GVHD prophylaxis: Similar outcomes with PTCy and ATG

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A newer regimen was no more effective than an older regimen when both were compared for graft versus host disease (GVHD) prophylaxis in patients who underwent reduced-intensity conditioning followed by a hematopoietic stem cell transplant (HSCT) from a 10/10 HLA-matched related or unrelated donor.

These results come from a multicenter randomized trial that compared posttransplant cyclophosphamide (PTCy) to antithymocyte globulin (ATG), which has been used for decades.

There were no significant differences between the two in either disease-free or overall survival, GVHD-free relapse-free survival (GRFS), or nonrelapse mortality, reported lead investigator Eolia Brissot, MD, of Hôpital Saint-Antoine, Sorbonne University, Paris.

Her presentation was judged ‘top abstract’ at the annual meeting of the European Society for Blood and Marrow Transplantation (EBMT), held virtually because of the pandemic.

ATG has been used for more than 30 years for GVHD prophylaxis in allogeneic HSCT. In contrast, PTCy is the new kid on the block, developed to facilitate haploidentical transplants using unmanipulated bone marrow cells to act as a method for selective allodepletion in vivo.

“PTCy [has proved] to be effective in preventing both acute and chronic GVHD,” Dr. Brissot said. “However, controversial outcome data remain when comparing PTCy and ATG according to the type of donors.”

Until now, she noted, there have been no prospective randomized data  available for patients with donors (related or unrelated) that have 10 of 10 matched human leukocyte antigen (HLA) alleles. Hence, these were the patients studied in this latest trial, and in this population both regimens showed similar outcomes.

A bone marrow transplant specialist who was not involved in the study said that it’s a good first step.

“This is an important study to gain preliminary data to design a larger, subsequent phase 3 study,” said Zachariah DeFilipp, MD, of Mass General Cancer Center in Boston.

“The use of ATG as part of GVHD prophylaxis is common at many centers, especially in Europe, “ he explained. “The use of posttransplant cyclophosphamide is being expanded to more settings with transplant, beyond haploidentical transplant.

“Further investigations comparing the use of PTCy to ATG will help determine whether PTCy should be more broadly adopted as a standard-of-care GVHD prophylaxis approach, given currently available regimens,” he said in an interview.
 

Study details

The randomized phase 2b study (NCT02876679), conducted in centers in 11 cities in France, compared PTCy with ATG in patients with hematologic malignancies for whom a reduced-intensity allogeneic HSCT was indicated. This included patients aged 50 and older, and/or heavily pretreated patients who received an autologous HSCT or more than two prior lines of chemotherapy before allogeneic HSCT, as well as patients with poor performance status due to significant medical comorbidities.

Excluded from the trial were patients with creatinine clearance less than 30 mL/min; bilirubin or liver amino transferases more than three times the upper limit of normal; cardiac ejection fraction less than 40%; or pulmonary impairment with less than 50% lung carbon monoxide diffusing capacity.

Of 90 patients enrolled, 1 experienced a relapse before randomization, and the remaining 89 patients were assigned to either PTCy (experimental arm, 45 patients) or to ATG (control group, 44 patients).

Most patients had good performance status (Eastern Cooperative Oncology Group performance status 0 or 1). Diagnoses included acute myeloid and lymphoblastic leukemia, multiple myeloma, lymphomas, and myelodysplastic syndrome. The median age was 64 years, and the male to female ratio was about 2:1 in both groups.

All patients received “FB2” reduced-intensity conditioning with fludarabine30 mg/m2 per day for 4 days, and intravenous busulfan 130 mg/m2 per day for 2 days.

Patients in the experimental arm received cyclophosphamide 50 mg/kg per day on days 3 and 4 after transplant. Patients in the control group received ATG 2.5 mg/kg per day on days 3 and 2 prior to transplant.

All patients also received cyclosporine A, and those who had unrelated donors also received mycophenolate mofetil. In all, 39% of patients received cells from matched sibling donors, and 61% received cells from matched unrelated donors.
 

 

 

No significant differences seen

At 12 months of follow-up, there was no significant difference between the trial arms in the primary endpoint of GRFS, a composite of grade 3-4 acute GVHD, chronic GVHD requiring systemic treatment, relapse, or death. The rates of GRFS were 52.2% with PTCy vs. 45% with ATG.

Rates of disease-free survival were 68.5% with PTCy and 67.1% with ATG. The respective 12-month overall survival rates were 78.9% and 80.4%, respectively. The differences were not statistically significant.

The incidence of relapse at 1 year was 22.1% in the ATG group vs. 17.6% in the PTCy group. Respective nonrelapse mortality rates were 10.8% for the ATG group and 14% for the PTCy group. Neither difference was statistically significant.

There were also no significant between-group differences in the incidence at 12-month follow-up of either acute GVHD (34.9% PTCy arm vs. 24.3% ATG arm for grades II-IV combined, and 9.3% PTCy vs. 2.7% ATG for grades III or IV) or chronic GVHD (30.2% ATG vs. 26% PTCy).

The safety analysis showed no significant between-group differences in selected adverse events, including Epstein-Barr viral reactivation, cytomegalovirus reactivation, cardiac adverse events, or hemorrhagic cystitis.

The study was supported by Hospitals of Paris. Dr. Brissot and Dr. DeFilipp have disclosed no relevant financial relationships.

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

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A newer regimen was no more effective than an older regimen when both were compared for graft versus host disease (GVHD) prophylaxis in patients who underwent reduced-intensity conditioning followed by a hematopoietic stem cell transplant (HSCT) from a 10/10 HLA-matched related or unrelated donor.

These results come from a multicenter randomized trial that compared posttransplant cyclophosphamide (PTCy) to antithymocyte globulin (ATG), which has been used for decades.

There were no significant differences between the two in either disease-free or overall survival, GVHD-free relapse-free survival (GRFS), or nonrelapse mortality, reported lead investigator Eolia Brissot, MD, of Hôpital Saint-Antoine, Sorbonne University, Paris.

Her presentation was judged ‘top abstract’ at the annual meeting of the European Society for Blood and Marrow Transplantation (EBMT), held virtually because of the pandemic.

ATG has been used for more than 30 years for GVHD prophylaxis in allogeneic HSCT. In contrast, PTCy is the new kid on the block, developed to facilitate haploidentical transplants using unmanipulated bone marrow cells to act as a method for selective allodepletion in vivo.

“PTCy [has proved] to be effective in preventing both acute and chronic GVHD,” Dr. Brissot said. “However, controversial outcome data remain when comparing PTCy and ATG according to the type of donors.”

Until now, she noted, there have been no prospective randomized data  available for patients with donors (related or unrelated) that have 10 of 10 matched human leukocyte antigen (HLA) alleles. Hence, these were the patients studied in this latest trial, and in this population both regimens showed similar outcomes.

A bone marrow transplant specialist who was not involved in the study said that it’s a good first step.

“This is an important study to gain preliminary data to design a larger, subsequent phase 3 study,” said Zachariah DeFilipp, MD, of Mass General Cancer Center in Boston.

“The use of ATG as part of GVHD prophylaxis is common at many centers, especially in Europe, “ he explained. “The use of posttransplant cyclophosphamide is being expanded to more settings with transplant, beyond haploidentical transplant.

“Further investigations comparing the use of PTCy to ATG will help determine whether PTCy should be more broadly adopted as a standard-of-care GVHD prophylaxis approach, given currently available regimens,” he said in an interview.
 

Study details

The randomized phase 2b study (NCT02876679), conducted in centers in 11 cities in France, compared PTCy with ATG in patients with hematologic malignancies for whom a reduced-intensity allogeneic HSCT was indicated. This included patients aged 50 and older, and/or heavily pretreated patients who received an autologous HSCT or more than two prior lines of chemotherapy before allogeneic HSCT, as well as patients with poor performance status due to significant medical comorbidities.

Excluded from the trial were patients with creatinine clearance less than 30 mL/min; bilirubin or liver amino transferases more than three times the upper limit of normal; cardiac ejection fraction less than 40%; or pulmonary impairment with less than 50% lung carbon monoxide diffusing capacity.

Of 90 patients enrolled, 1 experienced a relapse before randomization, and the remaining 89 patients were assigned to either PTCy (experimental arm, 45 patients) or to ATG (control group, 44 patients).

Most patients had good performance status (Eastern Cooperative Oncology Group performance status 0 or 1). Diagnoses included acute myeloid and lymphoblastic leukemia, multiple myeloma, lymphomas, and myelodysplastic syndrome. The median age was 64 years, and the male to female ratio was about 2:1 in both groups.

All patients received “FB2” reduced-intensity conditioning with fludarabine30 mg/m2 per day for 4 days, and intravenous busulfan 130 mg/m2 per day for 2 days.

Patients in the experimental arm received cyclophosphamide 50 mg/kg per day on days 3 and 4 after transplant. Patients in the control group received ATG 2.5 mg/kg per day on days 3 and 2 prior to transplant.

All patients also received cyclosporine A, and those who had unrelated donors also received mycophenolate mofetil. In all, 39% of patients received cells from matched sibling donors, and 61% received cells from matched unrelated donors.
 

 

 

No significant differences seen

At 12 months of follow-up, there was no significant difference between the trial arms in the primary endpoint of GRFS, a composite of grade 3-4 acute GVHD, chronic GVHD requiring systemic treatment, relapse, or death. The rates of GRFS were 52.2% with PTCy vs. 45% with ATG.

Rates of disease-free survival were 68.5% with PTCy and 67.1% with ATG. The respective 12-month overall survival rates were 78.9% and 80.4%, respectively. The differences were not statistically significant.

The incidence of relapse at 1 year was 22.1% in the ATG group vs. 17.6% in the PTCy group. Respective nonrelapse mortality rates were 10.8% for the ATG group and 14% for the PTCy group. Neither difference was statistically significant.

There were also no significant between-group differences in the incidence at 12-month follow-up of either acute GVHD (34.9% PTCy arm vs. 24.3% ATG arm for grades II-IV combined, and 9.3% PTCy vs. 2.7% ATG for grades III or IV) or chronic GVHD (30.2% ATG vs. 26% PTCy).

The safety analysis showed no significant between-group differences in selected adverse events, including Epstein-Barr viral reactivation, cytomegalovirus reactivation, cardiac adverse events, or hemorrhagic cystitis.

The study was supported by Hospitals of Paris. Dr. Brissot and Dr. DeFilipp have disclosed no relevant financial relationships.

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

A newer regimen was no more effective than an older regimen when both were compared for graft versus host disease (GVHD) prophylaxis in patients who underwent reduced-intensity conditioning followed by a hematopoietic stem cell transplant (HSCT) from a 10/10 HLA-matched related or unrelated donor.

These results come from a multicenter randomized trial that compared posttransplant cyclophosphamide (PTCy) to antithymocyte globulin (ATG), which has been used for decades.

There were no significant differences between the two in either disease-free or overall survival, GVHD-free relapse-free survival (GRFS), or nonrelapse mortality, reported lead investigator Eolia Brissot, MD, of Hôpital Saint-Antoine, Sorbonne University, Paris.

Her presentation was judged ‘top abstract’ at the annual meeting of the European Society for Blood and Marrow Transplantation (EBMT), held virtually because of the pandemic.

ATG has been used for more than 30 years for GVHD prophylaxis in allogeneic HSCT. In contrast, PTCy is the new kid on the block, developed to facilitate haploidentical transplants using unmanipulated bone marrow cells to act as a method for selective allodepletion in vivo.

“PTCy [has proved] to be effective in preventing both acute and chronic GVHD,” Dr. Brissot said. “However, controversial outcome data remain when comparing PTCy and ATG according to the type of donors.”

Until now, she noted, there have been no prospective randomized data  available for patients with donors (related or unrelated) that have 10 of 10 matched human leukocyte antigen (HLA) alleles. Hence, these were the patients studied in this latest trial, and in this population both regimens showed similar outcomes.

A bone marrow transplant specialist who was not involved in the study said that it’s a good first step.

“This is an important study to gain preliminary data to design a larger, subsequent phase 3 study,” said Zachariah DeFilipp, MD, of Mass General Cancer Center in Boston.

“The use of ATG as part of GVHD prophylaxis is common at many centers, especially in Europe, “ he explained. “The use of posttransplant cyclophosphamide is being expanded to more settings with transplant, beyond haploidentical transplant.

“Further investigations comparing the use of PTCy to ATG will help determine whether PTCy should be more broadly adopted as a standard-of-care GVHD prophylaxis approach, given currently available regimens,” he said in an interview.
 

Study details

The randomized phase 2b study (NCT02876679), conducted in centers in 11 cities in France, compared PTCy with ATG in patients with hematologic malignancies for whom a reduced-intensity allogeneic HSCT was indicated. This included patients aged 50 and older, and/or heavily pretreated patients who received an autologous HSCT or more than two prior lines of chemotherapy before allogeneic HSCT, as well as patients with poor performance status due to significant medical comorbidities.

Excluded from the trial were patients with creatinine clearance less than 30 mL/min; bilirubin or liver amino transferases more than three times the upper limit of normal; cardiac ejection fraction less than 40%; or pulmonary impairment with less than 50% lung carbon monoxide diffusing capacity.

Of 90 patients enrolled, 1 experienced a relapse before randomization, and the remaining 89 patients were assigned to either PTCy (experimental arm, 45 patients) or to ATG (control group, 44 patients).

Most patients had good performance status (Eastern Cooperative Oncology Group performance status 0 or 1). Diagnoses included acute myeloid and lymphoblastic leukemia, multiple myeloma, lymphomas, and myelodysplastic syndrome. The median age was 64 years, and the male to female ratio was about 2:1 in both groups.

All patients received “FB2” reduced-intensity conditioning with fludarabine30 mg/m2 per day for 4 days, and intravenous busulfan 130 mg/m2 per day for 2 days.

Patients in the experimental arm received cyclophosphamide 50 mg/kg per day on days 3 and 4 after transplant. Patients in the control group received ATG 2.5 mg/kg per day on days 3 and 2 prior to transplant.

All patients also received cyclosporine A, and those who had unrelated donors also received mycophenolate mofetil. In all, 39% of patients received cells from matched sibling donors, and 61% received cells from matched unrelated donors.
 

 

 

No significant differences seen

At 12 months of follow-up, there was no significant difference between the trial arms in the primary endpoint of GRFS, a composite of grade 3-4 acute GVHD, chronic GVHD requiring systemic treatment, relapse, or death. The rates of GRFS were 52.2% with PTCy vs. 45% with ATG.

Rates of disease-free survival were 68.5% with PTCy and 67.1% with ATG. The respective 12-month overall survival rates were 78.9% and 80.4%, respectively. The differences were not statistically significant.

The incidence of relapse at 1 year was 22.1% in the ATG group vs. 17.6% in the PTCy group. Respective nonrelapse mortality rates were 10.8% for the ATG group and 14% for the PTCy group. Neither difference was statistically significant.

There were also no significant between-group differences in the incidence at 12-month follow-up of either acute GVHD (34.9% PTCy arm vs. 24.3% ATG arm for grades II-IV combined, and 9.3% PTCy vs. 2.7% ATG for grades III or IV) or chronic GVHD (30.2% ATG vs. 26% PTCy).

The safety analysis showed no significant between-group differences in selected adverse events, including Epstein-Barr viral reactivation, cytomegalovirus reactivation, cardiac adverse events, or hemorrhagic cystitis.

The study was supported by Hospitals of Paris. Dr. Brissot and Dr. DeFilipp have disclosed no relevant financial relationships.

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

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Highlights in Atopic Dermatitis From AAAAI 2021

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Highlights in Atopic Dermatitis From AAAAI 2021

Dr Elaine Siegfried, an expert in pediatric dermatology in St. Louis, Missouri, examines some of the key data and research highlights in atopic dermatitis presented at the 2021 American Academy of Allergy, Asthma & Immunology (AAAAI) Virtual Annual Meeting.

 

Dr Siegfried starts with two studies on the selective JAK1 inhibitor abrocitinib, in which results in both adults and adolescents confirm the efficacy of the 200 mg dose. However, she cautions that the jury is still out on the long-term safety for this class of drugs.

 

She then reviews two studies looking at whether individuals with atopic dermatitis who are hospitalized with COVID-19 suffer more severe outcomes than the general population.

 

Dr Siegfried's final selections focus on food allergy, an important aspect of management in patients with atopic dermatitis.

 

The first two look at the outcomes of food challenges in shrimp-sensitized children and those with a history suggestive of milk allergy.

 

The last three studies examine the latest data on an oral immunotherapy peanut allergen powder (Palforzia) approved by the FDA and some of the nonclinical factors that could hamper its uptake.

--

Director, Division of Pediatric Dermatology, Cardinal Glennon Children's Hospital, Saint Louis University Health Sciences Center; Owner, Director, Kids Dermatology, St. Louis, Missouri

Elaine C. Siegfried, MD, has disclosed the following relevant financial relationships:

Contracted research from: AI Therapeutics.

Received consulting fees from: Boehringer Ingelheim; Incyte; Regeneron; Sanofi Genzyme; UCB; AbbVie; Verrica; Leo; Novan; Novartis; Pfizer; Pierre Fabre

Received honoraria from: Regeneron; Sanofi Genzyme; Verrica.

Received fees to SSM/SLU related to sponsoring clinical trials from: Regeneron; Verrica; Pierre Fabre; Janssen; Eli Lilly and Company.

Served on the Data Safety Monitoring Board for: UCB; Leo; Pfizer; Novan.

Received grant funding to support 2020-2022 Peds Derm Fellow from: Pfizer.

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Dr Elaine Siegfried, an expert in pediatric dermatology in St. Louis, Missouri, examines some of the key data and research highlights in atopic dermatitis presented at the 2021 American Academy of Allergy, Asthma & Immunology (AAAAI) Virtual Annual Meeting.

 

Dr Siegfried starts with two studies on the selective JAK1 inhibitor abrocitinib, in which results in both adults and adolescents confirm the efficacy of the 200 mg dose. However, she cautions that the jury is still out on the long-term safety for this class of drugs.

 

She then reviews two studies looking at whether individuals with atopic dermatitis who are hospitalized with COVID-19 suffer more severe outcomes than the general population.

 

Dr Siegfried's final selections focus on food allergy, an important aspect of management in patients with atopic dermatitis.

 

The first two look at the outcomes of food challenges in shrimp-sensitized children and those with a history suggestive of milk allergy.

 

The last three studies examine the latest data on an oral immunotherapy peanut allergen powder (Palforzia) approved by the FDA and some of the nonclinical factors that could hamper its uptake.

--

Director, Division of Pediatric Dermatology, Cardinal Glennon Children's Hospital, Saint Louis University Health Sciences Center; Owner, Director, Kids Dermatology, St. Louis, Missouri

Elaine C. Siegfried, MD, has disclosed the following relevant financial relationships:

Contracted research from: AI Therapeutics.

Received consulting fees from: Boehringer Ingelheim; Incyte; Regeneron; Sanofi Genzyme; UCB; AbbVie; Verrica; Leo; Novan; Novartis; Pfizer; Pierre Fabre

Received honoraria from: Regeneron; Sanofi Genzyme; Verrica.

Received fees to SSM/SLU related to sponsoring clinical trials from: Regeneron; Verrica; Pierre Fabre; Janssen; Eli Lilly and Company.

Served on the Data Safety Monitoring Board for: UCB; Leo; Pfizer; Novan.

Received grant funding to support 2020-2022 Peds Derm Fellow from: Pfizer.

Dr Elaine Siegfried, an expert in pediatric dermatology in St. Louis, Missouri, examines some of the key data and research highlights in atopic dermatitis presented at the 2021 American Academy of Allergy, Asthma & Immunology (AAAAI) Virtual Annual Meeting.

 

Dr Siegfried starts with two studies on the selective JAK1 inhibitor abrocitinib, in which results in both adults and adolescents confirm the efficacy of the 200 mg dose. However, she cautions that the jury is still out on the long-term safety for this class of drugs.

 

She then reviews two studies looking at whether individuals with atopic dermatitis who are hospitalized with COVID-19 suffer more severe outcomes than the general population.

 

Dr Siegfried's final selections focus on food allergy, an important aspect of management in patients with atopic dermatitis.

 

The first two look at the outcomes of food challenges in shrimp-sensitized children and those with a history suggestive of milk allergy.

 

The last three studies examine the latest data on an oral immunotherapy peanut allergen powder (Palforzia) approved by the FDA and some of the nonclinical factors that could hamper its uptake.

--

Director, Division of Pediatric Dermatology, Cardinal Glennon Children's Hospital, Saint Louis University Health Sciences Center; Owner, Director, Kids Dermatology, St. Louis, Missouri

Elaine C. Siegfried, MD, has disclosed the following relevant financial relationships:

Contracted research from: AI Therapeutics.

Received consulting fees from: Boehringer Ingelheim; Incyte; Regeneron; Sanofi Genzyme; UCB; AbbVie; Verrica; Leo; Novan; Novartis; Pfizer; Pierre Fabre

Received honoraria from: Regeneron; Sanofi Genzyme; Verrica.

Received fees to SSM/SLU related to sponsoring clinical trials from: Regeneron; Verrica; Pierre Fabre; Janssen; Eli Lilly and Company.

Served on the Data Safety Monitoring Board for: UCB; Leo; Pfizer; Novan.

Received grant funding to support 2020-2022 Peds Derm Fellow from: Pfizer.

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Highlights in Atopic Dermatitis From AAAAI 2021
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Cardiac rehab after cardiac valve surgery associated with reduced mortality

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Background: National guidelines recommend CR after CVS. However, neither enrollment in CR nor its benefits have been well described in this population.



Study design: Observational cohort study.

Setting: Enrolled Medicare beneficiaries residing in the United States in 2014.

Synopsis: There were 41,369 Medicare patients who underwent CVS and met the study requirements; of these, 43.2% enrolled in CR programs. Those who had concomitant coronary artery bypass grafting (CABG) surgery or who resided in the Midwest region of the United States were more likely to enroll in CR. Asian, black, and Hispanic patients were less likely to enroll in CR. Enrollment in CR after CVS was associated with a decreased risk of 1-year hospitalization (hazard ratio, 0.66; 95% confidence interval, 0.63-0.69). CR utilization was also associated with a decrease in 1-year mortality after CVS (HR, 0.39; 95% CI, 0.35-0.44).

Enrollment rates in CR after CVS were lower than that of heart transplant patients, but higher than that for patients with systolic heart failure or after CABG. Major study limitations were the lack of generalizability to younger patients because all patients examined were older than 64 years.

Bottom line: Racial and geographic factors influence the rate of enrollment in CR for patients undergoing CVS. All patients should be encouraged to participate in CR after CVS because it is associated with reduced 1-year mortality and risk of hospitalization.

Citation: Patel DK et. al. Association of cardiac rehabilitation with decreased hospitalization and mortality risk after cardiac valve surgery. JAMA Cardiol. 2019 Oct 23. doi: 10.1001/jamacardio.2019.4032.
 

Dr. Babbel is a hospitalist and assistant professor of medicine at the University of Utah, Salt Lake City.

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Background: National guidelines recommend CR after CVS. However, neither enrollment in CR nor its benefits have been well described in this population.



Study design: Observational cohort study.

Setting: Enrolled Medicare beneficiaries residing in the United States in 2014.

Synopsis: There were 41,369 Medicare patients who underwent CVS and met the study requirements; of these, 43.2% enrolled in CR programs. Those who had concomitant coronary artery bypass grafting (CABG) surgery or who resided in the Midwest region of the United States were more likely to enroll in CR. Asian, black, and Hispanic patients were less likely to enroll in CR. Enrollment in CR after CVS was associated with a decreased risk of 1-year hospitalization (hazard ratio, 0.66; 95% confidence interval, 0.63-0.69). CR utilization was also associated with a decrease in 1-year mortality after CVS (HR, 0.39; 95% CI, 0.35-0.44).

Enrollment rates in CR after CVS were lower than that of heart transplant patients, but higher than that for patients with systolic heart failure or after CABG. Major study limitations were the lack of generalizability to younger patients because all patients examined were older than 64 years.

Bottom line: Racial and geographic factors influence the rate of enrollment in CR for patients undergoing CVS. All patients should be encouraged to participate in CR after CVS because it is associated with reduced 1-year mortality and risk of hospitalization.

Citation: Patel DK et. al. Association of cardiac rehabilitation with decreased hospitalization and mortality risk after cardiac valve surgery. JAMA Cardiol. 2019 Oct 23. doi: 10.1001/jamacardio.2019.4032.
 

Dr. Babbel is a hospitalist and assistant professor of medicine at the University of Utah, Salt Lake City.

Background: National guidelines recommend CR after CVS. However, neither enrollment in CR nor its benefits have been well described in this population.



Study design: Observational cohort study.

Setting: Enrolled Medicare beneficiaries residing in the United States in 2014.

Synopsis: There were 41,369 Medicare patients who underwent CVS and met the study requirements; of these, 43.2% enrolled in CR programs. Those who had concomitant coronary artery bypass grafting (CABG) surgery or who resided in the Midwest region of the United States were more likely to enroll in CR. Asian, black, and Hispanic patients were less likely to enroll in CR. Enrollment in CR after CVS was associated with a decreased risk of 1-year hospitalization (hazard ratio, 0.66; 95% confidence interval, 0.63-0.69). CR utilization was also associated with a decrease in 1-year mortality after CVS (HR, 0.39; 95% CI, 0.35-0.44).

Enrollment rates in CR after CVS were lower than that of heart transplant patients, but higher than that for patients with systolic heart failure or after CABG. Major study limitations were the lack of generalizability to younger patients because all patients examined were older than 64 years.

Bottom line: Racial and geographic factors influence the rate of enrollment in CR for patients undergoing CVS. All patients should be encouraged to participate in CR after CVS because it is associated with reduced 1-year mortality and risk of hospitalization.

Citation: Patel DK et. al. Association of cardiac rehabilitation with decreased hospitalization and mortality risk after cardiac valve surgery. JAMA Cardiol. 2019 Oct 23. doi: 10.1001/jamacardio.2019.4032.
 

Dr. Babbel is a hospitalist and assistant professor of medicine at the University of Utah, Salt Lake City.

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Adherence to antireflux lifestyle factors shows benefit in women

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Fri, 03/19/2021 - 16:47

 

Antireflux lifestyle factors may significantly reduce the risk of gastroesophageal reflux disease (GERD), according to an analysis involving almost 43,000 women.

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Even alongside therapy with a proton-pump inhibitor (PPI) and/or a histamine-receptor antagonist (H2RA), adherence to five antireflux lifestyle factors had a meaningful impact on risk for GERD symptoms, possibly preventing nearly 40% of cases with weekly GERD symptoms, reported lead author Raaj S. Mehta, MD, of Massachusetts General Hospital and Harvard Medical School, both in Boston, and colleagues.

“Clinicians recommend dietary and lifestyle modifications to prevent GERD symptoms, but no prospective data are available to inform these recommendations,” Dr. Mehta and colleagues wrote in JAMA Internal Medicine.

To address this gap, the investigators turned to the Nurses’ Health Study II, a nationwide, prospective study involving 116,671 women. The study, which has a follow-up rate exceeding 90%, began in 1989 and is ongoing. Participants complete biennial questionnaires that include a variety of health and lifestyle factors. In 2005, 2009, 2013, and 2017, the questionnaire inquired about heartburn or acid reflux.

The present analysis included data from 42,955 women aged 42-62 years. Participants were excluded at baseline if they had cancer, lacked dietary data, were lost to follow-up, already had GERD symptoms at least weekly, or used a PPI and/or H2RA on a regular basis. The final dataset included 392,215 person-years of follow-up, with 9,291 incident cases of GERD symptoms.

For each participant, the presence of five possible antireflux lifestyle factors were added together for a score ranging from 0 to 5: no more than two cups of soda, tea, or coffee per day; never smoking; normal body weight (BMI ≥18.5 and <25.0 kg/m2); “prudent” diet, based on top 40% of dietary pattern score; and at least 30 minutes of moderate to vigorous physical activity each day.

Multivariate logistic regression modeling showed that women who reported all five antireflux lifestyle factors had a 50% decreased risk of GERD symptoms (hazard ratio, 0.50; 95% confidence interval, 0.42-0.59), compared with women who adhered to none of them. Further analysis suggested that the collective effect of all five factors could reduce GERD symptom case volume by 37% (95% CI, 28%-46%).

Dr. Mehta

Nonadherence to each antireflux lifestyle factor was independently associated with an increased risk of GERD symptoms. After mutual adjustment for other variables, BMI was associated with the highest population-attributable risk (19%), followed by physical activity (8%), food intake (7%), beverage intake (4%), and nonsmoker status (3%).

Dr. Mehta and colleagues also explored the relationship between GERD symptoms, antireflux medications, and lifestyle factors. Presence of all five antireflux factors was associated with a 53% decreased risk of GERD symptoms or initiation of PPI and/or H2RA therapy (HR, 0.47; 95% CI, 0.41-0.54). Among a group of 3,625 women who reported regular use of a PPI and/or H2RA and were free of GERD symptoms at baseline, adherence to all five lifestyle factors reduced risk of GERD symptoms by 68% (HR, 0.32; 95% CI, 0.18-0.57).

One limitation of the study was that its population was primarily White women; however, the authors noted a study suggesting GERD is more common in White women aged 30-60 years.

“Adherence to an antireflux lifestyle, even among regular users of PPIs and/or H2RAs, was associated with a decreased risk of GERD symptoms,” the investigators concluded.

 

 

Lifestyle matters

According to Ronnie Fass, MD, medical director of the Digestive Health Center at Case Western Reserve University, Cleveland, “This is the first study to show the incremental effect and thus the benefit of lifestyle factors in reducing the risk of GERD symptoms. While only five lifestyle factors were assessed in this study, potentially others may further decrease the risk for symptoms.”

Dr. Fass

Dr. Fass suggested that the nature of the data, which was self-reported, and the entirely female patient population, should inform interpretation of the findings.

“While nonerosive reflux disease is relatively more common in women, erosive esophagitis and Barrett’s esophagus are more common in men,” he said. “Furthermore, male gender is associated with more severe GERD and GERD complications.”

Yet Dr. Fass concluded by again emphasizing the merit of the analysis: “This is an important study that further supports the value of certain lifestyle factors in reducing the risk of GERD symptoms,” he said. “What is challenging for practicing physicians is to get patients to follow these lifestyle factors long term.”

The study was funded by the National Institutes of Health and by a Stuart and Suzanne Steele Massachusetts General Hospital Research Scholar Award. The investigators and Dr. Fass disclosed no conflicts of interest.

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Antireflux lifestyle factors may significantly reduce the risk of gastroesophageal reflux disease (GERD), according to an analysis involving almost 43,000 women.

Tharakorn/Getty Images

Even alongside therapy with a proton-pump inhibitor (PPI) and/or a histamine-receptor antagonist (H2RA), adherence to five antireflux lifestyle factors had a meaningful impact on risk for GERD symptoms, possibly preventing nearly 40% of cases with weekly GERD symptoms, reported lead author Raaj S. Mehta, MD, of Massachusetts General Hospital and Harvard Medical School, both in Boston, and colleagues.

“Clinicians recommend dietary and lifestyle modifications to prevent GERD symptoms, but no prospective data are available to inform these recommendations,” Dr. Mehta and colleagues wrote in JAMA Internal Medicine.

To address this gap, the investigators turned to the Nurses’ Health Study II, a nationwide, prospective study involving 116,671 women. The study, which has a follow-up rate exceeding 90%, began in 1989 and is ongoing. Participants complete biennial questionnaires that include a variety of health and lifestyle factors. In 2005, 2009, 2013, and 2017, the questionnaire inquired about heartburn or acid reflux.

The present analysis included data from 42,955 women aged 42-62 years. Participants were excluded at baseline if they had cancer, lacked dietary data, were lost to follow-up, already had GERD symptoms at least weekly, or used a PPI and/or H2RA on a regular basis. The final dataset included 392,215 person-years of follow-up, with 9,291 incident cases of GERD symptoms.

For each participant, the presence of five possible antireflux lifestyle factors were added together for a score ranging from 0 to 5: no more than two cups of soda, tea, or coffee per day; never smoking; normal body weight (BMI ≥18.5 and <25.0 kg/m2); “prudent” diet, based on top 40% of dietary pattern score; and at least 30 minutes of moderate to vigorous physical activity each day.

Multivariate logistic regression modeling showed that women who reported all five antireflux lifestyle factors had a 50% decreased risk of GERD symptoms (hazard ratio, 0.50; 95% confidence interval, 0.42-0.59), compared with women who adhered to none of them. Further analysis suggested that the collective effect of all five factors could reduce GERD symptom case volume by 37% (95% CI, 28%-46%).

Dr. Mehta

Nonadherence to each antireflux lifestyle factor was independently associated with an increased risk of GERD symptoms. After mutual adjustment for other variables, BMI was associated with the highest population-attributable risk (19%), followed by physical activity (8%), food intake (7%), beverage intake (4%), and nonsmoker status (3%).

Dr. Mehta and colleagues also explored the relationship between GERD symptoms, antireflux medications, and lifestyle factors. Presence of all five antireflux factors was associated with a 53% decreased risk of GERD symptoms or initiation of PPI and/or H2RA therapy (HR, 0.47; 95% CI, 0.41-0.54). Among a group of 3,625 women who reported regular use of a PPI and/or H2RA and were free of GERD symptoms at baseline, adherence to all five lifestyle factors reduced risk of GERD symptoms by 68% (HR, 0.32; 95% CI, 0.18-0.57).

One limitation of the study was that its population was primarily White women; however, the authors noted a study suggesting GERD is more common in White women aged 30-60 years.

“Adherence to an antireflux lifestyle, even among regular users of PPIs and/or H2RAs, was associated with a decreased risk of GERD symptoms,” the investigators concluded.

 

 

Lifestyle matters

According to Ronnie Fass, MD, medical director of the Digestive Health Center at Case Western Reserve University, Cleveland, “This is the first study to show the incremental effect and thus the benefit of lifestyle factors in reducing the risk of GERD symptoms. While only five lifestyle factors were assessed in this study, potentially others may further decrease the risk for symptoms.”

Dr. Fass

Dr. Fass suggested that the nature of the data, which was self-reported, and the entirely female patient population, should inform interpretation of the findings.

“While nonerosive reflux disease is relatively more common in women, erosive esophagitis and Barrett’s esophagus are more common in men,” he said. “Furthermore, male gender is associated with more severe GERD and GERD complications.”

Yet Dr. Fass concluded by again emphasizing the merit of the analysis: “This is an important study that further supports the value of certain lifestyle factors in reducing the risk of GERD symptoms,” he said. “What is challenging for practicing physicians is to get patients to follow these lifestyle factors long term.”

The study was funded by the National Institutes of Health and by a Stuart and Suzanne Steele Massachusetts General Hospital Research Scholar Award. The investigators and Dr. Fass disclosed no conflicts of interest.

 

Antireflux lifestyle factors may significantly reduce the risk of gastroesophageal reflux disease (GERD), according to an analysis involving almost 43,000 women.

Tharakorn/Getty Images

Even alongside therapy with a proton-pump inhibitor (PPI) and/or a histamine-receptor antagonist (H2RA), adherence to five antireflux lifestyle factors had a meaningful impact on risk for GERD symptoms, possibly preventing nearly 40% of cases with weekly GERD symptoms, reported lead author Raaj S. Mehta, MD, of Massachusetts General Hospital and Harvard Medical School, both in Boston, and colleagues.

“Clinicians recommend dietary and lifestyle modifications to prevent GERD symptoms, but no prospective data are available to inform these recommendations,” Dr. Mehta and colleagues wrote in JAMA Internal Medicine.

To address this gap, the investigators turned to the Nurses’ Health Study II, a nationwide, prospective study involving 116,671 women. The study, which has a follow-up rate exceeding 90%, began in 1989 and is ongoing. Participants complete biennial questionnaires that include a variety of health and lifestyle factors. In 2005, 2009, 2013, and 2017, the questionnaire inquired about heartburn or acid reflux.

The present analysis included data from 42,955 women aged 42-62 years. Participants were excluded at baseline if they had cancer, lacked dietary data, were lost to follow-up, already had GERD symptoms at least weekly, or used a PPI and/or H2RA on a regular basis. The final dataset included 392,215 person-years of follow-up, with 9,291 incident cases of GERD symptoms.

For each participant, the presence of five possible antireflux lifestyle factors were added together for a score ranging from 0 to 5: no more than two cups of soda, tea, or coffee per day; never smoking; normal body weight (BMI ≥18.5 and <25.0 kg/m2); “prudent” diet, based on top 40% of dietary pattern score; and at least 30 minutes of moderate to vigorous physical activity each day.

Multivariate logistic regression modeling showed that women who reported all five antireflux lifestyle factors had a 50% decreased risk of GERD symptoms (hazard ratio, 0.50; 95% confidence interval, 0.42-0.59), compared with women who adhered to none of them. Further analysis suggested that the collective effect of all five factors could reduce GERD symptom case volume by 37% (95% CI, 28%-46%).

Dr. Mehta

Nonadherence to each antireflux lifestyle factor was independently associated with an increased risk of GERD symptoms. After mutual adjustment for other variables, BMI was associated with the highest population-attributable risk (19%), followed by physical activity (8%), food intake (7%), beverage intake (4%), and nonsmoker status (3%).

Dr. Mehta and colleagues also explored the relationship between GERD symptoms, antireflux medications, and lifestyle factors. Presence of all five antireflux factors was associated with a 53% decreased risk of GERD symptoms or initiation of PPI and/or H2RA therapy (HR, 0.47; 95% CI, 0.41-0.54). Among a group of 3,625 women who reported regular use of a PPI and/or H2RA and were free of GERD symptoms at baseline, adherence to all five lifestyle factors reduced risk of GERD symptoms by 68% (HR, 0.32; 95% CI, 0.18-0.57).

One limitation of the study was that its population was primarily White women; however, the authors noted a study suggesting GERD is more common in White women aged 30-60 years.

“Adherence to an antireflux lifestyle, even among regular users of PPIs and/or H2RAs, was associated with a decreased risk of GERD symptoms,” the investigators concluded.

 

 

Lifestyle matters

According to Ronnie Fass, MD, medical director of the Digestive Health Center at Case Western Reserve University, Cleveland, “This is the first study to show the incremental effect and thus the benefit of lifestyle factors in reducing the risk of GERD symptoms. While only five lifestyle factors were assessed in this study, potentially others may further decrease the risk for symptoms.”

Dr. Fass

Dr. Fass suggested that the nature of the data, which was self-reported, and the entirely female patient population, should inform interpretation of the findings.

“While nonerosive reflux disease is relatively more common in women, erosive esophagitis and Barrett’s esophagus are more common in men,” he said. “Furthermore, male gender is associated with more severe GERD and GERD complications.”

Yet Dr. Fass concluded by again emphasizing the merit of the analysis: “This is an important study that further supports the value of certain lifestyle factors in reducing the risk of GERD symptoms,” he said. “What is challenging for practicing physicians is to get patients to follow these lifestyle factors long term.”

The study was funded by the National Institutes of Health and by a Stuart and Suzanne Steele Massachusetts General Hospital Research Scholar Award. The investigators and Dr. Fass disclosed no conflicts of interest.

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High obesity rates in Southern states magnify COVID threats

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In January, as Mississippi health officials planned for their incoming shipments of COVID-19 vaccine, they assessed the state’s most vulnerable: health care workers, of course, and elderly people in nursing homes. But among those who needed urgent protection from the virus ripping across the Magnolia State were 1 million Mississippians with obesity.

Obesity and weight-related illnesses have been deadly liabilities in the COVID era. A report released this month by the World Obesity Federation found that increased body weight is the second-greatest predictor of COVID-related hospitalization and death across the globe, trailing only old age as a risk factor.

As a fixture of life in the American South – home to 9 of the nation’s 12 heaviest states – obesity is playing a role not only in COVID outcomes, but in the calculus of the vaccination rollout. Mississippi was one of the first states to add a body mass index of 30 or more (a rough gauge of obesity tied to height and weight) to the list of qualifying medical conditions for a shot. About 40% of the state’s adults meet that definition, according to federal health survey data, and combined with the risk group already eligible for vaccination – residents 65 and older – that means fully half of Mississippi’s adults are entitled to vie for a restricted allotment of shots.

At least 29 states have green-lighted obesity for inclusion in the first phases of the vaccine rollout, according to KFF – a vast widening of eligibility that has the potential to overwhelm government efforts and heighten competition for scarce doses.

“We have a lifesaving intervention, and we don’t have enough of it,” said Jen Kates, PhD, director of global health and HIV policy for Kaiser Family Foundation. “Hard choices are being made about who should go first, and there is no right answer.”

The sheer prevalence of obesity in the nation – two in three Americans exceed what is considered a healthy weight – was a public health concern well before the pandemic. But COVID-19 dramatically fast-tracked the discussion from warnings about the long-term damage excess fat tissue can pose to heart, lung and metabolic functions to far more immediate threats.

In the United Kingdom, for example, overweight COVID patients were 67% more likely to require intensive care, and obese patients three times likelier, according to the World Obesity Federation report. A Centers for Disease Control and Prevention study released Monday found a similar trend among U.S. patients and noted that the risk of COVID-related hospitalization, ventilation and death increased with patients’ obesity level.

The counties that hug the southern Mississippi River are home to some of the most concentrated pockets of extreme obesity in the United States. Coronavirus infections began surging in Southern states early last summer, and hospitalizations rose in step.

Deaths in rural stretches of Arkansas, Louisiana, Mississippi, and Tennessee have been overshadowed by the sheer number of deaths in metropolitan areas like New York, Los Angeles, and Essex County, N.J. But as a share of the population, the coronavirus has been similarly unsparing in many Southern communities. In sparsely populated Claiborne County, Miss., on the floodplains of the Mississippi River, 30 residents – about 1 in 300 – had died as of early March. In East Feliciana Parish, La., north of Baton Rouge, with 106 deaths, about 1 in 180 had died by then.

“It’s just math. If the population is more obese and obesity clearly contributes to worse outcomes, then neighborhoods, cities, states and countries that are more obese will have a greater toll from COVID,” said Dr. James de Lemos, MD, a professor of internal medicine at UT Southwestern Medical Center in Dallas who led a study of hospitalized COVID patients published in the medical journal Circulation.

And, because in the U.S. obesity rates tend to be relatively high among African Americans and Latinos who are poor, with diminished access to health care, “it’s a triple whammy,” Dr. de Lemos said. “All these things intersect.”

Poverty and limited access to medical care are common features in the South, where residents like Michelle Antonyshyn, a former registered nurse and mother of seven in Salem, Ark., say they are afraid of the virus. Ms. Antonyshyn, 49, has obesity and debilitating pain in her knees and back, though she does not have high blood pressure or diabetes, two underlying conditions that federal health officials have determined are added risk factors for severe cases of COVID-19.

Still, she said, she “was very concerned just knowing that being obese puts you more at risk for bad outcomes such as being on a ventilator and death.” As a precaution, Ms. Antonyshyn said, she and her large brood locked down early and stopped attending church services in person, watching online instead.

“It’s not the same as having fellowship, but the risk for me was enough,” said Ms. Antonyshyn.

Governors throughout the South seem to recognize that weight can contribute to COVID-19 complications and have pushed for vaccine eligibility rules that prioritize obesity. But on the ground, local health officials are girding for having to tell newly eligible people who qualify as obese that there aren’t enough shots to go around.

In Port Gibson, Miss., Mheja Williams, MD, medical director of the Claiborne County Family Health Center, has been receiving barely enough doses to inoculate the health workers and oldest seniors in her county of 9,600. One week in early February, she received 100 doses.

Obesity and extreme obesity are endemic in Claiborne County, and health officials say the “normalization” of obesity means people often don’t register their weight as a risk factor, whether for COVID or other health issues. The risks are exacerbated by a general flouting of pandemic etiquette: Dr. Williams said that middle-aged and younger residents are not especially vigilant about physical distancing and that mask use is rare.

The rise of obesity in the United States is well documented over the past half-century, as the nation turned from a diet of fruits, vegetables and limited meats to one laden with ultra-processed foods and rich with salt, fat, sugar, and flavorings, along with copious amounts of meat, fast food, and soda. The U.S. has generally led the global obesity race, setting records as even toddlers and young children grew implausibly, dangerously overweight.

Well before COVID, obesity was a leading cause of preventable death in the United States. The National Institutes of Health declared it a disease in 1998, one that fosters heart disease, stroke, type 2 diabetes, and breast, colon, and other cancers.

Researchers say it is no coincidence that nations like the United States, the United Kingdom, and Italy, with relatively high obesity rates, have proved particularly vulnerable to the novel coronavirus.

They believe the virus may exploit underlying metabolic and physiological impairments that often exist in concert with obesity. Extra fat can lead to a cascade of metabolic disruptions, chronic systemic inflammation, and hormonal dysregulation that may thwart the body’s response to infection.

Other respiratory viruses, like influenza and SARS, which appeared in China in 2002, rely on cholesterol to spread enveloped RNA virus to neighboring cells, and researchers have proposed that a similar mechanism may play a role in the spread of the novel coronavirus.

There are also practical problems for coronavirus patients with obesity admitted to the hospital. They can be more difficult to intubate because of excess central weight pressing down on the diaphragm, making breathing with infected lungs even more difficult.

Physicians who specialize in treating patients with obesity say public health officials need to be more forthright and urgent in their messaging, telegraphing the risks of this COVID era.

“It should be explicit and direct,” said Fatima Stanford, MD, an obesity medicine specialist at Massachusetts General Hospital, Boston, and a Harvard Medical School instructor.

Dr. Stanford denounces the fat-shaming and bullying that people with obesity often experience. But telling patients – and the public – that obesity increases the risk of hospitalization and death is crucial, she said.

“I don’t think it’s stigmatizing,” she said. “If you tell them in that way, it’s not to scare you, it’s just giving information. Sometimes people are just unaware.”



KHN (Kaiser Health News) is a national newsroom that produces in-depth journalism about health issues. Together with Policy Analysis and Polling, KHN is one of the three major operating programs at KFF (Kaiser Family Foundation). KFF is an endowed nonprofit organization providing information on health issues to the nation.

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In January, as Mississippi health officials planned for their incoming shipments of COVID-19 vaccine, they assessed the state’s most vulnerable: health care workers, of course, and elderly people in nursing homes. But among those who needed urgent protection from the virus ripping across the Magnolia State were 1 million Mississippians with obesity.

Obesity and weight-related illnesses have been deadly liabilities in the COVID era. A report released this month by the World Obesity Federation found that increased body weight is the second-greatest predictor of COVID-related hospitalization and death across the globe, trailing only old age as a risk factor.

As a fixture of life in the American South – home to 9 of the nation’s 12 heaviest states – obesity is playing a role not only in COVID outcomes, but in the calculus of the vaccination rollout. Mississippi was one of the first states to add a body mass index of 30 or more (a rough gauge of obesity tied to height and weight) to the list of qualifying medical conditions for a shot. About 40% of the state’s adults meet that definition, according to federal health survey data, and combined with the risk group already eligible for vaccination – residents 65 and older – that means fully half of Mississippi’s adults are entitled to vie for a restricted allotment of shots.

At least 29 states have green-lighted obesity for inclusion in the first phases of the vaccine rollout, according to KFF – a vast widening of eligibility that has the potential to overwhelm government efforts and heighten competition for scarce doses.

“We have a lifesaving intervention, and we don’t have enough of it,” said Jen Kates, PhD, director of global health and HIV policy for Kaiser Family Foundation. “Hard choices are being made about who should go first, and there is no right answer.”

The sheer prevalence of obesity in the nation – two in three Americans exceed what is considered a healthy weight – was a public health concern well before the pandemic. But COVID-19 dramatically fast-tracked the discussion from warnings about the long-term damage excess fat tissue can pose to heart, lung and metabolic functions to far more immediate threats.

In the United Kingdom, for example, overweight COVID patients were 67% more likely to require intensive care, and obese patients three times likelier, according to the World Obesity Federation report. A Centers for Disease Control and Prevention study released Monday found a similar trend among U.S. patients and noted that the risk of COVID-related hospitalization, ventilation and death increased with patients’ obesity level.

The counties that hug the southern Mississippi River are home to some of the most concentrated pockets of extreme obesity in the United States. Coronavirus infections began surging in Southern states early last summer, and hospitalizations rose in step.

Deaths in rural stretches of Arkansas, Louisiana, Mississippi, and Tennessee have been overshadowed by the sheer number of deaths in metropolitan areas like New York, Los Angeles, and Essex County, N.J. But as a share of the population, the coronavirus has been similarly unsparing in many Southern communities. In sparsely populated Claiborne County, Miss., on the floodplains of the Mississippi River, 30 residents – about 1 in 300 – had died as of early March. In East Feliciana Parish, La., north of Baton Rouge, with 106 deaths, about 1 in 180 had died by then.

“It’s just math. If the population is more obese and obesity clearly contributes to worse outcomes, then neighborhoods, cities, states and countries that are more obese will have a greater toll from COVID,” said Dr. James de Lemos, MD, a professor of internal medicine at UT Southwestern Medical Center in Dallas who led a study of hospitalized COVID patients published in the medical journal Circulation.

And, because in the U.S. obesity rates tend to be relatively high among African Americans and Latinos who are poor, with diminished access to health care, “it’s a triple whammy,” Dr. de Lemos said. “All these things intersect.”

Poverty and limited access to medical care are common features in the South, where residents like Michelle Antonyshyn, a former registered nurse and mother of seven in Salem, Ark., say they are afraid of the virus. Ms. Antonyshyn, 49, has obesity and debilitating pain in her knees and back, though she does not have high blood pressure or diabetes, two underlying conditions that federal health officials have determined are added risk factors for severe cases of COVID-19.

Still, she said, she “was very concerned just knowing that being obese puts you more at risk for bad outcomes such as being on a ventilator and death.” As a precaution, Ms. Antonyshyn said, she and her large brood locked down early and stopped attending church services in person, watching online instead.

“It’s not the same as having fellowship, but the risk for me was enough,” said Ms. Antonyshyn.

Governors throughout the South seem to recognize that weight can contribute to COVID-19 complications and have pushed for vaccine eligibility rules that prioritize obesity. But on the ground, local health officials are girding for having to tell newly eligible people who qualify as obese that there aren’t enough shots to go around.

In Port Gibson, Miss., Mheja Williams, MD, medical director of the Claiborne County Family Health Center, has been receiving barely enough doses to inoculate the health workers and oldest seniors in her county of 9,600. One week in early February, she received 100 doses.

Obesity and extreme obesity are endemic in Claiborne County, and health officials say the “normalization” of obesity means people often don’t register their weight as a risk factor, whether for COVID or other health issues. The risks are exacerbated by a general flouting of pandemic etiquette: Dr. Williams said that middle-aged and younger residents are not especially vigilant about physical distancing and that mask use is rare.

The rise of obesity in the United States is well documented over the past half-century, as the nation turned from a diet of fruits, vegetables and limited meats to one laden with ultra-processed foods and rich with salt, fat, sugar, and flavorings, along with copious amounts of meat, fast food, and soda. The U.S. has generally led the global obesity race, setting records as even toddlers and young children grew implausibly, dangerously overweight.

Well before COVID, obesity was a leading cause of preventable death in the United States. The National Institutes of Health declared it a disease in 1998, one that fosters heart disease, stroke, type 2 diabetes, and breast, colon, and other cancers.

Researchers say it is no coincidence that nations like the United States, the United Kingdom, and Italy, with relatively high obesity rates, have proved particularly vulnerable to the novel coronavirus.

They believe the virus may exploit underlying metabolic and physiological impairments that often exist in concert with obesity. Extra fat can lead to a cascade of metabolic disruptions, chronic systemic inflammation, and hormonal dysregulation that may thwart the body’s response to infection.

Other respiratory viruses, like influenza and SARS, which appeared in China in 2002, rely on cholesterol to spread enveloped RNA virus to neighboring cells, and researchers have proposed that a similar mechanism may play a role in the spread of the novel coronavirus.

There are also practical problems for coronavirus patients with obesity admitted to the hospital. They can be more difficult to intubate because of excess central weight pressing down on the diaphragm, making breathing with infected lungs even more difficult.

Physicians who specialize in treating patients with obesity say public health officials need to be more forthright and urgent in their messaging, telegraphing the risks of this COVID era.

“It should be explicit and direct,” said Fatima Stanford, MD, an obesity medicine specialist at Massachusetts General Hospital, Boston, and a Harvard Medical School instructor.

Dr. Stanford denounces the fat-shaming and bullying that people with obesity often experience. But telling patients – and the public – that obesity increases the risk of hospitalization and death is crucial, she said.

“I don’t think it’s stigmatizing,” she said. “If you tell them in that way, it’s not to scare you, it’s just giving information. Sometimes people are just unaware.”



KHN (Kaiser Health News) is a national newsroom that produces in-depth journalism about health issues. Together with Policy Analysis and Polling, KHN is one of the three major operating programs at KFF (Kaiser Family Foundation). KFF is an endowed nonprofit organization providing information on health issues to the nation.

In January, as Mississippi health officials planned for their incoming shipments of COVID-19 vaccine, they assessed the state’s most vulnerable: health care workers, of course, and elderly people in nursing homes. But among those who needed urgent protection from the virus ripping across the Magnolia State were 1 million Mississippians with obesity.

Obesity and weight-related illnesses have been deadly liabilities in the COVID era. A report released this month by the World Obesity Federation found that increased body weight is the second-greatest predictor of COVID-related hospitalization and death across the globe, trailing only old age as a risk factor.

As a fixture of life in the American South – home to 9 of the nation’s 12 heaviest states – obesity is playing a role not only in COVID outcomes, but in the calculus of the vaccination rollout. Mississippi was one of the first states to add a body mass index of 30 or more (a rough gauge of obesity tied to height and weight) to the list of qualifying medical conditions for a shot. About 40% of the state’s adults meet that definition, according to federal health survey data, and combined with the risk group already eligible for vaccination – residents 65 and older – that means fully half of Mississippi’s adults are entitled to vie for a restricted allotment of shots.

At least 29 states have green-lighted obesity for inclusion in the first phases of the vaccine rollout, according to KFF – a vast widening of eligibility that has the potential to overwhelm government efforts and heighten competition for scarce doses.

“We have a lifesaving intervention, and we don’t have enough of it,” said Jen Kates, PhD, director of global health and HIV policy for Kaiser Family Foundation. “Hard choices are being made about who should go first, and there is no right answer.”

The sheer prevalence of obesity in the nation – two in three Americans exceed what is considered a healthy weight – was a public health concern well before the pandemic. But COVID-19 dramatically fast-tracked the discussion from warnings about the long-term damage excess fat tissue can pose to heart, lung and metabolic functions to far more immediate threats.

In the United Kingdom, for example, overweight COVID patients were 67% more likely to require intensive care, and obese patients three times likelier, according to the World Obesity Federation report. A Centers for Disease Control and Prevention study released Monday found a similar trend among U.S. patients and noted that the risk of COVID-related hospitalization, ventilation and death increased with patients’ obesity level.

The counties that hug the southern Mississippi River are home to some of the most concentrated pockets of extreme obesity in the United States. Coronavirus infections began surging in Southern states early last summer, and hospitalizations rose in step.

Deaths in rural stretches of Arkansas, Louisiana, Mississippi, and Tennessee have been overshadowed by the sheer number of deaths in metropolitan areas like New York, Los Angeles, and Essex County, N.J. But as a share of the population, the coronavirus has been similarly unsparing in many Southern communities. In sparsely populated Claiborne County, Miss., on the floodplains of the Mississippi River, 30 residents – about 1 in 300 – had died as of early March. In East Feliciana Parish, La., north of Baton Rouge, with 106 deaths, about 1 in 180 had died by then.

“It’s just math. If the population is more obese and obesity clearly contributes to worse outcomes, then neighborhoods, cities, states and countries that are more obese will have a greater toll from COVID,” said Dr. James de Lemos, MD, a professor of internal medicine at UT Southwestern Medical Center in Dallas who led a study of hospitalized COVID patients published in the medical journal Circulation.

And, because in the U.S. obesity rates tend to be relatively high among African Americans and Latinos who are poor, with diminished access to health care, “it’s a triple whammy,” Dr. de Lemos said. “All these things intersect.”

Poverty and limited access to medical care are common features in the South, where residents like Michelle Antonyshyn, a former registered nurse and mother of seven in Salem, Ark., say they are afraid of the virus. Ms. Antonyshyn, 49, has obesity and debilitating pain in her knees and back, though she does not have high blood pressure or diabetes, two underlying conditions that federal health officials have determined are added risk factors for severe cases of COVID-19.

Still, she said, she “was very concerned just knowing that being obese puts you more at risk for bad outcomes such as being on a ventilator and death.” As a precaution, Ms. Antonyshyn said, she and her large brood locked down early and stopped attending church services in person, watching online instead.

“It’s not the same as having fellowship, but the risk for me was enough,” said Ms. Antonyshyn.

Governors throughout the South seem to recognize that weight can contribute to COVID-19 complications and have pushed for vaccine eligibility rules that prioritize obesity. But on the ground, local health officials are girding for having to tell newly eligible people who qualify as obese that there aren’t enough shots to go around.

In Port Gibson, Miss., Mheja Williams, MD, medical director of the Claiborne County Family Health Center, has been receiving barely enough doses to inoculate the health workers and oldest seniors in her county of 9,600. One week in early February, she received 100 doses.

Obesity and extreme obesity are endemic in Claiborne County, and health officials say the “normalization” of obesity means people often don’t register their weight as a risk factor, whether for COVID or other health issues. The risks are exacerbated by a general flouting of pandemic etiquette: Dr. Williams said that middle-aged and younger residents are not especially vigilant about physical distancing and that mask use is rare.

The rise of obesity in the United States is well documented over the past half-century, as the nation turned from a diet of fruits, vegetables and limited meats to one laden with ultra-processed foods and rich with salt, fat, sugar, and flavorings, along with copious amounts of meat, fast food, and soda. The U.S. has generally led the global obesity race, setting records as even toddlers and young children grew implausibly, dangerously overweight.

Well before COVID, obesity was a leading cause of preventable death in the United States. The National Institutes of Health declared it a disease in 1998, one that fosters heart disease, stroke, type 2 diabetes, and breast, colon, and other cancers.

Researchers say it is no coincidence that nations like the United States, the United Kingdom, and Italy, with relatively high obesity rates, have proved particularly vulnerable to the novel coronavirus.

They believe the virus may exploit underlying metabolic and physiological impairments that often exist in concert with obesity. Extra fat can lead to a cascade of metabolic disruptions, chronic systemic inflammation, and hormonal dysregulation that may thwart the body’s response to infection.

Other respiratory viruses, like influenza and SARS, which appeared in China in 2002, rely on cholesterol to spread enveloped RNA virus to neighboring cells, and researchers have proposed that a similar mechanism may play a role in the spread of the novel coronavirus.

There are also practical problems for coronavirus patients with obesity admitted to the hospital. They can be more difficult to intubate because of excess central weight pressing down on the diaphragm, making breathing with infected lungs even more difficult.

Physicians who specialize in treating patients with obesity say public health officials need to be more forthright and urgent in their messaging, telegraphing the risks of this COVID era.

“It should be explicit and direct,” said Fatima Stanford, MD, an obesity medicine specialist at Massachusetts General Hospital, Boston, and a Harvard Medical School instructor.

Dr. Stanford denounces the fat-shaming and bullying that people with obesity often experience. But telling patients – and the public – that obesity increases the risk of hospitalization and death is crucial, she said.

“I don’t think it’s stigmatizing,” she said. “If you tell them in that way, it’s not to scare you, it’s just giving information. Sometimes people are just unaware.”



KHN (Kaiser Health News) is a national newsroom that produces in-depth journalism about health issues. Together with Policy Analysis and Polling, KHN is one of the three major operating programs at KFF (Kaiser Family Foundation). KFF is an endowed nonprofit organization providing information on health issues to the nation.

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Doctors Found Jet Fuel in Veteran’s Lungs. He Can’t Get Full Benefits.

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Tue, 03/30/2021 - 10:47

 

The lungs Bill Thompson was born with told a gruesome, harrowing and unmistakable tale to Dr. Anthony Szema when he analyzed them and found the black spots, scarring, partially combusted jet fuel and metal inside.

The retired Army staff sergeant had suffered catastrophic lung damage from breathing incinerated waste burned in massive open-air pits and probably other irritants during his tour of duty in Iraq.

“There’s black spots that are burns, particles all over; there’s metal. It was all scarred,” said Szema, a pulmonologist and professor who studies toxic exposures and examined Thompson’s preserved lung tissue. “There was no gas exchange anywhere in that lung.”

Thompson is still alive, surviving on his second transplanted set of lungs. Yet the story burned into the veteran’s internal organs is not one that has been entirely convincing to the U.S. government.

The military has not linked the burn pits to illness. That means many who were exposed to burn pits and are sick do not qualify for benefits under any existing program.

Retirement and health benefits for members of the military depend on factors like length of service, active or reserve status, deployments to combat zones and whether the military considers specific injuries or illnesses to be service-related. Thompson has been able to get care through the Department of Veterans Affairs for his lung disease but has not been able to secure other benefits, like early retirement pay.

“I was denied my Army retirement because if it was not a combat action, then I don’t receive that retirement,” Thompson said at a Senate Veterans’ Affairs Committee hearing last week on service members’ exposures to toxic substances.

Thompson is one of at least 3.5 million veterans since 2001 who have served in war zones where the U.S. military decided to dispose of its trash by burning it, according to VA estimates.

It’s not clear how many people within that population have gotten sick from exposure. Only a small fraction — 234,000 — have enrolled in the VA’s online burn pit registry. Veterans’ advocacy groups have said the majority of claims to the agency stemming from toxic exposures are denied, even as most former service members report contacts with toxins in their deployments.

Soldiers returning from tours in the global war on terror have reported debilitating illnesses almost from its beginning, but got little traction with the military. This year, though, the likelihood of congressional action is high, with Democrats expressing interest and a president who suspects burn pits are to blame for his son’s death.

President Joe Biden’s son Beau died of brain cancer in 2015 at age 46. He had deployed to Iraq in two sites with burn pits — at Baghdad and Balad — around the same time Thompson was at Camp Striker, near the Baghdad airport.

“Because of exposure to burn pits — in my view, I can’t prove it yet — he came back with stage 4 glioblastoma,” Biden said in a 2019 speech.

In testimony at the March 10 hearing, Shane Liermann, who works for the group Disabled American Veterans, told the committee that 78% of burn pit claims are denied. “Part of the problem is VA is not recognizing that exposure as being toxic exposures,” Liermann said.

Aleks Morosky, with the Wounded Warrior Project, said that in his group’s survey of 28,000 veterans last year, 71% said they had “definitely” been exposed to toxic substances or hazardous chemicals, and 18% said they had “probably” been exposed. Half of those people rated their health as poor or fair. Only about 16% of the service members who believed they had suffered exposure said they got treatment from the VA, and 11% said they were denied treatment.

Thompson, who is 49, said care for his lung disease is often slow and sometimes denied. It took the VA three years to approve an air purifier for his home to filter out allergens, and the VA refused to help pay for the removal of dust-trapping carpets, he said.

Thompson’s presence at the hearing, though, was not just meant to put the spotlight on the VA. The military’s entire approach to toxic exposure is a morass that leaves ill soldiers and veterans like Thompson trying to navigate a bureaucracy more labyrinthine than the Pentagon’s corridors.

After Thompson was shipped back to Fort Stewart in Georgia, his medical ordeal was at first addressed within the military system, including a year at Walter Reed National Military Medical Center in Bethesda, Maryland, where doctors found his lungs filled with titanium, magnesium, iron and silica.

Yet he said he didn’t qualify for the Army’s traumatic-injury insurance program, which might have helped him pay to retrofit his home in West Virginia. And he can’t get his military retirement pay until he’s 60.

“I may not live to be age 60. I turn 50 this year,” Thompson said.

Illustrating the problem, several officials at the hearing with the Department of Defense, the Army and the National Guard were unable to explain why Thompson — with 23 years of service between the Guard and Army — might have such a hard time qualifying for retirement benefits when the evidence of his lungs and the findings of the Army’s own doctors are so vivid and extreme.

For advocates who have been working on the problem for decades, it reminds them all too vividly of Agent Orange, which the military is still coming to grips with.

“It’s already been, since the first Persian Gulf [War] — we’re talking 30 years — and since burn pits were again active, since 2001,” said Liermann. “We’re way behind the curve here.”

Although Congress has done relatively little to deal with burn pits, many members seem to at least be thinking along the same lines. The Senate Veterans’ Affairs hearing promised to be something of a kickoff to a year when lawmakers are poised to offer a slew of bills designed to confront the military’s inability to care for service members poisoned during their deployments.

“Make no mistake about it,” said the committee chairman, Sen. Jon Tester (D-Mont.). “We hold these hearings for two reasons: to gather information for the committee members and to help educate the VA that they might take action before Congress does.”

Republicans have also shown growing interest in the problem, offering targeted bills to ensure a handful of toxin-related diseases are covered by the VA.

At the hearing, conservative freshman Sen. Tommy Tuberville (R-Ala.) seemed especially moved.

“We got to do a better job of taking care of our young people,” Tuberville said. “If we’re going to go to war, we got to understand we got to pay the price for it on both ends.”

There is also likely to be high-profile support and attention when revised legislation starts rolling out this spring.

The broadest bill likely to be offered was first introduced by Sen. Kirsten Gillibrand (D-N.Y.) in the Senate and Rep. Raul Ruiz (D-Calif.) in the House in late 2019, with a boost from former “Daily Show” host Jon Stewart and a cadre of 9/11 responders who are turning their attention to toxic exposures.

Indeed, Ruiz and Gillibrand’s legislation is modeled in part on the 9/11 health act that passed in 2015. The burn pit bill would remove the burden of proving a service-related connection.

It would vastly simplify the lives of people like Thompson.

“I am a warrior of the United States of America. I gave my lungs for my country,” Thompson said.

He was cut off before he could finish, but his prepared remarks concluded, “Hopefully, after hearing my story, it will bring awareness for not only me but others who are battling the same or similar injuries related to burn pit exposures from Iraq or Afghanistan.”

KHN (Kaiser Health News) is a national newsroom that produces in-depth journalism about health issues. Together with Policy Analysis and Polling, KHN is one of the three major operating programs at KFF (Kaiser Family Foundation). KFF is an endowed nonprofit organization providing information on health issues to the nation.

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The lungs Bill Thompson was born with told a gruesome, harrowing and unmistakable tale to Dr. Anthony Szema when he analyzed them and found the black spots, scarring, partially combusted jet fuel and metal inside.

The retired Army staff sergeant had suffered catastrophic lung damage from breathing incinerated waste burned in massive open-air pits and probably other irritants during his tour of duty in Iraq.

“There’s black spots that are burns, particles all over; there’s metal. It was all scarred,” said Szema, a pulmonologist and professor who studies toxic exposures and examined Thompson’s preserved lung tissue. “There was no gas exchange anywhere in that lung.”

Thompson is still alive, surviving on his second transplanted set of lungs. Yet the story burned into the veteran’s internal organs is not one that has been entirely convincing to the U.S. government.

The military has not linked the burn pits to illness. That means many who were exposed to burn pits and are sick do not qualify for benefits under any existing program.

Retirement and health benefits for members of the military depend on factors like length of service, active or reserve status, deployments to combat zones and whether the military considers specific injuries or illnesses to be service-related. Thompson has been able to get care through the Department of Veterans Affairs for his lung disease but has not been able to secure other benefits, like early retirement pay.

“I was denied my Army retirement because if it was not a combat action, then I don’t receive that retirement,” Thompson said at a Senate Veterans’ Affairs Committee hearing last week on service members’ exposures to toxic substances.

Thompson is one of at least 3.5 million veterans since 2001 who have served in war zones where the U.S. military decided to dispose of its trash by burning it, according to VA estimates.

It’s not clear how many people within that population have gotten sick from exposure. Only a small fraction — 234,000 — have enrolled in the VA’s online burn pit registry. Veterans’ advocacy groups have said the majority of claims to the agency stemming from toxic exposures are denied, even as most former service members report contacts with toxins in their deployments.

Soldiers returning from tours in the global war on terror have reported debilitating illnesses almost from its beginning, but got little traction with the military. This year, though, the likelihood of congressional action is high, with Democrats expressing interest and a president who suspects burn pits are to blame for his son’s death.

President Joe Biden’s son Beau died of brain cancer in 2015 at age 46. He had deployed to Iraq in two sites with burn pits — at Baghdad and Balad — around the same time Thompson was at Camp Striker, near the Baghdad airport.

“Because of exposure to burn pits — in my view, I can’t prove it yet — he came back with stage 4 glioblastoma,” Biden said in a 2019 speech.

In testimony at the March 10 hearing, Shane Liermann, who works for the group Disabled American Veterans, told the committee that 78% of burn pit claims are denied. “Part of the problem is VA is not recognizing that exposure as being toxic exposures,” Liermann said.

Aleks Morosky, with the Wounded Warrior Project, said that in his group’s survey of 28,000 veterans last year, 71% said they had “definitely” been exposed to toxic substances or hazardous chemicals, and 18% said they had “probably” been exposed. Half of those people rated their health as poor or fair. Only about 16% of the service members who believed they had suffered exposure said they got treatment from the VA, and 11% said they were denied treatment.

Thompson, who is 49, said care for his lung disease is often slow and sometimes denied. It took the VA three years to approve an air purifier for his home to filter out allergens, and the VA refused to help pay for the removal of dust-trapping carpets, he said.

Thompson’s presence at the hearing, though, was not just meant to put the spotlight on the VA. The military’s entire approach to toxic exposure is a morass that leaves ill soldiers and veterans like Thompson trying to navigate a bureaucracy more labyrinthine than the Pentagon’s corridors.

After Thompson was shipped back to Fort Stewart in Georgia, his medical ordeal was at first addressed within the military system, including a year at Walter Reed National Military Medical Center in Bethesda, Maryland, where doctors found his lungs filled with titanium, magnesium, iron and silica.

Yet he said he didn’t qualify for the Army’s traumatic-injury insurance program, which might have helped him pay to retrofit his home in West Virginia. And he can’t get his military retirement pay until he’s 60.

“I may not live to be age 60. I turn 50 this year,” Thompson said.

Illustrating the problem, several officials at the hearing with the Department of Defense, the Army and the National Guard were unable to explain why Thompson — with 23 years of service between the Guard and Army — might have such a hard time qualifying for retirement benefits when the evidence of his lungs and the findings of the Army’s own doctors are so vivid and extreme.

For advocates who have been working on the problem for decades, it reminds them all too vividly of Agent Orange, which the military is still coming to grips with.

“It’s already been, since the first Persian Gulf [War] — we’re talking 30 years — and since burn pits were again active, since 2001,” said Liermann. “We’re way behind the curve here.”

Although Congress has done relatively little to deal with burn pits, many members seem to at least be thinking along the same lines. The Senate Veterans’ Affairs hearing promised to be something of a kickoff to a year when lawmakers are poised to offer a slew of bills designed to confront the military’s inability to care for service members poisoned during their deployments.

“Make no mistake about it,” said the committee chairman, Sen. Jon Tester (D-Mont.). “We hold these hearings for two reasons: to gather information for the committee members and to help educate the VA that they might take action before Congress does.”

Republicans have also shown growing interest in the problem, offering targeted bills to ensure a handful of toxin-related diseases are covered by the VA.

At the hearing, conservative freshman Sen. Tommy Tuberville (R-Ala.) seemed especially moved.

“We got to do a better job of taking care of our young people,” Tuberville said. “If we’re going to go to war, we got to understand we got to pay the price for it on both ends.”

There is also likely to be high-profile support and attention when revised legislation starts rolling out this spring.

The broadest bill likely to be offered was first introduced by Sen. Kirsten Gillibrand (D-N.Y.) in the Senate and Rep. Raul Ruiz (D-Calif.) in the House in late 2019, with a boost from former “Daily Show” host Jon Stewart and a cadre of 9/11 responders who are turning their attention to toxic exposures.

Indeed, Ruiz and Gillibrand’s legislation is modeled in part on the 9/11 health act that passed in 2015. The burn pit bill would remove the burden of proving a service-related connection.

It would vastly simplify the lives of people like Thompson.

“I am a warrior of the United States of America. I gave my lungs for my country,” Thompson said.

He was cut off before he could finish, but his prepared remarks concluded, “Hopefully, after hearing my story, it will bring awareness for not only me but others who are battling the same or similar injuries related to burn pit exposures from Iraq or Afghanistan.”

KHN (Kaiser Health News) is a national newsroom that produces in-depth journalism about health issues. Together with Policy Analysis and Polling, KHN is one of the three major operating programs at KFF (Kaiser Family Foundation). KFF is an endowed nonprofit organization providing information on health issues to the nation.

USE OUR CONTENT

This story can be republished for free (details).

Subscribe to KHN's free Morning Briefing.

 

The lungs Bill Thompson was born with told a gruesome, harrowing and unmistakable tale to Dr. Anthony Szema when he analyzed them and found the black spots, scarring, partially combusted jet fuel and metal inside.

The retired Army staff sergeant had suffered catastrophic lung damage from breathing incinerated waste burned in massive open-air pits and probably other irritants during his tour of duty in Iraq.

“There’s black spots that are burns, particles all over; there’s metal. It was all scarred,” said Szema, a pulmonologist and professor who studies toxic exposures and examined Thompson’s preserved lung tissue. “There was no gas exchange anywhere in that lung.”

Thompson is still alive, surviving on his second transplanted set of lungs. Yet the story burned into the veteran’s internal organs is not one that has been entirely convincing to the U.S. government.

The military has not linked the burn pits to illness. That means many who were exposed to burn pits and are sick do not qualify for benefits under any existing program.

Retirement and health benefits for members of the military depend on factors like length of service, active or reserve status, deployments to combat zones and whether the military considers specific injuries or illnesses to be service-related. Thompson has been able to get care through the Department of Veterans Affairs for his lung disease but has not been able to secure other benefits, like early retirement pay.

“I was denied my Army retirement because if it was not a combat action, then I don’t receive that retirement,” Thompson said at a Senate Veterans’ Affairs Committee hearing last week on service members’ exposures to toxic substances.

Thompson is one of at least 3.5 million veterans since 2001 who have served in war zones where the U.S. military decided to dispose of its trash by burning it, according to VA estimates.

It’s not clear how many people within that population have gotten sick from exposure. Only a small fraction — 234,000 — have enrolled in the VA’s online burn pit registry. Veterans’ advocacy groups have said the majority of claims to the agency stemming from toxic exposures are denied, even as most former service members report contacts with toxins in their deployments.

Soldiers returning from tours in the global war on terror have reported debilitating illnesses almost from its beginning, but got little traction with the military. This year, though, the likelihood of congressional action is high, with Democrats expressing interest and a president who suspects burn pits are to blame for his son’s death.

President Joe Biden’s son Beau died of brain cancer in 2015 at age 46. He had deployed to Iraq in two sites with burn pits — at Baghdad and Balad — around the same time Thompson was at Camp Striker, near the Baghdad airport.

“Because of exposure to burn pits — in my view, I can’t prove it yet — he came back with stage 4 glioblastoma,” Biden said in a 2019 speech.

In testimony at the March 10 hearing, Shane Liermann, who works for the group Disabled American Veterans, told the committee that 78% of burn pit claims are denied. “Part of the problem is VA is not recognizing that exposure as being toxic exposures,” Liermann said.

Aleks Morosky, with the Wounded Warrior Project, said that in his group’s survey of 28,000 veterans last year, 71% said they had “definitely” been exposed to toxic substances or hazardous chemicals, and 18% said they had “probably” been exposed. Half of those people rated their health as poor or fair. Only about 16% of the service members who believed they had suffered exposure said they got treatment from the VA, and 11% said they were denied treatment.

Thompson, who is 49, said care for his lung disease is often slow and sometimes denied. It took the VA three years to approve an air purifier for his home to filter out allergens, and the VA refused to help pay for the removal of dust-trapping carpets, he said.

Thompson’s presence at the hearing, though, was not just meant to put the spotlight on the VA. The military’s entire approach to toxic exposure is a morass that leaves ill soldiers and veterans like Thompson trying to navigate a bureaucracy more labyrinthine than the Pentagon’s corridors.

After Thompson was shipped back to Fort Stewart in Georgia, his medical ordeal was at first addressed within the military system, including a year at Walter Reed National Military Medical Center in Bethesda, Maryland, where doctors found his lungs filled with titanium, magnesium, iron and silica.

Yet he said he didn’t qualify for the Army’s traumatic-injury insurance program, which might have helped him pay to retrofit his home in West Virginia. And he can’t get his military retirement pay until he’s 60.

“I may not live to be age 60. I turn 50 this year,” Thompson said.

Illustrating the problem, several officials at the hearing with the Department of Defense, the Army and the National Guard were unable to explain why Thompson — with 23 years of service between the Guard and Army — might have such a hard time qualifying for retirement benefits when the evidence of his lungs and the findings of the Army’s own doctors are so vivid and extreme.

For advocates who have been working on the problem for decades, it reminds them all too vividly of Agent Orange, which the military is still coming to grips with.

“It’s already been, since the first Persian Gulf [War] — we’re talking 30 years — and since burn pits were again active, since 2001,” said Liermann. “We’re way behind the curve here.”

Although Congress has done relatively little to deal with burn pits, many members seem to at least be thinking along the same lines. The Senate Veterans’ Affairs hearing promised to be something of a kickoff to a year when lawmakers are poised to offer a slew of bills designed to confront the military’s inability to care for service members poisoned during their deployments.

“Make no mistake about it,” said the committee chairman, Sen. Jon Tester (D-Mont.). “We hold these hearings for two reasons: to gather information for the committee members and to help educate the VA that they might take action before Congress does.”

Republicans have also shown growing interest in the problem, offering targeted bills to ensure a handful of toxin-related diseases are covered by the VA.

At the hearing, conservative freshman Sen. Tommy Tuberville (R-Ala.) seemed especially moved.

“We got to do a better job of taking care of our young people,” Tuberville said. “If we’re going to go to war, we got to understand we got to pay the price for it on both ends.”

There is also likely to be high-profile support and attention when revised legislation starts rolling out this spring.

The broadest bill likely to be offered was first introduced by Sen. Kirsten Gillibrand (D-N.Y.) in the Senate and Rep. Raul Ruiz (D-Calif.) in the House in late 2019, with a boost from former “Daily Show” host Jon Stewart and a cadre of 9/11 responders who are turning their attention to toxic exposures.

Indeed, Ruiz and Gillibrand’s legislation is modeled in part on the 9/11 health act that passed in 2015. The burn pit bill would remove the burden of proving a service-related connection.

It would vastly simplify the lives of people like Thompson.

“I am a warrior of the United States of America. I gave my lungs for my country,” Thompson said.

He was cut off before he could finish, but his prepared remarks concluded, “Hopefully, after hearing my story, it will bring awareness for not only me but others who are battling the same or similar injuries related to burn pit exposures from Iraq or Afghanistan.”

KHN (Kaiser Health News) is a national newsroom that produces in-depth journalism about health issues. Together with Policy Analysis and Polling, KHN is one of the three major operating programs at KFF (Kaiser Family Foundation). KFF is an endowed nonprofit organization providing information on health issues to the nation.

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COVID-19 virus reinfections rare; riskiest after age 65

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The first large study of its kind reveals that SARS-CoV-2 reinfections remain rare, although people older than 65 are at higher risk.

When researchers analyzed test results of 4 million people in Denmark, they found that less than 1% of those who tested positive experienced reinfection.

Initial infection was associated with about 80% protection overall against getting SARS-CoV-2 again. However, among those older than 65, the protection plummeted to 47%.

“Not everybody is protected against reinfection after a first infection. Older people are at higher risk of catching it again,” co–lead author Daniela Michlmayr, PhD, said in an interview. “Our findings emphasize the importance of policies to protect the elderly and of adhering to infection control measures and restrictions, even if previously infected with COVID-19.”
 

Verifying the need for vaccination

“The findings also highlight the need to vaccinate people who had COVID-19 before, as natural immunity to infection – especially among the elderly 65 and older – cannot be relied upon,” added Dr. Michlmayr, a researcher in the department of bacteria, parasites, and fungi at the Staten Serums Institut, Copenhagen.

The population-based observational study was published online March 17 in The Lancet.

“The findings make sense, as patients who are immunocompromised or of advanced age may not mount an immune response that is as long-lasting,” David Hirschwerk, MD, said in an interview. “It does underscore the importance of vaccination for people of more advanced age, even if they previously were infected with COVID.

“For those who were infected last spring and have not yet been vaccinated, this helps to support the value of still pursuing the vaccine,” added Dr. Hirschwerk, an infectious disease specialist at Northwell Health in Manhasset, N.Y.

Evidence on reinfection risk was limited prior to this study. “Little is known about protection against SARS-CoV-2 repeat infections, but two studies in the UK have found that immunity could last at least 5 to 6 months after infection,” the authors noted.

Along with co–lead author Christian Holm Hansen, PhD, Dr. Michlmayr and colleagues found that 2.11% of 525,339 individuals tested positive for SARS-CoV-2 during the first surge in Denmark from March to May 2020. Within this group, 0.65% tested positive during a second surge from September to December.

By the end of 2020, more than 10 million people had undergone free polymerase chain reaction testing by the Danish government or through the national TestDenmark program.

“My overall take is that it is great to have such a big dataset looking at this question,” E. John Wherry, PhD, said in an interview. The findings support “what we’ve seen in previous, smaller studies.”

Natural protection against reinfection of approximately 80% “is not as good as the vaccines, but not bad,” added Dr. Wherry, director of the Institute for Immunology at the University of Pennsylvania, Philadelphia.
 

Age alters immunity?

“Our finding that older people were more likely than younger people to test positive again if they had already tested positive could be explained by natural age-related changes in the immune system of older adults, also referred to as immune senescence,” the authors noted.

 

 

The investigators found no significant differences in reinfection rates between women and men.

As with the previous research, this study also indicates that an initial bout with SARS-CoV-2 infection appears to confer protection for at least 6 months. The researchers found no significant differences between people who were followed for 3-6 months and those followed for 7 months or longer.
 

Variants not included

To account for possible bias among people who got tested repeatedly, Dr. Michlmayr and colleagues performed a sensitivity analysis in a subgroup. They assessed reinfection rates among people who underwent testing frequently and routinely – nurses, doctors, social workers, and health care assistants – and found that 1.2% tested positive a second time during the second surge.

A limitation of the study was the inability to correlate symptoms with risk for reinfection. Also, the researchers did not account for SARS-CoV-2 variants, noting that “during the study period, such variants were not yet established in Denmark; although into 2021 this pattern is changing.”

Asked to speculate whether the results would be different had the study accounted for variants, Dr. Hirschwerk said, “It depends upon the variant, but certainly for the B.1.351 variant, there already has been data clearly demonstrating risk of reinfection with SARS-CoV-2 despite prior infection with the original strain of virus.”

The emergence of SARS-CoV-2 variants of concern that could escape natural and vaccine-related immunity “complicates matters further,” Rosemary J. Boyton, MBBS, and Daniel M. Altmann, PhD, both of Imperial College London, wrote in an accompanying comment in The Lancet.

“Emerging variants of concern might shift immunity below a protective margin, prompting the need for updated vaccines. Interestingly, vaccine responses even after single dose are substantially enhanced in individuals with a history of infection with SARS-CoV-2,” they added.

The current study confirms that “the hope of protective immunity through natural infections might not be within our reach, and a global vaccination program with high efficacy vaccines is the enduring solution,” Dr. Boyton and Dr. Altmann noted.

 

 

Cause for alarm?

Despite evidence that reinfection is relatively rare, “many will find the data reported by Hansen and colleagues about protection through natural infection relatively alarming,” Dr. Boyton and Dr. Altmann wrote in their commentary. The 80% protection rate from reinfection in general and the 47% rate among people aged 65 and older “are more concerning figures than offered by previous studies.”

Vaccines appear to provide better quality, quantity, and durability of protection against repeated infection – measured in terms of neutralizing antibodies and T cells – compared with previous infection with SARS-CoV-2, Dr. Boyton and Dr. Altmann wrote.
 

More research needed

The duration of natural protection against reinfection remains an unanswered question, the researchers noted, “because too little time has elapsed since the beginning of the pandemic.”

Future prospective and longitudinal cohort studies coupled with molecular surveillance are needed to characterize antibody titers and waning of protection against repeat infections, the authors noted. Furthermore, more answers are needed regarding how some virus variants might contribute to reinfection risk.

No funding for the study has been reported. Dr. Michlmayr, Dr. Hirschwerk, Dr. Wherry, Dr. Boyton, and Dr. Altmann have disclosed no relevant financial relationships.
 

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

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The first large study of its kind reveals that SARS-CoV-2 reinfections remain rare, although people older than 65 are at higher risk.

When researchers analyzed test results of 4 million people in Denmark, they found that less than 1% of those who tested positive experienced reinfection.

Initial infection was associated with about 80% protection overall against getting SARS-CoV-2 again. However, among those older than 65, the protection plummeted to 47%.

“Not everybody is protected against reinfection after a first infection. Older people are at higher risk of catching it again,” co–lead author Daniela Michlmayr, PhD, said in an interview. “Our findings emphasize the importance of policies to protect the elderly and of adhering to infection control measures and restrictions, even if previously infected with COVID-19.”
 

Verifying the need for vaccination

“The findings also highlight the need to vaccinate people who had COVID-19 before, as natural immunity to infection – especially among the elderly 65 and older – cannot be relied upon,” added Dr. Michlmayr, a researcher in the department of bacteria, parasites, and fungi at the Staten Serums Institut, Copenhagen.

The population-based observational study was published online March 17 in The Lancet.

“The findings make sense, as patients who are immunocompromised or of advanced age may not mount an immune response that is as long-lasting,” David Hirschwerk, MD, said in an interview. “It does underscore the importance of vaccination for people of more advanced age, even if they previously were infected with COVID.

“For those who were infected last spring and have not yet been vaccinated, this helps to support the value of still pursuing the vaccine,” added Dr. Hirschwerk, an infectious disease specialist at Northwell Health in Manhasset, N.Y.

Evidence on reinfection risk was limited prior to this study. “Little is known about protection against SARS-CoV-2 repeat infections, but two studies in the UK have found that immunity could last at least 5 to 6 months after infection,” the authors noted.

Along with co–lead author Christian Holm Hansen, PhD, Dr. Michlmayr and colleagues found that 2.11% of 525,339 individuals tested positive for SARS-CoV-2 during the first surge in Denmark from March to May 2020. Within this group, 0.65% tested positive during a second surge from September to December.

By the end of 2020, more than 10 million people had undergone free polymerase chain reaction testing by the Danish government or through the national TestDenmark program.

“My overall take is that it is great to have such a big dataset looking at this question,” E. John Wherry, PhD, said in an interview. The findings support “what we’ve seen in previous, smaller studies.”

Natural protection against reinfection of approximately 80% “is not as good as the vaccines, but not bad,” added Dr. Wherry, director of the Institute for Immunology at the University of Pennsylvania, Philadelphia.
 

Age alters immunity?

“Our finding that older people were more likely than younger people to test positive again if they had already tested positive could be explained by natural age-related changes in the immune system of older adults, also referred to as immune senescence,” the authors noted.

 

 

The investigators found no significant differences in reinfection rates between women and men.

As with the previous research, this study also indicates that an initial bout with SARS-CoV-2 infection appears to confer protection for at least 6 months. The researchers found no significant differences between people who were followed for 3-6 months and those followed for 7 months or longer.
 

Variants not included

To account for possible bias among people who got tested repeatedly, Dr. Michlmayr and colleagues performed a sensitivity analysis in a subgroup. They assessed reinfection rates among people who underwent testing frequently and routinely – nurses, doctors, social workers, and health care assistants – and found that 1.2% tested positive a second time during the second surge.

A limitation of the study was the inability to correlate symptoms with risk for reinfection. Also, the researchers did not account for SARS-CoV-2 variants, noting that “during the study period, such variants were not yet established in Denmark; although into 2021 this pattern is changing.”

Asked to speculate whether the results would be different had the study accounted for variants, Dr. Hirschwerk said, “It depends upon the variant, but certainly for the B.1.351 variant, there already has been data clearly demonstrating risk of reinfection with SARS-CoV-2 despite prior infection with the original strain of virus.”

The emergence of SARS-CoV-2 variants of concern that could escape natural and vaccine-related immunity “complicates matters further,” Rosemary J. Boyton, MBBS, and Daniel M. Altmann, PhD, both of Imperial College London, wrote in an accompanying comment in The Lancet.

“Emerging variants of concern might shift immunity below a protective margin, prompting the need for updated vaccines. Interestingly, vaccine responses even after single dose are substantially enhanced in individuals with a history of infection with SARS-CoV-2,” they added.

The current study confirms that “the hope of protective immunity through natural infections might not be within our reach, and a global vaccination program with high efficacy vaccines is the enduring solution,” Dr. Boyton and Dr. Altmann noted.

 

 

Cause for alarm?

Despite evidence that reinfection is relatively rare, “many will find the data reported by Hansen and colleagues about protection through natural infection relatively alarming,” Dr. Boyton and Dr. Altmann wrote in their commentary. The 80% protection rate from reinfection in general and the 47% rate among people aged 65 and older “are more concerning figures than offered by previous studies.”

Vaccines appear to provide better quality, quantity, and durability of protection against repeated infection – measured in terms of neutralizing antibodies and T cells – compared with previous infection with SARS-CoV-2, Dr. Boyton and Dr. Altmann wrote.
 

More research needed

The duration of natural protection against reinfection remains an unanswered question, the researchers noted, “because too little time has elapsed since the beginning of the pandemic.”

Future prospective and longitudinal cohort studies coupled with molecular surveillance are needed to characterize antibody titers and waning of protection against repeat infections, the authors noted. Furthermore, more answers are needed regarding how some virus variants might contribute to reinfection risk.

No funding for the study has been reported. Dr. Michlmayr, Dr. Hirschwerk, Dr. Wherry, Dr. Boyton, and Dr. Altmann have disclosed no relevant financial relationships.
 

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

The first large study of its kind reveals that SARS-CoV-2 reinfections remain rare, although people older than 65 are at higher risk.

When researchers analyzed test results of 4 million people in Denmark, they found that less than 1% of those who tested positive experienced reinfection.

Initial infection was associated with about 80% protection overall against getting SARS-CoV-2 again. However, among those older than 65, the protection plummeted to 47%.

“Not everybody is protected against reinfection after a first infection. Older people are at higher risk of catching it again,” co–lead author Daniela Michlmayr, PhD, said in an interview. “Our findings emphasize the importance of policies to protect the elderly and of adhering to infection control measures and restrictions, even if previously infected with COVID-19.”
 

Verifying the need for vaccination

“The findings also highlight the need to vaccinate people who had COVID-19 before, as natural immunity to infection – especially among the elderly 65 and older – cannot be relied upon,” added Dr. Michlmayr, a researcher in the department of bacteria, parasites, and fungi at the Staten Serums Institut, Copenhagen.

The population-based observational study was published online March 17 in The Lancet.

“The findings make sense, as patients who are immunocompromised or of advanced age may not mount an immune response that is as long-lasting,” David Hirschwerk, MD, said in an interview. “It does underscore the importance of vaccination for people of more advanced age, even if they previously were infected with COVID.

“For those who were infected last spring and have not yet been vaccinated, this helps to support the value of still pursuing the vaccine,” added Dr. Hirschwerk, an infectious disease specialist at Northwell Health in Manhasset, N.Y.

Evidence on reinfection risk was limited prior to this study. “Little is known about protection against SARS-CoV-2 repeat infections, but two studies in the UK have found that immunity could last at least 5 to 6 months after infection,” the authors noted.

Along with co–lead author Christian Holm Hansen, PhD, Dr. Michlmayr and colleagues found that 2.11% of 525,339 individuals tested positive for SARS-CoV-2 during the first surge in Denmark from March to May 2020. Within this group, 0.65% tested positive during a second surge from September to December.

By the end of 2020, more than 10 million people had undergone free polymerase chain reaction testing by the Danish government or through the national TestDenmark program.

“My overall take is that it is great to have such a big dataset looking at this question,” E. John Wherry, PhD, said in an interview. The findings support “what we’ve seen in previous, smaller studies.”

Natural protection against reinfection of approximately 80% “is not as good as the vaccines, but not bad,” added Dr. Wherry, director of the Institute for Immunology at the University of Pennsylvania, Philadelphia.
 

Age alters immunity?

“Our finding that older people were more likely than younger people to test positive again if they had already tested positive could be explained by natural age-related changes in the immune system of older adults, also referred to as immune senescence,” the authors noted.

 

 

The investigators found no significant differences in reinfection rates between women and men.

As with the previous research, this study also indicates that an initial bout with SARS-CoV-2 infection appears to confer protection for at least 6 months. The researchers found no significant differences between people who were followed for 3-6 months and those followed for 7 months or longer.
 

Variants not included

To account for possible bias among people who got tested repeatedly, Dr. Michlmayr and colleagues performed a sensitivity analysis in a subgroup. They assessed reinfection rates among people who underwent testing frequently and routinely – nurses, doctors, social workers, and health care assistants – and found that 1.2% tested positive a second time during the second surge.

A limitation of the study was the inability to correlate symptoms with risk for reinfection. Also, the researchers did not account for SARS-CoV-2 variants, noting that “during the study period, such variants were not yet established in Denmark; although into 2021 this pattern is changing.”

Asked to speculate whether the results would be different had the study accounted for variants, Dr. Hirschwerk said, “It depends upon the variant, but certainly for the B.1.351 variant, there already has been data clearly demonstrating risk of reinfection with SARS-CoV-2 despite prior infection with the original strain of virus.”

The emergence of SARS-CoV-2 variants of concern that could escape natural and vaccine-related immunity “complicates matters further,” Rosemary J. Boyton, MBBS, and Daniel M. Altmann, PhD, both of Imperial College London, wrote in an accompanying comment in The Lancet.

“Emerging variants of concern might shift immunity below a protective margin, prompting the need for updated vaccines. Interestingly, vaccine responses even after single dose are substantially enhanced in individuals with a history of infection with SARS-CoV-2,” they added.

The current study confirms that “the hope of protective immunity through natural infections might not be within our reach, and a global vaccination program with high efficacy vaccines is the enduring solution,” Dr. Boyton and Dr. Altmann noted.

 

 

Cause for alarm?

Despite evidence that reinfection is relatively rare, “many will find the data reported by Hansen and colleagues about protection through natural infection relatively alarming,” Dr. Boyton and Dr. Altmann wrote in their commentary. The 80% protection rate from reinfection in general and the 47% rate among people aged 65 and older “are more concerning figures than offered by previous studies.”

Vaccines appear to provide better quality, quantity, and durability of protection against repeated infection – measured in terms of neutralizing antibodies and T cells – compared with previous infection with SARS-CoV-2, Dr. Boyton and Dr. Altmann wrote.
 

More research needed

The duration of natural protection against reinfection remains an unanswered question, the researchers noted, “because too little time has elapsed since the beginning of the pandemic.”

Future prospective and longitudinal cohort studies coupled with molecular surveillance are needed to characterize antibody titers and waning of protection against repeat infections, the authors noted. Furthermore, more answers are needed regarding how some virus variants might contribute to reinfection risk.

No funding for the study has been reported. Dr. Michlmayr, Dr. Hirschwerk, Dr. Wherry, Dr. Boyton, and Dr. Altmann have disclosed no relevant financial relationships.
 

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

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ACTRIMS 2021: Safety and efficacy of disease-modifying therapies in multiple sclerosis

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Tue, 03/23/2021 - 15:24
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ACTRIMS 2021: Safety and efficacy of disease-modifying therapies in multiple sclerosis

In a summary of abstracts presented at the ACTRIMS Forum 2021, Dr. Mark Freedman shares that he and his colleagues found no apparent increased risk of COVID-19 with long-term use of interferon β-1a in patients with multiple sclerosis (MS).

 

Dr. Freedman also highlights several abstracts examining the use of cladribine and ocrelizumab in older patients with MS.

 

A post hoc analysis of lymphocyte subsets in the combined safety populations of CLARITY, CLARITY Extension, and ORACLE-MS found that by week 96, the effects of cladribine tablets 3.5 mg/kg on CD19+ B, CD4+ T, and CD8+ T lymphocytes in younger and older patients with MS were similar, with steady recovery following nadir.

 

Important pivotal trial results

Watch an overview of our Phase 3 clinical trial data and see why you should make KESIMPTA® (ofatumumab) your 1st choice.

This video is sponsored by Novartis

 

Another study on younger and older patients treated with cladribine tablets 3.5 mg/kg found that around a quarter of both groups had transient periods of Grade ≥3 lymphopenia during the study, and the rate of certain infection-related treatment-emergent adverse events was higher in the older patients.

 

A single-center study found that 25% of patients in the older population stopped ocrelizumab, the most common reasons being disease progression and repeated or severe infections.

 

Lastly, an evaluation of older patients with progressive MS found no statistical difference in 2-year clinical endpoints for patients taking ocrelizumab compared to prior to anti-CD20 therapy.

--

Mark S. Freedman, MSc, MD is a Professor, Department of Neurology, University of Ottawa and The Ottawa Hospital Research Institute; and Director, Multiple Sclerosis Research Unit, The Ottawa Hospital–General Campus.

Mark S. Freedman, MSc, MD, has disclosed the following relevant financial relationships:

Serve(d) on the advisory board, board of directors, or other similar groups for: Actelion (Janssen/Johnson and Johnson); Alexion; Atara Biotherapeutics; Bayer Healthcare; Biogen Idec; Celgene; Clene Nanomedicine; GRI Bio; Hoffmann-La Roche; Magenta Therapeutics; Merck Serono; MedDay Pharmaceuticals; Novartis; Sanofi Genzyme; Teva Canada.

Serve(d) as a member of a speakers bureau for: Sanofi Genzyme; EMD Serono.

Received honoraria or consultation fees for: Actelion (Janssen/Johnson and Johnson); Alexion; Biogen Idec; Celgene (BMS); EMD Inc; Sanofi Genzyme; Hoffmann-La Roche; Merck Serono; Novartis; Teva Canada.

Received research or educational grants from: EMD Inc; Hoffmann-La Roche; Sanofi Genzyme Canada.

 

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In a summary of abstracts presented at the ACTRIMS Forum 2021, Dr. Mark Freedman shares that he and his colleagues found no apparent increased risk of COVID-19 with long-term use of interferon β-1a in patients with multiple sclerosis (MS).

 

Dr. Freedman also highlights several abstracts examining the use of cladribine and ocrelizumab in older patients with MS.

 

A post hoc analysis of lymphocyte subsets in the combined safety populations of CLARITY, CLARITY Extension, and ORACLE-MS found that by week 96, the effects of cladribine tablets 3.5 mg/kg on CD19+ B, CD4+ T, and CD8+ T lymphocytes in younger and older patients with MS were similar, with steady recovery following nadir.

 

Important pivotal trial results

Watch an overview of our Phase 3 clinical trial data and see why you should make KESIMPTA® (ofatumumab) your 1st choice.

This video is sponsored by Novartis

 

Another study on younger and older patients treated with cladribine tablets 3.5 mg/kg found that around a quarter of both groups had transient periods of Grade ≥3 lymphopenia during the study, and the rate of certain infection-related treatment-emergent adverse events was higher in the older patients.

 

A single-center study found that 25% of patients in the older population stopped ocrelizumab, the most common reasons being disease progression and repeated or severe infections.

 

Lastly, an evaluation of older patients with progressive MS found no statistical difference in 2-year clinical endpoints for patients taking ocrelizumab compared to prior to anti-CD20 therapy.

--

Mark S. Freedman, MSc, MD is a Professor, Department of Neurology, University of Ottawa and The Ottawa Hospital Research Institute; and Director, Multiple Sclerosis Research Unit, The Ottawa Hospital–General Campus.

Mark S. Freedman, MSc, MD, has disclosed the following relevant financial relationships:

Serve(d) on the advisory board, board of directors, or other similar groups for: Actelion (Janssen/Johnson and Johnson); Alexion; Atara Biotherapeutics; Bayer Healthcare; Biogen Idec; Celgene; Clene Nanomedicine; GRI Bio; Hoffmann-La Roche; Magenta Therapeutics; Merck Serono; MedDay Pharmaceuticals; Novartis; Sanofi Genzyme; Teva Canada.

Serve(d) as a member of a speakers bureau for: Sanofi Genzyme; EMD Serono.

Received honoraria or consultation fees for: Actelion (Janssen/Johnson and Johnson); Alexion; Biogen Idec; Celgene (BMS); EMD Inc; Sanofi Genzyme; Hoffmann-La Roche; Merck Serono; Novartis; Teva Canada.

Received research or educational grants from: EMD Inc; Hoffmann-La Roche; Sanofi Genzyme Canada.

 

In a summary of abstracts presented at the ACTRIMS Forum 2021, Dr. Mark Freedman shares that he and his colleagues found no apparent increased risk of COVID-19 with long-term use of interferon β-1a in patients with multiple sclerosis (MS).

 

Dr. Freedman also highlights several abstracts examining the use of cladribine and ocrelizumab in older patients with MS.

 

A post hoc analysis of lymphocyte subsets in the combined safety populations of CLARITY, CLARITY Extension, and ORACLE-MS found that by week 96, the effects of cladribine tablets 3.5 mg/kg on CD19+ B, CD4+ T, and CD8+ T lymphocytes in younger and older patients with MS were similar, with steady recovery following nadir.

 

Important pivotal trial results

Watch an overview of our Phase 3 clinical trial data and see why you should make KESIMPTA® (ofatumumab) your 1st choice.

This video is sponsored by Novartis

 

Another study on younger and older patients treated with cladribine tablets 3.5 mg/kg found that around a quarter of both groups had transient periods of Grade ≥3 lymphopenia during the study, and the rate of certain infection-related treatment-emergent adverse events was higher in the older patients.

 

A single-center study found that 25% of patients in the older population stopped ocrelizumab, the most common reasons being disease progression and repeated or severe infections.

 

Lastly, an evaluation of older patients with progressive MS found no statistical difference in 2-year clinical endpoints for patients taking ocrelizumab compared to prior to anti-CD20 therapy.

--

Mark S. Freedman, MSc, MD is a Professor, Department of Neurology, University of Ottawa and The Ottawa Hospital Research Institute; and Director, Multiple Sclerosis Research Unit, The Ottawa Hospital–General Campus.

Mark S. Freedman, MSc, MD, has disclosed the following relevant financial relationships:

Serve(d) on the advisory board, board of directors, or other similar groups for: Actelion (Janssen/Johnson and Johnson); Alexion; Atara Biotherapeutics; Bayer Healthcare; Biogen Idec; Celgene; Clene Nanomedicine; GRI Bio; Hoffmann-La Roche; Magenta Therapeutics; Merck Serono; MedDay Pharmaceuticals; Novartis; Sanofi Genzyme; Teva Canada.

Serve(d) as a member of a speakers bureau for: Sanofi Genzyme; EMD Serono.

Received honoraria or consultation fees for: Actelion (Janssen/Johnson and Johnson); Alexion; Biogen Idec; Celgene (BMS); EMD Inc; Sanofi Genzyme; Hoffmann-La Roche; Merck Serono; Novartis; Teva Canada.

Received research or educational grants from: EMD Inc; Hoffmann-La Roche; Sanofi Genzyme Canada.

 

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Updates in multiple sclerosis symptom management from ACTRIMS 2021

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Thu, 04/22/2021 - 15:34
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Updates in multiple sclerosis symptom management from ACTRIMS 2021

Joseph Berger, MD, Associate Chief of the Multiple Sclerosis Division at Perelman School of Medicine at the University of Pennsylvania, presents highlights in multiple sclerosis (MS) symptom management from the ACTRIMS Forum 2021.

 

A follow-up of participants in the self-management program called Fatigue: Take Control found that while patients did not report any significant improvement in fatigue 5-6 years later, they also did not have greater fatigue than at baseline, suggesting that fatigue may not be a progressive symptom.

 

Next, a literature review of efficacy studies in MS rodent models found a complementary pharmacology of CBD and other constituents of nabiximols that may add additional benefit and mitigate THC tolerability.

 

Important pivotal trial results

Watch an overview of our Phase 3 clinical trial data and see why you should make KESIMPTA® (ofatumumab) your 1st choice.

This video is sponsored by Novartis

 

A small study looking at pain prevalence in patients with relapsing-remitting MS (RRMS) found that 76% of patients had a pain syndrome, and 48% had neuropathic pain. The study also found that gabapentin 900 mg per day for 30 days was effective in decreasing pain intensity and frequency.

 

A multi-site study of 282 patients with MS reporting fatigue between 2013 and 2014 found that 21% of patients reported using prescription opiates, 76% of whom reported regular daily use.

 

Lastly, participants in Spasticity: Take Control—an education and lower extremity stretching program—reported significantly decreased pain severity and interference at 6 months, compared with range-of-motion exercises.

--

Professor and Associate Chief, Department of Neurology, Multiple Sclerosis Division. Perelman School of Medicine at the University of Pennsylvania Philadelphia, Pennsylvania.

Joseph R. Berger, MD, has disclosed the following relevant financial relationships:

Received research grant from: Biogen; Roche/Genentech.

Received income in an amount ≥$250 from: Amgen; Biogen; Bristol Myers Squibb; Celgene; Encycle; Excision BioTherapeutics; Dr. Reddy; Genzyme; Inhibikase Therapeutics; Mapi-Pharma; Merck; Morphic Therapeutic; Novartis; Serono.

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Joseph Berger, MD, Associate Chief of the Multiple Sclerosis Division at Perelman School of Medicine at the University of Pennsylvania, presents highlights in multiple sclerosis (MS) symptom management from the ACTRIMS Forum 2021.

 

A follow-up of participants in the self-management program called Fatigue: Take Control found that while patients did not report any significant improvement in fatigue 5-6 years later, they also did not have greater fatigue than at baseline, suggesting that fatigue may not be a progressive symptom.

 

Next, a literature review of efficacy studies in MS rodent models found a complementary pharmacology of CBD and other constituents of nabiximols that may add additional benefit and mitigate THC tolerability.

 

Important pivotal trial results

Watch an overview of our Phase 3 clinical trial data and see why you should make KESIMPTA® (ofatumumab) your 1st choice.

This video is sponsored by Novartis

 

A small study looking at pain prevalence in patients with relapsing-remitting MS (RRMS) found that 76% of patients had a pain syndrome, and 48% had neuropathic pain. The study also found that gabapentin 900 mg per day for 30 days was effective in decreasing pain intensity and frequency.

 

A multi-site study of 282 patients with MS reporting fatigue between 2013 and 2014 found that 21% of patients reported using prescription opiates, 76% of whom reported regular daily use.

 

Lastly, participants in Spasticity: Take Control—an education and lower extremity stretching program—reported significantly decreased pain severity and interference at 6 months, compared with range-of-motion exercises.

--

Professor and Associate Chief, Department of Neurology, Multiple Sclerosis Division. Perelman School of Medicine at the University of Pennsylvania Philadelphia, Pennsylvania.

Joseph R. Berger, MD, has disclosed the following relevant financial relationships:

Received research grant from: Biogen; Roche/Genentech.

Received income in an amount ≥$250 from: Amgen; Biogen; Bristol Myers Squibb; Celgene; Encycle; Excision BioTherapeutics; Dr. Reddy; Genzyme; Inhibikase Therapeutics; Mapi-Pharma; Merck; Morphic Therapeutic; Novartis; Serono.

Joseph Berger, MD, Associate Chief of the Multiple Sclerosis Division at Perelman School of Medicine at the University of Pennsylvania, presents highlights in multiple sclerosis (MS) symptom management from the ACTRIMS Forum 2021.

 

A follow-up of participants in the self-management program called Fatigue: Take Control found that while patients did not report any significant improvement in fatigue 5-6 years later, they also did not have greater fatigue than at baseline, suggesting that fatigue may not be a progressive symptom.

 

Next, a literature review of efficacy studies in MS rodent models found a complementary pharmacology of CBD and other constituents of nabiximols that may add additional benefit and mitigate THC tolerability.

 

Important pivotal trial results

Watch an overview of our Phase 3 clinical trial data and see why you should make KESIMPTA® (ofatumumab) your 1st choice.

This video is sponsored by Novartis

 

A small study looking at pain prevalence in patients with relapsing-remitting MS (RRMS) found that 76% of patients had a pain syndrome, and 48% had neuropathic pain. The study also found that gabapentin 900 mg per day for 30 days was effective in decreasing pain intensity and frequency.

 

A multi-site study of 282 patients with MS reporting fatigue between 2013 and 2014 found that 21% of patients reported using prescription opiates, 76% of whom reported regular daily use.

 

Lastly, participants in Spasticity: Take Control—an education and lower extremity stretching program—reported significantly decreased pain severity and interference at 6 months, compared with range-of-motion exercises.

--

Professor and Associate Chief, Department of Neurology, Multiple Sclerosis Division. Perelman School of Medicine at the University of Pennsylvania Philadelphia, Pennsylvania.

Joseph R. Berger, MD, has disclosed the following relevant financial relationships:

Received research grant from: Biogen; Roche/Genentech.

Received income in an amount ≥$250 from: Amgen; Biogen; Bristol Myers Squibb; Celgene; Encycle; Excision BioTherapeutics; Dr. Reddy; Genzyme; Inhibikase Therapeutics; Mapi-Pharma; Merck; Morphic Therapeutic; Novartis; Serono.

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Baby born to partially vaccinated mom has COVID-19 antibodies

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Thu, 08/26/2021 - 15:49

 

A baby girl who was born 3 weeks after her mom got the first dose of the Moderna COVID-19 vaccine has antibodies against the coronavirus, according to a preprint paper published on the medRxiv server Feb. 5. The paper hasn’t yet been peer reviewed.

The mom, a health care worker in Florida, developed COVID-19 antibodies after she received the shot. Testing showed that the antibodies passed through the placenta to the baby.

“Maternal vaccination for influenza and TDaP have been well studied in terms of safety and efficacy for protection of the newborn by placental passage of antibodies,” Paul Gilbert, MD, and Chad Rudnick, MD, pediatricians and researchers at Florida Atlantic University, wrote in the paper.

Previous research has indicated that moms who have recovered from COVID-19 can deliver babies with antibodies, according to Insider, but this may be the first report that shows how vaccination during pregnancy can provide antibodies as well.

Dr. Gilbert and Dr. Rudnick said they were fortunate to connect with the mom in Boca Raton. She hadn’t contracted COVID-19 and was able to get the vaccine at the end of her pregnancy in January. When the baby was born, they were able to test the cord blood to look for antibodies specifically from the vaccine.

“We were very excited to see, once the test result came back, that the antibodies from the mom’s vaccine did in fact pass through the placenta to the newborn,” Dr. Rudnick told WPTV, an NBC affiliate in West Palm Beach.

“We knew that we were going to be potentially one of the first in the world to report it, and that opportunity probably only comes once in a career,” Dr. Gilbert told WPTV.

In the preprint, Dr. Gilbert and Dr. Rudnick said a “vigorous, healthy, full-term” baby was born, and the mom received the second dose of the Moderna vaccine during the postpartum period. The newborn received a normal “well-infant” evaluation and was breastfeeding.

The two doctors called for a “significant and urgent need” to research the safety and efficacy of COVID-19 vaccines during pregnancy. They also encouraged other researchers to create pregnancy and breastfeeding registries to study COVID-19 vaccines in pregnant and breastfeeding moms and newborns.

Dr. Gilbert and Dr. Rudnick are now preparing their research for publication and hope future studies will investigate the amount and length of antibody response in newborns.

“Total antibody measurements may be used to determine how long protection is expected, which may help to determine when the best time would be to begin vaccination,” they wrote.

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

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A baby girl who was born 3 weeks after her mom got the first dose of the Moderna COVID-19 vaccine has antibodies against the coronavirus, according to a preprint paper published on the medRxiv server Feb. 5. The paper hasn’t yet been peer reviewed.

The mom, a health care worker in Florida, developed COVID-19 antibodies after she received the shot. Testing showed that the antibodies passed through the placenta to the baby.

“Maternal vaccination for influenza and TDaP have been well studied in terms of safety and efficacy for protection of the newborn by placental passage of antibodies,” Paul Gilbert, MD, and Chad Rudnick, MD, pediatricians and researchers at Florida Atlantic University, wrote in the paper.

Previous research has indicated that moms who have recovered from COVID-19 can deliver babies with antibodies, according to Insider, but this may be the first report that shows how vaccination during pregnancy can provide antibodies as well.

Dr. Gilbert and Dr. Rudnick said they were fortunate to connect with the mom in Boca Raton. She hadn’t contracted COVID-19 and was able to get the vaccine at the end of her pregnancy in January. When the baby was born, they were able to test the cord blood to look for antibodies specifically from the vaccine.

“We were very excited to see, once the test result came back, that the antibodies from the mom’s vaccine did in fact pass through the placenta to the newborn,” Dr. Rudnick told WPTV, an NBC affiliate in West Palm Beach.

“We knew that we were going to be potentially one of the first in the world to report it, and that opportunity probably only comes once in a career,” Dr. Gilbert told WPTV.

In the preprint, Dr. Gilbert and Dr. Rudnick said a “vigorous, healthy, full-term” baby was born, and the mom received the second dose of the Moderna vaccine during the postpartum period. The newborn received a normal “well-infant” evaluation and was breastfeeding.

The two doctors called for a “significant and urgent need” to research the safety and efficacy of COVID-19 vaccines during pregnancy. They also encouraged other researchers to create pregnancy and breastfeeding registries to study COVID-19 vaccines in pregnant and breastfeeding moms and newborns.

Dr. Gilbert and Dr. Rudnick are now preparing their research for publication and hope future studies will investigate the amount and length of antibody response in newborns.

“Total antibody measurements may be used to determine how long protection is expected, which may help to determine when the best time would be to begin vaccination,” they wrote.

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

 

A baby girl who was born 3 weeks after her mom got the first dose of the Moderna COVID-19 vaccine has antibodies against the coronavirus, according to a preprint paper published on the medRxiv server Feb. 5. The paper hasn’t yet been peer reviewed.

The mom, a health care worker in Florida, developed COVID-19 antibodies after she received the shot. Testing showed that the antibodies passed through the placenta to the baby.

“Maternal vaccination for influenza and TDaP have been well studied in terms of safety and efficacy for protection of the newborn by placental passage of antibodies,” Paul Gilbert, MD, and Chad Rudnick, MD, pediatricians and researchers at Florida Atlantic University, wrote in the paper.

Previous research has indicated that moms who have recovered from COVID-19 can deliver babies with antibodies, according to Insider, but this may be the first report that shows how vaccination during pregnancy can provide antibodies as well.

Dr. Gilbert and Dr. Rudnick said they were fortunate to connect with the mom in Boca Raton. She hadn’t contracted COVID-19 and was able to get the vaccine at the end of her pregnancy in January. When the baby was born, they were able to test the cord blood to look for antibodies specifically from the vaccine.

“We were very excited to see, once the test result came back, that the antibodies from the mom’s vaccine did in fact pass through the placenta to the newborn,” Dr. Rudnick told WPTV, an NBC affiliate in West Palm Beach.

“We knew that we were going to be potentially one of the first in the world to report it, and that opportunity probably only comes once in a career,” Dr. Gilbert told WPTV.

In the preprint, Dr. Gilbert and Dr. Rudnick said a “vigorous, healthy, full-term” baby was born, and the mom received the second dose of the Moderna vaccine during the postpartum period. The newborn received a normal “well-infant” evaluation and was breastfeeding.

The two doctors called for a “significant and urgent need” to research the safety and efficacy of COVID-19 vaccines during pregnancy. They also encouraged other researchers to create pregnancy and breastfeeding registries to study COVID-19 vaccines in pregnant and breastfeeding moms and newborns.

Dr. Gilbert and Dr. Rudnick are now preparing their research for publication and hope future studies will investigate the amount and length of antibody response in newborns.

“Total antibody measurements may be used to determine how long protection is expected, which may help to determine when the best time would be to begin vaccination,” they wrote.

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

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