M. Alexander Otto

 

ATLANTA – One year or more after peanut immunotherapy, 27 of 33 (82%) children were eating peanuts regularly, most without problems, in a survey from the Children’s Hospital of Philadelphia.

The finding speaks to the durability of peanut immunotherapy, something that’s been a concern for physicians and families. It suggests that peanut immunotherapy might give children long-term protection from accidental exposure, so long as they continue to eat a small amount of peanut almost every day after desensitization.

M. Alexander Otto/Frontline Medical News

However, four children (12%) who ate more than one peanut a day had anaphylactic reactions that required epinephrine. The right maintenance dose after peanut allergy treatment isn’t known, but perhaps one peanut a day (300 mg) is enough. Eating more than that might increase the risk of reaction, lead investigator and pediatric nurse practitioner Megan T. Ott Lewis, the food allergy research program manager at the Children’s Hospital of Philadelphia, reported at the annual meeting of the American Academy of Asthma, Allergy, and Immunology.

She and her team surveyed the families of 15 children who completed a trial of epicutaneous peanut immunotherapy (EPIT) and 9 who completed a trial of oral immunotherapy (OIT) about a year after the studies ended. They also surveyed families of nine children about 2 years after they completed a trial of OIT plus omalizumab (Xolair) for peanut allergy. The investigators and families chose maintenance doses based on results from the final peanut challenges, and children were warned against running around within 2 hours of their dose, to prevent exercised-induced reactions.

The point of using omalizumab in the one trial was to see if it helped children ramp up immunotherapy more quickly and tolerate higher final peanut doses. It did, and the nine omalizumab children were on the highest maintenance doses of peanut at 2-year follow-up, with almost all of them consuming an average of at least one peanut a day. Perhaps because of that, three of the four anaphylactic reactions were in the omalizumab group.

The fourth reaction was in a child who completed the OIT trial. There was no anaphylaxis in EPIT children. About 60% in both groups reported eating an average of at least a peanut a day at 1-year follow-up.

About three-quarters of the children ate peanut-containing candy to get their maintenance dose. Others ate peanuts or peanut butter or sprinkled peanut flour on their food. Just six children, all from the EPIT cohort, said they liked the taste of peanuts.

Meanwhile, 6 of the 33 children (18%) – 1 in the omalizumab group, 3 in the EPIT arm, and 2 in the OIT group – refused to eat peanuts after their immunotherapy trials.

Posttrial peanut dosing ranged from once a month to daily, and the majority of subjects ate peanut about five times per week. All of the anaphylaxis children recovered without incident and resumed peanut maintenance. A couple of the children in the EPIT group had an itch in their throat when they switched to eating peanuts, but it resolved on its own. One child in the omalizumab group and one in the OIT group reported gastrointestinal symptoms with maintenance dosing.

The original trials funded the follow-up. Ms. Ott Lewis had no relevant financial disclosures.

[email protected]

 

ATLANTA – One year or more after peanut immunotherapy, 27 of 33 (82%) children were eating peanuts regularly, most without problems, in a survey from the Children’s Hospital of Philadelphia.

The finding speaks to the durability of peanut immunotherapy, something that’s been a concern for physicians and families. It suggests that peanut immunotherapy might give children long-term protection from accidental exposure, so long as they continue to eat a small amount of peanut almost every day after desensitization.

M. Alexander Otto/Frontline Medical News

However, four children (12%) who ate more than one peanut a day had anaphylactic reactions that required epinephrine. The right maintenance dose after peanut allergy treatment isn’t known, but perhaps one peanut a day (300 mg) is enough. Eating more than that might increase the risk of reaction, lead investigator and pediatric nurse practitioner Megan T. Ott Lewis, the food allergy research program manager at the Children’s Hospital of Philadelphia, reported at the annual meeting of the American Academy of Asthma, Allergy, and Immunology.

She and her team surveyed the families of 15 children who completed a trial of epicutaneous peanut immunotherapy (EPIT) and 9 who completed a trial of oral immunotherapy (OIT) about a year after the studies ended. They also surveyed families of nine children about 2 years after they completed a trial of OIT plus omalizumab (Xolair) for peanut allergy. The investigators and families chose maintenance doses based on results from the final peanut challenges, and children were warned against running around within 2 hours of their dose, to prevent exercised-induced reactions.

The point of using omalizumab in the one trial was to see if it helped children ramp up immunotherapy more quickly and tolerate higher final peanut doses. It did, and the nine omalizumab children were on the highest maintenance doses of peanut at 2-year follow-up, with almost all of them consuming an average of at least one peanut a day. Perhaps because of that, three of the four anaphylactic reactions were in the omalizumab group.

The fourth reaction was in a child who completed the OIT trial. There was no anaphylaxis in EPIT children. About 60% in both groups reported eating an average of at least a peanut a day at 1-year follow-up.

About three-quarters of the children ate peanut-containing candy to get their maintenance dose. Others ate peanuts or peanut butter or sprinkled peanut flour on their food. Just six children, all from the EPIT cohort, said they liked the taste of peanuts.

Meanwhile, 6 of the 33 children (18%) – 1 in the omalizumab group, 3 in the EPIT arm, and 2 in the OIT group – refused to eat peanuts after their immunotherapy trials.

Posttrial peanut dosing ranged from once a month to daily, and the majority of subjects ate peanut about five times per week. All of the anaphylaxis children recovered without incident and resumed peanut maintenance. A couple of the children in the EPIT group had an itch in their throat when they switched to eating peanuts, but it resolved on its own. One child in the omalizumab group and one in the OIT group reported gastrointestinal symptoms with maintenance dosing.

The original trials funded the follow-up. Ms. Ott Lewis had no relevant financial disclosures.

[email protected]

 

ATLANTA – One year or more after peanut immunotherapy, 27 of 33 (82%) children were eating peanuts regularly, most without problems, in a survey from the Children’s Hospital of Philadelphia.

The finding speaks to the durability of peanut immunotherapy, something that’s been a concern for physicians and families. It suggests that peanut immunotherapy might give children long-term protection from accidental exposure, so long as they continue to eat a small amount of peanut almost every day after desensitization.

M. Alexander Otto/Frontline Medical News

However, four children (12%) who ate more than one peanut a day had anaphylactic reactions that required epinephrine. The right maintenance dose after peanut allergy treatment isn’t known, but perhaps one peanut a day (300 mg) is enough. Eating more than that might increase the risk of reaction, lead investigator and pediatric nurse practitioner Megan T. Ott Lewis, the food allergy research program manager at the Children’s Hospital of Philadelphia, reported at the annual meeting of the American Academy of Asthma, Allergy, and Immunology.

She and her team surveyed the families of 15 children who completed a trial of epicutaneous peanut immunotherapy (EPIT) and 9 who completed a trial of oral immunotherapy (OIT) about a year after the studies ended. They also surveyed families of nine children about 2 years after they completed a trial of OIT plus omalizumab (Xolair) for peanut allergy. The investigators and families chose maintenance doses based on results from the final peanut challenges, and children were warned against running around within 2 hours of their dose, to prevent exercised-induced reactions.

The point of using omalizumab in the one trial was to see if it helped children ramp up immunotherapy more quickly and tolerate higher final peanut doses. It did, and the nine omalizumab children were on the highest maintenance doses of peanut at 2-year follow-up, with almost all of them consuming an average of at least one peanut a day. Perhaps because of that, three of the four anaphylactic reactions were in the omalizumab group.

The fourth reaction was in a child who completed the OIT trial. There was no anaphylaxis in EPIT children. About 60% in both groups reported eating an average of at least a peanut a day at 1-year follow-up.

About three-quarters of the children ate peanut-containing candy to get their maintenance dose. Others ate peanuts or peanut butter or sprinkled peanut flour on their food. Just six children, all from the EPIT cohort, said they liked the taste of peanuts.

Meanwhile, 6 of the 33 children (18%) – 1 in the omalizumab group, 3 in the EPIT arm, and 2 in the OIT group – refused to eat peanuts after their immunotherapy trials.

Posttrial peanut dosing ranged from once a month to daily, and the majority of subjects ate peanut about five times per week. All of the anaphylaxis children recovered without incident and resumed peanut maintenance. A couple of the children in the EPIT group had an itch in their throat when they switched to eating peanuts, but it resolved on its own. One child in the omalizumab group and one in the OIT group reported gastrointestinal symptoms with maintenance dosing.

The original trials funded the follow-up. Ms. Ott Lewis had no relevant financial disclosures.

[email protected]

 

ATLANTA – Summer camp personnel need a refresher course on the recognition, treatment, and prevention of allergic reactions in children, according to an online survey of camps in almost 40 U.S. states and Canadian provinces.

There’s a lot of data about how schools handle allergies but almost nothing about summer camps. To fill the gap, the investigators sent surveys across North America to 158 camp directors, 141 camp medical personnel – mostly registered nurses – and 198 camp staffers. Most of the camps were traditional rural affairs where children stay for several weeks, but there were also suburban and city day camps.

M. Alexander Otto/Frontline Medical News

“Parents have questions, but we really didn’t have any data” about what happens at camp, senior investigator John Lee, MD, director of the food allergy program at Boston Children’s Hospital, reported at the annual meeting of the American Academy of Allergy, Asthma, and Immunology.

The results weren’t good. About a third of directors and staff, and almost 20% of medical personnel, said they had no education on food allergies. Less than 40% had a good understanding of the different ways that anaphylaxis can present. Less than 80% of camp directors and medical personnel and less than 50% of staff knew the right sequence for anaphylaxis treatment – epinephrine first, followed by a 911 call, and then a call to parents. Many respondents didn’t know the correct injection site for epinephrine.

They also were confused about hand sanitizers versus soap and water. Many mistakenly thought that sanitizers were as good as washing for removing allergens. “Their knowledge about how to clean tables and clean hands of food allergens was limited,” said lead investigator Margaret T. Redmond, MD, an allergist at Nationwide Children’s Hospital in Columbus, Ohio.

Meanwhile, less than half of camp directors said they required a food allergy action plan, and about 20% of camps didn’t have epinephrine on site. About a third let children go on day trips without their autoinjectors. About a fifth of camps said it would take more than 10 minutes for an anaphylactic child to get an epinephrine shot.

It all points to the need for education. “We were surprised at the poor recognition of anaphylactic symptoms. We are trying to identify the weaknesses in camps for targeted interventions. We know from the school data that, with education, people can change,” Dr. Redmond said.

During the 2016 summer session, 51 camps agreed to report epinephrine. Most were rural, with an average of 150 campers per day staying a median of 51 days. There were 12 epinephrine shots over that time, about half for peanut reactions and the rest for bee, wasp, and fire ant stings. None of the children died.

“Families that have kids with food allergies should reach out to camps about their policies and make sure they have epinephrine available at all times and that they have food allergy action plans” that staff know about, Dr. Redmond said.

The work was funded by Mylan and kaleo, both makers of epinephrine autoinjectors. Dr. Lee and Dr. Redmond had no relevant financial disclosures.

[email protected]
 

 

ATLANTA – Summer camp personnel need a refresher course on the recognition, treatment, and prevention of allergic reactions in children, according to an online survey of camps in almost 40 U.S. states and Canadian provinces.

There’s a lot of data about how schools handle allergies but almost nothing about summer camps. To fill the gap, the investigators sent surveys across North America to 158 camp directors, 141 camp medical personnel – mostly registered nurses – and 198 camp staffers. Most of the camps were traditional rural affairs where children stay for several weeks, but there were also suburban and city day camps.

M. Alexander Otto/Frontline Medical News

“Parents have questions, but we really didn’t have any data” about what happens at camp, senior investigator John Lee, MD, director of the food allergy program at Boston Children’s Hospital, reported at the annual meeting of the American Academy of Allergy, Asthma, and Immunology.

The results weren’t good. About a third of directors and staff, and almost 20% of medical personnel, said they had no education on food allergies. Less than 40% had a good understanding of the different ways that anaphylaxis can present. Less than 80% of camp directors and medical personnel and less than 50% of staff knew the right sequence for anaphylaxis treatment – epinephrine first, followed by a 911 call, and then a call to parents. Many respondents didn’t know the correct injection site for epinephrine.

They also were confused about hand sanitizers versus soap and water. Many mistakenly thought that sanitizers were as good as washing for removing allergens. “Their knowledge about how to clean tables and clean hands of food allergens was limited,” said lead investigator Margaret T. Redmond, MD, an allergist at Nationwide Children’s Hospital in Columbus, Ohio.

Meanwhile, less than half of camp directors said they required a food allergy action plan, and about 20% of camps didn’t have epinephrine on site. About a third let children go on day trips without their autoinjectors. About a fifth of camps said it would take more than 10 minutes for an anaphylactic child to get an epinephrine shot.

It all points to the need for education. “We were surprised at the poor recognition of anaphylactic symptoms. We are trying to identify the weaknesses in camps for targeted interventions. We know from the school data that, with education, people can change,” Dr. Redmond said.

During the 2016 summer session, 51 camps agreed to report epinephrine. Most were rural, with an average of 150 campers per day staying a median of 51 days. There were 12 epinephrine shots over that time, about half for peanut reactions and the rest for bee, wasp, and fire ant stings. None of the children died.

“Families that have kids with food allergies should reach out to camps about their policies and make sure they have epinephrine available at all times and that they have food allergy action plans” that staff know about, Dr. Redmond said.

The work was funded by Mylan and kaleo, both makers of epinephrine autoinjectors. Dr. Lee and Dr. Redmond had no relevant financial disclosures.

[email protected]
 

 

ATLANTA – Summer camp personnel need a refresher course on the recognition, treatment, and prevention of allergic reactions in children, according to an online survey of camps in almost 40 U.S. states and Canadian provinces.

There’s a lot of data about how schools handle allergies but almost nothing about summer camps. To fill the gap, the investigators sent surveys across North America to 158 camp directors, 141 camp medical personnel – mostly registered nurses – and 198 camp staffers. Most of the camps were traditional rural affairs where children stay for several weeks, but there were also suburban and city day camps.

M. Alexander Otto/Frontline Medical News

“Parents have questions, but we really didn’t have any data” about what happens at camp, senior investigator John Lee, MD, director of the food allergy program at Boston Children’s Hospital, reported at the annual meeting of the American Academy of Allergy, Asthma, and Immunology.

The results weren’t good. About a third of directors and staff, and almost 20% of medical personnel, said they had no education on food allergies. Less than 40% had a good understanding of the different ways that anaphylaxis can present. Less than 80% of camp directors and medical personnel and less than 50% of staff knew the right sequence for anaphylaxis treatment – epinephrine first, followed by a 911 call, and then a call to parents. Many respondents didn’t know the correct injection site for epinephrine.

They also were confused about hand sanitizers versus soap and water. Many mistakenly thought that sanitizers were as good as washing for removing allergens. “Their knowledge about how to clean tables and clean hands of food allergens was limited,” said lead investigator Margaret T. Redmond, MD, an allergist at Nationwide Children’s Hospital in Columbus, Ohio.

Meanwhile, less than half of camp directors said they required a food allergy action plan, and about 20% of camps didn’t have epinephrine on site. About a third let children go on day trips without their autoinjectors. About a fifth of camps said it would take more than 10 minutes for an anaphylactic child to get an epinephrine shot.

It all points to the need for education. “We were surprised at the poor recognition of anaphylactic symptoms. We are trying to identify the weaknesses in camps for targeted interventions. We know from the school data that, with education, people can change,” Dr. Redmond said.

During the 2016 summer session, 51 camps agreed to report epinephrine. Most were rural, with an average of 150 campers per day staying a median of 51 days. There were 12 epinephrine shots over that time, about half for peanut reactions and the rest for bee, wasp, and fire ant stings. None of the children died.

“Families that have kids with food allergies should reach out to camps about their policies and make sure they have epinephrine available at all times and that they have food allergy action plans” that staff know about, Dr. Redmond said.

The work was funded by Mylan and kaleo, both makers of epinephrine autoinjectors. Dr. Lee and Dr. Redmond had no relevant financial disclosures.

[email protected]
 

 

ATLANTA – By the time adults with severe, chronic ear pain end up at the Mayo Clinic in Rochester, Minn., it’s not uncommon for them to have failed antibiotics and gone through a dozen or more sets of ear tubes that didn’t work, followed by surgery – mastoidectomy – to no avail.

“When they get to us, they are struggling. It’s miserable,” said allergist Erin Willits, MD, of Mayo’s division of allergy and immunology inRochester, Minn.

What all those patients have in common is a recently described disease entity called eosinophilic otitis media (EOM). “People aren’t that aware of it. It’s underrecognized,” she said.

Dr. Willits and her colleagues described the first cohort ever assembled in the United States at the annual meeting of the American Academy of Allergy, Asthma, and Immunology. Most of the research into EOM has been done in Japan, but Mayo has recognized the problem and ENT doctors and allergists there are working together to identify and treat patients. So far, interferon injections seem to be the best option.

The common denominator in all 32 patients was a history of asthma and nasal polyps. Perhaps in EOM, eosinophilic lung and sinus inflammation extends to the eustachian tubes, but that’s not clear yet. Some of the patients also had polyps in their ear canals, and 13 (41%) had a convincing history of aspirin sensitivity. They also had viscous middle-ear effusions, which is why ear tubes don’t help.

In short, the researchers found that a history of asthma and nasal polyps should trigger investigation for EOM in adults with chronic, refractory ear pain.

Of 25 patients, 19 (76%) also had ear disease on CT scan, most commonly inner ear or mastoid opacification. Eighteen patients tested had eosinophilic cationic protein levels above 1,000 ng/mL in their middle-ear effusions, which is high, and 12 out of 30 (40%) were markedly eosinophilic on CBC. The average age of EOM onset was 55.5 years. There were 17 women and 15 men in the cohort.

There was some degree of bilateral hearing loss in nearly every patient, generally a mix of conductive and sensorineural deficits.

“A lot of them start off with conductive hearing loss and progress to sensorineural hearing loss, which can be permanent,” Dr. Willits said. “That’s the biggest thing I want people to recognize: If you start to work with an ENT to try to [identify and] treat these patients, you hopefully can prevent hearing loss.”

Many patients have a robust response to pegylated interferon-alpha. “It kind of dries up their ears, and they feel better,” Dr. Willits noted. Usually it’s given every 2-4 weeks, but some patients can get away with every 6 weeks and lower doses. The side effects are rough, however, and symptoms come back if it’s stopped. It’s also hard to get insurance companies to cover it for EOM (Laryngoscope. 2016 Sep 26. doi: 10.1002/lary.26303).

“It’s not a great treatment, but it’s about all we have,” she said. Omalizumab (Xolair) “has been tried, but it doesn’t help a lot of patients. We are hopeful some of these newer biologics” – such as dupilumab or mepolizumab (Nucala) – “will give these patients relief.”

Dr. Willits had no relevant disclosures.

[email protected]

 

ATLANTA – By the time adults with severe, chronic ear pain end up at the Mayo Clinic in Rochester, Minn., it’s not uncommon for them to have failed antibiotics and gone through a dozen or more sets of ear tubes that didn’t work, followed by surgery – mastoidectomy – to no avail.

“When they get to us, they are struggling. It’s miserable,” said allergist Erin Willits, MD, of Mayo’s division of allergy and immunology inRochester, Minn.

What all those patients have in common is a recently described disease entity called eosinophilic otitis media (EOM). “People aren’t that aware of it. It’s underrecognized,” she said.

Dr. Willits and her colleagues described the first cohort ever assembled in the United States at the annual meeting of the American Academy of Allergy, Asthma, and Immunology. Most of the research into EOM has been done in Japan, but Mayo has recognized the problem and ENT doctors and allergists there are working together to identify and treat patients. So far, interferon injections seem to be the best option.

The common denominator in all 32 patients was a history of asthma and nasal polyps. Perhaps in EOM, eosinophilic lung and sinus inflammation extends to the eustachian tubes, but that’s not clear yet. Some of the patients also had polyps in their ear canals, and 13 (41%) had a convincing history of aspirin sensitivity. They also had viscous middle-ear effusions, which is why ear tubes don’t help.

In short, the researchers found that a history of asthma and nasal polyps should trigger investigation for EOM in adults with chronic, refractory ear pain.

Of 25 patients, 19 (76%) also had ear disease on CT scan, most commonly inner ear or mastoid opacification. Eighteen patients tested had eosinophilic cationic protein levels above 1,000 ng/mL in their middle-ear effusions, which is high, and 12 out of 30 (40%) were markedly eosinophilic on CBC. The average age of EOM onset was 55.5 years. There were 17 women and 15 men in the cohort.

There was some degree of bilateral hearing loss in nearly every patient, generally a mix of conductive and sensorineural deficits.

“A lot of them start off with conductive hearing loss and progress to sensorineural hearing loss, which can be permanent,” Dr. Willits said. “That’s the biggest thing I want people to recognize: If you start to work with an ENT to try to [identify and] treat these patients, you hopefully can prevent hearing loss.”

Many patients have a robust response to pegylated interferon-alpha. “It kind of dries up their ears, and they feel better,” Dr. Willits noted. Usually it’s given every 2-4 weeks, but some patients can get away with every 6 weeks and lower doses. The side effects are rough, however, and symptoms come back if it’s stopped. It’s also hard to get insurance companies to cover it for EOM (Laryngoscope. 2016 Sep 26. doi: 10.1002/lary.26303).

“It’s not a great treatment, but it’s about all we have,” she said. Omalizumab (Xolair) “has been tried, but it doesn’t help a lot of patients. We are hopeful some of these newer biologics” – such as dupilumab or mepolizumab (Nucala) – “will give these patients relief.”

Dr. Willits had no relevant disclosures.

[email protected]

 

ATLANTA – By the time adults with severe, chronic ear pain end up at the Mayo Clinic in Rochester, Minn., it’s not uncommon for them to have failed antibiotics and gone through a dozen or more sets of ear tubes that didn’t work, followed by surgery – mastoidectomy – to no avail.

“When they get to us, they are struggling. It’s miserable,” said allergist Erin Willits, MD, of Mayo’s division of allergy and immunology inRochester, Minn.

What all those patients have in common is a recently described disease entity called eosinophilic otitis media (EOM). “People aren’t that aware of it. It’s underrecognized,” she said.

Dr. Willits and her colleagues described the first cohort ever assembled in the United States at the annual meeting of the American Academy of Allergy, Asthma, and Immunology. Most of the research into EOM has been done in Japan, but Mayo has recognized the problem and ENT doctors and allergists there are working together to identify and treat patients. So far, interferon injections seem to be the best option.

The common denominator in all 32 patients was a history of asthma and nasal polyps. Perhaps in EOM, eosinophilic lung and sinus inflammation extends to the eustachian tubes, but that’s not clear yet. Some of the patients also had polyps in their ear canals, and 13 (41%) had a convincing history of aspirin sensitivity. They also had viscous middle-ear effusions, which is why ear tubes don’t help.

In short, the researchers found that a history of asthma and nasal polyps should trigger investigation for EOM in adults with chronic, refractory ear pain.

Of 25 patients, 19 (76%) also had ear disease on CT scan, most commonly inner ear or mastoid opacification. Eighteen patients tested had eosinophilic cationic protein levels above 1,000 ng/mL in their middle-ear effusions, which is high, and 12 out of 30 (40%) were markedly eosinophilic on CBC. The average age of EOM onset was 55.5 years. There were 17 women and 15 men in the cohort.

There was some degree of bilateral hearing loss in nearly every patient, generally a mix of conductive and sensorineural deficits.

“A lot of them start off with conductive hearing loss and progress to sensorineural hearing loss, which can be permanent,” Dr. Willits said. “That’s the biggest thing I want people to recognize: If you start to work with an ENT to try to [identify and] treat these patients, you hopefully can prevent hearing loss.”

Many patients have a robust response to pegylated interferon-alpha. “It kind of dries up their ears, and they feel better,” Dr. Willits noted. Usually it’s given every 2-4 weeks, but some patients can get away with every 6 weeks and lower doses. The side effects are rough, however, and symptoms come back if it’s stopped. It’s also hard to get insurance companies to cover it for EOM (Laryngoscope. 2016 Sep 26. doi: 10.1002/lary.26303).

“It’s not a great treatment, but it’s about all we have,” she said. Omalizumab (Xolair) “has been tried, but it doesn’t help a lot of patients. We are hopeful some of these newer biologics” – such as dupilumab or mepolizumab (Nucala) – “will give these patients relief.”

Dr. Willits had no relevant disclosures.

[email protected]

 

ATLANTA – About a third to half of patients who test negative for penicillin allergies and have the label removed from their charts will, somewhere down the line, be relabeled as penicillin allergic.

It’s a vexing problem for the increasing number of patients who undergo confirmatory skin testing for penicillin sensitivity while in hospital. It’s become clear in recent years that at least 90% of people who say they have a penicillin allergy don’t really have one. Without confirmatory testing, they end up on expensive, second-line antibiotics, and don’t do well.

It’s unclear why people are relabeled after negative tests. Maybe patients don’t trust the results. Maybe doctors don’t hear about them or err on the side of caution despite negative testing. “I suspect it’s a combination of patient and provider factors,” said Sheenal Patel, MD, an allergy and immunology fellow at the University of Texas Southwestern Medical Center, Dallas.

Whatever the reason, UT Southwestern has taken steps over the past few years to make sure negative test results stick in patients’ records, he said at the annual meeting of the American Academy of Allergy, Asthma, and Immunology.

First, the time and place of negative tests were documented in the EHR, primary care providers were notified of the results, and pharmacists counseled patients at the time of negative testing to make sure they understood the results.

Next, pharmacists began to counsel patients after discharge to reaffirm the message, either face to face or over the phone. The center added an alert to the EHR that pops up if someone tries to relabel a patient and it notifies the pharmacists running the penicillin allergy testing program that an attempt was made. They call the patient’s primary care provider to find out what’s going on.

As of late, patients go home with a wallet card that documents their negative test results, to show providers who aren’t on the UT Southwestern EHR system, and family members.

It’s all made a difference. Only 31 of 225 (13.8%) were relabeled in a review presented by Dr. Patel. All 225 patients had at least 90 days of postdischarge follow-up in the UT Southwestern EHR system.

Rates of relabeling varied according to the specific intervention. Five of 27 (18.5%) who had only pharmacist counseling at the time of negative testing, documentation of negative results in the EHR, and the alert added to their electronic record were relabeled, versus just 1 of 15 patients (6.7%) who received all of the interventions, including pre- and postdischarge counseling and the wallet card. The relabel rate was 14.3% (14) among the 98 patients counseled by a pharmacist when they tested negative, with the results documented in their electronic record – the largest patient subset in the study.

Given the small numbers, it’s hard to know which intervention gave the most bang for the buck, but “pharmacist counseling and EHR documentation had clear benefit.” Postdischarge counseling, EHR alerts, and the wallet cards probably helped, too, Dr. Patel said.

Older patients were more likely to be relabeled, but the trend didn’t reach significance (P = .07). The risk of relabeling was unrelated to race, gender, infection risk factors, number of drug allergies, allergy symptoms, or how long ago the alleged penicillin reaction occurred; most patients reported it was more than 20 years ago. About half of the relabels were on the outpatient side, almost a third in the ED, and the rest in a hospital.

The study didn’t address why they occurred. “Some patients who have had this label for 20 or 30 years will just say they are penicillin allergic despite all our counseling efforts, and whoever is reviewing their allergy list has to decide what to do with that. [Often,] they put it back in the chart. There’s a fear of penicillin allergy histories not only among patients, but also among many providers, and that contributes a lot to this,” Dr. Patel said.

There was no external funding for the work. Dr. Patel had no disclosures.
 

[email protected]

 

ATLANTA – About a third to half of patients who test negative for penicillin allergies and have the label removed from their charts will, somewhere down the line, be relabeled as penicillin allergic.

It’s a vexing problem for the increasing number of patients who undergo confirmatory skin testing for penicillin sensitivity while in hospital. It’s become clear in recent years that at least 90% of people who say they have a penicillin allergy don’t really have one. Without confirmatory testing, they end up on expensive, second-line antibiotics, and don’t do well.

It’s unclear why people are relabeled after negative tests. Maybe patients don’t trust the results. Maybe doctors don’t hear about them or err on the side of caution despite negative testing. “I suspect it’s a combination of patient and provider factors,” said Sheenal Patel, MD, an allergy and immunology fellow at the University of Texas Southwestern Medical Center, Dallas.

Whatever the reason, UT Southwestern has taken steps over the past few years to make sure negative test results stick in patients’ records, he said at the annual meeting of the American Academy of Allergy, Asthma, and Immunology.

First, the time and place of negative tests were documented in the EHR, primary care providers were notified of the results, and pharmacists counseled patients at the time of negative testing to make sure they understood the results.

Next, pharmacists began to counsel patients after discharge to reaffirm the message, either face to face or over the phone. The center added an alert to the EHR that pops up if someone tries to relabel a patient and it notifies the pharmacists running the penicillin allergy testing program that an attempt was made. They call the patient’s primary care provider to find out what’s going on.

As of late, patients go home with a wallet card that documents their negative test results, to show providers who aren’t on the UT Southwestern EHR system, and family members.

It’s all made a difference. Only 31 of 225 (13.8%) were relabeled in a review presented by Dr. Patel. All 225 patients had at least 90 days of postdischarge follow-up in the UT Southwestern EHR system.

Rates of relabeling varied according to the specific intervention. Five of 27 (18.5%) who had only pharmacist counseling at the time of negative testing, documentation of negative results in the EHR, and the alert added to their electronic record were relabeled, versus just 1 of 15 patients (6.7%) who received all of the interventions, including pre- and postdischarge counseling and the wallet card. The relabel rate was 14.3% (14) among the 98 patients counseled by a pharmacist when they tested negative, with the results documented in their electronic record – the largest patient subset in the study.

Given the small numbers, it’s hard to know which intervention gave the most bang for the buck, but “pharmacist counseling and EHR documentation had clear benefit.” Postdischarge counseling, EHR alerts, and the wallet cards probably helped, too, Dr. Patel said.

Older patients were more likely to be relabeled, but the trend didn’t reach significance (P = .07). The risk of relabeling was unrelated to race, gender, infection risk factors, number of drug allergies, allergy symptoms, or how long ago the alleged penicillin reaction occurred; most patients reported it was more than 20 years ago. About half of the relabels were on the outpatient side, almost a third in the ED, and the rest in a hospital.

The study didn’t address why they occurred. “Some patients who have had this label for 20 or 30 years will just say they are penicillin allergic despite all our counseling efforts, and whoever is reviewing their allergy list has to decide what to do with that. [Often,] they put it back in the chart. There’s a fear of penicillin allergy histories not only among patients, but also among many providers, and that contributes a lot to this,” Dr. Patel said.

There was no external funding for the work. Dr. Patel had no disclosures.
 

[email protected]

 

ATLANTA – About a third to half of patients who test negative for penicillin allergies and have the label removed from their charts will, somewhere down the line, be relabeled as penicillin allergic.

It’s a vexing problem for the increasing number of patients who undergo confirmatory skin testing for penicillin sensitivity while in hospital. It’s become clear in recent years that at least 90% of people who say they have a penicillin allergy don’t really have one. Without confirmatory testing, they end up on expensive, second-line antibiotics, and don’t do well.

It’s unclear why people are relabeled after negative tests. Maybe patients don’t trust the results. Maybe doctors don’t hear about them or err on the side of caution despite negative testing. “I suspect it’s a combination of patient and provider factors,” said Sheenal Patel, MD, an allergy and immunology fellow at the University of Texas Southwestern Medical Center, Dallas.

Whatever the reason, UT Southwestern has taken steps over the past few years to make sure negative test results stick in patients’ records, he said at the annual meeting of the American Academy of Allergy, Asthma, and Immunology.

First, the time and place of negative tests were documented in the EHR, primary care providers were notified of the results, and pharmacists counseled patients at the time of negative testing to make sure they understood the results.

Next, pharmacists began to counsel patients after discharge to reaffirm the message, either face to face or over the phone. The center added an alert to the EHR that pops up if someone tries to relabel a patient and it notifies the pharmacists running the penicillin allergy testing program that an attempt was made. They call the patient’s primary care provider to find out what’s going on.

As of late, patients go home with a wallet card that documents their negative test results, to show providers who aren’t on the UT Southwestern EHR system, and family members.

It’s all made a difference. Only 31 of 225 (13.8%) were relabeled in a review presented by Dr. Patel. All 225 patients had at least 90 days of postdischarge follow-up in the UT Southwestern EHR system.

Rates of relabeling varied according to the specific intervention. Five of 27 (18.5%) who had only pharmacist counseling at the time of negative testing, documentation of negative results in the EHR, and the alert added to their electronic record were relabeled, versus just 1 of 15 patients (6.7%) who received all of the interventions, including pre- and postdischarge counseling and the wallet card. The relabel rate was 14.3% (14) among the 98 patients counseled by a pharmacist when they tested negative, with the results documented in their electronic record – the largest patient subset in the study.

Given the small numbers, it’s hard to know which intervention gave the most bang for the buck, but “pharmacist counseling and EHR documentation had clear benefit.” Postdischarge counseling, EHR alerts, and the wallet cards probably helped, too, Dr. Patel said.

Older patients were more likely to be relabeled, but the trend didn’t reach significance (P = .07). The risk of relabeling was unrelated to race, gender, infection risk factors, number of drug allergies, allergy symptoms, or how long ago the alleged penicillin reaction occurred; most patients reported it was more than 20 years ago. About half of the relabels were on the outpatient side, almost a third in the ED, and the rest in a hospital.

The study didn’t address why they occurred. “Some patients who have had this label for 20 or 30 years will just say they are penicillin allergic despite all our counseling efforts, and whoever is reviewing their allergy list has to decide what to do with that. [Often,] they put it back in the chart. There’s a fear of penicillin allergy histories not only among patients, but also among many providers, and that contributes a lot to this,” Dr. Patel said.

There was no external funding for the work. Dr. Patel had no disclosures.
 

[email protected]

 

ATLANTA – With the help of a pharmacist and the electronic health records system, Rochester (N.Y.) General Hospital ruled out penicillin allergies in 47 of 50 adult inpatients, and successfully transitioned them from second-line antibiotics to less expensive and more effective beta-lactam options.

The hospital’s EHR system generated a daily list of patients with a history of penicillin allergy who were on second-line options – vancomycin, daptomycin, aztreonam, linezolid, or moxifloxacin – for infections that would be better treated with beta-lactam antibiotics. An infectious disease pharmacist reviewed their history; if reported penicillin reactions were limited to a nonspecific rash more than 5 years earlier or seemed to be IgE mediated, patients were skin-prick tested to see if they really were allergic. Almost all of the 47 patients who had negative tests were switched to either a penicillin-based regimen or a cephalosporin.

Two weeks after discharge on phone follow-up, just one reported a problem: a mild rash that cleared up when he finished his course.

Lead investigator Allison C. Ramsey, MD, an allergist at Rochester General, estimates the switch saved $780 per patient and close to $40,000 overall, much of it by avoiding the expense and time of infusing vancomycin, the antibiotic most of the patients were on before being switched. It also saved 23 hospital days; patients transitioned to oral antibiotics didn’t need to stick around to get an IV catheter placed and have home services arranged.

“We are not a major academic center, and have to prioritize what resources we have,” said Dr. Ramsey, who did most of the skin-prick tests. Triaging patients for testing based on antibiotic use is “a good way to start. We are getting this off the ground at our institution. I think it’s a good model for non-academic community hospitals,” like Rochester General, a 528-bed tertiary care center.

It’s no secret that penicillin allergies are extremely overdiagnosed, and that 90% or more of patients who carry the label – both inside and outside of hospitals – really aren’t allergic. Even so, patients are rarely tested to confirm the allergy, and instead end up on expensive second-line options that don’t work as well. They “wind up back in the hospital in a month,” Dr. Ramsey said.

The problem was a frequent topic of discussion at the American Academy of Allergy, Asthma and Immunology annual meeting, where she reported her findings. The Rochester General approach was of great interest to her audience, judging from the number of people who asked for more details after the presentation.

Most of the subjects were on the internal medicine service; the rest were surgery patients. Skin/soft tissue, bloodstream, respiratory, and intra-abdominal infections were the most common.

The investigators excluded patients with a history of severe allergic reactions, such as joint swelling or skin sloughing, as well as patients with a flat, itchy, non-urticarial rash after penicillin less than 5 years earlier. ICU patients were excluded due to consent issues.

Also for safety, the team did a one-time amoxicillin oral challenge before patients were switched to a cephalosporin.

An audience member said he’d heard of pushback on such efforts because patients are being moved to less expensive antibiotics, so hospitals won’t be able to bill as much.

Dr. Ramsey replied that Rochester General has been “extremely supportive of our efforts, because we have a good case for improving clinical outcomes with this program.” Meanwhile, the two infectious disease pharmacists at the hospital “have embraced this fully. It makes their job easier down the road because most of these patients are frequent fliers.”

Dr. Ramsey had no relevant financial disclosures.

[email protected]

 

ATLANTA – With the help of a pharmacist and the electronic health records system, Rochester (N.Y.) General Hospital ruled out penicillin allergies in 47 of 50 adult inpatients, and successfully transitioned them from second-line antibiotics to less expensive and more effective beta-lactam options.

The hospital’s EHR system generated a daily list of patients with a history of penicillin allergy who were on second-line options – vancomycin, daptomycin, aztreonam, linezolid, or moxifloxacin – for infections that would be better treated with beta-lactam antibiotics. An infectious disease pharmacist reviewed their history; if reported penicillin reactions were limited to a nonspecific rash more than 5 years earlier or seemed to be IgE mediated, patients were skin-prick tested to see if they really were allergic. Almost all of the 47 patients who had negative tests were switched to either a penicillin-based regimen or a cephalosporin.

Two weeks after discharge on phone follow-up, just one reported a problem: a mild rash that cleared up when he finished his course.

Lead investigator Allison C. Ramsey, MD, an allergist at Rochester General, estimates the switch saved $780 per patient and close to $40,000 overall, much of it by avoiding the expense and time of infusing vancomycin, the antibiotic most of the patients were on before being switched. It also saved 23 hospital days; patients transitioned to oral antibiotics didn’t need to stick around to get an IV catheter placed and have home services arranged.

“We are not a major academic center, and have to prioritize what resources we have,” said Dr. Ramsey, who did most of the skin-prick tests. Triaging patients for testing based on antibiotic use is “a good way to start. We are getting this off the ground at our institution. I think it’s a good model for non-academic community hospitals,” like Rochester General, a 528-bed tertiary care center.

It’s no secret that penicillin allergies are extremely overdiagnosed, and that 90% or more of patients who carry the label – both inside and outside of hospitals – really aren’t allergic. Even so, patients are rarely tested to confirm the allergy, and instead end up on expensive second-line options that don’t work as well. They “wind up back in the hospital in a month,” Dr. Ramsey said.

The problem was a frequent topic of discussion at the American Academy of Allergy, Asthma and Immunology annual meeting, where she reported her findings. The Rochester General approach was of great interest to her audience, judging from the number of people who asked for more details after the presentation.

Most of the subjects were on the internal medicine service; the rest were surgery patients. Skin/soft tissue, bloodstream, respiratory, and intra-abdominal infections were the most common.

The investigators excluded patients with a history of severe allergic reactions, such as joint swelling or skin sloughing, as well as patients with a flat, itchy, non-urticarial rash after penicillin less than 5 years earlier. ICU patients were excluded due to consent issues.

Also for safety, the team did a one-time amoxicillin oral challenge before patients were switched to a cephalosporin.

An audience member said he’d heard of pushback on such efforts because patients are being moved to less expensive antibiotics, so hospitals won’t be able to bill as much.

Dr. Ramsey replied that Rochester General has been “extremely supportive of our efforts, because we have a good case for improving clinical outcomes with this program.” Meanwhile, the two infectious disease pharmacists at the hospital “have embraced this fully. It makes their job easier down the road because most of these patients are frequent fliers.”

Dr. Ramsey had no relevant financial disclosures.

[email protected]

 

ATLANTA – With the help of a pharmacist and the electronic health records system, Rochester (N.Y.) General Hospital ruled out penicillin allergies in 47 of 50 adult inpatients, and successfully transitioned them from second-line antibiotics to less expensive and more effective beta-lactam options.

The hospital’s EHR system generated a daily list of patients with a history of penicillin allergy who were on second-line options – vancomycin, daptomycin, aztreonam, linezolid, or moxifloxacin – for infections that would be better treated with beta-lactam antibiotics. An infectious disease pharmacist reviewed their history; if reported penicillin reactions were limited to a nonspecific rash more than 5 years earlier or seemed to be IgE mediated, patients were skin-prick tested to see if they really were allergic. Almost all of the 47 patients who had negative tests were switched to either a penicillin-based regimen or a cephalosporin.

Two weeks after discharge on phone follow-up, just one reported a problem: a mild rash that cleared up when he finished his course.

Lead investigator Allison C. Ramsey, MD, an allergist at Rochester General, estimates the switch saved $780 per patient and close to $40,000 overall, much of it by avoiding the expense and time of infusing vancomycin, the antibiotic most of the patients were on before being switched. It also saved 23 hospital days; patients transitioned to oral antibiotics didn’t need to stick around to get an IV catheter placed and have home services arranged.

“We are not a major academic center, and have to prioritize what resources we have,” said Dr. Ramsey, who did most of the skin-prick tests. Triaging patients for testing based on antibiotic use is “a good way to start. We are getting this off the ground at our institution. I think it’s a good model for non-academic community hospitals,” like Rochester General, a 528-bed tertiary care center.

It’s no secret that penicillin allergies are extremely overdiagnosed, and that 90% or more of patients who carry the label – both inside and outside of hospitals – really aren’t allergic. Even so, patients are rarely tested to confirm the allergy, and instead end up on expensive second-line options that don’t work as well. They “wind up back in the hospital in a month,” Dr. Ramsey said.

The problem was a frequent topic of discussion at the American Academy of Allergy, Asthma and Immunology annual meeting, where she reported her findings. The Rochester General approach was of great interest to her audience, judging from the number of people who asked for more details after the presentation.

Most of the subjects were on the internal medicine service; the rest were surgery patients. Skin/soft tissue, bloodstream, respiratory, and intra-abdominal infections were the most common.

The investigators excluded patients with a history of severe allergic reactions, such as joint swelling or skin sloughing, as well as patients with a flat, itchy, non-urticarial rash after penicillin less than 5 years earlier. ICU patients were excluded due to consent issues.

Also for safety, the team did a one-time amoxicillin oral challenge before patients were switched to a cephalosporin.

An audience member said he’d heard of pushback on such efforts because patients are being moved to less expensive antibiotics, so hospitals won’t be able to bill as much.

Dr. Ramsey replied that Rochester General has been “extremely supportive of our efforts, because we have a good case for improving clinical outcomes with this program.” Meanwhile, the two infectious disease pharmacists at the hospital “have embraced this fully. It makes their job easier down the road because most of these patients are frequent fliers.”

Dr. Ramsey had no relevant financial disclosures.

[email protected]

 

ATLANTA – Oral immunotherapy with wheat gluten flour decreased wheat reactions in some allergic patients, according to a trial reported at the annual meeting of the American Academy of Allergy, Asthma, and Immunology.

Wheat allergy is fairly common in young children; most people outgrow it. For some, though, it remains a dangerous problem, especially because wheat is almost impossible to avoid, said senior investigator Hugh Sampson, MD, the Kurt Hirschhorn Professor of Pediatrics at the Icahn School of Medicine at Mount Sinai and director of the Jaffe Food Allergy Institute at Mount Sinai Hospital, New York.

For example, one of the study subjects stopped for a bite on the way to the clinic. “He thought he ate a wheat-free breakfast but ended up arriving with anaphylaxis,” the physician said.

Dr. Sampson and his team randomized 23 wheat-allergic patients to daily doses of wheat gluten flour, escalated up every other week to a maximum of 1,445 mg/day; 23 other patients were randomized to placebo. The subjects were aged 4-22 years (median, 9 years), with positive wheat skin test results. At baseline, they could tolerate a median dose of only 43 mg.

Gluten is the protein-rich allergenic part of wheat; using gluten flour instead of regular flour allowed for smaller, more convenient doses. It was sprinkled over applesauce and other foods. Twelve of the 23 gluten flour subjects (52%), but no one in the placebo group, tolerated a challenge of 4,443 mg at 1 year.

Next, placebo subjects were started on their own gluten flour regimen, but they shot for a higher maximum dose of 3,870 mg/day. The original gluten group stayed on their dose, a maximum of 1,445 mg/day.

The higher dose was more effective at 2-year follow-up; 7 of 23 patients (30%) in the 1,445-mg group tolerated a challenge of 7,443 mg at 2 years, versus 12 of 21 patients (57%) in the 3,870-mg group.

Just over 10% of the doses triggered adverse reactions. Most of the reactions were mild – itching in the throat or mouth, nausea, and the like – but epinephrine was needed after 0.05% of the doses. The adverse reaction rate was similar to that with other forms of oral immunotherapy, and there were no statistically significant differences in the number of reactions between the low- and high-dose gluten groups.

For anyone who reads the study and thinks about running to the grocery store for gluten flour, Dr. Sampson cautioned against it. There’s no Food and Drug Administration–approved product, and, more importantly, “you can run into [serious medical] problems” if, for instance, immunotherapy triggers anaphylaxis with too much exercise afterward.

The study “has nothing to do with” the kind of gluten intolerance that’s led to an explosion in gluten-free products in recent years, he said. “Our study was directed at IgE-mediated reactions. Celiac disease has a very different mechanism.”

Also, only a few people remained tolerant after being backed off wheat immunotherapy for a couple of months. There’s no such thing as a cure for food allergies at this point.

“We are trying to get people into remission. Nobody yet has demonstrated that you can make a permanent change in somebody [who] is hypersensitive, even to a bee sting,” Dr. Sampson said.

The study results are big enough to protect wheat-allergic people from accidental exposure. In the case of the study subject who reacted to wheat in his breakfast, he probably reacted to far less than 7,443 mg of wheat protein – about the amount in a plate of pasta – before immunotherapy. No one with a wheat allergy is intentionally going to order something like that, Dr. Sampson said.

The next step is industry funding for a larger trial. “These studies are expensive, and we hope somebody will take up the torch. We have to get industry involved,” he said.

Private philanthropies funded the work. Dr. Sampson is chief scientific officer for DBV Technologies, a company developing a patch for peanut allergies.
 

[email protected]

 

ATLANTA – Oral immunotherapy with wheat gluten flour decreased wheat reactions in some allergic patients, according to a trial reported at the annual meeting of the American Academy of Allergy, Asthma, and Immunology.

Wheat allergy is fairly common in young children; most people outgrow it. For some, though, it remains a dangerous problem, especially because wheat is almost impossible to avoid, said senior investigator Hugh Sampson, MD, the Kurt Hirschhorn Professor of Pediatrics at the Icahn School of Medicine at Mount Sinai and director of the Jaffe Food Allergy Institute at Mount Sinai Hospital, New York.

For example, one of the study subjects stopped for a bite on the way to the clinic. “He thought he ate a wheat-free breakfast but ended up arriving with anaphylaxis,” the physician said.

Dr. Sampson and his team randomized 23 wheat-allergic patients to daily doses of wheat gluten flour, escalated up every other week to a maximum of 1,445 mg/day; 23 other patients were randomized to placebo. The subjects were aged 4-22 years (median, 9 years), with positive wheat skin test results. At baseline, they could tolerate a median dose of only 43 mg.

Gluten is the protein-rich allergenic part of wheat; using gluten flour instead of regular flour allowed for smaller, more convenient doses. It was sprinkled over applesauce and other foods. Twelve of the 23 gluten flour subjects (52%), but no one in the placebo group, tolerated a challenge of 4,443 mg at 1 year.

Next, placebo subjects were started on their own gluten flour regimen, but they shot for a higher maximum dose of 3,870 mg/day. The original gluten group stayed on their dose, a maximum of 1,445 mg/day.

The higher dose was more effective at 2-year follow-up; 7 of 23 patients (30%) in the 1,445-mg group tolerated a challenge of 7,443 mg at 2 years, versus 12 of 21 patients (57%) in the 3,870-mg group.

Just over 10% of the doses triggered adverse reactions. Most of the reactions were mild – itching in the throat or mouth, nausea, and the like – but epinephrine was needed after 0.05% of the doses. The adverse reaction rate was similar to that with other forms of oral immunotherapy, and there were no statistically significant differences in the number of reactions between the low- and high-dose gluten groups.

For anyone who reads the study and thinks about running to the grocery store for gluten flour, Dr. Sampson cautioned against it. There’s no Food and Drug Administration–approved product, and, more importantly, “you can run into [serious medical] problems” if, for instance, immunotherapy triggers anaphylaxis with too much exercise afterward.

The study “has nothing to do with” the kind of gluten intolerance that’s led to an explosion in gluten-free products in recent years, he said. “Our study was directed at IgE-mediated reactions. Celiac disease has a very different mechanism.”

Also, only a few people remained tolerant after being backed off wheat immunotherapy for a couple of months. There’s no such thing as a cure for food allergies at this point.

“We are trying to get people into remission. Nobody yet has demonstrated that you can make a permanent change in somebody [who] is hypersensitive, even to a bee sting,” Dr. Sampson said.

The study results are big enough to protect wheat-allergic people from accidental exposure. In the case of the study subject who reacted to wheat in his breakfast, he probably reacted to far less than 7,443 mg of wheat protein – about the amount in a plate of pasta – before immunotherapy. No one with a wheat allergy is intentionally going to order something like that, Dr. Sampson said.

The next step is industry funding for a larger trial. “These studies are expensive, and we hope somebody will take up the torch. We have to get industry involved,” he said.

Private philanthropies funded the work. Dr. Sampson is chief scientific officer for DBV Technologies, a company developing a patch for peanut allergies.
 

[email protected]

 

ATLANTA – Oral immunotherapy with wheat gluten flour decreased wheat reactions in some allergic patients, according to a trial reported at the annual meeting of the American Academy of Allergy, Asthma, and Immunology.

Wheat allergy is fairly common in young children; most people outgrow it. For some, though, it remains a dangerous problem, especially because wheat is almost impossible to avoid, said senior investigator Hugh Sampson, MD, the Kurt Hirschhorn Professor of Pediatrics at the Icahn School of Medicine at Mount Sinai and director of the Jaffe Food Allergy Institute at Mount Sinai Hospital, New York.

For example, one of the study subjects stopped for a bite on the way to the clinic. “He thought he ate a wheat-free breakfast but ended up arriving with anaphylaxis,” the physician said.

Dr. Sampson and his team randomized 23 wheat-allergic patients to daily doses of wheat gluten flour, escalated up every other week to a maximum of 1,445 mg/day; 23 other patients were randomized to placebo. The subjects were aged 4-22 years (median, 9 years), with positive wheat skin test results. At baseline, they could tolerate a median dose of only 43 mg.

Gluten is the protein-rich allergenic part of wheat; using gluten flour instead of regular flour allowed for smaller, more convenient doses. It was sprinkled over applesauce and other foods. Twelve of the 23 gluten flour subjects (52%), but no one in the placebo group, tolerated a challenge of 4,443 mg at 1 year.

Next, placebo subjects were started on their own gluten flour regimen, but they shot for a higher maximum dose of 3,870 mg/day. The original gluten group stayed on their dose, a maximum of 1,445 mg/day.

The higher dose was more effective at 2-year follow-up; 7 of 23 patients (30%) in the 1,445-mg group tolerated a challenge of 7,443 mg at 2 years, versus 12 of 21 patients (57%) in the 3,870-mg group.

Just over 10% of the doses triggered adverse reactions. Most of the reactions were mild – itching in the throat or mouth, nausea, and the like – but epinephrine was needed after 0.05% of the doses. The adverse reaction rate was similar to that with other forms of oral immunotherapy, and there were no statistically significant differences in the number of reactions between the low- and high-dose gluten groups.

For anyone who reads the study and thinks about running to the grocery store for gluten flour, Dr. Sampson cautioned against it. There’s no Food and Drug Administration–approved product, and, more importantly, “you can run into [serious medical] problems” if, for instance, immunotherapy triggers anaphylaxis with too much exercise afterward.

The study “has nothing to do with” the kind of gluten intolerance that’s led to an explosion in gluten-free products in recent years, he said. “Our study was directed at IgE-mediated reactions. Celiac disease has a very different mechanism.”

Also, only a few people remained tolerant after being backed off wheat immunotherapy for a couple of months. There’s no such thing as a cure for food allergies at this point.

“We are trying to get people into remission. Nobody yet has demonstrated that you can make a permanent change in somebody [who] is hypersensitive, even to a bee sting,” Dr. Sampson said.

The study results are big enough to protect wheat-allergic people from accidental exposure. In the case of the study subject who reacted to wheat in his breakfast, he probably reacted to far less than 7,443 mg of wheat protein – about the amount in a plate of pasta – before immunotherapy. No one with a wheat allergy is intentionally going to order something like that, Dr. Sampson said.

The next step is industry funding for a larger trial. “These studies are expensive, and we hope somebody will take up the torch. We have to get industry involved,” he said.

Private philanthropies funded the work. Dr. Sampson is chief scientific officer for DBV Technologies, a company developing a patch for peanut allergies.
 

[email protected]

 

ATLANTA – Four hours in the ED are enough to observe most children after anaphylaxis; if they are doing well, they don’t need to be admitted for longer observation, according to Children’s Hospital of Philadelphia investigators.

The right amount of time for observation after anaphylaxis has been debated for years. The current recommendation is 4-8 hours for both children and adults, but it’s a broad range, and some still argue for 24 hours. At least at the Children’s Hospital of Philadelphia (CHOP), much more than 4 hours means that patients need to be admitted to an inpatient floor, or a special extend-care ED unit.

The investigators said they thought that the 8-hour protocol in the ED might be unnecessary, especially after realizing that the CHOP allergy clinic sends kids home after 2.5 hours following suspected anaphylaxis, if they are otherwise fine.

In the fall of 2014, “we decided as a compromise not to go all the way down to 2.5 hours” in the ED, “but to stay within guidelines and go for 4 hours,” so long as kids don’t have asthma or need two epinephrine injections in the ED or have other risks for biphasic reactions, said lead investigator and pediatrician Juhee Lee, MD.

The overall admission rate for pediatric anaphylaxis fell from 58% (106/182) when 8-hour observation was the norm, to 24% (63/257) after ED physicians opted for 4-hour observation in 2014, a near 60% reduction.

Shorter observation was safe; 1% of patients (1/76) came back to the ED within 72 hours before the change, versus 3% (5/194) afterward, a statistically insignificant difference. None of the revisits in either cohort was for severe anaphylaxis symptoms.

“It was surprising to see how significantly we could reduce the admission rate. A 4-hour length of observation appears safe and could drastically improve ED patient flow and decrease hospitalization rates,” Dr. Lee said at the annual meeting of the American Academy of Allergy, Asthma, and Immunology.

About two-thirds of the ED visits in both groups were for food reactions, most commonly peanut and tree nut allergies.

The CHOP ED also changed how its clinicians treat anaphylaxis over the study period. Children used to get antihistamines and steroids in the ED, and were sent home with 5 days’ worth of both. They also left the ED with a prescription for epinephrine, but not an actual autoinjector.

Now, CHOP lets providers decide if children need antihistamines and steroids in the ED, and sends most home with an EpiPen.

Dr. Lee didn’t have any disclosures. There was no outside funding.

[email protected]

 

ATLANTA – Four hours in the ED are enough to observe most children after anaphylaxis; if they are doing well, they don’t need to be admitted for longer observation, according to Children’s Hospital of Philadelphia investigators.

The right amount of time for observation after anaphylaxis has been debated for years. The current recommendation is 4-8 hours for both children and adults, but it’s a broad range, and some still argue for 24 hours. At least at the Children’s Hospital of Philadelphia (CHOP), much more than 4 hours means that patients need to be admitted to an inpatient floor, or a special extend-care ED unit.

The investigators said they thought that the 8-hour protocol in the ED might be unnecessary, especially after realizing that the CHOP allergy clinic sends kids home after 2.5 hours following suspected anaphylaxis, if they are otherwise fine.

In the fall of 2014, “we decided as a compromise not to go all the way down to 2.5 hours” in the ED, “but to stay within guidelines and go for 4 hours,” so long as kids don’t have asthma or need two epinephrine injections in the ED or have other risks for biphasic reactions, said lead investigator and pediatrician Juhee Lee, MD.

The overall admission rate for pediatric anaphylaxis fell from 58% (106/182) when 8-hour observation was the norm, to 24% (63/257) after ED physicians opted for 4-hour observation in 2014, a near 60% reduction.

Shorter observation was safe; 1% of patients (1/76) came back to the ED within 72 hours before the change, versus 3% (5/194) afterward, a statistically insignificant difference. None of the revisits in either cohort was for severe anaphylaxis symptoms.

“It was surprising to see how significantly we could reduce the admission rate. A 4-hour length of observation appears safe and could drastically improve ED patient flow and decrease hospitalization rates,” Dr. Lee said at the annual meeting of the American Academy of Allergy, Asthma, and Immunology.

About two-thirds of the ED visits in both groups were for food reactions, most commonly peanut and tree nut allergies.

The CHOP ED also changed how its clinicians treat anaphylaxis over the study period. Children used to get antihistamines and steroids in the ED, and were sent home with 5 days’ worth of both. They also left the ED with a prescription for epinephrine, but not an actual autoinjector.

Now, CHOP lets providers decide if children need antihistamines and steroids in the ED, and sends most home with an EpiPen.

Dr. Lee didn’t have any disclosures. There was no outside funding.

[email protected]

 

ATLANTA – Four hours in the ED are enough to observe most children after anaphylaxis; if they are doing well, they don’t need to be admitted for longer observation, according to Children’s Hospital of Philadelphia investigators.

The right amount of time for observation after anaphylaxis has been debated for years. The current recommendation is 4-8 hours for both children and adults, but it’s a broad range, and some still argue for 24 hours. At least at the Children’s Hospital of Philadelphia (CHOP), much more than 4 hours means that patients need to be admitted to an inpatient floor, or a special extend-care ED unit.

The investigators said they thought that the 8-hour protocol in the ED might be unnecessary, especially after realizing that the CHOP allergy clinic sends kids home after 2.5 hours following suspected anaphylaxis, if they are otherwise fine.

In the fall of 2014, “we decided as a compromise not to go all the way down to 2.5 hours” in the ED, “but to stay within guidelines and go for 4 hours,” so long as kids don’t have asthma or need two epinephrine injections in the ED or have other risks for biphasic reactions, said lead investigator and pediatrician Juhee Lee, MD.

The overall admission rate for pediatric anaphylaxis fell from 58% (106/182) when 8-hour observation was the norm, to 24% (63/257) after ED physicians opted for 4-hour observation in 2014, a near 60% reduction.

Shorter observation was safe; 1% of patients (1/76) came back to the ED within 72 hours before the change, versus 3% (5/194) afterward, a statistically insignificant difference. None of the revisits in either cohort was for severe anaphylaxis symptoms.

“It was surprising to see how significantly we could reduce the admission rate. A 4-hour length of observation appears safe and could drastically improve ED patient flow and decrease hospitalization rates,” Dr. Lee said at the annual meeting of the American Academy of Allergy, Asthma, and Immunology.

About two-thirds of the ED visits in both groups were for food reactions, most commonly peanut and tree nut allergies.

The CHOP ED also changed how its clinicians treat anaphylaxis over the study period. Children used to get antihistamines and steroids in the ED, and were sent home with 5 days’ worth of both. They also left the ED with a prescription for epinephrine, but not an actual autoinjector.

Now, CHOP lets providers decide if children need antihistamines and steroids in the ED, and sends most home with an EpiPen.

Dr. Lee didn’t have any disclosures. There was no outside funding.

[email protected]

ATLANTA – Systemic reactions against subcutaneous allergen immunotherapy have trended down overall in recent years, but there has been an uptick in reports of severe grade 4 reactions for reasons that are not yet clear, according to a review of 46.6 million injection office visits from 2008-2015.

The data come from annual surveys of members of the American Academy of Allergy, Asthma, and Immunology and of the American College of Allergy, Asthma, and Immunology, of whom 27%-51% responded each year.

There were also no infections reported for 9.5 million injection visits, and just two grade 3 reactions among 1,355 sublingual allergen immunotherapy patients, both of whom were treated successfully with epinephrine.

However, on surveys from 2013 to 2015, one grade 4 reaction – hypotension or respiratory failure – was reported for every 160,000 injection visits, up from one per million office visits in previous years. Two-thirds (152/252) of grade 3/4 systemic reactions (SRs) for 2014-2015 occurred in asthmatics. Among the three fatalities directly linked to allergy shots since 2008, all of them occurred in adults; two patients had asthma. The findings highlight the need for good asthma control before shots begin, with a forced expiratory volume of at least 70% in 1 second (J Allergy Clin Immunol. 2017 Feb;139[2]:AB377).

“Asthma remains a major risk factor for severe SRs... [It’s something] allergists need to be vigilant about,” said lead investigator Tolly Epstein, MD, an assistant professor of immunology at the University of Cincinnati.

It’s unclear if there has been a true increase in severe reactions, or simply better reporting of them since the reaction grading system started being used a few years ago. “I was surprised a little bit to see the uptick in severe systemic reactions, but I am not sure if it’s real yet,” Dr. Epstein said. She and her colleagues are collecting more data on the reports of severe reactions.

Dr. Epstein and her colleagues found in previous work that higher maintenance doses may increase the risk of SRs. The right balance between efficacy and safety is still being worked out, she said at the annual meeting of the American Academy of Allergy, Asthma, and Immunology.

The surveys started collecting data on infections from allergy shots in 2014, amid concerns about contaminants in compounded medications. The fact that none were reported probably isn’t a surprise to allergists, but it might be news to others who have raised concerns about the possibility, Dr. Epstein said.

Overall safety was good for sublingual allergen immunotherapy, first approved by the Food and Drug Administration in 2014. One of the grade 3 reactions was pharyngeal edema; the other involved throat tightening and lower respiratory symptoms.

One of the asthma patients who died was morbidly obese and under treatment for weed allergies during pollen season, and died from overwhelming laryngeal edema. The patient’s weight made IV access difficult. The other asthma patient had severe disease, and was on the maximum dose of fluticasone/salmeterol. He was on an accelerated buildup for dust mites, pollen, mold, and other allergies, and apparently died of asthma complications triggered by the shots. There were no known risk factors in the third death.

Mortalities are lower than they used to be in the past with allergy shots, Dr. Epstein said.

She said she had no relevant disclosures.

[email protected]

ATLANTA – Systemic reactions against subcutaneous allergen immunotherapy have trended down overall in recent years, but there has been an uptick in reports of severe grade 4 reactions for reasons that are not yet clear, according to a review of 46.6 million injection office visits from 2008-2015.

The data come from annual surveys of members of the American Academy of Allergy, Asthma, and Immunology and of the American College of Allergy, Asthma, and Immunology, of whom 27%-51% responded each year.

There were also no infections reported for 9.5 million injection visits, and just two grade 3 reactions among 1,355 sublingual allergen immunotherapy patients, both of whom were treated successfully with epinephrine.

However, on surveys from 2013 to 2015, one grade 4 reaction – hypotension or respiratory failure – was reported for every 160,000 injection visits, up from one per million office visits in previous years. Two-thirds (152/252) of grade 3/4 systemic reactions (SRs) for 2014-2015 occurred in asthmatics. Among the three fatalities directly linked to allergy shots since 2008, all of them occurred in adults; two patients had asthma. The findings highlight the need for good asthma control before shots begin, with a forced expiratory volume of at least 70% in 1 second (J Allergy Clin Immunol. 2017 Feb;139[2]:AB377).

“Asthma remains a major risk factor for severe SRs... [It’s something] allergists need to be vigilant about,” said lead investigator Tolly Epstein, MD, an assistant professor of immunology at the University of Cincinnati.

It’s unclear if there has been a true increase in severe reactions, or simply better reporting of them since the reaction grading system started being used a few years ago. “I was surprised a little bit to see the uptick in severe systemic reactions, but I am not sure if it’s real yet,” Dr. Epstein said. She and her colleagues are collecting more data on the reports of severe reactions.

Dr. Epstein and her colleagues found in previous work that higher maintenance doses may increase the risk of SRs. The right balance between efficacy and safety is still being worked out, she said at the annual meeting of the American Academy of Allergy, Asthma, and Immunology.

The surveys started collecting data on infections from allergy shots in 2014, amid concerns about contaminants in compounded medications. The fact that none were reported probably isn’t a surprise to allergists, but it might be news to others who have raised concerns about the possibility, Dr. Epstein said.

Overall safety was good for sublingual allergen immunotherapy, first approved by the Food and Drug Administration in 2014. One of the grade 3 reactions was pharyngeal edema; the other involved throat tightening and lower respiratory symptoms.

One of the asthma patients who died was morbidly obese and under treatment for weed allergies during pollen season, and died from overwhelming laryngeal edema. The patient’s weight made IV access difficult. The other asthma patient had severe disease, and was on the maximum dose of fluticasone/salmeterol. He was on an accelerated buildup for dust mites, pollen, mold, and other allergies, and apparently died of asthma complications triggered by the shots. There were no known risk factors in the third death.

Mortalities are lower than they used to be in the past with allergy shots, Dr. Epstein said.

She said she had no relevant disclosures.

[email protected]

ATLANTA – Systemic reactions against subcutaneous allergen immunotherapy have trended down overall in recent years, but there has been an uptick in reports of severe grade 4 reactions for reasons that are not yet clear, according to a review of 46.6 million injection office visits from 2008-2015.

The data come from annual surveys of members of the American Academy of Allergy, Asthma, and Immunology and of the American College of Allergy, Asthma, and Immunology, of whom 27%-51% responded each year.

There were also no infections reported for 9.5 million injection visits, and just two grade 3 reactions among 1,355 sublingual allergen immunotherapy patients, both of whom were treated successfully with epinephrine.

However, on surveys from 2013 to 2015, one grade 4 reaction – hypotension or respiratory failure – was reported for every 160,000 injection visits, up from one per million office visits in previous years. Two-thirds (152/252) of grade 3/4 systemic reactions (SRs) for 2014-2015 occurred in asthmatics. Among the three fatalities directly linked to allergy shots since 2008, all of them occurred in adults; two patients had asthma. The findings highlight the need for good asthma control before shots begin, with a forced expiratory volume of at least 70% in 1 second (J Allergy Clin Immunol. 2017 Feb;139[2]:AB377).

“Asthma remains a major risk factor for severe SRs... [It’s something] allergists need to be vigilant about,” said lead investigator Tolly Epstein, MD, an assistant professor of immunology at the University of Cincinnati.

It’s unclear if there has been a true increase in severe reactions, or simply better reporting of them since the reaction grading system started being used a few years ago. “I was surprised a little bit to see the uptick in severe systemic reactions, but I am not sure if it’s real yet,” Dr. Epstein said. She and her colleagues are collecting more data on the reports of severe reactions.

Dr. Epstein and her colleagues found in previous work that higher maintenance doses may increase the risk of SRs. The right balance between efficacy and safety is still being worked out, she said at the annual meeting of the American Academy of Allergy, Asthma, and Immunology.

The surveys started collecting data on infections from allergy shots in 2014, amid concerns about contaminants in compounded medications. The fact that none were reported probably isn’t a surprise to allergists, but it might be news to others who have raised concerns about the possibility, Dr. Epstein said.

Overall safety was good for sublingual allergen immunotherapy, first approved by the Food and Drug Administration in 2014. One of the grade 3 reactions was pharyngeal edema; the other involved throat tightening and lower respiratory symptoms.

One of the asthma patients who died was morbidly obese and under treatment for weed allergies during pollen season, and died from overwhelming laryngeal edema. The patient’s weight made IV access difficult. The other asthma patient had severe disease, and was on the maximum dose of fluticasone/salmeterol. He was on an accelerated buildup for dust mites, pollen, mold, and other allergies, and apparently died of asthma complications triggered by the shots. There were no known risk factors in the third death.

Mortalities are lower than they used to be in the past with allergy shots, Dr. Epstein said.

She said she had no relevant disclosures.

[email protected]

SEATTLE – Bacterial vaginosis does not decrease the effectiveness of oral pre-exposure prophylaxis (PrEP) for HIV prevention, according to an investigation of 1,470 women in Africa.

Daily oral PrEP with tenofovir pills was 77% effective in protecting women with bacterial vaginosis from HIV, and 73% effective in women who did not have BV over the 3-year study. The difference was not statistically significant.

Daily oral PrEP is effective even with abnormal vaginal microbiota, lead investigator Renee Heffron, PhD, of the department of global health at the University of Washington, Seattle, and her colleagues concluded in a presentation of their findings at the Conference on Retroviruses & Opportunistic Infections in partnership with the International Antiviral Society.

Bacterial vaginosis in PrEP has been a concern ever since it was reported in the summer of 2016 that vaginal tenofovir gel didn’t prevent HIV in women with the condition. “Our results provide reassurance ... We [saw] no evidence that oral PrEP effectiveness was reduced in East African women with Gram stain evidence of BV or vaginal dysbiosis. Oral PrEP delivery to women does not need to be accompanied by testing for BV,” Dr. Heffron said.

It’s likely that Gardnerella vaginalis degrades topical tenofovir when applied vaginally; oral administration bypasses the effect.

The findings come from a subanalysis of the Partners PrEP Study, a phase III trial of daily oral PrEP in Kenya and Uganda. The investigators broke out PrEP results according to BV status, with BV defined as a Nugent score of 7-10, assessed annually. Adherence was high in the 985 women randomized to PrEP, at about 80%.

There were 0.9 cases of newly acquired HIV per 100 person-years among women in the BV PrEP group, versus 3.5 per 100 person-years among BV women not on prep. PrEP was about 63% effective in women with intermediate Nugent scores of 4-6. The differences in HIV protection according to Nugent score were not statistically significant (P = .9).

It didn’t matter if women had Gardnerella, Bacteroides, or Lactobacillus morphotypes. All three are markers of abnormal vaginal microbiota, but PrEP still worked.

The median age in the study was 33 years, and 24% of the women had BV at baseline.

Dr. Heffron did not report any disclosures. The Gates Foundation and other sources funded the work.

[email protected]

SEATTLE – Bacterial vaginosis does not decrease the effectiveness of oral pre-exposure prophylaxis (PrEP) for HIV prevention, according to an investigation of 1,470 women in Africa.

Daily oral PrEP with tenofovir pills was 77% effective in protecting women with bacterial vaginosis from HIV, and 73% effective in women who did not have BV over the 3-year study. The difference was not statistically significant.

Daily oral PrEP is effective even with abnormal vaginal microbiota, lead investigator Renee Heffron, PhD, of the department of global health at the University of Washington, Seattle, and her colleagues concluded in a presentation of their findings at the Conference on Retroviruses & Opportunistic Infections in partnership with the International Antiviral Society.

Bacterial vaginosis in PrEP has been a concern ever since it was reported in the summer of 2016 that vaginal tenofovir gel didn’t prevent HIV in women with the condition. “Our results provide reassurance ... We [saw] no evidence that oral PrEP effectiveness was reduced in East African women with Gram stain evidence of BV or vaginal dysbiosis. Oral PrEP delivery to women does not need to be accompanied by testing for BV,” Dr. Heffron said.

It’s likely that Gardnerella vaginalis degrades topical tenofovir when applied vaginally; oral administration bypasses the effect.

The findings come from a subanalysis of the Partners PrEP Study, a phase III trial of daily oral PrEP in Kenya and Uganda. The investigators broke out PrEP results according to BV status, with BV defined as a Nugent score of 7-10, assessed annually. Adherence was high in the 985 women randomized to PrEP, at about 80%.

There were 0.9 cases of newly acquired HIV per 100 person-years among women in the BV PrEP group, versus 3.5 per 100 person-years among BV women not on prep. PrEP was about 63% effective in women with intermediate Nugent scores of 4-6. The differences in HIV protection according to Nugent score were not statistically significant (P = .9).

It didn’t matter if women had Gardnerella, Bacteroides, or Lactobacillus morphotypes. All three are markers of abnormal vaginal microbiota, but PrEP still worked.

The median age in the study was 33 years, and 24% of the women had BV at baseline.

Dr. Heffron did not report any disclosures. The Gates Foundation and other sources funded the work.

[email protected]

SEATTLE – Bacterial vaginosis does not decrease the effectiveness of oral pre-exposure prophylaxis (PrEP) for HIV prevention, according to an investigation of 1,470 women in Africa.

Daily oral PrEP with tenofovir pills was 77% effective in protecting women with bacterial vaginosis from HIV, and 73% effective in women who did not have BV over the 3-year study. The difference was not statistically significant.

Daily oral PrEP is effective even with abnormal vaginal microbiota, lead investigator Renee Heffron, PhD, of the department of global health at the University of Washington, Seattle, and her colleagues concluded in a presentation of their findings at the Conference on Retroviruses & Opportunistic Infections in partnership with the International Antiviral Society.

Bacterial vaginosis in PrEP has been a concern ever since it was reported in the summer of 2016 that vaginal tenofovir gel didn’t prevent HIV in women with the condition. “Our results provide reassurance ... We [saw] no evidence that oral PrEP effectiveness was reduced in East African women with Gram stain evidence of BV or vaginal dysbiosis. Oral PrEP delivery to women does not need to be accompanied by testing for BV,” Dr. Heffron said.

It’s likely that Gardnerella vaginalis degrades topical tenofovir when applied vaginally; oral administration bypasses the effect.

The findings come from a subanalysis of the Partners PrEP Study, a phase III trial of daily oral PrEP in Kenya and Uganda. The investigators broke out PrEP results according to BV status, with BV defined as a Nugent score of 7-10, assessed annually. Adherence was high in the 985 women randomized to PrEP, at about 80%.

There were 0.9 cases of newly acquired HIV per 100 person-years among women in the BV PrEP group, versus 3.5 per 100 person-years among BV women not on prep. PrEP was about 63% effective in women with intermediate Nugent scores of 4-6. The differences in HIV protection according to Nugent score were not statistically significant (P = .9).

It didn’t matter if women had Gardnerella, Bacteroides, or Lactobacillus morphotypes. All three are markers of abnormal vaginal microbiota, but PrEP still worked.

The median age in the study was 33 years, and 24% of the women had BV at baseline.

Dr. Heffron did not report any disclosures. The Gates Foundation and other sources funded the work.

[email protected]

SEATTLE – Neurologic symptoms are an unreliable indicator of neurosyphilis in patients with HIV, according to University of Washington, Seattle, investigators.

After tapping 385 HIV patients with untreated syphilis and possible central nervous system involvement, “the bottom line was that [symptom] sensitivity was so low that not having [symptoms] really shouldn’t reassure you. If you are concerned that your patient could have neurosyphilis because of other factors” – such as an especially high rapid plasma reagin titer or low CD4 count – “you still need to tap them,” said lead investigator Arielle P. Davis, MD, who is in the department of neurology at the university.

It’s an important finding because the Centers for Disease Control and Prevention currently recommends lumbar punctures when patients have neurologic symptoms, and some people wait for them before tapping. The University of Washington team found that there can be neurologic involvement even without symptoms.

In the prospective study, symptoms were simply not sensitive enough to rule anything out. Moderate or greater photophobia had a sensitivity of 6.3% for a reactive cerebrospinal fluid Venereal Disease Research Laboratory (CSF-VDRL) syphilis test; moderate or greater vision loss was 38.1% sensitive for reactive CSF-VDRL, moderate or greater hearing loss was 13.2% sensitive, and moderate or greater gait incoordination was 1.5% sensitive.

Specificity was markedly better for each of those symptoms, and more than 95% for moderate or greater photophobia, hearing loss, and gait incoordination. “In general, as the severity of photophobia, vision loss, hearing loss, and gait incoordination increased, the specificity increased, but at the expense of sensitivity,” the investigators wrote in their poster, which Dr. Davis presented at the Conference on Retroviruses & Opportunistic Infections in partnership with the International Antiviral Society.

CSF-VDRL was reactive in 68 subjects (18%). The odds of a reactive CSF-VDRL were significantly higher in patients with vision loss (odds ratio, 2.2; 95% confidence interval, 1.2-4.0; P = .01) and trended toward significance in those with moderate or greater hearing loss (OR, 2.5; 95% CI, 1.0-6.6; P = .06).

Overall, “patients with mild or greater photophobia, vision loss, gait incoordination, and moderate or greater hearing loss were significantly more likely to have a reactive CSF-VDRL, and the presence of any of these four symptoms should [remain] a criterion for pursuing a lumbar puncture.” However, “lack of neurologic symptoms in HIV-infected patients with syphilis should not reassure clinicians that their patients do not have neurosyphilis,” Dr. Davis and her team concluded.

The participants were almost entirely men and mostly white. The average age was about 40 years, and the median rapid plasma reagin titer was 1:64. About 48% of the subjects reported at least mild vision loss, 40% reported mild or worse headache, and 17% reported some degree of hearing loss. Overall, 15.5%-17.2% reported at least mild photophobia, stiff neck, or gait incoordination.

The work was funded by the National Institutes of Health. Dr. Davis did not have any relevant disclosures.

[email protected]

SEATTLE – Neurologic symptoms are an unreliable indicator of neurosyphilis in patients with HIV, according to University of Washington, Seattle, investigators.

After tapping 385 HIV patients with untreated syphilis and possible central nervous system involvement, “the bottom line was that [symptom] sensitivity was so low that not having [symptoms] really shouldn’t reassure you. If you are concerned that your patient could have neurosyphilis because of other factors” – such as an especially high rapid plasma reagin titer or low CD4 count – “you still need to tap them,” said lead investigator Arielle P. Davis, MD, who is in the department of neurology at the university.

It’s an important finding because the Centers for Disease Control and Prevention currently recommends lumbar punctures when patients have neurologic symptoms, and some people wait for them before tapping. The University of Washington team found that there can be neurologic involvement even without symptoms.

In the prospective study, symptoms were simply not sensitive enough to rule anything out. Moderate or greater photophobia had a sensitivity of 6.3% for a reactive cerebrospinal fluid Venereal Disease Research Laboratory (CSF-VDRL) syphilis test; moderate or greater vision loss was 38.1% sensitive for reactive CSF-VDRL, moderate or greater hearing loss was 13.2% sensitive, and moderate or greater gait incoordination was 1.5% sensitive.

Specificity was markedly better for each of those symptoms, and more than 95% for moderate or greater photophobia, hearing loss, and gait incoordination. “In general, as the severity of photophobia, vision loss, hearing loss, and gait incoordination increased, the specificity increased, but at the expense of sensitivity,” the investigators wrote in their poster, which Dr. Davis presented at the Conference on Retroviruses & Opportunistic Infections in partnership with the International Antiviral Society.

CSF-VDRL was reactive in 68 subjects (18%). The odds of a reactive CSF-VDRL were significantly higher in patients with vision loss (odds ratio, 2.2; 95% confidence interval, 1.2-4.0; P = .01) and trended toward significance in those with moderate or greater hearing loss (OR, 2.5; 95% CI, 1.0-6.6; P = .06).

Overall, “patients with mild or greater photophobia, vision loss, gait incoordination, and moderate or greater hearing loss were significantly more likely to have a reactive CSF-VDRL, and the presence of any of these four symptoms should [remain] a criterion for pursuing a lumbar puncture.” However, “lack of neurologic symptoms in HIV-infected patients with syphilis should not reassure clinicians that their patients do not have neurosyphilis,” Dr. Davis and her team concluded.

The participants were almost entirely men and mostly white. The average age was about 40 years, and the median rapid plasma reagin titer was 1:64. About 48% of the subjects reported at least mild vision loss, 40% reported mild or worse headache, and 17% reported some degree of hearing loss. Overall, 15.5%-17.2% reported at least mild photophobia, stiff neck, or gait incoordination.

The work was funded by the National Institutes of Health. Dr. Davis did not have any relevant disclosures.

[email protected]

SEATTLE – Neurologic symptoms are an unreliable indicator of neurosyphilis in patients with HIV, according to University of Washington, Seattle, investigators.

After tapping 385 HIV patients with untreated syphilis and possible central nervous system involvement, “the bottom line was that [symptom] sensitivity was so low that not having [symptoms] really shouldn’t reassure you. If you are concerned that your patient could have neurosyphilis because of other factors” – such as an especially high rapid plasma reagin titer or low CD4 count – “you still need to tap them,” said lead investigator Arielle P. Davis, MD, who is in the department of neurology at the university.

It’s an important finding because the Centers for Disease Control and Prevention currently recommends lumbar punctures when patients have neurologic symptoms, and some people wait for them before tapping. The University of Washington team found that there can be neurologic involvement even without symptoms.

In the prospective study, symptoms were simply not sensitive enough to rule anything out. Moderate or greater photophobia had a sensitivity of 6.3% for a reactive cerebrospinal fluid Venereal Disease Research Laboratory (CSF-VDRL) syphilis test; moderate or greater vision loss was 38.1% sensitive for reactive CSF-VDRL, moderate or greater hearing loss was 13.2% sensitive, and moderate or greater gait incoordination was 1.5% sensitive.

Specificity was markedly better for each of those symptoms, and more than 95% for moderate or greater photophobia, hearing loss, and gait incoordination. “In general, as the severity of photophobia, vision loss, hearing loss, and gait incoordination increased, the specificity increased, but at the expense of sensitivity,” the investigators wrote in their poster, which Dr. Davis presented at the Conference on Retroviruses & Opportunistic Infections in partnership with the International Antiviral Society.

CSF-VDRL was reactive in 68 subjects (18%). The odds of a reactive CSF-VDRL were significantly higher in patients with vision loss (odds ratio, 2.2; 95% confidence interval, 1.2-4.0; P = .01) and trended toward significance in those with moderate or greater hearing loss (OR, 2.5; 95% CI, 1.0-6.6; P = .06).

Overall, “patients with mild or greater photophobia, vision loss, gait incoordination, and moderate or greater hearing loss were significantly more likely to have a reactive CSF-VDRL, and the presence of any of these four symptoms should [remain] a criterion for pursuing a lumbar puncture.” However, “lack of neurologic symptoms in HIV-infected patients with syphilis should not reassure clinicians that their patients do not have neurosyphilis,” Dr. Davis and her team concluded.

The participants were almost entirely men and mostly white. The average age was about 40 years, and the median rapid plasma reagin titer was 1:64. About 48% of the subjects reported at least mild vision loss, 40% reported mild or worse headache, and 17% reported some degree of hearing loss. Overall, 15.5%-17.2% reported at least mild photophobia, stiff neck, or gait incoordination.

The work was funded by the National Institutes of Health. Dr. Davis did not have any relevant disclosures.

[email protected]