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FDA aims to increase safety of platelet transfusions
The U.S. Food and Drug Administration (FDA) recently released a draft guidance on reducing the risk of bacterial contamination in platelets destined for transfusion, especially those stored at room temperature.
The recommendations in this guidance incorporate ideas put forth during a July meeting of the Blood Products Advisory Committee.
Committee members were asked to discuss the advantages and disadvantages of various strategies to control the risk of bacterial contamination in platelets, including the scientific evidence and the operational considerations involved.
Since the last guidance document on this topic was issued in 2016, there have been new developments that could potentially reduce the risk of bacterial contamination of platelets and permit extension of platelet dating up to 7 days.
These developments include bacterial testing strategies using culture-based devices, rapid bacterial detection devices, and the implementation of pathogen-reduction technology.
The new draft guidance “further advances the potential for technology to be used to reduce the risk of contamination of the blood supply from known and emerging pathogens and to measurably increase the availability of safe blood products while ultimately reducing cost overall,” said FDA Commissioner Scott Gottlieb, MD.
“The U.S. has one of the world’s safest blood supplies, but there remains risk, albeit uncommon, of contamination with infectious diseases, particularly with blood products that are stored at room temperature. While we’ve made great strides in reducing the risk of blood contamination through donor screening and laboratory testing, we continue to support innovations and blood product alternatives that can better keep pace with emerging pathogens and reduce some of the logistical challenges and costs associated with ensuring the safety of blood products.”
The draft guidance, “Bacterial Risk Control Strategies for Blood Collection Establishments and Transfusion Services to Enhance the Safety and Availability of Platelets for Transfusion,” will be open for public comment through February 4, 2019.
Comments may be submitted online at https://www.regulations.gov/ or by mail to the Dockets Management Staff (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
The U.S. Food and Drug Administration (FDA) recently released a draft guidance on reducing the risk of bacterial contamination in platelets destined for transfusion, especially those stored at room temperature.
The recommendations in this guidance incorporate ideas put forth during a July meeting of the Blood Products Advisory Committee.
Committee members were asked to discuss the advantages and disadvantages of various strategies to control the risk of bacterial contamination in platelets, including the scientific evidence and the operational considerations involved.
Since the last guidance document on this topic was issued in 2016, there have been new developments that could potentially reduce the risk of bacterial contamination of platelets and permit extension of platelet dating up to 7 days.
These developments include bacterial testing strategies using culture-based devices, rapid bacterial detection devices, and the implementation of pathogen-reduction technology.
The new draft guidance “further advances the potential for technology to be used to reduce the risk of contamination of the blood supply from known and emerging pathogens and to measurably increase the availability of safe blood products while ultimately reducing cost overall,” said FDA Commissioner Scott Gottlieb, MD.
“The U.S. has one of the world’s safest blood supplies, but there remains risk, albeit uncommon, of contamination with infectious diseases, particularly with blood products that are stored at room temperature. While we’ve made great strides in reducing the risk of blood contamination through donor screening and laboratory testing, we continue to support innovations and blood product alternatives that can better keep pace with emerging pathogens and reduce some of the logistical challenges and costs associated with ensuring the safety of blood products.”
The draft guidance, “Bacterial Risk Control Strategies for Blood Collection Establishments and Transfusion Services to Enhance the Safety and Availability of Platelets for Transfusion,” will be open for public comment through February 4, 2019.
Comments may be submitted online at https://www.regulations.gov/ or by mail to the Dockets Management Staff (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
The U.S. Food and Drug Administration (FDA) recently released a draft guidance on reducing the risk of bacterial contamination in platelets destined for transfusion, especially those stored at room temperature.
The recommendations in this guidance incorporate ideas put forth during a July meeting of the Blood Products Advisory Committee.
Committee members were asked to discuss the advantages and disadvantages of various strategies to control the risk of bacterial contamination in platelets, including the scientific evidence and the operational considerations involved.
Since the last guidance document on this topic was issued in 2016, there have been new developments that could potentially reduce the risk of bacterial contamination of platelets and permit extension of platelet dating up to 7 days.
These developments include bacterial testing strategies using culture-based devices, rapid bacterial detection devices, and the implementation of pathogen-reduction technology.
The new draft guidance “further advances the potential for technology to be used to reduce the risk of contamination of the blood supply from known and emerging pathogens and to measurably increase the availability of safe blood products while ultimately reducing cost overall,” said FDA Commissioner Scott Gottlieb, MD.
“The U.S. has one of the world’s safest blood supplies, but there remains risk, albeit uncommon, of contamination with infectious diseases, particularly with blood products that are stored at room temperature. While we’ve made great strides in reducing the risk of blood contamination through donor screening and laboratory testing, we continue to support innovations and blood product alternatives that can better keep pace with emerging pathogens and reduce some of the logistical challenges and costs associated with ensuring the safety of blood products.”
The draft guidance, “Bacterial Risk Control Strategies for Blood Collection Establishments and Transfusion Services to Enhance the Safety and Availability of Platelets for Transfusion,” will be open for public comment through February 4, 2019.
Comments may be submitted online at https://www.regulations.gov/ or by mail to the Dockets Management Staff (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
What’s in the way of you and new tech?
BOSTON – Bringing new technology to your practice is not as simple as flipping a switch, as attendees of the Thursday afternoon AGA Tech Summit session “Physician Perspective on Barriers to Incorporating New Technology” learned. The Tech Summit is sponsored by the AGA Center for GI Innovation and Technology.
“As physicians think about being a part of taking on new technology, there are varying perspectives, including the perspective they have about their patients and the perspective they have for themselves,” Richard Rothstein, MD, chair of the department of medicine at Geisel School of Medicine at Dartmouth, Hanover, N.H., said in an interview. “However, there are other perspectives as well, like the perspectives of the hospital or the ambulatory endoscopy center in which they work.”
He presented an intriguing historical example. Within months of the first demonstration of anesthetized surgery in 1846, the use of ether and the machine to deliver it were spreading rapidly through hospitals in large U.S. cities. European adoption soon followed.
However, decades passed before there was wide acceptance of Lister’s ideas on carbolic acid as a surgical antiseptic.
“Why was one technology adopted early and one later? Incentives to adopt both went in the same direction – improved patient outcomes. Both were based on ideas that violated prior beliefs. Both were technically complex. But one combatted a visible and immediate problem: pain. The other combatted an invisible and unproven problem: germs. Both made life better for the patient – but only one made life better for the surgeon. And that one, anesthesia, was the one that was quickly adopted.”
Even today, clinicians are the main drivers of the adoption of novel medical technology. They fall into two general categories, Dr. Rothstein said: early adopters, who want to be the first to offer an exciting new procedure, and late adopters, who wait for more information and want all the issues of that technology to be sorted out before diving in.
Each one stands in the same circle, however, forced to evaluate the issues that come along with adopting new tech, including training, credentialing and insurance, facility support, and how the new tool or procedure might affect the entire clinical team
Facilities have to tussle with these issues, too, Dr. Rothstein said.
Administrations wonder, “‘Will I get paid for this? Will it displace something else that’s equally effective that could be making more money? What resources do I need to implement it? Will it impact malpractice insurance rates for clinicians who work at my facility?’”
Patient choice also plays into the matter. Third-party payers may or may not have cutting-edge tech on their payment ledger. The specter of a self-pay procedure, no matter how potentially effective, is an enormous deterrent for patients, especially when figuring in the possibility of footing the bill for any associated complications. And of course, new technology and procedures lack the deep pool of efficacy and safety data that established ones lean upon – another potential sticking point for both clinicians and patients, Dr. Rothstein said.
“There are a lot of great ideas out there, and a lot of innovative devices, but without addressing the barriers to adoption, the technology will never get to the targeted goal of delivering better care to our patients,” he said.
BOSTON – Bringing new technology to your practice is not as simple as flipping a switch, as attendees of the Thursday afternoon AGA Tech Summit session “Physician Perspective on Barriers to Incorporating New Technology” learned. The Tech Summit is sponsored by the AGA Center for GI Innovation and Technology.
“As physicians think about being a part of taking on new technology, there are varying perspectives, including the perspective they have about their patients and the perspective they have for themselves,” Richard Rothstein, MD, chair of the department of medicine at Geisel School of Medicine at Dartmouth, Hanover, N.H., said in an interview. “However, there are other perspectives as well, like the perspectives of the hospital or the ambulatory endoscopy center in which they work.”
He presented an intriguing historical example. Within months of the first demonstration of anesthetized surgery in 1846, the use of ether and the machine to deliver it were spreading rapidly through hospitals in large U.S. cities. European adoption soon followed.
However, decades passed before there was wide acceptance of Lister’s ideas on carbolic acid as a surgical antiseptic.
“Why was one technology adopted early and one later? Incentives to adopt both went in the same direction – improved patient outcomes. Both were based on ideas that violated prior beliefs. Both were technically complex. But one combatted a visible and immediate problem: pain. The other combatted an invisible and unproven problem: germs. Both made life better for the patient – but only one made life better for the surgeon. And that one, anesthesia, was the one that was quickly adopted.”
Even today, clinicians are the main drivers of the adoption of novel medical technology. They fall into two general categories, Dr. Rothstein said: early adopters, who want to be the first to offer an exciting new procedure, and late adopters, who wait for more information and want all the issues of that technology to be sorted out before diving in.
Each one stands in the same circle, however, forced to evaluate the issues that come along with adopting new tech, including training, credentialing and insurance, facility support, and how the new tool or procedure might affect the entire clinical team
Facilities have to tussle with these issues, too, Dr. Rothstein said.
Administrations wonder, “‘Will I get paid for this? Will it displace something else that’s equally effective that could be making more money? What resources do I need to implement it? Will it impact malpractice insurance rates for clinicians who work at my facility?’”
Patient choice also plays into the matter. Third-party payers may or may not have cutting-edge tech on their payment ledger. The specter of a self-pay procedure, no matter how potentially effective, is an enormous deterrent for patients, especially when figuring in the possibility of footing the bill for any associated complications. And of course, new technology and procedures lack the deep pool of efficacy and safety data that established ones lean upon – another potential sticking point for both clinicians and patients, Dr. Rothstein said.
“There are a lot of great ideas out there, and a lot of innovative devices, but without addressing the barriers to adoption, the technology will never get to the targeted goal of delivering better care to our patients,” he said.
BOSTON – Bringing new technology to your practice is not as simple as flipping a switch, as attendees of the Thursday afternoon AGA Tech Summit session “Physician Perspective on Barriers to Incorporating New Technology” learned. The Tech Summit is sponsored by the AGA Center for GI Innovation and Technology.
“As physicians think about being a part of taking on new technology, there are varying perspectives, including the perspective they have about their patients and the perspective they have for themselves,” Richard Rothstein, MD, chair of the department of medicine at Geisel School of Medicine at Dartmouth, Hanover, N.H., said in an interview. “However, there are other perspectives as well, like the perspectives of the hospital or the ambulatory endoscopy center in which they work.”
He presented an intriguing historical example. Within months of the first demonstration of anesthetized surgery in 1846, the use of ether and the machine to deliver it were spreading rapidly through hospitals in large U.S. cities. European adoption soon followed.
However, decades passed before there was wide acceptance of Lister’s ideas on carbolic acid as a surgical antiseptic.
“Why was one technology adopted early and one later? Incentives to adopt both went in the same direction – improved patient outcomes. Both were based on ideas that violated prior beliefs. Both were technically complex. But one combatted a visible and immediate problem: pain. The other combatted an invisible and unproven problem: germs. Both made life better for the patient – but only one made life better for the surgeon. And that one, anesthesia, was the one that was quickly adopted.”
Even today, clinicians are the main drivers of the adoption of novel medical technology. They fall into two general categories, Dr. Rothstein said: early adopters, who want to be the first to offer an exciting new procedure, and late adopters, who wait for more information and want all the issues of that technology to be sorted out before diving in.
Each one stands in the same circle, however, forced to evaluate the issues that come along with adopting new tech, including training, credentialing and insurance, facility support, and how the new tool or procedure might affect the entire clinical team
Facilities have to tussle with these issues, too, Dr. Rothstein said.
Administrations wonder, “‘Will I get paid for this? Will it displace something else that’s equally effective that could be making more money? What resources do I need to implement it? Will it impact malpractice insurance rates for clinicians who work at my facility?’”
Patient choice also plays into the matter. Third-party payers may or may not have cutting-edge tech on their payment ledger. The specter of a self-pay procedure, no matter how potentially effective, is an enormous deterrent for patients, especially when figuring in the possibility of footing the bill for any associated complications. And of course, new technology and procedures lack the deep pool of efficacy and safety data that established ones lean upon – another potential sticking point for both clinicians and patients, Dr. Rothstein said.
“There are a lot of great ideas out there, and a lot of innovative devices, but without addressing the barriers to adoption, the technology will never get to the targeted goal of delivering better care to our patients,” he said.
REPORTING FROM 2018 AGA TECH SUMMIT
Tips for avoiding, taming most postlaser complications
SAN DIEGO – Do not use the fractional laser on tanned skin or skin that will be getting sun exposure soon after the treatment, Tina Alster, MD, advised as one of her cardinal rules for avoiding hyperpigmentation complications.
Melanocytes are already activated and ready to deposit pigment in such patients. Also, use strict posttreatment sun protection with a mineral sunscreen, she said.
Fractional lasers – both ablative and nonablative – are remarkably safe, said Dr. Alster of Georgetown University Medical Center, Washington.
Her own 2008 study found side effects and complications in just 7.6% of 961 patients. The most frequent were acneiform eruptions (1.8%) and herpes simplex virus outbreaks (1.7%).
A more recent study comprising 730 patients treated with three different fractional lasers found an even lower complication rate of 4%. Complications included 5 herpes simplex virus breakouts, 13 acne eruptions, one abrasion, one bacterial infection, 9 cases of dermatitis, one drug eruption, 4 cases of prolonged erythema, one case of hyperpigmentation, one case of increased swelling and one of telangiectasia.
“We consistently find these very low incidences of less than 10%, and most of these I would term ‘side effects’ and not true complications,” Dr. Alster said at the annual meeting of the American Academy of Dermatology.
Still, if a clinician performs enough laser procedures, these outcomes will eventually occur. Dr. Alster gave her “top tips” for dealing with them when they do arise.
Tip #1: Adequate preoperative assessment
“You must be thorough in assessing all of these things: the type and location of the lesion, the Fitzpatrick skin phototype, any prior treatments the patient has had for the condition (and many have had them). We need to know of any pre-existing medical conditions, particularly autoimmune, and whether the patient has a history of scarring or delayed wound healing.”
Another part of this assessment is managing patient expectations upfront to avoid postprocedural dissatisfaction. “If someone comes to me and says ‘I want you to get rid of every acne scar on my face,’ I tell them right there, ‘I can’t do that,’” she said.
Tip #2: Prepare the patient for the expected – and the unexpected
“The overall risk of even the most common side effects, like prolonged erythema, is relatively small. But they can happen and patients need to be prepared for them.” The most common are prolonged erythema of more than 4 days for nonablative fractional lasers and more than a month for ablative lasers. But dermatitis may appear, as well as reactivation of acne, especially in patients who are having acne scars removed. There is also always the risk of infection and pigmentary alteration.”
Tip #3: Proper technique and close follow-up
The most expensive laser in the world still relies on good technique during deployment, she said. “I always stress, do not ‘pulse stack.’ Use side-by-side, nonoverlapping passes.”
Another key for success is to avoid using the laser on any tanned skin, or skin that will soon have sun exposure. “Any skin phototype with recent sun exposure has activated melanocytes and will have a higher tendency to develop postinflammatory hyperpigmentation. The cells are already activated and in the presence of any other damage – including a laser – they are programmed to produce more pigment.”
Individualize your treatment plan, she advised. “Do additional passes on the most severe areas, like cheek scars and perioral rhytides, and fewer passes and lower density on scar-prone areas, like the infraorbital area, mandible neck, and chest.”
Tip #4: Recognize and address complications
“Complications run the full spectrum from mild erythema to disseminated infections. I am always careful to figure out if it’s a true complication or an expected side effect. The greatest risk profiles are patients with darker skin phototypes, treatments in more sensitive areas, and patients with predisposing medical conditions like collagen or vascular diseases. You don’t need to avoid treating them, just be prepared for the higher risks.”
Dr. Alster also shared her techniques for managing some of the more common adverse events following a fractional laser procedure.
Prolonged erythema isn’t clinically serious, but it really bothers patients. They should be counseled to avoid putting any potentially irritating or allergenic product on their face, and that includes chemical sunscreens. A mineral sunscreen is a much better choice. “For management, postoperative cooling with ice packs is important. A mild topical corticosteroid and a nonsteroidal anti-inflammatory can help, too.”
Acne exacerbation is not uncommon, especially among patients being treated for acne scars. “In people who are prone to acne, I write a script for doxycycline. They don’t have to take it unless they break out. And I always avoid laser skin resurfacing in active acne.”
If a breakout does happen, stick to the well-trodden path, she advised. “We know how to treat acne. Discontinue any occlusive topical, start the patent on an antibiotic, treat topically with a clay masque to help dry things out.”
Infections can be alarming but are manageable when promptly treated. “The main thing is to diagnose and treat early. In those patients who are proven to have herpes simplex virus, I give an antiviral, like valacyclovir. I give 1 gram twice a day for a week, starting on the day of the procedure. I think a bigger question is, ‘Does everyone need a prophylactic antibiotic?’ There is probably no reason to start one routinely, and in fact, there is some evidence that if you do, you may get a more pathogenic organism if you do get an infection.”
Hyperpigmentation is always a concern. Dr Alster repeated her cardinal rule: Do not use the fractional laser on tanned skin or skin that will be getting sun exposure soon after the treatment, as melanocytes are already activated and ready to deposit pigment. Use strict posttreatment sun protection with a mineral sunscreen. While she is not “a big fan” of hydroquinone, Dr. Alster does employ other bleaching agents for postoperative hyperpigmentation, including alpha hydroxyl acid, retinoic acid, kojic acid, and lignin peroxidase.
Good technique and aftercare reduce the risk of hypertrophic scarring. This means avoiding excessive fluences and aggressive lasering techniques and early treatment of any suspected infection. “My main treatment is the 585nm pulsed dye laser, but the main thing is to avoid aggressive techniques with overlapping or stacking of pulses, strict wound care, and early treatment of any infections.”
Dr. Alster disclosed that she is a consultant to L’Oréal USA, an investigator for Revance Therapeutics and Sente Labs, and a medical advisor to Merz Aesthetics, and has investments/commercial interests in Home Skinovations.
SOURCE: Alster, T. et al, PREVENTION & MANAGEMENT OF
SAN DIEGO – Do not use the fractional laser on tanned skin or skin that will be getting sun exposure soon after the treatment, Tina Alster, MD, advised as one of her cardinal rules for avoiding hyperpigmentation complications.
Melanocytes are already activated and ready to deposit pigment in such patients. Also, use strict posttreatment sun protection with a mineral sunscreen, she said.
Fractional lasers – both ablative and nonablative – are remarkably safe, said Dr. Alster of Georgetown University Medical Center, Washington.
Her own 2008 study found side effects and complications in just 7.6% of 961 patients. The most frequent were acneiform eruptions (1.8%) and herpes simplex virus outbreaks (1.7%).
A more recent study comprising 730 patients treated with three different fractional lasers found an even lower complication rate of 4%. Complications included 5 herpes simplex virus breakouts, 13 acne eruptions, one abrasion, one bacterial infection, 9 cases of dermatitis, one drug eruption, 4 cases of prolonged erythema, one case of hyperpigmentation, one case of increased swelling and one of telangiectasia.
“We consistently find these very low incidences of less than 10%, and most of these I would term ‘side effects’ and not true complications,” Dr. Alster said at the annual meeting of the American Academy of Dermatology.
Still, if a clinician performs enough laser procedures, these outcomes will eventually occur. Dr. Alster gave her “top tips” for dealing with them when they do arise.
Tip #1: Adequate preoperative assessment
“You must be thorough in assessing all of these things: the type and location of the lesion, the Fitzpatrick skin phototype, any prior treatments the patient has had for the condition (and many have had them). We need to know of any pre-existing medical conditions, particularly autoimmune, and whether the patient has a history of scarring or delayed wound healing.”
Another part of this assessment is managing patient expectations upfront to avoid postprocedural dissatisfaction. “If someone comes to me and says ‘I want you to get rid of every acne scar on my face,’ I tell them right there, ‘I can’t do that,’” she said.
Tip #2: Prepare the patient for the expected – and the unexpected
“The overall risk of even the most common side effects, like prolonged erythema, is relatively small. But they can happen and patients need to be prepared for them.” The most common are prolonged erythema of more than 4 days for nonablative fractional lasers and more than a month for ablative lasers. But dermatitis may appear, as well as reactivation of acne, especially in patients who are having acne scars removed. There is also always the risk of infection and pigmentary alteration.”
Tip #3: Proper technique and close follow-up
The most expensive laser in the world still relies on good technique during deployment, she said. “I always stress, do not ‘pulse stack.’ Use side-by-side, nonoverlapping passes.”
Another key for success is to avoid using the laser on any tanned skin, or skin that will soon have sun exposure. “Any skin phototype with recent sun exposure has activated melanocytes and will have a higher tendency to develop postinflammatory hyperpigmentation. The cells are already activated and in the presence of any other damage – including a laser – they are programmed to produce more pigment.”
Individualize your treatment plan, she advised. “Do additional passes on the most severe areas, like cheek scars and perioral rhytides, and fewer passes and lower density on scar-prone areas, like the infraorbital area, mandible neck, and chest.”
Tip #4: Recognize and address complications
“Complications run the full spectrum from mild erythema to disseminated infections. I am always careful to figure out if it’s a true complication or an expected side effect. The greatest risk profiles are patients with darker skin phototypes, treatments in more sensitive areas, and patients with predisposing medical conditions like collagen or vascular diseases. You don’t need to avoid treating them, just be prepared for the higher risks.”
Dr. Alster also shared her techniques for managing some of the more common adverse events following a fractional laser procedure.
Prolonged erythema isn’t clinically serious, but it really bothers patients. They should be counseled to avoid putting any potentially irritating or allergenic product on their face, and that includes chemical sunscreens. A mineral sunscreen is a much better choice. “For management, postoperative cooling with ice packs is important. A mild topical corticosteroid and a nonsteroidal anti-inflammatory can help, too.”
Acne exacerbation is not uncommon, especially among patients being treated for acne scars. “In people who are prone to acne, I write a script for doxycycline. They don’t have to take it unless they break out. And I always avoid laser skin resurfacing in active acne.”
If a breakout does happen, stick to the well-trodden path, she advised. “We know how to treat acne. Discontinue any occlusive topical, start the patent on an antibiotic, treat topically with a clay masque to help dry things out.”
Infections can be alarming but are manageable when promptly treated. “The main thing is to diagnose and treat early. In those patients who are proven to have herpes simplex virus, I give an antiviral, like valacyclovir. I give 1 gram twice a day for a week, starting on the day of the procedure. I think a bigger question is, ‘Does everyone need a prophylactic antibiotic?’ There is probably no reason to start one routinely, and in fact, there is some evidence that if you do, you may get a more pathogenic organism if you do get an infection.”
Hyperpigmentation is always a concern. Dr Alster repeated her cardinal rule: Do not use the fractional laser on tanned skin or skin that will be getting sun exposure soon after the treatment, as melanocytes are already activated and ready to deposit pigment. Use strict posttreatment sun protection with a mineral sunscreen. While she is not “a big fan” of hydroquinone, Dr. Alster does employ other bleaching agents for postoperative hyperpigmentation, including alpha hydroxyl acid, retinoic acid, kojic acid, and lignin peroxidase.
Good technique and aftercare reduce the risk of hypertrophic scarring. This means avoiding excessive fluences and aggressive lasering techniques and early treatment of any suspected infection. “My main treatment is the 585nm pulsed dye laser, but the main thing is to avoid aggressive techniques with overlapping or stacking of pulses, strict wound care, and early treatment of any infections.”
Dr. Alster disclosed that she is a consultant to L’Oréal USA, an investigator for Revance Therapeutics and Sente Labs, and a medical advisor to Merz Aesthetics, and has investments/commercial interests in Home Skinovations.
SOURCE: Alster, T. et al, PREVENTION & MANAGEMENT OF
SAN DIEGO – Do not use the fractional laser on tanned skin or skin that will be getting sun exposure soon after the treatment, Tina Alster, MD, advised as one of her cardinal rules for avoiding hyperpigmentation complications.
Melanocytes are already activated and ready to deposit pigment in such patients. Also, use strict posttreatment sun protection with a mineral sunscreen, she said.
Fractional lasers – both ablative and nonablative – are remarkably safe, said Dr. Alster of Georgetown University Medical Center, Washington.
Her own 2008 study found side effects and complications in just 7.6% of 961 patients. The most frequent were acneiform eruptions (1.8%) and herpes simplex virus outbreaks (1.7%).
A more recent study comprising 730 patients treated with three different fractional lasers found an even lower complication rate of 4%. Complications included 5 herpes simplex virus breakouts, 13 acne eruptions, one abrasion, one bacterial infection, 9 cases of dermatitis, one drug eruption, 4 cases of prolonged erythema, one case of hyperpigmentation, one case of increased swelling and one of telangiectasia.
“We consistently find these very low incidences of less than 10%, and most of these I would term ‘side effects’ and not true complications,” Dr. Alster said at the annual meeting of the American Academy of Dermatology.
Still, if a clinician performs enough laser procedures, these outcomes will eventually occur. Dr. Alster gave her “top tips” for dealing with them when they do arise.
Tip #1: Adequate preoperative assessment
“You must be thorough in assessing all of these things: the type and location of the lesion, the Fitzpatrick skin phototype, any prior treatments the patient has had for the condition (and many have had them). We need to know of any pre-existing medical conditions, particularly autoimmune, and whether the patient has a history of scarring or delayed wound healing.”
Another part of this assessment is managing patient expectations upfront to avoid postprocedural dissatisfaction. “If someone comes to me and says ‘I want you to get rid of every acne scar on my face,’ I tell them right there, ‘I can’t do that,’” she said.
Tip #2: Prepare the patient for the expected – and the unexpected
“The overall risk of even the most common side effects, like prolonged erythema, is relatively small. But they can happen and patients need to be prepared for them.” The most common are prolonged erythema of more than 4 days for nonablative fractional lasers and more than a month for ablative lasers. But dermatitis may appear, as well as reactivation of acne, especially in patients who are having acne scars removed. There is also always the risk of infection and pigmentary alteration.”
Tip #3: Proper technique and close follow-up
The most expensive laser in the world still relies on good technique during deployment, she said. “I always stress, do not ‘pulse stack.’ Use side-by-side, nonoverlapping passes.”
Another key for success is to avoid using the laser on any tanned skin, or skin that will soon have sun exposure. “Any skin phototype with recent sun exposure has activated melanocytes and will have a higher tendency to develop postinflammatory hyperpigmentation. The cells are already activated and in the presence of any other damage – including a laser – they are programmed to produce more pigment.”
Individualize your treatment plan, she advised. “Do additional passes on the most severe areas, like cheek scars and perioral rhytides, and fewer passes and lower density on scar-prone areas, like the infraorbital area, mandible neck, and chest.”
Tip #4: Recognize and address complications
“Complications run the full spectrum from mild erythema to disseminated infections. I am always careful to figure out if it’s a true complication or an expected side effect. The greatest risk profiles are patients with darker skin phototypes, treatments in more sensitive areas, and patients with predisposing medical conditions like collagen or vascular diseases. You don’t need to avoid treating them, just be prepared for the higher risks.”
Dr. Alster also shared her techniques for managing some of the more common adverse events following a fractional laser procedure.
Prolonged erythema isn’t clinically serious, but it really bothers patients. They should be counseled to avoid putting any potentially irritating or allergenic product on their face, and that includes chemical sunscreens. A mineral sunscreen is a much better choice. “For management, postoperative cooling with ice packs is important. A mild topical corticosteroid and a nonsteroidal anti-inflammatory can help, too.”
Acne exacerbation is not uncommon, especially among patients being treated for acne scars. “In people who are prone to acne, I write a script for doxycycline. They don’t have to take it unless they break out. And I always avoid laser skin resurfacing in active acne.”
If a breakout does happen, stick to the well-trodden path, she advised. “We know how to treat acne. Discontinue any occlusive topical, start the patent on an antibiotic, treat topically with a clay masque to help dry things out.”
Infections can be alarming but are manageable when promptly treated. “The main thing is to diagnose and treat early. In those patients who are proven to have herpes simplex virus, I give an antiviral, like valacyclovir. I give 1 gram twice a day for a week, starting on the day of the procedure. I think a bigger question is, ‘Does everyone need a prophylactic antibiotic?’ There is probably no reason to start one routinely, and in fact, there is some evidence that if you do, you may get a more pathogenic organism if you do get an infection.”
Hyperpigmentation is always a concern. Dr Alster repeated her cardinal rule: Do not use the fractional laser on tanned skin or skin that will be getting sun exposure soon after the treatment, as melanocytes are already activated and ready to deposit pigment. Use strict posttreatment sun protection with a mineral sunscreen. While she is not “a big fan” of hydroquinone, Dr. Alster does employ other bleaching agents for postoperative hyperpigmentation, including alpha hydroxyl acid, retinoic acid, kojic acid, and lignin peroxidase.
Good technique and aftercare reduce the risk of hypertrophic scarring. This means avoiding excessive fluences and aggressive lasering techniques and early treatment of any suspected infection. “My main treatment is the 585nm pulsed dye laser, but the main thing is to avoid aggressive techniques with overlapping or stacking of pulses, strict wound care, and early treatment of any infections.”
Dr. Alster disclosed that she is a consultant to L’Oréal USA, an investigator for Revance Therapeutics and Sente Labs, and a medical advisor to Merz Aesthetics, and has investments/commercial interests in Home Skinovations.
SOURCE: Alster, T. et al, PREVENTION & MANAGEMENT OF
EXPERT ANALYSIS AT AAD 18
Dalbavancin proves highly effective in osteomyelitis
VIENNA – Two infusions of the long-acting lipoglycopeptide antibiotic dalbavancin showed a favorable clinical benefit for treatment of adult osteomyelitis in a phase II study.
Dalbavancin (Dalvance) showed positive results while avoiding the complexities of standard therapies that require longer, more frequent dosing, Urania Rappo, MD, said at the European Society of Clinical Microbiology and Infectious Diseases annual congress.
Dalbavancin already is approved for acute bacterial skin and skin structure infections, and its long terminal half-life of 14 days and high bone penetration made it a natural candidate for evaluation in the treatment of osteomyelitis, said Dr. Rappo, director of clinical development (anti-infectives) at Allergan, which markets the drug and sponsored the study.
Dalbavancin is a glycopeptide antibiotic with a lipid tail that prolongs its half-life, compared with other drugs in this category, such as vancomycin and teicoplanin, to which it is structurally related. It is highly potent against gram-positive bacterial infections, including methicillin-resistant Staphylococcus aureus.
The drug’s MIC90 for S. aureus is 0.06 mcg/mL; vancomycin’s, in comparison, is 1 mcg/mL. A 2015 bone penetration study found that the bone level 12 hours after a 1,000-mg infusion was 6.3 mcg/g. This remained elevated for 14 days; the concentration at 2 weeks was 4 mcg/g (Antimicrob Agents Chemother. 2015 Apr;59[4]:1849-55).
“The mean bone-to-plasma penetration ratio was 13%, and drug levels in bone were very similar to free drug levels in serum, so we expect that much of this is free drug in the bone, available for antimicrobial activity,” Dr. Rappo noted. “It’s not only long lasting, but highly potent, meaning we need less drug to kill the infecting organism.”
Dalbavancin was administered as two 1,500-mg IV infusions, 1 week apart in Dr. Rappo’s randomized, open-label, phase II study – the first clinical trial to examine the drug’s effect in osteomyelitis in adults. The study is ongoing; she presented interim results on 68 patients, 59 of whom took dalbavancin. The nine patients in the standard-of-care arm were treated according to the investigator’s clinical judgment. Vancomycin was the most commonly employed therapy. Three patients received vancomycin infusions for 4 weeks. Four received a regimen of 4-16 days of intravenous vancomycin followed by intravenous linezolid or levofloxacin to complete a 4- to 6-week course of therapy. Adjunctive aztreonam was permitted for presumed coinfection with a gram-negative pathogen and a switch to oral antibiotic for gram-negative coverage was allowed after clinical improvement.
The primary endpoint was clinical cure at 42 days in the clinically evaluable population, defined as recovery without need for further antibiotic therapy. Failure was defined as the need for additional antibiotics; more than 6 weeks of treatment in the comparator arm; new purulence; amputation due to infection progression; or death. Indeterminate response was defined as loss to follow-up or amputation due to vascular insufficiency.
There were several secondary endpoints: clinical improvement at day 21, including changes in C-reactive protein level and clinical response in patients who had follow-up at days 42, 180, and 365.
In the dalbavancin arm, patients had a mean age of 51 years. All had undergone surgical debridement and bone culture. The most common site of infection was the foot or leg (about 83%). The baseline mean CRP level was 41.8 mg/L. About half of the patients had methicillin-susceptible S. aureus on bone culture. Coagulase-negative staphylococci were present in 20%. About 22% had gram-negative pathogens, mostly present in a mixed infection along with gram-positive pathogens. Five patients (three on dalbavancin, two on standard of care) discontinued the study drug early because they were solely infected with gram-negative pathogens.
At day 42, clinical cure was seen in all the dalbavancin patients and six of the standard treatment patients. In the group with treatment data out to 180 days (54 on dalbavancin and 5 on standard therapy), clinical cure rates were similar.
At 180 days, clinical cure continued in 93% of the dalbavancin patients (50 of 54). Two patients were defined as failures, and two patients were indeterminate because of loss to follow-up. In the standard therapy group at 180 days, four of five standard therapy patients maintained clinical cure; none of these patients has reached the 365-day outcome.
There were no treatment-emergent adverse events (TEAEs) in the standard therapy group. In the dalbavancin group, 10 patients experienced TEAEs, only one of whom had TEAEs related to the study drug, which were not serious, Dr. Rappo said.
This study was performed at a single center in the Ukraine, and an additional phase II study in the United States has begun, she added.
msullivan@frontlinemedcom.com
On Twitter @alz_gal
VIENNA – Two infusions of the long-acting lipoglycopeptide antibiotic dalbavancin showed a favorable clinical benefit for treatment of adult osteomyelitis in a phase II study.
Dalbavancin (Dalvance) showed positive results while avoiding the complexities of standard therapies that require longer, more frequent dosing, Urania Rappo, MD, said at the European Society of Clinical Microbiology and Infectious Diseases annual congress.
Dalbavancin already is approved for acute bacterial skin and skin structure infections, and its long terminal half-life of 14 days and high bone penetration made it a natural candidate for evaluation in the treatment of osteomyelitis, said Dr. Rappo, director of clinical development (anti-infectives) at Allergan, which markets the drug and sponsored the study.
Dalbavancin is a glycopeptide antibiotic with a lipid tail that prolongs its half-life, compared with other drugs in this category, such as vancomycin and teicoplanin, to which it is structurally related. It is highly potent against gram-positive bacterial infections, including methicillin-resistant Staphylococcus aureus.
The drug’s MIC90 for S. aureus is 0.06 mcg/mL; vancomycin’s, in comparison, is 1 mcg/mL. A 2015 bone penetration study found that the bone level 12 hours after a 1,000-mg infusion was 6.3 mcg/g. This remained elevated for 14 days; the concentration at 2 weeks was 4 mcg/g (Antimicrob Agents Chemother. 2015 Apr;59[4]:1849-55).
“The mean bone-to-plasma penetration ratio was 13%, and drug levels in bone were very similar to free drug levels in serum, so we expect that much of this is free drug in the bone, available for antimicrobial activity,” Dr. Rappo noted. “It’s not only long lasting, but highly potent, meaning we need less drug to kill the infecting organism.”
Dalbavancin was administered as two 1,500-mg IV infusions, 1 week apart in Dr. Rappo’s randomized, open-label, phase II study – the first clinical trial to examine the drug’s effect in osteomyelitis in adults. The study is ongoing; she presented interim results on 68 patients, 59 of whom took dalbavancin. The nine patients in the standard-of-care arm were treated according to the investigator’s clinical judgment. Vancomycin was the most commonly employed therapy. Three patients received vancomycin infusions for 4 weeks. Four received a regimen of 4-16 days of intravenous vancomycin followed by intravenous linezolid or levofloxacin to complete a 4- to 6-week course of therapy. Adjunctive aztreonam was permitted for presumed coinfection with a gram-negative pathogen and a switch to oral antibiotic for gram-negative coverage was allowed after clinical improvement.
The primary endpoint was clinical cure at 42 days in the clinically evaluable population, defined as recovery without need for further antibiotic therapy. Failure was defined as the need for additional antibiotics; more than 6 weeks of treatment in the comparator arm; new purulence; amputation due to infection progression; or death. Indeterminate response was defined as loss to follow-up or amputation due to vascular insufficiency.
There were several secondary endpoints: clinical improvement at day 21, including changes in C-reactive protein level and clinical response in patients who had follow-up at days 42, 180, and 365.
In the dalbavancin arm, patients had a mean age of 51 years. All had undergone surgical debridement and bone culture. The most common site of infection was the foot or leg (about 83%). The baseline mean CRP level was 41.8 mg/L. About half of the patients had methicillin-susceptible S. aureus on bone culture. Coagulase-negative staphylococci were present in 20%. About 22% had gram-negative pathogens, mostly present in a mixed infection along with gram-positive pathogens. Five patients (three on dalbavancin, two on standard of care) discontinued the study drug early because they were solely infected with gram-negative pathogens.
At day 42, clinical cure was seen in all the dalbavancin patients and six of the standard treatment patients. In the group with treatment data out to 180 days (54 on dalbavancin and 5 on standard therapy), clinical cure rates were similar.
At 180 days, clinical cure continued in 93% of the dalbavancin patients (50 of 54). Two patients were defined as failures, and two patients were indeterminate because of loss to follow-up. In the standard therapy group at 180 days, four of five standard therapy patients maintained clinical cure; none of these patients has reached the 365-day outcome.
There were no treatment-emergent adverse events (TEAEs) in the standard therapy group. In the dalbavancin group, 10 patients experienced TEAEs, only one of whom had TEAEs related to the study drug, which were not serious, Dr. Rappo said.
This study was performed at a single center in the Ukraine, and an additional phase II study in the United States has begun, she added.
msullivan@frontlinemedcom.com
On Twitter @alz_gal
VIENNA – Two infusions of the long-acting lipoglycopeptide antibiotic dalbavancin showed a favorable clinical benefit for treatment of adult osteomyelitis in a phase II study.
Dalbavancin (Dalvance) showed positive results while avoiding the complexities of standard therapies that require longer, more frequent dosing, Urania Rappo, MD, said at the European Society of Clinical Microbiology and Infectious Diseases annual congress.
Dalbavancin already is approved for acute bacterial skin and skin structure infections, and its long terminal half-life of 14 days and high bone penetration made it a natural candidate for evaluation in the treatment of osteomyelitis, said Dr. Rappo, director of clinical development (anti-infectives) at Allergan, which markets the drug and sponsored the study.
Dalbavancin is a glycopeptide antibiotic with a lipid tail that prolongs its half-life, compared with other drugs in this category, such as vancomycin and teicoplanin, to which it is structurally related. It is highly potent against gram-positive bacterial infections, including methicillin-resistant Staphylococcus aureus.
The drug’s MIC90 for S. aureus is 0.06 mcg/mL; vancomycin’s, in comparison, is 1 mcg/mL. A 2015 bone penetration study found that the bone level 12 hours after a 1,000-mg infusion was 6.3 mcg/g. This remained elevated for 14 days; the concentration at 2 weeks was 4 mcg/g (Antimicrob Agents Chemother. 2015 Apr;59[4]:1849-55).
“The mean bone-to-plasma penetration ratio was 13%, and drug levels in bone were very similar to free drug levels in serum, so we expect that much of this is free drug in the bone, available for antimicrobial activity,” Dr. Rappo noted. “It’s not only long lasting, but highly potent, meaning we need less drug to kill the infecting organism.”
Dalbavancin was administered as two 1,500-mg IV infusions, 1 week apart in Dr. Rappo’s randomized, open-label, phase II study – the first clinical trial to examine the drug’s effect in osteomyelitis in adults. The study is ongoing; she presented interim results on 68 patients, 59 of whom took dalbavancin. The nine patients in the standard-of-care arm were treated according to the investigator’s clinical judgment. Vancomycin was the most commonly employed therapy. Three patients received vancomycin infusions for 4 weeks. Four received a regimen of 4-16 days of intravenous vancomycin followed by intravenous linezolid or levofloxacin to complete a 4- to 6-week course of therapy. Adjunctive aztreonam was permitted for presumed coinfection with a gram-negative pathogen and a switch to oral antibiotic for gram-negative coverage was allowed after clinical improvement.
The primary endpoint was clinical cure at 42 days in the clinically evaluable population, defined as recovery without need for further antibiotic therapy. Failure was defined as the need for additional antibiotics; more than 6 weeks of treatment in the comparator arm; new purulence; amputation due to infection progression; or death. Indeterminate response was defined as loss to follow-up or amputation due to vascular insufficiency.
There were several secondary endpoints: clinical improvement at day 21, including changes in C-reactive protein level and clinical response in patients who had follow-up at days 42, 180, and 365.
In the dalbavancin arm, patients had a mean age of 51 years. All had undergone surgical debridement and bone culture. The most common site of infection was the foot or leg (about 83%). The baseline mean CRP level was 41.8 mg/L. About half of the patients had methicillin-susceptible S. aureus on bone culture. Coagulase-negative staphylococci were present in 20%. About 22% had gram-negative pathogens, mostly present in a mixed infection along with gram-positive pathogens. Five patients (three on dalbavancin, two on standard of care) discontinued the study drug early because they were solely infected with gram-negative pathogens.
At day 42, clinical cure was seen in all the dalbavancin patients and six of the standard treatment patients. In the group with treatment data out to 180 days (54 on dalbavancin and 5 on standard therapy), clinical cure rates were similar.
At 180 days, clinical cure continued in 93% of the dalbavancin patients (50 of 54). Two patients were defined as failures, and two patients were indeterminate because of loss to follow-up. In the standard therapy group at 180 days, four of five standard therapy patients maintained clinical cure; none of these patients has reached the 365-day outcome.
There were no treatment-emergent adverse events (TEAEs) in the standard therapy group. In the dalbavancin group, 10 patients experienced TEAEs, only one of whom had TEAEs related to the study drug, which were not serious, Dr. Rappo said.
This study was performed at a single center in the Ukraine, and an additional phase II study in the United States has begun, she added.
msullivan@frontlinemedcom.com
On Twitter @alz_gal
Key clinical point:
Major finding: At 42 days, 100% of patients taking the drug were clear of infection.
Data source: A phase II trial involving 68 patients, 59 of whom were randomized to the study drug; the remainder were on standard treatment.
Disclosures: Allergan sponsored the study; Dr. Rappo is a company employee.
Omalizumab effects rapid, often complete, clearance of refractory bullous pemphigoid
ORLANDO – Omalizumab, a monoclonal anti-IgE antibody, may be a good option for patients with treatment-refractory bullous pemphigoid.
Patients who received omalizumab (Xolair) experienced rapid improvements, with 30%-50% lesion clearance within a week and complete clearance by 3 weeks, Kenneth Yu, MD, said at the annual meeting of the American Academy of Dermatology. With regular injections, they were kept symptom free for months. Some patients did flare, but were then easily controlled on standard treatment. Omalizumab, approved by the Food and Drug Administration in 2003, is indicated for moderate to severe persistent asthma and chronic idiopathic urticaria.
“We have now treated six patients with omalizumab with very good results with five of them. These are not your garden-variety BP patients, but people with very treatment-resistant disease who have failed treatment with corticosteroids alone, and in combination with other immunosuppressants.”
The rapid clinical improvements, along with observations that eosinophilia decreased with treatment, “strengthen the evidence that BP is an IgE-mediated, organ-specific autoimmune disease,” said Dr. Yu, senior resident in dermatology at the University of Michigan, Ann Arbor.
“Would I use this as a first-line treatment for BP? Probably not. But if you are seeing someone who’s nonresponsive to therapy, you might want to check IgE and eosinophil levels and if those are elevated, you might consider omalizumab as an adjunct treatment – and you might observe a fairly dramatic response.”
Three of Dr. Yu’s patients received omalizumab as monotherapy, and three received it in conjunction with other immunosuppressants. He described their disease presentation, treatment, and progression.
In general, Dr. Yu reserves omalizumab for patients with refractory disease and two particular clinical characteristics: high eosinophil count and elevated serum IgE. The initial dosing is based on the asthma treatment nomogram for the drug; he titrates it according to clinical response. “We don’t alter the total dose given, but we do adjust the frequency with which we give it.”
His first patient was a 70-year-old woman with a 1-year history of poorly controlled BP; she had failed prednisone, azathioprine, and minocycline. She also had a history of steroid-related vertebral compression fractures. She presented with an eosinophil count of over 400 cells/microL.
“We treated her with subcutaneous injections of 300 mg every 2 weeks for 16 weeks,” Dr. Yu said. Within 1 week, she had a 44% reduction in blisters; within 4 weeks, she had gone from 50% body surface area involvement to 5%.
After eight injections, the patient was disease free and Dr. Yu discontinued treatment. She remained clear until week 32 after treatment initiation; she had a flare manifested by increased pruritus and recurrence of lesions. Dr. Yu restarted omalizumab and the lesions cleared within 2 weeks. From weeks 35-72, the patient received five more injections and remained disease free.
“After that, she did have another flare, so we used omalizumab again,” but without the same excellent results. “She had an initial decrease in pruritus, and symptom improvement, but her disease subsequently worsened. We restarted her on prednisone and azathioprine and she has done well.”
Dr. Yu said he made “a couple of interesting observations on this case.”
“We saw no real correlation between disease activity score, and the levels of serum IgG antibodies. But we did notice a parallel correlation with the level of eosinophil and disease severity and also treatment response,” he said. “It was quite clear that immediately after injection, she had a dramatic drop in eosinophils” from 1,600 to 60 cells/microL within 24 hours.
His next case was a 72-year-old woman with a history of somewhat controlled essential tremor, and 6 months of highly pruritic BP blistering. She had been treated with 60 mg/day prednisone, but didn’t tolerate it well, developing steroid-induced psychosis with agitation and violence, and a worsening of her tremor. The steroid was tapered to 40 mg/day and azathioprine was added, but she was did not respond to this change and continued to develop new blisters each day. She was admitted to the hospital for plasmapheresis, which was not helpful. Nor did she respond to six cycles of cyclophosphamide.
At that point, Dr. Yu drew IgE and eosinophil levels: Her absolute eosinophil count was 1,600 cells/microL and IgE was 287 units/mL. He then gave the patient 300 mg omalizumab subcutaneously.
“Ten days after a single injection, her blisters had almost completely resolved,” he said. “To briefly describe her disease course, the blisters went away, and she had resolution of her pruritus. She was discharged with 1 month of prednisone, but we tapered that and have been able to maintain her on omalizumab alone. She had one mild flare, which was readily controlled with prednisone. The last time we saw her, she was disease free.”
He also described four other steroid-refractory BP patients treated with omalizumab.“Their commonalities were that they all had steroid-refractory disease that was resistant to immunosuppressants, had a high level of IgE, and most of them also had eosinophilia.”
Dr. Yu’s descriptions:
• A 78-year-old woman with refractory BP of 1.5 years responded well to three initial injections spaced 6 and 4 weeks apart, and has been well maintained for 20 months with 300-mL injections administered once a month. One relapse was easily controlled.
• A 72-year-old woman with 3.5 years of refractory BP responded well to 375 mg injections every 4 weeks and has been symptom free for a year on that maintenance dose.
• A 55-year-old woman with a 7-month history of refractory BP experienced a 30% reduction in body surface area blistering within 1 week of her first 375-mg injection. By 3 weeks, she was clear. She had three injections, 2 weeks apart, and was disease free for 3 months.
• An 86-year-old woman with longstanding refractory BP experienced a 22% reduction in blister count within a week of her first 375-mL injection. After a series of injections every 2 weeks, however, she developed an exacerbation of her preexisting chronic obstructive pulmonary disease, which was due primarily to tapering her prednisone. However, she no longer uses omalizumab.
“It is difficult to make recommendations because of the limitations of our data,” Dr. Yu said. “But based on the small number of patients we have treated, I would consider using omalizumab in patients with resistant disease who have an elevated IgE and eosinophil count. The optimal dosing regimen is not yet determined. Our approach is to start out with the asthma dosing and titrate until we see improvement. We use the highest dose indicated for the patient’s weight and IgE levels, typically 300-375 mg subcutaneously every 2-8 weeks, and start tapering when the patient gets control.”
He had no financial disclosures.
msullivan@frontlinemedcom.com
On Twitter @Alz_Gal
ORLANDO – Omalizumab, a monoclonal anti-IgE antibody, may be a good option for patients with treatment-refractory bullous pemphigoid.
Patients who received omalizumab (Xolair) experienced rapid improvements, with 30%-50% lesion clearance within a week and complete clearance by 3 weeks, Kenneth Yu, MD, said at the annual meeting of the American Academy of Dermatology. With regular injections, they were kept symptom free for months. Some patients did flare, but were then easily controlled on standard treatment. Omalizumab, approved by the Food and Drug Administration in 2003, is indicated for moderate to severe persistent asthma and chronic idiopathic urticaria.
“We have now treated six patients with omalizumab with very good results with five of them. These are not your garden-variety BP patients, but people with very treatment-resistant disease who have failed treatment with corticosteroids alone, and in combination with other immunosuppressants.”
The rapid clinical improvements, along with observations that eosinophilia decreased with treatment, “strengthen the evidence that BP is an IgE-mediated, organ-specific autoimmune disease,” said Dr. Yu, senior resident in dermatology at the University of Michigan, Ann Arbor.
“Would I use this as a first-line treatment for BP? Probably not. But if you are seeing someone who’s nonresponsive to therapy, you might want to check IgE and eosinophil levels and if those are elevated, you might consider omalizumab as an adjunct treatment – and you might observe a fairly dramatic response.”
Three of Dr. Yu’s patients received omalizumab as monotherapy, and three received it in conjunction with other immunosuppressants. He described their disease presentation, treatment, and progression.
In general, Dr. Yu reserves omalizumab for patients with refractory disease and two particular clinical characteristics: high eosinophil count and elevated serum IgE. The initial dosing is based on the asthma treatment nomogram for the drug; he titrates it according to clinical response. “We don’t alter the total dose given, but we do adjust the frequency with which we give it.”
His first patient was a 70-year-old woman with a 1-year history of poorly controlled BP; she had failed prednisone, azathioprine, and minocycline. She also had a history of steroid-related vertebral compression fractures. She presented with an eosinophil count of over 400 cells/microL.
“We treated her with subcutaneous injections of 300 mg every 2 weeks for 16 weeks,” Dr. Yu said. Within 1 week, she had a 44% reduction in blisters; within 4 weeks, she had gone from 50% body surface area involvement to 5%.
After eight injections, the patient was disease free and Dr. Yu discontinued treatment. She remained clear until week 32 after treatment initiation; she had a flare manifested by increased pruritus and recurrence of lesions. Dr. Yu restarted omalizumab and the lesions cleared within 2 weeks. From weeks 35-72, the patient received five more injections and remained disease free.
“After that, she did have another flare, so we used omalizumab again,” but without the same excellent results. “She had an initial decrease in pruritus, and symptom improvement, but her disease subsequently worsened. We restarted her on prednisone and azathioprine and she has done well.”
Dr. Yu said he made “a couple of interesting observations on this case.”
“We saw no real correlation between disease activity score, and the levels of serum IgG antibodies. But we did notice a parallel correlation with the level of eosinophil and disease severity and also treatment response,” he said. “It was quite clear that immediately after injection, she had a dramatic drop in eosinophils” from 1,600 to 60 cells/microL within 24 hours.
His next case was a 72-year-old woman with a history of somewhat controlled essential tremor, and 6 months of highly pruritic BP blistering. She had been treated with 60 mg/day prednisone, but didn’t tolerate it well, developing steroid-induced psychosis with agitation and violence, and a worsening of her tremor. The steroid was tapered to 40 mg/day and azathioprine was added, but she was did not respond to this change and continued to develop new blisters each day. She was admitted to the hospital for plasmapheresis, which was not helpful. Nor did she respond to six cycles of cyclophosphamide.
At that point, Dr. Yu drew IgE and eosinophil levels: Her absolute eosinophil count was 1,600 cells/microL and IgE was 287 units/mL. He then gave the patient 300 mg omalizumab subcutaneously.
“Ten days after a single injection, her blisters had almost completely resolved,” he said. “To briefly describe her disease course, the blisters went away, and she had resolution of her pruritus. She was discharged with 1 month of prednisone, but we tapered that and have been able to maintain her on omalizumab alone. She had one mild flare, which was readily controlled with prednisone. The last time we saw her, she was disease free.”
He also described four other steroid-refractory BP patients treated with omalizumab.“Their commonalities were that they all had steroid-refractory disease that was resistant to immunosuppressants, had a high level of IgE, and most of them also had eosinophilia.”
Dr. Yu’s descriptions:
• A 78-year-old woman with refractory BP of 1.5 years responded well to three initial injections spaced 6 and 4 weeks apart, and has been well maintained for 20 months with 300-mL injections administered once a month. One relapse was easily controlled.
• A 72-year-old woman with 3.5 years of refractory BP responded well to 375 mg injections every 4 weeks and has been symptom free for a year on that maintenance dose.
• A 55-year-old woman with a 7-month history of refractory BP experienced a 30% reduction in body surface area blistering within 1 week of her first 375-mg injection. By 3 weeks, she was clear. She had three injections, 2 weeks apart, and was disease free for 3 months.
• An 86-year-old woman with longstanding refractory BP experienced a 22% reduction in blister count within a week of her first 375-mL injection. After a series of injections every 2 weeks, however, she developed an exacerbation of her preexisting chronic obstructive pulmonary disease, which was due primarily to tapering her prednisone. However, she no longer uses omalizumab.
“It is difficult to make recommendations because of the limitations of our data,” Dr. Yu said. “But based on the small number of patients we have treated, I would consider using omalizumab in patients with resistant disease who have an elevated IgE and eosinophil count. The optimal dosing regimen is not yet determined. Our approach is to start out with the asthma dosing and titrate until we see improvement. We use the highest dose indicated for the patient’s weight and IgE levels, typically 300-375 mg subcutaneously every 2-8 weeks, and start tapering when the patient gets control.”
He had no financial disclosures.
msullivan@frontlinemedcom.com
On Twitter @Alz_Gal
ORLANDO – Omalizumab, a monoclonal anti-IgE antibody, may be a good option for patients with treatment-refractory bullous pemphigoid.
Patients who received omalizumab (Xolair) experienced rapid improvements, with 30%-50% lesion clearance within a week and complete clearance by 3 weeks, Kenneth Yu, MD, said at the annual meeting of the American Academy of Dermatology. With regular injections, they were kept symptom free for months. Some patients did flare, but were then easily controlled on standard treatment. Omalizumab, approved by the Food and Drug Administration in 2003, is indicated for moderate to severe persistent asthma and chronic idiopathic urticaria.
“We have now treated six patients with omalizumab with very good results with five of them. These are not your garden-variety BP patients, but people with very treatment-resistant disease who have failed treatment with corticosteroids alone, and in combination with other immunosuppressants.”
The rapid clinical improvements, along with observations that eosinophilia decreased with treatment, “strengthen the evidence that BP is an IgE-mediated, organ-specific autoimmune disease,” said Dr. Yu, senior resident in dermatology at the University of Michigan, Ann Arbor.
“Would I use this as a first-line treatment for BP? Probably not. But if you are seeing someone who’s nonresponsive to therapy, you might want to check IgE and eosinophil levels and if those are elevated, you might consider omalizumab as an adjunct treatment – and you might observe a fairly dramatic response.”
Three of Dr. Yu’s patients received omalizumab as monotherapy, and three received it in conjunction with other immunosuppressants. He described their disease presentation, treatment, and progression.
In general, Dr. Yu reserves omalizumab for patients with refractory disease and two particular clinical characteristics: high eosinophil count and elevated serum IgE. The initial dosing is based on the asthma treatment nomogram for the drug; he titrates it according to clinical response. “We don’t alter the total dose given, but we do adjust the frequency with which we give it.”
His first patient was a 70-year-old woman with a 1-year history of poorly controlled BP; she had failed prednisone, azathioprine, and minocycline. She also had a history of steroid-related vertebral compression fractures. She presented with an eosinophil count of over 400 cells/microL.
“We treated her with subcutaneous injections of 300 mg every 2 weeks for 16 weeks,” Dr. Yu said. Within 1 week, she had a 44% reduction in blisters; within 4 weeks, she had gone from 50% body surface area involvement to 5%.
After eight injections, the patient was disease free and Dr. Yu discontinued treatment. She remained clear until week 32 after treatment initiation; she had a flare manifested by increased pruritus and recurrence of lesions. Dr. Yu restarted omalizumab and the lesions cleared within 2 weeks. From weeks 35-72, the patient received five more injections and remained disease free.
“After that, she did have another flare, so we used omalizumab again,” but without the same excellent results. “She had an initial decrease in pruritus, and symptom improvement, but her disease subsequently worsened. We restarted her on prednisone and azathioprine and she has done well.”
Dr. Yu said he made “a couple of interesting observations on this case.”
“We saw no real correlation between disease activity score, and the levels of serum IgG antibodies. But we did notice a parallel correlation with the level of eosinophil and disease severity and also treatment response,” he said. “It was quite clear that immediately after injection, she had a dramatic drop in eosinophils” from 1,600 to 60 cells/microL within 24 hours.
His next case was a 72-year-old woman with a history of somewhat controlled essential tremor, and 6 months of highly pruritic BP blistering. She had been treated with 60 mg/day prednisone, but didn’t tolerate it well, developing steroid-induced psychosis with agitation and violence, and a worsening of her tremor. The steroid was tapered to 40 mg/day and azathioprine was added, but she was did not respond to this change and continued to develop new blisters each day. She was admitted to the hospital for plasmapheresis, which was not helpful. Nor did she respond to six cycles of cyclophosphamide.
At that point, Dr. Yu drew IgE and eosinophil levels: Her absolute eosinophil count was 1,600 cells/microL and IgE was 287 units/mL. He then gave the patient 300 mg omalizumab subcutaneously.
“Ten days after a single injection, her blisters had almost completely resolved,” he said. “To briefly describe her disease course, the blisters went away, and she had resolution of her pruritus. She was discharged with 1 month of prednisone, but we tapered that and have been able to maintain her on omalizumab alone. She had one mild flare, which was readily controlled with prednisone. The last time we saw her, she was disease free.”
He also described four other steroid-refractory BP patients treated with omalizumab.“Their commonalities were that they all had steroid-refractory disease that was resistant to immunosuppressants, had a high level of IgE, and most of them also had eosinophilia.”
Dr. Yu’s descriptions:
• A 78-year-old woman with refractory BP of 1.5 years responded well to three initial injections spaced 6 and 4 weeks apart, and has been well maintained for 20 months with 300-mL injections administered once a month. One relapse was easily controlled.
• A 72-year-old woman with 3.5 years of refractory BP responded well to 375 mg injections every 4 weeks and has been symptom free for a year on that maintenance dose.
• A 55-year-old woman with a 7-month history of refractory BP experienced a 30% reduction in body surface area blistering within 1 week of her first 375-mg injection. By 3 weeks, she was clear. She had three injections, 2 weeks apart, and was disease free for 3 months.
• An 86-year-old woman with longstanding refractory BP experienced a 22% reduction in blister count within a week of her first 375-mL injection. After a series of injections every 2 weeks, however, she developed an exacerbation of her preexisting chronic obstructive pulmonary disease, which was due primarily to tapering her prednisone. However, she no longer uses omalizumab.
“It is difficult to make recommendations because of the limitations of our data,” Dr. Yu said. “But based on the small number of patients we have treated, I would consider using omalizumab in patients with resistant disease who have an elevated IgE and eosinophil count. The optimal dosing regimen is not yet determined. Our approach is to start out with the asthma dosing and titrate until we see improvement. We use the highest dose indicated for the patient’s weight and IgE levels, typically 300-375 mg subcutaneously every 2-8 weeks, and start tapering when the patient gets control.”
He had no financial disclosures.
msullivan@frontlinemedcom.com
On Twitter @Alz_Gal
AT AAD 17
Lasers for Latino skin – A balance of gentleness and strength
ORLANDO – With its unique tendency to develop postinflammatory hyperpigmentation (PIH), Latino skin needs a gentle touch from powerful lasers, according to Eduardo Weiss, MD.
“It’s often best to use a lower power, even though you trade off some efficacy for safety,” said Dr. Weiss, a dermatologist in Miami. “In general, it’s better to go with less aggressive treatment and more sessions, than to risk getting too aggressive and having a bad outcome.”
Dr. Weiss stressed that there are no “one size fits all” recommendations about laser treatment in typical Latino skin, because there’s no such thing as typical Latino skin. The group comprises all Fitzpatrick phototypes. But, in general, he said, the darker the skin, the greater the chance of an acute laser-induced burn, postinflammatory hyperpigmentation, and scarring.
Although general skin tone can provide a good first guess about the potential for hyperreaction to lasers, Dr. Weiss bolsters his judgments with a very simple – but effective – screen: palmar and digital crease pigmentation. First suggested by Hector G. Leal-Silva, MD, of the Institute of Dermatology and Cosmetic Surgery, Monterrey, Mexico, the screen divides patients into four groups, depending on the concentration of pigment present in palmar creases. A score of 0 means no pigment is visible, and the risk of PIH is negligible; a score of 3 means the creases are highly pigmented, and that the risk of PIH is very high.
But, with some adjustments in delivery – including using longer wavelengths and pulse duration, lower fluence and density, and smaller spot sizes – lasers can be used safely and effectively in these at-risk patients, Dr. Weiss said.
Safe treatment starts with pretreatment. It’s best to avoid laser procedures during the summer, when skin is at its darkest. Dr. Weiss also recommends a 6-week regimen aimed at lightening the area to be treated. This can include:
- Sun avoidance and the regular use of a high SPF sunscreen.
- Hydroquinone 4%-8%.
- A “Miami peel,” which is a modified Jessner’s peel with kojic acid and hydroquinone.
- Kligman’s formula of hydroquinone, tretinoin, and a corticosteroid.
- Heliocare, an oral extract of the Polypodium leucotomos fern.
About a month before the procedure, he performs a test spot with the intended laser and its planned settings, in the preauricular area. Any PIH will be obvious within 2-4 weeks. He also carefully screens patients or any photosensitizing condition, like lupus or herpes simplex, or a history of any photosensitizing drugs, such as tetracycline.
Dr. Weiss made specific suggestions for laser treatment of some common Latino skin issues:
Pigmented lesions
The high density of epidermal melanin in Fitzpatrick types IV-VI acts as a competitive chromophore against hemoglobin and oxyhemoglobin. This makes it quite challenging to treat vascular lesions such as port wine stains and telangiectasias, he said. The pulsed dye laser is a good choice, with wavelengths of 585-590 nm especially effective. “The longer 595-nm wavelength allows for a slightly deeper penetration,” Dr. Weiss said. “However, the absorption coefficient of oxyhemoglobin is three times higher at 585 nm than [at] 590 nm.”
Longer pulses are generally safer in dark-skinned patients, he noted. “It will be much less effective than the 585, but for darker-skinned patients, we must sacrifice a little efficacy for safety.”
For rosacea and telangiectasias, Dr. Weiss suggests a 515-nm intense pulsed light with pulse duration of 12-15/ms for these lesions, or pigmentation, he also uses 540 nm or 500-600 nm with pulse duration of 12-15/ms.
Melasma, a very common condition in dark-skinned Latinos, is also “one of the most difficult and frustrating conditions to manage,” he pointed out. He turns to a laser only when the case is resistant to more conservative treatment, which typically includes Kligman’s formula, sunscreen, light peels, and azelaic or kojic acid.
“Lasers are still controversial and, in my opinion, a last resort for melasma. I wouldn’t start unless everything else fails. I reserve them for the deep nonresponding melasmas.”
The Q-switched Nd:YAG is the most widely used for melasma. The fluence used is less than 5 J/cm2, with a 6-mm spot size and a frequency of 10 Hz. The number of treatment sessions varies from 5 to 10 at 1-week intervals, Dr. Weiss said. “Keep in mind that rebound hyperpigmentation could be due to the multiple subthreshold exposures that can stimulate melanogenesis in some areas.”
Skin rejuvenation
Ablative lasers – long the gold standard for skin rejuvenation in those with light skin – can be problematic for darker-skinned patients, Dr. Weiss said.
“These lasers, like the CO2 and Erbium:YAG, can cause several unwanted side effects in Latino skin.” These can include hyperpigmentation, which occurs in 50% of Fitzpatrick III or higher phototypes; erythema that can last for months; and delayed-onset hypopigmentation.
“I think better options for our darker-skinned patients are nonablative infrared, microneedling, and radiofrequency devices,” Dr. Weiss said. “There are, however, newer microablative resurfacing lasers. Fractional CO2, fractional Erbium, and the 2,790-nm yttrium scandium gallium garnet, offer a safer modality with which to treat skin types IV and above. Compared with the older-generation resurfacing lasers, the microablative lasers minimize the amount and duration of erythema and edema, which can last just 3-4 days.”
Dr. Weiss had no relevant financial disclosures.
ORLANDO – With its unique tendency to develop postinflammatory hyperpigmentation (PIH), Latino skin needs a gentle touch from powerful lasers, according to Eduardo Weiss, MD.
“It’s often best to use a lower power, even though you trade off some efficacy for safety,” said Dr. Weiss, a dermatologist in Miami. “In general, it’s better to go with less aggressive treatment and more sessions, than to risk getting too aggressive and having a bad outcome.”
Dr. Weiss stressed that there are no “one size fits all” recommendations about laser treatment in typical Latino skin, because there’s no such thing as typical Latino skin. The group comprises all Fitzpatrick phototypes. But, in general, he said, the darker the skin, the greater the chance of an acute laser-induced burn, postinflammatory hyperpigmentation, and scarring.
Although general skin tone can provide a good first guess about the potential for hyperreaction to lasers, Dr. Weiss bolsters his judgments with a very simple – but effective – screen: palmar and digital crease pigmentation. First suggested by Hector G. Leal-Silva, MD, of the Institute of Dermatology and Cosmetic Surgery, Monterrey, Mexico, the screen divides patients into four groups, depending on the concentration of pigment present in palmar creases. A score of 0 means no pigment is visible, and the risk of PIH is negligible; a score of 3 means the creases are highly pigmented, and that the risk of PIH is very high.
But, with some adjustments in delivery – including using longer wavelengths and pulse duration, lower fluence and density, and smaller spot sizes – lasers can be used safely and effectively in these at-risk patients, Dr. Weiss said.
Safe treatment starts with pretreatment. It’s best to avoid laser procedures during the summer, when skin is at its darkest. Dr. Weiss also recommends a 6-week regimen aimed at lightening the area to be treated. This can include:
- Sun avoidance and the regular use of a high SPF sunscreen.
- Hydroquinone 4%-8%.
- A “Miami peel,” which is a modified Jessner’s peel with kojic acid and hydroquinone.
- Kligman’s formula of hydroquinone, tretinoin, and a corticosteroid.
- Heliocare, an oral extract of the Polypodium leucotomos fern.
About a month before the procedure, he performs a test spot with the intended laser and its planned settings, in the preauricular area. Any PIH will be obvious within 2-4 weeks. He also carefully screens patients or any photosensitizing condition, like lupus or herpes simplex, or a history of any photosensitizing drugs, such as tetracycline.
Dr. Weiss made specific suggestions for laser treatment of some common Latino skin issues:
Pigmented lesions
The high density of epidermal melanin in Fitzpatrick types IV-VI acts as a competitive chromophore against hemoglobin and oxyhemoglobin. This makes it quite challenging to treat vascular lesions such as port wine stains and telangiectasias, he said. The pulsed dye laser is a good choice, with wavelengths of 585-590 nm especially effective. “The longer 595-nm wavelength allows for a slightly deeper penetration,” Dr. Weiss said. “However, the absorption coefficient of oxyhemoglobin is three times higher at 585 nm than [at] 590 nm.”
Longer pulses are generally safer in dark-skinned patients, he noted. “It will be much less effective than the 585, but for darker-skinned patients, we must sacrifice a little efficacy for safety.”
For rosacea and telangiectasias, Dr. Weiss suggests a 515-nm intense pulsed light with pulse duration of 12-15/ms for these lesions, or pigmentation, he also uses 540 nm or 500-600 nm with pulse duration of 12-15/ms.
Melasma, a very common condition in dark-skinned Latinos, is also “one of the most difficult and frustrating conditions to manage,” he pointed out. He turns to a laser only when the case is resistant to more conservative treatment, which typically includes Kligman’s formula, sunscreen, light peels, and azelaic or kojic acid.
“Lasers are still controversial and, in my opinion, a last resort for melasma. I wouldn’t start unless everything else fails. I reserve them for the deep nonresponding melasmas.”
The Q-switched Nd:YAG is the most widely used for melasma. The fluence used is less than 5 J/cm2, with a 6-mm spot size and a frequency of 10 Hz. The number of treatment sessions varies from 5 to 10 at 1-week intervals, Dr. Weiss said. “Keep in mind that rebound hyperpigmentation could be due to the multiple subthreshold exposures that can stimulate melanogenesis in some areas.”
Skin rejuvenation
Ablative lasers – long the gold standard for skin rejuvenation in those with light skin – can be problematic for darker-skinned patients, Dr. Weiss said.
“These lasers, like the CO2 and Erbium:YAG, can cause several unwanted side effects in Latino skin.” These can include hyperpigmentation, which occurs in 50% of Fitzpatrick III or higher phototypes; erythema that can last for months; and delayed-onset hypopigmentation.
“I think better options for our darker-skinned patients are nonablative infrared, microneedling, and radiofrequency devices,” Dr. Weiss said. “There are, however, newer microablative resurfacing lasers. Fractional CO2, fractional Erbium, and the 2,790-nm yttrium scandium gallium garnet, offer a safer modality with which to treat skin types IV and above. Compared with the older-generation resurfacing lasers, the microablative lasers minimize the amount and duration of erythema and edema, which can last just 3-4 days.”
Dr. Weiss had no relevant financial disclosures.
ORLANDO – With its unique tendency to develop postinflammatory hyperpigmentation (PIH), Latino skin needs a gentle touch from powerful lasers, according to Eduardo Weiss, MD.
“It’s often best to use a lower power, even though you trade off some efficacy for safety,” said Dr. Weiss, a dermatologist in Miami. “In general, it’s better to go with less aggressive treatment and more sessions, than to risk getting too aggressive and having a bad outcome.”
Dr. Weiss stressed that there are no “one size fits all” recommendations about laser treatment in typical Latino skin, because there’s no such thing as typical Latino skin. The group comprises all Fitzpatrick phototypes. But, in general, he said, the darker the skin, the greater the chance of an acute laser-induced burn, postinflammatory hyperpigmentation, and scarring.
Although general skin tone can provide a good first guess about the potential for hyperreaction to lasers, Dr. Weiss bolsters his judgments with a very simple – but effective – screen: palmar and digital crease pigmentation. First suggested by Hector G. Leal-Silva, MD, of the Institute of Dermatology and Cosmetic Surgery, Monterrey, Mexico, the screen divides patients into four groups, depending on the concentration of pigment present in palmar creases. A score of 0 means no pigment is visible, and the risk of PIH is negligible; a score of 3 means the creases are highly pigmented, and that the risk of PIH is very high.
But, with some adjustments in delivery – including using longer wavelengths and pulse duration, lower fluence and density, and smaller spot sizes – lasers can be used safely and effectively in these at-risk patients, Dr. Weiss said.
Safe treatment starts with pretreatment. It’s best to avoid laser procedures during the summer, when skin is at its darkest. Dr. Weiss also recommends a 6-week regimen aimed at lightening the area to be treated. This can include:
- Sun avoidance and the regular use of a high SPF sunscreen.
- Hydroquinone 4%-8%.
- A “Miami peel,” which is a modified Jessner’s peel with kojic acid and hydroquinone.
- Kligman’s formula of hydroquinone, tretinoin, and a corticosteroid.
- Heliocare, an oral extract of the Polypodium leucotomos fern.
About a month before the procedure, he performs a test spot with the intended laser and its planned settings, in the preauricular area. Any PIH will be obvious within 2-4 weeks. He also carefully screens patients or any photosensitizing condition, like lupus or herpes simplex, or a history of any photosensitizing drugs, such as tetracycline.
Dr. Weiss made specific suggestions for laser treatment of some common Latino skin issues:
Pigmented lesions
The high density of epidermal melanin in Fitzpatrick types IV-VI acts as a competitive chromophore against hemoglobin and oxyhemoglobin. This makes it quite challenging to treat vascular lesions such as port wine stains and telangiectasias, he said. The pulsed dye laser is a good choice, with wavelengths of 585-590 nm especially effective. “The longer 595-nm wavelength allows for a slightly deeper penetration,” Dr. Weiss said. “However, the absorption coefficient of oxyhemoglobin is three times higher at 585 nm than [at] 590 nm.”
Longer pulses are generally safer in dark-skinned patients, he noted. “It will be much less effective than the 585, but for darker-skinned patients, we must sacrifice a little efficacy for safety.”
For rosacea and telangiectasias, Dr. Weiss suggests a 515-nm intense pulsed light with pulse duration of 12-15/ms for these lesions, or pigmentation, he also uses 540 nm or 500-600 nm with pulse duration of 12-15/ms.
Melasma, a very common condition in dark-skinned Latinos, is also “one of the most difficult and frustrating conditions to manage,” he pointed out. He turns to a laser only when the case is resistant to more conservative treatment, which typically includes Kligman’s formula, sunscreen, light peels, and azelaic or kojic acid.
“Lasers are still controversial and, in my opinion, a last resort for melasma. I wouldn’t start unless everything else fails. I reserve them for the deep nonresponding melasmas.”
The Q-switched Nd:YAG is the most widely used for melasma. The fluence used is less than 5 J/cm2, with a 6-mm spot size and a frequency of 10 Hz. The number of treatment sessions varies from 5 to 10 at 1-week intervals, Dr. Weiss said. “Keep in mind that rebound hyperpigmentation could be due to the multiple subthreshold exposures that can stimulate melanogenesis in some areas.”
Skin rejuvenation
Ablative lasers – long the gold standard for skin rejuvenation in those with light skin – can be problematic for darker-skinned patients, Dr. Weiss said.
“These lasers, like the CO2 and Erbium:YAG, can cause several unwanted side effects in Latino skin.” These can include hyperpigmentation, which occurs in 50% of Fitzpatrick III or higher phototypes; erythema that can last for months; and delayed-onset hypopigmentation.
“I think better options for our darker-skinned patients are nonablative infrared, microneedling, and radiofrequency devices,” Dr. Weiss said. “There are, however, newer microablative resurfacing lasers. Fractional CO2, fractional Erbium, and the 2,790-nm yttrium scandium gallium garnet, offer a safer modality with which to treat skin types IV and above. Compared with the older-generation resurfacing lasers, the microablative lasers minimize the amount and duration of erythema and edema, which can last just 3-4 days.”
Dr. Weiss had no relevant financial disclosures.
EXPERT ANALYSIS FROM AAD 17
Cerebrospinal fluid marker predicts brain atrophy
Baseline levels of visinin-like protein 1 in the cerebrospinal fluid were significant predictors of whole brain and regional brain atrophy, based on data from an observational study of 87 adults.
Cerebrospinal fluid visinin-like protein 1 (VILIP-1) has shown potential as a sign of neurodegeneration, said Dr. Rawan Tarawneh of Washington University, St. Louis. In this study, Dr. Tarawneh and her associates assessed the potential of VILIP-1 to predict rates of brain atrophy (JAMA Neurol. 2015 April 13 [doi:10.1001/jamaneurol.2015.0202]).
Overall, VILIP-1 predicted brain atrophy in AD patients as well as tau and p-tau181 levels. In addition, cognitively normal controls with VILIP-1, tau, or p-tau181 levels in the highest tercile had significantly higher rates of whole-brain, hippocampal, and entorhinal atrophy than those in the two lower terciles.
The study population comprised 23 community-dwelling adults with mild Alzheimer’s disease and 64 healthy controls who were part of a larger study on healthy aging and dementia; the mean age of the participants was 72 years, and 45% were women. Brain volume was assessed via magnetic resonance imaging.
“In our cohort, individuals with baseline VILIP-1, tau, or p-tau181 values in the upper tercile had higher rates of whole-brain and regional atrophy compared with individuals in the lower 2 terciles over time,” the researchers wrote.
Although the study results were limited by the small sample size and short follow-up period, the findings suggest that VILIP-1 may ultimately be used to monitor disease progression and evaluate responses to disease-modifying therapies, the researchers noted.
The study was funded in part by the National Institutes of Health, Eli Lilly, the JPB Foundation, Siemens Healthcare Diagnostics, and the Charles F. and Joanne Knight Alzheimer’s Disease Research Center. Dr. Tarawneh had no disclosures. Several coauthors disclosed ties with pharmaceutical and device companies, but not those involved in funding this study.
On Twitter @alz_gal
Baseline levels of visinin-like protein 1 in the cerebrospinal fluid were significant predictors of whole brain and regional brain atrophy, based on data from an observational study of 87 adults.
Cerebrospinal fluid visinin-like protein 1 (VILIP-1) has shown potential as a sign of neurodegeneration, said Dr. Rawan Tarawneh of Washington University, St. Louis. In this study, Dr. Tarawneh and her associates assessed the potential of VILIP-1 to predict rates of brain atrophy (JAMA Neurol. 2015 April 13 [doi:10.1001/jamaneurol.2015.0202]).
Overall, VILIP-1 predicted brain atrophy in AD patients as well as tau and p-tau181 levels. In addition, cognitively normal controls with VILIP-1, tau, or p-tau181 levels in the highest tercile had significantly higher rates of whole-brain, hippocampal, and entorhinal atrophy than those in the two lower terciles.
The study population comprised 23 community-dwelling adults with mild Alzheimer’s disease and 64 healthy controls who were part of a larger study on healthy aging and dementia; the mean age of the participants was 72 years, and 45% were women. Brain volume was assessed via magnetic resonance imaging.
“In our cohort, individuals with baseline VILIP-1, tau, or p-tau181 values in the upper tercile had higher rates of whole-brain and regional atrophy compared with individuals in the lower 2 terciles over time,” the researchers wrote.
Although the study results were limited by the small sample size and short follow-up period, the findings suggest that VILIP-1 may ultimately be used to monitor disease progression and evaluate responses to disease-modifying therapies, the researchers noted.
The study was funded in part by the National Institutes of Health, Eli Lilly, the JPB Foundation, Siemens Healthcare Diagnostics, and the Charles F. and Joanne Knight Alzheimer’s Disease Research Center. Dr. Tarawneh had no disclosures. Several coauthors disclosed ties with pharmaceutical and device companies, but not those involved in funding this study.
On Twitter @alz_gal
Baseline levels of visinin-like protein 1 in the cerebrospinal fluid were significant predictors of whole brain and regional brain atrophy, based on data from an observational study of 87 adults.
Cerebrospinal fluid visinin-like protein 1 (VILIP-1) has shown potential as a sign of neurodegeneration, said Dr. Rawan Tarawneh of Washington University, St. Louis. In this study, Dr. Tarawneh and her associates assessed the potential of VILIP-1 to predict rates of brain atrophy (JAMA Neurol. 2015 April 13 [doi:10.1001/jamaneurol.2015.0202]).
Overall, VILIP-1 predicted brain atrophy in AD patients as well as tau and p-tau181 levels. In addition, cognitively normal controls with VILIP-1, tau, or p-tau181 levels in the highest tercile had significantly higher rates of whole-brain, hippocampal, and entorhinal atrophy than those in the two lower terciles.
The study population comprised 23 community-dwelling adults with mild Alzheimer’s disease and 64 healthy controls who were part of a larger study on healthy aging and dementia; the mean age of the participants was 72 years, and 45% were women. Brain volume was assessed via magnetic resonance imaging.
“In our cohort, individuals with baseline VILIP-1, tau, or p-tau181 values in the upper tercile had higher rates of whole-brain and regional atrophy compared with individuals in the lower 2 terciles over time,” the researchers wrote.
Although the study results were limited by the small sample size and short follow-up period, the findings suggest that VILIP-1 may ultimately be used to monitor disease progression and evaluate responses to disease-modifying therapies, the researchers noted.
The study was funded in part by the National Institutes of Health, Eli Lilly, the JPB Foundation, Siemens Healthcare Diagnostics, and the Charles F. and Joanne Knight Alzheimer’s Disease Research Center. Dr. Tarawneh had no disclosures. Several coauthors disclosed ties with pharmaceutical and device companies, but not those involved in funding this study.
On Twitter @alz_gal
FROM JAMA NEUROLOGY
Key clinical point: Cerebrospinal fluid markers of neuronal loss may be useful in predicting progression in Alzheimer’s disease.
Major finding: Baseline cerebrospinal fluid levels of visinin-like protein 1 (VILIP-1) was a significant predictor of whole-brain, hippocampal, and entorhinal atrophy, as were tau and p-tau181.
Data source: An observational study of brain atrophy with an average follow-up of 2-3 years in 23 adults with mild AD and 64 controls with normal cognition.
Disclosures: The study was funded in part by the National Institutes of Health, Eli Lilly, the JPB Foundation, Siemens Healthcare Diagnostics, and the Charles F. and Joanne Knight Alzheimer’s Disease Research Center. Dr. Tarawneh had no disclosures. Several coauthors disclosed ties with pharmaceutical and device companies, but not those involved in funding this study.
VIDEO: Many stroke patients may miss out on clot-retrieval options
NASHVILLE, TENN. – A 1 million–patient analysis of the Get With the Guidelines database found striking improvements in outcomes after ischemic stroke.
Despite the proven benefits of new-generation clot-retrieval devices, however, only about 2% of such stroke patients undergo endovascular therapy.
In a video interview at the International Stroke Conference, Dr. Bijoy Menon of the department of clinical neurosciences at the University of Calgary (Alta.), who presented the findings at the conference, discussed this apparent clinical paradox.
The video associated with this article is no longer available on this site. Please view all of our videos on the MDedge YouTube channel
Dr. Menon’s study echoes findings of the landmark Endovascular Treatment for Small Core and Proximal Occlusion Ischemic Stroke (ESCAPE) trial, which found dramatically improved stroke outcomes after endovascular therapy.
But the benefits of such treatment should never outweigh the need for thoroughly screening patients and carefully considering their recovery prospects, Dr. Michael Hill, professor of neurology at the University of Calgary and primary investigator on the ESCAPE study, cautioned in another video interview at the meeting.
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 @alz_gal
NASHVILLE, TENN. – A 1 million–patient analysis of the Get With the Guidelines database found striking improvements in outcomes after ischemic stroke.
Despite the proven benefits of new-generation clot-retrieval devices, however, only about 2% of such stroke patients undergo endovascular therapy.
In a video interview at the International Stroke Conference, Dr. Bijoy Menon of the department of clinical neurosciences at the University of Calgary (Alta.), who presented the findings at the conference, discussed this apparent clinical paradox.
The video associated with this article is no longer available on this site. Please view all of our videos on the MDedge YouTube channel
Dr. Menon’s study echoes findings of the landmark Endovascular Treatment for Small Core and Proximal Occlusion Ischemic Stroke (ESCAPE) trial, which found dramatically improved stroke outcomes after endovascular therapy.
But the benefits of such treatment should never outweigh the need for thoroughly screening patients and carefully considering their recovery prospects, Dr. Michael Hill, professor of neurology at the University of Calgary and primary investigator on the ESCAPE study, cautioned in another video interview at the meeting.
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 @alz_gal
NASHVILLE, TENN. – A 1 million–patient analysis of the Get With the Guidelines database found striking improvements in outcomes after ischemic stroke.
Despite the proven benefits of new-generation clot-retrieval devices, however, only about 2% of such stroke patients undergo endovascular therapy.
In a video interview at the International Stroke Conference, Dr. Bijoy Menon of the department of clinical neurosciences at the University of Calgary (Alta.), who presented the findings at the conference, discussed this apparent clinical paradox.
The video associated with this article is no longer available on this site. Please view all of our videos on the MDedge YouTube channel
Dr. Menon’s study echoes findings of the landmark Endovascular Treatment for Small Core and Proximal Occlusion Ischemic Stroke (ESCAPE) trial, which found dramatically improved stroke outcomes after endovascular therapy.
But the benefits of such treatment should never outweigh the need for thoroughly screening patients and carefully considering their recovery prospects, Dr. Michael Hill, professor of neurology at the University of Calgary and primary investigator on the ESCAPE study, cautioned in another video interview at the meeting.
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 @alz_gal
AT THE INTERNATIONAL STROKE CONFERENCE
VIDEO: Is JNC 8’s hypertension treatment threshold too high?
NASHVILLE, TENN. – Last year, the Eighth Joint National Committee revised upward its classification of hypertension in healthy adults aged 60 years and older, recommending treatment when systolic pressure hits at least 150 mm Hg, or diastolic pressure reaches at least 90 mm Hg.
But raising the treatment cut point by 10 mm Hg from the earlier JNC 7 recommendations is a bad idea, Dr. Ralph L. Sacco warned at the International Stroke Conference – very bad, in fact.
And Dr. Sacco, the Olemberg Family Chair in Neurological Disorders at the University of Miami, said he has the data to prove it.
In a video interview at the meeting, Dr. Sacco outlined the findings from a new study exploring the stroke risks of patients who might find themselves now deemed normotensive under the JNC 8 hypertension guidelines.
On Twitter @alz_gal
NASHVILLE, TENN. – Last year, the Eighth Joint National Committee revised upward its classification of hypertension in healthy adults aged 60 years and older, recommending treatment when systolic pressure hits at least 150 mm Hg, or diastolic pressure reaches at least 90 mm Hg.
But raising the treatment cut point by 10 mm Hg from the earlier JNC 7 recommendations is a bad idea, Dr. Ralph L. Sacco warned at the International Stroke Conference – very bad, in fact.
And Dr. Sacco, the Olemberg Family Chair in Neurological Disorders at the University of Miami, said he has the data to prove it.
In a video interview at the meeting, Dr. Sacco outlined the findings from a new study exploring the stroke risks of patients who might find themselves now deemed normotensive under the JNC 8 hypertension guidelines.
On Twitter @alz_gal
NASHVILLE, TENN. – Last year, the Eighth Joint National Committee revised upward its classification of hypertension in healthy adults aged 60 years and older, recommending treatment when systolic pressure hits at least 150 mm Hg, or diastolic pressure reaches at least 90 mm Hg.
But raising the treatment cut point by 10 mm Hg from the earlier JNC 7 recommendations is a bad idea, Dr. Ralph L. Sacco warned at the International Stroke Conference – very bad, in fact.
And Dr. Sacco, the Olemberg Family Chair in Neurological Disorders at the University of Miami, said he has the data to prove it.
In a video interview at the meeting, Dr. Sacco outlined the findings from a new study exploring the stroke risks of patients who might find themselves now deemed normotensive under the JNC 8 hypertension guidelines.
On Twitter @alz_gal
AT THE INTERNATIONAL STROKE CONFERENCE
Delaying MMR, MMRV vaccines doubled febrile seizure risk
WASHINGTON – Delaying some early childhood vaccinations seems to double the risk that a child will experience a vaccine-related febrile seizure.
The finding is concerning as more and more parents ask about delaying or spacing out vaccines to avoid perceived harm from giving "too many [vaccines], too close together," Dr. Simon J. Hambidge said at the annual meeting of the Pediatric Academic Societies.
The observed risk in febrile seizures with vaccine delays may be explained physiologically by the child’s increased ability to mount a vigorous immune response. When children mount a better immune response, they’re more likely to have a fever. Further, febrile seizures begin to rise in toddlers between the ages of 16 and 23 months.
"It’s a complicated relationship. ... I think it’s clear that there is something going on at this time of life that’s increasing the risk of febrile seizures," said Dr. Hambidge, professor of pediatrics at the Colorado School of Public Health, Denver.
Dr. Hambidge examined the rate of vaccine-related febrile seizures in a cohort of 324,000 children who were born from 2004-2008. The study population was derived from eight large health care sites, all of which participate in the Vaccine Safety DataLink program. All children were seen in an emergency department or hospital for a febrile seizure at 93-730 days of age.
A self-controlled case series analysis accounted for associations between time (pre- and post vaccination) and exposure (vaccinated or not during the exposure windows). Based on known risks for fever after vaccination, the exposure risk window was set at 0-2 days after vaccination for inactive vaccines; the exposure risk window was 7-10 days afterward for live vaccines. The final measure was an incidence rate ratio (IRR).
The first analysis examined febrile seizures in the group that had infant vaccines administered according to the usual schedule. These included the DTaP (diphtheria, tetanus, and pertussis), conjugated pneumococcal, polio, coronavirus, Haemophilus influenzae type b, and rotavirus vaccines.
"There were no statistically significant differences in the IRR after any of these vaccines, whether they were given on time or delayed," Dr. Hambidge said. "I think this reflects the paucity of seizures generally seen during the first year of life."
For vaccines given during the second year of life, the IRR was examined for measles, mumps, rubella (MMR) and for measles, mumps, rubella, and varicella (MMRV) given on the usual schedule (12-15 months) and on a delayed schedule (16-23 months).
For babies who got the MMR on schedule, the IRR was 2.5, "corresponding to an attributable risk of about 1 [febrile seizure] in 4,000 doses," Dr. Hambidge said. When the MMR was delayed until the baby was 16-23 months old, the IRR significantly increased to 7.7 – an attributable risk of about 2 seizures per 4,000 doses.
A similar doubling of risk with the delayed schedule occurred with the MMRV vaccine, he said. Given at the normal schedule of 12-15 months, the IRR was 4.6, a risk of about one febrile seizure for every 2,000 vaccine doses. But when the MMRV was given at 16-23 months, the IRR rose to just above 15 – doubling the attributable risk to about 2 febrile seizures per 2,000 doses.
Parents should understand these risks but can be somewhat reassured that a febrile seizure isn’t generally a sign of something more sinister, Dr. Hambidge said in an interview.
"Kids with postvaccination febrile seizures have acute febrile seizures. None have gone on to develop epilepsy or have lasting problems. So the seizures are scary for parents, but typically result in a trip to the emergency department and then recovery. Still, it’s better to get the vaccines on time, rather than late, to minimize this risk," he said.
This study was funded through a subcontract with America’s Health Insurance Plans from the Centers for Disease Control and Prevention. Dr. Hambidge had no financial disclosures.
WASHINGTON – Delaying some early childhood vaccinations seems to double the risk that a child will experience a vaccine-related febrile seizure.
The finding is concerning as more and more parents ask about delaying or spacing out vaccines to avoid perceived harm from giving "too many [vaccines], too close together," Dr. Simon J. Hambidge said at the annual meeting of the Pediatric Academic Societies.
The observed risk in febrile seizures with vaccine delays may be explained physiologically by the child’s increased ability to mount a vigorous immune response. When children mount a better immune response, they’re more likely to have a fever. Further, febrile seizures begin to rise in toddlers between the ages of 16 and 23 months.
"It’s a complicated relationship. ... I think it’s clear that there is something going on at this time of life that’s increasing the risk of febrile seizures," said Dr. Hambidge, professor of pediatrics at the Colorado School of Public Health, Denver.
Dr. Hambidge examined the rate of vaccine-related febrile seizures in a cohort of 324,000 children who were born from 2004-2008. The study population was derived from eight large health care sites, all of which participate in the Vaccine Safety DataLink program. All children were seen in an emergency department or hospital for a febrile seizure at 93-730 days of age.
A self-controlled case series analysis accounted for associations between time (pre- and post vaccination) and exposure (vaccinated or not during the exposure windows). Based on known risks for fever after vaccination, the exposure risk window was set at 0-2 days after vaccination for inactive vaccines; the exposure risk window was 7-10 days afterward for live vaccines. The final measure was an incidence rate ratio (IRR).
The first analysis examined febrile seizures in the group that had infant vaccines administered according to the usual schedule. These included the DTaP (diphtheria, tetanus, and pertussis), conjugated pneumococcal, polio, coronavirus, Haemophilus influenzae type b, and rotavirus vaccines.
"There were no statistically significant differences in the IRR after any of these vaccines, whether they were given on time or delayed," Dr. Hambidge said. "I think this reflects the paucity of seizures generally seen during the first year of life."
For vaccines given during the second year of life, the IRR was examined for measles, mumps, rubella (MMR) and for measles, mumps, rubella, and varicella (MMRV) given on the usual schedule (12-15 months) and on a delayed schedule (16-23 months).
For babies who got the MMR on schedule, the IRR was 2.5, "corresponding to an attributable risk of about 1 [febrile seizure] in 4,000 doses," Dr. Hambidge said. When the MMR was delayed until the baby was 16-23 months old, the IRR significantly increased to 7.7 – an attributable risk of about 2 seizures per 4,000 doses.
A similar doubling of risk with the delayed schedule occurred with the MMRV vaccine, he said. Given at the normal schedule of 12-15 months, the IRR was 4.6, a risk of about one febrile seizure for every 2,000 vaccine doses. But when the MMRV was given at 16-23 months, the IRR rose to just above 15 – doubling the attributable risk to about 2 febrile seizures per 2,000 doses.
Parents should understand these risks but can be somewhat reassured that a febrile seizure isn’t generally a sign of something more sinister, Dr. Hambidge said in an interview.
"Kids with postvaccination febrile seizures have acute febrile seizures. None have gone on to develop epilepsy or have lasting problems. So the seizures are scary for parents, but typically result in a trip to the emergency department and then recovery. Still, it’s better to get the vaccines on time, rather than late, to minimize this risk," he said.
This study was funded through a subcontract with America’s Health Insurance Plans from the Centers for Disease Control and Prevention. Dr. Hambidge had no financial disclosures.
WASHINGTON – Delaying some early childhood vaccinations seems to double the risk that a child will experience a vaccine-related febrile seizure.
The finding is concerning as more and more parents ask about delaying or spacing out vaccines to avoid perceived harm from giving "too many [vaccines], too close together," Dr. Simon J. Hambidge said at the annual meeting of the Pediatric Academic Societies.
The observed risk in febrile seizures with vaccine delays may be explained physiologically by the child’s increased ability to mount a vigorous immune response. When children mount a better immune response, they’re more likely to have a fever. Further, febrile seizures begin to rise in toddlers between the ages of 16 and 23 months.
"It’s a complicated relationship. ... I think it’s clear that there is something going on at this time of life that’s increasing the risk of febrile seizures," said Dr. Hambidge, professor of pediatrics at the Colorado School of Public Health, Denver.
Dr. Hambidge examined the rate of vaccine-related febrile seizures in a cohort of 324,000 children who were born from 2004-2008. The study population was derived from eight large health care sites, all of which participate in the Vaccine Safety DataLink program. All children were seen in an emergency department or hospital for a febrile seizure at 93-730 days of age.
A self-controlled case series analysis accounted for associations between time (pre- and post vaccination) and exposure (vaccinated or not during the exposure windows). Based on known risks for fever after vaccination, the exposure risk window was set at 0-2 days after vaccination for inactive vaccines; the exposure risk window was 7-10 days afterward for live vaccines. The final measure was an incidence rate ratio (IRR).
The first analysis examined febrile seizures in the group that had infant vaccines administered according to the usual schedule. These included the DTaP (diphtheria, tetanus, and pertussis), conjugated pneumococcal, polio, coronavirus, Haemophilus influenzae type b, and rotavirus vaccines.
"There were no statistically significant differences in the IRR after any of these vaccines, whether they were given on time or delayed," Dr. Hambidge said. "I think this reflects the paucity of seizures generally seen during the first year of life."
For vaccines given during the second year of life, the IRR was examined for measles, mumps, rubella (MMR) and for measles, mumps, rubella, and varicella (MMRV) given on the usual schedule (12-15 months) and on a delayed schedule (16-23 months).
For babies who got the MMR on schedule, the IRR was 2.5, "corresponding to an attributable risk of about 1 [febrile seizure] in 4,000 doses," Dr. Hambidge said. When the MMR was delayed until the baby was 16-23 months old, the IRR significantly increased to 7.7 – an attributable risk of about 2 seizures per 4,000 doses.
A similar doubling of risk with the delayed schedule occurred with the MMRV vaccine, he said. Given at the normal schedule of 12-15 months, the IRR was 4.6, a risk of about one febrile seizure for every 2,000 vaccine doses. But when the MMRV was given at 16-23 months, the IRR rose to just above 15 – doubling the attributable risk to about 2 febrile seizures per 2,000 doses.
Parents should understand these risks but can be somewhat reassured that a febrile seizure isn’t generally a sign of something more sinister, Dr. Hambidge said in an interview.
"Kids with postvaccination febrile seizures have acute febrile seizures. None have gone on to develop epilepsy or have lasting problems. So the seizures are scary for parents, but typically result in a trip to the emergency department and then recovery. Still, it’s better to get the vaccines on time, rather than late, to minimize this risk," he said.
This study was funded through a subcontract with America’s Health Insurance Plans from the Centers for Disease Control and Prevention. Dr. Hambidge had no financial disclosures.
AT THE PAS ANNUAL MEETING
Major finding: When the MMRV vaccine was given at 16-23 months, the attributable risk of febrile seizures was about 2 per 2,000 doses.
Data source: Self-controlled case series analysis including 324,000 children.
Disclosures: This study was funded through a subcontract with America’s Health Insurance Plans from the Centers for Disease Control and Prevention. Dr. Hambidge had no financial declarations.
