SAN FRANCISCO – In treatment-resistant depression, a switch to a new antidepressant combined with inhaled esketamine (Spravato) led to better symptom improvement than did a switch to a new antidepressant plus placebo, results from a new trial show. The treatment effect of esketamine was modest but had a number needed to treat for remission of just five.

About 30% of patients with major depressive disorder are treatment resistant. They are at risk of suicidal behavior and self-harm during the interval between starting a new medication and onset of efficacy. Esketamine, with its rapid onset of efficacy associated with its stimulation of synaptogenesis through inhibition of the N-methyl-D-aspartate receptor, gained Food and Drug Administration approval in March for the treatment of treatment-resistant depression in adults.

The findings were part of a phase 3 study presented at a press conference at the annual meeting of the American Psychiatric Association and simultaneously published in the American Journal of Psychiatry (2019. doi: 10.1176/appi.ajp.2019.19020172).

Adding esketamine to the start of a new antidepressant was associated with a small improvement in symptoms (effect size, 0.30), and this benefit did not continue to accrue further advantage past the original separation, which led to some skepticism from the author of an accompanying editorial (Am J Psychiatry. 2019 May. doi: 10.1176/appi.ajp.2019.19040423). “The question is, do you need to keep a patient on the drug past 48 hours? There is no statistically significant difference (in patient response) past the first 48 hours. That to me is a concern,” said Alan F. Schatzberg, MD, at the press conference.

Dr. Schatzberg, who is a professor of psychiatry at the Stanford (Calif.) University, also expressed concern about the potential for abuse with esketamine, as well as withdrawal after discontinuation. “I think the drug ought to be used, but it needs to be recommended with considerable caution. We have not answered the many questions that are needed in a drug of potential abuse,” Dr. Schatzberg added.

Study coauthor Michael E. Thase, MD, who also presented at the press conference, discussed the possibility of alterations to the treatment regimen. “I have a hunch you can see this (positive response) within first week or 2, and you can at least concentrate the resource on patients that gain the largest benefit. We can be smarter about it,” said Dr. Thase, who is a professor of psychiatry at the University of Pennsylvania, Philadelphia. He predicted that protocols eventually will be put in place to streamline intranasal ketamine treatment.

Regardless of the effect size, the study produced high remission and response rates in this difficult to treat population, which is welcome news to Gerard Sanacora, MD, PhD, a professor of psychiatry at Yale University, New Haven, Conn., and director of the Yale Depression Research Program. “The response rates that they were seeing are much higher than you would expect,” he said in an interview.

In the phase 3 study, researchers randomized 223 patients from five countries to receive esketamine or placebo, along with either an SSRI (escitalopram or sertraline) or a selective norepinephrine reuptake inhibitor (duloxetine or venlafaxine extended release), based on investigator choice.

To be eligible, participants had to have failed two previous trials of antidepressants. After a 4-week observation period, patients began a 4-week regimen of a new antidepressant combined with twice-weekly nasal esketamine or a placebo.

Subjects in the treatment arm received esketamine on day 1 of the treatment phase with a 56-mg dose. On day 4, 45.8% were increased to a dose of 84 mg, and 66.7% were at the 84-mg dose at the end of the treatment phase.

From baseline to day 28, the esketamine group had a greater decrease in Montgomery-Åsberg Depression Rating Scale (MADRS) score (difference of least square means, –4.0; P = .020; effect size, 0.30). A scatter plot of individual MADRS data during that period revealed rapid onset and increasing rapid response during repeated dosing 24 hours after dosing (least square mean between-group difference, –3.3), day 8 (–2.9), day 15 (–2.0), and day 22 (–4.0; P = .020).

Researchers also examined subjects who achieved at least a 50% reduction MADRS score at day 2 and maintained the improvement at day 28, and the difference was not significant between the two groups. At day 2, 16.5% of esketamine patients achieved a 50% or greater reduction in MADRS, compared with 10.8% in the placebo arm, though the significance of this difference could not be determined.

A post hoc analysis showed that 69.3% of participants in the esketamine group had responded by day 28, compared with 52.0% (odds ratio, 2.4; 95% confidence interval, 1.30-4.54; number needed to treat, 6). More subjects in the treatment group were in remission at day 28 (52.5% vs. 31.0%; NNT, 5).

The most common treatment-emergent adverse events in the esketamine group were dizziness (20.9%), dissociation (26.1%), dysgeusia (24.3%), vertigo (26.1%), and nausea (26.1%).

The study was funded by Janssen Research and Development. Dr. Sanacora was an investigator on previous Janssen-funded studies and has consulted for Janssen. Dr. Schatzberg has received research support from and consulted for Janssen, and has consulted for numerous other companies. Dr. Thase has received research support from Janssen and consulted for a wide range of pharmaceutical companies.
 

SOURCE: Popova V et al. APA 2019, Am J Psychiatry 2019 May. doi: 10.1176/appi.ajp.2019.19020172.

SAN FRANCISCO – In treatment-resistant depression, a switch to a new antidepressant combined with inhaled esketamine (Spravato) led to better symptom improvement than did a switch to a new antidepressant plus placebo, results from a new trial show. The treatment effect of esketamine was modest but had a number needed to treat for remission of just five.

About 30% of patients with major depressive disorder are treatment resistant. They are at risk of suicidal behavior and self-harm during the interval between starting a new medication and onset of efficacy. Esketamine, with its rapid onset of efficacy associated with its stimulation of synaptogenesis through inhibition of the N-methyl-D-aspartate receptor, gained Food and Drug Administration approval in March for the treatment of treatment-resistant depression in adults.

The findings were part of a phase 3 study presented at a press conference at the annual meeting of the American Psychiatric Association and simultaneously published in the American Journal of Psychiatry (2019. doi: 10.1176/appi.ajp.2019.19020172).

Adding esketamine to the start of a new antidepressant was associated with a small improvement in symptoms (effect size, 0.30), and this benefit did not continue to accrue further advantage past the original separation, which led to some skepticism from the author of an accompanying editorial (Am J Psychiatry. 2019 May. doi: 10.1176/appi.ajp.2019.19040423). “The question is, do you need to keep a patient on the drug past 48 hours? There is no statistically significant difference (in patient response) past the first 48 hours. That to me is a concern,” said Alan F. Schatzberg, MD, at the press conference.

Dr. Schatzberg, who is a professor of psychiatry at the Stanford (Calif.) University, also expressed concern about the potential for abuse with esketamine, as well as withdrawal after discontinuation. “I think the drug ought to be used, but it needs to be recommended with considerable caution. We have not answered the many questions that are needed in a drug of potential abuse,” Dr. Schatzberg added.

Study coauthor Michael E. Thase, MD, who also presented at the press conference, discussed the possibility of alterations to the treatment regimen. “I have a hunch you can see this (positive response) within first week or 2, and you can at least concentrate the resource on patients that gain the largest benefit. We can be smarter about it,” said Dr. Thase, who is a professor of psychiatry at the University of Pennsylvania, Philadelphia. He predicted that protocols eventually will be put in place to streamline intranasal ketamine treatment.

Regardless of the effect size, the study produced high remission and response rates in this difficult to treat population, which is welcome news to Gerard Sanacora, MD, PhD, a professor of psychiatry at Yale University, New Haven, Conn., and director of the Yale Depression Research Program. “The response rates that they were seeing are much higher than you would expect,” he said in an interview.

In the phase 3 study, researchers randomized 223 patients from five countries to receive esketamine or placebo, along with either an SSRI (escitalopram or sertraline) or a selective norepinephrine reuptake inhibitor (duloxetine or venlafaxine extended release), based on investigator choice.

To be eligible, participants had to have failed two previous trials of antidepressants. After a 4-week observation period, patients began a 4-week regimen of a new antidepressant combined with twice-weekly nasal esketamine or a placebo.

Subjects in the treatment arm received esketamine on day 1 of the treatment phase with a 56-mg dose. On day 4, 45.8% were increased to a dose of 84 mg, and 66.7% were at the 84-mg dose at the end of the treatment phase.

From baseline to day 28, the esketamine group had a greater decrease in Montgomery-Åsberg Depression Rating Scale (MADRS) score (difference of least square means, –4.0; P = .020; effect size, 0.30). A scatter plot of individual MADRS data during that period revealed rapid onset and increasing rapid response during repeated dosing 24 hours after dosing (least square mean between-group difference, –3.3), day 8 (–2.9), day 15 (–2.0), and day 22 (–4.0; P = .020).

Researchers also examined subjects who achieved at least a 50% reduction MADRS score at day 2 and maintained the improvement at day 28, and the difference was not significant between the two groups. At day 2, 16.5% of esketamine patients achieved a 50% or greater reduction in MADRS, compared with 10.8% in the placebo arm, though the significance of this difference could not be determined.

A post hoc analysis showed that 69.3% of participants in the esketamine group had responded by day 28, compared with 52.0% (odds ratio, 2.4; 95% confidence interval, 1.30-4.54; number needed to treat, 6). More subjects in the treatment group were in remission at day 28 (52.5% vs. 31.0%; NNT, 5).

The most common treatment-emergent adverse events in the esketamine group were dizziness (20.9%), dissociation (26.1%), dysgeusia (24.3%), vertigo (26.1%), and nausea (26.1%).

The study was funded by Janssen Research and Development. Dr. Sanacora was an investigator on previous Janssen-funded studies and has consulted for Janssen. Dr. Schatzberg has received research support from and consulted for Janssen, and has consulted for numerous other companies. Dr. Thase has received research support from Janssen and consulted for a wide range of pharmaceutical companies.
 

SOURCE: Popova V et al. APA 2019, Am J Psychiatry 2019 May. doi: 10.1176/appi.ajp.2019.19020172.

SAN FRANCISCO – In treatment-resistant depression, a switch to a new antidepressant combined with inhaled esketamine (Spravato) led to better symptom improvement than did a switch to a new antidepressant plus placebo, results from a new trial show. The treatment effect of esketamine was modest but had a number needed to treat for remission of just five.

About 30% of patients with major depressive disorder are treatment resistant. They are at risk of suicidal behavior and self-harm during the interval between starting a new medication and onset of efficacy. Esketamine, with its rapid onset of efficacy associated with its stimulation of synaptogenesis through inhibition of the N-methyl-D-aspartate receptor, gained Food and Drug Administration approval in March for the treatment of treatment-resistant depression in adults.

The findings were part of a phase 3 study presented at a press conference at the annual meeting of the American Psychiatric Association and simultaneously published in the American Journal of Psychiatry (2019. doi: 10.1176/appi.ajp.2019.19020172).

Adding esketamine to the start of a new antidepressant was associated with a small improvement in symptoms (effect size, 0.30), and this benefit did not continue to accrue further advantage past the original separation, which led to some skepticism from the author of an accompanying editorial (Am J Psychiatry. 2019 May. doi: 10.1176/appi.ajp.2019.19040423). “The question is, do you need to keep a patient on the drug past 48 hours? There is no statistically significant difference (in patient response) past the first 48 hours. That to me is a concern,” said Alan F. Schatzberg, MD, at the press conference.

Dr. Schatzberg, who is a professor of psychiatry at the Stanford (Calif.) University, also expressed concern about the potential for abuse with esketamine, as well as withdrawal after discontinuation. “I think the drug ought to be used, but it needs to be recommended with considerable caution. We have not answered the many questions that are needed in a drug of potential abuse,” Dr. Schatzberg added.

Study coauthor Michael E. Thase, MD, who also presented at the press conference, discussed the possibility of alterations to the treatment regimen. “I have a hunch you can see this (positive response) within first week or 2, and you can at least concentrate the resource on patients that gain the largest benefit. We can be smarter about it,” said Dr. Thase, who is a professor of psychiatry at the University of Pennsylvania, Philadelphia. He predicted that protocols eventually will be put in place to streamline intranasal ketamine treatment.

Regardless of the effect size, the study produced high remission and response rates in this difficult to treat population, which is welcome news to Gerard Sanacora, MD, PhD, a professor of psychiatry at Yale University, New Haven, Conn., and director of the Yale Depression Research Program. “The response rates that they were seeing are much higher than you would expect,” he said in an interview.

In the phase 3 study, researchers randomized 223 patients from five countries to receive esketamine or placebo, along with either an SSRI (escitalopram or sertraline) or a selective norepinephrine reuptake inhibitor (duloxetine or venlafaxine extended release), based on investigator choice.

To be eligible, participants had to have failed two previous trials of antidepressants. After a 4-week observation period, patients began a 4-week regimen of a new antidepressant combined with twice-weekly nasal esketamine or a placebo.

Subjects in the treatment arm received esketamine on day 1 of the treatment phase with a 56-mg dose. On day 4, 45.8% were increased to a dose of 84 mg, and 66.7% were at the 84-mg dose at the end of the treatment phase.

From baseline to day 28, the esketamine group had a greater decrease in Montgomery-Åsberg Depression Rating Scale (MADRS) score (difference of least square means, –4.0; P = .020; effect size, 0.30). A scatter plot of individual MADRS data during that period revealed rapid onset and increasing rapid response during repeated dosing 24 hours after dosing (least square mean between-group difference, –3.3), day 8 (–2.9), day 15 (–2.0), and day 22 (–4.0; P = .020).

Researchers also examined subjects who achieved at least a 50% reduction MADRS score at day 2 and maintained the improvement at day 28, and the difference was not significant between the two groups. At day 2, 16.5% of esketamine patients achieved a 50% or greater reduction in MADRS, compared with 10.8% in the placebo arm, though the significance of this difference could not be determined.

A post hoc analysis showed that 69.3% of participants in the esketamine group had responded by day 28, compared with 52.0% (odds ratio, 2.4; 95% confidence interval, 1.30-4.54; number needed to treat, 6). More subjects in the treatment group were in remission at day 28 (52.5% vs. 31.0%; NNT, 5).

The most common treatment-emergent adverse events in the esketamine group were dizziness (20.9%), dissociation (26.1%), dysgeusia (24.3%), vertigo (26.1%), and nausea (26.1%).

The study was funded by Janssen Research and Development. Dr. Sanacora was an investigator on previous Janssen-funded studies and has consulted for Janssen. Dr. Schatzberg has received research support from and consulted for Janssen, and has consulted for numerous other companies. Dr. Thase has received research support from Janssen and consulted for a wide range of pharmaceutical companies.
 

SOURCE: Popova V et al. APA 2019, Am J Psychiatry 2019 May. doi: 10.1176/appi.ajp.2019.19020172.

The rate of incoming kindergarteners in California who are up to date on their vaccinations declined in the second year after the passage of state Senate Bill 277, which eliminated nonmedical exemptions from immunizations, according to Paul L. Delamater, PhD, of the University of North Carolina at Chapel Hill, and associates.

The investigators focused on vaccination data collected from 2015 – the last year before the passage of SB 277 – to 2017. They also analyzed county-level data collected from 2000 to 2014 to assess demographic behavior. In 2015, the rate of nonvaccination was 7.15%, decreasing to 4.42% in 2016. This decrease was almost entirely caused by a reduction in the rate of conditional entrants, which fell from 4.43% to 1.91%, and in personal belief exceptions, which fell from 2.37% to 0.56%.

While the rates of conditional entrants and personal belief exceptions continued to fall in 2017, other mechanisms allowed the overall rate of kindergarteners not fully up to date on their vaccines to jump to 4.87%. This was fueled by a slight increase in medical exceptions (from 0.51% in 2016 to 0.73% in 2017), and a significant increase in children who were overdue or exempt, which both increased from 0 in 2014 to over 1% by 2017.

“Although the law was successful in reducing the number of students with personal belief exemptions, our analysis reveals that a replacement effect may have stifled a larger increase in students entering kindergarten who are up to date on vaccination. ... Given these findings, policymakers should consider the various options available to increase vaccination coverage or strategies to minimize potential unintended consequences of eliminating nonmedical exemptions such as the replacement effect observed in California,” the investigators reported in Pediatrics (2019, May 21 doi: 10.1542/peds.2018-3301.

One coauthor reported receiving research and consulting support from Pfizer, Merck, and Walgreens; another reported receiving research support from Pfizer, Merck, GlaxoSmithKline, Sanofi Pasteur, Protein Science (now Sanofi Pasteur), Dynavax, and MedImmune.

[email protected]

The rate of incoming kindergarteners in California who are up to date on their vaccinations declined in the second year after the passage of state Senate Bill 277, which eliminated nonmedical exemptions from immunizations, according to Paul L. Delamater, PhD, of the University of North Carolina at Chapel Hill, and associates.

The investigators focused on vaccination data collected from 2015 – the last year before the passage of SB 277 – to 2017. They also analyzed county-level data collected from 2000 to 2014 to assess demographic behavior. In 2015, the rate of nonvaccination was 7.15%, decreasing to 4.42% in 2016. This decrease was almost entirely caused by a reduction in the rate of conditional entrants, which fell from 4.43% to 1.91%, and in personal belief exceptions, which fell from 2.37% to 0.56%.

While the rates of conditional entrants and personal belief exceptions continued to fall in 2017, other mechanisms allowed the overall rate of kindergarteners not fully up to date on their vaccines to jump to 4.87%. This was fueled by a slight increase in medical exceptions (from 0.51% in 2016 to 0.73% in 2017), and a significant increase in children who were overdue or exempt, which both increased from 0 in 2014 to over 1% by 2017.

“Although the law was successful in reducing the number of students with personal belief exemptions, our analysis reveals that a replacement effect may have stifled a larger increase in students entering kindergarten who are up to date on vaccination. ... Given these findings, policymakers should consider the various options available to increase vaccination coverage or strategies to minimize potential unintended consequences of eliminating nonmedical exemptions such as the replacement effect observed in California,” the investigators reported in Pediatrics (2019, May 21 doi: 10.1542/peds.2018-3301.

One coauthor reported receiving research and consulting support from Pfizer, Merck, and Walgreens; another reported receiving research support from Pfizer, Merck, GlaxoSmithKline, Sanofi Pasteur, Protein Science (now Sanofi Pasteur), Dynavax, and MedImmune.

[email protected]

The rate of incoming kindergarteners in California who are up to date on their vaccinations declined in the second year after the passage of state Senate Bill 277, which eliminated nonmedical exemptions from immunizations, according to Paul L. Delamater, PhD, of the University of North Carolina at Chapel Hill, and associates.

The investigators focused on vaccination data collected from 2015 – the last year before the passage of SB 277 – to 2017. They also analyzed county-level data collected from 2000 to 2014 to assess demographic behavior. In 2015, the rate of nonvaccination was 7.15%, decreasing to 4.42% in 2016. This decrease was almost entirely caused by a reduction in the rate of conditional entrants, which fell from 4.43% to 1.91%, and in personal belief exceptions, which fell from 2.37% to 0.56%.

While the rates of conditional entrants and personal belief exceptions continued to fall in 2017, other mechanisms allowed the overall rate of kindergarteners not fully up to date on their vaccines to jump to 4.87%. This was fueled by a slight increase in medical exceptions (from 0.51% in 2016 to 0.73% in 2017), and a significant increase in children who were overdue or exempt, which both increased from 0 in 2014 to over 1% by 2017.

“Although the law was successful in reducing the number of students with personal belief exemptions, our analysis reveals that a replacement effect may have stifled a larger increase in students entering kindergarten who are up to date on vaccination. ... Given these findings, policymakers should consider the various options available to increase vaccination coverage or strategies to minimize potential unintended consequences of eliminating nonmedical exemptions such as the replacement effect observed in California,” the investigators reported in Pediatrics (2019, May 21 doi: 10.1542/peds.2018-3301.

One coauthor reported receiving research and consulting support from Pfizer, Merck, and Walgreens; another reported receiving research support from Pfizer, Merck, GlaxoSmithKline, Sanofi Pasteur, Protein Science (now Sanofi Pasteur), Dynavax, and MedImmune.

[email protected]

DALLAS – Nintedanib, a tyrosine kinase inhibitor, decreased by 44% the annual rate of lung function decline among patients with interstitial lung disease associated with systemic sclerosis, a year-long study has found.

Michele G. Sullivan/MDedge News

In a placebo-controlled 52-week trial, forced vital capacity (FVC) in patients who took nintedanib (Ofev) declined by a mean of 52 mL – significantly less than the mean 93 mL decline seen among those who were given placebo, Oliver Distler, MD, said at the annual meeting of the American Thoracic Society.

“These are people in their mid-40s and -50s,” said Dr. Distler of the University of Zürich. “They have a long time to go. If there is an annual preservation of lung function by 40%, if you have that every year, it becomes very surely clinically significant. A decline in FVC is also a good surrogate marker of mortality in interstitial lung disease associated with systemic sclerosis. Assuming the effects are ongoing above the 1 year we looked at, then indeed these results are clinically important.”

The study was simultaneously published in the New England Journal of Medicine. Nintedanib is already approved for idiopathic pulmonary fibrosis. But some data suggest that it also exerts antifibrotic and anti-inflammatory effects in animal models of systemic sclerosis and inflammatory lung disease (ILD). SENSCIS (the Safety and Efficacy of Nintedanib in Systemic Sclerosis trial) investigated the molecule’s use in patients with ILD associated with systemic sclerosis.

Conducted in 32 countries, SENSCIS comprised 576 patients with the disorder, whose sclerosis affected at least 10% of their lungs. They were assigned to 52 weeks of either placebo or 150 mg nintedanib twice weekly. However, patients stayed on their blinded treatment until the last patient enrolled had finished the year of treatment; some patients took the drug for 100 weeks, Dr. Distler said. The primary endpoint was annual rate of decline in the forced vital capacity (FEV). Secondary endpoints included changes of the modified Rodnan skin score and in the total score on the St. George’s Respiratory Questionnaire.

Patients were a mean of 54 years old, with a mean disease duration of about 3 years. About half had diffuse cutaneous systemic sclerosis; the sclerosis was limited in the remainder. The mean extent of lung fibrosis was about 36%. Half were taking mycophenolate at baseline, which was allowed as background treatment, along with up to 10 mg/day of prednisone. Any patient who experienced clinically significant lung function deterioration could receive additional therapy at the investigator’s discretion.

The mean baseline FEV for these patients was 72.5% of predicted value. The mean diffusing capacity of the lungs for carbon monoxide was 53% of expected capacity.

Most patients completed the study (80% of the active group and 89% of the placebo group). The mean drug exposure duration was 10 months in the active group and 11 in the placebo group.

Improvement began early in treatment, with the efficacy curves separating by week 12 and continuing to diverge. After 52 weeks of therapy, the annual rate of change was 41 mL less in the active group than in the placebo group (–54.4 mL vs. –93.3 mL). The mean adjusted absolute change from baseline was –54.6 mL in the active group and –101 mL in the placebo at week 52. Significantly fewer patients taking nintedanib also lost more than 10% of FVC by week 52 (16.7% vs. 18%).

The St. George’s Respiratory Questionnaire score improved about one point in the active group and declined about one point in the placebo group.

Nintedanib was equally effective across a number of subgroups, including those divided by sex, age, and race. Antitopoisomerase antibodies and so-called antitopoisomerase I antibody status did not affect nintedanib’s action. Nintedanib also significantly improved scores on the Health Assessment Questionnaire without Disability Index and dyspnea.

More patients in the active group than in on placebo discontinued treatment because of a serious adverse event (16% vs. 8.7%). The most common of these were diarrhea (75.7% vs. 31%), nausea (31.6% vs. 13.5%), and vomiting (24.7% vs.10.4%). Skin ulcers occurred in about 18% of each group. Patients in the active group were significantly more likely to develop elevated alanine and aspartate aminotransferase of up to three times normal levels (4.9% vs. 0.7%).

Treatment did not significantly affect mortality rates, however. Over the treatment period, 10 patients in the nintedanib group and 9 in the placebo group died (3.5% vs. 3.1%).

The study was sponsored by Boehringer Ingelheim. Dr. Distler was the primary investigator on the trial.

[email protected]

SOURCE: Distler O et al. ATS 2019, Abstract A7360.

DALLAS – Nintedanib, a tyrosine kinase inhibitor, decreased by 44% the annual rate of lung function decline among patients with interstitial lung disease associated with systemic sclerosis, a year-long study has found.

Michele G. Sullivan/MDedge News

In a placebo-controlled 52-week trial, forced vital capacity (FVC) in patients who took nintedanib (Ofev) declined by a mean of 52 mL – significantly less than the mean 93 mL decline seen among those who were given placebo, Oliver Distler, MD, said at the annual meeting of the American Thoracic Society.

“These are people in their mid-40s and -50s,” said Dr. Distler of the University of Zürich. “They have a long time to go. If there is an annual preservation of lung function by 40%, if you have that every year, it becomes very surely clinically significant. A decline in FVC is also a good surrogate marker of mortality in interstitial lung disease associated with systemic sclerosis. Assuming the effects are ongoing above the 1 year we looked at, then indeed these results are clinically important.”

The study was simultaneously published in the New England Journal of Medicine. Nintedanib is already approved for idiopathic pulmonary fibrosis. But some data suggest that it also exerts antifibrotic and anti-inflammatory effects in animal models of systemic sclerosis and inflammatory lung disease (ILD). SENSCIS (the Safety and Efficacy of Nintedanib in Systemic Sclerosis trial) investigated the molecule’s use in patients with ILD associated with systemic sclerosis.

Conducted in 32 countries, SENSCIS comprised 576 patients with the disorder, whose sclerosis affected at least 10% of their lungs. They were assigned to 52 weeks of either placebo or 150 mg nintedanib twice weekly. However, patients stayed on their blinded treatment until the last patient enrolled had finished the year of treatment; some patients took the drug for 100 weeks, Dr. Distler said. The primary endpoint was annual rate of decline in the forced vital capacity (FEV). Secondary endpoints included changes of the modified Rodnan skin score and in the total score on the St. George’s Respiratory Questionnaire.

Patients were a mean of 54 years old, with a mean disease duration of about 3 years. About half had diffuse cutaneous systemic sclerosis; the sclerosis was limited in the remainder. The mean extent of lung fibrosis was about 36%. Half were taking mycophenolate at baseline, which was allowed as background treatment, along with up to 10 mg/day of prednisone. Any patient who experienced clinically significant lung function deterioration could receive additional therapy at the investigator’s discretion.

The mean baseline FEV for these patients was 72.5% of predicted value. The mean diffusing capacity of the lungs for carbon monoxide was 53% of expected capacity.

Most patients completed the study (80% of the active group and 89% of the placebo group). The mean drug exposure duration was 10 months in the active group and 11 in the placebo group.

Improvement began early in treatment, with the efficacy curves separating by week 12 and continuing to diverge. After 52 weeks of therapy, the annual rate of change was 41 mL less in the active group than in the placebo group (–54.4 mL vs. –93.3 mL). The mean adjusted absolute change from baseline was –54.6 mL in the active group and –101 mL in the placebo at week 52. Significantly fewer patients taking nintedanib also lost more than 10% of FVC by week 52 (16.7% vs. 18%).

The St. George’s Respiratory Questionnaire score improved about one point in the active group and declined about one point in the placebo group.

Nintedanib was equally effective across a number of subgroups, including those divided by sex, age, and race. Antitopoisomerase antibodies and so-called antitopoisomerase I antibody status did not affect nintedanib’s action. Nintedanib also significantly improved scores on the Health Assessment Questionnaire without Disability Index and dyspnea.

More patients in the active group than in on placebo discontinued treatment because of a serious adverse event (16% vs. 8.7%). The most common of these were diarrhea (75.7% vs. 31%), nausea (31.6% vs. 13.5%), and vomiting (24.7% vs.10.4%). Skin ulcers occurred in about 18% of each group. Patients in the active group were significantly more likely to develop elevated alanine and aspartate aminotransferase of up to three times normal levels (4.9% vs. 0.7%).

Treatment did not significantly affect mortality rates, however. Over the treatment period, 10 patients in the nintedanib group and 9 in the placebo group died (3.5% vs. 3.1%).

The study was sponsored by Boehringer Ingelheim. Dr. Distler was the primary investigator on the trial.

[email protected]

SOURCE: Distler O et al. ATS 2019, Abstract A7360.

DALLAS – Nintedanib, a tyrosine kinase inhibitor, decreased by 44% the annual rate of lung function decline among patients with interstitial lung disease associated with systemic sclerosis, a year-long study has found.

Michele G. Sullivan/MDedge News

In a placebo-controlled 52-week trial, forced vital capacity (FVC) in patients who took nintedanib (Ofev) declined by a mean of 52 mL – significantly less than the mean 93 mL decline seen among those who were given placebo, Oliver Distler, MD, said at the annual meeting of the American Thoracic Society.

“These are people in their mid-40s and -50s,” said Dr. Distler of the University of Zürich. “They have a long time to go. If there is an annual preservation of lung function by 40%, if you have that every year, it becomes very surely clinically significant. A decline in FVC is also a good surrogate marker of mortality in interstitial lung disease associated with systemic sclerosis. Assuming the effects are ongoing above the 1 year we looked at, then indeed these results are clinically important.”

The study was simultaneously published in the New England Journal of Medicine. Nintedanib is already approved for idiopathic pulmonary fibrosis. But some data suggest that it also exerts antifibrotic and anti-inflammatory effects in animal models of systemic sclerosis and inflammatory lung disease (ILD). SENSCIS (the Safety and Efficacy of Nintedanib in Systemic Sclerosis trial) investigated the molecule’s use in patients with ILD associated with systemic sclerosis.

Conducted in 32 countries, SENSCIS comprised 576 patients with the disorder, whose sclerosis affected at least 10% of their lungs. They were assigned to 52 weeks of either placebo or 150 mg nintedanib twice weekly. However, patients stayed on their blinded treatment until the last patient enrolled had finished the year of treatment; some patients took the drug for 100 weeks, Dr. Distler said. The primary endpoint was annual rate of decline in the forced vital capacity (FEV). Secondary endpoints included changes of the modified Rodnan skin score and in the total score on the St. George’s Respiratory Questionnaire.

Patients were a mean of 54 years old, with a mean disease duration of about 3 years. About half had diffuse cutaneous systemic sclerosis; the sclerosis was limited in the remainder. The mean extent of lung fibrosis was about 36%. Half were taking mycophenolate at baseline, which was allowed as background treatment, along with up to 10 mg/day of prednisone. Any patient who experienced clinically significant lung function deterioration could receive additional therapy at the investigator’s discretion.

The mean baseline FEV for these patients was 72.5% of predicted value. The mean diffusing capacity of the lungs for carbon monoxide was 53% of expected capacity.

Most patients completed the study (80% of the active group and 89% of the placebo group). The mean drug exposure duration was 10 months in the active group and 11 in the placebo group.

Improvement began early in treatment, with the efficacy curves separating by week 12 and continuing to diverge. After 52 weeks of therapy, the annual rate of change was 41 mL less in the active group than in the placebo group (–54.4 mL vs. –93.3 mL). The mean adjusted absolute change from baseline was –54.6 mL in the active group and –101 mL in the placebo at week 52. Significantly fewer patients taking nintedanib also lost more than 10% of FVC by week 52 (16.7% vs. 18%).

The St. George’s Respiratory Questionnaire score improved about one point in the active group and declined about one point in the placebo group.

Nintedanib was equally effective across a number of subgroups, including those divided by sex, age, and race. Antitopoisomerase antibodies and so-called antitopoisomerase I antibody status did not affect nintedanib’s action. Nintedanib also significantly improved scores on the Health Assessment Questionnaire without Disability Index and dyspnea.

More patients in the active group than in on placebo discontinued treatment because of a serious adverse event (16% vs. 8.7%). The most common of these were diarrhea (75.7% vs. 31%), nausea (31.6% vs. 13.5%), and vomiting (24.7% vs.10.4%). Skin ulcers occurred in about 18% of each group. Patients in the active group were significantly more likely to develop elevated alanine and aspartate aminotransferase of up to three times normal levels (4.9% vs. 0.7%).

Treatment did not significantly affect mortality rates, however. Over the treatment period, 10 patients in the nintedanib group and 9 in the placebo group died (3.5% vs. 3.1%).

The study was sponsored by Boehringer Ingelheim. Dr. Distler was the primary investigator on the trial.

[email protected]

SOURCE: Distler O et al. ATS 2019, Abstract A7360.

Organized sports can develop not only the physical, but the social, psychological, and emotional health of children, according to a clinical report from the American Academy of Pediatrics’ Council on Sports Medicine and Fitness.

james boulette/Thinkstock

In the report, “Organized Sports for Children, Preadolescents, and Adolescents,” published online in Pediatrics, the authors addressed the risks and benefits of organized sports for children and teens and offered guidance for how clinicians, schools, and communities can involve more children in sports programs.

The authors emphasized the role of free play and the development of skills for children younger than 6 years. However, they wrote that you and parents should encourage organized sports – with emphasis on physical activity enjoyment – for children older than 6 years at a range of skill levels.

“Aspects of readiness to consider are motor skill acquisition, ability to combine those skills, and attention span,” according to the authors, who noted that most children younger than 6 years may not yet have the skills and attention for organized sports.

You also can remind parents to step back from pushing children into particular sports. Allowing children to choose which activities to try helps keep the focus on fun, even if the child’s idea of fun may differ from parental ideas. “Forcing children to participate in organized sports (or any physical activity) is likely to decrease fun in the activity and discourage future participation,” according to the authors.

They recognize barriers to organized sports for children from low socioeconomic backgrounds and advise communities to try to reduce them; other recommendations include having more options for organized sports at a range of skill levels to encourage participation and long-term involvement, and promoting physical activity.

“If we offer children a variety of sports for all skill levels, they are more likely to try new activities and stick with the ones they enjoy,” Kelsey Logan, MD, a coauthor of the report, said in a statement. “The interest should start with the child, not the parent.”

“Families can help by encouraging children to ‘sample’ sports, so they can figure out what they find enjoyable,” he said. “Ideally, there is an activity for everyone, with the focus on having fun.”

“Given the epidemic of obesity and all of its accompanying medical conditions, it is important to find ways to keep kids physically active. Organized sports participation is one tactic to accomplish this,” the authors said.

They acknowledge the potential risks involved in organized sports such as sports injuries, bullying, and burnout, but also advise empowering parents to support a positive coaching environment with playing time for all participants so they can enjoy the physical and mental benefits of being on a team.

“Young athletes typically learn skills and values that they can use in everyday life,” Steven Cuff, MD, coauthor of the report, said in a statement. “The camaraderie and teamwork needed on a playing field offers lasting lessons on personal responsibility, sportsmanship, goal-setting, and emotional control.”

Children with developmental and neurologic disabilities also can benefit from organized sports participation in programs such as Special Olympics, the authors said.

The report authors had no financial conflicts to disclose.

SOURCE: Logan K et al. Pediatrics. 2019 May 20. doi: 10.1542/peds.2019-0997.

Organized sports can develop not only the physical, but the social, psychological, and emotional health of children, according to a clinical report from the American Academy of Pediatrics’ Council on Sports Medicine and Fitness.

james boulette/Thinkstock

In the report, “Organized Sports for Children, Preadolescents, and Adolescents,” published online in Pediatrics, the authors addressed the risks and benefits of organized sports for children and teens and offered guidance for how clinicians, schools, and communities can involve more children in sports programs.

The authors emphasized the role of free play and the development of skills for children younger than 6 years. However, they wrote that you and parents should encourage organized sports – with emphasis on physical activity enjoyment – for children older than 6 years at a range of skill levels.

“Aspects of readiness to consider are motor skill acquisition, ability to combine those skills, and attention span,” according to the authors, who noted that most children younger than 6 years may not yet have the skills and attention for organized sports.

You also can remind parents to step back from pushing children into particular sports. Allowing children to choose which activities to try helps keep the focus on fun, even if the child’s idea of fun may differ from parental ideas. “Forcing children to participate in organized sports (or any physical activity) is likely to decrease fun in the activity and discourage future participation,” according to the authors.

They recognize barriers to organized sports for children from low socioeconomic backgrounds and advise communities to try to reduce them; other recommendations include having more options for organized sports at a range of skill levels to encourage participation and long-term involvement, and promoting physical activity.

“If we offer children a variety of sports for all skill levels, they are more likely to try new activities and stick with the ones they enjoy,” Kelsey Logan, MD, a coauthor of the report, said in a statement. “The interest should start with the child, not the parent.”

“Families can help by encouraging children to ‘sample’ sports, so they can figure out what they find enjoyable,” he said. “Ideally, there is an activity for everyone, with the focus on having fun.”

“Given the epidemic of obesity and all of its accompanying medical conditions, it is important to find ways to keep kids physically active. Organized sports participation is one tactic to accomplish this,” the authors said.

They acknowledge the potential risks involved in organized sports such as sports injuries, bullying, and burnout, but also advise empowering parents to support a positive coaching environment with playing time for all participants so they can enjoy the physical and mental benefits of being on a team.

“Young athletes typically learn skills and values that they can use in everyday life,” Steven Cuff, MD, coauthor of the report, said in a statement. “The camaraderie and teamwork needed on a playing field offers lasting lessons on personal responsibility, sportsmanship, goal-setting, and emotional control.”

Children with developmental and neurologic disabilities also can benefit from organized sports participation in programs such as Special Olympics, the authors said.

The report authors had no financial conflicts to disclose.

SOURCE: Logan K et al. Pediatrics. 2019 May 20. doi: 10.1542/peds.2019-0997.

Organized sports can develop not only the physical, but the social, psychological, and emotional health of children, according to a clinical report from the American Academy of Pediatrics’ Council on Sports Medicine and Fitness.

james boulette/Thinkstock

In the report, “Organized Sports for Children, Preadolescents, and Adolescents,” published online in Pediatrics, the authors addressed the risks and benefits of organized sports for children and teens and offered guidance for how clinicians, schools, and communities can involve more children in sports programs.

The authors emphasized the role of free play and the development of skills for children younger than 6 years. However, they wrote that you and parents should encourage organized sports – with emphasis on physical activity enjoyment – for children older than 6 years at a range of skill levels.

“Aspects of readiness to consider are motor skill acquisition, ability to combine those skills, and attention span,” according to the authors, who noted that most children younger than 6 years may not yet have the skills and attention for organized sports.

You also can remind parents to step back from pushing children into particular sports. Allowing children to choose which activities to try helps keep the focus on fun, even if the child’s idea of fun may differ from parental ideas. “Forcing children to participate in organized sports (or any physical activity) is likely to decrease fun in the activity and discourage future participation,” according to the authors.

They recognize barriers to organized sports for children from low socioeconomic backgrounds and advise communities to try to reduce them; other recommendations include having more options for organized sports at a range of skill levels to encourage participation and long-term involvement, and promoting physical activity.

“If we offer children a variety of sports for all skill levels, they are more likely to try new activities and stick with the ones they enjoy,” Kelsey Logan, MD, a coauthor of the report, said in a statement. “The interest should start with the child, not the parent.”

“Families can help by encouraging children to ‘sample’ sports, so they can figure out what they find enjoyable,” he said. “Ideally, there is an activity for everyone, with the focus on having fun.”

“Given the epidemic of obesity and all of its accompanying medical conditions, it is important to find ways to keep kids physically active. Organized sports participation is one tactic to accomplish this,” the authors said.

They acknowledge the potential risks involved in organized sports such as sports injuries, bullying, and burnout, but also advise empowering parents to support a positive coaching environment with playing time for all participants so they can enjoy the physical and mental benefits of being on a team.

“Young athletes typically learn skills and values that they can use in everyday life,” Steven Cuff, MD, coauthor of the report, said in a statement. “The camaraderie and teamwork needed on a playing field offers lasting lessons on personal responsibility, sportsmanship, goal-setting, and emotional control.”

Children with developmental and neurologic disabilities also can benefit from organized sports participation in programs such as Special Olympics, the authors said.

The report authors had no financial conflicts to disclose.

SOURCE: Logan K et al. Pediatrics. 2019 May 20. doi: 10.1542/peds.2019-0997.

SAN FRANCISCO – Children who witnessed the 9/11 attacks on the World Trade Center are almost fivefold as likely to suffer comorbid physical and psychiatric problems as adults, according to a case-control study presented at the American Psychiatric Association annual meeting.

The investigation included 942 people who, as children under 18 years old, were in school below Canal Street in lower Manhattan when the World Trade Center was attacked. They saw the towers collapse and were evacuated from the area, but did not lose a parent. Now 18-36 years old, they were interviewed in their homes and asked to filled out questionnaires about psychiatric and physical problems. The outcomes were compared with 563 age- and gender-matched controls who were in school in Queens at the time.

In turns out that “it made a huge difference whether you were there or not. Being there had much more impact than hearing about it or watching it on TV,” said lead investigator Lawrence Amsel, MD, an assistant professor of clinical psychiatry at Columbia University in New York.

Adults who witnessed the attacks as children were more than twice as likely to have panic disorder, marijuana use disorder, and separation anxiety, which is uncommon in adults; anxiety disorders were more prevalent, as well.

They also were almost half as likely to be living with a spouse or partner, and half as likely to be living independently. “That kind of goes along with the separation anxiety; these kids were more likely to be afraid of moving away from their family and breaking out into their own lives,” Dr. Amsel said.

Overall, 36% had a psychiatric disorder, and 27% had a physical problem, such as diabetes, asthma, or eczema; 14% had both. Among adults who were in Queens during the attacks, 28% had a psychiatric disorder, and 11% a physical problem; 4% were comorbid.

The increased odds of physical-psychiatric comorbidity among witnesses (adjusted odds ratio, 4.60; 95% confidence interval, 2.75- 7.71; P less than .0001) “was not due simply to an increase in physical conditions,” according to the study team.

“This was a single event,” Dr. Amsel said, but for children who witnessed it, “it’s had effects for decades. There were huge amounts of money sent in, and lots of health care for kids who were down there, but despite that, we have this. We think the PTSD morphed into” long-term issues, Dr. Amsel said.

“We know that one of the reasons people get psychiatric disorders” after trauma “is that they generalize the fear; the message to your brain is that everything is dangerous. You’ve got to intervene there and break the association between the fear system and everything else, so that life is still safe,” he said.

There’s an added element with human violence. “Life may be unsafe” after a natural disaster, “but you know that human beings are good and helpful. With a terrorist attack, you stop trusting people,” he said.

Cognitive behavioral therapy could help, among other approaches. It also might be helpful to teach resilience to schoolchildren, just like biology and algebra, he said.

Cases and controls were evenly split between the sexes. Just over 40% of subjects in both groups were white, followed by Hispanics, Asians, and blacks. The majority of households were middle income.

The next step is to break the results down by age, ethnicity, socioeconomic factors, and support systems. The team will run blood work and heart and lung tests on the subjects to nail down the physical problems reported by witnesses. There are concerns about the lingering effects of the dust plume.

The work is funded by the federal government. Dr. Amsel didn’t have any relevant financial disclosures.

[email protected]

SAN FRANCISCO – Children who witnessed the 9/11 attacks on the World Trade Center are almost fivefold as likely to suffer comorbid physical and psychiatric problems as adults, according to a case-control study presented at the American Psychiatric Association annual meeting.

The investigation included 942 people who, as children under 18 years old, were in school below Canal Street in lower Manhattan when the World Trade Center was attacked. They saw the towers collapse and were evacuated from the area, but did not lose a parent. Now 18-36 years old, they were interviewed in their homes and asked to filled out questionnaires about psychiatric and physical problems. The outcomes were compared with 563 age- and gender-matched controls who were in school in Queens at the time.

In turns out that “it made a huge difference whether you were there or not. Being there had much more impact than hearing about it or watching it on TV,” said lead investigator Lawrence Amsel, MD, an assistant professor of clinical psychiatry at Columbia University in New York.

Adults who witnessed the attacks as children were more than twice as likely to have panic disorder, marijuana use disorder, and separation anxiety, which is uncommon in adults; anxiety disorders were more prevalent, as well.

They also were almost half as likely to be living with a spouse or partner, and half as likely to be living independently. “That kind of goes along with the separation anxiety; these kids were more likely to be afraid of moving away from their family and breaking out into their own lives,” Dr. Amsel said.

Overall, 36% had a psychiatric disorder, and 27% had a physical problem, such as diabetes, asthma, or eczema; 14% had both. Among adults who were in Queens during the attacks, 28% had a psychiatric disorder, and 11% a physical problem; 4% were comorbid.

The increased odds of physical-psychiatric comorbidity among witnesses (adjusted odds ratio, 4.60; 95% confidence interval, 2.75- 7.71; P less than .0001) “was not due simply to an increase in physical conditions,” according to the study team.

“This was a single event,” Dr. Amsel said, but for children who witnessed it, “it’s had effects for decades. There were huge amounts of money sent in, and lots of health care for kids who were down there, but despite that, we have this. We think the PTSD morphed into” long-term issues, Dr. Amsel said.

“We know that one of the reasons people get psychiatric disorders” after trauma “is that they generalize the fear; the message to your brain is that everything is dangerous. You’ve got to intervene there and break the association between the fear system and everything else, so that life is still safe,” he said.

There’s an added element with human violence. “Life may be unsafe” after a natural disaster, “but you know that human beings are good and helpful. With a terrorist attack, you stop trusting people,” he said.

Cognitive behavioral therapy could help, among other approaches. It also might be helpful to teach resilience to schoolchildren, just like biology and algebra, he said.

Cases and controls were evenly split between the sexes. Just over 40% of subjects in both groups were white, followed by Hispanics, Asians, and blacks. The majority of households were middle income.

The next step is to break the results down by age, ethnicity, socioeconomic factors, and support systems. The team will run blood work and heart and lung tests on the subjects to nail down the physical problems reported by witnesses. There are concerns about the lingering effects of the dust plume.

The work is funded by the federal government. Dr. Amsel didn’t have any relevant financial disclosures.

[email protected]

SAN FRANCISCO – Children who witnessed the 9/11 attacks on the World Trade Center are almost fivefold as likely to suffer comorbid physical and psychiatric problems as adults, according to a case-control study presented at the American Psychiatric Association annual meeting.

The investigation included 942 people who, as children under 18 years old, were in school below Canal Street in lower Manhattan when the World Trade Center was attacked. They saw the towers collapse and were evacuated from the area, but did not lose a parent. Now 18-36 years old, they were interviewed in their homes and asked to filled out questionnaires about psychiatric and physical problems. The outcomes were compared with 563 age- and gender-matched controls who were in school in Queens at the time.

In turns out that “it made a huge difference whether you were there or not. Being there had much more impact than hearing about it or watching it on TV,” said lead investigator Lawrence Amsel, MD, an assistant professor of clinical psychiatry at Columbia University in New York.

Adults who witnessed the attacks as children were more than twice as likely to have panic disorder, marijuana use disorder, and separation anxiety, which is uncommon in adults; anxiety disorders were more prevalent, as well.

They also were almost half as likely to be living with a spouse or partner, and half as likely to be living independently. “That kind of goes along with the separation anxiety; these kids were more likely to be afraid of moving away from their family and breaking out into their own lives,” Dr. Amsel said.

Overall, 36% had a psychiatric disorder, and 27% had a physical problem, such as diabetes, asthma, or eczema; 14% had both. Among adults who were in Queens during the attacks, 28% had a psychiatric disorder, and 11% a physical problem; 4% were comorbid.

The increased odds of physical-psychiatric comorbidity among witnesses (adjusted odds ratio, 4.60; 95% confidence interval, 2.75- 7.71; P less than .0001) “was not due simply to an increase in physical conditions,” according to the study team.

“This was a single event,” Dr. Amsel said, but for children who witnessed it, “it’s had effects for decades. There were huge amounts of money sent in, and lots of health care for kids who were down there, but despite that, we have this. We think the PTSD morphed into” long-term issues, Dr. Amsel said.

“We know that one of the reasons people get psychiatric disorders” after trauma “is that they generalize the fear; the message to your brain is that everything is dangerous. You’ve got to intervene there and break the association between the fear system and everything else, so that life is still safe,” he said.

There’s an added element with human violence. “Life may be unsafe” after a natural disaster, “but you know that human beings are good and helpful. With a terrorist attack, you stop trusting people,” he said.

Cognitive behavioral therapy could help, among other approaches. It also might be helpful to teach resilience to schoolchildren, just like biology and algebra, he said.

Cases and controls were evenly split between the sexes. Just over 40% of subjects in both groups were white, followed by Hispanics, Asians, and blacks. The majority of households were middle income.

The next step is to break the results down by age, ethnicity, socioeconomic factors, and support systems. The team will run blood work and heart and lung tests on the subjects to nail down the physical problems reported by witnesses. There are concerns about the lingering effects of the dust plume.

The work is funded by the federal government. Dr. Amsel didn’t have any relevant financial disclosures.

[email protected]

The U.S. measles count for 2019 had its smallest weekly increase in over 2 months last week as the total for the year hit 880 cases, according to the Centers for Disease Control and Prevention.

The U.S. measles count for 2019 had its smallest weekly increase in over 2 months last week as the total for the year hit 880 cases, according to the Centers for Disease Control and Prevention.

The U.S. measles count for 2019 had its smallest weekly increase in over 2 months last week as the total for the year hit 880 cases, according to the Centers for Disease Control and Prevention.

SAN DIEGO – People who were more physically active, including those who did strength training, had significantly reduced risks of cirrhosis-related and liver cancer–related mortality, based on 26 years of prospective data from 113,000 participants in the Nurses Health Study and the Health Professionals Follow-Up Study.

Adults in the highest quintile of physical activity in the study had a 73% lower risk for cirrhosis-related death than did those in the lowest quintile, according to researchers at Massachusetts General Hospital and Harvard Medical School, Boston, who presented the study findings at Digestive Disease Week 2019.

One of the researchers, Tracey Simon, MD, MPH, of Massachusetts General Hospital, Boston, broke down the major take-home messages from the study in this video interview.

For example, vigorous activity was not necessary to improve hepatic health, she said. Walking for 4 hours per week made a big difference.

Dr. Simon has no relevant financial disclosures.

[email protected]

SAN DIEGO – People who were more physically active, including those who did strength training, had significantly reduced risks of cirrhosis-related and liver cancer–related mortality, based on 26 years of prospective data from 113,000 participants in the Nurses Health Study and the Health Professionals Follow-Up Study.

Adults in the highest quintile of physical activity in the study had a 73% lower risk for cirrhosis-related death than did those in the lowest quintile, according to researchers at Massachusetts General Hospital and Harvard Medical School, Boston, who presented the study findings at Digestive Disease Week 2019.

One of the researchers, Tracey Simon, MD, MPH, of Massachusetts General Hospital, Boston, broke down the major take-home messages from the study in this video interview.

For example, vigorous activity was not necessary to improve hepatic health, she said. Walking for 4 hours per week made a big difference.

Dr. Simon has no relevant financial disclosures.

[email protected]

SAN DIEGO – People who were more physically active, including those who did strength training, had significantly reduced risks of cirrhosis-related and liver cancer–related mortality, based on 26 years of prospective data from 113,000 participants in the Nurses Health Study and the Health Professionals Follow-Up Study.

Adults in the highest quintile of physical activity in the study had a 73% lower risk for cirrhosis-related death than did those in the lowest quintile, according to researchers at Massachusetts General Hospital and Harvard Medical School, Boston, who presented the study findings at Digestive Disease Week 2019.

One of the researchers, Tracey Simon, MD, MPH, of Massachusetts General Hospital, Boston, broke down the major take-home messages from the study in this video interview.

For example, vigorous activity was not necessary to improve hepatic health, she said. Walking for 4 hours per week made a big difference.

Dr. Simon has no relevant financial disclosures.

[email protected]

Nine in 10 radiation oncologists report that prior authorization for treatment is either very challenging (42%) or moderately challenging (48%), according to data from a member survey released by the American Society for Radiation Oncology (ASTRO).

Hlib Shabashnyi/Thinkstock

“In 2018, [prior authorization] became the most challenging issue facing radiation oncologists,” Paul Harari, MD, Jack Fowler Professor and chair of oncology at the University of Wisconsin, Madison, and chair of the ASTRO board of directors, said during a press briefing. “Prior authorization is creating multiple obstacles to cancer patient care.”

According to responses from 673 ASTRO members, 31% said seeking prior authorization has caused delays in treatment of 5 or more days, 32% said it causes delays of 4-5 days, and 30% said it causes delays of 1-3 days. Seven percent said the prior authorization requests are resolved within less than a day.

Prior authorization delays forced 32% of respondents to alter treatment plans in more than 10% of their cases, and another 31% said treatment plans were altered in 5%-10% of their cases. For 37% of the respondents, less than 5% of their treatment plans were altered because of delays in the prior authorization process.

Data on initial treatment denials show that few hold up on appeal.

“If there is evidence of large-scale inappropriate utilization or overutilization, then treatment denials should withstand scrutiny on appeal,” Vivek Kavadi, MD, a radiation oncologist with Texas Oncology and vice chair of ASTRO’s Payer Relations Subcommittee, said during the briefing. “However, that is not what we found. This raises serious questions on the justification for the denial in the first place.”

In the survey, 41% of respondents said 76%-100% of denials are overturned, 22% said 51%-75% are overturned, 17% said 26%-50% are overturned, 19% said 0-25% are overturned, and 2% said none of their appeals resulted in a prior authorization denial being overturned.

In addition, 44% of respondents said the peer-to-peer appeals processes are typically not handled by a radiation oncologist on the payer side.

“We very rarely have a case denied following peer-to-peer review or appeal,” Dr. Harari said. “However, the many hours spent by our physician providers and the delays in commencing treatment for these cancer patients can never be recovered.”

To handle the workload generated by the prior authorization process, 63% of those responding to the survey said they have hired staff specifically to handle prior authorization requests.

“In an era of value-based care, where is the value when we are increasing costs without adding clinical benefit?” Dr. Kavadi asked.

Dr. Harari called for legislation to simplify the prior authorization process and make it less burdensome, but individual proposals were not highlighted.

[email protected]

SOURCE: American Society for Radiation Oncology survey.

Nine in 10 radiation oncologists report that prior authorization for treatment is either very challenging (42%) or moderately challenging (48%), according to data from a member survey released by the American Society for Radiation Oncology (ASTRO).

Hlib Shabashnyi/Thinkstock

“In 2018, [prior authorization] became the most challenging issue facing radiation oncologists,” Paul Harari, MD, Jack Fowler Professor and chair of oncology at the University of Wisconsin, Madison, and chair of the ASTRO board of directors, said during a press briefing. “Prior authorization is creating multiple obstacles to cancer patient care.”

According to responses from 673 ASTRO members, 31% said seeking prior authorization has caused delays in treatment of 5 or more days, 32% said it causes delays of 4-5 days, and 30% said it causes delays of 1-3 days. Seven percent said the prior authorization requests are resolved within less than a day.

Prior authorization delays forced 32% of respondents to alter treatment plans in more than 10% of their cases, and another 31% said treatment plans were altered in 5%-10% of their cases. For 37% of the respondents, less than 5% of their treatment plans were altered because of delays in the prior authorization process.

Data on initial treatment denials show that few hold up on appeal.

“If there is evidence of large-scale inappropriate utilization or overutilization, then treatment denials should withstand scrutiny on appeal,” Vivek Kavadi, MD, a radiation oncologist with Texas Oncology and vice chair of ASTRO’s Payer Relations Subcommittee, said during the briefing. “However, that is not what we found. This raises serious questions on the justification for the denial in the first place.”

In the survey, 41% of respondents said 76%-100% of denials are overturned, 22% said 51%-75% are overturned, 17% said 26%-50% are overturned, 19% said 0-25% are overturned, and 2% said none of their appeals resulted in a prior authorization denial being overturned.

In addition, 44% of respondents said the peer-to-peer appeals processes are typically not handled by a radiation oncologist on the payer side.

“We very rarely have a case denied following peer-to-peer review or appeal,” Dr. Harari said. “However, the many hours spent by our physician providers and the delays in commencing treatment for these cancer patients can never be recovered.”

To handle the workload generated by the prior authorization process, 63% of those responding to the survey said they have hired staff specifically to handle prior authorization requests.

“In an era of value-based care, where is the value when we are increasing costs without adding clinical benefit?” Dr. Kavadi asked.

Dr. Harari called for legislation to simplify the prior authorization process and make it less burdensome, but individual proposals were not highlighted.

[email protected]

SOURCE: American Society for Radiation Oncology survey.

Nine in 10 radiation oncologists report that prior authorization for treatment is either very challenging (42%) or moderately challenging (48%), according to data from a member survey released by the American Society for Radiation Oncology (ASTRO).

Hlib Shabashnyi/Thinkstock

“In 2018, [prior authorization] became the most challenging issue facing radiation oncologists,” Paul Harari, MD, Jack Fowler Professor and chair of oncology at the University of Wisconsin, Madison, and chair of the ASTRO board of directors, said during a press briefing. “Prior authorization is creating multiple obstacles to cancer patient care.”

According to responses from 673 ASTRO members, 31% said seeking prior authorization has caused delays in treatment of 5 or more days, 32% said it causes delays of 4-5 days, and 30% said it causes delays of 1-3 days. Seven percent said the prior authorization requests are resolved within less than a day.

Prior authorization delays forced 32% of respondents to alter treatment plans in more than 10% of their cases, and another 31% said treatment plans were altered in 5%-10% of their cases. For 37% of the respondents, less than 5% of their treatment plans were altered because of delays in the prior authorization process.

Data on initial treatment denials show that few hold up on appeal.

“If there is evidence of large-scale inappropriate utilization or overutilization, then treatment denials should withstand scrutiny on appeal,” Vivek Kavadi, MD, a radiation oncologist with Texas Oncology and vice chair of ASTRO’s Payer Relations Subcommittee, said during the briefing. “However, that is not what we found. This raises serious questions on the justification for the denial in the first place.”

In the survey, 41% of respondents said 76%-100% of denials are overturned, 22% said 51%-75% are overturned, 17% said 26%-50% are overturned, 19% said 0-25% are overturned, and 2% said none of their appeals resulted in a prior authorization denial being overturned.

In addition, 44% of respondents said the peer-to-peer appeals processes are typically not handled by a radiation oncologist on the payer side.

“We very rarely have a case denied following peer-to-peer review or appeal,” Dr. Harari said. “However, the many hours spent by our physician providers and the delays in commencing treatment for these cancer patients can never be recovered.”

To handle the workload generated by the prior authorization process, 63% of those responding to the survey said they have hired staff specifically to handle prior authorization requests.

“In an era of value-based care, where is the value when we are increasing costs without adding clinical benefit?” Dr. Kavadi asked.

Dr. Harari called for legislation to simplify the prior authorization process and make it less burdensome, but individual proposals were not highlighted.

[email protected]

SOURCE: American Society for Radiation Oncology survey.

The Diagnosis: Kaposi Sarcoma

A 4-mm punch biopsy from the border of an ulcerated nodular lesion on the hard palate demonstrated diffusely distributed spindle cells, cleftlike microvascularity with extravasated erythrocytes, and widespread human herpesvirus 8 immunoreactivity on histopathology (Figure 1). Serologic tests were positive for human immunodeficiency virus (HIV) infection; HIV RNA was 14,584 IU/mL and the CD4 count was 254/mm³. The patient was diagnosed with Kaposi sarcoma (KS) and referred to the infectious disease department for initiation of antiviral therapy. Marked regression was detected after 6 months of highly active antiretroviral therapy (HAART) without any additional treatment (Figure 2).  

Kaposi sarcoma is a human herpesvirus 8-associated angioproliferative disorder with low-grade malignant potential. There are 4 well-known clinical types: classic, endemic, iatrogenic, and AIDS associated.¹ Involvement of the oral cavity may be seen in all types but mostly is associated with the AIDS-associated type, which also could be a signal for undiagnosed asymptomatic HIV infection.² Oral KS most often affects the hard and soft palate, gingiva, and dorsal tongue, with plaques or tumors ranging from nonpigmented to brownish red or violaceous. AIDS-associated KS is known to be related to cytokine expression, which is induced by HIV infection causing immune dysregulation by altering the expression of cytokines, including IL-1, tumor necrosis factor α, and IL-6.¹ An in vitro study showed that cytokines secrete a number of angiogenic growth factors that, along with HIV proteins, induce and proliferate cells to become sarcoma cells. Integrins and the apoptosis process also are important in proliferation and neovascularization of KS tumor cells.³  

Bacillary angiomatosis (BA) is a rare manifestation of infection caused by Bartonella species, which leads to vasoproliferative lesions of the skin and other organs. Bacillary angiomatosis affects individuals with advanced HIV or other immunocompromised individuals and may clinically mimic KS, which is similarly characterized by red-purple papules, nodules, or plaques. Differentiating BA from KS largely depends on histopathologic examination, with BA demonstrating protuberant endothelial cells surrounded by clumps of bacilli that are visible on Warthin-Starry silver stain. 

Lymphangioma is a benign hamartomatous hyperplasia of the lymphatic vessels. The majority of lymphangiomas are superficial, but a few may extend deeply into the connective tissue. Intraoral lymphangiomas occur more frequently on the dorsum of the tongue, followed by the palate, buccal mucosa, gingiva, and lips. They may be differentiated with their soft quality, pebblelike surface, and translucent vesicles. 

Malignant tumors of the oral cavity are rare, representing only 5% of tumors occurring in the body.⁴ Among malignant tumors of the oral cavity, squamous cell carcinomas are the most frequent type (90%-98%), and lymphomas and melanoma are the most outstanding among the remaining 2% to 10%. Both for lymphoma and mucosal melanoma, the most common sites of involvement are the soft tissues of the oral cavity, palatal mucosa, gingiva, tongue, cheeks, floor of the mouth, and lips.⁴ Although mucosal melanoma lesions usually are characterized by pigmented and ulcerated lesions, amelanotic variants also should be kept in mind. Histopathologic examination is mandatory for diagnosis.   

Intralesional chemotherapy with vinblastine or bleomycin, radiotherapy, electrochemotherapy, systemic antiretroviral therapy (ie, HAART), and chemotherapy with daunorubicin and pegylated liposomal doxorubicin are the main treatment options.^5,6 The immune system activator role of HAART leads to an increased CD4 count and reduces HIV proteins, which helps induction of the proliferation and neovascularization of KS tumor cells.³ This effect may help resolution of KS with localized involvement and allows physicians to utilize HAART without any other additional local and systemic chemotherapy treatment. 

The Diagnosis: Kaposi Sarcoma

A 4-mm punch biopsy from the border of an ulcerated nodular lesion on the hard palate demonstrated diffusely distributed spindle cells, cleftlike microvascularity with extravasated erythrocytes, and widespread human herpesvirus 8 immunoreactivity on histopathology (Figure 1). Serologic tests were positive for human immunodeficiency virus (HIV) infection; HIV RNA was 14,584 IU/mL and the CD4 count was 254/mm³. The patient was diagnosed with Kaposi sarcoma (KS) and referred to the infectious disease department for initiation of antiviral therapy. Marked regression was detected after 6 months of highly active antiretroviral therapy (HAART) without any additional treatment (Figure 2).  

Kaposi sarcoma is a human herpesvirus 8-associated angioproliferative disorder with low-grade malignant potential. There are 4 well-known clinical types: classic, endemic, iatrogenic, and AIDS associated.¹ Involvement of the oral cavity may be seen in all types but mostly is associated with the AIDS-associated type, which also could be a signal for undiagnosed asymptomatic HIV infection.² Oral KS most often affects the hard and soft palate, gingiva, and dorsal tongue, with plaques or tumors ranging from nonpigmented to brownish red or violaceous. AIDS-associated KS is known to be related to cytokine expression, which is induced by HIV infection causing immune dysregulation by altering the expression of cytokines, including IL-1, tumor necrosis factor α, and IL-6.¹ An in vitro study showed that cytokines secrete a number of angiogenic growth factors that, along with HIV proteins, induce and proliferate cells to become sarcoma cells. Integrins and the apoptosis process also are important in proliferation and neovascularization of KS tumor cells.³  

Bacillary angiomatosis (BA) is a rare manifestation of infection caused by Bartonella species, which leads to vasoproliferative lesions of the skin and other organs. Bacillary angiomatosis affects individuals with advanced HIV or other immunocompromised individuals and may clinically mimic KS, which is similarly characterized by red-purple papules, nodules, or plaques. Differentiating BA from KS largely depends on histopathologic examination, with BA demonstrating protuberant endothelial cells surrounded by clumps of bacilli that are visible on Warthin-Starry silver stain. 

Lymphangioma is a benign hamartomatous hyperplasia of the lymphatic vessels. The majority of lymphangiomas are superficial, but a few may extend deeply into the connective tissue. Intraoral lymphangiomas occur more frequently on the dorsum of the tongue, followed by the palate, buccal mucosa, gingiva, and lips. They may be differentiated with their soft quality, pebblelike surface, and translucent vesicles. 

Malignant tumors of the oral cavity are rare, representing only 5% of tumors occurring in the body.⁴ Among malignant tumors of the oral cavity, squamous cell carcinomas are the most frequent type (90%-98%), and lymphomas and melanoma are the most outstanding among the remaining 2% to 10%. Both for lymphoma and mucosal melanoma, the most common sites of involvement are the soft tissues of the oral cavity, palatal mucosa, gingiva, tongue, cheeks, floor of the mouth, and lips.⁴ Although mucosal melanoma lesions usually are characterized by pigmented and ulcerated lesions, amelanotic variants also should be kept in mind. Histopathologic examination is mandatory for diagnosis.   

Intralesional chemotherapy with vinblastine or bleomycin, radiotherapy, electrochemotherapy, systemic antiretroviral therapy (ie, HAART), and chemotherapy with daunorubicin and pegylated liposomal doxorubicin are the main treatment options.^5,6 The immune system activator role of HAART leads to an increased CD4 count and reduces HIV proteins, which helps induction of the proliferation and neovascularization of KS tumor cells.³ This effect may help resolution of KS with localized involvement and allows physicians to utilize HAART without any other additional local and systemic chemotherapy treatment. 

The Diagnosis: Kaposi Sarcoma

A 4-mm punch biopsy from the border of an ulcerated nodular lesion on the hard palate demonstrated diffusely distributed spindle cells, cleftlike microvascularity with extravasated erythrocytes, and widespread human herpesvirus 8 immunoreactivity on histopathology (Figure 1). Serologic tests were positive for human immunodeficiency virus (HIV) infection; HIV RNA was 14,584 IU/mL and the CD4 count was 254/mm³. The patient was diagnosed with Kaposi sarcoma (KS) and referred to the infectious disease department for initiation of antiviral therapy. Marked regression was detected after 6 months of highly active antiretroviral therapy (HAART) without any additional treatment (Figure 2).  

Kaposi sarcoma is a human herpesvirus 8-associated angioproliferative disorder with low-grade malignant potential. There are 4 well-known clinical types: classic, endemic, iatrogenic, and AIDS associated.¹ Involvement of the oral cavity may be seen in all types but mostly is associated with the AIDS-associated type, which also could be a signal for undiagnosed asymptomatic HIV infection.² Oral KS most often affects the hard and soft palate, gingiva, and dorsal tongue, with plaques or tumors ranging from nonpigmented to brownish red or violaceous. AIDS-associated KS is known to be related to cytokine expression, which is induced by HIV infection causing immune dysregulation by altering the expression of cytokines, including IL-1, tumor necrosis factor α, and IL-6.¹ An in vitro study showed that cytokines secrete a number of angiogenic growth factors that, along with HIV proteins, induce and proliferate cells to become sarcoma cells. Integrins and the apoptosis process also are important in proliferation and neovascularization of KS tumor cells.³  

Bacillary angiomatosis (BA) is a rare manifestation of infection caused by Bartonella species, which leads to vasoproliferative lesions of the skin and other organs. Bacillary angiomatosis affects individuals with advanced HIV or other immunocompromised individuals and may clinically mimic KS, which is similarly characterized by red-purple papules, nodules, or plaques. Differentiating BA from KS largely depends on histopathologic examination, with BA demonstrating protuberant endothelial cells surrounded by clumps of bacilli that are visible on Warthin-Starry silver stain. 

Lymphangioma is a benign hamartomatous hyperplasia of the lymphatic vessels. The majority of lymphangiomas are superficial, but a few may extend deeply into the connective tissue. Intraoral lymphangiomas occur more frequently on the dorsum of the tongue, followed by the palate, buccal mucosa, gingiva, and lips. They may be differentiated with their soft quality, pebblelike surface, and translucent vesicles. 

Malignant tumors of the oral cavity are rare, representing only 5% of tumors occurring in the body.⁴ Among malignant tumors of the oral cavity, squamous cell carcinomas are the most frequent type (90%-98%), and lymphomas and melanoma are the most outstanding among the remaining 2% to 10%. Both for lymphoma and mucosal melanoma, the most common sites of involvement are the soft tissues of the oral cavity, palatal mucosa, gingiva, tongue, cheeks, floor of the mouth, and lips.⁴ Although mucosal melanoma lesions usually are characterized by pigmented and ulcerated lesions, amelanotic variants also should be kept in mind. Histopathologic examination is mandatory for diagnosis.   

Intralesional chemotherapy with vinblastine or bleomycin, radiotherapy, electrochemotherapy, systemic antiretroviral therapy (ie, HAART), and chemotherapy with daunorubicin and pegylated liposomal doxorubicin are the main treatment options.^5,6 The immune system activator role of HAART leads to an increased CD4 count and reduces HIV proteins, which helps induction of the proliferation and neovascularization of KS tumor cells.³ This effect may help resolution of KS with localized involvement and allows physicians to utilize HAART without any other additional local and systemic chemotherapy treatment. 

TORONTO – As Ontario moved toward bundled payments for services related to orthopedic surgeries for osteoarthritis, procedural volume climbed, average hospital length of stay dropped, and the 30-day postdischarge readmission rate declined modestly. However, emergency department visits shot up by 62%.

Bruce Jancin/MDedge News

And therein lies a key lesson for health policy makers who have embraced bundled payments to reduce rising health care costs, Mayilee Canizares, PhD, observed at the OARSI 2019 World Congress.

In Ontario, with patients discharged sooner and directly to home, there was the negative impact of increased emergency department visits after surgery, Dr. Canizares, of the University Health Network in Toronto, said at OARSI 2019 World Congress, sponsored by the Osteoarthritis Research Society International. “Our findings highlight the importance of coordinating the appropriate support services as well as the need to continue assessing the optimal discharge care plan for osteoarthritis patients undergoing surgery.”

Dr. Canizares’ study of the Ontario-wide experience with orthopedic surgery for osteoarthritis during 2004-2016 received the OARSI 2019 award for the meeting’s top-rated study in clinical epidemiology/health services research.

Using administrative data from Canada’s national health care system, Dr. Canizares and her coinvestigators found that the number of individuals undergoing elective orthopedic surgery for osteoarthritis ballooned from 22,700 in 2004 to 41,900 in 2016, representing an increase from 246 to 381 procedures per 100,000 people. During this time, the mean length of stay declined from about 5 days to just under 3 days, the 30-day readmission rate dropped from 4.2% to 3.4%, and the rate of emergency department visits within 30 days post discharge rose steadily from 8.7% in 2004 to 14.1% in 2016.

Roughly half of the operations were total knee replacements and one-third were hip replacements. The profile of patients undergoing surgery changed little over the course of the 12-year study with the exception that in more recent years patients presented with more comorbidities: Indeed, three or more comorbid conditions were present in 2.9% of the surgical patients in 2004 compared to 4.2% in 2016.

In multivariate logistic regression analyses, patient characteristics didn’t explain the change over time in early readmission or unplanned emergency department visit rates. However, discharge disposition did: By 2014, more patients were being discharged home, and in nearly half of cases that was being done without support.

Dr. Canizares reported having no financial conflicts regarding her study, funded by the Toronto General and Western Hospital Foundation.

[email protected]

SOURCE: Canizares M. OARSI, Abstract 16.

TORONTO – As Ontario moved toward bundled payments for services related to orthopedic surgeries for osteoarthritis, procedural volume climbed, average hospital length of stay dropped, and the 30-day postdischarge readmission rate declined modestly. However, emergency department visits shot up by 62%.

Bruce Jancin/MDedge News

And therein lies a key lesson for health policy makers who have embraced bundled payments to reduce rising health care costs, Mayilee Canizares, PhD, observed at the OARSI 2019 World Congress.

In Ontario, with patients discharged sooner and directly to home, there was the negative impact of increased emergency department visits after surgery, Dr. Canizares, of the University Health Network in Toronto, said at OARSI 2019 World Congress, sponsored by the Osteoarthritis Research Society International. “Our findings highlight the importance of coordinating the appropriate support services as well as the need to continue assessing the optimal discharge care plan for osteoarthritis patients undergoing surgery.”

Dr. Canizares’ study of the Ontario-wide experience with orthopedic surgery for osteoarthritis during 2004-2016 received the OARSI 2019 award for the meeting’s top-rated study in clinical epidemiology/health services research.

Using administrative data from Canada’s national health care system, Dr. Canizares and her coinvestigators found that the number of individuals undergoing elective orthopedic surgery for osteoarthritis ballooned from 22,700 in 2004 to 41,900 in 2016, representing an increase from 246 to 381 procedures per 100,000 people. During this time, the mean length of stay declined from about 5 days to just under 3 days, the 30-day readmission rate dropped from 4.2% to 3.4%, and the rate of emergency department visits within 30 days post discharge rose steadily from 8.7% in 2004 to 14.1% in 2016.

Roughly half of the operations were total knee replacements and one-third were hip replacements. The profile of patients undergoing surgery changed little over the course of the 12-year study with the exception that in more recent years patients presented with more comorbidities: Indeed, three or more comorbid conditions were present in 2.9% of the surgical patients in 2004 compared to 4.2% in 2016.

In multivariate logistic regression analyses, patient characteristics didn’t explain the change over time in early readmission or unplanned emergency department visit rates. However, discharge disposition did: By 2014, more patients were being discharged home, and in nearly half of cases that was being done without support.

Dr. Canizares reported having no financial conflicts regarding her study, funded by the Toronto General and Western Hospital Foundation.

[email protected]

SOURCE: Canizares M. OARSI, Abstract 16.

TORONTO – As Ontario moved toward bundled payments for services related to orthopedic surgeries for osteoarthritis, procedural volume climbed, average hospital length of stay dropped, and the 30-day postdischarge readmission rate declined modestly. However, emergency department visits shot up by 62%.

Bruce Jancin/MDedge News

And therein lies a key lesson for health policy makers who have embraced bundled payments to reduce rising health care costs, Mayilee Canizares, PhD, observed at the OARSI 2019 World Congress.

In Ontario, with patients discharged sooner and directly to home, there was the negative impact of increased emergency department visits after surgery, Dr. Canizares, of the University Health Network in Toronto, said at OARSI 2019 World Congress, sponsored by the Osteoarthritis Research Society International. “Our findings highlight the importance of coordinating the appropriate support services as well as the need to continue assessing the optimal discharge care plan for osteoarthritis patients undergoing surgery.”

Dr. Canizares’ study of the Ontario-wide experience with orthopedic surgery for osteoarthritis during 2004-2016 received the OARSI 2019 award for the meeting’s top-rated study in clinical epidemiology/health services research.

Using administrative data from Canada’s national health care system, Dr. Canizares and her coinvestigators found that the number of individuals undergoing elective orthopedic surgery for osteoarthritis ballooned from 22,700 in 2004 to 41,900 in 2016, representing an increase from 246 to 381 procedures per 100,000 people. During this time, the mean length of stay declined from about 5 days to just under 3 days, the 30-day readmission rate dropped from 4.2% to 3.4%, and the rate of emergency department visits within 30 days post discharge rose steadily from 8.7% in 2004 to 14.1% in 2016.

Roughly half of the operations were total knee replacements and one-third were hip replacements. The profile of patients undergoing surgery changed little over the course of the 12-year study with the exception that in more recent years patients presented with more comorbidities: Indeed, three or more comorbid conditions were present in 2.9% of the surgical patients in 2004 compared to 4.2% in 2016.

In multivariate logistic regression analyses, patient characteristics didn’t explain the change over time in early readmission or unplanned emergency department visit rates. However, discharge disposition did: By 2014, more patients were being discharged home, and in nearly half of cases that was being done without support.

Dr. Canizares reported having no financial conflicts regarding her study, funded by the Toronto General and Western Hospital Foundation.

[email protected]

SOURCE: Canizares M. OARSI, Abstract 16.