An agent biologically similar to the humanized monoclonal antibody natalizumab is as effective and safe as the original reference drug for relapsing remitting multiple sclerosis (RRMS) – and has a similar level of immunogenicity, new research shows.

The investigators noted that these phase 3 trial findings are the final stage in the regulatory approval process.

“There will be a biosimilar that with respect to all parameters – efficacy, side effects, immunogenicity – doesn’t differ from the original drug and will probably be an option to consider to reduce treatment costs in MS,” said lead investigator Bernhard Hemmer, MD, a professor in the department of neurology, Technical University of Munich (Germany).

The findings were published online in JAMA Neurology.
 

Potential cost savings

Disease-modifying therapies (DMTs), particularly targeted biologics, have revolutionized the treatment of MS, including RRMS. Natalizumab, which was the first targeted biologic therapy approved for RRMS, is very effective and widely used, Dr. Hemmer said.

However, this and other DMTs are costly. Biosimilars, which are medicines clinically similar to an already marketed reference biologic medicine, can address this issue. In the areas of rheumatology and oncology, biosimilars have already demonstrated significant cost savings and improved treatment access.

The biosimilar natalizumab (biosim-NTZ), developed by Polpharma Biologics, is the first biosimilar monoclonal antibody therapy to be developed for MS.

Health authorities such as the Food and Drug Administration require comparative phase 3 studies to confirm there are no clinically relevant differences between a proposed biosimilar and its reference medicine.

The new multicenter, phase 3, double-blind, randomized trial – known as Antelope – included 264 adult patients with RRMS at 48 centers in seven Eastern European countries. Most study participants were women (61.4%), and their mean age was 36.7 years.

All study participants were randomly assigned to receive intravenous infusions every 4 weeks of 300 mg of biosim-NTZ or reference natalizumab (ref-NTZ) for a total of 12 infusions.

At week 24, 30 patients were switched from ref-NTZ to biosim-NTZ for the remainder of their infusions. Including such a population is required by regulatory agencies to ensure switching patients from a drug they’ve been taking to a new biosimilar does not introduce any concerns, said Dr. Hemmer.
 

Comparable efficacy, safety profile

The primary efficacy endpoint was the cumulative number of new active brain lesions on MRI.

At baseline, 48.1% of the biosimilar group and 45.9% of the reference drug group had at least one gadolinium-enhancing lesion. In addition, 96.9% of the biosimilar group had more than 15 T2 lesions, compared with 96.2% of the reference group.

At week 24, the mean difference between biosim-NTZ and ref-NTZ in the cumulative number of new active lesions was 0.17 (least square means, 0.34 vs. 0.45), with a 95% confidence interval of –0.61 to 0.94 and a point estimate within the prespecified margins of ± 2.1.

The annualized relapse rate for biosim-NTZ and ref-NTZ was similar at 24 weeks (0.21 vs. 0.15), as well as at 48 weeks (0.17 vs. 0.13). For Expanded Disability Status Scale scores, which were similar between treatment groups at baseline (mean, 3.4 vs. 3.2), change at 24 and 48 weeks was minimal and similar in both groups.

The safety profile was as expected for patients with RRMS receiving natalizumab. There were few adverse events of special interest, with similar proportions across all treatment groups.

The overall adverse-event profile for patients who switched from ref-NTZ to biosim-NTZ was similar to patients continuing ref-NTZ treatment and did not indicate any new or increased risks associated with switching.

Rates of treatment-emergent adverse events (TEAEs) were similar, at 64.9% for biosim-NTZ, 68.9% for ref-NTZ, and 73.3% for the switch group. The most-reported TEAEs among all treatment groups were nervous system disorders and infections and infestations.

Progressive multifocal leukoencephalopathy (PML), a rare and potentially fatal demyelinating disease of the central nervous system, is associated with some DMTs – notably ref-NTZ. It is caused by infection with the John Cunningham virus (JCV) (also referred to as human polyomavirus), the researchers noted.

As per the study protocol, no participant had a JCV-positive index of more than 1.5 at baseline. Proportions of patients positive for anti-JCV antibodies were similarly distributed between treatment groups throughout the study.
 

Similar immunogenicity

There was strong concordance regarding positivity for treatment-emergent antidrug antibodies between the biosim-NTZ and ref-NTZ groups (79.4% and 74.0%). This was also the case for antinatalizumab-neutralizing antibodies (69.0% and 66.2%).

“There was nothing that indicated immunogenicity is different” between the two agents, said Dr. Hemmer.

While this might change “when you look at longer time periods,” antibodies to natalizumab usually develop “very early on,” he added.

Dr. Hemmer noted that this comparison of the proposed biosimilar with the reference drug had no real surprises.

“If the immunogenicity is the same, the mode of action is the same, and the dose is the same, you would expect to have a similar clinical effect and also a similar side-effect profile, which is indeed the case,” he said.

Dr. Hemmer added that he has no insight as to when the drug might be approved but believes developers expect that to occur sometime this year.
 

Welcome results

Commenting on the study results, Torge Rempe, MD, assistant professor in the department of neurology, University of Florida, Gainesville, and the William T. And Janice M. Neely professor for research in MS, said he welcomes these new results showing the biosimilar matched the reference medication.

“The authors report no significant difference in their primary endpoint of cumulative number of active lesions as well as their secondary clinical endpoints of annualized relapse rate and changes from baseline Expanded Disability Status Scale scores,” said Dr. Rempe, who was not involved with the research.

The study also showed the reported adverse events were similar between the biosimilar and reference natalizumab, he noted.

However, although no cases of PML were uncovered during the study period, further research is needed to determine long-term safety in this area, Dr. Rempe said.

Finally, he agreed that the development of biosimilars such as this one addresses the issue of high annual costs for DMTs, an area of concern in the field of MS.

The study was funded by Polpharma Biologics. Dr. Hemmer has reported receiving personal fees from Polpharma and Sandoz during the conduct of the study and personal fees from Novartis, Biocom, and TG Therapeutics outside the submitted work. He has also received a patent for genetic determinants of antibodies against interferon-beta and a patent for KIR4.1 antibodies in MS; served on scientific advisory boards for Novartis; served as a data monitoring and safety committee member for AllergyCare, Polpharma Biologics, Sandoz, and TG Therapeutics; and received speaker honoraria from Desitin, grants from Regeneron for MS research, and funding from the Multiple MS EU consortium, the CLINSPECT-M consortium, and the German Research Foundation. Dr. Rempe has reported no relevant financial relationships.

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

An agent biologically similar to the humanized monoclonal antibody natalizumab is as effective and safe as the original reference drug for relapsing remitting multiple sclerosis (RRMS) – and has a similar level of immunogenicity, new research shows.

The investigators noted that these phase 3 trial findings are the final stage in the regulatory approval process.

“There will be a biosimilar that with respect to all parameters – efficacy, side effects, immunogenicity – doesn’t differ from the original drug and will probably be an option to consider to reduce treatment costs in MS,” said lead investigator Bernhard Hemmer, MD, a professor in the department of neurology, Technical University of Munich (Germany).

The findings were published online in JAMA Neurology.
 

Potential cost savings

Disease-modifying therapies (DMTs), particularly targeted biologics, have revolutionized the treatment of MS, including RRMS. Natalizumab, which was the first targeted biologic therapy approved for RRMS, is very effective and widely used, Dr. Hemmer said.

However, this and other DMTs are costly. Biosimilars, which are medicines clinically similar to an already marketed reference biologic medicine, can address this issue. In the areas of rheumatology and oncology, biosimilars have already demonstrated significant cost savings and improved treatment access.

The biosimilar natalizumab (biosim-NTZ), developed by Polpharma Biologics, is the first biosimilar monoclonal antibody therapy to be developed for MS.

Health authorities such as the Food and Drug Administration require comparative phase 3 studies to confirm there are no clinically relevant differences between a proposed biosimilar and its reference medicine.

The new multicenter, phase 3, double-blind, randomized trial – known as Antelope – included 264 adult patients with RRMS at 48 centers in seven Eastern European countries. Most study participants were women (61.4%), and their mean age was 36.7 years.

All study participants were randomly assigned to receive intravenous infusions every 4 weeks of 300 mg of biosim-NTZ or reference natalizumab (ref-NTZ) for a total of 12 infusions.

At week 24, 30 patients were switched from ref-NTZ to biosim-NTZ for the remainder of their infusions. Including such a population is required by regulatory agencies to ensure switching patients from a drug they’ve been taking to a new biosimilar does not introduce any concerns, said Dr. Hemmer.
 

Comparable efficacy, safety profile

The primary efficacy endpoint was the cumulative number of new active brain lesions on MRI.

At baseline, 48.1% of the biosimilar group and 45.9% of the reference drug group had at least one gadolinium-enhancing lesion. In addition, 96.9% of the biosimilar group had more than 15 T2 lesions, compared with 96.2% of the reference group.

At week 24, the mean difference between biosim-NTZ and ref-NTZ in the cumulative number of new active lesions was 0.17 (least square means, 0.34 vs. 0.45), with a 95% confidence interval of –0.61 to 0.94 and a point estimate within the prespecified margins of ± 2.1.

The annualized relapse rate for biosim-NTZ and ref-NTZ was similar at 24 weeks (0.21 vs. 0.15), as well as at 48 weeks (0.17 vs. 0.13). For Expanded Disability Status Scale scores, which were similar between treatment groups at baseline (mean, 3.4 vs. 3.2), change at 24 and 48 weeks was minimal and similar in both groups.

The safety profile was as expected for patients with RRMS receiving natalizumab. There were few adverse events of special interest, with similar proportions across all treatment groups.

The overall adverse-event profile for patients who switched from ref-NTZ to biosim-NTZ was similar to patients continuing ref-NTZ treatment and did not indicate any new or increased risks associated with switching.

Rates of treatment-emergent adverse events (TEAEs) were similar, at 64.9% for biosim-NTZ, 68.9% for ref-NTZ, and 73.3% for the switch group. The most-reported TEAEs among all treatment groups were nervous system disorders and infections and infestations.

Progressive multifocal leukoencephalopathy (PML), a rare and potentially fatal demyelinating disease of the central nervous system, is associated with some DMTs – notably ref-NTZ. It is caused by infection with the John Cunningham virus (JCV) (also referred to as human polyomavirus), the researchers noted.

As per the study protocol, no participant had a JCV-positive index of more than 1.5 at baseline. Proportions of patients positive for anti-JCV antibodies were similarly distributed between treatment groups throughout the study.
 

Similar immunogenicity

There was strong concordance regarding positivity for treatment-emergent antidrug antibodies between the biosim-NTZ and ref-NTZ groups (79.4% and 74.0%). This was also the case for antinatalizumab-neutralizing antibodies (69.0% and 66.2%).

“There was nothing that indicated immunogenicity is different” between the two agents, said Dr. Hemmer.

While this might change “when you look at longer time periods,” antibodies to natalizumab usually develop “very early on,” he added.

Dr. Hemmer noted that this comparison of the proposed biosimilar with the reference drug had no real surprises.

“If the immunogenicity is the same, the mode of action is the same, and the dose is the same, you would expect to have a similar clinical effect and also a similar side-effect profile, which is indeed the case,” he said.

Dr. Hemmer added that he has no insight as to when the drug might be approved but believes developers expect that to occur sometime this year.
 

Welcome results

Commenting on the study results, Torge Rempe, MD, assistant professor in the department of neurology, University of Florida, Gainesville, and the William T. And Janice M. Neely professor for research in MS, said he welcomes these new results showing the biosimilar matched the reference medication.

“The authors report no significant difference in their primary endpoint of cumulative number of active lesions as well as their secondary clinical endpoints of annualized relapse rate and changes from baseline Expanded Disability Status Scale scores,” said Dr. Rempe, who was not involved with the research.

The study also showed the reported adverse events were similar between the biosimilar and reference natalizumab, he noted.

However, although no cases of PML were uncovered during the study period, further research is needed to determine long-term safety in this area, Dr. Rempe said.

Finally, he agreed that the development of biosimilars such as this one addresses the issue of high annual costs for DMTs, an area of concern in the field of MS.

The study was funded by Polpharma Biologics. Dr. Hemmer has reported receiving personal fees from Polpharma and Sandoz during the conduct of the study and personal fees from Novartis, Biocom, and TG Therapeutics outside the submitted work. He has also received a patent for genetic determinants of antibodies against interferon-beta and a patent for KIR4.1 antibodies in MS; served on scientific advisory boards for Novartis; served as a data monitoring and safety committee member for AllergyCare, Polpharma Biologics, Sandoz, and TG Therapeutics; and received speaker honoraria from Desitin, grants from Regeneron for MS research, and funding from the Multiple MS EU consortium, the CLINSPECT-M consortium, and the German Research Foundation. Dr. Rempe has reported no relevant financial relationships.

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

An agent biologically similar to the humanized monoclonal antibody natalizumab is as effective and safe as the original reference drug for relapsing remitting multiple sclerosis (RRMS) – and has a similar level of immunogenicity, new research shows.

The investigators noted that these phase 3 trial findings are the final stage in the regulatory approval process.

“There will be a biosimilar that with respect to all parameters – efficacy, side effects, immunogenicity – doesn’t differ from the original drug and will probably be an option to consider to reduce treatment costs in MS,” said lead investigator Bernhard Hemmer, MD, a professor in the department of neurology, Technical University of Munich (Germany).

The findings were published online in JAMA Neurology.
 

Potential cost savings

Disease-modifying therapies (DMTs), particularly targeted biologics, have revolutionized the treatment of MS, including RRMS. Natalizumab, which was the first targeted biologic therapy approved for RRMS, is very effective and widely used, Dr. Hemmer said.

However, this and other DMTs are costly. Biosimilars, which are medicines clinically similar to an already marketed reference biologic medicine, can address this issue. In the areas of rheumatology and oncology, biosimilars have already demonstrated significant cost savings and improved treatment access.

The biosimilar natalizumab (biosim-NTZ), developed by Polpharma Biologics, is the first biosimilar monoclonal antibody therapy to be developed for MS.

Health authorities such as the Food and Drug Administration require comparative phase 3 studies to confirm there are no clinically relevant differences between a proposed biosimilar and its reference medicine.

The new multicenter, phase 3, double-blind, randomized trial – known as Antelope – included 264 adult patients with RRMS at 48 centers in seven Eastern European countries. Most study participants were women (61.4%), and their mean age was 36.7 years.

All study participants were randomly assigned to receive intravenous infusions every 4 weeks of 300 mg of biosim-NTZ or reference natalizumab (ref-NTZ) for a total of 12 infusions.

At week 24, 30 patients were switched from ref-NTZ to biosim-NTZ for the remainder of their infusions. Including such a population is required by regulatory agencies to ensure switching patients from a drug they’ve been taking to a new biosimilar does not introduce any concerns, said Dr. Hemmer.
 

Comparable efficacy, safety profile

The primary efficacy endpoint was the cumulative number of new active brain lesions on MRI.

At baseline, 48.1% of the biosimilar group and 45.9% of the reference drug group had at least one gadolinium-enhancing lesion. In addition, 96.9% of the biosimilar group had more than 15 T2 lesions, compared with 96.2% of the reference group.

At week 24, the mean difference between biosim-NTZ and ref-NTZ in the cumulative number of new active lesions was 0.17 (least square means, 0.34 vs. 0.45), with a 95% confidence interval of –0.61 to 0.94 and a point estimate within the prespecified margins of ± 2.1.

The annualized relapse rate for biosim-NTZ and ref-NTZ was similar at 24 weeks (0.21 vs. 0.15), as well as at 48 weeks (0.17 vs. 0.13). For Expanded Disability Status Scale scores, which were similar between treatment groups at baseline (mean, 3.4 vs. 3.2), change at 24 and 48 weeks was minimal and similar in both groups.

The safety profile was as expected for patients with RRMS receiving natalizumab. There were few adverse events of special interest, with similar proportions across all treatment groups.

The overall adverse-event profile for patients who switched from ref-NTZ to biosim-NTZ was similar to patients continuing ref-NTZ treatment and did not indicate any new or increased risks associated with switching.

Rates of treatment-emergent adverse events (TEAEs) were similar, at 64.9% for biosim-NTZ, 68.9% for ref-NTZ, and 73.3% for the switch group. The most-reported TEAEs among all treatment groups were nervous system disorders and infections and infestations.

Progressive multifocal leukoencephalopathy (PML), a rare and potentially fatal demyelinating disease of the central nervous system, is associated with some DMTs – notably ref-NTZ. It is caused by infection with the John Cunningham virus (JCV) (also referred to as human polyomavirus), the researchers noted.

As per the study protocol, no participant had a JCV-positive index of more than 1.5 at baseline. Proportions of patients positive for anti-JCV antibodies were similarly distributed between treatment groups throughout the study.
 

Similar immunogenicity

There was strong concordance regarding positivity for treatment-emergent antidrug antibodies between the biosim-NTZ and ref-NTZ groups (79.4% and 74.0%). This was also the case for antinatalizumab-neutralizing antibodies (69.0% and 66.2%).

“There was nothing that indicated immunogenicity is different” between the two agents, said Dr. Hemmer.

While this might change “when you look at longer time periods,” antibodies to natalizumab usually develop “very early on,” he added.

Dr. Hemmer noted that this comparison of the proposed biosimilar with the reference drug had no real surprises.

“If the immunogenicity is the same, the mode of action is the same, and the dose is the same, you would expect to have a similar clinical effect and also a similar side-effect profile, which is indeed the case,” he said.

Dr. Hemmer added that he has no insight as to when the drug might be approved but believes developers expect that to occur sometime this year.
 

Welcome results

Commenting on the study results, Torge Rempe, MD, assistant professor in the department of neurology, University of Florida, Gainesville, and the William T. And Janice M. Neely professor for research in MS, said he welcomes these new results showing the biosimilar matched the reference medication.

“The authors report no significant difference in their primary endpoint of cumulative number of active lesions as well as their secondary clinical endpoints of annualized relapse rate and changes from baseline Expanded Disability Status Scale scores,” said Dr. Rempe, who was not involved with the research.

The study also showed the reported adverse events were similar between the biosimilar and reference natalizumab, he noted.

However, although no cases of PML were uncovered during the study period, further research is needed to determine long-term safety in this area, Dr. Rempe said.

Finally, he agreed that the development of biosimilars such as this one addresses the issue of high annual costs for DMTs, an area of concern in the field of MS.

The study was funded by Polpharma Biologics. Dr. Hemmer has reported receiving personal fees from Polpharma and Sandoz during the conduct of the study and personal fees from Novartis, Biocom, and TG Therapeutics outside the submitted work. He has also received a patent for genetic determinants of antibodies against interferon-beta and a patent for KIR4.1 antibodies in MS; served on scientific advisory boards for Novartis; served as a data monitoring and safety committee member for AllergyCare, Polpharma Biologics, Sandoz, and TG Therapeutics; and received speaker honoraria from Desitin, grants from Regeneron for MS research, and funding from the Multiple MS EU consortium, the CLINSPECT-M consortium, and the German Research Foundation. Dr. Rempe has reported no relevant financial relationships.

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

Dear friends,

Since the last issue of The New Gastroenterologist, the GI Fellowship Match has occurred and CONGRATULATIONS to the Class of 2026! You’ve all been on an arduous journey to get here, and it’s really time to slow down and soak up as much as you can. For those who did not match, do not give up, because you are still the future of GI!

This issue of TNG is particularly special to me, because it marks my first official selection of articles as I embark on my own TNG journey, and the theme is the future of GI. In the “In Focus” article this quarter, Dr. Eugenia N. Uche-Anya and Dr. Tyler M. Berzin review the vast and emerging advances of artificial intelligence (AI) in colonoscopy, its role in augmenting patient care, obstacles in incorporating AI into current practice, and the future of AI in gastroenterology and hepatology. One important aspect of developing our future in these technologies includes getting involved with industry. Dr. Raman Muthusamy gives practical tips on developing and navigating relationships with industry, with highlights on understanding intellectual property and conflicts of interest.

Continuing our trek into the future of GI, telemedicine came into the fold with the COVID-19 pandemic, and it is clearly here to stay. Dr. Russ R. Arjal repositions telemedicine as a way to increase access to care and optimize practice revenue, with the aim of improving patient outcomes in the future.

Last, to ground this issue clinically, Dr. Jason Kwon and Dr. Paul T. Kroner review the gastrointestinal, hepatic, and pancreaticobiliary adverse manifestations and management of immune checkpoint inhibitors, especially now that immunotherapies have revolutionized the treatment of cancer. As gastroenterologists, we are and will be seeing more and more of these adverse events.

If you are interested in contributing or have ideas for future TNG topics, please contact me ([email protected]). You may also contact Jillian Schweitzer ([email protected]), managing editor of TNG.

Until next time, I leave you with a historical fun fact: Philipp Bozzini is credited with having developed the first endoscope in 1805, called the Lichtleiter (German for “light conductor”), using a candle as its light source. Adolf Kussmaul, however, developed the first rigid gastroscope in 1868, recruiting a sword-swallower in his first demonstration.


Yours truly,

Judy A. Trieu, MD, MPH
Editor-in-Chief
Advanced Endoscopy Fellow
Division of Gastroenterology & Hepatology
University of North Carolina at Chapel Hill

Dear friends,

Since the last issue of The New Gastroenterologist, the GI Fellowship Match has occurred and CONGRATULATIONS to the Class of 2026! You’ve all been on an arduous journey to get here, and it’s really time to slow down and soak up as much as you can. For those who did not match, do not give up, because you are still the future of GI!

This issue of TNG is particularly special to me, because it marks my first official selection of articles as I embark on my own TNG journey, and the theme is the future of GI. In the “In Focus” article this quarter, Dr. Eugenia N. Uche-Anya and Dr. Tyler M. Berzin review the vast and emerging advances of artificial intelligence (AI) in colonoscopy, its role in augmenting patient care, obstacles in incorporating AI into current practice, and the future of AI in gastroenterology and hepatology. One important aspect of developing our future in these technologies includes getting involved with industry. Dr. Raman Muthusamy gives practical tips on developing and navigating relationships with industry, with highlights on understanding intellectual property and conflicts of interest.

Continuing our trek into the future of GI, telemedicine came into the fold with the COVID-19 pandemic, and it is clearly here to stay. Dr. Russ R. Arjal repositions telemedicine as a way to increase access to care and optimize practice revenue, with the aim of improving patient outcomes in the future.

Last, to ground this issue clinically, Dr. Jason Kwon and Dr. Paul T. Kroner review the gastrointestinal, hepatic, and pancreaticobiliary adverse manifestations and management of immune checkpoint inhibitors, especially now that immunotherapies have revolutionized the treatment of cancer. As gastroenterologists, we are and will be seeing more and more of these adverse events.

If you are interested in contributing or have ideas for future TNG topics, please contact me ([email protected]). You may also contact Jillian Schweitzer ([email protected]), managing editor of TNG.

Until next time, I leave you with a historical fun fact: Philipp Bozzini is credited with having developed the first endoscope in 1805, called the Lichtleiter (German for “light conductor”), using a candle as its light source. Adolf Kussmaul, however, developed the first rigid gastroscope in 1868, recruiting a sword-swallower in his first demonstration.


Yours truly,

Judy A. Trieu, MD, MPH
Editor-in-Chief
Advanced Endoscopy Fellow
Division of Gastroenterology & Hepatology
University of North Carolina at Chapel Hill

Dear friends,

Since the last issue of The New Gastroenterologist, the GI Fellowship Match has occurred and CONGRATULATIONS to the Class of 2026! You’ve all been on an arduous journey to get here, and it’s really time to slow down and soak up as much as you can. For those who did not match, do not give up, because you are still the future of GI!

This issue of TNG is particularly special to me, because it marks my first official selection of articles as I embark on my own TNG journey, and the theme is the future of GI. In the “In Focus” article this quarter, Dr. Eugenia N. Uche-Anya and Dr. Tyler M. Berzin review the vast and emerging advances of artificial intelligence (AI) in colonoscopy, its role in augmenting patient care, obstacles in incorporating AI into current practice, and the future of AI in gastroenterology and hepatology. One important aspect of developing our future in these technologies includes getting involved with industry. Dr. Raman Muthusamy gives practical tips on developing and navigating relationships with industry, with highlights on understanding intellectual property and conflicts of interest.

Continuing our trek into the future of GI, telemedicine came into the fold with the COVID-19 pandemic, and it is clearly here to stay. Dr. Russ R. Arjal repositions telemedicine as a way to increase access to care and optimize practice revenue, with the aim of improving patient outcomes in the future.

Last, to ground this issue clinically, Dr. Jason Kwon and Dr. Paul T. Kroner review the gastrointestinal, hepatic, and pancreaticobiliary adverse manifestations and management of immune checkpoint inhibitors, especially now that immunotherapies have revolutionized the treatment of cancer. As gastroenterologists, we are and will be seeing more and more of these adverse events.

If you are interested in contributing or have ideas for future TNG topics, please contact me ([email protected]). You may also contact Jillian Schweitzer ([email protected]), managing editor of TNG.

Until next time, I leave you with a historical fun fact: Philipp Bozzini is credited with having developed the first endoscope in 1805, called the Lichtleiter (German for “light conductor”), using a candle as its light source. Adolf Kussmaul, however, developed the first rigid gastroscope in 1868, recruiting a sword-swallower in his first demonstration.


Yours truly,

Judy A. Trieu, MD, MPH
Editor-in-Chief
Advanced Endoscopy Fellow
Division of Gastroenterology & Hepatology
University of North Carolina at Chapel Hill

Innovations in biomedical technology – from modern endoscopic devices and techniques to harnessing the microbiome to prevent and treat disease – have fundamentally changed the way in which we practice medicine and significantly improved the lives of our patients. In our February issue, we are pleased to highlight the launch of AGA’s GI Opportunity Fund, a new investment vehicle that provides AGA members and others a direct pathway to support development of promising, early-stage innovations by funding carefully vetted, cutting-edge start-up companies. We hope you will enjoy learning more about this exciting new initiative, which recently made its first major investment.

In our February Member Spotlight column, we feature Dr. Simon Mathews and his work to bring greater visibility to digital health technologies and their use in gastroenterology and beyond. I want to thank GIHN Associate Editor Dr. Janice Jou for agreeing to spearhead this new column as its section editor – again, we invite you to nominate your colleagues, mentees, and others to be featured in future Member Spotlight columns.

We also highlight several recent papers published in AGA’s flagship journals, including a study assessing clinical outcomes and adverse events in patients receiving oral vs. colonic fecal microbiota transplant (FMT) for recurrent C. difficile infection, and another evaluating the cost-effectiveness of earlier colorectal cancer screening in patients with obesity. On the policy front, we summarize GI-relevant portions of the $1.7 trillion FY 2023 Omnibus Appropriations bill, signed into law on Dec. 30, 2022, by President Biden, and assess its impact on Medicare payments, continuation of support for telehealth/virtual care, and NIH-funding. We hope you enjoy reading these and other articles presented in our February issue.
 

Don’t forget to register for DDW 2023, May 6-9, 2023, in Chicago – general registration is now open!

Megan A. Adams, MD, JD, MSc
Editor-in-Chief

Innovations in biomedical technology – from modern endoscopic devices and techniques to harnessing the microbiome to prevent and treat disease – have fundamentally changed the way in which we practice medicine and significantly improved the lives of our patients. In our February issue, we are pleased to highlight the launch of AGA’s GI Opportunity Fund, a new investment vehicle that provides AGA members and others a direct pathway to support development of promising, early-stage innovations by funding carefully vetted, cutting-edge start-up companies. We hope you will enjoy learning more about this exciting new initiative, which recently made its first major investment.

In our February Member Spotlight column, we feature Dr. Simon Mathews and his work to bring greater visibility to digital health technologies and their use in gastroenterology and beyond. I want to thank GIHN Associate Editor Dr. Janice Jou for agreeing to spearhead this new column as its section editor – again, we invite you to nominate your colleagues, mentees, and others to be featured in future Member Spotlight columns.

We also highlight several recent papers published in AGA’s flagship journals, including a study assessing clinical outcomes and adverse events in patients receiving oral vs. colonic fecal microbiota transplant (FMT) for recurrent C. difficile infection, and another evaluating the cost-effectiveness of earlier colorectal cancer screening in patients with obesity. On the policy front, we summarize GI-relevant portions of the $1.7 trillion FY 2023 Omnibus Appropriations bill, signed into law on Dec. 30, 2022, by President Biden, and assess its impact on Medicare payments, continuation of support for telehealth/virtual care, and NIH-funding. We hope you enjoy reading these and other articles presented in our February issue.
 

Don’t forget to register for DDW 2023, May 6-9, 2023, in Chicago – general registration is now open!

Megan A. Adams, MD, JD, MSc
Editor-in-Chief

Innovations in biomedical technology – from modern endoscopic devices and techniques to harnessing the microbiome to prevent and treat disease – have fundamentally changed the way in which we practice medicine and significantly improved the lives of our patients. In our February issue, we are pleased to highlight the launch of AGA’s GI Opportunity Fund, a new investment vehicle that provides AGA members and others a direct pathway to support development of promising, early-stage innovations by funding carefully vetted, cutting-edge start-up companies. We hope you will enjoy learning more about this exciting new initiative, which recently made its first major investment.

In our February Member Spotlight column, we feature Dr. Simon Mathews and his work to bring greater visibility to digital health technologies and their use in gastroenterology and beyond. I want to thank GIHN Associate Editor Dr. Janice Jou for agreeing to spearhead this new column as its section editor – again, we invite you to nominate your colleagues, mentees, and others to be featured in future Member Spotlight columns.

We also highlight several recent papers published in AGA’s flagship journals, including a study assessing clinical outcomes and adverse events in patients receiving oral vs. colonic fecal microbiota transplant (FMT) for recurrent C. difficile infection, and another evaluating the cost-effectiveness of earlier colorectal cancer screening in patients with obesity. On the policy front, we summarize GI-relevant portions of the $1.7 trillion FY 2023 Omnibus Appropriations bill, signed into law on Dec. 30, 2022, by President Biden, and assess its impact on Medicare payments, continuation of support for telehealth/virtual care, and NIH-funding. We hope you enjoy reading these and other articles presented in our February issue.
 

Don’t forget to register for DDW 2023, May 6-9, 2023, in Chicago – general registration is now open!

Megan A. Adams, MD, JD, MSc
Editor-in-Chief

Gastroenterologist Simon C. Mathews, MD, sees himself as a disciple of patient safety and quality improvement.

“It’s influenced the way I see medicine and the work that I do around identifying quality, not in the conventional context in a hospital or a clinic, but applying that lens to the world of technology,” said Dr. Mathews, assistant professor of medicine at Johns Hopkins Medicine in Baltimore.

Bringing greater visibility to digital health technologies is part of his life’s work.

“There is now an expectation that high quality must be part of the development process of these new technologies,” said Dr. Mathews.

In particular, he’d like to see noninvasive diagnostic technologies in the gastroenterology world become more patient-centric.

Bringing somebody into the hospital is often inconvenient and disruptive. The field is heading toward technologies that can be used in the home or in an outpatient setting. “I have some research in that area, and I’d love to see it ultimately reach the patient at the bedside, if possible.”

Dr. Mathews is a member of the AGA Center for GI Innovation and Technology and a previous mentee in the Future Leaders Program.

In an interview, Dr. Mathews discussed his push to validate health technologies in the GI field and to make them more transparent to physicians and patients.

Question: Why did you choose GI? 

Answer: I think the world of gastroenterology offers a tremendous amount of diversity in the way we manage and treat patients. There’s a huge spectrum of disease. There’s also the procedural aspect, which is very different from a lot of other medical specialties. For me particularly, there’s the opportunity to work on technology as it relates to GI, as well as research in that space.

Q: It seems like gastroenterology involves a lot of detective work. Would you say that’s true?

A: When you think of something like abdominal pain or GI symptoms, any place in the body can cause those symptoms to be present. You have to think broadly about all of the contributing factors, the whole patient as it relates to travel, pets, exposures, food, diet. You really can’t be myopic when you think about all the potential causes.

The name of the game is to provide answers whenever possible, but I will settle for getting someone feeling better, even if we don’t have the answer etched in stone.

Q: What gives you the most joy in your day-to-day practice?

A: I work in an academic institution at Johns Hopkins. I really enjoy the direct connection with patients. I’ve switched mostly to a hospital-based practice, which means I’m getting patients at their sickest. It’s really a privilege to provide an opportunity for improvement or support in that context. I also enjoy the teaching and training of the next generation of folks that are going into this field. There’s so much to learn, and I think trying to set that example and teach by doing is a great opportunity, and I really enjoy that as well.

Q: Describe your biggest practice-related challenge and what you’re doing to address it.A: One of my focus areas on the research front is about providing greater transparency and validation around health technologies. How do patients know which health technologies to use? How do doctors know which ones to recommend or advocate for?

Q: Can you give an example of a technology of concern?

A: Looking at oncology and mobile apps, one study I coauthored in 2021 found that well over half did not meet physician or patient expectations. These were the most popular and highest rated apps available at the time. It shows that there’s a real disconnect between what the end users – the doctors and the patients – want from these solutions and what’s actually being provided.

There’s a flood of different solutions that are out there, and there really isn’t a streamlined way to know, as a clinician or as a patient, which ones really make a difference clinically and which ones are going to be helpful for you. And that’s been the focus of my research – understanding ways to evaluate technologies that are not so burdensome as to be purely in the realm of academics, but to be pragmatic.

Q: Who has had the strongest influence on your life?

A: I would say my spouse. She’s an academic physician at Hopkins. One of the things she has shown me is the importance of finding alignment in what you do professionally with the sort of goals that you have or the values that you hold as an individual. That’s why I’ve done some nontraditional things in my academic career. It’s really been in search of finding that alignment that matches my interests and goals, as opposed to just doing something because it’s a popular thing to do.

Lightning Round

Favorite sport: Soccer

What song do you have to sing along with when you hear it? 80s pop music

Introvert or extrovert? Introvert

Favorite holiday: Christmas

Optimist or pessimist? Realist

Dr. Mathews is on LinkedIn . His health tech blog is Digital Differential.

Gastroenterologist Simon C. Mathews, MD, sees himself as a disciple of patient safety and quality improvement.

“It’s influenced the way I see medicine and the work that I do around identifying quality, not in the conventional context in a hospital or a clinic, but applying that lens to the world of technology,” said Dr. Mathews, assistant professor of medicine at Johns Hopkins Medicine in Baltimore.

Bringing greater visibility to digital health technologies is part of his life’s work.

“There is now an expectation that high quality must be part of the development process of these new technologies,” said Dr. Mathews.

In particular, he’d like to see noninvasive diagnostic technologies in the gastroenterology world become more patient-centric.

Bringing somebody into the hospital is often inconvenient and disruptive. The field is heading toward technologies that can be used in the home or in an outpatient setting. “I have some research in that area, and I’d love to see it ultimately reach the patient at the bedside, if possible.”

Dr. Mathews is a member of the AGA Center for GI Innovation and Technology and a previous mentee in the Future Leaders Program.

In an interview, Dr. Mathews discussed his push to validate health technologies in the GI field and to make them more transparent to physicians and patients.

Question: Why did you choose GI? 

Answer: I think the world of gastroenterology offers a tremendous amount of diversity in the way we manage and treat patients. There’s a huge spectrum of disease. There’s also the procedural aspect, which is very different from a lot of other medical specialties. For me particularly, there’s the opportunity to work on technology as it relates to GI, as well as research in that space.

Q: It seems like gastroenterology involves a lot of detective work. Would you say that’s true?

A: When you think of something like abdominal pain or GI symptoms, any place in the body can cause those symptoms to be present. You have to think broadly about all of the contributing factors, the whole patient as it relates to travel, pets, exposures, food, diet. You really can’t be myopic when you think about all the potential causes.

The name of the game is to provide answers whenever possible, but I will settle for getting someone feeling better, even if we don’t have the answer etched in stone.

Q: What gives you the most joy in your day-to-day practice?

A: I work in an academic institution at Johns Hopkins. I really enjoy the direct connection with patients. I’ve switched mostly to a hospital-based practice, which means I’m getting patients at their sickest. It’s really a privilege to provide an opportunity for improvement or support in that context. I also enjoy the teaching and training of the next generation of folks that are going into this field. There’s so much to learn, and I think trying to set that example and teach by doing is a great opportunity, and I really enjoy that as well.

Q: Describe your biggest practice-related challenge and what you’re doing to address it.A: One of my focus areas on the research front is about providing greater transparency and validation around health technologies. How do patients know which health technologies to use? How do doctors know which ones to recommend or advocate for?

Q: Can you give an example of a technology of concern?

A: Looking at oncology and mobile apps, one study I coauthored in 2021 found that well over half did not meet physician or patient expectations. These were the most popular and highest rated apps available at the time. It shows that there’s a real disconnect between what the end users – the doctors and the patients – want from these solutions and what’s actually being provided.

There’s a flood of different solutions that are out there, and there really isn’t a streamlined way to know, as a clinician or as a patient, which ones really make a difference clinically and which ones are going to be helpful for you. And that’s been the focus of my research – understanding ways to evaluate technologies that are not so burdensome as to be purely in the realm of academics, but to be pragmatic.

Q: Who has had the strongest influence on your life?

A: I would say my spouse. She’s an academic physician at Hopkins. One of the things she has shown me is the importance of finding alignment in what you do professionally with the sort of goals that you have or the values that you hold as an individual. That’s why I’ve done some nontraditional things in my academic career. It’s really been in search of finding that alignment that matches my interests and goals, as opposed to just doing something because it’s a popular thing to do.

Lightning Round

Favorite sport: Soccer

What song do you have to sing along with when you hear it? 80s pop music

Introvert or extrovert? Introvert

Favorite holiday: Christmas

Optimist or pessimist? Realist

Dr. Mathews is on LinkedIn . His health tech blog is Digital Differential.

Gastroenterologist Simon C. Mathews, MD, sees himself as a disciple of patient safety and quality improvement.

“It’s influenced the way I see medicine and the work that I do around identifying quality, not in the conventional context in a hospital or a clinic, but applying that lens to the world of technology,” said Dr. Mathews, assistant professor of medicine at Johns Hopkins Medicine in Baltimore.

Bringing greater visibility to digital health technologies is part of his life’s work.

“There is now an expectation that high quality must be part of the development process of these new technologies,” said Dr. Mathews.

In particular, he’d like to see noninvasive diagnostic technologies in the gastroenterology world become more patient-centric.

Bringing somebody into the hospital is often inconvenient and disruptive. The field is heading toward technologies that can be used in the home or in an outpatient setting. “I have some research in that area, and I’d love to see it ultimately reach the patient at the bedside, if possible.”

Dr. Mathews is a member of the AGA Center for GI Innovation and Technology and a previous mentee in the Future Leaders Program.

In an interview, Dr. Mathews discussed his push to validate health technologies in the GI field and to make them more transparent to physicians and patients.

Question: Why did you choose GI? 

Answer: I think the world of gastroenterology offers a tremendous amount of diversity in the way we manage and treat patients. There’s a huge spectrum of disease. There’s also the procedural aspect, which is very different from a lot of other medical specialties. For me particularly, there’s the opportunity to work on technology as it relates to GI, as well as research in that space.

Q: It seems like gastroenterology involves a lot of detective work. Would you say that’s true?

A: When you think of something like abdominal pain or GI symptoms, any place in the body can cause those symptoms to be present. You have to think broadly about all of the contributing factors, the whole patient as it relates to travel, pets, exposures, food, diet. You really can’t be myopic when you think about all the potential causes.

The name of the game is to provide answers whenever possible, but I will settle for getting someone feeling better, even if we don’t have the answer etched in stone.

Q: What gives you the most joy in your day-to-day practice?

A: I work in an academic institution at Johns Hopkins. I really enjoy the direct connection with patients. I’ve switched mostly to a hospital-based practice, which means I’m getting patients at their sickest. It’s really a privilege to provide an opportunity for improvement or support in that context. I also enjoy the teaching and training of the next generation of folks that are going into this field. There’s so much to learn, and I think trying to set that example and teach by doing is a great opportunity, and I really enjoy that as well.

Q: Describe your biggest practice-related challenge and what you’re doing to address it.A: One of my focus areas on the research front is about providing greater transparency and validation around health technologies. How do patients know which health technologies to use? How do doctors know which ones to recommend or advocate for?

Q: Can you give an example of a technology of concern?

A: Looking at oncology and mobile apps, one study I coauthored in 2021 found that well over half did not meet physician or patient expectations. These were the most popular and highest rated apps available at the time. It shows that there’s a real disconnect between what the end users – the doctors and the patients – want from these solutions and what’s actually being provided.

There’s a flood of different solutions that are out there, and there really isn’t a streamlined way to know, as a clinician or as a patient, which ones really make a difference clinically and which ones are going to be helpful for you. And that’s been the focus of my research – understanding ways to evaluate technologies that are not so burdensome as to be purely in the realm of academics, but to be pragmatic.

Q: Who has had the strongest influence on your life?

A: I would say my spouse. She’s an academic physician at Hopkins. One of the things she has shown me is the importance of finding alignment in what you do professionally with the sort of goals that you have or the values that you hold as an individual. That’s why I’ve done some nontraditional things in my academic career. It’s really been in search of finding that alignment that matches my interests and goals, as opposed to just doing something because it’s a popular thing to do.

Lightning Round

Favorite sport: Soccer

What song do you have to sing along with when you hear it? 80s pop music

Introvert or extrovert? Introvert

Favorite holiday: Christmas

Optimist or pessimist? Realist

Dr. Mathews is on LinkedIn . His health tech blog is Digital Differential.

Female physicians often spend their child-bearing years in medical training and developing their careers, and this can create problems.  

In a survey of just over 1,000 female oncologists, 95% said their career plans were at least somewhat associated with the timing of when to start a family.

The most striking finding was that one third of respondents had miscarried and another one third reported difficulty with infertility that required fertility counseling and/or treatment.

One third reported experiencing discrimination during pregnancy, and another third said they experienced discrimination for taking maternity leave, and having more than one child increased the likelihood of this.

The most common negative factor associated with family planning was long work hours and heavy workload (66.6%),

These findings suggest there are systemic changes needed not only in the healthcare setting but in society as a whole around women in the workplace and their choices of childbearing, say the authors.

The study was published online in JAMA Network Open and led by Anna Lee MD, MPH, from the department of radiation oncology, University of Texas MD Anderson Cancer Center, Houston. 

In an invited commentary, Mona Saleh, MD, and Stephanie Blank, MD, from the department of obstetrics, gynecology, and reproductive science at the Icahn School of Medicine at Mount Sinai in New York, suggest that cultural changes are needed that go beyond women in medicine.

“These cultural values are so deeply pervasive (one could also say invasive) that they affect even these most educated and wealthy professional women, such as those who participated in this survey,” the editorialists write.

“[The researchers] advocate for early education on assisted reproductive technology (ART) risks, benefits, and success rates, but this is not getting at the underlying issue: Pregnancy discrimination and unfair distribution of childbearing responsibilities are a reflection of a larger problematic culture rather than an issue specific to women in medicine,” they add.
 

Survey details

The survey comprised a novel 39-item questionnaire distributed to 1,004 U.S. female oncologists from May 7 to June 30, 2020, via email and social media channels.

Most respondents (84.4%) were married, and 71% were currently working full-time.

About one-third (35%) worked in radiation oncology, another third (34.3%) in medical oncology, 18.4% in surgical oncology, and 9.1% in pediatric oncology.

A total of 768 respondents (76.5%) had children, and of these, 415 (41.3%) first gave birth during postgraduate training and 275 (27.4%) gave birth in years 1-5 as an attending physician.

Of all respondents who had been pregnant, approximately two-thirds (65.7%) had some type of pregnancy complication. About one-third of respondents (31.7%) reported having experienced a miscarriage after a confirmed pregnancy; of those, 61.6% reported one miscarriage, while the remainder had two or more miscarriages (38.4%).

Approximately one-third (31.4%) of respondents reported difficulty with infertility that required fertility counseling and/or treatment.

The questionnaire also asked about assisted reproductive technology, and 164 participants (16.3%) reported the use of fertility medications, and 53 (5.3%) reported cryopreservation of eggs. Nearly 13% reported the use of intrauterine insemination and 13.2% reported the use of in vivo fertilization. Among those who experienced fertility concerns, 36.6% (232 of 634) reported facing financial burdens because of fertility or pregnancy that was in some way associated with their career choice.

When asked on the survey if fertility preservation should be discussed with women during medical school and/or residency, 65.7% of respondents stated that it should.

However, the editorialists suggest that “encouraging formal and directed education regarding the infertility risks specifically toward female physicians (which Lee et al. recommend) could be perceived as a blanket recommendation that it is best for women in medicine to delay childbearing and pursue ART.”

“Medical schools and residency and fellowship training programs should instead focus their energy on creating a framework and culture that normalizes conception during these points in training while also subsidizing and supporting trainees and physicians who prefer to use ART and delay fertility until after training,” they suggest.

The editorialists also emphasized that women may choose to become pregnant at any point during the years that it takes to go from being a medical student to resident/fellow to attending physician, and they should be supported by their workplace on their decisions.

The study was funded by grants from National Institutes of Health/National Cancer Institute Cancer Center.

Dr. Lee and coauthors reported no relevant financial relationships. Dr. Blank reported receiving grants from AstraZeneca, Aravive, Akesobio, GlaxoSmithKline, Merck, and Seattle Genetics outside the submitted work. Dr. Saleh reports no relevant financial relationships.

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

Female physicians often spend their child-bearing years in medical training and developing their careers, and this can create problems.  

In a survey of just over 1,000 female oncologists, 95% said their career plans were at least somewhat associated with the timing of when to start a family.

The most striking finding was that one third of respondents had miscarried and another one third reported difficulty with infertility that required fertility counseling and/or treatment.

One third reported experiencing discrimination during pregnancy, and another third said they experienced discrimination for taking maternity leave, and having more than one child increased the likelihood of this.

The most common negative factor associated with family planning was long work hours and heavy workload (66.6%),

These findings suggest there are systemic changes needed not only in the healthcare setting but in society as a whole around women in the workplace and their choices of childbearing, say the authors.

The study was published online in JAMA Network Open and led by Anna Lee MD, MPH, from the department of radiation oncology, University of Texas MD Anderson Cancer Center, Houston. 

In an invited commentary, Mona Saleh, MD, and Stephanie Blank, MD, from the department of obstetrics, gynecology, and reproductive science at the Icahn School of Medicine at Mount Sinai in New York, suggest that cultural changes are needed that go beyond women in medicine.

“These cultural values are so deeply pervasive (one could also say invasive) that they affect even these most educated and wealthy professional women, such as those who participated in this survey,” the editorialists write.

“[The researchers] advocate for early education on assisted reproductive technology (ART) risks, benefits, and success rates, but this is not getting at the underlying issue: Pregnancy discrimination and unfair distribution of childbearing responsibilities are a reflection of a larger problematic culture rather than an issue specific to women in medicine,” they add.
 

Survey details

The survey comprised a novel 39-item questionnaire distributed to 1,004 U.S. female oncologists from May 7 to June 30, 2020, via email and social media channels.

Most respondents (84.4%) were married, and 71% were currently working full-time.

About one-third (35%) worked in radiation oncology, another third (34.3%) in medical oncology, 18.4% in surgical oncology, and 9.1% in pediatric oncology.

A total of 768 respondents (76.5%) had children, and of these, 415 (41.3%) first gave birth during postgraduate training and 275 (27.4%) gave birth in years 1-5 as an attending physician.

Of all respondents who had been pregnant, approximately two-thirds (65.7%) had some type of pregnancy complication. About one-third of respondents (31.7%) reported having experienced a miscarriage after a confirmed pregnancy; of those, 61.6% reported one miscarriage, while the remainder had two or more miscarriages (38.4%).

Approximately one-third (31.4%) of respondents reported difficulty with infertility that required fertility counseling and/or treatment.

The questionnaire also asked about assisted reproductive technology, and 164 participants (16.3%) reported the use of fertility medications, and 53 (5.3%) reported cryopreservation of eggs. Nearly 13% reported the use of intrauterine insemination and 13.2% reported the use of in vivo fertilization. Among those who experienced fertility concerns, 36.6% (232 of 634) reported facing financial burdens because of fertility or pregnancy that was in some way associated with their career choice.

When asked on the survey if fertility preservation should be discussed with women during medical school and/or residency, 65.7% of respondents stated that it should.

However, the editorialists suggest that “encouraging formal and directed education regarding the infertility risks specifically toward female physicians (which Lee et al. recommend) could be perceived as a blanket recommendation that it is best for women in medicine to delay childbearing and pursue ART.”

“Medical schools and residency and fellowship training programs should instead focus their energy on creating a framework and culture that normalizes conception during these points in training while also subsidizing and supporting trainees and physicians who prefer to use ART and delay fertility until after training,” they suggest.

The editorialists also emphasized that women may choose to become pregnant at any point during the years that it takes to go from being a medical student to resident/fellow to attending physician, and they should be supported by their workplace on their decisions.

The study was funded by grants from National Institutes of Health/National Cancer Institute Cancer Center.

Dr. Lee and coauthors reported no relevant financial relationships. Dr. Blank reported receiving grants from AstraZeneca, Aravive, Akesobio, GlaxoSmithKline, Merck, and Seattle Genetics outside the submitted work. Dr. Saleh reports no relevant financial relationships.

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

Female physicians often spend their child-bearing years in medical training and developing their careers, and this can create problems.  

In a survey of just over 1,000 female oncologists, 95% said their career plans were at least somewhat associated with the timing of when to start a family.

The most striking finding was that one third of respondents had miscarried and another one third reported difficulty with infertility that required fertility counseling and/or treatment.

One third reported experiencing discrimination during pregnancy, and another third said they experienced discrimination for taking maternity leave, and having more than one child increased the likelihood of this.

The most common negative factor associated with family planning was long work hours and heavy workload (66.6%),

These findings suggest there are systemic changes needed not only in the healthcare setting but in society as a whole around women in the workplace and their choices of childbearing, say the authors.

The study was published online in JAMA Network Open and led by Anna Lee MD, MPH, from the department of radiation oncology, University of Texas MD Anderson Cancer Center, Houston. 

In an invited commentary, Mona Saleh, MD, and Stephanie Blank, MD, from the department of obstetrics, gynecology, and reproductive science at the Icahn School of Medicine at Mount Sinai in New York, suggest that cultural changes are needed that go beyond women in medicine.

“These cultural values are so deeply pervasive (one could also say invasive) that they affect even these most educated and wealthy professional women, such as those who participated in this survey,” the editorialists write.

“[The researchers] advocate for early education on assisted reproductive technology (ART) risks, benefits, and success rates, but this is not getting at the underlying issue: Pregnancy discrimination and unfair distribution of childbearing responsibilities are a reflection of a larger problematic culture rather than an issue specific to women in medicine,” they add.
 

Survey details

The survey comprised a novel 39-item questionnaire distributed to 1,004 U.S. female oncologists from May 7 to June 30, 2020, via email and social media channels.

Most respondents (84.4%) were married, and 71% were currently working full-time.

About one-third (35%) worked in radiation oncology, another third (34.3%) in medical oncology, 18.4% in surgical oncology, and 9.1% in pediatric oncology.

A total of 768 respondents (76.5%) had children, and of these, 415 (41.3%) first gave birth during postgraduate training and 275 (27.4%) gave birth in years 1-5 as an attending physician.

Of all respondents who had been pregnant, approximately two-thirds (65.7%) had some type of pregnancy complication. About one-third of respondents (31.7%) reported having experienced a miscarriage after a confirmed pregnancy; of those, 61.6% reported one miscarriage, while the remainder had two or more miscarriages (38.4%).

Approximately one-third (31.4%) of respondents reported difficulty with infertility that required fertility counseling and/or treatment.

The questionnaire also asked about assisted reproductive technology, and 164 participants (16.3%) reported the use of fertility medications, and 53 (5.3%) reported cryopreservation of eggs. Nearly 13% reported the use of intrauterine insemination and 13.2% reported the use of in vivo fertilization. Among those who experienced fertility concerns, 36.6% (232 of 634) reported facing financial burdens because of fertility or pregnancy that was in some way associated with their career choice.

When asked on the survey if fertility preservation should be discussed with women during medical school and/or residency, 65.7% of respondents stated that it should.

However, the editorialists suggest that “encouraging formal and directed education regarding the infertility risks specifically toward female physicians (which Lee et al. recommend) could be perceived as a blanket recommendation that it is best for women in medicine to delay childbearing and pursue ART.”

“Medical schools and residency and fellowship training programs should instead focus their energy on creating a framework and culture that normalizes conception during these points in training while also subsidizing and supporting trainees and physicians who prefer to use ART and delay fertility until after training,” they suggest.

The editorialists also emphasized that women may choose to become pregnant at any point during the years that it takes to go from being a medical student to resident/fellow to attending physician, and they should be supported by their workplace on their decisions.

The study was funded by grants from National Institutes of Health/National Cancer Institute Cancer Center.

Dr. Lee and coauthors reported no relevant financial relationships. Dr. Blank reported receiving grants from AstraZeneca, Aravive, Akesobio, GlaxoSmithKline, Merck, and Seattle Genetics outside the submitted work. Dr. Saleh reports no relevant financial relationships.

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

Too little sleep or poor sleep quality during the teen years can significantly increase the risk for multiple sclerosis (MS) during adulthood, new research suggests.

In a large case-control study, individuals who slept less than 7 hours a night on average during adolescence were 40% more likely to develop MS later on. The risk was even higher for those who rated their sleep quality as bad.

On the other hand, MS was significantly less common among individuals who slept longer as teens – indicating a possible protective benefit.

While sleep duration has been associated with mortality or disease risk for other conditions, sleep quality usually has little to no effect on risk, lead investigator Torbjörn Åkerstedt, PhD, sleep researcher and professor of psychology, department of neuroscience, Karolinska Institutet, Stockholm, told this news organization.

“I hadn’t really expected that, but those results were quite strong, even stronger than sleep duration,” Dr. Åkerstedt said.

“We don’t really know why this is happening in young age, but the most suitable explanation is that the brain in still developing quite a bit, and you’re interfering with it,” he added.

The findings were published online in the Journal of Neurology, Neurosurgery and Psychiatry.
 

Strong association

Other studies have tied sleep deprivation to increased risk for serious illness, but the link between sleep and MS risk isn’t as well studied.

Previous research by Dr. Åkerstedt showed that the risk for MS was higher among individuals who took part in shift work before the age of 20. However, the impact of sleep duration or quality among teens was unknown.

The current Swedish population-based case-control study included 2,075 patients with MS and 3,164 without the disorder. All participants were asked to recall how many hours on average they slept per night between the ages of 15 and 19 years and to rate their sleep quality during that time.

Results showed that individuals who slept fewer than 7 hours a night during their teen years were 40% more likely to have MS as adults (odds ratio [OR], 1.4; 95% confidence interval [CI], 1.1-1.7).

Poor sleep quality increased MS risk even more (OR, 1.5; 95% CI, 1.3-1.9).

The association remained strong even after adjustment for additional sleep on weekends and breaks and excluding shift workers.
 

Long sleep ‘apparently good’

The researchers also conducted several sensitivity studies to rule out confounders that might bias the association, such as excluding participants who reported currently experiencing less sleep or poor sleep.

“You would expect that people who are suffering from sleep problems today would be the people who reported sleep problems during their youth,” but that didn’t happen, Dr. Åkerstedt noted.

The investigators also entered data on sleep duration and sleep quality at the same time, thinking the data would cancel each other out. However, the association remained the same.

“Quite often you see that sleep duration would eliminate the effect of sleep complaints in the prediction of disease, but here both remain significant when they are entered at the same time,” Dr. Åkerstedt said. “You get the feeling that this might mean they act together to produce results,” he added.

“One other thing that surprised me is that long sleep was apparently good,” said Dr. Åkerstedt.

The investigators have conducted several studies on sleep duration and mortality. In recent research, they found that both short sleep and long sleep predicted mortality – “and often, long sleep is a stronger predictor than short sleep,” he said.
 

Underestimated problem?

Commenting on the findings, Kathleen Zackowski, PhD, associate vice president of research for the National Multiple Sclerosis Society in Baltimore, noted that participants were asked to rate their own sleep quality during adolescence, a subjective report that may mean sleep quality has an even larger association with MS risk.

“That they found a result with sleep quality says to me that there probably is a bigger problem, because I don’t know if people over- or underestimate their sleep quality,” said Dr. Zackowski, who was not involved with the research.

“If we could get to that sleep quality question a little more objectively, I bet that we’d find there’s a lot more to the story,” she said.

That’s a story the researchers would like to explore, Dr. Åkerstedt reported. Designing a prospective study that more closely tracks sleeping habits during adolescence and follows individuals through adulthood could provide valuable information about how sleep quality and duration affect immune system development and MS risk, he said.

Dr. Zackowski said clinicians know that MS is not caused just by a genetic abnormality and that other environmental lifestyle factors seem to play a part.

“If we find out that sleep is one of those lifestyle factors, this is very changeable,” she added.

The study was funded by the Swedish Research Council, the Swedish Research Council for Health, Working Life and Welfare, the Swedish Brain Foundation, AFA Insurance, the European Aviation Safety Authority, the Tercentenary Fund of the Bank of Sweden, the Margaretha af Ugglas Foundation, the Swedish Foundation for MS Research, and NEURO Sweden. Dr. Åkerstadt has been supported by Tercentenary Fund of Bank of Sweden, AFA Insurance, and the European Aviation Safety Authority. Dr. Zackowski reports no relevant financial relationships.

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

Too little sleep or poor sleep quality during the teen years can significantly increase the risk for multiple sclerosis (MS) during adulthood, new research suggests.

In a large case-control study, individuals who slept less than 7 hours a night on average during adolescence were 40% more likely to develop MS later on. The risk was even higher for those who rated their sleep quality as bad.

On the other hand, MS was significantly less common among individuals who slept longer as teens – indicating a possible protective benefit.

While sleep duration has been associated with mortality or disease risk for other conditions, sleep quality usually has little to no effect on risk, lead investigator Torbjörn Åkerstedt, PhD, sleep researcher and professor of psychology, department of neuroscience, Karolinska Institutet, Stockholm, told this news organization.

“I hadn’t really expected that, but those results were quite strong, even stronger than sleep duration,” Dr. Åkerstedt said.

“We don’t really know why this is happening in young age, but the most suitable explanation is that the brain in still developing quite a bit, and you’re interfering with it,” he added.

The findings were published online in the Journal of Neurology, Neurosurgery and Psychiatry.
 

Strong association

Other studies have tied sleep deprivation to increased risk for serious illness, but the link between sleep and MS risk isn’t as well studied.

Previous research by Dr. Åkerstedt showed that the risk for MS was higher among individuals who took part in shift work before the age of 20. However, the impact of sleep duration or quality among teens was unknown.

The current Swedish population-based case-control study included 2,075 patients with MS and 3,164 without the disorder. All participants were asked to recall how many hours on average they slept per night between the ages of 15 and 19 years and to rate their sleep quality during that time.

Results showed that individuals who slept fewer than 7 hours a night during their teen years were 40% more likely to have MS as adults (odds ratio [OR], 1.4; 95% confidence interval [CI], 1.1-1.7).

Poor sleep quality increased MS risk even more (OR, 1.5; 95% CI, 1.3-1.9).

The association remained strong even after adjustment for additional sleep on weekends and breaks and excluding shift workers.
 

Long sleep ‘apparently good’

The researchers also conducted several sensitivity studies to rule out confounders that might bias the association, such as excluding participants who reported currently experiencing less sleep or poor sleep.

“You would expect that people who are suffering from sleep problems today would be the people who reported sleep problems during their youth,” but that didn’t happen, Dr. Åkerstedt noted.

The investigators also entered data on sleep duration and sleep quality at the same time, thinking the data would cancel each other out. However, the association remained the same.

“Quite often you see that sleep duration would eliminate the effect of sleep complaints in the prediction of disease, but here both remain significant when they are entered at the same time,” Dr. Åkerstedt said. “You get the feeling that this might mean they act together to produce results,” he added.

“One other thing that surprised me is that long sleep was apparently good,” said Dr. Åkerstedt.

The investigators have conducted several studies on sleep duration and mortality. In recent research, they found that both short sleep and long sleep predicted mortality – “and often, long sleep is a stronger predictor than short sleep,” he said.
 

Underestimated problem?

Commenting on the findings, Kathleen Zackowski, PhD, associate vice president of research for the National Multiple Sclerosis Society in Baltimore, noted that participants were asked to rate their own sleep quality during adolescence, a subjective report that may mean sleep quality has an even larger association with MS risk.

“That they found a result with sleep quality says to me that there probably is a bigger problem, because I don’t know if people over- or underestimate their sleep quality,” said Dr. Zackowski, who was not involved with the research.

“If we could get to that sleep quality question a little more objectively, I bet that we’d find there’s a lot more to the story,” she said.

That’s a story the researchers would like to explore, Dr. Åkerstedt reported. Designing a prospective study that more closely tracks sleeping habits during adolescence and follows individuals through adulthood could provide valuable information about how sleep quality and duration affect immune system development and MS risk, he said.

Dr. Zackowski said clinicians know that MS is not caused just by a genetic abnormality and that other environmental lifestyle factors seem to play a part.

“If we find out that sleep is one of those lifestyle factors, this is very changeable,” she added.

The study was funded by the Swedish Research Council, the Swedish Research Council for Health, Working Life and Welfare, the Swedish Brain Foundation, AFA Insurance, the European Aviation Safety Authority, the Tercentenary Fund of the Bank of Sweden, the Margaretha af Ugglas Foundation, the Swedish Foundation for MS Research, and NEURO Sweden. Dr. Åkerstadt has been supported by Tercentenary Fund of Bank of Sweden, AFA Insurance, and the European Aviation Safety Authority. Dr. Zackowski reports no relevant financial relationships.

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

Too little sleep or poor sleep quality during the teen years can significantly increase the risk for multiple sclerosis (MS) during adulthood, new research suggests.

In a large case-control study, individuals who slept less than 7 hours a night on average during adolescence were 40% more likely to develop MS later on. The risk was even higher for those who rated their sleep quality as bad.

On the other hand, MS was significantly less common among individuals who slept longer as teens – indicating a possible protective benefit.

While sleep duration has been associated with mortality or disease risk for other conditions, sleep quality usually has little to no effect on risk, lead investigator Torbjörn Åkerstedt, PhD, sleep researcher and professor of psychology, department of neuroscience, Karolinska Institutet, Stockholm, told this news organization.

“I hadn’t really expected that, but those results were quite strong, even stronger than sleep duration,” Dr. Åkerstedt said.

“We don’t really know why this is happening in young age, but the most suitable explanation is that the brain in still developing quite a bit, and you’re interfering with it,” he added.

The findings were published online in the Journal of Neurology, Neurosurgery and Psychiatry.
 

Strong association

Other studies have tied sleep deprivation to increased risk for serious illness, but the link between sleep and MS risk isn’t as well studied.

Previous research by Dr. Åkerstedt showed that the risk for MS was higher among individuals who took part in shift work before the age of 20. However, the impact of sleep duration or quality among teens was unknown.

The current Swedish population-based case-control study included 2,075 patients with MS and 3,164 without the disorder. All participants were asked to recall how many hours on average they slept per night between the ages of 15 and 19 years and to rate their sleep quality during that time.

Results showed that individuals who slept fewer than 7 hours a night during their teen years were 40% more likely to have MS as adults (odds ratio [OR], 1.4; 95% confidence interval [CI], 1.1-1.7).

Poor sleep quality increased MS risk even more (OR, 1.5; 95% CI, 1.3-1.9).

The association remained strong even after adjustment for additional sleep on weekends and breaks and excluding shift workers.
 

Long sleep ‘apparently good’

The researchers also conducted several sensitivity studies to rule out confounders that might bias the association, such as excluding participants who reported currently experiencing less sleep or poor sleep.

“You would expect that people who are suffering from sleep problems today would be the people who reported sleep problems during their youth,” but that didn’t happen, Dr. Åkerstedt noted.

The investigators also entered data on sleep duration and sleep quality at the same time, thinking the data would cancel each other out. However, the association remained the same.

“Quite often you see that sleep duration would eliminate the effect of sleep complaints in the prediction of disease, but here both remain significant when they are entered at the same time,” Dr. Åkerstedt said. “You get the feeling that this might mean they act together to produce results,” he added.

“One other thing that surprised me is that long sleep was apparently good,” said Dr. Åkerstedt.

The investigators have conducted several studies on sleep duration and mortality. In recent research, they found that both short sleep and long sleep predicted mortality – “and often, long sleep is a stronger predictor than short sleep,” he said.
 

Underestimated problem?

Commenting on the findings, Kathleen Zackowski, PhD, associate vice president of research for the National Multiple Sclerosis Society in Baltimore, noted that participants were asked to rate their own sleep quality during adolescence, a subjective report that may mean sleep quality has an even larger association with MS risk.

“That they found a result with sleep quality says to me that there probably is a bigger problem, because I don’t know if people over- or underestimate their sleep quality,” said Dr. Zackowski, who was not involved with the research.

“If we could get to that sleep quality question a little more objectively, I bet that we’d find there’s a lot more to the story,” she said.

That’s a story the researchers would like to explore, Dr. Åkerstedt reported. Designing a prospective study that more closely tracks sleeping habits during adolescence and follows individuals through adulthood could provide valuable information about how sleep quality and duration affect immune system development and MS risk, he said.

Dr. Zackowski said clinicians know that MS is not caused just by a genetic abnormality and that other environmental lifestyle factors seem to play a part.

“If we find out that sleep is one of those lifestyle factors, this is very changeable,” she added.

The study was funded by the Swedish Research Council, the Swedish Research Council for Health, Working Life and Welfare, the Swedish Brain Foundation, AFA Insurance, the European Aviation Safety Authority, the Tercentenary Fund of the Bank of Sweden, the Margaretha af Ugglas Foundation, the Swedish Foundation for MS Research, and NEURO Sweden. Dr. Åkerstadt has been supported by Tercentenary Fund of Bank of Sweden, AFA Insurance, and the European Aviation Safety Authority. Dr. Zackowski reports no relevant financial relationships.

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

For a patient who needs a liver, living donation offers an alternative to staying on a list of more than 10,000 people waiting for a transplant. But what happens when your donor is not a match? To expand the number of living liver donations in the United States, the United Network for Organ Sharing (UNOS) has launched the first national paired liver donation pilot program.

“It’s an exciting time to be caring for patients who need liver transplants,” Benjamin Samstein, MD, chief of liver transplantation at New York–Presbyterian/Weill Cornell Medical Center, New York, said in an interview. He is the principal investigator for the UNOS pilot program. “I do believe it is within our grasp to make sure that nobody dies while waiting for an organ,” he said.

The initiative involves 15 U.S. transplant centers. So far, one recipient-donor pair has enrolled in the program. The pilot program has three main goals: Increase access to living donor transplants; increase access to transplants earlier, when recipients are in better health; and work out how to create and sustain a national program.
 

What is paired donation?

In 2020, 1,095 people died while waiting for a liver transplant, according to a report from the Organ Procurement and Transplant Network (OPTN) – a public-private partnership that includes more than 250 transplant centers and 50 organ procurement organizations across the country.

Most liver transplants involve deceased donors. One way to improve access to lifesaving transplants is through living donation, by which a healthy individual donates part of his or her liver. Someone can participate in nondirected or “altruistic” donation, in which someone donates a liver to someone they don’t know, or they can donate to a specific individual (usually a blood relative or a spouse).

With living liver donation, someone may receive a liver earlier, before getting sick enough to be given priority on the wait-list for deceased donation. Because the recipients are in better health, they may have an easier time recovering from the surgery, Ruthanne Leishman, who manages paired donation programs at UNOS, said in an interview.

In some cases, an individual will want to donate an organ to a specific person, but testing reveals that the two would not be a good match. Paired donation allows incompatible donors and recipients to find matches with other incompatible pairs. Each donor matches with the other pairs’ recipient, so the organs are essentially swapped or exchanged between the two pairs.

“People who want to donate get excited about the fact that they are not just helping their loved one but they’re also helping somebody else,” Ms. Leishman said.

Paired kidney donation programs have been running since 2002, but paired liver donation is relatively new. Since the first U.S. living-donor liver transplant in 1989, the procedure has become safer and is a viable alternative to deceased liver donation. A growing number of living donor programs are popping up at transplant centers across the country.

Still, living-donor liver donation makes up a small percentage of the liver transplants that are performed every year. In 2022, 603 living-donor liver transplants were performed in the United States, compared to 8,925 liver transplants from deceased donors, according to OPTN data. Dr. Samstein estimates a couple dozen paired liver exchanges may have been performed in the United States over the past few years within individual hospital systems. A goal of this pilot program, along with increasing access to liver transplants, is to see whether paired liver donation works on a national level, Ms. Leishman said.
 

Challenges to building a national program

There are several notable differences between living donor kidney transplants and living donor liver transplants. For example, living donor liver transplant is a more complicated surgery and poses greater risk to the donor. According to the OPTN 2020 Annual Report, from 2015 to 2019, the rehospitalization rate for living liver donors was twice that of living kidney donors up to 6 weeks after transplant (4.7% vs. 2.4%). One year post transplant, the cumulative rehospitalization rate was 11.0% for living liver donors and 4.8% for living kidney donors.

The risk of dying because of living donation is also higher for liver donors compared to kidney donors. The National Kidney Association states that the odds of dying during kidney donation are about 3 in 100,000, while estimates for risk of death for living liver donors range from 1 in 500 to 1 in 1,000. But some of these estimates are from 10 or more years ago, and outcomes have likely improved, said Whitney Jackson, MD, medical director of living donor liver transplant at UCHealth University of Colorado Hospital, Aurora. Her program is participating in the UNOS pilot.

More recent data from OPTN provides some idea of risk: Of 3,967 liver donors who donated between March 1, 2008, to Sept. 30, 2022, three deaths were reported within 30 days of transplant. However, the causes of death were not specified and therefore may be unrelated to the surgery. By comparison, of 74,555 kidney donors during that date range, 10 deaths were reported at 30 days post surgery.

In addition to a more complex surgery, surgeons also have a smaller time window in which to transplant a liver than than they do to transplant a kidney. A kidney can remain viable in cold storage for 24-36 hours, and it can be transported via commercial airlines cross country. Livers have to be transplanted within 8-12 hours, according to the OPTN website. For living donation, the graft needs to be transplanted within about 4 hours, Dr. Samstein noted; this poses a logistical challenge for a national organ paired donation program.

“We worked around that with the idea that we would move the donor rather than the organ,” he said. The program will require a donor (and a support person) to travel to the recipient’s transplant center where the surgery will be performed. While 3 of the 15 pilot paired donation transplant centers are in New York City, the other programs are scattered across the country, meaning a donor may have to fly to a different city to undergo surgery.

Including the preoperative evaluation, meeting the surgical team, the surgery itself, and follow-up, the donor could stay for about a month. The program offers up to $10,000 of financial assistance for travel expenses (for both the donor and support person), as well as lost wages and dependent care (for the donor only). Health insurance coverage will also be provided by the pilot program, in partnership with the American Foundation for Donation and Transplant.

The program requires that transplant candidates (the recipients) be at least 12 years old, be on the waiting list for deceased liver donation at one of the pilot’s transplant centers, and have a Model for End-Stage Liver Disease (MELD) score of 25 or less. All potential donors must be 18 years or older and must undergo a medical and psychosocial evaluation. Nondirected donors can register with the program, and they will be paired with a candidate on the liver transplant waiting list at the same transplant center.

The 1-year pilot program is set to begin when the program conducts its first match run – an algorithm will help match pairs who are enrolled in the program. About five to seven enrolled pairs would be ideal for the first match run, a UNOS spokesperson said. It is possible that the 1-year pilot program could run without performing any paired transplants, but that’s unlikely if multiple pairs are enrolled in the system, the spokesperson said. At the time of this story’s publication, the one enrolled pair are a mother and daughter who are registered at the UCHealth Transplant Center in Colorado.
 

Is a national liver paired donor program feasible?

While the UNOS pilot program offers financial assistance for expenses related to liver donation, some transplant surgeons are skeptical about the potential travel component of the pilot program.

The pilot program requires that the donor bring one support person if there is a need to travel for the surgery, but undergoing major abdominal surgery from a transplant team they are not familiar with may be stressful, said Peter Abt, MD, a transplant surgeon at the Hospital of the University of Pennsylvania and the Children’s Hospital of Philadelphia. “That’s a big ask,” he said, “and I’m not sure many potential donors would be up to that.”

John Roberts, MD, a transplant surgeon at the University of California, San Francisco, agreed that the travel component may put additional stress on the donor, but “if it’s the only way for the recipient to get a transplant, then the donor might be motivated,” he added.

Dr. Jackson remains optimistic. “Our experience so far has been that, yes, some people have been hesitant for things like traveling, but a lot of people who seem to be genuinely dedicated to the idea of living donation have been very enthusiastic,” she noted.

Dr. Leishman agreed that the travel aspect appears to one of the greatest barriers to participants entering the program but noted that a goal of the pilot program is to understand better what works - and what doesn’t – when considering a liver paired donation program on a national scale. “[Our] steering committee has put together a really nice framework that they think will work, but they know it’s not perfect. We’re going to have to tweak it along the way,” she said.

More information on the paired liver donation pilot program can be found on the UNOS website.

The sources interviewed for this article reported no financial conflicts of interest.

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

This article was updated 2/15/23.

For a patient who needs a liver, living donation offers an alternative to staying on a list of more than 10,000 people waiting for a transplant. But what happens when your donor is not a match? To expand the number of living liver donations in the United States, the United Network for Organ Sharing (UNOS) has launched the first national paired liver donation pilot program.

“It’s an exciting time to be caring for patients who need liver transplants,” Benjamin Samstein, MD, chief of liver transplantation at New York–Presbyterian/Weill Cornell Medical Center, New York, said in an interview. He is the principal investigator for the UNOS pilot program. “I do believe it is within our grasp to make sure that nobody dies while waiting for an organ,” he said.

The initiative involves 15 U.S. transplant centers. So far, one recipient-donor pair has enrolled in the program. The pilot program has three main goals: Increase access to living donor transplants; increase access to transplants earlier, when recipients are in better health; and work out how to create and sustain a national program.
 

What is paired donation?

In 2020, 1,095 people died while waiting for a liver transplant, according to a report from the Organ Procurement and Transplant Network (OPTN) – a public-private partnership that includes more than 250 transplant centers and 50 organ procurement organizations across the country.

Most liver transplants involve deceased donors. One way to improve access to lifesaving transplants is through living donation, by which a healthy individual donates part of his or her liver. Someone can participate in nondirected or “altruistic” donation, in which someone donates a liver to someone they don’t know, or they can donate to a specific individual (usually a blood relative or a spouse).

With living liver donation, someone may receive a liver earlier, before getting sick enough to be given priority on the wait-list for deceased donation. Because the recipients are in better health, they may have an easier time recovering from the surgery, Ruthanne Leishman, who manages paired donation programs at UNOS, said in an interview.

In some cases, an individual will want to donate an organ to a specific person, but testing reveals that the two would not be a good match. Paired donation allows incompatible donors and recipients to find matches with other incompatible pairs. Each donor matches with the other pairs’ recipient, so the organs are essentially swapped or exchanged between the two pairs.

“People who want to donate get excited about the fact that they are not just helping their loved one but they’re also helping somebody else,” Ms. Leishman said.

Paired kidney donation programs have been running since 2002, but paired liver donation is relatively new. Since the first U.S. living-donor liver transplant in 1989, the procedure has become safer and is a viable alternative to deceased liver donation. A growing number of living donor programs are popping up at transplant centers across the country.

Still, living-donor liver donation makes up a small percentage of the liver transplants that are performed every year. In 2022, 603 living-donor liver transplants were performed in the United States, compared to 8,925 liver transplants from deceased donors, according to OPTN data. Dr. Samstein estimates a couple dozen paired liver exchanges may have been performed in the United States over the past few years within individual hospital systems. A goal of this pilot program, along with increasing access to liver transplants, is to see whether paired liver donation works on a national level, Ms. Leishman said.
 

Challenges to building a national program

There are several notable differences between living donor kidney transplants and living donor liver transplants. For example, living donor liver transplant is a more complicated surgery and poses greater risk to the donor. According to the OPTN 2020 Annual Report, from 2015 to 2019, the rehospitalization rate for living liver donors was twice that of living kidney donors up to 6 weeks after transplant (4.7% vs. 2.4%). One year post transplant, the cumulative rehospitalization rate was 11.0% for living liver donors and 4.8% for living kidney donors.

The risk of dying because of living donation is also higher for liver donors compared to kidney donors. The National Kidney Association states that the odds of dying during kidney donation are about 3 in 100,000, while estimates for risk of death for living liver donors range from 1 in 500 to 1 in 1,000. But some of these estimates are from 10 or more years ago, and outcomes have likely improved, said Whitney Jackson, MD, medical director of living donor liver transplant at UCHealth University of Colorado Hospital, Aurora. Her program is participating in the UNOS pilot.

More recent data from OPTN provides some idea of risk: Of 3,967 liver donors who donated between March 1, 2008, to Sept. 30, 2022, three deaths were reported within 30 days of transplant. However, the causes of death were not specified and therefore may be unrelated to the surgery. By comparison, of 74,555 kidney donors during that date range, 10 deaths were reported at 30 days post surgery.

In addition to a more complex surgery, surgeons also have a smaller time window in which to transplant a liver than than they do to transplant a kidney. A kidney can remain viable in cold storage for 24-36 hours, and it can be transported via commercial airlines cross country. Livers have to be transplanted within 8-12 hours, according to the OPTN website. For living donation, the graft needs to be transplanted within about 4 hours, Dr. Samstein noted; this poses a logistical challenge for a national organ paired donation program.

“We worked around that with the idea that we would move the donor rather than the organ,” he said. The program will require a donor (and a support person) to travel to the recipient’s transplant center where the surgery will be performed. While 3 of the 15 pilot paired donation transplant centers are in New York City, the other programs are scattered across the country, meaning a donor may have to fly to a different city to undergo surgery.

Including the preoperative evaluation, meeting the surgical team, the surgery itself, and follow-up, the donor could stay for about a month. The program offers up to $10,000 of financial assistance for travel expenses (for both the donor and support person), as well as lost wages and dependent care (for the donor only). Health insurance coverage will also be provided by the pilot program, in partnership with the American Foundation for Donation and Transplant.

The program requires that transplant candidates (the recipients) be at least 12 years old, be on the waiting list for deceased liver donation at one of the pilot’s transplant centers, and have a Model for End-Stage Liver Disease (MELD) score of 25 or less. All potential donors must be 18 years or older and must undergo a medical and psychosocial evaluation. Nondirected donors can register with the program, and they will be paired with a candidate on the liver transplant waiting list at the same transplant center.

The 1-year pilot program is set to begin when the program conducts its first match run – an algorithm will help match pairs who are enrolled in the program. About five to seven enrolled pairs would be ideal for the first match run, a UNOS spokesperson said. It is possible that the 1-year pilot program could run without performing any paired transplants, but that’s unlikely if multiple pairs are enrolled in the system, the spokesperson said. At the time of this story’s publication, the one enrolled pair are a mother and daughter who are registered at the UCHealth Transplant Center in Colorado.
 

Is a national liver paired donor program feasible?

While the UNOS pilot program offers financial assistance for expenses related to liver donation, some transplant surgeons are skeptical about the potential travel component of the pilot program.

The pilot program requires that the donor bring one support person if there is a need to travel for the surgery, but undergoing major abdominal surgery from a transplant team they are not familiar with may be stressful, said Peter Abt, MD, a transplant surgeon at the Hospital of the University of Pennsylvania and the Children’s Hospital of Philadelphia. “That’s a big ask,” he said, “and I’m not sure many potential donors would be up to that.”

John Roberts, MD, a transplant surgeon at the University of California, San Francisco, agreed that the travel component may put additional stress on the donor, but “if it’s the only way for the recipient to get a transplant, then the donor might be motivated,” he added.

Dr. Jackson remains optimistic. “Our experience so far has been that, yes, some people have been hesitant for things like traveling, but a lot of people who seem to be genuinely dedicated to the idea of living donation have been very enthusiastic,” she noted.

Dr. Leishman agreed that the travel aspect appears to one of the greatest barriers to participants entering the program but noted that a goal of the pilot program is to understand better what works - and what doesn’t – when considering a liver paired donation program on a national scale. “[Our] steering committee has put together a really nice framework that they think will work, but they know it’s not perfect. We’re going to have to tweak it along the way,” she said.

More information on the paired liver donation pilot program can be found on the UNOS website.

The sources interviewed for this article reported no financial conflicts of interest.

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

This article was updated 2/15/23.

For a patient who needs a liver, living donation offers an alternative to staying on a list of more than 10,000 people waiting for a transplant. But what happens when your donor is not a match? To expand the number of living liver donations in the United States, the United Network for Organ Sharing (UNOS) has launched the first national paired liver donation pilot program.

“It’s an exciting time to be caring for patients who need liver transplants,” Benjamin Samstein, MD, chief of liver transplantation at New York–Presbyterian/Weill Cornell Medical Center, New York, said in an interview. He is the principal investigator for the UNOS pilot program. “I do believe it is within our grasp to make sure that nobody dies while waiting for an organ,” he said.

The initiative involves 15 U.S. transplant centers. So far, one recipient-donor pair has enrolled in the program. The pilot program has three main goals: Increase access to living donor transplants; increase access to transplants earlier, when recipients are in better health; and work out how to create and sustain a national program.
 

What is paired donation?

In 2020, 1,095 people died while waiting for a liver transplant, according to a report from the Organ Procurement and Transplant Network (OPTN) – a public-private partnership that includes more than 250 transplant centers and 50 organ procurement organizations across the country.

Most liver transplants involve deceased donors. One way to improve access to lifesaving transplants is through living donation, by which a healthy individual donates part of his or her liver. Someone can participate in nondirected or “altruistic” donation, in which someone donates a liver to someone they don’t know, or they can donate to a specific individual (usually a blood relative or a spouse).

With living liver donation, someone may receive a liver earlier, before getting sick enough to be given priority on the wait-list for deceased donation. Because the recipients are in better health, they may have an easier time recovering from the surgery, Ruthanne Leishman, who manages paired donation programs at UNOS, said in an interview.

In some cases, an individual will want to donate an organ to a specific person, but testing reveals that the two would not be a good match. Paired donation allows incompatible donors and recipients to find matches with other incompatible pairs. Each donor matches with the other pairs’ recipient, so the organs are essentially swapped or exchanged between the two pairs.

“People who want to donate get excited about the fact that they are not just helping their loved one but they’re also helping somebody else,” Ms. Leishman said.

Paired kidney donation programs have been running since 2002, but paired liver donation is relatively new. Since the first U.S. living-donor liver transplant in 1989, the procedure has become safer and is a viable alternative to deceased liver donation. A growing number of living donor programs are popping up at transplant centers across the country.

Still, living-donor liver donation makes up a small percentage of the liver transplants that are performed every year. In 2022, 603 living-donor liver transplants were performed in the United States, compared to 8,925 liver transplants from deceased donors, according to OPTN data. Dr. Samstein estimates a couple dozen paired liver exchanges may have been performed in the United States over the past few years within individual hospital systems. A goal of this pilot program, along with increasing access to liver transplants, is to see whether paired liver donation works on a national level, Ms. Leishman said.
 

Challenges to building a national program

There are several notable differences between living donor kidney transplants and living donor liver transplants. For example, living donor liver transplant is a more complicated surgery and poses greater risk to the donor. According to the OPTN 2020 Annual Report, from 2015 to 2019, the rehospitalization rate for living liver donors was twice that of living kidney donors up to 6 weeks after transplant (4.7% vs. 2.4%). One year post transplant, the cumulative rehospitalization rate was 11.0% for living liver donors and 4.8% for living kidney donors.

The risk of dying because of living donation is also higher for liver donors compared to kidney donors. The National Kidney Association states that the odds of dying during kidney donation are about 3 in 100,000, while estimates for risk of death for living liver donors range from 1 in 500 to 1 in 1,000. But some of these estimates are from 10 or more years ago, and outcomes have likely improved, said Whitney Jackson, MD, medical director of living donor liver transplant at UCHealth University of Colorado Hospital, Aurora. Her program is participating in the UNOS pilot.

More recent data from OPTN provides some idea of risk: Of 3,967 liver donors who donated between March 1, 2008, to Sept. 30, 2022, three deaths were reported within 30 days of transplant. However, the causes of death were not specified and therefore may be unrelated to the surgery. By comparison, of 74,555 kidney donors during that date range, 10 deaths were reported at 30 days post surgery.

In addition to a more complex surgery, surgeons also have a smaller time window in which to transplant a liver than than they do to transplant a kidney. A kidney can remain viable in cold storage for 24-36 hours, and it can be transported via commercial airlines cross country. Livers have to be transplanted within 8-12 hours, according to the OPTN website. For living donation, the graft needs to be transplanted within about 4 hours, Dr. Samstein noted; this poses a logistical challenge for a national organ paired donation program.

“We worked around that with the idea that we would move the donor rather than the organ,” he said. The program will require a donor (and a support person) to travel to the recipient’s transplant center where the surgery will be performed. While 3 of the 15 pilot paired donation transplant centers are in New York City, the other programs are scattered across the country, meaning a donor may have to fly to a different city to undergo surgery.

Including the preoperative evaluation, meeting the surgical team, the surgery itself, and follow-up, the donor could stay for about a month. The program offers up to $10,000 of financial assistance for travel expenses (for both the donor and support person), as well as lost wages and dependent care (for the donor only). Health insurance coverage will also be provided by the pilot program, in partnership with the American Foundation for Donation and Transplant.

The program requires that transplant candidates (the recipients) be at least 12 years old, be on the waiting list for deceased liver donation at one of the pilot’s transplant centers, and have a Model for End-Stage Liver Disease (MELD) score of 25 or less. All potential donors must be 18 years or older and must undergo a medical and psychosocial evaluation. Nondirected donors can register with the program, and they will be paired with a candidate on the liver transplant waiting list at the same transplant center.

The 1-year pilot program is set to begin when the program conducts its first match run – an algorithm will help match pairs who are enrolled in the program. About five to seven enrolled pairs would be ideal for the first match run, a UNOS spokesperson said. It is possible that the 1-year pilot program could run without performing any paired transplants, but that’s unlikely if multiple pairs are enrolled in the system, the spokesperson said. At the time of this story’s publication, the one enrolled pair are a mother and daughter who are registered at the UCHealth Transplant Center in Colorado.
 

Is a national liver paired donor program feasible?

While the UNOS pilot program offers financial assistance for expenses related to liver donation, some transplant surgeons are skeptical about the potential travel component of the pilot program.

The pilot program requires that the donor bring one support person if there is a need to travel for the surgery, but undergoing major abdominal surgery from a transplant team they are not familiar with may be stressful, said Peter Abt, MD, a transplant surgeon at the Hospital of the University of Pennsylvania and the Children’s Hospital of Philadelphia. “That’s a big ask,” he said, “and I’m not sure many potential donors would be up to that.”

John Roberts, MD, a transplant surgeon at the University of California, San Francisco, agreed that the travel component may put additional stress on the donor, but “if it’s the only way for the recipient to get a transplant, then the donor might be motivated,” he added.

Dr. Jackson remains optimistic. “Our experience so far has been that, yes, some people have been hesitant for things like traveling, but a lot of people who seem to be genuinely dedicated to the idea of living donation have been very enthusiastic,” she noted.

Dr. Leishman agreed that the travel aspect appears to one of the greatest barriers to participants entering the program but noted that a goal of the pilot program is to understand better what works - and what doesn’t – when considering a liver paired donation program on a national scale. “[Our] steering committee has put together a really nice framework that they think will work, but they know it’s not perfect. We’re going to have to tweak it along the way,” she said.

More information on the paired liver donation pilot program can be found on the UNOS website.

The sources interviewed for this article reported no financial conflicts of interest.

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

This article was updated 2/15/23.

Lower muscle mass was significantly associated with more airway obstruction and reduced functional exercise capacity in adults with asthma, based on data from 114 individuals.

Previous studies have shown reduced muscle mass in asthma patients, but the impact on clinical and functional outcomes has not been well studied, wrote Edith Visser, MSc, of Medical Centre Leeuwarden (the Netherlands) and colleagues.

“Many asthma patients, especially those with severe disease, report exercise intolerance and limitations in daily activities, severely affecting their quality of life,” they said. Research into the clinical consequences of low muscle mass and low muscle strength for patients with asthma and the role of inflammation could make muscle function a potential treatment target for those with asthma, they said.

In a study published in the Journal of Allergy and Clinical Immunology: In Practice, the researchers recruited 114 consecutive adults aged 18 years and older with a diagnosis of moderate to severe asthma who were seen at a single center between Jun. 2019 and Oct. 2022. The mean age of the patients was 51.9 years, 36% were men, 70% were overweight or obese, and 34 were diagnosed with severe asthma.

Participants underwent clinical, functional, and laboratory assessments at one or two visits within a 2-week period. Assessment tools included the Asthma Quality of Life Questionnaire (AQLQ), the Asthma Control Questionnaire (ACQ-6), a questionnaire on health care use (HCU), and the ‘short questionnaire to assess health-enhancing physical activity’ (SQUASH).

Functional activity was based on the 6-minute walking distance (6MWD), and lung function tests included spirometry and fractional inhaled nitric oxide (FeNO). Muscle mass was based on fat-free mass index (FFMI) and urinary creatinine excretion rate (CER). Muscle strength was measured using hand-grip strength (HGS).

The researchers examined levels of muscle mass and strength and their relation to functional and clinical outcomes.

Overall, the mean measures of muscle mass and strength were higher in males, who had average FFMI, CER, and HGS measures of 20.1 kg/m², 15.3 mmol/day, and 48.8 kg, respectively. These measures in women were 17.3 kg/m², 10.8 mmol/day, and 29.3 kg, respectively.

After adjusting for confounding factors, patients in the lowest tertile for muscle mass based on FFMI had significantly more severe asthma based on postbronchodilator forced expiratory volume in 1 second and FEV₁/forced vital capacity, as well as lower functional exercise capacity based on the 6MWD compared to those in the highest tertile. A similar association appeared between CER and FEV₁, but not FEV₁/FVC.

However, no significant associations appeared between the muscle mass measures of FFMI or CER and scores on the ACQ, AQLQ, emergency department visits, or asthma exacerbations, the researchers noted.

No relationship appeared between muscle strength and functional outcomes. However, patients in the lowest tertile of HGS had worse asthma control, worse quality of life, and a higher probability of at least one visit to the emergency department compared to patients in the highest HGS tertile.

Higher leukocyte levels were significantly associated with lower muscle mass after adjusting for age, sex, weight, and physical activity, but no other inflammatory markers were significantly associated with FFMI.

The association between lower muscle strength and poorer asthma control, lower quality of life, and greater odds of emergency department visits reflect findings from previous studies, the researchers said. The mechanisms behind the loss of muscle strength in asthma remain unclear, but physical inactivity and daily oral corticosteroid use may play a role, they added.

The study findings were limited by the cross-sectional design and the possibility that muscle weakness may instead stem from reduced physical activity associated with poor lung function and asthma control, the researchers noted. Other limitations included the potential overestimation of FFMI and the lack of statistical power to show a relationship between FFMI and emergency department visits and asthma exacerbations, they said.

However, the current study is the first known to explore the relationship between lower muscle mass and strength and a range of both functional and clinical outcomes in patients with moderate to severe asthma, they said.

“Our findings encourage longitudinal studies into muscle function as a potential target for treatment to improve asthma outcomes,” they concluded.

The study was supported by unrestricted grants from Medical Centre Leeuwarden research fund. Ms. Visser had no financial conflicts to disclose.

Lower muscle mass was significantly associated with more airway obstruction and reduced functional exercise capacity in adults with asthma, based on data from 114 individuals.

Previous studies have shown reduced muscle mass in asthma patients, but the impact on clinical and functional outcomes has not been well studied, wrote Edith Visser, MSc, of Medical Centre Leeuwarden (the Netherlands) and colleagues.

“Many asthma patients, especially those with severe disease, report exercise intolerance and limitations in daily activities, severely affecting their quality of life,” they said. Research into the clinical consequences of low muscle mass and low muscle strength for patients with asthma and the role of inflammation could make muscle function a potential treatment target for those with asthma, they said.

In a study published in the Journal of Allergy and Clinical Immunology: In Practice, the researchers recruited 114 consecutive adults aged 18 years and older with a diagnosis of moderate to severe asthma who were seen at a single center between Jun. 2019 and Oct. 2022. The mean age of the patients was 51.9 years, 36% were men, 70% were overweight or obese, and 34 were diagnosed with severe asthma.

Participants underwent clinical, functional, and laboratory assessments at one or two visits within a 2-week period. Assessment tools included the Asthma Quality of Life Questionnaire (AQLQ), the Asthma Control Questionnaire (ACQ-6), a questionnaire on health care use (HCU), and the ‘short questionnaire to assess health-enhancing physical activity’ (SQUASH).

Functional activity was based on the 6-minute walking distance (6MWD), and lung function tests included spirometry and fractional inhaled nitric oxide (FeNO). Muscle mass was based on fat-free mass index (FFMI) and urinary creatinine excretion rate (CER). Muscle strength was measured using hand-grip strength (HGS).

The researchers examined levels of muscle mass and strength and their relation to functional and clinical outcomes.

Overall, the mean measures of muscle mass and strength were higher in males, who had average FFMI, CER, and HGS measures of 20.1 kg/m², 15.3 mmol/day, and 48.8 kg, respectively. These measures in women were 17.3 kg/m², 10.8 mmol/day, and 29.3 kg, respectively.

After adjusting for confounding factors, patients in the lowest tertile for muscle mass based on FFMI had significantly more severe asthma based on postbronchodilator forced expiratory volume in 1 second and FEV₁/forced vital capacity, as well as lower functional exercise capacity based on the 6MWD compared to those in the highest tertile. A similar association appeared between CER and FEV₁, but not FEV₁/FVC.

However, no significant associations appeared between the muscle mass measures of FFMI or CER and scores on the ACQ, AQLQ, emergency department visits, or asthma exacerbations, the researchers noted.

No relationship appeared between muscle strength and functional outcomes. However, patients in the lowest tertile of HGS had worse asthma control, worse quality of life, and a higher probability of at least one visit to the emergency department compared to patients in the highest HGS tertile.

Higher leukocyte levels were significantly associated with lower muscle mass after adjusting for age, sex, weight, and physical activity, but no other inflammatory markers were significantly associated with FFMI.

The association between lower muscle strength and poorer asthma control, lower quality of life, and greater odds of emergency department visits reflect findings from previous studies, the researchers said. The mechanisms behind the loss of muscle strength in asthma remain unclear, but physical inactivity and daily oral corticosteroid use may play a role, they added.

The study findings were limited by the cross-sectional design and the possibility that muscle weakness may instead stem from reduced physical activity associated with poor lung function and asthma control, the researchers noted. Other limitations included the potential overestimation of FFMI and the lack of statistical power to show a relationship between FFMI and emergency department visits and asthma exacerbations, they said.

However, the current study is the first known to explore the relationship between lower muscle mass and strength and a range of both functional and clinical outcomes in patients with moderate to severe asthma, they said.

“Our findings encourage longitudinal studies into muscle function as a potential target for treatment to improve asthma outcomes,” they concluded.

The study was supported by unrestricted grants from Medical Centre Leeuwarden research fund. Ms. Visser had no financial conflicts to disclose.

Lower muscle mass was significantly associated with more airway obstruction and reduced functional exercise capacity in adults with asthma, based on data from 114 individuals.

Previous studies have shown reduced muscle mass in asthma patients, but the impact on clinical and functional outcomes has not been well studied, wrote Edith Visser, MSc, of Medical Centre Leeuwarden (the Netherlands) and colleagues.

“Many asthma patients, especially those with severe disease, report exercise intolerance and limitations in daily activities, severely affecting their quality of life,” they said. Research into the clinical consequences of low muscle mass and low muscle strength for patients with asthma and the role of inflammation could make muscle function a potential treatment target for those with asthma, they said.

In a study published in the Journal of Allergy and Clinical Immunology: In Practice, the researchers recruited 114 consecutive adults aged 18 years and older with a diagnosis of moderate to severe asthma who were seen at a single center between Jun. 2019 and Oct. 2022. The mean age of the patients was 51.9 years, 36% were men, 70% were overweight or obese, and 34 were diagnosed with severe asthma.

Participants underwent clinical, functional, and laboratory assessments at one or two visits within a 2-week period. Assessment tools included the Asthma Quality of Life Questionnaire (AQLQ), the Asthma Control Questionnaire (ACQ-6), a questionnaire on health care use (HCU), and the ‘short questionnaire to assess health-enhancing physical activity’ (SQUASH).

Functional activity was based on the 6-minute walking distance (6MWD), and lung function tests included spirometry and fractional inhaled nitric oxide (FeNO). Muscle mass was based on fat-free mass index (FFMI) and urinary creatinine excretion rate (CER). Muscle strength was measured using hand-grip strength (HGS).

The researchers examined levels of muscle mass and strength and their relation to functional and clinical outcomes.

Overall, the mean measures of muscle mass and strength were higher in males, who had average FFMI, CER, and HGS measures of 20.1 kg/m², 15.3 mmol/day, and 48.8 kg, respectively. These measures in women were 17.3 kg/m², 10.8 mmol/day, and 29.3 kg, respectively.

After adjusting for confounding factors, patients in the lowest tertile for muscle mass based on FFMI had significantly more severe asthma based on postbronchodilator forced expiratory volume in 1 second and FEV₁/forced vital capacity, as well as lower functional exercise capacity based on the 6MWD compared to those in the highest tertile. A similar association appeared between CER and FEV₁, but not FEV₁/FVC.

However, no significant associations appeared between the muscle mass measures of FFMI or CER and scores on the ACQ, AQLQ, emergency department visits, or asthma exacerbations, the researchers noted.

No relationship appeared between muscle strength and functional outcomes. However, patients in the lowest tertile of HGS had worse asthma control, worse quality of life, and a higher probability of at least one visit to the emergency department compared to patients in the highest HGS tertile.

Higher leukocyte levels were significantly associated with lower muscle mass after adjusting for age, sex, weight, and physical activity, but no other inflammatory markers were significantly associated with FFMI.

The association between lower muscle strength and poorer asthma control, lower quality of life, and greater odds of emergency department visits reflect findings from previous studies, the researchers said. The mechanisms behind the loss of muscle strength in asthma remain unclear, but physical inactivity and daily oral corticosteroid use may play a role, they added.

The study findings were limited by the cross-sectional design and the possibility that muscle weakness may instead stem from reduced physical activity associated with poor lung function and asthma control, the researchers noted. Other limitations included the potential overestimation of FFMI and the lack of statistical power to show a relationship between FFMI and emergency department visits and asthma exacerbations, they said.

However, the current study is the first known to explore the relationship between lower muscle mass and strength and a range of both functional and clinical outcomes in patients with moderate to severe asthma, they said.

“Our findings encourage longitudinal studies into muscle function as a potential target for treatment to improve asthma outcomes,” they concluded.

The study was supported by unrestricted grants from Medical Centre Leeuwarden research fund. Ms. Visser had no financial conflicts to disclose.