User login
Waning pertussis immunity may be linked to acellular vaccine
A large Kaiser Permanente study paints a nuanced picture of the acellular pertussis vaccine, with more cases occurring in fully vaccinated children, but the highest risk of disease occurring among the under- and unvaccinated.
Among nearly half a million children, the unvaccinated were 13 times more likely to develop pertussis than fully vaccinated children, Ousseny Zerbo, PhD, of Kaiser Permanente Northern California in Oakland and colleagues wrote in Pediatrics. But 82% of cases occurred in fully vaccinated children and just 5% in undervaccinated children – and rates increased in both groups the farther they were in time from the last vaccination.
“Within our study population, greater than 80% of pertussis cases occurred among age-appropriately vaccinated children,” the team wrote. “Children who were further away from their last DTaP dose were at increased risk of pertussis, even after controlling for undervaccination. Our results suggest that, in this population, possibly in conjunction with other factors not addressed in this study, suboptimal vaccine efficacy and waning [immunity] played a major role in recent pertussis epidemics.”
The results are consistent with several prior studies, including one finding that the odds of the disease increased by 33% for every additional year after the third or fifth DTaP dose (Pediatrics. 2015;135[2]:331-43).
The current study comprised 469,982 children aged between 3 months and 11 years, who were followed for a mean of 4.6 years. Over the entire study period, there were 738 lab-confirmed pertussis cases. Most of these (515; 70%) occurred in fully vaccinated children. Another 99 (13%) occurred in unvaccinated children, 36 (5%) in undervaccinated children, and 88 (12%) in fully vaccinated plus one dose.
In a multivariate analysis, the risk of pertussis was 13 times higher among the unvaccinated (adjusted hazard ratio, 13) and almost 2 times higher among the undervaccinated (aHR, 1.9), compared with fully vaccinated children. Those who had been fully vaccinated and received a booster had the lowest risk, about half that of fully vaccinated children (aHR, 0.48).
Risk varied according to age, but also was significantly higher among unvaccinated children at each time point. Risk ranged from 4 times higher among those aged 3-5 months to 23 times higher among those aged 19-84 months. Undervaccinated children aged 5-7 months and 19-84 months also were at significantly increased risk for pertussis, compared with fully vaccinated children. Children who were fully vaccinated plus one dose had a significantly reduced risk at 7-19 months and at 19-84 months, compared with the fully vaccinated reference group.
“Across all follow-up and all age groups, VE [vaccine effectiveness] was 86% ... for undervaccinated children, compared with unvaccinated children,” Dr. Zerbo and associates wrote. “VE was even higher for fully vaccinated children [93%] and for those who were fully vaccinated plus one dose [96%].”
But VE waned as time progressed farther from the last DTaP dose. The multivariate model found more than a 100% increased risk for those whose last DTaP was at least 3 years past, compared with less than 1 year past (aHR, 2.58).
The model also found time-bound risk increases among fully vaccinated children, with a more than 300% increased risk among those at least 6 years out from the last DTaP dose, compared with 3 years out (aHR, 4.66).
The results indicate that other factors besides adherence to the recommended vaccine schedule may be at work in recent pertussis outbreaks.
“Although waning immunity is clearly an important factor driving pertussis epidemics in recent years, other factors that we did not evaluate in this study might also contribute to pertussis epidemics individually or in synergy,” Dr. Zerbo and associates wrote. “Results from studies in baboons suggest that the acellular pertussis vaccines are unable to prevent colonization, carriage, and transmission. If this is also true for humans, this could contribute to pertussis epidemics. The causes of recent pertussis epidemics are complex, and we were only able to address some aspects in our study.”
The study was funded by Kaiser Permanente Northern California, the National Institutes of Health, and in part by a National Institute of Allergy and Infectious Diseases grant. One coauthor reported receiving research grant support from Sanofi Pasteur, Novartis, GlaxoSmithKline, Merck, MedImmune, Pfizer, and Dynavax for unrelated studies; the other authors reported no relevant financial disclosures.
SOURCE: Zerbo O et al. Pediatrics. 2019 Jun 10. doi: 10.1542/peds.2018-3466.
Fixing one problem with the pertussis vaccine seemed to have created another, Kathryn M. Edwards, MD, wrote in an accompanying editorial.
The current acellular vaccine was approved in 1997. It was considered a less reactive substitute for the previous whole-cell vaccine, which was associated with injection site pain, swelling, fever, and febrile seizures, Dr. Edwards wrote. “For about a decade, all seemed to be going well with pertussis control. Serological methods were employed to diagnose pertussis infections in adolescents and adults, and polymerase chain reaction methods were devised to more accurately detect pertussis organisms. Thus, the burden of pertussis disease was increasingly appreciated as the diagnostic methods improved.”
But things soon changed. There were pertussis outbreaks, some of them quite large. The increasing disease rates showed that protection conferred by the acellular vaccine waned much more quickly than that conferred by the whole-cell vaccine. “In the current study, Zerbo et al. add to the body of evidence documenting the increase in pertussis risk with time after DTaP vaccination,” she noted.
This has several practical implications, Dr. Edwards wrote.
“First, given the markedly increased risk of pertussis in unvaccinated and undervaccinated children, universal DTaP vaccination should be strongly recommended. Second, the addition of maternal Tdap vaccination administered during pregnancy has been shown to significantly reduce infant disease before primary immunization and should remain the standard,” Dr. Edwards wrote.
More problematic is how to address the waning DTaP immunity now seen. “One option presented [at an international meeting] was a live-attenuated pertussis vaccine administered intranasally that would stimulate local immune responses and prevent colonization with pertussis organisms. This vaccine is currently being studied in adults and might provide a solution for waning immunity seen with DTaP vaccine,” she noted.
Another possibility is adding the live vaccine to the current DTaP, which should, in theory, stimulate more long-lasting immunity. But numerous safety studies in young children would be necessary before adopting such an approach, Dr. Edwards wrote.
Adding more antigens to the acellular vaccine also might work, and investigational vaccines like this are in development.
Studies in animals and humans show that acellular vaccines “generate functionally different T-cell responses than those seen after whole-cell vaccines, with the whole cell vaccines generating more protective T-cell responses. Studies are ongoing to determine if adjuvants can be added to acellular vaccines to modify their T-cell responses to a more protective immune response or whether the T-cell response remains fixed once primed with DTaP vaccine,” she wrote.
Dr. Edwards is a pediatric infectious disease specialist at Vanderbilt University, Nashville, Tenn. She wrote an editorial to accompany Zerbo et al (Pediatrics. 2019. doi: 10.1542/peds.2019-1276). She reported no financial disclosures, and received no funding to write the editorial.
Fixing one problem with the pertussis vaccine seemed to have created another, Kathryn M. Edwards, MD, wrote in an accompanying editorial.
The current acellular vaccine was approved in 1997. It was considered a less reactive substitute for the previous whole-cell vaccine, which was associated with injection site pain, swelling, fever, and febrile seizures, Dr. Edwards wrote. “For about a decade, all seemed to be going well with pertussis control. Serological methods were employed to diagnose pertussis infections in adolescents and adults, and polymerase chain reaction methods were devised to more accurately detect pertussis organisms. Thus, the burden of pertussis disease was increasingly appreciated as the diagnostic methods improved.”
But things soon changed. There were pertussis outbreaks, some of them quite large. The increasing disease rates showed that protection conferred by the acellular vaccine waned much more quickly than that conferred by the whole-cell vaccine. “In the current study, Zerbo et al. add to the body of evidence documenting the increase in pertussis risk with time after DTaP vaccination,” she noted.
This has several practical implications, Dr. Edwards wrote.
“First, given the markedly increased risk of pertussis in unvaccinated and undervaccinated children, universal DTaP vaccination should be strongly recommended. Second, the addition of maternal Tdap vaccination administered during pregnancy has been shown to significantly reduce infant disease before primary immunization and should remain the standard,” Dr. Edwards wrote.
More problematic is how to address the waning DTaP immunity now seen. “One option presented [at an international meeting] was a live-attenuated pertussis vaccine administered intranasally that would stimulate local immune responses and prevent colonization with pertussis organisms. This vaccine is currently being studied in adults and might provide a solution for waning immunity seen with DTaP vaccine,” she noted.
Another possibility is adding the live vaccine to the current DTaP, which should, in theory, stimulate more long-lasting immunity. But numerous safety studies in young children would be necessary before adopting such an approach, Dr. Edwards wrote.
Adding more antigens to the acellular vaccine also might work, and investigational vaccines like this are in development.
Studies in animals and humans show that acellular vaccines “generate functionally different T-cell responses than those seen after whole-cell vaccines, with the whole cell vaccines generating more protective T-cell responses. Studies are ongoing to determine if adjuvants can be added to acellular vaccines to modify their T-cell responses to a more protective immune response or whether the T-cell response remains fixed once primed with DTaP vaccine,” she wrote.
Dr. Edwards is a pediatric infectious disease specialist at Vanderbilt University, Nashville, Tenn. She wrote an editorial to accompany Zerbo et al (Pediatrics. 2019. doi: 10.1542/peds.2019-1276). She reported no financial disclosures, and received no funding to write the editorial.
Fixing one problem with the pertussis vaccine seemed to have created another, Kathryn M. Edwards, MD, wrote in an accompanying editorial.
The current acellular vaccine was approved in 1997. It was considered a less reactive substitute for the previous whole-cell vaccine, which was associated with injection site pain, swelling, fever, and febrile seizures, Dr. Edwards wrote. “For about a decade, all seemed to be going well with pertussis control. Serological methods were employed to diagnose pertussis infections in adolescents and adults, and polymerase chain reaction methods were devised to more accurately detect pertussis organisms. Thus, the burden of pertussis disease was increasingly appreciated as the diagnostic methods improved.”
But things soon changed. There were pertussis outbreaks, some of them quite large. The increasing disease rates showed that protection conferred by the acellular vaccine waned much more quickly than that conferred by the whole-cell vaccine. “In the current study, Zerbo et al. add to the body of evidence documenting the increase in pertussis risk with time after DTaP vaccination,” she noted.
This has several practical implications, Dr. Edwards wrote.
“First, given the markedly increased risk of pertussis in unvaccinated and undervaccinated children, universal DTaP vaccination should be strongly recommended. Second, the addition of maternal Tdap vaccination administered during pregnancy has been shown to significantly reduce infant disease before primary immunization and should remain the standard,” Dr. Edwards wrote.
More problematic is how to address the waning DTaP immunity now seen. “One option presented [at an international meeting] was a live-attenuated pertussis vaccine administered intranasally that would stimulate local immune responses and prevent colonization with pertussis organisms. This vaccine is currently being studied in adults and might provide a solution for waning immunity seen with DTaP vaccine,” she noted.
Another possibility is adding the live vaccine to the current DTaP, which should, in theory, stimulate more long-lasting immunity. But numerous safety studies in young children would be necessary before adopting such an approach, Dr. Edwards wrote.
Adding more antigens to the acellular vaccine also might work, and investigational vaccines like this are in development.
Studies in animals and humans show that acellular vaccines “generate functionally different T-cell responses than those seen after whole-cell vaccines, with the whole cell vaccines generating more protective T-cell responses. Studies are ongoing to determine if adjuvants can be added to acellular vaccines to modify their T-cell responses to a more protective immune response or whether the T-cell response remains fixed once primed with DTaP vaccine,” she wrote.
Dr. Edwards is a pediatric infectious disease specialist at Vanderbilt University, Nashville, Tenn. She wrote an editorial to accompany Zerbo et al (Pediatrics. 2019. doi: 10.1542/peds.2019-1276). She reported no financial disclosures, and received no funding to write the editorial.
A large Kaiser Permanente study paints a nuanced picture of the acellular pertussis vaccine, with more cases occurring in fully vaccinated children, but the highest risk of disease occurring among the under- and unvaccinated.
Among nearly half a million children, the unvaccinated were 13 times more likely to develop pertussis than fully vaccinated children, Ousseny Zerbo, PhD, of Kaiser Permanente Northern California in Oakland and colleagues wrote in Pediatrics. But 82% of cases occurred in fully vaccinated children and just 5% in undervaccinated children – and rates increased in both groups the farther they were in time from the last vaccination.
“Within our study population, greater than 80% of pertussis cases occurred among age-appropriately vaccinated children,” the team wrote. “Children who were further away from their last DTaP dose were at increased risk of pertussis, even after controlling for undervaccination. Our results suggest that, in this population, possibly in conjunction with other factors not addressed in this study, suboptimal vaccine efficacy and waning [immunity] played a major role in recent pertussis epidemics.”
The results are consistent with several prior studies, including one finding that the odds of the disease increased by 33% for every additional year after the third or fifth DTaP dose (Pediatrics. 2015;135[2]:331-43).
The current study comprised 469,982 children aged between 3 months and 11 years, who were followed for a mean of 4.6 years. Over the entire study period, there were 738 lab-confirmed pertussis cases. Most of these (515; 70%) occurred in fully vaccinated children. Another 99 (13%) occurred in unvaccinated children, 36 (5%) in undervaccinated children, and 88 (12%) in fully vaccinated plus one dose.
In a multivariate analysis, the risk of pertussis was 13 times higher among the unvaccinated (adjusted hazard ratio, 13) and almost 2 times higher among the undervaccinated (aHR, 1.9), compared with fully vaccinated children. Those who had been fully vaccinated and received a booster had the lowest risk, about half that of fully vaccinated children (aHR, 0.48).
Risk varied according to age, but also was significantly higher among unvaccinated children at each time point. Risk ranged from 4 times higher among those aged 3-5 months to 23 times higher among those aged 19-84 months. Undervaccinated children aged 5-7 months and 19-84 months also were at significantly increased risk for pertussis, compared with fully vaccinated children. Children who were fully vaccinated plus one dose had a significantly reduced risk at 7-19 months and at 19-84 months, compared with the fully vaccinated reference group.
“Across all follow-up and all age groups, VE [vaccine effectiveness] was 86% ... for undervaccinated children, compared with unvaccinated children,” Dr. Zerbo and associates wrote. “VE was even higher for fully vaccinated children [93%] and for those who were fully vaccinated plus one dose [96%].”
But VE waned as time progressed farther from the last DTaP dose. The multivariate model found more than a 100% increased risk for those whose last DTaP was at least 3 years past, compared with less than 1 year past (aHR, 2.58).
The model also found time-bound risk increases among fully vaccinated children, with a more than 300% increased risk among those at least 6 years out from the last DTaP dose, compared with 3 years out (aHR, 4.66).
The results indicate that other factors besides adherence to the recommended vaccine schedule may be at work in recent pertussis outbreaks.
“Although waning immunity is clearly an important factor driving pertussis epidemics in recent years, other factors that we did not evaluate in this study might also contribute to pertussis epidemics individually or in synergy,” Dr. Zerbo and associates wrote. “Results from studies in baboons suggest that the acellular pertussis vaccines are unable to prevent colonization, carriage, and transmission. If this is also true for humans, this could contribute to pertussis epidemics. The causes of recent pertussis epidemics are complex, and we were only able to address some aspects in our study.”
The study was funded by Kaiser Permanente Northern California, the National Institutes of Health, and in part by a National Institute of Allergy and Infectious Diseases grant. One coauthor reported receiving research grant support from Sanofi Pasteur, Novartis, GlaxoSmithKline, Merck, MedImmune, Pfizer, and Dynavax for unrelated studies; the other authors reported no relevant financial disclosures.
SOURCE: Zerbo O et al. Pediatrics. 2019 Jun 10. doi: 10.1542/peds.2018-3466.
A large Kaiser Permanente study paints a nuanced picture of the acellular pertussis vaccine, with more cases occurring in fully vaccinated children, but the highest risk of disease occurring among the under- and unvaccinated.
Among nearly half a million children, the unvaccinated were 13 times more likely to develop pertussis than fully vaccinated children, Ousseny Zerbo, PhD, of Kaiser Permanente Northern California in Oakland and colleagues wrote in Pediatrics. But 82% of cases occurred in fully vaccinated children and just 5% in undervaccinated children – and rates increased in both groups the farther they were in time from the last vaccination.
“Within our study population, greater than 80% of pertussis cases occurred among age-appropriately vaccinated children,” the team wrote. “Children who were further away from their last DTaP dose were at increased risk of pertussis, even after controlling for undervaccination. Our results suggest that, in this population, possibly in conjunction with other factors not addressed in this study, suboptimal vaccine efficacy and waning [immunity] played a major role in recent pertussis epidemics.”
The results are consistent with several prior studies, including one finding that the odds of the disease increased by 33% for every additional year after the third or fifth DTaP dose (Pediatrics. 2015;135[2]:331-43).
The current study comprised 469,982 children aged between 3 months and 11 years, who were followed for a mean of 4.6 years. Over the entire study period, there were 738 lab-confirmed pertussis cases. Most of these (515; 70%) occurred in fully vaccinated children. Another 99 (13%) occurred in unvaccinated children, 36 (5%) in undervaccinated children, and 88 (12%) in fully vaccinated plus one dose.
In a multivariate analysis, the risk of pertussis was 13 times higher among the unvaccinated (adjusted hazard ratio, 13) and almost 2 times higher among the undervaccinated (aHR, 1.9), compared with fully vaccinated children. Those who had been fully vaccinated and received a booster had the lowest risk, about half that of fully vaccinated children (aHR, 0.48).
Risk varied according to age, but also was significantly higher among unvaccinated children at each time point. Risk ranged from 4 times higher among those aged 3-5 months to 23 times higher among those aged 19-84 months. Undervaccinated children aged 5-7 months and 19-84 months also were at significantly increased risk for pertussis, compared with fully vaccinated children. Children who were fully vaccinated plus one dose had a significantly reduced risk at 7-19 months and at 19-84 months, compared with the fully vaccinated reference group.
“Across all follow-up and all age groups, VE [vaccine effectiveness] was 86% ... for undervaccinated children, compared with unvaccinated children,” Dr. Zerbo and associates wrote. “VE was even higher for fully vaccinated children [93%] and for those who were fully vaccinated plus one dose [96%].”
But VE waned as time progressed farther from the last DTaP dose. The multivariate model found more than a 100% increased risk for those whose last DTaP was at least 3 years past, compared with less than 1 year past (aHR, 2.58).
The model also found time-bound risk increases among fully vaccinated children, with a more than 300% increased risk among those at least 6 years out from the last DTaP dose, compared with 3 years out (aHR, 4.66).
The results indicate that other factors besides adherence to the recommended vaccine schedule may be at work in recent pertussis outbreaks.
“Although waning immunity is clearly an important factor driving pertussis epidemics in recent years, other factors that we did not evaluate in this study might also contribute to pertussis epidemics individually or in synergy,” Dr. Zerbo and associates wrote. “Results from studies in baboons suggest that the acellular pertussis vaccines are unable to prevent colonization, carriage, and transmission. If this is also true for humans, this could contribute to pertussis epidemics. The causes of recent pertussis epidemics are complex, and we were only able to address some aspects in our study.”
The study was funded by Kaiser Permanente Northern California, the National Institutes of Health, and in part by a National Institute of Allergy and Infectious Diseases grant. One coauthor reported receiving research grant support from Sanofi Pasteur, Novartis, GlaxoSmithKline, Merck, MedImmune, Pfizer, and Dynavax for unrelated studies; the other authors reported no relevant financial disclosures.
SOURCE: Zerbo O et al. Pediatrics. 2019 Jun 10. doi: 10.1542/peds.2018-3466.
FROM PEDIATRICS
United States now over 1,000 measles cases this year
The 41 new cases reported for the week ending June 6 bring the total for the year to 1,022, the CDC reported June 10, and that is more than any year since 1992, when there were 2,237 cases.
Idaho and Virginia reported their first cases of 2019, which makes a total of 28 states with measles cases this year. The Idaho case was reported in Latah County and is the state’s first since 2001. In Virginia, health officials are investigating possible contacts with an infected individual at Dulles International Airport and two other locations on June 2 and 4.
Outbreaks in Georgia, Maryland, and Michigan have ended, while seven others continue in California (Butte, Los Angeles, and Sacramento Counties), New York (Rockland County and New York City), Pennsylvania, and Washington, the CDC said. New York City has the largest outbreak this year with 509 cases through June 3, most of them occurring in Brooklyn.
The 41 new cases reported for the week ending June 6 bring the total for the year to 1,022, the CDC reported June 10, and that is more than any year since 1992, when there were 2,237 cases.
Idaho and Virginia reported their first cases of 2019, which makes a total of 28 states with measles cases this year. The Idaho case was reported in Latah County and is the state’s first since 2001. In Virginia, health officials are investigating possible contacts with an infected individual at Dulles International Airport and two other locations on June 2 and 4.
Outbreaks in Georgia, Maryland, and Michigan have ended, while seven others continue in California (Butte, Los Angeles, and Sacramento Counties), New York (Rockland County and New York City), Pennsylvania, and Washington, the CDC said. New York City has the largest outbreak this year with 509 cases through June 3, most of them occurring in Brooklyn.
The 41 new cases reported for the week ending June 6 bring the total for the year to 1,022, the CDC reported June 10, and that is more than any year since 1992, when there were 2,237 cases.
Idaho and Virginia reported their first cases of 2019, which makes a total of 28 states with measles cases this year. The Idaho case was reported in Latah County and is the state’s first since 2001. In Virginia, health officials are investigating possible contacts with an infected individual at Dulles International Airport and two other locations on June 2 and 4.
Outbreaks in Georgia, Maryland, and Michigan have ended, while seven others continue in California (Butte, Los Angeles, and Sacramento Counties), New York (Rockland County and New York City), Pennsylvania, and Washington, the CDC said. New York City has the largest outbreak this year with 509 cases through June 3, most of them occurring in Brooklyn.
VA Rolls Out New and Improved Veterans Community Care Program
Calling it a landmark initiative, the US Department of Veterans Affairs (VA) has launched its “new and improved” Veterans Community Care Program, implementing portions of the Maintaining Internal Systems and Strengthening Integrated Outside Networks Act of 2018 (MISSION Act). The initiative both ends the Veterans Choice Program, which expired June 6, and establishes a new Veterans Community Care Program. Senior VA leaders will visit > 30 VA hospitals across the country to support the rollout.
The MISSION Act is intended to provide veterans with more health care options. It also strengthens the VA’s ability to recruit and retain clinicians, authorizes “Anywhere to Anywhere” telehealth across state lines, gives veterans better access to community care, and establishes a new urgent care benefit.
“The changes not only improve our ability to provide the health care veterans need, but also when and where they need it,” said VA Secretary Robert Wilkie. “It will also put veterans at the center of their care and offer options, including expanded telehealth and urgent care, so they can find the balance in the system that is right for them.”
Eligibility for community care does not require veterans to receive that care in the community; they can still choose to have VA care. A veteran may elect to receive care in the community if he or she:
- needs a service not available at any VA medical facility;
- lives in a US state or territory without a full-service VA medical facility (applies to veterans living in Alaska, Hawaii, New Hampshire, Guam, American Samoa, the Northern Mariana Islands and the US Virgin Islands);
- qualifies under the “grandfather” provision related to distance eligibility under the Veterans Choice Program; and/or
- meets specific access standards for average drive time or appointment wait times.
The veteran also is eligible if he or she and the referring clinician agree that it is in the best medical interest of the veteran to receive community care based on defined factors, or if the VA has determined that a VA medical service line is not providing care in a manner that complies with VA’s standards for quality based on specific conditions.
In addition to the new eligibility rules, the VA says it has made a variety of improvements that will “make community care work better for veterans.”
One is that existing programs will be combined into a single community care program, to reduce complexity and the “likelihood of errors and problems.” The VA also is streamlining internal processes and modernizing IT systems, aiming to “speed up all aspects of community care—eligibility, authorizations, appointments, care coordination, claims, payments—while improving overall communication between veterans, community providers, and VA staff members.”
The VA has announced, as well, that 2 final regulations of the Veterans Community Care Program have been published in the Federal Register. One concerns the new urgent care benefit that provides eligible veterans with greater choice and access to timely, high-quality care for minor injuries and illnesses. The second regulation governs how eligible veterans receive necessary hospital care, medical services, and extended-care services from non-VA entities or providers in the community.
The VA will purchase most community care for veterans through its contracted network with third-party administrators (currently TriWest Healthcare Alliance and Optum Public). When the new Community Care Network of community providers is implemented, VA staff will work directly with veterans to schedule appointments and support care coordination.
A complete rollout of all 6 regions of the Community Care Network is expected by 2020. More detailed information is available at www.missionact.va.gov.
Calling it a landmark initiative, the US Department of Veterans Affairs (VA) has launched its “new and improved” Veterans Community Care Program, implementing portions of the Maintaining Internal Systems and Strengthening Integrated Outside Networks Act of 2018 (MISSION Act). The initiative both ends the Veterans Choice Program, which expired June 6, and establishes a new Veterans Community Care Program. Senior VA leaders will visit > 30 VA hospitals across the country to support the rollout.
The MISSION Act is intended to provide veterans with more health care options. It also strengthens the VA’s ability to recruit and retain clinicians, authorizes “Anywhere to Anywhere” telehealth across state lines, gives veterans better access to community care, and establishes a new urgent care benefit.
“The changes not only improve our ability to provide the health care veterans need, but also when and where they need it,” said VA Secretary Robert Wilkie. “It will also put veterans at the center of their care and offer options, including expanded telehealth and urgent care, so they can find the balance in the system that is right for them.”
Eligibility for community care does not require veterans to receive that care in the community; they can still choose to have VA care. A veteran may elect to receive care in the community if he or she:
- needs a service not available at any VA medical facility;
- lives in a US state or territory without a full-service VA medical facility (applies to veterans living in Alaska, Hawaii, New Hampshire, Guam, American Samoa, the Northern Mariana Islands and the US Virgin Islands);
- qualifies under the “grandfather” provision related to distance eligibility under the Veterans Choice Program; and/or
- meets specific access standards for average drive time or appointment wait times.
The veteran also is eligible if he or she and the referring clinician agree that it is in the best medical interest of the veteran to receive community care based on defined factors, or if the VA has determined that a VA medical service line is not providing care in a manner that complies with VA’s standards for quality based on specific conditions.
In addition to the new eligibility rules, the VA says it has made a variety of improvements that will “make community care work better for veterans.”
One is that existing programs will be combined into a single community care program, to reduce complexity and the “likelihood of errors and problems.” The VA also is streamlining internal processes and modernizing IT systems, aiming to “speed up all aspects of community care—eligibility, authorizations, appointments, care coordination, claims, payments—while improving overall communication between veterans, community providers, and VA staff members.”
The VA has announced, as well, that 2 final regulations of the Veterans Community Care Program have been published in the Federal Register. One concerns the new urgent care benefit that provides eligible veterans with greater choice and access to timely, high-quality care for minor injuries and illnesses. The second regulation governs how eligible veterans receive necessary hospital care, medical services, and extended-care services from non-VA entities or providers in the community.
The VA will purchase most community care for veterans through its contracted network with third-party administrators (currently TriWest Healthcare Alliance and Optum Public). When the new Community Care Network of community providers is implemented, VA staff will work directly with veterans to schedule appointments and support care coordination.
A complete rollout of all 6 regions of the Community Care Network is expected by 2020. More detailed information is available at www.missionact.va.gov.
Calling it a landmark initiative, the US Department of Veterans Affairs (VA) has launched its “new and improved” Veterans Community Care Program, implementing portions of the Maintaining Internal Systems and Strengthening Integrated Outside Networks Act of 2018 (MISSION Act). The initiative both ends the Veterans Choice Program, which expired June 6, and establishes a new Veterans Community Care Program. Senior VA leaders will visit > 30 VA hospitals across the country to support the rollout.
The MISSION Act is intended to provide veterans with more health care options. It also strengthens the VA’s ability to recruit and retain clinicians, authorizes “Anywhere to Anywhere” telehealth across state lines, gives veterans better access to community care, and establishes a new urgent care benefit.
“The changes not only improve our ability to provide the health care veterans need, but also when and where they need it,” said VA Secretary Robert Wilkie. “It will also put veterans at the center of their care and offer options, including expanded telehealth and urgent care, so they can find the balance in the system that is right for them.”
Eligibility for community care does not require veterans to receive that care in the community; they can still choose to have VA care. A veteran may elect to receive care in the community if he or she:
- needs a service not available at any VA medical facility;
- lives in a US state or territory without a full-service VA medical facility (applies to veterans living in Alaska, Hawaii, New Hampshire, Guam, American Samoa, the Northern Mariana Islands and the US Virgin Islands);
- qualifies under the “grandfather” provision related to distance eligibility under the Veterans Choice Program; and/or
- meets specific access standards for average drive time or appointment wait times.
The veteran also is eligible if he or she and the referring clinician agree that it is in the best medical interest of the veteran to receive community care based on defined factors, or if the VA has determined that a VA medical service line is not providing care in a manner that complies with VA’s standards for quality based on specific conditions.
In addition to the new eligibility rules, the VA says it has made a variety of improvements that will “make community care work better for veterans.”
One is that existing programs will be combined into a single community care program, to reduce complexity and the “likelihood of errors and problems.” The VA also is streamlining internal processes and modernizing IT systems, aiming to “speed up all aspects of community care—eligibility, authorizations, appointments, care coordination, claims, payments—while improving overall communication between veterans, community providers, and VA staff members.”
The VA has announced, as well, that 2 final regulations of the Veterans Community Care Program have been published in the Federal Register. One concerns the new urgent care benefit that provides eligible veterans with greater choice and access to timely, high-quality care for minor injuries and illnesses. The second regulation governs how eligible veterans receive necessary hospital care, medical services, and extended-care services from non-VA entities or providers in the community.
The VA will purchase most community care for veterans through its contracted network with third-party administrators (currently TriWest Healthcare Alliance and Optum Public). When the new Community Care Network of community providers is implemented, VA staff will work directly with veterans to schedule appointments and support care coordination.
A complete rollout of all 6 regions of the Community Care Network is expected by 2020. More detailed information is available at www.missionact.va.gov.
Tailored intervention improves asthma self-management for older patients
A needs- and barriers-based intervention that addressed psychosocial, physical, cognitive, and environmental barriers to self-management of asthma for older adults was successful in improving asthma outcomes and management, a recent trial has shown.
“This study demonstrates the value of patient centeredness and care coaching in supporting older adults with asthma and for ongoing efforts to engage patients in care delivery design and personalization,” Alex D. Federman, MD, of the division of general internal medicine at Icahn School of Medicine at Mount Sinai, New York, and colleagues wrote in their study, which was published in JAMA Internal Medicine. “It also highlights the challenges of engaging vulnerable populations in self-management support, including modest retention rates and reduced impact over time despite repeated encounters designed to sustain its effects.”
The researchers said older adults often have difficulty with self-management tasks like inhaler technique and use of inhaled corticosteroids, which can be caused by various psychosocial, physical, cognitive, or environmental barriers. However, an attempt at creating self-management tools around specific problems, rather than generalized training, has not been traditionally attempted, they noted.
For the SAMBA trial, Dr. Federman and colleagues enrolled 391 patients who were randomized to receive a home-based intervention, clinic-based intervention, or usual care, where an asthma care coach would identify the barriers to asthma control, train the patient in areas of improvement, and provide reinforcement when necessary. Patients were at least age 60 years (15.1% men) with uncontrolled asthma in New York City and were enrolled between February 2014 and December 2017. Researchers used the Mini Asthma Quality of Life Questionnaire, Asthma Control Test, metered dose inhaler technique, Medication Adherence Rating Scale, and visits to the emergency room to assess outcomes between interventions and usual care, and between home and clinic care. The data was analyzed using the ‘difference in differences’ statistical technique to compare the change differential between the groups.
They found significantly better asthma control scores between the intervention group and the control groups at 3 months (difference-in-differences, 1.2; 95% confidence interval, 0.2-2.2; P = .02), 6 months (D-in-Ds, 1.0; 95% CI, 0.0-2.1; P = .049), and 12 months (D-inDs, 0.6; 95% CI, −0.5 to 1.8; P = .28). Quality of life was significantly improved in the intervention group, compared with control patients (overall effect, chi-squared = 10.5; with 4 degrees of freedom; P = .01), as was adherence to medication (overall effect, chi-squared = 9.5, with 4 degrees of freedom; P = .049), and inhaler technique as measured by correctly completed steps at 12 months (75% vs. 58%). Visits to the emergency room were also lower in the intervention group, compared with the control group (6.2% vs. 12.7%; adjusted odds ratio, 0.8; 95% CI, 0.6-0.99; both P = .03). The researchers noted there were no significant differences between home care and clinic care.
Potential limitations in the study included a lower-than-planned statistical power, 70% retention in the intervention arms, low generalizability of the findings, and lack of blinding on the part of research assistants as well as some improvement in asthma control and outcomes in the control group.
This study was funded in part by the Patient-Centered Outcomes Research Institute. Coauthors Nandini Shroff reported grants from the Patient-Centered Outcomes Research Institute; Michael S. Wolf reported grants from Eli Lilly; and Juan P. Wisnivesky reported personal fees from Sanofi, Quintiles, and Banook, and grants from Sanofi and Quorum. The other authors reported no relevant conflicts of interest.
SOURCE: Federman AD et al. JAMA Intern Med. 2019; doi: 10.1001/jamainternmed.2019.1201.
A needs- and barriers-based intervention that addressed psychosocial, physical, cognitive, and environmental barriers to self-management of asthma for older adults was successful in improving asthma outcomes and management, a recent trial has shown.
“This study demonstrates the value of patient centeredness and care coaching in supporting older adults with asthma and for ongoing efforts to engage patients in care delivery design and personalization,” Alex D. Federman, MD, of the division of general internal medicine at Icahn School of Medicine at Mount Sinai, New York, and colleagues wrote in their study, which was published in JAMA Internal Medicine. “It also highlights the challenges of engaging vulnerable populations in self-management support, including modest retention rates and reduced impact over time despite repeated encounters designed to sustain its effects.”
The researchers said older adults often have difficulty with self-management tasks like inhaler technique and use of inhaled corticosteroids, which can be caused by various psychosocial, physical, cognitive, or environmental barriers. However, an attempt at creating self-management tools around specific problems, rather than generalized training, has not been traditionally attempted, they noted.
For the SAMBA trial, Dr. Federman and colleagues enrolled 391 patients who were randomized to receive a home-based intervention, clinic-based intervention, or usual care, where an asthma care coach would identify the barriers to asthma control, train the patient in areas of improvement, and provide reinforcement when necessary. Patients were at least age 60 years (15.1% men) with uncontrolled asthma in New York City and were enrolled between February 2014 and December 2017. Researchers used the Mini Asthma Quality of Life Questionnaire, Asthma Control Test, metered dose inhaler technique, Medication Adherence Rating Scale, and visits to the emergency room to assess outcomes between interventions and usual care, and between home and clinic care. The data was analyzed using the ‘difference in differences’ statistical technique to compare the change differential between the groups.
They found significantly better asthma control scores between the intervention group and the control groups at 3 months (difference-in-differences, 1.2; 95% confidence interval, 0.2-2.2; P = .02), 6 months (D-in-Ds, 1.0; 95% CI, 0.0-2.1; P = .049), and 12 months (D-inDs, 0.6; 95% CI, −0.5 to 1.8; P = .28). Quality of life was significantly improved in the intervention group, compared with control patients (overall effect, chi-squared = 10.5; with 4 degrees of freedom; P = .01), as was adherence to medication (overall effect, chi-squared = 9.5, with 4 degrees of freedom; P = .049), and inhaler technique as measured by correctly completed steps at 12 months (75% vs. 58%). Visits to the emergency room were also lower in the intervention group, compared with the control group (6.2% vs. 12.7%; adjusted odds ratio, 0.8; 95% CI, 0.6-0.99; both P = .03). The researchers noted there were no significant differences between home care and clinic care.
Potential limitations in the study included a lower-than-planned statistical power, 70% retention in the intervention arms, low generalizability of the findings, and lack of blinding on the part of research assistants as well as some improvement in asthma control and outcomes in the control group.
This study was funded in part by the Patient-Centered Outcomes Research Institute. Coauthors Nandini Shroff reported grants from the Patient-Centered Outcomes Research Institute; Michael S. Wolf reported grants from Eli Lilly; and Juan P. Wisnivesky reported personal fees from Sanofi, Quintiles, and Banook, and grants from Sanofi and Quorum. The other authors reported no relevant conflicts of interest.
SOURCE: Federman AD et al. JAMA Intern Med. 2019; doi: 10.1001/jamainternmed.2019.1201.
A needs- and barriers-based intervention that addressed psychosocial, physical, cognitive, and environmental barriers to self-management of asthma for older adults was successful in improving asthma outcomes and management, a recent trial has shown.
“This study demonstrates the value of patient centeredness and care coaching in supporting older adults with asthma and for ongoing efforts to engage patients in care delivery design and personalization,” Alex D. Federman, MD, of the division of general internal medicine at Icahn School of Medicine at Mount Sinai, New York, and colleagues wrote in their study, which was published in JAMA Internal Medicine. “It also highlights the challenges of engaging vulnerable populations in self-management support, including modest retention rates and reduced impact over time despite repeated encounters designed to sustain its effects.”
The researchers said older adults often have difficulty with self-management tasks like inhaler technique and use of inhaled corticosteroids, which can be caused by various psychosocial, physical, cognitive, or environmental barriers. However, an attempt at creating self-management tools around specific problems, rather than generalized training, has not been traditionally attempted, they noted.
For the SAMBA trial, Dr. Federman and colleagues enrolled 391 patients who were randomized to receive a home-based intervention, clinic-based intervention, or usual care, where an asthma care coach would identify the barriers to asthma control, train the patient in areas of improvement, and provide reinforcement when necessary. Patients were at least age 60 years (15.1% men) with uncontrolled asthma in New York City and were enrolled between February 2014 and December 2017. Researchers used the Mini Asthma Quality of Life Questionnaire, Asthma Control Test, metered dose inhaler technique, Medication Adherence Rating Scale, and visits to the emergency room to assess outcomes between interventions and usual care, and between home and clinic care. The data was analyzed using the ‘difference in differences’ statistical technique to compare the change differential between the groups.
They found significantly better asthma control scores between the intervention group and the control groups at 3 months (difference-in-differences, 1.2; 95% confidence interval, 0.2-2.2; P = .02), 6 months (D-in-Ds, 1.0; 95% CI, 0.0-2.1; P = .049), and 12 months (D-inDs, 0.6; 95% CI, −0.5 to 1.8; P = .28). Quality of life was significantly improved in the intervention group, compared with control patients (overall effect, chi-squared = 10.5; with 4 degrees of freedom; P = .01), as was adherence to medication (overall effect, chi-squared = 9.5, with 4 degrees of freedom; P = .049), and inhaler technique as measured by correctly completed steps at 12 months (75% vs. 58%). Visits to the emergency room were also lower in the intervention group, compared with the control group (6.2% vs. 12.7%; adjusted odds ratio, 0.8; 95% CI, 0.6-0.99; both P = .03). The researchers noted there were no significant differences between home care and clinic care.
Potential limitations in the study included a lower-than-planned statistical power, 70% retention in the intervention arms, low generalizability of the findings, and lack of blinding on the part of research assistants as well as some improvement in asthma control and outcomes in the control group.
This study was funded in part by the Patient-Centered Outcomes Research Institute. Coauthors Nandini Shroff reported grants from the Patient-Centered Outcomes Research Institute; Michael S. Wolf reported grants from Eli Lilly; and Juan P. Wisnivesky reported personal fees from Sanofi, Quintiles, and Banook, and grants from Sanofi and Quorum. The other authors reported no relevant conflicts of interest.
SOURCE: Federman AD et al. JAMA Intern Med. 2019; doi: 10.1001/jamainternmed.2019.1201.
FROM JAMA INTERNAL MEDICINE
FDA approves Nucala’s new at-home formulations
, according to a press release from the drug’s developer. The biologic will now be available as an autoinjector and as a prefilled safety syringe.
The 100-mg subcutaneous mepolizumab injection is indicated as an add-on treatment for patients 12 years and older with severe eosinophilic asthma, and the three-dose 100-mg subcutaneous injections are indicated for the rare eosinophilic granulomatosis and polyangiitis, with the biologic administered every 4 weeks in either context. The release emphasizes that mepolizumab is not approved for acute bronchospasm or status asthmaticus. Health care professionals should first determine whether self-assisted administration or administration provided by a caregiver is appropriate, and then they should provide patients and/or caregivers with proper training in how to do so.
The approval is based on two open-label, single-arm, phase 3a studies that demonstrated successful administration was possible with these options among patients with severe eosinophilic asthma, at rates of 89%-95% in one study and 100% in the other. These results were followed by those of an open-label, parallel group, single-dose study that confirmed the pharmacokinetic and pharmacodynamic profiles of these new means of administration were comparable with those currently approved.
Mepolizumab is not indicated for those with a history of hypersensitivity to either mepolizumab or to the formulation’s excipients, such as anaphylaxis, angioedema, bronchospasm, hypotension, urticaria, or rash. Any reductions of inhaled corticosteroids after initiation of mepolizumab should be gradual and under the supervision of a health care professional. Some infections by herpes zoster have been observed. The most common adverse reactions (occurring in 3% or more of patients and more often than with placebo) during the first 24 weeks of treatment were headache (19%), injection site reaction (8%), back pain (5%), fatigue (5%), influenza (3%), urinary tract infection (3%), abdominal pain upper (3%), pruritus (3%), eczema (3%), and muscle spasm (3%). Full prescribing information can be found on the FDA website.
, according to a press release from the drug’s developer. The biologic will now be available as an autoinjector and as a prefilled safety syringe.
The 100-mg subcutaneous mepolizumab injection is indicated as an add-on treatment for patients 12 years and older with severe eosinophilic asthma, and the three-dose 100-mg subcutaneous injections are indicated for the rare eosinophilic granulomatosis and polyangiitis, with the biologic administered every 4 weeks in either context. The release emphasizes that mepolizumab is not approved for acute bronchospasm or status asthmaticus. Health care professionals should first determine whether self-assisted administration or administration provided by a caregiver is appropriate, and then they should provide patients and/or caregivers with proper training in how to do so.
The approval is based on two open-label, single-arm, phase 3a studies that demonstrated successful administration was possible with these options among patients with severe eosinophilic asthma, at rates of 89%-95% in one study and 100% in the other. These results were followed by those of an open-label, parallel group, single-dose study that confirmed the pharmacokinetic and pharmacodynamic profiles of these new means of administration were comparable with those currently approved.
Mepolizumab is not indicated for those with a history of hypersensitivity to either mepolizumab or to the formulation’s excipients, such as anaphylaxis, angioedema, bronchospasm, hypotension, urticaria, or rash. Any reductions of inhaled corticosteroids after initiation of mepolizumab should be gradual and under the supervision of a health care professional. Some infections by herpes zoster have been observed. The most common adverse reactions (occurring in 3% or more of patients and more often than with placebo) during the first 24 weeks of treatment were headache (19%), injection site reaction (8%), back pain (5%), fatigue (5%), influenza (3%), urinary tract infection (3%), abdominal pain upper (3%), pruritus (3%), eczema (3%), and muscle spasm (3%). Full prescribing information can be found on the FDA website.
, according to a press release from the drug’s developer. The biologic will now be available as an autoinjector and as a prefilled safety syringe.
The 100-mg subcutaneous mepolizumab injection is indicated as an add-on treatment for patients 12 years and older with severe eosinophilic asthma, and the three-dose 100-mg subcutaneous injections are indicated for the rare eosinophilic granulomatosis and polyangiitis, with the biologic administered every 4 weeks in either context. The release emphasizes that mepolizumab is not approved for acute bronchospasm or status asthmaticus. Health care professionals should first determine whether self-assisted administration or administration provided by a caregiver is appropriate, and then they should provide patients and/or caregivers with proper training in how to do so.
The approval is based on two open-label, single-arm, phase 3a studies that demonstrated successful administration was possible with these options among patients with severe eosinophilic asthma, at rates of 89%-95% in one study and 100% in the other. These results were followed by those of an open-label, parallel group, single-dose study that confirmed the pharmacokinetic and pharmacodynamic profiles of these new means of administration were comparable with those currently approved.
Mepolizumab is not indicated for those with a history of hypersensitivity to either mepolizumab or to the formulation’s excipients, such as anaphylaxis, angioedema, bronchospasm, hypotension, urticaria, or rash. Any reductions of inhaled corticosteroids after initiation of mepolizumab should be gradual and under the supervision of a health care professional. Some infections by herpes zoster have been observed. The most common adverse reactions (occurring in 3% or more of patients and more often than with placebo) during the first 24 weeks of treatment were headache (19%), injection site reaction (8%), back pain (5%), fatigue (5%), influenza (3%), urinary tract infection (3%), abdominal pain upper (3%), pruritus (3%), eczema (3%), and muscle spasm (3%). Full prescribing information can be found on the FDA website.
CDC Updates Cancer Cluster Guidelines
In 2013, the CDC published guidelines to help state, tribal, local, and territorial public health agencies apply a systematic approach when responding to inquiries about suspected cancer clusters.
But since then, the CDC says, there have been technical and scientific advances that may be useful—so it is time to update Investigating Suspected Cancer Clusters and Responding to Community Concerns: Guidelines from CDC and the Council of State and Territorial Epidemiologists.
The CDC is working with the Agency for Toxic Substances and Disease Registry (ATSDR) to update the 2013 guidelines to ensure that users have access to current scientific tools and approaches. The new version will include input from subject matter experts, public health agencies, the public, and other stakeholders.
“We don’t yet know how the guidelines will change,” the CDC says. Once they are written, though, the public will have the opportunity to comment. In the meantime, the public and interested organizations are invited to participate by submitting written views, information, recommendations, and data. The CDC and ATSDR are looking for answers to questions such as, “What are the best approaches to respond to community concerns about potential cancer clusters?” and “What gaps and challenges exist in the 2013 guidelines? What are possible solutions to overcoming them?” Comments will be posted on https://www.regulations.gov.
The request for comment was posted May 15 in the Federal Register and will be available for public comment through July 15, 2019. For more information and to provide comment, visit https://www.federalregister.gov/documents/2019/05/15/2019-09998/updating-federal-guidelines-used-by-public-health-agencies-to-assess-and-respond-to-potential-cancer.
In 2013, the CDC published guidelines to help state, tribal, local, and territorial public health agencies apply a systematic approach when responding to inquiries about suspected cancer clusters.
But since then, the CDC says, there have been technical and scientific advances that may be useful—so it is time to update Investigating Suspected Cancer Clusters and Responding to Community Concerns: Guidelines from CDC and the Council of State and Territorial Epidemiologists.
The CDC is working with the Agency for Toxic Substances and Disease Registry (ATSDR) to update the 2013 guidelines to ensure that users have access to current scientific tools and approaches. The new version will include input from subject matter experts, public health agencies, the public, and other stakeholders.
“We don’t yet know how the guidelines will change,” the CDC says. Once they are written, though, the public will have the opportunity to comment. In the meantime, the public and interested organizations are invited to participate by submitting written views, information, recommendations, and data. The CDC and ATSDR are looking for answers to questions such as, “What are the best approaches to respond to community concerns about potential cancer clusters?” and “What gaps and challenges exist in the 2013 guidelines? What are possible solutions to overcoming them?” Comments will be posted on https://www.regulations.gov.
The request for comment was posted May 15 in the Federal Register and will be available for public comment through July 15, 2019. For more information and to provide comment, visit https://www.federalregister.gov/documents/2019/05/15/2019-09998/updating-federal-guidelines-used-by-public-health-agencies-to-assess-and-respond-to-potential-cancer.
In 2013, the CDC published guidelines to help state, tribal, local, and territorial public health agencies apply a systematic approach when responding to inquiries about suspected cancer clusters.
But since then, the CDC says, there have been technical and scientific advances that may be useful—so it is time to update Investigating Suspected Cancer Clusters and Responding to Community Concerns: Guidelines from CDC and the Council of State and Territorial Epidemiologists.
The CDC is working with the Agency for Toxic Substances and Disease Registry (ATSDR) to update the 2013 guidelines to ensure that users have access to current scientific tools and approaches. The new version will include input from subject matter experts, public health agencies, the public, and other stakeholders.
“We don’t yet know how the guidelines will change,” the CDC says. Once they are written, though, the public will have the opportunity to comment. In the meantime, the public and interested organizations are invited to participate by submitting written views, information, recommendations, and data. The CDC and ATSDR are looking for answers to questions such as, “What are the best approaches to respond to community concerns about potential cancer clusters?” and “What gaps and challenges exist in the 2013 guidelines? What are possible solutions to overcoming them?” Comments will be posted on https://www.regulations.gov.
The request for comment was posted May 15 in the Federal Register and will be available for public comment through July 15, 2019. For more information and to provide comment, visit https://www.federalregister.gov/documents/2019/05/15/2019-09998/updating-federal-guidelines-used-by-public-health-agencies-to-assess-and-respond-to-potential-cancer.
Pediatricians report low knowledge, comfort discussing e-cigarettes
BALTIMORE – according to a recent study.
“Providers are aware of the increased prevalence, harms [of e-cigs] and [the] positive impact of counseling teens about e-cigs,” said Allison Heinly, MD, of Hasbro Children’s Hospital in Providence, R.I., and her colleagues. But, “providers are less likely to ask, advise, or assist parents [and teens] regarding e-cig use, compared to tobacco, and are less comfortable doing so.” The researchers presented their findings at the Pediatric Academic Societies annual meeting.
A variety of concerns exist regarding ingredients in e-cigarettes, Dr. Heinly noted, including nicotine, volatile organic compounds, carcinogenic chemicals, flavorings, and ultra-fine particles.
Dr. Heinly and her associates aimed to assess pediatricians’ knowledge, attitudes, and behaviors toward both teens’ and parents’ use of e-cigarettes, as well as the barrier pediatricians perceived when it came to screening and counseling those who use e-cigarettes.
Among 69 providers at a large Northeastern urban academic primary care clinic who received surveys, 62 responded, primarily residents (84%). The respondents included 44 pediatric residents, eight triple-board residents, and 10 attending physicians.
The researchers collapsed “most of the time”/“always” and “some of the time”/“never” responses into two categories.
Most of the respondents (82%) knew e-cigarettes are the most common tobacco product that youth use, and nearly all (97%) believed e-cigarettes were addictive and harmful to users’ health. In addition, most (79%) believed using e-cigarettes could be a pathway toward students beginning to use other drugs.
Even though respondents believed counseling teens about use of tobacco or e-cigarettes can reduce the likelihood that they will start using them, providers were much less likely to discuss e-cigarettes than tobacco with teens.
Nearly all the doctors (97%) reported asking teens about their use of tobacco, but only about half (52%) asked about e-cigarette use (P less than .001). And only about one in five doctors (21%) reported counseling teens about using e-cigarettes, compared with 47% of those who advised teens regarding tobacco use (P = .002).
Over a third of responding physicians (37%) reported helping adolescent patients quit using tobacco, but just 7% reported doing so with e-cigarettes (P less than .001).
Doctors overwhelmingly reported feeling comfortable talking about tobacco with teens (98%), but fewer felt comfortable discussing e-cigarettes (77%; P less than .001). Respondents similarly were less comfortable discussing e-cigarettes (55%) than tobacco (87%) with parents (P less than .001).
Very few pediatricians asked parents about their use of e-cigarettes (5%) or advised them about e-cigarettes’ harms (7%), and even fewer reported helping parents quit using them (2%). By contrast, more than half of pediatricians (60%) asked parents about smoking or advised them about tobacco use harms (52%), and nearly one-third (31%) reported helping parents quit smoking (P less than .001 for all comparisons).
The biggest barrier to discussing e-cigarettes with families was, as with discussing tobacco, not having enough time. But about twice as many respondents cited insufficient knowledge as a barrier for e-cigarettes as for tobacco (P = .003). A small percentage of respondents (less than 20%) also reported feeling unsure about the harm of e-cigarettes (P = .001).
Lack of training was a significant barrier to physicians’ discussion of e-cigarettes as well. Many more physicians reported receiving training in medical school on tobacco and traditional cigarettes (78%) than on e-cigarettes (13%), possibly because of how recently e-cigarettes have become widely available (P less than .001).
More physicians reported receiving training related to e-cigarettes during residency (36%), but it still fell well short of how many reported other tobacco and smoking training during residency (61%; P = .001).
The findings “emphasize the importance of increasing training about e-cig counseling,” Dr. Heinly and her associates concluded.
The researchers noted no external funding or disclosures.
BALTIMORE – according to a recent study.
“Providers are aware of the increased prevalence, harms [of e-cigs] and [the] positive impact of counseling teens about e-cigs,” said Allison Heinly, MD, of Hasbro Children’s Hospital in Providence, R.I., and her colleagues. But, “providers are less likely to ask, advise, or assist parents [and teens] regarding e-cig use, compared to tobacco, and are less comfortable doing so.” The researchers presented their findings at the Pediatric Academic Societies annual meeting.
A variety of concerns exist regarding ingredients in e-cigarettes, Dr. Heinly noted, including nicotine, volatile organic compounds, carcinogenic chemicals, flavorings, and ultra-fine particles.
Dr. Heinly and her associates aimed to assess pediatricians’ knowledge, attitudes, and behaviors toward both teens’ and parents’ use of e-cigarettes, as well as the barrier pediatricians perceived when it came to screening and counseling those who use e-cigarettes.
Among 69 providers at a large Northeastern urban academic primary care clinic who received surveys, 62 responded, primarily residents (84%). The respondents included 44 pediatric residents, eight triple-board residents, and 10 attending physicians.
The researchers collapsed “most of the time”/“always” and “some of the time”/“never” responses into two categories.
Most of the respondents (82%) knew e-cigarettes are the most common tobacco product that youth use, and nearly all (97%) believed e-cigarettes were addictive and harmful to users’ health. In addition, most (79%) believed using e-cigarettes could be a pathway toward students beginning to use other drugs.
Even though respondents believed counseling teens about use of tobacco or e-cigarettes can reduce the likelihood that they will start using them, providers were much less likely to discuss e-cigarettes than tobacco with teens.
Nearly all the doctors (97%) reported asking teens about their use of tobacco, but only about half (52%) asked about e-cigarette use (P less than .001). And only about one in five doctors (21%) reported counseling teens about using e-cigarettes, compared with 47% of those who advised teens regarding tobacco use (P = .002).
Over a third of responding physicians (37%) reported helping adolescent patients quit using tobacco, but just 7% reported doing so with e-cigarettes (P less than .001).
Doctors overwhelmingly reported feeling comfortable talking about tobacco with teens (98%), but fewer felt comfortable discussing e-cigarettes (77%; P less than .001). Respondents similarly were less comfortable discussing e-cigarettes (55%) than tobacco (87%) with parents (P less than .001).
Very few pediatricians asked parents about their use of e-cigarettes (5%) or advised them about e-cigarettes’ harms (7%), and even fewer reported helping parents quit using them (2%). By contrast, more than half of pediatricians (60%) asked parents about smoking or advised them about tobacco use harms (52%), and nearly one-third (31%) reported helping parents quit smoking (P less than .001 for all comparisons).
The biggest barrier to discussing e-cigarettes with families was, as with discussing tobacco, not having enough time. But about twice as many respondents cited insufficient knowledge as a barrier for e-cigarettes as for tobacco (P = .003). A small percentage of respondents (less than 20%) also reported feeling unsure about the harm of e-cigarettes (P = .001).
Lack of training was a significant barrier to physicians’ discussion of e-cigarettes as well. Many more physicians reported receiving training in medical school on tobacco and traditional cigarettes (78%) than on e-cigarettes (13%), possibly because of how recently e-cigarettes have become widely available (P less than .001).
More physicians reported receiving training related to e-cigarettes during residency (36%), but it still fell well short of how many reported other tobacco and smoking training during residency (61%; P = .001).
The findings “emphasize the importance of increasing training about e-cig counseling,” Dr. Heinly and her associates concluded.
The researchers noted no external funding or disclosures.
BALTIMORE – according to a recent study.
“Providers are aware of the increased prevalence, harms [of e-cigs] and [the] positive impact of counseling teens about e-cigs,” said Allison Heinly, MD, of Hasbro Children’s Hospital in Providence, R.I., and her colleagues. But, “providers are less likely to ask, advise, or assist parents [and teens] regarding e-cig use, compared to tobacco, and are less comfortable doing so.” The researchers presented their findings at the Pediatric Academic Societies annual meeting.
A variety of concerns exist regarding ingredients in e-cigarettes, Dr. Heinly noted, including nicotine, volatile organic compounds, carcinogenic chemicals, flavorings, and ultra-fine particles.
Dr. Heinly and her associates aimed to assess pediatricians’ knowledge, attitudes, and behaviors toward both teens’ and parents’ use of e-cigarettes, as well as the barrier pediatricians perceived when it came to screening and counseling those who use e-cigarettes.
Among 69 providers at a large Northeastern urban academic primary care clinic who received surveys, 62 responded, primarily residents (84%). The respondents included 44 pediatric residents, eight triple-board residents, and 10 attending physicians.
The researchers collapsed “most of the time”/“always” and “some of the time”/“never” responses into two categories.
Most of the respondents (82%) knew e-cigarettes are the most common tobacco product that youth use, and nearly all (97%) believed e-cigarettes were addictive and harmful to users’ health. In addition, most (79%) believed using e-cigarettes could be a pathway toward students beginning to use other drugs.
Even though respondents believed counseling teens about use of tobacco or e-cigarettes can reduce the likelihood that they will start using them, providers were much less likely to discuss e-cigarettes than tobacco with teens.
Nearly all the doctors (97%) reported asking teens about their use of tobacco, but only about half (52%) asked about e-cigarette use (P less than .001). And only about one in five doctors (21%) reported counseling teens about using e-cigarettes, compared with 47% of those who advised teens regarding tobacco use (P = .002).
Over a third of responding physicians (37%) reported helping adolescent patients quit using tobacco, but just 7% reported doing so with e-cigarettes (P less than .001).
Doctors overwhelmingly reported feeling comfortable talking about tobacco with teens (98%), but fewer felt comfortable discussing e-cigarettes (77%; P less than .001). Respondents similarly were less comfortable discussing e-cigarettes (55%) than tobacco (87%) with parents (P less than .001).
Very few pediatricians asked parents about their use of e-cigarettes (5%) or advised them about e-cigarettes’ harms (7%), and even fewer reported helping parents quit using them (2%). By contrast, more than half of pediatricians (60%) asked parents about smoking or advised them about tobacco use harms (52%), and nearly one-third (31%) reported helping parents quit smoking (P less than .001 for all comparisons).
The biggest barrier to discussing e-cigarettes with families was, as with discussing tobacco, not having enough time. But about twice as many respondents cited insufficient knowledge as a barrier for e-cigarettes as for tobacco (P = .003). A small percentage of respondents (less than 20%) also reported feeling unsure about the harm of e-cigarettes (P = .001).
Lack of training was a significant barrier to physicians’ discussion of e-cigarettes as well. Many more physicians reported receiving training in medical school on tobacco and traditional cigarettes (78%) than on e-cigarettes (13%), possibly because of how recently e-cigarettes have become widely available (P less than .001).
More physicians reported receiving training related to e-cigarettes during residency (36%), but it still fell well short of how many reported other tobacco and smoking training during residency (61%; P = .001).
The findings “emphasize the importance of increasing training about e-cig counseling,” Dr. Heinly and her associates concluded.
The researchers noted no external funding or disclosures.
REPORTING FROM PAS 2019
Key clinical point: Physicians report less training and less comfort when discussing e-cigarettes with teens and parents than when discussing tobacco products.
Major finding: 7% of physicians reported helping adolescent patients quit using e-cigarettes, compared with 37% helping with quitting tobacco use (P less than .001).
Study details: The findings are based on a cross-sectional survey of 62 pediatric residents and attendings at a large urban academic primary care clinic in the Northeast.
Disclosures: The researchers noted no external funding or disclosures.
FDA approves new treatment for hospital-acquired, ventilator-associated bacterial pneumonia
authorizing it for the treatment of both hospital-acquired and ventilator-associated bacterial pneumonia.
The new indication is for patients 18 years and older. It was based on results of a multinational, double-blind study that compared Zerbaxa with a different antibacterial drug in 726 patients hospitalized with hospital-acquired/ventilator-associated bacterial pneumonia. Mortality and cure rates were similar in the Zerbaxa and comparator groups.
The most common adverse events observed in the trial were elevated liver enzyme levels, renal impairment or failure, and diarrhea. Patients with hypersensitivity to beta-lactam drugs should not be receive Zerbaxa.
“A key global challenge we face as a public health agency is addressing the threat of antimicrobial-resistant infections. Hospital-acquired and ventilator-associated bacterial pneumonia are serious infections that can result in death in some patients. ... That’s why, among our other efforts to address antimicrobial resistance, we’re focused on facilitating the development of safe and effective new treatments to give patients more options to fight life-threatening infections,” said Amy Abernethy, MD, PhD, the FDA’s principal deputy commissioner.
Zerbaxa was initially approved in 2014 for treatment of complicated intra-abdominal and urinary tract infections.
Find the full press release on the FDA website.
authorizing it for the treatment of both hospital-acquired and ventilator-associated bacterial pneumonia.
The new indication is for patients 18 years and older. It was based on results of a multinational, double-blind study that compared Zerbaxa with a different antibacterial drug in 726 patients hospitalized with hospital-acquired/ventilator-associated bacterial pneumonia. Mortality and cure rates were similar in the Zerbaxa and comparator groups.
The most common adverse events observed in the trial were elevated liver enzyme levels, renal impairment or failure, and diarrhea. Patients with hypersensitivity to beta-lactam drugs should not be receive Zerbaxa.
“A key global challenge we face as a public health agency is addressing the threat of antimicrobial-resistant infections. Hospital-acquired and ventilator-associated bacterial pneumonia are serious infections that can result in death in some patients. ... That’s why, among our other efforts to address antimicrobial resistance, we’re focused on facilitating the development of safe and effective new treatments to give patients more options to fight life-threatening infections,” said Amy Abernethy, MD, PhD, the FDA’s principal deputy commissioner.
Zerbaxa was initially approved in 2014 for treatment of complicated intra-abdominal and urinary tract infections.
Find the full press release on the FDA website.
authorizing it for the treatment of both hospital-acquired and ventilator-associated bacterial pneumonia.
The new indication is for patients 18 years and older. It was based on results of a multinational, double-blind study that compared Zerbaxa with a different antibacterial drug in 726 patients hospitalized with hospital-acquired/ventilator-associated bacterial pneumonia. Mortality and cure rates were similar in the Zerbaxa and comparator groups.
The most common adverse events observed in the trial were elevated liver enzyme levels, renal impairment or failure, and diarrhea. Patients with hypersensitivity to beta-lactam drugs should not be receive Zerbaxa.
“A key global challenge we face as a public health agency is addressing the threat of antimicrobial-resistant infections. Hospital-acquired and ventilator-associated bacterial pneumonia are serious infections that can result in death in some patients. ... That’s why, among our other efforts to address antimicrobial resistance, we’re focused on facilitating the development of safe and effective new treatments to give patients more options to fight life-threatening infections,” said Amy Abernethy, MD, PhD, the FDA’s principal deputy commissioner.
Zerbaxa was initially approved in 2014 for treatment of complicated intra-abdominal and urinary tract infections.
Find the full press release on the FDA website.
Lack of inhaler at school a major barrier to asthma care
BALTIMORE – frequently because the parent did not provide an inhaler or did not provide a written order for one, according to new research. Only seven U.S. states have laws allowing schools to stock albuterol for students.
“Most students only have access to this lifesaving medication when they bring a personal inhaler,” Alexandra M. Sims, MD, of Children’s National Hospital in Washington and colleagues wrote in their abstract at the annual meeting of Pediatric Academic Societies. “Interventions that address medication availability may be an important step in removing obstacles to asthma care in school.”
One such option is a stock inhaler available for any students to use. National guidelines from the Centers for Disease Control and Prevention recommend that students with asthma have access to inhaled albuterol at school, yet most states do not have legislation related to albuterol stocking in schools, according to the Asthma and Allergy Foundation of America.
Not having access to rescue inhaler medication at school contributes to lost class time and referrals to the emergency department, the authors note in their background information. Yet, “in most U.S. jurisdictions, including the school district we examined, students need both a personal albuterol inhaler and a physician order to receive medication at school.”
To determine what barriers exist regarding students’ asthma care in schools, the authors sent 166 school nurses in an urban school district an anonymous survey during the 2015-2016 school year. The survey asked about 21 factors that could delay or prevent students from returning to class and asked nurses’ agreement or disagreement with 25 additional statements.
The 130 respondents made up a 78% response rate. The institutions represented by the nurses included 44% elementary schools, 9% middle schools, 16% high schools, and 32% other (such as those who may serve multiple schools).
The majority of respondents (72%) agreed that asthma is one of the biggest health problems students face, particularly among middle and high school students (P less than .05). Most (74%) also said an albuterol inhaler at school could reduce the likelihood of students with asthma needing to leave school early.
The largest barrier to students returning to class was parents not providing an albuterol inhaler and/or a written order for an inhaler despite a request from the nurse, according to 69% of the respondents (P less than .05). In high schools in particular, another barrier was students simply not bringing their inhaler to school even though they usually carry one (P less than .01).
Only 15% of nurses saw disease severity as a significant barrier, and 17% cited the staff not adequately recognizing a student’s symptoms.
The researchers did not note use of external funding or author disclosures.
BALTIMORE – frequently because the parent did not provide an inhaler or did not provide a written order for one, according to new research. Only seven U.S. states have laws allowing schools to stock albuterol for students.
“Most students only have access to this lifesaving medication when they bring a personal inhaler,” Alexandra M. Sims, MD, of Children’s National Hospital in Washington and colleagues wrote in their abstract at the annual meeting of Pediatric Academic Societies. “Interventions that address medication availability may be an important step in removing obstacles to asthma care in school.”
One such option is a stock inhaler available for any students to use. National guidelines from the Centers for Disease Control and Prevention recommend that students with asthma have access to inhaled albuterol at school, yet most states do not have legislation related to albuterol stocking in schools, according to the Asthma and Allergy Foundation of America.
Not having access to rescue inhaler medication at school contributes to lost class time and referrals to the emergency department, the authors note in their background information. Yet, “in most U.S. jurisdictions, including the school district we examined, students need both a personal albuterol inhaler and a physician order to receive medication at school.”
To determine what barriers exist regarding students’ asthma care in schools, the authors sent 166 school nurses in an urban school district an anonymous survey during the 2015-2016 school year. The survey asked about 21 factors that could delay or prevent students from returning to class and asked nurses’ agreement or disagreement with 25 additional statements.
The 130 respondents made up a 78% response rate. The institutions represented by the nurses included 44% elementary schools, 9% middle schools, 16% high schools, and 32% other (such as those who may serve multiple schools).
The majority of respondents (72%) agreed that asthma is one of the biggest health problems students face, particularly among middle and high school students (P less than .05). Most (74%) also said an albuterol inhaler at school could reduce the likelihood of students with asthma needing to leave school early.
The largest barrier to students returning to class was parents not providing an albuterol inhaler and/or a written order for an inhaler despite a request from the nurse, according to 69% of the respondents (P less than .05). In high schools in particular, another barrier was students simply not bringing their inhaler to school even though they usually carry one (P less than .01).
Only 15% of nurses saw disease severity as a significant barrier, and 17% cited the staff not adequately recognizing a student’s symptoms.
The researchers did not note use of external funding or author disclosures.
BALTIMORE – frequently because the parent did not provide an inhaler or did not provide a written order for one, according to new research. Only seven U.S. states have laws allowing schools to stock albuterol for students.
“Most students only have access to this lifesaving medication when they bring a personal inhaler,” Alexandra M. Sims, MD, of Children’s National Hospital in Washington and colleagues wrote in their abstract at the annual meeting of Pediatric Academic Societies. “Interventions that address medication availability may be an important step in removing obstacles to asthma care in school.”
One such option is a stock inhaler available for any students to use. National guidelines from the Centers for Disease Control and Prevention recommend that students with asthma have access to inhaled albuterol at school, yet most states do not have legislation related to albuterol stocking in schools, according to the Asthma and Allergy Foundation of America.
Not having access to rescue inhaler medication at school contributes to lost class time and referrals to the emergency department, the authors note in their background information. Yet, “in most U.S. jurisdictions, including the school district we examined, students need both a personal albuterol inhaler and a physician order to receive medication at school.”
To determine what barriers exist regarding students’ asthma care in schools, the authors sent 166 school nurses in an urban school district an anonymous survey during the 2015-2016 school year. The survey asked about 21 factors that could delay or prevent students from returning to class and asked nurses’ agreement or disagreement with 25 additional statements.
The 130 respondents made up a 78% response rate. The institutions represented by the nurses included 44% elementary schools, 9% middle schools, 16% high schools, and 32% other (such as those who may serve multiple schools).
The majority of respondents (72%) agreed that asthma is one of the biggest health problems students face, particularly among middle and high school students (P less than .05). Most (74%) also said an albuterol inhaler at school could reduce the likelihood of students with asthma needing to leave school early.
The largest barrier to students returning to class was parents not providing an albuterol inhaler and/or a written order for an inhaler despite a request from the nurse, according to 69% of the respondents (P less than .05). In high schools in particular, another barrier was students simply not bringing their inhaler to school even though they usually carry one (P less than .01).
Only 15% of nurses saw disease severity as a significant barrier, and 17% cited the staff not adequately recognizing a student’s symptoms.
The researchers did not note use of external funding or author disclosures.
REPORTING FROM PAS 2019
Peanut desensitization comes at cost of anaphylaxis
based on a meta-analysis from more than 1,000 patients published in the Lancet.
In the Peanut Allergen immunotherapy, Clarifying the Evidence (PACE) systematic review and meta-analysis, Derek K. Chu, MD, of McMaster University, Hamilton, Ont., and colleagues reviewed 12 trials conducted between 2011 and 2018 with a total of 1,041 patients (median age, 9 years).
Overall, the risk of anaphylaxis was significantly higher among children who received oral immunotherapy, compared with no therapy (risk ratio, 3.12) as was anaphylaxis frequency (incidence rate ratio, 2.72) and use of epinephrine (RR, 2.21).
In addition, oral immunotherapy increased serious adverse events, compared with no therapy (RR, 1.92). Nonanaphylactic reactions also went up among oral immunotherapy patients, with increased risk for vomiting (RR, 1.79), angioedema (RR, 2.25), upper respiratory tract reactions (RR, 1.36), and lower respiratory tract infections (RR, 1.55).
Quality of life scores were not significantly different between patients who did and did not receive oral immunotherapy, the researchers noted.
The oral immunotherapy consisted of defatted, lightly roasted peanut flour in 10 studies, and a combination of peanut paste, peanut extract, or ground and defatted peanut in the other studies.
The oral immunotherapy did induce desensitization to peanuts in support of earlier studies including the subcutaneous immunotherapy trial, but “this outcome does not translate into achieving the clinical and patient-desired aim of less allergic reactions and anaphylaxis,” Dr. Chu and associates wrote.
However, “rather than take the view that these data denounce current research in oral immunotherapy as not successful, we instead suggest that this research has reached an important milestone in mechanistic but not clinical efficacy. From a clinical or biological perspective, the apparently paradoxical desensitization versus longitudinal clinical findings show the lability and unreliability of allergen thresholds identified during oral food challenges because patients often unpredictably reacted to previously tolerated doses outside of clinic,” they emphasized.
The findings were limited by several factors including the small sample size, compared with similar studies for asthma or cardiovascular conditions, and by incomplete or inconsistent data reporting, the researchers noted. However, the results are the most comprehensive to date, and support the need for food allergy treatments with better safety profiles, using peanut allergy immunotherapy as a model for other food allergies.
Dr. Chu and two other authors reported being investigators on a federally funded ongoing peanut oral immunotherapy trial. Two authors reported receiving a variety of grants from organizations such as the National Institutes of Health; the American Academy of Allergy, Asthma, & Immunology; or pharmaceutical companies.
SOURCE: Chu DK et al. Lancet. 2019 June 1;393:2222-32.
“The key criticism of this systematic review is inherent in its method because studies with different designs were grouped together,” Graham Roberts, MD, and Elizabeth Angier, MD, wrote in an accompanying editorial. In addition, the studies chosen did not account for the development of long-term peanut tolerance after the therapy was discontinued.
Also, the researchers did not factor in the variation in patterns of anaphylactic events, with patients in the treatment groups having events at home in conjunction with daily peanut doses, while the control patients would have had events mainly away from home.
“Unfortunately, the trials have not provided information about which participants benefited most from the intervention,” they wrote.
“Trading treatment-related side effects at home for allergic reactions to accidental exposures out of the house [i.e., in social situations] might beneficial for some patients,” they added. However, more research is needed to determine which patients would benefit from different treatment options at home and outside the home. The less effective but safer option of epicutaneous immunotherapy might be preferred by some patients. And early introduction of peanut products during infancy may prevent many cases of peanut allergy.
Dr. Roberts and Dr. Angier are at the University of Southampton (England). Both are members of the European Academy of Allergy and Clinical Immunology Allergen Immunotherapy Guidelines Group, which has recently published guidelines on immunotherapy. They wrote an editorial to accompany the article by Chu et al (Lancet. 2019 June 1;393:2180-1). They had no financial conflicts to disclose.
“The key criticism of this systematic review is inherent in its method because studies with different designs were grouped together,” Graham Roberts, MD, and Elizabeth Angier, MD, wrote in an accompanying editorial. In addition, the studies chosen did not account for the development of long-term peanut tolerance after the therapy was discontinued.
Also, the researchers did not factor in the variation in patterns of anaphylactic events, with patients in the treatment groups having events at home in conjunction with daily peanut doses, while the control patients would have had events mainly away from home.
“Unfortunately, the trials have not provided information about which participants benefited most from the intervention,” they wrote.
“Trading treatment-related side effects at home for allergic reactions to accidental exposures out of the house [i.e., in social situations] might beneficial for some patients,” they added. However, more research is needed to determine which patients would benefit from different treatment options at home and outside the home. The less effective but safer option of epicutaneous immunotherapy might be preferred by some patients. And early introduction of peanut products during infancy may prevent many cases of peanut allergy.
Dr. Roberts and Dr. Angier are at the University of Southampton (England). Both are members of the European Academy of Allergy and Clinical Immunology Allergen Immunotherapy Guidelines Group, which has recently published guidelines on immunotherapy. They wrote an editorial to accompany the article by Chu et al (Lancet. 2019 June 1;393:2180-1). They had no financial conflicts to disclose.
“The key criticism of this systematic review is inherent in its method because studies with different designs were grouped together,” Graham Roberts, MD, and Elizabeth Angier, MD, wrote in an accompanying editorial. In addition, the studies chosen did not account for the development of long-term peanut tolerance after the therapy was discontinued.
Also, the researchers did not factor in the variation in patterns of anaphylactic events, with patients in the treatment groups having events at home in conjunction with daily peanut doses, while the control patients would have had events mainly away from home.
“Unfortunately, the trials have not provided information about which participants benefited most from the intervention,” they wrote.
“Trading treatment-related side effects at home for allergic reactions to accidental exposures out of the house [i.e., in social situations] might beneficial for some patients,” they added. However, more research is needed to determine which patients would benefit from different treatment options at home and outside the home. The less effective but safer option of epicutaneous immunotherapy might be preferred by some patients. And early introduction of peanut products during infancy may prevent many cases of peanut allergy.
Dr. Roberts and Dr. Angier are at the University of Southampton (England). Both are members of the European Academy of Allergy and Clinical Immunology Allergen Immunotherapy Guidelines Group, which has recently published guidelines on immunotherapy. They wrote an editorial to accompany the article by Chu et al (Lancet. 2019 June 1;393:2180-1). They had no financial conflicts to disclose.
based on a meta-analysis from more than 1,000 patients published in the Lancet.
In the Peanut Allergen immunotherapy, Clarifying the Evidence (PACE) systematic review and meta-analysis, Derek K. Chu, MD, of McMaster University, Hamilton, Ont., and colleagues reviewed 12 trials conducted between 2011 and 2018 with a total of 1,041 patients (median age, 9 years).
Overall, the risk of anaphylaxis was significantly higher among children who received oral immunotherapy, compared with no therapy (risk ratio, 3.12) as was anaphylaxis frequency (incidence rate ratio, 2.72) and use of epinephrine (RR, 2.21).
In addition, oral immunotherapy increased serious adverse events, compared with no therapy (RR, 1.92). Nonanaphylactic reactions also went up among oral immunotherapy patients, with increased risk for vomiting (RR, 1.79), angioedema (RR, 2.25), upper respiratory tract reactions (RR, 1.36), and lower respiratory tract infections (RR, 1.55).
Quality of life scores were not significantly different between patients who did and did not receive oral immunotherapy, the researchers noted.
The oral immunotherapy consisted of defatted, lightly roasted peanut flour in 10 studies, and a combination of peanut paste, peanut extract, or ground and defatted peanut in the other studies.
The oral immunotherapy did induce desensitization to peanuts in support of earlier studies including the subcutaneous immunotherapy trial, but “this outcome does not translate into achieving the clinical and patient-desired aim of less allergic reactions and anaphylaxis,” Dr. Chu and associates wrote.
However, “rather than take the view that these data denounce current research in oral immunotherapy as not successful, we instead suggest that this research has reached an important milestone in mechanistic but not clinical efficacy. From a clinical or biological perspective, the apparently paradoxical desensitization versus longitudinal clinical findings show the lability and unreliability of allergen thresholds identified during oral food challenges because patients often unpredictably reacted to previously tolerated doses outside of clinic,” they emphasized.
The findings were limited by several factors including the small sample size, compared with similar studies for asthma or cardiovascular conditions, and by incomplete or inconsistent data reporting, the researchers noted. However, the results are the most comprehensive to date, and support the need for food allergy treatments with better safety profiles, using peanut allergy immunotherapy as a model for other food allergies.
Dr. Chu and two other authors reported being investigators on a federally funded ongoing peanut oral immunotherapy trial. Two authors reported receiving a variety of grants from organizations such as the National Institutes of Health; the American Academy of Allergy, Asthma, & Immunology; or pharmaceutical companies.
SOURCE: Chu DK et al. Lancet. 2019 June 1;393:2222-32.
based on a meta-analysis from more than 1,000 patients published in the Lancet.
In the Peanut Allergen immunotherapy, Clarifying the Evidence (PACE) systematic review and meta-analysis, Derek K. Chu, MD, of McMaster University, Hamilton, Ont., and colleagues reviewed 12 trials conducted between 2011 and 2018 with a total of 1,041 patients (median age, 9 years).
Overall, the risk of anaphylaxis was significantly higher among children who received oral immunotherapy, compared with no therapy (risk ratio, 3.12) as was anaphylaxis frequency (incidence rate ratio, 2.72) and use of epinephrine (RR, 2.21).
In addition, oral immunotherapy increased serious adverse events, compared with no therapy (RR, 1.92). Nonanaphylactic reactions also went up among oral immunotherapy patients, with increased risk for vomiting (RR, 1.79), angioedema (RR, 2.25), upper respiratory tract reactions (RR, 1.36), and lower respiratory tract infections (RR, 1.55).
Quality of life scores were not significantly different between patients who did and did not receive oral immunotherapy, the researchers noted.
The oral immunotherapy consisted of defatted, lightly roasted peanut flour in 10 studies, and a combination of peanut paste, peanut extract, or ground and defatted peanut in the other studies.
The oral immunotherapy did induce desensitization to peanuts in support of earlier studies including the subcutaneous immunotherapy trial, but “this outcome does not translate into achieving the clinical and patient-desired aim of less allergic reactions and anaphylaxis,” Dr. Chu and associates wrote.
However, “rather than take the view that these data denounce current research in oral immunotherapy as not successful, we instead suggest that this research has reached an important milestone in mechanistic but not clinical efficacy. From a clinical or biological perspective, the apparently paradoxical desensitization versus longitudinal clinical findings show the lability and unreliability of allergen thresholds identified during oral food challenges because patients often unpredictably reacted to previously tolerated doses outside of clinic,” they emphasized.
The findings were limited by several factors including the small sample size, compared with similar studies for asthma or cardiovascular conditions, and by incomplete or inconsistent data reporting, the researchers noted. However, the results are the most comprehensive to date, and support the need for food allergy treatments with better safety profiles, using peanut allergy immunotherapy as a model for other food allergies.
Dr. Chu and two other authors reported being investigators on a federally funded ongoing peanut oral immunotherapy trial. Two authors reported receiving a variety of grants from organizations such as the National Institutes of Health; the American Academy of Allergy, Asthma, & Immunology; or pharmaceutical companies.
SOURCE: Chu DK et al. Lancet. 2019 June 1;393:2222-32.
FROM THE LANCET