Atopic Dermatitis

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]

HOUSTON– Dr. Megan S. Motosue of the Mayo Clinic in Rochester, Minn., discusses the value of penicillin skin testing as a potent tool for improving inpatient antibiotic stewardship. By routinely performing penicillin skin testing using standard methods in a consecutive series of inpatients with a self-reported history of penicillin allergy, roughly 80% were found to not in fact be allergic. And this information changed their physicians’ behavior: prior to testing, vancomycin was the most commonly used antibiotic in the inpatients, but its use was reduced by more than half based upon the skin test results, with a commensurate increase in prescriptions for semi-synthetic penicillins.

[email protected]

HOUSTON– Dr. Megan S. Motosue of the Mayo Clinic in Rochester, Minn., discusses the value of penicillin skin testing as a potent tool for improving inpatient antibiotic stewardship. By routinely performing penicillin skin testing using standard methods in a consecutive series of inpatients with a self-reported history of penicillin allergy, roughly 80% were found to not in fact be allergic. And this information changed their physicians’ behavior: prior to testing, vancomycin was the most commonly used antibiotic in the inpatients, but its use was reduced by more than half based upon the skin test results, with a commensurate increase in prescriptions for semi-synthetic penicillins.

[email protected]

HOUSTON– Dr. Megan S. Motosue of the Mayo Clinic in Rochester, Minn., discusses the value of penicillin skin testing as a potent tool for improving inpatient antibiotic stewardship. By routinely performing penicillin skin testing using standard methods in a consecutive series of inpatients with a self-reported history of penicillin allergy, roughly 80% were found to not in fact be allergic. And this information changed their physicians’ behavior: prior to testing, vancomycin was the most commonly used antibiotic in the inpatients, but its use was reduced by more than half based upon the skin test results, with a commensurate increase in prescriptions for semi-synthetic penicillins.

[email protected]

HOUSTON – Whether atopic dermatitis should be treated with allergen immunotherapy is still a matter of debate, as high-quality trial evidence remains scant, but clinical practice is starting to recognize the potential use of subcutaneous and sublingual immunotherapy for certain presentations of the disease.

For patients with allergy to house-dust mites, evidence is leaning toward a role for subcutaneous immunotherapy (SCIT) in severe forms of atopic dermatitis (AD), and to sublingual immunotherapy (SLIT) for milder forms, researchers said.

At the annual meeting of the American Academy of Allergy, Asthma, and Immunotherapy, Dr. Linda Cox, an allergist in private practice in Fort Lauderdale, Fla., said that poor trial evidence and a lack of standardization in outcome measures have hindered a better understanding of when SLIT and SCIT might be indicated in atopic dermatitis. Systematic reviews have failed to offer compelling evidence for its efficacy.

This is why current practice guidelines, published in 2012, say only that clinicians “might consider” allergen immunotherapy in selected patients with AD with aeroallergen sensitivity, and the research community has been striving to standardize outcome measures using two published eczema scoring systems, EASI (Eczema Area and Severity Index) and SCORAD (Severity Scoring of Atopic Dermatitis). Dr. Cox, part of the AAAAI/American College of Asthma, Allergy, and Immunology joint task force on allergen immunotherapies, said new clinical guidelines in progress would likely attempt to better define the role of SLIT and SCIT in atopic dermatitis.

Dr. Cox and another speaker at the conference, Dr. Moises Calderon, both pointed to house-dust mite allergy with AD as the most promising indication for immunotherapy in AD. A closer look at the few well-designed trials that have been conducted so far reveal the potential for a better-defined role for SLIT and SCIT, they agreed.

Dr. Calderon of Imperial College London identified four important trials dealing with this issue. The first was a German study of adults with AD aggravated by house-dust mites (n = 168) randomized to SCID or placebo and treated for 18 months. The study revealed no statistically significant differences for the treatment group as a whole, but a subgroup of patients with severe AD showed a statistically significant reduction of SCORAD disease scores by 18% (P = .02), compared with placebo (J Allergy Clin Immunol. 2012;130:925-31).

An Italian trial enrolling house-dust mite–sensitive children with AD (n = 56, randomized 1:1 to treatment with SLIT or placebo) found a significant difference in SCORAD from baseline (P = .25) between the children treated with SLIT and the placebo group starting 9 months after treatment. However, the difference was seen in patients with mild or moderate disease only; minimal benefit was found for children with severe disease (J. Allergy Clin. Immunol. 2007;120:164-70).

Dr. Calderon pointed to two additional studies published that also suggested benefit. The first was an open-label Colombian study enrolling children and young adults (n = 60). Of the 31 patients randomized to treatment with SCIT and topical therapies (controls received only topical treatment), the treatment group had significant SCORAD-measured improvement, compared with the control group (P = .03). At 1 year the active group also used topical steroids and tacrolimus significantly less (P = .02), and also had a significant increase in mite-specific IgG4 (doi:10.5402/2012/183983).

Dr. Calderon also mentioned a recent observational study from Poland that looked at long-term follow-up of a group of 15 AD patients treated with SCIT between 1995 and 2001 and followed for 12 years. The results suggested that SCIT may be associated with lasting improvements even after treatment termination (Eur. Ann. Allergy Clin. Immunol. 2015;47:5-9).

Both Dr. Cox and Dr. Calderon agreed that more and better evidence was needed to understand when and how SLIT and SCIT can work in atopic dermatitis. “AD is a heterogeneous disease, and immunotherapy cannot be a treatment for all types of atopic dermatitis – no one treatment is probably effective for all types of AD,” Dr. Cox cautioned. But “the direction of therapy is headed toward some acceptance.”

Dr, Calderon concurred. “We are on the way to acceptance. But new studies will be key,” he said.

Dr. Cox disclosed financial relationships with Greer and Circassia. Dr. Calderon disclosed no conflicts of interest.

HOUSTON – Whether atopic dermatitis should be treated with allergen immunotherapy is still a matter of debate, as high-quality trial evidence remains scant, but clinical practice is starting to recognize the potential use of subcutaneous and sublingual immunotherapy for certain presentations of the disease.

For patients with allergy to house-dust mites, evidence is leaning toward a role for subcutaneous immunotherapy (SCIT) in severe forms of atopic dermatitis (AD), and to sublingual immunotherapy (SLIT) for milder forms, researchers said.

At the annual meeting of the American Academy of Allergy, Asthma, and Immunotherapy, Dr. Linda Cox, an allergist in private practice in Fort Lauderdale, Fla., said that poor trial evidence and a lack of standardization in outcome measures have hindered a better understanding of when SLIT and SCIT might be indicated in atopic dermatitis. Systematic reviews have failed to offer compelling evidence for its efficacy.

This is why current practice guidelines, published in 2012, say only that clinicians “might consider” allergen immunotherapy in selected patients with AD with aeroallergen sensitivity, and the research community has been striving to standardize outcome measures using two published eczema scoring systems, EASI (Eczema Area and Severity Index) and SCORAD (Severity Scoring of Atopic Dermatitis). Dr. Cox, part of the AAAAI/American College of Asthma, Allergy, and Immunology joint task force on allergen immunotherapies, said new clinical guidelines in progress would likely attempt to better define the role of SLIT and SCIT in atopic dermatitis.

Dr. Cox and another speaker at the conference, Dr. Moises Calderon, both pointed to house-dust mite allergy with AD as the most promising indication for immunotherapy in AD. A closer look at the few well-designed trials that have been conducted so far reveal the potential for a better-defined role for SLIT and SCIT, they agreed.

Dr. Calderon of Imperial College London identified four important trials dealing with this issue. The first was a German study of adults with AD aggravated by house-dust mites (n = 168) randomized to SCID or placebo and treated for 18 months. The study revealed no statistically significant differences for the treatment group as a whole, but a subgroup of patients with severe AD showed a statistically significant reduction of SCORAD disease scores by 18% (P = .02), compared with placebo (J Allergy Clin Immunol. 2012;130:925-31).

An Italian trial enrolling house-dust mite–sensitive children with AD (n = 56, randomized 1:1 to treatment with SLIT or placebo) found a significant difference in SCORAD from baseline (P = .25) between the children treated with SLIT and the placebo group starting 9 months after treatment. However, the difference was seen in patients with mild or moderate disease only; minimal benefit was found for children with severe disease (J. Allergy Clin. Immunol. 2007;120:164-70).

Dr. Calderon pointed to two additional studies published that also suggested benefit. The first was an open-label Colombian study enrolling children and young adults (n = 60). Of the 31 patients randomized to treatment with SCIT and topical therapies (controls received only topical treatment), the treatment group had significant SCORAD-measured improvement, compared with the control group (P = .03). At 1 year the active group also used topical steroids and tacrolimus significantly less (P = .02), and also had a significant increase in mite-specific IgG4 (doi:10.5402/2012/183983).

Dr. Calderon also mentioned a recent observational study from Poland that looked at long-term follow-up of a group of 15 AD patients treated with SCIT between 1995 and 2001 and followed for 12 years. The results suggested that SCIT may be associated with lasting improvements even after treatment termination (Eur. Ann. Allergy Clin. Immunol. 2015;47:5-9).

Both Dr. Cox and Dr. Calderon agreed that more and better evidence was needed to understand when and how SLIT and SCIT can work in atopic dermatitis. “AD is a heterogeneous disease, and immunotherapy cannot be a treatment for all types of atopic dermatitis – no one treatment is probably effective for all types of AD,” Dr. Cox cautioned. But “the direction of therapy is headed toward some acceptance.”

Dr, Calderon concurred. “We are on the way to acceptance. But new studies will be key,” he said.

Dr. Cox disclosed financial relationships with Greer and Circassia. Dr. Calderon disclosed no conflicts of interest.

HOUSTON – Whether atopic dermatitis should be treated with allergen immunotherapy is still a matter of debate, as high-quality trial evidence remains scant, but clinical practice is starting to recognize the potential use of subcutaneous and sublingual immunotherapy for certain presentations of the disease.

For patients with allergy to house-dust mites, evidence is leaning toward a role for subcutaneous immunotherapy (SCIT) in severe forms of atopic dermatitis (AD), and to sublingual immunotherapy (SLIT) for milder forms, researchers said.

At the annual meeting of the American Academy of Allergy, Asthma, and Immunotherapy, Dr. Linda Cox, an allergist in private practice in Fort Lauderdale, Fla., said that poor trial evidence and a lack of standardization in outcome measures have hindered a better understanding of when SLIT and SCIT might be indicated in atopic dermatitis. Systematic reviews have failed to offer compelling evidence for its efficacy.

This is why current practice guidelines, published in 2012, say only that clinicians “might consider” allergen immunotherapy in selected patients with AD with aeroallergen sensitivity, and the research community has been striving to standardize outcome measures using two published eczema scoring systems, EASI (Eczema Area and Severity Index) and SCORAD (Severity Scoring of Atopic Dermatitis). Dr. Cox, part of the AAAAI/American College of Asthma, Allergy, and Immunology joint task force on allergen immunotherapies, said new clinical guidelines in progress would likely attempt to better define the role of SLIT and SCIT in atopic dermatitis.

Dr. Cox and another speaker at the conference, Dr. Moises Calderon, both pointed to house-dust mite allergy with AD as the most promising indication for immunotherapy in AD. A closer look at the few well-designed trials that have been conducted so far reveal the potential for a better-defined role for SLIT and SCIT, they agreed.

Dr. Calderon of Imperial College London identified four important trials dealing with this issue. The first was a German study of adults with AD aggravated by house-dust mites (n = 168) randomized to SCID or placebo and treated for 18 months. The study revealed no statistically significant differences for the treatment group as a whole, but a subgroup of patients with severe AD showed a statistically significant reduction of SCORAD disease scores by 18% (P = .02), compared with placebo (J Allergy Clin Immunol. 2012;130:925-31).

An Italian trial enrolling house-dust mite–sensitive children with AD (n = 56, randomized 1:1 to treatment with SLIT or placebo) found a significant difference in SCORAD from baseline (P = .25) between the children treated with SLIT and the placebo group starting 9 months after treatment. However, the difference was seen in patients with mild or moderate disease only; minimal benefit was found for children with severe disease (J. Allergy Clin. Immunol. 2007;120:164-70).

Dr. Calderon pointed to two additional studies published that also suggested benefit. The first was an open-label Colombian study enrolling children and young adults (n = 60). Of the 31 patients randomized to treatment with SCIT and topical therapies (controls received only topical treatment), the treatment group had significant SCORAD-measured improvement, compared with the control group (P = .03). At 1 year the active group also used topical steroids and tacrolimus significantly less (P = .02), and also had a significant increase in mite-specific IgG4 (doi:10.5402/2012/183983).

Dr. Calderon also mentioned a recent observational study from Poland that looked at long-term follow-up of a group of 15 AD patients treated with SCIT between 1995 and 2001 and followed for 12 years. The results suggested that SCIT may be associated with lasting improvements even after treatment termination (Eur. Ann. Allergy Clin. Immunol. 2015;47:5-9).

Both Dr. Cox and Dr. Calderon agreed that more and better evidence was needed to understand when and how SLIT and SCIT can work in atopic dermatitis. “AD is a heterogeneous disease, and immunotherapy cannot be a treatment for all types of atopic dermatitis – no one treatment is probably effective for all types of AD,” Dr. Cox cautioned. But “the direction of therapy is headed toward some acceptance.”

Dr, Calderon concurred. “We are on the way to acceptance. But new studies will be key,” he said.

Dr. Cox disclosed financial relationships with Greer and Circassia. Dr. Calderon disclosed no conflicts of interest.

HOUSTON – Sublingual immunotherapy, or SLIT, long used by clinicians worldwide, is newly approved for use in the United States, and practice guidelines have yet to be published for U.S. clinicians.

A joint task force of the American Academy of Allergy, Asthma, and Immunology (AAAAI) and the American College of Allergy, Asthma, and Immunology (ACAAI) is drafting the guidelines. While clinicians wait, here is a look at the evidence for efficacy and safety of SLIT – particularly when compared with subcutaneous immunotherapy – as well as at the progress of the guidelines, offered by Dr. Linda Cox, an allergist in private practice in Fort Lauderdale, Fla. Dr. Cox spoke at the annual meeting of the AAAAI.

The guidelines will closely follow package labeling for the three sublingual pollen-allergy medications approved last year by the Food and Drug Administration, Dr. Cox said. These are the multipollen allergen tablet Oralair (Stallergenes), the Timothy grass pollen tablet Grastek (Merck), and the ragweed tablet Ragwitek (Merck). The medicines’ indications differ in terms of minimum age for prescription, ranging from 5 to 18 years, and the timing of treatment, with Grastek indicated as a year-round treatment, and the others as seasonal treatments.

FDA labeling on all three medications recommends coprescription of epinephrine pens in case of systemic reactions, and Dr. Cox said that the AAAAI/ACAAI guidelines would reflect this. Nonetheless, coprescription of epi pens “has never been the standard in Europe or other parts of the globe. We don’t have guidance from the broader community in terms of when to take the epinephrine in terms of a SLIT reaction,” she noted. Physicians should “be aware and think about what sort of instructions you’re going to give your patients” on the use of epi pens.

The guidelines in progress advise physicians to counsel patients that site application symptoms such as itching and swelling are very common during the first week of SLIT treatment, and that the majority of SLIT reactions are local (oral, pharyngeal, or abdominal). These local reactions usually disappear within days to weeks without treatment or dose modification, though some can be severe or bothersome enough to discontinue treatment. Systemic allergic reactions are very uncommon.

The guidelines are also likely to caution physicians that there are insufficient studies comparing SLIT and subcutaneous immunotherapy, or SCIT, to make a definitive statement about efficacy, Dr. Cox said. They will note that available studies suggest SCIT is more effective in the first year of treatment than SLIT, and comparative long-term efficacy studies have not been conducted, she added.

Finally, the guidelines are likely to caution that SLIT is contraindicated in patients who are not likely to survive a systemic adverse reaction or the resultant treatment.

Dr. Cox did not say when the guidelines were likely to be published, just that “we are frantically trying to get this document together,” noting the short time that SLIT has been commercially available in the United States.

At the same session on SLIT, Dr. Desiree Larenas Linneman, an allergist in private practice in Mexico City, spoke at the meeting about practical concerns related to SLIT and how to choose whether a patient is better suited to shots or sublingual therapy.

“When you bring sublingual to the public there are several issues you are going to have to be very careful with,” Dr. Larenas Linneman said. Among these are prescriptions of highly concentrated medications by nonallergists, adherence, and patient preference. “And we still do not have data for SLIT on a vast array of comorbidities,” she said.

“When we only had SCIT, these patients came into our offices and the only decision was, would we go for shots or not?” Now the choices are more complicated. A multiallergic 8-year-old, ordinarily a good candidate for SCIT, might be better treated with tablets if the parent is adamant that the child not get shots, she said. An adult who travels constantly for work might find tablets more convenient.

But for multiallergic and highly allergic patients, SCIT is generally the more flexible and reliable option, Dr. Larenas Linneman said. Allergists have access to a great variety of different allergens they can combine to make SCIT, while the approved tablets cover only pollen. And a tablet is a fixed dose, she said, “so there’s no adjustment for highly allergic patients.”

Dr. Larenas Linneman noted that adherence and patient preference are closely related, something that physicians must keep in mind when choosing the form of immunotherapy to offer. “Adherence is a very important issue because we know adherence is quite poor both with SLIT and SCIT,” she said.

“Physicians think that what’s most important for the patient is efficacy, cost, and side effects,” but patients’ ability to comply is also key, she said, and clinicians should let patient preference guide their decisions when possible.

Dr. Cox disclosed ongoing consulting relationships with Greer and Circassia. Dr. Larenas Linnemann disclosed financial support from AstraZeneca, Pfizer, Novartis, MEDA, Sanofi, and Senosiain.

HOUSTON – Sublingual immunotherapy, or SLIT, long used by clinicians worldwide, is newly approved for use in the United States, and practice guidelines have yet to be published for U.S. clinicians.

A joint task force of the American Academy of Allergy, Asthma, and Immunology (AAAAI) and the American College of Allergy, Asthma, and Immunology (ACAAI) is drafting the guidelines. While clinicians wait, here is a look at the evidence for efficacy and safety of SLIT – particularly when compared with subcutaneous immunotherapy – as well as at the progress of the guidelines, offered by Dr. Linda Cox, an allergist in private practice in Fort Lauderdale, Fla. Dr. Cox spoke at the annual meeting of the AAAAI.

The guidelines will closely follow package labeling for the three sublingual pollen-allergy medications approved last year by the Food and Drug Administration, Dr. Cox said. These are the multipollen allergen tablet Oralair (Stallergenes), the Timothy grass pollen tablet Grastek (Merck), and the ragweed tablet Ragwitek (Merck). The medicines’ indications differ in terms of minimum age for prescription, ranging from 5 to 18 years, and the timing of treatment, with Grastek indicated as a year-round treatment, and the others as seasonal treatments.

FDA labeling on all three medications recommends coprescription of epinephrine pens in case of systemic reactions, and Dr. Cox said that the AAAAI/ACAAI guidelines would reflect this. Nonetheless, coprescription of epi pens “has never been the standard in Europe or other parts of the globe. We don’t have guidance from the broader community in terms of when to take the epinephrine in terms of a SLIT reaction,” she noted. Physicians should “be aware and think about what sort of instructions you’re going to give your patients” on the use of epi pens.

The guidelines in progress advise physicians to counsel patients that site application symptoms such as itching and swelling are very common during the first week of SLIT treatment, and that the majority of SLIT reactions are local (oral, pharyngeal, or abdominal). These local reactions usually disappear within days to weeks without treatment or dose modification, though some can be severe or bothersome enough to discontinue treatment. Systemic allergic reactions are very uncommon.

The guidelines are also likely to caution physicians that there are insufficient studies comparing SLIT and subcutaneous immunotherapy, or SCIT, to make a definitive statement about efficacy, Dr. Cox said. They will note that available studies suggest SCIT is more effective in the first year of treatment than SLIT, and comparative long-term efficacy studies have not been conducted, she added.

Finally, the guidelines are likely to caution that SLIT is contraindicated in patients who are not likely to survive a systemic adverse reaction or the resultant treatment.

Dr. Cox did not say when the guidelines were likely to be published, just that “we are frantically trying to get this document together,” noting the short time that SLIT has been commercially available in the United States.

At the same session on SLIT, Dr. Desiree Larenas Linneman, an allergist in private practice in Mexico City, spoke at the meeting about practical concerns related to SLIT and how to choose whether a patient is better suited to shots or sublingual therapy.

“When you bring sublingual to the public there are several issues you are going to have to be very careful with,” Dr. Larenas Linneman said. Among these are prescriptions of highly concentrated medications by nonallergists, adherence, and patient preference. “And we still do not have data for SLIT on a vast array of comorbidities,” she said.

“When we only had SCIT, these patients came into our offices and the only decision was, would we go for shots or not?” Now the choices are more complicated. A multiallergic 8-year-old, ordinarily a good candidate for SCIT, might be better treated with tablets if the parent is adamant that the child not get shots, she said. An adult who travels constantly for work might find tablets more convenient.

But for multiallergic and highly allergic patients, SCIT is generally the more flexible and reliable option, Dr. Larenas Linneman said. Allergists have access to a great variety of different allergens they can combine to make SCIT, while the approved tablets cover only pollen. And a tablet is a fixed dose, she said, “so there’s no adjustment for highly allergic patients.”

Dr. Larenas Linneman noted that adherence and patient preference are closely related, something that physicians must keep in mind when choosing the form of immunotherapy to offer. “Adherence is a very important issue because we know adherence is quite poor both with SLIT and SCIT,” she said.

“Physicians think that what’s most important for the patient is efficacy, cost, and side effects,” but patients’ ability to comply is also key, she said, and clinicians should let patient preference guide their decisions when possible.

Dr. Cox disclosed ongoing consulting relationships with Greer and Circassia. Dr. Larenas Linnemann disclosed financial support from AstraZeneca, Pfizer, Novartis, MEDA, Sanofi, and Senosiain.

HOUSTON – Sublingual immunotherapy, or SLIT, long used by clinicians worldwide, is newly approved for use in the United States, and practice guidelines have yet to be published for U.S. clinicians.

A joint task force of the American Academy of Allergy, Asthma, and Immunology (AAAAI) and the American College of Allergy, Asthma, and Immunology (ACAAI) is drafting the guidelines. While clinicians wait, here is a look at the evidence for efficacy and safety of SLIT – particularly when compared with subcutaneous immunotherapy – as well as at the progress of the guidelines, offered by Dr. Linda Cox, an allergist in private practice in Fort Lauderdale, Fla. Dr. Cox spoke at the annual meeting of the AAAAI.

The guidelines will closely follow package labeling for the three sublingual pollen-allergy medications approved last year by the Food and Drug Administration, Dr. Cox said. These are the multipollen allergen tablet Oralair (Stallergenes), the Timothy grass pollen tablet Grastek (Merck), and the ragweed tablet Ragwitek (Merck). The medicines’ indications differ in terms of minimum age for prescription, ranging from 5 to 18 years, and the timing of treatment, with Grastek indicated as a year-round treatment, and the others as seasonal treatments.

FDA labeling on all three medications recommends coprescription of epinephrine pens in case of systemic reactions, and Dr. Cox said that the AAAAI/ACAAI guidelines would reflect this. Nonetheless, coprescription of epi pens “has never been the standard in Europe or other parts of the globe. We don’t have guidance from the broader community in terms of when to take the epinephrine in terms of a SLIT reaction,” she noted. Physicians should “be aware and think about what sort of instructions you’re going to give your patients” on the use of epi pens.

The guidelines in progress advise physicians to counsel patients that site application symptoms such as itching and swelling are very common during the first week of SLIT treatment, and that the majority of SLIT reactions are local (oral, pharyngeal, or abdominal). These local reactions usually disappear within days to weeks without treatment or dose modification, though some can be severe or bothersome enough to discontinue treatment. Systemic allergic reactions are very uncommon.

The guidelines are also likely to caution physicians that there are insufficient studies comparing SLIT and subcutaneous immunotherapy, or SCIT, to make a definitive statement about efficacy, Dr. Cox said. They will note that available studies suggest SCIT is more effective in the first year of treatment than SLIT, and comparative long-term efficacy studies have not been conducted, she added.

Finally, the guidelines are likely to caution that SLIT is contraindicated in patients who are not likely to survive a systemic adverse reaction or the resultant treatment.

Dr. Cox did not say when the guidelines were likely to be published, just that “we are frantically trying to get this document together,” noting the short time that SLIT has been commercially available in the United States.

At the same session on SLIT, Dr. Desiree Larenas Linneman, an allergist in private practice in Mexico City, spoke at the meeting about practical concerns related to SLIT and how to choose whether a patient is better suited to shots or sublingual therapy.

“When you bring sublingual to the public there are several issues you are going to have to be very careful with,” Dr. Larenas Linneman said. Among these are prescriptions of highly concentrated medications by nonallergists, adherence, and patient preference. “And we still do not have data for SLIT on a vast array of comorbidities,” she said.

“When we only had SCIT, these patients came into our offices and the only decision was, would we go for shots or not?” Now the choices are more complicated. A multiallergic 8-year-old, ordinarily a good candidate for SCIT, might be better treated with tablets if the parent is adamant that the child not get shots, she said. An adult who travels constantly for work might find tablets more convenient.

But for multiallergic and highly allergic patients, SCIT is generally the more flexible and reliable option, Dr. Larenas Linneman said. Allergists have access to a great variety of different allergens they can combine to make SCIT, while the approved tablets cover only pollen. And a tablet is a fixed dose, she said, “so there’s no adjustment for highly allergic patients.”

Dr. Larenas Linneman noted that adherence and patient preference are closely related, something that physicians must keep in mind when choosing the form of immunotherapy to offer. “Adherence is a very important issue because we know adherence is quite poor both with SLIT and SCIT,” she said.

“Physicians think that what’s most important for the patient is efficacy, cost, and side effects,” but patients’ ability to comply is also key, she said, and clinicians should let patient preference guide their decisions when possible.

Dr. Cox disclosed ongoing consulting relationships with Greer and Circassia. Dr. Larenas Linnemann disclosed financial support from AstraZeneca, Pfizer, Novartis, MEDA, Sanofi, and Senosiain.

HOUSTON – Dermatologists, allergists, and other physicians treating children with extremely refractory forms of atopic dermatitis (AD) must be aware of common treatment and management pitfalls before jumping to immunosuppressant or biologic therapies, says pediatric eczema researcher Dr. Donald Y. M. Leung, particularly as this is a patient group for whom no systemic therapies have been approved.

In a presentation at the annual meeting of the American Academy of Allergy, Asthma, and Immunology, Dr. Leung shared insights from his clinical experience at National Jewish Health in Denver, whose pediatric eczema program represents a national referral center for patients with severely refractory disease and their families.

“As managed care continues to march on, you will be faced with taking care of the more difficult patients,” Dr. Leung told clinicians.“You will see all forms of AD in clinical practice, therefore one size does not fit all, and a stepwise approach is needed to [treat] the different forms of eczema.”

Clinicians first need to determine what step, or grade, of eczema a patient has. For example, step 2 and 3 eczema is characterized by moderate disease not controlled by intermittent use of topical steroids or calcineurin inhibitors.

National Jewish Health’s day-based program aims to first clear up children presenting with severe eczema before clinicians attempt diagnostic testing. This is achieved through the use of wet wraps, until skin has healed enough for testing to begin.

With wet wraps and day hospitalization, “you can go from severe to mild within a few days,” Dr. Leung said. For children who do not improve after the wet wraps, ruling out immune deficiency or other diagnoses is key. Dr. Leung and colleagues look for Dock 8 (dedicator of cytokinesis 8) protein deficiency in children who fail to respond to wet-wrap treatment, especially if they have presented with recurrent herpes infections or persistent warts.

Another important function of the day program is to observe how parents manage children with eczema. Many, Dr. Leung said, turn out to be noncompliant with recommendations on bathing and medications, often because of the discomfort it causes the child. The monitoring is essential to reveal errors in care. “You can’t tell this in a 10-minute office visit,” he said.

A top reason children fail therapy, he said, is because parents misinterpret recommendations on applying medicine after bathing. Many think that after applying a topical medication, “you can get better absorption if you put the moisturizer on top of the topical steroid. That really just dilutes the medication and you get ineffective therapy.”

Another upshot of the monitoring is that clinicians can identify parents suffering from depression, stress, or financial problems that prevent them from complying. “As with asthma, psychosocial factors loom big,” he said. Parents are extensively counseled and referred as needed, he said. Children also can be trained not to scratch their skin, and children over 5 years in the eczema program are offered hypnosis and biofeedback training to learn how to control their response to itching.

When taking a history of suspected food reactions, Dr. Leung said, it’s important to note that only hives and anaphylaxis are clearly linked to food allergy. “Skin testing and blood work is what we all do, but that’s helpful only if negative. If it’s positive, it still doesn’t tell you that they have food-induced eczema, and like it or not, some form of the food challenge is necessary.”

Dr. Leung said it is appropriate to conduct some oral food challenges unblinded after a negative test. “If a test is positive, and the parent insists that this food may cause eczema, it’s often necessary to do a double-blind, placebo-controlled test,” he said, which is the gold standard.

In discussing systemic therapies, Dr. Leung noted that general immunosuppressants were an approach favored by dermatologists, but urged caution with regard to interferons, mycophenolate, methotrexate, azathioprine, and cyclosporin A. “These are expensive therapies not approved in children, and you really need very good documentation that they’ve failed other forms of therapy before you’d move to that,” Dr. Leung said.

Oral steroids should be avoided. “I have seen thousands of cases of severe eczema, and I’ve never put somebody on oral steroids unless they happened to have an asthma exacerbation concurrent with AD,” he said. “This is because they often have rebound within a week of stopping oral steroids, and that rebound can be worse than the disease you started with.”

If oral steroids must be used, “you should taper slowly and increase the intensity of skin care, so they don’t have a severe rebound.”

Dr. Leung said that while omalizumab should work in any disease with an elevated serum IgE level, “more often than not it doesn’t,” and it probably should be reserved for patients with a very clear history of allergen-induced eczema, underlying urticaria, or other forms of respiratory allergy that may be triggering asthma.

Two potential approaches in which allergists and dermatologists can work together, Dr. Leung said, are phototherapy and allergy immunotherapy. The latter is controversial in AD, he acknowledged, “but if somebody has mainly dust mite allergy or is monosensitized, it’s more likely you will get good benefit. If they’re polysensitized, it is unlikely because it’s mainly a barrier problem.”

Dr. Leung did not recommend antibiotics except in the case of overt Staphylococcus aureus infection, so as not to select for methicillin-resistant S. aureus (MRSA). “If you’re going to treat with some regimen, keep in mind that staph comes from the nose; that’s the body’s reservoir. You should always use an intranasal Bactroban [mupirocin] along with a systemic antibiotic.” Effective eradication of MRSA infection requires more drastic measures, including treatment of other family members and pets.

Dr. Leung disclosed doing consulting work for Celgene, Novartis, Regeneron, and Sanofi-Aventis, and a research grant from Horizon Pharma.

HOUSTON – Dermatologists, allergists, and other physicians treating children with extremely refractory forms of atopic dermatitis (AD) must be aware of common treatment and management pitfalls before jumping to immunosuppressant or biologic therapies, says pediatric eczema researcher Dr. Donald Y. M. Leung, particularly as this is a patient group for whom no systemic therapies have been approved.

In a presentation at the annual meeting of the American Academy of Allergy, Asthma, and Immunology, Dr. Leung shared insights from his clinical experience at National Jewish Health in Denver, whose pediatric eczema program represents a national referral center for patients with severely refractory disease and their families.

“As managed care continues to march on, you will be faced with taking care of the more difficult patients,” Dr. Leung told clinicians.“You will see all forms of AD in clinical practice, therefore one size does not fit all, and a stepwise approach is needed to [treat] the different forms of eczema.”

Clinicians first need to determine what step, or grade, of eczema a patient has. For example, step 2 and 3 eczema is characterized by moderate disease not controlled by intermittent use of topical steroids or calcineurin inhibitors.

National Jewish Health’s day-based program aims to first clear up children presenting with severe eczema before clinicians attempt diagnostic testing. This is achieved through the use of wet wraps, until skin has healed enough for testing to begin.

With wet wraps and day hospitalization, “you can go from severe to mild within a few days,” Dr. Leung said. For children who do not improve after the wet wraps, ruling out immune deficiency or other diagnoses is key. Dr. Leung and colleagues look for Dock 8 (dedicator of cytokinesis 8) protein deficiency in children who fail to respond to wet-wrap treatment, especially if they have presented with recurrent herpes infections or persistent warts.

Another important function of the day program is to observe how parents manage children with eczema. Many, Dr. Leung said, turn out to be noncompliant with recommendations on bathing and medications, often because of the discomfort it causes the child. The monitoring is essential to reveal errors in care. “You can’t tell this in a 10-minute office visit,” he said.

A top reason children fail therapy, he said, is because parents misinterpret recommendations on applying medicine after bathing. Many think that after applying a topical medication, “you can get better absorption if you put the moisturizer on top of the topical steroid. That really just dilutes the medication and you get ineffective therapy.”

Another upshot of the monitoring is that clinicians can identify parents suffering from depression, stress, or financial problems that prevent them from complying. “As with asthma, psychosocial factors loom big,” he said. Parents are extensively counseled and referred as needed, he said. Children also can be trained not to scratch their skin, and children over 5 years in the eczema program are offered hypnosis and biofeedback training to learn how to control their response to itching.

When taking a history of suspected food reactions, Dr. Leung said, it’s important to note that only hives and anaphylaxis are clearly linked to food allergy. “Skin testing and blood work is what we all do, but that’s helpful only if negative. If it’s positive, it still doesn’t tell you that they have food-induced eczema, and like it or not, some form of the food challenge is necessary.”

Dr. Leung said it is appropriate to conduct some oral food challenges unblinded after a negative test. “If a test is positive, and the parent insists that this food may cause eczema, it’s often necessary to do a double-blind, placebo-controlled test,” he said, which is the gold standard.

In discussing systemic therapies, Dr. Leung noted that general immunosuppressants were an approach favored by dermatologists, but urged caution with regard to interferons, mycophenolate, methotrexate, azathioprine, and cyclosporin A. “These are expensive therapies not approved in children, and you really need very good documentation that they’ve failed other forms of therapy before you’d move to that,” Dr. Leung said.

Oral steroids should be avoided. “I have seen thousands of cases of severe eczema, and I’ve never put somebody on oral steroids unless they happened to have an asthma exacerbation concurrent with AD,” he said. “This is because they often have rebound within a week of stopping oral steroids, and that rebound can be worse than the disease you started with.”

If oral steroids must be used, “you should taper slowly and increase the intensity of skin care, so they don’t have a severe rebound.”

Dr. Leung said that while omalizumab should work in any disease with an elevated serum IgE level, “more often than not it doesn’t,” and it probably should be reserved for patients with a very clear history of allergen-induced eczema, underlying urticaria, or other forms of respiratory allergy that may be triggering asthma.

Two potential approaches in which allergists and dermatologists can work together, Dr. Leung said, are phototherapy and allergy immunotherapy. The latter is controversial in AD, he acknowledged, “but if somebody has mainly dust mite allergy or is monosensitized, it’s more likely you will get good benefit. If they’re polysensitized, it is unlikely because it’s mainly a barrier problem.”

Dr. Leung did not recommend antibiotics except in the case of overt Staphylococcus aureus infection, so as not to select for methicillin-resistant S. aureus (MRSA). “If you’re going to treat with some regimen, keep in mind that staph comes from the nose; that’s the body’s reservoir. You should always use an intranasal Bactroban [mupirocin] along with a systemic antibiotic.” Effective eradication of MRSA infection requires more drastic measures, including treatment of other family members and pets.

Dr. Leung disclosed doing consulting work for Celgene, Novartis, Regeneron, and Sanofi-Aventis, and a research grant from Horizon Pharma.

HOUSTON – Dermatologists, allergists, and other physicians treating children with extremely refractory forms of atopic dermatitis (AD) must be aware of common treatment and management pitfalls before jumping to immunosuppressant or biologic therapies, says pediatric eczema researcher Dr. Donald Y. M. Leung, particularly as this is a patient group for whom no systemic therapies have been approved.

In a presentation at the annual meeting of the American Academy of Allergy, Asthma, and Immunology, Dr. Leung shared insights from his clinical experience at National Jewish Health in Denver, whose pediatric eczema program represents a national referral center for patients with severely refractory disease and their families.

“As managed care continues to march on, you will be faced with taking care of the more difficult patients,” Dr. Leung told clinicians.“You will see all forms of AD in clinical practice, therefore one size does not fit all, and a stepwise approach is needed to [treat] the different forms of eczema.”

Clinicians first need to determine what step, or grade, of eczema a patient has. For example, step 2 and 3 eczema is characterized by moderate disease not controlled by intermittent use of topical steroids or calcineurin inhibitors.

National Jewish Health’s day-based program aims to first clear up children presenting with severe eczema before clinicians attempt diagnostic testing. This is achieved through the use of wet wraps, until skin has healed enough for testing to begin.

With wet wraps and day hospitalization, “you can go from severe to mild within a few days,” Dr. Leung said. For children who do not improve after the wet wraps, ruling out immune deficiency or other diagnoses is key. Dr. Leung and colleagues look for Dock 8 (dedicator of cytokinesis 8) protein deficiency in children who fail to respond to wet-wrap treatment, especially if they have presented with recurrent herpes infections or persistent warts.

Another important function of the day program is to observe how parents manage children with eczema. Many, Dr. Leung said, turn out to be noncompliant with recommendations on bathing and medications, often because of the discomfort it causes the child. The monitoring is essential to reveal errors in care. “You can’t tell this in a 10-minute office visit,” he said.

A top reason children fail therapy, he said, is because parents misinterpret recommendations on applying medicine after bathing. Many think that after applying a topical medication, “you can get better absorption if you put the moisturizer on top of the topical steroid. That really just dilutes the medication and you get ineffective therapy.”

Another upshot of the monitoring is that clinicians can identify parents suffering from depression, stress, or financial problems that prevent them from complying. “As with asthma, psychosocial factors loom big,” he said. Parents are extensively counseled and referred as needed, he said. Children also can be trained not to scratch their skin, and children over 5 years in the eczema program are offered hypnosis and biofeedback training to learn how to control their response to itching.

When taking a history of suspected food reactions, Dr. Leung said, it’s important to note that only hives and anaphylaxis are clearly linked to food allergy. “Skin testing and blood work is what we all do, but that’s helpful only if negative. If it’s positive, it still doesn’t tell you that they have food-induced eczema, and like it or not, some form of the food challenge is necessary.”

Dr. Leung said it is appropriate to conduct some oral food challenges unblinded after a negative test. “If a test is positive, and the parent insists that this food may cause eczema, it’s often necessary to do a double-blind, placebo-controlled test,” he said, which is the gold standard.

In discussing systemic therapies, Dr. Leung noted that general immunosuppressants were an approach favored by dermatologists, but urged caution with regard to interferons, mycophenolate, methotrexate, azathioprine, and cyclosporin A. “These are expensive therapies not approved in children, and you really need very good documentation that they’ve failed other forms of therapy before you’d move to that,” Dr. Leung said.

Oral steroids should be avoided. “I have seen thousands of cases of severe eczema, and I’ve never put somebody on oral steroids unless they happened to have an asthma exacerbation concurrent with AD,” he said. “This is because they often have rebound within a week of stopping oral steroids, and that rebound can be worse than the disease you started with.”

If oral steroids must be used, “you should taper slowly and increase the intensity of skin care, so they don’t have a severe rebound.”

Dr. Leung said that while omalizumab should work in any disease with an elevated serum IgE level, “more often than not it doesn’t,” and it probably should be reserved for patients with a very clear history of allergen-induced eczema, underlying urticaria, or other forms of respiratory allergy that may be triggering asthma.

Two potential approaches in which allergists and dermatologists can work together, Dr. Leung said, are phototherapy and allergy immunotherapy. The latter is controversial in AD, he acknowledged, “but if somebody has mainly dust mite allergy or is monosensitized, it’s more likely you will get good benefit. If they’re polysensitized, it is unlikely because it’s mainly a barrier problem.”

Dr. Leung did not recommend antibiotics except in the case of overt Staphylococcus aureus infection, so as not to select for methicillin-resistant S. aureus (MRSA). “If you’re going to treat with some regimen, keep in mind that staph comes from the nose; that’s the body’s reservoir. You should always use an intranasal Bactroban [mupirocin] along with a systemic antibiotic.” Effective eradication of MRSA infection requires more drastic measures, including treatment of other family members and pets.

Dr. Leung disclosed doing consulting work for Celgene, Novartis, Regeneron, and Sanofi-Aventis, and a research grant from Horizon Pharma.

U.S. adults with eczema reported significantly more out-of-pocket health care costs, lost workdays, and comorbid conditions than did their peers without eczema, according to a population-based study reported online March 4 in JAMA Dermatology.

Adult eczema patients also used significantly more health care resources than did adults without eczema, despite reporting more problems accessing care, said Dr. Jonathan I. Silverberg at Northwestern University in Chicago.

About 10.2% of U.S. adults have eczema (atopic dermatitis), but not much is known about its recent direct and indirect health care costs. To explore these questions, Dr. Silverberg analyzed data from the 2010 and 2012 National Health Interview Surveys, which included 27,157 and 34,613 adults, respectively (JAMA Dermatol. 2015 [doi:10.1001/jamadermatol.2014.5432]).

Eczema was linked to 53% higher odds of losing six or more workdays for any reason (odds ratio, 1.53; 95% confidence interval, 1.26-1.84), and with significantly higher odds of visits to physicians’ offices, emergency departments, urgent care centers, and hospitals for all causes, Dr. Silverberg reported. Adults with eczema also paid an estimated $371 to $489 more in out-of-pocket health care costs per year, compared with other adults, he added. “This study demonstrates that adults with eczema have a major health burden with significantly increased health care utilization and costs,” he emphasized.But greater utilization of care “was only partially due to eczema per se,” Dr. Silverberg noted. “There is likely a multitude of comorbid disorders associated with eczema that contributes toward the increased utilization, aside from EAH [eczema with allergy and/or hay fever], or food allergy,” he said. “Indeed, there were significant statistical interactions, such that adults with EAH had even greater burden of disease, out-of-pocket costs, and health care utilization.”

Past studies have shown that children with eczema have more extracutaneous infections, dental disease, and mental health problems, compared with peers who do not have eczema, Dr. Silverberg pointed out, adding that future studies should explore the clinical and financial implications of comorbidities in eczema patients.Eczema also was associated with impaired access to care, Dr. Silverberg said. Affected adults were significantly more likely to describe problems paying for prescriptions (OR, 2.36; 95% CI, 1.92-2.81), getting timely appointments (OR, 2.04; 95% CI, 1.73-2.41), and obtaining care because of worry about costs (OR, 1.66; 95% CI, 1.40-1.97), compared with adults without eczema, Dr. Silverberg said. “Future studies are needed to identify the determinants of health care utilization and access in adults with eczema,” he concluded.

The Agency for Healthcare Research and Quality funded the study. Dr. Silverberg reported having no relevant conflicts of interest.

U.S. adults with eczema reported significantly more out-of-pocket health care costs, lost workdays, and comorbid conditions than did their peers without eczema, according to a population-based study reported online March 4 in JAMA Dermatology.

Adult eczema patients also used significantly more health care resources than did adults without eczema, despite reporting more problems accessing care, said Dr. Jonathan I. Silverberg at Northwestern University in Chicago.

About 10.2% of U.S. adults have eczema (atopic dermatitis), but not much is known about its recent direct and indirect health care costs. To explore these questions, Dr. Silverberg analyzed data from the 2010 and 2012 National Health Interview Surveys, which included 27,157 and 34,613 adults, respectively (JAMA Dermatol. 2015 [doi:10.1001/jamadermatol.2014.5432]).

Eczema was linked to 53% higher odds of losing six or more workdays for any reason (odds ratio, 1.53; 95% confidence interval, 1.26-1.84), and with significantly higher odds of visits to physicians’ offices, emergency departments, urgent care centers, and hospitals for all causes, Dr. Silverberg reported. Adults with eczema also paid an estimated $371 to $489 more in out-of-pocket health care costs per year, compared with other adults, he added. “This study demonstrates that adults with eczema have a major health burden with significantly increased health care utilization and costs,” he emphasized.But greater utilization of care “was only partially due to eczema per se,” Dr. Silverberg noted. “There is likely a multitude of comorbid disorders associated with eczema that contributes toward the increased utilization, aside from EAH [eczema with allergy and/or hay fever], or food allergy,” he said. “Indeed, there were significant statistical interactions, such that adults with EAH had even greater burden of disease, out-of-pocket costs, and health care utilization.”

Past studies have shown that children with eczema have more extracutaneous infections, dental disease, and mental health problems, compared with peers who do not have eczema, Dr. Silverberg pointed out, adding that future studies should explore the clinical and financial implications of comorbidities in eczema patients.Eczema also was associated with impaired access to care, Dr. Silverberg said. Affected adults were significantly more likely to describe problems paying for prescriptions (OR, 2.36; 95% CI, 1.92-2.81), getting timely appointments (OR, 2.04; 95% CI, 1.73-2.41), and obtaining care because of worry about costs (OR, 1.66; 95% CI, 1.40-1.97), compared with adults without eczema, Dr. Silverberg said. “Future studies are needed to identify the determinants of health care utilization and access in adults with eczema,” he concluded.

The Agency for Healthcare Research and Quality funded the study. Dr. Silverberg reported having no relevant conflicts of interest.

U.S. adults with eczema reported significantly more out-of-pocket health care costs, lost workdays, and comorbid conditions than did their peers without eczema, according to a population-based study reported online March 4 in JAMA Dermatology.

Adult eczema patients also used significantly more health care resources than did adults without eczema, despite reporting more problems accessing care, said Dr. Jonathan I. Silverberg at Northwestern University in Chicago.

About 10.2% of U.S. adults have eczema (atopic dermatitis), but not much is known about its recent direct and indirect health care costs. To explore these questions, Dr. Silverberg analyzed data from the 2010 and 2012 National Health Interview Surveys, which included 27,157 and 34,613 adults, respectively (JAMA Dermatol. 2015 [doi:10.1001/jamadermatol.2014.5432]).

Eczema was linked to 53% higher odds of losing six or more workdays for any reason (odds ratio, 1.53; 95% confidence interval, 1.26-1.84), and with significantly higher odds of visits to physicians’ offices, emergency departments, urgent care centers, and hospitals for all causes, Dr. Silverberg reported. Adults with eczema also paid an estimated $371 to $489 more in out-of-pocket health care costs per year, compared with other adults, he added. “This study demonstrates that adults with eczema have a major health burden with significantly increased health care utilization and costs,” he emphasized.But greater utilization of care “was only partially due to eczema per se,” Dr. Silverberg noted. “There is likely a multitude of comorbid disorders associated with eczema that contributes toward the increased utilization, aside from EAH [eczema with allergy and/or hay fever], or food allergy,” he said. “Indeed, there were significant statistical interactions, such that adults with EAH had even greater burden of disease, out-of-pocket costs, and health care utilization.”

Past studies have shown that children with eczema have more extracutaneous infections, dental disease, and mental health problems, compared with peers who do not have eczema, Dr. Silverberg pointed out, adding that future studies should explore the clinical and financial implications of comorbidities in eczema patients.Eczema also was associated with impaired access to care, Dr. Silverberg said. Affected adults were significantly more likely to describe problems paying for prescriptions (OR, 2.36; 95% CI, 1.92-2.81), getting timely appointments (OR, 2.04; 95% CI, 1.73-2.41), and obtaining care because of worry about costs (OR, 1.66; 95% CI, 1.40-1.97), compared with adults without eczema, Dr. Silverberg said. “Future studies are needed to identify the determinants of health care utilization and access in adults with eczema,” he concluded.

The Agency for Healthcare Research and Quality funded the study. Dr. Silverberg reported having no relevant conflicts of interest.

KAUAI, HAWAII – Don’t waste your time on “yet another antihistamine” when first- and second-line therapies fail for refractory urticaria.

That’s what Dr. Joseph Eastern advised physicians at the annual Hawaii Dermatology Seminar sponsored by Global Academy for Medical Education/Skin Disease Education Foundation.

“There is just not enough evidence to support using antihistamines and playing roulette with your patient’s health,” Dr. Eastern said, noting that the degree of disability, both socially and occupationally, that accompanies chronic urticaria is on par with that of a patient awaiting triple coronary bypass.

Also not on Dr. Eastern’s list of go-to treatments for the condition are thyroxine replacement, special diets, or anti-Helicobacter pylori treatment, despite some in the field who believe there is an overlap in the pathogenesis of urticaria and this gastrointestinal infection. “None of these are supported by credible evidence,” Dr. Eastern, a dermatologist in private practice in Belleville, N.J., said in an interview.

Once second-line therapies such as doxepin, leukotriene antagonists, corticosteroids, dapsone, sulfasalzine, and even narrow-band UVB are exhausted, Dr. Eastern suggested using off-label immunosuppressants for chronic urticaria as third-line treatment. He discussed three in particular:

• Cyclosporine. At least three randomized controlled trials support the safety and efficacy of cyclosporine in chronic urticaria. Dr. Eastern noted that, in a 2011 study, the drug was particularly effective in chronic urticaria that had shorter duration of disease and a CU (chronic urticaria) index of 10 or less (Ann. Allergy Asthma Immunol. 2011;107:523-8).

The most effective dosing seems to be between 3 mg/kg per day and 6 mg/kg per day, given over the course of 2-3 months (Br. J. Dermatol. 2000;143:365-72). Approximately 80% of patients responded well to treatment (J. Dermatol. 2008;35:276-82). Of those, one-third experienced complete remission of symptoms, another third experienced mild relapse, and one-third relapsed more severely. Dr. Eastern noted that long-term use of cyclosporine is associated with risks of hypertension and renal impairment.

• Methotrexate. Although there are no randomized controlled studies to support the use of methotrexate for chronic urticaria, there have been reported anecdotal successes, Dr. Eastern said. The benefits seem to be in the drug’s anti-inflammatory and immunosuppressive effects (Br. J. Dermatol. 2010;162:191-4).

“Methotrexate may be of benefit independently of the pathogenic mechanism of urticaria and is a viable option in situations where the cost of therapy is a significant concern,” he said in the interview.

• Omalizumab. This recombinant humanized monoclonal antibody, which selectively binds to, and lowers, serum IgE, is “the new kid on the block,” Dr. Eastern said. “The results are impressive, particularly in patients with demonstrable autoantibodies to IgE, but insurance approval is often difficult to obtain, due to the drug’s expense.”

Two other treatments clinicians could consider are high-dose intravenous immunoglobulin (0.4 g/kg for 5 days) and plasmapheresis, according to Dr. Eastern. The former’s mechanism of action is unclear at this point, but in patients with severe, unremitting chronic urticaria, plasmapheresis was shown to eliminate the functional autoantibodies, favoring a pathogenic role.

When all else fails, Dr. Eastern urged physicians to reconsider the diagnosis.

“The presence of systemic symptoms could mean the urticarial rash is not ordinary urticaria,” he said, suggesting that vasculitis, Schitzler’s syndrome, adult-onset Still’s disease, an autoinflammatory syndrome, or urticarial dermatitis could be at play.

Dr. Eastern disclosed that he serves as a consultant to Genentech, which markets omalizumab as Xolair.

SDEF and this news organization are owned by the same parent company.

[email protected]

On Twitter @whitneymcknight

KAUAI, HAWAII – Don’t waste your time on “yet another antihistamine” when first- and second-line therapies fail for refractory urticaria.

That’s what Dr. Joseph Eastern advised physicians at the annual Hawaii Dermatology Seminar sponsored by Global Academy for Medical Education/Skin Disease Education Foundation.

“There is just not enough evidence to support using antihistamines and playing roulette with your patient’s health,” Dr. Eastern said, noting that the degree of disability, both socially and occupationally, that accompanies chronic urticaria is on par with that of a patient awaiting triple coronary bypass.

Also not on Dr. Eastern’s list of go-to treatments for the condition are thyroxine replacement, special diets, or anti-Helicobacter pylori treatment, despite some in the field who believe there is an overlap in the pathogenesis of urticaria and this gastrointestinal infection. “None of these are supported by credible evidence,” Dr. Eastern, a dermatologist in private practice in Belleville, N.J., said in an interview.

Once second-line therapies such as doxepin, leukotriene antagonists, corticosteroids, dapsone, sulfasalzine, and even narrow-band UVB are exhausted, Dr. Eastern suggested using off-label immunosuppressants for chronic urticaria as third-line treatment. He discussed three in particular:

• Cyclosporine. At least three randomized controlled trials support the safety and efficacy of cyclosporine in chronic urticaria. Dr. Eastern noted that, in a 2011 study, the drug was particularly effective in chronic urticaria that had shorter duration of disease and a CU (chronic urticaria) index of 10 or less (Ann. Allergy Asthma Immunol. 2011;107:523-8).

The most effective dosing seems to be between 3 mg/kg per day and 6 mg/kg per day, given over the course of 2-3 months (Br. J. Dermatol. 2000;143:365-72). Approximately 80% of patients responded well to treatment (J. Dermatol. 2008;35:276-82). Of those, one-third experienced complete remission of symptoms, another third experienced mild relapse, and one-third relapsed more severely. Dr. Eastern noted that long-term use of cyclosporine is associated with risks of hypertension and renal impairment.

• Methotrexate. Although there are no randomized controlled studies to support the use of methotrexate for chronic urticaria, there have been reported anecdotal successes, Dr. Eastern said. The benefits seem to be in the drug’s anti-inflammatory and immunosuppressive effects (Br. J. Dermatol. 2010;162:191-4).

“Methotrexate may be of benefit independently of the pathogenic mechanism of urticaria and is a viable option in situations where the cost of therapy is a significant concern,” he said in the interview.

• Omalizumab. This recombinant humanized monoclonal antibody, which selectively binds to, and lowers, serum IgE, is “the new kid on the block,” Dr. Eastern said. “The results are impressive, particularly in patients with demonstrable autoantibodies to IgE, but insurance approval is often difficult to obtain, due to the drug’s expense.”

Two other treatments clinicians could consider are high-dose intravenous immunoglobulin (0.4 g/kg for 5 days) and plasmapheresis, according to Dr. Eastern. The former’s mechanism of action is unclear at this point, but in patients with severe, unremitting chronic urticaria, plasmapheresis was shown to eliminate the functional autoantibodies, favoring a pathogenic role.

When all else fails, Dr. Eastern urged physicians to reconsider the diagnosis.

“The presence of systemic symptoms could mean the urticarial rash is not ordinary urticaria,” he said, suggesting that vasculitis, Schitzler’s syndrome, adult-onset Still’s disease, an autoinflammatory syndrome, or urticarial dermatitis could be at play.

Dr. Eastern disclosed that he serves as a consultant to Genentech, which markets omalizumab as Xolair.

SDEF and this news organization are owned by the same parent company.

[email protected]

On Twitter @whitneymcknight

KAUAI, HAWAII – Don’t waste your time on “yet another antihistamine” when first- and second-line therapies fail for refractory urticaria.

That’s what Dr. Joseph Eastern advised physicians at the annual Hawaii Dermatology Seminar sponsored by Global Academy for Medical Education/Skin Disease Education Foundation.

“There is just not enough evidence to support using antihistamines and playing roulette with your patient’s health,” Dr. Eastern said, noting that the degree of disability, both socially and occupationally, that accompanies chronic urticaria is on par with that of a patient awaiting triple coronary bypass.

Also not on Dr. Eastern’s list of go-to treatments for the condition are thyroxine replacement, special diets, or anti-Helicobacter pylori treatment, despite some in the field who believe there is an overlap in the pathogenesis of urticaria and this gastrointestinal infection. “None of these are supported by credible evidence,” Dr. Eastern, a dermatologist in private practice in Belleville, N.J., said in an interview.

Once second-line therapies such as doxepin, leukotriene antagonists, corticosteroids, dapsone, sulfasalzine, and even narrow-band UVB are exhausted, Dr. Eastern suggested using off-label immunosuppressants for chronic urticaria as third-line treatment. He discussed three in particular:

• Cyclosporine. At least three randomized controlled trials support the safety and efficacy of cyclosporine in chronic urticaria. Dr. Eastern noted that, in a 2011 study, the drug was particularly effective in chronic urticaria that had shorter duration of disease and a CU (chronic urticaria) index of 10 or less (Ann. Allergy Asthma Immunol. 2011;107:523-8).

The most effective dosing seems to be between 3 mg/kg per day and 6 mg/kg per day, given over the course of 2-3 months (Br. J. Dermatol. 2000;143:365-72). Approximately 80% of patients responded well to treatment (J. Dermatol. 2008;35:276-82). Of those, one-third experienced complete remission of symptoms, another third experienced mild relapse, and one-third relapsed more severely. Dr. Eastern noted that long-term use of cyclosporine is associated with risks of hypertension and renal impairment.

• Methotrexate. Although there are no randomized controlled studies to support the use of methotrexate for chronic urticaria, there have been reported anecdotal successes, Dr. Eastern said. The benefits seem to be in the drug’s anti-inflammatory and immunosuppressive effects (Br. J. Dermatol. 2010;162:191-4).

“Methotrexate may be of benefit independently of the pathogenic mechanism of urticaria and is a viable option in situations where the cost of therapy is a significant concern,” he said in the interview.

• Omalizumab. This recombinant humanized monoclonal antibody, which selectively binds to, and lowers, serum IgE, is “the new kid on the block,” Dr. Eastern said. “The results are impressive, particularly in patients with demonstrable autoantibodies to IgE, but insurance approval is often difficult to obtain, due to the drug’s expense.”

Two other treatments clinicians could consider are high-dose intravenous immunoglobulin (0.4 g/kg for 5 days) and plasmapheresis, according to Dr. Eastern. The former’s mechanism of action is unclear at this point, but in patients with severe, unremitting chronic urticaria, plasmapheresis was shown to eliminate the functional autoantibodies, favoring a pathogenic role.

When all else fails, Dr. Eastern urged physicians to reconsider the diagnosis.

“The presence of systemic symptoms could mean the urticarial rash is not ordinary urticaria,” he said, suggesting that vasculitis, Schitzler’s syndrome, adult-onset Still’s disease, an autoinflammatory syndrome, or urticarial dermatitis could be at play.

Dr. Eastern disclosed that he serves as a consultant to Genentech, which markets omalizumab as Xolair.

SDEF and this news organization are owned by the same parent company.

[email protected]

On Twitter @whitneymcknight

HOUSTON – The introduction of peanuts at an early age to children who are more highly predisposed to having a peanut allergy can induce tolerance of peanuts and thereby significantly decrease the likelihood of developing a sustained allergy.

This finding from the Learning Early about Peanut Allergy (LEAP) study was presented at the annual meeting of the American Academy of Allergy, Asthma, and Immunology and simultaneously published by the New England Journal of Medicine. Investigators enrolled 640 infants aged 4-11 months between December 2006 and May 6, 2009, all of whom were given skin-prick tests at baseline to determine existing peanut allergies, and randomized them into cohorts that would either consume or avoid peanuts until they reached 60 months of age (N. Engl. J. Med. 2015 Feb. 23 [doi:10.1056/NEJMoa1414850]).

© mates/Fotolia.com

Of the 530 children who had negative skin-prick test results, the prevalence of peanut allergy after 60 months was 13.7% in the avoidance cohort and 1.9% in the consumption cohort (P < .001). Of 98 children who had positive skin-prick test results, 35% of the avoidance cohort had peanut allergy after 60 months, while only 11% of the consumption cohort had the allergy (P = .004). Several children who were initially enrolled and randomized either dropped out or were excluded because of inadequate adherence to treatment or missing data.

Outcomes were measured by placing children in a double-blind, placebo-controlled study that had them consume a cumulative total of 9.4 g of peanut protein to determine whether or not tolerance to peanuts had been effectively induced. All children consumed peanuts by eating peanut butter or a peanut-based snack called Bamba, which was provided for the study at a discounted rate. Children whose skin-prick tests showed wheals of larger than 4 mm in diameter were excluded for presumed existing peanut allergy.

“If you enroll children after 11 months of age, you get about twice the rate of [already allergic] children, with a steady decline as [age] goes down,” corresponding author Dr. Gideon Lack, head of the department of pediatric allergy at King’s College, London, said in a press conference following presentation of the study. “But of children younger than 5 months of age, none of them were peanut allergic, so that would suggest that timing here is key: There is a narrow window of opportunity to intervene if you want to be effective.”

Investigators also noted that children who consumed peanuts had increased levels of IgG4 antibody, while those told to avoid peanuts had higher levels of IgE antibody. They also found that development of peanut allergy was generally associated with subjects who both displayed larger wheals on the skin-prick test and had a lower ratio of IgG4:IgE antibodies. Skin-prick tests that yielded wheals of 1-2 mm in diameter were considered indicative of early risk for peanut allergy.

There was no significant difference in the rates of adverse events or hospitalizations between the consumption and avoidance cohort, but 99% of subjects in each group did experience at least one adverse event: 4,527 in the consumption cohort and 4,287 in the avoidance cohort (P = .02). Infants who consumed peanuts had higher instances of upper respiratory tract infection, viral skin infection, gastroenteritis, urticaria, and conjunctivitis, but events mostly ranged from mild to moderate and their severity was not significantly different from similar incidents reported in the avoidance cohort.

Hospitalization rates also were low, with 52 children in the avoidance cohort and 50 children who consumed peanuts being admitted over the study interval, or 16.2% and 15.7%, respectively (P = .86). Rates of serious adverse effects also were not significantly different between the two cohorts, with 101 children who avoided peanuts and 89 who consumed peanuts experiencing such events (P = .41).

Adequate adherence to treatment for the children randomized into the peanut-avoidance group was defined as eating less than 0.2 g of peanut protein on any single occasion and no more than 0.5 g over the course of a single week in the first 24 months of life. For children in the consumption cohort, adequate adherence meant consuming at least 2 g of peanut protein on at least one occasion in both the first and second years of life, and at least 3 g of peanut protein weekly for at least half the number of weeks for which data was collected.

“Whether or not these benefits can be sustained, we will find out in 1 year,” Dr. Lack said, adding that “all the children who had been consuming peanut have stopped [for] 1 year, and we will see if peanut allergy persists after 1 year of cessation of consumption.” He predicted that the findings would most likely produce a mixed response, with some children relapsing while others maintain sustained tolerance.

The LEAP study was supported by grants from the National Institute of Allergy and Infectious Diseases, Food Allergy and Research Education, the Medical Research Council and Asthma UK, the UK Department of Health’s National Institute for Health Research, the National Peanut Board, and the UK Food Standards Agency. Dr. Lack disclosed financial affiliations with DBV Technologies, and coauthor Dr. Helen Brough disclosed receiving financial support from Fare and Action Medical Research, along with study materials from Stallergenes, Thermo Scientific, and Meridian Foods.

[email protected]

HOUSTON – The introduction of peanuts at an early age to children who are more highly predisposed to having a peanut allergy can induce tolerance of peanuts and thereby significantly decrease the likelihood of developing a sustained allergy.

This finding from the Learning Early about Peanut Allergy (LEAP) study was presented at the annual meeting of the American Academy of Allergy, Asthma, and Immunology and simultaneously published by the New England Journal of Medicine. Investigators enrolled 640 infants aged 4-11 months between December 2006 and May 6, 2009, all of whom were given skin-prick tests at baseline to determine existing peanut allergies, and randomized them into cohorts that would either consume or avoid peanuts until they reached 60 months of age (N. Engl. J. Med. 2015 Feb. 23 [doi:10.1056/NEJMoa1414850]).

© mates/Fotolia.com

Of the 530 children who had negative skin-prick test results, the prevalence of peanut allergy after 60 months was 13.7% in the avoidance cohort and 1.9% in the consumption cohort (P < .001). Of 98 children who had positive skin-prick test results, 35% of the avoidance cohort had peanut allergy after 60 months, while only 11% of the consumption cohort had the allergy (P = .004). Several children who were initially enrolled and randomized either dropped out or were excluded because of inadequate adherence to treatment or missing data.

Outcomes were measured by placing children in a double-blind, placebo-controlled study that had them consume a cumulative total of 9.4 g of peanut protein to determine whether or not tolerance to peanuts had been effectively induced. All children consumed peanuts by eating peanut butter or a peanut-based snack called Bamba, which was provided for the study at a discounted rate. Children whose skin-prick tests showed wheals of larger than 4 mm in diameter were excluded for presumed existing peanut allergy.

“If you enroll children after 11 months of age, you get about twice the rate of [already allergic] children, with a steady decline as [age] goes down,” corresponding author Dr. Gideon Lack, head of the department of pediatric allergy at King’s College, London, said in a press conference following presentation of the study. “But of children younger than 5 months of age, none of them were peanut allergic, so that would suggest that timing here is key: There is a narrow window of opportunity to intervene if you want to be effective.”

Investigators also noted that children who consumed peanuts had increased levels of IgG4 antibody, while those told to avoid peanuts had higher levels of IgE antibody. They also found that development of peanut allergy was generally associated with subjects who both displayed larger wheals on the skin-prick test and had a lower ratio of IgG4:IgE antibodies. Skin-prick tests that yielded wheals of 1-2 mm in diameter were considered indicative of early risk for peanut allergy.

There was no significant difference in the rates of adverse events or hospitalizations between the consumption and avoidance cohort, but 99% of subjects in each group did experience at least one adverse event: 4,527 in the consumption cohort and 4,287 in the avoidance cohort (P = .02). Infants who consumed peanuts had higher instances of upper respiratory tract infection, viral skin infection, gastroenteritis, urticaria, and conjunctivitis, but events mostly ranged from mild to moderate and their severity was not significantly different from similar incidents reported in the avoidance cohort.

Hospitalization rates also were low, with 52 children in the avoidance cohort and 50 children who consumed peanuts being admitted over the study interval, or 16.2% and 15.7%, respectively (P = .86). Rates of serious adverse effects also were not significantly different between the two cohorts, with 101 children who avoided peanuts and 89 who consumed peanuts experiencing such events (P = .41).

Adequate adherence to treatment for the children randomized into the peanut-avoidance group was defined as eating less than 0.2 g of peanut protein on any single occasion and no more than 0.5 g over the course of a single week in the first 24 months of life. For children in the consumption cohort, adequate adherence meant consuming at least 2 g of peanut protein on at least one occasion in both the first and second years of life, and at least 3 g of peanut protein weekly for at least half the number of weeks for which data was collected.

“Whether or not these benefits can be sustained, we will find out in 1 year,” Dr. Lack said, adding that “all the children who had been consuming peanut have stopped [for] 1 year, and we will see if peanut allergy persists after 1 year of cessation of consumption.” He predicted that the findings would most likely produce a mixed response, with some children relapsing while others maintain sustained tolerance.

The LEAP study was supported by grants from the National Institute of Allergy and Infectious Diseases, Food Allergy and Research Education, the Medical Research Council and Asthma UK, the UK Department of Health’s National Institute for Health Research, the National Peanut Board, and the UK Food Standards Agency. Dr. Lack disclosed financial affiliations with DBV Technologies, and coauthor Dr. Helen Brough disclosed receiving financial support from Fare and Action Medical Research, along with study materials from Stallergenes, Thermo Scientific, and Meridian Foods.

[email protected]

HOUSTON – The introduction of peanuts at an early age to children who are more highly predisposed to having a peanut allergy can induce tolerance of peanuts and thereby significantly decrease the likelihood of developing a sustained allergy.

This finding from the Learning Early about Peanut Allergy (LEAP) study was presented at the annual meeting of the American Academy of Allergy, Asthma, and Immunology and simultaneously published by the New England Journal of Medicine. Investigators enrolled 640 infants aged 4-11 months between December 2006 and May 6, 2009, all of whom were given skin-prick tests at baseline to determine existing peanut allergies, and randomized them into cohorts that would either consume or avoid peanuts until they reached 60 months of age (N. Engl. J. Med. 2015 Feb. 23 [doi:10.1056/NEJMoa1414850]).

© mates/Fotolia.com

Of the 530 children who had negative skin-prick test results, the prevalence of peanut allergy after 60 months was 13.7% in the avoidance cohort and 1.9% in the consumption cohort (P < .001). Of 98 children who had positive skin-prick test results, 35% of the avoidance cohort had peanut allergy after 60 months, while only 11% of the consumption cohort had the allergy (P = .004). Several children who were initially enrolled and randomized either dropped out or were excluded because of inadequate adherence to treatment or missing data.

Outcomes were measured by placing children in a double-blind, placebo-controlled study that had them consume a cumulative total of 9.4 g of peanut protein to determine whether or not tolerance to peanuts had been effectively induced. All children consumed peanuts by eating peanut butter or a peanut-based snack called Bamba, which was provided for the study at a discounted rate. Children whose skin-prick tests showed wheals of larger than 4 mm in diameter were excluded for presumed existing peanut allergy.

“If you enroll children after 11 months of age, you get about twice the rate of [already allergic] children, with a steady decline as [age] goes down,” corresponding author Dr. Gideon Lack, head of the department of pediatric allergy at King’s College, London, said in a press conference following presentation of the study. “But of children younger than 5 months of age, none of them were peanut allergic, so that would suggest that timing here is key: There is a narrow window of opportunity to intervene if you want to be effective.”

Investigators also noted that children who consumed peanuts had increased levels of IgG4 antibody, while those told to avoid peanuts had higher levels of IgE antibody. They also found that development of peanut allergy was generally associated with subjects who both displayed larger wheals on the skin-prick test and had a lower ratio of IgG4:IgE antibodies. Skin-prick tests that yielded wheals of 1-2 mm in diameter were considered indicative of early risk for peanut allergy.

There was no significant difference in the rates of adverse events or hospitalizations between the consumption and avoidance cohort, but 99% of subjects in each group did experience at least one adverse event: 4,527 in the consumption cohort and 4,287 in the avoidance cohort (P = .02). Infants who consumed peanuts had higher instances of upper respiratory tract infection, viral skin infection, gastroenteritis, urticaria, and conjunctivitis, but events mostly ranged from mild to moderate and their severity was not significantly different from similar incidents reported in the avoidance cohort.

Hospitalization rates also were low, with 52 children in the avoidance cohort and 50 children who consumed peanuts being admitted over the study interval, or 16.2% and 15.7%, respectively (P = .86). Rates of serious adverse effects also were not significantly different between the two cohorts, with 101 children who avoided peanuts and 89 who consumed peanuts experiencing such events (P = .41).

Adequate adherence to treatment for the children randomized into the peanut-avoidance group was defined as eating less than 0.2 g of peanut protein on any single occasion and no more than 0.5 g over the course of a single week in the first 24 months of life. For children in the consumption cohort, adequate adherence meant consuming at least 2 g of peanut protein on at least one occasion in both the first and second years of life, and at least 3 g of peanut protein weekly for at least half the number of weeks for which data was collected.

“Whether or not these benefits can be sustained, we will find out in 1 year,” Dr. Lack said, adding that “all the children who had been consuming peanut have stopped [for] 1 year, and we will see if peanut allergy persists after 1 year of cessation of consumption.” He predicted that the findings would most likely produce a mixed response, with some children relapsing while others maintain sustained tolerance.

The LEAP study was supported by grants from the National Institute of Allergy and Infectious Diseases, Food Allergy and Research Education, the Medical Research Council and Asthma UK, the UK Department of Health’s National Institute for Health Research, the National Peanut Board, and the UK Food Standards Agency. Dr. Lack disclosed financial affiliations with DBV Technologies, and coauthor Dr. Helen Brough disclosed receiving financial support from Fare and Action Medical Research, along with study materials from Stallergenes, Thermo Scientific, and Meridian Foods.

[email protected]

HOUSTON – A peanut protein–bearing skin patch showed considerable promise in the largest randomized trial to date of any potential treatment for peanut allergy.

One year of treatment with the investigational proprietary Viaskin Peanut skin patch raised the threshold of exposure to peanut protein required to elicit an allergic reaction to a level that patients and families would consider life changing, Dr. Hugh A. Sampson said at the annual meeting of the American Academy of Allergy, Asthma, and Immunology.

“One of the biggest problems for the family of a patient with peanut allergy is the fear of getting contamination. If they could rest assured that they could tolerate something like a gram’s worth of contamination with peanut protein, much of that concern would go away. They could go to restaurants and birthday parties. They still need to be vigilant and tell people they’re peanut allergic, but the chance of these low-level contaminations that lead to most of the reactions we see would largely be taken care of,” said Dr. Sampson, professor of pediatrics, allergy, and immunology and dean for translational biomedical research at Icahn School of Medicine at Mount Sinai, New York.

He presented the findings of a phase IIb randomized, double-blind, multinational, placebo-controlled trial of what is being called epicutaneous immunotherapy. The trial involved 221 subjects with documented peanut allergy. Roughly half were aged 6-11 years; the rest were adolescents and adults up to age 55. They were randomized to one of four study arms: the skin patch at a dose of 50, 100, or 250 mcg or a placebo patch. As a requirement for study participation, all subjects had to have a peanut protein reaction–eliciting dose of 300 mg or less on baseline formal oral peanut challenge testing; half of the children reacted to 30 mg or less.

The primary endpoint was the ability to tolerate on a repeat oral challenge at 1 year either at least 1 g of peanut protein or 10 times the amount they tolerated on baseline testing. In the overall study population, the 250-mcg patch was the top performer. It was the only patch dose significantly better than placebo: 50% of all patients on the 250-mcg patch met the primary endpoint, compared with 25% of placebo-treated controls.

Peanut allergy typically starts early in life, so it’s noteworthy that the children in the study had a markedly more robust response to epicutaneous immunotherapy than the older patients. Indeed, among the 6- to 11-year-olds, all three patch doses outperformed placebo. The mean cumulative dose of peanut protein required to elicit a reaction on structured oral challenge testing was 1,121 mg greater at 1 year than at baseline among children on the 250-mcg patch, 570 mg greater with the 100-mcg patch, and 471 mg greater than at baseline among those using the 50-mcg patch.

Similarly, a robust dose-dependent increase was seen in protective peanut-specific IgG4 levels in response to 1 year of epicutaneous immunotherapy. The median level of this biomarker of therapeutic benefit climbed 19-fold over baseline in children on the 250-mcg patch, 7-fold with the 100-mcg patch, and 5.5-fold with the 50-mcg patch.

The compliance rate with patch therapy was greater than 96%. Only 2 of the 221 participants dropped out of the study due to adverse events, both because of a flare of atopic dermatitis around the patch site. There were no serious adverse events in the study.

The trial is being extended for a second year of immunotherapy. “My anticipation based on what we see with other forms of immunotherapy is that we might very well see even more protection,” according to Dr. Sampson.

In an interview, he said he’d like to see the skin patch studied at doses above 250 mcg in adolescents and adults.

“I would also love to see epicutaneous immunotherapy looked at in very young children,” he added. “You get a much better response, and it may be longer lasting because we think that the immune system in an infant is much more plastic than it is once they get older. Trying to reverse a set response is much more difficult.”

The skin patch is about the size of a small, round Band-Aid. It is placed over the back or inner upper arm and changed daily. The concept is that as humidity develops under the patch, a small amount of peanut protein permeates the outer skin. Langerhans cells then pick it up and transport it to regional lymph nodes, where T cells can activate desensitization.

“I think this concept of using a low amount of protein in a convenient, safe way could change the way we do immunotherapy,” Dr. Sampson predicted.

Asked to comment, peanut allergy researcher Dr. Brian P. Vickery of the University of North Carolina, Chapel Hill, agreed with Dr. Sampson’s assessment that patch therapy could be a game changer, especially given that there is no FDA-approved treatment for peanut allergy.

“Right now the standard of care is avoidance. So anything that improves upon that to allow a margin of safety that lets a patient get along in the world with the reassurance that a contamination event up to, say, a gram would be well tolerated would be transformative,” he said.

[email protected]

HOUSTON – A peanut protein–bearing skin patch showed considerable promise in the largest randomized trial to date of any potential treatment for peanut allergy.

One year of treatment with the investigational proprietary Viaskin Peanut skin patch raised the threshold of exposure to peanut protein required to elicit an allergic reaction to a level that patients and families would consider life changing, Dr. Hugh A. Sampson said at the annual meeting of the American Academy of Allergy, Asthma, and Immunology.

“One of the biggest problems for the family of a patient with peanut allergy is the fear of getting contamination. If they could rest assured that they could tolerate something like a gram’s worth of contamination with peanut protein, much of that concern would go away. They could go to restaurants and birthday parties. They still need to be vigilant and tell people they’re peanut allergic, but the chance of these low-level contaminations that lead to most of the reactions we see would largely be taken care of,” said Dr. Sampson, professor of pediatrics, allergy, and immunology and dean for translational biomedical research at Icahn School of Medicine at Mount Sinai, New York.

He presented the findings of a phase IIb randomized, double-blind, multinational, placebo-controlled trial of what is being called epicutaneous immunotherapy. The trial involved 221 subjects with documented peanut allergy. Roughly half were aged 6-11 years; the rest were adolescents and adults up to age 55. They were randomized to one of four study arms: the skin patch at a dose of 50, 100, or 250 mcg or a placebo patch. As a requirement for study participation, all subjects had to have a peanut protein reaction–eliciting dose of 300 mg or less on baseline formal oral peanut challenge testing; half of the children reacted to 30 mg or less.

The primary endpoint was the ability to tolerate on a repeat oral challenge at 1 year either at least 1 g of peanut protein or 10 times the amount they tolerated on baseline testing. In the overall study population, the 250-mcg patch was the top performer. It was the only patch dose significantly better than placebo: 50% of all patients on the 250-mcg patch met the primary endpoint, compared with 25% of placebo-treated controls.

Peanut allergy typically starts early in life, so it’s noteworthy that the children in the study had a markedly more robust response to epicutaneous immunotherapy than the older patients. Indeed, among the 6- to 11-year-olds, all three patch doses outperformed placebo. The mean cumulative dose of peanut protein required to elicit a reaction on structured oral challenge testing was 1,121 mg greater at 1 year than at baseline among children on the 250-mcg patch, 570 mg greater with the 100-mcg patch, and 471 mg greater than at baseline among those using the 50-mcg patch.

Similarly, a robust dose-dependent increase was seen in protective peanut-specific IgG4 levels in response to 1 year of epicutaneous immunotherapy. The median level of this biomarker of therapeutic benefit climbed 19-fold over baseline in children on the 250-mcg patch, 7-fold with the 100-mcg patch, and 5.5-fold with the 50-mcg patch.

The compliance rate with patch therapy was greater than 96%. Only 2 of the 221 participants dropped out of the study due to adverse events, both because of a flare of atopic dermatitis around the patch site. There were no serious adverse events in the study.

The trial is being extended for a second year of immunotherapy. “My anticipation based on what we see with other forms of immunotherapy is that we might very well see even more protection,” according to Dr. Sampson.

In an interview, he said he’d like to see the skin patch studied at doses above 250 mcg in adolescents and adults.

“I would also love to see epicutaneous immunotherapy looked at in very young children,” he added. “You get a much better response, and it may be longer lasting because we think that the immune system in an infant is much more plastic than it is once they get older. Trying to reverse a set response is much more difficult.”

The skin patch is about the size of a small, round Band-Aid. It is placed over the back or inner upper arm and changed daily. The concept is that as humidity develops under the patch, a small amount of peanut protein permeates the outer skin. Langerhans cells then pick it up and transport it to regional lymph nodes, where T cells can activate desensitization.

“I think this concept of using a low amount of protein in a convenient, safe way could change the way we do immunotherapy,” Dr. Sampson predicted.

Asked to comment, peanut allergy researcher Dr. Brian P. Vickery of the University of North Carolina, Chapel Hill, agreed with Dr. Sampson’s assessment that patch therapy could be a game changer, especially given that there is no FDA-approved treatment for peanut allergy.

“Right now the standard of care is avoidance. So anything that improves upon that to allow a margin of safety that lets a patient get along in the world with the reassurance that a contamination event up to, say, a gram would be well tolerated would be transformative,” he said.

[email protected]

HOUSTON – A peanut protein–bearing skin patch showed considerable promise in the largest randomized trial to date of any potential treatment for peanut allergy.

One year of treatment with the investigational proprietary Viaskin Peanut skin patch raised the threshold of exposure to peanut protein required to elicit an allergic reaction to a level that patients and families would consider life changing, Dr. Hugh A. Sampson said at the annual meeting of the American Academy of Allergy, Asthma, and Immunology.

“One of the biggest problems for the family of a patient with peanut allergy is the fear of getting contamination. If they could rest assured that they could tolerate something like a gram’s worth of contamination with peanut protein, much of that concern would go away. They could go to restaurants and birthday parties. They still need to be vigilant and tell people they’re peanut allergic, but the chance of these low-level contaminations that lead to most of the reactions we see would largely be taken care of,” said Dr. Sampson, professor of pediatrics, allergy, and immunology and dean for translational biomedical research at Icahn School of Medicine at Mount Sinai, New York.

He presented the findings of a phase IIb randomized, double-blind, multinational, placebo-controlled trial of what is being called epicutaneous immunotherapy. The trial involved 221 subjects with documented peanut allergy. Roughly half were aged 6-11 years; the rest were adolescents and adults up to age 55. They were randomized to one of four study arms: the skin patch at a dose of 50, 100, or 250 mcg or a placebo patch. As a requirement for study participation, all subjects had to have a peanut protein reaction–eliciting dose of 300 mg or less on baseline formal oral peanut challenge testing; half of the children reacted to 30 mg or less.

The primary endpoint was the ability to tolerate on a repeat oral challenge at 1 year either at least 1 g of peanut protein or 10 times the amount they tolerated on baseline testing. In the overall study population, the 250-mcg patch was the top performer. It was the only patch dose significantly better than placebo: 50% of all patients on the 250-mcg patch met the primary endpoint, compared with 25% of placebo-treated controls.

Peanut allergy typically starts early in life, so it’s noteworthy that the children in the study had a markedly more robust response to epicutaneous immunotherapy than the older patients. Indeed, among the 6- to 11-year-olds, all three patch doses outperformed placebo. The mean cumulative dose of peanut protein required to elicit a reaction on structured oral challenge testing was 1,121 mg greater at 1 year than at baseline among children on the 250-mcg patch, 570 mg greater with the 100-mcg patch, and 471 mg greater than at baseline among those using the 50-mcg patch.

Similarly, a robust dose-dependent increase was seen in protective peanut-specific IgG4 levels in response to 1 year of epicutaneous immunotherapy. The median level of this biomarker of therapeutic benefit climbed 19-fold over baseline in children on the 250-mcg patch, 7-fold with the 100-mcg patch, and 5.5-fold with the 50-mcg patch.

The compliance rate with patch therapy was greater than 96%. Only 2 of the 221 participants dropped out of the study due to adverse events, both because of a flare of atopic dermatitis around the patch site. There were no serious adverse events in the study.

The trial is being extended for a second year of immunotherapy. “My anticipation based on what we see with other forms of immunotherapy is that we might very well see even more protection,” according to Dr. Sampson.

In an interview, he said he’d like to see the skin patch studied at doses above 250 mcg in adolescents and adults.

“I would also love to see epicutaneous immunotherapy looked at in very young children,” he added. “You get a much better response, and it may be longer lasting because we think that the immune system in an infant is much more plastic than it is once they get older. Trying to reverse a set response is much more difficult.”

The skin patch is about the size of a small, round Band-Aid. It is placed over the back or inner upper arm and changed daily. The concept is that as humidity develops under the patch, a small amount of peanut protein permeates the outer skin. Langerhans cells then pick it up and transport it to regional lymph nodes, where T cells can activate desensitization.

“I think this concept of using a low amount of protein in a convenient, safe way could change the way we do immunotherapy,” Dr. Sampson predicted.

Asked to comment, peanut allergy researcher Dr. Brian P. Vickery of the University of North Carolina, Chapel Hill, agreed with Dr. Sampson’s assessment that patch therapy could be a game changer, especially given that there is no FDA-approved treatment for peanut allergy.

“Right now the standard of care is avoidance. So anything that improves upon that to allow a margin of safety that lets a patient get along in the world with the reassurance that a contamination event up to, say, a gram would be well tolerated would be transformative,” he said.

[email protected]