Fighting back against psoriasis bullies

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Dallas dermatologist Alan Menter, MD, doesn’t boast bullying-prevention superpowers, but what he does have is close enough: An eagerness to get the word out to anyone – parent or principal, psychologist or pediatrician – who can help prevent a child with psoriasis from being bullied.

Over his long career, Dr. Menter has made many calls to adults in positions of influence over children. “I’ve talked to pediatricians, and I’ve even called up schools and talked to principals to try get the bullying situation reduced to an extent where the kids can live happy, normal lives without kids taunting them.”

Dr. Menter, chief of dermatology at Baylor University in Dallas, has plenty of company. Other dermatologists are paying close attention to their youngest patients with psoriasis as researchers work to get a better handle on the bullying problem.

Dr. Alan Menter
For this story, Dr. Menter and two other experts talked to Dermatology News about the bullying problem and how dermatologists who treat children with psoriasis can make a difference.

“We really want to identify this early on and do whatever is required to turn it around,” said Amy Paller, MD, professor of dermatology and pediatrics and chair of the department of dermatology at Northwestern University, Chicago. “These visible skin lesions can have a very significant effect on how children feel about themselves and others. When this is going on early in life, during childhood or teen years, there’s really a risk for lifelong issues.”

Dr. Menter’s interest in psoriasis and bullying began during his childhood in South Africa when he watched children bully his brother, who had the condition. “I’ve always had a great desire to improve the quality of life in psoriasis patients,” he said, and that passion grew as he worked in a day care center for children with psoriasis. “I had an opportunity to talk to children and recognize the impact that psoriasis has on them.”

Research from across the world reveals that children with psoriasis face an extraordinary burden from bullying. “They’re teased incessantly and bullied because they’ve got such a visible disease,” he said.

The introspective and depressed nature of many children with psoriasis makes the situation even more difficult, he noted, since their emotional makeup prevents them from responding easily to taunting.

The extent of the bullying problem, however, isn’t fully understood. Research into bullying and skin disorders is “very limited,” said Kelly Cordoro, MD, of the departments of dermatology and pediatrics at the University of California, San Francisco. “What little evidence does exist suggests that kids with visible skin disease, including psoriasis, are often bullied, and this can impact them significantly,” she said, pointing to a 2013 study that suggested those with acne, psoriasis, and atopic dermatitis are especially vulnerable (Clin Dermatol. 2013;31[1]:66-71).

Dr. Kelly Cordoro
Dr. Cordoro said her patients have taught her that recurrent themes in bullying are name-calling, teasing, and social exclusion. “Kids with psoriasis may be told they look ‘disgusting’ and ‘gross’ and that others are afraid to play with them because they think they are contagious,” she said. “Kids are not invited to birthday parties, pool parties, and other group events because of the appearance of their skin.”

Sports are a special area of concern. “They don’t want to get into gym shorts, and they don’t want to engage in sports because they get hot and itchy,” Dr. Paller said. “Or people stay away from them because they think there’s something they can catch, so they’re not chosen for sports activities.”

Indeed, children with psoriasis may be left out of games like tag and contact sports because other children are afraid of touching them, Dr. Cordoro observed. “Other kids do not want to be near them. It is truly heartbreaking and derives largely from ignorance.”

What can dermatologists do? Dr. Cordoro recommends that they take time to ask their youngest patients about their lives: “Is your psoriasis affecting your friendships?” “How are things going at school?” “Do kids ask you about your psoriasis? What do you say?”

“We can identify at-risk kids this way and work with parents, schools, coaches, and counselors towards productive interventions like educational programs,” Dr. Cordoro said. “Education is the key. As kids, parents, and adults become educated, the psoriatic child is less likely to be teased and excluded. Kids with psoriasis may lack the confidence to defend themselves, and arming them with one-liners and basic educational points about their condition empowers them to address it directly.”

Dr. Paller, who is also director of the Northwestern University Skin Disease Research Center, said it’s a good idea to add questions to the usual list of queries about subjects like sleep and itching. In cases when a child is bullied, it may help to reach out to teachers and principals, and to counselors and social workers if needed, she noted.

Parents play an important role, too, Dr. Menter said, although they may be in the dark about bullying. “What I’ve learned is that kids will seldom come home and tell their parent they’ve been bullied.”

He urges both children and their parents to understand the nature of psoriasis and be open about it. “Don’t hide it,” he suggested. “Tell people that ‘I’ve got psoriasis, and it’s not contagious.’ ” And then, hopefully, the healing can begin.

Dr. Paller and Dr. Cordoro reported no relevant disclosures. Dr. Menter disclosed relationships with many pharmaceutical companies, including AbbVie, Allergan, Amgen, Boehringer Ingelheim, Eli Lilly, Merck, Novartis and Pfizer.
 
 

 

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Dallas dermatologist Alan Menter, MD, doesn’t boast bullying-prevention superpowers, but what he does have is close enough: An eagerness to get the word out to anyone – parent or principal, psychologist or pediatrician – who can help prevent a child with psoriasis from being bullied.

Over his long career, Dr. Menter has made many calls to adults in positions of influence over children. “I’ve talked to pediatricians, and I’ve even called up schools and talked to principals to try get the bullying situation reduced to an extent where the kids can live happy, normal lives without kids taunting them.”

Dr. Menter, chief of dermatology at Baylor University in Dallas, has plenty of company. Other dermatologists are paying close attention to their youngest patients with psoriasis as researchers work to get a better handle on the bullying problem.

Dr. Alan Menter
For this story, Dr. Menter and two other experts talked to Dermatology News about the bullying problem and how dermatologists who treat children with psoriasis can make a difference.

“We really want to identify this early on and do whatever is required to turn it around,” said Amy Paller, MD, professor of dermatology and pediatrics and chair of the department of dermatology at Northwestern University, Chicago. “These visible skin lesions can have a very significant effect on how children feel about themselves and others. When this is going on early in life, during childhood or teen years, there’s really a risk for lifelong issues.”

Dr. Menter’s interest in psoriasis and bullying began during his childhood in South Africa when he watched children bully his brother, who had the condition. “I’ve always had a great desire to improve the quality of life in psoriasis patients,” he said, and that passion grew as he worked in a day care center for children with psoriasis. “I had an opportunity to talk to children and recognize the impact that psoriasis has on them.”

Research from across the world reveals that children with psoriasis face an extraordinary burden from bullying. “They’re teased incessantly and bullied because they’ve got such a visible disease,” he said.

The introspective and depressed nature of many children with psoriasis makes the situation even more difficult, he noted, since their emotional makeup prevents them from responding easily to taunting.

The extent of the bullying problem, however, isn’t fully understood. Research into bullying and skin disorders is “very limited,” said Kelly Cordoro, MD, of the departments of dermatology and pediatrics at the University of California, San Francisco. “What little evidence does exist suggests that kids with visible skin disease, including psoriasis, are often bullied, and this can impact them significantly,” she said, pointing to a 2013 study that suggested those with acne, psoriasis, and atopic dermatitis are especially vulnerable (Clin Dermatol. 2013;31[1]:66-71).

Dr. Kelly Cordoro
Dr. Cordoro said her patients have taught her that recurrent themes in bullying are name-calling, teasing, and social exclusion. “Kids with psoriasis may be told they look ‘disgusting’ and ‘gross’ and that others are afraid to play with them because they think they are contagious,” she said. “Kids are not invited to birthday parties, pool parties, and other group events because of the appearance of their skin.”

Sports are a special area of concern. “They don’t want to get into gym shorts, and they don’t want to engage in sports because they get hot and itchy,” Dr. Paller said. “Or people stay away from them because they think there’s something they can catch, so they’re not chosen for sports activities.”

Indeed, children with psoriasis may be left out of games like tag and contact sports because other children are afraid of touching them, Dr. Cordoro observed. “Other kids do not want to be near them. It is truly heartbreaking and derives largely from ignorance.”

What can dermatologists do? Dr. Cordoro recommends that they take time to ask their youngest patients about their lives: “Is your psoriasis affecting your friendships?” “How are things going at school?” “Do kids ask you about your psoriasis? What do you say?”

“We can identify at-risk kids this way and work with parents, schools, coaches, and counselors towards productive interventions like educational programs,” Dr. Cordoro said. “Education is the key. As kids, parents, and adults become educated, the psoriatic child is less likely to be teased and excluded. Kids with psoriasis may lack the confidence to defend themselves, and arming them with one-liners and basic educational points about their condition empowers them to address it directly.”

Dr. Paller, who is also director of the Northwestern University Skin Disease Research Center, said it’s a good idea to add questions to the usual list of queries about subjects like sleep and itching. In cases when a child is bullied, it may help to reach out to teachers and principals, and to counselors and social workers if needed, she noted.

Parents play an important role, too, Dr. Menter said, although they may be in the dark about bullying. “What I’ve learned is that kids will seldom come home and tell their parent they’ve been bullied.”

He urges both children and their parents to understand the nature of psoriasis and be open about it. “Don’t hide it,” he suggested. “Tell people that ‘I’ve got psoriasis, and it’s not contagious.’ ” And then, hopefully, the healing can begin.

Dr. Paller and Dr. Cordoro reported no relevant disclosures. Dr. Menter disclosed relationships with many pharmaceutical companies, including AbbVie, Allergan, Amgen, Boehringer Ingelheim, Eli Lilly, Merck, Novartis and Pfizer.
 
 

 

 

Dallas dermatologist Alan Menter, MD, doesn’t boast bullying-prevention superpowers, but what he does have is close enough: An eagerness to get the word out to anyone – parent or principal, psychologist or pediatrician – who can help prevent a child with psoriasis from being bullied.

Over his long career, Dr. Menter has made many calls to adults in positions of influence over children. “I’ve talked to pediatricians, and I’ve even called up schools and talked to principals to try get the bullying situation reduced to an extent where the kids can live happy, normal lives without kids taunting them.”

Dr. Menter, chief of dermatology at Baylor University in Dallas, has plenty of company. Other dermatologists are paying close attention to their youngest patients with psoriasis as researchers work to get a better handle on the bullying problem.

Dr. Alan Menter
For this story, Dr. Menter and two other experts talked to Dermatology News about the bullying problem and how dermatologists who treat children with psoriasis can make a difference.

“We really want to identify this early on and do whatever is required to turn it around,” said Amy Paller, MD, professor of dermatology and pediatrics and chair of the department of dermatology at Northwestern University, Chicago. “These visible skin lesions can have a very significant effect on how children feel about themselves and others. When this is going on early in life, during childhood or teen years, there’s really a risk for lifelong issues.”

Dr. Menter’s interest in psoriasis and bullying began during his childhood in South Africa when he watched children bully his brother, who had the condition. “I’ve always had a great desire to improve the quality of life in psoriasis patients,” he said, and that passion grew as he worked in a day care center for children with psoriasis. “I had an opportunity to talk to children and recognize the impact that psoriasis has on them.”

Research from across the world reveals that children with psoriasis face an extraordinary burden from bullying. “They’re teased incessantly and bullied because they’ve got such a visible disease,” he said.

The introspective and depressed nature of many children with psoriasis makes the situation even more difficult, he noted, since their emotional makeup prevents them from responding easily to taunting.

The extent of the bullying problem, however, isn’t fully understood. Research into bullying and skin disorders is “very limited,” said Kelly Cordoro, MD, of the departments of dermatology and pediatrics at the University of California, San Francisco. “What little evidence does exist suggests that kids with visible skin disease, including psoriasis, are often bullied, and this can impact them significantly,” she said, pointing to a 2013 study that suggested those with acne, psoriasis, and atopic dermatitis are especially vulnerable (Clin Dermatol. 2013;31[1]:66-71).

Dr. Kelly Cordoro
Dr. Cordoro said her patients have taught her that recurrent themes in bullying are name-calling, teasing, and social exclusion. “Kids with psoriasis may be told they look ‘disgusting’ and ‘gross’ and that others are afraid to play with them because they think they are contagious,” she said. “Kids are not invited to birthday parties, pool parties, and other group events because of the appearance of their skin.”

Sports are a special area of concern. “They don’t want to get into gym shorts, and they don’t want to engage in sports because they get hot and itchy,” Dr. Paller said. “Or people stay away from them because they think there’s something they can catch, so they’re not chosen for sports activities.”

Indeed, children with psoriasis may be left out of games like tag and contact sports because other children are afraid of touching them, Dr. Cordoro observed. “Other kids do not want to be near them. It is truly heartbreaking and derives largely from ignorance.”

What can dermatologists do? Dr. Cordoro recommends that they take time to ask their youngest patients about their lives: “Is your psoriasis affecting your friendships?” “How are things going at school?” “Do kids ask you about your psoriasis? What do you say?”

“We can identify at-risk kids this way and work with parents, schools, coaches, and counselors towards productive interventions like educational programs,” Dr. Cordoro said. “Education is the key. As kids, parents, and adults become educated, the psoriatic child is less likely to be teased and excluded. Kids with psoriasis may lack the confidence to defend themselves, and arming them with one-liners and basic educational points about their condition empowers them to address it directly.”

Dr. Paller, who is also director of the Northwestern University Skin Disease Research Center, said it’s a good idea to add questions to the usual list of queries about subjects like sleep and itching. In cases when a child is bullied, it may help to reach out to teachers and principals, and to counselors and social workers if needed, she noted.

Parents play an important role, too, Dr. Menter said, although they may be in the dark about bullying. “What I’ve learned is that kids will seldom come home and tell their parent they’ve been bullied.”

He urges both children and their parents to understand the nature of psoriasis and be open about it. “Don’t hide it,” he suggested. “Tell people that ‘I’ve got psoriasis, and it’s not contagious.’ ” And then, hopefully, the healing can begin.

Dr. Paller and Dr. Cordoro reported no relevant disclosures. Dr. Menter disclosed relationships with many pharmaceutical companies, including AbbVie, Allergan, Amgen, Boehringer Ingelheim, Eli Lilly, Merck, Novartis and Pfizer.
 
 

 

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Cystic fibrosis–related diabetes requires unique treatment

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SAN DIEGO – Long-term cystic fibrosis survivors are prone to a singular form of diabetes, according to Katie Larson Ode, MD.

Medical advances have dramatically boosted life expectancy for people with cystic fibrosis, allowing some to survive into middle age. “As more of our patients live longer, [cystic fibrosis–related diabetes (CFRD)] will become a much more common problem for endocrinologists, educators, nurses, and nutritionists to address,” said Dr. Ode, a pediatrician at the University of Iowa in Iowa City. “Proper management of cystic fibrosis-related diabetes is lifesaving for our CF patients.”

Dr. Katie Larson Ode
An estimated 30,000 people in the United States have cystic fibrosis; half of them are over 18 years old, according to the Cystic Fibrosis Foundation.

“CF is caused by a defect in an important chloride channel that regulates the salt and water content of secretions,” said Antoinette Moran, MD, professor and division chief of pediatric endocrinology and diabetes at the University of Minnesota, Minneapolis, while speaking at the annual meeting of the American Association of Diabetes Educators. “This affects many organs, but death is generally due to chronic obstructive lung disease.”
 

In the 1950s, few children with CF lived past elementary school age. Now, researchers estimate that the median life span for babies born and diagnosed in 2010 could reach more than 50 years (Ann Intern Med. 2014 Aug 19;161[4]:233-41), according to the Cystic Fibrosis Foundation.

But as they age, CF patients’ risk for CFRD also increases.

A 2009 study led by Dr. Moran (Diabetes Care 2009 Sep;32[9]: 1626-31) tracked 872 CF patients from three periods in the 1990s and 2000s and found CFRD in 2% of children, 19% of adolescents, and 40%-50% of adults. “For a typical CF patient, the chances of developing CFRD by age 40 are roughly 80%,” said Andrew Norris, MD, PhD, of the departments of pediatrics and biochemistry at the University of Iowa.

Dr. Andrew Norris
CF patients who inherit a mild form of the disease often have less risk of CFRD. The condition is “primarily due to insulin insufficiency, caused by fibrotic destruction of islets and perhaps an intrinsic defect in beta-cell function related to the primary CF chloride–channel defect,” Dr. Moran said. “Up to 80% of CF patients with severe mutations will eventually develop diabetes.”

CF patients aren’t limited to one form of diabetes. “Occasionally a patient may be unlucky enough to have more than one type,” Dr. Moran said, since the diseases have separate pathophysiologies. While rare, type 1 appears to be more common than type 2, which is often linked to obesity; CF patients struggle to put on weight. “It would be highly unusual for a CF patient to develop type 2 diabetes,” Dr. Norris said.

The specialists said patients with CFRD are unique among diabetics for several reasons:

• Microvascular complications are rare. “After many years of diabetes, CFRD patients are at risk for microvascular complications, but they tend to be less common and less severe than in other forms of diabetes, likely because CF patients still make some of their own insulin,” Dr. Moran said.

• Macrovascular complications are not seen. “This is important because recommendations given to people with other forms of the diabetes to reduce risk of macrovascular complications – weight loss, low-fat diet, low-salt diet, etc.– do no apply in CF and can actually be harmful,” Dr. Moran said.

• Insulin is especially crucial. “Maintaining weight and lean body mass is critical for survival in CF, so the chief clinical concern with CFRD is nutrition and the potential impact of insulin insufficiency on mortality,” Dr. Moran said. “Insulin replacement is the only approved therapy for CFRD. Treatment is very similar to that of type 1 diabetic patients in a honeymoon state. Very early on, patients may receive a single dose of basal insulin only or of premeal rapid-acting insulin only. Eventually most CF patients require basal-bolus insulin therapy.”

Doses tend to be lower than in other diabetics, she said, “except for when CF patients are acutely ill. During acute illness, CF patients become insulin resistant and require high insulin doses.”

Still, “once I start insulin, my goal is to deliver as large a dose as the patient can safely tolerate, to maximize anabolic impact,” she said.

The physicians offered these tips about tracking and treating CF patients:

• Screen CF patients via oral glucose tolerance testing on an annual basis, starting no later than age 10. Don’t trust hemoglobin A1c levels or fasting glucose levels, Dr. Norris said, because they are not sensitive enough. In fact, Dr. Moran said, “HbA1cis spuriously low in CF. “Even mild diabetes can be immediately detrimental to a CF patient’s lung health and mortality risk,” Dr. Norris said. “If you wait until the onset of classic diabetes symptoms or until the fasting glucose or hemoglobin A1c is elevated, you will have done a great disservice to the CF patient, as preventable potentially life-threatening lung damage may have already occurred.”

• Check into your center’s testing protocol. “Unfortunately, current screening rates are markedly insufficient at many centers,” Dr. Norris said. “I encourage endocrine teams to reach out to their affiliated CF treatment center to discuss and help implement screening.”
 

 

What’s next? The University of Iowa’s Dr. Larson said he is hopeful about advances in medical care. “Currently, patients must follow an extremely complex regimen of airway clearance, inhaled antibiotics, and oral medications, typically with recurrent hospitalization with increasing age and eventual death from lung disease or lung transplant,” she said. “However, in the past few years, we have had a dramatic change for a percentage of our patients with the development of small molecules that can actually fix the chloride-channel defect itself.”

The treatment seems to arrest and even improve lung disease in eligible patients, she said. “So the future seems very bright for CF.”

The Cystic Fibrosis Foundation has developed a 3-year Envision program to train adult and pediatric endocrinologists in the care of CFRD and endocrine issues.

Dr. Moran had no relevant disclosures. Dr. Norris has consulted for Vertex Pharmaceuticals, which makes cystic fibrosis therapeutics, in the past year. Dr. Larson Ode reports that her research is funded by the National Institutes of Health and the Cystic Fibrosis Foundation.

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SAN DIEGO – Long-term cystic fibrosis survivors are prone to a singular form of diabetes, according to Katie Larson Ode, MD.

Medical advances have dramatically boosted life expectancy for people with cystic fibrosis, allowing some to survive into middle age. “As more of our patients live longer, [cystic fibrosis–related diabetes (CFRD)] will become a much more common problem for endocrinologists, educators, nurses, and nutritionists to address,” said Dr. Ode, a pediatrician at the University of Iowa in Iowa City. “Proper management of cystic fibrosis-related diabetes is lifesaving for our CF patients.”

Dr. Katie Larson Ode
An estimated 30,000 people in the United States have cystic fibrosis; half of them are over 18 years old, according to the Cystic Fibrosis Foundation.

“CF is caused by a defect in an important chloride channel that regulates the salt and water content of secretions,” said Antoinette Moran, MD, professor and division chief of pediatric endocrinology and diabetes at the University of Minnesota, Minneapolis, while speaking at the annual meeting of the American Association of Diabetes Educators. “This affects many organs, but death is generally due to chronic obstructive lung disease.”
 

In the 1950s, few children with CF lived past elementary school age. Now, researchers estimate that the median life span for babies born and diagnosed in 2010 could reach more than 50 years (Ann Intern Med. 2014 Aug 19;161[4]:233-41), according to the Cystic Fibrosis Foundation.

But as they age, CF patients’ risk for CFRD also increases.

A 2009 study led by Dr. Moran (Diabetes Care 2009 Sep;32[9]: 1626-31) tracked 872 CF patients from three periods in the 1990s and 2000s and found CFRD in 2% of children, 19% of adolescents, and 40%-50% of adults. “For a typical CF patient, the chances of developing CFRD by age 40 are roughly 80%,” said Andrew Norris, MD, PhD, of the departments of pediatrics and biochemistry at the University of Iowa.

Dr. Andrew Norris
CF patients who inherit a mild form of the disease often have less risk of CFRD. The condition is “primarily due to insulin insufficiency, caused by fibrotic destruction of islets and perhaps an intrinsic defect in beta-cell function related to the primary CF chloride–channel defect,” Dr. Moran said. “Up to 80% of CF patients with severe mutations will eventually develop diabetes.”

CF patients aren’t limited to one form of diabetes. “Occasionally a patient may be unlucky enough to have more than one type,” Dr. Moran said, since the diseases have separate pathophysiologies. While rare, type 1 appears to be more common than type 2, which is often linked to obesity; CF patients struggle to put on weight. “It would be highly unusual for a CF patient to develop type 2 diabetes,” Dr. Norris said.

The specialists said patients with CFRD are unique among diabetics for several reasons:

• Microvascular complications are rare. “After many years of diabetes, CFRD patients are at risk for microvascular complications, but they tend to be less common and less severe than in other forms of diabetes, likely because CF patients still make some of their own insulin,” Dr. Moran said.

• Macrovascular complications are not seen. “This is important because recommendations given to people with other forms of the diabetes to reduce risk of macrovascular complications – weight loss, low-fat diet, low-salt diet, etc.– do no apply in CF and can actually be harmful,” Dr. Moran said.

• Insulin is especially crucial. “Maintaining weight and lean body mass is critical for survival in CF, so the chief clinical concern with CFRD is nutrition and the potential impact of insulin insufficiency on mortality,” Dr. Moran said. “Insulin replacement is the only approved therapy for CFRD. Treatment is very similar to that of type 1 diabetic patients in a honeymoon state. Very early on, patients may receive a single dose of basal insulin only or of premeal rapid-acting insulin only. Eventually most CF patients require basal-bolus insulin therapy.”

Doses tend to be lower than in other diabetics, she said, “except for when CF patients are acutely ill. During acute illness, CF patients become insulin resistant and require high insulin doses.”

Still, “once I start insulin, my goal is to deliver as large a dose as the patient can safely tolerate, to maximize anabolic impact,” she said.

The physicians offered these tips about tracking and treating CF patients:

• Screen CF patients via oral glucose tolerance testing on an annual basis, starting no later than age 10. Don’t trust hemoglobin A1c levels or fasting glucose levels, Dr. Norris said, because they are not sensitive enough. In fact, Dr. Moran said, “HbA1cis spuriously low in CF. “Even mild diabetes can be immediately detrimental to a CF patient’s lung health and mortality risk,” Dr. Norris said. “If you wait until the onset of classic diabetes symptoms or until the fasting glucose or hemoglobin A1c is elevated, you will have done a great disservice to the CF patient, as preventable potentially life-threatening lung damage may have already occurred.”

• Check into your center’s testing protocol. “Unfortunately, current screening rates are markedly insufficient at many centers,” Dr. Norris said. “I encourage endocrine teams to reach out to their affiliated CF treatment center to discuss and help implement screening.”
 

 

What’s next? The University of Iowa’s Dr. Larson said he is hopeful about advances in medical care. “Currently, patients must follow an extremely complex regimen of airway clearance, inhaled antibiotics, and oral medications, typically with recurrent hospitalization with increasing age and eventual death from lung disease or lung transplant,” she said. “However, in the past few years, we have had a dramatic change for a percentage of our patients with the development of small molecules that can actually fix the chloride-channel defect itself.”

The treatment seems to arrest and even improve lung disease in eligible patients, she said. “So the future seems very bright for CF.”

The Cystic Fibrosis Foundation has developed a 3-year Envision program to train adult and pediatric endocrinologists in the care of CFRD and endocrine issues.

Dr. Moran had no relevant disclosures. Dr. Norris has consulted for Vertex Pharmaceuticals, which makes cystic fibrosis therapeutics, in the past year. Dr. Larson Ode reports that her research is funded by the National Institutes of Health and the Cystic Fibrosis Foundation.

SAN DIEGO – Long-term cystic fibrosis survivors are prone to a singular form of diabetes, according to Katie Larson Ode, MD.

Medical advances have dramatically boosted life expectancy for people with cystic fibrosis, allowing some to survive into middle age. “As more of our patients live longer, [cystic fibrosis–related diabetes (CFRD)] will become a much more common problem for endocrinologists, educators, nurses, and nutritionists to address,” said Dr. Ode, a pediatrician at the University of Iowa in Iowa City. “Proper management of cystic fibrosis-related diabetes is lifesaving for our CF patients.”

Dr. Katie Larson Ode
An estimated 30,000 people in the United States have cystic fibrosis; half of them are over 18 years old, according to the Cystic Fibrosis Foundation.

“CF is caused by a defect in an important chloride channel that regulates the salt and water content of secretions,” said Antoinette Moran, MD, professor and division chief of pediatric endocrinology and diabetes at the University of Minnesota, Minneapolis, while speaking at the annual meeting of the American Association of Diabetes Educators. “This affects many organs, but death is generally due to chronic obstructive lung disease.”
 

In the 1950s, few children with CF lived past elementary school age. Now, researchers estimate that the median life span for babies born and diagnosed in 2010 could reach more than 50 years (Ann Intern Med. 2014 Aug 19;161[4]:233-41), according to the Cystic Fibrosis Foundation.

But as they age, CF patients’ risk for CFRD also increases.

A 2009 study led by Dr. Moran (Diabetes Care 2009 Sep;32[9]: 1626-31) tracked 872 CF patients from three periods in the 1990s and 2000s and found CFRD in 2% of children, 19% of adolescents, and 40%-50% of adults. “For a typical CF patient, the chances of developing CFRD by age 40 are roughly 80%,” said Andrew Norris, MD, PhD, of the departments of pediatrics and biochemistry at the University of Iowa.

Dr. Andrew Norris
CF patients who inherit a mild form of the disease often have less risk of CFRD. The condition is “primarily due to insulin insufficiency, caused by fibrotic destruction of islets and perhaps an intrinsic defect in beta-cell function related to the primary CF chloride–channel defect,” Dr. Moran said. “Up to 80% of CF patients with severe mutations will eventually develop diabetes.”

CF patients aren’t limited to one form of diabetes. “Occasionally a patient may be unlucky enough to have more than one type,” Dr. Moran said, since the diseases have separate pathophysiologies. While rare, type 1 appears to be more common than type 2, which is often linked to obesity; CF patients struggle to put on weight. “It would be highly unusual for a CF patient to develop type 2 diabetes,” Dr. Norris said.

The specialists said patients with CFRD are unique among diabetics for several reasons:

• Microvascular complications are rare. “After many years of diabetes, CFRD patients are at risk for microvascular complications, but they tend to be less common and less severe than in other forms of diabetes, likely because CF patients still make some of their own insulin,” Dr. Moran said.

• Macrovascular complications are not seen. “This is important because recommendations given to people with other forms of the diabetes to reduce risk of macrovascular complications – weight loss, low-fat diet, low-salt diet, etc.– do no apply in CF and can actually be harmful,” Dr. Moran said.

• Insulin is especially crucial. “Maintaining weight and lean body mass is critical for survival in CF, so the chief clinical concern with CFRD is nutrition and the potential impact of insulin insufficiency on mortality,” Dr. Moran said. “Insulin replacement is the only approved therapy for CFRD. Treatment is very similar to that of type 1 diabetic patients in a honeymoon state. Very early on, patients may receive a single dose of basal insulin only or of premeal rapid-acting insulin only. Eventually most CF patients require basal-bolus insulin therapy.”

Doses tend to be lower than in other diabetics, she said, “except for when CF patients are acutely ill. During acute illness, CF patients become insulin resistant and require high insulin doses.”

Still, “once I start insulin, my goal is to deliver as large a dose as the patient can safely tolerate, to maximize anabolic impact,” she said.

The physicians offered these tips about tracking and treating CF patients:

• Screen CF patients via oral glucose tolerance testing on an annual basis, starting no later than age 10. Don’t trust hemoglobin A1c levels or fasting glucose levels, Dr. Norris said, because they are not sensitive enough. In fact, Dr. Moran said, “HbA1cis spuriously low in CF. “Even mild diabetes can be immediately detrimental to a CF patient’s lung health and mortality risk,” Dr. Norris said. “If you wait until the onset of classic diabetes symptoms or until the fasting glucose or hemoglobin A1c is elevated, you will have done a great disservice to the CF patient, as preventable potentially life-threatening lung damage may have already occurred.”

• Check into your center’s testing protocol. “Unfortunately, current screening rates are markedly insufficient at many centers,” Dr. Norris said. “I encourage endocrine teams to reach out to their affiliated CF treatment center to discuss and help implement screening.”
 

 

What’s next? The University of Iowa’s Dr. Larson said he is hopeful about advances in medical care. “Currently, patients must follow an extremely complex regimen of airway clearance, inhaled antibiotics, and oral medications, typically with recurrent hospitalization with increasing age and eventual death from lung disease or lung transplant,” she said. “However, in the past few years, we have had a dramatic change for a percentage of our patients with the development of small molecules that can actually fix the chloride-channel defect itself.”

The treatment seems to arrest and even improve lung disease in eligible patients, she said. “So the future seems very bright for CF.”

The Cystic Fibrosis Foundation has developed a 3-year Envision program to train adult and pediatric endocrinologists in the care of CFRD and endocrine issues.

Dr. Moran had no relevant disclosures. Dr. Norris has consulted for Vertex Pharmaceuticals, which makes cystic fibrosis therapeutics, in the past year. Dr. Larson Ode reports that her research is funded by the National Institutes of Health and the Cystic Fibrosis Foundation.

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EXPERT ANALYSIS FROM AADE 16 
 

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The eyelids have it: bug bites 101

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NEWPORT BEACH, CA. – Bed bugs rise when night falls. Drawn by the carbon dioxide of sleeping humans, they gather to feast, leaving bites galore.

But other insects dine on people, too. Telling their bites apart is an important – and sometimes difficult – job for dermatologists who treat children. Fortunately, there are clinical signs to look for, a pediatric dermatologist told an audience of colleagues, including one that she herself helped introduce.

It’s called the “Eyelid Sign,” a clinical clue, Andrea Zaenglein, MD, said at Skin Diseases Education Foundation’s Women & Pediatric Dermatology Seminar.

Dr. Andrea Zaenglein


Dr. Zaenglein, professor of dermatology and pediatric dermatology at Penn State University, Hershey, has often seen children with bites on their eyelids since they’re being bitten by bed bugs while they’re asleep. “You don’t get a lot of eyelid bites with other things,” she said. “Think about bed bugs whenever you see eyelid bites.”

She and a colleague reported on the “Eyelid Sign” in a study published in 2014, describing papules on the upper eyelid or eyelids associated with erythema and edema in six patients (Pediatr Dermatol. 2014 May-Jun;31[3]:353-5).

During her presentation, Dr. Zaenglein offered more tips on detecting bed bugs:

• Keep in mind that they’re probably not going to be sitting there under the pillow, waiting for your patients to find them. “They like to hide in nooks and crannies,” she said. “They don’t really stay in your bed.” Common hiding places include mattresses, floorboards, and wallpaper.

• Bed bugs are about the size of an apple seed. Stains and dark spots on bed sheets and mattresses can be signs of crushed bed bugs and bed bug excrement.

• They’re more common in urban areas, but “bed bugs are a problem in probably all of our communities,” Dr. Zaenglein noted.

• Some children can develop a reaction to bed bugs and other insects known as papular urticaria. “I have to explain to parents that this is a hypersensitivity response that’s abnormal,” Dr. Zaenglein said.

She noted that papular urticaria tends to be worse in summer and rarely involves the face. Treatments include antihistamines, strong topical steroids, and prevention of insect bites.

As for bed bug bites in general, the Centers for Disease Control and Prevention recommends antiseptic creams or lotions and antihistamine use.

How can bed bugs be killed off for good? The CDC suggests insecticide spraying to eliminate bed bugs, and states that “the best way to prevent bed bugs is regular inspection for the signs of an infestation.”

During the presentation, Dr. Zaenglein also spoke about scabies, focusing on the unique traits of the condition in babies.

“They always present with a lot of rash,” she said. “They won’t have a few papules on their hands and feet like older kids.” The rash will be “dirty-looking,” she continued, and more asymmetric than symmetric. Also, “you’ll almost always get a lot of mites burden if you scrape a baby,” she said. “It’s much harder to find a mite in older kids and young adults.”

Affected babies may be referred from an emergency department or primary care doctor with an incorrect diagnosis of eczema, she said, adding that scabies is extremely contagious. “If a baby has scabies,” she said, “you inevitably have to get your prescription pad. Treat all the household members.”

Babies may be itchy, but itchiness is much more common in older kids and young adults, keeping them up at night, she said. “College students come home over the break with a couple of papules on the belly, and they say it’s driving them crazy. They say it’s crazy, crazy itchy. If you hear that, think scabies.”

Another scabies clue in older kids: hand involvement. “Always look at the wrist, between the fingers. You get these generalized eruptions there.”

Scabies bites can be treated with a topical corticosteroid and, in children aged 2 months and older, permethrin 5% cream. Dr. Zaenglein said there’s concern about a leukemia risk associated with permethrin, but that applies to industrial use and overuse. Ivermectin is an alternative for stubborn and institutional cases.

As for prevention, she said pesticide sprays and fogs are generally discouraged. She advises families to wash recently used clothing and bedding in hot water. Clothing and bedding, including pillows, can also be stored in a closed plastic bag for up to a week.

“You could dry clean it all too,” she said, “but I’ll bet your dry cleaner won’t be too happy about it.”

Dr. Zaenglein disclosed serving as a consultant and researcher for Ranbaxy Laboratories Limited.

SDEF and this news organization are owned by the same parent company.

 

 

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NEWPORT BEACH, CA. – Bed bugs rise when night falls. Drawn by the carbon dioxide of sleeping humans, they gather to feast, leaving bites galore.

But other insects dine on people, too. Telling their bites apart is an important – and sometimes difficult – job for dermatologists who treat children. Fortunately, there are clinical signs to look for, a pediatric dermatologist told an audience of colleagues, including one that she herself helped introduce.

It’s called the “Eyelid Sign,” a clinical clue, Andrea Zaenglein, MD, said at Skin Diseases Education Foundation’s Women & Pediatric Dermatology Seminar.

Dr. Andrea Zaenglein


Dr. Zaenglein, professor of dermatology and pediatric dermatology at Penn State University, Hershey, has often seen children with bites on their eyelids since they’re being bitten by bed bugs while they’re asleep. “You don’t get a lot of eyelid bites with other things,” she said. “Think about bed bugs whenever you see eyelid bites.”

She and a colleague reported on the “Eyelid Sign” in a study published in 2014, describing papules on the upper eyelid or eyelids associated with erythema and edema in six patients (Pediatr Dermatol. 2014 May-Jun;31[3]:353-5).

During her presentation, Dr. Zaenglein offered more tips on detecting bed bugs:

• Keep in mind that they’re probably not going to be sitting there under the pillow, waiting for your patients to find them. “They like to hide in nooks and crannies,” she said. “They don’t really stay in your bed.” Common hiding places include mattresses, floorboards, and wallpaper.

• Bed bugs are about the size of an apple seed. Stains and dark spots on bed sheets and mattresses can be signs of crushed bed bugs and bed bug excrement.

• They’re more common in urban areas, but “bed bugs are a problem in probably all of our communities,” Dr. Zaenglein noted.

• Some children can develop a reaction to bed bugs and other insects known as papular urticaria. “I have to explain to parents that this is a hypersensitivity response that’s abnormal,” Dr. Zaenglein said.

She noted that papular urticaria tends to be worse in summer and rarely involves the face. Treatments include antihistamines, strong topical steroids, and prevention of insect bites.

As for bed bug bites in general, the Centers for Disease Control and Prevention recommends antiseptic creams or lotions and antihistamine use.

How can bed bugs be killed off for good? The CDC suggests insecticide spraying to eliminate bed bugs, and states that “the best way to prevent bed bugs is regular inspection for the signs of an infestation.”

During the presentation, Dr. Zaenglein also spoke about scabies, focusing on the unique traits of the condition in babies.

“They always present with a lot of rash,” she said. “They won’t have a few papules on their hands and feet like older kids.” The rash will be “dirty-looking,” she continued, and more asymmetric than symmetric. Also, “you’ll almost always get a lot of mites burden if you scrape a baby,” she said. “It’s much harder to find a mite in older kids and young adults.”

Affected babies may be referred from an emergency department or primary care doctor with an incorrect diagnosis of eczema, she said, adding that scabies is extremely contagious. “If a baby has scabies,” she said, “you inevitably have to get your prescription pad. Treat all the household members.”

Babies may be itchy, but itchiness is much more common in older kids and young adults, keeping them up at night, she said. “College students come home over the break with a couple of papules on the belly, and they say it’s driving them crazy. They say it’s crazy, crazy itchy. If you hear that, think scabies.”

Another scabies clue in older kids: hand involvement. “Always look at the wrist, between the fingers. You get these generalized eruptions there.”

Scabies bites can be treated with a topical corticosteroid and, in children aged 2 months and older, permethrin 5% cream. Dr. Zaenglein said there’s concern about a leukemia risk associated with permethrin, but that applies to industrial use and overuse. Ivermectin is an alternative for stubborn and institutional cases.

As for prevention, she said pesticide sprays and fogs are generally discouraged. She advises families to wash recently used clothing and bedding in hot water. Clothing and bedding, including pillows, can also be stored in a closed plastic bag for up to a week.

“You could dry clean it all too,” she said, “but I’ll bet your dry cleaner won’t be too happy about it.”

Dr. Zaenglein disclosed serving as a consultant and researcher for Ranbaxy Laboratories Limited.

SDEF and this news organization are owned by the same parent company.

 

 

 

NEWPORT BEACH, CA. – Bed bugs rise when night falls. Drawn by the carbon dioxide of sleeping humans, they gather to feast, leaving bites galore.

But other insects dine on people, too. Telling their bites apart is an important – and sometimes difficult – job for dermatologists who treat children. Fortunately, there are clinical signs to look for, a pediatric dermatologist told an audience of colleagues, including one that she herself helped introduce.

It’s called the “Eyelid Sign,” a clinical clue, Andrea Zaenglein, MD, said at Skin Diseases Education Foundation’s Women & Pediatric Dermatology Seminar.

Dr. Andrea Zaenglein


Dr. Zaenglein, professor of dermatology and pediatric dermatology at Penn State University, Hershey, has often seen children with bites on their eyelids since they’re being bitten by bed bugs while they’re asleep. “You don’t get a lot of eyelid bites with other things,” she said. “Think about bed bugs whenever you see eyelid bites.”

She and a colleague reported on the “Eyelid Sign” in a study published in 2014, describing papules on the upper eyelid or eyelids associated with erythema and edema in six patients (Pediatr Dermatol. 2014 May-Jun;31[3]:353-5).

During her presentation, Dr. Zaenglein offered more tips on detecting bed bugs:

• Keep in mind that they’re probably not going to be sitting there under the pillow, waiting for your patients to find them. “They like to hide in nooks and crannies,” she said. “They don’t really stay in your bed.” Common hiding places include mattresses, floorboards, and wallpaper.

• Bed bugs are about the size of an apple seed. Stains and dark spots on bed sheets and mattresses can be signs of crushed bed bugs and bed bug excrement.

• They’re more common in urban areas, but “bed bugs are a problem in probably all of our communities,” Dr. Zaenglein noted.

• Some children can develop a reaction to bed bugs and other insects known as papular urticaria. “I have to explain to parents that this is a hypersensitivity response that’s abnormal,” Dr. Zaenglein said.

She noted that papular urticaria tends to be worse in summer and rarely involves the face. Treatments include antihistamines, strong topical steroids, and prevention of insect bites.

As for bed bug bites in general, the Centers for Disease Control and Prevention recommends antiseptic creams or lotions and antihistamine use.

How can bed bugs be killed off for good? The CDC suggests insecticide spraying to eliminate bed bugs, and states that “the best way to prevent bed bugs is regular inspection for the signs of an infestation.”

During the presentation, Dr. Zaenglein also spoke about scabies, focusing on the unique traits of the condition in babies.

“They always present with a lot of rash,” she said. “They won’t have a few papules on their hands and feet like older kids.” The rash will be “dirty-looking,” she continued, and more asymmetric than symmetric. Also, “you’ll almost always get a lot of mites burden if you scrape a baby,” she said. “It’s much harder to find a mite in older kids and young adults.”

Affected babies may be referred from an emergency department or primary care doctor with an incorrect diagnosis of eczema, she said, adding that scabies is extremely contagious. “If a baby has scabies,” she said, “you inevitably have to get your prescription pad. Treat all the household members.”

Babies may be itchy, but itchiness is much more common in older kids and young adults, keeping them up at night, she said. “College students come home over the break with a couple of papules on the belly, and they say it’s driving them crazy. They say it’s crazy, crazy itchy. If you hear that, think scabies.”

Another scabies clue in older kids: hand involvement. “Always look at the wrist, between the fingers. You get these generalized eruptions there.”

Scabies bites can be treated with a topical corticosteroid and, in children aged 2 months and older, permethrin 5% cream. Dr. Zaenglein said there’s concern about a leukemia risk associated with permethrin, but that applies to industrial use and overuse. Ivermectin is an alternative for stubborn and institutional cases.

As for prevention, she said pesticide sprays and fogs are generally discouraged. She advises families to wash recently used clothing and bedding in hot water. Clothing and bedding, including pillows, can also be stored in a closed plastic bag for up to a week.

“You could dry clean it all too,” she said, “but I’ll bet your dry cleaner won’t be too happy about it.”

Dr. Zaenglein disclosed serving as a consultant and researcher for Ranbaxy Laboratories Limited.

SDEF and this news organization are owned by the same parent company.

 

 

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AT SDEF WOMEN'S & PEDIATRIC DERMATOLOGY SEMINAR

Disallow All Ads

Pharmacists: Weight-loss drugs and diabetes can mix

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Weight-loss medications have a role in the management of diabetes, as long as physicians and patients realize these drugs are not an easy fix.

In light of their side effects and other complications, weight-loss drugs haven’t reached their full diet-in-a-pill potential. Diet drugs remain controversial even as the Food and Drug Administration continues to approve new formulations. Such weight-loss medications can still play a role in the care of diabetic patient, according to a pair of diabetes educators.

 

The key, they say, is to understand the limits of their potential and their not-so-limited drawbacks. “There is no magic pill,” said Charmaine Rochester, PharmD, an associate professor of pharmacy with the University of Maryland School of Pharmacy, Baltimore. “Patients need to know that it is not an easy fix. They still have to change their lifestyles with the medications.”

Dr. Rochester and Lisa Meade, PharmD, CDE, an associate professor of pharmacy at Wingate (N.C.) University School of Pharmacy, spoke about weight loss medications and diabetes care at the annual meeting of the American Association of Diabetes Educators and in later interviews.

These medications produce weight loss in the 5%-10% range. Still, “weight loss as little as 5% can significantly improve glycemic control, and modest weight loss of 5% to under 10% has been associated with significant improvements in cardiovascular disease risk factors at 1 year – decreased inflammation, improvement in insulin resistance, improved blood pressure, and improved cholesterol,” Dr. Meade said. “Also, weight loss may decrease the amount of medication needed to achieve glycemic control.”

According to Dr. Meade, it’s common for diabetic patients to ask about weight-loss drugs. “They have heard about them from friends or have seen advertisements on TV or the Internet or in magazines,” she said. However, “in general we do not encourage the use of medications for weight loss until the patient has demonstrated weight loss on their own. Counseling is very important so patients realize they will have more weight loss if combined with diet and exercise.”

Dr. Meade noted that the newer weight-loss medications – Qsymia (phentermine and topiramate), Belviq (lorcaserin HCl), Contrave (naltrexone HCl/bupropion HCl), and Saxenda (liraglutide) – are indicated in obese adults with a body mass index of 30 or above or those with a BMI of 27 with at least one comorbid condition, such as hypertension, type 2 diabetes, or dyslipidemia. Contrave is unusual: It’s a mix of the antidepressant bupropion (Wellbutrin) and the addiction drug naltrexone (Revia).

There are several other weight-loss drugs, including orlistat, which is available both by prescription (Xenical) and over-the-counter (Alli). Orlistat is famously linked to “anal leakage” – GI problems and oily and fatty stools.

Weight-loss drugs are controversial. Consumer Reports has warned against using Alli, Xenical, Belviq, Qsymia, and Saxenda “because they don’t help most people lose much, if any, weight, and they all carry potentially serious risks.” Earlier this year, Consumer Reports took aim at Contrave, too: “Nearly 1 in 4 people in the clinical trials stopped taking the prescription weight loss pill because they couldn’t tolerate the common side effects, including nausea, headache, and vomiting.”

As for other side effects, Dr. Meade noted that weight loss can cause hypoglycemia, so diabetes medications may need to be reduced. “Educators need to know that phentermine [in Qsymia and other weight-loss medications] is contraindicated for patients with any type of coronary artery disease [uncontrolled hypertension, stroke, arrhythmias or heart failure],” she said. There are concerns about cardiac issues in patients who take other weight-loss drugs, too.

Also, Belviq is not recommended in patients who are taking certain medications for depression, Dr. Meade said, “and some medications for depression and smoking cessation would be contraindicated with Contrave.”

Dr. Meade cautioned that the new drugs often aren’t covered by insurance and can be too expensive for patients. Goodrx.com estimates the cash price for a month’s supply of Contrave at $264-$295, although discounts and coupons can reduce that amount.

If patients do want to try the weight-loss drugs, Dr. Rochester urges educators to inform them about “the reality of the weight loss expected and remind patients that the research was completed in patients who also incorporated diet and exercise.”

Dr. Rochester and Dr. Meade report no relevant disclosures.

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Weight-loss medications have a role in the management of diabetes, as long as physicians and patients realize these drugs are not an easy fix.

In light of their side effects and other complications, weight-loss drugs haven’t reached their full diet-in-a-pill potential. Diet drugs remain controversial even as the Food and Drug Administration continues to approve new formulations. Such weight-loss medications can still play a role in the care of diabetic patient, according to a pair of diabetes educators.

 

The key, they say, is to understand the limits of their potential and their not-so-limited drawbacks. “There is no magic pill,” said Charmaine Rochester, PharmD, an associate professor of pharmacy with the University of Maryland School of Pharmacy, Baltimore. “Patients need to know that it is not an easy fix. They still have to change their lifestyles with the medications.”

Dr. Rochester and Lisa Meade, PharmD, CDE, an associate professor of pharmacy at Wingate (N.C.) University School of Pharmacy, spoke about weight loss medications and diabetes care at the annual meeting of the American Association of Diabetes Educators and in later interviews.

These medications produce weight loss in the 5%-10% range. Still, “weight loss as little as 5% can significantly improve glycemic control, and modest weight loss of 5% to under 10% has been associated with significant improvements in cardiovascular disease risk factors at 1 year – decreased inflammation, improvement in insulin resistance, improved blood pressure, and improved cholesterol,” Dr. Meade said. “Also, weight loss may decrease the amount of medication needed to achieve glycemic control.”

According to Dr. Meade, it’s common for diabetic patients to ask about weight-loss drugs. “They have heard about them from friends or have seen advertisements on TV or the Internet or in magazines,” she said. However, “in general we do not encourage the use of medications for weight loss until the patient has demonstrated weight loss on their own. Counseling is very important so patients realize they will have more weight loss if combined with diet and exercise.”

Dr. Meade noted that the newer weight-loss medications – Qsymia (phentermine and topiramate), Belviq (lorcaserin HCl), Contrave (naltrexone HCl/bupropion HCl), and Saxenda (liraglutide) – are indicated in obese adults with a body mass index of 30 or above or those with a BMI of 27 with at least one comorbid condition, such as hypertension, type 2 diabetes, or dyslipidemia. Contrave is unusual: It’s a mix of the antidepressant bupropion (Wellbutrin) and the addiction drug naltrexone (Revia).

There are several other weight-loss drugs, including orlistat, which is available both by prescription (Xenical) and over-the-counter (Alli). Orlistat is famously linked to “anal leakage” – GI problems and oily and fatty stools.

Weight-loss drugs are controversial. Consumer Reports has warned against using Alli, Xenical, Belviq, Qsymia, and Saxenda “because they don’t help most people lose much, if any, weight, and they all carry potentially serious risks.” Earlier this year, Consumer Reports took aim at Contrave, too: “Nearly 1 in 4 people in the clinical trials stopped taking the prescription weight loss pill because they couldn’t tolerate the common side effects, including nausea, headache, and vomiting.”

As for other side effects, Dr. Meade noted that weight loss can cause hypoglycemia, so diabetes medications may need to be reduced. “Educators need to know that phentermine [in Qsymia and other weight-loss medications] is contraindicated for patients with any type of coronary artery disease [uncontrolled hypertension, stroke, arrhythmias or heart failure],” she said. There are concerns about cardiac issues in patients who take other weight-loss drugs, too.

Also, Belviq is not recommended in patients who are taking certain medications for depression, Dr. Meade said, “and some medications for depression and smoking cessation would be contraindicated with Contrave.”

Dr. Meade cautioned that the new drugs often aren’t covered by insurance and can be too expensive for patients. Goodrx.com estimates the cash price for a month’s supply of Contrave at $264-$295, although discounts and coupons can reduce that amount.

If patients do want to try the weight-loss drugs, Dr. Rochester urges educators to inform them about “the reality of the weight loss expected and remind patients that the research was completed in patients who also incorporated diet and exercise.”

Dr. Rochester and Dr. Meade report no relevant disclosures.

 

Weight-loss medications have a role in the management of diabetes, as long as physicians and patients realize these drugs are not an easy fix.

In light of their side effects and other complications, weight-loss drugs haven’t reached their full diet-in-a-pill potential. Diet drugs remain controversial even as the Food and Drug Administration continues to approve new formulations. Such weight-loss medications can still play a role in the care of diabetic patient, according to a pair of diabetes educators.

 

The key, they say, is to understand the limits of their potential and their not-so-limited drawbacks. “There is no magic pill,” said Charmaine Rochester, PharmD, an associate professor of pharmacy with the University of Maryland School of Pharmacy, Baltimore. “Patients need to know that it is not an easy fix. They still have to change their lifestyles with the medications.”

Dr. Rochester and Lisa Meade, PharmD, CDE, an associate professor of pharmacy at Wingate (N.C.) University School of Pharmacy, spoke about weight loss medications and diabetes care at the annual meeting of the American Association of Diabetes Educators and in later interviews.

These medications produce weight loss in the 5%-10% range. Still, “weight loss as little as 5% can significantly improve glycemic control, and modest weight loss of 5% to under 10% has been associated with significant improvements in cardiovascular disease risk factors at 1 year – decreased inflammation, improvement in insulin resistance, improved blood pressure, and improved cholesterol,” Dr. Meade said. “Also, weight loss may decrease the amount of medication needed to achieve glycemic control.”

According to Dr. Meade, it’s common for diabetic patients to ask about weight-loss drugs. “They have heard about them from friends or have seen advertisements on TV or the Internet or in magazines,” she said. However, “in general we do not encourage the use of medications for weight loss until the patient has demonstrated weight loss on their own. Counseling is very important so patients realize they will have more weight loss if combined with diet and exercise.”

Dr. Meade noted that the newer weight-loss medications – Qsymia (phentermine and topiramate), Belviq (lorcaserin HCl), Contrave (naltrexone HCl/bupropion HCl), and Saxenda (liraglutide) – are indicated in obese adults with a body mass index of 30 or above or those with a BMI of 27 with at least one comorbid condition, such as hypertension, type 2 diabetes, or dyslipidemia. Contrave is unusual: It’s a mix of the antidepressant bupropion (Wellbutrin) and the addiction drug naltrexone (Revia).

There are several other weight-loss drugs, including orlistat, which is available both by prescription (Xenical) and over-the-counter (Alli). Orlistat is famously linked to “anal leakage” – GI problems and oily and fatty stools.

Weight-loss drugs are controversial. Consumer Reports has warned against using Alli, Xenical, Belviq, Qsymia, and Saxenda “because they don’t help most people lose much, if any, weight, and they all carry potentially serious risks.” Earlier this year, Consumer Reports took aim at Contrave, too: “Nearly 1 in 4 people in the clinical trials stopped taking the prescription weight loss pill because they couldn’t tolerate the common side effects, including nausea, headache, and vomiting.”

As for other side effects, Dr. Meade noted that weight loss can cause hypoglycemia, so diabetes medications may need to be reduced. “Educators need to know that phentermine [in Qsymia and other weight-loss medications] is contraindicated for patients with any type of coronary artery disease [uncontrolled hypertension, stroke, arrhythmias or heart failure],” she said. There are concerns about cardiac issues in patients who take other weight-loss drugs, too.

Also, Belviq is not recommended in patients who are taking certain medications for depression, Dr. Meade said, “and some medications for depression and smoking cessation would be contraindicated with Contrave.”

Dr. Meade cautioned that the new drugs often aren’t covered by insurance and can be too expensive for patients. Goodrx.com estimates the cash price for a month’s supply of Contrave at $264-$295, although discounts and coupons can reduce that amount.

If patients do want to try the weight-loss drugs, Dr. Rochester urges educators to inform them about “the reality of the weight loss expected and remind patients that the research was completed in patients who also incorporated diet and exercise.”

Dr. Rochester and Dr. Meade report no relevant disclosures.

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EXPERT ANALYSIS FROM AADE 16 

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Caution is key when prescribing spironolactone for adult acne

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NEWPORT BEACH, CALIF. – While off-label use of spironolactone for treatment of acne is quite common, it should be prescribed with special caution, advised Julie C. Harper, MD.

“The vast majority of you write this for acne,” Dr. Harper, a dermatologist in private practice in Birmingham, Ala., said during a presentation on adult acne at the Skin Disease Education Foundation’s Women’s & Pediatric Dermatology Seminar.

Dr. Julie C. Harper


She offered this blunt advice about one potential patient group: “Do not use this in men.” She cited a 2006 Japanese study of 139 patients with acne, treated with oral spironolactone, which found that 3 of the 23 males in the study developed gynecomastia within 4-6 weeks. Subsequently, the treatment was stopped in all male patients (Aesthetic Plast Surg. 2006 Nov-Dec;30[6]:689-94).

In the same study, 80% of the 116 females in the study experienced menstrual irregularities. “We have to tell our patients that’s a possible side effect, that they may get breast tenderness or menstrual irregularities,” Dr. Harper said. “If you don’t tell them, they’re not thinking of acne drugs as causing this.”

What about the risk of hyperkalemia in patients who take spironolactone, which is a diuretic? A retrospective study found similar hyperkalemia rates among healthy young women taking spironolactone for acne or an endocrine disorder with associated acne (mean age 26-27 years) and among healthy young women not taking spironolactone. The authors concluded that routine potassium testing was not necessary in healthy young women who take the drug (JAMA Dermatol. 2015 Sep;151[9]:941-4).

Dr. Harper recommended testing, however, if patients are older, have a history of renal or cardiac disease, have impaired hepatic function, or are taking higher doses of spironolactone.

She also cautioned that spironolactone should not be taken with lithium, and that it boosts the risk of digoxin toxicity.

Research doesn’t indicate that the risk of breast cancer is increased in women taking spironolactone, she said, nor does there appear to be a risk in lactating mothers. But the drug should not be taken during pregnancy or by women who could become pregnant, she noted.

Dr. Harper warned against the use of tetracyclines and erythromycin estolate when treating pregnant women with acne. She avoids using topical retinoids, although she said they are probably safe in small areas. Benzoyl peroxide is acceptable for small areas, as are topical azelaic acid and clindamycin, she added.

For information about acne treatment in lactating mothers, she cited a 2014 review (J Am Acad Dermatol. 2014 Mar;70[3]:417.e1-417.e10.). Erythromycin, azithromycin, and clarithromycin are considered appropriate for short-term use, she said, as are tetracyclines, but for less than 3 weeks only. Oral clindamycin is acceptable, but may cause gastrointestinal side effects in the nursing infant; topical use appears to be appropriate, she said.

Topical treatment with benzoyl peroxide is also appropriate for lactating women, she said, and topical retinoids are probably safe on small areas. Topical azelaic acid is considered a low risk to the nursing infant, she added.

Dr. Harper disclosed financial relationships of various types with Allergan, Bayer, BiopharmX, Galderma, Novan, Promius and Valeant.

SDEF and this news organization are owned by Frontline Medical Communications.
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NEWPORT BEACH, CALIF. – While off-label use of spironolactone for treatment of acne is quite common, it should be prescribed with special caution, advised Julie C. Harper, MD.

“The vast majority of you write this for acne,” Dr. Harper, a dermatologist in private practice in Birmingham, Ala., said during a presentation on adult acne at the Skin Disease Education Foundation’s Women’s & Pediatric Dermatology Seminar.

Dr. Julie C. Harper


She offered this blunt advice about one potential patient group: “Do not use this in men.” She cited a 2006 Japanese study of 139 patients with acne, treated with oral spironolactone, which found that 3 of the 23 males in the study developed gynecomastia within 4-6 weeks. Subsequently, the treatment was stopped in all male patients (Aesthetic Plast Surg. 2006 Nov-Dec;30[6]:689-94).

In the same study, 80% of the 116 females in the study experienced menstrual irregularities. “We have to tell our patients that’s a possible side effect, that they may get breast tenderness or menstrual irregularities,” Dr. Harper said. “If you don’t tell them, they’re not thinking of acne drugs as causing this.”

What about the risk of hyperkalemia in patients who take spironolactone, which is a diuretic? A retrospective study found similar hyperkalemia rates among healthy young women taking spironolactone for acne or an endocrine disorder with associated acne (mean age 26-27 years) and among healthy young women not taking spironolactone. The authors concluded that routine potassium testing was not necessary in healthy young women who take the drug (JAMA Dermatol. 2015 Sep;151[9]:941-4).

Dr. Harper recommended testing, however, if patients are older, have a history of renal or cardiac disease, have impaired hepatic function, or are taking higher doses of spironolactone.

She also cautioned that spironolactone should not be taken with lithium, and that it boosts the risk of digoxin toxicity.

Research doesn’t indicate that the risk of breast cancer is increased in women taking spironolactone, she said, nor does there appear to be a risk in lactating mothers. But the drug should not be taken during pregnancy or by women who could become pregnant, she noted.

Dr. Harper warned against the use of tetracyclines and erythromycin estolate when treating pregnant women with acne. She avoids using topical retinoids, although she said they are probably safe in small areas. Benzoyl peroxide is acceptable for small areas, as are topical azelaic acid and clindamycin, she added.

For information about acne treatment in lactating mothers, she cited a 2014 review (J Am Acad Dermatol. 2014 Mar;70[3]:417.e1-417.e10.). Erythromycin, azithromycin, and clarithromycin are considered appropriate for short-term use, she said, as are tetracyclines, but for less than 3 weeks only. Oral clindamycin is acceptable, but may cause gastrointestinal side effects in the nursing infant; topical use appears to be appropriate, she said.

Topical treatment with benzoyl peroxide is also appropriate for lactating women, she said, and topical retinoids are probably safe on small areas. Topical azelaic acid is considered a low risk to the nursing infant, she added.

Dr. Harper disclosed financial relationships of various types with Allergan, Bayer, BiopharmX, Galderma, Novan, Promius and Valeant.

SDEF and this news organization are owned by Frontline Medical Communications.

 

NEWPORT BEACH, CALIF. – While off-label use of spironolactone for treatment of acne is quite common, it should be prescribed with special caution, advised Julie C. Harper, MD.

“The vast majority of you write this for acne,” Dr. Harper, a dermatologist in private practice in Birmingham, Ala., said during a presentation on adult acne at the Skin Disease Education Foundation’s Women’s & Pediatric Dermatology Seminar.

Dr. Julie C. Harper


She offered this blunt advice about one potential patient group: “Do not use this in men.” She cited a 2006 Japanese study of 139 patients with acne, treated with oral spironolactone, which found that 3 of the 23 males in the study developed gynecomastia within 4-6 weeks. Subsequently, the treatment was stopped in all male patients (Aesthetic Plast Surg. 2006 Nov-Dec;30[6]:689-94).

In the same study, 80% of the 116 females in the study experienced menstrual irregularities. “We have to tell our patients that’s a possible side effect, that they may get breast tenderness or menstrual irregularities,” Dr. Harper said. “If you don’t tell them, they’re not thinking of acne drugs as causing this.”

What about the risk of hyperkalemia in patients who take spironolactone, which is a diuretic? A retrospective study found similar hyperkalemia rates among healthy young women taking spironolactone for acne or an endocrine disorder with associated acne (mean age 26-27 years) and among healthy young women not taking spironolactone. The authors concluded that routine potassium testing was not necessary in healthy young women who take the drug (JAMA Dermatol. 2015 Sep;151[9]:941-4).

Dr. Harper recommended testing, however, if patients are older, have a history of renal or cardiac disease, have impaired hepatic function, or are taking higher doses of spironolactone.

She also cautioned that spironolactone should not be taken with lithium, and that it boosts the risk of digoxin toxicity.

Research doesn’t indicate that the risk of breast cancer is increased in women taking spironolactone, she said, nor does there appear to be a risk in lactating mothers. But the drug should not be taken during pregnancy or by women who could become pregnant, she noted.

Dr. Harper warned against the use of tetracyclines and erythromycin estolate when treating pregnant women with acne. She avoids using topical retinoids, although she said they are probably safe in small areas. Benzoyl peroxide is acceptable for small areas, as are topical azelaic acid and clindamycin, she added.

For information about acne treatment in lactating mothers, she cited a 2014 review (J Am Acad Dermatol. 2014 Mar;70[3]:417.e1-417.e10.). Erythromycin, azithromycin, and clarithromycin are considered appropriate for short-term use, she said, as are tetracyclines, but for less than 3 weeks only. Oral clindamycin is acceptable, but may cause gastrointestinal side effects in the nursing infant; topical use appears to be appropriate, she said.

Topical treatment with benzoyl peroxide is also appropriate for lactating women, she said, and topical retinoids are probably safe on small areas. Topical azelaic acid is considered a low risk to the nursing infant, she added.

Dr. Harper disclosed financial relationships of various types with Allergan, Bayer, BiopharmX, Galderma, Novan, Promius and Valeant.

SDEF and this news organization are owned by Frontline Medical Communications.
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AT SDEF WOMEN’S & PEDIATRIC DERMATOLOGY SEMINAR

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Give guidance, not just Viagra, to men with diabetes and related impotence

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Diabetic men with erectile dysfunction might consider a prescription for a drug like Viagra to be a permanent cure for a temporary issue: Take a pill, problem solved. But the truth, a leading urologist says, is entirely different.

“If a diabetic patient has erectile dysfunction, it’s not enough to provide Viagra [sildenafil] or Cialis [tadalafil] and then send him on his merry way,” J. Francois Eid, MD, a New York City urologist, said at the annual meeting of the American Association of Diabetes Educators. “It’s important to let individuals know the drug has not cured the erectile dysfunction. If patients don’t take care of the diabetes, the erectile dysfunction progresses.”

 

In an interview, Dr. Eid shared several messages for medical professionals who treat men with diabetes and related erectile dysfunction:

• Diabetes has “devastating” effects on the penis, and may even cause it to shrink.

• Long-term uncontrolled diabetes can make ED permanent.

• While ED drugs often fail in men with diabetes, several other options exist; and penis implants may provide significant relief.

How big is the problem? An estimated 50%-75% of men with diabetes experience from some degree of ED, which is thought to be three times more common in diabetic men than other men, according to Dr. Eid.

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Diabetic men with erectile dysfunction might consider a prescription for a drug like Viagra to be a permanent cure for a temporary issue: Take a pill, problem solved. But the truth, a leading urologist says, is entirely different.

“If a diabetic patient has erectile dysfunction, it’s not enough to provide Viagra [sildenafil] or Cialis [tadalafil] and then send him on his merry way,” J. Francois Eid, MD, a New York City urologist, said at the annual meeting of the American Association of Diabetes Educators. “It’s important to let individuals know the drug has not cured the erectile dysfunction. If patients don’t take care of the diabetes, the erectile dysfunction progresses.”

 

In an interview, Dr. Eid shared several messages for medical professionals who treat men with diabetes and related erectile dysfunction:

• Diabetes has “devastating” effects on the penis, and may even cause it to shrink.

• Long-term uncontrolled diabetes can make ED permanent.

• While ED drugs often fail in men with diabetes, several other options exist; and penis implants may provide significant relief.

How big is the problem? An estimated 50%-75% of men with diabetes experience from some degree of ED, which is thought to be three times more common in diabetic men than other men, according to Dr. Eid.

 

Diabetic men with erectile dysfunction might consider a prescription for a drug like Viagra to be a permanent cure for a temporary issue: Take a pill, problem solved. But the truth, a leading urologist says, is entirely different.

“If a diabetic patient has erectile dysfunction, it’s not enough to provide Viagra [sildenafil] or Cialis [tadalafil] and then send him on his merry way,” J. Francois Eid, MD, a New York City urologist, said at the annual meeting of the American Association of Diabetes Educators. “It’s important to let individuals know the drug has not cured the erectile dysfunction. If patients don’t take care of the diabetes, the erectile dysfunction progresses.”

 

In an interview, Dr. Eid shared several messages for medical professionals who treat men with diabetes and related erectile dysfunction:

• Diabetes has “devastating” effects on the penis, and may even cause it to shrink.

• Long-term uncontrolled diabetes can make ED permanent.

• While ED drugs often fail in men with diabetes, several other options exist; and penis implants may provide significant relief.

How big is the problem? An estimated 50%-75% of men with diabetes experience from some degree of ED, which is thought to be three times more common in diabetic men than other men, according to Dr. Eid.

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EXPERT ANALYSIS FROM AADE 16

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Close monitoring of psoriasis patients can delay PsA onset

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NEWPORT BEACH, CALIF. – A patient with psoriasis can develop crippling psoriatic arthritis (PsA) within 5 to 10 years of diagnosis, but monitoring patients for signs of trouble can help prevent the onset of PsA, according to Alan Menter, MD.

Even a simple foot examination can make a huge difference, noted Dr. Menter, chief of the division of dermatology and director of the Psoriasis Research Institute at Baylor University Medical Center, Dallas. “At every visit, you and I should be looking for early signs of joint disease,” he said at the Skin Disease Education Foundation’s Women’s & Pediatric Dermatology Seminar. “We should not let these patients develop any joint disease because we have drugs that can prevent joint destruction.”

Dr. Alan Menter
Estimates regarding the proportion of psoriasis patients who have PsA vary widely. The International Federation of Psoriasis Associations estimates that 30%-50% of people with psoriasis have PsA, while the Centers for Disease Control and Prevention estimates that 10%-20% of psoriasis patients eventually develop PsA. A study published in 2005 cited estimates ranging from 6% to 42% (Ann Rheum Dis. 2005;64:ii14-ii17).

Dr. Menter pointed out that PsA is a disease that is distinct from psoriasis. “It’s linked to psoriasis, but genetically, there are differences,” he said, “and immunologically, what goes on in skin is not identical.”

He provided the following pearls regarding diagnosing PsA:

• Be on the lookout for “sausage fingers” and “sausage toes,” both signs of PsA. “You and I are very visual people, and we can see a swollen toe or finger very easily,” Dr. Menter said. “I take the shoes off every psoriasis patient at every visit and run my thumb and index finger down the Achilles. I look for a swollen Achilles – classic enthesitis.” In some cases, swollen big toes in psoriasis patients may be misdiagnosed as gout instead of PsA, he noted.

• Ask patients about how their joints feel when they wake up in the morning: Do they have swelling and tenderness? “That’s an early marker of psoriatic arthritis disease,” Dr. Menter said. In contrast, in a patient with osteoarthritis, “the more they use their joints, the worse it gets.”

• The severity of psoriasis has nothing to do with the severity of PsA. “You can have 50% of the body covered with psoriasis but no arthritis,” he said. “Or you can have someone with one patch of psoriasis on the scalp with devastating joint disease.”

• Be aware that there are five PsA subtypes that can occur in combination with each other:

1. Dactylitis. This is the form that causes the “sausage digit.”

2. Asymmetric oligoarthritis. This is the type most commonly seen on presentation, when there are few joints affected.

3. Symmetric arthritis. This form is more common in females and difficult to differentiate from rheumatoid arthritis.

4. Distal interphalangeal joint arthritis. This type is often linked to dactylitis and nail dystrophy.

5. Arthritis mutilans. This is more common in females, linked to long disease duration, and present in an estimated 5% of cases.
 

Dr. Menter suggested that dermatologists refer suspected cases of PsA to a rheumatologist. Since patients may have to wait 6-10 weeks for an appointment, he recommended that dermatologists consider NSAIDs, such as the over-the-counter naproxen and prescription meloxicam and celecoxib in the meantime. Dermatologists may also consider bringing up the use of methotrexate and biologics, he said.

Dr. Menter disclosed relationships with multiple pharmaceutical companies, including AbbVie, Allergan, Amgen, Boehringer Ingelheim, Eli Lilly, Merck, Novartis, and Pfizer.

SDEF and this news organization are owned by Frontline Medical Communications.

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NEWPORT BEACH, CALIF. – A patient with psoriasis can develop crippling psoriatic arthritis (PsA) within 5 to 10 years of diagnosis, but monitoring patients for signs of trouble can help prevent the onset of PsA, according to Alan Menter, MD.

Even a simple foot examination can make a huge difference, noted Dr. Menter, chief of the division of dermatology and director of the Psoriasis Research Institute at Baylor University Medical Center, Dallas. “At every visit, you and I should be looking for early signs of joint disease,” he said at the Skin Disease Education Foundation’s Women’s & Pediatric Dermatology Seminar. “We should not let these patients develop any joint disease because we have drugs that can prevent joint destruction.”

Dr. Alan Menter
Estimates regarding the proportion of psoriasis patients who have PsA vary widely. The International Federation of Psoriasis Associations estimates that 30%-50% of people with psoriasis have PsA, while the Centers for Disease Control and Prevention estimates that 10%-20% of psoriasis patients eventually develop PsA. A study published in 2005 cited estimates ranging from 6% to 42% (Ann Rheum Dis. 2005;64:ii14-ii17).

Dr. Menter pointed out that PsA is a disease that is distinct from psoriasis. “It’s linked to psoriasis, but genetically, there are differences,” he said, “and immunologically, what goes on in skin is not identical.”

He provided the following pearls regarding diagnosing PsA:

• Be on the lookout for “sausage fingers” and “sausage toes,” both signs of PsA. “You and I are very visual people, and we can see a swollen toe or finger very easily,” Dr. Menter said. “I take the shoes off every psoriasis patient at every visit and run my thumb and index finger down the Achilles. I look for a swollen Achilles – classic enthesitis.” In some cases, swollen big toes in psoriasis patients may be misdiagnosed as gout instead of PsA, he noted.

• Ask patients about how their joints feel when they wake up in the morning: Do they have swelling and tenderness? “That’s an early marker of psoriatic arthritis disease,” Dr. Menter said. In contrast, in a patient with osteoarthritis, “the more they use their joints, the worse it gets.”

• The severity of psoriasis has nothing to do with the severity of PsA. “You can have 50% of the body covered with psoriasis but no arthritis,” he said. “Or you can have someone with one patch of psoriasis on the scalp with devastating joint disease.”

• Be aware that there are five PsA subtypes that can occur in combination with each other:

1. Dactylitis. This is the form that causes the “sausage digit.”

2. Asymmetric oligoarthritis. This is the type most commonly seen on presentation, when there are few joints affected.

3. Symmetric arthritis. This form is more common in females and difficult to differentiate from rheumatoid arthritis.

4. Distal interphalangeal joint arthritis. This type is often linked to dactylitis and nail dystrophy.

5. Arthritis mutilans. This is more common in females, linked to long disease duration, and present in an estimated 5% of cases.
 

Dr. Menter suggested that dermatologists refer suspected cases of PsA to a rheumatologist. Since patients may have to wait 6-10 weeks for an appointment, he recommended that dermatologists consider NSAIDs, such as the over-the-counter naproxen and prescription meloxicam and celecoxib in the meantime. Dermatologists may also consider bringing up the use of methotrexate and biologics, he said.

Dr. Menter disclosed relationships with multiple pharmaceutical companies, including AbbVie, Allergan, Amgen, Boehringer Ingelheim, Eli Lilly, Merck, Novartis, and Pfizer.

SDEF and this news organization are owned by Frontline Medical Communications.

NEWPORT BEACH, CALIF. – A patient with psoriasis can develop crippling psoriatic arthritis (PsA) within 5 to 10 years of diagnosis, but monitoring patients for signs of trouble can help prevent the onset of PsA, according to Alan Menter, MD.

Even a simple foot examination can make a huge difference, noted Dr. Menter, chief of the division of dermatology and director of the Psoriasis Research Institute at Baylor University Medical Center, Dallas. “At every visit, you and I should be looking for early signs of joint disease,” he said at the Skin Disease Education Foundation’s Women’s & Pediatric Dermatology Seminar. “We should not let these patients develop any joint disease because we have drugs that can prevent joint destruction.”

Dr. Alan Menter
Estimates regarding the proportion of psoriasis patients who have PsA vary widely. The International Federation of Psoriasis Associations estimates that 30%-50% of people with psoriasis have PsA, while the Centers for Disease Control and Prevention estimates that 10%-20% of psoriasis patients eventually develop PsA. A study published in 2005 cited estimates ranging from 6% to 42% (Ann Rheum Dis. 2005;64:ii14-ii17).

Dr. Menter pointed out that PsA is a disease that is distinct from psoriasis. “It’s linked to psoriasis, but genetically, there are differences,” he said, “and immunologically, what goes on in skin is not identical.”

He provided the following pearls regarding diagnosing PsA:

• Be on the lookout for “sausage fingers” and “sausage toes,” both signs of PsA. “You and I are very visual people, and we can see a swollen toe or finger very easily,” Dr. Menter said. “I take the shoes off every psoriasis patient at every visit and run my thumb and index finger down the Achilles. I look for a swollen Achilles – classic enthesitis.” In some cases, swollen big toes in psoriasis patients may be misdiagnosed as gout instead of PsA, he noted.

• Ask patients about how their joints feel when they wake up in the morning: Do they have swelling and tenderness? “That’s an early marker of psoriatic arthritis disease,” Dr. Menter said. In contrast, in a patient with osteoarthritis, “the more they use their joints, the worse it gets.”

• The severity of psoriasis has nothing to do with the severity of PsA. “You can have 50% of the body covered with psoriasis but no arthritis,” he said. “Or you can have someone with one patch of psoriasis on the scalp with devastating joint disease.”

• Be aware that there are five PsA subtypes that can occur in combination with each other:

1. Dactylitis. This is the form that causes the “sausage digit.”

2. Asymmetric oligoarthritis. This is the type most commonly seen on presentation, when there are few joints affected.

3. Symmetric arthritis. This form is more common in females and difficult to differentiate from rheumatoid arthritis.

4. Distal interphalangeal joint arthritis. This type is often linked to dactylitis and nail dystrophy.

5. Arthritis mutilans. This is more common in females, linked to long disease duration, and present in an estimated 5% of cases.
 

Dr. Menter suggested that dermatologists refer suspected cases of PsA to a rheumatologist. Since patients may have to wait 6-10 weeks for an appointment, he recommended that dermatologists consider NSAIDs, such as the over-the-counter naproxen and prescription meloxicam and celecoxib in the meantime. Dermatologists may also consider bringing up the use of methotrexate and biologics, he said.

Dr. Menter disclosed relationships with multiple pharmaceutical companies, including AbbVie, Allergan, Amgen, Boehringer Ingelheim, Eli Lilly, Merck, Novartis, and Pfizer.

SDEF and this news organization are owned by Frontline Medical Communications.

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EXPERT ANALYSIS FROM SDEF WOMEN'S & PEDIATRIC DERMATOLOGY SEMINAR 
 

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Study provides best support to date for using ultrasound to detect gout

Solid evidence for usefulness with clinical suspicion of gout
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Ultrasound examination of patients with at least one swollen joint or a subcutaneous nodule detected gout with a sensitivity of 76.9% and specificity of 84.3% in an international, multicenter study.

“Ultrasound is a good test for gout,” said study lead author Alexis R. Ogdie-Beatty, MD, of the University of Pennsylvania, Philadelphia. “It has high specificity, even among patients with early disease. The sensitivity was lower so it doesn’t pick up all cases of gout, although it was higher in people with a longer duration of disease.”

Dr. Alexis R. Ogdie-Beatty
Gout has a large impact on patients and the health care system in the United States. A 2013 study attributed an estimated 7 million annual ambulatory visits to gout during 2002-2008. The study estimated the cost of ambulatory care at $933 million a year, and it noted that the rate of visits per year had doubled over the time period of the study (Am J Pharm Benefits. 2013;5[2]:e46-54).

But gout remains difficult to diagnose because of the many similar types of inflammatory arthritis. A 2016 report from the Agency for Healthcare Research and Quality says proper diagnosis is a “major challenge,” especially in primary care and urgent/emergency settings.

Monosodium urate (MSU) crystal analysis via joint aspiration is considered the “gold standard” of gout diagnostic tools, but the agency report notes that it “can be technically difficult to perform and painful to the patient.”

There are other challenges. “Sometimes we see people between flares, or it’s already started to improve so there’s not enough fluid to perform an arthrocentesis,” Dr. Ogdie-Beatty said in an interview. “Additionally, while rheumatologists are generally very good at joint aspirations, many primary care physicians are not specifically trained for this. Thus, an imaging study can be helpful in these cases.”

The new study (Arthritis Rheumatol. 2016 Oct 16. doi: 10.1002/art.39959) follows up on findings from the multicenter, cross-sectional Study for Updated Gout Classification Criteria, which independently linked ultrasound analysis to diagnosis of gout with an odds ratio of 7.2 (Arthritis Care Res. 2015 Sep;67[9]:1304-15). One goal of the new study is to determine specificity and sensitivity of ultrasound exams.

The researchers examined data from the previous study, which enrolled consecutive patients in clinical practice settings across 25 countries who had at least one swollen joint or a subcutaneous nodule in whom gout was on the differential diagnosis. They underwent ultrasound examinations (most commonly of the knees, metatarsophalangeal joints, and ankles) and were deemed to have a “positive test” if at least one of three signs appeared: a “double contour” sign, tophus, or a “snowstorm” appearance. However, the study did not require a specific ultrasound scanning protocol or training.

MSU crystal examinations confirmed which of the subjects actually had gout. In total, ultrasound examinations were performed on 824 patients, of whom 416 were confirmed to have gout (mean age, 60, and 87% male), and the other 408 did not have gout (mean age, 60, and 54% male).

The researchers found that the sensitivity of the ultrasound exams was 76.9%, meaning they correctly identified patients with gout just over three-quarters of the time. Dr. Ogdie-Beatty referred to this as “moderate” sensitivity. The researchers found that the sensitivity was highest in patients who’d had disease for 2 or more years and in those who didn’t show clinical signs of tophi.

The specificity for these signs – the percentage of the time that ultrasound exams correctly identified patients without gout – was 84.3%. The positive and negative predictive values were 83.3% and 78.1%, respectively.

Dr. Ogdie-Beatty said the cost of ultrasound examinations is variable, although insurance covers it for trained providers. It’s unclear how commonly ultrasound examinations are used to detect gout, she said, but “many rheumatologists now have ultrasound as a part of their practice, and ultrasound training during fellowship has become important.”

Dr. Ogdie-Beatty reported receiving consulting fees from Novartis, and her coauthors reported various financial relationships with industry. The study was supported by various National Institutes of Health grants to several authors, as well as the American College of Rheumatology, the European League Against Rheumatism, and various arthritis-related organizations.
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The new study provides evidence that both answers and raises questions about the technical standards by which musculoskeletal ultrasound examination is used to detect gout and about what we mean when we make a clinical diagnosis of gout.

The study’s results showed that ultrasound provided excellent specificity for gout in the setting of acute calcium pyrophosphate deposition disease (CPPD), also known as pseudogout, particularly in distinguishing the deposition of monosodium urate on the surface of cartilage (double contour sign), and calcium pyrophosphate within the matrix of the cartilage (interface sign). Ultrasound’s specificity for gout apart from CPPD was particularly high when more than one feature of gout was present because one feature of gout was more often present in patients with CPPD than in non-CPPD controls, but this was not the case when two features of gout were present. However, this leaves open the possibility that some patients may concurrently have both CPPD and gout, which the study does not fully address. Apart from the level of operator experience in using ultrasound, diagnostic bias did not seem to play a role in the diagnostic utility of ultrasound because clinical appearance of scanned joints or presence of tophi did not greatly affect its sensitivity when considering that patients with tophi have more advanced disease and probably have more obvious ultrasound findings.

The study’s demonstration of ultrasound’s ability to identify tophi is important because rheumatologists consider the presence of tophi as marking the transition from hyperuricemia to gout, which often involves of inflammation and tissue damage. Many other studies have noted how people with hyperuricemia can have the double contour sign without meeting clinical criteria for gout.

It still remains important to note that, even though the test characteristics of ultrasound in the study should be generalizable, its ability to support a diagnosis of acute gout does not rule out infection in the same joint.
 

Eugene Y. Kissin, MD, is with the division of rheumatology at Boston University, and Michael H. Pillinger, MD, is with the division of rheumatology at New York University, New York. Their comments are derived from their editorial accompanying the study by Dr. Ogdie-Beatty and her colleagues (Arthritis Rheumatol. 2016 Oct 16. doi: 10.1002/art.39958). Dr. Kissin reported no disclosures. Dr. Pillinger reported consulting for AstraZeneca, Crealta/Horizon, and Sobi, and he has served as an investigator for a trial sponsored by Takeda.

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The new study provides evidence that both answers and raises questions about the technical standards by which musculoskeletal ultrasound examination is used to detect gout and about what we mean when we make a clinical diagnosis of gout.

The study’s results showed that ultrasound provided excellent specificity for gout in the setting of acute calcium pyrophosphate deposition disease (CPPD), also known as pseudogout, particularly in distinguishing the deposition of monosodium urate on the surface of cartilage (double contour sign), and calcium pyrophosphate within the matrix of the cartilage (interface sign). Ultrasound’s specificity for gout apart from CPPD was particularly high when more than one feature of gout was present because one feature of gout was more often present in patients with CPPD than in non-CPPD controls, but this was not the case when two features of gout were present. However, this leaves open the possibility that some patients may concurrently have both CPPD and gout, which the study does not fully address. Apart from the level of operator experience in using ultrasound, diagnostic bias did not seem to play a role in the diagnostic utility of ultrasound because clinical appearance of scanned joints or presence of tophi did not greatly affect its sensitivity when considering that patients with tophi have more advanced disease and probably have more obvious ultrasound findings.

The study’s demonstration of ultrasound’s ability to identify tophi is important because rheumatologists consider the presence of tophi as marking the transition from hyperuricemia to gout, which often involves of inflammation and tissue damage. Many other studies have noted how people with hyperuricemia can have the double contour sign without meeting clinical criteria for gout.

It still remains important to note that, even though the test characteristics of ultrasound in the study should be generalizable, its ability to support a diagnosis of acute gout does not rule out infection in the same joint.
 

Eugene Y. Kissin, MD, is with the division of rheumatology at Boston University, and Michael H. Pillinger, MD, is with the division of rheumatology at New York University, New York. Their comments are derived from their editorial accompanying the study by Dr. Ogdie-Beatty and her colleagues (Arthritis Rheumatol. 2016 Oct 16. doi: 10.1002/art.39958). Dr. Kissin reported no disclosures. Dr. Pillinger reported consulting for AstraZeneca, Crealta/Horizon, and Sobi, and he has served as an investigator for a trial sponsored by Takeda.

Body

 

The new study provides evidence that both answers and raises questions about the technical standards by which musculoskeletal ultrasound examination is used to detect gout and about what we mean when we make a clinical diagnosis of gout.

The study’s results showed that ultrasound provided excellent specificity for gout in the setting of acute calcium pyrophosphate deposition disease (CPPD), also known as pseudogout, particularly in distinguishing the deposition of monosodium urate on the surface of cartilage (double contour sign), and calcium pyrophosphate within the matrix of the cartilage (interface sign). Ultrasound’s specificity for gout apart from CPPD was particularly high when more than one feature of gout was present because one feature of gout was more often present in patients with CPPD than in non-CPPD controls, but this was not the case when two features of gout were present. However, this leaves open the possibility that some patients may concurrently have both CPPD and gout, which the study does not fully address. Apart from the level of operator experience in using ultrasound, diagnostic bias did not seem to play a role in the diagnostic utility of ultrasound because clinical appearance of scanned joints or presence of tophi did not greatly affect its sensitivity when considering that patients with tophi have more advanced disease and probably have more obvious ultrasound findings.

The study’s demonstration of ultrasound’s ability to identify tophi is important because rheumatologists consider the presence of tophi as marking the transition from hyperuricemia to gout, which often involves of inflammation and tissue damage. Many other studies have noted how people with hyperuricemia can have the double contour sign without meeting clinical criteria for gout.

It still remains important to note that, even though the test characteristics of ultrasound in the study should be generalizable, its ability to support a diagnosis of acute gout does not rule out infection in the same joint.
 

Eugene Y. Kissin, MD, is with the division of rheumatology at Boston University, and Michael H. Pillinger, MD, is with the division of rheumatology at New York University, New York. Their comments are derived from their editorial accompanying the study by Dr. Ogdie-Beatty and her colleagues (Arthritis Rheumatol. 2016 Oct 16. doi: 10.1002/art.39958). Dr. Kissin reported no disclosures. Dr. Pillinger reported consulting for AstraZeneca, Crealta/Horizon, and Sobi, and he has served as an investigator for a trial sponsored by Takeda.

Title
Solid evidence for usefulness with clinical suspicion of gout
Solid evidence for usefulness with clinical suspicion of gout

 

Ultrasound examination of patients with at least one swollen joint or a subcutaneous nodule detected gout with a sensitivity of 76.9% and specificity of 84.3% in an international, multicenter study.

“Ultrasound is a good test for gout,” said study lead author Alexis R. Ogdie-Beatty, MD, of the University of Pennsylvania, Philadelphia. “It has high specificity, even among patients with early disease. The sensitivity was lower so it doesn’t pick up all cases of gout, although it was higher in people with a longer duration of disease.”

Dr. Alexis R. Ogdie-Beatty
Gout has a large impact on patients and the health care system in the United States. A 2013 study attributed an estimated 7 million annual ambulatory visits to gout during 2002-2008. The study estimated the cost of ambulatory care at $933 million a year, and it noted that the rate of visits per year had doubled over the time period of the study (Am J Pharm Benefits. 2013;5[2]:e46-54).

But gout remains difficult to diagnose because of the many similar types of inflammatory arthritis. A 2016 report from the Agency for Healthcare Research and Quality says proper diagnosis is a “major challenge,” especially in primary care and urgent/emergency settings.

Monosodium urate (MSU) crystal analysis via joint aspiration is considered the “gold standard” of gout diagnostic tools, but the agency report notes that it “can be technically difficult to perform and painful to the patient.”

There are other challenges. “Sometimes we see people between flares, or it’s already started to improve so there’s not enough fluid to perform an arthrocentesis,” Dr. Ogdie-Beatty said in an interview. “Additionally, while rheumatologists are generally very good at joint aspirations, many primary care physicians are not specifically trained for this. Thus, an imaging study can be helpful in these cases.”

The new study (Arthritis Rheumatol. 2016 Oct 16. doi: 10.1002/art.39959) follows up on findings from the multicenter, cross-sectional Study for Updated Gout Classification Criteria, which independently linked ultrasound analysis to diagnosis of gout with an odds ratio of 7.2 (Arthritis Care Res. 2015 Sep;67[9]:1304-15). One goal of the new study is to determine specificity and sensitivity of ultrasound exams.

The researchers examined data from the previous study, which enrolled consecutive patients in clinical practice settings across 25 countries who had at least one swollen joint or a subcutaneous nodule in whom gout was on the differential diagnosis. They underwent ultrasound examinations (most commonly of the knees, metatarsophalangeal joints, and ankles) and were deemed to have a “positive test” if at least one of three signs appeared: a “double contour” sign, tophus, or a “snowstorm” appearance. However, the study did not require a specific ultrasound scanning protocol or training.

MSU crystal examinations confirmed which of the subjects actually had gout. In total, ultrasound examinations were performed on 824 patients, of whom 416 were confirmed to have gout (mean age, 60, and 87% male), and the other 408 did not have gout (mean age, 60, and 54% male).

The researchers found that the sensitivity of the ultrasound exams was 76.9%, meaning they correctly identified patients with gout just over three-quarters of the time. Dr. Ogdie-Beatty referred to this as “moderate” sensitivity. The researchers found that the sensitivity was highest in patients who’d had disease for 2 or more years and in those who didn’t show clinical signs of tophi.

The specificity for these signs – the percentage of the time that ultrasound exams correctly identified patients without gout – was 84.3%. The positive and negative predictive values were 83.3% and 78.1%, respectively.

Dr. Ogdie-Beatty said the cost of ultrasound examinations is variable, although insurance covers it for trained providers. It’s unclear how commonly ultrasound examinations are used to detect gout, she said, but “many rheumatologists now have ultrasound as a part of their practice, and ultrasound training during fellowship has become important.”

Dr. Ogdie-Beatty reported receiving consulting fees from Novartis, and her coauthors reported various financial relationships with industry. The study was supported by various National Institutes of Health grants to several authors, as well as the American College of Rheumatology, the European League Against Rheumatism, and various arthritis-related organizations.

 

Ultrasound examination of patients with at least one swollen joint or a subcutaneous nodule detected gout with a sensitivity of 76.9% and specificity of 84.3% in an international, multicenter study.

“Ultrasound is a good test for gout,” said study lead author Alexis R. Ogdie-Beatty, MD, of the University of Pennsylvania, Philadelphia. “It has high specificity, even among patients with early disease. The sensitivity was lower so it doesn’t pick up all cases of gout, although it was higher in people with a longer duration of disease.”

Dr. Alexis R. Ogdie-Beatty
Gout has a large impact on patients and the health care system in the United States. A 2013 study attributed an estimated 7 million annual ambulatory visits to gout during 2002-2008. The study estimated the cost of ambulatory care at $933 million a year, and it noted that the rate of visits per year had doubled over the time period of the study (Am J Pharm Benefits. 2013;5[2]:e46-54).

But gout remains difficult to diagnose because of the many similar types of inflammatory arthritis. A 2016 report from the Agency for Healthcare Research and Quality says proper diagnosis is a “major challenge,” especially in primary care and urgent/emergency settings.

Monosodium urate (MSU) crystal analysis via joint aspiration is considered the “gold standard” of gout diagnostic tools, but the agency report notes that it “can be technically difficult to perform and painful to the patient.”

There are other challenges. “Sometimes we see people between flares, or it’s already started to improve so there’s not enough fluid to perform an arthrocentesis,” Dr. Ogdie-Beatty said in an interview. “Additionally, while rheumatologists are generally very good at joint aspirations, many primary care physicians are not specifically trained for this. Thus, an imaging study can be helpful in these cases.”

The new study (Arthritis Rheumatol. 2016 Oct 16. doi: 10.1002/art.39959) follows up on findings from the multicenter, cross-sectional Study for Updated Gout Classification Criteria, which independently linked ultrasound analysis to diagnosis of gout with an odds ratio of 7.2 (Arthritis Care Res. 2015 Sep;67[9]:1304-15). One goal of the new study is to determine specificity and sensitivity of ultrasound exams.

The researchers examined data from the previous study, which enrolled consecutive patients in clinical practice settings across 25 countries who had at least one swollen joint or a subcutaneous nodule in whom gout was on the differential diagnosis. They underwent ultrasound examinations (most commonly of the knees, metatarsophalangeal joints, and ankles) and were deemed to have a “positive test” if at least one of three signs appeared: a “double contour” sign, tophus, or a “snowstorm” appearance. However, the study did not require a specific ultrasound scanning protocol or training.

MSU crystal examinations confirmed which of the subjects actually had gout. In total, ultrasound examinations were performed on 824 patients, of whom 416 were confirmed to have gout (mean age, 60, and 87% male), and the other 408 did not have gout (mean age, 60, and 54% male).

The researchers found that the sensitivity of the ultrasound exams was 76.9%, meaning they correctly identified patients with gout just over three-quarters of the time. Dr. Ogdie-Beatty referred to this as “moderate” sensitivity. The researchers found that the sensitivity was highest in patients who’d had disease for 2 or more years and in those who didn’t show clinical signs of tophi.

The specificity for these signs – the percentage of the time that ultrasound exams correctly identified patients without gout – was 84.3%. The positive and negative predictive values were 83.3% and 78.1%, respectively.

Dr. Ogdie-Beatty said the cost of ultrasound examinations is variable, although insurance covers it for trained providers. It’s unclear how commonly ultrasound examinations are used to detect gout, she said, but “many rheumatologists now have ultrasound as a part of their practice, and ultrasound training during fellowship has become important.”

Dr. Ogdie-Beatty reported receiving consulting fees from Novartis, and her coauthors reported various financial relationships with industry. The study was supported by various National Institutes of Health grants to several authors, as well as the American College of Rheumatology, the European League Against Rheumatism, and various arthritis-related organizations.
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Key clinical point: When gout is clinically suspected, ultrasound is slightly better at confirming that patients don’t have gout than at detecting it in patients who do.

Major finding: Examiners looked for at least one of three potential signs of gout. The sensitivity for gout was 76.9%, and the specificity was 84.3%.

Data source: 824 patients with potential signs of gout who underwent ultrasound examination in an international, multicenter, observational cross-sectional study

Disclosures: Dr. Ogdie-Beatty reported receiving consulting fees from Novartis, and her coauthors reported various financial relationships with industry. The study was supported by various National Institutes of Health grants to several authors, as well as the American College of Rheumatology, the European League Against Rheumatism, and various arthritis-related organizations.

UC patients who failed infliximab gain from vedolizumab

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Vedolizumab (Entyvio) was much more effective than placebo as a treatment for ulcerative colitis (UC) in a range of patients, researchers found in a follow-up analysis of trial data.

©selvanegra/thinkstockphotos.com
At issue is how do different groups of UC patients benefit from vedolizumab, which was approved by the Food and Drug Administration in 2014 as a treatment for adult patients with moderate to severe ulcerative colitis or Crohn’s disease?

According to background information in the study, tumor necrosis factor–alpha (TNF) antagonist therapy has significantly improved treatment for ulcerative colitis, but many patients fail to respond. There is also a risk of infection.

The new study, published online Sept. 14 in Clinical Gastroenterology and Hepatology (2016. doi: 10.1016/j.cgh.2016.08.044), offers prespecified exploratory and post hoc analyses of vedolizumab vs. placebo in sets of UC patients from a phase III trial.

In a blinded group, 374 patients were randomly assigned to receive intravenous vedolizumab or placebo on days 1 and 15; 521 other patients in an open-label group received intravenous vedolizumab in the same fashion.

Patients in both groups who responded to vedolizumab at 6 weeks were randomly assigned to one of three groups: They continued vedolizumab every 8 weeks or every 4 weeks, or they received a placebo at week 6 for as many as 46 weeks. Patients who initially received the placebo either continued taking it over the maintenance period or stopped; those who didn’t respond to vedolizumab continued to get it every 4 weeks through week 52.

The new study focuses on 464 patients had not taken a TNF antagonist previously and 367 who’d failed TNF-antagonist therapy.

At week 6, 53.1% of the vedolizumab patients who hadn’t tried a TNF antagonist saw a clinical response, compared with 26.3% of counterparts who took a placebo (absolute difference, 26.4%; 95% confidence interval, 12.4-40.4; relative risk, 2.0; 95% CI, 1.3-3.0).

Among patients who had failed TNF antagonists, 39.0% saw a clinical response on vedolizumab at 6 weeks, and 20.6% saw one on placebo (absolute difference, 18.1%; 95% CI, 2.8-33.5; RR, 1.9; 95% CI, 1.1-3.2.). All those who’d failed TNF antagonists had taken infliximab because it was the only drug of its type available at the time of enrollment.

At week 52, the percentage of TNF antagonist–naive patients who were in remission was 46.9% in those on vedolizumab and 19.0% in those on placebo (absolute difference: 28.0%; 95% CI, 14.9-41.1; RR, 2.5; 95% CI, 1.5-4.0.) Among those who’d failed TNF-antagonist therapy, 36.1% of those on vedolizumab reached remission, and just 5.3% of those on placebo did (absolute difference, 29.5%; 95% CI, 12.8-46.1; RR, 6.6; 95% CI, 1.7-26.5.)

“These analyses show that vedolizumab had a consistent benefit for inducing and maintaining clinical response and remission in both TNF-naive and TNF-failure patients with moderately to severely active UC,” the authors write. “Further, no increased rates of serious infections were observed with vedolizumab treatment relative to placebo in either subgroup.”

The study authors caution against comparing the efficacy statistics in this study to the results of trials of TNF antagonists. While it’s “alluring” to make the comparison, they write, “We would caution against using such an approach to determine relative efficacy, given the confounding effects of differences in patient populations, outcome definitions, and, notably, trial design.”

They note that a study comparing the safety and efficacy of vedolizumab to adalimumab (Humira) in ulcerative colitis is underway (NCT02497469) – it’s now recruiting patients – and “the results of such studies will be critical in informing payers regarding the relative value of these agents.”

What’s next? The researchers note that TNF-antagonist alternatives to infliximab now exist. “Randomized trials should be performed comparing vedolizumab to the use of a second TNF antagonist in TNF -antagonist failure patients with adequate serum drug concentrations,” they write.

Millennium Pharmaceuticals (Takeda Pharmaceuticals) funded the clinical studies. Some of the study authors are employees of Takeda. Other study authors have received support from Takeda, Millennium, or both.

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Vedolizumab (Entyvio) was much more effective than placebo as a treatment for ulcerative colitis (UC) in a range of patients, researchers found in a follow-up analysis of trial data.

©selvanegra/thinkstockphotos.com
At issue is how do different groups of UC patients benefit from vedolizumab, which was approved by the Food and Drug Administration in 2014 as a treatment for adult patients with moderate to severe ulcerative colitis or Crohn’s disease?

According to background information in the study, tumor necrosis factor–alpha (TNF) antagonist therapy has significantly improved treatment for ulcerative colitis, but many patients fail to respond. There is also a risk of infection.

The new study, published online Sept. 14 in Clinical Gastroenterology and Hepatology (2016. doi: 10.1016/j.cgh.2016.08.044), offers prespecified exploratory and post hoc analyses of vedolizumab vs. placebo in sets of UC patients from a phase III trial.

In a blinded group, 374 patients were randomly assigned to receive intravenous vedolizumab or placebo on days 1 and 15; 521 other patients in an open-label group received intravenous vedolizumab in the same fashion.

Patients in both groups who responded to vedolizumab at 6 weeks were randomly assigned to one of three groups: They continued vedolizumab every 8 weeks or every 4 weeks, or they received a placebo at week 6 for as many as 46 weeks. Patients who initially received the placebo either continued taking it over the maintenance period or stopped; those who didn’t respond to vedolizumab continued to get it every 4 weeks through week 52.

The new study focuses on 464 patients had not taken a TNF antagonist previously and 367 who’d failed TNF-antagonist therapy.

At week 6, 53.1% of the vedolizumab patients who hadn’t tried a TNF antagonist saw a clinical response, compared with 26.3% of counterparts who took a placebo (absolute difference, 26.4%; 95% confidence interval, 12.4-40.4; relative risk, 2.0; 95% CI, 1.3-3.0).

Among patients who had failed TNF antagonists, 39.0% saw a clinical response on vedolizumab at 6 weeks, and 20.6% saw one on placebo (absolute difference, 18.1%; 95% CI, 2.8-33.5; RR, 1.9; 95% CI, 1.1-3.2.). All those who’d failed TNF antagonists had taken infliximab because it was the only drug of its type available at the time of enrollment.

At week 52, the percentage of TNF antagonist–naive patients who were in remission was 46.9% in those on vedolizumab and 19.0% in those on placebo (absolute difference: 28.0%; 95% CI, 14.9-41.1; RR, 2.5; 95% CI, 1.5-4.0.) Among those who’d failed TNF-antagonist therapy, 36.1% of those on vedolizumab reached remission, and just 5.3% of those on placebo did (absolute difference, 29.5%; 95% CI, 12.8-46.1; RR, 6.6; 95% CI, 1.7-26.5.)

“These analyses show that vedolizumab had a consistent benefit for inducing and maintaining clinical response and remission in both TNF-naive and TNF-failure patients with moderately to severely active UC,” the authors write. “Further, no increased rates of serious infections were observed with vedolizumab treatment relative to placebo in either subgroup.”

The study authors caution against comparing the efficacy statistics in this study to the results of trials of TNF antagonists. While it’s “alluring” to make the comparison, they write, “We would caution against using such an approach to determine relative efficacy, given the confounding effects of differences in patient populations, outcome definitions, and, notably, trial design.”

They note that a study comparing the safety and efficacy of vedolizumab to adalimumab (Humira) in ulcerative colitis is underway (NCT02497469) – it’s now recruiting patients – and “the results of such studies will be critical in informing payers regarding the relative value of these agents.”

What’s next? The researchers note that TNF-antagonist alternatives to infliximab now exist. “Randomized trials should be performed comparing vedolizumab to the use of a second TNF antagonist in TNF -antagonist failure patients with adequate serum drug concentrations,” they write.

Millennium Pharmaceuticals (Takeda Pharmaceuticals) funded the clinical studies. Some of the study authors are employees of Takeda. Other study authors have received support from Takeda, Millennium, or both.


Vedolizumab (Entyvio) was much more effective than placebo as a treatment for ulcerative colitis (UC) in a range of patients, researchers found in a follow-up analysis of trial data.

©selvanegra/thinkstockphotos.com
At issue is how do different groups of UC patients benefit from vedolizumab, which was approved by the Food and Drug Administration in 2014 as a treatment for adult patients with moderate to severe ulcerative colitis or Crohn’s disease?

According to background information in the study, tumor necrosis factor–alpha (TNF) antagonist therapy has significantly improved treatment for ulcerative colitis, but many patients fail to respond. There is also a risk of infection.

The new study, published online Sept. 14 in Clinical Gastroenterology and Hepatology (2016. doi: 10.1016/j.cgh.2016.08.044), offers prespecified exploratory and post hoc analyses of vedolizumab vs. placebo in sets of UC patients from a phase III trial.

In a blinded group, 374 patients were randomly assigned to receive intravenous vedolizumab or placebo on days 1 and 15; 521 other patients in an open-label group received intravenous vedolizumab in the same fashion.

Patients in both groups who responded to vedolizumab at 6 weeks were randomly assigned to one of three groups: They continued vedolizumab every 8 weeks or every 4 weeks, or they received a placebo at week 6 for as many as 46 weeks. Patients who initially received the placebo either continued taking it over the maintenance period or stopped; those who didn’t respond to vedolizumab continued to get it every 4 weeks through week 52.

The new study focuses on 464 patients had not taken a TNF antagonist previously and 367 who’d failed TNF-antagonist therapy.

At week 6, 53.1% of the vedolizumab patients who hadn’t tried a TNF antagonist saw a clinical response, compared with 26.3% of counterparts who took a placebo (absolute difference, 26.4%; 95% confidence interval, 12.4-40.4; relative risk, 2.0; 95% CI, 1.3-3.0).

Among patients who had failed TNF antagonists, 39.0% saw a clinical response on vedolizumab at 6 weeks, and 20.6% saw one on placebo (absolute difference, 18.1%; 95% CI, 2.8-33.5; RR, 1.9; 95% CI, 1.1-3.2.). All those who’d failed TNF antagonists had taken infliximab because it was the only drug of its type available at the time of enrollment.

At week 52, the percentage of TNF antagonist–naive patients who were in remission was 46.9% in those on vedolizumab and 19.0% in those on placebo (absolute difference: 28.0%; 95% CI, 14.9-41.1; RR, 2.5; 95% CI, 1.5-4.0.) Among those who’d failed TNF-antagonist therapy, 36.1% of those on vedolizumab reached remission, and just 5.3% of those on placebo did (absolute difference, 29.5%; 95% CI, 12.8-46.1; RR, 6.6; 95% CI, 1.7-26.5.)

“These analyses show that vedolizumab had a consistent benefit for inducing and maintaining clinical response and remission in both TNF-naive and TNF-failure patients with moderately to severely active UC,” the authors write. “Further, no increased rates of serious infections were observed with vedolizumab treatment relative to placebo in either subgroup.”

The study authors caution against comparing the efficacy statistics in this study to the results of trials of TNF antagonists. While it’s “alluring” to make the comparison, they write, “We would caution against using such an approach to determine relative efficacy, given the confounding effects of differences in patient populations, outcome definitions, and, notably, trial design.”

They note that a study comparing the safety and efficacy of vedolizumab to adalimumab (Humira) in ulcerative colitis is underway (NCT02497469) – it’s now recruiting patients – and “the results of such studies will be critical in informing payers regarding the relative value of these agents.”

What’s next? The researchers note that TNF-antagonist alternatives to infliximab now exist. “Randomized trials should be performed comparing vedolizumab to the use of a second TNF antagonist in TNF -antagonist failure patients with adequate serum drug concentrations,” they write.

Millennium Pharmaceuticals (Takeda Pharmaceuticals) funded the clinical studies. Some of the study authors are employees of Takeda. Other study authors have received support from Takeda, Millennium, or both.

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Key clinical point: Vedolizumab provided benefits to ulcerative colitis patients who failed infliximab, but they didn’t fare as well as those who never tried TNF-antagonist therapy.

Major finding: Of UC patients who took vedolizumab for 52 weeks, 46.9% of those who’d never tried TNF-antagonist therapy were in remission, compared with 36.1% of those who failed infliximab.

Data source: Post hoc analysis of 831 patients with moderate to severe UC in a multicenter, randomized, phase III trial of vedolizumab vs. placebo.

Disclosures: Millennium Pharmaceuticals (Takeda Pharmaceuticals) funded the clinical studies. Some of the study authors are employees of Takeda. Other study authors have received support from Takeda, Millennium, or both.

Pharmacists urge more focus on kidney disease indicator

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– Assessing the risk of kidney disease in diabetes requires estimating the glomerular filtration rate.

“One of the big campaigns is Know Your Numbers, and we think of ABC,” also known as hemoglobin A1c, blood pressure, and cholesterol levels, noted Andrew Bzowyckyj, PharmD, BCPS, CDE. “Now we have eGFR, which measures kidney function. It’s something quantifiable that patients can follow.”

Dr. Anderew Bzowycky
Earlier this year, the Food and Drug Administration encouraged wider use of metformin in certain patients with kidney disease based on estimated glomerular filtration rate (eGFR) levels. But some providers haven’t fully embraced the importance of eGFR in evaluating the appropriateness of metformin, Dr. Bzowyckyj says. “We’ve all been so entranced by looking at serum creatinine since 1994,” when metformin was introduced in the United States, he says. “There’s 20 years of history you have to undo.”

Dr. Bzowyckyj of the University of Missouri-Kansas City School of Pharmacy, and Ashley Crowl, PharmD, BCACP, of the School of Pharmacy at the University of Kansas, spoke about the importance of eGFR at the annual meeting of the American Association of Diabetes Educators.

At issue has been the high rate of chronic kidney disease in diabetics. According to the Centers for Disease Control and Prevention, in 2011, about 50,000 people in the United States began treatment for kidney failure caused by diabetes. And almost 230,000 people were on dialysis or had gotten kidney transplants necessitated by kidney failure that year.

“Educators need to realize their role is not only to manage diabetes but also prevent and educate about concurrent kidney disease,” according to Dr. Bzowyckyj. “We want to empower educators to know they can make a difference.”

It’s important to understand that the serum creatinine level (SCr) itself shouldn’t be used alone to determine kidney function, the pharmacists noted. These tests provide some insight into kidney function by measuring the level of the waste product creatinine; higher levels are a sign that the kidneys aren’t removing waste properly.

But the levels can be misleading. “Some health care professionals see an elevated SCr and quickly label a patient with chronic kidney disease. But other factors need to be considered before providing this diagnosis. You cannot look at one SCr level, which can be increased or decreased by many factors.”

For example, “if you’re a body builder, you’ll have a high creatinine, but your kidneys could be just fine,” Dr. Bzowyckyj said. Dehydration, rhabdomyolysis, and medical problems related to pregnancy can also boost levels, while lower muscle mass and malnutrition can lower them.

Dr. Ashley Crowl
Instead of basing the diagnosis on the SCr level alone, the two pharmacists recommended looking at the eGFR, a number that’s derived from a calculation that may include serum creatinine, weight, race, gender, and height. “It gives you a more clear picture of what’s happening,” Dr. Crowl said.

According to the National Kidney Foundation, eGFR in most healthy people is 90 mL/min per 1.73 m2 or above. An eGFR of less than 90 mL/min per 1.73 m2 for 3 months or more is a sign of kidney disease.

The two pharmacists said that it’s important for diabetes educators to monitor eGFR because it helps them get a better idea about whether they should urge a physician to adjust the medications taken by their patients. With the help of eGFR, “we can get more people more appropriately on metformin,” Dr. Crowl says.

The FDA is on board. In April, the agency announced labeling changes for metformin drugs “to expand metformin’s use in certain patients with reduced kidney function” and recommended that measurements such as eGFR be used instead of SCr to determine whether a patient with kidney disease should take metformin.

The FDA now believes that “metformin can be used safely in patients with mild impairment in kidney function and in some patients with moderate impairment in kidney function.” It is not recommended for those with severe cases, the agency has said.

Dr. Bzowyckyj and Dr. Crowl reported having no relevant financial disclosures.
 
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– Assessing the risk of kidney disease in diabetes requires estimating the glomerular filtration rate.

“One of the big campaigns is Know Your Numbers, and we think of ABC,” also known as hemoglobin A1c, blood pressure, and cholesterol levels, noted Andrew Bzowyckyj, PharmD, BCPS, CDE. “Now we have eGFR, which measures kidney function. It’s something quantifiable that patients can follow.”

Dr. Anderew Bzowycky
Earlier this year, the Food and Drug Administration encouraged wider use of metformin in certain patients with kidney disease based on estimated glomerular filtration rate (eGFR) levels. But some providers haven’t fully embraced the importance of eGFR in evaluating the appropriateness of metformin, Dr. Bzowyckyj says. “We’ve all been so entranced by looking at serum creatinine since 1994,” when metformin was introduced in the United States, he says. “There’s 20 years of history you have to undo.”

Dr. Bzowyckyj of the University of Missouri-Kansas City School of Pharmacy, and Ashley Crowl, PharmD, BCACP, of the School of Pharmacy at the University of Kansas, spoke about the importance of eGFR at the annual meeting of the American Association of Diabetes Educators.

At issue has been the high rate of chronic kidney disease in diabetics. According to the Centers for Disease Control and Prevention, in 2011, about 50,000 people in the United States began treatment for kidney failure caused by diabetes. And almost 230,000 people were on dialysis or had gotten kidney transplants necessitated by kidney failure that year.

“Educators need to realize their role is not only to manage diabetes but also prevent and educate about concurrent kidney disease,” according to Dr. Bzowyckyj. “We want to empower educators to know they can make a difference.”

It’s important to understand that the serum creatinine level (SCr) itself shouldn’t be used alone to determine kidney function, the pharmacists noted. These tests provide some insight into kidney function by measuring the level of the waste product creatinine; higher levels are a sign that the kidneys aren’t removing waste properly.

But the levels can be misleading. “Some health care professionals see an elevated SCr and quickly label a patient with chronic kidney disease. But other factors need to be considered before providing this diagnosis. You cannot look at one SCr level, which can be increased or decreased by many factors.”

For example, “if you’re a body builder, you’ll have a high creatinine, but your kidneys could be just fine,” Dr. Bzowyckyj said. Dehydration, rhabdomyolysis, and medical problems related to pregnancy can also boost levels, while lower muscle mass and malnutrition can lower them.

Dr. Ashley Crowl
Instead of basing the diagnosis on the SCr level alone, the two pharmacists recommended looking at the eGFR, a number that’s derived from a calculation that may include serum creatinine, weight, race, gender, and height. “It gives you a more clear picture of what’s happening,” Dr. Crowl said.

According to the National Kidney Foundation, eGFR in most healthy people is 90 mL/min per 1.73 m2 or above. An eGFR of less than 90 mL/min per 1.73 m2 for 3 months or more is a sign of kidney disease.

The two pharmacists said that it’s important for diabetes educators to monitor eGFR because it helps them get a better idea about whether they should urge a physician to adjust the medications taken by their patients. With the help of eGFR, “we can get more people more appropriately on metformin,” Dr. Crowl says.

The FDA is on board. In April, the agency announced labeling changes for metformin drugs “to expand metformin’s use in certain patients with reduced kidney function” and recommended that measurements such as eGFR be used instead of SCr to determine whether a patient with kidney disease should take metformin.

The FDA now believes that “metformin can be used safely in patients with mild impairment in kidney function and in some patients with moderate impairment in kidney function.” It is not recommended for those with severe cases, the agency has said.

Dr. Bzowyckyj and Dr. Crowl reported having no relevant financial disclosures.
 

 

– Assessing the risk of kidney disease in diabetes requires estimating the glomerular filtration rate.

“One of the big campaigns is Know Your Numbers, and we think of ABC,” also known as hemoglobin A1c, blood pressure, and cholesterol levels, noted Andrew Bzowyckyj, PharmD, BCPS, CDE. “Now we have eGFR, which measures kidney function. It’s something quantifiable that patients can follow.”

Dr. Anderew Bzowycky
Earlier this year, the Food and Drug Administration encouraged wider use of metformin in certain patients with kidney disease based on estimated glomerular filtration rate (eGFR) levels. But some providers haven’t fully embraced the importance of eGFR in evaluating the appropriateness of metformin, Dr. Bzowyckyj says. “We’ve all been so entranced by looking at serum creatinine since 1994,” when metformin was introduced in the United States, he says. “There’s 20 years of history you have to undo.”

Dr. Bzowyckyj of the University of Missouri-Kansas City School of Pharmacy, and Ashley Crowl, PharmD, BCACP, of the School of Pharmacy at the University of Kansas, spoke about the importance of eGFR at the annual meeting of the American Association of Diabetes Educators.

At issue has been the high rate of chronic kidney disease in diabetics. According to the Centers for Disease Control and Prevention, in 2011, about 50,000 people in the United States began treatment for kidney failure caused by diabetes. And almost 230,000 people were on dialysis or had gotten kidney transplants necessitated by kidney failure that year.

“Educators need to realize their role is not only to manage diabetes but also prevent and educate about concurrent kidney disease,” according to Dr. Bzowyckyj. “We want to empower educators to know they can make a difference.”

It’s important to understand that the serum creatinine level (SCr) itself shouldn’t be used alone to determine kidney function, the pharmacists noted. These tests provide some insight into kidney function by measuring the level of the waste product creatinine; higher levels are a sign that the kidneys aren’t removing waste properly.

But the levels can be misleading. “Some health care professionals see an elevated SCr and quickly label a patient with chronic kidney disease. But other factors need to be considered before providing this diagnosis. You cannot look at one SCr level, which can be increased or decreased by many factors.”

For example, “if you’re a body builder, you’ll have a high creatinine, but your kidneys could be just fine,” Dr. Bzowyckyj said. Dehydration, rhabdomyolysis, and medical problems related to pregnancy can also boost levels, while lower muscle mass and malnutrition can lower them.

Dr. Ashley Crowl
Instead of basing the diagnosis on the SCr level alone, the two pharmacists recommended looking at the eGFR, a number that’s derived from a calculation that may include serum creatinine, weight, race, gender, and height. “It gives you a more clear picture of what’s happening,” Dr. Crowl said.

According to the National Kidney Foundation, eGFR in most healthy people is 90 mL/min per 1.73 m2 or above. An eGFR of less than 90 mL/min per 1.73 m2 for 3 months or more is a sign of kidney disease.

The two pharmacists said that it’s important for diabetes educators to monitor eGFR because it helps them get a better idea about whether they should urge a physician to adjust the medications taken by their patients. With the help of eGFR, “we can get more people more appropriately on metformin,” Dr. Crowl says.

The FDA is on board. In April, the agency announced labeling changes for metformin drugs “to expand metformin’s use in certain patients with reduced kidney function” and recommended that measurements such as eGFR be used instead of SCr to determine whether a patient with kidney disease should take metformin.

The FDA now believes that “metformin can be used safely in patients with mild impairment in kidney function and in some patients with moderate impairment in kidney function.” It is not recommended for those with severe cases, the agency has said.

Dr. Bzowyckyj and Dr. Crowl reported having no relevant financial disclosures.
 
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