A version of this article first appeared on WebMD.com.

A version of this article first appeared on WebMD.com.

A version of this article first appeared on WebMD.com.

There is a dangerous trend in our country in which employers, seeking to reduce health plan costs they pay, enter into agreements with small third-party administrators that “carve out” specialty drug benefits from their self-funded health insurance plan. What employers are not told is that these spending reductions are accomplished by risking the health of their employees. It is the self-funded businesses that are being preyed upon by these administrators because there is a lot of money to be made by carving out the specialty drugs in their self-funded health plan.

Let’s start with a little primer on “fully insured” versus “self-funded” health plans. As a small business owner, I understand the need to make sure that expenses don’t outpace revenue if I want to keep my doors open. One of the largest expenses for any business is health insurance. My private rheumatology practice uses a fully insured health plan. In a fully insured plan, the insurer is the party taking the financial risk. We pay the premiums, and the insurance company pays the bills after the deductible is met. It may cost more in premiums than a self-funded plan, but if an employee has an accident or severe illness, our practice is not responsible for the cost of care.

On the other hand, large and small businesses that are self-funded cover the health costs of their employees themselves. These businesses will hire a third-party administrator to pay the bills out of an account that is supplied with money from the business owner. Looking at the insurance card of your patient is one way to tell if they are covered by a fully insured or self-funded plan. If the insurance card says the plan is “administered by” the insurer or “administrative services only,” it is most likely a self-funded plan. If their insurance card states “underwritten by” the insurer on the card then it is likely a fully insured plan. This becomes important because self-funded plans are not subject to the jurisdiction of state laws such as utilization management reform. These state laws are preempted from applying to self-funded plans by the Employee Retirement Income Security Act of 1974. The Rutledge v. Pharmaceutical Care Management Association Supreme Court case took up the question of whether certain state laws impermissibly applied or were connected to self-funded plans. The ruling in favor of Rutledge opens the door that certain state legislation may one day apply to self-funded plans.
 

Specialty drug benefit carve outs are not in best interests of employees, employers

This piece is not about Rutledge but about the small third-party administrators that are convincing self-funded businesses to let them “carve out” specialty drug benefits from the larger administrator of the plan by promising huge savings in the employer’s specialty drug spending. Two such companies that have come to the attention of the Coalition of State Rheumatology Organizations are Vivio Health and Archimedes. CSRO has received numerous complaints from rheumatologists regarding interference from these two entities with their clinical decision making and disregard for standard of care.

Vivio’s website reveals a disturbing approach to cost reduction. The website states that Vivio profiles physicians through ProPublica and Open Payments to determine if they are prescribing for the right reason and not for self-interest. This serves as an attempt to set up mistrust of the physician by the employer. Vivio’s website also states that the Food and Drug Administration has declining standards for approval of drugs, and consequently many approved drugs should be considered “experimental.” They say that business owners should not have to pay for “experimental” treatments. Through conversation with Vivio, it appears they believe that oncologists could be replaced by a primary care physician with the right algorithm.

Many of Vivio’s egregious behaviors are enumerated in our letter to Vivio: outrageous nonmedical switches, mandatory biologic tapering, and site of care changes. In all of the complaints that we received, Vivio attempted to switch patients to the same infusible medication, Renflexis, and also mandated white bagging, which means the payer has a specialty pharmacy ship a patient’s medication directly to the physician’s office for administration. This switch was made regardless of the mechanism of action or route of administration of the drug that had stabilized the patient. Peer-to-peer reviews with a retired radiologist led to routinely denied appeals and would even force the patient to a different site of care if the rheumatologist refused the new treatment or the mandated white bagging.

Our letter resulted in two conversations with Vivio. Vivio insisted that it was using American College of Rheumatology guidelines and comparisons between drug studies to make these decisions. The company stated that patients can be switched to any drug that has the same ACR 20, 50, and 70 response criteria outcomes as the drug that they are presently taking, even though these sorts of comparisons of results across completely different studies are invalid for a number of reasons, including because they do not have the same patient populations, protocols, and inclusion/exclusion criteria. These are dangerous policies and thus far we have not been able to find any rheumatologists who have gone along with these demands.

Companies such as Vivio are spreading, and employers are unaware that their policies are only paying lip service to “individualized care” while maintaining an approach to patient care that is focused only on cost cutting. Indeed, Archimedes represents one such metastasis. Their practices are similar to those of Vivio and of which CSRO has received complaints. Archimedes has similarly attempted to mandate white-bagging for the enrollees it manages and switch stable patients for nonmedical reasons to an entirely different molecule and mechanism of action.

Business owners do not understand the harm that these policies can cause their employees. This harm increases downstream medical spending as a result of loss of control of disease activity.

This is a call to action for all advocates and advocacy groups to get in the room with employer/business groups and explain how these third-party administrators, carving out specialty drug benefits, can ultimately cause physical harm to employees and increase monetary cost to the employer in the long run. Rheumatology as a specialty needs to educate employers and work out ways to save money for them and, at the same time, maintain excellence in care for their employees. CSRO has a letter it used successfully with the human resources department of Edward Jones to effect a change in its policies on this matter, which you are welcome to use to craft your own to businesses.

Dr. Feldman is a rheumatologist in private practice with The Rheumatology Group in New Orleans. She is President of the CSRO, past chair of the Alliance for Safe Biologic Medicines, and a past member of the American College of Rheumatology insurance subcommittee. You can reach her at [email protected].

There is a dangerous trend in our country in which employers, seeking to reduce health plan costs they pay, enter into agreements with small third-party administrators that “carve out” specialty drug benefits from their self-funded health insurance plan. What employers are not told is that these spending reductions are accomplished by risking the health of their employees. It is the self-funded businesses that are being preyed upon by these administrators because there is a lot of money to be made by carving out the specialty drugs in their self-funded health plan.

Let’s start with a little primer on “fully insured” versus “self-funded” health plans. As a small business owner, I understand the need to make sure that expenses don’t outpace revenue if I want to keep my doors open. One of the largest expenses for any business is health insurance. My private rheumatology practice uses a fully insured health plan. In a fully insured plan, the insurer is the party taking the financial risk. We pay the premiums, and the insurance company pays the bills after the deductible is met. It may cost more in premiums than a self-funded plan, but if an employee has an accident or severe illness, our practice is not responsible for the cost of care.

On the other hand, large and small businesses that are self-funded cover the health costs of their employees themselves. These businesses will hire a third-party administrator to pay the bills out of an account that is supplied with money from the business owner. Looking at the insurance card of your patient is one way to tell if they are covered by a fully insured or self-funded plan. If the insurance card says the plan is “administered by” the insurer or “administrative services only,” it is most likely a self-funded plan. If their insurance card states “underwritten by” the insurer on the card then it is likely a fully insured plan. This becomes important because self-funded plans are not subject to the jurisdiction of state laws such as utilization management reform. These state laws are preempted from applying to self-funded plans by the Employee Retirement Income Security Act of 1974. The Rutledge v. Pharmaceutical Care Management Association Supreme Court case took up the question of whether certain state laws impermissibly applied or were connected to self-funded plans. The ruling in favor of Rutledge opens the door that certain state legislation may one day apply to self-funded plans.
 

Specialty drug benefit carve outs are not in best interests of employees, employers

This piece is not about Rutledge but about the small third-party administrators that are convincing self-funded businesses to let them “carve out” specialty drug benefits from the larger administrator of the plan by promising huge savings in the employer’s specialty drug spending. Two such companies that have come to the attention of the Coalition of State Rheumatology Organizations are Vivio Health and Archimedes. CSRO has received numerous complaints from rheumatologists regarding interference from these two entities with their clinical decision making and disregard for standard of care.

Vivio’s website reveals a disturbing approach to cost reduction. The website states that Vivio profiles physicians through ProPublica and Open Payments to determine if they are prescribing for the right reason and not for self-interest. This serves as an attempt to set up mistrust of the physician by the employer. Vivio’s website also states that the Food and Drug Administration has declining standards for approval of drugs, and consequently many approved drugs should be considered “experimental.” They say that business owners should not have to pay for “experimental” treatments. Through conversation with Vivio, it appears they believe that oncologists could be replaced by a primary care physician with the right algorithm.

Many of Vivio’s egregious behaviors are enumerated in our letter to Vivio: outrageous nonmedical switches, mandatory biologic tapering, and site of care changes. In all of the complaints that we received, Vivio attempted to switch patients to the same infusible medication, Renflexis, and also mandated white bagging, which means the payer has a specialty pharmacy ship a patient’s medication directly to the physician’s office for administration. This switch was made regardless of the mechanism of action or route of administration of the drug that had stabilized the patient. Peer-to-peer reviews with a retired radiologist led to routinely denied appeals and would even force the patient to a different site of care if the rheumatologist refused the new treatment or the mandated white bagging.

Our letter resulted in two conversations with Vivio. Vivio insisted that it was using American College of Rheumatology guidelines and comparisons between drug studies to make these decisions. The company stated that patients can be switched to any drug that has the same ACR 20, 50, and 70 response criteria outcomes as the drug that they are presently taking, even though these sorts of comparisons of results across completely different studies are invalid for a number of reasons, including because they do not have the same patient populations, protocols, and inclusion/exclusion criteria. These are dangerous policies and thus far we have not been able to find any rheumatologists who have gone along with these demands.

Companies such as Vivio are spreading, and employers are unaware that their policies are only paying lip service to “individualized care” while maintaining an approach to patient care that is focused only on cost cutting. Indeed, Archimedes represents one such metastasis. Their practices are similar to those of Vivio and of which CSRO has received complaints. Archimedes has similarly attempted to mandate white-bagging for the enrollees it manages and switch stable patients for nonmedical reasons to an entirely different molecule and mechanism of action.

Business owners do not understand the harm that these policies can cause their employees. This harm increases downstream medical spending as a result of loss of control of disease activity.

This is a call to action for all advocates and advocacy groups to get in the room with employer/business groups and explain how these third-party administrators, carving out specialty drug benefits, can ultimately cause physical harm to employees and increase monetary cost to the employer in the long run. Rheumatology as a specialty needs to educate employers and work out ways to save money for them and, at the same time, maintain excellence in care for their employees. CSRO has a letter it used successfully with the human resources department of Edward Jones to effect a change in its policies on this matter, which you are welcome to use to craft your own to businesses.

Dr. Feldman is a rheumatologist in private practice with The Rheumatology Group in New Orleans. She is President of the CSRO, past chair of the Alliance for Safe Biologic Medicines, and a past member of the American College of Rheumatology insurance subcommittee. You can reach her at [email protected].

There is a dangerous trend in our country in which employers, seeking to reduce health plan costs they pay, enter into agreements with small third-party administrators that “carve out” specialty drug benefits from their self-funded health insurance plan. What employers are not told is that these spending reductions are accomplished by risking the health of their employees. It is the self-funded businesses that are being preyed upon by these administrators because there is a lot of money to be made by carving out the specialty drugs in their self-funded health plan.

Let’s start with a little primer on “fully insured” versus “self-funded” health plans. As a small business owner, I understand the need to make sure that expenses don’t outpace revenue if I want to keep my doors open. One of the largest expenses for any business is health insurance. My private rheumatology practice uses a fully insured health plan. In a fully insured plan, the insurer is the party taking the financial risk. We pay the premiums, and the insurance company pays the bills after the deductible is met. It may cost more in premiums than a self-funded plan, but if an employee has an accident or severe illness, our practice is not responsible for the cost of care.

On the other hand, large and small businesses that are self-funded cover the health costs of their employees themselves. These businesses will hire a third-party administrator to pay the bills out of an account that is supplied with money from the business owner. Looking at the insurance card of your patient is one way to tell if they are covered by a fully insured or self-funded plan. If the insurance card says the plan is “administered by” the insurer or “administrative services only,” it is most likely a self-funded plan. If their insurance card states “underwritten by” the insurer on the card then it is likely a fully insured plan. This becomes important because self-funded plans are not subject to the jurisdiction of state laws such as utilization management reform. These state laws are preempted from applying to self-funded plans by the Employee Retirement Income Security Act of 1974. The Rutledge v. Pharmaceutical Care Management Association Supreme Court case took up the question of whether certain state laws impermissibly applied or were connected to self-funded plans. The ruling in favor of Rutledge opens the door that certain state legislation may one day apply to self-funded plans.
 

Specialty drug benefit carve outs are not in best interests of employees, employers

This piece is not about Rutledge but about the small third-party administrators that are convincing self-funded businesses to let them “carve out” specialty drug benefits from the larger administrator of the plan by promising huge savings in the employer’s specialty drug spending. Two such companies that have come to the attention of the Coalition of State Rheumatology Organizations are Vivio Health and Archimedes. CSRO has received numerous complaints from rheumatologists regarding interference from these two entities with their clinical decision making and disregard for standard of care.

Vivio’s website reveals a disturbing approach to cost reduction. The website states that Vivio profiles physicians through ProPublica and Open Payments to determine if they are prescribing for the right reason and not for self-interest. This serves as an attempt to set up mistrust of the physician by the employer. Vivio’s website also states that the Food and Drug Administration has declining standards for approval of drugs, and consequently many approved drugs should be considered “experimental.” They say that business owners should not have to pay for “experimental” treatments. Through conversation with Vivio, it appears they believe that oncologists could be replaced by a primary care physician with the right algorithm.

Many of Vivio’s egregious behaviors are enumerated in our letter to Vivio: outrageous nonmedical switches, mandatory biologic tapering, and site of care changes. In all of the complaints that we received, Vivio attempted to switch patients to the same infusible medication, Renflexis, and also mandated white bagging, which means the payer has a specialty pharmacy ship a patient’s medication directly to the physician’s office for administration. This switch was made regardless of the mechanism of action or route of administration of the drug that had stabilized the patient. Peer-to-peer reviews with a retired radiologist led to routinely denied appeals and would even force the patient to a different site of care if the rheumatologist refused the new treatment or the mandated white bagging.

Our letter resulted in two conversations with Vivio. Vivio insisted that it was using American College of Rheumatology guidelines and comparisons between drug studies to make these decisions. The company stated that patients can be switched to any drug that has the same ACR 20, 50, and 70 response criteria outcomes as the drug that they are presently taking, even though these sorts of comparisons of results across completely different studies are invalid for a number of reasons, including because they do not have the same patient populations, protocols, and inclusion/exclusion criteria. These are dangerous policies and thus far we have not been able to find any rheumatologists who have gone along with these demands.

Companies such as Vivio are spreading, and employers are unaware that their policies are only paying lip service to “individualized care” while maintaining an approach to patient care that is focused only on cost cutting. Indeed, Archimedes represents one such metastasis. Their practices are similar to those of Vivio and of which CSRO has received complaints. Archimedes has similarly attempted to mandate white-bagging for the enrollees it manages and switch stable patients for nonmedical reasons to an entirely different molecule and mechanism of action.

Business owners do not understand the harm that these policies can cause their employees. This harm increases downstream medical spending as a result of loss of control of disease activity.

This is a call to action for all advocates and advocacy groups to get in the room with employer/business groups and explain how these third-party administrators, carving out specialty drug benefits, can ultimately cause physical harm to employees and increase monetary cost to the employer in the long run. Rheumatology as a specialty needs to educate employers and work out ways to save money for them and, at the same time, maintain excellence in care for their employees. CSRO has a letter it used successfully with the human resources department of Edward Jones to effect a change in its policies on this matter, which you are welcome to use to craft your own to businesses.

Dr. Feldman is a rheumatologist in private practice with The Rheumatology Group in New Orleans. She is President of the CSRO, past chair of the Alliance for Safe Biologic Medicines, and a past member of the American College of Rheumatology insurance subcommittee. You can reach her at [email protected].

One-year-olds who received a parent-led intervention targeting early signs of autism spectrum disorder (ASD) had significantly reduced symptoms and chances of an autism diagnosis at age 3 years, in a new study.

These findings, which were published in JAMA Pediatrics, were the first evidence worldwide that a preemptive intervention during infancy could lead to such a significant improvement in children’s social development, resulting in “three times fewer diagnoses of autism at age 3,” said lead author Andrew Whitehouse, PhD, in a statement.

“No trial of a preemptive infant intervention, applied prior to diagnosis, has to date shown such an effect to impact diagnostic outcomes – until now,” he said.
 

Study intervention is a nontraditonal approach

Dr. Whitehouse, who is professor of Autism Research at Telethon Kids and University of Western Australia, and Director of CliniKids in Perth, said the intervention is a departure from traditional approaches. “Traditionally, therapy seeks to train children to learn ‘typical’ behaviors,” he said in an email. “The difference of this therapy is that we help parents understand the unique abilities of their baby, and to use these strengths as a foundation for future development.”

Dr. Whitehouse’s study included 103 children (aged approximately 12 months), who displayed at least three of five behaviors indicating a high likelihood of ASD as defined by the Social Attention and Communication Surveillance–Revised (SACS-R) 12-month checklist. The infants were randomized to receive either usual care or the intervention, which is called the iBASIS–Video Interaction to Promote Positive Parenting (iBASIS-VIPP). Usual care was delivered by community physicians, whereas the intervention involved 10 sessions delivered at home by a trained therapist.

“The iBASIS-VIPP uses video-feedback as a means of helping parents recognize their baby’s communication cues so they can respond in a way that builds their social communication development,” Dr. Whitehouse explained in an interview. “The therapist then provides guidance to the parent as to how their baby is communicating with them, and they can communicate back to have back-and-forth conversations.”

“We know these back-and-forth conversations are crucial to support early social communication development, and are a precursor to more complex skills, such as verbal language,” he added.

Reassessment of the children at age 3 years showed a “small but enduring” benefit of the intervention, noted the authors. Children in the intervention group had a reduction in ASD symptom severity (P = .04), and reduced odds of ASD classification, compared with children receiving usual care (6.7% vs. 20.5%; odds ratio, 0.18; P = .02).

The findings provide “initial evidence of efficacy for a new clinical model that uses a specific developmentally focused intervention,” noted the authors. “The children falling below the diagnostic threshold still had developmental difficulties, but by working with each child’s unique differences, rather than trying to counter them, the therapy has effectively supported their development through the early childhood years,” noted Dr. Whitehouse in a statement.
 

Other research has shown benefits of new study approach

This is a “solid” study, “but, as acknowledged by the authors, the main effects are small in magnitude, and longer-term outcomes will be important to capture,” said Jessica Brian, PhD, C Psych, associate professor in the department of pediatrics at the University of Toronto, colead at the Autism Research Centre, and psychologist and clinician-investigator at Holland Bloorview Kids Rehab Hospital in Toronto.

Dr. Brian said she and her coauthors of a paper published in Autism Research and others have shown that the kind of approach used in the new study can be helpful for enhancing different areas of toddler development, but “the specific finding of reduced likelihood of a clinical ASD diagnosis is a bit different.”

The goal of reducing the likelihood of an ASD diagnosis “needs to be considered carefully, from the perspective of autism acceptance,” she added. “From an acceptance lens, the primary objective of early intervention in ASD might be better positioned as aiming to enhance or support a young child’s development, help them make developmental progress, build on their strengths, optimize outcomes, or reduce impairment. … I think the authors do a good job of balancing this perspective.”
 

New study shows value of parent-mediated interventions

Overall, Dr. Brian, who coauthored the Canadian Paediatric Society’s position statement on ASD diagnosis, lauded the findings as good news.

“It shows the value of using parent-mediated interventions, which are far less costly and are more resource-efficient than most therapist-delivered models.”

“In cases where parent-mediated approaches are made available to families prior to diagnosis, there is potential for strong effects, when the brain is most amenable to learning. Such models may also be an ideal fit before diagnosis, since they are less resource-intensive than therapist-delivered models, which may only be funded by governments once a diagnosis is confirmed,” she said.

“Finally, parent-mediated programs have the potential to support parents during what, for many families, is a particularly challenging time as they identify their child’s developmental differences or receive a diagnosis. Such programs have potential to increase parents’ confidence in parenting a young child with unique learning needs.”

What Dr. Brian thought was missing from the paper was acknowledgment that, “despite early developmental gains from parent-mediated interventions, it is likely that most children with ASD will need additional supports throughout development.”

This study was sponsored by the Telethon Kids Institute. Dr. Whitehouse reported no conflicts of interest. Dr. Brian codeveloped a parent-mediated intervention for toddlers with probable or confirmed ASD (the Social ABCs), for which she does not receive any royalties.

One-year-olds who received a parent-led intervention targeting early signs of autism spectrum disorder (ASD) had significantly reduced symptoms and chances of an autism diagnosis at age 3 years, in a new study.

These findings, which were published in JAMA Pediatrics, were the first evidence worldwide that a preemptive intervention during infancy could lead to such a significant improvement in children’s social development, resulting in “three times fewer diagnoses of autism at age 3,” said lead author Andrew Whitehouse, PhD, in a statement.

“No trial of a preemptive infant intervention, applied prior to diagnosis, has to date shown such an effect to impact diagnostic outcomes – until now,” he said.
 

Study intervention is a nontraditonal approach

Dr. Whitehouse, who is professor of Autism Research at Telethon Kids and University of Western Australia, and Director of CliniKids in Perth, said the intervention is a departure from traditional approaches. “Traditionally, therapy seeks to train children to learn ‘typical’ behaviors,” he said in an email. “The difference of this therapy is that we help parents understand the unique abilities of their baby, and to use these strengths as a foundation for future development.”

Dr. Whitehouse’s study included 103 children (aged approximately 12 months), who displayed at least three of five behaviors indicating a high likelihood of ASD as defined by the Social Attention and Communication Surveillance–Revised (SACS-R) 12-month checklist. The infants were randomized to receive either usual care or the intervention, which is called the iBASIS–Video Interaction to Promote Positive Parenting (iBASIS-VIPP). Usual care was delivered by community physicians, whereas the intervention involved 10 sessions delivered at home by a trained therapist.

“The iBASIS-VIPP uses video-feedback as a means of helping parents recognize their baby’s communication cues so they can respond in a way that builds their social communication development,” Dr. Whitehouse explained in an interview. “The therapist then provides guidance to the parent as to how their baby is communicating with them, and they can communicate back to have back-and-forth conversations.”

“We know these back-and-forth conversations are crucial to support early social communication development, and are a precursor to more complex skills, such as verbal language,” he added.

Reassessment of the children at age 3 years showed a “small but enduring” benefit of the intervention, noted the authors. Children in the intervention group had a reduction in ASD symptom severity (P = .04), and reduced odds of ASD classification, compared with children receiving usual care (6.7% vs. 20.5%; odds ratio, 0.18; P = .02).

The findings provide “initial evidence of efficacy for a new clinical model that uses a specific developmentally focused intervention,” noted the authors. “The children falling below the diagnostic threshold still had developmental difficulties, but by working with each child’s unique differences, rather than trying to counter them, the therapy has effectively supported their development through the early childhood years,” noted Dr. Whitehouse in a statement.
 

Other research has shown benefits of new study approach

This is a “solid” study, “but, as acknowledged by the authors, the main effects are small in magnitude, and longer-term outcomes will be important to capture,” said Jessica Brian, PhD, C Psych, associate professor in the department of pediatrics at the University of Toronto, colead at the Autism Research Centre, and psychologist and clinician-investigator at Holland Bloorview Kids Rehab Hospital in Toronto.

Dr. Brian said she and her coauthors of a paper published in Autism Research and others have shown that the kind of approach used in the new study can be helpful for enhancing different areas of toddler development, but “the specific finding of reduced likelihood of a clinical ASD diagnosis is a bit different.”

The goal of reducing the likelihood of an ASD diagnosis “needs to be considered carefully, from the perspective of autism acceptance,” she added. “From an acceptance lens, the primary objective of early intervention in ASD might be better positioned as aiming to enhance or support a young child’s development, help them make developmental progress, build on their strengths, optimize outcomes, or reduce impairment. … I think the authors do a good job of balancing this perspective.”
 

New study shows value of parent-mediated interventions

Overall, Dr. Brian, who coauthored the Canadian Paediatric Society’s position statement on ASD diagnosis, lauded the findings as good news.

“It shows the value of using parent-mediated interventions, which are far less costly and are more resource-efficient than most therapist-delivered models.”

“In cases where parent-mediated approaches are made available to families prior to diagnosis, there is potential for strong effects, when the brain is most amenable to learning. Such models may also be an ideal fit before diagnosis, since they are less resource-intensive than therapist-delivered models, which may only be funded by governments once a diagnosis is confirmed,” she said.

“Finally, parent-mediated programs have the potential to support parents during what, for many families, is a particularly challenging time as they identify their child’s developmental differences or receive a diagnosis. Such programs have potential to increase parents’ confidence in parenting a young child with unique learning needs.”

What Dr. Brian thought was missing from the paper was acknowledgment that, “despite early developmental gains from parent-mediated interventions, it is likely that most children with ASD will need additional supports throughout development.”

This study was sponsored by the Telethon Kids Institute. Dr. Whitehouse reported no conflicts of interest. Dr. Brian codeveloped a parent-mediated intervention for toddlers with probable or confirmed ASD (the Social ABCs), for which she does not receive any royalties.

One-year-olds who received a parent-led intervention targeting early signs of autism spectrum disorder (ASD) had significantly reduced symptoms and chances of an autism diagnosis at age 3 years, in a new study.

These findings, which were published in JAMA Pediatrics, were the first evidence worldwide that a preemptive intervention during infancy could lead to such a significant improvement in children’s social development, resulting in “three times fewer diagnoses of autism at age 3,” said lead author Andrew Whitehouse, PhD, in a statement.

“No trial of a preemptive infant intervention, applied prior to diagnosis, has to date shown such an effect to impact diagnostic outcomes – until now,” he said.
 

Study intervention is a nontraditonal approach

Dr. Whitehouse, who is professor of Autism Research at Telethon Kids and University of Western Australia, and Director of CliniKids in Perth, said the intervention is a departure from traditional approaches. “Traditionally, therapy seeks to train children to learn ‘typical’ behaviors,” he said in an email. “The difference of this therapy is that we help parents understand the unique abilities of their baby, and to use these strengths as a foundation for future development.”

Dr. Whitehouse’s study included 103 children (aged approximately 12 months), who displayed at least three of five behaviors indicating a high likelihood of ASD as defined by the Social Attention and Communication Surveillance–Revised (SACS-R) 12-month checklist. The infants were randomized to receive either usual care or the intervention, which is called the iBASIS–Video Interaction to Promote Positive Parenting (iBASIS-VIPP). Usual care was delivered by community physicians, whereas the intervention involved 10 sessions delivered at home by a trained therapist.

“The iBASIS-VIPP uses video-feedback as a means of helping parents recognize their baby’s communication cues so they can respond in a way that builds their social communication development,” Dr. Whitehouse explained in an interview. “The therapist then provides guidance to the parent as to how their baby is communicating with them, and they can communicate back to have back-and-forth conversations.”

“We know these back-and-forth conversations are crucial to support early social communication development, and are a precursor to more complex skills, such as verbal language,” he added.

Reassessment of the children at age 3 years showed a “small but enduring” benefit of the intervention, noted the authors. Children in the intervention group had a reduction in ASD symptom severity (P = .04), and reduced odds of ASD classification, compared with children receiving usual care (6.7% vs. 20.5%; odds ratio, 0.18; P = .02).

The findings provide “initial evidence of efficacy for a new clinical model that uses a specific developmentally focused intervention,” noted the authors. “The children falling below the diagnostic threshold still had developmental difficulties, but by working with each child’s unique differences, rather than trying to counter them, the therapy has effectively supported their development through the early childhood years,” noted Dr. Whitehouse in a statement.
 

Other research has shown benefits of new study approach

This is a “solid” study, “but, as acknowledged by the authors, the main effects are small in magnitude, and longer-term outcomes will be important to capture,” said Jessica Brian, PhD, C Psych, associate professor in the department of pediatrics at the University of Toronto, colead at the Autism Research Centre, and psychologist and clinician-investigator at Holland Bloorview Kids Rehab Hospital in Toronto.

Dr. Brian said she and her coauthors of a paper published in Autism Research and others have shown that the kind of approach used in the new study can be helpful for enhancing different areas of toddler development, but “the specific finding of reduced likelihood of a clinical ASD diagnosis is a bit different.”

The goal of reducing the likelihood of an ASD diagnosis “needs to be considered carefully, from the perspective of autism acceptance,” she added. “From an acceptance lens, the primary objective of early intervention in ASD might be better positioned as aiming to enhance or support a young child’s development, help them make developmental progress, build on their strengths, optimize outcomes, or reduce impairment. … I think the authors do a good job of balancing this perspective.”
 

New study shows value of parent-mediated interventions

Overall, Dr. Brian, who coauthored the Canadian Paediatric Society’s position statement on ASD diagnosis, lauded the findings as good news.

“It shows the value of using parent-mediated interventions, which are far less costly and are more resource-efficient than most therapist-delivered models.”

“In cases where parent-mediated approaches are made available to families prior to diagnosis, there is potential for strong effects, when the brain is most amenable to learning. Such models may also be an ideal fit before diagnosis, since they are less resource-intensive than therapist-delivered models, which may only be funded by governments once a diagnosis is confirmed,” she said.

“Finally, parent-mediated programs have the potential to support parents during what, for many families, is a particularly challenging time as they identify their child’s developmental differences or receive a diagnosis. Such programs have potential to increase parents’ confidence in parenting a young child with unique learning needs.”

What Dr. Brian thought was missing from the paper was acknowledgment that, “despite early developmental gains from parent-mediated interventions, it is likely that most children with ASD will need additional supports throughout development.”

This study was sponsored by the Telethon Kids Institute. Dr. Whitehouse reported no conflicts of interest. Dr. Brian codeveloped a parent-mediated intervention for toddlers with probable or confirmed ASD (the Social ABCs), for which she does not receive any royalties.

Interleukin (IL)–23 inhibition may still have a role to play in the treatment of patients with axial spondyloarthritis (SpA), suggests research presented at the 12th International Congress on Spondyloarthritides.

There is a strong rationale for using IL-23 inhibitors in patients with axial SpA, and the IL-23/IL-17 axis has been proposed as a critical player in the pathophysiology of the disease. But around 2018 it became clear from randomized, controlled trials that IL-23 inhibition was ineffective at improving key clinical outcomes, at least in patients with axial disease.

Although the overall results of a systematic review and meta-analysis that was presented at the meeting corroborated the negative results seen with IL-23–inhibiting agents in clinical trials, there were some data showing benefits of the IL-23 inhibitor risankizumab on secondary outcomes in one trial.

To look at the available evidence, Louise Vanhoutte, a 2nd-year internal medicine student at University Hospitals Leuven (Belgium) worked under the guidance of Rik Lories, MD, PhD, head of the division of rheumatology at University Hospitals Leuven. Together they searched known databases for randomized, controlled trials investigating the use of IL-23 and IL-17 inhibitors for the treatment of adults with axial SpA or psoriatic arthritis. Studies could be either phase 2 or phase 3, but had to have included a placebo and used the ASAS40 (40% Improvement in Assessment of SpondyloArthritis International Society Response criteria), ASAS20, Bath Ankylosing Spondylitis Disease Activity Index, or SPARCC (Spondyloarthritis Research Consortium of Canada) index score to assess outcomes.

The systematic review whittled the number of clinical trials in the meta-analysis to 12, which concerned the use of ustekinumab, an IL-12/23 inhibitor, and risankizumab, along with two IL-17 inhibitors, ixekizumab and secukinumab. Data for the IL-23 inhibitors guselkumab and tildrakizumab were not available.

“To no surprise, Forest plots showed that there was a lack of efficacy for IL-23 agents in the treatment of axial spondyloarthritis and a superior efficacy for IL-17 inhibitors in the treatment of axial spondyloarthritis,” Ms. Vanhoutte reported.

The respective odds ratios for IL-23 and IL-17 inhibitors in getting patients to meet ASAS40 response criteria in comparison to baseline were 1.51 (95% confidence interval, 0.98-2.31) and 2.54 (95% CI, 2.02-3.19).

“Does this mean it is a dead-end street for all IL-23 inhibition?” she asked. Not necessarily. In the meta-analysis, not only did risankizumab lower the Ankylosing Spondylitis Disease Activity Score based on C-reactive protein (ASDAS-CRP) by a mean difference (MD) of –0.30 (95% CI, –0.41 to –0.19) from baseline values, but it also led to statistically significant reductions in SPARCC index score for the spine (MD, –3.10; 95% CI, –4.50 to –1.70) and high-sensitivity CRP (MD, –2.10; 95% CI, –2.56 to –1.64). The risankizumab findings might suggest there are potential disease-modifying properties for specifically targeting IL-23p19. There could also be a window of opportunity to use IL-23 inhibitors earlier.

“These are only results from one randomized, controlled trial in a small sample size where outcomes were reported as medians and interquartile ranges, so they had to be converted to means and standard deviations to have an odds ratio in the end,” she explained.

“Also, these were results from a radiographic axial spondyloarthritis population and not a nonradiographic axial spondyloarthritis population,” she added.

While that might limit the interpretation of the findings, “what we see here is both reduction in inflammation and reduction in structural disease progression as [measured] by SPARCC,” Ms. Vanhoutte said.

“Since IL-23 is an upstream molecule from IL-17 it’s probable that IL-23 is present in the prephase of the disease, in a prephase inflammation state,” she hypothesized. “This is especially interesting because there are very few randomized, controlled trials that examine therapeutic agents in nonradiographic axial spondyloarthritis,” she observed. Looking at IL-23 in radiographic, or established, disease therefore may not be as useful.

“I’m thinking you’re making actually a very important point for us,” commented Robert Landewé, MD, PhD, of Amsterdam University Medical Center.

“We are discussing whether or not IL-23 is important in inhibiting the disease activity of patients with axial spondyloarthritis, and we are surprised that it is not shown in RCTs.

“Why is it completely ineffective in axial spondyloarthritis? You show us that that is probably not the case,” Dr. Landewé suggested.

“What you make very clear here is that indeed there is some efficacy, and from a pathophysiological way of thinking it might be slightly different as compared with what most clinicians nowadays think.”

The study had no specific funding, and no disclosures were reported.

Interleukin (IL)–23 inhibition may still have a role to play in the treatment of patients with axial spondyloarthritis (SpA), suggests research presented at the 12th International Congress on Spondyloarthritides.

There is a strong rationale for using IL-23 inhibitors in patients with axial SpA, and the IL-23/IL-17 axis has been proposed as a critical player in the pathophysiology of the disease. But around 2018 it became clear from randomized, controlled trials that IL-23 inhibition was ineffective at improving key clinical outcomes, at least in patients with axial disease.

Although the overall results of a systematic review and meta-analysis that was presented at the meeting corroborated the negative results seen with IL-23–inhibiting agents in clinical trials, there were some data showing benefits of the IL-23 inhibitor risankizumab on secondary outcomes in one trial.

To look at the available evidence, Louise Vanhoutte, a 2nd-year internal medicine student at University Hospitals Leuven (Belgium) worked under the guidance of Rik Lories, MD, PhD, head of the division of rheumatology at University Hospitals Leuven. Together they searched known databases for randomized, controlled trials investigating the use of IL-23 and IL-17 inhibitors for the treatment of adults with axial SpA or psoriatic arthritis. Studies could be either phase 2 or phase 3, but had to have included a placebo and used the ASAS40 (40% Improvement in Assessment of SpondyloArthritis International Society Response criteria), ASAS20, Bath Ankylosing Spondylitis Disease Activity Index, or SPARCC (Spondyloarthritis Research Consortium of Canada) index score to assess outcomes.

The systematic review whittled the number of clinical trials in the meta-analysis to 12, which concerned the use of ustekinumab, an IL-12/23 inhibitor, and risankizumab, along with two IL-17 inhibitors, ixekizumab and secukinumab. Data for the IL-23 inhibitors guselkumab and tildrakizumab were not available.

“To no surprise, Forest plots showed that there was a lack of efficacy for IL-23 agents in the treatment of axial spondyloarthritis and a superior efficacy for IL-17 inhibitors in the treatment of axial spondyloarthritis,” Ms. Vanhoutte reported.

The respective odds ratios for IL-23 and IL-17 inhibitors in getting patients to meet ASAS40 response criteria in comparison to baseline were 1.51 (95% confidence interval, 0.98-2.31) and 2.54 (95% CI, 2.02-3.19).

“Does this mean it is a dead-end street for all IL-23 inhibition?” she asked. Not necessarily. In the meta-analysis, not only did risankizumab lower the Ankylosing Spondylitis Disease Activity Score based on C-reactive protein (ASDAS-CRP) by a mean difference (MD) of –0.30 (95% CI, –0.41 to –0.19) from baseline values, but it also led to statistically significant reductions in SPARCC index score for the spine (MD, –3.10; 95% CI, –4.50 to –1.70) and high-sensitivity CRP (MD, –2.10; 95% CI, –2.56 to –1.64). The risankizumab findings might suggest there are potential disease-modifying properties for specifically targeting IL-23p19. There could also be a window of opportunity to use IL-23 inhibitors earlier.

“These are only results from one randomized, controlled trial in a small sample size where outcomes were reported as medians and interquartile ranges, so they had to be converted to means and standard deviations to have an odds ratio in the end,” she explained.

“Also, these were results from a radiographic axial spondyloarthritis population and not a nonradiographic axial spondyloarthritis population,” she added.

While that might limit the interpretation of the findings, “what we see here is both reduction in inflammation and reduction in structural disease progression as [measured] by SPARCC,” Ms. Vanhoutte said.

“Since IL-23 is an upstream molecule from IL-17 it’s probable that IL-23 is present in the prephase of the disease, in a prephase inflammation state,” she hypothesized. “This is especially interesting because there are very few randomized, controlled trials that examine therapeutic agents in nonradiographic axial spondyloarthritis,” she observed. Looking at IL-23 in radiographic, or established, disease therefore may not be as useful.

“I’m thinking you’re making actually a very important point for us,” commented Robert Landewé, MD, PhD, of Amsterdam University Medical Center.

“We are discussing whether or not IL-23 is important in inhibiting the disease activity of patients with axial spondyloarthritis, and we are surprised that it is not shown in RCTs.

“Why is it completely ineffective in axial spondyloarthritis? You show us that that is probably not the case,” Dr. Landewé suggested.

“What you make very clear here is that indeed there is some efficacy, and from a pathophysiological way of thinking it might be slightly different as compared with what most clinicians nowadays think.”

The study had no specific funding, and no disclosures were reported.

Interleukin (IL)–23 inhibition may still have a role to play in the treatment of patients with axial spondyloarthritis (SpA), suggests research presented at the 12th International Congress on Spondyloarthritides.

There is a strong rationale for using IL-23 inhibitors in patients with axial SpA, and the IL-23/IL-17 axis has been proposed as a critical player in the pathophysiology of the disease. But around 2018 it became clear from randomized, controlled trials that IL-23 inhibition was ineffective at improving key clinical outcomes, at least in patients with axial disease.

Although the overall results of a systematic review and meta-analysis that was presented at the meeting corroborated the negative results seen with IL-23–inhibiting agents in clinical trials, there were some data showing benefits of the IL-23 inhibitor risankizumab on secondary outcomes in one trial.

To look at the available evidence, Louise Vanhoutte, a 2nd-year internal medicine student at University Hospitals Leuven (Belgium) worked under the guidance of Rik Lories, MD, PhD, head of the division of rheumatology at University Hospitals Leuven. Together they searched known databases for randomized, controlled trials investigating the use of IL-23 and IL-17 inhibitors for the treatment of adults with axial SpA or psoriatic arthritis. Studies could be either phase 2 or phase 3, but had to have included a placebo and used the ASAS40 (40% Improvement in Assessment of SpondyloArthritis International Society Response criteria), ASAS20, Bath Ankylosing Spondylitis Disease Activity Index, or SPARCC (Spondyloarthritis Research Consortium of Canada) index score to assess outcomes.

The systematic review whittled the number of clinical trials in the meta-analysis to 12, which concerned the use of ustekinumab, an IL-12/23 inhibitor, and risankizumab, along with two IL-17 inhibitors, ixekizumab and secukinumab. Data for the IL-23 inhibitors guselkumab and tildrakizumab were not available.

“To no surprise, Forest plots showed that there was a lack of efficacy for IL-23 agents in the treatment of axial spondyloarthritis and a superior efficacy for IL-17 inhibitors in the treatment of axial spondyloarthritis,” Ms. Vanhoutte reported.

The respective odds ratios for IL-23 and IL-17 inhibitors in getting patients to meet ASAS40 response criteria in comparison to baseline were 1.51 (95% confidence interval, 0.98-2.31) and 2.54 (95% CI, 2.02-3.19).

“Does this mean it is a dead-end street for all IL-23 inhibition?” she asked. Not necessarily. In the meta-analysis, not only did risankizumab lower the Ankylosing Spondylitis Disease Activity Score based on C-reactive protein (ASDAS-CRP) by a mean difference (MD) of –0.30 (95% CI, –0.41 to –0.19) from baseline values, but it also led to statistically significant reductions in SPARCC index score for the spine (MD, –3.10; 95% CI, –4.50 to –1.70) and high-sensitivity CRP (MD, –2.10; 95% CI, –2.56 to –1.64). The risankizumab findings might suggest there are potential disease-modifying properties for specifically targeting IL-23p19. There could also be a window of opportunity to use IL-23 inhibitors earlier.

“These are only results from one randomized, controlled trial in a small sample size where outcomes were reported as medians and interquartile ranges, so they had to be converted to means and standard deviations to have an odds ratio in the end,” she explained.

“Also, these were results from a radiographic axial spondyloarthritis population and not a nonradiographic axial spondyloarthritis population,” she added.

While that might limit the interpretation of the findings, “what we see here is both reduction in inflammation and reduction in structural disease progression as [measured] by SPARCC,” Ms. Vanhoutte said.

“Since IL-23 is an upstream molecule from IL-17 it’s probable that IL-23 is present in the prephase of the disease, in a prephase inflammation state,” she hypothesized. “This is especially interesting because there are very few randomized, controlled trials that examine therapeutic agents in nonradiographic axial spondyloarthritis,” she observed. Looking at IL-23 in radiographic, or established, disease therefore may not be as useful.

“I’m thinking you’re making actually a very important point for us,” commented Robert Landewé, MD, PhD, of Amsterdam University Medical Center.

“We are discussing whether or not IL-23 is important in inhibiting the disease activity of patients with axial spondyloarthritis, and we are surprised that it is not shown in RCTs.

“Why is it completely ineffective in axial spondyloarthritis? You show us that that is probably not the case,” Dr. Landewé suggested.

“What you make very clear here is that indeed there is some efficacy, and from a pathophysiological way of thinking it might be slightly different as compared with what most clinicians nowadays think.”

The study had no specific funding, and no disclosures were reported.

More than one-quarter of patients undergoing dermatologic surgery said they would prefer not to take an oral antibiotic, even if it could eliminate the risk of a surgical-site infection (SSI) and had negligible side effects, in a prospective multicenter study.

In addition, a similar proportion of patients preferred to take an antibiotic if there was no SSI reduction and a high risk of adverse events.

Those are two key findings from the study aimed at understanding patient preferences for prophylactic oral antibiotic use following dermatologic surgery, which was published in Dermatologic Surgery.

“Patient risk-benefit thresholds for using antibiotics vary considerably,” the study’s corresponding author, Jeremy R. Etzkorn, MD, MS, of the department of dermatology at the Hospital of the University of Pennsylvania, Philadelphia, told this news organization. “Physicians should appreciate and consider the variation between patients before deciding to send in a prescription after skin surgery.”

To investigate patient preferences about taking antibiotics to prevent SSI relative to antibiotic efficacy and antibiotic-associated adverse drug reactions, Dr. Etzkorn and colleagues at six U.S. medical centers prospectively administered a web-based survey and discrete choice experiment to 388 adults including dermatologic surgery patients and their family members, as well as health care workers (defined as dermatologic surgery patients who work in health care, individuals who work in health care and are accompanying patients to their surgery, or staff in the dermatology clinic.) “A lot has been published about physician preferences and practice patterns with respect to antibiotic prescribing after dermatologic surgery,” Dr. Etzkorn noted. “This is the first study to evaluate patient preferences in a rigorous way.”

He and his coinvestigators used a technique from marketing and product research (conjoint analysis/discrete choice experiments) to quantify what patients think about using antibiotics and what trade-offs they are – or are not – willing to make to reduce their risk of infection.

Nearly half of the respondents (47%) were patients, 29% were family members of patients, 19% were health care workers, and the rest were described as patient caregivers or “other.” More than half (59%) were female, the mean age at surgery was 59 years, and 69% had college or postgraduate degrees.

More than half of respondents (55%) would choose to take an antibiotic if it reduced the SSI rate from 5% to 2.5% and if the risk of adverse drug reactions was low (defined as a 1% risk gastrointestinal upset, 0.5% risk itchy skin rash, and 0.01% risk ED visit). Even if an antibiotic could eliminate SSI risk entirely and had a low adverse drug reaction profile, 27% of respondents preferred not to take prophylactic oral antibiotics.

A subgroup analysis revealed that only 21% of health care workers would choose a moderate efficacy antibiotic (2.5% SSI risk) with a high adverse effect profile, compared with 41% of those who do not work in health care. Respondent age also drove treatment choice. For example, only 33% of respondents younger than age 65 would choose a moderate efficacy antibiotic (2.5% SSI risk) with a high adverse effect profile, compared with 45% of those aged 65 years and older.

“We knew patients would likely trade some antibiotic efficacy for some side effects, just as one would trade price for features when shopping for a car,” Dr. Etzkorn said. “We were shocked to see that over a quarter – 27% – of respondents preferred to not take antibiotics even if they were able to prevent all infections and had minimal side effects.”

“It’s interesting that between 27% [and] 55% of patients preferred no operative antibiotic prophylaxis despite a theoretical 100% cure rate for surgical-site infections,” said Lawrence J. Green, MD, clinical professor of dermatology at George Washington University, Washington, who was asked to comment on the study results.

“I think this mirrors dermatologist’s preferences, as a majority also prefer not to prescribe postoperative antibiotic therapy, unless operating in an area of or a patient with a high risk for infection. It would also be interesting to see if a less educated population would also have similar preferences.”

Dr. Etzkorn acknowledged certain limitations of the study, including that while it evaluated patient reported preferences, it did not include all possible risks and benefits, and “it does not measure actual patient behaviors.”

The researchers reported having no relevant financial disclosures. Dr. Etzkorn disclosed that he serves as a data safety monitoring board member for a clinical trial of Replimmune. Dr. Green disclosed that he is a speaker, consultant, or investigator for numerous pharmaceutical companies.

[email protected]

More than one-quarter of patients undergoing dermatologic surgery said they would prefer not to take an oral antibiotic, even if it could eliminate the risk of a surgical-site infection (SSI) and had negligible side effects, in a prospective multicenter study.

In addition, a similar proportion of patients preferred to take an antibiotic if there was no SSI reduction and a high risk of adverse events.

Those are two key findings from the study aimed at understanding patient preferences for prophylactic oral antibiotic use following dermatologic surgery, which was published in Dermatologic Surgery.

“Patient risk-benefit thresholds for using antibiotics vary considerably,” the study’s corresponding author, Jeremy R. Etzkorn, MD, MS, of the department of dermatology at the Hospital of the University of Pennsylvania, Philadelphia, told this news organization. “Physicians should appreciate and consider the variation between patients before deciding to send in a prescription after skin surgery.”

To investigate patient preferences about taking antibiotics to prevent SSI relative to antibiotic efficacy and antibiotic-associated adverse drug reactions, Dr. Etzkorn and colleagues at six U.S. medical centers prospectively administered a web-based survey and discrete choice experiment to 388 adults including dermatologic surgery patients and their family members, as well as health care workers (defined as dermatologic surgery patients who work in health care, individuals who work in health care and are accompanying patients to their surgery, or staff in the dermatology clinic.) “A lot has been published about physician preferences and practice patterns with respect to antibiotic prescribing after dermatologic surgery,” Dr. Etzkorn noted. “This is the first study to evaluate patient preferences in a rigorous way.”

He and his coinvestigators used a technique from marketing and product research (conjoint analysis/discrete choice experiments) to quantify what patients think about using antibiotics and what trade-offs they are – or are not – willing to make to reduce their risk of infection.

Nearly half of the respondents (47%) were patients, 29% were family members of patients, 19% were health care workers, and the rest were described as patient caregivers or “other.” More than half (59%) were female, the mean age at surgery was 59 years, and 69% had college or postgraduate degrees.

More than half of respondents (55%) would choose to take an antibiotic if it reduced the SSI rate from 5% to 2.5% and if the risk of adverse drug reactions was low (defined as a 1% risk gastrointestinal upset, 0.5% risk itchy skin rash, and 0.01% risk ED visit). Even if an antibiotic could eliminate SSI risk entirely and had a low adverse drug reaction profile, 27% of respondents preferred not to take prophylactic oral antibiotics.

A subgroup analysis revealed that only 21% of health care workers would choose a moderate efficacy antibiotic (2.5% SSI risk) with a high adverse effect profile, compared with 41% of those who do not work in health care. Respondent age also drove treatment choice. For example, only 33% of respondents younger than age 65 would choose a moderate efficacy antibiotic (2.5% SSI risk) with a high adverse effect profile, compared with 45% of those aged 65 years and older.

“We knew patients would likely trade some antibiotic efficacy for some side effects, just as one would trade price for features when shopping for a car,” Dr. Etzkorn said. “We were shocked to see that over a quarter – 27% – of respondents preferred to not take antibiotics even if they were able to prevent all infections and had minimal side effects.”

“It’s interesting that between 27% [and] 55% of patients preferred no operative antibiotic prophylaxis despite a theoretical 100% cure rate for surgical-site infections,” said Lawrence J. Green, MD, clinical professor of dermatology at George Washington University, Washington, who was asked to comment on the study results.

“I think this mirrors dermatologist’s preferences, as a majority also prefer not to prescribe postoperative antibiotic therapy, unless operating in an area of or a patient with a high risk for infection. It would also be interesting to see if a less educated population would also have similar preferences.”

Dr. Etzkorn acknowledged certain limitations of the study, including that while it evaluated patient reported preferences, it did not include all possible risks and benefits, and “it does not measure actual patient behaviors.”

The researchers reported having no relevant financial disclosures. Dr. Etzkorn disclosed that he serves as a data safety monitoring board member for a clinical trial of Replimmune. Dr. Green disclosed that he is a speaker, consultant, or investigator for numerous pharmaceutical companies.

[email protected]

More than one-quarter of patients undergoing dermatologic surgery said they would prefer not to take an oral antibiotic, even if it could eliminate the risk of a surgical-site infection (SSI) and had negligible side effects, in a prospective multicenter study.

In addition, a similar proportion of patients preferred to take an antibiotic if there was no SSI reduction and a high risk of adverse events.

Those are two key findings from the study aimed at understanding patient preferences for prophylactic oral antibiotic use following dermatologic surgery, which was published in Dermatologic Surgery.

“Patient risk-benefit thresholds for using antibiotics vary considerably,” the study’s corresponding author, Jeremy R. Etzkorn, MD, MS, of the department of dermatology at the Hospital of the University of Pennsylvania, Philadelphia, told this news organization. “Physicians should appreciate and consider the variation between patients before deciding to send in a prescription after skin surgery.”

To investigate patient preferences about taking antibiotics to prevent SSI relative to antibiotic efficacy and antibiotic-associated adverse drug reactions, Dr. Etzkorn and colleagues at six U.S. medical centers prospectively administered a web-based survey and discrete choice experiment to 388 adults including dermatologic surgery patients and their family members, as well as health care workers (defined as dermatologic surgery patients who work in health care, individuals who work in health care and are accompanying patients to their surgery, or staff in the dermatology clinic.) “A lot has been published about physician preferences and practice patterns with respect to antibiotic prescribing after dermatologic surgery,” Dr. Etzkorn noted. “This is the first study to evaluate patient preferences in a rigorous way.”

He and his coinvestigators used a technique from marketing and product research (conjoint analysis/discrete choice experiments) to quantify what patients think about using antibiotics and what trade-offs they are – or are not – willing to make to reduce their risk of infection.

Nearly half of the respondents (47%) were patients, 29% were family members of patients, 19% were health care workers, and the rest were described as patient caregivers or “other.” More than half (59%) were female, the mean age at surgery was 59 years, and 69% had college or postgraduate degrees.

More than half of respondents (55%) would choose to take an antibiotic if it reduced the SSI rate from 5% to 2.5% and if the risk of adverse drug reactions was low (defined as a 1% risk gastrointestinal upset, 0.5% risk itchy skin rash, and 0.01% risk ED visit). Even if an antibiotic could eliminate SSI risk entirely and had a low adverse drug reaction profile, 27% of respondents preferred not to take prophylactic oral antibiotics.

A subgroup analysis revealed that only 21% of health care workers would choose a moderate efficacy antibiotic (2.5% SSI risk) with a high adverse effect profile, compared with 41% of those who do not work in health care. Respondent age also drove treatment choice. For example, only 33% of respondents younger than age 65 would choose a moderate efficacy antibiotic (2.5% SSI risk) with a high adverse effect profile, compared with 45% of those aged 65 years and older.

“We knew patients would likely trade some antibiotic efficacy for some side effects, just as one would trade price for features when shopping for a car,” Dr. Etzkorn said. “We were shocked to see that over a quarter – 27% – of respondents preferred to not take antibiotics even if they were able to prevent all infections and had minimal side effects.”

“It’s interesting that between 27% [and] 55% of patients preferred no operative antibiotic prophylaxis despite a theoretical 100% cure rate for surgical-site infections,” said Lawrence J. Green, MD, clinical professor of dermatology at George Washington University, Washington, who was asked to comment on the study results.

“I think this mirrors dermatologist’s preferences, as a majority also prefer not to prescribe postoperative antibiotic therapy, unless operating in an area of or a patient with a high risk for infection. It would also be interesting to see if a less educated population would also have similar preferences.”

Dr. Etzkorn acknowledged certain limitations of the study, including that while it evaluated patient reported preferences, it did not include all possible risks and benefits, and “it does not measure actual patient behaviors.”

The researchers reported having no relevant financial disclosures. Dr. Etzkorn disclosed that he serves as a data safety monitoring board member for a clinical trial of Replimmune. Dr. Green disclosed that he is a speaker, consultant, or investigator for numerous pharmaceutical companies.

[email protected]

The European Medicines Agency’s Committee for Medicinal Products for Human Use recommended marketing authorization this week for two new adalimumab biosimilars, Hukyndra and Libmyris.

The biosimilars, both developed by STADA Arzneimittel AG, will be available as a 40-mg solution for injection in a pre-filled syringe and pre-filled pen and 80-mg solution for injection in a pre-filled syringe. Both biosimilars will have 15 indications:

• rheumatoid arthritis
• polyarticular juvenile idiopathic arthritis
• enthesitis-related arthritis
• ankylosing spondylitis
• axial spondyloarthritis without radiographic evidence of ankylosing spondylitis
• psoriatic arthritis
• chronic plaque psoriasis (adults and children)
• hidradenitis suppurativa
• Crohn’s disease (adults and children)
• ulcerative colitis (adults and children)
• uveitis (adults and children)

Data show that both Hukyndra and Libmyris are highly similar to the reference product Humira (adalimumab), a monoclonal antibody to tumor necrosis factor alpha, and have comparable quality, safety, and efficacy.

A version of this article first appeared on Medscape.com.

The European Medicines Agency’s Committee for Medicinal Products for Human Use recommended marketing authorization this week for two new adalimumab biosimilars, Hukyndra and Libmyris.

The biosimilars, both developed by STADA Arzneimittel AG, will be available as a 40-mg solution for injection in a pre-filled syringe and pre-filled pen and 80-mg solution for injection in a pre-filled syringe. Both biosimilars will have 15 indications:

• rheumatoid arthritis
• polyarticular juvenile idiopathic arthritis
• enthesitis-related arthritis
• ankylosing spondylitis
• axial spondyloarthritis without radiographic evidence of ankylosing spondylitis
• psoriatic arthritis
• chronic plaque psoriasis (adults and children)
• hidradenitis suppurativa
• Crohn’s disease (adults and children)
• ulcerative colitis (adults and children)
• uveitis (adults and children)

Data show that both Hukyndra and Libmyris are highly similar to the reference product Humira (adalimumab), a monoclonal antibody to tumor necrosis factor alpha, and have comparable quality, safety, and efficacy.

A version of this article first appeared on Medscape.com.

The European Medicines Agency’s Committee for Medicinal Products for Human Use recommended marketing authorization this week for two new adalimumab biosimilars, Hukyndra and Libmyris.

The biosimilars, both developed by STADA Arzneimittel AG, will be available as a 40-mg solution for injection in a pre-filled syringe and pre-filled pen and 80-mg solution for injection in a pre-filled syringe. Both biosimilars will have 15 indications:

• rheumatoid arthritis
• polyarticular juvenile idiopathic arthritis
• enthesitis-related arthritis
• ankylosing spondylitis
• axial spondyloarthritis without radiographic evidence of ankylosing spondylitis
• psoriatic arthritis
• chronic plaque psoriasis (adults and children)
• hidradenitis suppurativa
• Crohn’s disease (adults and children)
• ulcerative colitis (adults and children)
• uveitis (adults and children)

Data show that both Hukyndra and Libmyris are highly similar to the reference product Humira (adalimumab), a monoclonal antibody to tumor necrosis factor alpha, and have comparable quality, safety, and efficacy.

A version of this article first appeared on Medscape.com.

Older adults in the United States – particularly among Black and Latino/Hispanic populations – experienced worse access to health care for chronic conditions during the pandemic than older adults in 10 other wealthy countries, according to findings from The Commonwealth Fund’s 2021 International Health Policy Survey of Older Adults released today.

David Blumenthal, MD, president of The Commonwealth Fund, said during a press briefing that surveying the senior population in the United States is particularly insightful because it is the only group with the universal coverage of Medicare, which offers a more direct comparison with other countries’ universal health care coverage.

More than one-third (37%) of older U.S. adults with multiple chronic conditions reported pandemic-related disruptions in their care – higher than rates in Canada, the Netherlands, and U.K. In Germany, only 11% had canceled or postponed appointments.

The survey was conducted between March and June 2021 and included responses from 18,477 adults age 65 and older in Australia, Canada, France, Germany, the Netherlands, New Zealand, Norway, Sweden, Switzerland, and U.K., and U.S. adults age 60 and older.

Among older adults who need help with daily activities, those in the United States, Canada, U.K., and Australia were the most likely to say they did not receive needed services from professionals or family members.

In the United States, 23% of people who said they needed help with activities such as housework, meal preparation, and medication management experienced a disruption in care because services were canceled or very limited during the pandemic. For comparison, only 8% of seniors in Germany and 11% of seniors in the Netherlands did not receive help with basic daily activities.
 

Many U.S. seniors used up savings

“Nearly one in five older adults report that they used up their savings or lost their main source of income because of the pandemic. We see much lower rates in other countries like Germany, Switzerland, the Netherlands, and Sweden,” Reginald D. Williams, vice president for international health policy and practice innovations at The Commonwealth Fund, said during a briefing.

Older U.S. adults reported economic difficulties related to the pandemic at a rate of up to six times that of other countries, he said.

The differences by race were stark. While 19% of U.S. seniors overall experienced financial hardships related to the pandemic, 32% of Black seniors and 39% of Latino/Hispanic seniors in the United States experienced hardships. Germany had the lowest rate, at 3% overall.

“As the COVID-19 pandemic in the United States continues to evolve,” Mr. Williams said, “finding ways to reduce care barriers – affordability and connecting adults to usual sources of primary care, enhancing access to economic supports and social services – can help narrow the gaps.”

Dr. Blumenthal said that even though “Medicare is a critical lifeline,” it has flaws.

“Medicare plans have significant gaps that leave beneficiaries vulnerable to sizable out-of-pocket expenses,” he said.

Placing caps on out-of-pocket costs and covering more health services, such as dental, vision, and hearing care, could help make the population less vulnerable, Dr. Blumenthal said. “The chronic lack of security facing U.S. seniors, especially those who are Black or Hispanic, is exacerbating the pandemic’s devastating toll,” he added.

Dr. Blumenthal and Mr. Williams have reported no relevant financial relationships.

A version of this article first appeared on Medscape.com.

Older adults in the United States – particularly among Black and Latino/Hispanic populations – experienced worse access to health care for chronic conditions during the pandemic than older adults in 10 other wealthy countries, according to findings from The Commonwealth Fund’s 2021 International Health Policy Survey of Older Adults released today.

David Blumenthal, MD, president of The Commonwealth Fund, said during a press briefing that surveying the senior population in the United States is particularly insightful because it is the only group with the universal coverage of Medicare, which offers a more direct comparison with other countries’ universal health care coverage.

More than one-third (37%) of older U.S. adults with multiple chronic conditions reported pandemic-related disruptions in their care – higher than rates in Canada, the Netherlands, and U.K. In Germany, only 11% had canceled or postponed appointments.

The survey was conducted between March and June 2021 and included responses from 18,477 adults age 65 and older in Australia, Canada, France, Germany, the Netherlands, New Zealand, Norway, Sweden, Switzerland, and U.K., and U.S. adults age 60 and older.

Among older adults who need help with daily activities, those in the United States, Canada, U.K., and Australia were the most likely to say they did not receive needed services from professionals or family members.

In the United States, 23% of people who said they needed help with activities such as housework, meal preparation, and medication management experienced a disruption in care because services were canceled or very limited during the pandemic. For comparison, only 8% of seniors in Germany and 11% of seniors in the Netherlands did not receive help with basic daily activities.
 

Many U.S. seniors used up savings

“Nearly one in five older adults report that they used up their savings or lost their main source of income because of the pandemic. We see much lower rates in other countries like Germany, Switzerland, the Netherlands, and Sweden,” Reginald D. Williams, vice president for international health policy and practice innovations at The Commonwealth Fund, said during a briefing.

Older U.S. adults reported economic difficulties related to the pandemic at a rate of up to six times that of other countries, he said.

The differences by race were stark. While 19% of U.S. seniors overall experienced financial hardships related to the pandemic, 32% of Black seniors and 39% of Latino/Hispanic seniors in the United States experienced hardships. Germany had the lowest rate, at 3% overall.

“As the COVID-19 pandemic in the United States continues to evolve,” Mr. Williams said, “finding ways to reduce care barriers – affordability and connecting adults to usual sources of primary care, enhancing access to economic supports and social services – can help narrow the gaps.”

Dr. Blumenthal said that even though “Medicare is a critical lifeline,” it has flaws.

“Medicare plans have significant gaps that leave beneficiaries vulnerable to sizable out-of-pocket expenses,” he said.

Placing caps on out-of-pocket costs and covering more health services, such as dental, vision, and hearing care, could help make the population less vulnerable, Dr. Blumenthal said. “The chronic lack of security facing U.S. seniors, especially those who are Black or Hispanic, is exacerbating the pandemic’s devastating toll,” he added.

Dr. Blumenthal and Mr. Williams have reported no relevant financial relationships.

A version of this article first appeared on Medscape.com.

Older adults in the United States – particularly among Black and Latino/Hispanic populations – experienced worse access to health care for chronic conditions during the pandemic than older adults in 10 other wealthy countries, according to findings from The Commonwealth Fund’s 2021 International Health Policy Survey of Older Adults released today.

David Blumenthal, MD, president of The Commonwealth Fund, said during a press briefing that surveying the senior population in the United States is particularly insightful because it is the only group with the universal coverage of Medicare, which offers a more direct comparison with other countries’ universal health care coverage.

More than one-third (37%) of older U.S. adults with multiple chronic conditions reported pandemic-related disruptions in their care – higher than rates in Canada, the Netherlands, and U.K. In Germany, only 11% had canceled or postponed appointments.

The survey was conducted between March and June 2021 and included responses from 18,477 adults age 65 and older in Australia, Canada, France, Germany, the Netherlands, New Zealand, Norway, Sweden, Switzerland, and U.K., and U.S. adults age 60 and older.

Among older adults who need help with daily activities, those in the United States, Canada, U.K., and Australia were the most likely to say they did not receive needed services from professionals or family members.

In the United States, 23% of people who said they needed help with activities such as housework, meal preparation, and medication management experienced a disruption in care because services were canceled or very limited during the pandemic. For comparison, only 8% of seniors in Germany and 11% of seniors in the Netherlands did not receive help with basic daily activities.
 

Many U.S. seniors used up savings

“Nearly one in five older adults report that they used up their savings or lost their main source of income because of the pandemic. We see much lower rates in other countries like Germany, Switzerland, the Netherlands, and Sweden,” Reginald D. Williams, vice president for international health policy and practice innovations at The Commonwealth Fund, said during a briefing.

Older U.S. adults reported economic difficulties related to the pandemic at a rate of up to six times that of other countries, he said.

The differences by race were stark. While 19% of U.S. seniors overall experienced financial hardships related to the pandemic, 32% of Black seniors and 39% of Latino/Hispanic seniors in the United States experienced hardships. Germany had the lowest rate, at 3% overall.

“As the COVID-19 pandemic in the United States continues to evolve,” Mr. Williams said, “finding ways to reduce care barriers – affordability and connecting adults to usual sources of primary care, enhancing access to economic supports and social services – can help narrow the gaps.”

Dr. Blumenthal said that even though “Medicare is a critical lifeline,” it has flaws.

“Medicare plans have significant gaps that leave beneficiaries vulnerable to sizable out-of-pocket expenses,” he said.

Placing caps on out-of-pocket costs and covering more health services, such as dental, vision, and hearing care, could help make the population less vulnerable, Dr. Blumenthal said. “The chronic lack of security facing U.S. seniors, especially those who are Black or Hispanic, is exacerbating the pandemic’s devastating toll,” he added.

Dr. Blumenthal and Mr. Williams have reported no relevant financial relationships.

A version of this article first appeared on Medscape.com.

Among Asian-Pacific populations, the first-degree relatives (FDRs) of individuals with inflammatory bowel disease (IBD) have a significantly increased risk for IBD themselves, according to a large analysis of data from South Korea. The greatest risk was found in siblings and for Crohn’s disease (CD).

The analysis of the South Korean Health Insurance Database included a cohort of 21,940,795 individuals from about 12 million families, with data collected between 2002 and 2017.

Previous studies have examined risk of IBD and familial relationships with existing IBD patients, but they have been subject to biases and have been heterogeneous in design, according to the authors, led by co–first authors Hyun Jung Kim, MD, of Korea University in Seoul, South Korea, and Shailja C. Shah, MD, of Vanderbilt University in Nashville, Tenn. There are few true population-based studies that quantify specific risks for family members of IBD patients, and none that were conducted in non-Western populations.

There are concerns about extrapolating familial IBD risk estimates from Western European populations to Asian populations because new data suggest that there are both genetic and nongenetic disease risk factors that reflect geography and ethnicity, the authors noted.

The researchers identified 45,717 individuals with ulcerative colitis (UC) and 17,848 with CD. Mean annual incidence rates were 4.6 cases of UC and 3.2 cases of CD per 100,000 person-years, which was relatively stable across the study period.

In all, 3.8% of UC and 3.1% of CD diagnoses occurred in FDR’s of existing patients. Among those with an FDR with IBD, the incidence of UC and CD was 54.5 and 99.2 per 100,000 person-years, respectively. When compared with individuals who had no FDRs with IBD, subjects who had an FDR with CD were at a more than 20-fold increased risk of CD (incident rate ratio, 22.2; 95% confidence interval, 20.5-24.5), whereas individuals with an FDR with UC were at a little more than a 10-fold risk for UC (IRR, 10.2; 95% CI, 9.39-11.1).

Subjects with an FDR with CD were at higher risk of UC (IRR, 3.56; 95% CI, 2.77-4.50), and those with an FDR with UC were at higher risk of CD (IRR, 2.94; 95% CI, 2.45-3.49). After adjustment for smoking, having an FDR with IBD was associated with an almost eightfold increased risk of UC (IRR, 7.94; 95% CI, 6.98-9.03) and a nearly 20-fold increased risk of CD (IRR, 19.03; 95% CI, 15.58-23.25).

The investigators also performed an analysis based on type of relative, with matching relations with unaffected relatives as the reference for each comparison. The highest risk for incident CD was with twin siblings (IRR, 336.2; 95% CI, 235.0-481.1) followed by nontwin siblings (IRR, 27.6; 95% CI, 24.6-30.9). The risk of CD among offspring of an affected father was 9.40 (95% CI, 6.81-13.0) and 6.54 (95% CI, 4.17-10.3) for offspring of affected mothers. There was a similar pattern for UC, although the magnitude was smaller: 163.7 for twin siblings (95% CI, 105.6-253.9), 13.1 for nontwin siblings (95% CI, 11.4-15.0), 7.11 for offspring of affected fathers (95% CI, 6.10-8.29), and 8.77 for offspring of affected mothers (95% CI, 7.46-10.3).

The researchers found no evidence of a birth cohort effect. Family history and IBD risk is a complicated relationship. Family history includes shared genetics as well as similar environmental exposures, and gene-environment interactions can add another layer of uncertainty. Previous studies have found that asymptomatic family members of IBD patients sometimes have preclinical signs such as changes in intestinal permeability, immune function, the microbiome, and biomarker levels.

IBD has emerged recently among Asian-Pacific populations as a serious health concern, with a recent rapid increase. This may reflect a shift in potentially modifiable environmental triggers. “Precisely quantifying familial risk and patterns might enable more accurate risk counseling and better-targeted clinical surveillance for earlier diagnosis and treatment among FDRs. Moreover, an accurate definition of familial IBD risk across populations also might inform subsequent investigations untangling the various shared environmental and genetic contributions,” the authors wrote.

Although genetic susceptibility is generally accepted as the predominant driver in familial trends for IBD, the authors noted their “study was not designed to determine the contribution of genetic vs. nongenetic determinants to familial IBD risk, and future well-designed dedicated investigations are needed to provide this clarity.”

The study is limited by the relatively short follow-up period, which may not have captured all IBD cases within patients’ families.

The authors have no relevant financial disclosures.

Among Asian-Pacific populations, the first-degree relatives (FDRs) of individuals with inflammatory bowel disease (IBD) have a significantly increased risk for IBD themselves, according to a large analysis of data from South Korea. The greatest risk was found in siblings and for Crohn’s disease (CD).

The analysis of the South Korean Health Insurance Database included a cohort of 21,940,795 individuals from about 12 million families, with data collected between 2002 and 2017.

Previous studies have examined risk of IBD and familial relationships with existing IBD patients, but they have been subject to biases and have been heterogeneous in design, according to the authors, led by co–first authors Hyun Jung Kim, MD, of Korea University in Seoul, South Korea, and Shailja C. Shah, MD, of Vanderbilt University in Nashville, Tenn. There are few true population-based studies that quantify specific risks for family members of IBD patients, and none that were conducted in non-Western populations.

There are concerns about extrapolating familial IBD risk estimates from Western European populations to Asian populations because new data suggest that there are both genetic and nongenetic disease risk factors that reflect geography and ethnicity, the authors noted.

The researchers identified 45,717 individuals with ulcerative colitis (UC) and 17,848 with CD. Mean annual incidence rates were 4.6 cases of UC and 3.2 cases of CD per 100,000 person-years, which was relatively stable across the study period.

In all, 3.8% of UC and 3.1% of CD diagnoses occurred in FDR’s of existing patients. Among those with an FDR with IBD, the incidence of UC and CD was 54.5 and 99.2 per 100,000 person-years, respectively. When compared with individuals who had no FDRs with IBD, subjects who had an FDR with CD were at a more than 20-fold increased risk of CD (incident rate ratio, 22.2; 95% confidence interval, 20.5-24.5), whereas individuals with an FDR with UC were at a little more than a 10-fold risk for UC (IRR, 10.2; 95% CI, 9.39-11.1).

Subjects with an FDR with CD were at higher risk of UC (IRR, 3.56; 95% CI, 2.77-4.50), and those with an FDR with UC were at higher risk of CD (IRR, 2.94; 95% CI, 2.45-3.49). After adjustment for smoking, having an FDR with IBD was associated with an almost eightfold increased risk of UC (IRR, 7.94; 95% CI, 6.98-9.03) and a nearly 20-fold increased risk of CD (IRR, 19.03; 95% CI, 15.58-23.25).

The investigators also performed an analysis based on type of relative, with matching relations with unaffected relatives as the reference for each comparison. The highest risk for incident CD was with twin siblings (IRR, 336.2; 95% CI, 235.0-481.1) followed by nontwin siblings (IRR, 27.6; 95% CI, 24.6-30.9). The risk of CD among offspring of an affected father was 9.40 (95% CI, 6.81-13.0) and 6.54 (95% CI, 4.17-10.3) for offspring of affected mothers. There was a similar pattern for UC, although the magnitude was smaller: 163.7 for twin siblings (95% CI, 105.6-253.9), 13.1 for nontwin siblings (95% CI, 11.4-15.0), 7.11 for offspring of affected fathers (95% CI, 6.10-8.29), and 8.77 for offspring of affected mothers (95% CI, 7.46-10.3).

The researchers found no evidence of a birth cohort effect. Family history and IBD risk is a complicated relationship. Family history includes shared genetics as well as similar environmental exposures, and gene-environment interactions can add another layer of uncertainty. Previous studies have found that asymptomatic family members of IBD patients sometimes have preclinical signs such as changes in intestinal permeability, immune function, the microbiome, and biomarker levels.

IBD has emerged recently among Asian-Pacific populations as a serious health concern, with a recent rapid increase. This may reflect a shift in potentially modifiable environmental triggers. “Precisely quantifying familial risk and patterns might enable more accurate risk counseling and better-targeted clinical surveillance for earlier diagnosis and treatment among FDRs. Moreover, an accurate definition of familial IBD risk across populations also might inform subsequent investigations untangling the various shared environmental and genetic contributions,” the authors wrote.

Although genetic susceptibility is generally accepted as the predominant driver in familial trends for IBD, the authors noted their “study was not designed to determine the contribution of genetic vs. nongenetic determinants to familial IBD risk, and future well-designed dedicated investigations are needed to provide this clarity.”

The study is limited by the relatively short follow-up period, which may not have captured all IBD cases within patients’ families.

The authors have no relevant financial disclosures.

Among Asian-Pacific populations, the first-degree relatives (FDRs) of individuals with inflammatory bowel disease (IBD) have a significantly increased risk for IBD themselves, according to a large analysis of data from South Korea. The greatest risk was found in siblings and for Crohn’s disease (CD).

The analysis of the South Korean Health Insurance Database included a cohort of 21,940,795 individuals from about 12 million families, with data collected between 2002 and 2017.

Previous studies have examined risk of IBD and familial relationships with existing IBD patients, but they have been subject to biases and have been heterogeneous in design, according to the authors, led by co–first authors Hyun Jung Kim, MD, of Korea University in Seoul, South Korea, and Shailja C. Shah, MD, of Vanderbilt University in Nashville, Tenn. There are few true population-based studies that quantify specific risks for family members of IBD patients, and none that were conducted in non-Western populations.

There are concerns about extrapolating familial IBD risk estimates from Western European populations to Asian populations because new data suggest that there are both genetic and nongenetic disease risk factors that reflect geography and ethnicity, the authors noted.

The researchers identified 45,717 individuals with ulcerative colitis (UC) and 17,848 with CD. Mean annual incidence rates were 4.6 cases of UC and 3.2 cases of CD per 100,000 person-years, which was relatively stable across the study period.

In all, 3.8% of UC and 3.1% of CD diagnoses occurred in FDR’s of existing patients. Among those with an FDR with IBD, the incidence of UC and CD was 54.5 and 99.2 per 100,000 person-years, respectively. When compared with individuals who had no FDRs with IBD, subjects who had an FDR with CD were at a more than 20-fold increased risk of CD (incident rate ratio, 22.2; 95% confidence interval, 20.5-24.5), whereas individuals with an FDR with UC were at a little more than a 10-fold risk for UC (IRR, 10.2; 95% CI, 9.39-11.1).

Subjects with an FDR with CD were at higher risk of UC (IRR, 3.56; 95% CI, 2.77-4.50), and those with an FDR with UC were at higher risk of CD (IRR, 2.94; 95% CI, 2.45-3.49). After adjustment for smoking, having an FDR with IBD was associated with an almost eightfold increased risk of UC (IRR, 7.94; 95% CI, 6.98-9.03) and a nearly 20-fold increased risk of CD (IRR, 19.03; 95% CI, 15.58-23.25).

The investigators also performed an analysis based on type of relative, with matching relations with unaffected relatives as the reference for each comparison. The highest risk for incident CD was with twin siblings (IRR, 336.2; 95% CI, 235.0-481.1) followed by nontwin siblings (IRR, 27.6; 95% CI, 24.6-30.9). The risk of CD among offspring of an affected father was 9.40 (95% CI, 6.81-13.0) and 6.54 (95% CI, 4.17-10.3) for offspring of affected mothers. There was a similar pattern for UC, although the magnitude was smaller: 163.7 for twin siblings (95% CI, 105.6-253.9), 13.1 for nontwin siblings (95% CI, 11.4-15.0), 7.11 for offspring of affected fathers (95% CI, 6.10-8.29), and 8.77 for offspring of affected mothers (95% CI, 7.46-10.3).

The researchers found no evidence of a birth cohort effect. Family history and IBD risk is a complicated relationship. Family history includes shared genetics as well as similar environmental exposures, and gene-environment interactions can add another layer of uncertainty. Previous studies have found that asymptomatic family members of IBD patients sometimes have preclinical signs such as changes in intestinal permeability, immune function, the microbiome, and biomarker levels.

IBD has emerged recently among Asian-Pacific populations as a serious health concern, with a recent rapid increase. This may reflect a shift in potentially modifiable environmental triggers. “Precisely quantifying familial risk and patterns might enable more accurate risk counseling and better-targeted clinical surveillance for earlier diagnosis and treatment among FDRs. Moreover, an accurate definition of familial IBD risk across populations also might inform subsequent investigations untangling the various shared environmental and genetic contributions,” the authors wrote.

Although genetic susceptibility is generally accepted as the predominant driver in familial trends for IBD, the authors noted their “study was not designed to determine the contribution of genetic vs. nongenetic determinants to familial IBD risk, and future well-designed dedicated investigations are needed to provide this clarity.”

The study is limited by the relatively short follow-up period, which may not have captured all IBD cases within patients’ families.

The authors have no relevant financial disclosures.

I once answered online skin questions. The most popular one was, “Is my penis supposed to look like that?”

Then the site was bought by an entrepreneur with a corporate sensibility. He opened two forums: for 15 bucks, you could access the Medical Forum and ask a doctor. For 10, you could join the Community Forum and ask anybody with an opinion. One guess about which forum was more popular.

Years later, a colleague referred a fellow who had run a poison ivy website for a decade and wanted to interview a doctor. He had never spoken with one before, “because it never occurred to me.” His site featured the usual folklore: that blister fluid spreads the poison, that you can catch it from your dog. His website had many pictures. Some were in focus, and a few actually showed poison ivy.

I checked a year later and found that he had never uploaded our interview to his website. When I emailed to ask how come, he said he’d been busy, and did I want him to? I told him I was OK.

What made me think of these old episodes was a phone chat I had the other day with an IT guy about my laptop.

After I told him my problem, he said, “Since you’re a doctor, could I ask you a medical question?”

“Sure.”

“Is the COVID vaccine safe?” he asked.

“I had two shots myself,” I said, “and I’m planning a third. Does that tell you what I think about how safe it is?”

He didn’t answer, and we got back to the laptop.

Five minutes later he said, “I just wonder whether we should mess with vaccines. Maybe we should let nature take its course.”

“How about polio and diphtheria?” I said. “Should we let nature take its course with them?”

He thought for a moment and said, “If you don’t get vaccinated, can you spread the virus to other people?”

“Yes, you can,” I said. “It’s not just that you can get sick, but you can make other people sick, and possibly die if they’re old or vulnerable.”

Again, no response. We finished up with the laptop.

“Thanks for your medical advice,” he said. “I get conflicting information from so many sources.”

Yes, he does. He and everybody else always have. When the issues are poison ivy and genital blotchiness, the stakes are not high enough for anyone to talk about. To a large extent, people have always made their minds up about things based on what their friends think and tell them.

If your friends all wear masks, they will stare at you if you don’t. If your friends don’t wear masks, they will stare at you if you do. Or more than that. Very few people like to be stared at. Or worse.

Dr. Rockoff, who wrote the Dermatology News column “Under My Skin,” is now retired, after more than 40 years of practice in Brookline, Mass. He served on the clinical faculty at Tufts University, Boston, and taught senior medical students and other trainees for 30 years. His latest book, “Doctoring from the Outside In,” was recently published. This is his last column for Dermatology News. Write to him at [email protected].

I once answered online skin questions. The most popular one was, “Is my penis supposed to look like that?”

Then the site was bought by an entrepreneur with a corporate sensibility. He opened two forums: for 15 bucks, you could access the Medical Forum and ask a doctor. For 10, you could join the Community Forum and ask anybody with an opinion. One guess about which forum was more popular.

Years later, a colleague referred a fellow who had run a poison ivy website for a decade and wanted to interview a doctor. He had never spoken with one before, “because it never occurred to me.” His site featured the usual folklore: that blister fluid spreads the poison, that you can catch it from your dog. His website had many pictures. Some were in focus, and a few actually showed poison ivy.

I checked a year later and found that he had never uploaded our interview to his website. When I emailed to ask how come, he said he’d been busy, and did I want him to? I told him I was OK.

What made me think of these old episodes was a phone chat I had the other day with an IT guy about my laptop.

After I told him my problem, he said, “Since you’re a doctor, could I ask you a medical question?”

“Sure.”

“Is the COVID vaccine safe?” he asked.

“I had two shots myself,” I said, “and I’m planning a third. Does that tell you what I think about how safe it is?”

He didn’t answer, and we got back to the laptop.

Five minutes later he said, “I just wonder whether we should mess with vaccines. Maybe we should let nature take its course.”

“How about polio and diphtheria?” I said. “Should we let nature take its course with them?”

He thought for a moment and said, “If you don’t get vaccinated, can you spread the virus to other people?”

“Yes, you can,” I said. “It’s not just that you can get sick, but you can make other people sick, and possibly die if they’re old or vulnerable.”

Again, no response. We finished up with the laptop.

“Thanks for your medical advice,” he said. “I get conflicting information from so many sources.”

Yes, he does. He and everybody else always have. When the issues are poison ivy and genital blotchiness, the stakes are not high enough for anyone to talk about. To a large extent, people have always made their minds up about things based on what their friends think and tell them.

If your friends all wear masks, they will stare at you if you don’t. If your friends don’t wear masks, they will stare at you if you do. Or more than that. Very few people like to be stared at. Or worse.

Dr. Rockoff, who wrote the Dermatology News column “Under My Skin,” is now retired, after more than 40 years of practice in Brookline, Mass. He served on the clinical faculty at Tufts University, Boston, and taught senior medical students and other trainees for 30 years. His latest book, “Doctoring from the Outside In,” was recently published. This is his last column for Dermatology News. Write to him at [email protected].

I once answered online skin questions. The most popular one was, “Is my penis supposed to look like that?”

Then the site was bought by an entrepreneur with a corporate sensibility. He opened two forums: for 15 bucks, you could access the Medical Forum and ask a doctor. For 10, you could join the Community Forum and ask anybody with an opinion. One guess about which forum was more popular.

Years later, a colleague referred a fellow who had run a poison ivy website for a decade and wanted to interview a doctor. He had never spoken with one before, “because it never occurred to me.” His site featured the usual folklore: that blister fluid spreads the poison, that you can catch it from your dog. His website had many pictures. Some were in focus, and a few actually showed poison ivy.

I checked a year later and found that he had never uploaded our interview to his website. When I emailed to ask how come, he said he’d been busy, and did I want him to? I told him I was OK.

What made me think of these old episodes was a phone chat I had the other day with an IT guy about my laptop.

After I told him my problem, he said, “Since you’re a doctor, could I ask you a medical question?”

“Sure.”

“Is the COVID vaccine safe?” he asked.

“I had two shots myself,” I said, “and I’m planning a third. Does that tell you what I think about how safe it is?”

He didn’t answer, and we got back to the laptop.

Five minutes later he said, “I just wonder whether we should mess with vaccines. Maybe we should let nature take its course.”

“How about polio and diphtheria?” I said. “Should we let nature take its course with them?”

He thought for a moment and said, “If you don’t get vaccinated, can you spread the virus to other people?”

“Yes, you can,” I said. “It’s not just that you can get sick, but you can make other people sick, and possibly die if they’re old or vulnerable.”

Again, no response. We finished up with the laptop.

“Thanks for your medical advice,” he said. “I get conflicting information from so many sources.”

Yes, he does. He and everybody else always have. When the issues are poison ivy and genital blotchiness, the stakes are not high enough for anyone to talk about. To a large extent, people have always made their minds up about things based on what their friends think and tell them.

If your friends all wear masks, they will stare at you if you don’t. If your friends don’t wear masks, they will stare at you if you do. Or more than that. Very few people like to be stared at. Or worse.

Dr. Rockoff, who wrote the Dermatology News column “Under My Skin,” is now retired, after more than 40 years of practice in Brookline, Mass. He served on the clinical faculty at Tufts University, Boston, and taught senior medical students and other trainees for 30 years. His latest book, “Doctoring from the Outside In,” was recently published. This is his last column for Dermatology News. Write to him at [email protected].