SDEF Hawaii Dermatology Seminar 2014

WAIKOLOA, HAWAII – The 2014 update of the American Academy of Dermatology guidelines on atopic dermatitis take a strong stance in favor of the use of topical calcineurin inhibitors as topical corticosteroid-sparing agents, even in children less than 2 years old, where the use of the medications remains off-label.

The evidence-based AAD guidelines bestow a Class A, Level of Evidence I recommendation for the use of topical calcineurin inhibitors as topical steroid-sparing agents. The proactive use of topical calcineurin inhibitors as proactively scheduled, short-term, intermittent maintenance therapy to prevent disease flares also gets an A-I recommendation in the guidelines. The report states that there is no need to monitor blood levels of topical calcineurin inhibitors, Dr. Wynnis Tom noted at the Hawaii Dermatology Seminar, sponsored by the Global Academy for Medical Education/Skin Disease Education Foundation.

The guidelines emphasize the importance of having a proactive discussion with the patient and/or parents about the black box warning for topical calcineurin inhibitors, stressing the fact that interim analyses of long-term surveillance studies do not show an increase in malignancies, said Dr. Tom, a member of the working group that developed the AAD guidelines and a pediatric dermatologist at the University of California, San Diego.

The section of the guidelines devoted to topical therapies includes a detailed description of wet wrap therapy, which is useful for quickly reducing atopic dermatitis severity during flares. The use of topical antihistamines gets a strong thumbs-down in the guidelines.

The guidelines go into considerable detail about the importance of fixing the skin barrier. Bathing is recommended as an important component of therapy, with the caveat that there is no good evidence as to the optimal frequency or duration.

"You want to get the crusting off and hydrate the skin; but you do have to be careful of how long the bath lasts, because you don’t want the skin to dry out as the water evaporates," Dr. Tom said. "I find bathing even daily is good, so long as people are using moisturizers afterward. That’s the key part both for treatment and maintenance: liberal use of moisturizers."

The guideline panel determined that while moisturizers are a cornerstone of atopic dermatitis therapy, no one moisturizer product has been shown to be better than the others. And that includes the prescription devices containing ceramides or hydrolipids, which haven’t persuasively been shown to have clinical advantages over inexpensive over-the-counter moisturizers.

The 2014 atopic dermatitis guidelines are the first-ever AAD guidelines to include an entire section devoted to the diagnosis of a dermatologic disorder (J. Am. Acad. Dermatol. 2014;70:338-51). This was deemed necessary because misdiagnosis of atopic dermatitis is a problem, particularly in adults.

The guidelines stress that atopic dermatitis is a clinical diagnosis that requires ruling out conditions including contact dermatitis, cutaneous T-cell lymphoma, psoriasis, photosensitivity reactions, seborrheic dermatitis, and immune deficiency diseases. At this time, no specific biomarkers can be recommended for the diagnosis of atopic dermatitis or assessment of its severity. In particular, according to the guidelines, the popular practice of monitoring immunoglobulin E levels isn’t recommended.

The comprehensive guidelines also include a section on phototherapy and systemic agents. In addition, a section on preventing disease flares and the use of adjunctive therapies is slated for release in June.

Dr. Tom reported serving as a financially uncompensated investigator for studies sponsored by Amgen and Anacor. SDEF and this news organization are owned by the same parent company.

bjancin@frontlinemedcom.com

WAIKOLOA, HAWAII – The 2014 update of the American Academy of Dermatology guidelines on atopic dermatitis take a strong stance in favor of the use of topical calcineurin inhibitors as topical corticosteroid-sparing agents, even in children less than 2 years old, where the use of the medications remains off-label.

The evidence-based AAD guidelines bestow a Class A, Level of Evidence I recommendation for the use of topical calcineurin inhibitors as topical steroid-sparing agents. The proactive use of topical calcineurin inhibitors as proactively scheduled, short-term, intermittent maintenance therapy to prevent disease flares also gets an A-I recommendation in the guidelines. The report states that there is no need to monitor blood levels of topical calcineurin inhibitors, Dr. Wynnis Tom noted at the Hawaii Dermatology Seminar, sponsored by the Global Academy for Medical Education/Skin Disease Education Foundation.

The guidelines emphasize the importance of having a proactive discussion with the patient and/or parents about the black box warning for topical calcineurin inhibitors, stressing the fact that interim analyses of long-term surveillance studies do not show an increase in malignancies, said Dr. Tom, a member of the working group that developed the AAD guidelines and a pediatric dermatologist at the University of California, San Diego.

The section of the guidelines devoted to topical therapies includes a detailed description of wet wrap therapy, which is useful for quickly reducing atopic dermatitis severity during flares. The use of topical antihistamines gets a strong thumbs-down in the guidelines.

The guidelines go into considerable detail about the importance of fixing the skin barrier. Bathing is recommended as an important component of therapy, with the caveat that there is no good evidence as to the optimal frequency or duration.

"You want to get the crusting off and hydrate the skin; but you do have to be careful of how long the bath lasts, because you don’t want the skin to dry out as the water evaporates," Dr. Tom said. "I find bathing even daily is good, so long as people are using moisturizers afterward. That’s the key part both for treatment and maintenance: liberal use of moisturizers."

The guideline panel determined that while moisturizers are a cornerstone of atopic dermatitis therapy, no one moisturizer product has been shown to be better than the others. And that includes the prescription devices containing ceramides or hydrolipids, which haven’t persuasively been shown to have clinical advantages over inexpensive over-the-counter moisturizers.

The 2014 atopic dermatitis guidelines are the first-ever AAD guidelines to include an entire section devoted to the diagnosis of a dermatologic disorder (J. Am. Acad. Dermatol. 2014;70:338-51). This was deemed necessary because misdiagnosis of atopic dermatitis is a problem, particularly in adults.

The guidelines stress that atopic dermatitis is a clinical diagnosis that requires ruling out conditions including contact dermatitis, cutaneous T-cell lymphoma, psoriasis, photosensitivity reactions, seborrheic dermatitis, and immune deficiency diseases. At this time, no specific biomarkers can be recommended for the diagnosis of atopic dermatitis or assessment of its severity. In particular, according to the guidelines, the popular practice of monitoring immunoglobulin E levels isn’t recommended.

The comprehensive guidelines also include a section on phototherapy and systemic agents. In addition, a section on preventing disease flares and the use of adjunctive therapies is slated for release in June.

Dr. Tom reported serving as a financially uncompensated investigator for studies sponsored by Amgen and Anacor. SDEF and this news organization are owned by the same parent company.

bjancin@frontlinemedcom.com

WAIKOLOA, HAWAII – The 2014 update of the American Academy of Dermatology guidelines on atopic dermatitis take a strong stance in favor of the use of topical calcineurin inhibitors as topical corticosteroid-sparing agents, even in children less than 2 years old, where the use of the medications remains off-label.

The evidence-based AAD guidelines bestow a Class A, Level of Evidence I recommendation for the use of topical calcineurin inhibitors as topical steroid-sparing agents. The proactive use of topical calcineurin inhibitors as proactively scheduled, short-term, intermittent maintenance therapy to prevent disease flares also gets an A-I recommendation in the guidelines. The report states that there is no need to monitor blood levels of topical calcineurin inhibitors, Dr. Wynnis Tom noted at the Hawaii Dermatology Seminar, sponsored by the Global Academy for Medical Education/Skin Disease Education Foundation.

The guidelines emphasize the importance of having a proactive discussion with the patient and/or parents about the black box warning for topical calcineurin inhibitors, stressing the fact that interim analyses of long-term surveillance studies do not show an increase in malignancies, said Dr. Tom, a member of the working group that developed the AAD guidelines and a pediatric dermatologist at the University of California, San Diego.

The section of the guidelines devoted to topical therapies includes a detailed description of wet wrap therapy, which is useful for quickly reducing atopic dermatitis severity during flares. The use of topical antihistamines gets a strong thumbs-down in the guidelines.

The guidelines go into considerable detail about the importance of fixing the skin barrier. Bathing is recommended as an important component of therapy, with the caveat that there is no good evidence as to the optimal frequency or duration.

"You want to get the crusting off and hydrate the skin; but you do have to be careful of how long the bath lasts, because you don’t want the skin to dry out as the water evaporates," Dr. Tom said. "I find bathing even daily is good, so long as people are using moisturizers afterward. That’s the key part both for treatment and maintenance: liberal use of moisturizers."

The guideline panel determined that while moisturizers are a cornerstone of atopic dermatitis therapy, no one moisturizer product has been shown to be better than the others. And that includes the prescription devices containing ceramides or hydrolipids, which haven’t persuasively been shown to have clinical advantages over inexpensive over-the-counter moisturizers.

The 2014 atopic dermatitis guidelines are the first-ever AAD guidelines to include an entire section devoted to the diagnosis of a dermatologic disorder (J. Am. Acad. Dermatol. 2014;70:338-51). This was deemed necessary because misdiagnosis of atopic dermatitis is a problem, particularly in adults.

The guidelines stress that atopic dermatitis is a clinical diagnosis that requires ruling out conditions including contact dermatitis, cutaneous T-cell lymphoma, psoriasis, photosensitivity reactions, seborrheic dermatitis, and immune deficiency diseases. At this time, no specific biomarkers can be recommended for the diagnosis of atopic dermatitis or assessment of its severity. In particular, according to the guidelines, the popular practice of monitoring immunoglobulin E levels isn’t recommended.

The comprehensive guidelines also include a section on phototherapy and systemic agents. In addition, a section on preventing disease flares and the use of adjunctive therapies is slated for release in June.

Dr. Tom reported serving as a financially uncompensated investigator for studies sponsored by Amgen and Anacor. SDEF and this news organization are owned by the same parent company.

bjancin@frontlinemedcom.com

WAIKOLOA, HAWAII – Fresh approaches for treating atopic dermatitis are sorely needed, and several intriguing novel therapies are under study, according to Dr. Wynnis Tom.

While topical corticosteroids continue to be the mainstay for control of the inflammation in atopic dermatitis, many patients and families have serious reservations about these medications. Patient concerns persist although, as emphasized in the updated 2014 American Academy of Dermatology guidelines for the management of atopic dermatitis (J. Am. Acad. Dermatol. 2014;70:338-51), these drugs have an excellent risk/benefit ratio when used appropriately.

It’s because of this widespread "steroid phobia" that AN2728 2% ointment is of particular interest, said Dr. Tom, a pediatric dermatologist at Rady Children’s Hospital and the University of California, San Diego.

AN2728 is a boron-based topical phosphodiesterase-4 inhibitor. The boron, she explained, provides added anti-inflammatory effects.

A recent phase I/II open-label, multicenter study involved 34 patients aged 2-17 years with mild to moderate atopic dermatitis and a 25%-35% body surface area of involvement. In this study, twice-daily application of AN2728 for 28 days resulted in 47% of participants achieving "clear" or "almost clear" on investigators’ global assessment, with at least a two-grade improvement from baseline. The affected body surface area plummeted by an average of 78%, while erythema, excoriations, and other symptoms also improved. Only one patient stopped therapy early.

A phase III trial is now in place. The big question relevant to clinical practice is, how does this agent compare in safety and efficacy to topical steroids and topical calcineurin inhibitors?

"We don’t know yet, but it’s nice to see there may be another class of anti-inflammatory agents we may be able to use, especially for those who are worried about topical steroids," Dr. Tom said at the SDEF Hawaii Dermatology Seminar sponsored by the Global Academy for Medical Education/Skin Disease Education Foundation.

For the minority of cases of atopic dermatitis that are more severe – and refractory to topical therapies – new agents in clinical trials include the oral phosphodiesterase-4 inhibitor apremilast and dupilumab, a monoclonal antibody that binds to the alpha subunit of the interleukin-4 receptor. Dupilumab, the first biologic agent to undergo evaluation for atopic dermatitis in a formal clinical trial, is now in a phase IIb trial involving adults with moderate to severe disease. Dupilumab is also under study for the treatment of other atopic diseases, including asthma.

Apremilast has been investigated in an open-label, prospective pilot study conducted by dermatologists at Oregon Health and Science University, Portland. The study included 16 adults with moderate to severe atopic dermatitis treated with oral apremilast at 20 or 30 mg b.i.d. for up to 6 months. Participants showed significant improvement on the Eczema Area and Severity Index, the Dermatology Life Quality Index, and other measures (Arch. Dermatol. 2012;148:890-7). Apremilast is approved as Otezla for the treatment of adults with psoriatic arthritis and is under study for other chronic inflammatory diseases, including rheumatoid arthritis and ankylosing spondylitis.

Although to date apremilast and dupilumab have been studied only in adults with atopic dermatitis, dermatologists who treat severely affected children are following the results with interest, because at present their main therapeutic options are heavy-hitting immunosuppressants, Dr. Tom noted.

She reported serving without financial compensation as an investigator for studies funded by Amgen and Anacor, which is developing AN2728 2% ointment. Dr. Tom was a member of the working group responsible for the 2014 AAD guidelines on atopic dermatitis.

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

bjancin@frontlinemedcom.com

WAIKOLOA, HAWAII – Fresh approaches for treating atopic dermatitis are sorely needed, and several intriguing novel therapies are under study, according to Dr. Wynnis Tom.

While topical corticosteroids continue to be the mainstay for control of the inflammation in atopic dermatitis, many patients and families have serious reservations about these medications. Patient concerns persist although, as emphasized in the updated 2014 American Academy of Dermatology guidelines for the management of atopic dermatitis (J. Am. Acad. Dermatol. 2014;70:338-51), these drugs have an excellent risk/benefit ratio when used appropriately.

It’s because of this widespread "steroid phobia" that AN2728 2% ointment is of particular interest, said Dr. Tom, a pediatric dermatologist at Rady Children’s Hospital and the University of California, San Diego.

AN2728 is a boron-based topical phosphodiesterase-4 inhibitor. The boron, she explained, provides added anti-inflammatory effects.

A recent phase I/II open-label, multicenter study involved 34 patients aged 2-17 years with mild to moderate atopic dermatitis and a 25%-35% body surface area of involvement. In this study, twice-daily application of AN2728 for 28 days resulted in 47% of participants achieving "clear" or "almost clear" on investigators’ global assessment, with at least a two-grade improvement from baseline. The affected body surface area plummeted by an average of 78%, while erythema, excoriations, and other symptoms also improved. Only one patient stopped therapy early.

A phase III trial is now in place. The big question relevant to clinical practice is, how does this agent compare in safety and efficacy to topical steroids and topical calcineurin inhibitors?

"We don’t know yet, but it’s nice to see there may be another class of anti-inflammatory agents we may be able to use, especially for those who are worried about topical steroids," Dr. Tom said at the SDEF Hawaii Dermatology Seminar sponsored by the Global Academy for Medical Education/Skin Disease Education Foundation.

For the minority of cases of atopic dermatitis that are more severe – and refractory to topical therapies – new agents in clinical trials include the oral phosphodiesterase-4 inhibitor apremilast and dupilumab, a monoclonal antibody that binds to the alpha subunit of the interleukin-4 receptor. Dupilumab, the first biologic agent to undergo evaluation for atopic dermatitis in a formal clinical trial, is now in a phase IIb trial involving adults with moderate to severe disease. Dupilumab is also under study for the treatment of other atopic diseases, including asthma.

Apremilast has been investigated in an open-label, prospective pilot study conducted by dermatologists at Oregon Health and Science University, Portland. The study included 16 adults with moderate to severe atopic dermatitis treated with oral apremilast at 20 or 30 mg b.i.d. for up to 6 months. Participants showed significant improvement on the Eczema Area and Severity Index, the Dermatology Life Quality Index, and other measures (Arch. Dermatol. 2012;148:890-7). Apremilast is approved as Otezla for the treatment of adults with psoriatic arthritis and is under study for other chronic inflammatory diseases, including rheumatoid arthritis and ankylosing spondylitis.

Although to date apremilast and dupilumab have been studied only in adults with atopic dermatitis, dermatologists who treat severely affected children are following the results with interest, because at present their main therapeutic options are heavy-hitting immunosuppressants, Dr. Tom noted.

She reported serving without financial compensation as an investigator for studies funded by Amgen and Anacor, which is developing AN2728 2% ointment. Dr. Tom was a member of the working group responsible for the 2014 AAD guidelines on atopic dermatitis.

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

bjancin@frontlinemedcom.com

WAIKOLOA, HAWAII – Fresh approaches for treating atopic dermatitis are sorely needed, and several intriguing novel therapies are under study, according to Dr. Wynnis Tom.

While topical corticosteroids continue to be the mainstay for control of the inflammation in atopic dermatitis, many patients and families have serious reservations about these medications. Patient concerns persist although, as emphasized in the updated 2014 American Academy of Dermatology guidelines for the management of atopic dermatitis (J. Am. Acad. Dermatol. 2014;70:338-51), these drugs have an excellent risk/benefit ratio when used appropriately.

It’s because of this widespread "steroid phobia" that AN2728 2% ointment is of particular interest, said Dr. Tom, a pediatric dermatologist at Rady Children’s Hospital and the University of California, San Diego.

AN2728 is a boron-based topical phosphodiesterase-4 inhibitor. The boron, she explained, provides added anti-inflammatory effects.

A recent phase I/II open-label, multicenter study involved 34 patients aged 2-17 years with mild to moderate atopic dermatitis and a 25%-35% body surface area of involvement. In this study, twice-daily application of AN2728 for 28 days resulted in 47% of participants achieving "clear" or "almost clear" on investigators’ global assessment, with at least a two-grade improvement from baseline. The affected body surface area plummeted by an average of 78%, while erythema, excoriations, and other symptoms also improved. Only one patient stopped therapy early.

A phase III trial is now in place. The big question relevant to clinical practice is, how does this agent compare in safety and efficacy to topical steroids and topical calcineurin inhibitors?

"We don’t know yet, but it’s nice to see there may be another class of anti-inflammatory agents we may be able to use, especially for those who are worried about topical steroids," Dr. Tom said at the SDEF Hawaii Dermatology Seminar sponsored by the Global Academy for Medical Education/Skin Disease Education Foundation.

For the minority of cases of atopic dermatitis that are more severe – and refractory to topical therapies – new agents in clinical trials include the oral phosphodiesterase-4 inhibitor apremilast and dupilumab, a monoclonal antibody that binds to the alpha subunit of the interleukin-4 receptor. Dupilumab, the first biologic agent to undergo evaluation for atopic dermatitis in a formal clinical trial, is now in a phase IIb trial involving adults with moderate to severe disease. Dupilumab is also under study for the treatment of other atopic diseases, including asthma.

Apremilast has been investigated in an open-label, prospective pilot study conducted by dermatologists at Oregon Health and Science University, Portland. The study included 16 adults with moderate to severe atopic dermatitis treated with oral apremilast at 20 or 30 mg b.i.d. for up to 6 months. Participants showed significant improvement on the Eczema Area and Severity Index, the Dermatology Life Quality Index, and other measures (Arch. Dermatol. 2012;148:890-7). Apremilast is approved as Otezla for the treatment of adults with psoriatic arthritis and is under study for other chronic inflammatory diseases, including rheumatoid arthritis and ankylosing spondylitis.

Although to date apremilast and dupilumab have been studied only in adults with atopic dermatitis, dermatologists who treat severely affected children are following the results with interest, because at present their main therapeutic options are heavy-hitting immunosuppressants, Dr. Tom noted.

She reported serving without financial compensation as an investigator for studies funded by Amgen and Anacor, which is developing AN2728 2% ointment. Dr. Tom was a member of the working group responsible for the 2014 AAD guidelines on atopic dermatitis.

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

bjancin@frontlinemedcom.com

WAIKOLOA, HAWAII – Fresh approaches for treating atopic dermatitis are sorely needed, and several intriguing novel therapies are under study, according to Dr. Wynnis Tom.

While topical corticosteroids continue to be the mainstay for control of the inflammation in atopic dermatitis, many patients and families have serious reservations about these medications. Patient concerns persist although, as emphasized in the updated 2014 American Academy of Dermatology guidelines for the management of atopic dermatitis (J. Am. Acad. Dermatol. 2014;70:338-51), these drugs have an excellent risk/benefit ratio when used appropriately.

It’s because of this widespread "steroid phobia" that AN2728 2% ointment is of particular interest, said Dr. Tom, a pediatric dermatologist at Rady Children’s Hospital and the University of California, San Diego.

AN2728 is a boron-based topical phosphodiesterase-4 inhibitor. The boron, she explained, provides added anti-inflammatory effects.

A recent phase I/II open-label, multicenter study involved 34 patients aged 2-17 years with mild to moderate atopic dermatitis and a 25%-35% body surface area of involvement. In this study, twice-daily application of AN2728 for 28 days resulted in 47% of participants achieving "clear" or "almost clear" on investigators’ global assessment, with at least a two-grade improvement from baseline. The affected body surface area plummeted by an average of 78%, while erythema, excoriations, and other symptoms also improved. Only one patient stopped therapy early.

A phase III trial is now in place. The big question relevant to clinical practice is, how does this agent compare in safety and efficacy to topical steroids and topical calcineurin inhibitors?

"We don’t know yet, but it’s nice to see there may be another class of anti-inflammatory agents we may be able to use, especially for those who are worried about topical steroids," Dr. Tom said at the SDEF Hawaii Dermatology Seminar sponsored by the Global Academy for Medical Education/Skin Disease Education Foundation.

For the minority of cases of atopic dermatitis that are more severe – and refractory to topical therapies – new agents in clinical trials include the oral phosphodiesterase-4 inhibitor apremilast and dupilumab, a monoclonal antibody that binds to the alpha subunit of the interleukin-4 receptor. Dupilumab, the first biologic agent to undergo evaluation for atopic dermatitis in a formal clinical trial, is now in a phase IIb trial involving adults with moderate to severe disease. Dupilumab is also under study for the treatment of other atopic diseases, including asthma.

Apremilast has been investigated in an open-label, prospective pilot study conducted by dermatologists at Oregon Health and Science University, Portland. The study included 16 adults with moderate to severe atopic dermatitis treated with oral apremilast at 20 or 30 mg b.i.d. for up to 6 months. Participants showed significant improvement on the Eczema Area and Severity Index, the Dermatology Life Quality Index, and other measures (Arch. Dermatol. 2012;148:890-7). Apremilast is approved as Otezla for the treatment of adults with psoriatic arthritis and is under study for other chronic inflammatory diseases, including rheumatoid arthritis and ankylosing spondylitis.

Although to date apremilast and dupilumab have been studied only in adults with atopic dermatitis, dermatologists who treat severely affected children are following the results with interest, because at present their main therapeutic options are heavy-hitting immunosuppressants, Dr. Tom noted.

She reported serving without financial compensation as an investigator for studies funded by Amgen and Anacor, which is developing AN2728 2% ointment. Dr. Tom was a member of the working group responsible for the 2014 AAD guidelines on atopic dermatitis.

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

bjancin@frontlinemedcom.com

WAIKOLOA, HAWAII – Fresh approaches for treating atopic dermatitis are sorely needed, and several intriguing novel therapies are under study, according to Dr. Wynnis Tom.

While topical corticosteroids continue to be the mainstay for control of the inflammation in atopic dermatitis, many patients and families have serious reservations about these medications. Patient concerns persist although, as emphasized in the updated 2014 American Academy of Dermatology guidelines for the management of atopic dermatitis (J. Am. Acad. Dermatol. 2014;70:338-51), these drugs have an excellent risk/benefit ratio when used appropriately.

It’s because of this widespread "steroid phobia" that AN2728 2% ointment is of particular interest, said Dr. Tom, a pediatric dermatologist at Rady Children’s Hospital and the University of California, San Diego.

AN2728 is a boron-based topical phosphodiesterase-4 inhibitor. The boron, she explained, provides added anti-inflammatory effects.

A recent phase I/II open-label, multicenter study involved 34 patients aged 2-17 years with mild to moderate atopic dermatitis and a 25%-35% body surface area of involvement. In this study, twice-daily application of AN2728 for 28 days resulted in 47% of participants achieving "clear" or "almost clear" on investigators’ global assessment, with at least a two-grade improvement from baseline. The affected body surface area plummeted by an average of 78%, while erythema, excoriations, and other symptoms also improved. Only one patient stopped therapy early.

A phase III trial is now in place. The big question relevant to clinical practice is, how does this agent compare in safety and efficacy to topical steroids and topical calcineurin inhibitors?

"We don’t know yet, but it’s nice to see there may be another class of anti-inflammatory agents we may be able to use, especially for those who are worried about topical steroids," Dr. Tom said at the SDEF Hawaii Dermatology Seminar sponsored by the Global Academy for Medical Education/Skin Disease Education Foundation.

For the minority of cases of atopic dermatitis that are more severe – and refractory to topical therapies – new agents in clinical trials include the oral phosphodiesterase-4 inhibitor apremilast and dupilumab, a monoclonal antibody that binds to the alpha subunit of the interleukin-4 receptor. Dupilumab, the first biologic agent to undergo evaluation for atopic dermatitis in a formal clinical trial, is now in a phase IIb trial involving adults with moderate to severe disease. Dupilumab is also under study for the treatment of other atopic diseases, including asthma.

Apremilast has been investigated in an open-label, prospective pilot study conducted by dermatologists at Oregon Health and Science University, Portland. The study included 16 adults with moderate to severe atopic dermatitis treated with oral apremilast at 20 or 30 mg b.i.d. for up to 6 months. Participants showed significant improvement on the Eczema Area and Severity Index, the Dermatology Life Quality Index, and other measures (Arch. Dermatol. 2012;148:890-7). Apremilast is approved as Otezla for the treatment of adults with psoriatic arthritis and is under study for other chronic inflammatory diseases, including rheumatoid arthritis and ankylosing spondylitis.

Although to date apremilast and dupilumab have been studied only in adults with atopic dermatitis, dermatologists who treat severely affected children are following the results with interest, because at present their main therapeutic options are heavy-hitting immunosuppressants, Dr. Tom noted.

She reported serving without financial compensation as an investigator for studies funded by Amgen and Anacor, which is developing AN2728 2% ointment. Dr. Tom was a member of the working group responsible for the 2014 AAD guidelines on atopic dermatitis.

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

bjancin@frontlinemedcom.com

WAIKOLOA, HAWAII – Fresh approaches for treating atopic dermatitis are sorely needed, and several intriguing novel therapies are under study, according to Dr. Wynnis Tom.

While topical corticosteroids continue to be the mainstay for control of the inflammation in atopic dermatitis, many patients and families have serious reservations about these medications. Patient concerns persist although, as emphasized in the updated 2014 American Academy of Dermatology guidelines for the management of atopic dermatitis (J. Am. Acad. Dermatol. 2014;70:338-51), these drugs have an excellent risk/benefit ratio when used appropriately.

It’s because of this widespread "steroid phobia" that AN2728 2% ointment is of particular interest, said Dr. Tom, a pediatric dermatologist at Rady Children’s Hospital and the University of California, San Diego.

AN2728 is a boron-based topical phosphodiesterase-4 inhibitor. The boron, she explained, provides added anti-inflammatory effects.

A recent phase I/II open-label, multicenter study involved 34 patients aged 2-17 years with mild to moderate atopic dermatitis and a 25%-35% body surface area of involvement. In this study, twice-daily application of AN2728 for 28 days resulted in 47% of participants achieving "clear" or "almost clear" on investigators’ global assessment, with at least a two-grade improvement from baseline. The affected body surface area plummeted by an average of 78%, while erythema, excoriations, and other symptoms also improved. Only one patient stopped therapy early.

A phase III trial is now in place. The big question relevant to clinical practice is, how does this agent compare in safety and efficacy to topical steroids and topical calcineurin inhibitors?

"We don’t know yet, but it’s nice to see there may be another class of anti-inflammatory agents we may be able to use, especially for those who are worried about topical steroids," Dr. Tom said at the SDEF Hawaii Dermatology Seminar sponsored by the Global Academy for Medical Education/Skin Disease Education Foundation.

For the minority of cases of atopic dermatitis that are more severe – and refractory to topical therapies – new agents in clinical trials include the oral phosphodiesterase-4 inhibitor apremilast and dupilumab, a monoclonal antibody that binds to the alpha subunit of the interleukin-4 receptor. Dupilumab, the first biologic agent to undergo evaluation for atopic dermatitis in a formal clinical trial, is now in a phase IIb trial involving adults with moderate to severe disease. Dupilumab is also under study for the treatment of other atopic diseases, including asthma.

Apremilast has been investigated in an open-label, prospective pilot study conducted by dermatologists at Oregon Health and Science University, Portland. The study included 16 adults with moderate to severe atopic dermatitis treated with oral apremilast at 20 or 30 mg b.i.d. for up to 6 months. Participants showed significant improvement on the Eczema Area and Severity Index, the Dermatology Life Quality Index, and other measures (Arch. Dermatol. 2012;148:890-7). Apremilast is approved as Otezla for the treatment of adults with psoriatic arthritis and is under study for other chronic inflammatory diseases, including rheumatoid arthritis and ankylosing spondylitis.

Although to date apremilast and dupilumab have been studied only in adults with atopic dermatitis, dermatologists who treat severely affected children are following the results with interest, because at present their main therapeutic options are heavy-hitting immunosuppressants, Dr. Tom noted.

She reported serving without financial compensation as an investigator for studies funded by Amgen and Anacor, which is developing AN2728 2% ointment. Dr. Tom was a member of the working group responsible for the 2014 AAD guidelines on atopic dermatitis.

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

bjancin@frontlinemedcom.com

WAIKOLOA, HAWAII – Half of patients whose face or scalp actinic keratoses clear completely in response to 3 consecutive days of topical field therapy with ingenol mebutate gel 0.015% will remain clear 12 months later with no further treatment.

That finding from a multicenter prospective study is just one of several recent developments of note in the treatment of actinic keratoses. Other recent studies have addressed the effectiveness of fractional laser therapy and cryotherapy followed by ingenol mebutate, and there have been new developments in phototherapy, Dr. James E. Sligh said in a review of actinic keratosis research at the Hawaii Dermatology Seminar sponsored by the Global Academy for Medical Education/Skin Disease Education Foundation.

• Long-term follow-up of ingenol mebutate therapy. In a multicenter study, dermatologists followed 100 patients with complete clearance of AKs on the face or scalp in response to 3 consecutive days of ingenol mebutate gel (Picato) and 71 patients whose AKs on the trunk or limbs cleared after 2 consecutive days of therapy. The sustained lesion reduction rate, compared with pretreatment baseline was 87.2% for the face and scalp lesions and 86.8% for AKs on the trunk or extremities.

The median time to recurrence was 365 days for AKs on the face and scalp, and shorter at 274 days for lesions on the trunk or extremities, which notably had received 1 less day of treatment. No safety concerns arose during follow-up (JAMA Dermatol. 2013;149:666-70).

• Sequential cryosurgery followed by ingenol mebutate. In a randomized, double-blind, multicenter phase-III trial, 329 patients were randomized to field therapy of AKs on the face or scalp with ingenol mebutate or vehicle 3 weeks after cryosurgery. The complete clearance rate in the treated area at week 11 was significantly higher in the sequential therapy group: 60.5%, compared with 49.4% with cryosurgery alone (J. Drugs Dermatol. 2014;13:154-60).

"I think this is the first in what will be a number of studies where you start to see assessment of combined therapies. But I think the target to look at is not so much what happens at 11 weeks, as in this study, but what happens 1 or 2 years down the road. If you can maintain complete clearance for that long I think it’s worth the extra effort to combine treatment cycles at the beginning," commented Dr. Sligh, chief of the division of dermatology at the University of Arizona, Tucson.

• Laser therapy. Investigators at the Laser and Skin Surgery Center of New York investigated treatment of facial AKs using a fractionated 1927-nm nonablative thulium laser. Twenty-four patients received up to four fractional resurfacing treatments in this prospective trial. At 6 months follow-up, the AK lesion count was down 87%, compared with baseline. Patient satisfaction was high – all participants reported marked or noticeable improvement in overall photodamage – and treatment was well tolerated (J. Am. Acad. Dermatol. 2013;68:98-102).

"If you look at the reduction in AK counts, it stands up very nicely to some of our medical therapies in terms of overall clearance at 6 months, with an 87% reduction – provided you have this special thulium laser in your office," Dr. Sligh observed.

• Photodynamic therapy. What’s new in photodynamic therapy for AKs is not currently available in the United States: methyl aminolevulinate cream 16.8% (Metvixia) for use with red light illumination. This photosensitizer does remain available, however, in Canada and Mexico, according to Dr. Sligh. And aminolevulinic acid (Levulan) is still available as an approved photosensitizer for use with blue light.

"There are many people I know who will activate the Levulan with either a red or blue light source," he said.

Dr. Sligh is on the advisory board for and a consultant to Genentech and has received research grants from DermSpectra and Scibase.

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

bjancin@frontlinemedcom.com

WAIKOLOA, HAWAII – Half of patients whose face or scalp actinic keratoses clear completely in response to 3 consecutive days of topical field therapy with ingenol mebutate gel 0.015% will remain clear 12 months later with no further treatment.

That finding from a multicenter prospective study is just one of several recent developments of note in the treatment of actinic keratoses. Other recent studies have addressed the effectiveness of fractional laser therapy and cryotherapy followed by ingenol mebutate, and there have been new developments in phototherapy, Dr. James E. Sligh said in a review of actinic keratosis research at the Hawaii Dermatology Seminar sponsored by the Global Academy for Medical Education/Skin Disease Education Foundation.

• Long-term follow-up of ingenol mebutate therapy. In a multicenter study, dermatologists followed 100 patients with complete clearance of AKs on the face or scalp in response to 3 consecutive days of ingenol mebutate gel (Picato) and 71 patients whose AKs on the trunk or limbs cleared after 2 consecutive days of therapy. The sustained lesion reduction rate, compared with pretreatment baseline was 87.2% for the face and scalp lesions and 86.8% for AKs on the trunk or extremities.

The median time to recurrence was 365 days for AKs on the face and scalp, and shorter at 274 days for lesions on the trunk or extremities, which notably had received 1 less day of treatment. No safety concerns arose during follow-up (JAMA Dermatol. 2013;149:666-70).

• Sequential cryosurgery followed by ingenol mebutate. In a randomized, double-blind, multicenter phase-III trial, 329 patients were randomized to field therapy of AKs on the face or scalp with ingenol mebutate or vehicle 3 weeks after cryosurgery. The complete clearance rate in the treated area at week 11 was significantly higher in the sequential therapy group: 60.5%, compared with 49.4% with cryosurgery alone (J. Drugs Dermatol. 2014;13:154-60).

"I think this is the first in what will be a number of studies where you start to see assessment of combined therapies. But I think the target to look at is not so much what happens at 11 weeks, as in this study, but what happens 1 or 2 years down the road. If you can maintain complete clearance for that long I think it’s worth the extra effort to combine treatment cycles at the beginning," commented Dr. Sligh, chief of the division of dermatology at the University of Arizona, Tucson.

• Laser therapy. Investigators at the Laser and Skin Surgery Center of New York investigated treatment of facial AKs using a fractionated 1927-nm nonablative thulium laser. Twenty-four patients received up to four fractional resurfacing treatments in this prospective trial. At 6 months follow-up, the AK lesion count was down 87%, compared with baseline. Patient satisfaction was high – all participants reported marked or noticeable improvement in overall photodamage – and treatment was well tolerated (J. Am. Acad. Dermatol. 2013;68:98-102).

"If you look at the reduction in AK counts, it stands up very nicely to some of our medical therapies in terms of overall clearance at 6 months, with an 87% reduction – provided you have this special thulium laser in your office," Dr. Sligh observed.

• Photodynamic therapy. What’s new in photodynamic therapy for AKs is not currently available in the United States: methyl aminolevulinate cream 16.8% (Metvixia) for use with red light illumination. This photosensitizer does remain available, however, in Canada and Mexico, according to Dr. Sligh. And aminolevulinic acid (Levulan) is still available as an approved photosensitizer for use with blue light.

"There are many people I know who will activate the Levulan with either a red or blue light source," he said.

Dr. Sligh is on the advisory board for and a consultant to Genentech and has received research grants from DermSpectra and Scibase.

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

bjancin@frontlinemedcom.com

WAIKOLOA, HAWAII – Half of patients whose face or scalp actinic keratoses clear completely in response to 3 consecutive days of topical field therapy with ingenol mebutate gel 0.015% will remain clear 12 months later with no further treatment.

That finding from a multicenter prospective study is just one of several recent developments of note in the treatment of actinic keratoses. Other recent studies have addressed the effectiveness of fractional laser therapy and cryotherapy followed by ingenol mebutate, and there have been new developments in phototherapy, Dr. James E. Sligh said in a review of actinic keratosis research at the Hawaii Dermatology Seminar sponsored by the Global Academy for Medical Education/Skin Disease Education Foundation.

• Long-term follow-up of ingenol mebutate therapy. In a multicenter study, dermatologists followed 100 patients with complete clearance of AKs on the face or scalp in response to 3 consecutive days of ingenol mebutate gel (Picato) and 71 patients whose AKs on the trunk or limbs cleared after 2 consecutive days of therapy. The sustained lesion reduction rate, compared with pretreatment baseline was 87.2% for the face and scalp lesions and 86.8% for AKs on the trunk or extremities.

The median time to recurrence was 365 days for AKs on the face and scalp, and shorter at 274 days for lesions on the trunk or extremities, which notably had received 1 less day of treatment. No safety concerns arose during follow-up (JAMA Dermatol. 2013;149:666-70).

• Sequential cryosurgery followed by ingenol mebutate. In a randomized, double-blind, multicenter phase-III trial, 329 patients were randomized to field therapy of AKs on the face or scalp with ingenol mebutate or vehicle 3 weeks after cryosurgery. The complete clearance rate in the treated area at week 11 was significantly higher in the sequential therapy group: 60.5%, compared with 49.4% with cryosurgery alone (J. Drugs Dermatol. 2014;13:154-60).

"I think this is the first in what will be a number of studies where you start to see assessment of combined therapies. But I think the target to look at is not so much what happens at 11 weeks, as in this study, but what happens 1 or 2 years down the road. If you can maintain complete clearance for that long I think it’s worth the extra effort to combine treatment cycles at the beginning," commented Dr. Sligh, chief of the division of dermatology at the University of Arizona, Tucson.

• Laser therapy. Investigators at the Laser and Skin Surgery Center of New York investigated treatment of facial AKs using a fractionated 1927-nm nonablative thulium laser. Twenty-four patients received up to four fractional resurfacing treatments in this prospective trial. At 6 months follow-up, the AK lesion count was down 87%, compared with baseline. Patient satisfaction was high – all participants reported marked or noticeable improvement in overall photodamage – and treatment was well tolerated (J. Am. Acad. Dermatol. 2013;68:98-102).

"If you look at the reduction in AK counts, it stands up very nicely to some of our medical therapies in terms of overall clearance at 6 months, with an 87% reduction – provided you have this special thulium laser in your office," Dr. Sligh observed.

• Photodynamic therapy. What’s new in photodynamic therapy for AKs is not currently available in the United States: methyl aminolevulinate cream 16.8% (Metvixia) for use with red light illumination. This photosensitizer does remain available, however, in Canada and Mexico, according to Dr. Sligh. And aminolevulinic acid (Levulan) is still available as an approved photosensitizer for use with blue light.

"There are many people I know who will activate the Levulan with either a red or blue light source," he said.

Dr. Sligh is on the advisory board for and a consultant to Genentech and has received research grants from DermSpectra and Scibase.

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

bjancin@frontlinemedcom.com

WAIKOLOA, HAWAII – The spectacular developments in the treatment of advanced melanoma that began with approval of ipilimumab in 2011 continue to accelerate, and these advances promise to keep dermatologists quite busy for the foreseeable future in treating the cutaneous side effects of these targeted therapies.

Cutaneous toxicities requiring medical attention are extremely common with the new therapeutic agents. The key to minimizing their effects is proactive management, Dr. James E. Sligh emphasized at the Hawaii Dermatology Seminar sponsored by Global Academy for Medical Education/Skin Disease Education Foundation.

Bruce Jancin/Frontline Medical News

"The message is that people are living longer with advanced melanoma, but you really need to work with your oncologists to get the absolute benefit patients deserve out of these advanced drugs," he said. "All patients on any of the BRAF inhibitors should receive a dermatologic evaluation prior to initiation of therapy, every 2 months while on therapy, and for 6 months following treatment discontinuation. And while I use this as a guide, there are definitely patients I see for whom 2 months is way too long between visits," he added. "If they’re growing squamous cell carcinomas or verrucous keratoses at a good clip, they need to be seen more often. I’ll see them every other week if need be," said Dr. Sligh, chief of the dermatology division at the University of Arizona, Tucson.

"This is a plea to dermatologists," he continued. "If you have a patient who’s going on a BRAF inhibitor, they need to be seen in your office regularly. And if your next available appointment isn’t until 4 months down the road, you absolutely need to make room for these patients, because after 4 months they may have very large squamous cell carcinomas."

One in four advanced melanoma patients on a BRAF inhibitor – vemurafenib and dabrenafib are the two available thus far – will develop squamous cell carcinomas, Dr. Sligh said. If it’s going to happen, it typically begins in the first month or two of therapy. Caught early, the treatment is simple removal. The same goes for verrucous keratoses, which occur in close to half of treated patients.

"I use cryotherapy in the office, and I give patients 5-FU [5-fluorouracil] so they can start treating a lesion the day they see it, rather than waiting to show it to me a couple of months later," explained Dr. Sligh.

Other common cutaneous adverse events seen as a class effect with the BRAF inhibitors include photosensitivity reactions, seen in approximately one-third of patients in the phase III clinical trials; pruritus, seen in 23%; plantar hyperkeratosis in 10%-20%; and maculopapular rash in 9%.

The pretreatment dermatologic visit is an ideal time for patient education regarding sunscreen use, protective clothing, and the necessity to stay indoors in the event a photosensitivity rash emerges, Dr. Sligh noted. These are issues medical oncologists typically won’t counsel patients about, he said.

"The real advantage to doing this is you want these patients to maintain their optimal dose. For vemurafenib, it’s 960 mg b.i.d. There are very few things that will cause a dose reduction with these drugs, so if cutaneous toxicity is something patients are having a difficult time with, it’s our job as dermatologists to ensure that they have the best chance to make those side effects tolerable. Remaining on the drug is absolutely their best chance for survival," Dr. Sligh continued.

Serious hypersensitivity reactions, including anaphylaxis, as well as Stevens-Johnson syndrome and toxic epidermal necrolysis, have been reported in patients on a BRAF inhibitor. Such events do require permanent discontinuation of therapy. But that’s not necessarily the end of the road. "There are fantastic new options coming on board each year as alternatives for these people," according to Dr. Sligh.

New primary melanomas can arise while a patient is on BRAF inhibitor therapy. If they are detected early through those bimonthly office visits, the treatment is excision with no dosage adjustment.

Ipilimumab, which targets cytotoxic T-lymphocyte antigen 4, differs from the BRAF inhibitors in that its cutaneous adverse effects can emerge long after the drug is stopped.

"If you see a rash that’s not typical in a patient even 1 or 2 years after they were on ipilimumab, you should still consider that drug to be a likely culprit," Dr. Sligh said.

Trametinib, a MEK inhibitor, was approved last year for the treatment of melanomas with BRAF V600E or V600K mutations. Cutaneous toxicity occurs in close to 90% of patients on the drug, including a 12% rate of severe, grade 3 skin reactions. When trametinib is given in combination with vemurafenib or dabrafenib in an effort to delay emergence of tumor resistance, the result is longer progression-free survival than with either agent alone, and with a lower rate of squamous cell carcinomas and other cutaneous adverse events than with either agent as monotherapy. However, the question of whether or not combination therapy improves overall survival remains unclear, and is the subject of ongoing trials.

Close to half of melanoma patients have a BRAF mutation that makes them a potential candidate for BRAF inhibitor therapy. But in a separate presentation at the meeting, Dr. Michael Postow, an oncologist at Memorial Sloan Kettering Cancer Center in New York, urged dermatologists not to think only of the FDA-approved BRAF test when they have a patient diagnosed with melanoma.

"It’s really worthwhile to do more extensive molecular profiling of those patients, because you may find another targetable mutation," said Dr. Postow. "I would encourage you to refer any patients you have that are being diagnosed with melanoma for a larger institutional evaluation where more extensive molecular characterization of the tumor can be performed," he added.

Dr. Sligh is on the advisory board for and a consultant to Genentech, and he has received research grants from DermSpectra and SciBase. Dr. Postow reported serving as an unpaid adviser to Bristol-Myers Squibb.

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

bjancin@frontlinemedcom.com

WAIKOLOA, HAWAII – The spectacular developments in the treatment of advanced melanoma that began with approval of ipilimumab in 2011 continue to accelerate, and these advances promise to keep dermatologists quite busy for the foreseeable future in treating the cutaneous side effects of these targeted therapies.

Cutaneous toxicities requiring medical attention are extremely common with the new therapeutic agents. The key to minimizing their effects is proactive management, Dr. James E. Sligh emphasized at the Hawaii Dermatology Seminar sponsored by Global Academy for Medical Education/Skin Disease Education Foundation.

Bruce Jancin/Frontline Medical News

"The message is that people are living longer with advanced melanoma, but you really need to work with your oncologists to get the absolute benefit patients deserve out of these advanced drugs," he said. "All patients on any of the BRAF inhibitors should receive a dermatologic evaluation prior to initiation of therapy, every 2 months while on therapy, and for 6 months following treatment discontinuation. And while I use this as a guide, there are definitely patients I see for whom 2 months is way too long between visits," he added. "If they’re growing squamous cell carcinomas or verrucous keratoses at a good clip, they need to be seen more often. I’ll see them every other week if need be," said Dr. Sligh, chief of the dermatology division at the University of Arizona, Tucson.

"This is a plea to dermatologists," he continued. "If you have a patient who’s going on a BRAF inhibitor, they need to be seen in your office regularly. And if your next available appointment isn’t until 4 months down the road, you absolutely need to make room for these patients, because after 4 months they may have very large squamous cell carcinomas."

One in four advanced melanoma patients on a BRAF inhibitor – vemurafenib and dabrenafib are the two available thus far – will develop squamous cell carcinomas, Dr. Sligh said. If it’s going to happen, it typically begins in the first month or two of therapy. Caught early, the treatment is simple removal. The same goes for verrucous keratoses, which occur in close to half of treated patients.

"I use cryotherapy in the office, and I give patients 5-FU [5-fluorouracil] so they can start treating a lesion the day they see it, rather than waiting to show it to me a couple of months later," explained Dr. Sligh.

Other common cutaneous adverse events seen as a class effect with the BRAF inhibitors include photosensitivity reactions, seen in approximately one-third of patients in the phase III clinical trials; pruritus, seen in 23%; plantar hyperkeratosis in 10%-20%; and maculopapular rash in 9%.

The pretreatment dermatologic visit is an ideal time for patient education regarding sunscreen use, protective clothing, and the necessity to stay indoors in the event a photosensitivity rash emerges, Dr. Sligh noted. These are issues medical oncologists typically won’t counsel patients about, he said.

"The real advantage to doing this is you want these patients to maintain their optimal dose. For vemurafenib, it’s 960 mg b.i.d. There are very few things that will cause a dose reduction with these drugs, so if cutaneous toxicity is something patients are having a difficult time with, it’s our job as dermatologists to ensure that they have the best chance to make those side effects tolerable. Remaining on the drug is absolutely their best chance for survival," Dr. Sligh continued.

Serious hypersensitivity reactions, including anaphylaxis, as well as Stevens-Johnson syndrome and toxic epidermal necrolysis, have been reported in patients on a BRAF inhibitor. Such events do require permanent discontinuation of therapy. But that’s not necessarily the end of the road. "There are fantastic new options coming on board each year as alternatives for these people," according to Dr. Sligh.

New primary melanomas can arise while a patient is on BRAF inhibitor therapy. If they are detected early through those bimonthly office visits, the treatment is excision with no dosage adjustment.

Ipilimumab, which targets cytotoxic T-lymphocyte antigen 4, differs from the BRAF inhibitors in that its cutaneous adverse effects can emerge long after the drug is stopped.

"If you see a rash that’s not typical in a patient even 1 or 2 years after they were on ipilimumab, you should still consider that drug to be a likely culprit," Dr. Sligh said.

Trametinib, a MEK inhibitor, was approved last year for the treatment of melanomas with BRAF V600E or V600K mutations. Cutaneous toxicity occurs in close to 90% of patients on the drug, including a 12% rate of severe, grade 3 skin reactions. When trametinib is given in combination with vemurafenib or dabrafenib in an effort to delay emergence of tumor resistance, the result is longer progression-free survival than with either agent alone, and with a lower rate of squamous cell carcinomas and other cutaneous adverse events than with either agent as monotherapy. However, the question of whether or not combination therapy improves overall survival remains unclear, and is the subject of ongoing trials.

Close to half of melanoma patients have a BRAF mutation that makes them a potential candidate for BRAF inhibitor therapy. But in a separate presentation at the meeting, Dr. Michael Postow, an oncologist at Memorial Sloan Kettering Cancer Center in New York, urged dermatologists not to think only of the FDA-approved BRAF test when they have a patient diagnosed with melanoma.

"It’s really worthwhile to do more extensive molecular profiling of those patients, because you may find another targetable mutation," said Dr. Postow. "I would encourage you to refer any patients you have that are being diagnosed with melanoma for a larger institutional evaluation where more extensive molecular characterization of the tumor can be performed," he added.

Dr. Sligh is on the advisory board for and a consultant to Genentech, and he has received research grants from DermSpectra and SciBase. Dr. Postow reported serving as an unpaid adviser to Bristol-Myers Squibb.

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

bjancin@frontlinemedcom.com

WAIKOLOA, HAWAII – The spectacular developments in the treatment of advanced melanoma that began with approval of ipilimumab in 2011 continue to accelerate, and these advances promise to keep dermatologists quite busy for the foreseeable future in treating the cutaneous side effects of these targeted therapies.

Cutaneous toxicities requiring medical attention are extremely common with the new therapeutic agents. The key to minimizing their effects is proactive management, Dr. James E. Sligh emphasized at the Hawaii Dermatology Seminar sponsored by Global Academy for Medical Education/Skin Disease Education Foundation.

Bruce Jancin/Frontline Medical News

"The message is that people are living longer with advanced melanoma, but you really need to work with your oncologists to get the absolute benefit patients deserve out of these advanced drugs," he said. "All patients on any of the BRAF inhibitors should receive a dermatologic evaluation prior to initiation of therapy, every 2 months while on therapy, and for 6 months following treatment discontinuation. And while I use this as a guide, there are definitely patients I see for whom 2 months is way too long between visits," he added. "If they’re growing squamous cell carcinomas or verrucous keratoses at a good clip, they need to be seen more often. I’ll see them every other week if need be," said Dr. Sligh, chief of the dermatology division at the University of Arizona, Tucson.

"This is a plea to dermatologists," he continued. "If you have a patient who’s going on a BRAF inhibitor, they need to be seen in your office regularly. And if your next available appointment isn’t until 4 months down the road, you absolutely need to make room for these patients, because after 4 months they may have very large squamous cell carcinomas."

One in four advanced melanoma patients on a BRAF inhibitor – vemurafenib and dabrenafib are the two available thus far – will develop squamous cell carcinomas, Dr. Sligh said. If it’s going to happen, it typically begins in the first month or two of therapy. Caught early, the treatment is simple removal. The same goes for verrucous keratoses, which occur in close to half of treated patients.

"I use cryotherapy in the office, and I give patients 5-FU [5-fluorouracil] so they can start treating a lesion the day they see it, rather than waiting to show it to me a couple of months later," explained Dr. Sligh.

Other common cutaneous adverse events seen as a class effect with the BRAF inhibitors include photosensitivity reactions, seen in approximately one-third of patients in the phase III clinical trials; pruritus, seen in 23%; plantar hyperkeratosis in 10%-20%; and maculopapular rash in 9%.

The pretreatment dermatologic visit is an ideal time for patient education regarding sunscreen use, protective clothing, and the necessity to stay indoors in the event a photosensitivity rash emerges, Dr. Sligh noted. These are issues medical oncologists typically won’t counsel patients about, he said.

"The real advantage to doing this is you want these patients to maintain their optimal dose. For vemurafenib, it’s 960 mg b.i.d. There are very few things that will cause a dose reduction with these drugs, so if cutaneous toxicity is something patients are having a difficult time with, it’s our job as dermatologists to ensure that they have the best chance to make those side effects tolerable. Remaining on the drug is absolutely their best chance for survival," Dr. Sligh continued.

Serious hypersensitivity reactions, including anaphylaxis, as well as Stevens-Johnson syndrome and toxic epidermal necrolysis, have been reported in patients on a BRAF inhibitor. Such events do require permanent discontinuation of therapy. But that’s not necessarily the end of the road. "There are fantastic new options coming on board each year as alternatives for these people," according to Dr. Sligh.

New primary melanomas can arise while a patient is on BRAF inhibitor therapy. If they are detected early through those bimonthly office visits, the treatment is excision with no dosage adjustment.

Ipilimumab, which targets cytotoxic T-lymphocyte antigen 4, differs from the BRAF inhibitors in that its cutaneous adverse effects can emerge long after the drug is stopped.

"If you see a rash that’s not typical in a patient even 1 or 2 years after they were on ipilimumab, you should still consider that drug to be a likely culprit," Dr. Sligh said.

Trametinib, a MEK inhibitor, was approved last year for the treatment of melanomas with BRAF V600E or V600K mutations. Cutaneous toxicity occurs in close to 90% of patients on the drug, including a 12% rate of severe, grade 3 skin reactions. When trametinib is given in combination with vemurafenib or dabrafenib in an effort to delay emergence of tumor resistance, the result is longer progression-free survival than with either agent alone, and with a lower rate of squamous cell carcinomas and other cutaneous adverse events than with either agent as monotherapy. However, the question of whether or not combination therapy improves overall survival remains unclear, and is the subject of ongoing trials.

Close to half of melanoma patients have a BRAF mutation that makes them a potential candidate for BRAF inhibitor therapy. But in a separate presentation at the meeting, Dr. Michael Postow, an oncologist at Memorial Sloan Kettering Cancer Center in New York, urged dermatologists not to think only of the FDA-approved BRAF test when they have a patient diagnosed with melanoma.

"It’s really worthwhile to do more extensive molecular profiling of those patients, because you may find another targetable mutation," said Dr. Postow. "I would encourage you to refer any patients you have that are being diagnosed with melanoma for a larger institutional evaluation where more extensive molecular characterization of the tumor can be performed," he added.

Dr. Sligh is on the advisory board for and a consultant to Genentech, and he has received research grants from DermSpectra and SciBase. Dr. Postow reported serving as an unpaid adviser to Bristol-Myers Squibb.

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

bjancin@frontlinemedcom.com

WAIKOLOA, HAWAII – The fixed-dose combination of adapalene/benzoyl peroxide gel 0.1%/2.5% typically results in reductions of 40%-50% in inflammatory and 30%-40% in noninflammatory acne lesion counts during the first 4 weeks of therapy.

In a pooled analysis of 14 studies totaling 2,358 acne patients aged 9-61 years, the proportion with an Investigator’s Global Assessment (IGA) of moderate or severe acne dropped from 92% at baseline to 51% at 4 weeks, according to Dr. Linda Stein Gold.

The pooled analysis was carried out to provide physicians and patients with information as to what to realistically expect in the first 4 weeks of therapy. The analysis is particularly timely in light of the Food and Drug Administration’s recent expansion of the indication for adapalene/benzoyl peroxide gel 0.1%/2.5% (Epiduo) to include acne patients as young as 9 years of age, noted Dr. Stein Gold, director of clinical research in the department of dermatology at Henry Ford Hospital, Detroit.

Mild skin irritation was common, especially in the first 2 weeks of use.

"It’s a fiction that retinoids are too harsh for younger patients to use," Dr. Stein Gold said. "I tell all my acne patients, especially the younger ones, no matter what topical retinoid they’re using, to use it every other night for the first 2 weeks, make sure their skin is completely dry, and use a gentle cleanser and a good moisturizer," she said at the Hawaii Dermatology Seminar sponsored by Global Academy for Medical Education/Skin Disease Education Foundation. "If they get through those first 2 weeks, they’ll see that the tolerability really improves."

Dr. Stein Gold said she likes the fixed combination of adapalene/benzoyl peroxide gel 0.1%/2.5% because it combines several key elements of cutting-edge acne treatment. Topical retinoids are not mere comedone busters, as formerly thought, but are also effective agents for papules and pustular lesions. While they do not kill Propionibacterium acnes, they down-regulate Toll-like receptor 2, which is produced by the bacterium and induces proinflammatory cytokines. Topical retinoids are a key part of maintenance-of-remission strategies. And adapalene is unique among topical retinoids in that it is inherently stable with benzoyl peroxide (BPO) and is stable in daylight.

BPO is unique in that it has potent antibacterial activity, but never causes P. acnes resistance, even after many years of treatment. BPO is quite effective for inflammatory lesions and moderately effective for comedonal acne lesions, Dr. Stein Gold noted. Also, it is well established that BPO at a concentration of 2.5% is as efficacious as 5% or 10%, and much better tolerated than at the higher concentrations. The molecule size and the use of a vehicle with good penetration into the hair follicle are much more important factors in treatment effectiveness than is the BPO concentration, she added.

In one study of acne patients with antibiotic-resistant P. acnes, including clindamycin-, doxycycline-, erythromycin-, and minocycline-resistant microorganisms, 88% of the antibiotic-resistant P. acnes bacteria were killed after 2 weeks of treatment with adapalene/BPO gel 0.1%/2.5%. After 4 weeks of treatment, 97% of the antibiotic-resistant organisms were dead. That’s testimony to the P. acnes–killing power of BPO, said Dr. Stein Gold.

"There’s a sense among many that with all the newer medications we have for acne, benzoyl peroxide is really your grandfather’s treatment, with no place in today’s modern world. This is totally false. I really feel that benzoyl peroxide should play a central role in all of our acne patients’ treatment regimens, unless of course they’re allergic to it, which occurs in only a small percentage of our patients," she said.

The pooled analysis was funded by Galderma. Dr. Stein Gold is a consultant to Galderma, Stiefel, Medicis, and Warner Chilcott.

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

bjancin@frontlinemedcom.com

WAIKOLOA, HAWAII – The fixed-dose combination of adapalene/benzoyl peroxide gel 0.1%/2.5% typically results in reductions of 40%-50% in inflammatory and 30%-40% in noninflammatory acne lesion counts during the first 4 weeks of therapy.

In a pooled analysis of 14 studies totaling 2,358 acne patients aged 9-61 years, the proportion with an Investigator’s Global Assessment (IGA) of moderate or severe acne dropped from 92% at baseline to 51% at 4 weeks, according to Dr. Linda Stein Gold.

The pooled analysis was carried out to provide physicians and patients with information as to what to realistically expect in the first 4 weeks of therapy. The analysis is particularly timely in light of the Food and Drug Administration’s recent expansion of the indication for adapalene/benzoyl peroxide gel 0.1%/2.5% (Epiduo) to include acne patients as young as 9 years of age, noted Dr. Stein Gold, director of clinical research in the department of dermatology at Henry Ford Hospital, Detroit.

Mild skin irritation was common, especially in the first 2 weeks of use.

"It’s a fiction that retinoids are too harsh for younger patients to use," Dr. Stein Gold said. "I tell all my acne patients, especially the younger ones, no matter what topical retinoid they’re using, to use it every other night for the first 2 weeks, make sure their skin is completely dry, and use a gentle cleanser and a good moisturizer," she said at the Hawaii Dermatology Seminar sponsored by Global Academy for Medical Education/Skin Disease Education Foundation. "If they get through those first 2 weeks, they’ll see that the tolerability really improves."

Dr. Stein Gold said she likes the fixed combination of adapalene/benzoyl peroxide gel 0.1%/2.5% because it combines several key elements of cutting-edge acne treatment. Topical retinoids are not mere comedone busters, as formerly thought, but are also effective agents for papules and pustular lesions. While they do not kill Propionibacterium acnes, they down-regulate Toll-like receptor 2, which is produced by the bacterium and induces proinflammatory cytokines. Topical retinoids are a key part of maintenance-of-remission strategies. And adapalene is unique among topical retinoids in that it is inherently stable with benzoyl peroxide (BPO) and is stable in daylight.

BPO is unique in that it has potent antibacterial activity, but never causes P. acnes resistance, even after many years of treatment. BPO is quite effective for inflammatory lesions and moderately effective for comedonal acne lesions, Dr. Stein Gold noted. Also, it is well established that BPO at a concentration of 2.5% is as efficacious as 5% or 10%, and much better tolerated than at the higher concentrations. The molecule size and the use of a vehicle with good penetration into the hair follicle are much more important factors in treatment effectiveness than is the BPO concentration, she added.

In one study of acne patients with antibiotic-resistant P. acnes, including clindamycin-, doxycycline-, erythromycin-, and minocycline-resistant microorganisms, 88% of the antibiotic-resistant P. acnes bacteria were killed after 2 weeks of treatment with adapalene/BPO gel 0.1%/2.5%. After 4 weeks of treatment, 97% of the antibiotic-resistant organisms were dead. That’s testimony to the P. acnes–killing power of BPO, said Dr. Stein Gold.

"There’s a sense among many that with all the newer medications we have for acne, benzoyl peroxide is really your grandfather’s treatment, with no place in today’s modern world. This is totally false. I really feel that benzoyl peroxide should play a central role in all of our acne patients’ treatment regimens, unless of course they’re allergic to it, which occurs in only a small percentage of our patients," she said.

The pooled analysis was funded by Galderma. Dr. Stein Gold is a consultant to Galderma, Stiefel, Medicis, and Warner Chilcott.

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

bjancin@frontlinemedcom.com

WAIKOLOA, HAWAII – The fixed-dose combination of adapalene/benzoyl peroxide gel 0.1%/2.5% typically results in reductions of 40%-50% in inflammatory and 30%-40% in noninflammatory acne lesion counts during the first 4 weeks of therapy.

In a pooled analysis of 14 studies totaling 2,358 acne patients aged 9-61 years, the proportion with an Investigator’s Global Assessment (IGA) of moderate or severe acne dropped from 92% at baseline to 51% at 4 weeks, according to Dr. Linda Stein Gold.

The pooled analysis was carried out to provide physicians and patients with information as to what to realistically expect in the first 4 weeks of therapy. The analysis is particularly timely in light of the Food and Drug Administration’s recent expansion of the indication for adapalene/benzoyl peroxide gel 0.1%/2.5% (Epiduo) to include acne patients as young as 9 years of age, noted Dr. Stein Gold, director of clinical research in the department of dermatology at Henry Ford Hospital, Detroit.

Mild skin irritation was common, especially in the first 2 weeks of use.

"It’s a fiction that retinoids are too harsh for younger patients to use," Dr. Stein Gold said. "I tell all my acne patients, especially the younger ones, no matter what topical retinoid they’re using, to use it every other night for the first 2 weeks, make sure their skin is completely dry, and use a gentle cleanser and a good moisturizer," she said at the Hawaii Dermatology Seminar sponsored by Global Academy for Medical Education/Skin Disease Education Foundation. "If they get through those first 2 weeks, they’ll see that the tolerability really improves."

Dr. Stein Gold said she likes the fixed combination of adapalene/benzoyl peroxide gel 0.1%/2.5% because it combines several key elements of cutting-edge acne treatment. Topical retinoids are not mere comedone busters, as formerly thought, but are also effective agents for papules and pustular lesions. While they do not kill Propionibacterium acnes, they down-regulate Toll-like receptor 2, which is produced by the bacterium and induces proinflammatory cytokines. Topical retinoids are a key part of maintenance-of-remission strategies. And adapalene is unique among topical retinoids in that it is inherently stable with benzoyl peroxide (BPO) and is stable in daylight.

BPO is unique in that it has potent antibacterial activity, but never causes P. acnes resistance, even after many years of treatment. BPO is quite effective for inflammatory lesions and moderately effective for comedonal acne lesions, Dr. Stein Gold noted. Also, it is well established that BPO at a concentration of 2.5% is as efficacious as 5% or 10%, and much better tolerated than at the higher concentrations. The molecule size and the use of a vehicle with good penetration into the hair follicle are much more important factors in treatment effectiveness than is the BPO concentration, she added.

In one study of acne patients with antibiotic-resistant P. acnes, including clindamycin-, doxycycline-, erythromycin-, and minocycline-resistant microorganisms, 88% of the antibiotic-resistant P. acnes bacteria were killed after 2 weeks of treatment with adapalene/BPO gel 0.1%/2.5%. After 4 weeks of treatment, 97% of the antibiotic-resistant organisms were dead. That’s testimony to the P. acnes–killing power of BPO, said Dr. Stein Gold.

"There’s a sense among many that with all the newer medications we have for acne, benzoyl peroxide is really your grandfather’s treatment, with no place in today’s modern world. This is totally false. I really feel that benzoyl peroxide should play a central role in all of our acne patients’ treatment regimens, unless of course they’re allergic to it, which occurs in only a small percentage of our patients," she said.

The pooled analysis was funded by Galderma. Dr. Stein Gold is a consultant to Galderma, Stiefel, Medicis, and Warner Chilcott.

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

bjancin@frontlinemedcom.com

WAIKOLOA, HAWAII – The fixed-dose combination of adapalene/benzoyl peroxide gel 0.1%/2.5% typically results in reductions of 40%-50% in inflammatory and 30%-40% in noninflammatory acne lesion counts during the first 4 weeks of therapy.

In a pooled analysis of 14 studies totaling 2,358 acne patients aged 9-61 years, the proportion with an Investigator’s Global Assessment (IGA) of moderate or severe acne dropped from 92% at baseline to 51% at 4 weeks, according to Dr. Linda Stein Gold.

The pooled analysis was carried out to provide physicians and patients with information as to what to realistically expect in the first 4 weeks of therapy. The analysis is particularly timely in light of the Food and Drug Administration’s recent expansion of the indication for adapalene/benzoyl peroxide gel 0.1%/2.5% (Epiduo) to include acne patients as young as 9 years of age, noted Dr. Stein Gold, director of clinical research in the department of dermatology at Henry Ford Hospital, Detroit.

Mild skin irritation was common, especially in the first 2 weeks of use.

"It’s a fiction that retinoids are too harsh for younger patients to use," Dr. Stein Gold said. "I tell all my acne patients, especially the younger ones, no matter what topical retinoid they’re using, to use it every other night for the first 2 weeks, make sure their skin is completely dry, and use a gentle cleanser and a good moisturizer," she said at the Hawaii Dermatology Seminar sponsored by Global Academy for Medical Education/Skin Disease Education Foundation. "If they get through those first 2 weeks, they’ll see that the tolerability really improves."

Dr. Stein Gold said she likes the fixed combination of adapalene/benzoyl peroxide gel 0.1%/2.5% because it combines several key elements of cutting-edge acne treatment. Topical retinoids are not mere comedone busters, as formerly thought, but are also effective agents for papules and pustular lesions. While they do not kill Propionibacterium acnes, they down-regulate Toll-like receptor 2, which is produced by the bacterium and induces proinflammatory cytokines. Topical retinoids are a key part of maintenance-of-remission strategies. And adapalene is unique among topical retinoids in that it is inherently stable with benzoyl peroxide (BPO) and is stable in daylight.

BPO is unique in that it has potent antibacterial activity, but never causes P. acnes resistance, even after many years of treatment. BPO is quite effective for inflammatory lesions and moderately effective for comedonal acne lesions, Dr. Stein Gold noted. Also, it is well established that BPO at a concentration of 2.5% is as efficacious as 5% or 10%, and much better tolerated than at the higher concentrations. The molecule size and the use of a vehicle with good penetration into the hair follicle are much more important factors in treatment effectiveness than is the BPO concentration, she added.

In one study of acne patients with antibiotic-resistant P. acnes, including clindamycin-, doxycycline-, erythromycin-, and minocycline-resistant microorganisms, 88% of the antibiotic-resistant P. acnes bacteria were killed after 2 weeks of treatment with adapalene/BPO gel 0.1%/2.5%. After 4 weeks of treatment, 97% of the antibiotic-resistant organisms were dead. That’s testimony to the P. acnes–killing power of BPO, said Dr. Stein Gold.

"There’s a sense among many that with all the newer medications we have for acne, benzoyl peroxide is really your grandfather’s treatment, with no place in today’s modern world. This is totally false. I really feel that benzoyl peroxide should play a central role in all of our acne patients’ treatment regimens, unless of course they’re allergic to it, which occurs in only a small percentage of our patients," she said.

The pooled analysis was funded by Galderma. Dr. Stein Gold is a consultant to Galderma, Stiefel, Medicis, and Warner Chilcott.

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

bjancin@frontlinemedcom.com

WAIKOLOA, HAWAII – The fixed-dose combination of adapalene/benzoyl peroxide gel 0.1%/2.5% typically results in reductions of 40%-50% in inflammatory and 30%-40% in noninflammatory acne lesion counts during the first 4 weeks of therapy.

In a pooled analysis of 14 studies totaling 2,358 acne patients aged 9-61 years, the proportion with an Investigator’s Global Assessment (IGA) of moderate or severe acne dropped from 92% at baseline to 51% at 4 weeks, according to Dr. Linda Stein Gold.

The pooled analysis was carried out to provide physicians and patients with information as to what to realistically expect in the first 4 weeks of therapy. The analysis is particularly timely in light of the Food and Drug Administration’s recent expansion of the indication for adapalene/benzoyl peroxide gel 0.1%/2.5% (Epiduo) to include acne patients as young as 9 years of age, noted Dr. Stein Gold, director of clinical research in the department of dermatology at Henry Ford Hospital, Detroit.

Mild skin irritation was common, especially in the first 2 weeks of use.

"It’s a fiction that retinoids are too harsh for younger patients to use," Dr. Stein Gold said. "I tell all my acne patients, especially the younger ones, no matter what topical retinoid they’re using, to use it every other night for the first 2 weeks, make sure their skin is completely dry, and use a gentle cleanser and a good moisturizer," she said at the Hawaii Dermatology Seminar sponsored by Global Academy for Medical Education/Skin Disease Education Foundation. "If they get through those first 2 weeks, they’ll see that the tolerability really improves."

Dr. Stein Gold said she likes the fixed combination of adapalene/benzoyl peroxide gel 0.1%/2.5% because it combines several key elements of cutting-edge acne treatment. Topical retinoids are not mere comedone busters, as formerly thought, but are also effective agents for papules and pustular lesions. While they do not kill Propionibacterium acnes, they down-regulate Toll-like receptor 2, which is produced by the bacterium and induces proinflammatory cytokines. Topical retinoids are a key part of maintenance-of-remission strategies. And adapalene is unique among topical retinoids in that it is inherently stable with benzoyl peroxide (BPO) and is stable in daylight.

BPO is unique in that it has potent antibacterial activity, but never causes P. acnes resistance, even after many years of treatment. BPO is quite effective for inflammatory lesions and moderately effective for comedonal acne lesions, Dr. Stein Gold noted. Also, it is well established that BPO at a concentration of 2.5% is as efficacious as 5% or 10%, and much better tolerated than at the higher concentrations. The molecule size and the use of a vehicle with good penetration into the hair follicle are much more important factors in treatment effectiveness than is the BPO concentration, she added.

In one study of acne patients with antibiotic-resistant P. acnes, including clindamycin-, doxycycline-, erythromycin-, and minocycline-resistant microorganisms, 88% of the antibiotic-resistant P. acnes bacteria were killed after 2 weeks of treatment with adapalene/BPO gel 0.1%/2.5%. After 4 weeks of treatment, 97% of the antibiotic-resistant organisms were dead. That’s testimony to the P. acnes–killing power of BPO, said Dr. Stein Gold.

"There’s a sense among many that with all the newer medications we have for acne, benzoyl peroxide is really your grandfather’s treatment, with no place in today’s modern world. This is totally false. I really feel that benzoyl peroxide should play a central role in all of our acne patients’ treatment regimens, unless of course they’re allergic to it, which occurs in only a small percentage of our patients," she said.

The pooled analysis was funded by Galderma. Dr. Stein Gold is a consultant to Galderma, Stiefel, Medicis, and Warner Chilcott.

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

bjancin@frontlinemedcom.com

WAIKOLOA, HAWAII – The fixed-dose combination of adapalene/benzoyl peroxide gel 0.1%/2.5% typically results in reductions of 40%-50% in inflammatory and 30%-40% in noninflammatory acne lesion counts during the first 4 weeks of therapy.

In a pooled analysis of 14 studies totaling 2,358 acne patients aged 9-61 years, the proportion with an Investigator’s Global Assessment (IGA) of moderate or severe acne dropped from 92% at baseline to 51% at 4 weeks, according to Dr. Linda Stein Gold.

The pooled analysis was carried out to provide physicians and patients with information as to what to realistically expect in the first 4 weeks of therapy. The analysis is particularly timely in light of the Food and Drug Administration’s recent expansion of the indication for adapalene/benzoyl peroxide gel 0.1%/2.5% (Epiduo) to include acne patients as young as 9 years of age, noted Dr. Stein Gold, director of clinical research in the department of dermatology at Henry Ford Hospital, Detroit.

Mild skin irritation was common, especially in the first 2 weeks of use.

"It’s a fiction that retinoids are too harsh for younger patients to use," Dr. Stein Gold said. "I tell all my acne patients, especially the younger ones, no matter what topical retinoid they’re using, to use it every other night for the first 2 weeks, make sure their skin is completely dry, and use a gentle cleanser and a good moisturizer," she said at the Hawaii Dermatology Seminar sponsored by Global Academy for Medical Education/Skin Disease Education Foundation. "If they get through those first 2 weeks, they’ll see that the tolerability really improves."

Dr. Stein Gold said she likes the fixed combination of adapalene/benzoyl peroxide gel 0.1%/2.5% because it combines several key elements of cutting-edge acne treatment. Topical retinoids are not mere comedone busters, as formerly thought, but are also effective agents for papules and pustular lesions. While they do not kill Propionibacterium acnes, they down-regulate Toll-like receptor 2, which is produced by the bacterium and induces proinflammatory cytokines. Topical retinoids are a key part of maintenance-of-remission strategies. And adapalene is unique among topical retinoids in that it is inherently stable with benzoyl peroxide (BPO) and is stable in daylight.

BPO is unique in that it has potent antibacterial activity, but never causes P. acnes resistance, even after many years of treatment. BPO is quite effective for inflammatory lesions and moderately effective for comedonal acne lesions, Dr. Stein Gold noted. Also, it is well established that BPO at a concentration of 2.5% is as efficacious as 5% or 10%, and much better tolerated than at the higher concentrations. The molecule size and the use of a vehicle with good penetration into the hair follicle are much more important factors in treatment effectiveness than is the BPO concentration, she added.

In one study of acne patients with antibiotic-resistant P. acnes, including clindamycin-, doxycycline-, erythromycin-, and minocycline-resistant microorganisms, 88% of the antibiotic-resistant P. acnes bacteria were killed after 2 weeks of treatment with adapalene/BPO gel 0.1%/2.5%. After 4 weeks of treatment, 97% of the antibiotic-resistant organisms were dead. That’s testimony to the P. acnes–killing power of BPO, said Dr. Stein Gold.

"There’s a sense among many that with all the newer medications we have for acne, benzoyl peroxide is really your grandfather’s treatment, with no place in today’s modern world. This is totally false. I really feel that benzoyl peroxide should play a central role in all of our acne patients’ treatment regimens, unless of course they’re allergic to it, which occurs in only a small percentage of our patients," she said.

The pooled analysis was funded by Galderma. Dr. Stein Gold is a consultant to Galderma, Stiefel, Medicis, and Warner Chilcott.

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

bjancin@frontlinemedcom.com

WAIKOLOA, HAWAII – Momentum is building – perhaps unstoppably – for creation of a national, population-based melanoma screening program.

"Demand for screening is going up as we speak. The incidence of melanoma is going up dramatically, and it’s really important to understand that this is happening in the absence of formal screening for melanoma. So imagine what would happen if we did screen for melanoma routinely," Dr. Allan C. Halpern observed at the Hawaii Dermatology Seminar sponsored by Global Academy for Medical Education/Skin Disease Education Foundation.

Also, public awareness is increasing dramatically.

"We’ve spent a lot of time as dermatologists educating the public. And there may be as many as a million people walking around the U.S. right now who’ve personally had melanoma. We want to see them in follow-up visits, and their family members want to see us as well," said Dr. Halpern, chief of the dermatology service at Memorial Sloan Kettering Cancer Center in New York.

The current position of the U.S. Preventive Services Task Force (Ann. Intern. Med. 2009;150:194-8), the American Cancer Society, and other influential organizations is that formal guidelines for population-based screening for melanoma are not warranted at this time, because there is no randomized clinical trial evidence of net benefit. That position could change, however, even in the absence of such evidence. For example, the U.S. Preventive Services Task Force strongly supports cervical cancer screening, even though it has never been subjected to a randomized trial. The task force became convinced that cervical cancer screening works on the basis of observational data showing that by the time 80% of women were screened, mortality due to cervical cancer dropped by nearly 50%, Dr. Halpern noted.

The ‘extraordinary’ German example

The ongoing German national experience with melanoma screening may provide a big push for a shift in U.S. health policy in favor of routine screening for melanoma, according to Dr. Halpern.

The German melanoma screening program is one of the most extraordinary stories in dermatology, he said. The program is mainly the work of one determined and persuasive German dermatologist – Dr. Eckhard Breitbart – who has been pushing for melanoma screening in Germany for 45 years. Dr. Breitbart received funding for a pilot study conducted in Germany’s northernmost state, Schleswig-Holstein. The state’s primary care physicians were persuaded to conduct the first-tier screening of all Schleswig-Holstein residents. They received a financial incentive on a per-case basis, provided they first completed an 8-hour training course. The bottom line: After just 2 years of screening, mortality caused by melanoma dropped by 48% over the next 7 years while remaining unchanged in the neighboring states (Cancer 2012;118:5395-402).

Armed with the data, Dr. Breitbart persuaded the German federal government to expand screening nationally. That program began in 2005.

"I don’t think melanoma mortality will come down by 50% across all of Germany, but if the German data show it comes down by 20%-30%, then it’s the cervical cancer story revisited. I think that would be very strong endorsement that screening for melanoma can save lives," Dr. Halpern said.

He injected a cautionary note, however.

"I must warn you; the German experience may not give us definitive answers. It turns out that Eckhard Breitbart was so persuasive when he went to convince the German government to do the screening program that they ‘knew’ for a fact that it was going to work. So they didn’t allocate any money for an assessment of whether it actually works," Dr. Halpern explained.

Also, the study was limited by the German government’s concern about medical records privacy.

"Trying to get the data on who was screened versus who got melanoma and died of it is proving amazingly difficult. There are actually a bunch of melanoma experts here in the states, including Marty Weinstock and Alan Geller, who have been working closely with the German group to try to get some of the data. We’ll just have to wait and see how the German experience plays out," Dr. Halpern continued.

As pressure for routine melanoma screening mounts in the United States, it’s apparent that there is a major supply-and-demand issue involved. The supply of the medical dermatology workforce is shrinking relative to the growing demand, Dr. Halpern said. Going forward, the most promising solution in his view is to train primary care physicians and physician extenders to perform the screening, as is done in Germany. There is an enormous opportunity here for these nondermatologists to harness the emerging automated imaging and molecular sensing technologies for detection of lesion changes and diagnosis of melanoma, he added.

First do no harm

Dr. Halpern offered a note of caution regarding melanoma screening: Although it sounds great in theory because it’s relatively cheap, the lesions are accessible on the surface of the skin, and there is the potential to save many life-years, it’s also imperative to consider the potential harms. Perhaps the biggest of these, Dr. Halpern said, is the psychological damage caused by turning a patient with an indolent, low-risk melanoma or nonmelanoma skin cancer into a cancer patient.

"We have to be really, really careful to look at the harms involved in screening. To my mind, one of the biggest problems of melanoma screening is the psychological harm we do by giving people cancer. I’m especially bothered about the way we do that with patients who develop melanoma in situ or microinvasive disease," he said.

"Believe me, if I had melanoma in situ or microinvasive melanoma, I would want you to find it and take if off for me. What I don’t want you to do is to turn me into a cancer patient. I don’t think that’s in the patient’s best interest whatsoever. We don’t do it intentionally, but as dermatologists we have this tendency to dramatically overplay the importance of these diagnoses," Dr. Halpern said.

Dr. Halpern reported having financial relationships with Scibase, DermTech, Caliber, and Canfield.

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

bjancin@frontlinemedcom.com

WAIKOLOA, HAWAII – Momentum is building – perhaps unstoppably – for creation of a national, population-based melanoma screening program.

"Demand for screening is going up as we speak. The incidence of melanoma is going up dramatically, and it’s really important to understand that this is happening in the absence of formal screening for melanoma. So imagine what would happen if we did screen for melanoma routinely," Dr. Allan C. Halpern observed at the Hawaii Dermatology Seminar sponsored by Global Academy for Medical Education/Skin Disease Education Foundation.

Also, public awareness is increasing dramatically.

"We’ve spent a lot of time as dermatologists educating the public. And there may be as many as a million people walking around the U.S. right now who’ve personally had melanoma. We want to see them in follow-up visits, and their family members want to see us as well," said Dr. Halpern, chief of the dermatology service at Memorial Sloan Kettering Cancer Center in New York.

The current position of the U.S. Preventive Services Task Force (Ann. Intern. Med. 2009;150:194-8), the American Cancer Society, and other influential organizations is that formal guidelines for population-based screening for melanoma are not warranted at this time, because there is no randomized clinical trial evidence of net benefit. That position could change, however, even in the absence of such evidence. For example, the U.S. Preventive Services Task Force strongly supports cervical cancer screening, even though it has never been subjected to a randomized trial. The task force became convinced that cervical cancer screening works on the basis of observational data showing that by the time 80% of women were screened, mortality due to cervical cancer dropped by nearly 50%, Dr. Halpern noted.

The ‘extraordinary’ German example

The ongoing German national experience with melanoma screening may provide a big push for a shift in U.S. health policy in favor of routine screening for melanoma, according to Dr. Halpern.

The German melanoma screening program is one of the most extraordinary stories in dermatology, he said. The program is mainly the work of one determined and persuasive German dermatologist – Dr. Eckhard Breitbart – who has been pushing for melanoma screening in Germany for 45 years. Dr. Breitbart received funding for a pilot study conducted in Germany’s northernmost state, Schleswig-Holstein. The state’s primary care physicians were persuaded to conduct the first-tier screening of all Schleswig-Holstein residents. They received a financial incentive on a per-case basis, provided they first completed an 8-hour training course. The bottom line: After just 2 years of screening, mortality caused by melanoma dropped by 48% over the next 7 years while remaining unchanged in the neighboring states (Cancer 2012;118:5395-402).

Armed with the data, Dr. Breitbart persuaded the German federal government to expand screening nationally. That program began in 2005.

"I don’t think melanoma mortality will come down by 50% across all of Germany, but if the German data show it comes down by 20%-30%, then it’s the cervical cancer story revisited. I think that would be very strong endorsement that screening for melanoma can save lives," Dr. Halpern said.

He injected a cautionary note, however.

"I must warn you; the German experience may not give us definitive answers. It turns out that Eckhard Breitbart was so persuasive when he went to convince the German government to do the screening program that they ‘knew’ for a fact that it was going to work. So they didn’t allocate any money for an assessment of whether it actually works," Dr. Halpern explained.

Also, the study was limited by the German government’s concern about medical records privacy.

"Trying to get the data on who was screened versus who got melanoma and died of it is proving amazingly difficult. There are actually a bunch of melanoma experts here in the states, including Marty Weinstock and Alan Geller, who have been working closely with the German group to try to get some of the data. We’ll just have to wait and see how the German experience plays out," Dr. Halpern continued.

As pressure for routine melanoma screening mounts in the United States, it’s apparent that there is a major supply-and-demand issue involved. The supply of the medical dermatology workforce is shrinking relative to the growing demand, Dr. Halpern said. Going forward, the most promising solution in his view is to train primary care physicians and physician extenders to perform the screening, as is done in Germany. There is an enormous opportunity here for these nondermatologists to harness the emerging automated imaging and molecular sensing technologies for detection of lesion changes and diagnosis of melanoma, he added.

First do no harm

Dr. Halpern offered a note of caution regarding melanoma screening: Although it sounds great in theory because it’s relatively cheap, the lesions are accessible on the surface of the skin, and there is the potential to save many life-years, it’s also imperative to consider the potential harms. Perhaps the biggest of these, Dr. Halpern said, is the psychological damage caused by turning a patient with an indolent, low-risk melanoma or nonmelanoma skin cancer into a cancer patient.

"We have to be really, really careful to look at the harms involved in screening. To my mind, one of the biggest problems of melanoma screening is the psychological harm we do by giving people cancer. I’m especially bothered about the way we do that with patients who develop melanoma in situ or microinvasive disease," he said.

"Believe me, if I had melanoma in situ or microinvasive melanoma, I would want you to find it and take if off for me. What I don’t want you to do is to turn me into a cancer patient. I don’t think that’s in the patient’s best interest whatsoever. We don’t do it intentionally, but as dermatologists we have this tendency to dramatically overplay the importance of these diagnoses," Dr. Halpern said.

Dr. Halpern reported having financial relationships with Scibase, DermTech, Caliber, and Canfield.

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

bjancin@frontlinemedcom.com

WAIKOLOA, HAWAII – Momentum is building – perhaps unstoppably – for creation of a national, population-based melanoma screening program.

"Demand for screening is going up as we speak. The incidence of melanoma is going up dramatically, and it’s really important to understand that this is happening in the absence of formal screening for melanoma. So imagine what would happen if we did screen for melanoma routinely," Dr. Allan C. Halpern observed at the Hawaii Dermatology Seminar sponsored by Global Academy for Medical Education/Skin Disease Education Foundation.

Also, public awareness is increasing dramatically.

"We’ve spent a lot of time as dermatologists educating the public. And there may be as many as a million people walking around the U.S. right now who’ve personally had melanoma. We want to see them in follow-up visits, and their family members want to see us as well," said Dr. Halpern, chief of the dermatology service at Memorial Sloan Kettering Cancer Center in New York.

The current position of the U.S. Preventive Services Task Force (Ann. Intern. Med. 2009;150:194-8), the American Cancer Society, and other influential organizations is that formal guidelines for population-based screening for melanoma are not warranted at this time, because there is no randomized clinical trial evidence of net benefit. That position could change, however, even in the absence of such evidence. For example, the U.S. Preventive Services Task Force strongly supports cervical cancer screening, even though it has never been subjected to a randomized trial. The task force became convinced that cervical cancer screening works on the basis of observational data showing that by the time 80% of women were screened, mortality due to cervical cancer dropped by nearly 50%, Dr. Halpern noted.

The ‘extraordinary’ German example

The ongoing German national experience with melanoma screening may provide a big push for a shift in U.S. health policy in favor of routine screening for melanoma, according to Dr. Halpern.

The German melanoma screening program is one of the most extraordinary stories in dermatology, he said. The program is mainly the work of one determined and persuasive German dermatologist – Dr. Eckhard Breitbart – who has been pushing for melanoma screening in Germany for 45 years. Dr. Breitbart received funding for a pilot study conducted in Germany’s northernmost state, Schleswig-Holstein. The state’s primary care physicians were persuaded to conduct the first-tier screening of all Schleswig-Holstein residents. They received a financial incentive on a per-case basis, provided they first completed an 8-hour training course. The bottom line: After just 2 years of screening, mortality caused by melanoma dropped by 48% over the next 7 years while remaining unchanged in the neighboring states (Cancer 2012;118:5395-402).

Armed with the data, Dr. Breitbart persuaded the German federal government to expand screening nationally. That program began in 2005.

"I don’t think melanoma mortality will come down by 50% across all of Germany, but if the German data show it comes down by 20%-30%, then it’s the cervical cancer story revisited. I think that would be very strong endorsement that screening for melanoma can save lives," Dr. Halpern said.

He injected a cautionary note, however.

"I must warn you; the German experience may not give us definitive answers. It turns out that Eckhard Breitbart was so persuasive when he went to convince the German government to do the screening program that they ‘knew’ for a fact that it was going to work. So they didn’t allocate any money for an assessment of whether it actually works," Dr. Halpern explained.

Also, the study was limited by the German government’s concern about medical records privacy.

"Trying to get the data on who was screened versus who got melanoma and died of it is proving amazingly difficult. There are actually a bunch of melanoma experts here in the states, including Marty Weinstock and Alan Geller, who have been working closely with the German group to try to get some of the data. We’ll just have to wait and see how the German experience plays out," Dr. Halpern continued.

As pressure for routine melanoma screening mounts in the United States, it’s apparent that there is a major supply-and-demand issue involved. The supply of the medical dermatology workforce is shrinking relative to the growing demand, Dr. Halpern said. Going forward, the most promising solution in his view is to train primary care physicians and physician extenders to perform the screening, as is done in Germany. There is an enormous opportunity here for these nondermatologists to harness the emerging automated imaging and molecular sensing technologies for detection of lesion changes and diagnosis of melanoma, he added.

First do no harm

Dr. Halpern offered a note of caution regarding melanoma screening: Although it sounds great in theory because it’s relatively cheap, the lesions are accessible on the surface of the skin, and there is the potential to save many life-years, it’s also imperative to consider the potential harms. Perhaps the biggest of these, Dr. Halpern said, is the psychological damage caused by turning a patient with an indolent, low-risk melanoma or nonmelanoma skin cancer into a cancer patient.

"We have to be really, really careful to look at the harms involved in screening. To my mind, one of the biggest problems of melanoma screening is the psychological harm we do by giving people cancer. I’m especially bothered about the way we do that with patients who develop melanoma in situ or microinvasive disease," he said.

"Believe me, if I had melanoma in situ or microinvasive melanoma, I would want you to find it and take if off for me. What I don’t want you to do is to turn me into a cancer patient. I don’t think that’s in the patient’s best interest whatsoever. We don’t do it intentionally, but as dermatologists we have this tendency to dramatically overplay the importance of these diagnoses," Dr. Halpern said.

Dr. Halpern reported having financial relationships with Scibase, DermTech, Caliber, and Canfield.

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

bjancin@frontlinemedcom.com

WAIKOLOA, HAWAII – Momentum is building – perhaps unstoppably – for creation of a national, population-based melanoma screening program.

"Demand for screening is going up as we speak. The incidence of melanoma is going up dramatically, and it’s really important to understand that this is happening in the absence of formal screening for melanoma. So imagine what would happen if we did screen for melanoma routinely," Dr. Allan C. Halpern observed at the Hawaii Dermatology Seminar sponsored by Global Academy for Medical Education/Skin Disease Education Foundation.

Also, public awareness is increasing dramatically.

"We’ve spent a lot of time as dermatologists educating the public. And there may be as many as a million people walking around the U.S. right now who’ve personally had melanoma. We want to see them in follow-up visits, and their family members want to see us as well," said Dr. Halpern, chief of the dermatology service at Memorial Sloan Kettering Cancer Center in New York.

The current position of the U.S. Preventive Services Task Force (Ann. Intern. Med. 2009;150:194-8), the American Cancer Society, and other influential organizations is that formal guidelines for population-based screening for melanoma are not warranted at this time, because there is no randomized clinical trial evidence of net benefit. That position could change, however, even in the absence of such evidence. For example, the U.S. Preventive Services Task Force strongly supports cervical cancer screening, even though it has never been subjected to a randomized trial. The task force became convinced that cervical cancer screening works on the basis of observational data showing that by the time 80% of women were screened, mortality due to cervical cancer dropped by nearly 50%, Dr. Halpern noted.

The ‘extraordinary’ German example

The ongoing German national experience with melanoma screening may provide a big push for a shift in U.S. health policy in favor of routine screening for melanoma, according to Dr. Halpern.

The German melanoma screening program is one of the most extraordinary stories in dermatology, he said. The program is mainly the work of one determined and persuasive German dermatologist – Dr. Eckhard Breitbart – who has been pushing for melanoma screening in Germany for 45 years. Dr. Breitbart received funding for a pilot study conducted in Germany’s northernmost state, Schleswig-Holstein. The state’s primary care physicians were persuaded to conduct the first-tier screening of all Schleswig-Holstein residents. They received a financial incentive on a per-case basis, provided they first completed an 8-hour training course. The bottom line: After just 2 years of screening, mortality caused by melanoma dropped by 48% over the next 7 years while remaining unchanged in the neighboring states (Cancer 2012;118:5395-402).

Armed with the data, Dr. Breitbart persuaded the German federal government to expand screening nationally. That program began in 2005.

"I don’t think melanoma mortality will come down by 50% across all of Germany, but if the German data show it comes down by 20%-30%, then it’s the cervical cancer story revisited. I think that would be very strong endorsement that screening for melanoma can save lives," Dr. Halpern said.

He injected a cautionary note, however.

"I must warn you; the German experience may not give us definitive answers. It turns out that Eckhard Breitbart was so persuasive when he went to convince the German government to do the screening program that they ‘knew’ for a fact that it was going to work. So they didn’t allocate any money for an assessment of whether it actually works," Dr. Halpern explained.

Also, the study was limited by the German government’s concern about medical records privacy.

"Trying to get the data on who was screened versus who got melanoma and died of it is proving amazingly difficult. There are actually a bunch of melanoma experts here in the states, including Marty Weinstock and Alan Geller, who have been working closely with the German group to try to get some of the data. We’ll just have to wait and see how the German experience plays out," Dr. Halpern continued.

As pressure for routine melanoma screening mounts in the United States, it’s apparent that there is a major supply-and-demand issue involved. The supply of the medical dermatology workforce is shrinking relative to the growing demand, Dr. Halpern said. Going forward, the most promising solution in his view is to train primary care physicians and physician extenders to perform the screening, as is done in Germany. There is an enormous opportunity here for these nondermatologists to harness the emerging automated imaging and molecular sensing technologies for detection of lesion changes and diagnosis of melanoma, he added.

First do no harm

Dr. Halpern offered a note of caution regarding melanoma screening: Although it sounds great in theory because it’s relatively cheap, the lesions are accessible on the surface of the skin, and there is the potential to save many life-years, it’s also imperative to consider the potential harms. Perhaps the biggest of these, Dr. Halpern said, is the psychological damage caused by turning a patient with an indolent, low-risk melanoma or nonmelanoma skin cancer into a cancer patient.

"We have to be really, really careful to look at the harms involved in screening. To my mind, one of the biggest problems of melanoma screening is the psychological harm we do by giving people cancer. I’m especially bothered about the way we do that with patients who develop melanoma in situ or microinvasive disease," he said.

"Believe me, if I had melanoma in situ or microinvasive melanoma, I would want you to find it and take if off for me. What I don’t want you to do is to turn me into a cancer patient. I don’t think that’s in the patient’s best interest whatsoever. We don’t do it intentionally, but as dermatologists we have this tendency to dramatically overplay the importance of these diagnoses," Dr. Halpern said.

Dr. Halpern reported having financial relationships with Scibase, DermTech, Caliber, and Canfield.

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

bjancin@frontlinemedcom.com

WAIKOLOA, HAWAII – Momentum is building – perhaps unstoppably – for creation of a national, population-based melanoma screening program.

"Demand for screening is going up as we speak. The incidence of melanoma is going up dramatically, and it’s really important to understand that this is happening in the absence of formal screening for melanoma. So imagine what would happen if we did screen for melanoma routinely," Dr. Allan C. Halpern observed at the Hawaii Dermatology Seminar sponsored by Global Academy for Medical Education/Skin Disease Education Foundation.

Also, public awareness is increasing dramatically.

"We’ve spent a lot of time as dermatologists educating the public. And there may be as many as a million people walking around the U.S. right now who’ve personally had melanoma. We want to see them in follow-up visits, and their family members want to see us as well," said Dr. Halpern, chief of the dermatology service at Memorial Sloan Kettering Cancer Center in New York.

The current position of the U.S. Preventive Services Task Force (Ann. Intern. Med. 2009;150:194-8), the American Cancer Society, and other influential organizations is that formal guidelines for population-based screening for melanoma are not warranted at this time, because there is no randomized clinical trial evidence of net benefit. That position could change, however, even in the absence of such evidence. For example, the U.S. Preventive Services Task Force strongly supports cervical cancer screening, even though it has never been subjected to a randomized trial. The task force became convinced that cervical cancer screening works on the basis of observational data showing that by the time 80% of women were screened, mortality due to cervical cancer dropped by nearly 50%, Dr. Halpern noted.

The ‘extraordinary’ German example

The ongoing German national experience with melanoma screening may provide a big push for a shift in U.S. health policy in favor of routine screening for melanoma, according to Dr. Halpern.

The German melanoma screening program is one of the most extraordinary stories in dermatology, he said. The program is mainly the work of one determined and persuasive German dermatologist – Dr. Eckhard Breitbart – who has been pushing for melanoma screening in Germany for 45 years. Dr. Breitbart received funding for a pilot study conducted in Germany’s northernmost state, Schleswig-Holstein. The state’s primary care physicians were persuaded to conduct the first-tier screening of all Schleswig-Holstein residents. They received a financial incentive on a per-case basis, provided they first completed an 8-hour training course. The bottom line: After just 2 years of screening, mortality caused by melanoma dropped by 48% over the next 7 years while remaining unchanged in the neighboring states (Cancer 2012;118:5395-402).

Armed with the data, Dr. Breitbart persuaded the German federal government to expand screening nationally. That program began in 2005.

"I don’t think melanoma mortality will come down by 50% across all of Germany, but if the German data show it comes down by 20%-30%, then it’s the cervical cancer story revisited. I think that would be very strong endorsement that screening for melanoma can save lives," Dr. Halpern said.

He injected a cautionary note, however.

"I must warn you; the German experience may not give us definitive answers. It turns out that Eckhard Breitbart was so persuasive when he went to convince the German government to do the screening program that they ‘knew’ for a fact that it was going to work. So they didn’t allocate any money for an assessment of whether it actually works," Dr. Halpern explained.

Also, the study was limited by the German government’s concern about medical records privacy.

"Trying to get the data on who was screened versus who got melanoma and died of it is proving amazingly difficult. There are actually a bunch of melanoma experts here in the states, including Marty Weinstock and Alan Geller, who have been working closely with the German group to try to get some of the data. We’ll just have to wait and see how the German experience plays out," Dr. Halpern continued.

As pressure for routine melanoma screening mounts in the United States, it’s apparent that there is a major supply-and-demand issue involved. The supply of the medical dermatology workforce is shrinking relative to the growing demand, Dr. Halpern said. Going forward, the most promising solution in his view is to train primary care physicians and physician extenders to perform the screening, as is done in Germany. There is an enormous opportunity here for these nondermatologists to harness the emerging automated imaging and molecular sensing technologies for detection of lesion changes and diagnosis of melanoma, he added.

First do no harm

Dr. Halpern offered a note of caution regarding melanoma screening: Although it sounds great in theory because it’s relatively cheap, the lesions are accessible on the surface of the skin, and there is the potential to save many life-years, it’s also imperative to consider the potential harms. Perhaps the biggest of these, Dr. Halpern said, is the psychological damage caused by turning a patient with an indolent, low-risk melanoma or nonmelanoma skin cancer into a cancer patient.

"We have to be really, really careful to look at the harms involved in screening. To my mind, one of the biggest problems of melanoma screening is the psychological harm we do by giving people cancer. I’m especially bothered about the way we do that with patients who develop melanoma in situ or microinvasive disease," he said.

"Believe me, if I had melanoma in situ or microinvasive melanoma, I would want you to find it and take if off for me. What I don’t want you to do is to turn me into a cancer patient. I don’t think that’s in the patient’s best interest whatsoever. We don’t do it intentionally, but as dermatologists we have this tendency to dramatically overplay the importance of these diagnoses," Dr. Halpern said.

Dr. Halpern reported having financial relationships with Scibase, DermTech, Caliber, and Canfield.

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

bjancin@frontlinemedcom.com

WAIKOLOA, HAWAII – Momentum is building – perhaps unstoppably – for creation of a national, population-based melanoma screening program.

"Demand for screening is going up as we speak. The incidence of melanoma is going up dramatically, and it’s really important to understand that this is happening in the absence of formal screening for melanoma. So imagine what would happen if we did screen for melanoma routinely," Dr. Allan C. Halpern observed at the Hawaii Dermatology Seminar sponsored by Global Academy for Medical Education/Skin Disease Education Foundation.

Also, public awareness is increasing dramatically.

"We’ve spent a lot of time as dermatologists educating the public. And there may be as many as a million people walking around the U.S. right now who’ve personally had melanoma. We want to see them in follow-up visits, and their family members want to see us as well," said Dr. Halpern, chief of the dermatology service at Memorial Sloan Kettering Cancer Center in New York.

The current position of the U.S. Preventive Services Task Force (Ann. Intern. Med. 2009;150:194-8), the American Cancer Society, and other influential organizations is that formal guidelines for population-based screening for melanoma are not warranted at this time, because there is no randomized clinical trial evidence of net benefit. That position could change, however, even in the absence of such evidence. For example, the U.S. Preventive Services Task Force strongly supports cervical cancer screening, even though it has never been subjected to a randomized trial. The task force became convinced that cervical cancer screening works on the basis of observational data showing that by the time 80% of women were screened, mortality due to cervical cancer dropped by nearly 50%, Dr. Halpern noted.

The ‘extraordinary’ German example

The ongoing German national experience with melanoma screening may provide a big push for a shift in U.S. health policy in favor of routine screening for melanoma, according to Dr. Halpern.

The German melanoma screening program is one of the most extraordinary stories in dermatology, he said. The program is mainly the work of one determined and persuasive German dermatologist – Dr. Eckhard Breitbart – who has been pushing for melanoma screening in Germany for 45 years. Dr. Breitbart received funding for a pilot study conducted in Germany’s northernmost state, Schleswig-Holstein. The state’s primary care physicians were persuaded to conduct the first-tier screening of all Schleswig-Holstein residents. They received a financial incentive on a per-case basis, provided they first completed an 8-hour training course. The bottom line: After just 2 years of screening, mortality caused by melanoma dropped by 48% over the next 7 years while remaining unchanged in the neighboring states (Cancer 2012;118:5395-402).

Armed with the data, Dr. Breitbart persuaded the German federal government to expand screening nationally. That program began in 2005.

"I don’t think melanoma mortality will come down by 50% across all of Germany, but if the German data show it comes down by 20%-30%, then it’s the cervical cancer story revisited. I think that would be very strong endorsement that screening for melanoma can save lives," Dr. Halpern said.

He injected a cautionary note, however.

"I must warn you; the German experience may not give us definitive answers. It turns out that Eckhard Breitbart was so persuasive when he went to convince the German government to do the screening program that they ‘knew’ for a fact that it was going to work. So they didn’t allocate any money for an assessment of whether it actually works," Dr. Halpern explained.

Also, the study was limited by the German government’s concern about medical records privacy.

"Trying to get the data on who was screened versus who got melanoma and died of it is proving amazingly difficult. There are actually a bunch of melanoma experts here in the states, including Marty Weinstock and Alan Geller, who have been working closely with the German group to try to get some of the data. We’ll just have to wait and see how the German experience plays out," Dr. Halpern continued.

As pressure for routine melanoma screening mounts in the United States, it’s apparent that there is a major supply-and-demand issue involved. The supply of the medical dermatology workforce is shrinking relative to the growing demand, Dr. Halpern said. Going forward, the most promising solution in his view is to train primary care physicians and physician extenders to perform the screening, as is done in Germany. There is an enormous opportunity here for these nondermatologists to harness the emerging automated imaging and molecular sensing technologies for detection of lesion changes and diagnosis of melanoma, he added.

First do no harm

Dr. Halpern offered a note of caution regarding melanoma screening: Although it sounds great in theory because it’s relatively cheap, the lesions are accessible on the surface of the skin, and there is the potential to save many life-years, it’s also imperative to consider the potential harms. Perhaps the biggest of these, Dr. Halpern said, is the psychological damage caused by turning a patient with an indolent, low-risk melanoma or nonmelanoma skin cancer into a cancer patient.

"We have to be really, really careful to look at the harms involved in screening. To my mind, one of the biggest problems of melanoma screening is the psychological harm we do by giving people cancer. I’m especially bothered about the way we do that with patients who develop melanoma in situ or microinvasive disease," he said.

"Believe me, if I had melanoma in situ or microinvasive melanoma, I would want you to find it and take if off for me. What I don’t want you to do is to turn me into a cancer patient. I don’t think that’s in the patient’s best interest whatsoever. We don’t do it intentionally, but as dermatologists we have this tendency to dramatically overplay the importance of these diagnoses," Dr. Halpern said.

Dr. Halpern reported having financial relationships with Scibase, DermTech, Caliber, and Canfield.

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

bjancin@frontlinemedcom.com

WAIKOLOA, HAWAII – Guttate psoriasis in children warrants more aggressive monitoring and treatment in an effort to head off more severe disease later, according to Dr. Wynnis L. Tom.

Pediatric psoriasis presenting initially as guttate disease is more likely to progress to severe psoriasis prior to adulthood than if the initial presentation took the form of plaque psoriasis, according to data from a multicenter U.S. study of the clinical manifestations of pediatric psoriasis.

The cross-sectional study included 181 children aged 5-17 years with plaque psoriasis, and the results highlighted important differences between childhood-onset and adult-onset disease, Dr. Tom said at the Hawaii Dermatology Seminar sponsored by Global Academy for Medical Education/Skin Disease Education Foundation.

About 40% of cases of pediatric psoriasis that presented initially as guttate psoriasis progressed to chronic disease. That was not a higher proportion than in children whose initial disease was plaque psoriasis, said Dr. Tom of the University of California, San Diego, and Rady Children’s Hospital. However, 36% of youths with severe psoriasis had a history of disease onset with guttate morphology compared with 22% of those with mild disease, she said.

The peak severity of psoriasis was defined historically as either mild or severe based upon body surface area involvement and Physician Global Assessment.

Overall, 79% of study participants had a history of scalp psoriasis and 39% had a history of nail involvement. However, these disease expressions were unrelated to psoriasis severity.

Boys were three times more likely than girls to have had nail involvement, but 60% less likely to have a history of scalp involvement. These sex-related differences probably reflect koebnerization, Dr. Tom said.

Approximately 5% of the patients had psoriasis restricted to their face alone. Among those with body involvement, the face was included in nearly half of cases.

Session chair Dr. Lawrence F. Eichenfield praised this study (Pediatr. Dermatol. 2013;30:424-8), on which Dr. Tom was a coauthor, as one of the top articles in the field of pediatric dermatology published within the past year. Although various studies indicate that 27%-45% of all cases of psoriasis begin in childhood, the clinical aspects of pediatric psoriasis haven’t been well characterized until now, said Dr. Eichenfield, professor of clinical pediatrics and medicine and chief of pediatric and adolescent dermatology at the University of California, San Diego.

Dr. Eichenfield also singled out Dr. Tom as coauthor of yet another of his top picks of recently published studies on the topic of pediatric psoriasis. This cross-sectional study included 409 psoriasis patients aged 5-17 years in nine countries. The prevalence of excess adiposity as defined by a body mass index at the 85th percentile or greater was 38% among the psoriatic children compared with 21% in matched controls. The likelihood of obesity as defined by a BMI in the 95th percentile or higher was 4.9-fold greater in children with severe psoriasis than in controls, and 3.6-fold greater in those with mild psoriasis compared than in controls. Among U.S. patients, the psoriasis/obesity association was magnified such that American children with severe and mild psoriasis were respectively 7.6-fold and 4.7-fold more likely to be obese than controls (JAMA Dermatol. 2013;149:166-76).

Central adiposity – an element of metabolic syndrome associated with increased cardiovascular risk in adults – was present as defined by waist circumference greater than the 90th percentile in 21% of youths with severe psoriasis, 14% with mild disease, and 9% of controls. In U.S. participants, these figures ballooned to 31%, 21%, and 12%, respectively.

Dr. Tom cited evidence from yet another study in which she was a coinvestigator suggesting that obesity may be a risk factor for pediatric psoriasis, rather than the other way around. In this three-center study, nearly all of a group of pediatric psoriasis patients were overweight or obese for at least 2 years prior to their psoriasis onset.

Current National Psoriasis Foundation guidelines recommend initiating cardiovascular risk factor screening "as early as age 20." Dr. Tom is among those seeking to revise the guidelines to extend screening to pediatric psoriasis patients. She said she now recommends consideration of cardiovascular screening in overweight and obese pediatric psoriasis patients – including monitoring of blood pressure, lipids, fasting blood glucose, and liver enzymes – along with hard-hitting guidance on dietary modifications, weight loss, and the importance of exercise.

"Ongoing studies are assessing the need for screening labs for nonoverweight children with psoriasis. Hopefully this will be sorted out soon as a group in our field. We’re hoping for updated guidelines," she said.

Dr. Tom disclosed serving as a financially uncompensated investigator for Amgen and Anacor.

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

bjancin@frontlinemedcom.com

WAIKOLOA, HAWAII – Guttate psoriasis in children warrants more aggressive monitoring and treatment in an effort to head off more severe disease later, according to Dr. Wynnis L. Tom.

Pediatric psoriasis presenting initially as guttate disease is more likely to progress to severe psoriasis prior to adulthood than if the initial presentation took the form of plaque psoriasis, according to data from a multicenter U.S. study of the clinical manifestations of pediatric psoriasis.

The cross-sectional study included 181 children aged 5-17 years with plaque psoriasis, and the results highlighted important differences between childhood-onset and adult-onset disease, Dr. Tom said at the Hawaii Dermatology Seminar sponsored by Global Academy for Medical Education/Skin Disease Education Foundation.

About 40% of cases of pediatric psoriasis that presented initially as guttate psoriasis progressed to chronic disease. That was not a higher proportion than in children whose initial disease was plaque psoriasis, said Dr. Tom of the University of California, San Diego, and Rady Children’s Hospital. However, 36% of youths with severe psoriasis had a history of disease onset with guttate morphology compared with 22% of those with mild disease, she said.

The peak severity of psoriasis was defined historically as either mild or severe based upon body surface area involvement and Physician Global Assessment.

Overall, 79% of study participants had a history of scalp psoriasis and 39% had a history of nail involvement. However, these disease expressions were unrelated to psoriasis severity.

Boys were three times more likely than girls to have had nail involvement, but 60% less likely to have a history of scalp involvement. These sex-related differences probably reflect koebnerization, Dr. Tom said.

Approximately 5% of the patients had psoriasis restricted to their face alone. Among those with body involvement, the face was included in nearly half of cases.

Session chair Dr. Lawrence F. Eichenfield praised this study (Pediatr. Dermatol. 2013;30:424-8), on which Dr. Tom was a coauthor, as one of the top articles in the field of pediatric dermatology published within the past year. Although various studies indicate that 27%-45% of all cases of psoriasis begin in childhood, the clinical aspects of pediatric psoriasis haven’t been well characterized until now, said Dr. Eichenfield, professor of clinical pediatrics and medicine and chief of pediatric and adolescent dermatology at the University of California, San Diego.

Dr. Eichenfield also singled out Dr. Tom as coauthor of yet another of his top picks of recently published studies on the topic of pediatric psoriasis. This cross-sectional study included 409 psoriasis patients aged 5-17 years in nine countries. The prevalence of excess adiposity as defined by a body mass index at the 85th percentile or greater was 38% among the psoriatic children compared with 21% in matched controls. The likelihood of obesity as defined by a BMI in the 95th percentile or higher was 4.9-fold greater in children with severe psoriasis than in controls, and 3.6-fold greater in those with mild psoriasis compared than in controls. Among U.S. patients, the psoriasis/obesity association was magnified such that American children with severe and mild psoriasis were respectively 7.6-fold and 4.7-fold more likely to be obese than controls (JAMA Dermatol. 2013;149:166-76).

Central adiposity – an element of metabolic syndrome associated with increased cardiovascular risk in adults – was present as defined by waist circumference greater than the 90th percentile in 21% of youths with severe psoriasis, 14% with mild disease, and 9% of controls. In U.S. participants, these figures ballooned to 31%, 21%, and 12%, respectively.

Dr. Tom cited evidence from yet another study in which she was a coinvestigator suggesting that obesity may be a risk factor for pediatric psoriasis, rather than the other way around. In this three-center study, nearly all of a group of pediatric psoriasis patients were overweight or obese for at least 2 years prior to their psoriasis onset.

Current National Psoriasis Foundation guidelines recommend initiating cardiovascular risk factor screening "as early as age 20." Dr. Tom is among those seeking to revise the guidelines to extend screening to pediatric psoriasis patients. She said she now recommends consideration of cardiovascular screening in overweight and obese pediatric psoriasis patients – including monitoring of blood pressure, lipids, fasting blood glucose, and liver enzymes – along with hard-hitting guidance on dietary modifications, weight loss, and the importance of exercise.

"Ongoing studies are assessing the need for screening labs for nonoverweight children with psoriasis. Hopefully this will be sorted out soon as a group in our field. We’re hoping for updated guidelines," she said.

Dr. Tom disclosed serving as a financially uncompensated investigator for Amgen and Anacor.

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

bjancin@frontlinemedcom.com

WAIKOLOA, HAWAII – Guttate psoriasis in children warrants more aggressive monitoring and treatment in an effort to head off more severe disease later, according to Dr. Wynnis L. Tom.

Pediatric psoriasis presenting initially as guttate disease is more likely to progress to severe psoriasis prior to adulthood than if the initial presentation took the form of plaque psoriasis, according to data from a multicenter U.S. study of the clinical manifestations of pediatric psoriasis.

The cross-sectional study included 181 children aged 5-17 years with plaque psoriasis, and the results highlighted important differences between childhood-onset and adult-onset disease, Dr. Tom said at the Hawaii Dermatology Seminar sponsored by Global Academy for Medical Education/Skin Disease Education Foundation.

About 40% of cases of pediatric psoriasis that presented initially as guttate psoriasis progressed to chronic disease. That was not a higher proportion than in children whose initial disease was plaque psoriasis, said Dr. Tom of the University of California, San Diego, and Rady Children’s Hospital. However, 36% of youths with severe psoriasis had a history of disease onset with guttate morphology compared with 22% of those with mild disease, she said.

The peak severity of psoriasis was defined historically as either mild or severe based upon body surface area involvement and Physician Global Assessment.

Overall, 79% of study participants had a history of scalp psoriasis and 39% had a history of nail involvement. However, these disease expressions were unrelated to psoriasis severity.

Boys were three times more likely than girls to have had nail involvement, but 60% less likely to have a history of scalp involvement. These sex-related differences probably reflect koebnerization, Dr. Tom said.

Approximately 5% of the patients had psoriasis restricted to their face alone. Among those with body involvement, the face was included in nearly half of cases.

Session chair Dr. Lawrence F. Eichenfield praised this study (Pediatr. Dermatol. 2013;30:424-8), on which Dr. Tom was a coauthor, as one of the top articles in the field of pediatric dermatology published within the past year. Although various studies indicate that 27%-45% of all cases of psoriasis begin in childhood, the clinical aspects of pediatric psoriasis haven’t been well characterized until now, said Dr. Eichenfield, professor of clinical pediatrics and medicine and chief of pediatric and adolescent dermatology at the University of California, San Diego.

Dr. Eichenfield also singled out Dr. Tom as coauthor of yet another of his top picks of recently published studies on the topic of pediatric psoriasis. This cross-sectional study included 409 psoriasis patients aged 5-17 years in nine countries. The prevalence of excess adiposity as defined by a body mass index at the 85th percentile or greater was 38% among the psoriatic children compared with 21% in matched controls. The likelihood of obesity as defined by a BMI in the 95th percentile or higher was 4.9-fold greater in children with severe psoriasis than in controls, and 3.6-fold greater in those with mild psoriasis compared than in controls. Among U.S. patients, the psoriasis/obesity association was magnified such that American children with severe and mild psoriasis were respectively 7.6-fold and 4.7-fold more likely to be obese than controls (JAMA Dermatol. 2013;149:166-76).

Central adiposity – an element of metabolic syndrome associated with increased cardiovascular risk in adults – was present as defined by waist circumference greater than the 90th percentile in 21% of youths with severe psoriasis, 14% with mild disease, and 9% of controls. In U.S. participants, these figures ballooned to 31%, 21%, and 12%, respectively.

Dr. Tom cited evidence from yet another study in which she was a coinvestigator suggesting that obesity may be a risk factor for pediatric psoriasis, rather than the other way around. In this three-center study, nearly all of a group of pediatric psoriasis patients were overweight or obese for at least 2 years prior to their psoriasis onset.

Current National Psoriasis Foundation guidelines recommend initiating cardiovascular risk factor screening "as early as age 20." Dr. Tom is among those seeking to revise the guidelines to extend screening to pediatric psoriasis patients. She said she now recommends consideration of cardiovascular screening in overweight and obese pediatric psoriasis patients – including monitoring of blood pressure, lipids, fasting blood glucose, and liver enzymes – along with hard-hitting guidance on dietary modifications, weight loss, and the importance of exercise.

"Ongoing studies are assessing the need for screening labs for nonoverweight children with psoriasis. Hopefully this will be sorted out soon as a group in our field. We’re hoping for updated guidelines," she said.

Dr. Tom disclosed serving as a financially uncompensated investigator for Amgen and Anacor.

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

bjancin@frontlinemedcom.com