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Tanuja Chitnis: “It’s the right time” for precision medicine in MS
DALLAS – In an interview at the meeting held by the Americas Committee for Treatment and Research in Multiple Sclerosis, the conference’s cochair, Tanuja Chitnis, MD, explained why this is the right time to take a deep dive into what precision medicine means in MS, for patients and physicians alike.
“We chose the topic of precision medicine for this forum because it’s a really timely issue,” said Dr. Chitnis, noting that there are now over 16 approved treatments for MS, and an increasing recognition that “not every patient has the same disease course.”
“It’s the right time to think about individualized treatment, and not a one-size-fits-all approach,” she said, noting that clinicians and patients stand to benefit from guidance about treatment choices.
“In addition, we are aided by the number of biomarkers that are becoming available,” including quantitative MRI and serum biomarkers. “I think we – as a field – need to understand how to use these in clinical settings in order to guide treatment decisions,” said Dr. Chitnis, professor of neurology at Harvard Medical School, Boston.
Advances in data science are allowing the connection of disparate kinds of data for discovery and hypothesis testing and validation, said Dr. Chitnis, who serves as medical director for the large longitudinal CLIMB study. The study follows about 2,000 patients who have yearly neurologic examinations and brain MRI; serum biomarkers and self-report data are also acquired annually.
“Network science can help in the precision medicine approach to multiple sclerosis, because we have a very clear understanding that MS is a complex disease. It is not one gene; it is not one modality,” she said.
Dr. Chitnis reported that she has received research funding from multiple pharmaceutical companies.
DALLAS – In an interview at the meeting held by the Americas Committee for Treatment and Research in Multiple Sclerosis, the conference’s cochair, Tanuja Chitnis, MD, explained why this is the right time to take a deep dive into what precision medicine means in MS, for patients and physicians alike.
“We chose the topic of precision medicine for this forum because it’s a really timely issue,” said Dr. Chitnis, noting that there are now over 16 approved treatments for MS, and an increasing recognition that “not every patient has the same disease course.”
“It’s the right time to think about individualized treatment, and not a one-size-fits-all approach,” she said, noting that clinicians and patients stand to benefit from guidance about treatment choices.
“In addition, we are aided by the number of biomarkers that are becoming available,” including quantitative MRI and serum biomarkers. “I think we – as a field – need to understand how to use these in clinical settings in order to guide treatment decisions,” said Dr. Chitnis, professor of neurology at Harvard Medical School, Boston.
Advances in data science are allowing the connection of disparate kinds of data for discovery and hypothesis testing and validation, said Dr. Chitnis, who serves as medical director for the large longitudinal CLIMB study. The study follows about 2,000 patients who have yearly neurologic examinations and brain MRI; serum biomarkers and self-report data are also acquired annually.
“Network science can help in the precision medicine approach to multiple sclerosis, because we have a very clear understanding that MS is a complex disease. It is not one gene; it is not one modality,” she said.
Dr. Chitnis reported that she has received research funding from multiple pharmaceutical companies.
DALLAS – In an interview at the meeting held by the Americas Committee for Treatment and Research in Multiple Sclerosis, the conference’s cochair, Tanuja Chitnis, MD, explained why this is the right time to take a deep dive into what precision medicine means in MS, for patients and physicians alike.
“We chose the topic of precision medicine for this forum because it’s a really timely issue,” said Dr. Chitnis, noting that there are now over 16 approved treatments for MS, and an increasing recognition that “not every patient has the same disease course.”
“It’s the right time to think about individualized treatment, and not a one-size-fits-all approach,” she said, noting that clinicians and patients stand to benefit from guidance about treatment choices.
“In addition, we are aided by the number of biomarkers that are becoming available,” including quantitative MRI and serum biomarkers. “I think we – as a field – need to understand how to use these in clinical settings in order to guide treatment decisions,” said Dr. Chitnis, professor of neurology at Harvard Medical School, Boston.
Advances in data science are allowing the connection of disparate kinds of data for discovery and hypothesis testing and validation, said Dr. Chitnis, who serves as medical director for the large longitudinal CLIMB study. The study follows about 2,000 patients who have yearly neurologic examinations and brain MRI; serum biomarkers and self-report data are also acquired annually.
“Network science can help in the precision medicine approach to multiple sclerosis, because we have a very clear understanding that MS is a complex disease. It is not one gene; it is not one modality,” she said.
Dr. Chitnis reported that she has received research funding from multiple pharmaceutical companies.
REPORTING FROM ACTRIMS FORUM 2019
Smartphone-based visual tests for MS patients show promise
DALLAS – A battery of smartphone-based tests has been developed to help detect visual pathway disturbances in MS patients and to follow them over time.
“One of the ideas is, can you design something that’s so easy to use and quick that it’s not a burden on the patient?” Randy H. Kardon, MD, PhD, said in an interview at the meeting held by the Americas Committee for Treatment and Research in Multiple Sclerosis. “The other was to test a couple of different modalities. By that I mean we test visual acuity, contrast sensitivity, and critical flicker fusion, which is a way of measuring the speed of conduction of nerves in the visual system.”
Dr. Kardon, professor of neuro-ophthalmology at the University of Iowa, Iowa City, worked with colleagues from Aalborg University, Denmark, to study these tests and a novel measure known as the vanishing optotype on 117 patients with MS and 103 age-matched controls. They found that the tests “very nicely discriminated between normal eyes from patients that had MS,” said Dr. Kardon, director of the Iowa City VA Center for Prevention and Treatment of Visual Loss. “Furthermore, we could determine which eyes from the MS patients had previous optic neuritis and which eyes hadn’t. We’re now looking for partners to go forward with larger studies to validate it further and refine these tests even more.”
Dr. Kardon disclosed that he has received funding from the National Eye Institute, the Department of Defense, and from VA Rehabilitation Research and Development. He was also a member of the Novartis steering committee for the OCTiMS study and is a cofounder of MedFace and FaceX.
DALLAS – A battery of smartphone-based tests has been developed to help detect visual pathway disturbances in MS patients and to follow them over time.
“One of the ideas is, can you design something that’s so easy to use and quick that it’s not a burden on the patient?” Randy H. Kardon, MD, PhD, said in an interview at the meeting held by the Americas Committee for Treatment and Research in Multiple Sclerosis. “The other was to test a couple of different modalities. By that I mean we test visual acuity, contrast sensitivity, and critical flicker fusion, which is a way of measuring the speed of conduction of nerves in the visual system.”
Dr. Kardon, professor of neuro-ophthalmology at the University of Iowa, Iowa City, worked with colleagues from Aalborg University, Denmark, to study these tests and a novel measure known as the vanishing optotype on 117 patients with MS and 103 age-matched controls. They found that the tests “very nicely discriminated between normal eyes from patients that had MS,” said Dr. Kardon, director of the Iowa City VA Center for Prevention and Treatment of Visual Loss. “Furthermore, we could determine which eyes from the MS patients had previous optic neuritis and which eyes hadn’t. We’re now looking for partners to go forward with larger studies to validate it further and refine these tests even more.”
Dr. Kardon disclosed that he has received funding from the National Eye Institute, the Department of Defense, and from VA Rehabilitation Research and Development. He was also a member of the Novartis steering committee for the OCTiMS study and is a cofounder of MedFace and FaceX.
DALLAS – A battery of smartphone-based tests has been developed to help detect visual pathway disturbances in MS patients and to follow them over time.
“One of the ideas is, can you design something that’s so easy to use and quick that it’s not a burden on the patient?” Randy H. Kardon, MD, PhD, said in an interview at the meeting held by the Americas Committee for Treatment and Research in Multiple Sclerosis. “The other was to test a couple of different modalities. By that I mean we test visual acuity, contrast sensitivity, and critical flicker fusion, which is a way of measuring the speed of conduction of nerves in the visual system.”
Dr. Kardon, professor of neuro-ophthalmology at the University of Iowa, Iowa City, worked with colleagues from Aalborg University, Denmark, to study these tests and a novel measure known as the vanishing optotype on 117 patients with MS and 103 age-matched controls. They found that the tests “very nicely discriminated between normal eyes from patients that had MS,” said Dr. Kardon, director of the Iowa City VA Center for Prevention and Treatment of Visual Loss. “Furthermore, we could determine which eyes from the MS patients had previous optic neuritis and which eyes hadn’t. We’re now looking for partners to go forward with larger studies to validate it further and refine these tests even more.”
Dr. Kardon disclosed that he has received funding from the National Eye Institute, the Department of Defense, and from VA Rehabilitation Research and Development. He was also a member of the Novartis steering committee for the OCTiMS study and is a cofounder of MedFace and FaceX.
REPORTING FROM ACTRIMS FORUM 2019
U.S. sesame allergy prevalence estimated at 750,000
SAN FRANCISCO – The estimated roughly about 750,000 people, according to a recent, representative survey of more than 78,000 Americans, which shows sesame allergy apparently is common enough to prompt the Food and Drug Administration to require food labels that identify sesame as an ingredient or possible contaminant.
The sesame-allergy data also showed that sesame reactions were rated as having been severe by about a third of respondents, they caused about two-thirds of people who responded to sesame to go to an emergency department at least once (the highest rate for this outcome among all food allergies), and reactions had led to use of an epinephrine automated injector by about a quarter of people who responded to it, Christopher M. Warren said at the annual meeting of the American Academy of Allergy, Asthma, and Immunology.
These findings document the public health importance of sesame allergy, which seems widespread and often severe enough to warrant making sesame the ninth allergen to require specific food labeling, said Ruchi S. Gupta, MD, senior author of the study and a professor of pediatrics and medicine at Northwestern University in Chicago.
“It seems to rank up with other food allergens regarding reaction severity,” Dr. Gupta said in a video interview. In October 2018, the FDA requested information on sesame allergy so that its staff could consider adding sesame to its list of major food allergens. The eight current major food allergens that require specific labeling are: peanut, tree nuts, eggs, milk, fish, shellfish, wheat, and soy. The 0.23% prevalence of sesame among U.S. residents makes it more common than certain tree nuts, and so the prevalence numbers also seem to justify adding sesame to the FDA’s labeling list because 750,000 is “a lot of people,” she noted.
An established surveying group based at the University of Chicago ran the data collection, which received responses from 53,575 U.S. household including 40,443 adults and 38,408 children. Dr. Gupta and her associates recently published information on the methods of the survey and other findings it made about U.S. food allergy rates (JAMA Network Open. 2019 Jan 4. doi: 10.1001/jamanetworkopen.2018.5630). The descriptions people provided about their food allergy diagnoses, and the effects these allergies had, underwent detailed review by a panel of experts who decide whether or not the evidence for an allergy was “convincing.” The 0.23% prevalence rate reported for sesame represented people for whom this allergy was convincingly demonstrated, reflected a confirmed physician diagnosis, or both, and hence it was a conservative estimate, Dr. Gupta said.
Mr. Warren had no disclosures. Dr. Gupta has been a consultant to Aimmune, Before Brands, DBV Technologies, Kaleo, Mylan, and Pfizer, and she has received research funding from Aimmune, Mylan, the National Confectioners Association, Rho, and Thermo Fisher.
SOURCE: Chadha AS et al. AAAAI 2019, Abstract 615.
SAN FRANCISCO – The estimated roughly about 750,000 people, according to a recent, representative survey of more than 78,000 Americans, which shows sesame allergy apparently is common enough to prompt the Food and Drug Administration to require food labels that identify sesame as an ingredient or possible contaminant.
The sesame-allergy data also showed that sesame reactions were rated as having been severe by about a third of respondents, they caused about two-thirds of people who responded to sesame to go to an emergency department at least once (the highest rate for this outcome among all food allergies), and reactions had led to use of an epinephrine automated injector by about a quarter of people who responded to it, Christopher M. Warren said at the annual meeting of the American Academy of Allergy, Asthma, and Immunology.
These findings document the public health importance of sesame allergy, which seems widespread and often severe enough to warrant making sesame the ninth allergen to require specific food labeling, said Ruchi S. Gupta, MD, senior author of the study and a professor of pediatrics and medicine at Northwestern University in Chicago.
“It seems to rank up with other food allergens regarding reaction severity,” Dr. Gupta said in a video interview. In October 2018, the FDA requested information on sesame allergy so that its staff could consider adding sesame to its list of major food allergens. The eight current major food allergens that require specific labeling are: peanut, tree nuts, eggs, milk, fish, shellfish, wheat, and soy. The 0.23% prevalence of sesame among U.S. residents makes it more common than certain tree nuts, and so the prevalence numbers also seem to justify adding sesame to the FDA’s labeling list because 750,000 is “a lot of people,” she noted.
An established surveying group based at the University of Chicago ran the data collection, which received responses from 53,575 U.S. household including 40,443 adults and 38,408 children. Dr. Gupta and her associates recently published information on the methods of the survey and other findings it made about U.S. food allergy rates (JAMA Network Open. 2019 Jan 4. doi: 10.1001/jamanetworkopen.2018.5630). The descriptions people provided about their food allergy diagnoses, and the effects these allergies had, underwent detailed review by a panel of experts who decide whether or not the evidence for an allergy was “convincing.” The 0.23% prevalence rate reported for sesame represented people for whom this allergy was convincingly demonstrated, reflected a confirmed physician diagnosis, or both, and hence it was a conservative estimate, Dr. Gupta said.
Mr. Warren had no disclosures. Dr. Gupta has been a consultant to Aimmune, Before Brands, DBV Technologies, Kaleo, Mylan, and Pfizer, and she has received research funding from Aimmune, Mylan, the National Confectioners Association, Rho, and Thermo Fisher.
SOURCE: Chadha AS et al. AAAAI 2019, Abstract 615.
SAN FRANCISCO – The estimated roughly about 750,000 people, according to a recent, representative survey of more than 78,000 Americans, which shows sesame allergy apparently is common enough to prompt the Food and Drug Administration to require food labels that identify sesame as an ingredient or possible contaminant.
The sesame-allergy data also showed that sesame reactions were rated as having been severe by about a third of respondents, they caused about two-thirds of people who responded to sesame to go to an emergency department at least once (the highest rate for this outcome among all food allergies), and reactions had led to use of an epinephrine automated injector by about a quarter of people who responded to it, Christopher M. Warren said at the annual meeting of the American Academy of Allergy, Asthma, and Immunology.
These findings document the public health importance of sesame allergy, which seems widespread and often severe enough to warrant making sesame the ninth allergen to require specific food labeling, said Ruchi S. Gupta, MD, senior author of the study and a professor of pediatrics and medicine at Northwestern University in Chicago.
“It seems to rank up with other food allergens regarding reaction severity,” Dr. Gupta said in a video interview. In October 2018, the FDA requested information on sesame allergy so that its staff could consider adding sesame to its list of major food allergens. The eight current major food allergens that require specific labeling are: peanut, tree nuts, eggs, milk, fish, shellfish, wheat, and soy. The 0.23% prevalence of sesame among U.S. residents makes it more common than certain tree nuts, and so the prevalence numbers also seem to justify adding sesame to the FDA’s labeling list because 750,000 is “a lot of people,” she noted.
An established surveying group based at the University of Chicago ran the data collection, which received responses from 53,575 U.S. household including 40,443 adults and 38,408 children. Dr. Gupta and her associates recently published information on the methods of the survey and other findings it made about U.S. food allergy rates (JAMA Network Open. 2019 Jan 4. doi: 10.1001/jamanetworkopen.2018.5630). The descriptions people provided about their food allergy diagnoses, and the effects these allergies had, underwent detailed review by a panel of experts who decide whether or not the evidence for an allergy was “convincing.” The 0.23% prevalence rate reported for sesame represented people for whom this allergy was convincingly demonstrated, reflected a confirmed physician diagnosis, or both, and hence it was a conservative estimate, Dr. Gupta said.
Mr. Warren had no disclosures. Dr. Gupta has been a consultant to Aimmune, Before Brands, DBV Technologies, Kaleo, Mylan, and Pfizer, and she has received research funding from Aimmune, Mylan, the National Confectioners Association, Rho, and Thermo Fisher.
SOURCE: Chadha AS et al. AAAAI 2019, Abstract 615.
REPORTING FROM AAAAI 2019
Key clinical point: The U.S. prevalence of allergy to sesame is roughly similar to other foods that require food labeling.
Major finding: The prevalence of sesame allergy was 0.23% of U.S. adults and children.
Study details: A detailed survey of food allergies completed for 53,575 U.S. households that included 78,851 people.
Disclosures: Mr. Warren had no disclosures. Dr. Gupta had been a consultant to Aimmune, Before Brands, DBV Technologies, Kaleo, Mylan, and Pfizer, and she had received research funding from Aimmune, Mylan, the National Confectioners Association, Rho, and Thermo Fisher.
Source: Chadha AS et al. AAAAI 2019, Abstract 615.
TCA and punch excision are two options for icepick acne scars
WAIKOLOA, HAWAII – Dermatologists can certainly improve icepick acne scars, but they have to be careful not to make them worse, according to dermatologist Nazanin Saedi, MD, director of the Jefferson Laser Surgery and Cosmetic Dermatology Center at Thomas Jefferson University, Philadelphia.
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After about three to five TCA treatments, most patients will have a better than 50% improvement, Dr. Saedi said, but the treatment isn’t for darker skin types – Fitzpatrick types V or VI – because of the risk of pigmentation changes. Dr. Saedi uses toothpicks to apply a small amount of 80% TCA to the base of the scar, and waits for the “frost” to appear. It’s important not to reapply the TCA. “A lot of people double dip and ... keep dipping into the scar,” which causes more damage.
For patients with darker skin types, or those who don’t want to go through a series of treatments, punch excision is an option, with nonablative laser treatment a week later when sutures are removed. “Some patients heal beautifully,” but some patients may have a spread scar or a small atrophic scar at the punch site, she noted. Options to treat atrophic scarring after treatment are laser treatments and fillers.
She offered her advice in an interview at the Hawaii Dermatology Seminar, provided by the Global Academy for Medical Education/Skin Disease Education Foundation. It’s important to set realistic expectations, Dr. Saedi said.
SDEF/Global Academy for Medical Education and this news organization are owned by the same parent company.
WAIKOLOA, HAWAII – Dermatologists can certainly improve icepick acne scars, but they have to be careful not to make them worse, according to dermatologist Nazanin Saedi, MD, director of the Jefferson Laser Surgery and Cosmetic Dermatology Center at Thomas Jefferson University, Philadelphia.
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After about three to five TCA treatments, most patients will have a better than 50% improvement, Dr. Saedi said, but the treatment isn’t for darker skin types – Fitzpatrick types V or VI – because of the risk of pigmentation changes. Dr. Saedi uses toothpicks to apply a small amount of 80% TCA to the base of the scar, and waits for the “frost” to appear. It’s important not to reapply the TCA. “A lot of people double dip and ... keep dipping into the scar,” which causes more damage.
For patients with darker skin types, or those who don’t want to go through a series of treatments, punch excision is an option, with nonablative laser treatment a week later when sutures are removed. “Some patients heal beautifully,” but some patients may have a spread scar or a small atrophic scar at the punch site, she noted. Options to treat atrophic scarring after treatment are laser treatments and fillers.
She offered her advice in an interview at the Hawaii Dermatology Seminar, provided by the Global Academy for Medical Education/Skin Disease Education Foundation. It’s important to set realistic expectations, Dr. Saedi said.
SDEF/Global Academy for Medical Education and this news organization are owned by the same parent company.
WAIKOLOA, HAWAII – Dermatologists can certainly improve icepick acne scars, but they have to be careful not to make them worse, according to dermatologist Nazanin Saedi, MD, director of the Jefferson Laser Surgery and Cosmetic Dermatology Center at Thomas Jefferson University, Philadelphia.
.
After about three to five TCA treatments, most patients will have a better than 50% improvement, Dr. Saedi said, but the treatment isn’t for darker skin types – Fitzpatrick types V or VI – because of the risk of pigmentation changes. Dr. Saedi uses toothpicks to apply a small amount of 80% TCA to the base of the scar, and waits for the “frost” to appear. It’s important not to reapply the TCA. “A lot of people double dip and ... keep dipping into the scar,” which causes more damage.
For patients with darker skin types, or those who don’t want to go through a series of treatments, punch excision is an option, with nonablative laser treatment a week later when sutures are removed. “Some patients heal beautifully,” but some patients may have a spread scar or a small atrophic scar at the punch site, she noted. Options to treat atrophic scarring after treatment are laser treatments and fillers.
She offered her advice in an interview at the Hawaii Dermatology Seminar, provided by the Global Academy for Medical Education/Skin Disease Education Foundation. It’s important to set realistic expectations, Dr. Saedi said.
SDEF/Global Academy for Medical Education and this news organization are owned by the same parent company.
EXPERT ANALYSIS FROM SDEF HAWAII DERMATOLOGY SEMINAR
Dupilumab relieves severe sinusitis with polyposis
SAN FRANCISCO – Dupilumab, an anti-inflammatory drug already approved for use in the United States, met its efficacy endpoints for treating chronic rhinosinusitis with nasal polyps in a pivotal trial with 276 patients.
The results make it likely that dupilumab (Dupixent) will receive a new indication from the Food and Drug Administration, pending similar results in a second pivotal trial for nasal polyps that researchers will report soon. Dupilumab, which works by blocking a receptor for both interleukin 4 and interleukin 13 and thereby shutting down type 2 inflammation, is already approved in the United States for treating atopic dermatitis and asthma.
Type 2 inflammation drives polyp formation in patients with chronic rhinosinusitis that can produce severe nasal congestion, breathing difficulty, and substantially reduced quality of life.
In the new trial, the drug showed efficacy by significantly improving both the nasal congestion score reported by patients and the nasal polyp score measured by sinus endoscopy after 24 weeks on treatment, when compared with control patients on placebo, Joseph K. Han, MD, said at the annual meeting of the American Academy of Allergy, Asthma, and Immunology.
Patients enrolled in the study had chronic, severe sinusitis and nasal polyps that remained uncontrolled despite prior surgery, for 75% of enrolled patients, or treatment with systemic corticosteroids, used on about 90% of the patients within the prior 2 years.
During the 24 weeks of treatment, 23% of patients in the control arm had to restart systemic corticosteroid treatment or have surgery, compared with 7% of patients on dupilumab treatment, a statistically significant difference.
The new drug is a “game changer,” for these patients, Dr. Han said in a video interview.
In some patients, treatment produced complete polyp resolution. He and his colleagues in the otolaryngology field are now trying to decide exactly which patients with polyps secondary to sinusitis will be good candidates for dupilumab after it receives an expected indication for shrinking nasal polyps.
Roughly 4% of the adult population has chronic rhinosinusitis that generates polyps. How many of these patients are affected severely enough to warrant dupilumab treatment is not clear, but will likely include several hundreds of thousands of U.S. adults, said Dr. Han, professor of otolaryngology and chief of the division of allergy at Eastern Virginia Medical School in Norfolk.
The SINUS-24 (A Controlled Clinical Study of Dupilumab in Patients With Nasal Polyps) trial enrolled patients at 76 sites in the United States and in several European countries. The study randomized 143 patients who received standard treatment plus a 300-mg dupilumab subcutaneous injection every 2 weeks, and 133 patients who received standard treatment plus placebo injections. Standard treatment included a nasal corticosteroid spray.
After 24 weeks of treatment, the endoscopically-measured nasal polyp score, which averaged about 6 at baseline on a scale of 0-8, fell by an average of 2.06 points, compared with controls, which was a statistically significant and clinically meaningful change, said Dr. Han.
The second primary endpoint, patient self-assessment of nasal congestion on a scale of 0-3, showed an average 0.89 improvement, compared with controls, which was also a statistically significant and meaningful change from the average baseline score of about 2.4.
Other efficacy measures also showed benefits from treatment, including a substantial improvement compared with controls in a quality-of-life measure. The safety profile was benign compared with placebo, and consistent with existing safety data for the drug.SINUS-24 was funded by Regeneron and Sanofi, the companies that market dupilumab. Dr. Han has been an adviser to Regeneron and Sanofi.
SOURCE: Han JK et al. AAAAI 2019, Abstract L4.
SAN FRANCISCO – Dupilumab, an anti-inflammatory drug already approved for use in the United States, met its efficacy endpoints for treating chronic rhinosinusitis with nasal polyps in a pivotal trial with 276 patients.
The results make it likely that dupilumab (Dupixent) will receive a new indication from the Food and Drug Administration, pending similar results in a second pivotal trial for nasal polyps that researchers will report soon. Dupilumab, which works by blocking a receptor for both interleukin 4 and interleukin 13 and thereby shutting down type 2 inflammation, is already approved in the United States for treating atopic dermatitis and asthma.
Type 2 inflammation drives polyp formation in patients with chronic rhinosinusitis that can produce severe nasal congestion, breathing difficulty, and substantially reduced quality of life.
In the new trial, the drug showed efficacy by significantly improving both the nasal congestion score reported by patients and the nasal polyp score measured by sinus endoscopy after 24 weeks on treatment, when compared with control patients on placebo, Joseph K. Han, MD, said at the annual meeting of the American Academy of Allergy, Asthma, and Immunology.
Patients enrolled in the study had chronic, severe sinusitis and nasal polyps that remained uncontrolled despite prior surgery, for 75% of enrolled patients, or treatment with systemic corticosteroids, used on about 90% of the patients within the prior 2 years.
During the 24 weeks of treatment, 23% of patients in the control arm had to restart systemic corticosteroid treatment or have surgery, compared with 7% of patients on dupilumab treatment, a statistically significant difference.
The new drug is a “game changer,” for these patients, Dr. Han said in a video interview.
In some patients, treatment produced complete polyp resolution. He and his colleagues in the otolaryngology field are now trying to decide exactly which patients with polyps secondary to sinusitis will be good candidates for dupilumab after it receives an expected indication for shrinking nasal polyps.
Roughly 4% of the adult population has chronic rhinosinusitis that generates polyps. How many of these patients are affected severely enough to warrant dupilumab treatment is not clear, but will likely include several hundreds of thousands of U.S. adults, said Dr. Han, professor of otolaryngology and chief of the division of allergy at Eastern Virginia Medical School in Norfolk.
The SINUS-24 (A Controlled Clinical Study of Dupilumab in Patients With Nasal Polyps) trial enrolled patients at 76 sites in the United States and in several European countries. The study randomized 143 patients who received standard treatment plus a 300-mg dupilumab subcutaneous injection every 2 weeks, and 133 patients who received standard treatment plus placebo injections. Standard treatment included a nasal corticosteroid spray.
After 24 weeks of treatment, the endoscopically-measured nasal polyp score, which averaged about 6 at baseline on a scale of 0-8, fell by an average of 2.06 points, compared with controls, which was a statistically significant and clinically meaningful change, said Dr. Han.
The second primary endpoint, patient self-assessment of nasal congestion on a scale of 0-3, showed an average 0.89 improvement, compared with controls, which was also a statistically significant and meaningful change from the average baseline score of about 2.4.
Other efficacy measures also showed benefits from treatment, including a substantial improvement compared with controls in a quality-of-life measure. The safety profile was benign compared with placebo, and consistent with existing safety data for the drug.SINUS-24 was funded by Regeneron and Sanofi, the companies that market dupilumab. Dr. Han has been an adviser to Regeneron and Sanofi.
SOURCE: Han JK et al. AAAAI 2019, Abstract L4.
SAN FRANCISCO – Dupilumab, an anti-inflammatory drug already approved for use in the United States, met its efficacy endpoints for treating chronic rhinosinusitis with nasal polyps in a pivotal trial with 276 patients.
The results make it likely that dupilumab (Dupixent) will receive a new indication from the Food and Drug Administration, pending similar results in a second pivotal trial for nasal polyps that researchers will report soon. Dupilumab, which works by blocking a receptor for both interleukin 4 and interleukin 13 and thereby shutting down type 2 inflammation, is already approved in the United States for treating atopic dermatitis and asthma.
Type 2 inflammation drives polyp formation in patients with chronic rhinosinusitis that can produce severe nasal congestion, breathing difficulty, and substantially reduced quality of life.
In the new trial, the drug showed efficacy by significantly improving both the nasal congestion score reported by patients and the nasal polyp score measured by sinus endoscopy after 24 weeks on treatment, when compared with control patients on placebo, Joseph K. Han, MD, said at the annual meeting of the American Academy of Allergy, Asthma, and Immunology.
Patients enrolled in the study had chronic, severe sinusitis and nasal polyps that remained uncontrolled despite prior surgery, for 75% of enrolled patients, or treatment with systemic corticosteroids, used on about 90% of the patients within the prior 2 years.
During the 24 weeks of treatment, 23% of patients in the control arm had to restart systemic corticosteroid treatment or have surgery, compared with 7% of patients on dupilumab treatment, a statistically significant difference.
The new drug is a “game changer,” for these patients, Dr. Han said in a video interview.
In some patients, treatment produced complete polyp resolution. He and his colleagues in the otolaryngology field are now trying to decide exactly which patients with polyps secondary to sinusitis will be good candidates for dupilumab after it receives an expected indication for shrinking nasal polyps.
Roughly 4% of the adult population has chronic rhinosinusitis that generates polyps. How many of these patients are affected severely enough to warrant dupilumab treatment is not clear, but will likely include several hundreds of thousands of U.S. adults, said Dr. Han, professor of otolaryngology and chief of the division of allergy at Eastern Virginia Medical School in Norfolk.
The SINUS-24 (A Controlled Clinical Study of Dupilumab in Patients With Nasal Polyps) trial enrolled patients at 76 sites in the United States and in several European countries. The study randomized 143 patients who received standard treatment plus a 300-mg dupilumab subcutaneous injection every 2 weeks, and 133 patients who received standard treatment plus placebo injections. Standard treatment included a nasal corticosteroid spray.
After 24 weeks of treatment, the endoscopically-measured nasal polyp score, which averaged about 6 at baseline on a scale of 0-8, fell by an average of 2.06 points, compared with controls, which was a statistically significant and clinically meaningful change, said Dr. Han.
The second primary endpoint, patient self-assessment of nasal congestion on a scale of 0-3, showed an average 0.89 improvement, compared with controls, which was also a statistically significant and meaningful change from the average baseline score of about 2.4.
Other efficacy measures also showed benefits from treatment, including a substantial improvement compared with controls in a quality-of-life measure. The safety profile was benign compared with placebo, and consistent with existing safety data for the drug.SINUS-24 was funded by Regeneron and Sanofi, the companies that market dupilumab. Dr. Han has been an adviser to Regeneron and Sanofi.
SOURCE: Han JK et al. AAAAI 2019, Abstract L4.
REPORTING FROM AAAAI
Simple treatments can address bleeding in dermatologic surgery
WAIKOLOA, HAWAII – “Nothing can ruin your day more than a lot of bleeding,” said Mohs surgeon Daniel Siegel, MD, clinical professor of dermatology at the State University of New York Downstate Medical Center, New York.
“Part of planning for surgery is to prevent that sort of problem,” and fortunately, and some are very inexpensive. There’s even a “fancy form of potato starch” that can be left in the wound and sewn over, he said in an interview at the Hawaii Dermatology Seminar, provided by Global Academy for Medical Education/Skin Disease Education Foundation.
During the interview, Dr. Siegel described several options and how to use them. They are good products to have on hand in the clinic, just in case, he said.
SDEF/Global Academy for Medical Education and this news organization and are owned by the same parent company.
WAIKOLOA, HAWAII – “Nothing can ruin your day more than a lot of bleeding,” said Mohs surgeon Daniel Siegel, MD, clinical professor of dermatology at the State University of New York Downstate Medical Center, New York.
“Part of planning for surgery is to prevent that sort of problem,” and fortunately, and some are very inexpensive. There’s even a “fancy form of potato starch” that can be left in the wound and sewn over, he said in an interview at the Hawaii Dermatology Seminar, provided by Global Academy for Medical Education/Skin Disease Education Foundation.
During the interview, Dr. Siegel described several options and how to use them. They are good products to have on hand in the clinic, just in case, he said.
SDEF/Global Academy for Medical Education and this news organization and are owned by the same parent company.
WAIKOLOA, HAWAII – “Nothing can ruin your day more than a lot of bleeding,” said Mohs surgeon Daniel Siegel, MD, clinical professor of dermatology at the State University of New York Downstate Medical Center, New York.
“Part of planning for surgery is to prevent that sort of problem,” and fortunately, and some are very inexpensive. There’s even a “fancy form of potato starch” that can be left in the wound and sewn over, he said in an interview at the Hawaii Dermatology Seminar, provided by Global Academy for Medical Education/Skin Disease Education Foundation.
During the interview, Dr. Siegel described several options and how to use them. They are good products to have on hand in the clinic, just in case, he said.
SDEF/Global Academy for Medical Education and this news organization and are owned by the same parent company.
EXPERT ANALYSIS FROM SDEF HAWAII DERMATOLOGY SEMINAR
Dupilumab conjunctivitis does not always require an ophthalmologist referral
WAIKOLOA, HAWAII – Since its approval in 2017, dupilumab (Dupixent) has proven to be a solid addition to the atopic dermatitis (AD) armamentarium.
About 80% to 85% of patients treated with the biologic will achieve a 50% reduction in their Eczema Area and Severity Index score, and some will go on to a 90% reduction, according to Jonathan Silverberg, MD, PhD, of the department of dermatology, Northwestern University, Chicago.
But Dr. Silverberg has seen it in his own practice and said it can be hard to know whether or not to refer to ophthalmology. “We’re often left with this conundrum of ... ‘Is it a side effect of the medication, or is it just because they happen to have hay fever or keratoconjunctivitis or other ophthalmic comorbidities?’ And it’s not always easy to sort out.”
In an interview at the Hawaii Dermatology Seminar, provided by Global Academy for Medical Education/Skin Disease Education Foundation, he offered his advice on managing a patient who develops conjunctivitis during dupilumab treatment, including his treatment tips for when it is safe to handle in the dermatology clinic.
Dr. Silverberg, who was an investigator in the dupilumab phase 3 trials, said that, while dupilumab is the only systemic agent approved by the Food and Drug Administration for treating AD, and more are on the way for AD, there will always still be a role for traditional immunosuppressives. He explained why in the interview and why he favors methotrexate when old school options are in order.
This news organization and SDEF/Global Academy for Medical Education are owned by the same parent company.
WAIKOLOA, HAWAII – Since its approval in 2017, dupilumab (Dupixent) has proven to be a solid addition to the atopic dermatitis (AD) armamentarium.
About 80% to 85% of patients treated with the biologic will achieve a 50% reduction in their Eczema Area and Severity Index score, and some will go on to a 90% reduction, according to Jonathan Silverberg, MD, PhD, of the department of dermatology, Northwestern University, Chicago.
But Dr. Silverberg has seen it in his own practice and said it can be hard to know whether or not to refer to ophthalmology. “We’re often left with this conundrum of ... ‘Is it a side effect of the medication, or is it just because they happen to have hay fever or keratoconjunctivitis or other ophthalmic comorbidities?’ And it’s not always easy to sort out.”
In an interview at the Hawaii Dermatology Seminar, provided by Global Academy for Medical Education/Skin Disease Education Foundation, he offered his advice on managing a patient who develops conjunctivitis during dupilumab treatment, including his treatment tips for when it is safe to handle in the dermatology clinic.
Dr. Silverberg, who was an investigator in the dupilumab phase 3 trials, said that, while dupilumab is the only systemic agent approved by the Food and Drug Administration for treating AD, and more are on the way for AD, there will always still be a role for traditional immunosuppressives. He explained why in the interview and why he favors methotrexate when old school options are in order.
This news organization and SDEF/Global Academy for Medical Education are owned by the same parent company.
WAIKOLOA, HAWAII – Since its approval in 2017, dupilumab (Dupixent) has proven to be a solid addition to the atopic dermatitis (AD) armamentarium.
About 80% to 85% of patients treated with the biologic will achieve a 50% reduction in their Eczema Area and Severity Index score, and some will go on to a 90% reduction, according to Jonathan Silverberg, MD, PhD, of the department of dermatology, Northwestern University, Chicago.
But Dr. Silverberg has seen it in his own practice and said it can be hard to know whether or not to refer to ophthalmology. “We’re often left with this conundrum of ... ‘Is it a side effect of the medication, or is it just because they happen to have hay fever or keratoconjunctivitis or other ophthalmic comorbidities?’ And it’s not always easy to sort out.”
In an interview at the Hawaii Dermatology Seminar, provided by Global Academy for Medical Education/Skin Disease Education Foundation, he offered his advice on managing a patient who develops conjunctivitis during dupilumab treatment, including his treatment tips for when it is safe to handle in the dermatology clinic.
Dr. Silverberg, who was an investigator in the dupilumab phase 3 trials, said that, while dupilumab is the only systemic agent approved by the Food and Drug Administration for treating AD, and more are on the way for AD, there will always still be a role for traditional immunosuppressives. He explained why in the interview and why he favors methotrexate when old school options are in order.
This news organization and SDEF/Global Academy for Medical Education are owned by the same parent company.
EXPERT ANALYSIS FROM THE SDEF HAWAII DERMATOLOGY SEMINAR
Onychomycosis that fails terbinafine probably isn’t T. rubrum
WAIKOLOA, HAWAII – The work up of a case of onychomycosis doesn’t end with the detection of fungal hyphae.
Trichophyton rubrum remains the most common cause of toenail fungus in the United States, but nondermatophyte molds – Scopulariopsis, Fusarium, and others – are on the rise, so , according to Nathaniel Jellinek, MD, of the department of dermatology, Brown University, Providence, R.I.
Standard in-office potassium hydroxide (KOH) testing can’t distinguish one species of fungus from another, nor can pathology with Gomori methenamine silver (GMS) or Periodic acid-Schiff (PAS) staining. Both culture and polymerase chain reaction (PCR), however, do.
Since few hospitals are equipped to run those tests, Dr. Jellinek uses the Case Western Center for Medical Mycology, in Cleveland, for testing.
In an interview at the Hawaii Dermatology Seminar provided by the Global Academy for Medical Education/Skin Disease Education Foundation, Dr. Jellinek explained how to speciate, and the importance of doing so.
He also shared his tips on getting good nail clippings and good scrapings for debris for testing, and explained when KOH testing is enough – and when to opt for more advanced diagnostic methods, including PCR, which he said trumps all previous methods.
Terbinafine is still the best option for T. rubrum, but new topicals are better for nondermatophyte molds. There’s also a clever new dosing regimen for terbinafine, one that should put patients at ease about liver toxicity and other concerns. “If you tell them they’re getting 1 month off in the middle, it seems to go over a little easier,” Dr. Jellinek said.
SDEF/Global Academy for Medical Education and this news organization are owned by the same parent company.
WAIKOLOA, HAWAII – The work up of a case of onychomycosis doesn’t end with the detection of fungal hyphae.
Trichophyton rubrum remains the most common cause of toenail fungus in the United States, but nondermatophyte molds – Scopulariopsis, Fusarium, and others – are on the rise, so , according to Nathaniel Jellinek, MD, of the department of dermatology, Brown University, Providence, R.I.
Standard in-office potassium hydroxide (KOH) testing can’t distinguish one species of fungus from another, nor can pathology with Gomori methenamine silver (GMS) or Periodic acid-Schiff (PAS) staining. Both culture and polymerase chain reaction (PCR), however, do.
Since few hospitals are equipped to run those tests, Dr. Jellinek uses the Case Western Center for Medical Mycology, in Cleveland, for testing.
In an interview at the Hawaii Dermatology Seminar provided by the Global Academy for Medical Education/Skin Disease Education Foundation, Dr. Jellinek explained how to speciate, and the importance of doing so.
He also shared his tips on getting good nail clippings and good scrapings for debris for testing, and explained when KOH testing is enough – and when to opt for more advanced diagnostic methods, including PCR, which he said trumps all previous methods.
Terbinafine is still the best option for T. rubrum, but new topicals are better for nondermatophyte molds. There’s also a clever new dosing regimen for terbinafine, one that should put patients at ease about liver toxicity and other concerns. “If you tell them they’re getting 1 month off in the middle, it seems to go over a little easier,” Dr. Jellinek said.
SDEF/Global Academy for Medical Education and this news organization are owned by the same parent company.
WAIKOLOA, HAWAII – The work up of a case of onychomycosis doesn’t end with the detection of fungal hyphae.
Trichophyton rubrum remains the most common cause of toenail fungus in the United States, but nondermatophyte molds – Scopulariopsis, Fusarium, and others – are on the rise, so , according to Nathaniel Jellinek, MD, of the department of dermatology, Brown University, Providence, R.I.
Standard in-office potassium hydroxide (KOH) testing can’t distinguish one species of fungus from another, nor can pathology with Gomori methenamine silver (GMS) or Periodic acid-Schiff (PAS) staining. Both culture and polymerase chain reaction (PCR), however, do.
Since few hospitals are equipped to run those tests, Dr. Jellinek uses the Case Western Center for Medical Mycology, in Cleveland, for testing.
In an interview at the Hawaii Dermatology Seminar provided by the Global Academy for Medical Education/Skin Disease Education Foundation, Dr. Jellinek explained how to speciate, and the importance of doing so.
He also shared his tips on getting good nail clippings and good scrapings for debris for testing, and explained when KOH testing is enough – and when to opt for more advanced diagnostic methods, including PCR, which he said trumps all previous methods.
Terbinafine is still the best option for T. rubrum, but new topicals are better for nondermatophyte molds. There’s also a clever new dosing regimen for terbinafine, one that should put patients at ease about liver toxicity and other concerns. “If you tell them they’re getting 1 month off in the middle, it seems to go over a little easier,” Dr. Jellinek said.
SDEF/Global Academy for Medical Education and this news organization are owned by the same parent company.
EXPERT ANALYSIS FROM SDEF HAWAII DERMATOLOGY SEMINAR
How to surf the rosacea treatment algorithm
WAIKOLOA, HAWAII – according to Linda Stein Gold, MD, director of dermatology research at Henry Ford Hospital in Detroit.
Papules and pustules need an oral or topical anti-inflammatory drug. Background erythema requires an alpha adrenergic agonist. Telangiectasia is best handled by a laser device, and if a patient has a phyma, “you’ve got to use a surgical approach,” she said at the Hawaii Dermatology Seminar provided by Global Academy for Medical Education/Skin Disease Education Foundation. It sounds simple, but there are decisions to be made about what drugs and formulations to use, and when, and when to combine them.
In an interview, Dr. Stein Gold shared her approach to treatment, along with the latest on using ivermectin and brimonidine together, plus her thoughts on new medications under development and the role of the Demodex mite in rosacea.
SDEF/Global Academy for Medical Education and this news organization are owned by the same parent company.
WAIKOLOA, HAWAII – according to Linda Stein Gold, MD, director of dermatology research at Henry Ford Hospital in Detroit.
Papules and pustules need an oral or topical anti-inflammatory drug. Background erythema requires an alpha adrenergic agonist. Telangiectasia is best handled by a laser device, and if a patient has a phyma, “you’ve got to use a surgical approach,” she said at the Hawaii Dermatology Seminar provided by Global Academy for Medical Education/Skin Disease Education Foundation. It sounds simple, but there are decisions to be made about what drugs and formulations to use, and when, and when to combine them.
In an interview, Dr. Stein Gold shared her approach to treatment, along with the latest on using ivermectin and brimonidine together, plus her thoughts on new medications under development and the role of the Demodex mite in rosacea.
SDEF/Global Academy for Medical Education and this news organization are owned by the same parent company.
WAIKOLOA, HAWAII – according to Linda Stein Gold, MD, director of dermatology research at Henry Ford Hospital in Detroit.
Papules and pustules need an oral or topical anti-inflammatory drug. Background erythema requires an alpha adrenergic agonist. Telangiectasia is best handled by a laser device, and if a patient has a phyma, “you’ve got to use a surgical approach,” she said at the Hawaii Dermatology Seminar provided by Global Academy for Medical Education/Skin Disease Education Foundation. It sounds simple, but there are decisions to be made about what drugs and formulations to use, and when, and when to combine them.
In an interview, Dr. Stein Gold shared her approach to treatment, along with the latest on using ivermectin and brimonidine together, plus her thoughts on new medications under development and the role of the Demodex mite in rosacea.
SDEF/Global Academy for Medical Education and this news organization are owned by the same parent company.
EXPERT ANALYSIS FROM SDEF HAWAII DERMATOLOGY SEMINAR
Don’t fear spironolactone, isotretinoin, OCs for acne
WAIKOLOA, HAWAII – There’s really , of the department of dermatology at the University of Alabama at Birmingham.
There have been concerns with all three in the past, but most of the worries have been recently laid to rest.
The news hasn’t reached everyone, though, so, by and large, they are “tools I think we are not using enough of,” Dr. Harper said in an interview. With isotretinoin, for instance, it really isn’t necessary to do blood work for lipids and liver function every month, a daunting prospect for patients; baseline testing with a repeat at 2 months is sufficient, as long as there’s no dose escalation and results are acceptable, with the exception of a monthly pregnancy test for women, she noted. Meanwhile, there’s no evidence of a link with inflammatory bowel disease, and wound healing isn’t as much of an issue as once thought.
It’s the same story with spironolactone. Hyperkalemia is a long-standing concern, but it turns out that “in healthy young women taking spironolactone for acne, we don’t need to be checking potassium.” As far as breast cancer goes, the potential risk with spironolactone hasn’t panned out in the literature, and there may not be “a link at all,” Dr. Harper said at the Hawaii Dermatology Seminar provided by the Global Academy for Medical Education/Skin Disease Education Foundation.
There are caveats, of course. Hormonal treatments shouldn’t be used in young women until they’ve established their menstrual cycle. OCs should not be used in smokers, or people who have hypertension or migraines, among other conditions. Also, elevated triglycerides remain a concern with isotretinoin. “The number I would want people to remember is 500 [mg/dL],” the threshold when triglycerides become a problem.
In the interview, Dr. Harper explained the new thinking on these three options, and shared her treatment tips, including what to do if patients’ triglycerides hit the 500 mg/dL mark.
SDEF/Global Academy for Medical Education and this news organization are owned by the same parent company.
WAIKOLOA, HAWAII – There’s really , of the department of dermatology at the University of Alabama at Birmingham.
There have been concerns with all three in the past, but most of the worries have been recently laid to rest.
The news hasn’t reached everyone, though, so, by and large, they are “tools I think we are not using enough of,” Dr. Harper said in an interview. With isotretinoin, for instance, it really isn’t necessary to do blood work for lipids and liver function every month, a daunting prospect for patients; baseline testing with a repeat at 2 months is sufficient, as long as there’s no dose escalation and results are acceptable, with the exception of a monthly pregnancy test for women, she noted. Meanwhile, there’s no evidence of a link with inflammatory bowel disease, and wound healing isn’t as much of an issue as once thought.
It’s the same story with spironolactone. Hyperkalemia is a long-standing concern, but it turns out that “in healthy young women taking spironolactone for acne, we don’t need to be checking potassium.” As far as breast cancer goes, the potential risk with spironolactone hasn’t panned out in the literature, and there may not be “a link at all,” Dr. Harper said at the Hawaii Dermatology Seminar provided by the Global Academy for Medical Education/Skin Disease Education Foundation.
There are caveats, of course. Hormonal treatments shouldn’t be used in young women until they’ve established their menstrual cycle. OCs should not be used in smokers, or people who have hypertension or migraines, among other conditions. Also, elevated triglycerides remain a concern with isotretinoin. “The number I would want people to remember is 500 [mg/dL],” the threshold when triglycerides become a problem.
In the interview, Dr. Harper explained the new thinking on these three options, and shared her treatment tips, including what to do if patients’ triglycerides hit the 500 mg/dL mark.
SDEF/Global Academy for Medical Education and this news organization are owned by the same parent company.
WAIKOLOA, HAWAII – There’s really , of the department of dermatology at the University of Alabama at Birmingham.
There have been concerns with all three in the past, but most of the worries have been recently laid to rest.
The news hasn’t reached everyone, though, so, by and large, they are “tools I think we are not using enough of,” Dr. Harper said in an interview. With isotretinoin, for instance, it really isn’t necessary to do blood work for lipids and liver function every month, a daunting prospect for patients; baseline testing with a repeat at 2 months is sufficient, as long as there’s no dose escalation and results are acceptable, with the exception of a monthly pregnancy test for women, she noted. Meanwhile, there’s no evidence of a link with inflammatory bowel disease, and wound healing isn’t as much of an issue as once thought.
It’s the same story with spironolactone. Hyperkalemia is a long-standing concern, but it turns out that “in healthy young women taking spironolactone for acne, we don’t need to be checking potassium.” As far as breast cancer goes, the potential risk with spironolactone hasn’t panned out in the literature, and there may not be “a link at all,” Dr. Harper said at the Hawaii Dermatology Seminar provided by the Global Academy for Medical Education/Skin Disease Education Foundation.
There are caveats, of course. Hormonal treatments shouldn’t be used in young women until they’ve established their menstrual cycle. OCs should not be used in smokers, or people who have hypertension or migraines, among other conditions. Also, elevated triglycerides remain a concern with isotretinoin. “The number I would want people to remember is 500 [mg/dL],” the threshold when triglycerides become a problem.
In the interview, Dr. Harper explained the new thinking on these three options, and shared her treatment tips, including what to do if patients’ triglycerides hit the 500 mg/dL mark.
SDEF/Global Academy for Medical Education and this news organization are owned by the same parent company.
EXPERT ANALYSIS FROM SDEF HAWAII DERMATOLOGY SEMINAR
