MDedge Dermatology

As dermatology residents, we have a lot on our plates. With so many diagnoses to learn and treatments to understand, the sheer volume of knowledge we are expected to be familiar with sometimes can be overwhelming. The thought of adding yet another thing to the list of many things we already need to know—least of all a topic such as dermatoethics—may be unappealing. This article will discuss the importance of ethics training in dermatology residency as well as provide helpful resources for how this training can be achieved.

Professionalism as a Core Competency

The Accreditation Council for Graduate Medical Education (ACGME) considers professionalism as 1 of its 6 core competencies.¹ These competencies provide a conceptual framework detailing the domains physicians should be proficient in before they can enter autonomous practice. When it comes to professionalism, residents are expected to demonstrate compassion, integrity, and respect for others; honesty with patients; respect for patient confidentiality and autonomy; appropriate relationships with patients; accountability to patients, society, and the profession; and a sensitivity and responsiveness to diverse patient population.¹

The ACGME milestones are intended to assess resident development within the 6 competencies with more specific parameters for evaluation.² Those pertaining to professionalism evaluate a resident’s ability to demonstrate professional behavior, an understanding of ethical principles, accountability, and conscientiousness, as well as self-awareness and the ability to seek help for personal or professional well-being. The crux of the kinds of activities that constitute acquisition of these professional skills are specialty specific. The ACGME ultimately believes that having a working knowledge of professionalism and ethical principles prepares residents for practicing medicine in the real world. Because of these requirements, residency programs are expected to provide resources for residents to explore ethical problems faced by dermatologists.

Beyond “Passing” Residency

The reality is that learning about medical ethics and practicing professional behavior is not just about ticking boxes to get ACGME accreditation or to “pass” residency. The data suggest that having a strong foundation in these principles is good for overall personal well-being, job satisfaction, and patient care. Studies have shown that unprofessional behavior in medical school is correlated to disciplinary action by state licensing boards against practicing physicians.^3,4 In fact, a study found that in one cohort of physicians (N=68), 95% of disciplinary actions were for lapses in professionalism, which included activities such as sexual misconduct and inappropriate prescribing.⁴ Behaving appropriately protects your license to practice medicine.

Thinking through these problematic ethical scenarios also goes beyond coming up with the right answer. Exploring ethical conundrums is thought to develop analytical skills that can help one navigate future tricky situations that can be morally distressing and can lead to burnout. Introspection and self-awareness coupled with these skills ideally will help physicians think through sensitive and difficult situations with the courage to hold true to their convictions and ultimately uphold the professionalism of the specialty.⁵

Self-awareness has the additional bonus of empowering physicians to acknowledge personal and professional limitations with the goal of seeking help when it is needed before it is too late. It comes as no surprise that how we feel as physicians directly impacts how we treat our patients. One study found that depressed residents were more than 6 times more likely to make medication errors compared to nondepressed colleagues.⁶ Regularly taking stock of our professional and personal reserves can go a long way to improving overall well-being.

Resources for Dermatoethics Training

The best starting point for developing a robust dermatoethics curriculum is the material provided by the American Board of Dermatology, which is available online.⁷ An ad hoc subcommittee of the American Board of Dermatology composed of experts in dermatoethics and resident education reviewed relevant ethics literature and identified 6 core domains considered fundamental to dermatology resident education in ethics and professionalism.⁸ This team also provided a thorough list of relevant background readings for each topic. To cover pertinent material, the subcommittee recommended a 60-minute teaching session every other month with the intent of covering all the material over a 3-year period. If your program directors are not aware of this great resource and you feel your own ethics training may be lacking, bringing this up as a template might be helpful. A detailed description of an innovative dermatoethics curriculum organized at the Department of Dermatology at the Warren Alpert Medical School of Brown University (Providence, Rhode Island) in 2001 also may serve as a guide for programs hoping to design their own approach.⁵

For those interested in self-study, there is an excellent text dedicated to dermatoethics, which is aptly entitled Dermatoethics: Contemporary Ethics and Professionalism in Dermatology.⁹ This book offers superb case-based discussions on a wide range of ethical quandaries that dermatologists may face, ranging from unsolicited dermatologic advice (eg, Is it wrong to tell the person next to you in the grocery store that they might have a melanoma?) to research and publication ethics. This text provides a toolkit for handling tough situations in the clinic and beyond. The Journal of the American Academy of Dermatology publishes an Ethics Journal Club for which contributors can submit real-life practical ethical dilemmas, and the journal solicits a resolution or response from a dermatoethicist.

Additionally, a pilot curriculum project out of the University of Utah (Salt Lake City, Utah), of which I am a team member, currently is designing and testing several dermatoethics PowerPoint modules with the intention of making this material widely available through medical education portals.

The Hidden Curriculum

A formal curriculum can only provide so much when it comes to ethics training. In truth, much of what we learn as ethically minded dermatologists comes from our day-to-day practice.¹⁰ Paying attention to the more informal curriculum that we are immersed in during routine as well as unusual encounters also is important for achieving milestones. Teaching moments for thinking through ethical dilemmas abound, and this approach easily can be incorporated into routine workflow.¹¹ Next time you encounter an ethical situation that gives you pause (eg, Can I biopsy an intubated patient without getting appropriate consent?), talk it through with your supervisor. Gems of autonomous practice often can be mined from these off-the-cuff conversations.

Can Professionalism Be Taught?

Finally, it is worth mentioning that while the number of resources available to dermatology residents for honing their ethics skills is increasing, ways of measuring the impact of this additional training in vivo are not.¹² There are no good tools available to determine how ethics training influences resident behaviors. Similarly, there is no good evidence for what constitutes the most effective method for teaching medical ethics to trainees. It is a growing field with lots of room for more robust research. For now, the overall goal of a dermatoethics curriculum is to provide a mix of curriculum opportunities, ranging from formal lectures and readings to more informal conversations, with the hope of providing residents a toolbox for dealing with ethical dilemmas and a working knowledge of professionalism.

Final Thoughts

There are several resources available for dermatology programs to provide quality dermatoethics training to their residents. These can be mixed and matched to create a tailored formal curriculum alongside the more informal ethics training that happens in the clinic and on the wards. Providing this education is about more than just fulfilling accreditation requirements. Understanding ethical principles and how they can be applied to navigate sensitive situations is ultimately good for both professional and personal well-being.

As dermatology residents, we have a lot on our plates. With so many diagnoses to learn and treatments to understand, the sheer volume of knowledge we are expected to be familiar with sometimes can be overwhelming. The thought of adding yet another thing to the list of many things we already need to know—least of all a topic such as dermatoethics—may be unappealing. This article will discuss the importance of ethics training in dermatology residency as well as provide helpful resources for how this training can be achieved.

Professionalism as a Core Competency

The Accreditation Council for Graduate Medical Education (ACGME) considers professionalism as 1 of its 6 core competencies.¹ These competencies provide a conceptual framework detailing the domains physicians should be proficient in before they can enter autonomous practice. When it comes to professionalism, residents are expected to demonstrate compassion, integrity, and respect for others; honesty with patients; respect for patient confidentiality and autonomy; appropriate relationships with patients; accountability to patients, society, and the profession; and a sensitivity and responsiveness to diverse patient population.¹

The ACGME milestones are intended to assess resident development within the 6 competencies with more specific parameters for evaluation.² Those pertaining to professionalism evaluate a resident’s ability to demonstrate professional behavior, an understanding of ethical principles, accountability, and conscientiousness, as well as self-awareness and the ability to seek help for personal or professional well-being. The crux of the kinds of activities that constitute acquisition of these professional skills are specialty specific. The ACGME ultimately believes that having a working knowledge of professionalism and ethical principles prepares residents for practicing medicine in the real world. Because of these requirements, residency programs are expected to provide resources for residents to explore ethical problems faced by dermatologists.

Beyond “Passing” Residency

The reality is that learning about medical ethics and practicing professional behavior is not just about ticking boxes to get ACGME accreditation or to “pass” residency. The data suggest that having a strong foundation in these principles is good for overall personal well-being, job satisfaction, and patient care. Studies have shown that unprofessional behavior in medical school is correlated to disciplinary action by state licensing boards against practicing physicians.^3,4 In fact, a study found that in one cohort of physicians (N=68), 95% of disciplinary actions were for lapses in professionalism, which included activities such as sexual misconduct and inappropriate prescribing.⁴ Behaving appropriately protects your license to practice medicine.

Thinking through these problematic ethical scenarios also goes beyond coming up with the right answer. Exploring ethical conundrums is thought to develop analytical skills that can help one navigate future tricky situations that can be morally distressing and can lead to burnout. Introspection and self-awareness coupled with these skills ideally will help physicians think through sensitive and difficult situations with the courage to hold true to their convictions and ultimately uphold the professionalism of the specialty.⁵

Self-awareness has the additional bonus of empowering physicians to acknowledge personal and professional limitations with the goal of seeking help when it is needed before it is too late. It comes as no surprise that how we feel as physicians directly impacts how we treat our patients. One study found that depressed residents were more than 6 times more likely to make medication errors compared to nondepressed colleagues.⁶ Regularly taking stock of our professional and personal reserves can go a long way to improving overall well-being.

Resources for Dermatoethics Training

The best starting point for developing a robust dermatoethics curriculum is the material provided by the American Board of Dermatology, which is available online.⁷ An ad hoc subcommittee of the American Board of Dermatology composed of experts in dermatoethics and resident education reviewed relevant ethics literature and identified 6 core domains considered fundamental to dermatology resident education in ethics and professionalism.⁸ This team also provided a thorough list of relevant background readings for each topic. To cover pertinent material, the subcommittee recommended a 60-minute teaching session every other month with the intent of covering all the material over a 3-year period. If your program directors are not aware of this great resource and you feel your own ethics training may be lacking, bringing this up as a template might be helpful. A detailed description of an innovative dermatoethics curriculum organized at the Department of Dermatology at the Warren Alpert Medical School of Brown University (Providence, Rhode Island) in 2001 also may serve as a guide for programs hoping to design their own approach.⁵

For those interested in self-study, there is an excellent text dedicated to dermatoethics, which is aptly entitled Dermatoethics: Contemporary Ethics and Professionalism in Dermatology.⁹ This book offers superb case-based discussions on a wide range of ethical quandaries that dermatologists may face, ranging from unsolicited dermatologic advice (eg, Is it wrong to tell the person next to you in the grocery store that they might have a melanoma?) to research and publication ethics. This text provides a toolkit for handling tough situations in the clinic and beyond. The Journal of the American Academy of Dermatology publishes an Ethics Journal Club for which contributors can submit real-life practical ethical dilemmas, and the journal solicits a resolution or response from a dermatoethicist.

Additionally, a pilot curriculum project out of the University of Utah (Salt Lake City, Utah), of which I am a team member, currently is designing and testing several dermatoethics PowerPoint modules with the intention of making this material widely available through medical education portals.

The Hidden Curriculum

A formal curriculum can only provide so much when it comes to ethics training. In truth, much of what we learn as ethically minded dermatologists comes from our day-to-day practice.¹⁰ Paying attention to the more informal curriculum that we are immersed in during routine as well as unusual encounters also is important for achieving milestones. Teaching moments for thinking through ethical dilemmas abound, and this approach easily can be incorporated into routine workflow.¹¹ Next time you encounter an ethical situation that gives you pause (eg, Can I biopsy an intubated patient without getting appropriate consent?), talk it through with your supervisor. Gems of autonomous practice often can be mined from these off-the-cuff conversations.

Can Professionalism Be Taught?

Finally, it is worth mentioning that while the number of resources available to dermatology residents for honing their ethics skills is increasing, ways of measuring the impact of this additional training in vivo are not.¹² There are no good tools available to determine how ethics training influences resident behaviors. Similarly, there is no good evidence for what constitutes the most effective method for teaching medical ethics to trainees. It is a growing field with lots of room for more robust research. For now, the overall goal of a dermatoethics curriculum is to provide a mix of curriculum opportunities, ranging from formal lectures and readings to more informal conversations, with the hope of providing residents a toolbox for dealing with ethical dilemmas and a working knowledge of professionalism.

Final Thoughts

There are several resources available for dermatology programs to provide quality dermatoethics training to their residents. These can be mixed and matched to create a tailored formal curriculum alongside the more informal ethics training that happens in the clinic and on the wards. Providing this education is about more than just fulfilling accreditation requirements. Understanding ethical principles and how they can be applied to navigate sensitive situations is ultimately good for both professional and personal well-being.

As dermatology residents, we have a lot on our plates. With so many diagnoses to learn and treatments to understand, the sheer volume of knowledge we are expected to be familiar with sometimes can be overwhelming. The thought of adding yet another thing to the list of many things we already need to know—least of all a topic such as dermatoethics—may be unappealing. This article will discuss the importance of ethics training in dermatology residency as well as provide helpful resources for how this training can be achieved.

Professionalism as a Core Competency

The Accreditation Council for Graduate Medical Education (ACGME) considers professionalism as 1 of its 6 core competencies.¹ These competencies provide a conceptual framework detailing the domains physicians should be proficient in before they can enter autonomous practice. When it comes to professionalism, residents are expected to demonstrate compassion, integrity, and respect for others; honesty with patients; respect for patient confidentiality and autonomy; appropriate relationships with patients; accountability to patients, society, and the profession; and a sensitivity and responsiveness to diverse patient population.¹

The ACGME milestones are intended to assess resident development within the 6 competencies with more specific parameters for evaluation.² Those pertaining to professionalism evaluate a resident’s ability to demonstrate professional behavior, an understanding of ethical principles, accountability, and conscientiousness, as well as self-awareness and the ability to seek help for personal or professional well-being. The crux of the kinds of activities that constitute acquisition of these professional skills are specialty specific. The ACGME ultimately believes that having a working knowledge of professionalism and ethical principles prepares residents for practicing medicine in the real world. Because of these requirements, residency programs are expected to provide resources for residents to explore ethical problems faced by dermatologists.

Beyond “Passing” Residency

The reality is that learning about medical ethics and practicing professional behavior is not just about ticking boxes to get ACGME accreditation or to “pass” residency. The data suggest that having a strong foundation in these principles is good for overall personal well-being, job satisfaction, and patient care. Studies have shown that unprofessional behavior in medical school is correlated to disciplinary action by state licensing boards against practicing physicians.^3,4 In fact, a study found that in one cohort of physicians (N=68), 95% of disciplinary actions were for lapses in professionalism, which included activities such as sexual misconduct and inappropriate prescribing.⁴ Behaving appropriately protects your license to practice medicine.

Thinking through these problematic ethical scenarios also goes beyond coming up with the right answer. Exploring ethical conundrums is thought to develop analytical skills that can help one navigate future tricky situations that can be morally distressing and can lead to burnout. Introspection and self-awareness coupled with these skills ideally will help physicians think through sensitive and difficult situations with the courage to hold true to their convictions and ultimately uphold the professionalism of the specialty.⁵

Self-awareness has the additional bonus of empowering physicians to acknowledge personal and professional limitations with the goal of seeking help when it is needed before it is too late. It comes as no surprise that how we feel as physicians directly impacts how we treat our patients. One study found that depressed residents were more than 6 times more likely to make medication errors compared to nondepressed colleagues.⁶ Regularly taking stock of our professional and personal reserves can go a long way to improving overall well-being.

Resources for Dermatoethics Training

The best starting point for developing a robust dermatoethics curriculum is the material provided by the American Board of Dermatology, which is available online.⁷ An ad hoc subcommittee of the American Board of Dermatology composed of experts in dermatoethics and resident education reviewed relevant ethics literature and identified 6 core domains considered fundamental to dermatology resident education in ethics and professionalism.⁸ This team also provided a thorough list of relevant background readings for each topic. To cover pertinent material, the subcommittee recommended a 60-minute teaching session every other month with the intent of covering all the material over a 3-year period. If your program directors are not aware of this great resource and you feel your own ethics training may be lacking, bringing this up as a template might be helpful. A detailed description of an innovative dermatoethics curriculum organized at the Department of Dermatology at the Warren Alpert Medical School of Brown University (Providence, Rhode Island) in 2001 also may serve as a guide for programs hoping to design their own approach.⁵

For those interested in self-study, there is an excellent text dedicated to dermatoethics, which is aptly entitled Dermatoethics: Contemporary Ethics and Professionalism in Dermatology.⁹ This book offers superb case-based discussions on a wide range of ethical quandaries that dermatologists may face, ranging from unsolicited dermatologic advice (eg, Is it wrong to tell the person next to you in the grocery store that they might have a melanoma?) to research and publication ethics. This text provides a toolkit for handling tough situations in the clinic and beyond. The Journal of the American Academy of Dermatology publishes an Ethics Journal Club for which contributors can submit real-life practical ethical dilemmas, and the journal solicits a resolution or response from a dermatoethicist.

Additionally, a pilot curriculum project out of the University of Utah (Salt Lake City, Utah), of which I am a team member, currently is designing and testing several dermatoethics PowerPoint modules with the intention of making this material widely available through medical education portals.

The Hidden Curriculum

A formal curriculum can only provide so much when it comes to ethics training. In truth, much of what we learn as ethically minded dermatologists comes from our day-to-day practice.¹⁰ Paying attention to the more informal curriculum that we are immersed in during routine as well as unusual encounters also is important for achieving milestones. Teaching moments for thinking through ethical dilemmas abound, and this approach easily can be incorporated into routine workflow.¹¹ Next time you encounter an ethical situation that gives you pause (eg, Can I biopsy an intubated patient without getting appropriate consent?), talk it through with your supervisor. Gems of autonomous practice often can be mined from these off-the-cuff conversations.

Can Professionalism Be Taught?

Finally, it is worth mentioning that while the number of resources available to dermatology residents for honing their ethics skills is increasing, ways of measuring the impact of this additional training in vivo are not.¹² There are no good tools available to determine how ethics training influences resident behaviors. Similarly, there is no good evidence for what constitutes the most effective method for teaching medical ethics to trainees. It is a growing field with lots of room for more robust research. For now, the overall goal of a dermatoethics curriculum is to provide a mix of curriculum opportunities, ranging from formal lectures and readings to more informal conversations, with the hope of providing residents a toolbox for dealing with ethical dilemmas and a working knowledge of professionalism.

Final Thoughts

There are several resources available for dermatology programs to provide quality dermatoethics training to their residents. These can be mixed and matched to create a tailored formal curriculum alongside the more informal ethics training that happens in the clinic and on the wards. Providing this education is about more than just fulfilling accreditation requirements. Understanding ethical principles and how they can be applied to navigate sensitive situations is ultimately good for both professional and personal well-being.

The Diagnosis: Platelike Osteoma Cutis 

Histopathologic examination revealed extensive cutaneous ossification in the dermis and subcutis with dermal fibrosis and minimal surrounding inflammation (Figure 1). There was no evidence of infection or neoplasm. Further evaluation did not demonstrate any additional physical dysmorphia, and there were no imbalances of calcium-phosphate metabolism or abnormalities in parathyroid hormone or thyroid hormone function. A diagnosis of platelike osteoma cutis (PLOC) was favored. Computed tomography of the head showed material at the posterior skull of similar density to the adjacent calvarial skull and centered within the dermis, consistent with osteoma cutis (Figure 2). 

Osteoma cutis describes the formation of bone within the skin. It occurs when hydroxyapatite crystals in a proteinaceous matrix are deposited within the skin, ultimately leading to the formation of bone ultrastructure. Ossification of the skin most often occurs secondary to trauma, inflammation, or neoplasm; however, it rarely may be a primary event.^1,2 

Platelike osteoma cutis is a rare form of primary cutaneous ossification in which bone forms within the skin in a platelike manner. It most frequently affects the scalp but also has been observed on the trunk and extremities.¹ A driving metabolic or endocrine abnormality typically is not identified.² 

Platelike osteoma cutis can occur as an isolated finding or as a feature of Albright hereditary osteodystrophy (AHO) or progressive osseous heteroplasia (POH). In addition to cutaneous ossification, AHO involves short stature, endocrinopathy, obesity, shortened fourth and fifth metacarpals, and mental retardation. Progressive osseous heteroplasia is characterized by progressive ossification of the skin and deeper tissues such as muscle and fascia, leading to severe movement restriction; it is believed to be a localized nonprogressive variant of POH.^3,4 Mutations in the guanine nucleotide binding protein, alpha stimulating activity polypeptide 1 gene, GNAS1, a key regulatory gene involved in AHO and POH, have been found in several cases of PLOC.³ Our patient lacked any dysmorphic features or laboratory abnormalities suggestive of AHO or POH. Moreover, testing of the tissue and blood for the GNAS1 mutation was negative. Treatment of PLOC often is difficult. Our patient underwent a trial of ablative fractional laser resurfacing, which failed to lead to perceivable improvement.  

The differential diagnoses include a kerion, dissecting cellulitis of the scalp, folliculitis decalvans, and acne keloidalis nuchae. A kerion is a manifestation of tinea capitis characterized by an inflammatory plaque, often with pain or tenderness. Kerions most frequently occur in children aged 5 to 10 years.⁵ Failure to treat a kerion may result in scarring alopecia. Treatment consists of oral antifungals.  

Dissecting cellulitis of the scalp is thought to occur secondary to follicular occlusion. It is characterized by boggy suppurative nodules primarily on the posterior and vertex scalp. Patchy hair loss is present and typically progresses to cicatricial alopecia. Histology characteristically shows areas of dense, predominantly neutrophilic, perifollicular dermal infiltrates.⁶ 

Folliculitis decalvans is a primary neutrophilic cicatricial alopecia that primarily occurs in adults. Patients with folliculitis decalvans tend to have multiple pustules on the periphery of confluent areas of scarring alopecia. It is theorized that an immune response to staphylococcal superantigens contributes to this disease process.⁷  

The clinical findings of acne keloidalis nuchae include inflammatory pustules and papules with keloidlike plaques on the posterior neck and scalp. It occurs predominantly in teenaged and adult males of African ancestry.⁸ Treatment is aimed at reducing inflammation and preventing exacerbating factors. Severe disease courses may lead to scarring alopecia.

The Diagnosis: Platelike Osteoma Cutis 

Histopathologic examination revealed extensive cutaneous ossification in the dermis and subcutis with dermal fibrosis and minimal surrounding inflammation (Figure 1). There was no evidence of infection or neoplasm. Further evaluation did not demonstrate any additional physical dysmorphia, and there were no imbalances of calcium-phosphate metabolism or abnormalities in parathyroid hormone or thyroid hormone function. A diagnosis of platelike osteoma cutis (PLOC) was favored. Computed tomography of the head showed material at the posterior skull of similar density to the adjacent calvarial skull and centered within the dermis, consistent with osteoma cutis (Figure 2). 

Osteoma cutis describes the formation of bone within the skin. It occurs when hydroxyapatite crystals in a proteinaceous matrix are deposited within the skin, ultimately leading to the formation of bone ultrastructure. Ossification of the skin most often occurs secondary to trauma, inflammation, or neoplasm; however, it rarely may be a primary event.^1,2 

Platelike osteoma cutis is a rare form of primary cutaneous ossification in which bone forms within the skin in a platelike manner. It most frequently affects the scalp but also has been observed on the trunk and extremities.¹ A driving metabolic or endocrine abnormality typically is not identified.² 

Platelike osteoma cutis can occur as an isolated finding or as a feature of Albright hereditary osteodystrophy (AHO) or progressive osseous heteroplasia (POH). In addition to cutaneous ossification, AHO involves short stature, endocrinopathy, obesity, shortened fourth and fifth metacarpals, and mental retardation. Progressive osseous heteroplasia is characterized by progressive ossification of the skin and deeper tissues such as muscle and fascia, leading to severe movement restriction; it is believed to be a localized nonprogressive variant of POH.^3,4 Mutations in the guanine nucleotide binding protein, alpha stimulating activity polypeptide 1 gene, GNAS1, a key regulatory gene involved in AHO and POH, have been found in several cases of PLOC.³ Our patient lacked any dysmorphic features or laboratory abnormalities suggestive of AHO or POH. Moreover, testing of the tissue and blood for the GNAS1 mutation was negative. Treatment of PLOC often is difficult. Our patient underwent a trial of ablative fractional laser resurfacing, which failed to lead to perceivable improvement.  

The differential diagnoses include a kerion, dissecting cellulitis of the scalp, folliculitis decalvans, and acne keloidalis nuchae. A kerion is a manifestation of tinea capitis characterized by an inflammatory plaque, often with pain or tenderness. Kerions most frequently occur in children aged 5 to 10 years.⁵ Failure to treat a kerion may result in scarring alopecia. Treatment consists of oral antifungals.  

Dissecting cellulitis of the scalp is thought to occur secondary to follicular occlusion. It is characterized by boggy suppurative nodules primarily on the posterior and vertex scalp. Patchy hair loss is present and typically progresses to cicatricial alopecia. Histology characteristically shows areas of dense, predominantly neutrophilic, perifollicular dermal infiltrates.⁶ 

Folliculitis decalvans is a primary neutrophilic cicatricial alopecia that primarily occurs in adults. Patients with folliculitis decalvans tend to have multiple pustules on the periphery of confluent areas of scarring alopecia. It is theorized that an immune response to staphylococcal superantigens contributes to this disease process.⁷  

The clinical findings of acne keloidalis nuchae include inflammatory pustules and papules with keloidlike plaques on the posterior neck and scalp. It occurs predominantly in teenaged and adult males of African ancestry.⁸ Treatment is aimed at reducing inflammation and preventing exacerbating factors. Severe disease courses may lead to scarring alopecia.

The Diagnosis: Platelike Osteoma Cutis 

Histopathologic examination revealed extensive cutaneous ossification in the dermis and subcutis with dermal fibrosis and minimal surrounding inflammation (Figure 1). There was no evidence of infection or neoplasm. Further evaluation did not demonstrate any additional physical dysmorphia, and there were no imbalances of calcium-phosphate metabolism or abnormalities in parathyroid hormone or thyroid hormone function. A diagnosis of platelike osteoma cutis (PLOC) was favored. Computed tomography of the head showed material at the posterior skull of similar density to the adjacent calvarial skull and centered within the dermis, consistent with osteoma cutis (Figure 2). 

Osteoma cutis describes the formation of bone within the skin. It occurs when hydroxyapatite crystals in a proteinaceous matrix are deposited within the skin, ultimately leading to the formation of bone ultrastructure. Ossification of the skin most often occurs secondary to trauma, inflammation, or neoplasm; however, it rarely may be a primary event.^1,2 

Platelike osteoma cutis is a rare form of primary cutaneous ossification in which bone forms within the skin in a platelike manner. It most frequently affects the scalp but also has been observed on the trunk and extremities.¹ A driving metabolic or endocrine abnormality typically is not identified.² 

Platelike osteoma cutis can occur as an isolated finding or as a feature of Albright hereditary osteodystrophy (AHO) or progressive osseous heteroplasia (POH). In addition to cutaneous ossification, AHO involves short stature, endocrinopathy, obesity, shortened fourth and fifth metacarpals, and mental retardation. Progressive osseous heteroplasia is characterized by progressive ossification of the skin and deeper tissues such as muscle and fascia, leading to severe movement restriction; it is believed to be a localized nonprogressive variant of POH.^3,4 Mutations in the guanine nucleotide binding protein, alpha stimulating activity polypeptide 1 gene, GNAS1, a key regulatory gene involved in AHO and POH, have been found in several cases of PLOC.³ Our patient lacked any dysmorphic features or laboratory abnormalities suggestive of AHO or POH. Moreover, testing of the tissue and blood for the GNAS1 mutation was negative. Treatment of PLOC often is difficult. Our patient underwent a trial of ablative fractional laser resurfacing, which failed to lead to perceivable improvement.  

The differential diagnoses include a kerion, dissecting cellulitis of the scalp, folliculitis decalvans, and acne keloidalis nuchae. A kerion is a manifestation of tinea capitis characterized by an inflammatory plaque, often with pain or tenderness. Kerions most frequently occur in children aged 5 to 10 years.⁵ Failure to treat a kerion may result in scarring alopecia. Treatment consists of oral antifungals.  

Dissecting cellulitis of the scalp is thought to occur secondary to follicular occlusion. It is characterized by boggy suppurative nodules primarily on the posterior and vertex scalp. Patchy hair loss is present and typically progresses to cicatricial alopecia. Histology characteristically shows areas of dense, predominantly neutrophilic, perifollicular dermal infiltrates.⁶ 

Folliculitis decalvans is a primary neutrophilic cicatricial alopecia that primarily occurs in adults. Patients with folliculitis decalvans tend to have multiple pustules on the periphery of confluent areas of scarring alopecia. It is theorized that an immune response to staphylococcal superantigens contributes to this disease process.⁷  

The clinical findings of acne keloidalis nuchae include inflammatory pustules and papules with keloidlike plaques on the posterior neck and scalp. It occurs predominantly in teenaged and adult males of African ancestry.⁸ Treatment is aimed at reducing inflammation and preventing exacerbating factors. Severe disease courses may lead to scarring alopecia.

The Food and Drug Administration has approved one formulation of azelastine (Astepro) nasal spray for nonprescription treatment of allergies, making it the first nasal antihistamine available over the counter in the United States.

The 0.15% strength of azelastine hydrochloride nasal spray is now approved for nonprescription treatment of seasonal and perennial allergic rhinitis in adults and children 6 years of age or older, the agency said. The 0.1% strength remains a prescription product that is indicated in younger children.

The “approval provides individuals an option for a safe and effective nasal antihistamine without requiring the assistance of a health care provider,” Theresa M. Michele, MD, director of the office of nonprescription drugs in the FDA’s Center for Drug Evaluation and Research, said in a prepared statement.

The FDA granted the nonprescription approval to Bayer Healthcare LLC, which said in a press release that the nasal spray would be available in national mass retail locations starting in the first quarter of 2022.

Oral antihistamines such as cetirizine (Zyrtec), loratadine (Claritin), and fexofenadine (Allegra) have been on store shelves for years. Azelastine 0.15% will be the first and only over-the-counter antihistamine for indoor and outdoor allergy relief in a nasal formulation, Bayer said.

An over-the-counter nasal antihistamine could be a better option for some allergy sufferers when compared with what is already over the counter, said Tracy Prematta, MD, a private practice allergist in Havertown, Pa.

“In general, I like the nasal antihistamines,” Dr. Prematta said in an interview. “They work quickly, whereas the nasal steroids don’t, and I think a lot of people who go to the drugstore looking for allergy relief are actually looking for something quick-acting.”

However, the cost of the over-the-counter azelastine may play a big role in whether patients go with the prescription or nonprescription option, according to Dr. Prematta.

Bayer has not yet set the price for nonprescription azelastine, a company spokesperson told this news organization.

The change in azelastine approval status happened through a regulatory process called an Rx-to-OTC switch. According to the FDA, products switched to nonprescription status need to have data demonstrating that they are safe and effective as self-medication when used as directed.

The product manufacturer has to show that consumers know how to use the drug safely and effectively without a health care professional supervising them, the FDA said.

The FDA considers the change in status for azelastine a partial Rx-to-OTC switch, since the 0.15% strength is now over the counter and the 0.1% strength remains a prescription product.

The 0.1% strength is indicated for perennial allergies in children 6 months to 6 years old, and seasonal allergies for children 2-6 years old, according to the FDA.

Drowsiness is a side effect of azelastine, the FDA said. According to prescribing information, consumers using the nasal spray need to be careful when driving or operating machinery, and should avoid alcohol.

Using the product with alcohol, sedatives, or tranquilizers may increase drowsiness, the agency added.

Sedation is also common with the oral antihistamines people take to treat their allergies, said Dr. Prematta, who added that patients may also complain of dry mouth, nose, or throat.

Although some allergy sufferers dislike the taste of antihistamine nasal spray, they can try to overcome that issue by tilting the head forward, pointing the tip of the nozzle toward the outside of the nose, and sniffing gently, Dr. Prematta said.

“That really minimizes what gets in the back of your throat, so taste becomes less of a problem,” she explained.

Dr. Prematta has disclosed no relevant financial relationships.
 

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

The Food and Drug Administration has approved one formulation of azelastine (Astepro) nasal spray for nonprescription treatment of allergies, making it the first nasal antihistamine available over the counter in the United States.

The 0.15% strength of azelastine hydrochloride nasal spray is now approved for nonprescription treatment of seasonal and perennial allergic rhinitis in adults and children 6 years of age or older, the agency said. The 0.1% strength remains a prescription product that is indicated in younger children.

The “approval provides individuals an option for a safe and effective nasal antihistamine without requiring the assistance of a health care provider,” Theresa M. Michele, MD, director of the office of nonprescription drugs in the FDA’s Center for Drug Evaluation and Research, said in a prepared statement.

The FDA granted the nonprescription approval to Bayer Healthcare LLC, which said in a press release that the nasal spray would be available in national mass retail locations starting in the first quarter of 2022.

Oral antihistamines such as cetirizine (Zyrtec), loratadine (Claritin), and fexofenadine (Allegra) have been on store shelves for years. Azelastine 0.15% will be the first and only over-the-counter antihistamine for indoor and outdoor allergy relief in a nasal formulation, Bayer said.

An over-the-counter nasal antihistamine could be a better option for some allergy sufferers when compared with what is already over the counter, said Tracy Prematta, MD, a private practice allergist in Havertown, Pa.

“In general, I like the nasal antihistamines,” Dr. Prematta said in an interview. “They work quickly, whereas the nasal steroids don’t, and I think a lot of people who go to the drugstore looking for allergy relief are actually looking for something quick-acting.”

However, the cost of the over-the-counter azelastine may play a big role in whether patients go with the prescription or nonprescription option, according to Dr. Prematta.

Bayer has not yet set the price for nonprescription azelastine, a company spokesperson told this news organization.

The change in azelastine approval status happened through a regulatory process called an Rx-to-OTC switch. According to the FDA, products switched to nonprescription status need to have data demonstrating that they are safe and effective as self-medication when used as directed.

The product manufacturer has to show that consumers know how to use the drug safely and effectively without a health care professional supervising them, the FDA said.

The FDA considers the change in status for azelastine a partial Rx-to-OTC switch, since the 0.15% strength is now over the counter and the 0.1% strength remains a prescription product.

The 0.1% strength is indicated for perennial allergies in children 6 months to 6 years old, and seasonal allergies for children 2-6 years old, according to the FDA.

Drowsiness is a side effect of azelastine, the FDA said. According to prescribing information, consumers using the nasal spray need to be careful when driving or operating machinery, and should avoid alcohol.

Using the product with alcohol, sedatives, or tranquilizers may increase drowsiness, the agency added.

Sedation is also common with the oral antihistamines people take to treat their allergies, said Dr. Prematta, who added that patients may also complain of dry mouth, nose, or throat.

Although some allergy sufferers dislike the taste of antihistamine nasal spray, they can try to overcome that issue by tilting the head forward, pointing the tip of the nozzle toward the outside of the nose, and sniffing gently, Dr. Prematta said.

“That really minimizes what gets in the back of your throat, so taste becomes less of a problem,” she explained.

Dr. Prematta has disclosed no relevant financial relationships.
 

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

The Food and Drug Administration has approved one formulation of azelastine (Astepro) nasal spray for nonprescription treatment of allergies, making it the first nasal antihistamine available over the counter in the United States.

The 0.15% strength of azelastine hydrochloride nasal spray is now approved for nonprescription treatment of seasonal and perennial allergic rhinitis in adults and children 6 years of age or older, the agency said. The 0.1% strength remains a prescription product that is indicated in younger children.

The “approval provides individuals an option for a safe and effective nasal antihistamine without requiring the assistance of a health care provider,” Theresa M. Michele, MD, director of the office of nonprescription drugs in the FDA’s Center for Drug Evaluation and Research, said in a prepared statement.

The FDA granted the nonprescription approval to Bayer Healthcare LLC, which said in a press release that the nasal spray would be available in national mass retail locations starting in the first quarter of 2022.

Oral antihistamines such as cetirizine (Zyrtec), loratadine (Claritin), and fexofenadine (Allegra) have been on store shelves for years. Azelastine 0.15% will be the first and only over-the-counter antihistamine for indoor and outdoor allergy relief in a nasal formulation, Bayer said.

An over-the-counter nasal antihistamine could be a better option for some allergy sufferers when compared with what is already over the counter, said Tracy Prematta, MD, a private practice allergist in Havertown, Pa.

“In general, I like the nasal antihistamines,” Dr. Prematta said in an interview. “They work quickly, whereas the nasal steroids don’t, and I think a lot of people who go to the drugstore looking for allergy relief are actually looking for something quick-acting.”

However, the cost of the over-the-counter azelastine may play a big role in whether patients go with the prescription or nonprescription option, according to Dr. Prematta.

Bayer has not yet set the price for nonprescription azelastine, a company spokesperson told this news organization.

The change in azelastine approval status happened through a regulatory process called an Rx-to-OTC switch. According to the FDA, products switched to nonprescription status need to have data demonstrating that they are safe and effective as self-medication when used as directed.

The product manufacturer has to show that consumers know how to use the drug safely and effectively without a health care professional supervising them, the FDA said.

The FDA considers the change in status for azelastine a partial Rx-to-OTC switch, since the 0.15% strength is now over the counter and the 0.1% strength remains a prescription product.

The 0.1% strength is indicated for perennial allergies in children 6 months to 6 years old, and seasonal allergies for children 2-6 years old, according to the FDA.

Drowsiness is a side effect of azelastine, the FDA said. According to prescribing information, consumers using the nasal spray need to be careful when driving or operating machinery, and should avoid alcohol.

Using the product with alcohol, sedatives, or tranquilizers may increase drowsiness, the agency added.

Sedation is also common with the oral antihistamines people take to treat their allergies, said Dr. Prematta, who added that patients may also complain of dry mouth, nose, or throat.

Although some allergy sufferers dislike the taste of antihistamine nasal spray, they can try to overcome that issue by tilting the head forward, pointing the tip of the nozzle toward the outside of the nose, and sniffing gently, Dr. Prematta said.

“That really minimizes what gets in the back of your throat, so taste becomes less of a problem,” she explained.

Dr. Prematta has disclosed no relevant financial relationships.
 

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

For many physicians and other professionals, aspirations of crafting a work of fiction are not uncommon — and with good reason. We are, after all, a generally well-disciplined bunch capable of completing complex tasks, and there is certainly no shortage of excitement and drama in medicine and surgery — ample fodder for thrilling stories. Nonetheless, writing a novel is a major commitment, and it requires persistence, patience, and dedicated time, especially for one with a busy medical career.

Getting started is not easy. Writing workshops are helpful, and in my case, I tried to mentor with some of the best. Before writing my novel, I attended workshops for aspiring novelists, given by noted physician authors Tess Gerritsen (Body Double, The Surgeon) and the late Michael Palmer (The Society, The Fifth Vial).

Writers are often advised to “write about what you know.” In my case, I combined my knowledge of medicine and my experience with the thoroughbred racing world to craft a thriller that one reviewer described as “Dick Francis meets Robin Cook.” For those who have never read the Dick Francis series, he was a renowned crime writer whose novels centered on horse racing in England. Having been an avid reader of both authors, that comparison was the ultimate compliment.

So against that backdrop, here is my distillation of 10 key points on the craft of writing a great thriller, based on my own experience in writing the novel Shedrow, along with some shared wisdom from a few legendary writers.

1. Start with the big “what if.” Any great story starts with that simple “what if” question. What if a series of high-profile executives in the managed care industry are serially murdered (Michael Palmer’s The Society)? What if a multimillion-dollar stallion dies suddenly under very mysterious circumstances on a supposedly secure farm in Kentucky (Dean DeLuke’s Shedrow)?

2. Put a MacGuffin to work in your story. Popularized by Alfred Hitchcock, the MacGuffin is that essential plot element that drives virtually all characters in the story, although it may be rather vague and meaningless to the story itself. In the iconic movie Pulp Fiction, the MacGuffin is the briefcase — everyone wants it, and we never do find out what’s in it.

3. Pacing is critical. Plot out the timeline of emotional highs and lows in a story. It should look like a rolling pattern of highs and lows that crescendo upward to the ultimate crisis. Take advantage of the fact that following any of those emotional peaks, you probably have the reader’s undivided attention. That would be a good time to provide backstory or fill in needed information for the reader – information that may be critical but perhaps not as exciting as what just transpired.

4. Torture your protagonists. Just when the reader thinks that the hero is finally home free, throw in another obstacle. Readers will empathize with the character and be drawn in by the unexpected hurdle.

5. Be original and surprise your readers. Create twists and turns that are totally unexpected, yet believable. This is easier said than done but will go a long way toward making your novel original, gripping, and unpredictable.

6. As a general rule, consider short sentences and short chapters. This is strictly a personal preference, but who can argue with James Patterson’s short chapters or with Robert Parker’s short and engaging sentences? Sentence length can be varied for effect, too, with shorter sentences serving to heighten action or increase tension.

7. Avoid the passive voice. Your readers want action. This is an important rule in almost any type of writing.

8. Keep descriptions brief. Long, drawn-out descriptions of the way characters look, or even setting descriptions, are easily overdone in a thriller. The thriller genre is very different from literary fiction in this regard. Stephen King advises writers to “just say what they see, then get on with the story.”

9. Sustain the reader’s interest throughout. Assess each chapter ending and determine whether the reader has been given enough reason to want to continue reading. Pose a question, end with a minor cliffhanger, or at least ensure that there is enough accumulated tension in the story.

10. Edit aggressively and cut out the fluff. Ernest Hemingway once confided to F. Scott Fitzgerald, “I write one page of masterpiece to 91 pages of shit. I try to put the shit in the wastebasket.”

Dr. DeLuke is professor emeritus of oral and facial surgery at Virginia Commonwealth University and author of the novel Shedrow.

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

For many physicians and other professionals, aspirations of crafting a work of fiction are not uncommon — and with good reason. We are, after all, a generally well-disciplined bunch capable of completing complex tasks, and there is certainly no shortage of excitement and drama in medicine and surgery — ample fodder for thrilling stories. Nonetheless, writing a novel is a major commitment, and it requires persistence, patience, and dedicated time, especially for one with a busy medical career.

Getting started is not easy. Writing workshops are helpful, and in my case, I tried to mentor with some of the best. Before writing my novel, I attended workshops for aspiring novelists, given by noted physician authors Tess Gerritsen (Body Double, The Surgeon) and the late Michael Palmer (The Society, The Fifth Vial).

Writers are often advised to “write about what you know.” In my case, I combined my knowledge of medicine and my experience with the thoroughbred racing world to craft a thriller that one reviewer described as “Dick Francis meets Robin Cook.” For those who have never read the Dick Francis series, he was a renowned crime writer whose novels centered on horse racing in England. Having been an avid reader of both authors, that comparison was the ultimate compliment.

So against that backdrop, here is my distillation of 10 key points on the craft of writing a great thriller, based on my own experience in writing the novel Shedrow, along with some shared wisdom from a few legendary writers.

1. Start with the big “what if.” Any great story starts with that simple “what if” question. What if a series of high-profile executives in the managed care industry are serially murdered (Michael Palmer’s The Society)? What if a multimillion-dollar stallion dies suddenly under very mysterious circumstances on a supposedly secure farm in Kentucky (Dean DeLuke’s Shedrow)?

2. Put a MacGuffin to work in your story. Popularized by Alfred Hitchcock, the MacGuffin is that essential plot element that drives virtually all characters in the story, although it may be rather vague and meaningless to the story itself. In the iconic movie Pulp Fiction, the MacGuffin is the briefcase — everyone wants it, and we never do find out what’s in it.

3. Pacing is critical. Plot out the timeline of emotional highs and lows in a story. It should look like a rolling pattern of highs and lows that crescendo upward to the ultimate crisis. Take advantage of the fact that following any of those emotional peaks, you probably have the reader’s undivided attention. That would be a good time to provide backstory or fill in needed information for the reader – information that may be critical but perhaps not as exciting as what just transpired.

4. Torture your protagonists. Just when the reader thinks that the hero is finally home free, throw in another obstacle. Readers will empathize with the character and be drawn in by the unexpected hurdle.

5. Be original and surprise your readers. Create twists and turns that are totally unexpected, yet believable. This is easier said than done but will go a long way toward making your novel original, gripping, and unpredictable.

6. As a general rule, consider short sentences and short chapters. This is strictly a personal preference, but who can argue with James Patterson’s short chapters or with Robert Parker’s short and engaging sentences? Sentence length can be varied for effect, too, with shorter sentences serving to heighten action or increase tension.

7. Avoid the passive voice. Your readers want action. This is an important rule in almost any type of writing.

8. Keep descriptions brief. Long, drawn-out descriptions of the way characters look, or even setting descriptions, are easily overdone in a thriller. The thriller genre is very different from literary fiction in this regard. Stephen King advises writers to “just say what they see, then get on with the story.”

9. Sustain the reader’s interest throughout. Assess each chapter ending and determine whether the reader has been given enough reason to want to continue reading. Pose a question, end with a minor cliffhanger, or at least ensure that there is enough accumulated tension in the story.

10. Edit aggressively and cut out the fluff. Ernest Hemingway once confided to F. Scott Fitzgerald, “I write one page of masterpiece to 91 pages of shit. I try to put the shit in the wastebasket.”

Dr. DeLuke is professor emeritus of oral and facial surgery at Virginia Commonwealth University and author of the novel Shedrow.

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

For many physicians and other professionals, aspirations of crafting a work of fiction are not uncommon — and with good reason. We are, after all, a generally well-disciplined bunch capable of completing complex tasks, and there is certainly no shortage of excitement and drama in medicine and surgery — ample fodder for thrilling stories. Nonetheless, writing a novel is a major commitment, and it requires persistence, patience, and dedicated time, especially for one with a busy medical career.

Getting started is not easy. Writing workshops are helpful, and in my case, I tried to mentor with some of the best. Before writing my novel, I attended workshops for aspiring novelists, given by noted physician authors Tess Gerritsen (Body Double, The Surgeon) and the late Michael Palmer (The Society, The Fifth Vial).

Writers are often advised to “write about what you know.” In my case, I combined my knowledge of medicine and my experience with the thoroughbred racing world to craft a thriller that one reviewer described as “Dick Francis meets Robin Cook.” For those who have never read the Dick Francis series, he was a renowned crime writer whose novels centered on horse racing in England. Having been an avid reader of both authors, that comparison was the ultimate compliment.

So against that backdrop, here is my distillation of 10 key points on the craft of writing a great thriller, based on my own experience in writing the novel Shedrow, along with some shared wisdom from a few legendary writers.

1. Start with the big “what if.” Any great story starts with that simple “what if” question. What if a series of high-profile executives in the managed care industry are serially murdered (Michael Palmer’s The Society)? What if a multimillion-dollar stallion dies suddenly under very mysterious circumstances on a supposedly secure farm in Kentucky (Dean DeLuke’s Shedrow)?

2. Put a MacGuffin to work in your story. Popularized by Alfred Hitchcock, the MacGuffin is that essential plot element that drives virtually all characters in the story, although it may be rather vague and meaningless to the story itself. In the iconic movie Pulp Fiction, the MacGuffin is the briefcase — everyone wants it, and we never do find out what’s in it.

3. Pacing is critical. Plot out the timeline of emotional highs and lows in a story. It should look like a rolling pattern of highs and lows that crescendo upward to the ultimate crisis. Take advantage of the fact that following any of those emotional peaks, you probably have the reader’s undivided attention. That would be a good time to provide backstory or fill in needed information for the reader – information that may be critical but perhaps not as exciting as what just transpired.

4. Torture your protagonists. Just when the reader thinks that the hero is finally home free, throw in another obstacle. Readers will empathize with the character and be drawn in by the unexpected hurdle.

5. Be original and surprise your readers. Create twists and turns that are totally unexpected, yet believable. This is easier said than done but will go a long way toward making your novel original, gripping, and unpredictable.

6. As a general rule, consider short sentences and short chapters. This is strictly a personal preference, but who can argue with James Patterson’s short chapters or with Robert Parker’s short and engaging sentences? Sentence length can be varied for effect, too, with shorter sentences serving to heighten action or increase tension.

7. Avoid the passive voice. Your readers want action. This is an important rule in almost any type of writing.

8. Keep descriptions brief. Long, drawn-out descriptions of the way characters look, or even setting descriptions, are easily overdone in a thriller. The thriller genre is very different from literary fiction in this regard. Stephen King advises writers to “just say what they see, then get on with the story.”

9. Sustain the reader’s interest throughout. Assess each chapter ending and determine whether the reader has been given enough reason to want to continue reading. Pose a question, end with a minor cliffhanger, or at least ensure that there is enough accumulated tension in the story.

10. Edit aggressively and cut out the fluff. Ernest Hemingway once confided to F. Scott Fitzgerald, “I write one page of masterpiece to 91 pages of shit. I try to put the shit in the wastebasket.”

Dr. DeLuke is professor emeritus of oral and facial surgery at Virginia Commonwealth University and author of the novel Shedrow.

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

Allergic conjunctivitis harms quality of life for children and their parents, apparently causing greater day-to-day worries than potentially blinding diseases, researchers report.

Parents worry especially that treatments might not be effective, according to Shi-yao Zhang, MD, and colleagues from Sun Yat-sen University, Guangzhou, China. “This finding suggests that more communication with parents regarding treatment and prognosis is needed,” they write in an article published online June 10 in JAMA Ophthalmology.

One of the most prevalent eye disorders in children, allergic conjunctivitis is often chronic, leading patients to ask repeatedly for help from physicians. It can take an emotional toll and can cause children to miss school.

“With any sign of a slightly pink eye [or a] runny nose, which are very common with allergies, children are being sent home, because everyone’s concerned about COVID,” said Yi Ning J. Strube, MD, an associate professor of ophthalmology and pediatrics at Queen’s University, Kingston, Canada, whose commentary appears in the same issue of JAMA Ophthalmology.

Adolescents are also sometimes accused of smoking cannabis because of their red eyes, she said.

However, little research has examined the effects of allergic conjunctivitis on the quality of life of children and their guardians, Dr. Zhang and colleagues write. To fill that gap, the researchers administered the Pediatric Quality of Life Inventory (PedsQL) to 92 children with allergic conjunctivitis and their parents. The children were aged 5 to 18 years.

The researchers administered the same questionnaire to 96 healthy children of the same ages, along with their parents. These participants served as a control group.

On a scale of 0 to 100, in which a higher score signifies a better quality of life, the median total PedsQL score was 69.6 for children with allergic conjunctivitis versus 96.7 for the control group.

Subscores of physical, emotional, social, and especially school functioning were all significantly lower for the children with allergic conjunctivitis than for the control persons. “Because children generally spend most of their time in the school environment, this outcome raises an issue regarding whether children have a poorer performance in their education,” Dr. Zhang and colleagues write.

Dr. Strube recommends that physicians educate their patients about allergic conjunctivitis using handouts or high-quality websites. She often refers patients and their families to the allergic conjunctivitis webpage of the American Academy of Pediatric Ophthalmology and Strabismus.

She tells parents to have their child “take a shower and wash their hair when they get home before they rub their pollen-filled hair on their pillowcase and make their allergy symptoms worse.”

Parents and schools should try to filter pollen and other allergens from indoor air, she added.

Parents of the children with allergic conjunctivitis in the study also reported lower quality of life; they scored 68.8, versus 96.5 for parents of children in the control group. The differences for both parents and children were statistically significant (P < .001). Overall, the parents’ quality-of-life scores correlated with their children’s (correlation coefficient, r = 0.59; P < .001).

Children with vernal or atopic keratoconjunctivitis scored 3.3 points lower on health-related quality of life than those with seasonal allergic conjunctivitis.

Children with higher corneal fluorescein staining scores also had lower quality-of-life scores. Parents whose children had higher corneal fluorescein staining scores and also those who had multiple consultations with health care practitioners also reported lower quality of life.

The quality-of-life scores of the children with allergic conjunctivitis were lower than scores in previous studies for children with vision-threatening diseases, such as glaucoma and congenital cataract. This may be because glaucoma and cataracts do not typically cause discomfort even if they impair the patient’s vision, said Dr. Strube.

She pointed out one potential flaw in the study: In the cohort with allergic conjunctivitis, 83.7% were boys, compared to 42.7% of the control group. Vernal keratoconjunctivitis affects more boys than girls, and not controlling for this factor could have confounded the data, Dr. Strube said.

It could also be useful to replicate the study in other countries to see whether geographic or cultural factors affected the results, she said. “A lot of these big centers around the world, including in China, have poor air quality, so that may be contributing to patients’ symptoms,” she said. “With regards to reported health quality of life and impact on education, results from different parts of the world may be different, due to parenting styles and education styles,” she said.

The study was supported by the National Natural Science Foundation of China and the Science Foundation of Guangdong Province. Dr. Zhang and colleagues reported no relevant financial relationships. Dr. Strube reported receiving personal fees from Santen Canada Advisory Board Consultant outside the submitted work.

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

Allergic conjunctivitis harms quality of life for children and their parents, apparently causing greater day-to-day worries than potentially blinding diseases, researchers report.

Parents worry especially that treatments might not be effective, according to Shi-yao Zhang, MD, and colleagues from Sun Yat-sen University, Guangzhou, China. “This finding suggests that more communication with parents regarding treatment and prognosis is needed,” they write in an article published online June 10 in JAMA Ophthalmology.

One of the most prevalent eye disorders in children, allergic conjunctivitis is often chronic, leading patients to ask repeatedly for help from physicians. It can take an emotional toll and can cause children to miss school.

“With any sign of a slightly pink eye [or a] runny nose, which are very common with allergies, children are being sent home, because everyone’s concerned about COVID,” said Yi Ning J. Strube, MD, an associate professor of ophthalmology and pediatrics at Queen’s University, Kingston, Canada, whose commentary appears in the same issue of JAMA Ophthalmology.

Adolescents are also sometimes accused of smoking cannabis because of their red eyes, she said.

However, little research has examined the effects of allergic conjunctivitis on the quality of life of children and their guardians, Dr. Zhang and colleagues write. To fill that gap, the researchers administered the Pediatric Quality of Life Inventory (PedsQL) to 92 children with allergic conjunctivitis and their parents. The children were aged 5 to 18 years.

The researchers administered the same questionnaire to 96 healthy children of the same ages, along with their parents. These participants served as a control group.

On a scale of 0 to 100, in which a higher score signifies a better quality of life, the median total PedsQL score was 69.6 for children with allergic conjunctivitis versus 96.7 for the control group.

Subscores of physical, emotional, social, and especially school functioning were all significantly lower for the children with allergic conjunctivitis than for the control persons. “Because children generally spend most of their time in the school environment, this outcome raises an issue regarding whether children have a poorer performance in their education,” Dr. Zhang and colleagues write.

Dr. Strube recommends that physicians educate their patients about allergic conjunctivitis using handouts or high-quality websites. She often refers patients and their families to the allergic conjunctivitis webpage of the American Academy of Pediatric Ophthalmology and Strabismus.

She tells parents to have their child “take a shower and wash their hair when they get home before they rub their pollen-filled hair on their pillowcase and make their allergy symptoms worse.”

Parents and schools should try to filter pollen and other allergens from indoor air, she added.

Parents of the children with allergic conjunctivitis in the study also reported lower quality of life; they scored 68.8, versus 96.5 for parents of children in the control group. The differences for both parents and children were statistically significant (P < .001). Overall, the parents’ quality-of-life scores correlated with their children’s (correlation coefficient, r = 0.59; P < .001).

Children with vernal or atopic keratoconjunctivitis scored 3.3 points lower on health-related quality of life than those with seasonal allergic conjunctivitis.

Children with higher corneal fluorescein staining scores also had lower quality-of-life scores. Parents whose children had higher corneal fluorescein staining scores and also those who had multiple consultations with health care practitioners also reported lower quality of life.

The quality-of-life scores of the children with allergic conjunctivitis were lower than scores in previous studies for children with vision-threatening diseases, such as glaucoma and congenital cataract. This may be because glaucoma and cataracts do not typically cause discomfort even if they impair the patient’s vision, said Dr. Strube.

She pointed out one potential flaw in the study: In the cohort with allergic conjunctivitis, 83.7% were boys, compared to 42.7% of the control group. Vernal keratoconjunctivitis affects more boys than girls, and not controlling for this factor could have confounded the data, Dr. Strube said.

It could also be useful to replicate the study in other countries to see whether geographic or cultural factors affected the results, she said. “A lot of these big centers around the world, including in China, have poor air quality, so that may be contributing to patients’ symptoms,” she said. “With regards to reported health quality of life and impact on education, results from different parts of the world may be different, due to parenting styles and education styles,” she said.

The study was supported by the National Natural Science Foundation of China and the Science Foundation of Guangdong Province. Dr. Zhang and colleagues reported no relevant financial relationships. Dr. Strube reported receiving personal fees from Santen Canada Advisory Board Consultant outside the submitted work.

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

Allergic conjunctivitis harms quality of life for children and their parents, apparently causing greater day-to-day worries than potentially blinding diseases, researchers report.

Parents worry especially that treatments might not be effective, according to Shi-yao Zhang, MD, and colleagues from Sun Yat-sen University, Guangzhou, China. “This finding suggests that more communication with parents regarding treatment and prognosis is needed,” they write in an article published online June 10 in JAMA Ophthalmology.

One of the most prevalent eye disorders in children, allergic conjunctivitis is often chronic, leading patients to ask repeatedly for help from physicians. It can take an emotional toll and can cause children to miss school.

“With any sign of a slightly pink eye [or a] runny nose, which are very common with allergies, children are being sent home, because everyone’s concerned about COVID,” said Yi Ning J. Strube, MD, an associate professor of ophthalmology and pediatrics at Queen’s University, Kingston, Canada, whose commentary appears in the same issue of JAMA Ophthalmology.

Adolescents are also sometimes accused of smoking cannabis because of their red eyes, she said.

However, little research has examined the effects of allergic conjunctivitis on the quality of life of children and their guardians, Dr. Zhang and colleagues write. To fill that gap, the researchers administered the Pediatric Quality of Life Inventory (PedsQL) to 92 children with allergic conjunctivitis and their parents. The children were aged 5 to 18 years.

The researchers administered the same questionnaire to 96 healthy children of the same ages, along with their parents. These participants served as a control group.

On a scale of 0 to 100, in which a higher score signifies a better quality of life, the median total PedsQL score was 69.6 for children with allergic conjunctivitis versus 96.7 for the control group.

Subscores of physical, emotional, social, and especially school functioning were all significantly lower for the children with allergic conjunctivitis than for the control persons. “Because children generally spend most of their time in the school environment, this outcome raises an issue regarding whether children have a poorer performance in their education,” Dr. Zhang and colleagues write.

Dr. Strube recommends that physicians educate their patients about allergic conjunctivitis using handouts or high-quality websites. She often refers patients and their families to the allergic conjunctivitis webpage of the American Academy of Pediatric Ophthalmology and Strabismus.

She tells parents to have their child “take a shower and wash their hair when they get home before they rub their pollen-filled hair on their pillowcase and make their allergy symptoms worse.”

Parents and schools should try to filter pollen and other allergens from indoor air, she added.

Parents of the children with allergic conjunctivitis in the study also reported lower quality of life; they scored 68.8, versus 96.5 for parents of children in the control group. The differences for both parents and children were statistically significant (P < .001). Overall, the parents’ quality-of-life scores correlated with their children’s (correlation coefficient, r = 0.59; P < .001).

Children with vernal or atopic keratoconjunctivitis scored 3.3 points lower on health-related quality of life than those with seasonal allergic conjunctivitis.

Children with higher corneal fluorescein staining scores also had lower quality-of-life scores. Parents whose children had higher corneal fluorescein staining scores and also those who had multiple consultations with health care practitioners also reported lower quality of life.

The quality-of-life scores of the children with allergic conjunctivitis were lower than scores in previous studies for children with vision-threatening diseases, such as glaucoma and congenital cataract. This may be because glaucoma and cataracts do not typically cause discomfort even if they impair the patient’s vision, said Dr. Strube.

She pointed out one potential flaw in the study: In the cohort with allergic conjunctivitis, 83.7% were boys, compared to 42.7% of the control group. Vernal keratoconjunctivitis affects more boys than girls, and not controlling for this factor could have confounded the data, Dr. Strube said.

It could also be useful to replicate the study in other countries to see whether geographic or cultural factors affected the results, she said. “A lot of these big centers around the world, including in China, have poor air quality, so that may be contributing to patients’ symptoms,” she said. “With regards to reported health quality of life and impact on education, results from different parts of the world may be different, due to parenting styles and education styles,” she said.

The study was supported by the National Natural Science Foundation of China and the Science Foundation of Guangdong Province. Dr. Zhang and colleagues reported no relevant financial relationships. Dr. Strube reported receiving personal fees from Santen Canada Advisory Board Consultant outside the submitted work.

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

Nearly all Americans say that sun protection is important, but almost half don’t use sunscreen regularly and more than a third believe that tanning is healthy, according to the results of a recent survey commissioned by the American Academy of Dermatology.

With the pandemic seemingly behind it, the United States enters the summer months facing the paradox of sun protection. Four out of five adults know that sunscreen should be reapplied every 2 hours when they’re outdoors, but only one in three make the actual effort, and 77% are likely to use sunscreen at the beach or a pool, compared with 41% when they’re gardening or working outside on their homes, the AAD reported.

“These findings are surprising and seem to suggest that many people do not take skin cancer seriously or perhaps believe skin cancer won’t happen to them,” Robert T. Brodell, MD, professor of dermatology at the University of Mississippi Medical Center, Jackson, said in a written statement from the AAD, adding that “unprotected exposure to ultraviolet rays is the most preventable risk factor for skin cancer, including melanoma.”

A quarter of all survey respondents reported getting sunburned in 2020, with the youngest adults most likely to feel the wrath of the sun. Sunburn was reported by 43% of those aged 18-23 years, 37% of those aged 24-39, 25% of the 40- to 55-year-olds, 12% of the 56- to 74-year-olds, and 7% of those aged 75 and older. More than a quarter of those who got sunburned said that it was bad enough to make their clothes feel uncomfortable, the academy said.

“Americans see the damaging effects of the sun on their skin as they get older, and two out of three look back and wish they had been more careful. But when it comes to cancer, specifically, most feel unconcerned in spite of their own risk,” according to a statement from Versta Research, which conducted the poll on behalf of the AAD. The survey was conducted from Feb. 22 to March 10, 2021, and involved 1,056 respondents, with a ±3% margin of error.

The lack of concern for skin cancer looks like this: More than two-thirds of the respondents (69%) have at least one possible risk factor – lighter skin tone, blue or green eyes, more than 50 moles, family history – but only 36% expressed concern about developing it. “Indeed, half of survey respondents (49%) say they are more worried about avoiding sunburn than they are about preventing skin cancer, and a third (32%) are more worried about avoiding premature wrinkles than they are about preventing cancer,” the AAD said.

The AAD is considering the creation of a social media quiz or interactive tool, and if the results of this survey were recast as a potential “Knowledge and Awareness Quiz” and graded with a traditional scheme (A = 90%-100%, B = 80%-89%, etc.), then 34% of the respondents would have failed, 15% would have gotten a D, and only 5% would have earned an A, the academy noted.

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Nearly all Americans say that sun protection is important, but almost half don’t use sunscreen regularly and more than a third believe that tanning is healthy, according to the results of a recent survey commissioned by the American Academy of Dermatology.

With the pandemic seemingly behind it, the United States enters the summer months facing the paradox of sun protection. Four out of five adults know that sunscreen should be reapplied every 2 hours when they’re outdoors, but only one in three make the actual effort, and 77% are likely to use sunscreen at the beach or a pool, compared with 41% when they’re gardening or working outside on their homes, the AAD reported.

“These findings are surprising and seem to suggest that many people do not take skin cancer seriously or perhaps believe skin cancer won’t happen to them,” Robert T. Brodell, MD, professor of dermatology at the University of Mississippi Medical Center, Jackson, said in a written statement from the AAD, adding that “unprotected exposure to ultraviolet rays is the most preventable risk factor for skin cancer, including melanoma.”

A quarter of all survey respondents reported getting sunburned in 2020, with the youngest adults most likely to feel the wrath of the sun. Sunburn was reported by 43% of those aged 18-23 years, 37% of those aged 24-39, 25% of the 40- to 55-year-olds, 12% of the 56- to 74-year-olds, and 7% of those aged 75 and older. More than a quarter of those who got sunburned said that it was bad enough to make their clothes feel uncomfortable, the academy said.

“Americans see the damaging effects of the sun on their skin as they get older, and two out of three look back and wish they had been more careful. But when it comes to cancer, specifically, most feel unconcerned in spite of their own risk,” according to a statement from Versta Research, which conducted the poll on behalf of the AAD. The survey was conducted from Feb. 22 to March 10, 2021, and involved 1,056 respondents, with a ±3% margin of error.

The lack of concern for skin cancer looks like this: More than two-thirds of the respondents (69%) have at least one possible risk factor – lighter skin tone, blue or green eyes, more than 50 moles, family history – but only 36% expressed concern about developing it. “Indeed, half of survey respondents (49%) say they are more worried about avoiding sunburn than they are about preventing skin cancer, and a third (32%) are more worried about avoiding premature wrinkles than they are about preventing cancer,” the AAD said.

The AAD is considering the creation of a social media quiz or interactive tool, and if the results of this survey were recast as a potential “Knowledge and Awareness Quiz” and graded with a traditional scheme (A = 90%-100%, B = 80%-89%, etc.), then 34% of the respondents would have failed, 15% would have gotten a D, and only 5% would have earned an A, the academy noted.

[email protected]

Nearly all Americans say that sun protection is important, but almost half don’t use sunscreen regularly and more than a third believe that tanning is healthy, according to the results of a recent survey commissioned by the American Academy of Dermatology.

With the pandemic seemingly behind it, the United States enters the summer months facing the paradox of sun protection. Four out of five adults know that sunscreen should be reapplied every 2 hours when they’re outdoors, but only one in three make the actual effort, and 77% are likely to use sunscreen at the beach or a pool, compared with 41% when they’re gardening or working outside on their homes, the AAD reported.

“These findings are surprising and seem to suggest that many people do not take skin cancer seriously or perhaps believe skin cancer won’t happen to them,” Robert T. Brodell, MD, professor of dermatology at the University of Mississippi Medical Center, Jackson, said in a written statement from the AAD, adding that “unprotected exposure to ultraviolet rays is the most preventable risk factor for skin cancer, including melanoma.”

A quarter of all survey respondents reported getting sunburned in 2020, with the youngest adults most likely to feel the wrath of the sun. Sunburn was reported by 43% of those aged 18-23 years, 37% of those aged 24-39, 25% of the 40- to 55-year-olds, 12% of the 56- to 74-year-olds, and 7% of those aged 75 and older. More than a quarter of those who got sunburned said that it was bad enough to make their clothes feel uncomfortable, the academy said.

“Americans see the damaging effects of the sun on their skin as they get older, and two out of three look back and wish they had been more careful. But when it comes to cancer, specifically, most feel unconcerned in spite of their own risk,” according to a statement from Versta Research, which conducted the poll on behalf of the AAD. The survey was conducted from Feb. 22 to March 10, 2021, and involved 1,056 respondents, with a ±3% margin of error.

The lack of concern for skin cancer looks like this: More than two-thirds of the respondents (69%) have at least one possible risk factor – lighter skin tone, blue or green eyes, more than 50 moles, family history – but only 36% expressed concern about developing it. “Indeed, half of survey respondents (49%) say they are more worried about avoiding sunburn than they are about preventing skin cancer, and a third (32%) are more worried about avoiding premature wrinkles than they are about preventing cancer,” the AAD said.

The AAD is considering the creation of a social media quiz or interactive tool, and if the results of this survey were recast as a potential “Knowledge and Awareness Quiz” and graded with a traditional scheme (A = 90%-100%, B = 80%-89%, etc.), then 34% of the respondents would have failed, 15% would have gotten a D, and only 5% would have earned an A, the academy noted.

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A large proportion of initial Investigator Global Assessment (IGA) 0/1 or Eczema Area and Severity Index (EASI) 75 responders at week 16 maintained response with continued tralokinumab dosing every 2 weeks or every 4 weeks during a 36-week maintenance period without the use of rescue medication including topical corticosteroids, results from a pooled analysis of two trials found.

“The interesting thing here is that there weren’t major differences in the maintenance dosing, which really allows us some flexibility with maintenance dosing for this particular drug,” lead study investigator Andrew Blauvelt, MD, MBA, said during the Revolutionizing Atopic Dermatitis symposium.

Administered subcutaneously, tralokinumab is a fully human IgG4 monoclonal antibody that specifically binds to interleukin-13, a key driver of underlying inflammation in AD. In two of the drug’s pivotal phase 3 trials, ECZTRA 1 and ECZTRA 2, tralokinumab monotherapy was superior to placebo at week 16 for all primary and secondary endpoints.

The purpose of the current trial was to investigate the maintenance of efficacy after 16 weeks of tralokinumab in those who were initial responders and to assess the efficacy of reduced dosing frequency from 300 mg every 2 weeks to 300 mg every 4 weeks after a 36-week maintenance phase. Patients who used rescue medication, including topical corticosteroids, were considered to be nonresponders.

Dr. Blauvelt reported results from 1,596 adult patients with a mean age of 38 years who were randomized to tralokinumab 300 mg every 2 weeks or placebo in the initial treatment period. At baseline, the mean duration of AD was 28.2 years, 50% had severe disease based on their IGA score, and their mean Dermatology Life Quality Index score was 17.

Of these patients, 412 achieved an IGA score of 0 or 1 and/or an EASI 75 at week 16 with tralokinumab every 2 weeks and were rerandomized (2:2:1) to continue tralokinumab 300 mg every 2 weeks, tralokinumab 300 mg every 4 weeks, or placebo for 36 weeks.

The researchers found that 56%-57% of patients in the tralokinumab every 2-week dosing group maintained their IGA 0/1 and EASI 75 response at week 52, compared with 42%-50% of those who received the drug every 4 weeks. “So, there may be a population of patients who require drug every 4 weeks after initially receiving the drug every 2 weeks for the first 16 weeks,” said Dr. Blauvelt, a dermatologist who is president of Oregon Medical Research Center, Portland. “Interestingly, 26%-34% of patients on placebo maintained their IGA 0/1 and EASI 75 response a response to week 52. Perhaps those are patients who have more mild disease or more episodic disease when they started this trial.”

He also noted that time to relapse based on their IGA 0/1 and EASI 75 was prolonged with tralokinumab treatment, compared with placebo, and adverse event frequency was similar among all treatment groups (73% among those who received tralokinumab every 2 weeks, 66% among those who received tralokinumab every 4 weeks, and 70% in the placebo group).

Dr. Blauvelt concluded that a step-down in tralokinumab dosing to every 4 weeks may be an option for some patients achieving clear or almost clear skin after an initial dosing schedule of every 2 weeks.

LEO Pharma, which is developing tralokinumab, sponsored the analysis. Dr. Blauvelt reported that he is an investigator and a scientific adviser for LEO Pharma and for several other pharmaceutical companies developing treatments for AD.

[email protected]

A large proportion of initial Investigator Global Assessment (IGA) 0/1 or Eczema Area and Severity Index (EASI) 75 responders at week 16 maintained response with continued tralokinumab dosing every 2 weeks or every 4 weeks during a 36-week maintenance period without the use of rescue medication including topical corticosteroids, results from a pooled analysis of two trials found.

“The interesting thing here is that there weren’t major differences in the maintenance dosing, which really allows us some flexibility with maintenance dosing for this particular drug,” lead study investigator Andrew Blauvelt, MD, MBA, said during the Revolutionizing Atopic Dermatitis symposium.

Administered subcutaneously, tralokinumab is a fully human IgG4 monoclonal antibody that specifically binds to interleukin-13, a key driver of underlying inflammation in AD. In two of the drug’s pivotal phase 3 trials, ECZTRA 1 and ECZTRA 2, tralokinumab monotherapy was superior to placebo at week 16 for all primary and secondary endpoints.

The purpose of the current trial was to investigate the maintenance of efficacy after 16 weeks of tralokinumab in those who were initial responders and to assess the efficacy of reduced dosing frequency from 300 mg every 2 weeks to 300 mg every 4 weeks after a 36-week maintenance phase. Patients who used rescue medication, including topical corticosteroids, were considered to be nonresponders.

Dr. Blauvelt reported results from 1,596 adult patients with a mean age of 38 years who were randomized to tralokinumab 300 mg every 2 weeks or placebo in the initial treatment period. At baseline, the mean duration of AD was 28.2 years, 50% had severe disease based on their IGA score, and their mean Dermatology Life Quality Index score was 17.

Of these patients, 412 achieved an IGA score of 0 or 1 and/or an EASI 75 at week 16 with tralokinumab every 2 weeks and were rerandomized (2:2:1) to continue tralokinumab 300 mg every 2 weeks, tralokinumab 300 mg every 4 weeks, or placebo for 36 weeks.

The researchers found that 56%-57% of patients in the tralokinumab every 2-week dosing group maintained their IGA 0/1 and EASI 75 response at week 52, compared with 42%-50% of those who received the drug every 4 weeks. “So, there may be a population of patients who require drug every 4 weeks after initially receiving the drug every 2 weeks for the first 16 weeks,” said Dr. Blauvelt, a dermatologist who is president of Oregon Medical Research Center, Portland. “Interestingly, 26%-34% of patients on placebo maintained their IGA 0/1 and EASI 75 response a response to week 52. Perhaps those are patients who have more mild disease or more episodic disease when they started this trial.”

He also noted that time to relapse based on their IGA 0/1 and EASI 75 was prolonged with tralokinumab treatment, compared with placebo, and adverse event frequency was similar among all treatment groups (73% among those who received tralokinumab every 2 weeks, 66% among those who received tralokinumab every 4 weeks, and 70% in the placebo group).

Dr. Blauvelt concluded that a step-down in tralokinumab dosing to every 4 weeks may be an option for some patients achieving clear or almost clear skin after an initial dosing schedule of every 2 weeks.

LEO Pharma, which is developing tralokinumab, sponsored the analysis. Dr. Blauvelt reported that he is an investigator and a scientific adviser for LEO Pharma and for several other pharmaceutical companies developing treatments for AD.

[email protected]

A large proportion of initial Investigator Global Assessment (IGA) 0/1 or Eczema Area and Severity Index (EASI) 75 responders at week 16 maintained response with continued tralokinumab dosing every 2 weeks or every 4 weeks during a 36-week maintenance period without the use of rescue medication including topical corticosteroids, results from a pooled analysis of two trials found.

“The interesting thing here is that there weren’t major differences in the maintenance dosing, which really allows us some flexibility with maintenance dosing for this particular drug,” lead study investigator Andrew Blauvelt, MD, MBA, said during the Revolutionizing Atopic Dermatitis symposium.

Administered subcutaneously, tralokinumab is a fully human IgG4 monoclonal antibody that specifically binds to interleukin-13, a key driver of underlying inflammation in AD. In two of the drug’s pivotal phase 3 trials, ECZTRA 1 and ECZTRA 2, tralokinumab monotherapy was superior to placebo at week 16 for all primary and secondary endpoints.

The purpose of the current trial was to investigate the maintenance of efficacy after 16 weeks of tralokinumab in those who were initial responders and to assess the efficacy of reduced dosing frequency from 300 mg every 2 weeks to 300 mg every 4 weeks after a 36-week maintenance phase. Patients who used rescue medication, including topical corticosteroids, were considered to be nonresponders.

Dr. Blauvelt reported results from 1,596 adult patients with a mean age of 38 years who were randomized to tralokinumab 300 mg every 2 weeks or placebo in the initial treatment period. At baseline, the mean duration of AD was 28.2 years, 50% had severe disease based on their IGA score, and their mean Dermatology Life Quality Index score was 17.

Of these patients, 412 achieved an IGA score of 0 or 1 and/or an EASI 75 at week 16 with tralokinumab every 2 weeks and were rerandomized (2:2:1) to continue tralokinumab 300 mg every 2 weeks, tralokinumab 300 mg every 4 weeks, or placebo for 36 weeks.

The researchers found that 56%-57% of patients in the tralokinumab every 2-week dosing group maintained their IGA 0/1 and EASI 75 response at week 52, compared with 42%-50% of those who received the drug every 4 weeks. “So, there may be a population of patients who require drug every 4 weeks after initially receiving the drug every 2 weeks for the first 16 weeks,” said Dr. Blauvelt, a dermatologist who is president of Oregon Medical Research Center, Portland. “Interestingly, 26%-34% of patients on placebo maintained their IGA 0/1 and EASI 75 response a response to week 52. Perhaps those are patients who have more mild disease or more episodic disease when they started this trial.”

He also noted that time to relapse based on their IGA 0/1 and EASI 75 was prolonged with tralokinumab treatment, compared with placebo, and adverse event frequency was similar among all treatment groups (73% among those who received tralokinumab every 2 weeks, 66% among those who received tralokinumab every 4 weeks, and 70% in the placebo group).

Dr. Blauvelt concluded that a step-down in tralokinumab dosing to every 4 weeks may be an option for some patients achieving clear or almost clear skin after an initial dosing schedule of every 2 weeks.

LEO Pharma, which is developing tralokinumab, sponsored the analysis. Dr. Blauvelt reported that he is an investigator and a scientific adviser for LEO Pharma and for several other pharmaceutical companies developing treatments for AD.

[email protected]

One in 15 patients who start dupilumab treatment may develop conjunctivitis during the first 6 months, most of which is manageable with ophthalmic treatments, results from large study of U.S. claims data showed.

“About 4 years after dupilumab’s approval, we’re interested in how conjunctivitis has played out in our daily clinical practice,” lead study investigator Maria C. Schneeweiss, MD, said during the Revolutionizing Atopic Dermatitis symposium.

Drawing from two nationwide U.S. databases, MarketScan and Optum, Dr. Schneeweiss, of the department of dermatology at Brigham and Women’s Hospital, Boston, and colleagues sought to characterize the incidence of bacterial and nonbacterial conjunctivitis among 6,730 patients with AD who started treatment with either dupilumab, methotrexate, mycophenolate, or cyclosporine between March 2017 and January 2020. They also wanted to identify patient subgroups at increased or decreased risk of dupilumab-related conjunctivitis in clinical practice.

Of the 6,730 patients, 3,755 started treatment with dupilumab, while 2,010 started with methotrexate, 536 started with mycophenolate, and 429 started with cyclosporine. Using a new-user, active-comparator study design, the researchers identified patients with AD from both databases and selected three dupilumab cohorts: dupilumab versus methotrexate (MTX), dupilumab versus mycophenolate (MMF), and dupilumab versus cyclosporine (CsA). Follow-up lasted 6 months and 1:1 propensity score matching was used to account for conjunctivitis risk factor differences. Patients with a history of conjunctivitis were excluded from the study, except one subgroup limited to those with prior conjunctivitis.

Dr. Schneeweiss reported that the overall incidence rate of conjunctivitis within 6 months of treatment initiation was 6.6% in dupilumab users, or 1 in 15 patients, compared with 3.3% in MTX users, 4.2% in MMF users, and 2.8% in CsA users. The incidence rates for the different types of conjunctivitis were as follows:

• Bacterial conjunctivitis: 1.5% in dupilumab users versus 0.95% in MTX, 0.4% in MMF, and 0.7% in CsA users.
• Allergic conjunctivitis: 2.2% in dupilumab users versus 0.8% in MTX, 0.2% in MMF, and 1.6% in CsA users.
• Keratoconjunctivitis: 0.8% in dupilumab users versus 1.1% in MTX, 1.5% in MMF, and 0.5% in CsA users.

In addition, the rate of conjunctivitis requiring ophthalmic medication was 2.6% in dupilumab users versus 0.7% in MTX, 1% in MMF, and 0.5% in CsA users.

After the researchers applied 1:1 propensity score matching, they observed that the risk of conjunctivitis within 6 months of starting treatment was increased in dupilumab users versus MTX users (relative risk, 2.12), dupilumab versus MMF users (RR, 2.43), and dupilumab versus CsA users (RR, 1.83). Among dupilumab users, the risk of conjunctivitis requiring ophthalmic medication was increased six to eightfold, compared with those who used MTX, MMF or CsA. In addition, bacterial conjunctivitis was increased 1.6- to 4.0-fold, compared with those who used MTX, MMF or CsA, but the confidence intervals were wide and included the null, while allergic conjunctivitis was increased 2.7- to 7-fold when compared with those who used MTX and MMF.

In other findings, the risk of allergic conjunctivitis was similar between dupilumab and CsA users (RR, 1.14), and there was no increased risk of keratoconjunctivitis in dupilumab users, compared with those who used MTX, MMF, or CsA. The relative risk of conjunctivitis in those who used dupilumab was further increased when the analysis was limited to AD patients with comorbid asthma (RR, 2.86), those who used systemic glucocorticoids fewer than 30 days prior (RR, 2.88), and those age 65 and older (RR, 2.57), compared with those who used methotrexate.

“Compared to AD patients who received treatment with other systemic agents, dupilumab treatment doubled the risk of conjunctivitis in clinical practice,” Dr. Schneeweiss concluded. “Risk factors that further increase the risk include comorbid asthma, use of systemic corticosteroids, and older age. It should be noted that conjunctivitis does not require treatment discontinuation and is manageable with ophthalmic medications.”

Lawrence J. Green, MD, clinical professor of dermatology at George Washington University, Washington, who was asked to comment on the study, said that the work “verifies what we see clinically: that conjunctivitis is increased among dupilumab users even when it is compared to immunosuppressive agents used to treat other conditions. Because the study is retrospective, one cannot assume all diagnosis of types of conjunctivitis or even of skin disease is entirely accurate. But, with the large numbers of claims looked at and compared, one would think its conclusions are accurate.”

Dr. Schneeweiss reported having no relevant financial disclosures. Dr. Green disclosed that he is a speaker, consultant, or investigator for Amgen, AbbVie, Arcutis, Brickell, Candescent, Cassiopeia, Dermavant, Galderma, Janssen, Forte, Incyte, MC-2, Lilly, Novartis, Novan, Ortho Dermatologics, Revance, Sun Pharma, UCB, and Vyne.

[email protected]

One in 15 patients who start dupilumab treatment may develop conjunctivitis during the first 6 months, most of which is manageable with ophthalmic treatments, results from large study of U.S. claims data showed.

“About 4 years after dupilumab’s approval, we’re interested in how conjunctivitis has played out in our daily clinical practice,” lead study investigator Maria C. Schneeweiss, MD, said during the Revolutionizing Atopic Dermatitis symposium.

Drawing from two nationwide U.S. databases, MarketScan and Optum, Dr. Schneeweiss, of the department of dermatology at Brigham and Women’s Hospital, Boston, and colleagues sought to characterize the incidence of bacterial and nonbacterial conjunctivitis among 6,730 patients with AD who started treatment with either dupilumab, methotrexate, mycophenolate, or cyclosporine between March 2017 and January 2020. They also wanted to identify patient subgroups at increased or decreased risk of dupilumab-related conjunctivitis in clinical practice.

Of the 6,730 patients, 3,755 started treatment with dupilumab, while 2,010 started with methotrexate, 536 started with mycophenolate, and 429 started with cyclosporine. Using a new-user, active-comparator study design, the researchers identified patients with AD from both databases and selected three dupilumab cohorts: dupilumab versus methotrexate (MTX), dupilumab versus mycophenolate (MMF), and dupilumab versus cyclosporine (CsA). Follow-up lasted 6 months and 1:1 propensity score matching was used to account for conjunctivitis risk factor differences. Patients with a history of conjunctivitis were excluded from the study, except one subgroup limited to those with prior conjunctivitis.

Dr. Schneeweiss reported that the overall incidence rate of conjunctivitis within 6 months of treatment initiation was 6.6% in dupilumab users, or 1 in 15 patients, compared with 3.3% in MTX users, 4.2% in MMF users, and 2.8% in CsA users. The incidence rates for the different types of conjunctivitis were as follows:

• Bacterial conjunctivitis: 1.5% in dupilumab users versus 0.95% in MTX, 0.4% in MMF, and 0.7% in CsA users.
• Allergic conjunctivitis: 2.2% in dupilumab users versus 0.8% in MTX, 0.2% in MMF, and 1.6% in CsA users.
• Keratoconjunctivitis: 0.8% in dupilumab users versus 1.1% in MTX, 1.5% in MMF, and 0.5% in CsA users.

In addition, the rate of conjunctivitis requiring ophthalmic medication was 2.6% in dupilumab users versus 0.7% in MTX, 1% in MMF, and 0.5% in CsA users.

After the researchers applied 1:1 propensity score matching, they observed that the risk of conjunctivitis within 6 months of starting treatment was increased in dupilumab users versus MTX users (relative risk, 2.12), dupilumab versus MMF users (RR, 2.43), and dupilumab versus CsA users (RR, 1.83). Among dupilumab users, the risk of conjunctivitis requiring ophthalmic medication was increased six to eightfold, compared with those who used MTX, MMF or CsA. In addition, bacterial conjunctivitis was increased 1.6- to 4.0-fold, compared with those who used MTX, MMF or CsA, but the confidence intervals were wide and included the null, while allergic conjunctivitis was increased 2.7- to 7-fold when compared with those who used MTX and MMF.

In other findings, the risk of allergic conjunctivitis was similar between dupilumab and CsA users (RR, 1.14), and there was no increased risk of keratoconjunctivitis in dupilumab users, compared with those who used MTX, MMF, or CsA. The relative risk of conjunctivitis in those who used dupilumab was further increased when the analysis was limited to AD patients with comorbid asthma (RR, 2.86), those who used systemic glucocorticoids fewer than 30 days prior (RR, 2.88), and those age 65 and older (RR, 2.57), compared with those who used methotrexate.

“Compared to AD patients who received treatment with other systemic agents, dupilumab treatment doubled the risk of conjunctivitis in clinical practice,” Dr. Schneeweiss concluded. “Risk factors that further increase the risk include comorbid asthma, use of systemic corticosteroids, and older age. It should be noted that conjunctivitis does not require treatment discontinuation and is manageable with ophthalmic medications.”

Lawrence J. Green, MD, clinical professor of dermatology at George Washington University, Washington, who was asked to comment on the study, said that the work “verifies what we see clinically: that conjunctivitis is increased among dupilumab users even when it is compared to immunosuppressive agents used to treat other conditions. Because the study is retrospective, one cannot assume all diagnosis of types of conjunctivitis or even of skin disease is entirely accurate. But, with the large numbers of claims looked at and compared, one would think its conclusions are accurate.”

Dr. Schneeweiss reported having no relevant financial disclosures. Dr. Green disclosed that he is a speaker, consultant, or investigator for Amgen, AbbVie, Arcutis, Brickell, Candescent, Cassiopeia, Dermavant, Galderma, Janssen, Forte, Incyte, MC-2, Lilly, Novartis, Novan, Ortho Dermatologics, Revance, Sun Pharma, UCB, and Vyne.

[email protected]

One in 15 patients who start dupilumab treatment may develop conjunctivitis during the first 6 months, most of which is manageable with ophthalmic treatments, results from large study of U.S. claims data showed.

“About 4 years after dupilumab’s approval, we’re interested in how conjunctivitis has played out in our daily clinical practice,” lead study investigator Maria C. Schneeweiss, MD, said during the Revolutionizing Atopic Dermatitis symposium.

Drawing from two nationwide U.S. databases, MarketScan and Optum, Dr. Schneeweiss, of the department of dermatology at Brigham and Women’s Hospital, Boston, and colleagues sought to characterize the incidence of bacterial and nonbacterial conjunctivitis among 6,730 patients with AD who started treatment with either dupilumab, methotrexate, mycophenolate, or cyclosporine between March 2017 and January 2020. They also wanted to identify patient subgroups at increased or decreased risk of dupilumab-related conjunctivitis in clinical practice.

Of the 6,730 patients, 3,755 started treatment with dupilumab, while 2,010 started with methotrexate, 536 started with mycophenolate, and 429 started with cyclosporine. Using a new-user, active-comparator study design, the researchers identified patients with AD from both databases and selected three dupilumab cohorts: dupilumab versus methotrexate (MTX), dupilumab versus mycophenolate (MMF), and dupilumab versus cyclosporine (CsA). Follow-up lasted 6 months and 1:1 propensity score matching was used to account for conjunctivitis risk factor differences. Patients with a history of conjunctivitis were excluded from the study, except one subgroup limited to those with prior conjunctivitis.

Dr. Schneeweiss reported that the overall incidence rate of conjunctivitis within 6 months of treatment initiation was 6.6% in dupilumab users, or 1 in 15 patients, compared with 3.3% in MTX users, 4.2% in MMF users, and 2.8% in CsA users. The incidence rates for the different types of conjunctivitis were as follows:

• Bacterial conjunctivitis: 1.5% in dupilumab users versus 0.95% in MTX, 0.4% in MMF, and 0.7% in CsA users.
• Allergic conjunctivitis: 2.2% in dupilumab users versus 0.8% in MTX, 0.2% in MMF, and 1.6% in CsA users.
• Keratoconjunctivitis: 0.8% in dupilumab users versus 1.1% in MTX, 1.5% in MMF, and 0.5% in CsA users.

In addition, the rate of conjunctivitis requiring ophthalmic medication was 2.6% in dupilumab users versus 0.7% in MTX, 1% in MMF, and 0.5% in CsA users.

After the researchers applied 1:1 propensity score matching, they observed that the risk of conjunctivitis within 6 months of starting treatment was increased in dupilumab users versus MTX users (relative risk, 2.12), dupilumab versus MMF users (RR, 2.43), and dupilumab versus CsA users (RR, 1.83). Among dupilumab users, the risk of conjunctivitis requiring ophthalmic medication was increased six to eightfold, compared with those who used MTX, MMF or CsA. In addition, bacterial conjunctivitis was increased 1.6- to 4.0-fold, compared with those who used MTX, MMF or CsA, but the confidence intervals were wide and included the null, while allergic conjunctivitis was increased 2.7- to 7-fold when compared with those who used MTX and MMF.

In other findings, the risk of allergic conjunctivitis was similar between dupilumab and CsA users (RR, 1.14), and there was no increased risk of keratoconjunctivitis in dupilumab users, compared with those who used MTX, MMF, or CsA. The relative risk of conjunctivitis in those who used dupilumab was further increased when the analysis was limited to AD patients with comorbid asthma (RR, 2.86), those who used systemic glucocorticoids fewer than 30 days prior (RR, 2.88), and those age 65 and older (RR, 2.57), compared with those who used methotrexate.

“Compared to AD patients who received treatment with other systemic agents, dupilumab treatment doubled the risk of conjunctivitis in clinical practice,” Dr. Schneeweiss concluded. “Risk factors that further increase the risk include comorbid asthma, use of systemic corticosteroids, and older age. It should be noted that conjunctivitis does not require treatment discontinuation and is manageable with ophthalmic medications.”

Lawrence J. Green, MD, clinical professor of dermatology at George Washington University, Washington, who was asked to comment on the study, said that the work “verifies what we see clinically: that conjunctivitis is increased among dupilumab users even when it is compared to immunosuppressive agents used to treat other conditions. Because the study is retrospective, one cannot assume all diagnosis of types of conjunctivitis or even of skin disease is entirely accurate. But, with the large numbers of claims looked at and compared, one would think its conclusions are accurate.”

Dr. Schneeweiss reported having no relevant financial disclosures. Dr. Green disclosed that he is a speaker, consultant, or investigator for Amgen, AbbVie, Arcutis, Brickell, Candescent, Cassiopeia, Dermavant, Galderma, Janssen, Forte, Incyte, MC-2, Lilly, Novartis, Novan, Ortho Dermatologics, Revance, Sun Pharma, UCB, and Vyne.

[email protected]

Among the 51 patients with moderate to severe atopic dermatitis (AD) who developed COVID-19 while participating in an open-label clinical trial of tralokinumab, 96% of cases were mild or moderate and all patients continued tralokinumab treatment following their diagnosis.

“This is a great first look at COVID-19 outcomes in this population,” lead study investigator Andrew Blauvelt, MD, MBA, said during the Revolutionizing Atopic Dermatitis symposium. “This suggests that tralokinumab does not significantly impact the ability to respond to SARS-CoV-2, the virus that causes COVID-19. It’s encouraging and promising.”

Tralokinumab is a fully human IgG4 monoclonal antibody that specifically binds to interleukin-13, which is a key driver of underlying inflammation in AD. An ongoing, open-label extension trial called ECZTEND is investigating the long-term safety and efficacy of tralokinumab in patients with AD who participated in previous tralokinumab trials. The purpose of the current case series is to describe the outcomes of patients diagnosed with COVID-19 while participating in ECZTEND, which is a 5-year study.

“Patients are receiving tralokinumab 300 mg every 2 weeks,” said Dr. Blauvelt, a dermatologist who is president of Oregon Medical Research Center, Portland. “They’re allowed to use topical steroids, but they’re not allowed to use other AD treatments. We do regular clinical and safety assessments throughout the study.”

As of Feb. 26, 2021, there were 51 adults with moderate to severe AD who had confirmed COVID-19 infection during treatment with tralokinumab every 2 weeks. “Patients were not required to discontinue tralokinumab treatment following a COVID-19 diagnosis, if continuation was deemed appropriate by the investigator,” Dr. Blauvelt said. Of the 51 patients, 22 were male, 29 were female, their mean age was 38 years, and their baseline body mass index was 27.6 kg/m². Most of the patients (36, or 71%) were from Europe, 15 (29%) were from North America, and 30 (59%) had a history of asthma.

The average duration of COVID-19 infection was 15 days and severity of disease was mild in 35 patients (69%), moderate in 14 (27%), and severe in 2 (4%). According to the study abstract, those two patients had multiple risk factors and comorbidities, including obesity, chronic obstructive pulmonary disease, and cardiovascular disease. They were hospitalized for a mean of 7 days, but subsequently recovered – one with sequelae. None of the patients died.

Of the 51 COVID-19 cases, 2 were deemed to be possibly related to tralokinumab treatment by the investigator, Dr. Blauvelt said. Both were mild or moderate cases that occurred in patients younger than age 30. “Interestingly, 75% of the COVID-19 patients had no dose interruption; they continued dosing their tralokinumab every 2 weeks during and around the time they had COVID-19,” he said. “However, 25% of patients did interrupt their dosing during COVID-19 infection. That means that they either delayed or stopped dosing while they were sick.”

Of the 51 patients, 19 (37%) had received their first dose of the COVID-19 vaccine and 6 (12%) had received their second dose. “So, 12% of patients were fully vaccinated,” Dr. Blauvelt said. “We do know that the mRNA vaccines are about 95% effective in preventing COVID-19. Currently in Oregon, about 98% of our cases are in unvaccinated patients and about 2% of COVID-19 patients are fully vaccinated.”

In addition, the recently published ECZTRA5 vaccine study showed that nonlive vaccines (tetanus, diphtheria, and pertussis; and meningococcal vaccines) could be safely administered and can elicit normal immune responses in patients treated with tralokinumab.

“We sorely need COVID-19–related safety data for all of our current and emerging systemic and biologic therapies used to treat atopic dermatitis,” said Jonathan I. Silverberg, MD, PhD, MPH, director of clinical research in the division of dermatology at George Washington University, Washington, who was asked to comment about these results. “This study is important because it shows that tralokinumab was not associated with any obvious safety signals with respect to COVID-19 infections. The major limitation is that it is not a prospective study designed to assess tralokinumab efficacy in COVID-19 patients per se. However, this post hoc study provides reassuring data. We need similar or even more robust studies for other systemic therapies in AD.”

Dr. Blauvelt reported that he is an investigator and a scientific advisor for LEO Pharma, which is developing tralokinumab, and for several other pharmaceutical companies developing treatments for AD. Dr. Silverberg reported that he is a consultant to and/or an advisory board member for several pharmaceutical companies, including LEO Pharma.

[email protected]

Among the 51 patients with moderate to severe atopic dermatitis (AD) who developed COVID-19 while participating in an open-label clinical trial of tralokinumab, 96% of cases were mild or moderate and all patients continued tralokinumab treatment following their diagnosis.

“This is a great first look at COVID-19 outcomes in this population,” lead study investigator Andrew Blauvelt, MD, MBA, said during the Revolutionizing Atopic Dermatitis symposium. “This suggests that tralokinumab does not significantly impact the ability to respond to SARS-CoV-2, the virus that causes COVID-19. It’s encouraging and promising.”

Tralokinumab is a fully human IgG4 monoclonal antibody that specifically binds to interleukin-13, which is a key driver of underlying inflammation in AD. An ongoing, open-label extension trial called ECZTEND is investigating the long-term safety and efficacy of tralokinumab in patients with AD who participated in previous tralokinumab trials. The purpose of the current case series is to describe the outcomes of patients diagnosed with COVID-19 while participating in ECZTEND, which is a 5-year study.

“Patients are receiving tralokinumab 300 mg every 2 weeks,” said Dr. Blauvelt, a dermatologist who is president of Oregon Medical Research Center, Portland. “They’re allowed to use topical steroids, but they’re not allowed to use other AD treatments. We do regular clinical and safety assessments throughout the study.”

As of Feb. 26, 2021, there were 51 adults with moderate to severe AD who had confirmed COVID-19 infection during treatment with tralokinumab every 2 weeks. “Patients were not required to discontinue tralokinumab treatment following a COVID-19 diagnosis, if continuation was deemed appropriate by the investigator,” Dr. Blauvelt said. Of the 51 patients, 22 were male, 29 were female, their mean age was 38 years, and their baseline body mass index was 27.6 kg/m². Most of the patients (36, or 71%) were from Europe, 15 (29%) were from North America, and 30 (59%) had a history of asthma.

The average duration of COVID-19 infection was 15 days and severity of disease was mild in 35 patients (69%), moderate in 14 (27%), and severe in 2 (4%). According to the study abstract, those two patients had multiple risk factors and comorbidities, including obesity, chronic obstructive pulmonary disease, and cardiovascular disease. They were hospitalized for a mean of 7 days, but subsequently recovered – one with sequelae. None of the patients died.

Of the 51 COVID-19 cases, 2 were deemed to be possibly related to tralokinumab treatment by the investigator, Dr. Blauvelt said. Both were mild or moderate cases that occurred in patients younger than age 30. “Interestingly, 75% of the COVID-19 patients had no dose interruption; they continued dosing their tralokinumab every 2 weeks during and around the time they had COVID-19,” he said. “However, 25% of patients did interrupt their dosing during COVID-19 infection. That means that they either delayed or stopped dosing while they were sick.”

Of the 51 patients, 19 (37%) had received their first dose of the COVID-19 vaccine and 6 (12%) had received their second dose. “So, 12% of patients were fully vaccinated,” Dr. Blauvelt said. “We do know that the mRNA vaccines are about 95% effective in preventing COVID-19. Currently in Oregon, about 98% of our cases are in unvaccinated patients and about 2% of COVID-19 patients are fully vaccinated.”

In addition, the recently published ECZTRA5 vaccine study showed that nonlive vaccines (tetanus, diphtheria, and pertussis; and meningococcal vaccines) could be safely administered and can elicit normal immune responses in patients treated with tralokinumab.

“We sorely need COVID-19–related safety data for all of our current and emerging systemic and biologic therapies used to treat atopic dermatitis,” said Jonathan I. Silverberg, MD, PhD, MPH, director of clinical research in the division of dermatology at George Washington University, Washington, who was asked to comment about these results. “This study is important because it shows that tralokinumab was not associated with any obvious safety signals with respect to COVID-19 infections. The major limitation is that it is not a prospective study designed to assess tralokinumab efficacy in COVID-19 patients per se. However, this post hoc study provides reassuring data. We need similar or even more robust studies for other systemic therapies in AD.”

Dr. Blauvelt reported that he is an investigator and a scientific advisor for LEO Pharma, which is developing tralokinumab, and for several other pharmaceutical companies developing treatments for AD. Dr. Silverberg reported that he is a consultant to and/or an advisory board member for several pharmaceutical companies, including LEO Pharma.

[email protected]

Among the 51 patients with moderate to severe atopic dermatitis (AD) who developed COVID-19 while participating in an open-label clinical trial of tralokinumab, 96% of cases were mild or moderate and all patients continued tralokinumab treatment following their diagnosis.

“This is a great first look at COVID-19 outcomes in this population,” lead study investigator Andrew Blauvelt, MD, MBA, said during the Revolutionizing Atopic Dermatitis symposium. “This suggests that tralokinumab does not significantly impact the ability to respond to SARS-CoV-2, the virus that causes COVID-19. It’s encouraging and promising.”

Tralokinumab is a fully human IgG4 monoclonal antibody that specifically binds to interleukin-13, which is a key driver of underlying inflammation in AD. An ongoing, open-label extension trial called ECZTEND is investigating the long-term safety and efficacy of tralokinumab in patients with AD who participated in previous tralokinumab trials. The purpose of the current case series is to describe the outcomes of patients diagnosed with COVID-19 while participating in ECZTEND, which is a 5-year study.

“Patients are receiving tralokinumab 300 mg every 2 weeks,” said Dr. Blauvelt, a dermatologist who is president of Oregon Medical Research Center, Portland. “They’re allowed to use topical steroids, but they’re not allowed to use other AD treatments. We do regular clinical and safety assessments throughout the study.”

As of Feb. 26, 2021, there were 51 adults with moderate to severe AD who had confirmed COVID-19 infection during treatment with tralokinumab every 2 weeks. “Patients were not required to discontinue tralokinumab treatment following a COVID-19 diagnosis, if continuation was deemed appropriate by the investigator,” Dr. Blauvelt said. Of the 51 patients, 22 were male, 29 were female, their mean age was 38 years, and their baseline body mass index was 27.6 kg/m². Most of the patients (36, or 71%) were from Europe, 15 (29%) were from North America, and 30 (59%) had a history of asthma.

The average duration of COVID-19 infection was 15 days and severity of disease was mild in 35 patients (69%), moderate in 14 (27%), and severe in 2 (4%). According to the study abstract, those two patients had multiple risk factors and comorbidities, including obesity, chronic obstructive pulmonary disease, and cardiovascular disease. They were hospitalized for a mean of 7 days, but subsequently recovered – one with sequelae. None of the patients died.

Of the 51 COVID-19 cases, 2 were deemed to be possibly related to tralokinumab treatment by the investigator, Dr. Blauvelt said. Both were mild or moderate cases that occurred in patients younger than age 30. “Interestingly, 75% of the COVID-19 patients had no dose interruption; they continued dosing their tralokinumab every 2 weeks during and around the time they had COVID-19,” he said. “However, 25% of patients did interrupt their dosing during COVID-19 infection. That means that they either delayed or stopped dosing while they were sick.”

Of the 51 patients, 19 (37%) had received their first dose of the COVID-19 vaccine and 6 (12%) had received their second dose. “So, 12% of patients were fully vaccinated,” Dr. Blauvelt said. “We do know that the mRNA vaccines are about 95% effective in preventing COVID-19. Currently in Oregon, about 98% of our cases are in unvaccinated patients and about 2% of COVID-19 patients are fully vaccinated.”

In addition, the recently published ECZTRA5 vaccine study showed that nonlive vaccines (tetanus, diphtheria, and pertussis; and meningococcal vaccines) could be safely administered and can elicit normal immune responses in patients treated with tralokinumab.

“We sorely need COVID-19–related safety data for all of our current and emerging systemic and biologic therapies used to treat atopic dermatitis,” said Jonathan I. Silverberg, MD, PhD, MPH, director of clinical research in the division of dermatology at George Washington University, Washington, who was asked to comment about these results. “This study is important because it shows that tralokinumab was not associated with any obvious safety signals with respect to COVID-19 infections. The major limitation is that it is not a prospective study designed to assess tralokinumab efficacy in COVID-19 patients per se. However, this post hoc study provides reassuring data. We need similar or even more robust studies for other systemic therapies in AD.”

Dr. Blauvelt reported that he is an investigator and a scientific advisor for LEO Pharma, which is developing tralokinumab, and for several other pharmaceutical companies developing treatments for AD. Dr. Silverberg reported that he is a consultant to and/or an advisory board member for several pharmaceutical companies, including LEO Pharma.

[email protected]

The Americans with Disabilities Act (ADA) carries mandates most physician practices must follow to make their offices accessible so as to not discriminate against patients with disabilities when providing care. And 7 years ago, the government raised the penalties for failing to do so. So it might be time to re-educate yourself on what the ADA requires.

ADA compliance is not an issue that we talk about or provide training for in medical schools or with our professional organizations. Since fines for small businesses are now $75,000 for a first offense and $150,000 for each subsequent violation, this could be an expensive oversight that malpractice and other liability policies will not cover.

A 2019 study in Boston examined physicians’ knowledge of legal obligations when caring for patients with disabilities. Researchers concluded that most physicians interviewed “exhibited a superficial or incorrect understanding of their legal responsibilities to patients with a disability.” If you feel you’re in that boat, you might want to consult federal guidance with information and common questions physicians ask about their ADA obligations.

The ADA defines a person with a disability as someone with “a physical or mental impairment that substantially limits one or more life activities”; someone with a record of such an impairment; or someone who is “regarded as having such an impairment.” Among the ADA standards required for accessible exam rooms, according to the guidance:

• The entry door to the exam room should be a minimum width of 32 inches when the door is opened at a 90-degree angle.
• There should be a minimum of 30 by 48 inches of clear floor space next to the exam table.
• An accessible exam table should be able to be lowered to the height of the patient’s wheelchair seat, 17 to 19 inches from the floor.

This does not mean that all of your exam rooms must meet these standards, of course; but if you see any patients with disabilities – and who doesn’t? – you need at least one room that meets the criteria.

Federal guidance also includes requirements on removal of architectural barriers, accessible parking, and entrance and maneuvering spaces – which apply to both for-profit and nonprofit organizations. Among them:

• Designated accessible parking spaces must be included among any parking the business provides for the public “if doing so is readily achievable.” Those parking spaces should be the closest to the accessible entrance, on level ground. The spaces should be at least eight feet wide, with an access aisle on either side.
• For accessible spaces for cars, the adjacent access aisle must be at least five feet wide; for van spaces, eight feet wide.
• “If achievable,” an accessible service counter must have a maximum height of 36 inches, with a clear floor space of 30 by 48 inches to permit the use of a wheelchair.

A common misconception is that only new construction and alterations need to be accessible, and that older facilities are “grandfathered,” but that’s not true. Because the ADA is a civil rights law and not a building code, ADA rules apply equally to all facilities, young and old. This is particularly important to remember in light of the long-standing cottage industry of attorneys who sue small businesses for alleged ADA violations.

Another common mistake made by physicians who lease their office space is to assume that their landlord is responsible for meeting all ADA obligations. In fact, The ADA places the legal obligation on both the landlord and the tenant. The landlord and the tenant may decide among themselves who will actually make the changes and provide the aids and services, but both remain legally responsible.

Another aspect that you might not have thought of is access to your website. While ADA applicability to online services remains vague, lawsuits have been filed, and are likely to increase. Online accessibility issues that have been identified include:
 

• Ability to find and process information on a website (e.g., providing audio descriptions for video content, for the sight-impaired).
• Ability to navigate and use a website (e.g., ensuring that all site functions are easily accessible with only a keyboard).
• Ability to comprehend all information (including clearly understandable error messages).

Hearing-impaired patients present their own considerations for delivering adequate care, which I will discuss in my next column.
 

Dr. Eastern practices dermatology and dermatologic surgery in Belleville, N.J. He is the author of numerous articles and textbook chapters, and is a longtime monthly columnist for Dermatology News. Write to him at [email protected].

The Americans with Disabilities Act (ADA) carries mandates most physician practices must follow to make their offices accessible so as to not discriminate against patients with disabilities when providing care. And 7 years ago, the government raised the penalties for failing to do so. So it might be time to re-educate yourself on what the ADA requires.

ADA compliance is not an issue that we talk about or provide training for in medical schools or with our professional organizations. Since fines for small businesses are now $75,000 for a first offense and $150,000 for each subsequent violation, this could be an expensive oversight that malpractice and other liability policies will not cover.

A 2019 study in Boston examined physicians’ knowledge of legal obligations when caring for patients with disabilities. Researchers concluded that most physicians interviewed “exhibited a superficial or incorrect understanding of their legal responsibilities to patients with a disability.” If you feel you’re in that boat, you might want to consult federal guidance with information and common questions physicians ask about their ADA obligations.

The ADA defines a person with a disability as someone with “a physical or mental impairment that substantially limits one or more life activities”; someone with a record of such an impairment; or someone who is “regarded as having such an impairment.” Among the ADA standards required for accessible exam rooms, according to the guidance:

• The entry door to the exam room should be a minimum width of 32 inches when the door is opened at a 90-degree angle.
• There should be a minimum of 30 by 48 inches of clear floor space next to the exam table.
• An accessible exam table should be able to be lowered to the height of the patient’s wheelchair seat, 17 to 19 inches from the floor.

This does not mean that all of your exam rooms must meet these standards, of course; but if you see any patients with disabilities – and who doesn’t? – you need at least one room that meets the criteria.

Federal guidance also includes requirements on removal of architectural barriers, accessible parking, and entrance and maneuvering spaces – which apply to both for-profit and nonprofit organizations. Among them:

• Designated accessible parking spaces must be included among any parking the business provides for the public “if doing so is readily achievable.” Those parking spaces should be the closest to the accessible entrance, on level ground. The spaces should be at least eight feet wide, with an access aisle on either side.
• For accessible spaces for cars, the adjacent access aisle must be at least five feet wide; for van spaces, eight feet wide.
• “If achievable,” an accessible service counter must have a maximum height of 36 inches, with a clear floor space of 30 by 48 inches to permit the use of a wheelchair.

A common misconception is that only new construction and alterations need to be accessible, and that older facilities are “grandfathered,” but that’s not true. Because the ADA is a civil rights law and not a building code, ADA rules apply equally to all facilities, young and old. This is particularly important to remember in light of the long-standing cottage industry of attorneys who sue small businesses for alleged ADA violations.

Another common mistake made by physicians who lease their office space is to assume that their landlord is responsible for meeting all ADA obligations. In fact, The ADA places the legal obligation on both the landlord and the tenant. The landlord and the tenant may decide among themselves who will actually make the changes and provide the aids and services, but both remain legally responsible.

Another aspect that you might not have thought of is access to your website. While ADA applicability to online services remains vague, lawsuits have been filed, and are likely to increase. Online accessibility issues that have been identified include:
 

• Ability to find and process information on a website (e.g., providing audio descriptions for video content, for the sight-impaired).
• Ability to navigate and use a website (e.g., ensuring that all site functions are easily accessible with only a keyboard).
• Ability to comprehend all information (including clearly understandable error messages).

Hearing-impaired patients present their own considerations for delivering adequate care, which I will discuss in my next column.
 

Dr. Eastern practices dermatology and dermatologic surgery in Belleville, N.J. He is the author of numerous articles and textbook chapters, and is a longtime monthly columnist for Dermatology News. Write to him at [email protected].

The Americans with Disabilities Act (ADA) carries mandates most physician practices must follow to make their offices accessible so as to not discriminate against patients with disabilities when providing care. And 7 years ago, the government raised the penalties for failing to do so. So it might be time to re-educate yourself on what the ADA requires.

ADA compliance is not an issue that we talk about or provide training for in medical schools or with our professional organizations. Since fines for small businesses are now $75,000 for a first offense and $150,000 for each subsequent violation, this could be an expensive oversight that malpractice and other liability policies will not cover.

A 2019 study in Boston examined physicians’ knowledge of legal obligations when caring for patients with disabilities. Researchers concluded that most physicians interviewed “exhibited a superficial or incorrect understanding of their legal responsibilities to patients with a disability.” If you feel you’re in that boat, you might want to consult federal guidance with information and common questions physicians ask about their ADA obligations.

The ADA defines a person with a disability as someone with “a physical or mental impairment that substantially limits one or more life activities”; someone with a record of such an impairment; or someone who is “regarded as having such an impairment.” Among the ADA standards required for accessible exam rooms, according to the guidance:

• The entry door to the exam room should be a minimum width of 32 inches when the door is opened at a 90-degree angle.
• There should be a minimum of 30 by 48 inches of clear floor space next to the exam table.
• An accessible exam table should be able to be lowered to the height of the patient’s wheelchair seat, 17 to 19 inches from the floor.

This does not mean that all of your exam rooms must meet these standards, of course; but if you see any patients with disabilities – and who doesn’t? – you need at least one room that meets the criteria.

Federal guidance also includes requirements on removal of architectural barriers, accessible parking, and entrance and maneuvering spaces – which apply to both for-profit and nonprofit organizations. Among them:

• Designated accessible parking spaces must be included among any parking the business provides for the public “if doing so is readily achievable.” Those parking spaces should be the closest to the accessible entrance, on level ground. The spaces should be at least eight feet wide, with an access aisle on either side.
• For accessible spaces for cars, the adjacent access aisle must be at least five feet wide; for van spaces, eight feet wide.
• “If achievable,” an accessible service counter must have a maximum height of 36 inches, with a clear floor space of 30 by 48 inches to permit the use of a wheelchair.

A common misconception is that only new construction and alterations need to be accessible, and that older facilities are “grandfathered,” but that’s not true. Because the ADA is a civil rights law and not a building code, ADA rules apply equally to all facilities, young and old. This is particularly important to remember in light of the long-standing cottage industry of attorneys who sue small businesses for alleged ADA violations.

Another common mistake made by physicians who lease their office space is to assume that their landlord is responsible for meeting all ADA obligations. In fact, The ADA places the legal obligation on both the landlord and the tenant. The landlord and the tenant may decide among themselves who will actually make the changes and provide the aids and services, but both remain legally responsible.

Another aspect that you might not have thought of is access to your website. While ADA applicability to online services remains vague, lawsuits have been filed, and are likely to increase. Online accessibility issues that have been identified include:
 

• Ability to find and process information on a website (e.g., providing audio descriptions for video content, for the sight-impaired).
• Ability to navigate and use a website (e.g., ensuring that all site functions are easily accessible with only a keyboard).
• Ability to comprehend all information (including clearly understandable error messages).

Hearing-impaired patients present their own considerations for delivering adequate care, which I will discuss in my next column.
 

Dr. Eastern practices dermatology and dermatologic surgery in Belleville, N.J. He is the author of numerous articles and textbook chapters, and is a longtime monthly columnist for Dermatology News. Write to him at [email protected].