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Pertussis: Comparison studies show DTwP more durable
Children primed with DTaP vaccines have a weaker response to the pertussis component of the Tdap booster vaccine, compared with children primed with the whole-cell vaccine (DTwP), according to a study in Vaccine.
Michael D. Decker, MD, and colleagues conducted a study in children aged 11-12 years who had been primed with DTaP (NCT01629589) that essentially mirrored one from 6 years earlier in children primed with DTwP when it was still the more commonly used vaccine (NCT00319553). This later study randomized 211 patients to Tdap5 and 212 to Tdap3, both licensed Tdap vaccines that had been used and compared in the earlier study. The only 35% as high for Tdap5 (31.0 vs. 86.7 endotoxin units/mL, respectively; 95% confidence interval, 30%-40%) and 32% as high (44.1 vs. 136 endotoxin units/mL; 95% CI, 28%-38%) for Tdap3.
The authors noted that, because studies including children primed with DTwP are usually much older, comparisons like the one made in this study can be unreliable because of various possible confounding factors – such as changes in manufacturing process, different assays used, changing characteristics in study populations or pertussis transmission, and so on – cannot be entirely excluded. However, one of the strengths of this study, they suggested, is that “all were randomized experimental studies conducted by Sanofi Pasteur using similar procedures (including time of sera collection), and sera from all were assayed by a single laboratory (GCI) employing consistent, [Food and Drug Administration]–accepted assays.”
They did note that estimates of mean pertussis antibodies was limited by sample sizes; however, they believed the results were sufficient for the comparisons in the study.
All authors of the study were employees of Sanofi Pasteur, which funded the study and also manufactures the Tdap5 vaccine.
SOURCE: Decker MD et al. Vaccine. 2019 Jul 10. doi: 10.1016/j.vaccine.2019.07.015.
Children primed with DTaP vaccines have a weaker response to the pertussis component of the Tdap booster vaccine, compared with children primed with the whole-cell vaccine (DTwP), according to a study in Vaccine.
Michael D. Decker, MD, and colleagues conducted a study in children aged 11-12 years who had been primed with DTaP (NCT01629589) that essentially mirrored one from 6 years earlier in children primed with DTwP when it was still the more commonly used vaccine (NCT00319553). This later study randomized 211 patients to Tdap5 and 212 to Tdap3, both licensed Tdap vaccines that had been used and compared in the earlier study. The only 35% as high for Tdap5 (31.0 vs. 86.7 endotoxin units/mL, respectively; 95% confidence interval, 30%-40%) and 32% as high (44.1 vs. 136 endotoxin units/mL; 95% CI, 28%-38%) for Tdap3.
The authors noted that, because studies including children primed with DTwP are usually much older, comparisons like the one made in this study can be unreliable because of various possible confounding factors – such as changes in manufacturing process, different assays used, changing characteristics in study populations or pertussis transmission, and so on – cannot be entirely excluded. However, one of the strengths of this study, they suggested, is that “all were randomized experimental studies conducted by Sanofi Pasteur using similar procedures (including time of sera collection), and sera from all were assayed by a single laboratory (GCI) employing consistent, [Food and Drug Administration]–accepted assays.”
They did note that estimates of mean pertussis antibodies was limited by sample sizes; however, they believed the results were sufficient for the comparisons in the study.
All authors of the study were employees of Sanofi Pasteur, which funded the study and also manufactures the Tdap5 vaccine.
SOURCE: Decker MD et al. Vaccine. 2019 Jul 10. doi: 10.1016/j.vaccine.2019.07.015.
Children primed with DTaP vaccines have a weaker response to the pertussis component of the Tdap booster vaccine, compared with children primed with the whole-cell vaccine (DTwP), according to a study in Vaccine.
Michael D. Decker, MD, and colleagues conducted a study in children aged 11-12 years who had been primed with DTaP (NCT01629589) that essentially mirrored one from 6 years earlier in children primed with DTwP when it was still the more commonly used vaccine (NCT00319553). This later study randomized 211 patients to Tdap5 and 212 to Tdap3, both licensed Tdap vaccines that had been used and compared in the earlier study. The only 35% as high for Tdap5 (31.0 vs. 86.7 endotoxin units/mL, respectively; 95% confidence interval, 30%-40%) and 32% as high (44.1 vs. 136 endotoxin units/mL; 95% CI, 28%-38%) for Tdap3.
The authors noted that, because studies including children primed with DTwP are usually much older, comparisons like the one made in this study can be unreliable because of various possible confounding factors – such as changes in manufacturing process, different assays used, changing characteristics in study populations or pertussis transmission, and so on – cannot be entirely excluded. However, one of the strengths of this study, they suggested, is that “all were randomized experimental studies conducted by Sanofi Pasteur using similar procedures (including time of sera collection), and sera from all were assayed by a single laboratory (GCI) employing consistent, [Food and Drug Administration]–accepted assays.”
They did note that estimates of mean pertussis antibodies was limited by sample sizes; however, they believed the results were sufficient for the comparisons in the study.
All authors of the study were employees of Sanofi Pasteur, which funded the study and also manufactures the Tdap5 vaccine.
SOURCE: Decker MD et al. Vaccine. 2019 Jul 10. doi: 10.1016/j.vaccine.2019.07.015.
FROM VACCINE
Psychology consult for children’s skin issues can boost adherence, wellness
AUSTIN, TEX. – One day each week, Sasha D. Jaquez, PhD, visits with patients in the dermatology clinic at Dell Children’s Medical Center of Central Texas who wrestle with some aspect of their skin condition, from noncompliance to a recommended treatment regimen to fear of needles when an injection of medicine is required to keep them well.
“Our goal is to help promote the health and development of children, adolescents, and families through the use of evidence-based methods like cognitive-behavioral therapy,” said Dr. Jaquez, who is a pediatric psychologist at the University of Texas, Austin. “We do assessment and treatment of behavioral and emotional difficulties related to their skin condition or medical condition. So if they’re depressed but it’s not related to their skin condition, we will likely refer the patient to a community mental health system.”
During 1-hour visits at the dermatology clinic, Dr. Jaquez uses a mixed approach that includes cognitive-behavioral therapy and motivational interviewing to help patients and family members cope with their problematic behavior or negative thought patterns related to their skin conditions. “We do not have magic wands; we focus on the here and now,” she explained. “We focus on how to move forward in the most efficient way possible by teaching skills, practicing those skills with them in the office, and sending them home to use those skills. I don’t have 100% compliance on this, so if I notice that they’re not doing what I asked of them, we’ll have a conversation about what the barrier is. ‘What is getting in the way?’ I’ll ask. ‘Is this something you’re really wanting, or do you want a magic pill? If you want a magic pill, then our office isn’t where that’s going to come from.’ Sometimes patients aren’t ready to work on feeling better, and that is good for us to know.”
During consultations, she often talks with children and adolescents about how thoughts, feelings, and behaviors are related. She’ll use phrasing like, “The way that you think about something changes the way that you feel, and it changes the way that you act. We have control over our thoughts and behaviors, so if we think it’s going to be a bad day, it’s going to be a bad day. If we think it’s going to be a good day, then we’re going to find the positive aspects in the day and we might let those bad aspects go away. If I do something different [for my skin condition], then I’m going to feel different.”
She recalled the case of a 3-year-old boy with atopic dermatitis who was referred for excessive scratching. His mom stays at home, while dad works and travels frequently. “The parents had differing views on how to treat his medical condition. Mom wanted to do wet wraps while dad wanted to do bleach baths. Their son was getting no treatment because the parents couldn’t agree on anything. Mom noticed that her son scratches when he wants attention and when he’s angry.”
When Dr. Jaquez met with his parents, she encouraged them to agree on a plan to implement at home so that their son would gain some relief. She also advised them to ignore when their son scratches or when he gets angry. “Give him something else to do besides scratch, because if those hands are busy, he won’t be scratching. Let’s change the way this behavior happens. Let’s give him attention all the time instead of just when he’s scratching. That will work very quickly. And it did.”
She makes it a point to talk with patients and their families about living with the stress of a chronic illness like psoriasis or atopic dermatitis. “Let’s figure out, ‘How do we accept that this is how it is, and that they’re going to have to find their own ‘normal?’ ” she said. “I don’t know how many times someone comes into my office and says, ‘I just want to be normal.’ I like to ask patients, ‘what is your normal?’ These kids might have a lower quality of life than a child without a chronic illness, but we want to make sure that they’re living their lives to the fullest. You want to monitor not only adherence [to medication] but also quality of life. Sleep concerns are big. A lot of our kids might not being going to school, or they’re afraid to go to school because they get picked on because people don’t understand their skin condition.”
Dr. Jaquez acknowledged that not all dermatologists have a psychologist on staff or in their referral network, but all are capable of destigmatizing psychological and mental health issues for their patients. “Psychological comorbidities such as depression and anxiety can be associated with certain skin conditions,” she said. “Let them know that this is stressful stuff. Have discussions early, so if the time comes for a referral they won’t think you’re giving up on them. Don’t be afraid to say you have a psychologist that you want to refer to. Say, ‘I have an added team member I would love for you to meet. She’s our psychologist. She works with patients who are having difficulties.’ ”
Giving patients perceived control of their care could also help improve the behavior of concern. For example, when patients with needle phobia require an injection, ask if they would like to lay down, or sit down for the injection. “Giving them this tiny bit of control is going to help them feel more empowered,” she said.
Dr. Jaquez also recommends that clinicians pay attention to nonverbal cues and steer clear of using scare tactics to change their behavior. “Use positive behavioral strategies and try to avoid punishment. Children don’t want to hear ‘stop’ all the time. Parents are tired of saying it, and kids are tired of hearing it. We focus on praising the things that are going well. I advise parents all the time: ‘Catch them being good.’ ”
Dr. Jaquez reported having no financial disclosures.
AUSTIN, TEX. – One day each week, Sasha D. Jaquez, PhD, visits with patients in the dermatology clinic at Dell Children’s Medical Center of Central Texas who wrestle with some aspect of their skin condition, from noncompliance to a recommended treatment regimen to fear of needles when an injection of medicine is required to keep them well.
“Our goal is to help promote the health and development of children, adolescents, and families through the use of evidence-based methods like cognitive-behavioral therapy,” said Dr. Jaquez, who is a pediatric psychologist at the University of Texas, Austin. “We do assessment and treatment of behavioral and emotional difficulties related to their skin condition or medical condition. So if they’re depressed but it’s not related to their skin condition, we will likely refer the patient to a community mental health system.”
During 1-hour visits at the dermatology clinic, Dr. Jaquez uses a mixed approach that includes cognitive-behavioral therapy and motivational interviewing to help patients and family members cope with their problematic behavior or negative thought patterns related to their skin conditions. “We do not have magic wands; we focus on the here and now,” she explained. “We focus on how to move forward in the most efficient way possible by teaching skills, practicing those skills with them in the office, and sending them home to use those skills. I don’t have 100% compliance on this, so if I notice that they’re not doing what I asked of them, we’ll have a conversation about what the barrier is. ‘What is getting in the way?’ I’ll ask. ‘Is this something you’re really wanting, or do you want a magic pill? If you want a magic pill, then our office isn’t where that’s going to come from.’ Sometimes patients aren’t ready to work on feeling better, and that is good for us to know.”
During consultations, she often talks with children and adolescents about how thoughts, feelings, and behaviors are related. She’ll use phrasing like, “The way that you think about something changes the way that you feel, and it changes the way that you act. We have control over our thoughts and behaviors, so if we think it’s going to be a bad day, it’s going to be a bad day. If we think it’s going to be a good day, then we’re going to find the positive aspects in the day and we might let those bad aspects go away. If I do something different [for my skin condition], then I’m going to feel different.”
She recalled the case of a 3-year-old boy with atopic dermatitis who was referred for excessive scratching. His mom stays at home, while dad works and travels frequently. “The parents had differing views on how to treat his medical condition. Mom wanted to do wet wraps while dad wanted to do bleach baths. Their son was getting no treatment because the parents couldn’t agree on anything. Mom noticed that her son scratches when he wants attention and when he’s angry.”
When Dr. Jaquez met with his parents, she encouraged them to agree on a plan to implement at home so that their son would gain some relief. She also advised them to ignore when their son scratches or when he gets angry. “Give him something else to do besides scratch, because if those hands are busy, he won’t be scratching. Let’s change the way this behavior happens. Let’s give him attention all the time instead of just when he’s scratching. That will work very quickly. And it did.”
She makes it a point to talk with patients and their families about living with the stress of a chronic illness like psoriasis or atopic dermatitis. “Let’s figure out, ‘How do we accept that this is how it is, and that they’re going to have to find their own ‘normal?’ ” she said. “I don’t know how many times someone comes into my office and says, ‘I just want to be normal.’ I like to ask patients, ‘what is your normal?’ These kids might have a lower quality of life than a child without a chronic illness, but we want to make sure that they’re living their lives to the fullest. You want to monitor not only adherence [to medication] but also quality of life. Sleep concerns are big. A lot of our kids might not being going to school, or they’re afraid to go to school because they get picked on because people don’t understand their skin condition.”
Dr. Jaquez acknowledged that not all dermatologists have a psychologist on staff or in their referral network, but all are capable of destigmatizing psychological and mental health issues for their patients. “Psychological comorbidities such as depression and anxiety can be associated with certain skin conditions,” she said. “Let them know that this is stressful stuff. Have discussions early, so if the time comes for a referral they won’t think you’re giving up on them. Don’t be afraid to say you have a psychologist that you want to refer to. Say, ‘I have an added team member I would love for you to meet. She’s our psychologist. She works with patients who are having difficulties.’ ”
Giving patients perceived control of their care could also help improve the behavior of concern. For example, when patients with needle phobia require an injection, ask if they would like to lay down, or sit down for the injection. “Giving them this tiny bit of control is going to help them feel more empowered,” she said.
Dr. Jaquez also recommends that clinicians pay attention to nonverbal cues and steer clear of using scare tactics to change their behavior. “Use positive behavioral strategies and try to avoid punishment. Children don’t want to hear ‘stop’ all the time. Parents are tired of saying it, and kids are tired of hearing it. We focus on praising the things that are going well. I advise parents all the time: ‘Catch them being good.’ ”
Dr. Jaquez reported having no financial disclosures.
AUSTIN, TEX. – One day each week, Sasha D. Jaquez, PhD, visits with patients in the dermatology clinic at Dell Children’s Medical Center of Central Texas who wrestle with some aspect of their skin condition, from noncompliance to a recommended treatment regimen to fear of needles when an injection of medicine is required to keep them well.
“Our goal is to help promote the health and development of children, adolescents, and families through the use of evidence-based methods like cognitive-behavioral therapy,” said Dr. Jaquez, who is a pediatric psychologist at the University of Texas, Austin. “We do assessment and treatment of behavioral and emotional difficulties related to their skin condition or medical condition. So if they’re depressed but it’s not related to their skin condition, we will likely refer the patient to a community mental health system.”
During 1-hour visits at the dermatology clinic, Dr. Jaquez uses a mixed approach that includes cognitive-behavioral therapy and motivational interviewing to help patients and family members cope with their problematic behavior or negative thought patterns related to their skin conditions. “We do not have magic wands; we focus on the here and now,” she explained. “We focus on how to move forward in the most efficient way possible by teaching skills, practicing those skills with them in the office, and sending them home to use those skills. I don’t have 100% compliance on this, so if I notice that they’re not doing what I asked of them, we’ll have a conversation about what the barrier is. ‘What is getting in the way?’ I’ll ask. ‘Is this something you’re really wanting, or do you want a magic pill? If you want a magic pill, then our office isn’t where that’s going to come from.’ Sometimes patients aren’t ready to work on feeling better, and that is good for us to know.”
During consultations, she often talks with children and adolescents about how thoughts, feelings, and behaviors are related. She’ll use phrasing like, “The way that you think about something changes the way that you feel, and it changes the way that you act. We have control over our thoughts and behaviors, so if we think it’s going to be a bad day, it’s going to be a bad day. If we think it’s going to be a good day, then we’re going to find the positive aspects in the day and we might let those bad aspects go away. If I do something different [for my skin condition], then I’m going to feel different.”
She recalled the case of a 3-year-old boy with atopic dermatitis who was referred for excessive scratching. His mom stays at home, while dad works and travels frequently. “The parents had differing views on how to treat his medical condition. Mom wanted to do wet wraps while dad wanted to do bleach baths. Their son was getting no treatment because the parents couldn’t agree on anything. Mom noticed that her son scratches when he wants attention and when he’s angry.”
When Dr. Jaquez met with his parents, she encouraged them to agree on a plan to implement at home so that their son would gain some relief. She also advised them to ignore when their son scratches or when he gets angry. “Give him something else to do besides scratch, because if those hands are busy, he won’t be scratching. Let’s change the way this behavior happens. Let’s give him attention all the time instead of just when he’s scratching. That will work very quickly. And it did.”
She makes it a point to talk with patients and their families about living with the stress of a chronic illness like psoriasis or atopic dermatitis. “Let’s figure out, ‘How do we accept that this is how it is, and that they’re going to have to find their own ‘normal?’ ” she said. “I don’t know how many times someone comes into my office and says, ‘I just want to be normal.’ I like to ask patients, ‘what is your normal?’ These kids might have a lower quality of life than a child without a chronic illness, but we want to make sure that they’re living their lives to the fullest. You want to monitor not only adherence [to medication] but also quality of life. Sleep concerns are big. A lot of our kids might not being going to school, or they’re afraid to go to school because they get picked on because people don’t understand their skin condition.”
Dr. Jaquez acknowledged that not all dermatologists have a psychologist on staff or in their referral network, but all are capable of destigmatizing psychological and mental health issues for their patients. “Psychological comorbidities such as depression and anxiety can be associated with certain skin conditions,” she said. “Let them know that this is stressful stuff. Have discussions early, so if the time comes for a referral they won’t think you’re giving up on them. Don’t be afraid to say you have a psychologist that you want to refer to. Say, ‘I have an added team member I would love for you to meet. She’s our psychologist. She works with patients who are having difficulties.’ ”
Giving patients perceived control of their care could also help improve the behavior of concern. For example, when patients with needle phobia require an injection, ask if they would like to lay down, or sit down for the injection. “Giving them this tiny bit of control is going to help them feel more empowered,” she said.
Dr. Jaquez also recommends that clinicians pay attention to nonverbal cues and steer clear of using scare tactics to change their behavior. “Use positive behavioral strategies and try to avoid punishment. Children don’t want to hear ‘stop’ all the time. Parents are tired of saying it, and kids are tired of hearing it. We focus on praising the things that are going well. I advise parents all the time: ‘Catch them being good.’ ”
Dr. Jaquez reported having no financial disclosures.
EXPERT ANALYSIS FROM SPD 2019
Biologics for pediatric psoriasis don’t increase infection risk
AUSTIN, TEX. – Among children with psoriasis, there appears to be no strong evidence that biologic immunomodulating drugs increase the 6-month risk of serious infections, compared with systemic nonbiologics or phototherapy, according to results from the largest population-based study of its kind to date.
However, children with psoriasis face a 64% increased risk of infection, compared with risk-matched pediatric patients without the disease.
“We know that pediatric psoriasis affects up to 1.3% of children, and we know that is associated with multiple potential comorbidities and that it has a significant impact on quality of life for children affected,” lead study author Maria Schneeweiss, MD, said at the annual meeting of the Society for Pediatric Dermatology. “Increasingly, we see that biologic and nonbiologic systemic agents are used to treat moderate to severe pediatric psoriasis. While we have a lot of experience in adult psoriasis and a lot of comparative safety studies of these drugs in adult psoriasis, there are very few population-based studies on the safety of these systemic agents for treating pediatric psoriasis.”
In an effort to evaluate the 6-month risk of serious bacterial and opportunistic infections in children with psoriasis treated with systemic immunomodulatory medications, Dr. Schneeweiss and Joseph F. Merola, MD, of the department of dermatology at Brigham and Women’s Hospital, Boston, and Jennifer Huang, MD, of Boston Children’s Hospital drew from longitudinal, patient-level U.S. claims data in the MarketScan database between 2003 and 2017. They limited the analysis to patients younger than age 18; those who had a recorded diagnosis of psoriasis; and those who were treated with biologics, nonbiologic immunomodulatory agents, or phototherapy. The researchers used hospital discharge diagnoses to compute the risk of serious bacterial and opportunistic infections, and propensity score matching to determine relative risks.
A total of 54,355 children with psoriasis were identified in the database. Before propensity score matching, 635 patients initiated biologic therapy, 919 initiated nonbiologic systemic agents, and 2,537 initiated phototherapy. Their mean age was 12-14 years and slightly more than half were female. In nonbiologic initiators, the 6-month risk of serious infections was 4.75 per 1,000 patients, while in biologic initiators it was 5.44 per 1,000 patients, resulting in a propensity score–matched ratio of 0.60. There was no statistically significant increased risk when the use of nonbiologics was compared with the use of phototherapy.
Independent of treatment, the risk of infection among psoriasis patients was 1.1 per 1,000 patients, which was 60% higher than matched pediatric patients without psoriasis (risk ratio, 1.64).
“When treating pediatric patients with psoriasis, clinicians should remain mindful that the presence of psoriasis itself may increase the risk of infection in children and adolescents, independent of treatment, but that biologic immunomodulatory agents do not further increase that risk,” Dr. Schneeweiss said in an interview. “Our findings suggest that, while there may be an increased risk of certain infections based on the presence of psoriasis alone, all appropriate treatment options should be discussed with patients in shared decision making with their physician. Patients should understand the risks, benefits, and alternatives to any treatment option but not necessarily be restricted as such and have access to newer, targeted and highly effective therapy as appropriate to each individual case.”
She added that, based on the National Psoriasis Foundation guidance of treat-to-target strategies, “our pediatric patients should be offered the same level of disease control as all psoriasis patients.”
She acknowledged certain limitations of the analysis, including the inability to stratify by disease severity and to determine specific doses of medication used.
The study was funded by the Brigham and Women’s Hospital departments of dermatology and medicine. Dr. Schneeweiss and Dr. Huang reported having no financial disclosures. Dr. Merola reported that he has served as a consultant and/or investigator for numerous pharmaceutical companies.
AUSTIN, TEX. – Among children with psoriasis, there appears to be no strong evidence that biologic immunomodulating drugs increase the 6-month risk of serious infections, compared with systemic nonbiologics or phototherapy, according to results from the largest population-based study of its kind to date.
However, children with psoriasis face a 64% increased risk of infection, compared with risk-matched pediatric patients without the disease.
“We know that pediatric psoriasis affects up to 1.3% of children, and we know that is associated with multiple potential comorbidities and that it has a significant impact on quality of life for children affected,” lead study author Maria Schneeweiss, MD, said at the annual meeting of the Society for Pediatric Dermatology. “Increasingly, we see that biologic and nonbiologic systemic agents are used to treat moderate to severe pediatric psoriasis. While we have a lot of experience in adult psoriasis and a lot of comparative safety studies of these drugs in adult psoriasis, there are very few population-based studies on the safety of these systemic agents for treating pediatric psoriasis.”
In an effort to evaluate the 6-month risk of serious bacterial and opportunistic infections in children with psoriasis treated with systemic immunomodulatory medications, Dr. Schneeweiss and Joseph F. Merola, MD, of the department of dermatology at Brigham and Women’s Hospital, Boston, and Jennifer Huang, MD, of Boston Children’s Hospital drew from longitudinal, patient-level U.S. claims data in the MarketScan database between 2003 and 2017. They limited the analysis to patients younger than age 18; those who had a recorded diagnosis of psoriasis; and those who were treated with biologics, nonbiologic immunomodulatory agents, or phototherapy. The researchers used hospital discharge diagnoses to compute the risk of serious bacterial and opportunistic infections, and propensity score matching to determine relative risks.
A total of 54,355 children with psoriasis were identified in the database. Before propensity score matching, 635 patients initiated biologic therapy, 919 initiated nonbiologic systemic agents, and 2,537 initiated phototherapy. Their mean age was 12-14 years and slightly more than half were female. In nonbiologic initiators, the 6-month risk of serious infections was 4.75 per 1,000 patients, while in biologic initiators it was 5.44 per 1,000 patients, resulting in a propensity score–matched ratio of 0.60. There was no statistically significant increased risk when the use of nonbiologics was compared with the use of phototherapy.
Independent of treatment, the risk of infection among psoriasis patients was 1.1 per 1,000 patients, which was 60% higher than matched pediatric patients without psoriasis (risk ratio, 1.64).
“When treating pediatric patients with psoriasis, clinicians should remain mindful that the presence of psoriasis itself may increase the risk of infection in children and adolescents, independent of treatment, but that biologic immunomodulatory agents do not further increase that risk,” Dr. Schneeweiss said in an interview. “Our findings suggest that, while there may be an increased risk of certain infections based on the presence of psoriasis alone, all appropriate treatment options should be discussed with patients in shared decision making with their physician. Patients should understand the risks, benefits, and alternatives to any treatment option but not necessarily be restricted as such and have access to newer, targeted and highly effective therapy as appropriate to each individual case.”
She added that, based on the National Psoriasis Foundation guidance of treat-to-target strategies, “our pediatric patients should be offered the same level of disease control as all psoriasis patients.”
She acknowledged certain limitations of the analysis, including the inability to stratify by disease severity and to determine specific doses of medication used.
The study was funded by the Brigham and Women’s Hospital departments of dermatology and medicine. Dr. Schneeweiss and Dr. Huang reported having no financial disclosures. Dr. Merola reported that he has served as a consultant and/or investigator for numerous pharmaceutical companies.
AUSTIN, TEX. – Among children with psoriasis, there appears to be no strong evidence that biologic immunomodulating drugs increase the 6-month risk of serious infections, compared with systemic nonbiologics or phototherapy, according to results from the largest population-based study of its kind to date.
However, children with psoriasis face a 64% increased risk of infection, compared with risk-matched pediatric patients without the disease.
“We know that pediatric psoriasis affects up to 1.3% of children, and we know that is associated with multiple potential comorbidities and that it has a significant impact on quality of life for children affected,” lead study author Maria Schneeweiss, MD, said at the annual meeting of the Society for Pediatric Dermatology. “Increasingly, we see that biologic and nonbiologic systemic agents are used to treat moderate to severe pediatric psoriasis. While we have a lot of experience in adult psoriasis and a lot of comparative safety studies of these drugs in adult psoriasis, there are very few population-based studies on the safety of these systemic agents for treating pediatric psoriasis.”
In an effort to evaluate the 6-month risk of serious bacterial and opportunistic infections in children with psoriasis treated with systemic immunomodulatory medications, Dr. Schneeweiss and Joseph F. Merola, MD, of the department of dermatology at Brigham and Women’s Hospital, Boston, and Jennifer Huang, MD, of Boston Children’s Hospital drew from longitudinal, patient-level U.S. claims data in the MarketScan database between 2003 and 2017. They limited the analysis to patients younger than age 18; those who had a recorded diagnosis of psoriasis; and those who were treated with biologics, nonbiologic immunomodulatory agents, or phototherapy. The researchers used hospital discharge diagnoses to compute the risk of serious bacterial and opportunistic infections, and propensity score matching to determine relative risks.
A total of 54,355 children with psoriasis were identified in the database. Before propensity score matching, 635 patients initiated biologic therapy, 919 initiated nonbiologic systemic agents, and 2,537 initiated phototherapy. Their mean age was 12-14 years and slightly more than half were female. In nonbiologic initiators, the 6-month risk of serious infections was 4.75 per 1,000 patients, while in biologic initiators it was 5.44 per 1,000 patients, resulting in a propensity score–matched ratio of 0.60. There was no statistically significant increased risk when the use of nonbiologics was compared with the use of phototherapy.
Independent of treatment, the risk of infection among psoriasis patients was 1.1 per 1,000 patients, which was 60% higher than matched pediatric patients without psoriasis (risk ratio, 1.64).
“When treating pediatric patients with psoriasis, clinicians should remain mindful that the presence of psoriasis itself may increase the risk of infection in children and adolescents, independent of treatment, but that biologic immunomodulatory agents do not further increase that risk,” Dr. Schneeweiss said in an interview. “Our findings suggest that, while there may be an increased risk of certain infections based on the presence of psoriasis alone, all appropriate treatment options should be discussed with patients in shared decision making with their physician. Patients should understand the risks, benefits, and alternatives to any treatment option but not necessarily be restricted as such and have access to newer, targeted and highly effective therapy as appropriate to each individual case.”
She added that, based on the National Psoriasis Foundation guidance of treat-to-target strategies, “our pediatric patients should be offered the same level of disease control as all psoriasis patients.”
She acknowledged certain limitations of the analysis, including the inability to stratify by disease severity and to determine specific doses of medication used.
The study was funded by the Brigham and Women’s Hospital departments of dermatology and medicine. Dr. Schneeweiss and Dr. Huang reported having no financial disclosures. Dr. Merola reported that he has served as a consultant and/or investigator for numerous pharmaceutical companies.
REPORTING FROM SPD 2019
Pentavalent DTaP-Hb-Hib vaccine is found noninferior to comparator
The to a similar, commercially available vaccine in infants, according to a study in Vaccine.
In this phase 3, randomized, single-blind, multicenter, noninferiority study, Sai Krishna Susarla of Human Biologicals Institute, which developed the test vaccine, and colleagues randomized 405 infants aged 6-8 weeks 2:1 to three doses of either the test vaccine or the comparator, Pentavac SD (Serum Institute of India). The percentages of seroconversion for diphtheria, pertussis, hepatitis B, and Hib were 98.44%, 92.61%, 99.22%, and 95.72% for the test vaccine, respectively, and 90.0%, 89.23%, 100%, and 90.77% for the comparator. In keeping with some previous studies, the percentages for tetanus were low at 50.97% with the test vaccine and 30.23% with the comparator. Despite the low seroconversion for tetanus, the test vaccine was determined to be noninferior to the comparator for it and the other four diseases it targets. The safety profile was also found to be comparable.
Although the study’s major limitation is that it was conducted in only one country, “the strength of the study is considered to be good” because “compliance to protocol was good, deviations were minimal, and ... very few subjects were withdrawn,” the researchers wrote.
Some of the researchers were employees of the sponsor, Human Biologicals Institute, which developed the test vaccine. Other researchers had no financial interest in the test vaccine and were unrelated to the sponsor, but did receive research grants for conducting the study at their respective sites.
SOURCE: Susarla SK et al. Vaccine. 2019 Jul 19. doi: 10.1016/j.vaccine.2019.06.067.
The to a similar, commercially available vaccine in infants, according to a study in Vaccine.
In this phase 3, randomized, single-blind, multicenter, noninferiority study, Sai Krishna Susarla of Human Biologicals Institute, which developed the test vaccine, and colleagues randomized 405 infants aged 6-8 weeks 2:1 to three doses of either the test vaccine or the comparator, Pentavac SD (Serum Institute of India). The percentages of seroconversion for diphtheria, pertussis, hepatitis B, and Hib were 98.44%, 92.61%, 99.22%, and 95.72% for the test vaccine, respectively, and 90.0%, 89.23%, 100%, and 90.77% for the comparator. In keeping with some previous studies, the percentages for tetanus were low at 50.97% with the test vaccine and 30.23% with the comparator. Despite the low seroconversion for tetanus, the test vaccine was determined to be noninferior to the comparator for it and the other four diseases it targets. The safety profile was also found to be comparable.
Although the study’s major limitation is that it was conducted in only one country, “the strength of the study is considered to be good” because “compliance to protocol was good, deviations were minimal, and ... very few subjects were withdrawn,” the researchers wrote.
Some of the researchers were employees of the sponsor, Human Biologicals Institute, which developed the test vaccine. Other researchers had no financial interest in the test vaccine and were unrelated to the sponsor, but did receive research grants for conducting the study at their respective sites.
SOURCE: Susarla SK et al. Vaccine. 2019 Jul 19. doi: 10.1016/j.vaccine.2019.06.067.
The to a similar, commercially available vaccine in infants, according to a study in Vaccine.
In this phase 3, randomized, single-blind, multicenter, noninferiority study, Sai Krishna Susarla of Human Biologicals Institute, which developed the test vaccine, and colleagues randomized 405 infants aged 6-8 weeks 2:1 to three doses of either the test vaccine or the comparator, Pentavac SD (Serum Institute of India). The percentages of seroconversion for diphtheria, pertussis, hepatitis B, and Hib were 98.44%, 92.61%, 99.22%, and 95.72% for the test vaccine, respectively, and 90.0%, 89.23%, 100%, and 90.77% for the comparator. In keeping with some previous studies, the percentages for tetanus were low at 50.97% with the test vaccine and 30.23% with the comparator. Despite the low seroconversion for tetanus, the test vaccine was determined to be noninferior to the comparator for it and the other four diseases it targets. The safety profile was also found to be comparable.
Although the study’s major limitation is that it was conducted in only one country, “the strength of the study is considered to be good” because “compliance to protocol was good, deviations were minimal, and ... very few subjects were withdrawn,” the researchers wrote.
Some of the researchers were employees of the sponsor, Human Biologicals Institute, which developed the test vaccine. Other researchers had no financial interest in the test vaccine and were unrelated to the sponsor, but did receive research grants for conducting the study at their respective sites.
SOURCE: Susarla SK et al. Vaccine. 2019 Jul 19. doi: 10.1016/j.vaccine.2019.06.067.
FROM VACCINE
BRCA2 mutations linked to childhood NHL
Pediatric non-Hodgkin lymphomas should be added to the list of cancers associated with BRCA2 mutations, and survivors of childhood NHL should be considered for genetic counseling, investigators suggest.
Among 1,380 survivors of childhood lymphomas, those who were retrospectively found to be carriers of BRCA2 mutations had a fivefold higher risk for non-Hodgkin lymphoma than controls without cancer, reported Zhaoming Wang, PhD, and colleagues from St. Jude Children’s Research Hospital in Memphis.
“Genetic counseling and the option of BRCA2 genetic testing should be offered to survivors of pediatric or adolescent non–Hodgkin lymphoma, particularly those with a family history of BRCA2-associated cancers,” they wrote in JAMA Oncology.
The investigators had previously reported that BRCA2 was the third-most frequently mutated gene among 3006 survivors of childhood cancers, with the highest number of mutations seen in lymphoma survivors. In that study, 7 of 586 survivors of Hodgkin and non-Hodgkin lymphoma (1.2%) were found to carry BRCA2 mutations.
In the current study, the investigators performed germline whole-genome sequencing on samples from 815 survivors of childhood Hodgkin lymphoma and 748 survivors of non-Hodgkin lymphoma from the St. Jude Lifetime Cohort and Childhood Cancer Survivor studies and compared the data with those of controls without cancer from the Genome Aggregation Database.
They identified mutations in five Hodgkin lymphoma survivors (0.6%) and eight non-Hodgkin lymphoma survivors.
A comparison of cancer risk among lymphoma survivors and controls found that non-Hodgkin lymphoma survivors and BRCA2 carriers had an odds ratio for cancer of 5.0, compared with controls who were not BRCA2 carriers (P less than .001). Among Hodgkin lymphoma survivors the OR for carriers vs. controls was 2.1, but was not statistically significant.
Available family histories for seven of the eight non-Hodgkin lymphoma BRCA2 mutation carriers showed histories of BRCA2-linked cancers, including breast, prostate, and pancreas tumors and malignant melanoma.
“Survivors whose test results are positive for mutation should be offered surveillance for BRCA2-associated cancers, such as breast and ovarian, and counseled about cancer risk–reducing strategies. Currently, it remains unclear whether surveillance for non–Hodgkin lymphoma is associated with early detection of lymphomas or with other medical advantages,” the investigators wrote.
“This study was funded by a grant to St Jude Children’s Research Hospital from the American Lebanese Syrian Associated Charities and by grants to St Jude Children’s Research Hospital from the National Institutes of Health. The authors reported having no conflicts of interest.
SOURCE: Wang Z et al. JAMA Oncology. 2019 Jul 25. doi: 10.1001/jamaoncol.2019.2203.
Pediatric non-Hodgkin lymphomas should be added to the list of cancers associated with BRCA2 mutations, and survivors of childhood NHL should be considered for genetic counseling, investigators suggest.
Among 1,380 survivors of childhood lymphomas, those who were retrospectively found to be carriers of BRCA2 mutations had a fivefold higher risk for non-Hodgkin lymphoma than controls without cancer, reported Zhaoming Wang, PhD, and colleagues from St. Jude Children’s Research Hospital in Memphis.
“Genetic counseling and the option of BRCA2 genetic testing should be offered to survivors of pediatric or adolescent non–Hodgkin lymphoma, particularly those with a family history of BRCA2-associated cancers,” they wrote in JAMA Oncology.
The investigators had previously reported that BRCA2 was the third-most frequently mutated gene among 3006 survivors of childhood cancers, with the highest number of mutations seen in lymphoma survivors. In that study, 7 of 586 survivors of Hodgkin and non-Hodgkin lymphoma (1.2%) were found to carry BRCA2 mutations.
In the current study, the investigators performed germline whole-genome sequencing on samples from 815 survivors of childhood Hodgkin lymphoma and 748 survivors of non-Hodgkin lymphoma from the St. Jude Lifetime Cohort and Childhood Cancer Survivor studies and compared the data with those of controls without cancer from the Genome Aggregation Database.
They identified mutations in five Hodgkin lymphoma survivors (0.6%) and eight non-Hodgkin lymphoma survivors.
A comparison of cancer risk among lymphoma survivors and controls found that non-Hodgkin lymphoma survivors and BRCA2 carriers had an odds ratio for cancer of 5.0, compared with controls who were not BRCA2 carriers (P less than .001). Among Hodgkin lymphoma survivors the OR for carriers vs. controls was 2.1, but was not statistically significant.
Available family histories for seven of the eight non-Hodgkin lymphoma BRCA2 mutation carriers showed histories of BRCA2-linked cancers, including breast, prostate, and pancreas tumors and malignant melanoma.
“Survivors whose test results are positive for mutation should be offered surveillance for BRCA2-associated cancers, such as breast and ovarian, and counseled about cancer risk–reducing strategies. Currently, it remains unclear whether surveillance for non–Hodgkin lymphoma is associated with early detection of lymphomas or with other medical advantages,” the investigators wrote.
“This study was funded by a grant to St Jude Children’s Research Hospital from the American Lebanese Syrian Associated Charities and by grants to St Jude Children’s Research Hospital from the National Institutes of Health. The authors reported having no conflicts of interest.
SOURCE: Wang Z et al. JAMA Oncology. 2019 Jul 25. doi: 10.1001/jamaoncol.2019.2203.
Pediatric non-Hodgkin lymphomas should be added to the list of cancers associated with BRCA2 mutations, and survivors of childhood NHL should be considered for genetic counseling, investigators suggest.
Among 1,380 survivors of childhood lymphomas, those who were retrospectively found to be carriers of BRCA2 mutations had a fivefold higher risk for non-Hodgkin lymphoma than controls without cancer, reported Zhaoming Wang, PhD, and colleagues from St. Jude Children’s Research Hospital in Memphis.
“Genetic counseling and the option of BRCA2 genetic testing should be offered to survivors of pediatric or adolescent non–Hodgkin lymphoma, particularly those with a family history of BRCA2-associated cancers,” they wrote in JAMA Oncology.
The investigators had previously reported that BRCA2 was the third-most frequently mutated gene among 3006 survivors of childhood cancers, with the highest number of mutations seen in lymphoma survivors. In that study, 7 of 586 survivors of Hodgkin and non-Hodgkin lymphoma (1.2%) were found to carry BRCA2 mutations.
In the current study, the investigators performed germline whole-genome sequencing on samples from 815 survivors of childhood Hodgkin lymphoma and 748 survivors of non-Hodgkin lymphoma from the St. Jude Lifetime Cohort and Childhood Cancer Survivor studies and compared the data with those of controls without cancer from the Genome Aggregation Database.
They identified mutations in five Hodgkin lymphoma survivors (0.6%) and eight non-Hodgkin lymphoma survivors.
A comparison of cancer risk among lymphoma survivors and controls found that non-Hodgkin lymphoma survivors and BRCA2 carriers had an odds ratio for cancer of 5.0, compared with controls who were not BRCA2 carriers (P less than .001). Among Hodgkin lymphoma survivors the OR for carriers vs. controls was 2.1, but was not statistically significant.
Available family histories for seven of the eight non-Hodgkin lymphoma BRCA2 mutation carriers showed histories of BRCA2-linked cancers, including breast, prostate, and pancreas tumors and malignant melanoma.
“Survivors whose test results are positive for mutation should be offered surveillance for BRCA2-associated cancers, such as breast and ovarian, and counseled about cancer risk–reducing strategies. Currently, it remains unclear whether surveillance for non–Hodgkin lymphoma is associated with early detection of lymphomas or with other medical advantages,” the investigators wrote.
“This study was funded by a grant to St Jude Children’s Research Hospital from the American Lebanese Syrian Associated Charities and by grants to St Jude Children’s Research Hospital from the National Institutes of Health. The authors reported having no conflicts of interest.
SOURCE: Wang Z et al. JAMA Oncology. 2019 Jul 25. doi: 10.1001/jamaoncol.2019.2203.
FROM JAMA ONCOLOGY
FDA approves Baqsimi nasal powder for emergency hypoglycemia treatment
in patients aged 4 years and older.
Injectable glucagon has been approved in the United States for several decades.
The safety and efficacy of the Baqsimi powder was assessed in two studies with adults with diabetes and one with pediatric patients. In all three studies, a single dose of Baqsimi was compared with a single dose of glucagon injection, and Baqsimi adequately raised blood sugar levels in response to insulin-induced hypoglycemia.
The most common adverse events associated with Baqsimi include nausea, vomiting, headache, upper respiratory tract irritation, watery eyes, redness of eyes, and itchiness. The safety profile is similar to that of injectable glucagon, with the addition of nasal- and eye-related symptoms because of the method of delivery.
“There are many products on the market for those who need insulin, but until now, people suffering from a severe hypoglycemic episode had to be treated with a glucagon injection that first had to be mixed in a several-step process. This new way to administer glucagon may simplify the process, which can be critical during an episode, especially since the patient may have lost consciousness or may be having a seizure. In those situations, we want the process to treat the suffering person to be as simple as possible,” Janet Woodcock, MD, director of the FDA’s Center for Drug Evaluation and Research, said in the press release.
Find the full press release on the FDA website.
in patients aged 4 years and older.
Injectable glucagon has been approved in the United States for several decades.
The safety and efficacy of the Baqsimi powder was assessed in two studies with adults with diabetes and one with pediatric patients. In all three studies, a single dose of Baqsimi was compared with a single dose of glucagon injection, and Baqsimi adequately raised blood sugar levels in response to insulin-induced hypoglycemia.
The most common adverse events associated with Baqsimi include nausea, vomiting, headache, upper respiratory tract irritation, watery eyes, redness of eyes, and itchiness. The safety profile is similar to that of injectable glucagon, with the addition of nasal- and eye-related symptoms because of the method of delivery.
“There are many products on the market for those who need insulin, but until now, people suffering from a severe hypoglycemic episode had to be treated with a glucagon injection that first had to be mixed in a several-step process. This new way to administer glucagon may simplify the process, which can be critical during an episode, especially since the patient may have lost consciousness or may be having a seizure. In those situations, we want the process to treat the suffering person to be as simple as possible,” Janet Woodcock, MD, director of the FDA’s Center for Drug Evaluation and Research, said in the press release.
Find the full press release on the FDA website.
in patients aged 4 years and older.
Injectable glucagon has been approved in the United States for several decades.
The safety and efficacy of the Baqsimi powder was assessed in two studies with adults with diabetes and one with pediatric patients. In all three studies, a single dose of Baqsimi was compared with a single dose of glucagon injection, and Baqsimi adequately raised blood sugar levels in response to insulin-induced hypoglycemia.
The most common adverse events associated with Baqsimi include nausea, vomiting, headache, upper respiratory tract irritation, watery eyes, redness of eyes, and itchiness. The safety profile is similar to that of injectable glucagon, with the addition of nasal- and eye-related symptoms because of the method of delivery.
“There are many products on the market for those who need insulin, but until now, people suffering from a severe hypoglycemic episode had to be treated with a glucagon injection that first had to be mixed in a several-step process. This new way to administer glucagon may simplify the process, which can be critical during an episode, especially since the patient may have lost consciousness or may be having a seizure. In those situations, we want the process to treat the suffering person to be as simple as possible,” Janet Woodcock, MD, director of the FDA’s Center for Drug Evaluation and Research, said in the press release.
Find the full press release on the FDA website.
NIH launches 5-year, $10 million study on acute flaccid myelitis
Researchers at the University of Alabama at Birmingham will lead a 5-year, federally-funded study of acute flaccid myelitis (AFM) – a rare pediatric neurologic disease.
The National Institute of Allergy and Infectious Diseases (NIAID) awarded the $10 million grant to primary investigator David Kimberlin, MD, a UAB professor of pediatrics. Carlos Pardo-Villamizar, MD, professor of neurology and pathology at Johns Hopkins University, Baltimore, is the co-principal investigator.
The university will organize and implement the international, multisite study. Its primary goal is to examine the incidence and distribution of AFM, and its pathogenesis and progression. Enrollment is expected to commence next fall. Investigators will enroll children with symptoms of AFM and follow them for 1 year. Household contacts of the subjects will serve as comparators.
In addition to collecting data about risk factors and disease progression, the researchers will collect clinical specimens, including blood and cerebrospinal fluid. More details about the design and study sites will be released then, according to a press statement issued by NIAID.
AFM targets spinal nerves and often develops after a mild respiratory illness. The disease mounted a global epidemic comeback in 2014, primarily affecting children; it has occurred concurrently with enterovirus outbreaks.
“Growing epidemiological evidence suggests that enterovirus-D68 [EV-D68] could play a role,” the statement noted. “Most people who become infected with EV-D68 are asymptomatic or experience mild, cold-like symptoms. Researchers and physicians are working to understand if there is a connection between these viral outbreaks and AFM, and if so, why some children but not others experience this sudden muscle weakness and paralysis.”
The study will draw on the expertise of the AFM Task Force, established last fall. The group comprises physicians, scientists, and public health experts from diverse disciplines and institutions who will assist in the ongoing investigation.
The AFM natural history study is funded under contract HHSN272201600018C.
Researchers at the University of Alabama at Birmingham will lead a 5-year, federally-funded study of acute flaccid myelitis (AFM) – a rare pediatric neurologic disease.
The National Institute of Allergy and Infectious Diseases (NIAID) awarded the $10 million grant to primary investigator David Kimberlin, MD, a UAB professor of pediatrics. Carlos Pardo-Villamizar, MD, professor of neurology and pathology at Johns Hopkins University, Baltimore, is the co-principal investigator.
The university will organize and implement the international, multisite study. Its primary goal is to examine the incidence and distribution of AFM, and its pathogenesis and progression. Enrollment is expected to commence next fall. Investigators will enroll children with symptoms of AFM and follow them for 1 year. Household contacts of the subjects will serve as comparators.
In addition to collecting data about risk factors and disease progression, the researchers will collect clinical specimens, including blood and cerebrospinal fluid. More details about the design and study sites will be released then, according to a press statement issued by NIAID.
AFM targets spinal nerves and often develops after a mild respiratory illness. The disease mounted a global epidemic comeback in 2014, primarily affecting children; it has occurred concurrently with enterovirus outbreaks.
“Growing epidemiological evidence suggests that enterovirus-D68 [EV-D68] could play a role,” the statement noted. “Most people who become infected with EV-D68 are asymptomatic or experience mild, cold-like symptoms. Researchers and physicians are working to understand if there is a connection between these viral outbreaks and AFM, and if so, why some children but not others experience this sudden muscle weakness and paralysis.”
The study will draw on the expertise of the AFM Task Force, established last fall. The group comprises physicians, scientists, and public health experts from diverse disciplines and institutions who will assist in the ongoing investigation.
The AFM natural history study is funded under contract HHSN272201600018C.
Researchers at the University of Alabama at Birmingham will lead a 5-year, federally-funded study of acute flaccid myelitis (AFM) – a rare pediatric neurologic disease.
The National Institute of Allergy and Infectious Diseases (NIAID) awarded the $10 million grant to primary investigator David Kimberlin, MD, a UAB professor of pediatrics. Carlos Pardo-Villamizar, MD, professor of neurology and pathology at Johns Hopkins University, Baltimore, is the co-principal investigator.
The university will organize and implement the international, multisite study. Its primary goal is to examine the incidence and distribution of AFM, and its pathogenesis and progression. Enrollment is expected to commence next fall. Investigators will enroll children with symptoms of AFM and follow them for 1 year. Household contacts of the subjects will serve as comparators.
In addition to collecting data about risk factors and disease progression, the researchers will collect clinical specimens, including blood and cerebrospinal fluid. More details about the design and study sites will be released then, according to a press statement issued by NIAID.
AFM targets spinal nerves and often develops after a mild respiratory illness. The disease mounted a global epidemic comeback in 2014, primarily affecting children; it has occurred concurrently with enterovirus outbreaks.
“Growing epidemiological evidence suggests that enterovirus-D68 [EV-D68] could play a role,” the statement noted. “Most people who become infected with EV-D68 are asymptomatic or experience mild, cold-like symptoms. Researchers and physicians are working to understand if there is a connection between these viral outbreaks and AFM, and if so, why some children but not others experience this sudden muscle weakness and paralysis.”
The study will draw on the expertise of the AFM Task Force, established last fall. The group comprises physicians, scientists, and public health experts from diverse disciplines and institutions who will assist in the ongoing investigation.
The AFM natural history study is funded under contract HHSN272201600018C.
Summary: American Medical Society for Sports Medicine position statement on concussion in sport
An estimated 1-1.8 million sport-related concussions (SRC) occur per year in patients younger than 18 years of age. Concussion is defined as “a traumatically induced transient disturbance of brain function.” More than 50% of concussions among high school youth are not related to organized sports and between 2% and 15% of athletes in organized sports will sustain a concussion during a season of play.
which will be described in this article. The guidelines include recommendations for imaging, treatment, and decision making regarding when as well as whether to return to play. Here is a brief summary of those recommendations.
Preseason: Preseason evaluation includes a preparticipation physical evaluation and discussion of concussion history as well as risk factors associated with prolonged concussion recovery. Neurocognitive tests are available for baseline evaluation. While these may assist with diagnosis and return-to-play decisions, there can be considerable variation in an individual’s baseline score as well as the possibility of changes in that baseline over time. Because of this potential for variability, these tests are not required or accepted as the standard of care.
Sideline assessment: Familiarity with the athlete is the best way to detect subtle changes in personality or performance. Looking at symptoms is still the most sensitive way to diagnose a concussion. Loss of consciousness, seizure, tonic posturing, lack of motor coordination, confusion, amnesia, difficulty with balance, or any cognitive difficulty should prompt removal from play for possible concussion. Once a potential injury is identified, how the athlete responds to the elements of orientation, memory, concentration, speech pattern, and balance should be evaluated. If an athlete has a probable or definite concussion, the athlete needs to be removed from play and cannot return to same-day play, and a more detailed evaluation needs to be done.
Office assessment: It is not unusual for symptoms and testing to normalize by the time an office visit occurs. If this is the case, the visit should focus on recommendations for safe return to school and sport. A standard office evaluation should include taking a history with details of the mechanism of injury and preexisting conditions – such as depression and prior concussion – that can affect concussion recovery. The history should focus on detecting symptoms that typically cause impairment from concussion: headache, ocular-vestibular issues leading to problems with balance, and cognitive issues with difficulty concentrating and remembering, as well as fatigue and mood issues such as anxiety, irritability, and depression. The physical exam should include assessment of ocular and vestibular function, gait, and balance in addition to a neurological exam.
Imaging: Head CT or MRI are rarely indicated. Intracranial bleeds are rare in the context of SRC but can occur. If there is concern for a bleed, then CT scan is the imaging test of choice. MRI may have value for evaluation for atypical or prolonged recovery.
Recovery time: The large majority (80%-90%) of concussed older adolescents and adults return to preinjury levels of function within 2 weeks; in younger athletes, clinical recovery may take up to 4 weeks. The best predictor of recovery from SRC is the number and severity of symptoms.
Treatment: For decades, cognitive and physical rest has been the standard of treatment. However, this is no longer the “gold standard” as it has been shown that strict rest (“cocoon therapy”) after SRC slows recovery and leads to an increased chance of prolonged symptoms. Current consensus guidelines support 24-48 hours of symptom-limited rest, both cognitive and physical, followed by a gradual increase in activity, staying below symptom-exacerbation thresholds. Activity, along with good sleep hygiene, appears to be helpful in facilitating recovery from SRC. In athletes with persistent post concussive symptoms that continue beyond the expected recovery time frame, activities of daily living, school, and exercise that do not significantly exacerbate symptoms are recommended.
Return to learning/play: A concussion can cause temporary deficits in attention, cognitive processing, short-term memory, and executive functioning. School personnel should be informed of the injury and assist in employing an individualized return to learn plan, including academic accommodations. Ultimately, return to sports activities should follow a successful return to the classroom. Return to play involves a stepwise increase in physical demands/activity without symptoms before a student is allowed to participate in full contact play.
Concussion-related risks: Continuing to participate in sports before resolution of concussion can worsen and prolong symptoms of SRC. Returning too early after concussion, before full recovery, increases the risk of recurrent SRC. During the initial post-injury period, returning to sports too early increases the risk for a rare but devastating possibility of second impact syndrome that can be a life-threatening repeat head injury. Studies of long-term mental health diagnoses are conflicting and inconsistent. Chronic traumatic encephalopathy has been described in athletes with a long history of concussions and repetitive sub-symptom head impacts. The degree of exposure needed appears to be variable and dependent on the individual.
Disqualification from play: Because each athlete is individually assessed after SRC, there are no evidence-based studies indicating how many concussions are “safe” for an athlete to have in a lifetime. The decision to stop playing sports is both serious and difficult for most athletes and requires shared decision making between clinician, the athlete, and the athlete’s parents. Factors to consider when determining if disqualification from play is warranted include:
- The total number of concussions experienced by a patient.
- Whether a patient has sustained subsequent concussions with progressively less forceful blows to the head.
- If a patient has sustained multiple concussions,whether the time to complete a full recovery after each concussion event increased.
The bottom line: “Cocoon therapy” is no longer recommended. Consensus guidelines endorse 24-48 hours of symptom-limited cognitive and physical rest followed by a gradual increase in activity, including noncontact physical activity that does not provoke symptoms.
Dr. Belogorodsky is a second-year resident and Dr. Fidler is an associate director in the Family Medicine Residency Program at Abington (Pa.) Jefferson Health. Dr. Skolnik is professor of family and community medicine at Jefferson Medical College, Philadelphia, and an associate director of the family medicine residency program at Abington Jefferson Health.
Reference
Harmon KG et al. American Medical Society for Sports Medicine position statement on concussion in sport. Br J Sports Med. 2019;53:213-25.
An estimated 1-1.8 million sport-related concussions (SRC) occur per year in patients younger than 18 years of age. Concussion is defined as “a traumatically induced transient disturbance of brain function.” More than 50% of concussions among high school youth are not related to organized sports and between 2% and 15% of athletes in organized sports will sustain a concussion during a season of play.
which will be described in this article. The guidelines include recommendations for imaging, treatment, and decision making regarding when as well as whether to return to play. Here is a brief summary of those recommendations.
Preseason: Preseason evaluation includes a preparticipation physical evaluation and discussion of concussion history as well as risk factors associated with prolonged concussion recovery. Neurocognitive tests are available for baseline evaluation. While these may assist with diagnosis and return-to-play decisions, there can be considerable variation in an individual’s baseline score as well as the possibility of changes in that baseline over time. Because of this potential for variability, these tests are not required or accepted as the standard of care.
Sideline assessment: Familiarity with the athlete is the best way to detect subtle changes in personality or performance. Looking at symptoms is still the most sensitive way to diagnose a concussion. Loss of consciousness, seizure, tonic posturing, lack of motor coordination, confusion, amnesia, difficulty with balance, or any cognitive difficulty should prompt removal from play for possible concussion. Once a potential injury is identified, how the athlete responds to the elements of orientation, memory, concentration, speech pattern, and balance should be evaluated. If an athlete has a probable or definite concussion, the athlete needs to be removed from play and cannot return to same-day play, and a more detailed evaluation needs to be done.
Office assessment: It is not unusual for symptoms and testing to normalize by the time an office visit occurs. If this is the case, the visit should focus on recommendations for safe return to school and sport. A standard office evaluation should include taking a history with details of the mechanism of injury and preexisting conditions – such as depression and prior concussion – that can affect concussion recovery. The history should focus on detecting symptoms that typically cause impairment from concussion: headache, ocular-vestibular issues leading to problems with balance, and cognitive issues with difficulty concentrating and remembering, as well as fatigue and mood issues such as anxiety, irritability, and depression. The physical exam should include assessment of ocular and vestibular function, gait, and balance in addition to a neurological exam.
Imaging: Head CT or MRI are rarely indicated. Intracranial bleeds are rare in the context of SRC but can occur. If there is concern for a bleed, then CT scan is the imaging test of choice. MRI may have value for evaluation for atypical or prolonged recovery.
Recovery time: The large majority (80%-90%) of concussed older adolescents and adults return to preinjury levels of function within 2 weeks; in younger athletes, clinical recovery may take up to 4 weeks. The best predictor of recovery from SRC is the number and severity of symptoms.
Treatment: For decades, cognitive and physical rest has been the standard of treatment. However, this is no longer the “gold standard” as it has been shown that strict rest (“cocoon therapy”) after SRC slows recovery and leads to an increased chance of prolonged symptoms. Current consensus guidelines support 24-48 hours of symptom-limited rest, both cognitive and physical, followed by a gradual increase in activity, staying below symptom-exacerbation thresholds. Activity, along with good sleep hygiene, appears to be helpful in facilitating recovery from SRC. In athletes with persistent post concussive symptoms that continue beyond the expected recovery time frame, activities of daily living, school, and exercise that do not significantly exacerbate symptoms are recommended.
Return to learning/play: A concussion can cause temporary deficits in attention, cognitive processing, short-term memory, and executive functioning. School personnel should be informed of the injury and assist in employing an individualized return to learn plan, including academic accommodations. Ultimately, return to sports activities should follow a successful return to the classroom. Return to play involves a stepwise increase in physical demands/activity without symptoms before a student is allowed to participate in full contact play.
Concussion-related risks: Continuing to participate in sports before resolution of concussion can worsen and prolong symptoms of SRC. Returning too early after concussion, before full recovery, increases the risk of recurrent SRC. During the initial post-injury period, returning to sports too early increases the risk for a rare but devastating possibility of second impact syndrome that can be a life-threatening repeat head injury. Studies of long-term mental health diagnoses are conflicting and inconsistent. Chronic traumatic encephalopathy has been described in athletes with a long history of concussions and repetitive sub-symptom head impacts. The degree of exposure needed appears to be variable and dependent on the individual.
Disqualification from play: Because each athlete is individually assessed after SRC, there are no evidence-based studies indicating how many concussions are “safe” for an athlete to have in a lifetime. The decision to stop playing sports is both serious and difficult for most athletes and requires shared decision making between clinician, the athlete, and the athlete’s parents. Factors to consider when determining if disqualification from play is warranted include:
- The total number of concussions experienced by a patient.
- Whether a patient has sustained subsequent concussions with progressively less forceful blows to the head.
- If a patient has sustained multiple concussions,whether the time to complete a full recovery after each concussion event increased.
The bottom line: “Cocoon therapy” is no longer recommended. Consensus guidelines endorse 24-48 hours of symptom-limited cognitive and physical rest followed by a gradual increase in activity, including noncontact physical activity that does not provoke symptoms.
Dr. Belogorodsky is a second-year resident and Dr. Fidler is an associate director in the Family Medicine Residency Program at Abington (Pa.) Jefferson Health. Dr. Skolnik is professor of family and community medicine at Jefferson Medical College, Philadelphia, and an associate director of the family medicine residency program at Abington Jefferson Health.
Reference
Harmon KG et al. American Medical Society for Sports Medicine position statement on concussion in sport. Br J Sports Med. 2019;53:213-25.
An estimated 1-1.8 million sport-related concussions (SRC) occur per year in patients younger than 18 years of age. Concussion is defined as “a traumatically induced transient disturbance of brain function.” More than 50% of concussions among high school youth are not related to organized sports and between 2% and 15% of athletes in organized sports will sustain a concussion during a season of play.
which will be described in this article. The guidelines include recommendations for imaging, treatment, and decision making regarding when as well as whether to return to play. Here is a brief summary of those recommendations.
Preseason: Preseason evaluation includes a preparticipation physical evaluation and discussion of concussion history as well as risk factors associated with prolonged concussion recovery. Neurocognitive tests are available for baseline evaluation. While these may assist with diagnosis and return-to-play decisions, there can be considerable variation in an individual’s baseline score as well as the possibility of changes in that baseline over time. Because of this potential for variability, these tests are not required or accepted as the standard of care.
Sideline assessment: Familiarity with the athlete is the best way to detect subtle changes in personality or performance. Looking at symptoms is still the most sensitive way to diagnose a concussion. Loss of consciousness, seizure, tonic posturing, lack of motor coordination, confusion, amnesia, difficulty with balance, or any cognitive difficulty should prompt removal from play for possible concussion. Once a potential injury is identified, how the athlete responds to the elements of orientation, memory, concentration, speech pattern, and balance should be evaluated. If an athlete has a probable or definite concussion, the athlete needs to be removed from play and cannot return to same-day play, and a more detailed evaluation needs to be done.
Office assessment: It is not unusual for symptoms and testing to normalize by the time an office visit occurs. If this is the case, the visit should focus on recommendations for safe return to school and sport. A standard office evaluation should include taking a history with details of the mechanism of injury and preexisting conditions – such as depression and prior concussion – that can affect concussion recovery. The history should focus on detecting symptoms that typically cause impairment from concussion: headache, ocular-vestibular issues leading to problems with balance, and cognitive issues with difficulty concentrating and remembering, as well as fatigue and mood issues such as anxiety, irritability, and depression. The physical exam should include assessment of ocular and vestibular function, gait, and balance in addition to a neurological exam.
Imaging: Head CT or MRI are rarely indicated. Intracranial bleeds are rare in the context of SRC but can occur. If there is concern for a bleed, then CT scan is the imaging test of choice. MRI may have value for evaluation for atypical or prolonged recovery.
Recovery time: The large majority (80%-90%) of concussed older adolescents and adults return to preinjury levels of function within 2 weeks; in younger athletes, clinical recovery may take up to 4 weeks. The best predictor of recovery from SRC is the number and severity of symptoms.
Treatment: For decades, cognitive and physical rest has been the standard of treatment. However, this is no longer the “gold standard” as it has been shown that strict rest (“cocoon therapy”) after SRC slows recovery and leads to an increased chance of prolonged symptoms. Current consensus guidelines support 24-48 hours of symptom-limited rest, both cognitive and physical, followed by a gradual increase in activity, staying below symptom-exacerbation thresholds. Activity, along with good sleep hygiene, appears to be helpful in facilitating recovery from SRC. In athletes with persistent post concussive symptoms that continue beyond the expected recovery time frame, activities of daily living, school, and exercise that do not significantly exacerbate symptoms are recommended.
Return to learning/play: A concussion can cause temporary deficits in attention, cognitive processing, short-term memory, and executive functioning. School personnel should be informed of the injury and assist in employing an individualized return to learn plan, including academic accommodations. Ultimately, return to sports activities should follow a successful return to the classroom. Return to play involves a stepwise increase in physical demands/activity without symptoms before a student is allowed to participate in full contact play.
Concussion-related risks: Continuing to participate in sports before resolution of concussion can worsen and prolong symptoms of SRC. Returning too early after concussion, before full recovery, increases the risk of recurrent SRC. During the initial post-injury period, returning to sports too early increases the risk for a rare but devastating possibility of second impact syndrome that can be a life-threatening repeat head injury. Studies of long-term mental health diagnoses are conflicting and inconsistent. Chronic traumatic encephalopathy has been described in athletes with a long history of concussions and repetitive sub-symptom head impacts. The degree of exposure needed appears to be variable and dependent on the individual.
Disqualification from play: Because each athlete is individually assessed after SRC, there are no evidence-based studies indicating how many concussions are “safe” for an athlete to have in a lifetime. The decision to stop playing sports is both serious and difficult for most athletes and requires shared decision making between clinician, the athlete, and the athlete’s parents. Factors to consider when determining if disqualification from play is warranted include:
- The total number of concussions experienced by a patient.
- Whether a patient has sustained subsequent concussions with progressively less forceful blows to the head.
- If a patient has sustained multiple concussions,whether the time to complete a full recovery after each concussion event increased.
The bottom line: “Cocoon therapy” is no longer recommended. Consensus guidelines endorse 24-48 hours of symptom-limited cognitive and physical rest followed by a gradual increase in activity, including noncontact physical activity that does not provoke symptoms.
Dr. Belogorodsky is a second-year resident and Dr. Fidler is an associate director in the Family Medicine Residency Program at Abington (Pa.) Jefferson Health. Dr. Skolnik is professor of family and community medicine at Jefferson Medical College, Philadelphia, and an associate director of the family medicine residency program at Abington Jefferson Health.
Reference
Harmon KG et al. American Medical Society for Sports Medicine position statement on concussion in sport. Br J Sports Med. 2019;53:213-25.
PHiD-CV with 4CMenB safe, effective for infants
Concomitant administration of pneumococcal and meningococcal vaccines is not only safe but also offers the potential to improve vaccine uptake and reduce the number of doctors’ visits required for routine vaccination, advised Marco Aurelio P. Safadi, MD, PhD, of Santa Casa de São Paulo School of Medical Sciences, Brazil, and associates.
In a post hoc analysis of a phase 3b open-label study, Dr. Safadi and associates sought to evaluate immune response in pneumococcal non-typeable Haemophilus influenzae protein D conjugate vaccine (PHiD-CV) administered concomitantly with either meningococcal serogroup B (4CMenB) vaccine and CRM-conjugated meningococcal serogroup C vaccine (MenC-CRM) or with MenC-CRM alone using reduced schedules in 213 healthy infants aged 83-104 days. Study participants were enrolled and randomized to one of two groups between April 2011 and December 2014 at four sites in Brazil (Vaccine. 2019 Jul 18. doi: 10.1016/j.vaccine.2019.07.021).
Similar immune response was seen with vaccine serotypes and vaccine-related pneumococcal serotypes 6A and 19A in children who had received concomitant administration of PHiD-CV, 4CMenB, and MenC-CRM without 4CMenB.
Dr. Safadi and associates pointed out that PHiD-CV was given in accordance with a 3+1 dosing schedule, while 4CMenB used a reduced 2+1 schedule, which was observed to produce an immune response and provide an acceptable safety profile.
The findings yielded valuable information for the 2+1 PHiD-CV vaccination schedule, which was recently introduced in Brazil, the researchers said. The post-booster results further reflect the “immunogenicity following 3-dose priming.”
The post hoc nature of this study design effectively demonstrated that or with MenC-CRM alone, they explained.
The study was supported by GlaxoSmithKline (GSK) Biologicals. Three authors are employees of the GSK group of companies, and three others received a grant from the GSK companies, two of whom received compensation from other pharmaceutical companies. The institution of one of the authors received clinical trial fees from the GSK companies, and received personal fees/nonfinancial support/grants/other from the GSK companies and many other pharmaceutical companies.
Concomitant administration of pneumococcal and meningococcal vaccines is not only safe but also offers the potential to improve vaccine uptake and reduce the number of doctors’ visits required for routine vaccination, advised Marco Aurelio P. Safadi, MD, PhD, of Santa Casa de São Paulo School of Medical Sciences, Brazil, and associates.
In a post hoc analysis of a phase 3b open-label study, Dr. Safadi and associates sought to evaluate immune response in pneumococcal non-typeable Haemophilus influenzae protein D conjugate vaccine (PHiD-CV) administered concomitantly with either meningococcal serogroup B (4CMenB) vaccine and CRM-conjugated meningococcal serogroup C vaccine (MenC-CRM) or with MenC-CRM alone using reduced schedules in 213 healthy infants aged 83-104 days. Study participants were enrolled and randomized to one of two groups between April 2011 and December 2014 at four sites in Brazil (Vaccine. 2019 Jul 18. doi: 10.1016/j.vaccine.2019.07.021).
Similar immune response was seen with vaccine serotypes and vaccine-related pneumococcal serotypes 6A and 19A in children who had received concomitant administration of PHiD-CV, 4CMenB, and MenC-CRM without 4CMenB.
Dr. Safadi and associates pointed out that PHiD-CV was given in accordance with a 3+1 dosing schedule, while 4CMenB used a reduced 2+1 schedule, which was observed to produce an immune response and provide an acceptable safety profile.
The findings yielded valuable information for the 2+1 PHiD-CV vaccination schedule, which was recently introduced in Brazil, the researchers said. The post-booster results further reflect the “immunogenicity following 3-dose priming.”
The post hoc nature of this study design effectively demonstrated that or with MenC-CRM alone, they explained.
The study was supported by GlaxoSmithKline (GSK) Biologicals. Three authors are employees of the GSK group of companies, and three others received a grant from the GSK companies, two of whom received compensation from other pharmaceutical companies. The institution of one of the authors received clinical trial fees from the GSK companies, and received personal fees/nonfinancial support/grants/other from the GSK companies and many other pharmaceutical companies.
Concomitant administration of pneumococcal and meningococcal vaccines is not only safe but also offers the potential to improve vaccine uptake and reduce the number of doctors’ visits required for routine vaccination, advised Marco Aurelio P. Safadi, MD, PhD, of Santa Casa de São Paulo School of Medical Sciences, Brazil, and associates.
In a post hoc analysis of a phase 3b open-label study, Dr. Safadi and associates sought to evaluate immune response in pneumococcal non-typeable Haemophilus influenzae protein D conjugate vaccine (PHiD-CV) administered concomitantly with either meningococcal serogroup B (4CMenB) vaccine and CRM-conjugated meningococcal serogroup C vaccine (MenC-CRM) or with MenC-CRM alone using reduced schedules in 213 healthy infants aged 83-104 days. Study participants were enrolled and randomized to one of two groups between April 2011 and December 2014 at four sites in Brazil (Vaccine. 2019 Jul 18. doi: 10.1016/j.vaccine.2019.07.021).
Similar immune response was seen with vaccine serotypes and vaccine-related pneumococcal serotypes 6A and 19A in children who had received concomitant administration of PHiD-CV, 4CMenB, and MenC-CRM without 4CMenB.
Dr. Safadi and associates pointed out that PHiD-CV was given in accordance with a 3+1 dosing schedule, while 4CMenB used a reduced 2+1 schedule, which was observed to produce an immune response and provide an acceptable safety profile.
The findings yielded valuable information for the 2+1 PHiD-CV vaccination schedule, which was recently introduced in Brazil, the researchers said. The post-booster results further reflect the “immunogenicity following 3-dose priming.”
The post hoc nature of this study design effectively demonstrated that or with MenC-CRM alone, they explained.
The study was supported by GlaxoSmithKline (GSK) Biologicals. Three authors are employees of the GSK group of companies, and three others received a grant from the GSK companies, two of whom received compensation from other pharmaceutical companies. The institution of one of the authors received clinical trial fees from the GSK companies, and received personal fees/nonfinancial support/grants/other from the GSK companies and many other pharmaceutical companies.
FROM VACCINE
Hadlima approved as fourth adalimumab biosimilar in U.S.
The Food and Drug Administration has approved the Humira biosimilar Hadlima (adalimumab-bwwd), making it the fourth adalimumab biosimilar approved in the United States, the agency announced.
Hadlima is approved for seven of the reference product’s indications, which include rheumatoid arthritis, polyarticular juvenile idiopathic arthritis, plaque psoriasis, psoriatic arthritis, ankylosing spondylitis, adult Crohn’s disease, and ulcerative colitis.
The product will launch in the United States on June 30, 2023. Other FDA-approved adalimumab biosimilars – Amjevita (adalimunab-atto), Cyltezo (adalimumab-adbm), Hyrimoz (adalimumab-adaz) – similarly will not reach the U.S. market until 2023.
Hadlima is developed by Samsung Bioepis and commercialized by Merck Sharp & Dohme Corp., a subsidiary of Merck & Co.
*This article was updated on July 24, 2019.
The Food and Drug Administration has approved the Humira biosimilar Hadlima (adalimumab-bwwd), making it the fourth adalimumab biosimilar approved in the United States, the agency announced.
Hadlima is approved for seven of the reference product’s indications, which include rheumatoid arthritis, polyarticular juvenile idiopathic arthritis, plaque psoriasis, psoriatic arthritis, ankylosing spondylitis, adult Crohn’s disease, and ulcerative colitis.
The product will launch in the United States on June 30, 2023. Other FDA-approved adalimumab biosimilars – Amjevita (adalimunab-atto), Cyltezo (adalimumab-adbm), Hyrimoz (adalimumab-adaz) – similarly will not reach the U.S. market until 2023.
Hadlima is developed by Samsung Bioepis and commercialized by Merck Sharp & Dohme Corp., a subsidiary of Merck & Co.
*This article was updated on July 24, 2019.
The Food and Drug Administration has approved the Humira biosimilar Hadlima (adalimumab-bwwd), making it the fourth adalimumab biosimilar approved in the United States, the agency announced.
Hadlima is approved for seven of the reference product’s indications, which include rheumatoid arthritis, polyarticular juvenile idiopathic arthritis, plaque psoriasis, psoriatic arthritis, ankylosing spondylitis, adult Crohn’s disease, and ulcerative colitis.
The product will launch in the United States on June 30, 2023. Other FDA-approved adalimumab biosimilars – Amjevita (adalimunab-atto), Cyltezo (adalimumab-adbm), Hyrimoz (adalimumab-adaz) – similarly will not reach the U.S. market until 2023.
Hadlima is developed by Samsung Bioepis and commercialized by Merck Sharp & Dohme Corp., a subsidiary of Merck & Co.
*This article was updated on July 24, 2019.