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Ivermectin does not stop progression to severe COVID: randomized trial
Ivermectin treatment given to high-risk patients with mild-to-moderate COVID-19 during the first week of illness did not prevent progression to severe disease, according to results from a randomized clinical trial.
“The study findings do not support the use of ivermectin for patients with COVID-19,” researchers conclude in the paper published online in JAMA Internal Medicine.
The open-label trial was conducted at 20 public hospitals and a COVID-19 quarantine center in Malaysia between May 31 and Oct. 25, 2021. It was led by Steven Chee Loon Lim, MRCP, department of medicine, Raja Permaisuri Bainun Hospital, Perak, Malaysia.
Among 490 patients in the primary analysis, 52 of 241 patients (21.6%) in the ivermectin group and 43 of 249 patients (17.3%) in the control group progressed to severe disease (relative risk, 1.25; 95% confidence interval, 0.87-1.80; P = .25). All major ethnic groups in Malaysia were well represented, the researchers write.
Participants (average age 62.5 and 54.5% women) were randomly assigned 1:1 to receive either a 5-day course of oral ivermectin (0.4 mg/kg body weight daily for 5 days) plus standard of care (n = 241) or standard of care alone (n = 249). Standard of care included symptomatic therapy and monitoring for early deterioration based on clinical findings, laboratory tests, and chest imaging.
Secondary outcomes
Secondary outcomes included rates of mechanical ventilation, intensive care unit (ICU) admission, 28-day in-hospital mortality, and side effects.
In all the secondary outcomes, there were no significant differences between groups.
Mechanical ventilation occurred in four patients on the ivermectin protocol (1.7%) versus 10 patients in the control group (4.0%) (RR, 0.41; 95% CI, 0.13-1.30; P = .17); ICU admission occurred in six (2.4%) versus eight (3.2%) (RR, 0.78; 95% CI, 0.27-2.20; P = .79); and 28-day in-hospital death occurred in three (1.2%) versus 10 (4.0%) (RR, 0.31; 95% CI, 0.09-1.11; P = .09).
The most common adverse event was diarrhea, reported by 5.8% in the ivermectin group and 1.6% in the control group.
No difference by vaccine status
The researchers conducted a subgroup analysis to evaluate any differences in whether participants were vaccinated. They said that analysis was “unremarkable.”
Just more than half of participants (51.8%) were fully vaccinated, with two doses of COVID-19 vaccines. Among the fully vaccinated patients, 17.7% in the ivermectin group and 9.2% in the control group developed severe disease (RR, 1.92; 95% CI, 0.99-3.71; P = .06).
Ivermectin, an inexpensive and widely available antiparasitic drug, is prescribed to treat COVID-19 but has not been approved by the U.S. Food and Drug Administration for that purpose. Evidence-based data for or against use has been sparse.
The authors write that “although some early clinical studies suggested the potential efficacy of ivermectin in the treatment and prevention of COVID-19, these studies had methodologic weaknesses.”
Dr. Lim and colleagues point out that their findings are consistent with those of the IVERCOR-COVID19 trial, which found ivermectin ineffective in reducing hospitalization risk.
Previous randomized trials of ivermectin for COVID-19 patients that have included at least 400 patients have focused on outpatients.
In the current study, the authors note, patients were hospitalized, which allowed investigators to observe administration of ivermectin with a high adherence rate. Additionally, the researchers used clearly defined criteria for determining progression to severe disease.
Limitations of the current study include that the open-label design might lead to under-reporting of adverse events in the control group while overestimating the drug effects of ivermectin. The study was also not designed to assess the effects of ivermectin on mortality from COVID-19.
A version of this article first appeared on Medscape.com.
Ivermectin treatment given to high-risk patients with mild-to-moderate COVID-19 during the first week of illness did not prevent progression to severe disease, according to results from a randomized clinical trial.
“The study findings do not support the use of ivermectin for patients with COVID-19,” researchers conclude in the paper published online in JAMA Internal Medicine.
The open-label trial was conducted at 20 public hospitals and a COVID-19 quarantine center in Malaysia between May 31 and Oct. 25, 2021. It was led by Steven Chee Loon Lim, MRCP, department of medicine, Raja Permaisuri Bainun Hospital, Perak, Malaysia.
Among 490 patients in the primary analysis, 52 of 241 patients (21.6%) in the ivermectin group and 43 of 249 patients (17.3%) in the control group progressed to severe disease (relative risk, 1.25; 95% confidence interval, 0.87-1.80; P = .25). All major ethnic groups in Malaysia were well represented, the researchers write.
Participants (average age 62.5 and 54.5% women) were randomly assigned 1:1 to receive either a 5-day course of oral ivermectin (0.4 mg/kg body weight daily for 5 days) plus standard of care (n = 241) or standard of care alone (n = 249). Standard of care included symptomatic therapy and monitoring for early deterioration based on clinical findings, laboratory tests, and chest imaging.
Secondary outcomes
Secondary outcomes included rates of mechanical ventilation, intensive care unit (ICU) admission, 28-day in-hospital mortality, and side effects.
In all the secondary outcomes, there were no significant differences between groups.
Mechanical ventilation occurred in four patients on the ivermectin protocol (1.7%) versus 10 patients in the control group (4.0%) (RR, 0.41; 95% CI, 0.13-1.30; P = .17); ICU admission occurred in six (2.4%) versus eight (3.2%) (RR, 0.78; 95% CI, 0.27-2.20; P = .79); and 28-day in-hospital death occurred in three (1.2%) versus 10 (4.0%) (RR, 0.31; 95% CI, 0.09-1.11; P = .09).
The most common adverse event was diarrhea, reported by 5.8% in the ivermectin group and 1.6% in the control group.
No difference by vaccine status
The researchers conducted a subgroup analysis to evaluate any differences in whether participants were vaccinated. They said that analysis was “unremarkable.”
Just more than half of participants (51.8%) were fully vaccinated, with two doses of COVID-19 vaccines. Among the fully vaccinated patients, 17.7% in the ivermectin group and 9.2% in the control group developed severe disease (RR, 1.92; 95% CI, 0.99-3.71; P = .06).
Ivermectin, an inexpensive and widely available antiparasitic drug, is prescribed to treat COVID-19 but has not been approved by the U.S. Food and Drug Administration for that purpose. Evidence-based data for or against use has been sparse.
The authors write that “although some early clinical studies suggested the potential efficacy of ivermectin in the treatment and prevention of COVID-19, these studies had methodologic weaknesses.”
Dr. Lim and colleagues point out that their findings are consistent with those of the IVERCOR-COVID19 trial, which found ivermectin ineffective in reducing hospitalization risk.
Previous randomized trials of ivermectin for COVID-19 patients that have included at least 400 patients have focused on outpatients.
In the current study, the authors note, patients were hospitalized, which allowed investigators to observe administration of ivermectin with a high adherence rate. Additionally, the researchers used clearly defined criteria for determining progression to severe disease.
Limitations of the current study include that the open-label design might lead to under-reporting of adverse events in the control group while overestimating the drug effects of ivermectin. The study was also not designed to assess the effects of ivermectin on mortality from COVID-19.
A version of this article first appeared on Medscape.com.
Ivermectin treatment given to high-risk patients with mild-to-moderate COVID-19 during the first week of illness did not prevent progression to severe disease, according to results from a randomized clinical trial.
“The study findings do not support the use of ivermectin for patients with COVID-19,” researchers conclude in the paper published online in JAMA Internal Medicine.
The open-label trial was conducted at 20 public hospitals and a COVID-19 quarantine center in Malaysia between May 31 and Oct. 25, 2021. It was led by Steven Chee Loon Lim, MRCP, department of medicine, Raja Permaisuri Bainun Hospital, Perak, Malaysia.
Among 490 patients in the primary analysis, 52 of 241 patients (21.6%) in the ivermectin group and 43 of 249 patients (17.3%) in the control group progressed to severe disease (relative risk, 1.25; 95% confidence interval, 0.87-1.80; P = .25). All major ethnic groups in Malaysia were well represented, the researchers write.
Participants (average age 62.5 and 54.5% women) were randomly assigned 1:1 to receive either a 5-day course of oral ivermectin (0.4 mg/kg body weight daily for 5 days) plus standard of care (n = 241) or standard of care alone (n = 249). Standard of care included symptomatic therapy and monitoring for early deterioration based on clinical findings, laboratory tests, and chest imaging.
Secondary outcomes
Secondary outcomes included rates of mechanical ventilation, intensive care unit (ICU) admission, 28-day in-hospital mortality, and side effects.
In all the secondary outcomes, there were no significant differences between groups.
Mechanical ventilation occurred in four patients on the ivermectin protocol (1.7%) versus 10 patients in the control group (4.0%) (RR, 0.41; 95% CI, 0.13-1.30; P = .17); ICU admission occurred in six (2.4%) versus eight (3.2%) (RR, 0.78; 95% CI, 0.27-2.20; P = .79); and 28-day in-hospital death occurred in three (1.2%) versus 10 (4.0%) (RR, 0.31; 95% CI, 0.09-1.11; P = .09).
The most common adverse event was diarrhea, reported by 5.8% in the ivermectin group and 1.6% in the control group.
No difference by vaccine status
The researchers conducted a subgroup analysis to evaluate any differences in whether participants were vaccinated. They said that analysis was “unremarkable.”
Just more than half of participants (51.8%) were fully vaccinated, with two doses of COVID-19 vaccines. Among the fully vaccinated patients, 17.7% in the ivermectin group and 9.2% in the control group developed severe disease (RR, 1.92; 95% CI, 0.99-3.71; P = .06).
Ivermectin, an inexpensive and widely available antiparasitic drug, is prescribed to treat COVID-19 but has not been approved by the U.S. Food and Drug Administration for that purpose. Evidence-based data for or against use has been sparse.
The authors write that “although some early clinical studies suggested the potential efficacy of ivermectin in the treatment and prevention of COVID-19, these studies had methodologic weaknesses.”
Dr. Lim and colleagues point out that their findings are consistent with those of the IVERCOR-COVID19 trial, which found ivermectin ineffective in reducing hospitalization risk.
Previous randomized trials of ivermectin for COVID-19 patients that have included at least 400 patients have focused on outpatients.
In the current study, the authors note, patients were hospitalized, which allowed investigators to observe administration of ivermectin with a high adherence rate. Additionally, the researchers used clearly defined criteria for determining progression to severe disease.
Limitations of the current study include that the open-label design might lead to under-reporting of adverse events in the control group while overestimating the drug effects of ivermectin. The study was also not designed to assess the effects of ivermectin on mortality from COVID-19.
A version of this article first appeared on Medscape.com.
FROM JAMA INTERNAL MEDICNE
New ivermectin, HCQ scripts highest in GOP-dominated counties
New prescriptions of hydroxychloroquine (HCQ) and ivermectin increased in 2020, driven particularly by rates in counties with the highest proportion of Republican votes in the 2020 U.S. presidential election, according to a cross-sectional study published in JAMA Internal Medicine.
“Our findings are consistent with the hypothesis that U.S. prescribing of hydroxychloroquine and ivermectin during the COVID-19 pandemic may have been influenced by political affiliation,” wrote Michael L. Barnett, MD, of the Harvard T.H. Chan School of Public Health in Boston and colleagues.
The researchers used data from the OptumLabs Data Warehouse to analyze commercial and Medicare Advantage medical claims from January 2019 through December 2020 for more than 18.5 million adults living in counties with at least 50 enrollees.
Using U.S. Census data and 2020 presidential election results, the researchers classified counties according to their proportion of Republican voters and then examined whether those proportions were associated with that county’s rates of new prescriptions for HCQ, ivermectin, methotrexate sodium, and albendazole. Methotrexate is prescribed for similar conditions and indications as HCQ, and albendazole is prescribed for similar reasons as ivermectin, although neither of the comparison drugs has been considered for COVID-19 treatment.
The Food and Drug Administration issued an emergency use authorization (EUA) for HCQ as a COVID-19 treatment on March 28, 2020, but the agency revoked the EUA 3 months later on June 15. Ivermectin never received an EUA for COVID treatment, but an in vitro study published April 3, 2020 claimed it had an antiviral effect.
The National Institutes of Health recommended against using ivermectin as a COVID-19 treatment on Aug. 1, 2020, but a few months later, on Nov. 13, a flawed clinical trial – later retracted – claimed ivermectin was 90% effective in treating COVID-19. Despite the lack of evidence for ivermectin’s efficacy, a Senate committee meeting on Dec. 8, 2020, included testimony from a physician who promoted its use.
In comparing ivermectin and HCQ prescription rates with counties’ political composition, the researchers adjusted their findings to account for differences in the counties’ racial composition and COVID-19 incidence as well as enrollees’ age, sex, insurance type, income, comorbidity burden, and home in a rural or urban area.
The results showed an average of 20 new HCQ prescriptions per 100,000 enrollees in 2019, but 2020 saw a sharp increase and drop in new HCQ prescriptions in March-April 2020, independent of counties’ breakdown of political affiliation.
“However, after June 2020, coinciding with the revocation of the U.S. Food and Drug Administration’s emergency use authorization for hydroxychloroquine, prescribing volume was significantly higher in the highest vs. lowest Republican vote share counties,” the authors report. The gradual increase from June through December 2020 averaged to 42 new prescriptions per 100,000, a 146% increase over 2019 rates that was driven largely by the 25% of counties with the highest proportion of Republican voters.
Similarly, rates of new ivermectin prescriptions in December 2020 were more than nine times higher in counties with the highest Republican vote share, compared with new prescriptions throughout 2019. The researchers found no differences in new prescriptions for methotrexate or albendazole in 2020 based on counties’ proportion of Republican votes.
Since the study is an ecological, observational one, it cannot show causation or shed light on what role patients, physicians, or other factors might have played in prescribing patterns. Nevertheless, the authors noted the potentially negative implications of their findings.
“Because political affiliation should not be a factor in clinical treatment decisions, our findings raise concerns for public trust in a nonpartisan health care system,” the authors write.
Coauthor Ateev Mehrotra, MD, MPH, reported personal fees from Sanofi-Aventis, and coauthor Anupam B. Jena, MD, PhD, reported personal fees from Bioverativ, Merck, Janssen, Edwards Lifesciences, Novartis, Amgen, Eisai, Otsuka, Vertex, Celgene, Sanofi-Aventis, Precision Health Economics (now PRECISIONheor), Analysis Group, and Doubleday and hosting the podcast Freakonomics, M.D. The other coauthors have disclosed no relevant financial relationships. No external funding source was noted.
A version of this article first appeared on Medscape.com.
New prescriptions of hydroxychloroquine (HCQ) and ivermectin increased in 2020, driven particularly by rates in counties with the highest proportion of Republican votes in the 2020 U.S. presidential election, according to a cross-sectional study published in JAMA Internal Medicine.
“Our findings are consistent with the hypothesis that U.S. prescribing of hydroxychloroquine and ivermectin during the COVID-19 pandemic may have been influenced by political affiliation,” wrote Michael L. Barnett, MD, of the Harvard T.H. Chan School of Public Health in Boston and colleagues.
The researchers used data from the OptumLabs Data Warehouse to analyze commercial and Medicare Advantage medical claims from January 2019 through December 2020 for more than 18.5 million adults living in counties with at least 50 enrollees.
Using U.S. Census data and 2020 presidential election results, the researchers classified counties according to their proportion of Republican voters and then examined whether those proportions were associated with that county’s rates of new prescriptions for HCQ, ivermectin, methotrexate sodium, and albendazole. Methotrexate is prescribed for similar conditions and indications as HCQ, and albendazole is prescribed for similar reasons as ivermectin, although neither of the comparison drugs has been considered for COVID-19 treatment.
The Food and Drug Administration issued an emergency use authorization (EUA) for HCQ as a COVID-19 treatment on March 28, 2020, but the agency revoked the EUA 3 months later on June 15. Ivermectin never received an EUA for COVID treatment, but an in vitro study published April 3, 2020 claimed it had an antiviral effect.
The National Institutes of Health recommended against using ivermectin as a COVID-19 treatment on Aug. 1, 2020, but a few months later, on Nov. 13, a flawed clinical trial – later retracted – claimed ivermectin was 90% effective in treating COVID-19. Despite the lack of evidence for ivermectin’s efficacy, a Senate committee meeting on Dec. 8, 2020, included testimony from a physician who promoted its use.
In comparing ivermectin and HCQ prescription rates with counties’ political composition, the researchers adjusted their findings to account for differences in the counties’ racial composition and COVID-19 incidence as well as enrollees’ age, sex, insurance type, income, comorbidity burden, and home in a rural or urban area.
The results showed an average of 20 new HCQ prescriptions per 100,000 enrollees in 2019, but 2020 saw a sharp increase and drop in new HCQ prescriptions in March-April 2020, independent of counties’ breakdown of political affiliation.
“However, after June 2020, coinciding with the revocation of the U.S. Food and Drug Administration’s emergency use authorization for hydroxychloroquine, prescribing volume was significantly higher in the highest vs. lowest Republican vote share counties,” the authors report. The gradual increase from June through December 2020 averaged to 42 new prescriptions per 100,000, a 146% increase over 2019 rates that was driven largely by the 25% of counties with the highest proportion of Republican voters.
Similarly, rates of new ivermectin prescriptions in December 2020 were more than nine times higher in counties with the highest Republican vote share, compared with new prescriptions throughout 2019. The researchers found no differences in new prescriptions for methotrexate or albendazole in 2020 based on counties’ proportion of Republican votes.
Since the study is an ecological, observational one, it cannot show causation or shed light on what role patients, physicians, or other factors might have played in prescribing patterns. Nevertheless, the authors noted the potentially negative implications of their findings.
“Because political affiliation should not be a factor in clinical treatment decisions, our findings raise concerns for public trust in a nonpartisan health care system,” the authors write.
Coauthor Ateev Mehrotra, MD, MPH, reported personal fees from Sanofi-Aventis, and coauthor Anupam B. Jena, MD, PhD, reported personal fees from Bioverativ, Merck, Janssen, Edwards Lifesciences, Novartis, Amgen, Eisai, Otsuka, Vertex, Celgene, Sanofi-Aventis, Precision Health Economics (now PRECISIONheor), Analysis Group, and Doubleday and hosting the podcast Freakonomics, M.D. The other coauthors have disclosed no relevant financial relationships. No external funding source was noted.
A version of this article first appeared on Medscape.com.
New prescriptions of hydroxychloroquine (HCQ) and ivermectin increased in 2020, driven particularly by rates in counties with the highest proportion of Republican votes in the 2020 U.S. presidential election, according to a cross-sectional study published in JAMA Internal Medicine.
“Our findings are consistent with the hypothesis that U.S. prescribing of hydroxychloroquine and ivermectin during the COVID-19 pandemic may have been influenced by political affiliation,” wrote Michael L. Barnett, MD, of the Harvard T.H. Chan School of Public Health in Boston and colleagues.
The researchers used data from the OptumLabs Data Warehouse to analyze commercial and Medicare Advantage medical claims from January 2019 through December 2020 for more than 18.5 million adults living in counties with at least 50 enrollees.
Using U.S. Census data and 2020 presidential election results, the researchers classified counties according to their proportion of Republican voters and then examined whether those proportions were associated with that county’s rates of new prescriptions for HCQ, ivermectin, methotrexate sodium, and albendazole. Methotrexate is prescribed for similar conditions and indications as HCQ, and albendazole is prescribed for similar reasons as ivermectin, although neither of the comparison drugs has been considered for COVID-19 treatment.
The Food and Drug Administration issued an emergency use authorization (EUA) for HCQ as a COVID-19 treatment on March 28, 2020, but the agency revoked the EUA 3 months later on June 15. Ivermectin never received an EUA for COVID treatment, but an in vitro study published April 3, 2020 claimed it had an antiviral effect.
The National Institutes of Health recommended against using ivermectin as a COVID-19 treatment on Aug. 1, 2020, but a few months later, on Nov. 13, a flawed clinical trial – later retracted – claimed ivermectin was 90% effective in treating COVID-19. Despite the lack of evidence for ivermectin’s efficacy, a Senate committee meeting on Dec. 8, 2020, included testimony from a physician who promoted its use.
In comparing ivermectin and HCQ prescription rates with counties’ political composition, the researchers adjusted their findings to account for differences in the counties’ racial composition and COVID-19 incidence as well as enrollees’ age, sex, insurance type, income, comorbidity burden, and home in a rural or urban area.
The results showed an average of 20 new HCQ prescriptions per 100,000 enrollees in 2019, but 2020 saw a sharp increase and drop in new HCQ prescriptions in March-April 2020, independent of counties’ breakdown of political affiliation.
“However, after June 2020, coinciding with the revocation of the U.S. Food and Drug Administration’s emergency use authorization for hydroxychloroquine, prescribing volume was significantly higher in the highest vs. lowest Republican vote share counties,” the authors report. The gradual increase from June through December 2020 averaged to 42 new prescriptions per 100,000, a 146% increase over 2019 rates that was driven largely by the 25% of counties with the highest proportion of Republican voters.
Similarly, rates of new ivermectin prescriptions in December 2020 were more than nine times higher in counties with the highest Republican vote share, compared with new prescriptions throughout 2019. The researchers found no differences in new prescriptions for methotrexate or albendazole in 2020 based on counties’ proportion of Republican votes.
Since the study is an ecological, observational one, it cannot show causation or shed light on what role patients, physicians, or other factors might have played in prescribing patterns. Nevertheless, the authors noted the potentially negative implications of their findings.
“Because political affiliation should not be a factor in clinical treatment decisions, our findings raise concerns for public trust in a nonpartisan health care system,” the authors write.
Coauthor Ateev Mehrotra, MD, MPH, reported personal fees from Sanofi-Aventis, and coauthor Anupam B. Jena, MD, PhD, reported personal fees from Bioverativ, Merck, Janssen, Edwards Lifesciences, Novartis, Amgen, Eisai, Otsuka, Vertex, Celgene, Sanofi-Aventis, Precision Health Economics (now PRECISIONheor), Analysis Group, and Doubleday and hosting the podcast Freakonomics, M.D. The other coauthors have disclosed no relevant financial relationships. No external funding source was noted.
A version of this article first appeared on Medscape.com.
FROM JAMA INTERNAL MEDICINE
Long COVID is real and consists of these conditions – or does it?
Loss of smell. Fatigue. Mental health challenges. Difficulty breathing and other lower respiratory diseases. Fluid and electrolyte disorders. Cardiac dysrhythmia and other nonspecific chest pains. Trouble with urination. Diabetes?
Statistically, . The data, presented at the Conference on Retroviruses and Opportunistic Infections, can be used to guide diagnoses of long COVID, and may be the guide soon at Kaiser Permanente offices, Michael Horberg, MD, executive director of research, community benefit, and Medicaid strategy at the Mid-Atlantic Permanente Research Institute, said in an interview.
“There are some real conditions you could ask about” if you were evaluating a patient who believes they have PASC, Dr. Horberg said. “And there are real conditions that are symptoms patients have but they don’t fit the PASC diagnosis.”
That list is likely to evolve as specific symptoms emerge with new variants, he said. And there’s also the nationwide Researching COVID to Enhance Recovery (RECOVER) trial being conducted by the National Institutes of Health (NIH). Dr. Horberg is withholding judgment on diabetes, though, until more data come in.
During the global pandemic, Dr. Horberg, an HIV physician by training, found himself writing policies and guidelines for Kaiser’s Mid-Atlantic States (KPMAS) COVID response. Not long after that, the reports of symptoms that have come to be called long COVID started to come in. But they were “a mishmash of things” – everything from binge eating to the skin condition vitiligo to cranial nerve impairment, along with the more common complaints like fever, insomnia, and shortness of breath.
So Dr. Horberg looked back through KPMAS patient charts and found 28,118 members who had received a positive SARS-CoV-2 PCR test result in 2020. Then he matched them 3:1 with 70,293 members who didn’t have a positive PCR. The majority were women, nearly half were younger than 50, more than 40% were Black, and 24.5% were Latinx. The majority met clinical definitions of overweight or obese and many had other chronic illnesses, including diabetes (18.7% in the COVID-positive group), chronic kidney disease (3%) and cancer (2.6%). Rates of chronic illnesses were similar between arms.
Then they went back to 4 years before each positive PCR test and looked for all the illnesses before COVID, all those that emerged within 30 days of COVID diagnosis and those illnesses that emerged between 1 and 3 months after diagnosis.
From that search, they found 15 symptoms that were more common among people who’d had COVID. In addition to the symptoms listed above, those included abdominal pain, other nervous system disorders, dizziness or vertigo, and nausea and vomiting. Then they looked at whether each patient had experienced those symptoms in the 4 years before COVID to see if they were, in fact, new diagnoses.
More than 1 in 10
About one in four people who’d had COVID reported symptoms they thought might be long COVID, but through the analysis, they found that only 13% actually developed new conditions that could be categorized as long COVID.
“When you start controlling for all those chronic conditions, a lot of symptoms fall out,” Dr. Horberg told this news organization. “Plus, when you start comparing to the COVID-negative population, especially in the first 30 days of your positive diagnosis, actually, the COVID-negative patients have essentially almost the same amount, sometimes more.”
For instance, in the first month after diagnosis, though people with COVID reported anxiety symptoms after their diagnoses, people who’d never had COVID were coming in even more often with that symptom. And although gastrointestinal disorders were common in people who’d had COVID, they were just as likely in people who had not. Nausea and vomiting were actually 19% more common in people without COVID than in those with it. And people without COVID were nearly twice as likely to develop nutritional and endocrine disorders.
In the longer run, people who’d had COVID were 25% more likely to develop dysrhythmias, 20% more likely to develop diabetes, 60% more likely to develop fatigue, 21% more likely to develop genitourinary conditions, 39% more likely to develop chest pains, and a full 3.88 times more likely to develop trouble with olfaction.
And although people who’d had COVID were numerically 5% more likely to develop both abdominal pain and vertigo, 4% more likely to develop nervous system disorders, and 1% more likely to develop anxiety disorders longer term, none of those reached statistical significance.
The only diagnosis that doesn’t make sense to Dr. Horberg is diabetes.
“At this point I don’t think it’s been fully explained,” Dr. Horberg said. “I don’t think COVID is affecting the pancreas. But I do think that these are people who probably sought medical care, who hadn’t been seeking medical care and that the findings of diabetes were incidental diagnoses.”
Still, Dr. Horberg isn’t saying never on that. “As they say, more research is needed,” he added.
Ready to define long COVID?
As an intensive care unit physician and pulmonologist, Michael Risbano, MD, assistant professor of medicine at the University of Pittsburgh, has seen a lot of COVID. As the co-manager of the medical system’s post-COVID clinic, he’s also seen a lot of people coming in for help with what could be long COVID. When he saw the data from Dr. Horberg’s presentation, at first it seemed to confirm what he’d already known. But then he looked further.
“Well, this is actually making sense,” Dr. Risbano thought. At his clinic, it’s been an ongoing challenge to tease out what symptoms existed before COVID. Unlike Kaiser, the University of Pittsburgh Medical Center is not a closed system.
“We know some people who tend to get sick [with COVID] have some underlying medical issues already,” Dr. Risbano said in an interview. “But we don’t always have a good baseline as to what they were like beforehand, so we don’t always know what’s changed.”
He said the study design here, though retrospective and based on chart review rather than prospective observation, starts to put symptoms into the larger context of a patient’s life. And the diabetes association really stood out to him. He recalled one patient who, when she was admitted to the ICU, had a hemoglobin A1c that was totally normal. But when that patient returned a few months later, her blood sugar had skyrocketed.
“It was sky-high, like 13, and she was in diabetic ketoacidosis,” he said. “I know that’s an N of 1, but my wife is a dietitian and a case manager, and she’s having a lot of people coming in with a new diagnosis of diabetes.”
Still, he said he’s not sure that the conditions the study identified should be the basis for a definition of long COVID.
“I don’t know if you can come up with a definition out of this,” he said. “But I think this is at least helpful in telling us what disease states are different pre- and post-COVID, and what sorts of diagnoses clinicians should look for when a patient comes in after having a COVID diagnosis.”
Dr. Horberg and Dr. Risbano have disclosed no relevant financial relationships. The study was funded by the National Institute of Allergy and Infectious Diseases at the National Institutes of Health.
A version of this article first appeared on Medscape.com.
Loss of smell. Fatigue. Mental health challenges. Difficulty breathing and other lower respiratory diseases. Fluid and electrolyte disorders. Cardiac dysrhythmia and other nonspecific chest pains. Trouble with urination. Diabetes?
Statistically, . The data, presented at the Conference on Retroviruses and Opportunistic Infections, can be used to guide diagnoses of long COVID, and may be the guide soon at Kaiser Permanente offices, Michael Horberg, MD, executive director of research, community benefit, and Medicaid strategy at the Mid-Atlantic Permanente Research Institute, said in an interview.
“There are some real conditions you could ask about” if you were evaluating a patient who believes they have PASC, Dr. Horberg said. “And there are real conditions that are symptoms patients have but they don’t fit the PASC diagnosis.”
That list is likely to evolve as specific symptoms emerge with new variants, he said. And there’s also the nationwide Researching COVID to Enhance Recovery (RECOVER) trial being conducted by the National Institutes of Health (NIH). Dr. Horberg is withholding judgment on diabetes, though, until more data come in.
During the global pandemic, Dr. Horberg, an HIV physician by training, found himself writing policies and guidelines for Kaiser’s Mid-Atlantic States (KPMAS) COVID response. Not long after that, the reports of symptoms that have come to be called long COVID started to come in. But they were “a mishmash of things” – everything from binge eating to the skin condition vitiligo to cranial nerve impairment, along with the more common complaints like fever, insomnia, and shortness of breath.
So Dr. Horberg looked back through KPMAS patient charts and found 28,118 members who had received a positive SARS-CoV-2 PCR test result in 2020. Then he matched them 3:1 with 70,293 members who didn’t have a positive PCR. The majority were women, nearly half were younger than 50, more than 40% were Black, and 24.5% were Latinx. The majority met clinical definitions of overweight or obese and many had other chronic illnesses, including diabetes (18.7% in the COVID-positive group), chronic kidney disease (3%) and cancer (2.6%). Rates of chronic illnesses were similar between arms.
Then they went back to 4 years before each positive PCR test and looked for all the illnesses before COVID, all those that emerged within 30 days of COVID diagnosis and those illnesses that emerged between 1 and 3 months after diagnosis.
From that search, they found 15 symptoms that were more common among people who’d had COVID. In addition to the symptoms listed above, those included abdominal pain, other nervous system disorders, dizziness or vertigo, and nausea and vomiting. Then they looked at whether each patient had experienced those symptoms in the 4 years before COVID to see if they were, in fact, new diagnoses.
More than 1 in 10
About one in four people who’d had COVID reported symptoms they thought might be long COVID, but through the analysis, they found that only 13% actually developed new conditions that could be categorized as long COVID.
“When you start controlling for all those chronic conditions, a lot of symptoms fall out,” Dr. Horberg told this news organization. “Plus, when you start comparing to the COVID-negative population, especially in the first 30 days of your positive diagnosis, actually, the COVID-negative patients have essentially almost the same amount, sometimes more.”
For instance, in the first month after diagnosis, though people with COVID reported anxiety symptoms after their diagnoses, people who’d never had COVID were coming in even more often with that symptom. And although gastrointestinal disorders were common in people who’d had COVID, they were just as likely in people who had not. Nausea and vomiting were actually 19% more common in people without COVID than in those with it. And people without COVID were nearly twice as likely to develop nutritional and endocrine disorders.
In the longer run, people who’d had COVID were 25% more likely to develop dysrhythmias, 20% more likely to develop diabetes, 60% more likely to develop fatigue, 21% more likely to develop genitourinary conditions, 39% more likely to develop chest pains, and a full 3.88 times more likely to develop trouble with olfaction.
And although people who’d had COVID were numerically 5% more likely to develop both abdominal pain and vertigo, 4% more likely to develop nervous system disorders, and 1% more likely to develop anxiety disorders longer term, none of those reached statistical significance.
The only diagnosis that doesn’t make sense to Dr. Horberg is diabetes.
“At this point I don’t think it’s been fully explained,” Dr. Horberg said. “I don’t think COVID is affecting the pancreas. But I do think that these are people who probably sought medical care, who hadn’t been seeking medical care and that the findings of diabetes were incidental diagnoses.”
Still, Dr. Horberg isn’t saying never on that. “As they say, more research is needed,” he added.
Ready to define long COVID?
As an intensive care unit physician and pulmonologist, Michael Risbano, MD, assistant professor of medicine at the University of Pittsburgh, has seen a lot of COVID. As the co-manager of the medical system’s post-COVID clinic, he’s also seen a lot of people coming in for help with what could be long COVID. When he saw the data from Dr. Horberg’s presentation, at first it seemed to confirm what he’d already known. But then he looked further.
“Well, this is actually making sense,” Dr. Risbano thought. At his clinic, it’s been an ongoing challenge to tease out what symptoms existed before COVID. Unlike Kaiser, the University of Pittsburgh Medical Center is not a closed system.
“We know some people who tend to get sick [with COVID] have some underlying medical issues already,” Dr. Risbano said in an interview. “But we don’t always have a good baseline as to what they were like beforehand, so we don’t always know what’s changed.”
He said the study design here, though retrospective and based on chart review rather than prospective observation, starts to put symptoms into the larger context of a patient’s life. And the diabetes association really stood out to him. He recalled one patient who, when she was admitted to the ICU, had a hemoglobin A1c that was totally normal. But when that patient returned a few months later, her blood sugar had skyrocketed.
“It was sky-high, like 13, and she was in diabetic ketoacidosis,” he said. “I know that’s an N of 1, but my wife is a dietitian and a case manager, and she’s having a lot of people coming in with a new diagnosis of diabetes.”
Still, he said he’s not sure that the conditions the study identified should be the basis for a definition of long COVID.
“I don’t know if you can come up with a definition out of this,” he said. “But I think this is at least helpful in telling us what disease states are different pre- and post-COVID, and what sorts of diagnoses clinicians should look for when a patient comes in after having a COVID diagnosis.”
Dr. Horberg and Dr. Risbano have disclosed no relevant financial relationships. The study was funded by the National Institute of Allergy and Infectious Diseases at the National Institutes of Health.
A version of this article first appeared on Medscape.com.
Loss of smell. Fatigue. Mental health challenges. Difficulty breathing and other lower respiratory diseases. Fluid and electrolyte disorders. Cardiac dysrhythmia and other nonspecific chest pains. Trouble with urination. Diabetes?
Statistically, . The data, presented at the Conference on Retroviruses and Opportunistic Infections, can be used to guide diagnoses of long COVID, and may be the guide soon at Kaiser Permanente offices, Michael Horberg, MD, executive director of research, community benefit, and Medicaid strategy at the Mid-Atlantic Permanente Research Institute, said in an interview.
“There are some real conditions you could ask about” if you were evaluating a patient who believes they have PASC, Dr. Horberg said. “And there are real conditions that are symptoms patients have but they don’t fit the PASC diagnosis.”
That list is likely to evolve as specific symptoms emerge with new variants, he said. And there’s also the nationwide Researching COVID to Enhance Recovery (RECOVER) trial being conducted by the National Institutes of Health (NIH). Dr. Horberg is withholding judgment on diabetes, though, until more data come in.
During the global pandemic, Dr. Horberg, an HIV physician by training, found himself writing policies and guidelines for Kaiser’s Mid-Atlantic States (KPMAS) COVID response. Not long after that, the reports of symptoms that have come to be called long COVID started to come in. But they were “a mishmash of things” – everything from binge eating to the skin condition vitiligo to cranial nerve impairment, along with the more common complaints like fever, insomnia, and shortness of breath.
So Dr. Horberg looked back through KPMAS patient charts and found 28,118 members who had received a positive SARS-CoV-2 PCR test result in 2020. Then he matched them 3:1 with 70,293 members who didn’t have a positive PCR. The majority were women, nearly half were younger than 50, more than 40% were Black, and 24.5% were Latinx. The majority met clinical definitions of overweight or obese and many had other chronic illnesses, including diabetes (18.7% in the COVID-positive group), chronic kidney disease (3%) and cancer (2.6%). Rates of chronic illnesses were similar between arms.
Then they went back to 4 years before each positive PCR test and looked for all the illnesses before COVID, all those that emerged within 30 days of COVID diagnosis and those illnesses that emerged between 1 and 3 months after diagnosis.
From that search, they found 15 symptoms that were more common among people who’d had COVID. In addition to the symptoms listed above, those included abdominal pain, other nervous system disorders, dizziness or vertigo, and nausea and vomiting. Then they looked at whether each patient had experienced those symptoms in the 4 years before COVID to see if they were, in fact, new diagnoses.
More than 1 in 10
About one in four people who’d had COVID reported symptoms they thought might be long COVID, but through the analysis, they found that only 13% actually developed new conditions that could be categorized as long COVID.
“When you start controlling for all those chronic conditions, a lot of symptoms fall out,” Dr. Horberg told this news organization. “Plus, when you start comparing to the COVID-negative population, especially in the first 30 days of your positive diagnosis, actually, the COVID-negative patients have essentially almost the same amount, sometimes more.”
For instance, in the first month after diagnosis, though people with COVID reported anxiety symptoms after their diagnoses, people who’d never had COVID were coming in even more often with that symptom. And although gastrointestinal disorders were common in people who’d had COVID, they were just as likely in people who had not. Nausea and vomiting were actually 19% more common in people without COVID than in those with it. And people without COVID were nearly twice as likely to develop nutritional and endocrine disorders.
In the longer run, people who’d had COVID were 25% more likely to develop dysrhythmias, 20% more likely to develop diabetes, 60% more likely to develop fatigue, 21% more likely to develop genitourinary conditions, 39% more likely to develop chest pains, and a full 3.88 times more likely to develop trouble with olfaction.
And although people who’d had COVID were numerically 5% more likely to develop both abdominal pain and vertigo, 4% more likely to develop nervous system disorders, and 1% more likely to develop anxiety disorders longer term, none of those reached statistical significance.
The only diagnosis that doesn’t make sense to Dr. Horberg is diabetes.
“At this point I don’t think it’s been fully explained,” Dr. Horberg said. “I don’t think COVID is affecting the pancreas. But I do think that these are people who probably sought medical care, who hadn’t been seeking medical care and that the findings of diabetes were incidental diagnoses.”
Still, Dr. Horberg isn’t saying never on that. “As they say, more research is needed,” he added.
Ready to define long COVID?
As an intensive care unit physician and pulmonologist, Michael Risbano, MD, assistant professor of medicine at the University of Pittsburgh, has seen a lot of COVID. As the co-manager of the medical system’s post-COVID clinic, he’s also seen a lot of people coming in for help with what could be long COVID. When he saw the data from Dr. Horberg’s presentation, at first it seemed to confirm what he’d already known. But then he looked further.
“Well, this is actually making sense,” Dr. Risbano thought. At his clinic, it’s been an ongoing challenge to tease out what symptoms existed before COVID. Unlike Kaiser, the University of Pittsburgh Medical Center is not a closed system.
“We know some people who tend to get sick [with COVID] have some underlying medical issues already,” Dr. Risbano said in an interview. “But we don’t always have a good baseline as to what they were like beforehand, so we don’t always know what’s changed.”
He said the study design here, though retrospective and based on chart review rather than prospective observation, starts to put symptoms into the larger context of a patient’s life. And the diabetes association really stood out to him. He recalled one patient who, when she was admitted to the ICU, had a hemoglobin A1c that was totally normal. But when that patient returned a few months later, her blood sugar had skyrocketed.
“It was sky-high, like 13, and she was in diabetic ketoacidosis,” he said. “I know that’s an N of 1, but my wife is a dietitian and a case manager, and she’s having a lot of people coming in with a new diagnosis of diabetes.”
Still, he said he’s not sure that the conditions the study identified should be the basis for a definition of long COVID.
“I don’t know if you can come up with a definition out of this,” he said. “But I think this is at least helpful in telling us what disease states are different pre- and post-COVID, and what sorts of diagnoses clinicians should look for when a patient comes in after having a COVID diagnosis.”
Dr. Horberg and Dr. Risbano have disclosed no relevant financial relationships. The study was funded by the National Institute of Allergy and Infectious Diseases at the National Institutes of Health.
A version of this article first appeared on Medscape.com.
FROM CROI 2022
Post–COVID vaccine AHA cases raise eyebrows in Italy
“The overall number of cases observed does not allow ... any definitive conclusion over a possible causal relationship between SARS-CoV-2 vaccination and AHA, which would need more epidemiological and pharmacovigilance data about suspected vaccine-related adverse events,” Maria Cristina Leone, MD, of Azienda USL-IRCCS di Reggio Emilia (Italy), and colleagues reported online on Jan. 19, 2022, in a letter to the editors of Thrombosis Research.
The cases, observed in Reggio Emilia during the first 8 months of the vaccination campaign, occurred following receipt of mRNA BNT162b2 (Pfizer-BioNTech) vaccine. The AHA patients included two men and two women who ranged in age from 67 to 86 years.
During this time frame, 235,597 people received at least one dose of BNT162b2 vaccine, the authors noted.
In the 5 years prior, from January 2016 to December 2020, only zero to two cases of AHA were observed each year, totaling five cases, or 1.9 cases per million people/year. These numbers are in line with the estimated incidence of the disease, the researchers noted, adding that “it should nonetheless be underlined that vaccination benefits exceed potential side effects and play a central role in individual and public health to effectively protect people from COVID-19 and stop the pandemic.”
However, they also wrote that the “unusual observation of four cases of a rare disease during the first months of the vaccination campaign in our province could be of interest and could sensitize health care personnel toward a possible complication of SARS-CoV-2 immunization.”
AHA is a rare autoimmune disease caused by neutralizing autoantibodies against coagulation factor VIII. It is mainly associated with malignancy, autoimmune diseases, certain medications, and postnatal status.
“Sporadic AHA cases have been reported in association with infectious diseases or vaccinations,” the author noted, adding that associations between the BNT162b2 vaccine immune complications, including AHA, have also been reported by other authors.
Three of the four case patients in Reggio Emilia had “at least one common clinical association of AHA,” they found, suggesting that these associations could “reflect susceptibility to autoimmunity potentially triggered by vaccination.”
“Case four died due to complications from sepsis after being treated with steroid and rituximab, whereas the first three cases underwent clinical and laboratory remission after immunosuppressive therapy, and no relapse has been observed during follow-up, as in the other two cases reported: This could suggest a more favorable prognosis in respect to other non–vaccine-associated cases, but longer-term data are definitely needed,” they concluded.
The authors reported having no disclosures.
“The overall number of cases observed does not allow ... any definitive conclusion over a possible causal relationship between SARS-CoV-2 vaccination and AHA, which would need more epidemiological and pharmacovigilance data about suspected vaccine-related adverse events,” Maria Cristina Leone, MD, of Azienda USL-IRCCS di Reggio Emilia (Italy), and colleagues reported online on Jan. 19, 2022, in a letter to the editors of Thrombosis Research.
The cases, observed in Reggio Emilia during the first 8 months of the vaccination campaign, occurred following receipt of mRNA BNT162b2 (Pfizer-BioNTech) vaccine. The AHA patients included two men and two women who ranged in age from 67 to 86 years.
During this time frame, 235,597 people received at least one dose of BNT162b2 vaccine, the authors noted.
In the 5 years prior, from January 2016 to December 2020, only zero to two cases of AHA were observed each year, totaling five cases, or 1.9 cases per million people/year. These numbers are in line with the estimated incidence of the disease, the researchers noted, adding that “it should nonetheless be underlined that vaccination benefits exceed potential side effects and play a central role in individual and public health to effectively protect people from COVID-19 and stop the pandemic.”
However, they also wrote that the “unusual observation of four cases of a rare disease during the first months of the vaccination campaign in our province could be of interest and could sensitize health care personnel toward a possible complication of SARS-CoV-2 immunization.”
AHA is a rare autoimmune disease caused by neutralizing autoantibodies against coagulation factor VIII. It is mainly associated with malignancy, autoimmune diseases, certain medications, and postnatal status.
“Sporadic AHA cases have been reported in association with infectious diseases or vaccinations,” the author noted, adding that associations between the BNT162b2 vaccine immune complications, including AHA, have also been reported by other authors.
Three of the four case patients in Reggio Emilia had “at least one common clinical association of AHA,” they found, suggesting that these associations could “reflect susceptibility to autoimmunity potentially triggered by vaccination.”
“Case four died due to complications from sepsis after being treated with steroid and rituximab, whereas the first three cases underwent clinical and laboratory remission after immunosuppressive therapy, and no relapse has been observed during follow-up, as in the other two cases reported: This could suggest a more favorable prognosis in respect to other non–vaccine-associated cases, but longer-term data are definitely needed,” they concluded.
The authors reported having no disclosures.
“The overall number of cases observed does not allow ... any definitive conclusion over a possible causal relationship between SARS-CoV-2 vaccination and AHA, which would need more epidemiological and pharmacovigilance data about suspected vaccine-related adverse events,” Maria Cristina Leone, MD, of Azienda USL-IRCCS di Reggio Emilia (Italy), and colleagues reported online on Jan. 19, 2022, in a letter to the editors of Thrombosis Research.
The cases, observed in Reggio Emilia during the first 8 months of the vaccination campaign, occurred following receipt of mRNA BNT162b2 (Pfizer-BioNTech) vaccine. The AHA patients included two men and two women who ranged in age from 67 to 86 years.
During this time frame, 235,597 people received at least one dose of BNT162b2 vaccine, the authors noted.
In the 5 years prior, from January 2016 to December 2020, only zero to two cases of AHA were observed each year, totaling five cases, or 1.9 cases per million people/year. These numbers are in line with the estimated incidence of the disease, the researchers noted, adding that “it should nonetheless be underlined that vaccination benefits exceed potential side effects and play a central role in individual and public health to effectively protect people from COVID-19 and stop the pandemic.”
However, they also wrote that the “unusual observation of four cases of a rare disease during the first months of the vaccination campaign in our province could be of interest and could sensitize health care personnel toward a possible complication of SARS-CoV-2 immunization.”
AHA is a rare autoimmune disease caused by neutralizing autoantibodies against coagulation factor VIII. It is mainly associated with malignancy, autoimmune diseases, certain medications, and postnatal status.
“Sporadic AHA cases have been reported in association with infectious diseases or vaccinations,” the author noted, adding that associations between the BNT162b2 vaccine immune complications, including AHA, have also been reported by other authors.
Three of the four case patients in Reggio Emilia had “at least one common clinical association of AHA,” they found, suggesting that these associations could “reflect susceptibility to autoimmunity potentially triggered by vaccination.”
“Case four died due to complications from sepsis after being treated with steroid and rituximab, whereas the first three cases underwent clinical and laboratory remission after immunosuppressive therapy, and no relapse has been observed during follow-up, as in the other two cases reported: This could suggest a more favorable prognosis in respect to other non–vaccine-associated cases, but longer-term data are definitely needed,” they concluded.
The authors reported having no disclosures.
FROM THROMBOSIS RESEARCH
ACIP issues adult vaccination schedule 2022
by the Advisory Committee on Immunization Practices (ACIP) of the Centers for Disease Control and Prevention (CDC).
The Clinical Guideline on the “Recommended Adult Immunization Schedule, United States, 2022” appears online Feb. 17 in Annals of Internal Medicine and in the CDC’s Morbidity and Mortality Weekly Report.
The document features changes to the zoster, pneumococcal, and hepatitis B vaccines. COVID-19 vaccinations are now included in the notes section of the schedule and can be co-administered with other vaccines, according to ACIP.
The 2022 schedule is particularly important because the pandemic has caused many adults to fall behind in routine vaccinations, according to lead author Neil Murthy, MD, MPH, MSJ, of the CDC’s immunization services division, National Center for Immunization and Respiratory Diseases, and colleagues.
“Providers should administer all due and overdue vaccines according to the routine immunization schedule during the same visit,” the group wrote. “In addition, providers should implement strategies to catch up all patients on any overdue vaccines.”
Among other changes appearing in the 2022 recommendations:
- A new step 4 in the form of an appendix lists all the contraindications and precautions for each vaccine.
- The zoster vaccine now is recommended for use in everyone aged 19 years and older who are or will be immunodeficient or immunosuppressed through disease or therapy. The new purple color bar reflects ACIP’s new two-dose series regimen for immunocompromised adults aged 19 to 49.
- The simplified pneumococcal recommendation includes guidance on using the new PCV15 and PCV20 vaccines.
- The hepatitis B recommendation has been made more inclusive, with vaccination recommended for all adults aged 19 to 59. The Special Situations section in the Notes outlines the risk-based recommendations for the hepatitis B vaccine in adults aged 60 and older. The schedule has been harmonized with the 2022 Child and Adolescent Immunization Schedule.
A welcome change
Sandra A. Fryhofer, MD, a member of the ACIP Combined Immunization Work Group, said the new pneumococcal recommendation is a particularly welcome change.
“The old recommendation was complicated and confusing. The new one is much more straightforward,” Dr. Fryhofer, an internist in Atlanta, said in an interview. Now there are only two options: a two-vaccine series of PCV15 (Vaxneuvance), in combination with the already familiar PPSV23 polysaccharide vaccine (Pneumovax 23), and a single dose of the new PCV20, Prevnar 20.
“Some work group members favored a universal age-based recommendation starting at 50 instead of 65,” Fryhofer said. “This would provide more opportunities to vaccinate adults but could lead to waning immunity later in life when risk of disease is higher.”
Although none of the updates is likely to stir controversy, discussion among ACIP members was particularly lively around hepatitis B vaccination, Dr. Fryhofer said. This vaccine has historically been recommended based on risk and has had poor uptake, while age-based vaccine recommendations generally have greater uptake.
“ACIP approved hepatitis B vaccine universally for those up to age 60, but for those 60 and older, the recommendation remains risk-based with a loophole: Anyone 60 and older who wants it can get it,” she told this news organization. “Some of the risk indications for hepatitis B vaccination may be uncomfortable or embarrassing to disclose, especially for older patients. The loophole takes care of that, but patients may have to ask for the vaccine.”
As usual, the graphics have been fine-tuned for greater accuracy and readability. “You can print a color copy to have in the exam room or at your workspace or give it a bookmark and check it online,” Dr. Fryhofer said. “It’s a great resource to have at your fingertips.”
Dr. Fryhofer has made a series of videos explaining ACIP’s approval process, the use of the schedule, and changes to vaccines including influenza. These can be accessed on the American College of Physicians website.
The authors of the recommendations stress that physicians should pay careful attention to the notes section for each vaccine, as these details clarify who needs what vaccine, when, and at what dose.
Co-author Henry Bernstein, DO, reported that he is the editor of Current Opinion in Pediatrics Office Pediatrics Series and received a presentation honorarium from the Florida chapter of the American Academy of Pediatrics. Co-author Kevin Ault, MD, reported having received a grant from the National Cancer Institute, consulting fees from PathoVax, and payments supporting attending meetings and/or travel from the American College of Obstetricians and Gynecologists.
A version of this article first appeared on Medscape.com.
by the Advisory Committee on Immunization Practices (ACIP) of the Centers for Disease Control and Prevention (CDC).
The Clinical Guideline on the “Recommended Adult Immunization Schedule, United States, 2022” appears online Feb. 17 in Annals of Internal Medicine and in the CDC’s Morbidity and Mortality Weekly Report.
The document features changes to the zoster, pneumococcal, and hepatitis B vaccines. COVID-19 vaccinations are now included in the notes section of the schedule and can be co-administered with other vaccines, according to ACIP.
The 2022 schedule is particularly important because the pandemic has caused many adults to fall behind in routine vaccinations, according to lead author Neil Murthy, MD, MPH, MSJ, of the CDC’s immunization services division, National Center for Immunization and Respiratory Diseases, and colleagues.
“Providers should administer all due and overdue vaccines according to the routine immunization schedule during the same visit,” the group wrote. “In addition, providers should implement strategies to catch up all patients on any overdue vaccines.”
Among other changes appearing in the 2022 recommendations:
- A new step 4 in the form of an appendix lists all the contraindications and precautions for each vaccine.
- The zoster vaccine now is recommended for use in everyone aged 19 years and older who are or will be immunodeficient or immunosuppressed through disease or therapy. The new purple color bar reflects ACIP’s new two-dose series regimen for immunocompromised adults aged 19 to 49.
- The simplified pneumococcal recommendation includes guidance on using the new PCV15 and PCV20 vaccines.
- The hepatitis B recommendation has been made more inclusive, with vaccination recommended for all adults aged 19 to 59. The Special Situations section in the Notes outlines the risk-based recommendations for the hepatitis B vaccine in adults aged 60 and older. The schedule has been harmonized with the 2022 Child and Adolescent Immunization Schedule.
A welcome change
Sandra A. Fryhofer, MD, a member of the ACIP Combined Immunization Work Group, said the new pneumococcal recommendation is a particularly welcome change.
“The old recommendation was complicated and confusing. The new one is much more straightforward,” Dr. Fryhofer, an internist in Atlanta, said in an interview. Now there are only two options: a two-vaccine series of PCV15 (Vaxneuvance), in combination with the already familiar PPSV23 polysaccharide vaccine (Pneumovax 23), and a single dose of the new PCV20, Prevnar 20.
“Some work group members favored a universal age-based recommendation starting at 50 instead of 65,” Fryhofer said. “This would provide more opportunities to vaccinate adults but could lead to waning immunity later in life when risk of disease is higher.”
Although none of the updates is likely to stir controversy, discussion among ACIP members was particularly lively around hepatitis B vaccination, Dr. Fryhofer said. This vaccine has historically been recommended based on risk and has had poor uptake, while age-based vaccine recommendations generally have greater uptake.
“ACIP approved hepatitis B vaccine universally for those up to age 60, but for those 60 and older, the recommendation remains risk-based with a loophole: Anyone 60 and older who wants it can get it,” she told this news organization. “Some of the risk indications for hepatitis B vaccination may be uncomfortable or embarrassing to disclose, especially for older patients. The loophole takes care of that, but patients may have to ask for the vaccine.”
As usual, the graphics have been fine-tuned for greater accuracy and readability. “You can print a color copy to have in the exam room or at your workspace or give it a bookmark and check it online,” Dr. Fryhofer said. “It’s a great resource to have at your fingertips.”
Dr. Fryhofer has made a series of videos explaining ACIP’s approval process, the use of the schedule, and changes to vaccines including influenza. These can be accessed on the American College of Physicians website.
The authors of the recommendations stress that physicians should pay careful attention to the notes section for each vaccine, as these details clarify who needs what vaccine, when, and at what dose.
Co-author Henry Bernstein, DO, reported that he is the editor of Current Opinion in Pediatrics Office Pediatrics Series and received a presentation honorarium from the Florida chapter of the American Academy of Pediatrics. Co-author Kevin Ault, MD, reported having received a grant from the National Cancer Institute, consulting fees from PathoVax, and payments supporting attending meetings and/or travel from the American College of Obstetricians and Gynecologists.
A version of this article first appeared on Medscape.com.
by the Advisory Committee on Immunization Practices (ACIP) of the Centers for Disease Control and Prevention (CDC).
The Clinical Guideline on the “Recommended Adult Immunization Schedule, United States, 2022” appears online Feb. 17 in Annals of Internal Medicine and in the CDC’s Morbidity and Mortality Weekly Report.
The document features changes to the zoster, pneumococcal, and hepatitis B vaccines. COVID-19 vaccinations are now included in the notes section of the schedule and can be co-administered with other vaccines, according to ACIP.
The 2022 schedule is particularly important because the pandemic has caused many adults to fall behind in routine vaccinations, according to lead author Neil Murthy, MD, MPH, MSJ, of the CDC’s immunization services division, National Center for Immunization and Respiratory Diseases, and colleagues.
“Providers should administer all due and overdue vaccines according to the routine immunization schedule during the same visit,” the group wrote. “In addition, providers should implement strategies to catch up all patients on any overdue vaccines.”
Among other changes appearing in the 2022 recommendations:
- A new step 4 in the form of an appendix lists all the contraindications and precautions for each vaccine.
- The zoster vaccine now is recommended for use in everyone aged 19 years and older who are or will be immunodeficient or immunosuppressed through disease or therapy. The new purple color bar reflects ACIP’s new two-dose series regimen for immunocompromised adults aged 19 to 49.
- The simplified pneumococcal recommendation includes guidance on using the new PCV15 and PCV20 vaccines.
- The hepatitis B recommendation has been made more inclusive, with vaccination recommended for all adults aged 19 to 59. The Special Situations section in the Notes outlines the risk-based recommendations for the hepatitis B vaccine in adults aged 60 and older. The schedule has been harmonized with the 2022 Child and Adolescent Immunization Schedule.
A welcome change
Sandra A. Fryhofer, MD, a member of the ACIP Combined Immunization Work Group, said the new pneumococcal recommendation is a particularly welcome change.
“The old recommendation was complicated and confusing. The new one is much more straightforward,” Dr. Fryhofer, an internist in Atlanta, said in an interview. Now there are only two options: a two-vaccine series of PCV15 (Vaxneuvance), in combination with the already familiar PPSV23 polysaccharide vaccine (Pneumovax 23), and a single dose of the new PCV20, Prevnar 20.
“Some work group members favored a universal age-based recommendation starting at 50 instead of 65,” Fryhofer said. “This would provide more opportunities to vaccinate adults but could lead to waning immunity later in life when risk of disease is higher.”
Although none of the updates is likely to stir controversy, discussion among ACIP members was particularly lively around hepatitis B vaccination, Dr. Fryhofer said. This vaccine has historically been recommended based on risk and has had poor uptake, while age-based vaccine recommendations generally have greater uptake.
“ACIP approved hepatitis B vaccine universally for those up to age 60, but for those 60 and older, the recommendation remains risk-based with a loophole: Anyone 60 and older who wants it can get it,” she told this news organization. “Some of the risk indications for hepatitis B vaccination may be uncomfortable or embarrassing to disclose, especially for older patients. The loophole takes care of that, but patients may have to ask for the vaccine.”
As usual, the graphics have been fine-tuned for greater accuracy and readability. “You can print a color copy to have in the exam room or at your workspace or give it a bookmark and check it online,” Dr. Fryhofer said. “It’s a great resource to have at your fingertips.”
Dr. Fryhofer has made a series of videos explaining ACIP’s approval process, the use of the schedule, and changes to vaccines including influenza. These can be accessed on the American College of Physicians website.
The authors of the recommendations stress that physicians should pay careful attention to the notes section for each vaccine, as these details clarify who needs what vaccine, when, and at what dose.
Co-author Henry Bernstein, DO, reported that he is the editor of Current Opinion in Pediatrics Office Pediatrics Series and received a presentation honorarium from the Florida chapter of the American Academy of Pediatrics. Co-author Kevin Ault, MD, reported having received a grant from the National Cancer Institute, consulting fees from PathoVax, and payments supporting attending meetings and/or travel from the American College of Obstetricians and Gynecologists.
A version of this article first appeared on Medscape.com.
Patients are interrupting DMARD use well into the COVID-19 pandemic
The COVID-19 pandemic led to a decrease in the proportion of patients with rheumatic diseases who stopped taking their disease-modifying antirheumatic drugs (DMARDs), but the percentage who interrupted DMARD treatment increased later in the pandemic, according to speakers at the 2022 Rheumatology Winter Clinical Symposium.
“People seem to be less anxious, but they’re interrupting their DMARD therapy more, more recently than in the pits of COVID, if you will,” said Arthur Kavanaugh, MD, professor of medicine at the University of California, San Diego, and director of RWCS.
Dr. Kavanaugh and his copresenter Jack Cush, MD, were discussing the results of a recent study published in Arthritis Care & Research that evaluated 2,424 patients with rheumatic diseases who completed a baseline and at least one follow-up survey issued by patient organizations between March 2020 and May 2021, with a median of five follow-up surveys completed. The patients included in the study were aged a mean of 57 years, 86.6% were women, 90.5% were White, 41.8% had rheumatoid arthritis (RA), 14.8% had antineutrophil cytoplasmic antibody (ANCA)-associated vasculitis, and 12.4% had psoriatic arthritis. Overall, 52.6% were on biologics or a Janus kinase (JAK) inhibitor, 30.0% were receiving methotrexate, 21.4% were taking hydroxychloroquine, and 28.6% were receiving low-dose (24.0%) or high-dose (4.6%) glucocorticoids.
Patients’ T-scores on the anxiety short form Patient-Reported Outcomes Measurement Information System (PROMIS) survey significantly decreased from a score of 58.7 in April 2020 to a score of 53.7 in May 2021 (P < .001), but there was a significant decrease in the interruption of DMARD treatment between April and December 2020 (11.2% vs. 7.5%; P < .001). This percentage rose significantly to 14.0% by May 2021 (P < .001). Patients who stopped using DMARDs were significantly associated with predicted incidence of severe flare in the next survey in adjusted models (12.9% vs. 8.0%; odds ratio, 1.71; 95% confidence interval, 1.23-2.36).
The results tell us “that we as a discipline are not doing a good job educating our patients,” said Dr. Cush, a rheumatologist based in Dallas, Tex., and executive editor of RheumNow.com.
“I wish we – and I’m really talking about myself – but myself and my practice were more proactive when COVID happened [in] sending out regular bulletins: ‘Don’t stop your therapy; these are the things you get; get the test that you need to get done,’ ” he said. “We let a lot of things go on autopilot with the patient driving throughout COVID. Even now, it’s happening. And this is a problem, and there are going to be consequences to this.”
Dr. Kavanaugh agreed with Dr. Cush’s assessment, suggesting that the pandemic came up quickly enough that it was difficult to be proactive with the situation.
Patients on JAK inhibitors as new COVID-19 risk group?
Another standout study on COVID-19 from 2021 was an analysis of the COVID-19 Global Rheumatology Alliance physician registry that examined risk of COVID-19 severity for patients with RA taking biologic or targeted synthetic DMARDs (tsDMARDs), which was presented at the 2021 EULAR congress and later published in Annals of the Rheumatic Diseases.
The researchers evaluated 2,869 patients March 2020 and April 2021 who were receiving abatacept (237 patients), rituximab (364 patients), interleukin (IL)-6 inhibitors (317 patients), JAK inhibitors (563 patients), or tumor necrosis factor (TNF) inhibitors such as infliximab, etanercept, adalimumab, certolizumab pegol, and golimumab (1,388 patients) before developing COVID-19. Data about biologics or tsDMARDs were collected as a drug class. Patients in the study were mostly White (69.0%) women (80.8%) with a mean age of 56.7 years who lived in Europe (51.8%) or North America (35.0%). The researchers examined the severity of COVID-19 among all patients studied and calculated odds ratios based on drug class, with the TNF inhibitor group serving as a reference.
“[I]n this case, they said that the baseline use of rituximab was associated with more severity, and you see the severity being hospitalization and ICU and deaths. They found a signal for the JAK inhibitors that is not found in the other studies,” Dr. Kavanaugh said.
Overall, they found 21% of patients in the registry were hospitalized and 5.5% died, with rituximab (OR, 4.15; 95% CI, 3.16-5.44) and JAK inhibitors (OR, 2.06; 95% CI, 1.60-2.65) associated with more severe COVID-19 outcomes. Specifically, rituximab was associated with greater likelihood of hospitalization (OR, 4.53; 95% CI, 3.32-6.18), hospitalization with oxygen/ventilation (OR, 2.87; 95% CI, 2.03-4.06), need for mechanical ventilation (OR, 4.05; 95% CI, 3.08-5.33), and mortality (OR, 4.57; 95% CI, 3.32-9.01), compared with TNF inhibitors. For JAK inhibitors, there was also a greater likelihood of hospitalization (OR, 2.40; 95% CI, 1.78-3.24), hospitalization with oxygen/ventilation (OR, 1.55; 95% CI, 1.04-2.18), need for mechanical ventilation (OR, 2.03; 95% CI, 1.56-2.62), and mortality (OR, 2.04; 95% CI, 1.58-2.65), compared with the TNF inhibitors group. Associations between COVID-19 severity and abatacept or IL-6 inhibitors were not identified.
Commenting on the study in a question-and-answer session, Roy Fleischmann, MD, said the part of the study that identified a signal for JAK inhibitors was “very interesting.” He called attention to a rapid response comment to the study, which questioned if it was the drug class itself that caused the risk for severe disease. “This is very important, because actually, the patients who stop the JAK [inhibitor], that’s what drove the illness. The patients [who] continued the JAK [inhibitor], very few of them had illness,” said Dr. Fleischmann, clinical professor of medicine at the University of Texas Southwestern Medical School and codirector of the Metroplex Clinical Research Center, both in Dallas, Tex.
Confusion among patients during COVID-19
Alvin Wells, MD, PhD, asked the copresenters during the Q&A session whether they had any clinical pearls for the audience on how they manage treatment of patients with rheumatic disease with potential COVID-19 risk. “I think the confusion with our patients and COVID is what the ACR has put out with their guidelines,” said Dr. Wells, director of the department of rheumatology at Advocate Aurora Health in Franklin, Wisc.
Dr. Cush said he has three rules he follows: lower and discontinue steroids, avoid rituximab as a starting treatment and negotiate if patients are already taking it, and don’t stop any therapy.
“I want disease control. I think being under control is what keeps you away from risk of COVID and hospitalization,” Dr. Cush said. “I think being uncontrolled and inflamed, whether it’s our [patients with] inflammatory arthritis or lupus or, worse, vasculitis [or] myositis, those are the ones at high risk of progression from being just infected to being sick and in the hospital.”
Eric Ruderman, MD, professor of rheumatology at Northwestern University, Chicago, posed the question of getting somewhat back to normal during COVID-19 with regard to recently infected patients presenting at infusion centers, whether patients are more likely to continue testing positive, and when patients are cleared to come back. Dr. Ruderman said his center has a 20-day rule for returning after having COVID-19, while Dr. Cush said his center allows patients to come in if they test negative after 7-10 days.
“One of the things we’re struggling with is our infusion center, and one of the questions that keeps coming up is when can people come back after a COVID infection?” he said. “If you’re on a drug at home, that’s up to you and the patient. But in the infusion [center], then you have other people sitting around there.”
Dr. Kavanaugh said there is no current data for how long patients with rheumatic disease shed virus, or how long a positive test can be measured. “You definitely will continue to shed, and you’ll be detectable for a while,” he said.
Dr. Cush and Dr. Kavanaugh reported having financial relationships with numerous pharmaceutical companies.
The COVID-19 pandemic led to a decrease in the proportion of patients with rheumatic diseases who stopped taking their disease-modifying antirheumatic drugs (DMARDs), but the percentage who interrupted DMARD treatment increased later in the pandemic, according to speakers at the 2022 Rheumatology Winter Clinical Symposium.
“People seem to be less anxious, but they’re interrupting their DMARD therapy more, more recently than in the pits of COVID, if you will,” said Arthur Kavanaugh, MD, professor of medicine at the University of California, San Diego, and director of RWCS.
Dr. Kavanaugh and his copresenter Jack Cush, MD, were discussing the results of a recent study published in Arthritis Care & Research that evaluated 2,424 patients with rheumatic diseases who completed a baseline and at least one follow-up survey issued by patient organizations between March 2020 and May 2021, with a median of five follow-up surveys completed. The patients included in the study were aged a mean of 57 years, 86.6% were women, 90.5% were White, 41.8% had rheumatoid arthritis (RA), 14.8% had antineutrophil cytoplasmic antibody (ANCA)-associated vasculitis, and 12.4% had psoriatic arthritis. Overall, 52.6% were on biologics or a Janus kinase (JAK) inhibitor, 30.0% were receiving methotrexate, 21.4% were taking hydroxychloroquine, and 28.6% were receiving low-dose (24.0%) or high-dose (4.6%) glucocorticoids.
Patients’ T-scores on the anxiety short form Patient-Reported Outcomes Measurement Information System (PROMIS) survey significantly decreased from a score of 58.7 in April 2020 to a score of 53.7 in May 2021 (P < .001), but there was a significant decrease in the interruption of DMARD treatment between April and December 2020 (11.2% vs. 7.5%; P < .001). This percentage rose significantly to 14.0% by May 2021 (P < .001). Patients who stopped using DMARDs were significantly associated with predicted incidence of severe flare in the next survey in adjusted models (12.9% vs. 8.0%; odds ratio, 1.71; 95% confidence interval, 1.23-2.36).
The results tell us “that we as a discipline are not doing a good job educating our patients,” said Dr. Cush, a rheumatologist based in Dallas, Tex., and executive editor of RheumNow.com.
“I wish we – and I’m really talking about myself – but myself and my practice were more proactive when COVID happened [in] sending out regular bulletins: ‘Don’t stop your therapy; these are the things you get; get the test that you need to get done,’ ” he said. “We let a lot of things go on autopilot with the patient driving throughout COVID. Even now, it’s happening. And this is a problem, and there are going to be consequences to this.”
Dr. Kavanaugh agreed with Dr. Cush’s assessment, suggesting that the pandemic came up quickly enough that it was difficult to be proactive with the situation.
Patients on JAK inhibitors as new COVID-19 risk group?
Another standout study on COVID-19 from 2021 was an analysis of the COVID-19 Global Rheumatology Alliance physician registry that examined risk of COVID-19 severity for patients with RA taking biologic or targeted synthetic DMARDs (tsDMARDs), which was presented at the 2021 EULAR congress and later published in Annals of the Rheumatic Diseases.
The researchers evaluated 2,869 patients March 2020 and April 2021 who were receiving abatacept (237 patients), rituximab (364 patients), interleukin (IL)-6 inhibitors (317 patients), JAK inhibitors (563 patients), or tumor necrosis factor (TNF) inhibitors such as infliximab, etanercept, adalimumab, certolizumab pegol, and golimumab (1,388 patients) before developing COVID-19. Data about biologics or tsDMARDs were collected as a drug class. Patients in the study were mostly White (69.0%) women (80.8%) with a mean age of 56.7 years who lived in Europe (51.8%) or North America (35.0%). The researchers examined the severity of COVID-19 among all patients studied and calculated odds ratios based on drug class, with the TNF inhibitor group serving as a reference.
“[I]n this case, they said that the baseline use of rituximab was associated with more severity, and you see the severity being hospitalization and ICU and deaths. They found a signal for the JAK inhibitors that is not found in the other studies,” Dr. Kavanaugh said.
Overall, they found 21% of patients in the registry were hospitalized and 5.5% died, with rituximab (OR, 4.15; 95% CI, 3.16-5.44) and JAK inhibitors (OR, 2.06; 95% CI, 1.60-2.65) associated with more severe COVID-19 outcomes. Specifically, rituximab was associated with greater likelihood of hospitalization (OR, 4.53; 95% CI, 3.32-6.18), hospitalization with oxygen/ventilation (OR, 2.87; 95% CI, 2.03-4.06), need for mechanical ventilation (OR, 4.05; 95% CI, 3.08-5.33), and mortality (OR, 4.57; 95% CI, 3.32-9.01), compared with TNF inhibitors. For JAK inhibitors, there was also a greater likelihood of hospitalization (OR, 2.40; 95% CI, 1.78-3.24), hospitalization with oxygen/ventilation (OR, 1.55; 95% CI, 1.04-2.18), need for mechanical ventilation (OR, 2.03; 95% CI, 1.56-2.62), and mortality (OR, 2.04; 95% CI, 1.58-2.65), compared with the TNF inhibitors group. Associations between COVID-19 severity and abatacept or IL-6 inhibitors were not identified.
Commenting on the study in a question-and-answer session, Roy Fleischmann, MD, said the part of the study that identified a signal for JAK inhibitors was “very interesting.” He called attention to a rapid response comment to the study, which questioned if it was the drug class itself that caused the risk for severe disease. “This is very important, because actually, the patients who stop the JAK [inhibitor], that’s what drove the illness. The patients [who] continued the JAK [inhibitor], very few of them had illness,” said Dr. Fleischmann, clinical professor of medicine at the University of Texas Southwestern Medical School and codirector of the Metroplex Clinical Research Center, both in Dallas, Tex.
Confusion among patients during COVID-19
Alvin Wells, MD, PhD, asked the copresenters during the Q&A session whether they had any clinical pearls for the audience on how they manage treatment of patients with rheumatic disease with potential COVID-19 risk. “I think the confusion with our patients and COVID is what the ACR has put out with their guidelines,” said Dr. Wells, director of the department of rheumatology at Advocate Aurora Health in Franklin, Wisc.
Dr. Cush said he has three rules he follows: lower and discontinue steroids, avoid rituximab as a starting treatment and negotiate if patients are already taking it, and don’t stop any therapy.
“I want disease control. I think being under control is what keeps you away from risk of COVID and hospitalization,” Dr. Cush said. “I think being uncontrolled and inflamed, whether it’s our [patients with] inflammatory arthritis or lupus or, worse, vasculitis [or] myositis, those are the ones at high risk of progression from being just infected to being sick and in the hospital.”
Eric Ruderman, MD, professor of rheumatology at Northwestern University, Chicago, posed the question of getting somewhat back to normal during COVID-19 with regard to recently infected patients presenting at infusion centers, whether patients are more likely to continue testing positive, and when patients are cleared to come back. Dr. Ruderman said his center has a 20-day rule for returning after having COVID-19, while Dr. Cush said his center allows patients to come in if they test negative after 7-10 days.
“One of the things we’re struggling with is our infusion center, and one of the questions that keeps coming up is when can people come back after a COVID infection?” he said. “If you’re on a drug at home, that’s up to you and the patient. But in the infusion [center], then you have other people sitting around there.”
Dr. Kavanaugh said there is no current data for how long patients with rheumatic disease shed virus, or how long a positive test can be measured. “You definitely will continue to shed, and you’ll be detectable for a while,” he said.
Dr. Cush and Dr. Kavanaugh reported having financial relationships with numerous pharmaceutical companies.
The COVID-19 pandemic led to a decrease in the proportion of patients with rheumatic diseases who stopped taking their disease-modifying antirheumatic drugs (DMARDs), but the percentage who interrupted DMARD treatment increased later in the pandemic, according to speakers at the 2022 Rheumatology Winter Clinical Symposium.
“People seem to be less anxious, but they’re interrupting their DMARD therapy more, more recently than in the pits of COVID, if you will,” said Arthur Kavanaugh, MD, professor of medicine at the University of California, San Diego, and director of RWCS.
Dr. Kavanaugh and his copresenter Jack Cush, MD, were discussing the results of a recent study published in Arthritis Care & Research that evaluated 2,424 patients with rheumatic diseases who completed a baseline and at least one follow-up survey issued by patient organizations between March 2020 and May 2021, with a median of five follow-up surveys completed. The patients included in the study were aged a mean of 57 years, 86.6% were women, 90.5% were White, 41.8% had rheumatoid arthritis (RA), 14.8% had antineutrophil cytoplasmic antibody (ANCA)-associated vasculitis, and 12.4% had psoriatic arthritis. Overall, 52.6% were on biologics or a Janus kinase (JAK) inhibitor, 30.0% were receiving methotrexate, 21.4% were taking hydroxychloroquine, and 28.6% were receiving low-dose (24.0%) or high-dose (4.6%) glucocorticoids.
Patients’ T-scores on the anxiety short form Patient-Reported Outcomes Measurement Information System (PROMIS) survey significantly decreased from a score of 58.7 in April 2020 to a score of 53.7 in May 2021 (P < .001), but there was a significant decrease in the interruption of DMARD treatment between April and December 2020 (11.2% vs. 7.5%; P < .001). This percentage rose significantly to 14.0% by May 2021 (P < .001). Patients who stopped using DMARDs were significantly associated with predicted incidence of severe flare in the next survey in adjusted models (12.9% vs. 8.0%; odds ratio, 1.71; 95% confidence interval, 1.23-2.36).
The results tell us “that we as a discipline are not doing a good job educating our patients,” said Dr. Cush, a rheumatologist based in Dallas, Tex., and executive editor of RheumNow.com.
“I wish we – and I’m really talking about myself – but myself and my practice were more proactive when COVID happened [in] sending out regular bulletins: ‘Don’t stop your therapy; these are the things you get; get the test that you need to get done,’ ” he said. “We let a lot of things go on autopilot with the patient driving throughout COVID. Even now, it’s happening. And this is a problem, and there are going to be consequences to this.”
Dr. Kavanaugh agreed with Dr. Cush’s assessment, suggesting that the pandemic came up quickly enough that it was difficult to be proactive with the situation.
Patients on JAK inhibitors as new COVID-19 risk group?
Another standout study on COVID-19 from 2021 was an analysis of the COVID-19 Global Rheumatology Alliance physician registry that examined risk of COVID-19 severity for patients with RA taking biologic or targeted synthetic DMARDs (tsDMARDs), which was presented at the 2021 EULAR congress and later published in Annals of the Rheumatic Diseases.
The researchers evaluated 2,869 patients March 2020 and April 2021 who were receiving abatacept (237 patients), rituximab (364 patients), interleukin (IL)-6 inhibitors (317 patients), JAK inhibitors (563 patients), or tumor necrosis factor (TNF) inhibitors such as infliximab, etanercept, adalimumab, certolizumab pegol, and golimumab (1,388 patients) before developing COVID-19. Data about biologics or tsDMARDs were collected as a drug class. Patients in the study were mostly White (69.0%) women (80.8%) with a mean age of 56.7 years who lived in Europe (51.8%) or North America (35.0%). The researchers examined the severity of COVID-19 among all patients studied and calculated odds ratios based on drug class, with the TNF inhibitor group serving as a reference.
“[I]n this case, they said that the baseline use of rituximab was associated with more severity, and you see the severity being hospitalization and ICU and deaths. They found a signal for the JAK inhibitors that is not found in the other studies,” Dr. Kavanaugh said.
Overall, they found 21% of patients in the registry were hospitalized and 5.5% died, with rituximab (OR, 4.15; 95% CI, 3.16-5.44) and JAK inhibitors (OR, 2.06; 95% CI, 1.60-2.65) associated with more severe COVID-19 outcomes. Specifically, rituximab was associated with greater likelihood of hospitalization (OR, 4.53; 95% CI, 3.32-6.18), hospitalization with oxygen/ventilation (OR, 2.87; 95% CI, 2.03-4.06), need for mechanical ventilation (OR, 4.05; 95% CI, 3.08-5.33), and mortality (OR, 4.57; 95% CI, 3.32-9.01), compared with TNF inhibitors. For JAK inhibitors, there was also a greater likelihood of hospitalization (OR, 2.40; 95% CI, 1.78-3.24), hospitalization with oxygen/ventilation (OR, 1.55; 95% CI, 1.04-2.18), need for mechanical ventilation (OR, 2.03; 95% CI, 1.56-2.62), and mortality (OR, 2.04; 95% CI, 1.58-2.65), compared with the TNF inhibitors group. Associations between COVID-19 severity and abatacept or IL-6 inhibitors were not identified.
Commenting on the study in a question-and-answer session, Roy Fleischmann, MD, said the part of the study that identified a signal for JAK inhibitors was “very interesting.” He called attention to a rapid response comment to the study, which questioned if it was the drug class itself that caused the risk for severe disease. “This is very important, because actually, the patients who stop the JAK [inhibitor], that’s what drove the illness. The patients [who] continued the JAK [inhibitor], very few of them had illness,” said Dr. Fleischmann, clinical professor of medicine at the University of Texas Southwestern Medical School and codirector of the Metroplex Clinical Research Center, both in Dallas, Tex.
Confusion among patients during COVID-19
Alvin Wells, MD, PhD, asked the copresenters during the Q&A session whether they had any clinical pearls for the audience on how they manage treatment of patients with rheumatic disease with potential COVID-19 risk. “I think the confusion with our patients and COVID is what the ACR has put out with their guidelines,” said Dr. Wells, director of the department of rheumatology at Advocate Aurora Health in Franklin, Wisc.
Dr. Cush said he has three rules he follows: lower and discontinue steroids, avoid rituximab as a starting treatment and negotiate if patients are already taking it, and don’t stop any therapy.
“I want disease control. I think being under control is what keeps you away from risk of COVID and hospitalization,” Dr. Cush said. “I think being uncontrolled and inflamed, whether it’s our [patients with] inflammatory arthritis or lupus or, worse, vasculitis [or] myositis, those are the ones at high risk of progression from being just infected to being sick and in the hospital.”
Eric Ruderman, MD, professor of rheumatology at Northwestern University, Chicago, posed the question of getting somewhat back to normal during COVID-19 with regard to recently infected patients presenting at infusion centers, whether patients are more likely to continue testing positive, and when patients are cleared to come back. Dr. Ruderman said his center has a 20-day rule for returning after having COVID-19, while Dr. Cush said his center allows patients to come in if they test negative after 7-10 days.
“One of the things we’re struggling with is our infusion center, and one of the questions that keeps coming up is when can people come back after a COVID infection?” he said. “If you’re on a drug at home, that’s up to you and the patient. But in the infusion [center], then you have other people sitting around there.”
Dr. Kavanaugh said there is no current data for how long patients with rheumatic disease shed virus, or how long a positive test can be measured. “You definitely will continue to shed, and you’ll be detectable for a while,” he said.
Dr. Cush and Dr. Kavanaugh reported having financial relationships with numerous pharmaceutical companies.
FROM RWCS 2022
Thirty-seven percent of COVID-19 patients lose sense of taste, study says
, according to a new study.
Many COVID-19 patients report losing their sense of taste as well as their sense of smell, but scientists have been skeptical because the two senses are closely related and it was relatively rare for people to lose their taste sense before the COVID pandemic, says the Monell Chemical Senses Center, a nonprofit research institute in Philadelphia.
But a new Monell Center analysis found that 37% – or about four in every 10 -- of COVID-19 patients actually did lose their sense of taste and that “reports of taste loss are in fact genuine and distinguishable from smell loss.”
Taste dysfunction can be total taste loss, partial taste loss, and taste distortion. It’s an “underrated” symptom that could help doctors better treat COVID patients, the Monell Center said in a news release.
“It is time to turn to the tongue” to learn why taste is affected and to start on how to reverse or repair the loss, said Mackenzie Hannum, PhD, an author of the report and a postdoctoral fellow in the lab of Danielle Reed, PhD.
Researchers looked at data regarding 138,785 COVID patients from 241 studies that assessed taste loss and were published between May 15, 2020, and June 1, 2021. Of those patients, 32,918 said they had some form of taste loss. Further, female patients were more likely than males to lose their sense of taste, and people 36-50 years old had the highest rate of taste loss.
The information came from self-reports and direct reports.
“Self-reports are more subjective and can be in the form of questionnaires, interviews, health records, for example,” Dr. Hannum said. “On the other hand, direct measures of taste are more objective. They are conducted using testing kits that contain various sweet, salty, and sometimes bitter and sour solutions given to participants via drops, strips, or sprays.”
Though self-reports were subjective, they proved just as good as direct reports at detecting taste loss, the study said.
“Here self-reports are backed up by direct measures, proving that loss of taste is a real, distinct symptom of COVID-19 that is not to be confused with smell loss,” said study co-author Vicente Ramirez, a visiting scientist at Monell and a doctoral student at the University of California, Merced.
A version of this article first appeared on WebMD.com.
, according to a new study.
Many COVID-19 patients report losing their sense of taste as well as their sense of smell, but scientists have been skeptical because the two senses are closely related and it was relatively rare for people to lose their taste sense before the COVID pandemic, says the Monell Chemical Senses Center, a nonprofit research institute in Philadelphia.
But a new Monell Center analysis found that 37% – or about four in every 10 -- of COVID-19 patients actually did lose their sense of taste and that “reports of taste loss are in fact genuine and distinguishable from smell loss.”
Taste dysfunction can be total taste loss, partial taste loss, and taste distortion. It’s an “underrated” symptom that could help doctors better treat COVID patients, the Monell Center said in a news release.
“It is time to turn to the tongue” to learn why taste is affected and to start on how to reverse or repair the loss, said Mackenzie Hannum, PhD, an author of the report and a postdoctoral fellow in the lab of Danielle Reed, PhD.
Researchers looked at data regarding 138,785 COVID patients from 241 studies that assessed taste loss and were published between May 15, 2020, and June 1, 2021. Of those patients, 32,918 said they had some form of taste loss. Further, female patients were more likely than males to lose their sense of taste, and people 36-50 years old had the highest rate of taste loss.
The information came from self-reports and direct reports.
“Self-reports are more subjective and can be in the form of questionnaires, interviews, health records, for example,” Dr. Hannum said. “On the other hand, direct measures of taste are more objective. They are conducted using testing kits that contain various sweet, salty, and sometimes bitter and sour solutions given to participants via drops, strips, or sprays.”
Though self-reports were subjective, they proved just as good as direct reports at detecting taste loss, the study said.
“Here self-reports are backed up by direct measures, proving that loss of taste is a real, distinct symptom of COVID-19 that is not to be confused with smell loss,” said study co-author Vicente Ramirez, a visiting scientist at Monell and a doctoral student at the University of California, Merced.
A version of this article first appeared on WebMD.com.
, according to a new study.
Many COVID-19 patients report losing their sense of taste as well as their sense of smell, but scientists have been skeptical because the two senses are closely related and it was relatively rare for people to lose their taste sense before the COVID pandemic, says the Monell Chemical Senses Center, a nonprofit research institute in Philadelphia.
But a new Monell Center analysis found that 37% – or about four in every 10 -- of COVID-19 patients actually did lose their sense of taste and that “reports of taste loss are in fact genuine and distinguishable from smell loss.”
Taste dysfunction can be total taste loss, partial taste loss, and taste distortion. It’s an “underrated” symptom that could help doctors better treat COVID patients, the Monell Center said in a news release.
“It is time to turn to the tongue” to learn why taste is affected and to start on how to reverse or repair the loss, said Mackenzie Hannum, PhD, an author of the report and a postdoctoral fellow in the lab of Danielle Reed, PhD.
Researchers looked at data regarding 138,785 COVID patients from 241 studies that assessed taste loss and were published between May 15, 2020, and June 1, 2021. Of those patients, 32,918 said they had some form of taste loss. Further, female patients were more likely than males to lose their sense of taste, and people 36-50 years old had the highest rate of taste loss.
The information came from self-reports and direct reports.
“Self-reports are more subjective and can be in the form of questionnaires, interviews, health records, for example,” Dr. Hannum said. “On the other hand, direct measures of taste are more objective. They are conducted using testing kits that contain various sweet, salty, and sometimes bitter and sour solutions given to participants via drops, strips, or sprays.”
Though self-reports were subjective, they proved just as good as direct reports at detecting taste loss, the study said.
“Here self-reports are backed up by direct measures, proving that loss of taste is a real, distinct symptom of COVID-19 that is not to be confused with smell loss,” said study co-author Vicente Ramirez, a visiting scientist at Monell and a doctoral student at the University of California, Merced.
A version of this article first appeared on WebMD.com.
FROM CHEMICAL SENSES
Babies better protected from COVID if mother vaccinated during pregnancy: study
In a first of its kind study, researchers found women who received two mRNA COVID vaccine doses during pregnancy were 61% less likely to have a baby hospitalized for COVID-19 during the first 6 months of life.
In addition, two doses of the Pfizer/BioNTech or Moderna COVID vaccine later in a pregnancy were linked to an even higher level of protection, 80%, compared with 32% when given before 20 weeks’ gestation.
This finding suggests a greater transfer of maternal antibodies closer to birth, but more research is needed, cautioned senior study author Manish Patel, MD, during a Tuesday media telebriefing held by the Centers for Disease Control and Prevention.
Unanswered questions include how the babies got infected or if there is any protection afforded to babies for women vaccinated before pregnancy.
“We cannot be sure about the source of the infection,” said Dr. Patel, a medical epidemiologist with the CDC COVID-19 Emergency Response Team.
Dana Meaney-Delman, MD, MPH, agreed, but added that “perinatal transmission of the virus is very rare” with SARS-CoV-2. She is a practicing obstetrician and gynecologist and chief of the CDC Infant Outcomes Monitoring Research and Prevention Branch.
The study numbers were too small to show if a booster shot during pregnancy or breastfeeding could provide even greater protection for babies, Dr. Patel said.
The early release study was published online Feb. 15 in the CDC’s Morbidity and Mortality Weekly Report (MMWR).
Many previous studies looking at COVID-19 immunization during pregnancy focused on maternal health and “have clearly shown that receiving an mRNA COVID-19 vaccine during pregnancy reduces the risk for severe illness,” Dr. Meaney-Delman said.
Some dual protection suggested
Now there is evidence for a potential benefit to babies as well when a pregnant woman gets vaccinated. The study “provides real-world evidence that getting COVID-19 vaccination during pregnancy might help protect infants less than 6 months [of age],” Dr. Meaney-Delman said.
“These findings continue to emphasize the importance of COVID-19 vaccination during pregnancy to protect people who are pregnant and also to protect their babies,” she said.
Dr. Patel and colleagues studied 379 infants younger than 6 months hospitalized between July 1, 2021 and Jan. 17 of this year. Delta and then the Omicron variant predominated during this time.
The infants were admitted to one of 20 children’s hospitals in 17 states. The researchers compared 176 infants admitted with a positive COVID-19 PCR test to another 203 infants with a negative PCR test who served as controls.
Half as many mothers of infants admitted with COVID-19 were vaccinated during pregnancy, 16%, versus 32% of mothers of the control infants.
Vaccination with two doses of mRNA vaccine during pregnancy was 61% effective (95% confidence interval, 31%-78%) at preventing hospitalization among these infants. Because the study was epidemiological, the lower risk was an association, not a cause-and-effect finding, Dr. Patel said.
Babies admitted to the hospital positive for COVID-19 were more likely to be non-Hispanic Black, 18%, versus 9% of control group babies; and more likely to be Hispanic, 34% versus 28%, respectively.
A total 24% of infants with COVID-19 were admitted to the ICU, including the baby of an unvaccinated mother who required extracorporeal membrane oxygenation (ECMO). Another baby of an unvaccinated mother was the only infant death during the study.
Maternal vaccination trends
A reporter pointed out that COVID-19 vaccination rates tend to be low among pregnant women. “So there is some exciting news,” Dr. Meaney-Delman said, referring to a steady increase in the percentages of pregnant women in the U.S. choosing to get vaccinated, according to the CDC Data Tracker website.
“The numbers are encouraging, [but] they’re not quite where we need them to be, and they do differ by race and ethnicity,” she added.
A version of this article first appeared on Medscape.com.
In a first of its kind study, researchers found women who received two mRNA COVID vaccine doses during pregnancy were 61% less likely to have a baby hospitalized for COVID-19 during the first 6 months of life.
In addition, two doses of the Pfizer/BioNTech or Moderna COVID vaccine later in a pregnancy were linked to an even higher level of protection, 80%, compared with 32% when given before 20 weeks’ gestation.
This finding suggests a greater transfer of maternal antibodies closer to birth, but more research is needed, cautioned senior study author Manish Patel, MD, during a Tuesday media telebriefing held by the Centers for Disease Control and Prevention.
Unanswered questions include how the babies got infected or if there is any protection afforded to babies for women vaccinated before pregnancy.
“We cannot be sure about the source of the infection,” said Dr. Patel, a medical epidemiologist with the CDC COVID-19 Emergency Response Team.
Dana Meaney-Delman, MD, MPH, agreed, but added that “perinatal transmission of the virus is very rare” with SARS-CoV-2. She is a practicing obstetrician and gynecologist and chief of the CDC Infant Outcomes Monitoring Research and Prevention Branch.
The study numbers were too small to show if a booster shot during pregnancy or breastfeeding could provide even greater protection for babies, Dr. Patel said.
The early release study was published online Feb. 15 in the CDC’s Morbidity and Mortality Weekly Report (MMWR).
Many previous studies looking at COVID-19 immunization during pregnancy focused on maternal health and “have clearly shown that receiving an mRNA COVID-19 vaccine during pregnancy reduces the risk for severe illness,” Dr. Meaney-Delman said.
Some dual protection suggested
Now there is evidence for a potential benefit to babies as well when a pregnant woman gets vaccinated. The study “provides real-world evidence that getting COVID-19 vaccination during pregnancy might help protect infants less than 6 months [of age],” Dr. Meaney-Delman said.
“These findings continue to emphasize the importance of COVID-19 vaccination during pregnancy to protect people who are pregnant and also to protect their babies,” she said.
Dr. Patel and colleagues studied 379 infants younger than 6 months hospitalized between July 1, 2021 and Jan. 17 of this year. Delta and then the Omicron variant predominated during this time.
The infants were admitted to one of 20 children’s hospitals in 17 states. The researchers compared 176 infants admitted with a positive COVID-19 PCR test to another 203 infants with a negative PCR test who served as controls.
Half as many mothers of infants admitted with COVID-19 were vaccinated during pregnancy, 16%, versus 32% of mothers of the control infants.
Vaccination with two doses of mRNA vaccine during pregnancy was 61% effective (95% confidence interval, 31%-78%) at preventing hospitalization among these infants. Because the study was epidemiological, the lower risk was an association, not a cause-and-effect finding, Dr. Patel said.
Babies admitted to the hospital positive for COVID-19 were more likely to be non-Hispanic Black, 18%, versus 9% of control group babies; and more likely to be Hispanic, 34% versus 28%, respectively.
A total 24% of infants with COVID-19 were admitted to the ICU, including the baby of an unvaccinated mother who required extracorporeal membrane oxygenation (ECMO). Another baby of an unvaccinated mother was the only infant death during the study.
Maternal vaccination trends
A reporter pointed out that COVID-19 vaccination rates tend to be low among pregnant women. “So there is some exciting news,” Dr. Meaney-Delman said, referring to a steady increase in the percentages of pregnant women in the U.S. choosing to get vaccinated, according to the CDC Data Tracker website.
“The numbers are encouraging, [but] they’re not quite where we need them to be, and they do differ by race and ethnicity,” she added.
A version of this article first appeared on Medscape.com.
In a first of its kind study, researchers found women who received two mRNA COVID vaccine doses during pregnancy were 61% less likely to have a baby hospitalized for COVID-19 during the first 6 months of life.
In addition, two doses of the Pfizer/BioNTech or Moderna COVID vaccine later in a pregnancy were linked to an even higher level of protection, 80%, compared with 32% when given before 20 weeks’ gestation.
This finding suggests a greater transfer of maternal antibodies closer to birth, but more research is needed, cautioned senior study author Manish Patel, MD, during a Tuesday media telebriefing held by the Centers for Disease Control and Prevention.
Unanswered questions include how the babies got infected or if there is any protection afforded to babies for women vaccinated before pregnancy.
“We cannot be sure about the source of the infection,” said Dr. Patel, a medical epidemiologist with the CDC COVID-19 Emergency Response Team.
Dana Meaney-Delman, MD, MPH, agreed, but added that “perinatal transmission of the virus is very rare” with SARS-CoV-2. She is a practicing obstetrician and gynecologist and chief of the CDC Infant Outcomes Monitoring Research and Prevention Branch.
The study numbers were too small to show if a booster shot during pregnancy or breastfeeding could provide even greater protection for babies, Dr. Patel said.
The early release study was published online Feb. 15 in the CDC’s Morbidity and Mortality Weekly Report (MMWR).
Many previous studies looking at COVID-19 immunization during pregnancy focused on maternal health and “have clearly shown that receiving an mRNA COVID-19 vaccine during pregnancy reduces the risk for severe illness,” Dr. Meaney-Delman said.
Some dual protection suggested
Now there is evidence for a potential benefit to babies as well when a pregnant woman gets vaccinated. The study “provides real-world evidence that getting COVID-19 vaccination during pregnancy might help protect infants less than 6 months [of age],” Dr. Meaney-Delman said.
“These findings continue to emphasize the importance of COVID-19 vaccination during pregnancy to protect people who are pregnant and also to protect their babies,” she said.
Dr. Patel and colleagues studied 379 infants younger than 6 months hospitalized between July 1, 2021 and Jan. 17 of this year. Delta and then the Omicron variant predominated during this time.
The infants were admitted to one of 20 children’s hospitals in 17 states. The researchers compared 176 infants admitted with a positive COVID-19 PCR test to another 203 infants with a negative PCR test who served as controls.
Half as many mothers of infants admitted with COVID-19 were vaccinated during pregnancy, 16%, versus 32% of mothers of the control infants.
Vaccination with two doses of mRNA vaccine during pregnancy was 61% effective (95% confidence interval, 31%-78%) at preventing hospitalization among these infants. Because the study was epidemiological, the lower risk was an association, not a cause-and-effect finding, Dr. Patel said.
Babies admitted to the hospital positive for COVID-19 were more likely to be non-Hispanic Black, 18%, versus 9% of control group babies; and more likely to be Hispanic, 34% versus 28%, respectively.
A total 24% of infants with COVID-19 were admitted to the ICU, including the baby of an unvaccinated mother who required extracorporeal membrane oxygenation (ECMO). Another baby of an unvaccinated mother was the only infant death during the study.
Maternal vaccination trends
A reporter pointed out that COVID-19 vaccination rates tend to be low among pregnant women. “So there is some exciting news,” Dr. Meaney-Delman said, referring to a steady increase in the percentages of pregnant women in the U.S. choosing to get vaccinated, according to the CDC Data Tracker website.
“The numbers are encouraging, [but] they’re not quite where we need them to be, and they do differ by race and ethnicity,” she added.
A version of this article first appeared on Medscape.com.
CDC preparing to update mask guidance
, CDC Director Rochelle P. Walensky, MD, said on Feb. 16.
“As we consider future metrics, which will be updated soon, we recognize the importance of not just cases … but critically, medically severe disease that leads to hospitalizations,” Dr. Walensky said at a White House news briefing. “We must consider hospital capacity as an additional important barometer.”
She later added, “We are looking at an overview of much of our guidance, and masking in all settings will be a part of that.”
Coronavirus cases continue to drop nationwide. This week’s 7-day daily average of cases is 147,000, a decrease of 40%. Hospitalizations have dropped 28% to 9,500, and daily deaths are 2,200, a decrease of 9%.
“Omicron cases are declining, and we are all cautiously optimistic about the trajectory we’re on,” Dr. Walensky said. “Things are moving in the right direction, but we want to remain vigilant to do all we can so this trajectory continues.”
Dr. Walensky said public masking remains especially important if someone is symptomatic or not feeling well, or if there has been a COVID-19 exposure. Those who are within 10 days of being diagnosed with the virus should also remain masked in public.
“We all share the same goal: to get to a point where COVID-19 is no longer disrupting our daily lives. A time when it won’t be a constant crisis,” Dr. Walensky said. “Moving from this pandemic will be a process led by science and epidemiological trends, and one that relies on the powerful tools we already have.”
A version of this article first appeared on WebMD.com.
, CDC Director Rochelle P. Walensky, MD, said on Feb. 16.
“As we consider future metrics, which will be updated soon, we recognize the importance of not just cases … but critically, medically severe disease that leads to hospitalizations,” Dr. Walensky said at a White House news briefing. “We must consider hospital capacity as an additional important barometer.”
She later added, “We are looking at an overview of much of our guidance, and masking in all settings will be a part of that.”
Coronavirus cases continue to drop nationwide. This week’s 7-day daily average of cases is 147,000, a decrease of 40%. Hospitalizations have dropped 28% to 9,500, and daily deaths are 2,200, a decrease of 9%.
“Omicron cases are declining, and we are all cautiously optimistic about the trajectory we’re on,” Dr. Walensky said. “Things are moving in the right direction, but we want to remain vigilant to do all we can so this trajectory continues.”
Dr. Walensky said public masking remains especially important if someone is symptomatic or not feeling well, or if there has been a COVID-19 exposure. Those who are within 10 days of being diagnosed with the virus should also remain masked in public.
“We all share the same goal: to get to a point where COVID-19 is no longer disrupting our daily lives. A time when it won’t be a constant crisis,” Dr. Walensky said. “Moving from this pandemic will be a process led by science and epidemiological trends, and one that relies on the powerful tools we already have.”
A version of this article first appeared on WebMD.com.
, CDC Director Rochelle P. Walensky, MD, said on Feb. 16.
“As we consider future metrics, which will be updated soon, we recognize the importance of not just cases … but critically, medically severe disease that leads to hospitalizations,” Dr. Walensky said at a White House news briefing. “We must consider hospital capacity as an additional important barometer.”
She later added, “We are looking at an overview of much of our guidance, and masking in all settings will be a part of that.”
Coronavirus cases continue to drop nationwide. This week’s 7-day daily average of cases is 147,000, a decrease of 40%. Hospitalizations have dropped 28% to 9,500, and daily deaths are 2,200, a decrease of 9%.
“Omicron cases are declining, and we are all cautiously optimistic about the trajectory we’re on,” Dr. Walensky said. “Things are moving in the right direction, but we want to remain vigilant to do all we can so this trajectory continues.”
Dr. Walensky said public masking remains especially important if someone is symptomatic or not feeling well, or if there has been a COVID-19 exposure. Those who are within 10 days of being diagnosed with the virus should also remain masked in public.
“We all share the same goal: to get to a point where COVID-19 is no longer disrupting our daily lives. A time when it won’t be a constant crisis,” Dr. Walensky said. “Moving from this pandemic will be a process led by science and epidemiological trends, and one that relies on the powerful tools we already have.”
A version of this article first appeared on WebMD.com.
Stroke risk is highest right after COVID infection
, new research shows.
The study among Medicare beneficiaries with COVID-19 also showed that stroke risk is higher for relatively young older adults, those aged 65 to 74 years, and those without a history of stroke.
The study highlights the impact COVID-19 has on the cardiovascular system, said study author Quanhe Yang, PhD, senior scientist, Division for Heart Disease and Stroke Prevention, Centers for Disease Control and Prevention, Atlanta.
“Clinicians and patients should understand that stroke might be one of the very important clinical consequences of COVID-19.”
The study was presented during the hybrid International Stroke Conference held in New Orleans and online. The meeting was presented by the American Stroke Association, a division of the American Heart Association.
Stroke is the fifth leading cause of death in the U.S. As an increasing number of people become infected with COVID-19, “it’s important to determine if there’s a relationship between COVID and the risk of stroke,” said Dr. Yang.
Findings from prior research examining the link between stroke and COVID-19 have been inconsistent, he noted. Some studies found an association while others did not, and in still others, the association was not as strong as expected.
Many factors may contribute to these inconsistent findings, said Dr. Yang, including differences in study design, inclusion criteria, comparison groups, sample sizes, and countries where the research was carried out. Dr. Yang pointed out that many of these studies were done in the early stages of the pandemic or didn’t include older adults, the population most at risk for stroke.
The current study included 19,553 Medicare beneficiaries aged 65 years and older diagnosed with COVID-19 and hospitalized with acute ischemic stroke. The median age at diagnosis of COVID-19 was 80.5 years, 57.5% were women, and more than 75% were non-Hispanic Whites.
To ensure the stroke occurred after a COVID infection, researchers used a self-controlled case series study design, a “within person” comparison between the risk period and the control period.
They divided the study period (Jan. 1, 2019 to Feb. 28, 2021) into the exposure or stroke risk periods after the COVID diagnosis (0-3 days; 4-7 days; 8-15 days; and 15-28 days) and control periods.
Strokes that occurred 7 days before or 28 days after a COVID diagnosis served as a control period. “Any stroke that occurred outside the risk window is in the control period,” explained Dr. Yang.
He added that the control period provides a baseline. “Without COVID-19, this is what I would expect” in terms of the number of strokes.
To estimate the incidence rate ratio (IRR), investigators compared the incidence of acute ischemic stroke in the various risk periods with control periods.
The IRR was 10.97 (95% confidence interval, 10.30-11.68) at 0-3 days. The risk then quickly declined but stayed higher than the control period. The IRRs were: 1.59 (95% CI, 1.35-1.87) at 4-7 days; 1.23 (95% CI, 1.07-1.41) at 8-14 days; and 1.06 (95% CI, 0.95-1.18) at 15-28 days.
The temporary increase in stroke risk early after an infection isn’t novel; the pattern has been observed with influenza, respiratory infections, and shingles, said Dr. Yang. “But COVID-19 appears to be particularly risky.”
Although the mechanism driving the early increased stroke risk isn’t fully understood, it’s likely tied to an “exaggerated inflammatory response,” said Dr. Yang. This can trigger the cascade of events setting the stage for a stroke – a hypercoagulation state leading to the formation of blood clots that then block arteries to the brain, he said.
It’s also possible the infection directly affects endothelial cells, leading to rupture of plaque, again blocking arteries and raising stroke risks, added Dr. Yang.
The association was stronger among younger beneficiaries, aged 65 to 74 years, compared with those 85 years and older, a finding Dr. Yang said was somewhat surprising. But he noted other studies have found stroke patients with COVID are younger than stroke patients without COVID – by some 5 to 6 years.
“If COVID-19 disproportionately affects younger patients, that may explain the stronger association,” said Dr. Yang. “Stroke risk increases tremendously with age, so if you’re a younger age, your baseline stroke risk is lower.”
The association was also stronger among beneficiaries without a history of stroke. Again, this could be related to the stronger association among younger patients who are less likely to have suffered a stroke. The association was largely consistent across sex and race/ethnicities.
Dr. Yang stressed that the findings need to be confirmed with further studies.
The study was carried out before widespread use of vaccinations in the U.S. Once those data are available, Dr. Yang and his colleagues plan to determine if vaccinations modify the association between COVID-19 and stroke risk.
The new results contribute to the mounting evidence that a COVID-19 infection “can actually affect multiple human organs structurally or functionally in addition to the impact on [the] respiratory system,” said Dr. Yang.
Some dates of COVID-19 diagnoses may be incorrect due to limited test availability, particularly early in the pandemic. Another limitation of the study was possible misclassification from the use of Medicare real-time preliminary claims.
In a provided statement, Louise D. McCullough, MD, PhD, chair of the ISC 2022 and professor and chair of neurology, McGovern Medical School, University of Texas Health Science Center at Houston, noted that the study focused on older adults because it was examining Medicare beneficiaries.
“But everyone is likely at risk for stroke after COVID,” she said. “Any infection is linked to stroke risk, probably because any infection will cause inflammation, and inflammation can cause clots or thrombus, which is the cause of stroke.”
There was no outside funding for the study. No relevant conflicts of interest were disclosed.
A version of this article first appeared on Medscape.com.
, new research shows.
The study among Medicare beneficiaries with COVID-19 also showed that stroke risk is higher for relatively young older adults, those aged 65 to 74 years, and those without a history of stroke.
The study highlights the impact COVID-19 has on the cardiovascular system, said study author Quanhe Yang, PhD, senior scientist, Division for Heart Disease and Stroke Prevention, Centers for Disease Control and Prevention, Atlanta.
“Clinicians and patients should understand that stroke might be one of the very important clinical consequences of COVID-19.”
The study was presented during the hybrid International Stroke Conference held in New Orleans and online. The meeting was presented by the American Stroke Association, a division of the American Heart Association.
Stroke is the fifth leading cause of death in the U.S. As an increasing number of people become infected with COVID-19, “it’s important to determine if there’s a relationship between COVID and the risk of stroke,” said Dr. Yang.
Findings from prior research examining the link between stroke and COVID-19 have been inconsistent, he noted. Some studies found an association while others did not, and in still others, the association was not as strong as expected.
Many factors may contribute to these inconsistent findings, said Dr. Yang, including differences in study design, inclusion criteria, comparison groups, sample sizes, and countries where the research was carried out. Dr. Yang pointed out that many of these studies were done in the early stages of the pandemic or didn’t include older adults, the population most at risk for stroke.
The current study included 19,553 Medicare beneficiaries aged 65 years and older diagnosed with COVID-19 and hospitalized with acute ischemic stroke. The median age at diagnosis of COVID-19 was 80.5 years, 57.5% were women, and more than 75% were non-Hispanic Whites.
To ensure the stroke occurred after a COVID infection, researchers used a self-controlled case series study design, a “within person” comparison between the risk period and the control period.
They divided the study period (Jan. 1, 2019 to Feb. 28, 2021) into the exposure or stroke risk periods after the COVID diagnosis (0-3 days; 4-7 days; 8-15 days; and 15-28 days) and control periods.
Strokes that occurred 7 days before or 28 days after a COVID diagnosis served as a control period. “Any stroke that occurred outside the risk window is in the control period,” explained Dr. Yang.
He added that the control period provides a baseline. “Without COVID-19, this is what I would expect” in terms of the number of strokes.
To estimate the incidence rate ratio (IRR), investigators compared the incidence of acute ischemic stroke in the various risk periods with control periods.
The IRR was 10.97 (95% confidence interval, 10.30-11.68) at 0-3 days. The risk then quickly declined but stayed higher than the control period. The IRRs were: 1.59 (95% CI, 1.35-1.87) at 4-7 days; 1.23 (95% CI, 1.07-1.41) at 8-14 days; and 1.06 (95% CI, 0.95-1.18) at 15-28 days.
The temporary increase in stroke risk early after an infection isn’t novel; the pattern has been observed with influenza, respiratory infections, and shingles, said Dr. Yang. “But COVID-19 appears to be particularly risky.”
Although the mechanism driving the early increased stroke risk isn’t fully understood, it’s likely tied to an “exaggerated inflammatory response,” said Dr. Yang. This can trigger the cascade of events setting the stage for a stroke – a hypercoagulation state leading to the formation of blood clots that then block arteries to the brain, he said.
It’s also possible the infection directly affects endothelial cells, leading to rupture of plaque, again blocking arteries and raising stroke risks, added Dr. Yang.
The association was stronger among younger beneficiaries, aged 65 to 74 years, compared with those 85 years and older, a finding Dr. Yang said was somewhat surprising. But he noted other studies have found stroke patients with COVID are younger than stroke patients without COVID – by some 5 to 6 years.
“If COVID-19 disproportionately affects younger patients, that may explain the stronger association,” said Dr. Yang. “Stroke risk increases tremendously with age, so if you’re a younger age, your baseline stroke risk is lower.”
The association was also stronger among beneficiaries without a history of stroke. Again, this could be related to the stronger association among younger patients who are less likely to have suffered a stroke. The association was largely consistent across sex and race/ethnicities.
Dr. Yang stressed that the findings need to be confirmed with further studies.
The study was carried out before widespread use of vaccinations in the U.S. Once those data are available, Dr. Yang and his colleagues plan to determine if vaccinations modify the association between COVID-19 and stroke risk.
The new results contribute to the mounting evidence that a COVID-19 infection “can actually affect multiple human organs structurally or functionally in addition to the impact on [the] respiratory system,” said Dr. Yang.
Some dates of COVID-19 diagnoses may be incorrect due to limited test availability, particularly early in the pandemic. Another limitation of the study was possible misclassification from the use of Medicare real-time preliminary claims.
In a provided statement, Louise D. McCullough, MD, PhD, chair of the ISC 2022 and professor and chair of neurology, McGovern Medical School, University of Texas Health Science Center at Houston, noted that the study focused on older adults because it was examining Medicare beneficiaries.
“But everyone is likely at risk for stroke after COVID,” she said. “Any infection is linked to stroke risk, probably because any infection will cause inflammation, and inflammation can cause clots or thrombus, which is the cause of stroke.”
There was no outside funding for the study. No relevant conflicts of interest were disclosed.
A version of this article first appeared on Medscape.com.
, new research shows.
The study among Medicare beneficiaries with COVID-19 also showed that stroke risk is higher for relatively young older adults, those aged 65 to 74 years, and those without a history of stroke.
The study highlights the impact COVID-19 has on the cardiovascular system, said study author Quanhe Yang, PhD, senior scientist, Division for Heart Disease and Stroke Prevention, Centers for Disease Control and Prevention, Atlanta.
“Clinicians and patients should understand that stroke might be one of the very important clinical consequences of COVID-19.”
The study was presented during the hybrid International Stroke Conference held in New Orleans and online. The meeting was presented by the American Stroke Association, a division of the American Heart Association.
Stroke is the fifth leading cause of death in the U.S. As an increasing number of people become infected with COVID-19, “it’s important to determine if there’s a relationship between COVID and the risk of stroke,” said Dr. Yang.
Findings from prior research examining the link between stroke and COVID-19 have been inconsistent, he noted. Some studies found an association while others did not, and in still others, the association was not as strong as expected.
Many factors may contribute to these inconsistent findings, said Dr. Yang, including differences in study design, inclusion criteria, comparison groups, sample sizes, and countries where the research was carried out. Dr. Yang pointed out that many of these studies were done in the early stages of the pandemic or didn’t include older adults, the population most at risk for stroke.
The current study included 19,553 Medicare beneficiaries aged 65 years and older diagnosed with COVID-19 and hospitalized with acute ischemic stroke. The median age at diagnosis of COVID-19 was 80.5 years, 57.5% were women, and more than 75% were non-Hispanic Whites.
To ensure the stroke occurred after a COVID infection, researchers used a self-controlled case series study design, a “within person” comparison between the risk period and the control period.
They divided the study period (Jan. 1, 2019 to Feb. 28, 2021) into the exposure or stroke risk periods after the COVID diagnosis (0-3 days; 4-7 days; 8-15 days; and 15-28 days) and control periods.
Strokes that occurred 7 days before or 28 days after a COVID diagnosis served as a control period. “Any stroke that occurred outside the risk window is in the control period,” explained Dr. Yang.
He added that the control period provides a baseline. “Without COVID-19, this is what I would expect” in terms of the number of strokes.
To estimate the incidence rate ratio (IRR), investigators compared the incidence of acute ischemic stroke in the various risk periods with control periods.
The IRR was 10.97 (95% confidence interval, 10.30-11.68) at 0-3 days. The risk then quickly declined but stayed higher than the control period. The IRRs were: 1.59 (95% CI, 1.35-1.87) at 4-7 days; 1.23 (95% CI, 1.07-1.41) at 8-14 days; and 1.06 (95% CI, 0.95-1.18) at 15-28 days.
The temporary increase in stroke risk early after an infection isn’t novel; the pattern has been observed with influenza, respiratory infections, and shingles, said Dr. Yang. “But COVID-19 appears to be particularly risky.”
Although the mechanism driving the early increased stroke risk isn’t fully understood, it’s likely tied to an “exaggerated inflammatory response,” said Dr. Yang. This can trigger the cascade of events setting the stage for a stroke – a hypercoagulation state leading to the formation of blood clots that then block arteries to the brain, he said.
It’s also possible the infection directly affects endothelial cells, leading to rupture of plaque, again blocking arteries and raising stroke risks, added Dr. Yang.
The association was stronger among younger beneficiaries, aged 65 to 74 years, compared with those 85 years and older, a finding Dr. Yang said was somewhat surprising. But he noted other studies have found stroke patients with COVID are younger than stroke patients without COVID – by some 5 to 6 years.
“If COVID-19 disproportionately affects younger patients, that may explain the stronger association,” said Dr. Yang. “Stroke risk increases tremendously with age, so if you’re a younger age, your baseline stroke risk is lower.”
The association was also stronger among beneficiaries without a history of stroke. Again, this could be related to the stronger association among younger patients who are less likely to have suffered a stroke. The association was largely consistent across sex and race/ethnicities.
Dr. Yang stressed that the findings need to be confirmed with further studies.
The study was carried out before widespread use of vaccinations in the U.S. Once those data are available, Dr. Yang and his colleagues plan to determine if vaccinations modify the association between COVID-19 and stroke risk.
The new results contribute to the mounting evidence that a COVID-19 infection “can actually affect multiple human organs structurally or functionally in addition to the impact on [the] respiratory system,” said Dr. Yang.
Some dates of COVID-19 diagnoses may be incorrect due to limited test availability, particularly early in the pandemic. Another limitation of the study was possible misclassification from the use of Medicare real-time preliminary claims.
In a provided statement, Louise D. McCullough, MD, PhD, chair of the ISC 2022 and professor and chair of neurology, McGovern Medical School, University of Texas Health Science Center at Houston, noted that the study focused on older adults because it was examining Medicare beneficiaries.
“But everyone is likely at risk for stroke after COVID,” she said. “Any infection is linked to stroke risk, probably because any infection will cause inflammation, and inflammation can cause clots or thrombus, which is the cause of stroke.”
There was no outside funding for the study. No relevant conflicts of interest were disclosed.
A version of this article first appeared on Medscape.com.
FROM ISC 2022