happens outside of clinic and that takes a lot of time,” Dr. Hayward said. For example, she spends between 1 and 2 hours every day in the EMR refilling medications and responding to patient concerns, and “that all is done in my spare time,” she said. “That’s not billed to the patient in anyway.”
Length of Fellowship
The pediatric rheumatology fellowship is a 3-year program — like other pediatric subspecialities — with a research requirement. By comparison, adult rheumatology fellowships are 2 years, and fellows can pursue additional research training if they have a strong interest.
“It sounds like just 1 more year, but I think it’s coming at a really pivotal point in people’s lives, and that 1 year can make a huge difference,” Dr. Hayward explained.
The 2 years of research might also be a deterrent for individuals who know they are only interested in clinical work, she added. About half of pediatric subspecialists only pursue clinical work after graduation, according to a recent report by the National Academies of Sciences, Engineering, and Medicine (NASEM) focused on the future pediatric physician workforce.
Additionally, only 17% of pediatric rheumatologists spend more than half of their time in research, said Fred Rivara, MD, MPH, chair of the NASEM report, in a statement included in Dr. Hayward’s ACR presentation. The report, which recommended strategies to bolster the pediatric workforce, argued that the American Board of Pediatrics should develop alternative training pathways, including 2-year, clinically heavy fellowships.
The ACR workforce team is also exploring alternative training models like competency-based education, Dr. Hayward said. The Education in Pediatrics Across the Continuum project is already using this approach from medical school to pediatric residency. While this type of outcome-based program has not been tried at the fellowship level, «this has been done, it could be done, and I think we could learn from our colleagues about how they have done this successfully,» she noted.
Ultimately, Dr. Hayward emphasized that there needs to be a “sea change” to close the workforce gap — with multiple interventions addressing these individual challenges.
“Unless we all pitch in and find one way that we can all move this issue forward, we are going to be drowning in a sea of Epic inbox messages,” she said, “and never get to see the patients we want to see.”
Dr. Hayward previously owned stock/stock options for AbbVie/Abbott, Cigna/Express Scripts, Merck, and Teva and has received an educational grant from Pfizer. Dr. Correll and Dr. Mehta had no relevant disclosures.
A version of this article appeared on Medscape.com.
Pediatric rheumatologists are calling a “Code (p)RED” — a pediatric rheumatology educational deficit.
There are too few pediatric rheumatologists to meet patient demand in the United States, and projections suggest that gap will continue to widen. Disappointing match trends also reflect issues with recruitment: Since 2019, only 50%-75% of pediatric rheumatology fellowship positions have been filled each year. For 2024, the subspecialty filled 32 of 52 positions.
Lack of exposure during medical school and residency, financial concerns, and a lengthy, research-focused fellowship are seen as major contributors to the workforce shortage, and novel solutions are needed to close the gap, experts argued in a recent presentation at the annual meeting of the American College of Rheumatology.
“It’s so important now to get ahead of this because what I’m afraid of is in 10-20 years, we’re not going to have a field,” Colleen Correll, MD, MPH, an associate professor in the division of pediatric rheumatology at the University of Minnesota Medical School in Minneapolis, told this news organization.
Growing Demand, Falling Supply
Because the subspecialty was officially recognized by the American Board of Pediatrics in 1991, “it’s always been a small group of providers,” Dr. Correll said. “It’s honestly always been a recognized issue in our field.”
But a 2022 report by the ACR on the pediatric workforce has brought more attention to the issue. Dr. Correll led the study and is the chair of ACR›s Pediatric Rheumatology Committee. According to the report, an estimated 287 pediatric rheumatologists were working as full-time clinicians in 2015, while the estimated demand was 382 providers. By 2030, this projected supply of pediatric rheumatologists fell to 261, while demand rose to 461 full-time providers.
The distribution of pediatric rheumatologists is also an issue. It’s generally thought that there should be at least one pediatric rheumatologist per 100,000 children, Dr. Correll explained. According to ACR estimates, the northeast region had approximately 0.83 pediatric rheumatologists per 100,000 in 2015, while the south central and southwest regions had 0.17 and 0.20 providers per 100,000 children, respectively. Projected estimates for 2030 dipped to 0.04 or lower for the south central, southwest, and southeast regions.
A separate study from the American Board of Pediatrics, also led by Dr. Correll, that is still under review offered more optimistic projections, suggesting that there would be a 75% increase in pediatric rheumatologists from 0.27 per 100,000 children in 2020 to 0.47 per 100,000 children in 2040.
“This does look better than the ACR study, though 0.47 is still a really small number and an inadequate number to treat our children in need,” she said during her presentation at the annual meeting of the American College of Rheumatology.
Lack of Exposure During Medical Education
Few medical schools have pediatric rheumatology built into their curriculum, whether that is a whole course or a single lecture, said Jay Mehta, MD, who directs the pediatric rheumatology fellowship at the Children’s Hospital of Philadelphia. Dr. Mehta, for example, did not know that pediatric rheumatology was a field before entering residency, he said. But residencies can also lack exposure: An estimated one third of residencies do not have a single pediatric rheumatologist on staff, he said.
“Those are places where people aren’t necessarily getting exposure to pediatric rheumatology,” he told this news organization, “and we know that if you’re not exposed to a field, it’s very, very unlikely that you will go into that field.”
The ACR’s Pediatric Rheumatology Residency Program is one way that the organization is working to address this issue. The program sends pediatric residents with an interest in rheumatology to the ACR annual meeting. The Rheumatology Research Foundation also runs a visiting professorship program, where a pediatric rheumatologist conducts a rheumatology education forum at an institution with no pediatric rheumatology program.
“I’ve done it a couple of times,” Dr. Mehta said during his presentation at the annual meeting. “It’s one of the most rewarding things I’ve done.”
Financial Concerns
Additionally, although pediatric rheumatology requires more training, these subspecialists will likely make less than their general pediatric colleagues over their career. According to one study in Pediatrics, a pediatric resident pursuing rheumatology is projected to make $1.2 million dollars less over the course of their career compared with someone who started their career in general pediatrics immediately after residency. (Negative financial returns were also found for all pediatric subspecialities except for cardiology, critical care, and neonatology.)
This lower earning potential is likely a deterrent, especially for those with educational debt. In one analysis published in October, medical students with at least $200,000 in education debt were 43% more likely to go into higher-paying pediatric subspecialities than those with no debt. Nearly three out of four medical graduates have education debt, according to the American Association of Medical Colleges, with a median debt of $200,000.
While the Pediatric Specialty Loan Repayment Program was specifically designed to aid pediatric subspecialists with their educational debt, qualifying for the program is difficult for pediatric rheumatologists, explained Kristen N. Hayward, MD, of Seattle Children’s in Washington. The program provides up to $100,000 in loan forgiveness in exchange for 3 years of practicing in an underserved area; however, the program stipulates that providers must provide full-time (40 hours per week) clinical care. At academic institutions, where most pediatric rheumatologists practice, there is usually a research component to their position, and even if a provider works the equivalent of 40 hours per week in a clinic in addition to their research, they don’t qualify for the program, Dr. Hayward said.
“It’s very difficult to find someone who’s actually only doing clinical work,” she said.
The ACR has worked to combat some of these economic constraints by demonstrating the direct and downstream value of rheumatologic care, Dr. Hayward said. In a recent white paper, it was estimated that including office visits, consultations, lab testing, and radiology services, one full-time equivalent rheumatologist generates $3.5 million in revenue every year and saves health systems more than $2700 per patient per year.
In addition to placing greater value on rheumatologic care, the healthcare system also needs to recognize the current nonbillable hours that pediatric rheumatologists spend taking care of patients, Dr. Hayward noted.
Especially with electronic medical records (EMRs) and online communication with patients, “there is increasingly a lot of patient care that happens outside of clinic and that takes a lot of time,” Dr. Hayward said. For example, she spends between 1 and 2 hours every day in the EMR refilling medications and responding to patient concerns, and “that all is done in my spare time,” she said. “That’s not billed to the patient in anyway.”
Length of Fellowship
The pediatric rheumatology fellowship is a 3-year program — like other pediatric subspecialities — with a research requirement. By comparison, adult rheumatology fellowships are 2 years, and fellows can pursue additional research training if they have a strong interest.
“It sounds like just 1 more year, but I think it’s coming at a really pivotal point in people’s lives, and that 1 year can make a huge difference,” Dr. Hayward explained.
The 2 years of research might also be a deterrent for individuals who know they are only interested in clinical work, she added. About half of pediatric subspecialists only pursue clinical work after graduation, according to a recent report by the National Academies of Sciences, Engineering, and Medicine (NASEM) focused on the future pediatric physician workforce.
Additionally, only 17% of pediatric rheumatologists spend more than half of their time in research, said Fred Rivara, MD, MPH, chair of the NASEM report, in a statement included in Dr. Hayward’s ACR presentation. The report, which recommended strategies to bolster the pediatric workforce, argued that the American Board of Pediatrics should develop alternative training pathways, including 2-year, clinically heavy fellowships.
The ACR workforce team is also exploring alternative training models like competency-based education, Dr. Hayward said. The Education in Pediatrics Across the Continuum project is already using this approach from medical school to pediatric residency. While this type of outcome-based program has not been tried at the fellowship level, «this has been done, it could be done, and I think we could learn from our colleagues about how they have done this successfully,» she noted.
Ultimately, Dr. Hayward emphasized that there needs to be a “sea change” to close the workforce gap — with multiple interventions addressing these individual challenges.
“Unless we all pitch in and find one way that we can all move this issue forward, we are going to be drowning in a sea of Epic inbox messages,” she said, “and never get to see the patients we want to see.”
Dr. Hayward previously owned stock/stock options for AbbVie/Abbott, Cigna/Express Scripts, Merck, and Teva and has received an educational grant from Pfizer. Dr. Correll and Dr. Mehta had no relevant disclosures.
A version of this article appeared on Medscape.com.
FROM ACR 2023
Roflumilast foam gets nod as new option for seborrheic dermatitis
The in a press release.
The 0.3% foam, marketed as Zoryve, applied once-daily, is indicated for patients aged 9 years and older with seborrheic dermatitis, and can be used anywhere on the body, including areas with hair, with no limits on duration of use, according to the company, Arcutis. A 0.3% cream formulation of roflumilast was previously approved by the FDA for the topical treatment of plaque psoriasis in patients aged 6 years and older.
Approval was based on data from the phase 3 STRATUM trial and an accompanying phase 2 study known as Trial 203. These studies included a total of 683 adults and youth aged 9 years and older with seborrheic dermatitis. Participants were randomized to roflumilast or a placebo.
At 8 weeks, 79.5 % of patients on roflumilast met the primary efficacy endpoint of Investigator Global Assessment (IGA) scores of 0 or 1 (clear or almost clear) compared with 58.0% of patients on placebo (P < .001); the results were similar in the phase 2 Trial 203 (73.1% vs. 40.8%, respectively; P < .001). Overall, more than 50% of the patients on roflumilast achieved a clear score.
Patients in the roflumilast group also showed significant improvement in all secondary endpoints, including itching, scaling, and erythema, according to the company.
In the STRATUM study, 62.8% of roflumilast-treated patients and 40.6% of placebo patients achieved a 4-point or more reduction in itch based on the Worst Itch Numerical Rating Score (P =.0001), and 28% of roflumilast-treated patients reported significant itch improvement within the first 48 hours of use, compared with 13% of placebo patients (P = .0024).
Over a treatment period of up to 1 year, no treatment-related severe adverse events were reported in the phase 2 and 3 studies. The incidence of treatment emergent adverse events was similar between the treatment and placebo groups, and the most common adverse events (occurring in 1% of more of patients) across both studies were nasopharyngitis (1.5%), nausea (1.3%), and headache (1.1%).
Roflumilast foam is scheduled to be available by the end of January 2024, according to the company. The product is for topical use only, and contraindicated for individuals with severe liver impairment.
The in a press release.
The 0.3% foam, marketed as Zoryve, applied once-daily, is indicated for patients aged 9 years and older with seborrheic dermatitis, and can be used anywhere on the body, including areas with hair, with no limits on duration of use, according to the company, Arcutis. A 0.3% cream formulation of roflumilast was previously approved by the FDA for the topical treatment of plaque psoriasis in patients aged 6 years and older.
Approval was based on data from the phase 3 STRATUM trial and an accompanying phase 2 study known as Trial 203. These studies included a total of 683 adults and youth aged 9 years and older with seborrheic dermatitis. Participants were randomized to roflumilast or a placebo.
At 8 weeks, 79.5 % of patients on roflumilast met the primary efficacy endpoint of Investigator Global Assessment (IGA) scores of 0 or 1 (clear or almost clear) compared with 58.0% of patients on placebo (P < .001); the results were similar in the phase 2 Trial 203 (73.1% vs. 40.8%, respectively; P < .001). Overall, more than 50% of the patients on roflumilast achieved a clear score.
Patients in the roflumilast group also showed significant improvement in all secondary endpoints, including itching, scaling, and erythema, according to the company.
In the STRATUM study, 62.8% of roflumilast-treated patients and 40.6% of placebo patients achieved a 4-point or more reduction in itch based on the Worst Itch Numerical Rating Score (P =.0001), and 28% of roflumilast-treated patients reported significant itch improvement within the first 48 hours of use, compared with 13% of placebo patients (P = .0024).
Over a treatment period of up to 1 year, no treatment-related severe adverse events were reported in the phase 2 and 3 studies. The incidence of treatment emergent adverse events was similar between the treatment and placebo groups, and the most common adverse events (occurring in 1% of more of patients) across both studies were nasopharyngitis (1.5%), nausea (1.3%), and headache (1.1%).
Roflumilast foam is scheduled to be available by the end of January 2024, according to the company. The product is for topical use only, and contraindicated for individuals with severe liver impairment.
The in a press release.
The 0.3% foam, marketed as Zoryve, applied once-daily, is indicated for patients aged 9 years and older with seborrheic dermatitis, and can be used anywhere on the body, including areas with hair, with no limits on duration of use, according to the company, Arcutis. A 0.3% cream formulation of roflumilast was previously approved by the FDA for the topical treatment of plaque psoriasis in patients aged 6 years and older.
Approval was based on data from the phase 3 STRATUM trial and an accompanying phase 2 study known as Trial 203. These studies included a total of 683 adults and youth aged 9 years and older with seborrheic dermatitis. Participants were randomized to roflumilast or a placebo.
At 8 weeks, 79.5 % of patients on roflumilast met the primary efficacy endpoint of Investigator Global Assessment (IGA) scores of 0 or 1 (clear or almost clear) compared with 58.0% of patients on placebo (P < .001); the results were similar in the phase 2 Trial 203 (73.1% vs. 40.8%, respectively; P < .001). Overall, more than 50% of the patients on roflumilast achieved a clear score.
Patients in the roflumilast group also showed significant improvement in all secondary endpoints, including itching, scaling, and erythema, according to the company.
In the STRATUM study, 62.8% of roflumilast-treated patients and 40.6% of placebo patients achieved a 4-point or more reduction in itch based on the Worst Itch Numerical Rating Score (P =.0001), and 28% of roflumilast-treated patients reported significant itch improvement within the first 48 hours of use, compared with 13% of placebo patients (P = .0024).
Over a treatment period of up to 1 year, no treatment-related severe adverse events were reported in the phase 2 and 3 studies. The incidence of treatment emergent adverse events was similar between the treatment and placebo groups, and the most common adverse events (occurring in 1% of more of patients) across both studies were nasopharyngitis (1.5%), nausea (1.3%), and headache (1.1%).
Roflumilast foam is scheduled to be available by the end of January 2024, according to the company. The product is for topical use only, and contraindicated for individuals with severe liver impairment.
Sometimes well-intended mental health treatment hurts
We love psychiatry. We love the idea that someone can come to receive care from a physician to alleviate psychological suffering.
Some people experience such severe anguish that they are unable to relate to others. Some are so despondent that they are unable to make decisions. Some are so distressed that their thoughts become inconsistent with reality. We want all those people, and many more, to have access to effective psychiatric care. However, there are reasonable expectations that one should be able to have that a treatment will help, and that appropriate informed consent is given.
One recent article reminded us of this in a particularly poignant way.
The study in question is a recent publication looking at the universal use of psychotherapy for teenagers.1 At face value, we would have certainly considered this to be a benevolent and well-meaning intervention. Anyone who has been a teenager or has talked to one, is aware of the emotional instability punctuated by episodes of intense anxiety or irritability. It is age appropriate for a teenager to question and explore their identity. Teenagers are notoriously impulsive with a deep desire for validating interpersonal relationships. One could continue to list the symptoms of borderline personality disorder (BPD) and find a lot of similarity with the condition of transitioning from a child to an adult.
It is thus common sense to consider applying the most established therapy for BPD, dialectical behavioral therapy (DBT), to teenagers. The basics of DBT would seem to be helpful to anyone but appear particularly appropriate to this population. Mindfulness, the practice of paying attention to your present experience, allows one to realize that they are trapped in past or hypothetical future moments. Emotional regulation provides the tools that offer a frame for our feelings and involves recognizing feelings and understanding what they mean. Interpersonal work allows one to recognize and adapt to the feelings of others, while learning how to have a healthy voice with others. Distress tolerance is the exercise of learning to experience and contain our feelings.
The study looked at about 1,000 young adolescents, around 13 years old across high schools in Sydney, Australia: 598 adolescents were allocated to the intervention, and 566 to the control. The intervention consisted of eight weekly sessions of DBT lasting about 50 minutes. The results were “contrary to predictions.” Participants who received DBT “reported significantly increased total difficulties,” and “significant increases in depression and anxiety.” The effects were worse in males yet significant in both genders. The study concludes with “a reminder that present enthusiasm for universal dissemination of short-term DBT-based group skills training within schools, specifically in early adolescence, is ahead of the research evidence.”
We can’t help but wonder why the outcomes of the study were this way; here are some ideas:
• Society has natural ways of developing interpersonal skills, emotional regulation, and the ability to appreciate the present. Interpersonal skills are consistently fostered and tested in schools. Navigating high school parties, the process of organizing them, and getting invited to them requires significant social dexterity. Rejection from romantic interest, alienation from peers, rewards for accomplishment, and acceptance by other peers are some of the daily emotional obstacles that teenagers face. Being constantly taught by older individuals and scolded by parents is its own course in mindfulness. Those are few of the many natural processes of interpersonal growth that formalized therapy may impede.
• The universal discussion of psychological terms and psychiatric symptoms may not only destigmatize mental illness, but also normalize and possibly even promote it. While punishing or stigmatizing a child for having mental illness is obviously unacceptable and cruel, we do wonder if the compulsory psychotherapy may provide negative effects. Psychotherapies, especially manualized ones, were developed to alleviate mental suffering. It seems possible that this format normalizes pathology.
In 1961, Erving Goffman described the concept of sane people appearing insane in an asylum as “mortification.” In 2023, we have much improved, but have we done something to internalize patterns of suffering and alienation rather than dispel them? They are given forms that explain what the feeling of depression is when they may have never considered it. They are given tools to handle distress, when distress may not be present.
• Many human beings live on a fairly tight rope of suppression and the less adaptive repression. Suppression is the defense mechanism by which individuals make an effort to put distressing thoughts out of conscious awareness. After a difficult breakup a teenager may ask some friends to go out and watch a movie, making efforts to put negative feelings out of conscious awareness until there is an opportunity to cope adaptively with those stressors.
Repression is the defense mechanism by which individuals make an effort to prevent distressing thoughts from entering conscious awareness in the first place. After a difficult breakup a teenager acts like nothing happened. While not particularly adaptive, many people live with significant repression and without particular anguish. It is possible that uncovering all of those repressed and suppressed feelings through the exploratory work of therapy may destabilize individuals from their tight rope.
• A less problematic explanation could also be what was previously referred to as therapeutic regression. In psychoanalytic theory, patients are generally thought to have a compromise formation, a psychological strategy used to reconcile conflicting drives. The compromise formation is the way a patient balances their desires against moral expectations and the realities of the external world. In therapy, that compromise formation can be challenged, leading to therapeutic regression.
By uncovering and confronting deeply rooted feelings, a patient may find that their symptoms temporarily intensify. This may not be a problem, but a necessary step to growth in some patients. It is possible that a program longer than 8 weeks would have overcome a temporary worsening in outcome measures.
While it’s easy to highlight the darker moments in psychiatric history, psychiatry has grown into a field which offers well-accepted and uncontroversially promoted forms of treatment. This is evolution, exemplified by the mere consideration of the universal use of psychotherapy for teenagers. But this raises important questions about the potential unintended consequences of normalizing and formalizing therapy. It prompted us to reflect on whether psychiatric treatment is always the best solution and if it might, at times, impede natural processes of growth and coping.
In this context, the study on universal DBT-based group skills training for teenagers challenged our assumptions. The unexpected outcomes suggest that societal and educational systems may naturally foster many of the skills that formalized therapy seeks to provide, and may do so with greater efficacy than that which prescriptive psychiatric treatments have to offer. Moreover, the universal discussion of psychiatric symptoms may not only destigmatize mental illness but also normalize it, potentially leading to unnecessary pathology.
Finally, the study prompted us to consider the fine balance that people find themselves in, questioning whether we should be so certain that our interventions can always provide a better outcome than an individual’s current coping mechanisms. These findings serve as a valuable reminder that our enthusiasm for widespread psychiatric interventions should be tempered by rigorous research and a nuanced understanding of human psychology and development.
This study could be an example of the grandiose stance psychiatry has at times taken of late, suggesting the field has an intervention for all that ails you and can serve as a corrective to society’s maladaptive deviations. Rising rates of mental illness in the community are not interpreted as a failing of the field of psychiatry, but as evidence that we need more psychiatrists. Acts of gun violence, ever increasing rates suicides, and even political disagreements are met with the idea that if only we had more mental health capacity, this could be avoided.
Dr. Badre is a clinical and forensic psychiatrist in San Diego. He holds teaching positions at the University of California, San Diego, and the University of San Diego. He teaches medical education, psychopharmacology, ethics in psychiatry, and correctional care. Dr. Badre can be reached at his website, BadreMD.com. He has no conflicts of interest. Dr. ZoBell is a fourth-year senior resident at UCSD Psychiatry Residency Program. She is currently serving as the program’s Chief Resident at the VA San Diego on the inpatient psychiatric unit. Dr. ZoBell is interested in outpatient and emergency psychiatry as well as psychotherapy. Dr. Lehman is a professor of psychiatry at the University of California, San Diego. He is codirector of all acute and intensive psychiatric treatment at the Veterans Affairs Medical Center in San Diego, where he practices clinical psychiatry. He has no conflicts of interest.
Reference
1. Harvey, LJ, et al. Investigating the efficacy of a Dialectical behaviour therapy-based universal intervention on adolescent social and emotional well-being outcomes. Behav Res Ther. 2023 Oct. doi: 10.1016/j.brat.2023.104408.
We love psychiatry. We love the idea that someone can come to receive care from a physician to alleviate psychological suffering.
Some people experience such severe anguish that they are unable to relate to others. Some are so despondent that they are unable to make decisions. Some are so distressed that their thoughts become inconsistent with reality. We want all those people, and many more, to have access to effective psychiatric care. However, there are reasonable expectations that one should be able to have that a treatment will help, and that appropriate informed consent is given.
One recent article reminded us of this in a particularly poignant way.
The study in question is a recent publication looking at the universal use of psychotherapy for teenagers.1 At face value, we would have certainly considered this to be a benevolent and well-meaning intervention. Anyone who has been a teenager or has talked to one, is aware of the emotional instability punctuated by episodes of intense anxiety or irritability. It is age appropriate for a teenager to question and explore their identity. Teenagers are notoriously impulsive with a deep desire for validating interpersonal relationships. One could continue to list the symptoms of borderline personality disorder (BPD) and find a lot of similarity with the condition of transitioning from a child to an adult.
It is thus common sense to consider applying the most established therapy for BPD, dialectical behavioral therapy (DBT), to teenagers. The basics of DBT would seem to be helpful to anyone but appear particularly appropriate to this population. Mindfulness, the practice of paying attention to your present experience, allows one to realize that they are trapped in past or hypothetical future moments. Emotional regulation provides the tools that offer a frame for our feelings and involves recognizing feelings and understanding what they mean. Interpersonal work allows one to recognize and adapt to the feelings of others, while learning how to have a healthy voice with others. Distress tolerance is the exercise of learning to experience and contain our feelings.
The study looked at about 1,000 young adolescents, around 13 years old across high schools in Sydney, Australia: 598 adolescents were allocated to the intervention, and 566 to the control. The intervention consisted of eight weekly sessions of DBT lasting about 50 minutes. The results were “contrary to predictions.” Participants who received DBT “reported significantly increased total difficulties,” and “significant increases in depression and anxiety.” The effects were worse in males yet significant in both genders. The study concludes with “a reminder that present enthusiasm for universal dissemination of short-term DBT-based group skills training within schools, specifically in early adolescence, is ahead of the research evidence.”
We can’t help but wonder why the outcomes of the study were this way; here are some ideas:
• Society has natural ways of developing interpersonal skills, emotional regulation, and the ability to appreciate the present. Interpersonal skills are consistently fostered and tested in schools. Navigating high school parties, the process of organizing them, and getting invited to them requires significant social dexterity. Rejection from romantic interest, alienation from peers, rewards for accomplishment, and acceptance by other peers are some of the daily emotional obstacles that teenagers face. Being constantly taught by older individuals and scolded by parents is its own course in mindfulness. Those are few of the many natural processes of interpersonal growth that formalized therapy may impede.
• The universal discussion of psychological terms and psychiatric symptoms may not only destigmatize mental illness, but also normalize and possibly even promote it. While punishing or stigmatizing a child for having mental illness is obviously unacceptable and cruel, we do wonder if the compulsory psychotherapy may provide negative effects. Psychotherapies, especially manualized ones, were developed to alleviate mental suffering. It seems possible that this format normalizes pathology.
In 1961, Erving Goffman described the concept of sane people appearing insane in an asylum as “mortification.” In 2023, we have much improved, but have we done something to internalize patterns of suffering and alienation rather than dispel them? They are given forms that explain what the feeling of depression is when they may have never considered it. They are given tools to handle distress, when distress may not be present.
• Many human beings live on a fairly tight rope of suppression and the less adaptive repression. Suppression is the defense mechanism by which individuals make an effort to put distressing thoughts out of conscious awareness. After a difficult breakup a teenager may ask some friends to go out and watch a movie, making efforts to put negative feelings out of conscious awareness until there is an opportunity to cope adaptively with those stressors.
Repression is the defense mechanism by which individuals make an effort to prevent distressing thoughts from entering conscious awareness in the first place. After a difficult breakup a teenager acts like nothing happened. While not particularly adaptive, many people live with significant repression and without particular anguish. It is possible that uncovering all of those repressed and suppressed feelings through the exploratory work of therapy may destabilize individuals from their tight rope.
• A less problematic explanation could also be what was previously referred to as therapeutic regression. In psychoanalytic theory, patients are generally thought to have a compromise formation, a psychological strategy used to reconcile conflicting drives. The compromise formation is the way a patient balances their desires against moral expectations and the realities of the external world. In therapy, that compromise formation can be challenged, leading to therapeutic regression.
By uncovering and confronting deeply rooted feelings, a patient may find that their symptoms temporarily intensify. This may not be a problem, but a necessary step to growth in some patients. It is possible that a program longer than 8 weeks would have overcome a temporary worsening in outcome measures.
While it’s easy to highlight the darker moments in psychiatric history, psychiatry has grown into a field which offers well-accepted and uncontroversially promoted forms of treatment. This is evolution, exemplified by the mere consideration of the universal use of psychotherapy for teenagers. But this raises important questions about the potential unintended consequences of normalizing and formalizing therapy. It prompted us to reflect on whether psychiatric treatment is always the best solution and if it might, at times, impede natural processes of growth and coping.
In this context, the study on universal DBT-based group skills training for teenagers challenged our assumptions. The unexpected outcomes suggest that societal and educational systems may naturally foster many of the skills that formalized therapy seeks to provide, and may do so with greater efficacy than that which prescriptive psychiatric treatments have to offer. Moreover, the universal discussion of psychiatric symptoms may not only destigmatize mental illness but also normalize it, potentially leading to unnecessary pathology.
Finally, the study prompted us to consider the fine balance that people find themselves in, questioning whether we should be so certain that our interventions can always provide a better outcome than an individual’s current coping mechanisms. These findings serve as a valuable reminder that our enthusiasm for widespread psychiatric interventions should be tempered by rigorous research and a nuanced understanding of human psychology and development.
This study could be an example of the grandiose stance psychiatry has at times taken of late, suggesting the field has an intervention for all that ails you and can serve as a corrective to society’s maladaptive deviations. Rising rates of mental illness in the community are not interpreted as a failing of the field of psychiatry, but as evidence that we need more psychiatrists. Acts of gun violence, ever increasing rates suicides, and even political disagreements are met with the idea that if only we had more mental health capacity, this could be avoided.
Dr. Badre is a clinical and forensic psychiatrist in San Diego. He holds teaching positions at the University of California, San Diego, and the University of San Diego. He teaches medical education, psychopharmacology, ethics in psychiatry, and correctional care. Dr. Badre can be reached at his website, BadreMD.com. He has no conflicts of interest. Dr. ZoBell is a fourth-year senior resident at UCSD Psychiatry Residency Program. She is currently serving as the program’s Chief Resident at the VA San Diego on the inpatient psychiatric unit. Dr. ZoBell is interested in outpatient and emergency psychiatry as well as psychotherapy. Dr. Lehman is a professor of psychiatry at the University of California, San Diego. He is codirector of all acute and intensive psychiatric treatment at the Veterans Affairs Medical Center in San Diego, where he practices clinical psychiatry. He has no conflicts of interest.
Reference
1. Harvey, LJ, et al. Investigating the efficacy of a Dialectical behaviour therapy-based universal intervention on adolescent social and emotional well-being outcomes. Behav Res Ther. 2023 Oct. doi: 10.1016/j.brat.2023.104408.
We love psychiatry. We love the idea that someone can come to receive care from a physician to alleviate psychological suffering.
Some people experience such severe anguish that they are unable to relate to others. Some are so despondent that they are unable to make decisions. Some are so distressed that their thoughts become inconsistent with reality. We want all those people, and many more, to have access to effective psychiatric care. However, there are reasonable expectations that one should be able to have that a treatment will help, and that appropriate informed consent is given.
One recent article reminded us of this in a particularly poignant way.
The study in question is a recent publication looking at the universal use of psychotherapy for teenagers.1 At face value, we would have certainly considered this to be a benevolent and well-meaning intervention. Anyone who has been a teenager or has talked to one, is aware of the emotional instability punctuated by episodes of intense anxiety or irritability. It is age appropriate for a teenager to question and explore their identity. Teenagers are notoriously impulsive with a deep desire for validating interpersonal relationships. One could continue to list the symptoms of borderline personality disorder (BPD) and find a lot of similarity with the condition of transitioning from a child to an adult.
It is thus common sense to consider applying the most established therapy for BPD, dialectical behavioral therapy (DBT), to teenagers. The basics of DBT would seem to be helpful to anyone but appear particularly appropriate to this population. Mindfulness, the practice of paying attention to your present experience, allows one to realize that they are trapped in past or hypothetical future moments. Emotional regulation provides the tools that offer a frame for our feelings and involves recognizing feelings and understanding what they mean. Interpersonal work allows one to recognize and adapt to the feelings of others, while learning how to have a healthy voice with others. Distress tolerance is the exercise of learning to experience and contain our feelings.
The study looked at about 1,000 young adolescents, around 13 years old across high schools in Sydney, Australia: 598 adolescents were allocated to the intervention, and 566 to the control. The intervention consisted of eight weekly sessions of DBT lasting about 50 minutes. The results were “contrary to predictions.” Participants who received DBT “reported significantly increased total difficulties,” and “significant increases in depression and anxiety.” The effects were worse in males yet significant in both genders. The study concludes with “a reminder that present enthusiasm for universal dissemination of short-term DBT-based group skills training within schools, specifically in early adolescence, is ahead of the research evidence.”
We can’t help but wonder why the outcomes of the study were this way; here are some ideas:
• Society has natural ways of developing interpersonal skills, emotional regulation, and the ability to appreciate the present. Interpersonal skills are consistently fostered and tested in schools. Navigating high school parties, the process of organizing them, and getting invited to them requires significant social dexterity. Rejection from romantic interest, alienation from peers, rewards for accomplishment, and acceptance by other peers are some of the daily emotional obstacles that teenagers face. Being constantly taught by older individuals and scolded by parents is its own course in mindfulness. Those are few of the many natural processes of interpersonal growth that formalized therapy may impede.
• The universal discussion of psychological terms and psychiatric symptoms may not only destigmatize mental illness, but also normalize and possibly even promote it. While punishing or stigmatizing a child for having mental illness is obviously unacceptable and cruel, we do wonder if the compulsory psychotherapy may provide negative effects. Psychotherapies, especially manualized ones, were developed to alleviate mental suffering. It seems possible that this format normalizes pathology.
In 1961, Erving Goffman described the concept of sane people appearing insane in an asylum as “mortification.” In 2023, we have much improved, but have we done something to internalize patterns of suffering and alienation rather than dispel them? They are given forms that explain what the feeling of depression is when they may have never considered it. They are given tools to handle distress, when distress may not be present.
• Many human beings live on a fairly tight rope of suppression and the less adaptive repression. Suppression is the defense mechanism by which individuals make an effort to put distressing thoughts out of conscious awareness. After a difficult breakup a teenager may ask some friends to go out and watch a movie, making efforts to put negative feelings out of conscious awareness until there is an opportunity to cope adaptively with those stressors.
Repression is the defense mechanism by which individuals make an effort to prevent distressing thoughts from entering conscious awareness in the first place. After a difficult breakup a teenager acts like nothing happened. While not particularly adaptive, many people live with significant repression and without particular anguish. It is possible that uncovering all of those repressed and suppressed feelings through the exploratory work of therapy may destabilize individuals from their tight rope.
• A less problematic explanation could also be what was previously referred to as therapeutic regression. In psychoanalytic theory, patients are generally thought to have a compromise formation, a psychological strategy used to reconcile conflicting drives. The compromise formation is the way a patient balances their desires against moral expectations and the realities of the external world. In therapy, that compromise formation can be challenged, leading to therapeutic regression.
By uncovering and confronting deeply rooted feelings, a patient may find that their symptoms temporarily intensify. This may not be a problem, but a necessary step to growth in some patients. It is possible that a program longer than 8 weeks would have overcome a temporary worsening in outcome measures.
While it’s easy to highlight the darker moments in psychiatric history, psychiatry has grown into a field which offers well-accepted and uncontroversially promoted forms of treatment. This is evolution, exemplified by the mere consideration of the universal use of psychotherapy for teenagers. But this raises important questions about the potential unintended consequences of normalizing and formalizing therapy. It prompted us to reflect on whether psychiatric treatment is always the best solution and if it might, at times, impede natural processes of growth and coping.
In this context, the study on universal DBT-based group skills training for teenagers challenged our assumptions. The unexpected outcomes suggest that societal and educational systems may naturally foster many of the skills that formalized therapy seeks to provide, and may do so with greater efficacy than that which prescriptive psychiatric treatments have to offer. Moreover, the universal discussion of psychiatric symptoms may not only destigmatize mental illness but also normalize it, potentially leading to unnecessary pathology.
Finally, the study prompted us to consider the fine balance that people find themselves in, questioning whether we should be so certain that our interventions can always provide a better outcome than an individual’s current coping mechanisms. These findings serve as a valuable reminder that our enthusiasm for widespread psychiatric interventions should be tempered by rigorous research and a nuanced understanding of human psychology and development.
This study could be an example of the grandiose stance psychiatry has at times taken of late, suggesting the field has an intervention for all that ails you and can serve as a corrective to society’s maladaptive deviations. Rising rates of mental illness in the community are not interpreted as a failing of the field of psychiatry, but as evidence that we need more psychiatrists. Acts of gun violence, ever increasing rates suicides, and even political disagreements are met with the idea that if only we had more mental health capacity, this could be avoided.
Dr. Badre is a clinical and forensic psychiatrist in San Diego. He holds teaching positions at the University of California, San Diego, and the University of San Diego. He teaches medical education, psychopharmacology, ethics in psychiatry, and correctional care. Dr. Badre can be reached at his website, BadreMD.com. He has no conflicts of interest. Dr. ZoBell is a fourth-year senior resident at UCSD Psychiatry Residency Program. She is currently serving as the program’s Chief Resident at the VA San Diego on the inpatient psychiatric unit. Dr. ZoBell is interested in outpatient and emergency psychiatry as well as psychotherapy. Dr. Lehman is a professor of psychiatry at the University of California, San Diego. He is codirector of all acute and intensive psychiatric treatment at the Veterans Affairs Medical Center in San Diego, where he practices clinical psychiatry. He has no conflicts of interest.
Reference
1. Harvey, LJ, et al. Investigating the efficacy of a Dialectical behaviour therapy-based universal intervention on adolescent social and emotional well-being outcomes. Behav Res Ther. 2023 Oct. doi: 10.1016/j.brat.2023.104408.
How does lebrikizumab perform across different racial and ethnic subgroups?
.
The finding comes from an analysis of the 16-week induction periods of the phase 3 ADvocate1 and ADvocate2 trials, which Raj Chovatiya, MD, PhD, presented during a late-breaking abstract session at the Revolutionizing Atopic Dermatitis (RAD) Virtual Conference. The efficacy of lebrikizumab monotherapy to treat moderate-to-severe AD has been established in phase 3 studies, “but disease characteristic and efficacy outcomes may vary among racial and ethnic subgroups,” said Dr. Chovatiya, assistant professor in the department of dermatology at Northwestern University, Chicago. “The goal of the current study is to report the week 16 efficacy of lebrikizumab-treated patients in racial and ethnic subgroups from ADvocate1 and ADvocate2.”
Key eligibility criteria for both trials included adults or adolescents with a diagnosis of AD as defined by the American Academy of Dermatology Consensus Criteria, for at least 1 year prior to screening. They had moderate-to-severe AD, were candidates for systemic therapy, and were dupilumab- and tralokinumab-naive. Outcomes of interest were the Investigator’s Global Assessment 0 or 1, with at least a 2-point improvement; and the proportions of patients who achieved Eczema Area and Severity Index (EASI75) and EASI90 responses, and an improvement of 4 points or more on the Pruritus Numeric Rating Scale (NRS).
For statistical analysis, the researchers pooled data from Advocate1 and Advocate2 and applied imputation methodology to the 16-week induction period. Subsequent data from patients who received topical or systemic rescue medication or discontinued treatment due to lack of efficacy were imputed as nonresponders. Subsequent data from patients who discontinued treatment for other reasons were set to missing, and the researchers handled missing data with multiple imputation. They used logistic regression to test the interaction between the treatment and subgroup and the Cochran-Mantel-Haenszel method to evaluate the treatment effect within each subgroup after adjusting for stratification factors.
Dr. Chovatiya reported findings from the 851 study participants in the combined studies. Of these, 542 were White, 192 were Asian, 84 were Black, and 33 were from other racial subgroups. By ethnic subgroup, 748 were not Hispanic or Latino, 91 were Hispanic or Latino, and ethnicity was unknown or not reported for 12 subjects. At baseline, the mean body mass index was slightly higher among Blacks (30.4 kg/m2) and Hispanics (29.4 kg/m2) compared with other racial and ethnic groups, “which reflects general epidemiologic data among these groups in the United States,” Dr. Chovatiya said. “You can also see a difference in the balance of IGA scores — they were a little bit more severe in the Black or African American and Hispanic groups as well.” The researchers also observed differences in the baseline EASI score across some of these groups, particularly in the Asian individuals, who had higher EASI scores. Prior use of systemic therapy was lower in the Black and “other” subgroups, compared with other racial subgroups.
At week 16, key efficacy endpoints were generally similar between the different racial subgroups. Specifically, 25.1% of Asians in the lebrikizumab treatment group achieved an IGA of 0/1, compared with 4.1% of those in the placebo group (P < .001), while 33.2% of Blacks in the lebrikizumab treatment group achieved an IGA of 0/1, compared with 13.2% of those in the placebo group (no P value was established because this subgroup represented less than 10% of the entire study population). In addition, 43.3% of Whites in the lebrikizumab treatment group achieved an IGA of 0/1, compared with 14.1% of those in the placebo group (P < .001).
In other findings, 45.5% of Asians in the lebrikizumab treatment group achieved an EASI75, compared with 8.5% of those in the placebo group (P < .001), while 51.7% of Blacks in the lebrikizumab treatment group achieved an EASI75, compared with 18.8% of those in the placebo group. Among whites in the lebrikizumab treatment group, 59.7% of achieved an EASI75, compared with 20.4% of those in the placebo group (P < .001).
Dr. Chovatiya said that 26.5% of Asians in the lebrikizumab treatment group achieved an EASI90, compared with 4.3% of those in the placebo group (P < .001), while 26.9% of Blacks in the lebrikizumab treatment group achieved an EASI90, compared with 13.2% of those in the placebo group. In addition, 38.3% of Whites in the lebrikizumab treatment group achieved an EASI90, compared with 10.9% of those in the placebo group (P < .001).
Finally, 36.4% of Asians in the lebrikizumab treatment group achieved a 4-point or greater improvement on the NRS, compared with 5.7% of those in the placebo group (P <. 001), while 41.7% of Blacks in the lebrikizumab treatment group achieved a 4-point or greater improvement on the NRS, compared with 17.4% of those in the placebo group. In addition, 45.9% of Whites in the lebrikizumab treatment group achieved a 4-point or greater improvement on the NRS, compared with 14.8% of those in the placebo group (P < .001). Statistical analyses of efficacy endpoints conducted by ethnic group yielded similar results.
Dr. Chovatiya acknowledged certain limitations of the study, including the fact that differences in baseline demographics and disease characteristics limit direct comparison across racial and ethnic subgroups. “Due to the relatively small sample size of some racial and ethnic subgroups and the post hoc nature of this analysis, additional studies are needed to verify these results,” he concluded. But for now, he said, the data available indicate that “lebrikizumab is effective across racial and ethnic subgroups for the treatment of moderate-to-severe AD after 16 weeks of monotherapy treatment.”
The study was funded by Dermira, a wholly owned subsidiary of Eli Lilly and Company. Dr. Chovatiya disclosed that he is speaker for and/or a consult and advisory board member to many pharmaceutical companies, including Eli Lilly.
.
The finding comes from an analysis of the 16-week induction periods of the phase 3 ADvocate1 and ADvocate2 trials, which Raj Chovatiya, MD, PhD, presented during a late-breaking abstract session at the Revolutionizing Atopic Dermatitis (RAD) Virtual Conference. The efficacy of lebrikizumab monotherapy to treat moderate-to-severe AD has been established in phase 3 studies, “but disease characteristic and efficacy outcomes may vary among racial and ethnic subgroups,” said Dr. Chovatiya, assistant professor in the department of dermatology at Northwestern University, Chicago. “The goal of the current study is to report the week 16 efficacy of lebrikizumab-treated patients in racial and ethnic subgroups from ADvocate1 and ADvocate2.”
Key eligibility criteria for both trials included adults or adolescents with a diagnosis of AD as defined by the American Academy of Dermatology Consensus Criteria, for at least 1 year prior to screening. They had moderate-to-severe AD, were candidates for systemic therapy, and were dupilumab- and tralokinumab-naive. Outcomes of interest were the Investigator’s Global Assessment 0 or 1, with at least a 2-point improvement; and the proportions of patients who achieved Eczema Area and Severity Index (EASI75) and EASI90 responses, and an improvement of 4 points or more on the Pruritus Numeric Rating Scale (NRS).
For statistical analysis, the researchers pooled data from Advocate1 and Advocate2 and applied imputation methodology to the 16-week induction period. Subsequent data from patients who received topical or systemic rescue medication or discontinued treatment due to lack of efficacy were imputed as nonresponders. Subsequent data from patients who discontinued treatment for other reasons were set to missing, and the researchers handled missing data with multiple imputation. They used logistic regression to test the interaction between the treatment and subgroup and the Cochran-Mantel-Haenszel method to evaluate the treatment effect within each subgroup after adjusting for stratification factors.
Dr. Chovatiya reported findings from the 851 study participants in the combined studies. Of these, 542 were White, 192 were Asian, 84 were Black, and 33 were from other racial subgroups. By ethnic subgroup, 748 were not Hispanic or Latino, 91 were Hispanic or Latino, and ethnicity was unknown or not reported for 12 subjects. At baseline, the mean body mass index was slightly higher among Blacks (30.4 kg/m2) and Hispanics (29.4 kg/m2) compared with other racial and ethnic groups, “which reflects general epidemiologic data among these groups in the United States,” Dr. Chovatiya said. “You can also see a difference in the balance of IGA scores — they were a little bit more severe in the Black or African American and Hispanic groups as well.” The researchers also observed differences in the baseline EASI score across some of these groups, particularly in the Asian individuals, who had higher EASI scores. Prior use of systemic therapy was lower in the Black and “other” subgroups, compared with other racial subgroups.
At week 16, key efficacy endpoints were generally similar between the different racial subgroups. Specifically, 25.1% of Asians in the lebrikizumab treatment group achieved an IGA of 0/1, compared with 4.1% of those in the placebo group (P < .001), while 33.2% of Blacks in the lebrikizumab treatment group achieved an IGA of 0/1, compared with 13.2% of those in the placebo group (no P value was established because this subgroup represented less than 10% of the entire study population). In addition, 43.3% of Whites in the lebrikizumab treatment group achieved an IGA of 0/1, compared with 14.1% of those in the placebo group (P < .001).
In other findings, 45.5% of Asians in the lebrikizumab treatment group achieved an EASI75, compared with 8.5% of those in the placebo group (P < .001), while 51.7% of Blacks in the lebrikizumab treatment group achieved an EASI75, compared with 18.8% of those in the placebo group. Among whites in the lebrikizumab treatment group, 59.7% of achieved an EASI75, compared with 20.4% of those in the placebo group (P < .001).
Dr. Chovatiya said that 26.5% of Asians in the lebrikizumab treatment group achieved an EASI90, compared with 4.3% of those in the placebo group (P < .001), while 26.9% of Blacks in the lebrikizumab treatment group achieved an EASI90, compared with 13.2% of those in the placebo group. In addition, 38.3% of Whites in the lebrikizumab treatment group achieved an EASI90, compared with 10.9% of those in the placebo group (P < .001).
Finally, 36.4% of Asians in the lebrikizumab treatment group achieved a 4-point or greater improvement on the NRS, compared with 5.7% of those in the placebo group (P <. 001), while 41.7% of Blacks in the lebrikizumab treatment group achieved a 4-point or greater improvement on the NRS, compared with 17.4% of those in the placebo group. In addition, 45.9% of Whites in the lebrikizumab treatment group achieved a 4-point or greater improvement on the NRS, compared with 14.8% of those in the placebo group (P < .001). Statistical analyses of efficacy endpoints conducted by ethnic group yielded similar results.
Dr. Chovatiya acknowledged certain limitations of the study, including the fact that differences in baseline demographics and disease characteristics limit direct comparison across racial and ethnic subgroups. “Due to the relatively small sample size of some racial and ethnic subgroups and the post hoc nature of this analysis, additional studies are needed to verify these results,” he concluded. But for now, he said, the data available indicate that “lebrikizumab is effective across racial and ethnic subgroups for the treatment of moderate-to-severe AD after 16 weeks of monotherapy treatment.”
The study was funded by Dermira, a wholly owned subsidiary of Eli Lilly and Company. Dr. Chovatiya disclosed that he is speaker for and/or a consult and advisory board member to many pharmaceutical companies, including Eli Lilly.
.
The finding comes from an analysis of the 16-week induction periods of the phase 3 ADvocate1 and ADvocate2 trials, which Raj Chovatiya, MD, PhD, presented during a late-breaking abstract session at the Revolutionizing Atopic Dermatitis (RAD) Virtual Conference. The efficacy of lebrikizumab monotherapy to treat moderate-to-severe AD has been established in phase 3 studies, “but disease characteristic and efficacy outcomes may vary among racial and ethnic subgroups,” said Dr. Chovatiya, assistant professor in the department of dermatology at Northwestern University, Chicago. “The goal of the current study is to report the week 16 efficacy of lebrikizumab-treated patients in racial and ethnic subgroups from ADvocate1 and ADvocate2.”
Key eligibility criteria for both trials included adults or adolescents with a diagnosis of AD as defined by the American Academy of Dermatology Consensus Criteria, for at least 1 year prior to screening. They had moderate-to-severe AD, were candidates for systemic therapy, and were dupilumab- and tralokinumab-naive. Outcomes of interest were the Investigator’s Global Assessment 0 or 1, with at least a 2-point improvement; and the proportions of patients who achieved Eczema Area and Severity Index (EASI75) and EASI90 responses, and an improvement of 4 points or more on the Pruritus Numeric Rating Scale (NRS).
For statistical analysis, the researchers pooled data from Advocate1 and Advocate2 and applied imputation methodology to the 16-week induction period. Subsequent data from patients who received topical or systemic rescue medication or discontinued treatment due to lack of efficacy were imputed as nonresponders. Subsequent data from patients who discontinued treatment for other reasons were set to missing, and the researchers handled missing data with multiple imputation. They used logistic regression to test the interaction between the treatment and subgroup and the Cochran-Mantel-Haenszel method to evaluate the treatment effect within each subgroup after adjusting for stratification factors.
Dr. Chovatiya reported findings from the 851 study participants in the combined studies. Of these, 542 were White, 192 were Asian, 84 were Black, and 33 were from other racial subgroups. By ethnic subgroup, 748 were not Hispanic or Latino, 91 were Hispanic or Latino, and ethnicity was unknown or not reported for 12 subjects. At baseline, the mean body mass index was slightly higher among Blacks (30.4 kg/m2) and Hispanics (29.4 kg/m2) compared with other racial and ethnic groups, “which reflects general epidemiologic data among these groups in the United States,” Dr. Chovatiya said. “You can also see a difference in the balance of IGA scores — they were a little bit more severe in the Black or African American and Hispanic groups as well.” The researchers also observed differences in the baseline EASI score across some of these groups, particularly in the Asian individuals, who had higher EASI scores. Prior use of systemic therapy was lower in the Black and “other” subgroups, compared with other racial subgroups.
At week 16, key efficacy endpoints were generally similar between the different racial subgroups. Specifically, 25.1% of Asians in the lebrikizumab treatment group achieved an IGA of 0/1, compared with 4.1% of those in the placebo group (P < .001), while 33.2% of Blacks in the lebrikizumab treatment group achieved an IGA of 0/1, compared with 13.2% of those in the placebo group (no P value was established because this subgroup represented less than 10% of the entire study population). In addition, 43.3% of Whites in the lebrikizumab treatment group achieved an IGA of 0/1, compared with 14.1% of those in the placebo group (P < .001).
In other findings, 45.5% of Asians in the lebrikizumab treatment group achieved an EASI75, compared with 8.5% of those in the placebo group (P < .001), while 51.7% of Blacks in the lebrikizumab treatment group achieved an EASI75, compared with 18.8% of those in the placebo group. Among whites in the lebrikizumab treatment group, 59.7% of achieved an EASI75, compared with 20.4% of those in the placebo group (P < .001).
Dr. Chovatiya said that 26.5% of Asians in the lebrikizumab treatment group achieved an EASI90, compared with 4.3% of those in the placebo group (P < .001), while 26.9% of Blacks in the lebrikizumab treatment group achieved an EASI90, compared with 13.2% of those in the placebo group. In addition, 38.3% of Whites in the lebrikizumab treatment group achieved an EASI90, compared with 10.9% of those in the placebo group (P < .001).
Finally, 36.4% of Asians in the lebrikizumab treatment group achieved a 4-point or greater improvement on the NRS, compared with 5.7% of those in the placebo group (P <. 001), while 41.7% of Blacks in the lebrikizumab treatment group achieved a 4-point or greater improvement on the NRS, compared with 17.4% of those in the placebo group. In addition, 45.9% of Whites in the lebrikizumab treatment group achieved a 4-point or greater improvement on the NRS, compared with 14.8% of those in the placebo group (P < .001). Statistical analyses of efficacy endpoints conducted by ethnic group yielded similar results.
Dr. Chovatiya acknowledged certain limitations of the study, including the fact that differences in baseline demographics and disease characteristics limit direct comparison across racial and ethnic subgroups. “Due to the relatively small sample size of some racial and ethnic subgroups and the post hoc nature of this analysis, additional studies are needed to verify these results,” he concluded. But for now, he said, the data available indicate that “lebrikizumab is effective across racial and ethnic subgroups for the treatment of moderate-to-severe AD after 16 weeks of monotherapy treatment.”
The study was funded by Dermira, a wholly owned subsidiary of Eli Lilly and Company. Dr. Chovatiya disclosed that he is speaker for and/or a consult and advisory board member to many pharmaceutical companies, including Eli Lilly.
FROM RAD 2023
Neighborhood Disadvantage Tied to Higher Risk for ASD
TOPLINE
, a population-based prospective cohort study shows.
METHODOLOGY
- Investigators analyzed data from a large cohort of singleton children with insurance born in Kaiser Permanente Southern California hospitals between 2001 and 2014.
- They ascertained ASD diagnosis, maternal race and ethnicity, and maternal address at time of birth.
- Neighborhood disadvantage was determined by the percentage of families in the mother’s neighborhood considered to be living in poverty, unemployed, have female-headed households with children, using public assistance, less than a high school education, among other variables.
TAKEAWAY
- Among 318,300 mothers who delivered babies during the study period, 6350 children were diagnosed with ASD during follow-up, and median age at diagnosis was 3.5 years.
- Greater neighborhood disadvantage at birth was associated with a higher likelihood of ASD diagnosis (adjusted hazard ratio [aHR], 1.07; 95% CI, 1.02-1.11)
- ASD diagnoses were more likely among children of mothers who were Black (aHR, 1.13; 95% CI, 1.02-1.25), Asian/Pacific Islander (aHR, 1.11; 95% CI, 1.02-1.20), or Hispanic (aHR, 1.07; 95% CI, 1.00-1.15), even after the researchers controlled for neighborhood.
- While odds of an ASD diagnosis were higher among children from minority racial and ethnic groups, neighborhood disadvantage was significantly associated with ASD diagnosis only for children of White mothers (aHR, 1.17; 95% CI, 1.09-1.26).
IN PRACTICE
Investigators noted that they could only speculate about the factors driving the association between neighborhood disadvantage and a stronger risk for ASD diagnosis in children of White mothers. “They may be due to systemic racism, discrimination, and their impact on maternal health during pregnancy,” they wrote.
SOURCE
Xin Yu, MS, and Daniel Hackman, PhD, of the University of Southern California Los Angeles, led the study, which was published online November 15 in JAMA Psychiatry.
LIMITATIONS
The research was limited by a lack of information on fathers and variables such as incomes, which may have confounded the findings. The authors also acknowledged that the study should be replicated in other health service settings.
DISCLOSURES
The study was funded by the National Institutes on Environmental Health Sciences, the National Institutes of Health (NIH), and the Environmental Protection Agency. Dr. Hackman reported receiving grant funding from NIH during the conduct of the study. Other disclosures are available in the original study.
A version of this article appeared on Medscape.com.
TOPLINE
, a population-based prospective cohort study shows.
METHODOLOGY
- Investigators analyzed data from a large cohort of singleton children with insurance born in Kaiser Permanente Southern California hospitals between 2001 and 2014.
- They ascertained ASD diagnosis, maternal race and ethnicity, and maternal address at time of birth.
- Neighborhood disadvantage was determined by the percentage of families in the mother’s neighborhood considered to be living in poverty, unemployed, have female-headed households with children, using public assistance, less than a high school education, among other variables.
TAKEAWAY
- Among 318,300 mothers who delivered babies during the study period, 6350 children were diagnosed with ASD during follow-up, and median age at diagnosis was 3.5 years.
- Greater neighborhood disadvantage at birth was associated with a higher likelihood of ASD diagnosis (adjusted hazard ratio [aHR], 1.07; 95% CI, 1.02-1.11)
- ASD diagnoses were more likely among children of mothers who were Black (aHR, 1.13; 95% CI, 1.02-1.25), Asian/Pacific Islander (aHR, 1.11; 95% CI, 1.02-1.20), or Hispanic (aHR, 1.07; 95% CI, 1.00-1.15), even after the researchers controlled for neighborhood.
- While odds of an ASD diagnosis were higher among children from minority racial and ethnic groups, neighborhood disadvantage was significantly associated with ASD diagnosis only for children of White mothers (aHR, 1.17; 95% CI, 1.09-1.26).
IN PRACTICE
Investigators noted that they could only speculate about the factors driving the association between neighborhood disadvantage and a stronger risk for ASD diagnosis in children of White mothers. “They may be due to systemic racism, discrimination, and their impact on maternal health during pregnancy,” they wrote.
SOURCE
Xin Yu, MS, and Daniel Hackman, PhD, of the University of Southern California Los Angeles, led the study, which was published online November 15 in JAMA Psychiatry.
LIMITATIONS
The research was limited by a lack of information on fathers and variables such as incomes, which may have confounded the findings. The authors also acknowledged that the study should be replicated in other health service settings.
DISCLOSURES
The study was funded by the National Institutes on Environmental Health Sciences, the National Institutes of Health (NIH), and the Environmental Protection Agency. Dr. Hackman reported receiving grant funding from NIH during the conduct of the study. Other disclosures are available in the original study.
A version of this article appeared on Medscape.com.
TOPLINE
, a population-based prospective cohort study shows.
METHODOLOGY
- Investigators analyzed data from a large cohort of singleton children with insurance born in Kaiser Permanente Southern California hospitals between 2001 and 2014.
- They ascertained ASD diagnosis, maternal race and ethnicity, and maternal address at time of birth.
- Neighborhood disadvantage was determined by the percentage of families in the mother’s neighborhood considered to be living in poverty, unemployed, have female-headed households with children, using public assistance, less than a high school education, among other variables.
TAKEAWAY
- Among 318,300 mothers who delivered babies during the study period, 6350 children were diagnosed with ASD during follow-up, and median age at diagnosis was 3.5 years.
- Greater neighborhood disadvantage at birth was associated with a higher likelihood of ASD diagnosis (adjusted hazard ratio [aHR], 1.07; 95% CI, 1.02-1.11)
- ASD diagnoses were more likely among children of mothers who were Black (aHR, 1.13; 95% CI, 1.02-1.25), Asian/Pacific Islander (aHR, 1.11; 95% CI, 1.02-1.20), or Hispanic (aHR, 1.07; 95% CI, 1.00-1.15), even after the researchers controlled for neighborhood.
- While odds of an ASD diagnosis were higher among children from minority racial and ethnic groups, neighborhood disadvantage was significantly associated with ASD diagnosis only for children of White mothers (aHR, 1.17; 95% CI, 1.09-1.26).
IN PRACTICE
Investigators noted that they could only speculate about the factors driving the association between neighborhood disadvantage and a stronger risk for ASD diagnosis in children of White mothers. “They may be due to systemic racism, discrimination, and their impact on maternal health during pregnancy,” they wrote.
SOURCE
Xin Yu, MS, and Daniel Hackman, PhD, of the University of Southern California Los Angeles, led the study, which was published online November 15 in JAMA Psychiatry.
LIMITATIONS
The research was limited by a lack of information on fathers and variables such as incomes, which may have confounded the findings. The authors also acknowledged that the study should be replicated in other health service settings.
DISCLOSURES
The study was funded by the National Institutes on Environmental Health Sciences, the National Institutes of Health (NIH), and the Environmental Protection Agency. Dr. Hackman reported receiving grant funding from NIH during the conduct of the study. Other disclosures are available in the original study.
A version of this article appeared on Medscape.com.