Postpartum depression risk increased among sexual minority women

Article Type
Changed
Tue, 08/15/2023 - 09:48

Cisgender women who identify as sexual minorities may have an increased risk of postpartum depression compared with heterosexual women, new research shows. However, with sexual orientation highly underdocumented among women giving birth, understanding of the prevalence is lacking.

“To our knowledge, this cohort study was the first to examine perinatal depression screening and symptom endorsement among sexual minority women in a major medical center in the U.S.,” reported the authors of the study published in JAMA Psychiatry.

The results “highlight the need for investigations that include strategies for measuring sexual orientation because reliance on medical record review has substantial limitations with regard to the research questions and the validity of the data,” they noted.

Clinical guidelines recommend universal perinatal depression screening at obstetric and pediatric well-infant visits; however, there are significant gaps in data on the issue when it comes to sexual minority women.

To assess the prevalence of sexual minority people giving birth and compare perinatal depression screening rates and scores with those of heterosexual cisgender women, the authors conducted a review of medical records of 18,243 female patients who gave birth at a large, diverse, university-based medical center in Chicago between January and December of 2019.

Of the patients, 57.3% of whom were non-Hispanic White, 1.5% (280) had documentation of their sexual orientation, or sexual minority status.

The results show that those identified as being in sexual minorities, including lesbian, bisexual, queer, pansexual or asexual, were more likely than were heterosexual women to be more engaged in their care – they were more likely to have attended at least one prenatal visit (20.0% vs. 13.7%; P = .002) and at least one postpartum care visit (18.6% vs. 12.8%; P = .004), and more likely to be screened for depression during postpartum care (odds ratio, 1.77; P = .002).

Sexual minority women were also significantly more likely to screen positive for depression during the postpartum period than were heterosexual women (odds ratio, 2.38; P = .03); however, all other comparisons were not significantly different.

The finding regarding postpartum depression was consistent with recent literature, including a systematic review indicating that the stress of being in a sexual minority may be heightened during the postpartum period, the authors noted.

Reasons for the heightened stress may include “being perceived as inadequate parents, heteronormativity in perinatal care, such as intake forms asking for information about the child’s father, and lack of familial social support due to nonacceptance of the parents’ sexual orientation,” the researchers explained.

The rate of only 1.5% of people giving birth who identified as a sexual minority was significantly lower than expected, and much lower that the 17% reported in a recent nationally representative sample of women, first author Leiszle Lapping-Carr, PhD, director of the sexual and relationship health program, department of psychiatry and behavioral sciences, Northwestern University, Chicago, said in an interview.

“I did not expect a rate as low at 1.5%,” she said. “I anticipated it would not be as high as the 17%, but this was quite low. I think one primary reason is that women are not interested in disclosing their sexual orientation to their ob.gyns. if they don’t have to.”

Furthermore, Dr. Lapping-Carr said, “most medical systems do not have an easy way to document sexual orientation or gender identity, and even if it exists many physicians are unaware of the process.”

On a broader level, the lower rates may be indicative of a lack of acknowledgment of sexual minorities in the ob.gyn. setting, Dr. Lapping-Carr added.

Dr. Lapping-Carr
Dr. Leiszle Lapping-Carr


“There is a heteronormative bias implicit in most obstetrics clinics, in which pregnant people are automatically gendered as women and assumed to be heterosexual, especially if they present with a male partner,” she said.

Because of those factors, even if a pregnant person discloses sexual identity, that person may request that it not be documented in the chart, she noted.

The higher rates of postpartum depression are consistent with higher rates of mental illness that are reported in general among sexual minority women, pregnant or not, including depression, anxiety, higher rates of substance abuse, stressful life events, and intimate partner violence, compared with heterosexual women, the authors noted.
 

 

 

Develop more supportive systems

To address postpartum depression among sexual minority women, Dr. Lapping-Carr suggested that clinicians generally start by avoiding language and behaviors that could suggest the potential bias that sexual minority patients can face.

“The main change [in treatment] that would likely be helpful for postpartum depression treatment is removing heteronormative language, e.g., not referring to partners as ‘fathers,’ ” she said.

Also, patients may benefit from “discussion of issues of relevance to people with sexual minority identities, such as the process of adoption for female non-birthing partners,” Dr. Lapping-Carr added.

“Starting to create spaces that are inclusive and welcoming for people of all identities will go a long way in increasing your patient’s trust in you,” she said.

While there is a lack of published data regarding increases in rates of sexual minority patients who are giving birth, societal trends suggest the rates may likely be on the rise, Dr. Lapping-Carr said.

“We do know that among adolescents, endorsement of sexual and gender minority identities is much higher than in previous generations, so it would follow that the proportion of birthing people with sexual and gender minority identities would also increase,” she said.

Commenting on the study, K. Ashley Brandt, DO, obstetrics section chief and medical director of Gender Affirming Surgery at Reading Hospital, in West Reading, Pa., noted that limitations include a lack of information about the bigger picture of patients’ risk factors.

“There is no documentation of other risks factors, including rates of depression in the antenatal period, which is higher in LGBTQ individuals and also a risk factor for postpartum depression,” Dr. Brandt told this news organization.

She agreed, however, that patients may be reluctant to report their sexual minority status on the record – but such issues are often addressed.

Dr. K. Ashley Brandt

“I believe that obstetricians do ask this question far more than other providers, but it may not be easily captured in medical records, and patients may also hesitate to disclose sexual practices and sexual orientation due to fear of medical discrimination, which is still extremely prevalent,” Dr. Brandt said. 

The study underscores, however, that “same-sex parents are a reality that providers will face,” she said. “They have unique social determinants for health that often go undocumented and unaddressed, which could contribute to higher rates of depression in the postpartum period.”

Factors that may be ignored or undocumented, such as sexual minorities’ religious beliefs or social and familial support, can play significant roles in health care outcomes, Dr. Brandt added.

“Providers need to find ways to better educate themselves about LGBTQ individuals and develop more supportive systems to ensure patients feel safe in disclosing their identities.”  

The authors and Dr. Brandt had no disclosures to report.

Publications
Topics
Sections

Cisgender women who identify as sexual minorities may have an increased risk of postpartum depression compared with heterosexual women, new research shows. However, with sexual orientation highly underdocumented among women giving birth, understanding of the prevalence is lacking.

“To our knowledge, this cohort study was the first to examine perinatal depression screening and symptom endorsement among sexual minority women in a major medical center in the U.S.,” reported the authors of the study published in JAMA Psychiatry.

The results “highlight the need for investigations that include strategies for measuring sexual orientation because reliance on medical record review has substantial limitations with regard to the research questions and the validity of the data,” they noted.

Clinical guidelines recommend universal perinatal depression screening at obstetric and pediatric well-infant visits; however, there are significant gaps in data on the issue when it comes to sexual minority women.

To assess the prevalence of sexual minority people giving birth and compare perinatal depression screening rates and scores with those of heterosexual cisgender women, the authors conducted a review of medical records of 18,243 female patients who gave birth at a large, diverse, university-based medical center in Chicago between January and December of 2019.

Of the patients, 57.3% of whom were non-Hispanic White, 1.5% (280) had documentation of their sexual orientation, or sexual minority status.

The results show that those identified as being in sexual minorities, including lesbian, bisexual, queer, pansexual or asexual, were more likely than were heterosexual women to be more engaged in their care – they were more likely to have attended at least one prenatal visit (20.0% vs. 13.7%; P = .002) and at least one postpartum care visit (18.6% vs. 12.8%; P = .004), and more likely to be screened for depression during postpartum care (odds ratio, 1.77; P = .002).

Sexual minority women were also significantly more likely to screen positive for depression during the postpartum period than were heterosexual women (odds ratio, 2.38; P = .03); however, all other comparisons were not significantly different.

The finding regarding postpartum depression was consistent with recent literature, including a systematic review indicating that the stress of being in a sexual minority may be heightened during the postpartum period, the authors noted.

Reasons for the heightened stress may include “being perceived as inadequate parents, heteronormativity in perinatal care, such as intake forms asking for information about the child’s father, and lack of familial social support due to nonacceptance of the parents’ sexual orientation,” the researchers explained.

The rate of only 1.5% of people giving birth who identified as a sexual minority was significantly lower than expected, and much lower that the 17% reported in a recent nationally representative sample of women, first author Leiszle Lapping-Carr, PhD, director of the sexual and relationship health program, department of psychiatry and behavioral sciences, Northwestern University, Chicago, said in an interview.

“I did not expect a rate as low at 1.5%,” she said. “I anticipated it would not be as high as the 17%, but this was quite low. I think one primary reason is that women are not interested in disclosing their sexual orientation to their ob.gyns. if they don’t have to.”

Furthermore, Dr. Lapping-Carr said, “most medical systems do not have an easy way to document sexual orientation or gender identity, and even if it exists many physicians are unaware of the process.”

On a broader level, the lower rates may be indicative of a lack of acknowledgment of sexual minorities in the ob.gyn. setting, Dr. Lapping-Carr added.

Dr. Lapping-Carr
Dr. Leiszle Lapping-Carr


“There is a heteronormative bias implicit in most obstetrics clinics, in which pregnant people are automatically gendered as women and assumed to be heterosexual, especially if they present with a male partner,” she said.

Because of those factors, even if a pregnant person discloses sexual identity, that person may request that it not be documented in the chart, she noted.

The higher rates of postpartum depression are consistent with higher rates of mental illness that are reported in general among sexual minority women, pregnant or not, including depression, anxiety, higher rates of substance abuse, stressful life events, and intimate partner violence, compared with heterosexual women, the authors noted.
 

 

 

Develop more supportive systems

To address postpartum depression among sexual minority women, Dr. Lapping-Carr suggested that clinicians generally start by avoiding language and behaviors that could suggest the potential bias that sexual minority patients can face.

“The main change [in treatment] that would likely be helpful for postpartum depression treatment is removing heteronormative language, e.g., not referring to partners as ‘fathers,’ ” she said.

Also, patients may benefit from “discussion of issues of relevance to people with sexual minority identities, such as the process of adoption for female non-birthing partners,” Dr. Lapping-Carr added.

“Starting to create spaces that are inclusive and welcoming for people of all identities will go a long way in increasing your patient’s trust in you,” she said.

While there is a lack of published data regarding increases in rates of sexual minority patients who are giving birth, societal trends suggest the rates may likely be on the rise, Dr. Lapping-Carr said.

“We do know that among adolescents, endorsement of sexual and gender minority identities is much higher than in previous generations, so it would follow that the proportion of birthing people with sexual and gender minority identities would also increase,” she said.

Commenting on the study, K. Ashley Brandt, DO, obstetrics section chief and medical director of Gender Affirming Surgery at Reading Hospital, in West Reading, Pa., noted that limitations include a lack of information about the bigger picture of patients’ risk factors.

“There is no documentation of other risks factors, including rates of depression in the antenatal period, which is higher in LGBTQ individuals and also a risk factor for postpartum depression,” Dr. Brandt told this news organization.

She agreed, however, that patients may be reluctant to report their sexual minority status on the record – but such issues are often addressed.

Dr. K. Ashley Brandt

“I believe that obstetricians do ask this question far more than other providers, but it may not be easily captured in medical records, and patients may also hesitate to disclose sexual practices and sexual orientation due to fear of medical discrimination, which is still extremely prevalent,” Dr. Brandt said. 

The study underscores, however, that “same-sex parents are a reality that providers will face,” she said. “They have unique social determinants for health that often go undocumented and unaddressed, which could contribute to higher rates of depression in the postpartum period.”

Factors that may be ignored or undocumented, such as sexual minorities’ religious beliefs or social and familial support, can play significant roles in health care outcomes, Dr. Brandt added.

“Providers need to find ways to better educate themselves about LGBTQ individuals and develop more supportive systems to ensure patients feel safe in disclosing their identities.”  

The authors and Dr. Brandt had no disclosures to report.

Cisgender women who identify as sexual minorities may have an increased risk of postpartum depression compared with heterosexual women, new research shows. However, with sexual orientation highly underdocumented among women giving birth, understanding of the prevalence is lacking.

“To our knowledge, this cohort study was the first to examine perinatal depression screening and symptom endorsement among sexual minority women in a major medical center in the U.S.,” reported the authors of the study published in JAMA Psychiatry.

The results “highlight the need for investigations that include strategies for measuring sexual orientation because reliance on medical record review has substantial limitations with regard to the research questions and the validity of the data,” they noted.

Clinical guidelines recommend universal perinatal depression screening at obstetric and pediatric well-infant visits; however, there are significant gaps in data on the issue when it comes to sexual minority women.

To assess the prevalence of sexual minority people giving birth and compare perinatal depression screening rates and scores with those of heterosexual cisgender women, the authors conducted a review of medical records of 18,243 female patients who gave birth at a large, diverse, university-based medical center in Chicago between January and December of 2019.

Of the patients, 57.3% of whom were non-Hispanic White, 1.5% (280) had documentation of their sexual orientation, or sexual minority status.

The results show that those identified as being in sexual minorities, including lesbian, bisexual, queer, pansexual or asexual, were more likely than were heterosexual women to be more engaged in their care – they were more likely to have attended at least one prenatal visit (20.0% vs. 13.7%; P = .002) and at least one postpartum care visit (18.6% vs. 12.8%; P = .004), and more likely to be screened for depression during postpartum care (odds ratio, 1.77; P = .002).

Sexual minority women were also significantly more likely to screen positive for depression during the postpartum period than were heterosexual women (odds ratio, 2.38; P = .03); however, all other comparisons were not significantly different.

The finding regarding postpartum depression was consistent with recent literature, including a systematic review indicating that the stress of being in a sexual minority may be heightened during the postpartum period, the authors noted.

Reasons for the heightened stress may include “being perceived as inadequate parents, heteronormativity in perinatal care, such as intake forms asking for information about the child’s father, and lack of familial social support due to nonacceptance of the parents’ sexual orientation,” the researchers explained.

The rate of only 1.5% of people giving birth who identified as a sexual minority was significantly lower than expected, and much lower that the 17% reported in a recent nationally representative sample of women, first author Leiszle Lapping-Carr, PhD, director of the sexual and relationship health program, department of psychiatry and behavioral sciences, Northwestern University, Chicago, said in an interview.

“I did not expect a rate as low at 1.5%,” she said. “I anticipated it would not be as high as the 17%, but this was quite low. I think one primary reason is that women are not interested in disclosing their sexual orientation to their ob.gyns. if they don’t have to.”

Furthermore, Dr. Lapping-Carr said, “most medical systems do not have an easy way to document sexual orientation or gender identity, and even if it exists many physicians are unaware of the process.”

On a broader level, the lower rates may be indicative of a lack of acknowledgment of sexual minorities in the ob.gyn. setting, Dr. Lapping-Carr added.

Dr. Lapping-Carr
Dr. Leiszle Lapping-Carr


“There is a heteronormative bias implicit in most obstetrics clinics, in which pregnant people are automatically gendered as women and assumed to be heterosexual, especially if they present with a male partner,” she said.

Because of those factors, even if a pregnant person discloses sexual identity, that person may request that it not be documented in the chart, she noted.

The higher rates of postpartum depression are consistent with higher rates of mental illness that are reported in general among sexual minority women, pregnant or not, including depression, anxiety, higher rates of substance abuse, stressful life events, and intimate partner violence, compared with heterosexual women, the authors noted.
 

 

 

Develop more supportive systems

To address postpartum depression among sexual minority women, Dr. Lapping-Carr suggested that clinicians generally start by avoiding language and behaviors that could suggest the potential bias that sexual minority patients can face.

“The main change [in treatment] that would likely be helpful for postpartum depression treatment is removing heteronormative language, e.g., not referring to partners as ‘fathers,’ ” she said.

Also, patients may benefit from “discussion of issues of relevance to people with sexual minority identities, such as the process of adoption for female non-birthing partners,” Dr. Lapping-Carr added.

“Starting to create spaces that are inclusive and welcoming for people of all identities will go a long way in increasing your patient’s trust in you,” she said.

While there is a lack of published data regarding increases in rates of sexual minority patients who are giving birth, societal trends suggest the rates may likely be on the rise, Dr. Lapping-Carr said.

“We do know that among adolescents, endorsement of sexual and gender minority identities is much higher than in previous generations, so it would follow that the proportion of birthing people with sexual and gender minority identities would also increase,” she said.

Commenting on the study, K. Ashley Brandt, DO, obstetrics section chief and medical director of Gender Affirming Surgery at Reading Hospital, in West Reading, Pa., noted that limitations include a lack of information about the bigger picture of patients’ risk factors.

“There is no documentation of other risks factors, including rates of depression in the antenatal period, which is higher in LGBTQ individuals and also a risk factor for postpartum depression,” Dr. Brandt told this news organization.

She agreed, however, that patients may be reluctant to report their sexual minority status on the record – but such issues are often addressed.

Dr. K. Ashley Brandt

“I believe that obstetricians do ask this question far more than other providers, but it may not be easily captured in medical records, and patients may also hesitate to disclose sexual practices and sexual orientation due to fear of medical discrimination, which is still extremely prevalent,” Dr. Brandt said. 

The study underscores, however, that “same-sex parents are a reality that providers will face,” she said. “They have unique social determinants for health that often go undocumented and unaddressed, which could contribute to higher rates of depression in the postpartum period.”

Factors that may be ignored or undocumented, such as sexual minorities’ religious beliefs or social and familial support, can play significant roles in health care outcomes, Dr. Brandt added.

“Providers need to find ways to better educate themselves about LGBTQ individuals and develop more supportive systems to ensure patients feel safe in disclosing their identities.”  

The authors and Dr. Brandt had no disclosures to report.

Publications
Publications
Topics
Article Type
Sections
Article Source

FROM JAMA PSYCHIATRY

Disallow All Ads
Content Gating
No Gating (article Unlocked/Free)
Alternative CME
Disqus Comments
Default
Use ProPublica
Hide sidebar & use full width
render the right sidebar.
Conference Recap Checkbox
Not Conference Recap
Clinical Edge
Display the Slideshow in this Article
Medscape Article
Display survey writer
Reuters content
Disable Inline Native ads
WebMD Article

New weight loss drugs appeal to half of U.S. adults

Article Type
Changed
Tue, 08/15/2023 - 09:41

The new generation of safe and effective weight loss drugs seems to have helped boost the U.S. profile of such medications and has fueled interest in nearly half the U.S. adult population.

A recent survey of more than 1,000 U.S. adults showed that 18% were “somewhat interested” in taking a “safe, effective” weight loss drug, 27% were “very interested,” and 4% said they were already using such an agent, together constituting 49% of the surveyed adults.

The newer, more potent and generally safe agents that work by stimulating receptors to nutrient-stimulated hormones, such as incretins like glucagonlike peptide–1, seem to drive this interest.

When asked: “How much have you heard, if anything, about a new class of drugs being used for weight loss, such as Ozempic [semaglutide formulated and approved for people with type 2 diabetes], Wegovy [semaglutide for weight loss], and Mounjaro [tirzepatide, currently approved for treating only people with type 2 diabetes]?” 43% said they had heard some, or a lot, about these agents.

This was particularly true among people at least 65 years old, who had a 55% prevalence of knowing some, or a lot, about these new weight-loss agents, while an additional 26% had heard at least “a little” about them, reported staff members of KFF (formerly the Kaiser Family Foundation) in a report posted online in early August. 
 

Weight loss drugs garner ‘increasing’ attention

“A new class of prescription drugs, initially developed to treat type 2 diabetes, have been garnering an increasing amount of attention due to their ability to act as highly effective weight loss drugs for overweight or obese adults,” wrote the report’s authors.

However, surveyed interest fell markedly when respondents answered further questions that hinged on certain limitations of the newer weight loss formulations.

For example, the percent interested held nearly steady, at 44%, when told the weight loss agent in question was an oral pill, but when asked about formulations requiring weekly injections the prevalence of people who had some interest, or were very interested, dropped to 23%. And when presented with the premise that they would need to take the drug chronically to keep their weight off and that stopping the agent would mean weight regain, those with “higher levels of interest” in the agent fell to 14% of the study sample.

Other deal breakers for most survey respondents were lack of a weight-loss indication approved by the Food and Drug Administration, a hypothetical that left 16% still somewhat or very interested, and lack of insurance coverage, which also dropped the higher interest levels to 16% of respondents. On the flip side of that sentiment, 80% of survey respondents believe that health insurance should cover the cost for a prescription weight loss drug for people with overweight or obesity.

The survey was designed and analyzed by public-opinion researchers at KFF and run both online and by telephone in both English and Spanish during July 11-19, 2023. The margin of sampling error was plus or minus 3 percentage points for the full sample but may have been even higher for results based on subgroup analyses.

The survey report includes no funding or disclosure information. However, KFF describes itself as “independent” and “nonpartisan” and that it “does everything based on facts and data, and we do so objectively without taking policy positions and without affiliation to any political party or external interest.”

A version of this article first appeared on Medscape.com.

Publications
Topics
Sections

The new generation of safe and effective weight loss drugs seems to have helped boost the U.S. profile of such medications and has fueled interest in nearly half the U.S. adult population.

A recent survey of more than 1,000 U.S. adults showed that 18% were “somewhat interested” in taking a “safe, effective” weight loss drug, 27% were “very interested,” and 4% said they were already using such an agent, together constituting 49% of the surveyed adults.

The newer, more potent and generally safe agents that work by stimulating receptors to nutrient-stimulated hormones, such as incretins like glucagonlike peptide–1, seem to drive this interest.

When asked: “How much have you heard, if anything, about a new class of drugs being used for weight loss, such as Ozempic [semaglutide formulated and approved for people with type 2 diabetes], Wegovy [semaglutide for weight loss], and Mounjaro [tirzepatide, currently approved for treating only people with type 2 diabetes]?” 43% said they had heard some, or a lot, about these agents.

This was particularly true among people at least 65 years old, who had a 55% prevalence of knowing some, or a lot, about these new weight-loss agents, while an additional 26% had heard at least “a little” about them, reported staff members of KFF (formerly the Kaiser Family Foundation) in a report posted online in early August. 
 

Weight loss drugs garner ‘increasing’ attention

“A new class of prescription drugs, initially developed to treat type 2 diabetes, have been garnering an increasing amount of attention due to their ability to act as highly effective weight loss drugs for overweight or obese adults,” wrote the report’s authors.

However, surveyed interest fell markedly when respondents answered further questions that hinged on certain limitations of the newer weight loss formulations.

For example, the percent interested held nearly steady, at 44%, when told the weight loss agent in question was an oral pill, but when asked about formulations requiring weekly injections the prevalence of people who had some interest, or were very interested, dropped to 23%. And when presented with the premise that they would need to take the drug chronically to keep their weight off and that stopping the agent would mean weight regain, those with “higher levels of interest” in the agent fell to 14% of the study sample.

Other deal breakers for most survey respondents were lack of a weight-loss indication approved by the Food and Drug Administration, a hypothetical that left 16% still somewhat or very interested, and lack of insurance coverage, which also dropped the higher interest levels to 16% of respondents. On the flip side of that sentiment, 80% of survey respondents believe that health insurance should cover the cost for a prescription weight loss drug for people with overweight or obesity.

The survey was designed and analyzed by public-opinion researchers at KFF and run both online and by telephone in both English and Spanish during July 11-19, 2023. The margin of sampling error was plus or minus 3 percentage points for the full sample but may have been even higher for results based on subgroup analyses.

The survey report includes no funding or disclosure information. However, KFF describes itself as “independent” and “nonpartisan” and that it “does everything based on facts and data, and we do so objectively without taking policy positions and without affiliation to any political party or external interest.”

A version of this article first appeared on Medscape.com.

The new generation of safe and effective weight loss drugs seems to have helped boost the U.S. profile of such medications and has fueled interest in nearly half the U.S. adult population.

A recent survey of more than 1,000 U.S. adults showed that 18% were “somewhat interested” in taking a “safe, effective” weight loss drug, 27% were “very interested,” and 4% said they were already using such an agent, together constituting 49% of the surveyed adults.

The newer, more potent and generally safe agents that work by stimulating receptors to nutrient-stimulated hormones, such as incretins like glucagonlike peptide–1, seem to drive this interest.

When asked: “How much have you heard, if anything, about a new class of drugs being used for weight loss, such as Ozempic [semaglutide formulated and approved for people with type 2 diabetes], Wegovy [semaglutide for weight loss], and Mounjaro [tirzepatide, currently approved for treating only people with type 2 diabetes]?” 43% said they had heard some, or a lot, about these agents.

This was particularly true among people at least 65 years old, who had a 55% prevalence of knowing some, or a lot, about these new weight-loss agents, while an additional 26% had heard at least “a little” about them, reported staff members of KFF (formerly the Kaiser Family Foundation) in a report posted online in early August. 
 

Weight loss drugs garner ‘increasing’ attention

“A new class of prescription drugs, initially developed to treat type 2 diabetes, have been garnering an increasing amount of attention due to their ability to act as highly effective weight loss drugs for overweight or obese adults,” wrote the report’s authors.

However, surveyed interest fell markedly when respondents answered further questions that hinged on certain limitations of the newer weight loss formulations.

For example, the percent interested held nearly steady, at 44%, when told the weight loss agent in question was an oral pill, but when asked about formulations requiring weekly injections the prevalence of people who had some interest, or were very interested, dropped to 23%. And when presented with the premise that they would need to take the drug chronically to keep their weight off and that stopping the agent would mean weight regain, those with “higher levels of interest” in the agent fell to 14% of the study sample.

Other deal breakers for most survey respondents were lack of a weight-loss indication approved by the Food and Drug Administration, a hypothetical that left 16% still somewhat or very interested, and lack of insurance coverage, which also dropped the higher interest levels to 16% of respondents. On the flip side of that sentiment, 80% of survey respondents believe that health insurance should cover the cost for a prescription weight loss drug for people with overweight or obesity.

The survey was designed and analyzed by public-opinion researchers at KFF and run both online and by telephone in both English and Spanish during July 11-19, 2023. The margin of sampling error was plus or minus 3 percentage points for the full sample but may have been even higher for results based on subgroup analyses.

The survey report includes no funding or disclosure information. However, KFF describes itself as “independent” and “nonpartisan” and that it “does everything based on facts and data, and we do so objectively without taking policy positions and without affiliation to any political party or external interest.”

A version of this article first appeared on Medscape.com.

Publications
Publications
Topics
Article Type
Sections
Disallow All Ads
Content Gating
No Gating (article Unlocked/Free)
Alternative CME
Disqus Comments
Default
Use ProPublica
Hide sidebar & use full width
render the right sidebar.
Conference Recap Checkbox
Not Conference Recap
Clinical Edge
Display the Slideshow in this Article
Medscape Article
Display survey writer
Reuters content
Disable Inline Native ads
WebMD Article

Too old for time out. Now what? Oppositional behavior in school-age children

Article Type
Changed
Tue, 08/15/2023 - 09:34

The best plan for oppositional behavior in a school-aged child is prevention at younger ages! But here is the family coming to see us, struggling to get cooperation, and often increasingly embarrassed and angry.

Sometimes the dynamics leading to this behavior seem obvious: the parent tells their child to put away the toys they have pulled out in your waiting room, is ignored, and cleans them up themselves without a word. The child smugly fiddles with their cell phone, reinforced by removal of the task. Even without a defined reward, this still constitutes positive reinforcement as it increases the likelihood of the same future behavior of ignoring a parental directive.

Dr. Barbara J. Howard

Preventing this “mild” oppositionality at a younger age may come from the parent jollying the child through the clean up, participating with them in a game-like way counting the toys or making it a race, or even using only one request before grasping the child’s hand and “assisting” them in picking up a toy while praising cooperation but these tactics become less appropriate with age.

Other factors that may have led to school-aged child refusal include yelling at them, shaming, comparing them with a more compliant sibling, threatening a punishment that is never carried out, or deferring a consequence to the other caregiver. Of course, no child would want to please a caregiver with this kind of interaction by obeying them. By school age, children have a greater need to exert autonomy and avoid humiliation and may do this by getting angry, talking back, insulting the parent, or leaving the scene. This is especially likely if peers or siblings are present and the child wants to show that they can’t be bossed around.
 

Practical advice

So what can we advise when habits of refusal have already been established? Keeping in mind the major school-age psychosocial tasks of developing autonomy and self-esteem, the parent may need to overdo opportunities for this child to have choices and experience respect. When the child has a generalized oppositional stance, the parent may feel that it is difficult to identify opportunities to do this. The key in that case is to set up for cooperation and focus on small positive or neutral bits of behavior to reinforce. For example, requesting that the child do something they want to do anyways, such as come for a snack or turn on the TV, can be met with a brief but sincere “thanks” or “thanks for hopping on that.”

Sarcasm is counterproductive at all times, as it is insulting. Asking the child’s opinion regularly then listening and reflecting, rephrasing what they said, and even checking to see if the parent “got it right” do not require that the parent agrees. Any disagreement that the parent feels is needed can be withheld for a few minutes to indicate respect for the child’s opinion. For a child to learn to make “good choices” of behavior comes also from noticing how “not so good choices” worked out, a reflection the parent can try to elicit nonjudgmentally. Rebuilding the relationship can be done over time with respectful communication and assuring daily times of showing interest in the child, fooling around together, or playing a game.

While giving more choices respects autonomy, the options must really be acceptable to the parent. They may allow the child to choose some aspects of family activities – a skate park, or a certain eatery, or parts of the outing could be optional. Sometimes the order of upcoming events can provide a choice even if attendance is required. Sometimes the dress code can be flexible (flip flops, okay sure!), or a friend (preferably a well-behaved one!) could be invited along.
 

 

 

Pitfalls to avoid

Avoiding humiliation may be obvious, such as not complementing a singing performance or insistence on the child self-reporting bad behavior. For some families the parents may need to avoid their own embarrassing habits of “bad jokes” or outlandish clothes as a reasonable accommodation. Other kinds of humiliation to avoid may be specific to the child’s weaknesses, such as insisting that a clumsy child play on a team or a shy child speak to strangers. While it may be valuable for the child to work on those weaknesses, this should be done in private, if possible, or even with a coach who is not the parent if the relationship is strained.

Sensitive or anxious children are more prone to embarrassment and may then react with oppositional responses. They often do better with notice or coaching for upcoming events that may be in a category that has upset them in the past; for example, a visit from an overly affectionate aunt. Children may gain respect for their parents by being given a task that serves as an early escape route for these situations (Oh, would you please run out to the car and get my sweater?) although progressively tolerating undesirable situations is also important practice. A kindly debrief later with praise for progress also builds skills.
 

Reinforcing behaviors and revisiting consequences

Gaining more privileges as the reward for cooperation and responsibility is the natural sequence with development but oppositional children may need a chart, ideally negotiated as a family, to be clear about this cause-effect plan and what is expected for them to earn more freedom. Another benefit of a chart is that it is an objective translator of rules that can literally be pointed to rather than a parent-child conversation that could become an argument. Parents need to make expectations clear and follow through on promised increased privileges or consequences to be seen as fair. Having regular routines for chores, not just for activities, reduces refusal as well. Such concrete steps are especially important for children with ADHD who are often easily distracted from parental requests even if they meant to follow them and have a weak sense of timing. I have seen some wise parents give their distracted or impulsive child “a minute to decide if that is their final choice” before levying a consequence.

“When-then” statements can be useful both for coaching appropriate behavior in advance, debriefs, and alerting to consequences when needed. For example: “When you ask your aunt a question right away when you meet her then her hugs will be shorter” is coaching. “When you come home an hour late then you will have an hour earlier curfew the next week” is a graded consequence.
 

The cell phone issue

I can’t omit mentioning the specific situation of a child on a cell phone or tablet ignoring or refusing requests. While having possession of such a device may be seen as a safety measure (How can he reach me?) and social coinage (All my friends have one!), they are distracting and addicting and now the most common reason I see for oppositional interactions. This has been discussed elsewhere, so let me just say that a device is a privilege and should not “belong” to a child. Delaying the age of “lending” the device, establishing rules for use to certain situations and durations, and removing it for defined periods if it is interfering with cooperation are basic principles, even though enforcing them may result in upsets. Parents may need to change their own device use to be able to address oppositional behavior in their child.

 

 

Strategies for building better behavior

How important is it for the parent to verbalize what they are doing to instruct or accommodate their school-aged child? In the presence of others, the fewer words highlighting that an intervention is underway the better. Sometimes having a secret signal to prompt or praise, even a wink, can be helpful without being humiliating. These should be decided on together in private and practiced at first in nonstressful situations. Comments of appreciation or praise are appropriate then and are often reinforcing but should be very specific; for example, “I’m glad you got ready right away when it was time to leave” rather than general or backwards praise “Ready on time today, huh?” For some, especially younger or special-needs children, marks, points, tickets, tokens, or little prizes may be beneficial reinforcers, especially when trying to establish new patterns of interaction. Praise should fairly quickly replace more concrete rewards, though, by weaning, first by intermittent delivery or spacing further apart.

When counseling about oppositional behavior in school-aged children eliciting specific examples is key to determining whether parents are overly rigid or lax, have realistic expectations for their individual child’s temperament, skills, and past experiences (for example, traumas). As Ross Greene, PhD, points out,1 assisting families in understanding the gaps in skills that bring out opposition and categorizing behaviors into the rare “must-do’s,” and the many “just drop it’s,” in order to focus on understanding and building strategies and cooperation for situations that are important but not critical (Plan B) may require regular counseling by a mental health professional to help a child develop adaptive behavior and facilitate family harmony.

Reference

1. Greene RW. The Explosive Child: A New Approach for Understanding and Parenting Easily Frustrated, Chronically Inflexible Children, Sixth Edition, (New York: Harper Paperbacks, 2021).

Dr. Howard is assistant professor of pediatrics at Johns Hopkins University, Baltimore, and creator of CHADIS (www.CHADIS.com). She had no other relevant disclosures. Dr. Howard’s contribution to this publication was as a paid expert to MDedge News. Email her at [email protected].

Publications
Topics
Sections

The best plan for oppositional behavior in a school-aged child is prevention at younger ages! But here is the family coming to see us, struggling to get cooperation, and often increasingly embarrassed and angry.

Sometimes the dynamics leading to this behavior seem obvious: the parent tells their child to put away the toys they have pulled out in your waiting room, is ignored, and cleans them up themselves without a word. The child smugly fiddles with their cell phone, reinforced by removal of the task. Even without a defined reward, this still constitutes positive reinforcement as it increases the likelihood of the same future behavior of ignoring a parental directive.

Dr. Barbara J. Howard

Preventing this “mild” oppositionality at a younger age may come from the parent jollying the child through the clean up, participating with them in a game-like way counting the toys or making it a race, or even using only one request before grasping the child’s hand and “assisting” them in picking up a toy while praising cooperation but these tactics become less appropriate with age.

Other factors that may have led to school-aged child refusal include yelling at them, shaming, comparing them with a more compliant sibling, threatening a punishment that is never carried out, or deferring a consequence to the other caregiver. Of course, no child would want to please a caregiver with this kind of interaction by obeying them. By school age, children have a greater need to exert autonomy and avoid humiliation and may do this by getting angry, talking back, insulting the parent, or leaving the scene. This is especially likely if peers or siblings are present and the child wants to show that they can’t be bossed around.
 

Practical advice

So what can we advise when habits of refusal have already been established? Keeping in mind the major school-age psychosocial tasks of developing autonomy and self-esteem, the parent may need to overdo opportunities for this child to have choices and experience respect. When the child has a generalized oppositional stance, the parent may feel that it is difficult to identify opportunities to do this. The key in that case is to set up for cooperation and focus on small positive or neutral bits of behavior to reinforce. For example, requesting that the child do something they want to do anyways, such as come for a snack or turn on the TV, can be met with a brief but sincere “thanks” or “thanks for hopping on that.”

Sarcasm is counterproductive at all times, as it is insulting. Asking the child’s opinion regularly then listening and reflecting, rephrasing what they said, and even checking to see if the parent “got it right” do not require that the parent agrees. Any disagreement that the parent feels is needed can be withheld for a few minutes to indicate respect for the child’s opinion. For a child to learn to make “good choices” of behavior comes also from noticing how “not so good choices” worked out, a reflection the parent can try to elicit nonjudgmentally. Rebuilding the relationship can be done over time with respectful communication and assuring daily times of showing interest in the child, fooling around together, or playing a game.

While giving more choices respects autonomy, the options must really be acceptable to the parent. They may allow the child to choose some aspects of family activities – a skate park, or a certain eatery, or parts of the outing could be optional. Sometimes the order of upcoming events can provide a choice even if attendance is required. Sometimes the dress code can be flexible (flip flops, okay sure!), or a friend (preferably a well-behaved one!) could be invited along.
 

 

 

Pitfalls to avoid

Avoiding humiliation may be obvious, such as not complementing a singing performance or insistence on the child self-reporting bad behavior. For some families the parents may need to avoid their own embarrassing habits of “bad jokes” or outlandish clothes as a reasonable accommodation. Other kinds of humiliation to avoid may be specific to the child’s weaknesses, such as insisting that a clumsy child play on a team or a shy child speak to strangers. While it may be valuable for the child to work on those weaknesses, this should be done in private, if possible, or even with a coach who is not the parent if the relationship is strained.

Sensitive or anxious children are more prone to embarrassment and may then react with oppositional responses. They often do better with notice or coaching for upcoming events that may be in a category that has upset them in the past; for example, a visit from an overly affectionate aunt. Children may gain respect for their parents by being given a task that serves as an early escape route for these situations (Oh, would you please run out to the car and get my sweater?) although progressively tolerating undesirable situations is also important practice. A kindly debrief later with praise for progress also builds skills.
 

Reinforcing behaviors and revisiting consequences

Gaining more privileges as the reward for cooperation and responsibility is the natural sequence with development but oppositional children may need a chart, ideally negotiated as a family, to be clear about this cause-effect plan and what is expected for them to earn more freedom. Another benefit of a chart is that it is an objective translator of rules that can literally be pointed to rather than a parent-child conversation that could become an argument. Parents need to make expectations clear and follow through on promised increased privileges or consequences to be seen as fair. Having regular routines for chores, not just for activities, reduces refusal as well. Such concrete steps are especially important for children with ADHD who are often easily distracted from parental requests even if they meant to follow them and have a weak sense of timing. I have seen some wise parents give their distracted or impulsive child “a minute to decide if that is their final choice” before levying a consequence.

“When-then” statements can be useful both for coaching appropriate behavior in advance, debriefs, and alerting to consequences when needed. For example: “When you ask your aunt a question right away when you meet her then her hugs will be shorter” is coaching. “When you come home an hour late then you will have an hour earlier curfew the next week” is a graded consequence.
 

The cell phone issue

I can’t omit mentioning the specific situation of a child on a cell phone or tablet ignoring or refusing requests. While having possession of such a device may be seen as a safety measure (How can he reach me?) and social coinage (All my friends have one!), they are distracting and addicting and now the most common reason I see for oppositional interactions. This has been discussed elsewhere, so let me just say that a device is a privilege and should not “belong” to a child. Delaying the age of “lending” the device, establishing rules for use to certain situations and durations, and removing it for defined periods if it is interfering with cooperation are basic principles, even though enforcing them may result in upsets. Parents may need to change their own device use to be able to address oppositional behavior in their child.

 

 

Strategies for building better behavior

How important is it for the parent to verbalize what they are doing to instruct or accommodate their school-aged child? In the presence of others, the fewer words highlighting that an intervention is underway the better. Sometimes having a secret signal to prompt or praise, even a wink, can be helpful without being humiliating. These should be decided on together in private and practiced at first in nonstressful situations. Comments of appreciation or praise are appropriate then and are often reinforcing but should be very specific; for example, “I’m glad you got ready right away when it was time to leave” rather than general or backwards praise “Ready on time today, huh?” For some, especially younger or special-needs children, marks, points, tickets, tokens, or little prizes may be beneficial reinforcers, especially when trying to establish new patterns of interaction. Praise should fairly quickly replace more concrete rewards, though, by weaning, first by intermittent delivery or spacing further apart.

When counseling about oppositional behavior in school-aged children eliciting specific examples is key to determining whether parents are overly rigid or lax, have realistic expectations for their individual child’s temperament, skills, and past experiences (for example, traumas). As Ross Greene, PhD, points out,1 assisting families in understanding the gaps in skills that bring out opposition and categorizing behaviors into the rare “must-do’s,” and the many “just drop it’s,” in order to focus on understanding and building strategies and cooperation for situations that are important but not critical (Plan B) may require regular counseling by a mental health professional to help a child develop adaptive behavior and facilitate family harmony.

Reference

1. Greene RW. The Explosive Child: A New Approach for Understanding and Parenting Easily Frustrated, Chronically Inflexible Children, Sixth Edition, (New York: Harper Paperbacks, 2021).

Dr. Howard is assistant professor of pediatrics at Johns Hopkins University, Baltimore, and creator of CHADIS (www.CHADIS.com). She had no other relevant disclosures. Dr. Howard’s contribution to this publication was as a paid expert to MDedge News. Email her at [email protected].

The best plan for oppositional behavior in a school-aged child is prevention at younger ages! But here is the family coming to see us, struggling to get cooperation, and often increasingly embarrassed and angry.

Sometimes the dynamics leading to this behavior seem obvious: the parent tells their child to put away the toys they have pulled out in your waiting room, is ignored, and cleans them up themselves without a word. The child smugly fiddles with their cell phone, reinforced by removal of the task. Even without a defined reward, this still constitutes positive reinforcement as it increases the likelihood of the same future behavior of ignoring a parental directive.

Dr. Barbara J. Howard

Preventing this “mild” oppositionality at a younger age may come from the parent jollying the child through the clean up, participating with them in a game-like way counting the toys or making it a race, or even using only one request before grasping the child’s hand and “assisting” them in picking up a toy while praising cooperation but these tactics become less appropriate with age.

Other factors that may have led to school-aged child refusal include yelling at them, shaming, comparing them with a more compliant sibling, threatening a punishment that is never carried out, or deferring a consequence to the other caregiver. Of course, no child would want to please a caregiver with this kind of interaction by obeying them. By school age, children have a greater need to exert autonomy and avoid humiliation and may do this by getting angry, talking back, insulting the parent, or leaving the scene. This is especially likely if peers or siblings are present and the child wants to show that they can’t be bossed around.
 

Practical advice

So what can we advise when habits of refusal have already been established? Keeping in mind the major school-age psychosocial tasks of developing autonomy and self-esteem, the parent may need to overdo opportunities for this child to have choices and experience respect. When the child has a generalized oppositional stance, the parent may feel that it is difficult to identify opportunities to do this. The key in that case is to set up for cooperation and focus on small positive or neutral bits of behavior to reinforce. For example, requesting that the child do something they want to do anyways, such as come for a snack or turn on the TV, can be met with a brief but sincere “thanks” or “thanks for hopping on that.”

Sarcasm is counterproductive at all times, as it is insulting. Asking the child’s opinion regularly then listening and reflecting, rephrasing what they said, and even checking to see if the parent “got it right” do not require that the parent agrees. Any disagreement that the parent feels is needed can be withheld for a few minutes to indicate respect for the child’s opinion. For a child to learn to make “good choices” of behavior comes also from noticing how “not so good choices” worked out, a reflection the parent can try to elicit nonjudgmentally. Rebuilding the relationship can be done over time with respectful communication and assuring daily times of showing interest in the child, fooling around together, or playing a game.

While giving more choices respects autonomy, the options must really be acceptable to the parent. They may allow the child to choose some aspects of family activities – a skate park, or a certain eatery, or parts of the outing could be optional. Sometimes the order of upcoming events can provide a choice even if attendance is required. Sometimes the dress code can be flexible (flip flops, okay sure!), or a friend (preferably a well-behaved one!) could be invited along.
 

 

 

Pitfalls to avoid

Avoiding humiliation may be obvious, such as not complementing a singing performance or insistence on the child self-reporting bad behavior. For some families the parents may need to avoid their own embarrassing habits of “bad jokes” or outlandish clothes as a reasonable accommodation. Other kinds of humiliation to avoid may be specific to the child’s weaknesses, such as insisting that a clumsy child play on a team or a shy child speak to strangers. While it may be valuable for the child to work on those weaknesses, this should be done in private, if possible, or even with a coach who is not the parent if the relationship is strained.

Sensitive or anxious children are more prone to embarrassment and may then react with oppositional responses. They often do better with notice or coaching for upcoming events that may be in a category that has upset them in the past; for example, a visit from an overly affectionate aunt. Children may gain respect for their parents by being given a task that serves as an early escape route for these situations (Oh, would you please run out to the car and get my sweater?) although progressively tolerating undesirable situations is also important practice. A kindly debrief later with praise for progress also builds skills.
 

Reinforcing behaviors and revisiting consequences

Gaining more privileges as the reward for cooperation and responsibility is the natural sequence with development but oppositional children may need a chart, ideally negotiated as a family, to be clear about this cause-effect plan and what is expected for them to earn more freedom. Another benefit of a chart is that it is an objective translator of rules that can literally be pointed to rather than a parent-child conversation that could become an argument. Parents need to make expectations clear and follow through on promised increased privileges or consequences to be seen as fair. Having regular routines for chores, not just for activities, reduces refusal as well. Such concrete steps are especially important for children with ADHD who are often easily distracted from parental requests even if they meant to follow them and have a weak sense of timing. I have seen some wise parents give their distracted or impulsive child “a minute to decide if that is their final choice” before levying a consequence.

“When-then” statements can be useful both for coaching appropriate behavior in advance, debriefs, and alerting to consequences when needed. For example: “When you ask your aunt a question right away when you meet her then her hugs will be shorter” is coaching. “When you come home an hour late then you will have an hour earlier curfew the next week” is a graded consequence.
 

The cell phone issue

I can’t omit mentioning the specific situation of a child on a cell phone or tablet ignoring or refusing requests. While having possession of such a device may be seen as a safety measure (How can he reach me?) and social coinage (All my friends have one!), they are distracting and addicting and now the most common reason I see for oppositional interactions. This has been discussed elsewhere, so let me just say that a device is a privilege and should not “belong” to a child. Delaying the age of “lending” the device, establishing rules for use to certain situations and durations, and removing it for defined periods if it is interfering with cooperation are basic principles, even though enforcing them may result in upsets. Parents may need to change their own device use to be able to address oppositional behavior in their child.

 

 

Strategies for building better behavior

How important is it for the parent to verbalize what they are doing to instruct or accommodate their school-aged child? In the presence of others, the fewer words highlighting that an intervention is underway the better. Sometimes having a secret signal to prompt or praise, even a wink, can be helpful without being humiliating. These should be decided on together in private and practiced at first in nonstressful situations. Comments of appreciation or praise are appropriate then and are often reinforcing but should be very specific; for example, “I’m glad you got ready right away when it was time to leave” rather than general or backwards praise “Ready on time today, huh?” For some, especially younger or special-needs children, marks, points, tickets, tokens, or little prizes may be beneficial reinforcers, especially when trying to establish new patterns of interaction. Praise should fairly quickly replace more concrete rewards, though, by weaning, first by intermittent delivery or spacing further apart.

When counseling about oppositional behavior in school-aged children eliciting specific examples is key to determining whether parents are overly rigid or lax, have realistic expectations for their individual child’s temperament, skills, and past experiences (for example, traumas). As Ross Greene, PhD, points out,1 assisting families in understanding the gaps in skills that bring out opposition and categorizing behaviors into the rare “must-do’s,” and the many “just drop it’s,” in order to focus on understanding and building strategies and cooperation for situations that are important but not critical (Plan B) may require regular counseling by a mental health professional to help a child develop adaptive behavior and facilitate family harmony.

Reference

1. Greene RW. The Explosive Child: A New Approach for Understanding and Parenting Easily Frustrated, Chronically Inflexible Children, Sixth Edition, (New York: Harper Paperbacks, 2021).

Dr. Howard is assistant professor of pediatrics at Johns Hopkins University, Baltimore, and creator of CHADIS (www.CHADIS.com). She had no other relevant disclosures. Dr. Howard’s contribution to this publication was as a paid expert to MDedge News. Email her at [email protected].

Publications
Publications
Topics
Article Type
Sections
Disallow All Ads
Content Gating
No Gating (article Unlocked/Free)
Alternative CME
Disqus Comments
Default
Use ProPublica
Hide sidebar & use full width
render the right sidebar.
Conference Recap Checkbox
Not Conference Recap
Clinical Edge
Display the Slideshow in this Article
Medscape Article
Display survey writer
Reuters content
Disable Inline Native ads
WebMD Article

New COVID shots will be available in September

Article Type
Changed
Mon, 08/21/2023 - 12:18

The newest version of the COVID-19 vaccine will be available by the end of September, according to the Centers for Disease Control and Prevention. 

The updated vaccine still needs final sign-offs from the Food and Drug Administration and the CDC.

“We anticipate that they are going to be available for most folks by the third or fourth week of September,” Director Mandy Cohen, MD, MPH, said on a podcast hosted by former White House COVID adviser Andy Slavitt. “We are likely to see this as a recommendation as an annual COVID shot, just as we have an annual flu shot. I think that will give folks more clarity on whether they should get one or not.”

For people who are considering now whether they should get the currently available COVID vaccine or wait until the new one comes out, Dr. Cohen said that depends on a person’s individual risk. People who are 65 or older or who have multiple health conditions should go ahead and get the currently available shot if it’s been more than 6-8 months since their last dose. For all other people, it’s OK to wait for the new version.

Analysts expect low demand for the updated vaccine. About 240 million people in the United States got at least one dose when vaccines first became available in 2021, Reuters reported, but that number dropped to less than 50 million getting the most updated shot in the fall of 2022.

“Take a look at what happened last winter. It was 50 million in the U.S., and it seems likely to be lower than that, given that there’s less concern about COVID this year than last year,” Michael Yee, a health care industry analyst for the firm Jefferies, told Reuters.

Dr. Cohen noted during the podcast that the recent uptick in virus activity should be taken in context. 

“What we’re seeing right now in August of 2023 are small increases of folks getting COVID. We are still at some of the lowest hospitalizations that we’ve been at in the past 3 years,” she said. “Even a 10% increase on a very, very small number is still very small. My level of concern continues to be low.”

A version of this article was first published on WebMD.com .

Publications
Topics
Sections

The newest version of the COVID-19 vaccine will be available by the end of September, according to the Centers for Disease Control and Prevention. 

The updated vaccine still needs final sign-offs from the Food and Drug Administration and the CDC.

“We anticipate that they are going to be available for most folks by the third or fourth week of September,” Director Mandy Cohen, MD, MPH, said on a podcast hosted by former White House COVID adviser Andy Slavitt. “We are likely to see this as a recommendation as an annual COVID shot, just as we have an annual flu shot. I think that will give folks more clarity on whether they should get one or not.”

For people who are considering now whether they should get the currently available COVID vaccine or wait until the new one comes out, Dr. Cohen said that depends on a person’s individual risk. People who are 65 or older or who have multiple health conditions should go ahead and get the currently available shot if it’s been more than 6-8 months since their last dose. For all other people, it’s OK to wait for the new version.

Analysts expect low demand for the updated vaccine. About 240 million people in the United States got at least one dose when vaccines first became available in 2021, Reuters reported, but that number dropped to less than 50 million getting the most updated shot in the fall of 2022.

“Take a look at what happened last winter. It was 50 million in the U.S., and it seems likely to be lower than that, given that there’s less concern about COVID this year than last year,” Michael Yee, a health care industry analyst for the firm Jefferies, told Reuters.

Dr. Cohen noted during the podcast that the recent uptick in virus activity should be taken in context. 

“What we’re seeing right now in August of 2023 are small increases of folks getting COVID. We are still at some of the lowest hospitalizations that we’ve been at in the past 3 years,” she said. “Even a 10% increase on a very, very small number is still very small. My level of concern continues to be low.”

A version of this article was first published on WebMD.com .

The newest version of the COVID-19 vaccine will be available by the end of September, according to the Centers for Disease Control and Prevention. 

The updated vaccine still needs final sign-offs from the Food and Drug Administration and the CDC.

“We anticipate that they are going to be available for most folks by the third or fourth week of September,” Director Mandy Cohen, MD, MPH, said on a podcast hosted by former White House COVID adviser Andy Slavitt. “We are likely to see this as a recommendation as an annual COVID shot, just as we have an annual flu shot. I think that will give folks more clarity on whether they should get one or not.”

For people who are considering now whether they should get the currently available COVID vaccine or wait until the new one comes out, Dr. Cohen said that depends on a person’s individual risk. People who are 65 or older or who have multiple health conditions should go ahead and get the currently available shot if it’s been more than 6-8 months since their last dose. For all other people, it’s OK to wait for the new version.

Analysts expect low demand for the updated vaccine. About 240 million people in the United States got at least one dose when vaccines first became available in 2021, Reuters reported, but that number dropped to less than 50 million getting the most updated shot in the fall of 2022.

“Take a look at what happened last winter. It was 50 million in the U.S., and it seems likely to be lower than that, given that there’s less concern about COVID this year than last year,” Michael Yee, a health care industry analyst for the firm Jefferies, told Reuters.

Dr. Cohen noted during the podcast that the recent uptick in virus activity should be taken in context. 

“What we’re seeing right now in August of 2023 are small increases of folks getting COVID. We are still at some of the lowest hospitalizations that we’ve been at in the past 3 years,” she said. “Even a 10% increase on a very, very small number is still very small. My level of concern continues to be low.”

A version of this article was first published on WebMD.com .

Publications
Publications
Topics
Article Type
Sections
Disallow All Ads
Content Gating
No Gating (article Unlocked/Free)
Alternative CME
Disqus Comments
Default
Use ProPublica
Hide sidebar & use full width
render the right sidebar.
Conference Recap Checkbox
Not Conference Recap
Clinical Edge
Display the Slideshow in this Article
Medscape Article
Display survey writer
Reuters content
Disable Inline Native ads
WebMD Article

Crohn’s link seen for ultraprocessed foods

Article Type
Changed
Tue, 08/15/2023 - 09:16

High consumption of ultraprocessed foods increases the risk of developing Crohn’s disease, according to results from a large meta-analysis, but not ulcerative colitis.

Ultraprocessed foods contain large amounts of artificial flavors, stabilizers, emulsifiers, sweeteners, or preservatives. Studies have linked higher consumption of them to cardiovascular disease, diabetes, obesity, and cancers.

For their research, published in Clinical Gastroenterology and Hepatology, Neeraj Nerula, MD of McMaster University, Hamilton, Ont., and colleagues pooled data from five recent cohort studies to assess whether their consumption was also linked to inflammatory bowel disease.

The included cohort studies together enrolled more than 1 million participants (mean age, 43-56; 55%-85% female). Of these, 916 developed Crohn’s disease, and 1,934 developed ulcerative colitis, during follow-up. None of the participants had IBD at baseline, and all were followed up at least 1 year. All the studies used the same food classification system, called NOVA, to assess foods eaten, and all were conducted between 2020 and 2022.

People who consumed more ultraprocessed foods saw higher Crohn’s risk, compared with those classed as consuming lower amounts of these foods (hazard ratio, 1.71; 95% confidence interval, 1.37-2.14). Also, lower risk of Crohn’s was observed among participants who consumed more unprocessed or minimally processed foods, such as vegetables, chicken, milk, and eggs (HR, 0.71; 95% CI, 0.53-0.94). The same associations were not seen for ulcerative colitis.

“Our findings support the hypothesis that consumption of [ultraprocessed foods] and low consumption of unprocessed/minimally processed foods may increase the risk for CD,” Dr. Nerula and colleagues wrote. The lack of association seen with ulcerative colitis might be explained by differences in the pathogenesis of each disease.

Ultraprocessed foods might contribute to Crohn’s by disrupting gut microbiota, the authors wrote. “For instance, emulsifiers have been shown to increase epithelial permeability, disruption of the intestinal barrier, and gut dysbiosis in mice. Carboxymethyl cellulose has been shown to facilitate bacterial adherence to gut epithelium, possibly leading to bacterial overgrowth and invasion of bacteria in between the intestinal villi. Furthermore, additives such as carrageenan, titanium dioxide, and maltodextrin have been shown to promote intestinal inflammation.”

Dr. Nerula and colleagues described as strengths of their study its large size, the low heterogenicity of the included studies, and the use of validated, standardized questionnaires to measure dietary intake in each study. Nonetheless, they cautioned, the results might not apply to younger age groups, and the majority of participants were White North Americans and Europeans, making it difficult to generalize results.

“Advancements in food processing and associated changes in dietary patterns could explain the rise of IBD incidence during the 20th and 21st centuries,” Dr. Narula and colleagues concluded. “Further investigations are needed to identify the specific potential culprits among processed foods that could account for the increased risk of CD observed.”

The study authors did not report outside funding. Dr. Narula disclosed receiving fees from pharmaceutical manufacturers including Janssen, AbbVie, Takeda, Pfizer, Merck, and others. Two of coauthors also disclosed receiving funds from industry, and five additional coauthors had no conflicts.

Body

 

The causes of inflammatory bowel disease (IBD) are thought to be multifactorial and include genetic predisposition, dysregulated immune responses, imbalances in the intestinal microbiota, and environmental exposures.

Incidence and prevalence of IBD has increased over time, including in developing countries, and appear to parallel industrialization and “Westernization” of societies. One of the potential contributors to IBD risk is diet. Dietary changes associated with more modern or “Westernized” diets, including increases in processed foods, are some of the factors hypothesized to contribute to rising rates of IBD.

courtesy Mount Sinai Health System
Dr. Ryan Ungaro
There is accumulating data that certain diets, such as the Mediterranean diet, may have beneficial effects in established Crohn’s disease (CD) and ulcerative colitis (UC).

In the meta-analysis by Narula and colleagues, the authors observed a significant increase in the risk of CD, but not UC, in individuals who consumed significantly higher amounts of ultraprocessed foods (that is, frozen or long-shelf-life foods, products with thickeners/emulsifiers, etc.). Although there are limitations to the studies included in the meta-analysis, the association is intriguing and could point to potential lifestyle modifications that could form the basis of preventative interventions for individuals at higher risk for IBD, such as first-degree relatives.

More immediately, prospective research is needed to understand if restricting ultraprocessed foods (or increasing less-processed foods) can decrease disease activity or prevent flares in patients with IBD.

Understanding factors that predispose to or trigger IBD, such as specific dietary components, will lead to improved management strategies and ultimately preventative interventions.

Ryan Ungaro, MD, MS, is an associate professor of medicine in the division of gastroenterology at the Icahn School of Medicine at Mount Sinai, New York. He is director of the Comprehensive Care for the Recently Diagnosed IBD Patient (COMPASS-IBD). He has served as an advisory board member or consultant for AbbVie, Bristol-Myers Squibb, Celltrion, Lilly, Janssen, Pfizer, Roivant, and Takeda, and has received research support from AbbVie, Boehringer Ingelheim, Bristol-Myers Squibb, Lily, and Pfizer.

Publications
Topics
Sections
Body

 

The causes of inflammatory bowel disease (IBD) are thought to be multifactorial and include genetic predisposition, dysregulated immune responses, imbalances in the intestinal microbiota, and environmental exposures.

Incidence and prevalence of IBD has increased over time, including in developing countries, and appear to parallel industrialization and “Westernization” of societies. One of the potential contributors to IBD risk is diet. Dietary changes associated with more modern or “Westernized” diets, including increases in processed foods, are some of the factors hypothesized to contribute to rising rates of IBD.

courtesy Mount Sinai Health System
Dr. Ryan Ungaro
There is accumulating data that certain diets, such as the Mediterranean diet, may have beneficial effects in established Crohn’s disease (CD) and ulcerative colitis (UC).

In the meta-analysis by Narula and colleagues, the authors observed a significant increase in the risk of CD, but not UC, in individuals who consumed significantly higher amounts of ultraprocessed foods (that is, frozen or long-shelf-life foods, products with thickeners/emulsifiers, etc.). Although there are limitations to the studies included in the meta-analysis, the association is intriguing and could point to potential lifestyle modifications that could form the basis of preventative interventions for individuals at higher risk for IBD, such as first-degree relatives.

More immediately, prospective research is needed to understand if restricting ultraprocessed foods (or increasing less-processed foods) can decrease disease activity or prevent flares in patients with IBD.

Understanding factors that predispose to or trigger IBD, such as specific dietary components, will lead to improved management strategies and ultimately preventative interventions.

Ryan Ungaro, MD, MS, is an associate professor of medicine in the division of gastroenterology at the Icahn School of Medicine at Mount Sinai, New York. He is director of the Comprehensive Care for the Recently Diagnosed IBD Patient (COMPASS-IBD). He has served as an advisory board member or consultant for AbbVie, Bristol-Myers Squibb, Celltrion, Lilly, Janssen, Pfizer, Roivant, and Takeda, and has received research support from AbbVie, Boehringer Ingelheim, Bristol-Myers Squibb, Lily, and Pfizer.

Body

 

The causes of inflammatory bowel disease (IBD) are thought to be multifactorial and include genetic predisposition, dysregulated immune responses, imbalances in the intestinal microbiota, and environmental exposures.

Incidence and prevalence of IBD has increased over time, including in developing countries, and appear to parallel industrialization and “Westernization” of societies. One of the potential contributors to IBD risk is diet. Dietary changes associated with more modern or “Westernized” diets, including increases in processed foods, are some of the factors hypothesized to contribute to rising rates of IBD.

courtesy Mount Sinai Health System
Dr. Ryan Ungaro
There is accumulating data that certain diets, such as the Mediterranean diet, may have beneficial effects in established Crohn’s disease (CD) and ulcerative colitis (UC).

In the meta-analysis by Narula and colleagues, the authors observed a significant increase in the risk of CD, but not UC, in individuals who consumed significantly higher amounts of ultraprocessed foods (that is, frozen or long-shelf-life foods, products with thickeners/emulsifiers, etc.). Although there are limitations to the studies included in the meta-analysis, the association is intriguing and could point to potential lifestyle modifications that could form the basis of preventative interventions for individuals at higher risk for IBD, such as first-degree relatives.

More immediately, prospective research is needed to understand if restricting ultraprocessed foods (or increasing less-processed foods) can decrease disease activity or prevent flares in patients with IBD.

Understanding factors that predispose to or trigger IBD, such as specific dietary components, will lead to improved management strategies and ultimately preventative interventions.

Ryan Ungaro, MD, MS, is an associate professor of medicine in the division of gastroenterology at the Icahn School of Medicine at Mount Sinai, New York. He is director of the Comprehensive Care for the Recently Diagnosed IBD Patient (COMPASS-IBD). He has served as an advisory board member or consultant for AbbVie, Bristol-Myers Squibb, Celltrion, Lilly, Janssen, Pfizer, Roivant, and Takeda, and has received research support from AbbVie, Boehringer Ingelheim, Bristol-Myers Squibb, Lily, and Pfizer.

High consumption of ultraprocessed foods increases the risk of developing Crohn’s disease, according to results from a large meta-analysis, but not ulcerative colitis.

Ultraprocessed foods contain large amounts of artificial flavors, stabilizers, emulsifiers, sweeteners, or preservatives. Studies have linked higher consumption of them to cardiovascular disease, diabetes, obesity, and cancers.

For their research, published in Clinical Gastroenterology and Hepatology, Neeraj Nerula, MD of McMaster University, Hamilton, Ont., and colleagues pooled data from five recent cohort studies to assess whether their consumption was also linked to inflammatory bowel disease.

The included cohort studies together enrolled more than 1 million participants (mean age, 43-56; 55%-85% female). Of these, 916 developed Crohn’s disease, and 1,934 developed ulcerative colitis, during follow-up. None of the participants had IBD at baseline, and all were followed up at least 1 year. All the studies used the same food classification system, called NOVA, to assess foods eaten, and all were conducted between 2020 and 2022.

People who consumed more ultraprocessed foods saw higher Crohn’s risk, compared with those classed as consuming lower amounts of these foods (hazard ratio, 1.71; 95% confidence interval, 1.37-2.14). Also, lower risk of Crohn’s was observed among participants who consumed more unprocessed or minimally processed foods, such as vegetables, chicken, milk, and eggs (HR, 0.71; 95% CI, 0.53-0.94). The same associations were not seen for ulcerative colitis.

“Our findings support the hypothesis that consumption of [ultraprocessed foods] and low consumption of unprocessed/minimally processed foods may increase the risk for CD,” Dr. Nerula and colleagues wrote. The lack of association seen with ulcerative colitis might be explained by differences in the pathogenesis of each disease.

Ultraprocessed foods might contribute to Crohn’s by disrupting gut microbiota, the authors wrote. “For instance, emulsifiers have been shown to increase epithelial permeability, disruption of the intestinal barrier, and gut dysbiosis in mice. Carboxymethyl cellulose has been shown to facilitate bacterial adherence to gut epithelium, possibly leading to bacterial overgrowth and invasion of bacteria in between the intestinal villi. Furthermore, additives such as carrageenan, titanium dioxide, and maltodextrin have been shown to promote intestinal inflammation.”

Dr. Nerula and colleagues described as strengths of their study its large size, the low heterogenicity of the included studies, and the use of validated, standardized questionnaires to measure dietary intake in each study. Nonetheless, they cautioned, the results might not apply to younger age groups, and the majority of participants were White North Americans and Europeans, making it difficult to generalize results.

“Advancements in food processing and associated changes in dietary patterns could explain the rise of IBD incidence during the 20th and 21st centuries,” Dr. Narula and colleagues concluded. “Further investigations are needed to identify the specific potential culprits among processed foods that could account for the increased risk of CD observed.”

The study authors did not report outside funding. Dr. Narula disclosed receiving fees from pharmaceutical manufacturers including Janssen, AbbVie, Takeda, Pfizer, Merck, and others. Two of coauthors also disclosed receiving funds from industry, and five additional coauthors had no conflicts.

High consumption of ultraprocessed foods increases the risk of developing Crohn’s disease, according to results from a large meta-analysis, but not ulcerative colitis.

Ultraprocessed foods contain large amounts of artificial flavors, stabilizers, emulsifiers, sweeteners, or preservatives. Studies have linked higher consumption of them to cardiovascular disease, diabetes, obesity, and cancers.

For their research, published in Clinical Gastroenterology and Hepatology, Neeraj Nerula, MD of McMaster University, Hamilton, Ont., and colleagues pooled data from five recent cohort studies to assess whether their consumption was also linked to inflammatory bowel disease.

The included cohort studies together enrolled more than 1 million participants (mean age, 43-56; 55%-85% female). Of these, 916 developed Crohn’s disease, and 1,934 developed ulcerative colitis, during follow-up. None of the participants had IBD at baseline, and all were followed up at least 1 year. All the studies used the same food classification system, called NOVA, to assess foods eaten, and all were conducted between 2020 and 2022.

People who consumed more ultraprocessed foods saw higher Crohn’s risk, compared with those classed as consuming lower amounts of these foods (hazard ratio, 1.71; 95% confidence interval, 1.37-2.14). Also, lower risk of Crohn’s was observed among participants who consumed more unprocessed or minimally processed foods, such as vegetables, chicken, milk, and eggs (HR, 0.71; 95% CI, 0.53-0.94). The same associations were not seen for ulcerative colitis.

“Our findings support the hypothesis that consumption of [ultraprocessed foods] and low consumption of unprocessed/minimally processed foods may increase the risk for CD,” Dr. Nerula and colleagues wrote. The lack of association seen with ulcerative colitis might be explained by differences in the pathogenesis of each disease.

Ultraprocessed foods might contribute to Crohn’s by disrupting gut microbiota, the authors wrote. “For instance, emulsifiers have been shown to increase epithelial permeability, disruption of the intestinal barrier, and gut dysbiosis in mice. Carboxymethyl cellulose has been shown to facilitate bacterial adherence to gut epithelium, possibly leading to bacterial overgrowth and invasion of bacteria in between the intestinal villi. Furthermore, additives such as carrageenan, titanium dioxide, and maltodextrin have been shown to promote intestinal inflammation.”

Dr. Nerula and colleagues described as strengths of their study its large size, the low heterogenicity of the included studies, and the use of validated, standardized questionnaires to measure dietary intake in each study. Nonetheless, they cautioned, the results might not apply to younger age groups, and the majority of participants were White North Americans and Europeans, making it difficult to generalize results.

“Advancements in food processing and associated changes in dietary patterns could explain the rise of IBD incidence during the 20th and 21st centuries,” Dr. Narula and colleagues concluded. “Further investigations are needed to identify the specific potential culprits among processed foods that could account for the increased risk of CD observed.”

The study authors did not report outside funding. Dr. Narula disclosed receiving fees from pharmaceutical manufacturers including Janssen, AbbVie, Takeda, Pfizer, Merck, and others. Two of coauthors also disclosed receiving funds from industry, and five additional coauthors had no conflicts.

Publications
Publications
Topics
Article Type
Sections
Article Source

FROM CLINICAL GASTROENTEROLOGY AND HEPATOLOGY

Disallow All Ads
Content Gating
No Gating (article Unlocked/Free)
Alternative CME
Disqus Comments
Default
Use ProPublica
Hide sidebar & use full width
render the right sidebar.
Conference Recap Checkbox
Not Conference Recap
Clinical Edge
Display the Slideshow in this Article
Medscape Article
Display survey writer
Reuters content
Disable Inline Native ads
WebMD Article

FDA approves elranatamab for multiple myeloma

Article Type
Changed
Fri, 09/01/2023 - 17:14

The Food and Drug Administration has granted accelerated approval to the off-the-shelf biologic agent elranatamab (Elrexfio) for the treatment of relapsed or refractory multiple myeloma.

The B-cell maturation antigen (BCMA) CD3-targeted bispecific antibody (BsAb) was given Priority Review in February and had previously received Breakthrough Therapy Designation for relapsed or refractory multiple myeloma (RRMM), according to Pfizer.

Olivier Le Moal/Getty Images

FDA approval was based on favorable response and duration of response rates in the single-arm, phase 2 MagnetisMM-3 trial. The trial showed meaningful responses in heavily pretreated patients with RRMM who received elranatamab as their first BCMA-directed therapy.

The overall response rate in 97 BCMA-naive patients (cohort A) who previously received at least four lines of therapy, including a proteasome inhibitor, an immunomodulatory agent, and an anti-CD38 monoclonal antibody, was 58%, with an estimated 82% maintaining the response for 9 months or longer. Median time to first response was 1.2 months.

In 63 patients who received at least four prior lines of therapy, which also included a BCMA-directed therapy, the overall response rate was 33% after median follow-up of 10.2 months. An estimated 84% maintained a response for at least 9 months.

Elranatamab was given subcutaneously at a dose of 76 mg weekly on a 28-day cycle with a step-up priming dose regimen. The priming regimen included 12 mg and 32 mg doses on days 1 and 4, respectively, during cycle 1. Patients who received at least six cycles and showed at least a partial response for 2 or more months had a biweekly dosing interval.

Elranatamab carries a boxed warning for cytokine release syndrome (CRS) and neurologic toxicity, as well as warnings and precautions for infections, neutropenia, hepatotoxicity, and embryo–fetal toxicity. Therefore, the agent is available only through a restricted Risk Evaluation and Mitigation Strategy (REMS).

The boxed warning is included in the full prescribing information.

A confirmatory trial to gather additional safety and efficacy data was launched in 2022. Continued FDA approval is contingent on confirmed safety and efficacy data.

A version of this article first appeared on Medscape.com.

Publications
Topics
Sections

The Food and Drug Administration has granted accelerated approval to the off-the-shelf biologic agent elranatamab (Elrexfio) for the treatment of relapsed or refractory multiple myeloma.

The B-cell maturation antigen (BCMA) CD3-targeted bispecific antibody (BsAb) was given Priority Review in February and had previously received Breakthrough Therapy Designation for relapsed or refractory multiple myeloma (RRMM), according to Pfizer.

Olivier Le Moal/Getty Images

FDA approval was based on favorable response and duration of response rates in the single-arm, phase 2 MagnetisMM-3 trial. The trial showed meaningful responses in heavily pretreated patients with RRMM who received elranatamab as their first BCMA-directed therapy.

The overall response rate in 97 BCMA-naive patients (cohort A) who previously received at least four lines of therapy, including a proteasome inhibitor, an immunomodulatory agent, and an anti-CD38 monoclonal antibody, was 58%, with an estimated 82% maintaining the response for 9 months or longer. Median time to first response was 1.2 months.

In 63 patients who received at least four prior lines of therapy, which also included a BCMA-directed therapy, the overall response rate was 33% after median follow-up of 10.2 months. An estimated 84% maintained a response for at least 9 months.

Elranatamab was given subcutaneously at a dose of 76 mg weekly on a 28-day cycle with a step-up priming dose regimen. The priming regimen included 12 mg and 32 mg doses on days 1 and 4, respectively, during cycle 1. Patients who received at least six cycles and showed at least a partial response for 2 or more months had a biweekly dosing interval.

Elranatamab carries a boxed warning for cytokine release syndrome (CRS) and neurologic toxicity, as well as warnings and precautions for infections, neutropenia, hepatotoxicity, and embryo–fetal toxicity. Therefore, the agent is available only through a restricted Risk Evaluation and Mitigation Strategy (REMS).

The boxed warning is included in the full prescribing information.

A confirmatory trial to gather additional safety and efficacy data was launched in 2022. Continued FDA approval is contingent on confirmed safety and efficacy data.

A version of this article first appeared on Medscape.com.

The Food and Drug Administration has granted accelerated approval to the off-the-shelf biologic agent elranatamab (Elrexfio) for the treatment of relapsed or refractory multiple myeloma.

The B-cell maturation antigen (BCMA) CD3-targeted bispecific antibody (BsAb) was given Priority Review in February and had previously received Breakthrough Therapy Designation for relapsed or refractory multiple myeloma (RRMM), according to Pfizer.

Olivier Le Moal/Getty Images

FDA approval was based on favorable response and duration of response rates in the single-arm, phase 2 MagnetisMM-3 trial. The trial showed meaningful responses in heavily pretreated patients with RRMM who received elranatamab as their first BCMA-directed therapy.

The overall response rate in 97 BCMA-naive patients (cohort A) who previously received at least four lines of therapy, including a proteasome inhibitor, an immunomodulatory agent, and an anti-CD38 monoclonal antibody, was 58%, with an estimated 82% maintaining the response for 9 months or longer. Median time to first response was 1.2 months.

In 63 patients who received at least four prior lines of therapy, which also included a BCMA-directed therapy, the overall response rate was 33% after median follow-up of 10.2 months. An estimated 84% maintained a response for at least 9 months.

Elranatamab was given subcutaneously at a dose of 76 mg weekly on a 28-day cycle with a step-up priming dose regimen. The priming regimen included 12 mg and 32 mg doses on days 1 and 4, respectively, during cycle 1. Patients who received at least six cycles and showed at least a partial response for 2 or more months had a biweekly dosing interval.

Elranatamab carries a boxed warning for cytokine release syndrome (CRS) and neurologic toxicity, as well as warnings and precautions for infections, neutropenia, hepatotoxicity, and embryo–fetal toxicity. Therefore, the agent is available only through a restricted Risk Evaluation and Mitigation Strategy (REMS).

The boxed warning is included in the full prescribing information.

A confirmatory trial to gather additional safety and efficacy data was launched in 2022. Continued FDA approval is contingent on confirmed safety and efficacy data.

A version of this article first appeared on Medscape.com.

Publications
Publications
Topics
Article Type
Sections
Disallow All Ads
Content Gating
No Gating (article Unlocked/Free)
Alternative CME
Disqus Comments
Default
Use ProPublica
Hide sidebar & use full width
render the right sidebar.
Conference Recap Checkbox
Not Conference Recap
Clinical Edge
Display the Slideshow in this Article
Medscape Article
Display survey writer
Reuters content
Disable Inline Native ads
WebMD Article

Advancements help guide achalasia management, experts say

Article Type
Changed
Wed, 08/23/2023 - 13:39

Advancements in tools for assessing the function of the esophagus have led to important refinements in the diagnosis of achalasia and achalasia-like conditions, at a pace that has left the line-tracing technology considered to have debatable merit just 15 years ago “now as obsolete as a typewriter,” experts said recently in a review in Gastro Hep Advances.

“We have come to conceptualize esophageal motility disorders by specific aspects of physiological dysfunction,” wrote a trio of experts – Peter Kahrilas, MD, professor of medicine; Dustin Carlson, MD, MS, assistant professor of medicine, and John Pandolfino, MD, chief of gastroenterology and hepatology, all at Northwestern University, Chicago. “A major implication of this approach is a shift in management strategy toward rendering treatment in a phenotype-specific manner.”

High-resolution manometry (HRM) was trail-blazing, they said, as it replaced line-tracing manometry in evaluating the motility of the esophagus. HRM led to the subtyping of achalasia based on the three patterns of pressurization in the esophagus that are associated with obstruction at the esophagogastric junction. But the field has continued to advance.

“It has since become clear that obstructive physiology also occurs in syndromes besides achalasia involving the esophagogastric junction and/or distal esophagus,” Dr. Kahrilas, Dr. Carlson, and Dr. Pandolfino said. “In fact, obstructive physiology is increasingly recognized as the fundamental abnormality leading to the perception of dysphagia with esophageal motility disorders. This concept of obstructive physiology as the fundamental abnormality has substantially morphed the clinical management of esophageal motility disorders.”

HRM, has many limitations, but in cases of an uncertain achalasia diagnosis, functional luminal imaging probe (FLIP) technology can help, they said. FLIP can also help surgeons tailor myotomy procedures.

In FLIP, a probe is carefully filled with fluid, causing distension of the esophagus. In the test, the distensibility of the esophagogastric junction is measured. The procedure allows a more refined assessment of the movement of the esophagus, and the subtypes of achalasia.

Identifying the achalasia subtype is crucial to choosing the right treatment, data suggests. There have been no randomized controlled trials on achalasia management that prospectively consider achalasia subtype, but retrospective analysis of RCT data “suggests that achalasia subtypes are of great relevance in forecasting treatment effectiveness,” they said.

In one trial, pneumatic dilation was effective in 100% of type II achalasia, which involves panesophageal pressurization, significantly better than laparoscopic Heller myotomy (LHM). But it was much less effective than LHM in type III achalasia, the spastic form, although a significance couldn’t be established because of the number of cases. Data from a meta-analysis showed that peroral endoscopic myotomy, which allows for a longer myotomy if needed, was better than LHM for classic achalasia and spastic achalasia and was most efficacious overall.

The writers said that the diagnostic classifications for achalasia are likely to continue to evolve, pointing to the dynamic nature of the Chicago Classification for the disorder.

“The fact that it has now gone through four iterations since 2008 emphasizes that this is a work in progress and that no classification scheme of esophageal motility disorders based on a single test will ever be perfect,” they said. “After all, there are no biomarkers of esophageal motility disorders and, in the absence of a biomarker, there can be no ‘gold standard’ for diagnosis.”

Dr. Pandolfino, Dr. Kahrilas, and Northwestern University hold shared intellectual property rights and ownership surrounding FLIP Panometry systems, methods, and apparatus with Medtronic. Dr. Kahrilas reported consulting with Ironwood, Reckitt, and Phathom. Dr. Carlson reported conflicts of interest with Medtronic and Phathom Pharmaceuticals. Dr. Pandolfino reported conflicts of interest with Sandhill Scientific/Diversatek, Takeda, AstraZeneca, Medtronic, Torax, and Ironwood.

Body

 

16% of the U.S. population experience dysphagia, only half of whom seek medical care and the others manage their symptoms by modifying diet.

X-ray barium swallow and endoscopy with biopsy to exclude eosinophilic esophagitis are the initial tests for dysphagia diagnosis. If the above are normal, a high-resolution esophageal manometry impedance (HRMZ) is recommended to diagnose primary and secondary esophageal motility disorder.

Dr. Ravinder Mittal
Studies before and after the advent of HRM show that the primary esophageal motility disorders such as achalasia, diffuse esophageal spasm, and nutcracker esophagus/jackhammer esophagus when combined together, are seen in only about 20% of patients presenting with dysphagia symptom. Esophagogastric junction outflow obstruction (EGJOO), another primary esophageal motility disorder characterized by impaired lower esophageal sphincter relaxation (integrated relaxation pressure > 15) in the presence of normal peristalsis is seen in 5%-24% of patients with dysphagia.

However, only in a minority of patients is it likely to cause dysphagia because uncontrolled studies show that therapeutic strategies to address EGJOO (botox, dilation, and myotomy) relieve dysphagia symptoms in a minority of patients. Hence, in significant number of patients the cause of dysphagia symptoms remains obscure. It might be that our testing is inadequate, or possibly, patients have functional dysphagia (sensory dysfunction of the esophagus). My opinion is that it is the former.

The esophagus has only one simple function, that is, to transfer the pharyngeal pump driven, that is, swallowed contents to the stomach, for which its luminal cross-sectional area must be larger than that of the swallowed bolus and contraction (measured by manometry) behind the bolus must be of adequate strength. The latter is likely less relevant because humans eat in the upright position and gravity provides propulsion for the bolus. Stated simply, as long as esophagus can distend well and there is no resistance to the outflow at the EGJ, esophagus can achieve its goal. However, until recently, there was no single test to determine the distension and contraction, the two essential elements of primary esophageal peristalsis.

Endoscopy and x-ray barium swallow are tests to determine the luminal diameter but have limitations. Endoflip measures the opening function of the EGJ and is useful when the HRM is normal. However, pressures that are currently being used to measure the EGJ distensibility by Endoflip are not physiological. Furthermore, esophageal body motor function assessed by a bag that distends a long segment of the esophagus under high pressure is unphysiological. The distension-contraction plots, which determines the luminal CSA and contraction simultaneously during primary peristalsis is ideally suited to study the pathophysiology of esophageal motility disorders. Several studies from my laboratory show that in patients with nutcracker esophagus, EGJOO and normal HRM, the esophagus distends significantly less than that of normal subjects during primary peristalsis. I suspect that an esophageal contraction pushing bolus through a narrow lumen esophagus is the cause of dysphagia sensation in many patients that have been labeled as functional dysphagia.

The last 2 decades have seen significant progress in the diagnosis of esophageal motility disorders using HRM, Endoflip, and distension-contraction plots of peristalsis. Furthermore, endoscopic treatment of achalasia and “achalasia-like syndromes” is revolutionary. What is desperately needed is an understanding of the pathogenesis of esophageal motor disorders, pharmacotherapy of esophageal symptoms, such as chest pain, proton pump inhibitor–resistant heartburn, and others because dysfunctional esophagus is a huge burden on health care expenditures worldwide.

Ravinder K. Mittal, MD, is a professor of medicine and gastroenterologist with UC San Diego Health. He has patent application pending on the computer software Dplots.

Publications
Topics
Sections
Body

 

16% of the U.S. population experience dysphagia, only half of whom seek medical care and the others manage their symptoms by modifying diet.

X-ray barium swallow and endoscopy with biopsy to exclude eosinophilic esophagitis are the initial tests for dysphagia diagnosis. If the above are normal, a high-resolution esophageal manometry impedance (HRMZ) is recommended to diagnose primary and secondary esophageal motility disorder.

Dr. Ravinder Mittal
Studies before and after the advent of HRM show that the primary esophageal motility disorders such as achalasia, diffuse esophageal spasm, and nutcracker esophagus/jackhammer esophagus when combined together, are seen in only about 20% of patients presenting with dysphagia symptom. Esophagogastric junction outflow obstruction (EGJOO), another primary esophageal motility disorder characterized by impaired lower esophageal sphincter relaxation (integrated relaxation pressure > 15) in the presence of normal peristalsis is seen in 5%-24% of patients with dysphagia.

However, only in a minority of patients is it likely to cause dysphagia because uncontrolled studies show that therapeutic strategies to address EGJOO (botox, dilation, and myotomy) relieve dysphagia symptoms in a minority of patients. Hence, in significant number of patients the cause of dysphagia symptoms remains obscure. It might be that our testing is inadequate, or possibly, patients have functional dysphagia (sensory dysfunction of the esophagus). My opinion is that it is the former.

The esophagus has only one simple function, that is, to transfer the pharyngeal pump driven, that is, swallowed contents to the stomach, for which its luminal cross-sectional area must be larger than that of the swallowed bolus and contraction (measured by manometry) behind the bolus must be of adequate strength. The latter is likely less relevant because humans eat in the upright position and gravity provides propulsion for the bolus. Stated simply, as long as esophagus can distend well and there is no resistance to the outflow at the EGJ, esophagus can achieve its goal. However, until recently, there was no single test to determine the distension and contraction, the two essential elements of primary esophageal peristalsis.

Endoscopy and x-ray barium swallow are tests to determine the luminal diameter but have limitations. Endoflip measures the opening function of the EGJ and is useful when the HRM is normal. However, pressures that are currently being used to measure the EGJ distensibility by Endoflip are not physiological. Furthermore, esophageal body motor function assessed by a bag that distends a long segment of the esophagus under high pressure is unphysiological. The distension-contraction plots, which determines the luminal CSA and contraction simultaneously during primary peristalsis is ideally suited to study the pathophysiology of esophageal motility disorders. Several studies from my laboratory show that in patients with nutcracker esophagus, EGJOO and normal HRM, the esophagus distends significantly less than that of normal subjects during primary peristalsis. I suspect that an esophageal contraction pushing bolus through a narrow lumen esophagus is the cause of dysphagia sensation in many patients that have been labeled as functional dysphagia.

The last 2 decades have seen significant progress in the diagnosis of esophageal motility disorders using HRM, Endoflip, and distension-contraction plots of peristalsis. Furthermore, endoscopic treatment of achalasia and “achalasia-like syndromes” is revolutionary. What is desperately needed is an understanding of the pathogenesis of esophageal motor disorders, pharmacotherapy of esophageal symptoms, such as chest pain, proton pump inhibitor–resistant heartburn, and others because dysfunctional esophagus is a huge burden on health care expenditures worldwide.

Ravinder K. Mittal, MD, is a professor of medicine and gastroenterologist with UC San Diego Health. He has patent application pending on the computer software Dplots.

Body

 

16% of the U.S. population experience dysphagia, only half of whom seek medical care and the others manage their symptoms by modifying diet.

X-ray barium swallow and endoscopy with biopsy to exclude eosinophilic esophagitis are the initial tests for dysphagia diagnosis. If the above are normal, a high-resolution esophageal manometry impedance (HRMZ) is recommended to diagnose primary and secondary esophageal motility disorder.

Dr. Ravinder Mittal
Studies before and after the advent of HRM show that the primary esophageal motility disorders such as achalasia, diffuse esophageal spasm, and nutcracker esophagus/jackhammer esophagus when combined together, are seen in only about 20% of patients presenting with dysphagia symptom. Esophagogastric junction outflow obstruction (EGJOO), another primary esophageal motility disorder characterized by impaired lower esophageal sphincter relaxation (integrated relaxation pressure > 15) in the presence of normal peristalsis is seen in 5%-24% of patients with dysphagia.

However, only in a minority of patients is it likely to cause dysphagia because uncontrolled studies show that therapeutic strategies to address EGJOO (botox, dilation, and myotomy) relieve dysphagia symptoms in a minority of patients. Hence, in significant number of patients the cause of dysphagia symptoms remains obscure. It might be that our testing is inadequate, or possibly, patients have functional dysphagia (sensory dysfunction of the esophagus). My opinion is that it is the former.

The esophagus has only one simple function, that is, to transfer the pharyngeal pump driven, that is, swallowed contents to the stomach, for which its luminal cross-sectional area must be larger than that of the swallowed bolus and contraction (measured by manometry) behind the bolus must be of adequate strength. The latter is likely less relevant because humans eat in the upright position and gravity provides propulsion for the bolus. Stated simply, as long as esophagus can distend well and there is no resistance to the outflow at the EGJ, esophagus can achieve its goal. However, until recently, there was no single test to determine the distension and contraction, the two essential elements of primary esophageal peristalsis.

Endoscopy and x-ray barium swallow are tests to determine the luminal diameter but have limitations. Endoflip measures the opening function of the EGJ and is useful when the HRM is normal. However, pressures that are currently being used to measure the EGJ distensibility by Endoflip are not physiological. Furthermore, esophageal body motor function assessed by a bag that distends a long segment of the esophagus under high pressure is unphysiological. The distension-contraction plots, which determines the luminal CSA and contraction simultaneously during primary peristalsis is ideally suited to study the pathophysiology of esophageal motility disorders. Several studies from my laboratory show that in patients with nutcracker esophagus, EGJOO and normal HRM, the esophagus distends significantly less than that of normal subjects during primary peristalsis. I suspect that an esophageal contraction pushing bolus through a narrow lumen esophagus is the cause of dysphagia sensation in many patients that have been labeled as functional dysphagia.

The last 2 decades have seen significant progress in the diagnosis of esophageal motility disorders using HRM, Endoflip, and distension-contraction plots of peristalsis. Furthermore, endoscopic treatment of achalasia and “achalasia-like syndromes” is revolutionary. What is desperately needed is an understanding of the pathogenesis of esophageal motor disorders, pharmacotherapy of esophageal symptoms, such as chest pain, proton pump inhibitor–resistant heartburn, and others because dysfunctional esophagus is a huge burden on health care expenditures worldwide.

Ravinder K. Mittal, MD, is a professor of medicine and gastroenterologist with UC San Diego Health. He has patent application pending on the computer software Dplots.

Advancements in tools for assessing the function of the esophagus have led to important refinements in the diagnosis of achalasia and achalasia-like conditions, at a pace that has left the line-tracing technology considered to have debatable merit just 15 years ago “now as obsolete as a typewriter,” experts said recently in a review in Gastro Hep Advances.

“We have come to conceptualize esophageal motility disorders by specific aspects of physiological dysfunction,” wrote a trio of experts – Peter Kahrilas, MD, professor of medicine; Dustin Carlson, MD, MS, assistant professor of medicine, and John Pandolfino, MD, chief of gastroenterology and hepatology, all at Northwestern University, Chicago. “A major implication of this approach is a shift in management strategy toward rendering treatment in a phenotype-specific manner.”

High-resolution manometry (HRM) was trail-blazing, they said, as it replaced line-tracing manometry in evaluating the motility of the esophagus. HRM led to the subtyping of achalasia based on the three patterns of pressurization in the esophagus that are associated with obstruction at the esophagogastric junction. But the field has continued to advance.

“It has since become clear that obstructive physiology also occurs in syndromes besides achalasia involving the esophagogastric junction and/or distal esophagus,” Dr. Kahrilas, Dr. Carlson, and Dr. Pandolfino said. “In fact, obstructive physiology is increasingly recognized as the fundamental abnormality leading to the perception of dysphagia with esophageal motility disorders. This concept of obstructive physiology as the fundamental abnormality has substantially morphed the clinical management of esophageal motility disorders.”

HRM, has many limitations, but in cases of an uncertain achalasia diagnosis, functional luminal imaging probe (FLIP) technology can help, they said. FLIP can also help surgeons tailor myotomy procedures.

In FLIP, a probe is carefully filled with fluid, causing distension of the esophagus. In the test, the distensibility of the esophagogastric junction is measured. The procedure allows a more refined assessment of the movement of the esophagus, and the subtypes of achalasia.

Identifying the achalasia subtype is crucial to choosing the right treatment, data suggests. There have been no randomized controlled trials on achalasia management that prospectively consider achalasia subtype, but retrospective analysis of RCT data “suggests that achalasia subtypes are of great relevance in forecasting treatment effectiveness,” they said.

In one trial, pneumatic dilation was effective in 100% of type II achalasia, which involves panesophageal pressurization, significantly better than laparoscopic Heller myotomy (LHM). But it was much less effective than LHM in type III achalasia, the spastic form, although a significance couldn’t be established because of the number of cases. Data from a meta-analysis showed that peroral endoscopic myotomy, which allows for a longer myotomy if needed, was better than LHM for classic achalasia and spastic achalasia and was most efficacious overall.

The writers said that the diagnostic classifications for achalasia are likely to continue to evolve, pointing to the dynamic nature of the Chicago Classification for the disorder.

“The fact that it has now gone through four iterations since 2008 emphasizes that this is a work in progress and that no classification scheme of esophageal motility disorders based on a single test will ever be perfect,” they said. “After all, there are no biomarkers of esophageal motility disorders and, in the absence of a biomarker, there can be no ‘gold standard’ for diagnosis.”

Dr. Pandolfino, Dr. Kahrilas, and Northwestern University hold shared intellectual property rights and ownership surrounding FLIP Panometry systems, methods, and apparatus with Medtronic. Dr. Kahrilas reported consulting with Ironwood, Reckitt, and Phathom. Dr. Carlson reported conflicts of interest with Medtronic and Phathom Pharmaceuticals. Dr. Pandolfino reported conflicts of interest with Sandhill Scientific/Diversatek, Takeda, AstraZeneca, Medtronic, Torax, and Ironwood.

Advancements in tools for assessing the function of the esophagus have led to important refinements in the diagnosis of achalasia and achalasia-like conditions, at a pace that has left the line-tracing technology considered to have debatable merit just 15 years ago “now as obsolete as a typewriter,” experts said recently in a review in Gastro Hep Advances.

“We have come to conceptualize esophageal motility disorders by specific aspects of physiological dysfunction,” wrote a trio of experts – Peter Kahrilas, MD, professor of medicine; Dustin Carlson, MD, MS, assistant professor of medicine, and John Pandolfino, MD, chief of gastroenterology and hepatology, all at Northwestern University, Chicago. “A major implication of this approach is a shift in management strategy toward rendering treatment in a phenotype-specific manner.”

High-resolution manometry (HRM) was trail-blazing, they said, as it replaced line-tracing manometry in evaluating the motility of the esophagus. HRM led to the subtyping of achalasia based on the three patterns of pressurization in the esophagus that are associated with obstruction at the esophagogastric junction. But the field has continued to advance.

“It has since become clear that obstructive physiology also occurs in syndromes besides achalasia involving the esophagogastric junction and/or distal esophagus,” Dr. Kahrilas, Dr. Carlson, and Dr. Pandolfino said. “In fact, obstructive physiology is increasingly recognized as the fundamental abnormality leading to the perception of dysphagia with esophageal motility disorders. This concept of obstructive physiology as the fundamental abnormality has substantially morphed the clinical management of esophageal motility disorders.”

HRM, has many limitations, but in cases of an uncertain achalasia diagnosis, functional luminal imaging probe (FLIP) technology can help, they said. FLIP can also help surgeons tailor myotomy procedures.

In FLIP, a probe is carefully filled with fluid, causing distension of the esophagus. In the test, the distensibility of the esophagogastric junction is measured. The procedure allows a more refined assessment of the movement of the esophagus, and the subtypes of achalasia.

Identifying the achalasia subtype is crucial to choosing the right treatment, data suggests. There have been no randomized controlled trials on achalasia management that prospectively consider achalasia subtype, but retrospective analysis of RCT data “suggests that achalasia subtypes are of great relevance in forecasting treatment effectiveness,” they said.

In one trial, pneumatic dilation was effective in 100% of type II achalasia, which involves panesophageal pressurization, significantly better than laparoscopic Heller myotomy (LHM). But it was much less effective than LHM in type III achalasia, the spastic form, although a significance couldn’t be established because of the number of cases. Data from a meta-analysis showed that peroral endoscopic myotomy, which allows for a longer myotomy if needed, was better than LHM for classic achalasia and spastic achalasia and was most efficacious overall.

The writers said that the diagnostic classifications for achalasia are likely to continue to evolve, pointing to the dynamic nature of the Chicago Classification for the disorder.

“The fact that it has now gone through four iterations since 2008 emphasizes that this is a work in progress and that no classification scheme of esophageal motility disorders based on a single test will ever be perfect,” they said. “After all, there are no biomarkers of esophageal motility disorders and, in the absence of a biomarker, there can be no ‘gold standard’ for diagnosis.”

Dr. Pandolfino, Dr. Kahrilas, and Northwestern University hold shared intellectual property rights and ownership surrounding FLIP Panometry systems, methods, and apparatus with Medtronic. Dr. Kahrilas reported consulting with Ironwood, Reckitt, and Phathom. Dr. Carlson reported conflicts of interest with Medtronic and Phathom Pharmaceuticals. Dr. Pandolfino reported conflicts of interest with Sandhill Scientific/Diversatek, Takeda, AstraZeneca, Medtronic, Torax, and Ironwood.

Publications
Publications
Topics
Article Type
Sections
Article Source

FROM GASTRO HEP ADVANCES 

Disallow All Ads
Content Gating
No Gating (article Unlocked/Free)
Alternative CME
Disqus Comments
Default
Use ProPublica
Hide sidebar & use full width
render the right sidebar.
Conference Recap Checkbox
Not Conference Recap
Clinical Edge
Display the Slideshow in this Article
Medscape Article
Display survey writer
Reuters content
Disable Inline Native ads
WebMD Article

News & Perspectives from Ob.Gyn. News

Article Type
Changed
Tue, 08/15/2023 - 08:55

 

NEWS FROM THE FDA/CDC

FDA approves first over-the-counter birth control pill

The Food and Drug Administration’s approval today of the first birth control pill for women to be available without a prescription is being hailed by many as a long-needed development, but there remain questions to be resolved, including how much the drug will cost and how it will be used.

The drug, Opill, is expected to be available early next year, and its maker has yet to reveal a retail price. It is the same birth control pill that has been available by prescription for 50 years. But for the first time, women will be able to buy the contraception at a local pharmacy, other retail locations, or online without having to see a doctor first.

 

Likely to drive debate

Contraception in the United States is not without controversy. The FDA’s approval spurred reactions both for and against making hormonal birth control for women available without a prescription.

“It’s an exciting time, especially right now when reproductive rights are being curtailed in a lot of states. Giving people an additional option for contraception will change people’s lives,” said Beverly Gray, MD, division director of Women’s Community and Population Health at Duke University Medical Center in Durham, N.C.

https://www.mdedge.com/obgyn/news-fda/cdc

FEATURE

U.S. mammogram update sparks concern, reignites debates

A recent update to the U.S. recommendations for breast cancer screening is raising concerns about the costs associated with potential follow-up tests, while also renewing debates about the timing of these tests and the screening approaches used.

The U.S. Preventive Services Task Force is currently finalizing an update to its recommendations on breast cancer screening. In May, the task force released a proposed update that dropped the initial age for routine mammogram screening from 50 to 40.

The task force intends to give a “B” rating to this recommendation, which covers screening every other year up to age 74 for women deemed average risk for breast cancer.

The task force’s rating carries clout, A. Mark Fendrick, MD, director of the Value-Based Insurance Design at the University of Michigan, Ann Arbor, said in an interview.

For one, the Affordable Care Act requires that private insurers cover services that get top A or B marks from USPSTF without charging copays.

However, Dr. Fendrick noted, such coverage does not necessarily apply to follow-up testing when a routine mammogram comes back with a positive finding. The expense of follow-up testing may deter some women from seeking follow-up diagnostic imaging or biopsies after an abnormal result on a screen­­-ing mammogram.

A recent analysis in JAMA Network Open found that women facing higher anticipated out-of-pocket costs for breast cancer diagnostic tests, based on their health insurance plan, were less likely to get that follow-up screening. For instance, the use of breast MRI decreased by nearly 24% between patients undergoing subsequent diagnostic testing in plans with the lowest out-of-pocket costs vs. those with the highest.

https://www.mdedge.com/obgyn/article/264198/breast-cancer/us-mammogram-update-sparks-concern-reignites-debates




Continue to: GENDER-AFFIRMING GYNECOLOGY...

 

 

GENDER-AFFIRMING GYNECOLOGY

Updates on pregnancy outcomes in transgender men

Despite increased societal gains, transgender individuals are still a medically and socially underserved group. The historic rise of antitransgender legislation and the overturning of Roe v. Wade, further compound existing health care disparities, particularly in the realm of contraception and pregnancy. Obstetrician-gynecologistsand midwives are typically first-line providers when discussing family planning and fertility options for all patients assigned female at birth. Unfortunately, compared with the surgical, hormonal, and mental health aspects of gender-affirming care, fertility and pregnancy in transgender men is still a relatively new and under-researched topic.

Only individuals who are assigned female at birth and have a uterus are capable of pregnancy. This can include both cisgender women and nonbinary/transgender men. However, societal and medical institutions are struggling with this shift in perspective from a traditionally gendered role to a more inclusive one. Obstetrician-gynecologists and midwives can serve to bridge this gap between these patients and societal misconceptions surrounding transgender men who desire and experience pregnancy.

 


Providers need to remember that many transmasculine individuals will still retain their uterus and are therefore capable of getting pregnant. While testosterone causes amenorrhea, if patients are engaging in penile-vaginal intercourse, conception is still possible. If a patient does not desire pregnancy, all contraceptive options available for cisgender women, which also include combined oral contraceptives, should be offered.

https://www.mdedge.com/obgyn/gender-affirming-gynecology


REPRODUCTIVE ROUNDS

Affordable IVF—Are we there yet?

The price for an in vitro fertilization (IVF) cycle continues to increase annually by many clinics, particularly because of “add-ons” of dubious value.

The initial application of IVF was for tubal factor infertility. Over the decades since 1981, the year of the first successful live birth in the United States, indications for IVF have dramatically expanded—ovulation dysfunction, unexplained infertility, male factor, advanced stage endometriosis, unexplained infertility, embryo testing to avoid an inherited genetic disease from the intended parents carrying the same mutation, and family balancing for gender, along with fertility preservation, including before potentially gonadotoxic treatment and “elective” planned oocyte cryopreservation.

The cost of IVF remains a significant, and possibly leading, stumbling block for women, couples, and men who lack insurance coverage. From RESOLVE.org, the National Infertility Association: “As of June 2022, 20 states have passed fertility insurance coverage laws, 14 of those laws include IVF coverage, and 12 states have fertility preservation laws for iatrogenic (medically induced) infertility.” Consequently, “affordable IVF” is paramount to providing equal access for patients.

https://www.mdedge.com/obgyn/reproductive-rounds


CONFERENCE COVERAGE

‘Artificial pancreas’ for all type 1 diabetes pregnancies?

In the largest randomized controlled trial of an automated insulin delivery (AID) system (hybrid closed-loop) versus standard insulin delivery in pregnant women with type 1 diabetes, the automated CamAPS FX system prevailed.

The percentage of time spent in the pregnancy-specific target blood glucose range of 63-140 mg/dL (3.5-7.8 mmol/L) from 16 weeks’ gestation to delivery was significantly higher in women in the AID group.

Helen R. Murphy, MD, presented these topline findings from the Automated Insulin Delivery Amongst Pregnant Women With Type 1 Diabetes (AiDAPT) trial during an e-poster session at the annual scientific sessions of the American Diabetes Association.

The “hybrid closed-loop significantly improved maternal glucose and should be offered to all pregnant women with type 1 diabetes,” concluded Dr. Murphy, professor of medicine at the University of East Anglia and a clinician at Norfolk and Norwich University Hospital in the United Kingdom.

CamAPS FX is the only AID system approved in Europe and the United Kingdom for type 1 diabetes from age 1 and during pregnancy. The hybrid closed-loop system is not available in the United States but other systems are available and sometimes used off label in pregnancy. Such systems are sometimes known colloquially as an “artificial pancreas.”

The researchers said their findings provide evidence for the UK National Institute of Clinical Excellence (NICE) to recommend that all pregnant women with type 1 diabetes should be offered the CamAPS FX system.

https://www.mdedge.com/obgyn/conference-coverage

Article PDF
Issue
OBG Management - 35(8)
Publications
Topics
Page Number
45-46
Sections
Article PDF
Article PDF

 

NEWS FROM THE FDA/CDC

FDA approves first over-the-counter birth control pill

The Food and Drug Administration’s approval today of the first birth control pill for women to be available without a prescription is being hailed by many as a long-needed development, but there remain questions to be resolved, including how much the drug will cost and how it will be used.

The drug, Opill, is expected to be available early next year, and its maker has yet to reveal a retail price. It is the same birth control pill that has been available by prescription for 50 years. But for the first time, women will be able to buy the contraception at a local pharmacy, other retail locations, or online without having to see a doctor first.

 

Likely to drive debate

Contraception in the United States is not without controversy. The FDA’s approval spurred reactions both for and against making hormonal birth control for women available without a prescription.

“It’s an exciting time, especially right now when reproductive rights are being curtailed in a lot of states. Giving people an additional option for contraception will change people’s lives,” said Beverly Gray, MD, division director of Women’s Community and Population Health at Duke University Medical Center in Durham, N.C.

https://www.mdedge.com/obgyn/news-fda/cdc

FEATURE

U.S. mammogram update sparks concern, reignites debates

A recent update to the U.S. recommendations for breast cancer screening is raising concerns about the costs associated with potential follow-up tests, while also renewing debates about the timing of these tests and the screening approaches used.

The U.S. Preventive Services Task Force is currently finalizing an update to its recommendations on breast cancer screening. In May, the task force released a proposed update that dropped the initial age for routine mammogram screening from 50 to 40.

The task force intends to give a “B” rating to this recommendation, which covers screening every other year up to age 74 for women deemed average risk for breast cancer.

The task force’s rating carries clout, A. Mark Fendrick, MD, director of the Value-Based Insurance Design at the University of Michigan, Ann Arbor, said in an interview.

For one, the Affordable Care Act requires that private insurers cover services that get top A or B marks from USPSTF without charging copays.

However, Dr. Fendrick noted, such coverage does not necessarily apply to follow-up testing when a routine mammogram comes back with a positive finding. The expense of follow-up testing may deter some women from seeking follow-up diagnostic imaging or biopsies after an abnormal result on a screen­­-ing mammogram.

A recent analysis in JAMA Network Open found that women facing higher anticipated out-of-pocket costs for breast cancer diagnostic tests, based on their health insurance plan, were less likely to get that follow-up screening. For instance, the use of breast MRI decreased by nearly 24% between patients undergoing subsequent diagnostic testing in plans with the lowest out-of-pocket costs vs. those with the highest.

https://www.mdedge.com/obgyn/article/264198/breast-cancer/us-mammogram-update-sparks-concern-reignites-debates




Continue to: GENDER-AFFIRMING GYNECOLOGY...

 

 

GENDER-AFFIRMING GYNECOLOGY

Updates on pregnancy outcomes in transgender men

Despite increased societal gains, transgender individuals are still a medically and socially underserved group. The historic rise of antitransgender legislation and the overturning of Roe v. Wade, further compound existing health care disparities, particularly in the realm of contraception and pregnancy. Obstetrician-gynecologistsand midwives are typically first-line providers when discussing family planning and fertility options for all patients assigned female at birth. Unfortunately, compared with the surgical, hormonal, and mental health aspects of gender-affirming care, fertility and pregnancy in transgender men is still a relatively new and under-researched topic.

Only individuals who are assigned female at birth and have a uterus are capable of pregnancy. This can include both cisgender women and nonbinary/transgender men. However, societal and medical institutions are struggling with this shift in perspective from a traditionally gendered role to a more inclusive one. Obstetrician-gynecologists and midwives can serve to bridge this gap between these patients and societal misconceptions surrounding transgender men who desire and experience pregnancy.

 


Providers need to remember that many transmasculine individuals will still retain their uterus and are therefore capable of getting pregnant. While testosterone causes amenorrhea, if patients are engaging in penile-vaginal intercourse, conception is still possible. If a patient does not desire pregnancy, all contraceptive options available for cisgender women, which also include combined oral contraceptives, should be offered.

https://www.mdedge.com/obgyn/gender-affirming-gynecology


REPRODUCTIVE ROUNDS

Affordable IVF—Are we there yet?

The price for an in vitro fertilization (IVF) cycle continues to increase annually by many clinics, particularly because of “add-ons” of dubious value.

The initial application of IVF was for tubal factor infertility. Over the decades since 1981, the year of the first successful live birth in the United States, indications for IVF have dramatically expanded—ovulation dysfunction, unexplained infertility, male factor, advanced stage endometriosis, unexplained infertility, embryo testing to avoid an inherited genetic disease from the intended parents carrying the same mutation, and family balancing for gender, along with fertility preservation, including before potentially gonadotoxic treatment and “elective” planned oocyte cryopreservation.

The cost of IVF remains a significant, and possibly leading, stumbling block for women, couples, and men who lack insurance coverage. From RESOLVE.org, the National Infertility Association: “As of June 2022, 20 states have passed fertility insurance coverage laws, 14 of those laws include IVF coverage, and 12 states have fertility preservation laws for iatrogenic (medically induced) infertility.” Consequently, “affordable IVF” is paramount to providing equal access for patients.

https://www.mdedge.com/obgyn/reproductive-rounds


CONFERENCE COVERAGE

‘Artificial pancreas’ for all type 1 diabetes pregnancies?

In the largest randomized controlled trial of an automated insulin delivery (AID) system (hybrid closed-loop) versus standard insulin delivery in pregnant women with type 1 diabetes, the automated CamAPS FX system prevailed.

The percentage of time spent in the pregnancy-specific target blood glucose range of 63-140 mg/dL (3.5-7.8 mmol/L) from 16 weeks’ gestation to delivery was significantly higher in women in the AID group.

Helen R. Murphy, MD, presented these topline findings from the Automated Insulin Delivery Amongst Pregnant Women With Type 1 Diabetes (AiDAPT) trial during an e-poster session at the annual scientific sessions of the American Diabetes Association.

The “hybrid closed-loop significantly improved maternal glucose and should be offered to all pregnant women with type 1 diabetes,” concluded Dr. Murphy, professor of medicine at the University of East Anglia and a clinician at Norfolk and Norwich University Hospital in the United Kingdom.

CamAPS FX is the only AID system approved in Europe and the United Kingdom for type 1 diabetes from age 1 and during pregnancy. The hybrid closed-loop system is not available in the United States but other systems are available and sometimes used off label in pregnancy. Such systems are sometimes known colloquially as an “artificial pancreas.”

The researchers said their findings provide evidence for the UK National Institute of Clinical Excellence (NICE) to recommend that all pregnant women with type 1 diabetes should be offered the CamAPS FX system.

https://www.mdedge.com/obgyn/conference-coverage

 

NEWS FROM THE FDA/CDC

FDA approves first over-the-counter birth control pill

The Food and Drug Administration’s approval today of the first birth control pill for women to be available without a prescription is being hailed by many as a long-needed development, but there remain questions to be resolved, including how much the drug will cost and how it will be used.

The drug, Opill, is expected to be available early next year, and its maker has yet to reveal a retail price. It is the same birth control pill that has been available by prescription for 50 years. But for the first time, women will be able to buy the contraception at a local pharmacy, other retail locations, or online without having to see a doctor first.

 

Likely to drive debate

Contraception in the United States is not without controversy. The FDA’s approval spurred reactions both for and against making hormonal birth control for women available without a prescription.

“It’s an exciting time, especially right now when reproductive rights are being curtailed in a lot of states. Giving people an additional option for contraception will change people’s lives,” said Beverly Gray, MD, division director of Women’s Community and Population Health at Duke University Medical Center in Durham, N.C.

https://www.mdedge.com/obgyn/news-fda/cdc

FEATURE

U.S. mammogram update sparks concern, reignites debates

A recent update to the U.S. recommendations for breast cancer screening is raising concerns about the costs associated with potential follow-up tests, while also renewing debates about the timing of these tests and the screening approaches used.

The U.S. Preventive Services Task Force is currently finalizing an update to its recommendations on breast cancer screening. In May, the task force released a proposed update that dropped the initial age for routine mammogram screening from 50 to 40.

The task force intends to give a “B” rating to this recommendation, which covers screening every other year up to age 74 for women deemed average risk for breast cancer.

The task force’s rating carries clout, A. Mark Fendrick, MD, director of the Value-Based Insurance Design at the University of Michigan, Ann Arbor, said in an interview.

For one, the Affordable Care Act requires that private insurers cover services that get top A or B marks from USPSTF without charging copays.

However, Dr. Fendrick noted, such coverage does not necessarily apply to follow-up testing when a routine mammogram comes back with a positive finding. The expense of follow-up testing may deter some women from seeking follow-up diagnostic imaging or biopsies after an abnormal result on a screen­­-ing mammogram.

A recent analysis in JAMA Network Open found that women facing higher anticipated out-of-pocket costs for breast cancer diagnostic tests, based on their health insurance plan, were less likely to get that follow-up screening. For instance, the use of breast MRI decreased by nearly 24% between patients undergoing subsequent diagnostic testing in plans with the lowest out-of-pocket costs vs. those with the highest.

https://www.mdedge.com/obgyn/article/264198/breast-cancer/us-mammogram-update-sparks-concern-reignites-debates




Continue to: GENDER-AFFIRMING GYNECOLOGY...

 

 

GENDER-AFFIRMING GYNECOLOGY

Updates on pregnancy outcomes in transgender men

Despite increased societal gains, transgender individuals are still a medically and socially underserved group. The historic rise of antitransgender legislation and the overturning of Roe v. Wade, further compound existing health care disparities, particularly in the realm of contraception and pregnancy. Obstetrician-gynecologistsand midwives are typically first-line providers when discussing family planning and fertility options for all patients assigned female at birth. Unfortunately, compared with the surgical, hormonal, and mental health aspects of gender-affirming care, fertility and pregnancy in transgender men is still a relatively new and under-researched topic.

Only individuals who are assigned female at birth and have a uterus are capable of pregnancy. This can include both cisgender women and nonbinary/transgender men. However, societal and medical institutions are struggling with this shift in perspective from a traditionally gendered role to a more inclusive one. Obstetrician-gynecologists and midwives can serve to bridge this gap between these patients and societal misconceptions surrounding transgender men who desire and experience pregnancy.

 


Providers need to remember that many transmasculine individuals will still retain their uterus and are therefore capable of getting pregnant. While testosterone causes amenorrhea, if patients are engaging in penile-vaginal intercourse, conception is still possible. If a patient does not desire pregnancy, all contraceptive options available for cisgender women, which also include combined oral contraceptives, should be offered.

https://www.mdedge.com/obgyn/gender-affirming-gynecology


REPRODUCTIVE ROUNDS

Affordable IVF—Are we there yet?

The price for an in vitro fertilization (IVF) cycle continues to increase annually by many clinics, particularly because of “add-ons” of dubious value.

The initial application of IVF was for tubal factor infertility. Over the decades since 1981, the year of the first successful live birth in the United States, indications for IVF have dramatically expanded—ovulation dysfunction, unexplained infertility, male factor, advanced stage endometriosis, unexplained infertility, embryo testing to avoid an inherited genetic disease from the intended parents carrying the same mutation, and family balancing for gender, along with fertility preservation, including before potentially gonadotoxic treatment and “elective” planned oocyte cryopreservation.

The cost of IVF remains a significant, and possibly leading, stumbling block for women, couples, and men who lack insurance coverage. From RESOLVE.org, the National Infertility Association: “As of June 2022, 20 states have passed fertility insurance coverage laws, 14 of those laws include IVF coverage, and 12 states have fertility preservation laws for iatrogenic (medically induced) infertility.” Consequently, “affordable IVF” is paramount to providing equal access for patients.

https://www.mdedge.com/obgyn/reproductive-rounds


CONFERENCE COVERAGE

‘Artificial pancreas’ for all type 1 diabetes pregnancies?

In the largest randomized controlled trial of an automated insulin delivery (AID) system (hybrid closed-loop) versus standard insulin delivery in pregnant women with type 1 diabetes, the automated CamAPS FX system prevailed.

The percentage of time spent in the pregnancy-specific target blood glucose range of 63-140 mg/dL (3.5-7.8 mmol/L) from 16 weeks’ gestation to delivery was significantly higher in women in the AID group.

Helen R. Murphy, MD, presented these topline findings from the Automated Insulin Delivery Amongst Pregnant Women With Type 1 Diabetes (AiDAPT) trial during an e-poster session at the annual scientific sessions of the American Diabetes Association.

The “hybrid closed-loop significantly improved maternal glucose and should be offered to all pregnant women with type 1 diabetes,” concluded Dr. Murphy, professor of medicine at the University of East Anglia and a clinician at Norfolk and Norwich University Hospital in the United Kingdom.

CamAPS FX is the only AID system approved in Europe and the United Kingdom for type 1 diabetes from age 1 and during pregnancy. The hybrid closed-loop system is not available in the United States but other systems are available and sometimes used off label in pregnancy. Such systems are sometimes known colloquially as an “artificial pancreas.”

The researchers said their findings provide evidence for the UK National Institute of Clinical Excellence (NICE) to recommend that all pregnant women with type 1 diabetes should be offered the CamAPS FX system.

https://www.mdedge.com/obgyn/conference-coverage

Issue
OBG Management - 35(8)
Issue
OBG Management - 35(8)
Page Number
45-46
Page Number
45-46
Publications
Publications
Topics
Article Type
Sections
Disallow All Ads
Content Gating
No Gating (article Unlocked/Free)
Alternative CME
Disqus Comments
Default
Use ProPublica
Hide sidebar & use full width
render the right sidebar.
Conference Recap Checkbox
Not Conference Recap
Clinical Edge
Display the Slideshow in this Article
Medscape Article
Display survey writer
Reuters content
Disable Inline Native ads
WebMD Article
Article PDF Media

Fluctuant facial lesions

Article Type
Changed
Wed, 11/01/2023 - 08:09
Display Headline
Fluctuant facial lesions

Fluctuant facial lesions

This patient had more than cystic acne; he had acne conglobata. AC is a severe form of inflammatory acne leading to coalescing lesions with purulent sinus tracts under the skin. It can be seen as part of the follicular tetrad syndrome of cystic acne, hidradenitis suppurativa, dissecting cellulitis, and pilonidal disease. AC is thought to be an elevated tumor necrosis factor (TNF)-alpha response to Propionibacterium acnes (now known as Cutibacterium acnes) that leads to excessive inflammation and sterile abscesses.1 Acne fulminans (AF) can also manifest as a purulent form of acne, but AF has associated systemic signs and symptoms that include fevers, chills, and malaise.

Due to the depth of the inflammation, AC is treated with systemic medications, most commonly isotretinoin. Isotretinoin can be started at 0.5 mg/kg (divided twice daily to enhance tolerability) and then increased to 1 mg/kg (divided twice daily) for 5 months. There is some variation in dosing regimens in practice; the target goal is 120 to 150 mg/kg over the course of treatment. In AF, the patient is pretreated with systemic steroids, and in AC, some clinicians will even prescribe systemic steroids (prednisone 0.5 mg/kg daily for the first month) along with isotretinoin.

Second-line medications include dapsone (50-150 mg/d).2 Case reports describe the successful use of the TNF-alpha antagonist adalimumab, although this is not a usual practice in AC treatment.1 Note that all of these medications have the potential for severe adverse effects and require laboratory evaluation prior to initiation.

This patient was counseled, prescribed isotretinoin (dose as above), and enrolled in the IPledge prescribing and monitoring system for isotretinoin. At 20 weeks of use, the purulent drainage ceased. The pus-filled sinus tracts and redness had resolved, although he still had thickened tissue and scarring where the tracts had been. In time, the scars will usually get flatter and softer.

If the patient’s AC were to flare, another 20-week course of isotretinoin could be prescribed after a 2-month hiatus or he could be switched to a second-line medication. Referral for any cosmetic therapy is typically delayed for another 6 months in case there is a need to treat a recurrence.

Photo and text courtesy of Daniel Stulberg, MD, FAAFP, Professor and Chair, Department of Family and Community Medicine, Western Michigan University Homer Stryker, MD School of Medicine, Kalamazoo.

References

1. Yiu ZZ, Madan V, Griffiths CE. Acne conglobata and adalimumab: use of tumour necrosis factor-α antagonists in treatment-resistant acne conglobata, and review of the literature. Clin Exp Dermatol. 2015;40:383-386. doi: 10.1111/ced.12540

2. Hafsi W, Arnold DL, Kassardjian M. Acne Conglobata. StatPearls Publishing; 2023.

Issue
The Journal of Family Practice - 72(6)
Publications
Topics
Sections

Fluctuant facial lesions

This patient had more than cystic acne; he had acne conglobata. AC is a severe form of inflammatory acne leading to coalescing lesions with purulent sinus tracts under the skin. It can be seen as part of the follicular tetrad syndrome of cystic acne, hidradenitis suppurativa, dissecting cellulitis, and pilonidal disease. AC is thought to be an elevated tumor necrosis factor (TNF)-alpha response to Propionibacterium acnes (now known as Cutibacterium acnes) that leads to excessive inflammation and sterile abscesses.1 Acne fulminans (AF) can also manifest as a purulent form of acne, but AF has associated systemic signs and symptoms that include fevers, chills, and malaise.

Due to the depth of the inflammation, AC is treated with systemic medications, most commonly isotretinoin. Isotretinoin can be started at 0.5 mg/kg (divided twice daily to enhance tolerability) and then increased to 1 mg/kg (divided twice daily) for 5 months. There is some variation in dosing regimens in practice; the target goal is 120 to 150 mg/kg over the course of treatment. In AF, the patient is pretreated with systemic steroids, and in AC, some clinicians will even prescribe systemic steroids (prednisone 0.5 mg/kg daily for the first month) along with isotretinoin.

Second-line medications include dapsone (50-150 mg/d).2 Case reports describe the successful use of the TNF-alpha antagonist adalimumab, although this is not a usual practice in AC treatment.1 Note that all of these medications have the potential for severe adverse effects and require laboratory evaluation prior to initiation.

This patient was counseled, prescribed isotretinoin (dose as above), and enrolled in the IPledge prescribing and monitoring system for isotretinoin. At 20 weeks of use, the purulent drainage ceased. The pus-filled sinus tracts and redness had resolved, although he still had thickened tissue and scarring where the tracts had been. In time, the scars will usually get flatter and softer.

If the patient’s AC were to flare, another 20-week course of isotretinoin could be prescribed after a 2-month hiatus or he could be switched to a second-line medication. Referral for any cosmetic therapy is typically delayed for another 6 months in case there is a need to treat a recurrence.

Photo and text courtesy of Daniel Stulberg, MD, FAAFP, Professor and Chair, Department of Family and Community Medicine, Western Michigan University Homer Stryker, MD School of Medicine, Kalamazoo.

Fluctuant facial lesions

This patient had more than cystic acne; he had acne conglobata. AC is a severe form of inflammatory acne leading to coalescing lesions with purulent sinus tracts under the skin. It can be seen as part of the follicular tetrad syndrome of cystic acne, hidradenitis suppurativa, dissecting cellulitis, and pilonidal disease. AC is thought to be an elevated tumor necrosis factor (TNF)-alpha response to Propionibacterium acnes (now known as Cutibacterium acnes) that leads to excessive inflammation and sterile abscesses.1 Acne fulminans (AF) can also manifest as a purulent form of acne, but AF has associated systemic signs and symptoms that include fevers, chills, and malaise.

Due to the depth of the inflammation, AC is treated with systemic medications, most commonly isotretinoin. Isotretinoin can be started at 0.5 mg/kg (divided twice daily to enhance tolerability) and then increased to 1 mg/kg (divided twice daily) for 5 months. There is some variation in dosing regimens in practice; the target goal is 120 to 150 mg/kg over the course of treatment. In AF, the patient is pretreated with systemic steroids, and in AC, some clinicians will even prescribe systemic steroids (prednisone 0.5 mg/kg daily for the first month) along with isotretinoin.

Second-line medications include dapsone (50-150 mg/d).2 Case reports describe the successful use of the TNF-alpha antagonist adalimumab, although this is not a usual practice in AC treatment.1 Note that all of these medications have the potential for severe adverse effects and require laboratory evaluation prior to initiation.

This patient was counseled, prescribed isotretinoin (dose as above), and enrolled in the IPledge prescribing and monitoring system for isotretinoin. At 20 weeks of use, the purulent drainage ceased. The pus-filled sinus tracts and redness had resolved, although he still had thickened tissue and scarring where the tracts had been. In time, the scars will usually get flatter and softer.

If the patient’s AC were to flare, another 20-week course of isotretinoin could be prescribed after a 2-month hiatus or he could be switched to a second-line medication. Referral for any cosmetic therapy is typically delayed for another 6 months in case there is a need to treat a recurrence.

Photo and text courtesy of Daniel Stulberg, MD, FAAFP, Professor and Chair, Department of Family and Community Medicine, Western Michigan University Homer Stryker, MD School of Medicine, Kalamazoo.

References

1. Yiu ZZ, Madan V, Griffiths CE. Acne conglobata and adalimumab: use of tumour necrosis factor-α antagonists in treatment-resistant acne conglobata, and review of the literature. Clin Exp Dermatol. 2015;40:383-386. doi: 10.1111/ced.12540

2. Hafsi W, Arnold DL, Kassardjian M. Acne Conglobata. StatPearls Publishing; 2023.

References

1. Yiu ZZ, Madan V, Griffiths CE. Acne conglobata and adalimumab: use of tumour necrosis factor-α antagonists in treatment-resistant acne conglobata, and review of the literature. Clin Exp Dermatol. 2015;40:383-386. doi: 10.1111/ced.12540

2. Hafsi W, Arnold DL, Kassardjian M. Acne Conglobata. StatPearls Publishing; 2023.

Issue
The Journal of Family Practice - 72(6)
Issue
The Journal of Family Practice - 72(6)
Publications
Publications
Topics
Article Type
Display Headline
Fluctuant facial lesions
Display Headline
Fluctuant facial lesions
Sections
Disallow All Ads
Content Gating
No Gating (article Unlocked/Free)
Alternative CME
Disqus Comments
Default
Gate On Date
Tue, 08/15/2023 - 07:45
Un-Gate On Date
Tue, 08/15/2023 - 07:45
Use ProPublica
CFC Schedule Remove Status
Tue, 08/15/2023 - 07:45
Hide sidebar & use full width
render the right sidebar.
Conference Recap Checkbox
Not Conference Recap
Clinical Edge
Display the Slideshow in this Article
Medscape Article
Display survey writer
Reuters content
Disable Inline Native ads
WebMD Article

Leathery plaque on thigh

Article Type
Changed
Wed, 09/20/2023 - 08:40
Display Headline
Leathery plaque on thigh

Leathery plaque on thigh

The necrotic eschar on this patient’s thigh is calciphylaxis, also known as calcific uremic arteriolopathy (CUA). Most cases are seen in ESRD and start as painful erythematous, firm lesions that progress to necrotic eschars. Up to 4% of patients with ESRD who are on dialysis develop CUA.1

The exact pathology of CUA is unknown. Calcification of the arterioles leads to ischemia and necrosis of tissue, which is not limited to the skin and can affect tissue elsewhere (eg, muscles, central nervous system, internal organs).2

Morbidity and mortality of CUA is often due to bacterial infections and sepsis related to the necrotic tissue. CUA can be treated with sodium thiosulfate (25 g in 100 mL of normal saline) infused intravenously during the last 30 minutes of dialysis treatment 3 times per week.3 Sodium thiosulfate (which acts as a calcium binder) and cinacalcet (a calcimimetic that leads to lower parathyroid hormone levels) have been used, but evidence of efficacy is limited. In a multicenter observational study involving 89 patients with chronic kidney disease and CUA, 17% of patients experienced complete wound healing, while 56% died over a median follow-up period of 5.8 months.1 (No cause of death data were available; sodium thiosulfate and a calcimimetic were the most widely used treatment strategies.) This extrapolated to a mortality rate of 72 patients per 100 individuals over the course of 1 year (the 100 patient-years rate).1

This patient continued her dialysis regimen and general care. She was seen by the wound care team and treated with topical wound care, including moist dressings for her open lesions. The eschars were not debrided because they showed no sign of active infection. Unfortunately, she was in extremely frail condition and died 1 month after evaluation.

Photo and text courtesy of Daniel Stulberg, MD, FAAFP, Professor and Chair, Department of Family and Community Medicine, Western Michigan University Homer Stryker, MD School of Medicine, Kalamazoo.

References

1. Chinnadurai R, Huckle A, Hegarty J, et al. Calciphylaxis in end-stage kidney disease: outcome data from the United Kingdom Calciphylaxis Study. J Nephrol. 2021;34:1537-1545. doi: 10.1007/s40620-020-00908-9

2. Nigwekar SU, Kroshinsky D, Nazarian RM, et al. Calciphylaxis: risk factors, diagnosis, and treatment. Am J Kidney Dis. 2015;66:133-146. doi: 10.1053/j.ajkd.2015.01.034

3. Nigwekar SU, Kroshinsky D, Nazarian RM, et al. Calciphylaxis: risk factors, diagnosis, and treatment. Am J Kidney Dis. 2015;66:133-146. doi: 10.1053/j.ajkd.2015.01.034

Issue
The Journal of Family Practice - 72(6)
Publications
Topics
Sections

Leathery plaque on thigh

The necrotic eschar on this patient’s thigh is calciphylaxis, also known as calcific uremic arteriolopathy (CUA). Most cases are seen in ESRD and start as painful erythematous, firm lesions that progress to necrotic eschars. Up to 4% of patients with ESRD who are on dialysis develop CUA.1

The exact pathology of CUA is unknown. Calcification of the arterioles leads to ischemia and necrosis of tissue, which is not limited to the skin and can affect tissue elsewhere (eg, muscles, central nervous system, internal organs).2

Morbidity and mortality of CUA is often due to bacterial infections and sepsis related to the necrotic tissue. CUA can be treated with sodium thiosulfate (25 g in 100 mL of normal saline) infused intravenously during the last 30 minutes of dialysis treatment 3 times per week.3 Sodium thiosulfate (which acts as a calcium binder) and cinacalcet (a calcimimetic that leads to lower parathyroid hormone levels) have been used, but evidence of efficacy is limited. In a multicenter observational study involving 89 patients with chronic kidney disease and CUA, 17% of patients experienced complete wound healing, while 56% died over a median follow-up period of 5.8 months.1 (No cause of death data were available; sodium thiosulfate and a calcimimetic were the most widely used treatment strategies.) This extrapolated to a mortality rate of 72 patients per 100 individuals over the course of 1 year (the 100 patient-years rate).1

This patient continued her dialysis regimen and general care. She was seen by the wound care team and treated with topical wound care, including moist dressings for her open lesions. The eschars were not debrided because they showed no sign of active infection. Unfortunately, she was in extremely frail condition and died 1 month after evaluation.

Photo and text courtesy of Daniel Stulberg, MD, FAAFP, Professor and Chair, Department of Family and Community Medicine, Western Michigan University Homer Stryker, MD School of Medicine, Kalamazoo.

Leathery plaque on thigh

The necrotic eschar on this patient’s thigh is calciphylaxis, also known as calcific uremic arteriolopathy (CUA). Most cases are seen in ESRD and start as painful erythematous, firm lesions that progress to necrotic eschars. Up to 4% of patients with ESRD who are on dialysis develop CUA.1

The exact pathology of CUA is unknown. Calcification of the arterioles leads to ischemia and necrosis of tissue, which is not limited to the skin and can affect tissue elsewhere (eg, muscles, central nervous system, internal organs).2

Morbidity and mortality of CUA is often due to bacterial infections and sepsis related to the necrotic tissue. CUA can be treated with sodium thiosulfate (25 g in 100 mL of normal saline) infused intravenously during the last 30 minutes of dialysis treatment 3 times per week.3 Sodium thiosulfate (which acts as a calcium binder) and cinacalcet (a calcimimetic that leads to lower parathyroid hormone levels) have been used, but evidence of efficacy is limited. In a multicenter observational study involving 89 patients with chronic kidney disease and CUA, 17% of patients experienced complete wound healing, while 56% died over a median follow-up period of 5.8 months.1 (No cause of death data were available; sodium thiosulfate and a calcimimetic were the most widely used treatment strategies.) This extrapolated to a mortality rate of 72 patients per 100 individuals over the course of 1 year (the 100 patient-years rate).1

This patient continued her dialysis regimen and general care. She was seen by the wound care team and treated with topical wound care, including moist dressings for her open lesions. The eschars were not debrided because they showed no sign of active infection. Unfortunately, she was in extremely frail condition and died 1 month after evaluation.

Photo and text courtesy of Daniel Stulberg, MD, FAAFP, Professor and Chair, Department of Family and Community Medicine, Western Michigan University Homer Stryker, MD School of Medicine, Kalamazoo.

References

1. Chinnadurai R, Huckle A, Hegarty J, et al. Calciphylaxis in end-stage kidney disease: outcome data from the United Kingdom Calciphylaxis Study. J Nephrol. 2021;34:1537-1545. doi: 10.1007/s40620-020-00908-9

2. Nigwekar SU, Kroshinsky D, Nazarian RM, et al. Calciphylaxis: risk factors, diagnosis, and treatment. Am J Kidney Dis. 2015;66:133-146. doi: 10.1053/j.ajkd.2015.01.034

3. Nigwekar SU, Kroshinsky D, Nazarian RM, et al. Calciphylaxis: risk factors, diagnosis, and treatment. Am J Kidney Dis. 2015;66:133-146. doi: 10.1053/j.ajkd.2015.01.034

References

1. Chinnadurai R, Huckle A, Hegarty J, et al. Calciphylaxis in end-stage kidney disease: outcome data from the United Kingdom Calciphylaxis Study. J Nephrol. 2021;34:1537-1545. doi: 10.1007/s40620-020-00908-9

2. Nigwekar SU, Kroshinsky D, Nazarian RM, et al. Calciphylaxis: risk factors, diagnosis, and treatment. Am J Kidney Dis. 2015;66:133-146. doi: 10.1053/j.ajkd.2015.01.034

3. Nigwekar SU, Kroshinsky D, Nazarian RM, et al. Calciphylaxis: risk factors, diagnosis, and treatment. Am J Kidney Dis. 2015;66:133-146. doi: 10.1053/j.ajkd.2015.01.034

Issue
The Journal of Family Practice - 72(6)
Issue
The Journal of Family Practice - 72(6)
Publications
Publications
Topics
Article Type
Display Headline
Leathery plaque on thigh
Display Headline
Leathery plaque on thigh
Sections
Disallow All Ads
Content Gating
No Gating (article Unlocked/Free)
Alternative CME
Disqus Comments
Default
Gate On Date
Tue, 08/15/2023 - 06:30
Un-Gate On Date
Tue, 08/15/2023 - 06:30
Use ProPublica
CFC Schedule Remove Status
Tue, 08/15/2023 - 06:30
Hide sidebar & use full width
render the right sidebar.
Conference Recap Checkbox
Not Conference Recap
Clinical Edge
Display the Slideshow in this Article
Medscape Article
Display survey writer
Reuters content
Disable Inline Native ads
WebMD Article