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By the numbers: Asthma-COPD overlap deaths
Death rates for combined asthma and chronic obstructive pulmonary disease declined during 1999-2016, but the risk remains higher among women, compared with men, and in certain occupations, according to a recent report from the Centers for Disease Control and Prevention.
There is also an association between mortality and nonworking status among adults aged 25-64 years, which “suggests that asthma-COPD overlap might be associated with substantial morbidity,” Katelynn E. Dodd, MPH, and associates at the CDC’s National Institute for Occupational Safety and Health said in the Morbidity and Mortality Weekly Report. “These patients have been reported to have worse health outcomes than do those with asthma or COPD alone.”
For females with asthma-COPD overlap, the age-adjusted death rate among adults aged 25 years and older dropped from 7.71 per million in 1999 to 4.01 in 2016, with corresponding rates of 6.70 and 3.01 per million for males, they reported.
In 1999-2016, a total of 18,766 U.S. decedents aged ≥25 years had both asthma and COPD assigned as the underlying or contributing cause of death (12,028 women and 6,738 men), for an overall death rate of 5.03 per million persons (women, 5.59; men, 4.30), data from the National Vital Statistics System show.
Additional analysis, based on the calculation of proportionate mortality ratios (PMRs), also showed that mortality varied by occupational status and age for both males and females, the investigators said, noting that workplace exposures, such as dusts and secondhand smoke, are known to cause both asthma and COPD.
The PMR represents the observed number of deaths from asthma-COPD overlap in a specified industry or occupation, divided by the expected number of deaths, so a value over 1.0 indicates that there were more deaths associated with the condition than expected, Ms. Dodd and her associates explained.
Among female decedents, the occupation with the highest PMR that was statistically significant was bartending at 3.28. For men, the highest significant PMR, 5.64, occurred in logging workers. Those rates, however, only applied to one of the two age groups: 25-64 years in women and ≥65 in men, based on data from the National Occupational Mortality Surveillance, which included information from 26 states for the years 1999, 2003, 2004, and 2007-2014.
Occupationally speaking, the one area of common ground between males and females was lack of occupation. PMRs for those aged 25-64 years “were significantly elevated among men (1.98) and women (1.79) who were unemployed, never worked, or were disabled workers,” they said. PMRs were elevated for nonworking older males and females but were not significant.
The elevated PMRs suggest “that asthma-COPD overlap might be associated with substantial morbidity resulting in loss of employment [because] retired and unemployed persons might have left the workforce because of severe asthma or COPD,” the investigators wrote.
SOURCE: Dodd KE et al. MMWR. 2020 Jun 5. 69(22):670-9.
Death rates for combined asthma and chronic obstructive pulmonary disease declined during 1999-2016, but the risk remains higher among women, compared with men, and in certain occupations, according to a recent report from the Centers for Disease Control and Prevention.
There is also an association between mortality and nonworking status among adults aged 25-64 years, which “suggests that asthma-COPD overlap might be associated with substantial morbidity,” Katelynn E. Dodd, MPH, and associates at the CDC’s National Institute for Occupational Safety and Health said in the Morbidity and Mortality Weekly Report. “These patients have been reported to have worse health outcomes than do those with asthma or COPD alone.”
For females with asthma-COPD overlap, the age-adjusted death rate among adults aged 25 years and older dropped from 7.71 per million in 1999 to 4.01 in 2016, with corresponding rates of 6.70 and 3.01 per million for males, they reported.
In 1999-2016, a total of 18,766 U.S. decedents aged ≥25 years had both asthma and COPD assigned as the underlying or contributing cause of death (12,028 women and 6,738 men), for an overall death rate of 5.03 per million persons (women, 5.59; men, 4.30), data from the National Vital Statistics System show.
Additional analysis, based on the calculation of proportionate mortality ratios (PMRs), also showed that mortality varied by occupational status and age for both males and females, the investigators said, noting that workplace exposures, such as dusts and secondhand smoke, are known to cause both asthma and COPD.
The PMR represents the observed number of deaths from asthma-COPD overlap in a specified industry or occupation, divided by the expected number of deaths, so a value over 1.0 indicates that there were more deaths associated with the condition than expected, Ms. Dodd and her associates explained.
Among female decedents, the occupation with the highest PMR that was statistically significant was bartending at 3.28. For men, the highest significant PMR, 5.64, occurred in logging workers. Those rates, however, only applied to one of the two age groups: 25-64 years in women and ≥65 in men, based on data from the National Occupational Mortality Surveillance, which included information from 26 states for the years 1999, 2003, 2004, and 2007-2014.
Occupationally speaking, the one area of common ground between males and females was lack of occupation. PMRs for those aged 25-64 years “were significantly elevated among men (1.98) and women (1.79) who were unemployed, never worked, or were disabled workers,” they said. PMRs were elevated for nonworking older males and females but were not significant.
The elevated PMRs suggest “that asthma-COPD overlap might be associated with substantial morbidity resulting in loss of employment [because] retired and unemployed persons might have left the workforce because of severe asthma or COPD,” the investigators wrote.
SOURCE: Dodd KE et al. MMWR. 2020 Jun 5. 69(22):670-9.
Death rates for combined asthma and chronic obstructive pulmonary disease declined during 1999-2016, but the risk remains higher among women, compared with men, and in certain occupations, according to a recent report from the Centers for Disease Control and Prevention.
There is also an association between mortality and nonworking status among adults aged 25-64 years, which “suggests that asthma-COPD overlap might be associated with substantial morbidity,” Katelynn E. Dodd, MPH, and associates at the CDC’s National Institute for Occupational Safety and Health said in the Morbidity and Mortality Weekly Report. “These patients have been reported to have worse health outcomes than do those with asthma or COPD alone.”
For females with asthma-COPD overlap, the age-adjusted death rate among adults aged 25 years and older dropped from 7.71 per million in 1999 to 4.01 in 2016, with corresponding rates of 6.70 and 3.01 per million for males, they reported.
In 1999-2016, a total of 18,766 U.S. decedents aged ≥25 years had both asthma and COPD assigned as the underlying or contributing cause of death (12,028 women and 6,738 men), for an overall death rate of 5.03 per million persons (women, 5.59; men, 4.30), data from the National Vital Statistics System show.
Additional analysis, based on the calculation of proportionate mortality ratios (PMRs), also showed that mortality varied by occupational status and age for both males and females, the investigators said, noting that workplace exposures, such as dusts and secondhand smoke, are known to cause both asthma and COPD.
The PMR represents the observed number of deaths from asthma-COPD overlap in a specified industry or occupation, divided by the expected number of deaths, so a value over 1.0 indicates that there were more deaths associated with the condition than expected, Ms. Dodd and her associates explained.
Among female decedents, the occupation with the highest PMR that was statistically significant was bartending at 3.28. For men, the highest significant PMR, 5.64, occurred in logging workers. Those rates, however, only applied to one of the two age groups: 25-64 years in women and ≥65 in men, based on data from the National Occupational Mortality Surveillance, which included information from 26 states for the years 1999, 2003, 2004, and 2007-2014.
Occupationally speaking, the one area of common ground between males and females was lack of occupation. PMRs for those aged 25-64 years “were significantly elevated among men (1.98) and women (1.79) who were unemployed, never worked, or were disabled workers,” they said. PMRs were elevated for nonworking older males and females but were not significant.
The elevated PMRs suggest “that asthma-COPD overlap might be associated with substantial morbidity resulting in loss of employment [because] retired and unemployed persons might have left the workforce because of severe asthma or COPD,” the investigators wrote.
SOURCE: Dodd KE et al. MMWR. 2020 Jun 5. 69(22):670-9.
FROM MMWR
FDA approves new antibiotic for HABP/VABP treatment
in people aged 18 years and older.
Approval for Recarbrio was based on results of a randomized, controlled clinical trial of 535 hospitalized adults with hospital-acquired and ventilator-associated bacterial pneumonia who received either Recarbrio or piperacillin-tazobactam. After 28 days, 16% of patients who received Recarbrio and 21% of patients who received piperacillin-tazobactam had died.
The most common adverse events associated with Recarbrio are increased alanine aminotransferase/ aspartate aminotransferase, anemia, diarrhea, hypokalemia, and hyponatremia. Recarbrio was previously approved by the FDA to treat patients with complicated urinary tract infections and complicated intra-abdominal infections who have limited or no alternative treatment options, according to an FDA press release.
“As a public health agency, the FDA addresses the threat of antimicrobial-resistant infections by facilitating the development of safe and effective new treatments. These efforts provide more options to fight serious bacterial infections and get new, safe and effective therapies to patients as soon as possible,” said Sumathi Nambiar, MD, MPH, director of the division of anti-infectives within the office of infectious disease at the Center for Drug Evaluation and Research.
in people aged 18 years and older.
Approval for Recarbrio was based on results of a randomized, controlled clinical trial of 535 hospitalized adults with hospital-acquired and ventilator-associated bacterial pneumonia who received either Recarbrio or piperacillin-tazobactam. After 28 days, 16% of patients who received Recarbrio and 21% of patients who received piperacillin-tazobactam had died.
The most common adverse events associated with Recarbrio are increased alanine aminotransferase/ aspartate aminotransferase, anemia, diarrhea, hypokalemia, and hyponatremia. Recarbrio was previously approved by the FDA to treat patients with complicated urinary tract infections and complicated intra-abdominal infections who have limited or no alternative treatment options, according to an FDA press release.
“As a public health agency, the FDA addresses the threat of antimicrobial-resistant infections by facilitating the development of safe and effective new treatments. These efforts provide more options to fight serious bacterial infections and get new, safe and effective therapies to patients as soon as possible,” said Sumathi Nambiar, MD, MPH, director of the division of anti-infectives within the office of infectious disease at the Center for Drug Evaluation and Research.
in people aged 18 years and older.
Approval for Recarbrio was based on results of a randomized, controlled clinical trial of 535 hospitalized adults with hospital-acquired and ventilator-associated bacterial pneumonia who received either Recarbrio or piperacillin-tazobactam. After 28 days, 16% of patients who received Recarbrio and 21% of patients who received piperacillin-tazobactam had died.
The most common adverse events associated with Recarbrio are increased alanine aminotransferase/ aspartate aminotransferase, anemia, diarrhea, hypokalemia, and hyponatremia. Recarbrio was previously approved by the FDA to treat patients with complicated urinary tract infections and complicated intra-abdominal infections who have limited or no alternative treatment options, according to an FDA press release.
“As a public health agency, the FDA addresses the threat of antimicrobial-resistant infections by facilitating the development of safe and effective new treatments. These efforts provide more options to fight serious bacterial infections and get new, safe and effective therapies to patients as soon as possible,” said Sumathi Nambiar, MD, MPH, director of the division of anti-infectives within the office of infectious disease at the Center for Drug Evaluation and Research.
Americans avoided emergency departments early in the pandemic
compared with the corresponding period in 2019, according to a report from the Centers for Disease Control and Prevention.
“The striking decline in ED visits nationwide … suggests that the pandemic has altered the use of the ED by the public,” Kathleen P. Hartnett, PhD, and associates at the CDC said June 3 in the Mortality and Morbidity Weekly Report.
The weekly mean was just over 1.2 million ED visits for the 4 weeks from March 29 to April 25, 2020, compared with the nearly 2.2 million visits per week recorded from March 31 to April 27, 2019 – a drop of 42%, based on an analysis of data from the National Syndromic Surveillance Program.
Despite that drop, ED visits for infectious disease–related reasons, taken as a proportion of all 1.2 ED visits during the early pandemic period, were 3.8 times higher than the comparison period in 2019, the investigators reported.
ED visits also were higher in 2020 for specified and unspecified lower respiratory disease not including influenza, pneumonia, asthma, or bronchitis (prevalence ratio of 1.99, compared with 2019), cardiac arrest and ventricular fibrillation (PR, 1.98), and pneumonia not caused by tuberculosis (PR, 1.91), Dr. Hartnett and associates said.
Prevalence ratios for the early pandemic period were down for most other conditions, with some of the largest decreases seen for influenza (PR, 0.16), otitis media (PR, 0.35), and neoplasm-related encounters (PR, 0.40), they said.
Visits have increased each week since reaching their lowest point during April 12-18, but the number for the most recent full week, May 24-30, which was not included in the analysis, was still 26% lower than the corresponding week in 2019, the CDC team pointed out.
“Some persons could be delaying care for conditions that might result in additional mortality if left untreated,” the investigators noted, and those “who use the ED as a safety net because they lack access to primary care and telemedicine might be disproportionately affected if they avoid seeking care because of concerns about the infection risk in the ED.”
SOURCE: Hartnett KP et al. MMWR. 2020 Jun 3. 69:1-6.
compared with the corresponding period in 2019, according to a report from the Centers for Disease Control and Prevention.
“The striking decline in ED visits nationwide … suggests that the pandemic has altered the use of the ED by the public,” Kathleen P. Hartnett, PhD, and associates at the CDC said June 3 in the Mortality and Morbidity Weekly Report.
The weekly mean was just over 1.2 million ED visits for the 4 weeks from March 29 to April 25, 2020, compared with the nearly 2.2 million visits per week recorded from March 31 to April 27, 2019 – a drop of 42%, based on an analysis of data from the National Syndromic Surveillance Program.
Despite that drop, ED visits for infectious disease–related reasons, taken as a proportion of all 1.2 ED visits during the early pandemic period, were 3.8 times higher than the comparison period in 2019, the investigators reported.
ED visits also were higher in 2020 for specified and unspecified lower respiratory disease not including influenza, pneumonia, asthma, or bronchitis (prevalence ratio of 1.99, compared with 2019), cardiac arrest and ventricular fibrillation (PR, 1.98), and pneumonia not caused by tuberculosis (PR, 1.91), Dr. Hartnett and associates said.
Prevalence ratios for the early pandemic period were down for most other conditions, with some of the largest decreases seen for influenza (PR, 0.16), otitis media (PR, 0.35), and neoplasm-related encounters (PR, 0.40), they said.
Visits have increased each week since reaching their lowest point during April 12-18, but the number for the most recent full week, May 24-30, which was not included in the analysis, was still 26% lower than the corresponding week in 2019, the CDC team pointed out.
“Some persons could be delaying care for conditions that might result in additional mortality if left untreated,” the investigators noted, and those “who use the ED as a safety net because they lack access to primary care and telemedicine might be disproportionately affected if they avoid seeking care because of concerns about the infection risk in the ED.”
SOURCE: Hartnett KP et al. MMWR. 2020 Jun 3. 69:1-6.
compared with the corresponding period in 2019, according to a report from the Centers for Disease Control and Prevention.
“The striking decline in ED visits nationwide … suggests that the pandemic has altered the use of the ED by the public,” Kathleen P. Hartnett, PhD, and associates at the CDC said June 3 in the Mortality and Morbidity Weekly Report.
The weekly mean was just over 1.2 million ED visits for the 4 weeks from March 29 to April 25, 2020, compared with the nearly 2.2 million visits per week recorded from March 31 to April 27, 2019 – a drop of 42%, based on an analysis of data from the National Syndromic Surveillance Program.
Despite that drop, ED visits for infectious disease–related reasons, taken as a proportion of all 1.2 ED visits during the early pandemic period, were 3.8 times higher than the comparison period in 2019, the investigators reported.
ED visits also were higher in 2020 for specified and unspecified lower respiratory disease not including influenza, pneumonia, asthma, or bronchitis (prevalence ratio of 1.99, compared with 2019), cardiac arrest and ventricular fibrillation (PR, 1.98), and pneumonia not caused by tuberculosis (PR, 1.91), Dr. Hartnett and associates said.
Prevalence ratios for the early pandemic period were down for most other conditions, with some of the largest decreases seen for influenza (PR, 0.16), otitis media (PR, 0.35), and neoplasm-related encounters (PR, 0.40), they said.
Visits have increased each week since reaching their lowest point during April 12-18, but the number for the most recent full week, May 24-30, which was not included in the analysis, was still 26% lower than the corresponding week in 2019, the CDC team pointed out.
“Some persons could be delaying care for conditions that might result in additional mortality if left untreated,” the investigators noted, and those “who use the ED as a safety net because they lack access to primary care and telemedicine might be disproportionately affected if they avoid seeking care because of concerns about the infection risk in the ED.”
SOURCE: Hartnett KP et al. MMWR. 2020 Jun 3. 69:1-6.
FROM MMWR
FDA approves ramucirumab-erlotinib combo for metastatic NSCLC
The approval was supported by results from the phase 3 RELAY trial (Lancet Oncol. 2019 Dec;20[12]:1655-69). The trial enrolled 449 patients with previously untreated, EGFR-mutated, metastatic NSCLC.
Patients received either ramucirumab at 10 mg/kg or placebo every 2 weeks as an intravenous infusion in combination with erlotinib at 150 mg orally once daily. Patients continued treatment until they progressed or developed unacceptable toxicity. The median progression-free survival was 19.4 months in the ramucirumab-erlotinib arm, compared with 12.4 months in the placebo-erlotinib arm (hazard ratio, 0.59; 95% confidence interval, 0.46-0.76; P < .0001). The overall response rate was 76% in the ramucirumab arm and 75% in the placebo arm. The median duration of response was 18.0 months and 11.1 months, respectively. Overall survival data were not mature at the final analysis.
Adverse events that were more common in the ramucirumab arm were infections, hypertension, stomatitis, proteinuria, alopecia, epistaxis, and peripheral edema. Full prescribing information is available on the FDA website.
The approval was supported by results from the phase 3 RELAY trial (Lancet Oncol. 2019 Dec;20[12]:1655-69). The trial enrolled 449 patients with previously untreated, EGFR-mutated, metastatic NSCLC.
Patients received either ramucirumab at 10 mg/kg or placebo every 2 weeks as an intravenous infusion in combination with erlotinib at 150 mg orally once daily. Patients continued treatment until they progressed or developed unacceptable toxicity. The median progression-free survival was 19.4 months in the ramucirumab-erlotinib arm, compared with 12.4 months in the placebo-erlotinib arm (hazard ratio, 0.59; 95% confidence interval, 0.46-0.76; P < .0001). The overall response rate was 76% in the ramucirumab arm and 75% in the placebo arm. The median duration of response was 18.0 months and 11.1 months, respectively. Overall survival data were not mature at the final analysis.
Adverse events that were more common in the ramucirumab arm were infections, hypertension, stomatitis, proteinuria, alopecia, epistaxis, and peripheral edema. Full prescribing information is available on the FDA website.
The approval was supported by results from the phase 3 RELAY trial (Lancet Oncol. 2019 Dec;20[12]:1655-69). The trial enrolled 449 patients with previously untreated, EGFR-mutated, metastatic NSCLC.
Patients received either ramucirumab at 10 mg/kg or placebo every 2 weeks as an intravenous infusion in combination with erlotinib at 150 mg orally once daily. Patients continued treatment until they progressed or developed unacceptable toxicity. The median progression-free survival was 19.4 months in the ramucirumab-erlotinib arm, compared with 12.4 months in the placebo-erlotinib arm (hazard ratio, 0.59; 95% confidence interval, 0.46-0.76; P < .0001). The overall response rate was 76% in the ramucirumab arm and 75% in the placebo arm. The median duration of response was 18.0 months and 11.1 months, respectively. Overall survival data were not mature at the final analysis.
Adverse events that were more common in the ramucirumab arm were infections, hypertension, stomatitis, proteinuria, alopecia, epistaxis, and peripheral edema. Full prescribing information is available on the FDA website.
FDA approves mAb combo for hepatocellular carcinoma
The approval was supported by results from the IMbrave150 trial (N Engl J Med. 2020;382:1894-1905). This phase 3 trial enrolled 501 patients with hepatocellular carcinoma who were randomized to receive either sorafenib or atezolizumab plus bevacizumab.
The median overall survival was not reached in patients who received atezolizumab plus bevacizumab, but it was 13.2 months in patients who received sorafenib (hazard ratio, 0.58; 95% confidence interval, 0.42-0.79; P = .0006). The median progression-free survival was 6.8 months in patients who received atezolizumab plus bevacizumab and 4.3 months for those who received sorafenib.
The most common adverse events seen in the atezolizumab-bevacizumab arm were hypertension, fatigue, and proteinuria.
The recommended atezolizumab dose is 1,200 mg, followed by 15 mg/kg bevacizumab on the same day every 3 weeks.
The FDA collaborated with regulatory agencies from Canada, Australia, and Singapore on the review of the atezolizumab application, as part of Project Orbis. The FDA approved the application ahead of schedule. It is still under review for the other agencies.
The approval was supported by results from the IMbrave150 trial (N Engl J Med. 2020;382:1894-1905). This phase 3 trial enrolled 501 patients with hepatocellular carcinoma who were randomized to receive either sorafenib or atezolizumab plus bevacizumab.
The median overall survival was not reached in patients who received atezolizumab plus bevacizumab, but it was 13.2 months in patients who received sorafenib (hazard ratio, 0.58; 95% confidence interval, 0.42-0.79; P = .0006). The median progression-free survival was 6.8 months in patients who received atezolizumab plus bevacizumab and 4.3 months for those who received sorafenib.
The most common adverse events seen in the atezolizumab-bevacizumab arm were hypertension, fatigue, and proteinuria.
The recommended atezolizumab dose is 1,200 mg, followed by 15 mg/kg bevacizumab on the same day every 3 weeks.
The FDA collaborated with regulatory agencies from Canada, Australia, and Singapore on the review of the atezolizumab application, as part of Project Orbis. The FDA approved the application ahead of schedule. It is still under review for the other agencies.
The approval was supported by results from the IMbrave150 trial (N Engl J Med. 2020;382:1894-1905). This phase 3 trial enrolled 501 patients with hepatocellular carcinoma who were randomized to receive either sorafenib or atezolizumab plus bevacizumab.
The median overall survival was not reached in patients who received atezolizumab plus bevacizumab, but it was 13.2 months in patients who received sorafenib (hazard ratio, 0.58; 95% confidence interval, 0.42-0.79; P = .0006). The median progression-free survival was 6.8 months in patients who received atezolizumab plus bevacizumab and 4.3 months for those who received sorafenib.
The most common adverse events seen in the atezolizumab-bevacizumab arm were hypertension, fatigue, and proteinuria.
The recommended atezolizumab dose is 1,200 mg, followed by 15 mg/kg bevacizumab on the same day every 3 weeks.
The FDA collaborated with regulatory agencies from Canada, Australia, and Singapore on the review of the atezolizumab application, as part of Project Orbis. The FDA approved the application ahead of schedule. It is still under review for the other agencies.
FDA approves ixekizumab for nonradiographic axSpA
The Food and Drug Administration has extended approval of ixekizumab (Taltz) to the treatment of nonradiographic axial spondyloarthritis (nr-axSpA), according to a press release from its manufacturer, Eli Lilly. Specifically, this supplemental biologics license application refers to nr-axSpA with objective signs of inflammation.
The monoclonal interleukin-17A antagonist has three other indications, including ankylosing spondylitis in adults, psoriatic arthritis in adults, and plaque psoriasis in adults and children aged 6 years and older. It is the first IL-17A antagonist to receive FDA approval for nr-axSpA.
Approval for this indication was based on the phase 3, randomized, double-blind COAST-X trial, which put 96 nr-axSpA patients on 80-mg injections of ixekizumab every 4 weeks and 105 on placebo. After 52 weeks, ixekizumab was superior on the trial’s primary endpoint: 30% of patients had achieved a 40% improvement in Assessment of Spondyloarthritis International Society response criteria (ASAS 40), compared with 13% of patients on placebo (P = .0045).
Warnings and precautions for ixekizumab include considering potentially increased risk of infection and inflammatory bowel disease, as well as evaluating patients for tuberculosis before treatment. The most common adverse reactions (≥1%) are injection-site reactions, upper respiratory tract infections, nausea, and tinea infections. The safety profile for ixekizumab among nr-axSpA patients is mostly consistent with that seen among patients receiving it for other indications, according to Lilly. The full prescribing information is available on Lilly’s website.
The Food and Drug Administration has extended approval of ixekizumab (Taltz) to the treatment of nonradiographic axial spondyloarthritis (nr-axSpA), according to a press release from its manufacturer, Eli Lilly. Specifically, this supplemental biologics license application refers to nr-axSpA with objective signs of inflammation.
The monoclonal interleukin-17A antagonist has three other indications, including ankylosing spondylitis in adults, psoriatic arthritis in adults, and plaque psoriasis in adults and children aged 6 years and older. It is the first IL-17A antagonist to receive FDA approval for nr-axSpA.
Approval for this indication was based on the phase 3, randomized, double-blind COAST-X trial, which put 96 nr-axSpA patients on 80-mg injections of ixekizumab every 4 weeks and 105 on placebo. After 52 weeks, ixekizumab was superior on the trial’s primary endpoint: 30% of patients had achieved a 40% improvement in Assessment of Spondyloarthritis International Society response criteria (ASAS 40), compared with 13% of patients on placebo (P = .0045).
Warnings and precautions for ixekizumab include considering potentially increased risk of infection and inflammatory bowel disease, as well as evaluating patients for tuberculosis before treatment. The most common adverse reactions (≥1%) are injection-site reactions, upper respiratory tract infections, nausea, and tinea infections. The safety profile for ixekizumab among nr-axSpA patients is mostly consistent with that seen among patients receiving it for other indications, according to Lilly. The full prescribing information is available on Lilly’s website.
The Food and Drug Administration has extended approval of ixekizumab (Taltz) to the treatment of nonradiographic axial spondyloarthritis (nr-axSpA), according to a press release from its manufacturer, Eli Lilly. Specifically, this supplemental biologics license application refers to nr-axSpA with objective signs of inflammation.
The monoclonal interleukin-17A antagonist has three other indications, including ankylosing spondylitis in adults, psoriatic arthritis in adults, and plaque psoriasis in adults and children aged 6 years and older. It is the first IL-17A antagonist to receive FDA approval for nr-axSpA.
Approval for this indication was based on the phase 3, randomized, double-blind COAST-X trial, which put 96 nr-axSpA patients on 80-mg injections of ixekizumab every 4 weeks and 105 on placebo. After 52 weeks, ixekizumab was superior on the trial’s primary endpoint: 30% of patients had achieved a 40% improvement in Assessment of Spondyloarthritis International Society response criteria (ASAS 40), compared with 13% of patients on placebo (P = .0045).
Warnings and precautions for ixekizumab include considering potentially increased risk of infection and inflammatory bowel disease, as well as evaluating patients for tuberculosis before treatment. The most common adverse reactions (≥1%) are injection-site reactions, upper respiratory tract infections, nausea, and tinea infections. The safety profile for ixekizumab among nr-axSpA patients is mostly consistent with that seen among patients receiving it for other indications, according to Lilly. The full prescribing information is available on Lilly’s website.
Frontline nivo-ipi plus chemo approved for metastatic NSCLC
The Food and Drug Administration has approved the combination of nivolumab (Opdivo), ipilimumab (Yervoy), and two cycles of platinum-doublet chemotherapy as frontline treatment for patients with metastatic or recurrent non–small cell lung cancer (NSCLC) who have no EGFR or ALK genomic tumor aberrations.
The FDA collaborated with the Australian Therapeutic Goods Administration, Health Canada, and Singapore’s Health Sciences Authority on the review that led to this approval, as part of Project Orbis. The FDA approved the application 2 months ahead of schedule.
The combination chemotherapy was investigated in the CHECKMATE-9LA trial (NCT03215706), which enrolled patients with metastatic or recurrent NSCLC.
Patients were randomized to receive nivolumab plus ipilimumab and two cycles of platinum-doublet chemotherapy (n = 361) or platinum-doublet chemotherapy for four cycles (n = 358).
There was a significant overall survival benefit in the nivolumab-ipilimumab arm, compared with the chemotherapy-only arm. The median overall survival was 14.1 months and 10.7 months, respectively (hazard ratio, 0.69; P = .0006).
The median progression-free survival was 6.8 months in the nivolumab-ipilimumab arm and 5 months in the chemotherapy-only arm (HR, 0.70; P = .0001). The overall response rate was 38% and 25%, respectively (P = .0003).
The most common adverse events in the nivolumab-ipilimumab arm, which occurred in at least 20% of patients, were fatigue, musculoskeletal pain, nausea, diarrhea, rash, decreased appetite, constipation, and pruritus.
Serious adverse events occurred in 57% of patients in the nivolumab-ipilimumab arm. Fatal adverse events occurred in seven patients (2%) in that arm. Fatal events were hepatic toxicity, acute renal failure, sepsis, pneumonitis, diarrhea with hypokalemia, and massive hemoptysis in the setting of thrombocytopenia.
For more details, see the full prescribing information for nivolumab or ipilimumab. Nivolumab and ipilimumab are both products of Bristol-Myers Squibb.
The Food and Drug Administration has approved the combination of nivolumab (Opdivo), ipilimumab (Yervoy), and two cycles of platinum-doublet chemotherapy as frontline treatment for patients with metastatic or recurrent non–small cell lung cancer (NSCLC) who have no EGFR or ALK genomic tumor aberrations.
The FDA collaborated with the Australian Therapeutic Goods Administration, Health Canada, and Singapore’s Health Sciences Authority on the review that led to this approval, as part of Project Orbis. The FDA approved the application 2 months ahead of schedule.
The combination chemotherapy was investigated in the CHECKMATE-9LA trial (NCT03215706), which enrolled patients with metastatic or recurrent NSCLC.
Patients were randomized to receive nivolumab plus ipilimumab and two cycles of platinum-doublet chemotherapy (n = 361) or platinum-doublet chemotherapy for four cycles (n = 358).
There was a significant overall survival benefit in the nivolumab-ipilimumab arm, compared with the chemotherapy-only arm. The median overall survival was 14.1 months and 10.7 months, respectively (hazard ratio, 0.69; P = .0006).
The median progression-free survival was 6.8 months in the nivolumab-ipilimumab arm and 5 months in the chemotherapy-only arm (HR, 0.70; P = .0001). The overall response rate was 38% and 25%, respectively (P = .0003).
The most common adverse events in the nivolumab-ipilimumab arm, which occurred in at least 20% of patients, were fatigue, musculoskeletal pain, nausea, diarrhea, rash, decreased appetite, constipation, and pruritus.
Serious adverse events occurred in 57% of patients in the nivolumab-ipilimumab arm. Fatal adverse events occurred in seven patients (2%) in that arm. Fatal events were hepatic toxicity, acute renal failure, sepsis, pneumonitis, diarrhea with hypokalemia, and massive hemoptysis in the setting of thrombocytopenia.
For more details, see the full prescribing information for nivolumab or ipilimumab. Nivolumab and ipilimumab are both products of Bristol-Myers Squibb.
The Food and Drug Administration has approved the combination of nivolumab (Opdivo), ipilimumab (Yervoy), and two cycles of platinum-doublet chemotherapy as frontline treatment for patients with metastatic or recurrent non–small cell lung cancer (NSCLC) who have no EGFR or ALK genomic tumor aberrations.
The FDA collaborated with the Australian Therapeutic Goods Administration, Health Canada, and Singapore’s Health Sciences Authority on the review that led to this approval, as part of Project Orbis. The FDA approved the application 2 months ahead of schedule.
The combination chemotherapy was investigated in the CHECKMATE-9LA trial (NCT03215706), which enrolled patients with metastatic or recurrent NSCLC.
Patients were randomized to receive nivolumab plus ipilimumab and two cycles of platinum-doublet chemotherapy (n = 361) or platinum-doublet chemotherapy for four cycles (n = 358).
There was a significant overall survival benefit in the nivolumab-ipilimumab arm, compared with the chemotherapy-only arm. The median overall survival was 14.1 months and 10.7 months, respectively (hazard ratio, 0.69; P = .0006).
The median progression-free survival was 6.8 months in the nivolumab-ipilimumab arm and 5 months in the chemotherapy-only arm (HR, 0.70; P = .0001). The overall response rate was 38% and 25%, respectively (P = .0003).
The most common adverse events in the nivolumab-ipilimumab arm, which occurred in at least 20% of patients, were fatigue, musculoskeletal pain, nausea, diarrhea, rash, decreased appetite, constipation, and pruritus.
Serious adverse events occurred in 57% of patients in the nivolumab-ipilimumab arm. Fatal adverse events occurred in seven patients (2%) in that arm. Fatal events were hepatic toxicity, acute renal failure, sepsis, pneumonitis, diarrhea with hypokalemia, and massive hemoptysis in the setting of thrombocytopenia.
For more details, see the full prescribing information for nivolumab or ipilimumab. Nivolumab and ipilimumab are both products of Bristol-Myers Squibb.
FDA approves brigatinib and companion diagnostic for NSCLC
The Food and Drug Administration has approved brigatinib (Alunbrig) to treat adults with ALK-positive metastatic non–small cell lung cancer (NSCLC) as detected by an FDA-approved test.
The FDA also approved the Vysis ALK Break Apart FISH Probe Kit as a companion diagnostic for brigatinib.
Brigatinib and the companion diagnostic were both evaluated in the ALTA 1L trial (NCT02737501). The trial enrolled adults with advanced ALK-positive NSCLC who had not previously received an ALK-targeted therapy. Patients had to have an ALK rearrangement based on a local standard of care test.
Clinical samples from trial participants were retrospectively tested with the Vysis ALK Break Apart FISH Probe Kit. Of the 275 patients enrolled in the trial, 239 were ALK positive according to the test. Results were negative for 20 patients and unavailable for 16 patients.
Patients were randomized to receive brigatinib at 180 mg once daily with a 7-day lead-in at 90 mg once daily (n = 137) or crizotinib at 250 mg twice daily (n = 138).
The estimated median progression-free survival was 24 months in the brigatinib arm and 11 months in the crizotinib arm (hazard ratio, 0.49; P < .0001). The overall response rate was 74% in the brigatinib arm and 62% in the crizotinib arm.
The most common adverse events in the brigatinib arm, occurring in at least 20% of patients, were diarrhea, fatigue, nausea, rash, cough, myalgia, headache, hypertension, vomiting, abdominal pain, pruritus, back pain, and dyspnea.
Serious adverse events occurred in 33% of patients in the brigatinib arm, and fatal adverse events included in 2.9%. The fatal events were pneumonia (1.5%), cerebrovascular accident (0.7%), and multiple organ dysfunction syndrome (0.7%).
For more details on the ALTA 1L trial, see the full prescribing information for brigatinib.
The approval of brigatinib was granted to ARIAD Pharmaceuticals. The approval of the Vysis ALK Break Apart FISH Probe Kit was granted to Abbott Molecular.
The Food and Drug Administration has approved brigatinib (Alunbrig) to treat adults with ALK-positive metastatic non–small cell lung cancer (NSCLC) as detected by an FDA-approved test.
The FDA also approved the Vysis ALK Break Apart FISH Probe Kit as a companion diagnostic for brigatinib.
Brigatinib and the companion diagnostic were both evaluated in the ALTA 1L trial (NCT02737501). The trial enrolled adults with advanced ALK-positive NSCLC who had not previously received an ALK-targeted therapy. Patients had to have an ALK rearrangement based on a local standard of care test.
Clinical samples from trial participants were retrospectively tested with the Vysis ALK Break Apart FISH Probe Kit. Of the 275 patients enrolled in the trial, 239 were ALK positive according to the test. Results were negative for 20 patients and unavailable for 16 patients.
Patients were randomized to receive brigatinib at 180 mg once daily with a 7-day lead-in at 90 mg once daily (n = 137) or crizotinib at 250 mg twice daily (n = 138).
The estimated median progression-free survival was 24 months in the brigatinib arm and 11 months in the crizotinib arm (hazard ratio, 0.49; P < .0001). The overall response rate was 74% in the brigatinib arm and 62% in the crizotinib arm.
The most common adverse events in the brigatinib arm, occurring in at least 20% of patients, were diarrhea, fatigue, nausea, rash, cough, myalgia, headache, hypertension, vomiting, abdominal pain, pruritus, back pain, and dyspnea.
Serious adverse events occurred in 33% of patients in the brigatinib arm, and fatal adverse events included in 2.9%. The fatal events were pneumonia (1.5%), cerebrovascular accident (0.7%), and multiple organ dysfunction syndrome (0.7%).
For more details on the ALTA 1L trial, see the full prescribing information for brigatinib.
The approval of brigatinib was granted to ARIAD Pharmaceuticals. The approval of the Vysis ALK Break Apart FISH Probe Kit was granted to Abbott Molecular.
The Food and Drug Administration has approved brigatinib (Alunbrig) to treat adults with ALK-positive metastatic non–small cell lung cancer (NSCLC) as detected by an FDA-approved test.
The FDA also approved the Vysis ALK Break Apart FISH Probe Kit as a companion diagnostic for brigatinib.
Brigatinib and the companion diagnostic were both evaluated in the ALTA 1L trial (NCT02737501). The trial enrolled adults with advanced ALK-positive NSCLC who had not previously received an ALK-targeted therapy. Patients had to have an ALK rearrangement based on a local standard of care test.
Clinical samples from trial participants were retrospectively tested with the Vysis ALK Break Apart FISH Probe Kit. Of the 275 patients enrolled in the trial, 239 were ALK positive according to the test. Results were negative for 20 patients and unavailable for 16 patients.
Patients were randomized to receive brigatinib at 180 mg once daily with a 7-day lead-in at 90 mg once daily (n = 137) or crizotinib at 250 mg twice daily (n = 138).
The estimated median progression-free survival was 24 months in the brigatinib arm and 11 months in the crizotinib arm (hazard ratio, 0.49; P < .0001). The overall response rate was 74% in the brigatinib arm and 62% in the crizotinib arm.
The most common adverse events in the brigatinib arm, occurring in at least 20% of patients, were diarrhea, fatigue, nausea, rash, cough, myalgia, headache, hypertension, vomiting, abdominal pain, pruritus, back pain, and dyspnea.
Serious adverse events occurred in 33% of patients in the brigatinib arm, and fatal adverse events included in 2.9%. The fatal events were pneumonia (1.5%), cerebrovascular accident (0.7%), and multiple organ dysfunction syndrome (0.7%).
For more details on the ALTA 1L trial, see the full prescribing information for brigatinib.
The approval of brigatinib was granted to ARIAD Pharmaceuticals. The approval of the Vysis ALK Break Apart FISH Probe Kit was granted to Abbott Molecular.
Biologic approved for atopic dermatitis in children
The Food and Drug Administration has approved dupilumab for children aged 6-11 years with moderate to severe atopic dermatitis, the manufacturers announced.
The new indication is for children “whose disease is not adequately controlled with topical prescription therapies or when those therapies are not advisable,” Regeneron and Sanofi said in a press release, which points out that this is the first biologic approved for AD in this age group.
For children aged 6-11, the two available dupilumab (Dupixent) doses in prefilled syringes are given based on weight – 300 mg every 4 weeks for children between 15 to 29 kg and 200 mg every 2 weeks for children 30 to 59 kg – following an initial loading dose.
In phase 3 trials, children with severe AD who received dupilumab and topical corticosteroids improved significantly in overall disease severity, skin clearance, and itch, compared with those getting steroids alone. Eczema Area and Severity Index-75, for example, was reached by 75% of patients on either dupilumab dose, compared with 28% and 26% , respectively, for those receiving steroids alone every 4 and every 2 weeks, the statement said.
Over the 16-week treatment period, overall rates of adverse events were 65% for those getting dupilumab every 4 weeks and 61% for every 2 weeks – compared with steroids alone (72% and 75%, respectively), the statement said.
The fully human monoclonal antibody inhibits signaling of the interleukin-4 and interleukin-13 proteins and is already approved as an add-on maintenance treatment in children aged 12 years and older with moderate to severe asthma (eosinophilic phenotype or oral-corticosteroid dependent) and in adults with inadequately controlled chronic rhinosinusitis with nasal polyposis, according to the prescribing information.
The Food and Drug Administration has approved dupilumab for children aged 6-11 years with moderate to severe atopic dermatitis, the manufacturers announced.
The new indication is for children “whose disease is not adequately controlled with topical prescription therapies or when those therapies are not advisable,” Regeneron and Sanofi said in a press release, which points out that this is the first biologic approved for AD in this age group.
For children aged 6-11, the two available dupilumab (Dupixent) doses in prefilled syringes are given based on weight – 300 mg every 4 weeks for children between 15 to 29 kg and 200 mg every 2 weeks for children 30 to 59 kg – following an initial loading dose.
In phase 3 trials, children with severe AD who received dupilumab and topical corticosteroids improved significantly in overall disease severity, skin clearance, and itch, compared with those getting steroids alone. Eczema Area and Severity Index-75, for example, was reached by 75% of patients on either dupilumab dose, compared with 28% and 26% , respectively, for those receiving steroids alone every 4 and every 2 weeks, the statement said.
Over the 16-week treatment period, overall rates of adverse events were 65% for those getting dupilumab every 4 weeks and 61% for every 2 weeks – compared with steroids alone (72% and 75%, respectively), the statement said.
The fully human monoclonal antibody inhibits signaling of the interleukin-4 and interleukin-13 proteins and is already approved as an add-on maintenance treatment in children aged 12 years and older with moderate to severe asthma (eosinophilic phenotype or oral-corticosteroid dependent) and in adults with inadequately controlled chronic rhinosinusitis with nasal polyposis, according to the prescribing information.
The Food and Drug Administration has approved dupilumab for children aged 6-11 years with moderate to severe atopic dermatitis, the manufacturers announced.
The new indication is for children “whose disease is not adequately controlled with topical prescription therapies or when those therapies are not advisable,” Regeneron and Sanofi said in a press release, which points out that this is the first biologic approved for AD in this age group.
For children aged 6-11, the two available dupilumab (Dupixent) doses in prefilled syringes are given based on weight – 300 mg every 4 weeks for children between 15 to 29 kg and 200 mg every 2 weeks for children 30 to 59 kg – following an initial loading dose.
In phase 3 trials, children with severe AD who received dupilumab and topical corticosteroids improved significantly in overall disease severity, skin clearance, and itch, compared with those getting steroids alone. Eczema Area and Severity Index-75, for example, was reached by 75% of patients on either dupilumab dose, compared with 28% and 26% , respectively, for those receiving steroids alone every 4 and every 2 weeks, the statement said.
Over the 16-week treatment period, overall rates of adverse events were 65% for those getting dupilumab every 4 weeks and 61% for every 2 weeks – compared with steroids alone (72% and 75%, respectively), the statement said.
The fully human monoclonal antibody inhibits signaling of the interleukin-4 and interleukin-13 proteins and is already approved as an add-on maintenance treatment in children aged 12 years and older with moderate to severe asthma (eosinophilic phenotype or oral-corticosteroid dependent) and in adults with inadequately controlled chronic rhinosinusitis with nasal polyposis, according to the prescribing information.
Many clinicians still not asking about postpartum depression
Health care providers fail to ask one in five prenatal patients and one in eight postpartum patients about depression, according to the Centers for Disease Control and Prevention. Although the prevalence of screening has risen in recent years, many women could be suffering in silence.
“[U]ndetected and untreated perinatal depression can have negative health consequences for the mothers and their babies,” said coauthor Jean Y. Ko, PhD, from the division of reproductive health at the National Center for Chronic Disease Prevention and Health Promotion.
Dr. Ko and colleagues reported their findings in an article published in Morbidity and Mortality Weekly Report.
The researchers analyzed self-reported data on postpartum depressive symptoms (PDS) collected in 2018 by the Pregnancy Risk Assessment Monitoring System (PRAMS). Participants were stratified on the basis of location and maternal and infant characteristics, including age, race/ethnicity, and education level. Women who had recently given birth to one or more live infants answered questions about whether they had been screened by health care providers for depression during perinatal visits.
The prevalence of PDS among women from 31 PRAMS sites was 13.2%. States with lower prevalences included Illinois (9.7%), Massachusetts (10.3%), and Wisconsin (10.5%); states with higher prevalences included Mississippi (23.5%), West Virginia (19.4%), and Michigan (16.4%).
Some groups were at higher risk for PDS than others. The prevalence was greater than 20% among women who were aged 19 years or younger, were of American Indian or Alaska Native ethnicity, smoked during the perinatal period, experienced perinatal depression, or whose infant died after birth.
Depressive symptoms were also more common among women who received assistance from the Women, Infants, and Children program; were Medicaid beneficiaries at the time of delivery; smoked cigarettes during the last trimester of pregnancy; breastfed their infants for fewer than 8 weeks; or had experienced intimate partner violence while pregnant or before.
Small rise in screening
Overall, 79.1% of women said a health care provider had inquired about depression during the prenatal period. Prenatal screening for depression was lowest in Puerto Rico (50.7%), Mississippi (69.4%), Utah (69.5%), and Kentucky (69.5%) and was highest in Alaska (90.7%), Minnesota (90.6%), and Maine (90.5%).
Among 22 continuously reporting sites, the prevalence of prenatal depression screening rose significantly from 76.2% in 2016 to 79.3% in 2018 (P < .05) .
“It is unclear what might account for this small increase,” Dr. Ko said. “There may be additional factors, such as women may be becoming more comfortable reporting symptoms of depression. With continued awareness about the need to screen every pregnant and postpartum woman for depression, we can expect things to continue to improve.”
Overall, 90.1% of respondents reported a postpartum visit; of those, 87.4% said a health care provider had asked about depression during that visit.
Screening during the postpartum period was highest in Vermont (96.2%), Minnesota (95.9%), and Maine (95.5%) and was lowest in Puerto Rico (50.7%), New York City (73.1%), and Louisiana (75.0%).
Among the 22 sites that reported continuously, the prevalence of screening for postpartum depression rose significantly from 84.1% to 88.0% (P < .05), “with an average annual percentage point increase of 1.8%,” the authors wrote.
‘Missed opportunities’
“PRAMS responses are reported an average of 4 months postpartum, which suggests persistence of [depressive] symptoms,” the authors wrote.
Dr. Ko said that mental health conditions play a role in approximately 9% of pregnancy-related deaths and that not asking about depression represents “missed opportunities to potentially identify and treat women with depression.” The United States Preventive Services Task Force recommends screening all adults for depression, including women during pregnancy and the postpartum period, she added.
When asked what can be done to improve screening that has not already been tried, Dr. Ko said the CDC is currently evaluating a study called the Program in Support of Moms (PRISM), which “is designed to help obstetrics and gynecology practices address the significant public health issue of depression during and after pregnancy. PRISM aims to close gaps in health care delivery to ensure that women with depression during and after pregnancy receive the best treatment, which can result in improvement in their symptoms.”
Dr. Ko added that the Health Resources and Services Administration has funded seven states to begin “programs to support providers to screen, assess, refer, and treat pregnant and postpartum women for depression and other behavioral health conditions. States can use initiatives like Healthy Start, home visiting, and Title V Maternal and Child Health Services Block Grant programs as levers to improve screening and address maternal depression.
“Screening is just one part of addressing perinatal depression. Health care providers need to refer women to appropriate resources in order to get the proper diagnosis, treatment, and follow-up care for management of depression,” Dr. Ko concluded.
The authors disclosed no relevant financial relationships.
A version of this article originally appeared on Medscape.com.
Health care providers fail to ask one in five prenatal patients and one in eight postpartum patients about depression, according to the Centers for Disease Control and Prevention. Although the prevalence of screening has risen in recent years, many women could be suffering in silence.
“[U]ndetected and untreated perinatal depression can have negative health consequences for the mothers and their babies,” said coauthor Jean Y. Ko, PhD, from the division of reproductive health at the National Center for Chronic Disease Prevention and Health Promotion.
Dr. Ko and colleagues reported their findings in an article published in Morbidity and Mortality Weekly Report.
The researchers analyzed self-reported data on postpartum depressive symptoms (PDS) collected in 2018 by the Pregnancy Risk Assessment Monitoring System (PRAMS). Participants were stratified on the basis of location and maternal and infant characteristics, including age, race/ethnicity, and education level. Women who had recently given birth to one or more live infants answered questions about whether they had been screened by health care providers for depression during perinatal visits.
The prevalence of PDS among women from 31 PRAMS sites was 13.2%. States with lower prevalences included Illinois (9.7%), Massachusetts (10.3%), and Wisconsin (10.5%); states with higher prevalences included Mississippi (23.5%), West Virginia (19.4%), and Michigan (16.4%).
Some groups were at higher risk for PDS than others. The prevalence was greater than 20% among women who were aged 19 years or younger, were of American Indian or Alaska Native ethnicity, smoked during the perinatal period, experienced perinatal depression, or whose infant died after birth.
Depressive symptoms were also more common among women who received assistance from the Women, Infants, and Children program; were Medicaid beneficiaries at the time of delivery; smoked cigarettes during the last trimester of pregnancy; breastfed their infants for fewer than 8 weeks; or had experienced intimate partner violence while pregnant or before.
Small rise in screening
Overall, 79.1% of women said a health care provider had inquired about depression during the prenatal period. Prenatal screening for depression was lowest in Puerto Rico (50.7%), Mississippi (69.4%), Utah (69.5%), and Kentucky (69.5%) and was highest in Alaska (90.7%), Minnesota (90.6%), and Maine (90.5%).
Among 22 continuously reporting sites, the prevalence of prenatal depression screening rose significantly from 76.2% in 2016 to 79.3% in 2018 (P < .05) .
“It is unclear what might account for this small increase,” Dr. Ko said. “There may be additional factors, such as women may be becoming more comfortable reporting symptoms of depression. With continued awareness about the need to screen every pregnant and postpartum woman for depression, we can expect things to continue to improve.”
Overall, 90.1% of respondents reported a postpartum visit; of those, 87.4% said a health care provider had asked about depression during that visit.
Screening during the postpartum period was highest in Vermont (96.2%), Minnesota (95.9%), and Maine (95.5%) and was lowest in Puerto Rico (50.7%), New York City (73.1%), and Louisiana (75.0%).
Among the 22 sites that reported continuously, the prevalence of screening for postpartum depression rose significantly from 84.1% to 88.0% (P < .05), “with an average annual percentage point increase of 1.8%,” the authors wrote.
‘Missed opportunities’
“PRAMS responses are reported an average of 4 months postpartum, which suggests persistence of [depressive] symptoms,” the authors wrote.
Dr. Ko said that mental health conditions play a role in approximately 9% of pregnancy-related deaths and that not asking about depression represents “missed opportunities to potentially identify and treat women with depression.” The United States Preventive Services Task Force recommends screening all adults for depression, including women during pregnancy and the postpartum period, she added.
When asked what can be done to improve screening that has not already been tried, Dr. Ko said the CDC is currently evaluating a study called the Program in Support of Moms (PRISM), which “is designed to help obstetrics and gynecology practices address the significant public health issue of depression during and after pregnancy. PRISM aims to close gaps in health care delivery to ensure that women with depression during and after pregnancy receive the best treatment, which can result in improvement in their symptoms.”
Dr. Ko added that the Health Resources and Services Administration has funded seven states to begin “programs to support providers to screen, assess, refer, and treat pregnant and postpartum women for depression and other behavioral health conditions. States can use initiatives like Healthy Start, home visiting, and Title V Maternal and Child Health Services Block Grant programs as levers to improve screening and address maternal depression.
“Screening is just one part of addressing perinatal depression. Health care providers need to refer women to appropriate resources in order to get the proper diagnosis, treatment, and follow-up care for management of depression,” Dr. Ko concluded.
The authors disclosed no relevant financial relationships.
A version of this article originally appeared on Medscape.com.
Health care providers fail to ask one in five prenatal patients and one in eight postpartum patients about depression, according to the Centers for Disease Control and Prevention. Although the prevalence of screening has risen in recent years, many women could be suffering in silence.
“[U]ndetected and untreated perinatal depression can have negative health consequences for the mothers and their babies,” said coauthor Jean Y. Ko, PhD, from the division of reproductive health at the National Center for Chronic Disease Prevention and Health Promotion.
Dr. Ko and colleagues reported their findings in an article published in Morbidity and Mortality Weekly Report.
The researchers analyzed self-reported data on postpartum depressive symptoms (PDS) collected in 2018 by the Pregnancy Risk Assessment Monitoring System (PRAMS). Participants were stratified on the basis of location and maternal and infant characteristics, including age, race/ethnicity, and education level. Women who had recently given birth to one or more live infants answered questions about whether they had been screened by health care providers for depression during perinatal visits.
The prevalence of PDS among women from 31 PRAMS sites was 13.2%. States with lower prevalences included Illinois (9.7%), Massachusetts (10.3%), and Wisconsin (10.5%); states with higher prevalences included Mississippi (23.5%), West Virginia (19.4%), and Michigan (16.4%).
Some groups were at higher risk for PDS than others. The prevalence was greater than 20% among women who were aged 19 years or younger, were of American Indian or Alaska Native ethnicity, smoked during the perinatal period, experienced perinatal depression, or whose infant died after birth.
Depressive symptoms were also more common among women who received assistance from the Women, Infants, and Children program; were Medicaid beneficiaries at the time of delivery; smoked cigarettes during the last trimester of pregnancy; breastfed their infants for fewer than 8 weeks; or had experienced intimate partner violence while pregnant or before.
Small rise in screening
Overall, 79.1% of women said a health care provider had inquired about depression during the prenatal period. Prenatal screening for depression was lowest in Puerto Rico (50.7%), Mississippi (69.4%), Utah (69.5%), and Kentucky (69.5%) and was highest in Alaska (90.7%), Minnesota (90.6%), and Maine (90.5%).
Among 22 continuously reporting sites, the prevalence of prenatal depression screening rose significantly from 76.2% in 2016 to 79.3% in 2018 (P < .05) .
“It is unclear what might account for this small increase,” Dr. Ko said. “There may be additional factors, such as women may be becoming more comfortable reporting symptoms of depression. With continued awareness about the need to screen every pregnant and postpartum woman for depression, we can expect things to continue to improve.”
Overall, 90.1% of respondents reported a postpartum visit; of those, 87.4% said a health care provider had asked about depression during that visit.
Screening during the postpartum period was highest in Vermont (96.2%), Minnesota (95.9%), and Maine (95.5%) and was lowest in Puerto Rico (50.7%), New York City (73.1%), and Louisiana (75.0%).
Among the 22 sites that reported continuously, the prevalence of screening for postpartum depression rose significantly from 84.1% to 88.0% (P < .05), “with an average annual percentage point increase of 1.8%,” the authors wrote.
‘Missed opportunities’
“PRAMS responses are reported an average of 4 months postpartum, which suggests persistence of [depressive] symptoms,” the authors wrote.
Dr. Ko said that mental health conditions play a role in approximately 9% of pregnancy-related deaths and that not asking about depression represents “missed opportunities to potentially identify and treat women with depression.” The United States Preventive Services Task Force recommends screening all adults for depression, including women during pregnancy and the postpartum period, she added.
When asked what can be done to improve screening that has not already been tried, Dr. Ko said the CDC is currently evaluating a study called the Program in Support of Moms (PRISM), which “is designed to help obstetrics and gynecology practices address the significant public health issue of depression during and after pregnancy. PRISM aims to close gaps in health care delivery to ensure that women with depression during and after pregnancy receive the best treatment, which can result in improvement in their symptoms.”
Dr. Ko added that the Health Resources and Services Administration has funded seven states to begin “programs to support providers to screen, assess, refer, and treat pregnant and postpartum women for depression and other behavioral health conditions. States can use initiatives like Healthy Start, home visiting, and Title V Maternal and Child Health Services Block Grant programs as levers to improve screening and address maternal depression.
“Screening is just one part of addressing perinatal depression. Health care providers need to refer women to appropriate resources in order to get the proper diagnosis, treatment, and follow-up care for management of depression,” Dr. Ko concluded.
The authors disclosed no relevant financial relationships.
A version of this article originally appeared on Medscape.com.