Pulmonary Physiology & Rehabilitation Section

Interpretive strategies for routine lung function tests

In December 2021, the European Respiratory Journal published the, ERS/ATS technical standard on interpretive strategies for routine lung function tests (Stanojevic S, et al. Eur Respir J. 2021 Dec 23;2101499). Briefly, a few of the updated recommendations are discussed here.

First, the task force recommends the use of Global Lung Initiative (GLI) reference values for spirometry, lung volumes, and diffusing capacity of carbon monoxide. GLI equations were derived from the largest sample of healthy individuals to date and provide an internal consistency across all ages.

Second, it is now recommended that z-scores are used as opposed to percent predicted in grading severity of impairment. Z-scores, which refer to the number of standard deviations a measurement is positioned from the predicted value, centered at zero, account better for age, sex, and height biases compared with percent predicted, and is simplified into mild (z-score -1.65 to -2.5), moderate (-2.51 to -4), and severe (< -4) categories.

Finally, there are new and possibly controversial recommendations in defining a bronchodilator response and interpretation of change over time. A bronchodilator response is now defined as a > 10% change from the predicted value in FEV₁ or FVC while the concept of a conditional change score in children and FEV₁Q in adults has been introduced to describe lung function change.

The recommendations reflect and reiterate a shift in reporting a range of values, rather than using absolute threshold values, with an emphasis on the classification of physiologic impairments. The uncertainty present as lung function approaches the lower limit of normal is acknowledged, emphasizing the importance of pretest probability in making a clinical diagnosis and/or clinical decision. We encourage all pulmonary clinicians to review this important paper for more detailed information on these changes.

Tom DeCato, MD, Vice-Chair

Gina Lee, MD, Member-at-Large

Pulmonary Physiology & Rehabilitation Section

Interpretive strategies for routine lung function tests

In December 2021, the European Respiratory Journal published the, ERS/ATS technical standard on interpretive strategies for routine lung function tests (Stanojevic S, et al. Eur Respir J. 2021 Dec 23;2101499). Briefly, a few of the updated recommendations are discussed here.

First, the task force recommends the use of Global Lung Initiative (GLI) reference values for spirometry, lung volumes, and diffusing capacity of carbon monoxide. GLI equations were derived from the largest sample of healthy individuals to date and provide an internal consistency across all ages.

Second, it is now recommended that z-scores are used as opposed to percent predicted in grading severity of impairment. Z-scores, which refer to the number of standard deviations a measurement is positioned from the predicted value, centered at zero, account better for age, sex, and height biases compared with percent predicted, and is simplified into mild (z-score -1.65 to -2.5), moderate (-2.51 to -4), and severe (< -4) categories.

Finally, there are new and possibly controversial recommendations in defining a bronchodilator response and interpretation of change over time. A bronchodilator response is now defined as a > 10% change from the predicted value in FEV₁ or FVC while the concept of a conditional change score in children and FEV₁Q in adults has been introduced to describe lung function change.

The recommendations reflect and reiterate a shift in reporting a range of values, rather than using absolute threshold values, with an emphasis on the classification of physiologic impairments. The uncertainty present as lung function approaches the lower limit of normal is acknowledged, emphasizing the importance of pretest probability in making a clinical diagnosis and/or clinical decision. We encourage all pulmonary clinicians to review this important paper for more detailed information on these changes.

Tom DeCato, MD, Vice-Chair

Gina Lee, MD, Member-at-Large

Pulmonary Physiology & Rehabilitation Section

Interpretive strategies for routine lung function tests

In December 2021, the European Respiratory Journal published the, ERS/ATS technical standard on interpretive strategies for routine lung function tests (Stanojevic S, et al. Eur Respir J. 2021 Dec 23;2101499). Briefly, a few of the updated recommendations are discussed here.

First, the task force recommends the use of Global Lung Initiative (GLI) reference values for spirometry, lung volumes, and diffusing capacity of carbon monoxide. GLI equations were derived from the largest sample of healthy individuals to date and provide an internal consistency across all ages.

Second, it is now recommended that z-scores are used as opposed to percent predicted in grading severity of impairment. Z-scores, which refer to the number of standard deviations a measurement is positioned from the predicted value, centered at zero, account better for age, sex, and height biases compared with percent predicted, and is simplified into mild (z-score -1.65 to -2.5), moderate (-2.51 to -4), and severe (< -4) categories.

Finally, there are new and possibly controversial recommendations in defining a bronchodilator response and interpretation of change over time. A bronchodilator response is now defined as a > 10% change from the predicted value in FEV₁ or FVC while the concept of a conditional change score in children and FEV₁Q in adults has been introduced to describe lung function change.

The recommendations reflect and reiterate a shift in reporting a range of values, rather than using absolute threshold values, with an emphasis on the classification of physiologic impairments. The uncertainty present as lung function approaches the lower limit of normal is acknowledged, emphasizing the importance of pretest probability in making a clinical diagnosis and/or clinical decision. We encourage all pulmonary clinicians to review this important paper for more detailed information on these changes.

Tom DeCato, MD, Vice-Chair

Gina Lee, MD, Member-at-Large

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.

Pediatric Chest Medicine Section

Hope is on the horizon—new RSV protection for all infants

There is a dire unmet need for RSV protection in healthy term infants as available preventive therapies are limited and currently reserved for former preterm infants and those with certain underlying medical conditions (Brady MT, et al. Pediatrics. 2014;134[2]:415). Globally, RSV is a significant cause of lower respiratory tract infection impacting all age groups, yet, in infants and young children, the first infection may cause severe bronchiolitis that can be fatal (Li Y, et al. Lancet. 2022;399:2047).

There are currently three approaches for protection at various stages of clinical development. The first is direct administration of antibodies to the infant. Two potent, longer-lasting, single-dose monoclonal antibody products, including nirsevimab which is a monoclonal antibody to the RSV fusion protein that has an extended half-life, for the general infant population are in phase 3 trials (Hammitt LL, et al. N Engl J Med. 2022;386:837; Griffin PM, et al. N Engl J Med. 2020;383:415).

The third type of protection is active vaccination. Increased understanding of the biology of RSV and related technological advances have resulted in the entry of multiple vaccines into clinical development for pediatrics and adults, some of which may receive regulatory approval in the near future (Munoz FM, et al. Vaccine. 2021;39[22]:3053).

The burden of RSV is tremendous, yet the future of RSV protection looks promising.

Anne C. Coates, MD, FCCP, Member-at-Large
Mary Cataletto, MD, FCCP, Member-at-Large

Pediatric Chest Medicine Section

Hope is on the horizon—new RSV protection for all infants

There is a dire unmet need for RSV protection in healthy term infants as available preventive therapies are limited and currently reserved for former preterm infants and those with certain underlying medical conditions (Brady MT, et al. Pediatrics. 2014;134[2]:415). Globally, RSV is a significant cause of lower respiratory tract infection impacting all age groups, yet, in infants and young children, the first infection may cause severe bronchiolitis that can be fatal (Li Y, et al. Lancet. 2022;399:2047).

There are currently three approaches for protection at various stages of clinical development. The first is direct administration of antibodies to the infant. Two potent, longer-lasting, single-dose monoclonal antibody products, including nirsevimab which is a monoclonal antibody to the RSV fusion protein that has an extended half-life, for the general infant population are in phase 3 trials (Hammitt LL, et al. N Engl J Med. 2022;386:837; Griffin PM, et al. N Engl J Med. 2020;383:415).

The third type of protection is active vaccination. Increased understanding of the biology of RSV and related technological advances have resulted in the entry of multiple vaccines into clinical development for pediatrics and adults, some of which may receive regulatory approval in the near future (Munoz FM, et al. Vaccine. 2021;39[22]:3053).

The burden of RSV is tremendous, yet the future of RSV protection looks promising.

Anne C. Coates, MD, FCCP, Member-at-Large
Mary Cataletto, MD, FCCP, Member-at-Large

Pediatric Chest Medicine Section

Hope is on the horizon—new RSV protection for all infants

There is a dire unmet need for RSV protection in healthy term infants as available preventive therapies are limited and currently reserved for former preterm infants and those with certain underlying medical conditions (Brady MT, et al. Pediatrics. 2014;134[2]:415). Globally, RSV is a significant cause of lower respiratory tract infection impacting all age groups, yet, in infants and young children, the first infection may cause severe bronchiolitis that can be fatal (Li Y, et al. Lancet. 2022;399:2047).

There are currently three approaches for protection at various stages of clinical development. The first is direct administration of antibodies to the infant. Two potent, longer-lasting, single-dose monoclonal antibody products, including nirsevimab which is a monoclonal antibody to the RSV fusion protein that has an extended half-life, for the general infant population are in phase 3 trials (Hammitt LL, et al. N Engl J Med. 2022;386:837; Griffin PM, et al. N Engl J Med. 2020;383:415).

The third type of protection is active vaccination. Increased understanding of the biology of RSV and related technological advances have resulted in the entry of multiple vaccines into clinical development for pediatrics and adults, some of which may receive regulatory approval in the near future (Munoz FM, et al. Vaccine. 2021;39[22]:3053).

The burden of RSV is tremendous, yet the future of RSV protection looks promising.

Anne C. Coates, MD, FCCP, Member-at-Large
Mary Cataletto, MD, FCCP, Member-at-Large

Sepsis and Shock Section

SEP-1 measure saves lives, let’s not debate!

On December 21, 2021, the National Quality Form (NQF) re-endorsed Measure 0500 Severe Sepsis and Septic Shock: Management Bundle, which CMS adopts as the SEP-1 core measure. The decision was initially met by a request for appeal. On April 29, 2022, the appeals board met to adjudicate the appeal and voted unanimously to uphold the Standards Approval Committee (CSAC) decision to endorse the measure once again (https://tinyurl.com/yc4tjxbz).

The appeals board voted 5-0 on whether procedural errors reasonably affected the outcome of the original endorsement and whether there was new information or evidence unavailable at the time of the CSAC endorsement decision that would reasonably affect the outcome of the original endorsement decision.

The implementation of NQF 0500 and SEP-1 continues to spark controversy in the medical community even though the results of this bundled approach support an opportunity to save lives. SEP-1 compliance is associated with a lower 30-day mortality, and rendering this care saves lives.

In the Townsend, et al cohort study (Chest. 2022 Feb;161[2]:392) examining patient level Medicare data from October 2015 – March 2017, there was an absolute risk reduction of 5.67% in a standard propensity matched comparison of SEP-1 compliant vs noncompliant care. With a more stringent match, the absolute risk reduction was 4.06%. That’s an outcome that our patients likely appreciate the most…lives saved.

As former CHEST President, Dr. Steven Simpson highlighted in his April 2022 commentary (CHEST Physician. 2022 April;17[4]:15), “Success is not dependent only on what we do but on when we do it.” Let’s not debate any further.

Namita Jayaprakash, MBBCh
Member-at-Large

Sepsis and Shock Section

SEP-1 measure saves lives, let’s not debate!

On December 21, 2021, the National Quality Form (NQF) re-endorsed Measure 0500 Severe Sepsis and Septic Shock: Management Bundle, which CMS adopts as the SEP-1 core measure. The decision was initially met by a request for appeal. On April 29, 2022, the appeals board met to adjudicate the appeal and voted unanimously to uphold the Standards Approval Committee (CSAC) decision to endorse the measure once again (https://tinyurl.com/yc4tjxbz).

The appeals board voted 5-0 on whether procedural errors reasonably affected the outcome of the original endorsement and whether there was new information or evidence unavailable at the time of the CSAC endorsement decision that would reasonably affect the outcome of the original endorsement decision.

The implementation of NQF 0500 and SEP-1 continues to spark controversy in the medical community even though the results of this bundled approach support an opportunity to save lives. SEP-1 compliance is associated with a lower 30-day mortality, and rendering this care saves lives.

In the Townsend, et al cohort study (Chest. 2022 Feb;161[2]:392) examining patient level Medicare data from October 2015 – March 2017, there was an absolute risk reduction of 5.67% in a standard propensity matched comparison of SEP-1 compliant vs noncompliant care. With a more stringent match, the absolute risk reduction was 4.06%. That’s an outcome that our patients likely appreciate the most…lives saved.

As former CHEST President, Dr. Steven Simpson highlighted in his April 2022 commentary (CHEST Physician. 2022 April;17[4]:15), “Success is not dependent only on what we do but on when we do it.” Let’s not debate any further.

Namita Jayaprakash, MBBCh
Member-at-Large

Sepsis and Shock Section

SEP-1 measure saves lives, let’s not debate!

On December 21, 2021, the National Quality Form (NQF) re-endorsed Measure 0500 Severe Sepsis and Septic Shock: Management Bundle, which CMS adopts as the SEP-1 core measure. The decision was initially met by a request for appeal. On April 29, 2022, the appeals board met to adjudicate the appeal and voted unanimously to uphold the Standards Approval Committee (CSAC) decision to endorse the measure once again (https://tinyurl.com/yc4tjxbz).

The appeals board voted 5-0 on whether procedural errors reasonably affected the outcome of the original endorsement and whether there was new information or evidence unavailable at the time of the CSAC endorsement decision that would reasonably affect the outcome of the original endorsement decision.

The implementation of NQF 0500 and SEP-1 continues to spark controversy in the medical community even though the results of this bundled approach support an opportunity to save lives. SEP-1 compliance is associated with a lower 30-day mortality, and rendering this care saves lives.

In the Townsend, et al cohort study (Chest. 2022 Feb;161[2]:392) examining patient level Medicare data from October 2015 – March 2017, there was an absolute risk reduction of 5.67% in a standard propensity matched comparison of SEP-1 compliant vs noncompliant care. With a more stringent match, the absolute risk reduction was 4.06%. That’s an outcome that our patients likely appreciate the most…lives saved.

As former CHEST President, Dr. Steven Simpson highlighted in his April 2022 commentary (CHEST Physician. 2022 April;17[4]:15), “Success is not dependent only on what we do but on when we do it.” Let’s not debate any further.

Namita Jayaprakash, MBBCh
Member-at-Large

Respiratory-Related Sleep Disorders Section

Reducing racial disparities in sleep apnea

Health inequity pervades many aspects of medicine, including the care of patients with obstructive sleep apnea. For example, a growing body of research has shown that black race is associated with underdiagnosis of OSA, greater disease severity at time of diagnosis and reduced PAP adherence (Hsu N, et al. J Clin Sleep Med. 2020;16[8]:1249; Thornton JD, et al. Ann Am Thorac Soc. 2022;19[2]:272).

A recent article (Billings ME, et al. Chest. 2021;159[3]:1232) offered potential strategies to mitigate racial disparities in sleep apnea management. To expand access to care, they advocate embracing telemedicine for those who may have difficulty coming to clinic – due to transportation issues, arranging sufficient time off work, or residing in remote locations. On the other hand, an over-reliance on telemedicine has the potential to worsen disparities in populations whose access to technology is limited.

The higher proportion of nonwhite providers in these groups as compared with sleep specialists may improve care, since concordant race provision has been associated with better communication. Underlying these interventions is the need to diversify representation within the medical field at large.

Swetha Gogineni, MD, Vice-Chair
Lauren Tobias, MD, Member-at-Large

Respiratory-Related Sleep Disorders Section

Reducing racial disparities in sleep apnea

Health inequity pervades many aspects of medicine, including the care of patients with obstructive sleep apnea. For example, a growing body of research has shown that black race is associated with underdiagnosis of OSA, greater disease severity at time of diagnosis and reduced PAP adherence (Hsu N, et al. J Clin Sleep Med. 2020;16[8]:1249; Thornton JD, et al. Ann Am Thorac Soc. 2022;19[2]:272).

A recent article (Billings ME, et al. Chest. 2021;159[3]:1232) offered potential strategies to mitigate racial disparities in sleep apnea management. To expand access to care, they advocate embracing telemedicine for those who may have difficulty coming to clinic – due to transportation issues, arranging sufficient time off work, or residing in remote locations. On the other hand, an over-reliance on telemedicine has the potential to worsen disparities in populations whose access to technology is limited.

The higher proportion of nonwhite providers in these groups as compared with sleep specialists may improve care, since concordant race provision has been associated with better communication. Underlying these interventions is the need to diversify representation within the medical field at large.

Swetha Gogineni, MD, Vice-Chair
Lauren Tobias, MD, Member-at-Large

Respiratory-Related Sleep Disorders Section

Reducing racial disparities in sleep apnea

Health inequity pervades many aspects of medicine, including the care of patients with obstructive sleep apnea. For example, a growing body of research has shown that black race is associated with underdiagnosis of OSA, greater disease severity at time of diagnosis and reduced PAP adherence (Hsu N, et al. J Clin Sleep Med. 2020;16[8]:1249; Thornton JD, et al. Ann Am Thorac Soc. 2022;19[2]:272).

A recent article (Billings ME, et al. Chest. 2021;159[3]:1232) offered potential strategies to mitigate racial disparities in sleep apnea management. To expand access to care, they advocate embracing telemedicine for those who may have difficulty coming to clinic – due to transportation issues, arranging sufficient time off work, or residing in remote locations. On the other hand, an over-reliance on telemedicine has the potential to worsen disparities in populations whose access to technology is limited.

The higher proportion of nonwhite providers in these groups as compared with sleep specialists may improve care, since concordant race provision has been associated with better communication. Underlying these interventions is the need to diversify representation within the medical field at large.

Swetha Gogineni, MD, Vice-Chair
Lauren Tobias, MD, Member-at-Large

Pulmonary Vascular Disease Section

Restoration of RV function in PAH: Is it the holy grail to improve mortality and long-term outcomes?

Pulmonary arterial hypertension (PAH) remains an incurable disease, and clinical progression is inevitable. Despite several therapeutic advances, PAH continues to be associated with high mortality. Even mild increases in mean pulmonary arterial pressure (mPAP) have been shown to directly impact outcomes (Maron BA, et al. Circulation. 2016 Mar 29;133[13]:1240), leading to a change in the hemodynamic definition of PAH (mPAP > 20 mm Hg) at the 2018 World Symposium on Pulmonary Hypertension (WSPH) (Galiè N, et al. Eur Respir J. 2019;53[1]:1801889). The WSPH also recommended a more aggressive and proactive approach to move patients to “low-risk” status.

Elevated mPAP results in increased RV afterload with subsequent RV dysfunction and consequent abnormal remodeling, which is associated with poor outcomes. Reversal of RV remodeling has been demonstrated in patients after PEA for CTEPH and/or lung transplantation for PAH (D’Armini AM, et al. J Thorac Cardiovasc Surg. 2007;133:162).

Vijay Balasubramanian, MD, FCCP, Chair
Jean M. Elwing, MD, FCCP, Ex-Officio

Pulmonary Vascular Disease Section

Restoration of RV function in PAH: Is it the holy grail to improve mortality and long-term outcomes?

Pulmonary arterial hypertension (PAH) remains an incurable disease, and clinical progression is inevitable. Despite several therapeutic advances, PAH continues to be associated with high mortality. Even mild increases in mean pulmonary arterial pressure (mPAP) have been shown to directly impact outcomes (Maron BA, et al. Circulation. 2016 Mar 29;133[13]:1240), leading to a change in the hemodynamic definition of PAH (mPAP > 20 mm Hg) at the 2018 World Symposium on Pulmonary Hypertension (WSPH) (Galiè N, et al. Eur Respir J. 2019;53[1]:1801889). The WSPH also recommended a more aggressive and proactive approach to move patients to “low-risk” status.

Elevated mPAP results in increased RV afterload with subsequent RV dysfunction and consequent abnormal remodeling, which is associated with poor outcomes. Reversal of RV remodeling has been demonstrated in patients after PEA for CTEPH and/or lung transplantation for PAH (D’Armini AM, et al. J Thorac Cardiovasc Surg. 2007;133:162).

Vijay Balasubramanian, MD, FCCP, Chair
Jean M. Elwing, MD, FCCP, Ex-Officio

Pulmonary Vascular Disease Section

Restoration of RV function in PAH: Is it the holy grail to improve mortality and long-term outcomes?

Pulmonary arterial hypertension (PAH) remains an incurable disease, and clinical progression is inevitable. Despite several therapeutic advances, PAH continues to be associated with high mortality. Even mild increases in mean pulmonary arterial pressure (mPAP) have been shown to directly impact outcomes (Maron BA, et al. Circulation. 2016 Mar 29;133[13]:1240), leading to a change in the hemodynamic definition of PAH (mPAP > 20 mm Hg) at the 2018 World Symposium on Pulmonary Hypertension (WSPH) (Galiè N, et al. Eur Respir J. 2019;53[1]:1801889). The WSPH also recommended a more aggressive and proactive approach to move patients to “low-risk” status.

Elevated mPAP results in increased RV afterload with subsequent RV dysfunction and consequent abnormal remodeling, which is associated with poor outcomes. Reversal of RV remodeling has been demonstrated in patients after PEA for CTEPH and/or lung transplantation for PAH (D’Armini AM, et al. J Thorac Cardiovasc Surg. 2007;133:162).

Vijay Balasubramanian, MD, FCCP, Chair
Jean M. Elwing, MD, FCCP, Ex-Officio

Interventional Procedures Section

Role of EBUS for staging and prognostication in patients with lung cancer

Lung cancer is the leading cause of cancer-related deaths worldwide and forms of a large burden of cancer-related mortality in the United States. With the rapid advent of new disease-directed therapy, including molecular and targeted therapies, the outlook for management of lung cancer has changed dramatically over the last decade. The choice of therapy, as well as prognosis, is dependent on the stage at diagnosis. It is thus imperative that we accurately differentiate between stages I, II, and III disease by assessment of hilar and mediastinal lymph nodes.

Traditionally, CT and PET/CT scans have been the mainstay to assess stage, with patients with abnormal lymph nodes or high risk of nodal metastasis (≥ T2 disease or “central” location) undergoing invasive mediastinal evaluation (Silvestri, et al. Chest. 2013 May;143(5 Suppl):e211S). The decision to perform invasive mediastinal staging for T1 tumors remains a matter of discussion. DuComb and colleagues, in their study demonstrated a high rate of N2 metastasis (8.1%) even amongst those with T1 tumors, which was independent of tumor location (DuComb, et al. Chest. 2020 Nov;158[5]:2192). This rate is consistent with previous reported rates ranging from 6.9% to 13% of N2 disease in patients with no radiographic evidence of lymph node metastasis (Gonzalez-Stawinski, et al. J Thorac Cardiovasc Surg. 2003 Dec;126[6]:1900; Bao, et al. J Thorac Dis. 2014;6[12]:1697; Shin, et al. Eur Respir J. 2019;53[3]:1801508). The above indicates a possible role of invasive mediastinal staging using EBUS-TBNA in patients with T1 disease to accurately stage the disease prior to curative intent treatment.

Abhinav Agrawal, MD, FCCP, Member-at-Large
Ellen Volker, MD, MSPH, FCCP, Member-at-Large

Interventional Procedures Section

Role of EBUS for staging and prognostication in patients with lung cancer

Lung cancer is the leading cause of cancer-related deaths worldwide and forms of a large burden of cancer-related mortality in the United States. With the rapid advent of new disease-directed therapy, including molecular and targeted therapies, the outlook for management of lung cancer has changed dramatically over the last decade. The choice of therapy, as well as prognosis, is dependent on the stage at diagnosis. It is thus imperative that we accurately differentiate between stages I, II, and III disease by assessment of hilar and mediastinal lymph nodes.

Traditionally, CT and PET/CT scans have been the mainstay to assess stage, with patients with abnormal lymph nodes or high risk of nodal metastasis (≥ T2 disease or “central” location) undergoing invasive mediastinal evaluation (Silvestri, et al. Chest. 2013 May;143(5 Suppl):e211S). The decision to perform invasive mediastinal staging for T1 tumors remains a matter of discussion. DuComb and colleagues, in their study demonstrated a high rate of N2 metastasis (8.1%) even amongst those with T1 tumors, which was independent of tumor location (DuComb, et al. Chest. 2020 Nov;158[5]:2192). This rate is consistent with previous reported rates ranging from 6.9% to 13% of N2 disease in patients with no radiographic evidence of lymph node metastasis (Gonzalez-Stawinski, et al. J Thorac Cardiovasc Surg. 2003 Dec;126[6]:1900; Bao, et al. J Thorac Dis. 2014;6[12]:1697; Shin, et al. Eur Respir J. 2019;53[3]:1801508). The above indicates a possible role of invasive mediastinal staging using EBUS-TBNA in patients with T1 disease to accurately stage the disease prior to curative intent treatment.

Abhinav Agrawal, MD, FCCP, Member-at-Large
Ellen Volker, MD, MSPH, FCCP, Member-at-Large

Interventional Procedures Section

Role of EBUS for staging and prognostication in patients with lung cancer

Lung cancer is the leading cause of cancer-related deaths worldwide and forms of a large burden of cancer-related mortality in the United States. With the rapid advent of new disease-directed therapy, including molecular and targeted therapies, the outlook for management of lung cancer has changed dramatically over the last decade. The choice of therapy, as well as prognosis, is dependent on the stage at diagnosis. It is thus imperative that we accurately differentiate between stages I, II, and III disease by assessment of hilar and mediastinal lymph nodes.

Traditionally, CT and PET/CT scans have been the mainstay to assess stage, with patients with abnormal lymph nodes or high risk of nodal metastasis (≥ T2 disease or “central” location) undergoing invasive mediastinal evaluation (Silvestri, et al. Chest. 2013 May;143(5 Suppl):e211S). The decision to perform invasive mediastinal staging for T1 tumors remains a matter of discussion. DuComb and colleagues, in their study demonstrated a high rate of N2 metastasis (8.1%) even amongst those with T1 tumors, which was independent of tumor location (DuComb, et al. Chest. 2020 Nov;158[5]:2192). This rate is consistent with previous reported rates ranging from 6.9% to 13% of N2 disease in patients with no radiographic evidence of lymph node metastasis (Gonzalez-Stawinski, et al. J Thorac Cardiovasc Surg. 2003 Dec;126[6]:1900; Bao, et al. J Thorac Dis. 2014;6[12]:1697; Shin, et al. Eur Respir J. 2019;53[3]:1801508). The above indicates a possible role of invasive mediastinal staging using EBUS-TBNA in patients with T1 disease to accurately stage the disease prior to curative intent treatment.

Abhinav Agrawal, MD, FCCP, Member-at-Large
Ellen Volker, MD, MSPH, FCCP, Member-at-Large

Patients with rheumatoid arthritis or inflammatory bowel disease (IBD) taking a tumor necrosis factor–alpha inhibitor (TNFi) have about a two-fold higher risk of developing psoriasis, compared with patients receiving conventional treatment, according to a new study published in JAMA Dermatology.

Despite this finding, the authors of the large Danish nationwide cohort study noted that TNFi-induced psoriasis is still a rare adverse event. “Practitioners and patients should be aware and observant of the potential for TNFi-associated psoriasis during TNFi treatment but keep in mind that the absolute risk appears to be low,” David Thein, MB, of the department of dermatology at Bispebjerg Hospital, University of Copenhagen, and colleagues wrote in the study.

They analyzed 109,085 patients with RA and IBD enrolled in Danish national registries between 1995 and 2018 without a previous diagnosis of psoriasis, who received either TNFi (20,910 patients) or conventional treatments (108,024 patients) and were followed for 5 years. They were a mean of 50 years old when they started treatment, 62% were women, with 87.8% of patients in the TNFi group receiving prior conventional therapy and 1% of patients in the conventional therapy group receiving prior TNFi treatment.

The investigators assessed the risk of developing any psoriasis, nonpustular psoriasis, and pustular psoriasis in the two groups using ICD-10 codes as well as a record of two consecutive prescriptions for topical vitamin D analogs.

Overall, 1,471 patients (1.4%) developed psoriasis of any type; 1,332 had non-pustular psoriasis, 127 had palmoplantar pustulosis, and 12 had generalized pustulosis.

The incidence rate of developing any psoriasis was 3.0 per 1,000 patient-years (95% confidence interval, 2.9-3.2) for patients receiving conventional therapy and 7.8 per 1,000 patient-years (95% CI, 7.5-8.9) for patients receiving TNFi treatment. Compared with conventional treatment, the risk of developing nonpustular psoriasis was twofold higher among patients receiving TNFi treatment (hazard ratio, 2.12; 95% CI, 1.87-2.40; P < .001). The risk of developing pustular psoriasis was more than sixfold higher among those on a TNFi (HR, 6.50; 95% CI, 4.60-9.23; P < .001).

Dr. Thein and colleagues estimated that the exposure needed to harm 1 additional patient was 241 patient-years for any psoriasis type, 342 patient-years for nonpustular psoriasis, and 909 patient-years for pustular psoriasis, with an estimated absolute risk difference of 5 per 1,000 patient-years.
 

Best evidence to date on risk

Asked to comment on the study findings, Anthony Fernandez, MD, PhD, director of medical dermatology at the Cleveland Clinic, said that he applauded the researchers for performing this well-designed study to determine the risk of TNF inhibitor–induced psoriasis in patients with RA and IBD.

The strengths of the study include excluding patients with a history of psoriasis to rule out disease recurrence and having a large comparator group of patients with IBD and RA who were taking medications other than TNF inhibitors, while one limitation was the potential accuracy of the ICD-10 codes used as the basis for diagnosing psoriasis. “It’s probably closer to the truth of what the true risk is compared to studies done in the past,” he said in an interview.

Dr. Fernandez noted that the results aren’t likely to change how dermatologists, rheumatologists, or gastroenterologists practice, but the message to stay the course in initially treating TNFi-induced psoriasis also holds value. “We don’t need to change anything in our clinical practice when it comes to TNF-alpha inhibitors.”

For patients with RA or IBD who develop TNFi-induced psoriasis with disease that is well controlled with TNFi treatment, keeping them on that treatment is a priority, Dr. Fernandez explained. “The first and foremost goal is, if the TNF inhibitor is working very well to control the disease that it was prescribed for, then you exhaust your efforts to try to control the psoriasis and allow those patients to stay on the TNF inhibitor.”

In his experience, most patients with RA and IBD who develop TNFi-induced psoriasis are controlled with topical medications. Switching to another TNFi is not recommended, he noted, as patients are “likely to have that reaction with any TNF inhibitor.”

However, Dr. Fernandez said that won’t be an option for all patients with RA and IBD. “In some patients you do simply have to stop the TNF inhibitor” and try an alternative treatment with a different mechanism of action.

The cause of TNFi-induced psoriasis is still not well understood. “There certainly is evidence to support that interferon alpha production by plasmacytoid dendritic cells is playing some role in this phenomenon,” but there is “more to the story” and unanswered questions remain, Dr. Fernandez said.

What’s most interesting about this phenomenon, he added, is that “patients can develop it at any time when exposed to a TNF inhibitor.” For instance, most patients develop drug reactions within 2­-3 weeks of starting a treatment, but TNFi-induced psoriasis can appear after a single dose or several years after initiating treatment.

“Why so few patients, and why is there such variability in terms of how long they’re on the TNF inhibitor before the reaction occurs?” he asked. “That really points to ... some other trigger besides exposure to the TNF inhibitor needed for the initiation of this reaction.”

He noted that it would be valuable to identify triggers – or the most likely triggers – which would be challenging, but could “potentially impact clinical practice.”

The authors reported personal and institutional relationships in the form of personal and institutional research grants, honoraria, personal fees, investigator fees paid to university, consultancies, and speaker’s bureau positions for a variety of pharmaceutical companies, data companies, hospitals, and foundations. Dr. Fernandez reported he has nonbranded speaking, consulting, and research relationships with AbbVie and Novartis; and is a consultant for UCB, Bristol-Myers Squibb, and Boehringer Ingelheim on related products.

Patients with rheumatoid arthritis or inflammatory bowel disease (IBD) taking a tumor necrosis factor–alpha inhibitor (TNFi) have about a two-fold higher risk of developing psoriasis, compared with patients receiving conventional treatment, according to a new study published in JAMA Dermatology.

Despite this finding, the authors of the large Danish nationwide cohort study noted that TNFi-induced psoriasis is still a rare adverse event. “Practitioners and patients should be aware and observant of the potential for TNFi-associated psoriasis during TNFi treatment but keep in mind that the absolute risk appears to be low,” David Thein, MB, of the department of dermatology at Bispebjerg Hospital, University of Copenhagen, and colleagues wrote in the study.

They analyzed 109,085 patients with RA and IBD enrolled in Danish national registries between 1995 and 2018 without a previous diagnosis of psoriasis, who received either TNFi (20,910 patients) or conventional treatments (108,024 patients) and were followed for 5 years. They were a mean of 50 years old when they started treatment, 62% were women, with 87.8% of patients in the TNFi group receiving prior conventional therapy and 1% of patients in the conventional therapy group receiving prior TNFi treatment.

The investigators assessed the risk of developing any psoriasis, nonpustular psoriasis, and pustular psoriasis in the two groups using ICD-10 codes as well as a record of two consecutive prescriptions for topical vitamin D analogs.

Overall, 1,471 patients (1.4%) developed psoriasis of any type; 1,332 had non-pustular psoriasis, 127 had palmoplantar pustulosis, and 12 had generalized pustulosis.

The incidence rate of developing any psoriasis was 3.0 per 1,000 patient-years (95% confidence interval, 2.9-3.2) for patients receiving conventional therapy and 7.8 per 1,000 patient-years (95% CI, 7.5-8.9) for patients receiving TNFi treatment. Compared with conventional treatment, the risk of developing nonpustular psoriasis was twofold higher among patients receiving TNFi treatment (hazard ratio, 2.12; 95% CI, 1.87-2.40; P < .001). The risk of developing pustular psoriasis was more than sixfold higher among those on a TNFi (HR, 6.50; 95% CI, 4.60-9.23; P < .001).

Dr. Thein and colleagues estimated that the exposure needed to harm 1 additional patient was 241 patient-years for any psoriasis type, 342 patient-years for nonpustular psoriasis, and 909 patient-years for pustular psoriasis, with an estimated absolute risk difference of 5 per 1,000 patient-years.
 

Best evidence to date on risk

Asked to comment on the study findings, Anthony Fernandez, MD, PhD, director of medical dermatology at the Cleveland Clinic, said that he applauded the researchers for performing this well-designed study to determine the risk of TNF inhibitor–induced psoriasis in patients with RA and IBD.

The strengths of the study include excluding patients with a history of psoriasis to rule out disease recurrence and having a large comparator group of patients with IBD and RA who were taking medications other than TNF inhibitors, while one limitation was the potential accuracy of the ICD-10 codes used as the basis for diagnosing psoriasis. “It’s probably closer to the truth of what the true risk is compared to studies done in the past,” he said in an interview.

Dr. Fernandez noted that the results aren’t likely to change how dermatologists, rheumatologists, or gastroenterologists practice, but the message to stay the course in initially treating TNFi-induced psoriasis also holds value. “We don’t need to change anything in our clinical practice when it comes to TNF-alpha inhibitors.”

For patients with RA or IBD who develop TNFi-induced psoriasis with disease that is well controlled with TNFi treatment, keeping them on that treatment is a priority, Dr. Fernandez explained. “The first and foremost goal is, if the TNF inhibitor is working very well to control the disease that it was prescribed for, then you exhaust your efforts to try to control the psoriasis and allow those patients to stay on the TNF inhibitor.”

In his experience, most patients with RA and IBD who develop TNFi-induced psoriasis are controlled with topical medications. Switching to another TNFi is not recommended, he noted, as patients are “likely to have that reaction with any TNF inhibitor.”

However, Dr. Fernandez said that won’t be an option for all patients with RA and IBD. “In some patients you do simply have to stop the TNF inhibitor” and try an alternative treatment with a different mechanism of action.

The cause of TNFi-induced psoriasis is still not well understood. “There certainly is evidence to support that interferon alpha production by plasmacytoid dendritic cells is playing some role in this phenomenon,” but there is “more to the story” and unanswered questions remain, Dr. Fernandez said.

What’s most interesting about this phenomenon, he added, is that “patients can develop it at any time when exposed to a TNF inhibitor.” For instance, most patients develop drug reactions within 2­-3 weeks of starting a treatment, but TNFi-induced psoriasis can appear after a single dose or several years after initiating treatment.

“Why so few patients, and why is there such variability in terms of how long they’re on the TNF inhibitor before the reaction occurs?” he asked. “That really points to ... some other trigger besides exposure to the TNF inhibitor needed for the initiation of this reaction.”

He noted that it would be valuable to identify triggers – or the most likely triggers – which would be challenging, but could “potentially impact clinical practice.”

The authors reported personal and institutional relationships in the form of personal and institutional research grants, honoraria, personal fees, investigator fees paid to university, consultancies, and speaker’s bureau positions for a variety of pharmaceutical companies, data companies, hospitals, and foundations. Dr. Fernandez reported he has nonbranded speaking, consulting, and research relationships with AbbVie and Novartis; and is a consultant for UCB, Bristol-Myers Squibb, and Boehringer Ingelheim on related products.

Patients with rheumatoid arthritis or inflammatory bowel disease (IBD) taking a tumor necrosis factor–alpha inhibitor (TNFi) have about a two-fold higher risk of developing psoriasis, compared with patients receiving conventional treatment, according to a new study published in JAMA Dermatology.

Despite this finding, the authors of the large Danish nationwide cohort study noted that TNFi-induced psoriasis is still a rare adverse event. “Practitioners and patients should be aware and observant of the potential for TNFi-associated psoriasis during TNFi treatment but keep in mind that the absolute risk appears to be low,” David Thein, MB, of the department of dermatology at Bispebjerg Hospital, University of Copenhagen, and colleagues wrote in the study.

They analyzed 109,085 patients with RA and IBD enrolled in Danish national registries between 1995 and 2018 without a previous diagnosis of psoriasis, who received either TNFi (20,910 patients) or conventional treatments (108,024 patients) and were followed for 5 years. They were a mean of 50 years old when they started treatment, 62% were women, with 87.8% of patients in the TNFi group receiving prior conventional therapy and 1% of patients in the conventional therapy group receiving prior TNFi treatment.

The investigators assessed the risk of developing any psoriasis, nonpustular psoriasis, and pustular psoriasis in the two groups using ICD-10 codes as well as a record of two consecutive prescriptions for topical vitamin D analogs.

Overall, 1,471 patients (1.4%) developed psoriasis of any type; 1,332 had non-pustular psoriasis, 127 had palmoplantar pustulosis, and 12 had generalized pustulosis.

The incidence rate of developing any psoriasis was 3.0 per 1,000 patient-years (95% confidence interval, 2.9-3.2) for patients receiving conventional therapy and 7.8 per 1,000 patient-years (95% CI, 7.5-8.9) for patients receiving TNFi treatment. Compared with conventional treatment, the risk of developing nonpustular psoriasis was twofold higher among patients receiving TNFi treatment (hazard ratio, 2.12; 95% CI, 1.87-2.40; P < .001). The risk of developing pustular psoriasis was more than sixfold higher among those on a TNFi (HR, 6.50; 95% CI, 4.60-9.23; P < .001).

Dr. Thein and colleagues estimated that the exposure needed to harm 1 additional patient was 241 patient-years for any psoriasis type, 342 patient-years for nonpustular psoriasis, and 909 patient-years for pustular psoriasis, with an estimated absolute risk difference of 5 per 1,000 patient-years.
 

Best evidence to date on risk

Asked to comment on the study findings, Anthony Fernandez, MD, PhD, director of medical dermatology at the Cleveland Clinic, said that he applauded the researchers for performing this well-designed study to determine the risk of TNF inhibitor–induced psoriasis in patients with RA and IBD.

The strengths of the study include excluding patients with a history of psoriasis to rule out disease recurrence and having a large comparator group of patients with IBD and RA who were taking medications other than TNF inhibitors, while one limitation was the potential accuracy of the ICD-10 codes used as the basis for diagnosing psoriasis. “It’s probably closer to the truth of what the true risk is compared to studies done in the past,” he said in an interview.

Dr. Fernandez noted that the results aren’t likely to change how dermatologists, rheumatologists, or gastroenterologists practice, but the message to stay the course in initially treating TNFi-induced psoriasis also holds value. “We don’t need to change anything in our clinical practice when it comes to TNF-alpha inhibitors.”

For patients with RA or IBD who develop TNFi-induced psoriasis with disease that is well controlled with TNFi treatment, keeping them on that treatment is a priority, Dr. Fernandez explained. “The first and foremost goal is, if the TNF inhibitor is working very well to control the disease that it was prescribed for, then you exhaust your efforts to try to control the psoriasis and allow those patients to stay on the TNF inhibitor.”

In his experience, most patients with RA and IBD who develop TNFi-induced psoriasis are controlled with topical medications. Switching to another TNFi is not recommended, he noted, as patients are “likely to have that reaction with any TNF inhibitor.”

However, Dr. Fernandez said that won’t be an option for all patients with RA and IBD. “In some patients you do simply have to stop the TNF inhibitor” and try an alternative treatment with a different mechanism of action.

The cause of TNFi-induced psoriasis is still not well understood. “There certainly is evidence to support that interferon alpha production by plasmacytoid dendritic cells is playing some role in this phenomenon,” but there is “more to the story” and unanswered questions remain, Dr. Fernandez said.

What’s most interesting about this phenomenon, he added, is that “patients can develop it at any time when exposed to a TNF inhibitor.” For instance, most patients develop drug reactions within 2­-3 weeks of starting a treatment, but TNFi-induced psoriasis can appear after a single dose or several years after initiating treatment.

“Why so few patients, and why is there such variability in terms of how long they’re on the TNF inhibitor before the reaction occurs?” he asked. “That really points to ... some other trigger besides exposure to the TNF inhibitor needed for the initiation of this reaction.”

He noted that it would be valuable to identify triggers – or the most likely triggers – which would be challenging, but could “potentially impact clinical practice.”

The authors reported personal and institutional relationships in the form of personal and institutional research grants, honoraria, personal fees, investigator fees paid to university, consultancies, and speaker’s bureau positions for a variety of pharmaceutical companies, data companies, hospitals, and foundations. Dr. Fernandez reported he has nonbranded speaking, consulting, and research relationships with AbbVie and Novartis; and is a consultant for UCB, Bristol-Myers Squibb, and Boehringer Ingelheim on related products.

Compulsivity is a significant contributor to disability and poor quality of life for individuals with trichotillomania (TTM) and skin-picking disorder (SPD), based on data from 91 adults.

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.

Compulsivity is a significant contributor to disability and poor quality of life for individuals with trichotillomania (TTM) and skin-picking disorder (SPD), based on data from 91 adults.

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.

Compulsivity is a significant contributor to disability and poor quality of life for individuals with trichotillomania (TTM) and skin-picking disorder (SPD), based on data from 91 adults.

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.