This article last updated 4/8/20. (Disclaimer: The information in this article may not be updated regularly. For more COVID-19 coverage, bookmark our COVID-19 updates page. The editors of The Hospitalist encourage clinicians to also review information on the CDC website and on the AHA  website.) 

An infectious disease outbreak that began in December 2019 in Wuhan (Hubei Province), China, was found to be caused by the seventh strain of coronavirus, initially called the novel (new) coronavirus. The virus was later labeled as severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). The disease caused by SARS-CoV-2 is named COVID-19. Until 2019, only six strains of human coronaviruses had previously been identified.

Courtesy NIAID-RML

As of April 8, 2020, according to the U.S. Centers for Disease Control and Prevention, COVID-19 has been detected in at least 209 countries and has spread to every contintent except Antarctica. More than 1,469,245 people have become infected globally, and at least 86,278 have died. Based on the cases detected and tested in the United States through the U.S. public health surveillance systems, we have had 406,693 confirmed cases and 13,089 deaths.

On March 11, 2020, the World Health Organization formally declared the COVID-19 outbreak to be a pandemic.

As the number of cases increases in the United States, we hope to provide answers about some common questions regarding COVID-19. The information summarized in this article is obtained and modified from the CDC.

What are the clinical features of COVID-19?

Ranges from asymptomatic infection, a mild disease with nonspecific signs and symptoms of acute respiratory illness, to severe pneumonia with respiratory failure and septic shock.

Who is at risk for COVID-19?

Persons who have had prolonged, unprotected close contact with a patient with symptomatic, confirmed COVID-19, and those with recent travel to China, especially Hubei Province.

Who is at risk for severe disease from COVID-19?

Older adults and persons who have underlying chronic medical conditions, such as immunocompromising conditions.

How is COVID-19 spread?

Person-to-person, mainly through respiratory droplets. SARS-CoV-2 has been isolated from upper respiratory tract specimens and bronchoalveolar lavage fluid.

When is someone infectious?

Incubation period may range from 2 to 14 days. Detection of viral RNA does not necessarily mean that infectious virus is present, as it may be detectable in the upper or lower respiratory tract for weeks after illness onset.

Can someone who has been quarantined for COVID-19 spread the illness to others?

For COVID-19, the period of quarantine is 14 days from the last date of exposure, because 14 days is the longest incubation period seen for similar coronaviruses. Someone who has been released from COVID-19 quarantine is not considered a risk for spreading the virus to others because they have not developed illness during the incubation period.

Can a person test negative and later test positive for COVID-19?

Yes. In the early stages of infection, it is possible the virus will not be detected.

Do patients with confirmed or suspected COVID-19 need to be admitted to the hospital?

Not all patients with COVID-19 require hospital admission. Patients whose clinical presentation warrants inpatient clinical management for supportive medical care should be admitted to the hospital under appropriate isolation precautions. The decision to monitor these patients in the inpatient or outpatient setting should be made on a case-by-case basis.

What should you do if you suspect a patient for COVID-19?

Immediately notify both infection control personnel at your health care facility and your local or state health department. State health departments that have identified a person under investigation (PUI) should immediately contact CDC’s Emergency Operations Center (EOC) at 770-488-7100 and complete a COVID-19 PUI case investigation form.

CDC’s EOC will assist local/state health departments to collect, store, and ship specimens appropriately to CDC, including during after-hours or on weekends/holidays.
 

What type of isolation is needed for COVID-19?

Airborne Infection Isolation Room (AIIR) using Standard, Contact, and Airborne Precautions with eye protection.

How should health care personnel protect themselves when evaluating a patient who may have COVID-19?

Standard Precautions, Contact Precautions, Airborne Precautions, and use eye protection (e.g., goggles or a face shield).

What face mask do health care workers wear for respiratory protection?

A fit-tested NIOSH-certified disposable N95 filtering facepiece respirator should be worn before entry into the patient room or care area. Disposable respirators should be removed and discarded after exiting the patient’s room or care area and closing the door. Perform hand hygiene after discarding the respirator.

If reusable respirators (e.g., powered air purifying respirator/PAPR) are used, they must be cleaned and disinfected according to manufacturer’s reprocessing instructions prior to re-use.
 

What should you tell the patient if COVID-19 is suspected or confirmed?

Patients with suspected or confirmed COVID-19 should be asked to wear a surgical mask as soon as they are identified, to prevent spread to others.

Should any diagnostic or therapeutic interventions be withheld because of concerns about the transmission of COVID-19?

No.

How do you test a patient for SARS-CoV-2, the virus that causes COVID-19?

At this time, diagnostic testing for COVID-19 can be conducted only at CDC.

The CDC recommends collecting and testing multiple clinical specimens from different sites, including two specimen types – lower respiratory and upper respiratory (nasopharyngeal and oropharyngeal aspirates or washes, nasopharyngeal and oropharyngeal swabs, bronchioalveolar lavage, tracheal aspirates, sputum, and serum) using a real-time reverse transcription PCR (rRT-PCR) assay for SARS-CoV-2. Specimens should be collected as soon as possible once a PUI is identified regardless of the time of symptom onset. Turnaround time for the PCR assay testing is about 24-48 hours.

Will existing respiratory virus panels detect SARS-CoV-2, the virus that causes COVID-19?

No.

How is COVID-19 treated?

Symptomatic management. Corticosteroids are not routinely recommended for viral pneumonia or acute respiratory distress syndrome and should be avoided unless they are indicated for another reason (e.g., COPD exacerbation, refractory septic shock following Surviving Sepsis Campaign Guidelines). There are currently no antiviral drugs licensed by the U.S. Food and Drug Administration to treat COVID-19.
 

What is considered ‘close contact’ for health care exposures?

Being within approximately 6 feet (2 meters), of a person with COVID-19 for a prolonged period of time (such as caring for or visiting the patient, or sitting within 6 feet of the patient in a health care waiting area or room); or having unprotected direct contact with infectious secretions or excretions of the patient (e.g., being coughed on, touching used tissues with a bare hand). However, until more is known about transmission risks, it would be reasonable to consider anything longer than a brief (e.g., less than 1-2 minutes) exposure as prolonged.

What happens if the health care personnel (HCP) are exposed to confirmed COVID-19 patients? What’s the protocol for HCP exposed to persons under investigation (PUI) if test results are delayed beyond 48-72 hours?

Management is similar in both these scenarios. CDC categorized exposures as high, medium, low, and no identifiable risk. High- and medium-risk exposures are managed similarly with active monitoring for COVID-19 until 14 days after last potential exposure and exclude from work for 14 days after last exposure. Active monitoring means that the state or local public health authority assumes responsibility for establishing regular communication with potentially exposed people to assess for the presence of fever or respiratory symptoms (e.g., cough, shortness of breath, sore throat). For HCP with high- or medium-risk exposures, CDC recommends this communication occurs at least once each day. For full details, please see www.cdc.gov/coronavirus/2019-ncov/hcp/guidance-risk-assesment-hcp.html.

Should postexposure prophylaxis be used for people who may have been exposed to COVID-19?

None available.

COVID-19 test results are negative in a symptomatic patient you suspected of COVID-19? What does it mean?

A negative test result for a sample collected while a person has symptoms likely means that the COVID-19 virus is not causing their current illness.

What if your hospital does not have an Airborne Infection Isolation Room (AIIR) for COVID-19 patients?

Transfer the patient to a facility that has an available AIIR. If a transfer is impractical or not medically appropriate, the patient should be cared for in a single-person room and the door should be kept closed. The room should ideally not have an exhaust that is recirculated within the building without high-efficiency particulate air (HEPA) filtration. Health care personnel should still use gloves, gown, respiratory and eye protection and follow all other recommended infection prevention and control practices when caring for these patients.
 

What if your hospital does not have enough Airborne Infection Isolation Rooms (AIIR) for COVID-19 patients?

Prioritize patients for AIIR who are symptomatic with severe illness (e.g., those requiring ventilator support).

When can patients with confirmed COVID-19 be discharged from the hospital?

Patients can be discharged from the health care facility whenever clinically indicated. Isolation should be maintained at home if the patient returns home before the time period recommended for discontinuation of hospital transmission-based precautions.

Considerations to discontinue transmission-based precautions include all of the following:

• Resolution of fever, without the use of antipyretic medication.
• Improvement in illness signs and symptoms.
• Negative rRT-PCR results from at least two consecutive sets of paired nasopharyngeal and throat swabs specimens collected at least 24 hours apart (total of four negative specimens – two nasopharyngeal and two throat) from a patient with COVID-19 are needed before discontinuing transmission-based precautions.

Should people be concerned about pets or other animals and COVID-19?

To date, CDC has not received any reports of pets or other animals becoming sick with COVID-19.

Should patients avoid contact with pets or other animals if they are sick with COVID-19?

Patients should restrict contact with pets and other animals while they are sick with COVID-19, just like they would around other people.

Does CDC recommend the use of face masks in the community to prevent COVID-19?

CDC does not recommend that people who are well wear a face mask to protect themselves from respiratory illnesses, including COVID-19. A face mask should be used by people who have COVID-19 and are showing symptoms to protect others from the risk of getting infected.

Should medical waste or general waste from health care facilities treating PUIs and patients with confirmed COVID-19 be handled any differently or need any additional disinfection?

No. CDC’s guidance states that management of laundry, food service utensils, and medical waste should be performed in accordance with routine procedures.

Can people who recover from COVID-19 be infected again?

Unknown. The immune response to COVID-19 is not yet understood.

What is the mortality rate of COVID-19, and how does it compare to the mortality rate of influenza (flu)?

The average 10-year mortality rate for flu, using CDC data, is found to be around 0.1%. Even though this percentage appears to be small, influenza is estimated to be responsible for 30,000 to 40,000 deaths annually in the U.S.

According to statistics released by the Chinese Center for Disease Control and Prevention on Feb. 17, the mortality rate of COVID-19 is estimated to be around 2.3%. This calculation was based on cases reported through Feb. 11, and calcuated by dividing the number of coronavirus-related deaths at the time (1,023) by the number of confirmed cases (44,672) of COVID-19 infection. However, this report has its limitations, since Chinese officials have a vague way of defining who has COVID-19 infection.

The World Health Organization (WHO) currently estimates the mortality rate for COVID-19 to be between 2% and 4%.

Dr. Sitammagari is a co-medical director for quality and assistant professor of internal medicine at Atrium Health, Charlotte, N.C. He is also a physician advisor. He currently serves as treasurer for the NC-Triangle Chapter of the Society of Hospital Medicine and as an editorial board member of The Hospitalist.

Dr. Skandhan is a hospitalist and member of the Core Faculty for the Internal Medicine Residency Program at Southeast Health (SEH), Dothan Ala., and an assistant professor at the Alabama College of Osteopathic Medicine. He serves as the medical director/physician liaison for the Clinical Documentation Program at SEH and also as the director for physician integration for Southeast Health Statera Network, an Accountable Care Organization. Dr. Skandhan was a cofounder of the Wiregrass chapter of SHM and currently serves on the Advisory board. He is also a member of the editorial board of The Hospitalist.

Dr. Dahlin is a second-year internal medicine resident at Southeast Health, Dothan, Ala. She serves as her class representative and is the cochair/resident liaison for the research committee at SEH. Dr. Dahlin also serves as a resident liaison for the Wiregrass chapter of SHM.

This article last updated 4/8/20. (Disclaimer: The information in this article may not be updated regularly. For more COVID-19 coverage, bookmark our COVID-19 updates page. The editors of The Hospitalist encourage clinicians to also review information on the CDC website and on the AHA  website.) 

An infectious disease outbreak that began in December 2019 in Wuhan (Hubei Province), China, was found to be caused by the seventh strain of coronavirus, initially called the novel (new) coronavirus. The virus was later labeled as severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). The disease caused by SARS-CoV-2 is named COVID-19. Until 2019, only six strains of human coronaviruses had previously been identified.

Courtesy NIAID-RML

As of April 8, 2020, according to the U.S. Centers for Disease Control and Prevention, COVID-19 has been detected in at least 209 countries and has spread to every contintent except Antarctica. More than 1,469,245 people have become infected globally, and at least 86,278 have died. Based on the cases detected and tested in the United States through the U.S. public health surveillance systems, we have had 406,693 confirmed cases and 13,089 deaths.

On March 11, 2020, the World Health Organization formally declared the COVID-19 outbreak to be a pandemic.

As the number of cases increases in the United States, we hope to provide answers about some common questions regarding COVID-19. The information summarized in this article is obtained and modified from the CDC.

What are the clinical features of COVID-19?

Ranges from asymptomatic infection, a mild disease with nonspecific signs and symptoms of acute respiratory illness, to severe pneumonia with respiratory failure and septic shock.

Who is at risk for COVID-19?

Persons who have had prolonged, unprotected close contact with a patient with symptomatic, confirmed COVID-19, and those with recent travel to China, especially Hubei Province.

Who is at risk for severe disease from COVID-19?

Older adults and persons who have underlying chronic medical conditions, such as immunocompromising conditions.

How is COVID-19 spread?

Person-to-person, mainly through respiratory droplets. SARS-CoV-2 has been isolated from upper respiratory tract specimens and bronchoalveolar lavage fluid.

When is someone infectious?

Incubation period may range from 2 to 14 days. Detection of viral RNA does not necessarily mean that infectious virus is present, as it may be detectable in the upper or lower respiratory tract for weeks after illness onset.

Can someone who has been quarantined for COVID-19 spread the illness to others?

For COVID-19, the period of quarantine is 14 days from the last date of exposure, because 14 days is the longest incubation period seen for similar coronaviruses. Someone who has been released from COVID-19 quarantine is not considered a risk for spreading the virus to others because they have not developed illness during the incubation period.

Can a person test negative and later test positive for COVID-19?

Yes. In the early stages of infection, it is possible the virus will not be detected.

Do patients with confirmed or suspected COVID-19 need to be admitted to the hospital?

Not all patients with COVID-19 require hospital admission. Patients whose clinical presentation warrants inpatient clinical management for supportive medical care should be admitted to the hospital under appropriate isolation precautions. The decision to monitor these patients in the inpatient or outpatient setting should be made on a case-by-case basis.

What should you do if you suspect a patient for COVID-19?

Immediately notify both infection control personnel at your health care facility and your local or state health department. State health departments that have identified a person under investigation (PUI) should immediately contact CDC’s Emergency Operations Center (EOC) at 770-488-7100 and complete a COVID-19 PUI case investigation form.

CDC’s EOC will assist local/state health departments to collect, store, and ship specimens appropriately to CDC, including during after-hours or on weekends/holidays.
 

What type of isolation is needed for COVID-19?

Airborne Infection Isolation Room (AIIR) using Standard, Contact, and Airborne Precautions with eye protection.

How should health care personnel protect themselves when evaluating a patient who may have COVID-19?

Standard Precautions, Contact Precautions, Airborne Precautions, and use eye protection (e.g., goggles or a face shield).

What face mask do health care workers wear for respiratory protection?

A fit-tested NIOSH-certified disposable N95 filtering facepiece respirator should be worn before entry into the patient room or care area. Disposable respirators should be removed and discarded after exiting the patient’s room or care area and closing the door. Perform hand hygiene after discarding the respirator.

If reusable respirators (e.g., powered air purifying respirator/PAPR) are used, they must be cleaned and disinfected according to manufacturer’s reprocessing instructions prior to re-use.
 

What should you tell the patient if COVID-19 is suspected or confirmed?

Patients with suspected or confirmed COVID-19 should be asked to wear a surgical mask as soon as they are identified, to prevent spread to others.

Should any diagnostic or therapeutic interventions be withheld because of concerns about the transmission of COVID-19?

No.

How do you test a patient for SARS-CoV-2, the virus that causes COVID-19?

At this time, diagnostic testing for COVID-19 can be conducted only at CDC.

The CDC recommends collecting and testing multiple clinical specimens from different sites, including two specimen types – lower respiratory and upper respiratory (nasopharyngeal and oropharyngeal aspirates or washes, nasopharyngeal and oropharyngeal swabs, bronchioalveolar lavage, tracheal aspirates, sputum, and serum) using a real-time reverse transcription PCR (rRT-PCR) assay for SARS-CoV-2. Specimens should be collected as soon as possible once a PUI is identified regardless of the time of symptom onset. Turnaround time for the PCR assay testing is about 24-48 hours.

Will existing respiratory virus panels detect SARS-CoV-2, the virus that causes COVID-19?

No.

How is COVID-19 treated?

Symptomatic management. Corticosteroids are not routinely recommended for viral pneumonia or acute respiratory distress syndrome and should be avoided unless they are indicated for another reason (e.g., COPD exacerbation, refractory septic shock following Surviving Sepsis Campaign Guidelines). There are currently no antiviral drugs licensed by the U.S. Food and Drug Administration to treat COVID-19.
 

What is considered ‘close contact’ for health care exposures?

Being within approximately 6 feet (2 meters), of a person with COVID-19 for a prolonged period of time (such as caring for or visiting the patient, or sitting within 6 feet of the patient in a health care waiting area or room); or having unprotected direct contact with infectious secretions or excretions of the patient (e.g., being coughed on, touching used tissues with a bare hand). However, until more is known about transmission risks, it would be reasonable to consider anything longer than a brief (e.g., less than 1-2 minutes) exposure as prolonged.

What happens if the health care personnel (HCP) are exposed to confirmed COVID-19 patients? What’s the protocol for HCP exposed to persons under investigation (PUI) if test results are delayed beyond 48-72 hours?

Management is similar in both these scenarios. CDC categorized exposures as high, medium, low, and no identifiable risk. High- and medium-risk exposures are managed similarly with active monitoring for COVID-19 until 14 days after last potential exposure and exclude from work for 14 days after last exposure. Active monitoring means that the state or local public health authority assumes responsibility for establishing regular communication with potentially exposed people to assess for the presence of fever or respiratory symptoms (e.g., cough, shortness of breath, sore throat). For HCP with high- or medium-risk exposures, CDC recommends this communication occurs at least once each day. For full details, please see www.cdc.gov/coronavirus/2019-ncov/hcp/guidance-risk-assesment-hcp.html.

Should postexposure prophylaxis be used for people who may have been exposed to COVID-19?

None available.

COVID-19 test results are negative in a symptomatic patient you suspected of COVID-19? What does it mean?

A negative test result for a sample collected while a person has symptoms likely means that the COVID-19 virus is not causing their current illness.

What if your hospital does not have an Airborne Infection Isolation Room (AIIR) for COVID-19 patients?

Transfer the patient to a facility that has an available AIIR. If a transfer is impractical or not medically appropriate, the patient should be cared for in a single-person room and the door should be kept closed. The room should ideally not have an exhaust that is recirculated within the building without high-efficiency particulate air (HEPA) filtration. Health care personnel should still use gloves, gown, respiratory and eye protection and follow all other recommended infection prevention and control practices when caring for these patients.
 

What if your hospital does not have enough Airborne Infection Isolation Rooms (AIIR) for COVID-19 patients?

Prioritize patients for AIIR who are symptomatic with severe illness (e.g., those requiring ventilator support).

When can patients with confirmed COVID-19 be discharged from the hospital?

Patients can be discharged from the health care facility whenever clinically indicated. Isolation should be maintained at home if the patient returns home before the time period recommended for discontinuation of hospital transmission-based precautions.

Considerations to discontinue transmission-based precautions include all of the following:

• Resolution of fever, without the use of antipyretic medication.
• Improvement in illness signs and symptoms.
• Negative rRT-PCR results from at least two consecutive sets of paired nasopharyngeal and throat swabs specimens collected at least 24 hours apart (total of four negative specimens – two nasopharyngeal and two throat) from a patient with COVID-19 are needed before discontinuing transmission-based precautions.

Should people be concerned about pets or other animals and COVID-19?

To date, CDC has not received any reports of pets or other animals becoming sick with COVID-19.

Should patients avoid contact with pets or other animals if they are sick with COVID-19?

Patients should restrict contact with pets and other animals while they are sick with COVID-19, just like they would around other people.

Does CDC recommend the use of face masks in the community to prevent COVID-19?

CDC does not recommend that people who are well wear a face mask to protect themselves from respiratory illnesses, including COVID-19. A face mask should be used by people who have COVID-19 and are showing symptoms to protect others from the risk of getting infected.

Should medical waste or general waste from health care facilities treating PUIs and patients with confirmed COVID-19 be handled any differently or need any additional disinfection?

No. CDC’s guidance states that management of laundry, food service utensils, and medical waste should be performed in accordance with routine procedures.

Can people who recover from COVID-19 be infected again?

Unknown. The immune response to COVID-19 is not yet understood.

What is the mortality rate of COVID-19, and how does it compare to the mortality rate of influenza (flu)?

The average 10-year mortality rate for flu, using CDC data, is found to be around 0.1%. Even though this percentage appears to be small, influenza is estimated to be responsible for 30,000 to 40,000 deaths annually in the U.S.

According to statistics released by the Chinese Center for Disease Control and Prevention on Feb. 17, the mortality rate of COVID-19 is estimated to be around 2.3%. This calculation was based on cases reported through Feb. 11, and calcuated by dividing the number of coronavirus-related deaths at the time (1,023) by the number of confirmed cases (44,672) of COVID-19 infection. However, this report has its limitations, since Chinese officials have a vague way of defining who has COVID-19 infection.

The World Health Organization (WHO) currently estimates the mortality rate for COVID-19 to be between 2% and 4%.

Dr. Sitammagari is a co-medical director for quality and assistant professor of internal medicine at Atrium Health, Charlotte, N.C. He is also a physician advisor. He currently serves as treasurer for the NC-Triangle Chapter of the Society of Hospital Medicine and as an editorial board member of The Hospitalist.

Dr. Skandhan is a hospitalist and member of the Core Faculty for the Internal Medicine Residency Program at Southeast Health (SEH), Dothan Ala., and an assistant professor at the Alabama College of Osteopathic Medicine. He serves as the medical director/physician liaison for the Clinical Documentation Program at SEH and also as the director for physician integration for Southeast Health Statera Network, an Accountable Care Organization. Dr. Skandhan was a cofounder of the Wiregrass chapter of SHM and currently serves on the Advisory board. He is also a member of the editorial board of The Hospitalist.

Dr. Dahlin is a second-year internal medicine resident at Southeast Health, Dothan, Ala. She serves as her class representative and is the cochair/resident liaison for the research committee at SEH. Dr. Dahlin also serves as a resident liaison for the Wiregrass chapter of SHM.

This article last updated 4/8/20. (Disclaimer: The information in this article may not be updated regularly. For more COVID-19 coverage, bookmark our COVID-19 updates page. The editors of The Hospitalist encourage clinicians to also review information on the CDC website and on the AHA  website.) 

An infectious disease outbreak that began in December 2019 in Wuhan (Hubei Province), China, was found to be caused by the seventh strain of coronavirus, initially called the novel (new) coronavirus. The virus was later labeled as severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). The disease caused by SARS-CoV-2 is named COVID-19. Until 2019, only six strains of human coronaviruses had previously been identified.

Courtesy NIAID-RML

As of April 8, 2020, according to the U.S. Centers for Disease Control and Prevention, COVID-19 has been detected in at least 209 countries and has spread to every contintent except Antarctica. More than 1,469,245 people have become infected globally, and at least 86,278 have died. Based on the cases detected and tested in the United States through the U.S. public health surveillance systems, we have had 406,693 confirmed cases and 13,089 deaths.

On March 11, 2020, the World Health Organization formally declared the COVID-19 outbreak to be a pandemic.

As the number of cases increases in the United States, we hope to provide answers about some common questions regarding COVID-19. The information summarized in this article is obtained and modified from the CDC.

What are the clinical features of COVID-19?

Ranges from asymptomatic infection, a mild disease with nonspecific signs and symptoms of acute respiratory illness, to severe pneumonia with respiratory failure and septic shock.

Who is at risk for COVID-19?

Persons who have had prolonged, unprotected close contact with a patient with symptomatic, confirmed COVID-19, and those with recent travel to China, especially Hubei Province.

Who is at risk for severe disease from COVID-19?

Older adults and persons who have underlying chronic medical conditions, such as immunocompromising conditions.

How is COVID-19 spread?

Person-to-person, mainly through respiratory droplets. SARS-CoV-2 has been isolated from upper respiratory tract specimens and bronchoalveolar lavage fluid.

When is someone infectious?

Incubation period may range from 2 to 14 days. Detection of viral RNA does not necessarily mean that infectious virus is present, as it may be detectable in the upper or lower respiratory tract for weeks after illness onset.

Can someone who has been quarantined for COVID-19 spread the illness to others?

For COVID-19, the period of quarantine is 14 days from the last date of exposure, because 14 days is the longest incubation period seen for similar coronaviruses. Someone who has been released from COVID-19 quarantine is not considered a risk for spreading the virus to others because they have not developed illness during the incubation period.

Can a person test negative and later test positive for COVID-19?

Yes. In the early stages of infection, it is possible the virus will not be detected.

Do patients with confirmed or suspected COVID-19 need to be admitted to the hospital?

Not all patients with COVID-19 require hospital admission. Patients whose clinical presentation warrants inpatient clinical management for supportive medical care should be admitted to the hospital under appropriate isolation precautions. The decision to monitor these patients in the inpatient or outpatient setting should be made on a case-by-case basis.

What should you do if you suspect a patient for COVID-19?

Immediately notify both infection control personnel at your health care facility and your local or state health department. State health departments that have identified a person under investigation (PUI) should immediately contact CDC’s Emergency Operations Center (EOC) at 770-488-7100 and complete a COVID-19 PUI case investigation form.

CDC’s EOC will assist local/state health departments to collect, store, and ship specimens appropriately to CDC, including during after-hours or on weekends/holidays.
 

What type of isolation is needed for COVID-19?

Airborne Infection Isolation Room (AIIR) using Standard, Contact, and Airborne Precautions with eye protection.

How should health care personnel protect themselves when evaluating a patient who may have COVID-19?

Standard Precautions, Contact Precautions, Airborne Precautions, and use eye protection (e.g., goggles or a face shield).

What face mask do health care workers wear for respiratory protection?

A fit-tested NIOSH-certified disposable N95 filtering facepiece respirator should be worn before entry into the patient room or care area. Disposable respirators should be removed and discarded after exiting the patient’s room or care area and closing the door. Perform hand hygiene after discarding the respirator.

If reusable respirators (e.g., powered air purifying respirator/PAPR) are used, they must be cleaned and disinfected according to manufacturer’s reprocessing instructions prior to re-use.
 

What should you tell the patient if COVID-19 is suspected or confirmed?

Patients with suspected or confirmed COVID-19 should be asked to wear a surgical mask as soon as they are identified, to prevent spread to others.

Should any diagnostic or therapeutic interventions be withheld because of concerns about the transmission of COVID-19?

No.

How do you test a patient for SARS-CoV-2, the virus that causes COVID-19?

At this time, diagnostic testing for COVID-19 can be conducted only at CDC.

The CDC recommends collecting and testing multiple clinical specimens from different sites, including two specimen types – lower respiratory and upper respiratory (nasopharyngeal and oropharyngeal aspirates or washes, nasopharyngeal and oropharyngeal swabs, bronchioalveolar lavage, tracheal aspirates, sputum, and serum) using a real-time reverse transcription PCR (rRT-PCR) assay for SARS-CoV-2. Specimens should be collected as soon as possible once a PUI is identified regardless of the time of symptom onset. Turnaround time for the PCR assay testing is about 24-48 hours.

Will existing respiratory virus panels detect SARS-CoV-2, the virus that causes COVID-19?

No.

How is COVID-19 treated?

Symptomatic management. Corticosteroids are not routinely recommended for viral pneumonia or acute respiratory distress syndrome and should be avoided unless they are indicated for another reason (e.g., COPD exacerbation, refractory septic shock following Surviving Sepsis Campaign Guidelines). There are currently no antiviral drugs licensed by the U.S. Food and Drug Administration to treat COVID-19.
 

What is considered ‘close contact’ for health care exposures?

Being within approximately 6 feet (2 meters), of a person with COVID-19 for a prolonged period of time (such as caring for or visiting the patient, or sitting within 6 feet of the patient in a health care waiting area or room); or having unprotected direct contact with infectious secretions or excretions of the patient (e.g., being coughed on, touching used tissues with a bare hand). However, until more is known about transmission risks, it would be reasonable to consider anything longer than a brief (e.g., less than 1-2 minutes) exposure as prolonged.

What happens if the health care personnel (HCP) are exposed to confirmed COVID-19 patients? What’s the protocol for HCP exposed to persons under investigation (PUI) if test results are delayed beyond 48-72 hours?

Management is similar in both these scenarios. CDC categorized exposures as high, medium, low, and no identifiable risk. High- and medium-risk exposures are managed similarly with active monitoring for COVID-19 until 14 days after last potential exposure and exclude from work for 14 days after last exposure. Active monitoring means that the state or local public health authority assumes responsibility for establishing regular communication with potentially exposed people to assess for the presence of fever or respiratory symptoms (e.g., cough, shortness of breath, sore throat). For HCP with high- or medium-risk exposures, CDC recommends this communication occurs at least once each day. For full details, please see www.cdc.gov/coronavirus/2019-ncov/hcp/guidance-risk-assesment-hcp.html.

Should postexposure prophylaxis be used for people who may have been exposed to COVID-19?

None available.

COVID-19 test results are negative in a symptomatic patient you suspected of COVID-19? What does it mean?

A negative test result for a sample collected while a person has symptoms likely means that the COVID-19 virus is not causing their current illness.

What if your hospital does not have an Airborne Infection Isolation Room (AIIR) for COVID-19 patients?

Transfer the patient to a facility that has an available AIIR. If a transfer is impractical or not medically appropriate, the patient should be cared for in a single-person room and the door should be kept closed. The room should ideally not have an exhaust that is recirculated within the building without high-efficiency particulate air (HEPA) filtration. Health care personnel should still use gloves, gown, respiratory and eye protection and follow all other recommended infection prevention and control practices when caring for these patients.
 

What if your hospital does not have enough Airborne Infection Isolation Rooms (AIIR) for COVID-19 patients?

Prioritize patients for AIIR who are symptomatic with severe illness (e.g., those requiring ventilator support).

When can patients with confirmed COVID-19 be discharged from the hospital?

Patients can be discharged from the health care facility whenever clinically indicated. Isolation should be maintained at home if the patient returns home before the time period recommended for discontinuation of hospital transmission-based precautions.

Considerations to discontinue transmission-based precautions include all of the following:

• Resolution of fever, without the use of antipyretic medication.
• Improvement in illness signs and symptoms.
• Negative rRT-PCR results from at least two consecutive sets of paired nasopharyngeal and throat swabs specimens collected at least 24 hours apart (total of four negative specimens – two nasopharyngeal and two throat) from a patient with COVID-19 are needed before discontinuing transmission-based precautions.

Should people be concerned about pets or other animals and COVID-19?

To date, CDC has not received any reports of pets or other animals becoming sick with COVID-19.

Should patients avoid contact with pets or other animals if they are sick with COVID-19?

Patients should restrict contact with pets and other animals while they are sick with COVID-19, just like they would around other people.

Does CDC recommend the use of face masks in the community to prevent COVID-19?

CDC does not recommend that people who are well wear a face mask to protect themselves from respiratory illnesses, including COVID-19. A face mask should be used by people who have COVID-19 and are showing symptoms to protect others from the risk of getting infected.

Should medical waste or general waste from health care facilities treating PUIs and patients with confirmed COVID-19 be handled any differently or need any additional disinfection?

No. CDC’s guidance states that management of laundry, food service utensils, and medical waste should be performed in accordance with routine procedures.

Can people who recover from COVID-19 be infected again?

Unknown. The immune response to COVID-19 is not yet understood.

What is the mortality rate of COVID-19, and how does it compare to the mortality rate of influenza (flu)?

The average 10-year mortality rate for flu, using CDC data, is found to be around 0.1%. Even though this percentage appears to be small, influenza is estimated to be responsible for 30,000 to 40,000 deaths annually in the U.S.

According to statistics released by the Chinese Center for Disease Control and Prevention on Feb. 17, the mortality rate of COVID-19 is estimated to be around 2.3%. This calculation was based on cases reported through Feb. 11, and calcuated by dividing the number of coronavirus-related deaths at the time (1,023) by the number of confirmed cases (44,672) of COVID-19 infection. However, this report has its limitations, since Chinese officials have a vague way of defining who has COVID-19 infection.

The World Health Organization (WHO) currently estimates the mortality rate for COVID-19 to be between 2% and 4%.

Dr. Sitammagari is a co-medical director for quality and assistant professor of internal medicine at Atrium Health, Charlotte, N.C. He is also a physician advisor. He currently serves as treasurer for the NC-Triangle Chapter of the Society of Hospital Medicine and as an editorial board member of The Hospitalist.

Dr. Skandhan is a hospitalist and member of the Core Faculty for the Internal Medicine Residency Program at Southeast Health (SEH), Dothan Ala., and an assistant professor at the Alabama College of Osteopathic Medicine. He serves as the medical director/physician liaison for the Clinical Documentation Program at SEH and also as the director for physician integration for Southeast Health Statera Network, an Accountable Care Organization. Dr. Skandhan was a cofounder of the Wiregrass chapter of SHM and currently serves on the Advisory board. He is also a member of the editorial board of The Hospitalist.

Dr. Dahlin is a second-year internal medicine resident at Southeast Health, Dothan, Ala. She serves as her class representative and is the cochair/resident liaison for the research committee at SEH. Dr. Dahlin also serves as a resident liaison for the Wiregrass chapter of SHM.

WEST PALM BEACH, FLA. – Among patients with relapsing multiple sclerosis (MS) and visual impairment who received a potential remyelinating treatment or placebo for as long as 36 weeks, median low-contrast letter acuity improved in the population overall, according to an interim, blinded analysis. Exploratory outcome measures of cognition, gait, and upper extremity function also improved.

Jake Remaly/MDedge News

The results do not mean that the treatment works. “We know that placebo works. I’m not here to tell you that the drug works. I’m just here to tell you that we have intriguing data,” said Robert Glanzman, MD, chief medical officer of Clene Nanomedicine, the developer of the drug.

The patients in the interim analysis represent about 25% of the target study population of 150 patients, Dr. Glanzman said. The phase 2, double-blind, randomized, controlled trial, VISIONARY-MS, is assessing the efficacy and safety of CNM-Au8, a suspension of clean-surfaced gold nanocrystals that may support intracellular biologic processes. Patients are randomly assigned to receive low-dose CNM-Au8, high-dose CNM-Au8, or placebo taken orally once daily.

Neuroprotective or remyelinating agents are an unmet need in MS, Dr. Glanzman said. VISIONARY-MS has enrolled patients at centers in Australia and recently expanded the trial sites in North America. Dr. Glanzman presented the interim data during a joint symposium of the North American Imaging in MS Cooperative and the International Multiple Sclerosis Visual System Consortium at the meeting held by the Americas Committee for Treatment and Research in Multiple Sclerosis.

VISIONARY-MS is enrolling participants with chronic optic neuropathy, defined as visual impairment with no episodes of acute optic neuritis within the 6 months prior to enrollment, and nonactive disease, defined as no MS relapses within the prior 3 months. Patients may take concomitant immunomodulatory disease-modifying MS therapies during the trial.

The primary endpoint is improvement in low-contrast letter acuity (LCLA) from baseline to week 24. Secondary endpoints are change in amplitude and latency of multifocal visual evoked potential. Other functional measures are exploratory endpoints. Participants remain in the trial through week 48 or until the last participant completes week 24.

Among the first 34 enrolled participants, median LCLA improved by about five letters, Dr. Glanzman said. Patients also had median improvement on other subscales of the modified Multiple Sclerosis Functional Composite (MSFC) that assess cognition (Symbol Digit Modalities Test), upper extremity function (9-Hole Peg Test), and gait (Timed 25-foot Walk). CNM-Au8 has been well tolerated, and no serious adverse events related to the study drug have been reported. The most frequent adverse events include headache, upper respiratory infection, and sore throat. Full unblinded results are anticipated in 2021.

About 60% of patients in the interim analysis were female, and the mean Expanded Disability Status Scale score was less than 2, Dr. Glanzman said.

“These data add to the growing body of clinical evidence demonstrating that CNM-Au8, a suspension of catalytic, clean-surfaced, faceted gold nanocrystals, has the unique ability to improve remyelination and provide axonal neuroprotection,” Dr. Glanzman said in a news release. “The consistent median improvements observed across the MSFC functional domains in the population of participants in VISIONARY-MS are exciting.”

At previous meetings, research has described data from studies that have provided evidence of efficacy in animal models of MS. An overview of the preclinical studies – “Nanocatalytic activity of clean-surfaced, faceted nanocrystalline gold enhances remyelination in animal models of multiple sclerosis” – was published recently in Scientific Reports (2020 Feb 11;10[1]:1936). Preclinical studies in animal models of diseases other than MS also have shown evidence of neuroprotection, Dr. Glanzman said.

“We are studying the visual system in order to interrogate the nervous system as a whole,” he said. “The visual system is by far the most sensitive to change.” The design of VISIONARY-MS was informed by a trial of clemastine fumarate as a potential remyelinating agent in patients with chronic optic neuropathy, Dr. Glanzman added.

Dr. Glanzman is an employee of Clene Nanomedicine, and receives salary and stock options.

jremaly@mdedge.com

SOURCE: Glanzman R. ACTRIMS Forum 2020, Abstract.

WEST PALM BEACH, FLA. – Among patients with relapsing multiple sclerosis (MS) and visual impairment who received a potential remyelinating treatment or placebo for as long as 36 weeks, median low-contrast letter acuity improved in the population overall, according to an interim, blinded analysis. Exploratory outcome measures of cognition, gait, and upper extremity function also improved.

Jake Remaly/MDedge News

The results do not mean that the treatment works. “We know that placebo works. I’m not here to tell you that the drug works. I’m just here to tell you that we have intriguing data,” said Robert Glanzman, MD, chief medical officer of Clene Nanomedicine, the developer of the drug.

The patients in the interim analysis represent about 25% of the target study population of 150 patients, Dr. Glanzman said. The phase 2, double-blind, randomized, controlled trial, VISIONARY-MS, is assessing the efficacy and safety of CNM-Au8, a suspension of clean-surfaced gold nanocrystals that may support intracellular biologic processes. Patients are randomly assigned to receive low-dose CNM-Au8, high-dose CNM-Au8, or placebo taken orally once daily.

Neuroprotective or remyelinating agents are an unmet need in MS, Dr. Glanzman said. VISIONARY-MS has enrolled patients at centers in Australia and recently expanded the trial sites in North America. Dr. Glanzman presented the interim data during a joint symposium of the North American Imaging in MS Cooperative and the International Multiple Sclerosis Visual System Consortium at the meeting held by the Americas Committee for Treatment and Research in Multiple Sclerosis.

VISIONARY-MS is enrolling participants with chronic optic neuropathy, defined as visual impairment with no episodes of acute optic neuritis within the 6 months prior to enrollment, and nonactive disease, defined as no MS relapses within the prior 3 months. Patients may take concomitant immunomodulatory disease-modifying MS therapies during the trial.

The primary endpoint is improvement in low-contrast letter acuity (LCLA) from baseline to week 24. Secondary endpoints are change in amplitude and latency of multifocal visual evoked potential. Other functional measures are exploratory endpoints. Participants remain in the trial through week 48 or until the last participant completes week 24.

Among the first 34 enrolled participants, median LCLA improved by about five letters, Dr. Glanzman said. Patients also had median improvement on other subscales of the modified Multiple Sclerosis Functional Composite (MSFC) that assess cognition (Symbol Digit Modalities Test), upper extremity function (9-Hole Peg Test), and gait (Timed 25-foot Walk). CNM-Au8 has been well tolerated, and no serious adverse events related to the study drug have been reported. The most frequent adverse events include headache, upper respiratory infection, and sore throat. Full unblinded results are anticipated in 2021.

About 60% of patients in the interim analysis were female, and the mean Expanded Disability Status Scale score was less than 2, Dr. Glanzman said.

“These data add to the growing body of clinical evidence demonstrating that CNM-Au8, a suspension of catalytic, clean-surfaced, faceted gold nanocrystals, has the unique ability to improve remyelination and provide axonal neuroprotection,” Dr. Glanzman said in a news release. “The consistent median improvements observed across the MSFC functional domains in the population of participants in VISIONARY-MS are exciting.”

At previous meetings, research has described data from studies that have provided evidence of efficacy in animal models of MS. An overview of the preclinical studies – “Nanocatalytic activity of clean-surfaced, faceted nanocrystalline gold enhances remyelination in animal models of multiple sclerosis” – was published recently in Scientific Reports (2020 Feb 11;10[1]:1936). Preclinical studies in animal models of diseases other than MS also have shown evidence of neuroprotection, Dr. Glanzman said.

“We are studying the visual system in order to interrogate the nervous system as a whole,” he said. “The visual system is by far the most sensitive to change.” The design of VISIONARY-MS was informed by a trial of clemastine fumarate as a potential remyelinating agent in patients with chronic optic neuropathy, Dr. Glanzman added.

Dr. Glanzman is an employee of Clene Nanomedicine, and receives salary and stock options.

jremaly@mdedge.com

SOURCE: Glanzman R. ACTRIMS Forum 2020, Abstract.

WEST PALM BEACH, FLA. – Among patients with relapsing multiple sclerosis (MS) and visual impairment who received a potential remyelinating treatment or placebo for as long as 36 weeks, median low-contrast letter acuity improved in the population overall, according to an interim, blinded analysis. Exploratory outcome measures of cognition, gait, and upper extremity function also improved.

Jake Remaly/MDedge News

The results do not mean that the treatment works. “We know that placebo works. I’m not here to tell you that the drug works. I’m just here to tell you that we have intriguing data,” said Robert Glanzman, MD, chief medical officer of Clene Nanomedicine, the developer of the drug.

The patients in the interim analysis represent about 25% of the target study population of 150 patients, Dr. Glanzman said. The phase 2, double-blind, randomized, controlled trial, VISIONARY-MS, is assessing the efficacy and safety of CNM-Au8, a suspension of clean-surfaced gold nanocrystals that may support intracellular biologic processes. Patients are randomly assigned to receive low-dose CNM-Au8, high-dose CNM-Au8, or placebo taken orally once daily.

Neuroprotective or remyelinating agents are an unmet need in MS, Dr. Glanzman said. VISIONARY-MS has enrolled patients at centers in Australia and recently expanded the trial sites in North America. Dr. Glanzman presented the interim data during a joint symposium of the North American Imaging in MS Cooperative and the International Multiple Sclerosis Visual System Consortium at the meeting held by the Americas Committee for Treatment and Research in Multiple Sclerosis.

VISIONARY-MS is enrolling participants with chronic optic neuropathy, defined as visual impairment with no episodes of acute optic neuritis within the 6 months prior to enrollment, and nonactive disease, defined as no MS relapses within the prior 3 months. Patients may take concomitant immunomodulatory disease-modifying MS therapies during the trial.

The primary endpoint is improvement in low-contrast letter acuity (LCLA) from baseline to week 24. Secondary endpoints are change in amplitude and latency of multifocal visual evoked potential. Other functional measures are exploratory endpoints. Participants remain in the trial through week 48 or until the last participant completes week 24.

Among the first 34 enrolled participants, median LCLA improved by about five letters, Dr. Glanzman said. Patients also had median improvement on other subscales of the modified Multiple Sclerosis Functional Composite (MSFC) that assess cognition (Symbol Digit Modalities Test), upper extremity function (9-Hole Peg Test), and gait (Timed 25-foot Walk). CNM-Au8 has been well tolerated, and no serious adverse events related to the study drug have been reported. The most frequent adverse events include headache, upper respiratory infection, and sore throat. Full unblinded results are anticipated in 2021.

About 60% of patients in the interim analysis were female, and the mean Expanded Disability Status Scale score was less than 2, Dr. Glanzman said.

“These data add to the growing body of clinical evidence demonstrating that CNM-Au8, a suspension of catalytic, clean-surfaced, faceted gold nanocrystals, has the unique ability to improve remyelination and provide axonal neuroprotection,” Dr. Glanzman said in a news release. “The consistent median improvements observed across the MSFC functional domains in the population of participants in VISIONARY-MS are exciting.”

At previous meetings, research has described data from studies that have provided evidence of efficacy in animal models of MS. An overview of the preclinical studies – “Nanocatalytic activity of clean-surfaced, faceted nanocrystalline gold enhances remyelination in animal models of multiple sclerosis” – was published recently in Scientific Reports (2020 Feb 11;10[1]:1936). Preclinical studies in animal models of diseases other than MS also have shown evidence of neuroprotection, Dr. Glanzman said.

“We are studying the visual system in order to interrogate the nervous system as a whole,” he said. “The visual system is by far the most sensitive to change.” The design of VISIONARY-MS was informed by a trial of clemastine fumarate as a potential remyelinating agent in patients with chronic optic neuropathy, Dr. Glanzman added.

Dr. Glanzman is an employee of Clene Nanomedicine, and receives salary and stock options.

jremaly@mdedge.com

SOURCE: Glanzman R. ACTRIMS Forum 2020, Abstract.

WEST PALM BEACH, FLA. – Cancer incidence among patients with multiple sclerosis (MS) treated after the advent of immune therapies showed an increase, compared with prior generations, according to a large study of Norwegian MS patients.

“We detected a similar cancer risk among MS patients, compared to the general Norwegian population before 1996, [however] MS patients had increased risk of cancer compared to the general population after 1996,” first author Nina Grytten, PhD, of the department of neurology at the Norwegian Multiple Sclerosis Centre, Bergen, Norway, said in an interview at the meeting held by the Americas Committee for Treatment and Research in Multiple Sclerosis.

“This finding suggests that clinicians should be aware of this increased risk of cancer when caring for MS patients.”

With the widespread use of disease-modifying therapies (DMTs) in patients with MS, such findings are always of interest to clinicians and patients alike, commented ACTRIMS president, Jeffrey A. Cohen, MD.

“Something that’s already on the mind of most people with MS is what are the long-term safety characteristics of these medicines because we’re talking about a life-long therapy for most people,” Dr. Cohen, who is the director of Experimental Therapeutics at the Mellen Center for MS Treatment and Research at the Cleveland Clinic, said in an interview.

“With such a large sample size and such a long study, this is on one hand reassuring and tells us the cancer risk is likely low, but it also suggests that it’s something we should pay attention to,” he said.

In previous research, Dr. Grytten and her team identified an increased risk of cancer among patients with MS in Norway, but conflicting results have been reported in other studies looking at cancer risk and MS.

The authors therefore sought to dig deeper into the risk in the Norwegian population, looking into the specifics of cancer incidence according to sex and the period of diagnosis.

For the study, they identified a total of 6,638 patients with MS from previous prevalence studies in Norway, as well as in the Norwegian MS Registry and Biobank.

The data from the cohort was matched with 36,957 Norwegian citizens without MS in a 5:1 ratio, with the participants matched according to age, gender, and county. The cohort was further linked to data from the Norwegian Cancer Registry for additional information on the year and type of cancer diagnosis, as well as cause and year of death data. The participants were born between 1930 and 1979.

Over the course of the full 65-year observation period, the cancer diagnosis rates were similar between participants with MS (774; 11.2%) and those without MS (4,017; 10.6%).

And in looking at cancer incidence rate ratios of those with MS, compared with controls between the years 1953 and 1995, the rate was similar (IRR, 1.05; 95% confidence interval, 0.97-1.14). However, after 1995, the rate increased, with a higher cancer incidence among MS patients, compared with those without MS (IRR, 1.40; 95% CI, 1.30-1.51).

Cancer rates were additionally higher among those with MS in cancers of various organs, including the brain (IRR, 1.75; 95% CI, 1.28-2.40), meninges (IRR, 2.28; 95% CI, 1.47-3.53), urinary organs (IRR, 2.06; 95% CI, 1.52-2.79), digestive system (IRR, 1.47; 95% CI, 1.20-1.80), endocrine glands (IRR, 1.64; 95% CI, 1.06-2.54), and respiratory organs (IRR, 2.05; 95% CI, 1.55-2.07).

Dr. Grytten noted, however, that the study cannot rule out various other possible causes for the differences. For instance, “cancer in urinary system and respiratory organs showed increased risk in MS both before and after introduction of disease-modifying therapies,” she noted. “Those are possibly caused by smoking, which is a habit more common among MS patients in Norway.”

Furthermore, “increased cancer in the central nervous system in MS could possibly be explained by frequent use of magnetic resonance imaging and the ability to detect CNS cancer at early stages.”

“There is increasing evidence that patients with MS are also more susceptible to other diseases, and increased cancer risk seems to be one of these comorbidities.”

However, the finding that increased cancers were observed after 1996 in other organs in MS patients as well does raise the issue of a possible role of DMTs.

Of note, mitoxantrone has been associated with an increased risk of leukemia and colorectal cancer.

And “other immunosuppressant drugs, including the MS drug fingolimod, are believed to possibly be linked to an increased cancer risk, although evidence has not yet been established,” Dr. Grytten said.

“The increased risk of cancer associated with MS was detected in the era of disease-modifying treatment of MS, and this association suggests that DMTs might possibly increase cancer risk.”

In general, “clinicians should be aware of comorbidity in MS,” Dr. Grytten said. “More data is needed on the long-time effects of immunomodulatory treatment.”

Dr. Cohen added that, in addition to mitoxantrone, azathioprine and cyclophosphamide have shown risk, but “clinical trials and follow-up studies of individual MS DMTs have not shown clear cut increased risk of cancer, which is reassuring.”

“Nevertheless, this study suggests that, in aggregate, there may be a mild increased risk. There are many other potential explanations, so the research needs to be followed up,” he said.

Dr. Cohen reported receiving personal compensation for consulting for Adamas, Convelo, MedDay, Mylan, and Population Council; and serving as an Editor of Multiple Sclerosis Journal.

SOURCE: Torkildsen NG et al. ACTRIMS Forum 2020, Abstract P126.

WEST PALM BEACH, FLA. – Cancer incidence among patients with multiple sclerosis (MS) treated after the advent of immune therapies showed an increase, compared with prior generations, according to a large study of Norwegian MS patients.

“We detected a similar cancer risk among MS patients, compared to the general Norwegian population before 1996, [however] MS patients had increased risk of cancer compared to the general population after 1996,” first author Nina Grytten, PhD, of the department of neurology at the Norwegian Multiple Sclerosis Centre, Bergen, Norway, said in an interview at the meeting held by the Americas Committee for Treatment and Research in Multiple Sclerosis.

“This finding suggests that clinicians should be aware of this increased risk of cancer when caring for MS patients.”

With the widespread use of disease-modifying therapies (DMTs) in patients with MS, such findings are always of interest to clinicians and patients alike, commented ACTRIMS president, Jeffrey A. Cohen, MD.

“Something that’s already on the mind of most people with MS is what are the long-term safety characteristics of these medicines because we’re talking about a life-long therapy for most people,” Dr. Cohen, who is the director of Experimental Therapeutics at the Mellen Center for MS Treatment and Research at the Cleveland Clinic, said in an interview.

“With such a large sample size and such a long study, this is on one hand reassuring and tells us the cancer risk is likely low, but it also suggests that it’s something we should pay attention to,” he said.

In previous research, Dr. Grytten and her team identified an increased risk of cancer among patients with MS in Norway, but conflicting results have been reported in other studies looking at cancer risk and MS.

The authors therefore sought to dig deeper into the risk in the Norwegian population, looking into the specifics of cancer incidence according to sex and the period of diagnosis.

For the study, they identified a total of 6,638 patients with MS from previous prevalence studies in Norway, as well as in the Norwegian MS Registry and Biobank.

The data from the cohort was matched with 36,957 Norwegian citizens without MS in a 5:1 ratio, with the participants matched according to age, gender, and county. The cohort was further linked to data from the Norwegian Cancer Registry for additional information on the year and type of cancer diagnosis, as well as cause and year of death data. The participants were born between 1930 and 1979.

Over the course of the full 65-year observation period, the cancer diagnosis rates were similar between participants with MS (774; 11.2%) and those without MS (4,017; 10.6%).

And in looking at cancer incidence rate ratios of those with MS, compared with controls between the years 1953 and 1995, the rate was similar (IRR, 1.05; 95% confidence interval, 0.97-1.14). However, after 1995, the rate increased, with a higher cancer incidence among MS patients, compared with those without MS (IRR, 1.40; 95% CI, 1.30-1.51).

Cancer rates were additionally higher among those with MS in cancers of various organs, including the brain (IRR, 1.75; 95% CI, 1.28-2.40), meninges (IRR, 2.28; 95% CI, 1.47-3.53), urinary organs (IRR, 2.06; 95% CI, 1.52-2.79), digestive system (IRR, 1.47; 95% CI, 1.20-1.80), endocrine glands (IRR, 1.64; 95% CI, 1.06-2.54), and respiratory organs (IRR, 2.05; 95% CI, 1.55-2.07).

Dr. Grytten noted, however, that the study cannot rule out various other possible causes for the differences. For instance, “cancer in urinary system and respiratory organs showed increased risk in MS both before and after introduction of disease-modifying therapies,” she noted. “Those are possibly caused by smoking, which is a habit more common among MS patients in Norway.”

Furthermore, “increased cancer in the central nervous system in MS could possibly be explained by frequent use of magnetic resonance imaging and the ability to detect CNS cancer at early stages.”

“There is increasing evidence that patients with MS are also more susceptible to other diseases, and increased cancer risk seems to be one of these comorbidities.”

However, the finding that increased cancers were observed after 1996 in other organs in MS patients as well does raise the issue of a possible role of DMTs.

Of note, mitoxantrone has been associated with an increased risk of leukemia and colorectal cancer.

And “other immunosuppressant drugs, including the MS drug fingolimod, are believed to possibly be linked to an increased cancer risk, although evidence has not yet been established,” Dr. Grytten said.

“The increased risk of cancer associated with MS was detected in the era of disease-modifying treatment of MS, and this association suggests that DMTs might possibly increase cancer risk.”

In general, “clinicians should be aware of comorbidity in MS,” Dr. Grytten said. “More data is needed on the long-time effects of immunomodulatory treatment.”

Dr. Cohen added that, in addition to mitoxantrone, azathioprine and cyclophosphamide have shown risk, but “clinical trials and follow-up studies of individual MS DMTs have not shown clear cut increased risk of cancer, which is reassuring.”

“Nevertheless, this study suggests that, in aggregate, there may be a mild increased risk. There are many other potential explanations, so the research needs to be followed up,” he said.

Dr. Cohen reported receiving personal compensation for consulting for Adamas, Convelo, MedDay, Mylan, and Population Council; and serving as an Editor of Multiple Sclerosis Journal.

SOURCE: Torkildsen NG et al. ACTRIMS Forum 2020, Abstract P126.

WEST PALM BEACH, FLA. – Cancer incidence among patients with multiple sclerosis (MS) treated after the advent of immune therapies showed an increase, compared with prior generations, according to a large study of Norwegian MS patients.

“We detected a similar cancer risk among MS patients, compared to the general Norwegian population before 1996, [however] MS patients had increased risk of cancer compared to the general population after 1996,” first author Nina Grytten, PhD, of the department of neurology at the Norwegian Multiple Sclerosis Centre, Bergen, Norway, said in an interview at the meeting held by the Americas Committee for Treatment and Research in Multiple Sclerosis.

“This finding suggests that clinicians should be aware of this increased risk of cancer when caring for MS patients.”

With the widespread use of disease-modifying therapies (DMTs) in patients with MS, such findings are always of interest to clinicians and patients alike, commented ACTRIMS president, Jeffrey A. Cohen, MD.

“Something that’s already on the mind of most people with MS is what are the long-term safety characteristics of these medicines because we’re talking about a life-long therapy for most people,” Dr. Cohen, who is the director of Experimental Therapeutics at the Mellen Center for MS Treatment and Research at the Cleveland Clinic, said in an interview.

“With such a large sample size and such a long study, this is on one hand reassuring and tells us the cancer risk is likely low, but it also suggests that it’s something we should pay attention to,” he said.

In previous research, Dr. Grytten and her team identified an increased risk of cancer among patients with MS in Norway, but conflicting results have been reported in other studies looking at cancer risk and MS.

The authors therefore sought to dig deeper into the risk in the Norwegian population, looking into the specifics of cancer incidence according to sex and the period of diagnosis.

For the study, they identified a total of 6,638 patients with MS from previous prevalence studies in Norway, as well as in the Norwegian MS Registry and Biobank.

The data from the cohort was matched with 36,957 Norwegian citizens without MS in a 5:1 ratio, with the participants matched according to age, gender, and county. The cohort was further linked to data from the Norwegian Cancer Registry for additional information on the year and type of cancer diagnosis, as well as cause and year of death data. The participants were born between 1930 and 1979.

Over the course of the full 65-year observation period, the cancer diagnosis rates were similar between participants with MS (774; 11.2%) and those without MS (4,017; 10.6%).

And in looking at cancer incidence rate ratios of those with MS, compared with controls between the years 1953 and 1995, the rate was similar (IRR, 1.05; 95% confidence interval, 0.97-1.14). However, after 1995, the rate increased, with a higher cancer incidence among MS patients, compared with those without MS (IRR, 1.40; 95% CI, 1.30-1.51).

Cancer rates were additionally higher among those with MS in cancers of various organs, including the brain (IRR, 1.75; 95% CI, 1.28-2.40), meninges (IRR, 2.28; 95% CI, 1.47-3.53), urinary organs (IRR, 2.06; 95% CI, 1.52-2.79), digestive system (IRR, 1.47; 95% CI, 1.20-1.80), endocrine glands (IRR, 1.64; 95% CI, 1.06-2.54), and respiratory organs (IRR, 2.05; 95% CI, 1.55-2.07).

Dr. Grytten noted, however, that the study cannot rule out various other possible causes for the differences. For instance, “cancer in urinary system and respiratory organs showed increased risk in MS both before and after introduction of disease-modifying therapies,” she noted. “Those are possibly caused by smoking, which is a habit more common among MS patients in Norway.”

Furthermore, “increased cancer in the central nervous system in MS could possibly be explained by frequent use of magnetic resonance imaging and the ability to detect CNS cancer at early stages.”

“There is increasing evidence that patients with MS are also more susceptible to other diseases, and increased cancer risk seems to be one of these comorbidities.”

However, the finding that increased cancers were observed after 1996 in other organs in MS patients as well does raise the issue of a possible role of DMTs.

Of note, mitoxantrone has been associated with an increased risk of leukemia and colorectal cancer.

And “other immunosuppressant drugs, including the MS drug fingolimod, are believed to possibly be linked to an increased cancer risk, although evidence has not yet been established,” Dr. Grytten said.

“The increased risk of cancer associated with MS was detected in the era of disease-modifying treatment of MS, and this association suggests that DMTs might possibly increase cancer risk.”

In general, “clinicians should be aware of comorbidity in MS,” Dr. Grytten said. “More data is needed on the long-time effects of immunomodulatory treatment.”

Dr. Cohen added that, in addition to mitoxantrone, azathioprine and cyclophosphamide have shown risk, but “clinical trials and follow-up studies of individual MS DMTs have not shown clear cut increased risk of cancer, which is reassuring.”

“Nevertheless, this study suggests that, in aggregate, there may be a mild increased risk. There are many other potential explanations, so the research needs to be followed up,” he said.

Dr. Cohen reported receiving personal compensation for consulting for Adamas, Convelo, MedDay, Mylan, and Population Council; and serving as an Editor of Multiple Sclerosis Journal.

SOURCE: Torkildsen NG et al. ACTRIMS Forum 2020, Abstract P126.

The US Food and Drug Administration (FDA) has approved rimegepant (Nurtec ODT, Biohaven), the first calcitonin gene-related peptide (CGRP) receptor antagonist available in a fast-acting orally disintegrating tablet for the acute treatment of migraine in adults.

This story first appeared on Medscape.com.

The US Food and Drug Administration (FDA) has approved rimegepant (Nurtec ODT, Biohaven), the first calcitonin gene-related peptide (CGRP) receptor antagonist available in a fast-acting orally disintegrating tablet for the acute treatment of migraine in adults.

This story first appeared on Medscape.com.

The US Food and Drug Administration (FDA) has approved rimegepant (Nurtec ODT, Biohaven), the first calcitonin gene-related peptide (CGRP) receptor antagonist available in a fast-acting orally disintegrating tablet for the acute treatment of migraine in adults.

This story first appeared on Medscape.com.

WEST PALM BEACH, FLA. – Patients with pediatric-onset multiple sclerosis (POMS) have less higher education and greater use of high-efficacy disease-modifying therapy (DMT), compared with patients with adult-onset MS (AOMS), according to data presented at the meeting held by the Americas Committee for Treatment and Research in Multiple Sclerosis.

Among patients with POMS, researchers also have observed an association between fatigue and mood disorders on one hand and DMT choice on the other hand. “These findings confirm the unique features of POMS and suggest that DMT choice in POMS and AOMS may influence the frequency of fatigue and mood disorders,” said Mary Rensel, MD, staff neurologist in neuroimmunology at Cleveland Clinic’s Mellen Center for MS Treatment and Research, and colleagues.

POMS is defined as MS onset before age 18, and the disease characteristics of POMS and AOMS are distinct. The former diagnosis is rare, which has limited the amount of data collected on POMS to date.

MS Partners Advancing Technology and Health Solutions (MS-PATHS), sponsored by Biogen, is a multicenter initiative in which researchers collect MS performance measures longitudinally at each patient visit. MS-PATHS data include sociodemographic information, patient-reported outcomes (PROs), functional outcomes (FOs), MS phenotype, and DMT. Using MS-PATHS data, Dr. Rensel and colleagues sought to determine differences in sociodemographics, MS phenotype, PRO, FO, and DMT among patients with POMS and between patients with POMS and those with AOMS.

The investigators analyzed data cut 9 of the MS-PATHS database for their study. They included 637 participants with POMS and matched them with patients with AOMS, based on disease duration, in a 1:5 ratio. Dr. Rensel and colleagues categorized DMTs as high, mid, or low efficacy. They calculated descriptive statistics to characterize the study population. In addition, they compared MS FOs and PROs in the matched cohort using the Wilcoxon rank-sum test. Finally, linear regression analysis allowed the investigators to identify differences in the data set, while adjusting for important covariates.

The matched cohort included 5,857 patients with AOMS and 600 patients with POMS. The patients with AOMS had an average age of 49.8 years. About 87.5% of these patients were white, and 73.5% were female. The POMS patients had an average age of 31.49 years. Overall, 76.7% of these patients were white, and 73.2% were female. Dr. Rensel and colleagues found significant differences between the two groups in age at encounter, disease duration, race, insurance, Patient Determined Disease Steps (PDDS), education, employment, FOs, PROs, and DMT.

Patients with POMS used high-efficacy DMT more frequently than those with AOMS. The rate of depression was similar between patients with AOMS and those with POMS. Depression, anxiety, and fatigue were associated with DMT potency in AOMS, and anxiety and fatigue were associated with DMT groups in POMS.

Racial differences between POMS and AOMS have been reported previously, said Dr. Rensel. First-generation immigrant children have an increased risk of POMS, compared with other children. “In our data set, we had more Asians, more blacks, and fewer Caucasians in the POMS group,” said Dr. Rensel. People from a socioeconomically challenged environment have an increased risk of POMS, and this observation may explain the difference in insurance coverage between the POMS and AOMS groups, she added. Socioeconomic challenges also may explain the difference in the rate of higher education between the two groups.

“Why were the POMS cases associated with higher-efficacy DMT when only one oral MS DMT is [Food and Drug Administration]-approved for POMS?” Dr. Rensel asked. “This is likely due to the fact that POMS cases tend to have higher disease activity with more relapses and more brain lesions, leading to the choice of higher efficacy DMTs that are currently not FDA-approved for POMS.”

These data “may help [clinicians] caring for kids and teens, especially non-Caucasian [patients], to consider MS on the differential diagnosis,” Dr. Rensel added. “Mood disorders in POMS were as common as mood disorders in AOMS, so these should be screened for in this POMS population.”

Dr. Rensel has received funding for consulting, research, or patient education from Biogen, Genentech, Genzyme, Medimmune, MSAA, NMSS, Novartis, TSerono, and Teva.

egreb@mdedge.com

SOURCE: Rensel M et al. ACTRIMS Forum 2020, Abstract P042.

WEST PALM BEACH, FLA. – Patients with pediatric-onset multiple sclerosis (POMS) have less higher education and greater use of high-efficacy disease-modifying therapy (DMT), compared with patients with adult-onset MS (AOMS), according to data presented at the meeting held by the Americas Committee for Treatment and Research in Multiple Sclerosis.

Among patients with POMS, researchers also have observed an association between fatigue and mood disorders on one hand and DMT choice on the other hand. “These findings confirm the unique features of POMS and suggest that DMT choice in POMS and AOMS may influence the frequency of fatigue and mood disorders,” said Mary Rensel, MD, staff neurologist in neuroimmunology at Cleveland Clinic’s Mellen Center for MS Treatment and Research, and colleagues.

POMS is defined as MS onset before age 18, and the disease characteristics of POMS and AOMS are distinct. The former diagnosis is rare, which has limited the amount of data collected on POMS to date.

MS Partners Advancing Technology and Health Solutions (MS-PATHS), sponsored by Biogen, is a multicenter initiative in which researchers collect MS performance measures longitudinally at each patient visit. MS-PATHS data include sociodemographic information, patient-reported outcomes (PROs), functional outcomes (FOs), MS phenotype, and DMT. Using MS-PATHS data, Dr. Rensel and colleagues sought to determine differences in sociodemographics, MS phenotype, PRO, FO, and DMT among patients with POMS and between patients with POMS and those with AOMS.

The investigators analyzed data cut 9 of the MS-PATHS database for their study. They included 637 participants with POMS and matched them with patients with AOMS, based on disease duration, in a 1:5 ratio. Dr. Rensel and colleagues categorized DMTs as high, mid, or low efficacy. They calculated descriptive statistics to characterize the study population. In addition, they compared MS FOs and PROs in the matched cohort using the Wilcoxon rank-sum test. Finally, linear regression analysis allowed the investigators to identify differences in the data set, while adjusting for important covariates.

The matched cohort included 5,857 patients with AOMS and 600 patients with POMS. The patients with AOMS had an average age of 49.8 years. About 87.5% of these patients were white, and 73.5% were female. The POMS patients had an average age of 31.49 years. Overall, 76.7% of these patients were white, and 73.2% were female. Dr. Rensel and colleagues found significant differences between the two groups in age at encounter, disease duration, race, insurance, Patient Determined Disease Steps (PDDS), education, employment, FOs, PROs, and DMT.

Patients with POMS used high-efficacy DMT more frequently than those with AOMS. The rate of depression was similar between patients with AOMS and those with POMS. Depression, anxiety, and fatigue were associated with DMT potency in AOMS, and anxiety and fatigue were associated with DMT groups in POMS.

Racial differences between POMS and AOMS have been reported previously, said Dr. Rensel. First-generation immigrant children have an increased risk of POMS, compared with other children. “In our data set, we had more Asians, more blacks, and fewer Caucasians in the POMS group,” said Dr. Rensel. People from a socioeconomically challenged environment have an increased risk of POMS, and this observation may explain the difference in insurance coverage between the POMS and AOMS groups, she added. Socioeconomic challenges also may explain the difference in the rate of higher education between the two groups.

“Why were the POMS cases associated with higher-efficacy DMT when only one oral MS DMT is [Food and Drug Administration]-approved for POMS?” Dr. Rensel asked. “This is likely due to the fact that POMS cases tend to have higher disease activity with more relapses and more brain lesions, leading to the choice of higher efficacy DMTs that are currently not FDA-approved for POMS.”

These data “may help [clinicians] caring for kids and teens, especially non-Caucasian [patients], to consider MS on the differential diagnosis,” Dr. Rensel added. “Mood disorders in POMS were as common as mood disorders in AOMS, so these should be screened for in this POMS population.”

Dr. Rensel has received funding for consulting, research, or patient education from Biogen, Genentech, Genzyme, Medimmune, MSAA, NMSS, Novartis, TSerono, and Teva.

egreb@mdedge.com

SOURCE: Rensel M et al. ACTRIMS Forum 2020, Abstract P042.

WEST PALM BEACH, FLA. – Patients with pediatric-onset multiple sclerosis (POMS) have less higher education and greater use of high-efficacy disease-modifying therapy (DMT), compared with patients with adult-onset MS (AOMS), according to data presented at the meeting held by the Americas Committee for Treatment and Research in Multiple Sclerosis.

Among patients with POMS, researchers also have observed an association between fatigue and mood disorders on one hand and DMT choice on the other hand. “These findings confirm the unique features of POMS and suggest that DMT choice in POMS and AOMS may influence the frequency of fatigue and mood disorders,” said Mary Rensel, MD, staff neurologist in neuroimmunology at Cleveland Clinic’s Mellen Center for MS Treatment and Research, and colleagues.

POMS is defined as MS onset before age 18, and the disease characteristics of POMS and AOMS are distinct. The former diagnosis is rare, which has limited the amount of data collected on POMS to date.

MS Partners Advancing Technology and Health Solutions (MS-PATHS), sponsored by Biogen, is a multicenter initiative in which researchers collect MS performance measures longitudinally at each patient visit. MS-PATHS data include sociodemographic information, patient-reported outcomes (PROs), functional outcomes (FOs), MS phenotype, and DMT. Using MS-PATHS data, Dr. Rensel and colleagues sought to determine differences in sociodemographics, MS phenotype, PRO, FO, and DMT among patients with POMS and between patients with POMS and those with AOMS.

The investigators analyzed data cut 9 of the MS-PATHS database for their study. They included 637 participants with POMS and matched them with patients with AOMS, based on disease duration, in a 1:5 ratio. Dr. Rensel and colleagues categorized DMTs as high, mid, or low efficacy. They calculated descriptive statistics to characterize the study population. In addition, they compared MS FOs and PROs in the matched cohort using the Wilcoxon rank-sum test. Finally, linear regression analysis allowed the investigators to identify differences in the data set, while adjusting for important covariates.

The matched cohort included 5,857 patients with AOMS and 600 patients with POMS. The patients with AOMS had an average age of 49.8 years. About 87.5% of these patients were white, and 73.5% were female. The POMS patients had an average age of 31.49 years. Overall, 76.7% of these patients were white, and 73.2% were female. Dr. Rensel and colleagues found significant differences between the two groups in age at encounter, disease duration, race, insurance, Patient Determined Disease Steps (PDDS), education, employment, FOs, PROs, and DMT.

Patients with POMS used high-efficacy DMT more frequently than those with AOMS. The rate of depression was similar between patients with AOMS and those with POMS. Depression, anxiety, and fatigue were associated with DMT potency in AOMS, and anxiety and fatigue were associated with DMT groups in POMS.

Racial differences between POMS and AOMS have been reported previously, said Dr. Rensel. First-generation immigrant children have an increased risk of POMS, compared with other children. “In our data set, we had more Asians, more blacks, and fewer Caucasians in the POMS group,” said Dr. Rensel. People from a socioeconomically challenged environment have an increased risk of POMS, and this observation may explain the difference in insurance coverage between the POMS and AOMS groups, she added. Socioeconomic challenges also may explain the difference in the rate of higher education between the two groups.

“Why were the POMS cases associated with higher-efficacy DMT when only one oral MS DMT is [Food and Drug Administration]-approved for POMS?” Dr. Rensel asked. “This is likely due to the fact that POMS cases tend to have higher disease activity with more relapses and more brain lesions, leading to the choice of higher efficacy DMTs that are currently not FDA-approved for POMS.”

These data “may help [clinicians] caring for kids and teens, especially non-Caucasian [patients], to consider MS on the differential diagnosis,” Dr. Rensel added. “Mood disorders in POMS were as common as mood disorders in AOMS, so these should be screened for in this POMS population.”

Dr. Rensel has received funding for consulting, research, or patient education from Biogen, Genentech, Genzyme, Medimmune, MSAA, NMSS, Novartis, TSerono, and Teva.

egreb@mdedge.com

SOURCE: Rensel M et al. ACTRIMS Forum 2020, Abstract P042.

womensWEST PALM BEACH, FLA. – Patients with multiple sclerosis (MS) are at increased risk for most types of infection, with the highest risk associated with renal tract infections, according to an analysis of Department of Defense data.

Susan Jick, DSc, director of the Boston Collaborative Drug Surveillance Program and professor of epidemiology and biostatistics at Boston University, and colleagues sought to understand the rates at which infections occur because they are known to be a common cause of comorbidity and death in patients with MS.

At the meeting held by the Americas Committee for Treatment and Research in Multiple Sclerosis, Dr. Jick and associates presented rates of infection in patients with MS after MS diagnosis, compared with a matched population of patients without MS. The MS cohort included patients who had MS diagnosed and treated between January 2004 and August 2017. Patients had medical history available for at least 1 year before MS diagnosis and at least one prescription for an MS disease-modifying treatment.

Patients without MS were matched to patients with MS 10:1 based on age, sex, geographic region, and cohort entry date. For each patient, the researchers identified the first diagnosed infection of each type after cohort entry. They followed patients until loss of eligibility, death, or end of data collection.

In all, the study included 8,695 patients with MS and 86,934 matched patients without MS. The median age at cohort entry was 41 years, and 71% were female. Median duration of follow-up after study entry was about 6 years. Patients with MS were more likely to have an infection in the year before cohort entry, compared with non-MS patients (43.9% vs. 36.3%).

After cohort entry, the incidence rate of any infection was higher among patients with MS, compared with non-MS patients (4,805 vs. 2,731 per 10,000 person-years; IR ratio, 1.76). In addition, the IR of hospitalized infection was higher among MS patients (125 vs. 51.3 per 10,000 person-years; IRR, 2.43). The IR also was increased for several other types of infections, including renal, skin, fungal, pneumonia or influenza, and other infections (such as rickettsial and spirochetal diseases, helminthiases, and nonsyphilitic and nongonococcal venereal diseases). Eye or ear, respiratory or throat, and viral IRRs “were marginally elevated,” the investigators wrote.

In both cohorts, females had a higher risk of infection than males did. The rate of renal tract infection was more than fourfold higher among females, compared with males, in both cohorts. Relative to non-MS patients, however, men with MS had a higher IRR for renal tract infection than women with MS did (2.47 vs. 1.90).

“The risk for any opportunistic infection was slightly increased among MS patients,” the researchers wrote (520 vs. 338 per 10,000 person-years; IRR, 1.54). This was particularly true for candidiasis (252 vs. 166 per 10,000 person-years; IRR, 1.52) and herpes virus infection (221 vs. 150 per 10,000 person-years; IRR, 1.47). “There were few cases of tuberculosis, hepatitis B infection, or hepatitis C infection,” they noted.

The study was funded by a grant from Celgene, a subsidiary of Bristol-Myers Squibb. Four authors are employees of Bristol-Myers Squibb, and one author works for a company that does business with Celgene.

jremaly@mdedge.com

SOURCE: Jick S et al. ACTRIMS Forum 2020, Abstract P086.


 

womensWEST PALM BEACH, FLA. – Patients with multiple sclerosis (MS) are at increased risk for most types of infection, with the highest risk associated with renal tract infections, according to an analysis of Department of Defense data.

Susan Jick, DSc, director of the Boston Collaborative Drug Surveillance Program and professor of epidemiology and biostatistics at Boston University, and colleagues sought to understand the rates at which infections occur because they are known to be a common cause of comorbidity and death in patients with MS.

At the meeting held by the Americas Committee for Treatment and Research in Multiple Sclerosis, Dr. Jick and associates presented rates of infection in patients with MS after MS diagnosis, compared with a matched population of patients without MS. The MS cohort included patients who had MS diagnosed and treated between January 2004 and August 2017. Patients had medical history available for at least 1 year before MS diagnosis and at least one prescription for an MS disease-modifying treatment.

Patients without MS were matched to patients with MS 10:1 based on age, sex, geographic region, and cohort entry date. For each patient, the researchers identified the first diagnosed infection of each type after cohort entry. They followed patients until loss of eligibility, death, or end of data collection.

In all, the study included 8,695 patients with MS and 86,934 matched patients without MS. The median age at cohort entry was 41 years, and 71% were female. Median duration of follow-up after study entry was about 6 years. Patients with MS were more likely to have an infection in the year before cohort entry, compared with non-MS patients (43.9% vs. 36.3%).

After cohort entry, the incidence rate of any infection was higher among patients with MS, compared with non-MS patients (4,805 vs. 2,731 per 10,000 person-years; IR ratio, 1.76). In addition, the IR of hospitalized infection was higher among MS patients (125 vs. 51.3 per 10,000 person-years; IRR, 2.43). The IR also was increased for several other types of infections, including renal, skin, fungal, pneumonia or influenza, and other infections (such as rickettsial and spirochetal diseases, helminthiases, and nonsyphilitic and nongonococcal venereal diseases). Eye or ear, respiratory or throat, and viral IRRs “were marginally elevated,” the investigators wrote.

In both cohorts, females had a higher risk of infection than males did. The rate of renal tract infection was more than fourfold higher among females, compared with males, in both cohorts. Relative to non-MS patients, however, men with MS had a higher IRR for renal tract infection than women with MS did (2.47 vs. 1.90).

“The risk for any opportunistic infection was slightly increased among MS patients,” the researchers wrote (520 vs. 338 per 10,000 person-years; IRR, 1.54). This was particularly true for candidiasis (252 vs. 166 per 10,000 person-years; IRR, 1.52) and herpes virus infection (221 vs. 150 per 10,000 person-years; IRR, 1.47). “There were few cases of tuberculosis, hepatitis B infection, or hepatitis C infection,” they noted.

The study was funded by a grant from Celgene, a subsidiary of Bristol-Myers Squibb. Four authors are employees of Bristol-Myers Squibb, and one author works for a company that does business with Celgene.

jremaly@mdedge.com

SOURCE: Jick S et al. ACTRIMS Forum 2020, Abstract P086.


 

womensWEST PALM BEACH, FLA. – Patients with multiple sclerosis (MS) are at increased risk for most types of infection, with the highest risk associated with renal tract infections, according to an analysis of Department of Defense data.

Susan Jick, DSc, director of the Boston Collaborative Drug Surveillance Program and professor of epidemiology and biostatistics at Boston University, and colleagues sought to understand the rates at which infections occur because they are known to be a common cause of comorbidity and death in patients with MS.

At the meeting held by the Americas Committee for Treatment and Research in Multiple Sclerosis, Dr. Jick and associates presented rates of infection in patients with MS after MS diagnosis, compared with a matched population of patients without MS. The MS cohort included patients who had MS diagnosed and treated between January 2004 and August 2017. Patients had medical history available for at least 1 year before MS diagnosis and at least one prescription for an MS disease-modifying treatment.

Patients without MS were matched to patients with MS 10:1 based on age, sex, geographic region, and cohort entry date. For each patient, the researchers identified the first diagnosed infection of each type after cohort entry. They followed patients until loss of eligibility, death, or end of data collection.

In all, the study included 8,695 patients with MS and 86,934 matched patients without MS. The median age at cohort entry was 41 years, and 71% were female. Median duration of follow-up after study entry was about 6 years. Patients with MS were more likely to have an infection in the year before cohort entry, compared with non-MS patients (43.9% vs. 36.3%).

After cohort entry, the incidence rate of any infection was higher among patients with MS, compared with non-MS patients (4,805 vs. 2,731 per 10,000 person-years; IR ratio, 1.76). In addition, the IR of hospitalized infection was higher among MS patients (125 vs. 51.3 per 10,000 person-years; IRR, 2.43). The IR also was increased for several other types of infections, including renal, skin, fungal, pneumonia or influenza, and other infections (such as rickettsial and spirochetal diseases, helminthiases, and nonsyphilitic and nongonococcal venereal diseases). Eye or ear, respiratory or throat, and viral IRRs “were marginally elevated,” the investigators wrote.

In both cohorts, females had a higher risk of infection than males did. The rate of renal tract infection was more than fourfold higher among females, compared with males, in both cohorts. Relative to non-MS patients, however, men with MS had a higher IRR for renal tract infection than women with MS did (2.47 vs. 1.90).

“The risk for any opportunistic infection was slightly increased among MS patients,” the researchers wrote (520 vs. 338 per 10,000 person-years; IRR, 1.54). This was particularly true for candidiasis (252 vs. 166 per 10,000 person-years; IRR, 1.52) and herpes virus infection (221 vs. 150 per 10,000 person-years; IRR, 1.47). “There were few cases of tuberculosis, hepatitis B infection, or hepatitis C infection,” they noted.

The study was funded by a grant from Celgene, a subsidiary of Bristol-Myers Squibb. Four authors are employees of Bristol-Myers Squibb, and one author works for a company that does business with Celgene.

jremaly@mdedge.com

SOURCE: Jick S et al. ACTRIMS Forum 2020, Abstract P086.


 

Latest guidelines on the treatment of osteoporosis have been released that include new recommendations for the use of romosozumab (Evenity) in postmenopausal women with severe osteoporosis, but they contain caveats as to which women should – and should not – receive the drug.

The updated clinical practice guideline from the Endocrine Society is in response to the approval of romosozumab by the Food and Drug Administration (FDA) in April 2019, and more recently, by the European Medicines Agency.

It was published online February 18 in the Journal of Clinical Endocrinology & Metabolism.

In the new guidelines, committee members recommend the use of romosozumab for postmenopausal women with osteoporosis at very high risk of fracture. Candidates would include women with severe osteoporosis (T-score of less than –2.5 and a prior fracture) or women with a history of multiple vertebral fractures.

Women should be treated with romosozumab for up to 1 year, followed by an antiresorptive agent to maintain bone mineral density gains and further reduce fracture risk.

“The recommended dosage is 210 mg monthly by subcutaneous injection for 12 months,” the authors wrote.

However, and very importantly, romosozumab should not be considered for women at high risk of cardiovascular disease (CVD) or cerebrovascular disease. A high risk of CVD includes women who have had a previous myocardial infarction (MI) or stroke.

Experts questioned by Medscape Medical News stressed that romosozumab should not be a first-line, or even generally a second-line, option for osteoporosis, but it can be a considered for select patients with severe osteoporosis, taking into account CV risk.

Boxed warning

In the Active-Controlled Fracture Study in Postmenopausal Women With Osteoporosis at High Risk (ARCH), there were more major adverse cardiovascular events (MACE) in the first year of the trial with romosozumab, and patients had a 31% higher risk of MACE with romosozumab, compared with the bisphosphonate alendronate.

As a result, the drug was initially rejected by a number of regulatory agencies.

In the United States and Canada, it was eventually approved with a boxed warning, which cautions against the use of the drug in patients at risk for myocardial infarction, stroke, and CVD-related death.

“Romosozumab offers promising results for postmenopausal women with severe osteoporosis or who have a history of fractures,” Clifford Rosen, MD, Maine Medical Center Research Institute in Scarborough and chair of the writing committee, said in an Endocrine Society statement. “It does, however, come with a risk of heart disease, so clinicians need to be careful when selecting patients for this therapy.”

Exact risk unknown

Asked by Medscape Medical News to comment, Kenneth Saag, MD, professor of medicine, University of Alabama at Birmingham and principle investigator of the ARCH study, said that physicians needed more data from real-world studies to resolve the issue around whether romosozumab heightens the risk of CV events in women with osteoporosis or whether that particular finding from ARCH was an artifact.

“Women who have had a recent cardiovascular event should not receive the drug,” he said, agreeing with the new guidelines.

But it remains unclear, for example, whether women who are at slightly higher risk of having a CV event by virtue of their age alone, are also at risk, he noted.

In the meantime, results from the ARCH study clearly showed that not only was romosozumab more effective than alendronate, “but it is more effective than other bone-building drugs as well,” Dr. Saag observed, and it leads to a significantly greater reduction in vertebral, nonvertebral, and hip fractures, compared with the alendronate, the current standard of care in osteoporosis.

“In patients who have very severe osteoporosis and who have had a recent fracture or who are at risk for imminent future fracture, physicians need to balance the benefit versus the risk in favor of using romosozumab,” Dr. Saag suggested.

“And while I would say most women prefer not to inject themselves, the women I have put on this medicine have all had recent fractures and they are very aware of the pain and the disability of having a broken bone, so it is something they are willing to do,” he added.
 

Not for all women

Giving his opinion, Bart Clarke, MD, of the Mayo Clinic in Rochester, Minnesota, underscored the fact that the Fracture Study in Postmenopausal Women With Osteoporosis (FRAME), again conducted in postmenopausal women, showed no increase in CV events in patients treated with romosozumab compared with placebo.

“So there are questions about what this means, because if these events really were a drug effect, then that effect would be even more evident compared with placebo and they did not see any signal of CV events [in FRAME],” said Dr. Clarke, past president of the American Society of Bone and Mineral Research.

Like everything else in medicine, “there is always some risk,” Dr. Clarke observed.

However, what physicians should do is talk to women, ensure they have not had either an MI or stroke in the last year, and if patients have severe osteoporosis and a high risk of fracture, “then we can say, here’s another option,” he suggested.

“Then, if a woman develops chest pain or shortness of breath while on the drug, [she needs] to let us know ,and then we’ll stop the drug and reassess the situation,” he added.

Dr. Clarke also pointed out that if the FDA had received further reports of CV events linked to romosozumab, physicians would know about it by now, but to his knowledge, there has been no change to the drug’s current warning label.

Furthermore, neither he nor any of his colleagues who treat metabolic bone disease at the Mayo Clinic has seen a single CV event in patients prescribed the agent.

“This is not a drug we would use as first-line for most patients, and we don’t even use it as second-line for most patients, but in people who have not responded to other drugs or who have had terrible things happen to them already, hip fracture especially, then we are saying, you can consider this, he concluded.

The guidelines were supported by the Endocrine Society. Dr. Rosen and Dr. Clarke reported no relevant financial relationships. Dr. Saag reported receiving grants and personal fees from Amgen, personal fees from Radius, and is a consultant for Amgen, Radius, Roche, and Daiichi Sankyo.

This article first appeared on Medscape.com.

Latest guidelines on the treatment of osteoporosis have been released that include new recommendations for the use of romosozumab (Evenity) in postmenopausal women with severe osteoporosis, but they contain caveats as to which women should – and should not – receive the drug.

The updated clinical practice guideline from the Endocrine Society is in response to the approval of romosozumab by the Food and Drug Administration (FDA) in April 2019, and more recently, by the European Medicines Agency.

It was published online February 18 in the Journal of Clinical Endocrinology & Metabolism.

In the new guidelines, committee members recommend the use of romosozumab for postmenopausal women with osteoporosis at very high risk of fracture. Candidates would include women with severe osteoporosis (T-score of less than –2.5 and a prior fracture) or women with a history of multiple vertebral fractures.

Women should be treated with romosozumab for up to 1 year, followed by an antiresorptive agent to maintain bone mineral density gains and further reduce fracture risk.

“The recommended dosage is 210 mg monthly by subcutaneous injection for 12 months,” the authors wrote.

However, and very importantly, romosozumab should not be considered for women at high risk of cardiovascular disease (CVD) or cerebrovascular disease. A high risk of CVD includes women who have had a previous myocardial infarction (MI) or stroke.

Experts questioned by Medscape Medical News stressed that romosozumab should not be a first-line, or even generally a second-line, option for osteoporosis, but it can be a considered for select patients with severe osteoporosis, taking into account CV risk.

Boxed warning

In the Active-Controlled Fracture Study in Postmenopausal Women With Osteoporosis at High Risk (ARCH), there were more major adverse cardiovascular events (MACE) in the first year of the trial with romosozumab, and patients had a 31% higher risk of MACE with romosozumab, compared with the bisphosphonate alendronate.

As a result, the drug was initially rejected by a number of regulatory agencies.

In the United States and Canada, it was eventually approved with a boxed warning, which cautions against the use of the drug in patients at risk for myocardial infarction, stroke, and CVD-related death.

“Romosozumab offers promising results for postmenopausal women with severe osteoporosis or who have a history of fractures,” Clifford Rosen, MD, Maine Medical Center Research Institute in Scarborough and chair of the writing committee, said in an Endocrine Society statement. “It does, however, come with a risk of heart disease, so clinicians need to be careful when selecting patients for this therapy.”

Exact risk unknown

Asked by Medscape Medical News to comment, Kenneth Saag, MD, professor of medicine, University of Alabama at Birmingham and principle investigator of the ARCH study, said that physicians needed more data from real-world studies to resolve the issue around whether romosozumab heightens the risk of CV events in women with osteoporosis or whether that particular finding from ARCH was an artifact.

“Women who have had a recent cardiovascular event should not receive the drug,” he said, agreeing with the new guidelines.

But it remains unclear, for example, whether women who are at slightly higher risk of having a CV event by virtue of their age alone, are also at risk, he noted.

In the meantime, results from the ARCH study clearly showed that not only was romosozumab more effective than alendronate, “but it is more effective than other bone-building drugs as well,” Dr. Saag observed, and it leads to a significantly greater reduction in vertebral, nonvertebral, and hip fractures, compared with the alendronate, the current standard of care in osteoporosis.

“In patients who have very severe osteoporosis and who have had a recent fracture or who are at risk for imminent future fracture, physicians need to balance the benefit versus the risk in favor of using romosozumab,” Dr. Saag suggested.

“And while I would say most women prefer not to inject themselves, the women I have put on this medicine have all had recent fractures and they are very aware of the pain and the disability of having a broken bone, so it is something they are willing to do,” he added.
 

Not for all women

Giving his opinion, Bart Clarke, MD, of the Mayo Clinic in Rochester, Minnesota, underscored the fact that the Fracture Study in Postmenopausal Women With Osteoporosis (FRAME), again conducted in postmenopausal women, showed no increase in CV events in patients treated with romosozumab compared with placebo.

“So there are questions about what this means, because if these events really were a drug effect, then that effect would be even more evident compared with placebo and they did not see any signal of CV events [in FRAME],” said Dr. Clarke, past president of the American Society of Bone and Mineral Research.

Like everything else in medicine, “there is always some risk,” Dr. Clarke observed.

However, what physicians should do is talk to women, ensure they have not had either an MI or stroke in the last year, and if patients have severe osteoporosis and a high risk of fracture, “then we can say, here’s another option,” he suggested.

“Then, if a woman develops chest pain or shortness of breath while on the drug, [she needs] to let us know ,and then we’ll stop the drug and reassess the situation,” he added.

Dr. Clarke also pointed out that if the FDA had received further reports of CV events linked to romosozumab, physicians would know about it by now, but to his knowledge, there has been no change to the drug’s current warning label.

Furthermore, neither he nor any of his colleagues who treat metabolic bone disease at the Mayo Clinic has seen a single CV event in patients prescribed the agent.

“This is not a drug we would use as first-line for most patients, and we don’t even use it as second-line for most patients, but in people who have not responded to other drugs or who have had terrible things happen to them already, hip fracture especially, then we are saying, you can consider this, he concluded.

The guidelines were supported by the Endocrine Society. Dr. Rosen and Dr. Clarke reported no relevant financial relationships. Dr. Saag reported receiving grants and personal fees from Amgen, personal fees from Radius, and is a consultant for Amgen, Radius, Roche, and Daiichi Sankyo.

This article first appeared on Medscape.com.

Latest guidelines on the treatment of osteoporosis have been released that include new recommendations for the use of romosozumab (Evenity) in postmenopausal women with severe osteoporosis, but they contain caveats as to which women should – and should not – receive the drug.

The updated clinical practice guideline from the Endocrine Society is in response to the approval of romosozumab by the Food and Drug Administration (FDA) in April 2019, and more recently, by the European Medicines Agency.

It was published online February 18 in the Journal of Clinical Endocrinology & Metabolism.

In the new guidelines, committee members recommend the use of romosozumab for postmenopausal women with osteoporosis at very high risk of fracture. Candidates would include women with severe osteoporosis (T-score of less than –2.5 and a prior fracture) or women with a history of multiple vertebral fractures.

Women should be treated with romosozumab for up to 1 year, followed by an antiresorptive agent to maintain bone mineral density gains and further reduce fracture risk.

“The recommended dosage is 210 mg monthly by subcutaneous injection for 12 months,” the authors wrote.

However, and very importantly, romosozumab should not be considered for women at high risk of cardiovascular disease (CVD) or cerebrovascular disease. A high risk of CVD includes women who have had a previous myocardial infarction (MI) or stroke.

Experts questioned by Medscape Medical News stressed that romosozumab should not be a first-line, or even generally a second-line, option for osteoporosis, but it can be a considered for select patients with severe osteoporosis, taking into account CV risk.

Boxed warning

In the Active-Controlled Fracture Study in Postmenopausal Women With Osteoporosis at High Risk (ARCH), there were more major adverse cardiovascular events (MACE) in the first year of the trial with romosozumab, and patients had a 31% higher risk of MACE with romosozumab, compared with the bisphosphonate alendronate.

As a result, the drug was initially rejected by a number of regulatory agencies.

In the United States and Canada, it was eventually approved with a boxed warning, which cautions against the use of the drug in patients at risk for myocardial infarction, stroke, and CVD-related death.

“Romosozumab offers promising results for postmenopausal women with severe osteoporosis or who have a history of fractures,” Clifford Rosen, MD, Maine Medical Center Research Institute in Scarborough and chair of the writing committee, said in an Endocrine Society statement. “It does, however, come with a risk of heart disease, so clinicians need to be careful when selecting patients for this therapy.”

Exact risk unknown

Asked by Medscape Medical News to comment, Kenneth Saag, MD, professor of medicine, University of Alabama at Birmingham and principle investigator of the ARCH study, said that physicians needed more data from real-world studies to resolve the issue around whether romosozumab heightens the risk of CV events in women with osteoporosis or whether that particular finding from ARCH was an artifact.

“Women who have had a recent cardiovascular event should not receive the drug,” he said, agreeing with the new guidelines.

But it remains unclear, for example, whether women who are at slightly higher risk of having a CV event by virtue of their age alone, are also at risk, he noted.

In the meantime, results from the ARCH study clearly showed that not only was romosozumab more effective than alendronate, “but it is more effective than other bone-building drugs as well,” Dr. Saag observed, and it leads to a significantly greater reduction in vertebral, nonvertebral, and hip fractures, compared with the alendronate, the current standard of care in osteoporosis.

“In patients who have very severe osteoporosis and who have had a recent fracture or who are at risk for imminent future fracture, physicians need to balance the benefit versus the risk in favor of using romosozumab,” Dr. Saag suggested.

“And while I would say most women prefer not to inject themselves, the women I have put on this medicine have all had recent fractures and they are very aware of the pain and the disability of having a broken bone, so it is something they are willing to do,” he added.
 

Not for all women

Giving his opinion, Bart Clarke, MD, of the Mayo Clinic in Rochester, Minnesota, underscored the fact that the Fracture Study in Postmenopausal Women With Osteoporosis (FRAME), again conducted in postmenopausal women, showed no increase in CV events in patients treated with romosozumab compared with placebo.

“So there are questions about what this means, because if these events really were a drug effect, then that effect would be even more evident compared with placebo and they did not see any signal of CV events [in FRAME],” said Dr. Clarke, past president of the American Society of Bone and Mineral Research.

Like everything else in medicine, “there is always some risk,” Dr. Clarke observed.

However, what physicians should do is talk to women, ensure they have not had either an MI or stroke in the last year, and if patients have severe osteoporosis and a high risk of fracture, “then we can say, here’s another option,” he suggested.

“Then, if a woman develops chest pain or shortness of breath while on the drug, [she needs] to let us know ,and then we’ll stop the drug and reassess the situation,” he added.

Dr. Clarke also pointed out that if the FDA had received further reports of CV events linked to romosozumab, physicians would know about it by now, but to his knowledge, there has been no change to the drug’s current warning label.

Furthermore, neither he nor any of his colleagues who treat metabolic bone disease at the Mayo Clinic has seen a single CV event in patients prescribed the agent.

“This is not a drug we would use as first-line for most patients, and we don’t even use it as second-line for most patients, but in people who have not responded to other drugs or who have had terrible things happen to them already, hip fracture especially, then we are saying, you can consider this, he concluded.

The guidelines were supported by the Endocrine Society. Dr. Rosen and Dr. Clarke reported no relevant financial relationships. Dr. Saag reported receiving grants and personal fees from Amgen, personal fees from Radius, and is a consultant for Amgen, Radius, Roche, and Daiichi Sankyo.

This article first appeared on Medscape.com.

Vineet Chopra, MD, MSc, FHM, is associate professor of medicine and chief of the Division of Hospital Medicine at Michigan Medicine and the VA Ann Arbor (Michigan) Health System. A career hospitalist, Dr. Chopra’s research is dedicated to improving the safety of hospitalized patients through prevention of hospital-acquired complications. His work focuses on identifying and preventing complications associated with central venous catheters with a particular emphasis on peripherally inserted central catheters (PICCs).

Dr. Chopra is the recipient of numerous teaching and research awards including the 2016 Kaiser Permanente Award for Clinical Teaching, the Jerome W. Conn Award for Outstanding Research in the Department of Medicine, the 2016 Society of Hospital Medicine Award for Excellence in Research, and the 2014 McDevitt Award for Research Excellence. He has published over 100 peer-reviewed articles and has served as associate editor for the American Journal of Medicine and Journal of Hospital Medicine.
 

At what point in your education/training did you decide to practice hospital medicine? What about hospital medicine appealed to you?

I think I knew very early – toward the middle of my intern year – that I wanted to be a hospitalist. There was much that drew me to the field. First, I loved being in the inpatient setting. The tempo of work, the unexpected nature of what may come next, and the opportunity to truly have an impact on a patients life at their time of greatest need appealed to me. I wasn’t as inclined towards the procedural fields and also loved the cognitive aspects of general medicine – doing the work up on a difficult diagnosis or medically managing a patient with acute coronary syndrome came naturally. I found myself loving the work so much so that it didn’t feel like work. And the rest was history!

What is your current role at Michigan Medicine?

I started at Michigan Medicine in 2008 as a full-time clinician taking care of patients on direct care and resident services. After 3 years of clinical work, I decided it was time to hone in on a specific skill set and went back to a research fellowship.

I become Michigan’s first fellow in hospital medicine – the guinea pig – for what would turn out to be one of the best decisions in my life. After finishing fellowship, I switched my focus from clinical work to research and rose up the ranks to receive tenure as an associate professor of medicine. After attaining tenure, I was among a handful of people in the nation who had success in both the research and the clinical arenas and leadership opportunities began to come my way.

I was fortunate to be recruited as the inaugural division chief of hospital medicine at Michigan Medicine in 2017. The Division of hospital medicine is the 13th in the department of medicine and the first one to be created in over 60 years. As division chief, I oversee all of our clinical, academic, research, and educational endeavors. Currently, we have approximately 130 hospitalists in our group and about 30 advanced practice providers (APPs) with a support and research staff of about 15 individuals. So I like to say we have a big family!
 

What are your favorite areas of clinical practice and/or research?

I am fortunate to have the ability to enjoy all that hospital medicine has to offer. I still appreciate the challenges that direct care brings, and I continue to do as much as I can in this area. I also enjoy working with residents and medical students at the university and at our VA site – where much of my focus is devoted to making sure all learners on the team are growing while they provide excellent patient care. To meet a new patient and work to develop a therapeutic relationship with them such that we can make positive changes in their disease trajectory remains my favorite part of clinical work.

My research work remains closely linked to my clinical interests around preventing patient harm and improving patient safety – so studying hospital-acquired infections, coming up with new ideas and strategies, and then implementing them when on clinical service represents the perfect blend of the two. My research is largely focused on intravenous devices and catheters, and I focus my work on preventing harms such as bloodstream infection, venous thrombosis, and related adverse events. I have been fortunate to receive national and international attention for my research, including adoption of my work into guidelines and changes to national policies. I am honored to serve on the most important federal advisory committee that advises the government on health care infections (the committee is called HICPAC – Healthcare Infection Control Practice Advisory Committee).
 

What are the most challenging aspects of practicing hospital medicine? What are the most rewarding?

For me, the most challenging aspects are also the most rewarding. First and foremost, making a connection with a patient and their family to understand their concerns and define a therapeutic alliance is both challenging and rewarding. Second, ensuring that we have the ability to work efficiently and effectively to manage patient care is sometimes challenging but also the most rewarding aspect of the job. I am fortunate to work in a health system where I am surrounded by smart colleagues, important resources, advanced technology, and the support of nurses and advanced practice providers who share this zeal of patient care with me.

Finally, one the greatest challenges and rewards remains time. Our work is hard and grueling, and it is often very challenging to get things done at different times of the day. But the ability to make a diagnosis or see a patient improve makes it all worth it!
 

How will hospital medicine change in the next decade or two?

I predict our work will shift from a model that is reactive – taking care of patients that are sick and need hospitalization – to a proactive approach where the focus will remain on keeping people out of the hospital. This doesn’t necessarily mean that we will be out of a job – but I see the model of our work shifting to ensure that patients who are discharged remain healthy and well. This means we will need to embrace extensivist models, hospital at home care, and aspects such as bridge clinics.

I also think our work will evolve to harness some of the incredible technology that surrounds us outside health care, but has not yet permeated our work flow. To that end, aspects such as virtual consultations and patient assessments, and remote monitoring that includes biometrics, will all fall into our workflow. And of course, lets not forget about the mighty electronic medical record and how that will affect our experience and work. I see much more of our work shifting toward becoming digital experts, harnessing the power of big data and predictive analytics to provide better care for patients. These are skills that are emerging in our field, but we have not yet mastered the art of managing data.
 

Do you have any advice for students and residents interested in hospital medicine?

I would highly recommend taking on a rotation with a hospitalist, carrying the pager and working side-by-side with someone who truly loves what they do. Many students and residents just see the on/off nature of the work, but that is truly skin deep in terms of attraction.

The beauty of hospital medicine is that you can be everything for a patient – their doctor, their health care navigator, their friend, and their partner during their hospital stay. Find that joy – you will not regret it!

Vineet Chopra, MD, MSc, FHM, is associate professor of medicine and chief of the Division of Hospital Medicine at Michigan Medicine and the VA Ann Arbor (Michigan) Health System. A career hospitalist, Dr. Chopra’s research is dedicated to improving the safety of hospitalized patients through prevention of hospital-acquired complications. His work focuses on identifying and preventing complications associated with central venous catheters with a particular emphasis on peripherally inserted central catheters (PICCs).

Dr. Chopra is the recipient of numerous teaching and research awards including the 2016 Kaiser Permanente Award for Clinical Teaching, the Jerome W. Conn Award for Outstanding Research in the Department of Medicine, the 2016 Society of Hospital Medicine Award for Excellence in Research, and the 2014 McDevitt Award for Research Excellence. He has published over 100 peer-reviewed articles and has served as associate editor for the American Journal of Medicine and Journal of Hospital Medicine.
 

At what point in your education/training did you decide to practice hospital medicine? What about hospital medicine appealed to you?

I think I knew very early – toward the middle of my intern year – that I wanted to be a hospitalist. There was much that drew me to the field. First, I loved being in the inpatient setting. The tempo of work, the unexpected nature of what may come next, and the opportunity to truly have an impact on a patients life at their time of greatest need appealed to me. I wasn’t as inclined towards the procedural fields and also loved the cognitive aspects of general medicine – doing the work up on a difficult diagnosis or medically managing a patient with acute coronary syndrome came naturally. I found myself loving the work so much so that it didn’t feel like work. And the rest was history!

What is your current role at Michigan Medicine?

I started at Michigan Medicine in 2008 as a full-time clinician taking care of patients on direct care and resident services. After 3 years of clinical work, I decided it was time to hone in on a specific skill set and went back to a research fellowship.

I become Michigan’s first fellow in hospital medicine – the guinea pig – for what would turn out to be one of the best decisions in my life. After finishing fellowship, I switched my focus from clinical work to research and rose up the ranks to receive tenure as an associate professor of medicine. After attaining tenure, I was among a handful of people in the nation who had success in both the research and the clinical arenas and leadership opportunities began to come my way.

I was fortunate to be recruited as the inaugural division chief of hospital medicine at Michigan Medicine in 2017. The Division of hospital medicine is the 13th in the department of medicine and the first one to be created in over 60 years. As division chief, I oversee all of our clinical, academic, research, and educational endeavors. Currently, we have approximately 130 hospitalists in our group and about 30 advanced practice providers (APPs) with a support and research staff of about 15 individuals. So I like to say we have a big family!
 

What are your favorite areas of clinical practice and/or research?

I am fortunate to have the ability to enjoy all that hospital medicine has to offer. I still appreciate the challenges that direct care brings, and I continue to do as much as I can in this area. I also enjoy working with residents and medical students at the university and at our VA site – where much of my focus is devoted to making sure all learners on the team are growing while they provide excellent patient care. To meet a new patient and work to develop a therapeutic relationship with them such that we can make positive changes in their disease trajectory remains my favorite part of clinical work.

My research work remains closely linked to my clinical interests around preventing patient harm and improving patient safety – so studying hospital-acquired infections, coming up with new ideas and strategies, and then implementing them when on clinical service represents the perfect blend of the two. My research is largely focused on intravenous devices and catheters, and I focus my work on preventing harms such as bloodstream infection, venous thrombosis, and related adverse events. I have been fortunate to receive national and international attention for my research, including adoption of my work into guidelines and changes to national policies. I am honored to serve on the most important federal advisory committee that advises the government on health care infections (the committee is called HICPAC – Healthcare Infection Control Practice Advisory Committee).
 

What are the most challenging aspects of practicing hospital medicine? What are the most rewarding?

For me, the most challenging aspects are also the most rewarding. First and foremost, making a connection with a patient and their family to understand their concerns and define a therapeutic alliance is both challenging and rewarding. Second, ensuring that we have the ability to work efficiently and effectively to manage patient care is sometimes challenging but also the most rewarding aspect of the job. I am fortunate to work in a health system where I am surrounded by smart colleagues, important resources, advanced technology, and the support of nurses and advanced practice providers who share this zeal of patient care with me.

Finally, one the greatest challenges and rewards remains time. Our work is hard and grueling, and it is often very challenging to get things done at different times of the day. But the ability to make a diagnosis or see a patient improve makes it all worth it!
 

How will hospital medicine change in the next decade or two?

I predict our work will shift from a model that is reactive – taking care of patients that are sick and need hospitalization – to a proactive approach where the focus will remain on keeping people out of the hospital. This doesn’t necessarily mean that we will be out of a job – but I see the model of our work shifting to ensure that patients who are discharged remain healthy and well. This means we will need to embrace extensivist models, hospital at home care, and aspects such as bridge clinics.

I also think our work will evolve to harness some of the incredible technology that surrounds us outside health care, but has not yet permeated our work flow. To that end, aspects such as virtual consultations and patient assessments, and remote monitoring that includes biometrics, will all fall into our workflow. And of course, lets not forget about the mighty electronic medical record and how that will affect our experience and work. I see much more of our work shifting toward becoming digital experts, harnessing the power of big data and predictive analytics to provide better care for patients. These are skills that are emerging in our field, but we have not yet mastered the art of managing data.
 

Do you have any advice for students and residents interested in hospital medicine?

I would highly recommend taking on a rotation with a hospitalist, carrying the pager and working side-by-side with someone who truly loves what they do. Many students and residents just see the on/off nature of the work, but that is truly skin deep in terms of attraction.

The beauty of hospital medicine is that you can be everything for a patient – their doctor, their health care navigator, their friend, and their partner during their hospital stay. Find that joy – you will not regret it!

Vineet Chopra, MD, MSc, FHM, is associate professor of medicine and chief of the Division of Hospital Medicine at Michigan Medicine and the VA Ann Arbor (Michigan) Health System. A career hospitalist, Dr. Chopra’s research is dedicated to improving the safety of hospitalized patients through prevention of hospital-acquired complications. His work focuses on identifying and preventing complications associated with central venous catheters with a particular emphasis on peripherally inserted central catheters (PICCs).

Dr. Chopra is the recipient of numerous teaching and research awards including the 2016 Kaiser Permanente Award for Clinical Teaching, the Jerome W. Conn Award for Outstanding Research in the Department of Medicine, the 2016 Society of Hospital Medicine Award for Excellence in Research, and the 2014 McDevitt Award for Research Excellence. He has published over 100 peer-reviewed articles and has served as associate editor for the American Journal of Medicine and Journal of Hospital Medicine.
 

At what point in your education/training did you decide to practice hospital medicine? What about hospital medicine appealed to you?

I think I knew very early – toward the middle of my intern year – that I wanted to be a hospitalist. There was much that drew me to the field. First, I loved being in the inpatient setting. The tempo of work, the unexpected nature of what may come next, and the opportunity to truly have an impact on a patients life at their time of greatest need appealed to me. I wasn’t as inclined towards the procedural fields and also loved the cognitive aspects of general medicine – doing the work up on a difficult diagnosis or medically managing a patient with acute coronary syndrome came naturally. I found myself loving the work so much so that it didn’t feel like work. And the rest was history!

What is your current role at Michigan Medicine?

I started at Michigan Medicine in 2008 as a full-time clinician taking care of patients on direct care and resident services. After 3 years of clinical work, I decided it was time to hone in on a specific skill set and went back to a research fellowship.

I become Michigan’s first fellow in hospital medicine – the guinea pig – for what would turn out to be one of the best decisions in my life. After finishing fellowship, I switched my focus from clinical work to research and rose up the ranks to receive tenure as an associate professor of medicine. After attaining tenure, I was among a handful of people in the nation who had success in both the research and the clinical arenas and leadership opportunities began to come my way.

I was fortunate to be recruited as the inaugural division chief of hospital medicine at Michigan Medicine in 2017. The Division of hospital medicine is the 13th in the department of medicine and the first one to be created in over 60 years. As division chief, I oversee all of our clinical, academic, research, and educational endeavors. Currently, we have approximately 130 hospitalists in our group and about 30 advanced practice providers (APPs) with a support and research staff of about 15 individuals. So I like to say we have a big family!
 

What are your favorite areas of clinical practice and/or research?

I am fortunate to have the ability to enjoy all that hospital medicine has to offer. I still appreciate the challenges that direct care brings, and I continue to do as much as I can in this area. I also enjoy working with residents and medical students at the university and at our VA site – where much of my focus is devoted to making sure all learners on the team are growing while they provide excellent patient care. To meet a new patient and work to develop a therapeutic relationship with them such that we can make positive changes in their disease trajectory remains my favorite part of clinical work.

My research work remains closely linked to my clinical interests around preventing patient harm and improving patient safety – so studying hospital-acquired infections, coming up with new ideas and strategies, and then implementing them when on clinical service represents the perfect blend of the two. My research is largely focused on intravenous devices and catheters, and I focus my work on preventing harms such as bloodstream infection, venous thrombosis, and related adverse events. I have been fortunate to receive national and international attention for my research, including adoption of my work into guidelines and changes to national policies. I am honored to serve on the most important federal advisory committee that advises the government on health care infections (the committee is called HICPAC – Healthcare Infection Control Practice Advisory Committee).
 

What are the most challenging aspects of practicing hospital medicine? What are the most rewarding?

For me, the most challenging aspects are also the most rewarding. First and foremost, making a connection with a patient and their family to understand their concerns and define a therapeutic alliance is both challenging and rewarding. Second, ensuring that we have the ability to work efficiently and effectively to manage patient care is sometimes challenging but also the most rewarding aspect of the job. I am fortunate to work in a health system where I am surrounded by smart colleagues, important resources, advanced technology, and the support of nurses and advanced practice providers who share this zeal of patient care with me.

Finally, one the greatest challenges and rewards remains time. Our work is hard and grueling, and it is often very challenging to get things done at different times of the day. But the ability to make a diagnosis or see a patient improve makes it all worth it!
 

How will hospital medicine change in the next decade or two?

I predict our work will shift from a model that is reactive – taking care of patients that are sick and need hospitalization – to a proactive approach where the focus will remain on keeping people out of the hospital. This doesn’t necessarily mean that we will be out of a job – but I see the model of our work shifting to ensure that patients who are discharged remain healthy and well. This means we will need to embrace extensivist models, hospital at home care, and aspects such as bridge clinics.

I also think our work will evolve to harness some of the incredible technology that surrounds us outside health care, but has not yet permeated our work flow. To that end, aspects such as virtual consultations and patient assessments, and remote monitoring that includes biometrics, will all fall into our workflow. And of course, lets not forget about the mighty electronic medical record and how that will affect our experience and work. I see much more of our work shifting toward becoming digital experts, harnessing the power of big data and predictive analytics to provide better care for patients. These are skills that are emerging in our field, but we have not yet mastered the art of managing data.
 

Do you have any advice for students and residents interested in hospital medicine?

I would highly recommend taking on a rotation with a hospitalist, carrying the pager and working side-by-side with someone who truly loves what they do. Many students and residents just see the on/off nature of the work, but that is truly skin deep in terms of attraction.

The beauty of hospital medicine is that you can be everything for a patient – their doctor, their health care navigator, their friend, and their partner during their hospital stay. Find that joy – you will not regret it!

New research suggests the incidence of death from unintentional injury is higher among patients with cancer than among those in the general U.S. population.

The findings highlight the need for more initiatives to help recognize patients at risk of death from this category of injury, which is the third leading cause of death in the country, according to the study authors.

“The purpose of our study was to present a comprehensive analysis of death from unintentional injury among patients with cancer using a large population-based cohort,” wrote Kunyu Yang, MD, of Huazhong University of Science and Technology in China, and colleagues. Their report is in JAMA Network Open.

The retrospective study included 8,271,020 patients with cancer, 40,599 of whom died from unintentional injury. The researchers identified patients who received a new diagnosis of primary cancer between Jan. 1, 1973, and Dec. 31, 2015, from the Surveillance, Epidemiology, and End Results (SEER) database.

The mean age of study participants was 63.0 years, and most were diagnosed in the 2000-2009 period (41.6%) or the 2010-2015 period (27.6%).

The SEER data was compared with mortality data representative of the general U.S. population obtained from the National Center for Health Statistics. Standardized mortality ratios and rates of death from unintentional injury were measured in both groups.

The rates of death from unintentional injury were 81.90 per 100,000 person-years in cancer patients and 51.21 per 100,000 person-years in the general population. The standardized mortality ratio was 1.60 (95% confidence interval, 1.58-1.61).

Factors associated with higher rates of death from unintentional injury among cancer patients included male sex (relative risk, 1.69; P less than .001), age greater than 80 years at diagnosis (RR, 2.91; P less than .001), and being unmarried (RR, 1.23; P less than .001).

“Rates of death from unintentional injury were the highest in patients with cancers of the liver (200.37 per 100,000 person-years), brain (175.04 per 100,000 person-years), larynx (148.78 per 100,000 person-years), and esophagus (144.98 per 100,000 person-years),” the researchers reported.

They acknowledged that a key limitation of this study was the potential role of reporting bias in death certificate analyses. As a result, death due to unintentional injury and death from suicide and homicide could have been misclassified.

“Cancer-related suicides, like all suicides, are preventable and should be viewed as cancer-related mortality. It is a silent killer with a peak incidence weeks after diagnosis – an undeniably hectic time for most patients and clinicians getting to know their patients,” said Daniel C. McFarland, DO, of Memorial Sloan Kettering Cancer Center in New York. He was not involved in this study.

“Suicide screening with appropriate systems in place to address suicidal thoughts and behavior is crucial for cancer patients throughout the trajectory of their care,” he added.

As with death from unintentional injury, higher rates of suicide have been reported among cancer patients in comparison to the general population (Nat Commun. 2019;10[1]:207).

No funding sources were reported for this study. The authors and Dr. McFarland disclosed no conflicts of interest.

SOURCE: Yang K et al. JAMA Netw Open. 2020 Feb 21. doi: 10.1001/jamanetworkopen.2019.21647.

New research suggests the incidence of death from unintentional injury is higher among patients with cancer than among those in the general U.S. population.

The findings highlight the need for more initiatives to help recognize patients at risk of death from this category of injury, which is the third leading cause of death in the country, according to the study authors.

“The purpose of our study was to present a comprehensive analysis of death from unintentional injury among patients with cancer using a large population-based cohort,” wrote Kunyu Yang, MD, of Huazhong University of Science and Technology in China, and colleagues. Their report is in JAMA Network Open.

The retrospective study included 8,271,020 patients with cancer, 40,599 of whom died from unintentional injury. The researchers identified patients who received a new diagnosis of primary cancer between Jan. 1, 1973, and Dec. 31, 2015, from the Surveillance, Epidemiology, and End Results (SEER) database.

The mean age of study participants was 63.0 years, and most were diagnosed in the 2000-2009 period (41.6%) or the 2010-2015 period (27.6%).

The SEER data was compared with mortality data representative of the general U.S. population obtained from the National Center for Health Statistics. Standardized mortality ratios and rates of death from unintentional injury were measured in both groups.

The rates of death from unintentional injury were 81.90 per 100,000 person-years in cancer patients and 51.21 per 100,000 person-years in the general population. The standardized mortality ratio was 1.60 (95% confidence interval, 1.58-1.61).

Factors associated with higher rates of death from unintentional injury among cancer patients included male sex (relative risk, 1.69; P less than .001), age greater than 80 years at diagnosis (RR, 2.91; P less than .001), and being unmarried (RR, 1.23; P less than .001).

“Rates of death from unintentional injury were the highest in patients with cancers of the liver (200.37 per 100,000 person-years), brain (175.04 per 100,000 person-years), larynx (148.78 per 100,000 person-years), and esophagus (144.98 per 100,000 person-years),” the researchers reported.

They acknowledged that a key limitation of this study was the potential role of reporting bias in death certificate analyses. As a result, death due to unintentional injury and death from suicide and homicide could have been misclassified.

“Cancer-related suicides, like all suicides, are preventable and should be viewed as cancer-related mortality. It is a silent killer with a peak incidence weeks after diagnosis – an undeniably hectic time for most patients and clinicians getting to know their patients,” said Daniel C. McFarland, DO, of Memorial Sloan Kettering Cancer Center in New York. He was not involved in this study.

“Suicide screening with appropriate systems in place to address suicidal thoughts and behavior is crucial for cancer patients throughout the trajectory of their care,” he added.

As with death from unintentional injury, higher rates of suicide have been reported among cancer patients in comparison to the general population (Nat Commun. 2019;10[1]:207).

No funding sources were reported for this study. The authors and Dr. McFarland disclosed no conflicts of interest.

SOURCE: Yang K et al. JAMA Netw Open. 2020 Feb 21. doi: 10.1001/jamanetworkopen.2019.21647.

New research suggests the incidence of death from unintentional injury is higher among patients with cancer than among those in the general U.S. population.

The findings highlight the need for more initiatives to help recognize patients at risk of death from this category of injury, which is the third leading cause of death in the country, according to the study authors.

“The purpose of our study was to present a comprehensive analysis of death from unintentional injury among patients with cancer using a large population-based cohort,” wrote Kunyu Yang, MD, of Huazhong University of Science and Technology in China, and colleagues. Their report is in JAMA Network Open.

The retrospective study included 8,271,020 patients with cancer, 40,599 of whom died from unintentional injury. The researchers identified patients who received a new diagnosis of primary cancer between Jan. 1, 1973, and Dec. 31, 2015, from the Surveillance, Epidemiology, and End Results (SEER) database.

The mean age of study participants was 63.0 years, and most were diagnosed in the 2000-2009 period (41.6%) or the 2010-2015 period (27.6%).

The SEER data was compared with mortality data representative of the general U.S. population obtained from the National Center for Health Statistics. Standardized mortality ratios and rates of death from unintentional injury were measured in both groups.

The rates of death from unintentional injury were 81.90 per 100,000 person-years in cancer patients and 51.21 per 100,000 person-years in the general population. The standardized mortality ratio was 1.60 (95% confidence interval, 1.58-1.61).

Factors associated with higher rates of death from unintentional injury among cancer patients included male sex (relative risk, 1.69; P less than .001), age greater than 80 years at diagnosis (RR, 2.91; P less than .001), and being unmarried (RR, 1.23; P less than .001).

“Rates of death from unintentional injury were the highest in patients with cancers of the liver (200.37 per 100,000 person-years), brain (175.04 per 100,000 person-years), larynx (148.78 per 100,000 person-years), and esophagus (144.98 per 100,000 person-years),” the researchers reported.

They acknowledged that a key limitation of this study was the potential role of reporting bias in death certificate analyses. As a result, death due to unintentional injury and death from suicide and homicide could have been misclassified.

“Cancer-related suicides, like all suicides, are preventable and should be viewed as cancer-related mortality. It is a silent killer with a peak incidence weeks after diagnosis – an undeniably hectic time for most patients and clinicians getting to know their patients,” said Daniel C. McFarland, DO, of Memorial Sloan Kettering Cancer Center in New York. He was not involved in this study.

“Suicide screening with appropriate systems in place to address suicidal thoughts and behavior is crucial for cancer patients throughout the trajectory of their care,” he added.

As with death from unintentional injury, higher rates of suicide have been reported among cancer patients in comparison to the general population (Nat Commun. 2019;10[1]:207).

No funding sources were reported for this study. The authors and Dr. McFarland disclosed no conflicts of interest.

SOURCE: Yang K et al. JAMA Netw Open. 2020 Feb 21. doi: 10.1001/jamanetworkopen.2019.21647.

WEST PALM BEACH, FLA. – Women who have no history of a full-term pregnancy show an earlier onset of progressive multiple sclerosis (MS) compared to those who do have pregnancies, and the apparent onset-delaying effect appears to increase with the number of pregnancies, according to new research adding to speculation of the effects of pregnancy in MS.

“Our results suggest that a higher number of full-term pregnancies than average is associated with later onset of progressive MS, while having no full-term pregnancies is associated with significantly younger age at progressive MS onset,” first author Burcu Zeydan, MD, an assistant professor of radiology in the Center of MS and Autoimmune Neurology at the Mayo Clinic in Rochester, Minn., said in an interview.

The study was presented at the meeting held by the Americas Committee for Treatment and Research in Multiple Sclerosis (ACTRIMS).

The findings, which also link early menopause with faster disease progression, offer important insights into the broader effects of pregnancy on MS, said ACTRIMS president Jeffrey A. Cohen, MD, director of Experimental Therapeutics at the Mellen Center for MS Treatment and Research at the Cleveland Clinic.

“We know pregnancy affects the short term disease activity – relapses tend to quiet down during pregnancy – but what has been somewhat conflicting is whether it affects the long-term prognosis or is just a temporary effect,” he said in an interview.

“So that is the main interest in this study, and it does indicate that pregnancy affects the long-term prognosis and provides some insight into the mechanism by which it might do that.”

While being female is in fact considered the most important risk factor for MS susceptibility, pregnancy has been suggested to have a protective role in disease progression, but more research is needed on the nature of the effect – and its mechanisms.

For the study, Dr. Zeydan and colleagues evaluated data on 202 patients with MS who were part of a Mayo Clinic survey, including 134 women and 68 men.

They found that women who had no full-term pregnancies (n = 32), had an earlier onset of progressive MS (mean age 41.4 ± 12.6 years) compared to women giving birth to 1 or more children (n = 95; 47.1 ± 9.7 years; P = .012).

In addition, the mean age of progressive MS onset also increased with a dose-effect trend according to number of full pregnancies (no children, 41.4 ± 12.6 years; 1-3 children: 46.4 ± 9.2 years; 4 or more children: 52.6 ± 12.9 years; P = .002).

A look at a subgroup of patients with secondary progressive MS also showed an earlier mean age of onset among women who had no full pregnancies (n = 19; 41.5 ± 9.2 years) compared to women with 1 or more full pregnancies (n = 57; 47.3 ± 10.6 years; P = .049).

The later disease onset associated with pregnancy was also seen in relapsing-remitting MS: Mean age of onset was earlier women with no pregnancies (27.5 ± 7.0 years) compared to those with one or more children (33.0 ± 9.4 years; P = .021).

The trends of later onset with more pregnancies was also observed with the mean age of onset of secondary progressive MS (no full pregnancies: onset at 41.5 ± 9.2 years; 1-3 pregnancies: 46.2 ± 9.9 years; 4 or more pregnancies, onset 52.6 ± 12.9 years; P = .010).

And likewise, the later mean age of onset of relapsing-remitting MS was seen with additional pregnancies (no full pregnancies: 27.5 ± 7.0 years; 1-3 pregnancies: 32.4 ± 9.3 years; 4 or more pregnancies: 35.8 ± 9.8 years; P = .012).

“The dose effect was clearly a surprise (having no full-term pregnancies vs. 1-3 vs. 4 or more),” Dr. Zeydan said.

“In addition to the significant difference between having no versus one or more full-term pregnancies, the clear dose-effect consolidates our results related to the association between the number of pregnancies and age at progressive MS onset.”

Early menopause also linked to shorter progression to secondary progressive MS

The study also showed that women with premature or early menopause had a shorter duration of progressing from relapsing-remitting MS to secondary progressive MS (n = 26; 12.9 ± 9.0 years) compared to women with normal age at menopause (n = 39; 17.8 ± 10.3 years).

The pattern was similar for women experiencing the onset of secondary progressive MS after menopause, with a shorter progression among those with early menopause (P = .012).

The patterns in early menopause are consistent with previous observations regarding menopause and MS progression, Dr. Cohen said.

“When women go through menopause, estradiol and pregnancy-related factors further decline and we know this coincides temporally with the development of progressive MS in women,” he noted.

Compared to men, women with premature or early menopause furthermore had a longer duration from relapsing-remitting MS to secondary progressive MS (P = .008), and women with secondary progressive MS also had also had an earlier age of relapsing-remitting MS onset than men (P = .018).

Possible mechanisms and applications of the findings

The mechanisms of pregnancy that could include a complex interaction between estrogen and factors such as astrocyte and microglia function, Dr. Zeydan explained.

“Estrogen, through various mechanisms of eliminating toxicity of highly activated neurons – including preventing proinflammatory molecule release, supporting mitochondria function thereby eliminating energy failure, and promoting remyelination – helps neuronal plasticity and delays neurodegeneration, which is closely related to the progressive phase of MS,” she said.

“One could easily make the probable association, while yet to be proven, that our findings may relate to these mechanisms,” Dr. Zeydan said.

The logical question of whether hormone replacement or some type of therapy that could mimic the effects of pregnancy could also benefit in delaying MS onset remained to be seen, Dr. Zeydan said.

“While we believe that is possible, particularly for delaying the onset of progressive phase, definitive evidence is lacking at this time,” Dr. Zeydan said.

“However, our study ultimately may lead to such a trial.”

In the meantime, the findings provide additional insights that may be beneficial in sharing with patients regarding pregnancy,” she said.

“As the contemporary problem in MS care is to delay or prevent progressive MS onset, our findings may suggest that how we counsel women with MS who are planning to get pregnant, or contemplating surgically induced menopause, or how we consider hormone therapies during perimenopause may impact the course of their disease.”

Dr. Zeydan cautioned, however, that “our findings do not confirm causality beyond an association.”

“More studies are needed in this important issue in a disease that affects women three times more than men.”

Dr. Zeydan had no disclosures to report. Dr. Cohen reported receiving personal compensation for consulting for Adamas, Convelo, MedDay, Mylan, and Population Council; and serving as an Editor of Multiple Sclerosis Journal.

SOURCE: Zeydan B et al. ACTRIMS Forum 2020, Abstract P135.

WEST PALM BEACH, FLA. – Women who have no history of a full-term pregnancy show an earlier onset of progressive multiple sclerosis (MS) compared to those who do have pregnancies, and the apparent onset-delaying effect appears to increase with the number of pregnancies, according to new research adding to speculation of the effects of pregnancy in MS.

“Our results suggest that a higher number of full-term pregnancies than average is associated with later onset of progressive MS, while having no full-term pregnancies is associated with significantly younger age at progressive MS onset,” first author Burcu Zeydan, MD, an assistant professor of radiology in the Center of MS and Autoimmune Neurology at the Mayo Clinic in Rochester, Minn., said in an interview.

The study was presented at the meeting held by the Americas Committee for Treatment and Research in Multiple Sclerosis (ACTRIMS).

The findings, which also link early menopause with faster disease progression, offer important insights into the broader effects of pregnancy on MS, said ACTRIMS president Jeffrey A. Cohen, MD, director of Experimental Therapeutics at the Mellen Center for MS Treatment and Research at the Cleveland Clinic.

“We know pregnancy affects the short term disease activity – relapses tend to quiet down during pregnancy – but what has been somewhat conflicting is whether it affects the long-term prognosis or is just a temporary effect,” he said in an interview.

“So that is the main interest in this study, and it does indicate that pregnancy affects the long-term prognosis and provides some insight into the mechanism by which it might do that.”

While being female is in fact considered the most important risk factor for MS susceptibility, pregnancy has been suggested to have a protective role in disease progression, but more research is needed on the nature of the effect – and its mechanisms.

For the study, Dr. Zeydan and colleagues evaluated data on 202 patients with MS who were part of a Mayo Clinic survey, including 134 women and 68 men.

They found that women who had no full-term pregnancies (n = 32), had an earlier onset of progressive MS (mean age 41.4 ± 12.6 years) compared to women giving birth to 1 or more children (n = 95; 47.1 ± 9.7 years; P = .012).

In addition, the mean age of progressive MS onset also increased with a dose-effect trend according to number of full pregnancies (no children, 41.4 ± 12.6 years; 1-3 children: 46.4 ± 9.2 years; 4 or more children: 52.6 ± 12.9 years; P = .002).

A look at a subgroup of patients with secondary progressive MS also showed an earlier mean age of onset among women who had no full pregnancies (n = 19; 41.5 ± 9.2 years) compared to women with 1 or more full pregnancies (n = 57; 47.3 ± 10.6 years; P = .049).

The later disease onset associated with pregnancy was also seen in relapsing-remitting MS: Mean age of onset was earlier women with no pregnancies (27.5 ± 7.0 years) compared to those with one or more children (33.0 ± 9.4 years; P = .021).

The trends of later onset with more pregnancies was also observed with the mean age of onset of secondary progressive MS (no full pregnancies: onset at 41.5 ± 9.2 years; 1-3 pregnancies: 46.2 ± 9.9 years; 4 or more pregnancies, onset 52.6 ± 12.9 years; P = .010).

And likewise, the later mean age of onset of relapsing-remitting MS was seen with additional pregnancies (no full pregnancies: 27.5 ± 7.0 years; 1-3 pregnancies: 32.4 ± 9.3 years; 4 or more pregnancies: 35.8 ± 9.8 years; P = .012).

“The dose effect was clearly a surprise (having no full-term pregnancies vs. 1-3 vs. 4 or more),” Dr. Zeydan said.

“In addition to the significant difference between having no versus one or more full-term pregnancies, the clear dose-effect consolidates our results related to the association between the number of pregnancies and age at progressive MS onset.”

Early menopause also linked to shorter progression to secondary progressive MS

The study also showed that women with premature or early menopause had a shorter duration of progressing from relapsing-remitting MS to secondary progressive MS (n = 26; 12.9 ± 9.0 years) compared to women with normal age at menopause (n = 39; 17.8 ± 10.3 years).

The pattern was similar for women experiencing the onset of secondary progressive MS after menopause, with a shorter progression among those with early menopause (P = .012).

The patterns in early menopause are consistent with previous observations regarding menopause and MS progression, Dr. Cohen said.

“When women go through menopause, estradiol and pregnancy-related factors further decline and we know this coincides temporally with the development of progressive MS in women,” he noted.

Compared to men, women with premature or early menopause furthermore had a longer duration from relapsing-remitting MS to secondary progressive MS (P = .008), and women with secondary progressive MS also had also had an earlier age of relapsing-remitting MS onset than men (P = .018).

Possible mechanisms and applications of the findings

The mechanisms of pregnancy that could include a complex interaction between estrogen and factors such as astrocyte and microglia function, Dr. Zeydan explained.

“Estrogen, through various mechanisms of eliminating toxicity of highly activated neurons – including preventing proinflammatory molecule release, supporting mitochondria function thereby eliminating energy failure, and promoting remyelination – helps neuronal plasticity and delays neurodegeneration, which is closely related to the progressive phase of MS,” she said.

“One could easily make the probable association, while yet to be proven, that our findings may relate to these mechanisms,” Dr. Zeydan said.

The logical question of whether hormone replacement or some type of therapy that could mimic the effects of pregnancy could also benefit in delaying MS onset remained to be seen, Dr. Zeydan said.

“While we believe that is possible, particularly for delaying the onset of progressive phase, definitive evidence is lacking at this time,” Dr. Zeydan said.

“However, our study ultimately may lead to such a trial.”

In the meantime, the findings provide additional insights that may be beneficial in sharing with patients regarding pregnancy,” she said.

“As the contemporary problem in MS care is to delay or prevent progressive MS onset, our findings may suggest that how we counsel women with MS who are planning to get pregnant, or contemplating surgically induced menopause, or how we consider hormone therapies during perimenopause may impact the course of their disease.”

Dr. Zeydan cautioned, however, that “our findings do not confirm causality beyond an association.”

“More studies are needed in this important issue in a disease that affects women three times more than men.”

Dr. Zeydan had no disclosures to report. Dr. Cohen reported receiving personal compensation for consulting for Adamas, Convelo, MedDay, Mylan, and Population Council; and serving as an Editor of Multiple Sclerosis Journal.

SOURCE: Zeydan B et al. ACTRIMS Forum 2020, Abstract P135.

WEST PALM BEACH, FLA. – Women who have no history of a full-term pregnancy show an earlier onset of progressive multiple sclerosis (MS) compared to those who do have pregnancies, and the apparent onset-delaying effect appears to increase with the number of pregnancies, according to new research adding to speculation of the effects of pregnancy in MS.

“Our results suggest that a higher number of full-term pregnancies than average is associated with later onset of progressive MS, while having no full-term pregnancies is associated with significantly younger age at progressive MS onset,” first author Burcu Zeydan, MD, an assistant professor of radiology in the Center of MS and Autoimmune Neurology at the Mayo Clinic in Rochester, Minn., said in an interview.

The study was presented at the meeting held by the Americas Committee for Treatment and Research in Multiple Sclerosis (ACTRIMS).

The findings, which also link early menopause with faster disease progression, offer important insights into the broader effects of pregnancy on MS, said ACTRIMS president Jeffrey A. Cohen, MD, director of Experimental Therapeutics at the Mellen Center for MS Treatment and Research at the Cleveland Clinic.

“We know pregnancy affects the short term disease activity – relapses tend to quiet down during pregnancy – but what has been somewhat conflicting is whether it affects the long-term prognosis or is just a temporary effect,” he said in an interview.

“So that is the main interest in this study, and it does indicate that pregnancy affects the long-term prognosis and provides some insight into the mechanism by which it might do that.”

While being female is in fact considered the most important risk factor for MS susceptibility, pregnancy has been suggested to have a protective role in disease progression, but more research is needed on the nature of the effect – and its mechanisms.

For the study, Dr. Zeydan and colleagues evaluated data on 202 patients with MS who were part of a Mayo Clinic survey, including 134 women and 68 men.

They found that women who had no full-term pregnancies (n = 32), had an earlier onset of progressive MS (mean age 41.4 ± 12.6 years) compared to women giving birth to 1 or more children (n = 95; 47.1 ± 9.7 years; P = .012).

In addition, the mean age of progressive MS onset also increased with a dose-effect trend according to number of full pregnancies (no children, 41.4 ± 12.6 years; 1-3 children: 46.4 ± 9.2 years; 4 or more children: 52.6 ± 12.9 years; P = .002).

A look at a subgroup of patients with secondary progressive MS also showed an earlier mean age of onset among women who had no full pregnancies (n = 19; 41.5 ± 9.2 years) compared to women with 1 or more full pregnancies (n = 57; 47.3 ± 10.6 years; P = .049).

The later disease onset associated with pregnancy was also seen in relapsing-remitting MS: Mean age of onset was earlier women with no pregnancies (27.5 ± 7.0 years) compared to those with one or more children (33.0 ± 9.4 years; P = .021).

The trends of later onset with more pregnancies was also observed with the mean age of onset of secondary progressive MS (no full pregnancies: onset at 41.5 ± 9.2 years; 1-3 pregnancies: 46.2 ± 9.9 years; 4 or more pregnancies, onset 52.6 ± 12.9 years; P = .010).

And likewise, the later mean age of onset of relapsing-remitting MS was seen with additional pregnancies (no full pregnancies: 27.5 ± 7.0 years; 1-3 pregnancies: 32.4 ± 9.3 years; 4 or more pregnancies: 35.8 ± 9.8 years; P = .012).

“The dose effect was clearly a surprise (having no full-term pregnancies vs. 1-3 vs. 4 or more),” Dr. Zeydan said.

“In addition to the significant difference between having no versus one or more full-term pregnancies, the clear dose-effect consolidates our results related to the association between the number of pregnancies and age at progressive MS onset.”

Early menopause also linked to shorter progression to secondary progressive MS

The study also showed that women with premature or early menopause had a shorter duration of progressing from relapsing-remitting MS to secondary progressive MS (n = 26; 12.9 ± 9.0 years) compared to women with normal age at menopause (n = 39; 17.8 ± 10.3 years).

The pattern was similar for women experiencing the onset of secondary progressive MS after menopause, with a shorter progression among those with early menopause (P = .012).

The patterns in early menopause are consistent with previous observations regarding menopause and MS progression, Dr. Cohen said.

“When women go through menopause, estradiol and pregnancy-related factors further decline and we know this coincides temporally with the development of progressive MS in women,” he noted.

Compared to men, women with premature or early menopause furthermore had a longer duration from relapsing-remitting MS to secondary progressive MS (P = .008), and women with secondary progressive MS also had also had an earlier age of relapsing-remitting MS onset than men (P = .018).

Possible mechanisms and applications of the findings

The mechanisms of pregnancy that could include a complex interaction between estrogen and factors such as astrocyte and microglia function, Dr. Zeydan explained.

“Estrogen, through various mechanisms of eliminating toxicity of highly activated neurons – including preventing proinflammatory molecule release, supporting mitochondria function thereby eliminating energy failure, and promoting remyelination – helps neuronal plasticity and delays neurodegeneration, which is closely related to the progressive phase of MS,” she said.

“One could easily make the probable association, while yet to be proven, that our findings may relate to these mechanisms,” Dr. Zeydan said.

The logical question of whether hormone replacement or some type of therapy that could mimic the effects of pregnancy could also benefit in delaying MS onset remained to be seen, Dr. Zeydan said.

“While we believe that is possible, particularly for delaying the onset of progressive phase, definitive evidence is lacking at this time,” Dr. Zeydan said.

“However, our study ultimately may lead to such a trial.”

In the meantime, the findings provide additional insights that may be beneficial in sharing with patients regarding pregnancy,” she said.

“As the contemporary problem in MS care is to delay or prevent progressive MS onset, our findings may suggest that how we counsel women with MS who are planning to get pregnant, or contemplating surgically induced menopause, or how we consider hormone therapies during perimenopause may impact the course of their disease.”

Dr. Zeydan cautioned, however, that “our findings do not confirm causality beyond an association.”

“More studies are needed in this important issue in a disease that affects women three times more than men.”

Dr. Zeydan had no disclosures to report. Dr. Cohen reported receiving personal compensation for consulting for Adamas, Convelo, MedDay, Mylan, and Population Council; and serving as an Editor of Multiple Sclerosis Journal.

SOURCE: Zeydan B et al. ACTRIMS Forum 2020, Abstract P135.