Physicians continue to be the major drivers of hospital revenue, and invasive cardiologists were among the top revenue-generating specialists in 2018, according to a new survey by physician search firm Merritt Hawkins.

“The value of physician care is not only related to the quality of patient outcomes,” Travis Singleton, the company’s executive vice president, wrote in a statement. “Physicians continue to drive the financial health and viability of hospitals, even in a health care system that is evolving towards value-based payments.”

Invasive cardiologists generated an average of $3.48 million for their affiliated hospitals last year, second only to cardiovascular surgeons’ $3.70 million among the 19 specialties included in the survey. Average revenue generated by noninvasive cardiologists in 2018 came in at $2.31 million – that’s an 83% increase over the 3 years since the survey was last conducted, compared with the 42% rise seen by the invasive cardiologists over that time, Merritt Hawkins reported.


Specialist physicians as a group averaged over $2.45 million in revenue in 2018, compared with $2.13 million for primary care physicians, which “suggests that emerging value-based delivery models have yet to inhibit the revenue generating power of physician specialists,” the report said. Average revenue for all physicians in the survey was almost $2.38 million, an increase of 52% since Merritt Hawkins’ last survey.

The survey was conducted from October to December 2018 and is based on responses from 62 chief financial officers or other financial managers who represented 93 hospitals. Responses from smaller hospitals (0-99 beds) were “somewhat overrepresented in the survey” relative to their number nationwide, Merritt Hawkins said.

[email protected]

Physicians continue to be the major drivers of hospital revenue, and invasive cardiologists were among the top revenue-generating specialists in 2018, according to a new survey by physician search firm Merritt Hawkins.

“The value of physician care is not only related to the quality of patient outcomes,” Travis Singleton, the company’s executive vice president, wrote in a statement. “Physicians continue to drive the financial health and viability of hospitals, even in a health care system that is evolving towards value-based payments.”

Invasive cardiologists generated an average of $3.48 million for their affiliated hospitals last year, second only to cardiovascular surgeons’ $3.70 million among the 19 specialties included in the survey. Average revenue generated by noninvasive cardiologists in 2018 came in at $2.31 million – that’s an 83% increase over the 3 years since the survey was last conducted, compared with the 42% rise seen by the invasive cardiologists over that time, Merritt Hawkins reported.


Specialist physicians as a group averaged over $2.45 million in revenue in 2018, compared with $2.13 million for primary care physicians, which “suggests that emerging value-based delivery models have yet to inhibit the revenue generating power of physician specialists,” the report said. Average revenue for all physicians in the survey was almost $2.38 million, an increase of 52% since Merritt Hawkins’ last survey.

The survey was conducted from October to December 2018 and is based on responses from 62 chief financial officers or other financial managers who represented 93 hospitals. Responses from smaller hospitals (0-99 beds) were “somewhat overrepresented in the survey” relative to their number nationwide, Merritt Hawkins said.

[email protected]

Physicians continue to be the major drivers of hospital revenue, and invasive cardiologists were among the top revenue-generating specialists in 2018, according to a new survey by physician search firm Merritt Hawkins.

“The value of physician care is not only related to the quality of patient outcomes,” Travis Singleton, the company’s executive vice president, wrote in a statement. “Physicians continue to drive the financial health and viability of hospitals, even in a health care system that is evolving towards value-based payments.”

Invasive cardiologists generated an average of $3.48 million for their affiliated hospitals last year, second only to cardiovascular surgeons’ $3.70 million among the 19 specialties included in the survey. Average revenue generated by noninvasive cardiologists in 2018 came in at $2.31 million – that’s an 83% increase over the 3 years since the survey was last conducted, compared with the 42% rise seen by the invasive cardiologists over that time, Merritt Hawkins reported.


Specialist physicians as a group averaged over $2.45 million in revenue in 2018, compared with $2.13 million for primary care physicians, which “suggests that emerging value-based delivery models have yet to inhibit the revenue generating power of physician specialists,” the report said. Average revenue for all physicians in the survey was almost $2.38 million, an increase of 52% since Merritt Hawkins’ last survey.

The survey was conducted from October to December 2018 and is based on responses from 62 chief financial officers or other financial managers who represented 93 hospitals. Responses from smaller hospitals (0-99 beds) were “somewhat overrepresented in the survey” relative to their number nationwide, Merritt Hawkins said.

[email protected]

A proposed clinical scoring system using readily available laboratory data, rather than complex formulas, can be used to predict risk for overall survival and help with clinical decision making for patients with multiple myeloma who are ineligible for stem cell transplants, the system’s creators claim.

Peter Anderson/ Pathology Education Informational Resource Digital Library/copyright University of Alabama at Birmingham, Department of Pathology

When applied to data from two clinical trials that enrolled patients with transplant-ineligible multiple myeloma, the UK Myeloma Research Alliance Risk Profile (MRP) was shown to accurately group patients into low-, medium- and high-risk categories and was prognostic of overall survival, reported Gordon Cook, PhD, of the University of Leeds, England, and his colleagues.

“The ability of clinical scoring systems, such as that proposed here, to predict whether a patient is likely to stop treatment early because of treatment intolerability, could enable preemptive, upfront dose adjustments in patients with multiple myeloma, preventing toxicity and potentially enabling patients to stay on therapy for longer,” they wrote in the Lancet Haematology.

The investigators used data on 1,852 newly diagnosed patients recruited to the non–intensive treatment pathway of the UK’s National Cancer Research Institute Myeloma XI study (NCRI-XI, ISRCTN49407852) for a training dataset and internal validation dataset, and 520 patients recruited into the Medical Research Council Myeloma IX study (MRC-IX, ISRCTN68454111) for the test dataset.

Patient characteristics, biochemical measurements, and hematological data were plugged into univariate and multivariate models to determine their potential as prognostic variables.

The final model for the test and validation datasets included World Health Organization performance status, the multiple myeloma International Staging System, patient age, and C-reactive protein concentrations.

As noted before, the scoring algorithm groups patients into low-, medium- and high-risk categories, with each of the prognostic variables increasing in severity across the three groups in both clinical trials.

In the NCRI-XI trial, median overall survival for patients in the MRP low-risk group was 60 months, compared with 44 months in the medium-risk group, and 25 months in the high-risk group.

Similarly, in the MRC-IX trial, the respective median overall survival was 49, 34, and 20 months.

The risk groups also were associated with progression-free survival in each trial, although not as robustly as the association with overall survival.

The investigators also found that, the higher the risk group, the greater the likelihood that the median percentage of protocol dose delivered would be lower, and both a decrease in protocol dose delivered and quality of life at baseline were associated with increased risk.

The MRP categories were prognostic in patients treated with various therapeutic regimens and in patients with high-risk cytogenetics.

“None of the risk scoring systems previously developed in myeloma are dynamic, making them unable to accommodate changes in disease-related frailty that might be minimized by effective anti-myeloma therapy. There is therefore scope to improve clinical risk scores by the addition of a suitable frailty biomarker, which is currently still in developmental stages,” Dr. Cook and his colleagues wrote.

The study was funded by the Medical Research Council, Novartis, Schering Health Care, Chugai, Pharmion, Celgene, Ortho Biotech, Cancer Research UK, Celgene, Merck Sharp & Dohme, and Amgen. Dr. Cook reported grants and nonfinancial support from Celgene, Amgen, and Merck Sharp & Dohme, during the conduct of the study and personal fees from other companies outside the submitted work.

SOURCE: Cook G et al. Lancet Haematol. 2019 Mar;6(3):e154-66.

A proposed clinical scoring system using readily available laboratory data, rather than complex formulas, can be used to predict risk for overall survival and help with clinical decision making for patients with multiple myeloma who are ineligible for stem cell transplants, the system’s creators claim.

Peter Anderson/ Pathology Education Informational Resource Digital Library/copyright University of Alabama at Birmingham, Department of Pathology

When applied to data from two clinical trials that enrolled patients with transplant-ineligible multiple myeloma, the UK Myeloma Research Alliance Risk Profile (MRP) was shown to accurately group patients into low-, medium- and high-risk categories and was prognostic of overall survival, reported Gordon Cook, PhD, of the University of Leeds, England, and his colleagues.

“The ability of clinical scoring systems, such as that proposed here, to predict whether a patient is likely to stop treatment early because of treatment intolerability, could enable preemptive, upfront dose adjustments in patients with multiple myeloma, preventing toxicity and potentially enabling patients to stay on therapy for longer,” they wrote in the Lancet Haematology.

The investigators used data on 1,852 newly diagnosed patients recruited to the non–intensive treatment pathway of the UK’s National Cancer Research Institute Myeloma XI study (NCRI-XI, ISRCTN49407852) for a training dataset and internal validation dataset, and 520 patients recruited into the Medical Research Council Myeloma IX study (MRC-IX, ISRCTN68454111) for the test dataset.

Patient characteristics, biochemical measurements, and hematological data were plugged into univariate and multivariate models to determine their potential as prognostic variables.

The final model for the test and validation datasets included World Health Organization performance status, the multiple myeloma International Staging System, patient age, and C-reactive protein concentrations.

As noted before, the scoring algorithm groups patients into low-, medium- and high-risk categories, with each of the prognostic variables increasing in severity across the three groups in both clinical trials.

In the NCRI-XI trial, median overall survival for patients in the MRP low-risk group was 60 months, compared with 44 months in the medium-risk group, and 25 months in the high-risk group.

Similarly, in the MRC-IX trial, the respective median overall survival was 49, 34, and 20 months.

The risk groups also were associated with progression-free survival in each trial, although not as robustly as the association with overall survival.

The investigators also found that, the higher the risk group, the greater the likelihood that the median percentage of protocol dose delivered would be lower, and both a decrease in protocol dose delivered and quality of life at baseline were associated with increased risk.

The MRP categories were prognostic in patients treated with various therapeutic regimens and in patients with high-risk cytogenetics.

“None of the risk scoring systems previously developed in myeloma are dynamic, making them unable to accommodate changes in disease-related frailty that might be minimized by effective anti-myeloma therapy. There is therefore scope to improve clinical risk scores by the addition of a suitable frailty biomarker, which is currently still in developmental stages,” Dr. Cook and his colleagues wrote.

The study was funded by the Medical Research Council, Novartis, Schering Health Care, Chugai, Pharmion, Celgene, Ortho Biotech, Cancer Research UK, Celgene, Merck Sharp & Dohme, and Amgen. Dr. Cook reported grants and nonfinancial support from Celgene, Amgen, and Merck Sharp & Dohme, during the conduct of the study and personal fees from other companies outside the submitted work.

SOURCE: Cook G et al. Lancet Haematol. 2019 Mar;6(3):e154-66.

A proposed clinical scoring system using readily available laboratory data, rather than complex formulas, can be used to predict risk for overall survival and help with clinical decision making for patients with multiple myeloma who are ineligible for stem cell transplants, the system’s creators claim.

Peter Anderson/ Pathology Education Informational Resource Digital Library/copyright University of Alabama at Birmingham, Department of Pathology

When applied to data from two clinical trials that enrolled patients with transplant-ineligible multiple myeloma, the UK Myeloma Research Alliance Risk Profile (MRP) was shown to accurately group patients into low-, medium- and high-risk categories and was prognostic of overall survival, reported Gordon Cook, PhD, of the University of Leeds, England, and his colleagues.

“The ability of clinical scoring systems, such as that proposed here, to predict whether a patient is likely to stop treatment early because of treatment intolerability, could enable preemptive, upfront dose adjustments in patients with multiple myeloma, preventing toxicity and potentially enabling patients to stay on therapy for longer,” they wrote in the Lancet Haematology.

The investigators used data on 1,852 newly diagnosed patients recruited to the non–intensive treatment pathway of the UK’s National Cancer Research Institute Myeloma XI study (NCRI-XI, ISRCTN49407852) for a training dataset and internal validation dataset, and 520 patients recruited into the Medical Research Council Myeloma IX study (MRC-IX, ISRCTN68454111) for the test dataset.

Patient characteristics, biochemical measurements, and hematological data were plugged into univariate and multivariate models to determine their potential as prognostic variables.

The final model for the test and validation datasets included World Health Organization performance status, the multiple myeloma International Staging System, patient age, and C-reactive protein concentrations.

As noted before, the scoring algorithm groups patients into low-, medium- and high-risk categories, with each of the prognostic variables increasing in severity across the three groups in both clinical trials.

In the NCRI-XI trial, median overall survival for patients in the MRP low-risk group was 60 months, compared with 44 months in the medium-risk group, and 25 months in the high-risk group.

Similarly, in the MRC-IX trial, the respective median overall survival was 49, 34, and 20 months.

The risk groups also were associated with progression-free survival in each trial, although not as robustly as the association with overall survival.

The investigators also found that, the higher the risk group, the greater the likelihood that the median percentage of protocol dose delivered would be lower, and both a decrease in protocol dose delivered and quality of life at baseline were associated with increased risk.

The MRP categories were prognostic in patients treated with various therapeutic regimens and in patients with high-risk cytogenetics.

“None of the risk scoring systems previously developed in myeloma are dynamic, making them unable to accommodate changes in disease-related frailty that might be minimized by effective anti-myeloma therapy. There is therefore scope to improve clinical risk scores by the addition of a suitable frailty biomarker, which is currently still in developmental stages,” Dr. Cook and his colleagues wrote.

The study was funded by the Medical Research Council, Novartis, Schering Health Care, Chugai, Pharmion, Celgene, Ortho Biotech, Cancer Research UK, Celgene, Merck Sharp & Dohme, and Amgen. Dr. Cook reported grants and nonfinancial support from Celgene, Amgen, and Merck Sharp & Dohme, during the conduct of the study and personal fees from other companies outside the submitted work.

SOURCE: Cook G et al. Lancet Haematol. 2019 Mar;6(3):e154-66.

Children whose mothers experienced any type of infection during pregnancy were nearly 80 times more likely to be diagnosed with autism, compared with those whose mothers did not have infections. Also today, for FPs, 2018 was a big year for generating hospital revenue, prenatal betamethasone is not linked to later adverse neurocognitive problems, and heart-harming toxins may hurt hookah smokers.

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Children whose mothers experienced any type of infection during pregnancy were nearly 80 times more likely to be diagnosed with autism, compared with those whose mothers did not have infections. Also today, for FPs, 2018 was a big year for generating hospital revenue, prenatal betamethasone is not linked to later adverse neurocognitive problems, and heart-harming toxins may hurt hookah smokers.

Amazon Alexa

Apple Podcasts

Google Podcasts

Spotify
 

Children whose mothers experienced any type of infection during pregnancy were nearly 80 times more likely to be diagnosed with autism, compared with those whose mothers did not have infections. Also today, for FPs, 2018 was a big year for generating hospital revenue, prenatal betamethasone is not linked to later adverse neurocognitive problems, and heart-harming toxins may hurt hookah smokers.

Amazon Alexa

Apple Podcasts

Google Podcasts

Spotify
 

Black patients who undergo bariatric surgery have a higher rate of overall complications and a lower postsurgery quality of life than white patients, according to a study of bariatric surgery patients in Michigan.

“Per this analysis, there are significant racial disparities in perioperative outcomes, weight loss, and quality of life after bariatric surgery,” wrote lead author Michael H. Wood, MD, of Wayne State University, Detroit, and his coauthors, adding that, “while biological differences may explain some of the disparity in outcomes, environmental, social, and behavioral factors likely play a role.” The study was published online in JAMA Surgery.

This study reviewed data from 14,210 participants in the Michigan Bariatric Surgery Collaborative (MBSC), a state-wide consortium and clinical registry of bariatric surgery patients. Matching cohorts were established for black (n = 7,105) and white (n = 7,105) patients who underwent a primary bariatric operation (Roux-en-Y gastric bypass, sleeve gastrectomy, or adjustable gastric banding) between June 2006 and January 2017. The only significant differences between cohorts – clarified as “never more than 1 or 2 percentage points” – were in regard to income brackets and procedure type.

At 30-day follow-up, the rate of overall complications was higher in black patients (628, 8.8%) than in white patients (481, 6.8%; adjusted odds ratio, 1.33; 95% confidence interval, 1.17-1.51; P = .02), as was the length of stay (mean, 2.2 days vs. 1.9 days; aOR, 0.30; 95% CI, 0.20-0.40; P less than .001). Black patients also had a higher rate of both ED visits (541 [11.6%] vs. 826 [7.6%]; aOR, 1.60; 95% CI, 1.43-1.79; P less than .001) and readmissions (414 [5.8%] vs. 245 [3.5%]; aOR, 1.73; 95% CI, 1.47-2.03; P less than .001).

In addition, at 1-year follow-up, black patients had a lower mean weight loss (32.0 kg vs. 38.3 kg; P less than .001) and percentage of total weight loss (26% vs. 29%; P less than .001) compared with white patients. And though black patients were more likely than white patients to report a high quality of life before surgery (2,672 [49.5%] vs. 2,354 [41.4%]; P less than .001), they were less likely to do so 1 year afterward (1,379 [87.2%] vs. 2,133 [90.4%]; P = .002).

The coauthors acknowledged the limitations of their study, including potential unmeasured factors between cohorts such as disease duration or severity. They also noted that a wider time horizon than 30 days post surgery could have altered the results, although “serious adverse events and resource use tend to be highest within the first month after surgery, and we anticipate that this effect would have been negligible.”

The study was funded by Blue Cross Blue Shield Michigan/Blue Care Network. Dr. Wood reported no conflicts of interest. Three of his coauthors reported receiving salary support from Blue Cross Blue Shield Michigan/Blue Care Network for their work with the MBSC, and one other coauthor reported receiving an honorarium for being the MBSC’s executive committee chair.

The AGA Practice guide on Obesity and Weight management, Education and Resources (POWER) white paper provides physicians with a comprehensive, multi-disciplinary process to guide and personalize innovative obesity care for safe and effective weight management. Learn more at https://www.gastro.org/practice-guidance/practice-updates/obesity-practice-guide.

SOURCE: Wood MH et al. JAMA Surg. 2019 Mar 6. doi: 10.1001/jamasurg.2019.0029.

Black patients who undergo bariatric surgery have a higher rate of overall complications and a lower postsurgery quality of life than white patients, according to a study of bariatric surgery patients in Michigan.

“Per this analysis, there are significant racial disparities in perioperative outcomes, weight loss, and quality of life after bariatric surgery,” wrote lead author Michael H. Wood, MD, of Wayne State University, Detroit, and his coauthors, adding that, “while biological differences may explain some of the disparity in outcomes, environmental, social, and behavioral factors likely play a role.” The study was published online in JAMA Surgery.

This study reviewed data from 14,210 participants in the Michigan Bariatric Surgery Collaborative (MBSC), a state-wide consortium and clinical registry of bariatric surgery patients. Matching cohorts were established for black (n = 7,105) and white (n = 7,105) patients who underwent a primary bariatric operation (Roux-en-Y gastric bypass, sleeve gastrectomy, or adjustable gastric banding) between June 2006 and January 2017. The only significant differences between cohorts – clarified as “never more than 1 or 2 percentage points” – were in regard to income brackets and procedure type.

At 30-day follow-up, the rate of overall complications was higher in black patients (628, 8.8%) than in white patients (481, 6.8%; adjusted odds ratio, 1.33; 95% confidence interval, 1.17-1.51; P = .02), as was the length of stay (mean, 2.2 days vs. 1.9 days; aOR, 0.30; 95% CI, 0.20-0.40; P less than .001). Black patients also had a higher rate of both ED visits (541 [11.6%] vs. 826 [7.6%]; aOR, 1.60; 95% CI, 1.43-1.79; P less than .001) and readmissions (414 [5.8%] vs. 245 [3.5%]; aOR, 1.73; 95% CI, 1.47-2.03; P less than .001).

In addition, at 1-year follow-up, black patients had a lower mean weight loss (32.0 kg vs. 38.3 kg; P less than .001) and percentage of total weight loss (26% vs. 29%; P less than .001) compared with white patients. And though black patients were more likely than white patients to report a high quality of life before surgery (2,672 [49.5%] vs. 2,354 [41.4%]; P less than .001), they were less likely to do so 1 year afterward (1,379 [87.2%] vs. 2,133 [90.4%]; P = .002).

The coauthors acknowledged the limitations of their study, including potential unmeasured factors between cohorts such as disease duration or severity. They also noted that a wider time horizon than 30 days post surgery could have altered the results, although “serious adverse events and resource use tend to be highest within the first month after surgery, and we anticipate that this effect would have been negligible.”

The study was funded by Blue Cross Blue Shield Michigan/Blue Care Network. Dr. Wood reported no conflicts of interest. Three of his coauthors reported receiving salary support from Blue Cross Blue Shield Michigan/Blue Care Network for their work with the MBSC, and one other coauthor reported receiving an honorarium for being the MBSC’s executive committee chair.

The AGA Practice guide on Obesity and Weight management, Education and Resources (POWER) white paper provides physicians with a comprehensive, multi-disciplinary process to guide and personalize innovative obesity care for safe and effective weight management. Learn more at https://www.gastro.org/practice-guidance/practice-updates/obesity-practice-guide.

SOURCE: Wood MH et al. JAMA Surg. 2019 Mar 6. doi: 10.1001/jamasurg.2019.0029.

Black patients who undergo bariatric surgery have a higher rate of overall complications and a lower postsurgery quality of life than white patients, according to a study of bariatric surgery patients in Michigan.

“Per this analysis, there are significant racial disparities in perioperative outcomes, weight loss, and quality of life after bariatric surgery,” wrote lead author Michael H. Wood, MD, of Wayne State University, Detroit, and his coauthors, adding that, “while biological differences may explain some of the disparity in outcomes, environmental, social, and behavioral factors likely play a role.” The study was published online in JAMA Surgery.

This study reviewed data from 14,210 participants in the Michigan Bariatric Surgery Collaborative (MBSC), a state-wide consortium and clinical registry of bariatric surgery patients. Matching cohorts were established for black (n = 7,105) and white (n = 7,105) patients who underwent a primary bariatric operation (Roux-en-Y gastric bypass, sleeve gastrectomy, or adjustable gastric banding) between June 2006 and January 2017. The only significant differences between cohorts – clarified as “never more than 1 or 2 percentage points” – were in regard to income brackets and procedure type.

At 30-day follow-up, the rate of overall complications was higher in black patients (628, 8.8%) than in white patients (481, 6.8%; adjusted odds ratio, 1.33; 95% confidence interval, 1.17-1.51; P = .02), as was the length of stay (mean, 2.2 days vs. 1.9 days; aOR, 0.30; 95% CI, 0.20-0.40; P less than .001). Black patients also had a higher rate of both ED visits (541 [11.6%] vs. 826 [7.6%]; aOR, 1.60; 95% CI, 1.43-1.79; P less than .001) and readmissions (414 [5.8%] vs. 245 [3.5%]; aOR, 1.73; 95% CI, 1.47-2.03; P less than .001).

In addition, at 1-year follow-up, black patients had a lower mean weight loss (32.0 kg vs. 38.3 kg; P less than .001) and percentage of total weight loss (26% vs. 29%; P less than .001) compared with white patients. And though black patients were more likely than white patients to report a high quality of life before surgery (2,672 [49.5%] vs. 2,354 [41.4%]; P less than .001), they were less likely to do so 1 year afterward (1,379 [87.2%] vs. 2,133 [90.4%]; P = .002).

The coauthors acknowledged the limitations of their study, including potential unmeasured factors between cohorts such as disease duration or severity. They also noted that a wider time horizon than 30 days post surgery could have altered the results, although “serious adverse events and resource use tend to be highest within the first month after surgery, and we anticipate that this effect would have been negligible.”

The study was funded by Blue Cross Blue Shield Michigan/Blue Care Network. Dr. Wood reported no conflicts of interest. Three of his coauthors reported receiving salary support from Blue Cross Blue Shield Michigan/Blue Care Network for their work with the MBSC, and one other coauthor reported receiving an honorarium for being the MBSC’s executive committee chair.

The AGA Practice guide on Obesity and Weight management, Education and Resources (POWER) white paper provides physicians with a comprehensive, multi-disciplinary process to guide and personalize innovative obesity care for safe and effective weight management. Learn more at https://www.gastro.org/practice-guidance/practice-updates/obesity-practice-guide.

SOURCE: Wood MH et al. JAMA Surg. 2019 Mar 6. doi: 10.1001/jamasurg.2019.0029.

The Food and Drug Administration has approved dupilumab for adolescents with moderate to severe atopic dermatitis (AD) that has been inadequately controlled with topical prescription treatments “or when those therapies are not advisable.” 

Dupilumab (Dupixent), which inhibits interleukin-4 and interleukin-13 signaling, was initially approved in March 2017, for the same indication, becoming the first targeted biologic treatment for AD. The adolescent approval was announced by the manufacturer.

While there are several systemic medications used as second-line therapy for treatment of pediatric AD, dupilumab is the first FDA-approved biologic for treatment of the disease in adolescents aged 12-17 years, Dawn Marie R. Davis, MD, a pediatric dermatologist at the Mayo Clinic, Rochester (MN), and current president of the Society for Pediatric Dermatology, said in an interview.

FDA approval should decrease insurance barriers and the need for prior authorization, thus increasing access to the drug, she noted, adding, “I hope it will offer a successful alternative to other advanced therapies, as the medicine works through a different mechanism of action, compared to the current systemic medications available.”

With the expanded indication to include adolescents, “patients with more moderate to severe disease who aren’t well controlled with a topical therapy are going to get treatment that will change their lives for many years to come,” dupilumab investigator Eric L. Simpson, MD, professor of dermatology at Oregon Health & Science University, Portland, said in an interview. “On the whole, patients are likely being undertreated and suffering from the disease more than they need to be,” said Dr. Simpson, “With the advent of this new therapy and the new data, it’s going to change the risk benefit calculation for providers and for patients.”

Results from a phase 3 clinical trial of dupilumab in adolescents with moderate to severe AD were presented last fall at the European Academy of Dermatology and Venereology Congress in Paris. In that study, the proportion of patients who achieved a 75% or greater improvement in the Eczema Area and Severity Index at 16 weeks was 38.1% with monthly dupilumab, 41.5% with dupilumab every 2 weeks, and 8.2% with placebo. Dr. Simpson, the first author of this study, presented the results at that meeting.

Dr. Simpson said that he hopes dupilumab approval for adolescents and the clinical trial results will help providers recognize when patients are not in good control of their AD, and which patients qualify for a step-up in therapy when treatments such as topical therapy or prednisone are not effective. “There are so many patients out there who qualify for a step-up in therapy,” he commented. “I hope that provides comfort to both patients and providers, that it’s OK to take the next step, because the results show us that, not only it can improve your skin rash, but it can have dramatic effects on all the downstream effects of the condition.”

These downstream effects include not only quality of life and comorbidities of mental health but also the patient’s emotional state. Hopefully, dupilumab can reduce stigmatization of AD and feelings of embarrassment for adolescents at a time in life when “socialization, education, and activity is so important in creating your kind of identity in yourself and your sense of self-worth,” Dr. Simpson said.

“It is important to remember atopic dermatitis is a disease that impacts not only the skin, but the patient as a whole,” said Dr. Davis. “It is an exciting time to be caring for atopic dermatitis patients with the various new medications coming to market.”

The FDA had granted a priority review for the adolescent indication; previously the FDA had granted Breakthrough Therapy designation for dupilumab in 2016 for the treatment of moderate to severe AD in adolescents and severe AD in children aged 6 months to 11 years who are insufficiently controlled with topical medications

The dosing for adolescents is weight based; two doses are available, 200 mg and 300 mg, administered subcutaneously, every other week after a loading dose. The updated prescribing information is available at https://www.regeneron.com/sites/default/files/Dupixent_FPI.pdf.Dr. Simpson reports relationships with Sanofi and Regeneron Pharmaceuticals. Dr. Davis reports no relevant financial disclosures.

The Food and Drug Administration has approved dupilumab for adolescents with moderate to severe atopic dermatitis (AD) that has been inadequately controlled with topical prescription treatments “or when those therapies are not advisable.” 

Dupilumab (Dupixent), which inhibits interleukin-4 and interleukin-13 signaling, was initially approved in March 2017, for the same indication, becoming the first targeted biologic treatment for AD. The adolescent approval was announced by the manufacturer.

While there are several systemic medications used as second-line therapy for treatment of pediatric AD, dupilumab is the first FDA-approved biologic for treatment of the disease in adolescents aged 12-17 years, Dawn Marie R. Davis, MD, a pediatric dermatologist at the Mayo Clinic, Rochester (MN), and current president of the Society for Pediatric Dermatology, said in an interview.

FDA approval should decrease insurance barriers and the need for prior authorization, thus increasing access to the drug, she noted, adding, “I hope it will offer a successful alternative to other advanced therapies, as the medicine works through a different mechanism of action, compared to the current systemic medications available.”

With the expanded indication to include adolescents, “patients with more moderate to severe disease who aren’t well controlled with a topical therapy are going to get treatment that will change their lives for many years to come,” dupilumab investigator Eric L. Simpson, MD, professor of dermatology at Oregon Health & Science University, Portland, said in an interview. “On the whole, patients are likely being undertreated and suffering from the disease more than they need to be,” said Dr. Simpson, “With the advent of this new therapy and the new data, it’s going to change the risk benefit calculation for providers and for patients.”

Results from a phase 3 clinical trial of dupilumab in adolescents with moderate to severe AD were presented last fall at the European Academy of Dermatology and Venereology Congress in Paris. In that study, the proportion of patients who achieved a 75% or greater improvement in the Eczema Area and Severity Index at 16 weeks was 38.1% with monthly dupilumab, 41.5% with dupilumab every 2 weeks, and 8.2% with placebo. Dr. Simpson, the first author of this study, presented the results at that meeting.

Dr. Simpson said that he hopes dupilumab approval for adolescents and the clinical trial results will help providers recognize when patients are not in good control of their AD, and which patients qualify for a step-up in therapy when treatments such as topical therapy or prednisone are not effective. “There are so many patients out there who qualify for a step-up in therapy,” he commented. “I hope that provides comfort to both patients and providers, that it’s OK to take the next step, because the results show us that, not only it can improve your skin rash, but it can have dramatic effects on all the downstream effects of the condition.”

These downstream effects include not only quality of life and comorbidities of mental health but also the patient’s emotional state. Hopefully, dupilumab can reduce stigmatization of AD and feelings of embarrassment for adolescents at a time in life when “socialization, education, and activity is so important in creating your kind of identity in yourself and your sense of self-worth,” Dr. Simpson said.

“It is important to remember atopic dermatitis is a disease that impacts not only the skin, but the patient as a whole,” said Dr. Davis. “It is an exciting time to be caring for atopic dermatitis patients with the various new medications coming to market.”

The FDA had granted a priority review for the adolescent indication; previously the FDA had granted Breakthrough Therapy designation for dupilumab in 2016 for the treatment of moderate to severe AD in adolescents and severe AD in children aged 6 months to 11 years who are insufficiently controlled with topical medications

The dosing for adolescents is weight based; two doses are available, 200 mg and 300 mg, administered subcutaneously, every other week after a loading dose. The updated prescribing information is available at https://www.regeneron.com/sites/default/files/Dupixent_FPI.pdf.Dr. Simpson reports relationships with Sanofi and Regeneron Pharmaceuticals. Dr. Davis reports no relevant financial disclosures.

The Food and Drug Administration has approved dupilumab for adolescents with moderate to severe atopic dermatitis (AD) that has been inadequately controlled with topical prescription treatments “or when those therapies are not advisable.” 

Dupilumab (Dupixent), which inhibits interleukin-4 and interleukin-13 signaling, was initially approved in March 2017, for the same indication, becoming the first targeted biologic treatment for AD. The adolescent approval was announced by the manufacturer.

While there are several systemic medications used as second-line therapy for treatment of pediatric AD, dupilumab is the first FDA-approved biologic for treatment of the disease in adolescents aged 12-17 years, Dawn Marie R. Davis, MD, a pediatric dermatologist at the Mayo Clinic, Rochester (MN), and current president of the Society for Pediatric Dermatology, said in an interview.

FDA approval should decrease insurance barriers and the need for prior authorization, thus increasing access to the drug, she noted, adding, “I hope it will offer a successful alternative to other advanced therapies, as the medicine works through a different mechanism of action, compared to the current systemic medications available.”

With the expanded indication to include adolescents, “patients with more moderate to severe disease who aren’t well controlled with a topical therapy are going to get treatment that will change their lives for many years to come,” dupilumab investigator Eric L. Simpson, MD, professor of dermatology at Oregon Health & Science University, Portland, said in an interview. “On the whole, patients are likely being undertreated and suffering from the disease more than they need to be,” said Dr. Simpson, “With the advent of this new therapy and the new data, it’s going to change the risk benefit calculation for providers and for patients.”

Results from a phase 3 clinical trial of dupilumab in adolescents with moderate to severe AD were presented last fall at the European Academy of Dermatology and Venereology Congress in Paris. In that study, the proportion of patients who achieved a 75% or greater improvement in the Eczema Area and Severity Index at 16 weeks was 38.1% with monthly dupilumab, 41.5% with dupilumab every 2 weeks, and 8.2% with placebo. Dr. Simpson, the first author of this study, presented the results at that meeting.

Dr. Simpson said that he hopes dupilumab approval for adolescents and the clinical trial results will help providers recognize when patients are not in good control of their AD, and which patients qualify for a step-up in therapy when treatments such as topical therapy or prednisone are not effective. “There are so many patients out there who qualify for a step-up in therapy,” he commented. “I hope that provides comfort to both patients and providers, that it’s OK to take the next step, because the results show us that, not only it can improve your skin rash, but it can have dramatic effects on all the downstream effects of the condition.”

These downstream effects include not only quality of life and comorbidities of mental health but also the patient’s emotional state. Hopefully, dupilumab can reduce stigmatization of AD and feelings of embarrassment for adolescents at a time in life when “socialization, education, and activity is so important in creating your kind of identity in yourself and your sense of self-worth,” Dr. Simpson said.

“It is important to remember atopic dermatitis is a disease that impacts not only the skin, but the patient as a whole,” said Dr. Davis. “It is an exciting time to be caring for atopic dermatitis patients with the various new medications coming to market.”

The FDA had granted a priority review for the adolescent indication; previously the FDA had granted Breakthrough Therapy designation for dupilumab in 2016 for the treatment of moderate to severe AD in adolescents and severe AD in children aged 6 months to 11 years who are insufficiently controlled with topical medications

The dosing for adolescents is weight based; two doses are available, 200 mg and 300 mg, administered subcutaneously, every other week after a loading dose. The updated prescribing information is available at https://www.regeneron.com/sites/default/files/Dupixent_FPI.pdf.Dr. Simpson reports relationships with Sanofi and Regeneron Pharmaceuticals. Dr. Davis reports no relevant financial disclosures.

The number of new measles cases was down by more than half last week, but another state has been added to the list of those with reported cases in 2019, according to the Centers for Disease Control and Prevention.

There were 21 new measles cases reported to the CDC during the week ending March 7 – down from 47 the week before. The total for the year is 228 cases, which moves 2019 ahead of 2011 for third place over the last decade, the CDC reported March 11. Going back even further in time, the 206 measles cases reported through January and February is the highest 2-month total in a quarter of a century, the Washington Post said.

New Hampshire became the 12th and latest state to report a case of measles this year, joining California, Colorado, Connecticut, Georgia, Illinois, Kentucky, New Jersey, New York, Oregon, Texas, and Washington. California’s situation is now considered an outbreak (defined as three or more cases), but one of the three outbreaks in New York has been taken off the list, so total outbreaks for 2019 remain at six, the CDC said.

For the third consecutive week, New York City produced the most measles cases, with Brooklyn’s Williamsburg neighborhood recording 11 of the U.S. total of 21. The outbreak in King County, Wash., – totaling 70 cases this year – may be winding down as only one new case was reported last week, and no new cases are being investigated, the county’s public health service reported.

[email protected]

The number of new measles cases was down by more than half last week, but another state has been added to the list of those with reported cases in 2019, according to the Centers for Disease Control and Prevention.

There were 21 new measles cases reported to the CDC during the week ending March 7 – down from 47 the week before. The total for the year is 228 cases, which moves 2019 ahead of 2011 for third place over the last decade, the CDC reported March 11. Going back even further in time, the 206 measles cases reported through January and February is the highest 2-month total in a quarter of a century, the Washington Post said.

New Hampshire became the 12th and latest state to report a case of measles this year, joining California, Colorado, Connecticut, Georgia, Illinois, Kentucky, New Jersey, New York, Oregon, Texas, and Washington. California’s situation is now considered an outbreak (defined as three or more cases), but one of the three outbreaks in New York has been taken off the list, so total outbreaks for 2019 remain at six, the CDC said.

For the third consecutive week, New York City produced the most measles cases, with Brooklyn’s Williamsburg neighborhood recording 11 of the U.S. total of 21. The outbreak in King County, Wash., – totaling 70 cases this year – may be winding down as only one new case was reported last week, and no new cases are being investigated, the county’s public health service reported.

[email protected]

The number of new measles cases was down by more than half last week, but another state has been added to the list of those with reported cases in 2019, according to the Centers for Disease Control and Prevention.

There were 21 new measles cases reported to the CDC during the week ending March 7 – down from 47 the week before. The total for the year is 228 cases, which moves 2019 ahead of 2011 for third place over the last decade, the CDC reported March 11. Going back even further in time, the 206 measles cases reported through January and February is the highest 2-month total in a quarter of a century, the Washington Post said.

New Hampshire became the 12th and latest state to report a case of measles this year, joining California, Colorado, Connecticut, Georgia, Illinois, Kentucky, New Jersey, New York, Oregon, Texas, and Washington. California’s situation is now considered an outbreak (defined as three or more cases), but one of the three outbreaks in New York has been taken off the list, so total outbreaks for 2019 remain at six, the CDC said.

For the third consecutive week, New York City produced the most measles cases, with Brooklyn’s Williamsburg neighborhood recording 11 of the U.S. total of 21. The outbreak in King County, Wash., – totaling 70 cases this year – may be winding down as only one new case was reported last week, and no new cases are being investigated, the county’s public health service reported.

[email protected]

SAN FRANCISCO – A combination of a targeted therapy and an immune checkpoint inhibitor showed promising activity against advanced urothelial cancer in early data from a phase 1b/2 study.

In a cohort of 20 patients with urothelial carcinoma who were enrolled in a larger clinical trial testing the combination of the tyrosine kinase inhibitor (TKI) lenvatinib (Lenvima) and the checkpoint inhibitor pembrolizumab (Keytruda) against urinary tract and other solid malignancies, 5 had an objective response to the combination, including one complete and four partial responses, for an objective response rate of 25%, reported Nicholas J. Vogelzang, MD, from Comprehensive Cancers Centers of Nevada in Las Vegas.

“This response rate warrants further investigation. The lenvatinib plus pembrolizumab combination will be studied in a phase 3 trial in urothelial carcinoma,” he said at the American Society of Clinical Oncology (ASCO) - Society for Immunotherapy of Cancer (SITC): Clinical Immuno-Oncology Symposium.

Dr. Vogelzang noted that urothelial carcinomas account for more than 90% of all bladder cancers. Pembrolizumab monotherapy is approved for treatment of patients with urothelial carcinoma who are ineligible for cisplatin and whose tumors have a combined positive score (CPS) for programmed death-ligand 1 (PD-L1) of 10 or greater or who are ineligible for platinum-based chemotherapy regimens and, in the second line, for advanced or metastatic urothelial carcinoma.

Lenvatinib, a multikinase inhibitor, is approved as monotherapy for radioiodine-refractory differentiated thyroid cancer, unresectable hepatocellular carcinoma, and in combination with everolimus for advanced renal cell carcinoma (RCC) after one year of antiangiogenic therapy.

Dr. Vogelzang reported results of the urothelial cancer cohort from a multicohort study testing the combination.

Twenty patients with histologically confirmed metastatic urothelial cancer were enrolled. The patients all had no more than two prior systemic regimens, good performance status, and a life expectancy of at least 12 weeks. The patients received oral lenvatinib 20 mg daily and pembrolizumab 200 mg intravenously every 21 days. The median patient age was 72 years. The cohort included 14 men and six women.

The objective response rate (ORR) at 24 weeks, the primary endpoint, was 25%, comprising one complete and four partial responses. Nine patients had stable disease, two had disease progression, and four were not evaluable for efficacy. The results were identical according to immune-related Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 and modified RECIST version 1.1. Of the 16 evaluable patients, 12 experienced tumor-size reductions from baseline.

“Although there were five objective responses, there were an additional seven patients or more who had minor regressions of disease – clearly an active regimen,” Dr. Vogelzang said. Four of the patients, including one with a PD-L1–positive tumor and three with PD-L1–negative tumors were still alive, with the longest survival past 80 weeks since the start of therapy. The majority of patients, however, had no objective response or disease progression within about 20 weeks.

After a median follow-up of 11.7 months, the median progression-free survival (PFS) was 5.4 months, and the 12-month PFS rate was 26%.

In all, 18 of the 20 patients (90%) experienced a treatment-related adverse event of any grade, 10 had grade 3 or 4 events, and 6 had serious adverse events including one death from gastrointestinal hemorrhage that Dr. Vogelzang said appeared to be related to lenvatinib. A total of four patients (20%) had a treatment-related event leading to withdrawal or discontinuation, seven had a dose reduction, and 12 had an interruption in therapy, primarily of lenvatinib. The most common toxicities were proteinuria, diarrhea, hypertension, fatigue, hypothyroidism, decreased appetite with nausea, pancreatitis with increased lipase, skin rash, vomiting, and dry mouth.

In addition to the planned phase 3 trial of the combination in urothelial carcinoma, lenvatinib/pembrolizumab is also being studied for the treatment of RCC.

The study was supported by Eisai and Merck Sharp & Dohme. Dr. Vogelzang disclosed financial relationships with Caris Life Sciences, Pfizer, Up to Date, AstraZeneca, MedImmune, and other companies. Five coauthors are employees of Merck or Esai.

SOURCE: Vogelzang NJ et al. ASCO-SITC, Abstract 11.

SAN FRANCISCO – A combination of a targeted therapy and an immune checkpoint inhibitor showed promising activity against advanced urothelial cancer in early data from a phase 1b/2 study.

In a cohort of 20 patients with urothelial carcinoma who were enrolled in a larger clinical trial testing the combination of the tyrosine kinase inhibitor (TKI) lenvatinib (Lenvima) and the checkpoint inhibitor pembrolizumab (Keytruda) against urinary tract and other solid malignancies, 5 had an objective response to the combination, including one complete and four partial responses, for an objective response rate of 25%, reported Nicholas J. Vogelzang, MD, from Comprehensive Cancers Centers of Nevada in Las Vegas.

“This response rate warrants further investigation. The lenvatinib plus pembrolizumab combination will be studied in a phase 3 trial in urothelial carcinoma,” he said at the American Society of Clinical Oncology (ASCO) - Society for Immunotherapy of Cancer (SITC): Clinical Immuno-Oncology Symposium.

Dr. Vogelzang noted that urothelial carcinomas account for more than 90% of all bladder cancers. Pembrolizumab monotherapy is approved for treatment of patients with urothelial carcinoma who are ineligible for cisplatin and whose tumors have a combined positive score (CPS) for programmed death-ligand 1 (PD-L1) of 10 or greater or who are ineligible for platinum-based chemotherapy regimens and, in the second line, for advanced or metastatic urothelial carcinoma.

Lenvatinib, a multikinase inhibitor, is approved as monotherapy for radioiodine-refractory differentiated thyroid cancer, unresectable hepatocellular carcinoma, and in combination with everolimus for advanced renal cell carcinoma (RCC) after one year of antiangiogenic therapy.

Dr. Vogelzang reported results of the urothelial cancer cohort from a multicohort study testing the combination.

Twenty patients with histologically confirmed metastatic urothelial cancer were enrolled. The patients all had no more than two prior systemic regimens, good performance status, and a life expectancy of at least 12 weeks. The patients received oral lenvatinib 20 mg daily and pembrolizumab 200 mg intravenously every 21 days. The median patient age was 72 years. The cohort included 14 men and six women.

The objective response rate (ORR) at 24 weeks, the primary endpoint, was 25%, comprising one complete and four partial responses. Nine patients had stable disease, two had disease progression, and four were not evaluable for efficacy. The results were identical according to immune-related Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 and modified RECIST version 1.1. Of the 16 evaluable patients, 12 experienced tumor-size reductions from baseline.

“Although there were five objective responses, there were an additional seven patients or more who had minor regressions of disease – clearly an active regimen,” Dr. Vogelzang said. Four of the patients, including one with a PD-L1–positive tumor and three with PD-L1–negative tumors were still alive, with the longest survival past 80 weeks since the start of therapy. The majority of patients, however, had no objective response or disease progression within about 20 weeks.

After a median follow-up of 11.7 months, the median progression-free survival (PFS) was 5.4 months, and the 12-month PFS rate was 26%.

In all, 18 of the 20 patients (90%) experienced a treatment-related adverse event of any grade, 10 had grade 3 or 4 events, and 6 had serious adverse events including one death from gastrointestinal hemorrhage that Dr. Vogelzang said appeared to be related to lenvatinib. A total of four patients (20%) had a treatment-related event leading to withdrawal or discontinuation, seven had a dose reduction, and 12 had an interruption in therapy, primarily of lenvatinib. The most common toxicities were proteinuria, diarrhea, hypertension, fatigue, hypothyroidism, decreased appetite with nausea, pancreatitis with increased lipase, skin rash, vomiting, and dry mouth.

In addition to the planned phase 3 trial of the combination in urothelial carcinoma, lenvatinib/pembrolizumab is also being studied for the treatment of RCC.

The study was supported by Eisai and Merck Sharp & Dohme. Dr. Vogelzang disclosed financial relationships with Caris Life Sciences, Pfizer, Up to Date, AstraZeneca, MedImmune, and other companies. Five coauthors are employees of Merck or Esai.

SOURCE: Vogelzang NJ et al. ASCO-SITC, Abstract 11.

SAN FRANCISCO – A combination of a targeted therapy and an immune checkpoint inhibitor showed promising activity against advanced urothelial cancer in early data from a phase 1b/2 study.

In a cohort of 20 patients with urothelial carcinoma who were enrolled in a larger clinical trial testing the combination of the tyrosine kinase inhibitor (TKI) lenvatinib (Lenvima) and the checkpoint inhibitor pembrolizumab (Keytruda) against urinary tract and other solid malignancies, 5 had an objective response to the combination, including one complete and four partial responses, for an objective response rate of 25%, reported Nicholas J. Vogelzang, MD, from Comprehensive Cancers Centers of Nevada in Las Vegas.

“This response rate warrants further investigation. The lenvatinib plus pembrolizumab combination will be studied in a phase 3 trial in urothelial carcinoma,” he said at the American Society of Clinical Oncology (ASCO) - Society for Immunotherapy of Cancer (SITC): Clinical Immuno-Oncology Symposium.

Dr. Vogelzang noted that urothelial carcinomas account for more than 90% of all bladder cancers. Pembrolizumab monotherapy is approved for treatment of patients with urothelial carcinoma who are ineligible for cisplatin and whose tumors have a combined positive score (CPS) for programmed death-ligand 1 (PD-L1) of 10 or greater or who are ineligible for platinum-based chemotherapy regimens and, in the second line, for advanced or metastatic urothelial carcinoma.

Lenvatinib, a multikinase inhibitor, is approved as monotherapy for radioiodine-refractory differentiated thyroid cancer, unresectable hepatocellular carcinoma, and in combination with everolimus for advanced renal cell carcinoma (RCC) after one year of antiangiogenic therapy.

Dr. Vogelzang reported results of the urothelial cancer cohort from a multicohort study testing the combination.

Twenty patients with histologically confirmed metastatic urothelial cancer were enrolled. The patients all had no more than two prior systemic regimens, good performance status, and a life expectancy of at least 12 weeks. The patients received oral lenvatinib 20 mg daily and pembrolizumab 200 mg intravenously every 21 days. The median patient age was 72 years. The cohort included 14 men and six women.

The objective response rate (ORR) at 24 weeks, the primary endpoint, was 25%, comprising one complete and four partial responses. Nine patients had stable disease, two had disease progression, and four were not evaluable for efficacy. The results were identical according to immune-related Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 and modified RECIST version 1.1. Of the 16 evaluable patients, 12 experienced tumor-size reductions from baseline.

“Although there were five objective responses, there were an additional seven patients or more who had minor regressions of disease – clearly an active regimen,” Dr. Vogelzang said. Four of the patients, including one with a PD-L1–positive tumor and three with PD-L1–negative tumors were still alive, with the longest survival past 80 weeks since the start of therapy. The majority of patients, however, had no objective response or disease progression within about 20 weeks.

After a median follow-up of 11.7 months, the median progression-free survival (PFS) was 5.4 months, and the 12-month PFS rate was 26%.

In all, 18 of the 20 patients (90%) experienced a treatment-related adverse event of any grade, 10 had grade 3 or 4 events, and 6 had serious adverse events including one death from gastrointestinal hemorrhage that Dr. Vogelzang said appeared to be related to lenvatinib. A total of four patients (20%) had a treatment-related event leading to withdrawal or discontinuation, seven had a dose reduction, and 12 had an interruption in therapy, primarily of lenvatinib. The most common toxicities were proteinuria, diarrhea, hypertension, fatigue, hypothyroidism, decreased appetite with nausea, pancreatitis with increased lipase, skin rash, vomiting, and dry mouth.

In addition to the planned phase 3 trial of the combination in urothelial carcinoma, lenvatinib/pembrolizumab is also being studied for the treatment of RCC.

The study was supported by Eisai and Merck Sharp & Dohme. Dr. Vogelzang disclosed financial relationships with Caris Life Sciences, Pfizer, Up to Date, AstraZeneca, MedImmune, and other companies. Five coauthors are employees of Merck or Esai.

SOURCE: Vogelzang NJ et al. ASCO-SITC, Abstract 11.

Young-onset colorectal cancer (CRC) has distinct clinical and molecular features, compared with disease diagnosed later in life, according to investigators who conducted a review that included more than 36,000 patients.

KUO CHUN HUNG/Thinkstock

CRC patients younger than 50 years of age were more likely to have distal primary tumors, synchronous metastatic disease, and microsatellite instability (MSI) than were older patients, investigators said. Conversely, those younger patients were less likely to have BRAF V600 mutations than were patients 50 years old and older, the investigators reported in the journal Cancer.

Very young patients were more likely to have signet ring histology and less likely to have adenomatous polyposis coli (APC) mutations, according to senior study author Jonathan M. Loree, MD, and his coinvestigators at The University of Texas MD Anderson Cancer Center, Houston.

“We need to appreciate that there are unique biologic subtypes within young patients that may affect how their cancers behave and may require a personalized approach to treatment,” Dr. Loree said in a press statement. “Going forward, special clinical consideration should be given to, and further scientific investigations should be performed for, both very young patients with colorectal cancer and those with predisposing medical conditions.”

The incidence of young-onset CRC has increased 1%-3% annually in recent years, Dr. Loree and colleagues wrote in their report.

Although smaller studies have characterized molecular features of CRC in younger patients, there has so far been no comprehensive molecular characterization of these patients, they added. Accordingly, the investigators conducted a retrospective analysis that included more than 36,000 patients in four different patient cohorts.

Patients under 50 years more likely had synchronous metastases (P = .009), more likely had primary tumors in the distal colon and rectum (P less than .0001), and were more likely to be MSI-high (P = .038), compared with their older counterparts, Dr. Loree and coauthors reported.

BRAF V600 mutations were infrequent in patients under 30 years of age, at a prevalence of 4% or less, increasing to a high of 13% in patients aged 70 years or older (P less than 0.001), investigators also reported.

Very young patients, or those aged 18-29 years, had a higher prevalence of signet ring histology, compared with the other age groups (P = .0003), and they had a nearly fivefold increased odds of signet ring histology compared with patients in the 30-49 year age range, investigators wrote.

There were also considerably fewer APC mutations in the patients younger than 30 years, compared with older patients in the young-onset CRC group, with an odds ratio of 0.56 (95% confidence interval, 0.35-0.90; P = .015).

Hispanic patients were significantly overrepresented in the under-30-years age group (P = .0015), according to the report.

For patients under 50 years who also had inflammatory bowel disease, odds of mucinous or signet ring histology were higher (OR, 5.54; 95% CI, 2.24-13.74; P = .0004), and odds of APC mutations were lower (OR, 0.24; 95% CI, 0.07-0.75; P = .019), compared with younger patients with no such predisposing conditions.

“These notable differences in very young patients with CRC and those with predisposing conditions highlight that early-onset CRC has unique subsets within the population of patients younger than 50 years,” Dr. Loree and coauthors concluded.

Support to investigators in the study came from the National Cancer Institute, National Institutes of Health, and the MD Anderson Colorectal Cancer Moon Shot Program. One coinvestigator reported disclosures related to Roche, Genentech, EMD Serono, Merck, Karyopharm, Amal, Navire, Symphogen, Holystone, Biocartis, Amgen, and Novartis.
 

SOURCE: Willauer AN et al. Cancer. 2019 Mar 11. doi: 10.1002/cncr.31994

Young-onset colorectal cancer (CRC) has distinct clinical and molecular features, compared with disease diagnosed later in life, according to investigators who conducted a review that included more than 36,000 patients.

KUO CHUN HUNG/Thinkstock

CRC patients younger than 50 years of age were more likely to have distal primary tumors, synchronous metastatic disease, and microsatellite instability (MSI) than were older patients, investigators said. Conversely, those younger patients were less likely to have BRAF V600 mutations than were patients 50 years old and older, the investigators reported in the journal Cancer.

Very young patients were more likely to have signet ring histology and less likely to have adenomatous polyposis coli (APC) mutations, according to senior study author Jonathan M. Loree, MD, and his coinvestigators at The University of Texas MD Anderson Cancer Center, Houston.

“We need to appreciate that there are unique biologic subtypes within young patients that may affect how their cancers behave and may require a personalized approach to treatment,” Dr. Loree said in a press statement. “Going forward, special clinical consideration should be given to, and further scientific investigations should be performed for, both very young patients with colorectal cancer and those with predisposing medical conditions.”

The incidence of young-onset CRC has increased 1%-3% annually in recent years, Dr. Loree and colleagues wrote in their report.

Although smaller studies have characterized molecular features of CRC in younger patients, there has so far been no comprehensive molecular characterization of these patients, they added. Accordingly, the investigators conducted a retrospective analysis that included more than 36,000 patients in four different patient cohorts.

Patients under 50 years more likely had synchronous metastases (P = .009), more likely had primary tumors in the distal colon and rectum (P less than .0001), and were more likely to be MSI-high (P = .038), compared with their older counterparts, Dr. Loree and coauthors reported.

BRAF V600 mutations were infrequent in patients under 30 years of age, at a prevalence of 4% or less, increasing to a high of 13% in patients aged 70 years or older (P less than 0.001), investigators also reported.

Very young patients, or those aged 18-29 years, had a higher prevalence of signet ring histology, compared with the other age groups (P = .0003), and they had a nearly fivefold increased odds of signet ring histology compared with patients in the 30-49 year age range, investigators wrote.

There were also considerably fewer APC mutations in the patients younger than 30 years, compared with older patients in the young-onset CRC group, with an odds ratio of 0.56 (95% confidence interval, 0.35-0.90; P = .015).

Hispanic patients were significantly overrepresented in the under-30-years age group (P = .0015), according to the report.

For patients under 50 years who also had inflammatory bowel disease, odds of mucinous or signet ring histology were higher (OR, 5.54; 95% CI, 2.24-13.74; P = .0004), and odds of APC mutations were lower (OR, 0.24; 95% CI, 0.07-0.75; P = .019), compared with younger patients with no such predisposing conditions.

“These notable differences in very young patients with CRC and those with predisposing conditions highlight that early-onset CRC has unique subsets within the population of patients younger than 50 years,” Dr. Loree and coauthors concluded.

Support to investigators in the study came from the National Cancer Institute, National Institutes of Health, and the MD Anderson Colorectal Cancer Moon Shot Program. One coinvestigator reported disclosures related to Roche, Genentech, EMD Serono, Merck, Karyopharm, Amal, Navire, Symphogen, Holystone, Biocartis, Amgen, and Novartis.
 

SOURCE: Willauer AN et al. Cancer. 2019 Mar 11. doi: 10.1002/cncr.31994

Young-onset colorectal cancer (CRC) has distinct clinical and molecular features, compared with disease diagnosed later in life, according to investigators who conducted a review that included more than 36,000 patients.

KUO CHUN HUNG/Thinkstock

CRC patients younger than 50 years of age were more likely to have distal primary tumors, synchronous metastatic disease, and microsatellite instability (MSI) than were older patients, investigators said. Conversely, those younger patients were less likely to have BRAF V600 mutations than were patients 50 years old and older, the investigators reported in the journal Cancer.

Very young patients were more likely to have signet ring histology and less likely to have adenomatous polyposis coli (APC) mutations, according to senior study author Jonathan M. Loree, MD, and his coinvestigators at The University of Texas MD Anderson Cancer Center, Houston.

“We need to appreciate that there are unique biologic subtypes within young patients that may affect how their cancers behave and may require a personalized approach to treatment,” Dr. Loree said in a press statement. “Going forward, special clinical consideration should be given to, and further scientific investigations should be performed for, both very young patients with colorectal cancer and those with predisposing medical conditions.”

The incidence of young-onset CRC has increased 1%-3% annually in recent years, Dr. Loree and colleagues wrote in their report.

Although smaller studies have characterized molecular features of CRC in younger patients, there has so far been no comprehensive molecular characterization of these patients, they added. Accordingly, the investigators conducted a retrospective analysis that included more than 36,000 patients in four different patient cohorts.

Patients under 50 years more likely had synchronous metastases (P = .009), more likely had primary tumors in the distal colon and rectum (P less than .0001), and were more likely to be MSI-high (P = .038), compared with their older counterparts, Dr. Loree and coauthors reported.

BRAF V600 mutations were infrequent in patients under 30 years of age, at a prevalence of 4% or less, increasing to a high of 13% in patients aged 70 years or older (P less than 0.001), investigators also reported.

Very young patients, or those aged 18-29 years, had a higher prevalence of signet ring histology, compared with the other age groups (P = .0003), and they had a nearly fivefold increased odds of signet ring histology compared with patients in the 30-49 year age range, investigators wrote.

There were also considerably fewer APC mutations in the patients younger than 30 years, compared with older patients in the young-onset CRC group, with an odds ratio of 0.56 (95% confidence interval, 0.35-0.90; P = .015).

Hispanic patients were significantly overrepresented in the under-30-years age group (P = .0015), according to the report.

For patients under 50 years who also had inflammatory bowel disease, odds of mucinous or signet ring histology were higher (OR, 5.54; 95% CI, 2.24-13.74; P = .0004), and odds of APC mutations were lower (OR, 0.24; 95% CI, 0.07-0.75; P = .019), compared with younger patients with no such predisposing conditions.

“These notable differences in very young patients with CRC and those with predisposing conditions highlight that early-onset CRC has unique subsets within the population of patients younger than 50 years,” Dr. Loree and coauthors concluded.

Support to investigators in the study came from the National Cancer Institute, National Institutes of Health, and the MD Anderson Colorectal Cancer Moon Shot Program. One coinvestigator reported disclosures related to Roche, Genentech, EMD Serono, Merck, Karyopharm, Amal, Navire, Symphogen, Holystone, Biocartis, Amgen, and Novartis.
 

SOURCE: Willauer AN et al. Cancer. 2019 Mar 11. doi: 10.1002/cncr.31994

Administering antenatal corticosteroids to pregnant women at high risk for preterm birth was a cost-effective intervention that improved infant respiratory outcomes, according to a new study.

“This intervention has a potential cost saving in the United States of approximately $100 million dollars annually from the benefit in the immediate neonatal outcome alone,” Cynthia Gyamfi-Bannerman, MD, of Columbia University, New York, and her associates reported in JAMA Pediatrics. “Because late preterm birth comprises a large proportion of all preterm births, our findings have the potential for a large influence on public health.”

The researchers conducted a retrospective secondary analysis of the randomized Antenatal Late Preterm Steroids (ALPS) clinical trial October 2010 to February 2015. The trial enrolled randomly assigned antenatal administration of betamethasone or placebo to women pregnant with a singleton and at high risk for preterm birth while between 34 weeks, 6 days, and 36 weeks, 0 days, of gestation.

Antenatal corticosteroid administration was regarded as effective if a newborn did not require treatment in the first 72 hours for respiratory distress or illness. Treatment could include “continuous positive airway pressure or high-flow nasal cannula for 2 hours or more, supplemental oxygen with a fraction of inspired oxygen of 30% or more for 4 hours or more, and extracorporeal membrane oxygenation or mechanical ventilation,” Dr. Gyamfi-Bannerman and her associates wrote.

To tally the costs, the researchers used Medicaid rates to estimate the total in 2015 U.S. dollars for betamethasone, outpatient visits or inpatient stays to administer it, and all direct newborn care costs, including neonatal ICU daily costs stratified by respiratory illness severity. Betamethasone administration included an initial 12-mg intramuscular dose followed by another after 24 hours if the infant had not been delivered.

“Because therapy often persists for longer than this 72-hour duration, we measured costs through hospital discharge,” the authors wrote. “The analysis took the perspective of a third-party payer in which we included direct medical costs and associated overhead accruing to hospitals and medical payers for the care of enrolled patients and their infants.”

Among 2,821 mothers not lost to follow-up during the secondary analysis, 1,426 received betamethasone and 1,395 received placebo. For mothers who received betamethasone antenatally, the total mean cost was $4,681 per mother-infant pair. Total mean cost for those in the placebo group was $5,379 per pair, resulting in a significant mean $698 savings (P = .02). Respiratory morbidity was 2.9% lower in infants whose mothers received antenatal corticosteroid treatment.

“Thus, because the treated group had lower costs and this strategy was more effective, administration of betamethasone to women at risk for late preterm birth was judged to be a dominant strategy, which is defined as one in which costs are lower and effectiveness is higher than a comparator (incremental cost-effectiveness ratio [ICER], −23 986),” Dr. Gyamfi-Bannerman and her associates reported. ICER is defined as the difference in mean total cost per patient in the betamethasone and placebo arms divided by the difference in the effectiveness.

Study limitations were an inability to estimate costs according to quality-adjusted life years or to include families’/caregivers’ costs.

SOURCE: Gyamfi-Bannerman C. JAMA Pediatr. 2019 Mar 11. doi: 10.1001/jamapediatrics.2019.0032.

Administering antenatal corticosteroids to pregnant women at high risk for preterm birth was a cost-effective intervention that improved infant respiratory outcomes, according to a new study.

“This intervention has a potential cost saving in the United States of approximately $100 million dollars annually from the benefit in the immediate neonatal outcome alone,” Cynthia Gyamfi-Bannerman, MD, of Columbia University, New York, and her associates reported in JAMA Pediatrics. “Because late preterm birth comprises a large proportion of all preterm births, our findings have the potential for a large influence on public health.”

The researchers conducted a retrospective secondary analysis of the randomized Antenatal Late Preterm Steroids (ALPS) clinical trial October 2010 to February 2015. The trial enrolled randomly assigned antenatal administration of betamethasone or placebo to women pregnant with a singleton and at high risk for preterm birth while between 34 weeks, 6 days, and 36 weeks, 0 days, of gestation.

Antenatal corticosteroid administration was regarded as effective if a newborn did not require treatment in the first 72 hours for respiratory distress or illness. Treatment could include “continuous positive airway pressure or high-flow nasal cannula for 2 hours or more, supplemental oxygen with a fraction of inspired oxygen of 30% or more for 4 hours or more, and extracorporeal membrane oxygenation or mechanical ventilation,” Dr. Gyamfi-Bannerman and her associates wrote.

To tally the costs, the researchers used Medicaid rates to estimate the total in 2015 U.S. dollars for betamethasone, outpatient visits or inpatient stays to administer it, and all direct newborn care costs, including neonatal ICU daily costs stratified by respiratory illness severity. Betamethasone administration included an initial 12-mg intramuscular dose followed by another after 24 hours if the infant had not been delivered.

“Because therapy often persists for longer than this 72-hour duration, we measured costs through hospital discharge,” the authors wrote. “The analysis took the perspective of a third-party payer in which we included direct medical costs and associated overhead accruing to hospitals and medical payers for the care of enrolled patients and their infants.”

Among 2,821 mothers not lost to follow-up during the secondary analysis, 1,426 received betamethasone and 1,395 received placebo. For mothers who received betamethasone antenatally, the total mean cost was $4,681 per mother-infant pair. Total mean cost for those in the placebo group was $5,379 per pair, resulting in a significant mean $698 savings (P = .02). Respiratory morbidity was 2.9% lower in infants whose mothers received antenatal corticosteroid treatment.

“Thus, because the treated group had lower costs and this strategy was more effective, administration of betamethasone to women at risk for late preterm birth was judged to be a dominant strategy, which is defined as one in which costs are lower and effectiveness is higher than a comparator (incremental cost-effectiveness ratio [ICER], −23 986),” Dr. Gyamfi-Bannerman and her associates reported. ICER is defined as the difference in mean total cost per patient in the betamethasone and placebo arms divided by the difference in the effectiveness.

Study limitations were an inability to estimate costs according to quality-adjusted life years or to include families’/caregivers’ costs.

SOURCE: Gyamfi-Bannerman C. JAMA Pediatr. 2019 Mar 11. doi: 10.1001/jamapediatrics.2019.0032.

Administering antenatal corticosteroids to pregnant women at high risk for preterm birth was a cost-effective intervention that improved infant respiratory outcomes, according to a new study.

“This intervention has a potential cost saving in the United States of approximately $100 million dollars annually from the benefit in the immediate neonatal outcome alone,” Cynthia Gyamfi-Bannerman, MD, of Columbia University, New York, and her associates reported in JAMA Pediatrics. “Because late preterm birth comprises a large proportion of all preterm births, our findings have the potential for a large influence on public health.”

The researchers conducted a retrospective secondary analysis of the randomized Antenatal Late Preterm Steroids (ALPS) clinical trial October 2010 to February 2015. The trial enrolled randomly assigned antenatal administration of betamethasone or placebo to women pregnant with a singleton and at high risk for preterm birth while between 34 weeks, 6 days, and 36 weeks, 0 days, of gestation.

Antenatal corticosteroid administration was regarded as effective if a newborn did not require treatment in the first 72 hours for respiratory distress or illness. Treatment could include “continuous positive airway pressure or high-flow nasal cannula for 2 hours or more, supplemental oxygen with a fraction of inspired oxygen of 30% or more for 4 hours or more, and extracorporeal membrane oxygenation or mechanical ventilation,” Dr. Gyamfi-Bannerman and her associates wrote.

To tally the costs, the researchers used Medicaid rates to estimate the total in 2015 U.S. dollars for betamethasone, outpatient visits or inpatient stays to administer it, and all direct newborn care costs, including neonatal ICU daily costs stratified by respiratory illness severity. Betamethasone administration included an initial 12-mg intramuscular dose followed by another after 24 hours if the infant had not been delivered.

“Because therapy often persists for longer than this 72-hour duration, we measured costs through hospital discharge,” the authors wrote. “The analysis took the perspective of a third-party payer in which we included direct medical costs and associated overhead accruing to hospitals and medical payers for the care of enrolled patients and their infants.”

Among 2,821 mothers not lost to follow-up during the secondary analysis, 1,426 received betamethasone and 1,395 received placebo. For mothers who received betamethasone antenatally, the total mean cost was $4,681 per mother-infant pair. Total mean cost for those in the placebo group was $5,379 per pair, resulting in a significant mean $698 savings (P = .02). Respiratory morbidity was 2.9% lower in infants whose mothers received antenatal corticosteroid treatment.

“Thus, because the treated group had lower costs and this strategy was more effective, administration of betamethasone to women at risk for late preterm birth was judged to be a dominant strategy, which is defined as one in which costs are lower and effectiveness is higher than a comparator (incremental cost-effectiveness ratio [ICER], −23 986),” Dr. Gyamfi-Bannerman and her associates reported. ICER is defined as the difference in mean total cost per patient in the betamethasone and placebo arms divided by the difference in the effectiveness.

Study limitations were an inability to estimate costs according to quality-adjusted life years or to include families’/caregivers’ costs.

SOURCE: Gyamfi-Bannerman C. JAMA Pediatr. 2019 Mar 11. doi: 10.1001/jamapediatrics.2019.0032.

Daily aspirin use could reduce the risk of acute exacerbations of chronic obstructive pulmonary disease, new data suggest.

copyright Darren Hester/Fotolia.com

Researchers reported the outcomes of an observational cohort study of 1,698 individuals with COPD, 45% of whom said they were taking daily aspirin at baseline. Their findings were published in Chest.

After a median follow up of 2.7 years, aspirin users had an overall 22% lower incidence of acute COPD exacerbations compared with nonusers. This was largely accounted for by a 25% reduction in moderate exacerbations, but there was no significant difference between aspirin users and nonusers in severe exacerbations.

A similar pattern was seen after just 1 year of follow-up, with an overall 30% reduction in the incidence of exacerbations, a 37% reduction in moderate exacerbations, but no significant reduction in severe exacerbations.

“Though aspirin use has previously been linked with reduced mortality risk in patients with COPD, to our knowledge, this is the first study to investigate the association of daily aspirin use with respiratory morbidity in COPD,” wrote Ashraf Fawzy, MD, of the division of pulmonary and critical care medicine at Johns Hopkins University, Baltimore, and his coauthors.

The association between aspirin use and reduced incidence of exacerbations was stronger among individuals with chronic bronchitis, which prompted the authors to suggest that future studies of aspirin in COPD should focus on participants with chronic bronchitis.

However, the association was not affected by COPD severity, emphysema presence or severity, or cardiometabolic phenotype.

Aspirin users reported better respiratory-specific quality of life than that of nonusers, including 34% lower odds of reporting moderate to severe dyspnea, and better baseline COPD health status.

“Findings of this study add to the existing literature by highlighting that aspirin use is also associated with reduced respiratory morbidity across several domains – including exacerbation risk, quality of life, and dyspnea – factors related to patient well-being and healthcare utilization,” the authors wrote.

Aspirin users were more likely to be white, male, and obese, and less likely to be smokers. They had better lung function but more cardiovascular comorbidities at baseline, although the aspirin users and nonusers were matched on baseline characteristics.

Speculating on the mechanisms by which aspirin might impact COPD exacerbations, the authors noted that the drug has both systemic and local pulmonary mechanisms of action.

For example, a pathway that results in elevated levels of a urinary metabolite in patients with COPD is irreversibly blocked by aspirin. Aspirin also attenuates the elevation of inflammatory markers interleukin-6 and C-reactive protein, which are part of the inflammatory phenotype of COPD. Aspirin has been shown to reduce proinflammatory cytokines in the lung.

The authors did note that aspirin use was self-reported, so they did not have data on dosage or duration of use.

The National Institutes of Health funded the study. Six authors declared advisory board positions, research support, and other funding from the pharmaceutical sector. One author was also a founder of a company commercializing lung image analysis software. No other conflicts of interest were declared.

SOURCE: Fawzy A et al. Chest. 2019 Mar;155(3): 519-27. doi: 10.1016/j.chest.2018.11.028.

Daily aspirin use could reduce the risk of acute exacerbations of chronic obstructive pulmonary disease, new data suggest.

copyright Darren Hester/Fotolia.com

Researchers reported the outcomes of an observational cohort study of 1,698 individuals with COPD, 45% of whom said they were taking daily aspirin at baseline. Their findings were published in Chest.

After a median follow up of 2.7 years, aspirin users had an overall 22% lower incidence of acute COPD exacerbations compared with nonusers. This was largely accounted for by a 25% reduction in moderate exacerbations, but there was no significant difference between aspirin users and nonusers in severe exacerbations.

A similar pattern was seen after just 1 year of follow-up, with an overall 30% reduction in the incidence of exacerbations, a 37% reduction in moderate exacerbations, but no significant reduction in severe exacerbations.

“Though aspirin use has previously been linked with reduced mortality risk in patients with COPD, to our knowledge, this is the first study to investigate the association of daily aspirin use with respiratory morbidity in COPD,” wrote Ashraf Fawzy, MD, of the division of pulmonary and critical care medicine at Johns Hopkins University, Baltimore, and his coauthors.

The association between aspirin use and reduced incidence of exacerbations was stronger among individuals with chronic bronchitis, which prompted the authors to suggest that future studies of aspirin in COPD should focus on participants with chronic bronchitis.

However, the association was not affected by COPD severity, emphysema presence or severity, or cardiometabolic phenotype.

Aspirin users reported better respiratory-specific quality of life than that of nonusers, including 34% lower odds of reporting moderate to severe dyspnea, and better baseline COPD health status.

“Findings of this study add to the existing literature by highlighting that aspirin use is also associated with reduced respiratory morbidity across several domains – including exacerbation risk, quality of life, and dyspnea – factors related to patient well-being and healthcare utilization,” the authors wrote.

Aspirin users were more likely to be white, male, and obese, and less likely to be smokers. They had better lung function but more cardiovascular comorbidities at baseline, although the aspirin users and nonusers were matched on baseline characteristics.

Speculating on the mechanisms by which aspirin might impact COPD exacerbations, the authors noted that the drug has both systemic and local pulmonary mechanisms of action.

For example, a pathway that results in elevated levels of a urinary metabolite in patients with COPD is irreversibly blocked by aspirin. Aspirin also attenuates the elevation of inflammatory markers interleukin-6 and C-reactive protein, which are part of the inflammatory phenotype of COPD. Aspirin has been shown to reduce proinflammatory cytokines in the lung.

The authors did note that aspirin use was self-reported, so they did not have data on dosage or duration of use.

The National Institutes of Health funded the study. Six authors declared advisory board positions, research support, and other funding from the pharmaceutical sector. One author was also a founder of a company commercializing lung image analysis software. No other conflicts of interest were declared.

SOURCE: Fawzy A et al. Chest. 2019 Mar;155(3): 519-27. doi: 10.1016/j.chest.2018.11.028.

Daily aspirin use could reduce the risk of acute exacerbations of chronic obstructive pulmonary disease, new data suggest.

copyright Darren Hester/Fotolia.com

Researchers reported the outcomes of an observational cohort study of 1,698 individuals with COPD, 45% of whom said they were taking daily aspirin at baseline. Their findings were published in Chest.

After a median follow up of 2.7 years, aspirin users had an overall 22% lower incidence of acute COPD exacerbations compared with nonusers. This was largely accounted for by a 25% reduction in moderate exacerbations, but there was no significant difference between aspirin users and nonusers in severe exacerbations.

A similar pattern was seen after just 1 year of follow-up, with an overall 30% reduction in the incidence of exacerbations, a 37% reduction in moderate exacerbations, but no significant reduction in severe exacerbations.

“Though aspirin use has previously been linked with reduced mortality risk in patients with COPD, to our knowledge, this is the first study to investigate the association of daily aspirin use with respiratory morbidity in COPD,” wrote Ashraf Fawzy, MD, of the division of pulmonary and critical care medicine at Johns Hopkins University, Baltimore, and his coauthors.

The association between aspirin use and reduced incidence of exacerbations was stronger among individuals with chronic bronchitis, which prompted the authors to suggest that future studies of aspirin in COPD should focus on participants with chronic bronchitis.

However, the association was not affected by COPD severity, emphysema presence or severity, or cardiometabolic phenotype.

Aspirin users reported better respiratory-specific quality of life than that of nonusers, including 34% lower odds of reporting moderate to severe dyspnea, and better baseline COPD health status.

“Findings of this study add to the existing literature by highlighting that aspirin use is also associated with reduced respiratory morbidity across several domains – including exacerbation risk, quality of life, and dyspnea – factors related to patient well-being and healthcare utilization,” the authors wrote.

Aspirin users were more likely to be white, male, and obese, and less likely to be smokers. They had better lung function but more cardiovascular comorbidities at baseline, although the aspirin users and nonusers were matched on baseline characteristics.

Speculating on the mechanisms by which aspirin might impact COPD exacerbations, the authors noted that the drug has both systemic and local pulmonary mechanisms of action.

For example, a pathway that results in elevated levels of a urinary metabolite in patients with COPD is irreversibly blocked by aspirin. Aspirin also attenuates the elevation of inflammatory markers interleukin-6 and C-reactive protein, which are part of the inflammatory phenotype of COPD. Aspirin has been shown to reduce proinflammatory cytokines in the lung.

The authors did note that aspirin use was self-reported, so they did not have data on dosage or duration of use.

The National Institutes of Health funded the study. Six authors declared advisory board positions, research support, and other funding from the pharmaceutical sector. One author was also a founder of a company commercializing lung image analysis software. No other conflicts of interest were declared.

SOURCE: Fawzy A et al. Chest. 2019 Mar;155(3): 519-27. doi: 10.1016/j.chest.2018.11.028.