Pediatrics

STOCKHOLM – Early adolescence may be a period of heightened susceptibility to future development of multiple sclerosis (MS) resulting from exposure to pneumonia and other forms of lung inflammation, Scott Montgomery, PhD, said at the annual congress of the European Committee for Treatment and Research in Multiple Sclerosis.

This is speculative, he readily acknowledged, but it is a hypothesis supported by multiple lines of evidence provided by separate Swedish national health care registry studies he has led that showed associations between pneumonia or infectious mononucleosis occurring in early adolescence and increased risk of later MS.

These findings are consistent with the well-established observations that two other causes of lung irritation – cigarette smoking and exposure to organic solvents – are also linked to increased risk of MS (Neurology. 2018 Jul 31;91[5]:e455-62), noted Dr. Montgomery, head of the clinical epidemiology research group at Örebro (Sweden) University.

Moreover, he and his coinvestigators also found in yet another Swedish national registry cohort study that one concussion during adolescence was independently associated with a statistically significant 1.22-fold increased risk of later MS, while two or more were linked to a 2.33-fold increased risk. In contrast, concussions occurring before age 11 years were not associated with any increased risk of MS, which suggests an age-defined period of susceptibility (Ann Neurol. 2017 Oct;82[4]:554-61).

“There seems to be greater brain resilience in childhood as compared to adolescence,” Dr. Montgomery commented.

The new Swedish registry pneumonia study included 6,109 Swedish MS patients and 49,479 controls matched for age, gender, and locale. In an analysis adjusted for education level and history of infectious mononucleosis, history of having pneumonia at age 11-15 years was independently associated with a 2.8-fold increased risk of subsequent MS. Pneumonia occurring at age 16-20 years was associated with a more modest 1.38-fold increased risk, which did not achieve statistical significance, while pneumonia up to age 5 years or at age 6-10 years conferred no increased risk. The investigators restricted their analysis to cases of pneumonia occurring up to age 20 years because that is younger than the typical age of MS onset. The age restriction sidestepped the potential for confounding by reverse causation since it is known that pneumonia occurs with increased frequency in patients with MS.

Because MS patients also have an increased risk of urinary tract infections, Dr. Montgomery and coinvestigators also analyzed the same pediatric data set for UTI rates broken down by 5-year age groups. Rates were similar in individuals who later developed MS and in controls, which suggests that the observed increase in MS risk associated with pneumonia in early adolescence was not an expression of an MS prodromal illness, he explained.

The investigators focused on pneumonia in childhood and adolescence as a potential trigger for MS because pneumonia results in more profound and prolonged inflammation than do other common respiratory illnesses. For example, pneumonia has been shown to be linked to increased risks of cardiovascular disease and chronic kidney disease for up to 5 years after the infection.

Developmentally, age 11-15 years is a period defined by peripubertal reorganization and synaptogenesis, while synaptic pruning and axonal myelination are on the agenda at age 16-20 years, Dr. Montgomery observed.

The study of infectious mononucleosis as a potential risk factor for MS included 4,527 Swedish MS patients and 3.2 million controls, all born during 1970-2000 and followed until 2014. In this analysis, infectious mononucleosis occurring at age 11-15 years was associated with the greatest risk of subsequent MS, with an associated 3.47-fold greater risk of the neurologic disease versus that seen in patients who did not have infectious mononucleosis at age 11-15 years

“It does look like a causal association between Epstein-Barr virus infection and subsequent MS,” according to Dr. Montgomery.

He noted that a plausible mechanism by which lung inflammation could predispose future MS has been put forth by German investigators. Using an animal model, they demonstrated that autoreactive T cells are prepared in bronchus-associated lymphoid tissue and attain a migratory profile allowing them to cross the blood-brain barrier and induce CNS autoimmune disease (Nature. 2012 Aug 30;488[7413]:675-9).

All of this, as Dr. Montgomery emphasized, is speculative at this point in regard to MS pathogenesis. What is not speculative, he continued, is the solid evidence that infection-related mortality after diagnosis of MS has gone down substantially in the current era of newer disease-modifying treatments, as he and his coinvestigators have demonstrated (Neurology. 2017 Aug 8;89[6]:555-62).

“People with MS, compared to the general population, are still at increased risk, but not nearly as much as the infection-related mortality risk present back in the 1960s-80s. So things have improved somewhat,” Dr. Montgomery said.

Which MS patients are at increased risk for mortality caused by infection? His Swedish national registry research demonstrates that the risk is essentially confined to patients with secondary or primary progressive MS or an Expanded Disability Status Scale score of 6 or more.

Another new study he presented at the meeting focused on the types of infections that are more common in a contemporary MS population than in MS-free individuals. This Swedish national cohort study included 6,602 patients diagnosed with MS during 2008-2016 and 61,828 age-, sex-, and location-matched controls. Infections serious enough to have resulted in hospitalization occurred 2.59 times more frequently in the MS population. The risk of meningitis and encephalitis was increased 6.16-fold, opportunistic infections were 2.72-fold more frequent, the risk of urinary tract and kidney infections was increased 2.44-fold, herpes virus infections were increased 2.32-fold, and the combined rate of pneumonia and influenza was roughly double that seen in the matched general population.

Dr. Montgomery reported receiving research funding from F. Hoffmann–La Roche, Novartis, and AstraZeneca and serving on an advisory board for IQVIA.
 

[email protected]

SOURCE: Montgomery S. ECTRIMS 2019, Abstract 270.
 

STOCKHOLM – Early adolescence may be a period of heightened susceptibility to future development of multiple sclerosis (MS) resulting from exposure to pneumonia and other forms of lung inflammation, Scott Montgomery, PhD, said at the annual congress of the European Committee for Treatment and Research in Multiple Sclerosis.

This is speculative, he readily acknowledged, but it is a hypothesis supported by multiple lines of evidence provided by separate Swedish national health care registry studies he has led that showed associations between pneumonia or infectious mononucleosis occurring in early adolescence and increased risk of later MS.

These findings are consistent with the well-established observations that two other causes of lung irritation – cigarette smoking and exposure to organic solvents – are also linked to increased risk of MS (Neurology. 2018 Jul 31;91[5]:e455-62), noted Dr. Montgomery, head of the clinical epidemiology research group at Örebro (Sweden) University.

Moreover, he and his coinvestigators also found in yet another Swedish national registry cohort study that one concussion during adolescence was independently associated with a statistically significant 1.22-fold increased risk of later MS, while two or more were linked to a 2.33-fold increased risk. In contrast, concussions occurring before age 11 years were not associated with any increased risk of MS, which suggests an age-defined period of susceptibility (Ann Neurol. 2017 Oct;82[4]:554-61).

“There seems to be greater brain resilience in childhood as compared to adolescence,” Dr. Montgomery commented.

The new Swedish registry pneumonia study included 6,109 Swedish MS patients and 49,479 controls matched for age, gender, and locale. In an analysis adjusted for education level and history of infectious mononucleosis, history of having pneumonia at age 11-15 years was independently associated with a 2.8-fold increased risk of subsequent MS. Pneumonia occurring at age 16-20 years was associated with a more modest 1.38-fold increased risk, which did not achieve statistical significance, while pneumonia up to age 5 years or at age 6-10 years conferred no increased risk. The investigators restricted their analysis to cases of pneumonia occurring up to age 20 years because that is younger than the typical age of MS onset. The age restriction sidestepped the potential for confounding by reverse causation since it is known that pneumonia occurs with increased frequency in patients with MS.

Because MS patients also have an increased risk of urinary tract infections, Dr. Montgomery and coinvestigators also analyzed the same pediatric data set for UTI rates broken down by 5-year age groups. Rates were similar in individuals who later developed MS and in controls, which suggests that the observed increase in MS risk associated with pneumonia in early adolescence was not an expression of an MS prodromal illness, he explained.

The investigators focused on pneumonia in childhood and adolescence as a potential trigger for MS because pneumonia results in more profound and prolonged inflammation than do other common respiratory illnesses. For example, pneumonia has been shown to be linked to increased risks of cardiovascular disease and chronic kidney disease for up to 5 years after the infection.

Developmentally, age 11-15 years is a period defined by peripubertal reorganization and synaptogenesis, while synaptic pruning and axonal myelination are on the agenda at age 16-20 years, Dr. Montgomery observed.

The study of infectious mononucleosis as a potential risk factor for MS included 4,527 Swedish MS patients and 3.2 million controls, all born during 1970-2000 and followed until 2014. In this analysis, infectious mononucleosis occurring at age 11-15 years was associated with the greatest risk of subsequent MS, with an associated 3.47-fold greater risk of the neurologic disease versus that seen in patients who did not have infectious mononucleosis at age 11-15 years

“It does look like a causal association between Epstein-Barr virus infection and subsequent MS,” according to Dr. Montgomery.

He noted that a plausible mechanism by which lung inflammation could predispose future MS has been put forth by German investigators. Using an animal model, they demonstrated that autoreactive T cells are prepared in bronchus-associated lymphoid tissue and attain a migratory profile allowing them to cross the blood-brain barrier and induce CNS autoimmune disease (Nature. 2012 Aug 30;488[7413]:675-9).

All of this, as Dr. Montgomery emphasized, is speculative at this point in regard to MS pathogenesis. What is not speculative, he continued, is the solid evidence that infection-related mortality after diagnosis of MS has gone down substantially in the current era of newer disease-modifying treatments, as he and his coinvestigators have demonstrated (Neurology. 2017 Aug 8;89[6]:555-62).

“People with MS, compared to the general population, are still at increased risk, but not nearly as much as the infection-related mortality risk present back in the 1960s-80s. So things have improved somewhat,” Dr. Montgomery said.

Which MS patients are at increased risk for mortality caused by infection? His Swedish national registry research demonstrates that the risk is essentially confined to patients with secondary or primary progressive MS or an Expanded Disability Status Scale score of 6 or more.

Another new study he presented at the meeting focused on the types of infections that are more common in a contemporary MS population than in MS-free individuals. This Swedish national cohort study included 6,602 patients diagnosed with MS during 2008-2016 and 61,828 age-, sex-, and location-matched controls. Infections serious enough to have resulted in hospitalization occurred 2.59 times more frequently in the MS population. The risk of meningitis and encephalitis was increased 6.16-fold, opportunistic infections were 2.72-fold more frequent, the risk of urinary tract and kidney infections was increased 2.44-fold, herpes virus infections were increased 2.32-fold, and the combined rate of pneumonia and influenza was roughly double that seen in the matched general population.

Dr. Montgomery reported receiving research funding from F. Hoffmann–La Roche, Novartis, and AstraZeneca and serving on an advisory board for IQVIA.
 

[email protected]

SOURCE: Montgomery S. ECTRIMS 2019, Abstract 270.
 

STOCKHOLM – Early adolescence may be a period of heightened susceptibility to future development of multiple sclerosis (MS) resulting from exposure to pneumonia and other forms of lung inflammation, Scott Montgomery, PhD, said at the annual congress of the European Committee for Treatment and Research in Multiple Sclerosis.

This is speculative, he readily acknowledged, but it is a hypothesis supported by multiple lines of evidence provided by separate Swedish national health care registry studies he has led that showed associations between pneumonia or infectious mononucleosis occurring in early adolescence and increased risk of later MS.

These findings are consistent with the well-established observations that two other causes of lung irritation – cigarette smoking and exposure to organic solvents – are also linked to increased risk of MS (Neurology. 2018 Jul 31;91[5]:e455-62), noted Dr. Montgomery, head of the clinical epidemiology research group at Örebro (Sweden) University.

Moreover, he and his coinvestigators also found in yet another Swedish national registry cohort study that one concussion during adolescence was independently associated with a statistically significant 1.22-fold increased risk of later MS, while two or more were linked to a 2.33-fold increased risk. In contrast, concussions occurring before age 11 years were not associated with any increased risk of MS, which suggests an age-defined period of susceptibility (Ann Neurol. 2017 Oct;82[4]:554-61).

“There seems to be greater brain resilience in childhood as compared to adolescence,” Dr. Montgomery commented.

The new Swedish registry pneumonia study included 6,109 Swedish MS patients and 49,479 controls matched for age, gender, and locale. In an analysis adjusted for education level and history of infectious mononucleosis, history of having pneumonia at age 11-15 years was independently associated with a 2.8-fold increased risk of subsequent MS. Pneumonia occurring at age 16-20 years was associated with a more modest 1.38-fold increased risk, which did not achieve statistical significance, while pneumonia up to age 5 years or at age 6-10 years conferred no increased risk. The investigators restricted their analysis to cases of pneumonia occurring up to age 20 years because that is younger than the typical age of MS onset. The age restriction sidestepped the potential for confounding by reverse causation since it is known that pneumonia occurs with increased frequency in patients with MS.

Because MS patients also have an increased risk of urinary tract infections, Dr. Montgomery and coinvestigators also analyzed the same pediatric data set for UTI rates broken down by 5-year age groups. Rates were similar in individuals who later developed MS and in controls, which suggests that the observed increase in MS risk associated with pneumonia in early adolescence was not an expression of an MS prodromal illness, he explained.

The investigators focused on pneumonia in childhood and adolescence as a potential trigger for MS because pneumonia results in more profound and prolonged inflammation than do other common respiratory illnesses. For example, pneumonia has been shown to be linked to increased risks of cardiovascular disease and chronic kidney disease for up to 5 years after the infection.

Developmentally, age 11-15 years is a period defined by peripubertal reorganization and synaptogenesis, while synaptic pruning and axonal myelination are on the agenda at age 16-20 years, Dr. Montgomery observed.

The study of infectious mononucleosis as a potential risk factor for MS included 4,527 Swedish MS patients and 3.2 million controls, all born during 1970-2000 and followed until 2014. In this analysis, infectious mononucleosis occurring at age 11-15 years was associated with the greatest risk of subsequent MS, with an associated 3.47-fold greater risk of the neurologic disease versus that seen in patients who did not have infectious mononucleosis at age 11-15 years

“It does look like a causal association between Epstein-Barr virus infection and subsequent MS,” according to Dr. Montgomery.

He noted that a plausible mechanism by which lung inflammation could predispose future MS has been put forth by German investigators. Using an animal model, they demonstrated that autoreactive T cells are prepared in bronchus-associated lymphoid tissue and attain a migratory profile allowing them to cross the blood-brain barrier and induce CNS autoimmune disease (Nature. 2012 Aug 30;488[7413]:675-9).

All of this, as Dr. Montgomery emphasized, is speculative at this point in regard to MS pathogenesis. What is not speculative, he continued, is the solid evidence that infection-related mortality after diagnosis of MS has gone down substantially in the current era of newer disease-modifying treatments, as he and his coinvestigators have demonstrated (Neurology. 2017 Aug 8;89[6]:555-62).

“People with MS, compared to the general population, are still at increased risk, but not nearly as much as the infection-related mortality risk present back in the 1960s-80s. So things have improved somewhat,” Dr. Montgomery said.

Which MS patients are at increased risk for mortality caused by infection? His Swedish national registry research demonstrates that the risk is essentially confined to patients with secondary or primary progressive MS or an Expanded Disability Status Scale score of 6 or more.

Another new study he presented at the meeting focused on the types of infections that are more common in a contemporary MS population than in MS-free individuals. This Swedish national cohort study included 6,602 patients diagnosed with MS during 2008-2016 and 61,828 age-, sex-, and location-matched controls. Infections serious enough to have resulted in hospitalization occurred 2.59 times more frequently in the MS population. The risk of meningitis and encephalitis was increased 6.16-fold, opportunistic infections were 2.72-fold more frequent, the risk of urinary tract and kidney infections was increased 2.44-fold, herpes virus infections were increased 2.32-fold, and the combined rate of pneumonia and influenza was roughly double that seen in the matched general population.

Dr. Montgomery reported receiving research funding from F. Hoffmann–La Roche, Novartis, and AstraZeneca and serving on an advisory board for IQVIA.
 

[email protected]

SOURCE: Montgomery S. ECTRIMS 2019, Abstract 270.
 

CHARLOTTE, N.C. – New daily persistent headache (NDPH) is relatively common among pediatric patients presenting to a headache clinic, according to research presented at the 48th national meeting of the Child Neurology Society. Most children with NDPH fulfill criteria for its migraine subtype, and one-third of pediatric patients with NDPH have comorbid medication overuse headache (MOH).

NDPH is defined as a daily, unremitting headache that lasts for at least 3 months. “Not many studies on NDPH focus on pediatrics,” said Emily Pierce, from Children’s National Medical Center in Washington. NDPH “is considered to be one of the most intractable headaches in children. Children are able to tell that they’ve had this different type of headache because there’s some kind of onset that is very memorable.”

Ms. Pierce and colleagues conducted an observational study to describe the characteristics of NDPH in pediatric patients who presented to a headache program at a tertiary referral center. The researchers included pediatric patients who visited the headache clinic at Children’s National Medical Center between 2016 and 2018 in their analysis. All patients were enrolled in patient registry that had been approved by an independent review board. Ms. Pierce and colleagues queried the registry for NDPH and reviewed these records to examine participants’ clinical presentations.

The investigators identified 3,260 patient encounters during the study period. Of these encounters, 454 patients (13.9%) were identified as having NDPH. Patients with NDPH were predominantly female (78%) and white (72%). The median age of the sample was 14.8 years.

The frontal head region was the most common location of headache pain, which often had a throbbing quality and was associated with photophobia, phonophobia, nausea, and decreased activity. The median pain intensity was 6 of 10. Approximately 72% of patients had tried abortive medication, and 56% of patients had failed at least one abortive medication. Excedrin, ibuprofen, and acetaminophen were among the common failed abortive medications.

Furthermore, 36% of patients were diagnosed with MOH. The most commonly overused medication was ibuprofen. MOH “is also considered to be intractable for patients with NDPH,” said Ms. Pierce. “Typically, if the patient stops overusing that medication, they’ll find relief from their headaches. However, with our NDPH patients, when they stop overusing that medication, they still are having headaches associated with NDPH.”

The data indicated “a strong difference between our male and female patients,” said Ms. Pierce. Female patients reported significantly more instances of photophobia, phonophobia, nausea, and dizziness than did male patients. Overall, 78% of participants had a diagnosis of an additional comorbidity, such as head trauma (18%), anxiety (14%), depression (8%), or other (37%).

Observational studies of pediatric NDPH offer “a better way for our providers to diagnose these patients, and also to better understand them and help them figure out a treatment that may work,” said Ms. Pierce. In future research, she and her colleagues intend to examine blood work and potential genetic associations in pediatric patients with NDPH.

The study was not supported by funding, and the investigators had no disclosures.

[email protected]

SOURCE: Pierce E et al. CNS 2019, Abstract 100.

CHARLOTTE, N.C. – New daily persistent headache (NDPH) is relatively common among pediatric patients presenting to a headache clinic, according to research presented at the 48th national meeting of the Child Neurology Society. Most children with NDPH fulfill criteria for its migraine subtype, and one-third of pediatric patients with NDPH have comorbid medication overuse headache (MOH).

NDPH is defined as a daily, unremitting headache that lasts for at least 3 months. “Not many studies on NDPH focus on pediatrics,” said Emily Pierce, from Children’s National Medical Center in Washington. NDPH “is considered to be one of the most intractable headaches in children. Children are able to tell that they’ve had this different type of headache because there’s some kind of onset that is very memorable.”

Ms. Pierce and colleagues conducted an observational study to describe the characteristics of NDPH in pediatric patients who presented to a headache program at a tertiary referral center. The researchers included pediatric patients who visited the headache clinic at Children’s National Medical Center between 2016 and 2018 in their analysis. All patients were enrolled in patient registry that had been approved by an independent review board. Ms. Pierce and colleagues queried the registry for NDPH and reviewed these records to examine participants’ clinical presentations.

The investigators identified 3,260 patient encounters during the study period. Of these encounters, 454 patients (13.9%) were identified as having NDPH. Patients with NDPH were predominantly female (78%) and white (72%). The median age of the sample was 14.8 years.

The frontal head region was the most common location of headache pain, which often had a throbbing quality and was associated with photophobia, phonophobia, nausea, and decreased activity. The median pain intensity was 6 of 10. Approximately 72% of patients had tried abortive medication, and 56% of patients had failed at least one abortive medication. Excedrin, ibuprofen, and acetaminophen were among the common failed abortive medications.

Furthermore, 36% of patients were diagnosed with MOH. The most commonly overused medication was ibuprofen. MOH “is also considered to be intractable for patients with NDPH,” said Ms. Pierce. “Typically, if the patient stops overusing that medication, they’ll find relief from their headaches. However, with our NDPH patients, when they stop overusing that medication, they still are having headaches associated with NDPH.”

The data indicated “a strong difference between our male and female patients,” said Ms. Pierce. Female patients reported significantly more instances of photophobia, phonophobia, nausea, and dizziness than did male patients. Overall, 78% of participants had a diagnosis of an additional comorbidity, such as head trauma (18%), anxiety (14%), depression (8%), or other (37%).

Observational studies of pediatric NDPH offer “a better way for our providers to diagnose these patients, and also to better understand them and help them figure out a treatment that may work,” said Ms. Pierce. In future research, she and her colleagues intend to examine blood work and potential genetic associations in pediatric patients with NDPH.

The study was not supported by funding, and the investigators had no disclosures.

[email protected]

SOURCE: Pierce E et al. CNS 2019, Abstract 100.

CHARLOTTE, N.C. – New daily persistent headache (NDPH) is relatively common among pediatric patients presenting to a headache clinic, according to research presented at the 48th national meeting of the Child Neurology Society. Most children with NDPH fulfill criteria for its migraine subtype, and one-third of pediatric patients with NDPH have comorbid medication overuse headache (MOH).

NDPH is defined as a daily, unremitting headache that lasts for at least 3 months. “Not many studies on NDPH focus on pediatrics,” said Emily Pierce, from Children’s National Medical Center in Washington. NDPH “is considered to be one of the most intractable headaches in children. Children are able to tell that they’ve had this different type of headache because there’s some kind of onset that is very memorable.”

Ms. Pierce and colleagues conducted an observational study to describe the characteristics of NDPH in pediatric patients who presented to a headache program at a tertiary referral center. The researchers included pediatric patients who visited the headache clinic at Children’s National Medical Center between 2016 and 2018 in their analysis. All patients were enrolled in patient registry that had been approved by an independent review board. Ms. Pierce and colleagues queried the registry for NDPH and reviewed these records to examine participants’ clinical presentations.

The investigators identified 3,260 patient encounters during the study period. Of these encounters, 454 patients (13.9%) were identified as having NDPH. Patients with NDPH were predominantly female (78%) and white (72%). The median age of the sample was 14.8 years.

The frontal head region was the most common location of headache pain, which often had a throbbing quality and was associated with photophobia, phonophobia, nausea, and decreased activity. The median pain intensity was 6 of 10. Approximately 72% of patients had tried abortive medication, and 56% of patients had failed at least one abortive medication. Excedrin, ibuprofen, and acetaminophen were among the common failed abortive medications.

Furthermore, 36% of patients were diagnosed with MOH. The most commonly overused medication was ibuprofen. MOH “is also considered to be intractable for patients with NDPH,” said Ms. Pierce. “Typically, if the patient stops overusing that medication, they’ll find relief from their headaches. However, with our NDPH patients, when they stop overusing that medication, they still are having headaches associated with NDPH.”

The data indicated “a strong difference between our male and female patients,” said Ms. Pierce. Female patients reported significantly more instances of photophobia, phonophobia, nausea, and dizziness than did male patients. Overall, 78% of participants had a diagnosis of an additional comorbidity, such as head trauma (18%), anxiety (14%), depression (8%), or other (37%).

Observational studies of pediatric NDPH offer “a better way for our providers to diagnose these patients, and also to better understand them and help them figure out a treatment that may work,” said Ms. Pierce. In future research, she and her colleagues intend to examine blood work and potential genetic associations in pediatric patients with NDPH.

The study was not supported by funding, and the investigators had no disclosures.

[email protected]

SOURCE: Pierce E et al. CNS 2019, Abstract 100.

CHARLOTTE, N.C. – A significant proportion of children who present to headache clinics have joint hypermobility, according to data presented at the 48th national meeting of the Child Neurology Society. Furthermore, patients with joint hypermobility have a high rate of headache disability, while patients without joint hypermobility have less headache disability, according to Dhwani Sahjwani, MD, a resident at Inova Fairfax Hospital in Falls Church, Va., and colleagues.

While conducting research in the headache clinic at Children’s National Hospital in Washington, D.C., Dr. Sahjwani saw several children with joint hypermobility and a diagnosis of a disorder such as Ehlers-Danlos syndrome. She and her colleagues began analyzing patients to evaluate the potential association between joint hypermobility and headache disability in children. The investigators included pediatric patients examined in the headache clinic at Children’s National Medical Center between October 2018 and January 2019 in their study. All headache clinic patients were enrolled in a patient registry that had been approved by an independent review board.

Dr. Sahjwani and colleagues measured patients’ headache disability with the Headache Impact Test–6 (HIT-6) questionnaire. Scores of 60 or greater on this questionnaire indicate severe headache disability. The researchers assessed joint hypermobility using the Beighton scoring system. In this system, scores greater than 4 indicate joint hypermobility.

Dr. Sahjwani’s group scored 76 patients using the Beighton system and HIT-6 questionnaire. Participants’ median age was 13.7 years. Approximately 26% of patients had Beighton scores that indicated joint hypermobility. About 65% of the patients with joint hypermobility had a diagnosis of migraine without aura. In addition, 80% of patients with joint hypermobility had severe headache disability, according to the HIT-6 disability criteria. The average pain intensity in patients with hypermobile joints was 6.1 out of 10. Among participants without significant joint hypermobility, 90% had mild headache disability.

Patients with joint hypermobility and increased tissue elasticity “tend to have a lower threshold for pain, in general, in all parts of their bodies,” said Dr. Sahjwani. Greater headache severity might be expected in this population, “because they have more pain if they have hypermobile joints or tissue.”

Headache treatments for this population are based solely on the type of headache that each patient has. Patients with joint hypermobility and migraine, for example, are candidates for rescue medication and long-term prophylactic medications. “I don’t think the joint hypermobility is going to change how you manage their headaches,” said Dr. Sahjwani.

The study results suggest that, when children present with severely debilitating headaches, a neurologist should consider examining them for joint hypermobility “to see if they have another diagnosis, such as Ehlers-Danlos syndrome ... that has to be managed in addition to their headaches,” Dr. Sahjwani concluded.

The study was not supported by funding. The authors did not report any disclosures.

[email protected]

SOURCE: Sahjwani D et al. CNS 2019, Abstract 101.

CHARLOTTE, N.C. – A significant proportion of children who present to headache clinics have joint hypermobility, according to data presented at the 48th national meeting of the Child Neurology Society. Furthermore, patients with joint hypermobility have a high rate of headache disability, while patients without joint hypermobility have less headache disability, according to Dhwani Sahjwani, MD, a resident at Inova Fairfax Hospital in Falls Church, Va., and colleagues.

While conducting research in the headache clinic at Children’s National Hospital in Washington, D.C., Dr. Sahjwani saw several children with joint hypermobility and a diagnosis of a disorder such as Ehlers-Danlos syndrome. She and her colleagues began analyzing patients to evaluate the potential association between joint hypermobility and headache disability in children. The investigators included pediatric patients examined in the headache clinic at Children’s National Medical Center between October 2018 and January 2019 in their study. All headache clinic patients were enrolled in a patient registry that had been approved by an independent review board.

Dr. Sahjwani and colleagues measured patients’ headache disability with the Headache Impact Test–6 (HIT-6) questionnaire. Scores of 60 or greater on this questionnaire indicate severe headache disability. The researchers assessed joint hypermobility using the Beighton scoring system. In this system, scores greater than 4 indicate joint hypermobility.

Dr. Sahjwani’s group scored 76 patients using the Beighton system and HIT-6 questionnaire. Participants’ median age was 13.7 years. Approximately 26% of patients had Beighton scores that indicated joint hypermobility. About 65% of the patients with joint hypermobility had a diagnosis of migraine without aura. In addition, 80% of patients with joint hypermobility had severe headache disability, according to the HIT-6 disability criteria. The average pain intensity in patients with hypermobile joints was 6.1 out of 10. Among participants without significant joint hypermobility, 90% had mild headache disability.

Patients with joint hypermobility and increased tissue elasticity “tend to have a lower threshold for pain, in general, in all parts of their bodies,” said Dr. Sahjwani. Greater headache severity might be expected in this population, “because they have more pain if they have hypermobile joints or tissue.”

Headache treatments for this population are based solely on the type of headache that each patient has. Patients with joint hypermobility and migraine, for example, are candidates for rescue medication and long-term prophylactic medications. “I don’t think the joint hypermobility is going to change how you manage their headaches,” said Dr. Sahjwani.

The study results suggest that, when children present with severely debilitating headaches, a neurologist should consider examining them for joint hypermobility “to see if they have another diagnosis, such as Ehlers-Danlos syndrome ... that has to be managed in addition to their headaches,” Dr. Sahjwani concluded.

The study was not supported by funding. The authors did not report any disclosures.

[email protected]

SOURCE: Sahjwani D et al. CNS 2019, Abstract 101.

CHARLOTTE, N.C. – A significant proportion of children who present to headache clinics have joint hypermobility, according to data presented at the 48th national meeting of the Child Neurology Society. Furthermore, patients with joint hypermobility have a high rate of headache disability, while patients without joint hypermobility have less headache disability, according to Dhwani Sahjwani, MD, a resident at Inova Fairfax Hospital in Falls Church, Va., and colleagues.

While conducting research in the headache clinic at Children’s National Hospital in Washington, D.C., Dr. Sahjwani saw several children with joint hypermobility and a diagnosis of a disorder such as Ehlers-Danlos syndrome. She and her colleagues began analyzing patients to evaluate the potential association between joint hypermobility and headache disability in children. The investigators included pediatric patients examined in the headache clinic at Children’s National Medical Center between October 2018 and January 2019 in their study. All headache clinic patients were enrolled in a patient registry that had been approved by an independent review board.

Dr. Sahjwani and colleagues measured patients’ headache disability with the Headache Impact Test–6 (HIT-6) questionnaire. Scores of 60 or greater on this questionnaire indicate severe headache disability. The researchers assessed joint hypermobility using the Beighton scoring system. In this system, scores greater than 4 indicate joint hypermobility.

Dr. Sahjwani’s group scored 76 patients using the Beighton system and HIT-6 questionnaire. Participants’ median age was 13.7 years. Approximately 26% of patients had Beighton scores that indicated joint hypermobility. About 65% of the patients with joint hypermobility had a diagnosis of migraine without aura. In addition, 80% of patients with joint hypermobility had severe headache disability, according to the HIT-6 disability criteria. The average pain intensity in patients with hypermobile joints was 6.1 out of 10. Among participants without significant joint hypermobility, 90% had mild headache disability.

Patients with joint hypermobility and increased tissue elasticity “tend to have a lower threshold for pain, in general, in all parts of their bodies,” said Dr. Sahjwani. Greater headache severity might be expected in this population, “because they have more pain if they have hypermobile joints or tissue.”

Headache treatments for this population are based solely on the type of headache that each patient has. Patients with joint hypermobility and migraine, for example, are candidates for rescue medication and long-term prophylactic medications. “I don’t think the joint hypermobility is going to change how you manage their headaches,” said Dr. Sahjwani.

The study results suggest that, when children present with severely debilitating headaches, a neurologist should consider examining them for joint hypermobility “to see if they have another diagnosis, such as Ehlers-Danlos syndrome ... that has to be managed in addition to their headaches,” Dr. Sahjwani concluded.

The study was not supported by funding. The authors did not report any disclosures.

[email protected]

SOURCE: Sahjwani D et al. CNS 2019, Abstract 101.

Violent deaths have been rising among young people aged 10-19 years in the United States since 2007, driven largely by increases in suicides, according to the National Center for Health Statistics.

Death rates from suicide for children aged 10-14 years jumped by 178% from 2007 to 2017, while teenagers aged 15-19 years experienced a 76% increase over that period, with both changes reaching significance, the NCHS said in a recent data brief based on data from the National Vital Statistics System.

The actual rate for teens was higher to begin with, however, so in absolute terms the increase is larger for the older group. In 2007, deaths from suicide occurred at a rate of 6.7 per 100,000 persons for persons aged 15-19 years, and by 2017 that rate was up significantly to 11.8 per 100,000. Among children aged 10-14 years, the suicide-related death rate climbed from 0.9 per 100,000 in 2007 to 2.5 in 2014, the NCHS investigators reported.

The news was somewhat better on the other side of the violent death coin. Homicides are down by a significant 18% since 2000 among children aged 10-14 years, as the rate dropped from 1.1 per 100,000 in 2000 to 0.9 in 2017. The homicide rate since 2000 is down slightly for teens aged 15-19 years, but it has risen 32% in recent years, going from 6.6 deaths per 100,000 in 2013 to 8.7 in 2017, they said.

Suicide was the second-leading cause of death in both age groups in 2017, and homicide was third for those aged 15-19 and fifth among 10- to 14-year-olds, the investigators noted.

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Violent deaths have been rising among young people aged 10-19 years in the United States since 2007, driven largely by increases in suicides, according to the National Center for Health Statistics.

Death rates from suicide for children aged 10-14 years jumped by 178% from 2007 to 2017, while teenagers aged 15-19 years experienced a 76% increase over that period, with both changes reaching significance, the NCHS said in a recent data brief based on data from the National Vital Statistics System.

The actual rate for teens was higher to begin with, however, so in absolute terms the increase is larger for the older group. In 2007, deaths from suicide occurred at a rate of 6.7 per 100,000 persons for persons aged 15-19 years, and by 2017 that rate was up significantly to 11.8 per 100,000. Among children aged 10-14 years, the suicide-related death rate climbed from 0.9 per 100,000 in 2007 to 2.5 in 2014, the NCHS investigators reported.

The news was somewhat better on the other side of the violent death coin. Homicides are down by a significant 18% since 2000 among children aged 10-14 years, as the rate dropped from 1.1 per 100,000 in 2000 to 0.9 in 2017. The homicide rate since 2000 is down slightly for teens aged 15-19 years, but it has risen 32% in recent years, going from 6.6 deaths per 100,000 in 2013 to 8.7 in 2017, they said.

Suicide was the second-leading cause of death in both age groups in 2017, and homicide was third for those aged 15-19 and fifth among 10- to 14-year-olds, the investigators noted.

[email protected]

Violent deaths have been rising among young people aged 10-19 years in the United States since 2007, driven largely by increases in suicides, according to the National Center for Health Statistics.

Death rates from suicide for children aged 10-14 years jumped by 178% from 2007 to 2017, while teenagers aged 15-19 years experienced a 76% increase over that period, with both changes reaching significance, the NCHS said in a recent data brief based on data from the National Vital Statistics System.

The actual rate for teens was higher to begin with, however, so in absolute terms the increase is larger for the older group. In 2007, deaths from suicide occurred at a rate of 6.7 per 100,000 persons for persons aged 15-19 years, and by 2017 that rate was up significantly to 11.8 per 100,000. Among children aged 10-14 years, the suicide-related death rate climbed from 0.9 per 100,000 in 2007 to 2.5 in 2014, the NCHS investigators reported.

The news was somewhat better on the other side of the violent death coin. Homicides are down by a significant 18% since 2000 among children aged 10-14 years, as the rate dropped from 1.1 per 100,000 in 2000 to 0.9 in 2017. The homicide rate since 2000 is down slightly for teens aged 15-19 years, but it has risen 32% in recent years, going from 6.6 deaths per 100,000 in 2013 to 8.7 in 2017, they said.

Suicide was the second-leading cause of death in both age groups in 2017, and homicide was third for those aged 15-19 and fifth among 10- to 14-year-olds, the investigators noted.

[email protected]

Let’s suppose your first patient of the morning is a 2-month-old you have never seen before. The family arrives 10 minutes late because they are still getting the dressing-undressing-diaper change-car seat–adjusting thing worked out. Father is a computer programmer. Mother lists her occupation as nutrition counselor. The child is gaining. Breastfeeding seems to come naturally to the dyad.

KatarzynaBialasiewicz/Thinkstock

As the visit draws to a close, you take the matter-of-fact approach and say, “The nurse will be in shortly with the vaccines do you have any questions.” Well ... it turns out the parents don’t feel comfortable with vaccines. They claim to understand the science and feel that vaccines make sense for some families. But they feel that for themselves, with a healthy lifestyle and God’s benevolence their son will be protected without having to introduce a host of foreign substances into his body.

What word best describes your reaction? Anger? Frustration? Disappointment (in our education system)? Maybe you’re angry at yourself for failing to make it clear in your office pamphlet and social media feeds that to protect your other patients, you no longer accept families who refuse immunizations for the common childhood diseases.

The American Academy of Pediatrics says it feels your pain, and its Annual Leadership Forum made eliminating nonmedical vaccine exemption laws its top priority in 2019. As part of its effort to help, the AAP Board of Directors was asked to advocate for the creation of a toolkit of strategies for Academy chapters facing the challenge of nonmedical exemptions. As an initial step to this process, three physicians in the department of pediatrics at the Denver Health Medical Center have begun interviewing religious leaders in hopes of developing “clergy-specific vaccine educational materials and deriv[ing] best practices for engaging them as vaccination advocates.” The investigators describe their plan and initial findings in Pediatrics (2019 Oct. doi: 10.1542/peds.2019-0933). Although they acknowledged that their efforts may not provide a quick solution to the nonmedical exemption problem, they hope that including more stakeholders and engendering trust will help future discussions.

Fourteen pages deeper into that issue of Pediatrics is the runner-up submission of this year’s Section on Pediatric Trainees essay competition titled “What I Learned From the Antivaccine Movement” (2019 Oct. doi: 10.1542/peds.2019-2384). Alana C. Ju, MD, describes the 2-hour ordeal she endured to testify at the California State Capitol in support of a state Senate bill aimed at tightening the regulations for vaccine medical exemptions. Totally unprepared for the “level of vitriol” aimed at her and other supporters of the bill, she was “accused of violating her duty as” a pediatrician because she was failing to protect children. The supporters were called “greedy, ignorant, and negligent.”

To her credit, Dr. Ju was able to step back from this assault and began looking at the faces of her accusers and learned that, “they too, felt strongly about children’s health.” She realized that “focusing on perceived ignorance is counterproductive.” She now hopes that by focusing on the shared goal of what is best for children, “we can all be better advocates.”

Both of these articles have a warm sort of kumbaya feel about them. It never is a bad idea to learn more about those with whom we disagree. But before huddling up too close to the campfire, we must realize that there is good evidence that sharing the scientific data with vaccine-hesitant parents doesn’t convert them into vaccine acceptors. In fact, it may strengthen their resolve to resist (Nyhan et al. “Effective Messages in Vaccine Promotion: A Randomized Trial,” Pediatrics. 2014 Apr;133[4] e835-42).

We are unlikely to convert many anti-vaxxers by sitting down together. Our target audience needs to be legislators and the majority of people who do vaccinate their children. These are the voters who will support legislation to eliminate nonmedical vaccine exemptions. To characterize anti-vaxxers as despicable ignorants is untrue and serves no purpose. We all do care about the health of children. However, the evidence is clear that nonmedical exemptions are threatening the population at large and need to be curtailed.

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.” Email him at [email protected].

*This article has been updated 1/22/2020.

Let’s suppose your first patient of the morning is a 2-month-old you have never seen before. The family arrives 10 minutes late because they are still getting the dressing-undressing-diaper change-car seat–adjusting thing worked out. Father is a computer programmer. Mother lists her occupation as nutrition counselor. The child is gaining. Breastfeeding seems to come naturally to the dyad.

KatarzynaBialasiewicz/Thinkstock

As the visit draws to a close, you take the matter-of-fact approach and say, “The nurse will be in shortly with the vaccines do you have any questions.” Well ... it turns out the parents don’t feel comfortable with vaccines. They claim to understand the science and feel that vaccines make sense for some families. But they feel that for themselves, with a healthy lifestyle and God’s benevolence their son will be protected without having to introduce a host of foreign substances into his body.

What word best describes your reaction? Anger? Frustration? Disappointment (in our education system)? Maybe you’re angry at yourself for failing to make it clear in your office pamphlet and social media feeds that to protect your other patients, you no longer accept families who refuse immunizations for the common childhood diseases.

The American Academy of Pediatrics says it feels your pain, and its Annual Leadership Forum made eliminating nonmedical vaccine exemption laws its top priority in 2019. As part of its effort to help, the AAP Board of Directors was asked to advocate for the creation of a toolkit of strategies for Academy chapters facing the challenge of nonmedical exemptions. As an initial step to this process, three physicians in the department of pediatrics at the Denver Health Medical Center have begun interviewing religious leaders in hopes of developing “clergy-specific vaccine educational materials and deriv[ing] best practices for engaging them as vaccination advocates.” The investigators describe their plan and initial findings in Pediatrics (2019 Oct. doi: 10.1542/peds.2019-0933). Although they acknowledged that their efforts may not provide a quick solution to the nonmedical exemption problem, they hope that including more stakeholders and engendering trust will help future discussions.

Fourteen pages deeper into that issue of Pediatrics is the runner-up submission of this year’s Section on Pediatric Trainees essay competition titled “What I Learned From the Antivaccine Movement” (2019 Oct. doi: 10.1542/peds.2019-2384). Alana C. Ju, MD, describes the 2-hour ordeal she endured to testify at the California State Capitol in support of a state Senate bill aimed at tightening the regulations for vaccine medical exemptions. Totally unprepared for the “level of vitriol” aimed at her and other supporters of the bill, she was “accused of violating her duty as” a pediatrician because she was failing to protect children. The supporters were called “greedy, ignorant, and negligent.”

To her credit, Dr. Ju was able to step back from this assault and began looking at the faces of her accusers and learned that, “they too, felt strongly about children’s health.” She realized that “focusing on perceived ignorance is counterproductive.” She now hopes that by focusing on the shared goal of what is best for children, “we can all be better advocates.”

Both of these articles have a warm sort of kumbaya feel about them. It never is a bad idea to learn more about those with whom we disagree. But before huddling up too close to the campfire, we must realize that there is good evidence that sharing the scientific data with vaccine-hesitant parents doesn’t convert them into vaccine acceptors. In fact, it may strengthen their resolve to resist (Nyhan et al. “Effective Messages in Vaccine Promotion: A Randomized Trial,” Pediatrics. 2014 Apr;133[4] e835-42).

We are unlikely to convert many anti-vaxxers by sitting down together. Our target audience needs to be legislators and the majority of people who do vaccinate their children. These are the voters who will support legislation to eliminate nonmedical vaccine exemptions. To characterize anti-vaxxers as despicable ignorants is untrue and serves no purpose. We all do care about the health of children. However, the evidence is clear that nonmedical exemptions are threatening the population at large and need to be curtailed.

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.” Email him at [email protected].

*This article has been updated 1/22/2020.

Let’s suppose your first patient of the morning is a 2-month-old you have never seen before. The family arrives 10 minutes late because they are still getting the dressing-undressing-diaper change-car seat–adjusting thing worked out. Father is a computer programmer. Mother lists her occupation as nutrition counselor. The child is gaining. Breastfeeding seems to come naturally to the dyad.

KatarzynaBialasiewicz/Thinkstock

As the visit draws to a close, you take the matter-of-fact approach and say, “The nurse will be in shortly with the vaccines do you have any questions.” Well ... it turns out the parents don’t feel comfortable with vaccines. They claim to understand the science and feel that vaccines make sense for some families. But they feel that for themselves, with a healthy lifestyle and God’s benevolence their son will be protected without having to introduce a host of foreign substances into his body.

What word best describes your reaction? Anger? Frustration? Disappointment (in our education system)? Maybe you’re angry at yourself for failing to make it clear in your office pamphlet and social media feeds that to protect your other patients, you no longer accept families who refuse immunizations for the common childhood diseases.

The American Academy of Pediatrics says it feels your pain, and its Annual Leadership Forum made eliminating nonmedical vaccine exemption laws its top priority in 2019. As part of its effort to help, the AAP Board of Directors was asked to advocate for the creation of a toolkit of strategies for Academy chapters facing the challenge of nonmedical exemptions. As an initial step to this process, three physicians in the department of pediatrics at the Denver Health Medical Center have begun interviewing religious leaders in hopes of developing “clergy-specific vaccine educational materials and deriv[ing] best practices for engaging them as vaccination advocates.” The investigators describe their plan and initial findings in Pediatrics (2019 Oct. doi: 10.1542/peds.2019-0933). Although they acknowledged that their efforts may not provide a quick solution to the nonmedical exemption problem, they hope that including more stakeholders and engendering trust will help future discussions.

Fourteen pages deeper into that issue of Pediatrics is the runner-up submission of this year’s Section on Pediatric Trainees essay competition titled “What I Learned From the Antivaccine Movement” (2019 Oct. doi: 10.1542/peds.2019-2384). Alana C. Ju, MD, describes the 2-hour ordeal she endured to testify at the California State Capitol in support of a state Senate bill aimed at tightening the regulations for vaccine medical exemptions. Totally unprepared for the “level of vitriol” aimed at her and other supporters of the bill, she was “accused of violating her duty as” a pediatrician because she was failing to protect children. The supporters were called “greedy, ignorant, and negligent.”

To her credit, Dr. Ju was able to step back from this assault and began looking at the faces of her accusers and learned that, “they too, felt strongly about children’s health.” She realized that “focusing on perceived ignorance is counterproductive.” She now hopes that by focusing on the shared goal of what is best for children, “we can all be better advocates.”

Both of these articles have a warm sort of kumbaya feel about them. It never is a bad idea to learn more about those with whom we disagree. But before huddling up too close to the campfire, we must realize that there is good evidence that sharing the scientific data with vaccine-hesitant parents doesn’t convert them into vaccine acceptors. In fact, it may strengthen their resolve to resist (Nyhan et al. “Effective Messages in Vaccine Promotion: A Randomized Trial,” Pediatrics. 2014 Apr;133[4] e835-42).

We are unlikely to convert many anti-vaxxers by sitting down together. Our target audience needs to be legislators and the majority of people who do vaccinate their children. These are the voters who will support legislation to eliminate nonmedical vaccine exemptions. To characterize anti-vaxxers as despicable ignorants is untrue and serves no purpose. We all do care about the health of children. However, the evidence is clear that nonmedical exemptions are threatening the population at large and need to be curtailed.

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.” Email him at [email protected].

*This article has been updated 1/22/2020.

The Centers for Disease Control and Prevention’s Advisory Committee on Immunization Practices voted unanimously to approve the child and adolescent immunization schedule for 2020.

Yarinca/istockphoto

The changes to the child and adolescent immunization schedule for 2020 “incorporate recommendations that have occurred and are easy to use at point of care by busy providers,” Candice Robinson, MD, MPH, of the CDC’s National Center for Immunization and Respiratory Diseases, said at the CDC’s October meeting of ACIP. Updates reflect changes in language in the adult vaccination schedule, notably the change in the definition of “contraindication.” The updated wording in the Notes substitutes “not recommended or contraindicated” instead of the word “contraindicated” only.

Another notable change was the addition of information on adolescent vaccination of children who received the meningococcal ACWY vaccine before 10 years of age. For “children in whom boosters are not recommended due to an ongoing or increased risk of meningococcal disease” (such as a healthy child traveling to an endemic area), they should receive MenACWY according to the recommended adolescent schedule. But those children for whom boosters are recommended because of increased disease risk from conditions including complement deficiency, HIV, or asplenia should “follow the booster schedule for persons at increased risk.”

Other changes include restructuring of the notes for the live attenuated influenza vaccine (LAIV) in special situations. The schedule now uses a bulleted list to show that LAIV should not be used in the following circumstances:

• Having history of severe allergic reaction to a previous vaccine or vaccine component.
• Using aspirin or a salicylate-containing medication.
• Being aged 2-4 years with a history of asthma or wheezing.
• Having immunocompromised conditions.
• Having anatomic or functional asplenia.
• Having cochlear implants.
• Experiencing cerebrospinal fluid–oropharyngeal communication.
• Having immunocompromised close contacts or caregivers.
• Being pregnant.
• Having received flu antivirals within the previous 48 hours.

In addition, language on shared clinical decision-making was added to the notes on the meningococcal B vaccine for adolescents and young adults aged 18-23 years not at increased risk. Based on shared clinical decision making, the recommendation is a “two-dose series of Bexsero at least 1 month apart” or “two-dose series of Trumenba at least 6 months apart; if dose two is administered earlier than 6 months, administer a third dose at least 4 months after dose two.”

Several vaccines’ Notes sections, including hepatitis B and meningococcal disease, added links to detailed recommendations in the corresponding issues of the CDC’s Morbidity and Mortality Weekly Report, to allow clinicians easy access to additional information.

View the current Child & Adolescent Vaccination Schedule here.

The ACIP members had no financial conflicts to disclose.
 

The Centers for Disease Control and Prevention’s Advisory Committee on Immunization Practices voted unanimously to approve the child and adolescent immunization schedule for 2020.

Yarinca/istockphoto

The changes to the child and adolescent immunization schedule for 2020 “incorporate recommendations that have occurred and are easy to use at point of care by busy providers,” Candice Robinson, MD, MPH, of the CDC’s National Center for Immunization and Respiratory Diseases, said at the CDC’s October meeting of ACIP. Updates reflect changes in language in the adult vaccination schedule, notably the change in the definition of “contraindication.” The updated wording in the Notes substitutes “not recommended or contraindicated” instead of the word “contraindicated” only.

Another notable change was the addition of information on adolescent vaccination of children who received the meningococcal ACWY vaccine before 10 years of age. For “children in whom boosters are not recommended due to an ongoing or increased risk of meningococcal disease” (such as a healthy child traveling to an endemic area), they should receive MenACWY according to the recommended adolescent schedule. But those children for whom boosters are recommended because of increased disease risk from conditions including complement deficiency, HIV, or asplenia should “follow the booster schedule for persons at increased risk.”

Other changes include restructuring of the notes for the live attenuated influenza vaccine (LAIV) in special situations. The schedule now uses a bulleted list to show that LAIV should not be used in the following circumstances:

• Having history of severe allergic reaction to a previous vaccine or vaccine component.
• Using aspirin or a salicylate-containing medication.
• Being aged 2-4 years with a history of asthma or wheezing.
• Having immunocompromised conditions.
• Having anatomic or functional asplenia.
• Having cochlear implants.
• Experiencing cerebrospinal fluid–oropharyngeal communication.
• Having immunocompromised close contacts or caregivers.
• Being pregnant.
• Having received flu antivirals within the previous 48 hours.

In addition, language on shared clinical decision-making was added to the notes on the meningococcal B vaccine for adolescents and young adults aged 18-23 years not at increased risk. Based on shared clinical decision making, the recommendation is a “two-dose series of Bexsero at least 1 month apart” or “two-dose series of Trumenba at least 6 months apart; if dose two is administered earlier than 6 months, administer a third dose at least 4 months after dose two.”

Several vaccines’ Notes sections, including hepatitis B and meningococcal disease, added links to detailed recommendations in the corresponding issues of the CDC’s Morbidity and Mortality Weekly Report, to allow clinicians easy access to additional information.

View the current Child & Adolescent Vaccination Schedule here.

The ACIP members had no financial conflicts to disclose.
 

The Centers for Disease Control and Prevention’s Advisory Committee on Immunization Practices voted unanimously to approve the child and adolescent immunization schedule for 2020.

Yarinca/istockphoto

The changes to the child and adolescent immunization schedule for 2020 “incorporate recommendations that have occurred and are easy to use at point of care by busy providers,” Candice Robinson, MD, MPH, of the CDC’s National Center for Immunization and Respiratory Diseases, said at the CDC’s October meeting of ACIP. Updates reflect changes in language in the adult vaccination schedule, notably the change in the definition of “contraindication.” The updated wording in the Notes substitutes “not recommended or contraindicated” instead of the word “contraindicated” only.

Another notable change was the addition of information on adolescent vaccination of children who received the meningococcal ACWY vaccine before 10 years of age. For “children in whom boosters are not recommended due to an ongoing or increased risk of meningococcal disease” (such as a healthy child traveling to an endemic area), they should receive MenACWY according to the recommended adolescent schedule. But those children for whom boosters are recommended because of increased disease risk from conditions including complement deficiency, HIV, or asplenia should “follow the booster schedule for persons at increased risk.”

Other changes include restructuring of the notes for the live attenuated influenza vaccine (LAIV) in special situations. The schedule now uses a bulleted list to show that LAIV should not be used in the following circumstances:

• Having history of severe allergic reaction to a previous vaccine or vaccine component.
• Using aspirin or a salicylate-containing medication.
• Being aged 2-4 years with a history of asthma or wheezing.
• Having immunocompromised conditions.
• Having anatomic or functional asplenia.
• Having cochlear implants.
• Experiencing cerebrospinal fluid–oropharyngeal communication.
• Having immunocompromised close contacts or caregivers.
• Being pregnant.
• Having received flu antivirals within the previous 48 hours.

In addition, language on shared clinical decision-making was added to the notes on the meningococcal B vaccine for adolescents and young adults aged 18-23 years not at increased risk. Based on shared clinical decision making, the recommendation is a “two-dose series of Bexsero at least 1 month apart” or “two-dose series of Trumenba at least 6 months apart; if dose two is administered earlier than 6 months, administer a third dose at least 4 months after dose two.”

Several vaccines’ Notes sections, including hepatitis B and meningococcal disease, added links to detailed recommendations in the corresponding issues of the CDC’s Morbidity and Mortality Weekly Report, to allow clinicians easy access to additional information.

View the current Child & Adolescent Vaccination Schedule here.

The ACIP members had no financial conflicts to disclose.
 

Presenters

Jared Austin, MD, FAAP

Ryan Bode, MD, FAAP

Jeremy Kern, MD, FAAP

Mary Ottolini, MD, MPH, MEd, FAAP

Stacy Pierson, MD, FAAP

Mary Rocha, MD, MPH, FAAP

Susan Walley, MD, CTTS, FAAP

Session summary

Professional development sessions at the Pediatric Hospital Medicine 2019 conference intended to further educate pediatric hospitalists and advance their careers. In November 2019, many pediatric hospitalists will be taking subspecialty PHM boards for the very first time. This PHM19 session had clear objectives: to describe the American Board of Pediatrics (ABP) PHM board content areas, to analyze common knowledge gaps in PREP PHM, and to examine different approaches to clinical management of PHM patients.

The session opened with a brief history of a vision of PHM and the story of its realization. In 2016, a group of eight stalwart writers, four new writers, and three editors created PREP 2018 and 2019 questions that were released in full prior to November 2019. The ABP will offer the board exam in 2019, 2021, and 2023

The exam content domains include the following:

• Medical conditions.
• Behavioral and mental health conditions.
• Newborn care.
• Children with medical complexity.
• Medical procedures.
• Patient and family centered care.
• Transitions of care.
• Quality improvement, patient safety and system based improvement.
• Evidence-based, high-value care.
• Advocacy and leadership.
• Ethics, legal issues, and human rights.
• Teaching and education.
• Core knowledge in scholarly activities.

Each question consists of a case vignette, question, response choices, critiques, PREP PEARLs, and references. There are also additional PREP Ponder Points that intend to prompt reflection on practice change.

For the remainder of the session presenters reviewed the PHM PREP questions that were most frequently answered incorrectly. Some of the topics included: asthma vs. anaphylaxis, venous thromboembolism prophylaxis in surgical patients, postoperative feeding regimens, transmission-based precautions, febrile neonates, Ebola, medical child abuse, absolute indications for intubation, toxic megacolon, palivizumab prophylaxis guidelines, key driver diagrams, and infantile hemangiomas.
 

Key takeaway

Pediatric hospitalists all over the United States will for the first time ever take PHM boards in November 2019. The exam content domains were demonstrated in detail, and several often incorrectly answered PREP questions were presented and discussed.

Dr. Giordano is assistant professor in pediatrics at Columbia University Medical Center, New York.

Presenters

Jared Austin, MD, FAAP

Ryan Bode, MD, FAAP

Jeremy Kern, MD, FAAP

Mary Ottolini, MD, MPH, MEd, FAAP

Stacy Pierson, MD, FAAP

Mary Rocha, MD, MPH, FAAP

Susan Walley, MD, CTTS, FAAP

Session summary

Professional development sessions at the Pediatric Hospital Medicine 2019 conference intended to further educate pediatric hospitalists and advance their careers. In November 2019, many pediatric hospitalists will be taking subspecialty PHM boards for the very first time. This PHM19 session had clear objectives: to describe the American Board of Pediatrics (ABP) PHM board content areas, to analyze common knowledge gaps in PREP PHM, and to examine different approaches to clinical management of PHM patients.

The session opened with a brief history of a vision of PHM and the story of its realization. In 2016, a group of eight stalwart writers, four new writers, and three editors created PREP 2018 and 2019 questions that were released in full prior to November 2019. The ABP will offer the board exam in 2019, 2021, and 2023

The exam content domains include the following:

• Medical conditions.
• Behavioral and mental health conditions.
• Newborn care.
• Children with medical complexity.
• Medical procedures.
• Patient and family centered care.
• Transitions of care.
• Quality improvement, patient safety and system based improvement.
• Evidence-based, high-value care.
• Advocacy and leadership.
• Ethics, legal issues, and human rights.
• Teaching and education.
• Core knowledge in scholarly activities.

Each question consists of a case vignette, question, response choices, critiques, PREP PEARLs, and references. There are also additional PREP Ponder Points that intend to prompt reflection on practice change.

For the remainder of the session presenters reviewed the PHM PREP questions that were most frequently answered incorrectly. Some of the topics included: asthma vs. anaphylaxis, venous thromboembolism prophylaxis in surgical patients, postoperative feeding regimens, transmission-based precautions, febrile neonates, Ebola, medical child abuse, absolute indications for intubation, toxic megacolon, palivizumab prophylaxis guidelines, key driver diagrams, and infantile hemangiomas.
 

Key takeaway

Pediatric hospitalists all over the United States will for the first time ever take PHM boards in November 2019. The exam content domains were demonstrated in detail, and several often incorrectly answered PREP questions were presented and discussed.

Dr. Giordano is assistant professor in pediatrics at Columbia University Medical Center, New York.

Presenters

Jared Austin, MD, FAAP

Ryan Bode, MD, FAAP

Jeremy Kern, MD, FAAP

Mary Ottolini, MD, MPH, MEd, FAAP

Stacy Pierson, MD, FAAP

Mary Rocha, MD, MPH, FAAP

Susan Walley, MD, CTTS, FAAP

Session summary

Professional development sessions at the Pediatric Hospital Medicine 2019 conference intended to further educate pediatric hospitalists and advance their careers. In November 2019, many pediatric hospitalists will be taking subspecialty PHM boards for the very first time. This PHM19 session had clear objectives: to describe the American Board of Pediatrics (ABP) PHM board content areas, to analyze common knowledge gaps in PREP PHM, and to examine different approaches to clinical management of PHM patients.

The session opened with a brief history of a vision of PHM and the story of its realization. In 2016, a group of eight stalwart writers, four new writers, and three editors created PREP 2018 and 2019 questions that were released in full prior to November 2019. The ABP will offer the board exam in 2019, 2021, and 2023

The exam content domains include the following:

• Medical conditions.
• Behavioral and mental health conditions.
• Newborn care.
• Children with medical complexity.
• Medical procedures.
• Patient and family centered care.
• Transitions of care.
• Quality improvement, patient safety and system based improvement.
• Evidence-based, high-value care.
• Advocacy and leadership.
• Ethics, legal issues, and human rights.
• Teaching and education.
• Core knowledge in scholarly activities.

Each question consists of a case vignette, question, response choices, critiques, PREP PEARLs, and references. There are also additional PREP Ponder Points that intend to prompt reflection on practice change.

For the remainder of the session presenters reviewed the PHM PREP questions that were most frequently answered incorrectly. Some of the topics included: asthma vs. anaphylaxis, venous thromboembolism prophylaxis in surgical patients, postoperative feeding regimens, transmission-based precautions, febrile neonates, Ebola, medical child abuse, absolute indications for intubation, toxic megacolon, palivizumab prophylaxis guidelines, key driver diagrams, and infantile hemangiomas.
 

Key takeaway

Pediatric hospitalists all over the United States will for the first time ever take PHM boards in November 2019. The exam content domains were demonstrated in detail, and several often incorrectly answered PREP questions were presented and discussed.

Dr. Giordano is assistant professor in pediatrics at Columbia University Medical Center, New York.

The Food and Drug Administration has approved onabotulinumtoxinA (Botox) for treatment of pediatric lower limb spasticity in patients aged 2-17 years, excluding those in whom it is associated with cerebral palsy, according to an announcement from Allergan.

Olivier Le Moal/Getty Images

The approval is based on a phase 3 study evaluating safety and efficacy in more than 300 patients with lower limb spasticity. Although patients with cerebral palsy were included in the study, they’re excluded from this indication. Orphan Drug Exclusivity prevents it from being indicated for lower limb spasticity in cerebral palsy because abobotulinumtoxinA (Dysport) already has marketing exclusivity for the indication. Botox also is indicated for children aged 2-17 years of age with upper limb spasticity, as well as nine other indications.

OnabotulinumtoxinA comes with warnings, including problems of swallowing, speaking, or breathing and even risk of spread of the toxin. It also may cause loss of strength or general muscle weakness, vision problems, or dizziness within hours or weeks of administration. Serious and sometimes immediate allergic reactions have been reported. Patients and health care professionals should discuss various concerns before treatment, including whether the patient has recently received antibiotics by injection, or has taken muscle relaxants, allergy or cold medicine, sleep medicine, and aspirinlike products or blood thinners. It’s important to note that the dose of onabotulinumtoxinA is not the same as that for other botulinum toxin products. The full prescribing information is available on the Allergan website.

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The Food and Drug Administration has approved onabotulinumtoxinA (Botox) for treatment of pediatric lower limb spasticity in patients aged 2-17 years, excluding those in whom it is associated with cerebral palsy, according to an announcement from Allergan.

Olivier Le Moal/Getty Images

The approval is based on a phase 3 study evaluating safety and efficacy in more than 300 patients with lower limb spasticity. Although patients with cerebral palsy were included in the study, they’re excluded from this indication. Orphan Drug Exclusivity prevents it from being indicated for lower limb spasticity in cerebral palsy because abobotulinumtoxinA (Dysport) already has marketing exclusivity for the indication. Botox also is indicated for children aged 2-17 years of age with upper limb spasticity, as well as nine other indications.

OnabotulinumtoxinA comes with warnings, including problems of swallowing, speaking, or breathing and even risk of spread of the toxin. It also may cause loss of strength or general muscle weakness, vision problems, or dizziness within hours or weeks of administration. Serious and sometimes immediate allergic reactions have been reported. Patients and health care professionals should discuss various concerns before treatment, including whether the patient has recently received antibiotics by injection, or has taken muscle relaxants, allergy or cold medicine, sleep medicine, and aspirinlike products or blood thinners. It’s important to note that the dose of onabotulinumtoxinA is not the same as that for other botulinum toxin products. The full prescribing information is available on the Allergan website.

[email protected]

The Food and Drug Administration has approved onabotulinumtoxinA (Botox) for treatment of pediatric lower limb spasticity in patients aged 2-17 years, excluding those in whom it is associated with cerebral palsy, according to an announcement from Allergan.

Olivier Le Moal/Getty Images

The approval is based on a phase 3 study evaluating safety and efficacy in more than 300 patients with lower limb spasticity. Although patients with cerebral palsy were included in the study, they’re excluded from this indication. Orphan Drug Exclusivity prevents it from being indicated for lower limb spasticity in cerebral palsy because abobotulinumtoxinA (Dysport) already has marketing exclusivity for the indication. Botox also is indicated for children aged 2-17 years of age with upper limb spasticity, as well as nine other indications.

OnabotulinumtoxinA comes with warnings, including problems of swallowing, speaking, or breathing and even risk of spread of the toxin. It also may cause loss of strength or general muscle weakness, vision problems, or dizziness within hours or weeks of administration. Serious and sometimes immediate allergic reactions have been reported. Patients and health care professionals should discuss various concerns before treatment, including whether the patient has recently received antibiotics by injection, or has taken muscle relaxants, allergy or cold medicine, sleep medicine, and aspirinlike products or blood thinners. It’s important to note that the dose of onabotulinumtoxinA is not the same as that for other botulinum toxin products. The full prescribing information is available on the Allergan website.

[email protected]

The Centers for Disease Control and Prevention’s Advisory Committee on Immunization Practices voted unanimously to approve the adult immunization schedule for 2020, although some fine-tuning may occur before publication.

MarianVejcik/Getty Images

“Some of the wordsmithing may be done later,” ACIP executive secretary Amanda Cohn, MD, said at the ACIP October meeting.

These small changes revolved mainly around how much wording to include in the current color block tables versus including the information in the notes section.

Key updates to the schedule included a change in wording for the definition of the red bars on the table to include “not recommended or contraindicated” instead of only the word “contraindicated.” Committee members were especially interested in changing this wording to guide clinicians in use of the live attenuated influenza vaccine because of its potential value in vaccinating health care personnel.

Other updates include language that vaccination of adolescents and young adults aged 16-23 years who are not at increased risk for meningococcal disease should be vaccinated as follows: “Based on shared clinical decision making, 2-dose series MenB-4C at least 1 month apart or 2-dose series MenB-FHbp at 0, 6 months.”

Similarly, clinical decision-making language was added to the notes for the pneumococcal polysaccharide vaccine (PPSV23) and the 13-valent pneumococcal conjugate vaccine (PCV13).

The routine vaccination calls for only one dose of PPSV23 given on or after the individual’s 65th birthday. Then, based on shared clinical decision making, a dose of PCV13 is recommended for immunocompetent individuals aged 65 years and older. The notes also state that, based on shared clinical decision making, PCV13 and PPSV23 should not be given in the same visit and, if both will be given, PCV13 should be first and should be given 1 year before PPSV23. In addition, “PPSV23 should be given at least 5 years after any previous PPSV23 dose.”

The schedule also adds shared clinical decision making to the notes on human papillomavirus vaccination for adults aged 27-45 years.

The committee members acknowledged the increasing complexity of the adult vaccination schedule, but several members agreed that it is accessible to many clinicians.

“We can’t let the perfect be the enemy of the good” said Jason Goldman, MD, liaison representing the American College of Physicians. “Those who want to learn the schedule will learn it; the health system will learn it,” even if not every specialist does.

The table “is something to draw you in,” said Sandra Fryhofer, MD, an internist who is liaison for the American Medical Association. The notes provide more details.

More specific information about contraindications for patients with cochlear implants, which also came up in the discussion, may be added to the schedule at a later date.

View the current adult vaccination schedule here.

The ACIP members had no financial conflicts to disclose.
 

The Centers for Disease Control and Prevention’s Advisory Committee on Immunization Practices voted unanimously to approve the adult immunization schedule for 2020, although some fine-tuning may occur before publication.

MarianVejcik/Getty Images

“Some of the wordsmithing may be done later,” ACIP executive secretary Amanda Cohn, MD, said at the ACIP October meeting.

These small changes revolved mainly around how much wording to include in the current color block tables versus including the information in the notes section.

Key updates to the schedule included a change in wording for the definition of the red bars on the table to include “not recommended or contraindicated” instead of only the word “contraindicated.” Committee members were especially interested in changing this wording to guide clinicians in use of the live attenuated influenza vaccine because of its potential value in vaccinating health care personnel.

Other updates include language that vaccination of adolescents and young adults aged 16-23 years who are not at increased risk for meningococcal disease should be vaccinated as follows: “Based on shared clinical decision making, 2-dose series MenB-4C at least 1 month apart or 2-dose series MenB-FHbp at 0, 6 months.”

Similarly, clinical decision-making language was added to the notes for the pneumococcal polysaccharide vaccine (PPSV23) and the 13-valent pneumococcal conjugate vaccine (PCV13).

The routine vaccination calls for only one dose of PPSV23 given on or after the individual’s 65th birthday. Then, based on shared clinical decision making, a dose of PCV13 is recommended for immunocompetent individuals aged 65 years and older. The notes also state that, based on shared clinical decision making, PCV13 and PPSV23 should not be given in the same visit and, if both will be given, PCV13 should be first and should be given 1 year before PPSV23. In addition, “PPSV23 should be given at least 5 years after any previous PPSV23 dose.”

The schedule also adds shared clinical decision making to the notes on human papillomavirus vaccination for adults aged 27-45 years.

The committee members acknowledged the increasing complexity of the adult vaccination schedule, but several members agreed that it is accessible to many clinicians.

“We can’t let the perfect be the enemy of the good” said Jason Goldman, MD, liaison representing the American College of Physicians. “Those who want to learn the schedule will learn it; the health system will learn it,” even if not every specialist does.

The table “is something to draw you in,” said Sandra Fryhofer, MD, an internist who is liaison for the American Medical Association. The notes provide more details.

More specific information about contraindications for patients with cochlear implants, which also came up in the discussion, may be added to the schedule at a later date.

View the current adult vaccination schedule here.

The ACIP members had no financial conflicts to disclose.
 

The Centers for Disease Control and Prevention’s Advisory Committee on Immunization Practices voted unanimously to approve the adult immunization schedule for 2020, although some fine-tuning may occur before publication.

MarianVejcik/Getty Images

“Some of the wordsmithing may be done later,” ACIP executive secretary Amanda Cohn, MD, said at the ACIP October meeting.

These small changes revolved mainly around how much wording to include in the current color block tables versus including the information in the notes section.

Key updates to the schedule included a change in wording for the definition of the red bars on the table to include “not recommended or contraindicated” instead of only the word “contraindicated.” Committee members were especially interested in changing this wording to guide clinicians in use of the live attenuated influenza vaccine because of its potential value in vaccinating health care personnel.

Other updates include language that vaccination of adolescents and young adults aged 16-23 years who are not at increased risk for meningococcal disease should be vaccinated as follows: “Based on shared clinical decision making, 2-dose series MenB-4C at least 1 month apart or 2-dose series MenB-FHbp at 0, 6 months.”

Similarly, clinical decision-making language was added to the notes for the pneumococcal polysaccharide vaccine (PPSV23) and the 13-valent pneumococcal conjugate vaccine (PCV13).

The routine vaccination calls for only one dose of PPSV23 given on or after the individual’s 65th birthday. Then, based on shared clinical decision making, a dose of PCV13 is recommended for immunocompetent individuals aged 65 years and older. The notes also state that, based on shared clinical decision making, PCV13 and PPSV23 should not be given in the same visit and, if both will be given, PCV13 should be first and should be given 1 year before PPSV23. In addition, “PPSV23 should be given at least 5 years after any previous PPSV23 dose.”

The schedule also adds shared clinical decision making to the notes on human papillomavirus vaccination for adults aged 27-45 years.

The committee members acknowledged the increasing complexity of the adult vaccination schedule, but several members agreed that it is accessible to many clinicians.

“We can’t let the perfect be the enemy of the good” said Jason Goldman, MD, liaison representing the American College of Physicians. “Those who want to learn the schedule will learn it; the health system will learn it,” even if not every specialist does.

The table “is something to draw you in,” said Sandra Fryhofer, MD, an internist who is liaison for the American Medical Association. The notes provide more details.

More specific information about contraindications for patients with cochlear implants, which also came up in the discussion, may be added to the schedule at a later date.

View the current adult vaccination schedule here.

The ACIP members had no financial conflicts to disclose.
 

The Food and Drug Administration has approved elexacaftor/ivacaftor/tezacaftor (Trikafta) for the treatment of the most common type of cystic fibrosis in patients aged 12 years or older, the first triple-combination therapy approved for that indication.

Olivier Le Moal/Getty Images

Approval for Trikafta was based on results from two clinical trials in patients with cystic fibrosis with an F508del mutation in the cystic fibrosis transmembrane conductance regulator (CFTR) gene. In the first trial, a 24-week, randomized, double-blind, placebo-controlled study of 403 patients, the mean percent predicted forced expiratory volume in 1 second increased by 14% from baseline, compared with placebo. In the second trial, a 4-week, randomized, double-blind, active-controlled study of 107 patients, mean percent predicted forced expiratory volume in 1 second was increased 10% from baseline, compared with tezacaftor/ivacaftor, according to the FDA press release.

In the first trial, patients who received Trikafta also saw improvement in sweat chloride, reduction in the number of pulmonary exacerbations, and reduction of body mass index, compared with placebo.

The most common adverse events associated with Trikafta during the trials were headaches, upper respiratory tract infections, abdominal pains, diarrhea, rashes, and rhinorrhea, among others. The label includes a warning related to elevated liver function tests, use at the same time with products that induce or inhibit a liver enzyme called cytochrome P450 3A4, and cataract risk.

“At the FDA, we’re consistently looking for ways to help speed the development of new therapies for complex diseases, while maintaining our high standards of review. Today’s landmark approval is a testament to these efforts, making a novel treatment available to most cystic fibrosis patients, including adolescents, who previously had no options and giving others in the cystic fibrosis community access to an additional effective therapy,” said acting FDA Commissioner Ned Sharpless, MD.

Find the full press release on the FDA website.

[email protected]

The Food and Drug Administration has approved elexacaftor/ivacaftor/tezacaftor (Trikafta) for the treatment of the most common type of cystic fibrosis in patients aged 12 years or older, the first triple-combination therapy approved for that indication.

Olivier Le Moal/Getty Images

Approval for Trikafta was based on results from two clinical trials in patients with cystic fibrosis with an F508del mutation in the cystic fibrosis transmembrane conductance regulator (CFTR) gene. In the first trial, a 24-week, randomized, double-blind, placebo-controlled study of 403 patients, the mean percent predicted forced expiratory volume in 1 second increased by 14% from baseline, compared with placebo. In the second trial, a 4-week, randomized, double-blind, active-controlled study of 107 patients, mean percent predicted forced expiratory volume in 1 second was increased 10% from baseline, compared with tezacaftor/ivacaftor, according to the FDA press release.

In the first trial, patients who received Trikafta also saw improvement in sweat chloride, reduction in the number of pulmonary exacerbations, and reduction of body mass index, compared with placebo.

The most common adverse events associated with Trikafta during the trials were headaches, upper respiratory tract infections, abdominal pains, diarrhea, rashes, and rhinorrhea, among others. The label includes a warning related to elevated liver function tests, use at the same time with products that induce or inhibit a liver enzyme called cytochrome P450 3A4, and cataract risk.

“At the FDA, we’re consistently looking for ways to help speed the development of new therapies for complex diseases, while maintaining our high standards of review. Today’s landmark approval is a testament to these efforts, making a novel treatment available to most cystic fibrosis patients, including adolescents, who previously had no options and giving others in the cystic fibrosis community access to an additional effective therapy,” said acting FDA Commissioner Ned Sharpless, MD.

Find the full press release on the FDA website.

[email protected]

The Food and Drug Administration has approved elexacaftor/ivacaftor/tezacaftor (Trikafta) for the treatment of the most common type of cystic fibrosis in patients aged 12 years or older, the first triple-combination therapy approved for that indication.

Olivier Le Moal/Getty Images

Approval for Trikafta was based on results from two clinical trials in patients with cystic fibrosis with an F508del mutation in the cystic fibrosis transmembrane conductance regulator (CFTR) gene. In the first trial, a 24-week, randomized, double-blind, placebo-controlled study of 403 patients, the mean percent predicted forced expiratory volume in 1 second increased by 14% from baseline, compared with placebo. In the second trial, a 4-week, randomized, double-blind, active-controlled study of 107 patients, mean percent predicted forced expiratory volume in 1 second was increased 10% from baseline, compared with tezacaftor/ivacaftor, according to the FDA press release.

In the first trial, patients who received Trikafta also saw improvement in sweat chloride, reduction in the number of pulmonary exacerbations, and reduction of body mass index, compared with placebo.

The most common adverse events associated with Trikafta during the trials were headaches, upper respiratory tract infections, abdominal pains, diarrhea, rashes, and rhinorrhea, among others. The label includes a warning related to elevated liver function tests, use at the same time with products that induce or inhibit a liver enzyme called cytochrome P450 3A4, and cataract risk.

“At the FDA, we’re consistently looking for ways to help speed the development of new therapies for complex diseases, while maintaining our high standards of review. Today’s landmark approval is a testament to these efforts, making a novel treatment available to most cystic fibrosis patients, including adolescents, who previously had no options and giving others in the cystic fibrosis community access to an additional effective therapy,” said acting FDA Commissioner Ned Sharpless, MD.

Find the full press release on the FDA website.

[email protected]