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Berdazimer gel beats vehicle for molluscum contagiosum in phase 3 study
Treatment with .
Molluscum contagiosum (MC) remains a common infection that, despite being self-limiting, may persist for months or years, and is associated with quality of life concerns and the need for ongoing therapy, wrote John C. Browning, MD, of Texas Dermatology and Laser Specialists, San Antonio, and colleagues, who conducted the phase 3 randomized study.
The infection is most common in children aged 1-14 years, and treatment may be needed in part to avoid infecting peers and family members, they said. No treatments for molluscum are currently approved by the Food and Drug Administration.
In the study, which was published in JAMA Dermatology, the researchers randomized 444 patients to berdazimer gel 10.3% and 447 to a placebo gel, applied once daily in a thin layer on all MC lesions for 12 weeks. The study was conducted at 55 clinics across the United States between Sept. 1, 2020, and July 21, 2021. The mean age of the patients was about 6.5 years (range was 0.9-49 years), and about 85% were White. Participants had 3-70 raised MC lesions; those with sexually transmitted MC or MC in the periocular area were excluded. The primary endpoint was complete clearance of MC lesions after 12 weeks of treatment. At 12 weeks, significantly more patients treated with berdazimer gel achieved complete clearance than those on vehicle (32.4% vs. 19.7%; P < .001). A total of 64 (14.4%) patients in the berdazimer group discontinued treatment because of MC clearance, compared with 40 patients (8.9%) in the vehicle group.
Most adverse events were mild or moderate, and rates of adverse events resulting in treatment discontinuation were low overall for both groups; the most common adverse events were application-site pain and erythema, which were mostly mild. Overall, 4.1% of berdazimer-treated patients and 0.7% of placebo patients discontinued the study because of adverse events.
The study findings were limited by several factors, including the small number of patients in subgroups for race, ethnicity, and age; and the lack of data on patients with sexually transmitted MC and on concomitant use with other topical MC therapies, the researchers noted.
However, the results represent the largest randomized clinical trial of berdazimer 10.3% to date, and support its potential as a first-line therapy for MC patients aged 6 months and older, according to the authors. “Berdazimer is under consideration as a first in-class therapeutic agent for MC and may provide a topical prescription alternative to other therapies used for this highly contagious and psychosocially challenging skin condition,” they said.
Having a reliable, steroid-free, safe, and efficacious medication to treat molluscum in the pediatric population, as early as age 6 months, that can be used at home would “change the whole therapeutic paradigm,” one of the study authors, Adelaide Hebert, MD, said in an interview at the Society for Pediatric Dermatology annual meeting in July, where she presented phase 2 data on berdazimer gel. “This is a common problem and the rate of infections among siblings if it goes untreated is 41%. Affected kids have a sense of isolation; they don’t get invited to swimming parties.”
The lack of a safe and effective topical therapy “has been challenging,” added Dr. Hebert, professor of dermatology and pediatrics, and chief of pediatric dermatology at the University of Texas, Houston. She noted that treatments that have been used but have not been successful include imiquimod. “I’m not impressed with tretinoin,” although it is prescribed for MC, and the most common treatment prescribed by pediatricians for molluscum – mupirocin – is “usually not effective,” she said.
Another MC treatment in trials
Another investigative treatment for molluscum contagiosum, VP-102, a drug-device combination of cantharidin 0.7% administered through a single-use precision applicator, has been evaluated in phase 3 studies of patients with MC aged 2 years and older. The results of two phase 3 studies were published in 2020.
In May 2022, Verrica Pharmaceuticals, which is developing VP-102, announced that Food and Drug Administration approval had been delayed because of deficiencies identified at a contract manufacturing organization, and that the company was working with the agency to bring VP-102 to the market as soon as possible.
A step in the right direction
Although MC is self-resolving, cases last an average of 13.5 months, and “many families look to fast-forward their child’s experience with the infection,” Vikash S. Oza, MD, a pediatric dermatologist at New York University, New York, wrote in an editorial that accompanied the berdazimer study.
“To truly create a paradigm shift in the decision to treat MC, a therapeutic treatment would need to be developed that would lead to resolution of the infection over a short time frame (ideally, weeks) with minimal discomfort,” Dr. Oza noted. “Both VP-102 and berdazimer gel, 10.3%, have the potential to be the first-ever MC therapies approved by the U.S. Food and Drug Administration,” and families seeking to reduce MC in visible areas would welcome this option for a home therapy, he said.
However, Dr. Oza emphasized that potential barriers to widespread use of these therapies include whether the efficacy can be maintained in patients who fail to comply with daily application, and the ongoing need for office-based therapy to manage sexually transmitted MC in adults and periocular and perianal MC in children. The study was funded by Novan. Lead author Dr. Browning disclosed grants from Novan during the conduct of the study; Dr. Hebert reported grants from the University of Texas Health Science Center McGovern Medical School-Houston during the conduct of the study. Disclosures of other authors included having reported equity in Novan during the conduct of the study and receiving a grant from Novan. Dr. Oza had no financial conflicts to disclose.
Treatment with .
Molluscum contagiosum (MC) remains a common infection that, despite being self-limiting, may persist for months or years, and is associated with quality of life concerns and the need for ongoing therapy, wrote John C. Browning, MD, of Texas Dermatology and Laser Specialists, San Antonio, and colleagues, who conducted the phase 3 randomized study.
The infection is most common in children aged 1-14 years, and treatment may be needed in part to avoid infecting peers and family members, they said. No treatments for molluscum are currently approved by the Food and Drug Administration.
In the study, which was published in JAMA Dermatology, the researchers randomized 444 patients to berdazimer gel 10.3% and 447 to a placebo gel, applied once daily in a thin layer on all MC lesions for 12 weeks. The study was conducted at 55 clinics across the United States between Sept. 1, 2020, and July 21, 2021. The mean age of the patients was about 6.5 years (range was 0.9-49 years), and about 85% were White. Participants had 3-70 raised MC lesions; those with sexually transmitted MC or MC in the periocular area were excluded. The primary endpoint was complete clearance of MC lesions after 12 weeks of treatment. At 12 weeks, significantly more patients treated with berdazimer gel achieved complete clearance than those on vehicle (32.4% vs. 19.7%; P < .001). A total of 64 (14.4%) patients in the berdazimer group discontinued treatment because of MC clearance, compared with 40 patients (8.9%) in the vehicle group.
Most adverse events were mild or moderate, and rates of adverse events resulting in treatment discontinuation were low overall for both groups; the most common adverse events were application-site pain and erythema, which were mostly mild. Overall, 4.1% of berdazimer-treated patients and 0.7% of placebo patients discontinued the study because of adverse events.
The study findings were limited by several factors, including the small number of patients in subgroups for race, ethnicity, and age; and the lack of data on patients with sexually transmitted MC and on concomitant use with other topical MC therapies, the researchers noted.
However, the results represent the largest randomized clinical trial of berdazimer 10.3% to date, and support its potential as a first-line therapy for MC patients aged 6 months and older, according to the authors. “Berdazimer is under consideration as a first in-class therapeutic agent for MC and may provide a topical prescription alternative to other therapies used for this highly contagious and psychosocially challenging skin condition,” they said.
Having a reliable, steroid-free, safe, and efficacious medication to treat molluscum in the pediatric population, as early as age 6 months, that can be used at home would “change the whole therapeutic paradigm,” one of the study authors, Adelaide Hebert, MD, said in an interview at the Society for Pediatric Dermatology annual meeting in July, where she presented phase 2 data on berdazimer gel. “This is a common problem and the rate of infections among siblings if it goes untreated is 41%. Affected kids have a sense of isolation; they don’t get invited to swimming parties.”
The lack of a safe and effective topical therapy “has been challenging,” added Dr. Hebert, professor of dermatology and pediatrics, and chief of pediatric dermatology at the University of Texas, Houston. She noted that treatments that have been used but have not been successful include imiquimod. “I’m not impressed with tretinoin,” although it is prescribed for MC, and the most common treatment prescribed by pediatricians for molluscum – mupirocin – is “usually not effective,” she said.
Another MC treatment in trials
Another investigative treatment for molluscum contagiosum, VP-102, a drug-device combination of cantharidin 0.7% administered through a single-use precision applicator, has been evaluated in phase 3 studies of patients with MC aged 2 years and older. The results of two phase 3 studies were published in 2020.
In May 2022, Verrica Pharmaceuticals, which is developing VP-102, announced that Food and Drug Administration approval had been delayed because of deficiencies identified at a contract manufacturing organization, and that the company was working with the agency to bring VP-102 to the market as soon as possible.
A step in the right direction
Although MC is self-resolving, cases last an average of 13.5 months, and “many families look to fast-forward their child’s experience with the infection,” Vikash S. Oza, MD, a pediatric dermatologist at New York University, New York, wrote in an editorial that accompanied the berdazimer study.
“To truly create a paradigm shift in the decision to treat MC, a therapeutic treatment would need to be developed that would lead to resolution of the infection over a short time frame (ideally, weeks) with minimal discomfort,” Dr. Oza noted. “Both VP-102 and berdazimer gel, 10.3%, have the potential to be the first-ever MC therapies approved by the U.S. Food and Drug Administration,” and families seeking to reduce MC in visible areas would welcome this option for a home therapy, he said.
However, Dr. Oza emphasized that potential barriers to widespread use of these therapies include whether the efficacy can be maintained in patients who fail to comply with daily application, and the ongoing need for office-based therapy to manage sexually transmitted MC in adults and periocular and perianal MC in children. The study was funded by Novan. Lead author Dr. Browning disclosed grants from Novan during the conduct of the study; Dr. Hebert reported grants from the University of Texas Health Science Center McGovern Medical School-Houston during the conduct of the study. Disclosures of other authors included having reported equity in Novan during the conduct of the study and receiving a grant from Novan. Dr. Oza had no financial conflicts to disclose.
Treatment with .
Molluscum contagiosum (MC) remains a common infection that, despite being self-limiting, may persist for months or years, and is associated with quality of life concerns and the need for ongoing therapy, wrote John C. Browning, MD, of Texas Dermatology and Laser Specialists, San Antonio, and colleagues, who conducted the phase 3 randomized study.
The infection is most common in children aged 1-14 years, and treatment may be needed in part to avoid infecting peers and family members, they said. No treatments for molluscum are currently approved by the Food and Drug Administration.
In the study, which was published in JAMA Dermatology, the researchers randomized 444 patients to berdazimer gel 10.3% and 447 to a placebo gel, applied once daily in a thin layer on all MC lesions for 12 weeks. The study was conducted at 55 clinics across the United States between Sept. 1, 2020, and July 21, 2021. The mean age of the patients was about 6.5 years (range was 0.9-49 years), and about 85% were White. Participants had 3-70 raised MC lesions; those with sexually transmitted MC or MC in the periocular area were excluded. The primary endpoint was complete clearance of MC lesions after 12 weeks of treatment. At 12 weeks, significantly more patients treated with berdazimer gel achieved complete clearance than those on vehicle (32.4% vs. 19.7%; P < .001). A total of 64 (14.4%) patients in the berdazimer group discontinued treatment because of MC clearance, compared with 40 patients (8.9%) in the vehicle group.
Most adverse events were mild or moderate, and rates of adverse events resulting in treatment discontinuation were low overall for both groups; the most common adverse events were application-site pain and erythema, which were mostly mild. Overall, 4.1% of berdazimer-treated patients and 0.7% of placebo patients discontinued the study because of adverse events.
The study findings were limited by several factors, including the small number of patients in subgroups for race, ethnicity, and age; and the lack of data on patients with sexually transmitted MC and on concomitant use with other topical MC therapies, the researchers noted.
However, the results represent the largest randomized clinical trial of berdazimer 10.3% to date, and support its potential as a first-line therapy for MC patients aged 6 months and older, according to the authors. “Berdazimer is under consideration as a first in-class therapeutic agent for MC and may provide a topical prescription alternative to other therapies used for this highly contagious and psychosocially challenging skin condition,” they said.
Having a reliable, steroid-free, safe, and efficacious medication to treat molluscum in the pediatric population, as early as age 6 months, that can be used at home would “change the whole therapeutic paradigm,” one of the study authors, Adelaide Hebert, MD, said in an interview at the Society for Pediatric Dermatology annual meeting in July, where she presented phase 2 data on berdazimer gel. “This is a common problem and the rate of infections among siblings if it goes untreated is 41%. Affected kids have a sense of isolation; they don’t get invited to swimming parties.”
The lack of a safe and effective topical therapy “has been challenging,” added Dr. Hebert, professor of dermatology and pediatrics, and chief of pediatric dermatology at the University of Texas, Houston. She noted that treatments that have been used but have not been successful include imiquimod. “I’m not impressed with tretinoin,” although it is prescribed for MC, and the most common treatment prescribed by pediatricians for molluscum – mupirocin – is “usually not effective,” she said.
Another MC treatment in trials
Another investigative treatment for molluscum contagiosum, VP-102, a drug-device combination of cantharidin 0.7% administered through a single-use precision applicator, has been evaluated in phase 3 studies of patients with MC aged 2 years and older. The results of two phase 3 studies were published in 2020.
In May 2022, Verrica Pharmaceuticals, which is developing VP-102, announced that Food and Drug Administration approval had been delayed because of deficiencies identified at a contract manufacturing organization, and that the company was working with the agency to bring VP-102 to the market as soon as possible.
A step in the right direction
Although MC is self-resolving, cases last an average of 13.5 months, and “many families look to fast-forward their child’s experience with the infection,” Vikash S. Oza, MD, a pediatric dermatologist at New York University, New York, wrote in an editorial that accompanied the berdazimer study.
“To truly create a paradigm shift in the decision to treat MC, a therapeutic treatment would need to be developed that would lead to resolution of the infection over a short time frame (ideally, weeks) with minimal discomfort,” Dr. Oza noted. “Both VP-102 and berdazimer gel, 10.3%, have the potential to be the first-ever MC therapies approved by the U.S. Food and Drug Administration,” and families seeking to reduce MC in visible areas would welcome this option for a home therapy, he said.
However, Dr. Oza emphasized that potential barriers to widespread use of these therapies include whether the efficacy can be maintained in patients who fail to comply with daily application, and the ongoing need for office-based therapy to manage sexually transmitted MC in adults and periocular and perianal MC in children. The study was funded by Novan. Lead author Dr. Browning disclosed grants from Novan during the conduct of the study; Dr. Hebert reported grants from the University of Texas Health Science Center McGovern Medical School-Houston during the conduct of the study. Disclosures of other authors included having reported equity in Novan during the conduct of the study and receiving a grant from Novan. Dr. Oza had no financial conflicts to disclose.
FROM JAMA DERMATOLOGY
Moderate drinking shows more benefit for older vs. younger adults
The health risks and benefits of moderate alcohol consumption are complex and remain a hot topic of debate. The data suggest that small amounts of alcohol may reduce the risk of certain health outcomes over time, but increase the risk of others, wrote Dana Bryazka, MS, a researcher at the Institute for Health Metrics and Evaluation (IHME) at the University of Washington, Seattle, and colleagues, in a paper published in the Lancet.
“The amount of alcohol that minimizes health loss is likely to depend on the distribution of underlying causes of disease burden in a given population. Since this distribution varies widely by geography, age, sex, and time, the level of alcohol consumption associated with the lowest risk to health would depend on the age structure and disease composition of that population,” the researchers wrote.
“We estimate that 1.78 million people worldwide died due to alcohol use in 2020,” Ms. Bryazka said in an interview. “It is important that alcohol consumption guidelines and policies are updated to minimize this harm, particularly in the populations at greatest risk,” she said.
“Existing alcohol consumption guidelines frequently vary by sex, with higher consumption thresholds set for males compared to females. Interestingly, with the currently available data we do not see evidence that risk of alcohol use varies by sex,” she noted.
Methods and results
In the study, the researchers conducted a systematic analysis of burden-weighted dose-response relative risk curves across 22 health outcomes. They used disease rates from the Global Burden of Diseases, Injuries, and Risk Factors Study (GBD) 2020 for the years 1990-2020 for 21 regions, including 204 countries and territories. The data were analyzed by 5-year age group, sex, and year for individuals aged 15-95 years and older. The researchers estimated the theoretical minimum risk exposure level (TMREL) and nondrinker equivalent (NDE), meaning the amount of alcohol at which the health risk equals that of a nondrinker.
One standard drink was defined as 10 g of pure alcohol, equivalent to a small glass of red wine (100 mL or 3.4 fluid ounces) at 13% alcohol by volume, a can or bottle of beer (375 mL or 12 fluid ounces) at 3.5% alcohol by volume, or a shot of whiskey or other spirits (30 mL or 1.0 fluid ounces) at 40% alcohol by volume.
Overall, the TMREL was low regardless of age, sex, time, or geography, and varied from 0 to 1.87 standard drinks per day. However, it was lowest for males aged 15-39 years (0.136 drinks per day) and only slightly higher for females aged 15-39 (0.273), representing 1-2 tenths of a standard drink.
For adults aged 40 and older without any underlying health conditions, drinking a small amount of alcohol may provide some benefits, such as reducing the risk of ischemic heart disease, stroke, and diabetes, the researchers noted. In general, for individuals aged 40-64 years, TMRELs ranged from about half a standard drink per day (0.527 drinks for males and 0.562 standard drinks per day for females) to almost two standard drinks (1.69 standard drinks per day for males and 1.82 for females). For those older than 65 years, the TMRELs represented just over 3 standard drinks per day (3.19 for males and 3.51 for females). For individuals aged 40 years and older, the distribution of disease burden varied by region, but was J-shaped across all regions, the researchers noted.
The researchers also found that those individuals consuming harmful amounts of alcohol were most likely to be aged 15-39 (59.1%) and male (76.9%).
The study findings were limited by several factors including the observational design and lack of data on drinking patterns, such as binge drinking, the researchers noted. Other limitations include the lack of data reflecting patterns of alcohol consumption during the COVID-19 pandemic, and exclusion of outcomes often associated with alcohol use, such as depression, anxiety, and dementia, that might reduce estimates of TMREL and NDE.
However, the results add to the ongoing discussion of the relationship between moderate alcohol consumption and health, the researchers said.
“The findings of this study support the development of tailored guidelines and recommendations on alcohol consumption by age and across regions and highlight that existing low consumption thresholds are too high for younger populations in all regions,” they concluded.
Consider individual factors when counseling patients
The takeaway message for primary care is that alcohol consumed in moderation can reduce the risk of ischemic heart disease, stroke, and diabetes, Ms. Bryazka noted. “However, it also increases the risk of many cancers, intentional and unintentional injuries, and infectious diseases like tuberculosis,” she said. “Of these health outcomes, young people are most likely to experience injuries, and as a result, we find that there are significant health risks associated with consuming alcohol for young people. Among older individuals, the relative proportions of these outcomes vary by geography, and so do the risks associated with consuming alcohol,” she explained.
“Importantly, our analysis was conducted at the population level; when evaluating risk at the individual level, it is also important to consider other factors such as the presence of comorbidities and interactions between alcohol and medications,” she emphasized.
Health and alcohol interaction is complicated
“These findings seemingly contradict a previous [Global Burden of Diseases, Injuries, and Risk Factors Study] estimate published in The Lancet, which emphasized that any alcohol use, regardless of amount, leads to health loss across populations,” wrote Robyn Burton, PhD, and Nick Sheron, MD, both of King’s College, London, in an accompanying comment.
However, the novel methods of weighting relative risk curves according to levels of underlying disease drive the difference in results, along with disaggregated estimates by age, sex, and region, they said.
“Across most geographical regions in this latest analysis, injuries accounted for most alcohol-related harm in younger age groups. This led to a minimum risk level of zero, or very close to zero, among individuals aged 15-39 years across all geographical regions,” which is lower than the level for older adults because of the shift in alcohol-related disease burden towards cardiovascular disease and cancers, they said. “This highlights the need to consider existing rates of disease in a population when trying to determine the total harm posed by alcohol,” the commentators wrote.
In an additional commentary, Tony Rao, MD, a visiting clinical research fellow in psychiatry at King’s College, London, noted that “the elephant in the room with this study is the interpretation of risk based on outcomes for cardiovascular disease – particularly in older people. We know that any purported health benefits from alcohol on the heart and circulation are balanced out by the increased risk from other conditions such as cancer, liver disease, and mental disorders such as depression and dementia,” Dr. Rao said. “If we are to simply draw the conclusion that older people should continue or start drinking small amounts because it protects against diseases affecting heart and circulation – which still remains controversial – other lifestyle changes or the use of drugs targeted at individual cardiovascular disorders seem like a less harmful way of improving health and wellbeing.”
Data can guide clinical practice
No previous study has examined the effect of the theoretical minimum risk of alcohol consumption by geography, age, sex, and time in the context of background disease rates, said Noel Deep, MD, in an interview.
“This study enabled the researchers to quantify the proportion of the population that consumed alcohol in amounts that exceeded the thresholds by location, age, sex, and year, and this can serve as a guide in our efforts to target the control of alcohol intake by individuals,” said Dr. Deep, a general internist in private practice in Antigo, Wisc. He also serves as chief medical officer and a staff physician at Aspirus Langlade Hospital in Antigo.
The first take-home message for clinicians is that even low levels of alcohol consumption can have deleterious effects on the health of patients, and patients should be advised accordingly based on the prevalence of diseases in that community and geographic area, Dr. Deep said. “Secondly, clinicians should also consider the risk of alcohol consumption on all forms of health impacts in a given population rather than just focusing on alcohol-related health conditions,” he added.
“This study provides us with the data to tailor our efforts in educating the clinicians and the public about the relationship between alcohol consumption and disease outcomes based on the observed disease rates in each population,” Dr. Deep explained. “The data should provide another reason for physicians to advise their younger patients, especially the younger males, to avoid or minimize alcohol use,” he said. The data also can help clinicians formulate public health messaging and community education to reduce harmful alcohol use, he added.
As for additional research, Dr. Deep said he would like to see data on the difference in the health-related effects of alcohol in binge-drinkers vs. those who regularly consume alcohol on a daily basis. “It would probably also be helpful to figure out what type of alcohol is being studied and the quality of the alcohol,” he said.
The study was supported by the Bill and Melinda Gates Foundation. Ms. Bryazka and colleagues had no financial conflicts to disclose. Dr. Burton disclosed serving as a consultant to the World Health Organization European Office for the Prevention and Control of Noncommunicable Diseases. Dr. Sheron had no financial conflicts to disclose. Dr. Deep had no financial conflicts to disclose, but serves on the Editorial Advisory Board of Internal Medicine News.
The study was supported by the Bill and Melinda Gates Foundation.
The health risks and benefits of moderate alcohol consumption are complex and remain a hot topic of debate. The data suggest that small amounts of alcohol may reduce the risk of certain health outcomes over time, but increase the risk of others, wrote Dana Bryazka, MS, a researcher at the Institute for Health Metrics and Evaluation (IHME) at the University of Washington, Seattle, and colleagues, in a paper published in the Lancet.
“The amount of alcohol that minimizes health loss is likely to depend on the distribution of underlying causes of disease burden in a given population. Since this distribution varies widely by geography, age, sex, and time, the level of alcohol consumption associated with the lowest risk to health would depend on the age structure and disease composition of that population,” the researchers wrote.
“We estimate that 1.78 million people worldwide died due to alcohol use in 2020,” Ms. Bryazka said in an interview. “It is important that alcohol consumption guidelines and policies are updated to minimize this harm, particularly in the populations at greatest risk,” she said.
“Existing alcohol consumption guidelines frequently vary by sex, with higher consumption thresholds set for males compared to females. Interestingly, with the currently available data we do not see evidence that risk of alcohol use varies by sex,” she noted.
Methods and results
In the study, the researchers conducted a systematic analysis of burden-weighted dose-response relative risk curves across 22 health outcomes. They used disease rates from the Global Burden of Diseases, Injuries, and Risk Factors Study (GBD) 2020 for the years 1990-2020 for 21 regions, including 204 countries and territories. The data were analyzed by 5-year age group, sex, and year for individuals aged 15-95 years and older. The researchers estimated the theoretical minimum risk exposure level (TMREL) and nondrinker equivalent (NDE), meaning the amount of alcohol at which the health risk equals that of a nondrinker.
One standard drink was defined as 10 g of pure alcohol, equivalent to a small glass of red wine (100 mL or 3.4 fluid ounces) at 13% alcohol by volume, a can or bottle of beer (375 mL or 12 fluid ounces) at 3.5% alcohol by volume, or a shot of whiskey or other spirits (30 mL or 1.0 fluid ounces) at 40% alcohol by volume.
Overall, the TMREL was low regardless of age, sex, time, or geography, and varied from 0 to 1.87 standard drinks per day. However, it was lowest for males aged 15-39 years (0.136 drinks per day) and only slightly higher for females aged 15-39 (0.273), representing 1-2 tenths of a standard drink.
For adults aged 40 and older without any underlying health conditions, drinking a small amount of alcohol may provide some benefits, such as reducing the risk of ischemic heart disease, stroke, and diabetes, the researchers noted. In general, for individuals aged 40-64 years, TMRELs ranged from about half a standard drink per day (0.527 drinks for males and 0.562 standard drinks per day for females) to almost two standard drinks (1.69 standard drinks per day for males and 1.82 for females). For those older than 65 years, the TMRELs represented just over 3 standard drinks per day (3.19 for males and 3.51 for females). For individuals aged 40 years and older, the distribution of disease burden varied by region, but was J-shaped across all regions, the researchers noted.
The researchers also found that those individuals consuming harmful amounts of alcohol were most likely to be aged 15-39 (59.1%) and male (76.9%).
The study findings were limited by several factors including the observational design and lack of data on drinking patterns, such as binge drinking, the researchers noted. Other limitations include the lack of data reflecting patterns of alcohol consumption during the COVID-19 pandemic, and exclusion of outcomes often associated with alcohol use, such as depression, anxiety, and dementia, that might reduce estimates of TMREL and NDE.
However, the results add to the ongoing discussion of the relationship between moderate alcohol consumption and health, the researchers said.
“The findings of this study support the development of tailored guidelines and recommendations on alcohol consumption by age and across regions and highlight that existing low consumption thresholds are too high for younger populations in all regions,” they concluded.
Consider individual factors when counseling patients
The takeaway message for primary care is that alcohol consumed in moderation can reduce the risk of ischemic heart disease, stroke, and diabetes, Ms. Bryazka noted. “However, it also increases the risk of many cancers, intentional and unintentional injuries, and infectious diseases like tuberculosis,” she said. “Of these health outcomes, young people are most likely to experience injuries, and as a result, we find that there are significant health risks associated with consuming alcohol for young people. Among older individuals, the relative proportions of these outcomes vary by geography, and so do the risks associated with consuming alcohol,” she explained.
“Importantly, our analysis was conducted at the population level; when evaluating risk at the individual level, it is also important to consider other factors such as the presence of comorbidities and interactions between alcohol and medications,” she emphasized.
Health and alcohol interaction is complicated
“These findings seemingly contradict a previous [Global Burden of Diseases, Injuries, and Risk Factors Study] estimate published in The Lancet, which emphasized that any alcohol use, regardless of amount, leads to health loss across populations,” wrote Robyn Burton, PhD, and Nick Sheron, MD, both of King’s College, London, in an accompanying comment.
However, the novel methods of weighting relative risk curves according to levels of underlying disease drive the difference in results, along with disaggregated estimates by age, sex, and region, they said.
“Across most geographical regions in this latest analysis, injuries accounted for most alcohol-related harm in younger age groups. This led to a minimum risk level of zero, or very close to zero, among individuals aged 15-39 years across all geographical regions,” which is lower than the level for older adults because of the shift in alcohol-related disease burden towards cardiovascular disease and cancers, they said. “This highlights the need to consider existing rates of disease in a population when trying to determine the total harm posed by alcohol,” the commentators wrote.
In an additional commentary, Tony Rao, MD, a visiting clinical research fellow in psychiatry at King’s College, London, noted that “the elephant in the room with this study is the interpretation of risk based on outcomes for cardiovascular disease – particularly in older people. We know that any purported health benefits from alcohol on the heart and circulation are balanced out by the increased risk from other conditions such as cancer, liver disease, and mental disorders such as depression and dementia,” Dr. Rao said. “If we are to simply draw the conclusion that older people should continue or start drinking small amounts because it protects against diseases affecting heart and circulation – which still remains controversial – other lifestyle changes or the use of drugs targeted at individual cardiovascular disorders seem like a less harmful way of improving health and wellbeing.”
Data can guide clinical practice
No previous study has examined the effect of the theoretical minimum risk of alcohol consumption by geography, age, sex, and time in the context of background disease rates, said Noel Deep, MD, in an interview.
“This study enabled the researchers to quantify the proportion of the population that consumed alcohol in amounts that exceeded the thresholds by location, age, sex, and year, and this can serve as a guide in our efforts to target the control of alcohol intake by individuals,” said Dr. Deep, a general internist in private practice in Antigo, Wisc. He also serves as chief medical officer and a staff physician at Aspirus Langlade Hospital in Antigo.
The first take-home message for clinicians is that even low levels of alcohol consumption can have deleterious effects on the health of patients, and patients should be advised accordingly based on the prevalence of diseases in that community and geographic area, Dr. Deep said. “Secondly, clinicians should also consider the risk of alcohol consumption on all forms of health impacts in a given population rather than just focusing on alcohol-related health conditions,” he added.
“This study provides us with the data to tailor our efforts in educating the clinicians and the public about the relationship between alcohol consumption and disease outcomes based on the observed disease rates in each population,” Dr. Deep explained. “The data should provide another reason for physicians to advise their younger patients, especially the younger males, to avoid or minimize alcohol use,” he said. The data also can help clinicians formulate public health messaging and community education to reduce harmful alcohol use, he added.
As for additional research, Dr. Deep said he would like to see data on the difference in the health-related effects of alcohol in binge-drinkers vs. those who regularly consume alcohol on a daily basis. “It would probably also be helpful to figure out what type of alcohol is being studied and the quality of the alcohol,” he said.
The study was supported by the Bill and Melinda Gates Foundation. Ms. Bryazka and colleagues had no financial conflicts to disclose. Dr. Burton disclosed serving as a consultant to the World Health Organization European Office for the Prevention and Control of Noncommunicable Diseases. Dr. Sheron had no financial conflicts to disclose. Dr. Deep had no financial conflicts to disclose, but serves on the Editorial Advisory Board of Internal Medicine News.
The study was supported by the Bill and Melinda Gates Foundation.
The health risks and benefits of moderate alcohol consumption are complex and remain a hot topic of debate. The data suggest that small amounts of alcohol may reduce the risk of certain health outcomes over time, but increase the risk of others, wrote Dana Bryazka, MS, a researcher at the Institute for Health Metrics and Evaluation (IHME) at the University of Washington, Seattle, and colleagues, in a paper published in the Lancet.
“The amount of alcohol that minimizes health loss is likely to depend on the distribution of underlying causes of disease burden in a given population. Since this distribution varies widely by geography, age, sex, and time, the level of alcohol consumption associated with the lowest risk to health would depend on the age structure and disease composition of that population,” the researchers wrote.
“We estimate that 1.78 million people worldwide died due to alcohol use in 2020,” Ms. Bryazka said in an interview. “It is important that alcohol consumption guidelines and policies are updated to minimize this harm, particularly in the populations at greatest risk,” she said.
“Existing alcohol consumption guidelines frequently vary by sex, with higher consumption thresholds set for males compared to females. Interestingly, with the currently available data we do not see evidence that risk of alcohol use varies by sex,” she noted.
Methods and results
In the study, the researchers conducted a systematic analysis of burden-weighted dose-response relative risk curves across 22 health outcomes. They used disease rates from the Global Burden of Diseases, Injuries, and Risk Factors Study (GBD) 2020 for the years 1990-2020 for 21 regions, including 204 countries and territories. The data were analyzed by 5-year age group, sex, and year for individuals aged 15-95 years and older. The researchers estimated the theoretical minimum risk exposure level (TMREL) and nondrinker equivalent (NDE), meaning the amount of alcohol at which the health risk equals that of a nondrinker.
One standard drink was defined as 10 g of pure alcohol, equivalent to a small glass of red wine (100 mL or 3.4 fluid ounces) at 13% alcohol by volume, a can or bottle of beer (375 mL or 12 fluid ounces) at 3.5% alcohol by volume, or a shot of whiskey or other spirits (30 mL or 1.0 fluid ounces) at 40% alcohol by volume.
Overall, the TMREL was low regardless of age, sex, time, or geography, and varied from 0 to 1.87 standard drinks per day. However, it was lowest for males aged 15-39 years (0.136 drinks per day) and only slightly higher for females aged 15-39 (0.273), representing 1-2 tenths of a standard drink.
For adults aged 40 and older without any underlying health conditions, drinking a small amount of alcohol may provide some benefits, such as reducing the risk of ischemic heart disease, stroke, and diabetes, the researchers noted. In general, for individuals aged 40-64 years, TMRELs ranged from about half a standard drink per day (0.527 drinks for males and 0.562 standard drinks per day for females) to almost two standard drinks (1.69 standard drinks per day for males and 1.82 for females). For those older than 65 years, the TMRELs represented just over 3 standard drinks per day (3.19 for males and 3.51 for females). For individuals aged 40 years and older, the distribution of disease burden varied by region, but was J-shaped across all regions, the researchers noted.
The researchers also found that those individuals consuming harmful amounts of alcohol were most likely to be aged 15-39 (59.1%) and male (76.9%).
The study findings were limited by several factors including the observational design and lack of data on drinking patterns, such as binge drinking, the researchers noted. Other limitations include the lack of data reflecting patterns of alcohol consumption during the COVID-19 pandemic, and exclusion of outcomes often associated with alcohol use, such as depression, anxiety, and dementia, that might reduce estimates of TMREL and NDE.
However, the results add to the ongoing discussion of the relationship between moderate alcohol consumption and health, the researchers said.
“The findings of this study support the development of tailored guidelines and recommendations on alcohol consumption by age and across regions and highlight that existing low consumption thresholds are too high for younger populations in all regions,” they concluded.
Consider individual factors when counseling patients
The takeaway message for primary care is that alcohol consumed in moderation can reduce the risk of ischemic heart disease, stroke, and diabetes, Ms. Bryazka noted. “However, it also increases the risk of many cancers, intentional and unintentional injuries, and infectious diseases like tuberculosis,” she said. “Of these health outcomes, young people are most likely to experience injuries, and as a result, we find that there are significant health risks associated with consuming alcohol for young people. Among older individuals, the relative proportions of these outcomes vary by geography, and so do the risks associated with consuming alcohol,” she explained.
“Importantly, our analysis was conducted at the population level; when evaluating risk at the individual level, it is also important to consider other factors such as the presence of comorbidities and interactions between alcohol and medications,” she emphasized.
Health and alcohol interaction is complicated
“These findings seemingly contradict a previous [Global Burden of Diseases, Injuries, and Risk Factors Study] estimate published in The Lancet, which emphasized that any alcohol use, regardless of amount, leads to health loss across populations,” wrote Robyn Burton, PhD, and Nick Sheron, MD, both of King’s College, London, in an accompanying comment.
However, the novel methods of weighting relative risk curves according to levels of underlying disease drive the difference in results, along with disaggregated estimates by age, sex, and region, they said.
“Across most geographical regions in this latest analysis, injuries accounted for most alcohol-related harm in younger age groups. This led to a minimum risk level of zero, or very close to zero, among individuals aged 15-39 years across all geographical regions,” which is lower than the level for older adults because of the shift in alcohol-related disease burden towards cardiovascular disease and cancers, they said. “This highlights the need to consider existing rates of disease in a population when trying to determine the total harm posed by alcohol,” the commentators wrote.
In an additional commentary, Tony Rao, MD, a visiting clinical research fellow in psychiatry at King’s College, London, noted that “the elephant in the room with this study is the interpretation of risk based on outcomes for cardiovascular disease – particularly in older people. We know that any purported health benefits from alcohol on the heart and circulation are balanced out by the increased risk from other conditions such as cancer, liver disease, and mental disorders such as depression and dementia,” Dr. Rao said. “If we are to simply draw the conclusion that older people should continue or start drinking small amounts because it protects against diseases affecting heart and circulation – which still remains controversial – other lifestyle changes or the use of drugs targeted at individual cardiovascular disorders seem like a less harmful way of improving health and wellbeing.”
Data can guide clinical practice
No previous study has examined the effect of the theoretical minimum risk of alcohol consumption by geography, age, sex, and time in the context of background disease rates, said Noel Deep, MD, in an interview.
“This study enabled the researchers to quantify the proportion of the population that consumed alcohol in amounts that exceeded the thresholds by location, age, sex, and year, and this can serve as a guide in our efforts to target the control of alcohol intake by individuals,” said Dr. Deep, a general internist in private practice in Antigo, Wisc. He also serves as chief medical officer and a staff physician at Aspirus Langlade Hospital in Antigo.
The first take-home message for clinicians is that even low levels of alcohol consumption can have deleterious effects on the health of patients, and patients should be advised accordingly based on the prevalence of diseases in that community and geographic area, Dr. Deep said. “Secondly, clinicians should also consider the risk of alcohol consumption on all forms of health impacts in a given population rather than just focusing on alcohol-related health conditions,” he added.
“This study provides us with the data to tailor our efforts in educating the clinicians and the public about the relationship between alcohol consumption and disease outcomes based on the observed disease rates in each population,” Dr. Deep explained. “The data should provide another reason for physicians to advise their younger patients, especially the younger males, to avoid or minimize alcohol use,” he said. The data also can help clinicians formulate public health messaging and community education to reduce harmful alcohol use, he added.
As for additional research, Dr. Deep said he would like to see data on the difference in the health-related effects of alcohol in binge-drinkers vs. those who regularly consume alcohol on a daily basis. “It would probably also be helpful to figure out what type of alcohol is being studied and the quality of the alcohol,” he said.
The study was supported by the Bill and Melinda Gates Foundation. Ms. Bryazka and colleagues had no financial conflicts to disclose. Dr. Burton disclosed serving as a consultant to the World Health Organization European Office for the Prevention and Control of Noncommunicable Diseases. Dr. Sheron had no financial conflicts to disclose. Dr. Deep had no financial conflicts to disclose, but serves on the Editorial Advisory Board of Internal Medicine News.
The study was supported by the Bill and Melinda Gates Foundation.
FROM THE LANCET
Inflammatory profiles impact major depressive disorder
Early onset of disease in patients with major depressive disorder may be linked to a specific inflammatory profile, based on data from 234 individuals.
Major depressive disorder (MDD) remains common, and evidence suggests that it is increasing among younger individuals, but data on early-onset MDD in adults are limited, Ana Paula Anzolin, a graduate student at the Universidade Federal do Rio Grande do Sul, Porto Alegre, Brazil, and colleagues wrote.
Although previous studies have shown abnormal cytokine production in patients with MDD, the impact of inflammation on MDD and disease onset and progression remains unclear, they said.
In a study published in Psychiatry Research, the authors identified outpatients aged 18-85 years with confirmed MDD and scores of at least 8 on the HAM-D scale who were undergoing treatment at a single center. Early onset was defined as a diagnosis of MDD before age 30 years (99 patients) and late onset was defined as a diagnosis at age 30 years and older (135 patients). The researchers measured levels of interleukin-6, IL-1 beta, IL-10, and tumor necrosis factor alpha (TNF-alpha).
Overall, the level of cytokine profiles in early- versus late-onset disease was significantly higher for IL-1B and TNF-alpha (P < .001 for both). The significant difference between early- and late-onset disease remained regardless of comorbidity with autoimmune diseases, the researchers noted.
IL-6 levels were higher in the early-onset group and IL-10 levels were higher in the late-onset group, but these differences were not significant.
the researchers wrote.
The results also support findings from previous studies that suggest a divergence between early- and late adult–onset depression, they said. More research on early-onset MDD in adults is needed, as these patients tend to have more severe symptoms, more medical and psychiatric comorbidities, and an increased risk of depressive episodes and suicide attempts.
The study findings were limited by several factors including the lack of a control group, the retrospective assessment of disease onset, and the limited cytokines studied, which do not reflect changes in the entire immune network response, the researchers noted.
However, the study is the first known to examine the association of serum cytokines and early- and late-onset MDD in adults, and the results support the use of IL-1B and TNF-alpha as potential treatment targets in the development of new therapies for MDD, they concluded.
The study was supported by the Fundo de Incentivo à Pesquisa – Hospital de Clínicas de Porto Alegre, the Conselho Nacional de Desenvolvimento Científico e Tecnológico, and the Coordenação de Aperfeiçoamento de Pessoal de Nível Superior. The researchers had no financial conflicts to disclose.
Early onset of disease in patients with major depressive disorder may be linked to a specific inflammatory profile, based on data from 234 individuals.
Major depressive disorder (MDD) remains common, and evidence suggests that it is increasing among younger individuals, but data on early-onset MDD in adults are limited, Ana Paula Anzolin, a graduate student at the Universidade Federal do Rio Grande do Sul, Porto Alegre, Brazil, and colleagues wrote.
Although previous studies have shown abnormal cytokine production in patients with MDD, the impact of inflammation on MDD and disease onset and progression remains unclear, they said.
In a study published in Psychiatry Research, the authors identified outpatients aged 18-85 years with confirmed MDD and scores of at least 8 on the HAM-D scale who were undergoing treatment at a single center. Early onset was defined as a diagnosis of MDD before age 30 years (99 patients) and late onset was defined as a diagnosis at age 30 years and older (135 patients). The researchers measured levels of interleukin-6, IL-1 beta, IL-10, and tumor necrosis factor alpha (TNF-alpha).
Overall, the level of cytokine profiles in early- versus late-onset disease was significantly higher for IL-1B and TNF-alpha (P < .001 for both). The significant difference between early- and late-onset disease remained regardless of comorbidity with autoimmune diseases, the researchers noted.
IL-6 levels were higher in the early-onset group and IL-10 levels were higher in the late-onset group, but these differences were not significant.
the researchers wrote.
The results also support findings from previous studies that suggest a divergence between early- and late adult–onset depression, they said. More research on early-onset MDD in adults is needed, as these patients tend to have more severe symptoms, more medical and psychiatric comorbidities, and an increased risk of depressive episodes and suicide attempts.
The study findings were limited by several factors including the lack of a control group, the retrospective assessment of disease onset, and the limited cytokines studied, which do not reflect changes in the entire immune network response, the researchers noted.
However, the study is the first known to examine the association of serum cytokines and early- and late-onset MDD in adults, and the results support the use of IL-1B and TNF-alpha as potential treatment targets in the development of new therapies for MDD, they concluded.
The study was supported by the Fundo de Incentivo à Pesquisa – Hospital de Clínicas de Porto Alegre, the Conselho Nacional de Desenvolvimento Científico e Tecnológico, and the Coordenação de Aperfeiçoamento de Pessoal de Nível Superior. The researchers had no financial conflicts to disclose.
Early onset of disease in patients with major depressive disorder may be linked to a specific inflammatory profile, based on data from 234 individuals.
Major depressive disorder (MDD) remains common, and evidence suggests that it is increasing among younger individuals, but data on early-onset MDD in adults are limited, Ana Paula Anzolin, a graduate student at the Universidade Federal do Rio Grande do Sul, Porto Alegre, Brazil, and colleagues wrote.
Although previous studies have shown abnormal cytokine production in patients with MDD, the impact of inflammation on MDD and disease onset and progression remains unclear, they said.
In a study published in Psychiatry Research, the authors identified outpatients aged 18-85 years with confirmed MDD and scores of at least 8 on the HAM-D scale who were undergoing treatment at a single center. Early onset was defined as a diagnosis of MDD before age 30 years (99 patients) and late onset was defined as a diagnosis at age 30 years and older (135 patients). The researchers measured levels of interleukin-6, IL-1 beta, IL-10, and tumor necrosis factor alpha (TNF-alpha).
Overall, the level of cytokine profiles in early- versus late-onset disease was significantly higher for IL-1B and TNF-alpha (P < .001 for both). The significant difference between early- and late-onset disease remained regardless of comorbidity with autoimmune diseases, the researchers noted.
IL-6 levels were higher in the early-onset group and IL-10 levels were higher in the late-onset group, but these differences were not significant.
the researchers wrote.
The results also support findings from previous studies that suggest a divergence between early- and late adult–onset depression, they said. More research on early-onset MDD in adults is needed, as these patients tend to have more severe symptoms, more medical and psychiatric comorbidities, and an increased risk of depressive episodes and suicide attempts.
The study findings were limited by several factors including the lack of a control group, the retrospective assessment of disease onset, and the limited cytokines studied, which do not reflect changes in the entire immune network response, the researchers noted.
However, the study is the first known to examine the association of serum cytokines and early- and late-onset MDD in adults, and the results support the use of IL-1B and TNF-alpha as potential treatment targets in the development of new therapies for MDD, they concluded.
The study was supported by the Fundo de Incentivo à Pesquisa – Hospital de Clínicas de Porto Alegre, the Conselho Nacional de Desenvolvimento Científico e Tecnológico, and the Coordenação de Aperfeiçoamento de Pessoal de Nível Superior. The researchers had no financial conflicts to disclose.
FROM PSYCHIATRY RESEARCH
Uveitis in juvenile arthritis patients persists into midlife
Active uveitis remained in 43.4% of juvenile idiopathic arthritis (JIA) patients up to 40 years after a diagnosis, based on data from 30 individuals.
Uveitis occurs in approximately 10%-20% of patients with JIA, but data on the long-term activity and prevalence are limited, although previous studies suggest that uveitis can persist into adulthood, wrote Dr. Angelika Skarin of Skåne University in Lund, Sweden, and colleagues.
In a study published in Pediatric Rheumatology, the researchers reviewed ophthalmic records from 30 JIA patients at a mean of 40.7 years after uveitis onset. They compared these records to data collected from the same patient population at a mean of 7.2 and 24.0 years after onset. In the previous follow-up studies, 49% of the patients had active uveitis at 24 years, and the prevalence of cataracts and glaucoma increased between the 7-year and 24-year assessments.
In the current study, 43.4% of the population had active uveitis at the 40-year follow-up, which corresponded to 23.6% of the original study cohort. The mean age of the participants overall was 46.9 years, the mean duration of joint disease was 42.99 years, and the mean time from onset of uveitis was 40.7 years.
In addition, 66.6% of the patients in the current study had cataracts or had undergone cataract surgery in one or both eyes, and 40.0% had glaucoma.
By the time of the current study, of the original cohort of 55 individuals, 11 were deceased; rheumatic disease was declared the main cause in four patients and a contributing factor in three others.
Potential drivers of the earliest cases of glaucoma and ocular hypertension (G/OH) include increased intraocular pressure as a result of topical corticosteroid treatment, the researchers noted in their discussion. However, G/OH occurring later than the 7-year follow-up was “more likely to be the type observed in many patients with long-standing chronic uveitis, where a gradual increase in intraocular pressure is assumed to be caused by impaired aqueous outflow,” they said.
Only 4 of the 30 patients did not have regular ophthalmology visits, which suggests a study population with ocular symptoms or concerns about their eyesight, the researchers wrote. “The fact that 13% of our original cohort were reported to have severe visual impairment or worse in both eyes at any of the three follow-ups is noteworthy,” compared to reports of visual impairment of less than 0.5% in a German study in the general population for similar ages.
The findings were limited by several factors, including the retrospective design, small study population, and lack of data on 25 of the original 55-member study cohort, which may reduce the reliability of the current study, the researchers noted. However, the results reflect data from previous studies and support the need for JIA patients to continue regular ophthalmic checkups throughout life, they concluded.
The study was supported by Stiftelsen för Synskadade i f.d. Malmöhus län, Sweden, Skånes Universitetssjukhus Stiftelser och Donationer, Ögonfonden, and the Swedish Society of Medicine. The researchers had no financial conflicts to disclose.
Active uveitis remained in 43.4% of juvenile idiopathic arthritis (JIA) patients up to 40 years after a diagnosis, based on data from 30 individuals.
Uveitis occurs in approximately 10%-20% of patients with JIA, but data on the long-term activity and prevalence are limited, although previous studies suggest that uveitis can persist into adulthood, wrote Dr. Angelika Skarin of Skåne University in Lund, Sweden, and colleagues.
In a study published in Pediatric Rheumatology, the researchers reviewed ophthalmic records from 30 JIA patients at a mean of 40.7 years after uveitis onset. They compared these records to data collected from the same patient population at a mean of 7.2 and 24.0 years after onset. In the previous follow-up studies, 49% of the patients had active uveitis at 24 years, and the prevalence of cataracts and glaucoma increased between the 7-year and 24-year assessments.
In the current study, 43.4% of the population had active uveitis at the 40-year follow-up, which corresponded to 23.6% of the original study cohort. The mean age of the participants overall was 46.9 years, the mean duration of joint disease was 42.99 years, and the mean time from onset of uveitis was 40.7 years.
In addition, 66.6% of the patients in the current study had cataracts or had undergone cataract surgery in one or both eyes, and 40.0% had glaucoma.
By the time of the current study, of the original cohort of 55 individuals, 11 were deceased; rheumatic disease was declared the main cause in four patients and a contributing factor in three others.
Potential drivers of the earliest cases of glaucoma and ocular hypertension (G/OH) include increased intraocular pressure as a result of topical corticosteroid treatment, the researchers noted in their discussion. However, G/OH occurring later than the 7-year follow-up was “more likely to be the type observed in many patients with long-standing chronic uveitis, where a gradual increase in intraocular pressure is assumed to be caused by impaired aqueous outflow,” they said.
Only 4 of the 30 patients did not have regular ophthalmology visits, which suggests a study population with ocular symptoms or concerns about their eyesight, the researchers wrote. “The fact that 13% of our original cohort were reported to have severe visual impairment or worse in both eyes at any of the three follow-ups is noteworthy,” compared to reports of visual impairment of less than 0.5% in a German study in the general population for similar ages.
The findings were limited by several factors, including the retrospective design, small study population, and lack of data on 25 of the original 55-member study cohort, which may reduce the reliability of the current study, the researchers noted. However, the results reflect data from previous studies and support the need for JIA patients to continue regular ophthalmic checkups throughout life, they concluded.
The study was supported by Stiftelsen för Synskadade i f.d. Malmöhus län, Sweden, Skånes Universitetssjukhus Stiftelser och Donationer, Ögonfonden, and the Swedish Society of Medicine. The researchers had no financial conflicts to disclose.
Active uveitis remained in 43.4% of juvenile idiopathic arthritis (JIA) patients up to 40 years after a diagnosis, based on data from 30 individuals.
Uveitis occurs in approximately 10%-20% of patients with JIA, but data on the long-term activity and prevalence are limited, although previous studies suggest that uveitis can persist into adulthood, wrote Dr. Angelika Skarin of Skåne University in Lund, Sweden, and colleagues.
In a study published in Pediatric Rheumatology, the researchers reviewed ophthalmic records from 30 JIA patients at a mean of 40.7 years after uveitis onset. They compared these records to data collected from the same patient population at a mean of 7.2 and 24.0 years after onset. In the previous follow-up studies, 49% of the patients had active uveitis at 24 years, and the prevalence of cataracts and glaucoma increased between the 7-year and 24-year assessments.
In the current study, 43.4% of the population had active uveitis at the 40-year follow-up, which corresponded to 23.6% of the original study cohort. The mean age of the participants overall was 46.9 years, the mean duration of joint disease was 42.99 years, and the mean time from onset of uveitis was 40.7 years.
In addition, 66.6% of the patients in the current study had cataracts or had undergone cataract surgery in one or both eyes, and 40.0% had glaucoma.
By the time of the current study, of the original cohort of 55 individuals, 11 were deceased; rheumatic disease was declared the main cause in four patients and a contributing factor in three others.
Potential drivers of the earliest cases of glaucoma and ocular hypertension (G/OH) include increased intraocular pressure as a result of topical corticosteroid treatment, the researchers noted in their discussion. However, G/OH occurring later than the 7-year follow-up was “more likely to be the type observed in many patients with long-standing chronic uveitis, where a gradual increase in intraocular pressure is assumed to be caused by impaired aqueous outflow,” they said.
Only 4 of the 30 patients did not have regular ophthalmology visits, which suggests a study population with ocular symptoms or concerns about their eyesight, the researchers wrote. “The fact that 13% of our original cohort were reported to have severe visual impairment or worse in both eyes at any of the three follow-ups is noteworthy,” compared to reports of visual impairment of less than 0.5% in a German study in the general population for similar ages.
The findings were limited by several factors, including the retrospective design, small study population, and lack of data on 25 of the original 55-member study cohort, which may reduce the reliability of the current study, the researchers noted. However, the results reflect data from previous studies and support the need for JIA patients to continue regular ophthalmic checkups throughout life, they concluded.
The study was supported by Stiftelsen för Synskadade i f.d. Malmöhus län, Sweden, Skånes Universitetssjukhus Stiftelser och Donationer, Ögonfonden, and the Swedish Society of Medicine. The researchers had no financial conflicts to disclose.
FROM PEDIATRIC RHEUMATOLOGY
Medical management of miscarriage curbs costs and maintains quality of care
Medical management of early pregnancy loss costs less and offers similar quality of life to uterine aspiration, based on data from an analytical model.
Early pregnancy loss (EPL) occurs in more than 1 million women in the United States each year, and many patients are diagnosed before they show symptoms, wrote Divyah Nagendra, MD, of Cambridge Health Alliance, Mass., and colleagues.
A 2018 study showed that medical management of EPL with mifepristone added to misoprostol increased effectiveness and reduced the need for additional medication or subsequent uterine procedures, but the cost of mifepristone is perceived as a barrier, and the cost-effectiveness of its use, compared with surgical or expectant management, has not been well studied, the researchers noted.
“We already know that adding mifepristone to the medical management of early pregnancy loss increases the effectiveness of the regimen,” coauthor Courtney A. Schreiber, MD, of the University of Pennsylvania, Philadelphia, said in an interview. “Procedural uterine aspiration is highly effective as well, so patients and providers may consider the cost when deciding on a treatment strategy,” she added.
“If medication management is preferred by many patients, decreases the need to access in-person clinical care during a pandemic, and is found to be cost-effective, clinicians and policymakers should increase efforts to improve mifepristone availability and reduce access burdens,” the researchers wrote.
In a study published in the American Journal of Obstetrics & Gynecology, the researchers created a decision-analytic model using data from published literature and the Pregnancy Failure Regiments Trial (PreFaiR) to compare office-based uterine aspiration to medical management with mifepristone pretreatment followed by misoprostol for EPL.
The PrFaiR study randomized 300 women who experienced EPL before 12 weeks’ gestation to medication management with 800 mcg misoprostol vaginally, with or without pretreatment of 200 mg mifeprestone orally. The average age of the participants was 30.7 years, and demographics were similar between the groups.
The researchers used the PrFaiR data for medical management and patient-level data from published literature for uterine aspiration.
The primary outcome was the cost per quality-adjusted life year (QALY) gained. QALY was based on a modified utility score from the published literature. Effectiveness was based on QALY gained and the rate of complete expulsion of the gestational sac without additional intervention.
Overall, the mean costs per person were significantly higher for uterine aspiration, compared with medical management ($828 vs. $661, P = .004). Uterine aspiration was significantly more effective for complete gestational sac expulsion (97.3% vs. 83.8%, P = .0001). However, the QALYs were significantly higher for medical management, compared with uterine aspiration (0.082 vs. 0.079, P < .0001).
Cost-effectiveness was greater for medical management from a health care sector perspective, with lower costs and higher QALYs than uterine aspiration, the researchers noted.
They also evaluated the effect of mifepristone pretreatment on cost-effectiveness and found that medical management would remain cost effective, compared with uterine aspiration even if uterine aspiration procedures decreased in cost and mifepristone increased in cost, and even if medication management had a decreased completion rate and utility score, compared with uterine aspiration.
“Our analysis demonstrates that the incremental cost-effectiveness ratio (ICER) for medical management is well below the maximum willingness-to-pay threshold of approximately $100,000 per QALY gained,” the researchers wrote in their discussion of the findings.
Potential savings, uncertain access
Despite the potential savings and patient benefits, access to mifepristone remains a barrier, the researchers said.
Although the FDA lifted some restrictions on mifepristone in 2021 in the wake of the ongoing COVID-19 pandemic, the effect of new abortion-related restrictions remains to be seen.
The study findings were limited by several factors, including the use of 2018 National Medicare reimbursement rates to calculate costs, though actual costs vary by region and payer, the researchers noted. Other limitations include variations in cost of mifepristone by region and time and the differences in data sources between the uterine aspiration and medical management groups. More research is needed to assess QALYs for early pregnancy loss to establish standard measures and to assess the societal perspective of ESL as well as the health care perspective, they added.
However, the current results support medical management of EPL with mifepristone pretreatment followed by misoprostol as a “high-value care alternative” to office-based uterine aspiration, they said. “Increasing access to mifepristone and eliminating unnecessary restrictions will improve early pregnancy care,” they concluded.
“Given how effective procedural management is, we were slightly surprised that medical management remains cost effective,” Dr. Schreiber said in an interview.
Looking ahead in the wake of new restrictions on use for abortion, “patients may have difficulty accessing either medical or procedural management for early pregnancy loss,” Dr. Schreiber noted. “We support the accessibility of all evidence-based care and hope that our data will help overcome perceived financial barriers,” she said. Additional research needs include improved implementation and access to evidence-based early pregnancy loss care, she added.
Reasons to lift regulations
“Given the recent overturning of Roe v. Wade, any medications that are associated with abortion have increased scrutiny, especially mifepristone and misoprostol, even though these medications are also used for managing early pregnancy loss,” Sarah W. Prager, MD, of the University of Washington, Seattle, said in an interview. “Demonstrating that medication management of EPL with mifepristone/misoprostol is less expensive and has increased QALYs associated with it is yet another reason to deregulate mifepristone so it can also be more accessible for management of EPL,” said Dr. Prager, who was not involved in the study.
Dr. Prager said she was not surprised by the findings, as effective medication should be less expensive than a procedure. “I would caution that the increased QALYs found in this study should not be interpreted as a reason to restrict surgical management of EPL but to increase access also to medication management, even though medication has a slightly lower rate of complete gestational sac expulsion,” she noted. “Mode of management should be up to the patient, unless there is a clear medical reason for one or the other.”
Going forward, “the FDA has it in its power to remove the REMS, which would immediately make mifepristone a medication that can be prescribed through a pharmacy and therefore much more available,” said Dr. Prager. “Restrictions for both medication and surgical management of EPL will likely increase in states where abortion is illegal, and it could possibly lead to patients having less choice as to mode of management,” she explained.
“There are many studies showing that all modes of EPL management are safe and effective and should be supported with respect to patient choice,” Dr. Prager noted. “There are also substantial data supporting the overall safety of mifepristone, and there are no scientific or medical data suggesting the REMS increases safety in any way. Frankly, there are no good, evidence-based reasons to continue to keep the REMS in place,” she said.
The study was supported by the National Institute of Child Health and Human Development of the National Institutes of Health and a Society of Family Planning Research Fund Midcareer Mentor Award. The researchers had no financial conflicts to disclose. Dr. Prager had no financial conflicts to disclose and serves on the Editorial Advisory Board of Ob.Gyn. News.
Medical management of early pregnancy loss costs less and offers similar quality of life to uterine aspiration, based on data from an analytical model.
Early pregnancy loss (EPL) occurs in more than 1 million women in the United States each year, and many patients are diagnosed before they show symptoms, wrote Divyah Nagendra, MD, of Cambridge Health Alliance, Mass., and colleagues.
A 2018 study showed that medical management of EPL with mifepristone added to misoprostol increased effectiveness and reduced the need for additional medication or subsequent uterine procedures, but the cost of mifepristone is perceived as a barrier, and the cost-effectiveness of its use, compared with surgical or expectant management, has not been well studied, the researchers noted.
“We already know that adding mifepristone to the medical management of early pregnancy loss increases the effectiveness of the regimen,” coauthor Courtney A. Schreiber, MD, of the University of Pennsylvania, Philadelphia, said in an interview. “Procedural uterine aspiration is highly effective as well, so patients and providers may consider the cost when deciding on a treatment strategy,” she added.
“If medication management is preferred by many patients, decreases the need to access in-person clinical care during a pandemic, and is found to be cost-effective, clinicians and policymakers should increase efforts to improve mifepristone availability and reduce access burdens,” the researchers wrote.
In a study published in the American Journal of Obstetrics & Gynecology, the researchers created a decision-analytic model using data from published literature and the Pregnancy Failure Regiments Trial (PreFaiR) to compare office-based uterine aspiration to medical management with mifepristone pretreatment followed by misoprostol for EPL.
The PrFaiR study randomized 300 women who experienced EPL before 12 weeks’ gestation to medication management with 800 mcg misoprostol vaginally, with or without pretreatment of 200 mg mifeprestone orally. The average age of the participants was 30.7 years, and demographics were similar between the groups.
The researchers used the PrFaiR data for medical management and patient-level data from published literature for uterine aspiration.
The primary outcome was the cost per quality-adjusted life year (QALY) gained. QALY was based on a modified utility score from the published literature. Effectiveness was based on QALY gained and the rate of complete expulsion of the gestational sac without additional intervention.
Overall, the mean costs per person were significantly higher for uterine aspiration, compared with medical management ($828 vs. $661, P = .004). Uterine aspiration was significantly more effective for complete gestational sac expulsion (97.3% vs. 83.8%, P = .0001). However, the QALYs were significantly higher for medical management, compared with uterine aspiration (0.082 vs. 0.079, P < .0001).
Cost-effectiveness was greater for medical management from a health care sector perspective, with lower costs and higher QALYs than uterine aspiration, the researchers noted.
They also evaluated the effect of mifepristone pretreatment on cost-effectiveness and found that medical management would remain cost effective, compared with uterine aspiration even if uterine aspiration procedures decreased in cost and mifepristone increased in cost, and even if medication management had a decreased completion rate and utility score, compared with uterine aspiration.
“Our analysis demonstrates that the incremental cost-effectiveness ratio (ICER) for medical management is well below the maximum willingness-to-pay threshold of approximately $100,000 per QALY gained,” the researchers wrote in their discussion of the findings.
Potential savings, uncertain access
Despite the potential savings and patient benefits, access to mifepristone remains a barrier, the researchers said.
Although the FDA lifted some restrictions on mifepristone in 2021 in the wake of the ongoing COVID-19 pandemic, the effect of new abortion-related restrictions remains to be seen.
The study findings were limited by several factors, including the use of 2018 National Medicare reimbursement rates to calculate costs, though actual costs vary by region and payer, the researchers noted. Other limitations include variations in cost of mifepristone by region and time and the differences in data sources between the uterine aspiration and medical management groups. More research is needed to assess QALYs for early pregnancy loss to establish standard measures and to assess the societal perspective of ESL as well as the health care perspective, they added.
However, the current results support medical management of EPL with mifepristone pretreatment followed by misoprostol as a “high-value care alternative” to office-based uterine aspiration, they said. “Increasing access to mifepristone and eliminating unnecessary restrictions will improve early pregnancy care,” they concluded.
“Given how effective procedural management is, we were slightly surprised that medical management remains cost effective,” Dr. Schreiber said in an interview.
Looking ahead in the wake of new restrictions on use for abortion, “patients may have difficulty accessing either medical or procedural management for early pregnancy loss,” Dr. Schreiber noted. “We support the accessibility of all evidence-based care and hope that our data will help overcome perceived financial barriers,” she said. Additional research needs include improved implementation and access to evidence-based early pregnancy loss care, she added.
Reasons to lift regulations
“Given the recent overturning of Roe v. Wade, any medications that are associated with abortion have increased scrutiny, especially mifepristone and misoprostol, even though these medications are also used for managing early pregnancy loss,” Sarah W. Prager, MD, of the University of Washington, Seattle, said in an interview. “Demonstrating that medication management of EPL with mifepristone/misoprostol is less expensive and has increased QALYs associated with it is yet another reason to deregulate mifepristone so it can also be more accessible for management of EPL,” said Dr. Prager, who was not involved in the study.
Dr. Prager said she was not surprised by the findings, as effective medication should be less expensive than a procedure. “I would caution that the increased QALYs found in this study should not be interpreted as a reason to restrict surgical management of EPL but to increase access also to medication management, even though medication has a slightly lower rate of complete gestational sac expulsion,” she noted. “Mode of management should be up to the patient, unless there is a clear medical reason for one or the other.”
Going forward, “the FDA has it in its power to remove the REMS, which would immediately make mifepristone a medication that can be prescribed through a pharmacy and therefore much more available,” said Dr. Prager. “Restrictions for both medication and surgical management of EPL will likely increase in states where abortion is illegal, and it could possibly lead to patients having less choice as to mode of management,” she explained.
“There are many studies showing that all modes of EPL management are safe and effective and should be supported with respect to patient choice,” Dr. Prager noted. “There are also substantial data supporting the overall safety of mifepristone, and there are no scientific or medical data suggesting the REMS increases safety in any way. Frankly, there are no good, evidence-based reasons to continue to keep the REMS in place,” she said.
The study was supported by the National Institute of Child Health and Human Development of the National Institutes of Health and a Society of Family Planning Research Fund Midcareer Mentor Award. The researchers had no financial conflicts to disclose. Dr. Prager had no financial conflicts to disclose and serves on the Editorial Advisory Board of Ob.Gyn. News.
Medical management of early pregnancy loss costs less and offers similar quality of life to uterine aspiration, based on data from an analytical model.
Early pregnancy loss (EPL) occurs in more than 1 million women in the United States each year, and many patients are diagnosed before they show symptoms, wrote Divyah Nagendra, MD, of Cambridge Health Alliance, Mass., and colleagues.
A 2018 study showed that medical management of EPL with mifepristone added to misoprostol increased effectiveness and reduced the need for additional medication or subsequent uterine procedures, but the cost of mifepristone is perceived as a barrier, and the cost-effectiveness of its use, compared with surgical or expectant management, has not been well studied, the researchers noted.
“We already know that adding mifepristone to the medical management of early pregnancy loss increases the effectiveness of the regimen,” coauthor Courtney A. Schreiber, MD, of the University of Pennsylvania, Philadelphia, said in an interview. “Procedural uterine aspiration is highly effective as well, so patients and providers may consider the cost when deciding on a treatment strategy,” she added.
“If medication management is preferred by many patients, decreases the need to access in-person clinical care during a pandemic, and is found to be cost-effective, clinicians and policymakers should increase efforts to improve mifepristone availability and reduce access burdens,” the researchers wrote.
In a study published in the American Journal of Obstetrics & Gynecology, the researchers created a decision-analytic model using data from published literature and the Pregnancy Failure Regiments Trial (PreFaiR) to compare office-based uterine aspiration to medical management with mifepristone pretreatment followed by misoprostol for EPL.
The PrFaiR study randomized 300 women who experienced EPL before 12 weeks’ gestation to medication management with 800 mcg misoprostol vaginally, with or without pretreatment of 200 mg mifeprestone orally. The average age of the participants was 30.7 years, and demographics were similar between the groups.
The researchers used the PrFaiR data for medical management and patient-level data from published literature for uterine aspiration.
The primary outcome was the cost per quality-adjusted life year (QALY) gained. QALY was based on a modified utility score from the published literature. Effectiveness was based on QALY gained and the rate of complete expulsion of the gestational sac without additional intervention.
Overall, the mean costs per person were significantly higher for uterine aspiration, compared with medical management ($828 vs. $661, P = .004). Uterine aspiration was significantly more effective for complete gestational sac expulsion (97.3% vs. 83.8%, P = .0001). However, the QALYs were significantly higher for medical management, compared with uterine aspiration (0.082 vs. 0.079, P < .0001).
Cost-effectiveness was greater for medical management from a health care sector perspective, with lower costs and higher QALYs than uterine aspiration, the researchers noted.
They also evaluated the effect of mifepristone pretreatment on cost-effectiveness and found that medical management would remain cost effective, compared with uterine aspiration even if uterine aspiration procedures decreased in cost and mifepristone increased in cost, and even if medication management had a decreased completion rate and utility score, compared with uterine aspiration.
“Our analysis demonstrates that the incremental cost-effectiveness ratio (ICER) for medical management is well below the maximum willingness-to-pay threshold of approximately $100,000 per QALY gained,” the researchers wrote in their discussion of the findings.
Potential savings, uncertain access
Despite the potential savings and patient benefits, access to mifepristone remains a barrier, the researchers said.
Although the FDA lifted some restrictions on mifepristone in 2021 in the wake of the ongoing COVID-19 pandemic, the effect of new abortion-related restrictions remains to be seen.
The study findings were limited by several factors, including the use of 2018 National Medicare reimbursement rates to calculate costs, though actual costs vary by region and payer, the researchers noted. Other limitations include variations in cost of mifepristone by region and time and the differences in data sources between the uterine aspiration and medical management groups. More research is needed to assess QALYs for early pregnancy loss to establish standard measures and to assess the societal perspective of ESL as well as the health care perspective, they added.
However, the current results support medical management of EPL with mifepristone pretreatment followed by misoprostol as a “high-value care alternative” to office-based uterine aspiration, they said. “Increasing access to mifepristone and eliminating unnecessary restrictions will improve early pregnancy care,” they concluded.
“Given how effective procedural management is, we were slightly surprised that medical management remains cost effective,” Dr. Schreiber said in an interview.
Looking ahead in the wake of new restrictions on use for abortion, “patients may have difficulty accessing either medical or procedural management for early pregnancy loss,” Dr. Schreiber noted. “We support the accessibility of all evidence-based care and hope that our data will help overcome perceived financial barriers,” she said. Additional research needs include improved implementation and access to evidence-based early pregnancy loss care, she added.
Reasons to lift regulations
“Given the recent overturning of Roe v. Wade, any medications that are associated with abortion have increased scrutiny, especially mifepristone and misoprostol, even though these medications are also used for managing early pregnancy loss,” Sarah W. Prager, MD, of the University of Washington, Seattle, said in an interview. “Demonstrating that medication management of EPL with mifepristone/misoprostol is less expensive and has increased QALYs associated with it is yet another reason to deregulate mifepristone so it can also be more accessible for management of EPL,” said Dr. Prager, who was not involved in the study.
Dr. Prager said she was not surprised by the findings, as effective medication should be less expensive than a procedure. “I would caution that the increased QALYs found in this study should not be interpreted as a reason to restrict surgical management of EPL but to increase access also to medication management, even though medication has a slightly lower rate of complete gestational sac expulsion,” she noted. “Mode of management should be up to the patient, unless there is a clear medical reason for one or the other.”
Going forward, “the FDA has it in its power to remove the REMS, which would immediately make mifepristone a medication that can be prescribed through a pharmacy and therefore much more available,” said Dr. Prager. “Restrictions for both medication and surgical management of EPL will likely increase in states where abortion is illegal, and it could possibly lead to patients having less choice as to mode of management,” she explained.
“There are many studies showing that all modes of EPL management are safe and effective and should be supported with respect to patient choice,” Dr. Prager noted. “There are also substantial data supporting the overall safety of mifepristone, and there are no scientific or medical data suggesting the REMS increases safety in any way. Frankly, there are no good, evidence-based reasons to continue to keep the REMS in place,” she said.
The study was supported by the National Institute of Child Health and Human Development of the National Institutes of Health and a Society of Family Planning Research Fund Midcareer Mentor Award. The researchers had no financial conflicts to disclose. Dr. Prager had no financial conflicts to disclose and serves on the Editorial Advisory Board of Ob.Gyn. News.
FROM THE AMERICAN JOURNAL OF OBSTETRICS & GYNECOLOGY
Biologics reduce exacerbations in severe asthma
, based on data from more than 2,000 individuals.
The development of biologics to target specific inflammatory pathways “has transformed the management of uncontrolled SA,” but data on the real-world use of biologics in severe asthma patients treated by subspecialists are limited, wrote Reynold A. Panettieri, Jr., MD, of Rutgers, State University of New Jersey, New Brunswick, and colleagues.
In a study published in the Annals of Allergy, Asthma & Immunology, the researchers reviewed data from CHRONICLE, an ongoing, prospective, real-world noninterventional study of adults aged 18 years and older with severe asthma in the United States.
The study population included 2,847 patients enrolled in the CHRONICLE study between February 2018 and February 2021; 68.8% were women, 74.6% were White. The patients ranged in age from 18 to 89 years, with a mean age of 54.2 years.
Biologic use was defined as patients who started or had ongoing use of biologics between 12 months before enrollment and the patient’s most recent data collection. Switches were defined as stopping one biologic and starting another within 6 months; stops were defined as discontinuing a biologic without switching to another within 6 months. A total of 66% of the patients were using biologics at the time of study enrollment. The most common biologic was omalizumab (47%), followed by benralizumab (27%), mepolizumab (26%), and dupilumab (18%).
Overall, 89% of the patients had ongoing biologic use, 16% had biologic switches, and 13% had stops.
Patients who started biologics or switched biologics had significant reductions in asthma exacerbations at 6 months, compared with nonbiologic users of 58% (1.80 vs. 0.76 per patient-year) and 49% (1.47 vs. 0.75 per patient-year), respectively (P < .001 for both). Asthma exacerbations declined by 70% among biologics users for whom data were available for 12 months before and 12 months after starting biologics.
Exacerbations decreased at 6 months after biologic initiation across all subgroups of patients, notably patients with pre-biologic FEV1 < 80% and patients with FEV1 ≥ 80% (66% and 53%, respectively); never smokers and current/former smokers (63% and 50%, respectively); and patients with COPD and without COPD (58% and 52%, respectively).
The researchers also found a greater reduction in exacerbations among patients who switched from anti-IgE therapy to anti–IL-5/IL-5R/IL-4R therapy, compared with those who switched among anti–IL-5/IL-5R/IL-4R therapies (58% vs. 46%).
Patients who stopped or switched biologics appeared to have more severe or treatment-refractory disease than those with ongoing biologic use, the researchers noted. The most common reason for stopping or switching was worsening symptoms.
The study findings were limited by several factors, including the focus only on adults in the United States with subspecialist-treated SA, which may limit generalizability to children or other populations, the researchers noted. Other limitations included the variation in clinical decisions and insurance coverage and the inability to conduct longitudinal assessments, they said.
The results demonstrate that starting or switching biologics was consistently associated with fewer exacerbations in severe asthma. However, more research is needed to determine why some patients were not receiving biologics because they were not considered clinically eligible by their subspecialist health care providers, the researchers concluded.
The current study and the CHRONICLE study were supported by AstraZeneca. Lead author Dr. Panettieri disclosed serving on the advisory boards for and receiving grant support from AstraZeneca, Sanofi, Genentech, Regeneron, and Novartis.
, based on data from more than 2,000 individuals.
The development of biologics to target specific inflammatory pathways “has transformed the management of uncontrolled SA,” but data on the real-world use of biologics in severe asthma patients treated by subspecialists are limited, wrote Reynold A. Panettieri, Jr., MD, of Rutgers, State University of New Jersey, New Brunswick, and colleagues.
In a study published in the Annals of Allergy, Asthma & Immunology, the researchers reviewed data from CHRONICLE, an ongoing, prospective, real-world noninterventional study of adults aged 18 years and older with severe asthma in the United States.
The study population included 2,847 patients enrolled in the CHRONICLE study between February 2018 and February 2021; 68.8% were women, 74.6% were White. The patients ranged in age from 18 to 89 years, with a mean age of 54.2 years.
Biologic use was defined as patients who started or had ongoing use of biologics between 12 months before enrollment and the patient’s most recent data collection. Switches were defined as stopping one biologic and starting another within 6 months; stops were defined as discontinuing a biologic without switching to another within 6 months. A total of 66% of the patients were using biologics at the time of study enrollment. The most common biologic was omalizumab (47%), followed by benralizumab (27%), mepolizumab (26%), and dupilumab (18%).
Overall, 89% of the patients had ongoing biologic use, 16% had biologic switches, and 13% had stops.
Patients who started biologics or switched biologics had significant reductions in asthma exacerbations at 6 months, compared with nonbiologic users of 58% (1.80 vs. 0.76 per patient-year) and 49% (1.47 vs. 0.75 per patient-year), respectively (P < .001 for both). Asthma exacerbations declined by 70% among biologics users for whom data were available for 12 months before and 12 months after starting biologics.
Exacerbations decreased at 6 months after biologic initiation across all subgroups of patients, notably patients with pre-biologic FEV1 < 80% and patients with FEV1 ≥ 80% (66% and 53%, respectively); never smokers and current/former smokers (63% and 50%, respectively); and patients with COPD and without COPD (58% and 52%, respectively).
The researchers also found a greater reduction in exacerbations among patients who switched from anti-IgE therapy to anti–IL-5/IL-5R/IL-4R therapy, compared with those who switched among anti–IL-5/IL-5R/IL-4R therapies (58% vs. 46%).
Patients who stopped or switched biologics appeared to have more severe or treatment-refractory disease than those with ongoing biologic use, the researchers noted. The most common reason for stopping or switching was worsening symptoms.
The study findings were limited by several factors, including the focus only on adults in the United States with subspecialist-treated SA, which may limit generalizability to children or other populations, the researchers noted. Other limitations included the variation in clinical decisions and insurance coverage and the inability to conduct longitudinal assessments, they said.
The results demonstrate that starting or switching biologics was consistently associated with fewer exacerbations in severe asthma. However, more research is needed to determine why some patients were not receiving biologics because they were not considered clinically eligible by their subspecialist health care providers, the researchers concluded.
The current study and the CHRONICLE study were supported by AstraZeneca. Lead author Dr. Panettieri disclosed serving on the advisory boards for and receiving grant support from AstraZeneca, Sanofi, Genentech, Regeneron, and Novartis.
, based on data from more than 2,000 individuals.
The development of biologics to target specific inflammatory pathways “has transformed the management of uncontrolled SA,” but data on the real-world use of biologics in severe asthma patients treated by subspecialists are limited, wrote Reynold A. Panettieri, Jr., MD, of Rutgers, State University of New Jersey, New Brunswick, and colleagues.
In a study published in the Annals of Allergy, Asthma & Immunology, the researchers reviewed data from CHRONICLE, an ongoing, prospective, real-world noninterventional study of adults aged 18 years and older with severe asthma in the United States.
The study population included 2,847 patients enrolled in the CHRONICLE study between February 2018 and February 2021; 68.8% were women, 74.6% were White. The patients ranged in age from 18 to 89 years, with a mean age of 54.2 years.
Biologic use was defined as patients who started or had ongoing use of biologics between 12 months before enrollment and the patient’s most recent data collection. Switches were defined as stopping one biologic and starting another within 6 months; stops were defined as discontinuing a biologic without switching to another within 6 months. A total of 66% of the patients were using biologics at the time of study enrollment. The most common biologic was omalizumab (47%), followed by benralizumab (27%), mepolizumab (26%), and dupilumab (18%).
Overall, 89% of the patients had ongoing biologic use, 16% had biologic switches, and 13% had stops.
Patients who started biologics or switched biologics had significant reductions in asthma exacerbations at 6 months, compared with nonbiologic users of 58% (1.80 vs. 0.76 per patient-year) and 49% (1.47 vs. 0.75 per patient-year), respectively (P < .001 for both). Asthma exacerbations declined by 70% among biologics users for whom data were available for 12 months before and 12 months after starting biologics.
Exacerbations decreased at 6 months after biologic initiation across all subgroups of patients, notably patients with pre-biologic FEV1 < 80% and patients with FEV1 ≥ 80% (66% and 53%, respectively); never smokers and current/former smokers (63% and 50%, respectively); and patients with COPD and without COPD (58% and 52%, respectively).
The researchers also found a greater reduction in exacerbations among patients who switched from anti-IgE therapy to anti–IL-5/IL-5R/IL-4R therapy, compared with those who switched among anti–IL-5/IL-5R/IL-4R therapies (58% vs. 46%).
Patients who stopped or switched biologics appeared to have more severe or treatment-refractory disease than those with ongoing biologic use, the researchers noted. The most common reason for stopping or switching was worsening symptoms.
The study findings were limited by several factors, including the focus only on adults in the United States with subspecialist-treated SA, which may limit generalizability to children or other populations, the researchers noted. Other limitations included the variation in clinical decisions and insurance coverage and the inability to conduct longitudinal assessments, they said.
The results demonstrate that starting or switching biologics was consistently associated with fewer exacerbations in severe asthma. However, more research is needed to determine why some patients were not receiving biologics because they were not considered clinically eligible by their subspecialist health care providers, the researchers concluded.
The current study and the CHRONICLE study were supported by AstraZeneca. Lead author Dr. Panettieri disclosed serving on the advisory boards for and receiving grant support from AstraZeneca, Sanofi, Genentech, Regeneron, and Novartis.
FROM THE ANNALS OF ALLERGY, ASTHMA & IMMUNOLOGY
COPD predicts hospital readmission after fractures
Chronic obstructive pulmonary disease (COPD) was among the significant predictors of hospital readmission in older adults with fractures, based on data from nearly 400 individuals.
Fractures in the elderly remain a major health concern, and readmissions are common; however, Lara Cristina da Cunha Guimarães, MSN, of State School of Public Health Candido Santiago, State Department of Health of Goiás (Brazil), and colleagues wrote.
Previous research suggests that readmissions risk may be greater in patients with preadmission conditions including pulmonary and cardiac disease, history of stroke and other neurological conditions, and other factors associated with aging in general, they said.
In a study published in the journal Injury , the researchers reviewed data from 376 adults aged 60 years and older in a trauma referral hospital in Brazil who had suffered fractures and were hospitalized between Sept. 1, 2016, and Feb. 28, 2017. The primary outcome was readmission up to one year after discharge from the initial hospitalization for fracture.
Approximately half of the patients experienced femur fractures (53.2%), and the most frequent cause was falling from standing height (72.9%). The overall incidence of readmission was 20.7%. A total of 30.5% of readmissions were related to the fracture, and surgical-site infections were the most common cause of fracture-related complications.
More than half (58.3%) of the readmissions were related to clinical complications.
In a multivariate analysis, several clinical factors not related to fractures were independently associated with readmission, including a previous diagnosis of COPD, age between 60 and 69 years, a fracture of the femur, and delirium at the time of the first hospitalization for fracture.
Pneumonia was the most frequent cause of clinical complications, reflecting data from other recent studies, the researchers noted. “Elderly people with COPD are more susceptible to infections, such as pneumonia, which was a cause of frequent readmissions in the population studied. The presence of COPD can contribute to imbalance in the pulmonary microbiome, mucus production and persistent inflammation of the airways, and structural damage, which increases exposure of the pulmonary mucosa to pathogens.” COPD also can be associated with cardiovascular, mental, and musculoskeletal diseases that can further complicate and delay recovery from fractures.
The study findings were limited by the potential for incomplete information in medical records. However, the results indicate a range of causes and conditions associated with hospital readmission after fractures in older adults, they said. Recognizing these factors can guide plans for transitions from hospital to home care to reduce complications and readmissions.
The study received no outside funding. The researchers had no financial conflicts to disclose.
Chronic obstructive pulmonary disease (COPD) was among the significant predictors of hospital readmission in older adults with fractures, based on data from nearly 400 individuals.
Fractures in the elderly remain a major health concern, and readmissions are common; however, Lara Cristina da Cunha Guimarães, MSN, of State School of Public Health Candido Santiago, State Department of Health of Goiás (Brazil), and colleagues wrote.
Previous research suggests that readmissions risk may be greater in patients with preadmission conditions including pulmonary and cardiac disease, history of stroke and other neurological conditions, and other factors associated with aging in general, they said.
In a study published in the journal Injury , the researchers reviewed data from 376 adults aged 60 years and older in a trauma referral hospital in Brazil who had suffered fractures and were hospitalized between Sept. 1, 2016, and Feb. 28, 2017. The primary outcome was readmission up to one year after discharge from the initial hospitalization for fracture.
Approximately half of the patients experienced femur fractures (53.2%), and the most frequent cause was falling from standing height (72.9%). The overall incidence of readmission was 20.7%. A total of 30.5% of readmissions were related to the fracture, and surgical-site infections were the most common cause of fracture-related complications.
More than half (58.3%) of the readmissions were related to clinical complications.
In a multivariate analysis, several clinical factors not related to fractures were independently associated with readmission, including a previous diagnosis of COPD, age between 60 and 69 years, a fracture of the femur, and delirium at the time of the first hospitalization for fracture.
Pneumonia was the most frequent cause of clinical complications, reflecting data from other recent studies, the researchers noted. “Elderly people with COPD are more susceptible to infections, such as pneumonia, which was a cause of frequent readmissions in the population studied. The presence of COPD can contribute to imbalance in the pulmonary microbiome, mucus production and persistent inflammation of the airways, and structural damage, which increases exposure of the pulmonary mucosa to pathogens.” COPD also can be associated with cardiovascular, mental, and musculoskeletal diseases that can further complicate and delay recovery from fractures.
The study findings were limited by the potential for incomplete information in medical records. However, the results indicate a range of causes and conditions associated with hospital readmission after fractures in older adults, they said. Recognizing these factors can guide plans for transitions from hospital to home care to reduce complications and readmissions.
The study received no outside funding. The researchers had no financial conflicts to disclose.
Chronic obstructive pulmonary disease (COPD) was among the significant predictors of hospital readmission in older adults with fractures, based on data from nearly 400 individuals.
Fractures in the elderly remain a major health concern, and readmissions are common; however, Lara Cristina da Cunha Guimarães, MSN, of State School of Public Health Candido Santiago, State Department of Health of Goiás (Brazil), and colleagues wrote.
Previous research suggests that readmissions risk may be greater in patients with preadmission conditions including pulmonary and cardiac disease, history of stroke and other neurological conditions, and other factors associated with aging in general, they said.
In a study published in the journal Injury , the researchers reviewed data from 376 adults aged 60 years and older in a trauma referral hospital in Brazil who had suffered fractures and were hospitalized between Sept. 1, 2016, and Feb. 28, 2017. The primary outcome was readmission up to one year after discharge from the initial hospitalization for fracture.
Approximately half of the patients experienced femur fractures (53.2%), and the most frequent cause was falling from standing height (72.9%). The overall incidence of readmission was 20.7%. A total of 30.5% of readmissions were related to the fracture, and surgical-site infections were the most common cause of fracture-related complications.
More than half (58.3%) of the readmissions were related to clinical complications.
In a multivariate analysis, several clinical factors not related to fractures were independently associated with readmission, including a previous diagnosis of COPD, age between 60 and 69 years, a fracture of the femur, and delirium at the time of the first hospitalization for fracture.
Pneumonia was the most frequent cause of clinical complications, reflecting data from other recent studies, the researchers noted. “Elderly people with COPD are more susceptible to infections, such as pneumonia, which was a cause of frequent readmissions in the population studied. The presence of COPD can contribute to imbalance in the pulmonary microbiome, mucus production and persistent inflammation of the airways, and structural damage, which increases exposure of the pulmonary mucosa to pathogens.” COPD also can be associated with cardiovascular, mental, and musculoskeletal diseases that can further complicate and delay recovery from fractures.
The study findings were limited by the potential for incomplete information in medical records. However, the results indicate a range of causes and conditions associated with hospital readmission after fractures in older adults, they said. Recognizing these factors can guide plans for transitions from hospital to home care to reduce complications and readmissions.
The study received no outside funding. The researchers had no financial conflicts to disclose.
FROM INJURY
Water birth may have benefits for healthy women: Meta-analysis suggests
Water immersion during labor and birth significantly reduced use of medications, maternal pain, and postpartum hemorrhage, compared with standard care with no water immersion, based on data from 36 studies including more than 150,000 women.
“Resting and laboring in water can reduce fear, anxiety, and pain perception; it helps optimize the physiology of childbirth through the release of endogenous endorphins and oxytocin,” and data from randomized, controlled trials have shown a reduced need for epidural analgesia with water immersion, Ethel Burns, PhD, of Oxford (England) Brookes University Faculty of Health and Life Sciences, and colleagues wrote.
Although previous studies have not shown an increased risk for adverse events for newborns following water birth, “There is a need to understand which clinical practices, when performed as part of water immersion care, result in the optimum outcomes for mother and newborn,” the researchers said.
In a systematic review and meta-analysis published in BMJ Open, the researchers identified studies published since 2000 that examined maternal or neonatal interventions and/or outcomes when birthing pools were used for labor and/or birth.
The primary objective was to compare intrapartum interventions and outcomes for water immersion during labor with standard care with no water immersion.
Water immersion generally involves the use of a birth pool for relaxation and pain relief in early labor, and some women proceed with immersion through the second stage of labor and delivery. Of the 36 included studies, 31 took place in a hospital setting, 4 in a midwife-led setting, and 1 in a mixed setting. Most of the studies (25) involved women who planned to have/had a water birth, and these studies included 151,742 women. Another seven studies including 1,901 women involved in water immersion for labor only, three studies including 3,688 women involved in water immersion during labor and water birth; the timing of water immersion was unclear in the remaining study of 215 women.
Overall, water immersion significantly reduced the use of epidurals (odds ratio, 0.17), injected opioids (OR, 0.22), and episiotomy (OR, 0.16). Maternal pain and postpartum hemorrhage also were significantly reduced with water immersion (OR, 0.24 and OR, 0.69, respectively).
Maternal satisfaction was significantly increased with water immersion, and the odds of an intact perineum increased as well (OR, 1.95 and OR, 1.48).
The overall odds of cord avulsion increased with water immersion (OR, 1.94), but the absolute risk was low, compared with births without water immersion (4.3 vs. 1.3 per 1,000). No significant differences in other identified neonatal outcomes were observed across the studies.
The study findings were limited by several factors including the inconsistency of reporting on birth setting, care practices, interventions, and outcomes, and the inclusion of only three outcomes for meta-regression analysis, the researchers noted. In addition, only four studies were conducted in midwifery-led settings.
“This is important because birth pool use is most prevalent in midwifery-led settings,” the researchers wrote.” Evidence-based practice of water immersion requires research that reflects the context of care provision.
“We suggest that studies incorporate the following fundamentals to advance the evidence: birth pool description, clearly described maternal and obstetric characteristics, the birth setting, the care model and use of standardized definitions.”
Despite the limitations and need for additional research, the data overall support the potential benefits from water immersion births for healthy women and newborns, the researchers concluded.
A Clinical Report issued by the American Academy of Pediatrics in January 2022 advised against water immersion during the second stage of labor and delivery. According to the report, the potential for neonatal infections from organisms such as Legionella and Pseudomonas species, is low, but does exist, and could result in serious complications.
Education is essential
Increasing numbers of women are seeking home births and water births, Marissa Platner, MD, a maternal-fetal medicine specialist at Emory University, Atlanta, said in an interview.
“Given the conflicting data and lack of data, it is important to be able to educate birthing mothers based on best available evidence,” said Dr. Platner, who was not involved in the study.
“I was not surprised by the findings, because the adverse outcomes that are of concern, such as neonatal sepsis, were not clearly addressed,” Dr. Platner said. Given that sepsis “is a rare outcome in the population of low-risk individuals, the study may not have been powered to assess for this. The findings of maternal pain and satisfaction being improved with water immersion are well known. ACOG [American College of Obstetricians and Gynecologists] has also stated that water immersion during the first stage of labor is safe and can help with pain control.”
On a practical level, “I think clinicians can use this guidance to discuss the potential benefits of water immersion in the first stages of labor, but would caution women regarding the unknown but possible risks of the water birth, given these findings are less clear,” Dr. Platner said.
“I think the findings regarding maternal outcomes are valid and consistent with the AAP/ACOG recommendations in terms of improving maternal pain control; however, more research is needed to determine the safety of the second stage of labor occurring in the water, given the potential for neonatal infection and respiratory distress, which could not be adequately addressed in this study,” Dr. Platner emphasized.
The study was supported by Oxford Brookes University. The researchers had no financial conflicts to disclose. Dr. Platner had no financial conflicts to disclose.
Water immersion during labor and birth significantly reduced use of medications, maternal pain, and postpartum hemorrhage, compared with standard care with no water immersion, based on data from 36 studies including more than 150,000 women.
“Resting and laboring in water can reduce fear, anxiety, and pain perception; it helps optimize the physiology of childbirth through the release of endogenous endorphins and oxytocin,” and data from randomized, controlled trials have shown a reduced need for epidural analgesia with water immersion, Ethel Burns, PhD, of Oxford (England) Brookes University Faculty of Health and Life Sciences, and colleagues wrote.
Although previous studies have not shown an increased risk for adverse events for newborns following water birth, “There is a need to understand which clinical practices, when performed as part of water immersion care, result in the optimum outcomes for mother and newborn,” the researchers said.
In a systematic review and meta-analysis published in BMJ Open, the researchers identified studies published since 2000 that examined maternal or neonatal interventions and/or outcomes when birthing pools were used for labor and/or birth.
The primary objective was to compare intrapartum interventions and outcomes for water immersion during labor with standard care with no water immersion.
Water immersion generally involves the use of a birth pool for relaxation and pain relief in early labor, and some women proceed with immersion through the second stage of labor and delivery. Of the 36 included studies, 31 took place in a hospital setting, 4 in a midwife-led setting, and 1 in a mixed setting. Most of the studies (25) involved women who planned to have/had a water birth, and these studies included 151,742 women. Another seven studies including 1,901 women involved in water immersion for labor only, three studies including 3,688 women involved in water immersion during labor and water birth; the timing of water immersion was unclear in the remaining study of 215 women.
Overall, water immersion significantly reduced the use of epidurals (odds ratio, 0.17), injected opioids (OR, 0.22), and episiotomy (OR, 0.16). Maternal pain and postpartum hemorrhage also were significantly reduced with water immersion (OR, 0.24 and OR, 0.69, respectively).
Maternal satisfaction was significantly increased with water immersion, and the odds of an intact perineum increased as well (OR, 1.95 and OR, 1.48).
The overall odds of cord avulsion increased with water immersion (OR, 1.94), but the absolute risk was low, compared with births without water immersion (4.3 vs. 1.3 per 1,000). No significant differences in other identified neonatal outcomes were observed across the studies.
The study findings were limited by several factors including the inconsistency of reporting on birth setting, care practices, interventions, and outcomes, and the inclusion of only three outcomes for meta-regression analysis, the researchers noted. In addition, only four studies were conducted in midwifery-led settings.
“This is important because birth pool use is most prevalent in midwifery-led settings,” the researchers wrote.” Evidence-based practice of water immersion requires research that reflects the context of care provision.
“We suggest that studies incorporate the following fundamentals to advance the evidence: birth pool description, clearly described maternal and obstetric characteristics, the birth setting, the care model and use of standardized definitions.”
Despite the limitations and need for additional research, the data overall support the potential benefits from water immersion births for healthy women and newborns, the researchers concluded.
A Clinical Report issued by the American Academy of Pediatrics in January 2022 advised against water immersion during the second stage of labor and delivery. According to the report, the potential for neonatal infections from organisms such as Legionella and Pseudomonas species, is low, but does exist, and could result in serious complications.
Education is essential
Increasing numbers of women are seeking home births and water births, Marissa Platner, MD, a maternal-fetal medicine specialist at Emory University, Atlanta, said in an interview.
“Given the conflicting data and lack of data, it is important to be able to educate birthing mothers based on best available evidence,” said Dr. Platner, who was not involved in the study.
“I was not surprised by the findings, because the adverse outcomes that are of concern, such as neonatal sepsis, were not clearly addressed,” Dr. Platner said. Given that sepsis “is a rare outcome in the population of low-risk individuals, the study may not have been powered to assess for this. The findings of maternal pain and satisfaction being improved with water immersion are well known. ACOG [American College of Obstetricians and Gynecologists] has also stated that water immersion during the first stage of labor is safe and can help with pain control.”
On a practical level, “I think clinicians can use this guidance to discuss the potential benefits of water immersion in the first stages of labor, but would caution women regarding the unknown but possible risks of the water birth, given these findings are less clear,” Dr. Platner said.
“I think the findings regarding maternal outcomes are valid and consistent with the AAP/ACOG recommendations in terms of improving maternal pain control; however, more research is needed to determine the safety of the second stage of labor occurring in the water, given the potential for neonatal infection and respiratory distress, which could not be adequately addressed in this study,” Dr. Platner emphasized.
The study was supported by Oxford Brookes University. The researchers had no financial conflicts to disclose. Dr. Platner had no financial conflicts to disclose.
Water immersion during labor and birth significantly reduced use of medications, maternal pain, and postpartum hemorrhage, compared with standard care with no water immersion, based on data from 36 studies including more than 150,000 women.
“Resting and laboring in water can reduce fear, anxiety, and pain perception; it helps optimize the physiology of childbirth through the release of endogenous endorphins and oxytocin,” and data from randomized, controlled trials have shown a reduced need for epidural analgesia with water immersion, Ethel Burns, PhD, of Oxford (England) Brookes University Faculty of Health and Life Sciences, and colleagues wrote.
Although previous studies have not shown an increased risk for adverse events for newborns following water birth, “There is a need to understand which clinical practices, when performed as part of water immersion care, result in the optimum outcomes for mother and newborn,” the researchers said.
In a systematic review and meta-analysis published in BMJ Open, the researchers identified studies published since 2000 that examined maternal or neonatal interventions and/or outcomes when birthing pools were used for labor and/or birth.
The primary objective was to compare intrapartum interventions and outcomes for water immersion during labor with standard care with no water immersion.
Water immersion generally involves the use of a birth pool for relaxation and pain relief in early labor, and some women proceed with immersion through the second stage of labor and delivery. Of the 36 included studies, 31 took place in a hospital setting, 4 in a midwife-led setting, and 1 in a mixed setting. Most of the studies (25) involved women who planned to have/had a water birth, and these studies included 151,742 women. Another seven studies including 1,901 women involved in water immersion for labor only, three studies including 3,688 women involved in water immersion during labor and water birth; the timing of water immersion was unclear in the remaining study of 215 women.
Overall, water immersion significantly reduced the use of epidurals (odds ratio, 0.17), injected opioids (OR, 0.22), and episiotomy (OR, 0.16). Maternal pain and postpartum hemorrhage also were significantly reduced with water immersion (OR, 0.24 and OR, 0.69, respectively).
Maternal satisfaction was significantly increased with water immersion, and the odds of an intact perineum increased as well (OR, 1.95 and OR, 1.48).
The overall odds of cord avulsion increased with water immersion (OR, 1.94), but the absolute risk was low, compared with births without water immersion (4.3 vs. 1.3 per 1,000). No significant differences in other identified neonatal outcomes were observed across the studies.
The study findings were limited by several factors including the inconsistency of reporting on birth setting, care practices, interventions, and outcomes, and the inclusion of only three outcomes for meta-regression analysis, the researchers noted. In addition, only four studies were conducted in midwifery-led settings.
“This is important because birth pool use is most prevalent in midwifery-led settings,” the researchers wrote.” Evidence-based practice of water immersion requires research that reflects the context of care provision.
“We suggest that studies incorporate the following fundamentals to advance the evidence: birth pool description, clearly described maternal and obstetric characteristics, the birth setting, the care model and use of standardized definitions.”
Despite the limitations and need for additional research, the data overall support the potential benefits from water immersion births for healthy women and newborns, the researchers concluded.
A Clinical Report issued by the American Academy of Pediatrics in January 2022 advised against water immersion during the second stage of labor and delivery. According to the report, the potential for neonatal infections from organisms such as Legionella and Pseudomonas species, is low, but does exist, and could result in serious complications.
Education is essential
Increasing numbers of women are seeking home births and water births, Marissa Platner, MD, a maternal-fetal medicine specialist at Emory University, Atlanta, said in an interview.
“Given the conflicting data and lack of data, it is important to be able to educate birthing mothers based on best available evidence,” said Dr. Platner, who was not involved in the study.
“I was not surprised by the findings, because the adverse outcomes that are of concern, such as neonatal sepsis, were not clearly addressed,” Dr. Platner said. Given that sepsis “is a rare outcome in the population of low-risk individuals, the study may not have been powered to assess for this. The findings of maternal pain and satisfaction being improved with water immersion are well known. ACOG [American College of Obstetricians and Gynecologists] has also stated that water immersion during the first stage of labor is safe and can help with pain control.”
On a practical level, “I think clinicians can use this guidance to discuss the potential benefits of water immersion in the first stages of labor, but would caution women regarding the unknown but possible risks of the water birth, given these findings are less clear,” Dr. Platner said.
“I think the findings regarding maternal outcomes are valid and consistent with the AAP/ACOG recommendations in terms of improving maternal pain control; however, more research is needed to determine the safety of the second stage of labor occurring in the water, given the potential for neonatal infection and respiratory distress, which could not be adequately addressed in this study,” Dr. Platner emphasized.
The study was supported by Oxford Brookes University. The researchers had no financial conflicts to disclose. Dr. Platner had no financial conflicts to disclose.
FROM BMJ OPEN
Compulsivity contributes to poor outcomes in body-focused repetitive behaviors
Although body-focused repetitive behaviors (BFRBs), specifically trichotillomania and skin-picking disorder, are similar in clinical presentation to aspects of obsessive-compulsive disorder (OCD), the role of compulsivity in TTM and SPD has not been well studied, wrote Jon E. Grant, MD, of the University of Chicago and colleagues.
In a study published in the Journal of Psychiatric Research, the authors recruited 69 women and 22 men who met DSM-5 criteria for TTM and SPD. Participants completed diagnostic interviews, symptom inventories, and measures of disability/functioning. Compulsivity was measured using the 15-item Cambridge-Chicago Compulsivity Trait Scale (CHI-T). The average age of the participants was 30.9 years; 48 had TTM, 37 had SPD, and 2 had both conditions.
Overall, total CHI-T scores were significantly correlated with worse disability and quality of life, based on the Quality of Life Inventory (P = .0278) and the Sheehan Disability Scale (P = .0085) but not with severity of TTM or SPD symptoms. TTM and SPD symptoms were assessed using the Massachusetts General Hospital Hair Pulling Scale and the Skin Picking Symptom Symptom Assessment Scale.
“In the current study, we did not find a link between conventional symptom severity measures for BFRBs and disability or quality of life, whereas trans-diagnostic compulsivity did correlate with these clinically important parameters,” the researchers wrote in their discussion. “These findings might suggest the current symptom measures for BFRBs are not including an important aspect of the disease and that a fuller understanding of these symptoms requires measurement of compulsivity. Including validated measures of compulsivity in clinical trials of therapy or medication would also seem to be important for future work,” they said.
The study findings were limited by several factors including the use of a community sample that may not generalize to a clinical setting, the researchers noted. Other limitations include the cross-sectional design, which prevents conclusions about causality, the lack of a control group, and the relatively small sample size, they said.
However, the study is the first known to use a validated compulsivity measure to assess BFRBs, and the results suggest a clinically relevant impact of compulsivity on both psychosocial dysfunction and poor quality of life in this patient population, with possible implications for treatment, the researchers wrote.
The study received no outside funding. Lead author Dr. Grant disclosed research grants from Otsuka and Biohaven Pharmaceuticals, yearly compensation from Springer Publishing for acting as editor in chief of the Journal of Gambling Studies, and royalties from Oxford University Press, American Psychiatric Publishing, Norton Press, and McGraw Hill.
Although body-focused repetitive behaviors (BFRBs), specifically trichotillomania and skin-picking disorder, are similar in clinical presentation to aspects of obsessive-compulsive disorder (OCD), the role of compulsivity in TTM and SPD has not been well studied, wrote Jon E. Grant, MD, of the University of Chicago and colleagues.
In a study published in the Journal of Psychiatric Research, the authors recruited 69 women and 22 men who met DSM-5 criteria for TTM and SPD. Participants completed diagnostic interviews, symptom inventories, and measures of disability/functioning. Compulsivity was measured using the 15-item Cambridge-Chicago Compulsivity Trait Scale (CHI-T). The average age of the participants was 30.9 years; 48 had TTM, 37 had SPD, and 2 had both conditions.
Overall, total CHI-T scores were significantly correlated with worse disability and quality of life, based on the Quality of Life Inventory (P = .0278) and the Sheehan Disability Scale (P = .0085) but not with severity of TTM or SPD symptoms. TTM and SPD symptoms were assessed using the Massachusetts General Hospital Hair Pulling Scale and the Skin Picking Symptom Symptom Assessment Scale.
“In the current study, we did not find a link between conventional symptom severity measures for BFRBs and disability or quality of life, whereas trans-diagnostic compulsivity did correlate with these clinically important parameters,” the researchers wrote in their discussion. “These findings might suggest the current symptom measures for BFRBs are not including an important aspect of the disease and that a fuller understanding of these symptoms requires measurement of compulsivity. Including validated measures of compulsivity in clinical trials of therapy or medication would also seem to be important for future work,” they said.
The study findings were limited by several factors including the use of a community sample that may not generalize to a clinical setting, the researchers noted. Other limitations include the cross-sectional design, which prevents conclusions about causality, the lack of a control group, and the relatively small sample size, they said.
However, the study is the first known to use a validated compulsivity measure to assess BFRBs, and the results suggest a clinically relevant impact of compulsivity on both psychosocial dysfunction and poor quality of life in this patient population, with possible implications for treatment, the researchers wrote.
The study received no outside funding. Lead author Dr. Grant disclosed research grants from Otsuka and Biohaven Pharmaceuticals, yearly compensation from Springer Publishing for acting as editor in chief of the Journal of Gambling Studies, and royalties from Oxford University Press, American Psychiatric Publishing, Norton Press, and McGraw Hill.
Although body-focused repetitive behaviors (BFRBs), specifically trichotillomania and skin-picking disorder, are similar in clinical presentation to aspects of obsessive-compulsive disorder (OCD), the role of compulsivity in TTM and SPD has not been well studied, wrote Jon E. Grant, MD, of the University of Chicago and colleagues.
In a study published in the Journal of Psychiatric Research, the authors recruited 69 women and 22 men who met DSM-5 criteria for TTM and SPD. Participants completed diagnostic interviews, symptom inventories, and measures of disability/functioning. Compulsivity was measured using the 15-item Cambridge-Chicago Compulsivity Trait Scale (CHI-T). The average age of the participants was 30.9 years; 48 had TTM, 37 had SPD, and 2 had both conditions.
Overall, total CHI-T scores were significantly correlated with worse disability and quality of life, based on the Quality of Life Inventory (P = .0278) and the Sheehan Disability Scale (P = .0085) but not with severity of TTM or SPD symptoms. TTM and SPD symptoms were assessed using the Massachusetts General Hospital Hair Pulling Scale and the Skin Picking Symptom Symptom Assessment Scale.
“In the current study, we did not find a link between conventional symptom severity measures for BFRBs and disability or quality of life, whereas trans-diagnostic compulsivity did correlate with these clinically important parameters,” the researchers wrote in their discussion. “These findings might suggest the current symptom measures for BFRBs are not including an important aspect of the disease and that a fuller understanding of these symptoms requires measurement of compulsivity. Including validated measures of compulsivity in clinical trials of therapy or medication would also seem to be important for future work,” they said.
The study findings were limited by several factors including the use of a community sample that may not generalize to a clinical setting, the researchers noted. Other limitations include the cross-sectional design, which prevents conclusions about causality, the lack of a control group, and the relatively small sample size, they said.
However, the study is the first known to use a validated compulsivity measure to assess BFRBs, and the results suggest a clinically relevant impact of compulsivity on both psychosocial dysfunction and poor quality of life in this patient population, with possible implications for treatment, the researchers wrote.
The study received no outside funding. Lead author Dr. Grant disclosed research grants from Otsuka and Biohaven Pharmaceuticals, yearly compensation from Springer Publishing for acting as editor in chief of the Journal of Gambling Studies, and royalties from Oxford University Press, American Psychiatric Publishing, Norton Press, and McGraw Hill.
FROM THE JOURNAL OF PSYCHIATRIC RESEARCH
Mepolizumab curbed corticosteroid use for severe asthma
Use of mepolizumab significantly reduced the need for maintenance oral corticosteroids in adults with severe asthma, based on data from more than 800 individuals.
Many patients with severe asthma require bursts of systemic corticosteroids (SCS) or maintenance oral corticosteroids (mOCS) for disease control, but these strategies are associated with side effects that can increase the disease burden, wrote Charles Pilette, MD, of Cliniques Universitaires Saint-Luc, Brussels, and colleagues.
Previous studies have shown that the humanized, monoclonal anti-interleukin (IL)–5 antibody mepolizumab, which is approved for the treatment of severe asthma, reduced use of SCS and has shown effectiveness in less homogeneous populations, but robust, real-world data on the occurrence and magnitude of these effects are lacking, the researchers said.
In a study known as REALITI-A, the researchers enrolled 822 adults with asthma diagnoses from 82 centers in Europe, Canada, and the United States who initiated mepolizumab at a subcutaneous dose of 100 mg. The study endpoints included daily use of oral corticosteroids at baseline and 1 year, percentage reduction in oral corticosteroid use from baseline, patients discontinuing oral corticosteroids; the primary outcome was the rate of clinically significant exacerbations (CSEs). CSEs were defined as the need for OCS for at least 3 days/parenteral administration, and/or an emergency department or hospital admission before and after treatment. The mean age of the participants was 54 years, 63% were women, and 60% were never-smokers. The mean asthma duration was 19.7 years.
A total of 319 patients (39%), used mOCS at baseline, and dose information was available for 298.
Real-world outcomes
At 1 year, the median mOCS dose in the study population was reduced by 75%, and 64% reduced their mOCS dose by at least 50% from baseline.
In addition, the proportion of patients who discontinued daily mOCS increased from 29% during week 25-28 to 43% during week 53-56.
Overall, 80% of patients remained on mepolizumab at 1 year. Lack of efficacy and patient decision were the top two reasons for discontinuation (6% and 4%, respectively).
The primary outcome of rate of CSE decreased by a clinically significant rate ratio of 0.29 (P < .001).
“The requirement for SCS bursts was also reduced, as observed by a decreased rate of CSEs,” the researchers wrote in their discussion. The results were consistent for patients receiving lower (less than 10 mg/day) or higher (10 mg/day or more) mOCS doses at baseline, they said. No unexpected safety signals were noted during the study period.
“Furthermore, , or those requiring hospitalization or an ER visit, improved symptom control, and lower work productivity and activity impairment,” they added.
The study findings were limited by several factors including the observational design, lack of mepolizumab comparator, and open-label data capture, the researchers noted. However, the results were consistent with similar studies, and support the use of mepolizumab as part of the standard of care for clinically effective disease control in severe asthma patients, they concluded.
The study was funded by GlaxoSmithKline. Lead author Dr. Pilette disclosed fees for advisory boards, speaker meetings, and 42 research grants from GSK, AstraZeneca, Chiesi, Novartis, Teva, and ALK-Abello.
Use of mepolizumab significantly reduced the need for maintenance oral corticosteroids in adults with severe asthma, based on data from more than 800 individuals.
Many patients with severe asthma require bursts of systemic corticosteroids (SCS) or maintenance oral corticosteroids (mOCS) for disease control, but these strategies are associated with side effects that can increase the disease burden, wrote Charles Pilette, MD, of Cliniques Universitaires Saint-Luc, Brussels, and colleagues.
Previous studies have shown that the humanized, monoclonal anti-interleukin (IL)–5 antibody mepolizumab, which is approved for the treatment of severe asthma, reduced use of SCS and has shown effectiveness in less homogeneous populations, but robust, real-world data on the occurrence and magnitude of these effects are lacking, the researchers said.
In a study known as REALITI-A, the researchers enrolled 822 adults with asthma diagnoses from 82 centers in Europe, Canada, and the United States who initiated mepolizumab at a subcutaneous dose of 100 mg. The study endpoints included daily use of oral corticosteroids at baseline and 1 year, percentage reduction in oral corticosteroid use from baseline, patients discontinuing oral corticosteroids; the primary outcome was the rate of clinically significant exacerbations (CSEs). CSEs were defined as the need for OCS for at least 3 days/parenteral administration, and/or an emergency department or hospital admission before and after treatment. The mean age of the participants was 54 years, 63% were women, and 60% were never-smokers. The mean asthma duration was 19.7 years.
A total of 319 patients (39%), used mOCS at baseline, and dose information was available for 298.
Real-world outcomes
At 1 year, the median mOCS dose in the study population was reduced by 75%, and 64% reduced their mOCS dose by at least 50% from baseline.
In addition, the proportion of patients who discontinued daily mOCS increased from 29% during week 25-28 to 43% during week 53-56.
Overall, 80% of patients remained on mepolizumab at 1 year. Lack of efficacy and patient decision were the top two reasons for discontinuation (6% and 4%, respectively).
The primary outcome of rate of CSE decreased by a clinically significant rate ratio of 0.29 (P < .001).
“The requirement for SCS bursts was also reduced, as observed by a decreased rate of CSEs,” the researchers wrote in their discussion. The results were consistent for patients receiving lower (less than 10 mg/day) or higher (10 mg/day or more) mOCS doses at baseline, they said. No unexpected safety signals were noted during the study period.
“Furthermore, , or those requiring hospitalization or an ER visit, improved symptom control, and lower work productivity and activity impairment,” they added.
The study findings were limited by several factors including the observational design, lack of mepolizumab comparator, and open-label data capture, the researchers noted. However, the results were consistent with similar studies, and support the use of mepolizumab as part of the standard of care for clinically effective disease control in severe asthma patients, they concluded.
The study was funded by GlaxoSmithKline. Lead author Dr. Pilette disclosed fees for advisory boards, speaker meetings, and 42 research grants from GSK, AstraZeneca, Chiesi, Novartis, Teva, and ALK-Abello.
Use of mepolizumab significantly reduced the need for maintenance oral corticosteroids in adults with severe asthma, based on data from more than 800 individuals.
Many patients with severe asthma require bursts of systemic corticosteroids (SCS) or maintenance oral corticosteroids (mOCS) for disease control, but these strategies are associated with side effects that can increase the disease burden, wrote Charles Pilette, MD, of Cliniques Universitaires Saint-Luc, Brussels, and colleagues.
Previous studies have shown that the humanized, monoclonal anti-interleukin (IL)–5 antibody mepolizumab, which is approved for the treatment of severe asthma, reduced use of SCS and has shown effectiveness in less homogeneous populations, but robust, real-world data on the occurrence and magnitude of these effects are lacking, the researchers said.
In a study known as REALITI-A, the researchers enrolled 822 adults with asthma diagnoses from 82 centers in Europe, Canada, and the United States who initiated mepolizumab at a subcutaneous dose of 100 mg. The study endpoints included daily use of oral corticosteroids at baseline and 1 year, percentage reduction in oral corticosteroid use from baseline, patients discontinuing oral corticosteroids; the primary outcome was the rate of clinically significant exacerbations (CSEs). CSEs were defined as the need for OCS for at least 3 days/parenteral administration, and/or an emergency department or hospital admission before and after treatment. The mean age of the participants was 54 years, 63% were women, and 60% were never-smokers. The mean asthma duration was 19.7 years.
A total of 319 patients (39%), used mOCS at baseline, and dose information was available for 298.
Real-world outcomes
At 1 year, the median mOCS dose in the study population was reduced by 75%, and 64% reduced their mOCS dose by at least 50% from baseline.
In addition, the proportion of patients who discontinued daily mOCS increased from 29% during week 25-28 to 43% during week 53-56.
Overall, 80% of patients remained on mepolizumab at 1 year. Lack of efficacy and patient decision were the top two reasons for discontinuation (6% and 4%, respectively).
The primary outcome of rate of CSE decreased by a clinically significant rate ratio of 0.29 (P < .001).
“The requirement for SCS bursts was also reduced, as observed by a decreased rate of CSEs,” the researchers wrote in their discussion. The results were consistent for patients receiving lower (less than 10 mg/day) or higher (10 mg/day or more) mOCS doses at baseline, they said. No unexpected safety signals were noted during the study period.
“Furthermore, , or those requiring hospitalization or an ER visit, improved symptom control, and lower work productivity and activity impairment,” they added.
The study findings were limited by several factors including the observational design, lack of mepolizumab comparator, and open-label data capture, the researchers noted. However, the results were consistent with similar studies, and support the use of mepolizumab as part of the standard of care for clinically effective disease control in severe asthma patients, they concluded.
The study was funded by GlaxoSmithKline. Lead author Dr. Pilette disclosed fees for advisory boards, speaker meetings, and 42 research grants from GSK, AstraZeneca, Chiesi, Novartis, Teva, and ALK-Abello.
FROM JOURNAL OF ALLERGY AND CLINICAL IMMUNOLOGY: IN PRACTICE