Sharon Worcester is an award-winning medical journalist for MDedge News. She has been with the company since 1996, first as the Southeast Bureau Chief (1996-2009) when the company was known as International Medical News Group, then as a freelance writer (2010-2015) before returning as a reporter in 2015. She previously worked as a daily newspaper reporter covering health and local government. Sharon currently reports primarily on oncology and hematology. She has a BA from Eckerd College and an MA in Mass Communication/Print Journalism from the University of Florida. Connect with her via LinkedIn and follow her on twitter @SW_MedReporter.

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Diagnosis: Myofibroma

Infantile myofibromatosis is a rare and potentially life-threatening condition that should be considered in children who present with multiple skin nodules, Dr. Ivan D. Camacho reported at the annual pre-AAD meeting of the Society for Pediatric Dermatology.

"To our knowledge, this is the first report of a case of myofibromatosis of infancy confined to the genital area," said Dr. Camacho, a dermatology fellow at the University of Miami.

The myofibroma in this case was diagnosed following a punch biopsy, which demonstrated proliferative, plump, spindle-shaped cells forming interweaving fascicles imbedded in a fibromyxoid stroma. Smooth muscle actin and vimentin stains were positive, and desmin, cytokeratin, and S-100 stains were negative, which is consistent with the diagnosis of myofibroma, he said.

Myofibromas are rare, mesenchymal tumors that can present as a single lesion or in groups. They are firm, skin-colored to violaceous nodules that can involve the skin, subcutaneous tissues, striated muscles, bones, and viscera. Multiple lesions in a newborn or infant are known as infantile myofibromatosis. In most cases, myofibromas occur as solitary lesions that rarely involve the viscera.

Multiple lesions, however, often involve soft tissues, bone, and viscera and are associated with adverse prognosis and outcome, with mortality resulting from airway obstruction, intestinal obstruction, failure to thrive, or infection. In rare cases, the brain, orbit, and testis might be involved.

The lesions should be differentiated from those associated with neurofibromatosis, fibrous hamartomas of infancy, sarcomas, granuloma gluteale infantum, and vascular tumors. Patients with multicentric cases should undergo systemic evaluation for involvement of the viscera because surgery, chemotherapy, and radiotherapy might be beneficial in those with visceral involvement. Patients without visceral involvement have an excellent prognosis, with the lesions typically regressing spontaneously over 1–2 years, as was the case in this child, Dr. Camacho said.

At follow-up, the patient's lesions were resolving spontaneously and his mother refused further work-up.

Courtesty Dr. Ivan D. Camacho

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Diagnosis: Myofibroma

Infantile myofibromatosis is a rare and potentially life-threatening condition that should be considered in children who present with multiple skin nodules, Dr. Ivan D. Camacho reported at the annual pre-AAD meeting of the Society for Pediatric Dermatology.

"To our knowledge, this is the first report of a case of myofibromatosis of infancy confined to the genital area," said Dr. Camacho, a dermatology fellow at the University of Miami.

The myofibroma in this case was diagnosed following a punch biopsy, which demonstrated proliferative, plump, spindle-shaped cells forming interweaving fascicles imbedded in a fibromyxoid stroma. Smooth muscle actin and vimentin stains were positive, and desmin, cytokeratin, and S-100 stains were negative, which is consistent with the diagnosis of myofibroma, he said.

Myofibromas are rare, mesenchymal tumors that can present as a single lesion or in groups. They are firm, skin-colored to violaceous nodules that can involve the skin, subcutaneous tissues, striated muscles, bones, and viscera. Multiple lesions in a newborn or infant are known as infantile myofibromatosis. In most cases, myofibromas occur as solitary lesions that rarely involve the viscera.

Multiple lesions, however, often involve soft tissues, bone, and viscera and are associated with adverse prognosis and outcome, with mortality resulting from airway obstruction, intestinal obstruction, failure to thrive, or infection. In rare cases, the brain, orbit, and testis might be involved.

The lesions should be differentiated from those associated with neurofibromatosis, fibrous hamartomas of infancy, sarcomas, granuloma gluteale infantum, and vascular tumors. Patients with multicentric cases should undergo systemic evaluation for involvement of the viscera because surgery, chemotherapy, and radiotherapy might be beneficial in those with visceral involvement. Patients without visceral involvement have an excellent prognosis, with the lesions typically regressing spontaneously over 1–2 years, as was the case in this child, Dr. Camacho said.

At follow-up, the patient's lesions were resolving spontaneously and his mother refused further work-up.

Courtesty Dr. Ivan D. Camacho

Diagnosis: Myofibroma

Infantile myofibromatosis is a rare and potentially life-threatening condition that should be considered in children who present with multiple skin nodules, Dr. Ivan D. Camacho reported at the annual pre-AAD meeting of the Society for Pediatric Dermatology.

"To our knowledge, this is the first report of a case of myofibromatosis of infancy confined to the genital area," said Dr. Camacho, a dermatology fellow at the University of Miami.

The myofibroma in this case was diagnosed following a punch biopsy, which demonstrated proliferative, plump, spindle-shaped cells forming interweaving fascicles imbedded in a fibromyxoid stroma. Smooth muscle actin and vimentin stains were positive, and desmin, cytokeratin, and S-100 stains were negative, which is consistent with the diagnosis of myofibroma, he said.

Myofibromas are rare, mesenchymal tumors that can present as a single lesion or in groups. They are firm, skin-colored to violaceous nodules that can involve the skin, subcutaneous tissues, striated muscles, bones, and viscera. Multiple lesions in a newborn or infant are known as infantile myofibromatosis. In most cases, myofibromas occur as solitary lesions that rarely involve the viscera.

Multiple lesions, however, often involve soft tissues, bone, and viscera and are associated with adverse prognosis and outcome, with mortality resulting from airway obstruction, intestinal obstruction, failure to thrive, or infection. In rare cases, the brain, orbit, and testis might be involved.

The lesions should be differentiated from those associated with neurofibromatosis, fibrous hamartomas of infancy, sarcomas, granuloma gluteale infantum, and vascular tumors. Patients with multicentric cases should undergo systemic evaluation for involvement of the viscera because surgery, chemotherapy, and radiotherapy might be beneficial in those with visceral involvement. Patients without visceral involvement have an excellent prognosis, with the lesions typically regressing spontaneously over 1–2 years, as was the case in this child, Dr. Camacho said.

At follow-up, the patient's lesions were resolving spontaneously and his mother refused further work-up.

Courtesty Dr. Ivan D. Camacho

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Mycosis Fungoides' Therapies Make Tx 'Rewarding'

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SAN ANTONIO — The treatment of most patients who have mycosis fungoides is well within the purview of dermatologists.

"It's very rewarding caring for these patients, because they respond to so many different therapies," Dr. L. Frank Glass said at the annual meeting of the American Academy of Dermatology.

In fact, most patients do very well and don't die from this disease, which is the most common of the cutaneous T-cell lymphomas. Its treatment resembles that of a chronic disease, such as psoriasis, more than that of a terminal illness, said Dr. Glass of the University of South Florida, Tampa.

From topical steroids and retinoids to alkylating agents and phototherapy, the range of treatments for cutaneous T-cell lymphomas is expansive and provides options for successfully treating the many variants of the disease. Furthermore, these are treatments with which dermatologists, compared with other specialists, have the most extensive experience.

"We're used to using retinoids orally," he said, noting that even imiquimod—another drug with which dermatologists have extensive experience—is considered an off-label option for the treatment of mycosis fungoides.

Dermatologists will mainly see patients with disease up to the limited patch-plaque stage. Disease progression in these patients tends to be limited, and some patients with very early-stage disease have been shown to have the same survival as the general population.

At least one study has shown that those patients who receive conservative sequential therapy do as well as those patients who receive aggressive chemotherapy and radiation treatment, Dr. Glass explained.

Even with patients who have more advanced tumor-stage disease that requires multispecialty care, dermatologists can continue to play a role in treatment, thanks to the following modalities now available:

Topical corticosteroids. Class I corticosteroids tend to work best for mycosis fungoides patients, but should be avoided in those with atrophic disease variants. When they are appropriate, corticosteroids tend to work well for itching and redness. Corticosteroids are particularly useful as adjuvants with other therapies.

Phototherapy. PUVA is best, but narrow-band phototherapy offers more convenience and also has good results. The choice depends on the stage and type of lesion, as well as patient risk factors, Dr. Glass said.

Although response rates are similar with PUVA and narrow-band light, there are some questions about the durability of response with narrow-band light and whether thicker lesions respond as well to this form of phototherapy. In those with higher melanoma risk, however, narrow-band light may be safer.

Phototherapy is great as a maintenance therapy, but in those with progressive disease, relapse rates increase and combination therapy with a systemic agent may be necessary.

Extracorporeal photophoresis. This treatment is quite effective, particularly in patients with erythrodermic mycosis fungoides and Sézary syndrome. It is the treatment of choice for the former, and is "the beginning of treatment" for the latter, he said.

Bexarotene. Topical bexarotene is promising, with a similar mechanism of action to other retinoids, but at nearly $2,000 per tube it is too expensive to be considered a viable option at this time, Dr. Glass noted.

Oral bexarotene is more accessible and works well in combination with other therapies, such as PUVA.

Using oral bexarotene in a combination allows the dosage of both agents to be reduced, thus maintaining good response but reducing the risk of adverse effects, such as hypertriglyceridemia and hypothyroidism.

However, Dr. Glass noted that when he uses bexarotene in combination with another treatment for sustained therapy, he brings in an internist to ensure that the patient doesn't have an increased cardiac risk or a metabolic problem "down the road."

Nonetheless, combination therapy is "pretty effective and can certainly be initiated" by dermatologists with fewer side effects, he said.

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SAN ANTONIO — The treatment of most patients who have mycosis fungoides is well within the purview of dermatologists.

"It's very rewarding caring for these patients, because they respond to so many different therapies," Dr. L. Frank Glass said at the annual meeting of the American Academy of Dermatology.

In fact, most patients do very well and don't die from this disease, which is the most common of the cutaneous T-cell lymphomas. Its treatment resembles that of a chronic disease, such as psoriasis, more than that of a terminal illness, said Dr. Glass of the University of South Florida, Tampa.

From topical steroids and retinoids to alkylating agents and phototherapy, the range of treatments for cutaneous T-cell lymphomas is expansive and provides options for successfully treating the many variants of the disease. Furthermore, these are treatments with which dermatologists, compared with other specialists, have the most extensive experience.

"We're used to using retinoids orally," he said, noting that even imiquimod—another drug with which dermatologists have extensive experience—is considered an off-label option for the treatment of mycosis fungoides.

Dermatologists will mainly see patients with disease up to the limited patch-plaque stage. Disease progression in these patients tends to be limited, and some patients with very early-stage disease have been shown to have the same survival as the general population.

At least one study has shown that those patients who receive conservative sequential therapy do as well as those patients who receive aggressive chemotherapy and radiation treatment, Dr. Glass explained.

Even with patients who have more advanced tumor-stage disease that requires multispecialty care, dermatologists can continue to play a role in treatment, thanks to the following modalities now available:

Topical corticosteroids. Class I corticosteroids tend to work best for mycosis fungoides patients, but should be avoided in those with atrophic disease variants. When they are appropriate, corticosteroids tend to work well for itching and redness. Corticosteroids are particularly useful as adjuvants with other therapies.

Phototherapy. PUVA is best, but narrow-band phototherapy offers more convenience and also has good results. The choice depends on the stage and type of lesion, as well as patient risk factors, Dr. Glass said.

Although response rates are similar with PUVA and narrow-band light, there are some questions about the durability of response with narrow-band light and whether thicker lesions respond as well to this form of phototherapy. In those with higher melanoma risk, however, narrow-band light may be safer.

Phototherapy is great as a maintenance therapy, but in those with progressive disease, relapse rates increase and combination therapy with a systemic agent may be necessary.

Extracorporeal photophoresis. This treatment is quite effective, particularly in patients with erythrodermic mycosis fungoides and Sézary syndrome. It is the treatment of choice for the former, and is "the beginning of treatment" for the latter, he said.

Bexarotene. Topical bexarotene is promising, with a similar mechanism of action to other retinoids, but at nearly $2,000 per tube it is too expensive to be considered a viable option at this time, Dr. Glass noted.

Oral bexarotene is more accessible and works well in combination with other therapies, such as PUVA.

Using oral bexarotene in a combination allows the dosage of both agents to be reduced, thus maintaining good response but reducing the risk of adverse effects, such as hypertriglyceridemia and hypothyroidism.

However, Dr. Glass noted that when he uses bexarotene in combination with another treatment for sustained therapy, he brings in an internist to ensure that the patient doesn't have an increased cardiac risk or a metabolic problem "down the road."

Nonetheless, combination therapy is "pretty effective and can certainly be initiated" by dermatologists with fewer side effects, he said.

SAN ANTONIO — The treatment of most patients who have mycosis fungoides is well within the purview of dermatologists.

"It's very rewarding caring for these patients, because they respond to so many different therapies," Dr. L. Frank Glass said at the annual meeting of the American Academy of Dermatology.

In fact, most patients do very well and don't die from this disease, which is the most common of the cutaneous T-cell lymphomas. Its treatment resembles that of a chronic disease, such as psoriasis, more than that of a terminal illness, said Dr. Glass of the University of South Florida, Tampa.

From topical steroids and retinoids to alkylating agents and phototherapy, the range of treatments for cutaneous T-cell lymphomas is expansive and provides options for successfully treating the many variants of the disease. Furthermore, these are treatments with which dermatologists, compared with other specialists, have the most extensive experience.

"We're used to using retinoids orally," he said, noting that even imiquimod—another drug with which dermatologists have extensive experience—is considered an off-label option for the treatment of mycosis fungoides.

Dermatologists will mainly see patients with disease up to the limited patch-plaque stage. Disease progression in these patients tends to be limited, and some patients with very early-stage disease have been shown to have the same survival as the general population.

At least one study has shown that those patients who receive conservative sequential therapy do as well as those patients who receive aggressive chemotherapy and radiation treatment, Dr. Glass explained.

Even with patients who have more advanced tumor-stage disease that requires multispecialty care, dermatologists can continue to play a role in treatment, thanks to the following modalities now available:

Topical corticosteroids. Class I corticosteroids tend to work best for mycosis fungoides patients, but should be avoided in those with atrophic disease variants. When they are appropriate, corticosteroids tend to work well for itching and redness. Corticosteroids are particularly useful as adjuvants with other therapies.

Phototherapy. PUVA is best, but narrow-band phototherapy offers more convenience and also has good results. The choice depends on the stage and type of lesion, as well as patient risk factors, Dr. Glass said.

Although response rates are similar with PUVA and narrow-band light, there are some questions about the durability of response with narrow-band light and whether thicker lesions respond as well to this form of phototherapy. In those with higher melanoma risk, however, narrow-band light may be safer.

Phototherapy is great as a maintenance therapy, but in those with progressive disease, relapse rates increase and combination therapy with a systemic agent may be necessary.

Extracorporeal photophoresis. This treatment is quite effective, particularly in patients with erythrodermic mycosis fungoides and Sézary syndrome. It is the treatment of choice for the former, and is "the beginning of treatment" for the latter, he said.

Bexarotene. Topical bexarotene is promising, with a similar mechanism of action to other retinoids, but at nearly $2,000 per tube it is too expensive to be considered a viable option at this time, Dr. Glass noted.

Oral bexarotene is more accessible and works well in combination with other therapies, such as PUVA.

Using oral bexarotene in a combination allows the dosage of both agents to be reduced, thus maintaining good response but reducing the risk of adverse effects, such as hypertriglyceridemia and hypothyroidism.

However, Dr. Glass noted that when he uses bexarotene in combination with another treatment for sustained therapy, he brings in an internist to ensure that the patient doesn't have an increased cardiac risk or a metabolic problem "down the road."

Nonetheless, combination therapy is "pretty effective and can certainly be initiated" by dermatologists with fewer side effects, he said.

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Total Body Photography Helps Reduce Unnecessary Biopsies

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SAN ANTONIO — The use of total body photography as a surveillance tool for melanoma has great potential to reduce the number of unnecessary biopsies, Dr. Allan C. Halpern said at the annual meeting of the American Academy of Dermatology.

When used appropriately in conjunction with self-examination and regular follow-up, total body photography (TBP) can also increase the likelihood of detecting thinner melanomas, said Dr. Halpern, chief of dermatology at Memorial Sloan-Kettering Cancer Center, New York.

Although it does have some disadvantages—namely the possibility of raising the threshold for removal of lesions in favor of follow-up in patients who may not return for follow-up—it also has a number of possible advantages for both patients and physicians, he said.

The key is to use TBP cautiously. The first visit is not the time to raise the threshold for removing a suspicious lesion in anticipation of using TBP for surveillance. Instead, build a relationship before relying on the patient to perform self-evaluations and come in for routine follow-up visits. Once a relationship is established and the patient is compliant, TBP can be a great tool for engaging patients in their own care and increasing patient satisfaction, he noted.

The sensitivity and specificity of TBP for melanoma are increased in those who do come back. Studies have shown that patients who are engaged in their care because they receive copies of the photos and are asked to do monthly self-examinations by comparing lesions with the photos are more likely to do self-examinations and are more likely to be effective when performing self-examinations than are patients who do not receive photos, Dr. Halpern said.

As a result, the use of TBP is increasing. A survey of AAD members showed 63% of 105 residency programs use TBP and 49% of AAD members use it at least some of the time in patients with dysplastic nevi. Furthermore, 83% of programs with specialized pigmented lesions clinics and 49% of those without such a clinic are using TBP.

Those who don't use TBP cite perceived logistical difficulties, financial constraints, and doubt about its benefits as reasons for not using it, he said.

The use of TBP requires only a digital camera of at least 6–12 megapixels (although he uses one with 40 megapixels), a computer, and a space with good lighting and the availability of a blue or black backdrop, Dr. Halpern explained, also noting that a CPT code for TBP exists.

As for benefits, one small study showed no difference in detection of melanoma for those who used and didn't use TBP. It did show an increase in sensitivity and specificity for detection of nonmelanomas, and another showed that twice as many patients who received photos were compliant with recommended care, including self-examination, than those who were not.

The actual taking of the photographs can be uncomfortable for the patient, so it is a good idea to perform a physical examination first. Dr. Halpern always starts with the patient facing away from him to allow the patient time to acclimate to the discomfort of the situation and to allow himself time to regain composure before facing the patient should he encounter an alarming lesion.

Photos can be taken by the physician, a specially trained nurse, or a medical photographer. Some practices have a photographer on staff, and hospitals may employ photographers and be accommodating when it comes to TBP services. "You can achieve very high-quality pictures if you nail down a system and use it in a sufficiently standardized fashion," Dr. Halpern said, noting that there are papers in the literature to provide guidance for using TBP.

Basically, as much of the body surface as possible should be photographed, and positioning should be chosen to allow this.

Side-by-side (photos and patient) examinations can then be conducted at follow-up visits. He recommended examining patients while they are standing, which makes it easier to compare lesions against those in the photos.

Patient privacy needs to be carefully protected, so photos kept on office computers should be encrypted, he said.

Patients should be provided with hard copies and a compact disk along with a photo-marking pen that they can use to mark the photographs if they find something of concern on their monthly self-examination.

It is important to inform patients that their role in performing self-examinations is not meant to be anxiety provoking; rather it should be an exercise in becoming familiar with the big picture so they can recognize obvious changes and fast-growing lesions that might be of concern.

 

 

Dr. Halpern used a night-sky analogy to describe how patients should view their photos. If they become familiar with their own "constellations," they will notice when something new appears in the field, or if something other than the North Star is shining brightest. The patient's job is to notice the obvious changes; the physician's job is to find the subtle changes, he said.

As for which patients are the best candidates for TBP, he suggested using it for those with dysplastic nevi who have undergone many excisions and those with a familial or personal history of melanoma. No prospective data exist to guide how often patients should be seen, but every 6 months has been a good interval in Dr. Halpern's experience. "We do find the vast majority of melanomas in surveillance with these patients. … This is one of the major reasons for doing total body photograph."

Patients who receive copies of their photos, and are asked to do monthly self-exams, are more likely to do the exams and be effective in doing so, said Dr. Allan C. Halpern. Daphne Demas/MSKCC Dermatology

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SAN ANTONIO — The use of total body photography as a surveillance tool for melanoma has great potential to reduce the number of unnecessary biopsies, Dr. Allan C. Halpern said at the annual meeting of the American Academy of Dermatology.

When used appropriately in conjunction with self-examination and regular follow-up, total body photography (TBP) can also increase the likelihood of detecting thinner melanomas, said Dr. Halpern, chief of dermatology at Memorial Sloan-Kettering Cancer Center, New York.

Although it does have some disadvantages—namely the possibility of raising the threshold for removal of lesions in favor of follow-up in patients who may not return for follow-up—it also has a number of possible advantages for both patients and physicians, he said.

The key is to use TBP cautiously. The first visit is not the time to raise the threshold for removing a suspicious lesion in anticipation of using TBP for surveillance. Instead, build a relationship before relying on the patient to perform self-evaluations and come in for routine follow-up visits. Once a relationship is established and the patient is compliant, TBP can be a great tool for engaging patients in their own care and increasing patient satisfaction, he noted.

The sensitivity and specificity of TBP for melanoma are increased in those who do come back. Studies have shown that patients who are engaged in their care because they receive copies of the photos and are asked to do monthly self-examinations by comparing lesions with the photos are more likely to do self-examinations and are more likely to be effective when performing self-examinations than are patients who do not receive photos, Dr. Halpern said.

As a result, the use of TBP is increasing. A survey of AAD members showed 63% of 105 residency programs use TBP and 49% of AAD members use it at least some of the time in patients with dysplastic nevi. Furthermore, 83% of programs with specialized pigmented lesions clinics and 49% of those without such a clinic are using TBP.

Those who don't use TBP cite perceived logistical difficulties, financial constraints, and doubt about its benefits as reasons for not using it, he said.

The use of TBP requires only a digital camera of at least 6–12 megapixels (although he uses one with 40 megapixels), a computer, and a space with good lighting and the availability of a blue or black backdrop, Dr. Halpern explained, also noting that a CPT code for TBP exists.

As for benefits, one small study showed no difference in detection of melanoma for those who used and didn't use TBP. It did show an increase in sensitivity and specificity for detection of nonmelanomas, and another showed that twice as many patients who received photos were compliant with recommended care, including self-examination, than those who were not.

The actual taking of the photographs can be uncomfortable for the patient, so it is a good idea to perform a physical examination first. Dr. Halpern always starts with the patient facing away from him to allow the patient time to acclimate to the discomfort of the situation and to allow himself time to regain composure before facing the patient should he encounter an alarming lesion.

Photos can be taken by the physician, a specially trained nurse, or a medical photographer. Some practices have a photographer on staff, and hospitals may employ photographers and be accommodating when it comes to TBP services. "You can achieve very high-quality pictures if you nail down a system and use it in a sufficiently standardized fashion," Dr. Halpern said, noting that there are papers in the literature to provide guidance for using TBP.

Basically, as much of the body surface as possible should be photographed, and positioning should be chosen to allow this.

Side-by-side (photos and patient) examinations can then be conducted at follow-up visits. He recommended examining patients while they are standing, which makes it easier to compare lesions against those in the photos.

Patient privacy needs to be carefully protected, so photos kept on office computers should be encrypted, he said.

Patients should be provided with hard copies and a compact disk along with a photo-marking pen that they can use to mark the photographs if they find something of concern on their monthly self-examination.

It is important to inform patients that their role in performing self-examinations is not meant to be anxiety provoking; rather it should be an exercise in becoming familiar with the big picture so they can recognize obvious changes and fast-growing lesions that might be of concern.

 

 

Dr. Halpern used a night-sky analogy to describe how patients should view their photos. If they become familiar with their own "constellations," they will notice when something new appears in the field, or if something other than the North Star is shining brightest. The patient's job is to notice the obvious changes; the physician's job is to find the subtle changes, he said.

As for which patients are the best candidates for TBP, he suggested using it for those with dysplastic nevi who have undergone many excisions and those with a familial or personal history of melanoma. No prospective data exist to guide how often patients should be seen, but every 6 months has been a good interval in Dr. Halpern's experience. "We do find the vast majority of melanomas in surveillance with these patients. … This is one of the major reasons for doing total body photograph."

Patients who receive copies of their photos, and are asked to do monthly self-exams, are more likely to do the exams and be effective in doing so, said Dr. Allan C. Halpern. Daphne Demas/MSKCC Dermatology

SAN ANTONIO — The use of total body photography as a surveillance tool for melanoma has great potential to reduce the number of unnecessary biopsies, Dr. Allan C. Halpern said at the annual meeting of the American Academy of Dermatology.

When used appropriately in conjunction with self-examination and regular follow-up, total body photography (TBP) can also increase the likelihood of detecting thinner melanomas, said Dr. Halpern, chief of dermatology at Memorial Sloan-Kettering Cancer Center, New York.

Although it does have some disadvantages—namely the possibility of raising the threshold for removal of lesions in favor of follow-up in patients who may not return for follow-up—it also has a number of possible advantages for both patients and physicians, he said.

The key is to use TBP cautiously. The first visit is not the time to raise the threshold for removing a suspicious lesion in anticipation of using TBP for surveillance. Instead, build a relationship before relying on the patient to perform self-evaluations and come in for routine follow-up visits. Once a relationship is established and the patient is compliant, TBP can be a great tool for engaging patients in their own care and increasing patient satisfaction, he noted.

The sensitivity and specificity of TBP for melanoma are increased in those who do come back. Studies have shown that patients who are engaged in their care because they receive copies of the photos and are asked to do monthly self-examinations by comparing lesions with the photos are more likely to do self-examinations and are more likely to be effective when performing self-examinations than are patients who do not receive photos, Dr. Halpern said.

As a result, the use of TBP is increasing. A survey of AAD members showed 63% of 105 residency programs use TBP and 49% of AAD members use it at least some of the time in patients with dysplastic nevi. Furthermore, 83% of programs with specialized pigmented lesions clinics and 49% of those without such a clinic are using TBP.

Those who don't use TBP cite perceived logistical difficulties, financial constraints, and doubt about its benefits as reasons for not using it, he said.

The use of TBP requires only a digital camera of at least 6–12 megapixels (although he uses one with 40 megapixels), a computer, and a space with good lighting and the availability of a blue or black backdrop, Dr. Halpern explained, also noting that a CPT code for TBP exists.

As for benefits, one small study showed no difference in detection of melanoma for those who used and didn't use TBP. It did show an increase in sensitivity and specificity for detection of nonmelanomas, and another showed that twice as many patients who received photos were compliant with recommended care, including self-examination, than those who were not.

The actual taking of the photographs can be uncomfortable for the patient, so it is a good idea to perform a physical examination first. Dr. Halpern always starts with the patient facing away from him to allow the patient time to acclimate to the discomfort of the situation and to allow himself time to regain composure before facing the patient should he encounter an alarming lesion.

Photos can be taken by the physician, a specially trained nurse, or a medical photographer. Some practices have a photographer on staff, and hospitals may employ photographers and be accommodating when it comes to TBP services. "You can achieve very high-quality pictures if you nail down a system and use it in a sufficiently standardized fashion," Dr. Halpern said, noting that there are papers in the literature to provide guidance for using TBP.

Basically, as much of the body surface as possible should be photographed, and positioning should be chosen to allow this.

Side-by-side (photos and patient) examinations can then be conducted at follow-up visits. He recommended examining patients while they are standing, which makes it easier to compare lesions against those in the photos.

Patient privacy needs to be carefully protected, so photos kept on office computers should be encrypted, he said.

Patients should be provided with hard copies and a compact disk along with a photo-marking pen that they can use to mark the photographs if they find something of concern on their monthly self-examination.

It is important to inform patients that their role in performing self-examinations is not meant to be anxiety provoking; rather it should be an exercise in becoming familiar with the big picture so they can recognize obvious changes and fast-growing lesions that might be of concern.

 

 

Dr. Halpern used a night-sky analogy to describe how patients should view their photos. If they become familiar with their own "constellations," they will notice when something new appears in the field, or if something other than the North Star is shining brightest. The patient's job is to notice the obvious changes; the physician's job is to find the subtle changes, he said.

As for which patients are the best candidates for TBP, he suggested using it for those with dysplastic nevi who have undergone many excisions and those with a familial or personal history of melanoma. No prospective data exist to guide how often patients should be seen, but every 6 months has been a good interval in Dr. Halpern's experience. "We do find the vast majority of melanomas in surveillance with these patients. … This is one of the major reasons for doing total body photograph."

Patients who receive copies of their photos, and are asked to do monthly self-exams, are more likely to do the exams and be effective in doing so, said Dr. Allan C. Halpern. Daphne Demas/MSKCC Dermatology

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New Findings on Chronic Urticaria Refine Screening, Improve Outcomes

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SAN ANTONIO — Treatment of chronic urticaria can be challenging, but recent findings on the condition may help improve outcomes, Dr. Aniko Kobza Black reported at the annual meeting of the American Academy of Dermatology.

One new advance is the usefulness of the autologous serum skin test (ASST) in screening for autoimmune urticaria, even though positivity can persist after clearing in autoimmune urticaria. With other types of urticaria, the test becomes negative as the condition improves and resolves.

Another recent finding is the association between a positive ASST and multiple drug sensitivities in patients with acute urticaria, said Dr. Black of St. John's Institute of Dermatology, St. Thomas Hospital, London.

Yet another new finding related to the ASST “may have practical implications.” Dr. Black explained that by using plasma rather than serum in the test, the positive test rate can be increased from 55% to 86% in patients with chronic urticaria. “There is an additional factor in plasma that induces histamine release, and it's now been shown that in chronic urticaria, there is increased thrombin formation. Thrombin can activate mast cells, so the modulation of the coagulation system with anticoagulants may prove useful in therapy for urticaria.”

The role of Helicobacter pylori in chronic urticaria is controversial. About 40% of patients have abdominal symptoms, but no evidence shows H. pylori infection causes the condition. It may be that it plays an indirect role in genetically predisposed individuals, but this remains unclear.

First-line treatment for chronic urticaria remains low-sedation antihistamines. The use of doses above recommended levels remains controversial—it seems to be clinically effective in some patients, but no trials have shown efficacy with the approach.

In rare cases, antihistamines may actually aggravate urticaria. Allergic reactions can occur in minutes but usually occur after 6 hours, and they have been seen with each type of antihistamine. No definite cause is known, but the reactions may be the result of a direct effect on mast cells.

When deciding on treatment, first consider possible side effects, then ease of administration, and then cost, she advised.

It is not possible to predict which treatments will be effective in a given patient. When first-line antihistamine treatments and combinations aren't adequate, it is important to reassess disease severity, patient history, and ASST status before trying the second- and third-line treatments because of the risk of side effects. All three types of treatments can be combined, however, “and indeed they usually have to be,” Dr. Black said.

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SAN ANTONIO — Treatment of chronic urticaria can be challenging, but recent findings on the condition may help improve outcomes, Dr. Aniko Kobza Black reported at the annual meeting of the American Academy of Dermatology.

One new advance is the usefulness of the autologous serum skin test (ASST) in screening for autoimmune urticaria, even though positivity can persist after clearing in autoimmune urticaria. With other types of urticaria, the test becomes negative as the condition improves and resolves.

Another recent finding is the association between a positive ASST and multiple drug sensitivities in patients with acute urticaria, said Dr. Black of St. John's Institute of Dermatology, St. Thomas Hospital, London.

Yet another new finding related to the ASST “may have practical implications.” Dr. Black explained that by using plasma rather than serum in the test, the positive test rate can be increased from 55% to 86% in patients with chronic urticaria. “There is an additional factor in plasma that induces histamine release, and it's now been shown that in chronic urticaria, there is increased thrombin formation. Thrombin can activate mast cells, so the modulation of the coagulation system with anticoagulants may prove useful in therapy for urticaria.”

The role of Helicobacter pylori in chronic urticaria is controversial. About 40% of patients have abdominal symptoms, but no evidence shows H. pylori infection causes the condition. It may be that it plays an indirect role in genetically predisposed individuals, but this remains unclear.

First-line treatment for chronic urticaria remains low-sedation antihistamines. The use of doses above recommended levels remains controversial—it seems to be clinically effective in some patients, but no trials have shown efficacy with the approach.

In rare cases, antihistamines may actually aggravate urticaria. Allergic reactions can occur in minutes but usually occur after 6 hours, and they have been seen with each type of antihistamine. No definite cause is known, but the reactions may be the result of a direct effect on mast cells.

When deciding on treatment, first consider possible side effects, then ease of administration, and then cost, she advised.

It is not possible to predict which treatments will be effective in a given patient. When first-line antihistamine treatments and combinations aren't adequate, it is important to reassess disease severity, patient history, and ASST status before trying the second- and third-line treatments because of the risk of side effects. All three types of treatments can be combined, however, “and indeed they usually have to be,” Dr. Black said.

SAN ANTONIO — Treatment of chronic urticaria can be challenging, but recent findings on the condition may help improve outcomes, Dr. Aniko Kobza Black reported at the annual meeting of the American Academy of Dermatology.

One new advance is the usefulness of the autologous serum skin test (ASST) in screening for autoimmune urticaria, even though positivity can persist after clearing in autoimmune urticaria. With other types of urticaria, the test becomes negative as the condition improves and resolves.

Another recent finding is the association between a positive ASST and multiple drug sensitivities in patients with acute urticaria, said Dr. Black of St. John's Institute of Dermatology, St. Thomas Hospital, London.

Yet another new finding related to the ASST “may have practical implications.” Dr. Black explained that by using plasma rather than serum in the test, the positive test rate can be increased from 55% to 86% in patients with chronic urticaria. “There is an additional factor in plasma that induces histamine release, and it's now been shown that in chronic urticaria, there is increased thrombin formation. Thrombin can activate mast cells, so the modulation of the coagulation system with anticoagulants may prove useful in therapy for urticaria.”

The role of Helicobacter pylori in chronic urticaria is controversial. About 40% of patients have abdominal symptoms, but no evidence shows H. pylori infection causes the condition. It may be that it plays an indirect role in genetically predisposed individuals, but this remains unclear.

First-line treatment for chronic urticaria remains low-sedation antihistamines. The use of doses above recommended levels remains controversial—it seems to be clinically effective in some patients, but no trials have shown efficacy with the approach.

In rare cases, antihistamines may actually aggravate urticaria. Allergic reactions can occur in minutes but usually occur after 6 hours, and they have been seen with each type of antihistamine. No definite cause is known, but the reactions may be the result of a direct effect on mast cells.

When deciding on treatment, first consider possible side effects, then ease of administration, and then cost, she advised.

It is not possible to predict which treatments will be effective in a given patient. When first-line antihistamine treatments and combinations aren't adequate, it is important to reassess disease severity, patient history, and ASST status before trying the second- and third-line treatments because of the risk of side effects. All three types of treatments can be combined, however, “and indeed they usually have to be,” Dr. Black said.

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Long-Term Adalimumab Safe, Effective in PsA

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SAN ANTONIO – Adalimumab proved safe and effective when used for up to 2 years for the treatment of psoriatic arthritis in a phase III open-label extension study, according to results reported at the annual meeting of the American Academy of Dermatology.

In 395 patients who completed 2 years of treatment with adalimumab (Humira) for the 120-week multinational trial, treatment showed rapid efficacy for psoriatic arthritis (PsA), and the effect was sustained through the duration of the study, said Dr. Philip Mease of the Swedish Medical Center in Seattle.

Among the measures used in the study to assess disease signs and symptoms were the American College of Rheumatology's ACR 20, ACR 50, and ACR 70 response rates, and the Psoriatic Arthritis Response Criteria (PsARC). The percentages of PsARC responders at weeks 48 and 104 were 77% and 81%, respectively, Dr. Mease reported.

Psoriasis disease activity was measured in those with at least a 3% body surface area involvement using the Psoriasis Activity Severity Index (PASI) 50, 75, and 90 and the Physician's Global Assessment of Psoriasis.

The percentage of patients achieving PASI 50, 75, and 90 scores at weeks 48 and 104 were 84%, 69%, and 55%; and 83%, 70%, and 53%, respectively, Dr. Mease said during a poster discussion at the conference. The percentages of patients with a Physician's Global Assessment of clear or almost clear at those time points were 38% and 30%, and 40% and 31%, respectively.

Patients in the study, which was funded by Abbott Laboratories, were participants in either the 24-week Adalimumab Effectiveness in Psoriatic Arthritis Trial or a similar 12-week trial of the drug. Both trials were placebo-controlled trials comparing placebo with 40 mg of adalimumab every other week, and both showed that adalimumab provided statistically and clinically significant improvement, compared with placebo.

Quality of life was also evaluated using a variety of measures. Among them was the Health Assessment Questionnaire, which measures disability. The mean change at both weeks 48 and 104 was −0.4, which surpassed the “minimum clinically important difference level” of −0.3, Dr. Mease noted.

As for safety, a total of 10.6 serious adverse events per 100 patient-years occurred during the course of the study. There were 2.4 serious infectious adverse events per 100 patient-years, 0.5 malignancies other than nonmelanoma skin cancer per 100 patient-years, 0.78 nonmelanoma skin cancers per 100 patient-years, and two deaths–neither of which was thought to be due to adalimumab treatment, Dr. Mease said. “Overall, the take-home message was that safety issues were similar to those in rheumatoid arthritis trials.” The current findings demonstrate that adalimumab is safe, efficacious, and well tolerated for both skin and joint manifestations through 2 years in patients with psoriatic arthritis, Dr. Mease said.

The agent safely controlled skin and joint symptoms in some patients through 2 years of use. DR. MEASE

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SAN ANTONIO – Adalimumab proved safe and effective when used for up to 2 years for the treatment of psoriatic arthritis in a phase III open-label extension study, according to results reported at the annual meeting of the American Academy of Dermatology.

In 395 patients who completed 2 years of treatment with adalimumab (Humira) for the 120-week multinational trial, treatment showed rapid efficacy for psoriatic arthritis (PsA), and the effect was sustained through the duration of the study, said Dr. Philip Mease of the Swedish Medical Center in Seattle.

Among the measures used in the study to assess disease signs and symptoms were the American College of Rheumatology's ACR 20, ACR 50, and ACR 70 response rates, and the Psoriatic Arthritis Response Criteria (PsARC). The percentages of PsARC responders at weeks 48 and 104 were 77% and 81%, respectively, Dr. Mease reported.

Psoriasis disease activity was measured in those with at least a 3% body surface area involvement using the Psoriasis Activity Severity Index (PASI) 50, 75, and 90 and the Physician's Global Assessment of Psoriasis.

The percentage of patients achieving PASI 50, 75, and 90 scores at weeks 48 and 104 were 84%, 69%, and 55%; and 83%, 70%, and 53%, respectively, Dr. Mease said during a poster discussion at the conference. The percentages of patients with a Physician's Global Assessment of clear or almost clear at those time points were 38% and 30%, and 40% and 31%, respectively.

Patients in the study, which was funded by Abbott Laboratories, were participants in either the 24-week Adalimumab Effectiveness in Psoriatic Arthritis Trial or a similar 12-week trial of the drug. Both trials were placebo-controlled trials comparing placebo with 40 mg of adalimumab every other week, and both showed that adalimumab provided statistically and clinically significant improvement, compared with placebo.

Quality of life was also evaluated using a variety of measures. Among them was the Health Assessment Questionnaire, which measures disability. The mean change at both weeks 48 and 104 was −0.4, which surpassed the “minimum clinically important difference level” of −0.3, Dr. Mease noted.

As for safety, a total of 10.6 serious adverse events per 100 patient-years occurred during the course of the study. There were 2.4 serious infectious adverse events per 100 patient-years, 0.5 malignancies other than nonmelanoma skin cancer per 100 patient-years, 0.78 nonmelanoma skin cancers per 100 patient-years, and two deaths–neither of which was thought to be due to adalimumab treatment, Dr. Mease said. “Overall, the take-home message was that safety issues were similar to those in rheumatoid arthritis trials.” The current findings demonstrate that adalimumab is safe, efficacious, and well tolerated for both skin and joint manifestations through 2 years in patients with psoriatic arthritis, Dr. Mease said.

The agent safely controlled skin and joint symptoms in some patients through 2 years of use. DR. MEASE

SAN ANTONIO – Adalimumab proved safe and effective when used for up to 2 years for the treatment of psoriatic arthritis in a phase III open-label extension study, according to results reported at the annual meeting of the American Academy of Dermatology.

In 395 patients who completed 2 years of treatment with adalimumab (Humira) for the 120-week multinational trial, treatment showed rapid efficacy for psoriatic arthritis (PsA), and the effect was sustained through the duration of the study, said Dr. Philip Mease of the Swedish Medical Center in Seattle.

Among the measures used in the study to assess disease signs and symptoms were the American College of Rheumatology's ACR 20, ACR 50, and ACR 70 response rates, and the Psoriatic Arthritis Response Criteria (PsARC). The percentages of PsARC responders at weeks 48 and 104 were 77% and 81%, respectively, Dr. Mease reported.

Psoriasis disease activity was measured in those with at least a 3% body surface area involvement using the Psoriasis Activity Severity Index (PASI) 50, 75, and 90 and the Physician's Global Assessment of Psoriasis.

The percentage of patients achieving PASI 50, 75, and 90 scores at weeks 48 and 104 were 84%, 69%, and 55%; and 83%, 70%, and 53%, respectively, Dr. Mease said during a poster discussion at the conference. The percentages of patients with a Physician's Global Assessment of clear or almost clear at those time points were 38% and 30%, and 40% and 31%, respectively.

Patients in the study, which was funded by Abbott Laboratories, were participants in either the 24-week Adalimumab Effectiveness in Psoriatic Arthritis Trial or a similar 12-week trial of the drug. Both trials were placebo-controlled trials comparing placebo with 40 mg of adalimumab every other week, and both showed that adalimumab provided statistically and clinically significant improvement, compared with placebo.

Quality of life was also evaluated using a variety of measures. Among them was the Health Assessment Questionnaire, which measures disability. The mean change at both weeks 48 and 104 was −0.4, which surpassed the “minimum clinically important difference level” of −0.3, Dr. Mease noted.

As for safety, a total of 10.6 serious adverse events per 100 patient-years occurred during the course of the study. There were 2.4 serious infectious adverse events per 100 patient-years, 0.5 malignancies other than nonmelanoma skin cancer per 100 patient-years, 0.78 nonmelanoma skin cancers per 100 patient-years, and two deaths–neither of which was thought to be due to adalimumab treatment, Dr. Mease said. “Overall, the take-home message was that safety issues were similar to those in rheumatoid arthritis trials.” The current findings demonstrate that adalimumab is safe, efficacious, and well tolerated for both skin and joint manifestations through 2 years in patients with psoriatic arthritis, Dr. Mease said.

The agent safely controlled skin and joint symptoms in some patients through 2 years of use. DR. MEASE

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Pediatric Programs Emphasize Lifestyle Changes

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Two programs developed by Children's Healthcare of Atlanta successfully promote healthier lifestyles in children, and one of the programs specifically targets prevention of type 2 diabetes.

Fit Kids is a program for overweight children aged 6–12 years and their families. Since 1996, more than 700 families have participated, with an overall class completion rate of 96%, and a high level of success as measured by 2-year follow-up surveys.

TIPPs is a newer program that incorporates exercise and nutrition education in an after-school diabetes prevention program for those aged 10–18 years who are overweight and at risk for type 2 diabetes.

The goal of the Fit Kids program is to address the escalating problem of obesity in the community by providing a comprehensive approach that engages the family, the community, and the medical community, and by providing children and families with the resources they need to overcome obesity, Dr. Seema Csukas, director of child health promotion for Children's Healthcare of Atlanta, a nonprofit pediatric health care system, said in an interview.

“The program was designed to address this struggle we are all having on how to deal with the obesity epidemic,” she said.

Fit Kids involves weekly 90-minute classes comprising a maximum of 12 families. Instructors help parents and children improve activity levels and nutrition with a focus on lifestyle rather than dieting, and they help families identify barriers to lifestyle changes. Other topics addressed during the 6-week program include body image, role modeling on the part of the parents, and hunger-fullness regulation. Each session includes 45 minutes of exercise.

Pre- and post-tests to assess changes in knowledge and behavior are completed by parents and children, and weekly goal sheets are completed to track completion of weekly family activities, consumption of fruits and vegetables, amount of sedentary screen time, number of family meals served, and number of sweetened beverages served. The 2-year follow-up surveys indicate that 97% of participating families serve fruits and vegetables with meals, 67% have increased physical activity levels, 58% have reduced screen time, and 98% offer milk or water with meals and snacks.

“What's nice about the program is that it's not about losing weight—it's about just doing things that are healthy and making good choices about what to eat,” Dr. Csukas said, adding that Fit Kids is good not only for the child, but for the whole family in terms of a lifestyle makeover.

Also, the physical activity aspect of the program isn't just about traditional exercise, but about walking, dancing, and just moving around, she said.

Similarly, TIPPs focuses on a lifestyle makeover, she said.

TIPPs participants undergo baseline labs, height and weight measurements, and fitness testing, and they complete an eating habit questionnaire. On the basis of the findings, individualized exercise and nutrition plans are developed. Participation requires twice weekly 45-minute exercise sessions.

The TIPPs program includes nutritional consultations and food demonstrations to model healthy eating, and also focuses on self-esteem issues. The ultimate goal is to prevent the onset of type 2 diabetes.

At 12 weeks, participants are reassessed, and healthy lifestyle goals are redefined.

In 2005–2006, 65% of participants completed the 12-week program. Of those, 78% decreased or stabilized body mass index, 61% decreased total cholesterol, 61% decreased LDL cholesterol, 54% increased HDL cholesterol, and 57% normalized or decreased fasting insulin.

The Fit Kid and TIPPs programs were among those honored recently with an Innovation in Prevention Award by the U.S. Department of Health and Human Services. The Innovation in Prevention Awards—part of President Bush's HealthierUS initiative and HHS's continuing focus on preventive health—recognize organizations that provide novel and creative chronic disease prevention and health promotion programs. Children's Healthcare of Atlanta received the initiative's Health Care Delivery System Award for the two programs.

In granting the Innovation in Prevention Awards, HHS hopes to increase public awareness and promote duplication of successful strategies like those developed by Children's Healthcare of Atlanta, according to an HHS statement.

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Two programs developed by Children's Healthcare of Atlanta successfully promote healthier lifestyles in children, and one of the programs specifically targets prevention of type 2 diabetes.

Fit Kids is a program for overweight children aged 6–12 years and their families. Since 1996, more than 700 families have participated, with an overall class completion rate of 96%, and a high level of success as measured by 2-year follow-up surveys.

TIPPs is a newer program that incorporates exercise and nutrition education in an after-school diabetes prevention program for those aged 10–18 years who are overweight and at risk for type 2 diabetes.

The goal of the Fit Kids program is to address the escalating problem of obesity in the community by providing a comprehensive approach that engages the family, the community, and the medical community, and by providing children and families with the resources they need to overcome obesity, Dr. Seema Csukas, director of child health promotion for Children's Healthcare of Atlanta, a nonprofit pediatric health care system, said in an interview.

“The program was designed to address this struggle we are all having on how to deal with the obesity epidemic,” she said.

Fit Kids involves weekly 90-minute classes comprising a maximum of 12 families. Instructors help parents and children improve activity levels and nutrition with a focus on lifestyle rather than dieting, and they help families identify barriers to lifestyle changes. Other topics addressed during the 6-week program include body image, role modeling on the part of the parents, and hunger-fullness regulation. Each session includes 45 minutes of exercise.

Pre- and post-tests to assess changes in knowledge and behavior are completed by parents and children, and weekly goal sheets are completed to track completion of weekly family activities, consumption of fruits and vegetables, amount of sedentary screen time, number of family meals served, and number of sweetened beverages served. The 2-year follow-up surveys indicate that 97% of participating families serve fruits and vegetables with meals, 67% have increased physical activity levels, 58% have reduced screen time, and 98% offer milk or water with meals and snacks.

“What's nice about the program is that it's not about losing weight—it's about just doing things that are healthy and making good choices about what to eat,” Dr. Csukas said, adding that Fit Kids is good not only for the child, but for the whole family in terms of a lifestyle makeover.

Also, the physical activity aspect of the program isn't just about traditional exercise, but about walking, dancing, and just moving around, she said.

Similarly, TIPPs focuses on a lifestyle makeover, she said.

TIPPs participants undergo baseline labs, height and weight measurements, and fitness testing, and they complete an eating habit questionnaire. On the basis of the findings, individualized exercise and nutrition plans are developed. Participation requires twice weekly 45-minute exercise sessions.

The TIPPs program includes nutritional consultations and food demonstrations to model healthy eating, and also focuses on self-esteem issues. The ultimate goal is to prevent the onset of type 2 diabetes.

At 12 weeks, participants are reassessed, and healthy lifestyle goals are redefined.

In 2005–2006, 65% of participants completed the 12-week program. Of those, 78% decreased or stabilized body mass index, 61% decreased total cholesterol, 61% decreased LDL cholesterol, 54% increased HDL cholesterol, and 57% normalized or decreased fasting insulin.

The Fit Kid and TIPPs programs were among those honored recently with an Innovation in Prevention Award by the U.S. Department of Health and Human Services. The Innovation in Prevention Awards—part of President Bush's HealthierUS initiative and HHS's continuing focus on preventive health—recognize organizations that provide novel and creative chronic disease prevention and health promotion programs. Children's Healthcare of Atlanta received the initiative's Health Care Delivery System Award for the two programs.

In granting the Innovation in Prevention Awards, HHS hopes to increase public awareness and promote duplication of successful strategies like those developed by Children's Healthcare of Atlanta, according to an HHS statement.

Two programs developed by Children's Healthcare of Atlanta successfully promote healthier lifestyles in children, and one of the programs specifically targets prevention of type 2 diabetes.

Fit Kids is a program for overweight children aged 6–12 years and their families. Since 1996, more than 700 families have participated, with an overall class completion rate of 96%, and a high level of success as measured by 2-year follow-up surveys.

TIPPs is a newer program that incorporates exercise and nutrition education in an after-school diabetes prevention program for those aged 10–18 years who are overweight and at risk for type 2 diabetes.

The goal of the Fit Kids program is to address the escalating problem of obesity in the community by providing a comprehensive approach that engages the family, the community, and the medical community, and by providing children and families with the resources they need to overcome obesity, Dr. Seema Csukas, director of child health promotion for Children's Healthcare of Atlanta, a nonprofit pediatric health care system, said in an interview.

“The program was designed to address this struggle we are all having on how to deal with the obesity epidemic,” she said.

Fit Kids involves weekly 90-minute classes comprising a maximum of 12 families. Instructors help parents and children improve activity levels and nutrition with a focus on lifestyle rather than dieting, and they help families identify barriers to lifestyle changes. Other topics addressed during the 6-week program include body image, role modeling on the part of the parents, and hunger-fullness regulation. Each session includes 45 minutes of exercise.

Pre- and post-tests to assess changes in knowledge and behavior are completed by parents and children, and weekly goal sheets are completed to track completion of weekly family activities, consumption of fruits and vegetables, amount of sedentary screen time, number of family meals served, and number of sweetened beverages served. The 2-year follow-up surveys indicate that 97% of participating families serve fruits and vegetables with meals, 67% have increased physical activity levels, 58% have reduced screen time, and 98% offer milk or water with meals and snacks.

“What's nice about the program is that it's not about losing weight—it's about just doing things that are healthy and making good choices about what to eat,” Dr. Csukas said, adding that Fit Kids is good not only for the child, but for the whole family in terms of a lifestyle makeover.

Also, the physical activity aspect of the program isn't just about traditional exercise, but about walking, dancing, and just moving around, she said.

Similarly, TIPPs focuses on a lifestyle makeover, she said.

TIPPs participants undergo baseline labs, height and weight measurements, and fitness testing, and they complete an eating habit questionnaire. On the basis of the findings, individualized exercise and nutrition plans are developed. Participation requires twice weekly 45-minute exercise sessions.

The TIPPs program includes nutritional consultations and food demonstrations to model healthy eating, and also focuses on self-esteem issues. The ultimate goal is to prevent the onset of type 2 diabetes.

At 12 weeks, participants are reassessed, and healthy lifestyle goals are redefined.

In 2005–2006, 65% of participants completed the 12-week program. Of those, 78% decreased or stabilized body mass index, 61% decreased total cholesterol, 61% decreased LDL cholesterol, 54% increased HDL cholesterol, and 57% normalized or decreased fasting insulin.

The Fit Kid and TIPPs programs were among those honored recently with an Innovation in Prevention Award by the U.S. Department of Health and Human Services. The Innovation in Prevention Awards—part of President Bush's HealthierUS initiative and HHS's continuing focus on preventive health—recognize organizations that provide novel and creative chronic disease prevention and health promotion programs. Children's Healthcare of Atlanta received the initiative's Health Care Delivery System Award for the two programs.

In granting the Innovation in Prevention Awards, HHS hopes to increase public awareness and promote duplication of successful strategies like those developed by Children's Healthcare of Atlanta, according to an HHS statement.

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Ustekinumab Aids Long-Term Control of Psoriasis

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SAN ANTONIO — Long-term, continuous use of ustekinumab for maintenance therapy in patients with moderate to severe plaque psoriasis is efficacious and generally well tolerated, according to phase III study findings reported at the annual meeting of the American Academy of Dermatology.

The results of the PHOENIX I trial, a randomized, double-blind, placebo-controlled crossover trial of the novel human monoclonal antibody against interleukins 12 and 23, showed treatment response was better maintained at 76 weeks in responders who received 45 mg or 90 mg of ustekinumab every 12 weeks, compared with those who stopped treatment at 40 weeks, Dr. Kenneth B. Gordon of Northwestern University, Chicago, said in a poster session.

The drug's maker (Centocor Inc.) announced last month that its Biologics License Application for ustekinumab (CNTO 1275) had been accepted for review by the Food and Drug Administration.

The results of another phase III study of the drug (PHOENIX II), reported in October at the World Congress of Dermatology in Buenos Aires, showed ustekinumab was effective and safe in more than two-thirds of 1,230 patients with moderate to severe disease who received two subcutaneous doses of the drug. A 75% improvement in the psoriasis severity area index score (PASI 75) was achieved in 67% of patients randomized to receive 45-mg doses, 76% of those randomized to receive 90-mg doses, and 4% of those in the placebo group.

For the current study, 766 patients were randomized to receive placebo or 45 mg or 90 mg of subcutaneous ustekinumab at weeks 0 and 4 of the study, and then every 12 weeks thereafter. At the 12-week mark, those in the placebo group crossed over to receive 45 mg or 90 mg of ustekinumab then and at week 16 and then every 12 weeks thereafter.

At 40 weeks, the 160 patients in the 45-mg treatment group from baseline and the 161 in the 90-mg treatment group from baseline who achieved a PASI 75 response at weeks 28 and 40 were further randomized to ongoing treatment or placebo every 12 weeks.

Of those in the ongoing treatment groups, 96% maintained at least a PASI 50 score through week 76, compared with just over 30% in the placebo groups; PASI 75 and 90 scores were also maintained in more patients in the ongoing treatment groups, compared with the placebo groups (see chart). At 40 weeks, about 75% of the 90-mg group had disease rated as cleared or minimal on the Physician's Global Assessment.

Maintenance therapy with ustekinumab was well tolerated in this study at both the 45-mg and 90-mg doses, and safety was “generally comparable” with that with interrupted therapy after 40 weeks in both groups, noted Dr. Gordon, who received research support for the study from Centocor. No cases of tuberculosis, anaphylactic or serum sickness-like reactions, or injection-site reactions occurred. The most common adverse events were upper respiratory tract infection, nasopharyngitis, arthralgia, and headache (see chart).

Patients in PHOENIX I were at least 18 years old, had been diagnosed with plaque psoriasis for at least 6 months (most had a disease duration of about 20 years), had a baseline PASI score of 12 or higher, and had at least 10% body surface area involvement. Those with nonplaque forms of psoriasis, with a recent serious systemic or chronic infection, a history of tuberculosis, or a known malignancy were excluded. Baseline disease characteristics were similar across the groups, with 23%–25% body surface area involvement and baseline PASI scores of 19–20 in all groups.

Baseline Dermatology Life Quality Index (DLQI) scores were 11 or 12 in all groups and improved markedly when the PASI 75 primary end point was reached. But in those switched from treatment to placebo in the randomized withdrawal phase, DLQI scores returned to baseline even in those whose PASI scores were above baseline. “This means when people get better, they don't want to get worse again,” Dr. Gordon said in an interview. “Even with clinical improvement … they are no longer tolerant of the amount of psoriasis they once had.”

The findings show that the drug might “control plaque psoriasis with as few as four injections a year,” he noted in a press statement. The drug targets different proteins involved in the inflammatory process and development of psoriasis. “The molecule attacks, binds to, and inactivates interleukin 12 and 23. The latter is important in activating the immune process and impacting the keratinocyte response, which are seen as the clinical manifestations of psoriasis.

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SAN ANTONIO — Long-term, continuous use of ustekinumab for maintenance therapy in patients with moderate to severe plaque psoriasis is efficacious and generally well tolerated, according to phase III study findings reported at the annual meeting of the American Academy of Dermatology.

The results of the PHOENIX I trial, a randomized, double-blind, placebo-controlled crossover trial of the novel human monoclonal antibody against interleukins 12 and 23, showed treatment response was better maintained at 76 weeks in responders who received 45 mg or 90 mg of ustekinumab every 12 weeks, compared with those who stopped treatment at 40 weeks, Dr. Kenneth B. Gordon of Northwestern University, Chicago, said in a poster session.

The drug's maker (Centocor Inc.) announced last month that its Biologics License Application for ustekinumab (CNTO 1275) had been accepted for review by the Food and Drug Administration.

The results of another phase III study of the drug (PHOENIX II), reported in October at the World Congress of Dermatology in Buenos Aires, showed ustekinumab was effective and safe in more than two-thirds of 1,230 patients with moderate to severe disease who received two subcutaneous doses of the drug. A 75% improvement in the psoriasis severity area index score (PASI 75) was achieved in 67% of patients randomized to receive 45-mg doses, 76% of those randomized to receive 90-mg doses, and 4% of those in the placebo group.

For the current study, 766 patients were randomized to receive placebo or 45 mg or 90 mg of subcutaneous ustekinumab at weeks 0 and 4 of the study, and then every 12 weeks thereafter. At the 12-week mark, those in the placebo group crossed over to receive 45 mg or 90 mg of ustekinumab then and at week 16 and then every 12 weeks thereafter.

At 40 weeks, the 160 patients in the 45-mg treatment group from baseline and the 161 in the 90-mg treatment group from baseline who achieved a PASI 75 response at weeks 28 and 40 were further randomized to ongoing treatment or placebo every 12 weeks.

Of those in the ongoing treatment groups, 96% maintained at least a PASI 50 score through week 76, compared with just over 30% in the placebo groups; PASI 75 and 90 scores were also maintained in more patients in the ongoing treatment groups, compared with the placebo groups (see chart). At 40 weeks, about 75% of the 90-mg group had disease rated as cleared or minimal on the Physician's Global Assessment.

Maintenance therapy with ustekinumab was well tolerated in this study at both the 45-mg and 90-mg doses, and safety was “generally comparable” with that with interrupted therapy after 40 weeks in both groups, noted Dr. Gordon, who received research support for the study from Centocor. No cases of tuberculosis, anaphylactic or serum sickness-like reactions, or injection-site reactions occurred. The most common adverse events were upper respiratory tract infection, nasopharyngitis, arthralgia, and headache (see chart).

Patients in PHOENIX I were at least 18 years old, had been diagnosed with plaque psoriasis for at least 6 months (most had a disease duration of about 20 years), had a baseline PASI score of 12 or higher, and had at least 10% body surface area involvement. Those with nonplaque forms of psoriasis, with a recent serious systemic or chronic infection, a history of tuberculosis, or a known malignancy were excluded. Baseline disease characteristics were similar across the groups, with 23%–25% body surface area involvement and baseline PASI scores of 19–20 in all groups.

Baseline Dermatology Life Quality Index (DLQI) scores were 11 or 12 in all groups and improved markedly when the PASI 75 primary end point was reached. But in those switched from treatment to placebo in the randomized withdrawal phase, DLQI scores returned to baseline even in those whose PASI scores were above baseline. “This means when people get better, they don't want to get worse again,” Dr. Gordon said in an interview. “Even with clinical improvement … they are no longer tolerant of the amount of psoriasis they once had.”

The findings show that the drug might “control plaque psoriasis with as few as four injections a year,” he noted in a press statement. The drug targets different proteins involved in the inflammatory process and development of psoriasis. “The molecule attacks, binds to, and inactivates interleukin 12 and 23. The latter is important in activating the immune process and impacting the keratinocyte response, which are seen as the clinical manifestations of psoriasis.

ELSEVIER GLOBAL MEDICAL NEWS

 

 

ELSEVIER GLOBAL MEDICAL NEWS

SAN ANTONIO — Long-term, continuous use of ustekinumab for maintenance therapy in patients with moderate to severe plaque psoriasis is efficacious and generally well tolerated, according to phase III study findings reported at the annual meeting of the American Academy of Dermatology.

The results of the PHOENIX I trial, a randomized, double-blind, placebo-controlled crossover trial of the novel human monoclonal antibody against interleukins 12 and 23, showed treatment response was better maintained at 76 weeks in responders who received 45 mg or 90 mg of ustekinumab every 12 weeks, compared with those who stopped treatment at 40 weeks, Dr. Kenneth B. Gordon of Northwestern University, Chicago, said in a poster session.

The drug's maker (Centocor Inc.) announced last month that its Biologics License Application for ustekinumab (CNTO 1275) had been accepted for review by the Food and Drug Administration.

The results of another phase III study of the drug (PHOENIX II), reported in October at the World Congress of Dermatology in Buenos Aires, showed ustekinumab was effective and safe in more than two-thirds of 1,230 patients with moderate to severe disease who received two subcutaneous doses of the drug. A 75% improvement in the psoriasis severity area index score (PASI 75) was achieved in 67% of patients randomized to receive 45-mg doses, 76% of those randomized to receive 90-mg doses, and 4% of those in the placebo group.

For the current study, 766 patients were randomized to receive placebo or 45 mg or 90 mg of subcutaneous ustekinumab at weeks 0 and 4 of the study, and then every 12 weeks thereafter. At the 12-week mark, those in the placebo group crossed over to receive 45 mg or 90 mg of ustekinumab then and at week 16 and then every 12 weeks thereafter.

At 40 weeks, the 160 patients in the 45-mg treatment group from baseline and the 161 in the 90-mg treatment group from baseline who achieved a PASI 75 response at weeks 28 and 40 were further randomized to ongoing treatment or placebo every 12 weeks.

Of those in the ongoing treatment groups, 96% maintained at least a PASI 50 score through week 76, compared with just over 30% in the placebo groups; PASI 75 and 90 scores were also maintained in more patients in the ongoing treatment groups, compared with the placebo groups (see chart). At 40 weeks, about 75% of the 90-mg group had disease rated as cleared or minimal on the Physician's Global Assessment.

Maintenance therapy with ustekinumab was well tolerated in this study at both the 45-mg and 90-mg doses, and safety was “generally comparable” with that with interrupted therapy after 40 weeks in both groups, noted Dr. Gordon, who received research support for the study from Centocor. No cases of tuberculosis, anaphylactic or serum sickness-like reactions, or injection-site reactions occurred. The most common adverse events were upper respiratory tract infection, nasopharyngitis, arthralgia, and headache (see chart).

Patients in PHOENIX I were at least 18 years old, had been diagnosed with plaque psoriasis for at least 6 months (most had a disease duration of about 20 years), had a baseline PASI score of 12 or higher, and had at least 10% body surface area involvement. Those with nonplaque forms of psoriasis, with a recent serious systemic or chronic infection, a history of tuberculosis, or a known malignancy were excluded. Baseline disease characteristics were similar across the groups, with 23%–25% body surface area involvement and baseline PASI scores of 19–20 in all groups.

Baseline Dermatology Life Quality Index (DLQI) scores were 11 or 12 in all groups and improved markedly when the PASI 75 primary end point was reached. But in those switched from treatment to placebo in the randomized withdrawal phase, DLQI scores returned to baseline even in those whose PASI scores were above baseline. “This means when people get better, they don't want to get worse again,” Dr. Gordon said in an interview. “Even with clinical improvement … they are no longer tolerant of the amount of psoriasis they once had.”

The findings show that the drug might “control plaque psoriasis with as few as four injections a year,” he noted in a press statement. The drug targets different proteins involved in the inflammatory process and development of psoriasis. “The molecule attacks, binds to, and inactivates interleukin 12 and 23. The latter is important in activating the immune process and impacting the keratinocyte response, which are seen as the clinical manifestations of psoriasis.

ELSEVIER GLOBAL MEDICAL NEWS

 

 

ELSEVIER GLOBAL MEDICAL NEWS

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Melanoma Incidence in Children Is On the Rise

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ORLANDO — Cancer already kills more children aged 1–14 years than does any other disease, and the incidence of childhood melanoma in the United States is on the rise, Dr. Jane M. Grant-Kels said at the annual meeting of the Florida Society of Dermatologic Surgeons.

A 2007 study showed that melanoma accounts for up to 3% of all pediatric malignancies, including about 2% of malignancies in those aged younger than 20 years, and 0.3%–0.4% of malignancies in prepubertal children. The study also showed that melanoma diagnoses are seven times more common between the ages of 10 and 20 years than between 0 and 10 years (J. Clin. Oncol. 2007;25:1363–8).

The National Cancer Institute's Surveillance Epidemiology and End Results database showed an increased incidence of nearly 3% a year during 1985–2003 in those aged 1–19 years. Yet there remains a lack of awareness of the prevalence of melanoma in children. Those who believe that children don't get melanoma are doing their patients an injustice, and such thinking is largely to blame for the fact that diagnosis and treatment are delayed in 40% of childhood melanoma cases, said Dr. Grant-Kels, professor and chair of the dermatology department at the University of Connecticut Health Center, Farmington.

A review of 13 melanoma cases in children younger than age 17 years showed that 85% of the cancers were nodular in type and had a mean thickness of 3.2 mm when diagnosed; 5-year survival was a mean of 59% in the children (J. Am. Acad. Dermatol. 2005;53:816–22). “The lack of awareness and reluctance to diagnose pediatric melanoma can lead to higher incidence of thick melanomas,” wrote the authors.

In another study, a decrease in survival in up to 60% of cases was secondary to a delay in diagnosis attributable to lack of familiarity with pediatric melanoma, lack of vigilance in looking for melanoma in children, and lack of suspicion of melanoma in children.

In light of these findings, it is important to keep in mind that, although melanoma behaves similarly in adolescents and adults, this is not the case in prepubertal children, Dr. Grant-Kels noted.

In one study, melanoma in 33 children aged 14 years and younger was found to be amelanotic in half of the cases. Lesions were raised and resembled pyogenic granuloma in 73% of cases, and they were nodular in type in 27% of cases with a median thickness of 2.5 mm. Most were Clark IV-V lesions. Overall survival at 5 years was about 70% (Pediatrics 2005;115:649–54).

It also is important to keep in mind that childhood melanoma occurs most often in white patients, with only 6.5% of cases occurring in nonwhites, which is a higher percentage than seen in adults. Also, unlike adults, there is a higher predominance of cases in females, with 56%–61% of pediatric cases occurring in girls.

In one study of data from 3,158 patients in the National Cancer Data Base, that figure was 56% in those aged 1–19 years. There was a 90% female predominance among those older than age 10 years, whereas males and nonwhite patients predominated among those younger than age 10 with melanoma (J. Clin. Oncol. 2007;25:1363–8).

That study also showed that younger children tend to present more often with head and neck cancers: Of those aged 1–4 years, 39% presented with head and neck cancers, compared with 12% of those aged 5–19 years. Younger children in the study also were more likely to present with regional and distant metastases and to have poorer survival.

Other studies suggest that the incidence of melanoma is increasing at a faster rate in girls aged 10–19 years than among boys in that age group, which may reflect the popularity of tanning beds among girls, Dr. Grant-Kels suggested.

Some clinical findings that should prompt concern about possible melanoma in children younger than 12 years include a rapid increase in lesion size, bleeding, change in lesion color, nodular growth, pruritus, and lymphadenopathy. In children, 20% of cases occur on the head and neck, and 80% occur on the trunk or extremities, she said.

However, half of melanomas in children arise de novo. About a third arise from congenital melanocytic nevi, and about 20% arise from other melanocytic nevi, including dysplastic nevi, Dr. Grant-Kels said, noting the importantance of having a dermatopathologist review all specimens from pediatric patients.

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ORLANDO — Cancer already kills more children aged 1–14 years than does any other disease, and the incidence of childhood melanoma in the United States is on the rise, Dr. Jane M. Grant-Kels said at the annual meeting of the Florida Society of Dermatologic Surgeons.

A 2007 study showed that melanoma accounts for up to 3% of all pediatric malignancies, including about 2% of malignancies in those aged younger than 20 years, and 0.3%–0.4% of malignancies in prepubertal children. The study also showed that melanoma diagnoses are seven times more common between the ages of 10 and 20 years than between 0 and 10 years (J. Clin. Oncol. 2007;25:1363–8).

The National Cancer Institute's Surveillance Epidemiology and End Results database showed an increased incidence of nearly 3% a year during 1985–2003 in those aged 1–19 years. Yet there remains a lack of awareness of the prevalence of melanoma in children. Those who believe that children don't get melanoma are doing their patients an injustice, and such thinking is largely to blame for the fact that diagnosis and treatment are delayed in 40% of childhood melanoma cases, said Dr. Grant-Kels, professor and chair of the dermatology department at the University of Connecticut Health Center, Farmington.

A review of 13 melanoma cases in children younger than age 17 years showed that 85% of the cancers were nodular in type and had a mean thickness of 3.2 mm when diagnosed; 5-year survival was a mean of 59% in the children (J. Am. Acad. Dermatol. 2005;53:816–22). “The lack of awareness and reluctance to diagnose pediatric melanoma can lead to higher incidence of thick melanomas,” wrote the authors.

In another study, a decrease in survival in up to 60% of cases was secondary to a delay in diagnosis attributable to lack of familiarity with pediatric melanoma, lack of vigilance in looking for melanoma in children, and lack of suspicion of melanoma in children.

In light of these findings, it is important to keep in mind that, although melanoma behaves similarly in adolescents and adults, this is not the case in prepubertal children, Dr. Grant-Kels noted.

In one study, melanoma in 33 children aged 14 years and younger was found to be amelanotic in half of the cases. Lesions were raised and resembled pyogenic granuloma in 73% of cases, and they were nodular in type in 27% of cases with a median thickness of 2.5 mm. Most were Clark IV-V lesions. Overall survival at 5 years was about 70% (Pediatrics 2005;115:649–54).

It also is important to keep in mind that childhood melanoma occurs most often in white patients, with only 6.5% of cases occurring in nonwhites, which is a higher percentage than seen in adults. Also, unlike adults, there is a higher predominance of cases in females, with 56%–61% of pediatric cases occurring in girls.

In one study of data from 3,158 patients in the National Cancer Data Base, that figure was 56% in those aged 1–19 years. There was a 90% female predominance among those older than age 10 years, whereas males and nonwhite patients predominated among those younger than age 10 with melanoma (J. Clin. Oncol. 2007;25:1363–8).

That study also showed that younger children tend to present more often with head and neck cancers: Of those aged 1–4 years, 39% presented with head and neck cancers, compared with 12% of those aged 5–19 years. Younger children in the study also were more likely to present with regional and distant metastases and to have poorer survival.

Other studies suggest that the incidence of melanoma is increasing at a faster rate in girls aged 10–19 years than among boys in that age group, which may reflect the popularity of tanning beds among girls, Dr. Grant-Kels suggested.

Some clinical findings that should prompt concern about possible melanoma in children younger than 12 years include a rapid increase in lesion size, bleeding, change in lesion color, nodular growth, pruritus, and lymphadenopathy. In children, 20% of cases occur on the head and neck, and 80% occur on the trunk or extremities, she said.

However, half of melanomas in children arise de novo. About a third arise from congenital melanocytic nevi, and about 20% arise from other melanocytic nevi, including dysplastic nevi, Dr. Grant-Kels said, noting the importantance of having a dermatopathologist review all specimens from pediatric patients.

ORLANDO — Cancer already kills more children aged 1–14 years than does any other disease, and the incidence of childhood melanoma in the United States is on the rise, Dr. Jane M. Grant-Kels said at the annual meeting of the Florida Society of Dermatologic Surgeons.

A 2007 study showed that melanoma accounts for up to 3% of all pediatric malignancies, including about 2% of malignancies in those aged younger than 20 years, and 0.3%–0.4% of malignancies in prepubertal children. The study also showed that melanoma diagnoses are seven times more common between the ages of 10 and 20 years than between 0 and 10 years (J. Clin. Oncol. 2007;25:1363–8).

The National Cancer Institute's Surveillance Epidemiology and End Results database showed an increased incidence of nearly 3% a year during 1985–2003 in those aged 1–19 years. Yet there remains a lack of awareness of the prevalence of melanoma in children. Those who believe that children don't get melanoma are doing their patients an injustice, and such thinking is largely to blame for the fact that diagnosis and treatment are delayed in 40% of childhood melanoma cases, said Dr. Grant-Kels, professor and chair of the dermatology department at the University of Connecticut Health Center, Farmington.

A review of 13 melanoma cases in children younger than age 17 years showed that 85% of the cancers were nodular in type and had a mean thickness of 3.2 mm when diagnosed; 5-year survival was a mean of 59% in the children (J. Am. Acad. Dermatol. 2005;53:816–22). “The lack of awareness and reluctance to diagnose pediatric melanoma can lead to higher incidence of thick melanomas,” wrote the authors.

In another study, a decrease in survival in up to 60% of cases was secondary to a delay in diagnosis attributable to lack of familiarity with pediatric melanoma, lack of vigilance in looking for melanoma in children, and lack of suspicion of melanoma in children.

In light of these findings, it is important to keep in mind that, although melanoma behaves similarly in adolescents and adults, this is not the case in prepubertal children, Dr. Grant-Kels noted.

In one study, melanoma in 33 children aged 14 years and younger was found to be amelanotic in half of the cases. Lesions were raised and resembled pyogenic granuloma in 73% of cases, and they were nodular in type in 27% of cases with a median thickness of 2.5 mm. Most were Clark IV-V lesions. Overall survival at 5 years was about 70% (Pediatrics 2005;115:649–54).

It also is important to keep in mind that childhood melanoma occurs most often in white patients, with only 6.5% of cases occurring in nonwhites, which is a higher percentage than seen in adults. Also, unlike adults, there is a higher predominance of cases in females, with 56%–61% of pediatric cases occurring in girls.

In one study of data from 3,158 patients in the National Cancer Data Base, that figure was 56% in those aged 1–19 years. There was a 90% female predominance among those older than age 10 years, whereas males and nonwhite patients predominated among those younger than age 10 with melanoma (J. Clin. Oncol. 2007;25:1363–8).

That study also showed that younger children tend to present more often with head and neck cancers: Of those aged 1–4 years, 39% presented with head and neck cancers, compared with 12% of those aged 5–19 years. Younger children in the study also were more likely to present with regional and distant metastases and to have poorer survival.

Other studies suggest that the incidence of melanoma is increasing at a faster rate in girls aged 10–19 years than among boys in that age group, which may reflect the popularity of tanning beds among girls, Dr. Grant-Kels suggested.

Some clinical findings that should prompt concern about possible melanoma in children younger than 12 years include a rapid increase in lesion size, bleeding, change in lesion color, nodular growth, pruritus, and lymphadenopathy. In children, 20% of cases occur on the head and neck, and 80% occur on the trunk or extremities, she said.

However, half of melanomas in children arise de novo. About a third arise from congenital melanocytic nevi, and about 20% arise from other melanocytic nevi, including dysplastic nevi, Dr. Grant-Kels said, noting the importantance of having a dermatopathologist review all specimens from pediatric patients.

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Women, Families With Children Need Sleep Education

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NEW ORLEANS – Mothers of young children aren't likely to be surprised by a recent study showing that they are more sleep deprived than are their male partners and women without children, but the findings are important because they underscore the need for sleep education in families with children, the investigators said.

Dr. Daniel P. Chapman and his colleagues at the Centers for Disease Control and Prevention in Atlanta used data from the 2002 Behavioral Risk Factor Surveillance System (BRFSS) for the study, which included 72,576 adult participants from the ongoing, state-based, random-digit dialing survey of community-based adults.

Married women with children were significantly more likely than were married men to report insufficient sleep (34% vs. 27%), and both married women and married men with children were more likely than were their married, gender-matched counterparts without children to report insufficient sleep (34% vs. 21%, and 27% vs. 16%, respectively).

The same was true among unmarried women with and without children (36% vs. 27%), and for unmarried men with and without children (31% vs. 25%), Dr. Chapman reported in a poster at the American Psychiatric Association's Institute on Psychiatric Services.

Of note, married women without children reported significantly more sleep insufficiency than did married men without children (21% vs. 16%), but the same did not hold true for unmarried women and men, who reported similar rates of sleep insufficiency (27% and 25%, respectively).

The findings indicate that sleep insufficiency is more prevalent in households with children and among women with children, compared with their partners, Dr. Chapman noted. “These findings suggest the need for sleep education among families with children–particularly for mothers–and corroborate the importance of sleep as a facet of women's health,” he concluded.

Respondents in this study were considered to have insufficient sleep if they reported feeling that they did not get enough sleep on 14 or more of the 30 days prior to the survey. The survey was conducted in 18 states and the District of Columbia.

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NEW ORLEANS – Mothers of young children aren't likely to be surprised by a recent study showing that they are more sleep deprived than are their male partners and women without children, but the findings are important because they underscore the need for sleep education in families with children, the investigators said.

Dr. Daniel P. Chapman and his colleagues at the Centers for Disease Control and Prevention in Atlanta used data from the 2002 Behavioral Risk Factor Surveillance System (BRFSS) for the study, which included 72,576 adult participants from the ongoing, state-based, random-digit dialing survey of community-based adults.

Married women with children were significantly more likely than were married men to report insufficient sleep (34% vs. 27%), and both married women and married men with children were more likely than were their married, gender-matched counterparts without children to report insufficient sleep (34% vs. 21%, and 27% vs. 16%, respectively).

The same was true among unmarried women with and without children (36% vs. 27%), and for unmarried men with and without children (31% vs. 25%), Dr. Chapman reported in a poster at the American Psychiatric Association's Institute on Psychiatric Services.

Of note, married women without children reported significantly more sleep insufficiency than did married men without children (21% vs. 16%), but the same did not hold true for unmarried women and men, who reported similar rates of sleep insufficiency (27% and 25%, respectively).

The findings indicate that sleep insufficiency is more prevalent in households with children and among women with children, compared with their partners, Dr. Chapman noted. “These findings suggest the need for sleep education among families with children–particularly for mothers–and corroborate the importance of sleep as a facet of women's health,” he concluded.

Respondents in this study were considered to have insufficient sleep if they reported feeling that they did not get enough sleep on 14 or more of the 30 days prior to the survey. The survey was conducted in 18 states and the District of Columbia.

NEW ORLEANS – Mothers of young children aren't likely to be surprised by a recent study showing that they are more sleep deprived than are their male partners and women without children, but the findings are important because they underscore the need for sleep education in families with children, the investigators said.

Dr. Daniel P. Chapman and his colleagues at the Centers for Disease Control and Prevention in Atlanta used data from the 2002 Behavioral Risk Factor Surveillance System (BRFSS) for the study, which included 72,576 adult participants from the ongoing, state-based, random-digit dialing survey of community-based adults.

Married women with children were significantly more likely than were married men to report insufficient sleep (34% vs. 27%), and both married women and married men with children were more likely than were their married, gender-matched counterparts without children to report insufficient sleep (34% vs. 21%, and 27% vs. 16%, respectively).

The same was true among unmarried women with and without children (36% vs. 27%), and for unmarried men with and without children (31% vs. 25%), Dr. Chapman reported in a poster at the American Psychiatric Association's Institute on Psychiatric Services.

Of note, married women without children reported significantly more sleep insufficiency than did married men without children (21% vs. 16%), but the same did not hold true for unmarried women and men, who reported similar rates of sleep insufficiency (27% and 25%, respectively).

The findings indicate that sleep insufficiency is more prevalent in households with children and among women with children, compared with their partners, Dr. Chapman noted. “These findings suggest the need for sleep education among families with children–particularly for mothers–and corroborate the importance of sleep as a facet of women's health,” he concluded.

Respondents in this study were considered to have insufficient sleep if they reported feeling that they did not get enough sleep on 14 or more of the 30 days prior to the survey. The survey was conducted in 18 states and the District of Columbia.

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Risk-Benefit Favorable for New Oral Psoriasis Tx

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SAN ANTONIO — A novel oral therapy with broad anti-inflammatory activity is showing promise for the treatment of moderate to severe plaque psoriasis, according to phase II study data presented at the annual meeting of the American Academy of Dermatology.

Apremilast (CC-10004, Celgene Corp.) is a phosphodiesterase type 4 inhibitor that has potent anti-inflammatory activity believed to result in part from inhibition of tumor necrosis factor-α and other proinflammatory mediators, including interleukin-2, interferon-α, leukotrienes, and nitric oxide synthase, Dr. Kim Papp of Probity Medical Research Inc., Waterloo, Ont., explained during a poster discussion session.

A group of 260 patients was enrolled in the randomized, controlled, 12-week trial, which compared once- and twice-daily 20-mg dosages of Apremilast with placebo. The study was supported by Celgene.

At week 12 of treatment, a significantly higher proportion of patients in the twice-daily treatment group achieved Psoriasis Activity and Severity Index-75 (PASI-75) scores, compared with the other groups (24% in the twice-daily treatment group versus 10% in the once-daily treatment and placebo groups). Similarly, PASI-50 scores were achieved by 57% of those in the twice-daily treatment group, 28% in the once-daily group, and 23% in the placebo group.

PASI-90 scores were achieved by 14% of patients in the twice-daily group, by 2% in the once-daily group, and by 6% in the placebo group, Dr. Papp said.

As for Dermatology Life Quality Index scores, the mean changes from baseline were 7 points among those treated twice daily, 5 points among those treated once daily, and 3 points among given placebo, he noted.

Patients in the treatment groups continued to show improvement over time, with the greatest mean percent reduction in PASI scores demonstrated at the final assessment at 12 weeks, he said.

Adverse events in the study were generally mild and were similar in all three groups. Fifty-four percent in the twice-daily treatment group, 68% in the once-daily group, and 60% in the placebo group reported at least one adverse event. Headache and nasopharyngitis were the most common adverse events in all three groups, followed by diarrhea, pruritus, fatigue, aggravated psoriasis, and nausea.

The participants in this phase II study were at least 18 years old, had a diagnosis of moderate to severe plaque psoriasis for at least 6 months prior to enrollment (but were otherwise in good health), had PASI scores of at least 10 and body surface area involvement of at least 10%, and were candidates for photo- or systemic therapy.

The findings demonstrate a favorable risk-benefit profile for Apremilast, Dr. Papp said.

"Current therapies are limited by toxicities or by lack of efficacy," he said, noting that very few available treatments are effective across the spectrum of psoriatic disease.

"We continue to seek novel and safe therapies for chronic plaque psoriasis … and this is the first [phosphodiesterase type 4 inhibitor] that has shown itself to be well tolerated, safe, and effective," he said.

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SAN ANTONIO — A novel oral therapy with broad anti-inflammatory activity is showing promise for the treatment of moderate to severe plaque psoriasis, according to phase II study data presented at the annual meeting of the American Academy of Dermatology.

Apremilast (CC-10004, Celgene Corp.) is a phosphodiesterase type 4 inhibitor that has potent anti-inflammatory activity believed to result in part from inhibition of tumor necrosis factor-α and other proinflammatory mediators, including interleukin-2, interferon-α, leukotrienes, and nitric oxide synthase, Dr. Kim Papp of Probity Medical Research Inc., Waterloo, Ont., explained during a poster discussion session.

A group of 260 patients was enrolled in the randomized, controlled, 12-week trial, which compared once- and twice-daily 20-mg dosages of Apremilast with placebo. The study was supported by Celgene.

At week 12 of treatment, a significantly higher proportion of patients in the twice-daily treatment group achieved Psoriasis Activity and Severity Index-75 (PASI-75) scores, compared with the other groups (24% in the twice-daily treatment group versus 10% in the once-daily treatment and placebo groups). Similarly, PASI-50 scores were achieved by 57% of those in the twice-daily treatment group, 28% in the once-daily group, and 23% in the placebo group.

PASI-90 scores were achieved by 14% of patients in the twice-daily group, by 2% in the once-daily group, and by 6% in the placebo group, Dr. Papp said.

As for Dermatology Life Quality Index scores, the mean changes from baseline were 7 points among those treated twice daily, 5 points among those treated once daily, and 3 points among given placebo, he noted.

Patients in the treatment groups continued to show improvement over time, with the greatest mean percent reduction in PASI scores demonstrated at the final assessment at 12 weeks, he said.

Adverse events in the study were generally mild and were similar in all three groups. Fifty-four percent in the twice-daily treatment group, 68% in the once-daily group, and 60% in the placebo group reported at least one adverse event. Headache and nasopharyngitis were the most common adverse events in all three groups, followed by diarrhea, pruritus, fatigue, aggravated psoriasis, and nausea.

The participants in this phase II study were at least 18 years old, had a diagnosis of moderate to severe plaque psoriasis for at least 6 months prior to enrollment (but were otherwise in good health), had PASI scores of at least 10 and body surface area involvement of at least 10%, and were candidates for photo- or systemic therapy.

The findings demonstrate a favorable risk-benefit profile for Apremilast, Dr. Papp said.

"Current therapies are limited by toxicities or by lack of efficacy," he said, noting that very few available treatments are effective across the spectrum of psoriatic disease.

"We continue to seek novel and safe therapies for chronic plaque psoriasis … and this is the first [phosphodiesterase type 4 inhibitor] that has shown itself to be well tolerated, safe, and effective," he said.

SAN ANTONIO — A novel oral therapy with broad anti-inflammatory activity is showing promise for the treatment of moderate to severe plaque psoriasis, according to phase II study data presented at the annual meeting of the American Academy of Dermatology.

Apremilast (CC-10004, Celgene Corp.) is a phosphodiesterase type 4 inhibitor that has potent anti-inflammatory activity believed to result in part from inhibition of tumor necrosis factor-α and other proinflammatory mediators, including interleukin-2, interferon-α, leukotrienes, and nitric oxide synthase, Dr. Kim Papp of Probity Medical Research Inc., Waterloo, Ont., explained during a poster discussion session.

A group of 260 patients was enrolled in the randomized, controlled, 12-week trial, which compared once- and twice-daily 20-mg dosages of Apremilast with placebo. The study was supported by Celgene.

At week 12 of treatment, a significantly higher proportion of patients in the twice-daily treatment group achieved Psoriasis Activity and Severity Index-75 (PASI-75) scores, compared with the other groups (24% in the twice-daily treatment group versus 10% in the once-daily treatment and placebo groups). Similarly, PASI-50 scores were achieved by 57% of those in the twice-daily treatment group, 28% in the once-daily group, and 23% in the placebo group.

PASI-90 scores were achieved by 14% of patients in the twice-daily group, by 2% in the once-daily group, and by 6% in the placebo group, Dr. Papp said.

As for Dermatology Life Quality Index scores, the mean changes from baseline were 7 points among those treated twice daily, 5 points among those treated once daily, and 3 points among given placebo, he noted.

Patients in the treatment groups continued to show improvement over time, with the greatest mean percent reduction in PASI scores demonstrated at the final assessment at 12 weeks, he said.

Adverse events in the study were generally mild and were similar in all three groups. Fifty-four percent in the twice-daily treatment group, 68% in the once-daily group, and 60% in the placebo group reported at least one adverse event. Headache and nasopharyngitis were the most common adverse events in all three groups, followed by diarrhea, pruritus, fatigue, aggravated psoriasis, and nausea.

The participants in this phase II study were at least 18 years old, had a diagnosis of moderate to severe plaque psoriasis for at least 6 months prior to enrollment (but were otherwise in good health), had PASI scores of at least 10 and body surface area involvement of at least 10%, and were candidates for photo- or systemic therapy.

The findings demonstrate a favorable risk-benefit profile for Apremilast, Dr. Papp said.

"Current therapies are limited by toxicities or by lack of efficacy," he said, noting that very few available treatments are effective across the spectrum of psoriatic disease.

"We continue to seek novel and safe therapies for chronic plaque psoriasis … and this is the first [phosphodiesterase type 4 inhibitor] that has shown itself to be well tolerated, safe, and effective," he said.

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