Fluoxetine appeared to lower scores for obsessive-compulsive behaviors among a group of children with autism spectrum disorders (ASDs), but the positive finding fell apart during multiple secondary analyses, Dinah S. Reddihough, MD, and colleagues have reported.

At 16 weeks, children and adolescents randomized to receive the SSRI had about a 2-point improvement on the Children’s Yale-Brown Obsessive Compulsive Scale, modified for pervasive developmental disorder (CYBOCS-PDD), compared with those taking placebo. But the finding lost significance in a multivariate analysis that accounted for a between-group difference in baseline scores – an uncontrollable variable that occurred during randomization, wrote Dr. Reddihough, of the Royal Children’s Hospital in Victoria, Australia, and coauthors.

“Moreover, repeating the analyses with multiple imputation to handle the missing data, arguably a preferable analysis, also failed to show evidence of benefit of fluoxetine compared with placebo irrespective of adjustment for the baseline imbalance,” the team noted. The study was published in JAMA.

Despite the null findings of the additional adjusted analyses, the authors held out hope for fluoxetine.

“Although cautious interpretation of the results from the primary analysis is warranted, all analyses of the primary outcome yielded 95% confidence intervals that extended well above the minimum clinically important difference of 2 points, indicating that fluoxetine may reduce the frequency and severity of obsessive-compulsive behaviors in children and adolescents with ASDs. Given the large amount of missing data, the study may have been underpowered to detect the minimum clinically important difference of 2 points.”

The study comprised 146 children (mean age, 11 years) recruited through three large practices in Australia. Children were randomized to fluoxetine or placebo for 16 weeks. Fluoxetine was weight-dosed and then titrated every week for the first month to a maximum of 20 mg/day.

The primary outcome was the difference between groups in the total score on the CYBOCS-PDD at 16 weeks. Secondary endpoints included changes on the Repetitive Behavior Scale–Revised, the Spence Children’s Anxiety Scale Aberrant Behavior Checklist–Community Version, the Clinical Global Impression Scale–Global Improvement and Efficacy Index, and a Disruptiveness Assessment.

Of the cohort, 85% were male, and 30% had an intellectual disability. The placebo group had higher scores on the Repetitive Behavior Scale–Revised and the Aberrant Behavior Checklist lethargy scale than did the fluoxetine groups.

There was a very high rate of nonadherence to study protocol, with 41% of those in the active group and 30% in the placebo group not completing the treatment regimen. The most often cited reasons for treatment discontinuation included parent decision to drop out (20 fluoxetine, 12 placebo), adverse events (5 fluoxetine, 4 placebo), and clinician decision (2 fluoxetine, 2 placebo).

The primary analysis found that scores on the CYBOCS-PDD were significantly lower in the fluoxetine group at 16 weeks; the fluoxetine group had decreased its score from 12.80 to 9.02, while the placebo group went from 13.13 to 10.89. This mean 2-point difference was statistically significant and, the authors wrote, met the minimum threshold for a clinically significant difference.

But the mean between-group difference decreased to a nonsignificant 1.17 points in the sensitivity analysis that controlled for sex, verbal ability, baseline CYBOCS-PDD, and imbalances found at baseline in some of the measures.

“Moreover, repeating the analyses with multiple imputation to handle the missing data, arguably a preferable analysis, also failed to show evidence of benefit of fluoxetine compared with placebo irrespective of adjustment for the baseline imbalance,” the team said.

There were no significant differences on any of the secondary measures.

Adverse events were similar in the active and placebo groups (45% and 42%, respectively). These included mood disturbances particularly irritability (9 fluoxetine, 12 placebo), gastrointestinal problems such as nausea and diarrhea (10 fluoxetine, 7 placebo), and sleep disorders (13 fluoxetine, 16 placebo). Two patients in the placebo group and none in the active group experienced suicidality.

Dr. Reddihough and coauthors cited the study’s high dropout rate as one of its limitations.

The study was supported by a federal grant from the Australian government. Dr. Reddihough had no financial disclosures.

[email protected]

SOURCE: Reddihough DS et al. JAMA. 2019;322(16):1561-9.

Fluoxetine appeared to lower scores for obsessive-compulsive behaviors among a group of children with autism spectrum disorders (ASDs), but the positive finding fell apart during multiple secondary analyses, Dinah S. Reddihough, MD, and colleagues have reported.

At 16 weeks, children and adolescents randomized to receive the SSRI had about a 2-point improvement on the Children’s Yale-Brown Obsessive Compulsive Scale, modified for pervasive developmental disorder (CYBOCS-PDD), compared with those taking placebo. But the finding lost significance in a multivariate analysis that accounted for a between-group difference in baseline scores – an uncontrollable variable that occurred during randomization, wrote Dr. Reddihough, of the Royal Children’s Hospital in Victoria, Australia, and coauthors.

“Moreover, repeating the analyses with multiple imputation to handle the missing data, arguably a preferable analysis, also failed to show evidence of benefit of fluoxetine compared with placebo irrespective of adjustment for the baseline imbalance,” the team noted. The study was published in JAMA.

Despite the null findings of the additional adjusted analyses, the authors held out hope for fluoxetine.

“Although cautious interpretation of the results from the primary analysis is warranted, all analyses of the primary outcome yielded 95% confidence intervals that extended well above the minimum clinically important difference of 2 points, indicating that fluoxetine may reduce the frequency and severity of obsessive-compulsive behaviors in children and adolescents with ASDs. Given the large amount of missing data, the study may have been underpowered to detect the minimum clinically important difference of 2 points.”

The study comprised 146 children (mean age, 11 years) recruited through three large practices in Australia. Children were randomized to fluoxetine or placebo for 16 weeks. Fluoxetine was weight-dosed and then titrated every week for the first month to a maximum of 20 mg/day.

The primary outcome was the difference between groups in the total score on the CYBOCS-PDD at 16 weeks. Secondary endpoints included changes on the Repetitive Behavior Scale–Revised, the Spence Children’s Anxiety Scale Aberrant Behavior Checklist–Community Version, the Clinical Global Impression Scale–Global Improvement and Efficacy Index, and a Disruptiveness Assessment.

Of the cohort, 85% were male, and 30% had an intellectual disability. The placebo group had higher scores on the Repetitive Behavior Scale–Revised and the Aberrant Behavior Checklist lethargy scale than did the fluoxetine groups.

There was a very high rate of nonadherence to study protocol, with 41% of those in the active group and 30% in the placebo group not completing the treatment regimen. The most often cited reasons for treatment discontinuation included parent decision to drop out (20 fluoxetine, 12 placebo), adverse events (5 fluoxetine, 4 placebo), and clinician decision (2 fluoxetine, 2 placebo).

The primary analysis found that scores on the CYBOCS-PDD were significantly lower in the fluoxetine group at 16 weeks; the fluoxetine group had decreased its score from 12.80 to 9.02, while the placebo group went from 13.13 to 10.89. This mean 2-point difference was statistically significant and, the authors wrote, met the minimum threshold for a clinically significant difference.

But the mean between-group difference decreased to a nonsignificant 1.17 points in the sensitivity analysis that controlled for sex, verbal ability, baseline CYBOCS-PDD, and imbalances found at baseline in some of the measures.

“Moreover, repeating the analyses with multiple imputation to handle the missing data, arguably a preferable analysis, also failed to show evidence of benefit of fluoxetine compared with placebo irrespective of adjustment for the baseline imbalance,” the team said.

There were no significant differences on any of the secondary measures.

Adverse events were similar in the active and placebo groups (45% and 42%, respectively). These included mood disturbances particularly irritability (9 fluoxetine, 12 placebo), gastrointestinal problems such as nausea and diarrhea (10 fluoxetine, 7 placebo), and sleep disorders (13 fluoxetine, 16 placebo). Two patients in the placebo group and none in the active group experienced suicidality.

Dr. Reddihough and coauthors cited the study’s high dropout rate as one of its limitations.

The study was supported by a federal grant from the Australian government. Dr. Reddihough had no financial disclosures.

[email protected]

SOURCE: Reddihough DS et al. JAMA. 2019;322(16):1561-9.

Fluoxetine appeared to lower scores for obsessive-compulsive behaviors among a group of children with autism spectrum disorders (ASDs), but the positive finding fell apart during multiple secondary analyses, Dinah S. Reddihough, MD, and colleagues have reported.

At 16 weeks, children and adolescents randomized to receive the SSRI had about a 2-point improvement on the Children’s Yale-Brown Obsessive Compulsive Scale, modified for pervasive developmental disorder (CYBOCS-PDD), compared with those taking placebo. But the finding lost significance in a multivariate analysis that accounted for a between-group difference in baseline scores – an uncontrollable variable that occurred during randomization, wrote Dr. Reddihough, of the Royal Children’s Hospital in Victoria, Australia, and coauthors.

“Moreover, repeating the analyses with multiple imputation to handle the missing data, arguably a preferable analysis, also failed to show evidence of benefit of fluoxetine compared with placebo irrespective of adjustment for the baseline imbalance,” the team noted. The study was published in JAMA.

Despite the null findings of the additional adjusted analyses, the authors held out hope for fluoxetine.

“Although cautious interpretation of the results from the primary analysis is warranted, all analyses of the primary outcome yielded 95% confidence intervals that extended well above the minimum clinically important difference of 2 points, indicating that fluoxetine may reduce the frequency and severity of obsessive-compulsive behaviors in children and adolescents with ASDs. Given the large amount of missing data, the study may have been underpowered to detect the minimum clinically important difference of 2 points.”

The study comprised 146 children (mean age, 11 years) recruited through three large practices in Australia. Children were randomized to fluoxetine or placebo for 16 weeks. Fluoxetine was weight-dosed and then titrated every week for the first month to a maximum of 20 mg/day.

The primary outcome was the difference between groups in the total score on the CYBOCS-PDD at 16 weeks. Secondary endpoints included changes on the Repetitive Behavior Scale–Revised, the Spence Children’s Anxiety Scale Aberrant Behavior Checklist–Community Version, the Clinical Global Impression Scale–Global Improvement and Efficacy Index, and a Disruptiveness Assessment.

Of the cohort, 85% were male, and 30% had an intellectual disability. The placebo group had higher scores on the Repetitive Behavior Scale–Revised and the Aberrant Behavior Checklist lethargy scale than did the fluoxetine groups.

There was a very high rate of nonadherence to study protocol, with 41% of those in the active group and 30% in the placebo group not completing the treatment regimen. The most often cited reasons for treatment discontinuation included parent decision to drop out (20 fluoxetine, 12 placebo), adverse events (5 fluoxetine, 4 placebo), and clinician decision (2 fluoxetine, 2 placebo).

The primary analysis found that scores on the CYBOCS-PDD were significantly lower in the fluoxetine group at 16 weeks; the fluoxetine group had decreased its score from 12.80 to 9.02, while the placebo group went from 13.13 to 10.89. This mean 2-point difference was statistically significant and, the authors wrote, met the minimum threshold for a clinically significant difference.

But the mean between-group difference decreased to a nonsignificant 1.17 points in the sensitivity analysis that controlled for sex, verbal ability, baseline CYBOCS-PDD, and imbalances found at baseline in some of the measures.

“Moreover, repeating the analyses with multiple imputation to handle the missing data, arguably a preferable analysis, also failed to show evidence of benefit of fluoxetine compared with placebo irrespective of adjustment for the baseline imbalance,” the team said.

There were no significant differences on any of the secondary measures.

Adverse events were similar in the active and placebo groups (45% and 42%, respectively). These included mood disturbances particularly irritability (9 fluoxetine, 12 placebo), gastrointestinal problems such as nausea and diarrhea (10 fluoxetine, 7 placebo), and sleep disorders (13 fluoxetine, 16 placebo). Two patients in the placebo group and none in the active group experienced suicidality.

Dr. Reddihough and coauthors cited the study’s high dropout rate as one of its limitations.

The study was supported by a federal grant from the Australian government. Dr. Reddihough had no financial disclosures.

[email protected]

SOURCE: Reddihough DS et al. JAMA. 2019;322(16):1561-9.

The Trump administration apparently plans to ensure Americans have access to health insurance in the event that the Affordable Care Act is struck down – but officials refuse to share that plan.

“The president has made clear that we will have a plan in action to make sure that Americans have access to affordable coverage” if or when courts negate the ACA, Seema Verma, administrator of the Centers for Medicare & Medicaid Services said Oct. 23 at a House Ways and Means Health Subcommittee hearing. “We do not have that today. There are many Americans today, they are not getting a subsidy. They can’t afford insurance today.”

When asked specifically about the provision to guarantee coverage for those with preexisting conditions, Ms. Verma replied that the president “has made clear that we will do everything we can to ensure that Americans with preexisting conditions maintain the protection that they have today.”

When pressed for details, Ms. Verma dodged the question, first by attempting to tell an anecdote about “a 55-year-old couple making $66,000 a year ...” before getting cut off. When the question was reiterated by Health Subcommittee Chair Diana DeGette (D-Colo.), Ms. Verma replied, “I am not going get into any specifics of a plan.”

Committee Chair Frank Pallone (D-N.J.) said it was “deceptive” that Ms. Verma would not provide any details and openly questioned whether a plan actually existed.

The hearing followed a partisan pattern.

Republican subcommittee members asked questions that allowed Ms Verma to highlight some of the actions taken by the CMS under her watch, such as lowering premiums for exchange plans, increasing the number of available plans and decreasing the number of states that had only one plan option available in the exchange, and other items that are focused on lowering the cost of health care.

“We’re trying to focus on actions that lower the cost of care for Americans,” she said. “If we do that, more people will be able to afford health care.”

Under questioning by panel Democrats, Ms. Verma took a more adversarial tone and tended to deflect rather than answer questions.

When pressed about Medicaid work requirement and the disruption in health care coverage they are causing, Ms. Verma had no answer, instead trying to talking about “community engagement requirements” before being cut off.

Ms. Verma also refused to address the coverage requirements, or lack thereof, of short-term, limited duration plans, which have been expanded under the Trump administration.

When asked whether plans could deny claims based on preexisting conditions, could implement coverage caps, charge more based on age or gender, or ignore other consumer protections in the ACA, she consistently defaulted to a comment that it “depends” on the plan and what they offer, without coming out and simply acknowledging that these plans have it within their power to ignore any and all consumer protections held within the Affordable Care Act.

“None of the actions that we have taken do anything to undermine the protections for people with preexisting conditions,” she said.

“Your testimony is not actually truthful to us today,” Rep. Ann Kuster (D-N.H.) replied.

[email protected]

The Trump administration apparently plans to ensure Americans have access to health insurance in the event that the Affordable Care Act is struck down – but officials refuse to share that plan.

“The president has made clear that we will have a plan in action to make sure that Americans have access to affordable coverage” if or when courts negate the ACA, Seema Verma, administrator of the Centers for Medicare & Medicaid Services said Oct. 23 at a House Ways and Means Health Subcommittee hearing. “We do not have that today. There are many Americans today, they are not getting a subsidy. They can’t afford insurance today.”

When asked specifically about the provision to guarantee coverage for those with preexisting conditions, Ms. Verma replied that the president “has made clear that we will do everything we can to ensure that Americans with preexisting conditions maintain the protection that they have today.”

When pressed for details, Ms. Verma dodged the question, first by attempting to tell an anecdote about “a 55-year-old couple making $66,000 a year ...” before getting cut off. When the question was reiterated by Health Subcommittee Chair Diana DeGette (D-Colo.), Ms. Verma replied, “I am not going get into any specifics of a plan.”

Committee Chair Frank Pallone (D-N.J.) said it was “deceptive” that Ms. Verma would not provide any details and openly questioned whether a plan actually existed.

The hearing followed a partisan pattern.

Republican subcommittee members asked questions that allowed Ms Verma to highlight some of the actions taken by the CMS under her watch, such as lowering premiums for exchange plans, increasing the number of available plans and decreasing the number of states that had only one plan option available in the exchange, and other items that are focused on lowering the cost of health care.

“We’re trying to focus on actions that lower the cost of care for Americans,” she said. “If we do that, more people will be able to afford health care.”

Under questioning by panel Democrats, Ms. Verma took a more adversarial tone and tended to deflect rather than answer questions.

When pressed about Medicaid work requirement and the disruption in health care coverage they are causing, Ms. Verma had no answer, instead trying to talking about “community engagement requirements” before being cut off.

Ms. Verma also refused to address the coverage requirements, or lack thereof, of short-term, limited duration plans, which have been expanded under the Trump administration.

When asked whether plans could deny claims based on preexisting conditions, could implement coverage caps, charge more based on age or gender, or ignore other consumer protections in the ACA, she consistently defaulted to a comment that it “depends” on the plan and what they offer, without coming out and simply acknowledging that these plans have it within their power to ignore any and all consumer protections held within the Affordable Care Act.

“None of the actions that we have taken do anything to undermine the protections for people with preexisting conditions,” she said.

“Your testimony is not actually truthful to us today,” Rep. Ann Kuster (D-N.H.) replied.

[email protected]

The Trump administration apparently plans to ensure Americans have access to health insurance in the event that the Affordable Care Act is struck down – but officials refuse to share that plan.

“The president has made clear that we will have a plan in action to make sure that Americans have access to affordable coverage” if or when courts negate the ACA, Seema Verma, administrator of the Centers for Medicare & Medicaid Services said Oct. 23 at a House Ways and Means Health Subcommittee hearing. “We do not have that today. There are many Americans today, they are not getting a subsidy. They can’t afford insurance today.”

When asked specifically about the provision to guarantee coverage for those with preexisting conditions, Ms. Verma replied that the president “has made clear that we will do everything we can to ensure that Americans with preexisting conditions maintain the protection that they have today.”

When pressed for details, Ms. Verma dodged the question, first by attempting to tell an anecdote about “a 55-year-old couple making $66,000 a year ...” before getting cut off. When the question was reiterated by Health Subcommittee Chair Diana DeGette (D-Colo.), Ms. Verma replied, “I am not going get into any specifics of a plan.”

Committee Chair Frank Pallone (D-N.J.) said it was “deceptive” that Ms. Verma would not provide any details and openly questioned whether a plan actually existed.

The hearing followed a partisan pattern.

Republican subcommittee members asked questions that allowed Ms Verma to highlight some of the actions taken by the CMS under her watch, such as lowering premiums for exchange plans, increasing the number of available plans and decreasing the number of states that had only one plan option available in the exchange, and other items that are focused on lowering the cost of health care.

“We’re trying to focus on actions that lower the cost of care for Americans,” she said. “If we do that, more people will be able to afford health care.”

Under questioning by panel Democrats, Ms. Verma took a more adversarial tone and tended to deflect rather than answer questions.

When pressed about Medicaid work requirement and the disruption in health care coverage they are causing, Ms. Verma had no answer, instead trying to talking about “community engagement requirements” before being cut off.

Ms. Verma also refused to address the coverage requirements, or lack thereof, of short-term, limited duration plans, which have been expanded under the Trump administration.

When asked whether plans could deny claims based on preexisting conditions, could implement coverage caps, charge more based on age or gender, or ignore other consumer protections in the ACA, she consistently defaulted to a comment that it “depends” on the plan and what they offer, without coming out and simply acknowledging that these plans have it within their power to ignore any and all consumer protections held within the Affordable Care Act.

“None of the actions that we have taken do anything to undermine the protections for people with preexisting conditions,” she said.

“Your testimony is not actually truthful to us today,” Rep. Ann Kuster (D-N.H.) replied.

[email protected]

To the Editor:

Nevus sebaceous of Jadassohn (or nevus sebaceous [NS]) is a congenital hamartomatous disorder initially described by Jadassohn¹ in 1895. Nevus sebaceous occurs in 0.3% of newborns² and is most commonly identified on the face and scalp.^3,4 Mehregan and Pinkus⁵ characterized NS as an organoid tumor containing multiple skin components with 3 life stages. The first stage—occurring during infancy—consists of immature hair follicles and sebaceous glands. The second stage—beginning at puberty—shows development of sebaceous glands, epidermal hyperplasia, and maturation of apocrine glands. The final stage involves formation of secondary benign and malignant neoplasms.

Historically, basal cell carcinoma (BCC) was thought to be the most common neoplasm arising in NS.^5-8 In 1993, Ackerman et al⁹ introduced a new definition of trichoblastoma (TB), expanding the definition to encompass previously excluded benign follicular neoplasms. Large studies conducted after this new definition was proposed suggested that syringocystadenoma papilliferum and TB develop more frequently than does BCC.^3,4,10-15 Furthermore, Cribier et al⁴ and Merrot et al¹⁵ reviewed prior cases of NS using the new definition and asserted that the majority of previously diagnosed cases of BCC were considered to be TB under the new criteria. With the advent of modern diagnostic testing, the rate of secondary benign neoplasm growth is now thought to be between 7% and 19%, with syringocystadenoma papilliferum arising in 2% to 13% of cases and TB in 1.5% to 7%.^3,4,10-14 Malignant neoplasms are observed much less frequently, with BCC arising in 0% to 1% of NS cases.

Nevus sebaceous lesions typically enlarge during puberty, while malignant neoplasms occur almost exclusively in adulthood,^4,10-12 suggesting that hormones contribute to NS stage progression. We present the case of a woman who developed BCC in a previously asymptomatic NS during pregnancy.

A 32-year-old woman who was otherwise healthy presented to our dermatology clinic with a pink-yellow verrucous plaque on the right temporal hairline extending to the preauricular area of the face. The patient had no personal or family history of skin cancer and no history of tanning bed use. She reported that the lesion had been present since birth. A diagnosis of NS was made.

Two years later, she presented with a new bleeding growth atop the previously diagnosed NS that had been present for approximately 4 months (Figure). At this visit she was pregnant (30 weeks’ gestation). Physical examination revealed a 4-mm, brown, pearly papule at the inferior margin of the previously noted pink verrucous plaque on the right temporal hairline. A biopsy was performed and histopathology displayed aggregates of basaloid cells with a high nuclear to cytoplasmic ratio, peripheral palisading, and abundant melanin, consistent with pigmented BCC. The patient was referred for Mohs micrographic surgery; the lesion was removed with clear margins. The patient had no recurrence of BCC at 36-month follow-up.

Similarly, cases of rapid growth of NS lesions during pregnancy, a state of increased testosterone production,²⁷ have been reported.²⁸ We present a case of a BCC arising in a previously asymptomatic NS during pregnancy. To our knowledge, no large studies have assessed the effect of hormone level changes during pregnancy on NS growth and secondary malignant transformation. Prior to the 1990s, prophylactic excision of NS during childhood was recommended to prevent malignant neoplasm formation.^29,30 More recently, a more conservative approach has been advocated because of a lower rate of malignant transformation than previously thought; some dermatologists recommend close monitoring as an alternative to early removal.^{4,13,14,29,31} This case report proposes that pregnancy may be a time of increased risk for malignant transformation and that NS lesions might require close monitoring during pregnancy.

To the Editor:

Nevus sebaceous of Jadassohn (or nevus sebaceous [NS]) is a congenital hamartomatous disorder initially described by Jadassohn¹ in 1895. Nevus sebaceous occurs in 0.3% of newborns² and is most commonly identified on the face and scalp.^3,4 Mehregan and Pinkus⁵ characterized NS as an organoid tumor containing multiple skin components with 3 life stages. The first stage—occurring during infancy—consists of immature hair follicles and sebaceous glands. The second stage—beginning at puberty—shows development of sebaceous glands, epidermal hyperplasia, and maturation of apocrine glands. The final stage involves formation of secondary benign and malignant neoplasms.

Historically, basal cell carcinoma (BCC) was thought to be the most common neoplasm arising in NS.^5-8 In 1993, Ackerman et al⁹ introduced a new definition of trichoblastoma (TB), expanding the definition to encompass previously excluded benign follicular neoplasms. Large studies conducted after this new definition was proposed suggested that syringocystadenoma papilliferum and TB develop more frequently than does BCC.^3,4,10-15 Furthermore, Cribier et al⁴ and Merrot et al¹⁵ reviewed prior cases of NS using the new definition and asserted that the majority of previously diagnosed cases of BCC were considered to be TB under the new criteria. With the advent of modern diagnostic testing, the rate of secondary benign neoplasm growth is now thought to be between 7% and 19%, with syringocystadenoma papilliferum arising in 2% to 13% of cases and TB in 1.5% to 7%.^3,4,10-14 Malignant neoplasms are observed much less frequently, with BCC arising in 0% to 1% of NS cases.

Nevus sebaceous lesions typically enlarge during puberty, while malignant neoplasms occur almost exclusively in adulthood,^4,10-12 suggesting that hormones contribute to NS stage progression. We present the case of a woman who developed BCC in a previously asymptomatic NS during pregnancy.

A 32-year-old woman who was otherwise healthy presented to our dermatology clinic with a pink-yellow verrucous plaque on the right temporal hairline extending to the preauricular area of the face. The patient had no personal or family history of skin cancer and no history of tanning bed use. She reported that the lesion had been present since birth. A diagnosis of NS was made.

Two years later, she presented with a new bleeding growth atop the previously diagnosed NS that had been present for approximately 4 months (Figure). At this visit she was pregnant (30 weeks’ gestation). Physical examination revealed a 4-mm, brown, pearly papule at the inferior margin of the previously noted pink verrucous plaque on the right temporal hairline. A biopsy was performed and histopathology displayed aggregates of basaloid cells with a high nuclear to cytoplasmic ratio, peripheral palisading, and abundant melanin, consistent with pigmented BCC. The patient was referred for Mohs micrographic surgery; the lesion was removed with clear margins. The patient had no recurrence of BCC at 36-month follow-up.

Similarly, cases of rapid growth of NS lesions during pregnancy, a state of increased testosterone production,²⁷ have been reported.²⁸ We present a case of a BCC arising in a previously asymptomatic NS during pregnancy. To our knowledge, no large studies have assessed the effect of hormone level changes during pregnancy on NS growth and secondary malignant transformation. Prior to the 1990s, prophylactic excision of NS during childhood was recommended to prevent malignant neoplasm formation.^29,30 More recently, a more conservative approach has been advocated because of a lower rate of malignant transformation than previously thought; some dermatologists recommend close monitoring as an alternative to early removal.^{4,13,14,29,31} This case report proposes that pregnancy may be a time of increased risk for malignant transformation and that NS lesions might require close monitoring during pregnancy.

To the Editor:

Nevus sebaceous of Jadassohn (or nevus sebaceous [NS]) is a congenital hamartomatous disorder initially described by Jadassohn¹ in 1895. Nevus sebaceous occurs in 0.3% of newborns² and is most commonly identified on the face and scalp.^3,4 Mehregan and Pinkus⁵ characterized NS as an organoid tumor containing multiple skin components with 3 life stages. The first stage—occurring during infancy—consists of immature hair follicles and sebaceous glands. The second stage—beginning at puberty—shows development of sebaceous glands, epidermal hyperplasia, and maturation of apocrine glands. The final stage involves formation of secondary benign and malignant neoplasms.

Historically, basal cell carcinoma (BCC) was thought to be the most common neoplasm arising in NS.^5-8 In 1993, Ackerman et al⁹ introduced a new definition of trichoblastoma (TB), expanding the definition to encompass previously excluded benign follicular neoplasms. Large studies conducted after this new definition was proposed suggested that syringocystadenoma papilliferum and TB develop more frequently than does BCC.^3,4,10-15 Furthermore, Cribier et al⁴ and Merrot et al¹⁵ reviewed prior cases of NS using the new definition and asserted that the majority of previously diagnosed cases of BCC were considered to be TB under the new criteria. With the advent of modern diagnostic testing, the rate of secondary benign neoplasm growth is now thought to be between 7% and 19%, with syringocystadenoma papilliferum arising in 2% to 13% of cases and TB in 1.5% to 7%.^3,4,10-14 Malignant neoplasms are observed much less frequently, with BCC arising in 0% to 1% of NS cases.

Nevus sebaceous lesions typically enlarge during puberty, while malignant neoplasms occur almost exclusively in adulthood,^4,10-12 suggesting that hormones contribute to NS stage progression. We present the case of a woman who developed BCC in a previously asymptomatic NS during pregnancy.

A 32-year-old woman who was otherwise healthy presented to our dermatology clinic with a pink-yellow verrucous plaque on the right temporal hairline extending to the preauricular area of the face. The patient had no personal or family history of skin cancer and no history of tanning bed use. She reported that the lesion had been present since birth. A diagnosis of NS was made.

Two years later, she presented with a new bleeding growth atop the previously diagnosed NS that had been present for approximately 4 months (Figure). At this visit she was pregnant (30 weeks’ gestation). Physical examination revealed a 4-mm, brown, pearly papule at the inferior margin of the previously noted pink verrucous plaque on the right temporal hairline. A biopsy was performed and histopathology displayed aggregates of basaloid cells with a high nuclear to cytoplasmic ratio, peripheral palisading, and abundant melanin, consistent with pigmented BCC. The patient was referred for Mohs micrographic surgery; the lesion was removed with clear margins. The patient had no recurrence of BCC at 36-month follow-up.

Similarly, cases of rapid growth of NS lesions during pregnancy, a state of increased testosterone production,²⁷ have been reported.²⁸ We present a case of a BCC arising in a previously asymptomatic NS during pregnancy. To our knowledge, no large studies have assessed the effect of hormone level changes during pregnancy on NS growth and secondary malignant transformation. Prior to the 1990s, prophylactic excision of NS during childhood was recommended to prevent malignant neoplasm formation.^29,30 More recently, a more conservative approach has been advocated because of a lower rate of malignant transformation than previously thought; some dermatologists recommend close monitoring as an alternative to early removal.^{4,13,14,29,31} This case report proposes that pregnancy may be a time of increased risk for malignant transformation and that NS lesions might require close monitoring during pregnancy.

The House Ways and Means Committee is the latest to pass H.R. 3, a bill aimed at driving the price of prescription drugs down.

©Mathier/thinkstockphotos.com

During an Oct. 22, 2019, markup of the bill, Republican members criticized committee leadership for abandoning bipartisan efforts to reign in drug prices in favor of a partisan bill that so far gained no support from the minority party. H.R. 3 was passed by the Ways and Means Committee on a 24-17 party line vote.

Both “Democrats and Republicans support lowering drug prices, cracking down on overpriced drugs, giving patients more power to choose affordable medicines, and removing the wrong incentives in federal health programs that reward bad actors for raising prices,” Committee Ranking Member Kevin Brady (R-Tex.) said in his opening statement. In fact, at the request of Committee Chairman Richard Neal (D-Mass.), “both parties in this committee were working together toward that important goal. At least until Speaker Nancy Pelosi (D-Calif.) trashed the bipartisan work and forced through a secretly written, deeply controversial, and highly partisan drug bill to cure political illnesses rather than real ones.”

H.R. 3, recently renamed the Elijah E. Cummings Lower Drug Costs Now Act of 2019, would give the secretary of the Department of Health & Human Services the ability to negotiate drug prices for Medicare Part D (something explicitly banned under current law), implement an excise tax on drugs that see price hikes above the rate of inflation, cap out-of-pocket expenditures annually for Medicare Part D beneficiaries at $2,000, and use an international pricing index to help bring prices for drugs sold in the United States more in line with the lower prices in foreign countries.

But panel Democrats praised the bill as a step forward in helping to lower the cost of prescription drugs.

“H.R. 3 levels the playing field for U.S. consumers who, on average, pay four times more than patients in other countries for the exact same drugs,” Chairman Neal said in a statement following the passage.

He highlighted specifically the provision that caps out-of-pocket expenses in Part D and the HHS’ negotiating power, noting that “more people will be able to afford the drugs they need that they may have previously forgone due to high costs. With more Americans taking the medicines they’re prescribed, families will be healthier, and premiums will go down.”

Republican committee members argued that these same provisions would stifle innovation and ultimately would reduce access to medicine. Most attempts at altering the provisions through amendments were met with strict party line rejection.

[email protected]

The House Ways and Means Committee is the latest to pass H.R. 3, a bill aimed at driving the price of prescription drugs down.

©Mathier/thinkstockphotos.com

During an Oct. 22, 2019, markup of the bill, Republican members criticized committee leadership for abandoning bipartisan efforts to reign in drug prices in favor of a partisan bill that so far gained no support from the minority party. H.R. 3 was passed by the Ways and Means Committee on a 24-17 party line vote.

Both “Democrats and Republicans support lowering drug prices, cracking down on overpriced drugs, giving patients more power to choose affordable medicines, and removing the wrong incentives in federal health programs that reward bad actors for raising prices,” Committee Ranking Member Kevin Brady (R-Tex.) said in his opening statement. In fact, at the request of Committee Chairman Richard Neal (D-Mass.), “both parties in this committee were working together toward that important goal. At least until Speaker Nancy Pelosi (D-Calif.) trashed the bipartisan work and forced through a secretly written, deeply controversial, and highly partisan drug bill to cure political illnesses rather than real ones.”

H.R. 3, recently renamed the Elijah E. Cummings Lower Drug Costs Now Act of 2019, would give the secretary of the Department of Health & Human Services the ability to negotiate drug prices for Medicare Part D (something explicitly banned under current law), implement an excise tax on drugs that see price hikes above the rate of inflation, cap out-of-pocket expenditures annually for Medicare Part D beneficiaries at $2,000, and use an international pricing index to help bring prices for drugs sold in the United States more in line with the lower prices in foreign countries.

But panel Democrats praised the bill as a step forward in helping to lower the cost of prescription drugs.

“H.R. 3 levels the playing field for U.S. consumers who, on average, pay four times more than patients in other countries for the exact same drugs,” Chairman Neal said in a statement following the passage.

He highlighted specifically the provision that caps out-of-pocket expenses in Part D and the HHS’ negotiating power, noting that “more people will be able to afford the drugs they need that they may have previously forgone due to high costs. With more Americans taking the medicines they’re prescribed, families will be healthier, and premiums will go down.”

Republican committee members argued that these same provisions would stifle innovation and ultimately would reduce access to medicine. Most attempts at altering the provisions through amendments were met with strict party line rejection.

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The House Ways and Means Committee is the latest to pass H.R. 3, a bill aimed at driving the price of prescription drugs down.

©Mathier/thinkstockphotos.com

During an Oct. 22, 2019, markup of the bill, Republican members criticized committee leadership for abandoning bipartisan efforts to reign in drug prices in favor of a partisan bill that so far gained no support from the minority party. H.R. 3 was passed by the Ways and Means Committee on a 24-17 party line vote.

Both “Democrats and Republicans support lowering drug prices, cracking down on overpriced drugs, giving patients more power to choose affordable medicines, and removing the wrong incentives in federal health programs that reward bad actors for raising prices,” Committee Ranking Member Kevin Brady (R-Tex.) said in his opening statement. In fact, at the request of Committee Chairman Richard Neal (D-Mass.), “both parties in this committee were working together toward that important goal. At least until Speaker Nancy Pelosi (D-Calif.) trashed the bipartisan work and forced through a secretly written, deeply controversial, and highly partisan drug bill to cure political illnesses rather than real ones.”

H.R. 3, recently renamed the Elijah E. Cummings Lower Drug Costs Now Act of 2019, would give the secretary of the Department of Health & Human Services the ability to negotiate drug prices for Medicare Part D (something explicitly banned under current law), implement an excise tax on drugs that see price hikes above the rate of inflation, cap out-of-pocket expenditures annually for Medicare Part D beneficiaries at $2,000, and use an international pricing index to help bring prices for drugs sold in the United States more in line with the lower prices in foreign countries.

But panel Democrats praised the bill as a step forward in helping to lower the cost of prescription drugs.

“H.R. 3 levels the playing field for U.S. consumers who, on average, pay four times more than patients in other countries for the exact same drugs,” Chairman Neal said in a statement following the passage.

He highlighted specifically the provision that caps out-of-pocket expenses in Part D and the HHS’ negotiating power, noting that “more people will be able to afford the drugs they need that they may have previously forgone due to high costs. With more Americans taking the medicines they’re prescribed, families will be healthier, and premiums will go down.”

Republican committee members argued that these same provisions would stifle innovation and ultimately would reduce access to medicine. Most attempts at altering the provisions through amendments were met with strict party line rejection.

[email protected]

The novel drug bremelanotide shows promise in acquired female hypoactive sexual desire disorder, according to the results of two randomized, controlled trials and a 52-week open-label extension study published online in Obstetrics & Gynecology.

Bremelanotide, which received Food and Drug Administration approval for this indication in June 2019, is an analog of the endogenous neuropeptide alpha-melanocyte-stimulating hormone.

Two separate, identically designed phase 3 studies (RECONNECT) were performed by Sheryl Kingsburg, MD, of the Cleveland Medical Center, and associates. Combined, 1,267 premenopausal women in monogamous relationships with acquired hypoactive sexual desire disorder were randomized to bremelanotide or placebo. Women in the treatment arm had significant improvement in female sexual function index–desire domain (FSFI-D) scores from baseline to week 24 (integrated studies: 0.35; P less than .001; effect size, 0.39), compared with placebo. They also experienced significant improvement in the FSFI-desire/arousal/orgasm (FSFI-DAO) domain (integrated studies: –0.33; P less than .001; effect size, 0.27).

The most common adverse events were nausea (integrated: 40% versus 1% in placebo), flushing (20% versus 0.3%), and headache (11% versus 2%). Overall, 77% in the treatment group reported a treatment-emergent adverse event, compared with 58% in the placebo group.

The open-label follow-up study was led by James Simon, MD, of George Washington University and IntimMedicine Specialists, Washington. Of the 684 participants who opted to enter the extension study, 40% completed it. In those who received bremelanotide during the randomized trial, the change in FSFI-D scores from baseline to the end of the open-label study ranged from 1.25 to 1.30, while the change in FSFI-DAO ranged from –1.4 to –1.7. In patients originally on placebo, the changes were 0.70-0.77 and –0.9, respectively.

Both groups surpassed the minimally clinically important difference for the FSFI-D score, which is considered to be 0.6.

“Patients switching from placebo experienced a higher incidence of adverse events than those continuing on bremelanotide during the open-label extension (79% versus 63%, respectively),” Dr. Simon and associates said.

The treatment is subcutaneous and can be self-administered up to about 45 minutes before a sexual event, no more than once during a 24-hour period, and no more than 8 doses per month, according to an FDA press release. The drug is contraindicated for women with cardiovascular disease or uncontrolled hypertension due to observations of transiently, slightly increased blood pressure.

The trials were funded by Palatin Technologies and AMAG Pharmaceuticals. The authors and coauthors have extensive financial relationships with pharmaceutical companies. Dr. Carson reported no financial conflicts.

SOURCE: Obstet Gynecol. 2019 Oct 8. doi: 10.1097/AOG.0000000000003500; Obstet Gynecol. 2019 Oct 8. doi: 10.1097/AOG.0000000000003514.

The novel drug bremelanotide shows promise in acquired female hypoactive sexual desire disorder, according to the results of two randomized, controlled trials and a 52-week open-label extension study published online in Obstetrics & Gynecology.

Bremelanotide, which received Food and Drug Administration approval for this indication in June 2019, is an analog of the endogenous neuropeptide alpha-melanocyte-stimulating hormone.

Two separate, identically designed phase 3 studies (RECONNECT) were performed by Sheryl Kingsburg, MD, of the Cleveland Medical Center, and associates. Combined, 1,267 premenopausal women in monogamous relationships with acquired hypoactive sexual desire disorder were randomized to bremelanotide or placebo. Women in the treatment arm had significant improvement in female sexual function index–desire domain (FSFI-D) scores from baseline to week 24 (integrated studies: 0.35; P less than .001; effect size, 0.39), compared with placebo. They also experienced significant improvement in the FSFI-desire/arousal/orgasm (FSFI-DAO) domain (integrated studies: –0.33; P less than .001; effect size, 0.27).

The most common adverse events were nausea (integrated: 40% versus 1% in placebo), flushing (20% versus 0.3%), and headache (11% versus 2%). Overall, 77% in the treatment group reported a treatment-emergent adverse event, compared with 58% in the placebo group.

The open-label follow-up study was led by James Simon, MD, of George Washington University and IntimMedicine Specialists, Washington. Of the 684 participants who opted to enter the extension study, 40% completed it. In those who received bremelanotide during the randomized trial, the change in FSFI-D scores from baseline to the end of the open-label study ranged from 1.25 to 1.30, while the change in FSFI-DAO ranged from –1.4 to –1.7. In patients originally on placebo, the changes were 0.70-0.77 and –0.9, respectively.

Both groups surpassed the minimally clinically important difference for the FSFI-D score, which is considered to be 0.6.

“Patients switching from placebo experienced a higher incidence of adverse events than those continuing on bremelanotide during the open-label extension (79% versus 63%, respectively),” Dr. Simon and associates said.

The treatment is subcutaneous and can be self-administered up to about 45 minutes before a sexual event, no more than once during a 24-hour period, and no more than 8 doses per month, according to an FDA press release. The drug is contraindicated for women with cardiovascular disease or uncontrolled hypertension due to observations of transiently, slightly increased blood pressure.

The trials were funded by Palatin Technologies and AMAG Pharmaceuticals. The authors and coauthors have extensive financial relationships with pharmaceutical companies. Dr. Carson reported no financial conflicts.

SOURCE: Obstet Gynecol. 2019 Oct 8. doi: 10.1097/AOG.0000000000003500; Obstet Gynecol. 2019 Oct 8. doi: 10.1097/AOG.0000000000003514.

The novel drug bremelanotide shows promise in acquired female hypoactive sexual desire disorder, according to the results of two randomized, controlled trials and a 52-week open-label extension study published online in Obstetrics & Gynecology.

Bremelanotide, which received Food and Drug Administration approval for this indication in June 2019, is an analog of the endogenous neuropeptide alpha-melanocyte-stimulating hormone.

Two separate, identically designed phase 3 studies (RECONNECT) were performed by Sheryl Kingsburg, MD, of the Cleveland Medical Center, and associates. Combined, 1,267 premenopausal women in monogamous relationships with acquired hypoactive sexual desire disorder were randomized to bremelanotide or placebo. Women in the treatment arm had significant improvement in female sexual function index–desire domain (FSFI-D) scores from baseline to week 24 (integrated studies: 0.35; P less than .001; effect size, 0.39), compared with placebo. They also experienced significant improvement in the FSFI-desire/arousal/orgasm (FSFI-DAO) domain (integrated studies: –0.33; P less than .001; effect size, 0.27).

The most common adverse events were nausea (integrated: 40% versus 1% in placebo), flushing (20% versus 0.3%), and headache (11% versus 2%). Overall, 77% in the treatment group reported a treatment-emergent adverse event, compared with 58% in the placebo group.

The open-label follow-up study was led by James Simon, MD, of George Washington University and IntimMedicine Specialists, Washington. Of the 684 participants who opted to enter the extension study, 40% completed it. In those who received bremelanotide during the randomized trial, the change in FSFI-D scores from baseline to the end of the open-label study ranged from 1.25 to 1.30, while the change in FSFI-DAO ranged from –1.4 to –1.7. In patients originally on placebo, the changes were 0.70-0.77 and –0.9, respectively.

Both groups surpassed the minimally clinically important difference for the FSFI-D score, which is considered to be 0.6.

“Patients switching from placebo experienced a higher incidence of adverse events than those continuing on bremelanotide during the open-label extension (79% versus 63%, respectively),” Dr. Simon and associates said.

The treatment is subcutaneous and can be self-administered up to about 45 minutes before a sexual event, no more than once during a 24-hour period, and no more than 8 doses per month, according to an FDA press release. The drug is contraindicated for women with cardiovascular disease or uncontrolled hypertension due to observations of transiently, slightly increased blood pressure.

The trials were funded by Palatin Technologies and AMAG Pharmaceuticals. The authors and coauthors have extensive financial relationships with pharmaceutical companies. Dr. Carson reported no financial conflicts.

SOURCE: Obstet Gynecol. 2019 Oct 8. doi: 10.1097/AOG.0000000000003500; Obstet Gynecol. 2019 Oct 8. doi: 10.1097/AOG.0000000000003514.

Violent deaths have been rising among young people aged 10-19 years in the United States since 2007, driven largely by increases in suicides, according to the National Center for Health Statistics.

Death rates from suicide for children aged 10-14 years jumped by 178% from 2007 to 2017, while teenagers aged 15-19 years experienced a 76% increase over that period, with both changes reaching significance, the NCHS said in a recent data brief based on data from the National Vital Statistics System.

The actual rate for teens was higher to begin with, however, so in absolute terms the increase is larger for the older group. In 2007, deaths from suicide occurred at a rate of 6.7 per 100,000 persons for persons aged 15-19 years, and by 2017 that rate was up significantly to 11.8 per 100,000. Among children aged 10-14 years, the suicide-related death rate climbed from 0.9 per 100,000 in 2007 to 2.5 in 2014, the NCHS investigators reported.

The news was somewhat better on the other side of the violent death coin. Homicides are down by a significant 18% since 2000 among children aged 10-14 years, as the rate dropped from 1.1 per 100,000 in 2000 to 0.9 in 2017. The homicide rate since 2000 is down slightly for teens aged 15-19 years, but it has risen 32% in recent years, going from 6.6 deaths per 100,000 in 2013 to 8.7 in 2017, they said.

Suicide was the second-leading cause of death in both age groups in 2017, and homicide was third for those aged 15-19 and fifth among 10- to 14-year-olds, the investigators noted.

[email protected]

Violent deaths have been rising among young people aged 10-19 years in the United States since 2007, driven largely by increases in suicides, according to the National Center for Health Statistics.

Death rates from suicide for children aged 10-14 years jumped by 178% from 2007 to 2017, while teenagers aged 15-19 years experienced a 76% increase over that period, with both changes reaching significance, the NCHS said in a recent data brief based on data from the National Vital Statistics System.

The actual rate for teens was higher to begin with, however, so in absolute terms the increase is larger for the older group. In 2007, deaths from suicide occurred at a rate of 6.7 per 100,000 persons for persons aged 15-19 years, and by 2017 that rate was up significantly to 11.8 per 100,000. Among children aged 10-14 years, the suicide-related death rate climbed from 0.9 per 100,000 in 2007 to 2.5 in 2014, the NCHS investigators reported.

The news was somewhat better on the other side of the violent death coin. Homicides are down by a significant 18% since 2000 among children aged 10-14 years, as the rate dropped from 1.1 per 100,000 in 2000 to 0.9 in 2017. The homicide rate since 2000 is down slightly for teens aged 15-19 years, but it has risen 32% in recent years, going from 6.6 deaths per 100,000 in 2013 to 8.7 in 2017, they said.

Suicide was the second-leading cause of death in both age groups in 2017, and homicide was third for those aged 15-19 and fifth among 10- to 14-year-olds, the investigators noted.

[email protected]

Violent deaths have been rising among young people aged 10-19 years in the United States since 2007, driven largely by increases in suicides, according to the National Center for Health Statistics.

Death rates from suicide for children aged 10-14 years jumped by 178% from 2007 to 2017, while teenagers aged 15-19 years experienced a 76% increase over that period, with both changes reaching significance, the NCHS said in a recent data brief based on data from the National Vital Statistics System.

The actual rate for teens was higher to begin with, however, so in absolute terms the increase is larger for the older group. In 2007, deaths from suicide occurred at a rate of 6.7 per 100,000 persons for persons aged 15-19 years, and by 2017 that rate was up significantly to 11.8 per 100,000. Among children aged 10-14 years, the suicide-related death rate climbed from 0.9 per 100,000 in 2007 to 2.5 in 2014, the NCHS investigators reported.

The news was somewhat better on the other side of the violent death coin. Homicides are down by a significant 18% since 2000 among children aged 10-14 years, as the rate dropped from 1.1 per 100,000 in 2000 to 0.9 in 2017. The homicide rate since 2000 is down slightly for teens aged 15-19 years, but it has risen 32% in recent years, going from 6.6 deaths per 100,000 in 2013 to 8.7 in 2017, they said.

Suicide was the second-leading cause of death in both age groups in 2017, and homicide was third for those aged 15-19 and fifth among 10- to 14-year-olds, the investigators noted.

[email protected]

Three international clinical trials in Europe are examining the effectiveness of treat-to-target (T2T) therapeutic regimens in patients with axial spondyloarthritis (axSpA), including two that will be the first randomized trial evidence to support or refute the T2T strategy for patients ranging from those with nonradiographic disease to patients with ankylosing spondylitis.

T2T has proved before to work in patients with rheumatoid arthritis and psoriatic arthritis with evidence from the TICORA (Tight Control of Rheumatoid Arthritis) and TICOPA (Tight Control in Psoriatic Arthritis) trials.

Two T2T trials in axSpA are still in the recruiting phase, and one has completed enrollment, with no results available yet.
 

Tight control in spondyloarthritis (TICOSPA)

TICOSPA is a 1-year, ongoing, multinational, cluster-randomized, prospective cohort study that has enrolled 163 patients with a diagnosis of active axial spondyloarthritis to evaluate the potential benefit of a T2T strategy in which the rheumatologist will agree to monitor very closely – at least every 4 weeks – and treat patients in accordance with a predefined strategy. The T2T strategy is compared with usual care as given by the treating rheumatologist. Prior to the trial, patients were on nonoptimal NSAID treatment.

“Tight control” in this study refers to the time from treatment initiation to adequate assessment of efficacy and safety, which for efficacy should be at 2-4 weeks for NSAIDs and 12-16 weeks for tumor necrosis factor inhibitors but can be a very short time frame for evaluating safety, “based on the occurrence of adverse events,” according to the study description at clinicaltrials.gov.

The primary endpoint is change on the Assessment of SpondyloArthritis international Society (ASAS) Health Index-Numerical Rating Score over the 1 year of follow-up.

There are 11 secondary endpoints, including:

• Percentage reaching major improvement in the Ankylosing Spondylitis Disease Activity Scale score (ASDAS).
• Percentage reaching 50% improvement of the initial Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) score at 1 year.
• Change in the ASAS-NSAID score over 1 year.
• Change in the Work Productivity and Activity Impairment questionnaire.

The study is being conducted at 18 centers in Belgium, France, and the Netherlands and is sponsored by the Association de Recherche Clinique en Rhumatologie.
 

AScalate: Treat-to-target in axial spondyloarthritis

The Novartis-sponsored AScalate study seeks to enroll 300 patients with active disease despite NSAID therapy. The 36-week, randomized, parallel-group, open-label, multicenter trial will be conducted at seven sites in Germany.

The study will randomize patients to either of two arms: An active group will receive T2T therapy with secukinumab as a first-line biologic in escalating doses of 150-300 mg, determined by patient response until the T2T goal had been reached. Patients who don’t respond to secukinumab will be switched to an adalimumab biosimilar. The comparator group will receive standard-of-care therapy up to the maximum recommended dose at the discretion of the investigator.

The primary endpoint is the percentage of patients in each group who meet ASAS 40 response criteria by 24 weeks.

There are 11 secondary endpoints, including:

• Percentage achieving an ASAS40 response at 12 weeks.
• Percentage achieving ASAS20 and ASAS partial response at 12 and 24 weeks.
• Proportion of patients meeting the ASDAS definition of inactive disease, ASDAS clinically important and major improvement, and ASDAS low disease activity.
• Proportion of patients achieving 50% improvement of the initial BASDAI score.

Treat-to-target with secukinumab in axial spondyloarthritis (TRACE)

TRACE is a Novartis-sponsored phase 4 study examining reductions of inflammation seen on MRI of sacroiliac joints and spine at 16-24 weeks in patients who achieve ASDAS remission (score of less than 1.3) on 150 mg secukinumab by 16 weeks. The comparator group will be patients who are not in remission by week 16 and need a dose increase to 300 mg. The Danish trial seeks 88 participants with high disease activity and MRI signs of inflammation in the sacroiliac joints and/ or the spine.

After an initial four weekly doses of secukinumab 150 mg, patients will receive monthly secukinumab 150-mg doses out to week 16. Nonresponders at week 16 will escalate to 300 mg. If by 24 weeks these patients do not respond, they will be switched to a TNF inhibitor.

The primary outcome is the proportion of patients with a positive change in MRI-inflammation as measured by the sum of the Spondyloarthritis Research Consortium of Canada (SPARCC) sacroiliac joint and spine inflammation indices.

[email protected]

Three international clinical trials in Europe are examining the effectiveness of treat-to-target (T2T) therapeutic regimens in patients with axial spondyloarthritis (axSpA), including two that will be the first randomized trial evidence to support or refute the T2T strategy for patients ranging from those with nonradiographic disease to patients with ankylosing spondylitis.

T2T has proved before to work in patients with rheumatoid arthritis and psoriatic arthritis with evidence from the TICORA (Tight Control of Rheumatoid Arthritis) and TICOPA (Tight Control in Psoriatic Arthritis) trials.

Two T2T trials in axSpA are still in the recruiting phase, and one has completed enrollment, with no results available yet.
 

Tight control in spondyloarthritis (TICOSPA)

TICOSPA is a 1-year, ongoing, multinational, cluster-randomized, prospective cohort study that has enrolled 163 patients with a diagnosis of active axial spondyloarthritis to evaluate the potential benefit of a T2T strategy in which the rheumatologist will agree to monitor very closely – at least every 4 weeks – and treat patients in accordance with a predefined strategy. The T2T strategy is compared with usual care as given by the treating rheumatologist. Prior to the trial, patients were on nonoptimal NSAID treatment.

“Tight control” in this study refers to the time from treatment initiation to adequate assessment of efficacy and safety, which for efficacy should be at 2-4 weeks for NSAIDs and 12-16 weeks for tumor necrosis factor inhibitors but can be a very short time frame for evaluating safety, “based on the occurrence of adverse events,” according to the study description at clinicaltrials.gov.

The primary endpoint is change on the Assessment of SpondyloArthritis international Society (ASAS) Health Index-Numerical Rating Score over the 1 year of follow-up.

There are 11 secondary endpoints, including:

• Percentage reaching major improvement in the Ankylosing Spondylitis Disease Activity Scale score (ASDAS).
• Percentage reaching 50% improvement of the initial Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) score at 1 year.
• Change in the ASAS-NSAID score over 1 year.
• Change in the Work Productivity and Activity Impairment questionnaire.

The study is being conducted at 18 centers in Belgium, France, and the Netherlands and is sponsored by the Association de Recherche Clinique en Rhumatologie.
 

AScalate: Treat-to-target in axial spondyloarthritis

The Novartis-sponsored AScalate study seeks to enroll 300 patients with active disease despite NSAID therapy. The 36-week, randomized, parallel-group, open-label, multicenter trial will be conducted at seven sites in Germany.

The study will randomize patients to either of two arms: An active group will receive T2T therapy with secukinumab as a first-line biologic in escalating doses of 150-300 mg, determined by patient response until the T2T goal had been reached. Patients who don’t respond to secukinumab will be switched to an adalimumab biosimilar. The comparator group will receive standard-of-care therapy up to the maximum recommended dose at the discretion of the investigator.

The primary endpoint is the percentage of patients in each group who meet ASAS 40 response criteria by 24 weeks.

There are 11 secondary endpoints, including:

• Percentage achieving an ASAS40 response at 12 weeks.
• Percentage achieving ASAS20 and ASAS partial response at 12 and 24 weeks.
• Proportion of patients meeting the ASDAS definition of inactive disease, ASDAS clinically important and major improvement, and ASDAS low disease activity.
• Proportion of patients achieving 50% improvement of the initial BASDAI score.

Treat-to-target with secukinumab in axial spondyloarthritis (TRACE)

TRACE is a Novartis-sponsored phase 4 study examining reductions of inflammation seen on MRI of sacroiliac joints and spine at 16-24 weeks in patients who achieve ASDAS remission (score of less than 1.3) on 150 mg secukinumab by 16 weeks. The comparator group will be patients who are not in remission by week 16 and need a dose increase to 300 mg. The Danish trial seeks 88 participants with high disease activity and MRI signs of inflammation in the sacroiliac joints and/ or the spine.

After an initial four weekly doses of secukinumab 150 mg, patients will receive monthly secukinumab 150-mg doses out to week 16. Nonresponders at week 16 will escalate to 300 mg. If by 24 weeks these patients do not respond, they will be switched to a TNF inhibitor.

The primary outcome is the proportion of patients with a positive change in MRI-inflammation as measured by the sum of the Spondyloarthritis Research Consortium of Canada (SPARCC) sacroiliac joint and spine inflammation indices.

[email protected]

Three international clinical trials in Europe are examining the effectiveness of treat-to-target (T2T) therapeutic regimens in patients with axial spondyloarthritis (axSpA), including two that will be the first randomized trial evidence to support or refute the T2T strategy for patients ranging from those with nonradiographic disease to patients with ankylosing spondylitis.

T2T has proved before to work in patients with rheumatoid arthritis and psoriatic arthritis with evidence from the TICORA (Tight Control of Rheumatoid Arthritis) and TICOPA (Tight Control in Psoriatic Arthritis) trials.

Two T2T trials in axSpA are still in the recruiting phase, and one has completed enrollment, with no results available yet.
 

Tight control in spondyloarthritis (TICOSPA)

TICOSPA is a 1-year, ongoing, multinational, cluster-randomized, prospective cohort study that has enrolled 163 patients with a diagnosis of active axial spondyloarthritis to evaluate the potential benefit of a T2T strategy in which the rheumatologist will agree to monitor very closely – at least every 4 weeks – and treat patients in accordance with a predefined strategy. The T2T strategy is compared with usual care as given by the treating rheumatologist. Prior to the trial, patients were on nonoptimal NSAID treatment.

“Tight control” in this study refers to the time from treatment initiation to adequate assessment of efficacy and safety, which for efficacy should be at 2-4 weeks for NSAIDs and 12-16 weeks for tumor necrosis factor inhibitors but can be a very short time frame for evaluating safety, “based on the occurrence of adverse events,” according to the study description at clinicaltrials.gov.

The primary endpoint is change on the Assessment of SpondyloArthritis international Society (ASAS) Health Index-Numerical Rating Score over the 1 year of follow-up.

There are 11 secondary endpoints, including:

• Percentage reaching major improvement in the Ankylosing Spondylitis Disease Activity Scale score (ASDAS).
• Percentage reaching 50% improvement of the initial Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) score at 1 year.
• Change in the ASAS-NSAID score over 1 year.
• Change in the Work Productivity and Activity Impairment questionnaire.

The study is being conducted at 18 centers in Belgium, France, and the Netherlands and is sponsored by the Association de Recherche Clinique en Rhumatologie.
 

AScalate: Treat-to-target in axial spondyloarthritis

The Novartis-sponsored AScalate study seeks to enroll 300 patients with active disease despite NSAID therapy. The 36-week, randomized, parallel-group, open-label, multicenter trial will be conducted at seven sites in Germany.

The study will randomize patients to either of two arms: An active group will receive T2T therapy with secukinumab as a first-line biologic in escalating doses of 150-300 mg, determined by patient response until the T2T goal had been reached. Patients who don’t respond to secukinumab will be switched to an adalimumab biosimilar. The comparator group will receive standard-of-care therapy up to the maximum recommended dose at the discretion of the investigator.

The primary endpoint is the percentage of patients in each group who meet ASAS 40 response criteria by 24 weeks.

There are 11 secondary endpoints, including:

• Percentage achieving an ASAS40 response at 12 weeks.
• Percentage achieving ASAS20 and ASAS partial response at 12 and 24 weeks.
• Proportion of patients meeting the ASDAS definition of inactive disease, ASDAS clinically important and major improvement, and ASDAS low disease activity.
• Proportion of patients achieving 50% improvement of the initial BASDAI score.

Treat-to-target with secukinumab in axial spondyloarthritis (TRACE)

TRACE is a Novartis-sponsored phase 4 study examining reductions of inflammation seen on MRI of sacroiliac joints and spine at 16-24 weeks in patients who achieve ASDAS remission (score of less than 1.3) on 150 mg secukinumab by 16 weeks. The comparator group will be patients who are not in remission by week 16 and need a dose increase to 300 mg. The Danish trial seeks 88 participants with high disease activity and MRI signs of inflammation in the sacroiliac joints and/ or the spine.

After an initial four weekly doses of secukinumab 150 mg, patients will receive monthly secukinumab 150-mg doses out to week 16. Nonresponders at week 16 will escalate to 300 mg. If by 24 weeks these patients do not respond, they will be switched to a TNF inhibitor.

The primary outcome is the proportion of patients with a positive change in MRI-inflammation as measured by the sum of the Spondyloarthritis Research Consortium of Canada (SPARCC) sacroiliac joint and spine inflammation indices.

[email protected]

“Why didn’t you see that patient?”

TongRo Images/Thinkstock

The hospitalist on the phone was angry. He’d wanted the patient seen by neurology and cleared for discharge. Apparently, I hadn’t complied.

Actually, that isn’t true. I was on call, so I had dutifully dragged myself in (with the help of some coffee), reviewed the chart, and gone in to see the fellow.

The patient, however, had other ideas. He said he was sick of doctors, didn’t like them, didn’t want to see me, and asked me to leave. So I did.

This threw off the hospitalist’s well-choreographed day of admissions and discharges. Without me seeing the patient, he had to either discharge him on his own decision or find another neurologist who would do it.

Sorry, but I’m not going to force this issue. If a patient doesn’t want to see me, it’s not worth fighting over. Believe me, I get paid to see patients, so I don’t have much incentive to just walk away.

But at the same time I have to respect patients’ decisions. While a neurology consult is pretty noninvasive, it’s still a part of medicine. If a patient doesn’t want to see me, I’m not going to force them to.

Granted, there are exceptions. Obviously, if the patient is fairly demented or otherwise not mentally competent to make such a decision, I’ll see them. In those cases, their deteriorating mental status is likely the reason for the consult.

But the fellow that day seemed alert and reasonable, and there was nothing in the chart about confusion. So I’m going to assume he knew what he was doing when he told me to go away.

The hospitalist didn’t see this as an issue, but I did. Doing a consult on a patient who doesn’t want one seems, at least to me, like harassment. I’m sorry if it messes up the discharge planning, but that’s not my fault. It’s the patient’s decision.

While I may disagree at times with patients’ decisions, their autonomy is still central to medicine. I respect and believe in that, even if it makes things more difficult for those around them.

Dr. Block has a solo neurology practice in Scottsdale, Ariz.

“Why didn’t you see that patient?”

TongRo Images/Thinkstock

The hospitalist on the phone was angry. He’d wanted the patient seen by neurology and cleared for discharge. Apparently, I hadn’t complied.

Actually, that isn’t true. I was on call, so I had dutifully dragged myself in (with the help of some coffee), reviewed the chart, and gone in to see the fellow.

The patient, however, had other ideas. He said he was sick of doctors, didn’t like them, didn’t want to see me, and asked me to leave. So I did.

This threw off the hospitalist’s well-choreographed day of admissions and discharges. Without me seeing the patient, he had to either discharge him on his own decision or find another neurologist who would do it.

Sorry, but I’m not going to force this issue. If a patient doesn’t want to see me, it’s not worth fighting over. Believe me, I get paid to see patients, so I don’t have much incentive to just walk away.

But at the same time I have to respect patients’ decisions. While a neurology consult is pretty noninvasive, it’s still a part of medicine. If a patient doesn’t want to see me, I’m not going to force them to.

Granted, there are exceptions. Obviously, if the patient is fairly demented or otherwise not mentally competent to make such a decision, I’ll see them. In those cases, their deteriorating mental status is likely the reason for the consult.

But the fellow that day seemed alert and reasonable, and there was nothing in the chart about confusion. So I’m going to assume he knew what he was doing when he told me to go away.

The hospitalist didn’t see this as an issue, but I did. Doing a consult on a patient who doesn’t want one seems, at least to me, like harassment. I’m sorry if it messes up the discharge planning, but that’s not my fault. It’s the patient’s decision.

While I may disagree at times with patients’ decisions, their autonomy is still central to medicine. I respect and believe in that, even if it makes things more difficult for those around them.

Dr. Block has a solo neurology practice in Scottsdale, Ariz.

“Why didn’t you see that patient?”

TongRo Images/Thinkstock

The hospitalist on the phone was angry. He’d wanted the patient seen by neurology and cleared for discharge. Apparently, I hadn’t complied.

Actually, that isn’t true. I was on call, so I had dutifully dragged myself in (with the help of some coffee), reviewed the chart, and gone in to see the fellow.

The patient, however, had other ideas. He said he was sick of doctors, didn’t like them, didn’t want to see me, and asked me to leave. So I did.

This threw off the hospitalist’s well-choreographed day of admissions and discharges. Without me seeing the patient, he had to either discharge him on his own decision or find another neurologist who would do it.

Sorry, but I’m not going to force this issue. If a patient doesn’t want to see me, it’s not worth fighting over. Believe me, I get paid to see patients, so I don’t have much incentive to just walk away.

But at the same time I have to respect patients’ decisions. While a neurology consult is pretty noninvasive, it’s still a part of medicine. If a patient doesn’t want to see me, I’m not going to force them to.

Granted, there are exceptions. Obviously, if the patient is fairly demented or otherwise not mentally competent to make such a decision, I’ll see them. In those cases, their deteriorating mental status is likely the reason for the consult.

But the fellow that day seemed alert and reasonable, and there was nothing in the chart about confusion. So I’m going to assume he knew what he was doing when he told me to go away.

The hospitalist didn’t see this as an issue, but I did. Doing a consult on a patient who doesn’t want one seems, at least to me, like harassment. I’m sorry if it messes up the discharge planning, but that’s not my fault. It’s the patient’s decision.

While I may disagree at times with patients’ decisions, their autonomy is still central to medicine. I respect and believe in that, even if it makes things more difficult for those around them.

Dr. Block has a solo neurology practice in Scottsdale, Ariz.

Let’s suppose your first patient of the morning is a 2-month-old you have never seen before. The family arrives 10 minutes late because they are still getting the dressing-undressing-diaper change-car seat–adjusting thing worked out. Father is a computer programmer. Mother lists her occupation as nutrition counselor. The child is gaining. Breastfeeding seems to come naturally to the dyad.

KatarzynaBialasiewicz/Thinkstock

As the visit draws to a close, you take the matter-of-fact approach and say, “The nurse will be in shortly with the vaccines do you have any questions.” Well ... it turns out the parents don’t feel comfortable with vaccines. They claim to understand the science and feel that vaccines make sense for some families. But they feel that for themselves, with a healthy lifestyle and God’s benevolence their son will be protected without having to introduce a host of foreign substances into his body.

What word best describes your reaction? Anger? Frustration? Disappointment (in our education system)? Maybe you’re angry at yourself for failing to make it clear in your office pamphlet and social media feeds that to protect your other patients, you no longer accept families who refuse immunizations for the common childhood diseases.

The American Academy of Pediatrics says it feels your pain, and its Annual Leadership Forum made eliminating nonmedical vaccine exemption laws its top priority in 2019. As part of its effort to help, the AAP Board of Directors was asked to advocate for the creation of a toolkit of strategies for Academy chapters facing the challenge of nonmedical exemptions. As an initial step to this process, three physicians in the department of pediatrics at the Denver Health Medical Center have begun interviewing religious leaders in hopes of developing “clergy-specific vaccine educational materials and deriv[ing] best practices for engaging them as vaccination advocates.” The investigators describe their plan and initial findings in Pediatrics (2019 Oct. doi: 10.1542/peds.2019-0933). Although they acknowledged that their efforts may not provide a quick solution to the nonmedical exemption problem, they hope that including more stakeholders and engendering trust will help future discussions.

Fourteen pages deeper into that issue of Pediatrics is the runner-up submission of this year’s Section on Pediatric Trainees essay competition titled “What I Learned From the Antivaccine Movement” (2019 Oct. doi: 10.1542/peds.2019-2384). Alana C. Ju, MD, describes the 2-hour ordeal she endured to testify at the California State Capitol in support of a state Senate bill aimed at tightening the regulations for vaccine medical exemptions. Totally unprepared for the “level of vitriol” aimed at her and other supporters of the bill, she was “accused of violating her duty as” a pediatrician because she was failing to protect children. The supporters were called “greedy, ignorant, and negligent.”

To her credit, Dr. Ju was able to step back from this assault and began looking at the faces of her accusers and learned that, “they too, felt strongly about children’s health.” She realized that “focusing on perceived ignorance is counterproductive.” She now hopes that by focusing on the shared goal of what is best for children, “we can all be better advocates.”

Both of these articles have a warm sort of kumbaya feel about them. It never is a bad idea to learn more about those with whom we disagree. But before huddling up too close to the campfire, we must realize that there is good evidence that sharing the scientific data with vaccine-hesitant parents doesn’t convert them into vaccine acceptors. In fact, it may strengthen their resolve to resist (Nyhan et al. “Effective Messages in Vaccine Promotion: A Randomized Trial,” Pediatrics. 2014 Apr;133[4] e835-42).

We are unlikely to convert many anti-vaxxers by sitting down together. Our target audience needs to be legislators and the majority of people who do vaccinate their children. These are the voters who will support legislation to eliminate nonmedical vaccine exemptions. To characterize anti-vaxxers as despicable ignorants is untrue and serves no purpose. We all do care about the health of children. However, the evidence is clear that nonmedical exemptions are threatening the population at large and need to be curtailed.

Dr. Wilkoff practiced primary care pediatrics in Brunswick, Maine, for nearly 40 years. He has authored several books on behavioral pediatrics, including “How to Say No to Your Toddler.” Email him at [email protected].

*This article has been updated 1/22/2020.

Let’s suppose your first patient of the morning is a 2-month-old you have never seen before. The family arrives 10 minutes late because they are still getting the dressing-undressing-diaper change-car seat–adjusting thing worked out. Father is a computer programmer. Mother lists her occupation as nutrition counselor. The child is gaining. Breastfeeding seems to come naturally to the dyad.

KatarzynaBialasiewicz/Thinkstock

As the visit draws to a close, you take the matter-of-fact approach and say, “The nurse will be in shortly with the vaccines do you have any questions.” Well ... it turns out the parents don’t feel comfortable with vaccines. They claim to understand the science and feel that vaccines make sense for some families. But they feel that for themselves, with a healthy lifestyle and God’s benevolence their son will be protected without having to introduce a host of foreign substances into his body.

What word best describes your reaction? Anger? Frustration? Disappointment (in our education system)? Maybe you’re angry at yourself for failing to make it clear in your office pamphlet and social media feeds that to protect your other patients, you no longer accept families who refuse immunizations for the common childhood diseases.

The American Academy of Pediatrics says it feels your pain, and its Annual Leadership Forum made eliminating nonmedical vaccine exemption laws its top priority in 2019. As part of its effort to help, the AAP Board of Directors was asked to advocate for the creation of a toolkit of strategies for Academy chapters facing the challenge of nonmedical exemptions. As an initial step to this process, three physicians in the department of pediatrics at the Denver Health Medical Center have begun interviewing religious leaders in hopes of developing “clergy-specific vaccine educational materials and deriv[ing] best practices for engaging them as vaccination advocates.” The investigators describe their plan and initial findings in Pediatrics (2019 Oct. doi: 10.1542/peds.2019-0933). Although they acknowledged that their efforts may not provide a quick solution to the nonmedical exemption problem, they hope that including more stakeholders and engendering trust will help future discussions.

Fourteen pages deeper into that issue of Pediatrics is the runner-up submission of this year’s Section on Pediatric Trainees essay competition titled “What I Learned From the Antivaccine Movement” (2019 Oct. doi: 10.1542/peds.2019-2384). Alana C. Ju, MD, describes the 2-hour ordeal she endured to testify at the California State Capitol in support of a state Senate bill aimed at tightening the regulations for vaccine medical exemptions. Totally unprepared for the “level of vitriol” aimed at her and other supporters of the bill, she was “accused of violating her duty as” a pediatrician because she was failing to protect children. The supporters were called “greedy, ignorant, and negligent.”

To her credit, Dr. Ju was able to step back from this assault and began looking at the faces of her accusers and learned that, “they too, felt strongly about children’s health.” She realized that “focusing on perceived ignorance is counterproductive.” She now hopes that by focusing on the shared goal of what is best for children, “we can all be better advocates.”

Both of these articles have a warm sort of kumbaya feel about them. It never is a bad idea to learn more about those with whom we disagree. But before huddling up too close to the campfire, we must realize that there is good evidence that sharing the scientific data with vaccine-hesitant parents doesn’t convert them into vaccine acceptors. In fact, it may strengthen their resolve to resist (Nyhan et al. “Effective Messages in Vaccine Promotion: A Randomized Trial,” Pediatrics. 2014 Apr;133[4] e835-42).

We are unlikely to convert many anti-vaxxers by sitting down together. Our target audience needs to be legislators and the majority of people who do vaccinate their children. These are the voters who will support legislation to eliminate nonmedical vaccine exemptions. To characterize anti-vaxxers as despicable ignorants is untrue and serves no purpose. We all do care about the health of children. However, the evidence is clear that nonmedical exemptions are threatening the population at large and need to be curtailed.

Dr. Wilkoff practiced primary care pediatrics in Brunswick, Maine, for nearly 40 years. He has authored several books on behavioral pediatrics, including “How to Say No to Your Toddler.” Email him at [email protected].

*This article has been updated 1/22/2020.

Let’s suppose your first patient of the morning is a 2-month-old you have never seen before. The family arrives 10 minutes late because they are still getting the dressing-undressing-diaper change-car seat–adjusting thing worked out. Father is a computer programmer. Mother lists her occupation as nutrition counselor. The child is gaining. Breastfeeding seems to come naturally to the dyad.

KatarzynaBialasiewicz/Thinkstock

As the visit draws to a close, you take the matter-of-fact approach and say, “The nurse will be in shortly with the vaccines do you have any questions.” Well ... it turns out the parents don’t feel comfortable with vaccines. They claim to understand the science and feel that vaccines make sense for some families. But they feel that for themselves, with a healthy lifestyle and God’s benevolence their son will be protected without having to introduce a host of foreign substances into his body.

What word best describes your reaction? Anger? Frustration? Disappointment (in our education system)? Maybe you’re angry at yourself for failing to make it clear in your office pamphlet and social media feeds that to protect your other patients, you no longer accept families who refuse immunizations for the common childhood diseases.

The American Academy of Pediatrics says it feels your pain, and its Annual Leadership Forum made eliminating nonmedical vaccine exemption laws its top priority in 2019. As part of its effort to help, the AAP Board of Directors was asked to advocate for the creation of a toolkit of strategies for Academy chapters facing the challenge of nonmedical exemptions. As an initial step to this process, three physicians in the department of pediatrics at the Denver Health Medical Center have begun interviewing religious leaders in hopes of developing “clergy-specific vaccine educational materials and deriv[ing] best practices for engaging them as vaccination advocates.” The investigators describe their plan and initial findings in Pediatrics (2019 Oct. doi: 10.1542/peds.2019-0933). Although they acknowledged that their efforts may not provide a quick solution to the nonmedical exemption problem, they hope that including more stakeholders and engendering trust will help future discussions.

Fourteen pages deeper into that issue of Pediatrics is the runner-up submission of this year’s Section on Pediatric Trainees essay competition titled “What I Learned From the Antivaccine Movement” (2019 Oct. doi: 10.1542/peds.2019-2384). Alana C. Ju, MD, describes the 2-hour ordeal she endured to testify at the California State Capitol in support of a state Senate bill aimed at tightening the regulations for vaccine medical exemptions. Totally unprepared for the “level of vitriol” aimed at her and other supporters of the bill, she was “accused of violating her duty as” a pediatrician because she was failing to protect children. The supporters were called “greedy, ignorant, and negligent.”

To her credit, Dr. Ju was able to step back from this assault and began looking at the faces of her accusers and learned that, “they too, felt strongly about children’s health.” She realized that “focusing on perceived ignorance is counterproductive.” She now hopes that by focusing on the shared goal of what is best for children, “we can all be better advocates.”

Both of these articles have a warm sort of kumbaya feel about them. It never is a bad idea to learn more about those with whom we disagree. But before huddling up too close to the campfire, we must realize that there is good evidence that sharing the scientific data with vaccine-hesitant parents doesn’t convert them into vaccine acceptors. In fact, it may strengthen their resolve to resist (Nyhan et al. “Effective Messages in Vaccine Promotion: A Randomized Trial,” Pediatrics. 2014 Apr;133[4] e835-42).

We are unlikely to convert many anti-vaxxers by sitting down together. Our target audience needs to be legislators and the majority of people who do vaccinate their children. These are the voters who will support legislation to eliminate nonmedical vaccine exemptions. To characterize anti-vaxxers as despicable ignorants is untrue and serves no purpose. We all do care about the health of children. However, the evidence is clear that nonmedical exemptions are threatening the population at large and need to be curtailed.

Dr. Wilkoff practiced primary care pediatrics in Brunswick, Maine, for nearly 40 years. He has authored several books on behavioral pediatrics, including “How to Say No to Your Toddler.” Email him at [email protected].

*This article has been updated 1/22/2020.

NEW ORLEANS – Children who require more than 48 hours of intravenous therapy should receive long peripheral catheters initially rather than standard peripheral intravenous catheters, results from a randomized, controlled trial suggest.

Long peripheral catheters (LPCs) are relatively new, 8- to 15-cm long peripheral vascular devices that have been investigated extensively in adults. “It has been shown that these devices are safe and reliable peripheral vascular access devices for use in this population,” lead study author Maurizio Pacilli, MD, said in an interview in advance of the annual meeting of the American Academy of Pediatrics.

“In addition, LPCs may represent an improvement to the quality of care in adults, as demonstrated by multiple randomized controlled trials, where they outperformed peripheral intravenous catheters (PIVCs). There remains, however, a lack of controlled studies to determine if this effect is replicable in children.”

In what he said is the first study of its kind, Dr. Pacilli, a senior research fellow at Monash Children’s Hospital and Monash University, Melbourne, and colleagues performed an open-label randomized trial of 72 pediatric surgical patients aged 1 year and older who required more than 48 hours of IV therapy. They assigned 36 to receive a PIVCs while the remaining 36 children received an 8-cm 22-gauge LPC.

The mean age of patients was 9 years and 71% were boys. Dr. Pacilli reported that the IV therapy duration was a mean of 5 days, and that gender, age, weight, emergency status, and IV therapy duration were similar between the two groups. However, the mean lifespan of catheters was 3 days in PIVC group, compared with 5 days in the LPC group, a difference that reached statistical significance (P = .003). Patients in the PIVC group received a median of two catheters, compared with one in the LPC group (P = .0002). The researchers found that patients in the PIVC group were less likely than were those in the LPC group to complete treatment with a single catheter (39% vs. 81%, relative risk [RR] 2.1, P = .0006), while the rate of catheter failure was higher for PIVCs than for LPCs (67% vs. 19%, RR 3.4, P = .0001; 187 vs. 43 failures per 1,000 catheter days). Infiltration was the most common complication, and occurred in 33% of patients in the PIVC group vs. 3% in LPC group (RR 12, P = .001).

“Our results showed for the first time, without doubt, that children requiring more than 48 hours of intravenous therapy benefit from receiving LPCs, compared with traditional PIVCs,” Dr. Pacilli said. “Of failed catheters, PIVCs are most likely to infiltrate, while LPCs are most likely to occlude. This indicates an additional benefit of LPCs as occlusion is a relatively benign complication. In addition, in all domains of satisfaction, parents favor LPCs. According to the parents, there is a significant improvement in ‘pain and discomfort’ and ‘overall satisfaction’ with the use of LPCs in children.”

He acknowledged certain limitations of the study, including the fact that children younger than 1 year of age were not included in the analysis. “New devices, suitable for very young children, need to be developed, and further studies are needed to confirm the findings from our trial in children younger than 1 year,” he said.

Dr. Pacilli reported having no financial disclosures.

[email protected]

NEW ORLEANS – Children who require more than 48 hours of intravenous therapy should receive long peripheral catheters initially rather than standard peripheral intravenous catheters, results from a randomized, controlled trial suggest.

Long peripheral catheters (LPCs) are relatively new, 8- to 15-cm long peripheral vascular devices that have been investigated extensively in adults. “It has been shown that these devices are safe and reliable peripheral vascular access devices for use in this population,” lead study author Maurizio Pacilli, MD, said in an interview in advance of the annual meeting of the American Academy of Pediatrics.

“In addition, LPCs may represent an improvement to the quality of care in adults, as demonstrated by multiple randomized controlled trials, where they outperformed peripheral intravenous catheters (PIVCs). There remains, however, a lack of controlled studies to determine if this effect is replicable in children.”

In what he said is the first study of its kind, Dr. Pacilli, a senior research fellow at Monash Children’s Hospital and Monash University, Melbourne, and colleagues performed an open-label randomized trial of 72 pediatric surgical patients aged 1 year and older who required more than 48 hours of IV therapy. They assigned 36 to receive a PIVCs while the remaining 36 children received an 8-cm 22-gauge LPC.

The mean age of patients was 9 years and 71% were boys. Dr. Pacilli reported that the IV therapy duration was a mean of 5 days, and that gender, age, weight, emergency status, and IV therapy duration were similar between the two groups. However, the mean lifespan of catheters was 3 days in PIVC group, compared with 5 days in the LPC group, a difference that reached statistical significance (P = .003). Patients in the PIVC group received a median of two catheters, compared with one in the LPC group (P = .0002). The researchers found that patients in the PIVC group were less likely than were those in the LPC group to complete treatment with a single catheter (39% vs. 81%, relative risk [RR] 2.1, P = .0006), while the rate of catheter failure was higher for PIVCs than for LPCs (67% vs. 19%, RR 3.4, P = .0001; 187 vs. 43 failures per 1,000 catheter days). Infiltration was the most common complication, and occurred in 33% of patients in the PIVC group vs. 3% in LPC group (RR 12, P = .001).

“Our results showed for the first time, without doubt, that children requiring more than 48 hours of intravenous therapy benefit from receiving LPCs, compared with traditional PIVCs,” Dr. Pacilli said. “Of failed catheters, PIVCs are most likely to infiltrate, while LPCs are most likely to occlude. This indicates an additional benefit of LPCs as occlusion is a relatively benign complication. In addition, in all domains of satisfaction, parents favor LPCs. According to the parents, there is a significant improvement in ‘pain and discomfort’ and ‘overall satisfaction’ with the use of LPCs in children.”

He acknowledged certain limitations of the study, including the fact that children younger than 1 year of age were not included in the analysis. “New devices, suitable for very young children, need to be developed, and further studies are needed to confirm the findings from our trial in children younger than 1 year,” he said.

Dr. Pacilli reported having no financial disclosures.

[email protected]

NEW ORLEANS – Children who require more than 48 hours of intravenous therapy should receive long peripheral catheters initially rather than standard peripheral intravenous catheters, results from a randomized, controlled trial suggest.

Long peripheral catheters (LPCs) are relatively new, 8- to 15-cm long peripheral vascular devices that have been investigated extensively in adults. “It has been shown that these devices are safe and reliable peripheral vascular access devices for use in this population,” lead study author Maurizio Pacilli, MD, said in an interview in advance of the annual meeting of the American Academy of Pediatrics.

“In addition, LPCs may represent an improvement to the quality of care in adults, as demonstrated by multiple randomized controlled trials, where they outperformed peripheral intravenous catheters (PIVCs). There remains, however, a lack of controlled studies to determine if this effect is replicable in children.”

In what he said is the first study of its kind, Dr. Pacilli, a senior research fellow at Monash Children’s Hospital and Monash University, Melbourne, and colleagues performed an open-label randomized trial of 72 pediatric surgical patients aged 1 year and older who required more than 48 hours of IV therapy. They assigned 36 to receive a PIVCs while the remaining 36 children received an 8-cm 22-gauge LPC.

The mean age of patients was 9 years and 71% were boys. Dr. Pacilli reported that the IV therapy duration was a mean of 5 days, and that gender, age, weight, emergency status, and IV therapy duration were similar between the two groups. However, the mean lifespan of catheters was 3 days in PIVC group, compared with 5 days in the LPC group, a difference that reached statistical significance (P = .003). Patients in the PIVC group received a median of two catheters, compared with one in the LPC group (P = .0002). The researchers found that patients in the PIVC group were less likely than were those in the LPC group to complete treatment with a single catheter (39% vs. 81%, relative risk [RR] 2.1, P = .0006), while the rate of catheter failure was higher for PIVCs than for LPCs (67% vs. 19%, RR 3.4, P = .0001; 187 vs. 43 failures per 1,000 catheter days). Infiltration was the most common complication, and occurred in 33% of patients in the PIVC group vs. 3% in LPC group (RR 12, P = .001).

“Our results showed for the first time, without doubt, that children requiring more than 48 hours of intravenous therapy benefit from receiving LPCs, compared with traditional PIVCs,” Dr. Pacilli said. “Of failed catheters, PIVCs are most likely to infiltrate, while LPCs are most likely to occlude. This indicates an additional benefit of LPCs as occlusion is a relatively benign complication. In addition, in all domains of satisfaction, parents favor LPCs. According to the parents, there is a significant improvement in ‘pain and discomfort’ and ‘overall satisfaction’ with the use of LPCs in children.”

He acknowledged certain limitations of the study, including the fact that children younger than 1 year of age were not included in the analysis. “New devices, suitable for very young children, need to be developed, and further studies are needed to confirm the findings from our trial in children younger than 1 year,” he said.

Dr. Pacilli reported having no financial disclosures.

[email protected]