Pulmonary Health Hub

BOSTON – Between 15% and 30% of children with moderate to severe atopic dermatitis also have food allergies, but the allergies are a trigger for AD in only a small subset of patients, according to Mercedes E. Gonzalez, MD.

In most cases, allergy testing is not indicated, she said at the American Academy of Dermatology summer meeting.

©Julián Rovagnati/Fotolia.com

She described a scenario involving a parent who is concerned that a food allergy is causing her child’s AD. The child has had no hives, no lip swelling, and no other signs of immediate hypersensitivity. In such a case, the best approach is to treat with topical therapies and follow the patient clinically.

“Allergy testing independent of history is not recommended,” she said.

However, in cases involving a significant concern about food allergy, such as the presence of hives or urticaria, or when the child has severe dermatitis that is not improving with optimized topical therapies, an assessment can be undertaken, said Dr. Gonzalez of the University of Miami.

She recommended limited food allergy testing – for common culprits such as cow’s milk, eggs, wheat, soy, and peanuts – in children younger than age 5 years with moderate to severe AD, if the AD persists despite optimized topical treatment and/or a history of immediate and reproducible reaction after ingestion of a specific food.

Food elimination diets based solely on the findings of food allergy test results are not recommended for managing AD, she noted.

If a patient has true immunoglobulin E–mediated allergy they should practice avoidance to prevent potential serious health sequelae, Dr. Gonzalez said.

When testing is done, keep in mind that skin prick tests and serum-specific IgE levels have high negative predictive values above 95%, but low specificity and positive predictive values of 40%-60%, she pointed out. Positive tests should be verified with a food elimination diet or oral food challenge.

Also, most children develop tolerance to the foods over time and should be retested, Dr. Gonzalez said.

Early peanut introduction advised in infants with AD

There is no need to delay the introduction of peanuts into the diet of an infant at high risk for atopic dermatitis, Dr. Gonzalez said.

A 2015 consensus communication from the American Academy of Pediatrics and numerous other organizations, including the American Academy of Allergy, Asthma & Immunology and the Society of Pediatric Dermatology, offering interim guidance on the topic calls for introduction of peanut products into the diets of high-risk infants in countries where peanut allergy is present, she said.

High-risk infants were defined in the study as those with egg allergy and/or severe eczema.

The guidance, which the AAP “endorses and accepts as its policy” pending more formal guidelines currently in development, was based largely on findings from the LEAP (Learn Early About Peanut Allergy) trial – a 5-year randomized, controlled trial of 640 high-risk infants aged 4-11 months. The trial showed that 17.2% of infants who avoided peanuts had peanut allergy at 5 years, compared with 3.2% of those with peanut consumption three times weekly, a relative risk reduction of 81% (N Engl J Med. 2015; 372:803-13).

In infants with egg allergy or severe eczema, an evaluation by an allergist or dermatologist familiar with the guidance may be warranted to assist in implementing the suggestions, Dr. Gonzalez said.

Dr. Gonzalez reported receiving honoraria for serving as a speaker and/or advisory board member for Pierre Fabre Dermatologie, Anacor Pharmaceuticals, Encore Dermatology, and PuraCap Pharmaceutical.

[email protected]

BOSTON – Between 15% and 30% of children with moderate to severe atopic dermatitis also have food allergies, but the allergies are a trigger for AD in only a small subset of patients, according to Mercedes E. Gonzalez, MD.

In most cases, allergy testing is not indicated, she said at the American Academy of Dermatology summer meeting.

©Julián Rovagnati/Fotolia.com

She described a scenario involving a parent who is concerned that a food allergy is causing her child’s AD. The child has had no hives, no lip swelling, and no other signs of immediate hypersensitivity. In such a case, the best approach is to treat with topical therapies and follow the patient clinically.

“Allergy testing independent of history is not recommended,” she said.

However, in cases involving a significant concern about food allergy, such as the presence of hives or urticaria, or when the child has severe dermatitis that is not improving with optimized topical therapies, an assessment can be undertaken, said Dr. Gonzalez of the University of Miami.

She recommended limited food allergy testing – for common culprits such as cow’s milk, eggs, wheat, soy, and peanuts – in children younger than age 5 years with moderate to severe AD, if the AD persists despite optimized topical treatment and/or a history of immediate and reproducible reaction after ingestion of a specific food.

Food elimination diets based solely on the findings of food allergy test results are not recommended for managing AD, she noted.

If a patient has true immunoglobulin E–mediated allergy they should practice avoidance to prevent potential serious health sequelae, Dr. Gonzalez said.

When testing is done, keep in mind that skin prick tests and serum-specific IgE levels have high negative predictive values above 95%, but low specificity and positive predictive values of 40%-60%, she pointed out. Positive tests should be verified with a food elimination diet or oral food challenge.

Also, most children develop tolerance to the foods over time and should be retested, Dr. Gonzalez said.

Early peanut introduction advised in infants with AD

There is no need to delay the introduction of peanuts into the diet of an infant at high risk for atopic dermatitis, Dr. Gonzalez said.

A 2015 consensus communication from the American Academy of Pediatrics and numerous other organizations, including the American Academy of Allergy, Asthma & Immunology and the Society of Pediatric Dermatology, offering interim guidance on the topic calls for introduction of peanut products into the diets of high-risk infants in countries where peanut allergy is present, she said.

High-risk infants were defined in the study as those with egg allergy and/or severe eczema.

The guidance, which the AAP “endorses and accepts as its policy” pending more formal guidelines currently in development, was based largely on findings from the LEAP (Learn Early About Peanut Allergy) trial – a 5-year randomized, controlled trial of 640 high-risk infants aged 4-11 months. The trial showed that 17.2% of infants who avoided peanuts had peanut allergy at 5 years, compared with 3.2% of those with peanut consumption three times weekly, a relative risk reduction of 81% (N Engl J Med. 2015; 372:803-13).

In infants with egg allergy or severe eczema, an evaluation by an allergist or dermatologist familiar with the guidance may be warranted to assist in implementing the suggestions, Dr. Gonzalez said.

Dr. Gonzalez reported receiving honoraria for serving as a speaker and/or advisory board member for Pierre Fabre Dermatologie, Anacor Pharmaceuticals, Encore Dermatology, and PuraCap Pharmaceutical.

[email protected]

BOSTON – Between 15% and 30% of children with moderate to severe atopic dermatitis also have food allergies, but the allergies are a trigger for AD in only a small subset of patients, according to Mercedes E. Gonzalez, MD.

In most cases, allergy testing is not indicated, she said at the American Academy of Dermatology summer meeting.

©Julián Rovagnati/Fotolia.com

She described a scenario involving a parent who is concerned that a food allergy is causing her child’s AD. The child has had no hives, no lip swelling, and no other signs of immediate hypersensitivity. In such a case, the best approach is to treat with topical therapies and follow the patient clinically.

“Allergy testing independent of history is not recommended,” she said.

However, in cases involving a significant concern about food allergy, such as the presence of hives or urticaria, or when the child has severe dermatitis that is not improving with optimized topical therapies, an assessment can be undertaken, said Dr. Gonzalez of the University of Miami.

She recommended limited food allergy testing – for common culprits such as cow’s milk, eggs, wheat, soy, and peanuts – in children younger than age 5 years with moderate to severe AD, if the AD persists despite optimized topical treatment and/or a history of immediate and reproducible reaction after ingestion of a specific food.

Food elimination diets based solely on the findings of food allergy test results are not recommended for managing AD, she noted.

If a patient has true immunoglobulin E–mediated allergy they should practice avoidance to prevent potential serious health sequelae, Dr. Gonzalez said.

When testing is done, keep in mind that skin prick tests and serum-specific IgE levels have high negative predictive values above 95%, but low specificity and positive predictive values of 40%-60%, she pointed out. Positive tests should be verified with a food elimination diet or oral food challenge.

Also, most children develop tolerance to the foods over time and should be retested, Dr. Gonzalez said.

Early peanut introduction advised in infants with AD

There is no need to delay the introduction of peanuts into the diet of an infant at high risk for atopic dermatitis, Dr. Gonzalez said.

A 2015 consensus communication from the American Academy of Pediatrics and numerous other organizations, including the American Academy of Allergy, Asthma & Immunology and the Society of Pediatric Dermatology, offering interim guidance on the topic calls for introduction of peanut products into the diets of high-risk infants in countries where peanut allergy is present, she said.

High-risk infants were defined in the study as those with egg allergy and/or severe eczema.

The guidance, which the AAP “endorses and accepts as its policy” pending more formal guidelines currently in development, was based largely on findings from the LEAP (Learn Early About Peanut Allergy) trial – a 5-year randomized, controlled trial of 640 high-risk infants aged 4-11 months. The trial showed that 17.2% of infants who avoided peanuts had peanut allergy at 5 years, compared with 3.2% of those with peanut consumption three times weekly, a relative risk reduction of 81% (N Engl J Med. 2015; 372:803-13).

In infants with egg allergy or severe eczema, an evaluation by an allergist or dermatologist familiar with the guidance may be warranted to assist in implementing the suggestions, Dr. Gonzalez said.

Dr. Gonzalez reported receiving honoraria for serving as a speaker and/or advisory board member for Pierre Fabre Dermatologie, Anacor Pharmaceuticals, Encore Dermatology, and PuraCap Pharmaceutical.

[email protected]

SAN DIEGO – A sleep specialist told an audience of diabetes educators that quality sleep is “profoundly important” to the health of their patients, and regularly sleeping fewer than 7 hours a night can wreak havoc on glucose levels and insulin resistance.

There’s even evidence of a link between lack of sleep, diabetes, and heart disease, according to Terese C. Hammond, MD, medical director of the Keck Hospital of the University of Southern California Sleep Disorders Center in Los Angeles. “We don’t know which way the cause goes, but we know there’s a connection,” she said.

© YinYang/iStockphoto.com

Dr. Hammond, who spoke at the annual meeting of the American Association of Diabetes Educators, noted that the vast majority of adults need 7-9 hours of sleep a night.

If you repeatedly don’t reach 7 hours, “there is ample evidence that some metabolic and biologic things happen to your body. Glucose goes up and insulin is secreted. Leptin decreases – the protein that tells us when we’re sated, when our hunger is satisfied. It’s a pretty potent combination, and this is associated with increases in weight and carbohydrate intake,” Dr. Hammond said.

Indeed, findings from one small study suggest a link between chronic insufficient sleep to consumption of more calories, mostly carbohydrates. The study authors speculated this may be because people eat extra food to account for being awake more but take in more than they need (Proc Natl Acad Sci USA. 2013 Apr;110[14]:5695-700).

It is possible for people to pay off a “sleep debt” by catching up on sleep, Dr. Hammond said, but only if the sleep is lost temporarily, as during a heavy medical rotation or after a personal tragedy. When sleep loss is chronic, she said, “it’s becoming apparent that the end-organ consequences are not fully recoverable.”

In regard to diabetes specifically, she said, research has linked insufficient sleep to higher rates of central obesity, higher rates of diabetes in blacks and whites, impaired glucose tolerance, decreased insulin, metabolic syndrome, and high lipids. Too much sleep has also been linked to poor health outcomes.

How can medical professionals help patients improve sleep? “The most important thing to remember about sleep is that it’s a very primitive process,” according to Dr. Hammond. “You can’t think yourself into better sleep. You have to act yourself into better sleep through light, temperature, sound, and repetitive behaviors.”

Controversial research has linked sleeping pills to higher mortality rates, she says.“I try to avoid them long term for insomnia, and not only because there’s probably an increased risk. They stop working eventually.”

Another approach, cognitive behavioral therapy (CBT), is “the most potent way to change behavior,” she said.

“CBT improves sleep efficiency in a vast majority of chronic medical diseases,” she said. “It does just as well as drugs and better than most sleeping pills.”

According to Dr. Hammond, CBT focuses on several strategies:

• Education about sleep hygiene, such as limiting the bedroom to nighttime sleep and intimacy, going to bed at the same time every night, and focusing on a dark, cool, quiet environment.

• Increasing the “sleep drive” through temporary sleep deprivation.

• Relaxation training through techniques like guided imagery, biofeedback, progressive muscle relaxation, and self-hypnosis.

Dr. Hammond reported having no relevant financial disclosures.

SAN DIEGO – A sleep specialist told an audience of diabetes educators that quality sleep is “profoundly important” to the health of their patients, and regularly sleeping fewer than 7 hours a night can wreak havoc on glucose levels and insulin resistance.

There’s even evidence of a link between lack of sleep, diabetes, and heart disease, according to Terese C. Hammond, MD, medical director of the Keck Hospital of the University of Southern California Sleep Disorders Center in Los Angeles. “We don’t know which way the cause goes, but we know there’s a connection,” she said.

© YinYang/iStockphoto.com

Dr. Hammond, who spoke at the annual meeting of the American Association of Diabetes Educators, noted that the vast majority of adults need 7-9 hours of sleep a night.

If you repeatedly don’t reach 7 hours, “there is ample evidence that some metabolic and biologic things happen to your body. Glucose goes up and insulin is secreted. Leptin decreases – the protein that tells us when we’re sated, when our hunger is satisfied. It’s a pretty potent combination, and this is associated with increases in weight and carbohydrate intake,” Dr. Hammond said.

Indeed, findings from one small study suggest a link between chronic insufficient sleep to consumption of more calories, mostly carbohydrates. The study authors speculated this may be because people eat extra food to account for being awake more but take in more than they need (Proc Natl Acad Sci USA. 2013 Apr;110[14]:5695-700).

It is possible for people to pay off a “sleep debt” by catching up on sleep, Dr. Hammond said, but only if the sleep is lost temporarily, as during a heavy medical rotation or after a personal tragedy. When sleep loss is chronic, she said, “it’s becoming apparent that the end-organ consequences are not fully recoverable.”

In regard to diabetes specifically, she said, research has linked insufficient sleep to higher rates of central obesity, higher rates of diabetes in blacks and whites, impaired glucose tolerance, decreased insulin, metabolic syndrome, and high lipids. Too much sleep has also been linked to poor health outcomes.

How can medical professionals help patients improve sleep? “The most important thing to remember about sleep is that it’s a very primitive process,” according to Dr. Hammond. “You can’t think yourself into better sleep. You have to act yourself into better sleep through light, temperature, sound, and repetitive behaviors.”

Controversial research has linked sleeping pills to higher mortality rates, she says.“I try to avoid them long term for insomnia, and not only because there’s probably an increased risk. They stop working eventually.”

Another approach, cognitive behavioral therapy (CBT), is “the most potent way to change behavior,” she said.

“CBT improves sleep efficiency in a vast majority of chronic medical diseases,” she said. “It does just as well as drugs and better than most sleeping pills.”

According to Dr. Hammond, CBT focuses on several strategies:

• Education about sleep hygiene, such as limiting the bedroom to nighttime sleep and intimacy, going to bed at the same time every night, and focusing on a dark, cool, quiet environment.

• Increasing the “sleep drive” through temporary sleep deprivation.

• Relaxation training through techniques like guided imagery, biofeedback, progressive muscle relaxation, and self-hypnosis.

Dr. Hammond reported having no relevant financial disclosures.

SAN DIEGO – A sleep specialist told an audience of diabetes educators that quality sleep is “profoundly important” to the health of their patients, and regularly sleeping fewer than 7 hours a night can wreak havoc on glucose levels and insulin resistance.

There’s even evidence of a link between lack of sleep, diabetes, and heart disease, according to Terese C. Hammond, MD, medical director of the Keck Hospital of the University of Southern California Sleep Disorders Center in Los Angeles. “We don’t know which way the cause goes, but we know there’s a connection,” she said.

© YinYang/iStockphoto.com

Dr. Hammond, who spoke at the annual meeting of the American Association of Diabetes Educators, noted that the vast majority of adults need 7-9 hours of sleep a night.

If you repeatedly don’t reach 7 hours, “there is ample evidence that some metabolic and biologic things happen to your body. Glucose goes up and insulin is secreted. Leptin decreases – the protein that tells us when we’re sated, when our hunger is satisfied. It’s a pretty potent combination, and this is associated with increases in weight and carbohydrate intake,” Dr. Hammond said.

Indeed, findings from one small study suggest a link between chronic insufficient sleep to consumption of more calories, mostly carbohydrates. The study authors speculated this may be because people eat extra food to account for being awake more but take in more than they need (Proc Natl Acad Sci USA. 2013 Apr;110[14]:5695-700).

It is possible for people to pay off a “sleep debt” by catching up on sleep, Dr. Hammond said, but only if the sleep is lost temporarily, as during a heavy medical rotation or after a personal tragedy. When sleep loss is chronic, she said, “it’s becoming apparent that the end-organ consequences are not fully recoverable.”

In regard to diabetes specifically, she said, research has linked insufficient sleep to higher rates of central obesity, higher rates of diabetes in blacks and whites, impaired glucose tolerance, decreased insulin, metabolic syndrome, and high lipids. Too much sleep has also been linked to poor health outcomes.

How can medical professionals help patients improve sleep? “The most important thing to remember about sleep is that it’s a very primitive process,” according to Dr. Hammond. “You can’t think yourself into better sleep. You have to act yourself into better sleep through light, temperature, sound, and repetitive behaviors.”

Controversial research has linked sleeping pills to higher mortality rates, she says.“I try to avoid them long term for insomnia, and not only because there’s probably an increased risk. They stop working eventually.”

Another approach, cognitive behavioral therapy (CBT), is “the most potent way to change behavior,” she said.

“CBT improves sleep efficiency in a vast majority of chronic medical diseases,” she said. “It does just as well as drugs and better than most sleeping pills.”

According to Dr. Hammond, CBT focuses on several strategies:

• Education about sleep hygiene, such as limiting the bedroom to nighttime sleep and intimacy, going to bed at the same time every night, and focusing on a dark, cool, quiet environment.

• Increasing the “sleep drive” through temporary sleep deprivation.

• Relaxation training through techniques like guided imagery, biofeedback, progressive muscle relaxation, and self-hypnosis.

Dr. Hammond reported having no relevant financial disclosures.

A majority of pertussis cases in the United States may go undetected in people under the age of 50, particularly in adults, results of a retrospective database cohort study suggest.

“The incidence of pertussis in adolescents and adults is very difficult to quantify,” wrote Chi-Chang Chen, MD, of IMS Health, Plymouth Meeting, Pa., and associates. Symptoms may be misdiagnosed as other respiratory illnesses, infected individuals may not seek treatment, and pertussis may not be considered as a possible diagnosis in adults, they noted.

©Jacopo Werther/Wikimedia Commons/Creative Commons Attribution 2.0

To project the possible range of pertussis incidence in this population, the investigator used three different models to analyze information from private insurance and laboratory databases as well as data from the Centers for Disease Control and Prevention for a 6-year period. The first method, which used medical claims for ICD-9 diagnosed pertussis, found an annual incidence rate of 9/100,000 population. The second used a proxy pertussis model that was based on symptoms that could indicate undiagnosed pertussis, showing an incidence rate of 21/100,000. The third method used pathogen data to estimate the fraction of cough illness statistically attributable to pertussis, resulting in an incidence rate of 649/100,000 population, which is 58-93 times higher than the ICD-9 estimated incidence.

These estimates “highlight the need for improved preventive measures – such as increased vaccination – against pertussis,” the investigators said, noting that immunization recommendations for additional age groups and research involving strategies to reduce waning immunity after vaccination should be considered.

The study was funded by GlaxoSmithKline Vaccines.

Read the full study in Human Vaccines & Immunotherapeutics (2016 May. doi: 10.1080/21645515.2016.1186313).

[email protected]

A majority of pertussis cases in the United States may go undetected in people under the age of 50, particularly in adults, results of a retrospective database cohort study suggest.

“The incidence of pertussis in adolescents and adults is very difficult to quantify,” wrote Chi-Chang Chen, MD, of IMS Health, Plymouth Meeting, Pa., and associates. Symptoms may be misdiagnosed as other respiratory illnesses, infected individuals may not seek treatment, and pertussis may not be considered as a possible diagnosis in adults, they noted.

©Jacopo Werther/Wikimedia Commons/Creative Commons Attribution 2.0

To project the possible range of pertussis incidence in this population, the investigator used three different models to analyze information from private insurance and laboratory databases as well as data from the Centers for Disease Control and Prevention for a 6-year period. The first method, which used medical claims for ICD-9 diagnosed pertussis, found an annual incidence rate of 9/100,000 population. The second used a proxy pertussis model that was based on symptoms that could indicate undiagnosed pertussis, showing an incidence rate of 21/100,000. The third method used pathogen data to estimate the fraction of cough illness statistically attributable to pertussis, resulting in an incidence rate of 649/100,000 population, which is 58-93 times higher than the ICD-9 estimated incidence.

These estimates “highlight the need for improved preventive measures – such as increased vaccination – against pertussis,” the investigators said, noting that immunization recommendations for additional age groups and research involving strategies to reduce waning immunity after vaccination should be considered.

The study was funded by GlaxoSmithKline Vaccines.

Read the full study in Human Vaccines & Immunotherapeutics (2016 May. doi: 10.1080/21645515.2016.1186313).

[email protected]

A majority of pertussis cases in the United States may go undetected in people under the age of 50, particularly in adults, results of a retrospective database cohort study suggest.

“The incidence of pertussis in adolescents and adults is very difficult to quantify,” wrote Chi-Chang Chen, MD, of IMS Health, Plymouth Meeting, Pa., and associates. Symptoms may be misdiagnosed as other respiratory illnesses, infected individuals may not seek treatment, and pertussis may not be considered as a possible diagnosis in adults, they noted.

©Jacopo Werther/Wikimedia Commons/Creative Commons Attribution 2.0

To project the possible range of pertussis incidence in this population, the investigator used three different models to analyze information from private insurance and laboratory databases as well as data from the Centers for Disease Control and Prevention for a 6-year period. The first method, which used medical claims for ICD-9 diagnosed pertussis, found an annual incidence rate of 9/100,000 population. The second used a proxy pertussis model that was based on symptoms that could indicate undiagnosed pertussis, showing an incidence rate of 21/100,000. The third method used pathogen data to estimate the fraction of cough illness statistically attributable to pertussis, resulting in an incidence rate of 649/100,000 population, which is 58-93 times higher than the ICD-9 estimated incidence.

These estimates “highlight the need for improved preventive measures – such as increased vaccination – against pertussis,” the investigators said, noting that immunization recommendations for additional age groups and research involving strategies to reduce waning immunity after vaccination should be considered.

The study was funded by GlaxoSmithKline Vaccines.

Read the full study in Human Vaccines & Immunotherapeutics (2016 May. doi: 10.1080/21645515.2016.1186313).

[email protected]

A 66-year-old woman presents as a new patient for a clinic visit. She has a history of Guillain-Barré syndrome 10 years ago. The last immunization she received was a tetanus-diphtheria 12 years ago.

What do you recommend for her to receive over the next year?

A. Pneumococcal 13/Pneumococcal 23/Tdap/influenza vaccines.

B. Pneumococcal 13/Pneumococcal 23/Tdap vaccines.

C. Influenza vaccine.

D. No vaccines.

Guillain-Barré syndrome (GBS) is a rare, acute, immune-mediated polyneuropathy that has an incidence of about 2 cases per 100,000 people each year.¹ Most cases of GBS follow an infectious event (usually an upper respiratory infection or gastrointestinal infection). In 1976, administration of the swine flu vaccine was associated with an up to eightfold increased risk of GBS.^2,3 Many patients who have had GBS have been advised not to – or are fearful to – receive influenza vaccine or any vaccine.

Is there good evidence for patients with a history of GBS to avoid influenza vaccines or vaccinations in general?

The initial concern over the increased risk of GBS following the large-scale influenza vaccination in 1976 has not been realized with subsequent influenza vaccines. In a study by Baxter and colleagues, GBS cases from Kaiser Permanente Northern California from 1995 to 2006 were reviewed.⁴ They looked at whether patients had received influenza vaccine in the 6 weeks prior to GBS, compared with vaccination within the prior 9 months.

The odds ratio for influenza vaccination in the 6 weeks prior to GBS was 1.1 (95% confidence interval, 0.4-3.1). The odds ratio for receiving tetanus diphtheria vaccine in the 6 weeks prior to GBS was 1.4 (95% CI, 0.3-4.5); pneumococcal 23 vaccine, 0.7 (95% CI, 0.1-2.9); and all vaccines combined, 1.3 (95% CI, 0.8-2.3).

Shahed Iqbal, MBBS, et al. looked at the relationship between influenza illness, pneumonia, influenza vaccination, and GBS.⁵ They found that although influenza vaccine coverage increased from 20% to 36% over the study period, there was not an increase in GBS hospitalizations over the same period. There was a significant correlation between hospitalizations for pneumonia and influenza and GBS hospitalizations in the same month.

In a simulation study, Steven Hawken, PhD, and his colleagues concluded that under typical conditions (influenza incidence greater than 5% and vaccine effectiveness greater than 60%), influenza vaccination reduced GBS risk.⁶

There are fewer data on vaccination in patients who have previously had GBS, but there is enough evidence to help guide us.

Roger Baxter, MD, and colleagues, using the database in reference 4, looked at outcome of patients with GBS who received vaccinations subsequent to recovery from GBS.⁷ A total of 279 patient with previous GBS received a total of 989 vaccinations, including 405 trivalent influenza vaccinations. None of the patients with GBS who received vaccinations had a recurrence of GBS.

Krista Kuitwaard, MD, et al. reported identical findings in a survey of patients with a history of GBS or chronic inflammatory demyelinating polyradiculoneuropathy (CIDP).⁸ A total of 245 patients with GBS responded to the survey. A total of 106 GBS patients had received influenza vaccine following their GBS diagnosis (a total of 775 vaccinations in those patients). None of the patients with a history of GBS who received influenza vaccination had a recurrence of their GBS.

The current position of the GBS/CIDP Foundation on vaccination for patients with GBS is as follows: The GBS/CIDP Foundation recommends avoiding immunizations that a GBS patient had received within 6 weeks of developing their initial symptoms.⁹

I think the current evidence is enough to guide us in this issue. Vaccinations, including influenza vaccine, are likely safe for patients with a history of GBS. The recommendation of the GBS/CIDP foundation is reasonable – to avoid immunizations that appeared to have potentially triggered the initial GBS (ones that had been received within 6 weeks of onset of symptoms).

In the case presented above, I think that choice A – receiving all the recommended immunizations – would be appropriate.

References

1. Neuroepidemiology 2011; 36(2):123-33.

2. Am J Epidemiol. 1979 Aug;110(2):105-23.

3. Clin Infect Dis. 2014 Apr;58(8):1149-55.

4. Clin Infect Dis. 2013 Jul;57(2):197-204.

5. Vaccine. 2015 Apr 21;33(17):2045-9.

6. Emerg Infect Dis. 2015 Feb;21(2):224-31.

7. Clin Infect Dis. 2012 Mar;54(6):800-4.

8. J Peripher Nerv Syst. 2009 Dec;14(4):310-5.

9. GBS/CIDP Foundation International, Position on Flu Shots and Vaccinations.

Dr. Paauw is professor of medicine in the division of general internal medicine at the University of Washington, Seattle, and he serves as third-year medical student clerkship director at the University of Washington. Contact Dr. Paauw at [email protected].

A 66-year-old woman presents as a new patient for a clinic visit. She has a history of Guillain-Barré syndrome 10 years ago. The last immunization she received was a tetanus-diphtheria 12 years ago.

What do you recommend for her to receive over the next year?

A. Pneumococcal 13/Pneumococcal 23/Tdap/influenza vaccines.

B. Pneumococcal 13/Pneumococcal 23/Tdap vaccines.

C. Influenza vaccine.

D. No vaccines.

Guillain-Barré syndrome (GBS) is a rare, acute, immune-mediated polyneuropathy that has an incidence of about 2 cases per 100,000 people each year.¹ Most cases of GBS follow an infectious event (usually an upper respiratory infection or gastrointestinal infection). In 1976, administration of the swine flu vaccine was associated with an up to eightfold increased risk of GBS.^2,3 Many patients who have had GBS have been advised not to – or are fearful to – receive influenza vaccine or any vaccine.

Is there good evidence for patients with a history of GBS to avoid influenza vaccines or vaccinations in general?

The initial concern over the increased risk of GBS following the large-scale influenza vaccination in 1976 has not been realized with subsequent influenza vaccines. In a study by Baxter and colleagues, GBS cases from Kaiser Permanente Northern California from 1995 to 2006 were reviewed.⁴ They looked at whether patients had received influenza vaccine in the 6 weeks prior to GBS, compared with vaccination within the prior 9 months.

The odds ratio for influenza vaccination in the 6 weeks prior to GBS was 1.1 (95% confidence interval, 0.4-3.1). The odds ratio for receiving tetanus diphtheria vaccine in the 6 weeks prior to GBS was 1.4 (95% CI, 0.3-4.5); pneumococcal 23 vaccine, 0.7 (95% CI, 0.1-2.9); and all vaccines combined, 1.3 (95% CI, 0.8-2.3).

Shahed Iqbal, MBBS, et al. looked at the relationship between influenza illness, pneumonia, influenza vaccination, and GBS.⁵ They found that although influenza vaccine coverage increased from 20% to 36% over the study period, there was not an increase in GBS hospitalizations over the same period. There was a significant correlation between hospitalizations for pneumonia and influenza and GBS hospitalizations in the same month.

In a simulation study, Steven Hawken, PhD, and his colleagues concluded that under typical conditions (influenza incidence greater than 5% and vaccine effectiveness greater than 60%), influenza vaccination reduced GBS risk.⁶

There are fewer data on vaccination in patients who have previously had GBS, but there is enough evidence to help guide us.

Roger Baxter, MD, and colleagues, using the database in reference 4, looked at outcome of patients with GBS who received vaccinations subsequent to recovery from GBS.⁷ A total of 279 patient with previous GBS received a total of 989 vaccinations, including 405 trivalent influenza vaccinations. None of the patients with GBS who received vaccinations had a recurrence of GBS.

Krista Kuitwaard, MD, et al. reported identical findings in a survey of patients with a history of GBS or chronic inflammatory demyelinating polyradiculoneuropathy (CIDP).⁸ A total of 245 patients with GBS responded to the survey. A total of 106 GBS patients had received influenza vaccine following their GBS diagnosis (a total of 775 vaccinations in those patients). None of the patients with a history of GBS who received influenza vaccination had a recurrence of their GBS.

The current position of the GBS/CIDP Foundation on vaccination for patients with GBS is as follows: The GBS/CIDP Foundation recommends avoiding immunizations that a GBS patient had received within 6 weeks of developing their initial symptoms.⁹

I think the current evidence is enough to guide us in this issue. Vaccinations, including influenza vaccine, are likely safe for patients with a history of GBS. The recommendation of the GBS/CIDP foundation is reasonable – to avoid immunizations that appeared to have potentially triggered the initial GBS (ones that had been received within 6 weeks of onset of symptoms).

In the case presented above, I think that choice A – receiving all the recommended immunizations – would be appropriate.

References

1. Neuroepidemiology 2011; 36(2):123-33.

2. Am J Epidemiol. 1979 Aug;110(2):105-23.

3. Clin Infect Dis. 2014 Apr;58(8):1149-55.

4. Clin Infect Dis. 2013 Jul;57(2):197-204.

5. Vaccine. 2015 Apr 21;33(17):2045-9.

6. Emerg Infect Dis. 2015 Feb;21(2):224-31.

7. Clin Infect Dis. 2012 Mar;54(6):800-4.

8. J Peripher Nerv Syst. 2009 Dec;14(4):310-5.

9. GBS/CIDP Foundation International, Position on Flu Shots and Vaccinations.

Dr. Paauw is professor of medicine in the division of general internal medicine at the University of Washington, Seattle, and he serves as third-year medical student clerkship director at the University of Washington. Contact Dr. Paauw at [email protected].

A 66-year-old woman presents as a new patient for a clinic visit. She has a history of Guillain-Barré syndrome 10 years ago. The last immunization she received was a tetanus-diphtheria 12 years ago.

What do you recommend for her to receive over the next year?

A. Pneumococcal 13/Pneumococcal 23/Tdap/influenza vaccines.

B. Pneumococcal 13/Pneumococcal 23/Tdap vaccines.

C. Influenza vaccine.

D. No vaccines.

Guillain-Barré syndrome (GBS) is a rare, acute, immune-mediated polyneuropathy that has an incidence of about 2 cases per 100,000 people each year.¹ Most cases of GBS follow an infectious event (usually an upper respiratory infection or gastrointestinal infection). In 1976, administration of the swine flu vaccine was associated with an up to eightfold increased risk of GBS.^2,3 Many patients who have had GBS have been advised not to – or are fearful to – receive influenza vaccine or any vaccine.

Is there good evidence for patients with a history of GBS to avoid influenza vaccines or vaccinations in general?

The initial concern over the increased risk of GBS following the large-scale influenza vaccination in 1976 has not been realized with subsequent influenza vaccines. In a study by Baxter and colleagues, GBS cases from Kaiser Permanente Northern California from 1995 to 2006 were reviewed.⁴ They looked at whether patients had received influenza vaccine in the 6 weeks prior to GBS, compared with vaccination within the prior 9 months.

The odds ratio for influenza vaccination in the 6 weeks prior to GBS was 1.1 (95% confidence interval, 0.4-3.1). The odds ratio for receiving tetanus diphtheria vaccine in the 6 weeks prior to GBS was 1.4 (95% CI, 0.3-4.5); pneumococcal 23 vaccine, 0.7 (95% CI, 0.1-2.9); and all vaccines combined, 1.3 (95% CI, 0.8-2.3).

Shahed Iqbal, MBBS, et al. looked at the relationship between influenza illness, pneumonia, influenza vaccination, and GBS.⁵ They found that although influenza vaccine coverage increased from 20% to 36% over the study period, there was not an increase in GBS hospitalizations over the same period. There was a significant correlation between hospitalizations for pneumonia and influenza and GBS hospitalizations in the same month.

In a simulation study, Steven Hawken, PhD, and his colleagues concluded that under typical conditions (influenza incidence greater than 5% and vaccine effectiveness greater than 60%), influenza vaccination reduced GBS risk.⁶

There are fewer data on vaccination in patients who have previously had GBS, but there is enough evidence to help guide us.

Roger Baxter, MD, and colleagues, using the database in reference 4, looked at outcome of patients with GBS who received vaccinations subsequent to recovery from GBS.⁷ A total of 279 patient with previous GBS received a total of 989 vaccinations, including 405 trivalent influenza vaccinations. None of the patients with GBS who received vaccinations had a recurrence of GBS.

Krista Kuitwaard, MD, et al. reported identical findings in a survey of patients with a history of GBS or chronic inflammatory demyelinating polyradiculoneuropathy (CIDP).⁸ A total of 245 patients with GBS responded to the survey. A total of 106 GBS patients had received influenza vaccine following their GBS diagnosis (a total of 775 vaccinations in those patients). None of the patients with a history of GBS who received influenza vaccination had a recurrence of their GBS.

The current position of the GBS/CIDP Foundation on vaccination for patients with GBS is as follows: The GBS/CIDP Foundation recommends avoiding immunizations that a GBS patient had received within 6 weeks of developing their initial symptoms.⁹

I think the current evidence is enough to guide us in this issue. Vaccinations, including influenza vaccine, are likely safe for patients with a history of GBS. The recommendation of the GBS/CIDP foundation is reasonable – to avoid immunizations that appeared to have potentially triggered the initial GBS (ones that had been received within 6 weeks of onset of symptoms).

In the case presented above, I think that choice A – receiving all the recommended immunizations – would be appropriate.

References

1. Neuroepidemiology 2011; 36(2):123-33.

2. Am J Epidemiol. 1979 Aug;110(2):105-23.

3. Clin Infect Dis. 2014 Apr;58(8):1149-55.

4. Clin Infect Dis. 2013 Jul;57(2):197-204.

5. Vaccine. 2015 Apr 21;33(17):2045-9.

6. Emerg Infect Dis. 2015 Feb;21(2):224-31.

7. Clin Infect Dis. 2012 Mar;54(6):800-4.

8. J Peripher Nerv Syst. 2009 Dec;14(4):310-5.

9. GBS/CIDP Foundation International, Position on Flu Shots and Vaccinations.

Dr. Paauw is professor of medicine in the division of general internal medicine at the University of Washington, Seattle, and he serves as third-year medical student clerkship director at the University of Washington. Contact Dr. Paauw at [email protected].

As-needed use of acetaminophen for fever or pain does not exacerbate mild persistent asthma in young children, according to a report published online August 18 in the New England Journal of Medicine.

In a prospective, randomized, double-blind clinical trial performed at 18 U.S. medical centers, neither acetaminophen nor ibuprofen raised the rate of exacerbations or impaired asthma control among 300 children aged 1-5 years. This result refutes those of observational and post hoc data that linked acetaminophen to increased asthma exacerbations, daily symptoms, and need for bronchodilators in children and adults. Those findings “have led to much controversy and even alarm,” with some physicians recommending that acetaminophen be completely avoided in children with asthma until more safety data became available, said William J. Sheehan, MD, of the division of allergy and immunology, Boston Children’s Hospital and Harvard Medical School, Boston, and his associates.

©tupungato/Thinkstock.com

The investigators performed this 2-year study to obtain such safety data. The children (median age, 40 months) were randomly assigned to receive either liquid acetaminophen (150 patients) or matching liquid ibuprofen (150 patients) as needed for pain, fever, or discomfort and were followed for 46 weeks. All the participants received standard asthma-control therapies including inhaled glucocorticoids, oral leukotriene-receptor antagonists, and as-needed inhaled glucocorticoids.

The primary outcome – the mean number of asthma exacerbations – was 0.81 in the acetaminophen group and 0.87 in the ibuprofen group, a nonsignificant difference. The rate of exacerbations also did not differ between acetaminophen and ibuprofen in the subgroup of 226 children who completed the entire trial or in the subgroup of 200 who received a study medication for pain or fever at least once during follow-up, Dr. Sheehan and his associates said (N Engl J Med. 2016 Aug 18. doi: 10.1056/NEJMoa1515990).

There also were no significant differences between the two study groups in time to first asthma exacerbation, percentage of days of good asthma control (85.8% vs. 86.8% of days), use of rescue albuterol (2.8 vs. 3.0 inhalations per week), or unscheduled health care visits for asthma (0.75 vs. 0.76 visits). No between-group differences occurred regarding adverse events or serious adverse events.

Some experts have suggested that the observational studies reporting a link between acetaminophen and asthma exacerbations may have been flawed by “confounding by indication,” because children with asthma have more symptomatic respiratory infections than do those without asthma and use more acetaminophen for fever and malaise. “We [also] observed that greater use of antipyretic, analgesic medications was associated with more apparent respiratory illnesses and that the reported respiratory illnesses were associated with asthma exacerbations.

“However, we found no evidence that acetaminophen, when used during periods of respiratory illness, was associated with a higher risk of asthma exacerbations or other asthma-related complications than was ibuprofen,” Dr. Sheehan and his associates wrote.

This study was funded by the National Institutes of Health and the National Heart, Lung, and Blood Institute. Dr. Sheehan reported having no relevant financial disclosures; his associates reported numerous ties to industry sources.

As-needed use of acetaminophen for fever or pain does not exacerbate mild persistent asthma in young children, according to a report published online August 18 in the New England Journal of Medicine.

In a prospective, randomized, double-blind clinical trial performed at 18 U.S. medical centers, neither acetaminophen nor ibuprofen raised the rate of exacerbations or impaired asthma control among 300 children aged 1-5 years. This result refutes those of observational and post hoc data that linked acetaminophen to increased asthma exacerbations, daily symptoms, and need for bronchodilators in children and adults. Those findings “have led to much controversy and even alarm,” with some physicians recommending that acetaminophen be completely avoided in children with asthma until more safety data became available, said William J. Sheehan, MD, of the division of allergy and immunology, Boston Children’s Hospital and Harvard Medical School, Boston, and his associates.

©tupungato/Thinkstock.com

The investigators performed this 2-year study to obtain such safety data. The children (median age, 40 months) were randomly assigned to receive either liquid acetaminophen (150 patients) or matching liquid ibuprofen (150 patients) as needed for pain, fever, or discomfort and were followed for 46 weeks. All the participants received standard asthma-control therapies including inhaled glucocorticoids, oral leukotriene-receptor antagonists, and as-needed inhaled glucocorticoids.

The primary outcome – the mean number of asthma exacerbations – was 0.81 in the acetaminophen group and 0.87 in the ibuprofen group, a nonsignificant difference. The rate of exacerbations also did not differ between acetaminophen and ibuprofen in the subgroup of 226 children who completed the entire trial or in the subgroup of 200 who received a study medication for pain or fever at least once during follow-up, Dr. Sheehan and his associates said (N Engl J Med. 2016 Aug 18. doi: 10.1056/NEJMoa1515990).

There also were no significant differences between the two study groups in time to first asthma exacerbation, percentage of days of good asthma control (85.8% vs. 86.8% of days), use of rescue albuterol (2.8 vs. 3.0 inhalations per week), or unscheduled health care visits for asthma (0.75 vs. 0.76 visits). No between-group differences occurred regarding adverse events or serious adverse events.

Some experts have suggested that the observational studies reporting a link between acetaminophen and asthma exacerbations may have been flawed by “confounding by indication,” because children with asthma have more symptomatic respiratory infections than do those without asthma and use more acetaminophen for fever and malaise. “We [also] observed that greater use of antipyretic, analgesic medications was associated with more apparent respiratory illnesses and that the reported respiratory illnesses were associated with asthma exacerbations.

“However, we found no evidence that acetaminophen, when used during periods of respiratory illness, was associated with a higher risk of asthma exacerbations or other asthma-related complications than was ibuprofen,” Dr. Sheehan and his associates wrote.

This study was funded by the National Institutes of Health and the National Heart, Lung, and Blood Institute. Dr. Sheehan reported having no relevant financial disclosures; his associates reported numerous ties to industry sources.

As-needed use of acetaminophen for fever or pain does not exacerbate mild persistent asthma in young children, according to a report published online August 18 in the New England Journal of Medicine.

In a prospective, randomized, double-blind clinical trial performed at 18 U.S. medical centers, neither acetaminophen nor ibuprofen raised the rate of exacerbations or impaired asthma control among 300 children aged 1-5 years. This result refutes those of observational and post hoc data that linked acetaminophen to increased asthma exacerbations, daily symptoms, and need for bronchodilators in children and adults. Those findings “have led to much controversy and even alarm,” with some physicians recommending that acetaminophen be completely avoided in children with asthma until more safety data became available, said William J. Sheehan, MD, of the division of allergy and immunology, Boston Children’s Hospital and Harvard Medical School, Boston, and his associates.

©tupungato/Thinkstock.com

The investigators performed this 2-year study to obtain such safety data. The children (median age, 40 months) were randomly assigned to receive either liquid acetaminophen (150 patients) or matching liquid ibuprofen (150 patients) as needed for pain, fever, or discomfort and were followed for 46 weeks. All the participants received standard asthma-control therapies including inhaled glucocorticoids, oral leukotriene-receptor antagonists, and as-needed inhaled glucocorticoids.

The primary outcome – the mean number of asthma exacerbations – was 0.81 in the acetaminophen group and 0.87 in the ibuprofen group, a nonsignificant difference. The rate of exacerbations also did not differ between acetaminophen and ibuprofen in the subgroup of 226 children who completed the entire trial or in the subgroup of 200 who received a study medication for pain or fever at least once during follow-up, Dr. Sheehan and his associates said (N Engl J Med. 2016 Aug 18. doi: 10.1056/NEJMoa1515990).

There also were no significant differences between the two study groups in time to first asthma exacerbation, percentage of days of good asthma control (85.8% vs. 86.8% of days), use of rescue albuterol (2.8 vs. 3.0 inhalations per week), or unscheduled health care visits for asthma (0.75 vs. 0.76 visits). No between-group differences occurred regarding adverse events or serious adverse events.

Some experts have suggested that the observational studies reporting a link between acetaminophen and asthma exacerbations may have been flawed by “confounding by indication,” because children with asthma have more symptomatic respiratory infections than do those without asthma and use more acetaminophen for fever and malaise. “We [also] observed that greater use of antipyretic, analgesic medications was associated with more apparent respiratory illnesses and that the reported respiratory illnesses were associated with asthma exacerbations.

“However, we found no evidence that acetaminophen, when used during periods of respiratory illness, was associated with a higher risk of asthma exacerbations or other asthma-related complications than was ibuprofen,” Dr. Sheehan and his associates wrote.

This study was funded by the National Institutes of Health and the National Heart, Lung, and Blood Institute. Dr. Sheehan reported having no relevant financial disclosures; his associates reported numerous ties to industry sources.

Elementary school students had improved attitudes toward food allergies and felt more confident in taking action during a food allergy emergency after completing an education program on the subject, results of a pilot study in Japan suggest.

At present there is no standard school curriculum for children regarding food allergy, wrote Dr. Kiwako Yamamoto-Hanada of the National Center for Child Health and Development, Tokyo, and associates, so they developed such a program consisting of two 60-minute sessions. A total of 36 elementary school children, 8 of whom had a history of food allergies, filled out questionnaires before and after participating in the program.

After completing the program, 79% of the students stated that it should be included in the school curriculum. Students also demonstrated improved knowledge about food allergies, with a greater percentage knowing what an EpiPen is (100% vs. 0%), understanding that food allergy is related to death (100% vs. 43%), and feeling confident that they could take immediate action if they saw a food allergy emergency (61% vs. 4%). “This is the first report to find that a [food allergy] program for elementary schoolchildren was well tolerated and that perceptions and attitudes toward [food allergies] improved,” the investigators wrote.

The authors stated that they had no financial conflicts of interest.

Read the full story here: http://dx.doi.org/10.1016/j.anai.2016.06.018

[email protected]

Elementary school students had improved attitudes toward food allergies and felt more confident in taking action during a food allergy emergency after completing an education program on the subject, results of a pilot study in Japan suggest.

At present there is no standard school curriculum for children regarding food allergy, wrote Dr. Kiwako Yamamoto-Hanada of the National Center for Child Health and Development, Tokyo, and associates, so they developed such a program consisting of two 60-minute sessions. A total of 36 elementary school children, 8 of whom had a history of food allergies, filled out questionnaires before and after participating in the program.

After completing the program, 79% of the students stated that it should be included in the school curriculum. Students also demonstrated improved knowledge about food allergies, with a greater percentage knowing what an EpiPen is (100% vs. 0%), understanding that food allergy is related to death (100% vs. 43%), and feeling confident that they could take immediate action if they saw a food allergy emergency (61% vs. 4%). “This is the first report to find that a [food allergy] program for elementary schoolchildren was well tolerated and that perceptions and attitudes toward [food allergies] improved,” the investigators wrote.

The authors stated that they had no financial conflicts of interest.

Read the full story here: http://dx.doi.org/10.1016/j.anai.2016.06.018

[email protected]

Elementary school students had improved attitudes toward food allergies and felt more confident in taking action during a food allergy emergency after completing an education program on the subject, results of a pilot study in Japan suggest.

At present there is no standard school curriculum for children regarding food allergy, wrote Dr. Kiwako Yamamoto-Hanada of the National Center for Child Health and Development, Tokyo, and associates, so they developed such a program consisting of two 60-minute sessions. A total of 36 elementary school children, 8 of whom had a history of food allergies, filled out questionnaires before and after participating in the program.

After completing the program, 79% of the students stated that it should be included in the school curriculum. Students also demonstrated improved knowledge about food allergies, with a greater percentage knowing what an EpiPen is (100% vs. 0%), understanding that food allergy is related to death (100% vs. 43%), and feeling confident that they could take immediate action if they saw a food allergy emergency (61% vs. 4%). “This is the first report to find that a [food allergy] program for elementary schoolchildren was well tolerated and that perceptions and attitudes toward [food allergies] improved,” the investigators wrote.

The authors stated that they had no financial conflicts of interest.

Read the full story here: http://dx.doi.org/10.1016/j.anai.2016.06.018

[email protected]

Influenza-attributable mortality was significantly greater in children with influenza B, compared with influenza A, investigators found.

Among those with influenza B, patients aged 10-16 years were most likely to require ICU admission, suggesting this subpopulation may be a target for immunization programs.

©PhotoEuphoria/Thinkstock

The percentage of clinical cases attributed to influenza B range from less than 1% to 44%, according to data published by the Centers for Disease Control and Prevention. However, influenza B is considered less virulent and less capable of causing pandemics and has therefore been less studied and outcomes of its disease less characterized, Dat Tran, MD, MSc, of the Hospital for Sick Children in Canada and his associates reported (Pediatrics. 2016 August. doi: 10.1542/peds.2015-4643).

The purpose of this study was to further understand the prevalence and severity of influenza B cases in comparison with influenza A and to identify pediatric subpopulations most at risk for contracting influenza B.

Children aged 16 years or younger hospitalized from laboratory-confirmed influenza A or B from September 2004 to June 2013 (excluding the pandemic year 2009-2010) were identified through active surveillance of admissions at the 12 pediatric referral centers of the Canadian Immunization Monitoring Program Active (IMPACT), a national surveillance initiative. Information regarding demographics, health status, vaccination status, presenting signs and symptoms, illness severity and mortality, treatment regimens, and ICU admission were collected and analyzed.

Of 4,155 influenza-related admissions during this time period, influenza B accounted for 1,510 (36.3%) cases and influenza A accounted for 2,645 (63.7%) cases.

Children admitted with influenza B tended to be older with a median age 3.9 years (interquartile range, 1.4-7.2), compared with a median of 2 years (IQR, 0.6-4.8 years) for children admitted with influenza A.

Children admitted with influenza B, compared with influenza A, had higher odds of having a vaccine-indicated condition (odds ratio, 1.30; 95% confidence interval, 1.14-1.47) and lower odds of having no underlying medical condition (OR, 0.80; 95% CI, 0.71-0.91), Dr. Tran and his associates reported.

“Compared with influenza A cases, children admitted with influenza B had greater adjusted odds of presenting with headache, abdominal pain, and myalgia, ranging from 1.38 for abdominal pain to 3.19 for myalgia,” they added. “There were no significant differences in antiviral or antibiotic prescription or use between influenza A and B cases.”

There was no significant difference in the proportion of influenza A or B patients admitted to the ICU (12.7% vs. 12.6%). Rather, multivariate modeling identified age and presence of an underlying condition as independent predictors of ICU admission.

Finally, influenza-attributable mortality was significantly greater in children with influenza B (adjusted OR, 2.65; 95% CI, 1.18-5.94). Influenza-attributable mortality occurred in 16 (1.1%) children with influenza B and only 10 (0.4%) children with influenza A. All-cause mortality followed a similar trend.

“Among hospitalized children, influenza A and B infections resulted in similar morbidity while mortality was greater for influenza B disease. Among healthy children hospitalized with influenza B, those aged 10-16 years were most likely to require ICU admission,” the investigators summarized.

“These children should be considered at high risk for complicated influenza B infection and be specifically targeted by immunization programs to receive influenza vaccination, and in particular, a [quadrivalent influenza vaccine],” they recommended.

This study was funded by GlaxoSmithKline Biologicals SA. The Canadian Immunization Monitoring Program Active is funded by the Public Health Agency of Canada. The investigators reported having no relevant disclosures.

Influenza-attributable mortality was significantly greater in children with influenza B, compared with influenza A, investigators found.

Among those with influenza B, patients aged 10-16 years were most likely to require ICU admission, suggesting this subpopulation may be a target for immunization programs.

©PhotoEuphoria/Thinkstock

The percentage of clinical cases attributed to influenza B range from less than 1% to 44%, according to data published by the Centers for Disease Control and Prevention. However, influenza B is considered less virulent and less capable of causing pandemics and has therefore been less studied and outcomes of its disease less characterized, Dat Tran, MD, MSc, of the Hospital for Sick Children in Canada and his associates reported (Pediatrics. 2016 August. doi: 10.1542/peds.2015-4643).

The purpose of this study was to further understand the prevalence and severity of influenza B cases in comparison with influenza A and to identify pediatric subpopulations most at risk for contracting influenza B.

Children aged 16 years or younger hospitalized from laboratory-confirmed influenza A or B from September 2004 to June 2013 (excluding the pandemic year 2009-2010) were identified through active surveillance of admissions at the 12 pediatric referral centers of the Canadian Immunization Monitoring Program Active (IMPACT), a national surveillance initiative. Information regarding demographics, health status, vaccination status, presenting signs and symptoms, illness severity and mortality, treatment regimens, and ICU admission were collected and analyzed.

Of 4,155 influenza-related admissions during this time period, influenza B accounted for 1,510 (36.3%) cases and influenza A accounted for 2,645 (63.7%) cases.

Children admitted with influenza B tended to be older with a median age 3.9 years (interquartile range, 1.4-7.2), compared with a median of 2 years (IQR, 0.6-4.8 years) for children admitted with influenza A.

Children admitted with influenza B, compared with influenza A, had higher odds of having a vaccine-indicated condition (odds ratio, 1.30; 95% confidence interval, 1.14-1.47) and lower odds of having no underlying medical condition (OR, 0.80; 95% CI, 0.71-0.91), Dr. Tran and his associates reported.

“Compared with influenza A cases, children admitted with influenza B had greater adjusted odds of presenting with headache, abdominal pain, and myalgia, ranging from 1.38 for abdominal pain to 3.19 for myalgia,” they added. “There were no significant differences in antiviral or antibiotic prescription or use between influenza A and B cases.”

There was no significant difference in the proportion of influenza A or B patients admitted to the ICU (12.7% vs. 12.6%). Rather, multivariate modeling identified age and presence of an underlying condition as independent predictors of ICU admission.

Finally, influenza-attributable mortality was significantly greater in children with influenza B (adjusted OR, 2.65; 95% CI, 1.18-5.94). Influenza-attributable mortality occurred in 16 (1.1%) children with influenza B and only 10 (0.4%) children with influenza A. All-cause mortality followed a similar trend.

“Among hospitalized children, influenza A and B infections resulted in similar morbidity while mortality was greater for influenza B disease. Among healthy children hospitalized with influenza B, those aged 10-16 years were most likely to require ICU admission,” the investigators summarized.

“These children should be considered at high risk for complicated influenza B infection and be specifically targeted by immunization programs to receive influenza vaccination, and in particular, a [quadrivalent influenza vaccine],” they recommended.

This study was funded by GlaxoSmithKline Biologicals SA. The Canadian Immunization Monitoring Program Active is funded by the Public Health Agency of Canada. The investigators reported having no relevant disclosures.

Influenza-attributable mortality was significantly greater in children with influenza B, compared with influenza A, investigators found.

Among those with influenza B, patients aged 10-16 years were most likely to require ICU admission, suggesting this subpopulation may be a target for immunization programs.

©PhotoEuphoria/Thinkstock

The percentage of clinical cases attributed to influenza B range from less than 1% to 44%, according to data published by the Centers for Disease Control and Prevention. However, influenza B is considered less virulent and less capable of causing pandemics and has therefore been less studied and outcomes of its disease less characterized, Dat Tran, MD, MSc, of the Hospital for Sick Children in Canada and his associates reported (Pediatrics. 2016 August. doi: 10.1542/peds.2015-4643).

The purpose of this study was to further understand the prevalence and severity of influenza B cases in comparison with influenza A and to identify pediatric subpopulations most at risk for contracting influenza B.

Children aged 16 years or younger hospitalized from laboratory-confirmed influenza A or B from September 2004 to June 2013 (excluding the pandemic year 2009-2010) were identified through active surveillance of admissions at the 12 pediatric referral centers of the Canadian Immunization Monitoring Program Active (IMPACT), a national surveillance initiative. Information regarding demographics, health status, vaccination status, presenting signs and symptoms, illness severity and mortality, treatment regimens, and ICU admission were collected and analyzed.

Of 4,155 influenza-related admissions during this time period, influenza B accounted for 1,510 (36.3%) cases and influenza A accounted for 2,645 (63.7%) cases.

Children admitted with influenza B tended to be older with a median age 3.9 years (interquartile range, 1.4-7.2), compared with a median of 2 years (IQR, 0.6-4.8 years) for children admitted with influenza A.

Children admitted with influenza B, compared with influenza A, had higher odds of having a vaccine-indicated condition (odds ratio, 1.30; 95% confidence interval, 1.14-1.47) and lower odds of having no underlying medical condition (OR, 0.80; 95% CI, 0.71-0.91), Dr. Tran and his associates reported.

“Compared with influenza A cases, children admitted with influenza B had greater adjusted odds of presenting with headache, abdominal pain, and myalgia, ranging from 1.38 for abdominal pain to 3.19 for myalgia,” they added. “There were no significant differences in antiviral or antibiotic prescription or use between influenza A and B cases.”

There was no significant difference in the proportion of influenza A or B patients admitted to the ICU (12.7% vs. 12.6%). Rather, multivariate modeling identified age and presence of an underlying condition as independent predictors of ICU admission.

Finally, influenza-attributable mortality was significantly greater in children with influenza B (adjusted OR, 2.65; 95% CI, 1.18-5.94). Influenza-attributable mortality occurred in 16 (1.1%) children with influenza B and only 10 (0.4%) children with influenza A. All-cause mortality followed a similar trend.

“Among hospitalized children, influenza A and B infections resulted in similar morbidity while mortality was greater for influenza B disease. Among healthy children hospitalized with influenza B, those aged 10-16 years were most likely to require ICU admission,” the investigators summarized.

“These children should be considered at high risk for complicated influenza B infection and be specifically targeted by immunization programs to receive influenza vaccination, and in particular, a [quadrivalent influenza vaccine],” they recommended.

This study was funded by GlaxoSmithKline Biologicals SA. The Canadian Immunization Monitoring Program Active is funded by the Public Health Agency of Canada. The investigators reported having no relevant disclosures.

FROM THE JOURNAL OF ALLERGY AND CLINICAL IMMUNOLOGY: IN PRACTICE

Siblings of children with food allergy should not be screened routinely for such allergies before food introduction, results of a large cohort study suggest.

In a study of 478 food-allergic children and 642 of their siblings, 53% of the siblings were sensitized without clinical reactivity and only 13.6% were found to have a clinically reactive food allergy, wrote Ruchi S. Gupta, MD, of Northwestern University, Chicago, and her associates.

The investigators noted that their findings support current guidelines from the National Institute of Allergy and Infectious Diseases to not screen siblings based on another sibling having a food allergy.

“Given the lack of a dramatically increased risk of food allergy in siblings, compared with that of the general population, as well as the high rate of what are falsely positive diagnostic test results among siblings of a food allergic child, [these siblings] should not have routine screening for food allergy before food introduction,” the investigators concluded. “Such siblings are likely to be mislabeled as allergic when they are actually tolerant to the food, which may lead to an increased risk of developing allergy via avoidance,” and both quality of life and nutrition may be adversely impacted.

Dr. Gupta has received research support from Mylan, Food Allergy Research and Education, and United Health Care.

Read the full study here (http://dx.doi.org/10.1016/j.jaip.2016.04.009)

[email protected]

FROM THE JOURNAL OF ALLERGY AND CLINICAL IMMUNOLOGY: IN PRACTICE

Siblings of children with food allergy should not be screened routinely for such allergies before food introduction, results of a large cohort study suggest.

In a study of 478 food-allergic children and 642 of their siblings, 53% of the siblings were sensitized without clinical reactivity and only 13.6% were found to have a clinically reactive food allergy, wrote Ruchi S. Gupta, MD, of Northwestern University, Chicago, and her associates.

The investigators noted that their findings support current guidelines from the National Institute of Allergy and Infectious Diseases to not screen siblings based on another sibling having a food allergy.

“Given the lack of a dramatically increased risk of food allergy in siblings, compared with that of the general population, as well as the high rate of what are falsely positive diagnostic test results among siblings of a food allergic child, [these siblings] should not have routine screening for food allergy before food introduction,” the investigators concluded. “Such siblings are likely to be mislabeled as allergic when they are actually tolerant to the food, which may lead to an increased risk of developing allergy via avoidance,” and both quality of life and nutrition may be adversely impacted.

Dr. Gupta has received research support from Mylan, Food Allergy Research and Education, and United Health Care.

Read the full study here (http://dx.doi.org/10.1016/j.jaip.2016.04.009)

[email protected]

FROM THE JOURNAL OF ALLERGY AND CLINICAL IMMUNOLOGY: IN PRACTICE

Siblings of children with food allergy should not be screened routinely for such allergies before food introduction, results of a large cohort study suggest.

In a study of 478 food-allergic children and 642 of their siblings, 53% of the siblings were sensitized without clinical reactivity and only 13.6% were found to have a clinically reactive food allergy, wrote Ruchi S. Gupta, MD, of Northwestern University, Chicago, and her associates.

The investigators noted that their findings support current guidelines from the National Institute of Allergy and Infectious Diseases to not screen siblings based on another sibling having a food allergy.

“Given the lack of a dramatically increased risk of food allergy in siblings, compared with that of the general population, as well as the high rate of what are falsely positive diagnostic test results among siblings of a food allergic child, [these siblings] should not have routine screening for food allergy before food introduction,” the investigators concluded. “Such siblings are likely to be mislabeled as allergic when they are actually tolerant to the food, which may lead to an increased risk of developing allergy via avoidance,” and both quality of life and nutrition may be adversely impacted.

Dr. Gupta has received research support from Mylan, Food Allergy Research and Education, and United Health Care.

Read the full study here (http://dx.doi.org/10.1016/j.jaip.2016.04.009)

[email protected]

The PiKo-1 device (nSpire Health) has limited utility in determining forced expiratory volume in 1 second (FEV₁) in children with asthma, according to Jonathan M. Gaffin, MD, and his associates.

In a study of 242 children, spirometry and PiKo-1 devices were used to test FEV1. In the Bland-Altman analysis, it reported a mean difference between FEV₁ measured by spirometry and PiKo-1 of 0.14 L. The PiKo-1 FEV₁ was found to be moderately biased to underestimate FEV₁ with increasing volumes, for every 1-liter increase in spirometry FEV₁, having the difference between spirometry and PiKo-1 increased by 0.19 L (P < .001).

Researchers also used the pulmonary function test (PFT) and t showed variability was 0.4 L for spirometry at 2 SDs, a significant smaller range than seen in the PFT-PiKo confidence intervals (1.1 L). It is noted that this indicates that differences are credited to distinctions in the devices themselves and not within the techniques of the person using them. There was no effect on the order of PFT or PiKo-1 performance (P = .88).

“The findings from this study suggest that the PiKo-1 device has limited utility in assessing FEV₁ in clinical or research settings in children with asthma,” researchers concluded. “Further investigation of its use in this respect and with different populations may prove the device more valuable.”

Find the full study in the Annals of Allergy, Asthma and Immunology (doi: 10.1016/j.anai.2016.06.022).

[email protected]

The PiKo-1 device (nSpire Health) has limited utility in determining forced expiratory volume in 1 second (FEV₁) in children with asthma, according to Jonathan M. Gaffin, MD, and his associates.

In a study of 242 children, spirometry and PiKo-1 devices were used to test FEV1. In the Bland-Altman analysis, it reported a mean difference between FEV₁ measured by spirometry and PiKo-1 of 0.14 L. The PiKo-1 FEV₁ was found to be moderately biased to underestimate FEV₁ with increasing volumes, for every 1-liter increase in spirometry FEV₁, having the difference between spirometry and PiKo-1 increased by 0.19 L (P < .001).

Researchers also used the pulmonary function test (PFT) and t showed variability was 0.4 L for spirometry at 2 SDs, a significant smaller range than seen in the PFT-PiKo confidence intervals (1.1 L). It is noted that this indicates that differences are credited to distinctions in the devices themselves and not within the techniques of the person using them. There was no effect on the order of PFT or PiKo-1 performance (P = .88).

“The findings from this study suggest that the PiKo-1 device has limited utility in assessing FEV₁ in clinical or research settings in children with asthma,” researchers concluded. “Further investigation of its use in this respect and with different populations may prove the device more valuable.”

Find the full study in the Annals of Allergy, Asthma and Immunology (doi: 10.1016/j.anai.2016.06.022).

[email protected]

The PiKo-1 device (nSpire Health) has limited utility in determining forced expiratory volume in 1 second (FEV₁) in children with asthma, according to Jonathan M. Gaffin, MD, and his associates.

In a study of 242 children, spirometry and PiKo-1 devices were used to test FEV1. In the Bland-Altman analysis, it reported a mean difference between FEV₁ measured by spirometry and PiKo-1 of 0.14 L. The PiKo-1 FEV₁ was found to be moderately biased to underestimate FEV₁ with increasing volumes, for every 1-liter increase in spirometry FEV₁, having the difference between spirometry and PiKo-1 increased by 0.19 L (P < .001).

Researchers also used the pulmonary function test (PFT) and t showed variability was 0.4 L for spirometry at 2 SDs, a significant smaller range than seen in the PFT-PiKo confidence intervals (1.1 L). It is noted that this indicates that differences are credited to distinctions in the devices themselves and not within the techniques of the person using them. There was no effect on the order of PFT or PiKo-1 performance (P = .88).

“The findings from this study suggest that the PiKo-1 device has limited utility in assessing FEV₁ in clinical or research settings in children with asthma,” researchers concluded. “Further investigation of its use in this respect and with different populations may prove the device more valuable.”

Find the full study in the Annals of Allergy, Asthma and Immunology (doi: 10.1016/j.anai.2016.06.022).

[email protected]

DURBAN, SOUTH AFRICA – Prescribing high-dose rifampicin in addition to antiretroviral therapy reduces 12-month all-cause mortality in patients who are coinfected with tuberculosis and HIV and who have a low CD4 cell count, Corinne S. Merle, MD, reported at the 21st International AIDS Conference.

“Current strategies to reduce TB/HIV mortality rely largely on optimal management of HIV disease with early ART [antiretroviral therapy]. We wanted to look at whether there is value in focusing on the TB side of the problem. This is the first study to look at more intensive TB therapy for reducing mortality; and we think that, at least in patients who are immunosuppressed, there might be some benefit in a more aggressive TB treatment from the start,” said Dr. Merle of the London School of Hygiene and Tropical Medicine.

She presented the results of the open-label, multicenter trial of 747 ART-naive adults from West Africa. All were coinfected with TB/HIV and had a CD4 count of at least 50 cells/mm³ at enrollment. They were randomized to one of three treatment arms: ART starting at 2 weeks combined with standard TB treatment; ART starting at 8 weeks plus standard TB therapy; or ART initiation at 8 weeks coupled with 2 months of high-dose rifampicin (Rifadin) at 15 mg/kg daily, followed by standard TB therapy. None of the participants had multidrug-resistant TB. More than one-quarter of them were undernourished as evidenced by a baseline body mass index below 16 kg/m².

The primary outcome was all-cause mortality at 12 months. There was no significant difference between the study arms, with a 10% rate in the intensified TB treatment arm and mortality rates of 11% and 14% with standard TB therapy and ART starting after 2 and 8 weeks, respectively.

However, a prespecified secondary analysis restricted to the 159 subjects with a baseline CD4 count below 100 cells/mm³ struck gold. Overall 12-month mortality was 4% in the intensified TB treatment subgroup, compared with 19% in patients on standard TB therapy with ART starting at 2 weeks and 28% with ART starting at 8 weeks. In a Cox regression analysis, severely immunosuppressed patients in the high-dose rifampicin group were an adjusted 88% less likely to die within 12 months than those on standard TB treatment with ART starting at 8 weeks and 80% less likely to die than those starting ART at 2 weeks.

At 18 months after randomization, roughly three-quarters of patients in each study arm had undetectable HIV viral loads.

There was no evidence of an increased risk of hepatotoxicity with 2 months of high-dose rifampicin. Only 4 of nearly 3,800 aspartate aminotransferase measurements obtained during the trial showed grade 3 or 4 hepatotoxicity, Dr. Merle noted.

In a plenary lecture on TB/HIV coinfection at the AIDS 2016 conference, Anton Pozniak, MD, singled out the trial as a sterling example of how to optimize available clinical management tools while awaiting a desperately needed new TB vaccine and better drugs.

More than 1 million new TB cases occur annually in HIV-infected persons, roughly 80% of them in sub-Saharan Africa. There are now 400,000 deaths per year worldwide in coinfected TB/HIV patients. Indeed, TB has become the No. 1 cause of death among people living with HIV infection, said Dr. Pozniak, director of HIV services at Chelsea and Westminster Hospital in London.

He offered a road map to eliminating TB by the year 2035. At present, the global trend is a 2% per year decline in new cases. Optimizing TB case finding, treatment, and preventive therapy could achieve a 10% per year decrease in new cases. That rate still wouldn’t reach the goal by 2035. But more than a dozen candidate TB vaccines are in the developmental pipeline, including a mycobacterial whole cell extract in phase III testing in China. If a new vaccine can be introduced by 2025, that would be a game changer.

“A new vaccine that could prevent adolescents and adults from developing and transmitting TB would be the single most cost-effective tool in mitigating the epidemic,” he said. “Even if we had only a 60% efficacious vaccine and delivered it to 20% of the target population, it could potentially avert 30-50 million incident cases of TB by 2050.”

A new vaccine plus effective alternatives to the standard 6 months of isoniazid for latency prophylaxis by 2025 are estimated to reduce new cases of TB by an average of 17% per year. That circumstance would mean the end of TB by 2035, Dr. Pozniak declared.

The trial was funded by the European and Developing Countries Clinical Trials Partnership. Dr. Merle reported having no financial conflicts of interest.

[email protected]

DURBAN, SOUTH AFRICA – Prescribing high-dose rifampicin in addition to antiretroviral therapy reduces 12-month all-cause mortality in patients who are coinfected with tuberculosis and HIV and who have a low CD4 cell count, Corinne S. Merle, MD, reported at the 21st International AIDS Conference.

“Current strategies to reduce TB/HIV mortality rely largely on optimal management of HIV disease with early ART [antiretroviral therapy]. We wanted to look at whether there is value in focusing on the TB side of the problem. This is the first study to look at more intensive TB therapy for reducing mortality; and we think that, at least in patients who are immunosuppressed, there might be some benefit in a more aggressive TB treatment from the start,” said Dr. Merle of the London School of Hygiene and Tropical Medicine.

She presented the results of the open-label, multicenter trial of 747 ART-naive adults from West Africa. All were coinfected with TB/HIV and had a CD4 count of at least 50 cells/mm³ at enrollment. They were randomized to one of three treatment arms: ART starting at 2 weeks combined with standard TB treatment; ART starting at 8 weeks plus standard TB therapy; or ART initiation at 8 weeks coupled with 2 months of high-dose rifampicin (Rifadin) at 15 mg/kg daily, followed by standard TB therapy. None of the participants had multidrug-resistant TB. More than one-quarter of them were undernourished as evidenced by a baseline body mass index below 16 kg/m².

The primary outcome was all-cause mortality at 12 months. There was no significant difference between the study arms, with a 10% rate in the intensified TB treatment arm and mortality rates of 11% and 14% with standard TB therapy and ART starting after 2 and 8 weeks, respectively.

However, a prespecified secondary analysis restricted to the 159 subjects with a baseline CD4 count below 100 cells/mm³ struck gold. Overall 12-month mortality was 4% in the intensified TB treatment subgroup, compared with 19% in patients on standard TB therapy with ART starting at 2 weeks and 28% with ART starting at 8 weeks. In a Cox regression analysis, severely immunosuppressed patients in the high-dose rifampicin group were an adjusted 88% less likely to die within 12 months than those on standard TB treatment with ART starting at 8 weeks and 80% less likely to die than those starting ART at 2 weeks.

At 18 months after randomization, roughly three-quarters of patients in each study arm had undetectable HIV viral loads.

There was no evidence of an increased risk of hepatotoxicity with 2 months of high-dose rifampicin. Only 4 of nearly 3,800 aspartate aminotransferase measurements obtained during the trial showed grade 3 or 4 hepatotoxicity, Dr. Merle noted.

In a plenary lecture on TB/HIV coinfection at the AIDS 2016 conference, Anton Pozniak, MD, singled out the trial as a sterling example of how to optimize available clinical management tools while awaiting a desperately needed new TB vaccine and better drugs.

More than 1 million new TB cases occur annually in HIV-infected persons, roughly 80% of them in sub-Saharan Africa. There are now 400,000 deaths per year worldwide in coinfected TB/HIV patients. Indeed, TB has become the No. 1 cause of death among people living with HIV infection, said Dr. Pozniak, director of HIV services at Chelsea and Westminster Hospital in London.

He offered a road map to eliminating TB by the year 2035. At present, the global trend is a 2% per year decline in new cases. Optimizing TB case finding, treatment, and preventive therapy could achieve a 10% per year decrease in new cases. That rate still wouldn’t reach the goal by 2035. But more than a dozen candidate TB vaccines are in the developmental pipeline, including a mycobacterial whole cell extract in phase III testing in China. If a new vaccine can be introduced by 2025, that would be a game changer.

“A new vaccine that could prevent adolescents and adults from developing and transmitting TB would be the single most cost-effective tool in mitigating the epidemic,” he said. “Even if we had only a 60% efficacious vaccine and delivered it to 20% of the target population, it could potentially avert 30-50 million incident cases of TB by 2050.”

A new vaccine plus effective alternatives to the standard 6 months of isoniazid for latency prophylaxis by 2025 are estimated to reduce new cases of TB by an average of 17% per year. That circumstance would mean the end of TB by 2035, Dr. Pozniak declared.

The trial was funded by the European and Developing Countries Clinical Trials Partnership. Dr. Merle reported having no financial conflicts of interest.

[email protected]

DURBAN, SOUTH AFRICA – Prescribing high-dose rifampicin in addition to antiretroviral therapy reduces 12-month all-cause mortality in patients who are coinfected with tuberculosis and HIV and who have a low CD4 cell count, Corinne S. Merle, MD, reported at the 21st International AIDS Conference.

“Current strategies to reduce TB/HIV mortality rely largely on optimal management of HIV disease with early ART [antiretroviral therapy]. We wanted to look at whether there is value in focusing on the TB side of the problem. This is the first study to look at more intensive TB therapy for reducing mortality; and we think that, at least in patients who are immunosuppressed, there might be some benefit in a more aggressive TB treatment from the start,” said Dr. Merle of the London School of Hygiene and Tropical Medicine.

She presented the results of the open-label, multicenter trial of 747 ART-naive adults from West Africa. All were coinfected with TB/HIV and had a CD4 count of at least 50 cells/mm³ at enrollment. They were randomized to one of three treatment arms: ART starting at 2 weeks combined with standard TB treatment; ART starting at 8 weeks plus standard TB therapy; or ART initiation at 8 weeks coupled with 2 months of high-dose rifampicin (Rifadin) at 15 mg/kg daily, followed by standard TB therapy. None of the participants had multidrug-resistant TB. More than one-quarter of them were undernourished as evidenced by a baseline body mass index below 16 kg/m².

The primary outcome was all-cause mortality at 12 months. There was no significant difference between the study arms, with a 10% rate in the intensified TB treatment arm and mortality rates of 11% and 14% with standard TB therapy and ART starting after 2 and 8 weeks, respectively.

However, a prespecified secondary analysis restricted to the 159 subjects with a baseline CD4 count below 100 cells/mm³ struck gold. Overall 12-month mortality was 4% in the intensified TB treatment subgroup, compared with 19% in patients on standard TB therapy with ART starting at 2 weeks and 28% with ART starting at 8 weeks. In a Cox regression analysis, severely immunosuppressed patients in the high-dose rifampicin group were an adjusted 88% less likely to die within 12 months than those on standard TB treatment with ART starting at 8 weeks and 80% less likely to die than those starting ART at 2 weeks.

At 18 months after randomization, roughly three-quarters of patients in each study arm had undetectable HIV viral loads.

There was no evidence of an increased risk of hepatotoxicity with 2 months of high-dose rifampicin. Only 4 of nearly 3,800 aspartate aminotransferase measurements obtained during the trial showed grade 3 or 4 hepatotoxicity, Dr. Merle noted.

In a plenary lecture on TB/HIV coinfection at the AIDS 2016 conference, Anton Pozniak, MD, singled out the trial as a sterling example of how to optimize available clinical management tools while awaiting a desperately needed new TB vaccine and better drugs.

More than 1 million new TB cases occur annually in HIV-infected persons, roughly 80% of them in sub-Saharan Africa. There are now 400,000 deaths per year worldwide in coinfected TB/HIV patients. Indeed, TB has become the No. 1 cause of death among people living with HIV infection, said Dr. Pozniak, director of HIV services at Chelsea and Westminster Hospital in London.

He offered a road map to eliminating TB by the year 2035. At present, the global trend is a 2% per year decline in new cases. Optimizing TB case finding, treatment, and preventive therapy could achieve a 10% per year decrease in new cases. That rate still wouldn’t reach the goal by 2035. But more than a dozen candidate TB vaccines are in the developmental pipeline, including a mycobacterial whole cell extract in phase III testing in China. If a new vaccine can be introduced by 2025, that would be a game changer.

“A new vaccine that could prevent adolescents and adults from developing and transmitting TB would be the single most cost-effective tool in mitigating the epidemic,” he said. “Even if we had only a 60% efficacious vaccine and delivered it to 20% of the target population, it could potentially avert 30-50 million incident cases of TB by 2050.”

A new vaccine plus effective alternatives to the standard 6 months of isoniazid for latency prophylaxis by 2025 are estimated to reduce new cases of TB by an average of 17% per year. That circumstance would mean the end of TB by 2035, Dr. Pozniak declared.

The trial was funded by the European and Developing Countries Clinical Trials Partnership. Dr. Merle reported having no financial conflicts of interest.

[email protected]