Porokeratosis of Mibelli (PM) is a lesion characterized by a surrounding cornoid lamella with variable nonspecific findings (eg, atrophy, acanthosis, verrucous hyperplasia) in the center of the lesion that typically presents in infancy to early childhood.¹ We report a case of PM in which a prior biopsy from the center of the lesion demonstrated papulosquamous dermatitis. We propose a 3-step technique to ensure proper orientation of a punch biopsy in cases of suspected PM.

Case Report

A 3-year-old girl presented with an erythematous, hypopigmented, scaling plaque on the posterior aspect of the left ankle surrounded by a hard rim. The plaque was first noted at 12 months of age and had slowly enlarged as the patient grew. Six months prior, a biopsy from the center of the lesion performed at another facility demonstrated a papulosquamous dermatitis.

Physical examination revealed a lesion that was 4.2-cm long, 2.2-cm wide at the superior pole, and 3.5-cm wide at the inferior pole (Figure 1). A line was drawn with a skin marker perpendicular to the rim of the lesion (Figure 2A) and a 6-mm punch biopsy was performed, centered at the intersection of the drawn line and the cornoid lamella (Figure 2B). The tissue was then bisected at the bedside along the skin marker line with a #15 blade (Figure 2C) and submitted in formalin for histologic processing. Histologic examination revealed an invagination of the epidermis producing a tier of parakeratotic cells with its apex pointed away from the center of the lesion. Dyskeratotic cells were noted at the base of the parakeratosis (Figure 3). Verrucous hyperplasia was present in the central portion of the specimen adjacent to the cornoid lamella. Based on these histopathologic findings, the correct diagnosis of PM was made.

Comment

Porokeratosis of Mibelli is a rare condition that typically presents in infancy to early childhood.¹ It may appear as small keratotic papules or larger plaques that reach several centimeters in diameter.² There is a 7.5% risk for malignant transformation (eg, basal cell carcinoma, squamous cell carcinoma, Bowen disease).³ Variable nonspecific findings (eg, atrophy, acanthosis, verrucous hyperplasia) typically are present in the center of the lesion. In our case, a biopsy from the center of the plaque demonstrated verrucous hyperplasia. The incorrect diagnosis of PM as psoriasis also has been reported.⁴

We propose a 3-step technique to ensure proper orientation of a punch biopsy in cases of suspected PM. First, draw a line perpendicular to the rim of the lesion to mark the biopsy site (Figure 2A). Second, perform a punch biopsy centered at the intersection of the drawn line and the cornoid lamella (Figure 2B). Third, section the biopsied tissue with a #15 blade along the perpendicular line at the bedside (Figure 2C). The surgical pathology requisition should mention that the specimen has been transected and the cut edges should be placed down in the cassette, ensuring that the cornoid lamella will be present in cross-section on the slides.

If the punch biopsy specimen is not bisected, it can be difficult to orient it in the pathology laboratory, especially if the cornoid lamellae are not prominent. Furthermore, the technician processing the tissue may not be aware of the importance of sectioning the specimen perpendicular to the cornoid lamella. Following this procedure, diagnosis can be confirmed in virtually every case of PM.

Porokeratosis of Mibelli (PM) is a lesion characterized by a surrounding cornoid lamella with variable nonspecific findings (eg, atrophy, acanthosis, verrucous hyperplasia) in the center of the lesion that typically presents in infancy to early childhood.¹ We report a case of PM in which a prior biopsy from the center of the lesion demonstrated papulosquamous dermatitis. We propose a 3-step technique to ensure proper orientation of a punch biopsy in cases of suspected PM.

Case Report

A 3-year-old girl presented with an erythematous, hypopigmented, scaling plaque on the posterior aspect of the left ankle surrounded by a hard rim. The plaque was first noted at 12 months of age and had slowly enlarged as the patient grew. Six months prior, a biopsy from the center of the lesion performed at another facility demonstrated a papulosquamous dermatitis.

Physical examination revealed a lesion that was 4.2-cm long, 2.2-cm wide at the superior pole, and 3.5-cm wide at the inferior pole (Figure 1). A line was drawn with a skin marker perpendicular to the rim of the lesion (Figure 2A) and a 6-mm punch biopsy was performed, centered at the intersection of the drawn line and the cornoid lamella (Figure 2B). The tissue was then bisected at the bedside along the skin marker line with a #15 blade (Figure 2C) and submitted in formalin for histologic processing. Histologic examination revealed an invagination of the epidermis producing a tier of parakeratotic cells with its apex pointed away from the center of the lesion. Dyskeratotic cells were noted at the base of the parakeratosis (Figure 3). Verrucous hyperplasia was present in the central portion of the specimen adjacent to the cornoid lamella. Based on these histopathologic findings, the correct diagnosis of PM was made.

Comment

Porokeratosis of Mibelli is a rare condition that typically presents in infancy to early childhood.¹ It may appear as small keratotic papules or larger plaques that reach several centimeters in diameter.² There is a 7.5% risk for malignant transformation (eg, basal cell carcinoma, squamous cell carcinoma, Bowen disease).³ Variable nonspecific findings (eg, atrophy, acanthosis, verrucous hyperplasia) typically are present in the center of the lesion. In our case, a biopsy from the center of the plaque demonstrated verrucous hyperplasia. The incorrect diagnosis of PM as psoriasis also has been reported.⁴

We propose a 3-step technique to ensure proper orientation of a punch biopsy in cases of suspected PM. First, draw a line perpendicular to the rim of the lesion to mark the biopsy site (Figure 2A). Second, perform a punch biopsy centered at the intersection of the drawn line and the cornoid lamella (Figure 2B). Third, section the biopsied tissue with a #15 blade along the perpendicular line at the bedside (Figure 2C). The surgical pathology requisition should mention that the specimen has been transected and the cut edges should be placed down in the cassette, ensuring that the cornoid lamella will be present in cross-section on the slides.

If the punch biopsy specimen is not bisected, it can be difficult to orient it in the pathology laboratory, especially if the cornoid lamellae are not prominent. Furthermore, the technician processing the tissue may not be aware of the importance of sectioning the specimen perpendicular to the cornoid lamella. Following this procedure, diagnosis can be confirmed in virtually every case of PM.

Porokeratosis of Mibelli (PM) is a lesion characterized by a surrounding cornoid lamella with variable nonspecific findings (eg, atrophy, acanthosis, verrucous hyperplasia) in the center of the lesion that typically presents in infancy to early childhood.¹ We report a case of PM in which a prior biopsy from the center of the lesion demonstrated papulosquamous dermatitis. We propose a 3-step technique to ensure proper orientation of a punch biopsy in cases of suspected PM.

Case Report

A 3-year-old girl presented with an erythematous, hypopigmented, scaling plaque on the posterior aspect of the left ankle surrounded by a hard rim. The plaque was first noted at 12 months of age and had slowly enlarged as the patient grew. Six months prior, a biopsy from the center of the lesion performed at another facility demonstrated a papulosquamous dermatitis.

Physical examination revealed a lesion that was 4.2-cm long, 2.2-cm wide at the superior pole, and 3.5-cm wide at the inferior pole (Figure 1). A line was drawn with a skin marker perpendicular to the rim of the lesion (Figure 2A) and a 6-mm punch biopsy was performed, centered at the intersection of the drawn line and the cornoid lamella (Figure 2B). The tissue was then bisected at the bedside along the skin marker line with a #15 blade (Figure 2C) and submitted in formalin for histologic processing. Histologic examination revealed an invagination of the epidermis producing a tier of parakeratotic cells with its apex pointed away from the center of the lesion. Dyskeratotic cells were noted at the base of the parakeratosis (Figure 3). Verrucous hyperplasia was present in the central portion of the specimen adjacent to the cornoid lamella. Based on these histopathologic findings, the correct diagnosis of PM was made.

Comment

Porokeratosis of Mibelli is a rare condition that typically presents in infancy to early childhood.¹ It may appear as small keratotic papules or larger plaques that reach several centimeters in diameter.² There is a 7.5% risk for malignant transformation (eg, basal cell carcinoma, squamous cell carcinoma, Bowen disease).³ Variable nonspecific findings (eg, atrophy, acanthosis, verrucous hyperplasia) typically are present in the center of the lesion. In our case, a biopsy from the center of the plaque demonstrated verrucous hyperplasia. The incorrect diagnosis of PM as psoriasis also has been reported.⁴

We propose a 3-step technique to ensure proper orientation of a punch biopsy in cases of suspected PM. First, draw a line perpendicular to the rim of the lesion to mark the biopsy site (Figure 2A). Second, perform a punch biopsy centered at the intersection of the drawn line and the cornoid lamella (Figure 2B). Third, section the biopsied tissue with a #15 blade along the perpendicular line at the bedside (Figure 2C). The surgical pathology requisition should mention that the specimen has been transected and the cut edges should be placed down in the cassette, ensuring that the cornoid lamella will be present in cross-section on the slides.

If the punch biopsy specimen is not bisected, it can be difficult to orient it in the pathology laboratory, especially if the cornoid lamellae are not prominent. Furthermore, the technician processing the tissue may not be aware of the importance of sectioning the specimen perpendicular to the cornoid lamella. Following this procedure, diagnosis can be confirmed in virtually every case of PM.

Physicians Nasim Afsar, MD, SFHM, and Eric Howell, MD, SFHM, presented key leadership lessons to a standing-room-only audience at Hospital Medicine 2016, the “Year of the Hospitalist.” The value of leadership and management skills is important in every day decisions from co-management of patients to motivating your teams.

Dr. Afsar and Dr. Howell went into detailed tips for these leadership lessons:

1. Decision-making bias. It is important to be aware of bias in decisions. A technique to evaluate a decision and “de-bias” is the WRAP process: Widen your options, Reality-test your assumptions, Attain distance before deciding, and Prepare to be wrong.
2. Performance management. Feedback and 360 evaluations are helpful tools in appraising performance.
3. Motivation can be intrinsic or extrinsic. Intrinsic motivation is essential for non-routine high level work in medicine. Understanding the motivation of a team member is very useful to the team leader.
4. Groups versus teams. The composition of a team is crucial to success. It is also important to be aware of team limitations and plan for these potential limitations.
5. Persuasion and influence. Six principles of persuasion are:

1. Demonstrate trustworthiness and expertise.
2. Social proof. Highlight existing norms or set new norms.
3. Highlight similarities.
4. A win-win situation with concessions shows willingness to participate.
5. Reach agreement.
6. An option that appears to be a rare offer is more desirable.

Key Takeaways

• Consistently using a standard decision-making process, such as WRAP, can ensure better decision making.
• Financial compensation can be detrimental to intrinsic motivation and worsen performance.
• Make a conscious decision about when you need a group to help make decisions versus a team to work towards a common goal.
• Set specific goals for performance during feedback: include timeline, particular actions, and results that are expected.
• Social proof can be a powerful tool in persuasion.
• The SHM Leadership Academy is available to hospitalists interested in expanding leadership skills. TH

Dr. Hale is a pediatric hospitalist at Floating Hospital for Children at Tufts University Medical Center in Boston, and a former member of Team Hospitalist.

Physicians Nasim Afsar, MD, SFHM, and Eric Howell, MD, SFHM, presented key leadership lessons to a standing-room-only audience at Hospital Medicine 2016, the “Year of the Hospitalist.” The value of leadership and management skills is important in every day decisions from co-management of patients to motivating your teams.

Dr. Afsar and Dr. Howell went into detailed tips for these leadership lessons:

1. Decision-making bias. It is important to be aware of bias in decisions. A technique to evaluate a decision and “de-bias” is the WRAP process: Widen your options, Reality-test your assumptions, Attain distance before deciding, and Prepare to be wrong.
2. Performance management. Feedback and 360 evaluations are helpful tools in appraising performance.
3. Motivation can be intrinsic or extrinsic. Intrinsic motivation is essential for non-routine high level work in medicine. Understanding the motivation of a team member is very useful to the team leader.
4. Groups versus teams. The composition of a team is crucial to success. It is also important to be aware of team limitations and plan for these potential limitations.
5. Persuasion and influence. Six principles of persuasion are:

1. Demonstrate trustworthiness and expertise.
2. Social proof. Highlight existing norms or set new norms.
3. Highlight similarities.
4. A win-win situation with concessions shows willingness to participate.
5. Reach agreement.
6. An option that appears to be a rare offer is more desirable.

Key Takeaways

• Consistently using a standard decision-making process, such as WRAP, can ensure better decision making.
• Financial compensation can be detrimental to intrinsic motivation and worsen performance.
• Make a conscious decision about when you need a group to help make decisions versus a team to work towards a common goal.
• Set specific goals for performance during feedback: include timeline, particular actions, and results that are expected.
• Social proof can be a powerful tool in persuasion.
• The SHM Leadership Academy is available to hospitalists interested in expanding leadership skills. TH

Dr. Hale is a pediatric hospitalist at Floating Hospital for Children at Tufts University Medical Center in Boston, and a former member of Team Hospitalist.

Physicians Nasim Afsar, MD, SFHM, and Eric Howell, MD, SFHM, presented key leadership lessons to a standing-room-only audience at Hospital Medicine 2016, the “Year of the Hospitalist.” The value of leadership and management skills is important in every day decisions from co-management of patients to motivating your teams.

Dr. Afsar and Dr. Howell went into detailed tips for these leadership lessons:

1. Decision-making bias. It is important to be aware of bias in decisions. A technique to evaluate a decision and “de-bias” is the WRAP process: Widen your options, Reality-test your assumptions, Attain distance before deciding, and Prepare to be wrong.
2. Performance management. Feedback and 360 evaluations are helpful tools in appraising performance.
3. Motivation can be intrinsic or extrinsic. Intrinsic motivation is essential for non-routine high level work in medicine. Understanding the motivation of a team member is very useful to the team leader.
4. Groups versus teams. The composition of a team is crucial to success. It is also important to be aware of team limitations and plan for these potential limitations.
5. Persuasion and influence. Six principles of persuasion are:

1. Demonstrate trustworthiness and expertise.
2. Social proof. Highlight existing norms or set new norms.
3. Highlight similarities.
4. A win-win situation with concessions shows willingness to participate.
5. Reach agreement.
6. An option that appears to be a rare offer is more desirable.

Key Takeaways

• Consistently using a standard decision-making process, such as WRAP, can ensure better decision making.
• Financial compensation can be detrimental to intrinsic motivation and worsen performance.
• Make a conscious decision about when you need a group to help make decisions versus a team to work towards a common goal.
• Set specific goals for performance during feedback: include timeline, particular actions, and results that are expected.
• Social proof can be a powerful tool in persuasion.
• The SHM Leadership Academy is available to hospitalists interested in expanding leadership skills. TH

Dr. Hale is a pediatric hospitalist at Floating Hospital for Children at Tufts University Medical Center in Boston, and a former member of Team Hospitalist.

Dr. Vivek Murthy delivered an excellent opening address to Hospital Medicine 2016, the “Year of the Hospitalist.” He presented a key message that hospitalists can be major supporters of public health and disease prevention. He described the clean water crisis in Flint, Michigan as a tragedy that should not be occurring in the United States in the year 2016.

We need to renew our commitment to a strong foundation of public health. “Health is the key to opportunity,” Dr. Murthy stated. He reviewed four pillars for the foundation of good public health:

1. Make healthy choices a desired choice. We should try to establish exercise and good eating as a part of a normal lifestyle, not something onerous or difficult. Healthy choices can be a source of pleasure.
2. Change the environment to make healthy changes sustainable. The environment includes advertising and marketing of good choices, access to healthy foods, and access to increased activity. An example was local government commitments to increased walkable routes and parks will increase activity in a population.
3. Focus on the mind and spirit, not just the body.
4. Cultivate the ability to give and receive kindness.

Dr. Murthy left the hospitalist with three take-home questions:

1. Can a hospitalist leverage leadership to create a culture of healing?
2. Can a hospitalist be a force for change outside the hospital setting? Can you assist with nutrition wellness or safety projects outside of the hospital?
3. Can we inspire the next generation of physicians to work on public health and preventing illness?

Key Takeaways

1. Hospitalists can be major supporters of public health and disease prevention; and
2. The foundation of good public health includes the changes to make healthy choices a desired choice, change the environment to make healthy changes sustainable, focus on the mind and spirit, and cultivate the ability to give and receive kindness.

Dr. Vivek Murthy delivered an excellent opening address to Hospital Medicine 2016, the “Year of the Hospitalist.” He presented a key message that hospitalists can be major supporters of public health and disease prevention. He described the clean water crisis in Flint, Michigan as a tragedy that should not be occurring in the United States in the year 2016.

We need to renew our commitment to a strong foundation of public health. “Health is the key to opportunity,” Dr. Murthy stated. He reviewed four pillars for the foundation of good public health:

1. Make healthy choices a desired choice. We should try to establish exercise and good eating as a part of a normal lifestyle, not something onerous or difficult. Healthy choices can be a source of pleasure.
2. Change the environment to make healthy changes sustainable. The environment includes advertising and marketing of good choices, access to healthy foods, and access to increased activity. An example was local government commitments to increased walkable routes and parks will increase activity in a population.
3. Focus on the mind and spirit, not just the body.
4. Cultivate the ability to give and receive kindness.

Dr. Murthy left the hospitalist with three take-home questions:

1. Can a hospitalist leverage leadership to create a culture of healing?
2. Can a hospitalist be a force for change outside the hospital setting? Can you assist with nutrition wellness or safety projects outside of the hospital?
3. Can we inspire the next generation of physicians to work on public health and preventing illness?

Key Takeaways

1. Hospitalists can be major supporters of public health and disease prevention; and
2. The foundation of good public health includes the changes to make healthy choices a desired choice, change the environment to make healthy changes sustainable, focus on the mind and spirit, and cultivate the ability to give and receive kindness.

Dr. Vivek Murthy delivered an excellent opening address to Hospital Medicine 2016, the “Year of the Hospitalist.” He presented a key message that hospitalists can be major supporters of public health and disease prevention. He described the clean water crisis in Flint, Michigan as a tragedy that should not be occurring in the United States in the year 2016.

We need to renew our commitment to a strong foundation of public health. “Health is the key to opportunity,” Dr. Murthy stated. He reviewed four pillars for the foundation of good public health:

1. Make healthy choices a desired choice. We should try to establish exercise and good eating as a part of a normal lifestyle, not something onerous or difficult. Healthy choices can be a source of pleasure.
2. Change the environment to make healthy changes sustainable. The environment includes advertising and marketing of good choices, access to healthy foods, and access to increased activity. An example was local government commitments to increased walkable routes and parks will increase activity in a population.
3. Focus on the mind and spirit, not just the body.
4. Cultivate the ability to give and receive kindness.

Dr. Murthy left the hospitalist with three take-home questions:

1. Can a hospitalist leverage leadership to create a culture of healing?
2. Can a hospitalist be a force for change outside the hospital setting? Can you assist with nutrition wellness or safety projects outside of the hospital?
3. Can we inspire the next generation of physicians to work on public health and preventing illness?

Key Takeaways

1. Hospitalists can be major supporters of public health and disease prevention; and
2. The foundation of good public health includes the changes to make healthy choices a desired choice, change the environment to make healthy changes sustainable, focus on the mind and spirit, and cultivate the ability to give and receive kindness.

Presenter: Aziz Ansari, DO, FHM

Summary: With the implementation of ICD-10, correct and specific documentation to ensure proper patient diagnosis categorization has become increasingly important. Hospitalists are urged to understand the impact CDI has on quality and reimbursement.

Quality Impact: Documentation has a direct impact on quality reporting for mortality and complication rates, risk of mortality, as well as severity of illness. Documenting present on admission (POA) also directly impacts the hospital-acquired condition (HAC) classifications.

Reimbursement Impact: Documentation has a direct impact on expected length of stay, case mix index (CMI), cost reporting, and appropriate hospital reimbursement.

HM Takeaways:

• Be clear and specific.
• Document principle diagnosis and secondary diagnoses, and their associated interactions, are critically important.
• Ensure all diagnoses are a part of the discharge summary.
• Avoid saying “History of.”
• It’s OK to document “possible,” “probably,” “likely,” or “suspected.”
• Document “why” the patient has the diagnosis.
• List all differentials, and identify if ruled in or ruled out.
• Indicate acuity, even if obvious.

This presenter also reviewed common CDI opportunities in hospital medicine.

Note: This discussion was specific to the needs of the hospital patient diagnosis and billing, and not related to physician billing and CPT codes.

Presenter: Aziz Ansari, DO, FHM

Summary: With the implementation of ICD-10, correct and specific documentation to ensure proper patient diagnosis categorization has become increasingly important. Hospitalists are urged to understand the impact CDI has on quality and reimbursement.

Quality Impact: Documentation has a direct impact on quality reporting for mortality and complication rates, risk of mortality, as well as severity of illness. Documenting present on admission (POA) also directly impacts the hospital-acquired condition (HAC) classifications.

Reimbursement Impact: Documentation has a direct impact on expected length of stay, case mix index (CMI), cost reporting, and appropriate hospital reimbursement.

HM Takeaways:

• Be clear and specific.
• Document principle diagnosis and secondary diagnoses, and their associated interactions, are critically important.
• Ensure all diagnoses are a part of the discharge summary.
• Avoid saying “History of.”
• It’s OK to document “possible,” “probably,” “likely,” or “suspected.”
• Document “why” the patient has the diagnosis.
• List all differentials, and identify if ruled in or ruled out.
• Indicate acuity, even if obvious.

This presenter also reviewed common CDI opportunities in hospital medicine.

Note: This discussion was specific to the needs of the hospital patient diagnosis and billing, and not related to physician billing and CPT codes.

Presenter: Aziz Ansari, DO, FHM

Summary: With the implementation of ICD-10, correct and specific documentation to ensure proper patient diagnosis categorization has become increasingly important. Hospitalists are urged to understand the impact CDI has on quality and reimbursement.

Quality Impact: Documentation has a direct impact on quality reporting for mortality and complication rates, risk of mortality, as well as severity of illness. Documenting present on admission (POA) also directly impacts the hospital-acquired condition (HAC) classifications.

Reimbursement Impact: Documentation has a direct impact on expected length of stay, case mix index (CMI), cost reporting, and appropriate hospital reimbursement.

HM Takeaways:

• Be clear and specific.
• Document principle diagnosis and secondary diagnoses, and their associated interactions, are critically important.
• Ensure all diagnoses are a part of the discharge summary.
• Avoid saying “History of.”
• It’s OK to document “possible,” “probably,” “likely,” or “suspected.”
• Document “why” the patient has the diagnosis.
• List all differentials, and identify if ruled in or ruled out.
• Indicate acuity, even if obvious.

This presenter also reviewed common CDI opportunities in hospital medicine.

Note: This discussion was specific to the needs of the hospital patient diagnosis and billing, and not related to physician billing and CPT codes.

[WpProQuiz 5]

[WpProQuiz_toplist 5]

[WpProQuiz 5]

[WpProQuiz_toplist 5]

[WpProQuiz 5]

[WpProQuiz_toplist 5]

The recipient of the first uterus transplant performed in the United States is recovering well and looking forward to the next phase of the research project: pregnancy, according to the team of Cleveland Clinic surgeons who performed the groundbreaking Feb. 24 transplant.

“I’m pleased to report to you that our patient is doing very well,” lead surgeon Dr. Andreas G. Tzakis said during a press conference on March 7.

The transplant recipient, known only as “Lindsey” to protect her privacy, is a 26-year-old woman with uterine factor infertility (UFI). She was selected from among more than 250 applicants to undergo the 9-hour procedure involving transplantation of a uterus from a deceased organ donor of reproductive age. She is the first of 10 women set to undergo the procedure as part of the Cleveland Clinic study.

Courtesy of the Cleveland Clinic

“Lindsey” made an appearance at the press conference and expressed, first and foremost, her “immense gratitude” to the donor’s family.

“They have provided me with a gift that I will never be able to repay,” she said in an emotional statement in which she shared about learning at age 16 that she would never be able to have children.

“From that moment on I prayed that God would allow me the opportunity to experience pregnancy, and here we are today at the beginning of that journey,” she said.

Lindsey will undergo a year of anti-rejection treatment prior to undergoing in vitro fertilization; her eggs were previously fertilized using her husband’s sperm, and the embryos are in cryogenic storage, according to Dr. Rebecca Flyckt, another member of the surgical team.

The embryos will be transferred one by one until the goal of a healthy pregnancy and healthy baby delivered by cesarean section is achieved, Dr. Flyckt said.

After one or two successful pregnancies and births, the uterus will be removed. Although substantial evidence suggests that anti-rejection medications are relatively safe in pregnancy, minimizing and ultimately eliminating the need for them is advisable, thus uterus transplants, at least under the Cleveland Clinic research protocol, are meant to be temporary.

Uterus transplants are performed to enable patients – who have either lost their uterus to disease or who were born without a uterus or a functioning uterus – to experience pregnancy and childbirth.

Prior to the Cleveland Clinic transplant, nine had been performed successfully with healthy outcomes (the first post-transplant baby was born healthy in 2014). All were performed at the University of Gothenburg in Sweden. Dr. Tzakis traveled there to work with surgeons prior to performing the procedure at the Cleveland Clinic, where he is the Transplant Center program director.

Ethical issues

Addressing the bioethical issues surrounding uterine transplant was an important part of this project, according to team member Dr. Ruth Farrell, a bioethicist and ob.gyn. surgeon at the Cleveland Clinic.

“Despite the name uterine transplant, the focus of this procedure is not on the uterus. It’s on women and children and families,” she said, adding that to understand the ethical issues of uterine transplant, it’s important to consider the perspectives of women with UFI.

“For instance, women born without a uterus have a medical condition that affects every aspect of their lives, from the time they are diagnosed in adolescence, to when they are adults looking for relationships and trying to decide if and how to have a family,” she said, adding that “these women face the real possibility of never having children.”

But this advance in reproductive medicine and science also requires a close look at how the potential risks and benefits of uterine transplant weigh against existing options of adoption and surrogacy. While there are many successful stories involving surrogacy and adoption, these options are not available to all women because of “legal, cultural, religious, and other very personal reasons,” Dr. Farrell said.

“Our research on uterine transplant, we hope, may give women another option which may work better for them and their families,” she said, also noting that while living donor transplants have been performed, these come with some risk, thus deceased donors are being used for the current study.

Insurance coverage

As for the feasibility of uterine transplant, many questions remain to be answered, according to Dr. Tommaso Falcone, chair of the department of obstetrics and gynecology at the Cleveland Clinic, who said that the procedures done as part of the current study will be paid for by an institutional grant.

While the American Society for Reproductive Medicine contends that infertility is a disease worthy of insurance coverage, that is “outside of our hands,” he said.

Indeed, while this first uterine transplant in the United States is a “huge and exciting breakthrough,” and while “the folks at Cleveland Clinic should be congratulated,” the possibility of this procedure ever being covered by insurance and being available to women outside of the research protocol is questionable, especially given the available alternatives, such as gestational carriers and surrogacy, Dr. David A. Forstein, a reproductive endocrinologist at the University of South Carolina, Greenville, said in an interview.

In a patient-centered model, this “tremendous, wonderful gift from science” would give patients – like the 1 in 5,000 women in the United States who are born without a uterus – a very viable alternative, but the question is whether having one’s own children is a right, and whether extensive financial resources should be committed to helping women achieve that, he said.

Dr. Charles E. Miller, a reproductive endocrinologist in Chicago, and head of minimally invasive gynecologic surgery at Advocate Lutheran General Hospital in Park Ridge, Ill., agreed that this transplant is to be celebrated.

“It’s a big moment, to say the least,” he said in an interview.

But Dr. Miller also questioned the feasibility of the procedure and whether society will “look favorably upon donation,” given the availability of alternatives for which there is now great success.

“I salute the pioneering effort,” he said, “But at the end of the day, can society take on this burden of a procedure performed not to sustain life, but to help create life? That’s a tough one.”

[email protected]

The recipient of the first uterus transplant performed in the United States is recovering well and looking forward to the next phase of the research project: pregnancy, according to the team of Cleveland Clinic surgeons who performed the groundbreaking Feb. 24 transplant.

“I’m pleased to report to you that our patient is doing very well,” lead surgeon Dr. Andreas G. Tzakis said during a press conference on March 7.

The transplant recipient, known only as “Lindsey” to protect her privacy, is a 26-year-old woman with uterine factor infertility (UFI). She was selected from among more than 250 applicants to undergo the 9-hour procedure involving transplantation of a uterus from a deceased organ donor of reproductive age. She is the first of 10 women set to undergo the procedure as part of the Cleveland Clinic study.

Courtesy of the Cleveland Clinic

“Lindsey” made an appearance at the press conference and expressed, first and foremost, her “immense gratitude” to the donor’s family.

“They have provided me with a gift that I will never be able to repay,” she said in an emotional statement in which she shared about learning at age 16 that she would never be able to have children.

“From that moment on I prayed that God would allow me the opportunity to experience pregnancy, and here we are today at the beginning of that journey,” she said.

Lindsey will undergo a year of anti-rejection treatment prior to undergoing in vitro fertilization; her eggs were previously fertilized using her husband’s sperm, and the embryos are in cryogenic storage, according to Dr. Rebecca Flyckt, another member of the surgical team.

The embryos will be transferred one by one until the goal of a healthy pregnancy and healthy baby delivered by cesarean section is achieved, Dr. Flyckt said.

After one or two successful pregnancies and births, the uterus will be removed. Although substantial evidence suggests that anti-rejection medications are relatively safe in pregnancy, minimizing and ultimately eliminating the need for them is advisable, thus uterus transplants, at least under the Cleveland Clinic research protocol, are meant to be temporary.

Uterus transplants are performed to enable patients – who have either lost their uterus to disease or who were born without a uterus or a functioning uterus – to experience pregnancy and childbirth.

Prior to the Cleveland Clinic transplant, nine had been performed successfully with healthy outcomes (the first post-transplant baby was born healthy in 2014). All were performed at the University of Gothenburg in Sweden. Dr. Tzakis traveled there to work with surgeons prior to performing the procedure at the Cleveland Clinic, where he is the Transplant Center program director.

Ethical issues

Addressing the bioethical issues surrounding uterine transplant was an important part of this project, according to team member Dr. Ruth Farrell, a bioethicist and ob.gyn. surgeon at the Cleveland Clinic.

“Despite the name uterine transplant, the focus of this procedure is not on the uterus. It’s on women and children and families,” she said, adding that to understand the ethical issues of uterine transplant, it’s important to consider the perspectives of women with UFI.

“For instance, women born without a uterus have a medical condition that affects every aspect of their lives, from the time they are diagnosed in adolescence, to when they are adults looking for relationships and trying to decide if and how to have a family,” she said, adding that “these women face the real possibility of never having children.”

But this advance in reproductive medicine and science also requires a close look at how the potential risks and benefits of uterine transplant weigh against existing options of adoption and surrogacy. While there are many successful stories involving surrogacy and adoption, these options are not available to all women because of “legal, cultural, religious, and other very personal reasons,” Dr. Farrell said.

“Our research on uterine transplant, we hope, may give women another option which may work better for them and their families,” she said, also noting that while living donor transplants have been performed, these come with some risk, thus deceased donors are being used for the current study.

Insurance coverage

As for the feasibility of uterine transplant, many questions remain to be answered, according to Dr. Tommaso Falcone, chair of the department of obstetrics and gynecology at the Cleveland Clinic, who said that the procedures done as part of the current study will be paid for by an institutional grant.

While the American Society for Reproductive Medicine contends that infertility is a disease worthy of insurance coverage, that is “outside of our hands,” he said.

Indeed, while this first uterine transplant in the United States is a “huge and exciting breakthrough,” and while “the folks at Cleveland Clinic should be congratulated,” the possibility of this procedure ever being covered by insurance and being available to women outside of the research protocol is questionable, especially given the available alternatives, such as gestational carriers and surrogacy, Dr. David A. Forstein, a reproductive endocrinologist at the University of South Carolina, Greenville, said in an interview.

In a patient-centered model, this “tremendous, wonderful gift from science” would give patients – like the 1 in 5,000 women in the United States who are born without a uterus – a very viable alternative, but the question is whether having one’s own children is a right, and whether extensive financial resources should be committed to helping women achieve that, he said.

Dr. Charles E. Miller, a reproductive endocrinologist in Chicago, and head of minimally invasive gynecologic surgery at Advocate Lutheran General Hospital in Park Ridge, Ill., agreed that this transplant is to be celebrated.

“It’s a big moment, to say the least,” he said in an interview.

But Dr. Miller also questioned the feasibility of the procedure and whether society will “look favorably upon donation,” given the availability of alternatives for which there is now great success.

“I salute the pioneering effort,” he said, “But at the end of the day, can society take on this burden of a procedure performed not to sustain life, but to help create life? That’s a tough one.”

[email protected]

The recipient of the first uterus transplant performed in the United States is recovering well and looking forward to the next phase of the research project: pregnancy, according to the team of Cleveland Clinic surgeons who performed the groundbreaking Feb. 24 transplant.

“I’m pleased to report to you that our patient is doing very well,” lead surgeon Dr. Andreas G. Tzakis said during a press conference on March 7.

The transplant recipient, known only as “Lindsey” to protect her privacy, is a 26-year-old woman with uterine factor infertility (UFI). She was selected from among more than 250 applicants to undergo the 9-hour procedure involving transplantation of a uterus from a deceased organ donor of reproductive age. She is the first of 10 women set to undergo the procedure as part of the Cleveland Clinic study.

Courtesy of the Cleveland Clinic

“Lindsey” made an appearance at the press conference and expressed, first and foremost, her “immense gratitude” to the donor’s family.

“They have provided me with a gift that I will never be able to repay,” she said in an emotional statement in which she shared about learning at age 16 that she would never be able to have children.

“From that moment on I prayed that God would allow me the opportunity to experience pregnancy, and here we are today at the beginning of that journey,” she said.

Lindsey will undergo a year of anti-rejection treatment prior to undergoing in vitro fertilization; her eggs were previously fertilized using her husband’s sperm, and the embryos are in cryogenic storage, according to Dr. Rebecca Flyckt, another member of the surgical team.

The embryos will be transferred one by one until the goal of a healthy pregnancy and healthy baby delivered by cesarean section is achieved, Dr. Flyckt said.

After one or two successful pregnancies and births, the uterus will be removed. Although substantial evidence suggests that anti-rejection medications are relatively safe in pregnancy, minimizing and ultimately eliminating the need for them is advisable, thus uterus transplants, at least under the Cleveland Clinic research protocol, are meant to be temporary.

Uterus transplants are performed to enable patients – who have either lost their uterus to disease or who were born without a uterus or a functioning uterus – to experience pregnancy and childbirth.

Prior to the Cleveland Clinic transplant, nine had been performed successfully with healthy outcomes (the first post-transplant baby was born healthy in 2014). All were performed at the University of Gothenburg in Sweden. Dr. Tzakis traveled there to work with surgeons prior to performing the procedure at the Cleveland Clinic, where he is the Transplant Center program director.

Ethical issues

Addressing the bioethical issues surrounding uterine transplant was an important part of this project, according to team member Dr. Ruth Farrell, a bioethicist and ob.gyn. surgeon at the Cleveland Clinic.

“Despite the name uterine transplant, the focus of this procedure is not on the uterus. It’s on women and children and families,” she said, adding that to understand the ethical issues of uterine transplant, it’s important to consider the perspectives of women with UFI.

“For instance, women born without a uterus have a medical condition that affects every aspect of their lives, from the time they are diagnosed in adolescence, to when they are adults looking for relationships and trying to decide if and how to have a family,” she said, adding that “these women face the real possibility of never having children.”

But this advance in reproductive medicine and science also requires a close look at how the potential risks and benefits of uterine transplant weigh against existing options of adoption and surrogacy. While there are many successful stories involving surrogacy and adoption, these options are not available to all women because of “legal, cultural, religious, and other very personal reasons,” Dr. Farrell said.

“Our research on uterine transplant, we hope, may give women another option which may work better for them and their families,” she said, also noting that while living donor transplants have been performed, these come with some risk, thus deceased donors are being used for the current study.

Insurance coverage

As for the feasibility of uterine transplant, many questions remain to be answered, according to Dr. Tommaso Falcone, chair of the department of obstetrics and gynecology at the Cleveland Clinic, who said that the procedures done as part of the current study will be paid for by an institutional grant.

While the American Society for Reproductive Medicine contends that infertility is a disease worthy of insurance coverage, that is “outside of our hands,” he said.

Indeed, while this first uterine transplant in the United States is a “huge and exciting breakthrough,” and while “the folks at Cleveland Clinic should be congratulated,” the possibility of this procedure ever being covered by insurance and being available to women outside of the research protocol is questionable, especially given the available alternatives, such as gestational carriers and surrogacy, Dr. David A. Forstein, a reproductive endocrinologist at the University of South Carolina, Greenville, said in an interview.

In a patient-centered model, this “tremendous, wonderful gift from science” would give patients – like the 1 in 5,000 women in the United States who are born without a uterus – a very viable alternative, but the question is whether having one’s own children is a right, and whether extensive financial resources should be committed to helping women achieve that, he said.

Dr. Charles E. Miller, a reproductive endocrinologist in Chicago, and head of minimally invasive gynecologic surgery at Advocate Lutheran General Hospital in Park Ridge, Ill., agreed that this transplant is to be celebrated.

“It’s a big moment, to say the least,” he said in an interview.

But Dr. Miller also questioned the feasibility of the procedure and whether society will “look favorably upon donation,” given the availability of alternatives for which there is now great success.

“I salute the pioneering effort,” he said, “But at the end of the day, can society take on this burden of a procedure performed not to sustain life, but to help create life? That’s a tough one.”

[email protected]

The use of progression-free survival and response rate as surrogates for overall survival were supported by significant correlations between the endpoints, in randomized trials of advanced soft tissue sarcoma.

However, 3-month progression-free survival (PFS) and 6-month PFS were not significantly correlated with overall survival (OS) and were not recommended as surrogates for OS, according to the researchers.

Significant correlations were observed between overall survival and PFS (correlation coefficient, 0.61) and overall survival and response rate (0.51). Correlations between 3-month PFS and 6-month PFS with overall survival (0.27 and 0.31, respectively) were not significant.

“In soft tissue sarcoma, trial design is particularly challenging, owing to the rarity and heterogeneity of this disease. Time-based endpoints including PFS, 3-month PFS, and 6-month PFS are gaining popularity as primary endpoints in phase III RCTs [randomized controlled trials], despite the fact that current data support their use only to screen for effective drugs in phase II trials,” wrote Dr. Alona Zer of Princess Margaret Cancer Centre and the University of Toronto and colleagues (J Clin Oncol. 2016 March 7. Doi: 10.1200/JCO.2016.66.4581).

“Data show that the assessment of outcomes as a single point in time … only rarely mirrors the hazards of the same endpoint. … As such, the odds ratio for 3-month PFS or 6-month PFS likely do not approximate the hazard ratio for PFS, making it difficult to justify the use of these endpoints in definitive phase III trials.”

PFS and overall survival have shown poor correlation in other cancer types, and evidence suggests that survival post progression may influence the association, with weaker correlations at longer survival post progression. The majority of soft tissue sarcoma reports had survival post progression of less than 12 months, likely explaining the high correlation between PFS and overall survival.

The investigators performed a systematic review of 52 randomized controlled trials, published from 1974 to 2014, that included 9,762 patients who received systemic therapy for advanced/metastatic soft tissue sarcoma.

Comprehensive toxicity assessment was included in just 20 studies (47%) and poorly reported in 6 studies (14%). Few studies included quality of life as a secondary endpoint. The authors noted that in the soft tissue sarcoma setting in which the purpose of systemic treatment may be palliation of symptoms, this is a concern.

Over the 4 decades represented by the systematic review, several trends appeared. Overall, a low proportion of studies included intent-to-treat analyses and clearly defined primary endpoints, but these characteristics improved over time. Endpoint selection has shifted away from response rate in favor of time-based events, including PFS, 3-month PFS, and 6-month PFS. Overall survival was the primary endpoint in just 4% of studies. Studies published in the last 2 decades were more likely to be supported by industry (5% vs. 35%).

Dr. Zer and coauthors reported having no relevant financial disclosures.

The use of progression-free survival and response rate as surrogates for overall survival were supported by significant correlations between the endpoints, in randomized trials of advanced soft tissue sarcoma.

However, 3-month progression-free survival (PFS) and 6-month PFS were not significantly correlated with overall survival (OS) and were not recommended as surrogates for OS, according to the researchers.

Significant correlations were observed between overall survival and PFS (correlation coefficient, 0.61) and overall survival and response rate (0.51). Correlations between 3-month PFS and 6-month PFS with overall survival (0.27 and 0.31, respectively) were not significant.

“In soft tissue sarcoma, trial design is particularly challenging, owing to the rarity and heterogeneity of this disease. Time-based endpoints including PFS, 3-month PFS, and 6-month PFS are gaining popularity as primary endpoints in phase III RCTs [randomized controlled trials], despite the fact that current data support their use only to screen for effective drugs in phase II trials,” wrote Dr. Alona Zer of Princess Margaret Cancer Centre and the University of Toronto and colleagues (J Clin Oncol. 2016 March 7. Doi: 10.1200/JCO.2016.66.4581).

“Data show that the assessment of outcomes as a single point in time … only rarely mirrors the hazards of the same endpoint. … As such, the odds ratio for 3-month PFS or 6-month PFS likely do not approximate the hazard ratio for PFS, making it difficult to justify the use of these endpoints in definitive phase III trials.”

PFS and overall survival have shown poor correlation in other cancer types, and evidence suggests that survival post progression may influence the association, with weaker correlations at longer survival post progression. The majority of soft tissue sarcoma reports had survival post progression of less than 12 months, likely explaining the high correlation between PFS and overall survival.

The investigators performed a systematic review of 52 randomized controlled trials, published from 1974 to 2014, that included 9,762 patients who received systemic therapy for advanced/metastatic soft tissue sarcoma.

Comprehensive toxicity assessment was included in just 20 studies (47%) and poorly reported in 6 studies (14%). Few studies included quality of life as a secondary endpoint. The authors noted that in the soft tissue sarcoma setting in which the purpose of systemic treatment may be palliation of symptoms, this is a concern.

Over the 4 decades represented by the systematic review, several trends appeared. Overall, a low proportion of studies included intent-to-treat analyses and clearly defined primary endpoints, but these characteristics improved over time. Endpoint selection has shifted away from response rate in favor of time-based events, including PFS, 3-month PFS, and 6-month PFS. Overall survival was the primary endpoint in just 4% of studies. Studies published in the last 2 decades were more likely to be supported by industry (5% vs. 35%).

Dr. Zer and coauthors reported having no relevant financial disclosures.

The use of progression-free survival and response rate as surrogates for overall survival were supported by significant correlations between the endpoints, in randomized trials of advanced soft tissue sarcoma.

However, 3-month progression-free survival (PFS) and 6-month PFS were not significantly correlated with overall survival (OS) and were not recommended as surrogates for OS, according to the researchers.

Significant correlations were observed between overall survival and PFS (correlation coefficient, 0.61) and overall survival and response rate (0.51). Correlations between 3-month PFS and 6-month PFS with overall survival (0.27 and 0.31, respectively) were not significant.

“In soft tissue sarcoma, trial design is particularly challenging, owing to the rarity and heterogeneity of this disease. Time-based endpoints including PFS, 3-month PFS, and 6-month PFS are gaining popularity as primary endpoints in phase III RCTs [randomized controlled trials], despite the fact that current data support their use only to screen for effective drugs in phase II trials,” wrote Dr. Alona Zer of Princess Margaret Cancer Centre and the University of Toronto and colleagues (J Clin Oncol. 2016 March 7. Doi: 10.1200/JCO.2016.66.4581).

“Data show that the assessment of outcomes as a single point in time … only rarely mirrors the hazards of the same endpoint. … As such, the odds ratio for 3-month PFS or 6-month PFS likely do not approximate the hazard ratio for PFS, making it difficult to justify the use of these endpoints in definitive phase III trials.”

PFS and overall survival have shown poor correlation in other cancer types, and evidence suggests that survival post progression may influence the association, with weaker correlations at longer survival post progression. The majority of soft tissue sarcoma reports had survival post progression of less than 12 months, likely explaining the high correlation between PFS and overall survival.

The investigators performed a systematic review of 52 randomized controlled trials, published from 1974 to 2014, that included 9,762 patients who received systemic therapy for advanced/metastatic soft tissue sarcoma.

Comprehensive toxicity assessment was included in just 20 studies (47%) and poorly reported in 6 studies (14%). Few studies included quality of life as a secondary endpoint. The authors noted that in the soft tissue sarcoma setting in which the purpose of systemic treatment may be palliation of symptoms, this is a concern.

Over the 4 decades represented by the systematic review, several trends appeared. Overall, a low proportion of studies included intent-to-treat analyses and clearly defined primary endpoints, but these characteristics improved over time. Endpoint selection has shifted away from response rate in favor of time-based events, including PFS, 3-month PFS, and 6-month PFS. Overall survival was the primary endpoint in just 4% of studies. Studies published in the last 2 decades were more likely to be supported by industry (5% vs. 35%).

Dr. Zer and coauthors reported having no relevant financial disclosures.

WASHINGTON – Children who have had a hematopoietic stem cell transplant (HSCT) have an increased risk of benign and atypical nevi, Dr. Johanna Sheu reported at the annual meeting of the American Academy of Dermatology.

These patients need to have routine skin exams and be educated about sun protection needs, she said. Based on her study, these needs are not routinely met.

At least 1 year after undergoing HSCT at Boston Children’s Hospital, 85 posttransplant patients had significantly more nevi and more atypical nevi than did 85 healthy controls who were matched by age, gender, and Fitzpatrick skin type. In addition, 41% of the transplant recipients had at least one actinic keratosis, a basal or squamous cell carcinoma, or a solar lentigo; 11% had at least one nevus spilus.

Moreover, “sun protection … and dermatology follow-up was poor” among the transplant recipients, said Dr. Sheu, of MassGeneral Hospital for Children, Boston. About 40% of the transplant recipients reported having a sunburn since their transplant, only 15% reported daily use of sunscreen, and 53% said they did not recall being told that sunburn could trigger graft-versus-host disease (GVHD).

About one-third of the patients had never seen a dermatologist; of those who had, two-thirds had only seen the dermatologist once, Dr. Sheu reported.

Late skin effects of HSCT are not as well described in children as they are in adults, she said. In adults, late skin effects include vitiligo, psoriasis, nonmelanoma skin cancers, and an increased nevi count.

The children in the study had undergone an HSCT between 1998 and 2013, at a median age of about 7 years (range was 1 month to 19 years). At the time of their skin exams, their mean age was 14 years, and they had been followed for a median of almost 4 years. Nevi were counted on the forearms, backs, legs, palms, and soles.

The median nevi count was 44 nevi, significantly more than the level seen in control subjects. Transplant recipients also had significantly more nevi in sun-exposed areas of the body, as well as on the palms and soles. Transplant recipients were more likely to have atypical nevi and to have nevi greater than 5 mm in diameter.

In addition to fair skin, factors associated with an increase in the overall nevi count included being older than age 10 at the time of the transplant and having total body irradiation, pretransplant chemotherapy, and myeloablative conditioning. Having had a sunburn since the transplant, reported by 40%, was also a risk factor.

Chronic GVHD and chronic GVHD of the skin were associated with the presence of atypical nevi; acute GVHD, the duration of immune suppression, and the use of topical steroids or calcineurin inhibitors were not associated with increased risk of atypical nevi.

She and her coinvestigators are currently analyzing the pathogenesis of these late effects in this population, and autoimmune skin conditions – vitiligo and alopecia – in 25% of the transplant recipients in the study.

In 2013, 1,100 children under aged 16 years in the United States underwent a bone marrow transplant, she noted.

Dr. Sheu had no disclosures.

[email protected]

WASHINGTON – Children who have had a hematopoietic stem cell transplant (HSCT) have an increased risk of benign and atypical nevi, Dr. Johanna Sheu reported at the annual meeting of the American Academy of Dermatology.

These patients need to have routine skin exams and be educated about sun protection needs, she said. Based on her study, these needs are not routinely met.

At least 1 year after undergoing HSCT at Boston Children’s Hospital, 85 posttransplant patients had significantly more nevi and more atypical nevi than did 85 healthy controls who were matched by age, gender, and Fitzpatrick skin type. In addition, 41% of the transplant recipients had at least one actinic keratosis, a basal or squamous cell carcinoma, or a solar lentigo; 11% had at least one nevus spilus.

Moreover, “sun protection … and dermatology follow-up was poor” among the transplant recipients, said Dr. Sheu, of MassGeneral Hospital for Children, Boston. About 40% of the transplant recipients reported having a sunburn since their transplant, only 15% reported daily use of sunscreen, and 53% said they did not recall being told that sunburn could trigger graft-versus-host disease (GVHD).

About one-third of the patients had never seen a dermatologist; of those who had, two-thirds had only seen the dermatologist once, Dr. Sheu reported.

Late skin effects of HSCT are not as well described in children as they are in adults, she said. In adults, late skin effects include vitiligo, psoriasis, nonmelanoma skin cancers, and an increased nevi count.

The children in the study had undergone an HSCT between 1998 and 2013, at a median age of about 7 years (range was 1 month to 19 years). At the time of their skin exams, their mean age was 14 years, and they had been followed for a median of almost 4 years. Nevi were counted on the forearms, backs, legs, palms, and soles.

The median nevi count was 44 nevi, significantly more than the level seen in control subjects. Transplant recipients also had significantly more nevi in sun-exposed areas of the body, as well as on the palms and soles. Transplant recipients were more likely to have atypical nevi and to have nevi greater than 5 mm in diameter.

In addition to fair skin, factors associated with an increase in the overall nevi count included being older than age 10 at the time of the transplant and having total body irradiation, pretransplant chemotherapy, and myeloablative conditioning. Having had a sunburn since the transplant, reported by 40%, was also a risk factor.

Chronic GVHD and chronic GVHD of the skin were associated with the presence of atypical nevi; acute GVHD, the duration of immune suppression, and the use of topical steroids or calcineurin inhibitors were not associated with increased risk of atypical nevi.

She and her coinvestigators are currently analyzing the pathogenesis of these late effects in this population, and autoimmune skin conditions – vitiligo and alopecia – in 25% of the transplant recipients in the study.

In 2013, 1,100 children under aged 16 years in the United States underwent a bone marrow transplant, she noted.

Dr. Sheu had no disclosures.

[email protected]

WASHINGTON – Children who have had a hematopoietic stem cell transplant (HSCT) have an increased risk of benign and atypical nevi, Dr. Johanna Sheu reported at the annual meeting of the American Academy of Dermatology.

These patients need to have routine skin exams and be educated about sun protection needs, she said. Based on her study, these needs are not routinely met.

At least 1 year after undergoing HSCT at Boston Children’s Hospital, 85 posttransplant patients had significantly more nevi and more atypical nevi than did 85 healthy controls who were matched by age, gender, and Fitzpatrick skin type. In addition, 41% of the transplant recipients had at least one actinic keratosis, a basal or squamous cell carcinoma, or a solar lentigo; 11% had at least one nevus spilus.

Moreover, “sun protection … and dermatology follow-up was poor” among the transplant recipients, said Dr. Sheu, of MassGeneral Hospital for Children, Boston. About 40% of the transplant recipients reported having a sunburn since their transplant, only 15% reported daily use of sunscreen, and 53% said they did not recall being told that sunburn could trigger graft-versus-host disease (GVHD).

About one-third of the patients had never seen a dermatologist; of those who had, two-thirds had only seen the dermatologist once, Dr. Sheu reported.

Late skin effects of HSCT are not as well described in children as they are in adults, she said. In adults, late skin effects include vitiligo, psoriasis, nonmelanoma skin cancers, and an increased nevi count.

The children in the study had undergone an HSCT between 1998 and 2013, at a median age of about 7 years (range was 1 month to 19 years). At the time of their skin exams, their mean age was 14 years, and they had been followed for a median of almost 4 years. Nevi were counted on the forearms, backs, legs, palms, and soles.

The median nevi count was 44 nevi, significantly more than the level seen in control subjects. Transplant recipients also had significantly more nevi in sun-exposed areas of the body, as well as on the palms and soles. Transplant recipients were more likely to have atypical nevi and to have nevi greater than 5 mm in diameter.

In addition to fair skin, factors associated with an increase in the overall nevi count included being older than age 10 at the time of the transplant and having total body irradiation, pretransplant chemotherapy, and myeloablative conditioning. Having had a sunburn since the transplant, reported by 40%, was also a risk factor.

Chronic GVHD and chronic GVHD of the skin were associated with the presence of atypical nevi; acute GVHD, the duration of immune suppression, and the use of topical steroids or calcineurin inhibitors were not associated with increased risk of atypical nevi.

She and her coinvestigators are currently analyzing the pathogenesis of these late effects in this population, and autoimmune skin conditions – vitiligo and alopecia – in 25% of the transplant recipients in the study.

In 2013, 1,100 children under aged 16 years in the United States underwent a bone marrow transplant, she noted.

Dr. Sheu had no disclosures.

[email protected]

NEW ORLEANS – Repeated intrathecal administration of autologous mesenchymal bone marrow-derived stromal stem cells for the treatment of multiple sclerosis was safe and induced accelerated beneficial effects in some patients in an uncontrolled, prospective study.

Of 28 patients with either secondary progressive or relapsing-progressive MS who were experiencing severe clinical deterioration and failure to respond to first- and second-line immunomodulatory treatments, 25 experienced either stable or improved Expanded Disability Status Scale (EDSS) scores following autologous mesenchymal stem cell (MSC) injections. The mean score decreased from 6.76 at study entry to 6.57 at a mean follow-up of 3.6 years, Dr. Panayiota Petrou of Hadassah-Hebrew University Medical Center, Jerusalem, Israel, and her colleagues reported in a poster at a meeting held by the Americas Committee for Treatment and Research in Multiple Sclerosis.

©Zerbor/thinkstockphotos.com

In addition, 17 patients experienced improvements in at least one functional system of the EDSS, including 14 who experienced improved motor function, 5 who experienced improved speech/bulbar functions, 4 who experienced improved urinary functions, and 6 who experienced improved cerebellar function. Eight patients remained stable during the entire follow-up period.

In a prior pilot trial, intrathecal administration of MSCs was shown to be safe and provided “some indications of potentially clinically meaningful beneficial effects on the progression of the disease,” the investigators said.

The current study provides further support for those findings. It included patients who experienced severe clinical deterioration (at least 0.5-1 points in the EDSS) during the year prior to study enrollment, or who had at least one major relapse without sufficient recovery following steroid treatment. Study subjects had a mean age of 56 years and mean disease duration of 15.4 years. They received at least 2 courses and up to 10 injections with 1 million cells/kg; most received 2 (8 patients) or 3 (9 patients) injections, and they were followed for up to 6 years.

No serious side effects were observed during long-term follow-up after repeated intrathecal injections. Eight patients experienced headaches and/or fever in the hours and days after injection, and two experienced symptoms of encephalopathy, which resolved within a few hours. Also, one patient experienced back pain and one had neck rigidity, but no long-term side effects were reported, the investigators said.

Immunological follow-up showed a transient up-regulation of regulatory T cells and down-regulation of the proliferative ability of lymphocytes and of several immune activation surface markers for up to 3 months, they noted.

The investigators reported having no disclosures.

[email protected]

NEW ORLEANS – Repeated intrathecal administration of autologous mesenchymal bone marrow-derived stromal stem cells for the treatment of multiple sclerosis was safe and induced accelerated beneficial effects in some patients in an uncontrolled, prospective study.

Of 28 patients with either secondary progressive or relapsing-progressive MS who were experiencing severe clinical deterioration and failure to respond to first- and second-line immunomodulatory treatments, 25 experienced either stable or improved Expanded Disability Status Scale (EDSS) scores following autologous mesenchymal stem cell (MSC) injections. The mean score decreased from 6.76 at study entry to 6.57 at a mean follow-up of 3.6 years, Dr. Panayiota Petrou of Hadassah-Hebrew University Medical Center, Jerusalem, Israel, and her colleagues reported in a poster at a meeting held by the Americas Committee for Treatment and Research in Multiple Sclerosis.

©Zerbor/thinkstockphotos.com

In addition, 17 patients experienced improvements in at least one functional system of the EDSS, including 14 who experienced improved motor function, 5 who experienced improved speech/bulbar functions, 4 who experienced improved urinary functions, and 6 who experienced improved cerebellar function. Eight patients remained stable during the entire follow-up period.

In a prior pilot trial, intrathecal administration of MSCs was shown to be safe and provided “some indications of potentially clinically meaningful beneficial effects on the progression of the disease,” the investigators said.

The current study provides further support for those findings. It included patients who experienced severe clinical deterioration (at least 0.5-1 points in the EDSS) during the year prior to study enrollment, or who had at least one major relapse without sufficient recovery following steroid treatment. Study subjects had a mean age of 56 years and mean disease duration of 15.4 years. They received at least 2 courses and up to 10 injections with 1 million cells/kg; most received 2 (8 patients) or 3 (9 patients) injections, and they were followed for up to 6 years.

No serious side effects were observed during long-term follow-up after repeated intrathecal injections. Eight patients experienced headaches and/or fever in the hours and days after injection, and two experienced symptoms of encephalopathy, which resolved within a few hours. Also, one patient experienced back pain and one had neck rigidity, but no long-term side effects were reported, the investigators said.

Immunological follow-up showed a transient up-regulation of regulatory T cells and down-regulation of the proliferative ability of lymphocytes and of several immune activation surface markers for up to 3 months, they noted.

The investigators reported having no disclosures.

[email protected]

NEW ORLEANS – Repeated intrathecal administration of autologous mesenchymal bone marrow-derived stromal stem cells for the treatment of multiple sclerosis was safe and induced accelerated beneficial effects in some patients in an uncontrolled, prospective study.

Of 28 patients with either secondary progressive or relapsing-progressive MS who were experiencing severe clinical deterioration and failure to respond to first- and second-line immunomodulatory treatments, 25 experienced either stable or improved Expanded Disability Status Scale (EDSS) scores following autologous mesenchymal stem cell (MSC) injections. The mean score decreased from 6.76 at study entry to 6.57 at a mean follow-up of 3.6 years, Dr. Panayiota Petrou of Hadassah-Hebrew University Medical Center, Jerusalem, Israel, and her colleagues reported in a poster at a meeting held by the Americas Committee for Treatment and Research in Multiple Sclerosis.

©Zerbor/thinkstockphotos.com

In addition, 17 patients experienced improvements in at least one functional system of the EDSS, including 14 who experienced improved motor function, 5 who experienced improved speech/bulbar functions, 4 who experienced improved urinary functions, and 6 who experienced improved cerebellar function. Eight patients remained stable during the entire follow-up period.

In a prior pilot trial, intrathecal administration of MSCs was shown to be safe and provided “some indications of potentially clinically meaningful beneficial effects on the progression of the disease,” the investigators said.

The current study provides further support for those findings. It included patients who experienced severe clinical deterioration (at least 0.5-1 points in the EDSS) during the year prior to study enrollment, or who had at least one major relapse without sufficient recovery following steroid treatment. Study subjects had a mean age of 56 years and mean disease duration of 15.4 years. They received at least 2 courses and up to 10 injections with 1 million cells/kg; most received 2 (8 patients) or 3 (9 patients) injections, and they were followed for up to 6 years.

No serious side effects were observed during long-term follow-up after repeated intrathecal injections. Eight patients experienced headaches and/or fever in the hours and days after injection, and two experienced symptoms of encephalopathy, which resolved within a few hours. Also, one patient experienced back pain and one had neck rigidity, but no long-term side effects were reported, the investigators said.

Immunological follow-up showed a transient up-regulation of regulatory T cells and down-regulation of the proliferative ability of lymphocytes and of several immune activation surface markers for up to 3 months, they noted.

The investigators reported having no disclosures.

[email protected]

LOS ANGELES – A peanut allergy prevention strategy based upon regular consumption of peanut-containing foods from infancy to age 5 continued to provide protection even after peanut intake was halted for a full year from age 5 to 6, according to new results from an extension of the landmark LEAP trial, known as LEAP-On, presented at the annual meeting of the American Academy of Allergy, Asthma, and Immunology.

The impetus for LEAP-On was the investigators’ concern that a period of peanut avoidance might cause loss of the protective state. But that didn’t occur.

“I think there is no doubt that we have prevented peanut allergy so far in these high-risk children. Next, the LEAP-Ad Lib study will tell us whether we’ve prevented it by age 10,” said Dr. Gideon Lack of King’s College London, who headed LEAP-On.

Bruce Jancin/Frontline Medical News

A second major randomized trial known as EAT (Enquiring About Tolerance) presented at the meeting provided further support for early dietary introduction of allergenic foods. EAT differed from LEAP (Learning Early About Peanut Allergy) and LEAP-On in that it ambitiously randomized infants to early introduction or avoidance of not one but six allergenic foods: peanut, cooked egg, cow’s milk, fish, sesame, and wheat. Also, while LEAP and LEAP-On involved roughly 600 infants known to be at very high risk for allergy, EAT was conducted in a general population of 1,303 infants who weren’t at increased risk, all of whom were exclusively breast-fed until the intervention beginning at age 3 months.

The presentation of the LEAP-On and EAT results at the AAAAI annual meeting was a major event marked by the National Institute of Allergy and Infectious Diseases by same-day release of new NIAID-sponsored draft recommendations for the diagnosis and management of food allergies.

In a press conference held at the AAAAI annual meeting to announce the start of a 45-day public comment period for the draft update of the 2010 guidelines, Dr. Daniel Rotrosen, director of NIAID’s division of allergy, immunology and transplantation, said the new guidelines were developed largely in response to the compelling LEAP findings. That trial demonstrated that sustained consumption of peanut starting in infancy resulted in an 81% lower rate of peanut allergy at age 5 years compared to a strategy of peanut avoidance (N Engl J Med. 2015;372:803-13).

Bruce Jancin/Frontline Medical News

The draft guidelines, now available on the NIAID website, represent a sharp departure from the former recommendation that physicians encourage exclusive breastfeeding for the first 6 months of life followed by cautious introduction of other foods. Whereas the former orthodoxy was that delayed introduction of allergenic foods protects against development of food allergy, the new evidence-based concept supported by the LEAP and EAT findings is that just the opposite is true: that is, introduction of such foods during the period of immunologic plasticity in infancy induces tolerance.

Thus, the draft guidelines recommend that infants at high risk for peanut allergy because they have severe eczema and/or egg allergy should have introduction of peanut-containing food at 4-6 months of age to reduce their risk of peanut allergy, preceded by evaluation using peanut-specific IgE or skin prick testing to make sure it’s safe. That age window coincides with well-child visits and vaccination schedules, Dr. Rotrosen noted.

These guidelines represent the consensus of 26 organizations that participated in their development. Among them are the American Academy of Pediatrics, the American Academy of Family Physicians, the American Academy of Dermatology, the American College of Gastroenterology, and AAAAI.

“I expect the new guidelines, when finalized, to be endorsed by the leadership of all the participating organizations,” Dr. Rotrosen said.

The new paradigm will require cultural change, said Dr. James R. Baker Jr., CEO and chief medical officer of Food Allergy Research and Education, a nonprofit organization that provided partial funding for LEAP and LEAP-On.

Bruce Jancin/Frontline Medical News

“I think for a long time we’ve vilified these foods. There’s nothing inherently wrong with their intake, and that’s a message we need to get across to parents and physicians so they can start thinking differently,” he said.

“The good news about these studies is that they show there’s no reason not to do this,” Dr. Baker added. “There’s no harm that comes from the early introduction.”

Dr. Lack, who led the EAT trial, noted that the study didn’t meet it’s primary endpoint of a significantly lower prevalence of food allergy to any of the six intervention foods at age 3 years in the intention-to-treat analysis. But adherence to the demanding EAT early-introduction protocol was a problem. Indeed, only 43% of participants adhered to the study protocol. In a per-protocol analysis restricted to the adherent group, however, early introduction was associated with a highly significant 67% reduction in the relative risk of food allergy at 3 years of age compared to controls. And for the two most prevalent food allergies – to peanut and egg – the relative risk reductions in the early-introduction group were 100% and 75%, respectively.

The EAT results suggest that an effective preventive dose of peanut in infants at least 3 months of age is roughly 2 g of peanut protein per week, equivalent to just under 2 tsp of peanut butter, according to Dr. Lack.

Simultaneously with presentation of the LEAP-On and EAT trials in Los Angeles, the studies were published online at NEJM.org (doi: 10.1056/NEJMoa1514210 for LEAP-ON and 10.1056/NEJMoa1514209 for EAT).

LEAP-On was supported primarily by NIAID. EAT was funded mainly by the UK Foods Standards Agency and the Medical Research Council. Dr. Lack reported receiving grants from those agencies as well as Food Allergy Research and Education.

LOS ANGELES – A peanut allergy prevention strategy based upon regular consumption of peanut-containing foods from infancy to age 5 continued to provide protection even after peanut intake was halted for a full year from age 5 to 6, according to new results from an extension of the landmark LEAP trial, known as LEAP-On, presented at the annual meeting of the American Academy of Allergy, Asthma, and Immunology.

The impetus for LEAP-On was the investigators’ concern that a period of peanut avoidance might cause loss of the protective state. But that didn’t occur.

“I think there is no doubt that we have prevented peanut allergy so far in these high-risk children. Next, the LEAP-Ad Lib study will tell us whether we’ve prevented it by age 10,” said Dr. Gideon Lack of King’s College London, who headed LEAP-On.

Bruce Jancin/Frontline Medical News

A second major randomized trial known as EAT (Enquiring About Tolerance) presented at the meeting provided further support for early dietary introduction of allergenic foods. EAT differed from LEAP (Learning Early About Peanut Allergy) and LEAP-On in that it ambitiously randomized infants to early introduction or avoidance of not one but six allergenic foods: peanut, cooked egg, cow’s milk, fish, sesame, and wheat. Also, while LEAP and LEAP-On involved roughly 600 infants known to be at very high risk for allergy, EAT was conducted in a general population of 1,303 infants who weren’t at increased risk, all of whom were exclusively breast-fed until the intervention beginning at age 3 months.

The presentation of the LEAP-On and EAT results at the AAAAI annual meeting was a major event marked by the National Institute of Allergy and Infectious Diseases by same-day release of new NIAID-sponsored draft recommendations for the diagnosis and management of food allergies.

In a press conference held at the AAAAI annual meeting to announce the start of a 45-day public comment period for the draft update of the 2010 guidelines, Dr. Daniel Rotrosen, director of NIAID’s division of allergy, immunology and transplantation, said the new guidelines were developed largely in response to the compelling LEAP findings. That trial demonstrated that sustained consumption of peanut starting in infancy resulted in an 81% lower rate of peanut allergy at age 5 years compared to a strategy of peanut avoidance (N Engl J Med. 2015;372:803-13).

Bruce Jancin/Frontline Medical News

The draft guidelines, now available on the NIAID website, represent a sharp departure from the former recommendation that physicians encourage exclusive breastfeeding for the first 6 months of life followed by cautious introduction of other foods. Whereas the former orthodoxy was that delayed introduction of allergenic foods protects against development of food allergy, the new evidence-based concept supported by the LEAP and EAT findings is that just the opposite is true: that is, introduction of such foods during the period of immunologic plasticity in infancy induces tolerance.

Thus, the draft guidelines recommend that infants at high risk for peanut allergy because they have severe eczema and/or egg allergy should have introduction of peanut-containing food at 4-6 months of age to reduce their risk of peanut allergy, preceded by evaluation using peanut-specific IgE or skin prick testing to make sure it’s safe. That age window coincides with well-child visits and vaccination schedules, Dr. Rotrosen noted.

These guidelines represent the consensus of 26 organizations that participated in their development. Among them are the American Academy of Pediatrics, the American Academy of Family Physicians, the American Academy of Dermatology, the American College of Gastroenterology, and AAAAI.

“I expect the new guidelines, when finalized, to be endorsed by the leadership of all the participating organizations,” Dr. Rotrosen said.

The new paradigm will require cultural change, said Dr. James R. Baker Jr., CEO and chief medical officer of Food Allergy Research and Education, a nonprofit organization that provided partial funding for LEAP and LEAP-On.

Bruce Jancin/Frontline Medical News

“I think for a long time we’ve vilified these foods. There’s nothing inherently wrong with their intake, and that’s a message we need to get across to parents and physicians so they can start thinking differently,” he said.

“The good news about these studies is that they show there’s no reason not to do this,” Dr. Baker added. “There’s no harm that comes from the early introduction.”

Dr. Lack, who led the EAT trial, noted that the study didn’t meet it’s primary endpoint of a significantly lower prevalence of food allergy to any of the six intervention foods at age 3 years in the intention-to-treat analysis. But adherence to the demanding EAT early-introduction protocol was a problem. Indeed, only 43% of participants adhered to the study protocol. In a per-protocol analysis restricted to the adherent group, however, early introduction was associated with a highly significant 67% reduction in the relative risk of food allergy at 3 years of age compared to controls. And for the two most prevalent food allergies – to peanut and egg – the relative risk reductions in the early-introduction group were 100% and 75%, respectively.

The EAT results suggest that an effective preventive dose of peanut in infants at least 3 months of age is roughly 2 g of peanut protein per week, equivalent to just under 2 tsp of peanut butter, according to Dr. Lack.

Simultaneously with presentation of the LEAP-On and EAT trials in Los Angeles, the studies were published online at NEJM.org (doi: 10.1056/NEJMoa1514210 for LEAP-ON and 10.1056/NEJMoa1514209 for EAT).

LEAP-On was supported primarily by NIAID. EAT was funded mainly by the UK Foods Standards Agency and the Medical Research Council. Dr. Lack reported receiving grants from those agencies as well as Food Allergy Research and Education.

LOS ANGELES – A peanut allergy prevention strategy based upon regular consumption of peanut-containing foods from infancy to age 5 continued to provide protection even after peanut intake was halted for a full year from age 5 to 6, according to new results from an extension of the landmark LEAP trial, known as LEAP-On, presented at the annual meeting of the American Academy of Allergy, Asthma, and Immunology.

The impetus for LEAP-On was the investigators’ concern that a period of peanut avoidance might cause loss of the protective state. But that didn’t occur.

“I think there is no doubt that we have prevented peanut allergy so far in these high-risk children. Next, the LEAP-Ad Lib study will tell us whether we’ve prevented it by age 10,” said Dr. Gideon Lack of King’s College London, who headed LEAP-On.

Bruce Jancin/Frontline Medical News

A second major randomized trial known as EAT (Enquiring About Tolerance) presented at the meeting provided further support for early dietary introduction of allergenic foods. EAT differed from LEAP (Learning Early About Peanut Allergy) and LEAP-On in that it ambitiously randomized infants to early introduction or avoidance of not one but six allergenic foods: peanut, cooked egg, cow’s milk, fish, sesame, and wheat. Also, while LEAP and LEAP-On involved roughly 600 infants known to be at very high risk for allergy, EAT was conducted in a general population of 1,303 infants who weren’t at increased risk, all of whom were exclusively breast-fed until the intervention beginning at age 3 months.

The presentation of the LEAP-On and EAT results at the AAAAI annual meeting was a major event marked by the National Institute of Allergy and Infectious Diseases by same-day release of new NIAID-sponsored draft recommendations for the diagnosis and management of food allergies.

In a press conference held at the AAAAI annual meeting to announce the start of a 45-day public comment period for the draft update of the 2010 guidelines, Dr. Daniel Rotrosen, director of NIAID’s division of allergy, immunology and transplantation, said the new guidelines were developed largely in response to the compelling LEAP findings. That trial demonstrated that sustained consumption of peanut starting in infancy resulted in an 81% lower rate of peanut allergy at age 5 years compared to a strategy of peanut avoidance (N Engl J Med. 2015;372:803-13).

Bruce Jancin/Frontline Medical News

The draft guidelines, now available on the NIAID website, represent a sharp departure from the former recommendation that physicians encourage exclusive breastfeeding for the first 6 months of life followed by cautious introduction of other foods. Whereas the former orthodoxy was that delayed introduction of allergenic foods protects against development of food allergy, the new evidence-based concept supported by the LEAP and EAT findings is that just the opposite is true: that is, introduction of such foods during the period of immunologic plasticity in infancy induces tolerance.

Thus, the draft guidelines recommend that infants at high risk for peanut allergy because they have severe eczema and/or egg allergy should have introduction of peanut-containing food at 4-6 months of age to reduce their risk of peanut allergy, preceded by evaluation using peanut-specific IgE or skin prick testing to make sure it’s safe. That age window coincides with well-child visits and vaccination schedules, Dr. Rotrosen noted.

These guidelines represent the consensus of 26 organizations that participated in their development. Among them are the American Academy of Pediatrics, the American Academy of Family Physicians, the American Academy of Dermatology, the American College of Gastroenterology, and AAAAI.

“I expect the new guidelines, when finalized, to be endorsed by the leadership of all the participating organizations,” Dr. Rotrosen said.

The new paradigm will require cultural change, said Dr. James R. Baker Jr., CEO and chief medical officer of Food Allergy Research and Education, a nonprofit organization that provided partial funding for LEAP and LEAP-On.

Bruce Jancin/Frontline Medical News

“I think for a long time we’ve vilified these foods. There’s nothing inherently wrong with their intake, and that’s a message we need to get across to parents and physicians so they can start thinking differently,” he said.

“The good news about these studies is that they show there’s no reason not to do this,” Dr. Baker added. “There’s no harm that comes from the early introduction.”

Dr. Lack, who led the EAT trial, noted that the study didn’t meet it’s primary endpoint of a significantly lower prevalence of food allergy to any of the six intervention foods at age 3 years in the intention-to-treat analysis. But adherence to the demanding EAT early-introduction protocol was a problem. Indeed, only 43% of participants adhered to the study protocol. In a per-protocol analysis restricted to the adherent group, however, early introduction was associated with a highly significant 67% reduction in the relative risk of food allergy at 3 years of age compared to controls. And for the two most prevalent food allergies – to peanut and egg – the relative risk reductions in the early-introduction group were 100% and 75%, respectively.

The EAT results suggest that an effective preventive dose of peanut in infants at least 3 months of age is roughly 2 g of peanut protein per week, equivalent to just under 2 tsp of peanut butter, according to Dr. Lack.

Simultaneously with presentation of the LEAP-On and EAT trials in Los Angeles, the studies were published online at NEJM.org (doi: 10.1056/NEJMoa1514210 for LEAP-ON and 10.1056/NEJMoa1514209 for EAT).

LEAP-On was supported primarily by NIAID. EAT was funded mainly by the UK Foods Standards Agency and the Medical Research Council. Dr. Lack reported receiving grants from those agencies as well as Food Allergy Research and Education.