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VIDEO: The DecisionDx-Melanoma test can predict metastasis of sentinel node-negative melanomas
DENVER – A 134-patient study of patients with stage I, II, or III cutaneous melanoma found that the DecisionDx-Melanoma test was useful for identifying a high-risk group of patients with negative sentinel lymph node biopsy results.
In a video interview, Dr. Pedram Gerami of the department of dermatology and director of melanoma research at the Northwestern University Skin Cancer Institute, Chicago, explains the best uses for the test and its patient management advantages.
The video associated with this article is no longer available on this site. Please view all of our videos on the MDedge YouTube channel
On Twitter @naseemmiller
DENVER – A 134-patient study of patients with stage I, II, or III cutaneous melanoma found that the DecisionDx-Melanoma test was useful for identifying a high-risk group of patients with negative sentinel lymph node biopsy results.
In a video interview, Dr. Pedram Gerami of the department of dermatology and director of melanoma research at the Northwestern University Skin Cancer Institute, Chicago, explains the best uses for the test and its patient management advantages.
The video associated with this article is no longer available on this site. Please view all of our videos on the MDedge YouTube channel
On Twitter @naseemmiller
DENVER – A 134-patient study of patients with stage I, II, or III cutaneous melanoma found that the DecisionDx-Melanoma test was useful for identifying a high-risk group of patients with negative sentinel lymph node biopsy results.
In a video interview, Dr. Pedram Gerami of the department of dermatology and director of melanoma research at the Northwestern University Skin Cancer Institute, Chicago, explains the best uses for the test and its patient management advantages.
The video associated with this article is no longer available on this site. Please view all of our videos on the MDedge YouTube channel
On Twitter @naseemmiller
AT THE AAD ANNUAL MEETING
VIDEO: AAD encourages members to be on top of ACA
DENVER – Dermatologists must get involved with their local medical societies and national groups, and they should learn more about the Affordable Care Act’s insurance exchanges and the accountable care organizations to be fully aware of how health reform is going to affect them.
That’s the advice from leaders at the American Academy of Dermatology annual meeting, who shared their perspectives on how dermatologists can best prepare themselves for the practice and market shifts that reform will bring. The academy itself has a comprehensive resource center on its website.
In a video interview, Dr. Marta J. VanBeek, chair of AAD Association’s Council on Government Affairs, Health Policy, and Practice, and director of dermatologic surgery at the University of Iowa, Iowa City, along with Dr. Kathryn Schwarzenberger, professor and Rex Amonette Endowed Chair of Excellence in Dermatology at the University of Tennessee, Memphis, spoke about why it’s important for dermatologists to be fully aware and educated about the Affordable Care Act.
The video associated with this article is no longer available on this site. Please view all of our videos on the MDedge YouTube channel
On Twitter @naseemmiller
DENVER – Dermatologists must get involved with their local medical societies and national groups, and they should learn more about the Affordable Care Act’s insurance exchanges and the accountable care organizations to be fully aware of how health reform is going to affect them.
That’s the advice from leaders at the American Academy of Dermatology annual meeting, who shared their perspectives on how dermatologists can best prepare themselves for the practice and market shifts that reform will bring. The academy itself has a comprehensive resource center on its website.
In a video interview, Dr. Marta J. VanBeek, chair of AAD Association’s Council on Government Affairs, Health Policy, and Practice, and director of dermatologic surgery at the University of Iowa, Iowa City, along with Dr. Kathryn Schwarzenberger, professor and Rex Amonette Endowed Chair of Excellence in Dermatology at the University of Tennessee, Memphis, spoke about why it’s important for dermatologists to be fully aware and educated about the Affordable Care Act.
The video associated with this article is no longer available on this site. Please view all of our videos on the MDedge YouTube channel
On Twitter @naseemmiller
DENVER – Dermatologists must get involved with their local medical societies and national groups, and they should learn more about the Affordable Care Act’s insurance exchanges and the accountable care organizations to be fully aware of how health reform is going to affect them.
That’s the advice from leaders at the American Academy of Dermatology annual meeting, who shared their perspectives on how dermatologists can best prepare themselves for the practice and market shifts that reform will bring. The academy itself has a comprehensive resource center on its website.
In a video interview, Dr. Marta J. VanBeek, chair of AAD Association’s Council on Government Affairs, Health Policy, and Practice, and director of dermatologic surgery at the University of Iowa, Iowa City, along with Dr. Kathryn Schwarzenberger, professor and Rex Amonette Endowed Chair of Excellence in Dermatology at the University of Tennessee, Memphis, spoke about why it’s important for dermatologists to be fully aware and educated about the Affordable Care Act.
The video associated with this article is no longer available on this site. Please view all of our videos on the MDedge YouTube channel
On Twitter @naseemmiller
At THE AAD ANNUAL MEETING
Gene test predicts metastasis of sentinel node-negative melanomas
DENVER – A gene expression profile test was an independent predictor of metastasis of primary cutaneous melanomas in patients with negative sentinel lymph node biopsies.
The DecisionDx-Melanoma test is useful for identifying a high-risk group of patients with negative sentinel lymph node biopsy results, said Dr. Pedram Gerami of the department of dermatology and director of melanoma research at the Northwestern University, Chicago, Skin Cancer Institute. The test "is an independent predictor of metastasis and death, and significantly improves upon sentinel lymph node biopsy for staging melanoma patients."
The results of the DecisionDx-Melanoma test, a noninvasive 31-gene expression profile (GEP) test, were compared with the results of sentinel lymph node biopsy (SLNB) in 134 patients who had stage I, II, or III cutaneous melanoma and underwent a documented sentinel lymph node procedure. Of the 134 patients, 28 had positive sentinel lymph nodes and 91 had positive (class 2, high risk) GEP results.
Metastases developed over a subsequent 5-year period in 18 of the 28 patients with positive SLNB and in 62 of the 91 patients with positive GEP results. Metastases developed in 51 of the 106 patients with negative SLNB and in 7 of 43 patients with negative (class 1, low risk) GEP results.
While the positive predictive value of the two tests were comparable, the ability of GEP to predict negative outcomes was significantly better than that of SLNB (P less than .0001), Dr. Gerami reported at the annual meeting of the American Academy of Dermatology.
The rate of 5-year metastasis-free survival (MFS) was 55% for 106 patients with negative SLNB, compared to 37% for 28 patients with positive SLNB (P = .003). The GEP test results showed improved prognostic accuracy in these same patients with an MFS of 87% for the 43 patients with negative GEP (class 1, low risk) results and of 31% for the 91 patients with positive GEP (class 2, high risk) results (P less than .0001).
Differences in overall survival (OS) paralleled the MFS rates, with SLNB-negative patients having a 5-year OS of 67% and SLNB-positive patients having a 5-year OS of 55% (P = .024). OS for negative GEP (class 1, low risk) patients was 92% and for positive GEP (high risk, class 2) was 49% (P less than .0001).
Use of the GEP test also was analyzed in combination with SLNB status. As expected, the 20% of patients (n = 27) who had high-risk results for both tests (GEP class 2 and SLNB-positive findings) had lower survival rates (MFS, 34%; OS, 53%). Similarly, the 31% of patients (n = 42) who had low-risk results for both tests (GEP class 1 and SLNB-negative findings) had higher survival rates (MFS, 82%; OS, 92%).
Importantly, the MFS was 31% and the OS was 49% at 5 years in the 64 patients who had SLNB-negative results but class 2 GEP test results, Dr. Gerami said. Cox multivariate analysis comparing the GEP test to SLNB showed the GEP test to be the only independent and highly significant prognostic factor in this analysis (P less than .000003).
Dr. Gerami has been a consultant to Castle Biosciences. The DecisionDx-Melanoma test is a product of Castle Biosciences, the sponsor of the study. More information about the test can be found at www.skinmelanoma.com.
On Twitter @maryjodales
DENVER – A gene expression profile test was an independent predictor of metastasis of primary cutaneous melanomas in patients with negative sentinel lymph node biopsies.
The DecisionDx-Melanoma test is useful for identifying a high-risk group of patients with negative sentinel lymph node biopsy results, said Dr. Pedram Gerami of the department of dermatology and director of melanoma research at the Northwestern University, Chicago, Skin Cancer Institute. The test "is an independent predictor of metastasis and death, and significantly improves upon sentinel lymph node biopsy for staging melanoma patients."
The results of the DecisionDx-Melanoma test, a noninvasive 31-gene expression profile (GEP) test, were compared with the results of sentinel lymph node biopsy (SLNB) in 134 patients who had stage I, II, or III cutaneous melanoma and underwent a documented sentinel lymph node procedure. Of the 134 patients, 28 had positive sentinel lymph nodes and 91 had positive (class 2, high risk) GEP results.
Metastases developed over a subsequent 5-year period in 18 of the 28 patients with positive SLNB and in 62 of the 91 patients with positive GEP results. Metastases developed in 51 of the 106 patients with negative SLNB and in 7 of 43 patients with negative (class 1, low risk) GEP results.
While the positive predictive value of the two tests were comparable, the ability of GEP to predict negative outcomes was significantly better than that of SLNB (P less than .0001), Dr. Gerami reported at the annual meeting of the American Academy of Dermatology.
The rate of 5-year metastasis-free survival (MFS) was 55% for 106 patients with negative SLNB, compared to 37% for 28 patients with positive SLNB (P = .003). The GEP test results showed improved prognostic accuracy in these same patients with an MFS of 87% for the 43 patients with negative GEP (class 1, low risk) results and of 31% for the 91 patients with positive GEP (class 2, high risk) results (P less than .0001).
Differences in overall survival (OS) paralleled the MFS rates, with SLNB-negative patients having a 5-year OS of 67% and SLNB-positive patients having a 5-year OS of 55% (P = .024). OS for negative GEP (class 1, low risk) patients was 92% and for positive GEP (high risk, class 2) was 49% (P less than .0001).
Use of the GEP test also was analyzed in combination with SLNB status. As expected, the 20% of patients (n = 27) who had high-risk results for both tests (GEP class 2 and SLNB-positive findings) had lower survival rates (MFS, 34%; OS, 53%). Similarly, the 31% of patients (n = 42) who had low-risk results for both tests (GEP class 1 and SLNB-negative findings) had higher survival rates (MFS, 82%; OS, 92%).
Importantly, the MFS was 31% and the OS was 49% at 5 years in the 64 patients who had SLNB-negative results but class 2 GEP test results, Dr. Gerami said. Cox multivariate analysis comparing the GEP test to SLNB showed the GEP test to be the only independent and highly significant prognostic factor in this analysis (P less than .000003).
Dr. Gerami has been a consultant to Castle Biosciences. The DecisionDx-Melanoma test is a product of Castle Biosciences, the sponsor of the study. More information about the test can be found at www.skinmelanoma.com.
On Twitter @maryjodales
DENVER – A gene expression profile test was an independent predictor of metastasis of primary cutaneous melanomas in patients with negative sentinel lymph node biopsies.
The DecisionDx-Melanoma test is useful for identifying a high-risk group of patients with negative sentinel lymph node biopsy results, said Dr. Pedram Gerami of the department of dermatology and director of melanoma research at the Northwestern University, Chicago, Skin Cancer Institute. The test "is an independent predictor of metastasis and death, and significantly improves upon sentinel lymph node biopsy for staging melanoma patients."
The results of the DecisionDx-Melanoma test, a noninvasive 31-gene expression profile (GEP) test, were compared with the results of sentinel lymph node biopsy (SLNB) in 134 patients who had stage I, II, or III cutaneous melanoma and underwent a documented sentinel lymph node procedure. Of the 134 patients, 28 had positive sentinel lymph nodes and 91 had positive (class 2, high risk) GEP results.
Metastases developed over a subsequent 5-year period in 18 of the 28 patients with positive SLNB and in 62 of the 91 patients with positive GEP results. Metastases developed in 51 of the 106 patients with negative SLNB and in 7 of 43 patients with negative (class 1, low risk) GEP results.
While the positive predictive value of the two tests were comparable, the ability of GEP to predict negative outcomes was significantly better than that of SLNB (P less than .0001), Dr. Gerami reported at the annual meeting of the American Academy of Dermatology.
The rate of 5-year metastasis-free survival (MFS) was 55% for 106 patients with negative SLNB, compared to 37% for 28 patients with positive SLNB (P = .003). The GEP test results showed improved prognostic accuracy in these same patients with an MFS of 87% for the 43 patients with negative GEP (class 1, low risk) results and of 31% for the 91 patients with positive GEP (class 2, high risk) results (P less than .0001).
Differences in overall survival (OS) paralleled the MFS rates, with SLNB-negative patients having a 5-year OS of 67% and SLNB-positive patients having a 5-year OS of 55% (P = .024). OS for negative GEP (class 1, low risk) patients was 92% and for positive GEP (high risk, class 2) was 49% (P less than .0001).
Use of the GEP test also was analyzed in combination with SLNB status. As expected, the 20% of patients (n = 27) who had high-risk results for both tests (GEP class 2 and SLNB-positive findings) had lower survival rates (MFS, 34%; OS, 53%). Similarly, the 31% of patients (n = 42) who had low-risk results for both tests (GEP class 1 and SLNB-negative findings) had higher survival rates (MFS, 82%; OS, 92%).
Importantly, the MFS was 31% and the OS was 49% at 5 years in the 64 patients who had SLNB-negative results but class 2 GEP test results, Dr. Gerami said. Cox multivariate analysis comparing the GEP test to SLNB showed the GEP test to be the only independent and highly significant prognostic factor in this analysis (P less than .000003).
Dr. Gerami has been a consultant to Castle Biosciences. The DecisionDx-Melanoma test is a product of Castle Biosciences, the sponsor of the study. More information about the test can be found at www.skinmelanoma.com.
On Twitter @maryjodales
AT THE AAD ANNUAL MEETING
Major finding: Metastasis-free survival was 31% and overall survival was 49% at 5 years in the 64 patients who had negative sentinel node lymph biopsy results and high-risk, class 2 gene expression profile test results.
Data source: A study of 134 patients who had stage I, II, or III cutaneous melanoma and underwent a documented sentinel lymph node procedure.
Disclosures: Dr. Gerami has been a consultant to Castle Biosciences. The DecisionDx-Melanoma test is a product of Castle Biosciences, the study sponsor.
Don’t discount the role of patient satisfaction in successful outcomes
DENVER – In the opinion of Dr. Steven R. Feldman, key elements of the therapeutic process include making the right diagnosis, prescribing the right treatment, and getting patients to use prescribed medication.
"These three elements can be considered technical aspects of care, but patient satisfaction is also critical in its own right, because it determines the outcomes of care," Dr. Feldman said at the annual meeting of the American Academy of Dermatology.
Getting patients to use prescribed medication, for example, "is critical to treatment success and depends on the quality of the interaction between patients and clinicians," he said. "You want that interaction to be good. Not only is it good for business and reduces malpractice risk, it is essential for getting patients well."
In dermatology, medication compliance among patients with acne and psoriasis is notoriously poor, but physicians can make an impact by focusing on trust, motivation, and understanding, said Dr. Feldman, professor of dermatology, pathology, and public health sciences at Wake Forest University, Winston-Salem, N.C. "These factors are just as important as the right diagnosis and the right treatment, and they’re largely under our control," he said.
Dr. Feldman, who founded the online patient satisfaction survey service www.DrScore.com, listed seven traits that patients identify in outstanding physicians: access, communication (including listening, forming partnership with the patient, and giving information); a personality/demeanor that projects empathy; medical care (including technical competence, timely diagnoses, treatment, and thoroughness); follow-up (including test results and referrals); facilities; and office/staff coordination.
"Traits patients don’t like include poor access, poor communications, poor follow-up, and a lack of interpersonal skills," said Dr. Feldman, who also is a member of the AAD Outcome Study Workgroup. "In good medical practice you want to make the right diagnosis, prescribe the right treatment, communicate and follow up, and project the appearance of empathy. Think about how you are going to pay attention to this particular patient just before you enter the room."
He noted that, when it comes to patient satisfaction, projecting the appearance of empathy is actually more important than being empathetic.
"I assume all doctors care deeply about their patients," Dr. Feldman said. "But if the patient doesn’t realize the doctor cares, then the patient will not be satisfied, won’t be trusting, and is at risk of poor adherence and poor treatment outcome."
Patient satisfaction studies suggest that patients care more about having a caring/friendly physician than the physician’s age, gender, or office wait time.
"It’s not just the doctor’s behavior that’s important," he continued. "Attend to warmth and fuzziness in your entire practice as though it matters, because it does. Our beliefs are strongly influenced by context."
Simple ways to foster positive physician-patient interaction include using images to communicate risks in perspective, providing written instruction for care, and giving your cell phone number to patients. That gesture alone "is a powerful statement of how much you care about the patient," Dr. Feldman said. "Leave your patients with the clear realization that you care about them."
Counseling patients about the potential side effects of medications is also important, "because fear of [side effects] can reduce compliance," he said. "For acne patients on spironolactone, you might say something like, ‘This drug is a diuretic. In addition to its effects on your acne, you may also notice some weight loss.’ For patients with scalp psoriasis, you might tell them that their recommended treatment may sting. The stinging is a sign that it’s working."
Dr. Feldman disclosed that, in addition to founding DrScore.com and the adherence company Causa Research, he has received grants and/or research funding from numerous pharmaceutical companies.
DENVER – In the opinion of Dr. Steven R. Feldman, key elements of the therapeutic process include making the right diagnosis, prescribing the right treatment, and getting patients to use prescribed medication.
"These three elements can be considered technical aspects of care, but patient satisfaction is also critical in its own right, because it determines the outcomes of care," Dr. Feldman said at the annual meeting of the American Academy of Dermatology.
Getting patients to use prescribed medication, for example, "is critical to treatment success and depends on the quality of the interaction between patients and clinicians," he said. "You want that interaction to be good. Not only is it good for business and reduces malpractice risk, it is essential for getting patients well."
In dermatology, medication compliance among patients with acne and psoriasis is notoriously poor, but physicians can make an impact by focusing on trust, motivation, and understanding, said Dr. Feldman, professor of dermatology, pathology, and public health sciences at Wake Forest University, Winston-Salem, N.C. "These factors are just as important as the right diagnosis and the right treatment, and they’re largely under our control," he said.
Dr. Feldman, who founded the online patient satisfaction survey service www.DrScore.com, listed seven traits that patients identify in outstanding physicians: access, communication (including listening, forming partnership with the patient, and giving information); a personality/demeanor that projects empathy; medical care (including technical competence, timely diagnoses, treatment, and thoroughness); follow-up (including test results and referrals); facilities; and office/staff coordination.
"Traits patients don’t like include poor access, poor communications, poor follow-up, and a lack of interpersonal skills," said Dr. Feldman, who also is a member of the AAD Outcome Study Workgroup. "In good medical practice you want to make the right diagnosis, prescribe the right treatment, communicate and follow up, and project the appearance of empathy. Think about how you are going to pay attention to this particular patient just before you enter the room."
He noted that, when it comes to patient satisfaction, projecting the appearance of empathy is actually more important than being empathetic.
"I assume all doctors care deeply about their patients," Dr. Feldman said. "But if the patient doesn’t realize the doctor cares, then the patient will not be satisfied, won’t be trusting, and is at risk of poor adherence and poor treatment outcome."
Patient satisfaction studies suggest that patients care more about having a caring/friendly physician than the physician’s age, gender, or office wait time.
"It’s not just the doctor’s behavior that’s important," he continued. "Attend to warmth and fuzziness in your entire practice as though it matters, because it does. Our beliefs are strongly influenced by context."
Simple ways to foster positive physician-patient interaction include using images to communicate risks in perspective, providing written instruction for care, and giving your cell phone number to patients. That gesture alone "is a powerful statement of how much you care about the patient," Dr. Feldman said. "Leave your patients with the clear realization that you care about them."
Counseling patients about the potential side effects of medications is also important, "because fear of [side effects] can reduce compliance," he said. "For acne patients on spironolactone, you might say something like, ‘This drug is a diuretic. In addition to its effects on your acne, you may also notice some weight loss.’ For patients with scalp psoriasis, you might tell them that their recommended treatment may sting. The stinging is a sign that it’s working."
Dr. Feldman disclosed that, in addition to founding DrScore.com and the adherence company Causa Research, he has received grants and/or research funding from numerous pharmaceutical companies.
DENVER – In the opinion of Dr. Steven R. Feldman, key elements of the therapeutic process include making the right diagnosis, prescribing the right treatment, and getting patients to use prescribed medication.
"These three elements can be considered technical aspects of care, but patient satisfaction is also critical in its own right, because it determines the outcomes of care," Dr. Feldman said at the annual meeting of the American Academy of Dermatology.
Getting patients to use prescribed medication, for example, "is critical to treatment success and depends on the quality of the interaction between patients and clinicians," he said. "You want that interaction to be good. Not only is it good for business and reduces malpractice risk, it is essential for getting patients well."
In dermatology, medication compliance among patients with acne and psoriasis is notoriously poor, but physicians can make an impact by focusing on trust, motivation, and understanding, said Dr. Feldman, professor of dermatology, pathology, and public health sciences at Wake Forest University, Winston-Salem, N.C. "These factors are just as important as the right diagnosis and the right treatment, and they’re largely under our control," he said.
Dr. Feldman, who founded the online patient satisfaction survey service www.DrScore.com, listed seven traits that patients identify in outstanding physicians: access, communication (including listening, forming partnership with the patient, and giving information); a personality/demeanor that projects empathy; medical care (including technical competence, timely diagnoses, treatment, and thoroughness); follow-up (including test results and referrals); facilities; and office/staff coordination.
"Traits patients don’t like include poor access, poor communications, poor follow-up, and a lack of interpersonal skills," said Dr. Feldman, who also is a member of the AAD Outcome Study Workgroup. "In good medical practice you want to make the right diagnosis, prescribe the right treatment, communicate and follow up, and project the appearance of empathy. Think about how you are going to pay attention to this particular patient just before you enter the room."
He noted that, when it comes to patient satisfaction, projecting the appearance of empathy is actually more important than being empathetic.
"I assume all doctors care deeply about their patients," Dr. Feldman said. "But if the patient doesn’t realize the doctor cares, then the patient will not be satisfied, won’t be trusting, and is at risk of poor adherence and poor treatment outcome."
Patient satisfaction studies suggest that patients care more about having a caring/friendly physician than the physician’s age, gender, or office wait time.
"It’s not just the doctor’s behavior that’s important," he continued. "Attend to warmth and fuzziness in your entire practice as though it matters, because it does. Our beliefs are strongly influenced by context."
Simple ways to foster positive physician-patient interaction include using images to communicate risks in perspective, providing written instruction for care, and giving your cell phone number to patients. That gesture alone "is a powerful statement of how much you care about the patient," Dr. Feldman said. "Leave your patients with the clear realization that you care about them."
Counseling patients about the potential side effects of medications is also important, "because fear of [side effects] can reduce compliance," he said. "For acne patients on spironolactone, you might say something like, ‘This drug is a diuretic. In addition to its effects on your acne, you may also notice some weight loss.’ For patients with scalp psoriasis, you might tell them that their recommended treatment may sting. The stinging is a sign that it’s working."
Dr. Feldman disclosed that, in addition to founding DrScore.com and the adherence company Causa Research, he has received grants and/or research funding from numerous pharmaceutical companies.
AT THE AAD ANNUAL MEETING
Investigational antibody improves itching, quality of life in severe atopic dermatitis
DENVER – The investigational drug REGN668, a monoclonal antibody that modulates interleukins 4 and 13, significantly improved overall quality of life and pruritus in patients with severe, longstanding atopic dermatitis.
Improvements for patients in the REGN668 (dupilumab) group were obvious in the first week of treatment and achieved statistical significance by week 2 of the placebo-controlled trial, Dr. Thomas Luger said at the annual meeting of the American Academy of Dermatology.
The drug probably works in two ways, said Dr. Luger of the University of Munster, Germany.
"It can be explained by its down-regulation of the immune mediators IL 4 and IL 13, but another issue is also important. IL4 has been shown to impair barrier function by down-modulating filaggrin expression," he noted.
The 12-week, multicenter trial randomized 109 patients to weekly injections of 300 mg dupilumab or placebo. The primary endpoint was the percent change in the Eczema Area and Severity Index (EASI) scale. Secondary endpoints were change from baseline in measures of pruritus and the proportion of patients who reached the EASI 50-75 level.
On the primary endpoint of change in EASI, dupilumab was associated with significantly greater improvement than placebo. By the end of week 1, the EASI had already dropped 10%, Dr. Luger said. By week 2, it had decreased 40% from baseline compared with placebo, and the improvement continued each week, then plateaued at about 7 weeks, with a mean decrease of 74%.
Changes in pruritus and overall quality of life were secondary endpoints for 65 patients who completed the quality of life portion. The validated survey was only available in French and German, and some of the study participants did not speak those languages.
The secondary exploratory endpoint was the change in baseline on the Quality of Life Index for Atopic Dermatitis, a 25-question survey, and its association with clinical outcomes. A higher score indicates worse quality of life; a two- to three-point change is considered clinically significant.
All of the patients were white; mean age was about 40 years and the mean disease duration was 28 years. The mean baseline EASI score was 27, indicating moderate severity. Scores on measures of pruritus indicated severe itching. The mean QoLIAD score was 12, with 25 being the worst.
The quality of life score followed the same pattern as the primary endpoint, Dr. Luger said. The average quality of life score had improved by approximately 25% after 1 week and by approximately 45% after 2 weeks. The score continued to drop, plateauing at an 80% decrease by week 7 and maintaining that level through the end of the treatment period. Almost all treated patients (91%) achieved at least at 50% reduction in symptoms, with 69% achieving at least a 75% reduction.
Pruritus was measured in two QoLIAD subscales: the numeric rating scale (NRS) and the 5-D itch scale. Itching began to improve early and continued to do so until it reached a maximum reduction of 65% in week 8 on the NRS. By week 12, the mean reduction in itching was 60%.
The 5-D scale followed a similar pattern, with early improvement that reached a maximum 50% reduction by week 8. By week 12, the mean reduction from baseline was 45%.
The overall QoLIAD score reflected these changes, improving by a mean of 6.5 points by week 12. In the placebo group, this score remained virtually unchanged. QoLIAD improvements strongly correlated with clinical improvements, Dr. Luger added.
Dupilumab was well tolerated overall. The most frequent adverse events were nasopharyngitis, headache, and conjunctivitis. Skin infections occurred in significantly fewer patients taking the drug, compared with placebo (5.5% vs. 24%). There were no infection-related serious adverse events or eczema herpeticum occurrences in the dupilumab group.
Sanofi and Regeneron, which are jointly developing dupilumab, sponsored the study. Dr. Luger is a consultant for numerous pharmaceutical companies but not for Sanofi or Regeneron.
On Twitter @alz_gal
DENVER – The investigational drug REGN668, a monoclonal antibody that modulates interleukins 4 and 13, significantly improved overall quality of life and pruritus in patients with severe, longstanding atopic dermatitis.
Improvements for patients in the REGN668 (dupilumab) group were obvious in the first week of treatment and achieved statistical significance by week 2 of the placebo-controlled trial, Dr. Thomas Luger said at the annual meeting of the American Academy of Dermatology.
The drug probably works in two ways, said Dr. Luger of the University of Munster, Germany.
"It can be explained by its down-regulation of the immune mediators IL 4 and IL 13, but another issue is also important. IL4 has been shown to impair barrier function by down-modulating filaggrin expression," he noted.
The 12-week, multicenter trial randomized 109 patients to weekly injections of 300 mg dupilumab or placebo. The primary endpoint was the percent change in the Eczema Area and Severity Index (EASI) scale. Secondary endpoints were change from baseline in measures of pruritus and the proportion of patients who reached the EASI 50-75 level.
On the primary endpoint of change in EASI, dupilumab was associated with significantly greater improvement than placebo. By the end of week 1, the EASI had already dropped 10%, Dr. Luger said. By week 2, it had decreased 40% from baseline compared with placebo, and the improvement continued each week, then plateaued at about 7 weeks, with a mean decrease of 74%.
Changes in pruritus and overall quality of life were secondary endpoints for 65 patients who completed the quality of life portion. The validated survey was only available in French and German, and some of the study participants did not speak those languages.
The secondary exploratory endpoint was the change in baseline on the Quality of Life Index for Atopic Dermatitis, a 25-question survey, and its association with clinical outcomes. A higher score indicates worse quality of life; a two- to three-point change is considered clinically significant.
All of the patients were white; mean age was about 40 years and the mean disease duration was 28 years. The mean baseline EASI score was 27, indicating moderate severity. Scores on measures of pruritus indicated severe itching. The mean QoLIAD score was 12, with 25 being the worst.
The quality of life score followed the same pattern as the primary endpoint, Dr. Luger said. The average quality of life score had improved by approximately 25% after 1 week and by approximately 45% after 2 weeks. The score continued to drop, plateauing at an 80% decrease by week 7 and maintaining that level through the end of the treatment period. Almost all treated patients (91%) achieved at least at 50% reduction in symptoms, with 69% achieving at least a 75% reduction.
Pruritus was measured in two QoLIAD subscales: the numeric rating scale (NRS) and the 5-D itch scale. Itching began to improve early and continued to do so until it reached a maximum reduction of 65% in week 8 on the NRS. By week 12, the mean reduction in itching was 60%.
The 5-D scale followed a similar pattern, with early improvement that reached a maximum 50% reduction by week 8. By week 12, the mean reduction from baseline was 45%.
The overall QoLIAD score reflected these changes, improving by a mean of 6.5 points by week 12. In the placebo group, this score remained virtually unchanged. QoLIAD improvements strongly correlated with clinical improvements, Dr. Luger added.
Dupilumab was well tolerated overall. The most frequent adverse events were nasopharyngitis, headache, and conjunctivitis. Skin infections occurred in significantly fewer patients taking the drug, compared with placebo (5.5% vs. 24%). There were no infection-related serious adverse events or eczema herpeticum occurrences in the dupilumab group.
Sanofi and Regeneron, which are jointly developing dupilumab, sponsored the study. Dr. Luger is a consultant for numerous pharmaceutical companies but not for Sanofi or Regeneron.
On Twitter @alz_gal
DENVER – The investigational drug REGN668, a monoclonal antibody that modulates interleukins 4 and 13, significantly improved overall quality of life and pruritus in patients with severe, longstanding atopic dermatitis.
Improvements for patients in the REGN668 (dupilumab) group were obvious in the first week of treatment and achieved statistical significance by week 2 of the placebo-controlled trial, Dr. Thomas Luger said at the annual meeting of the American Academy of Dermatology.
The drug probably works in two ways, said Dr. Luger of the University of Munster, Germany.
"It can be explained by its down-regulation of the immune mediators IL 4 and IL 13, but another issue is also important. IL4 has been shown to impair barrier function by down-modulating filaggrin expression," he noted.
The 12-week, multicenter trial randomized 109 patients to weekly injections of 300 mg dupilumab or placebo. The primary endpoint was the percent change in the Eczema Area and Severity Index (EASI) scale. Secondary endpoints were change from baseline in measures of pruritus and the proportion of patients who reached the EASI 50-75 level.
On the primary endpoint of change in EASI, dupilumab was associated with significantly greater improvement than placebo. By the end of week 1, the EASI had already dropped 10%, Dr. Luger said. By week 2, it had decreased 40% from baseline compared with placebo, and the improvement continued each week, then plateaued at about 7 weeks, with a mean decrease of 74%.
Changes in pruritus and overall quality of life were secondary endpoints for 65 patients who completed the quality of life portion. The validated survey was only available in French and German, and some of the study participants did not speak those languages.
The secondary exploratory endpoint was the change in baseline on the Quality of Life Index for Atopic Dermatitis, a 25-question survey, and its association with clinical outcomes. A higher score indicates worse quality of life; a two- to three-point change is considered clinically significant.
All of the patients were white; mean age was about 40 years and the mean disease duration was 28 years. The mean baseline EASI score was 27, indicating moderate severity. Scores on measures of pruritus indicated severe itching. The mean QoLIAD score was 12, with 25 being the worst.
The quality of life score followed the same pattern as the primary endpoint, Dr. Luger said. The average quality of life score had improved by approximately 25% after 1 week and by approximately 45% after 2 weeks. The score continued to drop, plateauing at an 80% decrease by week 7 and maintaining that level through the end of the treatment period. Almost all treated patients (91%) achieved at least at 50% reduction in symptoms, with 69% achieving at least a 75% reduction.
Pruritus was measured in two QoLIAD subscales: the numeric rating scale (NRS) and the 5-D itch scale. Itching began to improve early and continued to do so until it reached a maximum reduction of 65% in week 8 on the NRS. By week 12, the mean reduction in itching was 60%.
The 5-D scale followed a similar pattern, with early improvement that reached a maximum 50% reduction by week 8. By week 12, the mean reduction from baseline was 45%.
The overall QoLIAD score reflected these changes, improving by a mean of 6.5 points by week 12. In the placebo group, this score remained virtually unchanged. QoLIAD improvements strongly correlated with clinical improvements, Dr. Luger added.
Dupilumab was well tolerated overall. The most frequent adverse events were nasopharyngitis, headache, and conjunctivitis. Skin infections occurred in significantly fewer patients taking the drug, compared with placebo (5.5% vs. 24%). There were no infection-related serious adverse events or eczema herpeticum occurrences in the dupilumab group.
Sanofi and Regeneron, which are jointly developing dupilumab, sponsored the study. Dr. Luger is a consultant for numerous pharmaceutical companies but not for Sanofi or Regeneron.
On Twitter @alz_gal
AT THE AAD ANNUAL MEETING
Major finding: Compared with placebo, the investigational monoclonal antibody dupilumab reduced pruritus by up to 65% and improved quality of life scores by 80%.
Data source: The placebo-controlled study involved 109 patients, 65 of whom completed quality of life measures.
Disclosures: Sanofi and Regeneron, which are jointly developing dupilumab, sponsored the study. Dr. Luger is a consultant for numerous pharmaceutical companies, but not for Sanofi or Regeneron.
Blood test predicts Merkel cell carcinoma metastases
DENVER – A newly-available test based on the results of a simple blood draw has proved useful for detecting early recurrences of Merkel cell carcinomas in those patients who produce antibodies to the Merkel polyomavirus oncoprotein at initial diagnosis.
Known as AMERK, the test can be used at diagnosis to determine which patients have the oncoprotein antibodies and performed at routine followups as an indicator of recurrence in asymptomatic, antibody-positive patients.
The test already has been shown to alert clinicians to the presence of surgically manageable metastases that would have otherwise gone undetected until symptoms prompted a tomographic scan, Dr. Astrid Blom reported at the annual meeting of the American Academy of Dermatology. She presented two cases of surgically operable metastatic Merkel cell tumors, one metastatic to the kidney and the other to the pancreas; both were detected via increasing titers of oncoprotein antibodies in otherwise asymptomatic patients.
Nearly 40% of Merkel cell carcinomas recur. Performing a predictive blood test at routine followups can be a reassuring measure in those patients with negative findings. It also can be an early indicator of metastasis in otherwise asymptomatic patients who made oncoprotein antibodies at diagnosis and were successfully treated for Merkel call carcinoma, she said.
Merkel cell polyomavirus drives about 80% of the approximately 2,000 Merkel cell carcinomas that are diagnosed each year. About half of affected patients produce oncoprotein antibodies to the polyomavirus, which are detectable at diagnosis. The AMERK test is useful only for followup of those patients with oncoprotein antibodies. Patients who lack initially detectable levels of oncoprotein antibodies at diagnosis do not later produce antibodies should their disease recur, reported Dr. Blom of the University of Washington, Seattle, where the test was developed and is performed.
The clinical utility of AMERK, a 75-step assay that takes nearly 2 days to perform, was verified using 1,342 samples from 104 controls and 519 patients from around the world, with data correlating to 3,018 status updates. The data analysis was limited to the 217 patients with adequate follow-up data.
A simple blood draw was collected and sent for analysis at the University of Washington, Seattle. Oncoprotein antibodies were detected in 52% of 217 patients with incident cases of Merkel cell carcinoma and in 2% of 530 control subjects. The antibody titers in controls were barely detectable, however, unlike the levels seen in the patients. The sensitivity of the test was 82%, and the specificity was 98%; the negative predictive value was 99%, and the positive predictive value was 78%.
Levels decrease by 90% or more over the course of the year after successful surgical treatment of Merkel cell carcinomas. When the cancers recur, at least a 10-fold increase in oncoprotein antibody titers are noted.
Support for the development of the AMERK test came from the National Institutes of Health, the National Cancer Institute, and the American Cancer Society and from private donors and patients.
RESOURCES:
Information about the test is available online at http://www.merkelcell.org/sero/
A video that discusses the antibody test can be viewed here.
Dr. Kelly Paulsen, et.al. published the scientific paper that first described the test (Cancer Res. 70(21): 8388-97).
How to order the Merkel virus serology test
Physicians and staff based outside of the University of Washington system should contact their local laboratory where the patient will have their blood sample collected to initiate the process.
The local laboratory "send out test coordinator" should contact the UW Reference Laboratory Services Call Center at 206-685-6066. UW Reference Laboratory Services will set up an account for the ordering physician or clinic; collect the required billing and reporting information; and provide requirements for sample collection, processing and shipping from the local laboratory. Once this one-time administrative process is complete, patient samples can be collected routinely from that facility for the Merkel antibody test (name of test is "AMERK").
On Twitter @maryjodales
DENVER – A newly-available test based on the results of a simple blood draw has proved useful for detecting early recurrences of Merkel cell carcinomas in those patients who produce antibodies to the Merkel polyomavirus oncoprotein at initial diagnosis.
Known as AMERK, the test can be used at diagnosis to determine which patients have the oncoprotein antibodies and performed at routine followups as an indicator of recurrence in asymptomatic, antibody-positive patients.
The test already has been shown to alert clinicians to the presence of surgically manageable metastases that would have otherwise gone undetected until symptoms prompted a tomographic scan, Dr. Astrid Blom reported at the annual meeting of the American Academy of Dermatology. She presented two cases of surgically operable metastatic Merkel cell tumors, one metastatic to the kidney and the other to the pancreas; both were detected via increasing titers of oncoprotein antibodies in otherwise asymptomatic patients.
Nearly 40% of Merkel cell carcinomas recur. Performing a predictive blood test at routine followups can be a reassuring measure in those patients with negative findings. It also can be an early indicator of metastasis in otherwise asymptomatic patients who made oncoprotein antibodies at diagnosis and were successfully treated for Merkel call carcinoma, she said.
Merkel cell polyomavirus drives about 80% of the approximately 2,000 Merkel cell carcinomas that are diagnosed each year. About half of affected patients produce oncoprotein antibodies to the polyomavirus, which are detectable at diagnosis. The AMERK test is useful only for followup of those patients with oncoprotein antibodies. Patients who lack initially detectable levels of oncoprotein antibodies at diagnosis do not later produce antibodies should their disease recur, reported Dr. Blom of the University of Washington, Seattle, where the test was developed and is performed.
The clinical utility of AMERK, a 75-step assay that takes nearly 2 days to perform, was verified using 1,342 samples from 104 controls and 519 patients from around the world, with data correlating to 3,018 status updates. The data analysis was limited to the 217 patients with adequate follow-up data.
A simple blood draw was collected and sent for analysis at the University of Washington, Seattle. Oncoprotein antibodies were detected in 52% of 217 patients with incident cases of Merkel cell carcinoma and in 2% of 530 control subjects. The antibody titers in controls were barely detectable, however, unlike the levels seen in the patients. The sensitivity of the test was 82%, and the specificity was 98%; the negative predictive value was 99%, and the positive predictive value was 78%.
Levels decrease by 90% or more over the course of the year after successful surgical treatment of Merkel cell carcinomas. When the cancers recur, at least a 10-fold increase in oncoprotein antibody titers are noted.
Support for the development of the AMERK test came from the National Institutes of Health, the National Cancer Institute, and the American Cancer Society and from private donors and patients.
RESOURCES:
Information about the test is available online at http://www.merkelcell.org/sero/
A video that discusses the antibody test can be viewed here.
Dr. Kelly Paulsen, et.al. published the scientific paper that first described the test (Cancer Res. 70(21): 8388-97).
How to order the Merkel virus serology test
Physicians and staff based outside of the University of Washington system should contact their local laboratory where the patient will have their blood sample collected to initiate the process.
The local laboratory "send out test coordinator" should contact the UW Reference Laboratory Services Call Center at 206-685-6066. UW Reference Laboratory Services will set up an account for the ordering physician or clinic; collect the required billing and reporting information; and provide requirements for sample collection, processing and shipping from the local laboratory. Once this one-time administrative process is complete, patient samples can be collected routinely from that facility for the Merkel antibody test (name of test is "AMERK").
On Twitter @maryjodales
DENVER – A newly-available test based on the results of a simple blood draw has proved useful for detecting early recurrences of Merkel cell carcinomas in those patients who produce antibodies to the Merkel polyomavirus oncoprotein at initial diagnosis.
Known as AMERK, the test can be used at diagnosis to determine which patients have the oncoprotein antibodies and performed at routine followups as an indicator of recurrence in asymptomatic, antibody-positive patients.
The test already has been shown to alert clinicians to the presence of surgically manageable metastases that would have otherwise gone undetected until symptoms prompted a tomographic scan, Dr. Astrid Blom reported at the annual meeting of the American Academy of Dermatology. She presented two cases of surgically operable metastatic Merkel cell tumors, one metastatic to the kidney and the other to the pancreas; both were detected via increasing titers of oncoprotein antibodies in otherwise asymptomatic patients.
Nearly 40% of Merkel cell carcinomas recur. Performing a predictive blood test at routine followups can be a reassuring measure in those patients with negative findings. It also can be an early indicator of metastasis in otherwise asymptomatic patients who made oncoprotein antibodies at diagnosis and were successfully treated for Merkel call carcinoma, she said.
Merkel cell polyomavirus drives about 80% of the approximately 2,000 Merkel cell carcinomas that are diagnosed each year. About half of affected patients produce oncoprotein antibodies to the polyomavirus, which are detectable at diagnosis. The AMERK test is useful only for followup of those patients with oncoprotein antibodies. Patients who lack initially detectable levels of oncoprotein antibodies at diagnosis do not later produce antibodies should their disease recur, reported Dr. Blom of the University of Washington, Seattle, where the test was developed and is performed.
The clinical utility of AMERK, a 75-step assay that takes nearly 2 days to perform, was verified using 1,342 samples from 104 controls and 519 patients from around the world, with data correlating to 3,018 status updates. The data analysis was limited to the 217 patients with adequate follow-up data.
A simple blood draw was collected and sent for analysis at the University of Washington, Seattle. Oncoprotein antibodies were detected in 52% of 217 patients with incident cases of Merkel cell carcinoma and in 2% of 530 control subjects. The antibody titers in controls were barely detectable, however, unlike the levels seen in the patients. The sensitivity of the test was 82%, and the specificity was 98%; the negative predictive value was 99%, and the positive predictive value was 78%.
Levels decrease by 90% or more over the course of the year after successful surgical treatment of Merkel cell carcinomas. When the cancers recur, at least a 10-fold increase in oncoprotein antibody titers are noted.
Support for the development of the AMERK test came from the National Institutes of Health, the National Cancer Institute, and the American Cancer Society and from private donors and patients.
RESOURCES:
Information about the test is available online at http://www.merkelcell.org/sero/
A video that discusses the antibody test can be viewed here.
Dr. Kelly Paulsen, et.al. published the scientific paper that first described the test (Cancer Res. 70(21): 8388-97).
How to order the Merkel virus serology test
Physicians and staff based outside of the University of Washington system should contact their local laboratory where the patient will have their blood sample collected to initiate the process.
The local laboratory "send out test coordinator" should contact the UW Reference Laboratory Services Call Center at 206-685-6066. UW Reference Laboratory Services will set up an account for the ordering physician or clinic; collect the required billing and reporting information; and provide requirements for sample collection, processing and shipping from the local laboratory. Once this one-time administrative process is complete, patient samples can be collected routinely from that facility for the Merkel antibody test (name of test is "AMERK").
On Twitter @maryjodales
AT THE AAD ANNUAL MEETING
Major finding: Two cases of surgically operable, metastatic Merkel cell tumors, one metastatic to the kidney and the other to the pancreas, were detected via increasing serum titers of oncoprotein antibodies as part of the followup of otherwise asymptomatic patients.
Data source: Followup study of the 52% of 217 patients who had incident cases of Merkel cell carcinoma and had positive titers for oncoprotein antibodies.
Disclosures: Support for the development of the AMERK test came from the National Institutes of Health, the National Cancer Institute, the American Cancer Society, and from private donors and patients.
Novel agent for papulopustular rosacea found safe, effective in phase III trials
DENVER – Ivermectin 1% cream applied once daily was effective and safe in treating patients with moderate to severe papulopustular rosacea, based on data from a pair of phase III studies.
Ivermectin 1% cream, a novel agent being developed by Galderma Laboratories, is of interest to rosacea researchers because it possesses unique anti-inflammatory and anti-parasitic properties, Dr. Linda Stein Gold said at the annual meeting of the American Academy of Dermatology.
Dr. Stein Gold of the department of dermatology at Henry Ford Medical Center, Detroit, explained that Demodex folliculorum, which is typically found on the human face, may trigger an immune response in rosacea patients. Ivermectin 1% is anti-parasitic against Demodex, providing an "innovative treatment" option in this patient population, she said. The investigational agent has not yet been approved by the Food and Drug Administration.
Dr. Stein Gold and her associates set out to assess the efficacy and safety of 1% ivermectin cream vs. a control vehicle cream in patients with moderate to severe papulopustular rosacea. The design included two identical, double-blind, parallel group, 12-week studies.
In both studies, a total of 910 patients were randomized 2:1 to receive 1% ivermectin cream or a control cream once daily. There were two co-primary endpoints: the percentage of patients who achieved a "clear" or "almost clear" score on the Investigator’s Global Assessment (IGA) scale at week 12, and the change in inflammatory lesion counts from baseline to week 12. The secondary efficacy endpoint assessment was the percentage change in inflammatory lesion count from baseline to week 12. The researchers also assessed safety endpoints by examining adverse events.
The mean age of patients was 50 years, 96% were white, and 67% were women. Patients had about 30 lesions each; 76-82% were classified as having moderate rosacea based on IGA score, and the rest had severe disease. More than 90% of patients in each arm completed the study through week 12.
At week 12 in both studies, a significantly higher percentage of patients in the treatment group achieved treatment success compared with those in the control group (38-40% vs. 12-19%, respectively; P less than .001). That difference was seen as early as week four.
Both studies also demonstrated that treatment with ivermectin 1% was significantly superior to the control vehicle in reducing lesion counts, with significance seen as early as week two and continuing for the duration of the study. Patients in the treatment groups in both studies showed an average reduction of more than 20 lesions, while controls in the two studies had reductions of 12 and 13.4 lesions, respectively.
Fewer treatment-related adverse events were reported in the ivermectin group, compared with the control group (3.4% vs. 7.2%, respectively). The most common treatment-related adverse event in the first study was sensation of skin burning (1.8% in the ivermectin group vs. 2.6% in controls) while the most common adverse event in the second study were pruritus and dry skin (0.7% and 0.9%, respectively). "This drug was exceptionally well tolerated, very safe as well as efficacious," Dr. Stein Gold said.
In an interview, she acknowledged certain limitations of the study, including the fact that "we did not look at maintenance of efficacy when a patient stops the drug. However, that is being looked at in other studies."
The study was funded by Galderma R&D. Dr. Stein Gold disclosed that she is a consultant for Galderma.
DENVER – Ivermectin 1% cream applied once daily was effective and safe in treating patients with moderate to severe papulopustular rosacea, based on data from a pair of phase III studies.
Ivermectin 1% cream, a novel agent being developed by Galderma Laboratories, is of interest to rosacea researchers because it possesses unique anti-inflammatory and anti-parasitic properties, Dr. Linda Stein Gold said at the annual meeting of the American Academy of Dermatology.
Dr. Stein Gold of the department of dermatology at Henry Ford Medical Center, Detroit, explained that Demodex folliculorum, which is typically found on the human face, may trigger an immune response in rosacea patients. Ivermectin 1% is anti-parasitic against Demodex, providing an "innovative treatment" option in this patient population, she said. The investigational agent has not yet been approved by the Food and Drug Administration.
Dr. Stein Gold and her associates set out to assess the efficacy and safety of 1% ivermectin cream vs. a control vehicle cream in patients with moderate to severe papulopustular rosacea. The design included two identical, double-blind, parallel group, 12-week studies.
In both studies, a total of 910 patients were randomized 2:1 to receive 1% ivermectin cream or a control cream once daily. There were two co-primary endpoints: the percentage of patients who achieved a "clear" or "almost clear" score on the Investigator’s Global Assessment (IGA) scale at week 12, and the change in inflammatory lesion counts from baseline to week 12. The secondary efficacy endpoint assessment was the percentage change in inflammatory lesion count from baseline to week 12. The researchers also assessed safety endpoints by examining adverse events.
The mean age of patients was 50 years, 96% were white, and 67% were women. Patients had about 30 lesions each; 76-82% were classified as having moderate rosacea based on IGA score, and the rest had severe disease. More than 90% of patients in each arm completed the study through week 12.
At week 12 in both studies, a significantly higher percentage of patients in the treatment group achieved treatment success compared with those in the control group (38-40% vs. 12-19%, respectively; P less than .001). That difference was seen as early as week four.
Both studies also demonstrated that treatment with ivermectin 1% was significantly superior to the control vehicle in reducing lesion counts, with significance seen as early as week two and continuing for the duration of the study. Patients in the treatment groups in both studies showed an average reduction of more than 20 lesions, while controls in the two studies had reductions of 12 and 13.4 lesions, respectively.
Fewer treatment-related adverse events were reported in the ivermectin group, compared with the control group (3.4% vs. 7.2%, respectively). The most common treatment-related adverse event in the first study was sensation of skin burning (1.8% in the ivermectin group vs. 2.6% in controls) while the most common adverse event in the second study were pruritus and dry skin (0.7% and 0.9%, respectively). "This drug was exceptionally well tolerated, very safe as well as efficacious," Dr. Stein Gold said.
In an interview, she acknowledged certain limitations of the study, including the fact that "we did not look at maintenance of efficacy when a patient stops the drug. However, that is being looked at in other studies."
The study was funded by Galderma R&D. Dr. Stein Gold disclosed that she is a consultant for Galderma.
DENVER – Ivermectin 1% cream applied once daily was effective and safe in treating patients with moderate to severe papulopustular rosacea, based on data from a pair of phase III studies.
Ivermectin 1% cream, a novel agent being developed by Galderma Laboratories, is of interest to rosacea researchers because it possesses unique anti-inflammatory and anti-parasitic properties, Dr. Linda Stein Gold said at the annual meeting of the American Academy of Dermatology.
Dr. Stein Gold of the department of dermatology at Henry Ford Medical Center, Detroit, explained that Demodex folliculorum, which is typically found on the human face, may trigger an immune response in rosacea patients. Ivermectin 1% is anti-parasitic against Demodex, providing an "innovative treatment" option in this patient population, she said. The investigational agent has not yet been approved by the Food and Drug Administration.
Dr. Stein Gold and her associates set out to assess the efficacy and safety of 1% ivermectin cream vs. a control vehicle cream in patients with moderate to severe papulopustular rosacea. The design included two identical, double-blind, parallel group, 12-week studies.
In both studies, a total of 910 patients were randomized 2:1 to receive 1% ivermectin cream or a control cream once daily. There were two co-primary endpoints: the percentage of patients who achieved a "clear" or "almost clear" score on the Investigator’s Global Assessment (IGA) scale at week 12, and the change in inflammatory lesion counts from baseline to week 12. The secondary efficacy endpoint assessment was the percentage change in inflammatory lesion count from baseline to week 12. The researchers also assessed safety endpoints by examining adverse events.
The mean age of patients was 50 years, 96% were white, and 67% were women. Patients had about 30 lesions each; 76-82% were classified as having moderate rosacea based on IGA score, and the rest had severe disease. More than 90% of patients in each arm completed the study through week 12.
At week 12 in both studies, a significantly higher percentage of patients in the treatment group achieved treatment success compared with those in the control group (38-40% vs. 12-19%, respectively; P less than .001). That difference was seen as early as week four.
Both studies also demonstrated that treatment with ivermectin 1% was significantly superior to the control vehicle in reducing lesion counts, with significance seen as early as week two and continuing for the duration of the study. Patients in the treatment groups in both studies showed an average reduction of more than 20 lesions, while controls in the two studies had reductions of 12 and 13.4 lesions, respectively.
Fewer treatment-related adverse events were reported in the ivermectin group, compared with the control group (3.4% vs. 7.2%, respectively). The most common treatment-related adverse event in the first study was sensation of skin burning (1.8% in the ivermectin group vs. 2.6% in controls) while the most common adverse event in the second study were pruritus and dry skin (0.7% and 0.9%, respectively). "This drug was exceptionally well tolerated, very safe as well as efficacious," Dr. Stein Gold said.
In an interview, she acknowledged certain limitations of the study, including the fact that "we did not look at maintenance of efficacy when a patient stops the drug. However, that is being looked at in other studies."
The study was funded by Galderma R&D. Dr. Stein Gold disclosed that she is a consultant for Galderma.
AT THE AAD ANNUAL MEETING
Major Finding: At week 12, a significantly higher percentage of rosacea patients in the ivermectin 1% cream treatment group achieved scores of "clear" or "almost clear" on the Investigator’s Global Assessment compared with those in the control group (38-40% vs. 12-19%, respectively; P less than .001).
Data Source: Two pivotal phase 3 studies in which 910 patients with moderate to severe papulopustular rosacea were randomized 2:1 to receive 1% ivermectin cream or a vehicle cream (control) once daily for 12 weeks.
Disclosures: The study was funded by Galderma R&D. Dr. Stein Gold disclosed that she is a consultant for Galderma.
VIDEO: Ivermectin shows promise for treating papulopustular rosacea
DENVER – A limited number of safe and effective topical medications are currently available to treat chronic papulopustular (inflammatory) rosacea. In a video interview at the annual meeting of the American Academy of Dermatology, Dr. Linda Stein Gold highlighted results of two pivotal phase 3 trials of ivermectin 1%, an investigational drug being evaluated for the treatment of the disorder. Both studies of ivermectin 1% cream met their co-primary efficacy endpoints of treatment success as defined by the Investigator’s Global Assessment (IGA) rating of clear skin and change in inflammatory lesion count.
DENVER – A limited number of safe and effective topical medications are currently available to treat chronic papulopustular (inflammatory) rosacea. In a video interview at the annual meeting of the American Academy of Dermatology, Dr. Linda Stein Gold highlighted results of two pivotal phase 3 trials of ivermectin 1%, an investigational drug being evaluated for the treatment of the disorder. Both studies of ivermectin 1% cream met their co-primary efficacy endpoints of treatment success as defined by the Investigator’s Global Assessment (IGA) rating of clear skin and change in inflammatory lesion count.
DENVER – A limited number of safe and effective topical medications are currently available to treat chronic papulopustular (inflammatory) rosacea. In a video interview at the annual meeting of the American Academy of Dermatology, Dr. Linda Stein Gold highlighted results of two pivotal phase 3 trials of ivermectin 1%, an investigational drug being evaluated for the treatment of the disorder. Both studies of ivermectin 1% cream met their co-primary efficacy endpoints of treatment success as defined by the Investigator’s Global Assessment (IGA) rating of clear skin and change in inflammatory lesion count.
AT THE AAD ANNUAL MEETING
VIDEO: Don’t be afraid to treat acne in pregnant patients
DENVER – When it comes to treating pregnant women with acne, Dr. Jonette Keri’s goal is to prevent scarring. Her main message: there are several safe treatment options for women before, during, and after pregnancy, so don’t be afraid to use them.
Dr. Keri, associate professor of dermatology at the University of Miami Miller School of Medicine and chief of the dermatology service at Miami VA Hospital, shares her practice pearls in this video interview.
On Twitter @naseemmiller
DENVER – When it comes to treating pregnant women with acne, Dr. Jonette Keri’s goal is to prevent scarring. Her main message: there are several safe treatment options for women before, during, and after pregnancy, so don’t be afraid to use them.
Dr. Keri, associate professor of dermatology at the University of Miami Miller School of Medicine and chief of the dermatology service at Miami VA Hospital, shares her practice pearls in this video interview.
On Twitter @naseemmiller
DENVER – When it comes to treating pregnant women with acne, Dr. Jonette Keri’s goal is to prevent scarring. Her main message: there are several safe treatment options for women before, during, and after pregnancy, so don’t be afraid to use them.
Dr. Keri, associate professor of dermatology at the University of Miami Miller School of Medicine and chief of the dermatology service at Miami VA Hospital, shares her practice pearls in this video interview.
On Twitter @naseemmiller
AT THE AAD ANNUAL MEETING
Nanotherapies make inroads in wound regeneration
DENVER – Move over, gauze, bandages, and moist wound-healing techniques. Nanomaterials are making significant inroads in wound regeneration.
Dr. Adam Friedman, director of dermatologic research at the Montefiore-Einstein College of Medicine, New York, highlighted four nanotherapies in the field of wound care.
• Antimicrobial nano-based dressings. The antibacterial properties of silver have been documented since 1000 B.C., said Dr. Friedman of the departments of dermatology and of physiology and biophysics at the medical school. Silver ions are believed to directly disrupt pathogen cell walls/membranes and suppress respiratory enzymes and electron transport components. Silver has been used commercially for decades, with demonstrated antimicrobial effects (Crede’s 1% silver nitrate eyedrops were used to prevent mother to child transmission of gonococcal eye infection); anti-inflammatory properties (silver nitrate is used in pleurodesis); and infection protection (silver nanoparticle–impregnated wound dressings prevent infection and enhance wound healing).
Silver nanoparticles have an "increased likelihood of directly interacting with the target bacteria or virus," Dr. Friedman said in an interview in advance of the annual meeting of the American Academy of Dermatology. "They bind to and/or disturb bacterial cell membrane activity as well as release silver ions much more readily then their bulk counterparts." Silver dressings currently on the market include Silvercel, Aquacel, and Acticoat.
Similarly to nanometals, the biological activity of curcumin (a water-insoluble polyphenolic compound derived from tumeric) can be used in the nanoform and has been shown to both effectively clear methicillin-resistant Staphylococcus aureus in burn wound infections and accelerate the healing of thermal burn wounds.
• Immunomodulating antimicrobial nanoparticles. One of the most promising immunomodulators in wound healing is the gaseous molecule nitric oxide (NO). This potential has yet to be realized, Dr. Friedman said, as NO is highly unstable and its site of action is often microns from its source of generation. Nanotechnology can allow for controlled and sustained release of this evasive biomolecule and make therapeutic translation a reality. "At Einstein, we are utilizing NO-generating nanoparticles to accelerate wound healing and eradicate multidrug resistant pathogens," he said. "But, because NO is integral to so many biological processes, it can do so much more. This technology is also being studied for the treatment of cardiovascular disease and even the topical treatment of erectile dysfunction."
• Gene modifying/silencing technologies. RNA interference is an endogenous mechanism to control gene expression in a variety of organisms. "We can take advantage of this process using siRNA (small interfering RNA) to manipulate limitless biological processes," Dr. Friedman explained. "While a hot area, translation to the bedside has been difficult as siRNA are very unstable and have a difficult time reaching their targets inside cells. Nanoparticles have been shown to overcome these limitations." Dr. Friedman noted how siRNA encapsulate nanoparticles targeting fidgetin-like 2 (an ATPase that cleaves microtubules), can knock down this gene in vivo, resulting in accelerated epithelial cell migration and hastened wound closure in both excisional and burn wound mouse models.
• Growth factor–releasing nanoparticles. Growth factors have been found to speed the healing of acute and chronic wounds in humans, including Regranex, a analogue of platelet-derived growth factor that is FDA-approved for treating leg and foot ulcers in diabetic patients, epidermal growth factor (donor-site wounds), fibroblast growth factor (burn wounds), and growth hormone (donor sites in burned children). "Nanomaterials offer many advantages here, from allowing for temporal release depending on the wound environment to delivering multiple factors at the same or different times, to even serving as a structural foundation for wound healing while releasing factors simultaneously," Dr. Friedman said. "The possibilities are limitless."
Dr. Friedman characterized nanomedicine as "a newborn branch of science. These promising and innovative tools should help us overcome limitations of traditional wound care, improve direct intervention on phases of wound healing, and provide better solutions for wound dressing that induce favorable wound healing environments. More work – and funding – is needed."
Dr. Friedman disclosed that he is a consultant and/or a member of the scientific advisory board for SanovaWorks, Prodigy, Oakstone Institute, Liquidia Technologies, L’Oréal, Amgen, Onset, Aveeno, GSK, MicroCures, and Nano Bio-Med. He is also a speaker for Onset and Amgen.
This article was updated March 24, 2014.
DENVER – Move over, gauze, bandages, and moist wound-healing techniques. Nanomaterials are making significant inroads in wound regeneration.
Dr. Adam Friedman, director of dermatologic research at the Montefiore-Einstein College of Medicine, New York, highlighted four nanotherapies in the field of wound care.
• Antimicrobial nano-based dressings. The antibacterial properties of silver have been documented since 1000 B.C., said Dr. Friedman of the departments of dermatology and of physiology and biophysics at the medical school. Silver ions are believed to directly disrupt pathogen cell walls/membranes and suppress respiratory enzymes and electron transport components. Silver has been used commercially for decades, with demonstrated antimicrobial effects (Crede’s 1% silver nitrate eyedrops were used to prevent mother to child transmission of gonococcal eye infection); anti-inflammatory properties (silver nitrate is used in pleurodesis); and infection protection (silver nanoparticle–impregnated wound dressings prevent infection and enhance wound healing).
Silver nanoparticles have an "increased likelihood of directly interacting with the target bacteria or virus," Dr. Friedman said in an interview in advance of the annual meeting of the American Academy of Dermatology. "They bind to and/or disturb bacterial cell membrane activity as well as release silver ions much more readily then their bulk counterparts." Silver dressings currently on the market include Silvercel, Aquacel, and Acticoat.
Similarly to nanometals, the biological activity of curcumin (a water-insoluble polyphenolic compound derived from tumeric) can be used in the nanoform and has been shown to both effectively clear methicillin-resistant Staphylococcus aureus in burn wound infections and accelerate the healing of thermal burn wounds.
• Immunomodulating antimicrobial nanoparticles. One of the most promising immunomodulators in wound healing is the gaseous molecule nitric oxide (NO). This potential has yet to be realized, Dr. Friedman said, as NO is highly unstable and its site of action is often microns from its source of generation. Nanotechnology can allow for controlled and sustained release of this evasive biomolecule and make therapeutic translation a reality. "At Einstein, we are utilizing NO-generating nanoparticles to accelerate wound healing and eradicate multidrug resistant pathogens," he said. "But, because NO is integral to so many biological processes, it can do so much more. This technology is also being studied for the treatment of cardiovascular disease and even the topical treatment of erectile dysfunction."
• Gene modifying/silencing technologies. RNA interference is an endogenous mechanism to control gene expression in a variety of organisms. "We can take advantage of this process using siRNA (small interfering RNA) to manipulate limitless biological processes," Dr. Friedman explained. "While a hot area, translation to the bedside has been difficult as siRNA are very unstable and have a difficult time reaching their targets inside cells. Nanoparticles have been shown to overcome these limitations." Dr. Friedman noted how siRNA encapsulate nanoparticles targeting fidgetin-like 2 (an ATPase that cleaves microtubules), can knock down this gene in vivo, resulting in accelerated epithelial cell migration and hastened wound closure in both excisional and burn wound mouse models.
• Growth factor–releasing nanoparticles. Growth factors have been found to speed the healing of acute and chronic wounds in humans, including Regranex, a analogue of platelet-derived growth factor that is FDA-approved for treating leg and foot ulcers in diabetic patients, epidermal growth factor (donor-site wounds), fibroblast growth factor (burn wounds), and growth hormone (donor sites in burned children). "Nanomaterials offer many advantages here, from allowing for temporal release depending on the wound environment to delivering multiple factors at the same or different times, to even serving as a structural foundation for wound healing while releasing factors simultaneously," Dr. Friedman said. "The possibilities are limitless."
Dr. Friedman characterized nanomedicine as "a newborn branch of science. These promising and innovative tools should help us overcome limitations of traditional wound care, improve direct intervention on phases of wound healing, and provide better solutions for wound dressing that induce favorable wound healing environments. More work – and funding – is needed."
Dr. Friedman disclosed that he is a consultant and/or a member of the scientific advisory board for SanovaWorks, Prodigy, Oakstone Institute, Liquidia Technologies, L’Oréal, Amgen, Onset, Aveeno, GSK, MicroCures, and Nano Bio-Med. He is also a speaker for Onset and Amgen.
This article was updated March 24, 2014.
DENVER – Move over, gauze, bandages, and moist wound-healing techniques. Nanomaterials are making significant inroads in wound regeneration.
Dr. Adam Friedman, director of dermatologic research at the Montefiore-Einstein College of Medicine, New York, highlighted four nanotherapies in the field of wound care.
• Antimicrobial nano-based dressings. The antibacterial properties of silver have been documented since 1000 B.C., said Dr. Friedman of the departments of dermatology and of physiology and biophysics at the medical school. Silver ions are believed to directly disrupt pathogen cell walls/membranes and suppress respiratory enzymes and electron transport components. Silver has been used commercially for decades, with demonstrated antimicrobial effects (Crede’s 1% silver nitrate eyedrops were used to prevent mother to child transmission of gonococcal eye infection); anti-inflammatory properties (silver nitrate is used in pleurodesis); and infection protection (silver nanoparticle–impregnated wound dressings prevent infection and enhance wound healing).
Silver nanoparticles have an "increased likelihood of directly interacting with the target bacteria or virus," Dr. Friedman said in an interview in advance of the annual meeting of the American Academy of Dermatology. "They bind to and/or disturb bacterial cell membrane activity as well as release silver ions much more readily then their bulk counterparts." Silver dressings currently on the market include Silvercel, Aquacel, and Acticoat.
Similarly to nanometals, the biological activity of curcumin (a water-insoluble polyphenolic compound derived from tumeric) can be used in the nanoform and has been shown to both effectively clear methicillin-resistant Staphylococcus aureus in burn wound infections and accelerate the healing of thermal burn wounds.
• Immunomodulating antimicrobial nanoparticles. One of the most promising immunomodulators in wound healing is the gaseous molecule nitric oxide (NO). This potential has yet to be realized, Dr. Friedman said, as NO is highly unstable and its site of action is often microns from its source of generation. Nanotechnology can allow for controlled and sustained release of this evasive biomolecule and make therapeutic translation a reality. "At Einstein, we are utilizing NO-generating nanoparticles to accelerate wound healing and eradicate multidrug resistant pathogens," he said. "But, because NO is integral to so many biological processes, it can do so much more. This technology is also being studied for the treatment of cardiovascular disease and even the topical treatment of erectile dysfunction."
• Gene modifying/silencing technologies. RNA interference is an endogenous mechanism to control gene expression in a variety of organisms. "We can take advantage of this process using siRNA (small interfering RNA) to manipulate limitless biological processes," Dr. Friedman explained. "While a hot area, translation to the bedside has been difficult as siRNA are very unstable and have a difficult time reaching their targets inside cells. Nanoparticles have been shown to overcome these limitations." Dr. Friedman noted how siRNA encapsulate nanoparticles targeting fidgetin-like 2 (an ATPase that cleaves microtubules), can knock down this gene in vivo, resulting in accelerated epithelial cell migration and hastened wound closure in both excisional and burn wound mouse models.
• Growth factor–releasing nanoparticles. Growth factors have been found to speed the healing of acute and chronic wounds in humans, including Regranex, a analogue of platelet-derived growth factor that is FDA-approved for treating leg and foot ulcers in diabetic patients, epidermal growth factor (donor-site wounds), fibroblast growth factor (burn wounds), and growth hormone (donor sites in burned children). "Nanomaterials offer many advantages here, from allowing for temporal release depending on the wound environment to delivering multiple factors at the same or different times, to even serving as a structural foundation for wound healing while releasing factors simultaneously," Dr. Friedman said. "The possibilities are limitless."
Dr. Friedman characterized nanomedicine as "a newborn branch of science. These promising and innovative tools should help us overcome limitations of traditional wound care, improve direct intervention on phases of wound healing, and provide better solutions for wound dressing that induce favorable wound healing environments. More work – and funding – is needed."
Dr. Friedman disclosed that he is a consultant and/or a member of the scientific advisory board for SanovaWorks, Prodigy, Oakstone Institute, Liquidia Technologies, L’Oréal, Amgen, Onset, Aveeno, GSK, MicroCures, and Nano Bio-Med. He is also a speaker for Onset and Amgen.
This article was updated March 24, 2014.
AT THE AAD ANNUAL MEETING