COVID-19

Key clinical point: A study has identified at least 3 modifiable behaviors that may increase the personal risk for COVID-19.

Major finding: Higher number of nonhousehold contacts (odds ratio [OR], 1.10 per 10 contacts; P = .024), attending events having at least 10 people (OR, 1.26 per 10 events; P = .007), and visiting restaurants (OR, 1.95 per 10 visits; P less than .001) were associated with a significantly increased risk for incident COVID-19.

Study details: The data come from a prospective cohort study of 28,575 individuals across 99 countries.

Disclosures: The study was supported by grants from the National Institutes of Health/National Institute of Biomedical Imaging and Bioengineering to GM Marcus, J Olgin, and M Pletcher. The authors declared no competing interests.

Source: Lin A et al. BMJ Open. 2021 Sep 21. doi: 10.1136/bmjopen-2021-052025.

Key clinical point: A study has identified at least 3 modifiable behaviors that may increase the personal risk for COVID-19.

Major finding: Higher number of nonhousehold contacts (odds ratio [OR], 1.10 per 10 contacts; P = .024), attending events having at least 10 people (OR, 1.26 per 10 events; P = .007), and visiting restaurants (OR, 1.95 per 10 visits; P less than .001) were associated with a significantly increased risk for incident COVID-19.

Study details: The data come from a prospective cohort study of 28,575 individuals across 99 countries.

Disclosures: The study was supported by grants from the National Institutes of Health/National Institute of Biomedical Imaging and Bioengineering to GM Marcus, J Olgin, and M Pletcher. The authors declared no competing interests.

Source: Lin A et al. BMJ Open. 2021 Sep 21. doi: 10.1136/bmjopen-2021-052025.

Key clinical point: A study has identified at least 3 modifiable behaviors that may increase the personal risk for COVID-19.

Major finding: Higher number of nonhousehold contacts (odds ratio [OR], 1.10 per 10 contacts; P = .024), attending events having at least 10 people (OR, 1.26 per 10 events; P = .007), and visiting restaurants (OR, 1.95 per 10 visits; P less than .001) were associated with a significantly increased risk for incident COVID-19.

Study details: The data come from a prospective cohort study of 28,575 individuals across 99 countries.

Disclosures: The study was supported by grants from the National Institutes of Health/National Institute of Biomedical Imaging and Bioengineering to GM Marcus, J Olgin, and M Pletcher. The authors declared no competing interests.

Source: Lin A et al. BMJ Open. 2021 Sep 21. doi: 10.1136/bmjopen-2021-052025.

Key clinical point: The risk of contracting COVID-19 among nonimmune family members decreases as the number of immune family members increases.

Major finding: An inverse dose-response association was seen between the number of immune members in each family and the risk for incident COVID-19 in nonimmune family members. Families with 1 immune member had a 45%-61% lower risk for COVID-19, whereas families with 4 immune members had a 97% lower risk.

Study details: The data come from an analysis of 1,789,728 individuals from 814,806 families, consisting of 2-5 members each.

Disclosures: Information on funding was not available. The authors declared no competing interests.

Source: Nordström P et al. JAMA Intern Med. 2021 Oct 11. doi: 10.1001/jamainternmed.2021.5814.

Key clinical point: The risk of contracting COVID-19 among nonimmune family members decreases as the number of immune family members increases.

Major finding: An inverse dose-response association was seen between the number of immune members in each family and the risk for incident COVID-19 in nonimmune family members. Families with 1 immune member had a 45%-61% lower risk for COVID-19, whereas families with 4 immune members had a 97% lower risk.

Study details: The data come from an analysis of 1,789,728 individuals from 814,806 families, consisting of 2-5 members each.

Disclosures: Information on funding was not available. The authors declared no competing interests.

Source: Nordström P et al. JAMA Intern Med. 2021 Oct 11. doi: 10.1001/jamainternmed.2021.5814.

Key clinical point: The risk of contracting COVID-19 among nonimmune family members decreases as the number of immune family members increases.

Major finding: An inverse dose-response association was seen between the number of immune members in each family and the risk for incident COVID-19 in nonimmune family members. Families with 1 immune member had a 45%-61% lower risk for COVID-19, whereas families with 4 immune members had a 97% lower risk.

Study details: The data come from an analysis of 1,789,728 individuals from 814,806 families, consisting of 2-5 members each.

Disclosures: Information on funding was not available. The authors declared no competing interests.

Source: Nordström P et al. JAMA Intern Med. 2021 Oct 11. doi: 10.1001/jamainternmed.2021.5814.

Key clinical point: In patients receiving high-flow nasal cannula (HFNC) for acute hypoxemic respiratory failure associated with COVID-19, initiating awake prone positioning (proning) soon after HFNC may improve survival.

Major finding: Initiating awake proning within 24 hours of HFNC was associated with lower mortality rates than late proning (26% vs 45%; P = .039).

Study details: The data come from a post hoc analysis of a trial evaluating awake proning in HFNC-treated patients with COVID-19 with respiratory failure (n=125).

Disclosures: The study was supported by the Rice Foundation. R Kaur, DL Vines, JD Scott, MW Trump, and J Li reported relationships with pharmaceutical/medical device companies and/or research organizations. The remaining authors declared no conflict of interests.

Source: Kaur R et al. Crit Care. 2021 Sep 17. doi: 10.1186/s13054-021-03761-9.

Key clinical point: In patients receiving high-flow nasal cannula (HFNC) for acute hypoxemic respiratory failure associated with COVID-19, initiating awake prone positioning (proning) soon after HFNC may improve survival.

Major finding: Initiating awake proning within 24 hours of HFNC was associated with lower mortality rates than late proning (26% vs 45%; P = .039).

Study details: The data come from a post hoc analysis of a trial evaluating awake proning in HFNC-treated patients with COVID-19 with respiratory failure (n=125).

Disclosures: The study was supported by the Rice Foundation. R Kaur, DL Vines, JD Scott, MW Trump, and J Li reported relationships with pharmaceutical/medical device companies and/or research organizations. The remaining authors declared no conflict of interests.

Source: Kaur R et al. Crit Care. 2021 Sep 17. doi: 10.1186/s13054-021-03761-9.

Key clinical point: In patients receiving high-flow nasal cannula (HFNC) for acute hypoxemic respiratory failure associated with COVID-19, initiating awake prone positioning (proning) soon after HFNC may improve survival.

Major finding: Initiating awake proning within 24 hours of HFNC was associated with lower mortality rates than late proning (26% vs 45%; P = .039).

Study details: The data come from a post hoc analysis of a trial evaluating awake proning in HFNC-treated patients with COVID-19 with respiratory failure (n=125).

Disclosures: The study was supported by the Rice Foundation. R Kaur, DL Vines, JD Scott, MW Trump, and J Li reported relationships with pharmaceutical/medical device companies and/or research organizations. The remaining authors declared no conflict of interests.

Source: Kaur R et al. Crit Care. 2021 Sep 17. doi: 10.1186/s13054-021-03761-9.

Key clinical point: Serum albumin levels at presentation may be a potential marker for COVID-19 severity and prognosis.

Major finding: Serum albumin of <3.5 g/dL was an independent risk factor for severe infection (adjusted odds ratio [aOR], 2.924; 95% confidence interval [CI], 1.509-5.664) and 30-day mortality (aOR, 2.615; 95% CI, 1.131-6.051).

Study details: A retrospective observational study included 296 patients with COVID-19 from emergency departments of 3 hospitals in Italy.

Disclosures: The study did not receive any funding. The authors declared no competing interests.

Source: Turcato G et al. Emerg Med J. 2021 Sep 21. doi: 10.1136/emermed-2020-210081.

Key clinical point: Serum albumin levels at presentation may be a potential marker for COVID-19 severity and prognosis.

Major finding: Serum albumin of <3.5 g/dL was an independent risk factor for severe infection (adjusted odds ratio [aOR], 2.924; 95% confidence interval [CI], 1.509-5.664) and 30-day mortality (aOR, 2.615; 95% CI, 1.131-6.051).

Study details: A retrospective observational study included 296 patients with COVID-19 from emergency departments of 3 hospitals in Italy.

Disclosures: The study did not receive any funding. The authors declared no competing interests.

Source: Turcato G et al. Emerg Med J. 2021 Sep 21. doi: 10.1136/emermed-2020-210081.

Key clinical point: Serum albumin levels at presentation may be a potential marker for COVID-19 severity and prognosis.

Major finding: Serum albumin of <3.5 g/dL was an independent risk factor for severe infection (adjusted odds ratio [aOR], 2.924; 95% confidence interval [CI], 1.509-5.664) and 30-day mortality (aOR, 2.615; 95% CI, 1.131-6.051).

Study details: A retrospective observational study included 296 patients with COVID-19 from emergency departments of 3 hospitals in Italy.

Disclosures: The study did not receive any funding. The authors declared no competing interests.

Source: Turcato G et al. Emerg Med J. 2021 Sep 21. doi: 10.1136/emermed-2020-210081.

Key clinical point: Critically ill patients with COVID-19 fail to benefit from convalescent plasma.

Major finding: The trial was stopped early after the probability of futility was calculated at 99.4%. Convalescent plasma vs. no plasma groups had 0 vs 3 organ support-free days, 37.3% vs 38.4% in-hospital mortality rates, and 14 vs 14 median days alive and free of organ support.

Study details: The data come from an open-label, randomized component of the ongoing REMAP-CAP trial (n=2,011). Critically ill adults with COVID-19 were randomly assigned to receive convalescent plasma or not.

Disclosures: The study was funded by nonprofits in multiple countries. Several authors reported relationships with pharmaceutical companies and/or research organizations.

Source: Estcourt LJ et al. JAMA. 2021 Oct 4. doi: 10.1001/jama.2021.18178.

Key clinical point: Critically ill patients with COVID-19 fail to benefit from convalescent plasma.

Major finding: The trial was stopped early after the probability of futility was calculated at 99.4%. Convalescent plasma vs. no plasma groups had 0 vs 3 organ support-free days, 37.3% vs 38.4% in-hospital mortality rates, and 14 vs 14 median days alive and free of organ support.

Study details: The data come from an open-label, randomized component of the ongoing REMAP-CAP trial (n=2,011). Critically ill adults with COVID-19 were randomly assigned to receive convalescent plasma or not.

Disclosures: The study was funded by nonprofits in multiple countries. Several authors reported relationships with pharmaceutical companies and/or research organizations.

Source: Estcourt LJ et al. JAMA. 2021 Oct 4. doi: 10.1001/jama.2021.18178.

Key clinical point: Critically ill patients with COVID-19 fail to benefit from convalescent plasma.

Major finding: The trial was stopped early after the probability of futility was calculated at 99.4%. Convalescent plasma vs. no plasma groups had 0 vs 3 organ support-free days, 37.3% vs 38.4% in-hospital mortality rates, and 14 vs 14 median days alive and free of organ support.

Study details: The data come from an open-label, randomized component of the ongoing REMAP-CAP trial (n=2,011). Critically ill adults with COVID-19 were randomly assigned to receive convalescent plasma or not.

Disclosures: The study was funded by nonprofits in multiple countries. Several authors reported relationships with pharmaceutical companies and/or research organizations.

Source: Estcourt LJ et al. JAMA. 2021 Oct 4. doi: 10.1001/jama.2021.18178.

Key clinical point: Pulmonary sequelae at 6 months after COVID-19 infection are more common in patients with diabetes or hyperglycemia compared with normoglycemic individuals.

Major finding: At 6 months, residual lung abnormalities on computed tomography were seen in 65.4%, 58.3%, and 36.6% of patients with preexisting diabetes, secondary hyperglycemia, and normoglycemia, respectively.

Study details: The data come from a retrospective study of 141 patients with COVID-19 at 2 hospitals in Wuhan, China.

Disclosures: The research was supported by the National Natural Science Foundation of China, National Key Research and Development Project of China, and Zhejiang University. The authors declared no competing interests.

Source: Li Y et al. Eur J Radiol. 2021 Oct 5. doi: 10.1016/j.ejrad.2021.109997.

Key clinical point: Pulmonary sequelae at 6 months after COVID-19 infection are more common in patients with diabetes or hyperglycemia compared with normoglycemic individuals.

Major finding: At 6 months, residual lung abnormalities on computed tomography were seen in 65.4%, 58.3%, and 36.6% of patients with preexisting diabetes, secondary hyperglycemia, and normoglycemia, respectively.

Study details: The data come from a retrospective study of 141 patients with COVID-19 at 2 hospitals in Wuhan, China.

Disclosures: The research was supported by the National Natural Science Foundation of China, National Key Research and Development Project of China, and Zhejiang University. The authors declared no competing interests.

Source: Li Y et al. Eur J Radiol. 2021 Oct 5. doi: 10.1016/j.ejrad.2021.109997.

Key clinical point: Pulmonary sequelae at 6 months after COVID-19 infection are more common in patients with diabetes or hyperglycemia compared with normoglycemic individuals.

Major finding: At 6 months, residual lung abnormalities on computed tomography were seen in 65.4%, 58.3%, and 36.6% of patients with preexisting diabetes, secondary hyperglycemia, and normoglycemia, respectively.

Study details: The data come from a retrospective study of 141 patients with COVID-19 at 2 hospitals in Wuhan, China.

Disclosures: The research was supported by the National Natural Science Foundation of China, National Key Research and Development Project of China, and Zhejiang University. The authors declared no competing interests.

Source: Li Y et al. Eur J Radiol. 2021 Oct 5. doi: 10.1016/j.ejrad.2021.109997.

Patients who are being treated with Janus kinase (JAK) inhibitors overall show a high immune response rate to COVID-19 vaccination, one that matches the rates seen in patients on other immunosuppressants, a new study has found.

The patients taking a JAK inhibitor who are most at risk of a diminished response may be those on upadacitinib (Rinvoq) and anyone 65 years or older, wrote Raphaèle Seror, MD, PhD, of Paris-Saclay (France) University and coauthors. The study was published in The Lancet Rheumatology.

To gauge the effectiveness of COVID-19 vaccines in this subset of immunosuppressed patients, the researchers analyzed 113 participants in the MAJIK-SFR Registry, a multicenter study of French patients with rheumatoid or psoriatic arthritis. The participants were treated at 13 centers throughout France; their mean age was 61.8 years (standard deviation, 12.5), and 72% were female. A total of 56 were taking baricitinib (Olumiant), 30 were taking tofacitinib (Xeljanz), and 27 were taking upadacitinib.

Serologic assessment was performed an average of 8.7 weeks (SD, 5.2) after the last dose of vaccine. The overall response rate – defined as the proportion of patients with detectable anti-spike antibodies per manufacturer’s cutoff values – was 88% (100 of 113). The nonresponse rate was higher with upadacitinib (7 of 27 patients, 26%) than with baricitinib (5 of 56, 9%) or tofacitinib (1 of 30, 3%). The only nonresponders who were not age 65 or older were four of the seven who received upadacitinib. The interval between the last vaccine dose and serologic assessment was somewhat longer in nonresponders (11.3 weeks) than in responders (8.3 weeks).

Earlier this year, the American College of Rheumatology recommended withholding JAK inhibitors for 1 week after each vaccine dose because of “concern related to the effects of this medication class on interferon signaling that may result in a diminished vaccine response Only two patients in the study had treatment with JAK inhibitors stopped before or after vaccination.

Questions about antibody levels remain difficult to answer

“This study does further confirm a big point,” said Alfred Kim, MD, PhD, of Washington University, St. Louis, in an interview. “Most people on any sort of immunosuppression, with rare exceptions, can mount responses to COVID-19 vaccination.”

“What level of response is going to be sufficient, of course, is not clear,” he added. “Even though most people generate responses, at the population level those responses seem lower than those in nonimmunosuppressed people. Particularly for those on upadacitinib, which is lower than patients on the other JAK inhibitors. Is that problematic? We don’t know yet.”

Dr. Kim, who was part of a separate, earlier study that assessed vaccine response in patients with chronic inflammatory disease who were being treated with immunosuppressive medications, noted that many of the questions patients are asking about their antibody levels cannot yet be answered.

“It’s kind of the Wild West of serologic testing out there right now,” he said. “Even though we’re recommending that people still don’t check their antibody levels because their results are largely inactionable, everyone is still getting them anyway. But each of these tests are slightly different, and the results and the interpretation are further clouded because of those slight performance differences between each platform.”

Dr. Kim highlighted the number of different tests as one of this study’s notable limitations: 11 different assays were used to determine patients’ immune responses. “The authors made the argument that these tests are FDA approved, and that’s true, but that doesn’t necessarily mean much. Approval does translate to technical reliability but not to comparisons between the tests.”

As for next steps, both the authors and Dr. Kim recognized the need for a prospective trial. “To do a vaccine effectiveness–type study and show clinical protection against either infection or hospitalization – those are going to take a while, simply because of the nature of how many people you need for each of these studies,” he said. “Time will tell whether or not the data that are being presented here will translate literally into protective outcomes downstream.”

The MAJIK Registry is supported by the French Rheumatology Society. The authors acknowledged numerous potential conflicts of interest, including receiving consulting fees, research support, and honoraria from various pharmaceutical companies.

Patients who are being treated with Janus kinase (JAK) inhibitors overall show a high immune response rate to COVID-19 vaccination, one that matches the rates seen in patients on other immunosuppressants, a new study has found.

The patients taking a JAK inhibitor who are most at risk of a diminished response may be those on upadacitinib (Rinvoq) and anyone 65 years or older, wrote Raphaèle Seror, MD, PhD, of Paris-Saclay (France) University and coauthors. The study was published in The Lancet Rheumatology.

To gauge the effectiveness of COVID-19 vaccines in this subset of immunosuppressed patients, the researchers analyzed 113 participants in the MAJIK-SFR Registry, a multicenter study of French patients with rheumatoid or psoriatic arthritis. The participants were treated at 13 centers throughout France; their mean age was 61.8 years (standard deviation, 12.5), and 72% were female. A total of 56 were taking baricitinib (Olumiant), 30 were taking tofacitinib (Xeljanz), and 27 were taking upadacitinib.

Serologic assessment was performed an average of 8.7 weeks (SD, 5.2) after the last dose of vaccine. The overall response rate – defined as the proportion of patients with detectable anti-spike antibodies per manufacturer’s cutoff values – was 88% (100 of 113). The nonresponse rate was higher with upadacitinib (7 of 27 patients, 26%) than with baricitinib (5 of 56, 9%) or tofacitinib (1 of 30, 3%). The only nonresponders who were not age 65 or older were four of the seven who received upadacitinib. The interval between the last vaccine dose and serologic assessment was somewhat longer in nonresponders (11.3 weeks) than in responders (8.3 weeks).

Earlier this year, the American College of Rheumatology recommended withholding JAK inhibitors for 1 week after each vaccine dose because of “concern related to the effects of this medication class on interferon signaling that may result in a diminished vaccine response Only two patients in the study had treatment with JAK inhibitors stopped before or after vaccination.

Questions about antibody levels remain difficult to answer

“This study does further confirm a big point,” said Alfred Kim, MD, PhD, of Washington University, St. Louis, in an interview. “Most people on any sort of immunosuppression, with rare exceptions, can mount responses to COVID-19 vaccination.”

“What level of response is going to be sufficient, of course, is not clear,” he added. “Even though most people generate responses, at the population level those responses seem lower than those in nonimmunosuppressed people. Particularly for those on upadacitinib, which is lower than patients on the other JAK inhibitors. Is that problematic? We don’t know yet.”

Dr. Kim, who was part of a separate, earlier study that assessed vaccine response in patients with chronic inflammatory disease who were being treated with immunosuppressive medications, noted that many of the questions patients are asking about their antibody levels cannot yet be answered.

“It’s kind of the Wild West of serologic testing out there right now,” he said. “Even though we’re recommending that people still don’t check their antibody levels because their results are largely inactionable, everyone is still getting them anyway. But each of these tests are slightly different, and the results and the interpretation are further clouded because of those slight performance differences between each platform.”

Dr. Kim highlighted the number of different tests as one of this study’s notable limitations: 11 different assays were used to determine patients’ immune responses. “The authors made the argument that these tests are FDA approved, and that’s true, but that doesn’t necessarily mean much. Approval does translate to technical reliability but not to comparisons between the tests.”

As for next steps, both the authors and Dr. Kim recognized the need for a prospective trial. “To do a vaccine effectiveness–type study and show clinical protection against either infection or hospitalization – those are going to take a while, simply because of the nature of how many people you need for each of these studies,” he said. “Time will tell whether or not the data that are being presented here will translate literally into protective outcomes downstream.”

The MAJIK Registry is supported by the French Rheumatology Society. The authors acknowledged numerous potential conflicts of interest, including receiving consulting fees, research support, and honoraria from various pharmaceutical companies.

Patients who are being treated with Janus kinase (JAK) inhibitors overall show a high immune response rate to COVID-19 vaccination, one that matches the rates seen in patients on other immunosuppressants, a new study has found.

The patients taking a JAK inhibitor who are most at risk of a diminished response may be those on upadacitinib (Rinvoq) and anyone 65 years or older, wrote Raphaèle Seror, MD, PhD, of Paris-Saclay (France) University and coauthors. The study was published in The Lancet Rheumatology.

To gauge the effectiveness of COVID-19 vaccines in this subset of immunosuppressed patients, the researchers analyzed 113 participants in the MAJIK-SFR Registry, a multicenter study of French patients with rheumatoid or psoriatic arthritis. The participants were treated at 13 centers throughout France; their mean age was 61.8 years (standard deviation, 12.5), and 72% were female. A total of 56 were taking baricitinib (Olumiant), 30 were taking tofacitinib (Xeljanz), and 27 were taking upadacitinib.

Serologic assessment was performed an average of 8.7 weeks (SD, 5.2) after the last dose of vaccine. The overall response rate – defined as the proportion of patients with detectable anti-spike antibodies per manufacturer’s cutoff values – was 88% (100 of 113). The nonresponse rate was higher with upadacitinib (7 of 27 patients, 26%) than with baricitinib (5 of 56, 9%) or tofacitinib (1 of 30, 3%). The only nonresponders who were not age 65 or older were four of the seven who received upadacitinib. The interval between the last vaccine dose and serologic assessment was somewhat longer in nonresponders (11.3 weeks) than in responders (8.3 weeks).

Earlier this year, the American College of Rheumatology recommended withholding JAK inhibitors for 1 week after each vaccine dose because of “concern related to the effects of this medication class on interferon signaling that may result in a diminished vaccine response Only two patients in the study had treatment with JAK inhibitors stopped before or after vaccination.

Questions about antibody levels remain difficult to answer

“This study does further confirm a big point,” said Alfred Kim, MD, PhD, of Washington University, St. Louis, in an interview. “Most people on any sort of immunosuppression, with rare exceptions, can mount responses to COVID-19 vaccination.”

“What level of response is going to be sufficient, of course, is not clear,” he added. “Even though most people generate responses, at the population level those responses seem lower than those in nonimmunosuppressed people. Particularly for those on upadacitinib, which is lower than patients on the other JAK inhibitors. Is that problematic? We don’t know yet.”

Dr. Kim, who was part of a separate, earlier study that assessed vaccine response in patients with chronic inflammatory disease who were being treated with immunosuppressive medications, noted that many of the questions patients are asking about their antibody levels cannot yet be answered.

“It’s kind of the Wild West of serologic testing out there right now,” he said. “Even though we’re recommending that people still don’t check their antibody levels because their results are largely inactionable, everyone is still getting them anyway. But each of these tests are slightly different, and the results and the interpretation are further clouded because of those slight performance differences between each platform.”

Dr. Kim highlighted the number of different tests as one of this study’s notable limitations: 11 different assays were used to determine patients’ immune responses. “The authors made the argument that these tests are FDA approved, and that’s true, but that doesn’t necessarily mean much. Approval does translate to technical reliability but not to comparisons between the tests.”

As for next steps, both the authors and Dr. Kim recognized the need for a prospective trial. “To do a vaccine effectiveness–type study and show clinical protection against either infection or hospitalization – those are going to take a while, simply because of the nature of how many people you need for each of these studies,” he said. “Time will tell whether or not the data that are being presented here will translate literally into protective outcomes downstream.”

The MAJIK Registry is supported by the French Rheumatology Society. The authors acknowledged numerous potential conflicts of interest, including receiving consulting fees, research support, and honoraria from various pharmaceutical companies.

Individuals with substance use disorders (SUDs) have a twofold increased risk for COVID-related hospitalization and death even after vaccination, new research shows.

Investigators analyzed data on over 10,000 vaccinated individuals with various SUDs and almost 600,000 vaccinated individuals without an SUD. They found about twice as many individuals with an SUD had a breakthrough COVID-19 infection as their counterparts without an SUD, at 7% versus 3.6%, respectively.

Worrisome phase

SUDs are “often associated with multiple comorbid conditions that are known risk factors for severe outcome of COVID-19 infection,” the investigators note.

Research published early in the pandemic showed patients with SUDs, including alcohol, cannabis, cocaine, opioid, and tobacco use disorders, were “at increased risk for COVID-19 infection and associated severe outcomes, especially among African Americans,” they add.

To date, no research has focused on the potential risk for COVID in individuals with SUDs following vaccination. In addition, although vaccines are “very effective,” breakthrough infections have been recorded, “highlighting the need to identify populations that might be most vulnerable, as we have entered a worrisome new phase of the pandemic,” the authors write.

For the study, researchers used a data analytics platform that included de-identified information from 63 health care organizations across the U.S. to estimate the risk for breakthrough COVID-19 among vaccinated patients with SUD (n = 30,183; mean age 59.3, 51.4% male, 63.2% White, 26.2% African American), compared with vaccinated individuals without SUDs (n = 549,189; mean age 54.7, 43.2% male, 63.4% White, 14.3% African American) between December 2020 and August 2021.

They also conducted statistical analyses to examine how the rate of breakthrough cases changed over that timeframe.

The cohorts were matched by demographics, adverse socioeconomic determinants of health, lifetime medical and psychiatric comorbidities, and vaccine type.

Among vaccinated SUD patients, three-quarters received the Pfizer-BioNTech vaccine, one-fifth received the Moderna vaccine, and 3.3% received the Johnson & Johnson vaccine.

In contrast, among the vaccinated non-SUD population, almost all (88.2%) received the Pfizer-BioNTech vaccine, 10% received Moderna, and only 1.2% received the Johnson & Johnson vaccine.
 

Underlying drivers

The prevalence of adverse socioeconomic determinants of health was higher in vaccinated individuals with SUDs compared to those without (7.9% vs. 1.2%, respectively). Moreover, vaccinated patients with SUD had a higher lifetime prevalence of all comorbidities as well as transplants (all Ps < .001).

The risk for breakthrough infection was significantly higher in vaccinated individuals with SUDs compared to those without (all Ps < .001).

After controlling for adverse socioeconomic determinants of health and comorbid medical conditions, the risk for breakthrough infection “no longer differed in SUD compared to non-SUD cohorts, except for patients with cannabis use disorder, who remained at significantly increased risk,” the authors report.

In both populations, the rate of breakthrough infections “steadily increased” between January and August 2021.

The risk for hospitalization and death was higher among those with breakthrough infections, compared with those in the matched cohort without breakthrough infections, but the risk for hospitalization and death were higher in the SUD compared with the non-SUD population.

In the SUD patients, after matching an array of demographic, socioeconomic, and medical factors as well as vaccine type, only cannabis use disorder was associated with a higher risk in African Americans, compared with matched Caucasians (HR = 1.63; 95% confidence interval, 1.06-2.51).

“When we adjusted the data to account for comorbidities and for socioeconomic background, we no longer saw a difference between those with substance use disorders and those without – the only exception to this was for people with cannabis use disorder,” said Dr. Volkow.

“This suggests that these factors, which are often associated with substance use disorders, are likely the underlying drivers for the increased risk,” she continued.

She added that it is important for other studies to investigate why individuals with cannabis use disorder had a higher risk for breakthrough infections.
 

Good news, bad news

Commenting for this news organization, Anna Lembke, MD, professor of psychiatry and behavioral sciences, Stanford (Calif.) University, said the study is important and contains good news and bad news.

The good news, she said, “is that, after controlling for comorbidities and socioeconomic variables, patients with SUDs are no more likely than patients without SUDs to get COVID after getting vaccinated, and the bad news is that if vaccinated patients with SUDs do get COVID, they’re more likely to end up hospitalized or die from it,” said Dr. Lembke, who was not involved with the study.

“The take-home message for clinicians is that if your vaccinated patient with an SUD gets COVID, be on the alert for a more complicated medical outcome and a higher risk of death,” warned Dr. Lembke.

This study was supported by the U.S. National Institute on Drug Abuse, the U.S. National Institute of Aging, and the Clinical and Translational Science Collaborative (CTSC) of Cleveland. No disclosures were listed on the original study. Dr. Lembke has disclosed no relevant financial relationships.

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

Individuals with substance use disorders (SUDs) have a twofold increased risk for COVID-related hospitalization and death even after vaccination, new research shows.

Investigators analyzed data on over 10,000 vaccinated individuals with various SUDs and almost 600,000 vaccinated individuals without an SUD. They found about twice as many individuals with an SUD had a breakthrough COVID-19 infection as their counterparts without an SUD, at 7% versus 3.6%, respectively.

Worrisome phase

SUDs are “often associated with multiple comorbid conditions that are known risk factors for severe outcome of COVID-19 infection,” the investigators note.

Research published early in the pandemic showed patients with SUDs, including alcohol, cannabis, cocaine, opioid, and tobacco use disorders, were “at increased risk for COVID-19 infection and associated severe outcomes, especially among African Americans,” they add.

To date, no research has focused on the potential risk for COVID in individuals with SUDs following vaccination. In addition, although vaccines are “very effective,” breakthrough infections have been recorded, “highlighting the need to identify populations that might be most vulnerable, as we have entered a worrisome new phase of the pandemic,” the authors write.

For the study, researchers used a data analytics platform that included de-identified information from 63 health care organizations across the U.S. to estimate the risk for breakthrough COVID-19 among vaccinated patients with SUD (n = 30,183; mean age 59.3, 51.4% male, 63.2% White, 26.2% African American), compared with vaccinated individuals without SUDs (n = 549,189; mean age 54.7, 43.2% male, 63.4% White, 14.3% African American) between December 2020 and August 2021.

They also conducted statistical analyses to examine how the rate of breakthrough cases changed over that timeframe.

The cohorts were matched by demographics, adverse socioeconomic determinants of health, lifetime medical and psychiatric comorbidities, and vaccine type.

Among vaccinated SUD patients, three-quarters received the Pfizer-BioNTech vaccine, one-fifth received the Moderna vaccine, and 3.3% received the Johnson & Johnson vaccine.

In contrast, among the vaccinated non-SUD population, almost all (88.2%) received the Pfizer-BioNTech vaccine, 10% received Moderna, and only 1.2% received the Johnson & Johnson vaccine.
 

Underlying drivers

The prevalence of adverse socioeconomic determinants of health was higher in vaccinated individuals with SUDs compared to those without (7.9% vs. 1.2%, respectively). Moreover, vaccinated patients with SUD had a higher lifetime prevalence of all comorbidities as well as transplants (all Ps < .001).

The risk for breakthrough infection was significantly higher in vaccinated individuals with SUDs compared to those without (all Ps < .001).

After controlling for adverse socioeconomic determinants of health and comorbid medical conditions, the risk for breakthrough infection “no longer differed in SUD compared to non-SUD cohorts, except for patients with cannabis use disorder, who remained at significantly increased risk,” the authors report.

In both populations, the rate of breakthrough infections “steadily increased” between January and August 2021.

The risk for hospitalization and death was higher among those with breakthrough infections, compared with those in the matched cohort without breakthrough infections, but the risk for hospitalization and death were higher in the SUD compared with the non-SUD population.

In the SUD patients, after matching an array of demographic, socioeconomic, and medical factors as well as vaccine type, only cannabis use disorder was associated with a higher risk in African Americans, compared with matched Caucasians (HR = 1.63; 95% confidence interval, 1.06-2.51).

“When we adjusted the data to account for comorbidities and for socioeconomic background, we no longer saw a difference between those with substance use disorders and those without – the only exception to this was for people with cannabis use disorder,” said Dr. Volkow.

“This suggests that these factors, which are often associated with substance use disorders, are likely the underlying drivers for the increased risk,” she continued.

She added that it is important for other studies to investigate why individuals with cannabis use disorder had a higher risk for breakthrough infections.
 

Good news, bad news

Commenting for this news organization, Anna Lembke, MD, professor of psychiatry and behavioral sciences, Stanford (Calif.) University, said the study is important and contains good news and bad news.

The good news, she said, “is that, after controlling for comorbidities and socioeconomic variables, patients with SUDs are no more likely than patients without SUDs to get COVID after getting vaccinated, and the bad news is that if vaccinated patients with SUDs do get COVID, they’re more likely to end up hospitalized or die from it,” said Dr. Lembke, who was not involved with the study.

“The take-home message for clinicians is that if your vaccinated patient with an SUD gets COVID, be on the alert for a more complicated medical outcome and a higher risk of death,” warned Dr. Lembke.

This study was supported by the U.S. National Institute on Drug Abuse, the U.S. National Institute of Aging, and the Clinical and Translational Science Collaborative (CTSC) of Cleveland. No disclosures were listed on the original study. Dr. Lembke has disclosed no relevant financial relationships.

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

Individuals with substance use disorders (SUDs) have a twofold increased risk for COVID-related hospitalization and death even after vaccination, new research shows.

Investigators analyzed data on over 10,000 vaccinated individuals with various SUDs and almost 600,000 vaccinated individuals without an SUD. They found about twice as many individuals with an SUD had a breakthrough COVID-19 infection as their counterparts without an SUD, at 7% versus 3.6%, respectively.

Worrisome phase

SUDs are “often associated with multiple comorbid conditions that are known risk factors for severe outcome of COVID-19 infection,” the investigators note.

Research published early in the pandemic showed patients with SUDs, including alcohol, cannabis, cocaine, opioid, and tobacco use disorders, were “at increased risk for COVID-19 infection and associated severe outcomes, especially among African Americans,” they add.

To date, no research has focused on the potential risk for COVID in individuals with SUDs following vaccination. In addition, although vaccines are “very effective,” breakthrough infections have been recorded, “highlighting the need to identify populations that might be most vulnerable, as we have entered a worrisome new phase of the pandemic,” the authors write.

For the study, researchers used a data analytics platform that included de-identified information from 63 health care organizations across the U.S. to estimate the risk for breakthrough COVID-19 among vaccinated patients with SUD (n = 30,183; mean age 59.3, 51.4% male, 63.2% White, 26.2% African American), compared with vaccinated individuals without SUDs (n = 549,189; mean age 54.7, 43.2% male, 63.4% White, 14.3% African American) between December 2020 and August 2021.

They also conducted statistical analyses to examine how the rate of breakthrough cases changed over that timeframe.

The cohorts were matched by demographics, adverse socioeconomic determinants of health, lifetime medical and psychiatric comorbidities, and vaccine type.

Among vaccinated SUD patients, three-quarters received the Pfizer-BioNTech vaccine, one-fifth received the Moderna vaccine, and 3.3% received the Johnson & Johnson vaccine.

In contrast, among the vaccinated non-SUD population, almost all (88.2%) received the Pfizer-BioNTech vaccine, 10% received Moderna, and only 1.2% received the Johnson & Johnson vaccine.
 

Underlying drivers

The prevalence of adverse socioeconomic determinants of health was higher in vaccinated individuals with SUDs compared to those without (7.9% vs. 1.2%, respectively). Moreover, vaccinated patients with SUD had a higher lifetime prevalence of all comorbidities as well as transplants (all Ps < .001).

The risk for breakthrough infection was significantly higher in vaccinated individuals with SUDs compared to those without (all Ps < .001).

After controlling for adverse socioeconomic determinants of health and comorbid medical conditions, the risk for breakthrough infection “no longer differed in SUD compared to non-SUD cohorts, except for patients with cannabis use disorder, who remained at significantly increased risk,” the authors report.

In both populations, the rate of breakthrough infections “steadily increased” between January and August 2021.

The risk for hospitalization and death was higher among those with breakthrough infections, compared with those in the matched cohort without breakthrough infections, but the risk for hospitalization and death were higher in the SUD compared with the non-SUD population.

In the SUD patients, after matching an array of demographic, socioeconomic, and medical factors as well as vaccine type, only cannabis use disorder was associated with a higher risk in African Americans, compared with matched Caucasians (HR = 1.63; 95% confidence interval, 1.06-2.51).

“When we adjusted the data to account for comorbidities and for socioeconomic background, we no longer saw a difference between those with substance use disorders and those without – the only exception to this was for people with cannabis use disorder,” said Dr. Volkow.

“This suggests that these factors, which are often associated with substance use disorders, are likely the underlying drivers for the increased risk,” she continued.

She added that it is important for other studies to investigate why individuals with cannabis use disorder had a higher risk for breakthrough infections.
 

Good news, bad news

Commenting for this news organization, Anna Lembke, MD, professor of psychiatry and behavioral sciences, Stanford (Calif.) University, said the study is important and contains good news and bad news.

The good news, she said, “is that, after controlling for comorbidities and socioeconomic variables, patients with SUDs are no more likely than patients without SUDs to get COVID after getting vaccinated, and the bad news is that if vaccinated patients with SUDs do get COVID, they’re more likely to end up hospitalized or die from it,” said Dr. Lembke, who was not involved with the study.

“The take-home message for clinicians is that if your vaccinated patient with an SUD gets COVID, be on the alert for a more complicated medical outcome and a higher risk of death,” warned Dr. Lembke.

This study was supported by the U.S. National Institute on Drug Abuse, the U.S. National Institute of Aging, and the Clinical and Translational Science Collaborative (CTSC) of Cleveland. No disclosures were listed on the original study. Dr. Lembke has disclosed no relevant financial relationships.

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

Marconi et al report out the results of the COV-Barrier study, a phase 3 randomized placebo controlled (RCT) trial with baricitinib, a JAK-STAT pathway inhibitor generally used to suppress proinflammatory cytokine production and systemic inflammation in rheumatoid arthritis, in hospitalized COVID-19 patients. The 1525 participants equally divided between placebo and baricitinib in an intention to treat analysis, were recruited from 12 countries, and most were on systemic corticosteroids (79.3%) and about one fifth received the antiviral, remdesivir. The study did not show a difference in the primary outcome (a composite of progression to more severe disease including need for high flow oxygen, non-invasive or invasive mechanical ventilation or death by 28 days), but did note a 5% absolute reduction in mortality at 28 days. Based on this results, Baricitinib may have a role similar role in the care of COVID-19 patients as tocilizumab (an IL-6 inhibitor) when given in combination with steroids, but may be used in the care of patients earlier in their disease including those on high flow or noninvasive oxygen as well as those requiring invasive mechanical ventilation, compared to tocilizumab, which is currently preferred by many clinicians in those on more intensive respiratory support and within 24-48 hours of ICU admission.  Like other immunomodulators, there is a concern for increased secondary infections with the use of this therapy, but JAK inhibitors also carry a risk for increase in venous thromboembolic events. Interestingly, in this trial, there was no difference in the incidence of either of these adverse effects between the placebo and treatment groups.

The results of a phase 3 RCT with Canakinumab, an anti-interleukin-1B monoclonal antibody, on the other hand, did not show a benefit in primary outcome of survival without need for mechanical ventilation day 3 to day 29, or recovery time, in hospitalized patients who had elevated C-reactive protein and ferritin but were not yet intubated. Canakinumab was evaluated because IL-1B has been identified as one of the signature elevated cytokines in a maladaptive immune response to SARS-CoV-2 infection and because had shown some promise in small and retrospective studies. 

Lastly, on the prevention side, a study of Regeneron’s anti-SARS-CoV-2 monoclonal antibody cocktail (casirivimab and imdevimab) was evaluated in a double blind placebo controlled RCT in prevention of development of symptomatic SARS-CoV-2 infection within 28 days among household contacts who did not have prior immunity. In the study, 1.5% of those who received the monoclonal therapy subcutaneously versus 7.8% of those who received placebo met the primary endpoint. Additionally, those who received the therapy and were symptomatic, resolved their symptoms two weeks earlier. The real-world utility of the results, however, maybe limited to specific groups, given that need for early identification of contacts, the need to access medical facility for administration, as well as the cost of the drug. There may be a role in high risk and immunocompromised contacts who do not develop adequate immune response to vaccination.

Marconi et al report out the results of the COV-Barrier study, a phase 3 randomized placebo controlled (RCT) trial with baricitinib, a JAK-STAT pathway inhibitor generally used to suppress proinflammatory cytokine production and systemic inflammation in rheumatoid arthritis, in hospitalized COVID-19 patients. The 1525 participants equally divided between placebo and baricitinib in an intention to treat analysis, were recruited from 12 countries, and most were on systemic corticosteroids (79.3%) and about one fifth received the antiviral, remdesivir. The study did not show a difference in the primary outcome (a composite of progression to more severe disease including need for high flow oxygen, non-invasive or invasive mechanical ventilation or death by 28 days), but did note a 5% absolute reduction in mortality at 28 days. Based on this results, Baricitinib may have a role similar role in the care of COVID-19 patients as tocilizumab (an IL-6 inhibitor) when given in combination with steroids, but may be used in the care of patients earlier in their disease including those on high flow or noninvasive oxygen as well as those requiring invasive mechanical ventilation, compared to tocilizumab, which is currently preferred by many clinicians in those on more intensive respiratory support and within 24-48 hours of ICU admission.  Like other immunomodulators, there is a concern for increased secondary infections with the use of this therapy, but JAK inhibitors also carry a risk for increase in venous thromboembolic events. Interestingly, in this trial, there was no difference in the incidence of either of these adverse effects between the placebo and treatment groups.

The results of a phase 3 RCT with Canakinumab, an anti-interleukin-1B monoclonal antibody, on the other hand, did not show a benefit in primary outcome of survival without need for mechanical ventilation day 3 to day 29, or recovery time, in hospitalized patients who had elevated C-reactive protein and ferritin but were not yet intubated. Canakinumab was evaluated because IL-1B has been identified as one of the signature elevated cytokines in a maladaptive immune response to SARS-CoV-2 infection and because had shown some promise in small and retrospective studies. 

Lastly, on the prevention side, a study of Regeneron’s anti-SARS-CoV-2 monoclonal antibody cocktail (casirivimab and imdevimab) was evaluated in a double blind placebo controlled RCT in prevention of development of symptomatic SARS-CoV-2 infection within 28 days among household contacts who did not have prior immunity. In the study, 1.5% of those who received the monoclonal therapy subcutaneously versus 7.8% of those who received placebo met the primary endpoint. Additionally, those who received the therapy and were symptomatic, resolved their symptoms two weeks earlier. The real-world utility of the results, however, maybe limited to specific groups, given that need for early identification of contacts, the need to access medical facility for administration, as well as the cost of the drug. There may be a role in high risk and immunocompromised contacts who do not develop adequate immune response to vaccination.

Marconi et al report out the results of the COV-Barrier study, a phase 3 randomized placebo controlled (RCT) trial with baricitinib, a JAK-STAT pathway inhibitor generally used to suppress proinflammatory cytokine production and systemic inflammation in rheumatoid arthritis, in hospitalized COVID-19 patients. The 1525 participants equally divided between placebo and baricitinib in an intention to treat analysis, were recruited from 12 countries, and most were on systemic corticosteroids (79.3%) and about one fifth received the antiviral, remdesivir. The study did not show a difference in the primary outcome (a composite of progression to more severe disease including need for high flow oxygen, non-invasive or invasive mechanical ventilation or death by 28 days), but did note a 5% absolute reduction in mortality at 28 days. Based on this results, Baricitinib may have a role similar role in the care of COVID-19 patients as tocilizumab (an IL-6 inhibitor) when given in combination with steroids, but may be used in the care of patients earlier in their disease including those on high flow or noninvasive oxygen as well as those requiring invasive mechanical ventilation, compared to tocilizumab, which is currently preferred by many clinicians in those on more intensive respiratory support and within 24-48 hours of ICU admission.  Like other immunomodulators, there is a concern for increased secondary infections with the use of this therapy, but JAK inhibitors also carry a risk for increase in venous thromboembolic events. Interestingly, in this trial, there was no difference in the incidence of either of these adverse effects between the placebo and treatment groups.

The results of a phase 3 RCT with Canakinumab, an anti-interleukin-1B monoclonal antibody, on the other hand, did not show a benefit in primary outcome of survival without need for mechanical ventilation day 3 to day 29, or recovery time, in hospitalized patients who had elevated C-reactive protein and ferritin but were not yet intubated. Canakinumab was evaluated because IL-1B has been identified as one of the signature elevated cytokines in a maladaptive immune response to SARS-CoV-2 infection and because had shown some promise in small and retrospective studies. 

Lastly, on the prevention side, a study of Regeneron’s anti-SARS-CoV-2 monoclonal antibody cocktail (casirivimab and imdevimab) was evaluated in a double blind placebo controlled RCT in prevention of development of symptomatic SARS-CoV-2 infection within 28 days among household contacts who did not have prior immunity. In the study, 1.5% of those who received the monoclonal therapy subcutaneously versus 7.8% of those who received placebo met the primary endpoint. Additionally, those who received the therapy and were symptomatic, resolved their symptoms two weeks earlier. The real-world utility of the results, however, maybe limited to specific groups, given that need for early identification of contacts, the need to access medical facility for administration, as well as the cost of the drug. There may be a role in high risk and immunocompromised contacts who do not develop adequate immune response to vaccination.

Key clinical point: A meta-analysis has identified 10 key risk factors for mortality in hospitalized patients with COVID-19.

Major finding: The significant mortality-related risk factors in hospitalized patients with COVID-19 included older age, male sex, smoking, obesity, cardiovascular disease, diabetes, hypertension, chronic obstructive pulmonary disease, acute kidney injury, and elevated D-dimer levels.

Study details: The data come from a meta-analysis of 42 studies involving 423,117 patients with COVID-19.

Disclosures: The study did not receive any funding. The authors declared no conflict of interests.

Source: Dessie ZG et al. BMC Infect Dis. 2021 Aug 21. doi: 10.1186/s12879-021-06536-3.

Key clinical point: A meta-analysis has identified 10 key risk factors for mortality in hospitalized patients with COVID-19.

Major finding: The significant mortality-related risk factors in hospitalized patients with COVID-19 included older age, male sex, smoking, obesity, cardiovascular disease, diabetes, hypertension, chronic obstructive pulmonary disease, acute kidney injury, and elevated D-dimer levels.

Study details: The data come from a meta-analysis of 42 studies involving 423,117 patients with COVID-19.

Disclosures: The study did not receive any funding. The authors declared no conflict of interests.

Source: Dessie ZG et al. BMC Infect Dis. 2021 Aug 21. doi: 10.1186/s12879-021-06536-3.

Key clinical point: A meta-analysis has identified 10 key risk factors for mortality in hospitalized patients with COVID-19.

Major finding: The significant mortality-related risk factors in hospitalized patients with COVID-19 included older age, male sex, smoking, obesity, cardiovascular disease, diabetes, hypertension, chronic obstructive pulmonary disease, acute kidney injury, and elevated D-dimer levels.

Study details: The data come from a meta-analysis of 42 studies involving 423,117 patients with COVID-19.

Disclosures: The study did not receive any funding. The authors declared no conflict of interests.

Source: Dessie ZG et al. BMC Infect Dis. 2021 Aug 21. doi: 10.1186/s12879-021-06536-3.