User login
FDA updates status of iPLEDGE access problems
The, one month after a modified program was launched, the Food and Drug Administration announced on Jan. 14.
The IPMG has “created a new tool within the system to help resolve account access for some user groups without using the call center. This tool is intended to allow prescribers and designees to send login links directly to their patients’ desired email address through the Manage Patients page of the iPLEDGE REMS portal,” the FDA statement said.
“Prescribers can also send login links to their designees still having difficulty accessing their iPLEDGE account,” and users should check their emails for messages from iPLEDGE, including spam folders, the FDA advises. The iPLEDGE strategy is designed to prevent fetal exposure to isotretinoin, which is highly teratogenic.
Days after the new, gender-neutral approach to the isotretinoin risk mitigation program was launched on Dec. 13, the FDA convened an emergency meeting with representatives from the American Academy of Dermatology Association (AADA) to discuss the problematic rollout of the program, which was described as disastrous, chaotic, and a failure, with dermatologists on Twitter and elsewhere expressing anger and frustration over not being able to access the program or reach the call center.
A statement by the FDA on Dec. 23 followed, urging manufacturers to develop solutions for the website and to work with the AADA and pharmacy organizations to find solutions that would minimize treatment interruptions during the transition.
The modified REMS, launched on Dec. 13, is designed to make it more inclusive for transgender patients prescribed isotretinoin. Instead of three risk categories (females of reproductive potential, females not of reproductive potential, and males), patients who are prescribed isotretinoin for acne are assigned to one of two risk categories: those who can get pregnant and those who cannot get pregnant.
In the Jan. 14 statement, the FDA notes that the agency is continuing to work with the IPMG regarding the problems clinicians, pharmacists, and patients have had with accessing iPLEDGE over the last month.
“Although there has been progress, there is a significant amount of work still to be done,” the FDA acknowledged. “While we consider potential steps within the scope of FDA’s authorities, we will continue to meet with the IPMG for updates on the status of the problems with the iPLEDGE REMS and their progress towards having the system work as intended for all users.”
The, one month after a modified program was launched, the Food and Drug Administration announced on Jan. 14.
The IPMG has “created a new tool within the system to help resolve account access for some user groups without using the call center. This tool is intended to allow prescribers and designees to send login links directly to their patients’ desired email address through the Manage Patients page of the iPLEDGE REMS portal,” the FDA statement said.
“Prescribers can also send login links to their designees still having difficulty accessing their iPLEDGE account,” and users should check their emails for messages from iPLEDGE, including spam folders, the FDA advises. The iPLEDGE strategy is designed to prevent fetal exposure to isotretinoin, which is highly teratogenic.
Days after the new, gender-neutral approach to the isotretinoin risk mitigation program was launched on Dec. 13, the FDA convened an emergency meeting with representatives from the American Academy of Dermatology Association (AADA) to discuss the problematic rollout of the program, which was described as disastrous, chaotic, and a failure, with dermatologists on Twitter and elsewhere expressing anger and frustration over not being able to access the program or reach the call center.
A statement by the FDA on Dec. 23 followed, urging manufacturers to develop solutions for the website and to work with the AADA and pharmacy organizations to find solutions that would minimize treatment interruptions during the transition.
The modified REMS, launched on Dec. 13, is designed to make it more inclusive for transgender patients prescribed isotretinoin. Instead of three risk categories (females of reproductive potential, females not of reproductive potential, and males), patients who are prescribed isotretinoin for acne are assigned to one of two risk categories: those who can get pregnant and those who cannot get pregnant.
In the Jan. 14 statement, the FDA notes that the agency is continuing to work with the IPMG regarding the problems clinicians, pharmacists, and patients have had with accessing iPLEDGE over the last month.
“Although there has been progress, there is a significant amount of work still to be done,” the FDA acknowledged. “While we consider potential steps within the scope of FDA’s authorities, we will continue to meet with the IPMG for updates on the status of the problems with the iPLEDGE REMS and their progress towards having the system work as intended for all users.”
The, one month after a modified program was launched, the Food and Drug Administration announced on Jan. 14.
The IPMG has “created a new tool within the system to help resolve account access for some user groups without using the call center. This tool is intended to allow prescribers and designees to send login links directly to their patients’ desired email address through the Manage Patients page of the iPLEDGE REMS portal,” the FDA statement said.
“Prescribers can also send login links to their designees still having difficulty accessing their iPLEDGE account,” and users should check their emails for messages from iPLEDGE, including spam folders, the FDA advises. The iPLEDGE strategy is designed to prevent fetal exposure to isotretinoin, which is highly teratogenic.
Days after the new, gender-neutral approach to the isotretinoin risk mitigation program was launched on Dec. 13, the FDA convened an emergency meeting with representatives from the American Academy of Dermatology Association (AADA) to discuss the problematic rollout of the program, which was described as disastrous, chaotic, and a failure, with dermatologists on Twitter and elsewhere expressing anger and frustration over not being able to access the program or reach the call center.
A statement by the FDA on Dec. 23 followed, urging manufacturers to develop solutions for the website and to work with the AADA and pharmacy organizations to find solutions that would minimize treatment interruptions during the transition.
The modified REMS, launched on Dec. 13, is designed to make it more inclusive for transgender patients prescribed isotretinoin. Instead of three risk categories (females of reproductive potential, females not of reproductive potential, and males), patients who are prescribed isotretinoin for acne are assigned to one of two risk categories: those who can get pregnant and those who cannot get pregnant.
In the Jan. 14 statement, the FDA notes that the agency is continuing to work with the IPMG regarding the problems clinicians, pharmacists, and patients have had with accessing iPLEDGE over the last month.
“Although there has been progress, there is a significant amount of work still to be done,” the FDA acknowledged. “While we consider potential steps within the scope of FDA’s authorities, we will continue to meet with the IPMG for updates on the status of the problems with the iPLEDGE REMS and their progress towards having the system work as intended for all users.”
75-year-old White male presenting with progressive pruritus and a worsening rash
, although it can also be contracted through contaminated bedding and clothing. It can affect all races and ages.
Patients typically present with extremely pruritic, symmetric papules and excoriations. In nodular scabies, nodules and large papules are seen on exam. Thin lines in the skin called burrows may be present, especially in the webs between fingers. Female mites create burrows as they tunnel through the epidermis and lay eggs. The wrists, areola, waistline, and groin may all be involved, creating an imaginary circle between the areas described as the “circle of Hebra.” Penile and scrotal lesions are common in men.
Patients usually experience worse pruritus at night, which disturbs sleep. Crusted scabies is a severe form of scabies more often seen in those with immunocompromised immune systems. Clinically, thick crusted and scaly patches are present that are teeming with mites.
Diagnosis can be confirmed by performing a scabies prep, during which a burrow is scraped with a surgical blade. A drop of mineral oil is placed on the skin cells. The mite, ova, and feces can be visualized under the microscope. Wrists and hands usually have the highest yield for finding the parasites.
Topical treatments include permethrin 5% cream, lindane, benzyl benzoate, and crotamiton, and should be applied as two treatments a week apart. In the United States, permethrin is most commonly used. Ivermectin pills are used off label and are very effective and may be repeated for 1-2 weeks. All household contacts should be treated. Patients may still have pruritus for 2-4 weeks following treatment.
In this patient, a scabies prep was performed prior to performing repeat skin biopsies. Microscopic examination revealed ova, one mite, and feces. Treatment was initiated with ivermectin and permethrin.
Photos and case were submitted by Susannah Berke, MD, and Damon McClain, MD, Three Rivers Dermatology, Coraopolis, Pa.; and Dr. Bilu Martin.
Dr. Bilu Martin is a board-certified dermatologist in private practice at Premier Dermatology, MD, in Aventura, Fla. More diagnostic cases are available at mdedge.com/dermatology. To submit a case for possible publication, send an email to dermnews@mdedge.com.
, although it can also be contracted through contaminated bedding and clothing. It can affect all races and ages.
Patients typically present with extremely pruritic, symmetric papules and excoriations. In nodular scabies, nodules and large papules are seen on exam. Thin lines in the skin called burrows may be present, especially in the webs between fingers. Female mites create burrows as they tunnel through the epidermis and lay eggs. The wrists, areola, waistline, and groin may all be involved, creating an imaginary circle between the areas described as the “circle of Hebra.” Penile and scrotal lesions are common in men.
Patients usually experience worse pruritus at night, which disturbs sleep. Crusted scabies is a severe form of scabies more often seen in those with immunocompromised immune systems. Clinically, thick crusted and scaly patches are present that are teeming with mites.
Diagnosis can be confirmed by performing a scabies prep, during which a burrow is scraped with a surgical blade. A drop of mineral oil is placed on the skin cells. The mite, ova, and feces can be visualized under the microscope. Wrists and hands usually have the highest yield for finding the parasites.
Topical treatments include permethrin 5% cream, lindane, benzyl benzoate, and crotamiton, and should be applied as two treatments a week apart. In the United States, permethrin is most commonly used. Ivermectin pills are used off label and are very effective and may be repeated for 1-2 weeks. All household contacts should be treated. Patients may still have pruritus for 2-4 weeks following treatment.
In this patient, a scabies prep was performed prior to performing repeat skin biopsies. Microscopic examination revealed ova, one mite, and feces. Treatment was initiated with ivermectin and permethrin.
Photos and case were submitted by Susannah Berke, MD, and Damon McClain, MD, Three Rivers Dermatology, Coraopolis, Pa.; and Dr. Bilu Martin.
Dr. Bilu Martin is a board-certified dermatologist in private practice at Premier Dermatology, MD, in Aventura, Fla. More diagnostic cases are available at mdedge.com/dermatology. To submit a case for possible publication, send an email to dermnews@mdedge.com.
, although it can also be contracted through contaminated bedding and clothing. It can affect all races and ages.
Patients typically present with extremely pruritic, symmetric papules and excoriations. In nodular scabies, nodules and large papules are seen on exam. Thin lines in the skin called burrows may be present, especially in the webs between fingers. Female mites create burrows as they tunnel through the epidermis and lay eggs. The wrists, areola, waistline, and groin may all be involved, creating an imaginary circle between the areas described as the “circle of Hebra.” Penile and scrotal lesions are common in men.
Patients usually experience worse pruritus at night, which disturbs sleep. Crusted scabies is a severe form of scabies more often seen in those with immunocompromised immune systems. Clinically, thick crusted and scaly patches are present that are teeming with mites.
Diagnosis can be confirmed by performing a scabies prep, during which a burrow is scraped with a surgical blade. A drop of mineral oil is placed on the skin cells. The mite, ova, and feces can be visualized under the microscope. Wrists and hands usually have the highest yield for finding the parasites.
Topical treatments include permethrin 5% cream, lindane, benzyl benzoate, and crotamiton, and should be applied as two treatments a week apart. In the United States, permethrin is most commonly used. Ivermectin pills are used off label and are very effective and may be repeated for 1-2 weeks. All household contacts should be treated. Patients may still have pruritus for 2-4 weeks following treatment.
In this patient, a scabies prep was performed prior to performing repeat skin biopsies. Microscopic examination revealed ova, one mite, and feces. Treatment was initiated with ivermectin and permethrin.
Photos and case were submitted by Susannah Berke, MD, and Damon McClain, MD, Three Rivers Dermatology, Coraopolis, Pa.; and Dr. Bilu Martin.
Dr. Bilu Martin is a board-certified dermatologist in private practice at Premier Dermatology, MD, in Aventura, Fla. More diagnostic cases are available at mdedge.com/dermatology. To submit a case for possible publication, send an email to dermnews@mdedge.com.
Sometimes You Can’t Blame the Sun
ANSWER
The correct answer is all of the above (choice “e”).
DISCUSSION
Most cases of dermatomyositis, which the patient’s presentation and lab results suggested, require nerve conduction studies, a check of serum aldolase levels, and skin and muscle biopsies to complete the work-up. However, the arrival at a diagnosis is only the first step.
Patients with dermatomyositis, particularly those older than 60, require evaluation for occult malignancy. There is evidence that the body’s immune response to the cancer is what drives the disease process. Hence the need for the studies listed, looking for breast, lung, and gastrointestinal cancers especially.
Dermatomyositis is thought to be an inflammatory myopathy, possibly driven by autoimmune factors. It is rare (about 1 to 22 per 100,000) and affects women more than men.
The “sunburn” rash is typical, especially on the face, chest, and dorsal hands, and usually clears completely when the cancer is found and cured. Other common findings include elevated creatine kinase, hand rashes (known as Gottron’s papules), and dystrophic calcification in skin and/or joints.
TREATMENT
Aside from addressing a possible malignancy, treatment of dermatomyositis usually starts with glucocorticoids, eventually tapered and replaced by steroid-sparing agents such as azathioprine or cyclosporine. These drugs have dramatically increased the chances of survival and eventual cure.
It’s common for the photosensitivity to persist long after the myositis has resolved, which is why sunscreen and other sun-protective measures are advised.
ANSWER
The correct answer is all of the above (choice “e”).
DISCUSSION
Most cases of dermatomyositis, which the patient’s presentation and lab results suggested, require nerve conduction studies, a check of serum aldolase levels, and skin and muscle biopsies to complete the work-up. However, the arrival at a diagnosis is only the first step.
Patients with dermatomyositis, particularly those older than 60, require evaluation for occult malignancy. There is evidence that the body’s immune response to the cancer is what drives the disease process. Hence the need for the studies listed, looking for breast, lung, and gastrointestinal cancers especially.
Dermatomyositis is thought to be an inflammatory myopathy, possibly driven by autoimmune factors. It is rare (about 1 to 22 per 100,000) and affects women more than men.
The “sunburn” rash is typical, especially on the face, chest, and dorsal hands, and usually clears completely when the cancer is found and cured. Other common findings include elevated creatine kinase, hand rashes (known as Gottron’s papules), and dystrophic calcification in skin and/or joints.
TREATMENT
Aside from addressing a possible malignancy, treatment of dermatomyositis usually starts with glucocorticoids, eventually tapered and replaced by steroid-sparing agents such as azathioprine or cyclosporine. These drugs have dramatically increased the chances of survival and eventual cure.
It’s common for the photosensitivity to persist long after the myositis has resolved, which is why sunscreen and other sun-protective measures are advised.
ANSWER
The correct answer is all of the above (choice “e”).
DISCUSSION
Most cases of dermatomyositis, which the patient’s presentation and lab results suggested, require nerve conduction studies, a check of serum aldolase levels, and skin and muscle biopsies to complete the work-up. However, the arrival at a diagnosis is only the first step.
Patients with dermatomyositis, particularly those older than 60, require evaluation for occult malignancy. There is evidence that the body’s immune response to the cancer is what drives the disease process. Hence the need for the studies listed, looking for breast, lung, and gastrointestinal cancers especially.
Dermatomyositis is thought to be an inflammatory myopathy, possibly driven by autoimmune factors. It is rare (about 1 to 22 per 100,000) and affects women more than men.
The “sunburn” rash is typical, especially on the face, chest, and dorsal hands, and usually clears completely when the cancer is found and cured. Other common findings include elevated creatine kinase, hand rashes (known as Gottron’s papules), and dystrophic calcification in skin and/or joints.
TREATMENT
Aside from addressing a possible malignancy, treatment of dermatomyositis usually starts with glucocorticoids, eventually tapered and replaced by steroid-sparing agents such as azathioprine or cyclosporine. These drugs have dramatically increased the chances of survival and eventual cure.
It’s common for the photosensitivity to persist long after the myositis has resolved, which is why sunscreen and other sun-protective measures are advised.
A 60-year-old woman was referred to dermatology for evaluation of “sunburn.” The rash was painful and unrelieved by topical medications, including class IV steroid creams. The redness was tender and warm to touch.
The rash had been present for months. During this period, the patient also had grown increasingly weak, leading her to quit her job. In the clinic, she was unable to stand from a seated position without difficulty. She reported no other health concerns and had quit smoking 5 years previously, after 30 years.
On examination, diffuse blanchable macular erythema on the patient’s face and chest was immediately observed. There was also an odd rash, composed of hundreds of tiny confluent papules, concentrated over the interphalangeal joints and dorsal hands. These too were warm and tender to touch. Most of her cuticles were peeling off; closer examination under magnification revealed tortuous capillaries on the distal cuticles of several fingers.
Bloodwork revealed a creatine kinase level slightly greater than 1000 U/L, and a positive antinuclear antibody, dilution unknown.
Hand eczema and atopic dermatitis closely linked
An estimated (AD), according to Jacob P. Thyssen, MD, PhD.
“If we look at individuals with AD, the lifetime prevalence of hand eczema reaches 50%, so we see a strong association between hand eczema and AD,” Dr. Thyssen, professor of dermatology at the University of Copenhagen, said at the Revolutionizing Atopic Dermatitis symposium.
Risk factors for hand eczema – defined as eczema on the hand and/or wrists – include AD, which increases the risk by two- to threefold, as well as genetic predisposition beyond AD, exposure to irritants and allergens, female gender, young age, low socioeconomic group, high risk occupations (including construction workers and hairdressers), and tobacco smoking.
“As clinicians, we sometimes need to rule out a few differentials, including psoriasis and T-cell lymphoma. As an example, 10% of T-cell lymphoma patients, a very rare condition, have first onset of the disease on their hands,” Dr. Thyssen said. “Once we see persistent hand eczema, we need to obtain a history of irritant exposure and allergen exposure, both at home and at work, perform a patch test, sometimes a skin prick test, and ask about personal and family history of AD and psoriasis.”
He noted that while formal classification of hand eczema has been a struggle for decades, he favors the “straightforward” clinical approach from the European Environmental and Contact Dermatitis Research Group. Atopic hand eczema, he said, “is very much characterized by dorsal involvement of the hands and fingers and sparse involvement of the palmar aspects of the hands.”
The cheeks and hands are predilection sites for AD in filaggrin mutation carriers (as they are sites of low filaggrin levels), and sometimes harsh environmental exposures, such as cold and dry air. In a study of 3,335 patients in Denmark, Dr. Thyssen and colleagues found that filaggrin mutations and AD were associated with early-onset and persistent hand eczema. In another study of 3,834 adults with AD or psoriasis, he and colleagues found that among those with AD, the wrists, back of the hands, and interdigital areas were often sites of severe eczema, while palmar involvement was more uncommon.
The same findings apply for the feet in filaggrin mutation carriers with AD; the dorsal aspect of the feet was more commonly affected, compared with plantar aspects of the feet.
Medical literature regarding foot eczema is scarce, but a retrospective cohort study from Germany found that foot eczema and hand eczema often co-occur. Among 723 hand eczema patients, 201 (28%) had concomitant foot eczema. The same morphological features were found on the hands and feet in 71% of patients. Foot eczema was significantly associated with male sex, atopic hand eczema, hyperhidrosis, wearing of safety shoes/boots at work, and tobacco smoking.
In addition, a systematic review and meta-analysis of studies of hand eczema and AD found that there was a 4.29-fold increased risk of hand eczema in individuals with AD, and the risk (lifetime prevalence) of occupational hand eczema was increased by more than twofold. “However, this study could not differentiate between irritant contact dermatitis on the hands and atopic dermatitis,” Dr. Thyssen said. “The studies were not accurate enough to allow for any conclusions.”
A multicenter study of adults with hand eczema in Italy found that the proportion of patients with AD was the highest among those with severe and refractory chronic hand eczema. In addition, certain professions, including those of hairdressers, health professionals, and those in trade work, such as plumbing, were more often associated with chronic hand eczema. “This teaches us that we should be very careful about steering these patients from at-risk occupations,” Dr. Thyssen said. “Also, we should remember to treat them aggressively in the beginning to reduce the risk of severe and refractory chronic hand eczema.”
Dr. Thyssen disclosed that he is a speaker, advisory board member, and/or investigator for Asian, Arena, Almirall, AbbVie, Eli Lilly, LEO Pharma, Pfizer, Regeneron, and Sanofi Genzyme.
An estimated (AD), according to Jacob P. Thyssen, MD, PhD.
“If we look at individuals with AD, the lifetime prevalence of hand eczema reaches 50%, so we see a strong association between hand eczema and AD,” Dr. Thyssen, professor of dermatology at the University of Copenhagen, said at the Revolutionizing Atopic Dermatitis symposium.
Risk factors for hand eczema – defined as eczema on the hand and/or wrists – include AD, which increases the risk by two- to threefold, as well as genetic predisposition beyond AD, exposure to irritants and allergens, female gender, young age, low socioeconomic group, high risk occupations (including construction workers and hairdressers), and tobacco smoking.
“As clinicians, we sometimes need to rule out a few differentials, including psoriasis and T-cell lymphoma. As an example, 10% of T-cell lymphoma patients, a very rare condition, have first onset of the disease on their hands,” Dr. Thyssen said. “Once we see persistent hand eczema, we need to obtain a history of irritant exposure and allergen exposure, both at home and at work, perform a patch test, sometimes a skin prick test, and ask about personal and family history of AD and psoriasis.”
He noted that while formal classification of hand eczema has been a struggle for decades, he favors the “straightforward” clinical approach from the European Environmental and Contact Dermatitis Research Group. Atopic hand eczema, he said, “is very much characterized by dorsal involvement of the hands and fingers and sparse involvement of the palmar aspects of the hands.”
The cheeks and hands are predilection sites for AD in filaggrin mutation carriers (as they are sites of low filaggrin levels), and sometimes harsh environmental exposures, such as cold and dry air. In a study of 3,335 patients in Denmark, Dr. Thyssen and colleagues found that filaggrin mutations and AD were associated with early-onset and persistent hand eczema. In another study of 3,834 adults with AD or psoriasis, he and colleagues found that among those with AD, the wrists, back of the hands, and interdigital areas were often sites of severe eczema, while palmar involvement was more uncommon.
The same findings apply for the feet in filaggrin mutation carriers with AD; the dorsal aspect of the feet was more commonly affected, compared with plantar aspects of the feet.
Medical literature regarding foot eczema is scarce, but a retrospective cohort study from Germany found that foot eczema and hand eczema often co-occur. Among 723 hand eczema patients, 201 (28%) had concomitant foot eczema. The same morphological features were found on the hands and feet in 71% of patients. Foot eczema was significantly associated with male sex, atopic hand eczema, hyperhidrosis, wearing of safety shoes/boots at work, and tobacco smoking.
In addition, a systematic review and meta-analysis of studies of hand eczema and AD found that there was a 4.29-fold increased risk of hand eczema in individuals with AD, and the risk (lifetime prevalence) of occupational hand eczema was increased by more than twofold. “However, this study could not differentiate between irritant contact dermatitis on the hands and atopic dermatitis,” Dr. Thyssen said. “The studies were not accurate enough to allow for any conclusions.”
A multicenter study of adults with hand eczema in Italy found that the proportion of patients with AD was the highest among those with severe and refractory chronic hand eczema. In addition, certain professions, including those of hairdressers, health professionals, and those in trade work, such as plumbing, were more often associated with chronic hand eczema. “This teaches us that we should be very careful about steering these patients from at-risk occupations,” Dr. Thyssen said. “Also, we should remember to treat them aggressively in the beginning to reduce the risk of severe and refractory chronic hand eczema.”
Dr. Thyssen disclosed that he is a speaker, advisory board member, and/or investigator for Asian, Arena, Almirall, AbbVie, Eli Lilly, LEO Pharma, Pfizer, Regeneron, and Sanofi Genzyme.
An estimated (AD), according to Jacob P. Thyssen, MD, PhD.
“If we look at individuals with AD, the lifetime prevalence of hand eczema reaches 50%, so we see a strong association between hand eczema and AD,” Dr. Thyssen, professor of dermatology at the University of Copenhagen, said at the Revolutionizing Atopic Dermatitis symposium.
Risk factors for hand eczema – defined as eczema on the hand and/or wrists – include AD, which increases the risk by two- to threefold, as well as genetic predisposition beyond AD, exposure to irritants and allergens, female gender, young age, low socioeconomic group, high risk occupations (including construction workers and hairdressers), and tobacco smoking.
“As clinicians, we sometimes need to rule out a few differentials, including psoriasis and T-cell lymphoma. As an example, 10% of T-cell lymphoma patients, a very rare condition, have first onset of the disease on their hands,” Dr. Thyssen said. “Once we see persistent hand eczema, we need to obtain a history of irritant exposure and allergen exposure, both at home and at work, perform a patch test, sometimes a skin prick test, and ask about personal and family history of AD and psoriasis.”
He noted that while formal classification of hand eczema has been a struggle for decades, he favors the “straightforward” clinical approach from the European Environmental and Contact Dermatitis Research Group. Atopic hand eczema, he said, “is very much characterized by dorsal involvement of the hands and fingers and sparse involvement of the palmar aspects of the hands.”
The cheeks and hands are predilection sites for AD in filaggrin mutation carriers (as they are sites of low filaggrin levels), and sometimes harsh environmental exposures, such as cold and dry air. In a study of 3,335 patients in Denmark, Dr. Thyssen and colleagues found that filaggrin mutations and AD were associated with early-onset and persistent hand eczema. In another study of 3,834 adults with AD or psoriasis, he and colleagues found that among those with AD, the wrists, back of the hands, and interdigital areas were often sites of severe eczema, while palmar involvement was more uncommon.
The same findings apply for the feet in filaggrin mutation carriers with AD; the dorsal aspect of the feet was more commonly affected, compared with plantar aspects of the feet.
Medical literature regarding foot eczema is scarce, but a retrospective cohort study from Germany found that foot eczema and hand eczema often co-occur. Among 723 hand eczema patients, 201 (28%) had concomitant foot eczema. The same morphological features were found on the hands and feet in 71% of patients. Foot eczema was significantly associated with male sex, atopic hand eczema, hyperhidrosis, wearing of safety shoes/boots at work, and tobacco smoking.
In addition, a systematic review and meta-analysis of studies of hand eczema and AD found that there was a 4.29-fold increased risk of hand eczema in individuals with AD, and the risk (lifetime prevalence) of occupational hand eczema was increased by more than twofold. “However, this study could not differentiate between irritant contact dermatitis on the hands and atopic dermatitis,” Dr. Thyssen said. “The studies were not accurate enough to allow for any conclusions.”
A multicenter study of adults with hand eczema in Italy found that the proportion of patients with AD was the highest among those with severe and refractory chronic hand eczema. In addition, certain professions, including those of hairdressers, health professionals, and those in trade work, such as plumbing, were more often associated with chronic hand eczema. “This teaches us that we should be very careful about steering these patients from at-risk occupations,” Dr. Thyssen said. “Also, we should remember to treat them aggressively in the beginning to reduce the risk of severe and refractory chronic hand eczema.”
Dr. Thyssen disclosed that he is a speaker, advisory board member, and/or investigator for Asian, Arena, Almirall, AbbVie, Eli Lilly, LEO Pharma, Pfizer, Regeneron, and Sanofi Genzyme.
FROM REVOLUTIONIZING AD 2021
Plaque on heel
Physical exam revealed a plaque with multiple verrucous projections and clusters of smaller circular papules, all with associated thrombosed vessels. The plaque interrupted normal skin lines, consistent with a large, benign, plantar wart, also termed a mosaic wart when clusters of individual plantar warts form a single plaque.
Mosaic warts are caused by infection with human papillomavirus (HPV). They begin as individual papules or macules with a rough surface and small pinpoint capillaries. Plantar warts can be painful if located over a weight-bearing area of the foot. Plantar warts spread by autoinoculation from microtrauma to the foot. Picking at the wart, having it rub against a shoe insert, or exposing it to contaminated surfaces (such as a shower floor) can lead to the wart’s spread. Usually, the diagnosis of a plantar wart is based on clinical examination, with the main differential including a corn or callus. However, rare instances of squamous cell carcinoma or arsenical keratoses can mimic a plantar wart.
Although plantar warts can resolve spontaneously over months or years, patients often seek treatment. Warts may require multiple treatments and various therapies. Common first-line therapies include over-the-counter (OTC) salicylic acid and cryotherapy. The list of other therapies is lengthy, with no single agent credited with high cure rates in well-controlled trials. These therapies include intralesional candida antigen, topical 5 fluorouracil, and topical imiquimod, among many others.
Salicylic acid is available in several forms including 40% acid pads that may be cut to size and applied daily to affected areas. These pads may need to be reinforced with tape to improve adherence. Salicylic acid is also available as a 17% paint-on formulation that can be applied daily, with or without occlusion. This treatment usually requires 2 to 3 months of daily application.
When treated in the office, cryotherapy with liquid nitrogen (LN2) is a first-line therapy, with a cure rate of approximately 65%—similar to that of OTC salicylic acid.1 Application of LN2 via a spray cannister every 2 to 4 weeks until clear is a common strategy. Freezing the area, letting it thaw, and repeating the freeze again in 1 sitting improves clearance. Pain from LN2 can be significant and not all patients can tolerate it. However, for a motivated patient, this can be more convenient than home treatments or a good option when home treatment has failed.
This patient chose cryotherapy, and his foot cleared completely after several rounds of in-office treatments.
Text courtesy of Jonathan Karnes, MD, medical director, MDFMR Dermatology Services, Augusta, ME. Photos courtesy of Jonathan Karnes, MD (copyright retained).
1. Lipke MM. An armamentarium of wart treatments. Clin Med Res. 2006;4:273-293. doi: 10.3121/cmr.4.4.273
Physical exam revealed a plaque with multiple verrucous projections and clusters of smaller circular papules, all with associated thrombosed vessels. The plaque interrupted normal skin lines, consistent with a large, benign, plantar wart, also termed a mosaic wart when clusters of individual plantar warts form a single plaque.
Mosaic warts are caused by infection with human papillomavirus (HPV). They begin as individual papules or macules with a rough surface and small pinpoint capillaries. Plantar warts can be painful if located over a weight-bearing area of the foot. Plantar warts spread by autoinoculation from microtrauma to the foot. Picking at the wart, having it rub against a shoe insert, or exposing it to contaminated surfaces (such as a shower floor) can lead to the wart’s spread. Usually, the diagnosis of a plantar wart is based on clinical examination, with the main differential including a corn or callus. However, rare instances of squamous cell carcinoma or arsenical keratoses can mimic a plantar wart.
Although plantar warts can resolve spontaneously over months or years, patients often seek treatment. Warts may require multiple treatments and various therapies. Common first-line therapies include over-the-counter (OTC) salicylic acid and cryotherapy. The list of other therapies is lengthy, with no single agent credited with high cure rates in well-controlled trials. These therapies include intralesional candida antigen, topical 5 fluorouracil, and topical imiquimod, among many others.
Salicylic acid is available in several forms including 40% acid pads that may be cut to size and applied daily to affected areas. These pads may need to be reinforced with tape to improve adherence. Salicylic acid is also available as a 17% paint-on formulation that can be applied daily, with or without occlusion. This treatment usually requires 2 to 3 months of daily application.
When treated in the office, cryotherapy with liquid nitrogen (LN2) is a first-line therapy, with a cure rate of approximately 65%—similar to that of OTC salicylic acid.1 Application of LN2 via a spray cannister every 2 to 4 weeks until clear is a common strategy. Freezing the area, letting it thaw, and repeating the freeze again in 1 sitting improves clearance. Pain from LN2 can be significant and not all patients can tolerate it. However, for a motivated patient, this can be more convenient than home treatments or a good option when home treatment has failed.
This patient chose cryotherapy, and his foot cleared completely after several rounds of in-office treatments.
Text courtesy of Jonathan Karnes, MD, medical director, MDFMR Dermatology Services, Augusta, ME. Photos courtesy of Jonathan Karnes, MD (copyright retained).
Physical exam revealed a plaque with multiple verrucous projections and clusters of smaller circular papules, all with associated thrombosed vessels. The plaque interrupted normal skin lines, consistent with a large, benign, plantar wart, also termed a mosaic wart when clusters of individual plantar warts form a single plaque.
Mosaic warts are caused by infection with human papillomavirus (HPV). They begin as individual papules or macules with a rough surface and small pinpoint capillaries. Plantar warts can be painful if located over a weight-bearing area of the foot. Plantar warts spread by autoinoculation from microtrauma to the foot. Picking at the wart, having it rub against a shoe insert, or exposing it to contaminated surfaces (such as a shower floor) can lead to the wart’s spread. Usually, the diagnosis of a plantar wart is based on clinical examination, with the main differential including a corn or callus. However, rare instances of squamous cell carcinoma or arsenical keratoses can mimic a plantar wart.
Although plantar warts can resolve spontaneously over months or years, patients often seek treatment. Warts may require multiple treatments and various therapies. Common first-line therapies include over-the-counter (OTC) salicylic acid and cryotherapy. The list of other therapies is lengthy, with no single agent credited with high cure rates in well-controlled trials. These therapies include intralesional candida antigen, topical 5 fluorouracil, and topical imiquimod, among many others.
Salicylic acid is available in several forms including 40% acid pads that may be cut to size and applied daily to affected areas. These pads may need to be reinforced with tape to improve adherence. Salicylic acid is also available as a 17% paint-on formulation that can be applied daily, with or without occlusion. This treatment usually requires 2 to 3 months of daily application.
When treated in the office, cryotherapy with liquid nitrogen (LN2) is a first-line therapy, with a cure rate of approximately 65%—similar to that of OTC salicylic acid.1 Application of LN2 via a spray cannister every 2 to 4 weeks until clear is a common strategy. Freezing the area, letting it thaw, and repeating the freeze again in 1 sitting improves clearance. Pain from LN2 can be significant and not all patients can tolerate it. However, for a motivated patient, this can be more convenient than home treatments or a good option when home treatment has failed.
This patient chose cryotherapy, and his foot cleared completely after several rounds of in-office treatments.
Text courtesy of Jonathan Karnes, MD, medical director, MDFMR Dermatology Services, Augusta, ME. Photos courtesy of Jonathan Karnes, MD (copyright retained).
1. Lipke MM. An armamentarium of wart treatments. Clin Med Res. 2006;4:273-293. doi: 10.3121/cmr.4.4.273
1. Lipke MM. An armamentarium of wart treatments. Clin Med Res. 2006;4:273-293. doi: 10.3121/cmr.4.4.273
What is the diagnosis?
Hidradenitis suppurativa (HS) is a chronic inflammatory skin condition that is becoming more recognized in children. It has a variable presentation, most commonly presenting as painful, recurrent cysts, abscesses, nodules, and/or pustules in classic locations with associated scarring and sinus tract formation.
The majority of patients present with bilateral lesions found most commonly in the axillae and inguinal folds.1 There are myriad other potential sites of involvement including the inframammary folds, inner thighs, buttocks, and groin.1 Diagnosis is made based on history and physical exam. There is a standard severity classification scheme called the Hurley score, which stratifies disease severity based on the presence of sinus tracts and extent of disease.1 HS is associated with comorbid conditions such as obesity, overweight, acne, and inflammatory bowel and joint disease.2 This painful, persistent condition is well documented to have a negative impact on quality of life in adult patients, and similar impairment has been found in pediatric patients.3,4
HS may be increasing in pediatric and adolescent patients, with recent studies showing onset coinciding most commonly with the onset of puberty.1,2 There is often a period of several years between symptom onset and diagnosis.1 A recent editorial highlighted the disparities that exist in HS, with disease more common in Black children and limited information about disease prevalence in Hispanic children.5
What’s the treatment plan?
HS is a difficult disease to treat, with few patients achieving remission and a significant proportion of patients with treatment-refractory disease.1 There are limited studies of HS treatment in pediatric patients. Topical and systemic antibiotic therapy are mainstays of HS treatment, with tetracyclines and a combination of clindamycin plus rifampin commonly used in adults and children alike. Topical therapies including topical antibiotics and antibacterial solutions are frequently used as adjunctive therapy.6 Adalimumab, a tumor necrosis factor receptor blocker, has been Food and Drug Administration approved for HS for ages 12 and up and is currently the only FDA-approved medication for HS in pediatric patients. Our patient was started on 100 mg doxycycline twice daily, with short-dose topical corticosteroids for symptom management of the most inflamed lesions.
What’s on the differential?
Acne conglobata
Acne conglobata is an uncommon, severe variant of acne vulgaris which arise in patients with a history of acne vulgaris and presents with comedones, cysts, abscesses, and scarring with possible drainage of pus. Lesions can present diffusely on the face, back, and body, including in the axillae, groin, and buttocks, and as such can be confused with HS.7
However, in contrast with HS, patients with acne conglobata will also develop disease in non–apocrine gland–bearing skin. This patient’s lack of preceding acne and restriction of lesions to the axillae, inguinal folds, and buttocks makes acne conglobata less likely.
Epidermal inclusion cyst
Epidermal inclusion cyst (EIC) is a common cutaneous cyst, presenting as a well-circumscribed nodule(s) with a central punctum. If not excised, lesions can sometimes become infected and painful.8 In contrast with HS, EIC presents only uncommonly as multiple lesions arising in different areas, and spontaneous drainage is uncommon. Our patient’s development of multiple draining lesions makes this diagnosis unlikely.
Furunculosis
Furunculosis is a common bacterial infection of the skin, presenting with inflammatory nodules or pustules centered around the hair follicle. Lesions may commonly present at sites of skin trauma and are found most frequently on the extremities.9 Though furunculosis lesions may drain pus and can coalesce to form larger “carbuncles,” our patient’s presence of significant scarring and lack of extremity involvement makes HS more likely.
Recurrent MRSA abscesses
Methicillin-resistant Staphylococcus aureus skin and soft-tissue infections are not uncommon in the pediatric population, with presentation of infection ranging from cellulitis to fluid-containing abscesses.10 Recurrent abscesses may be seen in MRSA infection, however in this patient the presence of draining, scarring lesions in multiple locations typical for HS over time is more consistent with a diagnosis of HS.
Dr. Eichenfield is vice chair of the department of dermatology and professor of dermatology and pediatrics at the University of California, San Diego, and Rady Children’s Hospital, San Diego. Ms. Appiah is a pediatric dermatology research associate in the division of pediatric and adolescent dermatology at the University of California, San Diego, and Rady Children’s Hospital. Dr. Eichenfield and Ms. Appiah have no relevant financial disclosures.
References
1. Liy-Wong C et al. JAMA Dermatol. 2021;157(4):385-91.
2. Choi E et al. J Am Acad Dermatol. 2022;86(1):140-7.
3. Machado MO et al. JAMA Dermatol. 2019;155(8):939-45.
4. McAndrew R et al. J Am Acad Dermatol. 2021;84(3):829-30.
5. Kirby JS and Zaenglein AL. JAMA Dermatol. 2021;157(4):379-80.
6. Alikhan A et al. J Am Acad Dermatol. 2019;81(1):91-101.
7. Greydanus DE et al. Dis Mon. 2021;67(4):101103.
8. Weir CB, St. Hilaire NJ. Epidermal Inclusion Cyst, in “StatPearls.” Treasure Island, Fla: StatPearls Publishing, 2021.
9. Atanaskova N and Tomecki KJ. Dermatol Clin. 2010;28(3):479-87.
10. Papastefan ST et al. J Surg Res. 2019;242:70-7.
Hidradenitis suppurativa (HS) is a chronic inflammatory skin condition that is becoming more recognized in children. It has a variable presentation, most commonly presenting as painful, recurrent cysts, abscesses, nodules, and/or pustules in classic locations with associated scarring and sinus tract formation.
The majority of patients present with bilateral lesions found most commonly in the axillae and inguinal folds.1 There are myriad other potential sites of involvement including the inframammary folds, inner thighs, buttocks, and groin.1 Diagnosis is made based on history and physical exam. There is a standard severity classification scheme called the Hurley score, which stratifies disease severity based on the presence of sinus tracts and extent of disease.1 HS is associated with comorbid conditions such as obesity, overweight, acne, and inflammatory bowel and joint disease.2 This painful, persistent condition is well documented to have a negative impact on quality of life in adult patients, and similar impairment has been found in pediatric patients.3,4
HS may be increasing in pediatric and adolescent patients, with recent studies showing onset coinciding most commonly with the onset of puberty.1,2 There is often a period of several years between symptom onset and diagnosis.1 A recent editorial highlighted the disparities that exist in HS, with disease more common in Black children and limited information about disease prevalence in Hispanic children.5
What’s the treatment plan?
HS is a difficult disease to treat, with few patients achieving remission and a significant proportion of patients with treatment-refractory disease.1 There are limited studies of HS treatment in pediatric patients. Topical and systemic antibiotic therapy are mainstays of HS treatment, with tetracyclines and a combination of clindamycin plus rifampin commonly used in adults and children alike. Topical therapies including topical antibiotics and antibacterial solutions are frequently used as adjunctive therapy.6 Adalimumab, a tumor necrosis factor receptor blocker, has been Food and Drug Administration approved for HS for ages 12 and up and is currently the only FDA-approved medication for HS in pediatric patients. Our patient was started on 100 mg doxycycline twice daily, with short-dose topical corticosteroids for symptom management of the most inflamed lesions.
What’s on the differential?
Acne conglobata
Acne conglobata is an uncommon, severe variant of acne vulgaris which arise in patients with a history of acne vulgaris and presents with comedones, cysts, abscesses, and scarring with possible drainage of pus. Lesions can present diffusely on the face, back, and body, including in the axillae, groin, and buttocks, and as such can be confused with HS.7
However, in contrast with HS, patients with acne conglobata will also develop disease in non–apocrine gland–bearing skin. This patient’s lack of preceding acne and restriction of lesions to the axillae, inguinal folds, and buttocks makes acne conglobata less likely.
Epidermal inclusion cyst
Epidermal inclusion cyst (EIC) is a common cutaneous cyst, presenting as a well-circumscribed nodule(s) with a central punctum. If not excised, lesions can sometimes become infected and painful.8 In contrast with HS, EIC presents only uncommonly as multiple lesions arising in different areas, and spontaneous drainage is uncommon. Our patient’s development of multiple draining lesions makes this diagnosis unlikely.
Furunculosis
Furunculosis is a common bacterial infection of the skin, presenting with inflammatory nodules or pustules centered around the hair follicle. Lesions may commonly present at sites of skin trauma and are found most frequently on the extremities.9 Though furunculosis lesions may drain pus and can coalesce to form larger “carbuncles,” our patient’s presence of significant scarring and lack of extremity involvement makes HS more likely.
Recurrent MRSA abscesses
Methicillin-resistant Staphylococcus aureus skin and soft-tissue infections are not uncommon in the pediatric population, with presentation of infection ranging from cellulitis to fluid-containing abscesses.10 Recurrent abscesses may be seen in MRSA infection, however in this patient the presence of draining, scarring lesions in multiple locations typical for HS over time is more consistent with a diagnosis of HS.
Dr. Eichenfield is vice chair of the department of dermatology and professor of dermatology and pediatrics at the University of California, San Diego, and Rady Children’s Hospital, San Diego. Ms. Appiah is a pediatric dermatology research associate in the division of pediatric and adolescent dermatology at the University of California, San Diego, and Rady Children’s Hospital. Dr. Eichenfield and Ms. Appiah have no relevant financial disclosures.
References
1. Liy-Wong C et al. JAMA Dermatol. 2021;157(4):385-91.
2. Choi E et al. J Am Acad Dermatol. 2022;86(1):140-7.
3. Machado MO et al. JAMA Dermatol. 2019;155(8):939-45.
4. McAndrew R et al. J Am Acad Dermatol. 2021;84(3):829-30.
5. Kirby JS and Zaenglein AL. JAMA Dermatol. 2021;157(4):379-80.
6. Alikhan A et al. J Am Acad Dermatol. 2019;81(1):91-101.
7. Greydanus DE et al. Dis Mon. 2021;67(4):101103.
8. Weir CB, St. Hilaire NJ. Epidermal Inclusion Cyst, in “StatPearls.” Treasure Island, Fla: StatPearls Publishing, 2021.
9. Atanaskova N and Tomecki KJ. Dermatol Clin. 2010;28(3):479-87.
10. Papastefan ST et al. J Surg Res. 2019;242:70-7.
Hidradenitis suppurativa (HS) is a chronic inflammatory skin condition that is becoming more recognized in children. It has a variable presentation, most commonly presenting as painful, recurrent cysts, abscesses, nodules, and/or pustules in classic locations with associated scarring and sinus tract formation.
The majority of patients present with bilateral lesions found most commonly in the axillae and inguinal folds.1 There are myriad other potential sites of involvement including the inframammary folds, inner thighs, buttocks, and groin.1 Diagnosis is made based on history and physical exam. There is a standard severity classification scheme called the Hurley score, which stratifies disease severity based on the presence of sinus tracts and extent of disease.1 HS is associated with comorbid conditions such as obesity, overweight, acne, and inflammatory bowel and joint disease.2 This painful, persistent condition is well documented to have a negative impact on quality of life in adult patients, and similar impairment has been found in pediatric patients.3,4
HS may be increasing in pediatric and adolescent patients, with recent studies showing onset coinciding most commonly with the onset of puberty.1,2 There is often a period of several years between symptom onset and diagnosis.1 A recent editorial highlighted the disparities that exist in HS, with disease more common in Black children and limited information about disease prevalence in Hispanic children.5
What’s the treatment plan?
HS is a difficult disease to treat, with few patients achieving remission and a significant proportion of patients with treatment-refractory disease.1 There are limited studies of HS treatment in pediatric patients. Topical and systemic antibiotic therapy are mainstays of HS treatment, with tetracyclines and a combination of clindamycin plus rifampin commonly used in adults and children alike. Topical therapies including topical antibiotics and antibacterial solutions are frequently used as adjunctive therapy.6 Adalimumab, a tumor necrosis factor receptor blocker, has been Food and Drug Administration approved for HS for ages 12 and up and is currently the only FDA-approved medication for HS in pediatric patients. Our patient was started on 100 mg doxycycline twice daily, with short-dose topical corticosteroids for symptom management of the most inflamed lesions.
What’s on the differential?
Acne conglobata
Acne conglobata is an uncommon, severe variant of acne vulgaris which arise in patients with a history of acne vulgaris and presents with comedones, cysts, abscesses, and scarring with possible drainage of pus. Lesions can present diffusely on the face, back, and body, including in the axillae, groin, and buttocks, and as such can be confused with HS.7
However, in contrast with HS, patients with acne conglobata will also develop disease in non–apocrine gland–bearing skin. This patient’s lack of preceding acne and restriction of lesions to the axillae, inguinal folds, and buttocks makes acne conglobata less likely.
Epidermal inclusion cyst
Epidermal inclusion cyst (EIC) is a common cutaneous cyst, presenting as a well-circumscribed nodule(s) with a central punctum. If not excised, lesions can sometimes become infected and painful.8 In contrast with HS, EIC presents only uncommonly as multiple lesions arising in different areas, and spontaneous drainage is uncommon. Our patient’s development of multiple draining lesions makes this diagnosis unlikely.
Furunculosis
Furunculosis is a common bacterial infection of the skin, presenting with inflammatory nodules or pustules centered around the hair follicle. Lesions may commonly present at sites of skin trauma and are found most frequently on the extremities.9 Though furunculosis lesions may drain pus and can coalesce to form larger “carbuncles,” our patient’s presence of significant scarring and lack of extremity involvement makes HS more likely.
Recurrent MRSA abscesses
Methicillin-resistant Staphylococcus aureus skin and soft-tissue infections are not uncommon in the pediatric population, with presentation of infection ranging from cellulitis to fluid-containing abscesses.10 Recurrent abscesses may be seen in MRSA infection, however in this patient the presence of draining, scarring lesions in multiple locations typical for HS over time is more consistent with a diagnosis of HS.
Dr. Eichenfield is vice chair of the department of dermatology and professor of dermatology and pediatrics at the University of California, San Diego, and Rady Children’s Hospital, San Diego. Ms. Appiah is a pediatric dermatology research associate in the division of pediatric and adolescent dermatology at the University of California, San Diego, and Rady Children’s Hospital. Dr. Eichenfield and Ms. Appiah have no relevant financial disclosures.
References
1. Liy-Wong C et al. JAMA Dermatol. 2021;157(4):385-91.
2. Choi E et al. J Am Acad Dermatol. 2022;86(1):140-7.
3. Machado MO et al. JAMA Dermatol. 2019;155(8):939-45.
4. McAndrew R et al. J Am Acad Dermatol. 2021;84(3):829-30.
5. Kirby JS and Zaenglein AL. JAMA Dermatol. 2021;157(4):379-80.
6. Alikhan A et al. J Am Acad Dermatol. 2019;81(1):91-101.
7. Greydanus DE et al. Dis Mon. 2021;67(4):101103.
8. Weir CB, St. Hilaire NJ. Epidermal Inclusion Cyst, in “StatPearls.” Treasure Island, Fla: StatPearls Publishing, 2021.
9. Atanaskova N and Tomecki KJ. Dermatol Clin. 2010;28(3):479-87.
10. Papastefan ST et al. J Surg Res. 2019;242:70-7.
Sorting out sleep complaints in children with AD can be complex
according to Stephen H. Sheldon, DO.
“They wake up frequently,” Dr. Sheldon, professor of pediatrics and neurology at Northwestern University, Chicago, said during the Revolutionizing Atopic Dermatitis symposium. “They may not stay up for long periods of time, but they move about often. There’s a loss of about 50 minutes of sleep per night in children with AD. This loss can result in significant sleep debt the following day. They have difficulty settling at night. Once they get into bed, they have difficulty falling asleep, and many of them have difficulty staying asleep.”
At the sleep medicine center at Lurie Children’s Hospital of Chicago, he and his colleagues have observed that some children with AD complain of difficulty with limb movements. “Part of the issue has been that they have been diagnosed with different sleep-related disorders, such as period limb movement disorder, restless leg syndrome, and growing pain,” Dr. Sheldon said. “Often, they do not know how to describe the manifestations of their leg discomfort in restless leg syndrome and period limb movement disorder and limb movements of sleep.”
Children who complain of growing pains say that their legs hurt, he continued. Sometimes they’ll say that they feel like spiders are crawling on their legs, or that their legs itch, but they often say they have pain in their legs that wakes them up and keeps them from keeping their legs still.
According to the American Academy of Sleep Medicine, periodic limb movement disorder of sleep is characterized by frequent limb movements that last at least 0.5 seconds and are separated by no more than 90 seconds. “They’re four movements in a row that are at least 5 seconds apart,” Dr. Sheldon said.
Interestingly, he added, children who have limb movement disorder have symptoms during the day, similar to adults. “But we see many children with periodic limb movements of sleep whose arms and legs are moving all night, and they don’t have many symptoms during the day.” These children may have difficulty falling or staying asleep, but do not fulfill all of the American Academy of Sleep Medicine criteria for diagnosis of periodic limb movement disorder, he added.
In 2018, Lourdes M. DelRosso, MD, EdD, of Seattle Children’s Hospital, and colleagues described a new sleep problem they termed restless sleep disorder: those who do not fit the criteria for any other sleep disorder but have daytime impairment.
“On video they have very frequent movements – more than five movements an hour of major body activity,” Dr. Sheldon explained. “They’ll move their trunk, their legs, and reposition themselves. We have found that there are many children who presented to the sleep disorder center with restless sleep, limb movement disorder, periodic limb movements of sleep, and daytime symptoms that would fulfill the criteria of periodic limb movement disorder but also have atopic dermatitis.”
Recently, Dr. Sheldon and his colleagues used polysomnographic variables to study children who presented to Lurie Children’s Hospital with AD and symptoms such as difficulty maintaining sleep and snoring with allergic rhinitis. They found that there were increased periods of being awake after the onset of sleep, “meaning the children fell asleep fairly easily in the beginning of the night but they had significant wake after they fell asleep,” he said. “They would wake up in the middle of the night and stay awake for long periods of time – either one long session or multiple shorter sessions throughout the night. They had increased total limb movements per hour of sleep. This means that their limb movements were greater than five events per hour of sleep and it resulted in restless sleep and limb movements that would fulfill the criteria of periodic limb movement disorder.”
Most of these children had mild to moderate AD, he continued. “We feel that the sensory afferent loop in these youngsters doesn’t really turn off completely when they’re asleep. This is ripe for further study, but it makes intuitive sense that if the sensory afferent loop continues during sleep, it may affect the arousal system significantly.”
Dr. Sheldon recommended that any child who presents with a diagnosis of periodic limb movement disorder, periodic limb movements of sleep, or restless sleep disorder should be evaluated for AD. “The treatment then, would first require differentiation between periodic limb movement disorder of sleep and AD. Both should be addressed at the same time in order to solve the child’s daytime AD problem as well as the sleep-related issues that occur with an AD diagnosis.”
He reported having no financial disclosures.
according to Stephen H. Sheldon, DO.
“They wake up frequently,” Dr. Sheldon, professor of pediatrics and neurology at Northwestern University, Chicago, said during the Revolutionizing Atopic Dermatitis symposium. “They may not stay up for long periods of time, but they move about often. There’s a loss of about 50 minutes of sleep per night in children with AD. This loss can result in significant sleep debt the following day. They have difficulty settling at night. Once they get into bed, they have difficulty falling asleep, and many of them have difficulty staying asleep.”
At the sleep medicine center at Lurie Children’s Hospital of Chicago, he and his colleagues have observed that some children with AD complain of difficulty with limb movements. “Part of the issue has been that they have been diagnosed with different sleep-related disorders, such as period limb movement disorder, restless leg syndrome, and growing pain,” Dr. Sheldon said. “Often, they do not know how to describe the manifestations of their leg discomfort in restless leg syndrome and period limb movement disorder and limb movements of sleep.”
Children who complain of growing pains say that their legs hurt, he continued. Sometimes they’ll say that they feel like spiders are crawling on their legs, or that their legs itch, but they often say they have pain in their legs that wakes them up and keeps them from keeping their legs still.
According to the American Academy of Sleep Medicine, periodic limb movement disorder of sleep is characterized by frequent limb movements that last at least 0.5 seconds and are separated by no more than 90 seconds. “They’re four movements in a row that are at least 5 seconds apart,” Dr. Sheldon said.
Interestingly, he added, children who have limb movement disorder have symptoms during the day, similar to adults. “But we see many children with periodic limb movements of sleep whose arms and legs are moving all night, and they don’t have many symptoms during the day.” These children may have difficulty falling or staying asleep, but do not fulfill all of the American Academy of Sleep Medicine criteria for diagnosis of periodic limb movement disorder, he added.
In 2018, Lourdes M. DelRosso, MD, EdD, of Seattle Children’s Hospital, and colleagues described a new sleep problem they termed restless sleep disorder: those who do not fit the criteria for any other sleep disorder but have daytime impairment.
“On video they have very frequent movements – more than five movements an hour of major body activity,” Dr. Sheldon explained. “They’ll move their trunk, their legs, and reposition themselves. We have found that there are many children who presented to the sleep disorder center with restless sleep, limb movement disorder, periodic limb movements of sleep, and daytime symptoms that would fulfill the criteria of periodic limb movement disorder but also have atopic dermatitis.”
Recently, Dr. Sheldon and his colleagues used polysomnographic variables to study children who presented to Lurie Children’s Hospital with AD and symptoms such as difficulty maintaining sleep and snoring with allergic rhinitis. They found that there were increased periods of being awake after the onset of sleep, “meaning the children fell asleep fairly easily in the beginning of the night but they had significant wake after they fell asleep,” he said. “They would wake up in the middle of the night and stay awake for long periods of time – either one long session or multiple shorter sessions throughout the night. They had increased total limb movements per hour of sleep. This means that their limb movements were greater than five events per hour of sleep and it resulted in restless sleep and limb movements that would fulfill the criteria of periodic limb movement disorder.”
Most of these children had mild to moderate AD, he continued. “We feel that the sensory afferent loop in these youngsters doesn’t really turn off completely when they’re asleep. This is ripe for further study, but it makes intuitive sense that if the sensory afferent loop continues during sleep, it may affect the arousal system significantly.”
Dr. Sheldon recommended that any child who presents with a diagnosis of periodic limb movement disorder, periodic limb movements of sleep, or restless sleep disorder should be evaluated for AD. “The treatment then, would first require differentiation between periodic limb movement disorder of sleep and AD. Both should be addressed at the same time in order to solve the child’s daytime AD problem as well as the sleep-related issues that occur with an AD diagnosis.”
He reported having no financial disclosures.
according to Stephen H. Sheldon, DO.
“They wake up frequently,” Dr. Sheldon, professor of pediatrics and neurology at Northwestern University, Chicago, said during the Revolutionizing Atopic Dermatitis symposium. “They may not stay up for long periods of time, but they move about often. There’s a loss of about 50 minutes of sleep per night in children with AD. This loss can result in significant sleep debt the following day. They have difficulty settling at night. Once they get into bed, they have difficulty falling asleep, and many of them have difficulty staying asleep.”
At the sleep medicine center at Lurie Children’s Hospital of Chicago, he and his colleagues have observed that some children with AD complain of difficulty with limb movements. “Part of the issue has been that they have been diagnosed with different sleep-related disorders, such as period limb movement disorder, restless leg syndrome, and growing pain,” Dr. Sheldon said. “Often, they do not know how to describe the manifestations of their leg discomfort in restless leg syndrome and period limb movement disorder and limb movements of sleep.”
Children who complain of growing pains say that their legs hurt, he continued. Sometimes they’ll say that they feel like spiders are crawling on their legs, or that their legs itch, but they often say they have pain in their legs that wakes them up and keeps them from keeping their legs still.
According to the American Academy of Sleep Medicine, periodic limb movement disorder of sleep is characterized by frequent limb movements that last at least 0.5 seconds and are separated by no more than 90 seconds. “They’re four movements in a row that are at least 5 seconds apart,” Dr. Sheldon said.
Interestingly, he added, children who have limb movement disorder have symptoms during the day, similar to adults. “But we see many children with periodic limb movements of sleep whose arms and legs are moving all night, and they don’t have many symptoms during the day.” These children may have difficulty falling or staying asleep, but do not fulfill all of the American Academy of Sleep Medicine criteria for diagnosis of periodic limb movement disorder, he added.
In 2018, Lourdes M. DelRosso, MD, EdD, of Seattle Children’s Hospital, and colleagues described a new sleep problem they termed restless sleep disorder: those who do not fit the criteria for any other sleep disorder but have daytime impairment.
“On video they have very frequent movements – more than five movements an hour of major body activity,” Dr. Sheldon explained. “They’ll move their trunk, their legs, and reposition themselves. We have found that there are many children who presented to the sleep disorder center with restless sleep, limb movement disorder, periodic limb movements of sleep, and daytime symptoms that would fulfill the criteria of periodic limb movement disorder but also have atopic dermatitis.”
Recently, Dr. Sheldon and his colleagues used polysomnographic variables to study children who presented to Lurie Children’s Hospital with AD and symptoms such as difficulty maintaining sleep and snoring with allergic rhinitis. They found that there were increased periods of being awake after the onset of sleep, “meaning the children fell asleep fairly easily in the beginning of the night but they had significant wake after they fell asleep,” he said. “They would wake up in the middle of the night and stay awake for long periods of time – either one long session or multiple shorter sessions throughout the night. They had increased total limb movements per hour of sleep. This means that their limb movements were greater than five events per hour of sleep and it resulted in restless sleep and limb movements that would fulfill the criteria of periodic limb movement disorder.”
Most of these children had mild to moderate AD, he continued. “We feel that the sensory afferent loop in these youngsters doesn’t really turn off completely when they’re asleep. This is ripe for further study, but it makes intuitive sense that if the sensory afferent loop continues during sleep, it may affect the arousal system significantly.”
Dr. Sheldon recommended that any child who presents with a diagnosis of periodic limb movement disorder, periodic limb movements of sleep, or restless sleep disorder should be evaluated for AD. “The treatment then, would first require differentiation between periodic limb movement disorder of sleep and AD. Both should be addressed at the same time in order to solve the child’s daytime AD problem as well as the sleep-related issues that occur with an AD diagnosis.”
He reported having no financial disclosures.
FROM RAD 2021
Proactive infliximab monitoring found best for sustaining control of inflammatory diseases
A new study has found that proactive therapeutic drug monitoring (TDM) with maintenance infliximab is more effective than standard therapy in sustaining control of immune-mediated inflammatory diseases.
The findings from the Norwegian Drug Monitoring B (NOR-DRUM B) trial, published Dec. 21, 2021, in JAMA, provide greater support to the usefulness of TDM in proactively monitoring serum drug levels and antidrug antibodies to infliximab, which has been previously shown to have benefit in patients with inflammatory bowel disease, but leave the benefits of proactive versus reactive monitoring and the cost-effectiveness of the approach in individual immune-mediated inflammatory diseases still open to questioning.
TDM is ‘not the holy grail,’ and that’s OK
“This is an important milestone in the field of TDM with biologics for immunoinflammatory diseases,” Niels Vande Casteele, PharmD, PhD, of the University of California, San Diego, told this news organization. He was not involved in the study.
“When you read through the study, you can see the authors used the TAXIT trial results to inform their study design and the sample size,” he added, referencing his 2015 study on infliximab guide dosing for patients with inflammatory bowel disease, “the first-ever randomized, controlled trial of proactive TDM with any biologic.”
For the TAXIT study’s primary outcome of clinical and biochemical remission at 1 year, “continued concentration-based dosing was not superior to clinically based dosing for achieving remission.” But in regard to their secondary outcome of sustained remission, their results were quite similar to the results of NOR-DRUM B.
“If anything, we already showed a benefit of proactive TDM in 2015,” he said, “but I’m very glad that the authors looked at the trial design and teased out where TDM could be the most important and have the biggest impact, which is to maintain that sustained disease remission over a prolonged period.”
As for next steps, Dr. Vande Casteele noted that TDM isn’t a one-size-fits-all upgrade for drug treatments. But that doesn’t mean it won’t be very useful in many patients.
“What the paper is saying, and what we’ve been finding all along, is that TDM is not the holy grail,” he said. “But it is a tool in the physicians’ toolbox to optimize treatments and maximize efficacy, and there are some patients who truly benefit from it.”
Study details
To determine if proactive TDM with infliximab led to more sustained disease control than standard therapy, first author Silje Watterdal Syversen, MD, PhD, of Diakonhjemmet Hospital in Oslo, and coauthors conducted a 52-week, randomized, parallel-group, open-label trial. From 20 Norwegian hospitals, they recruited 458 patients with rheumatoid arthritis (n = 80), spondyloarthritis (n = 138), psoriatic arthritis (n = 54), ulcerative colitis (n = 81), Crohn’s disease (n = 68), or psoriasis (n = 37) who were undergoing maintenance therapy with the biologic.
The 454 patients who received at least one randomly allocated dose of infliximab were treated with one of two strategies: TDM (n = 227) or standard therapy (n = 227). The TDM group received dose and interval adjustments based on an algorithm that factored in serum drug levels and antidrug antibodies. The standard therapy group was treated on the basis of clinical judgment and physician discretion. The average age across groups was roughly 45 years, and just under 50% were women.
Overall, sustained disease control without worsening was achieved in 167 patients (73.6%) in the TDM group and 127 patients (55.9%) in the standard therapy group, with an estimated adjusted difference of 17.6% (95% confidence interval, 9.0%-26.2%; P < .001). The estimated hazard ratio of disease worsening was 2.1 (95% CI, 1.5-2.9) for standard therapy, compared with TDM. A total of 27 patients (15%) in the standard therapy group and 21 patients (9.2%) in the TDM group developed significant levels of antidrug antibodies, defined here as 50 mcg/L or more.
A total of 34 patients discontinued infliximab in each group; in the TDM group, most discontinued because of antidrug antibody formation, while the main reason for discontinuing in the standard therapy group was disease worsening. Adverse events were reported in 137 patients (60%) in the TDM group and 142 patients (63%) in the standard therapy group.
Removing barriers to TDM
It’s not clear that proactive TDM will benefit treatment with all biologic disease-modifying antirheumatic drugs (bDMARDs), but the findings from Dr. Syversen and colleagues state the clear value of using drug monitoring to guide maintenance therapy with infliximab, Zachary S. Wallace, MD, and Jeffrey A. Sparks, MD, wrote in an accompanying editorial.
“The relatively large sample size and rigorous study design ... helped to overcome some limitations of previous observational studies and small clinical trials that yielded conflicting results regarding TDM,” they added, noting that these findings contrasted somewhat with the NOR-DRUM A trial in which TDM did not improve remission induction in patients initiating infliximab therapy.
Along those lines, they recognized that TDM appears to have a greater effect in patients on maintenance infliximab, compared with those just starting the drug, surmising – among several explanations – that achieving remission in someone beginning treatment is a more difficult outcome to achieve than controlling disease in a patient already in remission.
For now, more clinical trials assessing specific diseases and involving other bDMARDs are needed; Dr. Wallace and Dr. Sparks stated that it’s time to remove barriers to implementing TDM – including the need for medical insurance preauthorization before increasing drug doses – and potentially “introduce a new era in treatment approach to maintenance therapy for patients with immune-mediated inflammatory diseases.”
The authors acknowledged their study’s limitations, including disease worsening being measured in part by patient-physician consensus and thus potentially subject to bias. In addition, they did not have the statistical ability to test TDM effectiveness in each of the six disease groups, noting that “these diseases have inherent differences, and findings may not be completely generalizable across groups.”
The study was funded by grants from the Norwegian Regional Health Authorities and the South-Eastern Norway Regional Health Authorities. The authors reported numerous potential conflicts of interest, including receiving personal fees and grants from various pharmaceutical companies. Dr. Wallace and Dr. Sparks also reported receiving research support and fees from pharmaceutical companies. Dr. Vande Casteele reported receiving research grants and personal fees from multiple pharmaceutical companies, all outside of the reviewed work.
A version of this article first appeared on Medscape.com.
A new study has found that proactive therapeutic drug monitoring (TDM) with maintenance infliximab is more effective than standard therapy in sustaining control of immune-mediated inflammatory diseases.
The findings from the Norwegian Drug Monitoring B (NOR-DRUM B) trial, published Dec. 21, 2021, in JAMA, provide greater support to the usefulness of TDM in proactively monitoring serum drug levels and antidrug antibodies to infliximab, which has been previously shown to have benefit in patients with inflammatory bowel disease, but leave the benefits of proactive versus reactive monitoring and the cost-effectiveness of the approach in individual immune-mediated inflammatory diseases still open to questioning.
TDM is ‘not the holy grail,’ and that’s OK
“This is an important milestone in the field of TDM with biologics for immunoinflammatory diseases,” Niels Vande Casteele, PharmD, PhD, of the University of California, San Diego, told this news organization. He was not involved in the study.
“When you read through the study, you can see the authors used the TAXIT trial results to inform their study design and the sample size,” he added, referencing his 2015 study on infliximab guide dosing for patients with inflammatory bowel disease, “the first-ever randomized, controlled trial of proactive TDM with any biologic.”
For the TAXIT study’s primary outcome of clinical and biochemical remission at 1 year, “continued concentration-based dosing was not superior to clinically based dosing for achieving remission.” But in regard to their secondary outcome of sustained remission, their results were quite similar to the results of NOR-DRUM B.
“If anything, we already showed a benefit of proactive TDM in 2015,” he said, “but I’m very glad that the authors looked at the trial design and teased out where TDM could be the most important and have the biggest impact, which is to maintain that sustained disease remission over a prolonged period.”
As for next steps, Dr. Vande Casteele noted that TDM isn’t a one-size-fits-all upgrade for drug treatments. But that doesn’t mean it won’t be very useful in many patients.
“What the paper is saying, and what we’ve been finding all along, is that TDM is not the holy grail,” he said. “But it is a tool in the physicians’ toolbox to optimize treatments and maximize efficacy, and there are some patients who truly benefit from it.”
Study details
To determine if proactive TDM with infliximab led to more sustained disease control than standard therapy, first author Silje Watterdal Syversen, MD, PhD, of Diakonhjemmet Hospital in Oslo, and coauthors conducted a 52-week, randomized, parallel-group, open-label trial. From 20 Norwegian hospitals, they recruited 458 patients with rheumatoid arthritis (n = 80), spondyloarthritis (n = 138), psoriatic arthritis (n = 54), ulcerative colitis (n = 81), Crohn’s disease (n = 68), or psoriasis (n = 37) who were undergoing maintenance therapy with the biologic.
The 454 patients who received at least one randomly allocated dose of infliximab were treated with one of two strategies: TDM (n = 227) or standard therapy (n = 227). The TDM group received dose and interval adjustments based on an algorithm that factored in serum drug levels and antidrug antibodies. The standard therapy group was treated on the basis of clinical judgment and physician discretion. The average age across groups was roughly 45 years, and just under 50% were women.
Overall, sustained disease control without worsening was achieved in 167 patients (73.6%) in the TDM group and 127 patients (55.9%) in the standard therapy group, with an estimated adjusted difference of 17.6% (95% confidence interval, 9.0%-26.2%; P < .001). The estimated hazard ratio of disease worsening was 2.1 (95% CI, 1.5-2.9) for standard therapy, compared with TDM. A total of 27 patients (15%) in the standard therapy group and 21 patients (9.2%) in the TDM group developed significant levels of antidrug antibodies, defined here as 50 mcg/L or more.
A total of 34 patients discontinued infliximab in each group; in the TDM group, most discontinued because of antidrug antibody formation, while the main reason for discontinuing in the standard therapy group was disease worsening. Adverse events were reported in 137 patients (60%) in the TDM group and 142 patients (63%) in the standard therapy group.
Removing barriers to TDM
It’s not clear that proactive TDM will benefit treatment with all biologic disease-modifying antirheumatic drugs (bDMARDs), but the findings from Dr. Syversen and colleagues state the clear value of using drug monitoring to guide maintenance therapy with infliximab, Zachary S. Wallace, MD, and Jeffrey A. Sparks, MD, wrote in an accompanying editorial.
“The relatively large sample size and rigorous study design ... helped to overcome some limitations of previous observational studies and small clinical trials that yielded conflicting results regarding TDM,” they added, noting that these findings contrasted somewhat with the NOR-DRUM A trial in which TDM did not improve remission induction in patients initiating infliximab therapy.
Along those lines, they recognized that TDM appears to have a greater effect in patients on maintenance infliximab, compared with those just starting the drug, surmising – among several explanations – that achieving remission in someone beginning treatment is a more difficult outcome to achieve than controlling disease in a patient already in remission.
For now, more clinical trials assessing specific diseases and involving other bDMARDs are needed; Dr. Wallace and Dr. Sparks stated that it’s time to remove barriers to implementing TDM – including the need for medical insurance preauthorization before increasing drug doses – and potentially “introduce a new era in treatment approach to maintenance therapy for patients with immune-mediated inflammatory diseases.”
The authors acknowledged their study’s limitations, including disease worsening being measured in part by patient-physician consensus and thus potentially subject to bias. In addition, they did not have the statistical ability to test TDM effectiveness in each of the six disease groups, noting that “these diseases have inherent differences, and findings may not be completely generalizable across groups.”
The study was funded by grants from the Norwegian Regional Health Authorities and the South-Eastern Norway Regional Health Authorities. The authors reported numerous potential conflicts of interest, including receiving personal fees and grants from various pharmaceutical companies. Dr. Wallace and Dr. Sparks also reported receiving research support and fees from pharmaceutical companies. Dr. Vande Casteele reported receiving research grants and personal fees from multiple pharmaceutical companies, all outside of the reviewed work.
A version of this article first appeared on Medscape.com.
A new study has found that proactive therapeutic drug monitoring (TDM) with maintenance infliximab is more effective than standard therapy in sustaining control of immune-mediated inflammatory diseases.
The findings from the Norwegian Drug Monitoring B (NOR-DRUM B) trial, published Dec. 21, 2021, in JAMA, provide greater support to the usefulness of TDM in proactively monitoring serum drug levels and antidrug antibodies to infliximab, which has been previously shown to have benefit in patients with inflammatory bowel disease, but leave the benefits of proactive versus reactive monitoring and the cost-effectiveness of the approach in individual immune-mediated inflammatory diseases still open to questioning.
TDM is ‘not the holy grail,’ and that’s OK
“This is an important milestone in the field of TDM with biologics for immunoinflammatory diseases,” Niels Vande Casteele, PharmD, PhD, of the University of California, San Diego, told this news organization. He was not involved in the study.
“When you read through the study, you can see the authors used the TAXIT trial results to inform their study design and the sample size,” he added, referencing his 2015 study on infliximab guide dosing for patients with inflammatory bowel disease, “the first-ever randomized, controlled trial of proactive TDM with any biologic.”
For the TAXIT study’s primary outcome of clinical and biochemical remission at 1 year, “continued concentration-based dosing was not superior to clinically based dosing for achieving remission.” But in regard to their secondary outcome of sustained remission, their results were quite similar to the results of NOR-DRUM B.
“If anything, we already showed a benefit of proactive TDM in 2015,” he said, “but I’m very glad that the authors looked at the trial design and teased out where TDM could be the most important and have the biggest impact, which is to maintain that sustained disease remission over a prolonged period.”
As for next steps, Dr. Vande Casteele noted that TDM isn’t a one-size-fits-all upgrade for drug treatments. But that doesn’t mean it won’t be very useful in many patients.
“What the paper is saying, and what we’ve been finding all along, is that TDM is not the holy grail,” he said. “But it is a tool in the physicians’ toolbox to optimize treatments and maximize efficacy, and there are some patients who truly benefit from it.”
Study details
To determine if proactive TDM with infliximab led to more sustained disease control than standard therapy, first author Silje Watterdal Syversen, MD, PhD, of Diakonhjemmet Hospital in Oslo, and coauthors conducted a 52-week, randomized, parallel-group, open-label trial. From 20 Norwegian hospitals, they recruited 458 patients with rheumatoid arthritis (n = 80), spondyloarthritis (n = 138), psoriatic arthritis (n = 54), ulcerative colitis (n = 81), Crohn’s disease (n = 68), or psoriasis (n = 37) who were undergoing maintenance therapy with the biologic.
The 454 patients who received at least one randomly allocated dose of infliximab were treated with one of two strategies: TDM (n = 227) or standard therapy (n = 227). The TDM group received dose and interval adjustments based on an algorithm that factored in serum drug levels and antidrug antibodies. The standard therapy group was treated on the basis of clinical judgment and physician discretion. The average age across groups was roughly 45 years, and just under 50% were women.
Overall, sustained disease control without worsening was achieved in 167 patients (73.6%) in the TDM group and 127 patients (55.9%) in the standard therapy group, with an estimated adjusted difference of 17.6% (95% confidence interval, 9.0%-26.2%; P < .001). The estimated hazard ratio of disease worsening was 2.1 (95% CI, 1.5-2.9) for standard therapy, compared with TDM. A total of 27 patients (15%) in the standard therapy group and 21 patients (9.2%) in the TDM group developed significant levels of antidrug antibodies, defined here as 50 mcg/L or more.
A total of 34 patients discontinued infliximab in each group; in the TDM group, most discontinued because of antidrug antibody formation, while the main reason for discontinuing in the standard therapy group was disease worsening. Adverse events were reported in 137 patients (60%) in the TDM group and 142 patients (63%) in the standard therapy group.
Removing barriers to TDM
It’s not clear that proactive TDM will benefit treatment with all biologic disease-modifying antirheumatic drugs (bDMARDs), but the findings from Dr. Syversen and colleagues state the clear value of using drug monitoring to guide maintenance therapy with infliximab, Zachary S. Wallace, MD, and Jeffrey A. Sparks, MD, wrote in an accompanying editorial.
“The relatively large sample size and rigorous study design ... helped to overcome some limitations of previous observational studies and small clinical trials that yielded conflicting results regarding TDM,” they added, noting that these findings contrasted somewhat with the NOR-DRUM A trial in which TDM did not improve remission induction in patients initiating infliximab therapy.
Along those lines, they recognized that TDM appears to have a greater effect in patients on maintenance infliximab, compared with those just starting the drug, surmising – among several explanations – that achieving remission in someone beginning treatment is a more difficult outcome to achieve than controlling disease in a patient already in remission.
For now, more clinical trials assessing specific diseases and involving other bDMARDs are needed; Dr. Wallace and Dr. Sparks stated that it’s time to remove barriers to implementing TDM – including the need for medical insurance preauthorization before increasing drug doses – and potentially “introduce a new era in treatment approach to maintenance therapy for patients with immune-mediated inflammatory diseases.”
The authors acknowledged their study’s limitations, including disease worsening being measured in part by patient-physician consensus and thus potentially subject to bias. In addition, they did not have the statistical ability to test TDM effectiveness in each of the six disease groups, noting that “these diseases have inherent differences, and findings may not be completely generalizable across groups.”
The study was funded by grants from the Norwegian Regional Health Authorities and the South-Eastern Norway Regional Health Authorities. The authors reported numerous potential conflicts of interest, including receiving personal fees and grants from various pharmaceutical companies. Dr. Wallace and Dr. Sparks also reported receiving research support and fees from pharmaceutical companies. Dr. Vande Casteele reported receiving research grants and personal fees from multiple pharmaceutical companies, all outside of the reviewed work.
A version of this article first appeared on Medscape.com.
FROM JAMA
Key questions to ask atopic dermatitis patients with sleep complaints
If you don’t think it’s important to assess for sleep disorders in your patients with atopic dermatitis (AD), think again.
According to Sabra M. Abbott, MD, PhD, professor of neurology at Northwestern University, Chicago, as well as increased night kicks and nocturnal leg cramps, and a more than twofold increased risk for insomnia.
During the Revolutionizing Atopic Dermatitis symposium, she offered key questions to ask AD patients who present with sleep complaints:
When do you go to bed? “This does not refer to when you get into bed, but when do you actually go to bed with an intention to go to sleep, outside of watching television or answering emails?” Dr. Abbott said.
How long does it take for you to fall asleep?
Do you wake up in the middle of the night, and for how long? What do you do if you wake up?
When do you wake up in the morning? Is it on your own, or with an alarm clock?
Does this schedule change on nonworkdays?
Do you have daytime impairment? Meaning, do your sleep complaints impact how you function during the daytime?
Do you snore? Meaning, is there concern for sleep apnea?
Do you have uncomfortable sensations in your legs? Are they worse in the evening and improve with movement? These are signs of possible restless legs syndrome.
The Epworth Sleepiness Scale is one self-administered questionnaire to consider using for AD patients with sleep complaints. “This provides patients with several examples of typical scenarios they might encounter during the day and queries whether or not they feel that they could deal with any of those scenarios,” Dr. Abbott said. “A score of greater than 10 indicates that they are sleepy; it’s not just an overall sense of fatigue and decreased energy.”
Other brief self-assessment tools she recommended are the Insomnia Severity Index and the STOP-Bang questionnaire.
Dr. Abbott reported having no financial disclosures.
If you don’t think it’s important to assess for sleep disorders in your patients with atopic dermatitis (AD), think again.
According to Sabra M. Abbott, MD, PhD, professor of neurology at Northwestern University, Chicago, as well as increased night kicks and nocturnal leg cramps, and a more than twofold increased risk for insomnia.
During the Revolutionizing Atopic Dermatitis symposium, she offered key questions to ask AD patients who present with sleep complaints:
When do you go to bed? “This does not refer to when you get into bed, but when do you actually go to bed with an intention to go to sleep, outside of watching television or answering emails?” Dr. Abbott said.
How long does it take for you to fall asleep?
Do you wake up in the middle of the night, and for how long? What do you do if you wake up?
When do you wake up in the morning? Is it on your own, or with an alarm clock?
Does this schedule change on nonworkdays?
Do you have daytime impairment? Meaning, do your sleep complaints impact how you function during the daytime?
Do you snore? Meaning, is there concern for sleep apnea?
Do you have uncomfortable sensations in your legs? Are they worse in the evening and improve with movement? These are signs of possible restless legs syndrome.
The Epworth Sleepiness Scale is one self-administered questionnaire to consider using for AD patients with sleep complaints. “This provides patients with several examples of typical scenarios they might encounter during the day and queries whether or not they feel that they could deal with any of those scenarios,” Dr. Abbott said. “A score of greater than 10 indicates that they are sleepy; it’s not just an overall sense of fatigue and decreased energy.”
Other brief self-assessment tools she recommended are the Insomnia Severity Index and the STOP-Bang questionnaire.
Dr. Abbott reported having no financial disclosures.
If you don’t think it’s important to assess for sleep disorders in your patients with atopic dermatitis (AD), think again.
According to Sabra M. Abbott, MD, PhD, professor of neurology at Northwestern University, Chicago, as well as increased night kicks and nocturnal leg cramps, and a more than twofold increased risk for insomnia.
During the Revolutionizing Atopic Dermatitis symposium, she offered key questions to ask AD patients who present with sleep complaints:
When do you go to bed? “This does not refer to when you get into bed, but when do you actually go to bed with an intention to go to sleep, outside of watching television or answering emails?” Dr. Abbott said.
How long does it take for you to fall asleep?
Do you wake up in the middle of the night, and for how long? What do you do if you wake up?
When do you wake up in the morning? Is it on your own, or with an alarm clock?
Does this schedule change on nonworkdays?
Do you have daytime impairment? Meaning, do your sleep complaints impact how you function during the daytime?
Do you snore? Meaning, is there concern for sleep apnea?
Do you have uncomfortable sensations in your legs? Are they worse in the evening and improve with movement? These are signs of possible restless legs syndrome.
The Epworth Sleepiness Scale is one self-administered questionnaire to consider using for AD patients with sleep complaints. “This provides patients with several examples of typical scenarios they might encounter during the day and queries whether or not they feel that they could deal with any of those scenarios,” Dr. Abbott said. “A score of greater than 10 indicates that they are sleepy; it’s not just an overall sense of fatigue and decreased energy.”
Other brief self-assessment tools she recommended are the Insomnia Severity Index and the STOP-Bang questionnaire.
Dr. Abbott reported having no financial disclosures.
FROM REVOLUTIONIZING AD 2021
Soon-to-be medical student awarded $10K after spotting melanoma
A soon-to-be medical student and former oncology ward volunteer has received a $10,000 scholarship for her education recently after tipping off a Vancouver Canucks staff member about a cancerous mole on the back of his neck during a National Hockey League game in Seattle this past October.
Sitting immediately behind the visiting team’s bench, Nadia Popovici wrote a large-font message on her cell phone and tapped the protective glass to get the attention of Brian Hamilton, assistant equipment manager for the Canucks.
“The mole on the back of your neck is possibly cancerous. Please go see a doctor!” read the message.
Mr. Hamilton acted on the tip and was eventually diagnosed with a malignant stage II melanoma, according to a report in the Seattle Times.
As noted in a Medscape Q&A, “ABCDE” is the acronym that indicates the visible, physical characteristics suggestive of melanoma. ABCDE stands for asymmetry, irregular border, color variations (especially red, white, and blue tones in a brown or black lesion), diameter greater than 6 mm, and elevated surface. The lesions may itch, bleed, ulcerate, or develop satellites.
The Canucks returned to Seattle recently for another game against the Seattle Kraken, and the visiting team posted a note on social media from Mr. Hamilton seeking the identity of the good Samaritan.
“... the message you showed me on your cell phone will forever be etched into my brain and has made a true life-changing difference for me and my family,” wrote Mr. Hamilton.
Within hours, Ms. Popovici’s mother, whose family has season tickets to the Seattle team’s games, responded to the message.
Ms. Popovici and Mr. Hamilton met up again at the Jan. 1 game, where Ms. Popovici was rewarded with a $10,000 medical school scholarship in a surprise announcement, shared on Twitter and liked more than 42,000 times.
“She didn’t take me out of a burning car like the big stories, but she took me out of a slow fire. And the words out of the doctor’s mouth were, if I ignored that for 4-5 years, I wouldn’t be here,” Mr. Hamilton said at a news conference on Jan. 1.
Ms. Popovici says she has been accepted to several medical schools and will start school in the fall, according to a press release from the National Hockey League.
More money for medical school may be on the way for Ms. Popovici after a GoFundMe page was started. With a goal of $25,000, the fund had received just over $2,500 as of Jan. 4.
“The teams made a kind gesture of giving her 10K, but I think we can do better!” Josh Doxey, a sales manager from Lehi, Utah, wrote on the page he created for Ms. Popovici.
Mr. Doxey told this news organization, “I started the GoFundMe thinking it would be a nice gesture especially for someone going into health care after 2 crazy years of COVID ... I have gotten in touch with her and her mother, and have been chatting with both. They both seem incredibly kind, grateful, and humble.”
A version of this article first appeared on Medscape.com.
A soon-to-be medical student and former oncology ward volunteer has received a $10,000 scholarship for her education recently after tipping off a Vancouver Canucks staff member about a cancerous mole on the back of his neck during a National Hockey League game in Seattle this past October.
Sitting immediately behind the visiting team’s bench, Nadia Popovici wrote a large-font message on her cell phone and tapped the protective glass to get the attention of Brian Hamilton, assistant equipment manager for the Canucks.
“The mole on the back of your neck is possibly cancerous. Please go see a doctor!” read the message.
Mr. Hamilton acted on the tip and was eventually diagnosed with a malignant stage II melanoma, according to a report in the Seattle Times.
As noted in a Medscape Q&A, “ABCDE” is the acronym that indicates the visible, physical characteristics suggestive of melanoma. ABCDE stands for asymmetry, irregular border, color variations (especially red, white, and blue tones in a brown or black lesion), diameter greater than 6 mm, and elevated surface. The lesions may itch, bleed, ulcerate, or develop satellites.
The Canucks returned to Seattle recently for another game against the Seattle Kraken, and the visiting team posted a note on social media from Mr. Hamilton seeking the identity of the good Samaritan.
“... the message you showed me on your cell phone will forever be etched into my brain and has made a true life-changing difference for me and my family,” wrote Mr. Hamilton.
Within hours, Ms. Popovici’s mother, whose family has season tickets to the Seattle team’s games, responded to the message.
Ms. Popovici and Mr. Hamilton met up again at the Jan. 1 game, where Ms. Popovici was rewarded with a $10,000 medical school scholarship in a surprise announcement, shared on Twitter and liked more than 42,000 times.
“She didn’t take me out of a burning car like the big stories, but she took me out of a slow fire. And the words out of the doctor’s mouth were, if I ignored that for 4-5 years, I wouldn’t be here,” Mr. Hamilton said at a news conference on Jan. 1.
Ms. Popovici says she has been accepted to several medical schools and will start school in the fall, according to a press release from the National Hockey League.
More money for medical school may be on the way for Ms. Popovici after a GoFundMe page was started. With a goal of $25,000, the fund had received just over $2,500 as of Jan. 4.
“The teams made a kind gesture of giving her 10K, but I think we can do better!” Josh Doxey, a sales manager from Lehi, Utah, wrote on the page he created for Ms. Popovici.
Mr. Doxey told this news organization, “I started the GoFundMe thinking it would be a nice gesture especially for someone going into health care after 2 crazy years of COVID ... I have gotten in touch with her and her mother, and have been chatting with both. They both seem incredibly kind, grateful, and humble.”
A version of this article first appeared on Medscape.com.
A soon-to-be medical student and former oncology ward volunteer has received a $10,000 scholarship for her education recently after tipping off a Vancouver Canucks staff member about a cancerous mole on the back of his neck during a National Hockey League game in Seattle this past October.
Sitting immediately behind the visiting team’s bench, Nadia Popovici wrote a large-font message on her cell phone and tapped the protective glass to get the attention of Brian Hamilton, assistant equipment manager for the Canucks.
“The mole on the back of your neck is possibly cancerous. Please go see a doctor!” read the message.
Mr. Hamilton acted on the tip and was eventually diagnosed with a malignant stage II melanoma, according to a report in the Seattle Times.
As noted in a Medscape Q&A, “ABCDE” is the acronym that indicates the visible, physical characteristics suggestive of melanoma. ABCDE stands for asymmetry, irregular border, color variations (especially red, white, and blue tones in a brown or black lesion), diameter greater than 6 mm, and elevated surface. The lesions may itch, bleed, ulcerate, or develop satellites.
The Canucks returned to Seattle recently for another game against the Seattle Kraken, and the visiting team posted a note on social media from Mr. Hamilton seeking the identity of the good Samaritan.
“... the message you showed me on your cell phone will forever be etched into my brain and has made a true life-changing difference for me and my family,” wrote Mr. Hamilton.
Within hours, Ms. Popovici’s mother, whose family has season tickets to the Seattle team’s games, responded to the message.
Ms. Popovici and Mr. Hamilton met up again at the Jan. 1 game, where Ms. Popovici was rewarded with a $10,000 medical school scholarship in a surprise announcement, shared on Twitter and liked more than 42,000 times.
“She didn’t take me out of a burning car like the big stories, but she took me out of a slow fire. And the words out of the doctor’s mouth were, if I ignored that for 4-5 years, I wouldn’t be here,” Mr. Hamilton said at a news conference on Jan. 1.
Ms. Popovici says she has been accepted to several medical schools and will start school in the fall, according to a press release from the National Hockey League.
More money for medical school may be on the way for Ms. Popovici after a GoFundMe page was started. With a goal of $25,000, the fund had received just over $2,500 as of Jan. 4.
“The teams made a kind gesture of giving her 10K, but I think we can do better!” Josh Doxey, a sales manager from Lehi, Utah, wrote on the page he created for Ms. Popovici.
Mr. Doxey told this news organization, “I started the GoFundMe thinking it would be a nice gesture especially for someone going into health care after 2 crazy years of COVID ... I have gotten in touch with her and her mother, and have been chatting with both. They both seem incredibly kind, grateful, and humble.”
A version of this article first appeared on Medscape.com.