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ILD Subtypes in Rheumatoid Arthritis Carry Different Risk Factor Profiles
TOPLINE:
Older age, male sex, and seropositivity are linked to a higher risk for rheumatoid arthritis–interstitial lung disease (RA-ILD) with a usual interstitial pneumonia (UIP) pattern, while only seropositivity is associated with RA-ILD with a nonspecific interstitial pneumonia pattern (NSIP).
METHODOLOGY:
- Researchers conducted a case-control study using data from two cohorts in the Mass General Brigham Healthcare system to examine the risk factors associated with different subtypes of RA-ILD.
- They identified 208 patients with RA-ILD (mean age at RA diagnosis, 50.7 years; 67.3% women) and 547 control participants with RA but no ILD (mean age at RA diagnosis, 49.1 years; 78.1% women), who had high-resolution computed tomography (HRCT) imaging data available.
- RA-ILD subtypes such as RA-UIP, RA-NSIP, organizing pneumonia, and others were determined with HRCT scans.
- The associations between demographics, lifestyle, and serologic factors and RA-ILD subtypes were evaluated using multivariable logistic regression analysis.
TAKEAWAY:
- The RA-UIP subtype, the one with worst prognosis, was associated with older age during the time of RA diagnosis (odds ratio [OR], 1.03 per year; 95% CI, 1.01-1.05), male sex (OR, 2.15; 95% CI, 1.33-3.48), and seropositivity (OR, 2.08; 95% CI, 1.24-3.48).
- On the other hand, the RA-NSIP subtype was significantly associated only with seropositivity (OR, 3.21; 95% CI, 1.36-7.56).
- Nonfibrotic ILDs were significantly associated with positive smoking status (OR, 2.81; 95% CI, 1.52-5.21) and seropositivity (OR, 2.09; 95% CI, 1.19-3.67).
- The combination of male sex, seropositivity, and positive smoking status was associated with a nearly sevenfold increased risk for RA-UIP (OR, 6.89; 95% CI, 2.41-19.69), compared with having no RA-ILD risk factors.
IN PRACTICE:
“These findings suggest that RA-ILD subtypes may have distinct risk factor profiles and emphasize the importance of further efforts to understand RA-ILD disease heterogeneity to inform screening and prognostication strategies,” the authors wrote.
SOURCE:
The study was led by Gregory C. McDermott, MD, MPH, Brigham and Women’s Hospital, Boston, and was published online on September 11, 2024, in Arthritis Care & Research.
LIMITATIONS:
This study relied on HRCT imaging, which may have introduced selection bias within the control groups. RA disease activity measures were not available for the Mass General Brigham Biobank RA cohort, which limited the analysis of the influence of disease activity on the risk for RA-ILD. Both cohorts predominantly involved White patients, which may have limited the generalizability of the findings to more diverse populations.
DISCLOSURES:
Some authors were supported by the Rheumatology Research Foundation Scientist Development Award, a VERITY Pilot & Feasibility Research Award, the Société Française de Rhumatologie, the National Institute of Arthritis and Musculoskeletal and Skin Diseases, and other sources. The authors declared receiving grant support, consulting fees, and honoraria from various organizations and pharmaceutical companies.
This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication. A version of this article first appeared on Medscape.com.
TOPLINE:
Older age, male sex, and seropositivity are linked to a higher risk for rheumatoid arthritis–interstitial lung disease (RA-ILD) with a usual interstitial pneumonia (UIP) pattern, while only seropositivity is associated with RA-ILD with a nonspecific interstitial pneumonia pattern (NSIP).
METHODOLOGY:
- Researchers conducted a case-control study using data from two cohorts in the Mass General Brigham Healthcare system to examine the risk factors associated with different subtypes of RA-ILD.
- They identified 208 patients with RA-ILD (mean age at RA diagnosis, 50.7 years; 67.3% women) and 547 control participants with RA but no ILD (mean age at RA diagnosis, 49.1 years; 78.1% women), who had high-resolution computed tomography (HRCT) imaging data available.
- RA-ILD subtypes such as RA-UIP, RA-NSIP, organizing pneumonia, and others were determined with HRCT scans.
- The associations between demographics, lifestyle, and serologic factors and RA-ILD subtypes were evaluated using multivariable logistic regression analysis.
TAKEAWAY:
- The RA-UIP subtype, the one with worst prognosis, was associated with older age during the time of RA diagnosis (odds ratio [OR], 1.03 per year; 95% CI, 1.01-1.05), male sex (OR, 2.15; 95% CI, 1.33-3.48), and seropositivity (OR, 2.08; 95% CI, 1.24-3.48).
- On the other hand, the RA-NSIP subtype was significantly associated only with seropositivity (OR, 3.21; 95% CI, 1.36-7.56).
- Nonfibrotic ILDs were significantly associated with positive smoking status (OR, 2.81; 95% CI, 1.52-5.21) and seropositivity (OR, 2.09; 95% CI, 1.19-3.67).
- The combination of male sex, seropositivity, and positive smoking status was associated with a nearly sevenfold increased risk for RA-UIP (OR, 6.89; 95% CI, 2.41-19.69), compared with having no RA-ILD risk factors.
IN PRACTICE:
“These findings suggest that RA-ILD subtypes may have distinct risk factor profiles and emphasize the importance of further efforts to understand RA-ILD disease heterogeneity to inform screening and prognostication strategies,” the authors wrote.
SOURCE:
The study was led by Gregory C. McDermott, MD, MPH, Brigham and Women’s Hospital, Boston, and was published online on September 11, 2024, in Arthritis Care & Research.
LIMITATIONS:
This study relied on HRCT imaging, which may have introduced selection bias within the control groups. RA disease activity measures were not available for the Mass General Brigham Biobank RA cohort, which limited the analysis of the influence of disease activity on the risk for RA-ILD. Both cohorts predominantly involved White patients, which may have limited the generalizability of the findings to more diverse populations.
DISCLOSURES:
Some authors were supported by the Rheumatology Research Foundation Scientist Development Award, a VERITY Pilot & Feasibility Research Award, the Société Française de Rhumatologie, the National Institute of Arthritis and Musculoskeletal and Skin Diseases, and other sources. The authors declared receiving grant support, consulting fees, and honoraria from various organizations and pharmaceutical companies.
This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication. A version of this article first appeared on Medscape.com.
TOPLINE:
Older age, male sex, and seropositivity are linked to a higher risk for rheumatoid arthritis–interstitial lung disease (RA-ILD) with a usual interstitial pneumonia (UIP) pattern, while only seropositivity is associated with RA-ILD with a nonspecific interstitial pneumonia pattern (NSIP).
METHODOLOGY:
- Researchers conducted a case-control study using data from two cohorts in the Mass General Brigham Healthcare system to examine the risk factors associated with different subtypes of RA-ILD.
- They identified 208 patients with RA-ILD (mean age at RA diagnosis, 50.7 years; 67.3% women) and 547 control participants with RA but no ILD (mean age at RA diagnosis, 49.1 years; 78.1% women), who had high-resolution computed tomography (HRCT) imaging data available.
- RA-ILD subtypes such as RA-UIP, RA-NSIP, organizing pneumonia, and others were determined with HRCT scans.
- The associations between demographics, lifestyle, and serologic factors and RA-ILD subtypes were evaluated using multivariable logistic regression analysis.
TAKEAWAY:
- The RA-UIP subtype, the one with worst prognosis, was associated with older age during the time of RA diagnosis (odds ratio [OR], 1.03 per year; 95% CI, 1.01-1.05), male sex (OR, 2.15; 95% CI, 1.33-3.48), and seropositivity (OR, 2.08; 95% CI, 1.24-3.48).
- On the other hand, the RA-NSIP subtype was significantly associated only with seropositivity (OR, 3.21; 95% CI, 1.36-7.56).
- Nonfibrotic ILDs were significantly associated with positive smoking status (OR, 2.81; 95% CI, 1.52-5.21) and seropositivity (OR, 2.09; 95% CI, 1.19-3.67).
- The combination of male sex, seropositivity, and positive smoking status was associated with a nearly sevenfold increased risk for RA-UIP (OR, 6.89; 95% CI, 2.41-19.69), compared with having no RA-ILD risk factors.
IN PRACTICE:
“These findings suggest that RA-ILD subtypes may have distinct risk factor profiles and emphasize the importance of further efforts to understand RA-ILD disease heterogeneity to inform screening and prognostication strategies,” the authors wrote.
SOURCE:
The study was led by Gregory C. McDermott, MD, MPH, Brigham and Women’s Hospital, Boston, and was published online on September 11, 2024, in Arthritis Care & Research.
LIMITATIONS:
This study relied on HRCT imaging, which may have introduced selection bias within the control groups. RA disease activity measures were not available for the Mass General Brigham Biobank RA cohort, which limited the analysis of the influence of disease activity on the risk for RA-ILD. Both cohorts predominantly involved White patients, which may have limited the generalizability of the findings to more diverse populations.
DISCLOSURES:
Some authors were supported by the Rheumatology Research Foundation Scientist Development Award, a VERITY Pilot & Feasibility Research Award, the Société Française de Rhumatologie, the National Institute of Arthritis and Musculoskeletal and Skin Diseases, and other sources. The authors declared receiving grant support, consulting fees, and honoraria from various organizations and pharmaceutical companies.
This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication. A version of this article first appeared on Medscape.com.
Minimal Risks With SBRT in Stage I NSCLC
TOPLINE:
METHODOLOGY:
- SBRT is generally considered a safe treatment option in patients with stage I NSCLC who have medically inoperable tumors or who refuse surgery. Although rare, clinically relevant acute toxicities or early mortality can occur.
- In the current real-world analysis, researchers explored toxicity and 90-day mortality outcomes in patients who received SBRT to develop a better understanding of how often they happen and whether certain patients are at higher risk.
- Researchers analyzed data from the Dutch Lung Cancer Audit for Radiotherapy database, which included 7279 patients with stage I NSCLC who received SBRT between January 2017 and December 2021.
- Participants had a mean age of 72.5 years; 21.6% were older than 80 years. Over half were men (50.7%), most (73.3%) had WHO scores of 0-1, and about two thirds (64.6%) had cT1a-b tumors, mostly in the upper lobes (65.2%).
- Prediction models for acute toxicity and 90-day mortality were developed and internally validated using logistic regression analysis. Acute toxicity was defined as grade 2 or higher radiation pneumonitis or grade 3 or higher non-hematologic toxicity within 90 days after SBRT. The 90-day mortality was defined as mortality from any cause within 90 days after SBRT.
TAKEAWAY:
- Acute toxicity was observed in 3.8% patients, with more common types including dyspnea (1.8%), radiation pneumonitis (1.2%), fatigue (0.3%), and dysphagia (0.2%).
- Predictors for acute toxicity included WHO performance status of 2 or higher (adjusted odds ratio [aOR], 1.89; P = .003), middle or lower lobe tumor location (aOR, 1.38), cT1c-cT2a stage (aOR, 1.66), as well as lower forced expiratory volume in 1 second and higher mean lung dose.
- Overall, 90-day mortality was observed in 1.7% patients, with predictors including male sex, WHO performance status of 2 or higher (aOR, 6.11; P < .001), and acute toxicity (aOR, 8.89; P < .001).
- Advanced age was not associated with a higher risk for acute toxicity or 90-day mortality.
IN PRACTICE:
“This real-world study confirms that clinically relevant acute toxicity after lung SBRT for stage I NSCLC is rare,” and the 90-day mortality rate is low, the authors wrote. “Although these findings could inform clinical practice and enable individualized risk estimations, these parameters (and the others in the presented nomograms) should not serve as contraindication for SBRT as the benefits in terms of local control and survival outweigh the risks in most patients.”
SOURCE:
This study, led by Peter S.N. van Rossum, MD, PhD, Amsterdam UMC in Amsterdam, the Netherlands, was published online in Journal of Thoracic Oncology.
LIMITATIONS:
Patients with ultracentral tumor locations were excluded, which may have limited the generalizability of the findings. The Dutch Lung Cancer Audit for Radiotherapy database does not register whether a patient has interstitial lung disease or whether the treated tumor is at a central location, which carry increased risks for toxicity. The findings may not be applicable to patients receiving combined immunotherapy and SBRT, as this combination was not included in the current analysis. External validation of the prediction models is needed for application outside the Netherlands.
DISCLOSURES:
The authors declared no conflicts of interest.
This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication. A version of this article first appeared on Medscape.com.
TOPLINE:
METHODOLOGY:
- SBRT is generally considered a safe treatment option in patients with stage I NSCLC who have medically inoperable tumors or who refuse surgery. Although rare, clinically relevant acute toxicities or early mortality can occur.
- In the current real-world analysis, researchers explored toxicity and 90-day mortality outcomes in patients who received SBRT to develop a better understanding of how often they happen and whether certain patients are at higher risk.
- Researchers analyzed data from the Dutch Lung Cancer Audit for Radiotherapy database, which included 7279 patients with stage I NSCLC who received SBRT between January 2017 and December 2021.
- Participants had a mean age of 72.5 years; 21.6% were older than 80 years. Over half were men (50.7%), most (73.3%) had WHO scores of 0-1, and about two thirds (64.6%) had cT1a-b tumors, mostly in the upper lobes (65.2%).
- Prediction models for acute toxicity and 90-day mortality were developed and internally validated using logistic regression analysis. Acute toxicity was defined as grade 2 or higher radiation pneumonitis or grade 3 or higher non-hematologic toxicity within 90 days after SBRT. The 90-day mortality was defined as mortality from any cause within 90 days after SBRT.
TAKEAWAY:
- Acute toxicity was observed in 3.8% patients, with more common types including dyspnea (1.8%), radiation pneumonitis (1.2%), fatigue (0.3%), and dysphagia (0.2%).
- Predictors for acute toxicity included WHO performance status of 2 or higher (adjusted odds ratio [aOR], 1.89; P = .003), middle or lower lobe tumor location (aOR, 1.38), cT1c-cT2a stage (aOR, 1.66), as well as lower forced expiratory volume in 1 second and higher mean lung dose.
- Overall, 90-day mortality was observed in 1.7% patients, with predictors including male sex, WHO performance status of 2 or higher (aOR, 6.11; P < .001), and acute toxicity (aOR, 8.89; P < .001).
- Advanced age was not associated with a higher risk for acute toxicity or 90-day mortality.
IN PRACTICE:
“This real-world study confirms that clinically relevant acute toxicity after lung SBRT for stage I NSCLC is rare,” and the 90-day mortality rate is low, the authors wrote. “Although these findings could inform clinical practice and enable individualized risk estimations, these parameters (and the others in the presented nomograms) should not serve as contraindication for SBRT as the benefits in terms of local control and survival outweigh the risks in most patients.”
SOURCE:
This study, led by Peter S.N. van Rossum, MD, PhD, Amsterdam UMC in Amsterdam, the Netherlands, was published online in Journal of Thoracic Oncology.
LIMITATIONS:
Patients with ultracentral tumor locations were excluded, which may have limited the generalizability of the findings. The Dutch Lung Cancer Audit for Radiotherapy database does not register whether a patient has interstitial lung disease or whether the treated tumor is at a central location, which carry increased risks for toxicity. The findings may not be applicable to patients receiving combined immunotherapy and SBRT, as this combination was not included in the current analysis. External validation of the prediction models is needed for application outside the Netherlands.
DISCLOSURES:
The authors declared no conflicts of interest.
This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication. A version of this article first appeared on Medscape.com.
TOPLINE:
METHODOLOGY:
- SBRT is generally considered a safe treatment option in patients with stage I NSCLC who have medically inoperable tumors or who refuse surgery. Although rare, clinically relevant acute toxicities or early mortality can occur.
- In the current real-world analysis, researchers explored toxicity and 90-day mortality outcomes in patients who received SBRT to develop a better understanding of how often they happen and whether certain patients are at higher risk.
- Researchers analyzed data from the Dutch Lung Cancer Audit for Radiotherapy database, which included 7279 patients with stage I NSCLC who received SBRT between January 2017 and December 2021.
- Participants had a mean age of 72.5 years; 21.6% were older than 80 years. Over half were men (50.7%), most (73.3%) had WHO scores of 0-1, and about two thirds (64.6%) had cT1a-b tumors, mostly in the upper lobes (65.2%).
- Prediction models for acute toxicity and 90-day mortality were developed and internally validated using logistic regression analysis. Acute toxicity was defined as grade 2 or higher radiation pneumonitis or grade 3 or higher non-hematologic toxicity within 90 days after SBRT. The 90-day mortality was defined as mortality from any cause within 90 days after SBRT.
TAKEAWAY:
- Acute toxicity was observed in 3.8% patients, with more common types including dyspnea (1.8%), radiation pneumonitis (1.2%), fatigue (0.3%), and dysphagia (0.2%).
- Predictors for acute toxicity included WHO performance status of 2 or higher (adjusted odds ratio [aOR], 1.89; P = .003), middle or lower lobe tumor location (aOR, 1.38), cT1c-cT2a stage (aOR, 1.66), as well as lower forced expiratory volume in 1 second and higher mean lung dose.
- Overall, 90-day mortality was observed in 1.7% patients, with predictors including male sex, WHO performance status of 2 or higher (aOR, 6.11; P < .001), and acute toxicity (aOR, 8.89; P < .001).
- Advanced age was not associated with a higher risk for acute toxicity or 90-day mortality.
IN PRACTICE:
“This real-world study confirms that clinically relevant acute toxicity after lung SBRT for stage I NSCLC is rare,” and the 90-day mortality rate is low, the authors wrote. “Although these findings could inform clinical practice and enable individualized risk estimations, these parameters (and the others in the presented nomograms) should not serve as contraindication for SBRT as the benefits in terms of local control and survival outweigh the risks in most patients.”
SOURCE:
This study, led by Peter S.N. van Rossum, MD, PhD, Amsterdam UMC in Amsterdam, the Netherlands, was published online in Journal of Thoracic Oncology.
LIMITATIONS:
Patients with ultracentral tumor locations were excluded, which may have limited the generalizability of the findings. The Dutch Lung Cancer Audit for Radiotherapy database does not register whether a patient has interstitial lung disease or whether the treated tumor is at a central location, which carry increased risks for toxicity. The findings may not be applicable to patients receiving combined immunotherapy and SBRT, as this combination was not included in the current analysis. External validation of the prediction models is needed for application outside the Netherlands.
DISCLOSURES:
The authors declared no conflicts of interest.
This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication. A version of this article first appeared on Medscape.com.
FDA Okays Osimertinib After CRT in Locally Advanced, Unresectable NSCLC
Specifically, the third-generation epidermal growth factor receptor (EGFR) tyrosine kinase inhibitor (TKI) was approved for patients whose disease has not progressed during or after concurrent or sequential platinum-based chemoradiation therapy and whose tumors have EGFR exon 19 deletions or exon 21 L858R mutations. Such EGFR mutations can be detected by an FDA-approved test.
The FDA approved osimertinib in combination with platinum-based chemotherapy as first-line treatment for patients with locally advanced or metastatic NSCLC with the same mutations in February. The EGFR-TKI also carries other indications, including as first-line monotherapy for locally advanced or metastatic EGFR-mutated NSCLC.
Trial Findings Supporting Latest Approval
AstraZeneca announced in June that osimertinib had been granted Priority Review and Breakthrough Therapy Designation for its newest indication.
The September 25 approval was based on findings from the randomized, placebo-controlled LAURA trial of 216 patients, which demonstrated improved median progression-free survival with osimertinib vs placebo (39.1 vs 5.6 months; hazard ratio, 0.16). Overall survival results were immature at the most recent analysis, but “no trend towards a detriment was observed,” with 36% of prespecified deaths for the final analysis reported, according to an FDA press release.
Adverse Events
Study participants were randomized 2:1 to receive the osimertinib recommended dose of 80 mg given orally once daily or placebo until disease progression or unacceptable toxicity. The most common adverse reactions, occurring in at least 20% of patients, were lymphopenia, leukopenia, interstitial lung disease/pneumonitis, thrombocytopenia, neutropenia, rash, diarrhea, nail toxicity, musculoskeletal pain, cough, and COVID-19 infection.
A version of this article first appeared on Medscape.com.
Specifically, the third-generation epidermal growth factor receptor (EGFR) tyrosine kinase inhibitor (TKI) was approved for patients whose disease has not progressed during or after concurrent or sequential platinum-based chemoradiation therapy and whose tumors have EGFR exon 19 deletions or exon 21 L858R mutations. Such EGFR mutations can be detected by an FDA-approved test.
The FDA approved osimertinib in combination with platinum-based chemotherapy as first-line treatment for patients with locally advanced or metastatic NSCLC with the same mutations in February. The EGFR-TKI also carries other indications, including as first-line monotherapy for locally advanced or metastatic EGFR-mutated NSCLC.
Trial Findings Supporting Latest Approval
AstraZeneca announced in June that osimertinib had been granted Priority Review and Breakthrough Therapy Designation for its newest indication.
The September 25 approval was based on findings from the randomized, placebo-controlled LAURA trial of 216 patients, which demonstrated improved median progression-free survival with osimertinib vs placebo (39.1 vs 5.6 months; hazard ratio, 0.16). Overall survival results were immature at the most recent analysis, but “no trend towards a detriment was observed,” with 36% of prespecified deaths for the final analysis reported, according to an FDA press release.
Adverse Events
Study participants were randomized 2:1 to receive the osimertinib recommended dose of 80 mg given orally once daily or placebo until disease progression or unacceptable toxicity. The most common adverse reactions, occurring in at least 20% of patients, were lymphopenia, leukopenia, interstitial lung disease/pneumonitis, thrombocytopenia, neutropenia, rash, diarrhea, nail toxicity, musculoskeletal pain, cough, and COVID-19 infection.
A version of this article first appeared on Medscape.com.
Specifically, the third-generation epidermal growth factor receptor (EGFR) tyrosine kinase inhibitor (TKI) was approved for patients whose disease has not progressed during or after concurrent or sequential platinum-based chemoradiation therapy and whose tumors have EGFR exon 19 deletions or exon 21 L858R mutations. Such EGFR mutations can be detected by an FDA-approved test.
The FDA approved osimertinib in combination with platinum-based chemotherapy as first-line treatment for patients with locally advanced or metastatic NSCLC with the same mutations in February. The EGFR-TKI also carries other indications, including as first-line monotherapy for locally advanced or metastatic EGFR-mutated NSCLC.
Trial Findings Supporting Latest Approval
AstraZeneca announced in June that osimertinib had been granted Priority Review and Breakthrough Therapy Designation for its newest indication.
The September 25 approval was based on findings from the randomized, placebo-controlled LAURA trial of 216 patients, which demonstrated improved median progression-free survival with osimertinib vs placebo (39.1 vs 5.6 months; hazard ratio, 0.16). Overall survival results were immature at the most recent analysis, but “no trend towards a detriment was observed,” with 36% of prespecified deaths for the final analysis reported, according to an FDA press release.
Adverse Events
Study participants were randomized 2:1 to receive the osimertinib recommended dose of 80 mg given orally once daily or placebo until disease progression or unacceptable toxicity. The most common adverse reactions, occurring in at least 20% of patients, were lymphopenia, leukopenia, interstitial lung disease/pneumonitis, thrombocytopenia, neutropenia, rash, diarrhea, nail toxicity, musculoskeletal pain, cough, and COVID-19 infection.
A version of this article first appeared on Medscape.com.
Pertussis Rates Up Compared With Recent Years
, according to data from the Centers for Disease Control and Prevention (CDC). Reports from several states illustrate this trend, thought to be due to reduced immunity across the country.
The Alaska Department of Health issued a statement on its website about the significant increase in pertussis cases in the state during the summer, with 90 cases in July and 61 in August, compared with 24 in June and a total of 26 cases in 2023.
Similarly, the Florida Department of Health reported a pertussis increase in July 2024 that was higher than the June 2024 case count and also above the previous 5-year average.
Experts in these and other states suggest that several factors are driving the nationwide increase, including the fact that fewer people are consistently wearing masks. The mass masking during the COVID-19 pandemic caused a significant drop in pertussis, but the latest data suggest a return to prepandemic levels, and waning immunity likely plays a role as well.
Pertussis, also known as whooping cough, typically begins with symptoms similar to those of the common cold, including runny nose, sneezing, mild fever, and cough, according to the CDC. However, babies with whooping cough may experience trouble breathing rather than a cough. The coughing fits often associated with pertussis may not start until 2 weeks after the onset of other symptoms, according to the CDC.
Those who have been vaccinated against pertussis can still become infected, but the risk is lower, and the illness, if it occurs, is likely to be milder. Complications such as apnea, pneumonia, and convulsions can occur in babies younger than 1 year, especially if they have not been vaccinated, according to the CDC.
Beyond Easing Pandemic Precautions
Many respiratory-based infections dipped during the COVID-19 pandemic, almost certainly from the multifactorial interventions of masking, distancing, and the general lack of comingling, said David J. Cennimo, MD, associate professor of medicine & pediatrics in the Division of Infectious Diseases at Rutgers New Jersey Medical School, Newark, New Jersey, in an interview.
The number of cases of many of these diseases returned to previous levels after COVID-19 restrictions were lifted, he said.
“However, we know pertussis immunity wanes over time. Children get DTaP at 2, 4, 6, and 15 months, and a Tdap booster at 11-12 years old gets them to adulthood,” Dr. Cennimo said. Adults should be getting a Tdap every 10 years, he added.
The latest available CDC data indicate that Tdap vaccine coverage in adults is approximately 40%, which means that there may be a large number of susceptible people who can become infected and propagate to others, said Dr. Cennimo.
Not Just the Young Ones
A recent pertussis outbreak among college students in Virginia highlighted the fact that the infection can affect all ages, and that the effectiveness of childhood vaccines may decrease over time. The majority of the recently diagnosed cases occurred in individuals who had been previously vaccinated, according to a press release from the Virginia Department of Health.
Clinical Clues
The initial stage of pertussis infection looks like a common cold with symptoms of upper respiratory infection, Dr. Cennimo told this news organization. “Unless there is reason to suspect pertussis exposure, it would almost certainly be missed,” he noted.
The characteristic barking/seal-like cough is mostly seen in children, said Dr. Cennimo. Adults and children can experience coughing fits that can lead to shortness of breath and/or vomiting, which would raise suspicion for pertussis, but is not universally present, he said. The convalescent stage of pertussis can be prolonged and is characterized by chronic coughing. “In the past, pertussis had been called the 100-day cough,” and at that point, treatment is ineffective, Dr. Cennimo said.
In clinical practice, “I advise everyone to get the Tdap vaccine every 10 years,” and remember that the “Td” is the every 10-year tetanus shot as well, Dr. Cennimo told this news organization. Reassure patients that the Tdap can be given with other vaccines, he said, and remind patients that, as with any of the respiratory illnesses, they should stay home if sick, cover a cough, consider wearing a mask in public, and wash hands frequently, he said.
Dr. Cennimo had no financial conflicts to disclose.
A version of this article first appeared on Medscape.com.
, according to data from the Centers for Disease Control and Prevention (CDC). Reports from several states illustrate this trend, thought to be due to reduced immunity across the country.
The Alaska Department of Health issued a statement on its website about the significant increase in pertussis cases in the state during the summer, with 90 cases in July and 61 in August, compared with 24 in June and a total of 26 cases in 2023.
Similarly, the Florida Department of Health reported a pertussis increase in July 2024 that was higher than the June 2024 case count and also above the previous 5-year average.
Experts in these and other states suggest that several factors are driving the nationwide increase, including the fact that fewer people are consistently wearing masks. The mass masking during the COVID-19 pandemic caused a significant drop in pertussis, but the latest data suggest a return to prepandemic levels, and waning immunity likely plays a role as well.
Pertussis, also known as whooping cough, typically begins with symptoms similar to those of the common cold, including runny nose, sneezing, mild fever, and cough, according to the CDC. However, babies with whooping cough may experience trouble breathing rather than a cough. The coughing fits often associated with pertussis may not start until 2 weeks after the onset of other symptoms, according to the CDC.
Those who have been vaccinated against pertussis can still become infected, but the risk is lower, and the illness, if it occurs, is likely to be milder. Complications such as apnea, pneumonia, and convulsions can occur in babies younger than 1 year, especially if they have not been vaccinated, according to the CDC.
Beyond Easing Pandemic Precautions
Many respiratory-based infections dipped during the COVID-19 pandemic, almost certainly from the multifactorial interventions of masking, distancing, and the general lack of comingling, said David J. Cennimo, MD, associate professor of medicine & pediatrics in the Division of Infectious Diseases at Rutgers New Jersey Medical School, Newark, New Jersey, in an interview.
The number of cases of many of these diseases returned to previous levels after COVID-19 restrictions were lifted, he said.
“However, we know pertussis immunity wanes over time. Children get DTaP at 2, 4, 6, and 15 months, and a Tdap booster at 11-12 years old gets them to adulthood,” Dr. Cennimo said. Adults should be getting a Tdap every 10 years, he added.
The latest available CDC data indicate that Tdap vaccine coverage in adults is approximately 40%, which means that there may be a large number of susceptible people who can become infected and propagate to others, said Dr. Cennimo.
Not Just the Young Ones
A recent pertussis outbreak among college students in Virginia highlighted the fact that the infection can affect all ages, and that the effectiveness of childhood vaccines may decrease over time. The majority of the recently diagnosed cases occurred in individuals who had been previously vaccinated, according to a press release from the Virginia Department of Health.
Clinical Clues
The initial stage of pertussis infection looks like a common cold with symptoms of upper respiratory infection, Dr. Cennimo told this news organization. “Unless there is reason to suspect pertussis exposure, it would almost certainly be missed,” he noted.
The characteristic barking/seal-like cough is mostly seen in children, said Dr. Cennimo. Adults and children can experience coughing fits that can lead to shortness of breath and/or vomiting, which would raise suspicion for pertussis, but is not universally present, he said. The convalescent stage of pertussis can be prolonged and is characterized by chronic coughing. “In the past, pertussis had been called the 100-day cough,” and at that point, treatment is ineffective, Dr. Cennimo said.
In clinical practice, “I advise everyone to get the Tdap vaccine every 10 years,” and remember that the “Td” is the every 10-year tetanus shot as well, Dr. Cennimo told this news organization. Reassure patients that the Tdap can be given with other vaccines, he said, and remind patients that, as with any of the respiratory illnesses, they should stay home if sick, cover a cough, consider wearing a mask in public, and wash hands frequently, he said.
Dr. Cennimo had no financial conflicts to disclose.
A version of this article first appeared on Medscape.com.
, according to data from the Centers for Disease Control and Prevention (CDC). Reports from several states illustrate this trend, thought to be due to reduced immunity across the country.
The Alaska Department of Health issued a statement on its website about the significant increase in pertussis cases in the state during the summer, with 90 cases in July and 61 in August, compared with 24 in June and a total of 26 cases in 2023.
Similarly, the Florida Department of Health reported a pertussis increase in July 2024 that was higher than the June 2024 case count and also above the previous 5-year average.
Experts in these and other states suggest that several factors are driving the nationwide increase, including the fact that fewer people are consistently wearing masks. The mass masking during the COVID-19 pandemic caused a significant drop in pertussis, but the latest data suggest a return to prepandemic levels, and waning immunity likely plays a role as well.
Pertussis, also known as whooping cough, typically begins with symptoms similar to those of the common cold, including runny nose, sneezing, mild fever, and cough, according to the CDC. However, babies with whooping cough may experience trouble breathing rather than a cough. The coughing fits often associated with pertussis may not start until 2 weeks after the onset of other symptoms, according to the CDC.
Those who have been vaccinated against pertussis can still become infected, but the risk is lower, and the illness, if it occurs, is likely to be milder. Complications such as apnea, pneumonia, and convulsions can occur in babies younger than 1 year, especially if they have not been vaccinated, according to the CDC.
Beyond Easing Pandemic Precautions
Many respiratory-based infections dipped during the COVID-19 pandemic, almost certainly from the multifactorial interventions of masking, distancing, and the general lack of comingling, said David J. Cennimo, MD, associate professor of medicine & pediatrics in the Division of Infectious Diseases at Rutgers New Jersey Medical School, Newark, New Jersey, in an interview.
The number of cases of many of these diseases returned to previous levels after COVID-19 restrictions were lifted, he said.
“However, we know pertussis immunity wanes over time. Children get DTaP at 2, 4, 6, and 15 months, and a Tdap booster at 11-12 years old gets them to adulthood,” Dr. Cennimo said. Adults should be getting a Tdap every 10 years, he added.
The latest available CDC data indicate that Tdap vaccine coverage in adults is approximately 40%, which means that there may be a large number of susceptible people who can become infected and propagate to others, said Dr. Cennimo.
Not Just the Young Ones
A recent pertussis outbreak among college students in Virginia highlighted the fact that the infection can affect all ages, and that the effectiveness of childhood vaccines may decrease over time. The majority of the recently diagnosed cases occurred in individuals who had been previously vaccinated, according to a press release from the Virginia Department of Health.
Clinical Clues
The initial stage of pertussis infection looks like a common cold with symptoms of upper respiratory infection, Dr. Cennimo told this news organization. “Unless there is reason to suspect pertussis exposure, it would almost certainly be missed,” he noted.
The characteristic barking/seal-like cough is mostly seen in children, said Dr. Cennimo. Adults and children can experience coughing fits that can lead to shortness of breath and/or vomiting, which would raise suspicion for pertussis, but is not universally present, he said. The convalescent stage of pertussis can be prolonged and is characterized by chronic coughing. “In the past, pertussis had been called the 100-day cough,” and at that point, treatment is ineffective, Dr. Cennimo said.
In clinical practice, “I advise everyone to get the Tdap vaccine every 10 years,” and remember that the “Td” is the every 10-year tetanus shot as well, Dr. Cennimo told this news organization. Reassure patients that the Tdap can be given with other vaccines, he said, and remind patients that, as with any of the respiratory illnesses, they should stay home if sick, cover a cough, consider wearing a mask in public, and wash hands frequently, he said.
Dr. Cennimo had no financial conflicts to disclose.
A version of this article first appeared on Medscape.com.
A Rare Case of a Splenic Abscess as the Origin of Illness in Exudative Pleural Effusion
Splenic abscesses are a rare occurrence that represent a marginal proportion of intra-abdominal infections. One study found splenic abscesses in only 0.14% to 0.70% of autopsies and none of the 540 abdominal abscesses they examined originated in the spleen.1 Patients with splenic abscesses tend to present with nonspecific symptoms such as fevers, chills, and abdominal pain.2 Imaging modalities such as abdominal ultrasound and computed tomography (CT) are vital to the workup and diagnosis identification.2 Splenic abscesses are generally associated with another underlying process, as seen in patients who are affected by endocarditis, trauma, metastatic infection, splenic infarction, or neoplasia.2
Pleural effusions, or the buildup of fluid within the pleural space, is a common condition typically secondary to another disease.3 Clinical identification of the primary condition may be challenging.3 In the absence of a clear etiology, such as obvious signs of congestive heart failure, further differentiation relies upon pleural fluid analysis, beginning with the distinction between exudate (inflammatory) and transudate (noninflammatory). 3,4 This distinction can be made using Light’s criteria, which relies on protein and lactate dehydrogenase (LDH) ratios between the pleural fluid and serum (Table 1).5 Though rare, half of splenic abscesses are associated with pleural effusion.6 As an inflammatory condition, splenic abscesses have been classically described as a cause of exudative pleural effusions.5,6
A myelodysplastic syndrome is a group of diseases that arise from malignant hematopoietic stem cells, leading to the proliferation of the malignant cells and faulty production of other bone marrow products.7 These disorders can range from single to multilineage dysplasia. Cells are often left in an immature blast form, unable to function appropriately, and vulnerable to destruction. Patients with myeloproliferative disorders frequently suffer from leukopenia and infections attributable to known quantitative and qualitative defects of neutrophils.8
CASE PRESENTATION
A male aged 80 years presented to the Central Texas Veterans Affairs Hospital (CTVAH) with shortness of breath, weight loss, and fever. On admission, his medical history was notable for atrial fibrillation, myelodysplastic syndrome, hypertension, hyperlipidemia, stable ascending aortic aneurysm, and Vitamin B12 deficiency. A chest CT showed a large left pleural effusion (Figure 1). Additionally, the radiology report noted a nonspecific 4- to 5-cm lobulated subdiaphragmatic mass within the anterior dome of the spleen with surrounding soft tissue swelling and splenomegaly (Figure 2).
Initial thoracentesis was performed with 1500 mL of straw-colored fluid negative for bacteria, fungi, malignancy, and acid-fast organisms (Tables 2 and 3). The pleural effusion persisted, requiring a second thoracentesis 2 days later that was positive for Escherichia coli (E coli). Given the exudative nature and positive culture, a chest tube was placed, and the pleural effusion was therefore felt to be an empyema, arousing suspicion that the splenic mass seen on CT was an abscess. The site was accessed by interventional radiology, purulent fluid aspirated, and a drain was placed. Cultures grew E coli sensitive to ceftriaxone. Despite receiving intravenous ceftriaxone 2 g daily, the pleural effusion became further complicated due to chest tube obstruction and persistent drainage.
The patient was discharged to Baylor Scott & White Medical Center in Temple, Texas where he underwent decortication with cardiothoracic surgery with several pleural adhesions noted. Following surgery the patient was readmitted to CTVAH and continued ceftriaxone therapy following the infectious disease specialist's recommendation. He was discharged with plans to return to CTVAH for continued care. The patient was readmitted and transitioned to oral levofloxacin 500 mg daily and received physical and occupational therapy. He showed dramatic improvement on this regimen, with a 3-week follow-up CT that indicated only a small left pleural effusion and a 28 mm × 11 mm × 10 mm lesion in the anterior superior spleen. The patient had not returned for further evaluation by thoracic surgery; however, he has continued to see CTVAH primary care without reported recurrence of symptoms.
DISCUSSION
Splenic abscesses are a rare condition typically characterized by hematogenous spread of bacteria from another source, most commonly the endocardium.2 Other differential diagnoses include bacteremia or spread from an intra-abdominal site.2 Staphylococcus aureus and E coli are the most common bacteria seen in splenic abscesses. 2 Treatment includes antibiotics, percutaneous drainage, and, as a last resort, splenectomy.2
Our patient was found to have grown E coli, but no source indicative of spread was identified. He had negative blood cultures, negative findings for intra-abdominal pathologies on CT scans, and a negative echocardiogram for endocarditis. A bronchoscopy showed no evidence of a source from the lungs, and specimens taken from the pleural adhesions were negative for malignancy and bacteria.
This patient had risk factors for the illness, namely his history of being immunocompromised secondary to myelodysplastic syndrome.7 Accordingly, the patient showed persistent leukopenia with neutropenia and lymphocytopenia, which would not be expected for most patients with such an extensive infection. 8 While being immunocompromised undoubtedly contributed to the severity of the patient’s presentation and slow recovery, it does not explain the etiology or origin of his infection. This patient differs from current literature in that his splenic abscess was truly idiopathic rather than resulting from an alternative source.
Complications of splenic abscesses include pleural effusions, as seen with this patient, as well as pneumonia, pneumothorax, hemorrhage, subphrenic abscess, and intraabdominal perforation, among others.2 We determined conclusively that the patient’s pleural effusion was secondary to the splenic abscess, and excluded other bacterial foci strongly suggests that the spleen was the origin of the illness.
CONCLUSIONS
This case suggests splenic abscesses should be considered when evaluating pleural effusion. It further demonstrates that the spleen may be the central source of infection in the absence of iatrogenic inoculation or bacteremia. We hope our findings may lead to earlier identification in similar scenarios and improved patient outcomes in a multidisciplinary approach.
- Lee WS, Choi ST, Kim KK. Splenic abscess: a single institution study and review of the literature. Yonsei Med J. 2011;52(2):288-292. doi:10.3349/ymj.2011.52.2.288
- Lotfollahzadeh S, Mathew G, Zemaitis MR. Splenic Abscess. In: StatPearls. StatPearls Publishing; June 3, 2023.
- Jany B, Welte T. Pleural effusion in adults-etiology, diagnosis, and treatment. Dtsch Arztebl Int. 2019;116(21):377- 386. doi:10.3238/arztebl.2019.0377
- Light RW. Pleural effusions. Med Clin North Am. 2011;95(6):1055-1070. doi:10.1016/j.mcna.2011.08.005
- Feller-Kopman D, Light R. Pleural Disease. N Engl J Med. 2018;378(18):1754. doi:10.1056/NEJMc1803858
- Ferreiro L, Casal A, Toubes ME, et al. Pleural effusion due to nonmalignant gastrointestinal disease. ERJ Open Res. 2023;9(3):00290-2022. doi:10.1183/23120541.00290-2022
- Hasserjian RP. Myelodysplastic syndrome updated. Pathobiology. 2019;86(1):7-13. doi:10.1159/000489702
- Toma A, Fenaux P, Dreyfus F, Cordonnier C. Infections in myelodysplastic syndromes. Haematologica. 2012;97(10):1459- 1470. doi:10.3324/haematol2012.063420
Splenic abscesses are a rare occurrence that represent a marginal proportion of intra-abdominal infections. One study found splenic abscesses in only 0.14% to 0.70% of autopsies and none of the 540 abdominal abscesses they examined originated in the spleen.1 Patients with splenic abscesses tend to present with nonspecific symptoms such as fevers, chills, and abdominal pain.2 Imaging modalities such as abdominal ultrasound and computed tomography (CT) are vital to the workup and diagnosis identification.2 Splenic abscesses are generally associated with another underlying process, as seen in patients who are affected by endocarditis, trauma, metastatic infection, splenic infarction, or neoplasia.2
Pleural effusions, or the buildup of fluid within the pleural space, is a common condition typically secondary to another disease.3 Clinical identification of the primary condition may be challenging.3 In the absence of a clear etiology, such as obvious signs of congestive heart failure, further differentiation relies upon pleural fluid analysis, beginning with the distinction between exudate (inflammatory) and transudate (noninflammatory). 3,4 This distinction can be made using Light’s criteria, which relies on protein and lactate dehydrogenase (LDH) ratios between the pleural fluid and serum (Table 1).5 Though rare, half of splenic abscesses are associated with pleural effusion.6 As an inflammatory condition, splenic abscesses have been classically described as a cause of exudative pleural effusions.5,6
A myelodysplastic syndrome is a group of diseases that arise from malignant hematopoietic stem cells, leading to the proliferation of the malignant cells and faulty production of other bone marrow products.7 These disorders can range from single to multilineage dysplasia. Cells are often left in an immature blast form, unable to function appropriately, and vulnerable to destruction. Patients with myeloproliferative disorders frequently suffer from leukopenia and infections attributable to known quantitative and qualitative defects of neutrophils.8
CASE PRESENTATION
A male aged 80 years presented to the Central Texas Veterans Affairs Hospital (CTVAH) with shortness of breath, weight loss, and fever. On admission, his medical history was notable for atrial fibrillation, myelodysplastic syndrome, hypertension, hyperlipidemia, stable ascending aortic aneurysm, and Vitamin B12 deficiency. A chest CT showed a large left pleural effusion (Figure 1). Additionally, the radiology report noted a nonspecific 4- to 5-cm lobulated subdiaphragmatic mass within the anterior dome of the spleen with surrounding soft tissue swelling and splenomegaly (Figure 2).
Initial thoracentesis was performed with 1500 mL of straw-colored fluid negative for bacteria, fungi, malignancy, and acid-fast organisms (Tables 2 and 3). The pleural effusion persisted, requiring a second thoracentesis 2 days later that was positive for Escherichia coli (E coli). Given the exudative nature and positive culture, a chest tube was placed, and the pleural effusion was therefore felt to be an empyema, arousing suspicion that the splenic mass seen on CT was an abscess. The site was accessed by interventional radiology, purulent fluid aspirated, and a drain was placed. Cultures grew E coli sensitive to ceftriaxone. Despite receiving intravenous ceftriaxone 2 g daily, the pleural effusion became further complicated due to chest tube obstruction and persistent drainage.
The patient was discharged to Baylor Scott & White Medical Center in Temple, Texas where he underwent decortication with cardiothoracic surgery with several pleural adhesions noted. Following surgery the patient was readmitted to CTVAH and continued ceftriaxone therapy following the infectious disease specialist's recommendation. He was discharged with plans to return to CTVAH for continued care. The patient was readmitted and transitioned to oral levofloxacin 500 mg daily and received physical and occupational therapy. He showed dramatic improvement on this regimen, with a 3-week follow-up CT that indicated only a small left pleural effusion and a 28 mm × 11 mm × 10 mm lesion in the anterior superior spleen. The patient had not returned for further evaluation by thoracic surgery; however, he has continued to see CTVAH primary care without reported recurrence of symptoms.
DISCUSSION
Splenic abscesses are a rare condition typically characterized by hematogenous spread of bacteria from another source, most commonly the endocardium.2 Other differential diagnoses include bacteremia or spread from an intra-abdominal site.2 Staphylococcus aureus and E coli are the most common bacteria seen in splenic abscesses. 2 Treatment includes antibiotics, percutaneous drainage, and, as a last resort, splenectomy.2
Our patient was found to have grown E coli, but no source indicative of spread was identified. He had negative blood cultures, negative findings for intra-abdominal pathologies on CT scans, and a negative echocardiogram for endocarditis. A bronchoscopy showed no evidence of a source from the lungs, and specimens taken from the pleural adhesions were negative for malignancy and bacteria.
This patient had risk factors for the illness, namely his history of being immunocompromised secondary to myelodysplastic syndrome.7 Accordingly, the patient showed persistent leukopenia with neutropenia and lymphocytopenia, which would not be expected for most patients with such an extensive infection. 8 While being immunocompromised undoubtedly contributed to the severity of the patient’s presentation and slow recovery, it does not explain the etiology or origin of his infection. This patient differs from current literature in that his splenic abscess was truly idiopathic rather than resulting from an alternative source.
Complications of splenic abscesses include pleural effusions, as seen with this patient, as well as pneumonia, pneumothorax, hemorrhage, subphrenic abscess, and intraabdominal perforation, among others.2 We determined conclusively that the patient’s pleural effusion was secondary to the splenic abscess, and excluded other bacterial foci strongly suggests that the spleen was the origin of the illness.
CONCLUSIONS
This case suggests splenic abscesses should be considered when evaluating pleural effusion. It further demonstrates that the spleen may be the central source of infection in the absence of iatrogenic inoculation or bacteremia. We hope our findings may lead to earlier identification in similar scenarios and improved patient outcomes in a multidisciplinary approach.
Splenic abscesses are a rare occurrence that represent a marginal proportion of intra-abdominal infections. One study found splenic abscesses in only 0.14% to 0.70% of autopsies and none of the 540 abdominal abscesses they examined originated in the spleen.1 Patients with splenic abscesses tend to present with nonspecific symptoms such as fevers, chills, and abdominal pain.2 Imaging modalities such as abdominal ultrasound and computed tomography (CT) are vital to the workup and diagnosis identification.2 Splenic abscesses are generally associated with another underlying process, as seen in patients who are affected by endocarditis, trauma, metastatic infection, splenic infarction, or neoplasia.2
Pleural effusions, or the buildup of fluid within the pleural space, is a common condition typically secondary to another disease.3 Clinical identification of the primary condition may be challenging.3 In the absence of a clear etiology, such as obvious signs of congestive heart failure, further differentiation relies upon pleural fluid analysis, beginning with the distinction between exudate (inflammatory) and transudate (noninflammatory). 3,4 This distinction can be made using Light’s criteria, which relies on protein and lactate dehydrogenase (LDH) ratios between the pleural fluid and serum (Table 1).5 Though rare, half of splenic abscesses are associated with pleural effusion.6 As an inflammatory condition, splenic abscesses have been classically described as a cause of exudative pleural effusions.5,6
A myelodysplastic syndrome is a group of diseases that arise from malignant hematopoietic stem cells, leading to the proliferation of the malignant cells and faulty production of other bone marrow products.7 These disorders can range from single to multilineage dysplasia. Cells are often left in an immature blast form, unable to function appropriately, and vulnerable to destruction. Patients with myeloproliferative disorders frequently suffer from leukopenia and infections attributable to known quantitative and qualitative defects of neutrophils.8
CASE PRESENTATION
A male aged 80 years presented to the Central Texas Veterans Affairs Hospital (CTVAH) with shortness of breath, weight loss, and fever. On admission, his medical history was notable for atrial fibrillation, myelodysplastic syndrome, hypertension, hyperlipidemia, stable ascending aortic aneurysm, and Vitamin B12 deficiency. A chest CT showed a large left pleural effusion (Figure 1). Additionally, the radiology report noted a nonspecific 4- to 5-cm lobulated subdiaphragmatic mass within the anterior dome of the spleen with surrounding soft tissue swelling and splenomegaly (Figure 2).
Initial thoracentesis was performed with 1500 mL of straw-colored fluid negative for bacteria, fungi, malignancy, and acid-fast organisms (Tables 2 and 3). The pleural effusion persisted, requiring a second thoracentesis 2 days later that was positive for Escherichia coli (E coli). Given the exudative nature and positive culture, a chest tube was placed, and the pleural effusion was therefore felt to be an empyema, arousing suspicion that the splenic mass seen on CT was an abscess. The site was accessed by interventional radiology, purulent fluid aspirated, and a drain was placed. Cultures grew E coli sensitive to ceftriaxone. Despite receiving intravenous ceftriaxone 2 g daily, the pleural effusion became further complicated due to chest tube obstruction and persistent drainage.
The patient was discharged to Baylor Scott & White Medical Center in Temple, Texas where he underwent decortication with cardiothoracic surgery with several pleural adhesions noted. Following surgery the patient was readmitted to CTVAH and continued ceftriaxone therapy following the infectious disease specialist's recommendation. He was discharged with plans to return to CTVAH for continued care. The patient was readmitted and transitioned to oral levofloxacin 500 mg daily and received physical and occupational therapy. He showed dramatic improvement on this regimen, with a 3-week follow-up CT that indicated only a small left pleural effusion and a 28 mm × 11 mm × 10 mm lesion in the anterior superior spleen. The patient had not returned for further evaluation by thoracic surgery; however, he has continued to see CTVAH primary care without reported recurrence of symptoms.
DISCUSSION
Splenic abscesses are a rare condition typically characterized by hematogenous spread of bacteria from another source, most commonly the endocardium.2 Other differential diagnoses include bacteremia or spread from an intra-abdominal site.2 Staphylococcus aureus and E coli are the most common bacteria seen in splenic abscesses. 2 Treatment includes antibiotics, percutaneous drainage, and, as a last resort, splenectomy.2
Our patient was found to have grown E coli, but no source indicative of spread was identified. He had negative blood cultures, negative findings for intra-abdominal pathologies on CT scans, and a negative echocardiogram for endocarditis. A bronchoscopy showed no evidence of a source from the lungs, and specimens taken from the pleural adhesions were negative for malignancy and bacteria.
This patient had risk factors for the illness, namely his history of being immunocompromised secondary to myelodysplastic syndrome.7 Accordingly, the patient showed persistent leukopenia with neutropenia and lymphocytopenia, which would not be expected for most patients with such an extensive infection. 8 While being immunocompromised undoubtedly contributed to the severity of the patient’s presentation and slow recovery, it does not explain the etiology or origin of his infection. This patient differs from current literature in that his splenic abscess was truly idiopathic rather than resulting from an alternative source.
Complications of splenic abscesses include pleural effusions, as seen with this patient, as well as pneumonia, pneumothorax, hemorrhage, subphrenic abscess, and intraabdominal perforation, among others.2 We determined conclusively that the patient’s pleural effusion was secondary to the splenic abscess, and excluded other bacterial foci strongly suggests that the spleen was the origin of the illness.
CONCLUSIONS
This case suggests splenic abscesses should be considered when evaluating pleural effusion. It further demonstrates that the spleen may be the central source of infection in the absence of iatrogenic inoculation or bacteremia. We hope our findings may lead to earlier identification in similar scenarios and improved patient outcomes in a multidisciplinary approach.
- Lee WS, Choi ST, Kim KK. Splenic abscess: a single institution study and review of the literature. Yonsei Med J. 2011;52(2):288-292. doi:10.3349/ymj.2011.52.2.288
- Lotfollahzadeh S, Mathew G, Zemaitis MR. Splenic Abscess. In: StatPearls. StatPearls Publishing; June 3, 2023.
- Jany B, Welte T. Pleural effusion in adults-etiology, diagnosis, and treatment. Dtsch Arztebl Int. 2019;116(21):377- 386. doi:10.3238/arztebl.2019.0377
- Light RW. Pleural effusions. Med Clin North Am. 2011;95(6):1055-1070. doi:10.1016/j.mcna.2011.08.005
- Feller-Kopman D, Light R. Pleural Disease. N Engl J Med. 2018;378(18):1754. doi:10.1056/NEJMc1803858
- Ferreiro L, Casal A, Toubes ME, et al. Pleural effusion due to nonmalignant gastrointestinal disease. ERJ Open Res. 2023;9(3):00290-2022. doi:10.1183/23120541.00290-2022
- Hasserjian RP. Myelodysplastic syndrome updated. Pathobiology. 2019;86(1):7-13. doi:10.1159/000489702
- Toma A, Fenaux P, Dreyfus F, Cordonnier C. Infections in myelodysplastic syndromes. Haematologica. 2012;97(10):1459- 1470. doi:10.3324/haematol2012.063420
- Lee WS, Choi ST, Kim KK. Splenic abscess: a single institution study and review of the literature. Yonsei Med J. 2011;52(2):288-292. doi:10.3349/ymj.2011.52.2.288
- Lotfollahzadeh S, Mathew G, Zemaitis MR. Splenic Abscess. In: StatPearls. StatPearls Publishing; June 3, 2023.
- Jany B, Welte T. Pleural effusion in adults-etiology, diagnosis, and treatment. Dtsch Arztebl Int. 2019;116(21):377- 386. doi:10.3238/arztebl.2019.0377
- Light RW. Pleural effusions. Med Clin North Am. 2011;95(6):1055-1070. doi:10.1016/j.mcna.2011.08.005
- Feller-Kopman D, Light R. Pleural Disease. N Engl J Med. 2018;378(18):1754. doi:10.1056/NEJMc1803858
- Ferreiro L, Casal A, Toubes ME, et al. Pleural effusion due to nonmalignant gastrointestinal disease. ERJ Open Res. 2023;9(3):00290-2022. doi:10.1183/23120541.00290-2022
- Hasserjian RP. Myelodysplastic syndrome updated. Pathobiology. 2019;86(1):7-13. doi:10.1159/000489702
- Toma A, Fenaux P, Dreyfus F, Cordonnier C. Infections in myelodysplastic syndromes. Haematologica. 2012;97(10):1459- 1470. doi:10.3324/haematol2012.063420
FDA Expands Indication for Amivantamab in Lung Cancer
Amivantamab with carboplatin and pemetrexed is now indicated for adults with locally advanced or metastatic NSCLC with EGFR exon 19 deletions or exon 21 L858R substitution mutations whose disease has progressed on or after treatment with an EGFR tyrosine kinase inhibitor (TKI).
The FDA has already approved first-line use of amivantamab in combination with carboplatin and pemetrexed in patients with locally advanced or metastatic NSCLC with EGFR exon 20 insertion mutations, as reported by Medscape Medical News.
The second-line approval for amivantamab plus chemotherapy “may address the most common mechanisms of treatment resistance to third-generation EGFR TKIs, such as osimertinib, in the first line,” Martin Dietrich, MD, PhD, oncologist, Cancer Care Centers of Brevard in Florida, said in a company news release.
“This multitargeted combination extended progression-free survival (PFS) and improved overall response compared to chemotherapy alone, offering an important and effective new second-line option for patients,” Dr. Dietrich added.
The second-line indication is supported by the phase 3 MARIPOSA-2 study, which included 657 patients with locally advanced or metastatic NSCLC with EGFR exon 19 deletions or exon 21 L858R substitution mutations and disease progression on or after receiving osimertinib.
The study demonstrated a 52% reduced risk of disease progression or death when amivantamab was added to carboplatin and pemetrexed (hazard ratio, 0.48).
Median PFS was 6.3 months with amivantamab vs 4.2 months with chemotherapy alone. The confirmed objective response rate was 53% in the amivantamab plus chemotherapy group vs 29% in the chemotherapy only group.
The most common adverse reactions, occurring in at least 20% of patients, were rash, infusion-related reactions, fatigue, nail toxicity, nausea, constipation, edema, stomatitis, decreased appetite, musculoskeletal pain, vomiting, and COVID-19 infection.
The company noted that amivantamab in combination with chemotherapy is the only category 1 treatment option in National Comprehensive Cancer Network clinical practice guidelines for patients with EGFR-mutated NSCLC who have progressed on osimertinib and who are symptomatic with multiple lesions.
A version of this article appeared on Medscape.com.
Amivantamab with carboplatin and pemetrexed is now indicated for adults with locally advanced or metastatic NSCLC with EGFR exon 19 deletions or exon 21 L858R substitution mutations whose disease has progressed on or after treatment with an EGFR tyrosine kinase inhibitor (TKI).
The FDA has already approved first-line use of amivantamab in combination with carboplatin and pemetrexed in patients with locally advanced or metastatic NSCLC with EGFR exon 20 insertion mutations, as reported by Medscape Medical News.
The second-line approval for amivantamab plus chemotherapy “may address the most common mechanisms of treatment resistance to third-generation EGFR TKIs, such as osimertinib, in the first line,” Martin Dietrich, MD, PhD, oncologist, Cancer Care Centers of Brevard in Florida, said in a company news release.
“This multitargeted combination extended progression-free survival (PFS) and improved overall response compared to chemotherapy alone, offering an important and effective new second-line option for patients,” Dr. Dietrich added.
The second-line indication is supported by the phase 3 MARIPOSA-2 study, which included 657 patients with locally advanced or metastatic NSCLC with EGFR exon 19 deletions or exon 21 L858R substitution mutations and disease progression on or after receiving osimertinib.
The study demonstrated a 52% reduced risk of disease progression or death when amivantamab was added to carboplatin and pemetrexed (hazard ratio, 0.48).
Median PFS was 6.3 months with amivantamab vs 4.2 months with chemotherapy alone. The confirmed objective response rate was 53% in the amivantamab plus chemotherapy group vs 29% in the chemotherapy only group.
The most common adverse reactions, occurring in at least 20% of patients, were rash, infusion-related reactions, fatigue, nail toxicity, nausea, constipation, edema, stomatitis, decreased appetite, musculoskeletal pain, vomiting, and COVID-19 infection.
The company noted that amivantamab in combination with chemotherapy is the only category 1 treatment option in National Comprehensive Cancer Network clinical practice guidelines for patients with EGFR-mutated NSCLC who have progressed on osimertinib and who are symptomatic with multiple lesions.
A version of this article appeared on Medscape.com.
Amivantamab with carboplatin and pemetrexed is now indicated for adults with locally advanced or metastatic NSCLC with EGFR exon 19 deletions or exon 21 L858R substitution mutations whose disease has progressed on or after treatment with an EGFR tyrosine kinase inhibitor (TKI).
The FDA has already approved first-line use of amivantamab in combination with carboplatin and pemetrexed in patients with locally advanced or metastatic NSCLC with EGFR exon 20 insertion mutations, as reported by Medscape Medical News.
The second-line approval for amivantamab plus chemotherapy “may address the most common mechanisms of treatment resistance to third-generation EGFR TKIs, such as osimertinib, in the first line,” Martin Dietrich, MD, PhD, oncologist, Cancer Care Centers of Brevard in Florida, said in a company news release.
“This multitargeted combination extended progression-free survival (PFS) and improved overall response compared to chemotherapy alone, offering an important and effective new second-line option for patients,” Dr. Dietrich added.
The second-line indication is supported by the phase 3 MARIPOSA-2 study, which included 657 patients with locally advanced or metastatic NSCLC with EGFR exon 19 deletions or exon 21 L858R substitution mutations and disease progression on or after receiving osimertinib.
The study demonstrated a 52% reduced risk of disease progression or death when amivantamab was added to carboplatin and pemetrexed (hazard ratio, 0.48).
Median PFS was 6.3 months with amivantamab vs 4.2 months with chemotherapy alone. The confirmed objective response rate was 53% in the amivantamab plus chemotherapy group vs 29% in the chemotherapy only group.
The most common adverse reactions, occurring in at least 20% of patients, were rash, infusion-related reactions, fatigue, nail toxicity, nausea, constipation, edema, stomatitis, decreased appetite, musculoskeletal pain, vomiting, and COVID-19 infection.
The company noted that amivantamab in combination with chemotherapy is the only category 1 treatment option in National Comprehensive Cancer Network clinical practice guidelines for patients with EGFR-mutated NSCLC who have progressed on osimertinib and who are symptomatic with multiple lesions.
A version of this article appeared on Medscape.com.
Cancer Risk: Are Pesticides the New Smoking?
Pesticides have transformed modern agriculture by boosting production yields and helping alleviate food insecurity amid rapid global population growth. However, from a public health perspective, exposure to pesticides has been linked to numerous harmful effects, including neurologic disorders like Parkinson’s disease, weakened immune function, and an increased risk for cancer.
thus offering a limited perspective.
A comprehensive assessment of how pesticide use affects cancer risk across a broader population has yet to be conducted.
A recent population-level study aimed to address this gap by evaluating cancer risks in the US population using a model that accounts for pesticide use and adjusts for various factors. The goal was to identify regional disparities in exposure and contribute to the development of public health policies that protect populations from potential harm.
Calculating Cancer Risk
Researchers developed a model using several data sources to estimate the additional cancer risk from agricultural pesticide use. Key data included:
- Pesticide use data from the US Geological Survey in 2019, which covered 69 agricultural pesticides across 3143 counties
- Cancer incidence rates per 100,000 people, which were collected between 2015 and 2019 by the National Institutes of Health and the Centers for Disease Control and Prevention; these data covered various cancers, including bladder, colorectal, leukemia, lung, non-Hodgkin lymphoma, and pancreatic cancers
- Covariates, including smoking prevalence, the Social Vulnerability Index, agricultural land use, and total US population in 2019
Pesticide use profile patterns were developed using latent class analysis, a statistical method used to identify homogeneous subgroups within a heterogeneous population. A generalized linear model then estimated how these pesticide use patterns and the covariates affected cancer incidence.
The model highlighted regions with the highest and lowest “additional” cancer risks linked to pesticide exposure, calculating the estimated increase in cancer cases per year that resulted from variations in agricultural pesticide use.
Midwest Most Affected
While this model doesn’t establish causality or assess individual risk, it reveals regional trends in the association between pesticide use patterns and cancer incidence from a population-based perspective.
The Midwest, known for its high corn production, emerged as the region most affected by pesticide use. Compared with regions with the lowest risk, the Midwest faced an additional 154,541 cancer cases annually across all types. For colorectal and pancreatic cancers, the yearly increases were 20,927 and 3835 cases, respectively. Similar trends were observed for leukemia and non-Hodgkin lymphoma.
Pesticides vs Smoking
The researchers also estimated the additional cancer risk related to smoking, using the same model. They found that pesticides contributed to a higher risk for cancer than smoking in several cases.
The most significant difference was observed with non-Hodgkin lymphoma, where pesticides were linked to 154.1% more cases than smoking. For all cancers combined, as well as bladder cancer and leukemia, the increases were moderate: 18.7%, 19.3%, and 21.0%, respectively.
This result highlights the importance of considering pesticide exposure alongside smoking when studying cancer risks.
Expanding Scope of Research
Some limitations of this study should be noted. Certain counties lacked complete data, and there was heterogeneity in the size and population of the counties studied. The research also did not account for seasonal and migrant workers, who are likely to be heavily exposed. In addition, the data used in the study were not independently validated, and they could not be used to assess individual risk.
The effect of pesticides on human health is a vast and critical field of research, often focusing on a limited range of pesticides or specific cancers. This study stands out by taking a broader, more holistic approach, aiming to highlight regional inequalities and identify less-studied pesticides that could be future research priorities.
Given the significant public health impact, the authors encouraged the authorities to share these findings with the most vulnerable communities to raise awareness.
This story was translated from JIM using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication. A version of this article appeared on Medscape.com.
Pesticides have transformed modern agriculture by boosting production yields and helping alleviate food insecurity amid rapid global population growth. However, from a public health perspective, exposure to pesticides has been linked to numerous harmful effects, including neurologic disorders like Parkinson’s disease, weakened immune function, and an increased risk for cancer.
thus offering a limited perspective.
A comprehensive assessment of how pesticide use affects cancer risk across a broader population has yet to be conducted.
A recent population-level study aimed to address this gap by evaluating cancer risks in the US population using a model that accounts for pesticide use and adjusts for various factors. The goal was to identify regional disparities in exposure and contribute to the development of public health policies that protect populations from potential harm.
Calculating Cancer Risk
Researchers developed a model using several data sources to estimate the additional cancer risk from agricultural pesticide use. Key data included:
- Pesticide use data from the US Geological Survey in 2019, which covered 69 agricultural pesticides across 3143 counties
- Cancer incidence rates per 100,000 people, which were collected between 2015 and 2019 by the National Institutes of Health and the Centers for Disease Control and Prevention; these data covered various cancers, including bladder, colorectal, leukemia, lung, non-Hodgkin lymphoma, and pancreatic cancers
- Covariates, including smoking prevalence, the Social Vulnerability Index, agricultural land use, and total US population in 2019
Pesticide use profile patterns were developed using latent class analysis, a statistical method used to identify homogeneous subgroups within a heterogeneous population. A generalized linear model then estimated how these pesticide use patterns and the covariates affected cancer incidence.
The model highlighted regions with the highest and lowest “additional” cancer risks linked to pesticide exposure, calculating the estimated increase in cancer cases per year that resulted from variations in agricultural pesticide use.
Midwest Most Affected
While this model doesn’t establish causality or assess individual risk, it reveals regional trends in the association between pesticide use patterns and cancer incidence from a population-based perspective.
The Midwest, known for its high corn production, emerged as the region most affected by pesticide use. Compared with regions with the lowest risk, the Midwest faced an additional 154,541 cancer cases annually across all types. For colorectal and pancreatic cancers, the yearly increases were 20,927 and 3835 cases, respectively. Similar trends were observed for leukemia and non-Hodgkin lymphoma.
Pesticides vs Smoking
The researchers also estimated the additional cancer risk related to smoking, using the same model. They found that pesticides contributed to a higher risk for cancer than smoking in several cases.
The most significant difference was observed with non-Hodgkin lymphoma, where pesticides were linked to 154.1% more cases than smoking. For all cancers combined, as well as bladder cancer and leukemia, the increases were moderate: 18.7%, 19.3%, and 21.0%, respectively.
This result highlights the importance of considering pesticide exposure alongside smoking when studying cancer risks.
Expanding Scope of Research
Some limitations of this study should be noted. Certain counties lacked complete data, and there was heterogeneity in the size and population of the counties studied. The research also did not account for seasonal and migrant workers, who are likely to be heavily exposed. In addition, the data used in the study were not independently validated, and they could not be used to assess individual risk.
The effect of pesticides on human health is a vast and critical field of research, often focusing on a limited range of pesticides or specific cancers. This study stands out by taking a broader, more holistic approach, aiming to highlight regional inequalities and identify less-studied pesticides that could be future research priorities.
Given the significant public health impact, the authors encouraged the authorities to share these findings with the most vulnerable communities to raise awareness.
This story was translated from JIM using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication. A version of this article appeared on Medscape.com.
Pesticides have transformed modern agriculture by boosting production yields and helping alleviate food insecurity amid rapid global population growth. However, from a public health perspective, exposure to pesticides has been linked to numerous harmful effects, including neurologic disorders like Parkinson’s disease, weakened immune function, and an increased risk for cancer.
thus offering a limited perspective.
A comprehensive assessment of how pesticide use affects cancer risk across a broader population has yet to be conducted.
A recent population-level study aimed to address this gap by evaluating cancer risks in the US population using a model that accounts for pesticide use and adjusts for various factors. The goal was to identify regional disparities in exposure and contribute to the development of public health policies that protect populations from potential harm.
Calculating Cancer Risk
Researchers developed a model using several data sources to estimate the additional cancer risk from agricultural pesticide use. Key data included:
- Pesticide use data from the US Geological Survey in 2019, which covered 69 agricultural pesticides across 3143 counties
- Cancer incidence rates per 100,000 people, which were collected between 2015 and 2019 by the National Institutes of Health and the Centers for Disease Control and Prevention; these data covered various cancers, including bladder, colorectal, leukemia, lung, non-Hodgkin lymphoma, and pancreatic cancers
- Covariates, including smoking prevalence, the Social Vulnerability Index, agricultural land use, and total US population in 2019
Pesticide use profile patterns were developed using latent class analysis, a statistical method used to identify homogeneous subgroups within a heterogeneous population. A generalized linear model then estimated how these pesticide use patterns and the covariates affected cancer incidence.
The model highlighted regions with the highest and lowest “additional” cancer risks linked to pesticide exposure, calculating the estimated increase in cancer cases per year that resulted from variations in agricultural pesticide use.
Midwest Most Affected
While this model doesn’t establish causality or assess individual risk, it reveals regional trends in the association between pesticide use patterns and cancer incidence from a population-based perspective.
The Midwest, known for its high corn production, emerged as the region most affected by pesticide use. Compared with regions with the lowest risk, the Midwest faced an additional 154,541 cancer cases annually across all types. For colorectal and pancreatic cancers, the yearly increases were 20,927 and 3835 cases, respectively. Similar trends were observed for leukemia and non-Hodgkin lymphoma.
Pesticides vs Smoking
The researchers also estimated the additional cancer risk related to smoking, using the same model. They found that pesticides contributed to a higher risk for cancer than smoking in several cases.
The most significant difference was observed with non-Hodgkin lymphoma, where pesticides were linked to 154.1% more cases than smoking. For all cancers combined, as well as bladder cancer and leukemia, the increases were moderate: 18.7%, 19.3%, and 21.0%, respectively.
This result highlights the importance of considering pesticide exposure alongside smoking when studying cancer risks.
Expanding Scope of Research
Some limitations of this study should be noted. Certain counties lacked complete data, and there was heterogeneity in the size and population of the counties studied. The research also did not account for seasonal and migrant workers, who are likely to be heavily exposed. In addition, the data used in the study were not independently validated, and they could not be used to assess individual risk.
The effect of pesticides on human health is a vast and critical field of research, often focusing on a limited range of pesticides or specific cancers. This study stands out by taking a broader, more holistic approach, aiming to highlight regional inequalities and identify less-studied pesticides that could be future research priorities.
Given the significant public health impact, the authors encouraged the authorities to share these findings with the most vulnerable communities to raise awareness.
This story was translated from JIM using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication. A version of this article appeared on Medscape.com.
Benralizumab Now FDA Approved to Treat EGPA Vasculitis
The Food and Drug Administration (FDA) has approved benralizumab (Fasenra) for the treatment of adults with eosinophilic granulomatosis with polyangiitis (EGPA), formerly known as Churg-Strauss syndrome.
The drug is the second approved biologic for the treatment of EGPA. The first, mepolizumab (Nucala), was approved in 2017.
“This disease has a devastating impact on patients and the quality of their life, and they need more treatment options. The approval of another treatment in EGPA is welcome news to the approximately 15,000 patients living in the US with this difficult-to-treat rare disease,” said Joyce Kullman, executive director of the Vasculitis Foundation, in a press release on September 18.
Benralizumab, developed by AstraZeneca, is a monoclonal antibody against the interleukin-5 alpha receptor expressed on eosinophils. The drug was first approved in 2017 as an add-on treatment for patients 12 years and older with severe eosinophilic asthma, and is now approved for use in children aged 6 years and older.
The new indication was based on positive results from a noninferiority trial comparing benralizumab and mepolizumab. For the trial, published in the New England Journal of Medicine earlier in 2024, 140 adults with relapsing or refractory EGPA were randomized to a 30-mg subcutaneous injection of benralizumab or three separate 100-mg mepolizumab injections every 4 weeks for 1 year. At weeks 36 and 48, 59% of patients in the benralizumab group and 56% of patients in the mepolizumab group achieved remission (95% CI, –13 to 18; P = .73 for superiority). From week 42 to 52, 41% of patients who received benralizumab completely stopped taking oral glucocorticoids, compared with 26% of those who received mepolizumab.
“Patients often rely on long-term oral corticosteroids, which can cause serious and lasting side effects. Benralizumab is a much-needed treatment option, with data showing that not only is remission an achievable goal for EGPA patients, but benralizumab can also help patients taper off steroid therapy,” Michael Wechsler, MD, director of The Asthma Institute at National Jewish Health in Denver, Colorado, and the international coordinating investigator for the clinical trial, said in the press release.
Benralizumab is administered via subcutaneous injection. In adults with EGPA, the recommended dosage is 30 mg every 4 weeks for the first three doses, then once every 8 weeks.
The most common adverse reactions include headache and pharyngitis, according to the prescribing information.
Benralizumab is also in development for the treatment of chronic obstructive pulmonary disease, chronic rhinosinusitis with nasal polyps, and hypereosinophilic syndrome.
A version of this article first appeared on Medscape.com.
The Food and Drug Administration (FDA) has approved benralizumab (Fasenra) for the treatment of adults with eosinophilic granulomatosis with polyangiitis (EGPA), formerly known as Churg-Strauss syndrome.
The drug is the second approved biologic for the treatment of EGPA. The first, mepolizumab (Nucala), was approved in 2017.
“This disease has a devastating impact on patients and the quality of their life, and they need more treatment options. The approval of another treatment in EGPA is welcome news to the approximately 15,000 patients living in the US with this difficult-to-treat rare disease,” said Joyce Kullman, executive director of the Vasculitis Foundation, in a press release on September 18.
Benralizumab, developed by AstraZeneca, is a monoclonal antibody against the interleukin-5 alpha receptor expressed on eosinophils. The drug was first approved in 2017 as an add-on treatment for patients 12 years and older with severe eosinophilic asthma, and is now approved for use in children aged 6 years and older.
The new indication was based on positive results from a noninferiority trial comparing benralizumab and mepolizumab. For the trial, published in the New England Journal of Medicine earlier in 2024, 140 adults with relapsing or refractory EGPA were randomized to a 30-mg subcutaneous injection of benralizumab or three separate 100-mg mepolizumab injections every 4 weeks for 1 year. At weeks 36 and 48, 59% of patients in the benralizumab group and 56% of patients in the mepolizumab group achieved remission (95% CI, –13 to 18; P = .73 for superiority). From week 42 to 52, 41% of patients who received benralizumab completely stopped taking oral glucocorticoids, compared with 26% of those who received mepolizumab.
“Patients often rely on long-term oral corticosteroids, which can cause serious and lasting side effects. Benralizumab is a much-needed treatment option, with data showing that not only is remission an achievable goal for EGPA patients, but benralizumab can also help patients taper off steroid therapy,” Michael Wechsler, MD, director of The Asthma Institute at National Jewish Health in Denver, Colorado, and the international coordinating investigator for the clinical trial, said in the press release.
Benralizumab is administered via subcutaneous injection. In adults with EGPA, the recommended dosage is 30 mg every 4 weeks for the first three doses, then once every 8 weeks.
The most common adverse reactions include headache and pharyngitis, according to the prescribing information.
Benralizumab is also in development for the treatment of chronic obstructive pulmonary disease, chronic rhinosinusitis with nasal polyps, and hypereosinophilic syndrome.
A version of this article first appeared on Medscape.com.
The Food and Drug Administration (FDA) has approved benralizumab (Fasenra) for the treatment of adults with eosinophilic granulomatosis with polyangiitis (EGPA), formerly known as Churg-Strauss syndrome.
The drug is the second approved biologic for the treatment of EGPA. The first, mepolizumab (Nucala), was approved in 2017.
“This disease has a devastating impact on patients and the quality of their life, and they need more treatment options. The approval of another treatment in EGPA is welcome news to the approximately 15,000 patients living in the US with this difficult-to-treat rare disease,” said Joyce Kullman, executive director of the Vasculitis Foundation, in a press release on September 18.
Benralizumab, developed by AstraZeneca, is a monoclonal antibody against the interleukin-5 alpha receptor expressed on eosinophils. The drug was first approved in 2017 as an add-on treatment for patients 12 years and older with severe eosinophilic asthma, and is now approved for use in children aged 6 years and older.
The new indication was based on positive results from a noninferiority trial comparing benralizumab and mepolizumab. For the trial, published in the New England Journal of Medicine earlier in 2024, 140 adults with relapsing or refractory EGPA were randomized to a 30-mg subcutaneous injection of benralizumab or three separate 100-mg mepolizumab injections every 4 weeks for 1 year. At weeks 36 and 48, 59% of patients in the benralizumab group and 56% of patients in the mepolizumab group achieved remission (95% CI, –13 to 18; P = .73 for superiority). From week 42 to 52, 41% of patients who received benralizumab completely stopped taking oral glucocorticoids, compared with 26% of those who received mepolizumab.
“Patients often rely on long-term oral corticosteroids, which can cause serious and lasting side effects. Benralizumab is a much-needed treatment option, with data showing that not only is remission an achievable goal for EGPA patients, but benralizumab can also help patients taper off steroid therapy,” Michael Wechsler, MD, director of The Asthma Institute at National Jewish Health in Denver, Colorado, and the international coordinating investigator for the clinical trial, said in the press release.
Benralizumab is administered via subcutaneous injection. In adults with EGPA, the recommended dosage is 30 mg every 4 weeks for the first three doses, then once every 8 weeks.
The most common adverse reactions include headache and pharyngitis, according to the prescribing information.
Benralizumab is also in development for the treatment of chronic obstructive pulmonary disease, chronic rhinosinusitis with nasal polyps, and hypereosinophilic syndrome.
A version of this article first appeared on Medscape.com.
Rheumatology Clinic Interventions for Smoking, Blood Pressure ‘Make a Big Difference’
Two relatively simple interventions — addressing high blood pressure (BP) and smoking cessation — could make a huge difference for patients with rheumatic disease. Patients with autoimmune disease are up to three times more likely to develop cardiovascular disease (CVD) than the general population. In addition to compounding CVD, smoking is tied to the development of certain autoimmune conditions, as well as worse outcomes. Christie Bartels, MD, chief of the Division of Rheumatology at the University of Wisconsin School of Medicine and Public Health, Madison, has focused her research on improving cardiac health in inflammatory diseases. This news organization spoke with Bartels about two short interventions she developed that tackle hypertension and smoking cessation during regular visits, each taking less than 3 minutes.
How Do These Programs Address Cardiac Disease Prevention?
The BP and Quit Connect programs help clinics systematically address the two most modifiable risk factors for CVD: high BP and smoking. There’s also evidence that addressing these two risk factors improves outcomes in rheumatic diseases. Hypertension predicts an increase in lupus damage. Particularly in lupus nephritis, hypertension will increase the risk for CVD and kidney failure. People who use tobacco have worse outcomes in diseases like rheumatoid arthritis, psoriatic arthritis, and lupus, as well as more CVD, and antirheumatic drugs may not work as well.
In 90 seconds to 3 minutes, staff can do protocol-based care, which we’ve done across 20,000-plus visits. We showed we can improve population level rates of high BP and BP control, as well as increase smoking quitting rates across different patient settings.
What Is the Quit Connect Program?
The Quit Connect program is a 10- to 90-second point of care intervention. During rooming, staff (medical assistants and nurses) ask patients: “A) Do you smoke? and B) Have you thought about cutting back or quitting in the next 30 days?”
It turns out, when you ask the question that way, between a third and a half of people say that they’ve thought about cutting back or quitting. Then, we can get patients connected directly to Quitline, a free public service across all 50 states that smokers can use to get cessation support.
If patients are ready, we ask if we can arrange for them to receive a call from a Quitline coach about setting a quit date or receiving free nicotine replacement therapy. The beautiful thing is when that all happens, A) it’s free to the patient, and B) the results from the Quitline can be recorded right back to the electronic health record.
In our most recent publication in Arthritis Care & Research, we documented bringing Quit Connect to Grady Hospital in downtown Atlanta. It’s a safety net hospital, where 80% patients are Black and 70%-80% patients are on public insurance or uninsured. Using this protocol, we improved Quitline referrals 20-fold.
What Is the BP Connect Program?
At least half of the encounters in United States happen in specialty clinics. Unfortunately, when patients get their BP measured in a specialty clinic that’s not a cardiology or a vascular clinic, often, even if the pressure is high, the clinic doesn’t give patients feedback on that. The problem is because we haven’t said anything, that gives people the false reassurance that their BP is okay.
We’ve developed a 3-minute protocol to ask, advise, and connect. The idea is that if we measure a high BP, then we remeasure and confirm that it’s high. Then, we advise why it matters in rheumatic disease: Patients with rheumatic diseases are already at an increased risk for heart disease, and controlling BP can make a big difference. Then, we connect patients with high BP back to primary care.
Specifically, a SmartSet — an electronic medical record feature — prompts different actions based on confirmed high BP readings:
- If systolic BP ≥ 140-159, the SmartSet directs scheduling a visit to a nurse or primary care provider.
- If systolic BP ≥ 160-179, the next primary care visit anticipates the need to see a prescriber.
- If systolic BP ≥ 180, then the medical assistant or nurse at the visit is instructed to notify the provider who can arrange a provider-to-provider handoff for safety to exclude a hypertensive emergency.
That order goes to the scheduler to call primary care to coordinate follow-up. BP Connect doubled the likelihood of a guideline-recommended follow-up in primary care within 30 days. All patients benefited, and disparities decreased. BP Connect has had 1100 downloads, and both BP and Quit Connect programs are endorsed by the Centers for Disease Control and Prevention and Million Hearts.
How Do These Programs Affect Clinical Practice?
We developed these interventions with a health system engineer, and we time stamped everything. Part of the sustainability of this model is that it fits within a regular workflow. As a practicing rheumatologist, I understand that time is a precious commodity.
The interventions are in partnership with frontline staff. We’ve received feedback that they feel pride participating in these initiatives. They can say, because of me, 30 patients followed up last month for high BP, or 10 patients took a referral to the Quitline last year. We celebrate these accomplishments with the staff.
What Are the Next Steps for These Programs?
Public-facing toolkits for both BP and Quit Connect programs are available online. We have implemented [these programs] in a rural setting, in an urban setting, in Milwaukee and in Atlanta, and we are looking in the future to do a larger, multistate implementation study. If folks are interested, we’d love to partner with them to look at disseminating this further.
A version of this article appeared on Medscape.com.
Two relatively simple interventions — addressing high blood pressure (BP) and smoking cessation — could make a huge difference for patients with rheumatic disease. Patients with autoimmune disease are up to three times more likely to develop cardiovascular disease (CVD) than the general population. In addition to compounding CVD, smoking is tied to the development of certain autoimmune conditions, as well as worse outcomes. Christie Bartels, MD, chief of the Division of Rheumatology at the University of Wisconsin School of Medicine and Public Health, Madison, has focused her research on improving cardiac health in inflammatory diseases. This news organization spoke with Bartels about two short interventions she developed that tackle hypertension and smoking cessation during regular visits, each taking less than 3 minutes.
How Do These Programs Address Cardiac Disease Prevention?
The BP and Quit Connect programs help clinics systematically address the two most modifiable risk factors for CVD: high BP and smoking. There’s also evidence that addressing these two risk factors improves outcomes in rheumatic diseases. Hypertension predicts an increase in lupus damage. Particularly in lupus nephritis, hypertension will increase the risk for CVD and kidney failure. People who use tobacco have worse outcomes in diseases like rheumatoid arthritis, psoriatic arthritis, and lupus, as well as more CVD, and antirheumatic drugs may not work as well.
In 90 seconds to 3 minutes, staff can do protocol-based care, which we’ve done across 20,000-plus visits. We showed we can improve population level rates of high BP and BP control, as well as increase smoking quitting rates across different patient settings.
What Is the Quit Connect Program?
The Quit Connect program is a 10- to 90-second point of care intervention. During rooming, staff (medical assistants and nurses) ask patients: “A) Do you smoke? and B) Have you thought about cutting back or quitting in the next 30 days?”
It turns out, when you ask the question that way, between a third and a half of people say that they’ve thought about cutting back or quitting. Then, we can get patients connected directly to Quitline, a free public service across all 50 states that smokers can use to get cessation support.
If patients are ready, we ask if we can arrange for them to receive a call from a Quitline coach about setting a quit date or receiving free nicotine replacement therapy. The beautiful thing is when that all happens, A) it’s free to the patient, and B) the results from the Quitline can be recorded right back to the electronic health record.
In our most recent publication in Arthritis Care & Research, we documented bringing Quit Connect to Grady Hospital in downtown Atlanta. It’s a safety net hospital, where 80% patients are Black and 70%-80% patients are on public insurance or uninsured. Using this protocol, we improved Quitline referrals 20-fold.
What Is the BP Connect Program?
At least half of the encounters in United States happen in specialty clinics. Unfortunately, when patients get their BP measured in a specialty clinic that’s not a cardiology or a vascular clinic, often, even if the pressure is high, the clinic doesn’t give patients feedback on that. The problem is because we haven’t said anything, that gives people the false reassurance that their BP is okay.
We’ve developed a 3-minute protocol to ask, advise, and connect. The idea is that if we measure a high BP, then we remeasure and confirm that it’s high. Then, we advise why it matters in rheumatic disease: Patients with rheumatic diseases are already at an increased risk for heart disease, and controlling BP can make a big difference. Then, we connect patients with high BP back to primary care.
Specifically, a SmartSet — an electronic medical record feature — prompts different actions based on confirmed high BP readings:
- If systolic BP ≥ 140-159, the SmartSet directs scheduling a visit to a nurse or primary care provider.
- If systolic BP ≥ 160-179, the next primary care visit anticipates the need to see a prescriber.
- If systolic BP ≥ 180, then the medical assistant or nurse at the visit is instructed to notify the provider who can arrange a provider-to-provider handoff for safety to exclude a hypertensive emergency.
That order goes to the scheduler to call primary care to coordinate follow-up. BP Connect doubled the likelihood of a guideline-recommended follow-up in primary care within 30 days. All patients benefited, and disparities decreased. BP Connect has had 1100 downloads, and both BP and Quit Connect programs are endorsed by the Centers for Disease Control and Prevention and Million Hearts.
How Do These Programs Affect Clinical Practice?
We developed these interventions with a health system engineer, and we time stamped everything. Part of the sustainability of this model is that it fits within a regular workflow. As a practicing rheumatologist, I understand that time is a precious commodity.
The interventions are in partnership with frontline staff. We’ve received feedback that they feel pride participating in these initiatives. They can say, because of me, 30 patients followed up last month for high BP, or 10 patients took a referral to the Quitline last year. We celebrate these accomplishments with the staff.
What Are the Next Steps for These Programs?
Public-facing toolkits for both BP and Quit Connect programs are available online. We have implemented [these programs] in a rural setting, in an urban setting, in Milwaukee and in Atlanta, and we are looking in the future to do a larger, multistate implementation study. If folks are interested, we’d love to partner with them to look at disseminating this further.
A version of this article appeared on Medscape.com.
Two relatively simple interventions — addressing high blood pressure (BP) and smoking cessation — could make a huge difference for patients with rheumatic disease. Patients with autoimmune disease are up to three times more likely to develop cardiovascular disease (CVD) than the general population. In addition to compounding CVD, smoking is tied to the development of certain autoimmune conditions, as well as worse outcomes. Christie Bartels, MD, chief of the Division of Rheumatology at the University of Wisconsin School of Medicine and Public Health, Madison, has focused her research on improving cardiac health in inflammatory diseases. This news organization spoke with Bartels about two short interventions she developed that tackle hypertension and smoking cessation during regular visits, each taking less than 3 minutes.
How Do These Programs Address Cardiac Disease Prevention?
The BP and Quit Connect programs help clinics systematically address the two most modifiable risk factors for CVD: high BP and smoking. There’s also evidence that addressing these two risk factors improves outcomes in rheumatic diseases. Hypertension predicts an increase in lupus damage. Particularly in lupus nephritis, hypertension will increase the risk for CVD and kidney failure. People who use tobacco have worse outcomes in diseases like rheumatoid arthritis, psoriatic arthritis, and lupus, as well as more CVD, and antirheumatic drugs may not work as well.
In 90 seconds to 3 minutes, staff can do protocol-based care, which we’ve done across 20,000-plus visits. We showed we can improve population level rates of high BP and BP control, as well as increase smoking quitting rates across different patient settings.
What Is the Quit Connect Program?
The Quit Connect program is a 10- to 90-second point of care intervention. During rooming, staff (medical assistants and nurses) ask patients: “A) Do you smoke? and B) Have you thought about cutting back or quitting in the next 30 days?”
It turns out, when you ask the question that way, between a third and a half of people say that they’ve thought about cutting back or quitting. Then, we can get patients connected directly to Quitline, a free public service across all 50 states that smokers can use to get cessation support.
If patients are ready, we ask if we can arrange for them to receive a call from a Quitline coach about setting a quit date or receiving free nicotine replacement therapy. The beautiful thing is when that all happens, A) it’s free to the patient, and B) the results from the Quitline can be recorded right back to the electronic health record.
In our most recent publication in Arthritis Care & Research, we documented bringing Quit Connect to Grady Hospital in downtown Atlanta. It’s a safety net hospital, where 80% patients are Black and 70%-80% patients are on public insurance or uninsured. Using this protocol, we improved Quitline referrals 20-fold.
What Is the BP Connect Program?
At least half of the encounters in United States happen in specialty clinics. Unfortunately, when patients get their BP measured in a specialty clinic that’s not a cardiology or a vascular clinic, often, even if the pressure is high, the clinic doesn’t give patients feedback on that. The problem is because we haven’t said anything, that gives people the false reassurance that their BP is okay.
We’ve developed a 3-minute protocol to ask, advise, and connect. The idea is that if we measure a high BP, then we remeasure and confirm that it’s high. Then, we advise why it matters in rheumatic disease: Patients with rheumatic diseases are already at an increased risk for heart disease, and controlling BP can make a big difference. Then, we connect patients with high BP back to primary care.
Specifically, a SmartSet — an electronic medical record feature — prompts different actions based on confirmed high BP readings:
- If systolic BP ≥ 140-159, the SmartSet directs scheduling a visit to a nurse or primary care provider.
- If systolic BP ≥ 160-179, the next primary care visit anticipates the need to see a prescriber.
- If systolic BP ≥ 180, then the medical assistant or nurse at the visit is instructed to notify the provider who can arrange a provider-to-provider handoff for safety to exclude a hypertensive emergency.
That order goes to the scheduler to call primary care to coordinate follow-up. BP Connect doubled the likelihood of a guideline-recommended follow-up in primary care within 30 days. All patients benefited, and disparities decreased. BP Connect has had 1100 downloads, and both BP and Quit Connect programs are endorsed by the Centers for Disease Control and Prevention and Million Hearts.
How Do These Programs Affect Clinical Practice?
We developed these interventions with a health system engineer, and we time stamped everything. Part of the sustainability of this model is that it fits within a regular workflow. As a practicing rheumatologist, I understand that time is a precious commodity.
The interventions are in partnership with frontline staff. We’ve received feedback that they feel pride participating in these initiatives. They can say, because of me, 30 patients followed up last month for high BP, or 10 patients took a referral to the Quitline last year. We celebrate these accomplishments with the staff.
What Are the Next Steps for These Programs?
Public-facing toolkits for both BP and Quit Connect programs are available online. We have implemented [these programs] in a rural setting, in an urban setting, in Milwaukee and in Atlanta, and we are looking in the future to do a larger, multistate implementation study. If folks are interested, we’d love to partner with them to look at disseminating this further.
A version of this article appeared on Medscape.com.
FDA OKs Subcutaneous Atezolizumab Formulation for Multiple Cancer Indications
Approved indications include non–small cell lung cancer (NSCLC), SCLC, hepatocellular carcinoma, melanoma, and alveolar soft part sarcoma. Specific indications are available with the full prescribing information at Drugs@FDA.
This is the first programmed death–ligand 1 inhibitor to gain approval for subcutaneous administration.
“This approval represents a significant option to improve the patient experience,” Ann Fish-Steagall, RN, Senior Vice President of Patient Services at the LUNGevity Foundation stated in a Genentech press release.
Subcutaneous atezolizumab and hyaluronidase-tqjs was evaluated in the open-label, randomized IMscin001 trial of 371 adult patients with locally advanced or metastatic NSCLC who were not previously exposed to cancer immunotherapy and who had disease progression following treatment with platinum-based chemotherapy. Patients were randomized 2:1 to receive subcutaneous or IV administration until disease progression or unacceptable toxicity.
Atezolizumab exposure, the primary outcome measure of the study, met the lower limit of geometric mean ratio above the prespecified threshold of 0.8 (cycle 1C trough, 1.05; area under the curve for days 0-21, 0.87).
No notable differences were observed in overall response rate, progression-free survival, or overall survival between the two formulations, according to the FDA approval notice.
The confirmed overall response rate was 9% in the subcutaneous arm and 8% intravenous arm.
Adverse events of any grade occurring in at least 10% of patients were fatigue, musculoskeletal pain, cough, dyspnea, and decreased appetite.
The recommended dose for subcutaneous injection is one 15 mL injection, which contains 1875 mg of atezolizumab and 30,000 units of hyaluronidase.
Injections should be administered in the thigh over approximately 7 minutes every 3 weeks. By contrast, IV administration generally takes 30-60 minutes.
A version of this article first appeared on Medscape.com.
Approved indications include non–small cell lung cancer (NSCLC), SCLC, hepatocellular carcinoma, melanoma, and alveolar soft part sarcoma. Specific indications are available with the full prescribing information at Drugs@FDA.
This is the first programmed death–ligand 1 inhibitor to gain approval for subcutaneous administration.
“This approval represents a significant option to improve the patient experience,” Ann Fish-Steagall, RN, Senior Vice President of Patient Services at the LUNGevity Foundation stated in a Genentech press release.
Subcutaneous atezolizumab and hyaluronidase-tqjs was evaluated in the open-label, randomized IMscin001 trial of 371 adult patients with locally advanced or metastatic NSCLC who were not previously exposed to cancer immunotherapy and who had disease progression following treatment with platinum-based chemotherapy. Patients were randomized 2:1 to receive subcutaneous or IV administration until disease progression or unacceptable toxicity.
Atezolizumab exposure, the primary outcome measure of the study, met the lower limit of geometric mean ratio above the prespecified threshold of 0.8 (cycle 1C trough, 1.05; area under the curve for days 0-21, 0.87).
No notable differences were observed in overall response rate, progression-free survival, or overall survival between the two formulations, according to the FDA approval notice.
The confirmed overall response rate was 9% in the subcutaneous arm and 8% intravenous arm.
Adverse events of any grade occurring in at least 10% of patients were fatigue, musculoskeletal pain, cough, dyspnea, and decreased appetite.
The recommended dose for subcutaneous injection is one 15 mL injection, which contains 1875 mg of atezolizumab and 30,000 units of hyaluronidase.
Injections should be administered in the thigh over approximately 7 minutes every 3 weeks. By contrast, IV administration generally takes 30-60 minutes.
A version of this article first appeared on Medscape.com.
Approved indications include non–small cell lung cancer (NSCLC), SCLC, hepatocellular carcinoma, melanoma, and alveolar soft part sarcoma. Specific indications are available with the full prescribing information at Drugs@FDA.
This is the first programmed death–ligand 1 inhibitor to gain approval for subcutaneous administration.
“This approval represents a significant option to improve the patient experience,” Ann Fish-Steagall, RN, Senior Vice President of Patient Services at the LUNGevity Foundation stated in a Genentech press release.
Subcutaneous atezolizumab and hyaluronidase-tqjs was evaluated in the open-label, randomized IMscin001 trial of 371 adult patients with locally advanced or metastatic NSCLC who were not previously exposed to cancer immunotherapy and who had disease progression following treatment with platinum-based chemotherapy. Patients were randomized 2:1 to receive subcutaneous or IV administration until disease progression or unacceptable toxicity.
Atezolizumab exposure, the primary outcome measure of the study, met the lower limit of geometric mean ratio above the prespecified threshold of 0.8 (cycle 1C trough, 1.05; area under the curve for days 0-21, 0.87).
No notable differences were observed in overall response rate, progression-free survival, or overall survival between the two formulations, according to the FDA approval notice.
The confirmed overall response rate was 9% in the subcutaneous arm and 8% intravenous arm.
Adverse events of any grade occurring in at least 10% of patients were fatigue, musculoskeletal pain, cough, dyspnea, and decreased appetite.
The recommended dose for subcutaneous injection is one 15 mL injection, which contains 1875 mg of atezolizumab and 30,000 units of hyaluronidase.
Injections should be administered in the thigh over approximately 7 minutes every 3 weeks. By contrast, IV administration generally takes 30-60 minutes.
A version of this article first appeared on Medscape.com.