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Men occupy most leadership roles in medicine
Since the early 2000s, approximately half of medical students in the United States – and in many years, more than half – have been women, but according to an update provided at the virtual Pediatric Hospital Medicine.
In pediatrics, a specialty in which approximately 70% of physicians are now women, there has been progress, but still less than 30% of pediatric department chairs are female, said Vincent Chiang, MD, chief medical officer of Boston Children’s Hospital, during a presentation at the virtual meeting sponsored by the Society of Hospital Medicine, the American Academy of Pediatrics, and the Academic Pediatric Association.
Citing published data and a survey he personally conducted of the top children’s hospitals identified by the U.S. News and World Report, Dr. Chiang said a minority of division chiefs, chief medical officers, chief financial officers, and other leaders are female. At his institution, only 2 of 16 division chiefs are female.
“No matter how you slice it, women are underrepresented in leadership positions,” he noted.
The problem is certainly not confined to medicine. Dr. Chiang cited data showing that women and men have reached “near parity” in workforce participation in the United States even though the 20% earnings gap has changed little over time.
According to 2020 data from the World Economic Forum, the United States ranked 51 for the gender gap calculated on the basis of economic, political, educational, and health attainment. Even if this places the United States in the top third of the rankings, it is far behind Iceland and the Scandinavian countries that lead the list.
Efforts to reduce structural biases are part of the fix, but Dr. Chiang cautioned that fundamental changes might never occur if the plan is to wait for an approach based on meritocracy. He said that existing structural biases are “slanted away from women,” who are not necessarily granted the opportunities that are readily available to men.
“A meritocracy only works if the initial playing field was level. Otherwise, it just perpetuates the inequalities,” he said.
The problem is not a shortage of women with the skills to lead. In a study by Zenger/Folkman, a consulting company that works on leadership skill development, women performed better than men in 16 of 18 leadership categories, according to Dr. Chiang.
“There is certainly no shortage of capable women,” he noted.
Of the many issues, Dr. Chiang highlighted two. The first is the challenge of placing women on leadership pathways. This is likely to require proactive strategies, such as fast-track advancement programs that guide female candidates toward leadership roles.
The second is more nuanced. According to Dr. Chiang, women who want to assume a leadership role should think more actively about how and who is making decisions at their institution so they can position themselves appropriately. This is nuanced because “there is a certain amount of gamesmanship,” he said. The rise to leadership “has never been a pure meritocracy.”
Importantly, many of the key decisions in any institution involve money, according to Dr. Chiang. As a result, he advised those seeking leadership roles to join audit committees or otherwise take on responsibility for profit-and-loss management. Even in a nonprofit institution, “you need to make the numbers work,” he said, citing the common catchphrase: “No margin, no mission.”
However, Dr. Chiang acknowledged the many obstacles that prevent women from working their way into positions of leadership. For example, networking is important, but women are not necessarily attracted or invited to some of the social engagements, such as golf outings, where strong relationships are created.
In a survey of 100,000 people working at Fortune 500 companies, “82% of women say they feel excluded at work and much of that comes from that informal networking,” Dr. Chiang said. “Whereas 92% of men think they are not excluding women in their daily work.”
There is no single solution, but Dr. Chiang believes that concrete structural changes are needed. Female doctors remain grossly underrepresented in leadership roles even as they now represent more than half of the workforce for many specialties. Based on the need for proactive approaches outlined by Dr. Chiang, it appears unlikely that gender inequality will ever resolve itself.
Lisa S. Rotenstein, MD, who has written on fixing the gender imbalance in health care, including for the Harvard Business Review, said she agreed during an interview that structural changes are critical.
“In order to address current disparities, leaders should be thinking about how to remove both the formal and informal obstacles that prevent women and minorities from getting into the rooms where these decisions are being made,” said Dr. Rotenstein, who is an instructor in medicine at Brigham and Women’s Hospital, Harvard Medical School in Boston.
“This will need to involve sponsorship that gets women invited to the right committees or in positions with responsibility for profit-and-loss management,” she added.
Dr. Rotenstein spoke about improving “access to the pipeline” that leads to leadership roles. The ways in which women are excluded from opportunities is often subtle and difficult to penetrate without fundamental changes, she explained.
“Institutions need to understand the processes that lead to leadership roles and make the changes that allow women and minorities to participate,” she said. It is not enough to recognize the problem, according to Dr. Rotenstein.
Like Dr. Chiang, she noted that changes are needed in the methods that move underrepresented groups into leadership roles.
Dr. Chiang reported no potential conflicts of interest relevant to this study.
Since the early 2000s, approximately half of medical students in the United States – and in many years, more than half – have been women, but according to an update provided at the virtual Pediatric Hospital Medicine.
In pediatrics, a specialty in which approximately 70% of physicians are now women, there has been progress, but still less than 30% of pediatric department chairs are female, said Vincent Chiang, MD, chief medical officer of Boston Children’s Hospital, during a presentation at the virtual meeting sponsored by the Society of Hospital Medicine, the American Academy of Pediatrics, and the Academic Pediatric Association.
Citing published data and a survey he personally conducted of the top children’s hospitals identified by the U.S. News and World Report, Dr. Chiang said a minority of division chiefs, chief medical officers, chief financial officers, and other leaders are female. At his institution, only 2 of 16 division chiefs are female.
“No matter how you slice it, women are underrepresented in leadership positions,” he noted.
The problem is certainly not confined to medicine. Dr. Chiang cited data showing that women and men have reached “near parity” in workforce participation in the United States even though the 20% earnings gap has changed little over time.
According to 2020 data from the World Economic Forum, the United States ranked 51 for the gender gap calculated on the basis of economic, political, educational, and health attainment. Even if this places the United States in the top third of the rankings, it is far behind Iceland and the Scandinavian countries that lead the list.
Efforts to reduce structural biases are part of the fix, but Dr. Chiang cautioned that fundamental changes might never occur if the plan is to wait for an approach based on meritocracy. He said that existing structural biases are “slanted away from women,” who are not necessarily granted the opportunities that are readily available to men.
“A meritocracy only works if the initial playing field was level. Otherwise, it just perpetuates the inequalities,” he said.
The problem is not a shortage of women with the skills to lead. In a study by Zenger/Folkman, a consulting company that works on leadership skill development, women performed better than men in 16 of 18 leadership categories, according to Dr. Chiang.
“There is certainly no shortage of capable women,” he noted.
Of the many issues, Dr. Chiang highlighted two. The first is the challenge of placing women on leadership pathways. This is likely to require proactive strategies, such as fast-track advancement programs that guide female candidates toward leadership roles.
The second is more nuanced. According to Dr. Chiang, women who want to assume a leadership role should think more actively about how and who is making decisions at their institution so they can position themselves appropriately. This is nuanced because “there is a certain amount of gamesmanship,” he said. The rise to leadership “has never been a pure meritocracy.”
Importantly, many of the key decisions in any institution involve money, according to Dr. Chiang. As a result, he advised those seeking leadership roles to join audit committees or otherwise take on responsibility for profit-and-loss management. Even in a nonprofit institution, “you need to make the numbers work,” he said, citing the common catchphrase: “No margin, no mission.”
However, Dr. Chiang acknowledged the many obstacles that prevent women from working their way into positions of leadership. For example, networking is important, but women are not necessarily attracted or invited to some of the social engagements, such as golf outings, where strong relationships are created.
In a survey of 100,000 people working at Fortune 500 companies, “82% of women say they feel excluded at work and much of that comes from that informal networking,” Dr. Chiang said. “Whereas 92% of men think they are not excluding women in their daily work.”
There is no single solution, but Dr. Chiang believes that concrete structural changes are needed. Female doctors remain grossly underrepresented in leadership roles even as they now represent more than half of the workforce for many specialties. Based on the need for proactive approaches outlined by Dr. Chiang, it appears unlikely that gender inequality will ever resolve itself.
Lisa S. Rotenstein, MD, who has written on fixing the gender imbalance in health care, including for the Harvard Business Review, said she agreed during an interview that structural changes are critical.
“In order to address current disparities, leaders should be thinking about how to remove both the formal and informal obstacles that prevent women and minorities from getting into the rooms where these decisions are being made,” said Dr. Rotenstein, who is an instructor in medicine at Brigham and Women’s Hospital, Harvard Medical School in Boston.
“This will need to involve sponsorship that gets women invited to the right committees or in positions with responsibility for profit-and-loss management,” she added.
Dr. Rotenstein spoke about improving “access to the pipeline” that leads to leadership roles. The ways in which women are excluded from opportunities is often subtle and difficult to penetrate without fundamental changes, she explained.
“Institutions need to understand the processes that lead to leadership roles and make the changes that allow women and minorities to participate,” she said. It is not enough to recognize the problem, according to Dr. Rotenstein.
Like Dr. Chiang, she noted that changes are needed in the methods that move underrepresented groups into leadership roles.
Dr. Chiang reported no potential conflicts of interest relevant to this study.
Since the early 2000s, approximately half of medical students in the United States – and in many years, more than half – have been women, but according to an update provided at the virtual Pediatric Hospital Medicine.
In pediatrics, a specialty in which approximately 70% of physicians are now women, there has been progress, but still less than 30% of pediatric department chairs are female, said Vincent Chiang, MD, chief medical officer of Boston Children’s Hospital, during a presentation at the virtual meeting sponsored by the Society of Hospital Medicine, the American Academy of Pediatrics, and the Academic Pediatric Association.
Citing published data and a survey he personally conducted of the top children’s hospitals identified by the U.S. News and World Report, Dr. Chiang said a minority of division chiefs, chief medical officers, chief financial officers, and other leaders are female. At his institution, only 2 of 16 division chiefs are female.
“No matter how you slice it, women are underrepresented in leadership positions,” he noted.
The problem is certainly not confined to medicine. Dr. Chiang cited data showing that women and men have reached “near parity” in workforce participation in the United States even though the 20% earnings gap has changed little over time.
According to 2020 data from the World Economic Forum, the United States ranked 51 for the gender gap calculated on the basis of economic, political, educational, and health attainment. Even if this places the United States in the top third of the rankings, it is far behind Iceland and the Scandinavian countries that lead the list.
Efforts to reduce structural biases are part of the fix, but Dr. Chiang cautioned that fundamental changes might never occur if the plan is to wait for an approach based on meritocracy. He said that existing structural biases are “slanted away from women,” who are not necessarily granted the opportunities that are readily available to men.
“A meritocracy only works if the initial playing field was level. Otherwise, it just perpetuates the inequalities,” he said.
The problem is not a shortage of women with the skills to lead. In a study by Zenger/Folkman, a consulting company that works on leadership skill development, women performed better than men in 16 of 18 leadership categories, according to Dr. Chiang.
“There is certainly no shortage of capable women,” he noted.
Of the many issues, Dr. Chiang highlighted two. The first is the challenge of placing women on leadership pathways. This is likely to require proactive strategies, such as fast-track advancement programs that guide female candidates toward leadership roles.
The second is more nuanced. According to Dr. Chiang, women who want to assume a leadership role should think more actively about how and who is making decisions at their institution so they can position themselves appropriately. This is nuanced because “there is a certain amount of gamesmanship,” he said. The rise to leadership “has never been a pure meritocracy.”
Importantly, many of the key decisions in any institution involve money, according to Dr. Chiang. As a result, he advised those seeking leadership roles to join audit committees or otherwise take on responsibility for profit-and-loss management. Even in a nonprofit institution, “you need to make the numbers work,” he said, citing the common catchphrase: “No margin, no mission.”
However, Dr. Chiang acknowledged the many obstacles that prevent women from working their way into positions of leadership. For example, networking is important, but women are not necessarily attracted or invited to some of the social engagements, such as golf outings, where strong relationships are created.
In a survey of 100,000 people working at Fortune 500 companies, “82% of women say they feel excluded at work and much of that comes from that informal networking,” Dr. Chiang said. “Whereas 92% of men think they are not excluding women in their daily work.”
There is no single solution, but Dr. Chiang believes that concrete structural changes are needed. Female doctors remain grossly underrepresented in leadership roles even as they now represent more than half of the workforce for many specialties. Based on the need for proactive approaches outlined by Dr. Chiang, it appears unlikely that gender inequality will ever resolve itself.
Lisa S. Rotenstein, MD, who has written on fixing the gender imbalance in health care, including for the Harvard Business Review, said she agreed during an interview that structural changes are critical.
“In order to address current disparities, leaders should be thinking about how to remove both the formal and informal obstacles that prevent women and minorities from getting into the rooms where these decisions are being made,” said Dr. Rotenstein, who is an instructor in medicine at Brigham and Women’s Hospital, Harvard Medical School in Boston.
“This will need to involve sponsorship that gets women invited to the right committees or in positions with responsibility for profit-and-loss management,” she added.
Dr. Rotenstein spoke about improving “access to the pipeline” that leads to leadership roles. The ways in which women are excluded from opportunities is often subtle and difficult to penetrate without fundamental changes, she explained.
“Institutions need to understand the processes that lead to leadership roles and make the changes that allow women and minorities to participate,” she said. It is not enough to recognize the problem, according to Dr. Rotenstein.
Like Dr. Chiang, she noted that changes are needed in the methods that move underrepresented groups into leadership roles.
Dr. Chiang reported no potential conflicts of interest relevant to this study.
FROM PHM20
Ixekizumab deemed effective for pityriasis rubra pilaris
Teri Greiling, MD, PhD, said at the virtual annual meeting of the American Academy of Dermatology.
The interleukin-17A inhibitor induced long-term remission of pityriasis rubra pilaris (PRP) in 4 of the 11 participants in her open-label, single-arm, 24-week clinical trial of ixekizumab (Taltz) at the Food and Drug Administration–approved dosing for psoriasis. Of 11 patients, 7 experienced at least a 50% reduction in signs and symptoms of the disease. Marked quality-of-life improvements occurred as well, reported Dr. Greiling, a dermatologist at Oregon Health & Science University, Portland.
PRP is a rare papulosquamous disorder that’s challenging to diagnosis and often difficult to treat. Indeed, there is no FDA-approved treatment. The disorder is characterized by widespread follicular keratotic plaques with scale and notable islands of sparing, often with an accompanying waxy yellow palmoplantar keratoderma with fissuring. There are adult- and childhood-onset forms of PRP, as well as sporadic and familial subtypes. Some cases are associated with variants in the CARD14 gene, known to also play a role in familial psoriasis.
Patients with PRP say the disorder has a major adverse impact on their quality of life. Itching and pain are often prominent features.
The 11 study participants, drawn from throughout the United States, were adults with a mean 12-year history of symptoms. All were required to have both clinical and biopsy evidence of PRP. Five had classic adult-onset PRP, five had atypical adult-onset PRP, and one had classic juvenile-onset PRP. All had moderate or severe disease as reflected in a Physician’s Global Assessment score of 3 or 4 on the 0-4 scale. Of the 11, 10 had previously received various systemic therapies for their PRP without success.
Since there is as yet no established PRP severity grading tool, Dr. Greiling applied the principles of the Psoriasis Area and Severity Index (PASI). Participants had a mean baseline PASI score of 24.6, a Dermatology Life Quality Index (DLQI) score of 18, and itch and pain scores of 7 and 6, respectively, on a self-rated 10-point scale.
The primary outcome in the study was change in PASI score at week 24, which was 4 weeks after the final dose of ixekizumab. The mean score improved from 24.8 at week 0 to 9.7 at week 24. Five patients achieved at least a 75% decrease in PASI score, or PASI 75 response, and 2 had a PASI 90 response. The DLQI improved from 18 to 3, and both itch and pain scores dropped to a median of 1. There was no association between response to treatment and PRP clinical subtype.
The four top responders – those with a PASI 89 or better response at week 24 – remained clear or almost clear at week 36, fully 16 weeks after their last dose of ixekizumab. Patients with an intermediate week 24 response – that is, a 50%-85% reduction in PASI score – all relapsed before week 36. The patient with the worst PASI score at both baseline and 24 weeks decided to continue on ixekizumab dosed every 2 weeks independent of the study, rather than at the FDA-approved dosing every 4 weeks for psoriasis, with a resultant drop to a PASI score of 8 at week 36.
To look at mechanism of benefit, Dr. Greiling used quantitative polymerase chain reaction to examine key cytokine expression in the epidermis and dermis. Not surprisingly, IL-17A expression was markedly reduced at both sites, suggesting the importance of the Th17 axis in the pathophysiology of PRP. In contrast, there was no significant change in IL-23 expression.
No serious or unexpected adverse events occurred in the 24-week study.
“In terms of ixekizumab, compared to other treatments, I definitely think it is more effective than any conventional therapies, such as topical steroids, methotrexate, or acitretin,” she said in an interview.
Asked about other biologics, Dr. Greiling said she hasn’t found tumor necrosis factor inhibitors very helpful in her patients with PRP. A formal trial of the IL-17A inhibitor secukinumab (Cosentyx) has been done elsewhere, and although the results haven’t yet been published, her understanding is that the efficacy was similar to her ixekizumab trial.
“I’ve had some of my ixekizumab patients switch to secukinumab, for insurance reasons, though, and had it not be quite as effective, although still helpful,” she said.
Dr. Greiling is now enrolling patients with PRP in a trial of the IL-23 inhibitor guselkumab (Tremfya). It’s her early impression that this may prove to be another therapeutic option.
“I have not yet used brodalumab [Siliq], but I wonder if it would also be helpful, since it seems to have a stronger blockade, working on the IL-17 receptor A,” she said.
She cited two pressing needs that would advance PRP research: the lack of standard criteria for disease diagnosis and the absence of PRP-specific disease measurement tools. “We’re trying to remedy that,” the dermatologist said.
Her study was funded by Eli Lilly. She reported receiving research funding from that company and Janssen.
Teri Greiling, MD, PhD, said at the virtual annual meeting of the American Academy of Dermatology.
The interleukin-17A inhibitor induced long-term remission of pityriasis rubra pilaris (PRP) in 4 of the 11 participants in her open-label, single-arm, 24-week clinical trial of ixekizumab (Taltz) at the Food and Drug Administration–approved dosing for psoriasis. Of 11 patients, 7 experienced at least a 50% reduction in signs and symptoms of the disease. Marked quality-of-life improvements occurred as well, reported Dr. Greiling, a dermatologist at Oregon Health & Science University, Portland.
PRP is a rare papulosquamous disorder that’s challenging to diagnosis and often difficult to treat. Indeed, there is no FDA-approved treatment. The disorder is characterized by widespread follicular keratotic plaques with scale and notable islands of sparing, often with an accompanying waxy yellow palmoplantar keratoderma with fissuring. There are adult- and childhood-onset forms of PRP, as well as sporadic and familial subtypes. Some cases are associated with variants in the CARD14 gene, known to also play a role in familial psoriasis.
Patients with PRP say the disorder has a major adverse impact on their quality of life. Itching and pain are often prominent features.
The 11 study participants, drawn from throughout the United States, were adults with a mean 12-year history of symptoms. All were required to have both clinical and biopsy evidence of PRP. Five had classic adult-onset PRP, five had atypical adult-onset PRP, and one had classic juvenile-onset PRP. All had moderate or severe disease as reflected in a Physician’s Global Assessment score of 3 or 4 on the 0-4 scale. Of the 11, 10 had previously received various systemic therapies for their PRP without success.
Since there is as yet no established PRP severity grading tool, Dr. Greiling applied the principles of the Psoriasis Area and Severity Index (PASI). Participants had a mean baseline PASI score of 24.6, a Dermatology Life Quality Index (DLQI) score of 18, and itch and pain scores of 7 and 6, respectively, on a self-rated 10-point scale.
The primary outcome in the study was change in PASI score at week 24, which was 4 weeks after the final dose of ixekizumab. The mean score improved from 24.8 at week 0 to 9.7 at week 24. Five patients achieved at least a 75% decrease in PASI score, or PASI 75 response, and 2 had a PASI 90 response. The DLQI improved from 18 to 3, and both itch and pain scores dropped to a median of 1. There was no association between response to treatment and PRP clinical subtype.
The four top responders – those with a PASI 89 or better response at week 24 – remained clear or almost clear at week 36, fully 16 weeks after their last dose of ixekizumab. Patients with an intermediate week 24 response – that is, a 50%-85% reduction in PASI score – all relapsed before week 36. The patient with the worst PASI score at both baseline and 24 weeks decided to continue on ixekizumab dosed every 2 weeks independent of the study, rather than at the FDA-approved dosing every 4 weeks for psoriasis, with a resultant drop to a PASI score of 8 at week 36.
To look at mechanism of benefit, Dr. Greiling used quantitative polymerase chain reaction to examine key cytokine expression in the epidermis and dermis. Not surprisingly, IL-17A expression was markedly reduced at both sites, suggesting the importance of the Th17 axis in the pathophysiology of PRP. In contrast, there was no significant change in IL-23 expression.
No serious or unexpected adverse events occurred in the 24-week study.
“In terms of ixekizumab, compared to other treatments, I definitely think it is more effective than any conventional therapies, such as topical steroids, methotrexate, or acitretin,” she said in an interview.
Asked about other biologics, Dr. Greiling said she hasn’t found tumor necrosis factor inhibitors very helpful in her patients with PRP. A formal trial of the IL-17A inhibitor secukinumab (Cosentyx) has been done elsewhere, and although the results haven’t yet been published, her understanding is that the efficacy was similar to her ixekizumab trial.
“I’ve had some of my ixekizumab patients switch to secukinumab, for insurance reasons, though, and had it not be quite as effective, although still helpful,” she said.
Dr. Greiling is now enrolling patients with PRP in a trial of the IL-23 inhibitor guselkumab (Tremfya). It’s her early impression that this may prove to be another therapeutic option.
“I have not yet used brodalumab [Siliq], but I wonder if it would also be helpful, since it seems to have a stronger blockade, working on the IL-17 receptor A,” she said.
She cited two pressing needs that would advance PRP research: the lack of standard criteria for disease diagnosis and the absence of PRP-specific disease measurement tools. “We’re trying to remedy that,” the dermatologist said.
Her study was funded by Eli Lilly. She reported receiving research funding from that company and Janssen.
Teri Greiling, MD, PhD, said at the virtual annual meeting of the American Academy of Dermatology.
The interleukin-17A inhibitor induced long-term remission of pityriasis rubra pilaris (PRP) in 4 of the 11 participants in her open-label, single-arm, 24-week clinical trial of ixekizumab (Taltz) at the Food and Drug Administration–approved dosing for psoriasis. Of 11 patients, 7 experienced at least a 50% reduction in signs and symptoms of the disease. Marked quality-of-life improvements occurred as well, reported Dr. Greiling, a dermatologist at Oregon Health & Science University, Portland.
PRP is a rare papulosquamous disorder that’s challenging to diagnosis and often difficult to treat. Indeed, there is no FDA-approved treatment. The disorder is characterized by widespread follicular keratotic plaques with scale and notable islands of sparing, often with an accompanying waxy yellow palmoplantar keratoderma with fissuring. There are adult- and childhood-onset forms of PRP, as well as sporadic and familial subtypes. Some cases are associated with variants in the CARD14 gene, known to also play a role in familial psoriasis.
Patients with PRP say the disorder has a major adverse impact on their quality of life. Itching and pain are often prominent features.
The 11 study participants, drawn from throughout the United States, were adults with a mean 12-year history of symptoms. All were required to have both clinical and biopsy evidence of PRP. Five had classic adult-onset PRP, five had atypical adult-onset PRP, and one had classic juvenile-onset PRP. All had moderate or severe disease as reflected in a Physician’s Global Assessment score of 3 or 4 on the 0-4 scale. Of the 11, 10 had previously received various systemic therapies for their PRP without success.
Since there is as yet no established PRP severity grading tool, Dr. Greiling applied the principles of the Psoriasis Area and Severity Index (PASI). Participants had a mean baseline PASI score of 24.6, a Dermatology Life Quality Index (DLQI) score of 18, and itch and pain scores of 7 and 6, respectively, on a self-rated 10-point scale.
The primary outcome in the study was change in PASI score at week 24, which was 4 weeks after the final dose of ixekizumab. The mean score improved from 24.8 at week 0 to 9.7 at week 24. Five patients achieved at least a 75% decrease in PASI score, or PASI 75 response, and 2 had a PASI 90 response. The DLQI improved from 18 to 3, and both itch and pain scores dropped to a median of 1. There was no association between response to treatment and PRP clinical subtype.
The four top responders – those with a PASI 89 or better response at week 24 – remained clear or almost clear at week 36, fully 16 weeks after their last dose of ixekizumab. Patients with an intermediate week 24 response – that is, a 50%-85% reduction in PASI score – all relapsed before week 36. The patient with the worst PASI score at both baseline and 24 weeks decided to continue on ixekizumab dosed every 2 weeks independent of the study, rather than at the FDA-approved dosing every 4 weeks for psoriasis, with a resultant drop to a PASI score of 8 at week 36.
To look at mechanism of benefit, Dr. Greiling used quantitative polymerase chain reaction to examine key cytokine expression in the epidermis and dermis. Not surprisingly, IL-17A expression was markedly reduced at both sites, suggesting the importance of the Th17 axis in the pathophysiology of PRP. In contrast, there was no significant change in IL-23 expression.
No serious or unexpected adverse events occurred in the 24-week study.
“In terms of ixekizumab, compared to other treatments, I definitely think it is more effective than any conventional therapies, such as topical steroids, methotrexate, or acitretin,” she said in an interview.
Asked about other biologics, Dr. Greiling said she hasn’t found tumor necrosis factor inhibitors very helpful in her patients with PRP. A formal trial of the IL-17A inhibitor secukinumab (Cosentyx) has been done elsewhere, and although the results haven’t yet been published, her understanding is that the efficacy was similar to her ixekizumab trial.
“I’ve had some of my ixekizumab patients switch to secukinumab, for insurance reasons, though, and had it not be quite as effective, although still helpful,” she said.
Dr. Greiling is now enrolling patients with PRP in a trial of the IL-23 inhibitor guselkumab (Tremfya). It’s her early impression that this may prove to be another therapeutic option.
“I have not yet used brodalumab [Siliq], but I wonder if it would also be helpful, since it seems to have a stronger blockade, working on the IL-17 receptor A,” she said.
She cited two pressing needs that would advance PRP research: the lack of standard criteria for disease diagnosis and the absence of PRP-specific disease measurement tools. “We’re trying to remedy that,” the dermatologist said.
Her study was funded by Eli Lilly. She reported receiving research funding from that company and Janssen.
FROM AAD 2020
Intravesical BCG dosing frequency ‘critical’ in bladder cancer
The rates of recurrence were 27.1% in the reduced dosing frequency arm and 12% in the standard dosing frequency arm. These results were reported at the virtual annual congress of the European Association of Urology.
More patients in the reduced dosing frequency arm than in the standard dosing frequency arm had a shorter time to recurrence, which was the primary endpoint of the trial.
At 6 months, the rate of recurrence was 18% in the reduced frequency arm and 8% in the standard frequency arm. The gap widened further at both 12 months (24% and 11%, respectively) and 24 months (34% and 15%, respectively). The hazard ratio for time to recurrence was 0.403 in favor of the standard dosing frequency arm.
“The recommended dose and schedule of BCG consists of once-weekly installations during 6 weeks of induction, followed by 3 weeks of maintenance at 3, 6, and 12 months,” observed study investigator Marc-Oliver Grimm, MD, of Jena (Germany) University Hospital.
“BCG instillation is, however, frequently associated with adverse events, which may lead to discontinuation, and several attempts have been made to reduce symptom burden associated with BCG,” he added.
Dr. Grimm presented the recently published findings from NIMBUS (Eur Urol. 2020 May 20;S0302-2838[20]30334-1) alongside some new information from a post hoc analysis.
Trial details
NIMBUS was a randomized, unblinded study of 345 patients with high-grade NMIBC who were recruited over a prolonged period, Dr. Grimm said. The long accrual was caused by a shortage of BCG and meant that the statistical assumptions had to be revised to include fewer patients.
The trial was designed to compare induction consisting of three versus six weekly BCG instillations and maintenance consisting of two versus three weekly BCG instillations at 3, 6, and 12 months. The aim had been to show that a reduced dosing frequency of BCG – 9 rather than 15 instillations – was noninferior to the standard dosing frequency of BCG, Dr. Grimm said. However, that was not the case, and the trial had to be stopped prematurely. In October 2019, the study’s sponsor, the EAU Research Foundation, announced that the trial would end.
Despite its unexpected ending, the trial’s data now fill some knowledge gaps, as pointed out by the discussant for the trial, Peter Black, MD, of the University of British Columbia in Vancouver.
Previous studies, such as the SWOG 8507, EORTC 30962, and CUETO 98013 trials, had shown that maintenance treatment works, but the schedule matters, he said. Results have also shown that the duration of maintenance treatment is less important than the dose of BCG given.
“The NIMBUS trial now tells us that dosing frequency is critical,” Dr. Black said.
Not only did the NIMBUS trial alter the maintenance schedule, it also altered the induction course of BCG instillation.
“The dramatic difference in recurrence-free survival, especially with the large separation of K-M [Kaplan-Meier] curves early on, suggests that this change to induction has had a major impact on the outcomes,” Dr. Black observed.
Post hoc analysis
Dr. Grimm presented a post hoc analysis comparing the rates of recurrence in the NIMBUS trial with rates seen in the EORTC 30962 and CUETO 98013 trials. Dr. Black also compared NIMBUS results to results from the SWOG 8507 trial.
The analysis showed lower rates of recurrence in the standard dose frequency arm in the NIMBUS trial than in the EORTC and CUETO trials at both 12 months (11%, 25%, and 18%, respectively) and 24 months (15%, 32%, and 27%, respectively).
However, as Dr. Black pointed out, the SWOG trial had similar recurrence rates as the NIMBUS trial at 12 months (9% and 11%, respectively) and 24 months (19% and 15%, respectively).
Dr. Grimm suggested that the lower rates of recurrence in the standard dosing arm of NIMBUS versus the other trials might have been because 91% of patients in the NIMBUS trial having undergone repeat transurethral resection for bladder tumor before BCG instillation.
Dr. Black said while this might have had an effect, it was probably not the only answer. While it’s true that the other trials had not considered repeat transurethral resection for bladder tumor, there were other confounding factors that might have been important, from patient selection bias to the use of advanced cystoscopy technologies, he said.
“If we really want to discern differences between surgery and intravesical therapy, we need to focus on CIS [carcinoma in situ] patients. Although this has major implications on feasibility since the patient pool is smaller,” Dr. Black said.
“One final point I’d like to make is that we really need to use these trials to understand the biology of non–muscle invasive bladder cancer,” he said. ”We know that BCG induces a cellular response, and we can measure this, as well as cytokine response. We know that the response builds to a plateau over four to six doses of induction and over two to three doses of maintenance therapy. This is perhaps more rapid in patients with pre-existing BCG immune reactivity. But there is biological rationale for the current six-plus-three protocol, and I think the reduced dose frequency in the NIMBUS trial probably failed to achieve the same immune activation as the established protocol.”
“If we were faced with a BCG shortage, it is better to reduce dose or duration of therapy but not the frequency of dosing,” Dr. Black added.
The NIMBUS trial was sponsored by the EAU Research Foundation. Dr. Grimm disclosed ties to Novartis, Bristol-Myers Squibb, Pfizer, AstraZeneca, and many other pharmaceutical companies. Dr. Black had no conflicts of interests relevant to his comments.
SOURCE: Grimm M-O. EAU20. https://urosource.uroweb.org/resource-centre/EAU20V/212877/Abstract/
The rates of recurrence were 27.1% in the reduced dosing frequency arm and 12% in the standard dosing frequency arm. These results were reported at the virtual annual congress of the European Association of Urology.
More patients in the reduced dosing frequency arm than in the standard dosing frequency arm had a shorter time to recurrence, which was the primary endpoint of the trial.
At 6 months, the rate of recurrence was 18% in the reduced frequency arm and 8% in the standard frequency arm. The gap widened further at both 12 months (24% and 11%, respectively) and 24 months (34% and 15%, respectively). The hazard ratio for time to recurrence was 0.403 in favor of the standard dosing frequency arm.
“The recommended dose and schedule of BCG consists of once-weekly installations during 6 weeks of induction, followed by 3 weeks of maintenance at 3, 6, and 12 months,” observed study investigator Marc-Oliver Grimm, MD, of Jena (Germany) University Hospital.
“BCG instillation is, however, frequently associated with adverse events, which may lead to discontinuation, and several attempts have been made to reduce symptom burden associated with BCG,” he added.
Dr. Grimm presented the recently published findings from NIMBUS (Eur Urol. 2020 May 20;S0302-2838[20]30334-1) alongside some new information from a post hoc analysis.
Trial details
NIMBUS was a randomized, unblinded study of 345 patients with high-grade NMIBC who were recruited over a prolonged period, Dr. Grimm said. The long accrual was caused by a shortage of BCG and meant that the statistical assumptions had to be revised to include fewer patients.
The trial was designed to compare induction consisting of three versus six weekly BCG instillations and maintenance consisting of two versus three weekly BCG instillations at 3, 6, and 12 months. The aim had been to show that a reduced dosing frequency of BCG – 9 rather than 15 instillations – was noninferior to the standard dosing frequency of BCG, Dr. Grimm said. However, that was not the case, and the trial had to be stopped prematurely. In October 2019, the study’s sponsor, the EAU Research Foundation, announced that the trial would end.
Despite its unexpected ending, the trial’s data now fill some knowledge gaps, as pointed out by the discussant for the trial, Peter Black, MD, of the University of British Columbia in Vancouver.
Previous studies, such as the SWOG 8507, EORTC 30962, and CUETO 98013 trials, had shown that maintenance treatment works, but the schedule matters, he said. Results have also shown that the duration of maintenance treatment is less important than the dose of BCG given.
“The NIMBUS trial now tells us that dosing frequency is critical,” Dr. Black said.
Not only did the NIMBUS trial alter the maintenance schedule, it also altered the induction course of BCG instillation.
“The dramatic difference in recurrence-free survival, especially with the large separation of K-M [Kaplan-Meier] curves early on, suggests that this change to induction has had a major impact on the outcomes,” Dr. Black observed.
Post hoc analysis
Dr. Grimm presented a post hoc analysis comparing the rates of recurrence in the NIMBUS trial with rates seen in the EORTC 30962 and CUETO 98013 trials. Dr. Black also compared NIMBUS results to results from the SWOG 8507 trial.
The analysis showed lower rates of recurrence in the standard dose frequency arm in the NIMBUS trial than in the EORTC and CUETO trials at both 12 months (11%, 25%, and 18%, respectively) and 24 months (15%, 32%, and 27%, respectively).
However, as Dr. Black pointed out, the SWOG trial had similar recurrence rates as the NIMBUS trial at 12 months (9% and 11%, respectively) and 24 months (19% and 15%, respectively).
Dr. Grimm suggested that the lower rates of recurrence in the standard dosing arm of NIMBUS versus the other trials might have been because 91% of patients in the NIMBUS trial having undergone repeat transurethral resection for bladder tumor before BCG instillation.
Dr. Black said while this might have had an effect, it was probably not the only answer. While it’s true that the other trials had not considered repeat transurethral resection for bladder tumor, there were other confounding factors that might have been important, from patient selection bias to the use of advanced cystoscopy technologies, he said.
“If we really want to discern differences between surgery and intravesical therapy, we need to focus on CIS [carcinoma in situ] patients. Although this has major implications on feasibility since the patient pool is smaller,” Dr. Black said.
“One final point I’d like to make is that we really need to use these trials to understand the biology of non–muscle invasive bladder cancer,” he said. ”We know that BCG induces a cellular response, and we can measure this, as well as cytokine response. We know that the response builds to a plateau over four to six doses of induction and over two to three doses of maintenance therapy. This is perhaps more rapid in patients with pre-existing BCG immune reactivity. But there is biological rationale for the current six-plus-three protocol, and I think the reduced dose frequency in the NIMBUS trial probably failed to achieve the same immune activation as the established protocol.”
“If we were faced with a BCG shortage, it is better to reduce dose or duration of therapy but not the frequency of dosing,” Dr. Black added.
The NIMBUS trial was sponsored by the EAU Research Foundation. Dr. Grimm disclosed ties to Novartis, Bristol-Myers Squibb, Pfizer, AstraZeneca, and many other pharmaceutical companies. Dr. Black had no conflicts of interests relevant to his comments.
SOURCE: Grimm M-O. EAU20. https://urosource.uroweb.org/resource-centre/EAU20V/212877/Abstract/
The rates of recurrence were 27.1% in the reduced dosing frequency arm and 12% in the standard dosing frequency arm. These results were reported at the virtual annual congress of the European Association of Urology.
More patients in the reduced dosing frequency arm than in the standard dosing frequency arm had a shorter time to recurrence, which was the primary endpoint of the trial.
At 6 months, the rate of recurrence was 18% in the reduced frequency arm and 8% in the standard frequency arm. The gap widened further at both 12 months (24% and 11%, respectively) and 24 months (34% and 15%, respectively). The hazard ratio for time to recurrence was 0.403 in favor of the standard dosing frequency arm.
“The recommended dose and schedule of BCG consists of once-weekly installations during 6 weeks of induction, followed by 3 weeks of maintenance at 3, 6, and 12 months,” observed study investigator Marc-Oliver Grimm, MD, of Jena (Germany) University Hospital.
“BCG instillation is, however, frequently associated with adverse events, which may lead to discontinuation, and several attempts have been made to reduce symptom burden associated with BCG,” he added.
Dr. Grimm presented the recently published findings from NIMBUS (Eur Urol. 2020 May 20;S0302-2838[20]30334-1) alongside some new information from a post hoc analysis.
Trial details
NIMBUS was a randomized, unblinded study of 345 patients with high-grade NMIBC who were recruited over a prolonged period, Dr. Grimm said. The long accrual was caused by a shortage of BCG and meant that the statistical assumptions had to be revised to include fewer patients.
The trial was designed to compare induction consisting of three versus six weekly BCG instillations and maintenance consisting of two versus three weekly BCG instillations at 3, 6, and 12 months. The aim had been to show that a reduced dosing frequency of BCG – 9 rather than 15 instillations – was noninferior to the standard dosing frequency of BCG, Dr. Grimm said. However, that was not the case, and the trial had to be stopped prematurely. In October 2019, the study’s sponsor, the EAU Research Foundation, announced that the trial would end.
Despite its unexpected ending, the trial’s data now fill some knowledge gaps, as pointed out by the discussant for the trial, Peter Black, MD, of the University of British Columbia in Vancouver.
Previous studies, such as the SWOG 8507, EORTC 30962, and CUETO 98013 trials, had shown that maintenance treatment works, but the schedule matters, he said. Results have also shown that the duration of maintenance treatment is less important than the dose of BCG given.
“The NIMBUS trial now tells us that dosing frequency is critical,” Dr. Black said.
Not only did the NIMBUS trial alter the maintenance schedule, it also altered the induction course of BCG instillation.
“The dramatic difference in recurrence-free survival, especially with the large separation of K-M [Kaplan-Meier] curves early on, suggests that this change to induction has had a major impact on the outcomes,” Dr. Black observed.
Post hoc analysis
Dr. Grimm presented a post hoc analysis comparing the rates of recurrence in the NIMBUS trial with rates seen in the EORTC 30962 and CUETO 98013 trials. Dr. Black also compared NIMBUS results to results from the SWOG 8507 trial.
The analysis showed lower rates of recurrence in the standard dose frequency arm in the NIMBUS trial than in the EORTC and CUETO trials at both 12 months (11%, 25%, and 18%, respectively) and 24 months (15%, 32%, and 27%, respectively).
However, as Dr. Black pointed out, the SWOG trial had similar recurrence rates as the NIMBUS trial at 12 months (9% and 11%, respectively) and 24 months (19% and 15%, respectively).
Dr. Grimm suggested that the lower rates of recurrence in the standard dosing arm of NIMBUS versus the other trials might have been because 91% of patients in the NIMBUS trial having undergone repeat transurethral resection for bladder tumor before BCG instillation.
Dr. Black said while this might have had an effect, it was probably not the only answer. While it’s true that the other trials had not considered repeat transurethral resection for bladder tumor, there were other confounding factors that might have been important, from patient selection bias to the use of advanced cystoscopy technologies, he said.
“If we really want to discern differences between surgery and intravesical therapy, we need to focus on CIS [carcinoma in situ] patients. Although this has major implications on feasibility since the patient pool is smaller,” Dr. Black said.
“One final point I’d like to make is that we really need to use these trials to understand the biology of non–muscle invasive bladder cancer,” he said. ”We know that BCG induces a cellular response, and we can measure this, as well as cytokine response. We know that the response builds to a plateau over four to six doses of induction and over two to three doses of maintenance therapy. This is perhaps more rapid in patients with pre-existing BCG immune reactivity. But there is biological rationale for the current six-plus-three protocol, and I think the reduced dose frequency in the NIMBUS trial probably failed to achieve the same immune activation as the established protocol.”
“If we were faced with a BCG shortage, it is better to reduce dose or duration of therapy but not the frequency of dosing,” Dr. Black added.
The NIMBUS trial was sponsored by the EAU Research Foundation. Dr. Grimm disclosed ties to Novartis, Bristol-Myers Squibb, Pfizer, AstraZeneca, and many other pharmaceutical companies. Dr. Black had no conflicts of interests relevant to his comments.
SOURCE: Grimm M-O. EAU20. https://urosource.uroweb.org/resource-centre/EAU20V/212877/Abstract/
FROM EAU20
Learn to anticipate, resolve difficult interactions with patients
Every physician encounters difficult or challenging patients during their career, but learning how to anticipate and handle these interactions is not something taught in medical school or residency, according to Donald W. Black, MD, MS.
Difficult or challenging encounters with patients are not only unavoidable, they should be expected, Dr. Black said in a virtual meeting presented by Current Psychiatry and the American Academy of Clinical Psychiatrists.
“Every doctor I know has had challenging interactions,” he said. About 15% of encounters were deemed “difficult” in a prospective study of patients by Jeffrey L. Jackson, MD, MPH, and Kurt Kroenke, MD. A depressive or anxiety disorder was present in 29% of patients, with 11% experiencing two or more disorders. Major depression was present in 8.4%, other depressive disorders in 17.4%, panic disorder in 1.4%, and other anxiety disorders in 14.2% of patients. Dr. Jackson and Dr. Kroenke found that difficult patients demonstrated disrespect and anger, made threats, and locked themselves in rooms (Arch Intern Med. 1999 May 24;159[10]:1069-75). “Rest assured, you are not the only psychiatrist to face this type of issue,” Dr. Black said at the meeting, presented by Global Academy for Medical Education.
Common scenarios can include patients who want certain tests performed after researching symptoms online, threats of legal or social media action after feeling like they are not being listened to, a demand for a second opinion after not agreeing with a physician’s diagnosis, mistrust of doctors after presenting with symptoms and not being diagnosed, patients who focus on negative outcomes, and those who do not comply with treatment. These patients can often appear angry, defensive, frightened or resistant, or manipulative; may provide vague or exaggerated symptoms; or may inappropriately rely on hospital or clinic staff for emotional and physical support.
To complicate matters, the patients’ condition also might contribute to difficult interactions, such as in patients who have conditions like chronic pain or fibromyalgia.
“These often contribute because patients never feel that their problems are being appropriately addressed,” said Dr. Black, professor of psychiatry at the University of Iowa in Iowa City. Patients with psychiatric disorders can also present unique challenges that may result in difficult encounters. Patients with anxiety might not be able to be reassured by their doctor, for example, or patients with eating disorders might refuse treatment recommendations, he said.
Difficult encounters can lead to physicians feeling angry, upset, stressed, disrespected, abused, or fearful. But “it’s not just about the patient,” Dr. Black said. Physicians can become angry or defensive because of burnout, stress, or frustration, which can lead to them snapping at patients. Physicians are also overworked, sleep-deprived, and busier than they’d like to be, he added. Personal problems can contribute, and a physician’s belief system can cause a bad interaction with a patient. If physicians “label” one of their patients, that might end up becoming a “self-fulfilling prophecy” for that patient, Dr. Black said. Poor communication, such as not conveying bad news appropriately or with empathy, seeing a patient but never making eye contact, and using medical jargon that could be confusing to the patient, also can contribute to a challenging encounter, he added.
Situational issues also might create a bad experience for the patient. For example, a patient might find it hard to make an appointment, or the clinic might be busy or have a lack of privacy or encounter administrative issues. For patients who do not speak English as their native language, not having access to an interpreter can lead to frustration on the part of both the physician and the patient. “Bad interactions are not good for patient care,” Dr. Black said.
The key to resolving these issues is to focus on the goal, Dr. Black said. “We all want the same thing. We want to help the patient get better; we want to keep patients healthy; we want to keep them happy; we want to be fulfilled; [and] we want to manage our time and make a living – and meet our professional expectations.”
Begin by recognizing the difficult situation and assessing how the patient, the environment, or you might be contributing to the problem. “You have to step back and say what’s going on with this, and what are the factors that are combining to create this situation,” Dr. Black said. It is important to be calm and professional and not argue or talk over the patient. The goal is to work with the patient to find a solution.
One technique is to verbalize the problem without blaming the patient, the physician, or the environment (“We both have very different views about how your symptoms should be investigated, and that’s causing some difficulty between us. Do you agree?”).
There also might be alternative explanations for a patient’s behavior. For example, anger could be misdirected at a physician because of anxiety surrounding an unrelated event. In this case, it is important to listen to the patient and empathize, which will help the patient feel supported and build a rapport that can aid in resolving the problem encounter, Dr. Black said. Finding common ground when patients and physicians have different ideas on treatment or diagnosis is another way to help resolve a difficult encounter.
However, setting boundaries also is important, he noted. If, after remediation or if patients demonstrate signs of threatening or abusive behavior, initiate sexual advances, refuse to follow a treatment plan, fail to pay their bills, or are potentially putting themselves in harm’s way through noncompliance, a physician might consider terminating the relationship. Terminating the patient relationship should be done after attempting to work with the patient through a case manager and team members, and clearly advising a patient about behavior that could lead to termination of the patient-provider relationship.
Global Academy and this news organization are owned by the same parent company. Dr. Black reported that he is a consultant for Otsuka and receives royalties from American Psychiatric Publishing, Oxford University Press, and UpToDate. In addition, he receives funding from Nellie Ball Trust, the National Institute on Drug Abuse, the National Institute on Aging, and the National Center for Responsible Gaming.
Every physician encounters difficult or challenging patients during their career, but learning how to anticipate and handle these interactions is not something taught in medical school or residency, according to Donald W. Black, MD, MS.
Difficult or challenging encounters with patients are not only unavoidable, they should be expected, Dr. Black said in a virtual meeting presented by Current Psychiatry and the American Academy of Clinical Psychiatrists.
“Every doctor I know has had challenging interactions,” he said. About 15% of encounters were deemed “difficult” in a prospective study of patients by Jeffrey L. Jackson, MD, MPH, and Kurt Kroenke, MD. A depressive or anxiety disorder was present in 29% of patients, with 11% experiencing two or more disorders. Major depression was present in 8.4%, other depressive disorders in 17.4%, panic disorder in 1.4%, and other anxiety disorders in 14.2% of patients. Dr. Jackson and Dr. Kroenke found that difficult patients demonstrated disrespect and anger, made threats, and locked themselves in rooms (Arch Intern Med. 1999 May 24;159[10]:1069-75). “Rest assured, you are not the only psychiatrist to face this type of issue,” Dr. Black said at the meeting, presented by Global Academy for Medical Education.
Common scenarios can include patients who want certain tests performed after researching symptoms online, threats of legal or social media action after feeling like they are not being listened to, a demand for a second opinion after not agreeing with a physician’s diagnosis, mistrust of doctors after presenting with symptoms and not being diagnosed, patients who focus on negative outcomes, and those who do not comply with treatment. These patients can often appear angry, defensive, frightened or resistant, or manipulative; may provide vague or exaggerated symptoms; or may inappropriately rely on hospital or clinic staff for emotional and physical support.
To complicate matters, the patients’ condition also might contribute to difficult interactions, such as in patients who have conditions like chronic pain or fibromyalgia.
“These often contribute because patients never feel that their problems are being appropriately addressed,” said Dr. Black, professor of psychiatry at the University of Iowa in Iowa City. Patients with psychiatric disorders can also present unique challenges that may result in difficult encounters. Patients with anxiety might not be able to be reassured by their doctor, for example, or patients with eating disorders might refuse treatment recommendations, he said.
Difficult encounters can lead to physicians feeling angry, upset, stressed, disrespected, abused, or fearful. But “it’s not just about the patient,” Dr. Black said. Physicians can become angry or defensive because of burnout, stress, or frustration, which can lead to them snapping at patients. Physicians are also overworked, sleep-deprived, and busier than they’d like to be, he added. Personal problems can contribute, and a physician’s belief system can cause a bad interaction with a patient. If physicians “label” one of their patients, that might end up becoming a “self-fulfilling prophecy” for that patient, Dr. Black said. Poor communication, such as not conveying bad news appropriately or with empathy, seeing a patient but never making eye contact, and using medical jargon that could be confusing to the patient, also can contribute to a challenging encounter, he added.
Situational issues also might create a bad experience for the patient. For example, a patient might find it hard to make an appointment, or the clinic might be busy or have a lack of privacy or encounter administrative issues. For patients who do not speak English as their native language, not having access to an interpreter can lead to frustration on the part of both the physician and the patient. “Bad interactions are not good for patient care,” Dr. Black said.
The key to resolving these issues is to focus on the goal, Dr. Black said. “We all want the same thing. We want to help the patient get better; we want to keep patients healthy; we want to keep them happy; we want to be fulfilled; [and] we want to manage our time and make a living – and meet our professional expectations.”
Begin by recognizing the difficult situation and assessing how the patient, the environment, or you might be contributing to the problem. “You have to step back and say what’s going on with this, and what are the factors that are combining to create this situation,” Dr. Black said. It is important to be calm and professional and not argue or talk over the patient. The goal is to work with the patient to find a solution.
One technique is to verbalize the problem without blaming the patient, the physician, or the environment (“We both have very different views about how your symptoms should be investigated, and that’s causing some difficulty between us. Do you agree?”).
There also might be alternative explanations for a patient’s behavior. For example, anger could be misdirected at a physician because of anxiety surrounding an unrelated event. In this case, it is important to listen to the patient and empathize, which will help the patient feel supported and build a rapport that can aid in resolving the problem encounter, Dr. Black said. Finding common ground when patients and physicians have different ideas on treatment or diagnosis is another way to help resolve a difficult encounter.
However, setting boundaries also is important, he noted. If, after remediation or if patients demonstrate signs of threatening or abusive behavior, initiate sexual advances, refuse to follow a treatment plan, fail to pay their bills, or are potentially putting themselves in harm’s way through noncompliance, a physician might consider terminating the relationship. Terminating the patient relationship should be done after attempting to work with the patient through a case manager and team members, and clearly advising a patient about behavior that could lead to termination of the patient-provider relationship.
Global Academy and this news organization are owned by the same parent company. Dr. Black reported that he is a consultant for Otsuka and receives royalties from American Psychiatric Publishing, Oxford University Press, and UpToDate. In addition, he receives funding from Nellie Ball Trust, the National Institute on Drug Abuse, the National Institute on Aging, and the National Center for Responsible Gaming.
Every physician encounters difficult or challenging patients during their career, but learning how to anticipate and handle these interactions is not something taught in medical school or residency, according to Donald W. Black, MD, MS.
Difficult or challenging encounters with patients are not only unavoidable, they should be expected, Dr. Black said in a virtual meeting presented by Current Psychiatry and the American Academy of Clinical Psychiatrists.
“Every doctor I know has had challenging interactions,” he said. About 15% of encounters were deemed “difficult” in a prospective study of patients by Jeffrey L. Jackson, MD, MPH, and Kurt Kroenke, MD. A depressive or anxiety disorder was present in 29% of patients, with 11% experiencing two or more disorders. Major depression was present in 8.4%, other depressive disorders in 17.4%, panic disorder in 1.4%, and other anxiety disorders in 14.2% of patients. Dr. Jackson and Dr. Kroenke found that difficult patients demonstrated disrespect and anger, made threats, and locked themselves in rooms (Arch Intern Med. 1999 May 24;159[10]:1069-75). “Rest assured, you are not the only psychiatrist to face this type of issue,” Dr. Black said at the meeting, presented by Global Academy for Medical Education.
Common scenarios can include patients who want certain tests performed after researching symptoms online, threats of legal or social media action after feeling like they are not being listened to, a demand for a second opinion after not agreeing with a physician’s diagnosis, mistrust of doctors after presenting with symptoms and not being diagnosed, patients who focus on negative outcomes, and those who do not comply with treatment. These patients can often appear angry, defensive, frightened or resistant, or manipulative; may provide vague or exaggerated symptoms; or may inappropriately rely on hospital or clinic staff for emotional and physical support.
To complicate matters, the patients’ condition also might contribute to difficult interactions, such as in patients who have conditions like chronic pain or fibromyalgia.
“These often contribute because patients never feel that their problems are being appropriately addressed,” said Dr. Black, professor of psychiatry at the University of Iowa in Iowa City. Patients with psychiatric disorders can also present unique challenges that may result in difficult encounters. Patients with anxiety might not be able to be reassured by their doctor, for example, or patients with eating disorders might refuse treatment recommendations, he said.
Difficult encounters can lead to physicians feeling angry, upset, stressed, disrespected, abused, or fearful. But “it’s not just about the patient,” Dr. Black said. Physicians can become angry or defensive because of burnout, stress, or frustration, which can lead to them snapping at patients. Physicians are also overworked, sleep-deprived, and busier than they’d like to be, he added. Personal problems can contribute, and a physician’s belief system can cause a bad interaction with a patient. If physicians “label” one of their patients, that might end up becoming a “self-fulfilling prophecy” for that patient, Dr. Black said. Poor communication, such as not conveying bad news appropriately or with empathy, seeing a patient but never making eye contact, and using medical jargon that could be confusing to the patient, also can contribute to a challenging encounter, he added.
Situational issues also might create a bad experience for the patient. For example, a patient might find it hard to make an appointment, or the clinic might be busy or have a lack of privacy or encounter administrative issues. For patients who do not speak English as their native language, not having access to an interpreter can lead to frustration on the part of both the physician and the patient. “Bad interactions are not good for patient care,” Dr. Black said.
The key to resolving these issues is to focus on the goal, Dr. Black said. “We all want the same thing. We want to help the patient get better; we want to keep patients healthy; we want to keep them happy; we want to be fulfilled; [and] we want to manage our time and make a living – and meet our professional expectations.”
Begin by recognizing the difficult situation and assessing how the patient, the environment, or you might be contributing to the problem. “You have to step back and say what’s going on with this, and what are the factors that are combining to create this situation,” Dr. Black said. It is important to be calm and professional and not argue or talk over the patient. The goal is to work with the patient to find a solution.
One technique is to verbalize the problem without blaming the patient, the physician, or the environment (“We both have very different views about how your symptoms should be investigated, and that’s causing some difficulty between us. Do you agree?”).
There also might be alternative explanations for a patient’s behavior. For example, anger could be misdirected at a physician because of anxiety surrounding an unrelated event. In this case, it is important to listen to the patient and empathize, which will help the patient feel supported and build a rapport that can aid in resolving the problem encounter, Dr. Black said. Finding common ground when patients and physicians have different ideas on treatment or diagnosis is another way to help resolve a difficult encounter.
However, setting boundaries also is important, he noted. If, after remediation or if patients demonstrate signs of threatening or abusive behavior, initiate sexual advances, refuse to follow a treatment plan, fail to pay their bills, or are potentially putting themselves in harm’s way through noncompliance, a physician might consider terminating the relationship. Terminating the patient relationship should be done after attempting to work with the patient through a case manager and team members, and clearly advising a patient about behavior that could lead to termination of the patient-provider relationship.
Global Academy and this news organization are owned by the same parent company. Dr. Black reported that he is a consultant for Otsuka and receives royalties from American Psychiatric Publishing, Oxford University Press, and UpToDate. In addition, he receives funding from Nellie Ball Trust, the National Institute on Drug Abuse, the National Institute on Aging, and the National Center for Responsible Gaming.
FROM CP/AACP PSYCHIATRY UPDATE
Novel drug may lower agitation, aggression in multiple psychiatric disorders
The novel lysine-specific demethylase 1 inhibitor vafidemstat (ORY-2001, Oryzon Genomics) is effective for treating agitation and aggression across a number of psychiatric disorders, new research suggests.
The REIMAGINE trial included 30 patients with autism spectrum disorder (ASD), ADHD, or borderline personality disorder (BPD). Results showed significant improvements after 8 weeks in general functioning and agitation-aggression scores for all three disorders.
The study “supports vafidemstat as an emerging therapeutic option to treat aggression-agitation, as well as the nonaggression features of psychiatric diseases with high unmet medical need,” lead researcher Roger Bullock, MD, Oryzon Genomics, Corneliá De Llobregat, Spain, told Medscape Medical News.
Bullock added.
However, another expert urged prudence when interpreting the findings.
“The study results must be viewed with caution, given the inherent limitations of an open-label trial, small sample size, and weak rationale for the sample selection,” said Nathan Kolla, MD, PhD, a psychiatrist at the University of Toronto, Canada, who was not involved with the research.
The findings were presented at the European Psychiatric Association (EPA) 2020 Congress, which was held online this year because of the COVID-19 pandemic.
Little evidence available
“Epigenetic mechanisms have been proposed in many psychiatric conditions, but so far, little clinical evidence is available,” Bullock said during his presentation.
In preclinical models, vafidemstat has been associated with a reduction in aggressive behavior “and the normal response to stress of immediate early genes in the prefrontal cortex” via the modification of gene transcription, noted Bullock.
“This new approach makes it a good candidate to look at aggression in multiple psychiatric and CNS conditions,” he added.
REIMAGINE was a phase 2a open-label trial that included 30 patients (53% women; mean age, 33.5 years; 87% White) with psychiatric disorders who had significant or persistent agitation or aggression that was disruptive of the patients› daily life.
Among the participants, 12 had BPD, 11 had ADHD, and seven had ASD. All were treated with vafidemstat 1.2 mg for 8 weeks.
In all, 23 patients completed all 8 weeks of treatment, including nine patients with BPD, eight with ADHD, and six with ASD.
Results showed that the study drug was well tolerated, with no serious adverse events reported and no patients withdrawing because of safety-related events.
The most common adverse events were headache (20%) and insomnia (10%), which resolved without intervention or treatment modification.
Significantly improved scores
Across the whole cohort, the drug was associated with significant reductions in scores over baseline on the Clinical Global Impression–Severity (CGI-S) and CGI-Improvement (CGI-I) scales. There were also significant improvements for Neuropsychiatric Inventory (NPI) total scores and agitation-aggression scores (P < .001 for comparisons).
Similar results were observed with respect to individual diagnoses, albeit at varying degrees of significance for each scale.
Patients with BPD experienced significant reductions in scores on the Borderline Personality Disorder Checklist (BPDCL) (P < .01). Patients with ADHD experienced reductions on the ADHD Rating Scale (P < .05).
Patients with BPD also experienced reductions in suicidal ideation, as measured with the Columbia Suicide Severity Rating Scale (P < .01). That is “the only cohort where this trait is relevant,” the researchers note.
In addition, significant correlations were shown between NPI total scores and scores on the BPDCL after treatment with vafidemstat (P = .015), as well as between NPI agitation-aggression scores and both CGI-I (P = .008) and CGI-S scores (P = .0001).
“This convergence of signals in scales of different nature and scope support the pharmacological role of vafidemstat in controlling aggression-agitation in different psychiatric conditions,” the investigators note.
Bullock added that further randomized placebo-controlled clinical trials “to confirm vafidemstat’s potential to treat aggression-agitation in psychiatric disorders are now planned.”
First up will be PORTICO, which is planned to start over the coming months in Spain and will include patients with BPD.
Several limitations
Commenting on the study for Medscape Medical News, Kolla, who is also a researcher at the Center for Addiction and Mental Health, noted that REIMAGINE was originally designed to test vafidemstat for the treatment of agitation and aggression in patients with Alzheimer’s disease (AD).
“It seems peculiar that the study investigators would choose to examine three additional psychiatric disorders that bear little resemblance to AD in terms of phenomenology. Additionally, the etiological underpinnings of the three disorders likely differ markedly from AD,” said Kolla, who was not involved with the research.
In addition, the “very small” sample size in each group makes it difficult to interpret the investigators’ conclusions, he noted.
There are also “many more sophisticated scales” to assess agitation and aggression than what were used in the study, he added.
Kolla also questioned the notion that a drug such as vafidemstat satisfies an unmet clinical need for the treatment of aggression and agitation.
Trials that “purport to reduce aggression in these populations often provide some level of global improvement in functioning that may appear as if they directly treat agitation or aggression,” he said. “However, no drug has ever been developed that directly reduces aggression and agitation.”
That means that, for now, there is insufficient evidence to “conclude that vafidemstat overcomes the unmet medical need of treating aggression/agitation,” he said.
For Kolla, the concept of a psychiatric drug that works by effecting epigenetic changes to the genome is also questionable, although such mechanisms may “play a role in the salubrious effects of certain mood stabilizers or antipsychotics for which better-defined mechanisms of action have been established.”
The study was funded by Oryzon Genomics. Bullock and the other investigators are employees of Oryzon Genomics.
This article first appeared on Medscape.com.
The novel lysine-specific demethylase 1 inhibitor vafidemstat (ORY-2001, Oryzon Genomics) is effective for treating agitation and aggression across a number of psychiatric disorders, new research suggests.
The REIMAGINE trial included 30 patients with autism spectrum disorder (ASD), ADHD, or borderline personality disorder (BPD). Results showed significant improvements after 8 weeks in general functioning and agitation-aggression scores for all three disorders.
The study “supports vafidemstat as an emerging therapeutic option to treat aggression-agitation, as well as the nonaggression features of psychiatric diseases with high unmet medical need,” lead researcher Roger Bullock, MD, Oryzon Genomics, Corneliá De Llobregat, Spain, told Medscape Medical News.
Bullock added.
However, another expert urged prudence when interpreting the findings.
“The study results must be viewed with caution, given the inherent limitations of an open-label trial, small sample size, and weak rationale for the sample selection,” said Nathan Kolla, MD, PhD, a psychiatrist at the University of Toronto, Canada, who was not involved with the research.
The findings were presented at the European Psychiatric Association (EPA) 2020 Congress, which was held online this year because of the COVID-19 pandemic.
Little evidence available
“Epigenetic mechanisms have been proposed in many psychiatric conditions, but so far, little clinical evidence is available,” Bullock said during his presentation.
In preclinical models, vafidemstat has been associated with a reduction in aggressive behavior “and the normal response to stress of immediate early genes in the prefrontal cortex” via the modification of gene transcription, noted Bullock.
“This new approach makes it a good candidate to look at aggression in multiple psychiatric and CNS conditions,” he added.
REIMAGINE was a phase 2a open-label trial that included 30 patients (53% women; mean age, 33.5 years; 87% White) with psychiatric disorders who had significant or persistent agitation or aggression that was disruptive of the patients› daily life.
Among the participants, 12 had BPD, 11 had ADHD, and seven had ASD. All were treated with vafidemstat 1.2 mg for 8 weeks.
In all, 23 patients completed all 8 weeks of treatment, including nine patients with BPD, eight with ADHD, and six with ASD.
Results showed that the study drug was well tolerated, with no serious adverse events reported and no patients withdrawing because of safety-related events.
The most common adverse events were headache (20%) and insomnia (10%), which resolved without intervention or treatment modification.
Significantly improved scores
Across the whole cohort, the drug was associated with significant reductions in scores over baseline on the Clinical Global Impression–Severity (CGI-S) and CGI-Improvement (CGI-I) scales. There were also significant improvements for Neuropsychiatric Inventory (NPI) total scores and agitation-aggression scores (P < .001 for comparisons).
Similar results were observed with respect to individual diagnoses, albeit at varying degrees of significance for each scale.
Patients with BPD experienced significant reductions in scores on the Borderline Personality Disorder Checklist (BPDCL) (P < .01). Patients with ADHD experienced reductions on the ADHD Rating Scale (P < .05).
Patients with BPD also experienced reductions in suicidal ideation, as measured with the Columbia Suicide Severity Rating Scale (P < .01). That is “the only cohort where this trait is relevant,” the researchers note.
In addition, significant correlations were shown between NPI total scores and scores on the BPDCL after treatment with vafidemstat (P = .015), as well as between NPI agitation-aggression scores and both CGI-I (P = .008) and CGI-S scores (P = .0001).
“This convergence of signals in scales of different nature and scope support the pharmacological role of vafidemstat in controlling aggression-agitation in different psychiatric conditions,” the investigators note.
Bullock added that further randomized placebo-controlled clinical trials “to confirm vafidemstat’s potential to treat aggression-agitation in psychiatric disorders are now planned.”
First up will be PORTICO, which is planned to start over the coming months in Spain and will include patients with BPD.
Several limitations
Commenting on the study for Medscape Medical News, Kolla, who is also a researcher at the Center for Addiction and Mental Health, noted that REIMAGINE was originally designed to test vafidemstat for the treatment of agitation and aggression in patients with Alzheimer’s disease (AD).
“It seems peculiar that the study investigators would choose to examine three additional psychiatric disorders that bear little resemblance to AD in terms of phenomenology. Additionally, the etiological underpinnings of the three disorders likely differ markedly from AD,” said Kolla, who was not involved with the research.
In addition, the “very small” sample size in each group makes it difficult to interpret the investigators’ conclusions, he noted.
There are also “many more sophisticated scales” to assess agitation and aggression than what were used in the study, he added.
Kolla also questioned the notion that a drug such as vafidemstat satisfies an unmet clinical need for the treatment of aggression and agitation.
Trials that “purport to reduce aggression in these populations often provide some level of global improvement in functioning that may appear as if they directly treat agitation or aggression,” he said. “However, no drug has ever been developed that directly reduces aggression and agitation.”
That means that, for now, there is insufficient evidence to “conclude that vafidemstat overcomes the unmet medical need of treating aggression/agitation,” he said.
For Kolla, the concept of a psychiatric drug that works by effecting epigenetic changes to the genome is also questionable, although such mechanisms may “play a role in the salubrious effects of certain mood stabilizers or antipsychotics for which better-defined mechanisms of action have been established.”
The study was funded by Oryzon Genomics. Bullock and the other investigators are employees of Oryzon Genomics.
This article first appeared on Medscape.com.
The novel lysine-specific demethylase 1 inhibitor vafidemstat (ORY-2001, Oryzon Genomics) is effective for treating agitation and aggression across a number of psychiatric disorders, new research suggests.
The REIMAGINE trial included 30 patients with autism spectrum disorder (ASD), ADHD, or borderline personality disorder (BPD). Results showed significant improvements after 8 weeks in general functioning and agitation-aggression scores for all three disorders.
The study “supports vafidemstat as an emerging therapeutic option to treat aggression-agitation, as well as the nonaggression features of psychiatric diseases with high unmet medical need,” lead researcher Roger Bullock, MD, Oryzon Genomics, Corneliá De Llobregat, Spain, told Medscape Medical News.
Bullock added.
However, another expert urged prudence when interpreting the findings.
“The study results must be viewed with caution, given the inherent limitations of an open-label trial, small sample size, and weak rationale for the sample selection,” said Nathan Kolla, MD, PhD, a psychiatrist at the University of Toronto, Canada, who was not involved with the research.
The findings were presented at the European Psychiatric Association (EPA) 2020 Congress, which was held online this year because of the COVID-19 pandemic.
Little evidence available
“Epigenetic mechanisms have been proposed in many psychiatric conditions, but so far, little clinical evidence is available,” Bullock said during his presentation.
In preclinical models, vafidemstat has been associated with a reduction in aggressive behavior “and the normal response to stress of immediate early genes in the prefrontal cortex” via the modification of gene transcription, noted Bullock.
“This new approach makes it a good candidate to look at aggression in multiple psychiatric and CNS conditions,” he added.
REIMAGINE was a phase 2a open-label trial that included 30 patients (53% women; mean age, 33.5 years; 87% White) with psychiatric disorders who had significant or persistent agitation or aggression that was disruptive of the patients› daily life.
Among the participants, 12 had BPD, 11 had ADHD, and seven had ASD. All were treated with vafidemstat 1.2 mg for 8 weeks.
In all, 23 patients completed all 8 weeks of treatment, including nine patients with BPD, eight with ADHD, and six with ASD.
Results showed that the study drug was well tolerated, with no serious adverse events reported and no patients withdrawing because of safety-related events.
The most common adverse events were headache (20%) and insomnia (10%), which resolved without intervention or treatment modification.
Significantly improved scores
Across the whole cohort, the drug was associated with significant reductions in scores over baseline on the Clinical Global Impression–Severity (CGI-S) and CGI-Improvement (CGI-I) scales. There were also significant improvements for Neuropsychiatric Inventory (NPI) total scores and agitation-aggression scores (P < .001 for comparisons).
Similar results were observed with respect to individual diagnoses, albeit at varying degrees of significance for each scale.
Patients with BPD experienced significant reductions in scores on the Borderline Personality Disorder Checklist (BPDCL) (P < .01). Patients with ADHD experienced reductions on the ADHD Rating Scale (P < .05).
Patients with BPD also experienced reductions in suicidal ideation, as measured with the Columbia Suicide Severity Rating Scale (P < .01). That is “the only cohort where this trait is relevant,” the researchers note.
In addition, significant correlations were shown between NPI total scores and scores on the BPDCL after treatment with vafidemstat (P = .015), as well as between NPI agitation-aggression scores and both CGI-I (P = .008) and CGI-S scores (P = .0001).
“This convergence of signals in scales of different nature and scope support the pharmacological role of vafidemstat in controlling aggression-agitation in different psychiatric conditions,” the investigators note.
Bullock added that further randomized placebo-controlled clinical trials “to confirm vafidemstat’s potential to treat aggression-agitation in psychiatric disorders are now planned.”
First up will be PORTICO, which is planned to start over the coming months in Spain and will include patients with BPD.
Several limitations
Commenting on the study for Medscape Medical News, Kolla, who is also a researcher at the Center for Addiction and Mental Health, noted that REIMAGINE was originally designed to test vafidemstat for the treatment of agitation and aggression in patients with Alzheimer’s disease (AD).
“It seems peculiar that the study investigators would choose to examine three additional psychiatric disorders that bear little resemblance to AD in terms of phenomenology. Additionally, the etiological underpinnings of the three disorders likely differ markedly from AD,” said Kolla, who was not involved with the research.
In addition, the “very small” sample size in each group makes it difficult to interpret the investigators’ conclusions, he noted.
There are also “many more sophisticated scales” to assess agitation and aggression than what were used in the study, he added.
Kolla also questioned the notion that a drug such as vafidemstat satisfies an unmet clinical need for the treatment of aggression and agitation.
Trials that “purport to reduce aggression in these populations often provide some level of global improvement in functioning that may appear as if they directly treat agitation or aggression,” he said. “However, no drug has ever been developed that directly reduces aggression and agitation.”
That means that, for now, there is insufficient evidence to “conclude that vafidemstat overcomes the unmet medical need of treating aggression/agitation,” he said.
For Kolla, the concept of a psychiatric drug that works by effecting epigenetic changes to the genome is also questionable, although such mechanisms may “play a role in the salubrious effects of certain mood stabilizers or antipsychotics for which better-defined mechanisms of action have been established.”
The study was funded by Oryzon Genomics. Bullock and the other investigators are employees of Oryzon Genomics.
This article first appeared on Medscape.com.
Lenalidomide may be an answer for refractory cutaneous lupus
Cutaneous lupus erythematosus (CLE) is present in 25% of patients with systemic lupus at the time of diagnosis, but it can also occur in up to 85% of cases at some point in their disease course, Eveline Y. Wu, MD, said during the virtual annual meeting of the Society for Pediatric Dermatology.
“CLE can also occur without any systemic disease,” said Dr. Wu, associate professor of pediatrics at the University of North Carolina at Chapel Hill. “It’s been shown that the risk of developing systemic lupus differs according to the type of skin involvement, meaning that cutaneous lupus can be classified into acute, subacute, chronic, and intermittent forms.”
Malar rash is the prototypical acute cutaneous lesion and is associated with active systemic lupus erythematosus (SLE) and anti–double stranded DNA antibody positivity, while discoid lupus erythematosus is the most common chronic lesion. “A small percentage of patients with discoid lupus can develop systemic lupus, particularly when the lesions are more disseminated,” said Dr. Wu, who specializes in pediatric rheumatology as well as allergy and immunology.
In the American College of Rheumatology’s 1997 classification system, mucocutaneous manifestations constitute 4 out of the 11 criteria that clinicians use to make a diagnosis of SLE: malar rash, discoid-lupus rash, photosensitivity, and oral or nasal mucocutaneous ulcerations. Dr. Wu recommends performing an oral exam on suspect cases, “because the oral ulcers that we see in systemic lupus tend to be painless, so oftentimes patients don’t realize they have them.”
Five other organ-specific manifestations of SLE include nonerosive arthritis, nephritis, encephalopathy, pleuritis or pericarditis, and cytopenia. The two other criteria are positive immunoserology and a positive antinuclear antibody test. “If you have any individuals present with one of these [mucocutaneous manifestations criteria], you want to think about getting a CBC to look for cytopenia or a urinalysis to look for evidence of nephritis, and potentially some additional blood studies, depending on your level of suspicion for systemic lupus,” Dr. Wu said.
Other rarer CLE manifestations include lupus pernio or chilblains, lupus panniculitis, livedo reticularis, bullous LE, urticarial vasculitis, neutrophilic dermatoses, and alopecia.
Common treatments for cutaneous manifestations associated pediatric SLE include hydroxychloroquine, low dose corticosteroids, topical steroids, methotrexate, and leflunomide. Other options for increasing severity of systemic disease include lenalidomide/thalidomide, azathioprine, calcineurin inhibitors, belimumab (Benlysta), high-dose corticosteroids, mycophenolate mofetil (CellCept), rituximab (Rituxan), and cyclophosphamide. Cutaneous manifestations of pediatric SLE can often be refractory to treatments.
In 2017, Dr. Wu and associates published a retrospective chart review of 10 adolescents who received lenalidomide for refractory CLE. One of the subjects was a 21-year-old male with a significant malar rash despite being on hydroxychloroquine, azathioprine, and prednisone 40 mg daily. “One month after being on lenalidomide he had a pretty impressive response,” Dr. Wu said. “It’s not quite clear how lenalidomide works in cutaneous lupus. Currently it’s only approved for use in myelodysplastic syndromes, multiple myeloma, as well as certain lymphomas. It’s thought to modulate different parts of the immune system, which collectively result in the cytotoxicity against tumor cells.”
Lenalidomide is supplied in capsule sizes ranging from 2.5 mg to 25 mg and is given once daily. “For a smaller child, I would think about starting 5 mg once a day,” Dr. Wu said. “For an adult-sized adolescent, you could start at 10 mg once a day and then titrate up based on response. Side effects that you need to worry about are cytopenia and GI symptoms. The venous and arterial thromboembolism risk has been seen in patients with multiple myeloma, and it is unclear if this risk is applicable to all indications.” Use of the medication requires enrollment into a safety monitoring program.
She reported having no financial disclosures.
Cutaneous lupus erythematosus (CLE) is present in 25% of patients with systemic lupus at the time of diagnosis, but it can also occur in up to 85% of cases at some point in their disease course, Eveline Y. Wu, MD, said during the virtual annual meeting of the Society for Pediatric Dermatology.
“CLE can also occur without any systemic disease,” said Dr. Wu, associate professor of pediatrics at the University of North Carolina at Chapel Hill. “It’s been shown that the risk of developing systemic lupus differs according to the type of skin involvement, meaning that cutaneous lupus can be classified into acute, subacute, chronic, and intermittent forms.”
Malar rash is the prototypical acute cutaneous lesion and is associated with active systemic lupus erythematosus (SLE) and anti–double stranded DNA antibody positivity, while discoid lupus erythematosus is the most common chronic lesion. “A small percentage of patients with discoid lupus can develop systemic lupus, particularly when the lesions are more disseminated,” said Dr. Wu, who specializes in pediatric rheumatology as well as allergy and immunology.
In the American College of Rheumatology’s 1997 classification system, mucocutaneous manifestations constitute 4 out of the 11 criteria that clinicians use to make a diagnosis of SLE: malar rash, discoid-lupus rash, photosensitivity, and oral or nasal mucocutaneous ulcerations. Dr. Wu recommends performing an oral exam on suspect cases, “because the oral ulcers that we see in systemic lupus tend to be painless, so oftentimes patients don’t realize they have them.”
Five other organ-specific manifestations of SLE include nonerosive arthritis, nephritis, encephalopathy, pleuritis or pericarditis, and cytopenia. The two other criteria are positive immunoserology and a positive antinuclear antibody test. “If you have any individuals present with one of these [mucocutaneous manifestations criteria], you want to think about getting a CBC to look for cytopenia or a urinalysis to look for evidence of nephritis, and potentially some additional blood studies, depending on your level of suspicion for systemic lupus,” Dr. Wu said.
Other rarer CLE manifestations include lupus pernio or chilblains, lupus panniculitis, livedo reticularis, bullous LE, urticarial vasculitis, neutrophilic dermatoses, and alopecia.
Common treatments for cutaneous manifestations associated pediatric SLE include hydroxychloroquine, low dose corticosteroids, topical steroids, methotrexate, and leflunomide. Other options for increasing severity of systemic disease include lenalidomide/thalidomide, azathioprine, calcineurin inhibitors, belimumab (Benlysta), high-dose corticosteroids, mycophenolate mofetil (CellCept), rituximab (Rituxan), and cyclophosphamide. Cutaneous manifestations of pediatric SLE can often be refractory to treatments.
In 2017, Dr. Wu and associates published a retrospective chart review of 10 adolescents who received lenalidomide for refractory CLE. One of the subjects was a 21-year-old male with a significant malar rash despite being on hydroxychloroquine, azathioprine, and prednisone 40 mg daily. “One month after being on lenalidomide he had a pretty impressive response,” Dr. Wu said. “It’s not quite clear how lenalidomide works in cutaneous lupus. Currently it’s only approved for use in myelodysplastic syndromes, multiple myeloma, as well as certain lymphomas. It’s thought to modulate different parts of the immune system, which collectively result in the cytotoxicity against tumor cells.”
Lenalidomide is supplied in capsule sizes ranging from 2.5 mg to 25 mg and is given once daily. “For a smaller child, I would think about starting 5 mg once a day,” Dr. Wu said. “For an adult-sized adolescent, you could start at 10 mg once a day and then titrate up based on response. Side effects that you need to worry about are cytopenia and GI symptoms. The venous and arterial thromboembolism risk has been seen in patients with multiple myeloma, and it is unclear if this risk is applicable to all indications.” Use of the medication requires enrollment into a safety monitoring program.
She reported having no financial disclosures.
Cutaneous lupus erythematosus (CLE) is present in 25% of patients with systemic lupus at the time of diagnosis, but it can also occur in up to 85% of cases at some point in their disease course, Eveline Y. Wu, MD, said during the virtual annual meeting of the Society for Pediatric Dermatology.
“CLE can also occur without any systemic disease,” said Dr. Wu, associate professor of pediatrics at the University of North Carolina at Chapel Hill. “It’s been shown that the risk of developing systemic lupus differs according to the type of skin involvement, meaning that cutaneous lupus can be classified into acute, subacute, chronic, and intermittent forms.”
Malar rash is the prototypical acute cutaneous lesion and is associated with active systemic lupus erythematosus (SLE) and anti–double stranded DNA antibody positivity, while discoid lupus erythematosus is the most common chronic lesion. “A small percentage of patients with discoid lupus can develop systemic lupus, particularly when the lesions are more disseminated,” said Dr. Wu, who specializes in pediatric rheumatology as well as allergy and immunology.
In the American College of Rheumatology’s 1997 classification system, mucocutaneous manifestations constitute 4 out of the 11 criteria that clinicians use to make a diagnosis of SLE: malar rash, discoid-lupus rash, photosensitivity, and oral or nasal mucocutaneous ulcerations. Dr. Wu recommends performing an oral exam on suspect cases, “because the oral ulcers that we see in systemic lupus tend to be painless, so oftentimes patients don’t realize they have them.”
Five other organ-specific manifestations of SLE include nonerosive arthritis, nephritis, encephalopathy, pleuritis or pericarditis, and cytopenia. The two other criteria are positive immunoserology and a positive antinuclear antibody test. “If you have any individuals present with one of these [mucocutaneous manifestations criteria], you want to think about getting a CBC to look for cytopenia or a urinalysis to look for evidence of nephritis, and potentially some additional blood studies, depending on your level of suspicion for systemic lupus,” Dr. Wu said.
Other rarer CLE manifestations include lupus pernio or chilblains, lupus panniculitis, livedo reticularis, bullous LE, urticarial vasculitis, neutrophilic dermatoses, and alopecia.
Common treatments for cutaneous manifestations associated pediatric SLE include hydroxychloroquine, low dose corticosteroids, topical steroids, methotrexate, and leflunomide. Other options for increasing severity of systemic disease include lenalidomide/thalidomide, azathioprine, calcineurin inhibitors, belimumab (Benlysta), high-dose corticosteroids, mycophenolate mofetil (CellCept), rituximab (Rituxan), and cyclophosphamide. Cutaneous manifestations of pediatric SLE can often be refractory to treatments.
In 2017, Dr. Wu and associates published a retrospective chart review of 10 adolescents who received lenalidomide for refractory CLE. One of the subjects was a 21-year-old male with a significant malar rash despite being on hydroxychloroquine, azathioprine, and prednisone 40 mg daily. “One month after being on lenalidomide he had a pretty impressive response,” Dr. Wu said. “It’s not quite clear how lenalidomide works in cutaneous lupus. Currently it’s only approved for use in myelodysplastic syndromes, multiple myeloma, as well as certain lymphomas. It’s thought to modulate different parts of the immune system, which collectively result in the cytotoxicity against tumor cells.”
Lenalidomide is supplied in capsule sizes ranging from 2.5 mg to 25 mg and is given once daily. “For a smaller child, I would think about starting 5 mg once a day,” Dr. Wu said. “For an adult-sized adolescent, you could start at 10 mg once a day and then titrate up based on response. Side effects that you need to worry about are cytopenia and GI symptoms. The venous and arterial thromboembolism risk has been seen in patients with multiple myeloma, and it is unclear if this risk is applicable to all indications.” Use of the medication requires enrollment into a safety monitoring program.
She reported having no financial disclosures.
FROM SPD 2020
New developments in pustular psoriasis
It has various dermatologic and rheumatologic manifestations and sometimes overlaps with plaque psoriasis. Pustular palmoplantar psoriasis (PPP) affects the palmar and plantar areas of the skin, while generalized pustular psoriasis (GPP) can affect large areas of skin and tends to be more severe, even life threatening. PPP can accompany psoriatic arthritis or can be a side effect of tumor necrosis factor (TNF) inhibitor therapy, or a non–drug-induced component of rheumatologic syndromes, according to Kristina Callis Duffin, MD, an associate professor and chair of dermatology at the University of Utah, Salt Lake City.
“Each phenotype could be considered an orphan disease, and the response to therapy is often unpredictable,” Dr. Duffin said during a session on pustular psoriasis at the virtual annual meeting of the Group for Research and Assessment of Psoriasis and Psoriatic Arthritis.
But there is some positive news. A study in 2011 of several people with GPP opened the door to better understanding the pathophysiology of pustular psoriasis. Researchers identified a causal autosomal mutation in the IL36RN gene, which encodes an antagonist to the interleukin-36 receptor (Am J Hum Genet. 2011 Sep 9;89[3]:432-7). “As a result of this paper and others, drug development in this space has recently accelerated,” Dr. Duffin said.
In fact, she added,“it’s my opinion that pustular psoriasis is now where plaque psoriasis was 20 years ago, when accelerated drug development was driving a better understanding of the pathogenesis of psoriatic disease and its comorbidities, and also driving outcome measure development.”
In another presentation at the meeting, Hervé Bachelez, MD, PhD, professor of dermatology and immunologist at the University of Paris and Saint-Louis Hospital, Paris, discussed recent advances in drug development for pustular psoriasis. He noted other recent findings of genetic variants related to the disease, including AP1S3, CARD14, and SERPINA3.
For GPP, he said, the current algorithm for management is based on weak evidence for treatments like acitretin, cyclosporine, methotrexate, and infliximab. The story is similar for other biologics, with evidence in the form of case series; open-label studies; controlled, prospective studies; or retrospective analyses. Most of the evidence has been amassed for TNF inhibitors. A retrospective study of all TNF inhibitors suggested they may be effective as induction and maintenance therapy, he noted.
Among IL-17A inhibitors, a prospective study of 12 patients in Japan found secukinumab showed efficacy against GPP, as did studies of ixekizumab and brodalumab. A small phase 3 study in Japan demonstrated efficacy for the IL-23 inhibitor guselkumab in patients with erythrodermic psoriasis and GPP (J Dermatol. 2018 May;45[5]:529-39).
The limited data are a reflection in part of the difficulty in studying GPP, since its flares tend to be more self-remitting than with psoriasis vulgaris or PPP.
There are two monoclonal antibodies against the IL-36 receptor currently being developed. A proof-of-concept study of one of them, spesolimab, showed promise against GPP, with five of seven patients reaching “clear” or “almost clear” scores on the Generalized Pustular Psoriasis Physician Global Assessment within a week after infusion and in all seven by the fourth week (N Engl J Med. 2019 Mar 7;380[10]:981-3).
With respect to PPP, the strongest evidence for conventional therapies comes from two randomized, controlled trials of cyclosporine, with response rates of 48% and 89%, compared with 19% and 21%, respectively, in the placebo groups, although the primary endpoint was poorly designed, according to Dr. Bachelez. Retinoids like etretinate and acitretin, combined with psoralen and UVA, also have some supporting evidence regarding efficacy.
Among biologics, secukinumab did not fare well in a phase 3 study of patients with PPP. A subset of patients may benefit from it, but there are no biomarkers available to identify them, Dr. Bachelez said. A phase 2 study of guselkumab in Japan told a similar story, with only weak signs of efficacy. While there are many more ongoing clinical trials evaluating treatments for PPP, which is encouraging, PPP seems to be more challenging at this stage to tackle than GPP, Dr. Bachelez added. “The genetically inherited IL-36 antagonist abnormalities are clearly driving the advances regarding the pathogenesis of the disease, mainly for GPP rather than PPP.”
Part of the efforts to develop therapies for pustular psoriasis relies on the development of new outcome measures, or adaptation of existing ones. “We have a need to adapt or develop new investigator-reported measures, we need to adapt or develop new patient-reported outcomes,” Dr. Duffin said.
Many existing measures use inconsistent language and anchoring definitions, and some may be proprietary, she added. “The language varies by sponsor and is sometimes tweaked or modified by the agencies. Often synonyms are being used … it raises questions, does it change the validity of the instrument?”
Dr. Duffin called for the research community to use the pause in clinical research during the COVID-19 pandemic to reassess the research agenda, develop consensus on performing and training for GPP and PPP assessments, develop patient-reported outcomes, and strengthen connections to industry.
Dr. Duffin and Dr. Bachelez have consulted, served on the advisory board, been a speaker for, and/or received research support from a wide range of pharmaceutical companies, including those that manufacture and develop psoriasis treatments.
It has various dermatologic and rheumatologic manifestations and sometimes overlaps with plaque psoriasis. Pustular palmoplantar psoriasis (PPP) affects the palmar and plantar areas of the skin, while generalized pustular psoriasis (GPP) can affect large areas of skin and tends to be more severe, even life threatening. PPP can accompany psoriatic arthritis or can be a side effect of tumor necrosis factor (TNF) inhibitor therapy, or a non–drug-induced component of rheumatologic syndromes, according to Kristina Callis Duffin, MD, an associate professor and chair of dermatology at the University of Utah, Salt Lake City.
“Each phenotype could be considered an orphan disease, and the response to therapy is often unpredictable,” Dr. Duffin said during a session on pustular psoriasis at the virtual annual meeting of the Group for Research and Assessment of Psoriasis and Psoriatic Arthritis.
But there is some positive news. A study in 2011 of several people with GPP opened the door to better understanding the pathophysiology of pustular psoriasis. Researchers identified a causal autosomal mutation in the IL36RN gene, which encodes an antagonist to the interleukin-36 receptor (Am J Hum Genet. 2011 Sep 9;89[3]:432-7). “As a result of this paper and others, drug development in this space has recently accelerated,” Dr. Duffin said.
In fact, she added,“it’s my opinion that pustular psoriasis is now where plaque psoriasis was 20 years ago, when accelerated drug development was driving a better understanding of the pathogenesis of psoriatic disease and its comorbidities, and also driving outcome measure development.”
In another presentation at the meeting, Hervé Bachelez, MD, PhD, professor of dermatology and immunologist at the University of Paris and Saint-Louis Hospital, Paris, discussed recent advances in drug development for pustular psoriasis. He noted other recent findings of genetic variants related to the disease, including AP1S3, CARD14, and SERPINA3.
For GPP, he said, the current algorithm for management is based on weak evidence for treatments like acitretin, cyclosporine, methotrexate, and infliximab. The story is similar for other biologics, with evidence in the form of case series; open-label studies; controlled, prospective studies; or retrospective analyses. Most of the evidence has been amassed for TNF inhibitors. A retrospective study of all TNF inhibitors suggested they may be effective as induction and maintenance therapy, he noted.
Among IL-17A inhibitors, a prospective study of 12 patients in Japan found secukinumab showed efficacy against GPP, as did studies of ixekizumab and brodalumab. A small phase 3 study in Japan demonstrated efficacy for the IL-23 inhibitor guselkumab in patients with erythrodermic psoriasis and GPP (J Dermatol. 2018 May;45[5]:529-39).
The limited data are a reflection in part of the difficulty in studying GPP, since its flares tend to be more self-remitting than with psoriasis vulgaris or PPP.
There are two monoclonal antibodies against the IL-36 receptor currently being developed. A proof-of-concept study of one of them, spesolimab, showed promise against GPP, with five of seven patients reaching “clear” or “almost clear” scores on the Generalized Pustular Psoriasis Physician Global Assessment within a week after infusion and in all seven by the fourth week (N Engl J Med. 2019 Mar 7;380[10]:981-3).
With respect to PPP, the strongest evidence for conventional therapies comes from two randomized, controlled trials of cyclosporine, with response rates of 48% and 89%, compared with 19% and 21%, respectively, in the placebo groups, although the primary endpoint was poorly designed, according to Dr. Bachelez. Retinoids like etretinate and acitretin, combined with psoralen and UVA, also have some supporting evidence regarding efficacy.
Among biologics, secukinumab did not fare well in a phase 3 study of patients with PPP. A subset of patients may benefit from it, but there are no biomarkers available to identify them, Dr. Bachelez said. A phase 2 study of guselkumab in Japan told a similar story, with only weak signs of efficacy. While there are many more ongoing clinical trials evaluating treatments for PPP, which is encouraging, PPP seems to be more challenging at this stage to tackle than GPP, Dr. Bachelez added. “The genetically inherited IL-36 antagonist abnormalities are clearly driving the advances regarding the pathogenesis of the disease, mainly for GPP rather than PPP.”
Part of the efforts to develop therapies for pustular psoriasis relies on the development of new outcome measures, or adaptation of existing ones. “We have a need to adapt or develop new investigator-reported measures, we need to adapt or develop new patient-reported outcomes,” Dr. Duffin said.
Many existing measures use inconsistent language and anchoring definitions, and some may be proprietary, she added. “The language varies by sponsor and is sometimes tweaked or modified by the agencies. Often synonyms are being used … it raises questions, does it change the validity of the instrument?”
Dr. Duffin called for the research community to use the pause in clinical research during the COVID-19 pandemic to reassess the research agenda, develop consensus on performing and training for GPP and PPP assessments, develop patient-reported outcomes, and strengthen connections to industry.
Dr. Duffin and Dr. Bachelez have consulted, served on the advisory board, been a speaker for, and/or received research support from a wide range of pharmaceutical companies, including those that manufacture and develop psoriasis treatments.
It has various dermatologic and rheumatologic manifestations and sometimes overlaps with plaque psoriasis. Pustular palmoplantar psoriasis (PPP) affects the palmar and plantar areas of the skin, while generalized pustular psoriasis (GPP) can affect large areas of skin and tends to be more severe, even life threatening. PPP can accompany psoriatic arthritis or can be a side effect of tumor necrosis factor (TNF) inhibitor therapy, or a non–drug-induced component of rheumatologic syndromes, according to Kristina Callis Duffin, MD, an associate professor and chair of dermatology at the University of Utah, Salt Lake City.
“Each phenotype could be considered an orphan disease, and the response to therapy is often unpredictable,” Dr. Duffin said during a session on pustular psoriasis at the virtual annual meeting of the Group for Research and Assessment of Psoriasis and Psoriatic Arthritis.
But there is some positive news. A study in 2011 of several people with GPP opened the door to better understanding the pathophysiology of pustular psoriasis. Researchers identified a causal autosomal mutation in the IL36RN gene, which encodes an antagonist to the interleukin-36 receptor (Am J Hum Genet. 2011 Sep 9;89[3]:432-7). “As a result of this paper and others, drug development in this space has recently accelerated,” Dr. Duffin said.
In fact, she added,“it’s my opinion that pustular psoriasis is now where plaque psoriasis was 20 years ago, when accelerated drug development was driving a better understanding of the pathogenesis of psoriatic disease and its comorbidities, and also driving outcome measure development.”
In another presentation at the meeting, Hervé Bachelez, MD, PhD, professor of dermatology and immunologist at the University of Paris and Saint-Louis Hospital, Paris, discussed recent advances in drug development for pustular psoriasis. He noted other recent findings of genetic variants related to the disease, including AP1S3, CARD14, and SERPINA3.
For GPP, he said, the current algorithm for management is based on weak evidence for treatments like acitretin, cyclosporine, methotrexate, and infliximab. The story is similar for other biologics, with evidence in the form of case series; open-label studies; controlled, prospective studies; or retrospective analyses. Most of the evidence has been amassed for TNF inhibitors. A retrospective study of all TNF inhibitors suggested they may be effective as induction and maintenance therapy, he noted.
Among IL-17A inhibitors, a prospective study of 12 patients in Japan found secukinumab showed efficacy against GPP, as did studies of ixekizumab and brodalumab. A small phase 3 study in Japan demonstrated efficacy for the IL-23 inhibitor guselkumab in patients with erythrodermic psoriasis and GPP (J Dermatol. 2018 May;45[5]:529-39).
The limited data are a reflection in part of the difficulty in studying GPP, since its flares tend to be more self-remitting than with psoriasis vulgaris or PPP.
There are two monoclonal antibodies against the IL-36 receptor currently being developed. A proof-of-concept study of one of them, spesolimab, showed promise against GPP, with five of seven patients reaching “clear” or “almost clear” scores on the Generalized Pustular Psoriasis Physician Global Assessment within a week after infusion and in all seven by the fourth week (N Engl J Med. 2019 Mar 7;380[10]:981-3).
With respect to PPP, the strongest evidence for conventional therapies comes from two randomized, controlled trials of cyclosporine, with response rates of 48% and 89%, compared with 19% and 21%, respectively, in the placebo groups, although the primary endpoint was poorly designed, according to Dr. Bachelez. Retinoids like etretinate and acitretin, combined with psoralen and UVA, also have some supporting evidence regarding efficacy.
Among biologics, secukinumab did not fare well in a phase 3 study of patients with PPP. A subset of patients may benefit from it, but there are no biomarkers available to identify them, Dr. Bachelez said. A phase 2 study of guselkumab in Japan told a similar story, with only weak signs of efficacy. While there are many more ongoing clinical trials evaluating treatments for PPP, which is encouraging, PPP seems to be more challenging at this stage to tackle than GPP, Dr. Bachelez added. “The genetically inherited IL-36 antagonist abnormalities are clearly driving the advances regarding the pathogenesis of the disease, mainly for GPP rather than PPP.”
Part of the efforts to develop therapies for pustular psoriasis relies on the development of new outcome measures, or adaptation of existing ones. “We have a need to adapt or develop new investigator-reported measures, we need to adapt or develop new patient-reported outcomes,” Dr. Duffin said.
Many existing measures use inconsistent language and anchoring definitions, and some may be proprietary, she added. “The language varies by sponsor and is sometimes tweaked or modified by the agencies. Often synonyms are being used … it raises questions, does it change the validity of the instrument?”
Dr. Duffin called for the research community to use the pause in clinical research during the COVID-19 pandemic to reassess the research agenda, develop consensus on performing and training for GPP and PPP assessments, develop patient-reported outcomes, and strengthen connections to industry.
Dr. Duffin and Dr. Bachelez have consulted, served on the advisory board, been a speaker for, and/or received research support from a wide range of pharmaceutical companies, including those that manufacture and develop psoriasis treatments.
FROM THE GRAPPA 2020 VIRTUAL ANNUAL MEETING
Patch testing in children: An evolving science
“Time needs to be allocated for a patch test consultation, placement, removal, and reading,” she said at the virtual annual meeting of the Society for Pediatric Dermatology. “You will need more time in the day that you’re reading the patch test for patient education. However, your staff will need more time on the front end of the patch test process for application. Also, if they are customizing patch tests, they’ll need time to make the patch tests along with access to a refrigerator and plenty of counter space.”
Other factors to consider are the site of service, your payer mix, and if you need to complete prior authorizations for patch testing.
Dr. Martin, associate professor of dermatology and child health at the University of Missouri–Columbia, said that the diagnosis of allergic contact dermatitis (ACD) crosses her mind when she sees a patient with new dermatitis, especially in an older child; if the dermatitis is patterned or regional; if there’s exacerbation of an underlying, previously stable skin disease; or if it’s a pattern known to be associated with systemic contact dermatitis. “In fact, 13%-25% of healthy, asymptomatic kids have allergen sensitization,” she said. “If you take that a step further and look at kids who are suspected of having allergic contact dermatitis, 25%-96% have allergen sensitization. Still, that doesn’t mean that those tests are relevant to the dermatitis that’s going on. If you take kids who are referred to tertiary centers for patch testing, about half will have relevant patch test results.”
Pediatric ACD differs from adult ACD in three ways, Dr. Martin said. First, children have a different clinical morphology and distribution on presentation, compared with adults. “In adults, the most common clinical presentation is hand dermatitis, while kids more often present with a scattered generalized morphology of dermatitis,” she said. “This occurs in about one-third of children with ACD. Their patterns of allergen exposure are also different. For the most part, adults are in control of their own environments and what is placed on their skin, whereas kids are not. When thinking about what you might need to patch test a child to if you’re considering ACD, it’s important to think about not only what the parent or caregiver puts directly on the child’s skin but also any connubial or consort allergen exposure – the most common ones coming from the caregivers themselves, such as fragrance or hair dyes that are transferred to a young child.”
The third factor that differs between pediatric and adult ACD is the allergen source. Dr. Martin noted that children and adults use different personal care products, wear different types of clothing, and spend different amounts of time in play versus work. “Children have many more hobbies in general that are unfortunately lost as many of us age,” she said. That means “thinking through the child’s entire day and how the seasons differ for them, such as what sports they’re in and what protective equipment may be involved with where their dermatitis is, or what musical instruments they play.”
Applying the T.R.U.E. patch test panel or a customized patch test panel to young children poses certain challenges, considering their limited body surface area and propensity to squirm. Dr. Martin often employs distraction techniques when placing patches on young patients, including the use of bubbles, music, movies, and games. “The goal is always to get as much of the patches on the back or the flanks as possible,” she said. “If you need additional space you can use the upper outer arms, the abdomen, or the anterior lateral thighs. Another thing to consider is how to set up your week for pediatric patch testing. There’s a standardized process for adults where we place the patches on day 0, read them on day 2, with removal of the patches at that time, and then perform a delayed read between day 4-7.”
The process is similar for postpubescent children, despite the lack of clear guidelines in the medical literature. “There is much controversy and different practices between different pediatric patch test centers,” Dr. Martin said. “There is more consensus between the older kids and the prepubescent group ages 6-12. Most clinicians will still do a similar placement on day 0 with removal and initial read on day 2, with a delayed read on day 4-7. However, some groups will remove patches at 24 hours, especially in those with atopic dermatitis (AD) or a generalized dermatitis, to reduce irritant reactions. Others will also use half-strength concentrations of allergens.”
The most controversy lies with children younger than 6 years, she said. For those aged 3-6 years, who do not have AD, most practices use a standardized pediatric tray with a 24- to 48-hour contact time. However, patch testing can be “very challenging” for children who are under 3 years of age, and children with AD who are under 6 years, “so there needs to be a very high degree of suspicion for ACD and very careful selection of the allergens and contact time that is used in those particular cases,” she noted.
The most common allergens in children are nickel, fragrance mix I, cobalt, balsam of Peru, neomycin, and bacitracin, which largely match the common allergens seen in adults. However, allergens more common in children, compared with adults, include gold, propylene glycol, 2-Bromo-2-nitropropane-1,3-diol, and cocamidopropyl betaine. “If the child presents with a regional dermatitis or a patterned dermatitis, sometimes you can hone in on your suspected allergens and only test for a few,” Dr. Martin said. “In a child with eyelid dermatitis, you’re going to worry more about cocamidopropyl betaine in their shampoos and cleansers. Also, a metal allergen could be transferred from their hands from toys or coins, specifically nickel and cobalt. They also may have different sports gear such as goggles that may be affecting their eyelid dermatitis, which you would not necessarily see in an adult.”
Periorificial contact dermatitis can also differ in presentation between children and adults. “In kids, think about musical instruments, flavored lip balms, gum, and pacifiers,” she said. “For ACD on the buttocks and posterior thighs, think about toilet seat allergens, especially those in the potty training ages, and the nickel bolts on school chairs.”
In 2018, Dr. Martin and her colleagues on the Pediatric Contact Dermatitis Workgroup published a pediatric baseline patch test series as a way to expand on the T.R.U.E. test (Dermatitis. 2018;29[4]:206-12). “It’s nice to have this panel available as a baseline screening tool when you’re unsure of possible triggers of the dermatitis but you still have high suspicion of allergic dermatitis,” Dr. Martin said. “This also is helpful for patients who present with generalized dermatitis. It’s still not perfect. We are collecting prospective data to fine-tune this baseline series.”
She reported having no financial disclosures.
“Time needs to be allocated for a patch test consultation, placement, removal, and reading,” she said at the virtual annual meeting of the Society for Pediatric Dermatology. “You will need more time in the day that you’re reading the patch test for patient education. However, your staff will need more time on the front end of the patch test process for application. Also, if they are customizing patch tests, they’ll need time to make the patch tests along with access to a refrigerator and plenty of counter space.”
Other factors to consider are the site of service, your payer mix, and if you need to complete prior authorizations for patch testing.
Dr. Martin, associate professor of dermatology and child health at the University of Missouri–Columbia, said that the diagnosis of allergic contact dermatitis (ACD) crosses her mind when she sees a patient with new dermatitis, especially in an older child; if the dermatitis is patterned or regional; if there’s exacerbation of an underlying, previously stable skin disease; or if it’s a pattern known to be associated with systemic contact dermatitis. “In fact, 13%-25% of healthy, asymptomatic kids have allergen sensitization,” she said. “If you take that a step further and look at kids who are suspected of having allergic contact dermatitis, 25%-96% have allergen sensitization. Still, that doesn’t mean that those tests are relevant to the dermatitis that’s going on. If you take kids who are referred to tertiary centers for patch testing, about half will have relevant patch test results.”
Pediatric ACD differs from adult ACD in three ways, Dr. Martin said. First, children have a different clinical morphology and distribution on presentation, compared with adults. “In adults, the most common clinical presentation is hand dermatitis, while kids more often present with a scattered generalized morphology of dermatitis,” she said. “This occurs in about one-third of children with ACD. Their patterns of allergen exposure are also different. For the most part, adults are in control of their own environments and what is placed on their skin, whereas kids are not. When thinking about what you might need to patch test a child to if you’re considering ACD, it’s important to think about not only what the parent or caregiver puts directly on the child’s skin but also any connubial or consort allergen exposure – the most common ones coming from the caregivers themselves, such as fragrance or hair dyes that are transferred to a young child.”
The third factor that differs between pediatric and adult ACD is the allergen source. Dr. Martin noted that children and adults use different personal care products, wear different types of clothing, and spend different amounts of time in play versus work. “Children have many more hobbies in general that are unfortunately lost as many of us age,” she said. That means “thinking through the child’s entire day and how the seasons differ for them, such as what sports they’re in and what protective equipment may be involved with where their dermatitis is, or what musical instruments they play.”
Applying the T.R.U.E. patch test panel or a customized patch test panel to young children poses certain challenges, considering their limited body surface area and propensity to squirm. Dr. Martin often employs distraction techniques when placing patches on young patients, including the use of bubbles, music, movies, and games. “The goal is always to get as much of the patches on the back or the flanks as possible,” she said. “If you need additional space you can use the upper outer arms, the abdomen, or the anterior lateral thighs. Another thing to consider is how to set up your week for pediatric patch testing. There’s a standardized process for adults where we place the patches on day 0, read them on day 2, with removal of the patches at that time, and then perform a delayed read between day 4-7.”
The process is similar for postpubescent children, despite the lack of clear guidelines in the medical literature. “There is much controversy and different practices between different pediatric patch test centers,” Dr. Martin said. “There is more consensus between the older kids and the prepubescent group ages 6-12. Most clinicians will still do a similar placement on day 0 with removal and initial read on day 2, with a delayed read on day 4-7. However, some groups will remove patches at 24 hours, especially in those with atopic dermatitis (AD) or a generalized dermatitis, to reduce irritant reactions. Others will also use half-strength concentrations of allergens.”
The most controversy lies with children younger than 6 years, she said. For those aged 3-6 years, who do not have AD, most practices use a standardized pediatric tray with a 24- to 48-hour contact time. However, patch testing can be “very challenging” for children who are under 3 years of age, and children with AD who are under 6 years, “so there needs to be a very high degree of suspicion for ACD and very careful selection of the allergens and contact time that is used in those particular cases,” she noted.
The most common allergens in children are nickel, fragrance mix I, cobalt, balsam of Peru, neomycin, and bacitracin, which largely match the common allergens seen in adults. However, allergens more common in children, compared with adults, include gold, propylene glycol, 2-Bromo-2-nitropropane-1,3-diol, and cocamidopropyl betaine. “If the child presents with a regional dermatitis or a patterned dermatitis, sometimes you can hone in on your suspected allergens and only test for a few,” Dr. Martin said. “In a child with eyelid dermatitis, you’re going to worry more about cocamidopropyl betaine in their shampoos and cleansers. Also, a metal allergen could be transferred from their hands from toys or coins, specifically nickel and cobalt. They also may have different sports gear such as goggles that may be affecting their eyelid dermatitis, which you would not necessarily see in an adult.”
Periorificial contact dermatitis can also differ in presentation between children and adults. “In kids, think about musical instruments, flavored lip balms, gum, and pacifiers,” she said. “For ACD on the buttocks and posterior thighs, think about toilet seat allergens, especially those in the potty training ages, and the nickel bolts on school chairs.”
In 2018, Dr. Martin and her colleagues on the Pediatric Contact Dermatitis Workgroup published a pediatric baseline patch test series as a way to expand on the T.R.U.E. test (Dermatitis. 2018;29[4]:206-12). “It’s nice to have this panel available as a baseline screening tool when you’re unsure of possible triggers of the dermatitis but you still have high suspicion of allergic dermatitis,” Dr. Martin said. “This also is helpful for patients who present with generalized dermatitis. It’s still not perfect. We are collecting prospective data to fine-tune this baseline series.”
She reported having no financial disclosures.
“Time needs to be allocated for a patch test consultation, placement, removal, and reading,” she said at the virtual annual meeting of the Society for Pediatric Dermatology. “You will need more time in the day that you’re reading the patch test for patient education. However, your staff will need more time on the front end of the patch test process for application. Also, if they are customizing patch tests, they’ll need time to make the patch tests along with access to a refrigerator and plenty of counter space.”
Other factors to consider are the site of service, your payer mix, and if you need to complete prior authorizations for patch testing.
Dr. Martin, associate professor of dermatology and child health at the University of Missouri–Columbia, said that the diagnosis of allergic contact dermatitis (ACD) crosses her mind when she sees a patient with new dermatitis, especially in an older child; if the dermatitis is patterned or regional; if there’s exacerbation of an underlying, previously stable skin disease; or if it’s a pattern known to be associated with systemic contact dermatitis. “In fact, 13%-25% of healthy, asymptomatic kids have allergen sensitization,” she said. “If you take that a step further and look at kids who are suspected of having allergic contact dermatitis, 25%-96% have allergen sensitization. Still, that doesn’t mean that those tests are relevant to the dermatitis that’s going on. If you take kids who are referred to tertiary centers for patch testing, about half will have relevant patch test results.”
Pediatric ACD differs from adult ACD in three ways, Dr. Martin said. First, children have a different clinical morphology and distribution on presentation, compared with adults. “In adults, the most common clinical presentation is hand dermatitis, while kids more often present with a scattered generalized morphology of dermatitis,” she said. “This occurs in about one-third of children with ACD. Their patterns of allergen exposure are also different. For the most part, adults are in control of their own environments and what is placed on their skin, whereas kids are not. When thinking about what you might need to patch test a child to if you’re considering ACD, it’s important to think about not only what the parent or caregiver puts directly on the child’s skin but also any connubial or consort allergen exposure – the most common ones coming from the caregivers themselves, such as fragrance or hair dyes that are transferred to a young child.”
The third factor that differs between pediatric and adult ACD is the allergen source. Dr. Martin noted that children and adults use different personal care products, wear different types of clothing, and spend different amounts of time in play versus work. “Children have many more hobbies in general that are unfortunately lost as many of us age,” she said. That means “thinking through the child’s entire day and how the seasons differ for them, such as what sports they’re in and what protective equipment may be involved with where their dermatitis is, or what musical instruments they play.”
Applying the T.R.U.E. patch test panel or a customized patch test panel to young children poses certain challenges, considering their limited body surface area and propensity to squirm. Dr. Martin often employs distraction techniques when placing patches on young patients, including the use of bubbles, music, movies, and games. “The goal is always to get as much of the patches on the back or the flanks as possible,” she said. “If you need additional space you can use the upper outer arms, the abdomen, or the anterior lateral thighs. Another thing to consider is how to set up your week for pediatric patch testing. There’s a standardized process for adults where we place the patches on day 0, read them on day 2, with removal of the patches at that time, and then perform a delayed read between day 4-7.”
The process is similar for postpubescent children, despite the lack of clear guidelines in the medical literature. “There is much controversy and different practices between different pediatric patch test centers,” Dr. Martin said. “There is more consensus between the older kids and the prepubescent group ages 6-12. Most clinicians will still do a similar placement on day 0 with removal and initial read on day 2, with a delayed read on day 4-7. However, some groups will remove patches at 24 hours, especially in those with atopic dermatitis (AD) or a generalized dermatitis, to reduce irritant reactions. Others will also use half-strength concentrations of allergens.”
The most controversy lies with children younger than 6 years, she said. For those aged 3-6 years, who do not have AD, most practices use a standardized pediatric tray with a 24- to 48-hour contact time. However, patch testing can be “very challenging” for children who are under 3 years of age, and children with AD who are under 6 years, “so there needs to be a very high degree of suspicion for ACD and very careful selection of the allergens and contact time that is used in those particular cases,” she noted.
The most common allergens in children are nickel, fragrance mix I, cobalt, balsam of Peru, neomycin, and bacitracin, which largely match the common allergens seen in adults. However, allergens more common in children, compared with adults, include gold, propylene glycol, 2-Bromo-2-nitropropane-1,3-diol, and cocamidopropyl betaine. “If the child presents with a regional dermatitis or a patterned dermatitis, sometimes you can hone in on your suspected allergens and only test for a few,” Dr. Martin said. “In a child with eyelid dermatitis, you’re going to worry more about cocamidopropyl betaine in their shampoos and cleansers. Also, a metal allergen could be transferred from their hands from toys or coins, specifically nickel and cobalt. They also may have different sports gear such as goggles that may be affecting their eyelid dermatitis, which you would not necessarily see in an adult.”
Periorificial contact dermatitis can also differ in presentation between children and adults. “In kids, think about musical instruments, flavored lip balms, gum, and pacifiers,” she said. “For ACD on the buttocks and posterior thighs, think about toilet seat allergens, especially those in the potty training ages, and the nickel bolts on school chairs.”
In 2018, Dr. Martin and her colleagues on the Pediatric Contact Dermatitis Workgroup published a pediatric baseline patch test series as a way to expand on the T.R.U.E. test (Dermatitis. 2018;29[4]:206-12). “It’s nice to have this panel available as a baseline screening tool when you’re unsure of possible triggers of the dermatitis but you still have high suspicion of allergic dermatitis,” Dr. Martin said. “This also is helpful for patients who present with generalized dermatitis. It’s still not perfect. We are collecting prospective data to fine-tune this baseline series.”
She reported having no financial disclosures.
FROM SPD 2020
Stress, COVID-19 contribute to mental health concerns in college students
Socioeconomic, technological, cultural, and historical conditions are contributing to a mental health crisis among college students in the United States, according to Anthony L. Rostain, MD, MA, in a virtual meeting presented by Current Psychiatry and the American Academy of Clinical Psychiatrists.
A recent National College Health Assessment published in fall of 2018 by the American College Health Association found that one in four college students had some kind of diagnosable mental illness, and 44% had symptoms of depression within the past year.
The assessment also found that college students felt overwhelmed (86%), felt sad (68%), felt very lonely (63%), had overwhelming anxiety (62%), experienced feelings of hopelessness (53%), or were depressed to the point where functioning was difficult (41%), all of which was higher than in previous years. Students also were more likely than in previous years to engage in interpersonal violence (17%), seriously consider suicide (11%), intentionally hurt themselves (7.4%), and attempt suicide (1.9%). According to the organization Active Minds, suicide is a leading cause of death in college students.
This shift in mental health for individuals in Generation Z, those born between the mid-1990s and early 2010s, can be attributed to historical events since the turn of the century, Dr. Rostain said at the meeting, presented by Global Academy for Medical Education. The Sept. 11, 2001, attacks, wars in Iraq and Afghanistan, the financial crisis of 2007-2008, school shootings, globalization leading to economic uncertainty, the 24-hour news cycle and continuous media exposure, and the influence of the Internet have all influenced Gen Z’s identity.
“Growing up immersed in the Internet certainly has its advantages, but also maybe created some vulnerabilities in our young people,” he said.
Concerns about climate change, the burden of higher education and student debt, and the COVID-19 pandemic also have contributed to anxiety in this group. In a spring survey of students published by Active Minds about COVID-19 and its impact on mental health, 91% of students reported having stress or anxiety, 81% were disappointed or sad, 80% said they felt lonely or isolated, 56% had relocated as a result of the pandemic, and 48% reported financial setbacks tied to COVID-19.
“Anxiety seems to have become a feature of modern life,” said Dr. Rostain, who is director of education at the department of psychiatry and professor of psychiatry at the Hospital of the University of Pennsylvania in Philadelphia.
“Our culture, which often has a prominent emotional tone of fear, tends to promote cognitive distortions in which everyone is perceiving danger at every turn.” in this group, he noted. While people should be washing their hands and staying safe through social distancing during the pandemic, “we don’t want people to stop functioning, planning the future, and really in college students’ case, studying and getting ready for their careers,” he said. Parents can hinder those goals through intensively parenting or “overparenting” their children, which can result in destructive perfectionism, anxiety and depression, abject fear of failure and risk avoidance, and a focus on the external aspects of life rather than internal feelings.
Heavier alcohol use and amphetamine use also is on the rise in college students, Dr. Rostain said. Increased stimulant use in young adults is attributed to greater access to prescription drugs prior to college, greater prevalence of attention-deficit/hyperactivity disorder (ADHD), peer pressure, and influence from marketing and media messaging, he said. Another important change is the rise of smartphones and the Internet, which might drive the need to be constantly connected and compete for attention.
“This is the first generation who had constant access to the Internet. Smartphones in particular are everywhere, and we think this is another important factor in considering what might be happening to young people,” Dr. Rostain said.
Developing problem-solving and conflict resolution skills, developing coping mechanisms, being able to regulate emotions, finding optimism toward the future, having access to mental health services, and having cultural or religious beliefs with a negative view of suicide are all protective factors that promote resiliency in young people, Dr. Rostain said. Other protective factors include the development of socio-emotional readiness skills, such as conscientiousness, self-management, interpersonal skills, self-control, task persistence, risk management, self-acceptance, and having an open mindset or seeking help when needed. However, he noted, family is one area that can be both a help or a risk to mental health.
“Family attachments and supportive relationships in the family are really critical in predicting good outcomes. By the same token, families that are conflicted, where there’s a lot of stress or there’s a lot of turmoil and/or where resources are not available, that may be a risk factor to coping in young adulthood,” he said.
Individual resilience can be developed through learning from mistakes and overcoming mindset barriers, such as feelings of not belonging, concerns about disappointing one’s parents, worries about not making it, or fears of being different.
On campus, best practices and emerging trends include wellness and resiliency programs, reducing stigma, engagement from students, training of faculty and staff, crisis management plans, telehealth counseling, substance abuse programs, postvention support after suicide, collaboration with mental health providers, and support for diverse populations.
“The best schools are the ones that promote communication and that invite families to be involved early on because parents and families can be and need to be educated about what to do to prevent adverse outcomes of young people who are really at risk,” Dr. Rostain said. “It takes a village to raise a child, and it takes the same village to bring someone from adolescence to young adulthood.”
Family-based intervention has also shown promise, he said, but clinicians should watch for signs that a family is not willing to undergo therapy, is scapegoating a college student, or there are signs of boundary violations, violence, or sexual abuse in the family – or attempts to undermine treatment.
Specific to COVID-19, campus mental health services should focus on routine, self-care, physical activity, and connections with other people while also space for grieving lost experiences, facing uncertainty, developing resilience, and finding meaning. In the family, challenges around COVID-19 can include issues of physical distancing and quarantine, anxiety about becoming infected with the virus, economic insecurity, managing conflicts, setting and enforcing boundaries in addition to providing mutual support, and finding new meaning during the pandemic.
“I think these are the challenges, but we think this whole process of people living together and handling life in a way they’ve never expected to may hold some silver linings,” Dr. Rostain said. “It may be a way of addressing many issues that were never addressed before the young person went off to college.”
Global Academy and this news organization are owned by the same parent company. Dr. Rostain reported receiving royalties from Routledge/Taylor Francis Group and St. Martin’s Press, scientific advisory board honoraria from Arbor and Shire/Takeda, consulting fees from the National Football League and Tris Pharmaceuticals, and has presented CME sessions for American Psychiatric Publishing, Global Medical Education, Shire/Takeda, and the U.S. Psychiatric Congress.
Socioeconomic, technological, cultural, and historical conditions are contributing to a mental health crisis among college students in the United States, according to Anthony L. Rostain, MD, MA, in a virtual meeting presented by Current Psychiatry and the American Academy of Clinical Psychiatrists.
A recent National College Health Assessment published in fall of 2018 by the American College Health Association found that one in four college students had some kind of diagnosable mental illness, and 44% had symptoms of depression within the past year.
The assessment also found that college students felt overwhelmed (86%), felt sad (68%), felt very lonely (63%), had overwhelming anxiety (62%), experienced feelings of hopelessness (53%), or were depressed to the point where functioning was difficult (41%), all of which was higher than in previous years. Students also were more likely than in previous years to engage in interpersonal violence (17%), seriously consider suicide (11%), intentionally hurt themselves (7.4%), and attempt suicide (1.9%). According to the organization Active Minds, suicide is a leading cause of death in college students.
This shift in mental health for individuals in Generation Z, those born between the mid-1990s and early 2010s, can be attributed to historical events since the turn of the century, Dr. Rostain said at the meeting, presented by Global Academy for Medical Education. The Sept. 11, 2001, attacks, wars in Iraq and Afghanistan, the financial crisis of 2007-2008, school shootings, globalization leading to economic uncertainty, the 24-hour news cycle and continuous media exposure, and the influence of the Internet have all influenced Gen Z’s identity.
“Growing up immersed in the Internet certainly has its advantages, but also maybe created some vulnerabilities in our young people,” he said.
Concerns about climate change, the burden of higher education and student debt, and the COVID-19 pandemic also have contributed to anxiety in this group. In a spring survey of students published by Active Minds about COVID-19 and its impact on mental health, 91% of students reported having stress or anxiety, 81% were disappointed or sad, 80% said they felt lonely or isolated, 56% had relocated as a result of the pandemic, and 48% reported financial setbacks tied to COVID-19.
“Anxiety seems to have become a feature of modern life,” said Dr. Rostain, who is director of education at the department of psychiatry and professor of psychiatry at the Hospital of the University of Pennsylvania in Philadelphia.
“Our culture, which often has a prominent emotional tone of fear, tends to promote cognitive distortions in which everyone is perceiving danger at every turn.” in this group, he noted. While people should be washing their hands and staying safe through social distancing during the pandemic, “we don’t want people to stop functioning, planning the future, and really in college students’ case, studying and getting ready for their careers,” he said. Parents can hinder those goals through intensively parenting or “overparenting” their children, which can result in destructive perfectionism, anxiety and depression, abject fear of failure and risk avoidance, and a focus on the external aspects of life rather than internal feelings.
Heavier alcohol use and amphetamine use also is on the rise in college students, Dr. Rostain said. Increased stimulant use in young adults is attributed to greater access to prescription drugs prior to college, greater prevalence of attention-deficit/hyperactivity disorder (ADHD), peer pressure, and influence from marketing and media messaging, he said. Another important change is the rise of smartphones and the Internet, which might drive the need to be constantly connected and compete for attention.
“This is the first generation who had constant access to the Internet. Smartphones in particular are everywhere, and we think this is another important factor in considering what might be happening to young people,” Dr. Rostain said.
Developing problem-solving and conflict resolution skills, developing coping mechanisms, being able to regulate emotions, finding optimism toward the future, having access to mental health services, and having cultural or religious beliefs with a negative view of suicide are all protective factors that promote resiliency in young people, Dr. Rostain said. Other protective factors include the development of socio-emotional readiness skills, such as conscientiousness, self-management, interpersonal skills, self-control, task persistence, risk management, self-acceptance, and having an open mindset or seeking help when needed. However, he noted, family is one area that can be both a help or a risk to mental health.
“Family attachments and supportive relationships in the family are really critical in predicting good outcomes. By the same token, families that are conflicted, where there’s a lot of stress or there’s a lot of turmoil and/or where resources are not available, that may be a risk factor to coping in young adulthood,” he said.
Individual resilience can be developed through learning from mistakes and overcoming mindset barriers, such as feelings of not belonging, concerns about disappointing one’s parents, worries about not making it, or fears of being different.
On campus, best practices and emerging trends include wellness and resiliency programs, reducing stigma, engagement from students, training of faculty and staff, crisis management plans, telehealth counseling, substance abuse programs, postvention support after suicide, collaboration with mental health providers, and support for diverse populations.
“The best schools are the ones that promote communication and that invite families to be involved early on because parents and families can be and need to be educated about what to do to prevent adverse outcomes of young people who are really at risk,” Dr. Rostain said. “It takes a village to raise a child, and it takes the same village to bring someone from adolescence to young adulthood.”
Family-based intervention has also shown promise, he said, but clinicians should watch for signs that a family is not willing to undergo therapy, is scapegoating a college student, or there are signs of boundary violations, violence, or sexual abuse in the family – or attempts to undermine treatment.
Specific to COVID-19, campus mental health services should focus on routine, self-care, physical activity, and connections with other people while also space for grieving lost experiences, facing uncertainty, developing resilience, and finding meaning. In the family, challenges around COVID-19 can include issues of physical distancing and quarantine, anxiety about becoming infected with the virus, economic insecurity, managing conflicts, setting and enforcing boundaries in addition to providing mutual support, and finding new meaning during the pandemic.
“I think these are the challenges, but we think this whole process of people living together and handling life in a way they’ve never expected to may hold some silver linings,” Dr. Rostain said. “It may be a way of addressing many issues that were never addressed before the young person went off to college.”
Global Academy and this news organization are owned by the same parent company. Dr. Rostain reported receiving royalties from Routledge/Taylor Francis Group and St. Martin’s Press, scientific advisory board honoraria from Arbor and Shire/Takeda, consulting fees from the National Football League and Tris Pharmaceuticals, and has presented CME sessions for American Psychiatric Publishing, Global Medical Education, Shire/Takeda, and the U.S. Psychiatric Congress.
Socioeconomic, technological, cultural, and historical conditions are contributing to a mental health crisis among college students in the United States, according to Anthony L. Rostain, MD, MA, in a virtual meeting presented by Current Psychiatry and the American Academy of Clinical Psychiatrists.
A recent National College Health Assessment published in fall of 2018 by the American College Health Association found that one in four college students had some kind of diagnosable mental illness, and 44% had symptoms of depression within the past year.
The assessment also found that college students felt overwhelmed (86%), felt sad (68%), felt very lonely (63%), had overwhelming anxiety (62%), experienced feelings of hopelessness (53%), or were depressed to the point where functioning was difficult (41%), all of which was higher than in previous years. Students also were more likely than in previous years to engage in interpersonal violence (17%), seriously consider suicide (11%), intentionally hurt themselves (7.4%), and attempt suicide (1.9%). According to the organization Active Minds, suicide is a leading cause of death in college students.
This shift in mental health for individuals in Generation Z, those born between the mid-1990s and early 2010s, can be attributed to historical events since the turn of the century, Dr. Rostain said at the meeting, presented by Global Academy for Medical Education. The Sept. 11, 2001, attacks, wars in Iraq and Afghanistan, the financial crisis of 2007-2008, school shootings, globalization leading to economic uncertainty, the 24-hour news cycle and continuous media exposure, and the influence of the Internet have all influenced Gen Z’s identity.
“Growing up immersed in the Internet certainly has its advantages, but also maybe created some vulnerabilities in our young people,” he said.
Concerns about climate change, the burden of higher education and student debt, and the COVID-19 pandemic also have contributed to anxiety in this group. In a spring survey of students published by Active Minds about COVID-19 and its impact on mental health, 91% of students reported having stress or anxiety, 81% were disappointed or sad, 80% said they felt lonely or isolated, 56% had relocated as a result of the pandemic, and 48% reported financial setbacks tied to COVID-19.
“Anxiety seems to have become a feature of modern life,” said Dr. Rostain, who is director of education at the department of psychiatry and professor of psychiatry at the Hospital of the University of Pennsylvania in Philadelphia.
“Our culture, which often has a prominent emotional tone of fear, tends to promote cognitive distortions in which everyone is perceiving danger at every turn.” in this group, he noted. While people should be washing their hands and staying safe through social distancing during the pandemic, “we don’t want people to stop functioning, planning the future, and really in college students’ case, studying and getting ready for their careers,” he said. Parents can hinder those goals through intensively parenting or “overparenting” their children, which can result in destructive perfectionism, anxiety and depression, abject fear of failure and risk avoidance, and a focus on the external aspects of life rather than internal feelings.
Heavier alcohol use and amphetamine use also is on the rise in college students, Dr. Rostain said. Increased stimulant use in young adults is attributed to greater access to prescription drugs prior to college, greater prevalence of attention-deficit/hyperactivity disorder (ADHD), peer pressure, and influence from marketing and media messaging, he said. Another important change is the rise of smartphones and the Internet, which might drive the need to be constantly connected and compete for attention.
“This is the first generation who had constant access to the Internet. Smartphones in particular are everywhere, and we think this is another important factor in considering what might be happening to young people,” Dr. Rostain said.
Developing problem-solving and conflict resolution skills, developing coping mechanisms, being able to regulate emotions, finding optimism toward the future, having access to mental health services, and having cultural or religious beliefs with a negative view of suicide are all protective factors that promote resiliency in young people, Dr. Rostain said. Other protective factors include the development of socio-emotional readiness skills, such as conscientiousness, self-management, interpersonal skills, self-control, task persistence, risk management, self-acceptance, and having an open mindset or seeking help when needed. However, he noted, family is one area that can be both a help or a risk to mental health.
“Family attachments and supportive relationships in the family are really critical in predicting good outcomes. By the same token, families that are conflicted, where there’s a lot of stress or there’s a lot of turmoil and/or where resources are not available, that may be a risk factor to coping in young adulthood,” he said.
Individual resilience can be developed through learning from mistakes and overcoming mindset barriers, such as feelings of not belonging, concerns about disappointing one’s parents, worries about not making it, or fears of being different.
On campus, best practices and emerging trends include wellness and resiliency programs, reducing stigma, engagement from students, training of faculty and staff, crisis management plans, telehealth counseling, substance abuse programs, postvention support after suicide, collaboration with mental health providers, and support for diverse populations.
“The best schools are the ones that promote communication and that invite families to be involved early on because parents and families can be and need to be educated about what to do to prevent adverse outcomes of young people who are really at risk,” Dr. Rostain said. “It takes a village to raise a child, and it takes the same village to bring someone from adolescence to young adulthood.”
Family-based intervention has also shown promise, he said, but clinicians should watch for signs that a family is not willing to undergo therapy, is scapegoating a college student, or there are signs of boundary violations, violence, or sexual abuse in the family – or attempts to undermine treatment.
Specific to COVID-19, campus mental health services should focus on routine, self-care, physical activity, and connections with other people while also space for grieving lost experiences, facing uncertainty, developing resilience, and finding meaning. In the family, challenges around COVID-19 can include issues of physical distancing and quarantine, anxiety about becoming infected with the virus, economic insecurity, managing conflicts, setting and enforcing boundaries in addition to providing mutual support, and finding new meaning during the pandemic.
“I think these are the challenges, but we think this whole process of people living together and handling life in a way they’ve never expected to may hold some silver linings,” Dr. Rostain said. “It may be a way of addressing many issues that were never addressed before the young person went off to college.”
Global Academy and this news organization are owned by the same parent company. Dr. Rostain reported receiving royalties from Routledge/Taylor Francis Group and St. Martin’s Press, scientific advisory board honoraria from Arbor and Shire/Takeda, consulting fees from the National Football League and Tris Pharmaceuticals, and has presented CME sessions for American Psychiatric Publishing, Global Medical Education, Shire/Takeda, and the U.S. Psychiatric Congress.
EXPERT ANALYSIS FROM CP/AACP 2020 PSYCHIATRY UPDATE
Acute EVALI remains a diagnosis of exclusion
according to a synthesis of current information presented at the virtual Pediatric Hospital Medicine.
Respiratory symptoms, including cough, chest pain, and shortness of breath are common but so are constitutive symptoms, including fever, sore throat, muscle aches, nausea and vomiting, said Yamini Kuchipudi, MD, a staff physician at Cincinnati Children’s Hospital, during the session at the virtual meeting, sponsored by the Society of Hospital Medicine, the American Academy of Pediatrics, and the Academic Pediatric Association.
If EVALI is not considered across this broad array of symptoms, of which respiratory complaints might not be the most prominent at the time of presentation, the diagnosis might be delayed, Dr. Kuchipudi warned during the virtual meeting.
Teenagers and young adults are the most common users of e-cigarettes and vaping devices. In these patients or in any individual suspected of having EVALI, Dr. Kuchipudi recommended posing questions about vaping relatively early in the work-up “in a confidential and nonjudgmental way.”
Eliciting a truthful history will be particularly important, because the risk of EVALI appears to be largely related to vaping with tetrahydrocannabinol (THC)-containing products rather than with nicotine alone. Although the exact cause of EVALI is not yet completely clear, this condition is now strongly associated with additives to the THC, according to Issa Hanna, MD, of the department of pediatrics at the University of Florida, Jacksonville.
“E-liquid contains products like hydrocarbons, vitamin E acetate, and heavy metals that appear to damage the alveolar epithelium by direct cellular inflammation,” Dr. Hanna explained.
These products are not only found in THC processed for vaping but also for dabbing, a related but different form of inhalation that involves vaporization of highly concentrated THC waxes or resins. Dr. Hanna suggested that the decline in reported cases of EVALI, which has followed the peak incidence in September 2019, is likely to be related to a decline in THC additives as well as greater caution among users.
E-cigarettes were introduced in 2007, according to Dr. Hanna, but EVALI was not widely recognized until cases began accruing early in 2019. By June 2019, the growing number of case reports had attracted the attention of the media as well as public health officials, intensifying the effort to isolate the risks and causes.
Consistent with greater use of e-cigarettes and vaping among younger individuals, nearly 80% of the 2,807 patients hospitalized for EVALI in the United States by February of this year occurred in individuals aged less than 35 years, according to data released by the Centers for Disease Control and Prevention. The median age was less than 25 years. Of these hospitalizations, 68 deaths (2.5%) in 29 states and Washington, D.C., were attributed to EVALI.
Because of the nonspecific symptoms and lack of a definitive diagnostic test, EVALI is considered a diagnosis of exclusion, according to Abigail Musial, MD, who is completing a fellowship in hospital medicine at Cincinnati Children’s. She presented a case in which a patient suspected of EVALI went home after symptoms abated on steroids.
“Less than 24 hours later, she returned to the ED with tachypnea and hypoxemia,” Dr. Musial recounted. Although a chest x-ray at the initial evaluation showed lung opacities, a repeat chest x-ray when she returned to the ED showed bilateral worsening of these opacities and persistent elevation of inflammatory markers.
“She was started on steroids and also on antibiotics,” Dr. Musial said. “She was weaned quickly from oxygen once the steroids were started and was discharged on hospital day 3.”
For patients suspected of EVALI, COVID-19 testing should be part of the work-up, according to Dr. Kuchipudi. She also recommended an x-ray or CT scan of the lung as well as an evaluation of inflammatory markers.
Dr. Kuchipudi said that more invasive studies than lung function tests, such as bronchoalveolar lavage or lung biopsy, might be considered when severe symptoms make aggressive diagnostic studies attractive.
Steroids and antibiotics typically lead to control of acute symptoms, but patients should be clinically stable for 24-48 hours prior to hospital discharge, according to Dr. Kuchipudi. Follow-up after discharge should include lung function tests and imaging 2-4 weeks later to confirm resolution of abnormalities.
Dr. Kuchipudi stressed the opportunity that an episode of EVALI provides to induce patients to give up nicotine and vaping entirely. Such strategies, such as a nicotine patch, deserve consideration, but she also cautioned that e-cigarettes for smoking cessation should not be recommended to EVALI patients.
The speakers reported no potential conflicts of interest relevant to this study.
according to a synthesis of current information presented at the virtual Pediatric Hospital Medicine.
Respiratory symptoms, including cough, chest pain, and shortness of breath are common but so are constitutive symptoms, including fever, sore throat, muscle aches, nausea and vomiting, said Yamini Kuchipudi, MD, a staff physician at Cincinnati Children’s Hospital, during the session at the virtual meeting, sponsored by the Society of Hospital Medicine, the American Academy of Pediatrics, and the Academic Pediatric Association.
If EVALI is not considered across this broad array of symptoms, of which respiratory complaints might not be the most prominent at the time of presentation, the diagnosis might be delayed, Dr. Kuchipudi warned during the virtual meeting.
Teenagers and young adults are the most common users of e-cigarettes and vaping devices. In these patients or in any individual suspected of having EVALI, Dr. Kuchipudi recommended posing questions about vaping relatively early in the work-up “in a confidential and nonjudgmental way.”
Eliciting a truthful history will be particularly important, because the risk of EVALI appears to be largely related to vaping with tetrahydrocannabinol (THC)-containing products rather than with nicotine alone. Although the exact cause of EVALI is not yet completely clear, this condition is now strongly associated with additives to the THC, according to Issa Hanna, MD, of the department of pediatrics at the University of Florida, Jacksonville.
“E-liquid contains products like hydrocarbons, vitamin E acetate, and heavy metals that appear to damage the alveolar epithelium by direct cellular inflammation,” Dr. Hanna explained.
These products are not only found in THC processed for vaping but also for dabbing, a related but different form of inhalation that involves vaporization of highly concentrated THC waxes or resins. Dr. Hanna suggested that the decline in reported cases of EVALI, which has followed the peak incidence in September 2019, is likely to be related to a decline in THC additives as well as greater caution among users.
E-cigarettes were introduced in 2007, according to Dr. Hanna, but EVALI was not widely recognized until cases began accruing early in 2019. By June 2019, the growing number of case reports had attracted the attention of the media as well as public health officials, intensifying the effort to isolate the risks and causes.
Consistent with greater use of e-cigarettes and vaping among younger individuals, nearly 80% of the 2,807 patients hospitalized for EVALI in the United States by February of this year occurred in individuals aged less than 35 years, according to data released by the Centers for Disease Control and Prevention. The median age was less than 25 years. Of these hospitalizations, 68 deaths (2.5%) in 29 states and Washington, D.C., were attributed to EVALI.
Because of the nonspecific symptoms and lack of a definitive diagnostic test, EVALI is considered a diagnosis of exclusion, according to Abigail Musial, MD, who is completing a fellowship in hospital medicine at Cincinnati Children’s. She presented a case in which a patient suspected of EVALI went home after symptoms abated on steroids.
“Less than 24 hours later, she returned to the ED with tachypnea and hypoxemia,” Dr. Musial recounted. Although a chest x-ray at the initial evaluation showed lung opacities, a repeat chest x-ray when she returned to the ED showed bilateral worsening of these opacities and persistent elevation of inflammatory markers.
“She was started on steroids and also on antibiotics,” Dr. Musial said. “She was weaned quickly from oxygen once the steroids were started and was discharged on hospital day 3.”
For patients suspected of EVALI, COVID-19 testing should be part of the work-up, according to Dr. Kuchipudi. She also recommended an x-ray or CT scan of the lung as well as an evaluation of inflammatory markers.
Dr. Kuchipudi said that more invasive studies than lung function tests, such as bronchoalveolar lavage or lung biopsy, might be considered when severe symptoms make aggressive diagnostic studies attractive.
Steroids and antibiotics typically lead to control of acute symptoms, but patients should be clinically stable for 24-48 hours prior to hospital discharge, according to Dr. Kuchipudi. Follow-up after discharge should include lung function tests and imaging 2-4 weeks later to confirm resolution of abnormalities.
Dr. Kuchipudi stressed the opportunity that an episode of EVALI provides to induce patients to give up nicotine and vaping entirely. Such strategies, such as a nicotine patch, deserve consideration, but she also cautioned that e-cigarettes for smoking cessation should not be recommended to EVALI patients.
The speakers reported no potential conflicts of interest relevant to this study.
according to a synthesis of current information presented at the virtual Pediatric Hospital Medicine.
Respiratory symptoms, including cough, chest pain, and shortness of breath are common but so are constitutive symptoms, including fever, sore throat, muscle aches, nausea and vomiting, said Yamini Kuchipudi, MD, a staff physician at Cincinnati Children’s Hospital, during the session at the virtual meeting, sponsored by the Society of Hospital Medicine, the American Academy of Pediatrics, and the Academic Pediatric Association.
If EVALI is not considered across this broad array of symptoms, of which respiratory complaints might not be the most prominent at the time of presentation, the diagnosis might be delayed, Dr. Kuchipudi warned during the virtual meeting.
Teenagers and young adults are the most common users of e-cigarettes and vaping devices. In these patients or in any individual suspected of having EVALI, Dr. Kuchipudi recommended posing questions about vaping relatively early in the work-up “in a confidential and nonjudgmental way.”
Eliciting a truthful history will be particularly important, because the risk of EVALI appears to be largely related to vaping with tetrahydrocannabinol (THC)-containing products rather than with nicotine alone. Although the exact cause of EVALI is not yet completely clear, this condition is now strongly associated with additives to the THC, according to Issa Hanna, MD, of the department of pediatrics at the University of Florida, Jacksonville.
“E-liquid contains products like hydrocarbons, vitamin E acetate, and heavy metals that appear to damage the alveolar epithelium by direct cellular inflammation,” Dr. Hanna explained.
These products are not only found in THC processed for vaping but also for dabbing, a related but different form of inhalation that involves vaporization of highly concentrated THC waxes or resins. Dr. Hanna suggested that the decline in reported cases of EVALI, which has followed the peak incidence in September 2019, is likely to be related to a decline in THC additives as well as greater caution among users.
E-cigarettes were introduced in 2007, according to Dr. Hanna, but EVALI was not widely recognized until cases began accruing early in 2019. By June 2019, the growing number of case reports had attracted the attention of the media as well as public health officials, intensifying the effort to isolate the risks and causes.
Consistent with greater use of e-cigarettes and vaping among younger individuals, nearly 80% of the 2,807 patients hospitalized for EVALI in the United States by February of this year occurred in individuals aged less than 35 years, according to data released by the Centers for Disease Control and Prevention. The median age was less than 25 years. Of these hospitalizations, 68 deaths (2.5%) in 29 states and Washington, D.C., were attributed to EVALI.
Because of the nonspecific symptoms and lack of a definitive diagnostic test, EVALI is considered a diagnosis of exclusion, according to Abigail Musial, MD, who is completing a fellowship in hospital medicine at Cincinnati Children’s. She presented a case in which a patient suspected of EVALI went home after symptoms abated on steroids.
“Less than 24 hours later, she returned to the ED with tachypnea and hypoxemia,” Dr. Musial recounted. Although a chest x-ray at the initial evaluation showed lung opacities, a repeat chest x-ray when she returned to the ED showed bilateral worsening of these opacities and persistent elevation of inflammatory markers.
“She was started on steroids and also on antibiotics,” Dr. Musial said. “She was weaned quickly from oxygen once the steroids were started and was discharged on hospital day 3.”
For patients suspected of EVALI, COVID-19 testing should be part of the work-up, according to Dr. Kuchipudi. She also recommended an x-ray or CT scan of the lung as well as an evaluation of inflammatory markers.
Dr. Kuchipudi said that more invasive studies than lung function tests, such as bronchoalveolar lavage or lung biopsy, might be considered when severe symptoms make aggressive diagnostic studies attractive.
Steroids and antibiotics typically lead to control of acute symptoms, but patients should be clinically stable for 24-48 hours prior to hospital discharge, according to Dr. Kuchipudi. Follow-up after discharge should include lung function tests and imaging 2-4 weeks later to confirm resolution of abnormalities.
Dr. Kuchipudi stressed the opportunity that an episode of EVALI provides to induce patients to give up nicotine and vaping entirely. Such strategies, such as a nicotine patch, deserve consideration, but she also cautioned that e-cigarettes for smoking cessation should not be recommended to EVALI patients.
The speakers reported no potential conflicts of interest relevant to this study.
FROM PHM20