Pulmonary Health Hub

Using pimecrolimus cream as a first-line treatment for atopic dermatitis in infants spares the need for topical corticosteroids as frequently and appears safe over the long term, according to a study published online March 23 in Pediatrics.

“The efficacy results suggest that pimecrolimus has similar efficacy to topical corticosteroids in a real-world setting, which is noteworthy because pimecrolimus is not currently widely used as first-line therapy for atopic dermatitis, given the perception of lower efficacy than topical corticosteroids,” Dr. Bardur Sigurgeirsson of the University of Iceland, Reykjavik, and his associates said.

The researchers randomized 2,418 infants, between ages 3 and 12 months, to receive either pimecrolimus 1% cream, a noncorticosteroid topical calcineurin inhibitor that selectively suppresses activation of T cells and mast cells, or topical corticosteroids to treat mild to moderate atopic dermatitis affecting at least 5% of body surface area. The 1,205 infants receiving the pimecrolimus cream also received topical corticosteroids to treat short-term disease flares. Corticosteroids used were typically either 1% hydrocortisone or 0.1% hydrocortisone butyrate cream.

Success was defined as a 0 (clear) or 1 (mostly clear) on the Investigator’s Global Assessment scale, which ranges from 0 to 5.

More than half of the patients in both groups experienced cleared symptoms within the first three weeks (52.6% with pimecrolimus and 50.5% with corticosteroids). Five years later, among 1,710 patients still enrolled, 88.7% receiving pimecrolimus and 92.3% receiving corticosteroids had overall success. Facial treatment success was seen in 96.6% of infants in the pimecrolimus group and 97.2% of of those in the corticosteroids group, Dr. Sigurgeirsson and associates reported (Pediatrics 2015 March 23 [doi: 10.1542/peds.2014-1990]).

Those receiving pimecrolimus only required topical corticosteroids for a median 7 days, compared to 178 days in the corticosteroids group over the 5-year period. Just over a third (36%) of pimecrolimus patients never used topical corticosteroids.

Both groups experienced similar rates of adverse events, and neither showed negative effects on children’s humoral or cellular immunity, with similar antibody responses in both groups to routine vaccinations. Both groups also had similar growth rates, the investigators reported.

Using pimecrolimus cream as a first-line treatment for atopic dermatitis in infants spares the need for topical corticosteroids as frequently and appears safe over the long term, according to a study published online March 23 in Pediatrics.

“The efficacy results suggest that pimecrolimus has similar efficacy to topical corticosteroids in a real-world setting, which is noteworthy because pimecrolimus is not currently widely used as first-line therapy for atopic dermatitis, given the perception of lower efficacy than topical corticosteroids,” Dr. Bardur Sigurgeirsson of the University of Iceland, Reykjavik, and his associates said.

The researchers randomized 2,418 infants, between ages 3 and 12 months, to receive either pimecrolimus 1% cream, a noncorticosteroid topical calcineurin inhibitor that selectively suppresses activation of T cells and mast cells, or topical corticosteroids to treat mild to moderate atopic dermatitis affecting at least 5% of body surface area. The 1,205 infants receiving the pimecrolimus cream also received topical corticosteroids to treat short-term disease flares. Corticosteroids used were typically either 1% hydrocortisone or 0.1% hydrocortisone butyrate cream.

Success was defined as a 0 (clear) or 1 (mostly clear) on the Investigator’s Global Assessment scale, which ranges from 0 to 5.

More than half of the patients in both groups experienced cleared symptoms within the first three weeks (52.6% with pimecrolimus and 50.5% with corticosteroids). Five years later, among 1,710 patients still enrolled, 88.7% receiving pimecrolimus and 92.3% receiving corticosteroids had overall success. Facial treatment success was seen in 96.6% of infants in the pimecrolimus group and 97.2% of of those in the corticosteroids group, Dr. Sigurgeirsson and associates reported (Pediatrics 2015 March 23 [doi: 10.1542/peds.2014-1990]).

Those receiving pimecrolimus only required topical corticosteroids for a median 7 days, compared to 178 days in the corticosteroids group over the 5-year period. Just over a third (36%) of pimecrolimus patients never used topical corticosteroids.

Both groups experienced similar rates of adverse events, and neither showed negative effects on children’s humoral or cellular immunity, with similar antibody responses in both groups to routine vaccinations. Both groups also had similar growth rates, the investigators reported.

Using pimecrolimus cream as a first-line treatment for atopic dermatitis in infants spares the need for topical corticosteroids as frequently and appears safe over the long term, according to a study published online March 23 in Pediatrics.

“The efficacy results suggest that pimecrolimus has similar efficacy to topical corticosteroids in a real-world setting, which is noteworthy because pimecrolimus is not currently widely used as first-line therapy for atopic dermatitis, given the perception of lower efficacy than topical corticosteroids,” Dr. Bardur Sigurgeirsson of the University of Iceland, Reykjavik, and his associates said.

The researchers randomized 2,418 infants, between ages 3 and 12 months, to receive either pimecrolimus 1% cream, a noncorticosteroid topical calcineurin inhibitor that selectively suppresses activation of T cells and mast cells, or topical corticosteroids to treat mild to moderate atopic dermatitis affecting at least 5% of body surface area. The 1,205 infants receiving the pimecrolimus cream also received topical corticosteroids to treat short-term disease flares. Corticosteroids used were typically either 1% hydrocortisone or 0.1% hydrocortisone butyrate cream.

Success was defined as a 0 (clear) or 1 (mostly clear) on the Investigator’s Global Assessment scale, which ranges from 0 to 5.

More than half of the patients in both groups experienced cleared symptoms within the first three weeks (52.6% with pimecrolimus and 50.5% with corticosteroids). Five years later, among 1,710 patients still enrolled, 88.7% receiving pimecrolimus and 92.3% receiving corticosteroids had overall success. Facial treatment success was seen in 96.6% of infants in the pimecrolimus group and 97.2% of of those in the corticosteroids group, Dr. Sigurgeirsson and associates reported (Pediatrics 2015 March 23 [doi: 10.1542/peds.2014-1990]).

Those receiving pimecrolimus only required topical corticosteroids for a median 7 days, compared to 178 days in the corticosteroids group over the 5-year period. Just over a third (36%) of pimecrolimus patients never used topical corticosteroids.

Both groups experienced similar rates of adverse events, and neither showed negative effects on children’s humoral or cellular immunity, with similar antibody responses in both groups to routine vaccinations. Both groups also had similar growth rates, the investigators reported.

GAITHERSBURG, MD.– A Food and Drug Administration advisory panel supported approval of a fluticasone and vilanterol combination to treat asthma in adults – but the majority voted against approval for adolescents, citing a need for more safety and effectiveness data in that younger population.

GlaxoSmithKline has proposed that two fixed-dose combinations, 100 mcg or 200 mcg of the inhaled corticosteroid (ICS) fluticasone with 25 mcg of the long-acting beta-agonist (LABA) vilanterol in a dry powder inhaler, be approved for maintenance treatment of asthma in patients age 12 years and older, administered once per day.

The FDA approved the 100 mcg/25 mcg dose in 2013 to treat chronic obstructive pulmonary disease; GSK markets it as Breo Ellipta. To earn an asthma indication, the company submitted data from four studies, including a large safety study that addressed safety concerns associated with LABAs in the treatment of asthma.

At the March 19 joint meeting of the FDA’s Pulmonary-Allergy Drugs Advisory Committee and Drug Safety and Risk Management Advisory Committee, the panels voted 16-4 that the efficacy and safety data supported the approval of both proposed doses in adults.

Many panelists noted the benefit of having a once-daily inhaled treatment to treat asthma, which could improve compliance. Most agreed that the efficacy data in adults provided a substantial amount of evidence that the two doses had a “clinically meaningful benefit” in adults, with beneficial effects on lung function and exacerbation rates.

But the panelists voted 19-1 that the data did not support approval in adolescents, aged 12-17 years. Members expressed uncertainty about safety in that age group, which was studied in the same trials as adults.

In addition, study data indicated that the combination’s beneficial effects were no better than fluticasone alone, panelists said. They also noted a numerical imbalance in hospitalizations among adolescents in a large safety study, and they pointed to the availability of other treatments for that age group.

Panelists voting no also said the efficacy results in adolescents were inconsistent, with “no clear trends in the positive direction,” as one panelist noted. Furthermore, there was no evidence that the combination of fluticasone and vilanterol at either dose was more effective than the ICS alone on forced expiratory volume in 1 second or asthma exacerbations.

Panelists also cautioned that the positive results in adults, who made up the majority of patients enrolled in the studies, could not be extrapolated to adolescents. Thus, there was a need for a separate safety and efficacy study in adolescents.

“At least in the adults, it offers something, perhaps the additional benefit of better compliance,” said the panel chair, Dr. Erik Swenson, professor of medicine and physiology, pulmonary and critical care medicine, University of Washington, Seattle. The combination also was superior at both doses at improving lung function and reducing exacerbations.

But among patients age 12-17 years, “there seems to be no obvious superiority and possibly inferiority against just fluticasone alone,” Dr. Swenson said.

Considering that results of large, ongoing LABA safety trials may soon become available, “I don’t feel comfortable adding a new LABA to the mix right now,” said Dr. Judith Kramer, professor emerita of medicine, Duke University, Durham, N.C., who voted against approval both for pediatric and adult patients.

Because it is taken once a day, the combination’s main advantage would be adherence, Dr. Kramer added. But “it’s not adding any major new therapeutic benefit, and there is the safety concern in the adolescents, and there may well be off-label use.”

Given longstanding concerns about serious asthma-related events associated with LABAs – particularly in pediatric and black patients – the FDA has required manufacturers to conduct postmarketing safety studies evaluating the risks of LABAs when added to an ICS.

Those studies include a GSK study of more than 11,000 patients aged 12 years and older evaluating the safety of Advair, a combination of fluticasone and the LABA salmeterol. Results from that study could be available in early 2016.

For the fluticasone-vilanterol asthma indication, GSK submitted the results of two 12-week and one 24-week lung function studies, enrolling a total of about 2,200 patients whose mean age was 44 years (about 8% were aged 12-17 years).

Another study evaluated the time to first asthma exacerbation in more than 2,000 patients, which included almost 300 patients aged 12-17 years. In that study, the risk of asthma exacerbations was reduced by about 20% among those on the combination, compared with those on fluticasone alone. There were no intubations or deaths from asthma exacerbations.

But in a subgroup analysis of patients aged 12-17 years, conducted by the FDA, the risk of asthma exacerbations was higher among those treated with fluticasone-vilanterol, compared with patients 18 years and older.

In addition, an FDA meta-analysis of asthma-related serious adverse events in the four studies found a numerical imbalance in hospitalizations among adolescents: four hospitalizations among those on the combination drug, but none on fluticasone alone.

If approved, fluticasone-vilanterol would be the first once-daily inhaled ICS/LABA combination treatment for asthma. Fluticasone (100 mcg and 200 mcg) is approved for treating asthma. Unlike the LABAs salmeterol and formoterol, however, vilanterol is not approved for use as a single agent. Vilanterol (as part of the combination product) would be the first new LABA approved for asthma in 15 years.

The FDA usually follows the recommendations of its advisory panels; a decision is expected by April 30. Panelists had no disclosures.

[email protected]

GAITHERSBURG, MD.– A Food and Drug Administration advisory panel supported approval of a fluticasone and vilanterol combination to treat asthma in adults – but the majority voted against approval for adolescents, citing a need for more safety and effectiveness data in that younger population.

GlaxoSmithKline has proposed that two fixed-dose combinations, 100 mcg or 200 mcg of the inhaled corticosteroid (ICS) fluticasone with 25 mcg of the long-acting beta-agonist (LABA) vilanterol in a dry powder inhaler, be approved for maintenance treatment of asthma in patients age 12 years and older, administered once per day.

The FDA approved the 100 mcg/25 mcg dose in 2013 to treat chronic obstructive pulmonary disease; GSK markets it as Breo Ellipta. To earn an asthma indication, the company submitted data from four studies, including a large safety study that addressed safety concerns associated with LABAs in the treatment of asthma.

At the March 19 joint meeting of the FDA’s Pulmonary-Allergy Drugs Advisory Committee and Drug Safety and Risk Management Advisory Committee, the panels voted 16-4 that the efficacy and safety data supported the approval of both proposed doses in adults.

Many panelists noted the benefit of having a once-daily inhaled treatment to treat asthma, which could improve compliance. Most agreed that the efficacy data in adults provided a substantial amount of evidence that the two doses had a “clinically meaningful benefit” in adults, with beneficial effects on lung function and exacerbation rates.

But the panelists voted 19-1 that the data did not support approval in adolescents, aged 12-17 years. Members expressed uncertainty about safety in that age group, which was studied in the same trials as adults.

In addition, study data indicated that the combination’s beneficial effects were no better than fluticasone alone, panelists said. They also noted a numerical imbalance in hospitalizations among adolescents in a large safety study, and they pointed to the availability of other treatments for that age group.

Panelists voting no also said the efficacy results in adolescents were inconsistent, with “no clear trends in the positive direction,” as one panelist noted. Furthermore, there was no evidence that the combination of fluticasone and vilanterol at either dose was more effective than the ICS alone on forced expiratory volume in 1 second or asthma exacerbations.

Panelists also cautioned that the positive results in adults, who made up the majority of patients enrolled in the studies, could not be extrapolated to adolescents. Thus, there was a need for a separate safety and efficacy study in adolescents.

“At least in the adults, it offers something, perhaps the additional benefit of better compliance,” said the panel chair, Dr. Erik Swenson, professor of medicine and physiology, pulmonary and critical care medicine, University of Washington, Seattle. The combination also was superior at both doses at improving lung function and reducing exacerbations.

But among patients age 12-17 years, “there seems to be no obvious superiority and possibly inferiority against just fluticasone alone,” Dr. Swenson said.

Considering that results of large, ongoing LABA safety trials may soon become available, “I don’t feel comfortable adding a new LABA to the mix right now,” said Dr. Judith Kramer, professor emerita of medicine, Duke University, Durham, N.C., who voted against approval both for pediatric and adult patients.

Because it is taken once a day, the combination’s main advantage would be adherence, Dr. Kramer added. But “it’s not adding any major new therapeutic benefit, and there is the safety concern in the adolescents, and there may well be off-label use.”

Given longstanding concerns about serious asthma-related events associated with LABAs – particularly in pediatric and black patients – the FDA has required manufacturers to conduct postmarketing safety studies evaluating the risks of LABAs when added to an ICS.

Those studies include a GSK study of more than 11,000 patients aged 12 years and older evaluating the safety of Advair, a combination of fluticasone and the LABA salmeterol. Results from that study could be available in early 2016.

For the fluticasone-vilanterol asthma indication, GSK submitted the results of two 12-week and one 24-week lung function studies, enrolling a total of about 2,200 patients whose mean age was 44 years (about 8% were aged 12-17 years).

Another study evaluated the time to first asthma exacerbation in more than 2,000 patients, which included almost 300 patients aged 12-17 years. In that study, the risk of asthma exacerbations was reduced by about 20% among those on the combination, compared with those on fluticasone alone. There were no intubations or deaths from asthma exacerbations.

But in a subgroup analysis of patients aged 12-17 years, conducted by the FDA, the risk of asthma exacerbations was higher among those treated with fluticasone-vilanterol, compared with patients 18 years and older.

In addition, an FDA meta-analysis of asthma-related serious adverse events in the four studies found a numerical imbalance in hospitalizations among adolescents: four hospitalizations among those on the combination drug, but none on fluticasone alone.

If approved, fluticasone-vilanterol would be the first once-daily inhaled ICS/LABA combination treatment for asthma. Fluticasone (100 mcg and 200 mcg) is approved for treating asthma. Unlike the LABAs salmeterol and formoterol, however, vilanterol is not approved for use as a single agent. Vilanterol (as part of the combination product) would be the first new LABA approved for asthma in 15 years.

The FDA usually follows the recommendations of its advisory panels; a decision is expected by April 30. Panelists had no disclosures.

[email protected]

GAITHERSBURG, MD.– A Food and Drug Administration advisory panel supported approval of a fluticasone and vilanterol combination to treat asthma in adults – but the majority voted against approval for adolescents, citing a need for more safety and effectiveness data in that younger population.

GlaxoSmithKline has proposed that two fixed-dose combinations, 100 mcg or 200 mcg of the inhaled corticosteroid (ICS) fluticasone with 25 mcg of the long-acting beta-agonist (LABA) vilanterol in a dry powder inhaler, be approved for maintenance treatment of asthma in patients age 12 years and older, administered once per day.

The FDA approved the 100 mcg/25 mcg dose in 2013 to treat chronic obstructive pulmonary disease; GSK markets it as Breo Ellipta. To earn an asthma indication, the company submitted data from four studies, including a large safety study that addressed safety concerns associated with LABAs in the treatment of asthma.

At the March 19 joint meeting of the FDA’s Pulmonary-Allergy Drugs Advisory Committee and Drug Safety and Risk Management Advisory Committee, the panels voted 16-4 that the efficacy and safety data supported the approval of both proposed doses in adults.

Many panelists noted the benefit of having a once-daily inhaled treatment to treat asthma, which could improve compliance. Most agreed that the efficacy data in adults provided a substantial amount of evidence that the two doses had a “clinically meaningful benefit” in adults, with beneficial effects on lung function and exacerbation rates.

But the panelists voted 19-1 that the data did not support approval in adolescents, aged 12-17 years. Members expressed uncertainty about safety in that age group, which was studied in the same trials as adults.

In addition, study data indicated that the combination’s beneficial effects were no better than fluticasone alone, panelists said. They also noted a numerical imbalance in hospitalizations among adolescents in a large safety study, and they pointed to the availability of other treatments for that age group.

Panelists voting no also said the efficacy results in adolescents were inconsistent, with “no clear trends in the positive direction,” as one panelist noted. Furthermore, there was no evidence that the combination of fluticasone and vilanterol at either dose was more effective than the ICS alone on forced expiratory volume in 1 second or asthma exacerbations.

Panelists also cautioned that the positive results in adults, who made up the majority of patients enrolled in the studies, could not be extrapolated to adolescents. Thus, there was a need for a separate safety and efficacy study in adolescents.

“At least in the adults, it offers something, perhaps the additional benefit of better compliance,” said the panel chair, Dr. Erik Swenson, professor of medicine and physiology, pulmonary and critical care medicine, University of Washington, Seattle. The combination also was superior at both doses at improving lung function and reducing exacerbations.

But among patients age 12-17 years, “there seems to be no obvious superiority and possibly inferiority against just fluticasone alone,” Dr. Swenson said.

Considering that results of large, ongoing LABA safety trials may soon become available, “I don’t feel comfortable adding a new LABA to the mix right now,” said Dr. Judith Kramer, professor emerita of medicine, Duke University, Durham, N.C., who voted against approval both for pediatric and adult patients.

Because it is taken once a day, the combination’s main advantage would be adherence, Dr. Kramer added. But “it’s not adding any major new therapeutic benefit, and there is the safety concern in the adolescents, and there may well be off-label use.”

Given longstanding concerns about serious asthma-related events associated with LABAs – particularly in pediatric and black patients – the FDA has required manufacturers to conduct postmarketing safety studies evaluating the risks of LABAs when added to an ICS.

Those studies include a GSK study of more than 11,000 patients aged 12 years and older evaluating the safety of Advair, a combination of fluticasone and the LABA salmeterol. Results from that study could be available in early 2016.

For the fluticasone-vilanterol asthma indication, GSK submitted the results of two 12-week and one 24-week lung function studies, enrolling a total of about 2,200 patients whose mean age was 44 years (about 8% were aged 12-17 years).

Another study evaluated the time to first asthma exacerbation in more than 2,000 patients, which included almost 300 patients aged 12-17 years. In that study, the risk of asthma exacerbations was reduced by about 20% among those on the combination, compared with those on fluticasone alone. There were no intubations or deaths from asthma exacerbations.

But in a subgroup analysis of patients aged 12-17 years, conducted by the FDA, the risk of asthma exacerbations was higher among those treated with fluticasone-vilanterol, compared with patients 18 years and older.

In addition, an FDA meta-analysis of asthma-related serious adverse events in the four studies found a numerical imbalance in hospitalizations among adolescents: four hospitalizations among those on the combination drug, but none on fluticasone alone.

If approved, fluticasone-vilanterol would be the first once-daily inhaled ICS/LABA combination treatment for asthma. Fluticasone (100 mcg and 200 mcg) is approved for treating asthma. Unlike the LABAs salmeterol and formoterol, however, vilanterol is not approved for use as a single agent. Vilanterol (as part of the combination product) would be the first new LABA approved for asthma in 15 years.

The FDA usually follows the recommendations of its advisory panels; a decision is expected by April 30. Panelists had no disclosures.

[email protected]

HOUSTON – The higher prevalence of chronic urticaria in patients with self-reported penicillin allergy suggests that these patients may be confusing one condition with the other, according to a late-breaking study presented at the annual meeting of the American Academy of Allergy, Asthma, and Immunology.

A retrospective chart review of 1,419 patients with self-reported penicillin allergy revealed that 175 patients (12.3%) had a diagnosis of chronic urticaria, a significantly higher percentage than the typical prevalence range of 0.5%-5% that has been reported in the general population.

“Patients are potentially mistakenly attributing symptoms of chronic urticaria to a penicillin allergy,” explained study author Dr. Susanna G. Silverman of the University of Pennsylvania, Philadelphia.

The study included patients at the University of Pennsylvania’s allergy and immunology clinic who self-reported penicillin allergy from June 2007 to August 2014. Patients were identified as having penicillin allergy if penicillin, amoxicillin, amoxicillin-clavulanate, or piperacillin-tazobactam were present on the allergy list of their medical records.

Dr. Silverman then identified all patients from that group who also received a diagnosis of urticaria – a total of 343 patients – then narrowed the list to those who were diagnosed with chronic urticaria or the presence of urticaria for at least 6 weeks.

Of the 175 patients who had chronic urticaria, all were between the ages of 20 years and 92 years; 84% were female, and 53% were white.

“We think it’s important for physicians to think about this and to ask patients about symptoms of chronic urticaria when they report penicillin allergy,” Dr. Silverman noted, “to better determine what is truly penicillin allergy versus simply chronic urticaria symptoms.”

Dr. Silverman did not report any financial disclosures.

[email protected]

HOUSTON – The higher prevalence of chronic urticaria in patients with self-reported penicillin allergy suggests that these patients may be confusing one condition with the other, according to a late-breaking study presented at the annual meeting of the American Academy of Allergy, Asthma, and Immunology.

A retrospective chart review of 1,419 patients with self-reported penicillin allergy revealed that 175 patients (12.3%) had a diagnosis of chronic urticaria, a significantly higher percentage than the typical prevalence range of 0.5%-5% that has been reported in the general population.

“Patients are potentially mistakenly attributing symptoms of chronic urticaria to a penicillin allergy,” explained study author Dr. Susanna G. Silverman of the University of Pennsylvania, Philadelphia.

The study included patients at the University of Pennsylvania’s allergy and immunology clinic who self-reported penicillin allergy from June 2007 to August 2014. Patients were identified as having penicillin allergy if penicillin, amoxicillin, amoxicillin-clavulanate, or piperacillin-tazobactam were present on the allergy list of their medical records.

Dr. Silverman then identified all patients from that group who also received a diagnosis of urticaria – a total of 343 patients – then narrowed the list to those who were diagnosed with chronic urticaria or the presence of urticaria for at least 6 weeks.

Of the 175 patients who had chronic urticaria, all were between the ages of 20 years and 92 years; 84% were female, and 53% were white.

“We think it’s important for physicians to think about this and to ask patients about symptoms of chronic urticaria when they report penicillin allergy,” Dr. Silverman noted, “to better determine what is truly penicillin allergy versus simply chronic urticaria symptoms.”

Dr. Silverman did not report any financial disclosures.

[email protected]

HOUSTON – The higher prevalence of chronic urticaria in patients with self-reported penicillin allergy suggests that these patients may be confusing one condition with the other, according to a late-breaking study presented at the annual meeting of the American Academy of Allergy, Asthma, and Immunology.

A retrospective chart review of 1,419 patients with self-reported penicillin allergy revealed that 175 patients (12.3%) had a diagnosis of chronic urticaria, a significantly higher percentage than the typical prevalence range of 0.5%-5% that has been reported in the general population.

“Patients are potentially mistakenly attributing symptoms of chronic urticaria to a penicillin allergy,” explained study author Dr. Susanna G. Silverman of the University of Pennsylvania, Philadelphia.

The study included patients at the University of Pennsylvania’s allergy and immunology clinic who self-reported penicillin allergy from June 2007 to August 2014. Patients were identified as having penicillin allergy if penicillin, amoxicillin, amoxicillin-clavulanate, or piperacillin-tazobactam were present on the allergy list of their medical records.

Dr. Silverman then identified all patients from that group who also received a diagnosis of urticaria – a total of 343 patients – then narrowed the list to those who were diagnosed with chronic urticaria or the presence of urticaria for at least 6 weeks.

Of the 175 patients who had chronic urticaria, all were between the ages of 20 years and 92 years; 84% were female, and 53% were white.

“We think it’s important for physicians to think about this and to ask patients about symptoms of chronic urticaria when they report penicillin allergy,” Dr. Silverman noted, “to better determine what is truly penicillin allergy versus simply chronic urticaria symptoms.”

Dr. Silverman did not report any financial disclosures.

[email protected]

The 13-valent polysaccharide conjugate vaccine showed “significant efficacy” against vaccine-type strains of community-acquired pneumonia and vaccine-type invasive pneumococcal disease among the elderly in a large clinical trial in the Netherlands, according to a report published online March 19 in the New England Journal of Medicine.

The PCV13 vaccine’s efficacy in adults aged 65 years and older has never been determined until now. It became possible to assess efficacy in this age group when a serotype-specific urinary antigen detection assay was developed, which can identify Streptococcus pneumonia polysaccharides in the urine of patients suspected of having pneumonia rather than requiring isolation of the organism in culture, said Dr. Marc J. M. Bonten of Julius Center for Health Sciences and Primary Care, University Medical Center Utrecht (the Netherlands), and his associates.

lisafx/istockphoto.com

They used the assay to assess PCV13 efficacy in 84,496 older adults who were randomly assigned to receive active vaccine (42,240 participants) or placebo (42,256) and followed for a mean of 4 years in the trial, which was sponsored by Pfizer. In the per-protocol analysis, vaccine efficacy was 46% for preventing a first episode of vaccine-type community-acquired pneumonia, 45% for preventing nonbacteremic and noninvasive vaccine-type community-acquired pneumonia, and 75% for preventing vaccine-type invasive pneumococcal disease.

Evidence of the vaccine’s efficacy became apparent shortly after vaccination occurred and persisted throughout the duration of the study. There was no evidence of any safety concerns in the patients who received the active vaccine, wrote Dr. Bonten and his associates (N. Engl. J. Med. 2015 March 19 [doi:10.1056/NEJMoa1408544]).

The PCV13 vaccine did not show efficacy in preventing death from any cause, but the number of deaths associated with pneumococcal disease in this study was too small to allow a meaningful analysis of this outcome, the investigators noted.

The 13-valent polysaccharide conjugate vaccine showed “significant efficacy” against vaccine-type strains of community-acquired pneumonia and vaccine-type invasive pneumococcal disease among the elderly in a large clinical trial in the Netherlands, according to a report published online March 19 in the New England Journal of Medicine.

The PCV13 vaccine’s efficacy in adults aged 65 years and older has never been determined until now. It became possible to assess efficacy in this age group when a serotype-specific urinary antigen detection assay was developed, which can identify Streptococcus pneumonia polysaccharides in the urine of patients suspected of having pneumonia rather than requiring isolation of the organism in culture, said Dr. Marc J. M. Bonten of Julius Center for Health Sciences and Primary Care, University Medical Center Utrecht (the Netherlands), and his associates.

lisafx/istockphoto.com

They used the assay to assess PCV13 efficacy in 84,496 older adults who were randomly assigned to receive active vaccine (42,240 participants) or placebo (42,256) and followed for a mean of 4 years in the trial, which was sponsored by Pfizer. In the per-protocol analysis, vaccine efficacy was 46% for preventing a first episode of vaccine-type community-acquired pneumonia, 45% for preventing nonbacteremic and noninvasive vaccine-type community-acquired pneumonia, and 75% for preventing vaccine-type invasive pneumococcal disease.

Evidence of the vaccine’s efficacy became apparent shortly after vaccination occurred and persisted throughout the duration of the study. There was no evidence of any safety concerns in the patients who received the active vaccine, wrote Dr. Bonten and his associates (N. Engl. J. Med. 2015 March 19 [doi:10.1056/NEJMoa1408544]).

The PCV13 vaccine did not show efficacy in preventing death from any cause, but the number of deaths associated with pneumococcal disease in this study was too small to allow a meaningful analysis of this outcome, the investigators noted.

The 13-valent polysaccharide conjugate vaccine showed “significant efficacy” against vaccine-type strains of community-acquired pneumonia and vaccine-type invasive pneumococcal disease among the elderly in a large clinical trial in the Netherlands, according to a report published online March 19 in the New England Journal of Medicine.

The PCV13 vaccine’s efficacy in adults aged 65 years and older has never been determined until now. It became possible to assess efficacy in this age group when a serotype-specific urinary antigen detection assay was developed, which can identify Streptococcus pneumonia polysaccharides in the urine of patients suspected of having pneumonia rather than requiring isolation of the organism in culture, said Dr. Marc J. M. Bonten of Julius Center for Health Sciences and Primary Care, University Medical Center Utrecht (the Netherlands), and his associates.

lisafx/istockphoto.com

They used the assay to assess PCV13 efficacy in 84,496 older adults who were randomly assigned to receive active vaccine (42,240 participants) or placebo (42,256) and followed for a mean of 4 years in the trial, which was sponsored by Pfizer. In the per-protocol analysis, vaccine efficacy was 46% for preventing a first episode of vaccine-type community-acquired pneumonia, 45% for preventing nonbacteremic and noninvasive vaccine-type community-acquired pneumonia, and 75% for preventing vaccine-type invasive pneumococcal disease.

Evidence of the vaccine’s efficacy became apparent shortly after vaccination occurred and persisted throughout the duration of the study. There was no evidence of any safety concerns in the patients who received the active vaccine, wrote Dr. Bonten and his associates (N. Engl. J. Med. 2015 March 19 [doi:10.1056/NEJMoa1408544]).

The PCV13 vaccine did not show efficacy in preventing death from any cause, but the number of deaths associated with pneumococcal disease in this study was too small to allow a meaningful analysis of this outcome, the investigators noted.

The recent Ebola epidemic has demonstrated the need for better preparation for the possible emergence of an even more infectious disease, philanthropist and Microsoft cofounder Bill Gates wrote in a commentary in the New England Journal of Medicine.

The “problem,” Mr. Gates contended, was not the failure of one institution; instead, the Ebola epidemic represents a global failure on many levels. To effectively combat future epidemics, Mr. Gates, cochair of the Bill and Melinda Gates Foundation, Seattle, recommended building a global warning and response system that is coordinated by a global institution and has enough power and funding to work effectively. That system would expand research and development, improve early warning systems, employ a dedicated corps of volunteers, work to improve health systems in lower-income countries, and hold regular preparedness exercises.

“An epidemic is one of the few catastrophes that could set the world back drastically in the next few decades. By building a global warning and response system, we can prepare for it and prevent millions of deaths,” Mr. Gates concluded.

Read the full article in the New England Journal of Medicine (doi:10.1056/NEJMp1502918).

The recent Ebola epidemic has demonstrated the need for better preparation for the possible emergence of an even more infectious disease, philanthropist and Microsoft cofounder Bill Gates wrote in a commentary in the New England Journal of Medicine.

The “problem,” Mr. Gates contended, was not the failure of one institution; instead, the Ebola epidemic represents a global failure on many levels. To effectively combat future epidemics, Mr. Gates, cochair of the Bill and Melinda Gates Foundation, Seattle, recommended building a global warning and response system that is coordinated by a global institution and has enough power and funding to work effectively. That system would expand research and development, improve early warning systems, employ a dedicated corps of volunteers, work to improve health systems in lower-income countries, and hold regular preparedness exercises.

“An epidemic is one of the few catastrophes that could set the world back drastically in the next few decades. By building a global warning and response system, we can prepare for it and prevent millions of deaths,” Mr. Gates concluded.

Read the full article in the New England Journal of Medicine (doi:10.1056/NEJMp1502918).

The recent Ebola epidemic has demonstrated the need for better preparation for the possible emergence of an even more infectious disease, philanthropist and Microsoft cofounder Bill Gates wrote in a commentary in the New England Journal of Medicine.

The “problem,” Mr. Gates contended, was not the failure of one institution; instead, the Ebola epidemic represents a global failure on many levels. To effectively combat future epidemics, Mr. Gates, cochair of the Bill and Melinda Gates Foundation, Seattle, recommended building a global warning and response system that is coordinated by a global institution and has enough power and funding to work effectively. That system would expand research and development, improve early warning systems, employ a dedicated corps of volunteers, work to improve health systems in lower-income countries, and hold regular preparedness exercises.

“An epidemic is one of the few catastrophes that could set the world back drastically in the next few decades. By building a global warning and response system, we can prepare for it and prevent millions of deaths,” Mr. Gates concluded.

Read the full article in the New England Journal of Medicine (doi:10.1056/NEJMp1502918).

A new approach to screening has improved detection of tuberculosis among people applying to move to the United States, according to a report published online March 17 in Annals of Internal Medicine.

The previous preimmigration screening process involved chest radiography and, for those with abnormal radiographs, acid-fast bacilli smears of three consecutive sputum samples. If at least one smear was positive, the patient completed TB treatment overseas and was followed up after arrival in the United States. This approach failed, however, to detect some latent cases of TB that became reactivated soon after immigrants arrived in the United States.

Photo Credit: Janice Carr, Centers for Disease Control and Prevention

The new screening process also includes Mycobacterium tuberculosis culture results. For those who have at least one positive sputum smear or culture result, drug-susceptibility testing is performed and directly observed therapy for TB is typically completed overseas before U.S. relocation is allowed, Yecai Liu, a mathematical statistician with the division of global migration and quarantine, Centers for Disease Control and Prevention, and his associates said.

To assess the effectiveness of the new screening algorithm, the researchers analyzed information in the CDC’s disease notification database and the Department of Homeland Security’s immigration records regarding 3,212,421 immigrants and refugees who were screened overseas and arrived in the U.S. during a 7-year period. A total of 51.4% were screened by the old method and 48.6% by the new method.

Before the new screen was implemented, the annual number of smear-negative TB cases among newly arrived immigrants and refugees was relatively constant, at approximately 1,500/year. That number dropped to 940 cases/year after the new screening method was implemented. At the same time, the number of smear-negative but culture-positive TB cases diagnosed overseas among people bound for the U.S. increased from 4 to 629 cases per year.

Thus, the cumulative decline in U.S. cases during the study period was similar to the cumulative total of cases detected before relocation, the investigators said (Ann. Intern. Med. 2015 March 17 [doi:10.7326/M14-2082]).

The findings indicate the new culture-based TB screening is superior to smear-based TB screening and is “a high-yield intervention for preventing TB in immigrants and refugees bound for the United States.” Expanding such screening to cover exchange students, other exchange visitors, and temporary workers from countries with a high incidence of TB might further reduce the rate of the disease in foreign-born populations, the researchers concluded.

A new approach to screening has improved detection of tuberculosis among people applying to move to the United States, according to a report published online March 17 in Annals of Internal Medicine.

The previous preimmigration screening process involved chest radiography and, for those with abnormal radiographs, acid-fast bacilli smears of three consecutive sputum samples. If at least one smear was positive, the patient completed TB treatment overseas and was followed up after arrival in the United States. This approach failed, however, to detect some latent cases of TB that became reactivated soon after immigrants arrived in the United States.

Photo Credit: Janice Carr, Centers for Disease Control and Prevention

The new screening process also includes Mycobacterium tuberculosis culture results. For those who have at least one positive sputum smear or culture result, drug-susceptibility testing is performed and directly observed therapy for TB is typically completed overseas before U.S. relocation is allowed, Yecai Liu, a mathematical statistician with the division of global migration and quarantine, Centers for Disease Control and Prevention, and his associates said.

To assess the effectiveness of the new screening algorithm, the researchers analyzed information in the CDC’s disease notification database and the Department of Homeland Security’s immigration records regarding 3,212,421 immigrants and refugees who were screened overseas and arrived in the U.S. during a 7-year period. A total of 51.4% were screened by the old method and 48.6% by the new method.

Before the new screen was implemented, the annual number of smear-negative TB cases among newly arrived immigrants and refugees was relatively constant, at approximately 1,500/year. That number dropped to 940 cases/year after the new screening method was implemented. At the same time, the number of smear-negative but culture-positive TB cases diagnosed overseas among people bound for the U.S. increased from 4 to 629 cases per year.

Thus, the cumulative decline in U.S. cases during the study period was similar to the cumulative total of cases detected before relocation, the investigators said (Ann. Intern. Med. 2015 March 17 [doi:10.7326/M14-2082]).

The findings indicate the new culture-based TB screening is superior to smear-based TB screening and is “a high-yield intervention for preventing TB in immigrants and refugees bound for the United States.” Expanding such screening to cover exchange students, other exchange visitors, and temporary workers from countries with a high incidence of TB might further reduce the rate of the disease in foreign-born populations, the researchers concluded.

A new approach to screening has improved detection of tuberculosis among people applying to move to the United States, according to a report published online March 17 in Annals of Internal Medicine.

The previous preimmigration screening process involved chest radiography and, for those with abnormal radiographs, acid-fast bacilli smears of three consecutive sputum samples. If at least one smear was positive, the patient completed TB treatment overseas and was followed up after arrival in the United States. This approach failed, however, to detect some latent cases of TB that became reactivated soon after immigrants arrived in the United States.

Photo Credit: Janice Carr, Centers for Disease Control and Prevention

The new screening process also includes Mycobacterium tuberculosis culture results. For those who have at least one positive sputum smear or culture result, drug-susceptibility testing is performed and directly observed therapy for TB is typically completed overseas before U.S. relocation is allowed, Yecai Liu, a mathematical statistician with the division of global migration and quarantine, Centers for Disease Control and Prevention, and his associates said.

To assess the effectiveness of the new screening algorithm, the researchers analyzed information in the CDC’s disease notification database and the Department of Homeland Security’s immigration records regarding 3,212,421 immigrants and refugees who were screened overseas and arrived in the U.S. during a 7-year period. A total of 51.4% were screened by the old method and 48.6% by the new method.

Before the new screen was implemented, the annual number of smear-negative TB cases among newly arrived immigrants and refugees was relatively constant, at approximately 1,500/year. That number dropped to 940 cases/year after the new screening method was implemented. At the same time, the number of smear-negative but culture-positive TB cases diagnosed overseas among people bound for the U.S. increased from 4 to 629 cases per year.

Thus, the cumulative decline in U.S. cases during the study period was similar to the cumulative total of cases detected before relocation, the investigators said (Ann. Intern. Med. 2015 March 17 [doi:10.7326/M14-2082]).

The findings indicate the new culture-based TB screening is superior to smear-based TB screening and is “a high-yield intervention for preventing TB in immigrants and refugees bound for the United States.” Expanding such screening to cover exchange students, other exchange visitors, and temporary workers from countries with a high incidence of TB might further reduce the rate of the disease in foreign-born populations, the researchers concluded.

Administering continuous positive airway pressure to children for acute respiratory failure with a helmet leads to lower treatment failure rates and fewer air leaks and skin sores than does using a face mask, a recent study found.

“These results suggest that helmet CPAP was better tolerated than facial mask CPAP, with less need for sedation,” reported Dr. Giovanna Chidini of Ospedale Maggiore Policlinico, Milan, and her associates. “Its application in mild pediatric acute respiratory failure is feasible and free from adverse events, thus allowing longer treatment than with the mask” (Pediatrics 2015 March 16 [doi: 10.1542/peds.2014-1142]).

The authors randomly assigned 30 infants, all experiencing mild acute respiratory failure resulting from respiratory syncytial virus (RSV), to receive CPAP from a helmet or from a face mask. Treatment failure occurred in 17% (3 of 17 infants) of those using the helmet CPAP but in 54% (7 of 13) of those receiving CPAP with a face mask, primarily because of intolerance (P = .009). Infants who did not tolerate the face mask did successfully tolerate the helmet after being switched.

All the infants receiving face mask CPAP required sedation, compared with 35% of those receiving helmet CPAP (P = .02), and more air leaks and skin sores occurred in the face mask group, despite use of protective pads. Gas exchange and breathing patterns improved equally with both CPAP methods, but all infants required intubation within the first 24 hours because of worsening gas exchange.

No major adverse events, including cardiac arrest, pneumothorax, or safety system failures, occurred in either group. Number of days on CPAP and the CPAP application time in the first 24 hours were similar across both groups. Length of stay in the pediatric intensive care unit did not significantly differ between the two groups, and no gastric distension, eye irritation, or mortality occurred in either group.

“The pediatric helmet was introduced in clinical practice to increase the infant’s comfort while on CPAP,” Dr. Chidini and her associates wrote. “The helmet is supposed to have several advantages over nasal or whole-face masks: it allows free movement of the infant’s head as well as a good interaction with the environment while maintaining a good seal without compression.” No standardized measure of comfort has yet been established, however.

The study did not receive external funding, and the authors reported no disclosures.

Administering continuous positive airway pressure to children for acute respiratory failure with a helmet leads to lower treatment failure rates and fewer air leaks and skin sores than does using a face mask, a recent study found.

“These results suggest that helmet CPAP was better tolerated than facial mask CPAP, with less need for sedation,” reported Dr. Giovanna Chidini of Ospedale Maggiore Policlinico, Milan, and her associates. “Its application in mild pediatric acute respiratory failure is feasible and free from adverse events, thus allowing longer treatment than with the mask” (Pediatrics 2015 March 16 [doi: 10.1542/peds.2014-1142]).

The authors randomly assigned 30 infants, all experiencing mild acute respiratory failure resulting from respiratory syncytial virus (RSV), to receive CPAP from a helmet or from a face mask. Treatment failure occurred in 17% (3 of 17 infants) of those using the helmet CPAP but in 54% (7 of 13) of those receiving CPAP with a face mask, primarily because of intolerance (P = .009). Infants who did not tolerate the face mask did successfully tolerate the helmet after being switched.

All the infants receiving face mask CPAP required sedation, compared with 35% of those receiving helmet CPAP (P = .02), and more air leaks and skin sores occurred in the face mask group, despite use of protective pads. Gas exchange and breathing patterns improved equally with both CPAP methods, but all infants required intubation within the first 24 hours because of worsening gas exchange.

No major adverse events, including cardiac arrest, pneumothorax, or safety system failures, occurred in either group. Number of days on CPAP and the CPAP application time in the first 24 hours were similar across both groups. Length of stay in the pediatric intensive care unit did not significantly differ between the two groups, and no gastric distension, eye irritation, or mortality occurred in either group.

“The pediatric helmet was introduced in clinical practice to increase the infant’s comfort while on CPAP,” Dr. Chidini and her associates wrote. “The helmet is supposed to have several advantages over nasal or whole-face masks: it allows free movement of the infant’s head as well as a good interaction with the environment while maintaining a good seal without compression.” No standardized measure of comfort has yet been established, however.

The study did not receive external funding, and the authors reported no disclosures.

Administering continuous positive airway pressure to children for acute respiratory failure with a helmet leads to lower treatment failure rates and fewer air leaks and skin sores than does using a face mask, a recent study found.

“These results suggest that helmet CPAP was better tolerated than facial mask CPAP, with less need for sedation,” reported Dr. Giovanna Chidini of Ospedale Maggiore Policlinico, Milan, and her associates. “Its application in mild pediatric acute respiratory failure is feasible and free from adverse events, thus allowing longer treatment than with the mask” (Pediatrics 2015 March 16 [doi: 10.1542/peds.2014-1142]).

The authors randomly assigned 30 infants, all experiencing mild acute respiratory failure resulting from respiratory syncytial virus (RSV), to receive CPAP from a helmet or from a face mask. Treatment failure occurred in 17% (3 of 17 infants) of those using the helmet CPAP but in 54% (7 of 13) of those receiving CPAP with a face mask, primarily because of intolerance (P = .009). Infants who did not tolerate the face mask did successfully tolerate the helmet after being switched.

All the infants receiving face mask CPAP required sedation, compared with 35% of those receiving helmet CPAP (P = .02), and more air leaks and skin sores occurred in the face mask group, despite use of protective pads. Gas exchange and breathing patterns improved equally with both CPAP methods, but all infants required intubation within the first 24 hours because of worsening gas exchange.

No major adverse events, including cardiac arrest, pneumothorax, or safety system failures, occurred in either group. Number of days on CPAP and the CPAP application time in the first 24 hours were similar across both groups. Length of stay in the pediatric intensive care unit did not significantly differ between the two groups, and no gastric distension, eye irritation, or mortality occurred in either group.

“The pediatric helmet was introduced in clinical practice to increase the infant’s comfort while on CPAP,” Dr. Chidini and her associates wrote. “The helmet is supposed to have several advantages over nasal or whole-face masks: it allows free movement of the infant’s head as well as a good interaction with the environment while maintaining a good seal without compression.” No standardized measure of comfort has yet been established, however.

The study did not receive external funding, and the authors reported no disclosures.

Preterm infants responded less robustly to the 13-valent pneumococcal conjugate vaccine following the three-shot infant series compared with term infants, but they caught up following the 12-month booster dose, a recent study found.

“Although the immune response to PCV13 1 month after the infant series was lower in preterm infants versus term infants, it is likely to provide adequate protection against disease,” reported Dr. Federico Martinón-Torres of Hospital Clinico Universitario de Santiago de Compostela and the Healthcare Research Institute of Santiago in Spain. Preterm infants, especially those born before 32 weeks, are at higher risk for invasive pneumococcal disease. “These results reinforce the importance of timely pneumococcal vaccination for all infants, including those born prematurely,” wrote Dr.  Martinón-Torres and his associates (Pediatrics 2015 March 16 [doi: 10.1542/peds.2014-2941]).

Steve Mann_ThinkStock

The researchers enrolled 100 healthy term and 100 healthy preterm infants, aged 42-98 days, in a parallel-group study in which the children received the standard PCV13 series at ages 2, 3, and 4 months, followed by the booster dose at 12 months. The children also received all other childhood recommended vaccines (DTaP, hepatitis B vaccine, inactivated poliovirus vaccine, Haemophilus influenzae type b vaccine, and meningococcal group C conjugate vaccine).

The World Health Organization’s established protection threshold for PCV13 response is an IgG concentration of 0.35 mcg/mL or greater. One month after the third dose, at least 85% of the infants achieved this IgG threshold, but a smaller proportion of preterm infants than term infants reached this threshold for serotypes 5, 6A, and 6B. Response for serotypes 6A and 6B generally decreased along with gestational age. Overall titers were generally higher for infants born between 32 and 37 weeks’ gestation compared with those born before 32 weeks’ gestation.

One month after the toddler dose, however, more than 97% of term and preterm infants achieved at least 0.35 mcg/mL of IgG antibodies for all serotypes except serotype 3, for which response was lower with younger gestational age. “Differences in IgG response between preterm and term infants almost disappeared after toddler vaccination, emphasizing the importance of timely administration of the booster dose,” the authors wrote.

Local reactions were similar across both infant groups and decreased with each subsequent dose. Decreased appetite, irritability, or decreased sleep occurred slightly more often among preterm infants than among term infants. Most reactions were mild or moderate, with fewer than 10% overall experiencing a severe reaction and only one (term) infant experiencing a fever above 40ºC following the toddler dose. One preterm infant also experienced a vaccine-related rash. Overall, 14% preterm infant and 5% of term infants experienced serious adverse events, primarily infections, not necessarily vaccine-related.

The study was funded by Pfizer. Dr. Martinón-Torres and several other investigators reported ties to GlaxoSmithKline, Sanofi Pasteur MSD, Sanofi Pasteur, Pfizer/Wyeth, Novartis, MedImmune, and/or Baxter. The remaining investigators, except for Dr. Concheiro-Guisán who reported no disclosures, are Pfizer employees and stockholders.

Preterm infants responded less robustly to the 13-valent pneumococcal conjugate vaccine following the three-shot infant series compared with term infants, but they caught up following the 12-month booster dose, a recent study found.

“Although the immune response to PCV13 1 month after the infant series was lower in preterm infants versus term infants, it is likely to provide adequate protection against disease,” reported Dr. Federico Martinón-Torres of Hospital Clinico Universitario de Santiago de Compostela and the Healthcare Research Institute of Santiago in Spain. Preterm infants, especially those born before 32 weeks, are at higher risk for invasive pneumococcal disease. “These results reinforce the importance of timely pneumococcal vaccination for all infants, including those born prematurely,” wrote Dr.  Martinón-Torres and his associates (Pediatrics 2015 March 16 [doi: 10.1542/peds.2014-2941]).

Steve Mann_ThinkStock

The researchers enrolled 100 healthy term and 100 healthy preterm infants, aged 42-98 days, in a parallel-group study in which the children received the standard PCV13 series at ages 2, 3, and 4 months, followed by the booster dose at 12 months. The children also received all other childhood recommended vaccines (DTaP, hepatitis B vaccine, inactivated poliovirus vaccine, Haemophilus influenzae type b vaccine, and meningococcal group C conjugate vaccine).

The World Health Organization’s established protection threshold for PCV13 response is an IgG concentration of 0.35 mcg/mL or greater. One month after the third dose, at least 85% of the infants achieved this IgG threshold, but a smaller proportion of preterm infants than term infants reached this threshold for serotypes 5, 6A, and 6B. Response for serotypes 6A and 6B generally decreased along with gestational age. Overall titers were generally higher for infants born between 32 and 37 weeks’ gestation compared with those born before 32 weeks’ gestation.

One month after the toddler dose, however, more than 97% of term and preterm infants achieved at least 0.35 mcg/mL of IgG antibodies for all serotypes except serotype 3, for which response was lower with younger gestational age. “Differences in IgG response between preterm and term infants almost disappeared after toddler vaccination, emphasizing the importance of timely administration of the booster dose,” the authors wrote.

Local reactions were similar across both infant groups and decreased with each subsequent dose. Decreased appetite, irritability, or decreased sleep occurred slightly more often among preterm infants than among term infants. Most reactions were mild or moderate, with fewer than 10% overall experiencing a severe reaction and only one (term) infant experiencing a fever above 40ºC following the toddler dose. One preterm infant also experienced a vaccine-related rash. Overall, 14% preterm infant and 5% of term infants experienced serious adverse events, primarily infections, not necessarily vaccine-related.

The study was funded by Pfizer. Dr. Martinón-Torres and several other investigators reported ties to GlaxoSmithKline, Sanofi Pasteur MSD, Sanofi Pasteur, Pfizer/Wyeth, Novartis, MedImmune, and/or Baxter. The remaining investigators, except for Dr. Concheiro-Guisán who reported no disclosures, are Pfizer employees and stockholders.

Preterm infants responded less robustly to the 13-valent pneumococcal conjugate vaccine following the three-shot infant series compared with term infants, but they caught up following the 12-month booster dose, a recent study found.

“Although the immune response to PCV13 1 month after the infant series was lower in preterm infants versus term infants, it is likely to provide adequate protection against disease,” reported Dr. Federico Martinón-Torres of Hospital Clinico Universitario de Santiago de Compostela and the Healthcare Research Institute of Santiago in Spain. Preterm infants, especially those born before 32 weeks, are at higher risk for invasive pneumococcal disease. “These results reinforce the importance of timely pneumococcal vaccination for all infants, including those born prematurely,” wrote Dr.  Martinón-Torres and his associates (Pediatrics 2015 March 16 [doi: 10.1542/peds.2014-2941]).

Steve Mann_ThinkStock

The researchers enrolled 100 healthy term and 100 healthy preterm infants, aged 42-98 days, in a parallel-group study in which the children received the standard PCV13 series at ages 2, 3, and 4 months, followed by the booster dose at 12 months. The children also received all other childhood recommended vaccines (DTaP, hepatitis B vaccine, inactivated poliovirus vaccine, Haemophilus influenzae type b vaccine, and meningococcal group C conjugate vaccine).

The World Health Organization’s established protection threshold for PCV13 response is an IgG concentration of 0.35 mcg/mL or greater. One month after the third dose, at least 85% of the infants achieved this IgG threshold, but a smaller proportion of preterm infants than term infants reached this threshold for serotypes 5, 6A, and 6B. Response for serotypes 6A and 6B generally decreased along with gestational age. Overall titers were generally higher for infants born between 32 and 37 weeks’ gestation compared with those born before 32 weeks’ gestation.

One month after the toddler dose, however, more than 97% of term and preterm infants achieved at least 0.35 mcg/mL of IgG antibodies for all serotypes except serotype 3, for which response was lower with younger gestational age. “Differences in IgG response between preterm and term infants almost disappeared after toddler vaccination, emphasizing the importance of timely administration of the booster dose,” the authors wrote.

Local reactions were similar across both infant groups and decreased with each subsequent dose. Decreased appetite, irritability, or decreased sleep occurred slightly more often among preterm infants than among term infants. Most reactions were mild or moderate, with fewer than 10% overall experiencing a severe reaction and only one (term) infant experiencing a fever above 40ºC following the toddler dose. One preterm infant also experienced a vaccine-related rash. Overall, 14% preterm infant and 5% of term infants experienced serious adverse events, primarily infections, not necessarily vaccine-related.

The study was funded by Pfizer. Dr. Martinón-Torres and several other investigators reported ties to GlaxoSmithKline, Sanofi Pasteur MSD, Sanofi Pasteur, Pfizer/Wyeth, Novartis, MedImmune, and/or Baxter. The remaining investigators, except for Dr. Concheiro-Guisán who reported no disclosures, are Pfizer employees and stockholders.