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‘I think I’m transgender’: A clinician’s guide to next steps
A 16-year-old patient sits in front of you and says, “I think I’m transgender.”
What do you do?
Whether you are an endocrinologist, family physician, pediatrician, or emergency physician, it’s probably a situation for which medical school education did not sufficiently prepare you. What you know is that you want to do your best to guide your patient and offer every resource necessary for a healthy and happy life. The good news is that your patient trusted you enough to disclose this information to you.
Sadly, this isn’t always the case. About 23% of transgender adults responding to the 2015 U.S. Transgender Survey put off necessary health care because they fear being mistreated or disrespected. Nearly one-third (31%) of survey respondents reported that none of their health care providers knew they were transgender.
Now that your patient feels comfortable enough with you to share this information, you must make sure you do everything in your power to continue to earn your patient’s trust.
Language matters
First, make sure that you are respectful with your terminology. Ask the patient for their name, pronouns, and gender identity. For example: “My name is Dr. Pine, and my pronouns are she/her. What are your pronouns? How do you describe your gender identity?” Each person may have terminology that is specific to their own experience, so allowing people to use their own language is the most respectful method.
People may identify as male, female, transwoman, transman, gender fluid, nonbinary, agender, neutrois, pangender, two-spirit, or other options not listed here. Physicians can be supportive by ensuring that their paperwork or electronic medical systems are sensitive to the needs of the transgender community. Having an option for the patient’s chosen name is courteous to all patients, regardless of gender identity; not everyone uses their legal name in everyday conversation.
Paperwork and electronic medical systems should ask for gender identity and sex assigned at birth, allow write-in options for issues of gender and sexual orientation, and ask for an anatomical inventory or organ inventory so that cancer screening can be conducted for the appropriate body parts.
Questions to ask
Ask patients about their gender journey: How long have they felt this way? How did they come to understand themselves and their gender? When did they start to disclose their experience with others? With pediatric patients, I ask if they have discussed this with their parents/guardians, and if they would like to have that conversation together.
Ask how you can support the patient on their journey. Are they interested in therapy, puberty blockers, hormones, or surgery? People may seek therapy for help coping with internalized transphobia, family rejection, or stigma. They may also want information or support with accessing hormones or surgery. In addition to individual therapy, there are numerous support groups for children, individuals, parents/guardians, and partners, such as PFLAG.org and Genderspectrum.org.
If you are the right kind of doctor and ready to prescribe, you can begin counseling. If not, you should know how to find local resources. The World Professional Association for Transgender Health has a directory of providers, and there are other resources listed below.
What does gender transitioning entail?
There are many components to gender transition. Some transitions may consist primarily of a social transition, with people using a different name, pronouns, and external expression, such as hairstyle and clothing. For others, there may be a medical component.
Mental health care is also an important component of gender transition for children, adolescents, adults, and family members. Mental health concerns are significantly greater in transgender and gender-nonconforming people, with higher rates of depression, anxiety, suicidal ideation, self-harm, substance abuse, eating disorders, and neurodiversity on the autism spectrum. In a study of more than 6,400 transgender people in the United States, 41% reported attempting suicide – a rate 25 times higher than that of the general population. Numerous studies show that hormonal treatment decreases depression, suicidal ideation, and anxiety, and also improves quality of life.
One common misperception, especially when working with children, is that youth transition involves a “sex change” (an outdated term) or any type of surgery. In reality, the main intervention before puberty is psychological support and social transition. The use of a chosen name at school, home, work, and with friends was shown to be associated with lower depression, suicidal ideation, and suicidal behavior. Another study demonstrated that children supported in their identities have mental health similar to that of cisgender siblings and peers.
When puberty approaches, if there is distress around natal pubertal development, then gonadotropin-releasing hormone agonists or “puberty blockers” may be used to temporarily pause the pubertal process, but only after Tanner stage II-III is reached. These medications have been safely used for decades for patients with central precocious puberty. Access to puberty-blocking medication in adolescence (when desired) has been associated with lower rates of suicidal ideation in adulthood and can truly be a lifesaving intervention.
When teens are older, they may choose to take gender-affirming hormone therapy to go through the puberty that is concordant with their affirmed gender. Adults who decide to transition medically may decide to take hormone therapy and may have gender-confirmation surgery, if desired, to align the body with their gender identity and alleviate gender dysphoria. Overall, access to medical care and hormone therapy have been shown to decrease depression, anxiety, and suicidality, and improve quality of life.
Sexuality and fertility
It is important to understand that sexuality is separate from gender identity, and that attraction and sexual activity cannot be assumed. Take a sensitive romantic and sexual history from your patient to get the information necessary to counsel patients about safe relationships and sexual practices. It is important not to make assumptions; a patient who is asexual may still be having sex, and a transgender man may be having receptive vaginal intercourse and may need information about contraception and family planning.
Also, be careful about using clinical language. Some people may want to use anatomical terms, but others may be uncomfortable or triggered by them. For instance, a transgender man may use “chest” for breasts, or “genital canal,” and “junk,” “dick,” or “front hole” for the vagina. Ask patients what terms they prefer to use.
It is also important to consider the impact that medical and surgical interventions may have on fertility, especially when discussing the topic with children and adolescents who may not have spent much time thinking about family planning. Be careful not to make assumptions about plans for parenthood, and remember that there are many paths to becoming a parent.
What does the patient need right now?
When I was a fourth-year medical student on my outpatient child psychiatry rotation, a 5-year-old child assigned male at birth was guarded and frightened of me until their mother said: “It’s okay, Dr. Elyse likes girl things too,” at which point the child became animated and happy while chatting with me about Barbie dolls. My patient had already endured teasing about gender nonconformity, starting in kindergarten; it was unclear to my patient whether I would be a safe person or a bully.
The mother was kind and affirming, but she also wanted answers. Would her child grow up to be a gay man? Or a transgender woman? Would her child be able to live freely, or would they always be quiet around others, scared of what people might say? Would her child be safe?
We can’t predict the future, but as doctors, we want to use all of our knowledge and tools to help our patients live healthy lives. In this case, it meant helping the mother know how to support her child’s identity, how to advocate for a safe school and community, where to connect with other gender-creative children, and how to tolerate ambiguity and celebrate the child she has, not the child she expected.
We know that people with higher support and higher self-esteem can have greater resilience and greater success. This family may need medical resources for puberty blockers, hormone therapy, and even surgery someday, but reassurance is what was needed in the moment. When your patient comes out to you, they are trusting you. It is your obligation and privilege as a medical professional to help them begin a journey to an authentic life.
A version of this article first appeared on Medscape.com.
A 16-year-old patient sits in front of you and says, “I think I’m transgender.”
What do you do?
Whether you are an endocrinologist, family physician, pediatrician, or emergency physician, it’s probably a situation for which medical school education did not sufficiently prepare you. What you know is that you want to do your best to guide your patient and offer every resource necessary for a healthy and happy life. The good news is that your patient trusted you enough to disclose this information to you.
Sadly, this isn’t always the case. About 23% of transgender adults responding to the 2015 U.S. Transgender Survey put off necessary health care because they fear being mistreated or disrespected. Nearly one-third (31%) of survey respondents reported that none of their health care providers knew they were transgender.
Now that your patient feels comfortable enough with you to share this information, you must make sure you do everything in your power to continue to earn your patient’s trust.
Language matters
First, make sure that you are respectful with your terminology. Ask the patient for their name, pronouns, and gender identity. For example: “My name is Dr. Pine, and my pronouns are she/her. What are your pronouns? How do you describe your gender identity?” Each person may have terminology that is specific to their own experience, so allowing people to use their own language is the most respectful method.
People may identify as male, female, transwoman, transman, gender fluid, nonbinary, agender, neutrois, pangender, two-spirit, or other options not listed here. Physicians can be supportive by ensuring that their paperwork or electronic medical systems are sensitive to the needs of the transgender community. Having an option for the patient’s chosen name is courteous to all patients, regardless of gender identity; not everyone uses their legal name in everyday conversation.
Paperwork and electronic medical systems should ask for gender identity and sex assigned at birth, allow write-in options for issues of gender and sexual orientation, and ask for an anatomical inventory or organ inventory so that cancer screening can be conducted for the appropriate body parts.
Questions to ask
Ask patients about their gender journey: How long have they felt this way? How did they come to understand themselves and their gender? When did they start to disclose their experience with others? With pediatric patients, I ask if they have discussed this with their parents/guardians, and if they would like to have that conversation together.
Ask how you can support the patient on their journey. Are they interested in therapy, puberty blockers, hormones, or surgery? People may seek therapy for help coping with internalized transphobia, family rejection, or stigma. They may also want information or support with accessing hormones or surgery. In addition to individual therapy, there are numerous support groups for children, individuals, parents/guardians, and partners, such as PFLAG.org and Genderspectrum.org.
If you are the right kind of doctor and ready to prescribe, you can begin counseling. If not, you should know how to find local resources. The World Professional Association for Transgender Health has a directory of providers, and there are other resources listed below.
What does gender transitioning entail?
There are many components to gender transition. Some transitions may consist primarily of a social transition, with people using a different name, pronouns, and external expression, such as hairstyle and clothing. For others, there may be a medical component.
Mental health care is also an important component of gender transition for children, adolescents, adults, and family members. Mental health concerns are significantly greater in transgender and gender-nonconforming people, with higher rates of depression, anxiety, suicidal ideation, self-harm, substance abuse, eating disorders, and neurodiversity on the autism spectrum. In a study of more than 6,400 transgender people in the United States, 41% reported attempting suicide – a rate 25 times higher than that of the general population. Numerous studies show that hormonal treatment decreases depression, suicidal ideation, and anxiety, and also improves quality of life.
One common misperception, especially when working with children, is that youth transition involves a “sex change” (an outdated term) or any type of surgery. In reality, the main intervention before puberty is psychological support and social transition. The use of a chosen name at school, home, work, and with friends was shown to be associated with lower depression, suicidal ideation, and suicidal behavior. Another study demonstrated that children supported in their identities have mental health similar to that of cisgender siblings and peers.
When puberty approaches, if there is distress around natal pubertal development, then gonadotropin-releasing hormone agonists or “puberty blockers” may be used to temporarily pause the pubertal process, but only after Tanner stage II-III is reached. These medications have been safely used for decades for patients with central precocious puberty. Access to puberty-blocking medication in adolescence (when desired) has been associated with lower rates of suicidal ideation in adulthood and can truly be a lifesaving intervention.
When teens are older, they may choose to take gender-affirming hormone therapy to go through the puberty that is concordant with their affirmed gender. Adults who decide to transition medically may decide to take hormone therapy and may have gender-confirmation surgery, if desired, to align the body with their gender identity and alleviate gender dysphoria. Overall, access to medical care and hormone therapy have been shown to decrease depression, anxiety, and suicidality, and improve quality of life.
Sexuality and fertility
It is important to understand that sexuality is separate from gender identity, and that attraction and sexual activity cannot be assumed. Take a sensitive romantic and sexual history from your patient to get the information necessary to counsel patients about safe relationships and sexual practices. It is important not to make assumptions; a patient who is asexual may still be having sex, and a transgender man may be having receptive vaginal intercourse and may need information about contraception and family planning.
Also, be careful about using clinical language. Some people may want to use anatomical terms, but others may be uncomfortable or triggered by them. For instance, a transgender man may use “chest” for breasts, or “genital canal,” and “junk,” “dick,” or “front hole” for the vagina. Ask patients what terms they prefer to use.
It is also important to consider the impact that medical and surgical interventions may have on fertility, especially when discussing the topic with children and adolescents who may not have spent much time thinking about family planning. Be careful not to make assumptions about plans for parenthood, and remember that there are many paths to becoming a parent.
What does the patient need right now?
When I was a fourth-year medical student on my outpatient child psychiatry rotation, a 5-year-old child assigned male at birth was guarded and frightened of me until their mother said: “It’s okay, Dr. Elyse likes girl things too,” at which point the child became animated and happy while chatting with me about Barbie dolls. My patient had already endured teasing about gender nonconformity, starting in kindergarten; it was unclear to my patient whether I would be a safe person or a bully.
The mother was kind and affirming, but she also wanted answers. Would her child grow up to be a gay man? Or a transgender woman? Would her child be able to live freely, or would they always be quiet around others, scared of what people might say? Would her child be safe?
We can’t predict the future, but as doctors, we want to use all of our knowledge and tools to help our patients live healthy lives. In this case, it meant helping the mother know how to support her child’s identity, how to advocate for a safe school and community, where to connect with other gender-creative children, and how to tolerate ambiguity and celebrate the child she has, not the child she expected.
We know that people with higher support and higher self-esteem can have greater resilience and greater success. This family may need medical resources for puberty blockers, hormone therapy, and even surgery someday, but reassurance is what was needed in the moment. When your patient comes out to you, they are trusting you. It is your obligation and privilege as a medical professional to help them begin a journey to an authentic life.
A version of this article first appeared on Medscape.com.
A 16-year-old patient sits in front of you and says, “I think I’m transgender.”
What do you do?
Whether you are an endocrinologist, family physician, pediatrician, or emergency physician, it’s probably a situation for which medical school education did not sufficiently prepare you. What you know is that you want to do your best to guide your patient and offer every resource necessary for a healthy and happy life. The good news is that your patient trusted you enough to disclose this information to you.
Sadly, this isn’t always the case. About 23% of transgender adults responding to the 2015 U.S. Transgender Survey put off necessary health care because they fear being mistreated or disrespected. Nearly one-third (31%) of survey respondents reported that none of their health care providers knew they were transgender.
Now that your patient feels comfortable enough with you to share this information, you must make sure you do everything in your power to continue to earn your patient’s trust.
Language matters
First, make sure that you are respectful with your terminology. Ask the patient for their name, pronouns, and gender identity. For example: “My name is Dr. Pine, and my pronouns are she/her. What are your pronouns? How do you describe your gender identity?” Each person may have terminology that is specific to their own experience, so allowing people to use their own language is the most respectful method.
People may identify as male, female, transwoman, transman, gender fluid, nonbinary, agender, neutrois, pangender, two-spirit, or other options not listed here. Physicians can be supportive by ensuring that their paperwork or electronic medical systems are sensitive to the needs of the transgender community. Having an option for the patient’s chosen name is courteous to all patients, regardless of gender identity; not everyone uses their legal name in everyday conversation.
Paperwork and electronic medical systems should ask for gender identity and sex assigned at birth, allow write-in options for issues of gender and sexual orientation, and ask for an anatomical inventory or organ inventory so that cancer screening can be conducted for the appropriate body parts.
Questions to ask
Ask patients about their gender journey: How long have they felt this way? How did they come to understand themselves and their gender? When did they start to disclose their experience with others? With pediatric patients, I ask if they have discussed this with their parents/guardians, and if they would like to have that conversation together.
Ask how you can support the patient on their journey. Are they interested in therapy, puberty blockers, hormones, or surgery? People may seek therapy for help coping with internalized transphobia, family rejection, or stigma. They may also want information or support with accessing hormones or surgery. In addition to individual therapy, there are numerous support groups for children, individuals, parents/guardians, and partners, such as PFLAG.org and Genderspectrum.org.
If you are the right kind of doctor and ready to prescribe, you can begin counseling. If not, you should know how to find local resources. The World Professional Association for Transgender Health has a directory of providers, and there are other resources listed below.
What does gender transitioning entail?
There are many components to gender transition. Some transitions may consist primarily of a social transition, with people using a different name, pronouns, and external expression, such as hairstyle and clothing. For others, there may be a medical component.
Mental health care is also an important component of gender transition for children, adolescents, adults, and family members. Mental health concerns are significantly greater in transgender and gender-nonconforming people, with higher rates of depression, anxiety, suicidal ideation, self-harm, substance abuse, eating disorders, and neurodiversity on the autism spectrum. In a study of more than 6,400 transgender people in the United States, 41% reported attempting suicide – a rate 25 times higher than that of the general population. Numerous studies show that hormonal treatment decreases depression, suicidal ideation, and anxiety, and also improves quality of life.
One common misperception, especially when working with children, is that youth transition involves a “sex change” (an outdated term) or any type of surgery. In reality, the main intervention before puberty is psychological support and social transition. The use of a chosen name at school, home, work, and with friends was shown to be associated with lower depression, suicidal ideation, and suicidal behavior. Another study demonstrated that children supported in their identities have mental health similar to that of cisgender siblings and peers.
When puberty approaches, if there is distress around natal pubertal development, then gonadotropin-releasing hormone agonists or “puberty blockers” may be used to temporarily pause the pubertal process, but only after Tanner stage II-III is reached. These medications have been safely used for decades for patients with central precocious puberty. Access to puberty-blocking medication in adolescence (when desired) has been associated with lower rates of suicidal ideation in adulthood and can truly be a lifesaving intervention.
When teens are older, they may choose to take gender-affirming hormone therapy to go through the puberty that is concordant with their affirmed gender. Adults who decide to transition medically may decide to take hormone therapy and may have gender-confirmation surgery, if desired, to align the body with their gender identity and alleviate gender dysphoria. Overall, access to medical care and hormone therapy have been shown to decrease depression, anxiety, and suicidality, and improve quality of life.
Sexuality and fertility
It is important to understand that sexuality is separate from gender identity, and that attraction and sexual activity cannot be assumed. Take a sensitive romantic and sexual history from your patient to get the information necessary to counsel patients about safe relationships and sexual practices. It is important not to make assumptions; a patient who is asexual may still be having sex, and a transgender man may be having receptive vaginal intercourse and may need information about contraception and family planning.
Also, be careful about using clinical language. Some people may want to use anatomical terms, but others may be uncomfortable or triggered by them. For instance, a transgender man may use “chest” for breasts, or “genital canal,” and “junk,” “dick,” or “front hole” for the vagina. Ask patients what terms they prefer to use.
It is also important to consider the impact that medical and surgical interventions may have on fertility, especially when discussing the topic with children and adolescents who may not have spent much time thinking about family planning. Be careful not to make assumptions about plans for parenthood, and remember that there are many paths to becoming a parent.
What does the patient need right now?
When I was a fourth-year medical student on my outpatient child psychiatry rotation, a 5-year-old child assigned male at birth was guarded and frightened of me until their mother said: “It’s okay, Dr. Elyse likes girl things too,” at which point the child became animated and happy while chatting with me about Barbie dolls. My patient had already endured teasing about gender nonconformity, starting in kindergarten; it was unclear to my patient whether I would be a safe person or a bully.
The mother was kind and affirming, but she also wanted answers. Would her child grow up to be a gay man? Or a transgender woman? Would her child be able to live freely, or would they always be quiet around others, scared of what people might say? Would her child be safe?
We can’t predict the future, but as doctors, we want to use all of our knowledge and tools to help our patients live healthy lives. In this case, it meant helping the mother know how to support her child’s identity, how to advocate for a safe school and community, where to connect with other gender-creative children, and how to tolerate ambiguity and celebrate the child she has, not the child she expected.
We know that people with higher support and higher self-esteem can have greater resilience and greater success. This family may need medical resources for puberty blockers, hormone therapy, and even surgery someday, but reassurance is what was needed in the moment. When your patient comes out to you, they are trusting you. It is your obligation and privilege as a medical professional to help them begin a journey to an authentic life.
A version of this article first appeared on Medscape.com.
AGA Clinical Practice Update: Eradication strategies for H. pylori infection
Antimicrobial resistance is the most common cause of treatment-refractory Helicobacter pylori infection, but before switching antibiotics, clinicians should screen for factors such as treatment nonadherence or inadequate suppression of gastric acid, according to a clinical practice update from the American Gastroenterological Association.
“Inadequate acid suppression is associated with H. pylori eradication failure. The use of high-dose and more potent PPIs, PPIs not metabolized by CYP2C19, or potassium-competitive acid blockers, if available, should be considered in cases of refractory H. pylori infection,” wrote Shailja C. Shah, MD, MPH, of Vanderbilt University Medical Center in Nashville, Tenn., and coauthors Prasad G. Iyer, MD, and Steven F. Moss, MD. . Their report is in Gastroenterology.
H. pylori infection is the most common cause of gastric cancer. Although eradication is widely recommended, it can be challenging because of strain diversity, rising antimicrobial resistance, a dearth of recent head-to-head clinical trials, and sparse epidemiologic and sensitivity data, the experts noted. For this reason, before selecting an eradication regimen, it is vital to thoroughly review a patient’s history of antibiotics – for example, any prior macrolide or fluoroquinolone exposure should preclude the use of clarithromycin- or levofloxacin-based regimens “given the high likelihood of resistance,” the experts wrote. They also advised that clinicians should avoid levofloxacin unless the H. pylori strain is known to be sensitive to it or if population rates of levofloxacin resistance rates are known to be less than 15%. However, amoxicillin, tetracycline, and rifabutin resistance are rare, and these agents “can be considered for subsequent therapies in refractory H. pylori infection.”
A longer antimicrobial regimen (such as 14 vs. 7 days) is more likely to eradicate H. pylori. If first-line bismuth quadruple therapy (such as a PPI plus bismuth, metronidazole, and tetracycline) fails, then second-line options include another bismuth-containing quadruple-agent regimen, or triple therapy with rifabutin or levofloxacin plus high-dose dual PPI therapy and amoxicillin. If patient history contains “penicillin allergy” but does not list anaphylaxis, then penicillin allergy testing can help determine if amoxicillin-based regimens are an option. The authors also note that, when used, amoxicillin should be dosed at 2 g/day in divided doses three to four times per day in order to avoid low trough levels because this might be associated with H. pylori eradication failure. For metronidazole, regardless of in vitro resistance, eradication is more likely if patients receive 1.5-2 g/day, in divided doses, with concomitant bismuth.
Treatment nonadherence contributes to refractory H. pylori infection and may be caused by the complexity of the treatment regimen, high pill burden, and side effects. To improve adherence, the experts advised counseling patients on the rationale for the treatment regimen, the dosing instructions, the importance of completing the full course of therapy, and providing anticipatory guidance regarding common side effects. If a patient adheres to second-line treatment and it still fails, then susceptibility testing is advised before starting another regimen. Depending on the results, options may include levofloxacin-based quadruple therapy, another round of bismuth-based quadruple therapy, a PPI plus amoxicillin and rifabutin, or high-dose PPI therapy plus high-dose amoxicillin (2-3 g/day divided across three to four doses).
Other considerations include how to approach patients and caregivers, particularly the elderly and other vulnerable patients, with shared decision-making to help them weigh the potential benefits of continuing to try to eradicate H. pylori against the risk of possible adverse effects and the “inconvenience of repeated exposure to antibiotics and high-dose acid suppression,” the experts wrote. They also advised tracking rates of eradication success and relevant demographic and clinical data, including patients’ antibiotic history. Publicly sharing aggregated, deidentified results can help other local clinicians select eradication regimens. Finally, the use of probiotics and other adjunctive therapies “should be considered experimental” since these have no clear benefit for treating refractory H. pylori infection.
Dr. Shah was funded by an AGA Research Scholar Award and a Veterans Affairs Career Development Award. She reported having no conflicts of interest. Dr. Iyer and Dr. Moss disclosed ties to Exact Sciences, Pentax Medical, Redhill Biopharma, Phathom, American Molecular Laboratories, and Takeda.
Antimicrobial resistance is the most common cause of treatment-refractory Helicobacter pylori infection, but before switching antibiotics, clinicians should screen for factors such as treatment nonadherence or inadequate suppression of gastric acid, according to a clinical practice update from the American Gastroenterological Association.
“Inadequate acid suppression is associated with H. pylori eradication failure. The use of high-dose and more potent PPIs, PPIs not metabolized by CYP2C19, or potassium-competitive acid blockers, if available, should be considered in cases of refractory H. pylori infection,” wrote Shailja C. Shah, MD, MPH, of Vanderbilt University Medical Center in Nashville, Tenn., and coauthors Prasad G. Iyer, MD, and Steven F. Moss, MD. . Their report is in Gastroenterology.
H. pylori infection is the most common cause of gastric cancer. Although eradication is widely recommended, it can be challenging because of strain diversity, rising antimicrobial resistance, a dearth of recent head-to-head clinical trials, and sparse epidemiologic and sensitivity data, the experts noted. For this reason, before selecting an eradication regimen, it is vital to thoroughly review a patient’s history of antibiotics – for example, any prior macrolide or fluoroquinolone exposure should preclude the use of clarithromycin- or levofloxacin-based regimens “given the high likelihood of resistance,” the experts wrote. They also advised that clinicians should avoid levofloxacin unless the H. pylori strain is known to be sensitive to it or if population rates of levofloxacin resistance rates are known to be less than 15%. However, amoxicillin, tetracycline, and rifabutin resistance are rare, and these agents “can be considered for subsequent therapies in refractory H. pylori infection.”
A longer antimicrobial regimen (such as 14 vs. 7 days) is more likely to eradicate H. pylori. If first-line bismuth quadruple therapy (such as a PPI plus bismuth, metronidazole, and tetracycline) fails, then second-line options include another bismuth-containing quadruple-agent regimen, or triple therapy with rifabutin or levofloxacin plus high-dose dual PPI therapy and amoxicillin. If patient history contains “penicillin allergy” but does not list anaphylaxis, then penicillin allergy testing can help determine if amoxicillin-based regimens are an option. The authors also note that, when used, amoxicillin should be dosed at 2 g/day in divided doses three to four times per day in order to avoid low trough levels because this might be associated with H. pylori eradication failure. For metronidazole, regardless of in vitro resistance, eradication is more likely if patients receive 1.5-2 g/day, in divided doses, with concomitant bismuth.
Treatment nonadherence contributes to refractory H. pylori infection and may be caused by the complexity of the treatment regimen, high pill burden, and side effects. To improve adherence, the experts advised counseling patients on the rationale for the treatment regimen, the dosing instructions, the importance of completing the full course of therapy, and providing anticipatory guidance regarding common side effects. If a patient adheres to second-line treatment and it still fails, then susceptibility testing is advised before starting another regimen. Depending on the results, options may include levofloxacin-based quadruple therapy, another round of bismuth-based quadruple therapy, a PPI plus amoxicillin and rifabutin, or high-dose PPI therapy plus high-dose amoxicillin (2-3 g/day divided across three to four doses).
Other considerations include how to approach patients and caregivers, particularly the elderly and other vulnerable patients, with shared decision-making to help them weigh the potential benefits of continuing to try to eradicate H. pylori against the risk of possible adverse effects and the “inconvenience of repeated exposure to antibiotics and high-dose acid suppression,” the experts wrote. They also advised tracking rates of eradication success and relevant demographic and clinical data, including patients’ antibiotic history. Publicly sharing aggregated, deidentified results can help other local clinicians select eradication regimens. Finally, the use of probiotics and other adjunctive therapies “should be considered experimental” since these have no clear benefit for treating refractory H. pylori infection.
Dr. Shah was funded by an AGA Research Scholar Award and a Veterans Affairs Career Development Award. She reported having no conflicts of interest. Dr. Iyer and Dr. Moss disclosed ties to Exact Sciences, Pentax Medical, Redhill Biopharma, Phathom, American Molecular Laboratories, and Takeda.
Antimicrobial resistance is the most common cause of treatment-refractory Helicobacter pylori infection, but before switching antibiotics, clinicians should screen for factors such as treatment nonadherence or inadequate suppression of gastric acid, according to a clinical practice update from the American Gastroenterological Association.
“Inadequate acid suppression is associated with H. pylori eradication failure. The use of high-dose and more potent PPIs, PPIs not metabolized by CYP2C19, or potassium-competitive acid blockers, if available, should be considered in cases of refractory H. pylori infection,” wrote Shailja C. Shah, MD, MPH, of Vanderbilt University Medical Center in Nashville, Tenn., and coauthors Prasad G. Iyer, MD, and Steven F. Moss, MD. . Their report is in Gastroenterology.
H. pylori infection is the most common cause of gastric cancer. Although eradication is widely recommended, it can be challenging because of strain diversity, rising antimicrobial resistance, a dearth of recent head-to-head clinical trials, and sparse epidemiologic and sensitivity data, the experts noted. For this reason, before selecting an eradication regimen, it is vital to thoroughly review a patient’s history of antibiotics – for example, any prior macrolide or fluoroquinolone exposure should preclude the use of clarithromycin- or levofloxacin-based regimens “given the high likelihood of resistance,” the experts wrote. They also advised that clinicians should avoid levofloxacin unless the H. pylori strain is known to be sensitive to it or if population rates of levofloxacin resistance rates are known to be less than 15%. However, amoxicillin, tetracycline, and rifabutin resistance are rare, and these agents “can be considered for subsequent therapies in refractory H. pylori infection.”
A longer antimicrobial regimen (such as 14 vs. 7 days) is more likely to eradicate H. pylori. If first-line bismuth quadruple therapy (such as a PPI plus bismuth, metronidazole, and tetracycline) fails, then second-line options include another bismuth-containing quadruple-agent regimen, or triple therapy with rifabutin or levofloxacin plus high-dose dual PPI therapy and amoxicillin. If patient history contains “penicillin allergy” but does not list anaphylaxis, then penicillin allergy testing can help determine if amoxicillin-based regimens are an option. The authors also note that, when used, amoxicillin should be dosed at 2 g/day in divided doses three to four times per day in order to avoid low trough levels because this might be associated with H. pylori eradication failure. For metronidazole, regardless of in vitro resistance, eradication is more likely if patients receive 1.5-2 g/day, in divided doses, with concomitant bismuth.
Treatment nonadherence contributes to refractory H. pylori infection and may be caused by the complexity of the treatment regimen, high pill burden, and side effects. To improve adherence, the experts advised counseling patients on the rationale for the treatment regimen, the dosing instructions, the importance of completing the full course of therapy, and providing anticipatory guidance regarding common side effects. If a patient adheres to second-line treatment and it still fails, then susceptibility testing is advised before starting another regimen. Depending on the results, options may include levofloxacin-based quadruple therapy, another round of bismuth-based quadruple therapy, a PPI plus amoxicillin and rifabutin, or high-dose PPI therapy plus high-dose amoxicillin (2-3 g/day divided across three to four doses).
Other considerations include how to approach patients and caregivers, particularly the elderly and other vulnerable patients, with shared decision-making to help them weigh the potential benefits of continuing to try to eradicate H. pylori against the risk of possible adverse effects and the “inconvenience of repeated exposure to antibiotics and high-dose acid suppression,” the experts wrote. They also advised tracking rates of eradication success and relevant demographic and clinical data, including patients’ antibiotic history. Publicly sharing aggregated, deidentified results can help other local clinicians select eradication regimens. Finally, the use of probiotics and other adjunctive therapies “should be considered experimental” since these have no clear benefit for treating refractory H. pylori infection.
Dr. Shah was funded by an AGA Research Scholar Award and a Veterans Affairs Career Development Award. She reported having no conflicts of interest. Dr. Iyer and Dr. Moss disclosed ties to Exact Sciences, Pentax Medical, Redhill Biopharma, Phathom, American Molecular Laboratories, and Takeda.
FROM GASTROENTEROLOGY
Novel agent shows promise against cat allergy
One dose of the novel agent, REGN1908-1909 (Regeneron Pharmaceuticals) resulted in a rapid and durable reduction in cat-allergen-induced bronchoconstriction in cat-allergic subjects with mild asthma.
The finding, from a phase 2 randomized placebo-controlled study, is good news for the millions of people who are plagued by cat allergies, the investigators say.
The study, which was sponsored by Regeneron, was presented in a late breaking oral abstract session at the annual meeting of the American Academy of Allergy, Asthma, and Immunology, held virtually this year.
“REGN1908-1909 contains antibodies against Fel d 1, the major cat allergen, and here we show that it quickly and lastingly reduces acute bronchoconstriction in people with cat allergy,” lead author Frederic J. de Blay, MD, Strasbourg University Hospital, France, said in an interview.
Dr. de Blay admitted he is “quite excited” about the results.
“This study was performed in an environmental exposure chamber, and we clearly demonstrate that these antibodies decrease the asthmatic response to cat allergen within 8 days, and that these effects last 3 months. I never saw that in my life. I was a little bit skeptical at first, so to obtain such robust results after just 8 days, after just one injection, I was very surprised,” he said.
Dr. de Blay and his team screened potential participants to make sure they were cat allergic by exposing them to cat allergen for up to 2 hours while they were in the environmental exposure chamber. To be eligible for the study, participants had to show an early asthmatic response (EAR), defined as a reduction in forced expiratory volume in 1 second (FEV1) of at least 20% from baseline.
The participants were then randomized to receive either single-dose REGN1908-1909, 600 mg, subcutaneously (n = 29 patients) or placebo (n = 27 patients) prior to cat-allergen exposure in the controlled environmental chamber.
Dr. de Blay developed the chamber used in the study: the ALYATEC environmental exposure chamber.
“The chamber is 60 meters square, or 150 cubic meters, and can accommodate 20 patients. We are able to nebulize cat allergen, mice allergen, or whatever we wish to study so we can standardize the exposure. We can control the particle size and the amount so we know the exact amount of allergen that the patient has been exposed to,” he explained.
To test the efficacy of REGN1908-1909 in reducing acute bronchoconstriction, or EAR, the researchers measured FEV1 at baseline, and on days 8, 29, 57, and 85 in both groups. During each exposure, measurements were taken every 10 minutes for periods that lasted up to 4 hours.
They found that the probability of remaining in the chamber with no asthmatic response was substantially elevated in the group treated with REGN1908-1909.
Compared with placebo, REGN1908-1909 significantly increased the median time to EAR, from 51 minutes at baseline to more than 4 hours on day 8, (hazard ratio [HR], 0.36; P < .0083), day 29 (HR, 0.24; P < .0001), day 57 (HR, 0.45; P = .0222), and day 85 (HR, 0.27; P = .0003).
The FEV1 area under the curve (AUC) was also better with REGN1908-1909 than with placebo at day 8 (15.2% vs. 1.6%; P < .001). And a single dose reduced skin-test reactivity to cat allergen at 1 week, which persisted for up to 4 months.
In addition, participants who received REGN1908-1909 were able to tolerate a threefold higher amount of the cat allergen than those who received placebo (P = .003).
“We initially gave 40 nanograms of cat allergen, and then 8 days later they were able to stay longer in the chamber and inhale more of the allergen, to almost triple the amount they had originally been given. That 40 nanograms is very close to real world exposure,” Dr. de Blay noted.
Regeneron plans to start a phase 3 trial soon, he reported.
Promising results
“The study is well designed and shows a reduction in drop of FEV1 in response to cat allergen provocation and a decreased AUC in cat SPT response over 4 months,” Jonathan A. Bernstein, MD, professor of medicine at the University of Cincinnati, said in an interview.
“These are very promising results, which show that REGN1908-1909 can be a novel treatment for cat-induced asthma, which is often the only sensitization patients have. And they love their cats – one-third of the U.S. population has a cat and one-third has a dog, and 50% have both,” noted Dr. Bernstein, who was not involved with the study.
“This novel study used our scientific knowledge of the cat allergen itself to design a targeted antibody-based treatment that demonstrates significant benefit even after the first shot,” added Edwin H. Kim, MD, director of the UNC Food Allergy Initiative at the University of North Carolina at Chapel Hill.
“This strategy has the potential to revolutionize not only our treatment of common environmental allergies but also other allergic diseases with well-described triggers, such as food and drug allergy,” Dr. Kim, who was not part of the study, said in an interview.
Dr. de Blay reported a financial relationship with Regeneron Pharmaceuticals, which sponsored the study. Dr. Bernstein and Dr. Kim have disclosed no relevant financial relationships.
A version of this article first appeared on Medscape.com.
One dose of the novel agent, REGN1908-1909 (Regeneron Pharmaceuticals) resulted in a rapid and durable reduction in cat-allergen-induced bronchoconstriction in cat-allergic subjects with mild asthma.
The finding, from a phase 2 randomized placebo-controlled study, is good news for the millions of people who are plagued by cat allergies, the investigators say.
The study, which was sponsored by Regeneron, was presented in a late breaking oral abstract session at the annual meeting of the American Academy of Allergy, Asthma, and Immunology, held virtually this year.
“REGN1908-1909 contains antibodies against Fel d 1, the major cat allergen, and here we show that it quickly and lastingly reduces acute bronchoconstriction in people with cat allergy,” lead author Frederic J. de Blay, MD, Strasbourg University Hospital, France, said in an interview.
Dr. de Blay admitted he is “quite excited” about the results.
“This study was performed in an environmental exposure chamber, and we clearly demonstrate that these antibodies decrease the asthmatic response to cat allergen within 8 days, and that these effects last 3 months. I never saw that in my life. I was a little bit skeptical at first, so to obtain such robust results after just 8 days, after just one injection, I was very surprised,” he said.
Dr. de Blay and his team screened potential participants to make sure they were cat allergic by exposing them to cat allergen for up to 2 hours while they were in the environmental exposure chamber. To be eligible for the study, participants had to show an early asthmatic response (EAR), defined as a reduction in forced expiratory volume in 1 second (FEV1) of at least 20% from baseline.
The participants were then randomized to receive either single-dose REGN1908-1909, 600 mg, subcutaneously (n = 29 patients) or placebo (n = 27 patients) prior to cat-allergen exposure in the controlled environmental chamber.
Dr. de Blay developed the chamber used in the study: the ALYATEC environmental exposure chamber.
“The chamber is 60 meters square, or 150 cubic meters, and can accommodate 20 patients. We are able to nebulize cat allergen, mice allergen, or whatever we wish to study so we can standardize the exposure. We can control the particle size and the amount so we know the exact amount of allergen that the patient has been exposed to,” he explained.
To test the efficacy of REGN1908-1909 in reducing acute bronchoconstriction, or EAR, the researchers measured FEV1 at baseline, and on days 8, 29, 57, and 85 in both groups. During each exposure, measurements were taken every 10 minutes for periods that lasted up to 4 hours.
They found that the probability of remaining in the chamber with no asthmatic response was substantially elevated in the group treated with REGN1908-1909.
Compared with placebo, REGN1908-1909 significantly increased the median time to EAR, from 51 minutes at baseline to more than 4 hours on day 8, (hazard ratio [HR], 0.36; P < .0083), day 29 (HR, 0.24; P < .0001), day 57 (HR, 0.45; P = .0222), and day 85 (HR, 0.27; P = .0003).
The FEV1 area under the curve (AUC) was also better with REGN1908-1909 than with placebo at day 8 (15.2% vs. 1.6%; P < .001). And a single dose reduced skin-test reactivity to cat allergen at 1 week, which persisted for up to 4 months.
In addition, participants who received REGN1908-1909 were able to tolerate a threefold higher amount of the cat allergen than those who received placebo (P = .003).
“We initially gave 40 nanograms of cat allergen, and then 8 days later they were able to stay longer in the chamber and inhale more of the allergen, to almost triple the amount they had originally been given. That 40 nanograms is very close to real world exposure,” Dr. de Blay noted.
Regeneron plans to start a phase 3 trial soon, he reported.
Promising results
“The study is well designed and shows a reduction in drop of FEV1 in response to cat allergen provocation and a decreased AUC in cat SPT response over 4 months,” Jonathan A. Bernstein, MD, professor of medicine at the University of Cincinnati, said in an interview.
“These are very promising results, which show that REGN1908-1909 can be a novel treatment for cat-induced asthma, which is often the only sensitization patients have. And they love their cats – one-third of the U.S. population has a cat and one-third has a dog, and 50% have both,” noted Dr. Bernstein, who was not involved with the study.
“This novel study used our scientific knowledge of the cat allergen itself to design a targeted antibody-based treatment that demonstrates significant benefit even after the first shot,” added Edwin H. Kim, MD, director of the UNC Food Allergy Initiative at the University of North Carolina at Chapel Hill.
“This strategy has the potential to revolutionize not only our treatment of common environmental allergies but also other allergic diseases with well-described triggers, such as food and drug allergy,” Dr. Kim, who was not part of the study, said in an interview.
Dr. de Blay reported a financial relationship with Regeneron Pharmaceuticals, which sponsored the study. Dr. Bernstein and Dr. Kim have disclosed no relevant financial relationships.
A version of this article first appeared on Medscape.com.
One dose of the novel agent, REGN1908-1909 (Regeneron Pharmaceuticals) resulted in a rapid and durable reduction in cat-allergen-induced bronchoconstriction in cat-allergic subjects with mild asthma.
The finding, from a phase 2 randomized placebo-controlled study, is good news for the millions of people who are plagued by cat allergies, the investigators say.
The study, which was sponsored by Regeneron, was presented in a late breaking oral abstract session at the annual meeting of the American Academy of Allergy, Asthma, and Immunology, held virtually this year.
“REGN1908-1909 contains antibodies against Fel d 1, the major cat allergen, and here we show that it quickly and lastingly reduces acute bronchoconstriction in people with cat allergy,” lead author Frederic J. de Blay, MD, Strasbourg University Hospital, France, said in an interview.
Dr. de Blay admitted he is “quite excited” about the results.
“This study was performed in an environmental exposure chamber, and we clearly demonstrate that these antibodies decrease the asthmatic response to cat allergen within 8 days, and that these effects last 3 months. I never saw that in my life. I was a little bit skeptical at first, so to obtain such robust results after just 8 days, after just one injection, I was very surprised,” he said.
Dr. de Blay and his team screened potential participants to make sure they were cat allergic by exposing them to cat allergen for up to 2 hours while they were in the environmental exposure chamber. To be eligible for the study, participants had to show an early asthmatic response (EAR), defined as a reduction in forced expiratory volume in 1 second (FEV1) of at least 20% from baseline.
The participants were then randomized to receive either single-dose REGN1908-1909, 600 mg, subcutaneously (n = 29 patients) or placebo (n = 27 patients) prior to cat-allergen exposure in the controlled environmental chamber.
Dr. de Blay developed the chamber used in the study: the ALYATEC environmental exposure chamber.
“The chamber is 60 meters square, or 150 cubic meters, and can accommodate 20 patients. We are able to nebulize cat allergen, mice allergen, or whatever we wish to study so we can standardize the exposure. We can control the particle size and the amount so we know the exact amount of allergen that the patient has been exposed to,” he explained.
To test the efficacy of REGN1908-1909 in reducing acute bronchoconstriction, or EAR, the researchers measured FEV1 at baseline, and on days 8, 29, 57, and 85 in both groups. During each exposure, measurements were taken every 10 minutes for periods that lasted up to 4 hours.
They found that the probability of remaining in the chamber with no asthmatic response was substantially elevated in the group treated with REGN1908-1909.
Compared with placebo, REGN1908-1909 significantly increased the median time to EAR, from 51 minutes at baseline to more than 4 hours on day 8, (hazard ratio [HR], 0.36; P < .0083), day 29 (HR, 0.24; P < .0001), day 57 (HR, 0.45; P = .0222), and day 85 (HR, 0.27; P = .0003).
The FEV1 area under the curve (AUC) was also better with REGN1908-1909 than with placebo at day 8 (15.2% vs. 1.6%; P < .001). And a single dose reduced skin-test reactivity to cat allergen at 1 week, which persisted for up to 4 months.
In addition, participants who received REGN1908-1909 were able to tolerate a threefold higher amount of the cat allergen than those who received placebo (P = .003).
“We initially gave 40 nanograms of cat allergen, and then 8 days later they were able to stay longer in the chamber and inhale more of the allergen, to almost triple the amount they had originally been given. That 40 nanograms is very close to real world exposure,” Dr. de Blay noted.
Regeneron plans to start a phase 3 trial soon, he reported.
Promising results
“The study is well designed and shows a reduction in drop of FEV1 in response to cat allergen provocation and a decreased AUC in cat SPT response over 4 months,” Jonathan A. Bernstein, MD, professor of medicine at the University of Cincinnati, said in an interview.
“These are very promising results, which show that REGN1908-1909 can be a novel treatment for cat-induced asthma, which is often the only sensitization patients have. And they love their cats – one-third of the U.S. population has a cat and one-third has a dog, and 50% have both,” noted Dr. Bernstein, who was not involved with the study.
“This novel study used our scientific knowledge of the cat allergen itself to design a targeted antibody-based treatment that demonstrates significant benefit even after the first shot,” added Edwin H. Kim, MD, director of the UNC Food Allergy Initiative at the University of North Carolina at Chapel Hill.
“This strategy has the potential to revolutionize not only our treatment of common environmental allergies but also other allergic diseases with well-described triggers, such as food and drug allergy,” Dr. Kim, who was not part of the study, said in an interview.
Dr. de Blay reported a financial relationship with Regeneron Pharmaceuticals, which sponsored the study. Dr. Bernstein and Dr. Kim have disclosed no relevant financial relationships.
A version of this article first appeared on Medscape.com.
FROM AAAAI
A ‘hospitalist plus’: Grace C. Huang, MD
Editor’s note: This profile is part of SHM’s celebration of National Hospitalist Day on March 4. National Hospitalist Day occurs the first Thursday in March annually, and celebrates the fastest growing specialty in modern medicine and hospitalists’ enduring contributions to the evolving health care landscape.
Grace C. Huang, MD, is a hospitalist at Beth Israel Deaconess Medical Center and an associate professor of medicine at Harvard Medical School, both in Boston.
Dr. Huang currently serves as vice chair for career development and mentoring in the department of medicine at Beth Israel Deaconess as well as director of the Office of Academic Careers and Faculty Development, and codirector of the Beth Israel Deaconess Academy of Medical Educators. She is also director of the Rabkin Fellowship in Medical Education, a program for Harvard Medical School faculty designed to help develop the skills needed to launch or advance academic careers in medical education or academic leadership.
Additionally, Dr. Huang is the editor in chief of MedEdPORTAL, a MEDLINE-indexed, open-access journal of the Association of American Medical Colleges.
At what point in your training did you decide to practice hospital medicine, and what about it appealed to you?
I trained at a point in time where it was rare for people to aspire to go in to hospital medicine. It just wasn’t that common, and there were so few examples of what a career trajectory in hospital medicine would look like. So I don’t know that I actively chose to go into hospital medicine; I chose it because it was what I knew how to do, based on my residency experience.
But it is really easy and authentic for me now to share about what makes hospital medicine such a vibrant career choice. I’m doing a lot of things in my job other than hospital medicine, but when I am on service, it reminds me acutely what it means to stay connected to why I became a doctor. The practice of hospital medicine means to be there at the most intense time of many people’s lives, to shoulder the responsibility of knowing that what I say to my patients will be remembered forever, and to be challenged by some of medicine’s hardest problems.
Hospital medicine has a way of putting you at the nexus of individual, family, society, government, and planet. But it also means that, even while I am witness to disease, suffering, broken relationships, social injustice, and environmental issues, I get a privileged look at what it means to comfort, to identify what really matters to people, to understand what gives us dignity as human beings. Lastly, I always come back to the fact that working as a team has made my clinical job so much more enriching; it’s not trench warfare, but you do create bonds quickly with learners, colleagues, and other health professionals in such an intense, fast-paced environment.
What is your current role at Beth Israel Deaconess Medical Center?
At Beth Israel Deaconess, I’m holding four different jobs. It’s sometimes hard for me to keep track of them, but they all center on career and faculty development. I’m a vice chair for career development within the department of medicine, and I also have an institutional role for faculty development for clinicians, educators, and researchers. I provide academic promotion support for the faculty, provide ad hoc mentorship, and run professional development programming. I also direct a year-long medical education fellowship. On the side, I am the editor in chief for a medical education journal.
What are your favorite areas of clinical practice and research?
Being a generalist means I love a lot of areas of clinical practice. I’m not sure there’s a particular area that I enjoy more than others. I love teaching specific topics – antibiotics, pharmacology, direct oral anticoagulants, the microbiology of common infections. I love thinking about how the heart and kidney battle for dominance each day and being the mediator. I have a particular interest in high-value care and lab ordering (or the fact that we should do much less of it). I love complex diagnostic problems and mapping them out on paper for my team.
The research that I’ve been doing over the past 20 years has focused on how we train internists and internists-to-be to do bedside procedures. It stemmed from my own ineptitude in doing procedures, and it caused me to question the age-old approach we took in sticking needles into patients without standardized training, supervision, or safety measures.
I’ve been proud of the small role I’ve been able to play in influencing how residents are taught to do procedures, and now I’m working with others to focus on how we should teach procedures to hospitalists, who don’t do procedures on a regular basis, and aren’t under the same expectations for ongoing skill development.
What are the most challenging aspects of practicing hospital medicine, and what are the most rewarding?
The intensity is probably what’s hardest for me about hospital medicine. At this point in my career, if I’m on service for a week, it takes me just as long to recover. It’s the cognitive load of needing to keep track of details that can make a big difference, the rapidity at which patients can deteriorate, the need to change course in an instant because of new information, and wanting to be mentally present and available for my patients and my learners.
It’s also hard to see suffering up close and personal and to leave feeling helpless to change the course of severe illness or to optimize care within the constraints of the health care system. This is why I do – and have to – extract satisfaction from the smallest of wins and brief moments of connection. Like seeing a patient turn the corner after being on the brink. Or gaining trust from an initially upset family member. Getting a copy of the eulogy from the daughter of my patient. A phone call from a patient I cared for 18 months ago, thanking me for my care. Visiting patients in the hospital socially that I had gotten to know over the years.
How has COVID-19 impacted hospitalist practice, and what changes will outlast the pandemic?
What you read in the lay press has put a spotlight on hospital-based work. What has been shared resonates with my own experience – the loss of connection from visitor restrictions, the isolation patients experience when everyone is wearing personal protective equipment, the worsening of everything that was already hard to begin with, like health care disparities, mental health, access to community supports, financial challenges, the disproportionate burden on unpaid caregivers, etc.
After the pandemic is “over,” I hope that we will retain a sense of intentionality how we address limited resources, the importance of social connection, the structural racism that has disadvantaged patients and physicians of color.
How will hospital medicine as a field change in the next decade or 2?
The hospitalist model has already influenced other specialties, like ob.gyn., neurology, and cardiology, and I expect that to continue. Hospitalists have already become leaders at the highest levels, and we will see them in higher numbers throughout health care leadership.
Are there any particular mentors who have been influential in your journey as a hospitalist?
Because I’m one of the older hospitalists in my group, there were fewer mentors, other than my boss, Joe Li, MD, SFHM, [section chief in hospital medicine at Beth Israel Deaconess], who has been an amazing role model. I think also of my colleagues as peer mentors, who continue to push me to be a better doctor. Whether it means remaining curious during the physical exam, or inspiring me with their excitement about clinical cases.
Do you have any advice for students and residents interested in hospital medicine?
When I talk to trainees about career development as a hospitalist, I encourage them to think about what will make them a “Hospitalist Plus.” Whether that Plus is teaching, research, or leadership, being a hospitalist gives you an opportunity to extend your impact as a physician into related realm.
I look around at our hospital medicine group, and every person has their Plus. We have educators, quality improvement leaders, a health services researcher, a health policy expert, a textbook editor – everyone brings special expertise to the group. My Plus now is much bigger than my footprint as a hospitalist, but I would never have gotten here had I not chosen a career path that would allow me to explore the farthest reaches of my potential as a physician.
Editor’s note: This profile is part of SHM’s celebration of National Hospitalist Day on March 4. National Hospitalist Day occurs the first Thursday in March annually, and celebrates the fastest growing specialty in modern medicine and hospitalists’ enduring contributions to the evolving health care landscape.
Grace C. Huang, MD, is a hospitalist at Beth Israel Deaconess Medical Center and an associate professor of medicine at Harvard Medical School, both in Boston.
Dr. Huang currently serves as vice chair for career development and mentoring in the department of medicine at Beth Israel Deaconess as well as director of the Office of Academic Careers and Faculty Development, and codirector of the Beth Israel Deaconess Academy of Medical Educators. She is also director of the Rabkin Fellowship in Medical Education, a program for Harvard Medical School faculty designed to help develop the skills needed to launch or advance academic careers in medical education or academic leadership.
Additionally, Dr. Huang is the editor in chief of MedEdPORTAL, a MEDLINE-indexed, open-access journal of the Association of American Medical Colleges.
At what point in your training did you decide to practice hospital medicine, and what about it appealed to you?
I trained at a point in time where it was rare for people to aspire to go in to hospital medicine. It just wasn’t that common, and there were so few examples of what a career trajectory in hospital medicine would look like. So I don’t know that I actively chose to go into hospital medicine; I chose it because it was what I knew how to do, based on my residency experience.
But it is really easy and authentic for me now to share about what makes hospital medicine such a vibrant career choice. I’m doing a lot of things in my job other than hospital medicine, but when I am on service, it reminds me acutely what it means to stay connected to why I became a doctor. The practice of hospital medicine means to be there at the most intense time of many people’s lives, to shoulder the responsibility of knowing that what I say to my patients will be remembered forever, and to be challenged by some of medicine’s hardest problems.
Hospital medicine has a way of putting you at the nexus of individual, family, society, government, and planet. But it also means that, even while I am witness to disease, suffering, broken relationships, social injustice, and environmental issues, I get a privileged look at what it means to comfort, to identify what really matters to people, to understand what gives us dignity as human beings. Lastly, I always come back to the fact that working as a team has made my clinical job so much more enriching; it’s not trench warfare, but you do create bonds quickly with learners, colleagues, and other health professionals in such an intense, fast-paced environment.
What is your current role at Beth Israel Deaconess Medical Center?
At Beth Israel Deaconess, I’m holding four different jobs. It’s sometimes hard for me to keep track of them, but they all center on career and faculty development. I’m a vice chair for career development within the department of medicine, and I also have an institutional role for faculty development for clinicians, educators, and researchers. I provide academic promotion support for the faculty, provide ad hoc mentorship, and run professional development programming. I also direct a year-long medical education fellowship. On the side, I am the editor in chief for a medical education journal.
What are your favorite areas of clinical practice and research?
Being a generalist means I love a lot of areas of clinical practice. I’m not sure there’s a particular area that I enjoy more than others. I love teaching specific topics – antibiotics, pharmacology, direct oral anticoagulants, the microbiology of common infections. I love thinking about how the heart and kidney battle for dominance each day and being the mediator. I have a particular interest in high-value care and lab ordering (or the fact that we should do much less of it). I love complex diagnostic problems and mapping them out on paper for my team.
The research that I’ve been doing over the past 20 years has focused on how we train internists and internists-to-be to do bedside procedures. It stemmed from my own ineptitude in doing procedures, and it caused me to question the age-old approach we took in sticking needles into patients without standardized training, supervision, or safety measures.
I’ve been proud of the small role I’ve been able to play in influencing how residents are taught to do procedures, and now I’m working with others to focus on how we should teach procedures to hospitalists, who don’t do procedures on a regular basis, and aren’t under the same expectations for ongoing skill development.
What are the most challenging aspects of practicing hospital medicine, and what are the most rewarding?
The intensity is probably what’s hardest for me about hospital medicine. At this point in my career, if I’m on service for a week, it takes me just as long to recover. It’s the cognitive load of needing to keep track of details that can make a big difference, the rapidity at which patients can deteriorate, the need to change course in an instant because of new information, and wanting to be mentally present and available for my patients and my learners.
It’s also hard to see suffering up close and personal and to leave feeling helpless to change the course of severe illness or to optimize care within the constraints of the health care system. This is why I do – and have to – extract satisfaction from the smallest of wins and brief moments of connection. Like seeing a patient turn the corner after being on the brink. Or gaining trust from an initially upset family member. Getting a copy of the eulogy from the daughter of my patient. A phone call from a patient I cared for 18 months ago, thanking me for my care. Visiting patients in the hospital socially that I had gotten to know over the years.
How has COVID-19 impacted hospitalist practice, and what changes will outlast the pandemic?
What you read in the lay press has put a spotlight on hospital-based work. What has been shared resonates with my own experience – the loss of connection from visitor restrictions, the isolation patients experience when everyone is wearing personal protective equipment, the worsening of everything that was already hard to begin with, like health care disparities, mental health, access to community supports, financial challenges, the disproportionate burden on unpaid caregivers, etc.
After the pandemic is “over,” I hope that we will retain a sense of intentionality how we address limited resources, the importance of social connection, the structural racism that has disadvantaged patients and physicians of color.
How will hospital medicine as a field change in the next decade or 2?
The hospitalist model has already influenced other specialties, like ob.gyn., neurology, and cardiology, and I expect that to continue. Hospitalists have already become leaders at the highest levels, and we will see them in higher numbers throughout health care leadership.
Are there any particular mentors who have been influential in your journey as a hospitalist?
Because I’m one of the older hospitalists in my group, there were fewer mentors, other than my boss, Joe Li, MD, SFHM, [section chief in hospital medicine at Beth Israel Deaconess], who has been an amazing role model. I think also of my colleagues as peer mentors, who continue to push me to be a better doctor. Whether it means remaining curious during the physical exam, or inspiring me with their excitement about clinical cases.
Do you have any advice for students and residents interested in hospital medicine?
When I talk to trainees about career development as a hospitalist, I encourage them to think about what will make them a “Hospitalist Plus.” Whether that Plus is teaching, research, or leadership, being a hospitalist gives you an opportunity to extend your impact as a physician into related realm.
I look around at our hospital medicine group, and every person has their Plus. We have educators, quality improvement leaders, a health services researcher, a health policy expert, a textbook editor – everyone brings special expertise to the group. My Plus now is much bigger than my footprint as a hospitalist, but I would never have gotten here had I not chosen a career path that would allow me to explore the farthest reaches of my potential as a physician.
Editor’s note: This profile is part of SHM’s celebration of National Hospitalist Day on March 4. National Hospitalist Day occurs the first Thursday in March annually, and celebrates the fastest growing specialty in modern medicine and hospitalists’ enduring contributions to the evolving health care landscape.
Grace C. Huang, MD, is a hospitalist at Beth Israel Deaconess Medical Center and an associate professor of medicine at Harvard Medical School, both in Boston.
Dr. Huang currently serves as vice chair for career development and mentoring in the department of medicine at Beth Israel Deaconess as well as director of the Office of Academic Careers and Faculty Development, and codirector of the Beth Israel Deaconess Academy of Medical Educators. She is also director of the Rabkin Fellowship in Medical Education, a program for Harvard Medical School faculty designed to help develop the skills needed to launch or advance academic careers in medical education or academic leadership.
Additionally, Dr. Huang is the editor in chief of MedEdPORTAL, a MEDLINE-indexed, open-access journal of the Association of American Medical Colleges.
At what point in your training did you decide to practice hospital medicine, and what about it appealed to you?
I trained at a point in time where it was rare for people to aspire to go in to hospital medicine. It just wasn’t that common, and there were so few examples of what a career trajectory in hospital medicine would look like. So I don’t know that I actively chose to go into hospital medicine; I chose it because it was what I knew how to do, based on my residency experience.
But it is really easy and authentic for me now to share about what makes hospital medicine such a vibrant career choice. I’m doing a lot of things in my job other than hospital medicine, but when I am on service, it reminds me acutely what it means to stay connected to why I became a doctor. The practice of hospital medicine means to be there at the most intense time of many people’s lives, to shoulder the responsibility of knowing that what I say to my patients will be remembered forever, and to be challenged by some of medicine’s hardest problems.
Hospital medicine has a way of putting you at the nexus of individual, family, society, government, and planet. But it also means that, even while I am witness to disease, suffering, broken relationships, social injustice, and environmental issues, I get a privileged look at what it means to comfort, to identify what really matters to people, to understand what gives us dignity as human beings. Lastly, I always come back to the fact that working as a team has made my clinical job so much more enriching; it’s not trench warfare, but you do create bonds quickly with learners, colleagues, and other health professionals in such an intense, fast-paced environment.
What is your current role at Beth Israel Deaconess Medical Center?
At Beth Israel Deaconess, I’m holding four different jobs. It’s sometimes hard for me to keep track of them, but they all center on career and faculty development. I’m a vice chair for career development within the department of medicine, and I also have an institutional role for faculty development for clinicians, educators, and researchers. I provide academic promotion support for the faculty, provide ad hoc mentorship, and run professional development programming. I also direct a year-long medical education fellowship. On the side, I am the editor in chief for a medical education journal.
What are your favorite areas of clinical practice and research?
Being a generalist means I love a lot of areas of clinical practice. I’m not sure there’s a particular area that I enjoy more than others. I love teaching specific topics – antibiotics, pharmacology, direct oral anticoagulants, the microbiology of common infections. I love thinking about how the heart and kidney battle for dominance each day and being the mediator. I have a particular interest in high-value care and lab ordering (or the fact that we should do much less of it). I love complex diagnostic problems and mapping them out on paper for my team.
The research that I’ve been doing over the past 20 years has focused on how we train internists and internists-to-be to do bedside procedures. It stemmed from my own ineptitude in doing procedures, and it caused me to question the age-old approach we took in sticking needles into patients without standardized training, supervision, or safety measures.
I’ve been proud of the small role I’ve been able to play in influencing how residents are taught to do procedures, and now I’m working with others to focus on how we should teach procedures to hospitalists, who don’t do procedures on a regular basis, and aren’t under the same expectations for ongoing skill development.
What are the most challenging aspects of practicing hospital medicine, and what are the most rewarding?
The intensity is probably what’s hardest for me about hospital medicine. At this point in my career, if I’m on service for a week, it takes me just as long to recover. It’s the cognitive load of needing to keep track of details that can make a big difference, the rapidity at which patients can deteriorate, the need to change course in an instant because of new information, and wanting to be mentally present and available for my patients and my learners.
It’s also hard to see suffering up close and personal and to leave feeling helpless to change the course of severe illness or to optimize care within the constraints of the health care system. This is why I do – and have to – extract satisfaction from the smallest of wins and brief moments of connection. Like seeing a patient turn the corner after being on the brink. Or gaining trust from an initially upset family member. Getting a copy of the eulogy from the daughter of my patient. A phone call from a patient I cared for 18 months ago, thanking me for my care. Visiting patients in the hospital socially that I had gotten to know over the years.
How has COVID-19 impacted hospitalist practice, and what changes will outlast the pandemic?
What you read in the lay press has put a spotlight on hospital-based work. What has been shared resonates with my own experience – the loss of connection from visitor restrictions, the isolation patients experience when everyone is wearing personal protective equipment, the worsening of everything that was already hard to begin with, like health care disparities, mental health, access to community supports, financial challenges, the disproportionate burden on unpaid caregivers, etc.
After the pandemic is “over,” I hope that we will retain a sense of intentionality how we address limited resources, the importance of social connection, the structural racism that has disadvantaged patients and physicians of color.
How will hospital medicine as a field change in the next decade or 2?
The hospitalist model has already influenced other specialties, like ob.gyn., neurology, and cardiology, and I expect that to continue. Hospitalists have already become leaders at the highest levels, and we will see them in higher numbers throughout health care leadership.
Are there any particular mentors who have been influential in your journey as a hospitalist?
Because I’m one of the older hospitalists in my group, there were fewer mentors, other than my boss, Joe Li, MD, SFHM, [section chief in hospital medicine at Beth Israel Deaconess], who has been an amazing role model. I think also of my colleagues as peer mentors, who continue to push me to be a better doctor. Whether it means remaining curious during the physical exam, or inspiring me with their excitement about clinical cases.
Do you have any advice for students and residents interested in hospital medicine?
When I talk to trainees about career development as a hospitalist, I encourage them to think about what will make them a “Hospitalist Plus.” Whether that Plus is teaching, research, or leadership, being a hospitalist gives you an opportunity to extend your impact as a physician into related realm.
I look around at our hospital medicine group, and every person has their Plus. We have educators, quality improvement leaders, a health services researcher, a health policy expert, a textbook editor – everyone brings special expertise to the group. My Plus now is much bigger than my footprint as a hospitalist, but I would never have gotten here had I not chosen a career path that would allow me to explore the farthest reaches of my potential as a physician.
Painless Mobile Nodule on the Shoulder
The Diagnosis: Cutaneous Metaplastic Synovial Cyst
Gross examination of the excised nodule revealed a 2.5×1.2×1.0-cm, intact, gray-white, thin-walled, smooth-lined nodule filled with clear mucinouslike material. Hematoxylin and eosin-stained sections demonstrated a dermal-based cystlike structure composed of a lining of connective tissue with hyalinized material and fibrin as well as spindle and epithelioid cells with a mild mixed inflammatory infiltrate (Figure). These histopathologic findings led to the diagnosis of cutaneous metaplastic synovial cyst (CMSC).
Cutaneous metaplastic synovial cyst, also known as synovial metaplasia of the skin, is an uncommon benign cystic lesion that was first reported by Gonzalez et al1 in 1987. Histologically, CMSC lacks an epithelial lining and therefore is not a true cyst but rather a pseudocyst.2 Clinically, the lesion typically presents as a solitary subcutaneous nodule that may be tender or painless. In a literature review of CMSC cases performed by Fukuyama et al,3 distribution of reported cases according to body site varied; however, limbs were found to be the most commonly involved area. A PubMed search of articles indexed for MEDLINE as well as a Google Scholar search using the term cutaneous metaplastic synovial cyst revealed at least 37 cases reported in the English-language literature,3-9 including our present case. The pathogenesis remains uncertain; however, a majority of previously reported cases of CMSC characteristically have been associated with a pre-existing lesion, with most presentations developing at surgical scar sites secondary to operation or trauma.5 Relative tissue fragility secondary to rheumatoid arthritis10 and Ehlers-Danlos syndrome9,11,12 has been linked to CMSC in some documented reports, while a minority of cases report no antecedent events triggering formation of the lesion.13-15
As evidenced by our patient, CMSC clinically mimics several other benign entities; histopathologic examination is necessary to confirm the diagnosis. Although nodular hidradenoma also may clinically present as a solitary firm intradermal nodule, microscopy reveals a dermal-based lobulated tumor containing cystic spaces and solid areas composed of basophilic polyhedral cells and round glycogen-filled clear cells.16 Epidermoid cysts are differentiated from CMSC by the presence of a cyst wall lining composed of stratified squamous epithelium and associated laminated keratin within the lumen,17 which corresponds to its pearly white appearance on gross examination. Cutaneous ciliated cysts predominantly occur on the lower extremities of young women and are lined by simple cuboidal or columnar ciliated cells that resemble müllerian epithelium.18 Similar to CMSC, ganglion cysts are pseudocysts that lack a true epithelial lining but differ in appearance due to their mucin-filled synovial-lined sac.19 Additionally, ganglion cysts most often occur on the dorsal and volar aspects of the wrist.
Excisional biopsy is indicated as the preferred treatment of CMSC, given the lesion's benign behavior and low recurrence rate.6 Our case highlights this rare entity and reinforces its inclusion in the differential diagnosis of subcutaneous mobile nodules, especially in the setting of prior tissue injury secondary to trauma, surgical procedures, or conditions such as rheumatoid arthritis or Ehlers-Danlos syndrome. Unlike most previously reported cases, our patient reported no preceding tissue injury associated with formation of the lesion, and she was largely asymptomatic on presentation. Considering the limited number of CMSC cases demonstrated in the literature, it is important to continue reporting new cases to better understand characteristics and presentations of this uncommon lesion.
- Gonzalez JG, Ghiselli RW, Santa Cruz DJ. Synovial metaplasia of the skin. Am J Surg Pathol. 1987;11:343-350.
- Calonje E, Brenn T, Lazar A, et al. Cutaneous cysts. In: Calonje E, Brenn T, Lazar A, et al. McKee's Pathology of the Skin. 5th ed. Elsevier Limited; 2020:1680-1697.
- Fukuyama M, Sato Y, Hayakawa J, et al. Cutaneous metaplastic synovial cyst: case report and literature review from the dermatological point of view. Keio J Med. 2016;66:9-13.
- Karaytug K, Kapicioglu M, Can N, et al. Unprecedented recurrence of carpal tunnel syndrome by metaplastic synovial cyst in the carpal tunnel. Acta Orthop Traumatol Turc. 2019;53:230-232.
- Martelli SJ, Silveira FM, Carvalho PH, et al. Asymptomatic subcutaneous swelling of lower face. Oral Surg Oral Med Oral Pathol Oral Radiol. 2019;128:101-105.
- Majdi M, Saffar H, Ghanadan A. Cutaneous metaplastic synovial cyst: a case report. Iran J Pathol. 2016;11:423-426.
- Ramachandra S, Rao L, Al-Kindi M. Cutaneous metaplastic synovial cyst. Sultan Qaboos Univ Med J. 2016;16:E117-E118.
- Heidarian A, Xie Q, Banihashemi A. Cutaneous metaplastic synovial cyst presenting as an axillary mass after modified mastectomy and adjuvant radiotherapy. Am J Clin Pathol. 2016;146:S2.
- Fernandez-Flores A, Barja-Lopez JM. Cutaneous metaplastic synovial cyst in Ehlers-Danlos syndrome. J Cutan Pathol. 2020;47:729-733.
- Choonhakarn C, Tang S. Cutaneous metaplastic synovial cyst. J Dermatol. 2003;30:480-484.
- Guala A, Viglio S, Ottinetti A, et al. Cutaneous metaplastic synovial cyst in Ehlers-Danlos syndrome: report of a second case. Am J Dermatopathol. 2008;30:59-61.
- Nieto S, Buezo GF, Jones-Caballero M, et al. Cutaneous metaplastic synovial cyst in an Ehlers-Danlos patient. Am J Dermatopathol. 1997;19:407-410.
- Goiriz R, Rios-Buceta L, Alonso-Perez A, et al. Cutaneous metaplastic synovial cyst. J Am Acad Dermatol. 2005;53:180-181.
- Kim BC, Choi WJ, Park EJ, et al. Cutaneous metaplastic synovial cyst of the first metatarsal head area. Ann Dermatol. 2011;23(suppl 2):S165-S168.
- Yang HC, Tsai YJ, Hu SL, et al. Cutaneous metaplastic synovial cyst--a case report and review of literature. Dermatol Sinica. 2003;21:275-279.
- Kataria SP, Singh G, Batra A, et al. Nodular hidradenoma: a series of five cases in male subjects and review of literature. Adv Cytol Pathol. 2018;3:46-47.
- Mohamed Haflah N, Mohd Kassim A, Hassan Shukur M. Giant epidermoid cyst of the thigh. Malays Orthop J. 2011;5:17-19.
- Torisu-Itakura H, Itakura E, Horiuchi R, et al. Cutaneous ciliated cyst on the leg of a woman of menopausal age. Acta Derm Venereol. 2009;89:323-324.
- Fullen DR. Cysts and sinuses. In: Busam K, ed. Dermatopathology. Saunders; 2010:300-330.
The Diagnosis: Cutaneous Metaplastic Synovial Cyst
Gross examination of the excised nodule revealed a 2.5×1.2×1.0-cm, intact, gray-white, thin-walled, smooth-lined nodule filled with clear mucinouslike material. Hematoxylin and eosin-stained sections demonstrated a dermal-based cystlike structure composed of a lining of connective tissue with hyalinized material and fibrin as well as spindle and epithelioid cells with a mild mixed inflammatory infiltrate (Figure). These histopathologic findings led to the diagnosis of cutaneous metaplastic synovial cyst (CMSC).
Cutaneous metaplastic synovial cyst, also known as synovial metaplasia of the skin, is an uncommon benign cystic lesion that was first reported by Gonzalez et al1 in 1987. Histologically, CMSC lacks an epithelial lining and therefore is not a true cyst but rather a pseudocyst.2 Clinically, the lesion typically presents as a solitary subcutaneous nodule that may be tender or painless. In a literature review of CMSC cases performed by Fukuyama et al,3 distribution of reported cases according to body site varied; however, limbs were found to be the most commonly involved area. A PubMed search of articles indexed for MEDLINE as well as a Google Scholar search using the term cutaneous metaplastic synovial cyst revealed at least 37 cases reported in the English-language literature,3-9 including our present case. The pathogenesis remains uncertain; however, a majority of previously reported cases of CMSC characteristically have been associated with a pre-existing lesion, with most presentations developing at surgical scar sites secondary to operation or trauma.5 Relative tissue fragility secondary to rheumatoid arthritis10 and Ehlers-Danlos syndrome9,11,12 has been linked to CMSC in some documented reports, while a minority of cases report no antecedent events triggering formation of the lesion.13-15
As evidenced by our patient, CMSC clinically mimics several other benign entities; histopathologic examination is necessary to confirm the diagnosis. Although nodular hidradenoma also may clinically present as a solitary firm intradermal nodule, microscopy reveals a dermal-based lobulated tumor containing cystic spaces and solid areas composed of basophilic polyhedral cells and round glycogen-filled clear cells.16 Epidermoid cysts are differentiated from CMSC by the presence of a cyst wall lining composed of stratified squamous epithelium and associated laminated keratin within the lumen,17 which corresponds to its pearly white appearance on gross examination. Cutaneous ciliated cysts predominantly occur on the lower extremities of young women and are lined by simple cuboidal or columnar ciliated cells that resemble müllerian epithelium.18 Similar to CMSC, ganglion cysts are pseudocysts that lack a true epithelial lining but differ in appearance due to their mucin-filled synovial-lined sac.19 Additionally, ganglion cysts most often occur on the dorsal and volar aspects of the wrist.
Excisional biopsy is indicated as the preferred treatment of CMSC, given the lesion's benign behavior and low recurrence rate.6 Our case highlights this rare entity and reinforces its inclusion in the differential diagnosis of subcutaneous mobile nodules, especially in the setting of prior tissue injury secondary to trauma, surgical procedures, or conditions such as rheumatoid arthritis or Ehlers-Danlos syndrome. Unlike most previously reported cases, our patient reported no preceding tissue injury associated with formation of the lesion, and she was largely asymptomatic on presentation. Considering the limited number of CMSC cases demonstrated in the literature, it is important to continue reporting new cases to better understand characteristics and presentations of this uncommon lesion.
The Diagnosis: Cutaneous Metaplastic Synovial Cyst
Gross examination of the excised nodule revealed a 2.5×1.2×1.0-cm, intact, gray-white, thin-walled, smooth-lined nodule filled with clear mucinouslike material. Hematoxylin and eosin-stained sections demonstrated a dermal-based cystlike structure composed of a lining of connective tissue with hyalinized material and fibrin as well as spindle and epithelioid cells with a mild mixed inflammatory infiltrate (Figure). These histopathologic findings led to the diagnosis of cutaneous metaplastic synovial cyst (CMSC).
Cutaneous metaplastic synovial cyst, also known as synovial metaplasia of the skin, is an uncommon benign cystic lesion that was first reported by Gonzalez et al1 in 1987. Histologically, CMSC lacks an epithelial lining and therefore is not a true cyst but rather a pseudocyst.2 Clinically, the lesion typically presents as a solitary subcutaneous nodule that may be tender or painless. In a literature review of CMSC cases performed by Fukuyama et al,3 distribution of reported cases according to body site varied; however, limbs were found to be the most commonly involved area. A PubMed search of articles indexed for MEDLINE as well as a Google Scholar search using the term cutaneous metaplastic synovial cyst revealed at least 37 cases reported in the English-language literature,3-9 including our present case. The pathogenesis remains uncertain; however, a majority of previously reported cases of CMSC characteristically have been associated with a pre-existing lesion, with most presentations developing at surgical scar sites secondary to operation or trauma.5 Relative tissue fragility secondary to rheumatoid arthritis10 and Ehlers-Danlos syndrome9,11,12 has been linked to CMSC in some documented reports, while a minority of cases report no antecedent events triggering formation of the lesion.13-15
As evidenced by our patient, CMSC clinically mimics several other benign entities; histopathologic examination is necessary to confirm the diagnosis. Although nodular hidradenoma also may clinically present as a solitary firm intradermal nodule, microscopy reveals a dermal-based lobulated tumor containing cystic spaces and solid areas composed of basophilic polyhedral cells and round glycogen-filled clear cells.16 Epidermoid cysts are differentiated from CMSC by the presence of a cyst wall lining composed of stratified squamous epithelium and associated laminated keratin within the lumen,17 which corresponds to its pearly white appearance on gross examination. Cutaneous ciliated cysts predominantly occur on the lower extremities of young women and are lined by simple cuboidal or columnar ciliated cells that resemble müllerian epithelium.18 Similar to CMSC, ganglion cysts are pseudocysts that lack a true epithelial lining but differ in appearance due to their mucin-filled synovial-lined sac.19 Additionally, ganglion cysts most often occur on the dorsal and volar aspects of the wrist.
Excisional biopsy is indicated as the preferred treatment of CMSC, given the lesion's benign behavior and low recurrence rate.6 Our case highlights this rare entity and reinforces its inclusion in the differential diagnosis of subcutaneous mobile nodules, especially in the setting of prior tissue injury secondary to trauma, surgical procedures, or conditions such as rheumatoid arthritis or Ehlers-Danlos syndrome. Unlike most previously reported cases, our patient reported no preceding tissue injury associated with formation of the lesion, and she was largely asymptomatic on presentation. Considering the limited number of CMSC cases demonstrated in the literature, it is important to continue reporting new cases to better understand characteristics and presentations of this uncommon lesion.
- Gonzalez JG, Ghiselli RW, Santa Cruz DJ. Synovial metaplasia of the skin. Am J Surg Pathol. 1987;11:343-350.
- Calonje E, Brenn T, Lazar A, et al. Cutaneous cysts. In: Calonje E, Brenn T, Lazar A, et al. McKee's Pathology of the Skin. 5th ed. Elsevier Limited; 2020:1680-1697.
- Fukuyama M, Sato Y, Hayakawa J, et al. Cutaneous metaplastic synovial cyst: case report and literature review from the dermatological point of view. Keio J Med. 2016;66:9-13.
- Karaytug K, Kapicioglu M, Can N, et al. Unprecedented recurrence of carpal tunnel syndrome by metaplastic synovial cyst in the carpal tunnel. Acta Orthop Traumatol Turc. 2019;53:230-232.
- Martelli SJ, Silveira FM, Carvalho PH, et al. Asymptomatic subcutaneous swelling of lower face. Oral Surg Oral Med Oral Pathol Oral Radiol. 2019;128:101-105.
- Majdi M, Saffar H, Ghanadan A. Cutaneous metaplastic synovial cyst: a case report. Iran J Pathol. 2016;11:423-426.
- Ramachandra S, Rao L, Al-Kindi M. Cutaneous metaplastic synovial cyst. Sultan Qaboos Univ Med J. 2016;16:E117-E118.
- Heidarian A, Xie Q, Banihashemi A. Cutaneous metaplastic synovial cyst presenting as an axillary mass after modified mastectomy and adjuvant radiotherapy. Am J Clin Pathol. 2016;146:S2.
- Fernandez-Flores A, Barja-Lopez JM. Cutaneous metaplastic synovial cyst in Ehlers-Danlos syndrome. J Cutan Pathol. 2020;47:729-733.
- Choonhakarn C, Tang S. Cutaneous metaplastic synovial cyst. J Dermatol. 2003;30:480-484.
- Guala A, Viglio S, Ottinetti A, et al. Cutaneous metaplastic synovial cyst in Ehlers-Danlos syndrome: report of a second case. Am J Dermatopathol. 2008;30:59-61.
- Nieto S, Buezo GF, Jones-Caballero M, et al. Cutaneous metaplastic synovial cyst in an Ehlers-Danlos patient. Am J Dermatopathol. 1997;19:407-410.
- Goiriz R, Rios-Buceta L, Alonso-Perez A, et al. Cutaneous metaplastic synovial cyst. J Am Acad Dermatol. 2005;53:180-181.
- Kim BC, Choi WJ, Park EJ, et al. Cutaneous metaplastic synovial cyst of the first metatarsal head area. Ann Dermatol. 2011;23(suppl 2):S165-S168.
- Yang HC, Tsai YJ, Hu SL, et al. Cutaneous metaplastic synovial cyst--a case report and review of literature. Dermatol Sinica. 2003;21:275-279.
- Kataria SP, Singh G, Batra A, et al. Nodular hidradenoma: a series of five cases in male subjects and review of literature. Adv Cytol Pathol. 2018;3:46-47.
- Mohamed Haflah N, Mohd Kassim A, Hassan Shukur M. Giant epidermoid cyst of the thigh. Malays Orthop J. 2011;5:17-19.
- Torisu-Itakura H, Itakura E, Horiuchi R, et al. Cutaneous ciliated cyst on the leg of a woman of menopausal age. Acta Derm Venereol. 2009;89:323-324.
- Fullen DR. Cysts and sinuses. In: Busam K, ed. Dermatopathology. Saunders; 2010:300-330.
- Gonzalez JG, Ghiselli RW, Santa Cruz DJ. Synovial metaplasia of the skin. Am J Surg Pathol. 1987;11:343-350.
- Calonje E, Brenn T, Lazar A, et al. Cutaneous cysts. In: Calonje E, Brenn T, Lazar A, et al. McKee's Pathology of the Skin. 5th ed. Elsevier Limited; 2020:1680-1697.
- Fukuyama M, Sato Y, Hayakawa J, et al. Cutaneous metaplastic synovial cyst: case report and literature review from the dermatological point of view. Keio J Med. 2016;66:9-13.
- Karaytug K, Kapicioglu M, Can N, et al. Unprecedented recurrence of carpal tunnel syndrome by metaplastic synovial cyst in the carpal tunnel. Acta Orthop Traumatol Turc. 2019;53:230-232.
- Martelli SJ, Silveira FM, Carvalho PH, et al. Asymptomatic subcutaneous swelling of lower face. Oral Surg Oral Med Oral Pathol Oral Radiol. 2019;128:101-105.
- Majdi M, Saffar H, Ghanadan A. Cutaneous metaplastic synovial cyst: a case report. Iran J Pathol. 2016;11:423-426.
- Ramachandra S, Rao L, Al-Kindi M. Cutaneous metaplastic synovial cyst. Sultan Qaboos Univ Med J. 2016;16:E117-E118.
- Heidarian A, Xie Q, Banihashemi A. Cutaneous metaplastic synovial cyst presenting as an axillary mass after modified mastectomy and adjuvant radiotherapy. Am J Clin Pathol. 2016;146:S2.
- Fernandez-Flores A, Barja-Lopez JM. Cutaneous metaplastic synovial cyst in Ehlers-Danlos syndrome. J Cutan Pathol. 2020;47:729-733.
- Choonhakarn C, Tang S. Cutaneous metaplastic synovial cyst. J Dermatol. 2003;30:480-484.
- Guala A, Viglio S, Ottinetti A, et al. Cutaneous metaplastic synovial cyst in Ehlers-Danlos syndrome: report of a second case. Am J Dermatopathol. 2008;30:59-61.
- Nieto S, Buezo GF, Jones-Caballero M, et al. Cutaneous metaplastic synovial cyst in an Ehlers-Danlos patient. Am J Dermatopathol. 1997;19:407-410.
- Goiriz R, Rios-Buceta L, Alonso-Perez A, et al. Cutaneous metaplastic synovial cyst. J Am Acad Dermatol. 2005;53:180-181.
- Kim BC, Choi WJ, Park EJ, et al. Cutaneous metaplastic synovial cyst of the first metatarsal head area. Ann Dermatol. 2011;23(suppl 2):S165-S168.
- Yang HC, Tsai YJ, Hu SL, et al. Cutaneous metaplastic synovial cyst--a case report and review of literature. Dermatol Sinica. 2003;21:275-279.
- Kataria SP, Singh G, Batra A, et al. Nodular hidradenoma: a series of five cases in male subjects and review of literature. Adv Cytol Pathol. 2018;3:46-47.
- Mohamed Haflah N, Mohd Kassim A, Hassan Shukur M. Giant epidermoid cyst of the thigh. Malays Orthop J. 2011;5:17-19.
- Torisu-Itakura H, Itakura E, Horiuchi R, et al. Cutaneous ciliated cyst on the leg of a woman of menopausal age. Acta Derm Venereol. 2009;89:323-324.
- Fullen DR. Cysts and sinuses. In: Busam K, ed. Dermatopathology. Saunders; 2010:300-330.
A 70-year-old woman presented to the outpatient dermatology clinic with an acute-onset lesion on the right shoulder. She first noticed a “cyst” developing in the area approximately 3 weeks prior but noted that it may have been present longer. The lesion was bothersome when her undergarments rubbed against it, but she otherwise denied pain, increase in size, or drainage from the site. Her medical history was remarkable for a proliferating trichilemmal tumor on the right parietal scalp treated with Mohs surgery approximately 13 years prior to presentation. She had no personal or family history of skin cancer. Physical examination revealed a 2.5-cm, mobile, nontender, flesh-colored subcutaneous nodule on the right shoulder (top); no ulceration, bleeding, or drainage was present. The surrounding skin demonstrated no clinical changes. The patient was scheduled for outpatient surgical excision of the nodule, which initially was suspected to be a lipoma. During the excision, a translucent cystlike nodule (bottom) was gently dissected and sent for histopathologic examination.
Mepolizumab reduced exacerbations in patients with asthma and atopy, depression comorbidities
, according to research from the annual meeting of the American Academy of Allergy, Asthma, and Immunology.
“Mepolizumab has clearly been shown to improve severe asthma control in many clinical trials, but atopy, obesity, and depression/anxiety affect patients with asthma at an increased rate,” Thomas B. Casale, MD, former AAAAI president and professor of medicine and pediatrics at the University of South Florida in Tampa, said in a presentation at the meeting. “Yet, few studies have examined whether asthma therapy with these comorbidities works.”
Dr. Casale and colleagues performed a retrospective analysis of patients in the United States from the MarketScan Commercial and Medicare Supplemental Database between November 2014 and December 2018 who had atopy, obesity, or depression/anxiety in addition to asthma and were receiving mepolizumab. Atopy in the study was defined as allergic rhinitis, anaphylaxis, atopic dermatitis, conjunctivitis, eosinophilic esophagitis, and food allergies. Patients were at least age 12 years, had at least one diagnosis for asthma, at least one diagnosis code for atopic disease, obesity, or depression/anxiety at baseline, and at least two administrations of mepolizumab within 180 days.
The researchers examined the number of exacerbations, oral corticosteroid (OCS) claims, and OCS bursts per year at 12-month follow-up, compared with baseline. They identified exacerbations by examining patients who had an emergency department or outpatient claim related to their asthma, and a claim for systemic corticosteroids made in the 4 days prior to or 5 days after a visit, or if their inpatient hospital admission contained a primary asthma diagnosis. Dr. Casale and colleagues measured OCS bursts as a pharmacy claim of at least 20 mg of prednisone per day for between 3 and 28 days plus a claim for an emergency department visit related to asthma in the 7 days prior or 6 days after the claim.
At baseline, patients across all groups were mean age 50.5-52.4 years with a Charleson Comorbidity Index score between 1.1 and 1.4, a majority were women (59.0%-72.0%) and nearly all were commercially insured (88.0%-90.0%). Patients who used biologics at baseline and/or used a biologic that wasn’t mepolizumab during the follow-up period were excluded.
Medication claims in the groups included inhaled corticosteroids (ICS) (36.8%-48.6%), ICS/long-acting beta-agonist (LABA) (60.2%-63.0%), LABA/ long-acting muscarinic antagonist (LAMA) (1.2%-3.5%), ICS/LABA/LAMA (21.2%-25.1%), short-acting beta-agonist (SABA) (83.2%-87.7%), LAMA alone (33.5%-42.1%), or leukotriene receptor antagonist (LTRA).
In the non–mutually exclusive group of patients with atopy (468 patients), 28.0% had comorbid obesity and 26.0% had comorbid depression/anxiety. For patients with obesity categorized in a non–mutually exclusive subgroup (171 patients), 79.0% had comorbid atopy and 32.0% had comorbid depression/anxiety. Among patients with non–mutually exclusive depression/anxiety (173 patients), 70.0% had comorbid atopy, while 32.0% had comorbid obesity.
The results showed the mean number of overall exacerbations decreased by 48% at 12 months in the atopic group (2.3 vs. 1.2; P < .001), 52% in the group with obesity (2.5 vs. 1.2; P < .001), and 38% in the depression/anxiety group (2.4 vs. 1.5; P < .001). The mean number of exacerbations leading to hospitalizations decreased by 64% in the atopic group (0.11 vs. 0.04; P < .001), 65% in the group with obesity (0.20 vs. 0.07; P < .001), and 68% in the group with depression/anxiety (0.22 vs. 0.07; P < .001).
The researchers also found the mean number of OCS claims and OCS bursts also significantly decreased over the 12-month follow-up period. Mean OCS claims decreased by 33% for patients in the atopic group (5.5 vs. 3.7; P < .001), by 38% in the group with obesity (6.1 vs. 3.8; P < .001), and by 31% in the group with depression/anxiety (6.2 vs. 4.3; P < .001).
The mean number of OCS bursts also significantly decreased by 40% in the atopic group (2.0 vs. 2.1; P < .001), 48% in the group with obesity (2.3 vs. 1.2; P < .001), and by 37% in the group with depression/anxiety (1.9 vs. 1.2; P < .001). In total, 69% of patients with comorbid atopy, 70.8% of patients with comorbid obesity, and 68.2% of patients with comorbid depression/anxiety experienced a mean decrease in their OCS dose over 12 months.
“These data demonstrate that patients with asthma and atopy, obesity, or depression and anxiety have significantly fewer exacerbations and reduced OCS use in a real-world setting with treatment of mepolizumab,” Dr. Casale said. “Thus, holistic patient care for severe asthma is critical, and mepolizumab provides tangible clinical benefit despite the complexities of medical comorbidities.”
This study was funded by GlaxoSmithKline, and the company also funded graphic design support of the poster. Dr. Casale reports he has received research funds from GlaxoSmithKline. Four authors report being current or former GlaxoSmithKline employees; three authors report holding stock and/or shares of GlaxoSmithKline. Three authors are IBM Watson Health employees, a company GlaxoSmithKline has provided research funding.
, according to research from the annual meeting of the American Academy of Allergy, Asthma, and Immunology.
“Mepolizumab has clearly been shown to improve severe asthma control in many clinical trials, but atopy, obesity, and depression/anxiety affect patients with asthma at an increased rate,” Thomas B. Casale, MD, former AAAAI president and professor of medicine and pediatrics at the University of South Florida in Tampa, said in a presentation at the meeting. “Yet, few studies have examined whether asthma therapy with these comorbidities works.”
Dr. Casale and colleagues performed a retrospective analysis of patients in the United States from the MarketScan Commercial and Medicare Supplemental Database between November 2014 and December 2018 who had atopy, obesity, or depression/anxiety in addition to asthma and were receiving mepolizumab. Atopy in the study was defined as allergic rhinitis, anaphylaxis, atopic dermatitis, conjunctivitis, eosinophilic esophagitis, and food allergies. Patients were at least age 12 years, had at least one diagnosis for asthma, at least one diagnosis code for atopic disease, obesity, or depression/anxiety at baseline, and at least two administrations of mepolizumab within 180 days.
The researchers examined the number of exacerbations, oral corticosteroid (OCS) claims, and OCS bursts per year at 12-month follow-up, compared with baseline. They identified exacerbations by examining patients who had an emergency department or outpatient claim related to their asthma, and a claim for systemic corticosteroids made in the 4 days prior to or 5 days after a visit, or if their inpatient hospital admission contained a primary asthma diagnosis. Dr. Casale and colleagues measured OCS bursts as a pharmacy claim of at least 20 mg of prednisone per day for between 3 and 28 days plus a claim for an emergency department visit related to asthma in the 7 days prior or 6 days after the claim.
At baseline, patients across all groups were mean age 50.5-52.4 years with a Charleson Comorbidity Index score between 1.1 and 1.4, a majority were women (59.0%-72.0%) and nearly all were commercially insured (88.0%-90.0%). Patients who used biologics at baseline and/or used a biologic that wasn’t mepolizumab during the follow-up period were excluded.
Medication claims in the groups included inhaled corticosteroids (ICS) (36.8%-48.6%), ICS/long-acting beta-agonist (LABA) (60.2%-63.0%), LABA/ long-acting muscarinic antagonist (LAMA) (1.2%-3.5%), ICS/LABA/LAMA (21.2%-25.1%), short-acting beta-agonist (SABA) (83.2%-87.7%), LAMA alone (33.5%-42.1%), or leukotriene receptor antagonist (LTRA).
In the non–mutually exclusive group of patients with atopy (468 patients), 28.0% had comorbid obesity and 26.0% had comorbid depression/anxiety. For patients with obesity categorized in a non–mutually exclusive subgroup (171 patients), 79.0% had comorbid atopy and 32.0% had comorbid depression/anxiety. Among patients with non–mutually exclusive depression/anxiety (173 patients), 70.0% had comorbid atopy, while 32.0% had comorbid obesity.
The results showed the mean number of overall exacerbations decreased by 48% at 12 months in the atopic group (2.3 vs. 1.2; P < .001), 52% in the group with obesity (2.5 vs. 1.2; P < .001), and 38% in the depression/anxiety group (2.4 vs. 1.5; P < .001). The mean number of exacerbations leading to hospitalizations decreased by 64% in the atopic group (0.11 vs. 0.04; P < .001), 65% in the group with obesity (0.20 vs. 0.07; P < .001), and 68% in the group with depression/anxiety (0.22 vs. 0.07; P < .001).
The researchers also found the mean number of OCS claims and OCS bursts also significantly decreased over the 12-month follow-up period. Mean OCS claims decreased by 33% for patients in the atopic group (5.5 vs. 3.7; P < .001), by 38% in the group with obesity (6.1 vs. 3.8; P < .001), and by 31% in the group with depression/anxiety (6.2 vs. 4.3; P < .001).
The mean number of OCS bursts also significantly decreased by 40% in the atopic group (2.0 vs. 2.1; P < .001), 48% in the group with obesity (2.3 vs. 1.2; P < .001), and by 37% in the group with depression/anxiety (1.9 vs. 1.2; P < .001). In total, 69% of patients with comorbid atopy, 70.8% of patients with comorbid obesity, and 68.2% of patients with comorbid depression/anxiety experienced a mean decrease in their OCS dose over 12 months.
“These data demonstrate that patients with asthma and atopy, obesity, or depression and anxiety have significantly fewer exacerbations and reduced OCS use in a real-world setting with treatment of mepolizumab,” Dr. Casale said. “Thus, holistic patient care for severe asthma is critical, and mepolizumab provides tangible clinical benefit despite the complexities of medical comorbidities.”
This study was funded by GlaxoSmithKline, and the company also funded graphic design support of the poster. Dr. Casale reports he has received research funds from GlaxoSmithKline. Four authors report being current or former GlaxoSmithKline employees; three authors report holding stock and/or shares of GlaxoSmithKline. Three authors are IBM Watson Health employees, a company GlaxoSmithKline has provided research funding.
, according to research from the annual meeting of the American Academy of Allergy, Asthma, and Immunology.
“Mepolizumab has clearly been shown to improve severe asthma control in many clinical trials, but atopy, obesity, and depression/anxiety affect patients with asthma at an increased rate,” Thomas B. Casale, MD, former AAAAI president and professor of medicine and pediatrics at the University of South Florida in Tampa, said in a presentation at the meeting. “Yet, few studies have examined whether asthma therapy with these comorbidities works.”
Dr. Casale and colleagues performed a retrospective analysis of patients in the United States from the MarketScan Commercial and Medicare Supplemental Database between November 2014 and December 2018 who had atopy, obesity, or depression/anxiety in addition to asthma and were receiving mepolizumab. Atopy in the study was defined as allergic rhinitis, anaphylaxis, atopic dermatitis, conjunctivitis, eosinophilic esophagitis, and food allergies. Patients were at least age 12 years, had at least one diagnosis for asthma, at least one diagnosis code for atopic disease, obesity, or depression/anxiety at baseline, and at least two administrations of mepolizumab within 180 days.
The researchers examined the number of exacerbations, oral corticosteroid (OCS) claims, and OCS bursts per year at 12-month follow-up, compared with baseline. They identified exacerbations by examining patients who had an emergency department or outpatient claim related to their asthma, and a claim for systemic corticosteroids made in the 4 days prior to or 5 days after a visit, or if their inpatient hospital admission contained a primary asthma diagnosis. Dr. Casale and colleagues measured OCS bursts as a pharmacy claim of at least 20 mg of prednisone per day for between 3 and 28 days plus a claim for an emergency department visit related to asthma in the 7 days prior or 6 days after the claim.
At baseline, patients across all groups were mean age 50.5-52.4 years with a Charleson Comorbidity Index score between 1.1 and 1.4, a majority were women (59.0%-72.0%) and nearly all were commercially insured (88.0%-90.0%). Patients who used biologics at baseline and/or used a biologic that wasn’t mepolizumab during the follow-up period were excluded.
Medication claims in the groups included inhaled corticosteroids (ICS) (36.8%-48.6%), ICS/long-acting beta-agonist (LABA) (60.2%-63.0%), LABA/ long-acting muscarinic antagonist (LAMA) (1.2%-3.5%), ICS/LABA/LAMA (21.2%-25.1%), short-acting beta-agonist (SABA) (83.2%-87.7%), LAMA alone (33.5%-42.1%), or leukotriene receptor antagonist (LTRA).
In the non–mutually exclusive group of patients with atopy (468 patients), 28.0% had comorbid obesity and 26.0% had comorbid depression/anxiety. For patients with obesity categorized in a non–mutually exclusive subgroup (171 patients), 79.0% had comorbid atopy and 32.0% had comorbid depression/anxiety. Among patients with non–mutually exclusive depression/anxiety (173 patients), 70.0% had comorbid atopy, while 32.0% had comorbid obesity.
The results showed the mean number of overall exacerbations decreased by 48% at 12 months in the atopic group (2.3 vs. 1.2; P < .001), 52% in the group with obesity (2.5 vs. 1.2; P < .001), and 38% in the depression/anxiety group (2.4 vs. 1.5; P < .001). The mean number of exacerbations leading to hospitalizations decreased by 64% in the atopic group (0.11 vs. 0.04; P < .001), 65% in the group with obesity (0.20 vs. 0.07; P < .001), and 68% in the group with depression/anxiety (0.22 vs. 0.07; P < .001).
The researchers also found the mean number of OCS claims and OCS bursts also significantly decreased over the 12-month follow-up period. Mean OCS claims decreased by 33% for patients in the atopic group (5.5 vs. 3.7; P < .001), by 38% in the group with obesity (6.1 vs. 3.8; P < .001), and by 31% in the group with depression/anxiety (6.2 vs. 4.3; P < .001).
The mean number of OCS bursts also significantly decreased by 40% in the atopic group (2.0 vs. 2.1; P < .001), 48% in the group with obesity (2.3 vs. 1.2; P < .001), and by 37% in the group with depression/anxiety (1.9 vs. 1.2; P < .001). In total, 69% of patients with comorbid atopy, 70.8% of patients with comorbid obesity, and 68.2% of patients with comorbid depression/anxiety experienced a mean decrease in their OCS dose over 12 months.
“These data demonstrate that patients with asthma and atopy, obesity, or depression and anxiety have significantly fewer exacerbations and reduced OCS use in a real-world setting with treatment of mepolizumab,” Dr. Casale said. “Thus, holistic patient care for severe asthma is critical, and mepolizumab provides tangible clinical benefit despite the complexities of medical comorbidities.”
This study was funded by GlaxoSmithKline, and the company also funded graphic design support of the poster. Dr. Casale reports he has received research funds from GlaxoSmithKline. Four authors report being current or former GlaxoSmithKline employees; three authors report holding stock and/or shares of GlaxoSmithKline. Three authors are IBM Watson Health employees, a company GlaxoSmithKline has provided research funding.
FROM AAAAI 2021
Opioid use common for pain in multiple sclerosis
, new research shows.
“This high level of opioid use supports that better pain management treatment options, including nonpharmacological options, are needed for people with MS and pain,” wrote the authors of the study, which was presented at ACTRIMS Forum 2021, held by the Americas Committee for Treatment and Research in Multiple Sclerosis.
Previous research has shown that more than 50% of people with MS report chronic pain that is serious enough to interfere with daily activities, employment, and quality of life. Many with MS report that pain is one of their worst symptoms, the authors noted.
With surprisingly few studies evaluating opioid use in the MS population, Cinda L. Hugos, PT, associate professor of neurology with the VA Portland Health Care System and the department of neurology, Oregon Health and Science University, Portland, and colleagues investigated the issue in a sample of patients participating in a U.S. multisite MS fatigue management trial conducted between 2013 and 2014.
Of the 281 participants with MS in the study, 58 patients (20.6%) reported using prescription opioids. Among them, most – 44 (76%) – reported regular daily use, 10 (17%) reported using the drugs only as needed, 3 (5%) reported only short-term use, including after recent injury or dental surgery, and 1 provided incomplete information.
Those who reported opioid use had significantly worse fatigue scores on the Modified Fatigue Impact Scale (P = .015) and worse pain scores (P < .0001).
There were no significant differences in terms of age (mean age, 53 years), gender (69% were female), or race (in both groups, about 76% were White). No significant differences were seen in disability or depression scores in the opioid users versus nonusers.
“In this sample of people with multiple sclerosis who self-reported fatigue and volunteered to join an MS fatigue management research study, more than one in five reported using prescription opioids and nearly one in six used opioids daily,” the authors wrote. “Opioid users had more pain and fatigue than nonusers.”
Commenting on the study, Jeffrey Cohen, MD, president of ACTRIMS, said that the findings are consistent with his observations that “in the general population, opioids often are used to treat chronic pain in people with MS.”
But they’re not getting the drugs from his clinic. “We do not prescribe opioids in our clinic, referring such patients to a chronic pain program,” Dr. Cohen said. “However, there clearly is need for better treatment options.”
A previous study on opioid use by people with MS, published in 2015, found even higher rates – 42% reported having ever used opioids, and 38% reported currently using opioids.
Although reports of opioid use by patients with MS have been lacking, more has been published on the emerging use of cannabis-related products. One recent study showed that nearly half of people with MS reported using a cannabis-based therapy for nerve-based pain and sleep disturbances.
Although cannabis is considered safer than opioids, the authors noted that it has its own significant drawback – a “paucity of provider guidance.”
“The range of perceived benefits and potential differential effects of THC and cannabinoid highlight the need for personalized, evidence-based guidelines regarding cannabinoid use,” they wrote.
Stretching program for spasticity shows benefits
With spasticity representing a key contributor to MS pain and affecting more than 80% of people with MS, Ms. Hugos and colleagues are developing an alternative to medication – a nonpharmacologic stretching regimen called Spasticity: Take Control” (STC).
Based on evidence-based strategies for the treatment of spasticity in MS, the program involves exercises with daily routines of 15-20 minutes over 6 months.
In a pilot study of 66 patients, also presented at the ACTRIMS meeting, the investigators reported that the program showed significant reductions in pain severity and interference, measured with the Brief Pain Inventory–Short Form, compared with a control consisting of range of motion instruction over 6 months.
The study also offered insights on the specific areas of pain. Among those who reported chronic pain (42% in the STC group and 63.3% in the range-of-motion group), the pain was most frequently reported in the lower back (74.3%), legs (68.6%), or lower back and legs (88.6%).
Ms. Hugos noted that the findings suggest a potentially important nonpharmacologic alternative to spasticity-related pain in MS.
“Stretching is the cornerstone treatment for spasticity from all causes, but there is very little information on stretching exercises in MS or any other conditions,” Ms. Hugos said. “[Our] pilot study is the first and only study using a standardized, daily stretching exercise program to treat MS spasticity,” she said.
“A fully powered study is needed to better understand the impact of different types of exercise on pain severity and interference in multiple sclerosis,” she noted.
Ms. Hugos has received consulting fees from Greenwich Biosciences, Evidera, and Techspert.io. Dr. Cohen has received personal compensation for consulting for Adamas, Atara, Bristol-Myers Squibb, Convelo, MedDay, and Mylan.
A version of this article first appeared on Medscape.com.
, new research shows.
“This high level of opioid use supports that better pain management treatment options, including nonpharmacological options, are needed for people with MS and pain,” wrote the authors of the study, which was presented at ACTRIMS Forum 2021, held by the Americas Committee for Treatment and Research in Multiple Sclerosis.
Previous research has shown that more than 50% of people with MS report chronic pain that is serious enough to interfere with daily activities, employment, and quality of life. Many with MS report that pain is one of their worst symptoms, the authors noted.
With surprisingly few studies evaluating opioid use in the MS population, Cinda L. Hugos, PT, associate professor of neurology with the VA Portland Health Care System and the department of neurology, Oregon Health and Science University, Portland, and colleagues investigated the issue in a sample of patients participating in a U.S. multisite MS fatigue management trial conducted between 2013 and 2014.
Of the 281 participants with MS in the study, 58 patients (20.6%) reported using prescription opioids. Among them, most – 44 (76%) – reported regular daily use, 10 (17%) reported using the drugs only as needed, 3 (5%) reported only short-term use, including after recent injury or dental surgery, and 1 provided incomplete information.
Those who reported opioid use had significantly worse fatigue scores on the Modified Fatigue Impact Scale (P = .015) and worse pain scores (P < .0001).
There were no significant differences in terms of age (mean age, 53 years), gender (69% were female), or race (in both groups, about 76% were White). No significant differences were seen in disability or depression scores in the opioid users versus nonusers.
“In this sample of people with multiple sclerosis who self-reported fatigue and volunteered to join an MS fatigue management research study, more than one in five reported using prescription opioids and nearly one in six used opioids daily,” the authors wrote. “Opioid users had more pain and fatigue than nonusers.”
Commenting on the study, Jeffrey Cohen, MD, president of ACTRIMS, said that the findings are consistent with his observations that “in the general population, opioids often are used to treat chronic pain in people with MS.”
But they’re not getting the drugs from his clinic. “We do not prescribe opioids in our clinic, referring such patients to a chronic pain program,” Dr. Cohen said. “However, there clearly is need for better treatment options.”
A previous study on opioid use by people with MS, published in 2015, found even higher rates – 42% reported having ever used opioids, and 38% reported currently using opioids.
Although reports of opioid use by patients with MS have been lacking, more has been published on the emerging use of cannabis-related products. One recent study showed that nearly half of people with MS reported using a cannabis-based therapy for nerve-based pain and sleep disturbances.
Although cannabis is considered safer than opioids, the authors noted that it has its own significant drawback – a “paucity of provider guidance.”
“The range of perceived benefits and potential differential effects of THC and cannabinoid highlight the need for personalized, evidence-based guidelines regarding cannabinoid use,” they wrote.
Stretching program for spasticity shows benefits
With spasticity representing a key contributor to MS pain and affecting more than 80% of people with MS, Ms. Hugos and colleagues are developing an alternative to medication – a nonpharmacologic stretching regimen called Spasticity: Take Control” (STC).
Based on evidence-based strategies for the treatment of spasticity in MS, the program involves exercises with daily routines of 15-20 minutes over 6 months.
In a pilot study of 66 patients, also presented at the ACTRIMS meeting, the investigators reported that the program showed significant reductions in pain severity and interference, measured with the Brief Pain Inventory–Short Form, compared with a control consisting of range of motion instruction over 6 months.
The study also offered insights on the specific areas of pain. Among those who reported chronic pain (42% in the STC group and 63.3% in the range-of-motion group), the pain was most frequently reported in the lower back (74.3%), legs (68.6%), or lower back and legs (88.6%).
Ms. Hugos noted that the findings suggest a potentially important nonpharmacologic alternative to spasticity-related pain in MS.
“Stretching is the cornerstone treatment for spasticity from all causes, but there is very little information on stretching exercises in MS or any other conditions,” Ms. Hugos said. “[Our] pilot study is the first and only study using a standardized, daily stretching exercise program to treat MS spasticity,” she said.
“A fully powered study is needed to better understand the impact of different types of exercise on pain severity and interference in multiple sclerosis,” she noted.
Ms. Hugos has received consulting fees from Greenwich Biosciences, Evidera, and Techspert.io. Dr. Cohen has received personal compensation for consulting for Adamas, Atara, Bristol-Myers Squibb, Convelo, MedDay, and Mylan.
A version of this article first appeared on Medscape.com.
, new research shows.
“This high level of opioid use supports that better pain management treatment options, including nonpharmacological options, are needed for people with MS and pain,” wrote the authors of the study, which was presented at ACTRIMS Forum 2021, held by the Americas Committee for Treatment and Research in Multiple Sclerosis.
Previous research has shown that more than 50% of people with MS report chronic pain that is serious enough to interfere with daily activities, employment, and quality of life. Many with MS report that pain is one of their worst symptoms, the authors noted.
With surprisingly few studies evaluating opioid use in the MS population, Cinda L. Hugos, PT, associate professor of neurology with the VA Portland Health Care System and the department of neurology, Oregon Health and Science University, Portland, and colleagues investigated the issue in a sample of patients participating in a U.S. multisite MS fatigue management trial conducted between 2013 and 2014.
Of the 281 participants with MS in the study, 58 patients (20.6%) reported using prescription opioids. Among them, most – 44 (76%) – reported regular daily use, 10 (17%) reported using the drugs only as needed, 3 (5%) reported only short-term use, including after recent injury or dental surgery, and 1 provided incomplete information.
Those who reported opioid use had significantly worse fatigue scores on the Modified Fatigue Impact Scale (P = .015) and worse pain scores (P < .0001).
There were no significant differences in terms of age (mean age, 53 years), gender (69% were female), or race (in both groups, about 76% were White). No significant differences were seen in disability or depression scores in the opioid users versus nonusers.
“In this sample of people with multiple sclerosis who self-reported fatigue and volunteered to join an MS fatigue management research study, more than one in five reported using prescription opioids and nearly one in six used opioids daily,” the authors wrote. “Opioid users had more pain and fatigue than nonusers.”
Commenting on the study, Jeffrey Cohen, MD, president of ACTRIMS, said that the findings are consistent with his observations that “in the general population, opioids often are used to treat chronic pain in people with MS.”
But they’re not getting the drugs from his clinic. “We do not prescribe opioids in our clinic, referring such patients to a chronic pain program,” Dr. Cohen said. “However, there clearly is need for better treatment options.”
A previous study on opioid use by people with MS, published in 2015, found even higher rates – 42% reported having ever used opioids, and 38% reported currently using opioids.
Although reports of opioid use by patients with MS have been lacking, more has been published on the emerging use of cannabis-related products. One recent study showed that nearly half of people with MS reported using a cannabis-based therapy for nerve-based pain and sleep disturbances.
Although cannabis is considered safer than opioids, the authors noted that it has its own significant drawback – a “paucity of provider guidance.”
“The range of perceived benefits and potential differential effects of THC and cannabinoid highlight the need for personalized, evidence-based guidelines regarding cannabinoid use,” they wrote.
Stretching program for spasticity shows benefits
With spasticity representing a key contributor to MS pain and affecting more than 80% of people with MS, Ms. Hugos and colleagues are developing an alternative to medication – a nonpharmacologic stretching regimen called Spasticity: Take Control” (STC).
Based on evidence-based strategies for the treatment of spasticity in MS, the program involves exercises with daily routines of 15-20 minutes over 6 months.
In a pilot study of 66 patients, also presented at the ACTRIMS meeting, the investigators reported that the program showed significant reductions in pain severity and interference, measured with the Brief Pain Inventory–Short Form, compared with a control consisting of range of motion instruction over 6 months.
The study also offered insights on the specific areas of pain. Among those who reported chronic pain (42% in the STC group and 63.3% in the range-of-motion group), the pain was most frequently reported in the lower back (74.3%), legs (68.6%), or lower back and legs (88.6%).
Ms. Hugos noted that the findings suggest a potentially important nonpharmacologic alternative to spasticity-related pain in MS.
“Stretching is the cornerstone treatment for spasticity from all causes, but there is very little information on stretching exercises in MS or any other conditions,” Ms. Hugos said. “[Our] pilot study is the first and only study using a standardized, daily stretching exercise program to treat MS spasticity,” she said.
“A fully powered study is needed to better understand the impact of different types of exercise on pain severity and interference in multiple sclerosis,” she noted.
Ms. Hugos has received consulting fees from Greenwich Biosciences, Evidera, and Techspert.io. Dr. Cohen has received personal compensation for consulting for Adamas, Atara, Bristol-Myers Squibb, Convelo, MedDay, and Mylan.
A version of this article first appeared on Medscape.com.
FROM ACTRIMS FORUM 2021
Neurologic disorders ubiquitous and rising in the U.S.
, according to new findings derived from the 2017 Global Burden of Disease study.
The authors of the analysis, led by Valery Feigin, MD, PhD, of New Zealand’s National Institute for Stroke and Applied Neurosciences, and published in the February 2021 issue of JAMA Neurology, looked at prevalence, incidence, mortality, and disability-adjusted life years for 14 neurological disorders across 50 states between 1990 and 2017. The diseases included in the analysis were stroke, Alzheimer’s disease and other dementias, Parkinson’s disease, epilepsy, multiple sclerosis, motor neuron disease, headaches, traumatic brain injury, spinal cord injuries, brain and other nervous system cancers, meningitis, encephalitis, and tetanus.
Tracking the burden of neurologic diseases
Dr. Feigin and colleagues estimated that a full 60% of the U.S. population lives with one or more of these disorders, a figure much greater than previous estimates for neurological disease burden nationwide. Tension-type headache and migraine were the most prevalent in the analysis by Dr. Feigin and colleagues. During the study period, they found, prevalence, incidence, and disability burden of nearly all the included disorders increased, with the exception of brain and spinal cord injuries, meningitis, and encephalitis.
The researchers attributed most of the rise in noncommunicable neurological diseases to population aging. An age-standardized analysis found trends for stroke and Alzheimer’s disease and other dementias to be declining or flat. Age-standardized stroke incidence dropped by 16% from 1990 to 2017, while stroke mortality declined by nearly a third, and stroke disability by a quarter. Age-standardized incidence of Alzheimer’s disease and other dementias dropped by 12%, and their prevalence by 13%, during the study period, though dementia mortality and disability were seen increasing.
The authors surmised that the age-standardized declines in stroke and dementias could reflect that “primary prevention of these disorders are beginning to show an influence.” With dementia, which is linked to cognitive reserve and education, “improving educational levels of cohort reaching the age groups at greatest risk of disease may also be contributing to a modest decline over time,” Dr. Feigin and his colleagues wrote.
Parkinson’s disease and multiple sclerosis, meanwhile, were both seen rising in incidence, prevalence, and disability adjusted life years (DALYs) even with age-standardized figures. The United States saw comparatively more disability in 2017 from dementias, Parkinson’s disease, epilepsy, multiple sclerosis, motor neuron disease, and headache disorders, which together comprised 6.7% of DALYs, compared with 4.4% globally; these also accounted for a higher share of mortality in the U.S. than worldwide. The authors attributed at least some of the difference to better case ascertainment in the U.S.
Regional variations
The researchers also reported variations in disease burden by state and region. While previous studies have identified a “stroke belt” concentrated in North Carolina, South Carolina, and Georgia, the new findings point to stroke disability highest in Alabama, Arkansas, and Mississippi, and mortality highest in Alabama, Mississippi, and South Carolina. The researchers noted increases in dementia mortality in these states, “likely attributable to the reciprocal association between stroke and dementia.”
Northern states saw higher burdens of multiple sclerosis compared with the rest of the country, while eastern states had higher rates of Parkinson’s disease.
Such regional and state-by state variations, Dr. Feigin and colleagues wrote in their analysis, “may be associated with differences in the case ascertainment, as well as access to health care; racial/ethnic, genetic, and socioeconomic diversity; quality and comprehensiveness of preventive strategies; and risk factor distribution.”
The researchers noted as a limitation of their study that the 14 diseases captured were not an exhaustive list of neurological conditions; chronic lower back pain, a condition included in a previous major study of the burden of neurological disease in the United States, was omitted, as were restless legs syndrome and peripheral neuropathy. The researchers cited changes to coding practice in the U.S. and accuracy of medical claims data as potential limitations of their analysis. The Global Burden of Disease study is funded by the Bill and Melinda Gates Foundation, and several of Dr. Feigin’s coauthors reported financial relationships with industry.
Time to adjust the stroke belt?
Amelia Boehme, PhD, a stroke epidemiologist at Columbia University Mailman School of Public Health in New York, said in an interview that the current study added to recent findings showing surprising local variability in stroke prevalence, incidence, and mortality. “What we had always conceptually thought of as the ‘stroke belt’ isn’t necessarily the case,” Dr. Boehme said, but is rather subject to local, county-by-county variations. “Looking at the data here in conjunction with what previous authors have found, it raises some questions as to whether or not state-level data is giving a completely accurate picture, and whether we need to start looking at the county level and adjust for populations and age.” Importantly, Dr. Boehme said, data collected in the Global Burden of Disease study tends to be exceptionally rigorous and systematic, adding weight to Dr. Feigin and colleagues’ suggestions that prevention efforts may be making a dent in stroke and dementia.
“More data is always needed before we start to say we’re seeing things change,” Dr. Boehme noted. “But any glimmer of optimism is welcome, especially with regard to interventions that have been put in place, to allow us to build on those interventions.”
Dr. Boehme disclosed no financial conflicts of interest.
, according to new findings derived from the 2017 Global Burden of Disease study.
The authors of the analysis, led by Valery Feigin, MD, PhD, of New Zealand’s National Institute for Stroke and Applied Neurosciences, and published in the February 2021 issue of JAMA Neurology, looked at prevalence, incidence, mortality, and disability-adjusted life years for 14 neurological disorders across 50 states between 1990 and 2017. The diseases included in the analysis were stroke, Alzheimer’s disease and other dementias, Parkinson’s disease, epilepsy, multiple sclerosis, motor neuron disease, headaches, traumatic brain injury, spinal cord injuries, brain and other nervous system cancers, meningitis, encephalitis, and tetanus.
Tracking the burden of neurologic diseases
Dr. Feigin and colleagues estimated that a full 60% of the U.S. population lives with one or more of these disorders, a figure much greater than previous estimates for neurological disease burden nationwide. Tension-type headache and migraine were the most prevalent in the analysis by Dr. Feigin and colleagues. During the study period, they found, prevalence, incidence, and disability burden of nearly all the included disorders increased, with the exception of brain and spinal cord injuries, meningitis, and encephalitis.
The researchers attributed most of the rise in noncommunicable neurological diseases to population aging. An age-standardized analysis found trends for stroke and Alzheimer’s disease and other dementias to be declining or flat. Age-standardized stroke incidence dropped by 16% from 1990 to 2017, while stroke mortality declined by nearly a third, and stroke disability by a quarter. Age-standardized incidence of Alzheimer’s disease and other dementias dropped by 12%, and their prevalence by 13%, during the study period, though dementia mortality and disability were seen increasing.
The authors surmised that the age-standardized declines in stroke and dementias could reflect that “primary prevention of these disorders are beginning to show an influence.” With dementia, which is linked to cognitive reserve and education, “improving educational levels of cohort reaching the age groups at greatest risk of disease may also be contributing to a modest decline over time,” Dr. Feigin and his colleagues wrote.
Parkinson’s disease and multiple sclerosis, meanwhile, were both seen rising in incidence, prevalence, and disability adjusted life years (DALYs) even with age-standardized figures. The United States saw comparatively more disability in 2017 from dementias, Parkinson’s disease, epilepsy, multiple sclerosis, motor neuron disease, and headache disorders, which together comprised 6.7% of DALYs, compared with 4.4% globally; these also accounted for a higher share of mortality in the U.S. than worldwide. The authors attributed at least some of the difference to better case ascertainment in the U.S.
Regional variations
The researchers also reported variations in disease burden by state and region. While previous studies have identified a “stroke belt” concentrated in North Carolina, South Carolina, and Georgia, the new findings point to stroke disability highest in Alabama, Arkansas, and Mississippi, and mortality highest in Alabama, Mississippi, and South Carolina. The researchers noted increases in dementia mortality in these states, “likely attributable to the reciprocal association between stroke and dementia.”
Northern states saw higher burdens of multiple sclerosis compared with the rest of the country, while eastern states had higher rates of Parkinson’s disease.
Such regional and state-by state variations, Dr. Feigin and colleagues wrote in their analysis, “may be associated with differences in the case ascertainment, as well as access to health care; racial/ethnic, genetic, and socioeconomic diversity; quality and comprehensiveness of preventive strategies; and risk factor distribution.”
The researchers noted as a limitation of their study that the 14 diseases captured were not an exhaustive list of neurological conditions; chronic lower back pain, a condition included in a previous major study of the burden of neurological disease in the United States, was omitted, as were restless legs syndrome and peripheral neuropathy. The researchers cited changes to coding practice in the U.S. and accuracy of medical claims data as potential limitations of their analysis. The Global Burden of Disease study is funded by the Bill and Melinda Gates Foundation, and several of Dr. Feigin’s coauthors reported financial relationships with industry.
Time to adjust the stroke belt?
Amelia Boehme, PhD, a stroke epidemiologist at Columbia University Mailman School of Public Health in New York, said in an interview that the current study added to recent findings showing surprising local variability in stroke prevalence, incidence, and mortality. “What we had always conceptually thought of as the ‘stroke belt’ isn’t necessarily the case,” Dr. Boehme said, but is rather subject to local, county-by-county variations. “Looking at the data here in conjunction with what previous authors have found, it raises some questions as to whether or not state-level data is giving a completely accurate picture, and whether we need to start looking at the county level and adjust for populations and age.” Importantly, Dr. Boehme said, data collected in the Global Burden of Disease study tends to be exceptionally rigorous and systematic, adding weight to Dr. Feigin and colleagues’ suggestions that prevention efforts may be making a dent in stroke and dementia.
“More data is always needed before we start to say we’re seeing things change,” Dr. Boehme noted. “But any glimmer of optimism is welcome, especially with regard to interventions that have been put in place, to allow us to build on those interventions.”
Dr. Boehme disclosed no financial conflicts of interest.
, according to new findings derived from the 2017 Global Burden of Disease study.
The authors of the analysis, led by Valery Feigin, MD, PhD, of New Zealand’s National Institute for Stroke and Applied Neurosciences, and published in the February 2021 issue of JAMA Neurology, looked at prevalence, incidence, mortality, and disability-adjusted life years for 14 neurological disorders across 50 states between 1990 and 2017. The diseases included in the analysis were stroke, Alzheimer’s disease and other dementias, Parkinson’s disease, epilepsy, multiple sclerosis, motor neuron disease, headaches, traumatic brain injury, spinal cord injuries, brain and other nervous system cancers, meningitis, encephalitis, and tetanus.
Tracking the burden of neurologic diseases
Dr. Feigin and colleagues estimated that a full 60% of the U.S. population lives with one or more of these disorders, a figure much greater than previous estimates for neurological disease burden nationwide. Tension-type headache and migraine were the most prevalent in the analysis by Dr. Feigin and colleagues. During the study period, they found, prevalence, incidence, and disability burden of nearly all the included disorders increased, with the exception of brain and spinal cord injuries, meningitis, and encephalitis.
The researchers attributed most of the rise in noncommunicable neurological diseases to population aging. An age-standardized analysis found trends for stroke and Alzheimer’s disease and other dementias to be declining or flat. Age-standardized stroke incidence dropped by 16% from 1990 to 2017, while stroke mortality declined by nearly a third, and stroke disability by a quarter. Age-standardized incidence of Alzheimer’s disease and other dementias dropped by 12%, and their prevalence by 13%, during the study period, though dementia mortality and disability were seen increasing.
The authors surmised that the age-standardized declines in stroke and dementias could reflect that “primary prevention of these disorders are beginning to show an influence.” With dementia, which is linked to cognitive reserve and education, “improving educational levels of cohort reaching the age groups at greatest risk of disease may also be contributing to a modest decline over time,” Dr. Feigin and his colleagues wrote.
Parkinson’s disease and multiple sclerosis, meanwhile, were both seen rising in incidence, prevalence, and disability adjusted life years (DALYs) even with age-standardized figures. The United States saw comparatively more disability in 2017 from dementias, Parkinson’s disease, epilepsy, multiple sclerosis, motor neuron disease, and headache disorders, which together comprised 6.7% of DALYs, compared with 4.4% globally; these also accounted for a higher share of mortality in the U.S. than worldwide. The authors attributed at least some of the difference to better case ascertainment in the U.S.
Regional variations
The researchers also reported variations in disease burden by state and region. While previous studies have identified a “stroke belt” concentrated in North Carolina, South Carolina, and Georgia, the new findings point to stroke disability highest in Alabama, Arkansas, and Mississippi, and mortality highest in Alabama, Mississippi, and South Carolina. The researchers noted increases in dementia mortality in these states, “likely attributable to the reciprocal association between stroke and dementia.”
Northern states saw higher burdens of multiple sclerosis compared with the rest of the country, while eastern states had higher rates of Parkinson’s disease.
Such regional and state-by state variations, Dr. Feigin and colleagues wrote in their analysis, “may be associated with differences in the case ascertainment, as well as access to health care; racial/ethnic, genetic, and socioeconomic diversity; quality and comprehensiveness of preventive strategies; and risk factor distribution.”
The researchers noted as a limitation of their study that the 14 diseases captured were not an exhaustive list of neurological conditions; chronic lower back pain, a condition included in a previous major study of the burden of neurological disease in the United States, was omitted, as were restless legs syndrome and peripheral neuropathy. The researchers cited changes to coding practice in the U.S. and accuracy of medical claims data as potential limitations of their analysis. The Global Burden of Disease study is funded by the Bill and Melinda Gates Foundation, and several of Dr. Feigin’s coauthors reported financial relationships with industry.
Time to adjust the stroke belt?
Amelia Boehme, PhD, a stroke epidemiologist at Columbia University Mailman School of Public Health in New York, said in an interview that the current study added to recent findings showing surprising local variability in stroke prevalence, incidence, and mortality. “What we had always conceptually thought of as the ‘stroke belt’ isn’t necessarily the case,” Dr. Boehme said, but is rather subject to local, county-by-county variations. “Looking at the data here in conjunction with what previous authors have found, it raises some questions as to whether or not state-level data is giving a completely accurate picture, and whether we need to start looking at the county level and adjust for populations and age.” Importantly, Dr. Boehme said, data collected in the Global Burden of Disease study tends to be exceptionally rigorous and systematic, adding weight to Dr. Feigin and colleagues’ suggestions that prevention efforts may be making a dent in stroke and dementia.
“More data is always needed before we start to say we’re seeing things change,” Dr. Boehme noted. “But any glimmer of optimism is welcome, especially with regard to interventions that have been put in place, to allow us to build on those interventions.”
Dr. Boehme disclosed no financial conflicts of interest.
FROM JAMA NEUROLOGY
Adalimumab earns FDA approval for ulcerative colitis in children
Adalimumab has received approval from the Food and Drug Administration for use in pediatric patients aged 5 years and older with moderately to severely active ulcerative colitis (UC), according to a press release from manufacturer AbbVie.
Approval was based on data from the phase 3 ENVISION 1 randomized, double-blind study (NCT02065557) in which 60% of patients receiving the higher induction dose showed clinical remission according to Partial May Score (PMS) at 8 weeks, 45% of whom were in remission according to Full Mayo Score (FMS) at 1 year. The approval means that children with UC and their families have the option of a subcutaneous biologic that can be administered at home.
In the ENVISION 1 study, clinical remission was defined as a PMS (based on stool frequency, rectal bleeding, and physician’s global assessment) ranging from 0 to 3 at the end of the 8-week induction period or FMS (which adds endoscopy) at the end of 52 weeks as less than or equal to 2 points total, with no individual subscore greater than 1. The study included children aged 4-17 years with active UC who were randomized to a low-dose or high-dose group.
“Through week 8, patients in both dosage groups received 2.4 mg/kg (maximum of 160 mg) at week 0, 1.2 mg/kg (maximum of 80 mg) at week 2, and 0.6 mg/kg (maximum of 40 mg) at weeks 4 and 6. The higher-dosage group also received an additional dosage of 2.4 mg/kg (maximum of 160 mg) at week 1,” according to the company press release. Between weeks 8 and 52, patients received double-blind placebo or 0.6 mg/kg adalimumab (maximum of 40 mg) every other week (maintenance standard dose) or every week (maintenance high dose).
No new adalimumab safety signals were noted in the study; headache and worsening UC were the most frequently reported treatment-emergent adverse events, and 22.6% of patients experienced a serious adverse event. “No deaths, malignancies, active tuberculosis or demyelinating disease were observed in this study,” according to the company. Full prescribing information can be found on the FDA website.
Approval expands options
“The number of FDA-approved biologics to treat pediatric UC has been limited,” said Atsushi Sakuraba, MD, PhD, an inflammatory bowel disease specialist at the University of Chicago, in an interview. “Infliximab is approved for pediatric UC and CD [Crohn’s disease], but adalimumab was only approved for CD in pediatric patients, and vedolizumab and ustekinumab are approved for neither UC nor CD in pediatric patients,” he said. “Thus, the addition of adalimumab as a treatment option for pediatric UC is of great benefit for pediatricians and patients.”
The approval will impact clinical practice in several ways, Dr. Sakuraba said. “Adalimumab may be used for those who lose response to infliximab, but may also be used as a first-line biologic because it is self-injectable,” he emphasized. Given that adalimumab is already in use for pediatric patients with Crohn’s disease, Dr. Sakuraba said he does not see any barriers to implementation of its use for children with UC. In addition, “the potential for better disease control, reduction of disease-related complications, and improved quality of life outweighs the risk of adverse reactions,” Dr. Sakuraba said. “The news of no new safety concern in the 52-week study period further supports the safety of biologic treatment in pediatric patients,” he added.
As for additional research: “It remains to be determined whether combination therapy with an immunomodulator would be more effective than monotherapy, and also whether there are any additional risks of adverse events with the addition of immunomodulators such as long-term risk of malignancy, especially lymphoproliferative disorders,” Dr. Sakuraba noted. “Therapeutic options for pediatric [inflammatory bowel disease] are limited and lagging, compared to adult patients, so studies of non-TNF [tumor necrosis factor] biologics such vedolizumab and ustekinumab are also awaited,” he said.
Dr. Sakuraba had no financial conflicts to disclose.
This article was updated March 3, 2021.
Adalimumab has received approval from the Food and Drug Administration for use in pediatric patients aged 5 years and older with moderately to severely active ulcerative colitis (UC), according to a press release from manufacturer AbbVie.
Approval was based on data from the phase 3 ENVISION 1 randomized, double-blind study (NCT02065557) in which 60% of patients receiving the higher induction dose showed clinical remission according to Partial May Score (PMS) at 8 weeks, 45% of whom were in remission according to Full Mayo Score (FMS) at 1 year. The approval means that children with UC and their families have the option of a subcutaneous biologic that can be administered at home.
In the ENVISION 1 study, clinical remission was defined as a PMS (based on stool frequency, rectal bleeding, and physician’s global assessment) ranging from 0 to 3 at the end of the 8-week induction period or FMS (which adds endoscopy) at the end of 52 weeks as less than or equal to 2 points total, with no individual subscore greater than 1. The study included children aged 4-17 years with active UC who were randomized to a low-dose or high-dose group.
“Through week 8, patients in both dosage groups received 2.4 mg/kg (maximum of 160 mg) at week 0, 1.2 mg/kg (maximum of 80 mg) at week 2, and 0.6 mg/kg (maximum of 40 mg) at weeks 4 and 6. The higher-dosage group also received an additional dosage of 2.4 mg/kg (maximum of 160 mg) at week 1,” according to the company press release. Between weeks 8 and 52, patients received double-blind placebo or 0.6 mg/kg adalimumab (maximum of 40 mg) every other week (maintenance standard dose) or every week (maintenance high dose).
No new adalimumab safety signals were noted in the study; headache and worsening UC were the most frequently reported treatment-emergent adverse events, and 22.6% of patients experienced a serious adverse event. “No deaths, malignancies, active tuberculosis or demyelinating disease were observed in this study,” according to the company. Full prescribing information can be found on the FDA website.
Approval expands options
“The number of FDA-approved biologics to treat pediatric UC has been limited,” said Atsushi Sakuraba, MD, PhD, an inflammatory bowel disease specialist at the University of Chicago, in an interview. “Infliximab is approved for pediatric UC and CD [Crohn’s disease], but adalimumab was only approved for CD in pediatric patients, and vedolizumab and ustekinumab are approved for neither UC nor CD in pediatric patients,” he said. “Thus, the addition of adalimumab as a treatment option for pediatric UC is of great benefit for pediatricians and patients.”
The approval will impact clinical practice in several ways, Dr. Sakuraba said. “Adalimumab may be used for those who lose response to infliximab, but may also be used as a first-line biologic because it is self-injectable,” he emphasized. Given that adalimumab is already in use for pediatric patients with Crohn’s disease, Dr. Sakuraba said he does not see any barriers to implementation of its use for children with UC. In addition, “the potential for better disease control, reduction of disease-related complications, and improved quality of life outweighs the risk of adverse reactions,” Dr. Sakuraba said. “The news of no new safety concern in the 52-week study period further supports the safety of biologic treatment in pediatric patients,” he added.
As for additional research: “It remains to be determined whether combination therapy with an immunomodulator would be more effective than monotherapy, and also whether there are any additional risks of adverse events with the addition of immunomodulators such as long-term risk of malignancy, especially lymphoproliferative disorders,” Dr. Sakuraba noted. “Therapeutic options for pediatric [inflammatory bowel disease] are limited and lagging, compared to adult patients, so studies of non-TNF [tumor necrosis factor] biologics such vedolizumab and ustekinumab are also awaited,” he said.
Dr. Sakuraba had no financial conflicts to disclose.
This article was updated March 3, 2021.
Adalimumab has received approval from the Food and Drug Administration for use in pediatric patients aged 5 years and older with moderately to severely active ulcerative colitis (UC), according to a press release from manufacturer AbbVie.
Approval was based on data from the phase 3 ENVISION 1 randomized, double-blind study (NCT02065557) in which 60% of patients receiving the higher induction dose showed clinical remission according to Partial May Score (PMS) at 8 weeks, 45% of whom were in remission according to Full Mayo Score (FMS) at 1 year. The approval means that children with UC and their families have the option of a subcutaneous biologic that can be administered at home.
In the ENVISION 1 study, clinical remission was defined as a PMS (based on stool frequency, rectal bleeding, and physician’s global assessment) ranging from 0 to 3 at the end of the 8-week induction period or FMS (which adds endoscopy) at the end of 52 weeks as less than or equal to 2 points total, with no individual subscore greater than 1. The study included children aged 4-17 years with active UC who were randomized to a low-dose or high-dose group.
“Through week 8, patients in both dosage groups received 2.4 mg/kg (maximum of 160 mg) at week 0, 1.2 mg/kg (maximum of 80 mg) at week 2, and 0.6 mg/kg (maximum of 40 mg) at weeks 4 and 6. The higher-dosage group also received an additional dosage of 2.4 mg/kg (maximum of 160 mg) at week 1,” according to the company press release. Between weeks 8 and 52, patients received double-blind placebo or 0.6 mg/kg adalimumab (maximum of 40 mg) every other week (maintenance standard dose) or every week (maintenance high dose).
No new adalimumab safety signals were noted in the study; headache and worsening UC were the most frequently reported treatment-emergent adverse events, and 22.6% of patients experienced a serious adverse event. “No deaths, malignancies, active tuberculosis or demyelinating disease were observed in this study,” according to the company. Full prescribing information can be found on the FDA website.
Approval expands options
“The number of FDA-approved biologics to treat pediatric UC has been limited,” said Atsushi Sakuraba, MD, PhD, an inflammatory bowel disease specialist at the University of Chicago, in an interview. “Infliximab is approved for pediatric UC and CD [Crohn’s disease], but adalimumab was only approved for CD in pediatric patients, and vedolizumab and ustekinumab are approved for neither UC nor CD in pediatric patients,” he said. “Thus, the addition of adalimumab as a treatment option for pediatric UC is of great benefit for pediatricians and patients.”
The approval will impact clinical practice in several ways, Dr. Sakuraba said. “Adalimumab may be used for those who lose response to infliximab, but may also be used as a first-line biologic because it is self-injectable,” he emphasized. Given that adalimumab is already in use for pediatric patients with Crohn’s disease, Dr. Sakuraba said he does not see any barriers to implementation of its use for children with UC. In addition, “the potential for better disease control, reduction of disease-related complications, and improved quality of life outweighs the risk of adverse reactions,” Dr. Sakuraba said. “The news of no new safety concern in the 52-week study period further supports the safety of biologic treatment in pediatric patients,” he added.
As for additional research: “It remains to be determined whether combination therapy with an immunomodulator would be more effective than monotherapy, and also whether there are any additional risks of adverse events with the addition of immunomodulators such as long-term risk of malignancy, especially lymphoproliferative disorders,” Dr. Sakuraba noted. “Therapeutic options for pediatric [inflammatory bowel disease] are limited and lagging, compared to adult patients, so studies of non-TNF [tumor necrosis factor] biologics such vedolizumab and ustekinumab are also awaited,” he said.
Dr. Sakuraba had no financial conflicts to disclose.
This article was updated March 3, 2021.
Decline in children’s COVID-19 cases slows
The number of new COVID-19 cases in children declined for the sixth consecutive week, but the drop was the smallest yet, according to a report from the American Academy of Pediatrics and the Children’s Hospital Association.
That drop of almost 6,400 cases, or 9.0%, falls short of the declines recorded in any the previous 5 weeks, which ranged from 18,000 to 46,000 cases and 15.3% to 28.7%, based on data from the heath departments of 49 states (excluding New York), as well as the District of Columbia, New York City, Puerto Rico, and Guam.
The total number of children infected with SARS-CoV-2 is up to almost 3.17 million, which represents 13.1% of cases among all age groups. That cumulative proportion was unchanged from the previous week, which has occurred only three other times over the course of the pandemic, the AAP and CHA said in their weekly COVID-19 report.
Despite the 6-week decline in new cases, however, the cumulative rate continued to climb, rising from 4,124 cases per 100,000 children to 4,209 for the week of Feb. 19-25. The states, not surprisingly, fall on both sides of that national tally. The lowest rates can be found in Hawaii (1,040 per 100,000 children), Vermont (2,111 per 100,000), and Maine (2,394), while the highest rates were recorded in North Dakota (8,580), Tennessee (7,851), and Rhode Island (7,223), the AAP and CHA said.
The number of new child deaths, nine, stayed in single digits for a second consecutive week, although it was up from six deaths reported a week earlier. Total COVID-19–related deaths in children now number 256, which represents just 0.06% of coronavirus deaths for all ages among the 43 states (along with New York City and Guam) reporting such data.
Among those jurisdictions, Texas (40), Arizona (27), and New York City (23) have reported the most deaths in children, while nine states and the District of Columbia have reported no deaths yet, the AAP and CHA noted.
The number of new COVID-19 cases in children declined for the sixth consecutive week, but the drop was the smallest yet, according to a report from the American Academy of Pediatrics and the Children’s Hospital Association.
That drop of almost 6,400 cases, or 9.0%, falls short of the declines recorded in any the previous 5 weeks, which ranged from 18,000 to 46,000 cases and 15.3% to 28.7%, based on data from the heath departments of 49 states (excluding New York), as well as the District of Columbia, New York City, Puerto Rico, and Guam.
The total number of children infected with SARS-CoV-2 is up to almost 3.17 million, which represents 13.1% of cases among all age groups. That cumulative proportion was unchanged from the previous week, which has occurred only three other times over the course of the pandemic, the AAP and CHA said in their weekly COVID-19 report.
Despite the 6-week decline in new cases, however, the cumulative rate continued to climb, rising from 4,124 cases per 100,000 children to 4,209 for the week of Feb. 19-25. The states, not surprisingly, fall on both sides of that national tally. The lowest rates can be found in Hawaii (1,040 per 100,000 children), Vermont (2,111 per 100,000), and Maine (2,394), while the highest rates were recorded in North Dakota (8,580), Tennessee (7,851), and Rhode Island (7,223), the AAP and CHA said.
The number of new child deaths, nine, stayed in single digits for a second consecutive week, although it was up from six deaths reported a week earlier. Total COVID-19–related deaths in children now number 256, which represents just 0.06% of coronavirus deaths for all ages among the 43 states (along with New York City and Guam) reporting such data.
Among those jurisdictions, Texas (40), Arizona (27), and New York City (23) have reported the most deaths in children, while nine states and the District of Columbia have reported no deaths yet, the AAP and CHA noted.
The number of new COVID-19 cases in children declined for the sixth consecutive week, but the drop was the smallest yet, according to a report from the American Academy of Pediatrics and the Children’s Hospital Association.
That drop of almost 6,400 cases, or 9.0%, falls short of the declines recorded in any the previous 5 weeks, which ranged from 18,000 to 46,000 cases and 15.3% to 28.7%, based on data from the heath departments of 49 states (excluding New York), as well as the District of Columbia, New York City, Puerto Rico, and Guam.
The total number of children infected with SARS-CoV-2 is up to almost 3.17 million, which represents 13.1% of cases among all age groups. That cumulative proportion was unchanged from the previous week, which has occurred only three other times over the course of the pandemic, the AAP and CHA said in their weekly COVID-19 report.
Despite the 6-week decline in new cases, however, the cumulative rate continued to climb, rising from 4,124 cases per 100,000 children to 4,209 for the week of Feb. 19-25. The states, not surprisingly, fall on both sides of that national tally. The lowest rates can be found in Hawaii (1,040 per 100,000 children), Vermont (2,111 per 100,000), and Maine (2,394), while the highest rates were recorded in North Dakota (8,580), Tennessee (7,851), and Rhode Island (7,223), the AAP and CHA said.
The number of new child deaths, nine, stayed in single digits for a second consecutive week, although it was up from six deaths reported a week earlier. Total COVID-19–related deaths in children now number 256, which represents just 0.06% of coronavirus deaths for all ages among the 43 states (along with New York City and Guam) reporting such data.
Among those jurisdictions, Texas (40), Arizona (27), and New York City (23) have reported the most deaths in children, while nine states and the District of Columbia have reported no deaths yet, the AAP and CHA noted.