LONDON – Based on readily available clinical data, patients with chronic obstructive pulmonary disease (COPD) can be placed into five phenotypes with different characteristics and risk profiles, according to data generated by a cluster analysis and presented at the European Respiratory Society International Congress 2016.

The algorithm that places patients into these phenotypes was developed from a cluster analysis, reported Pierre-Regis Burgel, MD, PhD, professor of respiratory medicine, Université Réné Descartes, Paris. Mortality rates at 3 years for these phenotypes ranged from 2.6% to 49.5%

“We think that this could be the basis for recognizing clinically distinct COPD phenotypes and designing better tailored management,” Dr. Burgel explained. “We also think it has potential use in routine clinical assessment.”

To create these phenotypes, data from 2,049 COPD patients enrolled in a French-Belgian collaborative cohort were evaluated with Classification And Regression Tree (CART) analyses. The five phenotypes were derived from symptom burden, respiratory function, relative age, and presence of comorbidities.

Based on these characteristics, “a set of clinical rules” to phenotype patients was developed, according to Dr. Burgel. This algorithm was then further validated with the 3,651 COPD patients enrolled in the prospective COPD Cohorts Collaborative International Assessment (3CIA) initiative.

The two initial branches in the algorithm are created by dividing patients into those with and without cardiovascular comorbidities or diabetes. In those without cardiovascular disease, the phenotypes are defined by relative symptom severity, using cut-off scores from the modified Medical Research Council (mMRC) dyspnea assessment tool and relative degrees of lung function impairment as measured with forced expiratory volume in 1 second (FEV₁).

In those with cardiovascular disease or diabetes, mMRC-defined symptoms and FEV₁-defined lung function impairment also create decision points in the algorithm, but age and body mass index (BMI) are additional variables that direct patients to a specific phenotype. Class 4 and 5 are reached in the absence of cardiovascular disease or diabetes only, while cardiovascular disease is a prerequisite to reach Classes 4 and 5. Class 2 is the only phenotype that can be reached through the algorithm irrespective of the presence or absence of cardiovascular disease.

Using this algorithm, each of the phenotypes was associated with similar relative hierarchy in mortality in the two cohorts, even though mortality rates for each phenotype were consistently lower in the 3CIA group.

For class 1, which was reached by patients with cardiovascular disease or diabetes, the greatest symptom burden, and the lowest lung function, the mortality rates at 3 years were 49.5% and 23.2% for the French-Belgian and 3CIA cohorts, respectively.

For class 4, which was also defined by the greatest symptom burden and the lowest lung function without cardiovascular disease or diabetes the mortality rates were 45.3% and 27.3%, respectively. The lowest mortality rates, which were 2.6% and 4.0%, respectively, were found in the class 5 phenotype, which contained patients with a low symptom burden (mMRC less than or equal to 1), relatively good lung function (FEV₁ greater than or equal to 60%), and no history of cardiovascular disease or diabetes.

In classes 2 and 3, the mortality rates fell in between those of the lowest- and highest-risk phenotypes. Specifically, these 3-year mortality rates were 22.9% and 24%, respectively, in the French-Belgian cohort, and 11.1% and 14.1%, respectively, in the 3CIA cohort.

The consistency of the hierarchy of outcomes in the two cohorts provides the basis for suggesting that these phenotypes are effective for categorizing relative risk, according to Dr. Burgel. He believes that the phenotypes are clinically important, and he emphasized that the algorithm relies on clinical information that is already routinely collected and readily accessible.

“There is growing awareness that COPD phenotypes are important and are likely to be valuable in managing patients,” Dr. Burgel explained. “We feel that we have created simple rules for allocating patients that we think will be useful for research and for clinical application.”

Dr. Burgel reported financial relationships with AstraZeneca, Boehringer Ingelheim, Chiesi, GlaxoSmithKline, Novartis, Pfizer, and Vertex.

LONDON – Based on readily available clinical data, patients with chronic obstructive pulmonary disease (COPD) can be placed into five phenotypes with different characteristics and risk profiles, according to data generated by a cluster analysis and presented at the European Respiratory Society International Congress 2016.

The algorithm that places patients into these phenotypes was developed from a cluster analysis, reported Pierre-Regis Burgel, MD, PhD, professor of respiratory medicine, Université Réné Descartes, Paris. Mortality rates at 3 years for these phenotypes ranged from 2.6% to 49.5%

“We think that this could be the basis for recognizing clinically distinct COPD phenotypes and designing better tailored management,” Dr. Burgel explained. “We also think it has potential use in routine clinical assessment.”

To create these phenotypes, data from 2,049 COPD patients enrolled in a French-Belgian collaborative cohort were evaluated with Classification And Regression Tree (CART) analyses. The five phenotypes were derived from symptom burden, respiratory function, relative age, and presence of comorbidities.

Based on these characteristics, “a set of clinical rules” to phenotype patients was developed, according to Dr. Burgel. This algorithm was then further validated with the 3,651 COPD patients enrolled in the prospective COPD Cohorts Collaborative International Assessment (3CIA) initiative.

The two initial branches in the algorithm are created by dividing patients into those with and without cardiovascular comorbidities or diabetes. In those without cardiovascular disease, the phenotypes are defined by relative symptom severity, using cut-off scores from the modified Medical Research Council (mMRC) dyspnea assessment tool and relative degrees of lung function impairment as measured with forced expiratory volume in 1 second (FEV₁).

In those with cardiovascular disease or diabetes, mMRC-defined symptoms and FEV₁-defined lung function impairment also create decision points in the algorithm, but age and body mass index (BMI) are additional variables that direct patients to a specific phenotype. Class 4 and 5 are reached in the absence of cardiovascular disease or diabetes only, while cardiovascular disease is a prerequisite to reach Classes 4 and 5. Class 2 is the only phenotype that can be reached through the algorithm irrespective of the presence or absence of cardiovascular disease.

Using this algorithm, each of the phenotypes was associated with similar relative hierarchy in mortality in the two cohorts, even though mortality rates for each phenotype were consistently lower in the 3CIA group.

For class 1, which was reached by patients with cardiovascular disease or diabetes, the greatest symptom burden, and the lowest lung function, the mortality rates at 3 years were 49.5% and 23.2% for the French-Belgian and 3CIA cohorts, respectively.

For class 4, which was also defined by the greatest symptom burden and the lowest lung function without cardiovascular disease or diabetes the mortality rates were 45.3% and 27.3%, respectively. The lowest mortality rates, which were 2.6% and 4.0%, respectively, were found in the class 5 phenotype, which contained patients with a low symptom burden (mMRC less than or equal to 1), relatively good lung function (FEV₁ greater than or equal to 60%), and no history of cardiovascular disease or diabetes.

In classes 2 and 3, the mortality rates fell in between those of the lowest- and highest-risk phenotypes. Specifically, these 3-year mortality rates were 22.9% and 24%, respectively, in the French-Belgian cohort, and 11.1% and 14.1%, respectively, in the 3CIA cohort.

The consistency of the hierarchy of outcomes in the two cohorts provides the basis for suggesting that these phenotypes are effective for categorizing relative risk, according to Dr. Burgel. He believes that the phenotypes are clinically important, and he emphasized that the algorithm relies on clinical information that is already routinely collected and readily accessible.

“There is growing awareness that COPD phenotypes are important and are likely to be valuable in managing patients,” Dr. Burgel explained. “We feel that we have created simple rules for allocating patients that we think will be useful for research and for clinical application.”

Dr. Burgel reported financial relationships with AstraZeneca, Boehringer Ingelheim, Chiesi, GlaxoSmithKline, Novartis, Pfizer, and Vertex.

LONDON – Based on readily available clinical data, patients with chronic obstructive pulmonary disease (COPD) can be placed into five phenotypes with different characteristics and risk profiles, according to data generated by a cluster analysis and presented at the European Respiratory Society International Congress 2016.

The algorithm that places patients into these phenotypes was developed from a cluster analysis, reported Pierre-Regis Burgel, MD, PhD, professor of respiratory medicine, Université Réné Descartes, Paris. Mortality rates at 3 years for these phenotypes ranged from 2.6% to 49.5%

“We think that this could be the basis for recognizing clinically distinct COPD phenotypes and designing better tailored management,” Dr. Burgel explained. “We also think it has potential use in routine clinical assessment.”

To create these phenotypes, data from 2,049 COPD patients enrolled in a French-Belgian collaborative cohort were evaluated with Classification And Regression Tree (CART) analyses. The five phenotypes were derived from symptom burden, respiratory function, relative age, and presence of comorbidities.

Based on these characteristics, “a set of clinical rules” to phenotype patients was developed, according to Dr. Burgel. This algorithm was then further validated with the 3,651 COPD patients enrolled in the prospective COPD Cohorts Collaborative International Assessment (3CIA) initiative.

The two initial branches in the algorithm are created by dividing patients into those with and without cardiovascular comorbidities or diabetes. In those without cardiovascular disease, the phenotypes are defined by relative symptom severity, using cut-off scores from the modified Medical Research Council (mMRC) dyspnea assessment tool and relative degrees of lung function impairment as measured with forced expiratory volume in 1 second (FEV₁).

In those with cardiovascular disease or diabetes, mMRC-defined symptoms and FEV₁-defined lung function impairment also create decision points in the algorithm, but age and body mass index (BMI) are additional variables that direct patients to a specific phenotype. Class 4 and 5 are reached in the absence of cardiovascular disease or diabetes only, while cardiovascular disease is a prerequisite to reach Classes 4 and 5. Class 2 is the only phenotype that can be reached through the algorithm irrespective of the presence or absence of cardiovascular disease.

Using this algorithm, each of the phenotypes was associated with similar relative hierarchy in mortality in the two cohorts, even though mortality rates for each phenotype were consistently lower in the 3CIA group.

For class 1, which was reached by patients with cardiovascular disease or diabetes, the greatest symptom burden, and the lowest lung function, the mortality rates at 3 years were 49.5% and 23.2% for the French-Belgian and 3CIA cohorts, respectively.

For class 4, which was also defined by the greatest symptom burden and the lowest lung function without cardiovascular disease or diabetes the mortality rates were 45.3% and 27.3%, respectively. The lowest mortality rates, which were 2.6% and 4.0%, respectively, were found in the class 5 phenotype, which contained patients with a low symptom burden (mMRC less than or equal to 1), relatively good lung function (FEV₁ greater than or equal to 60%), and no history of cardiovascular disease or diabetes.

In classes 2 and 3, the mortality rates fell in between those of the lowest- and highest-risk phenotypes. Specifically, these 3-year mortality rates were 22.9% and 24%, respectively, in the French-Belgian cohort, and 11.1% and 14.1%, respectively, in the 3CIA cohort.

The consistency of the hierarchy of outcomes in the two cohorts provides the basis for suggesting that these phenotypes are effective for categorizing relative risk, according to Dr. Burgel. He believes that the phenotypes are clinically important, and he emphasized that the algorithm relies on clinical information that is already routinely collected and readily accessible.

“There is growing awareness that COPD phenotypes are important and are likely to be valuable in managing patients,” Dr. Burgel explained. “We feel that we have created simple rules for allocating patients that we think will be useful for research and for clinical application.”

Dr. Burgel reported financial relationships with AstraZeneca, Boehringer Ingelheim, Chiesi, GlaxoSmithKline, Novartis, Pfizer, and Vertex.

DURBAN, SOUTH AFRICA – Oral antiretroviral pre-exposure prophylaxis (PrEP) against HIV also reduces the risk of acquiring herpes simplex virus type 2, according to research presented at the 21st International AIDS Conference.

“Given the limited interventions for primary prevention of HSV-2, efficacy against HSV-2 provides additional benefit to oral PrEP,” observed Connie Celum, MD, professor of global health and medicine at the University of Washington, Seattle.

Bruce Jancin/Frontline Medical News

HSV-2 is, however, the only non-HIV sexually transmitted infection whose incidence is reduced by PrEP with emtricitabine/tenofovir (Truvada), the sole approved agent for oral HIV PrEP, she added.

Dr. Celum was lead author in a report from the landmark Partners PrEP study of HIV serodiscordant heterosexual Kenyan and Ugandan couples, which demonstrated that oral PrEP provided a 33% reduction in the risk of HSV-2 infection in participants with a known HSV-2-positive partner (Ann Intern Med. 2014 Jul 1;161[1]:11-9. doi: 10.7326/M13-2471).

Tenofovir has been shown to have in vitro activity against HSV-2, providing biologic plausibility to the Partners PrEP study finding, but the 90% effective concentration of the drug required to achieve strong anti-HSV-2 activity in the laboratory makes it likely that good adherence to daily oral PrEP is necessary to see the clinical benefit in terms of reduced HSV-2 acquisition, Dr. Celum said.

She also addressed other questions about the interaction between PrEP and non-HIV STIs she often receives from physicians who provide care for HIV-infected or at-risk patients.

Do STIs reduce the efficacy of oral PrEP? “My answer would be no,” Dr. Celum said. She noted that no difference in PrEP efficacy was seen between patients with and without STIs in Partners PrEP or the French IPERGAY study.

Does PrEP increase the rate of other STIs? The concern here has been that PrEP’s beneficial effect in reducing the risk of HIV infection could be counteracted by a compensatory increase in unsafe sexual practices among PrEP users, with a resultant increase in other STIs. That didn’t occur, however, in the recently reported UK PROUD randomized study of 544 men who have sex with men (MSM), which showed no increase in other STIs with the addition of daily oral PrEP (Lancet. 2016 Jan 2;387[10013]:53-60. doi: 10.1016/S0140-6736[15]00056-2).

Are STIs useful in selecting patients for PrEP by serving as a marker of increased risk for HIV? The answer is a strong yes for MSM. The iPrEX study documented that the number of MSM and transgender women who needed to be treated with PrEP for 1 year to prevent one additional case of HIV infection dropped from 62 for the group as a whole to 36 for those self-reporting condomless receptive anal intercourse and 41 for those with another STI (Lancet Infect Dis. 2014 Jun;14[6]:468-75. doi: 10.1016/S1473-3099[14]70025-8). To cast a wide net for potential beneficiaries, most PrEP programs targeting MSM offer PrEP to those with other STIs or who report engaging in condomless anal sex, Dr. Celum said.

Can PrEP programs reduce STIs through engagement in care? “I think there’s a great opportunity here,” she said. “Most programs are rolling out PrEP with quarterly visits for refills. And I think particularly in MSM and probably in young women, STI testing at those visits provides an opportunity for earlier diagnosis and treatment of STIs as well as for partner notification.”

Dr. Celum reported having no financial conflicts regarding her presentation.

[email protected]

DURBAN, SOUTH AFRICA – Oral antiretroviral pre-exposure prophylaxis (PrEP) against HIV also reduces the risk of acquiring herpes simplex virus type 2, according to research presented at the 21st International AIDS Conference.

“Given the limited interventions for primary prevention of HSV-2, efficacy against HSV-2 provides additional benefit to oral PrEP,” observed Connie Celum, MD, professor of global health and medicine at the University of Washington, Seattle.

Bruce Jancin/Frontline Medical News

HSV-2 is, however, the only non-HIV sexually transmitted infection whose incidence is reduced by PrEP with emtricitabine/tenofovir (Truvada), the sole approved agent for oral HIV PrEP, she added.

Dr. Celum was lead author in a report from the landmark Partners PrEP study of HIV serodiscordant heterosexual Kenyan and Ugandan couples, which demonstrated that oral PrEP provided a 33% reduction in the risk of HSV-2 infection in participants with a known HSV-2-positive partner (Ann Intern Med. 2014 Jul 1;161[1]:11-9. doi: 10.7326/M13-2471).

Tenofovir has been shown to have in vitro activity against HSV-2, providing biologic plausibility to the Partners PrEP study finding, but the 90% effective concentration of the drug required to achieve strong anti-HSV-2 activity in the laboratory makes it likely that good adherence to daily oral PrEP is necessary to see the clinical benefit in terms of reduced HSV-2 acquisition, Dr. Celum said.

She also addressed other questions about the interaction between PrEP and non-HIV STIs she often receives from physicians who provide care for HIV-infected or at-risk patients.

Do STIs reduce the efficacy of oral PrEP? “My answer would be no,” Dr. Celum said. She noted that no difference in PrEP efficacy was seen between patients with and without STIs in Partners PrEP or the French IPERGAY study.

Does PrEP increase the rate of other STIs? The concern here has been that PrEP’s beneficial effect in reducing the risk of HIV infection could be counteracted by a compensatory increase in unsafe sexual practices among PrEP users, with a resultant increase in other STIs. That didn’t occur, however, in the recently reported UK PROUD randomized study of 544 men who have sex with men (MSM), which showed no increase in other STIs with the addition of daily oral PrEP (Lancet. 2016 Jan 2;387[10013]:53-60. doi: 10.1016/S0140-6736[15]00056-2).

Are STIs useful in selecting patients for PrEP by serving as a marker of increased risk for HIV? The answer is a strong yes for MSM. The iPrEX study documented that the number of MSM and transgender women who needed to be treated with PrEP for 1 year to prevent one additional case of HIV infection dropped from 62 for the group as a whole to 36 for those self-reporting condomless receptive anal intercourse and 41 for those with another STI (Lancet Infect Dis. 2014 Jun;14[6]:468-75. doi: 10.1016/S1473-3099[14]70025-8). To cast a wide net for potential beneficiaries, most PrEP programs targeting MSM offer PrEP to those with other STIs or who report engaging in condomless anal sex, Dr. Celum said.

Can PrEP programs reduce STIs through engagement in care? “I think there’s a great opportunity here,” she said. “Most programs are rolling out PrEP with quarterly visits for refills. And I think particularly in MSM and probably in young women, STI testing at those visits provides an opportunity for earlier diagnosis and treatment of STIs as well as for partner notification.”

Dr. Celum reported having no financial conflicts regarding her presentation.

[email protected]

DURBAN, SOUTH AFRICA – Oral antiretroviral pre-exposure prophylaxis (PrEP) against HIV also reduces the risk of acquiring herpes simplex virus type 2, according to research presented at the 21st International AIDS Conference.

“Given the limited interventions for primary prevention of HSV-2, efficacy against HSV-2 provides additional benefit to oral PrEP,” observed Connie Celum, MD, professor of global health and medicine at the University of Washington, Seattle.

Bruce Jancin/Frontline Medical News

HSV-2 is, however, the only non-HIV sexually transmitted infection whose incidence is reduced by PrEP with emtricitabine/tenofovir (Truvada), the sole approved agent for oral HIV PrEP, she added.

Dr. Celum was lead author in a report from the landmark Partners PrEP study of HIV serodiscordant heterosexual Kenyan and Ugandan couples, which demonstrated that oral PrEP provided a 33% reduction in the risk of HSV-2 infection in participants with a known HSV-2-positive partner (Ann Intern Med. 2014 Jul 1;161[1]:11-9. doi: 10.7326/M13-2471).

Tenofovir has been shown to have in vitro activity against HSV-2, providing biologic plausibility to the Partners PrEP study finding, but the 90% effective concentration of the drug required to achieve strong anti-HSV-2 activity in the laboratory makes it likely that good adherence to daily oral PrEP is necessary to see the clinical benefit in terms of reduced HSV-2 acquisition, Dr. Celum said.

She also addressed other questions about the interaction between PrEP and non-HIV STIs she often receives from physicians who provide care for HIV-infected or at-risk patients.

Do STIs reduce the efficacy of oral PrEP? “My answer would be no,” Dr. Celum said. She noted that no difference in PrEP efficacy was seen between patients with and without STIs in Partners PrEP or the French IPERGAY study.

Does PrEP increase the rate of other STIs? The concern here has been that PrEP’s beneficial effect in reducing the risk of HIV infection could be counteracted by a compensatory increase in unsafe sexual practices among PrEP users, with a resultant increase in other STIs. That didn’t occur, however, in the recently reported UK PROUD randomized study of 544 men who have sex with men (MSM), which showed no increase in other STIs with the addition of daily oral PrEP (Lancet. 2016 Jan 2;387[10013]:53-60. doi: 10.1016/S0140-6736[15]00056-2).

Are STIs useful in selecting patients for PrEP by serving as a marker of increased risk for HIV? The answer is a strong yes for MSM. The iPrEX study documented that the number of MSM and transgender women who needed to be treated with PrEP for 1 year to prevent one additional case of HIV infection dropped from 62 for the group as a whole to 36 for those self-reporting condomless receptive anal intercourse and 41 for those with another STI (Lancet Infect Dis. 2014 Jun;14[6]:468-75. doi: 10.1016/S1473-3099[14]70025-8). To cast a wide net for potential beneficiaries, most PrEP programs targeting MSM offer PrEP to those with other STIs or who report engaging in condomless anal sex, Dr. Celum said.

Can PrEP programs reduce STIs through engagement in care? “I think there’s a great opportunity here,” she said. “Most programs are rolling out PrEP with quarterly visits for refills. And I think particularly in MSM and probably in young women, STI testing at those visits provides an opportunity for earlier diagnosis and treatment of STIs as well as for partner notification.”

Dr. Celum reported having no financial conflicts regarding her presentation.

[email protected]

The Food and Drug Administration has given an orphan drug designation to the compound BIV201 for the treatment of ascites, according to a press release from the drug’s manufacturer, BioVie.

The FDA designation for BIV201 is for the treatment of ascites due to all etiologies except cancer. Clinical trials could commence by 2017, if accepted by the FDA. If trials are successful, other applications for BIV201 could be tested. BIV201 is a vasoconstricter, and could also be used to treat diseases like type 1 hepatorenal syndrome, esophageal variceal bleeds, and sepsis.

Ascites, a common complication of liver cirrhosis, has no specific approved treatment, and 40% of patients diagnosed with ascites die within 2 years. Other treatments may work initially, but become ineffective as the patient worsens. Treatment costs in the United States for liver cirrhosis and related complications, including ascites, totals over $4 billion.

“Orphan drug designation represents a major milestone supporting the clinical development and eventual commercialization of BIV201 therapy. It recognizes the importance of pioneering a new therapeutic approach for this relatively small group of desperately ill patients,” Jonathan Adams, BioVie CEO, said in the press release.

Find the full press release on the BioVie website.

[email protected]

The Food and Drug Administration has given an orphan drug designation to the compound BIV201 for the treatment of ascites, according to a press release from the drug’s manufacturer, BioVie.

The FDA designation for BIV201 is for the treatment of ascites due to all etiologies except cancer. Clinical trials could commence by 2017, if accepted by the FDA. If trials are successful, other applications for BIV201 could be tested. BIV201 is a vasoconstricter, and could also be used to treat diseases like type 1 hepatorenal syndrome, esophageal variceal bleeds, and sepsis.

Ascites, a common complication of liver cirrhosis, has no specific approved treatment, and 40% of patients diagnosed with ascites die within 2 years. Other treatments may work initially, but become ineffective as the patient worsens. Treatment costs in the United States for liver cirrhosis and related complications, including ascites, totals over $4 billion.

“Orphan drug designation represents a major milestone supporting the clinical development and eventual commercialization of BIV201 therapy. It recognizes the importance of pioneering a new therapeutic approach for this relatively small group of desperately ill patients,” Jonathan Adams, BioVie CEO, said in the press release.

Find the full press release on the BioVie website.

[email protected]

The Food and Drug Administration has given an orphan drug designation to the compound BIV201 for the treatment of ascites, according to a press release from the drug’s manufacturer, BioVie.

The FDA designation for BIV201 is for the treatment of ascites due to all etiologies except cancer. Clinical trials could commence by 2017, if accepted by the FDA. If trials are successful, other applications for BIV201 could be tested. BIV201 is a vasoconstricter, and could also be used to treat diseases like type 1 hepatorenal syndrome, esophageal variceal bleeds, and sepsis.

Ascites, a common complication of liver cirrhosis, has no specific approved treatment, and 40% of patients diagnosed with ascites die within 2 years. Other treatments may work initially, but become ineffective as the patient worsens. Treatment costs in the United States for liver cirrhosis and related complications, including ascites, totals over $4 billion.

“Orphan drug designation represents a major milestone supporting the clinical development and eventual commercialization of BIV201 therapy. It recognizes the importance of pioneering a new therapeutic approach for this relatively small group of desperately ill patients,” Jonathan Adams, BioVie CEO, said in the press release.

Find the full press release on the BioVie website.

[email protected]

LONDON – A cytokine known as tumor necrosis factor–related apoptosis-inducing ligand (TRAIL) is showing potential as a biomarker for evaluating the severity of sepsis and septic shock, according to results of a prospective study presented at the annual congress of the European Respiratory Society.

In a prospective study undertaken in patients administered to an intensive care unit, “lower levels of plasma TRAIL correlated with both organ system dysfunction and mortality,” reported Thomas Nicholson, MD, of Cornell University, New York.

A series of studies associating low levels of TRAIL with increased sepsis severity have attracted attention to this potential biomarker, according to Dr. Nicholson. In a mouse model of sepsis, for example, exogenous administration of TRAIL was associated with improved survival. In a clinical study conducted in CHINA that was cited by Dr. Nicholson, low levels of TRAIL correlated with lower rates of survival.

In the data presented at the ERS Congress, plasma TRAIL was collected from 108 patients on the first day of ICU admission. Of these patients 59 (54%) had sepsis and 23 (21%) had septic shock. Those with a noninfectious critical illness served as controls.

All patients with sepsis or septic shock were required to meet diagnostic criteria from the recently published Third International Consensus Definitions for Sepsis and Septic Shock (JAMA. 2016;315[8]:801-10). This is important because the newer criteria, relative to previous criteria, have “moved conceptually away from a condition defined by inflammatory biomarkers toward one that emphasizes signs of organ dysfunction,” Dr. Nicholson reported.

Although a dysregulated host response to infection is still a fundamental concept to the newer definition of sepsis, the importance of biomarkers of inflammation has been deemphasized, a change that would not be expected to favor an inflammatory cytokine as a biomarker.

Despite this, plasma TRAIL levels, which were measured with commercially available ELISA kits, were significantly lower for those with sepsis (P = .038) and for those with septic shock (P less than .001) relative to those with a noninfectious critical illness. There was a trend (P = .077) for lower plasma levels of TRAIL in patients with septic shock relative to sepsis.

In addition, there was a positive and significant correlation (r = –0.1983; P = .0397) between plasma TRAIL and degree of organ dysfunction as measured with the Sequential Organ Failure Assessment (SOFA) score. Higher plasma TRAIL levels also predicted survival at 28 days (P = .016). Although the overall mortality for patients with sepsis or septic shock in this series was 23%, there were no deaths among sepsis or septic shock patients with a TRAIL above the mean, which was 26.8 pg/mL.

“For every 10 mg/mL increase in TRAIL the odds ratio for survival increased by 1.9-fold,” Dr. Nicholson reported.

TRAIL is implicated in several processes that may explain these observations, according to Dr. Nicholson. For example, he reported that there is evidence that TRAIL induces apoptosis in neutrophils, a suspected mediator of sepsis-related injury.

“The observations in our study are consistent with a growing literature suggesting that TRAIL is an important mediator of inflammatory cells, such as neutrophils, tempering the degree of inflammation,” Dr. Nicholson explained.

More data are needed to verify that TRAIL is a clinically useful biomarker, but Dr. Nicholson emphasized that this is a promising area of research. He said the biomarker is being developed as a potential tool for evaluating sepsis severity.

Dr. Nicholson reported no relevant financial relationships.

LONDON – A cytokine known as tumor necrosis factor–related apoptosis-inducing ligand (TRAIL) is showing potential as a biomarker for evaluating the severity of sepsis and septic shock, according to results of a prospective study presented at the annual congress of the European Respiratory Society.

In a prospective study undertaken in patients administered to an intensive care unit, “lower levels of plasma TRAIL correlated with both organ system dysfunction and mortality,” reported Thomas Nicholson, MD, of Cornell University, New York.

A series of studies associating low levels of TRAIL with increased sepsis severity have attracted attention to this potential biomarker, according to Dr. Nicholson. In a mouse model of sepsis, for example, exogenous administration of TRAIL was associated with improved survival. In a clinical study conducted in CHINA that was cited by Dr. Nicholson, low levels of TRAIL correlated with lower rates of survival.

In the data presented at the ERS Congress, plasma TRAIL was collected from 108 patients on the first day of ICU admission. Of these patients 59 (54%) had sepsis and 23 (21%) had septic shock. Those with a noninfectious critical illness served as controls.

All patients with sepsis or septic shock were required to meet diagnostic criteria from the recently published Third International Consensus Definitions for Sepsis and Septic Shock (JAMA. 2016;315[8]:801-10). This is important because the newer criteria, relative to previous criteria, have “moved conceptually away from a condition defined by inflammatory biomarkers toward one that emphasizes signs of organ dysfunction,” Dr. Nicholson reported.

Although a dysregulated host response to infection is still a fundamental concept to the newer definition of sepsis, the importance of biomarkers of inflammation has been deemphasized, a change that would not be expected to favor an inflammatory cytokine as a biomarker.

Despite this, plasma TRAIL levels, which were measured with commercially available ELISA kits, were significantly lower for those with sepsis (P = .038) and for those with septic shock (P less than .001) relative to those with a noninfectious critical illness. There was a trend (P = .077) for lower plasma levels of TRAIL in patients with septic shock relative to sepsis.

In addition, there was a positive and significant correlation (r = –0.1983; P = .0397) between plasma TRAIL and degree of organ dysfunction as measured with the Sequential Organ Failure Assessment (SOFA) score. Higher plasma TRAIL levels also predicted survival at 28 days (P = .016). Although the overall mortality for patients with sepsis or septic shock in this series was 23%, there were no deaths among sepsis or septic shock patients with a TRAIL above the mean, which was 26.8 pg/mL.

“For every 10 mg/mL increase in TRAIL the odds ratio for survival increased by 1.9-fold,” Dr. Nicholson reported.

TRAIL is implicated in several processes that may explain these observations, according to Dr. Nicholson. For example, he reported that there is evidence that TRAIL induces apoptosis in neutrophils, a suspected mediator of sepsis-related injury.

“The observations in our study are consistent with a growing literature suggesting that TRAIL is an important mediator of inflammatory cells, such as neutrophils, tempering the degree of inflammation,” Dr. Nicholson explained.

More data are needed to verify that TRAIL is a clinically useful biomarker, but Dr. Nicholson emphasized that this is a promising area of research. He said the biomarker is being developed as a potential tool for evaluating sepsis severity.

Dr. Nicholson reported no relevant financial relationships.

LONDON – A cytokine known as tumor necrosis factor–related apoptosis-inducing ligand (TRAIL) is showing potential as a biomarker for evaluating the severity of sepsis and septic shock, according to results of a prospective study presented at the annual congress of the European Respiratory Society.

In a prospective study undertaken in patients administered to an intensive care unit, “lower levels of plasma TRAIL correlated with both organ system dysfunction and mortality,” reported Thomas Nicholson, MD, of Cornell University, New York.

A series of studies associating low levels of TRAIL with increased sepsis severity have attracted attention to this potential biomarker, according to Dr. Nicholson. In a mouse model of sepsis, for example, exogenous administration of TRAIL was associated with improved survival. In a clinical study conducted in CHINA that was cited by Dr. Nicholson, low levels of TRAIL correlated with lower rates of survival.

In the data presented at the ERS Congress, plasma TRAIL was collected from 108 patients on the first day of ICU admission. Of these patients 59 (54%) had sepsis and 23 (21%) had septic shock. Those with a noninfectious critical illness served as controls.

All patients with sepsis or septic shock were required to meet diagnostic criteria from the recently published Third International Consensus Definitions for Sepsis and Septic Shock (JAMA. 2016;315[8]:801-10). This is important because the newer criteria, relative to previous criteria, have “moved conceptually away from a condition defined by inflammatory biomarkers toward one that emphasizes signs of organ dysfunction,” Dr. Nicholson reported.

Although a dysregulated host response to infection is still a fundamental concept to the newer definition of sepsis, the importance of biomarkers of inflammation has been deemphasized, a change that would not be expected to favor an inflammatory cytokine as a biomarker.

Despite this, plasma TRAIL levels, which were measured with commercially available ELISA kits, were significantly lower for those with sepsis (P = .038) and for those with septic shock (P less than .001) relative to those with a noninfectious critical illness. There was a trend (P = .077) for lower plasma levels of TRAIL in patients with septic shock relative to sepsis.

In addition, there was a positive and significant correlation (r = –0.1983; P = .0397) between plasma TRAIL and degree of organ dysfunction as measured with the Sequential Organ Failure Assessment (SOFA) score. Higher plasma TRAIL levels also predicted survival at 28 days (P = .016). Although the overall mortality for patients with sepsis or septic shock in this series was 23%, there were no deaths among sepsis or septic shock patients with a TRAIL above the mean, which was 26.8 pg/mL.

“For every 10 mg/mL increase in TRAIL the odds ratio for survival increased by 1.9-fold,” Dr. Nicholson reported.

TRAIL is implicated in several processes that may explain these observations, according to Dr. Nicholson. For example, he reported that there is evidence that TRAIL induces apoptosis in neutrophils, a suspected mediator of sepsis-related injury.

“The observations in our study are consistent with a growing literature suggesting that TRAIL is an important mediator of inflammatory cells, such as neutrophils, tempering the degree of inflammation,” Dr. Nicholson explained.

More data are needed to verify that TRAIL is a clinically useful biomarker, but Dr. Nicholson emphasized that this is a promising area of research. He said the biomarker is being developed as a potential tool for evaluating sepsis severity.

Dr. Nicholson reported no relevant financial relationships.

Overall, the response to Blue Ribbon Panel recommendations for guiding the Cancer Moonshot initiative were well received, though some patient advocates say a few key issues were overlooked.

In early September 2016, the Blue Ribbon Panel, a group of more than 150 scientists, clinicians, patient advocates, and industry representatives convened by the National Cancer Institutes’s National Cancer Advisory Board, published its Top 10 recommendations to guide future endeavors of the Cancer Moonshot Initiative.

The recommendations, which were informed by input from the research community and the public, emphasized “the importance of direct patient engagement in cancer research, a deeper understanding of why some therapies work and others do not, the dynamics of tumor evolution, and the need for mechanisms of data sharing, access, and analysis,” wrote Dinah S. Singer, PhD, and two other cochairs of the Blue Ribbon Panel in an article published in Science (2016 Sep 7. doi: 10.1126/science.aai7862).

“The recommendations that were announced today by the Cancer Moonshot Blue Ribbon Panel are vitally important to accomplishing the goal of the National Cancer Moonshot Initiative, which is to achieve a decade’s worth of advances in five years,” wrote American Association for Cancer Research President Nancy E. Davidson, MD, in a statement.

“The panel’s thoughtful work makes an important contribution to the Cancer Moonshot Initiative,” wrote American Society for Clinical Oncology President Daniel F. Hayes, MD, in a statement. In an interview, Dr. Hayes added that innovations in information technology and the focus on improving interoperability of electronic health records were two important strengths of the recommendations that will be “critically important to deliver high-quality, high-value oncology services to individuals with cancer.”

Michelle Esser, senior program manager at the Young Survival Coalition (YSC), agreed that the recommendations are good initial steps. However, she pointed out two issues that the recommendations overlooked. “First, is the lack of mention or understanding of the adolescent and young adult (AYA) oncology patient population,” Ms. Esser noted during an interview. “The report specifically called out pediatric cancer as an area of needed research, but AYAs, whose survival rates lag behind those of older and younger patients with a similar diagnosis, and for whom cancer is the leading cause of disease-related death, were not mentioned.”

Second, there was little mention of cancer metastasis, she said. “It is not an early-stage cancer diagnosis that kills, it is when cancer metastasizes and spreads that it becomes deadly. Out of the 10 recommendations only 1 mentions metastasis. If we want to make a difference in cancer outcomes, there needs to be focus on understanding why metastasis occurs, how to prevent it, and how to cure it.”

In order for these recommendations to really expedite the nation’s progress against cancer, “It is crucial that Congress provide the necessary funding to support the priority projects identified by the Blue Ribbon Panel and those we will hear about from the Task Force and Vice President’s Executive Reports later this year,” reported Dr. Hayes, a sentiment echoed by Dr. Davidson.

[email protected]

On Twitter @jessnicolecraig

Overall, the response to Blue Ribbon Panel recommendations for guiding the Cancer Moonshot initiative were well received, though some patient advocates say a few key issues were overlooked.

In early September 2016, the Blue Ribbon Panel, a group of more than 150 scientists, clinicians, patient advocates, and industry representatives convened by the National Cancer Institutes’s National Cancer Advisory Board, published its Top 10 recommendations to guide future endeavors of the Cancer Moonshot Initiative.

The recommendations, which were informed by input from the research community and the public, emphasized “the importance of direct patient engagement in cancer research, a deeper understanding of why some therapies work and others do not, the dynamics of tumor evolution, and the need for mechanisms of data sharing, access, and analysis,” wrote Dinah S. Singer, PhD, and two other cochairs of the Blue Ribbon Panel in an article published in Science (2016 Sep 7. doi: 10.1126/science.aai7862).

“The recommendations that were announced today by the Cancer Moonshot Blue Ribbon Panel are vitally important to accomplishing the goal of the National Cancer Moonshot Initiative, which is to achieve a decade’s worth of advances in five years,” wrote American Association for Cancer Research President Nancy E. Davidson, MD, in a statement.

“The panel’s thoughtful work makes an important contribution to the Cancer Moonshot Initiative,” wrote American Society for Clinical Oncology President Daniel F. Hayes, MD, in a statement. In an interview, Dr. Hayes added that innovations in information technology and the focus on improving interoperability of electronic health records were two important strengths of the recommendations that will be “critically important to deliver high-quality, high-value oncology services to individuals with cancer.”

Michelle Esser, senior program manager at the Young Survival Coalition (YSC), agreed that the recommendations are good initial steps. However, she pointed out two issues that the recommendations overlooked. “First, is the lack of mention or understanding of the adolescent and young adult (AYA) oncology patient population,” Ms. Esser noted during an interview. “The report specifically called out pediatric cancer as an area of needed research, but AYAs, whose survival rates lag behind those of older and younger patients with a similar diagnosis, and for whom cancer is the leading cause of disease-related death, were not mentioned.”

Second, there was little mention of cancer metastasis, she said. “It is not an early-stage cancer diagnosis that kills, it is when cancer metastasizes and spreads that it becomes deadly. Out of the 10 recommendations only 1 mentions metastasis. If we want to make a difference in cancer outcomes, there needs to be focus on understanding why metastasis occurs, how to prevent it, and how to cure it.”

In order for these recommendations to really expedite the nation’s progress against cancer, “It is crucial that Congress provide the necessary funding to support the priority projects identified by the Blue Ribbon Panel and those we will hear about from the Task Force and Vice President’s Executive Reports later this year,” reported Dr. Hayes, a sentiment echoed by Dr. Davidson.

[email protected]

On Twitter @jessnicolecraig

Overall, the response to Blue Ribbon Panel recommendations for guiding the Cancer Moonshot initiative were well received, though some patient advocates say a few key issues were overlooked.

In early September 2016, the Blue Ribbon Panel, a group of more than 150 scientists, clinicians, patient advocates, and industry representatives convened by the National Cancer Institutes’s National Cancer Advisory Board, published its Top 10 recommendations to guide future endeavors of the Cancer Moonshot Initiative.

The recommendations, which were informed by input from the research community and the public, emphasized “the importance of direct patient engagement in cancer research, a deeper understanding of why some therapies work and others do not, the dynamics of tumor evolution, and the need for mechanisms of data sharing, access, and analysis,” wrote Dinah S. Singer, PhD, and two other cochairs of the Blue Ribbon Panel in an article published in Science (2016 Sep 7. doi: 10.1126/science.aai7862).

“The recommendations that were announced today by the Cancer Moonshot Blue Ribbon Panel are vitally important to accomplishing the goal of the National Cancer Moonshot Initiative, which is to achieve a decade’s worth of advances in five years,” wrote American Association for Cancer Research President Nancy E. Davidson, MD, in a statement.

“The panel’s thoughtful work makes an important contribution to the Cancer Moonshot Initiative,” wrote American Society for Clinical Oncology President Daniel F. Hayes, MD, in a statement. In an interview, Dr. Hayes added that innovations in information technology and the focus on improving interoperability of electronic health records were two important strengths of the recommendations that will be “critically important to deliver high-quality, high-value oncology services to individuals with cancer.”

Michelle Esser, senior program manager at the Young Survival Coalition (YSC), agreed that the recommendations are good initial steps. However, she pointed out two issues that the recommendations overlooked. “First, is the lack of mention or understanding of the adolescent and young adult (AYA) oncology patient population,” Ms. Esser noted during an interview. “The report specifically called out pediatric cancer as an area of needed research, but AYAs, whose survival rates lag behind those of older and younger patients with a similar diagnosis, and for whom cancer is the leading cause of disease-related death, were not mentioned.”

Second, there was little mention of cancer metastasis, she said. “It is not an early-stage cancer diagnosis that kills, it is when cancer metastasizes and spreads that it becomes deadly. Out of the 10 recommendations only 1 mentions metastasis. If we want to make a difference in cancer outcomes, there needs to be focus on understanding why metastasis occurs, how to prevent it, and how to cure it.”

In order for these recommendations to really expedite the nation’s progress against cancer, “It is crucial that Congress provide the necessary funding to support the priority projects identified by the Blue Ribbon Panel and those we will hear about from the Task Force and Vice President’s Executive Reports later this year,” reported Dr. Hayes, a sentiment echoed by Dr. Davidson.

[email protected]

On Twitter @jessnicolecraig

The concentration of lactate in the cerebrospinal fluid accurately identifies bacterial meningitis that develops after neurosurgery, distinguishing it from other conditions, according to a report published in BMC Infectious Diseases.

In patients who have undergone neurosurgery, failure to promptly identify and treat bacterial meningitis is associated with patient mortality as high as 50%, reported Xiong Xiao of the department of neurosurgery and the China National Clinical Research Center for Neurological Diseases at Beijing Tiantan Hospital and Capital Medical University, Beijing, and associates.

Courtesy CDC

A recent small study suggested that cerebrospinal fluid (CSF) lactate was accurate at differentiating postoperative bacterial meningitis from aseptic meningitis. To examine this possibility in a larger patient population, Dr. Xiao and associates reviewed 1,672 articles in the medical literature. They found few high-quality studies of this topic, but were able to perform a meta-analysis and pool the data from five studies involving 404 postneurosurgical patients treated during a 15-year period.

CSF lactate concentration identified bacterial meningitis with a pooled sensitivity of 92% and a pooled specificity of 88%. “Moreover, this test is fast, simple, objective, and affordable, and can be widely applied in hospitals,” the investigators wrote (BMC Infect Dis. 2016;16:483. doi: 10.1186/s12879-016-1818-2).Larger prospective studies are needed to confirm this finding and to provide a more thorough understanding of the indicators of postneurosurgical meningitis, Dr. Xiao and associates added.

This study was supported by Beijing Tiantan Hospital Funds for Young Scholars, the Ministry of Science and Technology of China, and the Beijing Talents Fund. Dr. Xiao and associates reported having no relevant financial disclosures.

The concentration of lactate in the cerebrospinal fluid accurately identifies bacterial meningitis that develops after neurosurgery, distinguishing it from other conditions, according to a report published in BMC Infectious Diseases.

In patients who have undergone neurosurgery, failure to promptly identify and treat bacterial meningitis is associated with patient mortality as high as 50%, reported Xiong Xiao of the department of neurosurgery and the China National Clinical Research Center for Neurological Diseases at Beijing Tiantan Hospital and Capital Medical University, Beijing, and associates.

Courtesy CDC

A recent small study suggested that cerebrospinal fluid (CSF) lactate was accurate at differentiating postoperative bacterial meningitis from aseptic meningitis. To examine this possibility in a larger patient population, Dr. Xiao and associates reviewed 1,672 articles in the medical literature. They found few high-quality studies of this topic, but were able to perform a meta-analysis and pool the data from five studies involving 404 postneurosurgical patients treated during a 15-year period.

CSF lactate concentration identified bacterial meningitis with a pooled sensitivity of 92% and a pooled specificity of 88%. “Moreover, this test is fast, simple, objective, and affordable, and can be widely applied in hospitals,” the investigators wrote (BMC Infect Dis. 2016;16:483. doi: 10.1186/s12879-016-1818-2).Larger prospective studies are needed to confirm this finding and to provide a more thorough understanding of the indicators of postneurosurgical meningitis, Dr. Xiao and associates added.

This study was supported by Beijing Tiantan Hospital Funds for Young Scholars, the Ministry of Science and Technology of China, and the Beijing Talents Fund. Dr. Xiao and associates reported having no relevant financial disclosures.

The concentration of lactate in the cerebrospinal fluid accurately identifies bacterial meningitis that develops after neurosurgery, distinguishing it from other conditions, according to a report published in BMC Infectious Diseases.

In patients who have undergone neurosurgery, failure to promptly identify and treat bacterial meningitis is associated with patient mortality as high as 50%, reported Xiong Xiao of the department of neurosurgery and the China National Clinical Research Center for Neurological Diseases at Beijing Tiantan Hospital and Capital Medical University, Beijing, and associates.

Courtesy CDC

A recent small study suggested that cerebrospinal fluid (CSF) lactate was accurate at differentiating postoperative bacterial meningitis from aseptic meningitis. To examine this possibility in a larger patient population, Dr. Xiao and associates reviewed 1,672 articles in the medical literature. They found few high-quality studies of this topic, but were able to perform a meta-analysis and pool the data from five studies involving 404 postneurosurgical patients treated during a 15-year period.

CSF lactate concentration identified bacterial meningitis with a pooled sensitivity of 92% and a pooled specificity of 88%. “Moreover, this test is fast, simple, objective, and affordable, and can be widely applied in hospitals,” the investigators wrote (BMC Infect Dis. 2016;16:483. doi: 10.1186/s12879-016-1818-2).Larger prospective studies are needed to confirm this finding and to provide a more thorough understanding of the indicators of postneurosurgical meningitis, Dr. Xiao and associates added.

This study was supported by Beijing Tiantan Hospital Funds for Young Scholars, the Ministry of Science and Technology of China, and the Beijing Talents Fund. Dr. Xiao and associates reported having no relevant financial disclosures.

Lenalidomide monotherapy demonstrated “meaningful” antitumor activity in patients with relapsed or recurrent aggressive adult T-cell leukemia/lymphoma (ATL), according to new findings.

Among 26 patients enrolled in the study, 11 responses were observed, for an overall response rate of 42% (95% CI, 23%-63%). This included four complete responses and one unconfirmed complete response.

The tumor control rate was 73%, achieved in 19 patients, and the toxicity profile was manageable. Overall, these findings hint at the potential of lenalidomide to “become a treatment option in this patient population,” wrote Takashi Ishida, MD, of Nagoya City University Graduate School of Medical Sciences, Aichi, Japan, and his colleagues (J Clin Oncol. 2016 Sep 12. doi: 10.1200/JCO.2016.67.7732).

ATL is a difficult disease to treat, and it has a poor prognosis, as it is resistant to conventional chemotherapeutic agents and treatment options are currently limited. Lenalidomide, an oral immunomodulatory agent, has demonstrated both antiproliferative and antineoplastic activity in B-cell lymphomas in preclinical studies, and a previous phase I trial established a maximum tolerated dosage (25 mg/d) in a small cohort of Japanese patients with relapsed ATL or other peripheral T-cell lymphomas (PTCL).

Based on these preliminary results, Dr. Ishida and his coauthors designed the current multicenter phase II study, to evaluate the efficacy and safety of lenalidomide monotherapy in 26 patients with relapsed or recurrent ATL.­­­

At a median follow-up of 3.9 months, responses were observed in 33% of patients (5 of 15) with acute disease, 57% (4 of 7) with lymphoma, and 50% (2 of 4) for unfavorable chronic ATL. Patient responses according to disease site were 31% for target (nodal and extranodal) lesions, 75% for cutaneous lesions, and 60% for peripheral blood. 

The median time to relapse was 1.9 months (range, 1.8-3.7 months), while the median time to progression was 3.8 months (95% CI, 1.9 to not estimable [NE]). The median and mean duration of response for the entire cohort were NE (95% CI, 0.5 months to NE) and 5.2 months (range, 0 to 16.6 months), respectively.

Progression-free survival was 3.8 months (95% CI, 1.9 months to NE) and for overall survival, it was 20.3 months (95% CI, 9.1 months to NE).

Adverse events occurred in more than 20% of patients and the most common hematologic event was thrombocytopenia (77%). The most common nonhematologic event was increased C-reactive protein (42%), and hypoalbuminemia and hypoproteinemia were observed in about a third of patients, as were constipation, hyponatremia, and hypocalcemia (all 31%).

Dr. Ishida and several coauthors reported multiple relationships with industry, including Celgene K.K. (Tokyo), the study’s sponsor.

Lenalidomide monotherapy demonstrated “meaningful” antitumor activity in patients with relapsed or recurrent aggressive adult T-cell leukemia/lymphoma (ATL), according to new findings.

Among 26 patients enrolled in the study, 11 responses were observed, for an overall response rate of 42% (95% CI, 23%-63%). This included four complete responses and one unconfirmed complete response.

The tumor control rate was 73%, achieved in 19 patients, and the toxicity profile was manageable. Overall, these findings hint at the potential of lenalidomide to “become a treatment option in this patient population,” wrote Takashi Ishida, MD, of Nagoya City University Graduate School of Medical Sciences, Aichi, Japan, and his colleagues (J Clin Oncol. 2016 Sep 12. doi: 10.1200/JCO.2016.67.7732).

ATL is a difficult disease to treat, and it has a poor prognosis, as it is resistant to conventional chemotherapeutic agents and treatment options are currently limited. Lenalidomide, an oral immunomodulatory agent, has demonstrated both antiproliferative and antineoplastic activity in B-cell lymphomas in preclinical studies, and a previous phase I trial established a maximum tolerated dosage (25 mg/d) in a small cohort of Japanese patients with relapsed ATL or other peripheral T-cell lymphomas (PTCL).

Based on these preliminary results, Dr. Ishida and his coauthors designed the current multicenter phase II study, to evaluate the efficacy and safety of lenalidomide monotherapy in 26 patients with relapsed or recurrent ATL.­­­

At a median follow-up of 3.9 months, responses were observed in 33% of patients (5 of 15) with acute disease, 57% (4 of 7) with lymphoma, and 50% (2 of 4) for unfavorable chronic ATL. Patient responses according to disease site were 31% for target (nodal and extranodal) lesions, 75% for cutaneous lesions, and 60% for peripheral blood. 

The median time to relapse was 1.9 months (range, 1.8-3.7 months), while the median time to progression was 3.8 months (95% CI, 1.9 to not estimable [NE]). The median and mean duration of response for the entire cohort were NE (95% CI, 0.5 months to NE) and 5.2 months (range, 0 to 16.6 months), respectively.

Progression-free survival was 3.8 months (95% CI, 1.9 months to NE) and for overall survival, it was 20.3 months (95% CI, 9.1 months to NE).

Adverse events occurred in more than 20% of patients and the most common hematologic event was thrombocytopenia (77%). The most common nonhematologic event was increased C-reactive protein (42%), and hypoalbuminemia and hypoproteinemia were observed in about a third of patients, as were constipation, hyponatremia, and hypocalcemia (all 31%).

Dr. Ishida and several coauthors reported multiple relationships with industry, including Celgene K.K. (Tokyo), the study’s sponsor.

Lenalidomide monotherapy demonstrated “meaningful” antitumor activity in patients with relapsed or recurrent aggressive adult T-cell leukemia/lymphoma (ATL), according to new findings.

Among 26 patients enrolled in the study, 11 responses were observed, for an overall response rate of 42% (95% CI, 23%-63%). This included four complete responses and one unconfirmed complete response.

The tumor control rate was 73%, achieved in 19 patients, and the toxicity profile was manageable. Overall, these findings hint at the potential of lenalidomide to “become a treatment option in this patient population,” wrote Takashi Ishida, MD, of Nagoya City University Graduate School of Medical Sciences, Aichi, Japan, and his colleagues (J Clin Oncol. 2016 Sep 12. doi: 10.1200/JCO.2016.67.7732).

ATL is a difficult disease to treat, and it has a poor prognosis, as it is resistant to conventional chemotherapeutic agents and treatment options are currently limited. Lenalidomide, an oral immunomodulatory agent, has demonstrated both antiproliferative and antineoplastic activity in B-cell lymphomas in preclinical studies, and a previous phase I trial established a maximum tolerated dosage (25 mg/d) in a small cohort of Japanese patients with relapsed ATL or other peripheral T-cell lymphomas (PTCL).

Based on these preliminary results, Dr. Ishida and his coauthors designed the current multicenter phase II study, to evaluate the efficacy and safety of lenalidomide monotherapy in 26 patients with relapsed or recurrent ATL.­­­

At a median follow-up of 3.9 months, responses were observed in 33% of patients (5 of 15) with acute disease, 57% (4 of 7) with lymphoma, and 50% (2 of 4) for unfavorable chronic ATL. Patient responses according to disease site were 31% for target (nodal and extranodal) lesions, 75% for cutaneous lesions, and 60% for peripheral blood. 

The median time to relapse was 1.9 months (range, 1.8-3.7 months), while the median time to progression was 3.8 months (95% CI, 1.9 to not estimable [NE]). The median and mean duration of response for the entire cohort were NE (95% CI, 0.5 months to NE) and 5.2 months (range, 0 to 16.6 months), respectively.

Progression-free survival was 3.8 months (95% CI, 1.9 months to NE) and for overall survival, it was 20.3 months (95% CI, 9.1 months to NE).

Adverse events occurred in more than 20% of patients and the most common hematologic event was thrombocytopenia (77%). The most common nonhematologic event was increased C-reactive protein (42%), and hypoalbuminemia and hypoproteinemia were observed in about a third of patients, as were constipation, hyponatremia, and hypocalcemia (all 31%).

Dr. Ishida and several coauthors reported multiple relationships with industry, including Celgene K.K. (Tokyo), the study’s sponsor.

SAN FRANCISCO – Unexpectedly, worry predicted better cognitive performance among older adults with mild symptoms of anxiety and depression, according to a cross-sectional, community-based study.

“This just flies in the face of everything that we know about worry in the adult literature,” said Sherry A. Beaudreau, PhD, of the department of psychiatry and behavioral sciences at Stanford (Calif.) University. The findings suggest that older worriers might score lower on some cognitive measures if their worry declines through treatment, she said at the 2016 congress of the International Psychogeriatric Association.

COURTESY DR. BEAUDREAU

Old age often is marked by mild symptoms of anxiety and depression that do not meet criteria for a psychiatric diagnosis, but nonetheless predict poorer cognitive performance and mild dementia, Dr. Beaudreau said. Recent work has linked anxiety to decreased attentional control, and late life depression, to slow information processing, delayed verbal memory, and other cognitive deficits. Emerging evidence also suggests that worry leads to worse performance on tests of inhibitory ability and delayed memory, Dr. Beaudreau added.

To further test these relationships, she and her associates studied 119 older adults who were living in the San Francisco Bay area between 2010 and 2012. They averaged 74 years of age (range, 65-91 years), 92% were non-Hispanic white, and 56% were women.

Most of the cohort performed well on the Rey Auditory Verbal Learning test, which assesses word recall after a delay of 20-30 minutes, and also scored above average on condition 3 of the Delis-Kaplan Executive Function System, which is a color word assessment of inhibitory control, Dr. Beaudreau reported. Individuals also tended to score low on the Beck Anxiety Inventory and the Beck Depressive Inventory II, with average scores of 3.7 (range, 0-29) and 5.6 (0-41), respectively. The mean score on the Penn State Worry Questionnaire was 37.7, with a range of 16-76.

Regardless of whether their anxiety score was low or high, those who worried more had significantly better inhibitory control than those who worried less (P = .003), Dr. Beaudreau said. “So folks with high worry actually seemed to be doing better in terms of their inhibitory ability,” she added. “This is intriguing to me, because we assume that anxiety is affecting cognition, but worry seems to be doing something different.”

©gpointstudio/Thinkstock

High worry also predicted significantly better inhibitory control among individuals with both low and high depression scores (P = .03), she reported. For the word recall test, worry did not seem to affect performance in the absence of depression, but high worry predicted significantly better word recall among individuals with high depression scores (P = .009).

“These results suggest that psychiatric symptoms of anxiety and depression are modulated by worry severity, and it’s interesting that this finding was so consistent throughout the analyses,” Dr. Beaudreau said. Future studies should examine these relationships in groups of older psychiatric patients stratified by symptom severity rather than diagnosis, she added.

The work was supported by the Alzheimer’s Association and the Stanford/VA Alzheimer’s Center. Dr. Beaudreau had no relevant financial disclosures.

SAN FRANCISCO – Unexpectedly, worry predicted better cognitive performance among older adults with mild symptoms of anxiety and depression, according to a cross-sectional, community-based study.

“This just flies in the face of everything that we know about worry in the adult literature,” said Sherry A. Beaudreau, PhD, of the department of psychiatry and behavioral sciences at Stanford (Calif.) University. The findings suggest that older worriers might score lower on some cognitive measures if their worry declines through treatment, she said at the 2016 congress of the International Psychogeriatric Association.

COURTESY DR. BEAUDREAU

Old age often is marked by mild symptoms of anxiety and depression that do not meet criteria for a psychiatric diagnosis, but nonetheless predict poorer cognitive performance and mild dementia, Dr. Beaudreau said. Recent work has linked anxiety to decreased attentional control, and late life depression, to slow information processing, delayed verbal memory, and other cognitive deficits. Emerging evidence also suggests that worry leads to worse performance on tests of inhibitory ability and delayed memory, Dr. Beaudreau added.

To further test these relationships, she and her associates studied 119 older adults who were living in the San Francisco Bay area between 2010 and 2012. They averaged 74 years of age (range, 65-91 years), 92% were non-Hispanic white, and 56% were women.

Most of the cohort performed well on the Rey Auditory Verbal Learning test, which assesses word recall after a delay of 20-30 minutes, and also scored above average on condition 3 of the Delis-Kaplan Executive Function System, which is a color word assessment of inhibitory control, Dr. Beaudreau reported. Individuals also tended to score low on the Beck Anxiety Inventory and the Beck Depressive Inventory II, with average scores of 3.7 (range, 0-29) and 5.6 (0-41), respectively. The mean score on the Penn State Worry Questionnaire was 37.7, with a range of 16-76.

Regardless of whether their anxiety score was low or high, those who worried more had significantly better inhibitory control than those who worried less (P = .003), Dr. Beaudreau said. “So folks with high worry actually seemed to be doing better in terms of their inhibitory ability,” she added. “This is intriguing to me, because we assume that anxiety is affecting cognition, but worry seems to be doing something different.”

©gpointstudio/Thinkstock

High worry also predicted significantly better inhibitory control among individuals with both low and high depression scores (P = .03), she reported. For the word recall test, worry did not seem to affect performance in the absence of depression, but high worry predicted significantly better word recall among individuals with high depression scores (P = .009).

“These results suggest that psychiatric symptoms of anxiety and depression are modulated by worry severity, and it’s interesting that this finding was so consistent throughout the analyses,” Dr. Beaudreau said. Future studies should examine these relationships in groups of older psychiatric patients stratified by symptom severity rather than diagnosis, she added.

The work was supported by the Alzheimer’s Association and the Stanford/VA Alzheimer’s Center. Dr. Beaudreau had no relevant financial disclosures.

SAN FRANCISCO – Unexpectedly, worry predicted better cognitive performance among older adults with mild symptoms of anxiety and depression, according to a cross-sectional, community-based study.

“This just flies in the face of everything that we know about worry in the adult literature,” said Sherry A. Beaudreau, PhD, of the department of psychiatry and behavioral sciences at Stanford (Calif.) University. The findings suggest that older worriers might score lower on some cognitive measures if their worry declines through treatment, she said at the 2016 congress of the International Psychogeriatric Association.

COURTESY DR. BEAUDREAU

Old age often is marked by mild symptoms of anxiety and depression that do not meet criteria for a psychiatric diagnosis, but nonetheless predict poorer cognitive performance and mild dementia, Dr. Beaudreau said. Recent work has linked anxiety to decreased attentional control, and late life depression, to slow information processing, delayed verbal memory, and other cognitive deficits. Emerging evidence also suggests that worry leads to worse performance on tests of inhibitory ability and delayed memory, Dr. Beaudreau added.

To further test these relationships, she and her associates studied 119 older adults who were living in the San Francisco Bay area between 2010 and 2012. They averaged 74 years of age (range, 65-91 years), 92% were non-Hispanic white, and 56% were women.

Most of the cohort performed well on the Rey Auditory Verbal Learning test, which assesses word recall after a delay of 20-30 minutes, and also scored above average on condition 3 of the Delis-Kaplan Executive Function System, which is a color word assessment of inhibitory control, Dr. Beaudreau reported. Individuals also tended to score low on the Beck Anxiety Inventory and the Beck Depressive Inventory II, with average scores of 3.7 (range, 0-29) and 5.6 (0-41), respectively. The mean score on the Penn State Worry Questionnaire was 37.7, with a range of 16-76.

Regardless of whether their anxiety score was low or high, those who worried more had significantly better inhibitory control than those who worried less (P = .003), Dr. Beaudreau said. “So folks with high worry actually seemed to be doing better in terms of their inhibitory ability,” she added. “This is intriguing to me, because we assume that anxiety is affecting cognition, but worry seems to be doing something different.”

©gpointstudio/Thinkstock

High worry also predicted significantly better inhibitory control among individuals with both low and high depression scores (P = .03), she reported. For the word recall test, worry did not seem to affect performance in the absence of depression, but high worry predicted significantly better word recall among individuals with high depression scores (P = .009).

“These results suggest that psychiatric symptoms of anxiety and depression are modulated by worry severity, and it’s interesting that this finding was so consistent throughout the analyses,” Dr. Beaudreau said. Future studies should examine these relationships in groups of older psychiatric patients stratified by symptom severity rather than diagnosis, she added.

The work was supported by the Alzheimer’s Association and the Stanford/VA Alzheimer’s Center. Dr. Beaudreau had no relevant financial disclosures.

Pancreatic cancer patients who received neoadjuvant therapy (NAT) followed by resection had better outcomes than did those who underwent upfront resection, investigators report.

Among patients with clinical stage I or II resected pancreatic head adenocarcinoma, the median survival was higher among those who had received NAT, compared with those who had upfront resection (26 months vs. 21 months; P less than .01).

Courtesy Dr. Lance Liotta Laboratory

The survival benefit remained consistent for both clinical stage I (29 months vs. 23 months; P less than .01) and clinical stage II (24 months vs. 20 months; P less than .01).

“This study lends further support for the use of NAT as a favorable patient selection strategy in the management of resectable, early-stage pancreatic adenocarcinoma,” wrote Ali A. Mokdad, MD, of the University of Texas Southwestern Medical Center, Dallas, and his colleagues (J Clin Oncol. 2016 Sep 19. doi: 10.1200/JCO.2016.68.5081).

The researchers compared overall survival between patients who received NAT with subsequent resection with those who received upfront resection, and they also looked at the patient subset of those who received adjuvant therapy.

The cohort included 15,237 patients with clinical stage I or II resected pancreatic head adenocarcinoma who were identified from the National Cancer Database (2006-2012). The patients who received NAT followed by curative-intent resection were matched with patients whose tumors were resected upfront, and the researchers evaluated early postoperative and oncologic outcomes.

Overall survival at 1, 3, and 5 years was 83%, 35%, and 21% in the NAT arm, compared to 71%, 29%, and 18% among patients who underwent upfront surgery, respectively. In the NAT arm, overall mortality was reduced, with an estimated hazard ratio (HR) of 0.72 (95% CI, 0.68-0.76).

In comparison with the subset of patients who received adjuvant therapy, median survival was statistically significantly longer in the NAT group (26 months vs. 23 months; stratified log-rank P less than .01). Overall survival for the adjuvant therapy group at 1, 3, and 5 years was 78%, 31%, and 18%, respectively.

Upon multivariable analysis, the overall survival difference continued to favor the NAT group vs. the adjuvant therapy arm (adjusted HR, 0.83; 95% CI, 0.78-0.89).

Early postoperative morbidity and mortality did not differ between groups. Compared with patients who received NAT, the upfront surgery group had a higher pathologic T stage (pT3 and T4: 86% vs. 73%; P less than .01) and were more likely to have positive lymph nodes (73% vs. 48%; P less than .01) and positive resection margin (24% vs. 17%; P less than .01).

The data “will hopefully provide support and encouragement for participation in the currently open clinical trials evaluating the role of NAT for clinically staged patients with resectable pancreatic cancer,” the authors concluded.

No outside funding source was disclosed. Coauthor Sam C. Wang, MD, declared a relationship with patent/intellectual panel for a prognostic gene panel for gastric cancer. All other authors declared no disclosures.

Pancreatic cancer patients who received neoadjuvant therapy (NAT) followed by resection had better outcomes than did those who underwent upfront resection, investigators report.

Among patients with clinical stage I or II resected pancreatic head adenocarcinoma, the median survival was higher among those who had received NAT, compared with those who had upfront resection (26 months vs. 21 months; P less than .01).

Courtesy Dr. Lance Liotta Laboratory

The survival benefit remained consistent for both clinical stage I (29 months vs. 23 months; P less than .01) and clinical stage II (24 months vs. 20 months; P less than .01).

“This study lends further support for the use of NAT as a favorable patient selection strategy in the management of resectable, early-stage pancreatic adenocarcinoma,” wrote Ali A. Mokdad, MD, of the University of Texas Southwestern Medical Center, Dallas, and his colleagues (J Clin Oncol. 2016 Sep 19. doi: 10.1200/JCO.2016.68.5081).

The researchers compared overall survival between patients who received NAT with subsequent resection with those who received upfront resection, and they also looked at the patient subset of those who received adjuvant therapy.

The cohort included 15,237 patients with clinical stage I or II resected pancreatic head adenocarcinoma who were identified from the National Cancer Database (2006-2012). The patients who received NAT followed by curative-intent resection were matched with patients whose tumors were resected upfront, and the researchers evaluated early postoperative and oncologic outcomes.

Overall survival at 1, 3, and 5 years was 83%, 35%, and 21% in the NAT arm, compared to 71%, 29%, and 18% among patients who underwent upfront surgery, respectively. In the NAT arm, overall mortality was reduced, with an estimated hazard ratio (HR) of 0.72 (95% CI, 0.68-0.76).

In comparison with the subset of patients who received adjuvant therapy, median survival was statistically significantly longer in the NAT group (26 months vs. 23 months; stratified log-rank P less than .01). Overall survival for the adjuvant therapy group at 1, 3, and 5 years was 78%, 31%, and 18%, respectively.

Upon multivariable analysis, the overall survival difference continued to favor the NAT group vs. the adjuvant therapy arm (adjusted HR, 0.83; 95% CI, 0.78-0.89).

Early postoperative morbidity and mortality did not differ between groups. Compared with patients who received NAT, the upfront surgery group had a higher pathologic T stage (pT3 and T4: 86% vs. 73%; P less than .01) and were more likely to have positive lymph nodes (73% vs. 48%; P less than .01) and positive resection margin (24% vs. 17%; P less than .01).

The data “will hopefully provide support and encouragement for participation in the currently open clinical trials evaluating the role of NAT for clinically staged patients with resectable pancreatic cancer,” the authors concluded.

No outside funding source was disclosed. Coauthor Sam C. Wang, MD, declared a relationship with patent/intellectual panel for a prognostic gene panel for gastric cancer. All other authors declared no disclosures.

Pancreatic cancer patients who received neoadjuvant therapy (NAT) followed by resection had better outcomes than did those who underwent upfront resection, investigators report.

Among patients with clinical stage I or II resected pancreatic head adenocarcinoma, the median survival was higher among those who had received NAT, compared with those who had upfront resection (26 months vs. 21 months; P less than .01).

Courtesy Dr. Lance Liotta Laboratory

The survival benefit remained consistent for both clinical stage I (29 months vs. 23 months; P less than .01) and clinical stage II (24 months vs. 20 months; P less than .01).

“This study lends further support for the use of NAT as a favorable patient selection strategy in the management of resectable, early-stage pancreatic adenocarcinoma,” wrote Ali A. Mokdad, MD, of the University of Texas Southwestern Medical Center, Dallas, and his colleagues (J Clin Oncol. 2016 Sep 19. doi: 10.1200/JCO.2016.68.5081).

The researchers compared overall survival between patients who received NAT with subsequent resection with those who received upfront resection, and they also looked at the patient subset of those who received adjuvant therapy.

The cohort included 15,237 patients with clinical stage I or II resected pancreatic head adenocarcinoma who were identified from the National Cancer Database (2006-2012). The patients who received NAT followed by curative-intent resection were matched with patients whose tumors were resected upfront, and the researchers evaluated early postoperative and oncologic outcomes.

Overall survival at 1, 3, and 5 years was 83%, 35%, and 21% in the NAT arm, compared to 71%, 29%, and 18% among patients who underwent upfront surgery, respectively. In the NAT arm, overall mortality was reduced, with an estimated hazard ratio (HR) of 0.72 (95% CI, 0.68-0.76).

In comparison with the subset of patients who received adjuvant therapy, median survival was statistically significantly longer in the NAT group (26 months vs. 23 months; stratified log-rank P less than .01). Overall survival for the adjuvant therapy group at 1, 3, and 5 years was 78%, 31%, and 18%, respectively.

Upon multivariable analysis, the overall survival difference continued to favor the NAT group vs. the adjuvant therapy arm (adjusted HR, 0.83; 95% CI, 0.78-0.89).

Early postoperative morbidity and mortality did not differ between groups. Compared with patients who received NAT, the upfront surgery group had a higher pathologic T stage (pT3 and T4: 86% vs. 73%; P less than .01) and were more likely to have positive lymph nodes (73% vs. 48%; P less than .01) and positive resection margin (24% vs. 17%; P less than .01).

The data “will hopefully provide support and encouragement for participation in the currently open clinical trials evaluating the role of NAT for clinically staged patients with resectable pancreatic cancer,” the authors concluded.

No outside funding source was disclosed. Coauthor Sam C. Wang, MD, declared a relationship with patent/intellectual panel for a prognostic gene panel for gastric cancer. All other authors declared no disclosures.

Rheumatoid arthritis patients who were unsuccessfully treated with anti–tumor necrosis factor drugs fared significantly better when treated with a non-TNF biologic than with a second anti-TNF drug in a 52-week, randomized, clinical trial of 300 adults.

Overall, 69% of patients who received a non-TNF biologic achieved clinical response, defined as a good or moderate EULAR response at 24 weeks, compared with 52% of patients who received a second anti-TNF drug, wrote Jacques-Eric Gottenberg, MD, PhD, of Strasbourg (France) University Hospital and his colleagues.

©kgtoh/Thinkstock

Patients were randomized to a non-TNF biologic or a second anti-TNF drug, with the choice of biologic left to the clinician. Patients were assessed at 12, 24, and 52 weeks.

“In addition to the superiority of the non-TNF treatment for the primary outcome at week 24, the non-TNF treatment was associated with a better EULAR response than a second anti-TNF drug at weeks 12 and 52,” the researchers noted. Significantly more patients in the non-TNF group reported low disease activity at 6 months and 12 months, compared with the second anti-TNF group, they added.

A total of 18 patients in the non-TNF group and 13 patients in the second anti-TNF group experienced serious adverse events; the most common were serious infections (in 33% and 77% of the non-TNF and anti-TNF groups, respectively) and cardiovascular events (33% vs. 8%, respectively).

The study was supported by the French Ministry of Health and promoted by Strasbourg University Hospital. Dr. Gottenberg disclosed financial support from AbbVie, Pfizer, and Roche, and personal fees from Bristol-Myers Squibb, Merck Sharp & Dohme, UCB, GlaxoSmithKline, and Novartis.

The findings were published online Sept. 20 (JAMA 2016;316[11]:1172-80).

Rheumatoid arthritis patients who were unsuccessfully treated with anti–tumor necrosis factor drugs fared significantly better when treated with a non-TNF biologic than with a second anti-TNF drug in a 52-week, randomized, clinical trial of 300 adults.

Overall, 69% of patients who received a non-TNF biologic achieved clinical response, defined as a good or moderate EULAR response at 24 weeks, compared with 52% of patients who received a second anti-TNF drug, wrote Jacques-Eric Gottenberg, MD, PhD, of Strasbourg (France) University Hospital and his colleagues.

©kgtoh/Thinkstock

Patients were randomized to a non-TNF biologic or a second anti-TNF drug, with the choice of biologic left to the clinician. Patients were assessed at 12, 24, and 52 weeks.

“In addition to the superiority of the non-TNF treatment for the primary outcome at week 24, the non-TNF treatment was associated with a better EULAR response than a second anti-TNF drug at weeks 12 and 52,” the researchers noted. Significantly more patients in the non-TNF group reported low disease activity at 6 months and 12 months, compared with the second anti-TNF group, they added.

A total of 18 patients in the non-TNF group and 13 patients in the second anti-TNF group experienced serious adverse events; the most common were serious infections (in 33% and 77% of the non-TNF and anti-TNF groups, respectively) and cardiovascular events (33% vs. 8%, respectively).

The study was supported by the French Ministry of Health and promoted by Strasbourg University Hospital. Dr. Gottenberg disclosed financial support from AbbVie, Pfizer, and Roche, and personal fees from Bristol-Myers Squibb, Merck Sharp & Dohme, UCB, GlaxoSmithKline, and Novartis.

The findings were published online Sept. 20 (JAMA 2016;316[11]:1172-80).

Rheumatoid arthritis patients who were unsuccessfully treated with anti–tumor necrosis factor drugs fared significantly better when treated with a non-TNF biologic than with a second anti-TNF drug in a 52-week, randomized, clinical trial of 300 adults.

Overall, 69% of patients who received a non-TNF biologic achieved clinical response, defined as a good or moderate EULAR response at 24 weeks, compared with 52% of patients who received a second anti-TNF drug, wrote Jacques-Eric Gottenberg, MD, PhD, of Strasbourg (France) University Hospital and his colleagues.

©kgtoh/Thinkstock

Patients were randomized to a non-TNF biologic or a second anti-TNF drug, with the choice of biologic left to the clinician. Patients were assessed at 12, 24, and 52 weeks.

“In addition to the superiority of the non-TNF treatment for the primary outcome at week 24, the non-TNF treatment was associated with a better EULAR response than a second anti-TNF drug at weeks 12 and 52,” the researchers noted. Significantly more patients in the non-TNF group reported low disease activity at 6 months and 12 months, compared with the second anti-TNF group, they added.

A total of 18 patients in the non-TNF group and 13 patients in the second anti-TNF group experienced serious adverse events; the most common were serious infections (in 33% and 77% of the non-TNF and anti-TNF groups, respectively) and cardiovascular events (33% vs. 8%, respectively).

The study was supported by the French Ministry of Health and promoted by Strasbourg University Hospital. Dr. Gottenberg disclosed financial support from AbbVie, Pfizer, and Roche, and personal fees from Bristol-Myers Squibb, Merck Sharp & Dohme, UCB, GlaxoSmithKline, and Novartis.

The findings were published online Sept. 20 (JAMA 2016;316[11]:1172-80).