New treatment recommendations, released by a panel of nine experts, offer consensus advice on the use of immune tolerance induction (ITI) therapy in patients with hemophilia A with inhibitors.

The recommendations from the Future of Immunotolerance Treatment (FIT) group were authored by a nine-member committee with expertise in the treatment of hemophilia. The authors attended three meetings from 2017-2018 to form a consensus on the use of nonfactor therapies with current inhibitor management strategies.

“The treatment of hemophilia A has evolved and a number of molecules that potentially can be used in the setting of patients with inhibitors have been developed, or are in various phases of development,” wrote Manuel Carcao, MD, of the University of Toronto and colleagues. The report is published in Haemophilia.

The current body of literature is lacking high-quality evidence on the concomitant use of nonfactor treatments, such as emicizumab, and current inhibitor therapies. The recommendations included the panel’s consensus opinions on treatment of inhibitors, with and without the use of nonreplacement therapies. The concurrent use of factor VIII replacement therapy and emicizumab could inhibit bleeding with lower dose immunotolerance strategies, according to the recommendations.

The group hypothesized that increased uptake of lower dose and lower frequency factor VIII ITI treatment strategies could reduce the likelihood of requiring central venous access while retaining a high probability of treatment success.

“In our new algorithm, we have indicated that one option might be to start patients on low-dose ITI with emicizumab regardless of their historical peak inhibitor titre. Patients could then escalate their ITI regimen should their response to low-dose ITI be deemed insufficient,” they wrote.

The experts provided a novel treatment algorithm for immune tolerance induction without emicizumab in addition to a new theoretical strategy with emicizumab.

Other recommendations included that patients with inhibitors should be offered at least one attempt at ITI and that monthly monitoring should be done and ITI dose and frequency should be adjusted based on changes in bleeding phenotype and inhibitor titer.

The authors acknowledged a current limitation is the lack of published evidence pertaining to the concurrent use of emicizumab and factor VIII replacement therapy.

“The FIT group sees the need for properly conducted prospective studies to evaluate the impact of adding emicizumab, and in the future, other nonfactor therapies, into the management of patients with inhibitors,” the experts wrote.

The manuscript was supported by Grifols. The authors reported financial disclosures related to Grifols and other companies.

[email protected]

SOURCE: Carcao M et al. Haemophilia. 2019 Apr 29. doi: 10.1111/hae.13762.

New treatment recommendations, released by a panel of nine experts, offer consensus advice on the use of immune tolerance induction (ITI) therapy in patients with hemophilia A with inhibitors.

The recommendations from the Future of Immunotolerance Treatment (FIT) group were authored by a nine-member committee with expertise in the treatment of hemophilia. The authors attended three meetings from 2017-2018 to form a consensus on the use of nonfactor therapies with current inhibitor management strategies.

“The treatment of hemophilia A has evolved and a number of molecules that potentially can be used in the setting of patients with inhibitors have been developed, or are in various phases of development,” wrote Manuel Carcao, MD, of the University of Toronto and colleagues. The report is published in Haemophilia.

The current body of literature is lacking high-quality evidence on the concomitant use of nonfactor treatments, such as emicizumab, and current inhibitor therapies. The recommendations included the panel’s consensus opinions on treatment of inhibitors, with and without the use of nonreplacement therapies. The concurrent use of factor VIII replacement therapy and emicizumab could inhibit bleeding with lower dose immunotolerance strategies, according to the recommendations.

The group hypothesized that increased uptake of lower dose and lower frequency factor VIII ITI treatment strategies could reduce the likelihood of requiring central venous access while retaining a high probability of treatment success.

“In our new algorithm, we have indicated that one option might be to start patients on low-dose ITI with emicizumab regardless of their historical peak inhibitor titre. Patients could then escalate their ITI regimen should their response to low-dose ITI be deemed insufficient,” they wrote.

The experts provided a novel treatment algorithm for immune tolerance induction without emicizumab in addition to a new theoretical strategy with emicizumab.

Other recommendations included that patients with inhibitors should be offered at least one attempt at ITI and that monthly monitoring should be done and ITI dose and frequency should be adjusted based on changes in bleeding phenotype and inhibitor titer.

The authors acknowledged a current limitation is the lack of published evidence pertaining to the concurrent use of emicizumab and factor VIII replacement therapy.

“The FIT group sees the need for properly conducted prospective studies to evaluate the impact of adding emicizumab, and in the future, other nonfactor therapies, into the management of patients with inhibitors,” the experts wrote.

The manuscript was supported by Grifols. The authors reported financial disclosures related to Grifols and other companies.

[email protected]

SOURCE: Carcao M et al. Haemophilia. 2019 Apr 29. doi: 10.1111/hae.13762.

New treatment recommendations, released by a panel of nine experts, offer consensus advice on the use of immune tolerance induction (ITI) therapy in patients with hemophilia A with inhibitors.

The recommendations from the Future of Immunotolerance Treatment (FIT) group were authored by a nine-member committee with expertise in the treatment of hemophilia. The authors attended three meetings from 2017-2018 to form a consensus on the use of nonfactor therapies with current inhibitor management strategies.

“The treatment of hemophilia A has evolved and a number of molecules that potentially can be used in the setting of patients with inhibitors have been developed, or are in various phases of development,” wrote Manuel Carcao, MD, of the University of Toronto and colleagues. The report is published in Haemophilia.

The current body of literature is lacking high-quality evidence on the concomitant use of nonfactor treatments, such as emicizumab, and current inhibitor therapies. The recommendations included the panel’s consensus opinions on treatment of inhibitors, with and without the use of nonreplacement therapies. The concurrent use of factor VIII replacement therapy and emicizumab could inhibit bleeding with lower dose immunotolerance strategies, according to the recommendations.

The group hypothesized that increased uptake of lower dose and lower frequency factor VIII ITI treatment strategies could reduce the likelihood of requiring central venous access while retaining a high probability of treatment success.

“In our new algorithm, we have indicated that one option might be to start patients on low-dose ITI with emicizumab regardless of their historical peak inhibitor titre. Patients could then escalate their ITI regimen should their response to low-dose ITI be deemed insufficient,” they wrote.

The experts provided a novel treatment algorithm for immune tolerance induction without emicizumab in addition to a new theoretical strategy with emicizumab.

Other recommendations included that patients with inhibitors should be offered at least one attempt at ITI and that monthly monitoring should be done and ITI dose and frequency should be adjusted based on changes in bleeding phenotype and inhibitor titer.

The authors acknowledged a current limitation is the lack of published evidence pertaining to the concurrent use of emicizumab and factor VIII replacement therapy.

“The FIT group sees the need for properly conducted prospective studies to evaluate the impact of adding emicizumab, and in the future, other nonfactor therapies, into the management of patients with inhibitors,” the experts wrote.

The manuscript was supported by Grifols. The authors reported financial disclosures related to Grifols and other companies.

[email protected]

SOURCE: Carcao M et al. Haemophilia. 2019 Apr 29. doi: 10.1111/hae.13762.

BALTIMORE – Neural networks are the building blocks of machine learning and artificial intelligence, and researchers from the University of Minnesota have identified a panel of “simple, readily known” preoperative patient factors that they fed into an artificial neural network model that can be predictive of 30-day outcomes after laparoscopic sleeve gastrectomy, one of the researchers reported at the annual meeting of the Society of American Gastrointestinal and Endoscopic Surgeons.

“The biggest limitation to using neural networks clinically is the fact that they’re algorithmic complex,” said Eric S. Wise, MD, of the University of Minnesota, Minneapolis, in presenting the research. “There is an underlying algorithm that’s developed, but it’s very difficult to understand.” He called it “a black box problem.”

Nonetheless, the researchers drew upon 101,721 laparoscopic sleeve gastrectomy cases from the 2016 Metabolic and Bariatric Surgery Accreditation and Quality Improvement Program national database to extract factors that were associated with postoperative complications. “More pertinently, we wanted to optimize predictability of a panel of readily obtainable, easily qualifiable preoperative factors and maximize the variants that are contained within those variables to predict the outcome of 30-day morbidity and mortality,” Dr. Wise said.

Essentially, neural networks recognize patterns through a machine-learning process in a manner modeled on the human brain. As Dr. Wise explained, they first emerged in the 1960s to simulate the human brain’s psychological-neurologic systems.

Through bivariate and multivariate analyses, the research identified eight preoperative variables strongly associated with the 30-day endpoints. After univariate analysis, seven of those variables were statistically significant: older age (P = .03), nonwhite race, higher initial body mass index, severe hypertension, history of diabetes, nonindependent functional status, and previous foregut/bariatric surgery (all P less than .001). “Gender was the only factor that was not predictive,” Dr. Wise said.

The factors held up under logistic regression modeling. “We were able to use a traditional logistic regression model that came up with a reasonable area under the curve of 0.572,” he said. Using artificial neural network analysis, the training set, which comprised 80% of patients, was more accurate than logistic regression, with an area under the curve of 0.582.

One limitation was that this was a “small study,” Dr. Wise said, influenced by selection bias inherent in any retrospective data selection. Other major factors that may exist were not considered.

However, he noted, “in the past we’ve had some success translating neural networks into something that’s clinically useful.” His group at Vanderbilt University published a report of artificial neural network modeling to identify five factors predictive of weight loss after Roux-en-Y gastric bypass 2 years ago (Surg Endosc. 2016;30:480-8). “There are ways to translate neural networks clinically,” Dr. Wise said.

Dr. Wise had no financial relationships to disclose.

SOURCE: Wise ES et al. SAGES 2019, Abstract S053.

BALTIMORE – Neural networks are the building blocks of machine learning and artificial intelligence, and researchers from the University of Minnesota have identified a panel of “simple, readily known” preoperative patient factors that they fed into an artificial neural network model that can be predictive of 30-day outcomes after laparoscopic sleeve gastrectomy, one of the researchers reported at the annual meeting of the Society of American Gastrointestinal and Endoscopic Surgeons.

“The biggest limitation to using neural networks clinically is the fact that they’re algorithmic complex,” said Eric S. Wise, MD, of the University of Minnesota, Minneapolis, in presenting the research. “There is an underlying algorithm that’s developed, but it’s very difficult to understand.” He called it “a black box problem.”

Nonetheless, the researchers drew upon 101,721 laparoscopic sleeve gastrectomy cases from the 2016 Metabolic and Bariatric Surgery Accreditation and Quality Improvement Program national database to extract factors that were associated with postoperative complications. “More pertinently, we wanted to optimize predictability of a panel of readily obtainable, easily qualifiable preoperative factors and maximize the variants that are contained within those variables to predict the outcome of 30-day morbidity and mortality,” Dr. Wise said.

Essentially, neural networks recognize patterns through a machine-learning process in a manner modeled on the human brain. As Dr. Wise explained, they first emerged in the 1960s to simulate the human brain’s psychological-neurologic systems.

Through bivariate and multivariate analyses, the research identified eight preoperative variables strongly associated with the 30-day endpoints. After univariate analysis, seven of those variables were statistically significant: older age (P = .03), nonwhite race, higher initial body mass index, severe hypertension, history of diabetes, nonindependent functional status, and previous foregut/bariatric surgery (all P less than .001). “Gender was the only factor that was not predictive,” Dr. Wise said.

The factors held up under logistic regression modeling. “We were able to use a traditional logistic regression model that came up with a reasonable area under the curve of 0.572,” he said. Using artificial neural network analysis, the training set, which comprised 80% of patients, was more accurate than logistic regression, with an area under the curve of 0.582.

One limitation was that this was a “small study,” Dr. Wise said, influenced by selection bias inherent in any retrospective data selection. Other major factors that may exist were not considered.

However, he noted, “in the past we’ve had some success translating neural networks into something that’s clinically useful.” His group at Vanderbilt University published a report of artificial neural network modeling to identify five factors predictive of weight loss after Roux-en-Y gastric bypass 2 years ago (Surg Endosc. 2016;30:480-8). “There are ways to translate neural networks clinically,” Dr. Wise said.

Dr. Wise had no financial relationships to disclose.

SOURCE: Wise ES et al. SAGES 2019, Abstract S053.

BALTIMORE – Neural networks are the building blocks of machine learning and artificial intelligence, and researchers from the University of Minnesota have identified a panel of “simple, readily known” preoperative patient factors that they fed into an artificial neural network model that can be predictive of 30-day outcomes after laparoscopic sleeve gastrectomy, one of the researchers reported at the annual meeting of the Society of American Gastrointestinal and Endoscopic Surgeons.

“The biggest limitation to using neural networks clinically is the fact that they’re algorithmic complex,” said Eric S. Wise, MD, of the University of Minnesota, Minneapolis, in presenting the research. “There is an underlying algorithm that’s developed, but it’s very difficult to understand.” He called it “a black box problem.”

Nonetheless, the researchers drew upon 101,721 laparoscopic sleeve gastrectomy cases from the 2016 Metabolic and Bariatric Surgery Accreditation and Quality Improvement Program national database to extract factors that were associated with postoperative complications. “More pertinently, we wanted to optimize predictability of a panel of readily obtainable, easily qualifiable preoperative factors and maximize the variants that are contained within those variables to predict the outcome of 30-day morbidity and mortality,” Dr. Wise said.

Essentially, neural networks recognize patterns through a machine-learning process in a manner modeled on the human brain. As Dr. Wise explained, they first emerged in the 1960s to simulate the human brain’s psychological-neurologic systems.

Through bivariate and multivariate analyses, the research identified eight preoperative variables strongly associated with the 30-day endpoints. After univariate analysis, seven of those variables were statistically significant: older age (P = .03), nonwhite race, higher initial body mass index, severe hypertension, history of diabetes, nonindependent functional status, and previous foregut/bariatric surgery (all P less than .001). “Gender was the only factor that was not predictive,” Dr. Wise said.

The factors held up under logistic regression modeling. “We were able to use a traditional logistic regression model that came up with a reasonable area under the curve of 0.572,” he said. Using artificial neural network analysis, the training set, which comprised 80% of patients, was more accurate than logistic regression, with an area under the curve of 0.582.

One limitation was that this was a “small study,” Dr. Wise said, influenced by selection bias inherent in any retrospective data selection. Other major factors that may exist were not considered.

However, he noted, “in the past we’ve had some success translating neural networks into something that’s clinically useful.” His group at Vanderbilt University published a report of artificial neural network modeling to identify five factors predictive of weight loss after Roux-en-Y gastric bypass 2 years ago (Surg Endosc. 2016;30:480-8). “There are ways to translate neural networks clinically,” Dr. Wise said.

Dr. Wise had no financial relationships to disclose.

SOURCE: Wise ES et al. SAGES 2019, Abstract S053.

The risk of HIV transmission between serodiscordant male gay couples is effectively zero if the viral load is completely suppressed with antiretroviral therapy, according to a new paper published in the Lancet.

NIAID

The prospective observational PARTNER2 study (Lancet 2019 May 2. doi: 10.1016/S0140-6736[19]304018-0) followed 782 serodiscordant gay couples from 14 European countries, where the HIV-positive partner had to be virally suppressed to below 200 copies of HIV-1 RNA per milliliter, and the couple was engaging in condomless sex without using pre- or postexposure prophylaxis.

After a median follow-up of 2 years, there was not a single case of HIV transmission between couples, representing a transmission rate of zero. The study did record 15 new HIV infections during follow-up but these were all phylogenetically linked to sources other than the HIV-positive partner.

The HIV-positive partners had been on antiretroviral therapy for a median of 4.3 years – most on regimens of three or more drugs – with high levels of adherence. During the follow-up period, 37 HIV-positive partners (5%) reported missing their antiretroviral therapy for more than 4 consecutive days.

“Our results give equivalence of evidence for gay men as for heterosexual couples and indicate that the risk of HIV transmission when HIV viral load is suppressed is effectively zero for both anal and vaginal sex,” wrote Dr. Alison J. Rodger of the Institute for Global Health at University College London, and coauthors. “These findings emphasize the importance of regular monitoring to ensure HIV viral load remains suppressed and supporting HIV-positive people with long-term adherence.”

Around one-quarter of the HIV-negative men and 27% of the HIV-positive men reported a sexually-transmitted infection during follow-up; the most common infections were syphilis, gonorrhea, and chlamydia.

The study noted six additional cases of seroconversion of HIV-negative partners. However, these occurred outside the eligible couple-years of the follow-up period. They were ineligible due to no questionnaire about sexual behavior having been completed by either partner in the couple, a lack of condomless sex between the couple, use of postexposure prophylaxis, or a lack of viral load measurement for the HIV-positive partner in the past year.

The authors did note that the study population was predominantly white and with a median age of 38 years, while most HIV transmission occurs in young people aged under 25 years.

“The results from the PARTNER studies support wider dissemination of the message of the U=U [Undetectable equals Untransmittable] campaign that risk of transmission of HIV in the context of virally suppressive ART is zero,” they wrote.

The study was supported by the National Institute for Health Research, the British HIV Association, the Danish National Research Foundation, ViiV Healthcare, Gilead Sciences, Augustinus Fonden, and A P Møller Fonden. Fourteen authors declared grants, personal fees and other support from the pharmaceutical sector.

SOURCE: Rodger A et al. Lancet 2019, May 2. doi: 10.1016/S0140-6736[19]304018-0.

The risk of HIV transmission between serodiscordant male gay couples is effectively zero if the viral load is completely suppressed with antiretroviral therapy, according to a new paper published in the Lancet.

NIAID

The prospective observational PARTNER2 study (Lancet 2019 May 2. doi: 10.1016/S0140-6736[19]304018-0) followed 782 serodiscordant gay couples from 14 European countries, where the HIV-positive partner had to be virally suppressed to below 200 copies of HIV-1 RNA per milliliter, and the couple was engaging in condomless sex without using pre- or postexposure prophylaxis.

After a median follow-up of 2 years, there was not a single case of HIV transmission between couples, representing a transmission rate of zero. The study did record 15 new HIV infections during follow-up but these were all phylogenetically linked to sources other than the HIV-positive partner.

The HIV-positive partners had been on antiretroviral therapy for a median of 4.3 years – most on regimens of three or more drugs – with high levels of adherence. During the follow-up period, 37 HIV-positive partners (5%) reported missing their antiretroviral therapy for more than 4 consecutive days.

“Our results give equivalence of evidence for gay men as for heterosexual couples and indicate that the risk of HIV transmission when HIV viral load is suppressed is effectively zero for both anal and vaginal sex,” wrote Dr. Alison J. Rodger of the Institute for Global Health at University College London, and coauthors. “These findings emphasize the importance of regular monitoring to ensure HIV viral load remains suppressed and supporting HIV-positive people with long-term adherence.”

Around one-quarter of the HIV-negative men and 27% of the HIV-positive men reported a sexually-transmitted infection during follow-up; the most common infections were syphilis, gonorrhea, and chlamydia.

The study noted six additional cases of seroconversion of HIV-negative partners. However, these occurred outside the eligible couple-years of the follow-up period. They were ineligible due to no questionnaire about sexual behavior having been completed by either partner in the couple, a lack of condomless sex between the couple, use of postexposure prophylaxis, or a lack of viral load measurement for the HIV-positive partner in the past year.

The authors did note that the study population was predominantly white and with a median age of 38 years, while most HIV transmission occurs in young people aged under 25 years.

“The results from the PARTNER studies support wider dissemination of the message of the U=U [Undetectable equals Untransmittable] campaign that risk of transmission of HIV in the context of virally suppressive ART is zero,” they wrote.

The study was supported by the National Institute for Health Research, the British HIV Association, the Danish National Research Foundation, ViiV Healthcare, Gilead Sciences, Augustinus Fonden, and A P Møller Fonden. Fourteen authors declared grants, personal fees and other support from the pharmaceutical sector.

SOURCE: Rodger A et al. Lancet 2019, May 2. doi: 10.1016/S0140-6736[19]304018-0.

The risk of HIV transmission between serodiscordant male gay couples is effectively zero if the viral load is completely suppressed with antiretroviral therapy, according to a new paper published in the Lancet.

NIAID

The prospective observational PARTNER2 study (Lancet 2019 May 2. doi: 10.1016/S0140-6736[19]304018-0) followed 782 serodiscordant gay couples from 14 European countries, where the HIV-positive partner had to be virally suppressed to below 200 copies of HIV-1 RNA per milliliter, and the couple was engaging in condomless sex without using pre- or postexposure prophylaxis.

After a median follow-up of 2 years, there was not a single case of HIV transmission between couples, representing a transmission rate of zero. The study did record 15 new HIV infections during follow-up but these were all phylogenetically linked to sources other than the HIV-positive partner.

The HIV-positive partners had been on antiretroviral therapy for a median of 4.3 years – most on regimens of three or more drugs – with high levels of adherence. During the follow-up period, 37 HIV-positive partners (5%) reported missing their antiretroviral therapy for more than 4 consecutive days.

“Our results give equivalence of evidence for gay men as for heterosexual couples and indicate that the risk of HIV transmission when HIV viral load is suppressed is effectively zero for both anal and vaginal sex,” wrote Dr. Alison J. Rodger of the Institute for Global Health at University College London, and coauthors. “These findings emphasize the importance of regular monitoring to ensure HIV viral load remains suppressed and supporting HIV-positive people with long-term adherence.”

Around one-quarter of the HIV-negative men and 27% of the HIV-positive men reported a sexually-transmitted infection during follow-up; the most common infections were syphilis, gonorrhea, and chlamydia.

The study noted six additional cases of seroconversion of HIV-negative partners. However, these occurred outside the eligible couple-years of the follow-up period. They were ineligible due to no questionnaire about sexual behavior having been completed by either partner in the couple, a lack of condomless sex between the couple, use of postexposure prophylaxis, or a lack of viral load measurement for the HIV-positive partner in the past year.

The authors did note that the study population was predominantly white and with a median age of 38 years, while most HIV transmission occurs in young people aged under 25 years.

“The results from the PARTNER studies support wider dissemination of the message of the U=U [Undetectable equals Untransmittable] campaign that risk of transmission of HIV in the context of virally suppressive ART is zero,” they wrote.

The study was supported by the National Institute for Health Research, the British HIV Association, the Danish National Research Foundation, ViiV Healthcare, Gilead Sciences, Augustinus Fonden, and A P Møller Fonden. Fourteen authors declared grants, personal fees and other support from the pharmaceutical sector.

SOURCE: Rodger A et al. Lancet 2019, May 2. doi: 10.1016/S0140-6736[19]304018-0.

Researchers have identified several risk factors associated with gastrointestinal (GI) bleeding in adult patients with von Willebrand disease (VWD), based on findings from a retrospective analysis.

“[We] evaluated prevalence and risk factors of GIB among individuals with and without VWD, using a large national database,” wrote Anastasia Tsagianni, MD, of the University of Pittsburgh, and colleagues. The findings were published in Thrombosis Research.

The researchers retrospectively reviewed discharge data from the National Inpatient Sample database. The team analyzed correlates of GI bleeding among patients with VWD and estimated prevalence rates using measures in the database. Risk factors for GI bleeding in VWD were correlated via multivariable logistic regression.

Between Jan. 1, 2009, and Dec. 31, 2014, there were 16,640 admissions with VWD and 618 were admitted with GI bleeding, the researchers reported. After analysis, the researchers found that the prevalence of GI bleeding was 3.7% and 1.49% in VWD and non-VWD patients, respectively – a 2.5-fold greater rate in VWD patients.

“Comorbidities associated with greater [GI bleeding] risk in individuals with VWD include past surgery, hypertension, hyperlipidemia, smoking, renal disease, hepatitis C, thrombocytopenia, or liver disease,” the researchers wrote.

In the multivariable analysis, the factors associated with GI bleeding were smoking status (odds ratio, 1.40), African American race (OR, 1.80), male gender (OR, 1.61), angiodysplasia (OR, 104.06), colonic diverticulitis (OR, 16.66), and hepatitis C (OR 2.17). These variables were similar to risk factors identified in the non-VWD group, the researchers noted.

“Although significant, age did not appear to be a strong risk factor for either group,” they wrote. “Steroids were not associated with increased risk for [GI bleeding] in either group.”

A key limitation of the study was the use of discharge diagnosis codes as an inclusion method, the researchers noted. As a result, misclassification bias could be present, they added.

The Pennsylvania Department of Health and the Health Resources and Services Administration funded the study. The authors reported having no conflicts of interest.

SOURCE: Tsagianni A et al. Thromb Res. 2019 Apr 17. doi: 10.1016/j.thromres.2019.04.017.

Researchers have identified several risk factors associated with gastrointestinal (GI) bleeding in adult patients with von Willebrand disease (VWD), based on findings from a retrospective analysis.

“[We] evaluated prevalence and risk factors of GIB among individuals with and without VWD, using a large national database,” wrote Anastasia Tsagianni, MD, of the University of Pittsburgh, and colleagues. The findings were published in Thrombosis Research.

The researchers retrospectively reviewed discharge data from the National Inpatient Sample database. The team analyzed correlates of GI bleeding among patients with VWD and estimated prevalence rates using measures in the database. Risk factors for GI bleeding in VWD were correlated via multivariable logistic regression.

Between Jan. 1, 2009, and Dec. 31, 2014, there were 16,640 admissions with VWD and 618 were admitted with GI bleeding, the researchers reported. After analysis, the researchers found that the prevalence of GI bleeding was 3.7% and 1.49% in VWD and non-VWD patients, respectively – a 2.5-fold greater rate in VWD patients.

“Comorbidities associated with greater [GI bleeding] risk in individuals with VWD include past surgery, hypertension, hyperlipidemia, smoking, renal disease, hepatitis C, thrombocytopenia, or liver disease,” the researchers wrote.

In the multivariable analysis, the factors associated with GI bleeding were smoking status (odds ratio, 1.40), African American race (OR, 1.80), male gender (OR, 1.61), angiodysplasia (OR, 104.06), colonic diverticulitis (OR, 16.66), and hepatitis C (OR 2.17). These variables were similar to risk factors identified in the non-VWD group, the researchers noted.

“Although significant, age did not appear to be a strong risk factor for either group,” they wrote. “Steroids were not associated with increased risk for [GI bleeding] in either group.”

A key limitation of the study was the use of discharge diagnosis codes as an inclusion method, the researchers noted. As a result, misclassification bias could be present, they added.

The Pennsylvania Department of Health and the Health Resources and Services Administration funded the study. The authors reported having no conflicts of interest.

SOURCE: Tsagianni A et al. Thromb Res. 2019 Apr 17. doi: 10.1016/j.thromres.2019.04.017.

Researchers have identified several risk factors associated with gastrointestinal (GI) bleeding in adult patients with von Willebrand disease (VWD), based on findings from a retrospective analysis.

“[We] evaluated prevalence and risk factors of GIB among individuals with and without VWD, using a large national database,” wrote Anastasia Tsagianni, MD, of the University of Pittsburgh, and colleagues. The findings were published in Thrombosis Research.

The researchers retrospectively reviewed discharge data from the National Inpatient Sample database. The team analyzed correlates of GI bleeding among patients with VWD and estimated prevalence rates using measures in the database. Risk factors for GI bleeding in VWD were correlated via multivariable logistic regression.

Between Jan. 1, 2009, and Dec. 31, 2014, there were 16,640 admissions with VWD and 618 were admitted with GI bleeding, the researchers reported. After analysis, the researchers found that the prevalence of GI bleeding was 3.7% and 1.49% in VWD and non-VWD patients, respectively – a 2.5-fold greater rate in VWD patients.

“Comorbidities associated with greater [GI bleeding] risk in individuals with VWD include past surgery, hypertension, hyperlipidemia, smoking, renal disease, hepatitis C, thrombocytopenia, or liver disease,” the researchers wrote.

In the multivariable analysis, the factors associated with GI bleeding were smoking status (odds ratio, 1.40), African American race (OR, 1.80), male gender (OR, 1.61), angiodysplasia (OR, 104.06), colonic diverticulitis (OR, 16.66), and hepatitis C (OR 2.17). These variables were similar to risk factors identified in the non-VWD group, the researchers noted.

“Although significant, age did not appear to be a strong risk factor for either group,” they wrote. “Steroids were not associated with increased risk for [GI bleeding] in either group.”

A key limitation of the study was the use of discharge diagnosis codes as an inclusion method, the researchers noted. As a result, misclassification bias could be present, they added.

The Pennsylvania Department of Health and the Health Resources and Services Administration funded the study. The authors reported having no conflicts of interest.

SOURCE: Tsagianni A et al. Thromb Res. 2019 Apr 17. doi: 10.1016/j.thromres.2019.04.017.

The Food and Drug Administration will now require that certain medications prescribed for insomnia carry a boxed warning because of associated complex sleep behaviors.

[email protected]

The Food and Drug Administration will now require that certain medications prescribed for insomnia carry a boxed warning because of associated complex sleep behaviors.

[email protected]

The Food and Drug Administration will now require that certain medications prescribed for insomnia carry a boxed warning because of associated complex sleep behaviors.

[email protected]

LAS VEGAS – Two-thirds of colon resections in the United States are open procedures, but a colorectal surgeon told colleagues that evidence shows minimally invasive surgery deserves a wider place in his field.

Why? Because minimally invasive surgery – despite its limited utilization – is linked to multiple improved outcomes in colorectal surgery, said Matthew G. Mutch, MD, chief of colon and rectal surgery at Washington University, St. Louis, in a presentation at the Annual Minimally Invasive Surgery Symposium by Global Academy for Medical Education.

“Our goal should be to offer minimally invasive surgery to as many patients as possible by as many different methods as needed,” Dr. Mutch said. “If you’re willing to take this on and do this over a regular basis, you’ll get over that learning curve and expand the number of patients you can offer laparoscopy to.”

According to Dr. Mutch, benefits of minimally invasive colorectal surgery include:

• Improved short-term outcomes – length of stay and return of bowel function, and morbidity and mortality. A 2012 retrospective study of 85,712 colon resections that found laparoscopic resections, when feasible, “had better outcomes than open colectomy in the immediate perioperative period.” (Ann Surg. 2012 Sep;256[3]462-8).
• Improved long-term outcomes: faster recovery, fewer hernias, and fewer bowel obstructions.
• Lower overall costs.
• Fewer complications in the elderly.

When it comes to laparoscopic colorectal surgery, Dr. Mutch cautioned that the robotic technology has unclear benefit in rectal cancer, and the cost in colorectal cancer is unclear.

Another alternative is to perform laparoscopic colorectal surgery through alternative extraction sites such as the rectum, vagina, stomach, and even a stoma site or perineal wound. Both transanal and transvaginal extraction are feasible and safe, he said, adding that transvaginal procedures are best performed in conjunction with a hysterectomy. One benefit of these procedures is that they avoid abdominal wall trauma. However, he cautioned that colorectal surgery is unique because a cancerous specimen cannot be morcellated and must instead be removed whole.

Dr. Mutch also discussed laparoendoscopic resection of colon polyps. Benefits include shorter length of stay and faster recovery, he said, but complications can include perforation and bleeding. And, he said, there’s currently no code for the procedure.

Global Academy for Medical Education and this news organization are owned by the same parent company. Dr. Mutch has no relevant disclosures.

LAS VEGAS – Two-thirds of colon resections in the United States are open procedures, but a colorectal surgeon told colleagues that evidence shows minimally invasive surgery deserves a wider place in his field.

Why? Because minimally invasive surgery – despite its limited utilization – is linked to multiple improved outcomes in colorectal surgery, said Matthew G. Mutch, MD, chief of colon and rectal surgery at Washington University, St. Louis, in a presentation at the Annual Minimally Invasive Surgery Symposium by Global Academy for Medical Education.

“Our goal should be to offer minimally invasive surgery to as many patients as possible by as many different methods as needed,” Dr. Mutch said. “If you’re willing to take this on and do this over a regular basis, you’ll get over that learning curve and expand the number of patients you can offer laparoscopy to.”

According to Dr. Mutch, benefits of minimally invasive colorectal surgery include:

• Improved short-term outcomes – length of stay and return of bowel function, and morbidity and mortality. A 2012 retrospective study of 85,712 colon resections that found laparoscopic resections, when feasible, “had better outcomes than open colectomy in the immediate perioperative period.” (Ann Surg. 2012 Sep;256[3]462-8).
• Improved long-term outcomes: faster recovery, fewer hernias, and fewer bowel obstructions.
• Lower overall costs.
• Fewer complications in the elderly.

When it comes to laparoscopic colorectal surgery, Dr. Mutch cautioned that the robotic technology has unclear benefit in rectal cancer, and the cost in colorectal cancer is unclear.

Another alternative is to perform laparoscopic colorectal surgery through alternative extraction sites such as the rectum, vagina, stomach, and even a stoma site or perineal wound. Both transanal and transvaginal extraction are feasible and safe, he said, adding that transvaginal procedures are best performed in conjunction with a hysterectomy. One benefit of these procedures is that they avoid abdominal wall trauma. However, he cautioned that colorectal surgery is unique because a cancerous specimen cannot be morcellated and must instead be removed whole.

Dr. Mutch also discussed laparoendoscopic resection of colon polyps. Benefits include shorter length of stay and faster recovery, he said, but complications can include perforation and bleeding. And, he said, there’s currently no code for the procedure.

Global Academy for Medical Education and this news organization are owned by the same parent company. Dr. Mutch has no relevant disclosures.

LAS VEGAS – Two-thirds of colon resections in the United States are open procedures, but a colorectal surgeon told colleagues that evidence shows minimally invasive surgery deserves a wider place in his field.

Why? Because minimally invasive surgery – despite its limited utilization – is linked to multiple improved outcomes in colorectal surgery, said Matthew G. Mutch, MD, chief of colon and rectal surgery at Washington University, St. Louis, in a presentation at the Annual Minimally Invasive Surgery Symposium by Global Academy for Medical Education.

“Our goal should be to offer minimally invasive surgery to as many patients as possible by as many different methods as needed,” Dr. Mutch said. “If you’re willing to take this on and do this over a regular basis, you’ll get over that learning curve and expand the number of patients you can offer laparoscopy to.”

According to Dr. Mutch, benefits of minimally invasive colorectal surgery include:

• Improved short-term outcomes – length of stay and return of bowel function, and morbidity and mortality. A 2012 retrospective study of 85,712 colon resections that found laparoscopic resections, when feasible, “had better outcomes than open colectomy in the immediate perioperative period.” (Ann Surg. 2012 Sep;256[3]462-8).
• Improved long-term outcomes: faster recovery, fewer hernias, and fewer bowel obstructions.
• Lower overall costs.
• Fewer complications in the elderly.

When it comes to laparoscopic colorectal surgery, Dr. Mutch cautioned that the robotic technology has unclear benefit in rectal cancer, and the cost in colorectal cancer is unclear.

Another alternative is to perform laparoscopic colorectal surgery through alternative extraction sites such as the rectum, vagina, stomach, and even a stoma site or perineal wound. Both transanal and transvaginal extraction are feasible and safe, he said, adding that transvaginal procedures are best performed in conjunction with a hysterectomy. One benefit of these procedures is that they avoid abdominal wall trauma. However, he cautioned that colorectal surgery is unique because a cancerous specimen cannot be morcellated and must instead be removed whole.

Dr. Mutch also discussed laparoendoscopic resection of colon polyps. Benefits include shorter length of stay and faster recovery, he said, but complications can include perforation and bleeding. And, he said, there’s currently no code for the procedure.

Global Academy for Medical Education and this news organization are owned by the same parent company. Dr. Mutch has no relevant disclosures.

For patients with Crohn’s disease, therapeutic drug monitoring helped identify early primary nonresponders to induction with ustekinumab, according to researchers. The report is in Clinical Gastroenterology and Hepatology.

At week 8, median trough levels of ustekinumab were 6.0 mcg per mL (interquartile range, 3.1-8.0) among patients who achieved a primary response to induction at week 16, versus 1.3 mcg/mL (IQR, 0.9-5.6 ) among primary nonresponders (P = .03). An 8-week ustekinumab trough level cutoff of 2.0 mcg/mL distinguished week 16 responders from nonresponders with an area under the receiver operating curve (AUROC) of 0.75, wrote Ninon Soufflet of University Claude Bernard Lyon 1 in France, and associates. The researchers recommended “dedicated studies” to assess whether escalating the dose of ustekinumab can benefit patients with lower trough levels at week 8.

Few studies have explored biomarkers for response to ustekinumab induction therapy. Hence, the researchers assessed the relative utility of ustekinumab trough levels, C-reactive protein (CRP) levels, and fecal calprotectin levels for predicting early primary nonresponse. All 51 study participants had active luminal Crohn’s disease and received body weight–based intravenous infusions of ustekinumab at baseline, followed by subcutaneous injections of 90 mg. Primary nonresponders did not achieve steroid-free clinical and biochemical remission at week 16, defined as a Harvey-Bradshaw Index (HBI) of 4 points or less, a CRP level under 5 mg/L, and a fecal calprotectin level under 250 mcg/g. Week 16 was chosen to account for any delayed responders, the researchers noted.

A total of 32 patients (63%) achieved remission to ustekinumab induction therapy by week 16. An 8-week trough level of 2.0 mcg/mL was found to be optimal and distinguished primary nonresponders from responders with a sensitivity of 87%, a specificity of 66%, a positive predictive value of 82%, and a negative predictive value of 75%. In prior studies, optimal thresholds exceeded 3.3 mcg/mL for achieving remission and 4.5 mcg/mL at week 26 for achieving endoscopic response, the researchers noted. They said that this discrepancy might reflect different time points for evaluation, assays for measuring ustekinumab, patient populations, and a lack of endoscopic data in their study. “The relatively small sample size and the short period of follow-up evaluation [were] substantial limitations” they acknowledged.

Learn more about therapeutic drug monitoring in IBD by reviewing the AGA Institute guideline at http://www.gastrojournal.org/article/S0016-5085(17)35963-2/fulltext.

SOURCE: Soufflet N et al. Clin Gastroenterol Hepatol. 2019 Mar 6. doi: 10.1016/j.cgh.2019.02.042. https://www.cghjournal.org/article/S1542-3565(19)30248-4/abstract

For patients with Crohn’s disease, therapeutic drug monitoring helped identify early primary nonresponders to induction with ustekinumab, according to researchers. The report is in Clinical Gastroenterology and Hepatology.

At week 8, median trough levels of ustekinumab were 6.0 mcg per mL (interquartile range, 3.1-8.0) among patients who achieved a primary response to induction at week 16, versus 1.3 mcg/mL (IQR, 0.9-5.6 ) among primary nonresponders (P = .03). An 8-week ustekinumab trough level cutoff of 2.0 mcg/mL distinguished week 16 responders from nonresponders with an area under the receiver operating curve (AUROC) of 0.75, wrote Ninon Soufflet of University Claude Bernard Lyon 1 in France, and associates. The researchers recommended “dedicated studies” to assess whether escalating the dose of ustekinumab can benefit patients with lower trough levels at week 8.

Few studies have explored biomarkers for response to ustekinumab induction therapy. Hence, the researchers assessed the relative utility of ustekinumab trough levels, C-reactive protein (CRP) levels, and fecal calprotectin levels for predicting early primary nonresponse. All 51 study participants had active luminal Crohn’s disease and received body weight–based intravenous infusions of ustekinumab at baseline, followed by subcutaneous injections of 90 mg. Primary nonresponders did not achieve steroid-free clinical and biochemical remission at week 16, defined as a Harvey-Bradshaw Index (HBI) of 4 points or less, a CRP level under 5 mg/L, and a fecal calprotectin level under 250 mcg/g. Week 16 was chosen to account for any delayed responders, the researchers noted.

A total of 32 patients (63%) achieved remission to ustekinumab induction therapy by week 16. An 8-week trough level of 2.0 mcg/mL was found to be optimal and distinguished primary nonresponders from responders with a sensitivity of 87%, a specificity of 66%, a positive predictive value of 82%, and a negative predictive value of 75%. In prior studies, optimal thresholds exceeded 3.3 mcg/mL for achieving remission and 4.5 mcg/mL at week 26 for achieving endoscopic response, the researchers noted. They said that this discrepancy might reflect different time points for evaluation, assays for measuring ustekinumab, patient populations, and a lack of endoscopic data in their study. “The relatively small sample size and the short period of follow-up evaluation [were] substantial limitations” they acknowledged.

Learn more about therapeutic drug monitoring in IBD by reviewing the AGA Institute guideline at http://www.gastrojournal.org/article/S0016-5085(17)35963-2/fulltext.

SOURCE: Soufflet N et al. Clin Gastroenterol Hepatol. 2019 Mar 6. doi: 10.1016/j.cgh.2019.02.042. https://www.cghjournal.org/article/S1542-3565(19)30248-4/abstract

For patients with Crohn’s disease, therapeutic drug monitoring helped identify early primary nonresponders to induction with ustekinumab, according to researchers. The report is in Clinical Gastroenterology and Hepatology.

At week 8, median trough levels of ustekinumab were 6.0 mcg per mL (interquartile range, 3.1-8.0) among patients who achieved a primary response to induction at week 16, versus 1.3 mcg/mL (IQR, 0.9-5.6 ) among primary nonresponders (P = .03). An 8-week ustekinumab trough level cutoff of 2.0 mcg/mL distinguished week 16 responders from nonresponders with an area under the receiver operating curve (AUROC) of 0.75, wrote Ninon Soufflet of University Claude Bernard Lyon 1 in France, and associates. The researchers recommended “dedicated studies” to assess whether escalating the dose of ustekinumab can benefit patients with lower trough levels at week 8.

Few studies have explored biomarkers for response to ustekinumab induction therapy. Hence, the researchers assessed the relative utility of ustekinumab trough levels, C-reactive protein (CRP) levels, and fecal calprotectin levels for predicting early primary nonresponse. All 51 study participants had active luminal Crohn’s disease and received body weight–based intravenous infusions of ustekinumab at baseline, followed by subcutaneous injections of 90 mg. Primary nonresponders did not achieve steroid-free clinical and biochemical remission at week 16, defined as a Harvey-Bradshaw Index (HBI) of 4 points or less, a CRP level under 5 mg/L, and a fecal calprotectin level under 250 mcg/g. Week 16 was chosen to account for any delayed responders, the researchers noted.

A total of 32 patients (63%) achieved remission to ustekinumab induction therapy by week 16. An 8-week trough level of 2.0 mcg/mL was found to be optimal and distinguished primary nonresponders from responders with a sensitivity of 87%, a specificity of 66%, a positive predictive value of 82%, and a negative predictive value of 75%. In prior studies, optimal thresholds exceeded 3.3 mcg/mL for achieving remission and 4.5 mcg/mL at week 26 for achieving endoscopic response, the researchers noted. They said that this discrepancy might reflect different time points for evaluation, assays for measuring ustekinumab, patient populations, and a lack of endoscopic data in their study. “The relatively small sample size and the short period of follow-up evaluation [were] substantial limitations” they acknowledged.

Learn more about therapeutic drug monitoring in IBD by reviewing the AGA Institute guideline at http://www.gastrojournal.org/article/S0016-5085(17)35963-2/fulltext.

SOURCE: Soufflet N et al. Clin Gastroenterol Hepatol. 2019 Mar 6. doi: 10.1016/j.cgh.2019.02.042. https://www.cghjournal.org/article/S1542-3565(19)30248-4/abstract

Uterine fibroids affect up to two-thirds of all women.¹ The current medical treatment options for uterine fibroids include on- and off-label use of oral contraceptives, hormonal intrauterine devices, gonadotropin-releasing hormone (GnRH) receptor agonists, and progestins. Data on the oral GnRH antagonist elagolix, US Food and Drug Administration–approved to treat endometriosis, were presented at the 2019 Annual Clinical and Scientific Meeting of the American College of Obstetricians and Gynecologists.
 

Study details

In the Eularis I trial, a total of 412 women with heavy menstrual bleeding (>80 mL/cycle of menstrual blood loss) were included in the double-blind, randomized, placebo-controlled, 6-month, phase 3 study. Women were premenopausal, ranged in age from 18 to 51 years, and were assigned in a 1:1:2 ratio to placebo, elagolix 300 mg twice daily, or elagolix 300 mg twice daily in combination with 1 mg estradiol/0.5 mg norethindrone acetate once-daily add-back therapy. A total of 328 women completed treatment.



At 6 months, 84.1%, 68.5%, and 8.7% of women taking elagolix alone, elagolix plus estradiol/norethindrone acetate, and placebo experienced a bleeding reduction that was 50% or greater from baseline.



Half of women who were treated with elagolix plus hormonal add-back therapy experienced adverse events, compared with 80% of women who took elagolix alone and 38% of women taking placebo. At study conclusion, the change from baseline for lumbar spine bone mass density was not significantly different from placebo for elagolix plus hormonal add-back therapy, but it was significantly different for elagolix alone compared with placebo.²
 

EULARIS II

A second study of safety and efficacy, which also was a double-blind, randomized, placebo-controlled, 6-month, phase 3 study, found that 76% of women randomly assigned to elagolix plus estradiol/norethindrone acetate experienced a bleeding reduction that was 50% or greater from baseline.³



Both EULARIS studies were funded by AbbVie, Inc.

Uterine fibroids affect up to two-thirds of all women.¹ The current medical treatment options for uterine fibroids include on- and off-label use of oral contraceptives, hormonal intrauterine devices, gonadotropin-releasing hormone (GnRH) receptor agonists, and progestins. Data on the oral GnRH antagonist elagolix, US Food and Drug Administration–approved to treat endometriosis, were presented at the 2019 Annual Clinical and Scientific Meeting of the American College of Obstetricians and Gynecologists.
 

Study details

In the Eularis I trial, a total of 412 women with heavy menstrual bleeding (>80 mL/cycle of menstrual blood loss) were included in the double-blind, randomized, placebo-controlled, 6-month, phase 3 study. Women were premenopausal, ranged in age from 18 to 51 years, and were assigned in a 1:1:2 ratio to placebo, elagolix 300 mg twice daily, or elagolix 300 mg twice daily in combination with 1 mg estradiol/0.5 mg norethindrone acetate once-daily add-back therapy. A total of 328 women completed treatment.



At 6 months, 84.1%, 68.5%, and 8.7% of women taking elagolix alone, elagolix plus estradiol/norethindrone acetate, and placebo experienced a bleeding reduction that was 50% or greater from baseline.



Half of women who were treated with elagolix plus hormonal add-back therapy experienced adverse events, compared with 80% of women who took elagolix alone and 38% of women taking placebo. At study conclusion, the change from baseline for lumbar spine bone mass density was not significantly different from placebo for elagolix plus hormonal add-back therapy, but it was significantly different for elagolix alone compared with placebo.²
 

EULARIS II

A second study of safety and efficacy, which also was a double-blind, randomized, placebo-controlled, 6-month, phase 3 study, found that 76% of women randomly assigned to elagolix plus estradiol/norethindrone acetate experienced a bleeding reduction that was 50% or greater from baseline.³



Both EULARIS studies were funded by AbbVie, Inc.

Uterine fibroids affect up to two-thirds of all women.¹ The current medical treatment options for uterine fibroids include on- and off-label use of oral contraceptives, hormonal intrauterine devices, gonadotropin-releasing hormone (GnRH) receptor agonists, and progestins. Data on the oral GnRH antagonist elagolix, US Food and Drug Administration–approved to treat endometriosis, were presented at the 2019 Annual Clinical and Scientific Meeting of the American College of Obstetricians and Gynecologists.
 

Study details

In the Eularis I trial, a total of 412 women with heavy menstrual bleeding (>80 mL/cycle of menstrual blood loss) were included in the double-blind, randomized, placebo-controlled, 6-month, phase 3 study. Women were premenopausal, ranged in age from 18 to 51 years, and were assigned in a 1:1:2 ratio to placebo, elagolix 300 mg twice daily, or elagolix 300 mg twice daily in combination with 1 mg estradiol/0.5 mg norethindrone acetate once-daily add-back therapy. A total of 328 women completed treatment.



At 6 months, 84.1%, 68.5%, and 8.7% of women taking elagolix alone, elagolix plus estradiol/norethindrone acetate, and placebo experienced a bleeding reduction that was 50% or greater from baseline.



Half of women who were treated with elagolix plus hormonal add-back therapy experienced adverse events, compared with 80% of women who took elagolix alone and 38% of women taking placebo. At study conclusion, the change from baseline for lumbar spine bone mass density was not significantly different from placebo for elagolix plus hormonal add-back therapy, but it was significantly different for elagolix alone compared with placebo.²
 

EULARIS II

A second study of safety and efficacy, which also was a double-blind, randomized, placebo-controlled, 6-month, phase 3 study, found that 76% of women randomly assigned to elagolix plus estradiol/norethindrone acetate experienced a bleeding reduction that was 50% or greater from baseline.³



Both EULARIS studies were funded by AbbVie, Inc.

Breast cancer patients with HER2-positive disease are more likely to be nonsurgical candidates for clinical trials after neoadjuvant systemic therapy if they have eradicated both invasive and ductal carcinoma in situ (DCIS) disease, according to research presented in a recent webcast from the annual meeting of the American Society of Breast Surgeons.

While there is a high rate of pathologic complete response (pCR) in HER2-postive breast cancer after neoadjuvant systemic therapy, it is difficult to determine which patients have achieved pCR because standard imaging generates a high rate of false negatives, noted Susie Sun, MD, from the University of Texas MD Anderson Cancer Center, Houston.

“Although radiological imaging such as mammograms, ultrasounds, and MRIs have been shown to be unreliable in identifying patients with pCR, we have previously determined that patients with clinically significant residual disease can be accurately identified using a combination of multimodality imaging and image-guided, vacuum-assisted biopsy to the tumor bed,” Dr. Sun said in her presentation.

In the Multicenter Trial for Eliminating Breast Cancer Surgery in Exceptional Responders With Neoadjuvant Systemic Therapy, Dr. Sun and colleagues enrolled 280 patients with T1-T2, N0-N1 HER2-positive breast cancer who had undergone HER2-targeted therapy, followed by surgical resection and axillary surgery. The researchers studied both the effects of neoadjuvant therapy patients with pCR and the clinicopathologic characteristics of residual disease to determine how patients with pCR differed from those with residual disease.

After neoadjuvant systemic therapy, 55.4% of pCR invasive cancer was eradicated in patients, 37.5% of both pCR invasive and DCIS cancer was eradicated in patients, and 17.9% of patients had eradication of only residual DCIS. Compared with patients where DCIS was not identified at initial biopsy, DCIS identification was associated with a higher likelihood of residual disease (69% vs. 57%; P = .04). The researchers found patients having hormone receptor–positive/HER2-positive disease was associated with a higher rate of predictive residual disease (26.6%), compared with patients who had hormone receptor–negative/HER2-positive disease (49.2%; odds ratio, 2.7; 95% confidence interval, P less than .0001).

“For the currently occurring trial, evaluating the safety of eliminating surgery for patients who are exceptional responders to neoadjuvant systemic therapy, eradication of both the invasive and DCIS components are necessary because DCIS may serve as a nidus for carcinoma in the future,” said Dr. Sun.

The researchers also studied the effectiveness of multimodality imaging on identifying pathologic response. The multimodality imaging consisted of a mammogram and ultrasound for all patients, and approximately 13% of patients had MRI in addition to mammogram and ultrasound. The multimodality imaging response after neoadjuvant systemic therapy had a sensitivity of 97.1% and a negative predictive value of 70.6% for detecting residual disease in the breast and lymph nodes.

“[O]ur study found that multimodality imaging was not reliable in assessing for pathologic response within the breast or lymph nodes,” said Dr. Sun. “Therefore, imaging alone cannot be used to select patients for no surgery. This requires patients who have image-guided percutaneous biopsy to safely select patients for inclusion and elimination of surgery trial.”

In a discussion session, Dr. Sun clarified the combination of multimodality imaging and image-guided percutaneous biopsy was used to select HER2-positive patients for a clinical trial, and is not standard of practice to determine pCR at the University of Texas MD Anderson Cancer Center.

Dr. Sun reported no relevant financial disclosures.

Breast cancer patients with HER2-positive disease are more likely to be nonsurgical candidates for clinical trials after neoadjuvant systemic therapy if they have eradicated both invasive and ductal carcinoma in situ (DCIS) disease, according to research presented in a recent webcast from the annual meeting of the American Society of Breast Surgeons.

While there is a high rate of pathologic complete response (pCR) in HER2-postive breast cancer after neoadjuvant systemic therapy, it is difficult to determine which patients have achieved pCR because standard imaging generates a high rate of false negatives, noted Susie Sun, MD, from the University of Texas MD Anderson Cancer Center, Houston.

“Although radiological imaging such as mammograms, ultrasounds, and MRIs have been shown to be unreliable in identifying patients with pCR, we have previously determined that patients with clinically significant residual disease can be accurately identified using a combination of multimodality imaging and image-guided, vacuum-assisted biopsy to the tumor bed,” Dr. Sun said in her presentation.

In the Multicenter Trial for Eliminating Breast Cancer Surgery in Exceptional Responders With Neoadjuvant Systemic Therapy, Dr. Sun and colleagues enrolled 280 patients with T1-T2, N0-N1 HER2-positive breast cancer who had undergone HER2-targeted therapy, followed by surgical resection and axillary surgery. The researchers studied both the effects of neoadjuvant therapy patients with pCR and the clinicopathologic characteristics of residual disease to determine how patients with pCR differed from those with residual disease.

After neoadjuvant systemic therapy, 55.4% of pCR invasive cancer was eradicated in patients, 37.5% of both pCR invasive and DCIS cancer was eradicated in patients, and 17.9% of patients had eradication of only residual DCIS. Compared with patients where DCIS was not identified at initial biopsy, DCIS identification was associated with a higher likelihood of residual disease (69% vs. 57%; P = .04). The researchers found patients having hormone receptor–positive/HER2-positive disease was associated with a higher rate of predictive residual disease (26.6%), compared with patients who had hormone receptor–negative/HER2-positive disease (49.2%; odds ratio, 2.7; 95% confidence interval, P less than .0001).

“For the currently occurring trial, evaluating the safety of eliminating surgery for patients who are exceptional responders to neoadjuvant systemic therapy, eradication of both the invasive and DCIS components are necessary because DCIS may serve as a nidus for carcinoma in the future,” said Dr. Sun.

The researchers also studied the effectiveness of multimodality imaging on identifying pathologic response. The multimodality imaging consisted of a mammogram and ultrasound for all patients, and approximately 13% of patients had MRI in addition to mammogram and ultrasound. The multimodality imaging response after neoadjuvant systemic therapy had a sensitivity of 97.1% and a negative predictive value of 70.6% for detecting residual disease in the breast and lymph nodes.

“[O]ur study found that multimodality imaging was not reliable in assessing for pathologic response within the breast or lymph nodes,” said Dr. Sun. “Therefore, imaging alone cannot be used to select patients for no surgery. This requires patients who have image-guided percutaneous biopsy to safely select patients for inclusion and elimination of surgery trial.”

In a discussion session, Dr. Sun clarified the combination of multimodality imaging and image-guided percutaneous biopsy was used to select HER2-positive patients for a clinical trial, and is not standard of practice to determine pCR at the University of Texas MD Anderson Cancer Center.

Dr. Sun reported no relevant financial disclosures.

Breast cancer patients with HER2-positive disease are more likely to be nonsurgical candidates for clinical trials after neoadjuvant systemic therapy if they have eradicated both invasive and ductal carcinoma in situ (DCIS) disease, according to research presented in a recent webcast from the annual meeting of the American Society of Breast Surgeons.

While there is a high rate of pathologic complete response (pCR) in HER2-postive breast cancer after neoadjuvant systemic therapy, it is difficult to determine which patients have achieved pCR because standard imaging generates a high rate of false negatives, noted Susie Sun, MD, from the University of Texas MD Anderson Cancer Center, Houston.

“Although radiological imaging such as mammograms, ultrasounds, and MRIs have been shown to be unreliable in identifying patients with pCR, we have previously determined that patients with clinically significant residual disease can be accurately identified using a combination of multimodality imaging and image-guided, vacuum-assisted biopsy to the tumor bed,” Dr. Sun said in her presentation.

In the Multicenter Trial for Eliminating Breast Cancer Surgery in Exceptional Responders With Neoadjuvant Systemic Therapy, Dr. Sun and colleagues enrolled 280 patients with T1-T2, N0-N1 HER2-positive breast cancer who had undergone HER2-targeted therapy, followed by surgical resection and axillary surgery. The researchers studied both the effects of neoadjuvant therapy patients with pCR and the clinicopathologic characteristics of residual disease to determine how patients with pCR differed from those with residual disease.

After neoadjuvant systemic therapy, 55.4% of pCR invasive cancer was eradicated in patients, 37.5% of both pCR invasive and DCIS cancer was eradicated in patients, and 17.9% of patients had eradication of only residual DCIS. Compared with patients where DCIS was not identified at initial biopsy, DCIS identification was associated with a higher likelihood of residual disease (69% vs. 57%; P = .04). The researchers found patients having hormone receptor–positive/HER2-positive disease was associated with a higher rate of predictive residual disease (26.6%), compared with patients who had hormone receptor–negative/HER2-positive disease (49.2%; odds ratio, 2.7; 95% confidence interval, P less than .0001).

“For the currently occurring trial, evaluating the safety of eliminating surgery for patients who are exceptional responders to neoadjuvant systemic therapy, eradication of both the invasive and DCIS components are necessary because DCIS may serve as a nidus for carcinoma in the future,” said Dr. Sun.

The researchers also studied the effectiveness of multimodality imaging on identifying pathologic response. The multimodality imaging consisted of a mammogram and ultrasound for all patients, and approximately 13% of patients had MRI in addition to mammogram and ultrasound. The multimodality imaging response after neoadjuvant systemic therapy had a sensitivity of 97.1% and a negative predictive value of 70.6% for detecting residual disease in the breast and lymph nodes.

“[O]ur study found that multimodality imaging was not reliable in assessing for pathologic response within the breast or lymph nodes,” said Dr. Sun. “Therefore, imaging alone cannot be used to select patients for no surgery. This requires patients who have image-guided percutaneous biopsy to safely select patients for inclusion and elimination of surgery trial.”

In a discussion session, Dr. Sun clarified the combination of multimodality imaging and image-guided percutaneous biopsy was used to select HER2-positive patients for a clinical trial, and is not standard of practice to determine pCR at the University of Texas MD Anderson Cancer Center.

Dr. Sun reported no relevant financial disclosures.

Buprenorphine for opioid use disorder is much less likely to be prescribed to patients who are black or who do not have health insurance, an analysis of two national surveys shows.

Researchers analyzed data from the National Ambulatory Medical Care Survey and the National Hospital Ambulatory Medical Care Survey from 2004 to 2015, including 13.4 million visits in which buprenorphine was prescribed. The analysis was published as a research letter in JAMA Psychiatry.

From 2012 to 2015, the number of ambulatory visits involving buprenorphine rose from 0.04% to 0.36%. Black patients were 77% less likely to receive a prescription for buprenorphine at their visit – even after adjustment for payment method, sex, and age – while the number of prescription received by white patients was considerably higher than for patients of any other ethnicity, wrote Pooja A. Lagisetty, MD, and coauthors.

Men were also more than twice as likely to be prescribed buprenorphine than were women, and the age group with the highest incidence of buprenorphine prescriptions was 30-50 years.

Self-pay and private health insurance were the most common payment methods, but the number of self-paying patients receiving buprenorphine prescriptions dramatically increased from 585,568 in 2004-2007 to 5.3 million in 2012-2015.

“This finding in nationally representative data builds on a previous study that reported buprenorphine treatment disparities on the basis of race/ethnicity and income in New York City,” said Dr. Lagisetty of the department of medicine at the University of Michigan, Ann Arbor, and coauthors.

However, they acknowledged that it was unclear whether the treatment disparity might in fact reflect a difference in the prevalence of opioid use disorder across ethnicities.

Commenting on the differences in payment methods, the authors noted that, despite the enactment of mental health parity legislation and the expansion of Medicaid, the proportion of self-pay visits remained relatively unchanged across the study period.

“A recent study demonstrated that half of the physicians prescribing buprenorphine in Ohio accepted cash alone, and our findings suggest that this practice may be widespread and may be associated with additional financial barriers for low-income populations,” the researchers wrote. “With rising rates of opioid overdoses, it is imperative that policy and research efforts specifically address racial/ethnic and economic differences in treatment access and engagement.”

No conflicts of interest were declared.

SOURCE: Lagisetty P et al. JAMA Psychiatry. 2019 May 8. doi: 10.1001/jamapsychiatry.2019.0876.

Buprenorphine for opioid use disorder is much less likely to be prescribed to patients who are black or who do not have health insurance, an analysis of two national surveys shows.

Researchers analyzed data from the National Ambulatory Medical Care Survey and the National Hospital Ambulatory Medical Care Survey from 2004 to 2015, including 13.4 million visits in which buprenorphine was prescribed. The analysis was published as a research letter in JAMA Psychiatry.

From 2012 to 2015, the number of ambulatory visits involving buprenorphine rose from 0.04% to 0.36%. Black patients were 77% less likely to receive a prescription for buprenorphine at their visit – even after adjustment for payment method, sex, and age – while the number of prescription received by white patients was considerably higher than for patients of any other ethnicity, wrote Pooja A. Lagisetty, MD, and coauthors.

Men were also more than twice as likely to be prescribed buprenorphine than were women, and the age group with the highest incidence of buprenorphine prescriptions was 30-50 years.

Self-pay and private health insurance were the most common payment methods, but the number of self-paying patients receiving buprenorphine prescriptions dramatically increased from 585,568 in 2004-2007 to 5.3 million in 2012-2015.

“This finding in nationally representative data builds on a previous study that reported buprenorphine treatment disparities on the basis of race/ethnicity and income in New York City,” said Dr. Lagisetty of the department of medicine at the University of Michigan, Ann Arbor, and coauthors.

However, they acknowledged that it was unclear whether the treatment disparity might in fact reflect a difference in the prevalence of opioid use disorder across ethnicities.

Commenting on the differences in payment methods, the authors noted that, despite the enactment of mental health parity legislation and the expansion of Medicaid, the proportion of self-pay visits remained relatively unchanged across the study period.

“A recent study demonstrated that half of the physicians prescribing buprenorphine in Ohio accepted cash alone, and our findings suggest that this practice may be widespread and may be associated with additional financial barriers for low-income populations,” the researchers wrote. “With rising rates of opioid overdoses, it is imperative that policy and research efforts specifically address racial/ethnic and economic differences in treatment access and engagement.”

No conflicts of interest were declared.

SOURCE: Lagisetty P et al. JAMA Psychiatry. 2019 May 8. doi: 10.1001/jamapsychiatry.2019.0876.

Buprenorphine for opioid use disorder is much less likely to be prescribed to patients who are black or who do not have health insurance, an analysis of two national surveys shows.

Researchers analyzed data from the National Ambulatory Medical Care Survey and the National Hospital Ambulatory Medical Care Survey from 2004 to 2015, including 13.4 million visits in which buprenorphine was prescribed. The analysis was published as a research letter in JAMA Psychiatry.

From 2012 to 2015, the number of ambulatory visits involving buprenorphine rose from 0.04% to 0.36%. Black patients were 77% less likely to receive a prescription for buprenorphine at their visit – even after adjustment for payment method, sex, and age – while the number of prescription received by white patients was considerably higher than for patients of any other ethnicity, wrote Pooja A. Lagisetty, MD, and coauthors.

Men were also more than twice as likely to be prescribed buprenorphine than were women, and the age group with the highest incidence of buprenorphine prescriptions was 30-50 years.

Self-pay and private health insurance were the most common payment methods, but the number of self-paying patients receiving buprenorphine prescriptions dramatically increased from 585,568 in 2004-2007 to 5.3 million in 2012-2015.

“This finding in nationally representative data builds on a previous study that reported buprenorphine treatment disparities on the basis of race/ethnicity and income in New York City,” said Dr. Lagisetty of the department of medicine at the University of Michigan, Ann Arbor, and coauthors.

However, they acknowledged that it was unclear whether the treatment disparity might in fact reflect a difference in the prevalence of opioid use disorder across ethnicities.

Commenting on the differences in payment methods, the authors noted that, despite the enactment of mental health parity legislation and the expansion of Medicaid, the proportion of self-pay visits remained relatively unchanged across the study period.

“A recent study demonstrated that half of the physicians prescribing buprenorphine in Ohio accepted cash alone, and our findings suggest that this practice may be widespread and may be associated with additional financial barriers for low-income populations,” the researchers wrote. “With rising rates of opioid overdoses, it is imperative that policy and research efforts specifically address racial/ethnic and economic differences in treatment access and engagement.”

No conflicts of interest were declared.

SOURCE: Lagisetty P et al. JAMA Psychiatry. 2019 May 8. doi: 10.1001/jamapsychiatry.2019.0876.