As 2020 comes to a close, most of us are looking forward to a (hopefully) brighter 2021. This year has been full of challenges and new experiences, but we have learned a lot. Pandemic or not, there are some things that you and your practice can do to ensure that you are prepared to make 2021 a success.

Tips for your practice

Assess staff morale: It seems simple but checking in with your staff can go a long way. Everyone is dealing with challenges both in and out of the workplace. Check in, show them you care, and think of ways that you can make their work a positive experience in the new year. During our May 2020 GI division chief townhall, John Inadomi, MD, gave a great presentation on the importance of staff morale during the pandemic.

Listen to colleagues: Find out about their experiences, challenges, and solutions. In October, the American Gastroenterological Association held a town hall with some great information and resources called “Adapting to Changing Practice Paradigms.” The agenda covered topics from telehealth to private equity and planning for the next potential wave of COVID-19.

Celebrate the wins: It can often feel like not much went right in 2020, but we did accomplish significant wins for GIs, including achieving payment parity for telephone evaluation and management (E/M) visits with video visits, increases in digestive disease and GI cancer research funding, and inclusion/expansion of GI cancers research opportunities. We couldn’t have done it without you, though, and we will continue to need your help to move important issues forward in 2021. Get involved today! Visit “Get Involved” under Advocacy and Policy on www.gastro.org.

Prepare for E/M changes: The Current Procedural Terminology (CPT) E/M for new and established patient office/outpatient codes (99201-99205, 99211-99215), guidelines, and Medicare payments will undergo major changes beginning Jan. 1, 2021. See the AGA’s coding and reimbursement experts’ article from the March 2020 issue of GI & Hepatology News, “Prepare for major changes to E/M coding starting in 2021,” to learn about the changes and get resources to help practices prepare.

Keep up with new Medicare payment rules: The release of the 2021 physician payments and rules for the Medicare program was delayed this year because of the COVID-19 public health emergency. We were dismayed to learn that Medicare did not make any changes that substantively mitigated the expected cuts to most specialties. Instead of a 5% cut for GI, the Centers for Medicare & Medicaid Services now projects GI will experience a 4% payment cut for 2021. AGA is calling on Congress to pass legislation to stop the cuts. This situation is evolving quickly. Watch for AGA member alerts for breaking news and resources, including the AGA’s “Medicare plans significant payment cuts for 2021.”

Stay current on telehealth and telephone E/M coverage: The commercial payer community came together to cover telehealth (video visits) and telephone E/M at the beginning of the COVID-19 pandemic but have since regularly teased the end of coverage only to extend it just before it expires. It’s impossible to predict what each payer will do, but you can use the following resources to keep current on most payers’ policies and correct coding/reporting for telehealth and telephone E/M:

• “Current State Laws & Reimbursement Policies ” from the Center for Connected Health.
• “Coding for Telehealth & Virtual Visits During COVID-19” from the AGA University.

Check to see if you can report on additional quality measures: AGA has expanded the Merit-Based Incentive Payment System (MIPS) measure portfolio by assuming ownership and stewardship of two hepatitis C virus (HCV) measures from PCPI, including annually checking for HCV in active injection drug users (measure 387) and performing a one-time screening for HCV among patients at risk (measure 400). As a result, gastroenterologists can now report on even more GI-specific measures. There have been the following two changes to GI-specific measures in 2021:

• Measure 275: “Inflammatory Bowel Disease (IBD): Assessment of Hepatitis B Virus (HBV) Status Before Initiating Anti-TNF (Tumor Necrosis Factor) Therapy” now includes coding to allow reporting for all age groups, including pediatric populations.
• Measure 439: “Age Appropriate Screening Colonoscopy” now includes all colonoscopies for patients 50 years and older; however, there’s an exclusion for those patients between the ages of 50 and 85 years.

These changes will help more gastroenterologists qualify for these measures.

Dates and deadlines to remember

January 2021

• Jan. 1 – MIPS Performance Year 2021 begins.
• Jan. 4 – Submission window opens for MIPS Performance Year 2020.
• Changes to Improvement Activity category go into effect (if approved in final rule).

March 2021

• March 31 – First snapshot for Qualifying Participant (QP) determinations and MIPS APM participation.

April 2021

• April 1 – Registration begins for CMS web interface and Consumer Assessment of Healthcare Providers and Systems (CAHPS) for MIPS survey.

June 2021

• June 30 – Second snapshot for QP determinations and MIPS APM participation.
• June 30 – Registration ends for CMS web interface and CAHPS for MIPS survey.

July 2021

• CMS publishes proposed reimbursement values for 2022 in the Medicare Physician Fee Schedule proposed rule.
• CMS “Targeted Review” opens once CMS makes your MIPS payment adjustment available.
• July 1 - MIPS Performance Feedback Available. CMS will provide you with performance feedback based on the data you submitted for Performance Year 2020. You can use this feedback to improve your care and optimize the payments you receive from CMS in the future.

August 2021

• Aug. 31 - Targeted Review period closes (appeals process).

September 2021

• AMA releases CPT 2022 book, including a new CPT code for Peroral Endoscopic Myotomy (POEM).

October 2021

• Oct. 3 - Last day to start a 90-day performance period for promoting Interoperability and Improvement Activities.

November 2021

• CMS finalizes reimbursement values for 2022 in the MPFS final rule. New payment rates take effect Jan. 1, 2022.

December 2021

• Dec. 31 – Quality Payment Program Exception Applications window closes.
• Dec. 31 – MIPS Performance year 2020 ends.
• Dec. 31 – Fourth snapshot for full TIN APMs (Medicare Shared Savings Program).

G. Anton Decker, MD, is chair of the AGA Practice Management and Economics Committee, Mayo Clinic International; Dawn Francis, MD, is chair-elect of the AGA Practice Management and Economics Committee, Mayo Clinic, Jacksonville, Fla.

They have no conflicts of interest.

As 2020 comes to a close, most of us are looking forward to a (hopefully) brighter 2021. This year has been full of challenges and new experiences, but we have learned a lot. Pandemic or not, there are some things that you and your practice can do to ensure that you are prepared to make 2021 a success.

Tips for your practice

Assess staff morale: It seems simple but checking in with your staff can go a long way. Everyone is dealing with challenges both in and out of the workplace. Check in, show them you care, and think of ways that you can make their work a positive experience in the new year. During our May 2020 GI division chief townhall, John Inadomi, MD, gave a great presentation on the importance of staff morale during the pandemic.

Listen to colleagues: Find out about their experiences, challenges, and solutions. In October, the American Gastroenterological Association held a town hall with some great information and resources called “Adapting to Changing Practice Paradigms.” The agenda covered topics from telehealth to private equity and planning for the next potential wave of COVID-19.

Celebrate the wins: It can often feel like not much went right in 2020, but we did accomplish significant wins for GIs, including achieving payment parity for telephone evaluation and management (E/M) visits with video visits, increases in digestive disease and GI cancer research funding, and inclusion/expansion of GI cancers research opportunities. We couldn’t have done it without you, though, and we will continue to need your help to move important issues forward in 2021. Get involved today! Visit “Get Involved” under Advocacy and Policy on www.gastro.org.

Prepare for E/M changes: The Current Procedural Terminology (CPT) E/M for new and established patient office/outpatient codes (99201-99205, 99211-99215), guidelines, and Medicare payments will undergo major changes beginning Jan. 1, 2021. See the AGA’s coding and reimbursement experts’ article from the March 2020 issue of GI & Hepatology News, “Prepare for major changes to E/M coding starting in 2021,” to learn about the changes and get resources to help practices prepare.

Keep up with new Medicare payment rules: The release of the 2021 physician payments and rules for the Medicare program was delayed this year because of the COVID-19 public health emergency. We were dismayed to learn that Medicare did not make any changes that substantively mitigated the expected cuts to most specialties. Instead of a 5% cut for GI, the Centers for Medicare & Medicaid Services now projects GI will experience a 4% payment cut for 2021. AGA is calling on Congress to pass legislation to stop the cuts. This situation is evolving quickly. Watch for AGA member alerts for breaking news and resources, including the AGA’s “Medicare plans significant payment cuts for 2021.”

Stay current on telehealth and telephone E/M coverage: The commercial payer community came together to cover telehealth (video visits) and telephone E/M at the beginning of the COVID-19 pandemic but have since regularly teased the end of coverage only to extend it just before it expires. It’s impossible to predict what each payer will do, but you can use the following resources to keep current on most payers’ policies and correct coding/reporting for telehealth and telephone E/M:

• “Current State Laws & Reimbursement Policies ” from the Center for Connected Health.
• “Coding for Telehealth & Virtual Visits During COVID-19” from the AGA University.

Check to see if you can report on additional quality measures: AGA has expanded the Merit-Based Incentive Payment System (MIPS) measure portfolio by assuming ownership and stewardship of two hepatitis C virus (HCV) measures from PCPI, including annually checking for HCV in active injection drug users (measure 387) and performing a one-time screening for HCV among patients at risk (measure 400). As a result, gastroenterologists can now report on even more GI-specific measures. There have been the following two changes to GI-specific measures in 2021:

• Measure 275: “Inflammatory Bowel Disease (IBD): Assessment of Hepatitis B Virus (HBV) Status Before Initiating Anti-TNF (Tumor Necrosis Factor) Therapy” now includes coding to allow reporting for all age groups, including pediatric populations.
• Measure 439: “Age Appropriate Screening Colonoscopy” now includes all colonoscopies for patients 50 years and older; however, there’s an exclusion for those patients between the ages of 50 and 85 years.

These changes will help more gastroenterologists qualify for these measures.

Dates and deadlines to remember

January 2021

• Jan. 1 – MIPS Performance Year 2021 begins.
• Jan. 4 – Submission window opens for MIPS Performance Year 2020.
• Changes to Improvement Activity category go into effect (if approved in final rule).

March 2021

• March 31 – First snapshot for Qualifying Participant (QP) determinations and MIPS APM participation.

April 2021

• April 1 – Registration begins for CMS web interface and Consumer Assessment of Healthcare Providers and Systems (CAHPS) for MIPS survey.

June 2021

• June 30 – Second snapshot for QP determinations and MIPS APM participation.
• June 30 – Registration ends for CMS web interface and CAHPS for MIPS survey.

July 2021

• CMS publishes proposed reimbursement values for 2022 in the Medicare Physician Fee Schedule proposed rule.
• CMS “Targeted Review” opens once CMS makes your MIPS payment adjustment available.
• July 1 - MIPS Performance Feedback Available. CMS will provide you with performance feedback based on the data you submitted for Performance Year 2020. You can use this feedback to improve your care and optimize the payments you receive from CMS in the future.

August 2021

• Aug. 31 - Targeted Review period closes (appeals process).

September 2021

• AMA releases CPT 2022 book, including a new CPT code for Peroral Endoscopic Myotomy (POEM).

October 2021

• Oct. 3 - Last day to start a 90-day performance period for promoting Interoperability and Improvement Activities.

November 2021

• CMS finalizes reimbursement values for 2022 in the MPFS final rule. New payment rates take effect Jan. 1, 2022.

December 2021

• Dec. 31 – Quality Payment Program Exception Applications window closes.
• Dec. 31 – MIPS Performance year 2020 ends.
• Dec. 31 – Fourth snapshot for full TIN APMs (Medicare Shared Savings Program).

G. Anton Decker, MD, is chair of the AGA Practice Management and Economics Committee, Mayo Clinic International; Dawn Francis, MD, is chair-elect of the AGA Practice Management and Economics Committee, Mayo Clinic, Jacksonville, Fla.

They have no conflicts of interest.

As 2020 comes to a close, most of us are looking forward to a (hopefully) brighter 2021. This year has been full of challenges and new experiences, but we have learned a lot. Pandemic or not, there are some things that you and your practice can do to ensure that you are prepared to make 2021 a success.

Tips for your practice

Assess staff morale: It seems simple but checking in with your staff can go a long way. Everyone is dealing with challenges both in and out of the workplace. Check in, show them you care, and think of ways that you can make their work a positive experience in the new year. During our May 2020 GI division chief townhall, John Inadomi, MD, gave a great presentation on the importance of staff morale during the pandemic.

Listen to colleagues: Find out about their experiences, challenges, and solutions. In October, the American Gastroenterological Association held a town hall with some great information and resources called “Adapting to Changing Practice Paradigms.” The agenda covered topics from telehealth to private equity and planning for the next potential wave of COVID-19.

Celebrate the wins: It can often feel like not much went right in 2020, but we did accomplish significant wins for GIs, including achieving payment parity for telephone evaluation and management (E/M) visits with video visits, increases in digestive disease and GI cancer research funding, and inclusion/expansion of GI cancers research opportunities. We couldn’t have done it without you, though, and we will continue to need your help to move important issues forward in 2021. Get involved today! Visit “Get Involved” under Advocacy and Policy on www.gastro.org.

Prepare for E/M changes: The Current Procedural Terminology (CPT) E/M for new and established patient office/outpatient codes (99201-99205, 99211-99215), guidelines, and Medicare payments will undergo major changes beginning Jan. 1, 2021. See the AGA’s coding and reimbursement experts’ article from the March 2020 issue of GI & Hepatology News, “Prepare for major changes to E/M coding starting in 2021,” to learn about the changes and get resources to help practices prepare.

Keep up with new Medicare payment rules: The release of the 2021 physician payments and rules for the Medicare program was delayed this year because of the COVID-19 public health emergency. We were dismayed to learn that Medicare did not make any changes that substantively mitigated the expected cuts to most specialties. Instead of a 5% cut for GI, the Centers for Medicare & Medicaid Services now projects GI will experience a 4% payment cut for 2021. AGA is calling on Congress to pass legislation to stop the cuts. This situation is evolving quickly. Watch for AGA member alerts for breaking news and resources, including the AGA’s “Medicare plans significant payment cuts for 2021.”

Stay current on telehealth and telephone E/M coverage: The commercial payer community came together to cover telehealth (video visits) and telephone E/M at the beginning of the COVID-19 pandemic but have since regularly teased the end of coverage only to extend it just before it expires. It’s impossible to predict what each payer will do, but you can use the following resources to keep current on most payers’ policies and correct coding/reporting for telehealth and telephone E/M:

• “Current State Laws & Reimbursement Policies ” from the Center for Connected Health.
• “Coding for Telehealth & Virtual Visits During COVID-19” from the AGA University.

Check to see if you can report on additional quality measures: AGA has expanded the Merit-Based Incentive Payment System (MIPS) measure portfolio by assuming ownership and stewardship of two hepatitis C virus (HCV) measures from PCPI, including annually checking for HCV in active injection drug users (measure 387) and performing a one-time screening for HCV among patients at risk (measure 400). As a result, gastroenterologists can now report on even more GI-specific measures. There have been the following two changes to GI-specific measures in 2021:

• Measure 275: “Inflammatory Bowel Disease (IBD): Assessment of Hepatitis B Virus (HBV) Status Before Initiating Anti-TNF (Tumor Necrosis Factor) Therapy” now includes coding to allow reporting for all age groups, including pediatric populations.
• Measure 439: “Age Appropriate Screening Colonoscopy” now includes all colonoscopies for patients 50 years and older; however, there’s an exclusion for those patients between the ages of 50 and 85 years.

These changes will help more gastroenterologists qualify for these measures.

Dates and deadlines to remember

January 2021

• Jan. 1 – MIPS Performance Year 2021 begins.
• Jan. 4 – Submission window opens for MIPS Performance Year 2020.
• Changes to Improvement Activity category go into effect (if approved in final rule).

March 2021

• March 31 – First snapshot for Qualifying Participant (QP) determinations and MIPS APM participation.

April 2021

• April 1 – Registration begins for CMS web interface and Consumer Assessment of Healthcare Providers and Systems (CAHPS) for MIPS survey.

June 2021

• June 30 – Second snapshot for QP determinations and MIPS APM participation.
• June 30 – Registration ends for CMS web interface and CAHPS for MIPS survey.

July 2021

• CMS publishes proposed reimbursement values for 2022 in the Medicare Physician Fee Schedule proposed rule.
• CMS “Targeted Review” opens once CMS makes your MIPS payment adjustment available.
• July 1 - MIPS Performance Feedback Available. CMS will provide you with performance feedback based on the data you submitted for Performance Year 2020. You can use this feedback to improve your care and optimize the payments you receive from CMS in the future.

August 2021

• Aug. 31 - Targeted Review period closes (appeals process).

September 2021

• AMA releases CPT 2022 book, including a new CPT code for Peroral Endoscopic Myotomy (POEM).

October 2021

• Oct. 3 - Last day to start a 90-day performance period for promoting Interoperability and Improvement Activities.

November 2021

• CMS finalizes reimbursement values for 2022 in the MPFS final rule. New payment rates take effect Jan. 1, 2022.

December 2021

• Dec. 31 – Quality Payment Program Exception Applications window closes.
• Dec. 31 – MIPS Performance year 2020 ends.
• Dec. 31 – Fourth snapshot for full TIN APMs (Medicare Shared Savings Program).

G. Anton Decker, MD, is chair of the AGA Practice Management and Economics Committee, Mayo Clinic International; Dawn Francis, MD, is chair-elect of the AGA Practice Management and Economics Committee, Mayo Clinic, Jacksonville, Fla.

They have no conflicts of interest.

Relapse in ulcerative colitis patients with endoscopic remission was unaffected by histologic remission status, based on data from a retrospective study of 269 adults.

Data from previous studies suggest that histologic remission may be the strongest predictor of prognosis of disease course, wrote Neeraj Narula, MD, of McMaster University, Hamilton, Ont., and colleagues.

“However, it is unclear if UC patients who have achieved endoscopic healing have additional benefit in clinical outcomes if they have achieved histologic remission as well compared to those with ongoing histology activity,” they said.

In a study published in Alimentary Pharmacology and Therapeutics, the researchers identified 269 adults with ulcerative colitis who had endoscopic remission. Of these, 53 had normal histology, 138 had histologically inactive colitis, and 78 had histologically active colitis.

Overall, clinical relapse occurred in 64 patients, including 12 with normal histology (22.6%), 32 with inactive colitis (23.2%), and 29 with active colitis (25.6%).

No significant difference occurred in the time to relapse in patients with inactive vs. active colitis (adjusted hazard ratio 1.17, P = .67) or in patients with normal histology vs. inactive histology (AHR 0.67, P = .39). The median time to relapse was 2.92 years, 3.0 years, and 4.0 years in the normal, inactive, and active groups, respectively. Factors associated with a shorter time to relapse included older age at colonoscopy, use of 5-aminosalicylic acid, and disease extent in cases of pancolitis and left-sided colitis.

The study findings were limited by several factors including the possibility of bias in histologic scoring, lack of objective measures of disease activity, and the lack of uniformity is histologic assessment, the researchers noted. However, the results were strengthened by the large size compared with previous studies and by the adjustments for known confounding factors, they said.

“While clinical and endoscopic remission [is the target] of therapy for patients with UC, our study does not support targeting histologic remission in patients who have already achieved endoscopic remission,” they concluded.
 

More research may support clinical applications

“I was rather surprised by the findings, as a majority of studies have shown that histologic healing more accurately predicts clinical relapse than endoscopic remission in UC,” Atsushi Sakuraba, MD, of the University of Chicago, said in an interview.

“Although of a good sample size, this was a retrospective study, so no firm conclusion can be made,” said Dr. Sakuraba. “Using histologic healing as a therapeutic goal is still an evolving field, and it is too early to draw a conclusion as to whether (or not) to introduce histologic healing in clinical decision making,” he emphasized. 

Going forward, prospective studies are needed that match for confounders such as postendoscopy medication use, age, and disease extent, Dr. Sakuraba said.

The study received no outside funding. Lead author Dr. Narula disclosed honoraria from Janssen, AbbVie, Takeda, Pfizer, Merck, and Ferring. Dr. Sakuraba had no financial conflicts to disclose.

SOURCE: Narula N et al. Aliment Pharmacol Ther. 2020 Nov 1. doi: 10.1111/apt.16147.

Relapse in ulcerative colitis patients with endoscopic remission was unaffected by histologic remission status, based on data from a retrospective study of 269 adults.

Data from previous studies suggest that histologic remission may be the strongest predictor of prognosis of disease course, wrote Neeraj Narula, MD, of McMaster University, Hamilton, Ont., and colleagues.

“However, it is unclear if UC patients who have achieved endoscopic healing have additional benefit in clinical outcomes if they have achieved histologic remission as well compared to those with ongoing histology activity,” they said.

In a study published in Alimentary Pharmacology and Therapeutics, the researchers identified 269 adults with ulcerative colitis who had endoscopic remission. Of these, 53 had normal histology, 138 had histologically inactive colitis, and 78 had histologically active colitis.

Overall, clinical relapse occurred in 64 patients, including 12 with normal histology (22.6%), 32 with inactive colitis (23.2%), and 29 with active colitis (25.6%).

No significant difference occurred in the time to relapse in patients with inactive vs. active colitis (adjusted hazard ratio 1.17, P = .67) or in patients with normal histology vs. inactive histology (AHR 0.67, P = .39). The median time to relapse was 2.92 years, 3.0 years, and 4.0 years in the normal, inactive, and active groups, respectively. Factors associated with a shorter time to relapse included older age at colonoscopy, use of 5-aminosalicylic acid, and disease extent in cases of pancolitis and left-sided colitis.

The study findings were limited by several factors including the possibility of bias in histologic scoring, lack of objective measures of disease activity, and the lack of uniformity is histologic assessment, the researchers noted. However, the results were strengthened by the large size compared with previous studies and by the adjustments for known confounding factors, they said.

“While clinical and endoscopic remission [is the target] of therapy for patients with UC, our study does not support targeting histologic remission in patients who have already achieved endoscopic remission,” they concluded.
 

More research may support clinical applications

“I was rather surprised by the findings, as a majority of studies have shown that histologic healing more accurately predicts clinical relapse than endoscopic remission in UC,” Atsushi Sakuraba, MD, of the University of Chicago, said in an interview.

“Although of a good sample size, this was a retrospective study, so no firm conclusion can be made,” said Dr. Sakuraba. “Using histologic healing as a therapeutic goal is still an evolving field, and it is too early to draw a conclusion as to whether (or not) to introduce histologic healing in clinical decision making,” he emphasized. 

Going forward, prospective studies are needed that match for confounders such as postendoscopy medication use, age, and disease extent, Dr. Sakuraba said.

The study received no outside funding. Lead author Dr. Narula disclosed honoraria from Janssen, AbbVie, Takeda, Pfizer, Merck, and Ferring. Dr. Sakuraba had no financial conflicts to disclose.

SOURCE: Narula N et al. Aliment Pharmacol Ther. 2020 Nov 1. doi: 10.1111/apt.16147.

Relapse in ulcerative colitis patients with endoscopic remission was unaffected by histologic remission status, based on data from a retrospective study of 269 adults.

Data from previous studies suggest that histologic remission may be the strongest predictor of prognosis of disease course, wrote Neeraj Narula, MD, of McMaster University, Hamilton, Ont., and colleagues.

“However, it is unclear if UC patients who have achieved endoscopic healing have additional benefit in clinical outcomes if they have achieved histologic remission as well compared to those with ongoing histology activity,” they said.

In a study published in Alimentary Pharmacology and Therapeutics, the researchers identified 269 adults with ulcerative colitis who had endoscopic remission. Of these, 53 had normal histology, 138 had histologically inactive colitis, and 78 had histologically active colitis.

Overall, clinical relapse occurred in 64 patients, including 12 with normal histology (22.6%), 32 with inactive colitis (23.2%), and 29 with active colitis (25.6%).

No significant difference occurred in the time to relapse in patients with inactive vs. active colitis (adjusted hazard ratio 1.17, P = .67) or in patients with normal histology vs. inactive histology (AHR 0.67, P = .39). The median time to relapse was 2.92 years, 3.0 years, and 4.0 years in the normal, inactive, and active groups, respectively. Factors associated with a shorter time to relapse included older age at colonoscopy, use of 5-aminosalicylic acid, and disease extent in cases of pancolitis and left-sided colitis.

The study findings were limited by several factors including the possibility of bias in histologic scoring, lack of objective measures of disease activity, and the lack of uniformity is histologic assessment, the researchers noted. However, the results were strengthened by the large size compared with previous studies and by the adjustments for known confounding factors, they said.

“While clinical and endoscopic remission [is the target] of therapy for patients with UC, our study does not support targeting histologic remission in patients who have already achieved endoscopic remission,” they concluded.
 

More research may support clinical applications

“I was rather surprised by the findings, as a majority of studies have shown that histologic healing more accurately predicts clinical relapse than endoscopic remission in UC,” Atsushi Sakuraba, MD, of the University of Chicago, said in an interview.

“Although of a good sample size, this was a retrospective study, so no firm conclusion can be made,” said Dr. Sakuraba. “Using histologic healing as a therapeutic goal is still an evolving field, and it is too early to draw a conclusion as to whether (or not) to introduce histologic healing in clinical decision making,” he emphasized. 

Going forward, prospective studies are needed that match for confounders such as postendoscopy medication use, age, and disease extent, Dr. Sakuraba said.

The study received no outside funding. Lead author Dr. Narula disclosed honoraria from Janssen, AbbVie, Takeda, Pfizer, Merck, and Ferring. Dr. Sakuraba had no financial conflicts to disclose.

SOURCE: Narula N et al. Aliment Pharmacol Ther. 2020 Nov 1. doi: 10.1111/apt.16147.

Despite the lack of any Food and Drug Administration–approved medications for vitiligo, there are plenty of treatment options, and therapy can make a big difference in an individual’s quality of life, according to Seemal Desai, MD, of the University of Texas, Dallas.

“We have topical steroids. We have vitamin D analogs, calcineurin inhibitors, and depigmentation therapy. We also have systemic therapy, phototherapy, surgical treatment, and even psychological therapy, Dr. Desai said in a presentation at MedscapeLive’s virtual Women’s & Pediatric Dermatology Seminar.

Head and neck vitiligo, which “tends to respond very nicely to treatment,” is one of the affected areas “where we have an important obligation to make sure our patients are effectively and aggressively treated,” he said.

According to Dr. Desai, there are three kinds of vitiligo. Active/unstable vitiligo is marked by depigmentation spreading across 1%-2% of body surface area per month, the size of about one to two palms. Refractory vitiligo responds poorly to therapy with less than 25% of affected areas experiencing repigmentation. And the third type is chronic vitiligo. “The majority of patients we see are in this phase, where depigmentation is present for at least 1 year with no history of spontaneous repigmentation.”

Before turning to therapy, he said, make sure to understand what the patient wants. “Are they even interested in being treated? I’ve had some patients with vitiligo, it’s only on their chest, and they’re always covered. They don’t even want anything. Then I have other patients who only want their face and hands treated because those are the only parts of their body that are exposed.”

To stabilize vitiligo, Dr. Desai recommends treating patients with “mini-pulse” oral therapy with systemic steroids. “I prescribe 4 milligrams of dexamethasone to be taken 2 consecutive days per week, such as Saturdays and Sundays. I usually halve the dose in children aged less than 16 years of age, so they’d be taking 2 milligrams.” Make sure, he said, to counsel patients on side effects.

He also recommends antioxidants, particularly polypodium leucotomos, “which has been shown in studies to increase the rates of head and neck repigmentation when combined with narrowband UVB.” He recommends 240 milligrams or higher, 2 or 3 times a day. He adds that alpha lipoic acid – in combination with vitamin C, vitamin E, and phototherapy – has also been shown to be effective in inducing repigmentation, especially on the head and neck.

As for newer drugs, Dr. Desai said afamelanotide, an analogue of alpha melanocyte-stimulating hormone combined with phototherapy, has shown promise. (It was approved in 2019 to increase pain free light exposure in adults with a history of phototoxic reactions related to erythropoietic protoporphyria.) Like other medications he mentioned, it isn’t FDA approved for treating vitiligo.

On another front, “Janus kinase inhibitors are our new frontier in treating vitiligo,” he said. “Tofacitinib can be dosed as an off-label usage in vitiligo in doses of 5 milligrams every other day, up to 5 milligrams daily. It’s half of the dose of rheumatoid arthritis, which is 5 milligrams b.i.d. You can actually start to see repigmentation as soon as 2 months, and then improvement up to 5 months.”

The drug requires laboratory monitoring and is expensive, he said, and JAK inhibitor side effects must be discussed with all patients.

Topical JAK inhibitors – tofacitinib 2% cream and ruxolitinib 1.5% cream – are also being evaluated as treatment for vitiligo. “I find that ruxolitinib works a little bit better, and the early bit of vitiligo data has shown that it tends to have more of a robust pigmentation response compared to tofacitinib,” said Dr. Desai, who gets these drugs compounded for topical use.

Dr. Desai added that he prefers to combine JAK inhibitors with phototherapy when possible.

For resistant vitiligo, he said, “lasers can help, especially Q-switched ruby and Q-switched Alexandrite laser. Q-switched Nd:Yag is very popular in Asia.”

In the big picture, he said, patients can benefit greatly from treatment. “Just think about the psychological improvement a patient would get by not having to get stares when walking in a mall and not having to deal with vitiligo lesions all over their cheek and neck.”

Dr. Desai disclosed performing clinical trials and/or consulting for numerous companies, including Pfizer, Allergan, AbbVie, and Dr. Reddy’s, among others. MedscapeLive and this news organization are owned by the same parent company.

Despite the lack of any Food and Drug Administration–approved medications for vitiligo, there are plenty of treatment options, and therapy can make a big difference in an individual’s quality of life, according to Seemal Desai, MD, of the University of Texas, Dallas.

“We have topical steroids. We have vitamin D analogs, calcineurin inhibitors, and depigmentation therapy. We also have systemic therapy, phototherapy, surgical treatment, and even psychological therapy, Dr. Desai said in a presentation at MedscapeLive’s virtual Women’s & Pediatric Dermatology Seminar.

Head and neck vitiligo, which “tends to respond very nicely to treatment,” is one of the affected areas “where we have an important obligation to make sure our patients are effectively and aggressively treated,” he said.

According to Dr. Desai, there are three kinds of vitiligo. Active/unstable vitiligo is marked by depigmentation spreading across 1%-2% of body surface area per month, the size of about one to two palms. Refractory vitiligo responds poorly to therapy with less than 25% of affected areas experiencing repigmentation. And the third type is chronic vitiligo. “The majority of patients we see are in this phase, where depigmentation is present for at least 1 year with no history of spontaneous repigmentation.”

Before turning to therapy, he said, make sure to understand what the patient wants. “Are they even interested in being treated? I’ve had some patients with vitiligo, it’s only on their chest, and they’re always covered. They don’t even want anything. Then I have other patients who only want their face and hands treated because those are the only parts of their body that are exposed.”

To stabilize vitiligo, Dr. Desai recommends treating patients with “mini-pulse” oral therapy with systemic steroids. “I prescribe 4 milligrams of dexamethasone to be taken 2 consecutive days per week, such as Saturdays and Sundays. I usually halve the dose in children aged less than 16 years of age, so they’d be taking 2 milligrams.” Make sure, he said, to counsel patients on side effects.

He also recommends antioxidants, particularly polypodium leucotomos, “which has been shown in studies to increase the rates of head and neck repigmentation when combined with narrowband UVB.” He recommends 240 milligrams or higher, 2 or 3 times a day. He adds that alpha lipoic acid – in combination with vitamin C, vitamin E, and phototherapy – has also been shown to be effective in inducing repigmentation, especially on the head and neck.

As for newer drugs, Dr. Desai said afamelanotide, an analogue of alpha melanocyte-stimulating hormone combined with phototherapy, has shown promise. (It was approved in 2019 to increase pain free light exposure in adults with a history of phototoxic reactions related to erythropoietic protoporphyria.) Like other medications he mentioned, it isn’t FDA approved for treating vitiligo.

On another front, “Janus kinase inhibitors are our new frontier in treating vitiligo,” he said. “Tofacitinib can be dosed as an off-label usage in vitiligo in doses of 5 milligrams every other day, up to 5 milligrams daily. It’s half of the dose of rheumatoid arthritis, which is 5 milligrams b.i.d. You can actually start to see repigmentation as soon as 2 months, and then improvement up to 5 months.”

The drug requires laboratory monitoring and is expensive, he said, and JAK inhibitor side effects must be discussed with all patients.

Topical JAK inhibitors – tofacitinib 2% cream and ruxolitinib 1.5% cream – are also being evaluated as treatment for vitiligo. “I find that ruxolitinib works a little bit better, and the early bit of vitiligo data has shown that it tends to have more of a robust pigmentation response compared to tofacitinib,” said Dr. Desai, who gets these drugs compounded for topical use.

Dr. Desai added that he prefers to combine JAK inhibitors with phototherapy when possible.

For resistant vitiligo, he said, “lasers can help, especially Q-switched ruby and Q-switched Alexandrite laser. Q-switched Nd:Yag is very popular in Asia.”

In the big picture, he said, patients can benefit greatly from treatment. “Just think about the psychological improvement a patient would get by not having to get stares when walking in a mall and not having to deal with vitiligo lesions all over their cheek and neck.”

Dr. Desai disclosed performing clinical trials and/or consulting for numerous companies, including Pfizer, Allergan, AbbVie, and Dr. Reddy’s, among others. MedscapeLive and this news organization are owned by the same parent company.

Despite the lack of any Food and Drug Administration–approved medications for vitiligo, there are plenty of treatment options, and therapy can make a big difference in an individual’s quality of life, according to Seemal Desai, MD, of the University of Texas, Dallas.

“We have topical steroids. We have vitamin D analogs, calcineurin inhibitors, and depigmentation therapy. We also have systemic therapy, phototherapy, surgical treatment, and even psychological therapy, Dr. Desai said in a presentation at MedscapeLive’s virtual Women’s & Pediatric Dermatology Seminar.

Head and neck vitiligo, which “tends to respond very nicely to treatment,” is one of the affected areas “where we have an important obligation to make sure our patients are effectively and aggressively treated,” he said.

According to Dr. Desai, there are three kinds of vitiligo. Active/unstable vitiligo is marked by depigmentation spreading across 1%-2% of body surface area per month, the size of about one to two palms. Refractory vitiligo responds poorly to therapy with less than 25% of affected areas experiencing repigmentation. And the third type is chronic vitiligo. “The majority of patients we see are in this phase, where depigmentation is present for at least 1 year with no history of spontaneous repigmentation.”

Before turning to therapy, he said, make sure to understand what the patient wants. “Are they even interested in being treated? I’ve had some patients with vitiligo, it’s only on their chest, and they’re always covered. They don’t even want anything. Then I have other patients who only want their face and hands treated because those are the only parts of their body that are exposed.”

To stabilize vitiligo, Dr. Desai recommends treating patients with “mini-pulse” oral therapy with systemic steroids. “I prescribe 4 milligrams of dexamethasone to be taken 2 consecutive days per week, such as Saturdays and Sundays. I usually halve the dose in children aged less than 16 years of age, so they’d be taking 2 milligrams.” Make sure, he said, to counsel patients on side effects.

He also recommends antioxidants, particularly polypodium leucotomos, “which has been shown in studies to increase the rates of head and neck repigmentation when combined with narrowband UVB.” He recommends 240 milligrams or higher, 2 or 3 times a day. He adds that alpha lipoic acid – in combination with vitamin C, vitamin E, and phototherapy – has also been shown to be effective in inducing repigmentation, especially on the head and neck.

As for newer drugs, Dr. Desai said afamelanotide, an analogue of alpha melanocyte-stimulating hormone combined with phototherapy, has shown promise. (It was approved in 2019 to increase pain free light exposure in adults with a history of phototoxic reactions related to erythropoietic protoporphyria.) Like other medications he mentioned, it isn’t FDA approved for treating vitiligo.

On another front, “Janus kinase inhibitors are our new frontier in treating vitiligo,” he said. “Tofacitinib can be dosed as an off-label usage in vitiligo in doses of 5 milligrams every other day, up to 5 milligrams daily. It’s half of the dose of rheumatoid arthritis, which is 5 milligrams b.i.d. You can actually start to see repigmentation as soon as 2 months, and then improvement up to 5 months.”

The drug requires laboratory monitoring and is expensive, he said, and JAK inhibitor side effects must be discussed with all patients.

Topical JAK inhibitors – tofacitinib 2% cream and ruxolitinib 1.5% cream – are also being evaluated as treatment for vitiligo. “I find that ruxolitinib works a little bit better, and the early bit of vitiligo data has shown that it tends to have more of a robust pigmentation response compared to tofacitinib,” said Dr. Desai, who gets these drugs compounded for topical use.

Dr. Desai added that he prefers to combine JAK inhibitors with phototherapy when possible.

For resistant vitiligo, he said, “lasers can help, especially Q-switched ruby and Q-switched Alexandrite laser. Q-switched Nd:Yag is very popular in Asia.”

In the big picture, he said, patients can benefit greatly from treatment. “Just think about the psychological improvement a patient would get by not having to get stares when walking in a mall and not having to deal with vitiligo lesions all over their cheek and neck.”

Dr. Desai disclosed performing clinical trials and/or consulting for numerous companies, including Pfizer, Allergan, AbbVie, and Dr. Reddy’s, among others. MedscapeLive and this news organization are owned by the same parent company.

About 20% of gestational carriers at one institution did not meet recommended criteria developed by the American Society for Reproductive Medicine, according to a retrospective study of 194 patients.

The University of California, San Francisco, offers additional, stricter recommendations, including that gestational carriers have a body mass index less than 35. Under these stricter criteria, about 30% of the gestational carriers did not meet recommendations, Brett Stark, MD, MPH, reported at the American Society for Reproductive Medicine’s 2020 annual meeting, held virtually this year.

Deviating from BMI or age recommendations may be associated with increased likelihood of spontaneous abortion, the analysis suggested. In addition, elements of a gestational carrier’s obstetric history not described in current guidelines, such as prior preterm birth, may influence gestational surrogacy outcomes.

The study was limited by incomplete information for some patients, the retrospective design, and the reliance on a relatively small cohort at a single center. Nevertheless, the findings potentially could inform discussions with patients, said Dr. Stark, a 3rd-year obstetrics and gynecology resident at the university.

Investigators aim to enroll patients in a longitudinal cohort study to further examine these questions, he said.

Protecting intended parents and carriers

“Gestational surrogacy has become an increasingly common form of third-party reproduction,” Dr. Stark said at the virtual meeting. The number of cases of in vitro fertilization (IVF) with gestational carriers increased from approximately 700 in 1999 to more than 5,500 in 2016, according to data from the Society for Assisted Reproductive Technology. “Despite the increasing prevalence of gestational carrier utilization, there remains limited guidance with regard to optimizing outcomes for both the intended parents and gestational carriers.”

ASRM and UCSF recommendations are based on expert opinion and include surprisingly little discussion about the prior pregnancy outcomes of potential gestational carriers, Dr. Stark said.

“It is important for all parties involved that we generate research and data that can help drive the development of the guidelines,” he said. Such evidence may help intended parents understand characteristics of gestational carriers that may lead to live births. “For the gestational carriers, it is important that we have information on safety so that they know they are making appropriate decisions for their family and their life.”

Gestational carrier characteristics in the present study that deviated from 2017 ASRM recommendations included age less than 21 years or greater than 45 years, mental health conditions, and having more than five prior deliveries.

“ASRM guidelines focused on criteria for gestational carriers are meant to protect infertile couples, the carrier, as well as the supporting agency,” Alan Penzias, MD, chair of ASRM’s Practice Committee who is in private practice in Boston, said in a society news release that highlighted Dr. Stark’s study. “It is important that gestational carriers have a complete medical history and examination, in addition to a psychological session with a mental health professional to ensure there are no reasons for the carrier to not move forward with pregnancy.”

A retrospective study by Kate Swanson, MD, and associates found that nonadherence to ASRM guidelines was associated with increased rates of cesarean delivery, neonatal morbidity, and preterm birth.

To examine how adherence to ASRM and UCSF recommendations relates to pregnancy outcomes and maternal and neonatal morbidity and death, Dr. Stark and colleagues assessed births from gestational carrier pregnancies at UCSF between 2008 and 2019.

Of 194 gestational carriers included in the analysis, 98.9% had a prior term pregnancy, 11.9% had a prior preterm pregnancy, and 17.5% had a prior spontaneous abortion.

Indications for use of gestational surrogates included serious medical condition of intended parent (25%), uterine factor infertility (23%), recurrent pregnancy loss (10%), and same-sex male couples (8%).

When the researchers compared pregnancy outcomes for gestational carriers who met ASRM guidelines with outcomes for 38 gestational carriers who did not meet ASRM guidelines, there were no statistically significant differences. Antepartum, intrapartum, and postpartum complication rates and cesarean delivery rates did not significantly differ based on ASRM guideline adherence.

Nonadherence to the stricter UCSF guidelines, however, was associated with increased likelihood of spontaneous abortion. In all, 23.7% of the 59 gestational carriers who were nonadherent to UCSF guidelines had a pregnancy end in a spontaneous abortion, compared with 6.7% of gestational carriers who were adherent to the UCSF recommendations (odds ratio, 4.35).

An analysis of individual criteria and poor pregnancy outcomes found that BMI greater than 35 was associated with increased likelihood of spontaneous abortion (OR, 4.29), as was age less than 21 years or greater than 45 years (OR, 3.37).

Prior spontaneous abortion was associated with increased likelihood of a biochemical pregnancy (OR, 3.2), and prior preterm birth was associated with increased likelihood of spontaneous abortion (OR, 3.19), previable delivery (OR, 25.2), cesarean delivery (OR, 2.59), and antepartum complications (OR, 3.56).
 

The role of agencies

About 76% of the gestational carriers had pregnancies mediated through a gestational surrogacy agency. Surrogates from agencies were about three times more likely than surrogates who were family, friends, or from private surrogacy arrangements to adhere to ASRM and UCSF guidelines.

Even after hearing about gestational carrier recommendations, patients may prefer to work with someone they know. “We want to provide our patients with evidence-based information if possible, but ultimately it is their decision to make,” Dr. Stark said. “And we just need to make sure that they are making an informed decision.”

Dr. Stark had no relevant disclosures. Dr. Penzias helped develop the ASRM committee opinion. He had no relevant conflicts of interest.

jremaly@mdedge.com

SOURCE: Stark B et al. ASRM 2020, Abstract O-251.

About 20% of gestational carriers at one institution did not meet recommended criteria developed by the American Society for Reproductive Medicine, according to a retrospective study of 194 patients.

The University of California, San Francisco, offers additional, stricter recommendations, including that gestational carriers have a body mass index less than 35. Under these stricter criteria, about 30% of the gestational carriers did not meet recommendations, Brett Stark, MD, MPH, reported at the American Society for Reproductive Medicine’s 2020 annual meeting, held virtually this year.

Deviating from BMI or age recommendations may be associated with increased likelihood of spontaneous abortion, the analysis suggested. In addition, elements of a gestational carrier’s obstetric history not described in current guidelines, such as prior preterm birth, may influence gestational surrogacy outcomes.

The study was limited by incomplete information for some patients, the retrospective design, and the reliance on a relatively small cohort at a single center. Nevertheless, the findings potentially could inform discussions with patients, said Dr. Stark, a 3rd-year obstetrics and gynecology resident at the university.

Investigators aim to enroll patients in a longitudinal cohort study to further examine these questions, he said.

Protecting intended parents and carriers

“Gestational surrogacy has become an increasingly common form of third-party reproduction,” Dr. Stark said at the virtual meeting. The number of cases of in vitro fertilization (IVF) with gestational carriers increased from approximately 700 in 1999 to more than 5,500 in 2016, according to data from the Society for Assisted Reproductive Technology. “Despite the increasing prevalence of gestational carrier utilization, there remains limited guidance with regard to optimizing outcomes for both the intended parents and gestational carriers.”

ASRM and UCSF recommendations are based on expert opinion and include surprisingly little discussion about the prior pregnancy outcomes of potential gestational carriers, Dr. Stark said.

“It is important for all parties involved that we generate research and data that can help drive the development of the guidelines,” he said. Such evidence may help intended parents understand characteristics of gestational carriers that may lead to live births. “For the gestational carriers, it is important that we have information on safety so that they know they are making appropriate decisions for their family and their life.”

Gestational carrier characteristics in the present study that deviated from 2017 ASRM recommendations included age less than 21 years or greater than 45 years, mental health conditions, and having more than five prior deliveries.

“ASRM guidelines focused on criteria for gestational carriers are meant to protect infertile couples, the carrier, as well as the supporting agency,” Alan Penzias, MD, chair of ASRM’s Practice Committee who is in private practice in Boston, said in a society news release that highlighted Dr. Stark’s study. “It is important that gestational carriers have a complete medical history and examination, in addition to a psychological session with a mental health professional to ensure there are no reasons for the carrier to not move forward with pregnancy.”

A retrospective study by Kate Swanson, MD, and associates found that nonadherence to ASRM guidelines was associated with increased rates of cesarean delivery, neonatal morbidity, and preterm birth.

To examine how adherence to ASRM and UCSF recommendations relates to pregnancy outcomes and maternal and neonatal morbidity and death, Dr. Stark and colleagues assessed births from gestational carrier pregnancies at UCSF between 2008 and 2019.

Of 194 gestational carriers included in the analysis, 98.9% had a prior term pregnancy, 11.9% had a prior preterm pregnancy, and 17.5% had a prior spontaneous abortion.

Indications for use of gestational surrogates included serious medical condition of intended parent (25%), uterine factor infertility (23%), recurrent pregnancy loss (10%), and same-sex male couples (8%).

When the researchers compared pregnancy outcomes for gestational carriers who met ASRM guidelines with outcomes for 38 gestational carriers who did not meet ASRM guidelines, there were no statistically significant differences. Antepartum, intrapartum, and postpartum complication rates and cesarean delivery rates did not significantly differ based on ASRM guideline adherence.

Nonadherence to the stricter UCSF guidelines, however, was associated with increased likelihood of spontaneous abortion. In all, 23.7% of the 59 gestational carriers who were nonadherent to UCSF guidelines had a pregnancy end in a spontaneous abortion, compared with 6.7% of gestational carriers who were adherent to the UCSF recommendations (odds ratio, 4.35).

An analysis of individual criteria and poor pregnancy outcomes found that BMI greater than 35 was associated with increased likelihood of spontaneous abortion (OR, 4.29), as was age less than 21 years or greater than 45 years (OR, 3.37).

Prior spontaneous abortion was associated with increased likelihood of a biochemical pregnancy (OR, 3.2), and prior preterm birth was associated with increased likelihood of spontaneous abortion (OR, 3.19), previable delivery (OR, 25.2), cesarean delivery (OR, 2.59), and antepartum complications (OR, 3.56).
 

The role of agencies

About 76% of the gestational carriers had pregnancies mediated through a gestational surrogacy agency. Surrogates from agencies were about three times more likely than surrogates who were family, friends, or from private surrogacy arrangements to adhere to ASRM and UCSF guidelines.

Even after hearing about gestational carrier recommendations, patients may prefer to work with someone they know. “We want to provide our patients with evidence-based information if possible, but ultimately it is their decision to make,” Dr. Stark said. “And we just need to make sure that they are making an informed decision.”

Dr. Stark had no relevant disclosures. Dr. Penzias helped develop the ASRM committee opinion. He had no relevant conflicts of interest.

jremaly@mdedge.com

SOURCE: Stark B et al. ASRM 2020, Abstract O-251.

About 20% of gestational carriers at one institution did not meet recommended criteria developed by the American Society for Reproductive Medicine, according to a retrospective study of 194 patients.

The University of California, San Francisco, offers additional, stricter recommendations, including that gestational carriers have a body mass index less than 35. Under these stricter criteria, about 30% of the gestational carriers did not meet recommendations, Brett Stark, MD, MPH, reported at the American Society for Reproductive Medicine’s 2020 annual meeting, held virtually this year.

Deviating from BMI or age recommendations may be associated with increased likelihood of spontaneous abortion, the analysis suggested. In addition, elements of a gestational carrier’s obstetric history not described in current guidelines, such as prior preterm birth, may influence gestational surrogacy outcomes.

The study was limited by incomplete information for some patients, the retrospective design, and the reliance on a relatively small cohort at a single center. Nevertheless, the findings potentially could inform discussions with patients, said Dr. Stark, a 3rd-year obstetrics and gynecology resident at the university.

Investigators aim to enroll patients in a longitudinal cohort study to further examine these questions, he said.

Protecting intended parents and carriers

“Gestational surrogacy has become an increasingly common form of third-party reproduction,” Dr. Stark said at the virtual meeting. The number of cases of in vitro fertilization (IVF) with gestational carriers increased from approximately 700 in 1999 to more than 5,500 in 2016, according to data from the Society for Assisted Reproductive Technology. “Despite the increasing prevalence of gestational carrier utilization, there remains limited guidance with regard to optimizing outcomes for both the intended parents and gestational carriers.”

ASRM and UCSF recommendations are based on expert opinion and include surprisingly little discussion about the prior pregnancy outcomes of potential gestational carriers, Dr. Stark said.

“It is important for all parties involved that we generate research and data that can help drive the development of the guidelines,” he said. Such evidence may help intended parents understand characteristics of gestational carriers that may lead to live births. “For the gestational carriers, it is important that we have information on safety so that they know they are making appropriate decisions for their family and their life.”

Gestational carrier characteristics in the present study that deviated from 2017 ASRM recommendations included age less than 21 years or greater than 45 years, mental health conditions, and having more than five prior deliveries.

“ASRM guidelines focused on criteria for gestational carriers are meant to protect infertile couples, the carrier, as well as the supporting agency,” Alan Penzias, MD, chair of ASRM’s Practice Committee who is in private practice in Boston, said in a society news release that highlighted Dr. Stark’s study. “It is important that gestational carriers have a complete medical history and examination, in addition to a psychological session with a mental health professional to ensure there are no reasons for the carrier to not move forward with pregnancy.”

A retrospective study by Kate Swanson, MD, and associates found that nonadherence to ASRM guidelines was associated with increased rates of cesarean delivery, neonatal morbidity, and preterm birth.

To examine how adherence to ASRM and UCSF recommendations relates to pregnancy outcomes and maternal and neonatal morbidity and death, Dr. Stark and colleagues assessed births from gestational carrier pregnancies at UCSF between 2008 and 2019.

Of 194 gestational carriers included in the analysis, 98.9% had a prior term pregnancy, 11.9% had a prior preterm pregnancy, and 17.5% had a prior spontaneous abortion.

Indications for use of gestational surrogates included serious medical condition of intended parent (25%), uterine factor infertility (23%), recurrent pregnancy loss (10%), and same-sex male couples (8%).

When the researchers compared pregnancy outcomes for gestational carriers who met ASRM guidelines with outcomes for 38 gestational carriers who did not meet ASRM guidelines, there were no statistically significant differences. Antepartum, intrapartum, and postpartum complication rates and cesarean delivery rates did not significantly differ based on ASRM guideline adherence.

Nonadherence to the stricter UCSF guidelines, however, was associated with increased likelihood of spontaneous abortion. In all, 23.7% of the 59 gestational carriers who were nonadherent to UCSF guidelines had a pregnancy end in a spontaneous abortion, compared with 6.7% of gestational carriers who were adherent to the UCSF recommendations (odds ratio, 4.35).

An analysis of individual criteria and poor pregnancy outcomes found that BMI greater than 35 was associated with increased likelihood of spontaneous abortion (OR, 4.29), as was age less than 21 years or greater than 45 years (OR, 3.37).

Prior spontaneous abortion was associated with increased likelihood of a biochemical pregnancy (OR, 3.2), and prior preterm birth was associated with increased likelihood of spontaneous abortion (OR, 3.19), previable delivery (OR, 25.2), cesarean delivery (OR, 2.59), and antepartum complications (OR, 3.56).
 

The role of agencies

About 76% of the gestational carriers had pregnancies mediated through a gestational surrogacy agency. Surrogates from agencies were about three times more likely than surrogates who were family, friends, or from private surrogacy arrangements to adhere to ASRM and UCSF guidelines.

Even after hearing about gestational carrier recommendations, patients may prefer to work with someone they know. “We want to provide our patients with evidence-based information if possible, but ultimately it is their decision to make,” Dr. Stark said. “And we just need to make sure that they are making an informed decision.”

Dr. Stark had no relevant disclosures. Dr. Penzias helped develop the ASRM committee opinion. He had no relevant conflicts of interest.

jremaly@mdedge.com

SOURCE: Stark B et al. ASRM 2020, Abstract O-251.

Physicians with difficult patient scenarios regularly bring their questions to the AGA Community to seek advice from colleagues about therapy and disease management options, best practices, and diagnoses. The upgraded networking platform now features a newsfeed for difficult patient scenarios and regularly scheduled Roundtable discussions with experts in the field.

In case you missed it, here are some clinical discussions and Roundtables in the newsfeed this month:

Which of the following patients needs a liver biopsy and why? (https://community.gastro.org/posts/23108)

Next steps for a Crohn’s patient (https://community.gastro.org/posts/23000)

Fecal calprotectin versus histology (https://community.gastro.org/posts/22969)

Collecting and sending specimen for disaccharidase assay (https://community.gastro.org/posts/23092)

Roundtables (https://community.gastro.org/discussions)
Q&A with CRC task force: Endoscopic Recognition and Management Strategies for Malignant Colorectal Polyps

View all upcoming Roundtables in the community at https://community.gastro.org/discussions.

Physicians with difficult patient scenarios regularly bring their questions to the AGA Community to seek advice from colleagues about therapy and disease management options, best practices, and diagnoses. The upgraded networking platform now features a newsfeed for difficult patient scenarios and regularly scheduled Roundtable discussions with experts in the field.

In case you missed it, here are some clinical discussions and Roundtables in the newsfeed this month:

Which of the following patients needs a liver biopsy and why? (https://community.gastro.org/posts/23108)

Next steps for a Crohn’s patient (https://community.gastro.org/posts/23000)

Fecal calprotectin versus histology (https://community.gastro.org/posts/22969)

Collecting and sending specimen for disaccharidase assay (https://community.gastro.org/posts/23092)

Roundtables (https://community.gastro.org/discussions)
Q&A with CRC task force: Endoscopic Recognition and Management Strategies for Malignant Colorectal Polyps

View all upcoming Roundtables in the community at https://community.gastro.org/discussions.

Physicians with difficult patient scenarios regularly bring their questions to the AGA Community to seek advice from colleagues about therapy and disease management options, best practices, and diagnoses. The upgraded networking platform now features a newsfeed for difficult patient scenarios and regularly scheduled Roundtable discussions with experts in the field.

In case you missed it, here are some clinical discussions and Roundtables in the newsfeed this month:

Which of the following patients needs a liver biopsy and why? (https://community.gastro.org/posts/23108)

Next steps for a Crohn’s patient (https://community.gastro.org/posts/23000)

Fecal calprotectin versus histology (https://community.gastro.org/posts/22969)

Collecting and sending specimen for disaccharidase assay (https://community.gastro.org/posts/23092)

Roundtables (https://community.gastro.org/discussions)
Q&A with CRC task force: Endoscopic Recognition and Management Strategies for Malignant Colorectal Polyps

View all upcoming Roundtables in the community at https://community.gastro.org/discussions.

With the publication or presentation of studies in 2020, there has been a significant expansion of treatment options for children with atopic dermatitis (AD) or psoriasis, Lawrence F. Eichenfield, MD, said at the annual Coastal Dermatology Symposium, held virtually.

Dr. Eichenfield, professor of dermatology and pediatrics, at the University of California, San Diego, presented a list of studies, some of which resulted in approvals of pediatric indications in 2020, that he believes deserve attention.
 

Crisaborole

Crisaborole ointment, 2% is now approved for topical treatment of children aged as young as 3 months, based on the results of the CrisADe CARE1 phase 4 study. In this open-label study of infants aged from 3 months to under 2 years with mild to moderate AD, treated with crisaborole twice a day for 28 days, the mean reduction from baseline in the Eczema Area and Severity Index (EASI) score was 49.6% on day 15 and 57.5% on day 29. The most common side effects were erythema and application-site pain, but neither occurred in more than 4% of patients. The discontinuation rate was less than 3%.

When the indication for treatment of young children down to age 3 months (from 24 months) was granted by the Food and Drug Administration in March 2020, crisaborole, a phosphodiesterase-4 inhibitor, became the only nonsteroidal approved for treatment of AD in children aged younger than 2 years, Dr. Eichenfield pointed out.
 

Tacrolimus

The topical calcineurin inhibitor tacrolimus (Protopic) poses no detectable risk of cancer in children treated for AD, according to a prospective, multinational study that followed nearly 8,000 children with AD who used topical tacrolimus for at least 6 weeks over 10 years. With 44,469 person-years of follow-up in a population with at least 6 weeks of exposure to tacrolimus, there were six confirmed cancers, a rate not different than background rates, and no lymphomas.

“I have always tried to educate my patients about the potential use of the topical calcineurin inhibitors while reassuring them that the data did not support significant risk,” Dr. Eichenfield said. However, a large set of data reconfirming a low risk of cancer, although not definitive, “are really nice to have.”
 

Ruxolitinib

For treatment of AD in children aged as young as 12 years, a cream formulation of ruxolitinib, a Janus kinase 1/JAK2 inhibitor, met its primary outcomes in the phase 3 TRuE AD1 and TRuE AD2 trials. (These data are not yet published but were presented at the Revolutionizing Atopic Dermatitis virtual symposium in April 2020.) The primary endpoint of 75% EASI clearance (EASI-75) was achieved in approximately 62% of patients treated with the 1.5% dose of ruxolitinib twice daily. This was a highly significant advantage over vehicle in both studies (P < .0001).

The EASI-75 rates at 8 weeks for the 0.75% formulation, at 56% and 51.5% for the TRuE AD1 and TRuE AD2 trials, respectively, were lower but also superior (P < .0001) to the 24.6% and 14.4% response rates on vehicle, respectively.

Emphasizing a consistent benefit on multiple secondary endpoints, including the “really early itch decrease,” Dr. Eichenfield described the phase 3 data as “really excellent results.” The data have not yet led to FDA approval of ruxolitinib for AD, but approval seems likely. Dr. Eichenfield noted that other drugs in the same class, such as abrocitinib and upadacitinib, have also demonstrated promising efficacy in children aged 12 years or older.
 

Dupilumab

Dupilumab, an interleukin-4 receptor alpha antagonist, was approved in May, 2020, for the treatment of AD in children ages 6-11 years, on the basis of a recently published phase 3, randomized, placebo-controlled trial that enrolled children aged between 6 and 11 years, comparing dupilumab and topical corticosteroids and placebo plus topical corticosteroids. Severe involvement was an entry criterion.

At 16 weeks, an EASI-75 response was achieved by 67% of the group randomized to 200 mg of dupilumab administered every 2 weeks and 70% of the group randomized to 300 mg every 4 weeks versus 27% of those randomized to placebo. More patients in the dupilumab arms developed conjunctivitis (10.8% vs. 4.7%) and had injection-site reactions (8.5% vs. 3.5%), but the monoclonal antibody was otherwise well tolerated and safe.

These data suggest that younger patients with severe disease “do, if anything, better than adults,” Dr. Eichenfield said at the meeting, jointly presented by the University of Louisville and Global Academy for Medical Education. He cautioned that avoiding live vaccines, which is recommended in patients on dupilumab, “is likely more of an issue in children.”

Ixekizumab

Ixekizumab has been approved for pediatric patients aged as young as 6 years who are eligible for systemic therapy on the basis of a phase 3 trial. For the primary endpoint of 75% clearance on the Psoriasis Area and Severity Index, the response rates were 89% for the IL-17 inhibitor administered every 4 weeks and 25% for placebo. The study also associated ixekizumab with a significant improvement in quality of life.

The availability of more targeted therapies for children are likely. In Europe, secukinumab, another IL-17 inhibitor, was approved for treatment in pediatric patients this past summer, Dr. Eichenfield noted. These data are not yet published, but he expects targeted therapies to join a growing list of biologics already approved in children.

For drugs with established efficacy and safety, he advised, “look at your pediatric psoriasis patients and don’t be wimpy.” In children with poorly controlled psoriasis, he concluded these drugs have been associated with improved quality of life.

In November 2019, the American Academy of Dermatology and National Psoriasis Foundation published psoriasis management guidelines for children. Not all of the most recently approved therapies are included in these guidelines, which are the first to provide specific recommendations for children, but Dr. Eichenfield also included this publication among his top picks for important contributions to the pediatric dermatology literature in 2020.

Dr. Eichenfield reported financial relationships with 20 pharmaceutical companies that manufacture dermatologic products, including those for the diseases he discussed.

This publication and Global Academy for Medical Education are owned by the same parent company.

With the publication or presentation of studies in 2020, there has been a significant expansion of treatment options for children with atopic dermatitis (AD) or psoriasis, Lawrence F. Eichenfield, MD, said at the annual Coastal Dermatology Symposium, held virtually.

Dr. Eichenfield, professor of dermatology and pediatrics, at the University of California, San Diego, presented a list of studies, some of which resulted in approvals of pediatric indications in 2020, that he believes deserve attention.
 

Crisaborole

Crisaborole ointment, 2% is now approved for topical treatment of children aged as young as 3 months, based on the results of the CrisADe CARE1 phase 4 study. In this open-label study of infants aged from 3 months to under 2 years with mild to moderate AD, treated with crisaborole twice a day for 28 days, the mean reduction from baseline in the Eczema Area and Severity Index (EASI) score was 49.6% on day 15 and 57.5% on day 29. The most common side effects were erythema and application-site pain, but neither occurred in more than 4% of patients. The discontinuation rate was less than 3%.

When the indication for treatment of young children down to age 3 months (from 24 months) was granted by the Food and Drug Administration in March 2020, crisaborole, a phosphodiesterase-4 inhibitor, became the only nonsteroidal approved for treatment of AD in children aged younger than 2 years, Dr. Eichenfield pointed out.
 

Tacrolimus

The topical calcineurin inhibitor tacrolimus (Protopic) poses no detectable risk of cancer in children treated for AD, according to a prospective, multinational study that followed nearly 8,000 children with AD who used topical tacrolimus for at least 6 weeks over 10 years. With 44,469 person-years of follow-up in a population with at least 6 weeks of exposure to tacrolimus, there were six confirmed cancers, a rate not different than background rates, and no lymphomas.

“I have always tried to educate my patients about the potential use of the topical calcineurin inhibitors while reassuring them that the data did not support significant risk,” Dr. Eichenfield said. However, a large set of data reconfirming a low risk of cancer, although not definitive, “are really nice to have.”
 

Ruxolitinib

For treatment of AD in children aged as young as 12 years, a cream formulation of ruxolitinib, a Janus kinase 1/JAK2 inhibitor, met its primary outcomes in the phase 3 TRuE AD1 and TRuE AD2 trials. (These data are not yet published but were presented at the Revolutionizing Atopic Dermatitis virtual symposium in April 2020.) The primary endpoint of 75% EASI clearance (EASI-75) was achieved in approximately 62% of patients treated with the 1.5% dose of ruxolitinib twice daily. This was a highly significant advantage over vehicle in both studies (P < .0001).

The EASI-75 rates at 8 weeks for the 0.75% formulation, at 56% and 51.5% for the TRuE AD1 and TRuE AD2 trials, respectively, were lower but also superior (P < .0001) to the 24.6% and 14.4% response rates on vehicle, respectively.

Emphasizing a consistent benefit on multiple secondary endpoints, including the “really early itch decrease,” Dr. Eichenfield described the phase 3 data as “really excellent results.” The data have not yet led to FDA approval of ruxolitinib for AD, but approval seems likely. Dr. Eichenfield noted that other drugs in the same class, such as abrocitinib and upadacitinib, have also demonstrated promising efficacy in children aged 12 years or older.
 

Dupilumab

Dupilumab, an interleukin-4 receptor alpha antagonist, was approved in May, 2020, for the treatment of AD in children ages 6-11 years, on the basis of a recently published phase 3, randomized, placebo-controlled trial that enrolled children aged between 6 and 11 years, comparing dupilumab and topical corticosteroids and placebo plus topical corticosteroids. Severe involvement was an entry criterion.

At 16 weeks, an EASI-75 response was achieved by 67% of the group randomized to 200 mg of dupilumab administered every 2 weeks and 70% of the group randomized to 300 mg every 4 weeks versus 27% of those randomized to placebo. More patients in the dupilumab arms developed conjunctivitis (10.8% vs. 4.7%) and had injection-site reactions (8.5% vs. 3.5%), but the monoclonal antibody was otherwise well tolerated and safe.

These data suggest that younger patients with severe disease “do, if anything, better than adults,” Dr. Eichenfield said at the meeting, jointly presented by the University of Louisville and Global Academy for Medical Education. He cautioned that avoiding live vaccines, which is recommended in patients on dupilumab, “is likely more of an issue in children.”

Ixekizumab

Ixekizumab has been approved for pediatric patients aged as young as 6 years who are eligible for systemic therapy on the basis of a phase 3 trial. For the primary endpoint of 75% clearance on the Psoriasis Area and Severity Index, the response rates were 89% for the IL-17 inhibitor administered every 4 weeks and 25% for placebo. The study also associated ixekizumab with a significant improvement in quality of life.

The availability of more targeted therapies for children are likely. In Europe, secukinumab, another IL-17 inhibitor, was approved for treatment in pediatric patients this past summer, Dr. Eichenfield noted. These data are not yet published, but he expects targeted therapies to join a growing list of biologics already approved in children.

For drugs with established efficacy and safety, he advised, “look at your pediatric psoriasis patients and don’t be wimpy.” In children with poorly controlled psoriasis, he concluded these drugs have been associated with improved quality of life.

In November 2019, the American Academy of Dermatology and National Psoriasis Foundation published psoriasis management guidelines for children. Not all of the most recently approved therapies are included in these guidelines, which are the first to provide specific recommendations for children, but Dr. Eichenfield also included this publication among his top picks for important contributions to the pediatric dermatology literature in 2020.

Dr. Eichenfield reported financial relationships with 20 pharmaceutical companies that manufacture dermatologic products, including those for the diseases he discussed.

This publication and Global Academy for Medical Education are owned by the same parent company.

With the publication or presentation of studies in 2020, there has been a significant expansion of treatment options for children with atopic dermatitis (AD) or psoriasis, Lawrence F. Eichenfield, MD, said at the annual Coastal Dermatology Symposium, held virtually.

Dr. Eichenfield, professor of dermatology and pediatrics, at the University of California, San Diego, presented a list of studies, some of which resulted in approvals of pediatric indications in 2020, that he believes deserve attention.
 

Crisaborole

Crisaborole ointment, 2% is now approved for topical treatment of children aged as young as 3 months, based on the results of the CrisADe CARE1 phase 4 study. In this open-label study of infants aged from 3 months to under 2 years with mild to moderate AD, treated with crisaborole twice a day for 28 days, the mean reduction from baseline in the Eczema Area and Severity Index (EASI) score was 49.6% on day 15 and 57.5% on day 29. The most common side effects were erythema and application-site pain, but neither occurred in more than 4% of patients. The discontinuation rate was less than 3%.

When the indication for treatment of young children down to age 3 months (from 24 months) was granted by the Food and Drug Administration in March 2020, crisaborole, a phosphodiesterase-4 inhibitor, became the only nonsteroidal approved for treatment of AD in children aged younger than 2 years, Dr. Eichenfield pointed out.
 

Tacrolimus

The topical calcineurin inhibitor tacrolimus (Protopic) poses no detectable risk of cancer in children treated for AD, according to a prospective, multinational study that followed nearly 8,000 children with AD who used topical tacrolimus for at least 6 weeks over 10 years. With 44,469 person-years of follow-up in a population with at least 6 weeks of exposure to tacrolimus, there were six confirmed cancers, a rate not different than background rates, and no lymphomas.

“I have always tried to educate my patients about the potential use of the topical calcineurin inhibitors while reassuring them that the data did not support significant risk,” Dr. Eichenfield said. However, a large set of data reconfirming a low risk of cancer, although not definitive, “are really nice to have.”
 

Ruxolitinib

For treatment of AD in children aged as young as 12 years, a cream formulation of ruxolitinib, a Janus kinase 1/JAK2 inhibitor, met its primary outcomes in the phase 3 TRuE AD1 and TRuE AD2 trials. (These data are not yet published but were presented at the Revolutionizing Atopic Dermatitis virtual symposium in April 2020.) The primary endpoint of 75% EASI clearance (EASI-75) was achieved in approximately 62% of patients treated with the 1.5% dose of ruxolitinib twice daily. This was a highly significant advantage over vehicle in both studies (P < .0001).

The EASI-75 rates at 8 weeks for the 0.75% formulation, at 56% and 51.5% for the TRuE AD1 and TRuE AD2 trials, respectively, were lower but also superior (P < .0001) to the 24.6% and 14.4% response rates on vehicle, respectively.

Emphasizing a consistent benefit on multiple secondary endpoints, including the “really early itch decrease,” Dr. Eichenfield described the phase 3 data as “really excellent results.” The data have not yet led to FDA approval of ruxolitinib for AD, but approval seems likely. Dr. Eichenfield noted that other drugs in the same class, such as abrocitinib and upadacitinib, have also demonstrated promising efficacy in children aged 12 years or older.
 

Dupilumab

Dupilumab, an interleukin-4 receptor alpha antagonist, was approved in May, 2020, for the treatment of AD in children ages 6-11 years, on the basis of a recently published phase 3, randomized, placebo-controlled trial that enrolled children aged between 6 and 11 years, comparing dupilumab and topical corticosteroids and placebo plus topical corticosteroids. Severe involvement was an entry criterion.

At 16 weeks, an EASI-75 response was achieved by 67% of the group randomized to 200 mg of dupilumab administered every 2 weeks and 70% of the group randomized to 300 mg every 4 weeks versus 27% of those randomized to placebo. More patients in the dupilumab arms developed conjunctivitis (10.8% vs. 4.7%) and had injection-site reactions (8.5% vs. 3.5%), but the monoclonal antibody was otherwise well tolerated and safe.

These data suggest that younger patients with severe disease “do, if anything, better than adults,” Dr. Eichenfield said at the meeting, jointly presented by the University of Louisville and Global Academy for Medical Education. He cautioned that avoiding live vaccines, which is recommended in patients on dupilumab, “is likely more of an issue in children.”

Ixekizumab

Ixekizumab has been approved for pediatric patients aged as young as 6 years who are eligible for systemic therapy on the basis of a phase 3 trial. For the primary endpoint of 75% clearance on the Psoriasis Area and Severity Index, the response rates were 89% for the IL-17 inhibitor administered every 4 weeks and 25% for placebo. The study also associated ixekizumab with a significant improvement in quality of life.

The availability of more targeted therapies for children are likely. In Europe, secukinumab, another IL-17 inhibitor, was approved for treatment in pediatric patients this past summer, Dr. Eichenfield noted. These data are not yet published, but he expects targeted therapies to join a growing list of biologics already approved in children.

For drugs with established efficacy and safety, he advised, “look at your pediatric psoriasis patients and don’t be wimpy.” In children with poorly controlled psoriasis, he concluded these drugs have been associated with improved quality of life.

In November 2019, the American Academy of Dermatology and National Psoriasis Foundation published psoriasis management guidelines for children. Not all of the most recently approved therapies are included in these guidelines, which are the first to provide specific recommendations for children, but Dr. Eichenfield also included this publication among his top picks for important contributions to the pediatric dermatology literature in 2020.

Dr. Eichenfield reported financial relationships with 20 pharmaceutical companies that manufacture dermatologic products, including those for the diseases he discussed.

This publication and Global Academy for Medical Education are owned by the same parent company.

Respiratory syncytial virus vaccine development has progressed rapidly in recent years, and there is hope that an efficacious vaccine soon may be approved.

Dr. Craig Lyerla/CDC

Louis Bont, MD, PhD, provided an overview of the most recent developments in the complex respiratory syncytial virus (RSV) vaccine landscape at the annual meeting of the European Society for Paediatric Infectious Diseases, held virtually this year.

RSV imposes significant burden worldwide, with 33 million patients, 3 million hospitalizations, and at least 120,000 deaths, reported Dr. Bont of the Wilhelmina Children’s Hospital, University Medical Centre, Utrecht, the Netherlands. Of those deaths, more than 50% are in infants younger than 5 months, and “about 99% of the children dying from RSV live in low- and middle-income countries.”

“There are high-risk populations, such as children with prematurity, congenital heart disease, lung disease, and Down syndrome, but about 73% of all children who are hospitalized for RSV infection were previously healthy children,” Dr. Bont explained. “So, we need to find a solution for all children to prevent RSV infection.”

As observed by Nienke Scheltema in a Lancet Global Health article, population distributions of RSV infection mortality show that, regardless of whether children have comorbidities or they are previously healthy, most children die at a very young age, Dr. Bont explained. These data suggest “that a maternal vaccine or an antibody prophylaxis approach from birth onwards or during the first RSV season is the solution for the problem.”

The path to developing an RSV vaccine has now narrowed its focus onto a structural element of RSV, the prefusion F protein. This shift started with the discovery by Jason McLellan (Science, 2013 [two papers]) that there are two variants of the RSV F-fusion protein: the very stable postfusion conformation and the prefusion active conformation, a metastable protein that exists for a “fraction of a second,” Dr. Bont said.

“The interesting thing is that epitopes that are visible at the prefusion, metastable state … induce highly neutralizing antibodies, whereas epitopes at the postfusion conformation do not,” Dr. Bont explained. “So, by stabilizing the prefusion state, we start inducing neutralizing antibodies that will protect against severe RSV infection, and this is the basic concept of all the vaccine developments currently ongoing.”

These RSV vaccine developments fall into five approach types: live-attenuated or chimeric vaccines, vector-based vaccines, monoclonal antibodies, particle-based vaccines, and subunit or protein-based vaccines.

One breakthrough, which was presented at last year’s ESPID meeting, is the monoclonal antibody nirsevimab. In addition to being nine times more potent than the broadly used antibody palivizumab, it is also more stable; whereas many antibodies have a half-life of 3 weeks, nirsevimab has a half-life of 100 days. “The idea is that a single injection at the start of the RSV season protects children in the first RSV season of their life, a dangerous episode for them.” Dr. Bont explained. The originators, AstraZeneca and Sanofi Pasteur, have “the vision that every child on this planet should receive a single injection with this antibody in the first season,” he explained.

Studies of nanoparticle-based maternal vaccines have also revealed interesting results: Although a phase 3 trial investigating such vaccines didn’t achieve its primary endpoint, “interestingly, 15% of all RSV infections were mild, and only 2% were very severe and leading to hypoxemia,” Dr. Bont noted. “But if we look at vaccine efficacy, we see the opposite – the vaccine was not very efficacious to prevent mild disease, but very efficacious to prevent severe hypoxemia; actually, this is exactly what you would like to see in a vaccine.”

Investigations into live-attenuated and vector-based vaccines have been promising as well, Dr. Bont shared. Studies of live-attenuated vaccines suggest they have a future and that we can move onto their next phase of clinical development, and a study investigating adenoviral vector-based vaccines has demonstrated safety, efficacy, and immunogenicity, though it has also shown that we should anticipate some side effects when using them.

Simple subunit vaccines for RSV are also being explored – a study of DS-Cav1, a stabilized prefusion F subunit protein candidate vaccine, has shown that it has a superior functional profile, compared with previous pre-F subunit vaccines. However, it seemed to be more efficacious against strains of RSV A than strains of RSV B, the dominant strain.

Dr. Bont also discussed exciting work by Sesterhenn et al., in which they used a computer-based program to develop their own vaccine. Using their in-depth knowledge of the RSV prefusion F protein and a computer program, Sesterhenn et al. developed a trivalent vaccine, produced it, and showed – both in vitro and in monkeys – that such vaccines can work up to the level of preclinical in vivo experiments.

“We can now make vaccines behind our computer,” Dr. Bont declared. “And the system doesn’t only work for RSV vaccines, but also for other pathogens – as long as you have an in-depth molecular knowledge of the target epitope,” he added.

Joanne Wildenbeest, MD, PhD, at the Utrecht University, the Netherlands commented: “Lower respiratory tract infections due to RSV are among the leading causes of death worldwide in children under the age of 5, especially young infants. The recent advances in the development of a vaccine and passive immunization are important steps towards the goal to reduce childhood mortality due to RSV worldwide. Since RSV-related mortality is mainly seen in developing countries it is important that, once a vaccine has been approved, it will also be made easily available to these countries.”

Dr. Bont reported the following disclosures: ReSViNET (a nonprofit foundation); investigator-initiated studies with the Bill & Melinda Gates Foundation, AbbVie, MedImmune, and MeMed; participation with Pfizer, Regeneron, and Janssen; and consultancy with GlaxoSmithKline, Ablynx, Novavax, and Janssen.

Respiratory syncytial virus vaccine development has progressed rapidly in recent years, and there is hope that an efficacious vaccine soon may be approved.

Dr. Craig Lyerla/CDC

Louis Bont, MD, PhD, provided an overview of the most recent developments in the complex respiratory syncytial virus (RSV) vaccine landscape at the annual meeting of the European Society for Paediatric Infectious Diseases, held virtually this year.

RSV imposes significant burden worldwide, with 33 million patients, 3 million hospitalizations, and at least 120,000 deaths, reported Dr. Bont of the Wilhelmina Children’s Hospital, University Medical Centre, Utrecht, the Netherlands. Of those deaths, more than 50% are in infants younger than 5 months, and “about 99% of the children dying from RSV live in low- and middle-income countries.”

“There are high-risk populations, such as children with prematurity, congenital heart disease, lung disease, and Down syndrome, but about 73% of all children who are hospitalized for RSV infection were previously healthy children,” Dr. Bont explained. “So, we need to find a solution for all children to prevent RSV infection.”

As observed by Nienke Scheltema in a Lancet Global Health article, population distributions of RSV infection mortality show that, regardless of whether children have comorbidities or they are previously healthy, most children die at a very young age, Dr. Bont explained. These data suggest “that a maternal vaccine or an antibody prophylaxis approach from birth onwards or during the first RSV season is the solution for the problem.”

The path to developing an RSV vaccine has now narrowed its focus onto a structural element of RSV, the prefusion F protein. This shift started with the discovery by Jason McLellan (Science, 2013 [two papers]) that there are two variants of the RSV F-fusion protein: the very stable postfusion conformation and the prefusion active conformation, a metastable protein that exists for a “fraction of a second,” Dr. Bont said.

“The interesting thing is that epitopes that are visible at the prefusion, metastable state … induce highly neutralizing antibodies, whereas epitopes at the postfusion conformation do not,” Dr. Bont explained. “So, by stabilizing the prefusion state, we start inducing neutralizing antibodies that will protect against severe RSV infection, and this is the basic concept of all the vaccine developments currently ongoing.”

These RSV vaccine developments fall into five approach types: live-attenuated or chimeric vaccines, vector-based vaccines, monoclonal antibodies, particle-based vaccines, and subunit or protein-based vaccines.

One breakthrough, which was presented at last year’s ESPID meeting, is the monoclonal antibody nirsevimab. In addition to being nine times more potent than the broadly used antibody palivizumab, it is also more stable; whereas many antibodies have a half-life of 3 weeks, nirsevimab has a half-life of 100 days. “The idea is that a single injection at the start of the RSV season protects children in the first RSV season of their life, a dangerous episode for them.” Dr. Bont explained. The originators, AstraZeneca and Sanofi Pasteur, have “the vision that every child on this planet should receive a single injection with this antibody in the first season,” he explained.

Studies of nanoparticle-based maternal vaccines have also revealed interesting results: Although a phase 3 trial investigating such vaccines didn’t achieve its primary endpoint, “interestingly, 15% of all RSV infections were mild, and only 2% were very severe and leading to hypoxemia,” Dr. Bont noted. “But if we look at vaccine efficacy, we see the opposite – the vaccine was not very efficacious to prevent mild disease, but very efficacious to prevent severe hypoxemia; actually, this is exactly what you would like to see in a vaccine.”

Investigations into live-attenuated and vector-based vaccines have been promising as well, Dr. Bont shared. Studies of live-attenuated vaccines suggest they have a future and that we can move onto their next phase of clinical development, and a study investigating adenoviral vector-based vaccines has demonstrated safety, efficacy, and immunogenicity, though it has also shown that we should anticipate some side effects when using them.

Simple subunit vaccines for RSV are also being explored – a study of DS-Cav1, a stabilized prefusion F subunit protein candidate vaccine, has shown that it has a superior functional profile, compared with previous pre-F subunit vaccines. However, it seemed to be more efficacious against strains of RSV A than strains of RSV B, the dominant strain.

Dr. Bont also discussed exciting work by Sesterhenn et al., in which they used a computer-based program to develop their own vaccine. Using their in-depth knowledge of the RSV prefusion F protein and a computer program, Sesterhenn et al. developed a trivalent vaccine, produced it, and showed – both in vitro and in monkeys – that such vaccines can work up to the level of preclinical in vivo experiments.

“We can now make vaccines behind our computer,” Dr. Bont declared. “And the system doesn’t only work for RSV vaccines, but also for other pathogens – as long as you have an in-depth molecular knowledge of the target epitope,” he added.

Joanne Wildenbeest, MD, PhD, at the Utrecht University, the Netherlands commented: “Lower respiratory tract infections due to RSV are among the leading causes of death worldwide in children under the age of 5, especially young infants. The recent advances in the development of a vaccine and passive immunization are important steps towards the goal to reduce childhood mortality due to RSV worldwide. Since RSV-related mortality is mainly seen in developing countries it is important that, once a vaccine has been approved, it will also be made easily available to these countries.”

Dr. Bont reported the following disclosures: ReSViNET (a nonprofit foundation); investigator-initiated studies with the Bill & Melinda Gates Foundation, AbbVie, MedImmune, and MeMed; participation with Pfizer, Regeneron, and Janssen; and consultancy with GlaxoSmithKline, Ablynx, Novavax, and Janssen.

Respiratory syncytial virus vaccine development has progressed rapidly in recent years, and there is hope that an efficacious vaccine soon may be approved.

Dr. Craig Lyerla/CDC

Louis Bont, MD, PhD, provided an overview of the most recent developments in the complex respiratory syncytial virus (RSV) vaccine landscape at the annual meeting of the European Society for Paediatric Infectious Diseases, held virtually this year.

RSV imposes significant burden worldwide, with 33 million patients, 3 million hospitalizations, and at least 120,000 deaths, reported Dr. Bont of the Wilhelmina Children’s Hospital, University Medical Centre, Utrecht, the Netherlands. Of those deaths, more than 50% are in infants younger than 5 months, and “about 99% of the children dying from RSV live in low- and middle-income countries.”

“There are high-risk populations, such as children with prematurity, congenital heart disease, lung disease, and Down syndrome, but about 73% of all children who are hospitalized for RSV infection were previously healthy children,” Dr. Bont explained. “So, we need to find a solution for all children to prevent RSV infection.”

As observed by Nienke Scheltema in a Lancet Global Health article, population distributions of RSV infection mortality show that, regardless of whether children have comorbidities or they are previously healthy, most children die at a very young age, Dr. Bont explained. These data suggest “that a maternal vaccine or an antibody prophylaxis approach from birth onwards or during the first RSV season is the solution for the problem.”

The path to developing an RSV vaccine has now narrowed its focus onto a structural element of RSV, the prefusion F protein. This shift started with the discovery by Jason McLellan (Science, 2013 [two papers]) that there are two variants of the RSV F-fusion protein: the very stable postfusion conformation and the prefusion active conformation, a metastable protein that exists for a “fraction of a second,” Dr. Bont said.

“The interesting thing is that epitopes that are visible at the prefusion, metastable state … induce highly neutralizing antibodies, whereas epitopes at the postfusion conformation do not,” Dr. Bont explained. “So, by stabilizing the prefusion state, we start inducing neutralizing antibodies that will protect against severe RSV infection, and this is the basic concept of all the vaccine developments currently ongoing.”

These RSV vaccine developments fall into five approach types: live-attenuated or chimeric vaccines, vector-based vaccines, monoclonal antibodies, particle-based vaccines, and subunit or protein-based vaccines.

One breakthrough, which was presented at last year’s ESPID meeting, is the monoclonal antibody nirsevimab. In addition to being nine times more potent than the broadly used antibody palivizumab, it is also more stable; whereas many antibodies have a half-life of 3 weeks, nirsevimab has a half-life of 100 days. “The idea is that a single injection at the start of the RSV season protects children in the first RSV season of their life, a dangerous episode for them.” Dr. Bont explained. The originators, AstraZeneca and Sanofi Pasteur, have “the vision that every child on this planet should receive a single injection with this antibody in the first season,” he explained.

Studies of nanoparticle-based maternal vaccines have also revealed interesting results: Although a phase 3 trial investigating such vaccines didn’t achieve its primary endpoint, “interestingly, 15% of all RSV infections were mild, and only 2% were very severe and leading to hypoxemia,” Dr. Bont noted. “But if we look at vaccine efficacy, we see the opposite – the vaccine was not very efficacious to prevent mild disease, but very efficacious to prevent severe hypoxemia; actually, this is exactly what you would like to see in a vaccine.”

Investigations into live-attenuated and vector-based vaccines have been promising as well, Dr. Bont shared. Studies of live-attenuated vaccines suggest they have a future and that we can move onto their next phase of clinical development, and a study investigating adenoviral vector-based vaccines has demonstrated safety, efficacy, and immunogenicity, though it has also shown that we should anticipate some side effects when using them.

Simple subunit vaccines for RSV are also being explored – a study of DS-Cav1, a stabilized prefusion F subunit protein candidate vaccine, has shown that it has a superior functional profile, compared with previous pre-F subunit vaccines. However, it seemed to be more efficacious against strains of RSV A than strains of RSV B, the dominant strain.

Dr. Bont also discussed exciting work by Sesterhenn et al., in which they used a computer-based program to develop their own vaccine. Using their in-depth knowledge of the RSV prefusion F protein and a computer program, Sesterhenn et al. developed a trivalent vaccine, produced it, and showed – both in vitro and in monkeys – that such vaccines can work up to the level of preclinical in vivo experiments.

“We can now make vaccines behind our computer,” Dr. Bont declared. “And the system doesn’t only work for RSV vaccines, but also for other pathogens – as long as you have an in-depth molecular knowledge of the target epitope,” he added.

Joanne Wildenbeest, MD, PhD, at the Utrecht University, the Netherlands commented: “Lower respiratory tract infections due to RSV are among the leading causes of death worldwide in children under the age of 5, especially young infants. The recent advances in the development of a vaccine and passive immunization are important steps towards the goal to reduce childhood mortality due to RSV worldwide. Since RSV-related mortality is mainly seen in developing countries it is important that, once a vaccine has been approved, it will also be made easily available to these countries.”

Dr. Bont reported the following disclosures: ReSViNET (a nonprofit foundation); investigator-initiated studies with the Bill & Melinda Gates Foundation, AbbVie, MedImmune, and MeMed; participation with Pfizer, Regeneron, and Janssen; and consultancy with GlaxoSmithKline, Ablynx, Novavax, and Janssen.

The European PET-Boost trial finds that both of two strategies for delivering a radiation boost to locally advanced non–small cell lung cancer (NSCLC) tumors improve local control relative to that seen historically. Results were reported at the European Society for Radiology and Oncology 2020 Online Congress. 

“From previous studies, we know that local recurrences have an important negative impact on survival,” said presenting author Saskia A. Cooke, an MD, PhD candidate in the department of Radiation Oncology Research, the Netherlands Cancer Institute, Amsterdam.

In addition, research shows that, despite advances in drug therapy, the most common site of progression in this population is intrathoracic.

“These results further underline the need to develop treatment strategies which effectively prevent intrathoracic and local recurrences,” Ms. Cooke said.

PET-Boost is a multicenter, randomized trial that enrolled patients with inoperable stage II or III NSCLC and a primary tumor measuring 4 cm or greater.

“The study was a phase 2 ‘pick the winner’ trial, which, by design, does not compare the two arms to one another but to a historic rate of outcome,” Ms. Cooke explained.

The patients were randomized evenly to receive the standard 66 Gy of radiotherapy given in 24 fractions of 2.75 Gy with one of two dose-escalation strategies: a boost to the whole primary tumor or a boost to only the tumor area having high metabolic activity, with a maximum standard uptake value (SUVmax) of at least 50% on the pretreatment FDG-PET scan.

For each patient, both plans were created before randomization, with the dose escalated as high as possible up to an organ-at-risk constraint, Ms. Cooke noted.

“A key element is that the two plans were made isotoxic by equaling the mean lung dose, and in both arms, the dose was delivered integrated into the 24 fractions, so without prolongation of the overall treatment time,” she said.

The trial’s goal was to improve the 1-year rate of freedom from local failure from the 70% seen historically with conventional chemoradiotherapy to 85%.

The trial was stopped early because of slow accrual, after enrollment of 107 patients, Ms. Cooke reported. The large majority received concurrent or sequential chemotherapy with their radiotherapy.

With a median follow-up of 12.6 months for the endpoint, the 1-year rate of freedom from local failure as determined on centrally reviewed CT scans was 97% with the whole-tumor boost and 91% with the PET-directed boost. The 2-year rates were 89% and 82%, respectively.

With a median follow-up of 61 months for the endpoint, the 1-year rate of overall survival was 77% with the whole-tumor boost and 62% with the PET-directed boost. The 2-year rates were 46% and 43%, respectively.

The two boost strategies increased acute and late toxicity over that seen historically, but not to unacceptable levels, as reported previously (Radiother Oncol. 2019;131:166-73).

“In this PET-Boost trial, using hypofractionated personalized dose escalation led to a very good local control rate, which, in both arms, was more than 90% at 1 year,” Ms. Cooke summarized.

In fact, values compare favorably with those seen in the phase 3 RTOG 0617 trial using conventional chemoradiotherapy and dose escalation, even though patients in that trial had smaller tumors.

“Survival, especially in the group treated with the homogeneous boost, was actually similar to the RTOG 0617 high-dose arm and also quite similar to the 1-year survival in the placebo arm of the PACIFIC trial,” she added. The somewhat poorer survival at 2 years in PET-Boost was likely related, in part, to the large tumor volumes and the mediastinal radiation dose, she speculated.

The investigators are now evaluating specific sites of failure and extrathoracic recurrences, as well as assessing associations of toxicity with organ-at-risk doses and quality of life.

“While further results of the trial are awaited, so far, we do believe that in selected patients with locally advanced NSCLC, hypofractionated dose escalation to the tumor is a very important subject for future research,” Ms. Cooke said.

The investigators plan to carry the whole-tumor boost strategy forward because it yields similar efficacy but is easier to plan.

Not ready for prime time

“Overall, this study conceptually is well designed as it is forward thinking and uses imaging to personalize radiation treatment, going to higher doses to active areas of disease based on FDG-PET imaging,” Arya Amini, MD, assistant clinical professor in the department of radiation oncology, City of Hope Comprehensive Cancer Center, Duarte, Calif., said in an interview.

SOURCE: Lalezari F et al. ESTRO 2020. Abstract OC-0609.

The European PET-Boost trial finds that both of two strategies for delivering a radiation boost to locally advanced non–small cell lung cancer (NSCLC) tumors improve local control relative to that seen historically. Results were reported at the European Society for Radiology and Oncology 2020 Online Congress. 

“From previous studies, we know that local recurrences have an important negative impact on survival,” said presenting author Saskia A. Cooke, an MD, PhD candidate in the department of Radiation Oncology Research, the Netherlands Cancer Institute, Amsterdam.

In addition, research shows that, despite advances in drug therapy, the most common site of progression in this population is intrathoracic.

“These results further underline the need to develop treatment strategies which effectively prevent intrathoracic and local recurrences,” Ms. Cooke said.

PET-Boost is a multicenter, randomized trial that enrolled patients with inoperable stage II or III NSCLC and a primary tumor measuring 4 cm or greater.

“The study was a phase 2 ‘pick the winner’ trial, which, by design, does not compare the two arms to one another but to a historic rate of outcome,” Ms. Cooke explained.

The patients were randomized evenly to receive the standard 66 Gy of radiotherapy given in 24 fractions of 2.75 Gy with one of two dose-escalation strategies: a boost to the whole primary tumor or a boost to only the tumor area having high metabolic activity, with a maximum standard uptake value (SUVmax) of at least 50% on the pretreatment FDG-PET scan.

For each patient, both plans were created before randomization, with the dose escalated as high as possible up to an organ-at-risk constraint, Ms. Cooke noted.

“A key element is that the two plans were made isotoxic by equaling the mean lung dose, and in both arms, the dose was delivered integrated into the 24 fractions, so without prolongation of the overall treatment time,” she said.

The trial’s goal was to improve the 1-year rate of freedom from local failure from the 70% seen historically with conventional chemoradiotherapy to 85%.

The trial was stopped early because of slow accrual, after enrollment of 107 patients, Ms. Cooke reported. The large majority received concurrent or sequential chemotherapy with their radiotherapy.

With a median follow-up of 12.6 months for the endpoint, the 1-year rate of freedom from local failure as determined on centrally reviewed CT scans was 97% with the whole-tumor boost and 91% with the PET-directed boost. The 2-year rates were 89% and 82%, respectively.

With a median follow-up of 61 months for the endpoint, the 1-year rate of overall survival was 77% with the whole-tumor boost and 62% with the PET-directed boost. The 2-year rates were 46% and 43%, respectively.

The two boost strategies increased acute and late toxicity over that seen historically, but not to unacceptable levels, as reported previously (Radiother Oncol. 2019;131:166-73).

“In this PET-Boost trial, using hypofractionated personalized dose escalation led to a very good local control rate, which, in both arms, was more than 90% at 1 year,” Ms. Cooke summarized.

In fact, values compare favorably with those seen in the phase 3 RTOG 0617 trial using conventional chemoradiotherapy and dose escalation, even though patients in that trial had smaller tumors.

“Survival, especially in the group treated with the homogeneous boost, was actually similar to the RTOG 0617 high-dose arm and also quite similar to the 1-year survival in the placebo arm of the PACIFIC trial,” she added. The somewhat poorer survival at 2 years in PET-Boost was likely related, in part, to the large tumor volumes and the mediastinal radiation dose, she speculated.

The investigators are now evaluating specific sites of failure and extrathoracic recurrences, as well as assessing associations of toxicity with organ-at-risk doses and quality of life.

“While further results of the trial are awaited, so far, we do believe that in selected patients with locally advanced NSCLC, hypofractionated dose escalation to the tumor is a very important subject for future research,” Ms. Cooke said.

The investigators plan to carry the whole-tumor boost strategy forward because it yields similar efficacy but is easier to plan.

Not ready for prime time

“Overall, this study conceptually is well designed as it is forward thinking and uses imaging to personalize radiation treatment, going to higher doses to active areas of disease based on FDG-PET imaging,” Arya Amini, MD, assistant clinical professor in the department of radiation oncology, City of Hope Comprehensive Cancer Center, Duarte, Calif., said in an interview.

SOURCE: Lalezari F et al. ESTRO 2020. Abstract OC-0609.

The European PET-Boost trial finds that both of two strategies for delivering a radiation boost to locally advanced non–small cell lung cancer (NSCLC) tumors improve local control relative to that seen historically. Results were reported at the European Society for Radiology and Oncology 2020 Online Congress. 

“From previous studies, we know that local recurrences have an important negative impact on survival,” said presenting author Saskia A. Cooke, an MD, PhD candidate in the department of Radiation Oncology Research, the Netherlands Cancer Institute, Amsterdam.

In addition, research shows that, despite advances in drug therapy, the most common site of progression in this population is intrathoracic.

“These results further underline the need to develop treatment strategies which effectively prevent intrathoracic and local recurrences,” Ms. Cooke said.

PET-Boost is a multicenter, randomized trial that enrolled patients with inoperable stage II or III NSCLC and a primary tumor measuring 4 cm or greater.

“The study was a phase 2 ‘pick the winner’ trial, which, by design, does not compare the two arms to one another but to a historic rate of outcome,” Ms. Cooke explained.

The patients were randomized evenly to receive the standard 66 Gy of radiotherapy given in 24 fractions of 2.75 Gy with one of two dose-escalation strategies: a boost to the whole primary tumor or a boost to only the tumor area having high metabolic activity, with a maximum standard uptake value (SUVmax) of at least 50% on the pretreatment FDG-PET scan.

For each patient, both plans were created before randomization, with the dose escalated as high as possible up to an organ-at-risk constraint, Ms. Cooke noted.

“A key element is that the two plans were made isotoxic by equaling the mean lung dose, and in both arms, the dose was delivered integrated into the 24 fractions, so without prolongation of the overall treatment time,” she said.

The trial’s goal was to improve the 1-year rate of freedom from local failure from the 70% seen historically with conventional chemoradiotherapy to 85%.

The trial was stopped early because of slow accrual, after enrollment of 107 patients, Ms. Cooke reported. The large majority received concurrent or sequential chemotherapy with their radiotherapy.

With a median follow-up of 12.6 months for the endpoint, the 1-year rate of freedom from local failure as determined on centrally reviewed CT scans was 97% with the whole-tumor boost and 91% with the PET-directed boost. The 2-year rates were 89% and 82%, respectively.

With a median follow-up of 61 months for the endpoint, the 1-year rate of overall survival was 77% with the whole-tumor boost and 62% with the PET-directed boost. The 2-year rates were 46% and 43%, respectively.

The two boost strategies increased acute and late toxicity over that seen historically, but not to unacceptable levels, as reported previously (Radiother Oncol. 2019;131:166-73).

“In this PET-Boost trial, using hypofractionated personalized dose escalation led to a very good local control rate, which, in both arms, was more than 90% at 1 year,” Ms. Cooke summarized.

In fact, values compare favorably with those seen in the phase 3 RTOG 0617 trial using conventional chemoradiotherapy and dose escalation, even though patients in that trial had smaller tumors.

“Survival, especially in the group treated with the homogeneous boost, was actually similar to the RTOG 0617 high-dose arm and also quite similar to the 1-year survival in the placebo arm of the PACIFIC trial,” she added. The somewhat poorer survival at 2 years in PET-Boost was likely related, in part, to the large tumor volumes and the mediastinal radiation dose, she speculated.

The investigators are now evaluating specific sites of failure and extrathoracic recurrences, as well as assessing associations of toxicity with organ-at-risk doses and quality of life.

“While further results of the trial are awaited, so far, we do believe that in selected patients with locally advanced NSCLC, hypofractionated dose escalation to the tumor is a very important subject for future research,” Ms. Cooke said.

The investigators plan to carry the whole-tumor boost strategy forward because it yields similar efficacy but is easier to plan.

Not ready for prime time

“Overall, this study conceptually is well designed as it is forward thinking and uses imaging to personalize radiation treatment, going to higher doses to active areas of disease based on FDG-PET imaging,” Arya Amini, MD, assistant clinical professor in the department of radiation oncology, City of Hope Comprehensive Cancer Center, Duarte, Calif., said in an interview.

SOURCE: Lalezari F et al. ESTRO 2020. Abstract OC-0609.

Medicare officials stuck with their plan to increase payments for office visits for primary care and several other specialties that focus on helping patients manage complex conditions such as diabetes. In doing so, Medicare also finalized cuts for other fields, triggering a new wave of protests. While gastroenterology is estimated to experience a 4% cut, other fields are expecting cuts up to 10%.

The final version of the 2021 Medicare physician fee schedule was unveiled on the night of Dec. 1. The Centers for Medicare & Medicaid Services posted an unofficial copy of the rule, which will later be published in the Federal Register.

CMS said it completed work on this massive annual review of payments for clinicians later than it usually does because of the demands of the federal response to the COVID-19 pandemic. The 2021 physician fee rule takes effect on Jan. 1, 2021, within a 30-day period instead of the usual 60-day time frame.

The rule, which runs to more than 2,100 pages, makes myriad changes in Medicare policies, including rules on telehealth, and expands the roles of nurse practitioners and physician assistants.

The most contentious item proposed for 2021 was a reshuffling of payments among specialties as part of an overhaul of Medicare’s approach to valuing evaluation and management (E/M) services. There was broader support for other aspects of the E/M overhaul, which are intended to cut some of the administrative hassle clinicians face.

“This finalized policy marks the most significant updates to E/M codes in 30 years, reducing burden on doctors imposed by the coding system and rewarding time spent evaluating and managing their patients’ care,” CMS Administrator Seema Verma said in a statement. “In the past, the system has rewarded interventions and procedures over time spent with patients – time taken preventing disease and managing chronic illnesses.”

In the final rule, CMS summarized these results of the E/M changes in Table 106. CMS largely stuck with the approach outlined in a draft rule released in August, with minor changes in the amounts of cuts and increases.

Specialties in line for increases under the 2021 final physician fee schedule include allergy/immunology (9%), endocrinology (16%), family practice (13%), general practice (7%), geriatrics (3%), hematology/oncology (14%), internal medicine (4%), nephrology (6%), physician assistants (8%), psychiatry (7%), rheumatology (15%), and urology (8%).

In line for cuts would be anesthesiology (–8%), cardiac surgery (–8%), emergency medicine (–6%), general surgery (–6%), infectious disease (–4%), neurosurgery (–6%), physical/occupational therapy (–9%), plastic surgery (–7%), radiology (–10%), and thoracic surgery (–8%). The changes also would lead to an expected 4% decrease for gastroenterology. The GI societies are among the groups pressing Congress to intercede.

“Long overdue”

But there also are champions for the approach CMS took in the E/M overhaul. The influential Medicare Payment Advisory Commission (MedPAC) has argued strongly for keeping the budget-neutral approach to the E/M overhaul.

In an Oct. 2 comment to CMS about the draft 2021 physician fee schedule, MedPAC Chairman Michael E. Chernew, PhD, said this approach would “help rebalance the fee schedule from services that have become overvalued to services that have become undervalued.”

This budget-neutral approach also “will go further in reducing the large gap in compensation between primary care physicians (who had a median income of $243,000 in 2018) and specialists such as surgeons (whose median income was $426,000 in 2018),” Dr. Chernew wrote.

In a tweet, Robert B. Doherty, senior vice president of governmental affairs and public policy for the American College of Physicians, said CMS had “finalized long overdue payment increases for primary and comprehensive care including an add-in for more complex visits.”

The American Academy of Family Physicians joined ACP in a Nov. 30 letter to congressional leaders, urging them to allow Medicare “to increase investment in primary care, benefiting millions of Medicare patients and the program itself, and reject last-minute efforts to prevent these essential and long-overdue changes from going fully into effect on January 1, 2021.”

In the letter, AAFP and ACP and their cosigners argued for a need to address “underinvestment” in primary care by finalizing the E/M overhaul.

“Given that six in ten American adults have a chronic disease and four in ten have two or more chronic conditions, why would we, as a country, accept such an inadequate investment in the very care model that stands to provide maximum value to these patients?” they wrote. “Since we know that individuals with a longitudinal relationship with a primary care physician have better health outcomes and use fewer health care resources, why would we continue to direct money to higher-cost, marginal value services?”

Based on reporting from Medscape.com.

Medicare officials stuck with their plan to increase payments for office visits for primary care and several other specialties that focus on helping patients manage complex conditions such as diabetes. In doing so, Medicare also finalized cuts for other fields, triggering a new wave of protests. While gastroenterology is estimated to experience a 4% cut, other fields are expecting cuts up to 10%.

The final version of the 2021 Medicare physician fee schedule was unveiled on the night of Dec. 1. The Centers for Medicare & Medicaid Services posted an unofficial copy of the rule, which will later be published in the Federal Register.

CMS said it completed work on this massive annual review of payments for clinicians later than it usually does because of the demands of the federal response to the COVID-19 pandemic. The 2021 physician fee rule takes effect on Jan. 1, 2021, within a 30-day period instead of the usual 60-day time frame.

The rule, which runs to more than 2,100 pages, makes myriad changes in Medicare policies, including rules on telehealth, and expands the roles of nurse practitioners and physician assistants.

The most contentious item proposed for 2021 was a reshuffling of payments among specialties as part of an overhaul of Medicare’s approach to valuing evaluation and management (E/M) services. There was broader support for other aspects of the E/M overhaul, which are intended to cut some of the administrative hassle clinicians face.

“This finalized policy marks the most significant updates to E/M codes in 30 years, reducing burden on doctors imposed by the coding system and rewarding time spent evaluating and managing their patients’ care,” CMS Administrator Seema Verma said in a statement. “In the past, the system has rewarded interventions and procedures over time spent with patients – time taken preventing disease and managing chronic illnesses.”

In the final rule, CMS summarized these results of the E/M changes in Table 106. CMS largely stuck with the approach outlined in a draft rule released in August, with minor changes in the amounts of cuts and increases.

Specialties in line for increases under the 2021 final physician fee schedule include allergy/immunology (9%), endocrinology (16%), family practice (13%), general practice (7%), geriatrics (3%), hematology/oncology (14%), internal medicine (4%), nephrology (6%), physician assistants (8%), psychiatry (7%), rheumatology (15%), and urology (8%).

In line for cuts would be anesthesiology (–8%), cardiac surgery (–8%), emergency medicine (–6%), general surgery (–6%), infectious disease (–4%), neurosurgery (–6%), physical/occupational therapy (–9%), plastic surgery (–7%), radiology (–10%), and thoracic surgery (–8%). The changes also would lead to an expected 4% decrease for gastroenterology. The GI societies are among the groups pressing Congress to intercede.

“Long overdue”

But there also are champions for the approach CMS took in the E/M overhaul. The influential Medicare Payment Advisory Commission (MedPAC) has argued strongly for keeping the budget-neutral approach to the E/M overhaul.

In an Oct. 2 comment to CMS about the draft 2021 physician fee schedule, MedPAC Chairman Michael E. Chernew, PhD, said this approach would “help rebalance the fee schedule from services that have become overvalued to services that have become undervalued.”

This budget-neutral approach also “will go further in reducing the large gap in compensation between primary care physicians (who had a median income of $243,000 in 2018) and specialists such as surgeons (whose median income was $426,000 in 2018),” Dr. Chernew wrote.

In a tweet, Robert B. Doherty, senior vice president of governmental affairs and public policy for the American College of Physicians, said CMS had “finalized long overdue payment increases for primary and comprehensive care including an add-in for more complex visits.”

The American Academy of Family Physicians joined ACP in a Nov. 30 letter to congressional leaders, urging them to allow Medicare “to increase investment in primary care, benefiting millions of Medicare patients and the program itself, and reject last-minute efforts to prevent these essential and long-overdue changes from going fully into effect on January 1, 2021.”

In the letter, AAFP and ACP and their cosigners argued for a need to address “underinvestment” in primary care by finalizing the E/M overhaul.

“Given that six in ten American adults have a chronic disease and four in ten have two or more chronic conditions, why would we, as a country, accept such an inadequate investment in the very care model that stands to provide maximum value to these patients?” they wrote. “Since we know that individuals with a longitudinal relationship with a primary care physician have better health outcomes and use fewer health care resources, why would we continue to direct money to higher-cost, marginal value services?”

Based on reporting from Medscape.com.

Medicare officials stuck with their plan to increase payments for office visits for primary care and several other specialties that focus on helping patients manage complex conditions such as diabetes. In doing so, Medicare also finalized cuts for other fields, triggering a new wave of protests. While gastroenterology is estimated to experience a 4% cut, other fields are expecting cuts up to 10%.

The final version of the 2021 Medicare physician fee schedule was unveiled on the night of Dec. 1. The Centers for Medicare & Medicaid Services posted an unofficial copy of the rule, which will later be published in the Federal Register.

CMS said it completed work on this massive annual review of payments for clinicians later than it usually does because of the demands of the federal response to the COVID-19 pandemic. The 2021 physician fee rule takes effect on Jan. 1, 2021, within a 30-day period instead of the usual 60-day time frame.

The rule, which runs to more than 2,100 pages, makes myriad changes in Medicare policies, including rules on telehealth, and expands the roles of nurse practitioners and physician assistants.

The most contentious item proposed for 2021 was a reshuffling of payments among specialties as part of an overhaul of Medicare’s approach to valuing evaluation and management (E/M) services. There was broader support for other aspects of the E/M overhaul, which are intended to cut some of the administrative hassle clinicians face.

“This finalized policy marks the most significant updates to E/M codes in 30 years, reducing burden on doctors imposed by the coding system and rewarding time spent evaluating and managing their patients’ care,” CMS Administrator Seema Verma said in a statement. “In the past, the system has rewarded interventions and procedures over time spent with patients – time taken preventing disease and managing chronic illnesses.”

In the final rule, CMS summarized these results of the E/M changes in Table 106. CMS largely stuck with the approach outlined in a draft rule released in August, with minor changes in the amounts of cuts and increases.

Specialties in line for increases under the 2021 final physician fee schedule include allergy/immunology (9%), endocrinology (16%), family practice (13%), general practice (7%), geriatrics (3%), hematology/oncology (14%), internal medicine (4%), nephrology (6%), physician assistants (8%), psychiatry (7%), rheumatology (15%), and urology (8%).

In line for cuts would be anesthesiology (–8%), cardiac surgery (–8%), emergency medicine (–6%), general surgery (–6%), infectious disease (–4%), neurosurgery (–6%), physical/occupational therapy (–9%), plastic surgery (–7%), radiology (–10%), and thoracic surgery (–8%). The changes also would lead to an expected 4% decrease for gastroenterology. The GI societies are among the groups pressing Congress to intercede.

“Long overdue”

But there also are champions for the approach CMS took in the E/M overhaul. The influential Medicare Payment Advisory Commission (MedPAC) has argued strongly for keeping the budget-neutral approach to the E/M overhaul.

In an Oct. 2 comment to CMS about the draft 2021 physician fee schedule, MedPAC Chairman Michael E. Chernew, PhD, said this approach would “help rebalance the fee schedule from services that have become overvalued to services that have become undervalued.”

This budget-neutral approach also “will go further in reducing the large gap in compensation between primary care physicians (who had a median income of $243,000 in 2018) and specialists such as surgeons (whose median income was $426,000 in 2018),” Dr. Chernew wrote.

In a tweet, Robert B. Doherty, senior vice president of governmental affairs and public policy for the American College of Physicians, said CMS had “finalized long overdue payment increases for primary and comprehensive care including an add-in for more complex visits.”

The American Academy of Family Physicians joined ACP in a Nov. 30 letter to congressional leaders, urging them to allow Medicare “to increase investment in primary care, benefiting millions of Medicare patients and the program itself, and reject last-minute efforts to prevent these essential and long-overdue changes from going fully into effect on January 1, 2021.”

In the letter, AAFP and ACP and their cosigners argued for a need to address “underinvestment” in primary care by finalizing the E/M overhaul.

“Given that six in ten American adults have a chronic disease and four in ten have two or more chronic conditions, why would we, as a country, accept such an inadequate investment in the very care model that stands to provide maximum value to these patients?” they wrote. “Since we know that individuals with a longitudinal relationship with a primary care physician have better health outcomes and use fewer health care resources, why would we continue to direct money to higher-cost, marginal value services?”

Based on reporting from Medscape.com.

A diagnosis of atopic dermatitis in individuals ages 15 years or older, compared with controls without atopic dermatitis, was nearly twice as likely to be associated with autoimmune disease, in a case control study derived from Swedish national health care registry data.

Atopic dermatitis (AD) is known to be associated with other atopic conditions, and there is increasing evidence it is associated with some nonatopic conditions, including some cancers, cardiovascular disease, and neuropsychiatric disorders, according to Lina U. Ivert, MD, of the dermatology and venereology unit at the Karolinska Institutet, Stockholm, and coauthors. There are also some data indicating that autoimmune diseases, particularly those involving the skin and gastrointestinal tract, are more common in people with AD.

The aim of their study, published in the British Journal of Dermatology, was to investigate a wide spectrum of autoimmune diseases for associations with AD in a large-scale, population-based study using Swedish registers. Findings could lead to better monitoring of comorbidities and deeper understanding of disease burden and AD pathophysiology, they noted.
 

Large-scale study

With data from the Swedish Board of Health and Welfare’s National Patient Register on inpatient diagnoses since 1964 and specialist outpatient visits since 2001, the investigators included all patients aged 15 years and older with AD diagnoses (104,832) and matched them with controls from the general population (1,022,435). The authors noted that the large number of people included in the analysis allowed for robust estimates, and underscored that 80% of the AD patients included had received their diagnosis in a dermatology department, which reduces the risk of misclassification.

Association with autoimmune disease

The investigators found an association between AD and autoimmune disease, with an adjusted odds ratio) of 1.97 (95% confidence interval, 1.93-2.01). The association was present with several organ systems, particularly the skin and gastrointestinal tract, and with connective tissue diseases. The strongest associations with autoimmune skin diseases were found for dermatitis herpetiformis (aOR, 9.76; 95% CI, 8.10-11.8), alopecia areata (aOR, 5.11; 95% CI, 4.75-5.49), and chronic urticaria (aOR, 4.82; 95% CI, 4.48-5.19).

AD was associated with gastrointestinal diseases, including celiac disease (aOR, 1.96; 95% CI, 1.84-2.09), Crohn disease (aOR 1.83; CI, 1.71-1.96), and ulcerative colitis (aOR 1.58; 95% CI, 1.49-1.68).

Connective tissue diseases significantly associated with AD included systemic lupus erythematosus (aOR, 1.65; 95% CI, 1.42-1.90), ankylosing spondylitis (aOR, 1.46; 95% CI, 1.29-1.66), and RA (aOR, 1.44; 95% CI,1.34-1.54]). Hematologic or hepatic autoimmune disease associations with AD were not observed.
 

Stronger association with multiple diseases

The association between AD and two or more autoimmune diseases was significantly stronger than the association between AD and having one autoimmune disease. For example, the OR for AD among people with three to five autoimmune diseases was 3.33 (95% CI, 2.86-3.87), and was stronger in men (OR, 3.96; 95% CI, 2.92-5.37) than in women (OR, 3.14; 95% CI, 2.63-3.74).
 

Sex differences

In the study overall, the association with AD and autoimmune diseases was stronger in men (aOR, 2.18; 95% CI, 2.10-2.25), compared with women (aOR, 1.89; 95% CI, 1.85-1.93), but this “sex difference was only statistically significant between AD and RA and between AD and Celiac disease,” they noted.

Associations between AD and dermatomyositis, systemic scleroderma, systemic lupus erythematosus, Hashimoto’s disease, Graves disease, multiple sclerosis, and polymyalgia rheumatica were found only in women. Dr. Ivert and coauthors observed that “women are in general more likely to develop autoimmune diseases, and 80% of patients with autoimmune diseases are women.”
 

Provocative questions

Commenting on the findings, Jonathan Silverberg, MD, PhD, MPH, associate professor of dermatology, George Washington University, Washington, said, “At a high level, it is important for clinicians to recognize that atopic dermatitis is a systemic immune-mediated disease. AD is associated with higher rates of comorbid autoimmune disease, similar to psoriasis and other chronic inflammatory skin diseases.”

“At this point, there is nothing immediately actionable about these results,” noted Dr. Silverberg, who was not an author of this study. “That said, in my mind, they raise some provocative questions: What is the difference between AD in adults who do versus those who do not get comorbid autoimmune disease? Does AD then present differently? Does it respond to the same therapies? These will have to be the subject of future research.”

The study was funded by the Swedish Asthma and Allergy Association Research Foundation, Hudfonden (the Welander-Finsen Foundation), and the Swedish Society for Dermatology and Venereology. The authors disclosed no conflicts of interest.

SOURCE: Ivert LU et al. Br J Dermatol. 2020 Oct 22. doi: 10.1111/bjd.19624.

A diagnosis of atopic dermatitis in individuals ages 15 years or older, compared with controls without atopic dermatitis, was nearly twice as likely to be associated with autoimmune disease, in a case control study derived from Swedish national health care registry data.

Atopic dermatitis (AD) is known to be associated with other atopic conditions, and there is increasing evidence it is associated with some nonatopic conditions, including some cancers, cardiovascular disease, and neuropsychiatric disorders, according to Lina U. Ivert, MD, of the dermatology and venereology unit at the Karolinska Institutet, Stockholm, and coauthors. There are also some data indicating that autoimmune diseases, particularly those involving the skin and gastrointestinal tract, are more common in people with AD.

The aim of their study, published in the British Journal of Dermatology, was to investigate a wide spectrum of autoimmune diseases for associations with AD in a large-scale, population-based study using Swedish registers. Findings could lead to better monitoring of comorbidities and deeper understanding of disease burden and AD pathophysiology, they noted.
 

Large-scale study

With data from the Swedish Board of Health and Welfare’s National Patient Register on inpatient diagnoses since 1964 and specialist outpatient visits since 2001, the investigators included all patients aged 15 years and older with AD diagnoses (104,832) and matched them with controls from the general population (1,022,435). The authors noted that the large number of people included in the analysis allowed for robust estimates, and underscored that 80% of the AD patients included had received their diagnosis in a dermatology department, which reduces the risk of misclassification.

Association with autoimmune disease

The investigators found an association between AD and autoimmune disease, with an adjusted odds ratio) of 1.97 (95% confidence interval, 1.93-2.01). The association was present with several organ systems, particularly the skin and gastrointestinal tract, and with connective tissue diseases. The strongest associations with autoimmune skin diseases were found for dermatitis herpetiformis (aOR, 9.76; 95% CI, 8.10-11.8), alopecia areata (aOR, 5.11; 95% CI, 4.75-5.49), and chronic urticaria (aOR, 4.82; 95% CI, 4.48-5.19).

AD was associated with gastrointestinal diseases, including celiac disease (aOR, 1.96; 95% CI, 1.84-2.09), Crohn disease (aOR 1.83; CI, 1.71-1.96), and ulcerative colitis (aOR 1.58; 95% CI, 1.49-1.68).

Connective tissue diseases significantly associated with AD included systemic lupus erythematosus (aOR, 1.65; 95% CI, 1.42-1.90), ankylosing spondylitis (aOR, 1.46; 95% CI, 1.29-1.66), and RA (aOR, 1.44; 95% CI,1.34-1.54]). Hematologic or hepatic autoimmune disease associations with AD were not observed.
 

Stronger association with multiple diseases

The association between AD and two or more autoimmune diseases was significantly stronger than the association between AD and having one autoimmune disease. For example, the OR for AD among people with three to five autoimmune diseases was 3.33 (95% CI, 2.86-3.87), and was stronger in men (OR, 3.96; 95% CI, 2.92-5.37) than in women (OR, 3.14; 95% CI, 2.63-3.74).
 

Sex differences

In the study overall, the association with AD and autoimmune diseases was stronger in men (aOR, 2.18; 95% CI, 2.10-2.25), compared with women (aOR, 1.89; 95% CI, 1.85-1.93), but this “sex difference was only statistically significant between AD and RA and between AD and Celiac disease,” they noted.

Associations between AD and dermatomyositis, systemic scleroderma, systemic lupus erythematosus, Hashimoto’s disease, Graves disease, multiple sclerosis, and polymyalgia rheumatica were found only in women. Dr. Ivert and coauthors observed that “women are in general more likely to develop autoimmune diseases, and 80% of patients with autoimmune diseases are women.”
 

Provocative questions

Commenting on the findings, Jonathan Silverberg, MD, PhD, MPH, associate professor of dermatology, George Washington University, Washington, said, “At a high level, it is important for clinicians to recognize that atopic dermatitis is a systemic immune-mediated disease. AD is associated with higher rates of comorbid autoimmune disease, similar to psoriasis and other chronic inflammatory skin diseases.”

“At this point, there is nothing immediately actionable about these results,” noted Dr. Silverberg, who was not an author of this study. “That said, in my mind, they raise some provocative questions: What is the difference between AD in adults who do versus those who do not get comorbid autoimmune disease? Does AD then present differently? Does it respond to the same therapies? These will have to be the subject of future research.”

The study was funded by the Swedish Asthma and Allergy Association Research Foundation, Hudfonden (the Welander-Finsen Foundation), and the Swedish Society for Dermatology and Venereology. The authors disclosed no conflicts of interest.

SOURCE: Ivert LU et al. Br J Dermatol. 2020 Oct 22. doi: 10.1111/bjd.19624.

A diagnosis of atopic dermatitis in individuals ages 15 years or older, compared with controls without atopic dermatitis, was nearly twice as likely to be associated with autoimmune disease, in a case control study derived from Swedish national health care registry data.

Atopic dermatitis (AD) is known to be associated with other atopic conditions, and there is increasing evidence it is associated with some nonatopic conditions, including some cancers, cardiovascular disease, and neuropsychiatric disorders, according to Lina U. Ivert, MD, of the dermatology and venereology unit at the Karolinska Institutet, Stockholm, and coauthors. There are also some data indicating that autoimmune diseases, particularly those involving the skin and gastrointestinal tract, are more common in people with AD.

The aim of their study, published in the British Journal of Dermatology, was to investigate a wide spectrum of autoimmune diseases for associations with AD in a large-scale, population-based study using Swedish registers. Findings could lead to better monitoring of comorbidities and deeper understanding of disease burden and AD pathophysiology, they noted.
 

Large-scale study

With data from the Swedish Board of Health and Welfare’s National Patient Register on inpatient diagnoses since 1964 and specialist outpatient visits since 2001, the investigators included all patients aged 15 years and older with AD diagnoses (104,832) and matched them with controls from the general population (1,022,435). The authors noted that the large number of people included in the analysis allowed for robust estimates, and underscored that 80% of the AD patients included had received their diagnosis in a dermatology department, which reduces the risk of misclassification.

Association with autoimmune disease

The investigators found an association between AD and autoimmune disease, with an adjusted odds ratio) of 1.97 (95% confidence interval, 1.93-2.01). The association was present with several organ systems, particularly the skin and gastrointestinal tract, and with connective tissue diseases. The strongest associations with autoimmune skin diseases were found for dermatitis herpetiformis (aOR, 9.76; 95% CI, 8.10-11.8), alopecia areata (aOR, 5.11; 95% CI, 4.75-5.49), and chronic urticaria (aOR, 4.82; 95% CI, 4.48-5.19).

AD was associated with gastrointestinal diseases, including celiac disease (aOR, 1.96; 95% CI, 1.84-2.09), Crohn disease (aOR 1.83; CI, 1.71-1.96), and ulcerative colitis (aOR 1.58; 95% CI, 1.49-1.68).

Connective tissue diseases significantly associated with AD included systemic lupus erythematosus (aOR, 1.65; 95% CI, 1.42-1.90), ankylosing spondylitis (aOR, 1.46; 95% CI, 1.29-1.66), and RA (aOR, 1.44; 95% CI,1.34-1.54]). Hematologic or hepatic autoimmune disease associations with AD were not observed.
 

Stronger association with multiple diseases

The association between AD and two or more autoimmune diseases was significantly stronger than the association between AD and having one autoimmune disease. For example, the OR for AD among people with three to five autoimmune diseases was 3.33 (95% CI, 2.86-3.87), and was stronger in men (OR, 3.96; 95% CI, 2.92-5.37) than in women (OR, 3.14; 95% CI, 2.63-3.74).
 

Sex differences

In the study overall, the association with AD and autoimmune diseases was stronger in men (aOR, 2.18; 95% CI, 2.10-2.25), compared with women (aOR, 1.89; 95% CI, 1.85-1.93), but this “sex difference was only statistically significant between AD and RA and between AD and Celiac disease,” they noted.

Associations between AD and dermatomyositis, systemic scleroderma, systemic lupus erythematosus, Hashimoto’s disease, Graves disease, multiple sclerosis, and polymyalgia rheumatica were found only in women. Dr. Ivert and coauthors observed that “women are in general more likely to develop autoimmune diseases, and 80% of patients with autoimmune diseases are women.”
 

Provocative questions

Commenting on the findings, Jonathan Silverberg, MD, PhD, MPH, associate professor of dermatology, George Washington University, Washington, said, “At a high level, it is important for clinicians to recognize that atopic dermatitis is a systemic immune-mediated disease. AD is associated with higher rates of comorbid autoimmune disease, similar to psoriasis and other chronic inflammatory skin diseases.”

“At this point, there is nothing immediately actionable about these results,” noted Dr. Silverberg, who was not an author of this study. “That said, in my mind, they raise some provocative questions: What is the difference between AD in adults who do versus those who do not get comorbid autoimmune disease? Does AD then present differently? Does it respond to the same therapies? These will have to be the subject of future research.”

The study was funded by the Swedish Asthma and Allergy Association Research Foundation, Hudfonden (the Welander-Finsen Foundation), and the Swedish Society for Dermatology and Venereology. The authors disclosed no conflicts of interest.

SOURCE: Ivert LU et al. Br J Dermatol. 2020 Oct 22. doi: 10.1111/bjd.19624.