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M. Alexander Otto began his reporting career early in 1999 covering the pharmaceutical industry for a national pharmacists' magazine and freelancing for the Washington Post and other newspapers. He then joined BNA, now part of Bloomberg News, covering health law and the protection of people and animals in medical research. Alex next worked for the McClatchy Company. Based on his work, Alex won a year-long Knight Science Journalism Fellowship to MIT in 2008-2009. He joined the company shortly thereafter. Alex has a newspaper journalism degree from Syracuse (N.Y.) University and a master's degree in medical science -- a physician assistant degree -- from George Washington University. Alex is based in Seattle.
Liquid biopsy detects gynecologic CA recurrence earlier than CT, CA-125
SAN DIEGO – Following chemotherapy and surgery for gynecologic cancer, circulating tumor DNA identified recurrence in six of 32 women a mean of 7 months before it was detected on CT scan, Dr. John Martignetti reported at the annual meeting of the Society of Gynecologic Oncology. “The CT scan did not pick up cancer that ctDNA [circulating tumor DNA] did.” Meanwhile, while essentially every patient had detectable ctDNA when tumor was present on CT, only about 60% had elevated cancer antigen 125 (CA-125) levels, said Dr. Martignetti of the Icahn School of Medicine at Mount Sinai, New York.
In a subgroup of 10 patients with known survival outcomes, five with no ctDNA after primary treatment had 22-33 months progression free survival, and all were alive at up to 5.4 years follow-up. Four of the five with ctDNA after primary treatment died within 29 months; the other patient progressed immediately and was alive with disease at 4.8 years.
“We demonstrated for the first time that personalized ctDNA biomarkers in gynecologic cancers can detect the presence of residual tumor earlier than currently used serum and imaging studies and are an independent predictor of survival. [They] dynamically predict treatment response and survival in gynecologic cancers. The measurement of ctDNA in blood – dubbed liquid biopsy – is “a powerful emerging technology capable of providing accurate assessment of both tumor behavior and disease burden,” Dr. Martignetti said.
“These mutations are only made in cancer cells,” so if they are in the blood, there must be cancer somewhere, he said.
The Sinai team identified specific mutations – in, for example, P53 tumor suppression, beta-catenin, or BRAF genes – in tumor cells from 36 of 44 women, using targeted sequencing for likely mutations in 28 samples and whole exome sequencing in eight. Blood samples were checked for ctDNA in 32 women by droplet digital PCR; ctDNA was detected in 30 (94%). The patients had high-grade endometrial carcinomas or high-grade serous carcinomas of the ovary, fallopian tube, or peritoneum.
For six women, ctDNA detected recurrence 1-11 months before CT. In once case, CA-125 was within normal limits a month before bowel resection for recurrence, and a PET scan 3 months before was negative. “Seven months before her surgery, we could detect ctDNA,” Dr. Martignetti said. For the rest of the women, sensitivity and specificity correlated with CA-125 and CT.
Mount Sinai has been working on ctDNA for almost a decade, and is among the pioneers in the field. Every gynecologic cancer patient there has tumor samples collected for sequencing and blood samples for ctDNA testing.
With ctDNA, “you can monitor the evolution of tumor growth, response to treatment, acquired resistance, and development of tumor heterogeneity.” If there’s no ctDNA, it seems likely “that patients can go home and say ‘whew.’ Lingering mutations” suggest the need for closer follow-up and perhaps additional chemotherapy.
The ultimate goal of liquid biopsy is to tailor cancer treatment to specific tumor mutations. Patients with fibroblast growth factor receptor (FGFR) gene mutations could get an FGFR inhibitor; ovarian tumors with lung cancer mutations might get lung cancer drugs. The approach is being tested by the National Institutes of Health through the NCI-MATCH trial.
It seems likely there’s also a role in screening. The Sinai team detected tumor DNA mutations in the uterine lavage fluid of a woman who presented with postmenopausal bleeding. A week later, pathology identified a microscopic stage 1, grade 1 endometrial cancer in situ. “That’s the future,” Dr. Martignetti said.
SAN DIEGO – Following chemotherapy and surgery for gynecologic cancer, circulating tumor DNA identified recurrence in six of 32 women a mean of 7 months before it was detected on CT scan, Dr. John Martignetti reported at the annual meeting of the Society of Gynecologic Oncology. “The CT scan did not pick up cancer that ctDNA [circulating tumor DNA] did.” Meanwhile, while essentially every patient had detectable ctDNA when tumor was present on CT, only about 60% had elevated cancer antigen 125 (CA-125) levels, said Dr. Martignetti of the Icahn School of Medicine at Mount Sinai, New York.
In a subgroup of 10 patients with known survival outcomes, five with no ctDNA after primary treatment had 22-33 months progression free survival, and all were alive at up to 5.4 years follow-up. Four of the five with ctDNA after primary treatment died within 29 months; the other patient progressed immediately and was alive with disease at 4.8 years.
“We demonstrated for the first time that personalized ctDNA biomarkers in gynecologic cancers can detect the presence of residual tumor earlier than currently used serum and imaging studies and are an independent predictor of survival. [They] dynamically predict treatment response and survival in gynecologic cancers. The measurement of ctDNA in blood – dubbed liquid biopsy – is “a powerful emerging technology capable of providing accurate assessment of both tumor behavior and disease burden,” Dr. Martignetti said.
“These mutations are only made in cancer cells,” so if they are in the blood, there must be cancer somewhere, he said.
The Sinai team identified specific mutations – in, for example, P53 tumor suppression, beta-catenin, or BRAF genes – in tumor cells from 36 of 44 women, using targeted sequencing for likely mutations in 28 samples and whole exome sequencing in eight. Blood samples were checked for ctDNA in 32 women by droplet digital PCR; ctDNA was detected in 30 (94%). The patients had high-grade endometrial carcinomas or high-grade serous carcinomas of the ovary, fallopian tube, or peritoneum.
For six women, ctDNA detected recurrence 1-11 months before CT. In once case, CA-125 was within normal limits a month before bowel resection for recurrence, and a PET scan 3 months before was negative. “Seven months before her surgery, we could detect ctDNA,” Dr. Martignetti said. For the rest of the women, sensitivity and specificity correlated with CA-125 and CT.
Mount Sinai has been working on ctDNA for almost a decade, and is among the pioneers in the field. Every gynecologic cancer patient there has tumor samples collected for sequencing and blood samples for ctDNA testing.
With ctDNA, “you can monitor the evolution of tumor growth, response to treatment, acquired resistance, and development of tumor heterogeneity.” If there’s no ctDNA, it seems likely “that patients can go home and say ‘whew.’ Lingering mutations” suggest the need for closer follow-up and perhaps additional chemotherapy.
The ultimate goal of liquid biopsy is to tailor cancer treatment to specific tumor mutations. Patients with fibroblast growth factor receptor (FGFR) gene mutations could get an FGFR inhibitor; ovarian tumors with lung cancer mutations might get lung cancer drugs. The approach is being tested by the National Institutes of Health through the NCI-MATCH trial.
It seems likely there’s also a role in screening. The Sinai team detected tumor DNA mutations in the uterine lavage fluid of a woman who presented with postmenopausal bleeding. A week later, pathology identified a microscopic stage 1, grade 1 endometrial cancer in situ. “That’s the future,” Dr. Martignetti said.
SAN DIEGO – Following chemotherapy and surgery for gynecologic cancer, circulating tumor DNA identified recurrence in six of 32 women a mean of 7 months before it was detected on CT scan, Dr. John Martignetti reported at the annual meeting of the Society of Gynecologic Oncology. “The CT scan did not pick up cancer that ctDNA [circulating tumor DNA] did.” Meanwhile, while essentially every patient had detectable ctDNA when tumor was present on CT, only about 60% had elevated cancer antigen 125 (CA-125) levels, said Dr. Martignetti of the Icahn School of Medicine at Mount Sinai, New York.
In a subgroup of 10 patients with known survival outcomes, five with no ctDNA after primary treatment had 22-33 months progression free survival, and all were alive at up to 5.4 years follow-up. Four of the five with ctDNA after primary treatment died within 29 months; the other patient progressed immediately and was alive with disease at 4.8 years.
“We demonstrated for the first time that personalized ctDNA biomarkers in gynecologic cancers can detect the presence of residual tumor earlier than currently used serum and imaging studies and are an independent predictor of survival. [They] dynamically predict treatment response and survival in gynecologic cancers. The measurement of ctDNA in blood – dubbed liquid biopsy – is “a powerful emerging technology capable of providing accurate assessment of both tumor behavior and disease burden,” Dr. Martignetti said.
“These mutations are only made in cancer cells,” so if they are in the blood, there must be cancer somewhere, he said.
The Sinai team identified specific mutations – in, for example, P53 tumor suppression, beta-catenin, or BRAF genes – in tumor cells from 36 of 44 women, using targeted sequencing for likely mutations in 28 samples and whole exome sequencing in eight. Blood samples were checked for ctDNA in 32 women by droplet digital PCR; ctDNA was detected in 30 (94%). The patients had high-grade endometrial carcinomas or high-grade serous carcinomas of the ovary, fallopian tube, or peritoneum.
For six women, ctDNA detected recurrence 1-11 months before CT. In once case, CA-125 was within normal limits a month before bowel resection for recurrence, and a PET scan 3 months before was negative. “Seven months before her surgery, we could detect ctDNA,” Dr. Martignetti said. For the rest of the women, sensitivity and specificity correlated with CA-125 and CT.
Mount Sinai has been working on ctDNA for almost a decade, and is among the pioneers in the field. Every gynecologic cancer patient there has tumor samples collected for sequencing and blood samples for ctDNA testing.
With ctDNA, “you can monitor the evolution of tumor growth, response to treatment, acquired resistance, and development of tumor heterogeneity.” If there’s no ctDNA, it seems likely “that patients can go home and say ‘whew.’ Lingering mutations” suggest the need for closer follow-up and perhaps additional chemotherapy.
The ultimate goal of liquid biopsy is to tailor cancer treatment to specific tumor mutations. Patients with fibroblast growth factor receptor (FGFR) gene mutations could get an FGFR inhibitor; ovarian tumors with lung cancer mutations might get lung cancer drugs. The approach is being tested by the National Institutes of Health through the NCI-MATCH trial.
It seems likely there’s also a role in screening. The Sinai team detected tumor DNA mutations in the uterine lavage fluid of a woman who presented with postmenopausal bleeding. A week later, pathology identified a microscopic stage 1, grade 1 endometrial cancer in situ. “That’s the future,” Dr. Martignetti said.
AT THE ANNUAL MEETING ON WOMEN’S CANCER
Key clinical point: If tumor DNA is in the blood, cancer is present.
Major finding: Following chemotherapy and surgery for gynecologic cancer, circulating tumor DNA identified recurrence in six of 32 patients a mean of 7 months before it was detected on CT scan.
Data source: Forty-four women with gynecologic cancer.
Disclosures: The work was funded by philanthropies. RainDance Technologies and Swift Biosciences provided technical support and study reagents. Dr. Martignetti had no relevant disclosures.
How physicians can reverse the opioid crisis
In about 2002, Dr. Gary Franklin realized the state of Washington might have a problem.
A big problem.
A state resident who’d suffered a back sprain and filed a workers’ compensation claim died 2 years later – not from heart disease or cancer or stroke, but from an unintentional prescription opioid overdose, recalled Dr. Franklin, medical director of the Washington State Department of Labor and Industries.
“I had never seen anything so sad,” he said.
The case prompted the neurologist and his colleagues to review Washington state workers’ compensation claims. What they uncovered was a local trend that would explode into a national scourge: a marked increase in opioid poisonings among Washington state residents with everyday aches and pains who, in the past, would never have been prescribed opioids.
The gateway drug turned out to be oxycodone (OxyContin), which was heavily marketed at the time as a safe choice for pain relief with little abuse potential. Purdue Pharma has since paid a $600 million federal fine for deceptive marketing.
“This is the worst man-made epidemic in modern medical history,” said Dr. Franklin, also a research professor at the University of Washington, Seattle. “It was made by modern medicine, and it’s up to modern medicine to turn it around.”
For the United States to recover from the opioid crisis, Dr. Franklin said, the medical community must reduce oral opioid prescriptions for noncancer pain. Others interviewed for this story said doctors also have to overcome their aversion to in-office addiction treatment, and find new options for everyday chronic pain.
The first step is “to forget everything you were told in 1999,” said Dr. Franklin. That includes the notions that addiction is rare, opioids are indicated for noncancer chronic pain, and doses should be increased if patients become tolerant.
Those messages led to overprescribing, which in turn “led to an oversupply problem that’s feeding misuse and diversion. It’s only recently that it has become a heroin problem; the vast majority of heroin users these days start on prescription opioids,” he said.
The Washington workers’ comp claims data triggered “a complete rethinking of our approach to chronic pain and a shift to other treatment strategies,” said Dr. David Tauben, chief of pain medicine at the University of Washington, Seattle.
In 2007, Washington became one of the first states to issue opioid treatment guidelines, which are updated regularly. Among other steps, prescribers were urged to limit doses and durations.
Since then, the state has seen a nearly 40% reduction in prescription opioid poisonings. “We also found that with dose reductions” for back pain, headaches, and similar noncancer issues, “pain subsides, function improves, and patient satisfaction” goes up, said Dr. Tauben, who was involved in creating the guidelines.
Clamping down, pushing back
The Centers for Disease Control and Prevention in March released similar guidelines, including a suggested 3-day limit for acute pain prescriptions and a cap of 90 morphine milligram equivalents per day for chronic noncancer pain – the amount in a single 60-mg oxycodone tablet.
Meanwhile, Food and Drug Administration officials are planning a regulatory overhaul to address opioid approval, labeling, and prescribing concerns. In many places, doctors are also facing new opioid training requirements.
The Washington state experience suggests that such efforts are likely to help reverse the opioid crisis.
It’s not about getting rid of the drugs, explained Dr. Gail D’Onofrio, chair of emergency medicine at Yale University in New Haven, Conn.
“Opioids are really good for certain things,” especially cancer pain and, for a few days, acute pain. But “we’ve kind of lost our way,” Dr. D’Onofrio said. “We don’t need to give people 3 months of narcotics for a knee replacement” or 3 weeks of narcotics for a wisdom tooth extraction.
“We are all guilty” of overprescribing, and “just like everywhere else, we’ve seen the problems; every year, it’s getting worse,” she added. In response, “we are changing how we use opioids, adapting the guidelines from the CDC and other groups,” and tailoring them to different services.
At the Yale emergency department, oral opioid prescriptions are now generally limited to 3 days, except for renal colic patients, who might get a few days more. “We do not fill opioid scripts and don’t reorder them for patients.” Instead, “we talk to the prescriber and tell them what’s going on,” Dr. D’Onofrio explained.
Yale’s not alone in cutting back. After years of growth, U.S. oral opioid sales appear to be declining. In fact, in some quarters, there’s concern the clampdown will go too far.
The CDC received more than 4,300 comments about the draft version of its guidelines. Some patients were worried about losing access to drugs that have helped them. And, while supportive of the goals, some professional groups questioned the evidence behind the proposals and worry about undertreatment of pain, among other issues.
“The problem with a lot of the guidelines is that they’re all around limiting prescribing. They don’t really tell doctors what to do instead,” said Dr. Peter Friedmann, an addiction treatment specialist in Springfield, Mass., and chief research officer for Baystate Health.
An alternative for chronic pain
For noncancer chronic pain, recent evidence supports multimodal therapy. Opioids might bring temporary relief, but “throwing drugs at people isn’t going to solve the problem,” said Dr. Tauben, the University of Washington pain expert.
“Multimodal therapy” means focusing more on the burden of pain instead of its intensity, with team-based care. Reducing the burden – anxiety, sleeplessness, reduced mobility, and other problems – seems to reduce the significance and intensity of pain to the point where it can be managed, if needed, with nonsteroidal anti-inflammatory drugs (NSAIDs), trigger-point injections, and other nonopioid options.
Depending on the patient’s needs, primary care physicians might find themselves coordinating services from psychologists, physical therapists, social workers, or others.
For the approach to work, the impact of pain has to be accurately gauged, along with underlying psychological or social issues; to save time, the University of Washington has patients complete an online survey prior to their office visit.
There are national efforts underway to support the approach, and a growing recognition that “by doing it right, you save downstream costs. Primary care must get involved; that’s where chronic pain presents,” Dr. Tauben said.
Batting cleanup
There’s a role for primary care when patients are hooked on opioids, too. Requests for early refills and higher doses are a clue.
“Given the stigma, a lot of doctors don’t want to deal with addiction, but we have to deal with it. We need to move addiction treatment into the mainstream of what we do in medicine,” Dr. Friedmann said. “These patients are no more or no less challenging than any other patients we deal with; the only way doctors are going to find that out is by starting to manage some of them.”
He estimates that about 60% of his patients do well on buprenorphine, a sublingual, partial opioid agonist that blocks the effects of full agonists and dulls withdrawal symptoms. Incorporating it into practice “is not something you need to figure out yourself,” Dr. Friedmann noted. There are training programs and people who can help.
There simply aren’t enough methadone clinics to handle the current situation, especially in suburbs and rural areas where drug dealers have found a new market for heroin. Another option, abstinence programs, “have contributed to the problem of overdose;” people lose their tolerance, reuse, and die, he said.
Buprenorphine treatment might soon get easier. The FDA is expected to make an approval decision soon on probuphine, a matchstick-size subdermal implant that delivers buprenorphine continuously for 6 months.
Dr. Friedmann disclosed relationships with Alkermes, Inavir, and Orexo. The other doctors had no relevant disclosures.
In about 2002, Dr. Gary Franklin realized the state of Washington might have a problem.
A big problem.
A state resident who’d suffered a back sprain and filed a workers’ compensation claim died 2 years later – not from heart disease or cancer or stroke, but from an unintentional prescription opioid overdose, recalled Dr. Franklin, medical director of the Washington State Department of Labor and Industries.
“I had never seen anything so sad,” he said.
The case prompted the neurologist and his colleagues to review Washington state workers’ compensation claims. What they uncovered was a local trend that would explode into a national scourge: a marked increase in opioid poisonings among Washington state residents with everyday aches and pains who, in the past, would never have been prescribed opioids.
The gateway drug turned out to be oxycodone (OxyContin), which was heavily marketed at the time as a safe choice for pain relief with little abuse potential. Purdue Pharma has since paid a $600 million federal fine for deceptive marketing.
“This is the worst man-made epidemic in modern medical history,” said Dr. Franklin, also a research professor at the University of Washington, Seattle. “It was made by modern medicine, and it’s up to modern medicine to turn it around.”
For the United States to recover from the opioid crisis, Dr. Franklin said, the medical community must reduce oral opioid prescriptions for noncancer pain. Others interviewed for this story said doctors also have to overcome their aversion to in-office addiction treatment, and find new options for everyday chronic pain.
The first step is “to forget everything you were told in 1999,” said Dr. Franklin. That includes the notions that addiction is rare, opioids are indicated for noncancer chronic pain, and doses should be increased if patients become tolerant.
Those messages led to overprescribing, which in turn “led to an oversupply problem that’s feeding misuse and diversion. It’s only recently that it has become a heroin problem; the vast majority of heroin users these days start on prescription opioids,” he said.
The Washington workers’ comp claims data triggered “a complete rethinking of our approach to chronic pain and a shift to other treatment strategies,” said Dr. David Tauben, chief of pain medicine at the University of Washington, Seattle.
In 2007, Washington became one of the first states to issue opioid treatment guidelines, which are updated regularly. Among other steps, prescribers were urged to limit doses and durations.
Since then, the state has seen a nearly 40% reduction in prescription opioid poisonings. “We also found that with dose reductions” for back pain, headaches, and similar noncancer issues, “pain subsides, function improves, and patient satisfaction” goes up, said Dr. Tauben, who was involved in creating the guidelines.
Clamping down, pushing back
The Centers for Disease Control and Prevention in March released similar guidelines, including a suggested 3-day limit for acute pain prescriptions and a cap of 90 morphine milligram equivalents per day for chronic noncancer pain – the amount in a single 60-mg oxycodone tablet.
Meanwhile, Food and Drug Administration officials are planning a regulatory overhaul to address opioid approval, labeling, and prescribing concerns. In many places, doctors are also facing new opioid training requirements.
The Washington state experience suggests that such efforts are likely to help reverse the opioid crisis.
It’s not about getting rid of the drugs, explained Dr. Gail D’Onofrio, chair of emergency medicine at Yale University in New Haven, Conn.
“Opioids are really good for certain things,” especially cancer pain and, for a few days, acute pain. But “we’ve kind of lost our way,” Dr. D’Onofrio said. “We don’t need to give people 3 months of narcotics for a knee replacement” or 3 weeks of narcotics for a wisdom tooth extraction.
“We are all guilty” of overprescribing, and “just like everywhere else, we’ve seen the problems; every year, it’s getting worse,” she added. In response, “we are changing how we use opioids, adapting the guidelines from the CDC and other groups,” and tailoring them to different services.
At the Yale emergency department, oral opioid prescriptions are now generally limited to 3 days, except for renal colic patients, who might get a few days more. “We do not fill opioid scripts and don’t reorder them for patients.” Instead, “we talk to the prescriber and tell them what’s going on,” Dr. D’Onofrio explained.
Yale’s not alone in cutting back. After years of growth, U.S. oral opioid sales appear to be declining. In fact, in some quarters, there’s concern the clampdown will go too far.
The CDC received more than 4,300 comments about the draft version of its guidelines. Some patients were worried about losing access to drugs that have helped them. And, while supportive of the goals, some professional groups questioned the evidence behind the proposals and worry about undertreatment of pain, among other issues.
“The problem with a lot of the guidelines is that they’re all around limiting prescribing. They don’t really tell doctors what to do instead,” said Dr. Peter Friedmann, an addiction treatment specialist in Springfield, Mass., and chief research officer for Baystate Health.
An alternative for chronic pain
For noncancer chronic pain, recent evidence supports multimodal therapy. Opioids might bring temporary relief, but “throwing drugs at people isn’t going to solve the problem,” said Dr. Tauben, the University of Washington pain expert.
“Multimodal therapy” means focusing more on the burden of pain instead of its intensity, with team-based care. Reducing the burden – anxiety, sleeplessness, reduced mobility, and other problems – seems to reduce the significance and intensity of pain to the point where it can be managed, if needed, with nonsteroidal anti-inflammatory drugs (NSAIDs), trigger-point injections, and other nonopioid options.
Depending on the patient’s needs, primary care physicians might find themselves coordinating services from psychologists, physical therapists, social workers, or others.
For the approach to work, the impact of pain has to be accurately gauged, along with underlying psychological or social issues; to save time, the University of Washington has patients complete an online survey prior to their office visit.
There are national efforts underway to support the approach, and a growing recognition that “by doing it right, you save downstream costs. Primary care must get involved; that’s where chronic pain presents,” Dr. Tauben said.
Batting cleanup
There’s a role for primary care when patients are hooked on opioids, too. Requests for early refills and higher doses are a clue.
“Given the stigma, a lot of doctors don’t want to deal with addiction, but we have to deal with it. We need to move addiction treatment into the mainstream of what we do in medicine,” Dr. Friedmann said. “These patients are no more or no less challenging than any other patients we deal with; the only way doctors are going to find that out is by starting to manage some of them.”
He estimates that about 60% of his patients do well on buprenorphine, a sublingual, partial opioid agonist that blocks the effects of full agonists and dulls withdrawal symptoms. Incorporating it into practice “is not something you need to figure out yourself,” Dr. Friedmann noted. There are training programs and people who can help.
There simply aren’t enough methadone clinics to handle the current situation, especially in suburbs and rural areas where drug dealers have found a new market for heroin. Another option, abstinence programs, “have contributed to the problem of overdose;” people lose their tolerance, reuse, and die, he said.
Buprenorphine treatment might soon get easier. The FDA is expected to make an approval decision soon on probuphine, a matchstick-size subdermal implant that delivers buprenorphine continuously for 6 months.
Dr. Friedmann disclosed relationships with Alkermes, Inavir, and Orexo. The other doctors had no relevant disclosures.
In about 2002, Dr. Gary Franklin realized the state of Washington might have a problem.
A big problem.
A state resident who’d suffered a back sprain and filed a workers’ compensation claim died 2 years later – not from heart disease or cancer or stroke, but from an unintentional prescription opioid overdose, recalled Dr. Franklin, medical director of the Washington State Department of Labor and Industries.
“I had never seen anything so sad,” he said.
The case prompted the neurologist and his colleagues to review Washington state workers’ compensation claims. What they uncovered was a local trend that would explode into a national scourge: a marked increase in opioid poisonings among Washington state residents with everyday aches and pains who, in the past, would never have been prescribed opioids.
The gateway drug turned out to be oxycodone (OxyContin), which was heavily marketed at the time as a safe choice for pain relief with little abuse potential. Purdue Pharma has since paid a $600 million federal fine for deceptive marketing.
“This is the worst man-made epidemic in modern medical history,” said Dr. Franklin, also a research professor at the University of Washington, Seattle. “It was made by modern medicine, and it’s up to modern medicine to turn it around.”
For the United States to recover from the opioid crisis, Dr. Franklin said, the medical community must reduce oral opioid prescriptions for noncancer pain. Others interviewed for this story said doctors also have to overcome their aversion to in-office addiction treatment, and find new options for everyday chronic pain.
The first step is “to forget everything you were told in 1999,” said Dr. Franklin. That includes the notions that addiction is rare, opioids are indicated for noncancer chronic pain, and doses should be increased if patients become tolerant.
Those messages led to overprescribing, which in turn “led to an oversupply problem that’s feeding misuse and diversion. It’s only recently that it has become a heroin problem; the vast majority of heroin users these days start on prescription opioids,” he said.
The Washington workers’ comp claims data triggered “a complete rethinking of our approach to chronic pain and a shift to other treatment strategies,” said Dr. David Tauben, chief of pain medicine at the University of Washington, Seattle.
In 2007, Washington became one of the first states to issue opioid treatment guidelines, which are updated regularly. Among other steps, prescribers were urged to limit doses and durations.
Since then, the state has seen a nearly 40% reduction in prescription opioid poisonings. “We also found that with dose reductions” for back pain, headaches, and similar noncancer issues, “pain subsides, function improves, and patient satisfaction” goes up, said Dr. Tauben, who was involved in creating the guidelines.
Clamping down, pushing back
The Centers for Disease Control and Prevention in March released similar guidelines, including a suggested 3-day limit for acute pain prescriptions and a cap of 90 morphine milligram equivalents per day for chronic noncancer pain – the amount in a single 60-mg oxycodone tablet.
Meanwhile, Food and Drug Administration officials are planning a regulatory overhaul to address opioid approval, labeling, and prescribing concerns. In many places, doctors are also facing new opioid training requirements.
The Washington state experience suggests that such efforts are likely to help reverse the opioid crisis.
It’s not about getting rid of the drugs, explained Dr. Gail D’Onofrio, chair of emergency medicine at Yale University in New Haven, Conn.
“Opioids are really good for certain things,” especially cancer pain and, for a few days, acute pain. But “we’ve kind of lost our way,” Dr. D’Onofrio said. “We don’t need to give people 3 months of narcotics for a knee replacement” or 3 weeks of narcotics for a wisdom tooth extraction.
“We are all guilty” of overprescribing, and “just like everywhere else, we’ve seen the problems; every year, it’s getting worse,” she added. In response, “we are changing how we use opioids, adapting the guidelines from the CDC and other groups,” and tailoring them to different services.
At the Yale emergency department, oral opioid prescriptions are now generally limited to 3 days, except for renal colic patients, who might get a few days more. “We do not fill opioid scripts and don’t reorder them for patients.” Instead, “we talk to the prescriber and tell them what’s going on,” Dr. D’Onofrio explained.
Yale’s not alone in cutting back. After years of growth, U.S. oral opioid sales appear to be declining. In fact, in some quarters, there’s concern the clampdown will go too far.
The CDC received more than 4,300 comments about the draft version of its guidelines. Some patients were worried about losing access to drugs that have helped them. And, while supportive of the goals, some professional groups questioned the evidence behind the proposals and worry about undertreatment of pain, among other issues.
“The problem with a lot of the guidelines is that they’re all around limiting prescribing. They don’t really tell doctors what to do instead,” said Dr. Peter Friedmann, an addiction treatment specialist in Springfield, Mass., and chief research officer for Baystate Health.
An alternative for chronic pain
For noncancer chronic pain, recent evidence supports multimodal therapy. Opioids might bring temporary relief, but “throwing drugs at people isn’t going to solve the problem,” said Dr. Tauben, the University of Washington pain expert.
“Multimodal therapy” means focusing more on the burden of pain instead of its intensity, with team-based care. Reducing the burden – anxiety, sleeplessness, reduced mobility, and other problems – seems to reduce the significance and intensity of pain to the point where it can be managed, if needed, with nonsteroidal anti-inflammatory drugs (NSAIDs), trigger-point injections, and other nonopioid options.
Depending on the patient’s needs, primary care physicians might find themselves coordinating services from psychologists, physical therapists, social workers, or others.
For the approach to work, the impact of pain has to be accurately gauged, along with underlying psychological or social issues; to save time, the University of Washington has patients complete an online survey prior to their office visit.
There are national efforts underway to support the approach, and a growing recognition that “by doing it right, you save downstream costs. Primary care must get involved; that’s where chronic pain presents,” Dr. Tauben said.
Batting cleanup
There’s a role for primary care when patients are hooked on opioids, too. Requests for early refills and higher doses are a clue.
“Given the stigma, a lot of doctors don’t want to deal with addiction, but we have to deal with it. We need to move addiction treatment into the mainstream of what we do in medicine,” Dr. Friedmann said. “These patients are no more or no less challenging than any other patients we deal with; the only way doctors are going to find that out is by starting to manage some of them.”
He estimates that about 60% of his patients do well on buprenorphine, a sublingual, partial opioid agonist that blocks the effects of full agonists and dulls withdrawal symptoms. Incorporating it into practice “is not something you need to figure out yourself,” Dr. Friedmann noted. There are training programs and people who can help.
There simply aren’t enough methadone clinics to handle the current situation, especially in suburbs and rural areas where drug dealers have found a new market for heroin. Another option, abstinence programs, “have contributed to the problem of overdose;” people lose their tolerance, reuse, and die, he said.
Buprenorphine treatment might soon get easier. The FDA is expected to make an approval decision soon on probuphine, a matchstick-size subdermal implant that delivers buprenorphine continuously for 6 months.
Dr. Friedmann disclosed relationships with Alkermes, Inavir, and Orexo. The other doctors had no relevant disclosures.
High false positives found for Medtronic’s implantable AF detectors
LOS ANGELES – Medtronic’s Reveal LINQ implantable loop recorders misidentified 84% of rhythm anomalies as atrial fibrillation in 52 stroke patients at Emory University in Atlanta, according to a presentation at the International Stroke Conference.
Two electrophysiologists reviewed a random sample of 166 rhythm strips from those patients that were identified by Reveal as atrial fibrillation (AF) over a 2-month period; 140 (84%) were false positives. Eighty (57%) of the false positives were premature atrial complexes, 31 (22%) were due to T wave over-sensing, 14 (10%) to noise, 7 (5%) to premature ventricular complexes, 4 (2.9%) to under-sensing, and 4 (2.9%) to sinus arrhythmias.
There wasn’t a mix-and-match of true and false positives in the same patient; false and true positives were consistent in patients over the study period.
The take-home message from the study is that the high sensitivity of Medtronic’s implantable loop recorders means that they are good at detecting possible AF, but their findings must be reviewed and confirmed before being acted upon.
“There are high rates of false positives, but the results can be easily adjudicated by electrophysiologists as evidenced by our observer agreement,” which was 100%. “These strips need to be adjudicated by somebody, and not taken at face value,” said investigator Dr. Spencer Maddox, an Emory resident.
The devices look mainly at RR intervals and the presence or absence of P waves. Runs of 2 minutes are required for AF. One of the issues in the study was that T waves were identified as QRS complexes, which changed the RR interval and trigged the device to report AF, he said.
Medtronic could reduce the false positive rate by, for instance, extending the run required for AF, but it would be a bad idea. “The goal here is to not miss atrial fibrillation,” Dr. Maddox said. “There are false positives, but as long as you go back and reread, I think that’s fine. I wouldn’t mess with the sensitivity of the device.”
The company said the same thing when asked for comment on the study.
“The AF detection algorithm ... is tuned to favor sensitivity because manual review can subsequently rule out any false positives. This is one reason it is important to have trained cardiologists or electrophysiologists involved in reviewing reports of irregular heart rhythms to determine a diagnosis of AF,” said Medtronic spokesman Ryan Mathre, who also noted that company data suggest a lower false positive rate (Cerebrovasc Dis. 2015;40:175-81).
Even so, confirmation doesn’t always happen, “and that’s the scary part. In practice almost all the time,” the report comes in “and it’s acted on,” said Dr. Robert Hart, a neurology professor at McMaster University in Hamilton, Ont., and comoderator of the study presentation.
The Emory patients were all recovering from ischemic strokes or TIAs. They were about 70 years old on average, about 60% were men, and almost all were white. A total of 38 had implantable loop recorders for cryptogenic strokes; the devices detected true AF in 4 (11%) after a mean of 92 days. Early Holter monitoring missed it.
Emory generally prescribes anticoagulants if AF is confirmed, but, as several audience members noted, the burden of AF that requires anticoagulation is unclear. “It’s an area with a lot of thought now, but no good answers,” Dr. Maddox said at the conference, sponsored by the American Heart Association.
The investigators had no disclosures, and there was no outside funding for the work.
LOS ANGELES – Medtronic’s Reveal LINQ implantable loop recorders misidentified 84% of rhythm anomalies as atrial fibrillation in 52 stroke patients at Emory University in Atlanta, according to a presentation at the International Stroke Conference.
Two electrophysiologists reviewed a random sample of 166 rhythm strips from those patients that were identified by Reveal as atrial fibrillation (AF) over a 2-month period; 140 (84%) were false positives. Eighty (57%) of the false positives were premature atrial complexes, 31 (22%) were due to T wave over-sensing, 14 (10%) to noise, 7 (5%) to premature ventricular complexes, 4 (2.9%) to under-sensing, and 4 (2.9%) to sinus arrhythmias.
There wasn’t a mix-and-match of true and false positives in the same patient; false and true positives were consistent in patients over the study period.
The take-home message from the study is that the high sensitivity of Medtronic’s implantable loop recorders means that they are good at detecting possible AF, but their findings must be reviewed and confirmed before being acted upon.
“There are high rates of false positives, but the results can be easily adjudicated by electrophysiologists as evidenced by our observer agreement,” which was 100%. “These strips need to be adjudicated by somebody, and not taken at face value,” said investigator Dr. Spencer Maddox, an Emory resident.
The devices look mainly at RR intervals and the presence or absence of P waves. Runs of 2 minutes are required for AF. One of the issues in the study was that T waves were identified as QRS complexes, which changed the RR interval and trigged the device to report AF, he said.
Medtronic could reduce the false positive rate by, for instance, extending the run required for AF, but it would be a bad idea. “The goal here is to not miss atrial fibrillation,” Dr. Maddox said. “There are false positives, but as long as you go back and reread, I think that’s fine. I wouldn’t mess with the sensitivity of the device.”
The company said the same thing when asked for comment on the study.
“The AF detection algorithm ... is tuned to favor sensitivity because manual review can subsequently rule out any false positives. This is one reason it is important to have trained cardiologists or electrophysiologists involved in reviewing reports of irregular heart rhythms to determine a diagnosis of AF,” said Medtronic spokesman Ryan Mathre, who also noted that company data suggest a lower false positive rate (Cerebrovasc Dis. 2015;40:175-81).
Even so, confirmation doesn’t always happen, “and that’s the scary part. In practice almost all the time,” the report comes in “and it’s acted on,” said Dr. Robert Hart, a neurology professor at McMaster University in Hamilton, Ont., and comoderator of the study presentation.
The Emory patients were all recovering from ischemic strokes or TIAs. They were about 70 years old on average, about 60% were men, and almost all were white. A total of 38 had implantable loop recorders for cryptogenic strokes; the devices detected true AF in 4 (11%) after a mean of 92 days. Early Holter monitoring missed it.
Emory generally prescribes anticoagulants if AF is confirmed, but, as several audience members noted, the burden of AF that requires anticoagulation is unclear. “It’s an area with a lot of thought now, but no good answers,” Dr. Maddox said at the conference, sponsored by the American Heart Association.
The investigators had no disclosures, and there was no outside funding for the work.
LOS ANGELES – Medtronic’s Reveal LINQ implantable loop recorders misidentified 84% of rhythm anomalies as atrial fibrillation in 52 stroke patients at Emory University in Atlanta, according to a presentation at the International Stroke Conference.
Two electrophysiologists reviewed a random sample of 166 rhythm strips from those patients that were identified by Reveal as atrial fibrillation (AF) over a 2-month period; 140 (84%) were false positives. Eighty (57%) of the false positives were premature atrial complexes, 31 (22%) were due to T wave over-sensing, 14 (10%) to noise, 7 (5%) to premature ventricular complexes, 4 (2.9%) to under-sensing, and 4 (2.9%) to sinus arrhythmias.
There wasn’t a mix-and-match of true and false positives in the same patient; false and true positives were consistent in patients over the study period.
The take-home message from the study is that the high sensitivity of Medtronic’s implantable loop recorders means that they are good at detecting possible AF, but their findings must be reviewed and confirmed before being acted upon.
“There are high rates of false positives, but the results can be easily adjudicated by electrophysiologists as evidenced by our observer agreement,” which was 100%. “These strips need to be adjudicated by somebody, and not taken at face value,” said investigator Dr. Spencer Maddox, an Emory resident.
The devices look mainly at RR intervals and the presence or absence of P waves. Runs of 2 minutes are required for AF. One of the issues in the study was that T waves were identified as QRS complexes, which changed the RR interval and trigged the device to report AF, he said.
Medtronic could reduce the false positive rate by, for instance, extending the run required for AF, but it would be a bad idea. “The goal here is to not miss atrial fibrillation,” Dr. Maddox said. “There are false positives, but as long as you go back and reread, I think that’s fine. I wouldn’t mess with the sensitivity of the device.”
The company said the same thing when asked for comment on the study.
“The AF detection algorithm ... is tuned to favor sensitivity because manual review can subsequently rule out any false positives. This is one reason it is important to have trained cardiologists or electrophysiologists involved in reviewing reports of irregular heart rhythms to determine a diagnosis of AF,” said Medtronic spokesman Ryan Mathre, who also noted that company data suggest a lower false positive rate (Cerebrovasc Dis. 2015;40:175-81).
Even so, confirmation doesn’t always happen, “and that’s the scary part. In practice almost all the time,” the report comes in “and it’s acted on,” said Dr. Robert Hart, a neurology professor at McMaster University in Hamilton, Ont., and comoderator of the study presentation.
The Emory patients were all recovering from ischemic strokes or TIAs. They were about 70 years old on average, about 60% were men, and almost all were white. A total of 38 had implantable loop recorders for cryptogenic strokes; the devices detected true AF in 4 (11%) after a mean of 92 days. Early Holter monitoring missed it.
Emory generally prescribes anticoagulants if AF is confirmed, but, as several audience members noted, the burden of AF that requires anticoagulation is unclear. “It’s an area with a lot of thought now, but no good answers,” Dr. Maddox said at the conference, sponsored by the American Heart Association.
The investigators had no disclosures, and there was no outside funding for the work.
AT The INTERNATIONAL STROKE CONFERENCE
Key clinical point: The high sensitivity of Medtronic’s implantable loop recorders means that they’re good at detecting possible AF, but their findings must be reviewed and confirmed before being acted upon.
Major finding: Two electrophysiologists reviewed a random sample of 166 rhythm strips identified by Reveal as atrial fibrillation; 140 (84%) were false positives.
Data source: Fifty-two ischemic stroke and TIA patients.
Disclosures: The investigators had no disclosures. There was no outside funding for the work.
Lower the CT to check the heart for embolic sources in acute stroke
LOS ANGELES – Enlarge the field of CT angiography to include the heart in acute ischemic stroke patients; you’ll quickly identify sources of cardiogenic emboli and other problems that will otherwise be missed, according to investigators from the National University Hospital, Singapore.
It adds only a few seconds to the scan, with no extra contrast or meaningful increase in radiation. There’s no need to gate the heart with beta-blockers.
Among 20 acute ischemic stroke patients presenting within 4.5 hours of symptom onset, Dr. Leonard Yeo and his coinvestigators found one with a localized dissection in the ascending aorta, another with a ventricular thrombus, and a third with an atrial appendage blood clot. Both thrombus cases were confirmed by transesophageal echocardiography and started on anticoagulation the next day. The 2-phase, 64-slice nongated cardiac CT angiographies (CTA) were done in the same sitting as the brain CTA.
“Scans with 1-mm thick slices are best for screening for thrombus and structural abnormalities that cause embolism. Remarkably, [even without gating], the detail is excellent. There’s very little downside [to this, and] it maximizes your return on scans that are already a part of most acute stroke protocols,” said Dr. Yeo, a neurologist at the hospital.
“Since most of our patients get a CTA during acute stroke, it made sense to check the heart for embolic sources.” There isn’t any time to give a beta-blocker, so “these were nongated” scans, Dr. Yeo said during his presentation at the International Stroke Conference, sponsored by the American Heart Association.
If it’s confirmed that nongated heart CTAs provide useful information, “we will probably all be doing this in the future. Everybody does CTs for the head in acute stroke, so all you do is go down a little lower” without any more contrast. “Within an hour of somebody presenting, you know what they have,” said Dr. Robert Hart, a neurology professor at McMaster University in Hamilton, Ont., and co-moderator of Dr. Yeo’s presentation.
In most places, acute ischemic stroke patients only get an ECG. Transesophageal echocardiography (TEE) is also good for checking the heart, but it usually comes later. It “excels at detecting abnormalities with medium embolic risk,” such as patent foramen ovale and septal aneurysm. “However, for these medium-risk cardiac sources of embolism, the optimal choice of therapy is not clear. Unlike high-risk sources which require anticoagulation, TEE does not provide therapeutic gains in terms of clinical decision making,” Dr. Yeo said.
Nongated cardiac CTAs during acute stroke, he added, also check chamber, valve, pericardial, and great vessel morphology, as well as abnormal chambers-vessel communications and “left ventricular aneurysms that can rupture with [tissue plasminogen activator], with catastrophic consequences.”
The mean age in the study was 64 years old, and about 60% of the subjects were men. None of the patients were dead at 3 months, and by then eight (40%) had modified Rankin Scale scores of 0-1. Patients were excluded if they had contraindications to IV contrast, or were unable to provide informed consent. CTA images were read by the treating neurologist and radiologist.
The work was funded by the Singapore Ministry of Health’s National Medical Research Council. The investigators have no relevant disclosures.
LOS ANGELES – Enlarge the field of CT angiography to include the heart in acute ischemic stroke patients; you’ll quickly identify sources of cardiogenic emboli and other problems that will otherwise be missed, according to investigators from the National University Hospital, Singapore.
It adds only a few seconds to the scan, with no extra contrast or meaningful increase in radiation. There’s no need to gate the heart with beta-blockers.
Among 20 acute ischemic stroke patients presenting within 4.5 hours of symptom onset, Dr. Leonard Yeo and his coinvestigators found one with a localized dissection in the ascending aorta, another with a ventricular thrombus, and a third with an atrial appendage blood clot. Both thrombus cases were confirmed by transesophageal echocardiography and started on anticoagulation the next day. The 2-phase, 64-slice nongated cardiac CT angiographies (CTA) were done in the same sitting as the brain CTA.
“Scans with 1-mm thick slices are best for screening for thrombus and structural abnormalities that cause embolism. Remarkably, [even without gating], the detail is excellent. There’s very little downside [to this, and] it maximizes your return on scans that are already a part of most acute stroke protocols,” said Dr. Yeo, a neurologist at the hospital.
“Since most of our patients get a CTA during acute stroke, it made sense to check the heart for embolic sources.” There isn’t any time to give a beta-blocker, so “these were nongated” scans, Dr. Yeo said during his presentation at the International Stroke Conference, sponsored by the American Heart Association.
If it’s confirmed that nongated heart CTAs provide useful information, “we will probably all be doing this in the future. Everybody does CTs for the head in acute stroke, so all you do is go down a little lower” without any more contrast. “Within an hour of somebody presenting, you know what they have,” said Dr. Robert Hart, a neurology professor at McMaster University in Hamilton, Ont., and co-moderator of Dr. Yeo’s presentation.
In most places, acute ischemic stroke patients only get an ECG. Transesophageal echocardiography (TEE) is also good for checking the heart, but it usually comes later. It “excels at detecting abnormalities with medium embolic risk,” such as patent foramen ovale and septal aneurysm. “However, for these medium-risk cardiac sources of embolism, the optimal choice of therapy is not clear. Unlike high-risk sources which require anticoagulation, TEE does not provide therapeutic gains in terms of clinical decision making,” Dr. Yeo said.
Nongated cardiac CTAs during acute stroke, he added, also check chamber, valve, pericardial, and great vessel morphology, as well as abnormal chambers-vessel communications and “left ventricular aneurysms that can rupture with [tissue plasminogen activator], with catastrophic consequences.”
The mean age in the study was 64 years old, and about 60% of the subjects were men. None of the patients were dead at 3 months, and by then eight (40%) had modified Rankin Scale scores of 0-1. Patients were excluded if they had contraindications to IV contrast, or were unable to provide informed consent. CTA images were read by the treating neurologist and radiologist.
The work was funded by the Singapore Ministry of Health’s National Medical Research Council. The investigators have no relevant disclosures.
LOS ANGELES – Enlarge the field of CT angiography to include the heart in acute ischemic stroke patients; you’ll quickly identify sources of cardiogenic emboli and other problems that will otherwise be missed, according to investigators from the National University Hospital, Singapore.
It adds only a few seconds to the scan, with no extra contrast or meaningful increase in radiation. There’s no need to gate the heart with beta-blockers.
Among 20 acute ischemic stroke patients presenting within 4.5 hours of symptom onset, Dr. Leonard Yeo and his coinvestigators found one with a localized dissection in the ascending aorta, another with a ventricular thrombus, and a third with an atrial appendage blood clot. Both thrombus cases were confirmed by transesophageal echocardiography and started on anticoagulation the next day. The 2-phase, 64-slice nongated cardiac CT angiographies (CTA) were done in the same sitting as the brain CTA.
“Scans with 1-mm thick slices are best for screening for thrombus and structural abnormalities that cause embolism. Remarkably, [even without gating], the detail is excellent. There’s very little downside [to this, and] it maximizes your return on scans that are already a part of most acute stroke protocols,” said Dr. Yeo, a neurologist at the hospital.
“Since most of our patients get a CTA during acute stroke, it made sense to check the heart for embolic sources.” There isn’t any time to give a beta-blocker, so “these were nongated” scans, Dr. Yeo said during his presentation at the International Stroke Conference, sponsored by the American Heart Association.
If it’s confirmed that nongated heart CTAs provide useful information, “we will probably all be doing this in the future. Everybody does CTs for the head in acute stroke, so all you do is go down a little lower” without any more contrast. “Within an hour of somebody presenting, you know what they have,” said Dr. Robert Hart, a neurology professor at McMaster University in Hamilton, Ont., and co-moderator of Dr. Yeo’s presentation.
In most places, acute ischemic stroke patients only get an ECG. Transesophageal echocardiography (TEE) is also good for checking the heart, but it usually comes later. It “excels at detecting abnormalities with medium embolic risk,” such as patent foramen ovale and septal aneurysm. “However, for these medium-risk cardiac sources of embolism, the optimal choice of therapy is not clear. Unlike high-risk sources which require anticoagulation, TEE does not provide therapeutic gains in terms of clinical decision making,” Dr. Yeo said.
Nongated cardiac CTAs during acute stroke, he added, also check chamber, valve, pericardial, and great vessel morphology, as well as abnormal chambers-vessel communications and “left ventricular aneurysms that can rupture with [tissue plasminogen activator], with catastrophic consequences.”
The mean age in the study was 64 years old, and about 60% of the subjects were men. None of the patients were dead at 3 months, and by then eight (40%) had modified Rankin Scale scores of 0-1. Patients were excluded if they had contraindications to IV contrast, or were unable to provide informed consent. CTA images were read by the treating neurologist and radiologist.
The work was funded by the Singapore Ministry of Health’s National Medical Research Council. The investigators have no relevant disclosures.
AT THE INTERNATIONAL STROKE CONFERENCE
Key clinical point: Nongated heart CTAs may provide useful information in acute ischemic stroke.
Major finding: Among 20 acute ischemic stroke patients presenting within 4.5 hours of symptom onset, one had a localized dissection in the ascending aorta, another had a ventricular thrombus, and a third had an atrial appendage blood clot.
Data source: Prospective investigation of 20 patients.
Disclosures: The work was funded by the Singapore Ministry of Health’s National Medical Research Council. The investigators have no relevant disclosures.
Infant Egg Introduction Can Prevent Sensitization at 12 Months
LOS ANGELES – Among infants at risk for allergic disease, egg introduction at 4 months cuts the risk of egg sensitization at 12 months by about half, according a randomized, placebo-controlled, double blind trial from Australia.
“This is what we hoped to find.” Introducing egg early “is certainly safe, and it may promote tolerance,” said senior investigator Dr. Dianne Campbell, professor and chair of pediatric allergy and clinical immunology at the Children’s Hospital at Westmead, which is affiliated with the University of Sydney.
Four-month-old children were randomized to 350 mg of pasteurized raw whole egg powder or – as a control – rice powder sprinkled once daily on their weaning food until month 8, at which time parents in both groups were encouraged to add eggs to their children’s diets. At least one of each child’s parents had a history of atopic disease, including asthma, eczema, hay fever, or food allergy. Even so, all of the infants had negative (less than 2 mm) skin prick tests (SPTs) at baseline. Compliance by parent diary was 89% in the rice and 81% in the egg groups.
At 12 months, SPTs were positive (3 mm or more) for whole egg in 25 of 122 (20%) children in the rice group, but only 13 of 122 (11%) in the egg group (odds ratio, 0.46; 95% confidence interval, 0.22-0.95; P = .03). Whole egg IgG4 and IgG4/IgE ratios to egg, ovalbumin, and ovomucoid were also higher in the egg group, indicating developing tolerance (P less than .0001 for each).
About 10% of the children originally in the egg group broke out in hives after their first few doses, and were withdrawn from the study. “This intervention may not be for everybody. There will be individuals who react” and it’s impossible, at this point, to predict who they will be. “We cannot prevent allergy in everyone,” said lead investigator Dr. John Tan, a pediatric immunologist at the hospital.
Overall, however, early introduction was safe. There was no anaphylaxis in the trial, and no cardiovascular or respiratory complications. Rates of eczema and peanut allergy were similar at 12 months between the two groups, meaning that early egg introduction did not increase the risk of atopy.
The findings echo results from several recent pediatric egg allergy studies, as well as findings from recent peanut trials. Slowly, it’s becoming clear that delaying the introduction of at least some allergenic foods – a common practice for years – doesn’t prevent allergies and may, in fact, promote them.
Despite those findings, there remains “a big disconnect between the [new] research and what we [still] recommend” in Australia, the United States, and elsewhere. Delaying food introductions was medical “dogma for 20 years, from highly esteemed societies,” and it corresponded with a marked increase in food allergies, but “it’s very hard to turn these things around,” Dr. Campbell said at the American Academy of Allergy, Asthma, and Immunology annual meeting.
The Australian government is reworking its infant feeding guidelines to incorporate the new evidence. “Our revised guidelines will say that there’s strong evidence for peanut and moderate evidence for egg” in favor of early introduction in children who are not sensitized by 4 or so months old, she said.
The trial was powered to detect differences in SPT, not actual egg allergies, which were diagnosed in 13 children (11%) in the rice group and eight (7%) in the egg group; the difference was not statistically significant. “Not all kids who are sensitized will be allergic,” she noted.
The study groups were well matched; there were about equal numbers of boys and girls in each, and, in both groups, about 15% of children were exposed to second hand smoke at home and almost all were breastfed.
The work was funded by the Australian government, among others. The investigators have no disclosures.
LOS ANGELES – Among infants at risk for allergic disease, egg introduction at 4 months cuts the risk of egg sensitization at 12 months by about half, according a randomized, placebo-controlled, double blind trial from Australia.
“This is what we hoped to find.” Introducing egg early “is certainly safe, and it may promote tolerance,” said senior investigator Dr. Dianne Campbell, professor and chair of pediatric allergy and clinical immunology at the Children’s Hospital at Westmead, which is affiliated with the University of Sydney.
Four-month-old children were randomized to 350 mg of pasteurized raw whole egg powder or – as a control – rice powder sprinkled once daily on their weaning food until month 8, at which time parents in both groups were encouraged to add eggs to their children’s diets. At least one of each child’s parents had a history of atopic disease, including asthma, eczema, hay fever, or food allergy. Even so, all of the infants had negative (less than 2 mm) skin prick tests (SPTs) at baseline. Compliance by parent diary was 89% in the rice and 81% in the egg groups.
At 12 months, SPTs were positive (3 mm or more) for whole egg in 25 of 122 (20%) children in the rice group, but only 13 of 122 (11%) in the egg group (odds ratio, 0.46; 95% confidence interval, 0.22-0.95; P = .03). Whole egg IgG4 and IgG4/IgE ratios to egg, ovalbumin, and ovomucoid were also higher in the egg group, indicating developing tolerance (P less than .0001 for each).
About 10% of the children originally in the egg group broke out in hives after their first few doses, and were withdrawn from the study. “This intervention may not be for everybody. There will be individuals who react” and it’s impossible, at this point, to predict who they will be. “We cannot prevent allergy in everyone,” said lead investigator Dr. John Tan, a pediatric immunologist at the hospital.
Overall, however, early introduction was safe. There was no anaphylaxis in the trial, and no cardiovascular or respiratory complications. Rates of eczema and peanut allergy were similar at 12 months between the two groups, meaning that early egg introduction did not increase the risk of atopy.
The findings echo results from several recent pediatric egg allergy studies, as well as findings from recent peanut trials. Slowly, it’s becoming clear that delaying the introduction of at least some allergenic foods – a common practice for years – doesn’t prevent allergies and may, in fact, promote them.
Despite those findings, there remains “a big disconnect between the [new] research and what we [still] recommend” in Australia, the United States, and elsewhere. Delaying food introductions was medical “dogma for 20 years, from highly esteemed societies,” and it corresponded with a marked increase in food allergies, but “it’s very hard to turn these things around,” Dr. Campbell said at the American Academy of Allergy, Asthma, and Immunology annual meeting.
The Australian government is reworking its infant feeding guidelines to incorporate the new evidence. “Our revised guidelines will say that there’s strong evidence for peanut and moderate evidence for egg” in favor of early introduction in children who are not sensitized by 4 or so months old, she said.
The trial was powered to detect differences in SPT, not actual egg allergies, which were diagnosed in 13 children (11%) in the rice group and eight (7%) in the egg group; the difference was not statistically significant. “Not all kids who are sensitized will be allergic,” she noted.
The study groups were well matched; there were about equal numbers of boys and girls in each, and, in both groups, about 15% of children were exposed to second hand smoke at home and almost all were breastfed.
The work was funded by the Australian government, among others. The investigators have no disclosures.
LOS ANGELES – Among infants at risk for allergic disease, egg introduction at 4 months cuts the risk of egg sensitization at 12 months by about half, according a randomized, placebo-controlled, double blind trial from Australia.
“This is what we hoped to find.” Introducing egg early “is certainly safe, and it may promote tolerance,” said senior investigator Dr. Dianne Campbell, professor and chair of pediatric allergy and clinical immunology at the Children’s Hospital at Westmead, which is affiliated with the University of Sydney.
Four-month-old children were randomized to 350 mg of pasteurized raw whole egg powder or – as a control – rice powder sprinkled once daily on their weaning food until month 8, at which time parents in both groups were encouraged to add eggs to their children’s diets. At least one of each child’s parents had a history of atopic disease, including asthma, eczema, hay fever, or food allergy. Even so, all of the infants had negative (less than 2 mm) skin prick tests (SPTs) at baseline. Compliance by parent diary was 89% in the rice and 81% in the egg groups.
At 12 months, SPTs were positive (3 mm or more) for whole egg in 25 of 122 (20%) children in the rice group, but only 13 of 122 (11%) in the egg group (odds ratio, 0.46; 95% confidence interval, 0.22-0.95; P = .03). Whole egg IgG4 and IgG4/IgE ratios to egg, ovalbumin, and ovomucoid were also higher in the egg group, indicating developing tolerance (P less than .0001 for each).
About 10% of the children originally in the egg group broke out in hives after their first few doses, and were withdrawn from the study. “This intervention may not be for everybody. There will be individuals who react” and it’s impossible, at this point, to predict who they will be. “We cannot prevent allergy in everyone,” said lead investigator Dr. John Tan, a pediatric immunologist at the hospital.
Overall, however, early introduction was safe. There was no anaphylaxis in the trial, and no cardiovascular or respiratory complications. Rates of eczema and peanut allergy were similar at 12 months between the two groups, meaning that early egg introduction did not increase the risk of atopy.
The findings echo results from several recent pediatric egg allergy studies, as well as findings from recent peanut trials. Slowly, it’s becoming clear that delaying the introduction of at least some allergenic foods – a common practice for years – doesn’t prevent allergies and may, in fact, promote them.
Despite those findings, there remains “a big disconnect between the [new] research and what we [still] recommend” in Australia, the United States, and elsewhere. Delaying food introductions was medical “dogma for 20 years, from highly esteemed societies,” and it corresponded with a marked increase in food allergies, but “it’s very hard to turn these things around,” Dr. Campbell said at the American Academy of Allergy, Asthma, and Immunology annual meeting.
The Australian government is reworking its infant feeding guidelines to incorporate the new evidence. “Our revised guidelines will say that there’s strong evidence for peanut and moderate evidence for egg” in favor of early introduction in children who are not sensitized by 4 or so months old, she said.
The trial was powered to detect differences in SPT, not actual egg allergies, which were diagnosed in 13 children (11%) in the rice group and eight (7%) in the egg group; the difference was not statistically significant. “Not all kids who are sensitized will be allergic,” she noted.
The study groups were well matched; there were about equal numbers of boys and girls in each, and, in both groups, about 15% of children were exposed to second hand smoke at home and almost all were breastfed.
The work was funded by the Australian government, among others. The investigators have no disclosures.
AT 2016 AAAAI ANNUAL MEETING
Infant Egg Introduction Can Prevent Sensitization at 12 Months
LOS ANGELES – Among infants at risk for allergic disease, egg introduction at 4 months cuts the risk of egg sensitization at 12 months by about half, according a randomized, placebo-controlled, double blind trial from Australia.
“This is what we hoped to find.” Introducing egg early “is certainly safe, and it may promote tolerance,” said senior investigator Dr. Dianne Campbell, professor and chair of pediatric allergy and clinical immunology at the Children’s Hospital at Westmead, which is affiliated with the University of Sydney.
Four-month-old children were randomized to 350 mg of pasteurized raw whole egg powder or – as a control – rice powder sprinkled once daily on their weaning food until month 8, at which time parents in both groups were encouraged to add eggs to their children’s diets. At least one of each child’s parents had a history of atopic disease, including asthma, eczema, hay fever, or food allergy. Even so, all of the infants had negative (less than 2 mm) skin prick tests (SPTs) at baseline. Compliance by parent diary was 89% in the rice and 81% in the egg groups.
At 12 months, SPTs were positive (3 mm or more) for whole egg in 25 of 122 (20%) children in the rice group, but only 13 of 122 (11%) in the egg group (odds ratio, 0.46; 95% confidence interval, 0.22-0.95; P = .03). Whole egg IgG4 and IgG4/IgE ratios to egg, ovalbumin, and ovomucoid were also higher in the egg group, indicating developing tolerance (P less than .0001 for each).
About 10% of the children originally in the egg group broke out in hives after their first few doses, and were withdrawn from the study. “This intervention may not be for everybody. There will be individuals who react” and it’s impossible, at this point, to predict who they will be. “We cannot prevent allergy in everyone,” said lead investigator Dr. John Tan, a pediatric immunologist at the hospital.
Overall, however, early introduction was safe. There was no anaphylaxis in the trial, and no cardiovascular or respiratory complications. Rates of eczema and peanut allergy were similar at 12 months between the two groups, meaning that early egg introduction did not increase the risk of atopy.
The findings echo results from several recent pediatric egg allergy studies, as well as findings from recent peanut trials. Slowly, it’s becoming clear that delaying the introduction of at least some allergenic foods – a common practice for years – doesn’t prevent allergies and may, in fact, promote them.
Despite those findings, there remains “a big disconnect between the [new] research and what we [still] recommend” in Australia, the United States, and elsewhere. Delaying food introductions was medical “dogma for 20 years, from highly esteemed societies,” and it corresponded with a marked increase in food allergies, but “it’s very hard to turn these things around,” Dr. Campbell said at the American Academy of Allergy, Asthma, and Immunology annual meeting.
The Australian government is reworking its infant feeding guidelines to incorporate the new evidence. “Our revised guidelines will say that there’s strong evidence for peanut and moderate evidence for egg” in favor of early introduction in children who are not sensitized by 4 or so months old, she said.
The trial was powered to detect differences in SPT, not actual egg allergies, which were diagnosed in 13 children (11%) in the rice group and eight (7%) in the egg group; the difference was not statistically significant. “Not all kids who are sensitized will be allergic,” she noted.
The study groups were well matched; there were about equal numbers of boys and girls in each, and, in both groups, about 15% of children were exposed to second hand smoke at home and almost all were breastfed.
The work was funded by the Australian government, among others. The investigators have no disclosures.
LOS ANGELES – Among infants at risk for allergic disease, egg introduction at 4 months cuts the risk of egg sensitization at 12 months by about half, according a randomized, placebo-controlled, double blind trial from Australia.
“This is what we hoped to find.” Introducing egg early “is certainly safe, and it may promote tolerance,” said senior investigator Dr. Dianne Campbell, professor and chair of pediatric allergy and clinical immunology at the Children’s Hospital at Westmead, which is affiliated with the University of Sydney.
Four-month-old children were randomized to 350 mg of pasteurized raw whole egg powder or – as a control – rice powder sprinkled once daily on their weaning food until month 8, at which time parents in both groups were encouraged to add eggs to their children’s diets. At least one of each child’s parents had a history of atopic disease, including asthma, eczema, hay fever, or food allergy. Even so, all of the infants had negative (less than 2 mm) skin prick tests (SPTs) at baseline. Compliance by parent diary was 89% in the rice and 81% in the egg groups.
At 12 months, SPTs were positive (3 mm or more) for whole egg in 25 of 122 (20%) children in the rice group, but only 13 of 122 (11%) in the egg group (odds ratio, 0.46; 95% confidence interval, 0.22-0.95; P = .03). Whole egg IgG4 and IgG4/IgE ratios to egg, ovalbumin, and ovomucoid were also higher in the egg group, indicating developing tolerance (P less than .0001 for each).
About 10% of the children originally in the egg group broke out in hives after their first few doses, and were withdrawn from the study. “This intervention may not be for everybody. There will be individuals who react” and it’s impossible, at this point, to predict who they will be. “We cannot prevent allergy in everyone,” said lead investigator Dr. John Tan, a pediatric immunologist at the hospital.
Overall, however, early introduction was safe. There was no anaphylaxis in the trial, and no cardiovascular or respiratory complications. Rates of eczema and peanut allergy were similar at 12 months between the two groups, meaning that early egg introduction did not increase the risk of atopy.
The findings echo results from several recent pediatric egg allergy studies, as well as findings from recent peanut trials. Slowly, it’s becoming clear that delaying the introduction of at least some allergenic foods – a common practice for years – doesn’t prevent allergies and may, in fact, promote them.
Despite those findings, there remains “a big disconnect between the [new] research and what we [still] recommend” in Australia, the United States, and elsewhere. Delaying food introductions was medical “dogma for 20 years, from highly esteemed societies,” and it corresponded with a marked increase in food allergies, but “it’s very hard to turn these things around,” Dr. Campbell said at the American Academy of Allergy, Asthma, and Immunology annual meeting.
The Australian government is reworking its infant feeding guidelines to incorporate the new evidence. “Our revised guidelines will say that there’s strong evidence for peanut and moderate evidence for egg” in favor of early introduction in children who are not sensitized by 4 or so months old, she said.
The trial was powered to detect differences in SPT, not actual egg allergies, which were diagnosed in 13 children (11%) in the rice group and eight (7%) in the egg group; the difference was not statistically significant. “Not all kids who are sensitized will be allergic,” she noted.
The study groups were well matched; there were about equal numbers of boys and girls in each, and, in both groups, about 15% of children were exposed to second hand smoke at home and almost all were breastfed.
The work was funded by the Australian government, among others. The investigators have no disclosures.
LOS ANGELES – Among infants at risk for allergic disease, egg introduction at 4 months cuts the risk of egg sensitization at 12 months by about half, according a randomized, placebo-controlled, double blind trial from Australia.
“This is what we hoped to find.” Introducing egg early “is certainly safe, and it may promote tolerance,” said senior investigator Dr. Dianne Campbell, professor and chair of pediatric allergy and clinical immunology at the Children’s Hospital at Westmead, which is affiliated with the University of Sydney.
Four-month-old children were randomized to 350 mg of pasteurized raw whole egg powder or – as a control – rice powder sprinkled once daily on their weaning food until month 8, at which time parents in both groups were encouraged to add eggs to their children’s diets. At least one of each child’s parents had a history of atopic disease, including asthma, eczema, hay fever, or food allergy. Even so, all of the infants had negative (less than 2 mm) skin prick tests (SPTs) at baseline. Compliance by parent diary was 89% in the rice and 81% in the egg groups.
At 12 months, SPTs were positive (3 mm or more) for whole egg in 25 of 122 (20%) children in the rice group, but only 13 of 122 (11%) in the egg group (odds ratio, 0.46; 95% confidence interval, 0.22-0.95; P = .03). Whole egg IgG4 and IgG4/IgE ratios to egg, ovalbumin, and ovomucoid were also higher in the egg group, indicating developing tolerance (P less than .0001 for each).
About 10% of the children originally in the egg group broke out in hives after their first few doses, and were withdrawn from the study. “This intervention may not be for everybody. There will be individuals who react” and it’s impossible, at this point, to predict who they will be. “We cannot prevent allergy in everyone,” said lead investigator Dr. John Tan, a pediatric immunologist at the hospital.
Overall, however, early introduction was safe. There was no anaphylaxis in the trial, and no cardiovascular or respiratory complications. Rates of eczema and peanut allergy were similar at 12 months between the two groups, meaning that early egg introduction did not increase the risk of atopy.
The findings echo results from several recent pediatric egg allergy studies, as well as findings from recent peanut trials. Slowly, it’s becoming clear that delaying the introduction of at least some allergenic foods – a common practice for years – doesn’t prevent allergies and may, in fact, promote them.
Despite those findings, there remains “a big disconnect between the [new] research and what we [still] recommend” in Australia, the United States, and elsewhere. Delaying food introductions was medical “dogma for 20 years, from highly esteemed societies,” and it corresponded with a marked increase in food allergies, but “it’s very hard to turn these things around,” Dr. Campbell said at the American Academy of Allergy, Asthma, and Immunology annual meeting.
The Australian government is reworking its infant feeding guidelines to incorporate the new evidence. “Our revised guidelines will say that there’s strong evidence for peanut and moderate evidence for egg” in favor of early introduction in children who are not sensitized by 4 or so months old, she said.
The trial was powered to detect differences in SPT, not actual egg allergies, which were diagnosed in 13 children (11%) in the rice group and eight (7%) in the egg group; the difference was not statistically significant. “Not all kids who are sensitized will be allergic,” she noted.
The study groups were well matched; there were about equal numbers of boys and girls in each, and, in both groups, about 15% of children were exposed to second hand smoke at home and almost all were breastfed.
The work was funded by the Australian government, among others. The investigators have no disclosures.
AT 2016 AAAAI ANNUAL MEETING
Infant egg introduction can prevent sensitization at 12 months
LOS ANGELES – Among infants at risk for allergic disease, egg introduction at 4 months cuts the risk of egg sensitization at 12 months by about half, according a randomized, placebo-controlled, double blind trial from Australia.
“This is what we hoped to find.” Introducing egg early “is certainly safe, and it may promote tolerance,” said senior investigator Dr. Dianne Campbell, professor and chair of pediatric allergy and clinical immunology at the Children’s Hospital at Westmead, which is affiliated with the University of Sydney.
Four-month-old children were randomized to 350 mg of pasteurized raw whole egg powder or – as a control – rice powder sprinkled once daily on their weaning food until month 8, at which time parents in both groups were encouraged to add eggs to their children’s diets. At least one of each child’s parents had a history of atopic disease, including asthma, eczema, hay fever, or food allergy. Even so, all of the infants had negative (less than 2 mm) skin prick tests (SPTs) at baseline. Compliance by parent diary was 89% in the rice and 81% in the egg groups.
At 12 months, SPTs were positive (3 mm or more) for whole egg in 25 of 122 (20%) children in the rice group, but only 13 of 122 (11%) in the egg group (odds ratio, 0.46; 95% confidence interval, 0.22-0.95; P = .03). Whole egg IgG4 and IgG4/IgE ratios to egg, ovalbumin, and ovomucoid were also higher in the egg group, indicating developing tolerance (P less than .0001 for each).
About 10% of the children originally in the egg group broke out in hives after their first few doses, and were withdrawn from the study. “This intervention may not be for everybody. There will be individuals who react” and it’s impossible, at this point, to predict who they will be. “We cannot prevent allergy in everyone,” said lead investigator Dr. John Tan, a pediatric immunologist at the hospital.
Overall, however, early introduction was safe. There was no anaphylaxis in the trial, and no cardiovascular or respiratory complications. Rates of eczema and peanut allergy were similar at 12 months between the two groups, meaning that early egg introduction did not increase the risk of atopy.
The findings echo results from several recent pediatric egg allergy studies, as well as findings from recent peanut trials. Slowly, it’s becoming clear that delaying the introduction of at least some allergenic foods – a common practice for years – doesn’t prevent allergies and may, in fact, promote them.
Despite those findings, there remains “a big disconnect between the [new] research and what we [still] recommend” in Australia, the United States, and elsewhere. Delaying food introductions was medical “dogma for 20 years, from highly esteemed societies,” and it corresponded with a marked increase in food allergies, but “it’s very hard to turn these things around,” Dr. Campbell said at the American Academy of Allergy, Asthma, and Immunology annual meeting.
The Australian government is reworking its infant feeding guidelines to incorporate the new evidence. “Our revised guidelines will say that there’s strong evidence for peanut and moderate evidence for egg” in favor of early introduction in children who are not sensitized by 4 or so months old, she said.
The trial was powered to detect differences in SPT, not actual egg allergies, which were diagnosed in 13 children (11%) in the rice group and eight (7%) in the egg group; the difference was not statistically significant. “Not all kids who are sensitized will be allergic,” she noted.
The study groups were well matched; there were about equal numbers of boys and girls in each, and, in both groups, about 15% of children were exposed to second hand smoke at home and almost all were breastfed.
The work was funded by the Australian government, among others. The investigators have no disclosures.
LOS ANGELES – Among infants at risk for allergic disease, egg introduction at 4 months cuts the risk of egg sensitization at 12 months by about half, according a randomized, placebo-controlled, double blind trial from Australia.
“This is what we hoped to find.” Introducing egg early “is certainly safe, and it may promote tolerance,” said senior investigator Dr. Dianne Campbell, professor and chair of pediatric allergy and clinical immunology at the Children’s Hospital at Westmead, which is affiliated with the University of Sydney.
Four-month-old children were randomized to 350 mg of pasteurized raw whole egg powder or – as a control – rice powder sprinkled once daily on their weaning food until month 8, at which time parents in both groups were encouraged to add eggs to their children’s diets. At least one of each child’s parents had a history of atopic disease, including asthma, eczema, hay fever, or food allergy. Even so, all of the infants had negative (less than 2 mm) skin prick tests (SPTs) at baseline. Compliance by parent diary was 89% in the rice and 81% in the egg groups.
At 12 months, SPTs were positive (3 mm or more) for whole egg in 25 of 122 (20%) children in the rice group, but only 13 of 122 (11%) in the egg group (odds ratio, 0.46; 95% confidence interval, 0.22-0.95; P = .03). Whole egg IgG4 and IgG4/IgE ratios to egg, ovalbumin, and ovomucoid were also higher in the egg group, indicating developing tolerance (P less than .0001 for each).
About 10% of the children originally in the egg group broke out in hives after their first few doses, and were withdrawn from the study. “This intervention may not be for everybody. There will be individuals who react” and it’s impossible, at this point, to predict who they will be. “We cannot prevent allergy in everyone,” said lead investigator Dr. John Tan, a pediatric immunologist at the hospital.
Overall, however, early introduction was safe. There was no anaphylaxis in the trial, and no cardiovascular or respiratory complications. Rates of eczema and peanut allergy were similar at 12 months between the two groups, meaning that early egg introduction did not increase the risk of atopy.
The findings echo results from several recent pediatric egg allergy studies, as well as findings from recent peanut trials. Slowly, it’s becoming clear that delaying the introduction of at least some allergenic foods – a common practice for years – doesn’t prevent allergies and may, in fact, promote them.
Despite those findings, there remains “a big disconnect between the [new] research and what we [still] recommend” in Australia, the United States, and elsewhere. Delaying food introductions was medical “dogma for 20 years, from highly esteemed societies,” and it corresponded with a marked increase in food allergies, but “it’s very hard to turn these things around,” Dr. Campbell said at the American Academy of Allergy, Asthma, and Immunology annual meeting.
The Australian government is reworking its infant feeding guidelines to incorporate the new evidence. “Our revised guidelines will say that there’s strong evidence for peanut and moderate evidence for egg” in favor of early introduction in children who are not sensitized by 4 or so months old, she said.
The trial was powered to detect differences in SPT, not actual egg allergies, which were diagnosed in 13 children (11%) in the rice group and eight (7%) in the egg group; the difference was not statistically significant. “Not all kids who are sensitized will be allergic,” she noted.
The study groups were well matched; there were about equal numbers of boys and girls in each, and, in both groups, about 15% of children were exposed to second hand smoke at home and almost all were breastfed.
The work was funded by the Australian government, among others. The investigators have no disclosures.
LOS ANGELES – Among infants at risk for allergic disease, egg introduction at 4 months cuts the risk of egg sensitization at 12 months by about half, according a randomized, placebo-controlled, double blind trial from Australia.
“This is what we hoped to find.” Introducing egg early “is certainly safe, and it may promote tolerance,” said senior investigator Dr. Dianne Campbell, professor and chair of pediatric allergy and clinical immunology at the Children’s Hospital at Westmead, which is affiliated with the University of Sydney.
Four-month-old children were randomized to 350 mg of pasteurized raw whole egg powder or – as a control – rice powder sprinkled once daily on their weaning food until month 8, at which time parents in both groups were encouraged to add eggs to their children’s diets. At least one of each child’s parents had a history of atopic disease, including asthma, eczema, hay fever, or food allergy. Even so, all of the infants had negative (less than 2 mm) skin prick tests (SPTs) at baseline. Compliance by parent diary was 89% in the rice and 81% in the egg groups.
At 12 months, SPTs were positive (3 mm or more) for whole egg in 25 of 122 (20%) children in the rice group, but only 13 of 122 (11%) in the egg group (odds ratio, 0.46; 95% confidence interval, 0.22-0.95; P = .03). Whole egg IgG4 and IgG4/IgE ratios to egg, ovalbumin, and ovomucoid were also higher in the egg group, indicating developing tolerance (P less than .0001 for each).
About 10% of the children originally in the egg group broke out in hives after their first few doses, and were withdrawn from the study. “This intervention may not be for everybody. There will be individuals who react” and it’s impossible, at this point, to predict who they will be. “We cannot prevent allergy in everyone,” said lead investigator Dr. John Tan, a pediatric immunologist at the hospital.
Overall, however, early introduction was safe. There was no anaphylaxis in the trial, and no cardiovascular or respiratory complications. Rates of eczema and peanut allergy were similar at 12 months between the two groups, meaning that early egg introduction did not increase the risk of atopy.
The findings echo results from several recent pediatric egg allergy studies, as well as findings from recent peanut trials. Slowly, it’s becoming clear that delaying the introduction of at least some allergenic foods – a common practice for years – doesn’t prevent allergies and may, in fact, promote them.
Despite those findings, there remains “a big disconnect between the [new] research and what we [still] recommend” in Australia, the United States, and elsewhere. Delaying food introductions was medical “dogma for 20 years, from highly esteemed societies,” and it corresponded with a marked increase in food allergies, but “it’s very hard to turn these things around,” Dr. Campbell said at the American Academy of Allergy, Asthma, and Immunology annual meeting.
The Australian government is reworking its infant feeding guidelines to incorporate the new evidence. “Our revised guidelines will say that there’s strong evidence for peanut and moderate evidence for egg” in favor of early introduction in children who are not sensitized by 4 or so months old, she said.
The trial was powered to detect differences in SPT, not actual egg allergies, which were diagnosed in 13 children (11%) in the rice group and eight (7%) in the egg group; the difference was not statistically significant. “Not all kids who are sensitized will be allergic,” she noted.
The study groups were well matched; there were about equal numbers of boys and girls in each, and, in both groups, about 15% of children were exposed to second hand smoke at home and almost all were breastfed.
The work was funded by the Australian government, among others. The investigators have no disclosures.
AT 2016 AAAAI ANNUAL MEETING
Key clinical point: If at-risk infants have negative skin prick tests (SPTs) at 4 months, tell their moms to introduce egg into their weaning diets.
Major finding: At 12 months, SPTs were positive (3 mm or more) for whole egg in 25 of 122 children (20%) in the rice group, but only 13 of 122 (11%) in the egg group (odds ratio, 0.46; 95% confidence interval, 0.22-0.95; P = .03).
Data source: Randomized clinical trial or 244 infants at risk for egg allergy.
Disclosures: The work was funded by the Australian government, among others. The investigators have no disclosures.
Even Small Food Doses Maintain Tolerance in Pediatric Oral Immunotherapy
LOS ANGELES – Food doses as low as 300 mg every other day are enough to retain tolerance in the maintenance phase of pediatric oral immunotherapy for food allergies, according to an investigation involving 62 children over 4 years of age.
The flexibility “to take smaller doses and still maintain desensitization” is why “a lot of our patients continued to do regular dosing of their oral immunotherapy” for up to 6 years, said Dr. Sharon Chinthrajah, a pediatric allergist and immunologist at Stanford (Calif.) University.
The children were originally involved in phase I testing of desensitization for multiple food allergies with omalizumab (Xolair). By reducing the risk of anaphylaxis, the biologic facilitated rapid escalation: 30 children on omalizumab tolerated 2-g food challenges by 9 months. It took about 2 years for 43 children to reach that level without omalizumab.
Subjects had up to five allergies from a list of 15, including egg, milk, and peanut. When tolerance was achieved, they stayed on daily 2-g dosing of each of their food allergens for 4-6 months. They and their parents were then given the option of 2-g daily maintenance dosing or dropping down to as low as 300 mg – about the equivalent of one tree nut – every other day.
The investigators reported follow-up data for 62 subjects at the annual meeting of the American Academy of Allergy, Asthma, and Immunology. Nine children on omalizumab and 22 who did not get omalizumab stuck with 2 g–daily dosing, while 18 omalizumab and 13 no-omalizumab children opted for lower maintenance dosing.
They all remained largely tolerant to 2-g challenges every 6 months for up to 46 months in the omalizumab group and 73 months in the no-omalizumab group, the end of follow-up in each group. There were no differences in immunologic parameters and no differences in tolerance testing between the two groups, and tolerance was maintained regardless of the food allergen. Only about 0.5% of reactions in either group were severe.
“We were excited to find that going down to 300 mg was just as protective” and that long-term maintenance dosing is safe, said Dr. Kari Nadeau, professor of pediatric immunology and allergy at the university. “These are important messages. There’s not a lot of follow-up data on food [oral immunotherapy]. Patient flexibility is key to long-term outcomes,” she added.
“I think people who had milk, egg, and wheat allergies probably didn’t reduce their intake during maintenance, since these are the ones they tend to enjoy,” Dr. Chinthrajah said, but the risk of severe reactions remains, “so we still require patients to carry reaction medication, and review autoinjector use when they come back to our center for testing and food challenges.”
There was no industry funding for the work, and the investigators said they have no relevant disclosures.
LOS ANGELES – Food doses as low as 300 mg every other day are enough to retain tolerance in the maintenance phase of pediatric oral immunotherapy for food allergies, according to an investigation involving 62 children over 4 years of age.
The flexibility “to take smaller doses and still maintain desensitization” is why “a lot of our patients continued to do regular dosing of their oral immunotherapy” for up to 6 years, said Dr. Sharon Chinthrajah, a pediatric allergist and immunologist at Stanford (Calif.) University.
The children were originally involved in phase I testing of desensitization for multiple food allergies with omalizumab (Xolair). By reducing the risk of anaphylaxis, the biologic facilitated rapid escalation: 30 children on omalizumab tolerated 2-g food challenges by 9 months. It took about 2 years for 43 children to reach that level without omalizumab.
Subjects had up to five allergies from a list of 15, including egg, milk, and peanut. When tolerance was achieved, they stayed on daily 2-g dosing of each of their food allergens for 4-6 months. They and their parents were then given the option of 2-g daily maintenance dosing or dropping down to as low as 300 mg – about the equivalent of one tree nut – every other day.
The investigators reported follow-up data for 62 subjects at the annual meeting of the American Academy of Allergy, Asthma, and Immunology. Nine children on omalizumab and 22 who did not get omalizumab stuck with 2 g–daily dosing, while 18 omalizumab and 13 no-omalizumab children opted for lower maintenance dosing.
They all remained largely tolerant to 2-g challenges every 6 months for up to 46 months in the omalizumab group and 73 months in the no-omalizumab group, the end of follow-up in each group. There were no differences in immunologic parameters and no differences in tolerance testing between the two groups, and tolerance was maintained regardless of the food allergen. Only about 0.5% of reactions in either group were severe.
“We were excited to find that going down to 300 mg was just as protective” and that long-term maintenance dosing is safe, said Dr. Kari Nadeau, professor of pediatric immunology and allergy at the university. “These are important messages. There’s not a lot of follow-up data on food [oral immunotherapy]. Patient flexibility is key to long-term outcomes,” she added.
“I think people who had milk, egg, and wheat allergies probably didn’t reduce their intake during maintenance, since these are the ones they tend to enjoy,” Dr. Chinthrajah said, but the risk of severe reactions remains, “so we still require patients to carry reaction medication, and review autoinjector use when they come back to our center for testing and food challenges.”
There was no industry funding for the work, and the investigators said they have no relevant disclosures.
LOS ANGELES – Food doses as low as 300 mg every other day are enough to retain tolerance in the maintenance phase of pediatric oral immunotherapy for food allergies, according to an investigation involving 62 children over 4 years of age.
The flexibility “to take smaller doses and still maintain desensitization” is why “a lot of our patients continued to do regular dosing of their oral immunotherapy” for up to 6 years, said Dr. Sharon Chinthrajah, a pediatric allergist and immunologist at Stanford (Calif.) University.
The children were originally involved in phase I testing of desensitization for multiple food allergies with omalizumab (Xolair). By reducing the risk of anaphylaxis, the biologic facilitated rapid escalation: 30 children on omalizumab tolerated 2-g food challenges by 9 months. It took about 2 years for 43 children to reach that level without omalizumab.
Subjects had up to five allergies from a list of 15, including egg, milk, and peanut. When tolerance was achieved, they stayed on daily 2-g dosing of each of their food allergens for 4-6 months. They and their parents were then given the option of 2-g daily maintenance dosing or dropping down to as low as 300 mg – about the equivalent of one tree nut – every other day.
The investigators reported follow-up data for 62 subjects at the annual meeting of the American Academy of Allergy, Asthma, and Immunology. Nine children on omalizumab and 22 who did not get omalizumab stuck with 2 g–daily dosing, while 18 omalizumab and 13 no-omalizumab children opted for lower maintenance dosing.
They all remained largely tolerant to 2-g challenges every 6 months for up to 46 months in the omalizumab group and 73 months in the no-omalizumab group, the end of follow-up in each group. There were no differences in immunologic parameters and no differences in tolerance testing between the two groups, and tolerance was maintained regardless of the food allergen. Only about 0.5% of reactions in either group were severe.
“We were excited to find that going down to 300 mg was just as protective” and that long-term maintenance dosing is safe, said Dr. Kari Nadeau, professor of pediatric immunology and allergy at the university. “These are important messages. There’s not a lot of follow-up data on food [oral immunotherapy]. Patient flexibility is key to long-term outcomes,” she added.
“I think people who had milk, egg, and wheat allergies probably didn’t reduce their intake during maintenance, since these are the ones they tend to enjoy,” Dr. Chinthrajah said, but the risk of severe reactions remains, “so we still require patients to carry reaction medication, and review autoinjector use when they come back to our center for testing and food challenges.”
There was no industry funding for the work, and the investigators said they have no relevant disclosures.
AT 2016 AAAAI ANNUAL MEETING
Even Small Food Doses Maintain Tolerance in Pediatric Oral Immunotherapy
LOS ANGELES – Food doses as low as 300 mg every other day are enough to retain tolerance in the maintenance phase of pediatric oral immunotherapy for food allergies, according to an investigation involving 62 children over 4 years of age.
The flexibility “to take smaller doses and still maintain desensitization” is why “a lot of our patients continued to do regular dosing of their oral immunotherapy” for up to 6 years, said Dr. Sharon Chinthrajah, a pediatric allergist and immunologist at Stanford (Calif.) University.
The children were originally involved in phase I testing of desensitization for multiple food allergies with omalizumab (Xolair). By reducing the risk of anaphylaxis, the biologic facilitated rapid escalation: 30 children on omalizumab tolerated 2-g food challenges by 9 months. It took about 2 years for 43 children to reach that level without omalizumab.
Subjects had up to five allergies from a list of 15, including egg, milk, and peanut. When tolerance was achieved, they stayed on daily 2-g dosing of each of their food allergens for 4-6 months. They and their parents were then given the option of 2-g daily maintenance dosing or dropping down to as low as 300 mg – about the equivalent of one tree nut – every other day.
The investigators reported follow-up data for 62 subjects at the annual meeting of the American Academy of Allergy, Asthma, and Immunology. Nine children on omalizumab and 22 who did not get omalizumab stuck with 2 g–daily dosing, while 18 omalizumab and 13 no-omalizumab children opted for lower maintenance dosing.
They all remained largely tolerant to 2-g challenges every 6 months for up to 46 months in the omalizumab group and 73 months in the no-omalizumab group, the end of follow-up in each group. There were no differences in immunologic parameters and no differences in tolerance testing between the two groups, and tolerance was maintained regardless of the food allergen. Only about 0.5% of reactions in either group were severe.
“We were excited to find that going down to 300 mg was just as protective” and that long-term maintenance dosing is safe, said Dr. Kari Nadeau, professor of pediatric immunology and allergy at the university. “These are important messages. There’s not a lot of follow-up data on food [oral immunotherapy]. Patient flexibility is key to long-term outcomes,” she added.
“I think people who had milk, egg, and wheat allergies probably didn’t reduce their intake during maintenance, since these are the ones they tend to enjoy,” Dr. Chinthrajah said, but the risk of severe reactions remains, “so we still require patients to carry reaction medication, and review autoinjector use when they come back to our center for testing and food challenges.”
There was no industry funding for the work, and the investigators said they have no relevant disclosures.
LOS ANGELES – Food doses as low as 300 mg every other day are enough to retain tolerance in the maintenance phase of pediatric oral immunotherapy for food allergies, according to an investigation involving 62 children over 4 years of age.
The flexibility “to take smaller doses and still maintain desensitization” is why “a lot of our patients continued to do regular dosing of their oral immunotherapy” for up to 6 years, said Dr. Sharon Chinthrajah, a pediatric allergist and immunologist at Stanford (Calif.) University.
The children were originally involved in phase I testing of desensitization for multiple food allergies with omalizumab (Xolair). By reducing the risk of anaphylaxis, the biologic facilitated rapid escalation: 30 children on omalizumab tolerated 2-g food challenges by 9 months. It took about 2 years for 43 children to reach that level without omalizumab.
Subjects had up to five allergies from a list of 15, including egg, milk, and peanut. When tolerance was achieved, they stayed on daily 2-g dosing of each of their food allergens for 4-6 months. They and their parents were then given the option of 2-g daily maintenance dosing or dropping down to as low as 300 mg – about the equivalent of one tree nut – every other day.
The investigators reported follow-up data for 62 subjects at the annual meeting of the American Academy of Allergy, Asthma, and Immunology. Nine children on omalizumab and 22 who did not get omalizumab stuck with 2 g–daily dosing, while 18 omalizumab and 13 no-omalizumab children opted for lower maintenance dosing.
They all remained largely tolerant to 2-g challenges every 6 months for up to 46 months in the omalizumab group and 73 months in the no-omalizumab group, the end of follow-up in each group. There were no differences in immunologic parameters and no differences in tolerance testing between the two groups, and tolerance was maintained regardless of the food allergen. Only about 0.5% of reactions in either group were severe.
“We were excited to find that going down to 300 mg was just as protective” and that long-term maintenance dosing is safe, said Dr. Kari Nadeau, professor of pediatric immunology and allergy at the university. “These are important messages. There’s not a lot of follow-up data on food [oral immunotherapy]. Patient flexibility is key to long-term outcomes,” she added.
“I think people who had milk, egg, and wheat allergies probably didn’t reduce their intake during maintenance, since these are the ones they tend to enjoy,” Dr. Chinthrajah said, but the risk of severe reactions remains, “so we still require patients to carry reaction medication, and review autoinjector use when they come back to our center for testing and food challenges.”
There was no industry funding for the work, and the investigators said they have no relevant disclosures.
LOS ANGELES – Food doses as low as 300 mg every other day are enough to retain tolerance in the maintenance phase of pediatric oral immunotherapy for food allergies, according to an investigation involving 62 children over 4 years of age.
The flexibility “to take smaller doses and still maintain desensitization” is why “a lot of our patients continued to do regular dosing of their oral immunotherapy” for up to 6 years, said Dr. Sharon Chinthrajah, a pediatric allergist and immunologist at Stanford (Calif.) University.
The children were originally involved in phase I testing of desensitization for multiple food allergies with omalizumab (Xolair). By reducing the risk of anaphylaxis, the biologic facilitated rapid escalation: 30 children on omalizumab tolerated 2-g food challenges by 9 months. It took about 2 years for 43 children to reach that level without omalizumab.
Subjects had up to five allergies from a list of 15, including egg, milk, and peanut. When tolerance was achieved, they stayed on daily 2-g dosing of each of their food allergens for 4-6 months. They and their parents were then given the option of 2-g daily maintenance dosing or dropping down to as low as 300 mg – about the equivalent of one tree nut – every other day.
The investigators reported follow-up data for 62 subjects at the annual meeting of the American Academy of Allergy, Asthma, and Immunology. Nine children on omalizumab and 22 who did not get omalizumab stuck with 2 g–daily dosing, while 18 omalizumab and 13 no-omalizumab children opted for lower maintenance dosing.
They all remained largely tolerant to 2-g challenges every 6 months for up to 46 months in the omalizumab group and 73 months in the no-omalizumab group, the end of follow-up in each group. There were no differences in immunologic parameters and no differences in tolerance testing between the two groups, and tolerance was maintained regardless of the food allergen. Only about 0.5% of reactions in either group were severe.
“We were excited to find that going down to 300 mg was just as protective” and that long-term maintenance dosing is safe, said Dr. Kari Nadeau, professor of pediatric immunology and allergy at the university. “These are important messages. There’s not a lot of follow-up data on food [oral immunotherapy]. Patient flexibility is key to long-term outcomes,” she added.
“I think people who had milk, egg, and wheat allergies probably didn’t reduce their intake during maintenance, since these are the ones they tend to enjoy,” Dr. Chinthrajah said, but the risk of severe reactions remains, “so we still require patients to carry reaction medication, and review autoinjector use when they come back to our center for testing and food challenges.”
There was no industry funding for the work, and the investigators said they have no relevant disclosures.
AT 2016 AAAAI ANNUAL MEETING
Even small food doses maintain tolerance in pediatric oral immunotherapy
LOS ANGELES – Food doses as low as 300 mg every other day are enough to retain tolerance in the maintenance phase of pediatric oral immunotherapy for food allergies, according to an investigation involving 62 children over 4 years of age.
The flexibility “to take smaller doses and still maintain desensitization” is why “a lot of our patients continued to do regular dosing of their oral immunotherapy” for up to 6 years, said Dr. Sharon Chinthrajah, a pediatric allergist and immunologist at Stanford (Calif.) University.
The children were originally involved in phase I testing of desensitization for multiple food allergies with omalizumab (Xolair). By reducing the risk of anaphylaxis, the biologic facilitated rapid escalation: 30 children on omalizumab tolerated 2-g food challenges by 9 months. It took about 2 years for 43 children to reach that level without omalizumab.
Subjects had up to five allergies from a list of 15, including egg, milk, and peanut. When tolerance was achieved, they stayed on daily 2-g dosing of each of their food allergens for 4-6 months. They and their parents were then given the option of 2-g daily maintenance dosing or dropping down to as low as 300 mg – about the equivalent of one tree nut – every other day.
The investigators reported follow-up data for 62 subjects at the annual meeting of the American Academy of Allergy, Asthma, and Immunology. Nine children on omalizumab and 22 who did not get omalizumab stuck with 2 g–daily dosing, while 18 omalizumab and 13 no-omalizumab children opted for lower maintenance dosing.
They all remained largely tolerant to 2-g challenges every 6 months for up to 46 months in the omalizumab group and 73 months in the no-omalizumab group, the end of follow-up in each group. There were no differences in immunologic parameters and no differences in tolerance testing between the two groups, and tolerance was maintained regardless of the food allergen. Only about 0.5% of reactions in either group were severe.
“We were excited to find that going down to 300 mg was just as protective” and that long-term maintenance dosing is safe, said Dr. Kari Nadeau, professor of pediatric immunology and allergy at the university. “These are important messages. There’s not a lot of follow-up data on food [oral immunotherapy]. Patient flexibility is key to long-term outcomes,” she added.
“I think people who had milk, egg, and wheat allergies probably didn’t reduce their intake during maintenance, since these are the ones they tend to enjoy,” Dr. Chinthrajah said, but the risk of severe reactions remains, “so we still require patients to carry reaction medication, and review autoinjector use when they come back to our center for testing and food challenges.”
There was no industry funding for the work, and the investigators said they have no relevant disclosures.
LOS ANGELES – Food doses as low as 300 mg every other day are enough to retain tolerance in the maintenance phase of pediatric oral immunotherapy for food allergies, according to an investigation involving 62 children over 4 years of age.
The flexibility “to take smaller doses and still maintain desensitization” is why “a lot of our patients continued to do regular dosing of their oral immunotherapy” for up to 6 years, said Dr. Sharon Chinthrajah, a pediatric allergist and immunologist at Stanford (Calif.) University.
The children were originally involved in phase I testing of desensitization for multiple food allergies with omalizumab (Xolair). By reducing the risk of anaphylaxis, the biologic facilitated rapid escalation: 30 children on omalizumab tolerated 2-g food challenges by 9 months. It took about 2 years for 43 children to reach that level without omalizumab.
Subjects had up to five allergies from a list of 15, including egg, milk, and peanut. When tolerance was achieved, they stayed on daily 2-g dosing of each of their food allergens for 4-6 months. They and their parents were then given the option of 2-g daily maintenance dosing or dropping down to as low as 300 mg – about the equivalent of one tree nut – every other day.
The investigators reported follow-up data for 62 subjects at the annual meeting of the American Academy of Allergy, Asthma, and Immunology. Nine children on omalizumab and 22 who did not get omalizumab stuck with 2 g–daily dosing, while 18 omalizumab and 13 no-omalizumab children opted for lower maintenance dosing.
They all remained largely tolerant to 2-g challenges every 6 months for up to 46 months in the omalizumab group and 73 months in the no-omalizumab group, the end of follow-up in each group. There were no differences in immunologic parameters and no differences in tolerance testing between the two groups, and tolerance was maintained regardless of the food allergen. Only about 0.5% of reactions in either group were severe.
“We were excited to find that going down to 300 mg was just as protective” and that long-term maintenance dosing is safe, said Dr. Kari Nadeau, professor of pediatric immunology and allergy at the university. “These are important messages. There’s not a lot of follow-up data on food [oral immunotherapy]. Patient flexibility is key to long-term outcomes,” she added.
“I think people who had milk, egg, and wheat allergies probably didn’t reduce their intake during maintenance, since these are the ones they tend to enjoy,” Dr. Chinthrajah said, but the risk of severe reactions remains, “so we still require patients to carry reaction medication, and review autoinjector use when they come back to our center for testing and food challenges.”
There was no industry funding for the work, and the investigators said they have no relevant disclosures.
LOS ANGELES – Food doses as low as 300 mg every other day are enough to retain tolerance in the maintenance phase of pediatric oral immunotherapy for food allergies, according to an investigation involving 62 children over 4 years of age.
The flexibility “to take smaller doses and still maintain desensitization” is why “a lot of our patients continued to do regular dosing of their oral immunotherapy” for up to 6 years, said Dr. Sharon Chinthrajah, a pediatric allergist and immunologist at Stanford (Calif.) University.
The children were originally involved in phase I testing of desensitization for multiple food allergies with omalizumab (Xolair). By reducing the risk of anaphylaxis, the biologic facilitated rapid escalation: 30 children on omalizumab tolerated 2-g food challenges by 9 months. It took about 2 years for 43 children to reach that level without omalizumab.
Subjects had up to five allergies from a list of 15, including egg, milk, and peanut. When tolerance was achieved, they stayed on daily 2-g dosing of each of their food allergens for 4-6 months. They and their parents were then given the option of 2-g daily maintenance dosing or dropping down to as low as 300 mg – about the equivalent of one tree nut – every other day.
The investigators reported follow-up data for 62 subjects at the annual meeting of the American Academy of Allergy, Asthma, and Immunology. Nine children on omalizumab and 22 who did not get omalizumab stuck with 2 g–daily dosing, while 18 omalizumab and 13 no-omalizumab children opted for lower maintenance dosing.
They all remained largely tolerant to 2-g challenges every 6 months for up to 46 months in the omalizumab group and 73 months in the no-omalizumab group, the end of follow-up in each group. There were no differences in immunologic parameters and no differences in tolerance testing between the two groups, and tolerance was maintained regardless of the food allergen. Only about 0.5% of reactions in either group were severe.
“We were excited to find that going down to 300 mg was just as protective” and that long-term maintenance dosing is safe, said Dr. Kari Nadeau, professor of pediatric immunology and allergy at the university. “These are important messages. There’s not a lot of follow-up data on food [oral immunotherapy]. Patient flexibility is key to long-term outcomes,” she added.
“I think people who had milk, egg, and wheat allergies probably didn’t reduce their intake during maintenance, since these are the ones they tend to enjoy,” Dr. Chinthrajah said, but the risk of severe reactions remains, “so we still require patients to carry reaction medication, and review autoinjector use when they come back to our center for testing and food challenges.”
There was no industry funding for the work, and the investigators said they have no relevant disclosures.
AT 2016 AAAAI ANNUAL MEETING
Key clinical point: Small food doses work as well as large ones to maintain tolerance after oral immunotherapy induction for pediatric food allergies.
Major finding: After induction, children taking daily 2-g maintenance doses and those taking as little as 300 mg every other day both retained tolerance to 2-g challenges every 6 months for 46-73 months.
Data source: Prospective study of 62 children with multiple food allergies.
Disclosures: There was no industry funding for the work, and the investigators said they have no relevant disclosures.
