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Educate your adolescent patients about herpes
We are all familiar with the line, “Herpes lasts forever.” There is no cure for infection with a herpes virus, whether it is herpes simplex 1 (HSV-1) or herpes simplex 2 (HSV-2).
There are antivirals to reduce the length and severity of flare-ups, and continued therapy can suppress the virus, which reduces shedding. Both HSV-1 and HSV-2 can cause genital herpes and oral herpes, i.e. cold sores. HSV-1 has a milder initial episode and fewer flareups, whereas HSV-2 can have a more severe initial episode and frequent flareups.1
According to data from the National Health and Nutrition Examination Survey (NHANES) for 2015-2016, HSV-1 prevalence was 48% among 14- to 19-year-olds and HSV-2 prevalence was 12% in the same age group. Overall, age-adjusted HSV-1 prevalence was higher in females (51%) than in males (45%) in persons aged 14-49 years.2
The reality is that most people with HSV-1 or HSV-2 don’t even know they have it, as both tend to be asymptomatic. Therefore, all reported statistics are grossly underrepresenting the prevalence of the disease.
HSV is a common disease. Regardless of symptoms, shedding occurs. Although condoms reduce the risk of spread, using one doesn’t eliminate it because of the possibility of contact beyond the area covered by the condom and the ability of HSV to be passed through oral sex. The only true prevention is abstinence.
Herpes simplex virus is a sexually transmitted infection that is lifelong. Its presence can increase the risk of contracting HIV. If it is contracted in the third trimester of pregnancy or if a breakout occurs during the third trimester, risk of transmitting to the infant can occur, with devastating neurological impact. Despite the seriousness and longevity of the virus, the vast majority of people with the virus have it unknowingly, and live normal healthy lives.
It is just as important that we educate them that, if they contract herpes, it is not end of their ability to have intimate relationships. Debunking the myth that HSV-2 is a worse disease to have than HSV-1 can significantly reduce the psychological burden caused by this disease, and encourage patients to be more honest about their diagnosis. This not only will assist people in seeking medical advice if they have concerns, but it will encourage conversations about HSV, which hopefully will reduce spread of the virus.
Dr. Pearce is a pediatrician in Frankfort, Ill. She said she had no relevant financial disclosures. Email her at [email protected].
References
1. J Infect Dis. 2014 Feb. doi: 10.1093/infdis/jit458.
2. NCHS Data Brief, no 304. 2018 Feb.
We are all familiar with the line, “Herpes lasts forever.” There is no cure for infection with a herpes virus, whether it is herpes simplex 1 (HSV-1) or herpes simplex 2 (HSV-2).
There are antivirals to reduce the length and severity of flare-ups, and continued therapy can suppress the virus, which reduces shedding. Both HSV-1 and HSV-2 can cause genital herpes and oral herpes, i.e. cold sores. HSV-1 has a milder initial episode and fewer flareups, whereas HSV-2 can have a more severe initial episode and frequent flareups.1
According to data from the National Health and Nutrition Examination Survey (NHANES) for 2015-2016, HSV-1 prevalence was 48% among 14- to 19-year-olds and HSV-2 prevalence was 12% in the same age group. Overall, age-adjusted HSV-1 prevalence was higher in females (51%) than in males (45%) in persons aged 14-49 years.2
The reality is that most people with HSV-1 or HSV-2 don’t even know they have it, as both tend to be asymptomatic. Therefore, all reported statistics are grossly underrepresenting the prevalence of the disease.
HSV is a common disease. Regardless of symptoms, shedding occurs. Although condoms reduce the risk of spread, using one doesn’t eliminate it because of the possibility of contact beyond the area covered by the condom and the ability of HSV to be passed through oral sex. The only true prevention is abstinence.
Herpes simplex virus is a sexually transmitted infection that is lifelong. Its presence can increase the risk of contracting HIV. If it is contracted in the third trimester of pregnancy or if a breakout occurs during the third trimester, risk of transmitting to the infant can occur, with devastating neurological impact. Despite the seriousness and longevity of the virus, the vast majority of people with the virus have it unknowingly, and live normal healthy lives.
It is just as important that we educate them that, if they contract herpes, it is not end of their ability to have intimate relationships. Debunking the myth that HSV-2 is a worse disease to have than HSV-1 can significantly reduce the psychological burden caused by this disease, and encourage patients to be more honest about their diagnosis. This not only will assist people in seeking medical advice if they have concerns, but it will encourage conversations about HSV, which hopefully will reduce spread of the virus.
Dr. Pearce is a pediatrician in Frankfort, Ill. She said she had no relevant financial disclosures. Email her at [email protected].
References
1. J Infect Dis. 2014 Feb. doi: 10.1093/infdis/jit458.
2. NCHS Data Brief, no 304. 2018 Feb.
We are all familiar with the line, “Herpes lasts forever.” There is no cure for infection with a herpes virus, whether it is herpes simplex 1 (HSV-1) or herpes simplex 2 (HSV-2).
There are antivirals to reduce the length and severity of flare-ups, and continued therapy can suppress the virus, which reduces shedding. Both HSV-1 and HSV-2 can cause genital herpes and oral herpes, i.e. cold sores. HSV-1 has a milder initial episode and fewer flareups, whereas HSV-2 can have a more severe initial episode and frequent flareups.1
According to data from the National Health and Nutrition Examination Survey (NHANES) for 2015-2016, HSV-1 prevalence was 48% among 14- to 19-year-olds and HSV-2 prevalence was 12% in the same age group. Overall, age-adjusted HSV-1 prevalence was higher in females (51%) than in males (45%) in persons aged 14-49 years.2
The reality is that most people with HSV-1 or HSV-2 don’t even know they have it, as both tend to be asymptomatic. Therefore, all reported statistics are grossly underrepresenting the prevalence of the disease.
HSV is a common disease. Regardless of symptoms, shedding occurs. Although condoms reduce the risk of spread, using one doesn’t eliminate it because of the possibility of contact beyond the area covered by the condom and the ability of HSV to be passed through oral sex. The only true prevention is abstinence.
Herpes simplex virus is a sexually transmitted infection that is lifelong. Its presence can increase the risk of contracting HIV. If it is contracted in the third trimester of pregnancy or if a breakout occurs during the third trimester, risk of transmitting to the infant can occur, with devastating neurological impact. Despite the seriousness and longevity of the virus, the vast majority of people with the virus have it unknowingly, and live normal healthy lives.
It is just as important that we educate them that, if they contract herpes, it is not end of their ability to have intimate relationships. Debunking the myth that HSV-2 is a worse disease to have than HSV-1 can significantly reduce the psychological burden caused by this disease, and encourage patients to be more honest about their diagnosis. This not only will assist people in seeking medical advice if they have concerns, but it will encourage conversations about HSV, which hopefully will reduce spread of the virus.
Dr. Pearce is a pediatrician in Frankfort, Ill. She said she had no relevant financial disclosures. Email her at [email protected].
References
1. J Infect Dis. 2014 Feb. doi: 10.1093/infdis/jit458.
2. NCHS Data Brief, no 304. 2018 Feb.
Nonablative laser adds benefits to low-dose isotretinoin as treatment for moderate to severe acne
A combination of low-dose isotretinoin and nonablative fractional laser (NAFL) was a safe and effective treatment for moderate to severe acne and also improved acne scars in a small Chinese study, investigators reported.
In the randomized, split-face, controlled study of 18 adult Asian patients with moderate to severe acne, low-dose isotretinoin alone effectively controlled papule and pustule acne lesions, whereas NAFL had the additional effect of reducing the number of comedones and improving boxcar atrophic scars, reported Weihui Zeng, MD, and associates from the department of dermatology at the Second Affiliated Hospital of Xi’an Jiaotong University, Shanxi, China.
The authors noted that many patients seen at their clinic cannot tolerate a 20 mg/day dose of isotretinoin because of severe mucocutaneous side effects and that treatment with nonablative lasers, which – in contrast to ablative lasers – use infrared radiation to penetrate the skin deeply and thereby selectively heat dermal tissue while sparing the epidermis, could be a treatment option for these patients.
Therefore, they set out to investigate a treatment plan combining 1,550-nm NAFL with low-dose isotretinoin (10 mg/day) in the 18 patients (mean age, 24 years; skin types II-IV) attending their outpatient dermatology clinic. Three laser treatments were administered at monthly intervals to one side of the face, with the other side of the face serving as a control. Each patient was on low-dose isotretinoin for 30-45 days before laser treatment. A revised Leeds acne-grading system was used.
At follow-up after the third treatment – 3 months after the first laser treatment – both sides of the face showed significant recovery in all participants, but there was greater improvement on the laser-treated side. The mean Leeds acne-grading scores decreased from 10.6 at baseline to 5.8 on the control side of the face, and from 10.4 at baseline to 3.5 on the laser-treated side. The changes in scores differed significantly between sides (P less than .05), and the number of comedones decreased more on the laser-treated side of the face than it did the control side.
Significant improvements were also seen with superficial scars (P less than .05) and deep boxcar atrophic scars (P less than .01) on the laser-treated sides of patients’ faces, compared with the control sides, but significant improvements were not seen with the number of papules and nodules or with icepick or rolling scars.
Patients reported discomfort after NAFL treatment, including pain (100%), sensation of heat (100%), erythema (94.5%), and edema (88.9%), which resolved spontaneously within 24 hours.
Most of the patients (n = 12; 66.7%) were satisfied after the last treatment, two (11.1%) were “very satisfied,” and four (22.2%) were neutral; none were dissatisfied.
“Low-dose isotretinoin effectively controlled papule and pustule acne lesions, whereas use of 1,550-nm Er:glass NAFL may significantly reduce the number of comedones and improve boxcar atrophic scars,” the authors wrote.
They authors reported no significant interest with commercial supporters.
SOURCE: Xia J et al. Dermatol Surg. 2018 Sep;44(9):1201-8.
A combination of low-dose isotretinoin and nonablative fractional laser (NAFL) was a safe and effective treatment for moderate to severe acne and also improved acne scars in a small Chinese study, investigators reported.
In the randomized, split-face, controlled study of 18 adult Asian patients with moderate to severe acne, low-dose isotretinoin alone effectively controlled papule and pustule acne lesions, whereas NAFL had the additional effect of reducing the number of comedones and improving boxcar atrophic scars, reported Weihui Zeng, MD, and associates from the department of dermatology at the Second Affiliated Hospital of Xi’an Jiaotong University, Shanxi, China.
The authors noted that many patients seen at their clinic cannot tolerate a 20 mg/day dose of isotretinoin because of severe mucocutaneous side effects and that treatment with nonablative lasers, which – in contrast to ablative lasers – use infrared radiation to penetrate the skin deeply and thereby selectively heat dermal tissue while sparing the epidermis, could be a treatment option for these patients.
Therefore, they set out to investigate a treatment plan combining 1,550-nm NAFL with low-dose isotretinoin (10 mg/day) in the 18 patients (mean age, 24 years; skin types II-IV) attending their outpatient dermatology clinic. Three laser treatments were administered at monthly intervals to one side of the face, with the other side of the face serving as a control. Each patient was on low-dose isotretinoin for 30-45 days before laser treatment. A revised Leeds acne-grading system was used.
At follow-up after the third treatment – 3 months after the first laser treatment – both sides of the face showed significant recovery in all participants, but there was greater improvement on the laser-treated side. The mean Leeds acne-grading scores decreased from 10.6 at baseline to 5.8 on the control side of the face, and from 10.4 at baseline to 3.5 on the laser-treated side. The changes in scores differed significantly between sides (P less than .05), and the number of comedones decreased more on the laser-treated side of the face than it did the control side.
Significant improvements were also seen with superficial scars (P less than .05) and deep boxcar atrophic scars (P less than .01) on the laser-treated sides of patients’ faces, compared with the control sides, but significant improvements were not seen with the number of papules and nodules or with icepick or rolling scars.
Patients reported discomfort after NAFL treatment, including pain (100%), sensation of heat (100%), erythema (94.5%), and edema (88.9%), which resolved spontaneously within 24 hours.
Most of the patients (n = 12; 66.7%) were satisfied after the last treatment, two (11.1%) were “very satisfied,” and four (22.2%) were neutral; none were dissatisfied.
“Low-dose isotretinoin effectively controlled papule and pustule acne lesions, whereas use of 1,550-nm Er:glass NAFL may significantly reduce the number of comedones and improve boxcar atrophic scars,” the authors wrote.
They authors reported no significant interest with commercial supporters.
SOURCE: Xia J et al. Dermatol Surg. 2018 Sep;44(9):1201-8.
A combination of low-dose isotretinoin and nonablative fractional laser (NAFL) was a safe and effective treatment for moderate to severe acne and also improved acne scars in a small Chinese study, investigators reported.
In the randomized, split-face, controlled study of 18 adult Asian patients with moderate to severe acne, low-dose isotretinoin alone effectively controlled papule and pustule acne lesions, whereas NAFL had the additional effect of reducing the number of comedones and improving boxcar atrophic scars, reported Weihui Zeng, MD, and associates from the department of dermatology at the Second Affiliated Hospital of Xi’an Jiaotong University, Shanxi, China.
The authors noted that many patients seen at their clinic cannot tolerate a 20 mg/day dose of isotretinoin because of severe mucocutaneous side effects and that treatment with nonablative lasers, which – in contrast to ablative lasers – use infrared radiation to penetrate the skin deeply and thereby selectively heat dermal tissue while sparing the epidermis, could be a treatment option for these patients.
Therefore, they set out to investigate a treatment plan combining 1,550-nm NAFL with low-dose isotretinoin (10 mg/day) in the 18 patients (mean age, 24 years; skin types II-IV) attending their outpatient dermatology clinic. Three laser treatments were administered at monthly intervals to one side of the face, with the other side of the face serving as a control. Each patient was on low-dose isotretinoin for 30-45 days before laser treatment. A revised Leeds acne-grading system was used.
At follow-up after the third treatment – 3 months after the first laser treatment – both sides of the face showed significant recovery in all participants, but there was greater improvement on the laser-treated side. The mean Leeds acne-grading scores decreased from 10.6 at baseline to 5.8 on the control side of the face, and from 10.4 at baseline to 3.5 on the laser-treated side. The changes in scores differed significantly between sides (P less than .05), and the number of comedones decreased more on the laser-treated side of the face than it did the control side.
Significant improvements were also seen with superficial scars (P less than .05) and deep boxcar atrophic scars (P less than .01) on the laser-treated sides of patients’ faces, compared with the control sides, but significant improvements were not seen with the number of papules and nodules or with icepick or rolling scars.
Patients reported discomfort after NAFL treatment, including pain (100%), sensation of heat (100%), erythema (94.5%), and edema (88.9%), which resolved spontaneously within 24 hours.
Most of the patients (n = 12; 66.7%) were satisfied after the last treatment, two (11.1%) were “very satisfied,” and four (22.2%) were neutral; none were dissatisfied.
“Low-dose isotretinoin effectively controlled papule and pustule acne lesions, whereas use of 1,550-nm Er:glass NAFL may significantly reduce the number of comedones and improve boxcar atrophic scars,” the authors wrote.
They authors reported no significant interest with commercial supporters.
SOURCE: Xia J et al. Dermatol Surg. 2018 Sep;44(9):1201-8.
FROM DERMATOLOGIC SURGERY
Key clinical point: Adding nonablative fractional laser (NAFL) treatment to low-dose isotretinoin may reduce comedones and improve boxcar atrophic scarring in people with moderate to severe acne .
Major finding: Low-dose isotretinoin effectively controlled papule and pustule acne lesions, whereas nonablative laser also reduced the number of comedones and improved boxcar atrophic scars.
Study details: A prospective randomized, controlled, split-face study of 18 Asian adult patients with moderate to severe acne vulgaris, treated with low-dose isotretinoin, as well as NAFL to one side of the face.
Disclosures: The authors reported no significant interests with commercial supporters.
Source: Xia J et al. Dermatol Surg. 2018 Sep;44(9):1201-8.
All children deserve support for their gender identities
The Atlantic published the article “When Children Say They’re Trans” by Jesse Singal in its July/August edition not too long ago. In this article, the author wrote about the increasing availability of treatments for affirming one’s gender identity and the rising concerns about the risks surrounding those treatments.
A key issue in the article is the concept of desistance. Desistance is a phenomenon in which individuals no longer feel that their gender identities are incongruent with their physical appearance. Highly related to desistance is detransitioning, a phenomenon in which transgender individuals no longer take the steps (e.g., hormone therapy) to affirm their gender identity. Singal highlights the concern surrounding starting medical treatments to affirm an individual’s gender identity, considering that the changes are irreversible and that it is possible for children to change their minds. Implied in the article is a call for a cautious approach for treating children who identify as transgender because it will be difficult to predict what one’s final gender identity is; however, I believe that a better approach is to support the child in the journey in affirming the gender identity.
The evidence on the rate of desistance may not be accurate
One argument for the cautious approach is the often cited statistic that 80% of children with gender nonconforming behaviors do not identify as transgender when they are adults. This is derived from four published studies that track the gender identity of individuals with gender nonconforming behaviors in childhood.1-4 These estimates may not be accurate, mainly due to these studies’ methodological shortcomings. For example, those who were lost to follow-up were assumed to be cisgender as adults and no efforts were made to verify these individuals’ gender identity.2-4 I do not intend to thoroughly critique these studies in this column. This is best left to peer-reviewed commentaries (a good example is one written by Newhook et al. 2018).5 I worry, however, that some clinicians may dismiss a child’s gender identity based on these studies and recommend to the parents to delay supporting a transition until the child “knows for sure.” The problem with this approach is that it may worsen the health and well-being of transgender youth, as there is growing evidence that transgender children who are supported by their parents are less likely to have mental health problems.6,7
The reasons for desistance are far more complicated
The common narrative of desistance is that the individuals simply change their minds because they were “confused” during adolescence. However, the truth is more complicated. Children can identify their own gender as early as 2 years old;8 however, when a child’s gender identity matches the assigned sex at birth, this is often reinforced. In contrast, if a child’s gender identity does not match the assigned sex at birth, it often is challenged by peers and adults. This challenge by peers, their families, and medical providers may be one of the reasons why transitioning is so difficult for many transgender youth – and many do give up.3,9 In these cases, some people wait for years, if not decades, to come out again and start transitioning when they finally feel supported and safe – even in their 90s! Other transgender people realize that their gender identity is not on the binary (neither male nor female), so they no longer need cross-sex hormones or surgeries to affirm their gender identity. Finally, others are concerned about the side effects, such as infertility, and feel that the risks for those side effects are not worth it, so they find other, nonmedical or nonsurgical ways to affirm their gender identity or manage their gender dysphoria.
Positive outcomes are more common
Reports of youth detransitioning highlight many physicians’ fears of making a mistake; however, these reports obscure the more common – and positive – outcomes for transgender individuals who took steps to affirm their gender identity. The Report of the 2011 Transition Survey shows that 97% were satisfied with being on hormone therapy and 90% were satisfied with obtaining bottom surgery.10 Furthermore, there is growing evidence showing that such treatments are associated with better health.11 A study by de Vries et al. found that transgender youth who transitioned in adolescence had less depression and better adjustment as adults.12 Finally, there is a lack of evidence supporting the concept that someone whose gender identity is fluid over time is any less healthy than those whose gender identity is static over time. Rare outcomes should never be dismissed; however, providers should not use rare events as the primary driver for discouraging evidence-based treatment.
The key is support
I believe that every child’s gender identity should be supported and affirmed. Clinicians can provide this support and affirmation through the following actions:
- At the first visit, clinicians should ask what the child’s hopes and expectations are for pursuing gender-affirming medical treatments.
- Clinicians should allow the child the opportunity to describe and process their gender identity instead of assuming that they are on the binary.
- Clinicians must recognize the varied reasons for desistance – stigma, discrimination, shame, or need to fit within a gender binary – and find ways to address those factors.
- Clinicians should have a thorough discussion with patients and their families about the risks of not supporting the child’s gender identity versus the risk of medical or surgical treatments used to affirm one’s gender identity and process with the child and the family where the values and wishes are within the context of those risks.
- Most importantly, clinicians should emphasize support for whatever decisions the child makes to affirm their gender identity. Providing support is essential in promoting the health and well-being of any child.
Dr. Montano is assistant professor of pediatrics at the University of Pittsburgh and an adolescent medicine physician at Children’s Hospital of Pittsburgh of UPMC. Email him at [email protected].
References
1. Dev Psychol. 2008;44(1):34-45.
2. J Am Acad Child Adolesc Psychiatry. 2013 Jun;52(6):582-90.
3. Clin Child Psychol Psychiatry. 2011 Oct;16(4):499-516.
4. J Am Acad Child Adolesc Psychiatry. 2008 Dec;47(12):1413-23.
5. International Journal of Transgenderism. 2018;19(2):212-24.
6. Pediatrics. 2016 Mar;137(3):e20153223.
7. J Sex Marital Ther. 2010;36(1):6-23.
8. “Adolescence,” 11th ed. (New York: McGraw-Hill Education; 2016).
9. Graduate Journal of Social Science. 2010;7(2):26-43.
10. “Affirming Gender, Affirming Lives: A Report of the 2011 Transition Survey,” Gender Advocacy Training & Education, 2012.
11. Transgend Health. 2016 Jan;1(1):21-31.
12. Pediatrics. 2014 Oct;134(4):696-704.
The Atlantic published the article “When Children Say They’re Trans” by Jesse Singal in its July/August edition not too long ago. In this article, the author wrote about the increasing availability of treatments for affirming one’s gender identity and the rising concerns about the risks surrounding those treatments.
A key issue in the article is the concept of desistance. Desistance is a phenomenon in which individuals no longer feel that their gender identities are incongruent with their physical appearance. Highly related to desistance is detransitioning, a phenomenon in which transgender individuals no longer take the steps (e.g., hormone therapy) to affirm their gender identity. Singal highlights the concern surrounding starting medical treatments to affirm an individual’s gender identity, considering that the changes are irreversible and that it is possible for children to change their minds. Implied in the article is a call for a cautious approach for treating children who identify as transgender because it will be difficult to predict what one’s final gender identity is; however, I believe that a better approach is to support the child in the journey in affirming the gender identity.
The evidence on the rate of desistance may not be accurate
One argument for the cautious approach is the often cited statistic that 80% of children with gender nonconforming behaviors do not identify as transgender when they are adults. This is derived from four published studies that track the gender identity of individuals with gender nonconforming behaviors in childhood.1-4 These estimates may not be accurate, mainly due to these studies’ methodological shortcomings. For example, those who were lost to follow-up were assumed to be cisgender as adults and no efforts were made to verify these individuals’ gender identity.2-4 I do not intend to thoroughly critique these studies in this column. This is best left to peer-reviewed commentaries (a good example is one written by Newhook et al. 2018).5 I worry, however, that some clinicians may dismiss a child’s gender identity based on these studies and recommend to the parents to delay supporting a transition until the child “knows for sure.” The problem with this approach is that it may worsen the health and well-being of transgender youth, as there is growing evidence that transgender children who are supported by their parents are less likely to have mental health problems.6,7
The reasons for desistance are far more complicated
The common narrative of desistance is that the individuals simply change their minds because they were “confused” during adolescence. However, the truth is more complicated. Children can identify their own gender as early as 2 years old;8 however, when a child’s gender identity matches the assigned sex at birth, this is often reinforced. In contrast, if a child’s gender identity does not match the assigned sex at birth, it often is challenged by peers and adults. This challenge by peers, their families, and medical providers may be one of the reasons why transitioning is so difficult for many transgender youth – and many do give up.3,9 In these cases, some people wait for years, if not decades, to come out again and start transitioning when they finally feel supported and safe – even in their 90s! Other transgender people realize that their gender identity is not on the binary (neither male nor female), so they no longer need cross-sex hormones or surgeries to affirm their gender identity. Finally, others are concerned about the side effects, such as infertility, and feel that the risks for those side effects are not worth it, so they find other, nonmedical or nonsurgical ways to affirm their gender identity or manage their gender dysphoria.
Positive outcomes are more common
Reports of youth detransitioning highlight many physicians’ fears of making a mistake; however, these reports obscure the more common – and positive – outcomes for transgender individuals who took steps to affirm their gender identity. The Report of the 2011 Transition Survey shows that 97% were satisfied with being on hormone therapy and 90% were satisfied with obtaining bottom surgery.10 Furthermore, there is growing evidence showing that such treatments are associated with better health.11 A study by de Vries et al. found that transgender youth who transitioned in adolescence had less depression and better adjustment as adults.12 Finally, there is a lack of evidence supporting the concept that someone whose gender identity is fluid over time is any less healthy than those whose gender identity is static over time. Rare outcomes should never be dismissed; however, providers should not use rare events as the primary driver for discouraging evidence-based treatment.
The key is support
I believe that every child’s gender identity should be supported and affirmed. Clinicians can provide this support and affirmation through the following actions:
- At the first visit, clinicians should ask what the child’s hopes and expectations are for pursuing gender-affirming medical treatments.
- Clinicians should allow the child the opportunity to describe and process their gender identity instead of assuming that they are on the binary.
- Clinicians must recognize the varied reasons for desistance – stigma, discrimination, shame, or need to fit within a gender binary – and find ways to address those factors.
- Clinicians should have a thorough discussion with patients and their families about the risks of not supporting the child’s gender identity versus the risk of medical or surgical treatments used to affirm one’s gender identity and process with the child and the family where the values and wishes are within the context of those risks.
- Most importantly, clinicians should emphasize support for whatever decisions the child makes to affirm their gender identity. Providing support is essential in promoting the health and well-being of any child.
Dr. Montano is assistant professor of pediatrics at the University of Pittsburgh and an adolescent medicine physician at Children’s Hospital of Pittsburgh of UPMC. Email him at [email protected].
References
1. Dev Psychol. 2008;44(1):34-45.
2. J Am Acad Child Adolesc Psychiatry. 2013 Jun;52(6):582-90.
3. Clin Child Psychol Psychiatry. 2011 Oct;16(4):499-516.
4. J Am Acad Child Adolesc Psychiatry. 2008 Dec;47(12):1413-23.
5. International Journal of Transgenderism. 2018;19(2):212-24.
6. Pediatrics. 2016 Mar;137(3):e20153223.
7. J Sex Marital Ther. 2010;36(1):6-23.
8. “Adolescence,” 11th ed. (New York: McGraw-Hill Education; 2016).
9. Graduate Journal of Social Science. 2010;7(2):26-43.
10. “Affirming Gender, Affirming Lives: A Report of the 2011 Transition Survey,” Gender Advocacy Training & Education, 2012.
11. Transgend Health. 2016 Jan;1(1):21-31.
12. Pediatrics. 2014 Oct;134(4):696-704.
The Atlantic published the article “When Children Say They’re Trans” by Jesse Singal in its July/August edition not too long ago. In this article, the author wrote about the increasing availability of treatments for affirming one’s gender identity and the rising concerns about the risks surrounding those treatments.
A key issue in the article is the concept of desistance. Desistance is a phenomenon in which individuals no longer feel that their gender identities are incongruent with their physical appearance. Highly related to desistance is detransitioning, a phenomenon in which transgender individuals no longer take the steps (e.g., hormone therapy) to affirm their gender identity. Singal highlights the concern surrounding starting medical treatments to affirm an individual’s gender identity, considering that the changes are irreversible and that it is possible for children to change their minds. Implied in the article is a call for a cautious approach for treating children who identify as transgender because it will be difficult to predict what one’s final gender identity is; however, I believe that a better approach is to support the child in the journey in affirming the gender identity.
The evidence on the rate of desistance may not be accurate
One argument for the cautious approach is the often cited statistic that 80% of children with gender nonconforming behaviors do not identify as transgender when they are adults. This is derived from four published studies that track the gender identity of individuals with gender nonconforming behaviors in childhood.1-4 These estimates may not be accurate, mainly due to these studies’ methodological shortcomings. For example, those who were lost to follow-up were assumed to be cisgender as adults and no efforts were made to verify these individuals’ gender identity.2-4 I do not intend to thoroughly critique these studies in this column. This is best left to peer-reviewed commentaries (a good example is one written by Newhook et al. 2018).5 I worry, however, that some clinicians may dismiss a child’s gender identity based on these studies and recommend to the parents to delay supporting a transition until the child “knows for sure.” The problem with this approach is that it may worsen the health and well-being of transgender youth, as there is growing evidence that transgender children who are supported by their parents are less likely to have mental health problems.6,7
The reasons for desistance are far more complicated
The common narrative of desistance is that the individuals simply change their minds because they were “confused” during adolescence. However, the truth is more complicated. Children can identify their own gender as early as 2 years old;8 however, when a child’s gender identity matches the assigned sex at birth, this is often reinforced. In contrast, if a child’s gender identity does not match the assigned sex at birth, it often is challenged by peers and adults. This challenge by peers, their families, and medical providers may be one of the reasons why transitioning is so difficult for many transgender youth – and many do give up.3,9 In these cases, some people wait for years, if not decades, to come out again and start transitioning when they finally feel supported and safe – even in their 90s! Other transgender people realize that their gender identity is not on the binary (neither male nor female), so they no longer need cross-sex hormones or surgeries to affirm their gender identity. Finally, others are concerned about the side effects, such as infertility, and feel that the risks for those side effects are not worth it, so they find other, nonmedical or nonsurgical ways to affirm their gender identity or manage their gender dysphoria.
Positive outcomes are more common
Reports of youth detransitioning highlight many physicians’ fears of making a mistake; however, these reports obscure the more common – and positive – outcomes for transgender individuals who took steps to affirm their gender identity. The Report of the 2011 Transition Survey shows that 97% were satisfied with being on hormone therapy and 90% were satisfied with obtaining bottom surgery.10 Furthermore, there is growing evidence showing that such treatments are associated with better health.11 A study by de Vries et al. found that transgender youth who transitioned in adolescence had less depression and better adjustment as adults.12 Finally, there is a lack of evidence supporting the concept that someone whose gender identity is fluid over time is any less healthy than those whose gender identity is static over time. Rare outcomes should never be dismissed; however, providers should not use rare events as the primary driver for discouraging evidence-based treatment.
The key is support
I believe that every child’s gender identity should be supported and affirmed. Clinicians can provide this support and affirmation through the following actions:
- At the first visit, clinicians should ask what the child’s hopes and expectations are for pursuing gender-affirming medical treatments.
- Clinicians should allow the child the opportunity to describe and process their gender identity instead of assuming that they are on the binary.
- Clinicians must recognize the varied reasons for desistance – stigma, discrimination, shame, or need to fit within a gender binary – and find ways to address those factors.
- Clinicians should have a thorough discussion with patients and their families about the risks of not supporting the child’s gender identity versus the risk of medical or surgical treatments used to affirm one’s gender identity and process with the child and the family where the values and wishes are within the context of those risks.
- Most importantly, clinicians should emphasize support for whatever decisions the child makes to affirm their gender identity. Providing support is essential in promoting the health and well-being of any child.
Dr. Montano is assistant professor of pediatrics at the University of Pittsburgh and an adolescent medicine physician at Children’s Hospital of Pittsburgh of UPMC. Email him at [email protected].
References
1. Dev Psychol. 2008;44(1):34-45.
2. J Am Acad Child Adolesc Psychiatry. 2013 Jun;52(6):582-90.
3. Clin Child Psychol Psychiatry. 2011 Oct;16(4):499-516.
4. J Am Acad Child Adolesc Psychiatry. 2008 Dec;47(12):1413-23.
5. International Journal of Transgenderism. 2018;19(2):212-24.
6. Pediatrics. 2016 Mar;137(3):e20153223.
7. J Sex Marital Ther. 2010;36(1):6-23.
8. “Adolescence,” 11th ed. (New York: McGraw-Hill Education; 2016).
9. Graduate Journal of Social Science. 2010;7(2):26-43.
10. “Affirming Gender, Affirming Lives: A Report of the 2011 Transition Survey,” Gender Advocacy Training & Education, 2012.
11. Transgend Health. 2016 Jan;1(1):21-31.
12. Pediatrics. 2014 Oct;134(4):696-704.
New AAP policy statement addresses teen driver risks
The American Academy of Pediatric has issued a policy statement regarding teen drivers because, although becoming a driver is a rite of passage for many, there are unique risks associated with teen drivers – and important ways to address them.
“In 2015, among 15- to 20-year-old individuals, 1,886 young drivers died in MVCs [motor vehicle crashes], which is an increase of 9% from 2014,” the statement explains. “Another 195,000 young drivers were in MVCs, which is up 14% from 2014.”
Risk factors associated with crashes in teenage drivers include their inexperience, the presence of other teens in the car, high-speed and risky driving, distraction, lack of sleep, nighttime driving, and alcohol, marijuana, and medication use. Mobile phones and other electronic devices pose a major threat to driver safety because they contribute opportunities for three different kinds of distraction – visual, manual, and cognitive. Drug and alcohol use poses another threat; for example, tetrahydrocannabinol, found in marijuana, is associated with a 1.25 higher risk of crash, according Elizabeth M. Alderman, MD, and her associates on the Committee on Adolescence and the Council on Injury, Violence, and Poison Prevention who crafted the policy statement.
The policy statement also outlined several interventions to help mitigate these risks. Graduated driver licensing, which has been adopted in all 50 states, has helped reduce teen crashes by promoting skills development and reducing exposure to risky-driving situations. Parents can help model safer-driving practices and set expectations, as well as monitor and affect their teens’ driving behaviors during the supervised-driving phase. Driver education programs, on the other hand, counterintuitively have little effect on teen driving safety, which the authors suggested is because “the knowledge required to pass licensing exams is seldom related to an evidence-based understanding of the behaviors and skills associated with novice driver crash risk.” There also have been technological advances that can help improve driving safety among teenage drivers, such as automatic braking and lane-maintenance alerts.
“Policies, programs, and technologies exist to mitigate these risks but, in most cases, depend on active participation by the teenager and parents,” the authors concluded. “Pediatricians, communities, and governments need to take action to better educate teen drivers and their parents around these risks and strategies to reduce them.”
The full policy statement includes specific recommendations for anticipatory guidance, professional practice, community advocacy, and legislative advocacy. It also includes many resources and links to further information.
SOURCE: Alderman EM et al. Pediatrics. 2018 Oct;142(4):e20182163.
The American Academy of Pediatric has issued a policy statement regarding teen drivers because, although becoming a driver is a rite of passage for many, there are unique risks associated with teen drivers – and important ways to address them.
“In 2015, among 15- to 20-year-old individuals, 1,886 young drivers died in MVCs [motor vehicle crashes], which is an increase of 9% from 2014,” the statement explains. “Another 195,000 young drivers were in MVCs, which is up 14% from 2014.”
Risk factors associated with crashes in teenage drivers include their inexperience, the presence of other teens in the car, high-speed and risky driving, distraction, lack of sleep, nighttime driving, and alcohol, marijuana, and medication use. Mobile phones and other electronic devices pose a major threat to driver safety because they contribute opportunities for three different kinds of distraction – visual, manual, and cognitive. Drug and alcohol use poses another threat; for example, tetrahydrocannabinol, found in marijuana, is associated with a 1.25 higher risk of crash, according Elizabeth M. Alderman, MD, and her associates on the Committee on Adolescence and the Council on Injury, Violence, and Poison Prevention who crafted the policy statement.
The policy statement also outlined several interventions to help mitigate these risks. Graduated driver licensing, which has been adopted in all 50 states, has helped reduce teen crashes by promoting skills development and reducing exposure to risky-driving situations. Parents can help model safer-driving practices and set expectations, as well as monitor and affect their teens’ driving behaviors during the supervised-driving phase. Driver education programs, on the other hand, counterintuitively have little effect on teen driving safety, which the authors suggested is because “the knowledge required to pass licensing exams is seldom related to an evidence-based understanding of the behaviors and skills associated with novice driver crash risk.” There also have been technological advances that can help improve driving safety among teenage drivers, such as automatic braking and lane-maintenance alerts.
“Policies, programs, and technologies exist to mitigate these risks but, in most cases, depend on active participation by the teenager and parents,” the authors concluded. “Pediatricians, communities, and governments need to take action to better educate teen drivers and their parents around these risks and strategies to reduce them.”
The full policy statement includes specific recommendations for anticipatory guidance, professional practice, community advocacy, and legislative advocacy. It also includes many resources and links to further information.
SOURCE: Alderman EM et al. Pediatrics. 2018 Oct;142(4):e20182163.
The American Academy of Pediatric has issued a policy statement regarding teen drivers because, although becoming a driver is a rite of passage for many, there are unique risks associated with teen drivers – and important ways to address them.
“In 2015, among 15- to 20-year-old individuals, 1,886 young drivers died in MVCs [motor vehicle crashes], which is an increase of 9% from 2014,” the statement explains. “Another 195,000 young drivers were in MVCs, which is up 14% from 2014.”
Risk factors associated with crashes in teenage drivers include their inexperience, the presence of other teens in the car, high-speed and risky driving, distraction, lack of sleep, nighttime driving, and alcohol, marijuana, and medication use. Mobile phones and other electronic devices pose a major threat to driver safety because they contribute opportunities for three different kinds of distraction – visual, manual, and cognitive. Drug and alcohol use poses another threat; for example, tetrahydrocannabinol, found in marijuana, is associated with a 1.25 higher risk of crash, according Elizabeth M. Alderman, MD, and her associates on the Committee on Adolescence and the Council on Injury, Violence, and Poison Prevention who crafted the policy statement.
The policy statement also outlined several interventions to help mitigate these risks. Graduated driver licensing, which has been adopted in all 50 states, has helped reduce teen crashes by promoting skills development and reducing exposure to risky-driving situations. Parents can help model safer-driving practices and set expectations, as well as monitor and affect their teens’ driving behaviors during the supervised-driving phase. Driver education programs, on the other hand, counterintuitively have little effect on teen driving safety, which the authors suggested is because “the knowledge required to pass licensing exams is seldom related to an evidence-based understanding of the behaviors and skills associated with novice driver crash risk.” There also have been technological advances that can help improve driving safety among teenage drivers, such as automatic braking and lane-maintenance alerts.
“Policies, programs, and technologies exist to mitigate these risks but, in most cases, depend on active participation by the teenager and parents,” the authors concluded. “Pediatricians, communities, and governments need to take action to better educate teen drivers and their parents around these risks and strategies to reduce them.”
The full policy statement includes specific recommendations for anticipatory guidance, professional practice, community advocacy, and legislative advocacy. It also includes many resources and links to further information.
SOURCE: Alderman EM et al. Pediatrics. 2018 Oct;142(4):e20182163.
FROM PEDIATRICS
Pregnancy registries are a valuable resource
Pregnancy registries are valuable sources of information. For many drugs, they are the primary source of the human pregnancy experience. However, although most of the registries use the word “pregnancy,” it is important to note that many also enroll women who took the target drug shortly before conception.
The strengths of these registries are their prospective nature (enrolled before the outcome is known) and enrollment over a wide geographical area. Typically, two types of pregnancy outcomes are obtained: those with birth defects and those without known birth defects (classified as live births, fetal deaths, and spontaneous abortions). Registries can identify early signals of teratogenicity, but they have several limitations: selection bias that results from voluntary reporting; target populations that are not representative; lost-to-follow-up pregnancies that may have had different outcomes than those with documented outcomes; elective terminations and fetal deaths without birth defects and spontaneous abortions, all of which may lack details; the lack of control groups (with some exceptions); and the publication of results that may be delayed or not be in a peer-reviewed journal. Because the total number of exposed pregnancies is unknown, the data cannot be used to calculate prevalences, but they can be used to estimate the proportion of birth defects. Some registries also collect data on retrospective reports (reported after outcome is known). Such reports are less representative of the target population because they can be biased toward the reporting of more unusual and severe outcomes. But they may be helpful in detecting unusual patterns of birth defects.
For the following drugs, web addresses can be obtained from the Food and Drug Administration website, List of Pregnancy Exposure Registries.
MotherToBaby
A large registry, the MotherToBaby Organization of Teratology Information Specialists (OTIS) (877-311-8972), involves patients in several different categories and the effects of the drugs on the embryo-fetus: autoimmune diseases (ankylosing spondylitis, rheumatoid arthritis, psoriatic arthritis, ulcerative colitis, psoriasis, Crohn’s disease, and multiple sclerosis); asthma at less than 20 weeks’ gestation; vaccines; and heterozygous or homozygous familial hypercholesterolemia.
For the autoimmune diseases, the drugs and trade names are abatacept (Orencia), adalimumab (Humira), certolizumab pegol (Cimzia), etanercept (Enbrel), infliximab (Remicade), leflunomide (Arava), otezla (Apremilast), teriflunomide (Aubagio), tocilizumab (Actemra), tofacitinib (Xeljanz), and ustekinumab (Stelara).
For the asthma group, the drug being investigated is mepolizumab (Nucala).
Two vaccines – for tetanus, diphtheria, and pertussis (Tdap) and meningococcal disease caused by Neisseria meningitidis serogroups A, C, Y and W-135 (Menveo) – are being studied.
The last category is heterozygous or homozygous familial hypercholesterolemia. The two agents in this category are alirocumab (Praluent) and evolocumab (Repatha).
Other registries
Breast cancer
The Mother Pregnancy Registry, INC Research (800-690-6720), is enrolling breast cancer patients who have been treated during pregnancy with ado-trastuzumab emtansine (Kadcyla), pertuzumab (Perjeta), or trastuzumab (Herceptin).
Epilepsy
The Antiepileptic Drug Pregnancy registry (888-233-2334) is studying eslicarbazepine (Aptiom) and pregabalin (Lyrica).
Fabry disease
The Fabry Registry, Genzyme Corp (617-591-5500) is studying the use in pregnancy of agalsidase beta (Fabrazyme) for Fabry disease.
Fibromyalgia
The Savella Pregnancy Registry (877-643-3010) is looking for patients with fibromyalgia who are being treated with milnacipran (Savella).
Hepatitis B
The Ribavirin Pregnancy Registry, INC Research (800-593-2214) is looking for subjects with hepatitis C who have been treated with ribavirin (Copegus).
Hypercholesterolemia
Lomitapide (Juxtapid) is being studied by the Global Lomitapide Pregnancy Exposure Registry managed by Aegerion (877-902-4099). The drug is used for homozygous familial hypercholesterolemia.
Mucopolysaccharidosis
The Mucopolysaccharidosis I (MPS I) registry, Genzyme (617-591-5500) is studying the use of laronidase (Aldurazyme) for Hurler syndrome, Scheie syndrome, and Hurler-Scheie syndrome.
The use of galsulfase (Naglazyme) for Maroteaux-Lamy syndrome during pregnancy is under study by the Mucopolysaccharidosis VI (MPS VI), clinical surveillance program (BioMarin Pharmaceutical) (415-506-6849 or 415-506-6703).
Multiple sclerosis
Novartis is conducting the Gilenya Pregnancy Registry (877-598-7237) for patients with multiple sclerosis who are taking fingolimod (Gilenya).
Alemtuzumab (Lemtrada), also indicated for multiple sclerosis, is the target agent for the LEMTRADA Pregnancy Exposure Registry (866-758-2990).
Narcolepsy and other sleep disorders
Armodafinil (Nuvigil), used for excessive sleepiness associated with narcolepsy and other sleep disorders, is being studied in the Nuvigil Pregnancy Registry (866-404-4106). A second drug with the same indication and telephone number, modafinil (Provigil), is in the Provigil Pregnancy Registry.
Osteoporosis
Amgen’s Pregnancy Surveillance Program (800-772-6436) is enrolling pregnant subjects with osteoporosis who are being treated with denosumab (Prolia).
Others
Two Merck pregnancy registries (800-986-8999) cover the following conditions: type 2 diabetes sitagliptin+metformin (Janumet) or sitagliptin (Januvia); and migraine headaches rizatriptan (Maxalt).
GlaxoSmithKline is conducting two registries: the Belimumab Pregnancy Registry for patients with systemic lupus erythematosus treated with belimumab (Benlysta) (877-681-6296); and Promacta Pregnancy Registry for women treated for thrombocytopenia with eltrombopag (Promacta) (888-825-5249).
Psychiatric Drugs
The National Pregnancy Registry for Atypical Antipsychotics (866-961-2388) is studying 10 drugs: aripiprazole (Abilify), asenapine (Saphris), clozapine (Clozaril), iloperidone (Fanapt), lurasidone (Latuda), olanzapine (Zyprexa), paliperidone (Invega), quetiapine (Seroquel), risperidone (Risperdal), and ziprasidone (Geodon).
The National Pregnancy Registry for Antidepressants (844-405-6185) is studying amitriptyline (Elavil), amoxapine (Asendin), bupropion (Forfivo XL and Wellbutrin), citalopram (Celexa), clomipramine (Anafranil), desipramine (Norpramin), desvenlafaxine (Prisiq), doxepin (Sinequan), escitalopram (Lexapro), fluvoxamine (Luvox), fluoxetine (Prozac), imipramine (Tofranil), isocarboxazid (Marplan), levomilnacipran (Fetzima), maprotiline (Ludiomil), mirtazapine (Remeron), nefazodone (Serzone), nortriptyline (Pamelor), paroxetine (Paxil), phenelzine (Nardill), protriptyline (Vivactil), selegiline (Emsam), sertraline (Zoloft), tranylcypromine (Pamate), trazodone (Desyrel), trimipramine (Surmontil), venlafaxine (Effexor), and vilazodone (Viibryd).
The National Pregnancy Registry of Psychostimulants (866-961-2388) is studying amphetamine (Adderall), dextroamphetamine (Dexedrine and Focalin), lisdexamfetamine (Vyvanse), methylphenidate (Concerta, Daytrana, Desoxyn, Ritalin), and modafinil (Provigil).
The antidepressant duloxetine (Cymbalta) is being studied by the Cymbalta Pregnancy Registry (866-814-6975).
Transplant patients
Renal transplant patients exposed to mycophenolate (CellCept) can be enrolled in the Transplantation Pregnancy Registry International (877-955-6877) or the Mycophenolate Pregnancy Registry (800-617-8191). The Transplantation Pregnancy Registry International also is enrolling renal transplant patients exposed to belatacept (Nulojix).
Vaccines
A quadrivalent influenza vaccine (Afluria) is being studied by the Seqirus Influenza Vaccine Pregnancy Registry (855-358-8972). A second vaccine for meningococcal disease meningococcal disease caused by Neisseria meningitidis serogroups A, C, Y and W-135 (Menactra) is under study by the Menactra Vaccine Pregnancy Registry (800-822-2463). The Bexsero Pregnancy Registry (877-413-4759) is open to patients who have received the meningococcal group B vaccine (Bexsero). The Hepatitis B Vaccine [Recombinant] Adjuvanted Pregnancy Registry, also listed as HEPLISAV-B, is enrolling patients who have received that vaccine (844-443-7734); it is supported by the Dynavax Technologies Corporation.
Because the strength of a registry is based on numbers, health care professionals are encouraged to enroll potential subjects or have their patients call to enroll themselves.
Mr. Briggs is clinical professor of pharmacy at the University of California, San Francisco, and adjunct professor of pharmacy at the University of Southern California, Los Angeles, as well as at Washington State University, Spokane. Mr. Briggs said he had no relevant financial disclosures. Email him at [email protected].
Pregnancy registries are valuable sources of information. For many drugs, they are the primary source of the human pregnancy experience. However, although most of the registries use the word “pregnancy,” it is important to note that many also enroll women who took the target drug shortly before conception.
The strengths of these registries are their prospective nature (enrolled before the outcome is known) and enrollment over a wide geographical area. Typically, two types of pregnancy outcomes are obtained: those with birth defects and those without known birth defects (classified as live births, fetal deaths, and spontaneous abortions). Registries can identify early signals of teratogenicity, but they have several limitations: selection bias that results from voluntary reporting; target populations that are not representative; lost-to-follow-up pregnancies that may have had different outcomes than those with documented outcomes; elective terminations and fetal deaths without birth defects and spontaneous abortions, all of which may lack details; the lack of control groups (with some exceptions); and the publication of results that may be delayed or not be in a peer-reviewed journal. Because the total number of exposed pregnancies is unknown, the data cannot be used to calculate prevalences, but they can be used to estimate the proportion of birth defects. Some registries also collect data on retrospective reports (reported after outcome is known). Such reports are less representative of the target population because they can be biased toward the reporting of more unusual and severe outcomes. But they may be helpful in detecting unusual patterns of birth defects.
For the following drugs, web addresses can be obtained from the Food and Drug Administration website, List of Pregnancy Exposure Registries.
MotherToBaby
A large registry, the MotherToBaby Organization of Teratology Information Specialists (OTIS) (877-311-8972), involves patients in several different categories and the effects of the drugs on the embryo-fetus: autoimmune diseases (ankylosing spondylitis, rheumatoid arthritis, psoriatic arthritis, ulcerative colitis, psoriasis, Crohn’s disease, and multiple sclerosis); asthma at less than 20 weeks’ gestation; vaccines; and heterozygous or homozygous familial hypercholesterolemia.
For the autoimmune diseases, the drugs and trade names are abatacept (Orencia), adalimumab (Humira), certolizumab pegol (Cimzia), etanercept (Enbrel), infliximab (Remicade), leflunomide (Arava), otezla (Apremilast), teriflunomide (Aubagio), tocilizumab (Actemra), tofacitinib (Xeljanz), and ustekinumab (Stelara).
For the asthma group, the drug being investigated is mepolizumab (Nucala).
Two vaccines – for tetanus, diphtheria, and pertussis (Tdap) and meningococcal disease caused by Neisseria meningitidis serogroups A, C, Y and W-135 (Menveo) – are being studied.
The last category is heterozygous or homozygous familial hypercholesterolemia. The two agents in this category are alirocumab (Praluent) and evolocumab (Repatha).
Other registries
Breast cancer
The Mother Pregnancy Registry, INC Research (800-690-6720), is enrolling breast cancer patients who have been treated during pregnancy with ado-trastuzumab emtansine (Kadcyla), pertuzumab (Perjeta), or trastuzumab (Herceptin).
Epilepsy
The Antiepileptic Drug Pregnancy registry (888-233-2334) is studying eslicarbazepine (Aptiom) and pregabalin (Lyrica).
Fabry disease
The Fabry Registry, Genzyme Corp (617-591-5500) is studying the use in pregnancy of agalsidase beta (Fabrazyme) for Fabry disease.
Fibromyalgia
The Savella Pregnancy Registry (877-643-3010) is looking for patients with fibromyalgia who are being treated with milnacipran (Savella).
Hepatitis B
The Ribavirin Pregnancy Registry, INC Research (800-593-2214) is looking for subjects with hepatitis C who have been treated with ribavirin (Copegus).
Hypercholesterolemia
Lomitapide (Juxtapid) is being studied by the Global Lomitapide Pregnancy Exposure Registry managed by Aegerion (877-902-4099). The drug is used for homozygous familial hypercholesterolemia.
Mucopolysaccharidosis
The Mucopolysaccharidosis I (MPS I) registry, Genzyme (617-591-5500) is studying the use of laronidase (Aldurazyme) for Hurler syndrome, Scheie syndrome, and Hurler-Scheie syndrome.
The use of galsulfase (Naglazyme) for Maroteaux-Lamy syndrome during pregnancy is under study by the Mucopolysaccharidosis VI (MPS VI), clinical surveillance program (BioMarin Pharmaceutical) (415-506-6849 or 415-506-6703).
Multiple sclerosis
Novartis is conducting the Gilenya Pregnancy Registry (877-598-7237) for patients with multiple sclerosis who are taking fingolimod (Gilenya).
Alemtuzumab (Lemtrada), also indicated for multiple sclerosis, is the target agent for the LEMTRADA Pregnancy Exposure Registry (866-758-2990).
Narcolepsy and other sleep disorders
Armodafinil (Nuvigil), used for excessive sleepiness associated with narcolepsy and other sleep disorders, is being studied in the Nuvigil Pregnancy Registry (866-404-4106). A second drug with the same indication and telephone number, modafinil (Provigil), is in the Provigil Pregnancy Registry.
Osteoporosis
Amgen’s Pregnancy Surveillance Program (800-772-6436) is enrolling pregnant subjects with osteoporosis who are being treated with denosumab (Prolia).
Others
Two Merck pregnancy registries (800-986-8999) cover the following conditions: type 2 diabetes sitagliptin+metformin (Janumet) or sitagliptin (Januvia); and migraine headaches rizatriptan (Maxalt).
GlaxoSmithKline is conducting two registries: the Belimumab Pregnancy Registry for patients with systemic lupus erythematosus treated with belimumab (Benlysta) (877-681-6296); and Promacta Pregnancy Registry for women treated for thrombocytopenia with eltrombopag (Promacta) (888-825-5249).
Psychiatric Drugs
The National Pregnancy Registry for Atypical Antipsychotics (866-961-2388) is studying 10 drugs: aripiprazole (Abilify), asenapine (Saphris), clozapine (Clozaril), iloperidone (Fanapt), lurasidone (Latuda), olanzapine (Zyprexa), paliperidone (Invega), quetiapine (Seroquel), risperidone (Risperdal), and ziprasidone (Geodon).
The National Pregnancy Registry for Antidepressants (844-405-6185) is studying amitriptyline (Elavil), amoxapine (Asendin), bupropion (Forfivo XL and Wellbutrin), citalopram (Celexa), clomipramine (Anafranil), desipramine (Norpramin), desvenlafaxine (Prisiq), doxepin (Sinequan), escitalopram (Lexapro), fluvoxamine (Luvox), fluoxetine (Prozac), imipramine (Tofranil), isocarboxazid (Marplan), levomilnacipran (Fetzima), maprotiline (Ludiomil), mirtazapine (Remeron), nefazodone (Serzone), nortriptyline (Pamelor), paroxetine (Paxil), phenelzine (Nardill), protriptyline (Vivactil), selegiline (Emsam), sertraline (Zoloft), tranylcypromine (Pamate), trazodone (Desyrel), trimipramine (Surmontil), venlafaxine (Effexor), and vilazodone (Viibryd).
The National Pregnancy Registry of Psychostimulants (866-961-2388) is studying amphetamine (Adderall), dextroamphetamine (Dexedrine and Focalin), lisdexamfetamine (Vyvanse), methylphenidate (Concerta, Daytrana, Desoxyn, Ritalin), and modafinil (Provigil).
The antidepressant duloxetine (Cymbalta) is being studied by the Cymbalta Pregnancy Registry (866-814-6975).
Transplant patients
Renal transplant patients exposed to mycophenolate (CellCept) can be enrolled in the Transplantation Pregnancy Registry International (877-955-6877) or the Mycophenolate Pregnancy Registry (800-617-8191). The Transplantation Pregnancy Registry International also is enrolling renal transplant patients exposed to belatacept (Nulojix).
Vaccines
A quadrivalent influenza vaccine (Afluria) is being studied by the Seqirus Influenza Vaccine Pregnancy Registry (855-358-8972). A second vaccine for meningococcal disease meningococcal disease caused by Neisseria meningitidis serogroups A, C, Y and W-135 (Menactra) is under study by the Menactra Vaccine Pregnancy Registry (800-822-2463). The Bexsero Pregnancy Registry (877-413-4759) is open to patients who have received the meningococcal group B vaccine (Bexsero). The Hepatitis B Vaccine [Recombinant] Adjuvanted Pregnancy Registry, also listed as HEPLISAV-B, is enrolling patients who have received that vaccine (844-443-7734); it is supported by the Dynavax Technologies Corporation.
Because the strength of a registry is based on numbers, health care professionals are encouraged to enroll potential subjects or have their patients call to enroll themselves.
Mr. Briggs is clinical professor of pharmacy at the University of California, San Francisco, and adjunct professor of pharmacy at the University of Southern California, Los Angeles, as well as at Washington State University, Spokane. Mr. Briggs said he had no relevant financial disclosures. Email him at [email protected].
Pregnancy registries are valuable sources of information. For many drugs, they are the primary source of the human pregnancy experience. However, although most of the registries use the word “pregnancy,” it is important to note that many also enroll women who took the target drug shortly before conception.
The strengths of these registries are their prospective nature (enrolled before the outcome is known) and enrollment over a wide geographical area. Typically, two types of pregnancy outcomes are obtained: those with birth defects and those without known birth defects (classified as live births, fetal deaths, and spontaneous abortions). Registries can identify early signals of teratogenicity, but they have several limitations: selection bias that results from voluntary reporting; target populations that are not representative; lost-to-follow-up pregnancies that may have had different outcomes than those with documented outcomes; elective terminations and fetal deaths without birth defects and spontaneous abortions, all of which may lack details; the lack of control groups (with some exceptions); and the publication of results that may be delayed or not be in a peer-reviewed journal. Because the total number of exposed pregnancies is unknown, the data cannot be used to calculate prevalences, but they can be used to estimate the proportion of birth defects. Some registries also collect data on retrospective reports (reported after outcome is known). Such reports are less representative of the target population because they can be biased toward the reporting of more unusual and severe outcomes. But they may be helpful in detecting unusual patterns of birth defects.
For the following drugs, web addresses can be obtained from the Food and Drug Administration website, List of Pregnancy Exposure Registries.
MotherToBaby
A large registry, the MotherToBaby Organization of Teratology Information Specialists (OTIS) (877-311-8972), involves patients in several different categories and the effects of the drugs on the embryo-fetus: autoimmune diseases (ankylosing spondylitis, rheumatoid arthritis, psoriatic arthritis, ulcerative colitis, psoriasis, Crohn’s disease, and multiple sclerosis); asthma at less than 20 weeks’ gestation; vaccines; and heterozygous or homozygous familial hypercholesterolemia.
For the autoimmune diseases, the drugs and trade names are abatacept (Orencia), adalimumab (Humira), certolizumab pegol (Cimzia), etanercept (Enbrel), infliximab (Remicade), leflunomide (Arava), otezla (Apremilast), teriflunomide (Aubagio), tocilizumab (Actemra), tofacitinib (Xeljanz), and ustekinumab (Stelara).
For the asthma group, the drug being investigated is mepolizumab (Nucala).
Two vaccines – for tetanus, diphtheria, and pertussis (Tdap) and meningococcal disease caused by Neisseria meningitidis serogroups A, C, Y and W-135 (Menveo) – are being studied.
The last category is heterozygous or homozygous familial hypercholesterolemia. The two agents in this category are alirocumab (Praluent) and evolocumab (Repatha).
Other registries
Breast cancer
The Mother Pregnancy Registry, INC Research (800-690-6720), is enrolling breast cancer patients who have been treated during pregnancy with ado-trastuzumab emtansine (Kadcyla), pertuzumab (Perjeta), or trastuzumab (Herceptin).
Epilepsy
The Antiepileptic Drug Pregnancy registry (888-233-2334) is studying eslicarbazepine (Aptiom) and pregabalin (Lyrica).
Fabry disease
The Fabry Registry, Genzyme Corp (617-591-5500) is studying the use in pregnancy of agalsidase beta (Fabrazyme) for Fabry disease.
Fibromyalgia
The Savella Pregnancy Registry (877-643-3010) is looking for patients with fibromyalgia who are being treated with milnacipran (Savella).
Hepatitis B
The Ribavirin Pregnancy Registry, INC Research (800-593-2214) is looking for subjects with hepatitis C who have been treated with ribavirin (Copegus).
Hypercholesterolemia
Lomitapide (Juxtapid) is being studied by the Global Lomitapide Pregnancy Exposure Registry managed by Aegerion (877-902-4099). The drug is used for homozygous familial hypercholesterolemia.
Mucopolysaccharidosis
The Mucopolysaccharidosis I (MPS I) registry, Genzyme (617-591-5500) is studying the use of laronidase (Aldurazyme) for Hurler syndrome, Scheie syndrome, and Hurler-Scheie syndrome.
The use of galsulfase (Naglazyme) for Maroteaux-Lamy syndrome during pregnancy is under study by the Mucopolysaccharidosis VI (MPS VI), clinical surveillance program (BioMarin Pharmaceutical) (415-506-6849 or 415-506-6703).
Multiple sclerosis
Novartis is conducting the Gilenya Pregnancy Registry (877-598-7237) for patients with multiple sclerosis who are taking fingolimod (Gilenya).
Alemtuzumab (Lemtrada), also indicated for multiple sclerosis, is the target agent for the LEMTRADA Pregnancy Exposure Registry (866-758-2990).
Narcolepsy and other sleep disorders
Armodafinil (Nuvigil), used for excessive sleepiness associated with narcolepsy and other sleep disorders, is being studied in the Nuvigil Pregnancy Registry (866-404-4106). A second drug with the same indication and telephone number, modafinil (Provigil), is in the Provigil Pregnancy Registry.
Osteoporosis
Amgen’s Pregnancy Surveillance Program (800-772-6436) is enrolling pregnant subjects with osteoporosis who are being treated with denosumab (Prolia).
Others
Two Merck pregnancy registries (800-986-8999) cover the following conditions: type 2 diabetes sitagliptin+metformin (Janumet) or sitagliptin (Januvia); and migraine headaches rizatriptan (Maxalt).
GlaxoSmithKline is conducting two registries: the Belimumab Pregnancy Registry for patients with systemic lupus erythematosus treated with belimumab (Benlysta) (877-681-6296); and Promacta Pregnancy Registry for women treated for thrombocytopenia with eltrombopag (Promacta) (888-825-5249).
Psychiatric Drugs
The National Pregnancy Registry for Atypical Antipsychotics (866-961-2388) is studying 10 drugs: aripiprazole (Abilify), asenapine (Saphris), clozapine (Clozaril), iloperidone (Fanapt), lurasidone (Latuda), olanzapine (Zyprexa), paliperidone (Invega), quetiapine (Seroquel), risperidone (Risperdal), and ziprasidone (Geodon).
The National Pregnancy Registry for Antidepressants (844-405-6185) is studying amitriptyline (Elavil), amoxapine (Asendin), bupropion (Forfivo XL and Wellbutrin), citalopram (Celexa), clomipramine (Anafranil), desipramine (Norpramin), desvenlafaxine (Prisiq), doxepin (Sinequan), escitalopram (Lexapro), fluvoxamine (Luvox), fluoxetine (Prozac), imipramine (Tofranil), isocarboxazid (Marplan), levomilnacipran (Fetzima), maprotiline (Ludiomil), mirtazapine (Remeron), nefazodone (Serzone), nortriptyline (Pamelor), paroxetine (Paxil), phenelzine (Nardill), protriptyline (Vivactil), selegiline (Emsam), sertraline (Zoloft), tranylcypromine (Pamate), trazodone (Desyrel), trimipramine (Surmontil), venlafaxine (Effexor), and vilazodone (Viibryd).
The National Pregnancy Registry of Psychostimulants (866-961-2388) is studying amphetamine (Adderall), dextroamphetamine (Dexedrine and Focalin), lisdexamfetamine (Vyvanse), methylphenidate (Concerta, Daytrana, Desoxyn, Ritalin), and modafinil (Provigil).
The antidepressant duloxetine (Cymbalta) is being studied by the Cymbalta Pregnancy Registry (866-814-6975).
Transplant patients
Renal transplant patients exposed to mycophenolate (CellCept) can be enrolled in the Transplantation Pregnancy Registry International (877-955-6877) or the Mycophenolate Pregnancy Registry (800-617-8191). The Transplantation Pregnancy Registry International also is enrolling renal transplant patients exposed to belatacept (Nulojix).
Vaccines
A quadrivalent influenza vaccine (Afluria) is being studied by the Seqirus Influenza Vaccine Pregnancy Registry (855-358-8972). A second vaccine for meningococcal disease meningococcal disease caused by Neisseria meningitidis serogroups A, C, Y and W-135 (Menactra) is under study by the Menactra Vaccine Pregnancy Registry (800-822-2463). The Bexsero Pregnancy Registry (877-413-4759) is open to patients who have received the meningococcal group B vaccine (Bexsero). The Hepatitis B Vaccine [Recombinant] Adjuvanted Pregnancy Registry, also listed as HEPLISAV-B, is enrolling patients who have received that vaccine (844-443-7734); it is supported by the Dynavax Technologies Corporation.
Because the strength of a registry is based on numbers, health care professionals are encouraged to enroll potential subjects or have their patients call to enroll themselves.
Mr. Briggs is clinical professor of pharmacy at the University of California, San Francisco, and adjunct professor of pharmacy at the University of Southern California, Los Angeles, as well as at Washington State University, Spokane. Mr. Briggs said he had no relevant financial disclosures. Email him at [email protected].
What’s in that e-cigarette? It may be cannabis
Nearly 1 in 11 U.S. middle and high school students have used a cannabis product in an e-cigarette, according to a school-based survey of 20,675 students.
The survey found that 8.9% of students in grades 6-12 said they had used an e-cigarette with marijuana, tetrahydrocannabinol or hash oil, or tetrahydrocannabinol wax. Among the students who reported ever using e-cigarettes, 30.6% had used a cannabis product in the device. The findings were published in JAMA Pediatrics.
This translated to around 1.7 million high school students and 425,000 middle school students who had ever used cannabis in e-cigarettes; figures the authors said were consistent with or higher than previous reports among U.S. and Canadian students.
Katrina F. Trivers, PhD, and her colleagues from the Centers for Disease Control and Prevention, noted that the U.S. Surgeon General has found e-cigarette aerosol can contain potentially harmful ingredients. Additionally, the National Academies of Sciences has said youth cannabis use can harm learning and memory.
“Strategies to reduce cannabis use in e-cigarettes are critical for protecting young people from these potential health risks,” the researchers wrote.
Male students and high school students were significantly more likely to report using cannabis products in an e-cigarette (10.6% and 12.4%, respectively), compared with female or middle school students.
Among current users of e-cigarettes, 39.5% reported using cannabis in the e-cigarette, while among those who used other tobacco products, 38.5% used cannabis in e-cigarettes. Higher e-cigarette use was also associated with use of cannabis products in e-cigarettes.
Living with someone who used tobacco products was associated with a higher incidence of cannabis in e-cigarette use (13%). Researchers also saw a higher use of cannabis in e-cigarettes among students of Hispanic ethnicity, compared with other ethnicities.
In 2015, around one-third of U.S. middle and high school students said they had used nonnicotine substances in e-cigarettes, but the use of cannabis in e-cigarettes could increase as several states consider legalizing cannabis sales for adults. “Given the high concurrent use of tobacco and other substances, it is important to monitor the substances youth use in e-cigarettes,” they wrote.
The researchers reported having no financial disclosures.
SOURCE: Trivers KF et al. JAMA Pediatr. 2018 Sep 17. doi: 10.1001/jamapediatrics.2018.1920.
Nearly 1 in 11 U.S. middle and high school students have used a cannabis product in an e-cigarette, according to a school-based survey of 20,675 students.
The survey found that 8.9% of students in grades 6-12 said they had used an e-cigarette with marijuana, tetrahydrocannabinol or hash oil, or tetrahydrocannabinol wax. Among the students who reported ever using e-cigarettes, 30.6% had used a cannabis product in the device. The findings were published in JAMA Pediatrics.
This translated to around 1.7 million high school students and 425,000 middle school students who had ever used cannabis in e-cigarettes; figures the authors said were consistent with or higher than previous reports among U.S. and Canadian students.
Katrina F. Trivers, PhD, and her colleagues from the Centers for Disease Control and Prevention, noted that the U.S. Surgeon General has found e-cigarette aerosol can contain potentially harmful ingredients. Additionally, the National Academies of Sciences has said youth cannabis use can harm learning and memory.
“Strategies to reduce cannabis use in e-cigarettes are critical for protecting young people from these potential health risks,” the researchers wrote.
Male students and high school students were significantly more likely to report using cannabis products in an e-cigarette (10.6% and 12.4%, respectively), compared with female or middle school students.
Among current users of e-cigarettes, 39.5% reported using cannabis in the e-cigarette, while among those who used other tobacco products, 38.5% used cannabis in e-cigarettes. Higher e-cigarette use was also associated with use of cannabis products in e-cigarettes.
Living with someone who used tobacco products was associated with a higher incidence of cannabis in e-cigarette use (13%). Researchers also saw a higher use of cannabis in e-cigarettes among students of Hispanic ethnicity, compared with other ethnicities.
In 2015, around one-third of U.S. middle and high school students said they had used nonnicotine substances in e-cigarettes, but the use of cannabis in e-cigarettes could increase as several states consider legalizing cannabis sales for adults. “Given the high concurrent use of tobacco and other substances, it is important to monitor the substances youth use in e-cigarettes,” they wrote.
The researchers reported having no financial disclosures.
SOURCE: Trivers KF et al. JAMA Pediatr. 2018 Sep 17. doi: 10.1001/jamapediatrics.2018.1920.
Nearly 1 in 11 U.S. middle and high school students have used a cannabis product in an e-cigarette, according to a school-based survey of 20,675 students.
The survey found that 8.9% of students in grades 6-12 said they had used an e-cigarette with marijuana, tetrahydrocannabinol or hash oil, or tetrahydrocannabinol wax. Among the students who reported ever using e-cigarettes, 30.6% had used a cannabis product in the device. The findings were published in JAMA Pediatrics.
This translated to around 1.7 million high school students and 425,000 middle school students who had ever used cannabis in e-cigarettes; figures the authors said were consistent with or higher than previous reports among U.S. and Canadian students.
Katrina F. Trivers, PhD, and her colleagues from the Centers for Disease Control and Prevention, noted that the U.S. Surgeon General has found e-cigarette aerosol can contain potentially harmful ingredients. Additionally, the National Academies of Sciences has said youth cannabis use can harm learning and memory.
“Strategies to reduce cannabis use in e-cigarettes are critical for protecting young people from these potential health risks,” the researchers wrote.
Male students and high school students were significantly more likely to report using cannabis products in an e-cigarette (10.6% and 12.4%, respectively), compared with female or middle school students.
Among current users of e-cigarettes, 39.5% reported using cannabis in the e-cigarette, while among those who used other tobacco products, 38.5% used cannabis in e-cigarettes. Higher e-cigarette use was also associated with use of cannabis products in e-cigarettes.
Living with someone who used tobacco products was associated with a higher incidence of cannabis in e-cigarette use (13%). Researchers also saw a higher use of cannabis in e-cigarettes among students of Hispanic ethnicity, compared with other ethnicities.
In 2015, around one-third of U.S. middle and high school students said they had used nonnicotine substances in e-cigarettes, but the use of cannabis in e-cigarettes could increase as several states consider legalizing cannabis sales for adults. “Given the high concurrent use of tobacco and other substances, it is important to monitor the substances youth use in e-cigarettes,” they wrote.
The researchers reported having no financial disclosures.
SOURCE: Trivers KF et al. JAMA Pediatr. 2018 Sep 17. doi: 10.1001/jamapediatrics.2018.1920.
FROM JAMA PEDIATRICS
Key clinical point:
Major finding: A survey of U.S. students showed that 8.9% have used cannabis in an e-cigarette. Among e-cigarette users, cannabis use in e-cigarettes was reported by 30.6% of students.
Study details: A school-based survey of 20,675 students.
Disclosures: The researchers reported having no financial disclosures.
Source: Trivers KF et al. JAMA Pediatr. 2018 Sep 17. doi: 10.1001/jamapediatrics.2018.1920.
Pediatricians fall short on transition to adult care
Many adolescent patients, both with and without special health care needs, are not receiving guidance from their physicians about transitioning to adult care, according to recent findings published in Pediatrics.
Lydie A. Lebrun-Harris, PhD, of the Maternal and Child Health Bureau at the Health Resources and Services Administration, and her colleagues examined data from 20,708 youth aged 12-17 years with and without special health care needs obtained from the 2016 National Survey of Children’s Health. The aim was to determine the current level of transition planning to adult care from a pediatric or other health care provider (HCP).
Parents and caregivers were asked whether a doctor or HCP had spent time alone with the adolescent during the last year, had discussed the transition to adult care, and had actively helped the adolescent “gain self-care skills or understand changes in health care” when they reached the age of 18 years.
Overall, 17% of youth with special health care needs and 14% of youth without met all three transition elements.
The figures were higher for individual measures. For instance, 44% of youth with special health care needs spent time alone with an HCP within the past year, 41% discussed transition to an adult provider, and 69% reported an HCP had worked with them to understand health care changes and gain self-care skills.
Youth without special health care needs were more likely to discus the shift to adult care with HCPs than those with special needs, but special needs youth were more likely to have met the other two transition measurements (P less than .001).
Being older (aged 15-17 years) were associated with an increased prevalence of meeting the overall transition measure and the individual elements among both youth with and without special health care needs.
“Findings from this study underscore the urgent need for HCPs to work with youth independently and in collaboration with their parents and/or caregivers throughout the adolescent years to improve transition planning,” Dr. Lebrun-Harris and her colleagues wrote.
The study was supported by the Health Resources and Services Administration and the National Alliance to Advance Adolescent Health. The authors reported having no relevant conflicts of interest.
SOURCE: Lebrun-Harris LA et al. Pediatrics. 2018 Sep 17. doi: 10.1542/peds.2018-0194.
While researchers and clinicians have been discussing how to improve the poor health outcomes seen in the transition from pediatric to adult care for youth with special health care needs for decades, there has been little improvement, Megumi J. Okumura, MD, wrote in an accompanying editorial.
In 2016, 41% of youth with special health care needs had a discussion about the transition from pediatric to adult care, a figure that is “largely unchanged from 2010,” she noted.
One hurdle is the lack of a gold standard for measuring an ideal transition. Is it successful scheduling of an appointment with adult provider or having a job and being able to manage one’s own disease?
“Until our health system supports pediatric providers in offering adequate transition planning, it will be difficult to expect any uptick in these measures. In addition, we still need to understand why some adolescents fail in their transition and transfer and how to develop the appropriate interventions to improve health outcomes for these patients,” Dr. Okumura wrote.
Dr. Okumura is with the division of general pediatrics at the University of California, San Francisco. These comments are adapted from an accompanying editorial (Pediatrics. 2018 Sep 17. doi: 10.1542/peds.2018-2245). She reported having no relevant conflicts of interest.
While researchers and clinicians have been discussing how to improve the poor health outcomes seen in the transition from pediatric to adult care for youth with special health care needs for decades, there has been little improvement, Megumi J. Okumura, MD, wrote in an accompanying editorial.
In 2016, 41% of youth with special health care needs had a discussion about the transition from pediatric to adult care, a figure that is “largely unchanged from 2010,” she noted.
One hurdle is the lack of a gold standard for measuring an ideal transition. Is it successful scheduling of an appointment with adult provider or having a job and being able to manage one’s own disease?
“Until our health system supports pediatric providers in offering adequate transition planning, it will be difficult to expect any uptick in these measures. In addition, we still need to understand why some adolescents fail in their transition and transfer and how to develop the appropriate interventions to improve health outcomes for these patients,” Dr. Okumura wrote.
Dr. Okumura is with the division of general pediatrics at the University of California, San Francisco. These comments are adapted from an accompanying editorial (Pediatrics. 2018 Sep 17. doi: 10.1542/peds.2018-2245). She reported having no relevant conflicts of interest.
While researchers and clinicians have been discussing how to improve the poor health outcomes seen in the transition from pediatric to adult care for youth with special health care needs for decades, there has been little improvement, Megumi J. Okumura, MD, wrote in an accompanying editorial.
In 2016, 41% of youth with special health care needs had a discussion about the transition from pediatric to adult care, a figure that is “largely unchanged from 2010,” she noted.
One hurdle is the lack of a gold standard for measuring an ideal transition. Is it successful scheduling of an appointment with adult provider or having a job and being able to manage one’s own disease?
“Until our health system supports pediatric providers in offering adequate transition planning, it will be difficult to expect any uptick in these measures. In addition, we still need to understand why some adolescents fail in their transition and transfer and how to develop the appropriate interventions to improve health outcomes for these patients,” Dr. Okumura wrote.
Dr. Okumura is with the division of general pediatrics at the University of California, San Francisco. These comments are adapted from an accompanying editorial (Pediatrics. 2018 Sep 17. doi: 10.1542/peds.2018-2245). She reported having no relevant conflicts of interest.
Many adolescent patients, both with and without special health care needs, are not receiving guidance from their physicians about transitioning to adult care, according to recent findings published in Pediatrics.
Lydie A. Lebrun-Harris, PhD, of the Maternal and Child Health Bureau at the Health Resources and Services Administration, and her colleagues examined data from 20,708 youth aged 12-17 years with and without special health care needs obtained from the 2016 National Survey of Children’s Health. The aim was to determine the current level of transition planning to adult care from a pediatric or other health care provider (HCP).
Parents and caregivers were asked whether a doctor or HCP had spent time alone with the adolescent during the last year, had discussed the transition to adult care, and had actively helped the adolescent “gain self-care skills or understand changes in health care” when they reached the age of 18 years.
Overall, 17% of youth with special health care needs and 14% of youth without met all three transition elements.
The figures were higher for individual measures. For instance, 44% of youth with special health care needs spent time alone with an HCP within the past year, 41% discussed transition to an adult provider, and 69% reported an HCP had worked with them to understand health care changes and gain self-care skills.
Youth without special health care needs were more likely to discus the shift to adult care with HCPs than those with special needs, but special needs youth were more likely to have met the other two transition measurements (P less than .001).
Being older (aged 15-17 years) were associated with an increased prevalence of meeting the overall transition measure and the individual elements among both youth with and without special health care needs.
“Findings from this study underscore the urgent need for HCPs to work with youth independently and in collaboration with their parents and/or caregivers throughout the adolescent years to improve transition planning,” Dr. Lebrun-Harris and her colleagues wrote.
The study was supported by the Health Resources and Services Administration and the National Alliance to Advance Adolescent Health. The authors reported having no relevant conflicts of interest.
SOURCE: Lebrun-Harris LA et al. Pediatrics. 2018 Sep 17. doi: 10.1542/peds.2018-0194.
Many adolescent patients, both with and without special health care needs, are not receiving guidance from their physicians about transitioning to adult care, according to recent findings published in Pediatrics.
Lydie A. Lebrun-Harris, PhD, of the Maternal and Child Health Bureau at the Health Resources and Services Administration, and her colleagues examined data from 20,708 youth aged 12-17 years with and without special health care needs obtained from the 2016 National Survey of Children’s Health. The aim was to determine the current level of transition planning to adult care from a pediatric or other health care provider (HCP).
Parents and caregivers were asked whether a doctor or HCP had spent time alone with the adolescent during the last year, had discussed the transition to adult care, and had actively helped the adolescent “gain self-care skills or understand changes in health care” when they reached the age of 18 years.
Overall, 17% of youth with special health care needs and 14% of youth without met all three transition elements.
The figures were higher for individual measures. For instance, 44% of youth with special health care needs spent time alone with an HCP within the past year, 41% discussed transition to an adult provider, and 69% reported an HCP had worked with them to understand health care changes and gain self-care skills.
Youth without special health care needs were more likely to discus the shift to adult care with HCPs than those with special needs, but special needs youth were more likely to have met the other two transition measurements (P less than .001).
Being older (aged 15-17 years) were associated with an increased prevalence of meeting the overall transition measure and the individual elements among both youth with and without special health care needs.
“Findings from this study underscore the urgent need for HCPs to work with youth independently and in collaboration with their parents and/or caregivers throughout the adolescent years to improve transition planning,” Dr. Lebrun-Harris and her colleagues wrote.
The study was supported by the Health Resources and Services Administration and the National Alliance to Advance Adolescent Health. The authors reported having no relevant conflicts of interest.
SOURCE: Lebrun-Harris LA et al. Pediatrics. 2018 Sep 17. doi: 10.1542/peds.2018-0194.
FROM PEDIATRICS
Key clinical point:
Major finding: In total, 17% of youth with special health care needs and 14% of youth without received support for the transition to adult care.
Study details: A nationally representative exploratory analysis of transition planning from pediatric to adult health care for 20,708 adolescents from the 2016 National Survey of Children’s Health.
Disclosures: The study was supported by the Health Resources and Services Administration and the National Alliance to Advance Adolescent Health. The authors reported having no relevant conflicts of interest.
Source: Lebrun-Harris LA et al. Pediatrics. 2018 Sep 17. doi: 10.1542/peds.2018-0194.
AAP guidelines emphasize gender-affirmative care
according to an American Academy of Pediatrics policy statement published in Pediatrics.
The policy statement defines the gender-affirmative care model as one that provide “developmentally appropriate care that is oriented toward understanding and appreciating the youth’s gender experience,” wrote Jason Rafferty, MD, of the department of pediatrics at Hasbro Children’s Hospital in Providence, R.I., and the department of child psychiatryf at Emma Pendleton Bradley Hospital, East Providence, R.I. Dr. Rafferty serves on the AAP Committee on Psychosocial Aspects of Child and Family Health. The AAP Committee on Adolescence, Section on Lesbian, Gay, Bisexual, and Transgender Health and Wellness also participated in writing this policy statement.
The model emphasizes four main points, according to the statement:
- Transgender and gender-diverse identities are not mental disorders.
- Variations in gender identity are “normal aspects of human diversity.”
- Gender identity “evolves as a result of the interaction between biology, development, socialization, and culture.”
- Any mental health issue “most often stems from stigma and negative experiences” rather than being “intrinsic” to the child.
In the gender-affirmative approach, a supportive, nonjudgmental partnership between you, the patient, and the patient’s family is encouraged to “facilitate exploration of complicated emotions and gender-diverse expressions while allowing questions and concerns to be raised,” Dr. Rafferty said. This contrasts with “reparative” or “conversion” treatment, which seeks to change rather than accept the patient’s gender identity.
The AAP statement also recommends accessibility of family therapy, addressing the emotional and mental health needs not only of the patient, but also the parents, caregivers, and siblings.
The policy statement provides definitions for common terminology and distinguishes between “sex” as assigned at birth, based on anatomy, and “gender identity,” described as one’s internal sense of self. It also emphasizes that gender identity is not synonymous with sexual orientation, although the two may be interrelated. “The Gender Book” website is a resource that explains these terms and concepts.
A 2015 study revealed that 25% of transgender adults avoided a necessary doctor appointment because they feared mistreatment. Creating an environment at your office where TGD patients feel safe is key. This can be done by displaying posters or having flyers about lesbian, gay, bisexual, transgender, and questioning (LGBTQ) issues and having a gender-neutral bathroom. Educate staff by having diversity training that makes them sensitive to the needs of LGBTQ youth and their families. Patient-asserted names and pronouns should be used by staff and reflected in the EHR. “Explaining and maintaining confidentiality procedures promotes openness and trust, particularly with youth who identify as LGBTQ,” according to the statement. “Maintaining a safe clinical space can provide at least one consistent, protective refuge for patients and families, allowing authentic gender expression and exploration that builds resiliency.”
Barriers to care cited in the report include fear of discrimination by providers, lack of access to physical and sexual health services, inadequate mental health resources, and lack of provider continuity. The AAP recommends that EHRs respect the gender identity of the patient. Further research into health disparities, as well as establishment of standards of care, also are needed, the author notes.
The stigma and discrimination often experienced by TGD youth lead to feelings of rejection and isolation. Prior research has shown that transgender adolescents and adults have high rates of depression, anxiety, eating disorders, self-harm, and suicide, the report noted. One retrospective study found that 56% of transgender youth reported previous suicidal ideation, compared with 20% of those who identified as cisgender, and 31% reported a prior suicide attempt, compared with 11% cisgender youth. TGD youth also experience high rates of homelessness, violence, substance abuse, and high-risk sexual behaviors, studies have shown.
The statement also addresses issues such as medical interventions for pubertal suppression, surgical affirmation, difficulties with obtaining insurance coverage because of being transgender, family acceptance, safety in schools and communities, and medical education.
No disclosures or funding sources were reported.
SOURCE: Rafferty J et al. Pediatrics. 2018;142(4):e20182162.
The AAP policy offers a more detailed overview of the health care needs of transgender and gender-diverse (TGD) youth than was previously available, with data to support these recommendations.
Future efforts should focus on expanding the definition and components of gender-affirmative care, as well as training providers to be more competent in providing this care by introducing these concepts earlier in medical training so that pediatricians feel comfortable with implementation.
The new guidelines “emphasize that care for TGD youth is a rapidly evolving field,” and that “continued support is needed for research, education, and advocacy in this arena so we can provide the best level of evidence-based care to TGD youth.”
Gayathri Chelvakumar, MD, is an attending physician in the division of adolescent medicine at Nationwide Children’s Hospital and an assistant professor of clinical pediatrics at Ohio State University, both in Columbus. She was asked to comment on the AAP guidelines.
The AAP policy offers a more detailed overview of the health care needs of transgender and gender-diverse (TGD) youth than was previously available, with data to support these recommendations.
Future efforts should focus on expanding the definition and components of gender-affirmative care, as well as training providers to be more competent in providing this care by introducing these concepts earlier in medical training so that pediatricians feel comfortable with implementation.
The new guidelines “emphasize that care for TGD youth is a rapidly evolving field,” and that “continued support is needed for research, education, and advocacy in this arena so we can provide the best level of evidence-based care to TGD youth.”
Gayathri Chelvakumar, MD, is an attending physician in the division of adolescent medicine at Nationwide Children’s Hospital and an assistant professor of clinical pediatrics at Ohio State University, both in Columbus. She was asked to comment on the AAP guidelines.
The AAP policy offers a more detailed overview of the health care needs of transgender and gender-diverse (TGD) youth than was previously available, with data to support these recommendations.
Future efforts should focus on expanding the definition and components of gender-affirmative care, as well as training providers to be more competent in providing this care by introducing these concepts earlier in medical training so that pediatricians feel comfortable with implementation.
The new guidelines “emphasize that care for TGD youth is a rapidly evolving field,” and that “continued support is needed for research, education, and advocacy in this arena so we can provide the best level of evidence-based care to TGD youth.”
Gayathri Chelvakumar, MD, is an attending physician in the division of adolescent medicine at Nationwide Children’s Hospital and an assistant professor of clinical pediatrics at Ohio State University, both in Columbus. She was asked to comment on the AAP guidelines.
according to an American Academy of Pediatrics policy statement published in Pediatrics.
The policy statement defines the gender-affirmative care model as one that provide “developmentally appropriate care that is oriented toward understanding and appreciating the youth’s gender experience,” wrote Jason Rafferty, MD, of the department of pediatrics at Hasbro Children’s Hospital in Providence, R.I., and the department of child psychiatryf at Emma Pendleton Bradley Hospital, East Providence, R.I. Dr. Rafferty serves on the AAP Committee on Psychosocial Aspects of Child and Family Health. The AAP Committee on Adolescence, Section on Lesbian, Gay, Bisexual, and Transgender Health and Wellness also participated in writing this policy statement.
The model emphasizes four main points, according to the statement:
- Transgender and gender-diverse identities are not mental disorders.
- Variations in gender identity are “normal aspects of human diversity.”
- Gender identity “evolves as a result of the interaction between biology, development, socialization, and culture.”
- Any mental health issue “most often stems from stigma and negative experiences” rather than being “intrinsic” to the child.
In the gender-affirmative approach, a supportive, nonjudgmental partnership between you, the patient, and the patient’s family is encouraged to “facilitate exploration of complicated emotions and gender-diverse expressions while allowing questions and concerns to be raised,” Dr. Rafferty said. This contrasts with “reparative” or “conversion” treatment, which seeks to change rather than accept the patient’s gender identity.
The AAP statement also recommends accessibility of family therapy, addressing the emotional and mental health needs not only of the patient, but also the parents, caregivers, and siblings.
The policy statement provides definitions for common terminology and distinguishes between “sex” as assigned at birth, based on anatomy, and “gender identity,” described as one’s internal sense of self. It also emphasizes that gender identity is not synonymous with sexual orientation, although the two may be interrelated. “The Gender Book” website is a resource that explains these terms and concepts.
A 2015 study revealed that 25% of transgender adults avoided a necessary doctor appointment because they feared mistreatment. Creating an environment at your office where TGD patients feel safe is key. This can be done by displaying posters or having flyers about lesbian, gay, bisexual, transgender, and questioning (LGBTQ) issues and having a gender-neutral bathroom. Educate staff by having diversity training that makes them sensitive to the needs of LGBTQ youth and their families. Patient-asserted names and pronouns should be used by staff and reflected in the EHR. “Explaining and maintaining confidentiality procedures promotes openness and trust, particularly with youth who identify as LGBTQ,” according to the statement. “Maintaining a safe clinical space can provide at least one consistent, protective refuge for patients and families, allowing authentic gender expression and exploration that builds resiliency.”
Barriers to care cited in the report include fear of discrimination by providers, lack of access to physical and sexual health services, inadequate mental health resources, and lack of provider continuity. The AAP recommends that EHRs respect the gender identity of the patient. Further research into health disparities, as well as establishment of standards of care, also are needed, the author notes.
The stigma and discrimination often experienced by TGD youth lead to feelings of rejection and isolation. Prior research has shown that transgender adolescents and adults have high rates of depression, anxiety, eating disorders, self-harm, and suicide, the report noted. One retrospective study found that 56% of transgender youth reported previous suicidal ideation, compared with 20% of those who identified as cisgender, and 31% reported a prior suicide attempt, compared with 11% cisgender youth. TGD youth also experience high rates of homelessness, violence, substance abuse, and high-risk sexual behaviors, studies have shown.
The statement also addresses issues such as medical interventions for pubertal suppression, surgical affirmation, difficulties with obtaining insurance coverage because of being transgender, family acceptance, safety in schools and communities, and medical education.
No disclosures or funding sources were reported.
SOURCE: Rafferty J et al. Pediatrics. 2018;142(4):e20182162.
according to an American Academy of Pediatrics policy statement published in Pediatrics.
The policy statement defines the gender-affirmative care model as one that provide “developmentally appropriate care that is oriented toward understanding and appreciating the youth’s gender experience,” wrote Jason Rafferty, MD, of the department of pediatrics at Hasbro Children’s Hospital in Providence, R.I., and the department of child psychiatryf at Emma Pendleton Bradley Hospital, East Providence, R.I. Dr. Rafferty serves on the AAP Committee on Psychosocial Aspects of Child and Family Health. The AAP Committee on Adolescence, Section on Lesbian, Gay, Bisexual, and Transgender Health and Wellness also participated in writing this policy statement.
The model emphasizes four main points, according to the statement:
- Transgender and gender-diverse identities are not mental disorders.
- Variations in gender identity are “normal aspects of human diversity.”
- Gender identity “evolves as a result of the interaction between biology, development, socialization, and culture.”
- Any mental health issue “most often stems from stigma and negative experiences” rather than being “intrinsic” to the child.
In the gender-affirmative approach, a supportive, nonjudgmental partnership between you, the patient, and the patient’s family is encouraged to “facilitate exploration of complicated emotions and gender-diverse expressions while allowing questions and concerns to be raised,” Dr. Rafferty said. This contrasts with “reparative” or “conversion” treatment, which seeks to change rather than accept the patient’s gender identity.
The AAP statement also recommends accessibility of family therapy, addressing the emotional and mental health needs not only of the patient, but also the parents, caregivers, and siblings.
The policy statement provides definitions for common terminology and distinguishes between “sex” as assigned at birth, based on anatomy, and “gender identity,” described as one’s internal sense of self. It also emphasizes that gender identity is not synonymous with sexual orientation, although the two may be interrelated. “The Gender Book” website is a resource that explains these terms and concepts.
A 2015 study revealed that 25% of transgender adults avoided a necessary doctor appointment because they feared mistreatment. Creating an environment at your office where TGD patients feel safe is key. This can be done by displaying posters or having flyers about lesbian, gay, bisexual, transgender, and questioning (LGBTQ) issues and having a gender-neutral bathroom. Educate staff by having diversity training that makes them sensitive to the needs of LGBTQ youth and their families. Patient-asserted names and pronouns should be used by staff and reflected in the EHR. “Explaining and maintaining confidentiality procedures promotes openness and trust, particularly with youth who identify as LGBTQ,” according to the statement. “Maintaining a safe clinical space can provide at least one consistent, protective refuge for patients and families, allowing authentic gender expression and exploration that builds resiliency.”
Barriers to care cited in the report include fear of discrimination by providers, lack of access to physical and sexual health services, inadequate mental health resources, and lack of provider continuity. The AAP recommends that EHRs respect the gender identity of the patient. Further research into health disparities, as well as establishment of standards of care, also are needed, the author notes.
The stigma and discrimination often experienced by TGD youth lead to feelings of rejection and isolation. Prior research has shown that transgender adolescents and adults have high rates of depression, anxiety, eating disorders, self-harm, and suicide, the report noted. One retrospective study found that 56% of transgender youth reported previous suicidal ideation, compared with 20% of those who identified as cisgender, and 31% reported a prior suicide attempt, compared with 11% cisgender youth. TGD youth also experience high rates of homelessness, violence, substance abuse, and high-risk sexual behaviors, studies have shown.
The statement also addresses issues such as medical interventions for pubertal suppression, surgical affirmation, difficulties with obtaining insurance coverage because of being transgender, family acceptance, safety in schools and communities, and medical education.
No disclosures or funding sources were reported.
SOURCE: Rafferty J et al. Pediatrics. 2018;142(4):e20182162.
FROM PEDATRICS
Pantothenic acid enhances doxycycline’s antiacne effects
PARIS – in a randomized, double-blind, placebo-controlled trial, Maria A. Santos, MD, reported at the annual congress of the European Academy of Dermatology and Venereology.
The beauty of this treatment strategy is that it enables acne patients to obtain the therapeutic benefits of oral antibiotic therapy while minimizing exposure in accord with the current push to curb the growing problem of antibiotic resistance. Indeed, adjunctive oral pantothenic acid (also known as vitamin B5) appears to offer a solution to the high rate of clinical deterioration that often follows antibiotic discontinuation, observed Dr. Santos, a dermatologist at University of Santo Tomas Hospital in Manila.
“The use of pantothenic acid as an adjunct may enhance acne therapy and possibly prolong control despite antibiotic discontinuation,” she said.
Dr. Santos reported on 40 patients aged 16-45 years with moderate to severe acne who were randomized to 2 g/day of pantothenic acid or placebo for 16 weeks on top of 6 weeks of oral doxycycline at 100 mg once daily, plus ongoing topical adapalene and benzoyl peroxide gel.
After 8 weeks – that is, 2 weeks after everyone completed 6 weeks on doxycycline – the mean reduction in noninflammatory and total lesion counts was virtually identical in the two groups. For example, there was a 57.7% decrease in total lesion count compared with baseline in the pantothenic acid group and a 55% reduction in placebo-treated controls. Thereafter, however, the response curves diverged. Backsliding occurred in the control group such that their mean reduction in total lesions was 48.4% at 14 weeks and 40.4% at 16 weeks, compared with baseline. In contrast, patients on daily pantothenic acid had a 78.7% reduction in total lesion count at 14 weeks and an 80% decrease from baseline at 16 weeks.
Similarly, at 16 weeks, the mean reduction in noninflammatory lesions was 49% in the pantothenic acid group versus 19.2% in controls, compared with 34%-36% reductions at 10 weeks, even though all patients remained on topical adapalene and benzoyl peroxide throughout.
Mean reduction in inflammatory lesions followed the same trend; however, the numeric advantage in the pantothenic acid group didn’t achieve statistical significance.
Median Dermatology Life Quality Index scores improved over the course of the study in both groups, although significantly more patients in the pantothenic acid group achieved at least a 4-point improvement over baseline, which is considered the minimum clinically important difference. Moreover, while modified Global Severity Scores and subjective self-assessment scores improved in both groups, from week 12 onwards, the improvements were significantly greater in the pantothenic acid group.
Receiving adjunctive pantothenic acid for 10 weeks was safe. Adverse events were the same in both study arms, consisting chiefly of mild erythema, scaling, dryness, and nausea during the initial weeks on doxycycline.
Pantothenic acid is a water-soluble essential nutrient. Dr. Santos said that while the precise mechanism of the benefit seen in this randomized trial isn’t known, other investigators have generated evidence suggestive of enhanced epidermal barrier function through normalization of keratinocyte proliferation and differentiation in acne patients, coupled with antioxidant and anti-inflammatory effects.
Dr. Santos reported having no financial conflicts regarding her study, conducted free of commercial support.
PARIS – in a randomized, double-blind, placebo-controlled trial, Maria A. Santos, MD, reported at the annual congress of the European Academy of Dermatology and Venereology.
The beauty of this treatment strategy is that it enables acne patients to obtain the therapeutic benefits of oral antibiotic therapy while minimizing exposure in accord with the current push to curb the growing problem of antibiotic resistance. Indeed, adjunctive oral pantothenic acid (also known as vitamin B5) appears to offer a solution to the high rate of clinical deterioration that often follows antibiotic discontinuation, observed Dr. Santos, a dermatologist at University of Santo Tomas Hospital in Manila.
“The use of pantothenic acid as an adjunct may enhance acne therapy and possibly prolong control despite antibiotic discontinuation,” she said.
Dr. Santos reported on 40 patients aged 16-45 years with moderate to severe acne who were randomized to 2 g/day of pantothenic acid or placebo for 16 weeks on top of 6 weeks of oral doxycycline at 100 mg once daily, plus ongoing topical adapalene and benzoyl peroxide gel.
After 8 weeks – that is, 2 weeks after everyone completed 6 weeks on doxycycline – the mean reduction in noninflammatory and total lesion counts was virtually identical in the two groups. For example, there was a 57.7% decrease in total lesion count compared with baseline in the pantothenic acid group and a 55% reduction in placebo-treated controls. Thereafter, however, the response curves diverged. Backsliding occurred in the control group such that their mean reduction in total lesions was 48.4% at 14 weeks and 40.4% at 16 weeks, compared with baseline. In contrast, patients on daily pantothenic acid had a 78.7% reduction in total lesion count at 14 weeks and an 80% decrease from baseline at 16 weeks.
Similarly, at 16 weeks, the mean reduction in noninflammatory lesions was 49% in the pantothenic acid group versus 19.2% in controls, compared with 34%-36% reductions at 10 weeks, even though all patients remained on topical adapalene and benzoyl peroxide throughout.
Mean reduction in inflammatory lesions followed the same trend; however, the numeric advantage in the pantothenic acid group didn’t achieve statistical significance.
Median Dermatology Life Quality Index scores improved over the course of the study in both groups, although significantly more patients in the pantothenic acid group achieved at least a 4-point improvement over baseline, which is considered the minimum clinically important difference. Moreover, while modified Global Severity Scores and subjective self-assessment scores improved in both groups, from week 12 onwards, the improvements were significantly greater in the pantothenic acid group.
Receiving adjunctive pantothenic acid for 10 weeks was safe. Adverse events were the same in both study arms, consisting chiefly of mild erythema, scaling, dryness, and nausea during the initial weeks on doxycycline.
Pantothenic acid is a water-soluble essential nutrient. Dr. Santos said that while the precise mechanism of the benefit seen in this randomized trial isn’t known, other investigators have generated evidence suggestive of enhanced epidermal barrier function through normalization of keratinocyte proliferation and differentiation in acne patients, coupled with antioxidant and anti-inflammatory effects.
Dr. Santos reported having no financial conflicts regarding her study, conducted free of commercial support.
PARIS – in a randomized, double-blind, placebo-controlled trial, Maria A. Santos, MD, reported at the annual congress of the European Academy of Dermatology and Venereology.
The beauty of this treatment strategy is that it enables acne patients to obtain the therapeutic benefits of oral antibiotic therapy while minimizing exposure in accord with the current push to curb the growing problem of antibiotic resistance. Indeed, adjunctive oral pantothenic acid (also known as vitamin B5) appears to offer a solution to the high rate of clinical deterioration that often follows antibiotic discontinuation, observed Dr. Santos, a dermatologist at University of Santo Tomas Hospital in Manila.
“The use of pantothenic acid as an adjunct may enhance acne therapy and possibly prolong control despite antibiotic discontinuation,” she said.
Dr. Santos reported on 40 patients aged 16-45 years with moderate to severe acne who were randomized to 2 g/day of pantothenic acid or placebo for 16 weeks on top of 6 weeks of oral doxycycline at 100 mg once daily, plus ongoing topical adapalene and benzoyl peroxide gel.
After 8 weeks – that is, 2 weeks after everyone completed 6 weeks on doxycycline – the mean reduction in noninflammatory and total lesion counts was virtually identical in the two groups. For example, there was a 57.7% decrease in total lesion count compared with baseline in the pantothenic acid group and a 55% reduction in placebo-treated controls. Thereafter, however, the response curves diverged. Backsliding occurred in the control group such that their mean reduction in total lesions was 48.4% at 14 weeks and 40.4% at 16 weeks, compared with baseline. In contrast, patients on daily pantothenic acid had a 78.7% reduction in total lesion count at 14 weeks and an 80% decrease from baseline at 16 weeks.
Similarly, at 16 weeks, the mean reduction in noninflammatory lesions was 49% in the pantothenic acid group versus 19.2% in controls, compared with 34%-36% reductions at 10 weeks, even though all patients remained on topical adapalene and benzoyl peroxide throughout.
Mean reduction in inflammatory lesions followed the same trend; however, the numeric advantage in the pantothenic acid group didn’t achieve statistical significance.
Median Dermatology Life Quality Index scores improved over the course of the study in both groups, although significantly more patients in the pantothenic acid group achieved at least a 4-point improvement over baseline, which is considered the minimum clinically important difference. Moreover, while modified Global Severity Scores and subjective self-assessment scores improved in both groups, from week 12 onwards, the improvements were significantly greater in the pantothenic acid group.
Receiving adjunctive pantothenic acid for 10 weeks was safe. Adverse events were the same in both study arms, consisting chiefly of mild erythema, scaling, dryness, and nausea during the initial weeks on doxycycline.
Pantothenic acid is a water-soluble essential nutrient. Dr. Santos said that while the precise mechanism of the benefit seen in this randomized trial isn’t known, other investigators have generated evidence suggestive of enhanced epidermal barrier function through normalization of keratinocyte proliferation and differentiation in acne patients, coupled with antioxidant and anti-inflammatory effects.
Dr. Santos reported having no financial conflicts regarding her study, conducted free of commercial support.
REPORTING FROM THE EADV CONGRESS
Key clinical point: Oral pantothenic acid at 2 g/day appears to be a safe and effective adjunct to oral doxycycline for moderate to severe acne.
Major finding: Acne patients on oral pantothenic acid had a mean 80% reduction in total lesion count 10 weeks after completing 6 weeks on oral doxycycline, a rate twice that of placebo-treated controls.
Study details: This 16-week, prospective, randomized, double-blind, placebo-controlled study included 40 patients with moderate to severe acne.
Disclosures: Dr. Santos reported having no financial conflicts regarding her study, conducted free of commercial support.
Subcutaneous Actemra approved for systemic JIA
The Food and Drug Administration has approved the subcutaneous formulation of Actemra (tocilizumab) for systemic juvenile idiopathic arthritis (SJIA) for patients aged 2 years and older, according to a press release from its developer, Genentech. The intravenous formulation was approved in 2011 for this indication.
The approval is based on data the JIGSAW-118 study. This 52-week, open-label, multicenter, phase 1b pharmacokinetic/pharmacodynamic bridging study was designed to determine the appropriate dosing regimen by treating 51 patients with SJIA according to body weight.
The safety profile of subcutaneous tocilizumab was similar to that seen with intravenous tocilizumab, although there were more injection-site reactions seen with the subcutaneous formulation. Its efficacy was extrapolated based on the drug’s pharmacokinetic profile seen with IV tocilizumab in SJIA patients and with subcutaneous tocilizumab in patients with rheumatoid arthritis.
SJIA is a rare disease with limited treatment options, according to the press release. In general, JIA affects almost 300,000 children in the United States, and about 10% of those cases are SJIA.
The Food and Drug Administration has approved the subcutaneous formulation of Actemra (tocilizumab) for systemic juvenile idiopathic arthritis (SJIA) for patients aged 2 years and older, according to a press release from its developer, Genentech. The intravenous formulation was approved in 2011 for this indication.
The approval is based on data the JIGSAW-118 study. This 52-week, open-label, multicenter, phase 1b pharmacokinetic/pharmacodynamic bridging study was designed to determine the appropriate dosing regimen by treating 51 patients with SJIA according to body weight.
The safety profile of subcutaneous tocilizumab was similar to that seen with intravenous tocilizumab, although there were more injection-site reactions seen with the subcutaneous formulation. Its efficacy was extrapolated based on the drug’s pharmacokinetic profile seen with IV tocilizumab in SJIA patients and with subcutaneous tocilizumab in patients with rheumatoid arthritis.
SJIA is a rare disease with limited treatment options, according to the press release. In general, JIA affects almost 300,000 children in the United States, and about 10% of those cases are SJIA.
The Food and Drug Administration has approved the subcutaneous formulation of Actemra (tocilizumab) for systemic juvenile idiopathic arthritis (SJIA) for patients aged 2 years and older, according to a press release from its developer, Genentech. The intravenous formulation was approved in 2011 for this indication.
The approval is based on data the JIGSAW-118 study. This 52-week, open-label, multicenter, phase 1b pharmacokinetic/pharmacodynamic bridging study was designed to determine the appropriate dosing regimen by treating 51 patients with SJIA according to body weight.
The safety profile of subcutaneous tocilizumab was similar to that seen with intravenous tocilizumab, although there were more injection-site reactions seen with the subcutaneous formulation. Its efficacy was extrapolated based on the drug’s pharmacokinetic profile seen with IV tocilizumab in SJIA patients and with subcutaneous tocilizumab in patients with rheumatoid arthritis.
SJIA is a rare disease with limited treatment options, according to the press release. In general, JIA affects almost 300,000 children in the United States, and about 10% of those cases are SJIA.