Immunology

About one-third of male teens in the United States reported receiving at least one dose of human papillomavirus vaccine, and only 13.9% received a complete series of three doses of the vaccine, although coverage among male adolescents significantly increased from 2010 to 2013, a study showed.*

National Cancer Institute

Dr. Peng-jun Lu of the Centers for Disease Control and Prevention and his associates used data from the 2013 National Immunization Survey–Teen, a national, random-digit-dial telephone survey sponsored by the CDC, to gather information from 6,039 adolescents between the ages of 13 and 17 years. They found coverage of greater than or equal to one dose was significantly higher among non-Hispanic blacks (42.2%) and Hispanics (49.6%), compared with non-Hispanic whites (26.7%). Similarly, human papillomavirus (HPV) vaccination coverage of three or more doses was significantly higher among non-Hispanic blacks (15.7%) and Hispanics (20.3%), compared with non-Hispanic whites (11.1%).

Parents who did not have their sons receive any HPV vaccinations commonly thought that the provider did not recommend them (24.0%), believed that the vaccinations were not needed or not necessary (18.9%), and had a general lack of knowledge (16.4%), the authors reported.

“To further increase HPV vaccination coverage … efforts should be directed to provide comprehensive, accessible, and appropriate communication messages on HPV and HPV vaccine directed to male adolescents and parents,” the researchers concluded.

Read the full article in Pediatrics (doi: 10.1542/peds.2015-1631).

*Correction, 11/4/2015: An earlier version of this story misstated the number of doses of the vaccine received by the study participants. A total of 34.6% reported receiving at least one dose.

About one-third of male teens in the United States reported receiving at least one dose of human papillomavirus vaccine, and only 13.9% received a complete series of three doses of the vaccine, although coverage among male adolescents significantly increased from 2010 to 2013, a study showed.*

National Cancer Institute

Dr. Peng-jun Lu of the Centers for Disease Control and Prevention and his associates used data from the 2013 National Immunization Survey–Teen, a national, random-digit-dial telephone survey sponsored by the CDC, to gather information from 6,039 adolescents between the ages of 13 and 17 years. They found coverage of greater than or equal to one dose was significantly higher among non-Hispanic blacks (42.2%) and Hispanics (49.6%), compared with non-Hispanic whites (26.7%). Similarly, human papillomavirus (HPV) vaccination coverage of three or more doses was significantly higher among non-Hispanic blacks (15.7%) and Hispanics (20.3%), compared with non-Hispanic whites (11.1%).

Parents who did not have their sons receive any HPV vaccinations commonly thought that the provider did not recommend them (24.0%), believed that the vaccinations were not needed or not necessary (18.9%), and had a general lack of knowledge (16.4%), the authors reported.

“To further increase HPV vaccination coverage … efforts should be directed to provide comprehensive, accessible, and appropriate communication messages on HPV and HPV vaccine directed to male adolescents and parents,” the researchers concluded.

Read the full article in Pediatrics (doi: 10.1542/peds.2015-1631).

*Correction, 11/4/2015: An earlier version of this story misstated the number of doses of the vaccine received by the study participants. A total of 34.6% reported receiving at least one dose.

About one-third of male teens in the United States reported receiving at least one dose of human papillomavirus vaccine, and only 13.9% received a complete series of three doses of the vaccine, although coverage among male adolescents significantly increased from 2010 to 2013, a study showed.*

National Cancer Institute

Dr. Peng-jun Lu of the Centers for Disease Control and Prevention and his associates used data from the 2013 National Immunization Survey–Teen, a national, random-digit-dial telephone survey sponsored by the CDC, to gather information from 6,039 adolescents between the ages of 13 and 17 years. They found coverage of greater than or equal to one dose was significantly higher among non-Hispanic blacks (42.2%) and Hispanics (49.6%), compared with non-Hispanic whites (26.7%). Similarly, human papillomavirus (HPV) vaccination coverage of three or more doses was significantly higher among non-Hispanic blacks (15.7%) and Hispanics (20.3%), compared with non-Hispanic whites (11.1%).

Parents who did not have their sons receive any HPV vaccinations commonly thought that the provider did not recommend them (24.0%), believed that the vaccinations were not needed or not necessary (18.9%), and had a general lack of knowledge (16.4%), the authors reported.

“To further increase HPV vaccination coverage … efforts should be directed to provide comprehensive, accessible, and appropriate communication messages on HPV and HPV vaccine directed to male adolescents and parents,” the researchers concluded.

Read the full article in Pediatrics (doi: 10.1542/peds.2015-1631).

*Correction, 11/4/2015: An earlier version of this story misstated the number of doses of the vaccine received by the study participants. A total of 34.6% reported receiving at least one dose.

COPENHAGEN – A novel topical nonsteroidal inhibitor of phosphodiesterase-4 showed a favorable efficacy to side effect ratio in a phase II study of adolescents and adults with mild to moderate atopic dermatitis, Dr. Jon M. Hanifin reported at the annual congress of the European Academy of Dermatology and Venereology.

“For topical agents, I think a 30% improvement with few side effects is a desirable balance,” observed Dr. Hanifin of Oregon Health and Sciences University, Portland.

The investigational agent, known for now as OPA-15406, is formulated as a twice-daily ointment. It is highly selective for the phosphodiesterase-4 (PDE-4) B subtype.

Dr. Hanifin noted that these are “exciting times” in the development of new topical therapies for atopic dermatitis (AD). In addition to the successful phase II study of OPA-15406 he presented, a highlight of the EADV congress was the strongly positive pivotal phase III data presented for crisaborole, another nonsteroidal topical PDE-4 inhibitor, albeit with a different mechanism of action.

For Dr. Hanifin these developments are particularly satisfying personally because 33 years ago as a young investigator – before the term ‘translational science’ had come into vogue – he and his research team made the seminal observation that increased phosphodiesterase activity is “a basic biochemical characteristic relevant to skin immunocellular regulation in atopic disease” (J Allergy Clin Immunol. 1982 Dec;70[6]:452-7).

The 8-week, multicenter, randomized, double-blind phase II OPA-15406 dose-ranging study included 121 patients, 70% with moderate AD, the rest with mild disease. About 20% were adolescents, the rest adults. Their mean baseline Eczema Area Severity Index (EASI) score was 9.5, with a self-reported pruritus score of 61 on a 0-100 scale. Participants were randomized to twice-daily application of OPA-15406 at 0.3% or 1% or the vehicle ointment as a control.

A significant treatment effect was seen within the first week. At 1 week, the mean EASI score was reduced by 31% from baseline in the 1% OPA-15406 group, 15% with the 0.3% formulation, and 6% with vehicle. The active treatment remained significantly more effective than vehicle throughout the 8-week period.

Another measure of efficacy – an Investigator’s Global Assessment (IGA) score of 0 (clear) or 1 along with at least a 2-point improvement on the 0-5 scale at week 4 – was met by 21% of patients on 1% OPA-15406, 15% on the 0.3% formulation, and 2.7% on vehicle. By the less stringent standard of an IGA of 0 or 1 plus at least a 1-point reduction at week 4, the success rates were 30%, 24%, and 10%.

Dr. Hanifin said the 1% formulation is the one likely to advance to phase III studies, given its superior efficacy. This was particularly evident with regard to itch. At the first evaluation, after just 1 week of treatment, pruritus scores showed a mean 30% reduction with 1% OPA-15406 versus no significant change in controls. He added that his clinical impression is that many patients experience a significant improvement in itching within the first 24 hours on the 1% formulation, an observation that deserves formal study.

Scores on the Dermatology Life Quality Index and Children’s Dermatology Life Quality Index were significantly better in the active therapy arms than with vehicle as early as week 1.

The adverse events findings were “not very exciting,” according to the dermatologist. No treatment-related serious adverse events occurred. The two most common adverse events leading to treatment discontinuation – worsening AD and pruritus – occurred more often in the vehicle-treated controls.

Session cochair Dr. Jacek Szepietowski called the pruritus results particularly impressive.

“It’s very difficult to do successful clinical trials of topicals for atopic dermatitis because the vehicle alone, especially if it’s an ointment, can have favorable effects which increase over time both on EASI and pruritus,” commented Dr. Szepietowski, professor and head of the department of dermatology, venereology, and allergology at the Medical University of Wroclaw (Poland).

The study was sponsored by Otsuka Pharmaceuticals. Dr. Hanifin reported serving as a consultant to and paid investigator for the company.

[email protected]

COPENHAGEN – A novel topical nonsteroidal inhibitor of phosphodiesterase-4 showed a favorable efficacy to side effect ratio in a phase II study of adolescents and adults with mild to moderate atopic dermatitis, Dr. Jon M. Hanifin reported at the annual congress of the European Academy of Dermatology and Venereology.

“For topical agents, I think a 30% improvement with few side effects is a desirable balance,” observed Dr. Hanifin of Oregon Health and Sciences University, Portland.

The investigational agent, known for now as OPA-15406, is formulated as a twice-daily ointment. It is highly selective for the phosphodiesterase-4 (PDE-4) B subtype.

Dr. Hanifin noted that these are “exciting times” in the development of new topical therapies for atopic dermatitis (AD). In addition to the successful phase II study of OPA-15406 he presented, a highlight of the EADV congress was the strongly positive pivotal phase III data presented for crisaborole, another nonsteroidal topical PDE-4 inhibitor, albeit with a different mechanism of action.

For Dr. Hanifin these developments are particularly satisfying personally because 33 years ago as a young investigator – before the term ‘translational science’ had come into vogue – he and his research team made the seminal observation that increased phosphodiesterase activity is “a basic biochemical characteristic relevant to skin immunocellular regulation in atopic disease” (J Allergy Clin Immunol. 1982 Dec;70[6]:452-7).

The 8-week, multicenter, randomized, double-blind phase II OPA-15406 dose-ranging study included 121 patients, 70% with moderate AD, the rest with mild disease. About 20% were adolescents, the rest adults. Their mean baseline Eczema Area Severity Index (EASI) score was 9.5, with a self-reported pruritus score of 61 on a 0-100 scale. Participants were randomized to twice-daily application of OPA-15406 at 0.3% or 1% or the vehicle ointment as a control.

A significant treatment effect was seen within the first week. At 1 week, the mean EASI score was reduced by 31% from baseline in the 1% OPA-15406 group, 15% with the 0.3% formulation, and 6% with vehicle. The active treatment remained significantly more effective than vehicle throughout the 8-week period.

Another measure of efficacy – an Investigator’s Global Assessment (IGA) score of 0 (clear) or 1 along with at least a 2-point improvement on the 0-5 scale at week 4 – was met by 21% of patients on 1% OPA-15406, 15% on the 0.3% formulation, and 2.7% on vehicle. By the less stringent standard of an IGA of 0 or 1 plus at least a 1-point reduction at week 4, the success rates were 30%, 24%, and 10%.

Dr. Hanifin said the 1% formulation is the one likely to advance to phase III studies, given its superior efficacy. This was particularly evident with regard to itch. At the first evaluation, after just 1 week of treatment, pruritus scores showed a mean 30% reduction with 1% OPA-15406 versus no significant change in controls. He added that his clinical impression is that many patients experience a significant improvement in itching within the first 24 hours on the 1% formulation, an observation that deserves formal study.

Scores on the Dermatology Life Quality Index and Children’s Dermatology Life Quality Index were significantly better in the active therapy arms than with vehicle as early as week 1.

The adverse events findings were “not very exciting,” according to the dermatologist. No treatment-related serious adverse events occurred. The two most common adverse events leading to treatment discontinuation – worsening AD and pruritus – occurred more often in the vehicle-treated controls.

Session cochair Dr. Jacek Szepietowski called the pruritus results particularly impressive.

“It’s very difficult to do successful clinical trials of topicals for atopic dermatitis because the vehicle alone, especially if it’s an ointment, can have favorable effects which increase over time both on EASI and pruritus,” commented Dr. Szepietowski, professor and head of the department of dermatology, venereology, and allergology at the Medical University of Wroclaw (Poland).

The study was sponsored by Otsuka Pharmaceuticals. Dr. Hanifin reported serving as a consultant to and paid investigator for the company.

[email protected]

COPENHAGEN – A novel topical nonsteroidal inhibitor of phosphodiesterase-4 showed a favorable efficacy to side effect ratio in a phase II study of adolescents and adults with mild to moderate atopic dermatitis, Dr. Jon M. Hanifin reported at the annual congress of the European Academy of Dermatology and Venereology.

“For topical agents, I think a 30% improvement with few side effects is a desirable balance,” observed Dr. Hanifin of Oregon Health and Sciences University, Portland.

The investigational agent, known for now as OPA-15406, is formulated as a twice-daily ointment. It is highly selective for the phosphodiesterase-4 (PDE-4) B subtype.

Dr. Hanifin noted that these are “exciting times” in the development of new topical therapies for atopic dermatitis (AD). In addition to the successful phase II study of OPA-15406 he presented, a highlight of the EADV congress was the strongly positive pivotal phase III data presented for crisaborole, another nonsteroidal topical PDE-4 inhibitor, albeit with a different mechanism of action.

For Dr. Hanifin these developments are particularly satisfying personally because 33 years ago as a young investigator – before the term ‘translational science’ had come into vogue – he and his research team made the seminal observation that increased phosphodiesterase activity is “a basic biochemical characteristic relevant to skin immunocellular regulation in atopic disease” (J Allergy Clin Immunol. 1982 Dec;70[6]:452-7).

The 8-week, multicenter, randomized, double-blind phase II OPA-15406 dose-ranging study included 121 patients, 70% with moderate AD, the rest with mild disease. About 20% were adolescents, the rest adults. Their mean baseline Eczema Area Severity Index (EASI) score was 9.5, with a self-reported pruritus score of 61 on a 0-100 scale. Participants were randomized to twice-daily application of OPA-15406 at 0.3% or 1% or the vehicle ointment as a control.

A significant treatment effect was seen within the first week. At 1 week, the mean EASI score was reduced by 31% from baseline in the 1% OPA-15406 group, 15% with the 0.3% formulation, and 6% with vehicle. The active treatment remained significantly more effective than vehicle throughout the 8-week period.

Another measure of efficacy – an Investigator’s Global Assessment (IGA) score of 0 (clear) or 1 along with at least a 2-point improvement on the 0-5 scale at week 4 – was met by 21% of patients on 1% OPA-15406, 15% on the 0.3% formulation, and 2.7% on vehicle. By the less stringent standard of an IGA of 0 or 1 plus at least a 1-point reduction at week 4, the success rates were 30%, 24%, and 10%.

Dr. Hanifin said the 1% formulation is the one likely to advance to phase III studies, given its superior efficacy. This was particularly evident with regard to itch. At the first evaluation, after just 1 week of treatment, pruritus scores showed a mean 30% reduction with 1% OPA-15406 versus no significant change in controls. He added that his clinical impression is that many patients experience a significant improvement in itching within the first 24 hours on the 1% formulation, an observation that deserves formal study.

Scores on the Dermatology Life Quality Index and Children’s Dermatology Life Quality Index were significantly better in the active therapy arms than with vehicle as early as week 1.

The adverse events findings were “not very exciting,” according to the dermatologist. No treatment-related serious adverse events occurred. The two most common adverse events leading to treatment discontinuation – worsening AD and pruritus – occurred more often in the vehicle-treated controls.

Session cochair Dr. Jacek Szepietowski called the pruritus results particularly impressive.

“It’s very difficult to do successful clinical trials of topicals for atopic dermatitis because the vehicle alone, especially if it’s an ointment, can have favorable effects which increase over time both on EASI and pruritus,” commented Dr. Szepietowski, professor and head of the department of dermatology, venereology, and allergology at the Medical University of Wroclaw (Poland).

The study was sponsored by Otsuka Pharmaceuticals. Dr. Hanifin reported serving as a consultant to and paid investigator for the company.

[email protected]

Inconsistent recommendation of the HPV vaccine and discomfort discussing the HPV vaccine are common among primary care providers, likely contributing to its poor uptake, according to a recent study.

“Half of the primary care physicians in our national sample reported at least two communication practices that likely compromise their ability to meet guidelines for the routine delivery of the HPV vaccine,” reported Melissa B. Gilkey, Ph.D., of Harvard Medical School in Boston, and her associates.

©dina2001/thinkstockphotos.com

“Many pediatricians and family physicians in our national sample reported recommending the HPV vaccine inconsistently, behind schedule, or without urgency,” they wrote (Cancer Epidemiol Biomarkers Prev. 2015 Oct 22. doi: 10.1158/1055-9965.EPI-15-0326).

Of 2,368 pediatricians and family physicians sent an online survey for the study, 1,022 responded and 776 met the criteria and completed the survey about provider beliefs, attitudes and behaviors surrounding HPV vaccine administration. Two-thirds (68%) of respondents were male, and more than half (55%) had at least 2 decades of practice; the group was nearly evenly split between pediatricians (53%) and family doctors (47%). Most of them (83%) saw 10 or more adolescent patients per week.

Just over a quarter (26%) did not recommend the vaccine on time – between ages 11 and 12 years – for female patients, and 39% did not recommend it on time for male patients. Well over half (59%) used a risk-based approach in recommending the HPV rather than a consistent routine recommendation. Similarly, half (49%) did not recommend the vaccine the same day. About a third (34%) anticipated uncomfortable conversations about the vaccine or about HPV as a sexually transmitted infection (32%), and 47% felt parents saw the vaccine as unimportant or only slightly important for their preteens.

A large majority of doctors (84%) felt the tone of the conversation to be at least as important as the content of what they say. They perceived greater parent receptivity to the vaccine with an informative (76%) or nonjudgmental tone (44%). Fewer doctors reported high receptivity with a concerned (23%), warm (22%), or upbeat (13%) tone.

A third of the doctors (34%) start the conversation with information, 30% start saying the child is due for the vaccine, and 29% start by suggesting the vaccine. While 99% of the doctors told patients and parents that the HPV vaccine prevents cervical cancer, 84% mentioned prevention of genital warts, and 55% mentioned preventing other cancers.

“Interventions are urgently needed to help physicians improve their HPV vaccine recommendations, and the quality indicators of timeliness, consistency, urgency and strength of endorsement offer one framework for guiding these efforts,” Dr. Gilkey and her associates wrote. “By improving how physicians recommend HPV vaccine, we can raise national coverage, thereby ensuring that today’s youth enjoy the full benefit of a potent tool for cancer prevention.”

The research was funded by Pfizer, the University of North Carolina Lineberger Comprehensive Cancer Center, and the National Cancer Institute. Dr. Brewer reports research grants from Merck, Pfizer, and GlaxoSmithKline, speaker honoraria from Merck, and consultancy for Merck.

Inconsistent recommendation of the HPV vaccine and discomfort discussing the HPV vaccine are common among primary care providers, likely contributing to its poor uptake, according to a recent study.

“Half of the primary care physicians in our national sample reported at least two communication practices that likely compromise their ability to meet guidelines for the routine delivery of the HPV vaccine,” reported Melissa B. Gilkey, Ph.D., of Harvard Medical School in Boston, and her associates.

©dina2001/thinkstockphotos.com

“Many pediatricians and family physicians in our national sample reported recommending the HPV vaccine inconsistently, behind schedule, or without urgency,” they wrote (Cancer Epidemiol Biomarkers Prev. 2015 Oct 22. doi: 10.1158/1055-9965.EPI-15-0326).

Of 2,368 pediatricians and family physicians sent an online survey for the study, 1,022 responded and 776 met the criteria and completed the survey about provider beliefs, attitudes and behaviors surrounding HPV vaccine administration. Two-thirds (68%) of respondents were male, and more than half (55%) had at least 2 decades of practice; the group was nearly evenly split between pediatricians (53%) and family doctors (47%). Most of them (83%) saw 10 or more adolescent patients per week.

Just over a quarter (26%) did not recommend the vaccine on time – between ages 11 and 12 years – for female patients, and 39% did not recommend it on time for male patients. Well over half (59%) used a risk-based approach in recommending the HPV rather than a consistent routine recommendation. Similarly, half (49%) did not recommend the vaccine the same day. About a third (34%) anticipated uncomfortable conversations about the vaccine or about HPV as a sexually transmitted infection (32%), and 47% felt parents saw the vaccine as unimportant or only slightly important for their preteens.

A large majority of doctors (84%) felt the tone of the conversation to be at least as important as the content of what they say. They perceived greater parent receptivity to the vaccine with an informative (76%) or nonjudgmental tone (44%). Fewer doctors reported high receptivity with a concerned (23%), warm (22%), or upbeat (13%) tone.

A third of the doctors (34%) start the conversation with information, 30% start saying the child is due for the vaccine, and 29% start by suggesting the vaccine. While 99% of the doctors told patients and parents that the HPV vaccine prevents cervical cancer, 84% mentioned prevention of genital warts, and 55% mentioned preventing other cancers.

“Interventions are urgently needed to help physicians improve their HPV vaccine recommendations, and the quality indicators of timeliness, consistency, urgency and strength of endorsement offer one framework for guiding these efforts,” Dr. Gilkey and her associates wrote. “By improving how physicians recommend HPV vaccine, we can raise national coverage, thereby ensuring that today’s youth enjoy the full benefit of a potent tool for cancer prevention.”

The research was funded by Pfizer, the University of North Carolina Lineberger Comprehensive Cancer Center, and the National Cancer Institute. Dr. Brewer reports research grants from Merck, Pfizer, and GlaxoSmithKline, speaker honoraria from Merck, and consultancy for Merck.

Inconsistent recommendation of the HPV vaccine and discomfort discussing the HPV vaccine are common among primary care providers, likely contributing to its poor uptake, according to a recent study.

“Half of the primary care physicians in our national sample reported at least two communication practices that likely compromise their ability to meet guidelines for the routine delivery of the HPV vaccine,” reported Melissa B. Gilkey, Ph.D., of Harvard Medical School in Boston, and her associates.

©dina2001/thinkstockphotos.com

“Many pediatricians and family physicians in our national sample reported recommending the HPV vaccine inconsistently, behind schedule, or without urgency,” they wrote (Cancer Epidemiol Biomarkers Prev. 2015 Oct 22. doi: 10.1158/1055-9965.EPI-15-0326).

Of 2,368 pediatricians and family physicians sent an online survey for the study, 1,022 responded and 776 met the criteria and completed the survey about provider beliefs, attitudes and behaviors surrounding HPV vaccine administration. Two-thirds (68%) of respondents were male, and more than half (55%) had at least 2 decades of practice; the group was nearly evenly split between pediatricians (53%) and family doctors (47%). Most of them (83%) saw 10 or more adolescent patients per week.

Just over a quarter (26%) did not recommend the vaccine on time – between ages 11 and 12 years – for female patients, and 39% did not recommend it on time for male patients. Well over half (59%) used a risk-based approach in recommending the HPV rather than a consistent routine recommendation. Similarly, half (49%) did not recommend the vaccine the same day. About a third (34%) anticipated uncomfortable conversations about the vaccine or about HPV as a sexually transmitted infection (32%), and 47% felt parents saw the vaccine as unimportant or only slightly important for their preteens.

A large majority of doctors (84%) felt the tone of the conversation to be at least as important as the content of what they say. They perceived greater parent receptivity to the vaccine with an informative (76%) or nonjudgmental tone (44%). Fewer doctors reported high receptivity with a concerned (23%), warm (22%), or upbeat (13%) tone.

A third of the doctors (34%) start the conversation with information, 30% start saying the child is due for the vaccine, and 29% start by suggesting the vaccine. While 99% of the doctors told patients and parents that the HPV vaccine prevents cervical cancer, 84% mentioned prevention of genital warts, and 55% mentioned preventing other cancers.

“Interventions are urgently needed to help physicians improve their HPV vaccine recommendations, and the quality indicators of timeliness, consistency, urgency and strength of endorsement offer one framework for guiding these efforts,” Dr. Gilkey and her associates wrote. “By improving how physicians recommend HPV vaccine, we can raise national coverage, thereby ensuring that today’s youth enjoy the full benefit of a potent tool for cancer prevention.”

The research was funded by Pfizer, the University of North Carolina Lineberger Comprehensive Cancer Center, and the National Cancer Institute. Dr. Brewer reports research grants from Merck, Pfizer, and GlaxoSmithKline, speaker honoraria from Merck, and consultancy for Merck.

Physicians are being encouraged to do more to help promote food security, according to a new policy statement issued by the American Academy of Pediatrics.

The organization’s Council on Community Pediatrics’ Committee on Nutrition is recommending screening patients for food insecurity during scheduled health maintenance visits or sooner; becoming familiar with community resources, such as the Special Supplemental Nutrition Program for Women, Infants and Children (WIC), SNAP, school nutrition programs, local food pantries, summer and child care feeding programs, and other programs to refer those who may have food insecurity issues; and be aware of the factors that may increase food insecurity.

©stevanovicigor/thinkstockphotos.com

AAP’s policy was published Oct. 23 in Pediatrics (2015 Oct. 23 [doi: 10.1542/peds.2015-3301]).

Erin R. Hager, Ph.D., et al. designed a practical in-office two-item screening tool. Answering “yes” to either of the questions identified food insecurity with a sensitivity of 97% and a specificity of 83% (Pediatrics. 2010 Jul;126[1]:e26-e32). The two screening items are as follows:

1. Within the past 12 months, we worried whether our food would run out before we got money to buy more. (Yes or No)

2. Within the past 12 months, the food we bought just didn’t last and we didn’t have money to get more. (Yes or No)

The statement notes that in 2013, “17.5 million U.S. households, or 14.3% of all households and 21% of all children, met the U.S. Department of Agriculture definition of a food-insecure household, one in which access to adequate food is limited by a lack of money or other resources.” And while poverty is a key factor leading to food insecurity, it adds that food insecurity “is associated with many factors. ... Unemployment and underemployment are also strongly associated with food insecurity.” Families at risk include immigrants, those that are large, those headed by single women, those with less education, and those experiencing parental separation or divorce.

Children with food insecurity also “have poorer overall health and more hospitalizations than do children who live in food-secure households.” Additionally, food insecurity could be an indirect cause for obesity and is linked with lower cognitive indicators, dysregulated behavior, and emotional distress.

In the office, be aware of factors that may increase vulnerability of food-insecure populations to obesity, such as “lack of access to healthy and affordable foods, cost of healthy food (and the low cost of many unhealthy foods), media messaging that promotes nonnutritious foods and beverages, and the role of stress in decision-making related to food,” according to the statement.

On a national advocacy level, AAP also is calling for food insecurity, including screening tools and community resource guidelines, to be incorporated into medical school education; and for support for interdisciplinary research to better understand the relationship between stress, food insecurity, and adverse health consequences.

Physicians are being encouraged to do more to help promote food security, according to a new policy statement issued by the American Academy of Pediatrics.

The organization’s Council on Community Pediatrics’ Committee on Nutrition is recommending screening patients for food insecurity during scheduled health maintenance visits or sooner; becoming familiar with community resources, such as the Special Supplemental Nutrition Program for Women, Infants and Children (WIC), SNAP, school nutrition programs, local food pantries, summer and child care feeding programs, and other programs to refer those who may have food insecurity issues; and be aware of the factors that may increase food insecurity.

©stevanovicigor/thinkstockphotos.com

AAP’s policy was published Oct. 23 in Pediatrics (2015 Oct. 23 [doi: 10.1542/peds.2015-3301]).

Erin R. Hager, Ph.D., et al. designed a practical in-office two-item screening tool. Answering “yes” to either of the questions identified food insecurity with a sensitivity of 97% and a specificity of 83% (Pediatrics. 2010 Jul;126[1]:e26-e32). The two screening items are as follows:

1. Within the past 12 months, we worried whether our food would run out before we got money to buy more. (Yes or No)

2. Within the past 12 months, the food we bought just didn’t last and we didn’t have money to get more. (Yes or No)

The statement notes that in 2013, “17.5 million U.S. households, or 14.3% of all households and 21% of all children, met the U.S. Department of Agriculture definition of a food-insecure household, one in which access to adequate food is limited by a lack of money or other resources.” And while poverty is a key factor leading to food insecurity, it adds that food insecurity “is associated with many factors. ... Unemployment and underemployment are also strongly associated with food insecurity.” Families at risk include immigrants, those that are large, those headed by single women, those with less education, and those experiencing parental separation or divorce.

Children with food insecurity also “have poorer overall health and more hospitalizations than do children who live in food-secure households.” Additionally, food insecurity could be an indirect cause for obesity and is linked with lower cognitive indicators, dysregulated behavior, and emotional distress.

In the office, be aware of factors that may increase vulnerability of food-insecure populations to obesity, such as “lack of access to healthy and affordable foods, cost of healthy food (and the low cost of many unhealthy foods), media messaging that promotes nonnutritious foods and beverages, and the role of stress in decision-making related to food,” according to the statement.

On a national advocacy level, AAP also is calling for food insecurity, including screening tools and community resource guidelines, to be incorporated into medical school education; and for support for interdisciplinary research to better understand the relationship between stress, food insecurity, and adverse health consequences.

Physicians are being encouraged to do more to help promote food security, according to a new policy statement issued by the American Academy of Pediatrics.

The organization’s Council on Community Pediatrics’ Committee on Nutrition is recommending screening patients for food insecurity during scheduled health maintenance visits or sooner; becoming familiar with community resources, such as the Special Supplemental Nutrition Program for Women, Infants and Children (WIC), SNAP, school nutrition programs, local food pantries, summer and child care feeding programs, and other programs to refer those who may have food insecurity issues; and be aware of the factors that may increase food insecurity.

©stevanovicigor/thinkstockphotos.com

AAP’s policy was published Oct. 23 in Pediatrics (2015 Oct. 23 [doi: 10.1542/peds.2015-3301]).

Erin R. Hager, Ph.D., et al. designed a practical in-office two-item screening tool. Answering “yes” to either of the questions identified food insecurity with a sensitivity of 97% and a specificity of 83% (Pediatrics. 2010 Jul;126[1]:e26-e32). The two screening items are as follows:

1. Within the past 12 months, we worried whether our food would run out before we got money to buy more. (Yes or No)

2. Within the past 12 months, the food we bought just didn’t last and we didn’t have money to get more. (Yes or No)

The statement notes that in 2013, “17.5 million U.S. households, or 14.3% of all households and 21% of all children, met the U.S. Department of Agriculture definition of a food-insecure household, one in which access to adequate food is limited by a lack of money or other resources.” And while poverty is a key factor leading to food insecurity, it adds that food insecurity “is associated with many factors. ... Unemployment and underemployment are also strongly associated with food insecurity.” Families at risk include immigrants, those that are large, those headed by single women, those with less education, and those experiencing parental separation or divorce.

Children with food insecurity also “have poorer overall health and more hospitalizations than do children who live in food-secure households.” Additionally, food insecurity could be an indirect cause for obesity and is linked with lower cognitive indicators, dysregulated behavior, and emotional distress.

In the office, be aware of factors that may increase vulnerability of food-insecure populations to obesity, such as “lack of access to healthy and affordable foods, cost of healthy food (and the low cost of many unhealthy foods), media messaging that promotes nonnutritious foods and beverages, and the role of stress in decision-making related to food,” according to the statement.

On a national advocacy level, AAP also is calling for food insecurity, including screening tools and community resource guidelines, to be incorporated into medical school education; and for support for interdisciplinary research to better understand the relationship between stress, food insecurity, and adverse health consequences.

Changes to meningococcal B, DTaP, polio, and human papillomavirus (HPV) vaccination recommendations were among those unanimously approved at a meeting of the Centers for Disease Control and Prevention’s Advisory Committee on Immunization Practices (ACIP) for child and adolescent immunization schedules.

Meningococcal B vaccine has now been added to the 2016 immunization schedule, and is recommended for high-risk children beginning at age 10 years. The schedule also includes recommendations for adolescents age 16 years and older in “not high-risk groups that may receive this vaccine subject to individual clinical decision-making,” according to Dr. Candice Robinson of the CDC’s National Center for Immunization and Respiratory Diseases, Atlanta. Relevant information for administration of meningococcal B vaccination has been added to the footnotes and routine vaccination sections as well.

In the footnotes section, DTaP recommendations have been revised to add Quadracel to the minimum age exception line, and administration instructions of inadvertent doses have been clarified. The new instructions will now read: “If the fourth dose of DTaP was administered at least 4 months, but less than 6 months, after the third dose of DTaP, it need not be repeated [and] the 4-day grace period may not be used for the fourth dose given less than 6 months after the third dose of DTaP.”

“We use the description of ‘inadvertent dose’ to indicate that this shortened interval between doses should not be used prospectively; however, the dose could be counted as valid after the fact,” Dr. Robinson explained.

Footnotes for inactivated polio vaccine (IPV) will now include guidance for IPV use in patients who have previously received only oral polio vaccine (OPV) and did not receive any doses after their fourth birthday. This addition, which was added after repeated inquiries from providers, will read: “If only OPV were administered, and all doses were given prior to 4 years of age, one dose of IPV should be given at 4 years or older at least 4 weeks after the last dose of [OPV].”

©dina2001/thinkstockphotos.com

For HPV, children aged 9-10 years will now be recommended for vaccination if they are “high risk” – indicated by a purple bar on Figure 1 of the 2016 immunization schedule – due to a history of sexual abuse in their youth. Furthermore, all HPV nomenclature in the 2016 recommendations will be updated to reflect currently accepted naming formats; for example, HPV4 will now be called 4-valent or 4V HPV. In the footnotes, the 9-valent HPV vaccine is now included along with the 5-valent and 4-valent variants, along with restructured language to clarify administration instructions.

Other changes to Figure 1 of next year’s immunization schedules include moving the Tdap recommendations to a lower section of the table, and moving the pneumococcal polysaccharide vaccination schedule toward the bottom of the chart because it is “not routinely recommended for any population.” Haemophilus influenzae type b (Hib) vaccinations are now recommended for certain high-risk groups in patients aged 5-18 years, in accordance with text in the recommendations’ footnotes that suggested vaccination in this age group for those who had previously been vaccinated or have other high-risk conditions.

The catch-up schedule will have one minor change – “in the Tdap line’s Dose 2-3 column, we added Tdap and Td to the list of possible previous vaccines,” Dr. Robinson said.

Revisions will be made to be submitted for approval by Dr. Tom Frieden, CDC director. The edited copy of these updated recommendations will be submitted to the American Academy of Pediatrics, American Academy of Family Physicians, and American Congress of Obstetricians and Gynecologists by Jan. 1, 2016, with publication by the CDC and partner publications following in January and February.

Changes to meningococcal B, DTaP, polio, and human papillomavirus (HPV) vaccination recommendations were among those unanimously approved at a meeting of the Centers for Disease Control and Prevention’s Advisory Committee on Immunization Practices (ACIP) for child and adolescent immunization schedules.

Meningococcal B vaccine has now been added to the 2016 immunization schedule, and is recommended for high-risk children beginning at age 10 years. The schedule also includes recommendations for adolescents age 16 years and older in “not high-risk groups that may receive this vaccine subject to individual clinical decision-making,” according to Dr. Candice Robinson of the CDC’s National Center for Immunization and Respiratory Diseases, Atlanta. Relevant information for administration of meningococcal B vaccination has been added to the footnotes and routine vaccination sections as well.

In the footnotes section, DTaP recommendations have been revised to add Quadracel to the minimum age exception line, and administration instructions of inadvertent doses have been clarified. The new instructions will now read: “If the fourth dose of DTaP was administered at least 4 months, but less than 6 months, after the third dose of DTaP, it need not be repeated [and] the 4-day grace period may not be used for the fourth dose given less than 6 months after the third dose of DTaP.”

“We use the description of ‘inadvertent dose’ to indicate that this shortened interval between doses should not be used prospectively; however, the dose could be counted as valid after the fact,” Dr. Robinson explained.

Footnotes for inactivated polio vaccine (IPV) will now include guidance for IPV use in patients who have previously received only oral polio vaccine (OPV) and did not receive any doses after their fourth birthday. This addition, which was added after repeated inquiries from providers, will read: “If only OPV were administered, and all doses were given prior to 4 years of age, one dose of IPV should be given at 4 years or older at least 4 weeks after the last dose of [OPV].”

©dina2001/thinkstockphotos.com

For HPV, children aged 9-10 years will now be recommended for vaccination if they are “high risk” – indicated by a purple bar on Figure 1 of the 2016 immunization schedule – due to a history of sexual abuse in their youth. Furthermore, all HPV nomenclature in the 2016 recommendations will be updated to reflect currently accepted naming formats; for example, HPV4 will now be called 4-valent or 4V HPV. In the footnotes, the 9-valent HPV vaccine is now included along with the 5-valent and 4-valent variants, along with restructured language to clarify administration instructions.

Other changes to Figure 1 of next year’s immunization schedules include moving the Tdap recommendations to a lower section of the table, and moving the pneumococcal polysaccharide vaccination schedule toward the bottom of the chart because it is “not routinely recommended for any population.” Haemophilus influenzae type b (Hib) vaccinations are now recommended for certain high-risk groups in patients aged 5-18 years, in accordance with text in the recommendations’ footnotes that suggested vaccination in this age group for those who had previously been vaccinated or have other high-risk conditions.

The catch-up schedule will have one minor change – “in the Tdap line’s Dose 2-3 column, we added Tdap and Td to the list of possible previous vaccines,” Dr. Robinson said.

Revisions will be made to be submitted for approval by Dr. Tom Frieden, CDC director. The edited copy of these updated recommendations will be submitted to the American Academy of Pediatrics, American Academy of Family Physicians, and American Congress of Obstetricians and Gynecologists by Jan. 1, 2016, with publication by the CDC and partner publications following in January and February.

Changes to meningococcal B, DTaP, polio, and human papillomavirus (HPV) vaccination recommendations were among those unanimously approved at a meeting of the Centers for Disease Control and Prevention’s Advisory Committee on Immunization Practices (ACIP) for child and adolescent immunization schedules.

Meningococcal B vaccine has now been added to the 2016 immunization schedule, and is recommended for high-risk children beginning at age 10 years. The schedule also includes recommendations for adolescents age 16 years and older in “not high-risk groups that may receive this vaccine subject to individual clinical decision-making,” according to Dr. Candice Robinson of the CDC’s National Center for Immunization and Respiratory Diseases, Atlanta. Relevant information for administration of meningococcal B vaccination has been added to the footnotes and routine vaccination sections as well.

In the footnotes section, DTaP recommendations have been revised to add Quadracel to the minimum age exception line, and administration instructions of inadvertent doses have been clarified. The new instructions will now read: “If the fourth dose of DTaP was administered at least 4 months, but less than 6 months, after the third dose of DTaP, it need not be repeated [and] the 4-day grace period may not be used for the fourth dose given less than 6 months after the third dose of DTaP.”

“We use the description of ‘inadvertent dose’ to indicate that this shortened interval between doses should not be used prospectively; however, the dose could be counted as valid after the fact,” Dr. Robinson explained.

Footnotes for inactivated polio vaccine (IPV) will now include guidance for IPV use in patients who have previously received only oral polio vaccine (OPV) and did not receive any doses after their fourth birthday. This addition, which was added after repeated inquiries from providers, will read: “If only OPV were administered, and all doses were given prior to 4 years of age, one dose of IPV should be given at 4 years or older at least 4 weeks after the last dose of [OPV].”

©dina2001/thinkstockphotos.com

For HPV, children aged 9-10 years will now be recommended for vaccination if they are “high risk” – indicated by a purple bar on Figure 1 of the 2016 immunization schedule – due to a history of sexual abuse in their youth. Furthermore, all HPV nomenclature in the 2016 recommendations will be updated to reflect currently accepted naming formats; for example, HPV4 will now be called 4-valent or 4V HPV. In the footnotes, the 9-valent HPV vaccine is now included along with the 5-valent and 4-valent variants, along with restructured language to clarify administration instructions.

Other changes to Figure 1 of next year’s immunization schedules include moving the Tdap recommendations to a lower section of the table, and moving the pneumococcal polysaccharide vaccination schedule toward the bottom of the chart because it is “not routinely recommended for any population.” Haemophilus influenzae type b (Hib) vaccinations are now recommended for certain high-risk groups in patients aged 5-18 years, in accordance with text in the recommendations’ footnotes that suggested vaccination in this age group for those who had previously been vaccinated or have other high-risk conditions.

The catch-up schedule will have one minor change – “in the Tdap line’s Dose 2-3 column, we added Tdap and Td to the list of possible previous vaccines,” Dr. Robinson said.

Revisions will be made to be submitted for approval by Dr. Tom Frieden, CDC director. The edited copy of these updated recommendations will be submitted to the American Academy of Pediatrics, American Academy of Family Physicians, and American Congress of Obstetricians and Gynecologists by Jan. 1, 2016, with publication by the CDC and partner publications following in January and February.

Receiving the tetanus, diphtheria, acellular pertussis vaccine during pregnancy does not increase the risk of adverse events for mother or baby, even if the mother has previously received the vaccine within the past 2 years, according to a report published Oct. 20 in JAMA.

Women should receive a Tdap vaccination during each pregnancy – preferably in the third trimester – so that the fetus receives some maternal antibodies against pertussis for limited protection until the first DTaP vaccine at age 2 months, according to 2012 recommendation from the Advisory Committee on Immunization Practices (ACIP). Yet previous research has not clarified the safety of repeated doses of maternal Tdap immunization.

©AvailableLight/istockphoto.com

“These findings suggest that relatively recent receipt of a prior tetanus-containing vaccination does not increase risk after Tdap vaccination in pregnancy,” wrote Dr. Lakshmi Sukumaran of the Centers for Disease Control and Prevention Immunization Safety Office, and colleagues. “Our findings should reassure patients and clinicians who might be hesitant to give Tdap vaccine to pregnant women who recently received a Tdap or other tetanus-containing vaccination.”

In the retrospective cohort study involving pregnancies between Jan. 1, 2007, through Nov. 15, 2013, the researchers examined data from 29,155 pregnant women, aged 14-49, who enrolled in seven Vaccine Safety Datalink sites in California, Colorado, Minnesota, Oregon, Washington, and Wisconsin.

The researchers compared the 49% of women who had received a tetanus-containing vaccine more than 5 years before their current pregnancy (controls) with the 17% of women who had received a tetanus-containing vaccine less than 2 years before, and the 34% of women who had been vaccinated 2-5 years earlier. More than two-thirds of the women (67.4%) received the Tdap during the third trimester, compared with 27.5% in the second trimester, and 5.1% in the first trimester (JAMA. 2015;314[15]:1581-7. doi: 10.1001/jama.2015.12790).

The researchers evaluated several adverse events including fever, allergy, and local reactions in mothers in the week following immunization, as well as preterm birth, low birth weight and small for gestational age in newborns. Local reactions included limb pain, limb swelling, cellulitis, lymphadenitis, and Arthus reaction. The researchers also looked for Guillain-Barré syndrome through day 42 after vaccination.

Few acute adverse events occurred after vaccination, and no statistically significant differences occurred across the three groups in terms of fever, allergic reactions, and local reactions.

Women who had received a tetanus-containing vaccine less than 2 years earlier had fevers at a rate of 2.1 per 10,000 women, compared with 3.5 per 10,000 women among controls (adjusted relative rate: 0.66; P = .70). Similarly, allergic reactions occurred at a rate of 2.1 per 10,000 women for those who had a vaccine less than 2 years prior, compared to 1 per 10,000 women who had the vaccine 2-5 years earlier, and 1.4 per 10,000 women among controls.

Local reactions occurred at a rate of 4.2, 7.0 and 11.2 per 10,000 women for those who had the vaccine less than 2 years prior, between 2-5 years prior, and more than 5 years prior, respectively. Preterm delivery rates, low birth weight, and small for gestation age were all similar across the three groups.

The Centers for Disease Control and Prevention and the National Institute of Allergy and Infectious Diseases funded the study. Dr. Sukumaran reported receiving research support from the National Institutes of Health. The other researchers reported receiving research support from GlaxoSmithKline, Sanofi Pasteur, Merck, Pfizer, Nuron Biotech, MedImmune, Novartis, and Protein Science.

Receiving the tetanus, diphtheria, acellular pertussis vaccine during pregnancy does not increase the risk of adverse events for mother or baby, even if the mother has previously received the vaccine within the past 2 years, according to a report published Oct. 20 in JAMA.

Women should receive a Tdap vaccination during each pregnancy – preferably in the third trimester – so that the fetus receives some maternal antibodies against pertussis for limited protection until the first DTaP vaccine at age 2 months, according to 2012 recommendation from the Advisory Committee on Immunization Practices (ACIP). Yet previous research has not clarified the safety of repeated doses of maternal Tdap immunization.

©AvailableLight/istockphoto.com

“These findings suggest that relatively recent receipt of a prior tetanus-containing vaccination does not increase risk after Tdap vaccination in pregnancy,” wrote Dr. Lakshmi Sukumaran of the Centers for Disease Control and Prevention Immunization Safety Office, and colleagues. “Our findings should reassure patients and clinicians who might be hesitant to give Tdap vaccine to pregnant women who recently received a Tdap or other tetanus-containing vaccination.”

In the retrospective cohort study involving pregnancies between Jan. 1, 2007, through Nov. 15, 2013, the researchers examined data from 29,155 pregnant women, aged 14-49, who enrolled in seven Vaccine Safety Datalink sites in California, Colorado, Minnesota, Oregon, Washington, and Wisconsin.

The researchers compared the 49% of women who had received a tetanus-containing vaccine more than 5 years before their current pregnancy (controls) with the 17% of women who had received a tetanus-containing vaccine less than 2 years before, and the 34% of women who had been vaccinated 2-5 years earlier. More than two-thirds of the women (67.4%) received the Tdap during the third trimester, compared with 27.5% in the second trimester, and 5.1% in the first trimester (JAMA. 2015;314[15]:1581-7. doi: 10.1001/jama.2015.12790).

The researchers evaluated several adverse events including fever, allergy, and local reactions in mothers in the week following immunization, as well as preterm birth, low birth weight and small for gestational age in newborns. Local reactions included limb pain, limb swelling, cellulitis, lymphadenitis, and Arthus reaction. The researchers also looked for Guillain-Barré syndrome through day 42 after vaccination.

Few acute adverse events occurred after vaccination, and no statistically significant differences occurred across the three groups in terms of fever, allergic reactions, and local reactions.

Women who had received a tetanus-containing vaccine less than 2 years earlier had fevers at a rate of 2.1 per 10,000 women, compared with 3.5 per 10,000 women among controls (adjusted relative rate: 0.66; P = .70). Similarly, allergic reactions occurred at a rate of 2.1 per 10,000 women for those who had a vaccine less than 2 years prior, compared to 1 per 10,000 women who had the vaccine 2-5 years earlier, and 1.4 per 10,000 women among controls.

Local reactions occurred at a rate of 4.2, 7.0 and 11.2 per 10,000 women for those who had the vaccine less than 2 years prior, between 2-5 years prior, and more than 5 years prior, respectively. Preterm delivery rates, low birth weight, and small for gestation age were all similar across the three groups.

The Centers for Disease Control and Prevention and the National Institute of Allergy and Infectious Diseases funded the study. Dr. Sukumaran reported receiving research support from the National Institutes of Health. The other researchers reported receiving research support from GlaxoSmithKline, Sanofi Pasteur, Merck, Pfizer, Nuron Biotech, MedImmune, Novartis, and Protein Science.

Receiving the tetanus, diphtheria, acellular pertussis vaccine during pregnancy does not increase the risk of adverse events for mother or baby, even if the mother has previously received the vaccine within the past 2 years, according to a report published Oct. 20 in JAMA.

Women should receive a Tdap vaccination during each pregnancy – preferably in the third trimester – so that the fetus receives some maternal antibodies against pertussis for limited protection until the first DTaP vaccine at age 2 months, according to 2012 recommendation from the Advisory Committee on Immunization Practices (ACIP). Yet previous research has not clarified the safety of repeated doses of maternal Tdap immunization.

©AvailableLight/istockphoto.com

“These findings suggest that relatively recent receipt of a prior tetanus-containing vaccination does not increase risk after Tdap vaccination in pregnancy,” wrote Dr. Lakshmi Sukumaran of the Centers for Disease Control and Prevention Immunization Safety Office, and colleagues. “Our findings should reassure patients and clinicians who might be hesitant to give Tdap vaccine to pregnant women who recently received a Tdap or other tetanus-containing vaccination.”

In the retrospective cohort study involving pregnancies between Jan. 1, 2007, through Nov. 15, 2013, the researchers examined data from 29,155 pregnant women, aged 14-49, who enrolled in seven Vaccine Safety Datalink sites in California, Colorado, Minnesota, Oregon, Washington, and Wisconsin.

The researchers compared the 49% of women who had received a tetanus-containing vaccine more than 5 years before their current pregnancy (controls) with the 17% of women who had received a tetanus-containing vaccine less than 2 years before, and the 34% of women who had been vaccinated 2-5 years earlier. More than two-thirds of the women (67.4%) received the Tdap during the third trimester, compared with 27.5% in the second trimester, and 5.1% in the first trimester (JAMA. 2015;314[15]:1581-7. doi: 10.1001/jama.2015.12790).

The researchers evaluated several adverse events including fever, allergy, and local reactions in mothers in the week following immunization, as well as preterm birth, low birth weight and small for gestational age in newborns. Local reactions included limb pain, limb swelling, cellulitis, lymphadenitis, and Arthus reaction. The researchers also looked for Guillain-Barré syndrome through day 42 after vaccination.

Few acute adverse events occurred after vaccination, and no statistically significant differences occurred across the three groups in terms of fever, allergic reactions, and local reactions.

Women who had received a tetanus-containing vaccine less than 2 years earlier had fevers at a rate of 2.1 per 10,000 women, compared with 3.5 per 10,000 women among controls (adjusted relative rate: 0.66; P = .70). Similarly, allergic reactions occurred at a rate of 2.1 per 10,000 women for those who had a vaccine less than 2 years prior, compared to 1 per 10,000 women who had the vaccine 2-5 years earlier, and 1.4 per 10,000 women among controls.

Local reactions occurred at a rate of 4.2, 7.0 and 11.2 per 10,000 women for those who had the vaccine less than 2 years prior, between 2-5 years prior, and more than 5 years prior, respectively. Preterm delivery rates, low birth weight, and small for gestation age were all similar across the three groups.

The Centers for Disease Control and Prevention and the National Institute of Allergy and Infectious Diseases funded the study. Dr. Sukumaran reported receiving research support from the National Institutes of Health. The other researchers reported receiving research support from GlaxoSmithKline, Sanofi Pasteur, Merck, Pfizer, Nuron Biotech, MedImmune, Novartis, and Protein Science.

COPENHAGEN – The nonsteroidal phosphodiesterase-4 inhibitor crisaborole aced all Food and Drug Administration–required efficacy and safety endpoints as a topical treatment for atopic dermatitis, according to results from a pair of pivotal phase III randomized trials.

“This is a fairly rapidly effective treatment,” explained Dr. Mark G. Lebwohl, who presented the findings at the annual congress of the European Academy of Dermatology and Venereology. “It has a favorable safety profile and has been studied in patients as young as 2 years of age. It may represent a new, safe, and efficacious treatment for patients 2 years of age and older with mild to moderate atopic dermatitis.”

Atopic dermatitis (AD) experts have long complained of a major unmet need for new, safe, and effective topical agents for AD, a condition that affects an estimated 18%-20% of children and 2%-10% of adults. Current treatment options all have drawbacks.

Topical steroids, long a treatment mainstay, are viewed by many parents with phobic mistrust of safety. And both FDA-approved topical calcineurin inhibitors carry black box warnings of possible cancer risk.

The two pivotal phase III studies, identical in design, included a total of 1,522 patients aged 2 years through adulthood with mild to moderate AD. Roughly 60% of patients had moderate disease, as defined by an Investigator’s Static Global Assessment (ISGA) score of 3 on a 0-4 scale; the other 40% had mild AD. The mean involved body surface area was 18%.

Participants were randomized two to one to crisaborole ointment 2% b.i.d. or vehicle for 28 days. Physicians assessed patients at baseline on day 1 of the study and again on days 8, 15, 22, 29, and 36. The primary endpoint was the proportion of patients on day 29 who had an ISGA of 0 or 1 – clear or almost clear – as well as at least a 2-point improvement from baseline on that scale.

In one of the trials, that endpoint was achieved in 32.8% of the crisaborole group, compared with 25.4% of controls.

“That 25% placebo response is actually fairly typical for atopic dermatitis studies,” according to Dr. Lebwohl, professor and chairman of the department of dermatology at Mount Sinai School of Medicine, New York.

In the other study, 31.4% of the crisaborole group and 18% of controls achieved the primary endpoint. In both studies, the difference was statistically significant in favor of topical crisaborole.

There were two prespecified secondary endpoints. One was time to treatment success, as defined by clear or almost clear. A “striking” significant difference between the study arms appeared as early as the first assessment, just 1 week into the trial, Dr. Lebwohl observed.

The other secondary endpoint was the FDA’s former efficacy standard, which required being clear or almost clear without the additional need for at least a 2-point ISGA improvement. That endpoint was achieved by 51.7% and 48.5% of crisaborole-treated patients in the two studies, compared with 40.6% and 29.7% of controls. Again, both differences were statistically significant.

No treatment-related serious adverse events occurred in either study. Mild application-site pain was slightly more common in the crisaborole-treated patients. But the rate of study discontinuations because of adverse events was identical between the crisaborole and control groups, at 1.2%. No differences in laboratory values, ECGs, or vital signs were noted between the two groups.

Dr. Lebwohl explained that boron is an essential element in crisaborole. The boron stimulates an increase in cyclic adenosine monophosphate levels, which in turn results in a steep reduction in production of inflammatory cytokines, including interleukins-4, -2, and -31, as well as tumor necrosis factor-alpha.

One audience member asked if it’s possible that crisaborole acts systemically rather than topically, given that patients averaged 18% body surface area involvement, and such a large area of damaged skin could conceivably allow the topical agent ready access to the circulation.

Dr. Lebwohl replied that systemic absorption of the drug was minor. “If you break down the results into patients with very low body surface areas – the lowest was 5% – those patients improved as well. So, I think it would be unlikely that this was a systemic effect.”

Anacor, which is developing the drug as a treatment for AD and other skin diseases, plans to file for marketing approval during the first half of 2016.

Anacor sponsored the two pivotal phase III randomized trials. Dr. Lebwohl declared having no financial conflicts of interest, because all funds went directly to the medical center in which he practices.

[email protected]

COPENHAGEN – The nonsteroidal phosphodiesterase-4 inhibitor crisaborole aced all Food and Drug Administration–required efficacy and safety endpoints as a topical treatment for atopic dermatitis, according to results from a pair of pivotal phase III randomized trials.

“This is a fairly rapidly effective treatment,” explained Dr. Mark G. Lebwohl, who presented the findings at the annual congress of the European Academy of Dermatology and Venereology. “It has a favorable safety profile and has been studied in patients as young as 2 years of age. It may represent a new, safe, and efficacious treatment for patients 2 years of age and older with mild to moderate atopic dermatitis.”

Atopic dermatitis (AD) experts have long complained of a major unmet need for new, safe, and effective topical agents for AD, a condition that affects an estimated 18%-20% of children and 2%-10% of adults. Current treatment options all have drawbacks.

Topical steroids, long a treatment mainstay, are viewed by many parents with phobic mistrust of safety. And both FDA-approved topical calcineurin inhibitors carry black box warnings of possible cancer risk.

The two pivotal phase III studies, identical in design, included a total of 1,522 patients aged 2 years through adulthood with mild to moderate AD. Roughly 60% of patients had moderate disease, as defined by an Investigator’s Static Global Assessment (ISGA) score of 3 on a 0-4 scale; the other 40% had mild AD. The mean involved body surface area was 18%.

Participants were randomized two to one to crisaborole ointment 2% b.i.d. or vehicle for 28 days. Physicians assessed patients at baseline on day 1 of the study and again on days 8, 15, 22, 29, and 36. The primary endpoint was the proportion of patients on day 29 who had an ISGA of 0 or 1 – clear or almost clear – as well as at least a 2-point improvement from baseline on that scale.

In one of the trials, that endpoint was achieved in 32.8% of the crisaborole group, compared with 25.4% of controls.

“That 25% placebo response is actually fairly typical for atopic dermatitis studies,” according to Dr. Lebwohl, professor and chairman of the department of dermatology at Mount Sinai School of Medicine, New York.

In the other study, 31.4% of the crisaborole group and 18% of controls achieved the primary endpoint. In both studies, the difference was statistically significant in favor of topical crisaborole.

There were two prespecified secondary endpoints. One was time to treatment success, as defined by clear or almost clear. A “striking” significant difference between the study arms appeared as early as the first assessment, just 1 week into the trial, Dr. Lebwohl observed.

The other secondary endpoint was the FDA’s former efficacy standard, which required being clear or almost clear without the additional need for at least a 2-point ISGA improvement. That endpoint was achieved by 51.7% and 48.5% of crisaborole-treated patients in the two studies, compared with 40.6% and 29.7% of controls. Again, both differences were statistically significant.

No treatment-related serious adverse events occurred in either study. Mild application-site pain was slightly more common in the crisaborole-treated patients. But the rate of study discontinuations because of adverse events was identical between the crisaborole and control groups, at 1.2%. No differences in laboratory values, ECGs, or vital signs were noted between the two groups.

Dr. Lebwohl explained that boron is an essential element in crisaborole. The boron stimulates an increase in cyclic adenosine monophosphate levels, which in turn results in a steep reduction in production of inflammatory cytokines, including interleukins-4, -2, and -31, as well as tumor necrosis factor-alpha.

One audience member asked if it’s possible that crisaborole acts systemically rather than topically, given that patients averaged 18% body surface area involvement, and such a large area of damaged skin could conceivably allow the topical agent ready access to the circulation.

Dr. Lebwohl replied that systemic absorption of the drug was minor. “If you break down the results into patients with very low body surface areas – the lowest was 5% – those patients improved as well. So, I think it would be unlikely that this was a systemic effect.”

Anacor, which is developing the drug as a treatment for AD and other skin diseases, plans to file for marketing approval during the first half of 2016.

Anacor sponsored the two pivotal phase III randomized trials. Dr. Lebwohl declared having no financial conflicts of interest, because all funds went directly to the medical center in which he practices.

[email protected]

COPENHAGEN – The nonsteroidal phosphodiesterase-4 inhibitor crisaborole aced all Food and Drug Administration–required efficacy and safety endpoints as a topical treatment for atopic dermatitis, according to results from a pair of pivotal phase III randomized trials.

“This is a fairly rapidly effective treatment,” explained Dr. Mark G. Lebwohl, who presented the findings at the annual congress of the European Academy of Dermatology and Venereology. “It has a favorable safety profile and has been studied in patients as young as 2 years of age. It may represent a new, safe, and efficacious treatment for patients 2 years of age and older with mild to moderate atopic dermatitis.”

Atopic dermatitis (AD) experts have long complained of a major unmet need for new, safe, and effective topical agents for AD, a condition that affects an estimated 18%-20% of children and 2%-10% of adults. Current treatment options all have drawbacks.

Topical steroids, long a treatment mainstay, are viewed by many parents with phobic mistrust of safety. And both FDA-approved topical calcineurin inhibitors carry black box warnings of possible cancer risk.

The two pivotal phase III studies, identical in design, included a total of 1,522 patients aged 2 years through adulthood with mild to moderate AD. Roughly 60% of patients had moderate disease, as defined by an Investigator’s Static Global Assessment (ISGA) score of 3 on a 0-4 scale; the other 40% had mild AD. The mean involved body surface area was 18%.

Participants were randomized two to one to crisaborole ointment 2% b.i.d. or vehicle for 28 days. Physicians assessed patients at baseline on day 1 of the study and again on days 8, 15, 22, 29, and 36. The primary endpoint was the proportion of patients on day 29 who had an ISGA of 0 or 1 – clear or almost clear – as well as at least a 2-point improvement from baseline on that scale.

In one of the trials, that endpoint was achieved in 32.8% of the crisaborole group, compared with 25.4% of controls.

“That 25% placebo response is actually fairly typical for atopic dermatitis studies,” according to Dr. Lebwohl, professor and chairman of the department of dermatology at Mount Sinai School of Medicine, New York.

In the other study, 31.4% of the crisaborole group and 18% of controls achieved the primary endpoint. In both studies, the difference was statistically significant in favor of topical crisaborole.

There were two prespecified secondary endpoints. One was time to treatment success, as defined by clear or almost clear. A “striking” significant difference between the study arms appeared as early as the first assessment, just 1 week into the trial, Dr. Lebwohl observed.

The other secondary endpoint was the FDA’s former efficacy standard, which required being clear or almost clear without the additional need for at least a 2-point ISGA improvement. That endpoint was achieved by 51.7% and 48.5% of crisaborole-treated patients in the two studies, compared with 40.6% and 29.7% of controls. Again, both differences were statistically significant.

No treatment-related serious adverse events occurred in either study. Mild application-site pain was slightly more common in the crisaborole-treated patients. But the rate of study discontinuations because of adverse events was identical between the crisaborole and control groups, at 1.2%. No differences in laboratory values, ECGs, or vital signs were noted between the two groups.

Dr. Lebwohl explained that boron is an essential element in crisaborole. The boron stimulates an increase in cyclic adenosine monophosphate levels, which in turn results in a steep reduction in production of inflammatory cytokines, including interleukins-4, -2, and -31, as well as tumor necrosis factor-alpha.

One audience member asked if it’s possible that crisaborole acts systemically rather than topically, given that patients averaged 18% body surface area involvement, and such a large area of damaged skin could conceivably allow the topical agent ready access to the circulation.

Dr. Lebwohl replied that systemic absorption of the drug was minor. “If you break down the results into patients with very low body surface areas – the lowest was 5% – those patients improved as well. So, I think it would be unlikely that this was a systemic effect.”

Anacor, which is developing the drug as a treatment for AD and other skin diseases, plans to file for marketing approval during the first half of 2016.

Anacor sponsored the two pivotal phase III randomized trials. Dr. Lebwohl declared having no financial conflicts of interest, because all funds went directly to the medical center in which he practices.

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ATLANTA – Mobile reminders from health care providers to their patients, notifying them to get influenza vaccinations, significantly increases the likelihood that those patients will get vaccinated, according to a study by Dr. Katherine A. Benedict and coinvestigators in the Enteric Diseases Epidemiology Branch at the Centers for Disease Control and Prevention. Dr. Benedict presented findings of the research at the International Conference on Emerging Infectious Diseases.

The researchers used data from the March 2012 National Flu Survey, a CDC “random digit dial telephone survey” of influenza vaccination trends in adults 18 years of age and older. They analyzed the data to determine whether or not patients received reminders, recommendations, or offers for influenza vaccinations from their health care providers since July 1, 2011. They did a logistic regression analysis to determine if there was any relationship between influenza vaccination rates and receipt of recommendations from health care providers.

©Eren Dündar/thinkstockphotos.com

Almost 73% of adults reported visiting a physician at least once since July 1, 2011, the start of data collection for the March 2012 study cycle, with 17.2% reporting that they received a reminder from their doctors to get a flu vaccine. Overall, 45.5% of adults ultimately got vaccinated, with 75.6% of those who reported receiving a reminder saying that they also were offered vaccinations by their doctors.

Adults who received recommendations for influenza vaccination from their health care providers were most likely to get vaccinated, and had an unadjusted prevalence ratio of 2.09. Next likely were those who received vaccination offers (PR = 1.90), and those who simply received reminders (PR = 1.33). Furthermore, those between 50 and 64 years old were found more likely to receive a recommendation or offer – PR = 1.23 and PR = 1.09, respectively – than were those in the 18- to 49-year age range (PR = 1.06 for recommendation, PR = 0.99 for offer).

The takeaway from this, according to the investigators, is that reminders should be sent at least once at the beginning of each influenza season. Prevalence ratios were consistently higher for patients with more frequent visits to their health care providers, meaning that continued interaction with and communication from doctors increases the likelihood of vaccination. Dr. Benedict also recommended sending additional reminders throughout the season, and that patients should either seek out or be referred to doctors who offer influenza vaccinations themselves.

Dr. Benedict did not report any relevant financial disclosures.

ATLANTA – Mobile reminders from health care providers to their patients, notifying them to get influenza vaccinations, significantly increases the likelihood that those patients will get vaccinated, according to a study by Dr. Katherine A. Benedict and coinvestigators in the Enteric Diseases Epidemiology Branch at the Centers for Disease Control and Prevention. Dr. Benedict presented findings of the research at the International Conference on Emerging Infectious Diseases.

The researchers used data from the March 2012 National Flu Survey, a CDC “random digit dial telephone survey” of influenza vaccination trends in adults 18 years of age and older. They analyzed the data to determine whether or not patients received reminders, recommendations, or offers for influenza vaccinations from their health care providers since July 1, 2011. They did a logistic regression analysis to determine if there was any relationship between influenza vaccination rates and receipt of recommendations from health care providers.

©Eren Dündar/thinkstockphotos.com

Almost 73% of adults reported visiting a physician at least once since July 1, 2011, the start of data collection for the March 2012 study cycle, with 17.2% reporting that they received a reminder from their doctors to get a flu vaccine. Overall, 45.5% of adults ultimately got vaccinated, with 75.6% of those who reported receiving a reminder saying that they also were offered vaccinations by their doctors.

Adults who received recommendations for influenza vaccination from their health care providers were most likely to get vaccinated, and had an unadjusted prevalence ratio of 2.09. Next likely were those who received vaccination offers (PR = 1.90), and those who simply received reminders (PR = 1.33). Furthermore, those between 50 and 64 years old were found more likely to receive a recommendation or offer – PR = 1.23 and PR = 1.09, respectively – than were those in the 18- to 49-year age range (PR = 1.06 for recommendation, PR = 0.99 for offer).

The takeaway from this, according to the investigators, is that reminders should be sent at least once at the beginning of each influenza season. Prevalence ratios were consistently higher for patients with more frequent visits to their health care providers, meaning that continued interaction with and communication from doctors increases the likelihood of vaccination. Dr. Benedict also recommended sending additional reminders throughout the season, and that patients should either seek out or be referred to doctors who offer influenza vaccinations themselves.

Dr. Benedict did not report any relevant financial disclosures.

ATLANTA – Mobile reminders from health care providers to their patients, notifying them to get influenza vaccinations, significantly increases the likelihood that those patients will get vaccinated, according to a study by Dr. Katherine A. Benedict and coinvestigators in the Enteric Diseases Epidemiology Branch at the Centers for Disease Control and Prevention. Dr. Benedict presented findings of the research at the International Conference on Emerging Infectious Diseases.

The researchers used data from the March 2012 National Flu Survey, a CDC “random digit dial telephone survey” of influenza vaccination trends in adults 18 years of age and older. They analyzed the data to determine whether or not patients received reminders, recommendations, or offers for influenza vaccinations from their health care providers since July 1, 2011. They did a logistic regression analysis to determine if there was any relationship between influenza vaccination rates and receipt of recommendations from health care providers.

©Eren Dündar/thinkstockphotos.com

Almost 73% of adults reported visiting a physician at least once since July 1, 2011, the start of data collection for the March 2012 study cycle, with 17.2% reporting that they received a reminder from their doctors to get a flu vaccine. Overall, 45.5% of adults ultimately got vaccinated, with 75.6% of those who reported receiving a reminder saying that they also were offered vaccinations by their doctors.

Adults who received recommendations for influenza vaccination from their health care providers were most likely to get vaccinated, and had an unadjusted prevalence ratio of 2.09. Next likely were those who received vaccination offers (PR = 1.90), and those who simply received reminders (PR = 1.33). Furthermore, those between 50 and 64 years old were found more likely to receive a recommendation or offer – PR = 1.23 and PR = 1.09, respectively – than were those in the 18- to 49-year age range (PR = 1.06 for recommendation, PR = 0.99 for offer).

The takeaway from this, according to the investigators, is that reminders should be sent at least once at the beginning of each influenza season. Prevalence ratios were consistently higher for patients with more frequent visits to their health care providers, meaning that continued interaction with and communication from doctors increases the likelihood of vaccination. Dr. Benedict also recommended sending additional reminders throughout the season, and that patients should either seek out or be referred to doctors who offer influenza vaccinations themselves.

Dr. Benedict did not report any relevant financial disclosures.