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Doug Brunk is a San Diego-based award-winning reporter who began covering health care in 1991. Before joining the company, he wrote for the health sciences division of Columbia University and was an associate editor at Contemporary Long Term Care magazine when it won a Jesse H. Neal Award. His work has been syndicated by the Los Angeles Times and he is the author of two books related to the University of Kentucky Wildcats men's basketball program. Doug has a master’s degree in magazine journalism from the S.I. Newhouse School of Public Communications at Syracuse University. Follow him on Twitter @dougbrunk.
Pediatricians uniquely qualified to treat adolescents with opioid use disorder
NEW ORLEANS –
“One of the real benefits of treatment in primary care is that it removes the stigma so that these patients aren’t isolated into addiction clinics; they’re being treated by providers that they know well and that their family knows well,” Dr. Reynolds, a pediatrician who practices in Wareham, Mass., said at the annual meeting of the American Academy of Pediatrics. “That feels a lot better to them, and I think it makes a statement in the community that these people don’t need to be isolated. Anything we can do to reduce the stigma of opioid use disorder is important. We in primary care are well suited to manage chronic disease over the continuum.”
In 2016, the AAP released a policy statement advocating for pediatricians to consider providing medication-assisted treatment to patients with OUD (Pediatrics. 2016;138[3]e20161893). The statement cited results from a nationally representative sample of 345 addiction treatment programs serving adolescents and adults. It found that fewer than 50% of those programs used medication-assisted treatment (J Addict Med. 2011;5[1]:21-7). “When they looked at patients who actually had opioid dependence, the numbers were even lower,” said Dr. Reynolds, who was not involved with the study. “In fact, 34% of opioid-dependent patients received medication-assisted treatment. When they stratified it by age, the younger you were, the less likely you were to be treated. Only 11.5% of youth under 18 are actually being treated. We know that youth with opioid use disorders have very bad health outcomes over their lifetime. The fact that such few patients receive what is considered to be a gold-standard treatment is really alarming.”
Dr. Reynolds acknowledged that many perceived barriers exist to providing treatment of OUD in pediatric primary care, including the fact that patients with addiction are not easy to treat. “They can be manipulative and can make you feel both sad for them and angry at them within the same visit,” he said. “They also have complex needs. For many of these patients, it’s not just that they use opiates; they have medical problems and psychological diagnoses, and oftentimes they have social issues such as being in foster care. They also may have issues with their parents, employer, or their school, so there are many needs that need to be juggled. That can be overwhelming.”
However, he said that such patients “are actually in our wheelhouse, because as primary care physicians we’re used to coordinating care. These are the perfect patients to have a medical home. We manage chronic disease over the continuum of care. This is a chronic disease, and we have to help patients.”
Another perceived barrier for treating adolescents with OUD relates to reimbursement. While most patients with OUD have insurance, Dr. Reynolds finds that the requirement for prior authorizations can result in delay of treatment and poses an unnecessary burden on care providers. “It’s an administrative task that either the physician or the office staff has to take care of,” he said. “Interestingly, reimbursement ranks as a low concern in studies of buprenorphine providers. That tells me that this is not a major hurdle.”
Pediatricians also cite a lack of knowledge as a reason they’re leery of providing OUD treatment in their office. “They wonder: ‘How do I do this? What’s the right way to do it? Are there best practices?’ ” Dr. Reynolds said. “There’s a feeling that it must be dangerous, the idea that if I don’t do it right I’m going to hurt somebody. The reality is, buprenorphine is no more dangerous than any of the other opiates. Technically, because it’s a partial agonist, it’s probably less dangerous than some of the opiates that we prescribe. It’s no more dangerous than prescribing amitriptyline for chronic pain.”
One key resource, the Providers Clinical Support System (www.pcssnow.org), provides resources for clinicians and family members, education and training, and access to mentoring. Another resource, the American Society of Addiction Medicine (www.asam.org), includes clinical practice guidelines, online courses and training on the treatment of OUD, and sample consent and opioid-withdrawal forms. Dr. Reynolds characterized learning how to treat patients with OUD as no different than learning step therapy for asthma. “Once you look into it, you realize that there’s no sort of magic behind this,” he said. “It’s something that any of us can do. Staff can be trained. There are modules to train your staff into the protocols. Learn the knowledge and put it into action. Have the confidence and the knowledge.”
The Drug Addiction and Treatment Act of 2000 set up the waiver process by which physicians can obtain a waiver from the Drug Enforcement Agency after completing an 8-hour CME course on substance abuse disorder and buprenorphine prescribing. To receive a waiver to practice opioid dependency treatment with approved buprenorphine medications, a clinician must notify the SAMHSA Center for Substance Abuse Treatment of their intent to practice this form of medication-assisted treatment.
Dr. Reynolds acknowledged that not every practice is equipped to provide psychosocial support for complex patients with OUD. “When I first started this in 2017, I wanted to make sure that my patients were in some form of counseling,” he said. “However, the medical literature shows that you can treat OUD without counseling, and some of those patients will be fine, too. There have been reports that just going to Narcotics Anonymous meetings weekly has been shown to improve the effectiveness of medication-assisted treatment.”
For clinicians concerned about having backup when they face challenging cases, data shows that having more than one waivered provider in a practice is associated with completing waiver training. “This makes sense,” Dr. Reynolds said. “We like to be able to discuss our cases with colleagues, but a lot of us don’t want to be on call 365 days a year for our patients. Shared responsibility makes it easier. Access to specialty telemedicine consult has also been identified as a facilitator to physicians prescribing medical-assisted therapy.”
He concluded his presentation by noting that increasing numbers of OUD patients are initiating buprenorphine treatment in the ED. “That takes advantage of the fact that most of these patients present to the emergency room after receiving Narcan for an overdose,” Dr. Reynolds said. “In the emergency room, they’re counseled and instructed on how to start buprenorphine, they’re given the first dose, and they’re told to go home and avoid using any other opiates for 24 hours, start the buprenorphine, and follow up with their primary care doctor or an addiction medicine specialist in 3 days. In my community, this is what our local emergency department is doing for adult patients, except they’re not referring back to primary care. They’re referring to a hospital-based addiction medicine specialist. This is a way to increase access and get people started on buprenorphine treatment.”
Dr. Reynolds reported having no financial disclosures.
NEW ORLEANS –
“One of the real benefits of treatment in primary care is that it removes the stigma so that these patients aren’t isolated into addiction clinics; they’re being treated by providers that they know well and that their family knows well,” Dr. Reynolds, a pediatrician who practices in Wareham, Mass., said at the annual meeting of the American Academy of Pediatrics. “That feels a lot better to them, and I think it makes a statement in the community that these people don’t need to be isolated. Anything we can do to reduce the stigma of opioid use disorder is important. We in primary care are well suited to manage chronic disease over the continuum.”
In 2016, the AAP released a policy statement advocating for pediatricians to consider providing medication-assisted treatment to patients with OUD (Pediatrics. 2016;138[3]e20161893). The statement cited results from a nationally representative sample of 345 addiction treatment programs serving adolescents and adults. It found that fewer than 50% of those programs used medication-assisted treatment (J Addict Med. 2011;5[1]:21-7). “When they looked at patients who actually had opioid dependence, the numbers were even lower,” said Dr. Reynolds, who was not involved with the study. “In fact, 34% of opioid-dependent patients received medication-assisted treatment. When they stratified it by age, the younger you were, the less likely you were to be treated. Only 11.5% of youth under 18 are actually being treated. We know that youth with opioid use disorders have very bad health outcomes over their lifetime. The fact that such few patients receive what is considered to be a gold-standard treatment is really alarming.”
Dr. Reynolds acknowledged that many perceived barriers exist to providing treatment of OUD in pediatric primary care, including the fact that patients with addiction are not easy to treat. “They can be manipulative and can make you feel both sad for them and angry at them within the same visit,” he said. “They also have complex needs. For many of these patients, it’s not just that they use opiates; they have medical problems and psychological diagnoses, and oftentimes they have social issues such as being in foster care. They also may have issues with their parents, employer, or their school, so there are many needs that need to be juggled. That can be overwhelming.”
However, he said that such patients “are actually in our wheelhouse, because as primary care physicians we’re used to coordinating care. These are the perfect patients to have a medical home. We manage chronic disease over the continuum of care. This is a chronic disease, and we have to help patients.”
Another perceived barrier for treating adolescents with OUD relates to reimbursement. While most patients with OUD have insurance, Dr. Reynolds finds that the requirement for prior authorizations can result in delay of treatment and poses an unnecessary burden on care providers. “It’s an administrative task that either the physician or the office staff has to take care of,” he said. “Interestingly, reimbursement ranks as a low concern in studies of buprenorphine providers. That tells me that this is not a major hurdle.”
Pediatricians also cite a lack of knowledge as a reason they’re leery of providing OUD treatment in their office. “They wonder: ‘How do I do this? What’s the right way to do it? Are there best practices?’ ” Dr. Reynolds said. “There’s a feeling that it must be dangerous, the idea that if I don’t do it right I’m going to hurt somebody. The reality is, buprenorphine is no more dangerous than any of the other opiates. Technically, because it’s a partial agonist, it’s probably less dangerous than some of the opiates that we prescribe. It’s no more dangerous than prescribing amitriptyline for chronic pain.”
One key resource, the Providers Clinical Support System (www.pcssnow.org), provides resources for clinicians and family members, education and training, and access to mentoring. Another resource, the American Society of Addiction Medicine (www.asam.org), includes clinical practice guidelines, online courses and training on the treatment of OUD, and sample consent and opioid-withdrawal forms. Dr. Reynolds characterized learning how to treat patients with OUD as no different than learning step therapy for asthma. “Once you look into it, you realize that there’s no sort of magic behind this,” he said. “It’s something that any of us can do. Staff can be trained. There are modules to train your staff into the protocols. Learn the knowledge and put it into action. Have the confidence and the knowledge.”
The Drug Addiction and Treatment Act of 2000 set up the waiver process by which physicians can obtain a waiver from the Drug Enforcement Agency after completing an 8-hour CME course on substance abuse disorder and buprenorphine prescribing. To receive a waiver to practice opioid dependency treatment with approved buprenorphine medications, a clinician must notify the SAMHSA Center for Substance Abuse Treatment of their intent to practice this form of medication-assisted treatment.
Dr. Reynolds acknowledged that not every practice is equipped to provide psychosocial support for complex patients with OUD. “When I first started this in 2017, I wanted to make sure that my patients were in some form of counseling,” he said. “However, the medical literature shows that you can treat OUD without counseling, and some of those patients will be fine, too. There have been reports that just going to Narcotics Anonymous meetings weekly has been shown to improve the effectiveness of medication-assisted treatment.”
For clinicians concerned about having backup when they face challenging cases, data shows that having more than one waivered provider in a practice is associated with completing waiver training. “This makes sense,” Dr. Reynolds said. “We like to be able to discuss our cases with colleagues, but a lot of us don’t want to be on call 365 days a year for our patients. Shared responsibility makes it easier. Access to specialty telemedicine consult has also been identified as a facilitator to physicians prescribing medical-assisted therapy.”
He concluded his presentation by noting that increasing numbers of OUD patients are initiating buprenorphine treatment in the ED. “That takes advantage of the fact that most of these patients present to the emergency room after receiving Narcan for an overdose,” Dr. Reynolds said. “In the emergency room, they’re counseled and instructed on how to start buprenorphine, they’re given the first dose, and they’re told to go home and avoid using any other opiates for 24 hours, start the buprenorphine, and follow up with their primary care doctor or an addiction medicine specialist in 3 days. In my community, this is what our local emergency department is doing for adult patients, except they’re not referring back to primary care. They’re referring to a hospital-based addiction medicine specialist. This is a way to increase access and get people started on buprenorphine treatment.”
Dr. Reynolds reported having no financial disclosures.
NEW ORLEANS –
“One of the real benefits of treatment in primary care is that it removes the stigma so that these patients aren’t isolated into addiction clinics; they’re being treated by providers that they know well and that their family knows well,” Dr. Reynolds, a pediatrician who practices in Wareham, Mass., said at the annual meeting of the American Academy of Pediatrics. “That feels a lot better to them, and I think it makes a statement in the community that these people don’t need to be isolated. Anything we can do to reduce the stigma of opioid use disorder is important. We in primary care are well suited to manage chronic disease over the continuum.”
In 2016, the AAP released a policy statement advocating for pediatricians to consider providing medication-assisted treatment to patients with OUD (Pediatrics. 2016;138[3]e20161893). The statement cited results from a nationally representative sample of 345 addiction treatment programs serving adolescents and adults. It found that fewer than 50% of those programs used medication-assisted treatment (J Addict Med. 2011;5[1]:21-7). “When they looked at patients who actually had opioid dependence, the numbers were even lower,” said Dr. Reynolds, who was not involved with the study. “In fact, 34% of opioid-dependent patients received medication-assisted treatment. When they stratified it by age, the younger you were, the less likely you were to be treated. Only 11.5% of youth under 18 are actually being treated. We know that youth with opioid use disorders have very bad health outcomes over their lifetime. The fact that such few patients receive what is considered to be a gold-standard treatment is really alarming.”
Dr. Reynolds acknowledged that many perceived barriers exist to providing treatment of OUD in pediatric primary care, including the fact that patients with addiction are not easy to treat. “They can be manipulative and can make you feel both sad for them and angry at them within the same visit,” he said. “They also have complex needs. For many of these patients, it’s not just that they use opiates; they have medical problems and psychological diagnoses, and oftentimes they have social issues such as being in foster care. They also may have issues with their parents, employer, or their school, so there are many needs that need to be juggled. That can be overwhelming.”
However, he said that such patients “are actually in our wheelhouse, because as primary care physicians we’re used to coordinating care. These are the perfect patients to have a medical home. We manage chronic disease over the continuum of care. This is a chronic disease, and we have to help patients.”
Another perceived barrier for treating adolescents with OUD relates to reimbursement. While most patients with OUD have insurance, Dr. Reynolds finds that the requirement for prior authorizations can result in delay of treatment and poses an unnecessary burden on care providers. “It’s an administrative task that either the physician or the office staff has to take care of,” he said. “Interestingly, reimbursement ranks as a low concern in studies of buprenorphine providers. That tells me that this is not a major hurdle.”
Pediatricians also cite a lack of knowledge as a reason they’re leery of providing OUD treatment in their office. “They wonder: ‘How do I do this? What’s the right way to do it? Are there best practices?’ ” Dr. Reynolds said. “There’s a feeling that it must be dangerous, the idea that if I don’t do it right I’m going to hurt somebody. The reality is, buprenorphine is no more dangerous than any of the other opiates. Technically, because it’s a partial agonist, it’s probably less dangerous than some of the opiates that we prescribe. It’s no more dangerous than prescribing amitriptyline for chronic pain.”
One key resource, the Providers Clinical Support System (www.pcssnow.org), provides resources for clinicians and family members, education and training, and access to mentoring. Another resource, the American Society of Addiction Medicine (www.asam.org), includes clinical practice guidelines, online courses and training on the treatment of OUD, and sample consent and opioid-withdrawal forms. Dr. Reynolds characterized learning how to treat patients with OUD as no different than learning step therapy for asthma. “Once you look into it, you realize that there’s no sort of magic behind this,” he said. “It’s something that any of us can do. Staff can be trained. There are modules to train your staff into the protocols. Learn the knowledge and put it into action. Have the confidence and the knowledge.”
The Drug Addiction and Treatment Act of 2000 set up the waiver process by which physicians can obtain a waiver from the Drug Enforcement Agency after completing an 8-hour CME course on substance abuse disorder and buprenorphine prescribing. To receive a waiver to practice opioid dependency treatment with approved buprenorphine medications, a clinician must notify the SAMHSA Center for Substance Abuse Treatment of their intent to practice this form of medication-assisted treatment.
Dr. Reynolds acknowledged that not every practice is equipped to provide psychosocial support for complex patients with OUD. “When I first started this in 2017, I wanted to make sure that my patients were in some form of counseling,” he said. “However, the medical literature shows that you can treat OUD without counseling, and some of those patients will be fine, too. There have been reports that just going to Narcotics Anonymous meetings weekly has been shown to improve the effectiveness of medication-assisted treatment.”
For clinicians concerned about having backup when they face challenging cases, data shows that having more than one waivered provider in a practice is associated with completing waiver training. “This makes sense,” Dr. Reynolds said. “We like to be able to discuss our cases with colleagues, but a lot of us don’t want to be on call 365 days a year for our patients. Shared responsibility makes it easier. Access to specialty telemedicine consult has also been identified as a facilitator to physicians prescribing medical-assisted therapy.”
He concluded his presentation by noting that increasing numbers of OUD patients are initiating buprenorphine treatment in the ED. “That takes advantage of the fact that most of these patients present to the emergency room after receiving Narcan for an overdose,” Dr. Reynolds said. “In the emergency room, they’re counseled and instructed on how to start buprenorphine, they’re given the first dose, and they’re told to go home and avoid using any other opiates for 24 hours, start the buprenorphine, and follow up with their primary care doctor or an addiction medicine specialist in 3 days. In my community, this is what our local emergency department is doing for adult patients, except they’re not referring back to primary care. They’re referring to a hospital-based addiction medicine specialist. This is a way to increase access and get people started on buprenorphine treatment.”
Dr. Reynolds reported having no financial disclosures.
EXPERT ANALYSIS FROM AAP 19
Expert shares tips for TNF-alpha inhibitor use in special populations
LAS VEGAS – Francisco A. Kerdel, BSc, MBBS, said at the Skin Disease Education Foundation’s annual Las Vegas Dermatology Seminar.
Dr. Kerdel, professor and vice chair of the department of dermatology at Florida International University, Miami, noted that, while tumor necrosis factor (TNF)–alpha inhibitors are category B drugs, inadequate data exist regarding lactation and exposure throughout pregnancy. “Rates of malformations and spontaneous abortions with therapy are similar to those in the general population, higher concentrations of infliximab and adalimumab have been found in infant and cord blood, compared with certolizumab pegol,” an anti-TNF biologic, he said.
In a prospective, postmarketing, multicenter pharmacokinetic study, researchers found a lack of placental transfer of certolizumab pegol during pregnancy (Ann Rheum Dis. 2018;77:228-33). Specifically, certolizumab levels were below the lower limit of quantification (less than 0.032 mcg/mL) in 13 of 14 infant samples at birth and in all infant samples at weeks 4 and 8. Only one infant had a minimal certolizumab level at birth (infant/mother ratio of 0.0009). No antibodies were detected at any time point during the study. Safety data in mothers were in line with the known safety profile of certolizumab and pregnancy profile of these underlying diseases. Adverse events experienced by the infants did not show any patterns or clusters of events suggesting a specific safety signal in children.
In a separate postmarketing pharmacokinetic study, investigators evaluated the transfer of certolizumab into breast milk (Ann Rheum Dis. 2017;76:1890-6). They found that the average daily infant dose of certolizumab was minimal. Specifically, the highest concentration of certolizumab in breast milk (0.0758 mcg/mL) was less than 1% of the expected mean plasma trough concentration of a therapeutic dose.
How do TNF-alpha inhibitors fare in the pediatric population? In a retrospective study of 390 children with psoriasis treated at 20 centers in the United States, Canada, and Europe, researchers evaluated the safety of systemic agents (JAMA Dermatol. 2017;153[11]:1147-57). Most (69%) were prescribed methotrexate, followed by biologics, acitretin, cyclosporine, and fumaric acid. Drug discontinuation (because of adverse events), which is sometimes used as an efficacy parameter, occurred in 12% of those who were on methotrexate, compared with 3% of those on biologics, 67% of those on acitretin, and 68% of those on fumaric acid.
At the other end of the age spectrum, biologic therapy is generally effective and well tolerated in elderly patients. “Sometimes, they may be more effective than other traditional drugs,” Dr. Kerdel said. “We’re a little bit concerned about immunosenescence, which can increase the risk for severe infections and malignancies. And, 90% of elderly patients with psoriasis may have comorbidities that need to be taken into account when treating psoriasis.”
Other factors come into play when choosing the right anti-TNF agent, including weight. While clinical trials show efficacy across weight groups, infliximab has weight-based dosing, “which may make it a better choice,” Dr. Kerdel said. “Patients taking etanercept may need a biweekly dose.”
Treatment flexibility also comes into play. For example, stopping therapy because of an infection or surgery may be problematic in drugs with a long half-life. Then there’s the issue of patient preference. “Some people don’t want to be injected frequently,” he said. “Some people don’t want to be injected at all and may require a simpler dosing regimen.”
Optimizing anti-TNF-alpha treatment starts with recognizing that there is a loss of response over time, Dr. Kerdel said, “or there may not be a response at all.” Contributing factors may include immunogenicity, suboptimal dosing, and poor patient adherence. In order to optimize treatment, clinicians can try switching agents or combination therapy, and explore continuous versus intermittent dosing.
“We really don’t have good data on the best protocol for switching treatment after failure of an anti-TNF-alpha agent,” he added. In cases of primary and secondary treatment failure, there is no consensus or guidelines on which second-line agent to use, nor good data on which measures to use.
No evidence-based guidelines are available for screening and monitoring patients receiving biologic therapy for psoriasis, either. “Evidence is strongest [grade B] for tuberculosis screening in patients treated with biologic agents,” Dr. Kerdel said. “Among known hepatitis B virus carriers, consider monitoring liver function tests and viral load [grade C]. High-grade evidence is lacking to support other routine testing. Physicians should use clinical judgment when screening and monitoring patients.”
He concluded his presentation by noting that there are a number of biosimilar agents available or in the pipeline for infliximab, adalimumab, and etanercept. This raises a number of questions for current and future consideration. For one, “will biosimilars show the same long-term efficacy and safety as the innovator products?” he asked. “Real-world, postmarketing, and registry data are needed. Will biosimilar agents offer significant cost benefits? Will biosimilar labeling be adequately transparent? Will we find biomarkers to help us target biologic agents to specific patients and subtypes of psoriasis?”
Dr. Kerdel reported that he is a member of the speaker’s bureau for AbbVie, Amgen, Celgene, Janssen, Novartis, Lilly, Leo, Ortho, and Novartis. He has also received grant/research support from AbbVie, Amgen, AstraZeneca, Celgene, Janssen, Leo, Lilly, Menlo Therapeutics, Novartis, Pfizer, and XBiotech.
SDEF and this news organization are owned by the same parent company.
LAS VEGAS – Francisco A. Kerdel, BSc, MBBS, said at the Skin Disease Education Foundation’s annual Las Vegas Dermatology Seminar.
Dr. Kerdel, professor and vice chair of the department of dermatology at Florida International University, Miami, noted that, while tumor necrosis factor (TNF)–alpha inhibitors are category B drugs, inadequate data exist regarding lactation and exposure throughout pregnancy. “Rates of malformations and spontaneous abortions with therapy are similar to those in the general population, higher concentrations of infliximab and adalimumab have been found in infant and cord blood, compared with certolizumab pegol,” an anti-TNF biologic, he said.
In a prospective, postmarketing, multicenter pharmacokinetic study, researchers found a lack of placental transfer of certolizumab pegol during pregnancy (Ann Rheum Dis. 2018;77:228-33). Specifically, certolizumab levels were below the lower limit of quantification (less than 0.032 mcg/mL) in 13 of 14 infant samples at birth and in all infant samples at weeks 4 and 8. Only one infant had a minimal certolizumab level at birth (infant/mother ratio of 0.0009). No antibodies were detected at any time point during the study. Safety data in mothers were in line with the known safety profile of certolizumab and pregnancy profile of these underlying diseases. Adverse events experienced by the infants did not show any patterns or clusters of events suggesting a specific safety signal in children.
In a separate postmarketing pharmacokinetic study, investigators evaluated the transfer of certolizumab into breast milk (Ann Rheum Dis. 2017;76:1890-6). They found that the average daily infant dose of certolizumab was minimal. Specifically, the highest concentration of certolizumab in breast milk (0.0758 mcg/mL) was less than 1% of the expected mean plasma trough concentration of a therapeutic dose.
How do TNF-alpha inhibitors fare in the pediatric population? In a retrospective study of 390 children with psoriasis treated at 20 centers in the United States, Canada, and Europe, researchers evaluated the safety of systemic agents (JAMA Dermatol. 2017;153[11]:1147-57). Most (69%) were prescribed methotrexate, followed by biologics, acitretin, cyclosporine, and fumaric acid. Drug discontinuation (because of adverse events), which is sometimes used as an efficacy parameter, occurred in 12% of those who were on methotrexate, compared with 3% of those on biologics, 67% of those on acitretin, and 68% of those on fumaric acid.
At the other end of the age spectrum, biologic therapy is generally effective and well tolerated in elderly patients. “Sometimes, they may be more effective than other traditional drugs,” Dr. Kerdel said. “We’re a little bit concerned about immunosenescence, which can increase the risk for severe infections and malignancies. And, 90% of elderly patients with psoriasis may have comorbidities that need to be taken into account when treating psoriasis.”
Other factors come into play when choosing the right anti-TNF agent, including weight. While clinical trials show efficacy across weight groups, infliximab has weight-based dosing, “which may make it a better choice,” Dr. Kerdel said. “Patients taking etanercept may need a biweekly dose.”
Treatment flexibility also comes into play. For example, stopping therapy because of an infection or surgery may be problematic in drugs with a long half-life. Then there’s the issue of patient preference. “Some people don’t want to be injected frequently,” he said. “Some people don’t want to be injected at all and may require a simpler dosing regimen.”
Optimizing anti-TNF-alpha treatment starts with recognizing that there is a loss of response over time, Dr. Kerdel said, “or there may not be a response at all.” Contributing factors may include immunogenicity, suboptimal dosing, and poor patient adherence. In order to optimize treatment, clinicians can try switching agents or combination therapy, and explore continuous versus intermittent dosing.
“We really don’t have good data on the best protocol for switching treatment after failure of an anti-TNF-alpha agent,” he added. In cases of primary and secondary treatment failure, there is no consensus or guidelines on which second-line agent to use, nor good data on which measures to use.
No evidence-based guidelines are available for screening and monitoring patients receiving biologic therapy for psoriasis, either. “Evidence is strongest [grade B] for tuberculosis screening in patients treated with biologic agents,” Dr. Kerdel said. “Among known hepatitis B virus carriers, consider monitoring liver function tests and viral load [grade C]. High-grade evidence is lacking to support other routine testing. Physicians should use clinical judgment when screening and monitoring patients.”
He concluded his presentation by noting that there are a number of biosimilar agents available or in the pipeline for infliximab, adalimumab, and etanercept. This raises a number of questions for current and future consideration. For one, “will biosimilars show the same long-term efficacy and safety as the innovator products?” he asked. “Real-world, postmarketing, and registry data are needed. Will biosimilar agents offer significant cost benefits? Will biosimilar labeling be adequately transparent? Will we find biomarkers to help us target biologic agents to specific patients and subtypes of psoriasis?”
Dr. Kerdel reported that he is a member of the speaker’s bureau for AbbVie, Amgen, Celgene, Janssen, Novartis, Lilly, Leo, Ortho, and Novartis. He has also received grant/research support from AbbVie, Amgen, AstraZeneca, Celgene, Janssen, Leo, Lilly, Menlo Therapeutics, Novartis, Pfizer, and XBiotech.
SDEF and this news organization are owned by the same parent company.
LAS VEGAS – Francisco A. Kerdel, BSc, MBBS, said at the Skin Disease Education Foundation’s annual Las Vegas Dermatology Seminar.
Dr. Kerdel, professor and vice chair of the department of dermatology at Florida International University, Miami, noted that, while tumor necrosis factor (TNF)–alpha inhibitors are category B drugs, inadequate data exist regarding lactation and exposure throughout pregnancy. “Rates of malformations and spontaneous abortions with therapy are similar to those in the general population, higher concentrations of infliximab and adalimumab have been found in infant and cord blood, compared with certolizumab pegol,” an anti-TNF biologic, he said.
In a prospective, postmarketing, multicenter pharmacokinetic study, researchers found a lack of placental transfer of certolizumab pegol during pregnancy (Ann Rheum Dis. 2018;77:228-33). Specifically, certolizumab levels were below the lower limit of quantification (less than 0.032 mcg/mL) in 13 of 14 infant samples at birth and in all infant samples at weeks 4 and 8. Only one infant had a minimal certolizumab level at birth (infant/mother ratio of 0.0009). No antibodies were detected at any time point during the study. Safety data in mothers were in line with the known safety profile of certolizumab and pregnancy profile of these underlying diseases. Adverse events experienced by the infants did not show any patterns or clusters of events suggesting a specific safety signal in children.
In a separate postmarketing pharmacokinetic study, investigators evaluated the transfer of certolizumab into breast milk (Ann Rheum Dis. 2017;76:1890-6). They found that the average daily infant dose of certolizumab was minimal. Specifically, the highest concentration of certolizumab in breast milk (0.0758 mcg/mL) was less than 1% of the expected mean plasma trough concentration of a therapeutic dose.
How do TNF-alpha inhibitors fare in the pediatric population? In a retrospective study of 390 children with psoriasis treated at 20 centers in the United States, Canada, and Europe, researchers evaluated the safety of systemic agents (JAMA Dermatol. 2017;153[11]:1147-57). Most (69%) were prescribed methotrexate, followed by biologics, acitretin, cyclosporine, and fumaric acid. Drug discontinuation (because of adverse events), which is sometimes used as an efficacy parameter, occurred in 12% of those who were on methotrexate, compared with 3% of those on biologics, 67% of those on acitretin, and 68% of those on fumaric acid.
At the other end of the age spectrum, biologic therapy is generally effective and well tolerated in elderly patients. “Sometimes, they may be more effective than other traditional drugs,” Dr. Kerdel said. “We’re a little bit concerned about immunosenescence, which can increase the risk for severe infections and malignancies. And, 90% of elderly patients with psoriasis may have comorbidities that need to be taken into account when treating psoriasis.”
Other factors come into play when choosing the right anti-TNF agent, including weight. While clinical trials show efficacy across weight groups, infliximab has weight-based dosing, “which may make it a better choice,” Dr. Kerdel said. “Patients taking etanercept may need a biweekly dose.”
Treatment flexibility also comes into play. For example, stopping therapy because of an infection or surgery may be problematic in drugs with a long half-life. Then there’s the issue of patient preference. “Some people don’t want to be injected frequently,” he said. “Some people don’t want to be injected at all and may require a simpler dosing regimen.”
Optimizing anti-TNF-alpha treatment starts with recognizing that there is a loss of response over time, Dr. Kerdel said, “or there may not be a response at all.” Contributing factors may include immunogenicity, suboptimal dosing, and poor patient adherence. In order to optimize treatment, clinicians can try switching agents or combination therapy, and explore continuous versus intermittent dosing.
“We really don’t have good data on the best protocol for switching treatment after failure of an anti-TNF-alpha agent,” he added. In cases of primary and secondary treatment failure, there is no consensus or guidelines on which second-line agent to use, nor good data on which measures to use.
No evidence-based guidelines are available for screening and monitoring patients receiving biologic therapy for psoriasis, either. “Evidence is strongest [grade B] for tuberculosis screening in patients treated with biologic agents,” Dr. Kerdel said. “Among known hepatitis B virus carriers, consider monitoring liver function tests and viral load [grade C]. High-grade evidence is lacking to support other routine testing. Physicians should use clinical judgment when screening and monitoring patients.”
He concluded his presentation by noting that there are a number of biosimilar agents available or in the pipeline for infliximab, adalimumab, and etanercept. This raises a number of questions for current and future consideration. For one, “will biosimilars show the same long-term efficacy and safety as the innovator products?” he asked. “Real-world, postmarketing, and registry data are needed. Will biosimilar agents offer significant cost benefits? Will biosimilar labeling be adequately transparent? Will we find biomarkers to help us target biologic agents to specific patients and subtypes of psoriasis?”
Dr. Kerdel reported that he is a member of the speaker’s bureau for AbbVie, Amgen, Celgene, Janssen, Novartis, Lilly, Leo, Ortho, and Novartis. He has also received grant/research support from AbbVie, Amgen, AstraZeneca, Celgene, Janssen, Leo, Lilly, Menlo Therapeutics, Novartis, Pfizer, and XBiotech.
SDEF and this news organization are owned by the same parent company.
EXPERT ANALYSIS FROM THE SDEF LAS VEGAS DERMATOLOGY SEMINAR
Narrowband UVB phototherapy an effective treatment for psoriasis
LAS VEGAS – professor and chair of dermatology at the Medical College of Wisconsin, Milwaukee.
At the Skin Disease Education Foundation’s annual Las Vegas Dermatology Seminar, Dr. Gordon said that he uses phototherapy most in patients “who can’t get to all of the spots without it,” and in those whose disease is not having a huge impact on day-to-day life. “In my experience it’s best in people with thinner plaques, though I have some question over whether we can figure out if morphology really does correlate to respond to phototherapy,” he added. “We’re in the process of conducting a study to try and figure that out.”
From an immunologic standpoint, UVB decreases responsiveness of the interleukin-17 pathway and increases both cutaneous and circulating FoxP3+ cells, he said. Activation of p38 mitogen–activated protein kinase during phototherapy inhibits proinflammatory T-cell activation. In Dr. Gordon’s opinion, phototherapy is absolutely contraindicated in patients who have a photosensitivity reaction related to the UVB spectrum, while it is relatively contraindicated in those at high risk for skin cancer, including patients with multiple squamous cell carcinomas and those who have undergone organ transplantation. “I would argue that [the use of] photosensitizing drugs are not a contraindication,” he said. “Would I prefer that someone who’s had 54 [squamous cell carcinomas] not use phototherapy? Of course. But if it’s the only weapon I have, I’ll use it.”
Although clinicians have used phototherapy for about 100 years, early standards for clinical trials were different, compared with the rigor required of those conducted in the current era. Outcomes were not standardized, he said, and they were generally smaller trials that did not incorporate proper monitoring of adverse events. “Even with these weaknesses, we can get a general impression of how well UV works,” he said. In a 6-week, split-body trial of 11 patients from 20 years ago, researchers were able to induce clinical clearing in 82% of patients after narrowband UVB (the type most commonly used today), but in only 9% of patients after broadband UVB treatment (P less than .01) (J Am Acad Dermatol. 1999 Jun;40[6 Pt 1]:893-900).
Most clinicians commence narrowband UVB phototherapy treatment with three sessions per week and safely increase the dose to reach an effective level. Erythema can develop with overdosing. “If a patient can only come in twice weekly [for phototherapy treatment], that is okay,” Dr. Gordon said. “It takes a longer time getting to treatment goals. In my opinion, going down to once a week during the escalating phase of using phototherapy doesn’t work. Three times a week is better than twice a week during the escalating phase, but one time a week isn’t enough.”
Even for maintenance therapy, it remains a question whether limiting phototherapy to once every 2 or 4 weeks is sufficient for disease control. “I let the patient choose, but I like to go down to no less than once a week and hold people steady at that dose,” he said.
Purported risks of narrowband UVB phototherapy include photoaging, sunburn, herpes simplex virus reactivation, loss of the patient’s productive time, and development of skin cancer. “I don’t think we have good data about the effect of phototherapy on photoaging,” Dr. Gordon said. “Loss of productive time is my single biggest [complaint]. People are having trouble getting to work and having bosses who are not pleased with them [leaving work for treatment].”
As for the association between phototherapy and skin cancer, he noted that published studies that show statistical differences all incorporate psoralen-UVA photochemotherapy into their analyses. “There’s really no study that has demonstrated a significant impact on nonmelanoma skin cancers with the use of phototherapy [alone],” Dr. Gordon said. A British study of 3,867 psoriasis patients found no significant association between narrowband UVB treatment and basal cell cancer, squamous cell cancer, or melanoma (Br J Dermatol. 2008 Sep;159[4]:931-5). However, among those who also were treated with psoralen-UVA photochemotherapy, there was a small increase in basal cell cancer.
In a more recent Swedish study of 162 psoriasis patients who were treated with UVB phototherapy, researchers found that, after controlling for age, the risk of skin cancer was associated with the number of treatments, but not with the type of UVB lamp used (Acta Derm Venereol. 2014 Jul;94[4]:425-30). They reported that overall, the risk of malignancy in the UVB-treated patients did not exceed that in the general population.
Dr. Gordon concluded his presentation by noting that home-based UVB phototherapy is gaining in popularity and is comparable with in-office UVB in terms of accuracy and efficacy (BMJ. 2009;338:b1542). Because of convenience and decreased time away from work, he said, “it’s easier for patients ... and it’s probably cheaper in the long run.” The National Psoriasis Foundation web site includes a list of home UVB equipment.
Dr. Gordon disclosed that he is a consultant with AbbVie, Almirall, Amgen, Bristol-Meyers Squibb, Celgene, Dermavant, Eli Lilly, Janssen, Leo, Novartis, Ortho Dermatologics, Pfizer, Sun Pharma, and UCB. He has also received grant/research support from AbbVie, Bristol-Myers Squibb, Celgene, Eli Lilly, Janssen, and Novartis.
SDEF and this news organization are owned by the same parent company.
LAS VEGAS – professor and chair of dermatology at the Medical College of Wisconsin, Milwaukee.
At the Skin Disease Education Foundation’s annual Las Vegas Dermatology Seminar, Dr. Gordon said that he uses phototherapy most in patients “who can’t get to all of the spots without it,” and in those whose disease is not having a huge impact on day-to-day life. “In my experience it’s best in people with thinner plaques, though I have some question over whether we can figure out if morphology really does correlate to respond to phototherapy,” he added. “We’re in the process of conducting a study to try and figure that out.”
From an immunologic standpoint, UVB decreases responsiveness of the interleukin-17 pathway and increases both cutaneous and circulating FoxP3+ cells, he said. Activation of p38 mitogen–activated protein kinase during phototherapy inhibits proinflammatory T-cell activation. In Dr. Gordon’s opinion, phototherapy is absolutely contraindicated in patients who have a photosensitivity reaction related to the UVB spectrum, while it is relatively contraindicated in those at high risk for skin cancer, including patients with multiple squamous cell carcinomas and those who have undergone organ transplantation. “I would argue that [the use of] photosensitizing drugs are not a contraindication,” he said. “Would I prefer that someone who’s had 54 [squamous cell carcinomas] not use phototherapy? Of course. But if it’s the only weapon I have, I’ll use it.”
Although clinicians have used phototherapy for about 100 years, early standards for clinical trials were different, compared with the rigor required of those conducted in the current era. Outcomes were not standardized, he said, and they were generally smaller trials that did not incorporate proper monitoring of adverse events. “Even with these weaknesses, we can get a general impression of how well UV works,” he said. In a 6-week, split-body trial of 11 patients from 20 years ago, researchers were able to induce clinical clearing in 82% of patients after narrowband UVB (the type most commonly used today), but in only 9% of patients after broadband UVB treatment (P less than .01) (J Am Acad Dermatol. 1999 Jun;40[6 Pt 1]:893-900).
Most clinicians commence narrowband UVB phototherapy treatment with three sessions per week and safely increase the dose to reach an effective level. Erythema can develop with overdosing. “If a patient can only come in twice weekly [for phototherapy treatment], that is okay,” Dr. Gordon said. “It takes a longer time getting to treatment goals. In my opinion, going down to once a week during the escalating phase of using phototherapy doesn’t work. Three times a week is better than twice a week during the escalating phase, but one time a week isn’t enough.”
Even for maintenance therapy, it remains a question whether limiting phototherapy to once every 2 or 4 weeks is sufficient for disease control. “I let the patient choose, but I like to go down to no less than once a week and hold people steady at that dose,” he said.
Purported risks of narrowband UVB phototherapy include photoaging, sunburn, herpes simplex virus reactivation, loss of the patient’s productive time, and development of skin cancer. “I don’t think we have good data about the effect of phototherapy on photoaging,” Dr. Gordon said. “Loss of productive time is my single biggest [complaint]. People are having trouble getting to work and having bosses who are not pleased with them [leaving work for treatment].”
As for the association between phototherapy and skin cancer, he noted that published studies that show statistical differences all incorporate psoralen-UVA photochemotherapy into their analyses. “There’s really no study that has demonstrated a significant impact on nonmelanoma skin cancers with the use of phototherapy [alone],” Dr. Gordon said. A British study of 3,867 psoriasis patients found no significant association between narrowband UVB treatment and basal cell cancer, squamous cell cancer, or melanoma (Br J Dermatol. 2008 Sep;159[4]:931-5). However, among those who also were treated with psoralen-UVA photochemotherapy, there was a small increase in basal cell cancer.
In a more recent Swedish study of 162 psoriasis patients who were treated with UVB phototherapy, researchers found that, after controlling for age, the risk of skin cancer was associated with the number of treatments, but not with the type of UVB lamp used (Acta Derm Venereol. 2014 Jul;94[4]:425-30). They reported that overall, the risk of malignancy in the UVB-treated patients did not exceed that in the general population.
Dr. Gordon concluded his presentation by noting that home-based UVB phototherapy is gaining in popularity and is comparable with in-office UVB in terms of accuracy and efficacy (BMJ. 2009;338:b1542). Because of convenience and decreased time away from work, he said, “it’s easier for patients ... and it’s probably cheaper in the long run.” The National Psoriasis Foundation web site includes a list of home UVB equipment.
Dr. Gordon disclosed that he is a consultant with AbbVie, Almirall, Amgen, Bristol-Meyers Squibb, Celgene, Dermavant, Eli Lilly, Janssen, Leo, Novartis, Ortho Dermatologics, Pfizer, Sun Pharma, and UCB. He has also received grant/research support from AbbVie, Bristol-Myers Squibb, Celgene, Eli Lilly, Janssen, and Novartis.
SDEF and this news organization are owned by the same parent company.
LAS VEGAS – professor and chair of dermatology at the Medical College of Wisconsin, Milwaukee.
At the Skin Disease Education Foundation’s annual Las Vegas Dermatology Seminar, Dr. Gordon said that he uses phototherapy most in patients “who can’t get to all of the spots without it,” and in those whose disease is not having a huge impact on day-to-day life. “In my experience it’s best in people with thinner plaques, though I have some question over whether we can figure out if morphology really does correlate to respond to phototherapy,” he added. “We’re in the process of conducting a study to try and figure that out.”
From an immunologic standpoint, UVB decreases responsiveness of the interleukin-17 pathway and increases both cutaneous and circulating FoxP3+ cells, he said. Activation of p38 mitogen–activated protein kinase during phototherapy inhibits proinflammatory T-cell activation. In Dr. Gordon’s opinion, phototherapy is absolutely contraindicated in patients who have a photosensitivity reaction related to the UVB spectrum, while it is relatively contraindicated in those at high risk for skin cancer, including patients with multiple squamous cell carcinomas and those who have undergone organ transplantation. “I would argue that [the use of] photosensitizing drugs are not a contraindication,” he said. “Would I prefer that someone who’s had 54 [squamous cell carcinomas] not use phototherapy? Of course. But if it’s the only weapon I have, I’ll use it.”
Although clinicians have used phototherapy for about 100 years, early standards for clinical trials were different, compared with the rigor required of those conducted in the current era. Outcomes were not standardized, he said, and they were generally smaller trials that did not incorporate proper monitoring of adverse events. “Even with these weaknesses, we can get a general impression of how well UV works,” he said. In a 6-week, split-body trial of 11 patients from 20 years ago, researchers were able to induce clinical clearing in 82% of patients after narrowband UVB (the type most commonly used today), but in only 9% of patients after broadband UVB treatment (P less than .01) (J Am Acad Dermatol. 1999 Jun;40[6 Pt 1]:893-900).
Most clinicians commence narrowband UVB phototherapy treatment with three sessions per week and safely increase the dose to reach an effective level. Erythema can develop with overdosing. “If a patient can only come in twice weekly [for phototherapy treatment], that is okay,” Dr. Gordon said. “It takes a longer time getting to treatment goals. In my opinion, going down to once a week during the escalating phase of using phototherapy doesn’t work. Three times a week is better than twice a week during the escalating phase, but one time a week isn’t enough.”
Even for maintenance therapy, it remains a question whether limiting phototherapy to once every 2 or 4 weeks is sufficient for disease control. “I let the patient choose, but I like to go down to no less than once a week and hold people steady at that dose,” he said.
Purported risks of narrowband UVB phototherapy include photoaging, sunburn, herpes simplex virus reactivation, loss of the patient’s productive time, and development of skin cancer. “I don’t think we have good data about the effect of phototherapy on photoaging,” Dr. Gordon said. “Loss of productive time is my single biggest [complaint]. People are having trouble getting to work and having bosses who are not pleased with them [leaving work for treatment].”
As for the association between phototherapy and skin cancer, he noted that published studies that show statistical differences all incorporate psoralen-UVA photochemotherapy into their analyses. “There’s really no study that has demonstrated a significant impact on nonmelanoma skin cancers with the use of phototherapy [alone],” Dr. Gordon said. A British study of 3,867 psoriasis patients found no significant association between narrowband UVB treatment and basal cell cancer, squamous cell cancer, or melanoma (Br J Dermatol. 2008 Sep;159[4]:931-5). However, among those who also were treated with psoralen-UVA photochemotherapy, there was a small increase in basal cell cancer.
In a more recent Swedish study of 162 psoriasis patients who were treated with UVB phototherapy, researchers found that, after controlling for age, the risk of skin cancer was associated with the number of treatments, but not with the type of UVB lamp used (Acta Derm Venereol. 2014 Jul;94[4]:425-30). They reported that overall, the risk of malignancy in the UVB-treated patients did not exceed that in the general population.
Dr. Gordon concluded his presentation by noting that home-based UVB phototherapy is gaining in popularity and is comparable with in-office UVB in terms of accuracy and efficacy (BMJ. 2009;338:b1542). Because of convenience and decreased time away from work, he said, “it’s easier for patients ... and it’s probably cheaper in the long run.” The National Psoriasis Foundation web site includes a list of home UVB equipment.
Dr. Gordon disclosed that he is a consultant with AbbVie, Almirall, Amgen, Bristol-Meyers Squibb, Celgene, Dermavant, Eli Lilly, Janssen, Leo, Novartis, Ortho Dermatologics, Pfizer, Sun Pharma, and UCB. He has also received grant/research support from AbbVie, Bristol-Myers Squibb, Celgene, Eli Lilly, Janssen, and Novartis.
SDEF and this news organization are owned by the same parent company.
EXPERT ANALYSIS FROM THE SDEF LAS VEGAS DERMATOLOGY SEMINAR
Adding mental health clinicians to your practice is full of benefits
NEW ORLEANS – The way Jay Rabinowitz, MD, MPH, sees it, providing mental and behavioral health care services in your primary care pediatrics practice is a win-win for patients, parents, and clinicians.
For one thing, children with mental and behavioral issues – especially depression and anxiety – make up a good chunk of any pediatrician’s workday. Dr. Rabinowitz, clinical professor of pediatrics at the University of Colorado, Aurora, said at the annual meeting of the American Academy of Pediatrics. “It is the most costly issue in children’s health care today.”
According to “Behavioral Health Integration in Pediatric Primary Care,” a report supported by the Milbank Memorial Fund, one in five children aged 9-17 years have a diagnosable psychiatric disorder, and up to 70% of children in the juvenile justice system have a mental health disorder. The report also found that the treatment of mental health disorders accounts for the most costly childhood medical expenditure, and that between 15% and 20% of children with psychiatric disorders receive specialty care; the rest see their primary care provider. A long-term cost analysis showed significant cost savings: $1 spent on collaborative care saves $6.50 on health care costs.
More recently, the Guidelines for Adolescent Depression in Primary Care (GLAD-PC) found that only 50% of adolescents with depression are diagnosed before reaching adulthood (Pediatrics. March 2018;141[3]:e20174081). As many as two out of three youth with depression are not identified by their pediatrician and do not receive any kind of care.
“Even when diagnosed, only half of these patients are treated appropriately,” said Dr. Rabinowitz, who also practices at Parker (Colo.) Pediatrics and Adolescents.
The guidelines also found that reliance on self-report depression checklists alone lead to substantial numbers of false-positive and false-negative cases. “Primary care providers will benefit from having access to ongoing consultation with mental health providers,” according to the guidelines.
“Integrative care was associated with significant decreases in depression scores, and improved response and remission rates at 12 months, compared with treatment as usual,” Dr. Rabinowitz said.
Providing mental health services in a primary care pediatrics setting also makes sense because there’s a shortage of psychiatrists and psychologists to see them, and it enables patients to get evaluated quicker. “It’s convenient, and it reduces stigma,” he added. “It’s a familiar setting, a familiar provider, and they’re more likely to initiate counseling. Nationwide, 50% of patients who are referred for mental health do not make their initial appointment. Think about that. If you had diabetics in your practice and only 50% would go to the endocrinologist, what would you think?”
How Dr. Rabinowitz and his partners got started
Dr. Rabinowitz and his colleagues created an integrated care model in 2008 by adding a psychologist to their practice, but before doing that, they asked parents of children with mental and behavioral health issues what type of insurance they had. Then they obtained a referral list from the family’s insurer and hoped for the best. “Sometimes I referred to someone I may not have heard of,” Dr. Rabinowitz said. “Usually I did not get follow-up reports, or even know for sure if the patient ever went.”
Today, Parker Pediatrics and Adolescents employs three doctoral-level psychologists: one full-time, one three-quarter time, and one half-time, as well as one master’s-level therapist who works half-time.
“On any given day, we have at least two counselors in our office,” said Lindsey Einhorn, PhD, a licensed clinical psychologist who joined the practice in 2011. She and her colleagues care for children and teens with ADHD, depression, anxiety, behavioral and adjustment disorders, drug counseling, behavioral addictions, social struggles such as bullying, obsessive compulsive disorder (OCD), loss, hair or eyelash pulling, mood dysregulation, and sibling conflict. They refer for educational testing, comprehensive psychological evaluations, difficult divorce cases, play therapy, complex cases requiring more than 20 sessions, and children of staff employed by the practice.
The practice features a separate waiting room for psychology patients and front office staff dedicated to managing their schedules. “For anyone who’s trying to make a psychology appointment but can’t be seen in an efficient manner or wants a different day or time, we keep an ongoing move-up list,” Dr. Einhorn said. “If a family calls to cancel an appointment, the front desk person who makes that cancellation will fill out a slip and give it to one of our psychology schedulers. That person will create a move-up list and start filling that appointment. If there’s a cancellation, it’s rare that it goes unfilled.”
Key forms for parents to complete include informed consent, a notice of privacy practices, a late cancel/no show policy, an initial intake agreement, and a summary of parent concerns.
Patient and clinician reaction
According to results from a recent survey of parents whose children were seen by a psychologist at Parker Pediatrics and Adolescents, 89% said it was important for their children to receive mental health services in the same location as their medical care, and 96% were satisfied with the services provided. In addition, 93% said that the experience benefited their child, 72% were satisfied with appointment times, and 55% expressed interest in virtual visits via telemedicine. Meanwhile, a survey of parents whose children have not been seen by a psychologist at the practice found that 65% knew a psychologist was on staff, and only 9% said that there were barriers to their child seeing a psychologist there.
Clinicians themselves benefit from having mental health specialists on site for referrals. “It enables you to be more efficient, and it saves time,” Dr. Rabinowitz said. “There’s knowledge and confidence gained, and it improves satisfaction because physicians don’t have to stay at the office later filling out referral forms. It meets the needs of your patients and their families, it attracts new patients, and you may be able to make some income on this.”
How to get started
Dr. Rabinowitz recommended that, once clinicians at a pediatric practice commit to expanding their services to include mental and behavioral health care, they should hold a corporate/partner meeting, assign responsibilities, and establish a timeline for implementation. “This is all very important,” he said. “Then you have to talk about what kind of arrangement you want to have. You could employ someone to join your practice, hire an independent contractor, establish a space share agreement, or have an out-of-office arrangement.”
For many years, clinicians at Parker Pediatrics and Adolescents had a psychologist perform ADHD evaluations on a consultative basis. “Then, as we saw a need for mental health services about a decade ago, we hired a part-time psychologist who did testing as well as counseling,” Dr. Rabinowitz said. “But that psychologist got very busy, so we hired a full-time psychologist. We continued to hire additional psychologists as need increased.”
Reimbursement issues
Numerous reimbursement barriers to providing mental health services in pediatric primary care exist, he noted, including a lack of payment if mental health codes are used, a lack of “incident to” payments in some areas of the country, existing reimbursement levels, and the fact that same-day billing of physical and mental health often is not allowed. “However, we have found that if we give flu shots during their mental health visit, [insurers] will cover the flu shot,” he said. “Reimbursement for screening is sometimes not covered very well.”
One reimbursement option is the fee-for-service/concierge model, “but that’s not an economic option for many,” he said. “You can’t see Medicaid patients in that model.” Joining a mental health networks is feasible, “but there is poor reimbursement,” he said. “It also creates another layer of administration.”
He recommends financial integration, “but you need to research your options because a lot of it is state dependent.” Other options include grants, insurance contracts, and seeking permission from Medicaid.
Mental health CPT codes that mental health clinicians at the practice commonly use include bill by time (CPT code 99214/15); psychotherapy session that lasts 16-37 minutes (CPT code 90832); psychotherapy session that lasts 38-52 minutes (CPT code 90834); and psychotherapy session that lasts more than 53 minutes (CPT code 90837). Clinicians also can bill by interactive complexity (CPT code 90785) and psychotherapy for crisis (CPT code 90839).
Dr. Rabinowitz and Dr. Einhorn reported having no financial disclosures.
NEW ORLEANS – The way Jay Rabinowitz, MD, MPH, sees it, providing mental and behavioral health care services in your primary care pediatrics practice is a win-win for patients, parents, and clinicians.
For one thing, children with mental and behavioral issues – especially depression and anxiety – make up a good chunk of any pediatrician’s workday. Dr. Rabinowitz, clinical professor of pediatrics at the University of Colorado, Aurora, said at the annual meeting of the American Academy of Pediatrics. “It is the most costly issue in children’s health care today.”
According to “Behavioral Health Integration in Pediatric Primary Care,” a report supported by the Milbank Memorial Fund, one in five children aged 9-17 years have a diagnosable psychiatric disorder, and up to 70% of children in the juvenile justice system have a mental health disorder. The report also found that the treatment of mental health disorders accounts for the most costly childhood medical expenditure, and that between 15% and 20% of children with psychiatric disorders receive specialty care; the rest see their primary care provider. A long-term cost analysis showed significant cost savings: $1 spent on collaborative care saves $6.50 on health care costs.
More recently, the Guidelines for Adolescent Depression in Primary Care (GLAD-PC) found that only 50% of adolescents with depression are diagnosed before reaching adulthood (Pediatrics. March 2018;141[3]:e20174081). As many as two out of three youth with depression are not identified by their pediatrician and do not receive any kind of care.
“Even when diagnosed, only half of these patients are treated appropriately,” said Dr. Rabinowitz, who also practices at Parker (Colo.) Pediatrics and Adolescents.
The guidelines also found that reliance on self-report depression checklists alone lead to substantial numbers of false-positive and false-negative cases. “Primary care providers will benefit from having access to ongoing consultation with mental health providers,” according to the guidelines.
“Integrative care was associated with significant decreases in depression scores, and improved response and remission rates at 12 months, compared with treatment as usual,” Dr. Rabinowitz said.
Providing mental health services in a primary care pediatrics setting also makes sense because there’s a shortage of psychiatrists and psychologists to see them, and it enables patients to get evaluated quicker. “It’s convenient, and it reduces stigma,” he added. “It’s a familiar setting, a familiar provider, and they’re more likely to initiate counseling. Nationwide, 50% of patients who are referred for mental health do not make their initial appointment. Think about that. If you had diabetics in your practice and only 50% would go to the endocrinologist, what would you think?”
How Dr. Rabinowitz and his partners got started
Dr. Rabinowitz and his colleagues created an integrated care model in 2008 by adding a psychologist to their practice, but before doing that, they asked parents of children with mental and behavioral health issues what type of insurance they had. Then they obtained a referral list from the family’s insurer and hoped for the best. “Sometimes I referred to someone I may not have heard of,” Dr. Rabinowitz said. “Usually I did not get follow-up reports, or even know for sure if the patient ever went.”
Today, Parker Pediatrics and Adolescents employs three doctoral-level psychologists: one full-time, one three-quarter time, and one half-time, as well as one master’s-level therapist who works half-time.
“On any given day, we have at least two counselors in our office,” said Lindsey Einhorn, PhD, a licensed clinical psychologist who joined the practice in 2011. She and her colleagues care for children and teens with ADHD, depression, anxiety, behavioral and adjustment disorders, drug counseling, behavioral addictions, social struggles such as bullying, obsessive compulsive disorder (OCD), loss, hair or eyelash pulling, mood dysregulation, and sibling conflict. They refer for educational testing, comprehensive psychological evaluations, difficult divorce cases, play therapy, complex cases requiring more than 20 sessions, and children of staff employed by the practice.
The practice features a separate waiting room for psychology patients and front office staff dedicated to managing their schedules. “For anyone who’s trying to make a psychology appointment but can’t be seen in an efficient manner or wants a different day or time, we keep an ongoing move-up list,” Dr. Einhorn said. “If a family calls to cancel an appointment, the front desk person who makes that cancellation will fill out a slip and give it to one of our psychology schedulers. That person will create a move-up list and start filling that appointment. If there’s a cancellation, it’s rare that it goes unfilled.”
Key forms for parents to complete include informed consent, a notice of privacy practices, a late cancel/no show policy, an initial intake agreement, and a summary of parent concerns.
Patient and clinician reaction
According to results from a recent survey of parents whose children were seen by a psychologist at Parker Pediatrics and Adolescents, 89% said it was important for their children to receive mental health services in the same location as their medical care, and 96% were satisfied with the services provided. In addition, 93% said that the experience benefited their child, 72% were satisfied with appointment times, and 55% expressed interest in virtual visits via telemedicine. Meanwhile, a survey of parents whose children have not been seen by a psychologist at the practice found that 65% knew a psychologist was on staff, and only 9% said that there were barriers to their child seeing a psychologist there.
Clinicians themselves benefit from having mental health specialists on site for referrals. “It enables you to be more efficient, and it saves time,” Dr. Rabinowitz said. “There’s knowledge and confidence gained, and it improves satisfaction because physicians don’t have to stay at the office later filling out referral forms. It meets the needs of your patients and their families, it attracts new patients, and you may be able to make some income on this.”
How to get started
Dr. Rabinowitz recommended that, once clinicians at a pediatric practice commit to expanding their services to include mental and behavioral health care, they should hold a corporate/partner meeting, assign responsibilities, and establish a timeline for implementation. “This is all very important,” he said. “Then you have to talk about what kind of arrangement you want to have. You could employ someone to join your practice, hire an independent contractor, establish a space share agreement, or have an out-of-office arrangement.”
For many years, clinicians at Parker Pediatrics and Adolescents had a psychologist perform ADHD evaluations on a consultative basis. “Then, as we saw a need for mental health services about a decade ago, we hired a part-time psychologist who did testing as well as counseling,” Dr. Rabinowitz said. “But that psychologist got very busy, so we hired a full-time psychologist. We continued to hire additional psychologists as need increased.”
Reimbursement issues
Numerous reimbursement barriers to providing mental health services in pediatric primary care exist, he noted, including a lack of payment if mental health codes are used, a lack of “incident to” payments in some areas of the country, existing reimbursement levels, and the fact that same-day billing of physical and mental health often is not allowed. “However, we have found that if we give flu shots during their mental health visit, [insurers] will cover the flu shot,” he said. “Reimbursement for screening is sometimes not covered very well.”
One reimbursement option is the fee-for-service/concierge model, “but that’s not an economic option for many,” he said. “You can’t see Medicaid patients in that model.” Joining a mental health networks is feasible, “but there is poor reimbursement,” he said. “It also creates another layer of administration.”
He recommends financial integration, “but you need to research your options because a lot of it is state dependent.” Other options include grants, insurance contracts, and seeking permission from Medicaid.
Mental health CPT codes that mental health clinicians at the practice commonly use include bill by time (CPT code 99214/15); psychotherapy session that lasts 16-37 minutes (CPT code 90832); psychotherapy session that lasts 38-52 minutes (CPT code 90834); and psychotherapy session that lasts more than 53 minutes (CPT code 90837). Clinicians also can bill by interactive complexity (CPT code 90785) and psychotherapy for crisis (CPT code 90839).
Dr. Rabinowitz and Dr. Einhorn reported having no financial disclosures.
NEW ORLEANS – The way Jay Rabinowitz, MD, MPH, sees it, providing mental and behavioral health care services in your primary care pediatrics practice is a win-win for patients, parents, and clinicians.
For one thing, children with mental and behavioral issues – especially depression and anxiety – make up a good chunk of any pediatrician’s workday. Dr. Rabinowitz, clinical professor of pediatrics at the University of Colorado, Aurora, said at the annual meeting of the American Academy of Pediatrics. “It is the most costly issue in children’s health care today.”
According to “Behavioral Health Integration in Pediatric Primary Care,” a report supported by the Milbank Memorial Fund, one in five children aged 9-17 years have a diagnosable psychiatric disorder, and up to 70% of children in the juvenile justice system have a mental health disorder. The report also found that the treatment of mental health disorders accounts for the most costly childhood medical expenditure, and that between 15% and 20% of children with psychiatric disorders receive specialty care; the rest see their primary care provider. A long-term cost analysis showed significant cost savings: $1 spent on collaborative care saves $6.50 on health care costs.
More recently, the Guidelines for Adolescent Depression in Primary Care (GLAD-PC) found that only 50% of adolescents with depression are diagnosed before reaching adulthood (Pediatrics. March 2018;141[3]:e20174081). As many as two out of three youth with depression are not identified by their pediatrician and do not receive any kind of care.
“Even when diagnosed, only half of these patients are treated appropriately,” said Dr. Rabinowitz, who also practices at Parker (Colo.) Pediatrics and Adolescents.
The guidelines also found that reliance on self-report depression checklists alone lead to substantial numbers of false-positive and false-negative cases. “Primary care providers will benefit from having access to ongoing consultation with mental health providers,” according to the guidelines.
“Integrative care was associated with significant decreases in depression scores, and improved response and remission rates at 12 months, compared with treatment as usual,” Dr. Rabinowitz said.
Providing mental health services in a primary care pediatrics setting also makes sense because there’s a shortage of psychiatrists and psychologists to see them, and it enables patients to get evaluated quicker. “It’s convenient, and it reduces stigma,” he added. “It’s a familiar setting, a familiar provider, and they’re more likely to initiate counseling. Nationwide, 50% of patients who are referred for mental health do not make their initial appointment. Think about that. If you had diabetics in your practice and only 50% would go to the endocrinologist, what would you think?”
How Dr. Rabinowitz and his partners got started
Dr. Rabinowitz and his colleagues created an integrated care model in 2008 by adding a psychologist to their practice, but before doing that, they asked parents of children with mental and behavioral health issues what type of insurance they had. Then they obtained a referral list from the family’s insurer and hoped for the best. “Sometimes I referred to someone I may not have heard of,” Dr. Rabinowitz said. “Usually I did not get follow-up reports, or even know for sure if the patient ever went.”
Today, Parker Pediatrics and Adolescents employs three doctoral-level psychologists: one full-time, one three-quarter time, and one half-time, as well as one master’s-level therapist who works half-time.
“On any given day, we have at least two counselors in our office,” said Lindsey Einhorn, PhD, a licensed clinical psychologist who joined the practice in 2011. She and her colleagues care for children and teens with ADHD, depression, anxiety, behavioral and adjustment disorders, drug counseling, behavioral addictions, social struggles such as bullying, obsessive compulsive disorder (OCD), loss, hair or eyelash pulling, mood dysregulation, and sibling conflict. They refer for educational testing, comprehensive psychological evaluations, difficult divorce cases, play therapy, complex cases requiring more than 20 sessions, and children of staff employed by the practice.
The practice features a separate waiting room for psychology patients and front office staff dedicated to managing their schedules. “For anyone who’s trying to make a psychology appointment but can’t be seen in an efficient manner or wants a different day or time, we keep an ongoing move-up list,” Dr. Einhorn said. “If a family calls to cancel an appointment, the front desk person who makes that cancellation will fill out a slip and give it to one of our psychology schedulers. That person will create a move-up list and start filling that appointment. If there’s a cancellation, it’s rare that it goes unfilled.”
Key forms for parents to complete include informed consent, a notice of privacy practices, a late cancel/no show policy, an initial intake agreement, and a summary of parent concerns.
Patient and clinician reaction
According to results from a recent survey of parents whose children were seen by a psychologist at Parker Pediatrics and Adolescents, 89% said it was important for their children to receive mental health services in the same location as their medical care, and 96% were satisfied with the services provided. In addition, 93% said that the experience benefited their child, 72% were satisfied with appointment times, and 55% expressed interest in virtual visits via telemedicine. Meanwhile, a survey of parents whose children have not been seen by a psychologist at the practice found that 65% knew a psychologist was on staff, and only 9% said that there were barriers to their child seeing a psychologist there.
Clinicians themselves benefit from having mental health specialists on site for referrals. “It enables you to be more efficient, and it saves time,” Dr. Rabinowitz said. “There’s knowledge and confidence gained, and it improves satisfaction because physicians don’t have to stay at the office later filling out referral forms. It meets the needs of your patients and their families, it attracts new patients, and you may be able to make some income on this.”
How to get started
Dr. Rabinowitz recommended that, once clinicians at a pediatric practice commit to expanding their services to include mental and behavioral health care, they should hold a corporate/partner meeting, assign responsibilities, and establish a timeline for implementation. “This is all very important,” he said. “Then you have to talk about what kind of arrangement you want to have. You could employ someone to join your practice, hire an independent contractor, establish a space share agreement, or have an out-of-office arrangement.”
For many years, clinicians at Parker Pediatrics and Adolescents had a psychologist perform ADHD evaluations on a consultative basis. “Then, as we saw a need for mental health services about a decade ago, we hired a part-time psychologist who did testing as well as counseling,” Dr. Rabinowitz said. “But that psychologist got very busy, so we hired a full-time psychologist. We continued to hire additional psychologists as need increased.”
Reimbursement issues
Numerous reimbursement barriers to providing mental health services in pediatric primary care exist, he noted, including a lack of payment if mental health codes are used, a lack of “incident to” payments in some areas of the country, existing reimbursement levels, and the fact that same-day billing of physical and mental health often is not allowed. “However, we have found that if we give flu shots during their mental health visit, [insurers] will cover the flu shot,” he said. “Reimbursement for screening is sometimes not covered very well.”
One reimbursement option is the fee-for-service/concierge model, “but that’s not an economic option for many,” he said. “You can’t see Medicaid patients in that model.” Joining a mental health networks is feasible, “but there is poor reimbursement,” he said. “It also creates another layer of administration.”
He recommends financial integration, “but you need to research your options because a lot of it is state dependent.” Other options include grants, insurance contracts, and seeking permission from Medicaid.
Mental health CPT codes that mental health clinicians at the practice commonly use include bill by time (CPT code 99214/15); psychotherapy session that lasts 16-37 minutes (CPT code 90832); psychotherapy session that lasts 38-52 minutes (CPT code 90834); and psychotherapy session that lasts more than 53 minutes (CPT code 90837). Clinicians also can bill by interactive complexity (CPT code 90785) and psychotherapy for crisis (CPT code 90839).
Dr. Rabinowitz and Dr. Einhorn reported having no financial disclosures.
EXPERT ANALYSIS FROM AAP 2019
Tide beginning to turn on vaccine hesitancy
NEW ORLEANS –
The shift began with the measles outbreak in Southern California in late 2014, he said. According to the Centers for Disease Control and Prevention, 125 measles cases with rash that occurred between Dec. 28, 2014, and Feb. 8, 2015, were confirmed in U.S. residents. Of these, 100 were California residents (MMWR. 2015 Feb 20;64[06];153-4).
“This outbreak spread ultimately to 25 states and involved 189 people,” Dr. Offit said at the annual meeting of the American Academy of Pediatrics. “It was in the news almost every day. As a consequence, there were measles outbreaks in New York, New Jersey, Florida, Oregon, and Texas, and Washington, which began to turn the public sentiment against the antivaccine movement.”
Even longstanding skeptics are changing their tune. Dr. Offit, professor of pediatrics in the division of infectious diseases at the Children’s Hospital of Philadelphia, cited a recent study from the Autism Science Foundation which found that 85% of parents of children with autism spectrum disorder don’t believe that vaccines cause the condition. “Although there will be parents who continue to believe that vaccines cause autism, most parents of children with autism don’t believe that,” he said. “Also, it’s a little hard to make your case that vaccines are dangerous and that you shouldn’t get them in the midst of outbreaks.”
Perhaps the greatest pushback against antivaccination efforts has been made in the legal arena. In 2019 alone, legislators in California banned parents from not vaccinating their kids because of personal beliefs, while lawmakers in New York repealed the religious exemption to vaccinate, those in Maine repealed the religious and philosophical exemption, those in New Jersey required detailed written explanation for religious exemption, and those in Washington State repealed the philosophical exemption for the MMR vaccine.
Pushback also is apparent on various social media platforms. For example, Dr. Offit said, Pinterest restricts vaccine search results to curb the spread of misinformation, YouTube removes ads from antivaccine channels, Amazon Prime has pulled antivaccination documentaries from its video service, and Facebook has taken steps to curb misinformation about vaccines. “With outbreaks and with children suffering, the media and public sentiment has largely turned against those who are vehemently against vaccines,” he said. “I’m talking about an angry, politically connected, lawyer-backed group of people who are conspiracy theorists, [those] who no matter what you say, they’re going to believe there’s a conspiracy theory to hurt their children and not believe you. When that group becomes big enough and you start to see outbreaks like we’ve seen, then it becomes an issue. That’s where it comes down to legislation. Is it your inalienable right as a U.S. citizen to allow your child to catch and transmit a potentially fatal infection? That’s what we’re struggling with now.”
When meeting with parents who are skeptical about vaccines or refuse their children to have them, Dr. Offit advises clinicians to “go down swinging” in favor of vaccination. He shared how his wife, Bonnie, a pediatrician who practices in suburban Philadelphia, counsels parents who raise such concerns. “The way she handled it initially was to do the best she could to eventually get people vaccinated,” he said. “She was successful about one-quarter of the time. Then she drew a line. She started saying to parents, ‘Look; don’t put me in a position where you are asking me to practice substandard care. I can’t send them out of this room knowing that there’s more measles out there, knowing that there’s mumps out there, knowing that there’s whooping cough out there, knowing that there’s pneumococcus and varicella out there. If this child leaves this office and is hurt by any of those viruses or bacteria and I knew I could have done something to prevent it, I couldn’t live with myself. If you’re going to let this child out without being vaccinated I can’t see you anymore because I’m responsible for the health of this child.’ With that [approach], she has been far more successful. Because at some level, if you continue to see that patient, you’re tacitly agreeing that it’s okay to [not vaccinate].”
In 2000, Dr. Offit and colleagues created the Vaccine Education Center at Children’s Hospital of Philadelphia, which provides complete, up-to-date, and reliable information about vaccines to parents and clinicians. It summarizes the purpose of each vaccine, and the relative risks and benefits in easy-to-read language. The CDC also maintains updated information about vaccines and immunizations on its web site. For his part, Dr. Offit tells parents that passing on an opportunity to vaccinate their child is not a risk-free choice. “If you choose not to get a vaccine you probably will get away with it, but you might not,” he said. “You are playing a game of Russian roulette. It may not be five empty chambers and one bullet, but maybe it’s 100,000 empty chambers and one bullet. There’s a bullet there.”
Dr. Offit reported having no relevant financial disclosures.
NEW ORLEANS –
The shift began with the measles outbreak in Southern California in late 2014, he said. According to the Centers for Disease Control and Prevention, 125 measles cases with rash that occurred between Dec. 28, 2014, and Feb. 8, 2015, were confirmed in U.S. residents. Of these, 100 were California residents (MMWR. 2015 Feb 20;64[06];153-4).
“This outbreak spread ultimately to 25 states and involved 189 people,” Dr. Offit said at the annual meeting of the American Academy of Pediatrics. “It was in the news almost every day. As a consequence, there were measles outbreaks in New York, New Jersey, Florida, Oregon, and Texas, and Washington, which began to turn the public sentiment against the antivaccine movement.”
Even longstanding skeptics are changing their tune. Dr. Offit, professor of pediatrics in the division of infectious diseases at the Children’s Hospital of Philadelphia, cited a recent study from the Autism Science Foundation which found that 85% of parents of children with autism spectrum disorder don’t believe that vaccines cause the condition. “Although there will be parents who continue to believe that vaccines cause autism, most parents of children with autism don’t believe that,” he said. “Also, it’s a little hard to make your case that vaccines are dangerous and that you shouldn’t get them in the midst of outbreaks.”
Perhaps the greatest pushback against antivaccination efforts has been made in the legal arena. In 2019 alone, legislators in California banned parents from not vaccinating their kids because of personal beliefs, while lawmakers in New York repealed the religious exemption to vaccinate, those in Maine repealed the religious and philosophical exemption, those in New Jersey required detailed written explanation for religious exemption, and those in Washington State repealed the philosophical exemption for the MMR vaccine.
Pushback also is apparent on various social media platforms. For example, Dr. Offit said, Pinterest restricts vaccine search results to curb the spread of misinformation, YouTube removes ads from antivaccine channels, Amazon Prime has pulled antivaccination documentaries from its video service, and Facebook has taken steps to curb misinformation about vaccines. “With outbreaks and with children suffering, the media and public sentiment has largely turned against those who are vehemently against vaccines,” he said. “I’m talking about an angry, politically connected, lawyer-backed group of people who are conspiracy theorists, [those] who no matter what you say, they’re going to believe there’s a conspiracy theory to hurt their children and not believe you. When that group becomes big enough and you start to see outbreaks like we’ve seen, then it becomes an issue. That’s where it comes down to legislation. Is it your inalienable right as a U.S. citizen to allow your child to catch and transmit a potentially fatal infection? That’s what we’re struggling with now.”
When meeting with parents who are skeptical about vaccines or refuse their children to have them, Dr. Offit advises clinicians to “go down swinging” in favor of vaccination. He shared how his wife, Bonnie, a pediatrician who practices in suburban Philadelphia, counsels parents who raise such concerns. “The way she handled it initially was to do the best she could to eventually get people vaccinated,” he said. “She was successful about one-quarter of the time. Then she drew a line. She started saying to parents, ‘Look; don’t put me in a position where you are asking me to practice substandard care. I can’t send them out of this room knowing that there’s more measles out there, knowing that there’s mumps out there, knowing that there’s whooping cough out there, knowing that there’s pneumococcus and varicella out there. If this child leaves this office and is hurt by any of those viruses or bacteria and I knew I could have done something to prevent it, I couldn’t live with myself. If you’re going to let this child out without being vaccinated I can’t see you anymore because I’m responsible for the health of this child.’ With that [approach], she has been far more successful. Because at some level, if you continue to see that patient, you’re tacitly agreeing that it’s okay to [not vaccinate].”
In 2000, Dr. Offit and colleagues created the Vaccine Education Center at Children’s Hospital of Philadelphia, which provides complete, up-to-date, and reliable information about vaccines to parents and clinicians. It summarizes the purpose of each vaccine, and the relative risks and benefits in easy-to-read language. The CDC also maintains updated information about vaccines and immunizations on its web site. For his part, Dr. Offit tells parents that passing on an opportunity to vaccinate their child is not a risk-free choice. “If you choose not to get a vaccine you probably will get away with it, but you might not,” he said. “You are playing a game of Russian roulette. It may not be five empty chambers and one bullet, but maybe it’s 100,000 empty chambers and one bullet. There’s a bullet there.”
Dr. Offit reported having no relevant financial disclosures.
NEW ORLEANS –
The shift began with the measles outbreak in Southern California in late 2014, he said. According to the Centers for Disease Control and Prevention, 125 measles cases with rash that occurred between Dec. 28, 2014, and Feb. 8, 2015, were confirmed in U.S. residents. Of these, 100 were California residents (MMWR. 2015 Feb 20;64[06];153-4).
“This outbreak spread ultimately to 25 states and involved 189 people,” Dr. Offit said at the annual meeting of the American Academy of Pediatrics. “It was in the news almost every day. As a consequence, there were measles outbreaks in New York, New Jersey, Florida, Oregon, and Texas, and Washington, which began to turn the public sentiment against the antivaccine movement.”
Even longstanding skeptics are changing their tune. Dr. Offit, professor of pediatrics in the division of infectious diseases at the Children’s Hospital of Philadelphia, cited a recent study from the Autism Science Foundation which found that 85% of parents of children with autism spectrum disorder don’t believe that vaccines cause the condition. “Although there will be parents who continue to believe that vaccines cause autism, most parents of children with autism don’t believe that,” he said. “Also, it’s a little hard to make your case that vaccines are dangerous and that you shouldn’t get them in the midst of outbreaks.”
Perhaps the greatest pushback against antivaccination efforts has been made in the legal arena. In 2019 alone, legislators in California banned parents from not vaccinating their kids because of personal beliefs, while lawmakers in New York repealed the religious exemption to vaccinate, those in Maine repealed the religious and philosophical exemption, those in New Jersey required detailed written explanation for religious exemption, and those in Washington State repealed the philosophical exemption for the MMR vaccine.
Pushback also is apparent on various social media platforms. For example, Dr. Offit said, Pinterest restricts vaccine search results to curb the spread of misinformation, YouTube removes ads from antivaccine channels, Amazon Prime has pulled antivaccination documentaries from its video service, and Facebook has taken steps to curb misinformation about vaccines. “With outbreaks and with children suffering, the media and public sentiment has largely turned against those who are vehemently against vaccines,” he said. “I’m talking about an angry, politically connected, lawyer-backed group of people who are conspiracy theorists, [those] who no matter what you say, they’re going to believe there’s a conspiracy theory to hurt their children and not believe you. When that group becomes big enough and you start to see outbreaks like we’ve seen, then it becomes an issue. That’s where it comes down to legislation. Is it your inalienable right as a U.S. citizen to allow your child to catch and transmit a potentially fatal infection? That’s what we’re struggling with now.”
When meeting with parents who are skeptical about vaccines or refuse their children to have them, Dr. Offit advises clinicians to “go down swinging” in favor of vaccination. He shared how his wife, Bonnie, a pediatrician who practices in suburban Philadelphia, counsels parents who raise such concerns. “The way she handled it initially was to do the best she could to eventually get people vaccinated,” he said. “She was successful about one-quarter of the time. Then she drew a line. She started saying to parents, ‘Look; don’t put me in a position where you are asking me to practice substandard care. I can’t send them out of this room knowing that there’s more measles out there, knowing that there’s mumps out there, knowing that there’s whooping cough out there, knowing that there’s pneumococcus and varicella out there. If this child leaves this office and is hurt by any of those viruses or bacteria and I knew I could have done something to prevent it, I couldn’t live with myself. If you’re going to let this child out without being vaccinated I can’t see you anymore because I’m responsible for the health of this child.’ With that [approach], she has been far more successful. Because at some level, if you continue to see that patient, you’re tacitly agreeing that it’s okay to [not vaccinate].”
In 2000, Dr. Offit and colleagues created the Vaccine Education Center at Children’s Hospital of Philadelphia, which provides complete, up-to-date, and reliable information about vaccines to parents and clinicians. It summarizes the purpose of each vaccine, and the relative risks and benefits in easy-to-read language. The CDC also maintains updated information about vaccines and immunizations on its web site. For his part, Dr. Offit tells parents that passing on an opportunity to vaccinate their child is not a risk-free choice. “If you choose not to get a vaccine you probably will get away with it, but you might not,” he said. “You are playing a game of Russian roulette. It may not be five empty chambers and one bullet, but maybe it’s 100,000 empty chambers and one bullet. There’s a bullet there.”
Dr. Offit reported having no relevant financial disclosures.
EXPERT ANALYSIS FROM AAP 2019
Options for acne treatment continue to advance
LAS VEGAS – according to Linda Stein Gold, MD, who reviewed the data on these two therapies, as well as cannabidiol (CBD) and an androgen receptor antagonist, which are currently in clinical trials, at the Skin Disease Education Foundation’s annual Las Vegas Dermatology Seminar.
When considering antibiotic therapy for patients with moderate to severe acne, sarecycline, approved for that indication in October 2018, has improved anti-inflammatory properties and a narrower spectrum of activity, compared with other tetracycline-class antibiotics used for the condition, according to Dr. Stein Gold, director of dermatology research at Henry Ford Health System in Detroit. In two identically designed, 12-week randomized trials, SC 1401 and SC1402, researchers evaluated the efficacy and safety of an approximate 1.5–mg/kg per day dose of sarecycline in comparison with placebo in patients with moderate to severe facial acne aged 9-45 years (J Drugs Dermatol. 2018 Sept 1;17[9]:987-96). “We started to see separation in the inflammatory lesions as early as week 3, and a nice separation versus placebo over the course of 12 weeks,” said Dr. Stein Gold, one of the study investigators. “In all, 22% of patients got clear or almost clear with monotherapy. That’s fairly good.”
She noted that there was consistency in the reductions of lesion count achieved in both studies. Improvements were seen through to 12 weeks, with statistically significant reduction seen as early as 3 weeks in both studies. Sarecycline was also statistically superior to placebo at every time point studied in both trials.
In order to be judged a successful outcome, the subject had to have a 12-week Investigator’s Global Assessment (IGA) score with a 2-point or greater decrease (improvement) from baseline score on the IGA in each location, for patients who have a baseline IGA of 2 or greater, and to be clear (0) or almost clear (1). The same IGA scale was used for the chest and back assessments as was used for facial acne; the researchers observed statistically significant improvements in IGA score for both chest and back acne across both studies at week 12.
Sarecycline also had a favorable safety profile, with no treatment-emergent vertigo or tinnitus adverse events, she noted. Treatment-emergent vestibular and phototoxic adverse events both occurred in fewer than 1% of sarecycline patients. Among females, rates of yeast infections were low. When she recommends a course of this drug for her patients, “I never overpromise,” she said. “I tell my acne patients, ‘We measure your success in weeks and months, not days.’ I always tell them, ‘Take a selfie today and take a selfie every few weeks. When you come back in, we’ll review your progress and see how things went.’ ”
Researchers have also been studying topical minocycline as a treatment option. Minocycline is a large molecule that Dr. Stein Gold characterized as being “very challenging” to deliver topically. “It’s also challenging to keep it stable in a topical formulation.” However, results from two identical phase 3 trials found 4% topical minocycline foam significantly reduced both inflammatory and noninflammatory lesions and improved IGA scores in patients with moderate to severe acne when treated daily for 12 weeks (J Am Acad Dermatol. 2019 Jan;80[1]:168-77).
“This drug has an interesting vehicle,” said Dr. Stein Gold, who was one of the study investigators. “If you take the vehicle itself and you put it next to sebum, it causes sebum to melt at lower temperatures. Why does this matter? If you’re dissolving sebum, maybe you’re creating an easier pathway for the drug to get delivered into the skin and into the hair follicles. We don’t know all the details.” In the two trials, 15%-31% of patients achieved clearance or near clearance of all lesions. “How did it do in terms of decreasing papules and pustules? It did pretty well,” she said. “We want drugs to meet their match in everything that we do.” In terms of tolerability, skin-related adverse events were reported in fewer than 1% of subjects treated with 4% topical minocycline foam. She noted that by delivering minocycline topically, “we get huge concentrations in the skin, but almost negligible amounts in the systemic circulation, which is important. We want to keep [the drug] in the skin; we don’t want it in our system.”
(The Food and Drug Administration approved minocycline foam 4% in October 2019 for treating inflammatory lesions associated with non-nodular moderate to severe acne).
Another potential treatment on the horizon is cortexolone 17a-propionate, a novel androgen receptor antagonist that inhibits production of lipids and inflammatory cytokines from sebocytes in vitro. “When used around the sebaceous gland, we find that the amount of sebum produced goes down,” she said, noting that phase 3 trials of the agent have been completed.
“We also find that abnormal keratinization subsequently goes down. Just putting this on the skin significantly reduced acne as monotherapy in patients with moderate to severe acne. We were able to get them to clear or almost clear. It worked on comedones, papules, and pustules. Hopefully, it will get FDA approval. This fills the one unmet need we haven’t had topically in terms of decreasing sebum production.”
Clinical trials of CBD are also under way for acne and atopic dermatitis. “It could work for acne because there are some studies showing that might work on sebaceous glands to decrease sebum production,” she said. “CBD has been shown to have positive effects on abnormal keratinization, and it has been shown to have anti-inflammatory effects. Maybe we’ll have another mechanism of action for acne.”
Dr. Gold disclosed that she is on the speakers bureau for Almirall, Galderma, Leo Pharma, Ortho Dermatologics, Pfizer, and Sanofi/Regeneron. She is a consultant for Dermavant, Foamix, Galderma, Leo Pharma, Pfizer, Novartis, Ortho Dermatologics, and holds stock/stock options in AbbVie, Dermavant, Eli Lilly, Foamix, Galderma, Incyte, Leo Pharma, Novartis, Ortho Dermatologics, Pfizer, and Sol-Gel.
SDEF and this news organization are owned by the same parent company.
LAS VEGAS – according to Linda Stein Gold, MD, who reviewed the data on these two therapies, as well as cannabidiol (CBD) and an androgen receptor antagonist, which are currently in clinical trials, at the Skin Disease Education Foundation’s annual Las Vegas Dermatology Seminar.
When considering antibiotic therapy for patients with moderate to severe acne, sarecycline, approved for that indication in October 2018, has improved anti-inflammatory properties and a narrower spectrum of activity, compared with other tetracycline-class antibiotics used for the condition, according to Dr. Stein Gold, director of dermatology research at Henry Ford Health System in Detroit. In two identically designed, 12-week randomized trials, SC 1401 and SC1402, researchers evaluated the efficacy and safety of an approximate 1.5–mg/kg per day dose of sarecycline in comparison with placebo in patients with moderate to severe facial acne aged 9-45 years (J Drugs Dermatol. 2018 Sept 1;17[9]:987-96). “We started to see separation in the inflammatory lesions as early as week 3, and a nice separation versus placebo over the course of 12 weeks,” said Dr. Stein Gold, one of the study investigators. “In all, 22% of patients got clear or almost clear with monotherapy. That’s fairly good.”
She noted that there was consistency in the reductions of lesion count achieved in both studies. Improvements were seen through to 12 weeks, with statistically significant reduction seen as early as 3 weeks in both studies. Sarecycline was also statistically superior to placebo at every time point studied in both trials.
In order to be judged a successful outcome, the subject had to have a 12-week Investigator’s Global Assessment (IGA) score with a 2-point or greater decrease (improvement) from baseline score on the IGA in each location, for patients who have a baseline IGA of 2 or greater, and to be clear (0) or almost clear (1). The same IGA scale was used for the chest and back assessments as was used for facial acne; the researchers observed statistically significant improvements in IGA score for both chest and back acne across both studies at week 12.
Sarecycline also had a favorable safety profile, with no treatment-emergent vertigo or tinnitus adverse events, she noted. Treatment-emergent vestibular and phototoxic adverse events both occurred in fewer than 1% of sarecycline patients. Among females, rates of yeast infections were low. When she recommends a course of this drug for her patients, “I never overpromise,” she said. “I tell my acne patients, ‘We measure your success in weeks and months, not days.’ I always tell them, ‘Take a selfie today and take a selfie every few weeks. When you come back in, we’ll review your progress and see how things went.’ ”
Researchers have also been studying topical minocycline as a treatment option. Minocycline is a large molecule that Dr. Stein Gold characterized as being “very challenging” to deliver topically. “It’s also challenging to keep it stable in a topical formulation.” However, results from two identical phase 3 trials found 4% topical minocycline foam significantly reduced both inflammatory and noninflammatory lesions and improved IGA scores in patients with moderate to severe acne when treated daily for 12 weeks (J Am Acad Dermatol. 2019 Jan;80[1]:168-77).
“This drug has an interesting vehicle,” said Dr. Stein Gold, who was one of the study investigators. “If you take the vehicle itself and you put it next to sebum, it causes sebum to melt at lower temperatures. Why does this matter? If you’re dissolving sebum, maybe you’re creating an easier pathway for the drug to get delivered into the skin and into the hair follicles. We don’t know all the details.” In the two trials, 15%-31% of patients achieved clearance or near clearance of all lesions. “How did it do in terms of decreasing papules and pustules? It did pretty well,” she said. “We want drugs to meet their match in everything that we do.” In terms of tolerability, skin-related adverse events were reported in fewer than 1% of subjects treated with 4% topical minocycline foam. She noted that by delivering minocycline topically, “we get huge concentrations in the skin, but almost negligible amounts in the systemic circulation, which is important. We want to keep [the drug] in the skin; we don’t want it in our system.”
(The Food and Drug Administration approved minocycline foam 4% in October 2019 for treating inflammatory lesions associated with non-nodular moderate to severe acne).
Another potential treatment on the horizon is cortexolone 17a-propionate, a novel androgen receptor antagonist that inhibits production of lipids and inflammatory cytokines from sebocytes in vitro. “When used around the sebaceous gland, we find that the amount of sebum produced goes down,” she said, noting that phase 3 trials of the agent have been completed.
“We also find that abnormal keratinization subsequently goes down. Just putting this on the skin significantly reduced acne as monotherapy in patients with moderate to severe acne. We were able to get them to clear or almost clear. It worked on comedones, papules, and pustules. Hopefully, it will get FDA approval. This fills the one unmet need we haven’t had topically in terms of decreasing sebum production.”
Clinical trials of CBD are also under way for acne and atopic dermatitis. “It could work for acne because there are some studies showing that might work on sebaceous glands to decrease sebum production,” she said. “CBD has been shown to have positive effects on abnormal keratinization, and it has been shown to have anti-inflammatory effects. Maybe we’ll have another mechanism of action for acne.”
Dr. Gold disclosed that she is on the speakers bureau for Almirall, Galderma, Leo Pharma, Ortho Dermatologics, Pfizer, and Sanofi/Regeneron. She is a consultant for Dermavant, Foamix, Galderma, Leo Pharma, Pfizer, Novartis, Ortho Dermatologics, and holds stock/stock options in AbbVie, Dermavant, Eli Lilly, Foamix, Galderma, Incyte, Leo Pharma, Novartis, Ortho Dermatologics, Pfizer, and Sol-Gel.
SDEF and this news organization are owned by the same parent company.
LAS VEGAS – according to Linda Stein Gold, MD, who reviewed the data on these two therapies, as well as cannabidiol (CBD) and an androgen receptor antagonist, which are currently in clinical trials, at the Skin Disease Education Foundation’s annual Las Vegas Dermatology Seminar.
When considering antibiotic therapy for patients with moderate to severe acne, sarecycline, approved for that indication in October 2018, has improved anti-inflammatory properties and a narrower spectrum of activity, compared with other tetracycline-class antibiotics used for the condition, according to Dr. Stein Gold, director of dermatology research at Henry Ford Health System in Detroit. In two identically designed, 12-week randomized trials, SC 1401 and SC1402, researchers evaluated the efficacy and safety of an approximate 1.5–mg/kg per day dose of sarecycline in comparison with placebo in patients with moderate to severe facial acne aged 9-45 years (J Drugs Dermatol. 2018 Sept 1;17[9]:987-96). “We started to see separation in the inflammatory lesions as early as week 3, and a nice separation versus placebo over the course of 12 weeks,” said Dr. Stein Gold, one of the study investigators. “In all, 22% of patients got clear or almost clear with monotherapy. That’s fairly good.”
She noted that there was consistency in the reductions of lesion count achieved in both studies. Improvements were seen through to 12 weeks, with statistically significant reduction seen as early as 3 weeks in both studies. Sarecycline was also statistically superior to placebo at every time point studied in both trials.
In order to be judged a successful outcome, the subject had to have a 12-week Investigator’s Global Assessment (IGA) score with a 2-point or greater decrease (improvement) from baseline score on the IGA in each location, for patients who have a baseline IGA of 2 or greater, and to be clear (0) or almost clear (1). The same IGA scale was used for the chest and back assessments as was used for facial acne; the researchers observed statistically significant improvements in IGA score for both chest and back acne across both studies at week 12.
Sarecycline also had a favorable safety profile, with no treatment-emergent vertigo or tinnitus adverse events, she noted. Treatment-emergent vestibular and phototoxic adverse events both occurred in fewer than 1% of sarecycline patients. Among females, rates of yeast infections were low. When she recommends a course of this drug for her patients, “I never overpromise,” she said. “I tell my acne patients, ‘We measure your success in weeks and months, not days.’ I always tell them, ‘Take a selfie today and take a selfie every few weeks. When you come back in, we’ll review your progress and see how things went.’ ”
Researchers have also been studying topical minocycline as a treatment option. Minocycline is a large molecule that Dr. Stein Gold characterized as being “very challenging” to deliver topically. “It’s also challenging to keep it stable in a topical formulation.” However, results from two identical phase 3 trials found 4% topical minocycline foam significantly reduced both inflammatory and noninflammatory lesions and improved IGA scores in patients with moderate to severe acne when treated daily for 12 weeks (J Am Acad Dermatol. 2019 Jan;80[1]:168-77).
“This drug has an interesting vehicle,” said Dr. Stein Gold, who was one of the study investigators. “If you take the vehicle itself and you put it next to sebum, it causes sebum to melt at lower temperatures. Why does this matter? If you’re dissolving sebum, maybe you’re creating an easier pathway for the drug to get delivered into the skin and into the hair follicles. We don’t know all the details.” In the two trials, 15%-31% of patients achieved clearance or near clearance of all lesions. “How did it do in terms of decreasing papules and pustules? It did pretty well,” she said. “We want drugs to meet their match in everything that we do.” In terms of tolerability, skin-related adverse events were reported in fewer than 1% of subjects treated with 4% topical minocycline foam. She noted that by delivering minocycline topically, “we get huge concentrations in the skin, but almost negligible amounts in the systemic circulation, which is important. We want to keep [the drug] in the skin; we don’t want it in our system.”
(The Food and Drug Administration approved minocycline foam 4% in October 2019 for treating inflammatory lesions associated with non-nodular moderate to severe acne).
Another potential treatment on the horizon is cortexolone 17a-propionate, a novel androgen receptor antagonist that inhibits production of lipids and inflammatory cytokines from sebocytes in vitro. “When used around the sebaceous gland, we find that the amount of sebum produced goes down,” she said, noting that phase 3 trials of the agent have been completed.
“We also find that abnormal keratinization subsequently goes down. Just putting this on the skin significantly reduced acne as monotherapy in patients with moderate to severe acne. We were able to get them to clear or almost clear. It worked on comedones, papules, and pustules. Hopefully, it will get FDA approval. This fills the one unmet need we haven’t had topically in terms of decreasing sebum production.”
Clinical trials of CBD are also under way for acne and atopic dermatitis. “It could work for acne because there are some studies showing that might work on sebaceous glands to decrease sebum production,” she said. “CBD has been shown to have positive effects on abnormal keratinization, and it has been shown to have anti-inflammatory effects. Maybe we’ll have another mechanism of action for acne.”
Dr. Gold disclosed that she is on the speakers bureau for Almirall, Galderma, Leo Pharma, Ortho Dermatologics, Pfizer, and Sanofi/Regeneron. She is a consultant for Dermavant, Foamix, Galderma, Leo Pharma, Pfizer, Novartis, Ortho Dermatologics, and holds stock/stock options in AbbVie, Dermavant, Eli Lilly, Foamix, Galderma, Incyte, Leo Pharma, Novartis, Ortho Dermatologics, Pfizer, and Sol-Gel.
SDEF and this news organization are owned by the same parent company.
AT THE SDEF LAS VEGAS DERMATOLOGY SEMINAR
Expert reviews strategies for diagnosing, treating onychomycosis
LAS VEGAS – The way Neal Bhatia, MD, sees it, there is no such thing as a classical presentation of onychomycosis.
“This is where proving your diagnosis is half the battle, even though we are sometimes using empiric therapy in suspected cases,” he said at Skin Disease Education Foundation’s annual Las Vegas Dermatology Seminar. “Prove the diagnosis and get the extra tests necessary.”
According to Dr. Bhatia, director of clinical dermatology research at San Diego-based Therapeutics Clinical Research, . With onychomycosis, the ultimate treatment goal from the standpoint of clinicians is no more fungus, he noted, while the desired endpoint from the standpoint of some patients is normal-looking nails.
“Endpoint failures in a research trial are not the same as what we tell patients in the clinic,” Dr. Bhatia said. “If you have a patient using something topical for 52 weeks and they see two-thirds of their nail improve, you’re not going to say, ‘Stop; you’re a failure now.’ You tell them, ‘Keep going and we’ll keep watching.’ But in the research world, it’s very different when you look at all of the different endpoints that have to be met at the finish line. It’s very important to measure success based on what that patient’s experiencing.”
According to Dr. Bhatia, diagnosing onychomycosis by visual assessment has a sensitivity of 77% and a specificity of 47%, while KOH has a sensitivity between 67% and 93% and specificity between 38% and 78%. PCR, meanwhile, “is quick, but it’s expensive and it has a high false-positive rate. So, in those difficult patients who aren’t responding [to treatment], maybe we can’t just trust our eyes alone [to make a diagnosis].”
Tests such as a KOH stain have low sensitivity, with high costs of more sensitive tests such as the periodic acid–Schiff (PAS) stain. In a recent study, researchers conducted a retrospective cohort analysis of 600 patients with toenail clippings sent for PAS stain during January 2000–December 2013 (J Am Acad Dermatol. 2015 May; 72(5):AB116). They reviewed records to determine which PAS stains were performed to confirm probable clinical diagnosis of onychomycosis.
The researchers found that 30% of toenail clippings were sent for confirmatory PAS staining by dermatologists, compared with 37% by podiatrists and 34% by other clinicians. Of these tests, 75% ordered by dermatologists were positive for fungus, compared with 81% ordered by podiatrists, and 66% ordered by other physicians. “The positive predictive value of clinical suspicion for true onychomycosis was high, and the findings question whether or not a confirmatory test is really necessary,” Dr. Bhatia said.
Preventative strategies to control recurrence of onychomycosis include using maintenance regimens of the recommended antifungal agent, discarding old shoes, alternating wearing different pairs of shoes, periodically disinfecting shoes, washing feet regularly, and alerting the physician to the first sign of infection.
In an effort to investigate strategies to minimize recurrence of onychomycosis, Dr. Bhatia and colleagues evaluated 73 patients over the course of 7 years who were taking either terbinafine or itraconazole (J Drugs Dermatol. 2016;15[3]:279-82). Thirty-six months later, the overall mean recurrence rate among patients was 14%. Prognostic factors influencing recurrence included patient’s family history; lifestyle; underlying physiology (presence of a very thick nail, extensive involvement of the entire nail unit, lateral nail disease and yellow spikes); physical trauma, especially in the elderly; concomitant disease, such as peripheral artery disease and/or diabetes; immunocompromised or immunosuppressed patients, and the presence of tinea pedis.
Based on their analysis, they recommended the following strategies to prevent or limit recurrence: prophylactic use of a topical antifungal twice-weekly for 2-3 years; periodic application of a topical antifungal to plantar surface and/or interdigital spaces; treatment of any coexisting tinea pedis; treating immediate family members; footwear and sock decontamination with antifungal powder; ultraviolet light or ozone; avoidance of activities known to risk spread of disease, such as communal swimming pools.
Dr. Bhatia concluded his presentation by noting that the ideal treatment for onychomycosis would not pose a systemic risk to the liver, heart, or other organs; would not require monitoring of labs; would not require debridement; and would not interact with other drugs. It would also penetrate the nail plate – especially the diseased nail – and would be quick drying.
SDEF and this news organization are owned by the same parent company.
Dr. Bhatia disclosed having affiliations with Actavis, Allergan, Anacor, Aqua, Bayer, Biofrontera, BiopharmX, Cipher, Dermira, Dusa, Exeltis, Ferndale, Foamix, Galderma, Intraderm, ISDIN, LaRoche-Posay, Leo, Novan, Novartis, PharmaDerm, Promius, Regeneron, Sanofi, Sun Pharma, and Valeant.
LAS VEGAS – The way Neal Bhatia, MD, sees it, there is no such thing as a classical presentation of onychomycosis.
“This is where proving your diagnosis is half the battle, even though we are sometimes using empiric therapy in suspected cases,” he said at Skin Disease Education Foundation’s annual Las Vegas Dermatology Seminar. “Prove the diagnosis and get the extra tests necessary.”
According to Dr. Bhatia, director of clinical dermatology research at San Diego-based Therapeutics Clinical Research, . With onychomycosis, the ultimate treatment goal from the standpoint of clinicians is no more fungus, he noted, while the desired endpoint from the standpoint of some patients is normal-looking nails.
“Endpoint failures in a research trial are not the same as what we tell patients in the clinic,” Dr. Bhatia said. “If you have a patient using something topical for 52 weeks and they see two-thirds of their nail improve, you’re not going to say, ‘Stop; you’re a failure now.’ You tell them, ‘Keep going and we’ll keep watching.’ But in the research world, it’s very different when you look at all of the different endpoints that have to be met at the finish line. It’s very important to measure success based on what that patient’s experiencing.”
According to Dr. Bhatia, diagnosing onychomycosis by visual assessment has a sensitivity of 77% and a specificity of 47%, while KOH has a sensitivity between 67% and 93% and specificity between 38% and 78%. PCR, meanwhile, “is quick, but it’s expensive and it has a high false-positive rate. So, in those difficult patients who aren’t responding [to treatment], maybe we can’t just trust our eyes alone [to make a diagnosis].”
Tests such as a KOH stain have low sensitivity, with high costs of more sensitive tests such as the periodic acid–Schiff (PAS) stain. In a recent study, researchers conducted a retrospective cohort analysis of 600 patients with toenail clippings sent for PAS stain during January 2000–December 2013 (J Am Acad Dermatol. 2015 May; 72(5):AB116). They reviewed records to determine which PAS stains were performed to confirm probable clinical diagnosis of onychomycosis.
The researchers found that 30% of toenail clippings were sent for confirmatory PAS staining by dermatologists, compared with 37% by podiatrists and 34% by other clinicians. Of these tests, 75% ordered by dermatologists were positive for fungus, compared with 81% ordered by podiatrists, and 66% ordered by other physicians. “The positive predictive value of clinical suspicion for true onychomycosis was high, and the findings question whether or not a confirmatory test is really necessary,” Dr. Bhatia said.
Preventative strategies to control recurrence of onychomycosis include using maintenance regimens of the recommended antifungal agent, discarding old shoes, alternating wearing different pairs of shoes, periodically disinfecting shoes, washing feet regularly, and alerting the physician to the first sign of infection.
In an effort to investigate strategies to minimize recurrence of onychomycosis, Dr. Bhatia and colleagues evaluated 73 patients over the course of 7 years who were taking either terbinafine or itraconazole (J Drugs Dermatol. 2016;15[3]:279-82). Thirty-six months later, the overall mean recurrence rate among patients was 14%. Prognostic factors influencing recurrence included patient’s family history; lifestyle; underlying physiology (presence of a very thick nail, extensive involvement of the entire nail unit, lateral nail disease and yellow spikes); physical trauma, especially in the elderly; concomitant disease, such as peripheral artery disease and/or diabetes; immunocompromised or immunosuppressed patients, and the presence of tinea pedis.
Based on their analysis, they recommended the following strategies to prevent or limit recurrence: prophylactic use of a topical antifungal twice-weekly for 2-3 years; periodic application of a topical antifungal to plantar surface and/or interdigital spaces; treatment of any coexisting tinea pedis; treating immediate family members; footwear and sock decontamination with antifungal powder; ultraviolet light or ozone; avoidance of activities known to risk spread of disease, such as communal swimming pools.
Dr. Bhatia concluded his presentation by noting that the ideal treatment for onychomycosis would not pose a systemic risk to the liver, heart, or other organs; would not require monitoring of labs; would not require debridement; and would not interact with other drugs. It would also penetrate the nail plate – especially the diseased nail – and would be quick drying.
SDEF and this news organization are owned by the same parent company.
Dr. Bhatia disclosed having affiliations with Actavis, Allergan, Anacor, Aqua, Bayer, Biofrontera, BiopharmX, Cipher, Dermira, Dusa, Exeltis, Ferndale, Foamix, Galderma, Intraderm, ISDIN, LaRoche-Posay, Leo, Novan, Novartis, PharmaDerm, Promius, Regeneron, Sanofi, Sun Pharma, and Valeant.
LAS VEGAS – The way Neal Bhatia, MD, sees it, there is no such thing as a classical presentation of onychomycosis.
“This is where proving your diagnosis is half the battle, even though we are sometimes using empiric therapy in suspected cases,” he said at Skin Disease Education Foundation’s annual Las Vegas Dermatology Seminar. “Prove the diagnosis and get the extra tests necessary.”
According to Dr. Bhatia, director of clinical dermatology research at San Diego-based Therapeutics Clinical Research, . With onychomycosis, the ultimate treatment goal from the standpoint of clinicians is no more fungus, he noted, while the desired endpoint from the standpoint of some patients is normal-looking nails.
“Endpoint failures in a research trial are not the same as what we tell patients in the clinic,” Dr. Bhatia said. “If you have a patient using something topical for 52 weeks and they see two-thirds of their nail improve, you’re not going to say, ‘Stop; you’re a failure now.’ You tell them, ‘Keep going and we’ll keep watching.’ But in the research world, it’s very different when you look at all of the different endpoints that have to be met at the finish line. It’s very important to measure success based on what that patient’s experiencing.”
According to Dr. Bhatia, diagnosing onychomycosis by visual assessment has a sensitivity of 77% and a specificity of 47%, while KOH has a sensitivity between 67% and 93% and specificity between 38% and 78%. PCR, meanwhile, “is quick, but it’s expensive and it has a high false-positive rate. So, in those difficult patients who aren’t responding [to treatment], maybe we can’t just trust our eyes alone [to make a diagnosis].”
Tests such as a KOH stain have low sensitivity, with high costs of more sensitive tests such as the periodic acid–Schiff (PAS) stain. In a recent study, researchers conducted a retrospective cohort analysis of 600 patients with toenail clippings sent for PAS stain during January 2000–December 2013 (J Am Acad Dermatol. 2015 May; 72(5):AB116). They reviewed records to determine which PAS stains were performed to confirm probable clinical diagnosis of onychomycosis.
The researchers found that 30% of toenail clippings were sent for confirmatory PAS staining by dermatologists, compared with 37% by podiatrists and 34% by other clinicians. Of these tests, 75% ordered by dermatologists were positive for fungus, compared with 81% ordered by podiatrists, and 66% ordered by other physicians. “The positive predictive value of clinical suspicion for true onychomycosis was high, and the findings question whether or not a confirmatory test is really necessary,” Dr. Bhatia said.
Preventative strategies to control recurrence of onychomycosis include using maintenance regimens of the recommended antifungal agent, discarding old shoes, alternating wearing different pairs of shoes, periodically disinfecting shoes, washing feet regularly, and alerting the physician to the first sign of infection.
In an effort to investigate strategies to minimize recurrence of onychomycosis, Dr. Bhatia and colleagues evaluated 73 patients over the course of 7 years who were taking either terbinafine or itraconazole (J Drugs Dermatol. 2016;15[3]:279-82). Thirty-six months later, the overall mean recurrence rate among patients was 14%. Prognostic factors influencing recurrence included patient’s family history; lifestyle; underlying physiology (presence of a very thick nail, extensive involvement of the entire nail unit, lateral nail disease and yellow spikes); physical trauma, especially in the elderly; concomitant disease, such as peripheral artery disease and/or diabetes; immunocompromised or immunosuppressed patients, and the presence of tinea pedis.
Based on their analysis, they recommended the following strategies to prevent or limit recurrence: prophylactic use of a topical antifungal twice-weekly for 2-3 years; periodic application of a topical antifungal to plantar surface and/or interdigital spaces; treatment of any coexisting tinea pedis; treating immediate family members; footwear and sock decontamination with antifungal powder; ultraviolet light or ozone; avoidance of activities known to risk spread of disease, such as communal swimming pools.
Dr. Bhatia concluded his presentation by noting that the ideal treatment for onychomycosis would not pose a systemic risk to the liver, heart, or other organs; would not require monitoring of labs; would not require debridement; and would not interact with other drugs. It would also penetrate the nail plate – especially the diseased nail – and would be quick drying.
SDEF and this news organization are owned by the same parent company.
Dr. Bhatia disclosed having affiliations with Actavis, Allergan, Anacor, Aqua, Bayer, Biofrontera, BiopharmX, Cipher, Dermira, Dusa, Exeltis, Ferndale, Foamix, Galderma, Intraderm, ISDIN, LaRoche-Posay, Leo, Novan, Novartis, PharmaDerm, Promius, Regeneron, Sanofi, Sun Pharma, and Valeant.
AT THE SDEF LAS VEGAS DERMATOLOGY SEMINAR
Researchers working to squash recurrence of superficial BCCs
LAS VEGAS – For according to Ervin H. Epstein, MD.
In a noninferiority trial, researchers in the Netherlands randomized 601 patients with superficial BCCs to one of three medical treatments: two treatments of photodynamic therapy (PDT) 1 week apart (group 1), imiquimod 5 days per week for 6 weeks with no occlusion (group 2), and 5-fluorouracil (5-FU) twice per day for 4 weeks with no occlusion (group 3). They followed the patients for 5 years to see which tumors came back (J Invest Dermatol. 2018 Mar;138[3]:527-33). At 5 years, tumor-free survival was 63% in group 1, 81% in group 2, and 70% in group 3. Based on this analysis the authors concluded that imiquimod is the first choice for noninvasive treatment of most primary BCCs.
“Yes, imiquimod is helpful, but it’s not as good as surgery,” Dr. Epstein said at the Skin Disease Education Foundation’s annual Las Vegas Dermatology Seminar.
Researchers like Dr. Epstein, a dermatologist at Brown & Toland Physicians in Oakland, Calif., have been exploring ways to reduce the recurrence of BCCs in those at high risk. One approach is to stay out of the sun, but that is not practical for most people, “and the data are not very supportive,” he said. “Very few people can actually avoid sunlight. What about topical 5-FU? Suppose you put on 5-FU and then study people for the next year, to see what the likelihood is of them getting a BCC? Why it has taken us so long to do this kind of study is in some ways shameful.” He mentioned one study in which patients at risk of superficial BCC recurrence applied topical 5-FU twice a day for 2-4 weeks. The regimen led to an 11% decrease in the development of BCCs, a trend that did not reach statistical significance.
Another approach to warding off BCC recurrence is to take oral hedgehog pathway inhibitors, which are highly effective. “The problem is, hedgehog pathway inhibitors have side effects that are not catastrophic, but they’re annoying,” Dr. Epstein said. “Patients can lose their hair, they get muscle cramps, and can lose their taste.”
To date, there have been at least three trials evaluating the feasibility of a topical hedgehog pathway inhibitor in adult subjects. In one of the trials, researchers evaluated the efficacy of LDE225, a selective antagonist of Smoothened, in eight patients with nevoid basal cell carcinoma syndrome. They were instructed to apply LDE225 twice per day for 4 weeks (J Invest Dermatol 2011 Aug;131[8]:1735-44). Of 13 BCCs treated in the patients, 12 had a partial to complete response. In fact, eight BCCs had an average of 56% volume reduction but none had complete histologic clearing.
At PellePharm, a biotechnology that Dr. Epstein cofounded, researchers are developing patidegib topical gel, 2%, for the reduction of disease burden of persistently developing BCCs in subjects with Gorlin syndrome. In a phase 3 trial, which just completed recruitment, adults are instructed to apply the gel twice daily to the face for 12 months. The primary endpoint is a comparison between the two treatment arms of the number of new surgically eligible BCCs that develop over the 12-month period. “We want to see if we can reduce the number of surgically eligible BCCs,” Dr. Epstein said. “We’re very hopeful.”
SDEF and this news organization are owned by the same parent company. Dr. Epstein spoke during a forum on cutaneous malignancies at the meeting.
Dr. Epstein disclosed that he has been a consultant for Genentech, Novartis, Amgen, and Infinity. He is also cofounder/director and stockholder in PellePharm.
LAS VEGAS – For according to Ervin H. Epstein, MD.
In a noninferiority trial, researchers in the Netherlands randomized 601 patients with superficial BCCs to one of three medical treatments: two treatments of photodynamic therapy (PDT) 1 week apart (group 1), imiquimod 5 days per week for 6 weeks with no occlusion (group 2), and 5-fluorouracil (5-FU) twice per day for 4 weeks with no occlusion (group 3). They followed the patients for 5 years to see which tumors came back (J Invest Dermatol. 2018 Mar;138[3]:527-33). At 5 years, tumor-free survival was 63% in group 1, 81% in group 2, and 70% in group 3. Based on this analysis the authors concluded that imiquimod is the first choice for noninvasive treatment of most primary BCCs.
“Yes, imiquimod is helpful, but it’s not as good as surgery,” Dr. Epstein said at the Skin Disease Education Foundation’s annual Las Vegas Dermatology Seminar.
Researchers like Dr. Epstein, a dermatologist at Brown & Toland Physicians in Oakland, Calif., have been exploring ways to reduce the recurrence of BCCs in those at high risk. One approach is to stay out of the sun, but that is not practical for most people, “and the data are not very supportive,” he said. “Very few people can actually avoid sunlight. What about topical 5-FU? Suppose you put on 5-FU and then study people for the next year, to see what the likelihood is of them getting a BCC? Why it has taken us so long to do this kind of study is in some ways shameful.” He mentioned one study in which patients at risk of superficial BCC recurrence applied topical 5-FU twice a day for 2-4 weeks. The regimen led to an 11% decrease in the development of BCCs, a trend that did not reach statistical significance.
Another approach to warding off BCC recurrence is to take oral hedgehog pathway inhibitors, which are highly effective. “The problem is, hedgehog pathway inhibitors have side effects that are not catastrophic, but they’re annoying,” Dr. Epstein said. “Patients can lose their hair, they get muscle cramps, and can lose their taste.”
To date, there have been at least three trials evaluating the feasibility of a topical hedgehog pathway inhibitor in adult subjects. In one of the trials, researchers evaluated the efficacy of LDE225, a selective antagonist of Smoothened, in eight patients with nevoid basal cell carcinoma syndrome. They were instructed to apply LDE225 twice per day for 4 weeks (J Invest Dermatol 2011 Aug;131[8]:1735-44). Of 13 BCCs treated in the patients, 12 had a partial to complete response. In fact, eight BCCs had an average of 56% volume reduction but none had complete histologic clearing.
At PellePharm, a biotechnology that Dr. Epstein cofounded, researchers are developing patidegib topical gel, 2%, for the reduction of disease burden of persistently developing BCCs in subjects with Gorlin syndrome. In a phase 3 trial, which just completed recruitment, adults are instructed to apply the gel twice daily to the face for 12 months. The primary endpoint is a comparison between the two treatment arms of the number of new surgically eligible BCCs that develop over the 12-month period. “We want to see if we can reduce the number of surgically eligible BCCs,” Dr. Epstein said. “We’re very hopeful.”
SDEF and this news organization are owned by the same parent company. Dr. Epstein spoke during a forum on cutaneous malignancies at the meeting.
Dr. Epstein disclosed that he has been a consultant for Genentech, Novartis, Amgen, and Infinity. He is also cofounder/director and stockholder in PellePharm.
LAS VEGAS – For according to Ervin H. Epstein, MD.
In a noninferiority trial, researchers in the Netherlands randomized 601 patients with superficial BCCs to one of three medical treatments: two treatments of photodynamic therapy (PDT) 1 week apart (group 1), imiquimod 5 days per week for 6 weeks with no occlusion (group 2), and 5-fluorouracil (5-FU) twice per day for 4 weeks with no occlusion (group 3). They followed the patients for 5 years to see which tumors came back (J Invest Dermatol. 2018 Mar;138[3]:527-33). At 5 years, tumor-free survival was 63% in group 1, 81% in group 2, and 70% in group 3. Based on this analysis the authors concluded that imiquimod is the first choice for noninvasive treatment of most primary BCCs.
“Yes, imiquimod is helpful, but it’s not as good as surgery,” Dr. Epstein said at the Skin Disease Education Foundation’s annual Las Vegas Dermatology Seminar.
Researchers like Dr. Epstein, a dermatologist at Brown & Toland Physicians in Oakland, Calif., have been exploring ways to reduce the recurrence of BCCs in those at high risk. One approach is to stay out of the sun, but that is not practical for most people, “and the data are not very supportive,” he said. “Very few people can actually avoid sunlight. What about topical 5-FU? Suppose you put on 5-FU and then study people for the next year, to see what the likelihood is of them getting a BCC? Why it has taken us so long to do this kind of study is in some ways shameful.” He mentioned one study in which patients at risk of superficial BCC recurrence applied topical 5-FU twice a day for 2-4 weeks. The regimen led to an 11% decrease in the development of BCCs, a trend that did not reach statistical significance.
Another approach to warding off BCC recurrence is to take oral hedgehog pathway inhibitors, which are highly effective. “The problem is, hedgehog pathway inhibitors have side effects that are not catastrophic, but they’re annoying,” Dr. Epstein said. “Patients can lose their hair, they get muscle cramps, and can lose their taste.”
To date, there have been at least three trials evaluating the feasibility of a topical hedgehog pathway inhibitor in adult subjects. In one of the trials, researchers evaluated the efficacy of LDE225, a selective antagonist of Smoothened, in eight patients with nevoid basal cell carcinoma syndrome. They were instructed to apply LDE225 twice per day for 4 weeks (J Invest Dermatol 2011 Aug;131[8]:1735-44). Of 13 BCCs treated in the patients, 12 had a partial to complete response. In fact, eight BCCs had an average of 56% volume reduction but none had complete histologic clearing.
At PellePharm, a biotechnology that Dr. Epstein cofounded, researchers are developing patidegib topical gel, 2%, for the reduction of disease burden of persistently developing BCCs in subjects with Gorlin syndrome. In a phase 3 trial, which just completed recruitment, adults are instructed to apply the gel twice daily to the face for 12 months. The primary endpoint is a comparison between the two treatment arms of the number of new surgically eligible BCCs that develop over the 12-month period. “We want to see if we can reduce the number of surgically eligible BCCs,” Dr. Epstein said. “We’re very hopeful.”
SDEF and this news organization are owned by the same parent company. Dr. Epstein spoke during a forum on cutaneous malignancies at the meeting.
Dr. Epstein disclosed that he has been a consultant for Genentech, Novartis, Amgen, and Infinity. He is also cofounder/director and stockholder in PellePharm.
EXPERT ANALYSIS FROM THE SDEF LAS VEGAS DERMATOLOGY SEMINAR
Melanoma incidence continues to increase, yet mortality stabilizing
LAS VEGAS – The according to data from the National Cancer Institute’s Surveillance, Epidemiology, and End Results (SEER) program.
At the Skin Disease Education Foundation’s annual Las Vegas Dermatology Seminar, Laura Korb Ferris, MD, PhD, said that SEER data project 96,480 new cases of melanoma in 2019, as well as 7,230 deaths from the disease. In 2016, SEER projected 10,130 deaths from melanoma, “so we’re actually projecting a reduction in melanoma deaths,” said Dr. Ferris, director of clinical trials at the University of Pittsburgh Medical Center’s department of dermatology. She added that the death rate from melanoma in 2016 was 2.17 per 100,000 population, a reduction from 2.69 per 100,000 population in 2011, “so it looks like melanoma mortality may be stable,” or even reduced, despite an increase in melanoma incidence.
A study of SEER data between 1989 and 2009 found that melanoma incidence is increasing across all lesion thicknesses (J Natl Cancer Inst. 2015 Nov 12. doi: 10.1093/jnci/djv294). Specifically, the incidence increased most among thin lesions, but there was a smaller increased incidence of thick melanoma. “This suggests that the overall burden of disease is truly increasing, but it is primarily stemming from an increase in T1/T2 disease,” Dr. Ferris said. “This could be due in part to increased early detection.”
Improvements in melanoma-specific survival, she continued, are likely a combination of improved management of T4 disease, a shift toward detection of thinner T1/T2 melanoma, and increased detection of T1/T2 disease.
The SEER data also showed that the incidence of fatal cases of melanoma has decreased since 1989, but only in thick melanomas. This trend may indicate a modest improvement in the management of T4 tumors. “Optimistically, I think increased detection efforts are improving survival by early detection of thin but ultimately fatal melanomas,” Dr. Ferris said. “Hopefully we are finding disease earlier and we are preventing patients from progressing to these fatal T4 melanomas.”
Disparities in melanoma-specific survival also come into play. Men have poorer survival compared with women, whites have the highest survival, and non-Hispanic whites have a better survival than Hispanic whites, Dr. Ferris said, while lower rates of survival are seen in blacks and nonblack minorities, as well as among those in high poverty and those who are separated/nonmarried. Lesion type also matters. The highest survival is seen in those with superficial spreading melanoma, while lower survival is observed in those with nodular melanoma, and acral lentiginous melanoma.
Early detection of thin nodular melanomas has the potential to significantly impact melanoma mortality, “but we want to keep in mind that the majority of ultimately fatal melanomas are superficial spreading melanomas,” Dr. Ferris said. “That is because they are so much more prevalent. As a dermatologist, I think a lot about screening and early detection. Periodic screening is a good strategy for a slower-growing superficial spreading melanoma, but it’s not necessarily a good strategy for a rapidly growing nodular melanoma. That’s going to require better education and better access to health care.”
Self-detection of melanoma is another strategy to consider. According to Dr. Ferris, results from multiple studies suggest that about 50% of all melanomas are detected by patients, but the ones they find tend to be thicker than the ones that clinicians detect during office visits. “It would be great if we can get that number higher than 50%,” Dr. Ferris said. “If patients really understood what melanoma is, what it looks like, and when they needed to seek medical attention, perhaps we could get that over 50% and see self-detection of thinner melanomas. That’s a very low-cost intervention.”
Targeted screening efforts that stratify by risk factors and by age “makes screening more efficient and more cost-effective,” she added. She cited one analysis, which found that clinicians need to screen 606 people and conduct 25 biopsies in order to find one melanoma. “That’s very resource intensive,” she said. “However, if you only screened people 50 or older or 65 or older, the number needed to screen goes down, and because your pretest probability is higher, your number need to biopsy goes down as well. If you factor in things like a history of atypical nevi or a personal history of melanoma, those patients are at a higher risk of developing melanoma.”
Dr. Ferris closed her presentation by noting that Australia leads other countries in melanoma prevention efforts. There, the combined incidence of skin cancer is higher than the incidence of any other type of cancer. Four decades ago, Australian health officials launched SunSmart, a series of initiatives intended to reduce skin cancer. These include implementation of policies for hat wearing and shade provision in schools and at work, availability of more effective sunscreens, inclusion of sun protection items as a tax-deductible expense for outdoor workers, increased availability since the 1980s of long-sleeved sun protective swimwear, a ban on the use of indoor tanning since 2014, provision of UV forecasts in weather, and a comprehensive program of grants for community shade structures (PLoSMed. 2019 Oct 8;16[10]:e1002932).
“One approach to melanoma prevention won’t fit all,” she concluded. “We need to focus on prevention, public education to improve knowledge and self-detection.”
Dr. Ferris disclosed that she is a consultant to and an investigator for DermTech and Scibase. She is also an investigator for Castle Biosciences.
SDEF and this news organization are owned by the same parent company. Dr. Ferris spoke during a forum on cutaneous malignancies at the meeting.
LAS VEGAS – The according to data from the National Cancer Institute’s Surveillance, Epidemiology, and End Results (SEER) program.
At the Skin Disease Education Foundation’s annual Las Vegas Dermatology Seminar, Laura Korb Ferris, MD, PhD, said that SEER data project 96,480 new cases of melanoma in 2019, as well as 7,230 deaths from the disease. In 2016, SEER projected 10,130 deaths from melanoma, “so we’re actually projecting a reduction in melanoma deaths,” said Dr. Ferris, director of clinical trials at the University of Pittsburgh Medical Center’s department of dermatology. She added that the death rate from melanoma in 2016 was 2.17 per 100,000 population, a reduction from 2.69 per 100,000 population in 2011, “so it looks like melanoma mortality may be stable,” or even reduced, despite an increase in melanoma incidence.
A study of SEER data between 1989 and 2009 found that melanoma incidence is increasing across all lesion thicknesses (J Natl Cancer Inst. 2015 Nov 12. doi: 10.1093/jnci/djv294). Specifically, the incidence increased most among thin lesions, but there was a smaller increased incidence of thick melanoma. “This suggests that the overall burden of disease is truly increasing, but it is primarily stemming from an increase in T1/T2 disease,” Dr. Ferris said. “This could be due in part to increased early detection.”
Improvements in melanoma-specific survival, she continued, are likely a combination of improved management of T4 disease, a shift toward detection of thinner T1/T2 melanoma, and increased detection of T1/T2 disease.
The SEER data also showed that the incidence of fatal cases of melanoma has decreased since 1989, but only in thick melanomas. This trend may indicate a modest improvement in the management of T4 tumors. “Optimistically, I think increased detection efforts are improving survival by early detection of thin but ultimately fatal melanomas,” Dr. Ferris said. “Hopefully we are finding disease earlier and we are preventing patients from progressing to these fatal T4 melanomas.”
Disparities in melanoma-specific survival also come into play. Men have poorer survival compared with women, whites have the highest survival, and non-Hispanic whites have a better survival than Hispanic whites, Dr. Ferris said, while lower rates of survival are seen in blacks and nonblack minorities, as well as among those in high poverty and those who are separated/nonmarried. Lesion type also matters. The highest survival is seen in those with superficial spreading melanoma, while lower survival is observed in those with nodular melanoma, and acral lentiginous melanoma.
Early detection of thin nodular melanomas has the potential to significantly impact melanoma mortality, “but we want to keep in mind that the majority of ultimately fatal melanomas are superficial spreading melanomas,” Dr. Ferris said. “That is because they are so much more prevalent. As a dermatologist, I think a lot about screening and early detection. Periodic screening is a good strategy for a slower-growing superficial spreading melanoma, but it’s not necessarily a good strategy for a rapidly growing nodular melanoma. That’s going to require better education and better access to health care.”
Self-detection of melanoma is another strategy to consider. According to Dr. Ferris, results from multiple studies suggest that about 50% of all melanomas are detected by patients, but the ones they find tend to be thicker than the ones that clinicians detect during office visits. “It would be great if we can get that number higher than 50%,” Dr. Ferris said. “If patients really understood what melanoma is, what it looks like, and when they needed to seek medical attention, perhaps we could get that over 50% and see self-detection of thinner melanomas. That’s a very low-cost intervention.”
Targeted screening efforts that stratify by risk factors and by age “makes screening more efficient and more cost-effective,” she added. She cited one analysis, which found that clinicians need to screen 606 people and conduct 25 biopsies in order to find one melanoma. “That’s very resource intensive,” she said. “However, if you only screened people 50 or older or 65 or older, the number needed to screen goes down, and because your pretest probability is higher, your number need to biopsy goes down as well. If you factor in things like a history of atypical nevi or a personal history of melanoma, those patients are at a higher risk of developing melanoma.”
Dr. Ferris closed her presentation by noting that Australia leads other countries in melanoma prevention efforts. There, the combined incidence of skin cancer is higher than the incidence of any other type of cancer. Four decades ago, Australian health officials launched SunSmart, a series of initiatives intended to reduce skin cancer. These include implementation of policies for hat wearing and shade provision in schools and at work, availability of more effective sunscreens, inclusion of sun protection items as a tax-deductible expense for outdoor workers, increased availability since the 1980s of long-sleeved sun protective swimwear, a ban on the use of indoor tanning since 2014, provision of UV forecasts in weather, and a comprehensive program of grants for community shade structures (PLoSMed. 2019 Oct 8;16[10]:e1002932).
“One approach to melanoma prevention won’t fit all,” she concluded. “We need to focus on prevention, public education to improve knowledge and self-detection.”
Dr. Ferris disclosed that she is a consultant to and an investigator for DermTech and Scibase. She is also an investigator for Castle Biosciences.
SDEF and this news organization are owned by the same parent company. Dr. Ferris spoke during a forum on cutaneous malignancies at the meeting.
LAS VEGAS – The according to data from the National Cancer Institute’s Surveillance, Epidemiology, and End Results (SEER) program.
At the Skin Disease Education Foundation’s annual Las Vegas Dermatology Seminar, Laura Korb Ferris, MD, PhD, said that SEER data project 96,480 new cases of melanoma in 2019, as well as 7,230 deaths from the disease. In 2016, SEER projected 10,130 deaths from melanoma, “so we’re actually projecting a reduction in melanoma deaths,” said Dr. Ferris, director of clinical trials at the University of Pittsburgh Medical Center’s department of dermatology. She added that the death rate from melanoma in 2016 was 2.17 per 100,000 population, a reduction from 2.69 per 100,000 population in 2011, “so it looks like melanoma mortality may be stable,” or even reduced, despite an increase in melanoma incidence.
A study of SEER data between 1989 and 2009 found that melanoma incidence is increasing across all lesion thicknesses (J Natl Cancer Inst. 2015 Nov 12. doi: 10.1093/jnci/djv294). Specifically, the incidence increased most among thin lesions, but there was a smaller increased incidence of thick melanoma. “This suggests that the overall burden of disease is truly increasing, but it is primarily stemming from an increase in T1/T2 disease,” Dr. Ferris said. “This could be due in part to increased early detection.”
Improvements in melanoma-specific survival, she continued, are likely a combination of improved management of T4 disease, a shift toward detection of thinner T1/T2 melanoma, and increased detection of T1/T2 disease.
The SEER data also showed that the incidence of fatal cases of melanoma has decreased since 1989, but only in thick melanomas. This trend may indicate a modest improvement in the management of T4 tumors. “Optimistically, I think increased detection efforts are improving survival by early detection of thin but ultimately fatal melanomas,” Dr. Ferris said. “Hopefully we are finding disease earlier and we are preventing patients from progressing to these fatal T4 melanomas.”
Disparities in melanoma-specific survival also come into play. Men have poorer survival compared with women, whites have the highest survival, and non-Hispanic whites have a better survival than Hispanic whites, Dr. Ferris said, while lower rates of survival are seen in blacks and nonblack minorities, as well as among those in high poverty and those who are separated/nonmarried. Lesion type also matters. The highest survival is seen in those with superficial spreading melanoma, while lower survival is observed in those with nodular melanoma, and acral lentiginous melanoma.
Early detection of thin nodular melanomas has the potential to significantly impact melanoma mortality, “but we want to keep in mind that the majority of ultimately fatal melanomas are superficial spreading melanomas,” Dr. Ferris said. “That is because they are so much more prevalent. As a dermatologist, I think a lot about screening and early detection. Periodic screening is a good strategy for a slower-growing superficial spreading melanoma, but it’s not necessarily a good strategy for a rapidly growing nodular melanoma. That’s going to require better education and better access to health care.”
Self-detection of melanoma is another strategy to consider. According to Dr. Ferris, results from multiple studies suggest that about 50% of all melanomas are detected by patients, but the ones they find tend to be thicker than the ones that clinicians detect during office visits. “It would be great if we can get that number higher than 50%,” Dr. Ferris said. “If patients really understood what melanoma is, what it looks like, and when they needed to seek medical attention, perhaps we could get that over 50% and see self-detection of thinner melanomas. That’s a very low-cost intervention.”
Targeted screening efforts that stratify by risk factors and by age “makes screening more efficient and more cost-effective,” she added. She cited one analysis, which found that clinicians need to screen 606 people and conduct 25 biopsies in order to find one melanoma. “That’s very resource intensive,” she said. “However, if you only screened people 50 or older or 65 or older, the number needed to screen goes down, and because your pretest probability is higher, your number need to biopsy goes down as well. If you factor in things like a history of atypical nevi or a personal history of melanoma, those patients are at a higher risk of developing melanoma.”
Dr. Ferris closed her presentation by noting that Australia leads other countries in melanoma prevention efforts. There, the combined incidence of skin cancer is higher than the incidence of any other type of cancer. Four decades ago, Australian health officials launched SunSmart, a series of initiatives intended to reduce skin cancer. These include implementation of policies for hat wearing and shade provision in schools and at work, availability of more effective sunscreens, inclusion of sun protection items as a tax-deductible expense for outdoor workers, increased availability since the 1980s of long-sleeved sun protective swimwear, a ban on the use of indoor tanning since 2014, provision of UV forecasts in weather, and a comprehensive program of grants for community shade structures (PLoSMed. 2019 Oct 8;16[10]:e1002932).
“One approach to melanoma prevention won’t fit all,” she concluded. “We need to focus on prevention, public education to improve knowledge and self-detection.”
Dr. Ferris disclosed that she is a consultant to and an investigator for DermTech and Scibase. She is also an investigator for Castle Biosciences.
SDEF and this news organization are owned by the same parent company. Dr. Ferris spoke during a forum on cutaneous malignancies at the meeting.
EXPERT ANALYSIS FROM THE SDEF LAS VEGAS DERMATOLOGY SEMINAR
Tips for helping children improve adherence to asthma treatment
NEW ORLEANS – Up to 50% of children with asthma struggle to control their condition, yet fewer than 5% of pediatric asthma is severe and truly resistant to therapy, according to Susan Laubach, MD.
Other factors may make asthma difficult to control and may be modifiable, especially nonadherence to recommended treatment. In fact, up to 70% of patients report poor adherence to recommended treatment, Dr. Laubach said at the annual meeting of the American Academy of Pediatrics.
“Barriers to adherence may be related to the treatments themselves,” she said. “These include complex treatment schedules, lack of an immediately discernible beneficial effect, adverse effects of the medication, and prohibitive costs.”
Dr. Laubach, who directs the allergy clinic at Rady Children’s Hospital in San Diego, said that clinician-related barriers also influence patient adherence to recommended treatment, including difficulty scheduling appointments or seeing the same physician, a perceived lack of empathy, or failure to discuss the family’s concerns or answer questions. Common patient-related barriers include poor understanding of how the medication may help or how to use the inhalers.
“Some families have a lack of trust in the health care system, or certain beliefs about illness or medication that may hamper motivation to adhere,” she added. “Social issues such as poverty, lack of insurance, or a chaotic home environment may make it difficult for a patient to adhere to recommended treatment.”
In 2013, researchers led by Ted Klok, MD, PhD, of Princess Amalia Children’s Clinic in the Netherlands, explored practical ways to improve treatment adherence in children with pediatric respiratory disease (Breathe. 2013;9:268-77). One of their recommendations involves “five E’s” of ensuring optimal adherence. They include:
Ensure close and repeated follow-up to help build trust and partnership. “I’ll often follow up every month until I know a patient has gained good control of his or her asthma,” said Dr. Laubach, who was not involved in developing the recommendations. “Then I’ll follow up every 3 months.”
Explore the patient’s views, beliefs, and preferences. “You can do this by inviting questions or following up on comments or remarks made about the treatment plan,” she said. “This doesn’t have to take long. You can simply ask, ‘What are you concerned might happen if your child uses an inhaled corticosteroid?’ Or, ‘What have you heard about inhaled steroids?’ ”
Express empathy using active listening techniques tailored to the patient’s needs. Consider phrasing like, “I understand what you’re saying. In a perfect world, your child would not have to use any medications. But when he can’t sleep because he’s coughing so much, the benefit of this medication probably outweighs any potential risks.”
Exercise shared decision making. For example, if the parent of one of your patients has to leave for work very early in the morning, “maybe find a way to adjust to once-daily dosing so that appropriate doses can be given at bedtime when the parent is consistently available,” Dr. Laubach said.
Evaluate adherence in a nonjudgmental fashion. Evidence suggests that most patients with asthma miss a couple of medication doses now and then. She makes it a point to ask patients, “If you’re supposed to take 14 doses a week, how many do you think you actually take?” Their response “gives me an idea about their level of adherence and it opens a discussion into why they may miss doses, so that we can find a solution to help improve adherence.”
The Childhood Asthma Management Program (CAMP) study found a significant reduction in height velocity in patients treated with budesonide, compared with placebo (N Engl J Med. 2012;367[10]:904-12). “However, most of this reduction occurred in the first year of treatment, was not additive over time, and led in average to a 1-cm difference in height as an adult,” said Dr. Laubach, who is also of the department of pediatrics at the University of California, San Diego. “So while it must be acknowledged that high-dose inhaled corticosteroids may affect growth, who do we put on inhaled corticosteroids? People who can’t breathe.”
Studies have demonstrated that the regular use of inhaled corticosteroids is associated with a decreased risk of death from asthma (N Engl J Med. 2000;343:332-6). “I suspect that most parents would trade 1 cm of height to reduce the risk of death in their child,” Dr. Laubach said.
She reported having no financial disclosures.
NEW ORLEANS – Up to 50% of children with asthma struggle to control their condition, yet fewer than 5% of pediatric asthma is severe and truly resistant to therapy, according to Susan Laubach, MD.
Other factors may make asthma difficult to control and may be modifiable, especially nonadherence to recommended treatment. In fact, up to 70% of patients report poor adherence to recommended treatment, Dr. Laubach said at the annual meeting of the American Academy of Pediatrics.
“Barriers to adherence may be related to the treatments themselves,” she said. “These include complex treatment schedules, lack of an immediately discernible beneficial effect, adverse effects of the medication, and prohibitive costs.”
Dr. Laubach, who directs the allergy clinic at Rady Children’s Hospital in San Diego, said that clinician-related barriers also influence patient adherence to recommended treatment, including difficulty scheduling appointments or seeing the same physician, a perceived lack of empathy, or failure to discuss the family’s concerns or answer questions. Common patient-related barriers include poor understanding of how the medication may help or how to use the inhalers.
“Some families have a lack of trust in the health care system, or certain beliefs about illness or medication that may hamper motivation to adhere,” she added. “Social issues such as poverty, lack of insurance, or a chaotic home environment may make it difficult for a patient to adhere to recommended treatment.”
In 2013, researchers led by Ted Klok, MD, PhD, of Princess Amalia Children’s Clinic in the Netherlands, explored practical ways to improve treatment adherence in children with pediatric respiratory disease (Breathe. 2013;9:268-77). One of their recommendations involves “five E’s” of ensuring optimal adherence. They include:
Ensure close and repeated follow-up to help build trust and partnership. “I’ll often follow up every month until I know a patient has gained good control of his or her asthma,” said Dr. Laubach, who was not involved in developing the recommendations. “Then I’ll follow up every 3 months.”
Explore the patient’s views, beliefs, and preferences. “You can do this by inviting questions or following up on comments or remarks made about the treatment plan,” she said. “This doesn’t have to take long. You can simply ask, ‘What are you concerned might happen if your child uses an inhaled corticosteroid?’ Or, ‘What have you heard about inhaled steroids?’ ”
Express empathy using active listening techniques tailored to the patient’s needs. Consider phrasing like, “I understand what you’re saying. In a perfect world, your child would not have to use any medications. But when he can’t sleep because he’s coughing so much, the benefit of this medication probably outweighs any potential risks.”
Exercise shared decision making. For example, if the parent of one of your patients has to leave for work very early in the morning, “maybe find a way to adjust to once-daily dosing so that appropriate doses can be given at bedtime when the parent is consistently available,” Dr. Laubach said.
Evaluate adherence in a nonjudgmental fashion. Evidence suggests that most patients with asthma miss a couple of medication doses now and then. She makes it a point to ask patients, “If you’re supposed to take 14 doses a week, how many do you think you actually take?” Their response “gives me an idea about their level of adherence and it opens a discussion into why they may miss doses, so that we can find a solution to help improve adherence.”
The Childhood Asthma Management Program (CAMP) study found a significant reduction in height velocity in patients treated with budesonide, compared with placebo (N Engl J Med. 2012;367[10]:904-12). “However, most of this reduction occurred in the first year of treatment, was not additive over time, and led in average to a 1-cm difference in height as an adult,” said Dr. Laubach, who is also of the department of pediatrics at the University of California, San Diego. “So while it must be acknowledged that high-dose inhaled corticosteroids may affect growth, who do we put on inhaled corticosteroids? People who can’t breathe.”
Studies have demonstrated that the regular use of inhaled corticosteroids is associated with a decreased risk of death from asthma (N Engl J Med. 2000;343:332-6). “I suspect that most parents would trade 1 cm of height to reduce the risk of death in their child,” Dr. Laubach said.
She reported having no financial disclosures.
NEW ORLEANS – Up to 50% of children with asthma struggle to control their condition, yet fewer than 5% of pediatric asthma is severe and truly resistant to therapy, according to Susan Laubach, MD.
Other factors may make asthma difficult to control and may be modifiable, especially nonadherence to recommended treatment. In fact, up to 70% of patients report poor adherence to recommended treatment, Dr. Laubach said at the annual meeting of the American Academy of Pediatrics.
“Barriers to adherence may be related to the treatments themselves,” she said. “These include complex treatment schedules, lack of an immediately discernible beneficial effect, adverse effects of the medication, and prohibitive costs.”
Dr. Laubach, who directs the allergy clinic at Rady Children’s Hospital in San Diego, said that clinician-related barriers also influence patient adherence to recommended treatment, including difficulty scheduling appointments or seeing the same physician, a perceived lack of empathy, or failure to discuss the family’s concerns or answer questions. Common patient-related barriers include poor understanding of how the medication may help or how to use the inhalers.
“Some families have a lack of trust in the health care system, or certain beliefs about illness or medication that may hamper motivation to adhere,” she added. “Social issues such as poverty, lack of insurance, or a chaotic home environment may make it difficult for a patient to adhere to recommended treatment.”
In 2013, researchers led by Ted Klok, MD, PhD, of Princess Amalia Children’s Clinic in the Netherlands, explored practical ways to improve treatment adherence in children with pediatric respiratory disease (Breathe. 2013;9:268-77). One of their recommendations involves “five E’s” of ensuring optimal adherence. They include:
Ensure close and repeated follow-up to help build trust and partnership. “I’ll often follow up every month until I know a patient has gained good control of his or her asthma,” said Dr. Laubach, who was not involved in developing the recommendations. “Then I’ll follow up every 3 months.”
Explore the patient’s views, beliefs, and preferences. “You can do this by inviting questions or following up on comments or remarks made about the treatment plan,” she said. “This doesn’t have to take long. You can simply ask, ‘What are you concerned might happen if your child uses an inhaled corticosteroid?’ Or, ‘What have you heard about inhaled steroids?’ ”
Express empathy using active listening techniques tailored to the patient’s needs. Consider phrasing like, “I understand what you’re saying. In a perfect world, your child would not have to use any medications. But when he can’t sleep because he’s coughing so much, the benefit of this medication probably outweighs any potential risks.”
Exercise shared decision making. For example, if the parent of one of your patients has to leave for work very early in the morning, “maybe find a way to adjust to once-daily dosing so that appropriate doses can be given at bedtime when the parent is consistently available,” Dr. Laubach said.
Evaluate adherence in a nonjudgmental fashion. Evidence suggests that most patients with asthma miss a couple of medication doses now and then. She makes it a point to ask patients, “If you’re supposed to take 14 doses a week, how many do you think you actually take?” Their response “gives me an idea about their level of adherence and it opens a discussion into why they may miss doses, so that we can find a solution to help improve adherence.”
The Childhood Asthma Management Program (CAMP) study found a significant reduction in height velocity in patients treated with budesonide, compared with placebo (N Engl J Med. 2012;367[10]:904-12). “However, most of this reduction occurred in the first year of treatment, was not additive over time, and led in average to a 1-cm difference in height as an adult,” said Dr. Laubach, who is also of the department of pediatrics at the University of California, San Diego. “So while it must be acknowledged that high-dose inhaled corticosteroids may affect growth, who do we put on inhaled corticosteroids? People who can’t breathe.”
Studies have demonstrated that the regular use of inhaled corticosteroids is associated with a decreased risk of death from asthma (N Engl J Med. 2000;343:332-6). “I suspect that most parents would trade 1 cm of height to reduce the risk of death in their child,” Dr. Laubach said.
She reported having no financial disclosures.
EXPERT ANALYSIS FROM AAP 2019