This article is brought you by AGA PAC, a voluntary, non-partisan political organization affiliated with and supported by AGA and the only political action committee supported by a national gastroenterology society. Its mission is to give gastroenterologists a greater presence on Capitol Hill and a more effective voice in policy discussions.

The 116th Congress is well represented by the physician community, featuring a total of 17 physicians: 3 in the U.S. Senate and 14 in the House of Representatives. One of the physicians in the House, Rep. Roger Marshall, MD, R-KS, is an OBGYN by trade who is currently serving his second term in Congress. First elected in 2016, he arrived in Washington as one of only two physicians in his freshman class. He actively engaged in health care policy from the very beginning, working across party lines on a range of health care issues facing Capitol Hill. Upon entering Congress, he proactively reached out to AGA as well as other specialty physician organizations to learn our priority issues and expressed his desire to serve as a champion of the physician community.

In addition to the two committees he sits on, Dr. Marshall also serves as the chairman of the health task force for the Republican Study Committee. Additionally, Dr. Marshall is a member of the GOP Doctors Caucus, a coalition of 21 Republican medical providers with a mission statement “to utilize medical expertise to develop patient-centered health care reforms focused on quality, access, affordability, portability, and choice.” The GOP Doctors Caucus was instrumental in pushing for a permanent repeal of the sustainable growth rate (SGR) and helped to coalesce bipartisan, bicameral support for repeal legislation in the 113th Congress. The GOP Doctors Caucus continues to be active in the current Congress, advocating for policies that strengthen both the patient and provider communities.

As a member of the GOP Doctors Caucus and as a physician held in high regard by his House colleagues, Dr. Marshall is uniquely situated to advance agendas and legislative priorities that promote sound health care policy. He willingly works across the aisle with his Democratic counterparts on legislation of importance to the physician and patient community. Dr. Marshall recently worked with one of his Democratic, physician colleagues, Rep. Ami Bera, MD, D-CA, on the Improving Seniors Timely Access to Care Act, legislation addressing prior authorization burdens in Medicare Advantage plans. Dr. Marshall has vocalized the importance of physicians getting involved in the political process and to that effect, spoke to AGA members at AGA’s annual Advocacy Day about his experience as a physician running for Congress and the importance of physician advocacy.

Dr. Marshall is running for the open Senate seat in Kansas. Given that Dr. Marshall has reiterated his desire to continue to work with the physician community to ensure access to care for our patients, AGA looks forward to supporting Dr. Marshall’s Senate candidacy and continuing to work with him and his office on issues and initiatives to advance the science and practice of gastroenterology.

[email protected]

This article is brought you by AGA PAC, a voluntary, non-partisan political organization affiliated with and supported by AGA and the only political action committee supported by a national gastroenterology society. Its mission is to give gastroenterologists a greater presence on Capitol Hill and a more effective voice in policy discussions.

The 116th Congress is well represented by the physician community, featuring a total of 17 physicians: 3 in the U.S. Senate and 14 in the House of Representatives. One of the physicians in the House, Rep. Roger Marshall, MD, R-KS, is an OBGYN by trade who is currently serving his second term in Congress. First elected in 2016, he arrived in Washington as one of only two physicians in his freshman class. He actively engaged in health care policy from the very beginning, working across party lines on a range of health care issues facing Capitol Hill. Upon entering Congress, he proactively reached out to AGA as well as other specialty physician organizations to learn our priority issues and expressed his desire to serve as a champion of the physician community.

In addition to the two committees he sits on, Dr. Marshall also serves as the chairman of the health task force for the Republican Study Committee. Additionally, Dr. Marshall is a member of the GOP Doctors Caucus, a coalition of 21 Republican medical providers with a mission statement “to utilize medical expertise to develop patient-centered health care reforms focused on quality, access, affordability, portability, and choice.” The GOP Doctors Caucus was instrumental in pushing for a permanent repeal of the sustainable growth rate (SGR) and helped to coalesce bipartisan, bicameral support for repeal legislation in the 113th Congress. The GOP Doctors Caucus continues to be active in the current Congress, advocating for policies that strengthen both the patient and provider communities.

As a member of the GOP Doctors Caucus and as a physician held in high regard by his House colleagues, Dr. Marshall is uniquely situated to advance agendas and legislative priorities that promote sound health care policy. He willingly works across the aisle with his Democratic counterparts on legislation of importance to the physician and patient community. Dr. Marshall recently worked with one of his Democratic, physician colleagues, Rep. Ami Bera, MD, D-CA, on the Improving Seniors Timely Access to Care Act, legislation addressing prior authorization burdens in Medicare Advantage plans. Dr. Marshall has vocalized the importance of physicians getting involved in the political process and to that effect, spoke to AGA members at AGA’s annual Advocacy Day about his experience as a physician running for Congress and the importance of physician advocacy.

Dr. Marshall is running for the open Senate seat in Kansas. Given that Dr. Marshall has reiterated his desire to continue to work with the physician community to ensure access to care for our patients, AGA looks forward to supporting Dr. Marshall’s Senate candidacy and continuing to work with him and his office on issues and initiatives to advance the science and practice of gastroenterology.

[email protected]

This article is brought you by AGA PAC, a voluntary, non-partisan political organization affiliated with and supported by AGA and the only political action committee supported by a national gastroenterology society. Its mission is to give gastroenterologists a greater presence on Capitol Hill and a more effective voice in policy discussions.

The 116th Congress is well represented by the physician community, featuring a total of 17 physicians: 3 in the U.S. Senate and 14 in the House of Representatives. One of the physicians in the House, Rep. Roger Marshall, MD, R-KS, is an OBGYN by trade who is currently serving his second term in Congress. First elected in 2016, he arrived in Washington as one of only two physicians in his freshman class. He actively engaged in health care policy from the very beginning, working across party lines on a range of health care issues facing Capitol Hill. Upon entering Congress, he proactively reached out to AGA as well as other specialty physician organizations to learn our priority issues and expressed his desire to serve as a champion of the physician community.

In addition to the two committees he sits on, Dr. Marshall also serves as the chairman of the health task force for the Republican Study Committee. Additionally, Dr. Marshall is a member of the GOP Doctors Caucus, a coalition of 21 Republican medical providers with a mission statement “to utilize medical expertise to develop patient-centered health care reforms focused on quality, access, affordability, portability, and choice.” The GOP Doctors Caucus was instrumental in pushing for a permanent repeal of the sustainable growth rate (SGR) and helped to coalesce bipartisan, bicameral support for repeal legislation in the 113th Congress. The GOP Doctors Caucus continues to be active in the current Congress, advocating for policies that strengthen both the patient and provider communities.

As a member of the GOP Doctors Caucus and as a physician held in high regard by his House colleagues, Dr. Marshall is uniquely situated to advance agendas and legislative priorities that promote sound health care policy. He willingly works across the aisle with his Democratic counterparts on legislation of importance to the physician and patient community. Dr. Marshall recently worked with one of his Democratic, physician colleagues, Rep. Ami Bera, MD, D-CA, on the Improving Seniors Timely Access to Care Act, legislation addressing prior authorization burdens in Medicare Advantage plans. Dr. Marshall has vocalized the importance of physicians getting involved in the political process and to that effect, spoke to AGA members at AGA’s annual Advocacy Day about his experience as a physician running for Congress and the importance of physician advocacy.

Dr. Marshall is running for the open Senate seat in Kansas. Given that Dr. Marshall has reiterated his desire to continue to work with the physician community to ensure access to care for our patients, AGA looks forward to supporting Dr. Marshall’s Senate candidacy and continuing to work with him and his office on issues and initiatives to advance the science and practice of gastroenterology.

[email protected]

Patients with COVID-19 and progressing cancer had a fivefold increase in the risk of 30-day mortality, compared with COVID-19–positive cancer patients who were in remission or had no evidence of cancer, according to data from the COVID-19 and Cancer Consortium (CCC19) registry.

Mongkolchon Akesin/Shutterstock

Other independent risk factors for death in patients with COVID-19 and cancer were older age, male sex, former smoking, number of comorbidities, Eastern Cooperative Oncology Group (ECOG) performance status of 2 or greater, and treatment with hydroxychloroquine plus azithromycin.

In fact, patients who received hydroxychloroquine and azithromycin had a nearly threefold higher risk of death than did patients who had not received the combination. However, this finding was of “uncertain validity due to a high risk of residual confounding; for example, patients receiving this combination were more likely to have severe disease or more likely to be hospitalized,” said Jeremy L. Warner, MD, of Vanderbilt University Medical Center in Nashville, Tennessee.

Dr. Warner presented these findings in an online press briefing. Additional findings from the CCC19 registry are set to be presented as part of the American Society of Clinical Oncology (ASCO) virtual scientific program. The findings were also published in The Lancet.

‘Severe impact’ in cancer patients

“For people with cancer, the impact of COVID-19 is especially severe, whether they have been exposed to the virus or not. Patients with cancer are typically older adults, often with other underlying conditions, and their immune systems may be suppressed by the cancer, or due to chemotherapy, radiation, or other treatment,” commented ASCO President Howard A. Burris III, MD, who moderated the press briefing but was not involved in the study of CCC19 registry data.

“ASCO members tell us that they have had to delay or modify treatment plans to reduce patients’ risk of infection, and we’re unclear what the impact of these changes will be. Delays in cancer screening and diagnosis are also a major concern,” Dr. Burris continued.

“This does confirm reports that have come out from other centers, including other parts of the world, where they have found that people who have cancer and COVID-19 have a worse outcome,” said Andrew T. Chan, MD, MPH, of Massachusetts General Hospital in Boston, who was not involved in the research.

Dr. Chan’s group has developed a COVID-19 symptom study app with the aim of defining whether people living with cancer are at increased risk for infections, in addition to whether cancer is an independent risk factor for COVID-19 severity or mortality.

“Using data from our app, we were able to show that people who reported living with cancer did have a higher risk of developing COVID and were more likely to be hospitalized related to COVID,” Dr. Chan said in an interview.
 

Study details

The CCC19 registry collects information from 104 participating institutions in the United States and Canada, as well as anonymous data from individuals in the United States, Argentina, Canada, the European Union, and the United Kingdom.

The sample of 928 patients Dr. Warner presented was evenly balanced by sex. The median age was 66 years, and 30% of patients were aged 75 years or older.

In all, 39% of patients were on active anticancer therapy, and 43% had measurable disease. Breast cancer was the most common diagnosis, followed by prostate cancer, gastrointestinal cancers, lymphomas, and thoracic cancers.

Two-thirds of the patients (68%) had an ECOG performance status of 0 or 1, 8% had a performance status of 2, and 5% a status of 3 or 4. The remaining patients had unknown performance status.

Slightly more than half of patients (52%) were never smokers, 37% were former smokers, and 5% were current smokers. The remaining 6% of patients had unknown smoking status.

At a median follow-up of 21 days, 121 patients (13%) had died. All deaths occurred within 30 days of COVID-19 diagnosis. Among patients who died, 78 were male, 64 were former smokers, 70 were aged 75 years or older, 41 had active stable or responding cancer, 25 had progressing cancer, and 42 had an ECOG performance status of 2 or higher.

In all, 466 patients were hospitalized, and 106 in this group (23%) died. Among the 132 patients admitted to an ICU, 50 (38%) died, including 27 patients aged 75 years or older, and 15 with an ECOG performance status of 2 or greater. Of the 116 patients who required intubation, 50 (43%) died, including 26 who were 75 years or older, and 11 who had a performance status of 2 or greater.

It’s early days yet, and a larger sample size with longer follow-up will be needed to get a more complete picture of how COVID-19 affects specific patient subsets over time, Dr. Warner said.

ASCO has established its own COVID-19 registry to collect both near-term and longitudinal data during the pandemic.

“We’ll be able to learn about both how the pandemic has impacted delivery of cancer care, as well as the longer-term effects of COVID-19 on cancer patients and understand what care approaches are working best,” said Richard L. Schilsky, MD, chief medical officer and executive vice president of ASCO, during the briefing.

The study of CCC19 registry data was supported in part by the National Institutes of Health and the American Cancer Society. Dr. Warner disclosed stock/ownership in HemOnc.org, consulting for IBM and Westat, and travel expenses from IBM. Dr. Burris, Dr. Schilsky, and Dr. Chan reported no disclosures relevant to the study.
 

SOURCE: Warner J L et al. ASCO 2020, Abstract LBA110.

Patients with COVID-19 and progressing cancer had a fivefold increase in the risk of 30-day mortality, compared with COVID-19–positive cancer patients who were in remission or had no evidence of cancer, according to data from the COVID-19 and Cancer Consortium (CCC19) registry.

Mongkolchon Akesin/Shutterstock

Other independent risk factors for death in patients with COVID-19 and cancer were older age, male sex, former smoking, number of comorbidities, Eastern Cooperative Oncology Group (ECOG) performance status of 2 or greater, and treatment with hydroxychloroquine plus azithromycin.

In fact, patients who received hydroxychloroquine and azithromycin had a nearly threefold higher risk of death than did patients who had not received the combination. However, this finding was of “uncertain validity due to a high risk of residual confounding; for example, patients receiving this combination were more likely to have severe disease or more likely to be hospitalized,” said Jeremy L. Warner, MD, of Vanderbilt University Medical Center in Nashville, Tennessee.

Dr. Warner presented these findings in an online press briefing. Additional findings from the CCC19 registry are set to be presented as part of the American Society of Clinical Oncology (ASCO) virtual scientific program. The findings were also published in The Lancet.

‘Severe impact’ in cancer patients

“For people with cancer, the impact of COVID-19 is especially severe, whether they have been exposed to the virus or not. Patients with cancer are typically older adults, often with other underlying conditions, and their immune systems may be suppressed by the cancer, or due to chemotherapy, radiation, or other treatment,” commented ASCO President Howard A. Burris III, MD, who moderated the press briefing but was not involved in the study of CCC19 registry data.

“ASCO members tell us that they have had to delay or modify treatment plans to reduce patients’ risk of infection, and we’re unclear what the impact of these changes will be. Delays in cancer screening and diagnosis are also a major concern,” Dr. Burris continued.

“This does confirm reports that have come out from other centers, including other parts of the world, where they have found that people who have cancer and COVID-19 have a worse outcome,” said Andrew T. Chan, MD, MPH, of Massachusetts General Hospital in Boston, who was not involved in the research.

Dr. Chan’s group has developed a COVID-19 symptom study app with the aim of defining whether people living with cancer are at increased risk for infections, in addition to whether cancer is an independent risk factor for COVID-19 severity or mortality.

“Using data from our app, we were able to show that people who reported living with cancer did have a higher risk of developing COVID and were more likely to be hospitalized related to COVID,” Dr. Chan said in an interview.
 

Study details

The CCC19 registry collects information from 104 participating institutions in the United States and Canada, as well as anonymous data from individuals in the United States, Argentina, Canada, the European Union, and the United Kingdom.

The sample of 928 patients Dr. Warner presented was evenly balanced by sex. The median age was 66 years, and 30% of patients were aged 75 years or older.

In all, 39% of patients were on active anticancer therapy, and 43% had measurable disease. Breast cancer was the most common diagnosis, followed by prostate cancer, gastrointestinal cancers, lymphomas, and thoracic cancers.

Two-thirds of the patients (68%) had an ECOG performance status of 0 or 1, 8% had a performance status of 2, and 5% a status of 3 or 4. The remaining patients had unknown performance status.

Slightly more than half of patients (52%) were never smokers, 37% were former smokers, and 5% were current smokers. The remaining 6% of patients had unknown smoking status.

At a median follow-up of 21 days, 121 patients (13%) had died. All deaths occurred within 30 days of COVID-19 diagnosis. Among patients who died, 78 were male, 64 were former smokers, 70 were aged 75 years or older, 41 had active stable or responding cancer, 25 had progressing cancer, and 42 had an ECOG performance status of 2 or higher.

In all, 466 patients were hospitalized, and 106 in this group (23%) died. Among the 132 patients admitted to an ICU, 50 (38%) died, including 27 patients aged 75 years or older, and 15 with an ECOG performance status of 2 or greater. Of the 116 patients who required intubation, 50 (43%) died, including 26 who were 75 years or older, and 11 who had a performance status of 2 or greater.

It’s early days yet, and a larger sample size with longer follow-up will be needed to get a more complete picture of how COVID-19 affects specific patient subsets over time, Dr. Warner said.

ASCO has established its own COVID-19 registry to collect both near-term and longitudinal data during the pandemic.

“We’ll be able to learn about both how the pandemic has impacted delivery of cancer care, as well as the longer-term effects of COVID-19 on cancer patients and understand what care approaches are working best,” said Richard L. Schilsky, MD, chief medical officer and executive vice president of ASCO, during the briefing.

The study of CCC19 registry data was supported in part by the National Institutes of Health and the American Cancer Society. Dr. Warner disclosed stock/ownership in HemOnc.org, consulting for IBM and Westat, and travel expenses from IBM. Dr. Burris, Dr. Schilsky, and Dr. Chan reported no disclosures relevant to the study.
 

SOURCE: Warner J L et al. ASCO 2020, Abstract LBA110.

Patients with COVID-19 and progressing cancer had a fivefold increase in the risk of 30-day mortality, compared with COVID-19–positive cancer patients who were in remission or had no evidence of cancer, according to data from the COVID-19 and Cancer Consortium (CCC19) registry.

Mongkolchon Akesin/Shutterstock

Other independent risk factors for death in patients with COVID-19 and cancer were older age, male sex, former smoking, number of comorbidities, Eastern Cooperative Oncology Group (ECOG) performance status of 2 or greater, and treatment with hydroxychloroquine plus azithromycin.

In fact, patients who received hydroxychloroquine and azithromycin had a nearly threefold higher risk of death than did patients who had not received the combination. However, this finding was of “uncertain validity due to a high risk of residual confounding; for example, patients receiving this combination were more likely to have severe disease or more likely to be hospitalized,” said Jeremy L. Warner, MD, of Vanderbilt University Medical Center in Nashville, Tennessee.

Dr. Warner presented these findings in an online press briefing. Additional findings from the CCC19 registry are set to be presented as part of the American Society of Clinical Oncology (ASCO) virtual scientific program. The findings were also published in The Lancet.

‘Severe impact’ in cancer patients

“For people with cancer, the impact of COVID-19 is especially severe, whether they have been exposed to the virus or not. Patients with cancer are typically older adults, often with other underlying conditions, and their immune systems may be suppressed by the cancer, or due to chemotherapy, radiation, or other treatment,” commented ASCO President Howard A. Burris III, MD, who moderated the press briefing but was not involved in the study of CCC19 registry data.

“ASCO members tell us that they have had to delay or modify treatment plans to reduce patients’ risk of infection, and we’re unclear what the impact of these changes will be. Delays in cancer screening and diagnosis are also a major concern,” Dr. Burris continued.

“This does confirm reports that have come out from other centers, including other parts of the world, where they have found that people who have cancer and COVID-19 have a worse outcome,” said Andrew T. Chan, MD, MPH, of Massachusetts General Hospital in Boston, who was not involved in the research.

Dr. Chan’s group has developed a COVID-19 symptom study app with the aim of defining whether people living with cancer are at increased risk for infections, in addition to whether cancer is an independent risk factor for COVID-19 severity or mortality.

“Using data from our app, we were able to show that people who reported living with cancer did have a higher risk of developing COVID and were more likely to be hospitalized related to COVID,” Dr. Chan said in an interview.
 

Study details

The CCC19 registry collects information from 104 participating institutions in the United States and Canada, as well as anonymous data from individuals in the United States, Argentina, Canada, the European Union, and the United Kingdom.

The sample of 928 patients Dr. Warner presented was evenly balanced by sex. The median age was 66 years, and 30% of patients were aged 75 years or older.

In all, 39% of patients were on active anticancer therapy, and 43% had measurable disease. Breast cancer was the most common diagnosis, followed by prostate cancer, gastrointestinal cancers, lymphomas, and thoracic cancers.

Two-thirds of the patients (68%) had an ECOG performance status of 0 or 1, 8% had a performance status of 2, and 5% a status of 3 or 4. The remaining patients had unknown performance status.

Slightly more than half of patients (52%) were never smokers, 37% were former smokers, and 5% were current smokers. The remaining 6% of patients had unknown smoking status.

At a median follow-up of 21 days, 121 patients (13%) had died. All deaths occurred within 30 days of COVID-19 diagnosis. Among patients who died, 78 were male, 64 were former smokers, 70 were aged 75 years or older, 41 had active stable or responding cancer, 25 had progressing cancer, and 42 had an ECOG performance status of 2 or higher.

In all, 466 patients were hospitalized, and 106 in this group (23%) died. Among the 132 patients admitted to an ICU, 50 (38%) died, including 27 patients aged 75 years or older, and 15 with an ECOG performance status of 2 or greater. Of the 116 patients who required intubation, 50 (43%) died, including 26 who were 75 years or older, and 11 who had a performance status of 2 or greater.

It’s early days yet, and a larger sample size with longer follow-up will be needed to get a more complete picture of how COVID-19 affects specific patient subsets over time, Dr. Warner said.

ASCO has established its own COVID-19 registry to collect both near-term and longitudinal data during the pandemic.

“We’ll be able to learn about both how the pandemic has impacted delivery of cancer care, as well as the longer-term effects of COVID-19 on cancer patients and understand what care approaches are working best,” said Richard L. Schilsky, MD, chief medical officer and executive vice president of ASCO, during the briefing.

The study of CCC19 registry data was supported in part by the National Institutes of Health and the American Cancer Society. Dr. Warner disclosed stock/ownership in HemOnc.org, consulting for IBM and Westat, and travel expenses from IBM. Dr. Burris, Dr. Schilsky, and Dr. Chan reported no disclosures relevant to the study.
 

SOURCE: Warner J L et al. ASCO 2020, Abstract LBA110.

Adjuvant therapy with osimertinib was associated with a nearly 80% reduction in the risk of disease recurrence or death in patients with stage IB-IIIA non–small cell lung cancer (NSCLC) bearing EGFR mutations, results of the ADAURA trial showed.

The randomized, phase 3 trial was a comparison of osimertinib treatment with placebo following complete resection of localized or locally advanced NSCLC with negative margins. The trial was unblinded early and halted on the recommendation of the independent data-monitoring committee, due to the efficacy of osimertinib.

“If I were on the committee, I would have done the same thing. These are extraordinary results,” said study investigator Roy S. Herbst, MD, PhD, chief of medical oncology at the Yale Cancer Center and Smilow Cancer Center at Yale University in New Haven, Conn.

Dr. Herbst is scheduled to present results from ADAURA as part of the American Society of Clinical Oncology virtual scientific program.

In an online briefing prior to the meeting, Dr. Herbst said the impressive results reminded him of a lesson imparted by his mentor, the late Isaiah Fidler, DVM, PhD.

“He taught me, he taught all of us, that metastasis is a spread of tumor that kills patients,” Dr. Herbst said. “Drugs such as this, based on biology, given to patients at the earliest possible time, prevent those metastases and allow patients to live longer and with a better quality of life.”

Results from the ADAURA trial provide compelling evidence of the benefit of adjuvant osimertinib for a select group of patients, according to Tina Cascone, MD, PhD, assistant professor in the department of thoracic head and neck medical oncology at The University of Texas MD Anderson Cancer Center in Houston. She was not involved in the study.

“These are unprecedented results for a potentially curable, resected population of patients,” Dr. Cascone said in an interview. “This definitely has the potential to shift the paradigm in the treatments that we have available for patients with resected disease. It’s very important to emphasize how much we’ve learned from the metastatic setting and how we’re bringing what we’ve learned into early stage disease.”

 

High recurrence rates

An estimated 30% of patients with NSCLC present with resectable disease at diagnosis, but 5-year recurrence rates following surgery and cisplatin-based adjuvant chemotherapy remain high, ranging from 45% among patients with stage IB disease to 62% for patients with stage II NSCLC and 76% for patients with stage III disease, Dr. Herbst noted.

Osimertinib is a third-generation tyrosine kinase inhibitor (TKI) targeted to EGFR. It has been shown to offer improvements in both progression-free survival and overall survival compared with the EGFR-TKIs erlotinib and gefitinib for patients with advanced EGFR-mutated NSCLC, as well as in patients with central nervous system metastases.

Osimertinib’s efficacy and safety profile against advanced disease suggests it may also be effective against early stage disease, a hypothesis the ADAURA trial was designed to test.
 

Study details

The phase 3, randomized, double-blind trial was conducted at centers in the United States, Europe, Asia, and Australia. A total of 682 patients with completely resected stage IB, II, or IIIA NSCLC, with or without planned adjuvant chemotherapy, were enrolled.

After stratification by stage, EGFR mutation, and race (Asian vs. non-Asian), patients were randomized on a 1:1 basis to receive either osimertinib at 80 mg once daily or placebo. The planned treatment duration was a maximum of 3 years.

Members of the independent data-monitoring committee held a meeting in April 2020. Although they had not planned an efficacy analysis at that time, they decided the results were clearly in favor of osimertinib. So they recommended unblinding and halting of the trial.

At the time of unblinding, the study had completed enrollment, and all patients had been followed for at least 1 year.
 

Efficacy and safety

For the primary endpoint of disease-free survival (DFS) in patients with stage II to IIIA disease, the median DFS was not reached for patients assigned to osimertinib, but it was 20.4 months for patients assigned to placebo (hazard ratio, 0.17; P < .0001).

The numbers were similar for the secondary endpoint of DFS in the overall population, including patients with stage IB disease. The median DFS was not reached for patients on osimertinib but was 28.1 months for patients on placebo (HR, 0.21; P < .0001).

DFS was significantly superior with osimertinib across all subgroups in the overall population, including sex, age, smoking status, race, stage, EGFR mutation, and adjuvant chemotherapy (yes or no).

Dr. Herbst said patients tolerated osimertinib well, and the drug’s safety profile was consistent with that already known. There were no adverse events leading to death in the osimertinib arm, and the incidence of grade 3 or 4 adverse events of any kind was low.

In all, 10 patients (3%) in the osimertinib arm were reported to have interstitial lung disease. Prolongation of the QT interval was reported in 22 patients (7%) on osimertinib and 4 patients (1%) in the placebo arm.

The results show that “adjuvant osimertinib provides a highly effective, practice-changing treatment for patients with stage IB, II, IIIA, EGFR mutation-positive non–small cell lung cancer after complete tumor resection,” Dr. Herbst said.

Dr. Herbst disclosed relationships with AstraZeneca, which funded the study, as well as Jun Shi Pharmaceuticals and other companies. Dr. Cascone is the international principal investigator of the NeoCOAST trial evaluating durvalumab, an AstraZeneca product.

SOURCE: Herbst RS et al. ASCO 2020, Abstract LBA5.

Adjuvant therapy with osimertinib was associated with a nearly 80% reduction in the risk of disease recurrence or death in patients with stage IB-IIIA non–small cell lung cancer (NSCLC) bearing EGFR mutations, results of the ADAURA trial showed.

The randomized, phase 3 trial was a comparison of osimertinib treatment with placebo following complete resection of localized or locally advanced NSCLC with negative margins. The trial was unblinded early and halted on the recommendation of the independent data-monitoring committee, due to the efficacy of osimertinib.

“If I were on the committee, I would have done the same thing. These are extraordinary results,” said study investigator Roy S. Herbst, MD, PhD, chief of medical oncology at the Yale Cancer Center and Smilow Cancer Center at Yale University in New Haven, Conn.

Dr. Herbst is scheduled to present results from ADAURA as part of the American Society of Clinical Oncology virtual scientific program.

In an online briefing prior to the meeting, Dr. Herbst said the impressive results reminded him of a lesson imparted by his mentor, the late Isaiah Fidler, DVM, PhD.

“He taught me, he taught all of us, that metastasis is a spread of tumor that kills patients,” Dr. Herbst said. “Drugs such as this, based on biology, given to patients at the earliest possible time, prevent those metastases and allow patients to live longer and with a better quality of life.”

Results from the ADAURA trial provide compelling evidence of the benefit of adjuvant osimertinib for a select group of patients, according to Tina Cascone, MD, PhD, assistant professor in the department of thoracic head and neck medical oncology at The University of Texas MD Anderson Cancer Center in Houston. She was not involved in the study.

“These are unprecedented results for a potentially curable, resected population of patients,” Dr. Cascone said in an interview. “This definitely has the potential to shift the paradigm in the treatments that we have available for patients with resected disease. It’s very important to emphasize how much we’ve learned from the metastatic setting and how we’re bringing what we’ve learned into early stage disease.”

 

High recurrence rates

An estimated 30% of patients with NSCLC present with resectable disease at diagnosis, but 5-year recurrence rates following surgery and cisplatin-based adjuvant chemotherapy remain high, ranging from 45% among patients with stage IB disease to 62% for patients with stage II NSCLC and 76% for patients with stage III disease, Dr. Herbst noted.

Osimertinib is a third-generation tyrosine kinase inhibitor (TKI) targeted to EGFR. It has been shown to offer improvements in both progression-free survival and overall survival compared with the EGFR-TKIs erlotinib and gefitinib for patients with advanced EGFR-mutated NSCLC, as well as in patients with central nervous system metastases.

Osimertinib’s efficacy and safety profile against advanced disease suggests it may also be effective against early stage disease, a hypothesis the ADAURA trial was designed to test.
 

Study details

The phase 3, randomized, double-blind trial was conducted at centers in the United States, Europe, Asia, and Australia. A total of 682 patients with completely resected stage IB, II, or IIIA NSCLC, with or without planned adjuvant chemotherapy, were enrolled.

After stratification by stage, EGFR mutation, and race (Asian vs. non-Asian), patients were randomized on a 1:1 basis to receive either osimertinib at 80 mg once daily or placebo. The planned treatment duration was a maximum of 3 years.

Members of the independent data-monitoring committee held a meeting in April 2020. Although they had not planned an efficacy analysis at that time, they decided the results were clearly in favor of osimertinib. So they recommended unblinding and halting of the trial.

At the time of unblinding, the study had completed enrollment, and all patients had been followed for at least 1 year.
 

Efficacy and safety

For the primary endpoint of disease-free survival (DFS) in patients with stage II to IIIA disease, the median DFS was not reached for patients assigned to osimertinib, but it was 20.4 months for patients assigned to placebo (hazard ratio, 0.17; P < .0001).

The numbers were similar for the secondary endpoint of DFS in the overall population, including patients with stage IB disease. The median DFS was not reached for patients on osimertinib but was 28.1 months for patients on placebo (HR, 0.21; P < .0001).

DFS was significantly superior with osimertinib across all subgroups in the overall population, including sex, age, smoking status, race, stage, EGFR mutation, and adjuvant chemotherapy (yes or no).

Dr. Herbst said patients tolerated osimertinib well, and the drug’s safety profile was consistent with that already known. There were no adverse events leading to death in the osimertinib arm, and the incidence of grade 3 or 4 adverse events of any kind was low.

In all, 10 patients (3%) in the osimertinib arm were reported to have interstitial lung disease. Prolongation of the QT interval was reported in 22 patients (7%) on osimertinib and 4 patients (1%) in the placebo arm.

The results show that “adjuvant osimertinib provides a highly effective, practice-changing treatment for patients with stage IB, II, IIIA, EGFR mutation-positive non–small cell lung cancer after complete tumor resection,” Dr. Herbst said.

Dr. Herbst disclosed relationships with AstraZeneca, which funded the study, as well as Jun Shi Pharmaceuticals and other companies. Dr. Cascone is the international principal investigator of the NeoCOAST trial evaluating durvalumab, an AstraZeneca product.

SOURCE: Herbst RS et al. ASCO 2020, Abstract LBA5.

Adjuvant therapy with osimertinib was associated with a nearly 80% reduction in the risk of disease recurrence or death in patients with stage IB-IIIA non–small cell lung cancer (NSCLC) bearing EGFR mutations, results of the ADAURA trial showed.

The randomized, phase 3 trial was a comparison of osimertinib treatment with placebo following complete resection of localized or locally advanced NSCLC with negative margins. The trial was unblinded early and halted on the recommendation of the independent data-monitoring committee, due to the efficacy of osimertinib.

“If I were on the committee, I would have done the same thing. These are extraordinary results,” said study investigator Roy S. Herbst, MD, PhD, chief of medical oncology at the Yale Cancer Center and Smilow Cancer Center at Yale University in New Haven, Conn.

Dr. Herbst is scheduled to present results from ADAURA as part of the American Society of Clinical Oncology virtual scientific program.

In an online briefing prior to the meeting, Dr. Herbst said the impressive results reminded him of a lesson imparted by his mentor, the late Isaiah Fidler, DVM, PhD.

“He taught me, he taught all of us, that metastasis is a spread of tumor that kills patients,” Dr. Herbst said. “Drugs such as this, based on biology, given to patients at the earliest possible time, prevent those metastases and allow patients to live longer and with a better quality of life.”

Results from the ADAURA trial provide compelling evidence of the benefit of adjuvant osimertinib for a select group of patients, according to Tina Cascone, MD, PhD, assistant professor in the department of thoracic head and neck medical oncology at The University of Texas MD Anderson Cancer Center in Houston. She was not involved in the study.

“These are unprecedented results for a potentially curable, resected population of patients,” Dr. Cascone said in an interview. “This definitely has the potential to shift the paradigm in the treatments that we have available for patients with resected disease. It’s very important to emphasize how much we’ve learned from the metastatic setting and how we’re bringing what we’ve learned into early stage disease.”

 

High recurrence rates

An estimated 30% of patients with NSCLC present with resectable disease at diagnosis, but 5-year recurrence rates following surgery and cisplatin-based adjuvant chemotherapy remain high, ranging from 45% among patients with stage IB disease to 62% for patients with stage II NSCLC and 76% for patients with stage III disease, Dr. Herbst noted.

Osimertinib is a third-generation tyrosine kinase inhibitor (TKI) targeted to EGFR. It has been shown to offer improvements in both progression-free survival and overall survival compared with the EGFR-TKIs erlotinib and gefitinib for patients with advanced EGFR-mutated NSCLC, as well as in patients with central nervous system metastases.

Osimertinib’s efficacy and safety profile against advanced disease suggests it may also be effective against early stage disease, a hypothesis the ADAURA trial was designed to test.
 

Study details

The phase 3, randomized, double-blind trial was conducted at centers in the United States, Europe, Asia, and Australia. A total of 682 patients with completely resected stage IB, II, or IIIA NSCLC, with or without planned adjuvant chemotherapy, were enrolled.

After stratification by stage, EGFR mutation, and race (Asian vs. non-Asian), patients were randomized on a 1:1 basis to receive either osimertinib at 80 mg once daily or placebo. The planned treatment duration was a maximum of 3 years.

Members of the independent data-monitoring committee held a meeting in April 2020. Although they had not planned an efficacy analysis at that time, they decided the results were clearly in favor of osimertinib. So they recommended unblinding and halting of the trial.

At the time of unblinding, the study had completed enrollment, and all patients had been followed for at least 1 year.
 

Efficacy and safety

For the primary endpoint of disease-free survival (DFS) in patients with stage II to IIIA disease, the median DFS was not reached for patients assigned to osimertinib, but it was 20.4 months for patients assigned to placebo (hazard ratio, 0.17; P < .0001).

The numbers were similar for the secondary endpoint of DFS in the overall population, including patients with stage IB disease. The median DFS was not reached for patients on osimertinib but was 28.1 months for patients on placebo (HR, 0.21; P < .0001).

DFS was significantly superior with osimertinib across all subgroups in the overall population, including sex, age, smoking status, race, stage, EGFR mutation, and adjuvant chemotherapy (yes or no).

Dr. Herbst said patients tolerated osimertinib well, and the drug’s safety profile was consistent with that already known. There were no adverse events leading to death in the osimertinib arm, and the incidence of grade 3 or 4 adverse events of any kind was low.

In all, 10 patients (3%) in the osimertinib arm were reported to have interstitial lung disease. Prolongation of the QT interval was reported in 22 patients (7%) on osimertinib and 4 patients (1%) in the placebo arm.

The results show that “adjuvant osimertinib provides a highly effective, practice-changing treatment for patients with stage IB, II, IIIA, EGFR mutation-positive non–small cell lung cancer after complete tumor resection,” Dr. Herbst said.

Dr. Herbst disclosed relationships with AstraZeneca, which funded the study, as well as Jun Shi Pharmaceuticals and other companies. Dr. Cascone is the international principal investigator of the NeoCOAST trial evaluating durvalumab, an AstraZeneca product.

SOURCE: Herbst RS et al. ASCO 2020, Abstract LBA5.

Here are the stories our MDedge editors across specialties think you need to know about today:

Long road to recovery includes lung rehab

For seriously ill COVID-19 patients, there may a long recovery period even after leaving the intensive care unit. Eladio (“Lad”) Braganza, age 77, is one of those patients. For 28 days, he was on a ventilator in a Seattle ICU. Now – after a 46-day hospitalization for SARS-CoV-2 infection – he’s making progress in inpatient rehab. “The vast majority of COVID patients in the ICU have lung disease that is quite severe, much more severe than I have seen in my 20 years of doing this,” said critical care specialist Anna Nolan, MD, of the department of medicine at New York University. READ MORE.

Detox unit keeps running during COVID-19

Substance use disorder doesn’t take a break for a pandemic. In fact, the stressors from the current COVID-19 situation have increased substance use. In a commentary published on MDedge, Keji Fagbemi, MD, a hospitalist at the BronxCare Health System, shared how his hospital kept its inpatient detoxification unit running, despite the challenges presented by COVID-19. “At a time when many inpatient detoxification units within the city were temporarily closed due to fear of inpatient spread of the virus or to provide extra COVID beds in anticipation for the peak surge, we have been able to provide a needed service,” he wrote. “In fact, several other inpatient detoxification programs within the city have been able to refer their patients to our facility.” READ MORE.

Air pollution linked to MS risk

Air pollution may be another environmental risk factor for developing multiple sclerosis, suggests new research released as part of the Congress of the European Academy of Neurology (EAN) 2020. The findings, which are based on a large cohort study of nearly 550,000 individuals in Italy, appear to confirm the relationship between exposure to air pollutants and risk for MS that has been shown in prior studies. “Countermeasures that cut air pollution can be important for public health, not only to reduce deaths related to cardiac and pulmonary diseases but also the risk of chronic autoimmune diseases such as MS,” said Roberto Bergamaschi, MD, PhD, director of the Multiple Sclerosis Center, IRCCS Mondino Foundation, Pavia, Italy. READ MORE.
 

Trials produce conflicting results in Alzheimer’s disease

High-dose aducanumab, a human monoclonal antibody in development for the treatment of Alzheimer’s disease, significantly reduced clinical decline in people with early disease in one randomized, placebo-controlled phase 3 study. But there was no statistically significant change in outcomes in an identical study. “We believe that the difference between the results was largely due to patients’ greater exposure to the high dose of aducanumab,” said Samantha Budd Haeberlein, PhD, one of the study investigators and senior vice president and head of the neurodegeneration development unit at Biogen, which is developing the drug. READ MORE.

Pregnant patients have asymptomatic SARS-CoV-2 infection

The rate of asymptomatic SARS-CoV-2 infection was 16% among women with a planned delivery in a New York City health system during the first half of April, according to recent study results. “If universal testing of pregnant patients in a high prevalence area is not performed, health care workers will be inadvertently exposed to COVID-19, unless universal precautions with personal protective equipment are taken,” researchers wrote in Obstetrics & Gynecology. READ MORE.

For more on COVID-19, visit our Resource Center. All of our latest news is available on MDedge.com.

Here are the stories our MDedge editors across specialties think you need to know about today:

Long road to recovery includes lung rehab

For seriously ill COVID-19 patients, there may a long recovery period even after leaving the intensive care unit. Eladio (“Lad”) Braganza, age 77, is one of those patients. For 28 days, he was on a ventilator in a Seattle ICU. Now – after a 46-day hospitalization for SARS-CoV-2 infection – he’s making progress in inpatient rehab. “The vast majority of COVID patients in the ICU have lung disease that is quite severe, much more severe than I have seen in my 20 years of doing this,” said critical care specialist Anna Nolan, MD, of the department of medicine at New York University. READ MORE.

Detox unit keeps running during COVID-19

Substance use disorder doesn’t take a break for a pandemic. In fact, the stressors from the current COVID-19 situation have increased substance use. In a commentary published on MDedge, Keji Fagbemi, MD, a hospitalist at the BronxCare Health System, shared how his hospital kept its inpatient detoxification unit running, despite the challenges presented by COVID-19. “At a time when many inpatient detoxification units within the city were temporarily closed due to fear of inpatient spread of the virus or to provide extra COVID beds in anticipation for the peak surge, we have been able to provide a needed service,” he wrote. “In fact, several other inpatient detoxification programs within the city have been able to refer their patients to our facility.” READ MORE.

Air pollution linked to MS risk

Air pollution may be another environmental risk factor for developing multiple sclerosis, suggests new research released as part of the Congress of the European Academy of Neurology (EAN) 2020. The findings, which are based on a large cohort study of nearly 550,000 individuals in Italy, appear to confirm the relationship between exposure to air pollutants and risk for MS that has been shown in prior studies. “Countermeasures that cut air pollution can be important for public health, not only to reduce deaths related to cardiac and pulmonary diseases but also the risk of chronic autoimmune diseases such as MS,” said Roberto Bergamaschi, MD, PhD, director of the Multiple Sclerosis Center, IRCCS Mondino Foundation, Pavia, Italy. READ MORE.
 

Trials produce conflicting results in Alzheimer’s disease

High-dose aducanumab, a human monoclonal antibody in development for the treatment of Alzheimer’s disease, significantly reduced clinical decline in people with early disease in one randomized, placebo-controlled phase 3 study. But there was no statistically significant change in outcomes in an identical study. “We believe that the difference between the results was largely due to patients’ greater exposure to the high dose of aducanumab,” said Samantha Budd Haeberlein, PhD, one of the study investigators and senior vice president and head of the neurodegeneration development unit at Biogen, which is developing the drug. READ MORE.

Pregnant patients have asymptomatic SARS-CoV-2 infection

The rate of asymptomatic SARS-CoV-2 infection was 16% among women with a planned delivery in a New York City health system during the first half of April, according to recent study results. “If universal testing of pregnant patients in a high prevalence area is not performed, health care workers will be inadvertently exposed to COVID-19, unless universal precautions with personal protective equipment are taken,” researchers wrote in Obstetrics & Gynecology. READ MORE.

For more on COVID-19, visit our Resource Center. All of our latest news is available on MDedge.com.

Here are the stories our MDedge editors across specialties think you need to know about today:

Long road to recovery includes lung rehab

For seriously ill COVID-19 patients, there may a long recovery period even after leaving the intensive care unit. Eladio (“Lad”) Braganza, age 77, is one of those patients. For 28 days, he was on a ventilator in a Seattle ICU. Now – after a 46-day hospitalization for SARS-CoV-2 infection – he’s making progress in inpatient rehab. “The vast majority of COVID patients in the ICU have lung disease that is quite severe, much more severe than I have seen in my 20 years of doing this,” said critical care specialist Anna Nolan, MD, of the department of medicine at New York University. READ MORE.

Detox unit keeps running during COVID-19

Substance use disorder doesn’t take a break for a pandemic. In fact, the stressors from the current COVID-19 situation have increased substance use. In a commentary published on MDedge, Keji Fagbemi, MD, a hospitalist at the BronxCare Health System, shared how his hospital kept its inpatient detoxification unit running, despite the challenges presented by COVID-19. “At a time when many inpatient detoxification units within the city were temporarily closed due to fear of inpatient spread of the virus or to provide extra COVID beds in anticipation for the peak surge, we have been able to provide a needed service,” he wrote. “In fact, several other inpatient detoxification programs within the city have been able to refer their patients to our facility.” READ MORE.

Air pollution linked to MS risk

Air pollution may be another environmental risk factor for developing multiple sclerosis, suggests new research released as part of the Congress of the European Academy of Neurology (EAN) 2020. The findings, which are based on a large cohort study of nearly 550,000 individuals in Italy, appear to confirm the relationship between exposure to air pollutants and risk for MS that has been shown in prior studies. “Countermeasures that cut air pollution can be important for public health, not only to reduce deaths related to cardiac and pulmonary diseases but also the risk of chronic autoimmune diseases such as MS,” said Roberto Bergamaschi, MD, PhD, director of the Multiple Sclerosis Center, IRCCS Mondino Foundation, Pavia, Italy. READ MORE.
 

Trials produce conflicting results in Alzheimer’s disease

High-dose aducanumab, a human monoclonal antibody in development for the treatment of Alzheimer’s disease, significantly reduced clinical decline in people with early disease in one randomized, placebo-controlled phase 3 study. But there was no statistically significant change in outcomes in an identical study. “We believe that the difference between the results was largely due to patients’ greater exposure to the high dose of aducanumab,” said Samantha Budd Haeberlein, PhD, one of the study investigators and senior vice president and head of the neurodegeneration development unit at Biogen, which is developing the drug. READ MORE.

Pregnant patients have asymptomatic SARS-CoV-2 infection

The rate of asymptomatic SARS-CoV-2 infection was 16% among women with a planned delivery in a New York City health system during the first half of April, according to recent study results. “If universal testing of pregnant patients in a high prevalence area is not performed, health care workers will be inadvertently exposed to COVID-19, unless universal precautions with personal protective equipment are taken,” researchers wrote in Obstetrics & Gynecology. READ MORE.

For more on COVID-19, visit our Resource Center. All of our latest news is available on MDedge.com.

AGA just released GI Distance Learning, agau.gastro.org/diweb/catalog/q/GI-Distance-Learning, a new initiative providing AGA trainee members and medical residents a complementary set of curated education and career development resources available online. A part of AGA University, GI Distance Learning enables you to enhance your knowledge in a number of GI-related topics at your own pace from the comfort of home.

Through GI Distance Learning, you will have free access until Aug. 1 to the 800+ questions and answers included in the DDSEP^® 9 Question Bank. Assess your knowledge, identify gaps in learning, and stay current on the latest advances in GI and liver disease.

To access the Question Bank free of charge:

• Visit AGA University and sign in to your AGA account.
• Go to the DDSEP 9 Question Bank.
• Add the Question Bank to your Cart and Checkout.
• Type DDSEP9Distance in the Discount Code box.
• Apply the discount and submit your order.
• Use the My Courses link to access the Question Bank.

During the COVID-19 pandemic, many of us are struggling with the new normal and changes in our daily routines. Resiliency, emotional intelligence, and strategies for combatting burnout become increasingly important. The following on-demand resources from GI Distance Learning can help.

• Resilient Leadership
• Emotional Intelligence
• Strategies to Combat Burnout in GI and Maintaining Work/Life Balance

Continue to check back regularly at AGA University as we will continue to add resources to GI Distance Learning in the coming weeks.

[email protected]

AGA just released GI Distance Learning, agau.gastro.org/diweb/catalog/q/GI-Distance-Learning, a new initiative providing AGA trainee members and medical residents a complementary set of curated education and career development resources available online. A part of AGA University, GI Distance Learning enables you to enhance your knowledge in a number of GI-related topics at your own pace from the comfort of home.

Through GI Distance Learning, you will have free access until Aug. 1 to the 800+ questions and answers included in the DDSEP^® 9 Question Bank. Assess your knowledge, identify gaps in learning, and stay current on the latest advances in GI and liver disease.

To access the Question Bank free of charge:

• Visit AGA University and sign in to your AGA account.
• Go to the DDSEP 9 Question Bank.
• Add the Question Bank to your Cart and Checkout.
• Type DDSEP9Distance in the Discount Code box.
• Apply the discount and submit your order.
• Use the My Courses link to access the Question Bank.

During the COVID-19 pandemic, many of us are struggling with the new normal and changes in our daily routines. Resiliency, emotional intelligence, and strategies for combatting burnout become increasingly important. The following on-demand resources from GI Distance Learning can help.

• Resilient Leadership
• Emotional Intelligence
• Strategies to Combat Burnout in GI and Maintaining Work/Life Balance

Continue to check back regularly at AGA University as we will continue to add resources to GI Distance Learning in the coming weeks.

[email protected]

AGA just released GI Distance Learning, agau.gastro.org/diweb/catalog/q/GI-Distance-Learning, a new initiative providing AGA trainee members and medical residents a complementary set of curated education and career development resources available online. A part of AGA University, GI Distance Learning enables you to enhance your knowledge in a number of GI-related topics at your own pace from the comfort of home.

Through GI Distance Learning, you will have free access until Aug. 1 to the 800+ questions and answers included in the DDSEP^® 9 Question Bank. Assess your knowledge, identify gaps in learning, and stay current on the latest advances in GI and liver disease.

To access the Question Bank free of charge:

• Visit AGA University and sign in to your AGA account.
• Go to the DDSEP 9 Question Bank.
• Add the Question Bank to your Cart and Checkout.
• Type DDSEP9Distance in the Discount Code box.
• Apply the discount and submit your order.
• Use the My Courses link to access the Question Bank.

During the COVID-19 pandemic, many of us are struggling with the new normal and changes in our daily routines. Resiliency, emotional intelligence, and strategies for combatting burnout become increasingly important. The following on-demand resources from GI Distance Learning can help.

• Resilient Leadership
• Emotional Intelligence
• Strategies to Combat Burnout in GI and Maintaining Work/Life Balance

Continue to check back regularly at AGA University as we will continue to add resources to GI Distance Learning in the coming weeks.

[email protected]

Patients with relapsing multiple sclerosis (MS) who switch from treatment with the highly effective disease-modifying therapy natalizumab to a moderate-efficacy DMT show an increased risk of disability accumulation and disease activity over 2 years compared with switching to another highly effective DMT, new research shows.

“Owing to the vast number of available DMTs, not only understanding DMT performance but answering the question of what can come next if a patient needs to discontinue treatment due to safety or breakthrough disease is important,” said lead author Carrie M. Hersh, DO, of the Lou Ruvo Center for Brain Health, Cleveland Clinic, Las Vegas.

The study shows that, “patients transitioning from natalizumab to another high-efficacy therapy have better inflammatory and disability outcomes compared with those who de-escalate their therapy to a moderate-efficacy DMT,” she said.

Natalizumab (Tysabri) offers significant benefits in the treatment of relapsing forms of MS, however, its long-term use is associated with safety concerns, notably an increased risk of progressive multifocal leukoencephalopathy (PML). Although the risk can be reduced with a switch to a different DMT, the transition can have risks of its own, including a rebound of disease activity that could prove to be worse than the pre-natalizumab treatment period, and there is a lack of consensus on the safest avenues for switching to another DMT following discontinuation of natalizumab.

In research presented at the virtual meeting of the Consortium of Multiple Sclerosis Centers, Dr. Hersh and colleagues explored the issue in a real-world population of 556 patients discontinuing natalizumab at two MS centers. Of these, 270 switched to a moderate DMT (dimethyl fumarate, n = 130; or fingolimod, n = 140) and 130 switched to a highly effective DMT (ocrelizumab, n = 106; rituximab, n = 17; or alemtuzumab, n = 7).

Reasons for switching included a PML risk for 54.9%, breakthrough disease for 15.3%, and adverse effects for 17.3%.

At 24-month follow-up after the switch and after adjustment for propensity score matching, no differences were seen between the moderate and highly effective DMT groups in terms of the annualized relapse rate (ARR; P = 0.33) or the time to first relapse (P = 0.09).

However, significantly higher proportions of patients switching to moderate DMTs showed new T2 lesions (odds ratio, 2.15; P = .01), as well as new gadolinium-enhancing lesions (OR, 1.99; P = .02), and a 20% worsening of the timed 25-foot walk test (T25FW; OR, 1.83; P = .04) and 9-hole peg test (9-HPT; OR, 1.81; P = .04)

Those switching to moderate DMTs also had significantly lower rates of absence of disease activity over the 24 months (OR, 0.41, P = .004), and they had a higher risk of earlier time-to-first gadolinium-enhancing lesion (hazard ratio, 6.67, P = .002), compared with those switching to a high-efficacy DMT.

Other factors that have previously been shown to be associated with rebounds that are worse than pre-natalizumab treatment include washout periods that are longer than 3 months.

The authors noted that there were no significant differences between the groups in terms of mean washout duration, which were relatively short (moderate DMT, 1.4 months; highly effective treatment, 1.8 months; P = .34), In addition, there were no significant differences between the groups in terms of the average duration of natalizumab treatment.

Dr. Hersh speculated that the lack of ARR differences may reflect that the measure is not as objective as the more specific determinants of performance. “One could consider the comparable ARR as a little surprising, but relapse evaluation in a retrospective manner is limited,” she explained.

“Historically, radiographic markers of new inflammation via brain magnetic resonance imaging (MRI) and neuroperformance measures (T25FW and 9-HPT) are more objective compared to assessing clinical relapses, especially in a retrospective cohort where relapses cannot be validated by a central agency or the principal investigator. Therefore, one can surmise that patients transitioning from natalizumab to another high-efficacy DMT fare better than de-escalating treatment to a moderate-efficacy DMT.”

Dr. Hersh and team plan a larger, multicenter study to investigate the short- and long-term effects of post-natalizumab DMT sequencing to help validate the current findings.

Commenting on the research, Stephen Kamin, MD, professor, vice chair and chief of service, department of neurology, New Jersey Medical School, Newark, said the results are consistent with natalizumab’s general profile.

“In general, natalizumab has been used in patients with highly active disease, so I would expect fewer patients with no evidence of disease activity when switched to a moderately active drug rather than a highly active one,” he said in an interview.

Caveats of the findings include the trial’s observational nature, meaning potential confounding factors of baseline characteristics among patients who switched regimens are not known, noted Dr. Kamin, who was not involved with the study.

“Also, the patients were switched to a variety of drugs and even within a class there may be differences in outcome,” he explained.

Dr. Hersh reported consulting or research relationships with Biogen, Genentech, EMD Serono, Genzyme, Novartis, and PCORI. Dr. Kamin has received research support from Biogen, Novartis, and the Consortium of Multiple Sclerosis Centers.

This article first appeared on Medscape.com.

Patients with relapsing multiple sclerosis (MS) who switch from treatment with the highly effective disease-modifying therapy natalizumab to a moderate-efficacy DMT show an increased risk of disability accumulation and disease activity over 2 years compared with switching to another highly effective DMT, new research shows.

“Owing to the vast number of available DMTs, not only understanding DMT performance but answering the question of what can come next if a patient needs to discontinue treatment due to safety or breakthrough disease is important,” said lead author Carrie M. Hersh, DO, of the Lou Ruvo Center for Brain Health, Cleveland Clinic, Las Vegas.

The study shows that, “patients transitioning from natalizumab to another high-efficacy therapy have better inflammatory and disability outcomes compared with those who de-escalate their therapy to a moderate-efficacy DMT,” she said.

Natalizumab (Tysabri) offers significant benefits in the treatment of relapsing forms of MS, however, its long-term use is associated with safety concerns, notably an increased risk of progressive multifocal leukoencephalopathy (PML). Although the risk can be reduced with a switch to a different DMT, the transition can have risks of its own, including a rebound of disease activity that could prove to be worse than the pre-natalizumab treatment period, and there is a lack of consensus on the safest avenues for switching to another DMT following discontinuation of natalizumab.

In research presented at the virtual meeting of the Consortium of Multiple Sclerosis Centers, Dr. Hersh and colleagues explored the issue in a real-world population of 556 patients discontinuing natalizumab at two MS centers. Of these, 270 switched to a moderate DMT (dimethyl fumarate, n = 130; or fingolimod, n = 140) and 130 switched to a highly effective DMT (ocrelizumab, n = 106; rituximab, n = 17; or alemtuzumab, n = 7).

Reasons for switching included a PML risk for 54.9%, breakthrough disease for 15.3%, and adverse effects for 17.3%.

At 24-month follow-up after the switch and after adjustment for propensity score matching, no differences were seen between the moderate and highly effective DMT groups in terms of the annualized relapse rate (ARR; P = 0.33) or the time to first relapse (P = 0.09).

However, significantly higher proportions of patients switching to moderate DMTs showed new T2 lesions (odds ratio, 2.15; P = .01), as well as new gadolinium-enhancing lesions (OR, 1.99; P = .02), and a 20% worsening of the timed 25-foot walk test (T25FW; OR, 1.83; P = .04) and 9-hole peg test (9-HPT; OR, 1.81; P = .04)

Those switching to moderate DMTs also had significantly lower rates of absence of disease activity over the 24 months (OR, 0.41, P = .004), and they had a higher risk of earlier time-to-first gadolinium-enhancing lesion (hazard ratio, 6.67, P = .002), compared with those switching to a high-efficacy DMT.

Other factors that have previously been shown to be associated with rebounds that are worse than pre-natalizumab treatment include washout periods that are longer than 3 months.

The authors noted that there were no significant differences between the groups in terms of mean washout duration, which were relatively short (moderate DMT, 1.4 months; highly effective treatment, 1.8 months; P = .34), In addition, there were no significant differences between the groups in terms of the average duration of natalizumab treatment.

Dr. Hersh speculated that the lack of ARR differences may reflect that the measure is not as objective as the more specific determinants of performance. “One could consider the comparable ARR as a little surprising, but relapse evaluation in a retrospective manner is limited,” she explained.

“Historically, radiographic markers of new inflammation via brain magnetic resonance imaging (MRI) and neuroperformance measures (T25FW and 9-HPT) are more objective compared to assessing clinical relapses, especially in a retrospective cohort where relapses cannot be validated by a central agency or the principal investigator. Therefore, one can surmise that patients transitioning from natalizumab to another high-efficacy DMT fare better than de-escalating treatment to a moderate-efficacy DMT.”

Dr. Hersh and team plan a larger, multicenter study to investigate the short- and long-term effects of post-natalizumab DMT sequencing to help validate the current findings.

Commenting on the research, Stephen Kamin, MD, professor, vice chair and chief of service, department of neurology, New Jersey Medical School, Newark, said the results are consistent with natalizumab’s general profile.

“In general, natalizumab has been used in patients with highly active disease, so I would expect fewer patients with no evidence of disease activity when switched to a moderately active drug rather than a highly active one,” he said in an interview.

Caveats of the findings include the trial’s observational nature, meaning potential confounding factors of baseline characteristics among patients who switched regimens are not known, noted Dr. Kamin, who was not involved with the study.

“Also, the patients were switched to a variety of drugs and even within a class there may be differences in outcome,” he explained.

Dr. Hersh reported consulting or research relationships with Biogen, Genentech, EMD Serono, Genzyme, Novartis, and PCORI. Dr. Kamin has received research support from Biogen, Novartis, and the Consortium of Multiple Sclerosis Centers.

This article first appeared on Medscape.com.

Patients with relapsing multiple sclerosis (MS) who switch from treatment with the highly effective disease-modifying therapy natalizumab to a moderate-efficacy DMT show an increased risk of disability accumulation and disease activity over 2 years compared with switching to another highly effective DMT, new research shows.

“Owing to the vast number of available DMTs, not only understanding DMT performance but answering the question of what can come next if a patient needs to discontinue treatment due to safety or breakthrough disease is important,” said lead author Carrie M. Hersh, DO, of the Lou Ruvo Center for Brain Health, Cleveland Clinic, Las Vegas.

The study shows that, “patients transitioning from natalizumab to another high-efficacy therapy have better inflammatory and disability outcomes compared with those who de-escalate their therapy to a moderate-efficacy DMT,” she said.

Natalizumab (Tysabri) offers significant benefits in the treatment of relapsing forms of MS, however, its long-term use is associated with safety concerns, notably an increased risk of progressive multifocal leukoencephalopathy (PML). Although the risk can be reduced with a switch to a different DMT, the transition can have risks of its own, including a rebound of disease activity that could prove to be worse than the pre-natalizumab treatment period, and there is a lack of consensus on the safest avenues for switching to another DMT following discontinuation of natalizumab.

In research presented at the virtual meeting of the Consortium of Multiple Sclerosis Centers, Dr. Hersh and colleagues explored the issue in a real-world population of 556 patients discontinuing natalizumab at two MS centers. Of these, 270 switched to a moderate DMT (dimethyl fumarate, n = 130; or fingolimod, n = 140) and 130 switched to a highly effective DMT (ocrelizumab, n = 106; rituximab, n = 17; or alemtuzumab, n = 7).

Reasons for switching included a PML risk for 54.9%, breakthrough disease for 15.3%, and adverse effects for 17.3%.

At 24-month follow-up after the switch and after adjustment for propensity score matching, no differences were seen between the moderate and highly effective DMT groups in terms of the annualized relapse rate (ARR; P = 0.33) or the time to first relapse (P = 0.09).

However, significantly higher proportions of patients switching to moderate DMTs showed new T2 lesions (odds ratio, 2.15; P = .01), as well as new gadolinium-enhancing lesions (OR, 1.99; P = .02), and a 20% worsening of the timed 25-foot walk test (T25FW; OR, 1.83; P = .04) and 9-hole peg test (9-HPT; OR, 1.81; P = .04)

Those switching to moderate DMTs also had significantly lower rates of absence of disease activity over the 24 months (OR, 0.41, P = .004), and they had a higher risk of earlier time-to-first gadolinium-enhancing lesion (hazard ratio, 6.67, P = .002), compared with those switching to a high-efficacy DMT.

Other factors that have previously been shown to be associated with rebounds that are worse than pre-natalizumab treatment include washout periods that are longer than 3 months.

The authors noted that there were no significant differences between the groups in terms of mean washout duration, which were relatively short (moderate DMT, 1.4 months; highly effective treatment, 1.8 months; P = .34), In addition, there were no significant differences between the groups in terms of the average duration of natalizumab treatment.

Dr. Hersh speculated that the lack of ARR differences may reflect that the measure is not as objective as the more specific determinants of performance. “One could consider the comparable ARR as a little surprising, but relapse evaluation in a retrospective manner is limited,” she explained.

“Historically, radiographic markers of new inflammation via brain magnetic resonance imaging (MRI) and neuroperformance measures (T25FW and 9-HPT) are more objective compared to assessing clinical relapses, especially in a retrospective cohort where relapses cannot be validated by a central agency or the principal investigator. Therefore, one can surmise that patients transitioning from natalizumab to another high-efficacy DMT fare better than de-escalating treatment to a moderate-efficacy DMT.”

Dr. Hersh and team plan a larger, multicenter study to investigate the short- and long-term effects of post-natalizumab DMT sequencing to help validate the current findings.

Commenting on the research, Stephen Kamin, MD, professor, vice chair and chief of service, department of neurology, New Jersey Medical School, Newark, said the results are consistent with natalizumab’s general profile.

“In general, natalizumab has been used in patients with highly active disease, so I would expect fewer patients with no evidence of disease activity when switched to a moderately active drug rather than a highly active one,” he said in an interview.

Caveats of the findings include the trial’s observational nature, meaning potential confounding factors of baseline characteristics among patients who switched regimens are not known, noted Dr. Kamin, who was not involved with the study.

“Also, the patients were switched to a variety of drugs and even within a class there may be differences in outcome,” he explained.

Dr. Hersh reported consulting or research relationships with Biogen, Genentech, EMD Serono, Genzyme, Novartis, and PCORI. Dr. Kamin has received research support from Biogen, Novartis, and the Consortium of Multiple Sclerosis Centers.

This article first appeared on Medscape.com.

Air pollution may be another environmental risk factor for developing multiple sclerosis (MS), new research suggests. A large cohort study of almost 550,000 individuals living in Italy showed that participants living in areas with high levels of pollutants had a significantly greater risk of developing MS than those who lived in areas with low levels of pollutants.

The findings further confirm a relationship between exposure to air pollutants and risk for MS that has been shown in previous research, said Roberto Bergamaschi, MD, PhD, director of the Multiple Sclerosis Center, IRCCS Mondino Foundation, Pavia, Italy.

“Countermeasures that cut air pollution can be important for public health, not only to reduce deaths related to cardiac and pulmonary diseases but also the risk of chronic autoimmune diseases such as MS,” Dr. Bergamaschi said.

The findings were presented at the Congress of the European Academy of Neurology (EAN) 2020, which transitioned to a virtual/online meeting because of the COVID-19 pandemic.
 

Toxic pollutants

Several environmental factors may trigger an abnormal immune response that manifests in MS. The most studied of these are low vitamin D level, cigarette smoking, and an unhealthy diet, Dr. Bergamaschi said. However, “other environmental factors deserve to be studied—pollution included,” he added.

Among the most toxic air pollutants are particulate matter (PM), which is a mixture of fine solid and liquid particles suspended in the earth’s atmosphere. PM may range from 2.5 microns (PM_2.5) to 10 microns (PM₁₀) in diameter.

The main sources of such pollutants are household and commercial heating (53%) and industrial activities (17%), followed by road vehicle and non–road vehicle use, agriculture, and electricity production.

The World Health Organization estimates that more than 3.2 million individuals worldwide die prematurely every year because of lung cancer, cardiovascular disease, and other diseases related to air pollutants, said Dr. Bergamaschi.

Epidemiologic research has uncovered a relationship between air pollution and MS. A large American study published in 2008 in Science of the Total Environment showed a significant association between MS prevalence and PM₁₀ levels (P < 0.001). Other studies have shown an increase in the number of clinical relapses of MS that were linked to air pollution.

The current investigators assessed the association between PM_2.5 levels and MS prevalence in the northern province of Pavia, which has a population of 547,251 individuals in 188 municipalities.
 

Peculiar features

Pavia is situated in a flat territory that encompasses the highly industrialized regions of Piedmont, Lombardy, Emilia-Romagna, and Veneto. It has a high level of anthropogenic emissions, or environmental pollutants, originating from human activity, Dr. Bergamaschi reported. The region also has “peculiar” geographical features that “favor the accumulation of pollutants,” such as the natural barrier of the Alps in the north and low wind speed, he said.

The researchers identified 927 individuals with MS (315 male and 612 female) in the province. The overall MS prevalence rate was 169.4 per 100,000 population (95% confidence interval [CI], 158.8 – 180.6), which is 10-fold higher than 50 years ago, Dr. Bergamaschi said. In addition, this MS prevalence is higher than that in the United States, which is about 150 per 100,000 population.

Using sophisticated Bayesian disease mapping, the investigators looked for clusters of MS. They also gathered emission data for PM_2.5 from 2010 to 2017 from the European Monitoring and Evaluation Programme database. They then divided the region on the basis of average winter concentrations of PM_2.5.

Three distinct lateral areas of air pollution were identified. The more northern region, which includes the large urban center of Milan, had the highest level of air pollution. Concentrations decreased the further south the investigators looked.

After adjusting for age, urbanization (population density), and deprivation index, results showed that living in areas with high levels of pollutants was associated with increased MS risk. When controlling for PM_2.5 pollution, participants in urban areas had an increased risk for MS compared with rural dwellers (relative risk [RR], 1.16; 95% CI, 1.04 – 1.30; P = 0.003)

Dr. Bergamaschi said it is unclear whether this risk is higher for certain types of MS. “To my knowledge, no study has analyzed possible relationships between MS phenotypes and air pollution,” he noted.
 

Vitamin D’s role?

Several mechanisms might help explain the relationship between air pollution and MS risk, he added. These include oxidative stress, which results in cell damage, inflammation, and proinflammatory cytokine release. Vitamin D also likely plays some role, Dr. Bergamaschi said. Upon penetrating the lower strata of the earth’s atmosphere, ultraviolet B radiation is absorbed and scattered by suspended pollutants.

Several studies have highlighted the correlation between living in a polluted area and vitamin D hypovitaminosis; “so air pollution can contribute to increasing the risk of MS by reducing vitamin D synthesis,” he said.

Recent research has also shown that air pollution is associated with a higher risk for other autoimmune disorders, including systemic lupus erythematosus, rheumatoid arthritis, and type 1 diabetes mellitus.

However, pollution alone is only part of the picture. MS prevalence in highly populated and polluted countries such as China and India is low, with no more than 30 to 40 cases per 100,000 population, Dr. Bergamaschi noted. “This discrepancy is explained by different genetic backgrounds. While Caucasians are particularly susceptible to MS, Asians are not,” he said.

Study limitations cited included a possible bias because the analysis did not include other possible contributing risk factors, particularly other pollutants, Dr. Bergamaschi said.

Commenting on the research, Lily Jung Henson, MD, chief of neurology at Piedmont Healthcare in Stockbridge, Georgia, said the findings provide “a fascinating glimpse” into possible causative factors for MS and warrant further investigation.

“This research also suggests other opportunities to look at, such as progression of the degree of air pollution and the incidence of MS over time,” said Dr. Henson, who was not involved with the study.

Drs. Bergamaschi and Dr. Henson have reported no relevant financial relationships.

This article first appeared on Medscape.com.

Air pollution may be another environmental risk factor for developing multiple sclerosis (MS), new research suggests. A large cohort study of almost 550,000 individuals living in Italy showed that participants living in areas with high levels of pollutants had a significantly greater risk of developing MS than those who lived in areas with low levels of pollutants.

The findings further confirm a relationship between exposure to air pollutants and risk for MS that has been shown in previous research, said Roberto Bergamaschi, MD, PhD, director of the Multiple Sclerosis Center, IRCCS Mondino Foundation, Pavia, Italy.

“Countermeasures that cut air pollution can be important for public health, not only to reduce deaths related to cardiac and pulmonary diseases but also the risk of chronic autoimmune diseases such as MS,” Dr. Bergamaschi said.

The findings were presented at the Congress of the European Academy of Neurology (EAN) 2020, which transitioned to a virtual/online meeting because of the COVID-19 pandemic.
 

Toxic pollutants

Several environmental factors may trigger an abnormal immune response that manifests in MS. The most studied of these are low vitamin D level, cigarette smoking, and an unhealthy diet, Dr. Bergamaschi said. However, “other environmental factors deserve to be studied—pollution included,” he added.

Among the most toxic air pollutants are particulate matter (PM), which is a mixture of fine solid and liquid particles suspended in the earth’s atmosphere. PM may range from 2.5 microns (PM_2.5) to 10 microns (PM₁₀) in diameter.

The main sources of such pollutants are household and commercial heating (53%) and industrial activities (17%), followed by road vehicle and non–road vehicle use, agriculture, and electricity production.

The World Health Organization estimates that more than 3.2 million individuals worldwide die prematurely every year because of lung cancer, cardiovascular disease, and other diseases related to air pollutants, said Dr. Bergamaschi.

Epidemiologic research has uncovered a relationship between air pollution and MS. A large American study published in 2008 in Science of the Total Environment showed a significant association between MS prevalence and PM₁₀ levels (P < 0.001). Other studies have shown an increase in the number of clinical relapses of MS that were linked to air pollution.

The current investigators assessed the association between PM_2.5 levels and MS prevalence in the northern province of Pavia, which has a population of 547,251 individuals in 188 municipalities.
 

Peculiar features

Pavia is situated in a flat territory that encompasses the highly industrialized regions of Piedmont, Lombardy, Emilia-Romagna, and Veneto. It has a high level of anthropogenic emissions, or environmental pollutants, originating from human activity, Dr. Bergamaschi reported. The region also has “peculiar” geographical features that “favor the accumulation of pollutants,” such as the natural barrier of the Alps in the north and low wind speed, he said.

The researchers identified 927 individuals with MS (315 male and 612 female) in the province. The overall MS prevalence rate was 169.4 per 100,000 population (95% confidence interval [CI], 158.8 – 180.6), which is 10-fold higher than 50 years ago, Dr. Bergamaschi said. In addition, this MS prevalence is higher than that in the United States, which is about 150 per 100,000 population.

Using sophisticated Bayesian disease mapping, the investigators looked for clusters of MS. They also gathered emission data for PM_2.5 from 2010 to 2017 from the European Monitoring and Evaluation Programme database. They then divided the region on the basis of average winter concentrations of PM_2.5.

Three distinct lateral areas of air pollution were identified. The more northern region, which includes the large urban center of Milan, had the highest level of air pollution. Concentrations decreased the further south the investigators looked.

After adjusting for age, urbanization (population density), and deprivation index, results showed that living in areas with high levels of pollutants was associated with increased MS risk. When controlling for PM_2.5 pollution, participants in urban areas had an increased risk for MS compared with rural dwellers (relative risk [RR], 1.16; 95% CI, 1.04 – 1.30; P = 0.003)

Dr. Bergamaschi said it is unclear whether this risk is higher for certain types of MS. “To my knowledge, no study has analyzed possible relationships between MS phenotypes and air pollution,” he noted.
 

Vitamin D’s role?

Several mechanisms might help explain the relationship between air pollution and MS risk, he added. These include oxidative stress, which results in cell damage, inflammation, and proinflammatory cytokine release. Vitamin D also likely plays some role, Dr. Bergamaschi said. Upon penetrating the lower strata of the earth’s atmosphere, ultraviolet B radiation is absorbed and scattered by suspended pollutants.

Several studies have highlighted the correlation between living in a polluted area and vitamin D hypovitaminosis; “so air pollution can contribute to increasing the risk of MS by reducing vitamin D synthesis,” he said.

Recent research has also shown that air pollution is associated with a higher risk for other autoimmune disorders, including systemic lupus erythematosus, rheumatoid arthritis, and type 1 diabetes mellitus.

However, pollution alone is only part of the picture. MS prevalence in highly populated and polluted countries such as China and India is low, with no more than 30 to 40 cases per 100,000 population, Dr. Bergamaschi noted. “This discrepancy is explained by different genetic backgrounds. While Caucasians are particularly susceptible to MS, Asians are not,” he said.

Study limitations cited included a possible bias because the analysis did not include other possible contributing risk factors, particularly other pollutants, Dr. Bergamaschi said.

Commenting on the research, Lily Jung Henson, MD, chief of neurology at Piedmont Healthcare in Stockbridge, Georgia, said the findings provide “a fascinating glimpse” into possible causative factors for MS and warrant further investigation.

“This research also suggests other opportunities to look at, such as progression of the degree of air pollution and the incidence of MS over time,” said Dr. Henson, who was not involved with the study.

Drs. Bergamaschi and Dr. Henson have reported no relevant financial relationships.

This article first appeared on Medscape.com.

Air pollution may be another environmental risk factor for developing multiple sclerosis (MS), new research suggests. A large cohort study of almost 550,000 individuals living in Italy showed that participants living in areas with high levels of pollutants had a significantly greater risk of developing MS than those who lived in areas with low levels of pollutants.

The findings further confirm a relationship between exposure to air pollutants and risk for MS that has been shown in previous research, said Roberto Bergamaschi, MD, PhD, director of the Multiple Sclerosis Center, IRCCS Mondino Foundation, Pavia, Italy.

“Countermeasures that cut air pollution can be important for public health, not only to reduce deaths related to cardiac and pulmonary diseases but also the risk of chronic autoimmune diseases such as MS,” Dr. Bergamaschi said.

The findings were presented at the Congress of the European Academy of Neurology (EAN) 2020, which transitioned to a virtual/online meeting because of the COVID-19 pandemic.
 

Toxic pollutants

Several environmental factors may trigger an abnormal immune response that manifests in MS. The most studied of these are low vitamin D level, cigarette smoking, and an unhealthy diet, Dr. Bergamaschi said. However, “other environmental factors deserve to be studied—pollution included,” he added.

Among the most toxic air pollutants are particulate matter (PM), which is a mixture of fine solid and liquid particles suspended in the earth’s atmosphere. PM may range from 2.5 microns (PM_2.5) to 10 microns (PM₁₀) in diameter.

The main sources of such pollutants are household and commercial heating (53%) and industrial activities (17%), followed by road vehicle and non–road vehicle use, agriculture, and electricity production.

The World Health Organization estimates that more than 3.2 million individuals worldwide die prematurely every year because of lung cancer, cardiovascular disease, and other diseases related to air pollutants, said Dr. Bergamaschi.

Epidemiologic research has uncovered a relationship between air pollution and MS. A large American study published in 2008 in Science of the Total Environment showed a significant association between MS prevalence and PM₁₀ levels (P < 0.001). Other studies have shown an increase in the number of clinical relapses of MS that were linked to air pollution.

The current investigators assessed the association between PM_2.5 levels and MS prevalence in the northern province of Pavia, which has a population of 547,251 individuals in 188 municipalities.
 

Peculiar features

Pavia is situated in a flat territory that encompasses the highly industrialized regions of Piedmont, Lombardy, Emilia-Romagna, and Veneto. It has a high level of anthropogenic emissions, or environmental pollutants, originating from human activity, Dr. Bergamaschi reported. The region also has “peculiar” geographical features that “favor the accumulation of pollutants,” such as the natural barrier of the Alps in the north and low wind speed, he said.

The researchers identified 927 individuals with MS (315 male and 612 female) in the province. The overall MS prevalence rate was 169.4 per 100,000 population (95% confidence interval [CI], 158.8 – 180.6), which is 10-fold higher than 50 years ago, Dr. Bergamaschi said. In addition, this MS prevalence is higher than that in the United States, which is about 150 per 100,000 population.

Using sophisticated Bayesian disease mapping, the investigators looked for clusters of MS. They also gathered emission data for PM_2.5 from 2010 to 2017 from the European Monitoring and Evaluation Programme database. They then divided the region on the basis of average winter concentrations of PM_2.5.

Three distinct lateral areas of air pollution were identified. The more northern region, which includes the large urban center of Milan, had the highest level of air pollution. Concentrations decreased the further south the investigators looked.

After adjusting for age, urbanization (population density), and deprivation index, results showed that living in areas with high levels of pollutants was associated with increased MS risk. When controlling for PM_2.5 pollution, participants in urban areas had an increased risk for MS compared with rural dwellers (relative risk [RR], 1.16; 95% CI, 1.04 – 1.30; P = 0.003)

Dr. Bergamaschi said it is unclear whether this risk is higher for certain types of MS. “To my knowledge, no study has analyzed possible relationships between MS phenotypes and air pollution,” he noted.
 

Vitamin D’s role?

Several mechanisms might help explain the relationship between air pollution and MS risk, he added. These include oxidative stress, which results in cell damage, inflammation, and proinflammatory cytokine release. Vitamin D also likely plays some role, Dr. Bergamaschi said. Upon penetrating the lower strata of the earth’s atmosphere, ultraviolet B radiation is absorbed and scattered by suspended pollutants.

Several studies have highlighted the correlation between living in a polluted area and vitamin D hypovitaminosis; “so air pollution can contribute to increasing the risk of MS by reducing vitamin D synthesis,” he said.

Recent research has also shown that air pollution is associated with a higher risk for other autoimmune disorders, including systemic lupus erythematosus, rheumatoid arthritis, and type 1 diabetes mellitus.

However, pollution alone is only part of the picture. MS prevalence in highly populated and polluted countries such as China and India is low, with no more than 30 to 40 cases per 100,000 population, Dr. Bergamaschi noted. “This discrepancy is explained by different genetic backgrounds. While Caucasians are particularly susceptible to MS, Asians are not,” he said.

Study limitations cited included a possible bias because the analysis did not include other possible contributing risk factors, particularly other pollutants, Dr. Bergamaschi said.

Commenting on the research, Lily Jung Henson, MD, chief of neurology at Piedmont Healthcare in Stockbridge, Georgia, said the findings provide “a fascinating glimpse” into possible causative factors for MS and warrant further investigation.

“This research also suggests other opportunities to look at, such as progression of the degree of air pollution and the incidence of MS over time,” said Dr. Henson, who was not involved with the study.

Drs. Bergamaschi and Dr. Henson have reported no relevant financial relationships.

This article first appeared on Medscape.com.

During the deadliest wildfire in California’s history in 2018, dermatology clinics 175 miles away at the University of California, San Francisco, experienced an increase in the number of pediatric and adult visits for pruritus and atopic dermatitis associated with air pollution created from the wildfire, according to research presented at the annual meeting of the Society for Investigative Dermatology, held virtually.

In patients with and without atopic dermatitis (AD), “acute exposure to poor air quality associated with a wildfire event can increase the number of visits for itch,” Raj Fadadu, a medical student at the University of California, San Francisco, said in his presentation.

Not many studies have examined this potential association, but includes those that have found significant positive associations between exposure to air pollution and pruritus, the development of AD, and exacerbation of AD (J Allergy Clin Immunol. 2014 Nov;134[5]:993-9). Another study found outpatient visits for patients with eczema and dermatitis in Beijing increased as the level of particulate matter, nitrogen dioxide, and sulfur dioxide concentrations increased (Environ Sci Process Impacts. 2019 Jan 23;21[1]:163-73).

Mr. Faduda and colleagues set out to determine whether the number of appointments for and severity of skin disease increased as a result of the 2018 Camp Fire, which started in Paradise, Calif., using measures of air pollution and clinic visits in years where California did not experience a wildfire event as controls. Using the National Oceanic and Atmospheric Administration Hazard Mapping System for fire and smoke, the researchers graphed smoke plume density scores and particulate matter (PM_2.5) concentrations in the area. They then calculated the number of UCSF dermatology clinic visits for AD/eczema, and measured severity of skin disease with appointments for itch symptoms, and the number of prescribed medications during that time using ICD-10 codes.

The Camp Fire rapidly spread over a period of 17 days, between Nov. 8 and 25, 2018, during which time, PM_2.5 particulate matter concentrations increased 10-fold, while the NOAA smoke plume density score sharply increased. More pediatric and adult patients also seemed to be visiting clinics during this time, compared with several weeks before and several weeks after the fire, prompting a more expanded analysis of this signal, Mr. Fadadu said.

He and his coinvestigators compared data between October 2015 and February 2016 – a period of time where there were no wildfires in California – with data in 2018, when the Camp Fire occurred. They collected data on 3,448 adults and 699 children across 3 years with a total of 5,539 adult appointments for AD, 924 pediatric appointments for AD, 1,319 adult itch appointments, and 294 pediatric itch appointments. Cumulative and exposure lags were used to measure the effect of the wildfire in a Poisson regression analysis.

They found that, during the wildfire, pediatric AD weekly clinic visits were 1.75 times higher (95% confidence interval, 1.21-2.50) and pediatric itch visits were 2.10 times higher (95% CI, 1.44-3.00), compared with weeks where there was no fire. During the wildfire, pediatric AD clinic visits increased by 8% (rate ratio, 1.08; 95% CI, 1.04-1.12) per 10 mcg/m³ increase in PM_2.5 concentration.

In adults, clinic visits for AD were 1.28 times higher (95% CI, 1.08-1.51) during the wildfire, compared with nonfire weeks. While there was a positive association between pollution exposure and adult AD, “this effect is less than what we observed” for pediatric AD visits, said Mr. Fadadu. Air pollution was positively associated with the development of itch symptoms in adults and more prescriptions for AD medications, but the results were not statistically significant.

“This may be explained by the fact that 80% of pediatric itch patients carried an AD diagnosis, while in contrast, only half of the adult itch patients also have a diagnosis of AD,” he said.

While there are several possible limitations of the research, including assessment of air pollution exposure, Mr. Fadadu said, “these results can inform how dermatologists counsel patients during future episodes of poor air quality, as well as expand comprehension of the broader health effects of climate change that can significantly impact quality of life.”

This study was funded by the UCSF Summer Explore Fellowship, Marguerite Schoeneman Award, and Joint Medical Program Thesis Grant.

During the deadliest wildfire in California’s history in 2018, dermatology clinics 175 miles away at the University of California, San Francisco, experienced an increase in the number of pediatric and adult visits for pruritus and atopic dermatitis associated with air pollution created from the wildfire, according to research presented at the annual meeting of the Society for Investigative Dermatology, held virtually.

In patients with and without atopic dermatitis (AD), “acute exposure to poor air quality associated with a wildfire event can increase the number of visits for itch,” Raj Fadadu, a medical student at the University of California, San Francisco, said in his presentation.

Not many studies have examined this potential association, but includes those that have found significant positive associations between exposure to air pollution and pruritus, the development of AD, and exacerbation of AD (J Allergy Clin Immunol. 2014 Nov;134[5]:993-9). Another study found outpatient visits for patients with eczema and dermatitis in Beijing increased as the level of particulate matter, nitrogen dioxide, and sulfur dioxide concentrations increased (Environ Sci Process Impacts. 2019 Jan 23;21[1]:163-73).

Mr. Faduda and colleagues set out to determine whether the number of appointments for and severity of skin disease increased as a result of the 2018 Camp Fire, which started in Paradise, Calif., using measures of air pollution and clinic visits in years where California did not experience a wildfire event as controls. Using the National Oceanic and Atmospheric Administration Hazard Mapping System for fire and smoke, the researchers graphed smoke plume density scores and particulate matter (PM_2.5) concentrations in the area. They then calculated the number of UCSF dermatology clinic visits for AD/eczema, and measured severity of skin disease with appointments for itch symptoms, and the number of prescribed medications during that time using ICD-10 codes.

The Camp Fire rapidly spread over a period of 17 days, between Nov. 8 and 25, 2018, during which time, PM_2.5 particulate matter concentrations increased 10-fold, while the NOAA smoke plume density score sharply increased. More pediatric and adult patients also seemed to be visiting clinics during this time, compared with several weeks before and several weeks after the fire, prompting a more expanded analysis of this signal, Mr. Fadadu said.

He and his coinvestigators compared data between October 2015 and February 2016 – a period of time where there were no wildfires in California – with data in 2018, when the Camp Fire occurred. They collected data on 3,448 adults and 699 children across 3 years with a total of 5,539 adult appointments for AD, 924 pediatric appointments for AD, 1,319 adult itch appointments, and 294 pediatric itch appointments. Cumulative and exposure lags were used to measure the effect of the wildfire in a Poisson regression analysis.

They found that, during the wildfire, pediatric AD weekly clinic visits were 1.75 times higher (95% confidence interval, 1.21-2.50) and pediatric itch visits were 2.10 times higher (95% CI, 1.44-3.00), compared with weeks where there was no fire. During the wildfire, pediatric AD clinic visits increased by 8% (rate ratio, 1.08; 95% CI, 1.04-1.12) per 10 mcg/m³ increase in PM_2.5 concentration.

In adults, clinic visits for AD were 1.28 times higher (95% CI, 1.08-1.51) during the wildfire, compared with nonfire weeks. While there was a positive association between pollution exposure and adult AD, “this effect is less than what we observed” for pediatric AD visits, said Mr. Fadadu. Air pollution was positively associated with the development of itch symptoms in adults and more prescriptions for AD medications, but the results were not statistically significant.

“This may be explained by the fact that 80% of pediatric itch patients carried an AD diagnosis, while in contrast, only half of the adult itch patients also have a diagnosis of AD,” he said.

While there are several possible limitations of the research, including assessment of air pollution exposure, Mr. Fadadu said, “these results can inform how dermatologists counsel patients during future episodes of poor air quality, as well as expand comprehension of the broader health effects of climate change that can significantly impact quality of life.”

This study was funded by the UCSF Summer Explore Fellowship, Marguerite Schoeneman Award, and Joint Medical Program Thesis Grant.

During the deadliest wildfire in California’s history in 2018, dermatology clinics 175 miles away at the University of California, San Francisco, experienced an increase in the number of pediatric and adult visits for pruritus and atopic dermatitis associated with air pollution created from the wildfire, according to research presented at the annual meeting of the Society for Investigative Dermatology, held virtually.

In patients with and without atopic dermatitis (AD), “acute exposure to poor air quality associated with a wildfire event can increase the number of visits for itch,” Raj Fadadu, a medical student at the University of California, San Francisco, said in his presentation.

Not many studies have examined this potential association, but includes those that have found significant positive associations between exposure to air pollution and pruritus, the development of AD, and exacerbation of AD (J Allergy Clin Immunol. 2014 Nov;134[5]:993-9). Another study found outpatient visits for patients with eczema and dermatitis in Beijing increased as the level of particulate matter, nitrogen dioxide, and sulfur dioxide concentrations increased (Environ Sci Process Impacts. 2019 Jan 23;21[1]:163-73).

Mr. Faduda and colleagues set out to determine whether the number of appointments for and severity of skin disease increased as a result of the 2018 Camp Fire, which started in Paradise, Calif., using measures of air pollution and clinic visits in years where California did not experience a wildfire event as controls. Using the National Oceanic and Atmospheric Administration Hazard Mapping System for fire and smoke, the researchers graphed smoke plume density scores and particulate matter (PM_2.5) concentrations in the area. They then calculated the number of UCSF dermatology clinic visits for AD/eczema, and measured severity of skin disease with appointments for itch symptoms, and the number of prescribed medications during that time using ICD-10 codes.

The Camp Fire rapidly spread over a period of 17 days, between Nov. 8 and 25, 2018, during which time, PM_2.5 particulate matter concentrations increased 10-fold, while the NOAA smoke plume density score sharply increased. More pediatric and adult patients also seemed to be visiting clinics during this time, compared with several weeks before and several weeks after the fire, prompting a more expanded analysis of this signal, Mr. Fadadu said.

He and his coinvestigators compared data between October 2015 and February 2016 – a period of time where there were no wildfires in California – with data in 2018, when the Camp Fire occurred. They collected data on 3,448 adults and 699 children across 3 years with a total of 5,539 adult appointments for AD, 924 pediatric appointments for AD, 1,319 adult itch appointments, and 294 pediatric itch appointments. Cumulative and exposure lags were used to measure the effect of the wildfire in a Poisson regression analysis.

They found that, during the wildfire, pediatric AD weekly clinic visits were 1.75 times higher (95% confidence interval, 1.21-2.50) and pediatric itch visits were 2.10 times higher (95% CI, 1.44-3.00), compared with weeks where there was no fire. During the wildfire, pediatric AD clinic visits increased by 8% (rate ratio, 1.08; 95% CI, 1.04-1.12) per 10 mcg/m³ increase in PM_2.5 concentration.

In adults, clinic visits for AD were 1.28 times higher (95% CI, 1.08-1.51) during the wildfire, compared with nonfire weeks. While there was a positive association between pollution exposure and adult AD, “this effect is less than what we observed” for pediatric AD visits, said Mr. Fadadu. Air pollution was positively associated with the development of itch symptoms in adults and more prescriptions for AD medications, but the results were not statistically significant.

“This may be explained by the fact that 80% of pediatric itch patients carried an AD diagnosis, while in contrast, only half of the adult itch patients also have a diagnosis of AD,” he said.

While there are several possible limitations of the research, including assessment of air pollution exposure, Mr. Fadadu said, “these results can inform how dermatologists counsel patients during future episodes of poor air quality, as well as expand comprehension of the broader health effects of climate change that can significantly impact quality of life.”

This study was funded by the UCSF Summer Explore Fellowship, Marguerite Schoeneman Award, and Joint Medical Program Thesis Grant.

Nonpharmacologic recommendations for ankylosing spondylitis aren’t often followed by rheumatologists in the Boston-based Partners Healthcare system, and probably elsewhere, according to a review presented at the virtual annual meeting of the Spondyloarthritis Research and Treatment Network (SPARTAN).

The American College of Rheumatology, Spondylitis Association of America, and SPARTAN released joint guidelines for ankylosing spondylitis (AS) and nonradiographic axial spondyloarthritis in 2016. Nonpharmacologic recommendations for AS included regular disease activity monitoring using a validated measure and C-reactive protein or erythrocyte sedimentation rate; physical therapy (PT) or home back exercises; and screening for osteoporosis with dual x-ray absorptiometry (DXA) scanning.

However, “the extent to which these recommendations are followed in clinical practice is unknown,” said lead investigator Akash Patel, of the Brigham and Women’s Hospital Division of Rheumatology, Immunology, and Allergy, in Boston.

To find out, the team reviewed electronic records for 304 AS patients who had 564 rheumatology clinic visits with Brigham and Women’s and other Partners Healthcare physicians from July 1, 2016, to June 30, 2019.

Records documented DXA scans in less than 20% of visits. PT was documented in only 9% of visits, and home back exercise in just 7%. Inflammatory marker measurement was documented in about half of visits, and disease activity was measured in only 17%.

Comparing the first year of the study – right after the recommendations came out – to the third year, the team found just an 8% increase in disease activity documentation, and about a 3% increase in documentation of PT and back exercises.

In short, the recommendations “were performed at low frequencies in this study population,” Mr. Patel said at the meeting, which was held online this year because of the COVID-19 pandemic.

It’s unclear what’s going on. Perhaps some physicians disagree with the 2016 advice – the regular monitoring of disease activity, after all, was a conditional recommendation based on low-quality evidence. Other times, physicians might not have had enough time to talk about exercise or draw blood for AS biomarkers. Maybe they didn’t bring up PT when they knew their patients couldn’t afford the out-of-pocket cost.

Whatever the case, future iterations of the guidelines should include advice on how to implement them. “We believe that including some sort of strategy for rheumatologists may help increase compliance,” Mr. Patel said.

A member of the online viewing audience suggested that the problem may be widespread in rheumatology. "I think if we did this at my institution,” for example, “it would also look abysmal. I think we all just suck at this,” the attendee said.*

Mr. Patel and his team presented the results to Brigham and Women’s rheumatologists in February 2020, but it’s too early to tell if it made a difference.

It was a typical AS cohort. Almost three-quarters of the subjects were men; the average age was 50 years old; and the diagnosis was made by imaging. The majority of patients were HLA-B27 positive, and over one-third had a history of uveitis.

The study’s funding source and disclosures – if any – weren’t reported.

*Correction, 6/3/2020: A previous version of this story misattributed this quote.

[email protected]

SOURCE: Patel A et al. SPARTAN 2020 abstract session May 15.

Nonpharmacologic recommendations for ankylosing spondylitis aren’t often followed by rheumatologists in the Boston-based Partners Healthcare system, and probably elsewhere, according to a review presented at the virtual annual meeting of the Spondyloarthritis Research and Treatment Network (SPARTAN).

The American College of Rheumatology, Spondylitis Association of America, and SPARTAN released joint guidelines for ankylosing spondylitis (AS) and nonradiographic axial spondyloarthritis in 2016. Nonpharmacologic recommendations for AS included regular disease activity monitoring using a validated measure and C-reactive protein or erythrocyte sedimentation rate; physical therapy (PT) or home back exercises; and screening for osteoporosis with dual x-ray absorptiometry (DXA) scanning.

However, “the extent to which these recommendations are followed in clinical practice is unknown,” said lead investigator Akash Patel, of the Brigham and Women’s Hospital Division of Rheumatology, Immunology, and Allergy, in Boston.

To find out, the team reviewed electronic records for 304 AS patients who had 564 rheumatology clinic visits with Brigham and Women’s and other Partners Healthcare physicians from July 1, 2016, to June 30, 2019.

Records documented DXA scans in less than 20% of visits. PT was documented in only 9% of visits, and home back exercise in just 7%. Inflammatory marker measurement was documented in about half of visits, and disease activity was measured in only 17%.

Comparing the first year of the study – right after the recommendations came out – to the third year, the team found just an 8% increase in disease activity documentation, and about a 3% increase in documentation of PT and back exercises.

In short, the recommendations “were performed at low frequencies in this study population,” Mr. Patel said at the meeting, which was held online this year because of the COVID-19 pandemic.

It’s unclear what’s going on. Perhaps some physicians disagree with the 2016 advice – the regular monitoring of disease activity, after all, was a conditional recommendation based on low-quality evidence. Other times, physicians might not have had enough time to talk about exercise or draw blood for AS biomarkers. Maybe they didn’t bring up PT when they knew their patients couldn’t afford the out-of-pocket cost.

Whatever the case, future iterations of the guidelines should include advice on how to implement them. “We believe that including some sort of strategy for rheumatologists may help increase compliance,” Mr. Patel said.

A member of the online viewing audience suggested that the problem may be widespread in rheumatology. "I think if we did this at my institution,” for example, “it would also look abysmal. I think we all just suck at this,” the attendee said.*

Mr. Patel and his team presented the results to Brigham and Women’s rheumatologists in February 2020, but it’s too early to tell if it made a difference.

It was a typical AS cohort. Almost three-quarters of the subjects were men; the average age was 50 years old; and the diagnosis was made by imaging. The majority of patients were HLA-B27 positive, and over one-third had a history of uveitis.

The study’s funding source and disclosures – if any – weren’t reported.

*Correction, 6/3/2020: A previous version of this story misattributed this quote.

[email protected]

SOURCE: Patel A et al. SPARTAN 2020 abstract session May 15.

Nonpharmacologic recommendations for ankylosing spondylitis aren’t often followed by rheumatologists in the Boston-based Partners Healthcare system, and probably elsewhere, according to a review presented at the virtual annual meeting of the Spondyloarthritis Research and Treatment Network (SPARTAN).

The American College of Rheumatology, Spondylitis Association of America, and SPARTAN released joint guidelines for ankylosing spondylitis (AS) and nonradiographic axial spondyloarthritis in 2016. Nonpharmacologic recommendations for AS included regular disease activity monitoring using a validated measure and C-reactive protein or erythrocyte sedimentation rate; physical therapy (PT) or home back exercises; and screening for osteoporosis with dual x-ray absorptiometry (DXA) scanning.

However, “the extent to which these recommendations are followed in clinical practice is unknown,” said lead investigator Akash Patel, of the Brigham and Women’s Hospital Division of Rheumatology, Immunology, and Allergy, in Boston.

To find out, the team reviewed electronic records for 304 AS patients who had 564 rheumatology clinic visits with Brigham and Women’s and other Partners Healthcare physicians from July 1, 2016, to June 30, 2019.

Records documented DXA scans in less than 20% of visits. PT was documented in only 9% of visits, and home back exercise in just 7%. Inflammatory marker measurement was documented in about half of visits, and disease activity was measured in only 17%.

Comparing the first year of the study – right after the recommendations came out – to the third year, the team found just an 8% increase in disease activity documentation, and about a 3% increase in documentation of PT and back exercises.

In short, the recommendations “were performed at low frequencies in this study population,” Mr. Patel said at the meeting, which was held online this year because of the COVID-19 pandemic.

It’s unclear what’s going on. Perhaps some physicians disagree with the 2016 advice – the regular monitoring of disease activity, after all, was a conditional recommendation based on low-quality evidence. Other times, physicians might not have had enough time to talk about exercise or draw blood for AS biomarkers. Maybe they didn’t bring up PT when they knew their patients couldn’t afford the out-of-pocket cost.

Whatever the case, future iterations of the guidelines should include advice on how to implement them. “We believe that including some sort of strategy for rheumatologists may help increase compliance,” Mr. Patel said.

A member of the online viewing audience suggested that the problem may be widespread in rheumatology. "I think if we did this at my institution,” for example, “it would also look abysmal. I think we all just suck at this,” the attendee said.*

Mr. Patel and his team presented the results to Brigham and Women’s rheumatologists in February 2020, but it’s too early to tell if it made a difference.

It was a typical AS cohort. Almost three-quarters of the subjects were men; the average age was 50 years old; and the diagnosis was made by imaging. The majority of patients were HLA-B27 positive, and over one-third had a history of uveitis.

The study’s funding source and disclosures – if any – weren’t reported.

*Correction, 6/3/2020: A previous version of this story misattributed this quote.

[email protected]

SOURCE: Patel A et al. SPARTAN 2020 abstract session May 15.

Substance use disorder and its daily consequences take no breaks even during a pandemic. The stressors created by COVID-19, including deaths of loved ones and the disruptions to normal life from policies aimed at flattening the curve, seem to have increased substance use.

Courtesy Dr. Keji Fagbemi

I practice as a hospitalist with an internal medicine background and specialty in addiction medicine at BronxCare Health System’s inpatient detoxification unit, a 24/7, 20-bed medically-supervised unit in South Bronx in New York City. It is one of the comprehensive services provided by the BronxCare’s life recovery center and addiction services, which also includes an outpatient clinic, opioid treatment program, inpatient rehab, and a half-way house. Inpatient detoxification units like ours are designed to treat serious addictions and chemical dependency and prevent and treat life-threatening withdrawal symptoms and signs or complications. Our patients come from all over the city and its adjoining suburbs, including from emergency room referrals, referral clinics, courts and the justice system, walk-ins, and self-referrals.

At a time when many inpatient detoxification units within the city were temporarily closed due to fear of inpatient spread of the virus or to provide extra COVID beds in anticipation for the peak surge, we have been able to provide a needed service. In fact, several other inpatient detoxification programs within the city have been able to refer their patients to our facility.

Individuals with substance use disorder have historically been a vulnerable and underserved population and possess high risk for multiple health problems as well as preexisting conditions. Many have limited life options financially, educationally, and with housing, and encounter barriers to accessing primary health care services, including preventive services. The introduction of the COVID-19 pandemic into these patients’ precarious health situations only made things worse as many of the limited resources for patients with substance use disorder were diverted to battling the pandemic. Numerous inpatient and outpatient addiction services, for example, were temporarily shut down. This has led to an increase in domestic violence, and psychiatric decompensation, including psychosis, suicidal attempts, and worsening of medical comorbidities in these patients.

Our wake-up call came when the first case of COVID-19 was confirmed in New York in early March. Within a short period of time the state became the epicenter for COVID-19. With the projection of millions of cases being positive and the number of new cases doubling every third day at the onset in New York City, we knew we had a battle brewing and needed to radically transform our mode of operation fast.

Our first task was to ensure the safety of our patients and the dedicated health workers attending to them. Instead of shutting down we decided to focus on education, screening, mask usage, social distancing, and intensifying hygiene. We streamlined the patient point of entry through one screening site, while also brushing up on our history-taking to intently screen for COVID-19. This included not just focusing on travels from China, but from Europe and other parts of the world.

Yes, we did ask patients about cough, fever, shortness of breath or difficulty breathing, feeling fatigued, severe body ache, and possible contact with someone who is sick or has traveled overseas. But we were also attuned to the increased rate of community spread and the presentation of other symptoms, such as loss of taste and smell, early in the process. Hence we were able to triage patients with suspected cases to the appropriate sections of the hospital for further screening, testing, and evaluation, instead of having those patients admitted to the detox unit.

Courtesy Dr. Keji Fagbemi

Dr. Fagbemi is a hospitalist at BronxCare Health System, a not-for-profit health and teaching hospital system serving South and Central Bronx in New York. He has no conflicts of interest to disclose.

Substance use disorder and its daily consequences take no breaks even during a pandemic. The stressors created by COVID-19, including deaths of loved ones and the disruptions to normal life from policies aimed at flattening the curve, seem to have increased substance use.

Courtesy Dr. Keji Fagbemi

I practice as a hospitalist with an internal medicine background and specialty in addiction medicine at BronxCare Health System’s inpatient detoxification unit, a 24/7, 20-bed medically-supervised unit in South Bronx in New York City. It is one of the comprehensive services provided by the BronxCare’s life recovery center and addiction services, which also includes an outpatient clinic, opioid treatment program, inpatient rehab, and a half-way house. Inpatient detoxification units like ours are designed to treat serious addictions and chemical dependency and prevent and treat life-threatening withdrawal symptoms and signs or complications. Our patients come from all over the city and its adjoining suburbs, including from emergency room referrals, referral clinics, courts and the justice system, walk-ins, and self-referrals.

At a time when many inpatient detoxification units within the city were temporarily closed due to fear of inpatient spread of the virus or to provide extra COVID beds in anticipation for the peak surge, we have been able to provide a needed service. In fact, several other inpatient detoxification programs within the city have been able to refer their patients to our facility.

Individuals with substance use disorder have historically been a vulnerable and underserved population and possess high risk for multiple health problems as well as preexisting conditions. Many have limited life options financially, educationally, and with housing, and encounter barriers to accessing primary health care services, including preventive services. The introduction of the COVID-19 pandemic into these patients’ precarious health situations only made things worse as many of the limited resources for patients with substance use disorder were diverted to battling the pandemic. Numerous inpatient and outpatient addiction services, for example, were temporarily shut down. This has led to an increase in domestic violence, and psychiatric decompensation, including psychosis, suicidal attempts, and worsening of medical comorbidities in these patients.

Our wake-up call came when the first case of COVID-19 was confirmed in New York in early March. Within a short period of time the state became the epicenter for COVID-19. With the projection of millions of cases being positive and the number of new cases doubling every third day at the onset in New York City, we knew we had a battle brewing and needed to radically transform our mode of operation fast.

Our first task was to ensure the safety of our patients and the dedicated health workers attending to them. Instead of shutting down we decided to focus on education, screening, mask usage, social distancing, and intensifying hygiene. We streamlined the patient point of entry through one screening site, while also brushing up on our history-taking to intently screen for COVID-19. This included not just focusing on travels from China, but from Europe and other parts of the world.

Yes, we did ask patients about cough, fever, shortness of breath or difficulty breathing, feeling fatigued, severe body ache, and possible contact with someone who is sick or has traveled overseas. But we were also attuned to the increased rate of community spread and the presentation of other symptoms, such as loss of taste and smell, early in the process. Hence we were able to triage patients with suspected cases to the appropriate sections of the hospital for further screening, testing, and evaluation, instead of having those patients admitted to the detox unit.

Courtesy Dr. Keji Fagbemi

Dr. Fagbemi is a hospitalist at BronxCare Health System, a not-for-profit health and teaching hospital system serving South and Central Bronx in New York. He has no conflicts of interest to disclose.

Substance use disorder and its daily consequences take no breaks even during a pandemic. The stressors created by COVID-19, including deaths of loved ones and the disruptions to normal life from policies aimed at flattening the curve, seem to have increased substance use.

Courtesy Dr. Keji Fagbemi

I practice as a hospitalist with an internal medicine background and specialty in addiction medicine at BronxCare Health System’s inpatient detoxification unit, a 24/7, 20-bed medically-supervised unit in South Bronx in New York City. It is one of the comprehensive services provided by the BronxCare’s life recovery center and addiction services, which also includes an outpatient clinic, opioid treatment program, inpatient rehab, and a half-way house. Inpatient detoxification units like ours are designed to treat serious addictions and chemical dependency and prevent and treat life-threatening withdrawal symptoms and signs or complications. Our patients come from all over the city and its adjoining suburbs, including from emergency room referrals, referral clinics, courts and the justice system, walk-ins, and self-referrals.

At a time when many inpatient detoxification units within the city were temporarily closed due to fear of inpatient spread of the virus or to provide extra COVID beds in anticipation for the peak surge, we have been able to provide a needed service. In fact, several other inpatient detoxification programs within the city have been able to refer their patients to our facility.

Individuals with substance use disorder have historically been a vulnerable and underserved population and possess high risk for multiple health problems as well as preexisting conditions. Many have limited life options financially, educationally, and with housing, and encounter barriers to accessing primary health care services, including preventive services. The introduction of the COVID-19 pandemic into these patients’ precarious health situations only made things worse as many of the limited resources for patients with substance use disorder were diverted to battling the pandemic. Numerous inpatient and outpatient addiction services, for example, were temporarily shut down. This has led to an increase in domestic violence, and psychiatric decompensation, including psychosis, suicidal attempts, and worsening of medical comorbidities in these patients.

Our wake-up call came when the first case of COVID-19 was confirmed in New York in early March. Within a short period of time the state became the epicenter for COVID-19. With the projection of millions of cases being positive and the number of new cases doubling every third day at the onset in New York City, we knew we had a battle brewing and needed to radically transform our mode of operation fast.

Our first task was to ensure the safety of our patients and the dedicated health workers attending to them. Instead of shutting down we decided to focus on education, screening, mask usage, social distancing, and intensifying hygiene. We streamlined the patient point of entry through one screening site, while also brushing up on our history-taking to intently screen for COVID-19. This included not just focusing on travels from China, but from Europe and other parts of the world.

Yes, we did ask patients about cough, fever, shortness of breath or difficulty breathing, feeling fatigued, severe body ache, and possible contact with someone who is sick or has traveled overseas. But we were also attuned to the increased rate of community spread and the presentation of other symptoms, such as loss of taste and smell, early in the process. Hence we were able to triage patients with suspected cases to the appropriate sections of the hospital for further screening, testing, and evaluation, instead of having those patients admitted to the detox unit.

Courtesy Dr. Keji Fagbemi

Dr. Fagbemi is a hospitalist at BronxCare Health System, a not-for-profit health and teaching hospital system serving South and Central Bronx in New York. He has no conflicts of interest to disclose.