The January 2021 issue of JAMA Neurology had an article that stated that the current U.S. spending on emergency room (ER) and inpatient costs for patients with functional neurological disorders is $1.2 billion and climbing. That doesn’t include, obviously, the costs of treating functional disorders in other specialties.

Dr. Block has a solo neurology practice in Scottsdale, Ariz.

The January 2021 issue of JAMA Neurology had an article that stated that the current U.S. spending on emergency room (ER) and inpatient costs for patients with functional neurological disorders is $1.2 billion and climbing. That doesn’t include, obviously, the costs of treating functional disorders in other specialties.

Dr. Block has a solo neurology practice in Scottsdale, Ariz.

The January 2021 issue of JAMA Neurology had an article that stated that the current U.S. spending on emergency room (ER) and inpatient costs for patients with functional neurological disorders is $1.2 billion and climbing. That doesn’t include, obviously, the costs of treating functional disorders in other specialties.

Dr. Block has a solo neurology practice in Scottsdale, Ariz.

Background: A new update to the Choosing Wisely Campaign was released September 2019.

• Not routinely using broad respiratory viral testing and instead using more targeted approaches to respiratory pathogen tests (e.g., respiratory syncytial virus, influenza A/B, or group A pharyngitis) unless the results will lead to changes to or discontinuations of antimicrobial therapy or isolation.
• Not routinely testing for community gastrointestinal pathogens in patients that develop diarrhea 3 days after hospitalization and to primarily test for Clostridiodes difficile in these patients, unless they are immunocompromised or older adults.
• Not checking procalcitonin unless a specific evidence-based guideline is used for antibiotic stewardship, as it is often used incorrectly without benefit to the patient.
• Not ordering serology for Helicobacter pylori and instead ordering the stool antigen or breath test to test for active infection given higher sensitivity and specificity.
• Not repeating antibody tests for patients with history of hepatitis C and instead ordering a viral load if there is concern for reinfection.

Bottom line: Only order infectious disease tests that will guide changes in clinical management.

Citation: ASCP Effective Test Utilization Steering Committee. Thirty things patients and physicians should question. 2019 Sep 9. Choosingwisely.org.

Dr. Blount is clinical instructor of medicine, hospital medicine, at the Rocky Mountain Veterans Affairs Regional Medical Center, Aurora, Colo.

Background: A new update to the Choosing Wisely Campaign was released September 2019.

• Not routinely using broad respiratory viral testing and instead using more targeted approaches to respiratory pathogen tests (e.g., respiratory syncytial virus, influenza A/B, or group A pharyngitis) unless the results will lead to changes to or discontinuations of antimicrobial therapy or isolation.
• Not routinely testing for community gastrointestinal pathogens in patients that develop diarrhea 3 days after hospitalization and to primarily test for Clostridiodes difficile in these patients, unless they are immunocompromised or older adults.
• Not checking procalcitonin unless a specific evidence-based guideline is used for antibiotic stewardship, as it is often used incorrectly without benefit to the patient.
• Not ordering serology for Helicobacter pylori and instead ordering the stool antigen or breath test to test for active infection given higher sensitivity and specificity.
• Not repeating antibody tests for patients with history of hepatitis C and instead ordering a viral load if there is concern for reinfection.

Bottom line: Only order infectious disease tests that will guide changes in clinical management.

Citation: ASCP Effective Test Utilization Steering Committee. Thirty things patients and physicians should question. 2019 Sep 9. Choosingwisely.org.

Dr. Blount is clinical instructor of medicine, hospital medicine, at the Rocky Mountain Veterans Affairs Regional Medical Center, Aurora, Colo.

Background: A new update to the Choosing Wisely Campaign was released September 2019.

• Not routinely using broad respiratory viral testing and instead using more targeted approaches to respiratory pathogen tests (e.g., respiratory syncytial virus, influenza A/B, or group A pharyngitis) unless the results will lead to changes to or discontinuations of antimicrobial therapy or isolation.
• Not routinely testing for community gastrointestinal pathogens in patients that develop diarrhea 3 days after hospitalization and to primarily test for Clostridiodes difficile in these patients, unless they are immunocompromised or older adults.
• Not checking procalcitonin unless a specific evidence-based guideline is used for antibiotic stewardship, as it is often used incorrectly without benefit to the patient.
• Not ordering serology for Helicobacter pylori and instead ordering the stool antigen or breath test to test for active infection given higher sensitivity and specificity.
• Not repeating antibody tests for patients with history of hepatitis C and instead ordering a viral load if there is concern for reinfection.

Bottom line: Only order infectious disease tests that will guide changes in clinical management.

Citation: ASCP Effective Test Utilization Steering Committee. Thirty things patients and physicians should question. 2019 Sep 9. Choosingwisely.org.

Dr. Blount is clinical instructor of medicine, hospital medicine, at the Rocky Mountain Veterans Affairs Regional Medical Center, Aurora, Colo.

Antibodies against SARS-CoV-2 cross the placenta during pregnancy and are detectable in most newborns born to mothers who had COVID-19 during pregnancy, according to findings from a study presented Jan. 28 at the meeting sponsored by the Society for Maternal-Fetal Medicine.

“I think the most striking finding is that we noticed a high degree of neutralizing response to natural infection even among asymptomatic infection, but of course a higher degree was seen in those with symptomatic infection,” Naima Joseph, MD, MPH, of Emory University, Atlanta, said in an interview.

“Our data demonstrate maternal capacity to mount an appropriate and robust immune response,” and maternal protective immunity lasted at least 28 days after infection, Dr. Joseph said. “Also, we noted higher neonatal cord blood titers in moms with higher titers, which suggests a relationship, but we need to better understand how transplacental transfer occurs as well as establish neonatal correlates of protection in order to see if and how maternal immunity may also benefit neonates.”

The researchers analyzed the amount of IgG and IgM antibodies in maternal and cord blood samples prospectively collected at delivery from women who tested positive for COVID-19 at any time while pregnant. They used enzyme-linked immunosorbent assay to assess for antibodies for the receptor binding domain of the SARS-CoV-2 spike protein.

The 32 pairs of mothers and infants in the study were predominantly non-Hispanic Black (72%) and Hispanic (25%), and 84% used Medicaid as their payer. Most of the mothers (72%) had at least one comorbidity, most commonly obesity, hypertension, and asthma or pulmonary disease. Just over half the women (53%) were symptomatic while they were infected, and 88% were ill with COVID-19 during the third trimester. The average time from infection to delivery was 28 days.

All the mothers had IgG antibodies, 94% had IgM antibodies, and 94% had neutralizing antibodies against SARS-CoV-2. Among the cord blood samples, 91% had IgG antibodies, 9% had IgM antibodies, and 25% had neutralizing antibodies.

“It’s reassuring that, so far, the physiological response is exactly what we expected it to be,” Judette Louis, MD, MPH, an associate professor of ob.gyn. and the ob.gyn. department chair at the University of South Florida, Tampa, said in an interview. “It’s what we would expect, but it’s always helpful to have more data to support that. Otherwise, you’re extrapolating from what you know from other conditions,” said Dr. Louis, who moderated the oral abstracts session.

Symptomatic infection was associated with significantly higher IgG titers than asymptomatic infection (P = .03), but no correlation was seen for IgM or neutralizing antibodies. In addition, although mothers who delivered more than 28 days after their infection had higher IgG titers (P = .05), no differences existed in IgM or neutralizing response.

Infants’ cord blood titers were significantly lower than their corresponding maternal samples, independently of symptoms or latency from infection to delivery (P < .001), Dr. Joseph reported.

“Transplacental efficiency in other pathogens has been shown to be correlated with neonatal immunity when the ratio of cord to maternal blood is greater than 1,” Dr. Joseph said in her presentation. Their data showed “suboptimal efficiency” at a ratio of 0.81.

The study’s small sample size and lack of a control group were weaknesses, but a major strength was having a population at disproportionately higher risk for infection and severe morbidity than the general population.
 

Implications for maternal COVID-19 vaccination

Although the data are not yet available, Dr. Joseph said they have expanded their protocol to include vaccinated pregnant women.

“The key to developing an effective vaccine [for pregnant people] is in really characterizing adaptive immunity in pregnancy,” Dr. Joseph told SMFM attendees. “I think that these findings inform further vaccine development in demonstrating that maternal immunity is robust.”

The World Health Organization recently recommended withholding COVID-19 vaccines from pregnant people, but the SMFM and American College of Obstetricians and Gynecologists subsequently issued a joint statement reaffirming that the COVID-19 vaccines authorized by the FDA “should not be withheld from pregnant individuals who choose to receive the vaccine.”

“One of the questions people ask is whether in pregnancy you’re going to mount a good response to the vaccine the way you would outside of pregnancy,” Dr. Louis said. “If we can demonstrate that you do, that may provide the information that some mothers need to make their decisions.” Data such as those from Dr. Joseph’s study can also inform recommendations on timing of maternal vaccination.

“For instance, Dr. Joseph demonstrated that, 28 days out from the infection, you had more antibodies, so there may be a scenario where we say this vaccine may be more beneficial in the middle of the pregnancy for the purpose of forming those antibodies,” Dr. Louis said.
 

Consensus emerging from maternal antibodies data

The findings from Dr. Joseph’s study mirror those reported in a study published online Jan. 29 in JAMA Pediatrics. That study, led by Dustin D. Flannery, DO, MSCE, of Children’s Hospital of Philadelphia, also examined maternal and neonatal levels of IgG and IgM antibodies against the receptor binding domain of the SARS-CoV-2 spike protein. They also found a positive correlation between cord blood and maternal IgG concentrations (P < .001), but notably, the ratio of cord to maternal blood titers was greater than 1, unlike in Dr. Joseph’s study.

For their study, Dr. Flannery and colleagues obtained maternal and cord blood sera at the time of delivery from 1471 pairs of mothers and infants, independently of COVID status during pregnancy. The average maternal age was 32 years, and just over a quarter of the population (26%) were Black, non-Hispanic women. About half (51%) were White, 12% were Hispanic, and 7% were Asian.

About 6% of the women had either IgG or IgM antibodies at delivery, and 87% of infants born to those mothers had measurable IgG in their cord blood. No infants had IgM antibodies. As with the study presented at SMFM, the mothers’ infections included asymptomatic, mild, moderate, and severe cases, and the degree of severity of cases had no apparent effect on infant antibody concentrations. Most of the women who tested positive for COVID-19 (60%) were asymptomatic.

Among the 11 mothers who had antibodies but whose infants’ cord blood did not, 5 had only IgM antibodies, and 6 had significantly lower IgG concentrations than those seen in the other mothers.

In a commentary about the JAMA Pediatrics study, Flor Munoz, MD, of the Baylor College of Medicine, Houston, suggested that the findings are grounds for optimism about a maternal vaccination strategy to protect infants from COVID-19.

“However, the timing of maternal vaccination to protect the infant, as opposed to the mother alone, would necessitate an adequate interval from vaccination to delivery (of at least 4 weeks), while vaccination early in gestation and even late in the third trimester could still be protective for the mother,” Dr. Munoz wrote.

Given the interval between two-dose vaccination regimens and the fact that transplacental transfer begins at about the 17th week of gestation, “maternal vaccination starting in the early second trimester of gestation might be optimal to achieve the highest levels of antibodies in the newborn,” Dr. Munoz wrote. But questions remain, such as how effective the neonatal antibodies would be in protecting against COVID-19 and how long they last after birth.

No external funding was used in Dr. Joseph’s study. Dr. Joseph and Dr. Louis have disclosed no relevant financial relationships. The JAMA Pediatrics study was funded by the Children’s Hospital of Philadelphia. One coauthor received consultancy fees from Sanofi Pasteur, Lumen, Novavax, and Merck unrelated to the study. Dr. Munoz served on the data and safety monitoring boards of Moderna, Pfizer, Virometix, and Meissa Vaccines and has received grants from Novavax Research and Gilead Research.

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

Antibodies against SARS-CoV-2 cross the placenta during pregnancy and are detectable in most newborns born to mothers who had COVID-19 during pregnancy, according to findings from a study presented Jan. 28 at the meeting sponsored by the Society for Maternal-Fetal Medicine.

“I think the most striking finding is that we noticed a high degree of neutralizing response to natural infection even among asymptomatic infection, but of course a higher degree was seen in those with symptomatic infection,” Naima Joseph, MD, MPH, of Emory University, Atlanta, said in an interview.

“Our data demonstrate maternal capacity to mount an appropriate and robust immune response,” and maternal protective immunity lasted at least 28 days after infection, Dr. Joseph said. “Also, we noted higher neonatal cord blood titers in moms with higher titers, which suggests a relationship, but we need to better understand how transplacental transfer occurs as well as establish neonatal correlates of protection in order to see if and how maternal immunity may also benefit neonates.”

The researchers analyzed the amount of IgG and IgM antibodies in maternal and cord blood samples prospectively collected at delivery from women who tested positive for COVID-19 at any time while pregnant. They used enzyme-linked immunosorbent assay to assess for antibodies for the receptor binding domain of the SARS-CoV-2 spike protein.

The 32 pairs of mothers and infants in the study were predominantly non-Hispanic Black (72%) and Hispanic (25%), and 84% used Medicaid as their payer. Most of the mothers (72%) had at least one comorbidity, most commonly obesity, hypertension, and asthma or pulmonary disease. Just over half the women (53%) were symptomatic while they were infected, and 88% were ill with COVID-19 during the third trimester. The average time from infection to delivery was 28 days.

All the mothers had IgG antibodies, 94% had IgM antibodies, and 94% had neutralizing antibodies against SARS-CoV-2. Among the cord blood samples, 91% had IgG antibodies, 9% had IgM antibodies, and 25% had neutralizing antibodies.

“It’s reassuring that, so far, the physiological response is exactly what we expected it to be,” Judette Louis, MD, MPH, an associate professor of ob.gyn. and the ob.gyn. department chair at the University of South Florida, Tampa, said in an interview. “It’s what we would expect, but it’s always helpful to have more data to support that. Otherwise, you’re extrapolating from what you know from other conditions,” said Dr. Louis, who moderated the oral abstracts session.

Symptomatic infection was associated with significantly higher IgG titers than asymptomatic infection (P = .03), but no correlation was seen for IgM or neutralizing antibodies. In addition, although mothers who delivered more than 28 days after their infection had higher IgG titers (P = .05), no differences existed in IgM or neutralizing response.

Infants’ cord blood titers were significantly lower than their corresponding maternal samples, independently of symptoms or latency from infection to delivery (P < .001), Dr. Joseph reported.

“Transplacental efficiency in other pathogens has been shown to be correlated with neonatal immunity when the ratio of cord to maternal blood is greater than 1,” Dr. Joseph said in her presentation. Their data showed “suboptimal efficiency” at a ratio of 0.81.

The study’s small sample size and lack of a control group were weaknesses, but a major strength was having a population at disproportionately higher risk for infection and severe morbidity than the general population.
 

Implications for maternal COVID-19 vaccination

Although the data are not yet available, Dr. Joseph said they have expanded their protocol to include vaccinated pregnant women.

“The key to developing an effective vaccine [for pregnant people] is in really characterizing adaptive immunity in pregnancy,” Dr. Joseph told SMFM attendees. “I think that these findings inform further vaccine development in demonstrating that maternal immunity is robust.”

The World Health Organization recently recommended withholding COVID-19 vaccines from pregnant people, but the SMFM and American College of Obstetricians and Gynecologists subsequently issued a joint statement reaffirming that the COVID-19 vaccines authorized by the FDA “should not be withheld from pregnant individuals who choose to receive the vaccine.”

“One of the questions people ask is whether in pregnancy you’re going to mount a good response to the vaccine the way you would outside of pregnancy,” Dr. Louis said. “If we can demonstrate that you do, that may provide the information that some mothers need to make their decisions.” Data such as those from Dr. Joseph’s study can also inform recommendations on timing of maternal vaccination.

“For instance, Dr. Joseph demonstrated that, 28 days out from the infection, you had more antibodies, so there may be a scenario where we say this vaccine may be more beneficial in the middle of the pregnancy for the purpose of forming those antibodies,” Dr. Louis said.
 

Consensus emerging from maternal antibodies data

The findings from Dr. Joseph’s study mirror those reported in a study published online Jan. 29 in JAMA Pediatrics. That study, led by Dustin D. Flannery, DO, MSCE, of Children’s Hospital of Philadelphia, also examined maternal and neonatal levels of IgG and IgM antibodies against the receptor binding domain of the SARS-CoV-2 spike protein. They also found a positive correlation between cord blood and maternal IgG concentrations (P < .001), but notably, the ratio of cord to maternal blood titers was greater than 1, unlike in Dr. Joseph’s study.

For their study, Dr. Flannery and colleagues obtained maternal and cord blood sera at the time of delivery from 1471 pairs of mothers and infants, independently of COVID status during pregnancy. The average maternal age was 32 years, and just over a quarter of the population (26%) were Black, non-Hispanic women. About half (51%) were White, 12% were Hispanic, and 7% were Asian.

About 6% of the women had either IgG or IgM antibodies at delivery, and 87% of infants born to those mothers had measurable IgG in their cord blood. No infants had IgM antibodies. As with the study presented at SMFM, the mothers’ infections included asymptomatic, mild, moderate, and severe cases, and the degree of severity of cases had no apparent effect on infant antibody concentrations. Most of the women who tested positive for COVID-19 (60%) were asymptomatic.

Among the 11 mothers who had antibodies but whose infants’ cord blood did not, 5 had only IgM antibodies, and 6 had significantly lower IgG concentrations than those seen in the other mothers.

In a commentary about the JAMA Pediatrics study, Flor Munoz, MD, of the Baylor College of Medicine, Houston, suggested that the findings are grounds for optimism about a maternal vaccination strategy to protect infants from COVID-19.

“However, the timing of maternal vaccination to protect the infant, as opposed to the mother alone, would necessitate an adequate interval from vaccination to delivery (of at least 4 weeks), while vaccination early in gestation and even late in the third trimester could still be protective for the mother,” Dr. Munoz wrote.

Given the interval between two-dose vaccination regimens and the fact that transplacental transfer begins at about the 17th week of gestation, “maternal vaccination starting in the early second trimester of gestation might be optimal to achieve the highest levels of antibodies in the newborn,” Dr. Munoz wrote. But questions remain, such as how effective the neonatal antibodies would be in protecting against COVID-19 and how long they last after birth.

No external funding was used in Dr. Joseph’s study. Dr. Joseph and Dr. Louis have disclosed no relevant financial relationships. The JAMA Pediatrics study was funded by the Children’s Hospital of Philadelphia. One coauthor received consultancy fees from Sanofi Pasteur, Lumen, Novavax, and Merck unrelated to the study. Dr. Munoz served on the data and safety monitoring boards of Moderna, Pfizer, Virometix, and Meissa Vaccines and has received grants from Novavax Research and Gilead Research.

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

Antibodies against SARS-CoV-2 cross the placenta during pregnancy and are detectable in most newborns born to mothers who had COVID-19 during pregnancy, according to findings from a study presented Jan. 28 at the meeting sponsored by the Society for Maternal-Fetal Medicine.

“I think the most striking finding is that we noticed a high degree of neutralizing response to natural infection even among asymptomatic infection, but of course a higher degree was seen in those with symptomatic infection,” Naima Joseph, MD, MPH, of Emory University, Atlanta, said in an interview.

“Our data demonstrate maternal capacity to mount an appropriate and robust immune response,” and maternal protective immunity lasted at least 28 days after infection, Dr. Joseph said. “Also, we noted higher neonatal cord blood titers in moms with higher titers, which suggests a relationship, but we need to better understand how transplacental transfer occurs as well as establish neonatal correlates of protection in order to see if and how maternal immunity may also benefit neonates.”

The researchers analyzed the amount of IgG and IgM antibodies in maternal and cord blood samples prospectively collected at delivery from women who tested positive for COVID-19 at any time while pregnant. They used enzyme-linked immunosorbent assay to assess for antibodies for the receptor binding domain of the SARS-CoV-2 spike protein.

The 32 pairs of mothers and infants in the study were predominantly non-Hispanic Black (72%) and Hispanic (25%), and 84% used Medicaid as their payer. Most of the mothers (72%) had at least one comorbidity, most commonly obesity, hypertension, and asthma or pulmonary disease. Just over half the women (53%) were symptomatic while they were infected, and 88% were ill with COVID-19 during the third trimester. The average time from infection to delivery was 28 days.

All the mothers had IgG antibodies, 94% had IgM antibodies, and 94% had neutralizing antibodies against SARS-CoV-2. Among the cord blood samples, 91% had IgG antibodies, 9% had IgM antibodies, and 25% had neutralizing antibodies.

“It’s reassuring that, so far, the physiological response is exactly what we expected it to be,” Judette Louis, MD, MPH, an associate professor of ob.gyn. and the ob.gyn. department chair at the University of South Florida, Tampa, said in an interview. “It’s what we would expect, but it’s always helpful to have more data to support that. Otherwise, you’re extrapolating from what you know from other conditions,” said Dr. Louis, who moderated the oral abstracts session.

Symptomatic infection was associated with significantly higher IgG titers than asymptomatic infection (P = .03), but no correlation was seen for IgM or neutralizing antibodies. In addition, although mothers who delivered more than 28 days after their infection had higher IgG titers (P = .05), no differences existed in IgM or neutralizing response.

Infants’ cord blood titers were significantly lower than their corresponding maternal samples, independently of symptoms or latency from infection to delivery (P < .001), Dr. Joseph reported.

“Transplacental efficiency in other pathogens has been shown to be correlated with neonatal immunity when the ratio of cord to maternal blood is greater than 1,” Dr. Joseph said in her presentation. Their data showed “suboptimal efficiency” at a ratio of 0.81.

The study’s small sample size and lack of a control group were weaknesses, but a major strength was having a population at disproportionately higher risk for infection and severe morbidity than the general population.
 

Implications for maternal COVID-19 vaccination

Although the data are not yet available, Dr. Joseph said they have expanded their protocol to include vaccinated pregnant women.

“The key to developing an effective vaccine [for pregnant people] is in really characterizing adaptive immunity in pregnancy,” Dr. Joseph told SMFM attendees. “I think that these findings inform further vaccine development in demonstrating that maternal immunity is robust.”

The World Health Organization recently recommended withholding COVID-19 vaccines from pregnant people, but the SMFM and American College of Obstetricians and Gynecologists subsequently issued a joint statement reaffirming that the COVID-19 vaccines authorized by the FDA “should not be withheld from pregnant individuals who choose to receive the vaccine.”

“One of the questions people ask is whether in pregnancy you’re going to mount a good response to the vaccine the way you would outside of pregnancy,” Dr. Louis said. “If we can demonstrate that you do, that may provide the information that some mothers need to make their decisions.” Data such as those from Dr. Joseph’s study can also inform recommendations on timing of maternal vaccination.

“For instance, Dr. Joseph demonstrated that, 28 days out from the infection, you had more antibodies, so there may be a scenario where we say this vaccine may be more beneficial in the middle of the pregnancy for the purpose of forming those antibodies,” Dr. Louis said.
 

Consensus emerging from maternal antibodies data

The findings from Dr. Joseph’s study mirror those reported in a study published online Jan. 29 in JAMA Pediatrics. That study, led by Dustin D. Flannery, DO, MSCE, of Children’s Hospital of Philadelphia, also examined maternal and neonatal levels of IgG and IgM antibodies against the receptor binding domain of the SARS-CoV-2 spike protein. They also found a positive correlation between cord blood and maternal IgG concentrations (P < .001), but notably, the ratio of cord to maternal blood titers was greater than 1, unlike in Dr. Joseph’s study.

For their study, Dr. Flannery and colleagues obtained maternal and cord blood sera at the time of delivery from 1471 pairs of mothers and infants, independently of COVID status during pregnancy. The average maternal age was 32 years, and just over a quarter of the population (26%) were Black, non-Hispanic women. About half (51%) were White, 12% were Hispanic, and 7% were Asian.

About 6% of the women had either IgG or IgM antibodies at delivery, and 87% of infants born to those mothers had measurable IgG in their cord blood. No infants had IgM antibodies. As with the study presented at SMFM, the mothers’ infections included asymptomatic, mild, moderate, and severe cases, and the degree of severity of cases had no apparent effect on infant antibody concentrations. Most of the women who tested positive for COVID-19 (60%) were asymptomatic.

Among the 11 mothers who had antibodies but whose infants’ cord blood did not, 5 had only IgM antibodies, and 6 had significantly lower IgG concentrations than those seen in the other mothers.

In a commentary about the JAMA Pediatrics study, Flor Munoz, MD, of the Baylor College of Medicine, Houston, suggested that the findings are grounds for optimism about a maternal vaccination strategy to protect infants from COVID-19.

“However, the timing of maternal vaccination to protect the infant, as opposed to the mother alone, would necessitate an adequate interval from vaccination to delivery (of at least 4 weeks), while vaccination early in gestation and even late in the third trimester could still be protective for the mother,” Dr. Munoz wrote.

Given the interval between two-dose vaccination regimens and the fact that transplacental transfer begins at about the 17th week of gestation, “maternal vaccination starting in the early second trimester of gestation might be optimal to achieve the highest levels of antibodies in the newborn,” Dr. Munoz wrote. But questions remain, such as how effective the neonatal antibodies would be in protecting against COVID-19 and how long they last after birth.

No external funding was used in Dr. Joseph’s study. Dr. Joseph and Dr. Louis have disclosed no relevant financial relationships. The JAMA Pediatrics study was funded by the Children’s Hospital of Philadelphia. One coauthor received consultancy fees from Sanofi Pasteur, Lumen, Novavax, and Merck unrelated to the study. Dr. Munoz served on the data and safety monitoring boards of Moderna, Pfizer, Virometix, and Meissa Vaccines and has received grants from Novavax Research and Gilead Research.

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

Li et al looked at risk of thromboembolic disease in patients with RA within the first 5 years of diagnosis compared to those without RA. Using a population database in British Columbia, Canada, 39,142 RA patients were matched to 78,078 non-RA patients and those with prior venous thromboembolism (VTE) were excluded. Incidence rates of VTE, pulmonary embolism (PE), and deep venous thrombosis (DVT) were higher among the RA cohort than the non-RA cohort; this observation held true after adjusting for age, sex, glucocorticoid, and contraceptive use. It would be interesting to know if the increased risk holds true after control of inflammation (i.e. in patients with established RA in low vs. high disease activity states). In the absence of information about BMI and tobacco use, more studies are necessary to provide further support for this finding.

As noted above, RA is associated with cardiovascular disease (CVD), along with risk of death from cardiovascular complications. Because CVD is itself a risk factor for dementia, Sattui et al examined the potential for systemic inflammation and CVD to increase risk of developing dementia in RA patients. Using CMS claims data from 2006 to 2014, they studied 56,000 RA patients age 65 or older and looked at risk of dementia according to CVD status (no CVD or risk factors, CVD risk factors without disease, and CVD). Incidence rates for dementia were higher among RA patients with CVD risk factors than those without, and highest among RA patients with CVD. This effect was age-dependent, with a more significant risk among RA patients age 65-74, perhaps because of a general increase in dementia in older adults. As RA disease activity was not obtainable in this study, the effects of systemic inflammation are difficult to attribute. In addition, there may be some misclassification of data regarding coding of dementia subtypes (i.e. vascular and Alzheimer dementia). However, as there are limited studies in this area, this study provides credible evidence for an increase in dementia in RA patients with CVD, which should be further investigated.

Finally, hydroxychloroquine (HCQ) has come under increased scrutiny in the past year in terms of its potential use outside of treatment of lupus and RA as well as potential side effects. Cardiac toxicity related to HCQ is thought to be rare; Sorour et al looked at the association between chronic HCQ use in patients with RA and the development of heart failure (HF) using a retrospective study comparing patients who developed HF after RA diagnosis to those who did not develop HF. HCQ use was similar in both groups and a higher cumulative HCQ dose was not associated with increased risk of HF. As it is small and retrospective, larger prospective studies would be helpful, but this remains reassuring as to the safety of HCQ in RA patients.

Li et al looked at risk of thromboembolic disease in patients with RA within the first 5 years of diagnosis compared to those without RA. Using a population database in British Columbia, Canada, 39,142 RA patients were matched to 78,078 non-RA patients and those with prior venous thromboembolism (VTE) were excluded. Incidence rates of VTE, pulmonary embolism (PE), and deep venous thrombosis (DVT) were higher among the RA cohort than the non-RA cohort; this observation held true after adjusting for age, sex, glucocorticoid, and contraceptive use. It would be interesting to know if the increased risk holds true after control of inflammation (i.e. in patients with established RA in low vs. high disease activity states). In the absence of information about BMI and tobacco use, more studies are necessary to provide further support for this finding.

As noted above, RA is associated with cardiovascular disease (CVD), along with risk of death from cardiovascular complications. Because CVD is itself a risk factor for dementia, Sattui et al examined the potential for systemic inflammation and CVD to increase risk of developing dementia in RA patients. Using CMS claims data from 2006 to 2014, they studied 56,000 RA patients age 65 or older and looked at risk of dementia according to CVD status (no CVD or risk factors, CVD risk factors without disease, and CVD). Incidence rates for dementia were higher among RA patients with CVD risk factors than those without, and highest among RA patients with CVD. This effect was age-dependent, with a more significant risk among RA patients age 65-74, perhaps because of a general increase in dementia in older adults. As RA disease activity was not obtainable in this study, the effects of systemic inflammation are difficult to attribute. In addition, there may be some misclassification of data regarding coding of dementia subtypes (i.e. vascular and Alzheimer dementia). However, as there are limited studies in this area, this study provides credible evidence for an increase in dementia in RA patients with CVD, which should be further investigated.

Finally, hydroxychloroquine (HCQ) has come under increased scrutiny in the past year in terms of its potential use outside of treatment of lupus and RA as well as potential side effects. Cardiac toxicity related to HCQ is thought to be rare; Sorour et al looked at the association between chronic HCQ use in patients with RA and the development of heart failure (HF) using a retrospective study comparing patients who developed HF after RA diagnosis to those who did not develop HF. HCQ use was similar in both groups and a higher cumulative HCQ dose was not associated with increased risk of HF. As it is small and retrospective, larger prospective studies would be helpful, but this remains reassuring as to the safety of HCQ in RA patients.

Li et al looked at risk of thromboembolic disease in patients with RA within the first 5 years of diagnosis compared to those without RA. Using a population database in British Columbia, Canada, 39,142 RA patients were matched to 78,078 non-RA patients and those with prior venous thromboembolism (VTE) were excluded. Incidence rates of VTE, pulmonary embolism (PE), and deep venous thrombosis (DVT) were higher among the RA cohort than the non-RA cohort; this observation held true after adjusting for age, sex, glucocorticoid, and contraceptive use. It would be interesting to know if the increased risk holds true after control of inflammation (i.e. in patients with established RA in low vs. high disease activity states). In the absence of information about BMI and tobacco use, more studies are necessary to provide further support for this finding.

As noted above, RA is associated with cardiovascular disease (CVD), along with risk of death from cardiovascular complications. Because CVD is itself a risk factor for dementia, Sattui et al examined the potential for systemic inflammation and CVD to increase risk of developing dementia in RA patients. Using CMS claims data from 2006 to 2014, they studied 56,000 RA patients age 65 or older and looked at risk of dementia according to CVD status (no CVD or risk factors, CVD risk factors without disease, and CVD). Incidence rates for dementia were higher among RA patients with CVD risk factors than those without, and highest among RA patients with CVD. This effect was age-dependent, with a more significant risk among RA patients age 65-74, perhaps because of a general increase in dementia in older adults. As RA disease activity was not obtainable in this study, the effects of systemic inflammation are difficult to attribute. In addition, there may be some misclassification of data regarding coding of dementia subtypes (i.e. vascular and Alzheimer dementia). However, as there are limited studies in this area, this study provides credible evidence for an increase in dementia in RA patients with CVD, which should be further investigated.

Finally, hydroxychloroquine (HCQ) has come under increased scrutiny in the past year in terms of its potential use outside of treatment of lupus and RA as well as potential side effects. Cardiac toxicity related to HCQ is thought to be rare; Sorour et al looked at the association between chronic HCQ use in patients with RA and the development of heart failure (HF) using a retrospective study comparing patients who developed HF after RA diagnosis to those who did not develop HF. HCQ use was similar in both groups and a higher cumulative HCQ dose was not associated with increased risk of HF. As it is small and retrospective, larger prospective studies would be helpful, but this remains reassuring as to the safety of HCQ in RA patients.

Daily treatment with tofacitinib (Xeljanz) led to more malignancies and adverse cardiovascular events in older rheumatoid arthritis patients compared with treatment with a tumor necrosis factor (TNF) inhibitor, according to the partial results of a safety study announced last week by Pfizer.

The postmarketing study known as ORAL Surveillance began in 2014 to evaluate the safety of the Janus kinase (JAK) inhibitor tofacitinib compared to a TNF inhibitor in RA patients 50 years of age or older with at least one additional cardiovascular risk factor. Its 4,362 participants were randomized to either daily doses of 5 mg (n = 1,455) or 10 mg (n = 1,456) of tofacitinib or the TNFi (n = 1,451), which was adalimumab for patients in the United States, Canada, and Puerto Rico, and etanercept elsewhere. During analysis, adverse events were pooled for all patients on tofacitinib.

Overall, 135 patients developed major adverse cardiovascular events (MACE) and 164 developed malignancies – excluding nonmelanoma skin cancer. The incidence of adjudicated malignancies was significantly higher in the tofacitinib group, compared with the TNFi group (1.13 vs. 0.77 per 100 person-years; hazard ratio, 1.48; 95% confidence interval, 1.04-2.09). The rate of MACE was also higher in the combined tofacitinib group (0.98 vs. 0.73 per 100 person-years; HR, 1.33; 95% CI, 0.91-1.94). Both rates for tofacitinib did not meet the trial’s noninferiority criteria.

Among the patients on tofacitinib, the most reported MACE was myocardial infarction and the most reported malignancy was lung cancer. Study participants with noted risk factors – including older age and smoking – were more likely to experience adverse events.

In February 2019, patients in the 10-mg tofacitinib group were switched to the 5-mg because of a safety signal indicating increased risk of pulmonary embolism and death.

Tofacitinib was approved for RA in November 2012, though concerns about serious side effects had been noted during clinical trials and a boxed warning was ultimately added to the drug’s label. Tofacitinib is also approved for adults with active psoriatic arthritis, adults with moderately to severely active ulcerative colitis, and patients aged 2 years or older with active polyarticular course juvenile idiopathic arthritis. Other JAK inhibitors such as baricitinib and upadacitinib have been approved for RA in the interim as well, though the higher dose of baricitinib was rejected in committee because of safety concerns and both their boxes also warn against infections, thrombosis, and cancer.

A postmarketing safety study on baricitinib is expected to be completed in 2025.

The full results of the ORAL Surveillance study – which should address safety regarding pulmonary embolism and mortality, as well as efficacy data – have not yet been released. “Pfizer is working with the [FDA] and other regulatory agencies to review the full results and analyses as they become available,” the press release said.

Daily treatment with tofacitinib (Xeljanz) led to more malignancies and adverse cardiovascular events in older rheumatoid arthritis patients compared with treatment with a tumor necrosis factor (TNF) inhibitor, according to the partial results of a safety study announced last week by Pfizer.

The postmarketing study known as ORAL Surveillance began in 2014 to evaluate the safety of the Janus kinase (JAK) inhibitor tofacitinib compared to a TNF inhibitor in RA patients 50 years of age or older with at least one additional cardiovascular risk factor. Its 4,362 participants were randomized to either daily doses of 5 mg (n = 1,455) or 10 mg (n = 1,456) of tofacitinib or the TNFi (n = 1,451), which was adalimumab for patients in the United States, Canada, and Puerto Rico, and etanercept elsewhere. During analysis, adverse events were pooled for all patients on tofacitinib.

Overall, 135 patients developed major adverse cardiovascular events (MACE) and 164 developed malignancies – excluding nonmelanoma skin cancer. The incidence of adjudicated malignancies was significantly higher in the tofacitinib group, compared with the TNFi group (1.13 vs. 0.77 per 100 person-years; hazard ratio, 1.48; 95% confidence interval, 1.04-2.09). The rate of MACE was also higher in the combined tofacitinib group (0.98 vs. 0.73 per 100 person-years; HR, 1.33; 95% CI, 0.91-1.94). Both rates for tofacitinib did not meet the trial’s noninferiority criteria.

Among the patients on tofacitinib, the most reported MACE was myocardial infarction and the most reported malignancy was lung cancer. Study participants with noted risk factors – including older age and smoking – were more likely to experience adverse events.

In February 2019, patients in the 10-mg tofacitinib group were switched to the 5-mg because of a safety signal indicating increased risk of pulmonary embolism and death.

Tofacitinib was approved for RA in November 2012, though concerns about serious side effects had been noted during clinical trials and a boxed warning was ultimately added to the drug’s label. Tofacitinib is also approved for adults with active psoriatic arthritis, adults with moderately to severely active ulcerative colitis, and patients aged 2 years or older with active polyarticular course juvenile idiopathic arthritis. Other JAK inhibitors such as baricitinib and upadacitinib have been approved for RA in the interim as well, though the higher dose of baricitinib was rejected in committee because of safety concerns and both their boxes also warn against infections, thrombosis, and cancer.

A postmarketing safety study on baricitinib is expected to be completed in 2025.

The full results of the ORAL Surveillance study – which should address safety regarding pulmonary embolism and mortality, as well as efficacy data – have not yet been released. “Pfizer is working with the [FDA] and other regulatory agencies to review the full results and analyses as they become available,” the press release said.

Daily treatment with tofacitinib (Xeljanz) led to more malignancies and adverse cardiovascular events in older rheumatoid arthritis patients compared with treatment with a tumor necrosis factor (TNF) inhibitor, according to the partial results of a safety study announced last week by Pfizer.

The postmarketing study known as ORAL Surveillance began in 2014 to evaluate the safety of the Janus kinase (JAK) inhibitor tofacitinib compared to a TNF inhibitor in RA patients 50 years of age or older with at least one additional cardiovascular risk factor. Its 4,362 participants were randomized to either daily doses of 5 mg (n = 1,455) or 10 mg (n = 1,456) of tofacitinib or the TNFi (n = 1,451), which was adalimumab for patients in the United States, Canada, and Puerto Rico, and etanercept elsewhere. During analysis, adverse events were pooled for all patients on tofacitinib.

Overall, 135 patients developed major adverse cardiovascular events (MACE) and 164 developed malignancies – excluding nonmelanoma skin cancer. The incidence of adjudicated malignancies was significantly higher in the tofacitinib group, compared with the TNFi group (1.13 vs. 0.77 per 100 person-years; hazard ratio, 1.48; 95% confidence interval, 1.04-2.09). The rate of MACE was also higher in the combined tofacitinib group (0.98 vs. 0.73 per 100 person-years; HR, 1.33; 95% CI, 0.91-1.94). Both rates for tofacitinib did not meet the trial’s noninferiority criteria.

Among the patients on tofacitinib, the most reported MACE was myocardial infarction and the most reported malignancy was lung cancer. Study participants with noted risk factors – including older age and smoking – were more likely to experience adverse events.

In February 2019, patients in the 10-mg tofacitinib group were switched to the 5-mg because of a safety signal indicating increased risk of pulmonary embolism and death.

Tofacitinib was approved for RA in November 2012, though concerns about serious side effects had been noted during clinical trials and a boxed warning was ultimately added to the drug’s label. Tofacitinib is also approved for adults with active psoriatic arthritis, adults with moderately to severely active ulcerative colitis, and patients aged 2 years or older with active polyarticular course juvenile idiopathic arthritis. Other JAK inhibitors such as baricitinib and upadacitinib have been approved for RA in the interim as well, though the higher dose of baricitinib was rejected in committee because of safety concerns and both their boxes also warn against infections, thrombosis, and cancer.

A postmarketing safety study on baricitinib is expected to be completed in 2025.

The full results of the ORAL Surveillance study – which should address safety regarding pulmonary embolism and mortality, as well as efficacy data – have not yet been released. “Pfizer is working with the [FDA] and other regulatory agencies to review the full results and analyses as they become available,” the press release said.

New data on COVID-19 vaccines should serve as a “wake-up call” about the need to stop the spread of the SARS-CoV-2 virus among people and thus deprive it of opportunities to evolve its defenses, the top federal expert on infectious diseases said.

“The virus will continue to mutate and will mutate for its own selective advantage,” said Anthony S. Fauci, MD, director of the National Institute of Allergy and Infectious Diseases, at a Friday news conference organized by the White House.

The continued transmission of SARS-CoV-2 “gives the virus the chance to adapt to the forces, in this case the immune response, that’s trying to get rid of it,” Dr. Fauci said. “That’s where you get mutations.”

Federal health officials are working to boost the U.S. supply of COVID-19 vaccines, even as signals emerge about the extent that the virus is already evolving.

Data released this week about the Janssen/Johnson & Johnson (J&J) and Novavax COVID-19 vaccines in late-stage development provides further evidence that they may not protect as well against emerging variants, Dr. Fauci said.

“Mutations that lead to different lineage do have clinical consequences,” he said, while also emphasizing that the emerging vaccines appear to confer broad protection. Dr. Fauci earlier in the day addressed the “messaging challenge” for clinicians and researchers in discussing the results of the J&J vaccine trial, which appear to fall short of those reported for the two vaccines already approved and in use in the United States. He noted the benefits of possibly soon having more authorized vaccines to combat COVID-19. But continued community spread of the infection will foster conditions that can undermine the vaccines’ effectiveness.

“Even though the long-range effect in the sense of severe disease is still handled reasonably well by the vaccines, this is a wake-up call to all of us,” Dr. Fauci said.

Pharmaceutical scientists and executives and government health officials will need to work together to continue to develop vaccines that can outwit the emerging variants, he said.

On Jan. 29, J&J reported that its highly anticipated single-dose vaccine had shown its worst results in South Africa where many cases of COVID-19 were caused by infection with a SARS-CoV-2 variant from the B.1.351 lineage. The overall efficacy was 66% globally, 72% in the United States, and 57% in South Africa against moderate to severe SARS-CoV-2, J&J said.

Novavax on Jan. 28 reported an efficacy rate for its COVID-19 vaccine of 49.4% from a clinical trial conducted in South Africa, compared with an 89.3% rate from a U.K. study. There already have been attempts to estimate how well the Pfizer/BioNTech and Moderna vaccines can handle new variants of the virus. They both have been granted emergency-use authorization by the U.S. Food and Drug Administration.
 

‘Genomic surveillance’

The Centers for Disease Control and Prevention on Thursday reported the first U.S.-documented cases of the B.1.351 variant of SARS-CoV-2 in South Carolina. On Jan. 26, the first confirmed U.S. case of a highly transmissible Brazilian coronavirus variant was detected in Minnesota, state health officials said.

The CDC’s stepped-up “genomic surveillance” will help keep clinicians and researchers aware of how SARS-CoV-2 is changing, Dr. Fauci said.

Speaking at the same White House news conference, CDC director Rochelle Walensky, MD, MPH, said the two South Carolina cases of the B.1.351 variant were reported in different parts of the state and not believed to be epidemiologically linked. The people involved “did not have any travel history,” she added.

The SARS-CoV-2 mutations were expected to emerge at some point, as with any virus, but their appearance underscores the need for people to remain vigilant about precautions that can stop its spread, Dr. Walensky said.

She and Dr. Fauci both stressed the need for continued use of masks and social distancing and urged people to get COVID-19 vaccines as they become available. Continued community spread of the virus allows this global health threat to keep replicating, and thus increases its chances to thwart medical interventions, Dr. Fauci said.

“The virus has a playing field, as it were, to mutate,” Dr. Fauci said. “If you stop that and stop the replication, the viruses cannot mutate if they don’t replicate.”

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

New data on COVID-19 vaccines should serve as a “wake-up call” about the need to stop the spread of the SARS-CoV-2 virus among people and thus deprive it of opportunities to evolve its defenses, the top federal expert on infectious diseases said.

“The virus will continue to mutate and will mutate for its own selective advantage,” said Anthony S. Fauci, MD, director of the National Institute of Allergy and Infectious Diseases, at a Friday news conference organized by the White House.

The continued transmission of SARS-CoV-2 “gives the virus the chance to adapt to the forces, in this case the immune response, that’s trying to get rid of it,” Dr. Fauci said. “That’s where you get mutations.”

Federal health officials are working to boost the U.S. supply of COVID-19 vaccines, even as signals emerge about the extent that the virus is already evolving.

Data released this week about the Janssen/Johnson & Johnson (J&J) and Novavax COVID-19 vaccines in late-stage development provides further evidence that they may not protect as well against emerging variants, Dr. Fauci said.

“Mutations that lead to different lineage do have clinical consequences,” he said, while also emphasizing that the emerging vaccines appear to confer broad protection. Dr. Fauci earlier in the day addressed the “messaging challenge” for clinicians and researchers in discussing the results of the J&J vaccine trial, which appear to fall short of those reported for the two vaccines already approved and in use in the United States. He noted the benefits of possibly soon having more authorized vaccines to combat COVID-19. But continued community spread of the infection will foster conditions that can undermine the vaccines’ effectiveness.

“Even though the long-range effect in the sense of severe disease is still handled reasonably well by the vaccines, this is a wake-up call to all of us,” Dr. Fauci said.

Pharmaceutical scientists and executives and government health officials will need to work together to continue to develop vaccines that can outwit the emerging variants, he said.

On Jan. 29, J&J reported that its highly anticipated single-dose vaccine had shown its worst results in South Africa where many cases of COVID-19 were caused by infection with a SARS-CoV-2 variant from the B.1.351 lineage. The overall efficacy was 66% globally, 72% in the United States, and 57% in South Africa against moderate to severe SARS-CoV-2, J&J said.

Novavax on Jan. 28 reported an efficacy rate for its COVID-19 vaccine of 49.4% from a clinical trial conducted in South Africa, compared with an 89.3% rate from a U.K. study. There already have been attempts to estimate how well the Pfizer/BioNTech and Moderna vaccines can handle new variants of the virus. They both have been granted emergency-use authorization by the U.S. Food and Drug Administration.
 

‘Genomic surveillance’

The Centers for Disease Control and Prevention on Thursday reported the first U.S.-documented cases of the B.1.351 variant of SARS-CoV-2 in South Carolina. On Jan. 26, the first confirmed U.S. case of a highly transmissible Brazilian coronavirus variant was detected in Minnesota, state health officials said.

The CDC’s stepped-up “genomic surveillance” will help keep clinicians and researchers aware of how SARS-CoV-2 is changing, Dr. Fauci said.

Speaking at the same White House news conference, CDC director Rochelle Walensky, MD, MPH, said the two South Carolina cases of the B.1.351 variant were reported in different parts of the state and not believed to be epidemiologically linked. The people involved “did not have any travel history,” she added.

The SARS-CoV-2 mutations were expected to emerge at some point, as with any virus, but their appearance underscores the need for people to remain vigilant about precautions that can stop its spread, Dr. Walensky said.

She and Dr. Fauci both stressed the need for continued use of masks and social distancing and urged people to get COVID-19 vaccines as they become available. Continued community spread of the virus allows this global health threat to keep replicating, and thus increases its chances to thwart medical interventions, Dr. Fauci said.

“The virus has a playing field, as it were, to mutate,” Dr. Fauci said. “If you stop that and stop the replication, the viruses cannot mutate if they don’t replicate.”

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

New data on COVID-19 vaccines should serve as a “wake-up call” about the need to stop the spread of the SARS-CoV-2 virus among people and thus deprive it of opportunities to evolve its defenses, the top federal expert on infectious diseases said.

“The virus will continue to mutate and will mutate for its own selective advantage,” said Anthony S. Fauci, MD, director of the National Institute of Allergy and Infectious Diseases, at a Friday news conference organized by the White House.

The continued transmission of SARS-CoV-2 “gives the virus the chance to adapt to the forces, in this case the immune response, that’s trying to get rid of it,” Dr. Fauci said. “That’s where you get mutations.”

Federal health officials are working to boost the U.S. supply of COVID-19 vaccines, even as signals emerge about the extent that the virus is already evolving.

Data released this week about the Janssen/Johnson & Johnson (J&J) and Novavax COVID-19 vaccines in late-stage development provides further evidence that they may not protect as well against emerging variants, Dr. Fauci said.

“Mutations that lead to different lineage do have clinical consequences,” he said, while also emphasizing that the emerging vaccines appear to confer broad protection. Dr. Fauci earlier in the day addressed the “messaging challenge” for clinicians and researchers in discussing the results of the J&J vaccine trial, which appear to fall short of those reported for the two vaccines already approved and in use in the United States. He noted the benefits of possibly soon having more authorized vaccines to combat COVID-19. But continued community spread of the infection will foster conditions that can undermine the vaccines’ effectiveness.

“Even though the long-range effect in the sense of severe disease is still handled reasonably well by the vaccines, this is a wake-up call to all of us,” Dr. Fauci said.

Pharmaceutical scientists and executives and government health officials will need to work together to continue to develop vaccines that can outwit the emerging variants, he said.

On Jan. 29, J&J reported that its highly anticipated single-dose vaccine had shown its worst results in South Africa where many cases of COVID-19 were caused by infection with a SARS-CoV-2 variant from the B.1.351 lineage. The overall efficacy was 66% globally, 72% in the United States, and 57% in South Africa against moderate to severe SARS-CoV-2, J&J said.

Novavax on Jan. 28 reported an efficacy rate for its COVID-19 vaccine of 49.4% from a clinical trial conducted in South Africa, compared with an 89.3% rate from a U.K. study. There already have been attempts to estimate how well the Pfizer/BioNTech and Moderna vaccines can handle new variants of the virus. They both have been granted emergency-use authorization by the U.S. Food and Drug Administration.
 

‘Genomic surveillance’

The Centers for Disease Control and Prevention on Thursday reported the first U.S.-documented cases of the B.1.351 variant of SARS-CoV-2 in South Carolina. On Jan. 26, the first confirmed U.S. case of a highly transmissible Brazilian coronavirus variant was detected in Minnesota, state health officials said.

The CDC’s stepped-up “genomic surveillance” will help keep clinicians and researchers aware of how SARS-CoV-2 is changing, Dr. Fauci said.

Speaking at the same White House news conference, CDC director Rochelle Walensky, MD, MPH, said the two South Carolina cases of the B.1.351 variant were reported in different parts of the state and not believed to be epidemiologically linked. The people involved “did not have any travel history,” she added.

The SARS-CoV-2 mutations were expected to emerge at some point, as with any virus, but their appearance underscores the need for people to remain vigilant about precautions that can stop its spread, Dr. Walensky said.

She and Dr. Fauci both stressed the need for continued use of masks and social distancing and urged people to get COVID-19 vaccines as they become available. Continued community spread of the virus allows this global health threat to keep replicating, and thus increases its chances to thwart medical interventions, Dr. Fauci said.

“The virus has a playing field, as it were, to mutate,” Dr. Fauci said. “If you stop that and stop the replication, the viruses cannot mutate if they don’t replicate.”

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

Key clinical point: Increased prevalence for temporomandibular (TMD) pain is reported in individuals at risk for rheumatoid arthritis (RA). It is recommended to be alert to TMD pain disorders in such cases.

Major finding: The prevalence of TMD pain was higher in individuals at risk for RA vs. controls (P = .046). However, patients with early RA showed no difference in the prevalence of TMD pain vs. control individuals.

Study details: The data come from a cross-sectional study involving 50 individuals each with early RA, those at risk for RA, and controls.

Disclosures: The authors have not declared a specific grant for this research from any funding agency in the public, commercial, or not-for-profit sectors. The authors declared no conflicts of interest.

Source: Kroese JM et al. RMD Open. 2021 Jan 11. doi: 10.1136/rmdopen-2020-001485.

Key clinical point: Increased prevalence for temporomandibular (TMD) pain is reported in individuals at risk for rheumatoid arthritis (RA). It is recommended to be alert to TMD pain disorders in such cases.

Major finding: The prevalence of TMD pain was higher in individuals at risk for RA vs. controls (P = .046). However, patients with early RA showed no difference in the prevalence of TMD pain vs. control individuals.

Study details: The data come from a cross-sectional study involving 50 individuals each with early RA, those at risk for RA, and controls.

Disclosures: The authors have not declared a specific grant for this research from any funding agency in the public, commercial, or not-for-profit sectors. The authors declared no conflicts of interest.

Source: Kroese JM et al. RMD Open. 2021 Jan 11. doi: 10.1136/rmdopen-2020-001485.

Key clinical point: Increased prevalence for temporomandibular (TMD) pain is reported in individuals at risk for rheumatoid arthritis (RA). It is recommended to be alert to TMD pain disorders in such cases.

Major finding: The prevalence of TMD pain was higher in individuals at risk for RA vs. controls (P = .046). However, patients with early RA showed no difference in the prevalence of TMD pain vs. control individuals.

Study details: The data come from a cross-sectional study involving 50 individuals each with early RA, those at risk for RA, and controls.

Disclosures: The authors have not declared a specific grant for this research from any funding agency in the public, commercial, or not-for-profit sectors. The authors declared no conflicts of interest.

Source: Kroese JM et al. RMD Open. 2021 Jan 11. doi: 10.1136/rmdopen-2020-001485.

Emerging data support the clinical validity and use of DecisionDx-SCC as a prognostic 40-gene expression profile test for patients with high-risk squamous cell carcinoma (SCC), according to Anna A. Bar, MD.

“The incidence of SCC has been growing rapidly, and the disease-related mortality is actually more than that of melanoma,” Dr. Bar, associate professor of dermatology at Oregon Health & Science University, Portland, said during a virtual forum on cutaneous malignancies jointly presented by Postgraduate Institute for Medicine and Global Academy for Medical Education.

“Like many cancers, SCC management plans are guided by the risk of metastasis. The current staging systems, like NCCN, AJCC, or Brigham and Women’s systems, struggle to provide accurate data of the metastatic potential of an individual’s SCC,” she said. “Furthermore, the predictive accuracy of these systems in SCC is variable, and many patients who have high risk factors do not experience poor outcomes, while others initially classified as having less concerning tumors will go on to have metastatic disease. That is where new gene expression tests come into play.”

Developed by and commercially available from Castle Biosciences, DecisionDx-SCC classifies an individual SCC patient’s tumor into one of the categories: low (class 1), moderate (class 2A), or high (class 2B) biologic risk of metastasis. “We’re hoping that DecisionDx results can help make management decisions within established guidelines,” Dr. Bar said. The test is indicated for patients with high-risk features including tumor size greater than 2 cm; tumor location on the head, neck, hands, genitals, feet, or pretibial surface; immunosuppression; a rapidly growing tumor; a tumor with poorly defined borders; a tumor at the site of prior radiation or chronic inflammation; perineural invasion; poorly defined tumor grade, and a deep tumor beyond the subcutaneous fat.

One validity study and three clinical utility studies of DecisionDx-SCC have been published that include data from more than 1,100 patients (see Curr Med Res Opin. 2020 Aug;36[8]:1301-7; Curr Med Res Opin. 2020 Aug;36[8]:1295-1300, and J Drugs Dermatol. 2019 Oct 1;18[10]:980-4). “This is a work in progress,” said Dr. Bar, director of the university’s Mohs micrographic surgery and cutaneous oncology fellowship.

The test was validated in an another study, which was prospectively designed and used archival tissue from 33 independent academic and community centers, including Oregon Health & Science University. All 420 patients in the clinical validation study had one or more high-risk factors, meeting the definition of high risk by NCCN or Mohs Appropriate Use Criteria (AUC). Their mean age was 71 years, 73% were male, 99% were White, and 25% were immune deficient.

Of the 420 patients, 63 had metastasis, and 86% of metastases were located on the head and neck. About 30% of metastasized lesions had perineural involvement, 27% had invasion beyond subcutaneous fat, and metastasized lesions were about 1 cm wider compared with lesions that were not. The overall metastasis rate at 3 years was 15%, “which is similar to that seen in the medical literature for high-risk populations,” Dr. Bar said.

The median time to metastasis was 0.9 years and the 95th percentile was 2.7 years. “This means that the 3-year horizon for identifying events in this study enabled identification of most patients who eventually experienced metastatic events,” she said. In this cohort, approximately half of the metastatic events occurred around 11 months post diagnosis, which “may provide guidance about the timeline and duration of high-intensity follow-up with frequency of clinical visits and imaging for patients at highest risk within the first year.”

The positive predictive value of the DecisionDx-SCC is 52%, meaning that half of class 2B lesions will metastasize. “This compares favorably when you look at the lower positive predictive value of the other staging systems,” Dr. Bar said. “The negative predictive value is 93%, meaning there are not a lot of false negatives. This also compares favorably to the other staging systems.”

Kaplan-Meier analysis of metastasis-free survival showed strong separation between patients with class 1, class 2A, and class 2B results, Dr. Bar said. While the overall risk of metastasis in this patient cohort was 15%, the risk among those with a class 1 result was less than half of that. “Patients with a class 2A result behave similarly to those with traditional risk factors such as deep invasion and poor differentiation, having about a 20% risk of metastasis,” she said. “The class 2B result identifies the most worrisome SCCs, with a greater than 50% risk of metastasis. While the results distribution from routine clinical testing is not yet known, this large validation study of high-risk SCC revealed that approximately half of the patients were class 1, less than half were class 2A, and about 1 in 18 had a class 2B result.”

On univariate analyses with traditional risk factors and use of the Brigham and Women’s staging system, the hazard ratio (HR) for class 2A lesions was 3.2, “which is similar to deep invasion, poor differentiation, or perineural involvement,” Dr. Bar said. At the same time, the HR for class 2B lesions was 11.6, “so class 2B is the strongest predictor of metastasis. The class 2B HR remained statistically significant in the multivariate analysis and is three times higher than that of the next highest HR in this cohort. For example, a high-risk SCC with deep invasion is already two times more likely to metastasize. Adding a class 2B score would be over 14 times more likely to metastasize than a tumor with a class 1 result.”

DecisionDx-SCC test results can inform management decisions within established guidelines. For example, for a high-risk SCC patient who has a class 1 result, or low risk of metastasis, “you may proceed with surgery and clinical nodal exam, and then follow up a couple of times a year,” Dr. Bar said. “For a high-risk patient with a 2A or moderate risk result, you might proceed with surgical treatment plus consider imaging studies such as ultrasound, CT, PET CT, and consider referral to other specialties.”

For a high-risk patient with a 2B or high risk result, she continued, “you may want to proceed with imaging studies right away in addition to surgery and consider consultation with radiation oncology or medical oncology, as well as more frequent follow-up with nodal exams, because the class 2B patients have been shown to have a greater than 50% risk of metastasis.”

Global Academy for Medical Education and this news organization are owned by the same parent company.

Dr. Bar disclosed that Oregon Health & Science University has received research funding from Castle Biosciences.

[email protected]

Emerging data support the clinical validity and use of DecisionDx-SCC as a prognostic 40-gene expression profile test for patients with high-risk squamous cell carcinoma (SCC), according to Anna A. Bar, MD.

“The incidence of SCC has been growing rapidly, and the disease-related mortality is actually more than that of melanoma,” Dr. Bar, associate professor of dermatology at Oregon Health & Science University, Portland, said during a virtual forum on cutaneous malignancies jointly presented by Postgraduate Institute for Medicine and Global Academy for Medical Education.

“Like many cancers, SCC management plans are guided by the risk of metastasis. The current staging systems, like NCCN, AJCC, or Brigham and Women’s systems, struggle to provide accurate data of the metastatic potential of an individual’s SCC,” she said. “Furthermore, the predictive accuracy of these systems in SCC is variable, and many patients who have high risk factors do not experience poor outcomes, while others initially classified as having less concerning tumors will go on to have metastatic disease. That is where new gene expression tests come into play.”

Developed by and commercially available from Castle Biosciences, DecisionDx-SCC classifies an individual SCC patient’s tumor into one of the categories: low (class 1), moderate (class 2A), or high (class 2B) biologic risk of metastasis. “We’re hoping that DecisionDx results can help make management decisions within established guidelines,” Dr. Bar said. The test is indicated for patients with high-risk features including tumor size greater than 2 cm; tumor location on the head, neck, hands, genitals, feet, or pretibial surface; immunosuppression; a rapidly growing tumor; a tumor with poorly defined borders; a tumor at the site of prior radiation or chronic inflammation; perineural invasion; poorly defined tumor grade, and a deep tumor beyond the subcutaneous fat.

One validity study and three clinical utility studies of DecisionDx-SCC have been published that include data from more than 1,100 patients (see Curr Med Res Opin. 2020 Aug;36[8]:1301-7; Curr Med Res Opin. 2020 Aug;36[8]:1295-1300, and J Drugs Dermatol. 2019 Oct 1;18[10]:980-4). “This is a work in progress,” said Dr. Bar, director of the university’s Mohs micrographic surgery and cutaneous oncology fellowship.

The test was validated in an another study, which was prospectively designed and used archival tissue from 33 independent academic and community centers, including Oregon Health & Science University. All 420 patients in the clinical validation study had one or more high-risk factors, meeting the definition of high risk by NCCN or Mohs Appropriate Use Criteria (AUC). Their mean age was 71 years, 73% were male, 99% were White, and 25% were immune deficient.

Of the 420 patients, 63 had metastasis, and 86% of metastases were located on the head and neck. About 30% of metastasized lesions had perineural involvement, 27% had invasion beyond subcutaneous fat, and metastasized lesions were about 1 cm wider compared with lesions that were not. The overall metastasis rate at 3 years was 15%, “which is similar to that seen in the medical literature for high-risk populations,” Dr. Bar said.

The median time to metastasis was 0.9 years and the 95th percentile was 2.7 years. “This means that the 3-year horizon for identifying events in this study enabled identification of most patients who eventually experienced metastatic events,” she said. In this cohort, approximately half of the metastatic events occurred around 11 months post diagnosis, which “may provide guidance about the timeline and duration of high-intensity follow-up with frequency of clinical visits and imaging for patients at highest risk within the first year.”

The positive predictive value of the DecisionDx-SCC is 52%, meaning that half of class 2B lesions will metastasize. “This compares favorably when you look at the lower positive predictive value of the other staging systems,” Dr. Bar said. “The negative predictive value is 93%, meaning there are not a lot of false negatives. This also compares favorably to the other staging systems.”

Kaplan-Meier analysis of metastasis-free survival showed strong separation between patients with class 1, class 2A, and class 2B results, Dr. Bar said. While the overall risk of metastasis in this patient cohort was 15%, the risk among those with a class 1 result was less than half of that. “Patients with a class 2A result behave similarly to those with traditional risk factors such as deep invasion and poor differentiation, having about a 20% risk of metastasis,” she said. “The class 2B result identifies the most worrisome SCCs, with a greater than 50% risk of metastasis. While the results distribution from routine clinical testing is not yet known, this large validation study of high-risk SCC revealed that approximately half of the patients were class 1, less than half were class 2A, and about 1 in 18 had a class 2B result.”

On univariate analyses with traditional risk factors and use of the Brigham and Women’s staging system, the hazard ratio (HR) for class 2A lesions was 3.2, “which is similar to deep invasion, poor differentiation, or perineural involvement,” Dr. Bar said. At the same time, the HR for class 2B lesions was 11.6, “so class 2B is the strongest predictor of metastasis. The class 2B HR remained statistically significant in the multivariate analysis and is three times higher than that of the next highest HR in this cohort. For example, a high-risk SCC with deep invasion is already two times more likely to metastasize. Adding a class 2B score would be over 14 times more likely to metastasize than a tumor with a class 1 result.”

DecisionDx-SCC test results can inform management decisions within established guidelines. For example, for a high-risk SCC patient who has a class 1 result, or low risk of metastasis, “you may proceed with surgery and clinical nodal exam, and then follow up a couple of times a year,” Dr. Bar said. “For a high-risk patient with a 2A or moderate risk result, you might proceed with surgical treatment plus consider imaging studies such as ultrasound, CT, PET CT, and consider referral to other specialties.”

For a high-risk patient with a 2B or high risk result, she continued, “you may want to proceed with imaging studies right away in addition to surgery and consider consultation with radiation oncology or medical oncology, as well as more frequent follow-up with nodal exams, because the class 2B patients have been shown to have a greater than 50% risk of metastasis.”

Global Academy for Medical Education and this news organization are owned by the same parent company.

Dr. Bar disclosed that Oregon Health & Science University has received research funding from Castle Biosciences.

[email protected]

Emerging data support the clinical validity and use of DecisionDx-SCC as a prognostic 40-gene expression profile test for patients with high-risk squamous cell carcinoma (SCC), according to Anna A. Bar, MD.

“The incidence of SCC has been growing rapidly, and the disease-related mortality is actually more than that of melanoma,” Dr. Bar, associate professor of dermatology at Oregon Health & Science University, Portland, said during a virtual forum on cutaneous malignancies jointly presented by Postgraduate Institute for Medicine and Global Academy for Medical Education.

“Like many cancers, SCC management plans are guided by the risk of metastasis. The current staging systems, like NCCN, AJCC, or Brigham and Women’s systems, struggle to provide accurate data of the metastatic potential of an individual’s SCC,” she said. “Furthermore, the predictive accuracy of these systems in SCC is variable, and many patients who have high risk factors do not experience poor outcomes, while others initially classified as having less concerning tumors will go on to have metastatic disease. That is where new gene expression tests come into play.”

Developed by and commercially available from Castle Biosciences, DecisionDx-SCC classifies an individual SCC patient’s tumor into one of the categories: low (class 1), moderate (class 2A), or high (class 2B) biologic risk of metastasis. “We’re hoping that DecisionDx results can help make management decisions within established guidelines,” Dr. Bar said. The test is indicated for patients with high-risk features including tumor size greater than 2 cm; tumor location on the head, neck, hands, genitals, feet, or pretibial surface; immunosuppression; a rapidly growing tumor; a tumor with poorly defined borders; a tumor at the site of prior radiation or chronic inflammation; perineural invasion; poorly defined tumor grade, and a deep tumor beyond the subcutaneous fat.

One validity study and three clinical utility studies of DecisionDx-SCC have been published that include data from more than 1,100 patients (see Curr Med Res Opin. 2020 Aug;36[8]:1301-7; Curr Med Res Opin. 2020 Aug;36[8]:1295-1300, and J Drugs Dermatol. 2019 Oct 1;18[10]:980-4). “This is a work in progress,” said Dr. Bar, director of the university’s Mohs micrographic surgery and cutaneous oncology fellowship.

The test was validated in an another study, which was prospectively designed and used archival tissue from 33 independent academic and community centers, including Oregon Health & Science University. All 420 patients in the clinical validation study had one or more high-risk factors, meeting the definition of high risk by NCCN or Mohs Appropriate Use Criteria (AUC). Their mean age was 71 years, 73% were male, 99% were White, and 25% were immune deficient.

Of the 420 patients, 63 had metastasis, and 86% of metastases were located on the head and neck. About 30% of metastasized lesions had perineural involvement, 27% had invasion beyond subcutaneous fat, and metastasized lesions were about 1 cm wider compared with lesions that were not. The overall metastasis rate at 3 years was 15%, “which is similar to that seen in the medical literature for high-risk populations,” Dr. Bar said.

The median time to metastasis was 0.9 years and the 95th percentile was 2.7 years. “This means that the 3-year horizon for identifying events in this study enabled identification of most patients who eventually experienced metastatic events,” she said. In this cohort, approximately half of the metastatic events occurred around 11 months post diagnosis, which “may provide guidance about the timeline and duration of high-intensity follow-up with frequency of clinical visits and imaging for patients at highest risk within the first year.”

The positive predictive value of the DecisionDx-SCC is 52%, meaning that half of class 2B lesions will metastasize. “This compares favorably when you look at the lower positive predictive value of the other staging systems,” Dr. Bar said. “The negative predictive value is 93%, meaning there are not a lot of false negatives. This also compares favorably to the other staging systems.”

Kaplan-Meier analysis of metastasis-free survival showed strong separation between patients with class 1, class 2A, and class 2B results, Dr. Bar said. While the overall risk of metastasis in this patient cohort was 15%, the risk among those with a class 1 result was less than half of that. “Patients with a class 2A result behave similarly to those with traditional risk factors such as deep invasion and poor differentiation, having about a 20% risk of metastasis,” she said. “The class 2B result identifies the most worrisome SCCs, with a greater than 50% risk of metastasis. While the results distribution from routine clinical testing is not yet known, this large validation study of high-risk SCC revealed that approximately half of the patients were class 1, less than half were class 2A, and about 1 in 18 had a class 2B result.”

On univariate analyses with traditional risk factors and use of the Brigham and Women’s staging system, the hazard ratio (HR) for class 2A lesions was 3.2, “which is similar to deep invasion, poor differentiation, or perineural involvement,” Dr. Bar said. At the same time, the HR for class 2B lesions was 11.6, “so class 2B is the strongest predictor of metastasis. The class 2B HR remained statistically significant in the multivariate analysis and is three times higher than that of the next highest HR in this cohort. For example, a high-risk SCC with deep invasion is already two times more likely to metastasize. Adding a class 2B score would be over 14 times more likely to metastasize than a tumor with a class 1 result.”

DecisionDx-SCC test results can inform management decisions within established guidelines. For example, for a high-risk SCC patient who has a class 1 result, or low risk of metastasis, “you may proceed with surgery and clinical nodal exam, and then follow up a couple of times a year,” Dr. Bar said. “For a high-risk patient with a 2A or moderate risk result, you might proceed with surgical treatment plus consider imaging studies such as ultrasound, CT, PET CT, and consider referral to other specialties.”

For a high-risk patient with a 2B or high risk result, she continued, “you may want to proceed with imaging studies right away in addition to surgery and consider consultation with radiation oncology or medical oncology, as well as more frequent follow-up with nodal exams, because the class 2B patients have been shown to have a greater than 50% risk of metastasis.”

Global Academy for Medical Education and this news organization are owned by the same parent company.

Dr. Bar disclosed that Oregon Health & Science University has received research funding from Castle Biosciences.

[email protected]

Key clinical point: Treat-to-target strategy (T2T) was associated with higher probability of achieving the treatment target in patients with rheumatoid arthritis (RA) who could not reach treatment target within 6 months.

Major finding: RA patients following T2T had a 2.8 times higher likelihood for remission/low disease activity at 12 months than those not following the T2T strategy (P = .005).

Study details: Data from ATTRA registry were assessed. Seventy-five patients with RA following T2T were matched with 75 patients who continued initial treatment despite not reaching the treatment target within 6 months.

Disclosures: The work was supported by the project (Ministry of Health, Czech Republic) for conceptual development of research organization (Institute of

Rheumatology). The authors declared no conflicts of interest.

Source: Nekvindová L et al. Arthritis Res Ther. 2021 Jan 6. doi: 10.1186/s13075-020-02393-8.

Key clinical point: Treat-to-target strategy (T2T) was associated with higher probability of achieving the treatment target in patients with rheumatoid arthritis (RA) who could not reach treatment target within 6 months.

Major finding: RA patients following T2T had a 2.8 times higher likelihood for remission/low disease activity at 12 months than those not following the T2T strategy (P = .005).

Study details: Data from ATTRA registry were assessed. Seventy-five patients with RA following T2T were matched with 75 patients who continued initial treatment despite not reaching the treatment target within 6 months.

Disclosures: The work was supported by the project (Ministry of Health, Czech Republic) for conceptual development of research organization (Institute of

Rheumatology). The authors declared no conflicts of interest.

Source: Nekvindová L et al. Arthritis Res Ther. 2021 Jan 6. doi: 10.1186/s13075-020-02393-8.

Key clinical point: Treat-to-target strategy (T2T) was associated with higher probability of achieving the treatment target in patients with rheumatoid arthritis (RA) who could not reach treatment target within 6 months.

Major finding: RA patients following T2T had a 2.8 times higher likelihood for remission/low disease activity at 12 months than those not following the T2T strategy (P = .005).

Study details: Data from ATTRA registry were assessed. Seventy-five patients with RA following T2T were matched with 75 patients who continued initial treatment despite not reaching the treatment target within 6 months.

Disclosures: The work was supported by the project (Ministry of Health, Czech Republic) for conceptual development of research organization (Institute of

Rheumatology). The authors declared no conflicts of interest.

Source: Nekvindová L et al. Arthritis Res Ther. 2021 Jan 6. doi: 10.1186/s13075-020-02393-8.

An international team of researchers studying COVID-19 has made a startling and pivotal discovery: The virus appears to cause the body to make weapons to attack its own tissues.

The finding could unlock a number of COVID-19’s clinical mysteries. They include the puzzling collection of symptoms that can come with the infection; the persistence of symptoms in some people for months after they clear the virus, a phenomenon dubbed long COVID-19; and why some children and adults have a serious inflammatory syndrome, called multisystem inflammatory syndrome in children (MIS-C) or MIS in adults (MIS-A), after their infections.

“It suggests that the virus might be directly causing autoimmunity, which would be fascinating,” says lead study author Paul Utz, MD, who studies immunology and autoimmunity at Stanford (Calif.) University.

The study also deepens the question of whether other respiratory viruses might also break the body’s tolerance to itself, setting people up for autoimmune diseases like multiple sclerosis, rheumatoid arthritis, and lupus later in life.

Dr. Utz said he and his team are next going to study flu patients to see if that virus might also cause this phenomenon.

“My prediction is that it isn’t going to be specific just to SARS-CoV-2. I’m willing to bet that we will find this with other respiratory viruses,” he said.

The study comes on the heels of a handful of smaller, detailed investigations that have come to similar conclusions.

The study included data from more than 300 patients from four hospitals: two in California, one in Pennsylvania, and another in Germany.

Researchers used blood tests to study their immune responses as their infections progressed. Researchers looked for autoantibodies – weapons of the immune system that go rogue and launch an attack against the body’s own tissues. They compared these autoantibodies with those found in people who were not infected with the virus that causes COVID.

As previous studies have found, autoantibodies were more common after COVID – 50% of people hospitalized for their infections had autoantibodies, compared with less than 15% of those who were healthy and uninfected.

Some people with autoantibodies had little change in them as their infections progressed. That suggests the autoantibodies were there to begin with, possibly allowing the infection to burn out of control in the body.

“Their body is set up to get bad COVID, and it’s probably caused by the autoantibodies,” Dr. Utz said.

But in others, about 20% of people who had them, the autoantibodies became more common as the infection progressed, suggesting they were directly related to the viral infection, instead of being a preexisting condition.

Some of these were antibodies that attack key components of the immune system’s weapons against the virus, like interferon. Interferons are proteins that help infected cells call for reinforcements and can also interfere with a virus’s ability to copy itself. Taking them out is a powerful evasive tactic, and previous studies have shown that people who are born with genes that cause them to have lower interferon function, or who make autoantibodies against these proteins, appear to be at higher risk for life-threatening COVID infections.

“It seems to give the virus a powerful advantage,” said study author, John Wherry, PhD, who directs the Institute for Immunology at the University of Pennsylvania, Philadelphia. “Now your immune system, instead of having a tiny little hill to climb, is staring at Mount Everest. That really is devious.”

In addition to those that sabotage the immune system, some people in the study had autoantibodies against muscles and connective tissues that are seen in some rare disorders.

Dr. Utz said they started the study after seeing COVID patients with strange collections of symptoms that looked more like autoimmune diseases than viral infections – skin rashes, joint pain, fatigue, aching muscles, brain swelling, dry eyes, blood that clots easily, and inflamed blood vessels.

“One thing that’s very important to note is that we don’t know if these patients are going to go on to develop autoimmune disease,” Dr. Utz said. “I think we’ll be able to answer that question in the next 6-12 months as we follow the long haulers and study their samples.”

Dr. Utz said it will be important to study autoantibodies in long haulers to see if they can identify exactly which ones seem to be at work in the condition. If you can catch them early, it might be possible to treat those at risk for enduring symptoms with drugs that suppress the immune system.

What this means, he said, is that COVID will be with us for a long, long time.

“We have to realize that there’s going to be long-term damage from this virus for the survivors. Not just the long haulers, but all the people who have lung damage and heart damage and everything else. We’re going to be studying this virus and it’s badness for decades,” Dr. Utz said.

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

An international team of researchers studying COVID-19 has made a startling and pivotal discovery: The virus appears to cause the body to make weapons to attack its own tissues.

The finding could unlock a number of COVID-19’s clinical mysteries. They include the puzzling collection of symptoms that can come with the infection; the persistence of symptoms in some people for months after they clear the virus, a phenomenon dubbed long COVID-19; and why some children and adults have a serious inflammatory syndrome, called multisystem inflammatory syndrome in children (MIS-C) or MIS in adults (MIS-A), after their infections.

“It suggests that the virus might be directly causing autoimmunity, which would be fascinating,” says lead study author Paul Utz, MD, who studies immunology and autoimmunity at Stanford (Calif.) University.

The study also deepens the question of whether other respiratory viruses might also break the body’s tolerance to itself, setting people up for autoimmune diseases like multiple sclerosis, rheumatoid arthritis, and lupus later in life.

Dr. Utz said he and his team are next going to study flu patients to see if that virus might also cause this phenomenon.

“My prediction is that it isn’t going to be specific just to SARS-CoV-2. I’m willing to bet that we will find this with other respiratory viruses,” he said.

The study comes on the heels of a handful of smaller, detailed investigations that have come to similar conclusions.

The study included data from more than 300 patients from four hospitals: two in California, one in Pennsylvania, and another in Germany.

Researchers used blood tests to study their immune responses as their infections progressed. Researchers looked for autoantibodies – weapons of the immune system that go rogue and launch an attack against the body’s own tissues. They compared these autoantibodies with those found in people who were not infected with the virus that causes COVID.

As previous studies have found, autoantibodies were more common after COVID – 50% of people hospitalized for their infections had autoantibodies, compared with less than 15% of those who were healthy and uninfected.

Some people with autoantibodies had little change in them as their infections progressed. That suggests the autoantibodies were there to begin with, possibly allowing the infection to burn out of control in the body.

“Their body is set up to get bad COVID, and it’s probably caused by the autoantibodies,” Dr. Utz said.

But in others, about 20% of people who had them, the autoantibodies became more common as the infection progressed, suggesting they were directly related to the viral infection, instead of being a preexisting condition.

Some of these were antibodies that attack key components of the immune system’s weapons against the virus, like interferon. Interferons are proteins that help infected cells call for reinforcements and can also interfere with a virus’s ability to copy itself. Taking them out is a powerful evasive tactic, and previous studies have shown that people who are born with genes that cause them to have lower interferon function, or who make autoantibodies against these proteins, appear to be at higher risk for life-threatening COVID infections.

“It seems to give the virus a powerful advantage,” said study author, John Wherry, PhD, who directs the Institute for Immunology at the University of Pennsylvania, Philadelphia. “Now your immune system, instead of having a tiny little hill to climb, is staring at Mount Everest. That really is devious.”

In addition to those that sabotage the immune system, some people in the study had autoantibodies against muscles and connective tissues that are seen in some rare disorders.

Dr. Utz said they started the study after seeing COVID patients with strange collections of symptoms that looked more like autoimmune diseases than viral infections – skin rashes, joint pain, fatigue, aching muscles, brain swelling, dry eyes, blood that clots easily, and inflamed blood vessels.

“One thing that’s very important to note is that we don’t know if these patients are going to go on to develop autoimmune disease,” Dr. Utz said. “I think we’ll be able to answer that question in the next 6-12 months as we follow the long haulers and study their samples.”

Dr. Utz said it will be important to study autoantibodies in long haulers to see if they can identify exactly which ones seem to be at work in the condition. If you can catch them early, it might be possible to treat those at risk for enduring symptoms with drugs that suppress the immune system.

What this means, he said, is that COVID will be with us for a long, long time.

“We have to realize that there’s going to be long-term damage from this virus for the survivors. Not just the long haulers, but all the people who have lung damage and heart damage and everything else. We’re going to be studying this virus and it’s badness for decades,” Dr. Utz said.

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

An international team of researchers studying COVID-19 has made a startling and pivotal discovery: The virus appears to cause the body to make weapons to attack its own tissues.

The finding could unlock a number of COVID-19’s clinical mysteries. They include the puzzling collection of symptoms that can come with the infection; the persistence of symptoms in some people for months after they clear the virus, a phenomenon dubbed long COVID-19; and why some children and adults have a serious inflammatory syndrome, called multisystem inflammatory syndrome in children (MIS-C) or MIS in adults (MIS-A), after their infections.

“It suggests that the virus might be directly causing autoimmunity, which would be fascinating,” says lead study author Paul Utz, MD, who studies immunology and autoimmunity at Stanford (Calif.) University.

The study also deepens the question of whether other respiratory viruses might also break the body’s tolerance to itself, setting people up for autoimmune diseases like multiple sclerosis, rheumatoid arthritis, and lupus later in life.

Dr. Utz said he and his team are next going to study flu patients to see if that virus might also cause this phenomenon.

“My prediction is that it isn’t going to be specific just to SARS-CoV-2. I’m willing to bet that we will find this with other respiratory viruses,” he said.

The study comes on the heels of a handful of smaller, detailed investigations that have come to similar conclusions.

The study included data from more than 300 patients from four hospitals: two in California, one in Pennsylvania, and another in Germany.

Researchers used blood tests to study their immune responses as their infections progressed. Researchers looked for autoantibodies – weapons of the immune system that go rogue and launch an attack against the body’s own tissues. They compared these autoantibodies with those found in people who were not infected with the virus that causes COVID.

As previous studies have found, autoantibodies were more common after COVID – 50% of people hospitalized for their infections had autoantibodies, compared with less than 15% of those who were healthy and uninfected.

Some people with autoantibodies had little change in them as their infections progressed. That suggests the autoantibodies were there to begin with, possibly allowing the infection to burn out of control in the body.

“Their body is set up to get bad COVID, and it’s probably caused by the autoantibodies,” Dr. Utz said.

But in others, about 20% of people who had them, the autoantibodies became more common as the infection progressed, suggesting they were directly related to the viral infection, instead of being a preexisting condition.

Some of these were antibodies that attack key components of the immune system’s weapons against the virus, like interferon. Interferons are proteins that help infected cells call for reinforcements and can also interfere with a virus’s ability to copy itself. Taking them out is a powerful evasive tactic, and previous studies have shown that people who are born with genes that cause them to have lower interferon function, or who make autoantibodies against these proteins, appear to be at higher risk for life-threatening COVID infections.

“It seems to give the virus a powerful advantage,” said study author, John Wherry, PhD, who directs the Institute for Immunology at the University of Pennsylvania, Philadelphia. “Now your immune system, instead of having a tiny little hill to climb, is staring at Mount Everest. That really is devious.”

In addition to those that sabotage the immune system, some people in the study had autoantibodies against muscles and connective tissues that are seen in some rare disorders.

Dr. Utz said they started the study after seeing COVID patients with strange collections of symptoms that looked more like autoimmune diseases than viral infections – skin rashes, joint pain, fatigue, aching muscles, brain swelling, dry eyes, blood that clots easily, and inflamed blood vessels.

“One thing that’s very important to note is that we don’t know if these patients are going to go on to develop autoimmune disease,” Dr. Utz said. “I think we’ll be able to answer that question in the next 6-12 months as we follow the long haulers and study their samples.”

Dr. Utz said it will be important to study autoantibodies in long haulers to see if they can identify exactly which ones seem to be at work in the condition. If you can catch them early, it might be possible to treat those at risk for enduring symptoms with drugs that suppress the immune system.

What this means, he said, is that COVID will be with us for a long, long time.

“We have to realize that there’s going to be long-term damage from this virus for the survivors. Not just the long haulers, but all the people who have lung damage and heart damage and everything else. We’re going to be studying this virus and it’s badness for decades,” Dr. Utz said.

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