News

Tuberculosis (TB) kills more people each year than any other infectious disease. Not only the patients, but their nearest and dearest are at risk, as well. They are more likely to acquire latent TB infection and many will progress to active TB.

NIH is launching a study to compare delamanid, a new drug for multidrug-resistant TB (MDR-TB) with isoniazid, the long-time standard. The study hypothesis is that prophylactic delamanid will better protect family and other household members of patients with MDR-TB. Existing treatments for MDR-TB are often highly toxic and poorly tolerated, putting patients at risk while curing them only about half the time. Delamanid is one of the first drugs available specifically to treat people with MDR-TB and the first formulation suitable for children.

“A highly effective preventive TB therapy for vulnerable household members of people with active MDR-TB disease would be a game-changer in TB care,” says Dr. Anneke Hesseling, MD, PhD, one of the study leaders.

The phase 3 trial, Protecting Households on Exposure to Newly Diagnosed Index Multidrug-Resistant Tuberculosis Patients (PHOENIx MDR-TB), will take place at > 27 sites in at ≥ 12 countries. The researchers plan to enroll 2,158 adults being treated for confirmed active MDR-TB and 3,452 members of their households who are at high risk for developing active TB. The household members will be assigned randomly to receive oral delamanid daily for 26 weeks or oral isoniazid plus vitamin B6 daily for 26 weeks. All at-risk members of the same household will receive the same drug regimen.

Every 2 to 12 weeks, participating household contacts will have physical exams and other health assessments. The researchers will follow them for 96 weeks. Final results are expected in 2024.

TB is the leading cause of death among people with HIV. Both delamanid and isoniazid have minimal potential for interacting with antiretroviral drugs. Study participants with HIV who have not yet begun treatment will be referred to local health care providers for antiretroviral treatment.

Tuberculosis (TB) kills more people each year than any other infectious disease. Not only the patients, but their nearest and dearest are at risk, as well. They are more likely to acquire latent TB infection and many will progress to active TB.

NIH is launching a study to compare delamanid, a new drug for multidrug-resistant TB (MDR-TB) with isoniazid, the long-time standard. The study hypothesis is that prophylactic delamanid will better protect family and other household members of patients with MDR-TB. Existing treatments for MDR-TB are often highly toxic and poorly tolerated, putting patients at risk while curing them only about half the time. Delamanid is one of the first drugs available specifically to treat people with MDR-TB and the first formulation suitable for children.

“A highly effective preventive TB therapy for vulnerable household members of people with active MDR-TB disease would be a game-changer in TB care,” says Dr. Anneke Hesseling, MD, PhD, one of the study leaders.

The phase 3 trial, Protecting Households on Exposure to Newly Diagnosed Index Multidrug-Resistant Tuberculosis Patients (PHOENIx MDR-TB), will take place at > 27 sites in at ≥ 12 countries. The researchers plan to enroll 2,158 adults being treated for confirmed active MDR-TB and 3,452 members of their households who are at high risk for developing active TB. The household members will be assigned randomly to receive oral delamanid daily for 26 weeks or oral isoniazid plus vitamin B6 daily for 26 weeks. All at-risk members of the same household will receive the same drug regimen.

Every 2 to 12 weeks, participating household contacts will have physical exams and other health assessments. The researchers will follow them for 96 weeks. Final results are expected in 2024.

TB is the leading cause of death among people with HIV. Both delamanid and isoniazid have minimal potential for interacting with antiretroviral drugs. Study participants with HIV who have not yet begun treatment will be referred to local health care providers for antiretroviral treatment.

Tuberculosis (TB) kills more people each year than any other infectious disease. Not only the patients, but their nearest and dearest are at risk, as well. They are more likely to acquire latent TB infection and many will progress to active TB.

NIH is launching a study to compare delamanid, a new drug for multidrug-resistant TB (MDR-TB) with isoniazid, the long-time standard. The study hypothesis is that prophylactic delamanid will better protect family and other household members of patients with MDR-TB. Existing treatments for MDR-TB are often highly toxic and poorly tolerated, putting patients at risk while curing them only about half the time. Delamanid is one of the first drugs available specifically to treat people with MDR-TB and the first formulation suitable for children.

“A highly effective preventive TB therapy for vulnerable household members of people with active MDR-TB disease would be a game-changer in TB care,” says Dr. Anneke Hesseling, MD, PhD, one of the study leaders.

The phase 3 trial, Protecting Households on Exposure to Newly Diagnosed Index Multidrug-Resistant Tuberculosis Patients (PHOENIx MDR-TB), will take place at > 27 sites in at ≥ 12 countries. The researchers plan to enroll 2,158 adults being treated for confirmed active MDR-TB and 3,452 members of their households who are at high risk for developing active TB. The household members will be assigned randomly to receive oral delamanid daily for 26 weeks or oral isoniazid plus vitamin B6 daily for 26 weeks. All at-risk members of the same household will receive the same drug regimen.

Every 2 to 12 weeks, participating household contacts will have physical exams and other health assessments. The researchers will follow them for 96 weeks. Final results are expected in 2024.

TB is the leading cause of death among people with HIV. Both delamanid and isoniazid have minimal potential for interacting with antiretroviral drugs. Study participants with HIV who have not yet begun treatment will be referred to local health care providers for antiretroviral treatment.

Native American communities have experienced the largest increase in drug overdose deaths of all racial/ethnic groups in the US. Between 1999 and 2015, drug overdose deaths rose > 500%. To help ensure that American Indians and Alaska Natives (AI/AN) get the treatment they need, the Indian Health Service (IHS) has released Special General Memorandum 2019-01: Assuring Access to Medication Assisted Treatment for Opioid Use Disorder. It requires all IHS federal facilities to:

• Identify opioid use disorder (OUD) treatment resources in their local areas;
• Create an action plan, no later than Dec. 11, 2019; and
• Provide or coordinate patient access to medication-assisted treatment (MAT), specifically increasing access to culturally appropriate prevention, treatment, and recovery support services.

MAT is a comprehensive evidence-based approach that combines pharmacologic interventions with substance abuse counseling and culturally sensitive social support.

The IHS has recently taken other steps to further facilitate MAT access in tribal communities. For example, it has added 3 FDA-approved medications to the National Core Formulary: buprenorphine, buprenorphine/naloxone, and injectable naltrexone, all of which relieve withdrawal symptoms and psychological cravings, supporting adherence to treatment and reducing illicit opioid use.

In addition, the IHS has published the Internet Eligible Controlled Substance Provider Designation Policy. This policy, established in 2018, is designed to increase access to treatment for AI/AN who live in rural or remote areas, where it can be difficult to access a provider with the necessary training and Drug Enforcement Administration approval to prescribe buprenorphine in an outpatient or office-based setting. Once approved, IHS, tribal, and urban Indian organization health care providers can prescribe controlled substances for MAT through telemedicine.

In 2018, the IHS also launched a new website (www.IHS.gov/opioids) to share information about opioids with patients, health care providers, tribal leaders, tribal and urban program administrators, and other community members. The site includes information on approaches to prevent opioid abuse, pain management, recovery tools, and funding opportunities.

Native American communities have experienced the largest increase in drug overdose deaths of all racial/ethnic groups in the US. Between 1999 and 2015, drug overdose deaths rose > 500%. To help ensure that American Indians and Alaska Natives (AI/AN) get the treatment they need, the Indian Health Service (IHS) has released Special General Memorandum 2019-01: Assuring Access to Medication Assisted Treatment for Opioid Use Disorder. It requires all IHS federal facilities to:

• Identify opioid use disorder (OUD) treatment resources in their local areas;
• Create an action plan, no later than Dec. 11, 2019; and
• Provide or coordinate patient access to medication-assisted treatment (MAT), specifically increasing access to culturally appropriate prevention, treatment, and recovery support services.

MAT is a comprehensive evidence-based approach that combines pharmacologic interventions with substance abuse counseling and culturally sensitive social support.

The IHS has recently taken other steps to further facilitate MAT access in tribal communities. For example, it has added 3 FDA-approved medications to the National Core Formulary: buprenorphine, buprenorphine/naloxone, and injectable naltrexone, all of which relieve withdrawal symptoms and psychological cravings, supporting adherence to treatment and reducing illicit opioid use.

In addition, the IHS has published the Internet Eligible Controlled Substance Provider Designation Policy. This policy, established in 2018, is designed to increase access to treatment for AI/AN who live in rural or remote areas, where it can be difficult to access a provider with the necessary training and Drug Enforcement Administration approval to prescribe buprenorphine in an outpatient or office-based setting. Once approved, IHS, tribal, and urban Indian organization health care providers can prescribe controlled substances for MAT through telemedicine.

In 2018, the IHS also launched a new website (www.IHS.gov/opioids) to share information about opioids with patients, health care providers, tribal leaders, tribal and urban program administrators, and other community members. The site includes information on approaches to prevent opioid abuse, pain management, recovery tools, and funding opportunities.

Native American communities have experienced the largest increase in drug overdose deaths of all racial/ethnic groups in the US. Between 1999 and 2015, drug overdose deaths rose > 500%. To help ensure that American Indians and Alaska Natives (AI/AN) get the treatment they need, the Indian Health Service (IHS) has released Special General Memorandum 2019-01: Assuring Access to Medication Assisted Treatment for Opioid Use Disorder. It requires all IHS federal facilities to:

• Identify opioid use disorder (OUD) treatment resources in their local areas;
• Create an action plan, no later than Dec. 11, 2019; and
• Provide or coordinate patient access to medication-assisted treatment (MAT), specifically increasing access to culturally appropriate prevention, treatment, and recovery support services.

MAT is a comprehensive evidence-based approach that combines pharmacologic interventions with substance abuse counseling and culturally sensitive social support.

The IHS has recently taken other steps to further facilitate MAT access in tribal communities. For example, it has added 3 FDA-approved medications to the National Core Formulary: buprenorphine, buprenorphine/naloxone, and injectable naltrexone, all of which relieve withdrawal symptoms and psychological cravings, supporting adherence to treatment and reducing illicit opioid use.

In addition, the IHS has published the Internet Eligible Controlled Substance Provider Designation Policy. This policy, established in 2018, is designed to increase access to treatment for AI/AN who live in rural or remote areas, where it can be difficult to access a provider with the necessary training and Drug Enforcement Administration approval to prescribe buprenorphine in an outpatient or office-based setting. Once approved, IHS, tribal, and urban Indian organization health care providers can prescribe controlled substances for MAT through telemedicine.

In 2018, the IHS also launched a new website (www.IHS.gov/opioids) to share information about opioids with patients, health care providers, tribal leaders, tribal and urban program administrators, and other community members. The site includes information on approaches to prevent opioid abuse, pain management, recovery tools, and funding opportunities.

Use of inhaled corticosteroids may lower the risk of lung cancer in patients with chronic obstructive pulmonary disease, and continued use may also reduce lung cancer risk, recent research from the European Respiratory Journal has shown.

“The appropriate use of [inhaled corticosteroids] ICS in [chronic obstructive pulmonary disease] COPD patients is often debated and not all patients might benefit from the use of ICS. The clinical benefits and risk of use in an individual patient must be weighed by the physician,” wrote Adam J.N. Raymakers, MSc, PhD, of the University of British Columbia’s Collaboration for Outcomes Research and Evaluation (CORE), Vancouver, B.C., and colleagues.

“This study, however, indicates that potential benefits may accrue from ICS use in COPD patients in terms of reduced lung cancer risk, and that sustained use may be associated with reduced risk of lung cancer.”

Dr. Raymakers and colleagues did an analysis of 39,676 patients with COPD (mean age, 70.7 years; 53% female) who received ICS between 1997 and 2007 and linked those patients to a registry of cancer patients in British Columbia. The linked databases included the Medical Services Plan (MSP) payment information file, Discharge Abstract Database (DAD), PharmaNet data file, and the British Columbia Cancer Registry (BCCR). The researchers determined a patient had COPD if he or she received three or more prescriptions related to COPD, while ICS exposure was analyzed in the context of a patient’s ICS exposure, cumulative duration, cumulative dose, and weighted cumulative duration and dose.

The analysis revealed 372,075 prescriptions for ICS were dispensed and 71.2% of the patients were “distinct users” of ICS, with patients filling a median of eight prescriptions at mean 5.2 years of follow-up. Fluticasone propionate was the most common ICS prescribed at a dose of 0.64 mg per day, and patients had median 60 days of ICS supplied per person.

Overall, there were 994 cases of lung cancer (2.5%), and exposure to ICS was linked to a 30% reduction in lung cancer risk (hazard ratio, 0.70; 95% confidence interval, 0.61-0.80), while recency-weighted duration of ICS exposure was linked to a 26% reduction in lung cancer risk (HR, 0.74; 95% CI, 0.66-0.87). There was a 43% reduced risk of lung cancer per gram of ICS when the data were measured by recency-weighted cumulative dosage.

In a multivariate analysis, ICS use was associated with a 30% reduction in risk of non–small cell lung cancer (HR, 0.70; 95% CI, 0.60-0.82), which the researchers said suggests ICS provides a protective effect for patients against lung cancer. “These results highlight the importance of properly identifying which patients might be at the highest risk of lung cancer, to enhance the therapeutic benefits of ICS in these COPD patients,” they wrote.

This study received funding from the Canadian Institutes of Health Research. The authors report no conflicts of interest.

SOURCE: Raymakers A, et al. Eur Respir J. 2019. doi: 10.1183/13993003.01257-2018.

Use of inhaled corticosteroids may lower the risk of lung cancer in patients with chronic obstructive pulmonary disease, and continued use may also reduce lung cancer risk, recent research from the European Respiratory Journal has shown.

“The appropriate use of [inhaled corticosteroids] ICS in [chronic obstructive pulmonary disease] COPD patients is often debated and not all patients might benefit from the use of ICS. The clinical benefits and risk of use in an individual patient must be weighed by the physician,” wrote Adam J.N. Raymakers, MSc, PhD, of the University of British Columbia’s Collaboration for Outcomes Research and Evaluation (CORE), Vancouver, B.C., and colleagues.

“This study, however, indicates that potential benefits may accrue from ICS use in COPD patients in terms of reduced lung cancer risk, and that sustained use may be associated with reduced risk of lung cancer.”

Dr. Raymakers and colleagues did an analysis of 39,676 patients with COPD (mean age, 70.7 years; 53% female) who received ICS between 1997 and 2007 and linked those patients to a registry of cancer patients in British Columbia. The linked databases included the Medical Services Plan (MSP) payment information file, Discharge Abstract Database (DAD), PharmaNet data file, and the British Columbia Cancer Registry (BCCR). The researchers determined a patient had COPD if he or she received three or more prescriptions related to COPD, while ICS exposure was analyzed in the context of a patient’s ICS exposure, cumulative duration, cumulative dose, and weighted cumulative duration and dose.

The analysis revealed 372,075 prescriptions for ICS were dispensed and 71.2% of the patients were “distinct users” of ICS, with patients filling a median of eight prescriptions at mean 5.2 years of follow-up. Fluticasone propionate was the most common ICS prescribed at a dose of 0.64 mg per day, and patients had median 60 days of ICS supplied per person.

Overall, there were 994 cases of lung cancer (2.5%), and exposure to ICS was linked to a 30% reduction in lung cancer risk (hazard ratio, 0.70; 95% confidence interval, 0.61-0.80), while recency-weighted duration of ICS exposure was linked to a 26% reduction in lung cancer risk (HR, 0.74; 95% CI, 0.66-0.87). There was a 43% reduced risk of lung cancer per gram of ICS when the data were measured by recency-weighted cumulative dosage.

In a multivariate analysis, ICS use was associated with a 30% reduction in risk of non–small cell lung cancer (HR, 0.70; 95% CI, 0.60-0.82), which the researchers said suggests ICS provides a protective effect for patients against lung cancer. “These results highlight the importance of properly identifying which patients might be at the highest risk of lung cancer, to enhance the therapeutic benefits of ICS in these COPD patients,” they wrote.

This study received funding from the Canadian Institutes of Health Research. The authors report no conflicts of interest.

SOURCE: Raymakers A, et al. Eur Respir J. 2019. doi: 10.1183/13993003.01257-2018.

Use of inhaled corticosteroids may lower the risk of lung cancer in patients with chronic obstructive pulmonary disease, and continued use may also reduce lung cancer risk, recent research from the European Respiratory Journal has shown.

“The appropriate use of [inhaled corticosteroids] ICS in [chronic obstructive pulmonary disease] COPD patients is often debated and not all patients might benefit from the use of ICS. The clinical benefits and risk of use in an individual patient must be weighed by the physician,” wrote Adam J.N. Raymakers, MSc, PhD, of the University of British Columbia’s Collaboration for Outcomes Research and Evaluation (CORE), Vancouver, B.C., and colleagues.

“This study, however, indicates that potential benefits may accrue from ICS use in COPD patients in terms of reduced lung cancer risk, and that sustained use may be associated with reduced risk of lung cancer.”

Dr. Raymakers and colleagues did an analysis of 39,676 patients with COPD (mean age, 70.7 years; 53% female) who received ICS between 1997 and 2007 and linked those patients to a registry of cancer patients in British Columbia. The linked databases included the Medical Services Plan (MSP) payment information file, Discharge Abstract Database (DAD), PharmaNet data file, and the British Columbia Cancer Registry (BCCR). The researchers determined a patient had COPD if he or she received three or more prescriptions related to COPD, while ICS exposure was analyzed in the context of a patient’s ICS exposure, cumulative duration, cumulative dose, and weighted cumulative duration and dose.

The analysis revealed 372,075 prescriptions for ICS were dispensed and 71.2% of the patients were “distinct users” of ICS, with patients filling a median of eight prescriptions at mean 5.2 years of follow-up. Fluticasone propionate was the most common ICS prescribed at a dose of 0.64 mg per day, and patients had median 60 days of ICS supplied per person.

Overall, there were 994 cases of lung cancer (2.5%), and exposure to ICS was linked to a 30% reduction in lung cancer risk (hazard ratio, 0.70; 95% confidence interval, 0.61-0.80), while recency-weighted duration of ICS exposure was linked to a 26% reduction in lung cancer risk (HR, 0.74; 95% CI, 0.66-0.87). There was a 43% reduced risk of lung cancer per gram of ICS when the data were measured by recency-weighted cumulative dosage.

In a multivariate analysis, ICS use was associated with a 30% reduction in risk of non–small cell lung cancer (HR, 0.70; 95% CI, 0.60-0.82), which the researchers said suggests ICS provides a protective effect for patients against lung cancer. “These results highlight the importance of properly identifying which patients might be at the highest risk of lung cancer, to enhance the therapeutic benefits of ICS in these COPD patients,” they wrote.

This study received funding from the Canadian Institutes of Health Research. The authors report no conflicts of interest.

SOURCE: Raymakers A, et al. Eur Respir J. 2019. doi: 10.1183/13993003.01257-2018.

The pediatric hexavalent vaccine (DTaP-[inactivated poliovirus] IPV-[hepatitis B] HepB-[Haemophilis influenzae type b] Hib) should be included as an option in the Vaccines for Children (VFC) program for the infant series at ages 2, 4, and 6 months, according to unanimous votes at a meeting of the Centers for Disease Control and Prevention’s Advisory Committee on Immunization Practices.

copyright itsmejust/Thinkstock

The addition of the vaccine to the VFC program required no motions on the part of the committee, but involved separate votes on each component of the vaccine.

Combination vaccination has been associated with increased coverage and more likely completion of the full infant vaccine series, said Sara Oliver, MD, of the CDC’s National Center for Immunization and Respiratory Diseases.

The new vaccine is being developed jointly by Sanofi and Merck, and has been approved by the Food and Drug Administration for use in children through age 4 years.

Dr. Oliver presented evidence that the safety profile of the combination vaccine is consistent with that of the component vaccines. In addition, “use of combination vaccines can reduce the number of injections patient receive and alleviate concern associated with the number of injections,” she said. However, “considerations should include provider assessment, patient preference, and the potential for adverse events.”

The vote does not make any changes to the current vaccination schedule, but adds the combination vaccine as an option in the VFC program, although it will not be available until 2021 in order to ensure sufficient supply, Dr. Oliver noted.

The combination vaccination work group considered whether the new vaccine should be preferentially recommended for American Indian and Alaskan Native populations, but they concluded that post–dose one immunogenicity data are needed before such a preferential recommendation can be made.

The ACIP members had no financial conflicts to disclose.

The pediatric hexavalent vaccine (DTaP-[inactivated poliovirus] IPV-[hepatitis B] HepB-[Haemophilis influenzae type b] Hib) should be included as an option in the Vaccines for Children (VFC) program for the infant series at ages 2, 4, and 6 months, according to unanimous votes at a meeting of the Centers for Disease Control and Prevention’s Advisory Committee on Immunization Practices.

copyright itsmejust/Thinkstock

The addition of the vaccine to the VFC program required no motions on the part of the committee, but involved separate votes on each component of the vaccine.

Combination vaccination has been associated with increased coverage and more likely completion of the full infant vaccine series, said Sara Oliver, MD, of the CDC’s National Center for Immunization and Respiratory Diseases.

The new vaccine is being developed jointly by Sanofi and Merck, and has been approved by the Food and Drug Administration for use in children through age 4 years.

Dr. Oliver presented evidence that the safety profile of the combination vaccine is consistent with that of the component vaccines. In addition, “use of combination vaccines can reduce the number of injections patient receive and alleviate concern associated with the number of injections,” she said. However, “considerations should include provider assessment, patient preference, and the potential for adverse events.”

The vote does not make any changes to the current vaccination schedule, but adds the combination vaccine as an option in the VFC program, although it will not be available until 2021 in order to ensure sufficient supply, Dr. Oliver noted.

The combination vaccination work group considered whether the new vaccine should be preferentially recommended for American Indian and Alaskan Native populations, but they concluded that post–dose one immunogenicity data are needed before such a preferential recommendation can be made.

The ACIP members had no financial conflicts to disclose.

The pediatric hexavalent vaccine (DTaP-[inactivated poliovirus] IPV-[hepatitis B] HepB-[Haemophilis influenzae type b] Hib) should be included as an option in the Vaccines for Children (VFC) program for the infant series at ages 2, 4, and 6 months, according to unanimous votes at a meeting of the Centers for Disease Control and Prevention’s Advisory Committee on Immunization Practices.

copyright itsmejust/Thinkstock

The addition of the vaccine to the VFC program required no motions on the part of the committee, but involved separate votes on each component of the vaccine.

Combination vaccination has been associated with increased coverage and more likely completion of the full infant vaccine series, said Sara Oliver, MD, of the CDC’s National Center for Immunization and Respiratory Diseases.

The new vaccine is being developed jointly by Sanofi and Merck, and has been approved by the Food and Drug Administration for use in children through age 4 years.

Dr. Oliver presented evidence that the safety profile of the combination vaccine is consistent with that of the component vaccines. In addition, “use of combination vaccines can reduce the number of injections patient receive and alleviate concern associated with the number of injections,” she said. However, “considerations should include provider assessment, patient preference, and the potential for adverse events.”

The vote does not make any changes to the current vaccination schedule, but adds the combination vaccine as an option in the VFC program, although it will not be available until 2021 in order to ensure sufficient supply, Dr. Oliver noted.

The combination vaccination work group considered whether the new vaccine should be preferentially recommended for American Indian and Alaskan Native populations, but they concluded that post–dose one immunogenicity data are needed before such a preferential recommendation can be made.

The ACIP members had no financial conflicts to disclose.

Pneumococcal vaccination with the 13-valent pneumococcal conjugate vaccine (PCV13) based on shared clinical decision making is recommended for immunocompetent adults aged 65 years and older who have not previously received PCV13, and all adults aged 65 years and older should continue to receive the pneumococcal polysaccharide vaccine (PPSV23), according to a vote at a meeting of the Centers for Disease Control and Prevention’s Advisory Committee on Immunization Practices.

bowdenimages/iStock/Getty Images

The motion passed with an 11-1 vote after members voted down two other options to either discontinue or continue the current recommendation of PCV13 for all immunocompetent adults aged 65 years and older. The current recommendation for PCV13 for adults aged 65 years and older has been in place since 2014.

The pneumococcal work group assessed indirect effects of the pediatric PCV vaccination on older adults prior to 2014 and since 2014, and what additional benefits might be expected if routine vaccination of older adults continued.

“Indirect effects have been observed in all age groups” said Almea Matanock, MD, of the CDC’s National Center for Immunization and Respiratory Diseases. Although there were no safety concerns, the public health impact of continued vaccination of adults was minimal.

Although PCV13 resulted in a 75% reduction in vaccine-type invasive pneumococcal disease and a 45% reduction in vaccine-type nonbacteremic pneumonia in 2014, the annual number needed to vaccinate to prevent a single case of outpatient pneumonia was 2,600, said Dr. Matanock.

Dr. Matanock presented key issues from the Evidence to Recommendations Framework for and against the recommendation for PCV13 in older adults. Work group comments in favor of continuing the recommendation for PCV13 in older adults included effective disease prevention and the potential negative impact on the importance of adult vaccines if the vaccine was no longer recommended. However, some work group members and committee members expressed concern about resource allocation and steering vaccines away from younger age groups in whom they have been more consistently effective.

Paul Hunter, MD, of the City of Milwaukee Health Department, voted against the shared clinical decision making, and instead favored discontinuing the recommendation for PCV13 for older adults. “I think clinicians need a clear message,” he said, adding that “the public health bang for the buck is with the kids.”

“I think there was a recognition that the population level benefit is minimal,” said work group chair Grace Lee, MD.

Although the work group recognized some benefit for older adults, the burden of disease for PCV-specific disease is low, compared with all-cause pneumonia, said Dr. Lee of Lucile Packard Children’s Hospital at Stanford, Calif. However, the recommendation for shared clinical decision making allows for potential insurance coverage of the vaccine for adults who decide after discussion with their health care provider that they would benefit.

“We are still unpacking this construct” of shared clinical decision making, which in this case applies to adults without immunocompromising conditions, and is more of a provider assessment than a risk assessment, she said.

The ACIP members had no financial conflicts to disclose.

Pneumococcal vaccination with the 13-valent pneumococcal conjugate vaccine (PCV13) based on shared clinical decision making is recommended for immunocompetent adults aged 65 years and older who have not previously received PCV13, and all adults aged 65 years and older should continue to receive the pneumococcal polysaccharide vaccine (PPSV23), according to a vote at a meeting of the Centers for Disease Control and Prevention’s Advisory Committee on Immunization Practices.

bowdenimages/iStock/Getty Images

The motion passed with an 11-1 vote after members voted down two other options to either discontinue or continue the current recommendation of PCV13 for all immunocompetent adults aged 65 years and older. The current recommendation for PCV13 for adults aged 65 years and older has been in place since 2014.

The pneumococcal work group assessed indirect effects of the pediatric PCV vaccination on older adults prior to 2014 and since 2014, and what additional benefits might be expected if routine vaccination of older adults continued.

“Indirect effects have been observed in all age groups” said Almea Matanock, MD, of the CDC’s National Center for Immunization and Respiratory Diseases. Although there were no safety concerns, the public health impact of continued vaccination of adults was minimal.

Although PCV13 resulted in a 75% reduction in vaccine-type invasive pneumococcal disease and a 45% reduction in vaccine-type nonbacteremic pneumonia in 2014, the annual number needed to vaccinate to prevent a single case of outpatient pneumonia was 2,600, said Dr. Matanock.

Dr. Matanock presented key issues from the Evidence to Recommendations Framework for and against the recommendation for PCV13 in older adults. Work group comments in favor of continuing the recommendation for PCV13 in older adults included effective disease prevention and the potential negative impact on the importance of adult vaccines if the vaccine was no longer recommended. However, some work group members and committee members expressed concern about resource allocation and steering vaccines away from younger age groups in whom they have been more consistently effective.

Paul Hunter, MD, of the City of Milwaukee Health Department, voted against the shared clinical decision making, and instead favored discontinuing the recommendation for PCV13 for older adults. “I think clinicians need a clear message,” he said, adding that “the public health bang for the buck is with the kids.”

“I think there was a recognition that the population level benefit is minimal,” said work group chair Grace Lee, MD.

Although the work group recognized some benefit for older adults, the burden of disease for PCV-specific disease is low, compared with all-cause pneumonia, said Dr. Lee of Lucile Packard Children’s Hospital at Stanford, Calif. However, the recommendation for shared clinical decision making allows for potential insurance coverage of the vaccine for adults who decide after discussion with their health care provider that they would benefit.

“We are still unpacking this construct” of shared clinical decision making, which in this case applies to adults without immunocompromising conditions, and is more of a provider assessment than a risk assessment, she said.

The ACIP members had no financial conflicts to disclose.

Pneumococcal vaccination with the 13-valent pneumococcal conjugate vaccine (PCV13) based on shared clinical decision making is recommended for immunocompetent adults aged 65 years and older who have not previously received PCV13, and all adults aged 65 years and older should continue to receive the pneumococcal polysaccharide vaccine (PPSV23), according to a vote at a meeting of the Centers for Disease Control and Prevention’s Advisory Committee on Immunization Practices.

bowdenimages/iStock/Getty Images

The motion passed with an 11-1 vote after members voted down two other options to either discontinue or continue the current recommendation of PCV13 for all immunocompetent adults aged 65 years and older. The current recommendation for PCV13 for adults aged 65 years and older has been in place since 2014.

The pneumococcal work group assessed indirect effects of the pediatric PCV vaccination on older adults prior to 2014 and since 2014, and what additional benefits might be expected if routine vaccination of older adults continued.

“Indirect effects have been observed in all age groups” said Almea Matanock, MD, of the CDC’s National Center for Immunization and Respiratory Diseases. Although there were no safety concerns, the public health impact of continued vaccination of adults was minimal.

Although PCV13 resulted in a 75% reduction in vaccine-type invasive pneumococcal disease and a 45% reduction in vaccine-type nonbacteremic pneumonia in 2014, the annual number needed to vaccinate to prevent a single case of outpatient pneumonia was 2,600, said Dr. Matanock.

Dr. Matanock presented key issues from the Evidence to Recommendations Framework for and against the recommendation for PCV13 in older adults. Work group comments in favor of continuing the recommendation for PCV13 in older adults included effective disease prevention and the potential negative impact on the importance of adult vaccines if the vaccine was no longer recommended. However, some work group members and committee members expressed concern about resource allocation and steering vaccines away from younger age groups in whom they have been more consistently effective.

Paul Hunter, MD, of the City of Milwaukee Health Department, voted against the shared clinical decision making, and instead favored discontinuing the recommendation for PCV13 for older adults. “I think clinicians need a clear message,” he said, adding that “the public health bang for the buck is with the kids.”

“I think there was a recognition that the population level benefit is minimal,” said work group chair Grace Lee, MD.

Although the work group recognized some benefit for older adults, the burden of disease for PCV-specific disease is low, compared with all-cause pneumonia, said Dr. Lee of Lucile Packard Children’s Hospital at Stanford, Calif. However, the recommendation for shared clinical decision making allows for potential insurance coverage of the vaccine for adults who decide after discussion with their health care provider that they would benefit.

“We are still unpacking this construct” of shared clinical decision making, which in this case applies to adults without immunocompromising conditions, and is more of a provider assessment than a risk assessment, she said.

The ACIP members had no financial conflicts to disclose.

The Food and Drug Administration has approved dupilumab (Dupixent) for the treatment of chronic rhinosinusitis accompanied by nasal polyps in adults.

FDA approval is based on results from a pair of studies involving 724 patients aged 18 years or older with chronic rhinosinusitis with nasal polyps who were symptomatic despite undergoing treatment with intranasal corticosteroids and who received either dupilumab or a placebo. Compared with the placebo group, patients receiving dupilumab had statistically significant reductions in nasal polyp size and nasal congestion; they also had an increased ability to smell and required less nasal polyp surgery and oral steroids.

The most commonly reported adverse events were injection-site reactions and eye and eyelid inflammation, which included redness, swelling, and itching. The drug can cause severe allergic reactions and eye problems, such as conjunctivitis or keratitis; patients should also not receive live vaccines while taking dupilumab.

“Nasal polyps can lead to loss of smell, and often patients require surgery to remove the polyps. Dupixent provides an important treatment option for patients whose nasal polyps are not adequately controlled with intranasal steroids. It also reduces the need for nasal polyp surgery and oral steroids,” said Sally Seymour, MD, director of the Division of Pulmonary, Allergy, and Rheumatology Products in the FDA’s Center for Drug Evaluation and Research.

Find the full press release on the FDA website.

lfranki@mdedge.com

The Food and Drug Administration has approved dupilumab (Dupixent) for the treatment of chronic rhinosinusitis accompanied by nasal polyps in adults.

FDA approval is based on results from a pair of studies involving 724 patients aged 18 years or older with chronic rhinosinusitis with nasal polyps who were symptomatic despite undergoing treatment with intranasal corticosteroids and who received either dupilumab or a placebo. Compared with the placebo group, patients receiving dupilumab had statistically significant reductions in nasal polyp size and nasal congestion; they also had an increased ability to smell and required less nasal polyp surgery and oral steroids.

The most commonly reported adverse events were injection-site reactions and eye and eyelid inflammation, which included redness, swelling, and itching. The drug can cause severe allergic reactions and eye problems, such as conjunctivitis or keratitis; patients should also not receive live vaccines while taking dupilumab.

“Nasal polyps can lead to loss of smell, and often patients require surgery to remove the polyps. Dupixent provides an important treatment option for patients whose nasal polyps are not adequately controlled with intranasal steroids. It also reduces the need for nasal polyp surgery and oral steroids,” said Sally Seymour, MD, director of the Division of Pulmonary, Allergy, and Rheumatology Products in the FDA’s Center for Drug Evaluation and Research.

Find the full press release on the FDA website.

lfranki@mdedge.com

The Food and Drug Administration has approved dupilumab (Dupixent) for the treatment of chronic rhinosinusitis accompanied by nasal polyps in adults.

FDA approval is based on results from a pair of studies involving 724 patients aged 18 years or older with chronic rhinosinusitis with nasal polyps who were symptomatic despite undergoing treatment with intranasal corticosteroids and who received either dupilumab or a placebo. Compared with the placebo group, patients receiving dupilumab had statistically significant reductions in nasal polyp size and nasal congestion; they also had an increased ability to smell and required less nasal polyp surgery and oral steroids.

The most commonly reported adverse events were injection-site reactions and eye and eyelid inflammation, which included redness, swelling, and itching. The drug can cause severe allergic reactions and eye problems, such as conjunctivitis or keratitis; patients should also not receive live vaccines while taking dupilumab.

“Nasal polyps can lead to loss of smell, and often patients require surgery to remove the polyps. Dupixent provides an important treatment option for patients whose nasal polyps are not adequately controlled with intranasal steroids. It also reduces the need for nasal polyp surgery and oral steroids,” said Sally Seymour, MD, director of the Division of Pulmonary, Allergy, and Rheumatology Products in the FDA’s Center for Drug Evaluation and Research.

Find the full press release on the FDA website.

lfranki@mdedge.com

MADRID – Tocilizumab (Actemra) preserved lung function in patients with early systemic sclerosis (SSc), according to a secondary endpoint analysis of the phase 3, double-blind, randomized, controlled focuSSced trial.

Vidyard Video

After 48 weeks, a significantly lower proportion of patients treated with tocilizumab than placebo experienced any decline in lung function from baseline (50.5% versus 70.3% (P = .015), as defined by the percentage increase in predicted forced vital capacity (%pFVC). When only patients with interstitial lung disease (ILD) were considered, the respective percentages were 51.7% and 75.5% (P = .003).

In SSc-ILD patients, a clinically meaningful decline of 10% or more of the %pFVC in lung function was seen in 24.5% given placebo but in just 8.6% of those treated with tocilizumab.

“ILD is a major complication of scleroderma; it has high morbidity and mortality ... and it’s largely irreversible,” Dinesh Khanna, MD, said at the European Congress of Rheumatology.

“In this day and age, when we treat ILD, we wait for a patient to develop clinical ILD,” added Dr. Khanna, director of the scleroderma program at the University of Michigan, Ann Arbor. Clinical ILD can be defined by symptoms, abnormal pulmonary function tests, and marked abnormalities on high resolution computed tomography (HRCT) scans. He indicated that if improving ILD was not possible, then the next best thing would be to stabilize the disease and ensure there was no worsening in lung function.

As yet, there are no disease-modifying treatments available to treat SSc but there are “ample data that interleukin-6 plays a very important role in the pathogenesis of scleroderma,” Dr. Khanna observed. Tocilizumab is a humanized monoclonal antibody against the interleukin-6 receptor.

Data from the phase 2 faSScinate trial showed initial promise for the drug in SSc where a numerical, but not statistically significant, improvement in skin thickening was seen, and the results had hinted at a possible benefit on lung function (Lancet. 2016 Jun 25;387:2630-40).

However, in the phase 3 focuSSced trial, there was no statistically significant difference in the change from baseline to week 48 modified Rodnan skin score (mRSS) between tocilizumab and placebo, which was the primary endpoint. The least square mean change in mRSS was –6.14 for tocilizumab and –4.41 for placebo (P = .0983).

A total of 205 patients with SSc were studied and randomized, 1:1 in a double-blind fashion, to receive either a once-weekly, subcutaneous dose of 162 mg tocilizumab or a weekly subcutaneous placebo injection for 48 weeks.

For inclusion in the study, patients had to have SSc that met American College of Rheumatology and European League Against Rheumatism (EULAR) criteria and be diagnosed less than 60 months previously. Patients had to have an mRSS of 10-35 units and active disease with one or more of the following: C-reactive protein of 6 mg/L or higher; erythrocyte sedimentation rate of 28 mm/h or higher; and platelet count of330 x 10⁹ L.


“What was astonishing in the trial was that every patient had HRCT at baseline and at the end of the study,” Dr. Khanna reported. These scans showed that 64% of patients had evidence of ILD at baseline and that those treated with tocilizumab had less evidence of fibrosis at week 48 versus placebo, indicating a stabilization rather than worsening of disease.

A time to treatment failure analysis also favored tocilizumab over placebo, but there were no significant changes in patient-reported outcomes.

Dr. Khanna’s slides stated that “given that the primary endpoint for mRSS was not met, all other P values are presented for information purposes only and cannot be considered statistically significant despite the strength of the evidence.” During the Q&A after his presentation, he noted that it was unlikely that the study’s sponsors (Roche/Genentech) will now pursue a license for tocilizumab in SSc.

Nevertheless, Dr. Khanna concluded, “we have the opportunity, based on these data, to treat these patients early on, where you can preserve the lung function, which is a paradigm shift versus waiting for the lung function to decline, become clinically meaningful, significant, and then treat this patient population.”

Roche/Genentech sponsored the study. Dr. Khanna acts as a consultant to Roche/Genentech and eight other pharmaceutical companies. He owns stock in Eicos Sciences.

SOURCE: Khanna D et al. Ann Rheum Dis. Jun 2019;78(Suppl 2):202-3. Abstract OP0245, doi: 10.1136/annrheumdis-2019-eular.2120

MADRID – Tocilizumab (Actemra) preserved lung function in patients with early systemic sclerosis (SSc), according to a secondary endpoint analysis of the phase 3, double-blind, randomized, controlled focuSSced trial.

Vidyard Video

After 48 weeks, a significantly lower proportion of patients treated with tocilizumab than placebo experienced any decline in lung function from baseline (50.5% versus 70.3% (P = .015), as defined by the percentage increase in predicted forced vital capacity (%pFVC). When only patients with interstitial lung disease (ILD) were considered, the respective percentages were 51.7% and 75.5% (P = .003).

In SSc-ILD patients, a clinically meaningful decline of 10% or more of the %pFVC in lung function was seen in 24.5% given placebo but in just 8.6% of those treated with tocilizumab.

“ILD is a major complication of scleroderma; it has high morbidity and mortality ... and it’s largely irreversible,” Dinesh Khanna, MD, said at the European Congress of Rheumatology.

“In this day and age, when we treat ILD, we wait for a patient to develop clinical ILD,” added Dr. Khanna, director of the scleroderma program at the University of Michigan, Ann Arbor. Clinical ILD can be defined by symptoms, abnormal pulmonary function tests, and marked abnormalities on high resolution computed tomography (HRCT) scans. He indicated that if improving ILD was not possible, then the next best thing would be to stabilize the disease and ensure there was no worsening in lung function.

As yet, there are no disease-modifying treatments available to treat SSc but there are “ample data that interleukin-6 plays a very important role in the pathogenesis of scleroderma,” Dr. Khanna observed. Tocilizumab is a humanized monoclonal antibody against the interleukin-6 receptor.

Data from the phase 2 faSScinate trial showed initial promise for the drug in SSc where a numerical, but not statistically significant, improvement in skin thickening was seen, and the results had hinted at a possible benefit on lung function (Lancet. 2016 Jun 25;387:2630-40).

However, in the phase 3 focuSSced trial, there was no statistically significant difference in the change from baseline to week 48 modified Rodnan skin score (mRSS) between tocilizumab and placebo, which was the primary endpoint. The least square mean change in mRSS was –6.14 for tocilizumab and –4.41 for placebo (P = .0983).

A total of 205 patients with SSc were studied and randomized, 1:1 in a double-blind fashion, to receive either a once-weekly, subcutaneous dose of 162 mg tocilizumab or a weekly subcutaneous placebo injection for 48 weeks.

For inclusion in the study, patients had to have SSc that met American College of Rheumatology and European League Against Rheumatism (EULAR) criteria and be diagnosed less than 60 months previously. Patients had to have an mRSS of 10-35 units and active disease with one or more of the following: C-reactive protein of 6 mg/L or higher; erythrocyte sedimentation rate of 28 mm/h or higher; and platelet count of330 x 10⁹ L.


“What was astonishing in the trial was that every patient had HRCT at baseline and at the end of the study,” Dr. Khanna reported. These scans showed that 64% of patients had evidence of ILD at baseline and that those treated with tocilizumab had less evidence of fibrosis at week 48 versus placebo, indicating a stabilization rather than worsening of disease.

A time to treatment failure analysis also favored tocilizumab over placebo, but there were no significant changes in patient-reported outcomes.

Dr. Khanna’s slides stated that “given that the primary endpoint for mRSS was not met, all other P values are presented for information purposes only and cannot be considered statistically significant despite the strength of the evidence.” During the Q&A after his presentation, he noted that it was unlikely that the study’s sponsors (Roche/Genentech) will now pursue a license for tocilizumab in SSc.

Nevertheless, Dr. Khanna concluded, “we have the opportunity, based on these data, to treat these patients early on, where you can preserve the lung function, which is a paradigm shift versus waiting for the lung function to decline, become clinically meaningful, significant, and then treat this patient population.”

Roche/Genentech sponsored the study. Dr. Khanna acts as a consultant to Roche/Genentech and eight other pharmaceutical companies. He owns stock in Eicos Sciences.

SOURCE: Khanna D et al. Ann Rheum Dis. Jun 2019;78(Suppl 2):202-3. Abstract OP0245, doi: 10.1136/annrheumdis-2019-eular.2120

MADRID – Tocilizumab (Actemra) preserved lung function in patients with early systemic sclerosis (SSc), according to a secondary endpoint analysis of the phase 3, double-blind, randomized, controlled focuSSced trial.

Vidyard Video

After 48 weeks, a significantly lower proportion of patients treated with tocilizumab than placebo experienced any decline in lung function from baseline (50.5% versus 70.3% (P = .015), as defined by the percentage increase in predicted forced vital capacity (%pFVC). When only patients with interstitial lung disease (ILD) were considered, the respective percentages were 51.7% and 75.5% (P = .003).

In SSc-ILD patients, a clinically meaningful decline of 10% or more of the %pFVC in lung function was seen in 24.5% given placebo but in just 8.6% of those treated with tocilizumab.

“ILD is a major complication of scleroderma; it has high morbidity and mortality ... and it’s largely irreversible,” Dinesh Khanna, MD, said at the European Congress of Rheumatology.

“In this day and age, when we treat ILD, we wait for a patient to develop clinical ILD,” added Dr. Khanna, director of the scleroderma program at the University of Michigan, Ann Arbor. Clinical ILD can be defined by symptoms, abnormal pulmonary function tests, and marked abnormalities on high resolution computed tomography (HRCT) scans. He indicated that if improving ILD was not possible, then the next best thing would be to stabilize the disease and ensure there was no worsening in lung function.

As yet, there are no disease-modifying treatments available to treat SSc but there are “ample data that interleukin-6 plays a very important role in the pathogenesis of scleroderma,” Dr. Khanna observed. Tocilizumab is a humanized monoclonal antibody against the interleukin-6 receptor.

Data from the phase 2 faSScinate trial showed initial promise for the drug in SSc where a numerical, but not statistically significant, improvement in skin thickening was seen, and the results had hinted at a possible benefit on lung function (Lancet. 2016 Jun 25;387:2630-40).

However, in the phase 3 focuSSced trial, there was no statistically significant difference in the change from baseline to week 48 modified Rodnan skin score (mRSS) between tocilizumab and placebo, which was the primary endpoint. The least square mean change in mRSS was –6.14 for tocilizumab and –4.41 for placebo (P = .0983).

A total of 205 patients with SSc were studied and randomized, 1:1 in a double-blind fashion, to receive either a once-weekly, subcutaneous dose of 162 mg tocilizumab or a weekly subcutaneous placebo injection for 48 weeks.

For inclusion in the study, patients had to have SSc that met American College of Rheumatology and European League Against Rheumatism (EULAR) criteria and be diagnosed less than 60 months previously. Patients had to have an mRSS of 10-35 units and active disease with one or more of the following: C-reactive protein of 6 mg/L or higher; erythrocyte sedimentation rate of 28 mm/h or higher; and platelet count of330 x 10⁹ L.


“What was astonishing in the trial was that every patient had HRCT at baseline and at the end of the study,” Dr. Khanna reported. These scans showed that 64% of patients had evidence of ILD at baseline and that those treated with tocilizumab had less evidence of fibrosis at week 48 versus placebo, indicating a stabilization rather than worsening of disease.

A time to treatment failure analysis also favored tocilizumab over placebo, but there were no significant changes in patient-reported outcomes.

Dr. Khanna’s slides stated that “given that the primary endpoint for mRSS was not met, all other P values are presented for information purposes only and cannot be considered statistically significant despite the strength of the evidence.” During the Q&A after his presentation, he noted that it was unlikely that the study’s sponsors (Roche/Genentech) will now pursue a license for tocilizumab in SSc.

Nevertheless, Dr. Khanna concluded, “we have the opportunity, based on these data, to treat these patients early on, where you can preserve the lung function, which is a paradigm shift versus waiting for the lung function to decline, become clinically meaningful, significant, and then treat this patient population.”

Roche/Genentech sponsored the study. Dr. Khanna acts as a consultant to Roche/Genentech and eight other pharmaceutical companies. He owns stock in Eicos Sciences.

SOURCE: Khanna D et al. Ann Rheum Dis. Jun 2019;78(Suppl 2):202-3. Abstract OP0245, doi: 10.1136/annrheumdis-2019-eular.2120

After 20 years on the rise, new cases of diagnosed diabetes mellitus (DM) in the US have declined by 35%, from 1.7 million in 2008 to 1.3 million in 2017, according to CDC researchers. Not only that: The number of people living with diagnosed DM in the US has remained stable for the past 8 years.

The findings represent the longest decline in new DM cases and the longest sustained plateau in existing cases. Between 1990 and 2009, the number of people living with diagnosed diabetes (DD) rose 4.4% per year, peaked at 8.2 per 100 adults, then leveled off at 8 per 100 in 2017. The trends were similar across age groups, racial and ethnic groups, and genders.

In part, the plateau may be due to the fact that people with DM are living longer, the researchers suggest, pointing to recent reports of a decline in cardiovascular and all-cause mortality in adults with DD.

But maybe the work to “stem the tide of type 2 diabetes” is finally having an effect, says Ann Albright, PhD, director of the CDC Division of Diabetes Translation. She stresses the importance of “putting science-proven programs into action,” citing the National Diabetes Prevention Program as a prime example. But she adds, “We must also increase access to affordable, healthier foods, and safe places to be active.”

The news about the decrease in new diabetes cases comes simultaneously with findings from the Restoring Insulin Secretion (RISE) Adult and Pediatric Medication Studies, which found that type 2 diabetes mellitus (T2DM) progression slows during treatment but resumes after treatment stops.

The research, funded by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), was aimed at finding ways to preserve β-cell function. The adult study randomly assigned participants aged 20 to 65 years to receive long-acting insulin (glargine) for 3 months, followed by metformin for 9 months; liraglutide with metformin for 12 months; metformin alone for 12 months; or placebo. Participants’ β-cell function and blood glucose control improved on the treatments, with those in the liraglutide/metformin group showing the most improvement. But the improvements did not persist after treatment ended. “[T]reatment options were equally effective while people were actively on them,” says study chair Dr. Steven Kahn, from the VA Puget Sound Health Care System. “But people need to stay on treatment to maintain the benefits.”

The youth study (participants aged 10-19 years) study compared 3 months of insulin glargine, followed by metformin for 9 months, to metformin alone for 12 months. (Insulin glargine and metformin are the only FDA-approved drugs for young people with T2D )  β-cell function declined in the 2 pediatric treatment groups and even worsened after treatment ended. The studies support earlier evidence that T2DM affects young people differently and more aggressively than it does in adults, NIDDK Director Dr. Griffin Rodgers says.

Other research news is brighter for people at risk for type 1 diabetes mellitus (T1DM): An NIH-funded study found that treatment with teplizumab, an anti-CD3 monoclonal antibody, delayed clinical T1DM by ≥ 2 years.

Previous research had found that teplizumab slows the loss of β cells in people with recent-onset clinical T1DM, but the drug had not been tested in people without clinical disease. The researchers wanted to see whether early intervention would have a benefit for people at high risk. They compared a 14-day course of teplizumab with placebo in 76 participants aged 8 to 49 years who were relatives of people with T1DM, had at ≥ 2 types of DM-related autoantibodies, and had abnormal glucose tolerance.

During the trial, 72% of people on placebo developed clinical DM compared with 43% of those in the treatment group. The median time for the control participants to develop DM was just over 24 months vs 48 months in the teplizumab group. The effects of the drug were greatest in the first year after it was given, when 41% of the participants—mainly in the placebo group—developed clinical diabetes.

At-risk children and adolescents are known to progress to T1DM faster than adults, the researchers note. They say faster progression is associated with a highly active immune system, which may explain the impact of immune system-modulating drugs like teplizumab.

The study “illustrates how decades of research on the biology of T1D can lead to promising treatments that have a real impact on people’s lives,” NIDDK Director Rodgers says.

But the T1DM and T2DM studies, although highlighting areas of effectiveness, also underscore the continued need for new approaches to prevent and treat DM in young people.

Although the drop in new cases of T2DM are still unclear, the CDC researchers suggest that they are driven in part by increased awareness of DM prevention, changes in diet, changes in physical activity, and changes in diagnostic and screening practices. In other words, prevention also remains an urgent need.

After 20 years on the rise, new cases of diagnosed diabetes mellitus (DM) in the US have declined by 35%, from 1.7 million in 2008 to 1.3 million in 2017, according to CDC researchers. Not only that: The number of people living with diagnosed DM in the US has remained stable for the past 8 years.

The findings represent the longest decline in new DM cases and the longest sustained plateau in existing cases. Between 1990 and 2009, the number of people living with diagnosed diabetes (DD) rose 4.4% per year, peaked at 8.2 per 100 adults, then leveled off at 8 per 100 in 2017. The trends were similar across age groups, racial and ethnic groups, and genders.

In part, the plateau may be due to the fact that people with DM are living longer, the researchers suggest, pointing to recent reports of a decline in cardiovascular and all-cause mortality in adults with DD.

But maybe the work to “stem the tide of type 2 diabetes” is finally having an effect, says Ann Albright, PhD, director of the CDC Division of Diabetes Translation. She stresses the importance of “putting science-proven programs into action,” citing the National Diabetes Prevention Program as a prime example. But she adds, “We must also increase access to affordable, healthier foods, and safe places to be active.”

The news about the decrease in new diabetes cases comes simultaneously with findings from the Restoring Insulin Secretion (RISE) Adult and Pediatric Medication Studies, which found that type 2 diabetes mellitus (T2DM) progression slows during treatment but resumes after treatment stops.

The research, funded by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), was aimed at finding ways to preserve β-cell function. The adult study randomly assigned participants aged 20 to 65 years to receive long-acting insulin (glargine) for 3 months, followed by metformin for 9 months; liraglutide with metformin for 12 months; metformin alone for 12 months; or placebo. Participants’ β-cell function and blood glucose control improved on the treatments, with those in the liraglutide/metformin group showing the most improvement. But the improvements did not persist after treatment ended. “[T]reatment options were equally effective while people were actively on them,” says study chair Dr. Steven Kahn, from the VA Puget Sound Health Care System. “But people need to stay on treatment to maintain the benefits.”

The youth study (participants aged 10-19 years) study compared 3 months of insulin glargine, followed by metformin for 9 months, to metformin alone for 12 months. (Insulin glargine and metformin are the only FDA-approved drugs for young people with T2D )  β-cell function declined in the 2 pediatric treatment groups and even worsened after treatment ended. The studies support earlier evidence that T2DM affects young people differently and more aggressively than it does in adults, NIDDK Director Dr. Griffin Rodgers says.

Other research news is brighter for people at risk for type 1 diabetes mellitus (T1DM): An NIH-funded study found that treatment with teplizumab, an anti-CD3 monoclonal antibody, delayed clinical T1DM by ≥ 2 years.

Previous research had found that teplizumab slows the loss of β cells in people with recent-onset clinical T1DM, but the drug had not been tested in people without clinical disease. The researchers wanted to see whether early intervention would have a benefit for people at high risk. They compared a 14-day course of teplizumab with placebo in 76 participants aged 8 to 49 years who were relatives of people with T1DM, had at ≥ 2 types of DM-related autoantibodies, and had abnormal glucose tolerance.

During the trial, 72% of people on placebo developed clinical DM compared with 43% of those in the treatment group. The median time for the control participants to develop DM was just over 24 months vs 48 months in the teplizumab group. The effects of the drug were greatest in the first year after it was given, when 41% of the participants—mainly in the placebo group—developed clinical diabetes.

At-risk children and adolescents are known to progress to T1DM faster than adults, the researchers note. They say faster progression is associated with a highly active immune system, which may explain the impact of immune system-modulating drugs like teplizumab.

The study “illustrates how decades of research on the biology of T1D can lead to promising treatments that have a real impact on people’s lives,” NIDDK Director Rodgers says.

But the T1DM and T2DM studies, although highlighting areas of effectiveness, also underscore the continued need for new approaches to prevent and treat DM in young people.

Although the drop in new cases of T2DM are still unclear, the CDC researchers suggest that they are driven in part by increased awareness of DM prevention, changes in diet, changes in physical activity, and changes in diagnostic and screening practices. In other words, prevention also remains an urgent need.

After 20 years on the rise, new cases of diagnosed diabetes mellitus (DM) in the US have declined by 35%, from 1.7 million in 2008 to 1.3 million in 2017, according to CDC researchers. Not only that: The number of people living with diagnosed DM in the US has remained stable for the past 8 years.

The findings represent the longest decline in new DM cases and the longest sustained plateau in existing cases. Between 1990 and 2009, the number of people living with diagnosed diabetes (DD) rose 4.4% per year, peaked at 8.2 per 100 adults, then leveled off at 8 per 100 in 2017. The trends were similar across age groups, racial and ethnic groups, and genders.

In part, the plateau may be due to the fact that people with DM are living longer, the researchers suggest, pointing to recent reports of a decline in cardiovascular and all-cause mortality in adults with DD.

But maybe the work to “stem the tide of type 2 diabetes” is finally having an effect, says Ann Albright, PhD, director of the CDC Division of Diabetes Translation. She stresses the importance of “putting science-proven programs into action,” citing the National Diabetes Prevention Program as a prime example. But she adds, “We must also increase access to affordable, healthier foods, and safe places to be active.”

The news about the decrease in new diabetes cases comes simultaneously with findings from the Restoring Insulin Secretion (RISE) Adult and Pediatric Medication Studies, which found that type 2 diabetes mellitus (T2DM) progression slows during treatment but resumes after treatment stops.

The research, funded by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), was aimed at finding ways to preserve β-cell function. The adult study randomly assigned participants aged 20 to 65 years to receive long-acting insulin (glargine) for 3 months, followed by metformin for 9 months; liraglutide with metformin for 12 months; metformin alone for 12 months; or placebo. Participants’ β-cell function and blood glucose control improved on the treatments, with those in the liraglutide/metformin group showing the most improvement. But the improvements did not persist after treatment ended. “[T]reatment options were equally effective while people were actively on them,” says study chair Dr. Steven Kahn, from the VA Puget Sound Health Care System. “But people need to stay on treatment to maintain the benefits.”

The youth study (participants aged 10-19 years) study compared 3 months of insulin glargine, followed by metformin for 9 months, to metformin alone for 12 months. (Insulin glargine and metformin are the only FDA-approved drugs for young people with T2D )  β-cell function declined in the 2 pediatric treatment groups and even worsened after treatment ended. The studies support earlier evidence that T2DM affects young people differently and more aggressively than it does in adults, NIDDK Director Dr. Griffin Rodgers says.

Other research news is brighter for people at risk for type 1 diabetes mellitus (T1DM): An NIH-funded study found that treatment with teplizumab, an anti-CD3 monoclonal antibody, delayed clinical T1DM by ≥ 2 years.

Previous research had found that teplizumab slows the loss of β cells in people with recent-onset clinical T1DM, but the drug had not been tested in people without clinical disease. The researchers wanted to see whether early intervention would have a benefit for people at high risk. They compared a 14-day course of teplizumab with placebo in 76 participants aged 8 to 49 years who were relatives of people with T1DM, had at ≥ 2 types of DM-related autoantibodies, and had abnormal glucose tolerance.

During the trial, 72% of people on placebo developed clinical DM compared with 43% of those in the treatment group. The median time for the control participants to develop DM was just over 24 months vs 48 months in the teplizumab group. The effects of the drug were greatest in the first year after it was given, when 41% of the participants—mainly in the placebo group—developed clinical diabetes.

At-risk children and adolescents are known to progress to T1DM faster than adults, the researchers note. They say faster progression is associated with a highly active immune system, which may explain the impact of immune system-modulating drugs like teplizumab.

The study “illustrates how decades of research on the biology of T1D can lead to promising treatments that have a real impact on people’s lives,” NIDDK Director Rodgers says.

But the T1DM and T2DM studies, although highlighting areas of effectiveness, also underscore the continued need for new approaches to prevent and treat DM in young people.

Although the drop in new cases of T2DM are still unclear, the CDC researchers suggest that they are driven in part by increased awareness of DM prevention, changes in diet, changes in physical activity, and changes in diagnostic and screening practices. In other words, prevention also remains an urgent need.

Although earlier research may suggest otherwise, traditional Medicare may actually do a better job of lowering the risk of hospital readmissions than Medicare Advantage, new research suggests.

Copyright Kimberly Pack/Thinkstock

Researchers used what they described as “a novel data linkage” comparing 30-day readmission rates after hospitalization for three major conditions in the Hospital Readmissions Reduction Program for patients using traditional Medicare versus Medicare Advantage. Those conditions included acute MI, heart failure, and pneumonia.

“Our results contrast with those of previous studies that have reported lower or statistically similar readmission rates for Medicare Advantage beneficiaries,” Orestis A. Panagiotou, MD, of Brown University, Providence, R.I., and colleagues wrote in a research report published in Annals of Internal Medicine.

In this retrospective cohort study, the researchers linked data from 2011 to 2014 from the Medicare Provider Analysis and Review (MedPAR) file to the Healthcare Effectiveness Data and Information Set (HEDIS).

The novel linkage found that HEDIS data underreported hospital admissions for acute MI, heart failure, and pneumonia, the researchers stated. “Plans incorrectly excluded hospitalizations that should have qualified for the readmission measure, and readmission rates were substantially higher among incorrectly excluded hospitalizations.”

Despite this, in analyses using the linkage of HEDIS and MedPAR, “Medicare Advantage beneficiaries had higher 30-day risk-adjusted readmission rates after [acute MI, heart failure, and pneumonia] than did traditional Medicare beneficiaries,” the investigators noted.

Patients in Medicare Advantage had lower unadjusted readmission rates compared with those in traditional Medicare (16.6% vs. 17.1% for acute MI; 21.4% vs. 21.7% for heart failure; and 16.3% vs. 16.4% for pneumonia). After standardization, Medicare Advantage patients had higher readmission rates, compared with those in traditional Medicare (17.2% vs. 16.9% for acute MI; 21.7% vs. 21.4% for heart failure; and 16.5% vs. 16.0% for pneumonia).

The study authors added that, while unadjusted readmission rates were higher for traditional Medicare beneficiaries, “the direction of the difference reversed after standardization. This occurred because Medicare Advantage beneficiaries have, on average, a lower expected readmission risk [that is, they are ‘healthier’].” Prior studies have documented that Medicare Advantage plans enroll beneficiaries with fewer comorbid conditions and that high-cost beneficiaries switch out of Medicare Advantage and into traditional Medicare.

The researchers suggested four reasons for the differences between the results in this study versus others that compared patients using Medicare with those using Medicare Advantage. These were that the new study included a more comprehensive data set, analyses with comorbid conditions “from a well-validated model applied by CMS [Centers for Medicare & Medicaid Services],” national data focused on three conditions included in the Hospital Readmissions Reduction Program, and patients discharged to places other than skilled nursing facilities and inpatient rehabilitation facilities.

Authors of an accompanying editorial called for caution to be used in interpreting Medicare Advantage enrollment as causing an increased readmission risk.

“[The] results are sensitive to adjustment for case mix,” wrote Peter Huckfeldt, PhD, of the University of Minnesota, Minneapolis, and Neeraj Sood, PhD, of the University of Southern California, Los Angeles, in the editorial published in Annals of Internal Medicine (2019 June 25. doi:10.7326/M19-1599) “Using diagnosis codes on hospital claims for case-mix adjustments may be increasingly perilous. ... To our knowledge, there is no recent evidence comparing the intensity of diagnostic coding between clinically similar [traditional Medicare] and [Medicare Advantage] hospital admissions, but if [traditional Medicare] enrollees were coded more intensively than [Medicare Advantage] enrollees, this could lead to [traditional Medicare] enrollees having lower risk-adjusted readmission rares due to coding practices.”

The editorialists added that using a cross-sectional comparison of Medicare Advantage and traditional Medicare patients is concerning because a “key challenge in estimating the effect of [Medicare Advantage] is that enrollment is voluntary,” which can lead to a number of analytical concerns.

The researchers concluded that their findings “are concerning because CMS uses HEDIS performance to construct composite quality ratings and assign payment bonuses to Medicare Advantage plans.

“Our study suggests a need for improved monitoring of the accuracy of HEDIS data,” they noted.

The National Institute on Aging provided the primary funding for this study. A number of the authors received grants from the National Institutes of Health during the conduct of the study. No other relevant disclosures were reported.

gtwachtman@mdedge.com

SOURCE: Panagiotou OA et al. Ann Intern Med. 2019 Jun 25. doi: 10.7326/M18-1795.

Although earlier research may suggest otherwise, traditional Medicare may actually do a better job of lowering the risk of hospital readmissions than Medicare Advantage, new research suggests.

Copyright Kimberly Pack/Thinkstock

Researchers used what they described as “a novel data linkage” comparing 30-day readmission rates after hospitalization for three major conditions in the Hospital Readmissions Reduction Program for patients using traditional Medicare versus Medicare Advantage. Those conditions included acute MI, heart failure, and pneumonia.

“Our results contrast with those of previous studies that have reported lower or statistically similar readmission rates for Medicare Advantage beneficiaries,” Orestis A. Panagiotou, MD, of Brown University, Providence, R.I., and colleagues wrote in a research report published in Annals of Internal Medicine.

In this retrospective cohort study, the researchers linked data from 2011 to 2014 from the Medicare Provider Analysis and Review (MedPAR) file to the Healthcare Effectiveness Data and Information Set (HEDIS).

The novel linkage found that HEDIS data underreported hospital admissions for acute MI, heart failure, and pneumonia, the researchers stated. “Plans incorrectly excluded hospitalizations that should have qualified for the readmission measure, and readmission rates were substantially higher among incorrectly excluded hospitalizations.”

Despite this, in analyses using the linkage of HEDIS and MedPAR, “Medicare Advantage beneficiaries had higher 30-day risk-adjusted readmission rates after [acute MI, heart failure, and pneumonia] than did traditional Medicare beneficiaries,” the investigators noted.

Patients in Medicare Advantage had lower unadjusted readmission rates compared with those in traditional Medicare (16.6% vs. 17.1% for acute MI; 21.4% vs. 21.7% for heart failure; and 16.3% vs. 16.4% for pneumonia). After standardization, Medicare Advantage patients had higher readmission rates, compared with those in traditional Medicare (17.2% vs. 16.9% for acute MI; 21.7% vs. 21.4% for heart failure; and 16.5% vs. 16.0% for pneumonia).

The study authors added that, while unadjusted readmission rates were higher for traditional Medicare beneficiaries, “the direction of the difference reversed after standardization. This occurred because Medicare Advantage beneficiaries have, on average, a lower expected readmission risk [that is, they are ‘healthier’].” Prior studies have documented that Medicare Advantage plans enroll beneficiaries with fewer comorbid conditions and that high-cost beneficiaries switch out of Medicare Advantage and into traditional Medicare.

The researchers suggested four reasons for the differences between the results in this study versus others that compared patients using Medicare with those using Medicare Advantage. These were that the new study included a more comprehensive data set, analyses with comorbid conditions “from a well-validated model applied by CMS [Centers for Medicare & Medicaid Services],” national data focused on three conditions included in the Hospital Readmissions Reduction Program, and patients discharged to places other than skilled nursing facilities and inpatient rehabilitation facilities.

Authors of an accompanying editorial called for caution to be used in interpreting Medicare Advantage enrollment as causing an increased readmission risk.

“[The] results are sensitive to adjustment for case mix,” wrote Peter Huckfeldt, PhD, of the University of Minnesota, Minneapolis, and Neeraj Sood, PhD, of the University of Southern California, Los Angeles, in the editorial published in Annals of Internal Medicine (2019 June 25. doi:10.7326/M19-1599) “Using diagnosis codes on hospital claims for case-mix adjustments may be increasingly perilous. ... To our knowledge, there is no recent evidence comparing the intensity of diagnostic coding between clinically similar [traditional Medicare] and [Medicare Advantage] hospital admissions, but if [traditional Medicare] enrollees were coded more intensively than [Medicare Advantage] enrollees, this could lead to [traditional Medicare] enrollees having lower risk-adjusted readmission rares due to coding practices.”

The editorialists added that using a cross-sectional comparison of Medicare Advantage and traditional Medicare patients is concerning because a “key challenge in estimating the effect of [Medicare Advantage] is that enrollment is voluntary,” which can lead to a number of analytical concerns.

The researchers concluded that their findings “are concerning because CMS uses HEDIS performance to construct composite quality ratings and assign payment bonuses to Medicare Advantage plans.

“Our study suggests a need for improved monitoring of the accuracy of HEDIS data,” they noted.

The National Institute on Aging provided the primary funding for this study. A number of the authors received grants from the National Institutes of Health during the conduct of the study. No other relevant disclosures were reported.

gtwachtman@mdedge.com

SOURCE: Panagiotou OA et al. Ann Intern Med. 2019 Jun 25. doi: 10.7326/M18-1795.

Although earlier research may suggest otherwise, traditional Medicare may actually do a better job of lowering the risk of hospital readmissions than Medicare Advantage, new research suggests.

Copyright Kimberly Pack/Thinkstock

Researchers used what they described as “a novel data linkage” comparing 30-day readmission rates after hospitalization for three major conditions in the Hospital Readmissions Reduction Program for patients using traditional Medicare versus Medicare Advantage. Those conditions included acute MI, heart failure, and pneumonia.

“Our results contrast with those of previous studies that have reported lower or statistically similar readmission rates for Medicare Advantage beneficiaries,” Orestis A. Panagiotou, MD, of Brown University, Providence, R.I., and colleagues wrote in a research report published in Annals of Internal Medicine.

In this retrospective cohort study, the researchers linked data from 2011 to 2014 from the Medicare Provider Analysis and Review (MedPAR) file to the Healthcare Effectiveness Data and Information Set (HEDIS).

The novel linkage found that HEDIS data underreported hospital admissions for acute MI, heart failure, and pneumonia, the researchers stated. “Plans incorrectly excluded hospitalizations that should have qualified for the readmission measure, and readmission rates were substantially higher among incorrectly excluded hospitalizations.”

Despite this, in analyses using the linkage of HEDIS and MedPAR, “Medicare Advantage beneficiaries had higher 30-day risk-adjusted readmission rates after [acute MI, heart failure, and pneumonia] than did traditional Medicare beneficiaries,” the investigators noted.

Patients in Medicare Advantage had lower unadjusted readmission rates compared with those in traditional Medicare (16.6% vs. 17.1% for acute MI; 21.4% vs. 21.7% for heart failure; and 16.3% vs. 16.4% for pneumonia). After standardization, Medicare Advantage patients had higher readmission rates, compared with those in traditional Medicare (17.2% vs. 16.9% for acute MI; 21.7% vs. 21.4% for heart failure; and 16.5% vs. 16.0% for pneumonia).

The study authors added that, while unadjusted readmission rates were higher for traditional Medicare beneficiaries, “the direction of the difference reversed after standardization. This occurred because Medicare Advantage beneficiaries have, on average, a lower expected readmission risk [that is, they are ‘healthier’].” Prior studies have documented that Medicare Advantage plans enroll beneficiaries with fewer comorbid conditions and that high-cost beneficiaries switch out of Medicare Advantage and into traditional Medicare.

The researchers suggested four reasons for the differences between the results in this study versus others that compared patients using Medicare with those using Medicare Advantage. These were that the new study included a more comprehensive data set, analyses with comorbid conditions “from a well-validated model applied by CMS [Centers for Medicare & Medicaid Services],” national data focused on three conditions included in the Hospital Readmissions Reduction Program, and patients discharged to places other than skilled nursing facilities and inpatient rehabilitation facilities.

Authors of an accompanying editorial called for caution to be used in interpreting Medicare Advantage enrollment as causing an increased readmission risk.

“[The] results are sensitive to adjustment for case mix,” wrote Peter Huckfeldt, PhD, of the University of Minnesota, Minneapolis, and Neeraj Sood, PhD, of the University of Southern California, Los Angeles, in the editorial published in Annals of Internal Medicine (2019 June 25. doi:10.7326/M19-1599) “Using diagnosis codes on hospital claims for case-mix adjustments may be increasingly perilous. ... To our knowledge, there is no recent evidence comparing the intensity of diagnostic coding between clinically similar [traditional Medicare] and [Medicare Advantage] hospital admissions, but if [traditional Medicare] enrollees were coded more intensively than [Medicare Advantage] enrollees, this could lead to [traditional Medicare] enrollees having lower risk-adjusted readmission rares due to coding practices.”

The editorialists added that using a cross-sectional comparison of Medicare Advantage and traditional Medicare patients is concerning because a “key challenge in estimating the effect of [Medicare Advantage] is that enrollment is voluntary,” which can lead to a number of analytical concerns.

The researchers concluded that their findings “are concerning because CMS uses HEDIS performance to construct composite quality ratings and assign payment bonuses to Medicare Advantage plans.

“Our study suggests a need for improved monitoring of the accuracy of HEDIS data,” they noted.

The National Institute on Aging provided the primary funding for this study. A number of the authors received grants from the National Institutes of Health during the conduct of the study. No other relevant disclosures were reported.

gtwachtman@mdedge.com

SOURCE: Panagiotou OA et al. Ann Intern Med. 2019 Jun 25. doi: 10.7326/M18-1795.

A study found that only 2% of children hospitalized with community-acquired pneumonia (CAP) actually had any causative pathogen in their blood culture results, despite national guidelines that recommend blood cultures for all children hospitalized with moderate to severe CAP.

CDC/Dr. Mike Miller

The guidelines are the 2011 guidelines for managing CAP published by the Pediatric Infectious Diseases Society (PIDS) and the Infectious Diseases Society of America (IDSA) (Clin Infect Dis. 2011 Oct;53[7]:617-30).

Cristin O. Fritz, MD, of the Children’s Hospital of Colorado, Aurora, and associates conducted a data analysis of the EPIC (Etiology of Pneumonia in the Community) study to estimate prevalence, risk factors, and clinical outcomes in children hospitalized with bacteremic CAP and to evaluate the relationship between positive blood culture results, empirical antibiotics, and changes in antibiotic treatment regimens.

Data were collected at two Tennessee hospitals and one Utah hospital during Jan. 1, 2010–June 30, 2012. Of the 2,358 children with CAP enrolled in the study, 2,143 (91%) with blood cultures were included in Dr. Fritz’s analysis. Of the 53 patients presenting with positive blood culture results, 46 (2%; 95% confidence interval: 1.6%-2.9%) were identified as having bacteremia. Half of all cases observed were caused by Streptococcus pneumoniae, with Staphylococcus aureus and Streptococcus pyogenes noted less frequently, according to the study published in Pediatrics.

A previous meta-analysis of smaller studies also found that children with CAP rarely had positive blood culture results, a pooled prevalence of 5% (Pediatr Infect Dis J. 2013;32[7]:736-40). Although it is believed that positive blood culture results are key to narrowing the choice of antibiotic and predicting treatment outcomes, the literature – to date – reveals a paucity of data supporting this assumption.

Overall, children in the study presenting with bacteremia experienced more severe clinical outcomes, including longer length of stay, greater likelihood of ICU admission, and invasive mechanical ventilation and/or shock. The authors also observed that bacteremia was less likely to be detected in children given antibiotics after admission but before cultures were obtained (0.8% vs 3%; P = .021). Pleural effusion detected with chest radiograph also consistently indicated bacteremic pneumonia, an observation made within this and other similar studies.

Also of note in detection is the biomarker procalcitonin, which is typically present with bacterial disease. Dr. Fritz and colleagues stressed that because the procalcitonin rate was higher in patients presenting with bacteremia, “this information could influence decisions around culturing if results are rapidly available.” Risk-stratification tools also might serve a valuable purpose in ferreting out those patients presenting with moderate to severe pneumonia most at increased risk for bacterial CAP.

Compared with other studies reporting prevalence ranges of 1%-7%, the prevalence of bacteremia in this study is lower at 2%. The authors attributed the difference to a possible potential limitation with the other studies, for which culture data was only available for a median 47% of enrollees. Dr. Fritz and her colleagues caution that “because cultures were obtained at the discretion of the treating clinician in a majority of studies, blood cultures were likely obtained more often in those with more severe illness or who had not already received antibiotics.” In this scenario, the likelihood that prevalence of bacteremia was overestimated is noteworthy.

The authors observed that penicillin-susceptible S. pneumonia was the most common cause of bacteremic CAP. They further acknowledged that their study and findings by Neuman et al. in 2017 give credence to the joint 2011 PIDS/IDSA guideline recommending narrow-spectrum aminopenicillins specifically to treat children hospitalized due to suspected bacterial CAP.

Despite its small sample size, the results of this study clearly demonstrate that children with bacteremia because of S. pyogenes or S. aureus experience increased morbidity, compared with children with S. pneumoniae, they said

While this is acknowledged to be one of the largest studies of its kind to date, a key limitation was the small number of observable patients with bacteremia, which prevented the researchers from conducting a more in-depth analysis of risk factors and pathogen-specific differences. That one-fourth of patients received in-patient antibiotics before cultures could be collected also likely led to an underestimation of risk factors and misclassification bias. Lastly, the use of blood culture instead of whole-blood polymerase chain reaction, which is known to be more sensitive, also may have led to underestimation of overall bacteremia prevalence.

“In an era with widespread pneumococcal vaccination and low prevalence of bacteremia in the United States, children admitted with CAP that have pleural effusion or require ICU admission may represent a high-yield population for identifying bacteremia,” noted Dr. Fritz and associates.

Dr. Fritz had no conflicts of interest to report. Some coauthors cited multiple sources of potential conflict of interest related to consulting fees, grant support, and research support from various pharmaceutical companies and agencies. The study was funded by the National Institutes of Health and in part by a grant from the National Institute of Allergy and Infectious Diseases.

SOURCE: Fritz C et al. Pediatrics. 2019;144(1):e20183090.

A study found that only 2% of children hospitalized with community-acquired pneumonia (CAP) actually had any causative pathogen in their blood culture results, despite national guidelines that recommend blood cultures for all children hospitalized with moderate to severe CAP.

CDC/Dr. Mike Miller

The guidelines are the 2011 guidelines for managing CAP published by the Pediatric Infectious Diseases Society (PIDS) and the Infectious Diseases Society of America (IDSA) (Clin Infect Dis. 2011 Oct;53[7]:617-30).

Cristin O. Fritz, MD, of the Children’s Hospital of Colorado, Aurora, and associates conducted a data analysis of the EPIC (Etiology of Pneumonia in the Community) study to estimate prevalence, risk factors, and clinical outcomes in children hospitalized with bacteremic CAP and to evaluate the relationship between positive blood culture results, empirical antibiotics, and changes in antibiotic treatment regimens.

Data were collected at two Tennessee hospitals and one Utah hospital during Jan. 1, 2010–June 30, 2012. Of the 2,358 children with CAP enrolled in the study, 2,143 (91%) with blood cultures were included in Dr. Fritz’s analysis. Of the 53 patients presenting with positive blood culture results, 46 (2%; 95% confidence interval: 1.6%-2.9%) were identified as having bacteremia. Half of all cases observed were caused by Streptococcus pneumoniae, with Staphylococcus aureus and Streptococcus pyogenes noted less frequently, according to the study published in Pediatrics.

A previous meta-analysis of smaller studies also found that children with CAP rarely had positive blood culture results, a pooled prevalence of 5% (Pediatr Infect Dis J. 2013;32[7]:736-40). Although it is believed that positive blood culture results are key to narrowing the choice of antibiotic and predicting treatment outcomes, the literature – to date – reveals a paucity of data supporting this assumption.

Overall, children in the study presenting with bacteremia experienced more severe clinical outcomes, including longer length of stay, greater likelihood of ICU admission, and invasive mechanical ventilation and/or shock. The authors also observed that bacteremia was less likely to be detected in children given antibiotics after admission but before cultures were obtained (0.8% vs 3%; P = .021). Pleural effusion detected with chest radiograph also consistently indicated bacteremic pneumonia, an observation made within this and other similar studies.

Also of note in detection is the biomarker procalcitonin, which is typically present with bacterial disease. Dr. Fritz and colleagues stressed that because the procalcitonin rate was higher in patients presenting with bacteremia, “this information could influence decisions around culturing if results are rapidly available.” Risk-stratification tools also might serve a valuable purpose in ferreting out those patients presenting with moderate to severe pneumonia most at increased risk for bacterial CAP.

Compared with other studies reporting prevalence ranges of 1%-7%, the prevalence of bacteremia in this study is lower at 2%. The authors attributed the difference to a possible potential limitation with the other studies, for which culture data was only available for a median 47% of enrollees. Dr. Fritz and her colleagues caution that “because cultures were obtained at the discretion of the treating clinician in a majority of studies, blood cultures were likely obtained more often in those with more severe illness or who had not already received antibiotics.” In this scenario, the likelihood that prevalence of bacteremia was overestimated is noteworthy.

The authors observed that penicillin-susceptible S. pneumonia was the most common cause of bacteremic CAP. They further acknowledged that their study and findings by Neuman et al. in 2017 give credence to the joint 2011 PIDS/IDSA guideline recommending narrow-spectrum aminopenicillins specifically to treat children hospitalized due to suspected bacterial CAP.

Despite its small sample size, the results of this study clearly demonstrate that children with bacteremia because of S. pyogenes or S. aureus experience increased morbidity, compared with children with S. pneumoniae, they said

While this is acknowledged to be one of the largest studies of its kind to date, a key limitation was the small number of observable patients with bacteremia, which prevented the researchers from conducting a more in-depth analysis of risk factors and pathogen-specific differences. That one-fourth of patients received in-patient antibiotics before cultures could be collected also likely led to an underestimation of risk factors and misclassification bias. Lastly, the use of blood culture instead of whole-blood polymerase chain reaction, which is known to be more sensitive, also may have led to underestimation of overall bacteremia prevalence.

“In an era with widespread pneumococcal vaccination and low prevalence of bacteremia in the United States, children admitted with CAP that have pleural effusion or require ICU admission may represent a high-yield population for identifying bacteremia,” noted Dr. Fritz and associates.

Dr. Fritz had no conflicts of interest to report. Some coauthors cited multiple sources of potential conflict of interest related to consulting fees, grant support, and research support from various pharmaceutical companies and agencies. The study was funded by the National Institutes of Health and in part by a grant from the National Institute of Allergy and Infectious Diseases.

SOURCE: Fritz C et al. Pediatrics. 2019;144(1):e20183090.

A study found that only 2% of children hospitalized with community-acquired pneumonia (CAP) actually had any causative pathogen in their blood culture results, despite national guidelines that recommend blood cultures for all children hospitalized with moderate to severe CAP.

CDC/Dr. Mike Miller

The guidelines are the 2011 guidelines for managing CAP published by the Pediatric Infectious Diseases Society (PIDS) and the Infectious Diseases Society of America (IDSA) (Clin Infect Dis. 2011 Oct;53[7]:617-30).

Cristin O. Fritz, MD, of the Children’s Hospital of Colorado, Aurora, and associates conducted a data analysis of the EPIC (Etiology of Pneumonia in the Community) study to estimate prevalence, risk factors, and clinical outcomes in children hospitalized with bacteremic CAP and to evaluate the relationship between positive blood culture results, empirical antibiotics, and changes in antibiotic treatment regimens.

Data were collected at two Tennessee hospitals and one Utah hospital during Jan. 1, 2010–June 30, 2012. Of the 2,358 children with CAP enrolled in the study, 2,143 (91%) with blood cultures were included in Dr. Fritz’s analysis. Of the 53 patients presenting with positive blood culture results, 46 (2%; 95% confidence interval: 1.6%-2.9%) were identified as having bacteremia. Half of all cases observed were caused by Streptococcus pneumoniae, with Staphylococcus aureus and Streptococcus pyogenes noted less frequently, according to the study published in Pediatrics.

A previous meta-analysis of smaller studies also found that children with CAP rarely had positive blood culture results, a pooled prevalence of 5% (Pediatr Infect Dis J. 2013;32[7]:736-40). Although it is believed that positive blood culture results are key to narrowing the choice of antibiotic and predicting treatment outcomes, the literature – to date – reveals a paucity of data supporting this assumption.

Overall, children in the study presenting with bacteremia experienced more severe clinical outcomes, including longer length of stay, greater likelihood of ICU admission, and invasive mechanical ventilation and/or shock. The authors also observed that bacteremia was less likely to be detected in children given antibiotics after admission but before cultures were obtained (0.8% vs 3%; P = .021). Pleural effusion detected with chest radiograph also consistently indicated bacteremic pneumonia, an observation made within this and other similar studies.

Also of note in detection is the biomarker procalcitonin, which is typically present with bacterial disease. Dr. Fritz and colleagues stressed that because the procalcitonin rate was higher in patients presenting with bacteremia, “this information could influence decisions around culturing if results are rapidly available.” Risk-stratification tools also might serve a valuable purpose in ferreting out those patients presenting with moderate to severe pneumonia most at increased risk for bacterial CAP.

Compared with other studies reporting prevalence ranges of 1%-7%, the prevalence of bacteremia in this study is lower at 2%. The authors attributed the difference to a possible potential limitation with the other studies, for which culture data was only available for a median 47% of enrollees. Dr. Fritz and her colleagues caution that “because cultures were obtained at the discretion of the treating clinician in a majority of studies, blood cultures were likely obtained more often in those with more severe illness or who had not already received antibiotics.” In this scenario, the likelihood that prevalence of bacteremia was overestimated is noteworthy.

The authors observed that penicillin-susceptible S. pneumonia was the most common cause of bacteremic CAP. They further acknowledged that their study and findings by Neuman et al. in 2017 give credence to the joint 2011 PIDS/IDSA guideline recommending narrow-spectrum aminopenicillins specifically to treat children hospitalized due to suspected bacterial CAP.

Despite its small sample size, the results of this study clearly demonstrate that children with bacteremia because of S. pyogenes or S. aureus experience increased morbidity, compared with children with S. pneumoniae, they said

While this is acknowledged to be one of the largest studies of its kind to date, a key limitation was the small number of observable patients with bacteremia, which prevented the researchers from conducting a more in-depth analysis of risk factors and pathogen-specific differences. That one-fourth of patients received in-patient antibiotics before cultures could be collected also likely led to an underestimation of risk factors and misclassification bias. Lastly, the use of blood culture instead of whole-blood polymerase chain reaction, which is known to be more sensitive, also may have led to underestimation of overall bacteremia prevalence.

“In an era with widespread pneumococcal vaccination and low prevalence of bacteremia in the United States, children admitted with CAP that have pleural effusion or require ICU admission may represent a high-yield population for identifying bacteremia,” noted Dr. Fritz and associates.

Dr. Fritz had no conflicts of interest to report. Some coauthors cited multiple sources of potential conflict of interest related to consulting fees, grant support, and research support from various pharmaceutical companies and agencies. The study was funded by the National Institutes of Health and in part by a grant from the National Institute of Allergy and Infectious Diseases.

SOURCE: Fritz C et al. Pediatrics. 2019;144(1):e20183090.