In past posts for this news organization, I’ve railed against the cost of inappropriate prescriptions for oxygen. A recent review recommended against prescribing oxygen for patients with isolated exertional or nocturnal desaturations, and recently published randomized trials found no demonstrable benefit to oxygen use in the absence of resting hypoxemia. My oxygen ire was previously directed at inappropriate screening for nocturnal or exertional hypoxemia in outpatients with chronic obstructive pulmonary disorder (COPD), a common practice in clinics where I’ve worked. However, oxygen prescriptions at hospital discharge are a far more pernicious cause of wasted resources.

Prescriptions at hospital discharge, sometimes referred to as short-term oxygen therapy (STOT), account for a large proportion of total oxygen use. Past data have shown that the term “STOT” is a misnomer, as most patients provided with oxygen at discharge are never reevaluated and become long-term oxygen users. The high cost of durable medical equipment related to oxygen delivery prompted the American Thoracic Society and American College of Chest Physicians to recommend postdischarge reassessment of oxygen needs in their Choosing Wisely campaign for adult pulmonary medicine.

A recent study published in the Annals of the American Thoracic Society (Ann ATS) highlights the benefits available if we decide to “choose wisely.” The authors studied patients covered by Veterans Affairs and discharged on STOT between 2006 and 2011. Only 43.6% (287/659) had complete reassessment (oxygen testing at rest and with ambulation) within 90 days. Of those, 124 (43.2%) were eligible for discontinuation via Centers for Medicare & Medicaid Services guidelines. A total of 70.7% (466/659) were tested at rest, and only 15.7% (73/466) had resting hypoxemia. If one accepts the results of the recently published Long-Term Oxygen Treatment Trial, this means that 84.3% (393/466) would be eligible for oxygen discontinuation.

The Ann ATS study provides a blueprint for how we might improve these dismal numbers. There were five separate sites reviewed in their paper. At one site, reassessment occurred in 78.5% of STOT patients and 100% had oxygen discontinued when appropriate. What was their secret? An automatic alert system and a dedicated clinic, coordinator, and respiratory therapist. Also, among the 124 patients who had a full reassessment and no longer qualified for oxygen, 86.3% had it discontinued.

There are countless reasons why STOT is common, but discontinuation is not. Most COPD exacerbations are managed by nonpulmonologists on general medicine wards prior to discharge. In my experience, these physicians are reluctant to release a patient with exertional hypoxia without STOT. They also assume that the pulmonary clinic will do its job during the obligatory outpatient follow-up appointment they schedule with us. At the follow-up, the patient and physician are reluctant to stop therapy because of psychological dependence and therapeutic overconfidence, respectively.

In summary, STOT following hospitalization comprises the majority of all oxygen prescriptions. Historically, the United States provides far more oxygen than other developed countries, and only CMS reimbursement changes have bent the “overprescription” curve. The Ann ATS study shows that a well-designed program at the hospital level can put oxygen decisions back in the hands of providers.

Let’s “choose wisely” and follow what works, or we’ll have only ourselves to blame when reimbursement decisions are taken out of our hands.

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

In past posts for this news organization, I’ve railed against the cost of inappropriate prescriptions for oxygen. A recent review recommended against prescribing oxygen for patients with isolated exertional or nocturnal desaturations, and recently published randomized trials found no demonstrable benefit to oxygen use in the absence of resting hypoxemia. My oxygen ire was previously directed at inappropriate screening for nocturnal or exertional hypoxemia in outpatients with chronic obstructive pulmonary disorder (COPD), a common practice in clinics where I’ve worked. However, oxygen prescriptions at hospital discharge are a far more pernicious cause of wasted resources.

Prescriptions at hospital discharge, sometimes referred to as short-term oxygen therapy (STOT), account for a large proportion of total oxygen use. Past data have shown that the term “STOT” is a misnomer, as most patients provided with oxygen at discharge are never reevaluated and become long-term oxygen users. The high cost of durable medical equipment related to oxygen delivery prompted the American Thoracic Society and American College of Chest Physicians to recommend postdischarge reassessment of oxygen needs in their Choosing Wisely campaign for adult pulmonary medicine.

A recent study published in the Annals of the American Thoracic Society (Ann ATS) highlights the benefits available if we decide to “choose wisely.” The authors studied patients covered by Veterans Affairs and discharged on STOT between 2006 and 2011. Only 43.6% (287/659) had complete reassessment (oxygen testing at rest and with ambulation) within 90 days. Of those, 124 (43.2%) were eligible for discontinuation via Centers for Medicare & Medicaid Services guidelines. A total of 70.7% (466/659) were tested at rest, and only 15.7% (73/466) had resting hypoxemia. If one accepts the results of the recently published Long-Term Oxygen Treatment Trial, this means that 84.3% (393/466) would be eligible for oxygen discontinuation.

The Ann ATS study provides a blueprint for how we might improve these dismal numbers. There were five separate sites reviewed in their paper. At one site, reassessment occurred in 78.5% of STOT patients and 100% had oxygen discontinued when appropriate. What was their secret? An automatic alert system and a dedicated clinic, coordinator, and respiratory therapist. Also, among the 124 patients who had a full reassessment and no longer qualified for oxygen, 86.3% had it discontinued.

There are countless reasons why STOT is common, but discontinuation is not. Most COPD exacerbations are managed by nonpulmonologists on general medicine wards prior to discharge. In my experience, these physicians are reluctant to release a patient with exertional hypoxia without STOT. They also assume that the pulmonary clinic will do its job during the obligatory outpatient follow-up appointment they schedule with us. At the follow-up, the patient and physician are reluctant to stop therapy because of psychological dependence and therapeutic overconfidence, respectively.

In summary, STOT following hospitalization comprises the majority of all oxygen prescriptions. Historically, the United States provides far more oxygen than other developed countries, and only CMS reimbursement changes have bent the “overprescription” curve. The Ann ATS study shows that a well-designed program at the hospital level can put oxygen decisions back in the hands of providers.

Let’s “choose wisely” and follow what works, or we’ll have only ourselves to blame when reimbursement decisions are taken out of our hands.

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

In past posts for this news organization, I’ve railed against the cost of inappropriate prescriptions for oxygen. A recent review recommended against prescribing oxygen for patients with isolated exertional or nocturnal desaturations, and recently published randomized trials found no demonstrable benefit to oxygen use in the absence of resting hypoxemia. My oxygen ire was previously directed at inappropriate screening for nocturnal or exertional hypoxemia in outpatients with chronic obstructive pulmonary disorder (COPD), a common practice in clinics where I’ve worked. However, oxygen prescriptions at hospital discharge are a far more pernicious cause of wasted resources.

Prescriptions at hospital discharge, sometimes referred to as short-term oxygen therapy (STOT), account for a large proportion of total oxygen use. Past data have shown that the term “STOT” is a misnomer, as most patients provided with oxygen at discharge are never reevaluated and become long-term oxygen users. The high cost of durable medical equipment related to oxygen delivery prompted the American Thoracic Society and American College of Chest Physicians to recommend postdischarge reassessment of oxygen needs in their Choosing Wisely campaign for adult pulmonary medicine.

A recent study published in the Annals of the American Thoracic Society (Ann ATS) highlights the benefits available if we decide to “choose wisely.” The authors studied patients covered by Veterans Affairs and discharged on STOT between 2006 and 2011. Only 43.6% (287/659) had complete reassessment (oxygen testing at rest and with ambulation) within 90 days. Of those, 124 (43.2%) were eligible for discontinuation via Centers for Medicare & Medicaid Services guidelines. A total of 70.7% (466/659) were tested at rest, and only 15.7% (73/466) had resting hypoxemia. If one accepts the results of the recently published Long-Term Oxygen Treatment Trial, this means that 84.3% (393/466) would be eligible for oxygen discontinuation.

The Ann ATS study provides a blueprint for how we might improve these dismal numbers. There were five separate sites reviewed in their paper. At one site, reassessment occurred in 78.5% of STOT patients and 100% had oxygen discontinued when appropriate. What was their secret? An automatic alert system and a dedicated clinic, coordinator, and respiratory therapist. Also, among the 124 patients who had a full reassessment and no longer qualified for oxygen, 86.3% had it discontinued.

There are countless reasons why STOT is common, but discontinuation is not. Most COPD exacerbations are managed by nonpulmonologists on general medicine wards prior to discharge. In my experience, these physicians are reluctant to release a patient with exertional hypoxia without STOT. They also assume that the pulmonary clinic will do its job during the obligatory outpatient follow-up appointment they schedule with us. At the follow-up, the patient and physician are reluctant to stop therapy because of psychological dependence and therapeutic overconfidence, respectively.

In summary, STOT following hospitalization comprises the majority of all oxygen prescriptions. Historically, the United States provides far more oxygen than other developed countries, and only CMS reimbursement changes have bent the “overprescription” curve. The Ann ATS study shows that a well-designed program at the hospital level can put oxygen decisions back in the hands of providers.

Let’s “choose wisely” and follow what works, or we’ll have only ourselves to blame when reimbursement decisions are taken out of our hands.

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

People with psoriasis have a higher risk of infection with COVID-19 than the general population, but some systemic treatments appear to lower risk in patients, compared with those on topical therapy, a new study finds.

“Our study results suggest that psoriasis is an independent risk factor for COVID-19 illness,” study coauthor Jeffrey Liu, a medical student at the University of Southern California, Los Angeles, said in an interview after he presented the findings at the American Academy of Dermatology Virtual Meeting Experience. “And our findings are consistent with the hypothesis that certain systemic agents may confer a protective effect against COVID-19 illness.”

Mr. Liu and coinvestigators used a Symphony Health dataset to analyze the health records of 167,027 U.S. patients diagnosed with psoriasis and a control group of 1,002,162 patients. The participants, all at least 20 years old, had been treated for psoriasis or psoriatic arthritis from May 2019 through Jan. 1, 2020, and were tracked until Nov. 11, 2020.

The ages and races of peoples in the two groups were roughly similar. Overall, 55% were women and 75% were White, and their average age was 58 years. Type 2 diabetes was more common in the psoriasis group than the control group (23% vs. 16%), as was obesity (27% vs. 15%). Of the patients with psoriasis, 60% were on topical treatments, 19% were on oral therapies, and 22% were on biologic therapy, with only a few taking both oral and biologic therapies.

After adjustment for age and gender, patients with psoriasis were 33% more likely than the control group to develop COVID-19 (adjusted incidence rate ratio, 1.33; 95% confidence interval, 1.23-1.38; P < .0001).

In a separate analysis, the gap persisted after adjustment for demographics and comorbidities: Patients with psoriasis had a higher rate of COVID-19 infection vs. controls (adjusted odds ratio, 1.18; 95% CI, 1.13-1.23; P < .0001). Among all patients, non-White race, older age, and comorbidities were all linked to higher risk of COVID-19 (all P < .0001).

Psoriasis might make patients more vulnerable to COVID-19 because the presence of up-regulated genes in psoriatic skin “may lead to systemic hyperinflammation and sensitization of patients with psoriasis to proinflammatory cytokine storm,” Mr. Liu said. This, in turn, may trigger more severe symptomatic disease that requires medical treatment, he said.

Reduced risk, compared with topical therapies

After adjustment for age and gender, those treated with TNF-alpha inhibitors, methotrexate, and apremilast (Otezla) all had statistically lower risks of COVID-19 vs. those on topical therapy (aIRR, 0.82; 95% CI, 0.69-0.95; P < .0029 for TNF-alpha inhibitors; aIRR, 0.75; 95% CI, 0.67-0.86; P < .0001 for methotrexate; and aIRR, 0.69; 95% CI, 0.55-0.85; P < .0006 for apremilast).

Reduced risk held true for those in the separate analysis after adjustment for comorbidities and demographics (respectively, aOR, 0.87; 95% CI, 0.77-1.00; P < .0469; aOR, 0.81; 95% CI, 0.71-0.92; P < .0011; and aOR, 0.70; 95% CI, 0.57-0.87; P < .0014).

Apremilast and methotrexate may boost protection against COVID-19 by inhibiting the body’s production of cytokines, Mr. Liu said.

One message of the study is that “dermatologists should not be scared of prescribing biologics or oral therapies for psoriasis,” the study’s lead author Jashin J. Wu, MD, of the Dermatology Research and Education Foundation in Irvine, Calif., said in an interview.

However, the results on the effects of systemic therapies were not all positive. Interleukin (IL)–17 inhibitors were an outlier: After adjustment for age and gender, patients treated with this class of drugs were 36% more likely to develop COVID-19 than those on oral agents (aIRR, 1.36; 95% CI, 1.13-1.63; P < .0009).

Among patients on biologics, those taking IL-17 inhibitors had the highest risk of COVID-19, Mr. Liu said. “The risk was higher in this class regardless of reference group – general population, the topical cohort, and the oral cohort,” he said. “This may relate to the observation that this biologic class exerts more broad immunosuppressive effects on antiviral host immunity. Notably, large meta-estimates of pivotal trials have observed increased risk of respiratory tract infections for patients on IL-17 inhibitors.”

In an interview, Erica Dommasch, MD, MPH, of the department of dermatology at Beth Israel Deaconess Medical Center, Boston, cautioned that “the data from this study is very hard to interpret.”

It’s likely that some patients with psoriasis on systemic medications “may have been the most careful about limiting exposures,” she said. “Thus, it’s hard to account for behavioral changes in individuals that may have led to the decreased incidence in psoriasis in patients on systemic agents versus topical therapy alone.”

Patients with psoriasis may also be tested more often for COVID-19, and unmeasured comorbidities like chronic kidney disease may play a role too, she said. Still, she added, “it’s reassuring that the authors did not find an increased rate of COVID among psoriasis patients on systemic agents versus topicals alone.” And she agreed with Dr. Wu about the importance of treating psoriasis with therapy beyond topical treatments during the pandemic: “Providers should feel comfortable prescribing systemic medications to psoriasis patients when otherwise appropriate.”

As for the next steps, Dr. Wu said, “we will be exploring more about the prognosis of COVID-19 infection in psoriasis patients. In addition, we will be exploring the relationship of COVID-19 infection with other inflammatory skin diseases, such as atopic dermatitis.”

No study funding is reported. Dr. Wu discloses investigator, consultant, or speaker relationships with AbbVie, Almirall, Amgen, Arcutis, Aristea Therapeutics, Boehringer Ingelheim, Bristol-Myers Squibb, Dermavant, Dr. Reddy’s Laboratories, Eli Lilly, Galderma, Janssen, LEO Pharma, Mindera, Novartis, Regeneron, Sanofi Genzyme, Solius, Sun Pharmaceutical, UCB, Valeant Pharmaceuticals North America, and Zerigo Health. Mr. Liu and Dr. Dommasch have no disclosures.

People with psoriasis have a higher risk of infection with COVID-19 than the general population, but some systemic treatments appear to lower risk in patients, compared with those on topical therapy, a new study finds.

“Our study results suggest that psoriasis is an independent risk factor for COVID-19 illness,” study coauthor Jeffrey Liu, a medical student at the University of Southern California, Los Angeles, said in an interview after he presented the findings at the American Academy of Dermatology Virtual Meeting Experience. “And our findings are consistent with the hypothesis that certain systemic agents may confer a protective effect against COVID-19 illness.”

Mr. Liu and coinvestigators used a Symphony Health dataset to analyze the health records of 167,027 U.S. patients diagnosed with psoriasis and a control group of 1,002,162 patients. The participants, all at least 20 years old, had been treated for psoriasis or psoriatic arthritis from May 2019 through Jan. 1, 2020, and were tracked until Nov. 11, 2020.

The ages and races of peoples in the two groups were roughly similar. Overall, 55% were women and 75% were White, and their average age was 58 years. Type 2 diabetes was more common in the psoriasis group than the control group (23% vs. 16%), as was obesity (27% vs. 15%). Of the patients with psoriasis, 60% were on topical treatments, 19% were on oral therapies, and 22% were on biologic therapy, with only a few taking both oral and biologic therapies.

After adjustment for age and gender, patients with psoriasis were 33% more likely than the control group to develop COVID-19 (adjusted incidence rate ratio, 1.33; 95% confidence interval, 1.23-1.38; P < .0001).

In a separate analysis, the gap persisted after adjustment for demographics and comorbidities: Patients with psoriasis had a higher rate of COVID-19 infection vs. controls (adjusted odds ratio, 1.18; 95% CI, 1.13-1.23; P < .0001). Among all patients, non-White race, older age, and comorbidities were all linked to higher risk of COVID-19 (all P < .0001).

Psoriasis might make patients more vulnerable to COVID-19 because the presence of up-regulated genes in psoriatic skin “may lead to systemic hyperinflammation and sensitization of patients with psoriasis to proinflammatory cytokine storm,” Mr. Liu said. This, in turn, may trigger more severe symptomatic disease that requires medical treatment, he said.

Reduced risk, compared with topical therapies

After adjustment for age and gender, those treated with TNF-alpha inhibitors, methotrexate, and apremilast (Otezla) all had statistically lower risks of COVID-19 vs. those on topical therapy (aIRR, 0.82; 95% CI, 0.69-0.95; P < .0029 for TNF-alpha inhibitors; aIRR, 0.75; 95% CI, 0.67-0.86; P < .0001 for methotrexate; and aIRR, 0.69; 95% CI, 0.55-0.85; P < .0006 for apremilast).

Reduced risk held true for those in the separate analysis after adjustment for comorbidities and demographics (respectively, aOR, 0.87; 95% CI, 0.77-1.00; P < .0469; aOR, 0.81; 95% CI, 0.71-0.92; P < .0011; and aOR, 0.70; 95% CI, 0.57-0.87; P < .0014).

Apremilast and methotrexate may boost protection against COVID-19 by inhibiting the body’s production of cytokines, Mr. Liu said.

One message of the study is that “dermatologists should not be scared of prescribing biologics or oral therapies for psoriasis,” the study’s lead author Jashin J. Wu, MD, of the Dermatology Research and Education Foundation in Irvine, Calif., said in an interview.

However, the results on the effects of systemic therapies were not all positive. Interleukin (IL)–17 inhibitors were an outlier: After adjustment for age and gender, patients treated with this class of drugs were 36% more likely to develop COVID-19 than those on oral agents (aIRR, 1.36; 95% CI, 1.13-1.63; P < .0009).

Among patients on biologics, those taking IL-17 inhibitors had the highest risk of COVID-19, Mr. Liu said. “The risk was higher in this class regardless of reference group – general population, the topical cohort, and the oral cohort,” he said. “This may relate to the observation that this biologic class exerts more broad immunosuppressive effects on antiviral host immunity. Notably, large meta-estimates of pivotal trials have observed increased risk of respiratory tract infections for patients on IL-17 inhibitors.”

In an interview, Erica Dommasch, MD, MPH, of the department of dermatology at Beth Israel Deaconess Medical Center, Boston, cautioned that “the data from this study is very hard to interpret.”

It’s likely that some patients with psoriasis on systemic medications “may have been the most careful about limiting exposures,” she said. “Thus, it’s hard to account for behavioral changes in individuals that may have led to the decreased incidence in psoriasis in patients on systemic agents versus topical therapy alone.”

Patients with psoriasis may also be tested more often for COVID-19, and unmeasured comorbidities like chronic kidney disease may play a role too, she said. Still, she added, “it’s reassuring that the authors did not find an increased rate of COVID among psoriasis patients on systemic agents versus topicals alone.” And she agreed with Dr. Wu about the importance of treating psoriasis with therapy beyond topical treatments during the pandemic: “Providers should feel comfortable prescribing systemic medications to psoriasis patients when otherwise appropriate.”

As for the next steps, Dr. Wu said, “we will be exploring more about the prognosis of COVID-19 infection in psoriasis patients. In addition, we will be exploring the relationship of COVID-19 infection with other inflammatory skin diseases, such as atopic dermatitis.”

No study funding is reported. Dr. Wu discloses investigator, consultant, or speaker relationships with AbbVie, Almirall, Amgen, Arcutis, Aristea Therapeutics, Boehringer Ingelheim, Bristol-Myers Squibb, Dermavant, Dr. Reddy’s Laboratories, Eli Lilly, Galderma, Janssen, LEO Pharma, Mindera, Novartis, Regeneron, Sanofi Genzyme, Solius, Sun Pharmaceutical, UCB, Valeant Pharmaceuticals North America, and Zerigo Health. Mr. Liu and Dr. Dommasch have no disclosures.

People with psoriasis have a higher risk of infection with COVID-19 than the general population, but some systemic treatments appear to lower risk in patients, compared with those on topical therapy, a new study finds.

“Our study results suggest that psoriasis is an independent risk factor for COVID-19 illness,” study coauthor Jeffrey Liu, a medical student at the University of Southern California, Los Angeles, said in an interview after he presented the findings at the American Academy of Dermatology Virtual Meeting Experience. “And our findings are consistent with the hypothesis that certain systemic agents may confer a protective effect against COVID-19 illness.”

Mr. Liu and coinvestigators used a Symphony Health dataset to analyze the health records of 167,027 U.S. patients diagnosed with psoriasis and a control group of 1,002,162 patients. The participants, all at least 20 years old, had been treated for psoriasis or psoriatic arthritis from May 2019 through Jan. 1, 2020, and were tracked until Nov. 11, 2020.

The ages and races of peoples in the two groups were roughly similar. Overall, 55% were women and 75% were White, and their average age was 58 years. Type 2 diabetes was more common in the psoriasis group than the control group (23% vs. 16%), as was obesity (27% vs. 15%). Of the patients with psoriasis, 60% were on topical treatments, 19% were on oral therapies, and 22% were on biologic therapy, with only a few taking both oral and biologic therapies.

After adjustment for age and gender, patients with psoriasis were 33% more likely than the control group to develop COVID-19 (adjusted incidence rate ratio, 1.33; 95% confidence interval, 1.23-1.38; P < .0001).

In a separate analysis, the gap persisted after adjustment for demographics and comorbidities: Patients with psoriasis had a higher rate of COVID-19 infection vs. controls (adjusted odds ratio, 1.18; 95% CI, 1.13-1.23; P < .0001). Among all patients, non-White race, older age, and comorbidities were all linked to higher risk of COVID-19 (all P < .0001).

Psoriasis might make patients more vulnerable to COVID-19 because the presence of up-regulated genes in psoriatic skin “may lead to systemic hyperinflammation and sensitization of patients with psoriasis to proinflammatory cytokine storm,” Mr. Liu said. This, in turn, may trigger more severe symptomatic disease that requires medical treatment, he said.

Reduced risk, compared with topical therapies

After adjustment for age and gender, those treated with TNF-alpha inhibitors, methotrexate, and apremilast (Otezla) all had statistically lower risks of COVID-19 vs. those on topical therapy (aIRR, 0.82; 95% CI, 0.69-0.95; P < .0029 for TNF-alpha inhibitors; aIRR, 0.75; 95% CI, 0.67-0.86; P < .0001 for methotrexate; and aIRR, 0.69; 95% CI, 0.55-0.85; P < .0006 for apremilast).

Reduced risk held true for those in the separate analysis after adjustment for comorbidities and demographics (respectively, aOR, 0.87; 95% CI, 0.77-1.00; P < .0469; aOR, 0.81; 95% CI, 0.71-0.92; P < .0011; and aOR, 0.70; 95% CI, 0.57-0.87; P < .0014).

Apremilast and methotrexate may boost protection against COVID-19 by inhibiting the body’s production of cytokines, Mr. Liu said.

One message of the study is that “dermatologists should not be scared of prescribing biologics or oral therapies for psoriasis,” the study’s lead author Jashin J. Wu, MD, of the Dermatology Research and Education Foundation in Irvine, Calif., said in an interview.

However, the results on the effects of systemic therapies were not all positive. Interleukin (IL)–17 inhibitors were an outlier: After adjustment for age and gender, patients treated with this class of drugs were 36% more likely to develop COVID-19 than those on oral agents (aIRR, 1.36; 95% CI, 1.13-1.63; P < .0009).

Among patients on biologics, those taking IL-17 inhibitors had the highest risk of COVID-19, Mr. Liu said. “The risk was higher in this class regardless of reference group – general population, the topical cohort, and the oral cohort,” he said. “This may relate to the observation that this biologic class exerts more broad immunosuppressive effects on antiviral host immunity. Notably, large meta-estimates of pivotal trials have observed increased risk of respiratory tract infections for patients on IL-17 inhibitors.”

In an interview, Erica Dommasch, MD, MPH, of the department of dermatology at Beth Israel Deaconess Medical Center, Boston, cautioned that “the data from this study is very hard to interpret.”

It’s likely that some patients with psoriasis on systemic medications “may have been the most careful about limiting exposures,” she said. “Thus, it’s hard to account for behavioral changes in individuals that may have led to the decreased incidence in psoriasis in patients on systemic agents versus topical therapy alone.”

Patients with psoriasis may also be tested more often for COVID-19, and unmeasured comorbidities like chronic kidney disease may play a role too, she said. Still, she added, “it’s reassuring that the authors did not find an increased rate of COVID among psoriasis patients on systemic agents versus topicals alone.” And she agreed with Dr. Wu about the importance of treating psoriasis with therapy beyond topical treatments during the pandemic: “Providers should feel comfortable prescribing systemic medications to psoriasis patients when otherwise appropriate.”

As for the next steps, Dr. Wu said, “we will be exploring more about the prognosis of COVID-19 infection in psoriasis patients. In addition, we will be exploring the relationship of COVID-19 infection with other inflammatory skin diseases, such as atopic dermatitis.”

No study funding is reported. Dr. Wu discloses investigator, consultant, or speaker relationships with AbbVie, Almirall, Amgen, Arcutis, Aristea Therapeutics, Boehringer Ingelheim, Bristol-Myers Squibb, Dermavant, Dr. Reddy’s Laboratories, Eli Lilly, Galderma, Janssen, LEO Pharma, Mindera, Novartis, Regeneron, Sanofi Genzyme, Solius, Sun Pharmaceutical, UCB, Valeant Pharmaceuticals North America, and Zerigo Health. Mr. Liu and Dr. Dommasch have no disclosures.

The order in which tocilizumab (Actemra) is used in the sequence of treatments for rheumatoid arthritis could be muddying the waters when it comes to evaluating patients’ risk for serious infection.

According to new data emerging from the British Society for Rheumatology Biologics Register – Rheumatoid Arthritis (BSRBR-RA), the line of therapy is a confounding factor when examining the risk for serious infection with not only tocilizumab but also other biologic agents.

The good news for patients, however, is that there doesn’t appear to be any overall greater risk for serious infection with one biologic over another when the line of therapy is taken into account.

“We don’t have any strong signal that there is an increased risk of serious infections with tocilizumab, compared to TNF inhibitors,” rheumatologist Kim Lauper, MD, of Geneva University Hospitals, said in an interview after presenting the data at the annual conference of the British Society for Rheumatology.

This is in contrast to studies where an increased risk of infections with tocilizumab has been seen when compared to TNF inhibitors. However, those studies did not account for the line of therapy, explained Dr. Lauper, who is also a clinical research fellow in the Centre for Epidemiology Versus Arthritis at the University of Manchester (England), where the BSRBR-RA is managed.

“Tocilizumab is a treatment that we often give to patients after several other treatments, so they’re really different patients,” Dr. Lauper observed. Indeed, in the “real-world” setting, patients taking tocilizumab tend to be older, have longer disease duration, and have worse functional status than do those who might receive other biologics.

To look at the effect of line of therapy on the serious infection risk associated with commonly used biologic drugs, Dr. Lauper and associates examined data on more than 33,000 treatment courses, representing more than 62,500 patient-years.

Using etanercept as the comparator – because it represents the largest group of patients in the BSRBR-RA – the serious infection risk for tocilizumab, rituximab, adalimumab, infliximab, certolizumab pegol, and abatacept were calculated as an overall rate, and for their use as first-, second-, third-, fourth-, or fifth-line therapy.

The researchers adjusted their analysis for some clear baseline differences between the treatment groups, including age, prior treatment, disease duration, and comorbidities. Seropositivity, smoking status, general health status, and disease activity scores were also adjusted for in the analysis.

Crude hazard ratios (HRs), compared with etanercept, before and after adjusting for these already-known confounding factors were 1.0 and 1.2 for tocilizumab, 1.1 and 1.1 for adalimumab, 1.4 and 1.3 for infliximab, 0.6 and 0.8 for certolizumab pegol, 0.9 and 1.0 for rituximab, and 0.9 and 1.2 for abatacept.

Stratifying by line of therapy, however, changed the results: HRs were no longer significantly different, compared with etanercept, for tocilizumab, adalimumab, and infliximab for most lines of therapy.

Indeed, while the risk for serious infection occurring with tocilizumab was 20% higher overall, compared with etanercept, that risk was actually lower if tocilizumab had been used as first- or fifth-line therapy (HRs for both, 0.9) but higher if it had been used as a third- or fourth-line therapy (HR of 1.4 for both).

“We often use tocilizumab as a second-line, third-line, or even fourth-line therapy, and if we don’t adjust for anything, we can have the impression that there are more infections with tocilizumab. But then, when we adjust for confounding factors and the line of therapy, we don’t have this anymore,” Dr. Lauper said.

“Line of therapy in itself is not a risk for serious infections,” she said in qualifying the conclusions that could be drawn from the study. “It may be a marker of the disease or some patient characteristic that is associated with a higher risk of infections.” Nevertheless, it should be taken into account when evaluating serious outcomes and possibly other safety and effectiveness outcomes.

“I understand concentrating on the hospitalized infections because the data are so much more robust,” observed consultant rheumatologist Jon Packham, BM, DM, of Haywood Hospital in Stoke-on-Trent, England, who chaired the session. He queried if there were any data on milder or just antibiotic-treated infections. At present, there aren’t those data to look at, Dr. Lauper responded, as this is something that’s difficult for registers to capture because doctors often do not log them in the databases.

There are also too few data on Janus kinase (JAK) inhibitors currently in the BSRBR-RA at present to be able to look at their rate of serious infection by line of therapy, Dr. Lauper noted. Because JAK inhibitors act on cytokines different from those affected by biologics for RA, there may be a difference there, but more data are needed on the JAK inhibitors before that question can be analyzed.

Dr. Lauper did not state having any disclosures. The BSRBR-RA is funded by the BSR via restricted income grants from several U.K. pharmaceutical companies, which has included or currently includes AbbVie, Celltrion, Hospira, Pfizer, UCB, Roche, Swedish Orphan Biovitrum, and Merck.

The order in which tocilizumab (Actemra) is used in the sequence of treatments for rheumatoid arthritis could be muddying the waters when it comes to evaluating patients’ risk for serious infection.

According to new data emerging from the British Society for Rheumatology Biologics Register – Rheumatoid Arthritis (BSRBR-RA), the line of therapy is a confounding factor when examining the risk for serious infection with not only tocilizumab but also other biologic agents.

The good news for patients, however, is that there doesn’t appear to be any overall greater risk for serious infection with one biologic over another when the line of therapy is taken into account.

“We don’t have any strong signal that there is an increased risk of serious infections with tocilizumab, compared to TNF inhibitors,” rheumatologist Kim Lauper, MD, of Geneva University Hospitals, said in an interview after presenting the data at the annual conference of the British Society for Rheumatology.

This is in contrast to studies where an increased risk of infections with tocilizumab has been seen when compared to TNF inhibitors. However, those studies did not account for the line of therapy, explained Dr. Lauper, who is also a clinical research fellow in the Centre for Epidemiology Versus Arthritis at the University of Manchester (England), where the BSRBR-RA is managed.

“Tocilizumab is a treatment that we often give to patients after several other treatments, so they’re really different patients,” Dr. Lauper observed. Indeed, in the “real-world” setting, patients taking tocilizumab tend to be older, have longer disease duration, and have worse functional status than do those who might receive other biologics.

To look at the effect of line of therapy on the serious infection risk associated with commonly used biologic drugs, Dr. Lauper and associates examined data on more than 33,000 treatment courses, representing more than 62,500 patient-years.

Using etanercept as the comparator – because it represents the largest group of patients in the BSRBR-RA – the serious infection risk for tocilizumab, rituximab, adalimumab, infliximab, certolizumab pegol, and abatacept were calculated as an overall rate, and for their use as first-, second-, third-, fourth-, or fifth-line therapy.

The researchers adjusted their analysis for some clear baseline differences between the treatment groups, including age, prior treatment, disease duration, and comorbidities. Seropositivity, smoking status, general health status, and disease activity scores were also adjusted for in the analysis.

Crude hazard ratios (HRs), compared with etanercept, before and after adjusting for these already-known confounding factors were 1.0 and 1.2 for tocilizumab, 1.1 and 1.1 for adalimumab, 1.4 and 1.3 for infliximab, 0.6 and 0.8 for certolizumab pegol, 0.9 and 1.0 for rituximab, and 0.9 and 1.2 for abatacept.

Stratifying by line of therapy, however, changed the results: HRs were no longer significantly different, compared with etanercept, for tocilizumab, adalimumab, and infliximab for most lines of therapy.

Indeed, while the risk for serious infection occurring with tocilizumab was 20% higher overall, compared with etanercept, that risk was actually lower if tocilizumab had been used as first- or fifth-line therapy (HRs for both, 0.9) but higher if it had been used as a third- or fourth-line therapy (HR of 1.4 for both).

“We often use tocilizumab as a second-line, third-line, or even fourth-line therapy, and if we don’t adjust for anything, we can have the impression that there are more infections with tocilizumab. But then, when we adjust for confounding factors and the line of therapy, we don’t have this anymore,” Dr. Lauper said.

“Line of therapy in itself is not a risk for serious infections,” she said in qualifying the conclusions that could be drawn from the study. “It may be a marker of the disease or some patient characteristic that is associated with a higher risk of infections.” Nevertheless, it should be taken into account when evaluating serious outcomes and possibly other safety and effectiveness outcomes.

“I understand concentrating on the hospitalized infections because the data are so much more robust,” observed consultant rheumatologist Jon Packham, BM, DM, of Haywood Hospital in Stoke-on-Trent, England, who chaired the session. He queried if there were any data on milder or just antibiotic-treated infections. At present, there aren’t those data to look at, Dr. Lauper responded, as this is something that’s difficult for registers to capture because doctors often do not log them in the databases.

There are also too few data on Janus kinase (JAK) inhibitors currently in the BSRBR-RA at present to be able to look at their rate of serious infection by line of therapy, Dr. Lauper noted. Because JAK inhibitors act on cytokines different from those affected by biologics for RA, there may be a difference there, but more data are needed on the JAK inhibitors before that question can be analyzed.

Dr. Lauper did not state having any disclosures. The BSRBR-RA is funded by the BSR via restricted income grants from several U.K. pharmaceutical companies, which has included or currently includes AbbVie, Celltrion, Hospira, Pfizer, UCB, Roche, Swedish Orphan Biovitrum, and Merck.

The order in which tocilizumab (Actemra) is used in the sequence of treatments for rheumatoid arthritis could be muddying the waters when it comes to evaluating patients’ risk for serious infection.

According to new data emerging from the British Society for Rheumatology Biologics Register – Rheumatoid Arthritis (BSRBR-RA), the line of therapy is a confounding factor when examining the risk for serious infection with not only tocilizumab but also other biologic agents.

The good news for patients, however, is that there doesn’t appear to be any overall greater risk for serious infection with one biologic over another when the line of therapy is taken into account.

“We don’t have any strong signal that there is an increased risk of serious infections with tocilizumab, compared to TNF inhibitors,” rheumatologist Kim Lauper, MD, of Geneva University Hospitals, said in an interview after presenting the data at the annual conference of the British Society for Rheumatology.

This is in contrast to studies where an increased risk of infections with tocilizumab has been seen when compared to TNF inhibitors. However, those studies did not account for the line of therapy, explained Dr. Lauper, who is also a clinical research fellow in the Centre for Epidemiology Versus Arthritis at the University of Manchester (England), where the BSRBR-RA is managed.

“Tocilizumab is a treatment that we often give to patients after several other treatments, so they’re really different patients,” Dr. Lauper observed. Indeed, in the “real-world” setting, patients taking tocilizumab tend to be older, have longer disease duration, and have worse functional status than do those who might receive other biologics.

To look at the effect of line of therapy on the serious infection risk associated with commonly used biologic drugs, Dr. Lauper and associates examined data on more than 33,000 treatment courses, representing more than 62,500 patient-years.

Using etanercept as the comparator – because it represents the largest group of patients in the BSRBR-RA – the serious infection risk for tocilizumab, rituximab, adalimumab, infliximab, certolizumab pegol, and abatacept were calculated as an overall rate, and for their use as first-, second-, third-, fourth-, or fifth-line therapy.

The researchers adjusted their analysis for some clear baseline differences between the treatment groups, including age, prior treatment, disease duration, and comorbidities. Seropositivity, smoking status, general health status, and disease activity scores were also adjusted for in the analysis.

Crude hazard ratios (HRs), compared with etanercept, before and after adjusting for these already-known confounding factors were 1.0 and 1.2 for tocilizumab, 1.1 and 1.1 for adalimumab, 1.4 and 1.3 for infliximab, 0.6 and 0.8 for certolizumab pegol, 0.9 and 1.0 for rituximab, and 0.9 and 1.2 for abatacept.

Stratifying by line of therapy, however, changed the results: HRs were no longer significantly different, compared with etanercept, for tocilizumab, adalimumab, and infliximab for most lines of therapy.

Indeed, while the risk for serious infection occurring with tocilizumab was 20% higher overall, compared with etanercept, that risk was actually lower if tocilizumab had been used as first- or fifth-line therapy (HRs for both, 0.9) but higher if it had been used as a third- or fourth-line therapy (HR of 1.4 for both).

“We often use tocilizumab as a second-line, third-line, or even fourth-line therapy, and if we don’t adjust for anything, we can have the impression that there are more infections with tocilizumab. But then, when we adjust for confounding factors and the line of therapy, we don’t have this anymore,” Dr. Lauper said.

“Line of therapy in itself is not a risk for serious infections,” she said in qualifying the conclusions that could be drawn from the study. “It may be a marker of the disease or some patient characteristic that is associated with a higher risk of infections.” Nevertheless, it should be taken into account when evaluating serious outcomes and possibly other safety and effectiveness outcomes.

“I understand concentrating on the hospitalized infections because the data are so much more robust,” observed consultant rheumatologist Jon Packham, BM, DM, of Haywood Hospital in Stoke-on-Trent, England, who chaired the session. He queried if there were any data on milder or just antibiotic-treated infections. At present, there aren’t those data to look at, Dr. Lauper responded, as this is something that’s difficult for registers to capture because doctors often do not log them in the databases.

There are also too few data on Janus kinase (JAK) inhibitors currently in the BSRBR-RA at present to be able to look at their rate of serious infection by line of therapy, Dr. Lauper noted. Because JAK inhibitors act on cytokines different from those affected by biologics for RA, there may be a difference there, but more data are needed on the JAK inhibitors before that question can be analyzed.

Dr. Lauper did not state having any disclosures. The BSRBR-RA is funded by the BSR via restricted income grants from several U.K. pharmaceutical companies, which has included or currently includes AbbVie, Celltrion, Hospira, Pfizer, UCB, Roche, Swedish Orphan Biovitrum, and Merck.

After hinting that new guidelines on outdoor mask-wearing were coming, the Centers for Disease Control and Prevention on April 27 officially gave a green light to fully vaccinated people gathering outside in uncrowded activities without the masks that have become so common during the COVID-19 pandemic.

It is a minor – but still significant – step toward the end of pandemic restrictions.

“Over the past year, we have spent a lot of time telling Americans what they cannot do, what they should not do,” CDC director Rochelle Walensky, MD, MPH, said at a White House press briefing. “Today, I’m going to tell you some of the things you can do if you are fully vaccinated.”

President Joe Biden affirmed the new guidelines at a press conference soon after the CDC briefing ended.

“Starting today, if you are fully vaccinated and you’re outdoors and not in a big crowd, you no longer need to wear a mask,” he said, adding “the bottom line is clear: If you’re vaccinated, you can do more things, more safely, both outdoors as well as indoors.”

President Biden emphasized the role science played in the decision, saying “The CDC is able to make this announcement because our scientists are convinced by the data that the odds of getting or giving the virus to others is very, very low if you’ve both been fully vaccinated and are out in the open air.”

President Biden also said these new guidelines should be an incentive for more people to get vaccinated. “This is another great reason to go get vaccinated now. Now,” he said.

The CDC has long advised that outdoor activities are safer than indoor activities.

“Most of transmission is happening indoors rather than outdoors. Less than 10% of documented transmissions in many studies have occurred outdoors,” said Dr. Walensky. “We also know there’s almost a 20-fold increased risk of transmission in the indoor setting, than the outdoor setting.”

Dr. Walensky said the lower risks outdoors, combined with growing vaccination coverage and falling COVID cases around the country, motivated the change.

The new guidelines come as the share of people in the United States who are vaccinated is growing. About 37% of all eligible Americans are fully vaccinated, according to the CDC. Nearly 54% have had at least one dose.

The new guidelines say unvaccinated people should continue to wear masks outdoors when gathering with others or dining at an outdoor restaurant.

And vaccinated people should continue to wear masks outdoors in crowded settings where social distancing might not always be possible, like a concert or sporting event. People are considered fully vaccinated when they are 2 weeks past their last shot

The CDC guidelines say people who live in the same house don’t need to wear masks if they’re exercising or hanging out together outdoors.

You also don’t need a mask if you’re attending a small, outdoor gathering with fully vaccinated family and friends, whether you’re vaccinated or not.

The new guidelines also say it’s OK for fully vaccinated people to take their masks off outdoors when gathering in a small group of vaccinated and unvaccinated people, but suggest that unvaccinated people should still wear a mask.



Reporter Marcia Frellick contributed to this report.

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

After hinting that new guidelines on outdoor mask-wearing were coming, the Centers for Disease Control and Prevention on April 27 officially gave a green light to fully vaccinated people gathering outside in uncrowded activities without the masks that have become so common during the COVID-19 pandemic.

It is a minor – but still significant – step toward the end of pandemic restrictions.

“Over the past year, we have spent a lot of time telling Americans what they cannot do, what they should not do,” CDC director Rochelle Walensky, MD, MPH, said at a White House press briefing. “Today, I’m going to tell you some of the things you can do if you are fully vaccinated.”

President Joe Biden affirmed the new guidelines at a press conference soon after the CDC briefing ended.

“Starting today, if you are fully vaccinated and you’re outdoors and not in a big crowd, you no longer need to wear a mask,” he said, adding “the bottom line is clear: If you’re vaccinated, you can do more things, more safely, both outdoors as well as indoors.”

President Biden emphasized the role science played in the decision, saying “The CDC is able to make this announcement because our scientists are convinced by the data that the odds of getting or giving the virus to others is very, very low if you’ve both been fully vaccinated and are out in the open air.”

President Biden also said these new guidelines should be an incentive for more people to get vaccinated. “This is another great reason to go get vaccinated now. Now,” he said.

The CDC has long advised that outdoor activities are safer than indoor activities.

“Most of transmission is happening indoors rather than outdoors. Less than 10% of documented transmissions in many studies have occurred outdoors,” said Dr. Walensky. “We also know there’s almost a 20-fold increased risk of transmission in the indoor setting, than the outdoor setting.”

Dr. Walensky said the lower risks outdoors, combined with growing vaccination coverage and falling COVID cases around the country, motivated the change.

The new guidelines come as the share of people in the United States who are vaccinated is growing. About 37% of all eligible Americans are fully vaccinated, according to the CDC. Nearly 54% have had at least one dose.

The new guidelines say unvaccinated people should continue to wear masks outdoors when gathering with others or dining at an outdoor restaurant.

And vaccinated people should continue to wear masks outdoors in crowded settings where social distancing might not always be possible, like a concert or sporting event. People are considered fully vaccinated when they are 2 weeks past their last shot

The CDC guidelines say people who live in the same house don’t need to wear masks if they’re exercising or hanging out together outdoors.

You also don’t need a mask if you’re attending a small, outdoor gathering with fully vaccinated family and friends, whether you’re vaccinated or not.

The new guidelines also say it’s OK for fully vaccinated people to take their masks off outdoors when gathering in a small group of vaccinated and unvaccinated people, but suggest that unvaccinated people should still wear a mask.



Reporter Marcia Frellick contributed to this report.

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

After hinting that new guidelines on outdoor mask-wearing were coming, the Centers for Disease Control and Prevention on April 27 officially gave a green light to fully vaccinated people gathering outside in uncrowded activities without the masks that have become so common during the COVID-19 pandemic.

It is a minor – but still significant – step toward the end of pandemic restrictions.

“Over the past year, we have spent a lot of time telling Americans what they cannot do, what they should not do,” CDC director Rochelle Walensky, MD, MPH, said at a White House press briefing. “Today, I’m going to tell you some of the things you can do if you are fully vaccinated.”

President Joe Biden affirmed the new guidelines at a press conference soon after the CDC briefing ended.

“Starting today, if you are fully vaccinated and you’re outdoors and not in a big crowd, you no longer need to wear a mask,” he said, adding “the bottom line is clear: If you’re vaccinated, you can do more things, more safely, both outdoors as well as indoors.”

President Biden emphasized the role science played in the decision, saying “The CDC is able to make this announcement because our scientists are convinced by the data that the odds of getting or giving the virus to others is very, very low if you’ve both been fully vaccinated and are out in the open air.”

President Biden also said these new guidelines should be an incentive for more people to get vaccinated. “This is another great reason to go get vaccinated now. Now,” he said.

The CDC has long advised that outdoor activities are safer than indoor activities.

“Most of transmission is happening indoors rather than outdoors. Less than 10% of documented transmissions in many studies have occurred outdoors,” said Dr. Walensky. “We also know there’s almost a 20-fold increased risk of transmission in the indoor setting, than the outdoor setting.”

Dr. Walensky said the lower risks outdoors, combined with growing vaccination coverage and falling COVID cases around the country, motivated the change.

The new guidelines come as the share of people in the United States who are vaccinated is growing. About 37% of all eligible Americans are fully vaccinated, according to the CDC. Nearly 54% have had at least one dose.

The new guidelines say unvaccinated people should continue to wear masks outdoors when gathering with others or dining at an outdoor restaurant.

And vaccinated people should continue to wear masks outdoors in crowded settings where social distancing might not always be possible, like a concert or sporting event. People are considered fully vaccinated when they are 2 weeks past their last shot

The CDC guidelines say people who live in the same house don’t need to wear masks if they’re exercising or hanging out together outdoors.

You also don’t need a mask if you’re attending a small, outdoor gathering with fully vaccinated family and friends, whether you’re vaccinated or not.

The new guidelines also say it’s OK for fully vaccinated people to take their masks off outdoors when gathering in a small group of vaccinated and unvaccinated people, but suggest that unvaccinated people should still wear a mask.



Reporter Marcia Frellick contributed to this report.

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

On April 23, the Committee for Medicinal Products for Human Use of the European Medicines Agency issued a positive opinion for the IL-13 inhibitor tralokinumab (Adtralza) for the treatment of adults with moderate to severe atopic dermatitis (AD) who are eligible for systemic therapy.

The new opinion represents the final stages before the European Commission decides whether tralokinumab will be authorized for use throughout the European Union. The final decision should be made in the next few months.

If ultimately authorized, tralokinumab would become the first approved fully human monoclonal antibody targeting the interleukin-13 cytokine, a key factor that drives the signs and symptoms of AD. Tralokinumab has previously shown to target IL-13 with high affinity and subsequently improve symptoms associated with the inflammatory skin disease.

The EMA accepted the marketing application for tralokinumab back in June 2020. Submitted alongside the marketing application were data from the ECZTRA 1, 2, and 3 pivotal randomized, placebo-controlled trials.

In the ECZTRA trials, treatment with tralokinumab, either alone or with topical corticosteroids, was associated with significant improvements in the Investigator Global Assessment score of clear or almost clear skin and at least a 75% improvement in the Eczema Area and Severity Index score. Safety of tralokinumab in these trials was comparable with that reported with placebo.

Interim data from the open-label extension trial, ECZTEND, also showed that treatment with tralokinumab was associated with durable efficacy in adult patients with moderate to severe AD. Patients in this study were previously enrolled in the ECZTRA 1 and 2 parent trials and had received the IL-13 inhibitor for up to 2 years. Data from this trial were presented at the 2021 American Academy of Dermatology Virtual Meeting Experience.

Pending the European Commission’s final decision, the Marketing Authorization Application for use of tralokinumab in adults with moderate to severe AD will be valid in across all European Union member states in addition to Iceland, Norway, and Liechtenstein. Other regulatory filings for the drug are currently underway with health authorities from various countries worldwide.

Back in July 2020, the Food and Drug Administration accepted a Biologics License Application for tralokinumab for the treatment of moderate to severe AD in adults. Data from the pivotal ECZTRA 1, 2, and ECZTRA 3 trials were submitted to the FDA.

The FDA expects to make a final decision in the second quarter of this year on whether to approve tralokinumab in the United States for the adult AD indication.

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

On April 23, the Committee for Medicinal Products for Human Use of the European Medicines Agency issued a positive opinion for the IL-13 inhibitor tralokinumab (Adtralza) for the treatment of adults with moderate to severe atopic dermatitis (AD) who are eligible for systemic therapy.

The new opinion represents the final stages before the European Commission decides whether tralokinumab will be authorized for use throughout the European Union. The final decision should be made in the next few months.

If ultimately authorized, tralokinumab would become the first approved fully human monoclonal antibody targeting the interleukin-13 cytokine, a key factor that drives the signs and symptoms of AD. Tralokinumab has previously shown to target IL-13 with high affinity and subsequently improve symptoms associated with the inflammatory skin disease.

The EMA accepted the marketing application for tralokinumab back in June 2020. Submitted alongside the marketing application were data from the ECZTRA 1, 2, and 3 pivotal randomized, placebo-controlled trials.

In the ECZTRA trials, treatment with tralokinumab, either alone or with topical corticosteroids, was associated with significant improvements in the Investigator Global Assessment score of clear or almost clear skin and at least a 75% improvement in the Eczema Area and Severity Index score. Safety of tralokinumab in these trials was comparable with that reported with placebo.

Interim data from the open-label extension trial, ECZTEND, also showed that treatment with tralokinumab was associated with durable efficacy in adult patients with moderate to severe AD. Patients in this study were previously enrolled in the ECZTRA 1 and 2 parent trials and had received the IL-13 inhibitor for up to 2 years. Data from this trial were presented at the 2021 American Academy of Dermatology Virtual Meeting Experience.

Pending the European Commission’s final decision, the Marketing Authorization Application for use of tralokinumab in adults with moderate to severe AD will be valid in across all European Union member states in addition to Iceland, Norway, and Liechtenstein. Other regulatory filings for the drug are currently underway with health authorities from various countries worldwide.

Back in July 2020, the Food and Drug Administration accepted a Biologics License Application for tralokinumab for the treatment of moderate to severe AD in adults. Data from the pivotal ECZTRA 1, 2, and ECZTRA 3 trials were submitted to the FDA.

The FDA expects to make a final decision in the second quarter of this year on whether to approve tralokinumab in the United States for the adult AD indication.

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

On April 23, the Committee for Medicinal Products for Human Use of the European Medicines Agency issued a positive opinion for the IL-13 inhibitor tralokinumab (Adtralza) for the treatment of adults with moderate to severe atopic dermatitis (AD) who are eligible for systemic therapy.

The new opinion represents the final stages before the European Commission decides whether tralokinumab will be authorized for use throughout the European Union. The final decision should be made in the next few months.

If ultimately authorized, tralokinumab would become the first approved fully human monoclonal antibody targeting the interleukin-13 cytokine, a key factor that drives the signs and symptoms of AD. Tralokinumab has previously shown to target IL-13 with high affinity and subsequently improve symptoms associated with the inflammatory skin disease.

The EMA accepted the marketing application for tralokinumab back in June 2020. Submitted alongside the marketing application were data from the ECZTRA 1, 2, and 3 pivotal randomized, placebo-controlled trials.

In the ECZTRA trials, treatment with tralokinumab, either alone or with topical corticosteroids, was associated with significant improvements in the Investigator Global Assessment score of clear or almost clear skin and at least a 75% improvement in the Eczema Area and Severity Index score. Safety of tralokinumab in these trials was comparable with that reported with placebo.

Interim data from the open-label extension trial, ECZTEND, also showed that treatment with tralokinumab was associated with durable efficacy in adult patients with moderate to severe AD. Patients in this study were previously enrolled in the ECZTRA 1 and 2 parent trials and had received the IL-13 inhibitor for up to 2 years. Data from this trial were presented at the 2021 American Academy of Dermatology Virtual Meeting Experience.

Pending the European Commission’s final decision, the Marketing Authorization Application for use of tralokinumab in adults with moderate to severe AD will be valid in across all European Union member states in addition to Iceland, Norway, and Liechtenstein. Other regulatory filings for the drug are currently underway with health authorities from various countries worldwide.

Back in July 2020, the Food and Drug Administration accepted a Biologics License Application for tralokinumab for the treatment of moderate to severe AD in adults. Data from the pivotal ECZTRA 1, 2, and ECZTRA 3 trials were submitted to the FDA.

The FDA expects to make a final decision in the second quarter of this year on whether to approve tralokinumab in the United States for the adult AD indication.

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

The Pfizer and Moderna COVID-19 vaccines appear to be safe in pregnant patients, according to preliminary findings published in the New England Journal of Medicine.

The Centers for Disease Control and Prevention have said pregnant people have an increased risk of being severely ill from COVID-19; however, this group was excluded from major clinical trials that led up to the current vaccine approvals.

But based on the new findings, Rochelle Walensky, MD, director of the CDC, announced during a White House COVID-19 briefing that the CDC recommends that pregnant people receive the COVID-19 vaccine.

The new study, which analyzed data between Dec. 14, 2020, and Feb. 28, 2021, from three federal databases, adds to a pool of limited data about the safety and efficacy of the vaccine in pregnant persons. Researchers did not include people who received the Johnson & Johnson vaccine because it received emergency use authorization on Feb. 27, just 1 day before they study’s cutoff.

“Our hope is that these initial data will be reassuring to pregnant people and their health care providers as well as the public, and contribute to increasing vaccination rates,” study author Christine Olson, MD, said in an interview. “While the data are preliminary and will continue to be analyzed as more reports become available, our findings are reassuring.”

For the study, Dr. Olson and colleagues analyzed v-safe survey data, data from those enrolled in the v-safe pregnancy registry, and Vaccine Adverse Event Reporting System (VAERS) reports.

Researchers found that 86% of pregnancies resulted in a live birth, 12.6 % resulted in spontaneous abortions, and 0.1% resulted in stillbirth. They also found that, among the live births, 9.4% were preterm, 3.2% of babies were small for their gestational age, and 2.2% had congenital anomalies.

Researchers also found that injection-site pain, fatigue, and headaches were reported more frequently in pregnant patients than among those who were not pregnant. Among VAERS reports, they found that 70% of adverse events were nonpregnancy specific. Nearly 30% involved pregnancy- or neonatal-specific adverse events. The most frequently reported pregnancy-related events were spontaneous abortions, followed by stillbirths, premature rupture of membranes and vaginal bleeding.

“I think the results are actually quite reassuring as the proportion of the pregnancy outcomes, such as pregnancy loss and health effects to the newborns, are really quite consistent with what we’d expect in the background rate of the population,” Dr. Walensky said in a podcast accompanying the study. “So this study adds to growing evidence confirming that pregnant people develop a robust immune response to COVID-19 vaccination without so far seeing any adverse events to the mom or the fetus.”

Researchers said limitations of the study include the accuracy of self-reported data, and there being limited information on other potential risk factors for adverse pregnancies and neonatal outcomes. They acknowledged that continuous monitoring is needed to look at maternal safety and pregnancy outcomes in earlier stages of pregnancy and during the preconception period.

David Jaspan, DO, chair of the department of obstetrics and gynecology at Einstein Medical Center, Philadelphia, who was not involved with the study, said in an interview that, despite the limitations, the study provides much-needed insight on the vaccine’s safety and efficacy in pregnant patients.

“In December we had no data for any pregnant patient,” Dr. Jaspan said. “And now just 4 short months later, this paper [has data from] at least had 35,000 people. We can’t answer every question, but we have more answers today than we had just 4 months ago.”

Dr. Olson hopes the present data is enough to help inform decision-making of pregnant patients and their health care providers when it comes to deciding to get the COVID-19 vaccination.

The study author and experts interviewed disclosed no relevant financial relationships.

The Pfizer and Moderna COVID-19 vaccines appear to be safe in pregnant patients, according to preliminary findings published in the New England Journal of Medicine.

The Centers for Disease Control and Prevention have said pregnant people have an increased risk of being severely ill from COVID-19; however, this group was excluded from major clinical trials that led up to the current vaccine approvals.

But based on the new findings, Rochelle Walensky, MD, director of the CDC, announced during a White House COVID-19 briefing that the CDC recommends that pregnant people receive the COVID-19 vaccine.

The new study, which analyzed data between Dec. 14, 2020, and Feb. 28, 2021, from three federal databases, adds to a pool of limited data about the safety and efficacy of the vaccine in pregnant persons. Researchers did not include people who received the Johnson & Johnson vaccine because it received emergency use authorization on Feb. 27, just 1 day before they study’s cutoff.

“Our hope is that these initial data will be reassuring to pregnant people and their health care providers as well as the public, and contribute to increasing vaccination rates,” study author Christine Olson, MD, said in an interview. “While the data are preliminary and will continue to be analyzed as more reports become available, our findings are reassuring.”

For the study, Dr. Olson and colleagues analyzed v-safe survey data, data from those enrolled in the v-safe pregnancy registry, and Vaccine Adverse Event Reporting System (VAERS) reports.

Researchers found that 86% of pregnancies resulted in a live birth, 12.6 % resulted in spontaneous abortions, and 0.1% resulted in stillbirth. They also found that, among the live births, 9.4% were preterm, 3.2% of babies were small for their gestational age, and 2.2% had congenital anomalies.

Researchers also found that injection-site pain, fatigue, and headaches were reported more frequently in pregnant patients than among those who were not pregnant. Among VAERS reports, they found that 70% of adverse events were nonpregnancy specific. Nearly 30% involved pregnancy- or neonatal-specific adverse events. The most frequently reported pregnancy-related events were spontaneous abortions, followed by stillbirths, premature rupture of membranes and vaginal bleeding.

“I think the results are actually quite reassuring as the proportion of the pregnancy outcomes, such as pregnancy loss and health effects to the newborns, are really quite consistent with what we’d expect in the background rate of the population,” Dr. Walensky said in a podcast accompanying the study. “So this study adds to growing evidence confirming that pregnant people develop a robust immune response to COVID-19 vaccination without so far seeing any adverse events to the mom or the fetus.”

Researchers said limitations of the study include the accuracy of self-reported data, and there being limited information on other potential risk factors for adverse pregnancies and neonatal outcomes. They acknowledged that continuous monitoring is needed to look at maternal safety and pregnancy outcomes in earlier stages of pregnancy and during the preconception period.

David Jaspan, DO, chair of the department of obstetrics and gynecology at Einstein Medical Center, Philadelphia, who was not involved with the study, said in an interview that, despite the limitations, the study provides much-needed insight on the vaccine’s safety and efficacy in pregnant patients.

“In December we had no data for any pregnant patient,” Dr. Jaspan said. “And now just 4 short months later, this paper [has data from] at least had 35,000 people. We can’t answer every question, but we have more answers today than we had just 4 months ago.”

Dr. Olson hopes the present data is enough to help inform decision-making of pregnant patients and their health care providers when it comes to deciding to get the COVID-19 vaccination.

The study author and experts interviewed disclosed no relevant financial relationships.

The Pfizer and Moderna COVID-19 vaccines appear to be safe in pregnant patients, according to preliminary findings published in the New England Journal of Medicine.

The Centers for Disease Control and Prevention have said pregnant people have an increased risk of being severely ill from COVID-19; however, this group was excluded from major clinical trials that led up to the current vaccine approvals.

But based on the new findings, Rochelle Walensky, MD, director of the CDC, announced during a White House COVID-19 briefing that the CDC recommends that pregnant people receive the COVID-19 vaccine.

The new study, which analyzed data between Dec. 14, 2020, and Feb. 28, 2021, from three federal databases, adds to a pool of limited data about the safety and efficacy of the vaccine in pregnant persons. Researchers did not include people who received the Johnson & Johnson vaccine because it received emergency use authorization on Feb. 27, just 1 day before they study’s cutoff.

“Our hope is that these initial data will be reassuring to pregnant people and their health care providers as well as the public, and contribute to increasing vaccination rates,” study author Christine Olson, MD, said in an interview. “While the data are preliminary and will continue to be analyzed as more reports become available, our findings are reassuring.”

For the study, Dr. Olson and colleagues analyzed v-safe survey data, data from those enrolled in the v-safe pregnancy registry, and Vaccine Adverse Event Reporting System (VAERS) reports.

Researchers found that 86% of pregnancies resulted in a live birth, 12.6 % resulted in spontaneous abortions, and 0.1% resulted in stillbirth. They also found that, among the live births, 9.4% were preterm, 3.2% of babies were small for their gestational age, and 2.2% had congenital anomalies.

Researchers also found that injection-site pain, fatigue, and headaches were reported more frequently in pregnant patients than among those who were not pregnant. Among VAERS reports, they found that 70% of adverse events were nonpregnancy specific. Nearly 30% involved pregnancy- or neonatal-specific adverse events. The most frequently reported pregnancy-related events were spontaneous abortions, followed by stillbirths, premature rupture of membranes and vaginal bleeding.

“I think the results are actually quite reassuring as the proportion of the pregnancy outcomes, such as pregnancy loss and health effects to the newborns, are really quite consistent with what we’d expect in the background rate of the population,” Dr. Walensky said in a podcast accompanying the study. “So this study adds to growing evidence confirming that pregnant people develop a robust immune response to COVID-19 vaccination without so far seeing any adverse events to the mom or the fetus.”

Researchers said limitations of the study include the accuracy of self-reported data, and there being limited information on other potential risk factors for adverse pregnancies and neonatal outcomes. They acknowledged that continuous monitoring is needed to look at maternal safety and pregnancy outcomes in earlier stages of pregnancy and during the preconception period.

David Jaspan, DO, chair of the department of obstetrics and gynecology at Einstein Medical Center, Philadelphia, who was not involved with the study, said in an interview that, despite the limitations, the study provides much-needed insight on the vaccine’s safety and efficacy in pregnant patients.

“In December we had no data for any pregnant patient,” Dr. Jaspan said. “And now just 4 short months later, this paper [has data from] at least had 35,000 people. We can’t answer every question, but we have more answers today than we had just 4 months ago.”

Dr. Olson hopes the present data is enough to help inform decision-making of pregnant patients and their health care providers when it comes to deciding to get the COVID-19 vaccination.

The study author and experts interviewed disclosed no relevant financial relationships.

The Food and Drug Administration granted an accelerated approval April 24, 2021, for a new drug for use in patients with relapsed/refractory diffuse large B-cell lymphomas (DLBCL) who have tried at least two prior systemic therapies.

The new product, loncastuximab tesirine-lpyl (Zynlonta, ADC Therapeutics), is the first and only CD19-targeted antibody-drug conjugate approved for this disease.

DLBCL is the most common type of non-Hodgkin lymphoma in the United States, but the indication also includes DLBCL not otherwise specified, DLBCL arising from low grade lymphoma, and high-grade B-cell lymphoma.

“There is a significant unmet need for treatment options for patients with [relapsed or refractory] DLBCL, including those who have been heavily pretreated and have difficult-to-treat disease,” Paolo F. Caimi, MD, University Hospitals Cleveland Medical Center and Case Comprehensive Cancer Center, Case Western Reserve University, Cleveland, said in a company press release.

The company also cited data from previous clinical trials showing that more than 40% of first-line DLBCL treatments fail, and that these patients have a poor prognosis, worsening with each line of therapy that is tried.
 

Accelerated approval based on ORR

The accelerated approval was based on overall response rate data from the single-arm LOTIS-2 trial. All patients received the new drug, administered as a 30-minute infusion once every 3 weeks for 1 year.

The trial was conducted in 145 patients with relapsed/refractory DLBCL who had already tried at least two lines of systemic therapy. Dr. Caimi noted that this included patients who had been heavily pretreated, as the population included patients who previously received stem cell transplant or chimeric antigen receptor T-cell therapy.

The ORR was 48.3% (70/145 patients), which included a complete response rate of 24.1% (35/145 patients) and a partial response rate of 24.1% (35/145 patients).

Patients had a median time to response of 1.3 months and the median duration of response for the 70 responders was 10.3 months.

“Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial,” the company noted.

A phase 3 confirmatory is underway: the LOTIS 5 trial (NCT04384484) compares the combination of loncastuximab tesirine and rituximab versus chemoimmunotherapy in patients with relapsed/refractory DLBCL.

The company also noted that in a pooled safety population the most common adverse reactions (≥20%) were thrombocytopenia, an increase in levels of the liver enzyme gamma-glutamyltransferase, neutropenia, anemia, hyperglycemia, transaminase elevation, fatigue, hypoalbuminemia, rash, edema, nausea, and musculoskeletal pain.

In the LOTIS-2 trial, the most common (≥10%) grade 3 or higher treatment-emergent adverse events were neutropenia (26.2%), thrombocytopenia (17.9%), GGT increase (17.2%) and anemia (10.3%).

Permanent treatment discontinuation as the result of an adverse reaction occurred in 19% of patients, and these included a GGT increase, edema, and effusion.

Dose reductions because of an adverse reaction occurred in 8% of patients, and most were the result of a GGT increase. Dosage interruptions because of an adverse reaction occurred in 49% of patients, and these included a GGT increase, neutropenia, thrombocytopenia, and edema.
 

Warnings on effusions, infections, and skin reactions

The product carries a warning that serious effusion and edema has been reported. Grade 3 edema occurred in 3% (primarily peripheral edema or ascites), grade 3 pleural effusion occurred in 3%, and grade 3 or 4 pericardial effusion occurred in 1%.

Prescribers are recommended to monitor patients for new or worsening edema or effusions, and to consider diagnostic imaging in patients who develop symptoms of pleural effusion or pericardial effusion, such as new or worsened dyspnea, chest pain, and/or ascites such as swelling in the abdomen and bloating.

The product also carries a warning about fatal and serious infections, including opportunistic infections, and serious cutaneous reactions, including photosensitivity reaction, rash (including exfoliative and maculopapular), and erythema.

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

The Food and Drug Administration granted an accelerated approval April 24, 2021, for a new drug for use in patients with relapsed/refractory diffuse large B-cell lymphomas (DLBCL) who have tried at least two prior systemic therapies.

The new product, loncastuximab tesirine-lpyl (Zynlonta, ADC Therapeutics), is the first and only CD19-targeted antibody-drug conjugate approved for this disease.

DLBCL is the most common type of non-Hodgkin lymphoma in the United States, but the indication also includes DLBCL not otherwise specified, DLBCL arising from low grade lymphoma, and high-grade B-cell lymphoma.

“There is a significant unmet need for treatment options for patients with [relapsed or refractory] DLBCL, including those who have been heavily pretreated and have difficult-to-treat disease,” Paolo F. Caimi, MD, University Hospitals Cleveland Medical Center and Case Comprehensive Cancer Center, Case Western Reserve University, Cleveland, said in a company press release.

The company also cited data from previous clinical trials showing that more than 40% of first-line DLBCL treatments fail, and that these patients have a poor prognosis, worsening with each line of therapy that is tried.
 

Accelerated approval based on ORR

The accelerated approval was based on overall response rate data from the single-arm LOTIS-2 trial. All patients received the new drug, administered as a 30-minute infusion once every 3 weeks for 1 year.

The trial was conducted in 145 patients with relapsed/refractory DLBCL who had already tried at least two lines of systemic therapy. Dr. Caimi noted that this included patients who had been heavily pretreated, as the population included patients who previously received stem cell transplant or chimeric antigen receptor T-cell therapy.

The ORR was 48.3% (70/145 patients), which included a complete response rate of 24.1% (35/145 patients) and a partial response rate of 24.1% (35/145 patients).

Patients had a median time to response of 1.3 months and the median duration of response for the 70 responders was 10.3 months.

“Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial,” the company noted.

A phase 3 confirmatory is underway: the LOTIS 5 trial (NCT04384484) compares the combination of loncastuximab tesirine and rituximab versus chemoimmunotherapy in patients with relapsed/refractory DLBCL.

The company also noted that in a pooled safety population the most common adverse reactions (≥20%) were thrombocytopenia, an increase in levels of the liver enzyme gamma-glutamyltransferase, neutropenia, anemia, hyperglycemia, transaminase elevation, fatigue, hypoalbuminemia, rash, edema, nausea, and musculoskeletal pain.

In the LOTIS-2 trial, the most common (≥10%) grade 3 or higher treatment-emergent adverse events were neutropenia (26.2%), thrombocytopenia (17.9%), GGT increase (17.2%) and anemia (10.3%).

Permanent treatment discontinuation as the result of an adverse reaction occurred in 19% of patients, and these included a GGT increase, edema, and effusion.

Dose reductions because of an adverse reaction occurred in 8% of patients, and most were the result of a GGT increase. Dosage interruptions because of an adverse reaction occurred in 49% of patients, and these included a GGT increase, neutropenia, thrombocytopenia, and edema.
 

Warnings on effusions, infections, and skin reactions

The product carries a warning that serious effusion and edema has been reported. Grade 3 edema occurred in 3% (primarily peripheral edema or ascites), grade 3 pleural effusion occurred in 3%, and grade 3 or 4 pericardial effusion occurred in 1%.

Prescribers are recommended to monitor patients for new or worsening edema or effusions, and to consider diagnostic imaging in patients who develop symptoms of pleural effusion or pericardial effusion, such as new or worsened dyspnea, chest pain, and/or ascites such as swelling in the abdomen and bloating.

The product also carries a warning about fatal and serious infections, including opportunistic infections, and serious cutaneous reactions, including photosensitivity reaction, rash (including exfoliative and maculopapular), and erythema.

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

The Food and Drug Administration granted an accelerated approval April 24, 2021, for a new drug for use in patients with relapsed/refractory diffuse large B-cell lymphomas (DLBCL) who have tried at least two prior systemic therapies.

The new product, loncastuximab tesirine-lpyl (Zynlonta, ADC Therapeutics), is the first and only CD19-targeted antibody-drug conjugate approved for this disease.

DLBCL is the most common type of non-Hodgkin lymphoma in the United States, but the indication also includes DLBCL not otherwise specified, DLBCL arising from low grade lymphoma, and high-grade B-cell lymphoma.

“There is a significant unmet need for treatment options for patients with [relapsed or refractory] DLBCL, including those who have been heavily pretreated and have difficult-to-treat disease,” Paolo F. Caimi, MD, University Hospitals Cleveland Medical Center and Case Comprehensive Cancer Center, Case Western Reserve University, Cleveland, said in a company press release.

The company also cited data from previous clinical trials showing that more than 40% of first-line DLBCL treatments fail, and that these patients have a poor prognosis, worsening with each line of therapy that is tried.
 

Accelerated approval based on ORR

The accelerated approval was based on overall response rate data from the single-arm LOTIS-2 trial. All patients received the new drug, administered as a 30-minute infusion once every 3 weeks for 1 year.

The trial was conducted in 145 patients with relapsed/refractory DLBCL who had already tried at least two lines of systemic therapy. Dr. Caimi noted that this included patients who had been heavily pretreated, as the population included patients who previously received stem cell transplant or chimeric antigen receptor T-cell therapy.

The ORR was 48.3% (70/145 patients), which included a complete response rate of 24.1% (35/145 patients) and a partial response rate of 24.1% (35/145 patients).

Patients had a median time to response of 1.3 months and the median duration of response for the 70 responders was 10.3 months.

“Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial,” the company noted.

A phase 3 confirmatory is underway: the LOTIS 5 trial (NCT04384484) compares the combination of loncastuximab tesirine and rituximab versus chemoimmunotherapy in patients with relapsed/refractory DLBCL.

The company also noted that in a pooled safety population the most common adverse reactions (≥20%) were thrombocytopenia, an increase in levels of the liver enzyme gamma-glutamyltransferase, neutropenia, anemia, hyperglycemia, transaminase elevation, fatigue, hypoalbuminemia, rash, edema, nausea, and musculoskeletal pain.

In the LOTIS-2 trial, the most common (≥10%) grade 3 or higher treatment-emergent adverse events were neutropenia (26.2%), thrombocytopenia (17.9%), GGT increase (17.2%) and anemia (10.3%).

Permanent treatment discontinuation as the result of an adverse reaction occurred in 19% of patients, and these included a GGT increase, edema, and effusion.

Dose reductions because of an adverse reaction occurred in 8% of patients, and most were the result of a GGT increase. Dosage interruptions because of an adverse reaction occurred in 49% of patients, and these included a GGT increase, neutropenia, thrombocytopenia, and edema.
 

Warnings on effusions, infections, and skin reactions

The product carries a warning that serious effusion and edema has been reported. Grade 3 edema occurred in 3% (primarily peripheral edema or ascites), grade 3 pleural effusion occurred in 3%, and grade 3 or 4 pericardial effusion occurred in 1%.

Prescribers are recommended to monitor patients for new or worsening edema or effusions, and to consider diagnostic imaging in patients who develop symptoms of pleural effusion or pericardial effusion, such as new or worsened dyspnea, chest pain, and/or ascites such as swelling in the abdomen and bloating.

The product also carries a warning about fatal and serious infections, including opportunistic infections, and serious cutaneous reactions, including photosensitivity reaction, rash (including exfoliative and maculopapular), and erythema.

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

Acute kidney injury (AKI) is a frequent complication among patients hospitalized for COVID-19, with incidence rates of 39% and 52% in two independent, European case series presented recently at the International Society of Nephrology: 2021 World Congress. Many of the cases progressed to more severe, stage 3 AKI. Factors linked with incident AKI in the two reports included use of mechanical ventilation, vasopressors, or diuretics, and elevations in inflammatory markers.

Mohammed Haneefa Nizamudeen/Getty Images

The new findings confirm several U.S. reports published during the past year. In those reports, roughly a third of patients hospitalized for COVID-19 developed AKI during their hospital stay, said Jay L. Koyner, MD, during another renal conference, the National Kidney Foundation 2021 Spring Clinical Meetings.

Experience has shown it’s bad news when hospitalized COVID-19 patients develop AKI, which can prove fatal or can lead to the development or worsening of chronic kidney disease (CKD), which in some cases rapidly progresses to end-stage disease.
 

COVID-19 giving nephrologists an opportunity to improve AKI care

“COVID is giving us an opportunity to do a better job of taking care of patients who develop AKI, which is something that nephrologists have not often excelled at doing,” said Dr. Koyner, professor and director of the nephrology ICU at the University of Chicago.

“Many studies will look at how we can manage COVID-19 patients better after they develop AKI, because I suspect a large number of these patients will wind up with CKD,” Dr. Koyner said during his talk.

He cited several lessons from reports of AKI that occurs in patients hospitalized for COVID-19:

• Preexisting CKD, , and severe COVID-19 appear to be risk factors for developing COVID-related AKI.
• Patients who develop AKI during acutely severe COVID-19 may have slightly worse outcomes than patients without COVID-19 who develop AKI.
• Certain genetic susceptibilities may play a role in developing COVID-19–related AKI.
• Routine follow-up of AKI is generally inadequate and is not standardized, whether AKI develops while ill with COVID-19 or in other settings.

The most encouraging AKI takeaway from COVID-19’s first year is that its incidence among patients hospitalized with COVID-19 appears to have dropped from very high rates early on, possibly because of more routine use of steroids for critically ill patients with COVID-19 and a reduction in the use of ventilators, Dr. Koyner suggested.
 

In-hospital diuretic treatment links with AKI

One of the World Congress of Nephrology reports involved 1,248 patients admitted with confirmed COVID-19 at two tertiary care hospitals in London during March–May 2020. The average age of the patients was 69 years, 59% were men, and 17% had CKD at admission, as determined on the basis of estimated glomerular filtration rate <60 mL/min per 1.73 m².

During hospitalization, 487 patients (39%) developed AKI, including 175 (14%) with stage 3 AKI and 109 (9%) who required renal replacement therapy (dialysis or kidney transplant). The incidence of AKI peaked 5 weeks after COVID-19 admission, Paul Jewell and associates from King’s College Hospital, London, reported in a poster.

Multivariate analysis identified several demographic and clinical variables that were significantly linked with an increased risk of developing AKI: male sex (which boosted risk by 55%), Black race (79% higher risk), CKD at admission (triple the risk), being hypertensive on admission (73% higher risk), and being administered diuretics during hospitalization (69% higher risk).

The findings of a risk linked with diuretic use “supports the cautious use of diuretics in patients hospitalized with COVID-19, especially in the presence of background renal impairment,” the authors said.

For patients with incident AKI, the 30-day mortality rate was significantly increased; mortality was 59% higher among patients who developed stage 1 AKI and was roughly triple among patients who developed stage 2 or 3 AKI.
 

Second report links ventilation, vasopressors with worse AKI

A separate report from clinicians at Charité Hospital, Berlin, retrospectively analyzed 223 patients admitted with symptomatic COVID-19 to three Charité sites during March–June 2020. During hospitalization, 117 patients (52%) developed AKI, including 70 (31%) with stage 3 disease; 67 (30%) required renal replacement therapy. Half the patients with stage 3 AKI required ICU admission.

Compared with patients with less severe AKI, patients who developed stage 3 AKI were more often male, older, and had a higher body mass index.

In a multivariate model, compared with patients who developed less severe AKI, those who developed stage 3 disease also were significantly more likely to have received mechanical ventilation or vasopressor drugs and were more likely to have increased levels of leukocytes or procalcitonin, two inflammatory markers, Jan-Hendrink B. Hardenburg, MD, a Charité nephrologist, and associates reported in a poster at the meeting.

Mechanical ventilation was linked with a sixfold higher rate of stage 3 AKI, and treatment with vasopressor drugs was linked with a threefold higher rate. Elevations in procalcitonin or leukocyte levels were linked with about 60% increases in rates of stage 3 AKI. For both of these risk factors, temporal relationships were tighter; increases in both values appeared just before onset of stage 3 disease.

Dr. Joyner has been a speaker on behalf of NXStage Medical; a consultant to Astute Medical, Baxter, Mallinckrodt, Pfizer, and Sphingotec; and he has received research funding from Astute, Bioporto, NxStage, and Satellite Healthcare. Mr. Jewell and Dr. Hardenburg disclosed no relevant financial relationships.

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

Acute kidney injury (AKI) is a frequent complication among patients hospitalized for COVID-19, with incidence rates of 39% and 52% in two independent, European case series presented recently at the International Society of Nephrology: 2021 World Congress. Many of the cases progressed to more severe, stage 3 AKI. Factors linked with incident AKI in the two reports included use of mechanical ventilation, vasopressors, or diuretics, and elevations in inflammatory markers.

Mohammed Haneefa Nizamudeen/Getty Images

The new findings confirm several U.S. reports published during the past year. In those reports, roughly a third of patients hospitalized for COVID-19 developed AKI during their hospital stay, said Jay L. Koyner, MD, during another renal conference, the National Kidney Foundation 2021 Spring Clinical Meetings.

Experience has shown it’s bad news when hospitalized COVID-19 patients develop AKI, which can prove fatal or can lead to the development or worsening of chronic kidney disease (CKD), which in some cases rapidly progresses to end-stage disease.
 

COVID-19 giving nephrologists an opportunity to improve AKI care

“COVID is giving us an opportunity to do a better job of taking care of patients who develop AKI, which is something that nephrologists have not often excelled at doing,” said Dr. Koyner, professor and director of the nephrology ICU at the University of Chicago.

“Many studies will look at how we can manage COVID-19 patients better after they develop AKI, because I suspect a large number of these patients will wind up with CKD,” Dr. Koyner said during his talk.

He cited several lessons from reports of AKI that occurs in patients hospitalized for COVID-19:

• Preexisting CKD, , and severe COVID-19 appear to be risk factors for developing COVID-related AKI.
• Patients who develop AKI during acutely severe COVID-19 may have slightly worse outcomes than patients without COVID-19 who develop AKI.
• Certain genetic susceptibilities may play a role in developing COVID-19–related AKI.
• Routine follow-up of AKI is generally inadequate and is not standardized, whether AKI develops while ill with COVID-19 or in other settings.

The most encouraging AKI takeaway from COVID-19’s first year is that its incidence among patients hospitalized with COVID-19 appears to have dropped from very high rates early on, possibly because of more routine use of steroids for critically ill patients with COVID-19 and a reduction in the use of ventilators, Dr. Koyner suggested.
 

In-hospital diuretic treatment links with AKI

One of the World Congress of Nephrology reports involved 1,248 patients admitted with confirmed COVID-19 at two tertiary care hospitals in London during March–May 2020. The average age of the patients was 69 years, 59% were men, and 17% had CKD at admission, as determined on the basis of estimated glomerular filtration rate <60 mL/min per 1.73 m².

During hospitalization, 487 patients (39%) developed AKI, including 175 (14%) with stage 3 AKI and 109 (9%) who required renal replacement therapy (dialysis or kidney transplant). The incidence of AKI peaked 5 weeks after COVID-19 admission, Paul Jewell and associates from King’s College Hospital, London, reported in a poster.

Multivariate analysis identified several demographic and clinical variables that were significantly linked with an increased risk of developing AKI: male sex (which boosted risk by 55%), Black race (79% higher risk), CKD at admission (triple the risk), being hypertensive on admission (73% higher risk), and being administered diuretics during hospitalization (69% higher risk).

The findings of a risk linked with diuretic use “supports the cautious use of diuretics in patients hospitalized with COVID-19, especially in the presence of background renal impairment,” the authors said.

For patients with incident AKI, the 30-day mortality rate was significantly increased; mortality was 59% higher among patients who developed stage 1 AKI and was roughly triple among patients who developed stage 2 or 3 AKI.
 

Second report links ventilation, vasopressors with worse AKI

A separate report from clinicians at Charité Hospital, Berlin, retrospectively analyzed 223 patients admitted with symptomatic COVID-19 to three Charité sites during March–June 2020. During hospitalization, 117 patients (52%) developed AKI, including 70 (31%) with stage 3 disease; 67 (30%) required renal replacement therapy. Half the patients with stage 3 AKI required ICU admission.

Compared with patients with less severe AKI, patients who developed stage 3 AKI were more often male, older, and had a higher body mass index.

In a multivariate model, compared with patients who developed less severe AKI, those who developed stage 3 disease also were significantly more likely to have received mechanical ventilation or vasopressor drugs and were more likely to have increased levels of leukocytes or procalcitonin, two inflammatory markers, Jan-Hendrink B. Hardenburg, MD, a Charité nephrologist, and associates reported in a poster at the meeting.

Mechanical ventilation was linked with a sixfold higher rate of stage 3 AKI, and treatment with vasopressor drugs was linked with a threefold higher rate. Elevations in procalcitonin or leukocyte levels were linked with about 60% increases in rates of stage 3 AKI. For both of these risk factors, temporal relationships were tighter; increases in both values appeared just before onset of stage 3 disease.

Dr. Joyner has been a speaker on behalf of NXStage Medical; a consultant to Astute Medical, Baxter, Mallinckrodt, Pfizer, and Sphingotec; and he has received research funding from Astute, Bioporto, NxStage, and Satellite Healthcare. Mr. Jewell and Dr. Hardenburg disclosed no relevant financial relationships.

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

Acute kidney injury (AKI) is a frequent complication among patients hospitalized for COVID-19, with incidence rates of 39% and 52% in two independent, European case series presented recently at the International Society of Nephrology: 2021 World Congress. Many of the cases progressed to more severe, stage 3 AKI. Factors linked with incident AKI in the two reports included use of mechanical ventilation, vasopressors, or diuretics, and elevations in inflammatory markers.

Mohammed Haneefa Nizamudeen/Getty Images

The new findings confirm several U.S. reports published during the past year. In those reports, roughly a third of patients hospitalized for COVID-19 developed AKI during their hospital stay, said Jay L. Koyner, MD, during another renal conference, the National Kidney Foundation 2021 Spring Clinical Meetings.

Experience has shown it’s bad news when hospitalized COVID-19 patients develop AKI, which can prove fatal or can lead to the development or worsening of chronic kidney disease (CKD), which in some cases rapidly progresses to end-stage disease.
 

COVID-19 giving nephrologists an opportunity to improve AKI care

“COVID is giving us an opportunity to do a better job of taking care of patients who develop AKI, which is something that nephrologists have not often excelled at doing,” said Dr. Koyner, professor and director of the nephrology ICU at the University of Chicago.

“Many studies will look at how we can manage COVID-19 patients better after they develop AKI, because I suspect a large number of these patients will wind up with CKD,” Dr. Koyner said during his talk.

He cited several lessons from reports of AKI that occurs in patients hospitalized for COVID-19:

• Preexisting CKD, , and severe COVID-19 appear to be risk factors for developing COVID-related AKI.
• Patients who develop AKI during acutely severe COVID-19 may have slightly worse outcomes than patients without COVID-19 who develop AKI.
• Certain genetic susceptibilities may play a role in developing COVID-19–related AKI.
• Routine follow-up of AKI is generally inadequate and is not standardized, whether AKI develops while ill with COVID-19 or in other settings.

The most encouraging AKI takeaway from COVID-19’s first year is that its incidence among patients hospitalized with COVID-19 appears to have dropped from very high rates early on, possibly because of more routine use of steroids for critically ill patients with COVID-19 and a reduction in the use of ventilators, Dr. Koyner suggested.
 

In-hospital diuretic treatment links with AKI

One of the World Congress of Nephrology reports involved 1,248 patients admitted with confirmed COVID-19 at two tertiary care hospitals in London during March–May 2020. The average age of the patients was 69 years, 59% were men, and 17% had CKD at admission, as determined on the basis of estimated glomerular filtration rate <60 mL/min per 1.73 m².

During hospitalization, 487 patients (39%) developed AKI, including 175 (14%) with stage 3 AKI and 109 (9%) who required renal replacement therapy (dialysis or kidney transplant). The incidence of AKI peaked 5 weeks after COVID-19 admission, Paul Jewell and associates from King’s College Hospital, London, reported in a poster.

Multivariate analysis identified several demographic and clinical variables that were significantly linked with an increased risk of developing AKI: male sex (which boosted risk by 55%), Black race (79% higher risk), CKD at admission (triple the risk), being hypertensive on admission (73% higher risk), and being administered diuretics during hospitalization (69% higher risk).

The findings of a risk linked with diuretic use “supports the cautious use of diuretics in patients hospitalized with COVID-19, especially in the presence of background renal impairment,” the authors said.

For patients with incident AKI, the 30-day mortality rate was significantly increased; mortality was 59% higher among patients who developed stage 1 AKI and was roughly triple among patients who developed stage 2 or 3 AKI.
 

Second report links ventilation, vasopressors with worse AKI

A separate report from clinicians at Charité Hospital, Berlin, retrospectively analyzed 223 patients admitted with symptomatic COVID-19 to three Charité sites during March–June 2020. During hospitalization, 117 patients (52%) developed AKI, including 70 (31%) with stage 3 disease; 67 (30%) required renal replacement therapy. Half the patients with stage 3 AKI required ICU admission.

Compared with patients with less severe AKI, patients who developed stage 3 AKI were more often male, older, and had a higher body mass index.

In a multivariate model, compared with patients who developed less severe AKI, those who developed stage 3 disease also were significantly more likely to have received mechanical ventilation or vasopressor drugs and were more likely to have increased levels of leukocytes or procalcitonin, two inflammatory markers, Jan-Hendrink B. Hardenburg, MD, a Charité nephrologist, and associates reported in a poster at the meeting.

Mechanical ventilation was linked with a sixfold higher rate of stage 3 AKI, and treatment with vasopressor drugs was linked with a threefold higher rate. Elevations in procalcitonin or leukocyte levels were linked with about 60% increases in rates of stage 3 AKI. For both of these risk factors, temporal relationships were tighter; increases in both values appeared just before onset of stage 3 disease.

Dr. Joyner has been a speaker on behalf of NXStage Medical; a consultant to Astute Medical, Baxter, Mallinckrodt, Pfizer, and Sphingotec; and he has received research funding from Astute, Bioporto, NxStage, and Satellite Healthcare. Mr. Jewell and Dr. Hardenburg disclosed no relevant financial relationships.

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

One consequence of the ongoing opioid epidemic in the United States may be an increase in the number of hemorrhagic strokes caused by infective endocarditis, research suggests.

Intravenous drug use (IVDU) can cause this bacterial infection of the heart. In a single-center study, infective endocarditis was associated with an increase in the risk for hemorrhagic stroke as well as an increase in health care use and costs.

“Patients who are known IV drug users who have endocarditis should be more carefully screened for symptoms of cardiovascular disease,” Shahid M. Nimjee, MD, PhD, associate professor of neurosurgery and surgical director of the Comprehensive Stroke Center at the Ohio State University Wexner Medical Center, Columbus, said in a press release.

The findings were presented at the International Stroke Conference sponsored by the American Heart Association.

In the United States, 47,000 patients are treated in the hospital for endocarditis each year. Endocarditis increases the risk for stroke, which can entail significant morbidity and mortality, the authors noted.

IVDU is a risk factor for endocarditis. In the context of the opioid epidemic, Dr. Nimjee and colleagues sought to compare the risk for stroke among patients with endocarditis from IVDU with the risk among patients with endocarditis from other causes.

They retrospectively studied patients who had undergone treatment for infective endocarditis at Wexner Medical Center between Jan. 1, 2014, and July 1, 2018. They examined patients’ concomitant intravenous drug abuse and evaluated demographics, risk factors, and associated costs.
 

Dramatic increase

In all, 351 patients met the study’s inclusion criteria, and 170 (48%) had a history of IVDU-associated endocarditis. The incidence of patients with IVDU-associated endocarditis increased 630% from 2014 to 2018.

The prevalence of overall intracranial hemorrhage was increased among patients with IVDU, compared with those without (25.9% vs. 13.9%; P = .005).

This increase in prevalence included increases in intraparenchymal hemorrhage (12.4% vs. 5.1%; P = .012), subarachnoid hemorrhage (17.6% vs. 4.4%; P = .0001), and cerebral microbleeds (14.1% vs. 7.2%; P = .022).

IVDU also was associated with an increase in prevalence of infectious intracranial aneurysm (10.6% vs. 1.8%; P = .0001) and brain abscess (4.7% vs. 1.1%; P = .025).

Compared with patients with endocarditis from other causes, significantly higher numbers of patients with IVDU-associated endocarditis were homeless (5.9% vs. 1.1%; P = .014), uninsured (10.0% vs. 2.8%; P = .005), and unemployed (75.9% vs. 31.7%; P = .0001).

Medical costs were more than twice as high among patients with endocarditis from IVDU than among those with endocarditis from other causes. The difference in health care costs during admission per patient was more than $100,000.

“The wider societal impact of the opioid epidemic is not well understood,” Dr. Nimjee said in the press release. “Our research suggests that the impact of the opioid epidemic is far-reaching and contributes to increased costs in the criminal justice, health care systems, and the workplace. The increased costs can be particularly substantial for stroke care.”
 

Nationwide data desirable

“Past publications from the U.S. have shown an increase in incidence of IVDU-related endocarditis, and the current publication emphasizes this worrying trend,” Manuel Bolognese, MD, head of the stroke center at the Lucerne (Switzerland) Cantonal Hospital, said in an interview. “The higher degree of hemorrhagic strokes and brain abscesses as further complications is alarming as well and shows that IVDU-related endocarditis is becoming a more and more relevant medical problem in the U.S., with high morbidity and mortality.”

The study period is long enough to show a clear trend of increasing incidence of IVDU-related endocarditis, Dr. Bolognese said. The study’s biggest weaknesses are its retrospective design and restriction to a single center.

“Without knowing the prevalence of drug abuse and the socioeconomical situation in Columbus, it is difficult to generalize these findings to other regions in the U.S.A. or even abroad,” he said.

Also, the abstract does not provide some essential information, said Dr. Bolognese. It would be important to know which valve was affected in each patient, which bacteria were identified, whether patients also used nonopioid drugs, and what each patient’s immune status was.

A lack of sterile material such as syringes could explain the apparent association between IVDU-associated endocarditis and low socioeconomic status, said Dr. Bolognese. Delayed presentation to medical institutions because of a lack of insurance could have led to a more complicated course.

“It would be interesting to see numbers from a broader spectrum in a nationwide registry,” said Dr. Bolognese. “It might be worth studying interventions to improve the hygienic aspects (like supply of sterile material, especially in the most vulnerable groups, like homeless people) or to provide easier access to emergency health care despite lack of insurance, which could decrease the incidence of IVDU.”

Dr. Nimjee and Dr. Bolognese disclosed no relevant financial relationships.

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

One consequence of the ongoing opioid epidemic in the United States may be an increase in the number of hemorrhagic strokes caused by infective endocarditis, research suggests.

Intravenous drug use (IVDU) can cause this bacterial infection of the heart. In a single-center study, infective endocarditis was associated with an increase in the risk for hemorrhagic stroke as well as an increase in health care use and costs.

“Patients who are known IV drug users who have endocarditis should be more carefully screened for symptoms of cardiovascular disease,” Shahid M. Nimjee, MD, PhD, associate professor of neurosurgery and surgical director of the Comprehensive Stroke Center at the Ohio State University Wexner Medical Center, Columbus, said in a press release.

The findings were presented at the International Stroke Conference sponsored by the American Heart Association.

In the United States, 47,000 patients are treated in the hospital for endocarditis each year. Endocarditis increases the risk for stroke, which can entail significant morbidity and mortality, the authors noted.

IVDU is a risk factor for endocarditis. In the context of the opioid epidemic, Dr. Nimjee and colleagues sought to compare the risk for stroke among patients with endocarditis from IVDU with the risk among patients with endocarditis from other causes.

They retrospectively studied patients who had undergone treatment for infective endocarditis at Wexner Medical Center between Jan. 1, 2014, and July 1, 2018. They examined patients’ concomitant intravenous drug abuse and evaluated demographics, risk factors, and associated costs.
 

Dramatic increase

In all, 351 patients met the study’s inclusion criteria, and 170 (48%) had a history of IVDU-associated endocarditis. The incidence of patients with IVDU-associated endocarditis increased 630% from 2014 to 2018.

The prevalence of overall intracranial hemorrhage was increased among patients with IVDU, compared with those without (25.9% vs. 13.9%; P = .005).

This increase in prevalence included increases in intraparenchymal hemorrhage (12.4% vs. 5.1%; P = .012), subarachnoid hemorrhage (17.6% vs. 4.4%; P = .0001), and cerebral microbleeds (14.1% vs. 7.2%; P = .022).

IVDU also was associated with an increase in prevalence of infectious intracranial aneurysm (10.6% vs. 1.8%; P = .0001) and brain abscess (4.7% vs. 1.1%; P = .025).

Compared with patients with endocarditis from other causes, significantly higher numbers of patients with IVDU-associated endocarditis were homeless (5.9% vs. 1.1%; P = .014), uninsured (10.0% vs. 2.8%; P = .005), and unemployed (75.9% vs. 31.7%; P = .0001).

Medical costs were more than twice as high among patients with endocarditis from IVDU than among those with endocarditis from other causes. The difference in health care costs during admission per patient was more than $100,000.

“The wider societal impact of the opioid epidemic is not well understood,” Dr. Nimjee said in the press release. “Our research suggests that the impact of the opioid epidemic is far-reaching and contributes to increased costs in the criminal justice, health care systems, and the workplace. The increased costs can be particularly substantial for stroke care.”
 

Nationwide data desirable

“Past publications from the U.S. have shown an increase in incidence of IVDU-related endocarditis, and the current publication emphasizes this worrying trend,” Manuel Bolognese, MD, head of the stroke center at the Lucerne (Switzerland) Cantonal Hospital, said in an interview. “The higher degree of hemorrhagic strokes and brain abscesses as further complications is alarming as well and shows that IVDU-related endocarditis is becoming a more and more relevant medical problem in the U.S., with high morbidity and mortality.”

The study period is long enough to show a clear trend of increasing incidence of IVDU-related endocarditis, Dr. Bolognese said. The study’s biggest weaknesses are its retrospective design and restriction to a single center.

“Without knowing the prevalence of drug abuse and the socioeconomical situation in Columbus, it is difficult to generalize these findings to other regions in the U.S.A. or even abroad,” he said.

Also, the abstract does not provide some essential information, said Dr. Bolognese. It would be important to know which valve was affected in each patient, which bacteria were identified, whether patients also used nonopioid drugs, and what each patient’s immune status was.

A lack of sterile material such as syringes could explain the apparent association between IVDU-associated endocarditis and low socioeconomic status, said Dr. Bolognese. Delayed presentation to medical institutions because of a lack of insurance could have led to a more complicated course.

“It would be interesting to see numbers from a broader spectrum in a nationwide registry,” said Dr. Bolognese. “It might be worth studying interventions to improve the hygienic aspects (like supply of sterile material, especially in the most vulnerable groups, like homeless people) or to provide easier access to emergency health care despite lack of insurance, which could decrease the incidence of IVDU.”

Dr. Nimjee and Dr. Bolognese disclosed no relevant financial relationships.

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

One consequence of the ongoing opioid epidemic in the United States may be an increase in the number of hemorrhagic strokes caused by infective endocarditis, research suggests.

Intravenous drug use (IVDU) can cause this bacterial infection of the heart. In a single-center study, infective endocarditis was associated with an increase in the risk for hemorrhagic stroke as well as an increase in health care use and costs.

“Patients who are known IV drug users who have endocarditis should be more carefully screened for symptoms of cardiovascular disease,” Shahid M. Nimjee, MD, PhD, associate professor of neurosurgery and surgical director of the Comprehensive Stroke Center at the Ohio State University Wexner Medical Center, Columbus, said in a press release.

The findings were presented at the International Stroke Conference sponsored by the American Heart Association.

In the United States, 47,000 patients are treated in the hospital for endocarditis each year. Endocarditis increases the risk for stroke, which can entail significant morbidity and mortality, the authors noted.

IVDU is a risk factor for endocarditis. In the context of the opioid epidemic, Dr. Nimjee and colleagues sought to compare the risk for stroke among patients with endocarditis from IVDU with the risk among patients with endocarditis from other causes.

They retrospectively studied patients who had undergone treatment for infective endocarditis at Wexner Medical Center between Jan. 1, 2014, and July 1, 2018. They examined patients’ concomitant intravenous drug abuse and evaluated demographics, risk factors, and associated costs.
 

Dramatic increase

In all, 351 patients met the study’s inclusion criteria, and 170 (48%) had a history of IVDU-associated endocarditis. The incidence of patients with IVDU-associated endocarditis increased 630% from 2014 to 2018.

The prevalence of overall intracranial hemorrhage was increased among patients with IVDU, compared with those without (25.9% vs. 13.9%; P = .005).

This increase in prevalence included increases in intraparenchymal hemorrhage (12.4% vs. 5.1%; P = .012), subarachnoid hemorrhage (17.6% vs. 4.4%; P = .0001), and cerebral microbleeds (14.1% vs. 7.2%; P = .022).

IVDU also was associated with an increase in prevalence of infectious intracranial aneurysm (10.6% vs. 1.8%; P = .0001) and brain abscess (4.7% vs. 1.1%; P = .025).

Compared with patients with endocarditis from other causes, significantly higher numbers of patients with IVDU-associated endocarditis were homeless (5.9% vs. 1.1%; P = .014), uninsured (10.0% vs. 2.8%; P = .005), and unemployed (75.9% vs. 31.7%; P = .0001).

Medical costs were more than twice as high among patients with endocarditis from IVDU than among those with endocarditis from other causes. The difference in health care costs during admission per patient was more than $100,000.

“The wider societal impact of the opioid epidemic is not well understood,” Dr. Nimjee said in the press release. “Our research suggests that the impact of the opioid epidemic is far-reaching and contributes to increased costs in the criminal justice, health care systems, and the workplace. The increased costs can be particularly substantial for stroke care.”
 

Nationwide data desirable

“Past publications from the U.S. have shown an increase in incidence of IVDU-related endocarditis, and the current publication emphasizes this worrying trend,” Manuel Bolognese, MD, head of the stroke center at the Lucerne (Switzerland) Cantonal Hospital, said in an interview. “The higher degree of hemorrhagic strokes and brain abscesses as further complications is alarming as well and shows that IVDU-related endocarditis is becoming a more and more relevant medical problem in the U.S., with high morbidity and mortality.”

The study period is long enough to show a clear trend of increasing incidence of IVDU-related endocarditis, Dr. Bolognese said. The study’s biggest weaknesses are its retrospective design and restriction to a single center.

“Without knowing the prevalence of drug abuse and the socioeconomical situation in Columbus, it is difficult to generalize these findings to other regions in the U.S.A. or even abroad,” he said.

Also, the abstract does not provide some essential information, said Dr. Bolognese. It would be important to know which valve was affected in each patient, which bacteria were identified, whether patients also used nonopioid drugs, and what each patient’s immune status was.

A lack of sterile material such as syringes could explain the apparent association between IVDU-associated endocarditis and low socioeconomic status, said Dr. Bolognese. Delayed presentation to medical institutions because of a lack of insurance could have led to a more complicated course.

“It would be interesting to see numbers from a broader spectrum in a nationwide registry,” said Dr. Bolognese. “It might be worth studying interventions to improve the hygienic aspects (like supply of sterile material, especially in the most vulnerable groups, like homeless people) or to provide easier access to emergency health care despite lack of insurance, which could decrease the incidence of IVDU.”

Dr. Nimjee and Dr. Bolognese disclosed no relevant financial relationships.

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

After a steep rise in the beginning of the COVID-19 pandemic and a slow decline that started in the summer, telehealth consults in dermatology remain far elevated over those provided prior to the COVID-19 pandemic. But it is not clear whether the current rate will fall further, be sustained, or even climb again, according to data presented and opinions expressed in a forum on this topic at the American Academy of Dermatology Virtual Meeting Experience.

There are many unknowns, not least of which is future reimbursement from the Centers for Medicare & Medicaid Services and other third-party payers, according to several participants in a scientific session devoted to this topic. The CARES Act, which was passed in the early stages of the pandemic, provided only a temporary increase in reimbursement for telehealth. Postpandemic payments for telehealth services are yet undetermined.

Many of the assembled experts are convinced that teledermatology will continue to be offered at far higher rates than prior to the pandemic, but many issues, including physician acceptance of this approach remain unresolved. This was reflected in an AAD survey of members conducted in June 2020.

“Seventy percent of dermatologists responded that teledermatology will continue, but only 58% reported that they intend to offer it,” after the pandemic, reported Jules Lipoff, MD, assistant professor of dermatology at the University of Pennsylvania, Philadelphia, who is one of the authors of the paper that reported the results.

The low relative proportion of dermatologists planning to participate in teledermatology might at least in part reflect uncertainty about reimbursement, according to Dr. Lipoff, who is the outgoing chair of the AAD teledermatology task force

Many dermatologists might find it difficult to opt out of telehealth. In some types of care, such as follow-up visits, a combination of patient demand and institutional policy, particularly if reimbursement is adequate, might compel or at least strongly incentivize teledermatology services.

“Now that telemedicine has gotten out there, we will never go back to what once was normal practice,” Dr. Lipoff predicted. According to Dr. Lipoff, there was a great deal of data even prior to the pandemic to conclude that mobile dermatology is “an acceptable equivalent” for delivering many types of dermatologic care.

The rapid evolution in telemedicine is remarkable. According to the results of the AAD survey, 14.1% of dermatologists had experience with teledermatology prior to the COVID-19 pandemic, which increased to 96.9% by June, 2020, when the survey was conducted. Nearly 600 dermatologists completed the survey, for a 13.6% response rate.

At the beginning of the pandemic, the CARES act, along with other pandemic legislation and policy changes, changed the landscape of telemedicine by providing reimbursement commensurate with in-office visits, modifying HIPAA regulations, and permitting reciprocal licensing to allow physicians to provide care to patients who had moved out of the state. While these were among the factors that facilitated the phenomenal growth in telemedicine, nearly all of these changes were temporary or are subject to revision.

“Reimbursement [for telehealth] was very low prior to the pandemic,” noted Elizabeth K. Jones, MD, assistant professor of dermatology, Thomas Jefferson University, Philadelphia. While many physicians and policy makers were convinced that reimbursement levels had to be increased temporarily to provide medical care when in-office visits were unsafe, Dr. Jones said it is unlikely that pandemic reimbursement rates will be preserved. But recent statements from the CMS foreshadow lower rates for most video and telephone consults, she added.

Reimbursement is not the only consideration. George Han, MD, PhD, chief of teledermatology at the Icahn School of Medicine at Mount Sinai, New York, spoke about the frustration of using imperfect tools. He, like many dermatologists, have become familiar with the difficulty of making a definitive diagnosis from transmitted images of skin lesions.

As long as patients communicate with personal computers and phones under variable lighting conditions, this problem might never go away, but suboptimal quality images do not necessarily preclude other types of consults, particularly follow-up visits, according to Dr. Han, who is also system medical director for dermatology at Mount Sinai Health System.

“Now that patients know about teledermatology, they are for it,” he said. He suggested that increased efficiency of follow-up using telemedicine for both patients and physicians might increase the frequency with which these types of visits are scheduled. Citing evidence that follow-up visits increase patient retention rates, Dr. Han sees these visits among the routine uses of telemedicine when the pandemic is over.

At the height of the pandemic, teledermatology was employed broadly, but after the pandemic, Dr. Han and others predict a narrower focus. Some consults, such as those for acne or other conditions reasonably treated on the basis of patient history, appear to lend themselves to telemedicine. Others, such as a skin check for malignancy, might not.

As the role of telemedicine is sorted out and finds its equilibrium in a postpandemic world, Dr. Lipoff pointed out the need to consider populations without good-quality internet access. Without specific strategies to ensure these patients are not forgotten, he warned of “wealthier patients consuming more than their fair share” of health care resources, further widening an existing disparity.

“Is telemedicine here to stay? It is clear that, yes, it is in some way,” said Dr. Lipoff, who sees no reason for dermatology to be an exception.
 

Dr. Lipoff reported a financial relationship with AcneAway. The other investigators reported no potential conflicts of interest related to telemedicine.

After a steep rise in the beginning of the COVID-19 pandemic and a slow decline that started in the summer, telehealth consults in dermatology remain far elevated over those provided prior to the COVID-19 pandemic. But it is not clear whether the current rate will fall further, be sustained, or even climb again, according to data presented and opinions expressed in a forum on this topic at the American Academy of Dermatology Virtual Meeting Experience.

There are many unknowns, not least of which is future reimbursement from the Centers for Medicare & Medicaid Services and other third-party payers, according to several participants in a scientific session devoted to this topic. The CARES Act, which was passed in the early stages of the pandemic, provided only a temporary increase in reimbursement for telehealth. Postpandemic payments for telehealth services are yet undetermined.

Many of the assembled experts are convinced that teledermatology will continue to be offered at far higher rates than prior to the pandemic, but many issues, including physician acceptance of this approach remain unresolved. This was reflected in an AAD survey of members conducted in June 2020.

“Seventy percent of dermatologists responded that teledermatology will continue, but only 58% reported that they intend to offer it,” after the pandemic, reported Jules Lipoff, MD, assistant professor of dermatology at the University of Pennsylvania, Philadelphia, who is one of the authors of the paper that reported the results.

The low relative proportion of dermatologists planning to participate in teledermatology might at least in part reflect uncertainty about reimbursement, according to Dr. Lipoff, who is the outgoing chair of the AAD teledermatology task force

Many dermatologists might find it difficult to opt out of telehealth. In some types of care, such as follow-up visits, a combination of patient demand and institutional policy, particularly if reimbursement is adequate, might compel or at least strongly incentivize teledermatology services.

“Now that telemedicine has gotten out there, we will never go back to what once was normal practice,” Dr. Lipoff predicted. According to Dr. Lipoff, there was a great deal of data even prior to the pandemic to conclude that mobile dermatology is “an acceptable equivalent” for delivering many types of dermatologic care.

The rapid evolution in telemedicine is remarkable. According to the results of the AAD survey, 14.1% of dermatologists had experience with teledermatology prior to the COVID-19 pandemic, which increased to 96.9% by June, 2020, when the survey was conducted. Nearly 600 dermatologists completed the survey, for a 13.6% response rate.

At the beginning of the pandemic, the CARES act, along with other pandemic legislation and policy changes, changed the landscape of telemedicine by providing reimbursement commensurate with in-office visits, modifying HIPAA regulations, and permitting reciprocal licensing to allow physicians to provide care to patients who had moved out of the state. While these were among the factors that facilitated the phenomenal growth in telemedicine, nearly all of these changes were temporary or are subject to revision.

“Reimbursement [for telehealth] was very low prior to the pandemic,” noted Elizabeth K. Jones, MD, assistant professor of dermatology, Thomas Jefferson University, Philadelphia. While many physicians and policy makers were convinced that reimbursement levels had to be increased temporarily to provide medical care when in-office visits were unsafe, Dr. Jones said it is unlikely that pandemic reimbursement rates will be preserved. But recent statements from the CMS foreshadow lower rates for most video and telephone consults, she added.

Reimbursement is not the only consideration. George Han, MD, PhD, chief of teledermatology at the Icahn School of Medicine at Mount Sinai, New York, spoke about the frustration of using imperfect tools. He, like many dermatologists, have become familiar with the difficulty of making a definitive diagnosis from transmitted images of skin lesions.

As long as patients communicate with personal computers and phones under variable lighting conditions, this problem might never go away, but suboptimal quality images do not necessarily preclude other types of consults, particularly follow-up visits, according to Dr. Han, who is also system medical director for dermatology at Mount Sinai Health System.

“Now that patients know about teledermatology, they are for it,” he said. He suggested that increased efficiency of follow-up using telemedicine for both patients and physicians might increase the frequency with which these types of visits are scheduled. Citing evidence that follow-up visits increase patient retention rates, Dr. Han sees these visits among the routine uses of telemedicine when the pandemic is over.

At the height of the pandemic, teledermatology was employed broadly, but after the pandemic, Dr. Han and others predict a narrower focus. Some consults, such as those for acne or other conditions reasonably treated on the basis of patient history, appear to lend themselves to telemedicine. Others, such as a skin check for malignancy, might not.

As the role of telemedicine is sorted out and finds its equilibrium in a postpandemic world, Dr. Lipoff pointed out the need to consider populations without good-quality internet access. Without specific strategies to ensure these patients are not forgotten, he warned of “wealthier patients consuming more than their fair share” of health care resources, further widening an existing disparity.

“Is telemedicine here to stay? It is clear that, yes, it is in some way,” said Dr. Lipoff, who sees no reason for dermatology to be an exception.
 

Dr. Lipoff reported a financial relationship with AcneAway. The other investigators reported no potential conflicts of interest related to telemedicine.

After a steep rise in the beginning of the COVID-19 pandemic and a slow decline that started in the summer, telehealth consults in dermatology remain far elevated over those provided prior to the COVID-19 pandemic. But it is not clear whether the current rate will fall further, be sustained, or even climb again, according to data presented and opinions expressed in a forum on this topic at the American Academy of Dermatology Virtual Meeting Experience.

There are many unknowns, not least of which is future reimbursement from the Centers for Medicare & Medicaid Services and other third-party payers, according to several participants in a scientific session devoted to this topic. The CARES Act, which was passed in the early stages of the pandemic, provided only a temporary increase in reimbursement for telehealth. Postpandemic payments for telehealth services are yet undetermined.

Many of the assembled experts are convinced that teledermatology will continue to be offered at far higher rates than prior to the pandemic, but many issues, including physician acceptance of this approach remain unresolved. This was reflected in an AAD survey of members conducted in June 2020.

“Seventy percent of dermatologists responded that teledermatology will continue, but only 58% reported that they intend to offer it,” after the pandemic, reported Jules Lipoff, MD, assistant professor of dermatology at the University of Pennsylvania, Philadelphia, who is one of the authors of the paper that reported the results.

The low relative proportion of dermatologists planning to participate in teledermatology might at least in part reflect uncertainty about reimbursement, according to Dr. Lipoff, who is the outgoing chair of the AAD teledermatology task force

Many dermatologists might find it difficult to opt out of telehealth. In some types of care, such as follow-up visits, a combination of patient demand and institutional policy, particularly if reimbursement is adequate, might compel or at least strongly incentivize teledermatology services.

“Now that telemedicine has gotten out there, we will never go back to what once was normal practice,” Dr. Lipoff predicted. According to Dr. Lipoff, there was a great deal of data even prior to the pandemic to conclude that mobile dermatology is “an acceptable equivalent” for delivering many types of dermatologic care.

The rapid evolution in telemedicine is remarkable. According to the results of the AAD survey, 14.1% of dermatologists had experience with teledermatology prior to the COVID-19 pandemic, which increased to 96.9% by June, 2020, when the survey was conducted. Nearly 600 dermatologists completed the survey, for a 13.6% response rate.

At the beginning of the pandemic, the CARES act, along with other pandemic legislation and policy changes, changed the landscape of telemedicine by providing reimbursement commensurate with in-office visits, modifying HIPAA regulations, and permitting reciprocal licensing to allow physicians to provide care to patients who had moved out of the state. While these were among the factors that facilitated the phenomenal growth in telemedicine, nearly all of these changes were temporary or are subject to revision.

“Reimbursement [for telehealth] was very low prior to the pandemic,” noted Elizabeth K. Jones, MD, assistant professor of dermatology, Thomas Jefferson University, Philadelphia. While many physicians and policy makers were convinced that reimbursement levels had to be increased temporarily to provide medical care when in-office visits were unsafe, Dr. Jones said it is unlikely that pandemic reimbursement rates will be preserved. But recent statements from the CMS foreshadow lower rates for most video and telephone consults, she added.

Reimbursement is not the only consideration. George Han, MD, PhD, chief of teledermatology at the Icahn School of Medicine at Mount Sinai, New York, spoke about the frustration of using imperfect tools. He, like many dermatologists, have become familiar with the difficulty of making a definitive diagnosis from transmitted images of skin lesions.

As long as patients communicate with personal computers and phones under variable lighting conditions, this problem might never go away, but suboptimal quality images do not necessarily preclude other types of consults, particularly follow-up visits, according to Dr. Han, who is also system medical director for dermatology at Mount Sinai Health System.

“Now that patients know about teledermatology, they are for it,” he said. He suggested that increased efficiency of follow-up using telemedicine for both patients and physicians might increase the frequency with which these types of visits are scheduled. Citing evidence that follow-up visits increase patient retention rates, Dr. Han sees these visits among the routine uses of telemedicine when the pandemic is over.

At the height of the pandemic, teledermatology was employed broadly, but after the pandemic, Dr. Han and others predict a narrower focus. Some consults, such as those for acne or other conditions reasonably treated on the basis of patient history, appear to lend themselves to telemedicine. Others, such as a skin check for malignancy, might not.

As the role of telemedicine is sorted out and finds its equilibrium in a postpandemic world, Dr. Lipoff pointed out the need to consider populations without good-quality internet access. Without specific strategies to ensure these patients are not forgotten, he warned of “wealthier patients consuming more than their fair share” of health care resources, further widening an existing disparity.

“Is telemedicine here to stay? It is clear that, yes, it is in some way,” said Dr. Lipoff, who sees no reason for dermatology to be an exception.
 

Dr. Lipoff reported a financial relationship with AcneAway. The other investigators reported no potential conflicts of interest related to telemedicine.