ATLANTA – While there is no question about the need to address pockets of increasing vaccine refusals, determining how to address it requires a better understanding of the forces underlying vaccine hesitancy.

This area of research is still young, but Glen Nowak, PhD, a visiting communication scientist at the National Vaccine Program Office and director of the Grady College Center for Health & Risk Communication at the University of Georgia in Athens, drew on multiple recent studies and an in-progress review of vaccine hesitancy and confidence literature to distill five key findings from recent research into vaccine hesitancy. He presented that summary at a conference sponsored by the Centers for Disease Control and Prevention.
 

The first insight: There is a lot of interest in understanding vaccine hesitancy and confidence. But the rub is that many inconsistencies and uncertainties exist, because efforts remain in the early stages of research.

Dr. Nowak referenced the November 2014 report of the World Health Organization’s Strategic Advisory Group of Experts (SAGE) on Immunization to define vaccine hesitancy as the “delay in acceptance or refusal of vaccines despite availability of vaccine services.” But that hesitancy is complex and context specific, varying across time, place, and type of vaccine, the report found.

Those who are hesitant about vaccines are not a homogeneous group, Dr. Nowak said. Their degree of indecision ranges from refusing all vaccines, refusing some and accepting others, or delaying some but not others, to full acceptance of all vaccines despite hesitancy. Their attitudes also vary about vaccination overall and about specific vaccines.

“Vaccines hesitancy is influenced by several factors: complacency, convenience, and confidence,” Dr. Nowak said.

“Generally speaking, the end goal of all of our efforts is vaccine coverage, and before that is vaccine acceptance,” he said. “Before acceptance is hesitancy, and confidence is considered the precursor to hesitancy.” But no clear definition or measure of “vaccine confidence” exists yet.

Dr. Nowak next highlighted the second key finding: that research has identified an association between vaccine hesitancy or vaccine-related hesitancy and vaccine acceptance.

A 2016 study found that scores from the Attitudes about Childhood Vaccines Survey predicted under-immunization in children at 19 months of age, and three studies from 2008 through 2012 found a greater likelihood to delay or refuse vaccines among parents who had vaccine-related doubts.

Focus groups have found that parents who express hesitation or a lack of trust in vaccines also tend to mention using “alternative schedules,” including delaying vaccines or only vaccinating their children with select vaccines instead of all the recommended immunizations.

The third key finding Dr. Nowak discussed returned to the idea of “vaccine confidence,” which has aroused more interest in research but which requires refinement before it can become a truly helpful concept. Studies have already found links between confidence and parents vaccinating their children, but the field lacks standard measures.

“There are all different definitions that are out there, but they have not been measured,” Dr. Nowak said.

For example, the 2015 National Vaccine Advisory Committee report defined vaccine confidence as parents’ or health care providers’ trust in three areas: the immunizations recommended by the CDC’s Advisory Committee on Immunization Practices, the providers who administer the vaccines, and the processes that lead to vaccine licensure and vaccine recommendations.

But other definitions might include having faith that a person will benefit from a vaccine or that they won’t experience harm, or lacking any concerns about potential adverse outcomes.

The fourth key finding of recent research delivered positive news, Dr. Nowak noted: “Vaccines do relatively well compared to other health-related products that parents of young children have to make decisions about, such as antibiotics, over-the-counter medicines and vitamins.”

For example, in one study, the mean score (scale 1-10) of parents’ confidence that their child will not have a bad or serious adverse reaction to a recommended vaccine was 6.6, the same as the confidence level for antibiotics and only slightly below the scores of 6.8 for OTC medications and 7.3 for vitamins. Vaccines and antibiotics tied for the highest score for parents’ confidence in their effectiveness: 7.1, compared with 6.3 for OTC medications and 5.8 for vitamins. And of all four products, parents had the highest faith in vaccines as benefiting their children’s health.

But it was the final finding Dr. Nowak discussed that can present some of the greatest challenges to addressing vaccine hesitancy: Parents’ direct and indirect experiences play a significant role in their confidence about vaccines.

One study found that nearly a quarter of parents reported knowing someone who had a “bad reaction” to a vaccine (aside from soreness, fever, redness, or swelling), compared with 16.7% reporting that someone they knew had a bad reaction to an OTC medication. About one-third of parents reported the same for antibiotics.

Similarly, the measles outbreak at Disneyland in 2015 increased parents’ confidence in the safety and effectiveness of the CDC-recommended childhood vaccination schedule, and in the belief that their child’s health would benefit from receiving all the recommended vaccines.

Dr. Nowak reported no disclosures.

[email protected]

ATLANTA – While there is no question about the need to address pockets of increasing vaccine refusals, determining how to address it requires a better understanding of the forces underlying vaccine hesitancy.

This area of research is still young, but Glen Nowak, PhD, a visiting communication scientist at the National Vaccine Program Office and director of the Grady College Center for Health & Risk Communication at the University of Georgia in Athens, drew on multiple recent studies and an in-progress review of vaccine hesitancy and confidence literature to distill five key findings from recent research into vaccine hesitancy. He presented that summary at a conference sponsored by the Centers for Disease Control and Prevention.
 

The first insight: There is a lot of interest in understanding vaccine hesitancy and confidence. But the rub is that many inconsistencies and uncertainties exist, because efforts remain in the early stages of research.

Dr. Nowak referenced the November 2014 report of the World Health Organization’s Strategic Advisory Group of Experts (SAGE) on Immunization to define vaccine hesitancy as the “delay in acceptance or refusal of vaccines despite availability of vaccine services.” But that hesitancy is complex and context specific, varying across time, place, and type of vaccine, the report found.

Those who are hesitant about vaccines are not a homogeneous group, Dr. Nowak said. Their degree of indecision ranges from refusing all vaccines, refusing some and accepting others, or delaying some but not others, to full acceptance of all vaccines despite hesitancy. Their attitudes also vary about vaccination overall and about specific vaccines.

“Vaccines hesitancy is influenced by several factors: complacency, convenience, and confidence,” Dr. Nowak said.

“Generally speaking, the end goal of all of our efforts is vaccine coverage, and before that is vaccine acceptance,” he said. “Before acceptance is hesitancy, and confidence is considered the precursor to hesitancy.” But no clear definition or measure of “vaccine confidence” exists yet.

Dr. Nowak next highlighted the second key finding: that research has identified an association between vaccine hesitancy or vaccine-related hesitancy and vaccine acceptance.

A 2016 study found that scores from the Attitudes about Childhood Vaccines Survey predicted under-immunization in children at 19 months of age, and three studies from 2008 through 2012 found a greater likelihood to delay or refuse vaccines among parents who had vaccine-related doubts.

Focus groups have found that parents who express hesitation or a lack of trust in vaccines also tend to mention using “alternative schedules,” including delaying vaccines or only vaccinating their children with select vaccines instead of all the recommended immunizations.

The third key finding Dr. Nowak discussed returned to the idea of “vaccine confidence,” which has aroused more interest in research but which requires refinement before it can become a truly helpful concept. Studies have already found links between confidence and parents vaccinating their children, but the field lacks standard measures.

“There are all different definitions that are out there, but they have not been measured,” Dr. Nowak said.

For example, the 2015 National Vaccine Advisory Committee report defined vaccine confidence as parents’ or health care providers’ trust in three areas: the immunizations recommended by the CDC’s Advisory Committee on Immunization Practices, the providers who administer the vaccines, and the processes that lead to vaccine licensure and vaccine recommendations.

But other definitions might include having faith that a person will benefit from a vaccine or that they won’t experience harm, or lacking any concerns about potential adverse outcomes.

The fourth key finding of recent research delivered positive news, Dr. Nowak noted: “Vaccines do relatively well compared to other health-related products that parents of young children have to make decisions about, such as antibiotics, over-the-counter medicines and vitamins.”

For example, in one study, the mean score (scale 1-10) of parents’ confidence that their child will not have a bad or serious adverse reaction to a recommended vaccine was 6.6, the same as the confidence level for antibiotics and only slightly below the scores of 6.8 for OTC medications and 7.3 for vitamins. Vaccines and antibiotics tied for the highest score for parents’ confidence in their effectiveness: 7.1, compared with 6.3 for OTC medications and 5.8 for vitamins. And of all four products, parents had the highest faith in vaccines as benefiting their children’s health.

But it was the final finding Dr. Nowak discussed that can present some of the greatest challenges to addressing vaccine hesitancy: Parents’ direct and indirect experiences play a significant role in their confidence about vaccines.

One study found that nearly a quarter of parents reported knowing someone who had a “bad reaction” to a vaccine (aside from soreness, fever, redness, or swelling), compared with 16.7% reporting that someone they knew had a bad reaction to an OTC medication. About one-third of parents reported the same for antibiotics.

Similarly, the measles outbreak at Disneyland in 2015 increased parents’ confidence in the safety and effectiveness of the CDC-recommended childhood vaccination schedule, and in the belief that their child’s health would benefit from receiving all the recommended vaccines.

Dr. Nowak reported no disclosures.

[email protected]

ATLANTA – While there is no question about the need to address pockets of increasing vaccine refusals, determining how to address it requires a better understanding of the forces underlying vaccine hesitancy.

This area of research is still young, but Glen Nowak, PhD, a visiting communication scientist at the National Vaccine Program Office and director of the Grady College Center for Health & Risk Communication at the University of Georgia in Athens, drew on multiple recent studies and an in-progress review of vaccine hesitancy and confidence literature to distill five key findings from recent research into vaccine hesitancy. He presented that summary at a conference sponsored by the Centers for Disease Control and Prevention.
 

The first insight: There is a lot of interest in understanding vaccine hesitancy and confidence. But the rub is that many inconsistencies and uncertainties exist, because efforts remain in the early stages of research.

Dr. Nowak referenced the November 2014 report of the World Health Organization’s Strategic Advisory Group of Experts (SAGE) on Immunization to define vaccine hesitancy as the “delay in acceptance or refusal of vaccines despite availability of vaccine services.” But that hesitancy is complex and context specific, varying across time, place, and type of vaccine, the report found.

Those who are hesitant about vaccines are not a homogeneous group, Dr. Nowak said. Their degree of indecision ranges from refusing all vaccines, refusing some and accepting others, or delaying some but not others, to full acceptance of all vaccines despite hesitancy. Their attitudes also vary about vaccination overall and about specific vaccines.

“Vaccines hesitancy is influenced by several factors: complacency, convenience, and confidence,” Dr. Nowak said.

“Generally speaking, the end goal of all of our efforts is vaccine coverage, and before that is vaccine acceptance,” he said. “Before acceptance is hesitancy, and confidence is considered the precursor to hesitancy.” But no clear definition or measure of “vaccine confidence” exists yet.

Dr. Nowak next highlighted the second key finding: that research has identified an association between vaccine hesitancy or vaccine-related hesitancy and vaccine acceptance.

A 2016 study found that scores from the Attitudes about Childhood Vaccines Survey predicted under-immunization in children at 19 months of age, and three studies from 2008 through 2012 found a greater likelihood to delay or refuse vaccines among parents who had vaccine-related doubts.

Focus groups have found that parents who express hesitation or a lack of trust in vaccines also tend to mention using “alternative schedules,” including delaying vaccines or only vaccinating their children with select vaccines instead of all the recommended immunizations.

The third key finding Dr. Nowak discussed returned to the idea of “vaccine confidence,” which has aroused more interest in research but which requires refinement before it can become a truly helpful concept. Studies have already found links between confidence and parents vaccinating their children, but the field lacks standard measures.

“There are all different definitions that are out there, but they have not been measured,” Dr. Nowak said.

For example, the 2015 National Vaccine Advisory Committee report defined vaccine confidence as parents’ or health care providers’ trust in three areas: the immunizations recommended by the CDC’s Advisory Committee on Immunization Practices, the providers who administer the vaccines, and the processes that lead to vaccine licensure and vaccine recommendations.

But other definitions might include having faith that a person will benefit from a vaccine or that they won’t experience harm, or lacking any concerns about potential adverse outcomes.

The fourth key finding of recent research delivered positive news, Dr. Nowak noted: “Vaccines do relatively well compared to other health-related products that parents of young children have to make decisions about, such as antibiotics, over-the-counter medicines and vitamins.”

For example, in one study, the mean score (scale 1-10) of parents’ confidence that their child will not have a bad or serious adverse reaction to a recommended vaccine was 6.6, the same as the confidence level for antibiotics and only slightly below the scores of 6.8 for OTC medications and 7.3 for vitamins. Vaccines and antibiotics tied for the highest score for parents’ confidence in their effectiveness: 7.1, compared with 6.3 for OTC medications and 5.8 for vitamins. And of all four products, parents had the highest faith in vaccines as benefiting their children’s health.

But it was the final finding Dr. Nowak discussed that can present some of the greatest challenges to addressing vaccine hesitancy: Parents’ direct and indirect experiences play a significant role in their confidence about vaccines.

One study found that nearly a quarter of parents reported knowing someone who had a “bad reaction” to a vaccine (aside from soreness, fever, redness, or swelling), compared with 16.7% reporting that someone they knew had a bad reaction to an OTC medication. About one-third of parents reported the same for antibiotics.

Similarly, the measles outbreak at Disneyland in 2015 increased parents’ confidence in the safety and effectiveness of the CDC-recommended childhood vaccination schedule, and in the belief that their child’s health would benefit from receiving all the recommended vaccines.

Dr. Nowak reported no disclosures.

[email protected]

SHM recently partnered with the Human Diagnosis Project, also referred to as Human Dx, for Global Morning Report. Human Dx is the world’s first open diagnostic system, which aims to understand the fundamental data structure of diagnosis and considerably impact the future cost of, access to, and effectiveness of healthcare globally.

The Hospitalist spoke with Shantanu Nundy, MD, MBA, a primary-care physician for the Human Diagnosis Project, to learn more about its inception and SHM’s partnership.

Question: How did the Global Morning Report project start?

Answer: We were at the University of California, San Francisco (UCSF), working on a morning report with master diagnostician Gurpreet Dhaliwal, MD, when we had an “aha moment” of sorts. Instead of the typical morning report, which uses a whiteboard or slide deck, residents and Dr. Dhaliwal worked through the case using the Human Dx open case collaboration software. At the end of the morning report, the case was tweeted out on social media for anyone in the world to solve, and within minutes, a medical student in Bangladesh not only was able to access the case but also access insights from the UCSF residents and Dr. Dhaliwal. That’s when we realized we were onto something big.

Q: What are the goals of Human Dx and Global Morning Report?

A: Repeated, rapid cycles of practice, feedback, and reinforcement are key components of learning. Sports training is a useful analogy—the best athletes practice drills daily, often for hours a day, and monitor their performance rigorously—but the same can be said for many other professions, including musicians, chefs, and public speakers.

In medicine, we call seeing patients every day “practice.” But we aren’t practicing if we aren’t getting feedback and improving—we are just performing. None of us can hope to be the Michael Phelps, Yo-Yo Ma, or Grant Achatz of medicine that our patients deserve us to be without real practice.

Human Dx builds on the science of learning by enabling physicians and students to quickly test and get feedback on their clinical reasoning skills. This is done both by receiving input on their own cases as well as giving input on other contributors’ cases to compare their thinking with physicians and students from around the world. Our goal is for Global Morning Report to become the daily personalized workout schedule for doctors everywhere. What I’d like to see is that rigorous practice and pursuit of excellence in clinical reasoning, diagnosis, and management becoming a core part of the physician experience.

Q: What kind of feedback are you hearing from participants?

A: Doctors love it! Many tell us this is their daily Sudoku or crossword that they do every morning to wake their minds up on the way to work. And our numbers show it: The average active participant contributes five cases per week. And today, that’s without any CME credit or other clear reward other than learning and enjoyment.

That said, we have much to improve, and we aren’t resting on our laurels. The whole ethos of the Human Diagnosis Project is created and led by the global medical community. We are lucky to have an incredible community of physicians and trainees globally who keep us moving forward each day.

Q: Why was a partnership with SHM appealing for this project?

A: At Human Dx, we look at ourselves simply as enablers. We are making it possible for the global medical community to come together and build something important for current and future generations. As such, we want to work with the best institutions in medicine to take their expertise, content, and community and make them more available to the world. As one of the largest, fastest growing, and innovative communities in medicine, SHM is an ideal partner, and we count ourselves very fortunate to have your support.

Q: How can hospitalists participate?

A: Start contributing cases! Not every doctor is interested in medical education, technology, or policy, but every physician I know has great cases and insights to share with the world. My hope is that for physicians and medical students, contributing to Human Dx is their 10 minutes a day to be a part of something greater than themselves, allowing them to share their insights with humankind, build a resource for current and future generations, and, in doing so, renew the reasons that brought them to medicine in the first place and find joy in clinical practice. TH

Join the movement today and solve a case now at www.humandx.org/shm.

SHM recently partnered with the Human Diagnosis Project, also referred to as Human Dx, for Global Morning Report. Human Dx is the world’s first open diagnostic system, which aims to understand the fundamental data structure of diagnosis and considerably impact the future cost of, access to, and effectiveness of healthcare globally.

The Hospitalist spoke with Shantanu Nundy, MD, MBA, a primary-care physician for the Human Diagnosis Project, to learn more about its inception and SHM’s partnership.

Question: How did the Global Morning Report project start?

Answer: We were at the University of California, San Francisco (UCSF), working on a morning report with master diagnostician Gurpreet Dhaliwal, MD, when we had an “aha moment” of sorts. Instead of the typical morning report, which uses a whiteboard or slide deck, residents and Dr. Dhaliwal worked through the case using the Human Dx open case collaboration software. At the end of the morning report, the case was tweeted out on social media for anyone in the world to solve, and within minutes, a medical student in Bangladesh not only was able to access the case but also access insights from the UCSF residents and Dr. Dhaliwal. That’s when we realized we were onto something big.

Q: What are the goals of Human Dx and Global Morning Report?

A: Repeated, rapid cycles of practice, feedback, and reinforcement are key components of learning. Sports training is a useful analogy—the best athletes practice drills daily, often for hours a day, and monitor their performance rigorously—but the same can be said for many other professions, including musicians, chefs, and public speakers.

In medicine, we call seeing patients every day “practice.” But we aren’t practicing if we aren’t getting feedback and improving—we are just performing. None of us can hope to be the Michael Phelps, Yo-Yo Ma, or Grant Achatz of medicine that our patients deserve us to be without real practice.

Human Dx builds on the science of learning by enabling physicians and students to quickly test and get feedback on their clinical reasoning skills. This is done both by receiving input on their own cases as well as giving input on other contributors’ cases to compare their thinking with physicians and students from around the world. Our goal is for Global Morning Report to become the daily personalized workout schedule for doctors everywhere. What I’d like to see is that rigorous practice and pursuit of excellence in clinical reasoning, diagnosis, and management becoming a core part of the physician experience.

Q: What kind of feedback are you hearing from participants?

A: Doctors love it! Many tell us this is their daily Sudoku or crossword that they do every morning to wake their minds up on the way to work. And our numbers show it: The average active participant contributes five cases per week. And today, that’s without any CME credit or other clear reward other than learning and enjoyment.

That said, we have much to improve, and we aren’t resting on our laurels. The whole ethos of the Human Diagnosis Project is created and led by the global medical community. We are lucky to have an incredible community of physicians and trainees globally who keep us moving forward each day.

Q: Why was a partnership with SHM appealing for this project?

A: At Human Dx, we look at ourselves simply as enablers. We are making it possible for the global medical community to come together and build something important for current and future generations. As such, we want to work with the best institutions in medicine to take their expertise, content, and community and make them more available to the world. As one of the largest, fastest growing, and innovative communities in medicine, SHM is an ideal partner, and we count ourselves very fortunate to have your support.

Q: How can hospitalists participate?

A: Start contributing cases! Not every doctor is interested in medical education, technology, or policy, but every physician I know has great cases and insights to share with the world. My hope is that for physicians and medical students, contributing to Human Dx is their 10 minutes a day to be a part of something greater than themselves, allowing them to share their insights with humankind, build a resource for current and future generations, and, in doing so, renew the reasons that brought them to medicine in the first place and find joy in clinical practice. TH

Join the movement today and solve a case now at www.humandx.org/shm.

SHM recently partnered with the Human Diagnosis Project, also referred to as Human Dx, for Global Morning Report. Human Dx is the world’s first open diagnostic system, which aims to understand the fundamental data structure of diagnosis and considerably impact the future cost of, access to, and effectiveness of healthcare globally.

The Hospitalist spoke with Shantanu Nundy, MD, MBA, a primary-care physician for the Human Diagnosis Project, to learn more about its inception and SHM’s partnership.

Question: How did the Global Morning Report project start?

Answer: We were at the University of California, San Francisco (UCSF), working on a morning report with master diagnostician Gurpreet Dhaliwal, MD, when we had an “aha moment” of sorts. Instead of the typical morning report, which uses a whiteboard or slide deck, residents and Dr. Dhaliwal worked through the case using the Human Dx open case collaboration software. At the end of the morning report, the case was tweeted out on social media for anyone in the world to solve, and within minutes, a medical student in Bangladesh not only was able to access the case but also access insights from the UCSF residents and Dr. Dhaliwal. That’s when we realized we were onto something big.

Q: What are the goals of Human Dx and Global Morning Report?

A: Repeated, rapid cycles of practice, feedback, and reinforcement are key components of learning. Sports training is a useful analogy—the best athletes practice drills daily, often for hours a day, and monitor their performance rigorously—but the same can be said for many other professions, including musicians, chefs, and public speakers.

In medicine, we call seeing patients every day “practice.” But we aren’t practicing if we aren’t getting feedback and improving—we are just performing. None of us can hope to be the Michael Phelps, Yo-Yo Ma, or Grant Achatz of medicine that our patients deserve us to be without real practice.

Human Dx builds on the science of learning by enabling physicians and students to quickly test and get feedback on their clinical reasoning skills. This is done both by receiving input on their own cases as well as giving input on other contributors’ cases to compare their thinking with physicians and students from around the world. Our goal is for Global Morning Report to become the daily personalized workout schedule for doctors everywhere. What I’d like to see is that rigorous practice and pursuit of excellence in clinical reasoning, diagnosis, and management becoming a core part of the physician experience.

Q: What kind of feedback are you hearing from participants?

A: Doctors love it! Many tell us this is their daily Sudoku or crossword that they do every morning to wake their minds up on the way to work. And our numbers show it: The average active participant contributes five cases per week. And today, that’s without any CME credit or other clear reward other than learning and enjoyment.

That said, we have much to improve, and we aren’t resting on our laurels. The whole ethos of the Human Diagnosis Project is created and led by the global medical community. We are lucky to have an incredible community of physicians and trainees globally who keep us moving forward each day.

Q: Why was a partnership with SHM appealing for this project?

A: At Human Dx, we look at ourselves simply as enablers. We are making it possible for the global medical community to come together and build something important for current and future generations. As such, we want to work with the best institutions in medicine to take their expertise, content, and community and make them more available to the world. As one of the largest, fastest growing, and innovative communities in medicine, SHM is an ideal partner, and we count ourselves very fortunate to have your support.

Q: How can hospitalists participate?

A: Start contributing cases! Not every doctor is interested in medical education, technology, or policy, but every physician I know has great cases and insights to share with the world. My hope is that for physicians and medical students, contributing to Human Dx is their 10 minutes a day to be a part of something greater than themselves, allowing them to share their insights with humankind, build a resource for current and future generations, and, in doing so, renew the reasons that brought them to medicine in the first place and find joy in clinical practice. TH

Join the movement today and solve a case now at www.humandx.org/shm.

Brentuximab vedotin (Adcetris)

Photo from Business Wire

The US Food and Drug Administration (FDA) has granted breakthrough therapy designation to brentuximab vedotin (Adcetris) as a treatment for 2 subtypes of cutaneous T-cell lymphoma (CTCL).

The drug now has this designation for the treatment of patients with CD30-expressing mycosis fungoides (MF) and patients with primary cutaneous anaplastic large-cell lymphoma (pcALCL) who require systemic therapy and have received 1 prior systemic therapy.

The FDA’s breakthrough therapy designation is intended to expedite the development and review of new treatments for serious or life-threatening conditions.

Breakthrough designation entitles the company developing a therapy to more intensive FDA guidance on an efficient and accelerated development program, as well as eligibility for other actions to expedite FDA review, such as a rolling submission and priority review.

To earn breakthrough designation, a treatment must show encouraging early clinical results demonstrating substantial improvement over available therapies with regard to a clinically significant endpoint, or it must fulfill an unmet need.

Brentuximab vedotin in CTCL

Brentuximab vedotin is an antibody-drug conjugate directed to CD30, which is expressed on skin lesions in approximately 50% of patients with CTCL. The drug is being developed by Seattle Genetics and Takeda Pharmaceutical Company Limited.

Brentuximab vedotin has orphan drug designation from the FDA for the treatment of MF. The drug also received orphan drug designation from the European Commission for CTCL, including subtypes pcALCL and MF.

Brentuximab vedotin has been evaluated in CD30-expressing CTCL in investigator- and corporate-sponsored clinical trials, including the phase 3 ALCANZA trial.

This trial was designed to compare single-agent brentuximab vedotin to investigator’s choice of standard therapies—methotrexate or bexarotene—in patients with CD30-expressing CTCL, including those with pcALCL or MF.

The trial has enrolled 131 patients at 50 sites globally. Patients with pcALCL must have received at least 1 prior systemic or radiation therapy, and patients with MF must have received at least 1 prior systemic therapy.

The study’s primary endpoint is objective response lasting at least 4 months (ORR4), as assessed by Global Response Score, in the brentuximab vedotin arm compared to the control arm. Key secondary endpoints are complete response rate, progression-free survival, and reduction in the burden of symptoms during treatment.

Topline results of the trial were announced in August. The data showed a significant improvement in the ORR4 for the brentuximab vedotin arm compared to the control arm. The ORR4 was 56.3% and 12.5%, respectively (P<0.0001).

The key secondary endpoints were all statistically significant in favor of the brentuximab vedotin arm. And investigators said the safety profile of brentuximab vedotin was generally consistent with the existing prescribing information.

An abstract detailing results of the ALCANZA trial was accepted for oral presentation at the upcoming ASH Annual Meeting (abstract 182).

Brentuximab vedotin (Adcetris)

Photo from Business Wire

The US Food and Drug Administration (FDA) has granted breakthrough therapy designation to brentuximab vedotin (Adcetris) as a treatment for 2 subtypes of cutaneous T-cell lymphoma (CTCL).

The drug now has this designation for the treatment of patients with CD30-expressing mycosis fungoides (MF) and patients with primary cutaneous anaplastic large-cell lymphoma (pcALCL) who require systemic therapy and have received 1 prior systemic therapy.

The FDA’s breakthrough therapy designation is intended to expedite the development and review of new treatments for serious or life-threatening conditions.

Breakthrough designation entitles the company developing a therapy to more intensive FDA guidance on an efficient and accelerated development program, as well as eligibility for other actions to expedite FDA review, such as a rolling submission and priority review.

To earn breakthrough designation, a treatment must show encouraging early clinical results demonstrating substantial improvement over available therapies with regard to a clinically significant endpoint, or it must fulfill an unmet need.

Brentuximab vedotin in CTCL

Brentuximab vedotin is an antibody-drug conjugate directed to CD30, which is expressed on skin lesions in approximately 50% of patients with CTCL. The drug is being developed by Seattle Genetics and Takeda Pharmaceutical Company Limited.

Brentuximab vedotin has orphan drug designation from the FDA for the treatment of MF. The drug also received orphan drug designation from the European Commission for CTCL, including subtypes pcALCL and MF.

Brentuximab vedotin has been evaluated in CD30-expressing CTCL in investigator- and corporate-sponsored clinical trials, including the phase 3 ALCANZA trial.

This trial was designed to compare single-agent brentuximab vedotin to investigator’s choice of standard therapies—methotrexate or bexarotene—in patients with CD30-expressing CTCL, including those with pcALCL or MF.

The trial has enrolled 131 patients at 50 sites globally. Patients with pcALCL must have received at least 1 prior systemic or radiation therapy, and patients with MF must have received at least 1 prior systemic therapy.

The study’s primary endpoint is objective response lasting at least 4 months (ORR4), as assessed by Global Response Score, in the brentuximab vedotin arm compared to the control arm. Key secondary endpoints are complete response rate, progression-free survival, and reduction in the burden of symptoms during treatment.

Topline results of the trial were announced in August. The data showed a significant improvement in the ORR4 for the brentuximab vedotin arm compared to the control arm. The ORR4 was 56.3% and 12.5%, respectively (P<0.0001).

The key secondary endpoints were all statistically significant in favor of the brentuximab vedotin arm. And investigators said the safety profile of brentuximab vedotin was generally consistent with the existing prescribing information.

An abstract detailing results of the ALCANZA trial was accepted for oral presentation at the upcoming ASH Annual Meeting (abstract 182).

Brentuximab vedotin (Adcetris)

Photo from Business Wire

The US Food and Drug Administration (FDA) has granted breakthrough therapy designation to brentuximab vedotin (Adcetris) as a treatment for 2 subtypes of cutaneous T-cell lymphoma (CTCL).

The drug now has this designation for the treatment of patients with CD30-expressing mycosis fungoides (MF) and patients with primary cutaneous anaplastic large-cell lymphoma (pcALCL) who require systemic therapy and have received 1 prior systemic therapy.

The FDA’s breakthrough therapy designation is intended to expedite the development and review of new treatments for serious or life-threatening conditions.

Breakthrough designation entitles the company developing a therapy to more intensive FDA guidance on an efficient and accelerated development program, as well as eligibility for other actions to expedite FDA review, such as a rolling submission and priority review.

To earn breakthrough designation, a treatment must show encouraging early clinical results demonstrating substantial improvement over available therapies with regard to a clinically significant endpoint, or it must fulfill an unmet need.

Brentuximab vedotin in CTCL

Brentuximab vedotin is an antibody-drug conjugate directed to CD30, which is expressed on skin lesions in approximately 50% of patients with CTCL. The drug is being developed by Seattle Genetics and Takeda Pharmaceutical Company Limited.

Brentuximab vedotin has orphan drug designation from the FDA for the treatment of MF. The drug also received orphan drug designation from the European Commission for CTCL, including subtypes pcALCL and MF.

Brentuximab vedotin has been evaluated in CD30-expressing CTCL in investigator- and corporate-sponsored clinical trials, including the phase 3 ALCANZA trial.

This trial was designed to compare single-agent brentuximab vedotin to investigator’s choice of standard therapies—methotrexate or bexarotene—in patients with CD30-expressing CTCL, including those with pcALCL or MF.

The trial has enrolled 131 patients at 50 sites globally. Patients with pcALCL must have received at least 1 prior systemic or radiation therapy, and patients with MF must have received at least 1 prior systemic therapy.

The study’s primary endpoint is objective response lasting at least 4 months (ORR4), as assessed by Global Response Score, in the brentuximab vedotin arm compared to the control arm. Key secondary endpoints are complete response rate, progression-free survival, and reduction in the burden of symptoms during treatment.

Topline results of the trial were announced in August. The data showed a significant improvement in the ORR4 for the brentuximab vedotin arm compared to the control arm. The ORR4 was 56.3% and 12.5%, respectively (P<0.0001).

The key secondary endpoints were all statistically significant in favor of the brentuximab vedotin arm. And investigators said the safety profile of brentuximab vedotin was generally consistent with the existing prescribing information.

An abstract detailing results of the ALCANZA trial was accepted for oral presentation at the upcoming ASH Annual Meeting (abstract 182).

LAS VEGAS – Clinicians should consider the increased risk for multiple comorbidities in their patients with psoriasis, Joel M. Gelfand, MD, said in a video interview at the Skin Disease Education Foundation’s annual Las Vegas Dermatology Seminar.

“These are patients who should undergo the type of age-appropriate screening that any patient should have,” including checks for blood pressure and diabetes, said Dr. Gelfand, professor of dermatology and epidemiology at the University of Pennsylvania, Philadelphia.

In terms of preparing for systemic psoriasis therapy, “there are lots of things we can do to lower the risk of having bad outcomes,” including age-appropriate cancer screening such as colonoscopy and mammography, he added. Vaccination is also an important strategy to help reduce the risk of potential side effects related to immunosuppression, he noted.

Dr. Gelfand disclosed relationships with multiple companies including AbbVie, Celgene, Janssen, Lilly, Merck, Novartis, Pfizer, Sanofi, and Valeant.

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

LAS VEGAS – Clinicians should consider the increased risk for multiple comorbidities in their patients with psoriasis, Joel M. Gelfand, MD, said in a video interview at the Skin Disease Education Foundation’s annual Las Vegas Dermatology Seminar.

“These are patients who should undergo the type of age-appropriate screening that any patient should have,” including checks for blood pressure and diabetes, said Dr. Gelfand, professor of dermatology and epidemiology at the University of Pennsylvania, Philadelphia.

In terms of preparing for systemic psoriasis therapy, “there are lots of things we can do to lower the risk of having bad outcomes,” including age-appropriate cancer screening such as colonoscopy and mammography, he added. Vaccination is also an important strategy to help reduce the risk of potential side effects related to immunosuppression, he noted.

Dr. Gelfand disclosed relationships with multiple companies including AbbVie, Celgene, Janssen, Lilly, Merck, Novartis, Pfizer, Sanofi, and Valeant.

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

LAS VEGAS – Clinicians should consider the increased risk for multiple comorbidities in their patients with psoriasis, Joel M. Gelfand, MD, said in a video interview at the Skin Disease Education Foundation’s annual Las Vegas Dermatology Seminar.

“These are patients who should undergo the type of age-appropriate screening that any patient should have,” including checks for blood pressure and diabetes, said Dr. Gelfand, professor of dermatology and epidemiology at the University of Pennsylvania, Philadelphia.

In terms of preparing for systemic psoriasis therapy, “there are lots of things we can do to lower the risk of having bad outcomes,” including age-appropriate cancer screening such as colonoscopy and mammography, he added. Vaccination is also an important strategy to help reduce the risk of potential side effects related to immunosuppression, he noted.

Dr. Gelfand disclosed relationships with multiple companies including AbbVie, Celgene, Janssen, Lilly, Merck, Novartis, Pfizer, Sanofi, and Valeant.

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

LAS VEGAS – There is reason to be optimistic about biosimilars for treating psoriasis, Bruce E. Strober, MD, PhD, said at the Skin Disease Education Foundation’s annual Las Vegas Dermatology Seminar.

To date, the Food and Drug Administration has approved three biosimilar versions of agents used to treat psoriasis: adalimumab, infliximab, and etanercept.

“The biosimilar development and approval pathway is quite rigorous,” said Dr. Strober, professor and chair of the department of dermatology at the University of Connecticut, Farmington, in a video interview. Although none are yet available, “I can say with high confidence that biosimilar molecules are very comparable,” to the reference molecules, he said.

The impact of biosimilars on the market in the United States in terms of cost and access remains to be seen, Dr, Strober added.

However, “I do believe the science and the clinical trials process and the regulatory process are good,” and that, if clinicians had to use biosimilars for their patients, the patient experience would be safe and effective, he noted.

Dr. Strober disclosed relationships with multiple companies including AbbVie, Amgen, Boehringer Ingelheim, Celgene, Dermira, GlaxoSmithKline, Merck, Novartis, and Pfizer.

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

LAS VEGAS – There is reason to be optimistic about biosimilars for treating psoriasis, Bruce E. Strober, MD, PhD, said at the Skin Disease Education Foundation’s annual Las Vegas Dermatology Seminar.

To date, the Food and Drug Administration has approved three biosimilar versions of agents used to treat psoriasis: adalimumab, infliximab, and etanercept.

“The biosimilar development and approval pathway is quite rigorous,” said Dr. Strober, professor and chair of the department of dermatology at the University of Connecticut, Farmington, in a video interview. Although none are yet available, “I can say with high confidence that biosimilar molecules are very comparable,” to the reference molecules, he said.

The impact of biosimilars on the market in the United States in terms of cost and access remains to be seen, Dr, Strober added.

However, “I do believe the science and the clinical trials process and the regulatory process are good,” and that, if clinicians had to use biosimilars for their patients, the patient experience would be safe and effective, he noted.

Dr. Strober disclosed relationships with multiple companies including AbbVie, Amgen, Boehringer Ingelheim, Celgene, Dermira, GlaxoSmithKline, Merck, Novartis, and Pfizer.

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

LAS VEGAS – There is reason to be optimistic about biosimilars for treating psoriasis, Bruce E. Strober, MD, PhD, said at the Skin Disease Education Foundation’s annual Las Vegas Dermatology Seminar.

To date, the Food and Drug Administration has approved three biosimilar versions of agents used to treat psoriasis: adalimumab, infliximab, and etanercept.

“The biosimilar development and approval pathway is quite rigorous,” said Dr. Strober, professor and chair of the department of dermatology at the University of Connecticut, Farmington, in a video interview. Although none are yet available, “I can say with high confidence that biosimilar molecules are very comparable,” to the reference molecules, he said.

The impact of biosimilars on the market in the United States in terms of cost and access remains to be seen, Dr, Strober added.

However, “I do believe the science and the clinical trials process and the regulatory process are good,” and that, if clinicians had to use biosimilars for their patients, the patient experience would be safe and effective, he noted.

Dr. Strober disclosed relationships with multiple companies including AbbVie, Amgen, Boehringer Ingelheim, Celgene, Dermira, GlaxoSmithKline, Merck, Novartis, and Pfizer.

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

While anti–tumor necrosis factor (TNF)-alpha medications have shown effectiveness for psoriasis, ongoing issues include optimizing therapy, managing treatment in special populations, and comparing the drugs with newer therapies, according to Dr. Francisco A. Kerdel.

Among the concerns regarding optimizing anti–TNF-alpha therapy are loss of response, continuous versus intermittent dosing, combination therapy, and long-term safety and efficacy, Dr. Kerdel, professor and vice-chair of the department of dermatology, Florida International University, Miami, said in a presentation at the Skin Disease Education Foundation’s annual Las Vegas Dermatology Seminar.

University of Miami

While anti–tumor necrosis factor (TNF)-alpha medications have shown effectiveness for psoriasis, ongoing issues include optimizing therapy, managing treatment in special populations, and comparing the drugs with newer therapies, according to Dr. Francisco A. Kerdel.

Among the concerns regarding optimizing anti–TNF-alpha therapy are loss of response, continuous versus intermittent dosing, combination therapy, and long-term safety and efficacy, Dr. Kerdel, professor and vice-chair of the department of dermatology, Florida International University, Miami, said in a presentation at the Skin Disease Education Foundation’s annual Las Vegas Dermatology Seminar.

University of Miami

While anti–tumor necrosis factor (TNF)-alpha medications have shown effectiveness for psoriasis, ongoing issues include optimizing therapy, managing treatment in special populations, and comparing the drugs with newer therapies, according to Dr. Francisco A. Kerdel.

Among the concerns regarding optimizing anti–TNF-alpha therapy are loss of response, continuous versus intermittent dosing, combination therapy, and long-term safety and efficacy, Dr. Kerdel, professor and vice-chair of the department of dermatology, Florida International University, Miami, said in a presentation at the Skin Disease Education Foundation’s annual Las Vegas Dermatology Seminar.

University of Miami

LAS VEGAS – Interleukin-23 (IL-23) inhibitors, currently in the pipeline for treating psoriasis, are showing great promise for the treatment of the disease, Bruce E. Strober, MD, PhD, said in a video interview at the Skin Disease Education Foundation’s Las Vegas Dermatology Seminar.

“There likely will be at least three, if not four, IL-23 inhibitors, all biologics, approved within the next 5 years,” said Dr. Strober, professor and chair of the department of dermatology at the University of Connecticut Health Center, Farmington. “The IL-23 inhibitors are specific, and they seem to be delivering as good or better efficacy than ustekinumab,” with the potential for longer dosing intervals, depending on the patient, he noted.

Dr. Strober disclosed relationships with multiple companies including AbbVie, Amgen, Boehringer Ingelheim, Celgene, Dermira, GlaxoSmithKline, Merck, Novartis, and Pfizer.

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

LAS VEGAS – Interleukin-23 (IL-23) inhibitors, currently in the pipeline for treating psoriasis, are showing great promise for the treatment of the disease, Bruce E. Strober, MD, PhD, said in a video interview at the Skin Disease Education Foundation’s Las Vegas Dermatology Seminar.

“There likely will be at least three, if not four, IL-23 inhibitors, all biologics, approved within the next 5 years,” said Dr. Strober, professor and chair of the department of dermatology at the University of Connecticut Health Center, Farmington. “The IL-23 inhibitors are specific, and they seem to be delivering as good or better efficacy than ustekinumab,” with the potential for longer dosing intervals, depending on the patient, he noted.

Dr. Strober disclosed relationships with multiple companies including AbbVie, Amgen, Boehringer Ingelheim, Celgene, Dermira, GlaxoSmithKline, Merck, Novartis, and Pfizer.

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

LAS VEGAS – Interleukin-23 (IL-23) inhibitors, currently in the pipeline for treating psoriasis, are showing great promise for the treatment of the disease, Bruce E. Strober, MD, PhD, said in a video interview at the Skin Disease Education Foundation’s Las Vegas Dermatology Seminar.

“There likely will be at least three, if not four, IL-23 inhibitors, all biologics, approved within the next 5 years,” said Dr. Strober, professor and chair of the department of dermatology at the University of Connecticut Health Center, Farmington. “The IL-23 inhibitors are specific, and they seem to be delivering as good or better efficacy than ustekinumab,” with the potential for longer dosing intervals, depending on the patient, he noted.

Dr. Strober disclosed relationships with multiple companies including AbbVie, Amgen, Boehringer Ingelheim, Celgene, Dermira, GlaxoSmithKline, Merck, Novartis, and Pfizer.

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

As a chronic inflammatory skin disease well known for its poor cosmesis including scarring, residual macular erythema, and postinflammatory pigment alteration, acne vulgaris may, according to recent research, confer some antiaging benefits to affected patients. In a research letter published online on September 27 in the Journal of Investigative Dermatology, Ribero et al analyzed white blood cells and found that women who said they had acne had longer telomeres (the "caps" at the end of chromosomes that protect them from deteriorating following repeated cell replication). Telomere length, or rather shortening, has been correlated with age-related degenerative change, according to Saum et al (Exp Gerontol. 2014;58:250-255), and therefore the thinking is that in women with acne, something is going on that maintains the length of the cellular guardians. Let's clarify a couple things to help us all understand the why and what.

The impetus of this study, according to Ribero et al, was the observation that women with acne show signs of aging later than those who have never had acne. I personally have not witnessed this finding in my patients, and given that acne in its essence is a disease of chronic inflammation resulting from, for example, persistent activation of toll-like receptor 2 (TLR2) and NOD-like receptor family pyrin domain containing 3 (NLRP3) pattern recognition receptors, one would think the skin damage accrued would make these individuals look older, right? Last I checked, pitted scarring does not make one immediately think of the fountain of youth.

The results from the study show that there is a link between acne and longer telomeres, but the study did not show that telomere length is a cause of acne, that women with longer telomeres had fewer signs of skin aging, or that women with acne lived longer.

Given these points, Ribero et al concluded that "delayed skin aging may be due to reduced senescence," which means that skin aging may be delayed because the longer telomeres in the cells protect them from deterioration. They did find that the expression of one gene in particular was reduced in women with acne--the regulatory gene zinc finger protein 420, ZNF420--suggesting that those without acne may produce more of a particular protein linked to that gene, though the significance is unclear.

What's the issue?

This study is interesting, but it is important not to make any broad conclusions, such as those who get acne will live longer or look younger longer regardless of other factors such as acne treatment, comorbidities, or even environmental factors. This study may give more support for the genetic contribution of acne, but much more work is needed to determine the clinical relevance. For starters, what about men?

Would you assure your acne patients that their disease may be for their own cosmetic good?

We want to know your views! Tell us what you think.

As a chronic inflammatory skin disease well known for its poor cosmesis including scarring, residual macular erythema, and postinflammatory pigment alteration, acne vulgaris may, according to recent research, confer some antiaging benefits to affected patients. In a research letter published online on September 27 in the Journal of Investigative Dermatology, Ribero et al analyzed white blood cells and found that women who said they had acne had longer telomeres (the "caps" at the end of chromosomes that protect them from deteriorating following repeated cell replication). Telomere length, or rather shortening, has been correlated with age-related degenerative change, according to Saum et al (Exp Gerontol. 2014;58:250-255), and therefore the thinking is that in women with acne, something is going on that maintains the length of the cellular guardians. Let's clarify a couple things to help us all understand the why and what.

The impetus of this study, according to Ribero et al, was the observation that women with acne show signs of aging later than those who have never had acne. I personally have not witnessed this finding in my patients, and given that acne in its essence is a disease of chronic inflammation resulting from, for example, persistent activation of toll-like receptor 2 (TLR2) and NOD-like receptor family pyrin domain containing 3 (NLRP3) pattern recognition receptors, one would think the skin damage accrued would make these individuals look older, right? Last I checked, pitted scarring does not make one immediately think of the fountain of youth.

The results from the study show that there is a link between acne and longer telomeres, but the study did not show that telomere length is a cause of acne, that women with longer telomeres had fewer signs of skin aging, or that women with acne lived longer.

Given these points, Ribero et al concluded that "delayed skin aging may be due to reduced senescence," which means that skin aging may be delayed because the longer telomeres in the cells protect them from deterioration. They did find that the expression of one gene in particular was reduced in women with acne--the regulatory gene zinc finger protein 420, ZNF420--suggesting that those without acne may produce more of a particular protein linked to that gene, though the significance is unclear.

What's the issue?

This study is interesting, but it is important not to make any broad conclusions, such as those who get acne will live longer or look younger longer regardless of other factors such as acne treatment, comorbidities, or even environmental factors. This study may give more support for the genetic contribution of acne, but much more work is needed to determine the clinical relevance. For starters, what about men?

Would you assure your acne patients that their disease may be for their own cosmetic good?

We want to know your views! Tell us what you think.

As a chronic inflammatory skin disease well known for its poor cosmesis including scarring, residual macular erythema, and postinflammatory pigment alteration, acne vulgaris may, according to recent research, confer some antiaging benefits to affected patients. In a research letter published online on September 27 in the Journal of Investigative Dermatology, Ribero et al analyzed white blood cells and found that women who said they had acne had longer telomeres (the "caps" at the end of chromosomes that protect them from deteriorating following repeated cell replication). Telomere length, or rather shortening, has been correlated with age-related degenerative change, according to Saum et al (Exp Gerontol. 2014;58:250-255), and therefore the thinking is that in women with acne, something is going on that maintains the length of the cellular guardians. Let's clarify a couple things to help us all understand the why and what.

The impetus of this study, according to Ribero et al, was the observation that women with acne show signs of aging later than those who have never had acne. I personally have not witnessed this finding in my patients, and given that acne in its essence is a disease of chronic inflammation resulting from, for example, persistent activation of toll-like receptor 2 (TLR2) and NOD-like receptor family pyrin domain containing 3 (NLRP3) pattern recognition receptors, one would think the skin damage accrued would make these individuals look older, right? Last I checked, pitted scarring does not make one immediately think of the fountain of youth.

The results from the study show that there is a link between acne and longer telomeres, but the study did not show that telomere length is a cause of acne, that women with longer telomeres had fewer signs of skin aging, or that women with acne lived longer.

Given these points, Ribero et al concluded that "delayed skin aging may be due to reduced senescence," which means that skin aging may be delayed because the longer telomeres in the cells protect them from deterioration. They did find that the expression of one gene in particular was reduced in women with acne--the regulatory gene zinc finger protein 420, ZNF420--suggesting that those without acne may produce more of a particular protein linked to that gene, though the significance is unclear.

What's the issue?

This study is interesting, but it is important not to make any broad conclusions, such as those who get acne will live longer or look younger longer regardless of other factors such as acne treatment, comorbidities, or even environmental factors. This study may give more support for the genetic contribution of acne, but much more work is needed to determine the clinical relevance. For starters, what about men?

Would you assure your acne patients that their disease may be for their own cosmetic good?

We want to know your views! Tell us what you think.

While associations are known to exist between primary biliary cholangitis (PBC) and many different types of thyroid disease (TD), a new study shows that the mere presence of thyroid disease does not have any bearing on the hepatic complications or progression of PBC.

“The prevalence of TD in PBC reportedly ranges between 7.24% and 14.4%, the most often encountered thyroid dysfunction being Hashimoto’s thyroiditis,” wrote the study’s authors, led by Annarosa Floreani, MD, of the University of Padua (Italy).

Sebastian Kaulitzki/Fotolia

Of the 921 total patients enrolled, 150 (16.3%) had TD. The most common TD patients had were Hashimoto’s thyroiditis, which 94 (10.2%) individuals had; Graves’ disease, found in 15 (1.6%) patients; multinodular goiter, which 22 (2.4%) patients had; thyroid cancer, which was found in 7 (0.8%); and “other thyroid conditions,” which affected 12 (1.3%) patients. Patients from Padua had significantly more Graves’ disease and thyroid cancer than those from Barcelona: 11 (15.7%) versus 4 (5.0%) for Graves’ (P = .03), and 6 (8.6%) versus 1 (1.3%) for thyroid cancer (P = .03), respectively. However, no significant differences were found in PBC patients who had TD and those who did not, when it came to comparing the histologic stages at which they were diagnosed with PBC, hepatic decompensation events, occurrence of hepatocellular carcinoma, or liver transplantation rate. Furthermore, TD was not found to affect PBC survival rates, either positively or negatively.

“The results of our study confirm that TDs are often associated with PBC, especially Hashimoto’s thyroiditis, which shares an autoimmune etiology with PBC,” the authors concluded, adding that “More importantly … the clinical characteristics and natural history of PBC were much the same in the two cohorts, as demonstrated by the absence of significant differences regarding histological stage at diagnosis (the only exception being more patients in stage III in the Italian cohort); biochemical data; response to UDCA [ursodeoxycholic acid]; the association with other extrahepatic autoimmune disorders; the occurrence of clinical events; and survival.”

No funding source was reported for this study. Dr. Floreani and her coauthors did not report any financial disclosures relevant to this study.

[email protected]

While associations are known to exist between primary biliary cholangitis (PBC) and many different types of thyroid disease (TD), a new study shows that the mere presence of thyroid disease does not have any bearing on the hepatic complications or progression of PBC.

“The prevalence of TD in PBC reportedly ranges between 7.24% and 14.4%, the most often encountered thyroid dysfunction being Hashimoto’s thyroiditis,” wrote the study’s authors, led by Annarosa Floreani, MD, of the University of Padua (Italy).

Sebastian Kaulitzki/Fotolia

Of the 921 total patients enrolled, 150 (16.3%) had TD. The most common TD patients had were Hashimoto’s thyroiditis, which 94 (10.2%) individuals had; Graves’ disease, found in 15 (1.6%) patients; multinodular goiter, which 22 (2.4%) patients had; thyroid cancer, which was found in 7 (0.8%); and “other thyroid conditions,” which affected 12 (1.3%) patients. Patients from Padua had significantly more Graves’ disease and thyroid cancer than those from Barcelona: 11 (15.7%) versus 4 (5.0%) for Graves’ (P = .03), and 6 (8.6%) versus 1 (1.3%) for thyroid cancer (P = .03), respectively. However, no significant differences were found in PBC patients who had TD and those who did not, when it came to comparing the histologic stages at which they were diagnosed with PBC, hepatic decompensation events, occurrence of hepatocellular carcinoma, or liver transplantation rate. Furthermore, TD was not found to affect PBC survival rates, either positively or negatively.

“The results of our study confirm that TDs are often associated with PBC, especially Hashimoto’s thyroiditis, which shares an autoimmune etiology with PBC,” the authors concluded, adding that “More importantly … the clinical characteristics and natural history of PBC were much the same in the two cohorts, as demonstrated by the absence of significant differences regarding histological stage at diagnosis (the only exception being more patients in stage III in the Italian cohort); biochemical data; response to UDCA [ursodeoxycholic acid]; the association with other extrahepatic autoimmune disorders; the occurrence of clinical events; and survival.”

No funding source was reported for this study. Dr. Floreani and her coauthors did not report any financial disclosures relevant to this study.

[email protected]

While associations are known to exist between primary biliary cholangitis (PBC) and many different types of thyroid disease (TD), a new study shows that the mere presence of thyroid disease does not have any bearing on the hepatic complications or progression of PBC.

“The prevalence of TD in PBC reportedly ranges between 7.24% and 14.4%, the most often encountered thyroid dysfunction being Hashimoto’s thyroiditis,” wrote the study’s authors, led by Annarosa Floreani, MD, of the University of Padua (Italy).

Sebastian Kaulitzki/Fotolia

Of the 921 total patients enrolled, 150 (16.3%) had TD. The most common TD patients had were Hashimoto’s thyroiditis, which 94 (10.2%) individuals had; Graves’ disease, found in 15 (1.6%) patients; multinodular goiter, which 22 (2.4%) patients had; thyroid cancer, which was found in 7 (0.8%); and “other thyroid conditions,” which affected 12 (1.3%) patients. Patients from Padua had significantly more Graves’ disease and thyroid cancer than those from Barcelona: 11 (15.7%) versus 4 (5.0%) for Graves’ (P = .03), and 6 (8.6%) versus 1 (1.3%) for thyroid cancer (P = .03), respectively. However, no significant differences were found in PBC patients who had TD and those who did not, when it came to comparing the histologic stages at which they were diagnosed with PBC, hepatic decompensation events, occurrence of hepatocellular carcinoma, or liver transplantation rate. Furthermore, TD was not found to affect PBC survival rates, either positively or negatively.

“The results of our study confirm that TDs are often associated with PBC, especially Hashimoto’s thyroiditis, which shares an autoimmune etiology with PBC,” the authors concluded, adding that “More importantly … the clinical characteristics and natural history of PBC were much the same in the two cohorts, as demonstrated by the absence of significant differences regarding histological stage at diagnosis (the only exception being more patients in stage III in the Italian cohort); biochemical data; response to UDCA [ursodeoxycholic acid]; the association with other extrahepatic autoimmune disorders; the occurrence of clinical events; and survival.”

No funding source was reported for this study. Dr. Floreani and her coauthors did not report any financial disclosures relevant to this study.

[email protected]

Studies of drug-coated balloons in the lower extremities need to evolve to take a more nuanced look at outcomes, in part by incorporating more patient-centric endpoints, says a leading global expert on DCBs.

Dr. Marianne Brodmann of the University of Ganz, Austria, and a frequent principal investigator on endovascular trials, makes the case Saturday morning that it cannot be assumed that all DCBs are equally effective – though current trial and registry evidence, with their limited efficacy endpoints, make this somewhat hard to see.

“We have to step away from the philosophy we had in the past that a mechanical device like a balloon is a balloon, and therefore the same as any other balloon. When you add a drug, you have to prove the drug is working,” Dr. Brodmann said.

Studies of drug-coated balloons in the lower extremities need to evolve to take a more nuanced look at outcomes, in part by incorporating more patient-centric endpoints, says a leading global expert on DCBs.

Dr. Marianne Brodmann of the University of Ganz, Austria, and a frequent principal investigator on endovascular trials, makes the case Saturday morning that it cannot be assumed that all DCBs are equally effective – though current trial and registry evidence, with their limited efficacy endpoints, make this somewhat hard to see.

“We have to step away from the philosophy we had in the past that a mechanical device like a balloon is a balloon, and therefore the same as any other balloon. When you add a drug, you have to prove the drug is working,” Dr. Brodmann said.

Studies of drug-coated balloons in the lower extremities need to evolve to take a more nuanced look at outcomes, in part by incorporating more patient-centric endpoints, says a leading global expert on DCBs.

Dr. Marianne Brodmann of the University of Ganz, Austria, and a frequent principal investigator on endovascular trials, makes the case Saturday morning that it cannot be assumed that all DCBs are equally effective – though current trial and registry evidence, with their limited efficacy endpoints, make this somewhat hard to see.

“We have to step away from the philosophy we had in the past that a mechanical device like a balloon is a balloon, and therefore the same as any other balloon. When you add a drug, you have to prove the drug is working,” Dr. Brodmann said.