Intensive CV Risk Management Failed to Curb Subsequent Events

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Intensive CV Risk Management Failed to Curb Subsequent Events

LISBON – Early and intensive multifactorial risk factor management in patients with screen-detected type 2 diabetes does not significantly reduce their risk of first, second, or third cardiovascular events, compared with standard diabetes care, according to a subanalysis of ADDITION-Europe.

Although the risk of experiencing a first cardiovascular event was reduced by 17% with an intensive risk management strategy, and the risk of a second, third, or even fourth CV event was lowered by 30%, 70%, and 78%, respectively, none of these differences reached statistical significance.

However, intensive risk management did not increase the risk of CV death or have any other adverse CV outcome, as previously suggested by some trials such as the oft-cited ACCORD (Action to Control Cardiovascular Risk in Diabetes) study, which was conducted in patients with long-standing disease.

These findings are consistent with the main study results, which – although negative – suggested that the early identification and treatment of type 2 diabetes was more important than the intensity of treatment. "If you find people [with type 2 diabetes] early, then they appear to have a lower risk of [subsequent CV] events," said Dr. Simon Griffin, one of the investigators of ADDITION-Europe in an interview at the annual meeting of the European Society for the Study of Diabetes.

Dr. Griffin, who is a primary care practitioner and assistant director of the Medical Research Council (MRC) Epidemiology Unit in Cambridge, England, added that the trial findings show that "if you start intensive treatment early, you can reduce patients’ risk of events without apparently harming them."

ADDITION (Anglo-Danish-Dutch Study of Intensive Treatment in People With Screen Detected Diabetes in Primary Care)–Europe randomized primary care patients with screen-detected diabetes to either routine care or targeted risk factor management.

Of more than 3,000 patients with screen-detected type 2 diabetes, who had a mean age of 60 years and were identified according to World Health Organization criteria, 1,379 were randomized to routine care and 1,678 to intensive risk factor management. The latter included lifestyle interventions (dietary advice, increased physical activity, and smoking cessation) and targeted blood glucose, blood pressure, and cholesterol control, as well as the prescription of daily low-dose aspirin.

As reported recently in the Lancet (2011;378:156-167), the intensive risk management strategy resulted in slight – but significant – improvement in CV risk factors such as HbA1c, total cholesterol, and blood pressure, but produced a small, nonsignificant decrease in the incidence of a first CV event and death. The aim of the present analysis was to see if there was any greater effect on the incidence of experiencing a subsequent CV event.

After a mean follow-up of 5.3 years, 167 patients experienced a single CV event and 71 had experienced multiple events. Patients who experienced more than one event were more likely to be smokers, male, older, and unemployed.

Revascularization was the most common type of CV event, occurring for the first time in 88 (37%) of patients and for the second or three or more times in 55 (77%) and 15 (60%) of patients.

First, second, and third or more CV death event occurred in 48 (20%), 8 (11%), and 4 (16%) patients, respectively, and first, second, and third or more nonfatal MI occurred in 61 (26%), 5 (7%), and 3 (12%) patients. Respective rates for nonfatal stoke were 17% (41 patients), 3% (2), and 8% (2).

Rebecca Simmons, Ph.D., also of the MRC Epidemiology Unit, presented the data, and noted that the overall hazard ratio for a first CV event was 0.82 (95% confidence interval, 0.65-1.05), which favored intensive over routine diabetes treatment in the patient population studied.

The HR for any further CV event was 0.77 (95% CI, 0.58-1.02), and specifically for a second, third, or fourth event was a respective 0.70 (95% CI, 0.43-1.12), 0.30 (95% CI, 0.10-0.97), and 0.22 (95% CI, 0.02-2.18).

Dr. Simmons said of the findings that "modest but significant increases in intensity of treatment was not associated with significant reduction in first or second CVD events." However, there were clearly differences in the distribution of subsequent CV events, she noted.

Dr. Griffin further commented on the differences between studies such as ACCORD (Action to Control Cardiovascular Risk in Diabetes): "If you take people who have had diabetes for 10 years and they’ve not got very good glucose or blood pressure control and you suddenly try and change that, in terms of the glucose it does not necessarily help people. But if you take people early and you try to keep their glucose as low as possible for as long as possible then it does not appear to harm them and it appears to be beneficial."

 

 

The ADDITION-Europe study is financed by multiple organizations based in the United Kingdom, Denmark, and the Netherlands, including national health services and research institutions, and via unrestricted grants from Astra, Bio-Rad, GlaxoSmithKline, HemoCue, Merck, Novo Nordisk, Pfizer, and Servier. Dr. Griffin has previously received lecture fees from GSK, Unilever, Eli Lilly, and MSD. Dr. Simmons reported no personal conflicts of interest.

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LISBON – Early and intensive multifactorial risk factor management in patients with screen-detected type 2 diabetes does not significantly reduce their risk of first, second, or third cardiovascular events, compared with standard diabetes care, according to a subanalysis of ADDITION-Europe.

Although the risk of experiencing a first cardiovascular event was reduced by 17% with an intensive risk management strategy, and the risk of a second, third, or even fourth CV event was lowered by 30%, 70%, and 78%, respectively, none of these differences reached statistical significance.

However, intensive risk management did not increase the risk of CV death or have any other adverse CV outcome, as previously suggested by some trials such as the oft-cited ACCORD (Action to Control Cardiovascular Risk in Diabetes) study, which was conducted in patients with long-standing disease.

These findings are consistent with the main study results, which – although negative – suggested that the early identification and treatment of type 2 diabetes was more important than the intensity of treatment. "If you find people [with type 2 diabetes] early, then they appear to have a lower risk of [subsequent CV] events," said Dr. Simon Griffin, one of the investigators of ADDITION-Europe in an interview at the annual meeting of the European Society for the Study of Diabetes.

Dr. Griffin, who is a primary care practitioner and assistant director of the Medical Research Council (MRC) Epidemiology Unit in Cambridge, England, added that the trial findings show that "if you start intensive treatment early, you can reduce patients’ risk of events without apparently harming them."

ADDITION (Anglo-Danish-Dutch Study of Intensive Treatment in People With Screen Detected Diabetes in Primary Care)–Europe randomized primary care patients with screen-detected diabetes to either routine care or targeted risk factor management.

Of more than 3,000 patients with screen-detected type 2 diabetes, who had a mean age of 60 years and were identified according to World Health Organization criteria, 1,379 were randomized to routine care and 1,678 to intensive risk factor management. The latter included lifestyle interventions (dietary advice, increased physical activity, and smoking cessation) and targeted blood glucose, blood pressure, and cholesterol control, as well as the prescription of daily low-dose aspirin.

As reported recently in the Lancet (2011;378:156-167), the intensive risk management strategy resulted in slight – but significant – improvement in CV risk factors such as HbA1c, total cholesterol, and blood pressure, but produced a small, nonsignificant decrease in the incidence of a first CV event and death. The aim of the present analysis was to see if there was any greater effect on the incidence of experiencing a subsequent CV event.

After a mean follow-up of 5.3 years, 167 patients experienced a single CV event and 71 had experienced multiple events. Patients who experienced more than one event were more likely to be smokers, male, older, and unemployed.

Revascularization was the most common type of CV event, occurring for the first time in 88 (37%) of patients and for the second or three or more times in 55 (77%) and 15 (60%) of patients.

First, second, and third or more CV death event occurred in 48 (20%), 8 (11%), and 4 (16%) patients, respectively, and first, second, and third or more nonfatal MI occurred in 61 (26%), 5 (7%), and 3 (12%) patients. Respective rates for nonfatal stoke were 17% (41 patients), 3% (2), and 8% (2).

Rebecca Simmons, Ph.D., also of the MRC Epidemiology Unit, presented the data, and noted that the overall hazard ratio for a first CV event was 0.82 (95% confidence interval, 0.65-1.05), which favored intensive over routine diabetes treatment in the patient population studied.

The HR for any further CV event was 0.77 (95% CI, 0.58-1.02), and specifically for a second, third, or fourth event was a respective 0.70 (95% CI, 0.43-1.12), 0.30 (95% CI, 0.10-0.97), and 0.22 (95% CI, 0.02-2.18).

Dr. Simmons said of the findings that "modest but significant increases in intensity of treatment was not associated with significant reduction in first or second CVD events." However, there were clearly differences in the distribution of subsequent CV events, she noted.

Dr. Griffin further commented on the differences between studies such as ACCORD (Action to Control Cardiovascular Risk in Diabetes): "If you take people who have had diabetes for 10 years and they’ve not got very good glucose or blood pressure control and you suddenly try and change that, in terms of the glucose it does not necessarily help people. But if you take people early and you try to keep their glucose as low as possible for as long as possible then it does not appear to harm them and it appears to be beneficial."

 

 

The ADDITION-Europe study is financed by multiple organizations based in the United Kingdom, Denmark, and the Netherlands, including national health services and research institutions, and via unrestricted grants from Astra, Bio-Rad, GlaxoSmithKline, HemoCue, Merck, Novo Nordisk, Pfizer, and Servier. Dr. Griffin has previously received lecture fees from GSK, Unilever, Eli Lilly, and MSD. Dr. Simmons reported no personal conflicts of interest.

LISBON – Early and intensive multifactorial risk factor management in patients with screen-detected type 2 diabetes does not significantly reduce their risk of first, second, or third cardiovascular events, compared with standard diabetes care, according to a subanalysis of ADDITION-Europe.

Although the risk of experiencing a first cardiovascular event was reduced by 17% with an intensive risk management strategy, and the risk of a second, third, or even fourth CV event was lowered by 30%, 70%, and 78%, respectively, none of these differences reached statistical significance.

However, intensive risk management did not increase the risk of CV death or have any other adverse CV outcome, as previously suggested by some trials such as the oft-cited ACCORD (Action to Control Cardiovascular Risk in Diabetes) study, which was conducted in patients with long-standing disease.

These findings are consistent with the main study results, which – although negative – suggested that the early identification and treatment of type 2 diabetes was more important than the intensity of treatment. "If you find people [with type 2 diabetes] early, then they appear to have a lower risk of [subsequent CV] events," said Dr. Simon Griffin, one of the investigators of ADDITION-Europe in an interview at the annual meeting of the European Society for the Study of Diabetes.

Dr. Griffin, who is a primary care practitioner and assistant director of the Medical Research Council (MRC) Epidemiology Unit in Cambridge, England, added that the trial findings show that "if you start intensive treatment early, you can reduce patients’ risk of events without apparently harming them."

ADDITION (Anglo-Danish-Dutch Study of Intensive Treatment in People With Screen Detected Diabetes in Primary Care)–Europe randomized primary care patients with screen-detected diabetes to either routine care or targeted risk factor management.

Of more than 3,000 patients with screen-detected type 2 diabetes, who had a mean age of 60 years and were identified according to World Health Organization criteria, 1,379 were randomized to routine care and 1,678 to intensive risk factor management. The latter included lifestyle interventions (dietary advice, increased physical activity, and smoking cessation) and targeted blood glucose, blood pressure, and cholesterol control, as well as the prescription of daily low-dose aspirin.

As reported recently in the Lancet (2011;378:156-167), the intensive risk management strategy resulted in slight – but significant – improvement in CV risk factors such as HbA1c, total cholesterol, and blood pressure, but produced a small, nonsignificant decrease in the incidence of a first CV event and death. The aim of the present analysis was to see if there was any greater effect on the incidence of experiencing a subsequent CV event.

After a mean follow-up of 5.3 years, 167 patients experienced a single CV event and 71 had experienced multiple events. Patients who experienced more than one event were more likely to be smokers, male, older, and unemployed.

Revascularization was the most common type of CV event, occurring for the first time in 88 (37%) of patients and for the second or three or more times in 55 (77%) and 15 (60%) of patients.

First, second, and third or more CV death event occurred in 48 (20%), 8 (11%), and 4 (16%) patients, respectively, and first, second, and third or more nonfatal MI occurred in 61 (26%), 5 (7%), and 3 (12%) patients. Respective rates for nonfatal stoke were 17% (41 patients), 3% (2), and 8% (2).

Rebecca Simmons, Ph.D., also of the MRC Epidemiology Unit, presented the data, and noted that the overall hazard ratio for a first CV event was 0.82 (95% confidence interval, 0.65-1.05), which favored intensive over routine diabetes treatment in the patient population studied.

The HR for any further CV event was 0.77 (95% CI, 0.58-1.02), and specifically for a second, third, or fourth event was a respective 0.70 (95% CI, 0.43-1.12), 0.30 (95% CI, 0.10-0.97), and 0.22 (95% CI, 0.02-2.18).

Dr. Simmons said of the findings that "modest but significant increases in intensity of treatment was not associated with significant reduction in first or second CVD events." However, there were clearly differences in the distribution of subsequent CV events, she noted.

Dr. Griffin further commented on the differences between studies such as ACCORD (Action to Control Cardiovascular Risk in Diabetes): "If you take people who have had diabetes for 10 years and they’ve not got very good glucose or blood pressure control and you suddenly try and change that, in terms of the glucose it does not necessarily help people. But if you take people early and you try to keep their glucose as low as possible for as long as possible then it does not appear to harm them and it appears to be beneficial."

 

 

The ADDITION-Europe study is financed by multiple organizations based in the United Kingdom, Denmark, and the Netherlands, including national health services and research institutions, and via unrestricted grants from Astra, Bio-Rad, GlaxoSmithKline, HemoCue, Merck, Novo Nordisk, Pfizer, and Servier. Dr. Griffin has previously received lecture fees from GSK, Unilever, Eli Lilly, and MSD. Dr. Simmons reported no personal conflicts of interest.

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FROM THE ANNUAL MEETING OF THE EUROPEAN ASSOCIATION FOR THE STUDY OF DIABETES

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Major Finding: The risk of first, second, third, and fourth cardiovascular events was reduced by 17%, 30%, 70%, and 78%, respectively, comparing intensive multifactorial risk factor management with standard care for type 2 diabetes, but differences were not statistically significant.

Data Source: The ADDITION-Europe study, an Anglo-Danish-Dutch trial of 3,000 general practice patients who were randomized to screening plus routine care or intensive, multifactorial management of type 2 diabetes with a mean follow-up of 5.3 years for cardiovascular events.

Disclosures: The study was financed by multiple organizations based in the United Kingdom, Denmark, and the Netherlands, including national health services and research institutions, and via unrestricted grants from Astra, Bio-Rad, GlaxoSmithKline, HemoCue, Merck, Novo Nordisk, Pfizer, and Servier. Dr. Griffin has previously received lecture fees from GSK, Unilever, Eli Lilly, and MSD. Dr. Simmons reported no personal conflicts of interest.

Global Change Needed to Curb Obesity Pandemic

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LONDON – The global obesity pandemic needs addressing on a global level with governments around the world taking the lead, according to a series of papers published in the Lancet.

The series is published ahead of the United Nations High-Level Meeting on Noncommunicable Diseases being held in New York next month. This U.N. meeting is set to discuss what can be done to prevent and control four key disease areas – cardiovascular diseases, cancers, chronic respiratory diseases, and diabetes – for which obesity is a known contributing or exacerbating factor.

“In many ways, the holy grail for governments today, certainly in the United Kingdom, across Europe and the United States, is improving health care while at the same time reducing costs; that's the paradox of modern health care today,” said Dr. Richard Horton, editor of The Lancet, during a press briefing to highlight the Lancet Obesity Series.

Dr. Horton added: “So far, obesity had been stubbornly resistant to traditional public health approaches, and what this series tries to do is to look at the reasons why that might be and how we might get out of that public health 'cul-de-sac' that we are in today.”

The first article in the series (Lancet 2011;378:804-14) looks at the factors that might have contributed to the rising rates of obesity seen around the globe in the past 4 decades. As rates of obesity have risen steadily and simultaneously in many countries, “that points to global drivers,” said the paper's lead author Dr. Boyd Swinburn, professor of population health and the director of the World Health Organization Collaborating Centre for Obesity Prevention at Deakin University, Melbourne.

“There is quite a lot of evidence coming out that this is largely driven be changes in the food system,” which produces a food supply comprising “increasingly processed, available, affordable, and highly promoted, 'tasty' food,” Dr. Swinburn observed.

With both high- and low-income countries affected, the solution appears to lie more with policy changes to try to improve individuals' local environments rather than try to change the public's behavior.

“Support for individuals to counteract obesogenic environments will continue to be important, but the priority should be for policies to reverse the obesogenic nature,” Dr. Swinburn and his colleagues reported.

The lead author of the second article (Lancet 2011;378:815-25), Dr. Y. Claire Wang, noted that if historical trends continue, there could be 65 million more obese adults in the United States alone by 2030, with 11 million more obese adults projected at the same time point in the United Kingdom.

This would bring the total of obese individuals to be 164 million and 26 million, in each country, respectively and, taken together, could result in 6 million to 8.5 million new cases of diabetes, 5.7 million to 7.3 million cases of heart disease and stroke, and 492,000-669,000 additional cases of cancer in both countries.

“We project that the medical costs will be substantial,” said Dr. Wang, of the department of health policy and management at Columbia University, New York. Indeed, the cost of treating essential preventable diseases that result from obesity are estimated to increase by $48 billion to $66 billion per year in the United States and by £1.9 billion to £2 billion per/year in the United Kingdom by 2030.

However, a 1% reduction in body mass index across the U.S. population could avoid up to 2.1 million to 2.4 million new cases of diabetes, 1.4 million to 1.7 million cardiovascular diseases, and 73,000-127,000 cases of cancer by 2030. Similar reductions could be achieved in the United Kingdom.

“Of course, what we have to do is to reverse this [rising obesity trend],” said Kevin Hall, Ph.D., the lead author of the third article in the series (Lancet 2011;378; 826-37). But it may not be as simple as “eat less, exercise more” suggested Dr. Hall, a senior investigator at the National Institute of Diabetes and Digestive and Kidney Diseases.

Standard guidance for weight loss is to reduce caloric intake by 500-1,000 kcal/day to lose 1-2 pounds per week, but this is fundamentally wrong. “The reason it's wrong is that it would only be true if nothing else happened to your metabolism,” Dr. Hall maintained.

Dr. Hall's research shows that for every 10 calories that can be cut from the diet per day, there would more likely be a drop of just 1 pound over 3 years, so not eating a 250-calorie chocolate bar per day could would lead to a 25-pound weight loss over 3 years.

Dr. Hall presented a web-based model that could one day help clinicians advise their patients on how many calories would need to be cut from the diet and the level or exercise needed every day to attain a certain weight loss. Currently, the model can only be used as a research tool and will need to be updated as new data become available.

 

 

With all these new data and improved understanding of what causes obesity and its health care burden and costs, the lead author of the fourth and final article (Lancet 2011;378;838-47) in the series said that it's time for governments and policy makers to act.

“Governments certainly need to lead obesity prevention, but so far few have shown any leadership whatsoever,” commented Steven L. Gortmaker, Ph.D., of the department of society, human development, and health at Harvard School of Public Health in Boston.

Dr. Gortmaker and his colleagues noted that the U.N. meeting on noncommunicable diseases “is an important opportunity for the international community to provide the leadership, global standards, and cross-agency structures needed to create a global food system that offers a healthy and secure food supply for all.”

The research was conducted under the auspices of the Collaborative Obesity Modeling Network as part of the Envision Project and supported by the National Collaborative on Childhood Obesity Research, a collaboration of the National Institutes of Health, the Centers for Disease Control and Prevention, the United States Department of Agriculture, and the Robert Wood Johnson Foundation. The NIH and the NIDDK provided additional funding.

All authors declared that they had no conflicts of interest.

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LONDON – The global obesity pandemic needs addressing on a global level with governments around the world taking the lead, according to a series of papers published in the Lancet.

The series is published ahead of the United Nations High-Level Meeting on Noncommunicable Diseases being held in New York next month. This U.N. meeting is set to discuss what can be done to prevent and control four key disease areas – cardiovascular diseases, cancers, chronic respiratory diseases, and diabetes – for which obesity is a known contributing or exacerbating factor.

“In many ways, the holy grail for governments today, certainly in the United Kingdom, across Europe and the United States, is improving health care while at the same time reducing costs; that's the paradox of modern health care today,” said Dr. Richard Horton, editor of The Lancet, during a press briefing to highlight the Lancet Obesity Series.

Dr. Horton added: “So far, obesity had been stubbornly resistant to traditional public health approaches, and what this series tries to do is to look at the reasons why that might be and how we might get out of that public health 'cul-de-sac' that we are in today.”

The first article in the series (Lancet 2011;378:804-14) looks at the factors that might have contributed to the rising rates of obesity seen around the globe in the past 4 decades. As rates of obesity have risen steadily and simultaneously in many countries, “that points to global drivers,” said the paper's lead author Dr. Boyd Swinburn, professor of population health and the director of the World Health Organization Collaborating Centre for Obesity Prevention at Deakin University, Melbourne.

“There is quite a lot of evidence coming out that this is largely driven be changes in the food system,” which produces a food supply comprising “increasingly processed, available, affordable, and highly promoted, 'tasty' food,” Dr. Swinburn observed.

With both high- and low-income countries affected, the solution appears to lie more with policy changes to try to improve individuals' local environments rather than try to change the public's behavior.

“Support for individuals to counteract obesogenic environments will continue to be important, but the priority should be for policies to reverse the obesogenic nature,” Dr. Swinburn and his colleagues reported.

The lead author of the second article (Lancet 2011;378:815-25), Dr. Y. Claire Wang, noted that if historical trends continue, there could be 65 million more obese adults in the United States alone by 2030, with 11 million more obese adults projected at the same time point in the United Kingdom.

This would bring the total of obese individuals to be 164 million and 26 million, in each country, respectively and, taken together, could result in 6 million to 8.5 million new cases of diabetes, 5.7 million to 7.3 million cases of heart disease and stroke, and 492,000-669,000 additional cases of cancer in both countries.

“We project that the medical costs will be substantial,” said Dr. Wang, of the department of health policy and management at Columbia University, New York. Indeed, the cost of treating essential preventable diseases that result from obesity are estimated to increase by $48 billion to $66 billion per year in the United States and by £1.9 billion to £2 billion per/year in the United Kingdom by 2030.

However, a 1% reduction in body mass index across the U.S. population could avoid up to 2.1 million to 2.4 million new cases of diabetes, 1.4 million to 1.7 million cardiovascular diseases, and 73,000-127,000 cases of cancer by 2030. Similar reductions could be achieved in the United Kingdom.

“Of course, what we have to do is to reverse this [rising obesity trend],” said Kevin Hall, Ph.D., the lead author of the third article in the series (Lancet 2011;378; 826-37). But it may not be as simple as “eat less, exercise more” suggested Dr. Hall, a senior investigator at the National Institute of Diabetes and Digestive and Kidney Diseases.

Standard guidance for weight loss is to reduce caloric intake by 500-1,000 kcal/day to lose 1-2 pounds per week, but this is fundamentally wrong. “The reason it's wrong is that it would only be true if nothing else happened to your metabolism,” Dr. Hall maintained.

Dr. Hall's research shows that for every 10 calories that can be cut from the diet per day, there would more likely be a drop of just 1 pound over 3 years, so not eating a 250-calorie chocolate bar per day could would lead to a 25-pound weight loss over 3 years.

Dr. Hall presented a web-based model that could one day help clinicians advise their patients on how many calories would need to be cut from the diet and the level or exercise needed every day to attain a certain weight loss. Currently, the model can only be used as a research tool and will need to be updated as new data become available.

 

 

With all these new data and improved understanding of what causes obesity and its health care burden and costs, the lead author of the fourth and final article (Lancet 2011;378;838-47) in the series said that it's time for governments and policy makers to act.

“Governments certainly need to lead obesity prevention, but so far few have shown any leadership whatsoever,” commented Steven L. Gortmaker, Ph.D., of the department of society, human development, and health at Harvard School of Public Health in Boston.

Dr. Gortmaker and his colleagues noted that the U.N. meeting on noncommunicable diseases “is an important opportunity for the international community to provide the leadership, global standards, and cross-agency structures needed to create a global food system that offers a healthy and secure food supply for all.”

The research was conducted under the auspices of the Collaborative Obesity Modeling Network as part of the Envision Project and supported by the National Collaborative on Childhood Obesity Research, a collaboration of the National Institutes of Health, the Centers for Disease Control and Prevention, the United States Department of Agriculture, and the Robert Wood Johnson Foundation. The NIH and the NIDDK provided additional funding.

All authors declared that they had no conflicts of interest.

LONDON – The global obesity pandemic needs addressing on a global level with governments around the world taking the lead, according to a series of papers published in the Lancet.

The series is published ahead of the United Nations High-Level Meeting on Noncommunicable Diseases being held in New York next month. This U.N. meeting is set to discuss what can be done to prevent and control four key disease areas – cardiovascular diseases, cancers, chronic respiratory diseases, and diabetes – for which obesity is a known contributing or exacerbating factor.

“In many ways, the holy grail for governments today, certainly in the United Kingdom, across Europe and the United States, is improving health care while at the same time reducing costs; that's the paradox of modern health care today,” said Dr. Richard Horton, editor of The Lancet, during a press briefing to highlight the Lancet Obesity Series.

Dr. Horton added: “So far, obesity had been stubbornly resistant to traditional public health approaches, and what this series tries to do is to look at the reasons why that might be and how we might get out of that public health 'cul-de-sac' that we are in today.”

The first article in the series (Lancet 2011;378:804-14) looks at the factors that might have contributed to the rising rates of obesity seen around the globe in the past 4 decades. As rates of obesity have risen steadily and simultaneously in many countries, “that points to global drivers,” said the paper's lead author Dr. Boyd Swinburn, professor of population health and the director of the World Health Organization Collaborating Centre for Obesity Prevention at Deakin University, Melbourne.

“There is quite a lot of evidence coming out that this is largely driven be changes in the food system,” which produces a food supply comprising “increasingly processed, available, affordable, and highly promoted, 'tasty' food,” Dr. Swinburn observed.

With both high- and low-income countries affected, the solution appears to lie more with policy changes to try to improve individuals' local environments rather than try to change the public's behavior.

“Support for individuals to counteract obesogenic environments will continue to be important, but the priority should be for policies to reverse the obesogenic nature,” Dr. Swinburn and his colleagues reported.

The lead author of the second article (Lancet 2011;378:815-25), Dr. Y. Claire Wang, noted that if historical trends continue, there could be 65 million more obese adults in the United States alone by 2030, with 11 million more obese adults projected at the same time point in the United Kingdom.

This would bring the total of obese individuals to be 164 million and 26 million, in each country, respectively and, taken together, could result in 6 million to 8.5 million new cases of diabetes, 5.7 million to 7.3 million cases of heart disease and stroke, and 492,000-669,000 additional cases of cancer in both countries.

“We project that the medical costs will be substantial,” said Dr. Wang, of the department of health policy and management at Columbia University, New York. Indeed, the cost of treating essential preventable diseases that result from obesity are estimated to increase by $48 billion to $66 billion per year in the United States and by £1.9 billion to £2 billion per/year in the United Kingdom by 2030.

However, a 1% reduction in body mass index across the U.S. population could avoid up to 2.1 million to 2.4 million new cases of diabetes, 1.4 million to 1.7 million cardiovascular diseases, and 73,000-127,000 cases of cancer by 2030. Similar reductions could be achieved in the United Kingdom.

“Of course, what we have to do is to reverse this [rising obesity trend],” said Kevin Hall, Ph.D., the lead author of the third article in the series (Lancet 2011;378; 826-37). But it may not be as simple as “eat less, exercise more” suggested Dr. Hall, a senior investigator at the National Institute of Diabetes and Digestive and Kidney Diseases.

Standard guidance for weight loss is to reduce caloric intake by 500-1,000 kcal/day to lose 1-2 pounds per week, but this is fundamentally wrong. “The reason it's wrong is that it would only be true if nothing else happened to your metabolism,” Dr. Hall maintained.

Dr. Hall's research shows that for every 10 calories that can be cut from the diet per day, there would more likely be a drop of just 1 pound over 3 years, so not eating a 250-calorie chocolate bar per day could would lead to a 25-pound weight loss over 3 years.

Dr. Hall presented a web-based model that could one day help clinicians advise their patients on how many calories would need to be cut from the diet and the level or exercise needed every day to attain a certain weight loss. Currently, the model can only be used as a research tool and will need to be updated as new data become available.

 

 

With all these new data and improved understanding of what causes obesity and its health care burden and costs, the lead author of the fourth and final article (Lancet 2011;378;838-47) in the series said that it's time for governments and policy makers to act.

“Governments certainly need to lead obesity prevention, but so far few have shown any leadership whatsoever,” commented Steven L. Gortmaker, Ph.D., of the department of society, human development, and health at Harvard School of Public Health in Boston.

Dr. Gortmaker and his colleagues noted that the U.N. meeting on noncommunicable diseases “is an important opportunity for the international community to provide the leadership, global standards, and cross-agency structures needed to create a global food system that offers a healthy and secure food supply for all.”

The research was conducted under the auspices of the Collaborative Obesity Modeling Network as part of the Envision Project and supported by the National Collaborative on Childhood Obesity Research, a collaboration of the National Institutes of Health, the Centers for Disease Control and Prevention, the United States Department of Agriculture, and the Robert Wood Johnson Foundation. The NIH and the NIDDK provided additional funding.

All authors declared that they had no conflicts of interest.

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Major Finding: Odds ratios for the prescription of aspirin, a statin, and beta-blockers 30 days after a first MI were 0.75, 0.68, and 0.76, respectively.

Data Source: Danish registry study of 66,389 patients – 875 (1.3%) with RA – who had a first MI between 2002 and 2009.

Disclosures: Dr. Lindhardsen and Dr. Schett had no conflicts of interest to declare.

LONDON – Patients with rheumatoid arthritis who have had a heart attack for the first time do not appear to be getting medications recommended to prevent a further cardiovascular event, according to the findings of a large Danish study.

Aspirin, statins, and beta-blockers – cardioprotective medications that are given as the standard of care to most patients immediately following a myocardial infarction – were all less frequently prescribed to patients with rheumatoid arthritis (RA) than to members of the general patient population.

Indeed, 1 month after an MI, the odds ratios for the prescription of these drugs were 0.75 (95% confidence interval, 0.63-0.90) for aspirin, 0.68 (95% CI, 0.57-0.82) for a statin, and 0.76 (95% CI, 0.63-0.91) for beta-blockers. These results did not change greatly at follow-ups of 3 months, 6 months, or 1 year.

The increased risk of cardiovascular disease in RA is well known and could result from a number of causes, including the presence of classical risk factors such as dyslipidemia and hypertension, possible adverse effects of RA treatment, and an accelerated atherosclerotic process driven by the high levels of inflammation characteristic of the rheumatic disease.

“What's not been considered, [however,] and perhaps the simplest explanation, is whether or not there is undertreatment of [RA] patients,” Dr. Jesper Lindhardsen, of the cardiology department at Gentofte University Hospital, Copenhagen, said at a press briefing.

To determine whether patients with RA were being given standard cardioprotective medications after a first MI, he and his colleagues analyzed data from several Danish patient registries, including those giving prescription records, details of comorbidities, and income.

The study population consisted of 66,389 patients who had had a first heart attack between 2002 and 2009. Of these, 875 (1.3%) had RA. The median age was 72.6 years for RA patients and 69.4 years for patients without RA.

At baseline, the use of cardioprotective medications by patients with and without RA were relatively similar or the same, at 27% and 25.1%, respectively, for aspirin; 19.1% and 19.1% for a statin; 23.9% and 22.5% for a beta-blocker; and 3.3% and 2.2% for clopidogrel.

Although aspirin, statin, and beta-blocker use was later found to be lower in the RA patients than in the non-RA patients throughout the early post-MI period, there was no significant difference in the prescription of clopidogrel at 1, 3, or 6 months or at 1 year.

Commenting on the findings in an interview, Dr. Lindhardsen conceded that these data raise more questions than they answer. For one thing, it's not known what medications patients were taking before they had their heart attack, which could influence the findings.

Dr. Georg Schett, who is chief of rheumatology at the University of Erlangen-Nuremberg, Germany, but was not involved in the study, said the findings illustrate that the high cardiovascular risk in patients with RA is still not being taken seriously enough.

Speaking at a press conference, Dr. Schett said that “the risk of cardiovascular disease in RA is similar to diabetes, but people sometimes forget this.”

Indeed, Dr. Lindhardsen and his colleagues recently published data showing that RA is associated with the same risk of MI as diabetes (Ann. Rheum. Dis. 2011;70:929-34).

With regard to these post-MI data, Dr. Lindhardsen stressed the importance of communication between the cardiologist discharging a patient and the rheumatologist responsible for the patient's long-term care to ensure that standard cardioprotective medications are being used.

“We have quantitative data. Now we need more qualitative data,” Dr. Lindhardsen observed in an interview. The next steps are to try to determine the reasons RA patients get fewer prescriptions for these standard post-MI drugs, he said.

'The risk of cardiovascular disease in RA is similar to diabetes, but people sometimes forget this.'

Source DR. SCHETT

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Major Finding: Odds ratios for the prescription of aspirin, a statin, and beta-blockers 30 days after a first MI were 0.75, 0.68, and 0.76, respectively.

Data Source: Danish registry study of 66,389 patients – 875 (1.3%) with RA – who had a first MI between 2002 and 2009.

Disclosures: Dr. Lindhardsen and Dr. Schett had no conflicts of interest to declare.

LONDON – Patients with rheumatoid arthritis who have had a heart attack for the first time do not appear to be getting medications recommended to prevent a further cardiovascular event, according to the findings of a large Danish study.

Aspirin, statins, and beta-blockers – cardioprotective medications that are given as the standard of care to most patients immediately following a myocardial infarction – were all less frequently prescribed to patients with rheumatoid arthritis (RA) than to members of the general patient population.

Indeed, 1 month after an MI, the odds ratios for the prescription of these drugs were 0.75 (95% confidence interval, 0.63-0.90) for aspirin, 0.68 (95% CI, 0.57-0.82) for a statin, and 0.76 (95% CI, 0.63-0.91) for beta-blockers. These results did not change greatly at follow-ups of 3 months, 6 months, or 1 year.

The increased risk of cardiovascular disease in RA is well known and could result from a number of causes, including the presence of classical risk factors such as dyslipidemia and hypertension, possible adverse effects of RA treatment, and an accelerated atherosclerotic process driven by the high levels of inflammation characteristic of the rheumatic disease.

“What's not been considered, [however,] and perhaps the simplest explanation, is whether or not there is undertreatment of [RA] patients,” Dr. Jesper Lindhardsen, of the cardiology department at Gentofte University Hospital, Copenhagen, said at a press briefing.

To determine whether patients with RA were being given standard cardioprotective medications after a first MI, he and his colleagues analyzed data from several Danish patient registries, including those giving prescription records, details of comorbidities, and income.

The study population consisted of 66,389 patients who had had a first heart attack between 2002 and 2009. Of these, 875 (1.3%) had RA. The median age was 72.6 years for RA patients and 69.4 years for patients without RA.

At baseline, the use of cardioprotective medications by patients with and without RA were relatively similar or the same, at 27% and 25.1%, respectively, for aspirin; 19.1% and 19.1% for a statin; 23.9% and 22.5% for a beta-blocker; and 3.3% and 2.2% for clopidogrel.

Although aspirin, statin, and beta-blocker use was later found to be lower in the RA patients than in the non-RA patients throughout the early post-MI period, there was no significant difference in the prescription of clopidogrel at 1, 3, or 6 months or at 1 year.

Commenting on the findings in an interview, Dr. Lindhardsen conceded that these data raise more questions than they answer. For one thing, it's not known what medications patients were taking before they had their heart attack, which could influence the findings.

Dr. Georg Schett, who is chief of rheumatology at the University of Erlangen-Nuremberg, Germany, but was not involved in the study, said the findings illustrate that the high cardiovascular risk in patients with RA is still not being taken seriously enough.

Speaking at a press conference, Dr. Schett said that “the risk of cardiovascular disease in RA is similar to diabetes, but people sometimes forget this.”

Indeed, Dr. Lindhardsen and his colleagues recently published data showing that RA is associated with the same risk of MI as diabetes (Ann. Rheum. Dis. 2011;70:929-34).

With regard to these post-MI data, Dr. Lindhardsen stressed the importance of communication between the cardiologist discharging a patient and the rheumatologist responsible for the patient's long-term care to ensure that standard cardioprotective medications are being used.

“We have quantitative data. Now we need more qualitative data,” Dr. Lindhardsen observed in an interview. The next steps are to try to determine the reasons RA patients get fewer prescriptions for these standard post-MI drugs, he said.

'The risk of cardiovascular disease in RA is similar to diabetes, but people sometimes forget this.'

Source DR. SCHETT

Major Finding: Odds ratios for the prescription of aspirin, a statin, and beta-blockers 30 days after a first MI were 0.75, 0.68, and 0.76, respectively.

Data Source: Danish registry study of 66,389 patients – 875 (1.3%) with RA – who had a first MI between 2002 and 2009.

Disclosures: Dr. Lindhardsen and Dr. Schett had no conflicts of interest to declare.

LONDON – Patients with rheumatoid arthritis who have had a heart attack for the first time do not appear to be getting medications recommended to prevent a further cardiovascular event, according to the findings of a large Danish study.

Aspirin, statins, and beta-blockers – cardioprotective medications that are given as the standard of care to most patients immediately following a myocardial infarction – were all less frequently prescribed to patients with rheumatoid arthritis (RA) than to members of the general patient population.

Indeed, 1 month after an MI, the odds ratios for the prescription of these drugs were 0.75 (95% confidence interval, 0.63-0.90) for aspirin, 0.68 (95% CI, 0.57-0.82) for a statin, and 0.76 (95% CI, 0.63-0.91) for beta-blockers. These results did not change greatly at follow-ups of 3 months, 6 months, or 1 year.

The increased risk of cardiovascular disease in RA is well known and could result from a number of causes, including the presence of classical risk factors such as dyslipidemia and hypertension, possible adverse effects of RA treatment, and an accelerated atherosclerotic process driven by the high levels of inflammation characteristic of the rheumatic disease.

“What's not been considered, [however,] and perhaps the simplest explanation, is whether or not there is undertreatment of [RA] patients,” Dr. Jesper Lindhardsen, of the cardiology department at Gentofte University Hospital, Copenhagen, said at a press briefing.

To determine whether patients with RA were being given standard cardioprotective medications after a first MI, he and his colleagues analyzed data from several Danish patient registries, including those giving prescription records, details of comorbidities, and income.

The study population consisted of 66,389 patients who had had a first heart attack between 2002 and 2009. Of these, 875 (1.3%) had RA. The median age was 72.6 years for RA patients and 69.4 years for patients without RA.

At baseline, the use of cardioprotective medications by patients with and without RA were relatively similar or the same, at 27% and 25.1%, respectively, for aspirin; 19.1% and 19.1% for a statin; 23.9% and 22.5% for a beta-blocker; and 3.3% and 2.2% for clopidogrel.

Although aspirin, statin, and beta-blocker use was later found to be lower in the RA patients than in the non-RA patients throughout the early post-MI period, there was no significant difference in the prescription of clopidogrel at 1, 3, or 6 months or at 1 year.

Commenting on the findings in an interview, Dr. Lindhardsen conceded that these data raise more questions than they answer. For one thing, it's not known what medications patients were taking before they had their heart attack, which could influence the findings.

Dr. Georg Schett, who is chief of rheumatology at the University of Erlangen-Nuremberg, Germany, but was not involved in the study, said the findings illustrate that the high cardiovascular risk in patients with RA is still not being taken seriously enough.

Speaking at a press conference, Dr. Schett said that “the risk of cardiovascular disease in RA is similar to diabetes, but people sometimes forget this.”

Indeed, Dr. Lindhardsen and his colleagues recently published data showing that RA is associated with the same risk of MI as diabetes (Ann. Rheum. Dis. 2011;70:929-34).

With regard to these post-MI data, Dr. Lindhardsen stressed the importance of communication between the cardiologist discharging a patient and the rheumatologist responsible for the patient's long-term care to ensure that standard cardioprotective medications are being used.

“We have quantitative data. Now we need more qualitative data,” Dr. Lindhardsen observed in an interview. The next steps are to try to determine the reasons RA patients get fewer prescriptions for these standard post-MI drugs, he said.

'The risk of cardiovascular disease in RA is similar to diabetes, but people sometimes forget this.'

Source DR. SCHETT

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Global Change Needed to Stem Obesity Pandemic

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LONDON – The global obesity pandemic needs addressing on a global level with governments around the world taking the lead, according to a series of papers published Aug. 26 in the Lancet.

The series is published ahead of the United Nations High-Level Meeting on Noncommunicable Diseases being held in New York next month. This U.N. meeting is set to discuss what can be done to prevent and control four key disease areas – cardiovascular diseases, cancers, chronic respiratory diseases, and diabetes – for which obesity is a known contributing or exacerbating factor.

"In many ways, the holy grail for governments today, certainly in the United Kingdom, across Europe and the United States, is improving health care while at the same time reducing costs; that’s the paradox of modern health care today," said Dr. Richard Horton, editor of the Lancet, during a press briefing to highlight the Lancet Obesity Series.

Dr. Horton added: "So far, obesity had been stubbornly resistant to traditional public health approaches, and what this series tries to do is to look at the reasons why that might be and how we might get out of that public health ‘cul-de-sac’ that we are in today."

The first article in the series (Lancet 2011;378:804-14) looks at the factors that might have contributed to the rising rates of obesity seen around the globe in the past 4 decades. As rates of obesity have risen steadily and simultaneously in many countries, "that points to global drivers," said the paper’s lead author Dr. Boyd Swinburn, professor of population health and the director of the World Health Organization Collaborating Centre for Obesity Prevention at Deakin University, Melbourne.

"There is quite a lot of evidence coming out that this is largely driven be changes in the food system," which produces a food supply comprising "increasingly processed, available, affordable, and highly promoted, ‘tasty’ food," Dr. Swinburn observed.

With both high- and low-income countries affected, the solution appears to lie more with policy changes to try to improve individuals’ local environments rather than try to change the public’s behavior.

"Support for individuals to counteract obesogenic environments will continue to be important, but the priority should be for policies to reverse the obesogenic nature," Dr. Swinburn and his colleagues reported.

The lead author of the second article (Lancet 2011;378:815-25), Dr. Y. Claire Wang, noted that if historical trends continue, there could be 65 million more obese adults in the United States alone by 2030, with 11 million more obese adults projected at the same time point in the United Kingdom.

This would bring the total of obese individuals to be 164 million and 26 million, in each country respectively and, taken together, could result in 6 million to 8.5 million new cases of diabetes, 5.7 million to 7.3 million cases of heart disease and stroke, and 492,000-669,000 additional cases of cancer in both countries.

"We project that the medical costs will be substantial," said Dr. Wang of the department of health policy and management at Columbia University, New York. Indeed, the cost of treating essential preventable diseases that result from obesity are estimated to increase by $48 billion to 66 billion/year in the United States and by £1·9 billion to 2 billion/year in the United Kingdom by 2030.

However, a 1% reduction in body mass index across the U.S. population could avoid up to 2.1 million to 2.4 million new cases of diabetes, 1.4 million to 1.7 million cardiovascular diseases, and 73,000-127,000 cases of cancer by 2030. Similar reductions could be achieved in the United Kingdom.

"Of course, what we have to do is to reverse this [rising obesity trend]," said Kevin Hall, Ph.D., the lead author of the third article in the series (Lancet 2011;378;826-37). But it may not be as simple as "eat less, exercise more" suggested Dr. Hall, a senior investigator at the National Institute of Diabetes and Digestive and Kidney Diseases.

Standard guidance for weight loss is to reduce caloric intake by 500-1,000 kcal/day to lose 1-2 pounds per week, but this is fundamentally wrong. "The reason it’s wrong is that it would only be true if nothing else happened to your metabolism," Dr. Hall maintained.

Dr. Hall’s research shows that for every 10 calories that can be cut from the diet per day, there would more likely be a drop of just 1 pound over 3 years, so not eating a 250-calorie chocolate bar per day could would lead to a 25-pound weight loss over 3 years.

Dr. Hall presented a Web-based model that could one day help clinicians advise their patients on how many calories would need to be cut from the diet and the level or exercise needed every day to attain a certain weight loss. Currently, the model can only be used as a research tool and will need to be updated as new data become available.

 

 

With all this new data and improved understanding of what causes obesity and its health care burden and costs, the lead author of the fourth and final article (Lancet 2011;378;838-47) in the series said that it’s time for governments and policy makers to act.

"Governments certainly need to lead obesity prevention, but so far few have shown any leadership whatsoever," commented Steven L. Gortmaker, Ph.D., of the department of society, human development, and health at Harvard School of Public Health in Boston.

Dr. Gortmaker and his colleagues noted that the U.N. meeting on noncommunicable diseases "is an important opportunity for the international community to provide the leadership, global standards, and cross-agency structures needed to create a global food system that offers a healthy and secure food supply for all."

The research was conducted under the auspices of the Collaborative Obesity Modeling Network as part of the Envision Project and supported by the National Collaborative on Childhood Obesity Research, a collaboration of the National Institutes of Health, the Centers for Disease Control and Prevention, the United States Department of Agriculture, and the Robert Wood Johnson Foundation. The NIH and the NIDDK provided additional funding.

All authors declared that they had no conflicts of interest.

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LONDON – The global obesity pandemic needs addressing on a global level with governments around the world taking the lead, according to a series of papers published Aug. 26 in the Lancet.

The series is published ahead of the United Nations High-Level Meeting on Noncommunicable Diseases being held in New York next month. This U.N. meeting is set to discuss what can be done to prevent and control four key disease areas – cardiovascular diseases, cancers, chronic respiratory diseases, and diabetes – for which obesity is a known contributing or exacerbating factor.

"In many ways, the holy grail for governments today, certainly in the United Kingdom, across Europe and the United States, is improving health care while at the same time reducing costs; that’s the paradox of modern health care today," said Dr. Richard Horton, editor of the Lancet, during a press briefing to highlight the Lancet Obesity Series.

Dr. Horton added: "So far, obesity had been stubbornly resistant to traditional public health approaches, and what this series tries to do is to look at the reasons why that might be and how we might get out of that public health ‘cul-de-sac’ that we are in today."

The first article in the series (Lancet 2011;378:804-14) looks at the factors that might have contributed to the rising rates of obesity seen around the globe in the past 4 decades. As rates of obesity have risen steadily and simultaneously in many countries, "that points to global drivers," said the paper’s lead author Dr. Boyd Swinburn, professor of population health and the director of the World Health Organization Collaborating Centre for Obesity Prevention at Deakin University, Melbourne.

"There is quite a lot of evidence coming out that this is largely driven be changes in the food system," which produces a food supply comprising "increasingly processed, available, affordable, and highly promoted, ‘tasty’ food," Dr. Swinburn observed.

With both high- and low-income countries affected, the solution appears to lie more with policy changes to try to improve individuals’ local environments rather than try to change the public’s behavior.

"Support for individuals to counteract obesogenic environments will continue to be important, but the priority should be for policies to reverse the obesogenic nature," Dr. Swinburn and his colleagues reported.

The lead author of the second article (Lancet 2011;378:815-25), Dr. Y. Claire Wang, noted that if historical trends continue, there could be 65 million more obese adults in the United States alone by 2030, with 11 million more obese adults projected at the same time point in the United Kingdom.

This would bring the total of obese individuals to be 164 million and 26 million, in each country respectively and, taken together, could result in 6 million to 8.5 million new cases of diabetes, 5.7 million to 7.3 million cases of heart disease and stroke, and 492,000-669,000 additional cases of cancer in both countries.

"We project that the medical costs will be substantial," said Dr. Wang of the department of health policy and management at Columbia University, New York. Indeed, the cost of treating essential preventable diseases that result from obesity are estimated to increase by $48 billion to 66 billion/year in the United States and by £1·9 billion to 2 billion/year in the United Kingdom by 2030.

However, a 1% reduction in body mass index across the U.S. population could avoid up to 2.1 million to 2.4 million new cases of diabetes, 1.4 million to 1.7 million cardiovascular diseases, and 73,000-127,000 cases of cancer by 2030. Similar reductions could be achieved in the United Kingdom.

"Of course, what we have to do is to reverse this [rising obesity trend]," said Kevin Hall, Ph.D., the lead author of the third article in the series (Lancet 2011;378;826-37). But it may not be as simple as "eat less, exercise more" suggested Dr. Hall, a senior investigator at the National Institute of Diabetes and Digestive and Kidney Diseases.

Standard guidance for weight loss is to reduce caloric intake by 500-1,000 kcal/day to lose 1-2 pounds per week, but this is fundamentally wrong. "The reason it’s wrong is that it would only be true if nothing else happened to your metabolism," Dr. Hall maintained.

Dr. Hall’s research shows that for every 10 calories that can be cut from the diet per day, there would more likely be a drop of just 1 pound over 3 years, so not eating a 250-calorie chocolate bar per day could would lead to a 25-pound weight loss over 3 years.

Dr. Hall presented a Web-based model that could one day help clinicians advise their patients on how many calories would need to be cut from the diet and the level or exercise needed every day to attain a certain weight loss. Currently, the model can only be used as a research tool and will need to be updated as new data become available.

 

 

With all this new data and improved understanding of what causes obesity and its health care burden and costs, the lead author of the fourth and final article (Lancet 2011;378;838-47) in the series said that it’s time for governments and policy makers to act.

"Governments certainly need to lead obesity prevention, but so far few have shown any leadership whatsoever," commented Steven L. Gortmaker, Ph.D., of the department of society, human development, and health at Harvard School of Public Health in Boston.

Dr. Gortmaker and his colleagues noted that the U.N. meeting on noncommunicable diseases "is an important opportunity for the international community to provide the leadership, global standards, and cross-agency structures needed to create a global food system that offers a healthy and secure food supply for all."

The research was conducted under the auspices of the Collaborative Obesity Modeling Network as part of the Envision Project and supported by the National Collaborative on Childhood Obesity Research, a collaboration of the National Institutes of Health, the Centers for Disease Control and Prevention, the United States Department of Agriculture, and the Robert Wood Johnson Foundation. The NIH and the NIDDK provided additional funding.

All authors declared that they had no conflicts of interest.

LONDON – The global obesity pandemic needs addressing on a global level with governments around the world taking the lead, according to a series of papers published Aug. 26 in the Lancet.

The series is published ahead of the United Nations High-Level Meeting on Noncommunicable Diseases being held in New York next month. This U.N. meeting is set to discuss what can be done to prevent and control four key disease areas – cardiovascular diseases, cancers, chronic respiratory diseases, and diabetes – for which obesity is a known contributing or exacerbating factor.

"In many ways, the holy grail for governments today, certainly in the United Kingdom, across Europe and the United States, is improving health care while at the same time reducing costs; that’s the paradox of modern health care today," said Dr. Richard Horton, editor of the Lancet, during a press briefing to highlight the Lancet Obesity Series.

Dr. Horton added: "So far, obesity had been stubbornly resistant to traditional public health approaches, and what this series tries to do is to look at the reasons why that might be and how we might get out of that public health ‘cul-de-sac’ that we are in today."

The first article in the series (Lancet 2011;378:804-14) looks at the factors that might have contributed to the rising rates of obesity seen around the globe in the past 4 decades. As rates of obesity have risen steadily and simultaneously in many countries, "that points to global drivers," said the paper’s lead author Dr. Boyd Swinburn, professor of population health and the director of the World Health Organization Collaborating Centre for Obesity Prevention at Deakin University, Melbourne.

"There is quite a lot of evidence coming out that this is largely driven be changes in the food system," which produces a food supply comprising "increasingly processed, available, affordable, and highly promoted, ‘tasty’ food," Dr. Swinburn observed.

With both high- and low-income countries affected, the solution appears to lie more with policy changes to try to improve individuals’ local environments rather than try to change the public’s behavior.

"Support for individuals to counteract obesogenic environments will continue to be important, but the priority should be for policies to reverse the obesogenic nature," Dr. Swinburn and his colleagues reported.

The lead author of the second article (Lancet 2011;378:815-25), Dr. Y. Claire Wang, noted that if historical trends continue, there could be 65 million more obese adults in the United States alone by 2030, with 11 million more obese adults projected at the same time point in the United Kingdom.

This would bring the total of obese individuals to be 164 million and 26 million, in each country respectively and, taken together, could result in 6 million to 8.5 million new cases of diabetes, 5.7 million to 7.3 million cases of heart disease and stroke, and 492,000-669,000 additional cases of cancer in both countries.

"We project that the medical costs will be substantial," said Dr. Wang of the department of health policy and management at Columbia University, New York. Indeed, the cost of treating essential preventable diseases that result from obesity are estimated to increase by $48 billion to 66 billion/year in the United States and by £1·9 billion to 2 billion/year in the United Kingdom by 2030.

However, a 1% reduction in body mass index across the U.S. population could avoid up to 2.1 million to 2.4 million new cases of diabetes, 1.4 million to 1.7 million cardiovascular diseases, and 73,000-127,000 cases of cancer by 2030. Similar reductions could be achieved in the United Kingdom.

"Of course, what we have to do is to reverse this [rising obesity trend]," said Kevin Hall, Ph.D., the lead author of the third article in the series (Lancet 2011;378;826-37). But it may not be as simple as "eat less, exercise more" suggested Dr. Hall, a senior investigator at the National Institute of Diabetes and Digestive and Kidney Diseases.

Standard guidance for weight loss is to reduce caloric intake by 500-1,000 kcal/day to lose 1-2 pounds per week, but this is fundamentally wrong. "The reason it’s wrong is that it would only be true if nothing else happened to your metabolism," Dr. Hall maintained.

Dr. Hall’s research shows that for every 10 calories that can be cut from the diet per day, there would more likely be a drop of just 1 pound over 3 years, so not eating a 250-calorie chocolate bar per day could would lead to a 25-pound weight loss over 3 years.

Dr. Hall presented a Web-based model that could one day help clinicians advise their patients on how many calories would need to be cut from the diet and the level or exercise needed every day to attain a certain weight loss. Currently, the model can only be used as a research tool and will need to be updated as new data become available.

 

 

With all this new data and improved understanding of what causes obesity and its health care burden and costs, the lead author of the fourth and final article (Lancet 2011;378;838-47) in the series said that it’s time for governments and policy makers to act.

"Governments certainly need to lead obesity prevention, but so far few have shown any leadership whatsoever," commented Steven L. Gortmaker, Ph.D., of the department of society, human development, and health at Harvard School of Public Health in Boston.

Dr. Gortmaker and his colleagues noted that the U.N. meeting on noncommunicable diseases "is an important opportunity for the international community to provide the leadership, global standards, and cross-agency structures needed to create a global food system that offers a healthy and secure food supply for all."

The research was conducted under the auspices of the Collaborative Obesity Modeling Network as part of the Envision Project and supported by the National Collaborative on Childhood Obesity Research, a collaboration of the National Institutes of Health, the Centers for Disease Control and Prevention, the United States Department of Agriculture, and the Robert Wood Johnson Foundation. The NIH and the NIDDK provided additional funding.

All authors declared that they had no conflicts of interest.

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COPD Prevalence Is Doubled With Rheumatoid Arthritis

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Major Finding: COPD was a comorbid condition in 8.9% of patients with RA compared with 4.4% of controls from the general population in one study (P less than .001), with 7.3% of the Norfolk Arthritis Register study population also found to have the respiratory disease.

Data Source: A case-control study of more than 30,000 individuals with or without rheumatoid arthritis and data from a 15-year follow up of 435 patients with inflammatory polyarthritis or RA in the Norfolk Arthritis Register.

Disclosures: NOAR is funded by Arthritis Research UK. Dr. Verstappen and Dr. Amital and colleagues had no conflicts of interest to declare.

LONDON – Patients with rheumatoid arthritis have a high risk of concomitant chronic obstructive pulmonary disease, according to data from two studies.

In one of the studies – which involved more than 15,000 patients with rheumatoid arthritis (RA) and 15,000 healthy individuals as case-matched controls – the risk of the long-term lung condition was 8.9% and 4.4%, respectively (P less than .001).

Other data, from the Norfolk Arthritis Register (NOAR) showed that the prevalence of chronic obstructive pulmonary disease (COPD) in patients with inflammatory polyarthritis (IP) or RA was 7.3% (n = 425) at 15 years' follow-up. Prevalence of the respiratory disease was again doubled when compared to the general population.

“Lung involvement is a common extra-articular manifestation in rheumatoid arthritis,” said Dr. Suzanne Verstappen, who presented the findings from the NOAR at the congress.

“As could be expected, age and gender were associated with obstructive and restrictive lung disease,” said Dr. Verstappen, a research fellow at the Arthritis Research UK Epidemiology Unit at the University of Manchester, England, where the NOAR is coordinated.

Validated spirometry parameters and the Medical Research Council respiratory symptoms questionnaire were used to identify patients with IP or RA who also had COPD. The latter was distinguished from restrictive lung disease. The prevalence of restrictive lung disease was 9.7%.

COPD was observed in 7.3% of the population at 15 years, with higher prevalence rates found in men versus women over the age of 45 years (12.7% vs. 6%, respectively) in a crude comparison.

Published rates for the U.K. general population without IP or RA are 6.8% and 3.9% (Popul. Health Metr. 2007;5:8).

Like RA, COPD is a chronic and often debilitating disease. The disease manifests later in life and treatment is symptomatic rather than curative, as the obstruction in the airways is permanent and not usually reversible with bronchodilator therapy.

Unlike RA, however, which has multiple etiologic factors and autoimmunity at its root, COPD is almost always caused by smoking.

In the NOAR analysis, 53% of the 425 patients were ex-smokers and 13% were current smokers; 34% had never smoked.

Data from the first study, presented during a poster session by Dr. Howard Amital of Sheba Medical Centre in Tel Hashomer, Israel, showed, however, that even with smoking out of the equation, the risk of COPD in patients with RA was higher than in the general population.

Indeed, multivariate analysis demonstrated that RA was associated with COPD after the researchers controlled for confounding factors such as age, gender, smoking, obesity, and socioeconomic status.

“The strength of the association increased,” Dr. Amital and colleagues reported, with an adjusted odds ratio of 2.015 (95% confidence interval 1.83-2.22; P less than .001) and an unadjusted OR of 1.89 (95% CI 1.74-2.05, P less than .0001).

The case-control study involved 15,766 patients with RA and 15,240 age- and sex-matched healthy individuals without RA.

The study also found higher rates of other chronic disease in patients versus controls, including diabetes (23.9% vs. 19.8%, P less than .0001), ischemic heart disease (19.5% vs. 15.4%, P less than .0001), and heart failure (6.3% vs. 4.3%, P less than .0001).

“This study corroborates the hypothesis that COPD and RA are closely interrelated,” Dr. Amital and his team concluded.

This frontal view of the chest shows chronic obstructive pulmonary disease.

Source ©Living Art Enterprises, LLC/Photo Researchers, Inc.

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Major Finding: COPD was a comorbid condition in 8.9% of patients with RA compared with 4.4% of controls from the general population in one study (P less than .001), with 7.3% of the Norfolk Arthritis Register study population also found to have the respiratory disease.

Data Source: A case-control study of more than 30,000 individuals with or without rheumatoid arthritis and data from a 15-year follow up of 435 patients with inflammatory polyarthritis or RA in the Norfolk Arthritis Register.

Disclosures: NOAR is funded by Arthritis Research UK. Dr. Verstappen and Dr. Amital and colleagues had no conflicts of interest to declare.

LONDON – Patients with rheumatoid arthritis have a high risk of concomitant chronic obstructive pulmonary disease, according to data from two studies.

In one of the studies – which involved more than 15,000 patients with rheumatoid arthritis (RA) and 15,000 healthy individuals as case-matched controls – the risk of the long-term lung condition was 8.9% and 4.4%, respectively (P less than .001).

Other data, from the Norfolk Arthritis Register (NOAR) showed that the prevalence of chronic obstructive pulmonary disease (COPD) in patients with inflammatory polyarthritis (IP) or RA was 7.3% (n = 425) at 15 years' follow-up. Prevalence of the respiratory disease was again doubled when compared to the general population.

“Lung involvement is a common extra-articular manifestation in rheumatoid arthritis,” said Dr. Suzanne Verstappen, who presented the findings from the NOAR at the congress.

“As could be expected, age and gender were associated with obstructive and restrictive lung disease,” said Dr. Verstappen, a research fellow at the Arthritis Research UK Epidemiology Unit at the University of Manchester, England, where the NOAR is coordinated.

Validated spirometry parameters and the Medical Research Council respiratory symptoms questionnaire were used to identify patients with IP or RA who also had COPD. The latter was distinguished from restrictive lung disease. The prevalence of restrictive lung disease was 9.7%.

COPD was observed in 7.3% of the population at 15 years, with higher prevalence rates found in men versus women over the age of 45 years (12.7% vs. 6%, respectively) in a crude comparison.

Published rates for the U.K. general population without IP or RA are 6.8% and 3.9% (Popul. Health Metr. 2007;5:8).

Like RA, COPD is a chronic and often debilitating disease. The disease manifests later in life and treatment is symptomatic rather than curative, as the obstruction in the airways is permanent and not usually reversible with bronchodilator therapy.

Unlike RA, however, which has multiple etiologic factors and autoimmunity at its root, COPD is almost always caused by smoking.

In the NOAR analysis, 53% of the 425 patients were ex-smokers and 13% were current smokers; 34% had never smoked.

Data from the first study, presented during a poster session by Dr. Howard Amital of Sheba Medical Centre in Tel Hashomer, Israel, showed, however, that even with smoking out of the equation, the risk of COPD in patients with RA was higher than in the general population.

Indeed, multivariate analysis demonstrated that RA was associated with COPD after the researchers controlled for confounding factors such as age, gender, smoking, obesity, and socioeconomic status.

“The strength of the association increased,” Dr. Amital and colleagues reported, with an adjusted odds ratio of 2.015 (95% confidence interval 1.83-2.22; P less than .001) and an unadjusted OR of 1.89 (95% CI 1.74-2.05, P less than .0001).

The case-control study involved 15,766 patients with RA and 15,240 age- and sex-matched healthy individuals without RA.

The study also found higher rates of other chronic disease in patients versus controls, including diabetes (23.9% vs. 19.8%, P less than .0001), ischemic heart disease (19.5% vs. 15.4%, P less than .0001), and heart failure (6.3% vs. 4.3%, P less than .0001).

“This study corroborates the hypothesis that COPD and RA are closely interrelated,” Dr. Amital and his team concluded.

This frontal view of the chest shows chronic obstructive pulmonary disease.

Source ©Living Art Enterprises, LLC/Photo Researchers, Inc.

Major Finding: COPD was a comorbid condition in 8.9% of patients with RA compared with 4.4% of controls from the general population in one study (P less than .001), with 7.3% of the Norfolk Arthritis Register study population also found to have the respiratory disease.

Data Source: A case-control study of more than 30,000 individuals with or without rheumatoid arthritis and data from a 15-year follow up of 435 patients with inflammatory polyarthritis or RA in the Norfolk Arthritis Register.

Disclosures: NOAR is funded by Arthritis Research UK. Dr. Verstappen and Dr. Amital and colleagues had no conflicts of interest to declare.

LONDON – Patients with rheumatoid arthritis have a high risk of concomitant chronic obstructive pulmonary disease, according to data from two studies.

In one of the studies – which involved more than 15,000 patients with rheumatoid arthritis (RA) and 15,000 healthy individuals as case-matched controls – the risk of the long-term lung condition was 8.9% and 4.4%, respectively (P less than .001).

Other data, from the Norfolk Arthritis Register (NOAR) showed that the prevalence of chronic obstructive pulmonary disease (COPD) in patients with inflammatory polyarthritis (IP) or RA was 7.3% (n = 425) at 15 years' follow-up. Prevalence of the respiratory disease was again doubled when compared to the general population.

“Lung involvement is a common extra-articular manifestation in rheumatoid arthritis,” said Dr. Suzanne Verstappen, who presented the findings from the NOAR at the congress.

“As could be expected, age and gender were associated with obstructive and restrictive lung disease,” said Dr. Verstappen, a research fellow at the Arthritis Research UK Epidemiology Unit at the University of Manchester, England, where the NOAR is coordinated.

Validated spirometry parameters and the Medical Research Council respiratory symptoms questionnaire were used to identify patients with IP or RA who also had COPD. The latter was distinguished from restrictive lung disease. The prevalence of restrictive lung disease was 9.7%.

COPD was observed in 7.3% of the population at 15 years, with higher prevalence rates found in men versus women over the age of 45 years (12.7% vs. 6%, respectively) in a crude comparison.

Published rates for the U.K. general population without IP or RA are 6.8% and 3.9% (Popul. Health Metr. 2007;5:8).

Like RA, COPD is a chronic and often debilitating disease. The disease manifests later in life and treatment is symptomatic rather than curative, as the obstruction in the airways is permanent and not usually reversible with bronchodilator therapy.

Unlike RA, however, which has multiple etiologic factors and autoimmunity at its root, COPD is almost always caused by smoking.

In the NOAR analysis, 53% of the 425 patients were ex-smokers and 13% were current smokers; 34% had never smoked.

Data from the first study, presented during a poster session by Dr. Howard Amital of Sheba Medical Centre in Tel Hashomer, Israel, showed, however, that even with smoking out of the equation, the risk of COPD in patients with RA was higher than in the general population.

Indeed, multivariate analysis demonstrated that RA was associated with COPD after the researchers controlled for confounding factors such as age, gender, smoking, obesity, and socioeconomic status.

“The strength of the association increased,” Dr. Amital and colleagues reported, with an adjusted odds ratio of 2.015 (95% confidence interval 1.83-2.22; P less than .001) and an unadjusted OR of 1.89 (95% CI 1.74-2.05, P less than .0001).

The case-control study involved 15,766 patients with RA and 15,240 age- and sex-matched healthy individuals without RA.

The study also found higher rates of other chronic disease in patients versus controls, including diabetes (23.9% vs. 19.8%, P less than .0001), ischemic heart disease (19.5% vs. 15.4%, P less than .0001), and heart failure (6.3% vs. 4.3%, P less than .0001).

“This study corroborates the hypothesis that COPD and RA are closely interrelated,” Dr. Amital and his team concluded.

This frontal view of the chest shows chronic obstructive pulmonary disease.

Source ©Living Art Enterprises, LLC/Photo Researchers, Inc.

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HLA-B27 Predicts TNF-Inhibitor Response : Costly agents reduce symptoms of AS, but not everyone benefits.

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HLA-B27 Predicts TNF-Inhibitor Response : Costly agents reduce symptoms of AS, but not everyone benefits.

Major Finding: The odds ratio for patients who were HLA-B27 positive and achieved ASDAS major improvement (greater than or equal to 2.0) at 3 months was 6.72, compared with those who were not (95% CI, 1.33-33.87; P = .02).

Data Source: Longitudinal, observational study of 171 patients with AS who were treated with an anti-TNF agent for the first time and were enrolled in NOR-DMARD, a register of adult patients with inflammatory arthropathies who were treated at five rheumatology centers in Norway.

Disclosures: Dr. Fagerli disclosed receiving a speaker's fee from Pfizer in the past.

LONDON – In the everyday setting, HLA-B27 positivity is the strongest predictor of an early, good response to the first use of an anti–tumor necrosis factor agent in patients with ankylosing spondylitis, according to the results of a longitudinal, observational study.

Other “real-world” and independent predictors of a good response using the ankylosing spondylitis disease activity score (ASDAS) are younger age, male sex, a higher baseline C-reactive protein (CRP) level, and a higher baseline patient global assessment score.

“TNF [tumor necrosis factor] inhibitors are effective in reducing symptoms in ankylosing spondylitis [AS], but not all patients have a response, and [they] sometimes have side effects, and the medication is expensive,” said Karen Fagerli, Ph.D., of the department of rheumatology at Diakonhjemmet Hospital in Oslo.

“So we want to identify characteristics of patients who will have a response in order to potentially utilize this knowledge when selecting patients for TNF-inhibitor therapy, and [therefore] treat patients with an optimized benefit-to-risk ratio,” Dr. Fagerli added. ASDAS was used as the main outcome measure, which may be the first time it has been used in an observational study setting.

Using data from the NOR-DMARD (Norway–Disease-Modifying Antirheumatic Drug) register, researchers identified a study population of 171 patients with AS who were starting a TNF inhibitor for the first time.

NOR-DMARD is a large, observational register that includes all patients with inflammatory arthropathies who are starting treatment with a DMARD for the first time at five rheumatology centers in Norway. Patients are routinely assessed at baseline, then after 3, 6, and 12 months, and then annually.

ASDAS major improvement was defined as a change in score of 2 or more; this was achieved by 32.7% of patients after 3 months of anti-TNF therapy.

Several parameters that had been identified as predictors of response in univariate analysis did not hold up as being statistically significant in a multivariate analysis model; these included the number of swollen joints, physician's global score, the Bath Ankylosing Spondylitis Disease Activity Index (BASDAI), and the Bath Ankylosing Spondylitis Functional Activity Index (BASFAI)

Patients who were HLA-B27 positive had a much higher chance of achieving ASDAS major improvement at 3 months than did those who were HLA-B27 negative (odds ratio, 6.72; 95% confidence interval, 1.33-33.87; P = .02).

Baseline CRP levels higher than 10 mg/L were also significantly predictive of an early treatment response (OR, 5.31; 95% CI, 2.23-12.42; P less than .001).

The next strongest predictor was male sex, with men almost three times more likely than women to show a benefit of anti-TNF treatment at 3 months (OR, 2.69; 95% CI, 1.04-7.00; P less than .04). However, the majority of the study population (73.4%) was male.

For every 1-year increase in age, the likelihood of achieving ASDAS major improvement declined, with young patients faring the best overall (OR, 0.95; 95% CI, 0.91-1.00; P less than .03). Furthermore, for every 10-mm increase in a 0- to 100-mm visual analog scale of patient global assessment, the chance of a good response improved (OR, 1.75; 95% CI, 1.40-2.19; P less than .0001).

Taken together, these data could help clinicians to identify patients who not only may respond to anti-TNF inhibitors but also should be prioritized for such treatment. However, “this is on a crude level; we don't know to what extent we can use [this information] on an individual level,” Dr. Fagerli said in an interview.

“We know for certain that there are patients who have none of these characteristics that I've talked about, who do get a response, so this is not the full truth; this is a little piece of the puzzle.”

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Major Finding: The odds ratio for patients who were HLA-B27 positive and achieved ASDAS major improvement (greater than or equal to 2.0) at 3 months was 6.72, compared with those who were not (95% CI, 1.33-33.87; P = .02).

Data Source: Longitudinal, observational study of 171 patients with AS who were treated with an anti-TNF agent for the first time and were enrolled in NOR-DMARD, a register of adult patients with inflammatory arthropathies who were treated at five rheumatology centers in Norway.

Disclosures: Dr. Fagerli disclosed receiving a speaker's fee from Pfizer in the past.

LONDON – In the everyday setting, HLA-B27 positivity is the strongest predictor of an early, good response to the first use of an anti–tumor necrosis factor agent in patients with ankylosing spondylitis, according to the results of a longitudinal, observational study.

Other “real-world” and independent predictors of a good response using the ankylosing spondylitis disease activity score (ASDAS) are younger age, male sex, a higher baseline C-reactive protein (CRP) level, and a higher baseline patient global assessment score.

“TNF [tumor necrosis factor] inhibitors are effective in reducing symptoms in ankylosing spondylitis [AS], but not all patients have a response, and [they] sometimes have side effects, and the medication is expensive,” said Karen Fagerli, Ph.D., of the department of rheumatology at Diakonhjemmet Hospital in Oslo.

“So we want to identify characteristics of patients who will have a response in order to potentially utilize this knowledge when selecting patients for TNF-inhibitor therapy, and [therefore] treat patients with an optimized benefit-to-risk ratio,” Dr. Fagerli added. ASDAS was used as the main outcome measure, which may be the first time it has been used in an observational study setting.

Using data from the NOR-DMARD (Norway–Disease-Modifying Antirheumatic Drug) register, researchers identified a study population of 171 patients with AS who were starting a TNF inhibitor for the first time.

NOR-DMARD is a large, observational register that includes all patients with inflammatory arthropathies who are starting treatment with a DMARD for the first time at five rheumatology centers in Norway. Patients are routinely assessed at baseline, then after 3, 6, and 12 months, and then annually.

ASDAS major improvement was defined as a change in score of 2 or more; this was achieved by 32.7% of patients after 3 months of anti-TNF therapy.

Several parameters that had been identified as predictors of response in univariate analysis did not hold up as being statistically significant in a multivariate analysis model; these included the number of swollen joints, physician's global score, the Bath Ankylosing Spondylitis Disease Activity Index (BASDAI), and the Bath Ankylosing Spondylitis Functional Activity Index (BASFAI)

Patients who were HLA-B27 positive had a much higher chance of achieving ASDAS major improvement at 3 months than did those who were HLA-B27 negative (odds ratio, 6.72; 95% confidence interval, 1.33-33.87; P = .02).

Baseline CRP levels higher than 10 mg/L were also significantly predictive of an early treatment response (OR, 5.31; 95% CI, 2.23-12.42; P less than .001).

The next strongest predictor was male sex, with men almost three times more likely than women to show a benefit of anti-TNF treatment at 3 months (OR, 2.69; 95% CI, 1.04-7.00; P less than .04). However, the majority of the study population (73.4%) was male.

For every 1-year increase in age, the likelihood of achieving ASDAS major improvement declined, with young patients faring the best overall (OR, 0.95; 95% CI, 0.91-1.00; P less than .03). Furthermore, for every 10-mm increase in a 0- to 100-mm visual analog scale of patient global assessment, the chance of a good response improved (OR, 1.75; 95% CI, 1.40-2.19; P less than .0001).

Taken together, these data could help clinicians to identify patients who not only may respond to anti-TNF inhibitors but also should be prioritized for such treatment. However, “this is on a crude level; we don't know to what extent we can use [this information] on an individual level,” Dr. Fagerli said in an interview.

“We know for certain that there are patients who have none of these characteristics that I've talked about, who do get a response, so this is not the full truth; this is a little piece of the puzzle.”

Major Finding: The odds ratio for patients who were HLA-B27 positive and achieved ASDAS major improvement (greater than or equal to 2.0) at 3 months was 6.72, compared with those who were not (95% CI, 1.33-33.87; P = .02).

Data Source: Longitudinal, observational study of 171 patients with AS who were treated with an anti-TNF agent for the first time and were enrolled in NOR-DMARD, a register of adult patients with inflammatory arthropathies who were treated at five rheumatology centers in Norway.

Disclosures: Dr. Fagerli disclosed receiving a speaker's fee from Pfizer in the past.

LONDON – In the everyday setting, HLA-B27 positivity is the strongest predictor of an early, good response to the first use of an anti–tumor necrosis factor agent in patients with ankylosing spondylitis, according to the results of a longitudinal, observational study.

Other “real-world” and independent predictors of a good response using the ankylosing spondylitis disease activity score (ASDAS) are younger age, male sex, a higher baseline C-reactive protein (CRP) level, and a higher baseline patient global assessment score.

“TNF [tumor necrosis factor] inhibitors are effective in reducing symptoms in ankylosing spondylitis [AS], but not all patients have a response, and [they] sometimes have side effects, and the medication is expensive,” said Karen Fagerli, Ph.D., of the department of rheumatology at Diakonhjemmet Hospital in Oslo.

“So we want to identify characteristics of patients who will have a response in order to potentially utilize this knowledge when selecting patients for TNF-inhibitor therapy, and [therefore] treat patients with an optimized benefit-to-risk ratio,” Dr. Fagerli added. ASDAS was used as the main outcome measure, which may be the first time it has been used in an observational study setting.

Using data from the NOR-DMARD (Norway–Disease-Modifying Antirheumatic Drug) register, researchers identified a study population of 171 patients with AS who were starting a TNF inhibitor for the first time.

NOR-DMARD is a large, observational register that includes all patients with inflammatory arthropathies who are starting treatment with a DMARD for the first time at five rheumatology centers in Norway. Patients are routinely assessed at baseline, then after 3, 6, and 12 months, and then annually.

ASDAS major improvement was defined as a change in score of 2 or more; this was achieved by 32.7% of patients after 3 months of anti-TNF therapy.

Several parameters that had been identified as predictors of response in univariate analysis did not hold up as being statistically significant in a multivariate analysis model; these included the number of swollen joints, physician's global score, the Bath Ankylosing Spondylitis Disease Activity Index (BASDAI), and the Bath Ankylosing Spondylitis Functional Activity Index (BASFAI)

Patients who were HLA-B27 positive had a much higher chance of achieving ASDAS major improvement at 3 months than did those who were HLA-B27 negative (odds ratio, 6.72; 95% confidence interval, 1.33-33.87; P = .02).

Baseline CRP levels higher than 10 mg/L were also significantly predictive of an early treatment response (OR, 5.31; 95% CI, 2.23-12.42; P less than .001).

The next strongest predictor was male sex, with men almost three times more likely than women to show a benefit of anti-TNF treatment at 3 months (OR, 2.69; 95% CI, 1.04-7.00; P less than .04). However, the majority of the study population (73.4%) was male.

For every 1-year increase in age, the likelihood of achieving ASDAS major improvement declined, with young patients faring the best overall (OR, 0.95; 95% CI, 0.91-1.00; P less than .03). Furthermore, for every 10-mm increase in a 0- to 100-mm visual analog scale of patient global assessment, the chance of a good response improved (OR, 1.75; 95% CI, 1.40-2.19; P less than .0001).

Taken together, these data could help clinicians to identify patients who not only may respond to anti-TNF inhibitors but also should be prioritized for such treatment. However, “this is on a crude level; we don't know to what extent we can use [this information] on an individual level,” Dr. Fagerli said in an interview.

“We know for certain that there are patients who have none of these characteristics that I've talked about, who do get a response, so this is not the full truth; this is a little piece of the puzzle.”

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RA Patients Lack Care Following Heart Attack

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RA Patients Lack Care Following Heart Attack

Major Finding: Odds ratios for the prescription of aspirin, a statin, and beta-blockers 30 days after a first MI were 0.75, 0.68, and 0.76, respectively.

Data Source: Danish registry study of 66,389 patients – 875 (1.3%) with RA – who had a first MI between 2002 and 2009.

Disclosures: Dr. Lindhardsen and Dr. Schett had no conflicts of interest to declare.

LONDON – Patients with rheumatoid arthritis who have had a heart attack for the first time do not appear to be getting medications recommended to prevent a further cardiovascular event, according to the findings of a large Danish study.

Aspirin, statins, and beta-blockers – cardioprotective medications that are given as the standard of care to most patients immediately following a myocardial infarction – were all less frequently prescribed to patients with rheumatoid arthritis (RA) than to members of the general patient population.

Indeed, 1 month after an MI, the odds ratios for the prescription of these drugs were 0.75 (95% confidence interval, 0.63-0.90) for aspirin, 0.68 (95% CI, 0.57-0.82) for a statin, and 0.76 (95% CI, 0.63-0.91) for beta-blockers. These results did not change greatly at follow-ups of 3 months, 6 months, or 1 year.

The increased risk of cardiovascular disease in RA is well known and could result from a number of causes, including the presence of classical risk factors such as dyslipidemia and hypertension, possible adverse effects of RA treatment, and an accelerated atherosclerotic process driven by the high levels of inflammation characteristic of the rheumatic disease.

“What's not been considered, [however,] and perhaps the simplest explanation, is whether or not there is undertreatment of [RA] patients,” Dr. Jesper Lindhardsen, of the cardiology department at Gentofte University Hospital, Copenhagen, said at a press briefing during the congress.

To determine whether patients with RA were being given standard cardioprotective medications after a first MI, he and his colleagues analyzed data from several Danish patient registries, including those giving prescription records, details of comorbidities, and income.

The study population consisted of 66,389 patients who had had a first heart attack between 2002 and 2009. Of these, 875 (1.3%) had RA. The median age was 72.6 years for RA patients and 69.4 years for patients without RA.

At baseline, the use of cardioprotective medications by patients with and without RA were relatively similar or the same, at 27% and 25.1%, respectively, for aspirin; 19.1% and 19.1% for a statin; 23.9% and 22.5% for a beta-blocker; and 3.3% and 2.2% for clopidogrel.

Although aspirin, statin, and beta-blocker use was later found to be lower in the RA patients than in the non-RA patients throughout the early post-MI period, there was no significant difference in the prescription of clopidogrel at 1, 3, or 6 months or at 1 year.

Commenting on the findings in an interview, Dr. Lindhardsen conceded that it's not known what medications patients were taking before they had their heart attack, which could influence the findings.

Dr. Georg Schett, who is chief of rheumatology at the University of Erlangen-Nuremberg, Germany, but was not involved in the study, said the findings illustrate that the high cardiovascular risk in patients with RA is still not being taken seriously enough.

Indeed, Dr. Lindhardsen and his colleagues recently published data showing that RA is associated with the same risk of MI as diabetes (Ann. Rheum. Dis. 2011;70:929-34).

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Major Finding: Odds ratios for the prescription of aspirin, a statin, and beta-blockers 30 days after a first MI were 0.75, 0.68, and 0.76, respectively.

Data Source: Danish registry study of 66,389 patients – 875 (1.3%) with RA – who had a first MI between 2002 and 2009.

Disclosures: Dr. Lindhardsen and Dr. Schett had no conflicts of interest to declare.

LONDON – Patients with rheumatoid arthritis who have had a heart attack for the first time do not appear to be getting medications recommended to prevent a further cardiovascular event, according to the findings of a large Danish study.

Aspirin, statins, and beta-blockers – cardioprotective medications that are given as the standard of care to most patients immediately following a myocardial infarction – were all less frequently prescribed to patients with rheumatoid arthritis (RA) than to members of the general patient population.

Indeed, 1 month after an MI, the odds ratios for the prescription of these drugs were 0.75 (95% confidence interval, 0.63-0.90) for aspirin, 0.68 (95% CI, 0.57-0.82) for a statin, and 0.76 (95% CI, 0.63-0.91) for beta-blockers. These results did not change greatly at follow-ups of 3 months, 6 months, or 1 year.

The increased risk of cardiovascular disease in RA is well known and could result from a number of causes, including the presence of classical risk factors such as dyslipidemia and hypertension, possible adverse effects of RA treatment, and an accelerated atherosclerotic process driven by the high levels of inflammation characteristic of the rheumatic disease.

“What's not been considered, [however,] and perhaps the simplest explanation, is whether or not there is undertreatment of [RA] patients,” Dr. Jesper Lindhardsen, of the cardiology department at Gentofte University Hospital, Copenhagen, said at a press briefing during the congress.

To determine whether patients with RA were being given standard cardioprotective medications after a first MI, he and his colleagues analyzed data from several Danish patient registries, including those giving prescription records, details of comorbidities, and income.

The study population consisted of 66,389 patients who had had a first heart attack between 2002 and 2009. Of these, 875 (1.3%) had RA. The median age was 72.6 years for RA patients and 69.4 years for patients without RA.

At baseline, the use of cardioprotective medications by patients with and without RA were relatively similar or the same, at 27% and 25.1%, respectively, for aspirin; 19.1% and 19.1% for a statin; 23.9% and 22.5% for a beta-blocker; and 3.3% and 2.2% for clopidogrel.

Although aspirin, statin, and beta-blocker use was later found to be lower in the RA patients than in the non-RA patients throughout the early post-MI period, there was no significant difference in the prescription of clopidogrel at 1, 3, or 6 months or at 1 year.

Commenting on the findings in an interview, Dr. Lindhardsen conceded that it's not known what medications patients were taking before they had their heart attack, which could influence the findings.

Dr. Georg Schett, who is chief of rheumatology at the University of Erlangen-Nuremberg, Germany, but was not involved in the study, said the findings illustrate that the high cardiovascular risk in patients with RA is still not being taken seriously enough.

Indeed, Dr. Lindhardsen and his colleagues recently published data showing that RA is associated with the same risk of MI as diabetes (Ann. Rheum. Dis. 2011;70:929-34).

Major Finding: Odds ratios for the prescription of aspirin, a statin, and beta-blockers 30 days after a first MI were 0.75, 0.68, and 0.76, respectively.

Data Source: Danish registry study of 66,389 patients – 875 (1.3%) with RA – who had a first MI between 2002 and 2009.

Disclosures: Dr. Lindhardsen and Dr. Schett had no conflicts of interest to declare.

LONDON – Patients with rheumatoid arthritis who have had a heart attack for the first time do not appear to be getting medications recommended to prevent a further cardiovascular event, according to the findings of a large Danish study.

Aspirin, statins, and beta-blockers – cardioprotective medications that are given as the standard of care to most patients immediately following a myocardial infarction – were all less frequently prescribed to patients with rheumatoid arthritis (RA) than to members of the general patient population.

Indeed, 1 month after an MI, the odds ratios for the prescription of these drugs were 0.75 (95% confidence interval, 0.63-0.90) for aspirin, 0.68 (95% CI, 0.57-0.82) for a statin, and 0.76 (95% CI, 0.63-0.91) for beta-blockers. These results did not change greatly at follow-ups of 3 months, 6 months, or 1 year.

The increased risk of cardiovascular disease in RA is well known and could result from a number of causes, including the presence of classical risk factors such as dyslipidemia and hypertension, possible adverse effects of RA treatment, and an accelerated atherosclerotic process driven by the high levels of inflammation characteristic of the rheumatic disease.

“What's not been considered, [however,] and perhaps the simplest explanation, is whether or not there is undertreatment of [RA] patients,” Dr. Jesper Lindhardsen, of the cardiology department at Gentofte University Hospital, Copenhagen, said at a press briefing during the congress.

To determine whether patients with RA were being given standard cardioprotective medications after a first MI, he and his colleagues analyzed data from several Danish patient registries, including those giving prescription records, details of comorbidities, and income.

The study population consisted of 66,389 patients who had had a first heart attack between 2002 and 2009. Of these, 875 (1.3%) had RA. The median age was 72.6 years for RA patients and 69.4 years for patients without RA.

At baseline, the use of cardioprotective medications by patients with and without RA were relatively similar or the same, at 27% and 25.1%, respectively, for aspirin; 19.1% and 19.1% for a statin; 23.9% and 22.5% for a beta-blocker; and 3.3% and 2.2% for clopidogrel.

Although aspirin, statin, and beta-blocker use was later found to be lower in the RA patients than in the non-RA patients throughout the early post-MI period, there was no significant difference in the prescription of clopidogrel at 1, 3, or 6 months or at 1 year.

Commenting on the findings in an interview, Dr. Lindhardsen conceded that it's not known what medications patients were taking before they had their heart attack, which could influence the findings.

Dr. Georg Schett, who is chief of rheumatology at the University of Erlangen-Nuremberg, Germany, but was not involved in the study, said the findings illustrate that the high cardiovascular risk in patients with RA is still not being taken seriously enough.

Indeed, Dr. Lindhardsen and his colleagues recently published data showing that RA is associated with the same risk of MI as diabetes (Ann. Rheum. Dis. 2011;70:929-34).

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Blinatumomab Shows BiTE in Relapsed/Refractory ALL

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LONDON – The investigational agent blinatumomab could help more patients with relapsed or refractory acute lymphoblastic leukemia achieve remission, compared with conventional treatment strategies, interim findings of an exploratory phase II trial suggest.

Although a small study – just 12 patients were included in the analysis – "we saw a response rate of 75%," principal study investigator Dr. Max S. Topp said in an interview at the annual European Hematology Association congress.

"Obviously it’s a very small number of patients," Dr. Topp, a professor of medicine and consultant in hematology at the University of Wurzburg in Munich, conceded. "Nevertheless it’s basically more than double what you would expect."

The outlook for patients with relapsed or refractory B-precursor acute lymphoblastic leukemia (ALL) is often grim, Dr. Topp noted, with low response rates to intensive chemotherapy (17%-45%), and a high chance of further relapse with a median duration of 4-5 months for complete remission (CR).There is also a high rate of treatment-related mortality, with up to a quarter of patients dying during their treatment.

"Blinatumomab is a new kind of drug. It’s not actually an antibody in the classical sense, which is more passive. This is actually something that is actively looking for the tumor, as it uses the T cells to exert its action," Dr. Topp explained.

According to Micromet, the company developing the novel agent, blinatumomab is the most advanced of a new class of agents called BiTE (bispecific T-cell engager) antibodies. These agents are designed to direct cytotoxic T-cells to CD19-expressing cancer cells (Science 2008;321:974-7).

Data from a phase I study have already shown that blinatumomab is active in the treatment of relapsed or refractory B-cell non-Hodgkin’s lymphoma (American Society of Hematology annual meeting, abstract 2880). Dr. Topp and team have also demonstrated its tolerability and activity in patients with ALL who had minimal residual disease (MRD) (J. Clin. Oncol. 2011;29:2493-8).

"We then asked the question if you can actually treat full-blown relapse, and it looks like we can make a difference here," Dr. Topp observed.

The ongoing, open-label phase II study currently involves seven patients aged a median of 37 years who are being treated with blinatumomab at a dose of 15 mcg/m2 per day over three cycles and for maintenance treatment. Another five patients, with a median age of 60 years, are receiving the drug at an initial dose of 5 mcg/m2 per day, then at a dose of 15 or 30 mcg/m2 per day (cohort 2). Blinatumomab is delivered via continuous intravenous infusion for 2 weeks, with a 2-week treatment-free period.

Although the agent is in its very early days, results show that it has great promise in the treatment of relapsed or refractory ALL. The overall CR rate was 75%, and 71% in patients given the steady 15-mcg dose of blinatumomab and 80% in those whose dose was increased in subsequent cycles.

The increasing dosing regimen appears to be associated with better tolerability. "Adapting the system to have a slow start with 5 mcg and going up to 15 mcg we have had no severe adverse events ... and that is great news," Dr. Topp observed.

Some of the most common side effects seen in the trial to date include raised gamma-glutamyltransferase and C-reactive protein, peripheral edema, fatigue, pyrexia. Blood fibrinogen and fibrin d-dimer have also been increased, suggesting that thrombotic complications could be a future concern.

The bottom line, said Dr. Topp, is that "we have a non-chemotherapy, immunotherapy-based, effective treatment for patients with relapsed ALL, with very good safety profile."

Research is ongoing and a further 10 patients are likely to be included in the current trial. "We’re looking at the safety issues. We have to find the most likely regimen which we would like to use," Dr. Topp said.

The study was funded by Micromet AG. Dr. Topp is the principal investigator for the trial and disclosed acting as a consultant to the company.

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LONDON – The investigational agent blinatumomab could help more patients with relapsed or refractory acute lymphoblastic leukemia achieve remission, compared with conventional treatment strategies, interim findings of an exploratory phase II trial suggest.

Although a small study – just 12 patients were included in the analysis – "we saw a response rate of 75%," principal study investigator Dr. Max S. Topp said in an interview at the annual European Hematology Association congress.

"Obviously it’s a very small number of patients," Dr. Topp, a professor of medicine and consultant in hematology at the University of Wurzburg in Munich, conceded. "Nevertheless it’s basically more than double what you would expect."

The outlook for patients with relapsed or refractory B-precursor acute lymphoblastic leukemia (ALL) is often grim, Dr. Topp noted, with low response rates to intensive chemotherapy (17%-45%), and a high chance of further relapse with a median duration of 4-5 months for complete remission (CR).There is also a high rate of treatment-related mortality, with up to a quarter of patients dying during their treatment.

"Blinatumomab is a new kind of drug. It’s not actually an antibody in the classical sense, which is more passive. This is actually something that is actively looking for the tumor, as it uses the T cells to exert its action," Dr. Topp explained.

According to Micromet, the company developing the novel agent, blinatumomab is the most advanced of a new class of agents called BiTE (bispecific T-cell engager) antibodies. These agents are designed to direct cytotoxic T-cells to CD19-expressing cancer cells (Science 2008;321:974-7).

Data from a phase I study have already shown that blinatumomab is active in the treatment of relapsed or refractory B-cell non-Hodgkin’s lymphoma (American Society of Hematology annual meeting, abstract 2880). Dr. Topp and team have also demonstrated its tolerability and activity in patients with ALL who had minimal residual disease (MRD) (J. Clin. Oncol. 2011;29:2493-8).

"We then asked the question if you can actually treat full-blown relapse, and it looks like we can make a difference here," Dr. Topp observed.

The ongoing, open-label phase II study currently involves seven patients aged a median of 37 years who are being treated with blinatumomab at a dose of 15 mcg/m2 per day over three cycles and for maintenance treatment. Another five patients, with a median age of 60 years, are receiving the drug at an initial dose of 5 mcg/m2 per day, then at a dose of 15 or 30 mcg/m2 per day (cohort 2). Blinatumomab is delivered via continuous intravenous infusion for 2 weeks, with a 2-week treatment-free period.

Although the agent is in its very early days, results show that it has great promise in the treatment of relapsed or refractory ALL. The overall CR rate was 75%, and 71% in patients given the steady 15-mcg dose of blinatumomab and 80% in those whose dose was increased in subsequent cycles.

The increasing dosing regimen appears to be associated with better tolerability. "Adapting the system to have a slow start with 5 mcg and going up to 15 mcg we have had no severe adverse events ... and that is great news," Dr. Topp observed.

Some of the most common side effects seen in the trial to date include raised gamma-glutamyltransferase and C-reactive protein, peripheral edema, fatigue, pyrexia. Blood fibrinogen and fibrin d-dimer have also been increased, suggesting that thrombotic complications could be a future concern.

The bottom line, said Dr. Topp, is that "we have a non-chemotherapy, immunotherapy-based, effective treatment for patients with relapsed ALL, with very good safety profile."

Research is ongoing and a further 10 patients are likely to be included in the current trial. "We’re looking at the safety issues. We have to find the most likely regimen which we would like to use," Dr. Topp said.

The study was funded by Micromet AG. Dr. Topp is the principal investigator for the trial and disclosed acting as a consultant to the company.

LONDON – The investigational agent blinatumomab could help more patients with relapsed or refractory acute lymphoblastic leukemia achieve remission, compared with conventional treatment strategies, interim findings of an exploratory phase II trial suggest.

Although a small study – just 12 patients were included in the analysis – "we saw a response rate of 75%," principal study investigator Dr. Max S. Topp said in an interview at the annual European Hematology Association congress.

"Obviously it’s a very small number of patients," Dr. Topp, a professor of medicine and consultant in hematology at the University of Wurzburg in Munich, conceded. "Nevertheless it’s basically more than double what you would expect."

The outlook for patients with relapsed or refractory B-precursor acute lymphoblastic leukemia (ALL) is often grim, Dr. Topp noted, with low response rates to intensive chemotherapy (17%-45%), and a high chance of further relapse with a median duration of 4-5 months for complete remission (CR).There is also a high rate of treatment-related mortality, with up to a quarter of patients dying during their treatment.

"Blinatumomab is a new kind of drug. It’s not actually an antibody in the classical sense, which is more passive. This is actually something that is actively looking for the tumor, as it uses the T cells to exert its action," Dr. Topp explained.

According to Micromet, the company developing the novel agent, blinatumomab is the most advanced of a new class of agents called BiTE (bispecific T-cell engager) antibodies. These agents are designed to direct cytotoxic T-cells to CD19-expressing cancer cells (Science 2008;321:974-7).

Data from a phase I study have already shown that blinatumomab is active in the treatment of relapsed or refractory B-cell non-Hodgkin’s lymphoma (American Society of Hematology annual meeting, abstract 2880). Dr. Topp and team have also demonstrated its tolerability and activity in patients with ALL who had minimal residual disease (MRD) (J. Clin. Oncol. 2011;29:2493-8).

"We then asked the question if you can actually treat full-blown relapse, and it looks like we can make a difference here," Dr. Topp observed.

The ongoing, open-label phase II study currently involves seven patients aged a median of 37 years who are being treated with blinatumomab at a dose of 15 mcg/m2 per day over three cycles and for maintenance treatment. Another five patients, with a median age of 60 years, are receiving the drug at an initial dose of 5 mcg/m2 per day, then at a dose of 15 or 30 mcg/m2 per day (cohort 2). Blinatumomab is delivered via continuous intravenous infusion for 2 weeks, with a 2-week treatment-free period.

Although the agent is in its very early days, results show that it has great promise in the treatment of relapsed or refractory ALL. The overall CR rate was 75%, and 71% in patients given the steady 15-mcg dose of blinatumomab and 80% in those whose dose was increased in subsequent cycles.

The increasing dosing regimen appears to be associated with better tolerability. "Adapting the system to have a slow start with 5 mcg and going up to 15 mcg we have had no severe adverse events ... and that is great news," Dr. Topp observed.

Some of the most common side effects seen in the trial to date include raised gamma-glutamyltransferase and C-reactive protein, peripheral edema, fatigue, pyrexia. Blood fibrinogen and fibrin d-dimer have also been increased, suggesting that thrombotic complications could be a future concern.

The bottom line, said Dr. Topp, is that "we have a non-chemotherapy, immunotherapy-based, effective treatment for patients with relapsed ALL, with very good safety profile."

Research is ongoing and a further 10 patients are likely to be included in the current trial. "We’re looking at the safety issues. We have to find the most likely regimen which we would like to use," Dr. Topp said.

The study was funded by Micromet AG. Dr. Topp is the principal investigator for the trial and disclosed acting as a consultant to the company.

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Major Finding: The overall complete response rate was 75%, and 71% in patients given a steady 15 mcg/m2 dose of blinatumomab and 80% in those whose dose was increased in subsequent cycles.

Data Source: An open-label, multicenter, exploratory phase II study in adult patients with relapsed/refractory B-precursor acute lymphoblastic leukemia (ALL).

Disclosures: The study was funded by Micromet AG. Dr. Topp disclosed acting as a consultant to the company and is the principal investigator for the trial.

HLA-B27 Positivity Strongest Predictor of TNF-Inhibitor Response in Ankylosing Spondylitis

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LONDON – In an everyday setting, HLA-B27 positivity is the strongest predictor of an early, good response to the first use of an anti-tumor necrosis factor agent in patients with ankylosing spondylitis, according to the results of a longitudinal, observational study.

Other "real-world" and independent predictors of a good response using the ankylosing spondylitis disease activity score (ASDAS) are younger age, male sex, a higher baseline C-reactive protein (CRP) level, and a higher baseline patient global assessment score.

"TNF [tumor necrosis factor] inhibitors are effective in reducing symptoms in ankylosing spondylitis [AS], but not all patients have a response, [they] sometimes have side effects, and the medication is expensive," said Karen Fagerli, Ph.D., of the department of rheumatology at Diakonhjemmet Hospital in Oslo.

    Karen M. Fagerli

"So we want to identify characteristics of patients who will have a response in order to potentially utilize this knowledge when selecting patients for TNF-inhibitor therapy, and [therefore] treat patients with an optimized benefit-to-risk ratio," Dr. Fagerli added. ASDAS was used as the main outcome measure, which may be the first time it has been used in an observational study setting.

Using data from the NOR-DMARD (Norway-Disease-Modifying Antirheumatic Drug) register, researchers identified a study population of 171 patients with AS who were starting a TNF-inhibitor for the first time. The aim was to identify predictors of response to this treatment using the recently developed ASDAS outcome measure.

NOR-DMARD is a large, observational register that includes all patients with inflammatory arthropathies who are starting treatment with a DMARD for the first time at five rheumatology centers in Norway. Patients are routinely assessed at baseline, then after 3, 6, and 12 months, and then annually.

ASDAS major improvement was defined as a change in score of 2 or more; this was achieved by 32.7% of patients after 3 months of anti-TNF therapy.

Several parameters that had been identified as predictors of response in univariate analysis did not hold up as being statistically significant in a multivariate analysis model; these included the number of swollen joints, physician’s global score, the Bath Ankylosing Spondylitis Disease Activity Index (BASDAI), and the Bath Ankylosing Spondylitis Functional Activity Index (BASFAI).

Patients who were HLA-B27 positive had a much higher chance of achieving ASDAS major improvement at 3 months than did those who were HLA-B27 negative (odds ratio, 6.72; 95% confidence interval, 1.33-33.87; P = .02).

Baseline CRP levels higher than 10 mg/L were also significantly predictive of an early treatment response (OR, 5.31; 95% CI, 2.23-12.42; P less than .001).

The next strongest predictor was male sex, with men almost three times more likely than women to show a benefit of anti-TNF treatment at 3 months (OR, 2.69; 95% CI, 1.04-7.00; P less than .04). However, the majority of the study population (73.4%) was male.

For every 1-year increase in age, the likelihood of achieving ASDAS major improvement declined, with young patients faring the best overall (OR, 0.95; 95% CI, 0.91-1.00; P less than .03).

Furthermore, for every 10-mm increase in a 0- to 100-mm visual analog scale of patient global assessment, the chance of a good response improved (OR, 1.75; 95% CI, 1.40-2.19; P less than .0001).

Taken together, these data could help clinicians to identify patients who not only may respond to anti-TNF inhibitors but also should be prioritized for such treatment.

However, "this is on a crude level; we don’t know to what extent we can use [this information] on an individual level," Dr. Fagerli said in an interview. "We know for certain that there are patients who have none of these characteristics that I’ve talked about, who do get a response, so this is not the full truth; this is a little piece of the puzzle."

Dr. Fagerli disclosed receiving a speaker’s fee from Pfizer in the past.

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LONDON – In an everyday setting, HLA-B27 positivity is the strongest predictor of an early, good response to the first use of an anti-tumor necrosis factor agent in patients with ankylosing spondylitis, according to the results of a longitudinal, observational study.

Other "real-world" and independent predictors of a good response using the ankylosing spondylitis disease activity score (ASDAS) are younger age, male sex, a higher baseline C-reactive protein (CRP) level, and a higher baseline patient global assessment score.

"TNF [tumor necrosis factor] inhibitors are effective in reducing symptoms in ankylosing spondylitis [AS], but not all patients have a response, [they] sometimes have side effects, and the medication is expensive," said Karen Fagerli, Ph.D., of the department of rheumatology at Diakonhjemmet Hospital in Oslo.

    Karen M. Fagerli

"So we want to identify characteristics of patients who will have a response in order to potentially utilize this knowledge when selecting patients for TNF-inhibitor therapy, and [therefore] treat patients with an optimized benefit-to-risk ratio," Dr. Fagerli added. ASDAS was used as the main outcome measure, which may be the first time it has been used in an observational study setting.

Using data from the NOR-DMARD (Norway-Disease-Modifying Antirheumatic Drug) register, researchers identified a study population of 171 patients with AS who were starting a TNF-inhibitor for the first time. The aim was to identify predictors of response to this treatment using the recently developed ASDAS outcome measure.

NOR-DMARD is a large, observational register that includes all patients with inflammatory arthropathies who are starting treatment with a DMARD for the first time at five rheumatology centers in Norway. Patients are routinely assessed at baseline, then after 3, 6, and 12 months, and then annually.

ASDAS major improvement was defined as a change in score of 2 or more; this was achieved by 32.7% of patients after 3 months of anti-TNF therapy.

Several parameters that had been identified as predictors of response in univariate analysis did not hold up as being statistically significant in a multivariate analysis model; these included the number of swollen joints, physician’s global score, the Bath Ankylosing Spondylitis Disease Activity Index (BASDAI), and the Bath Ankylosing Spondylitis Functional Activity Index (BASFAI).

Patients who were HLA-B27 positive had a much higher chance of achieving ASDAS major improvement at 3 months than did those who were HLA-B27 negative (odds ratio, 6.72; 95% confidence interval, 1.33-33.87; P = .02).

Baseline CRP levels higher than 10 mg/L were also significantly predictive of an early treatment response (OR, 5.31; 95% CI, 2.23-12.42; P less than .001).

The next strongest predictor was male sex, with men almost three times more likely than women to show a benefit of anti-TNF treatment at 3 months (OR, 2.69; 95% CI, 1.04-7.00; P less than .04). However, the majority of the study population (73.4%) was male.

For every 1-year increase in age, the likelihood of achieving ASDAS major improvement declined, with young patients faring the best overall (OR, 0.95; 95% CI, 0.91-1.00; P less than .03).

Furthermore, for every 10-mm increase in a 0- to 100-mm visual analog scale of patient global assessment, the chance of a good response improved (OR, 1.75; 95% CI, 1.40-2.19; P less than .0001).

Taken together, these data could help clinicians to identify patients who not only may respond to anti-TNF inhibitors but also should be prioritized for such treatment.

However, "this is on a crude level; we don’t know to what extent we can use [this information] on an individual level," Dr. Fagerli said in an interview. "We know for certain that there are patients who have none of these characteristics that I’ve talked about, who do get a response, so this is not the full truth; this is a little piece of the puzzle."

Dr. Fagerli disclosed receiving a speaker’s fee from Pfizer in the past.

LONDON – In an everyday setting, HLA-B27 positivity is the strongest predictor of an early, good response to the first use of an anti-tumor necrosis factor agent in patients with ankylosing spondylitis, according to the results of a longitudinal, observational study.

Other "real-world" and independent predictors of a good response using the ankylosing spondylitis disease activity score (ASDAS) are younger age, male sex, a higher baseline C-reactive protein (CRP) level, and a higher baseline patient global assessment score.

"TNF [tumor necrosis factor] inhibitors are effective in reducing symptoms in ankylosing spondylitis [AS], but not all patients have a response, [they] sometimes have side effects, and the medication is expensive," said Karen Fagerli, Ph.D., of the department of rheumatology at Diakonhjemmet Hospital in Oslo.

    Karen M. Fagerli

"So we want to identify characteristics of patients who will have a response in order to potentially utilize this knowledge when selecting patients for TNF-inhibitor therapy, and [therefore] treat patients with an optimized benefit-to-risk ratio," Dr. Fagerli added. ASDAS was used as the main outcome measure, which may be the first time it has been used in an observational study setting.

Using data from the NOR-DMARD (Norway-Disease-Modifying Antirheumatic Drug) register, researchers identified a study population of 171 patients with AS who were starting a TNF-inhibitor for the first time. The aim was to identify predictors of response to this treatment using the recently developed ASDAS outcome measure.

NOR-DMARD is a large, observational register that includes all patients with inflammatory arthropathies who are starting treatment with a DMARD for the first time at five rheumatology centers in Norway. Patients are routinely assessed at baseline, then after 3, 6, and 12 months, and then annually.

ASDAS major improvement was defined as a change in score of 2 or more; this was achieved by 32.7% of patients after 3 months of anti-TNF therapy.

Several parameters that had been identified as predictors of response in univariate analysis did not hold up as being statistically significant in a multivariate analysis model; these included the number of swollen joints, physician’s global score, the Bath Ankylosing Spondylitis Disease Activity Index (BASDAI), and the Bath Ankylosing Spondylitis Functional Activity Index (BASFAI).

Patients who were HLA-B27 positive had a much higher chance of achieving ASDAS major improvement at 3 months than did those who were HLA-B27 negative (odds ratio, 6.72; 95% confidence interval, 1.33-33.87; P = .02).

Baseline CRP levels higher than 10 mg/L were also significantly predictive of an early treatment response (OR, 5.31; 95% CI, 2.23-12.42; P less than .001).

The next strongest predictor was male sex, with men almost three times more likely than women to show a benefit of anti-TNF treatment at 3 months (OR, 2.69; 95% CI, 1.04-7.00; P less than .04). However, the majority of the study population (73.4%) was male.

For every 1-year increase in age, the likelihood of achieving ASDAS major improvement declined, with young patients faring the best overall (OR, 0.95; 95% CI, 0.91-1.00; P less than .03).

Furthermore, for every 10-mm increase in a 0- to 100-mm visual analog scale of patient global assessment, the chance of a good response improved (OR, 1.75; 95% CI, 1.40-2.19; P less than .0001).

Taken together, these data could help clinicians to identify patients who not only may respond to anti-TNF inhibitors but also should be prioritized for such treatment.

However, "this is on a crude level; we don’t know to what extent we can use [this information] on an individual level," Dr. Fagerli said in an interview. "We know for certain that there are patients who have none of these characteristics that I’ve talked about, who do get a response, so this is not the full truth; this is a little piece of the puzzle."

Dr. Fagerli disclosed receiving a speaker’s fee from Pfizer in the past.

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Major Finding: The odds ratio for patients who were HLA-B27 positive and achieved ASDAS major improvement (greater than or equal to 2.0) at 3 months was 6.72, compared with those who were not (95% CI, 1.33-33.87; P = .02).

Data Source: Longitudinal, observational study of 171 patients with AS who were treated with an anti-TNF agent for the first time and were enrolled in NOR-DMARD, a register of adult patients with inflammatory arthropathies who were treated at five rheumatology centers in Norway.

Disclosures: Dr. Fagerli disclosed receiving a speaker’s fee from Pfizer in the past.

COPD Prevalence Doubled in Rheumatoid Arthritis

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LONDON – Patients with rheumatoid arthritis have a high risk of concomitant chronic obstructive pulmonary disease, according to data from two studies.

In one of the studies – which involved more than 15,000 patients with rheumatoid arthritis (RA) and 15,000 healthy individuals as case-matched controls – the risk of the long-term lung condition was 8.9% vs. 4.4%, respectively (P less than .001).

    Dr. Suzanne Verstappen

Other data, from the Norfolk Arthritis Register (NOAR) showed that the prevalence of chronic obstructive pulmonary disease (COPD) in patients with inflammatory polyarthritis (IP) or RA was 7.3% (n = 425) at 15 years’ follow-up. Prevalence of the respiratory disease was again doubled when compared to the general population.

"Lung involvement is a common extra-articular manifestation in rheumatoid arthritis," said Dr. Suzanne Verstappen, who presented the findings from the NOAR at the annual European Congress of Rheumatology.

"As could be expected, age and gender were associated with obstructive and restrictive lung disease," said Dr. Verstappen, a research fellow at the Arthritis Research UK Epidemiology Unit at the University of Manchester, England, where the NOAR is coordinated.

Validated spirometry parameters and the Medical Research Council respiratory symptoms questionnaire were used to identify patients with IP or RA who also had COPD. The latter was distinguished from restrictive lung disease whereby the lungs are restricted by the extent that they can inflate. The prevalence of restrictive lung disease was 9.7%.

COPD was observed in 7.3% of the population at 15 years, with higher prevalence rates found in men versus women over the age of 45 years (12.7% vs. 6%, respectively) in a crude comparison. Published rates for the U.K. general population without IP or RA are 6.8% and 3.9% (Popul. Health Metr. 2007;5:8).

Like RA, COPD is a chronic and often debilitating disease. The disease manifests later in life and treatment is symptomatic rather than curative, as the obstruction in the airways is permanent and not usually reversible with bronchodilator therapy. Unlike RA, however, which has multiple etiologic factors and autoimmunity at its root, COPD is almost always caused by smoking. In the NOAR analysis, 53% of the 425 patients were ex-smokers and 13% were current smokers; 34% had never smoked.

Data from the first study, presented during a poster session by Dr. Howard Amital of Sheba Medical Centre in Tel Hashomer, Israel, showed, however, that even with smoking out of the equation, the risk of COPD in patients with RA was higher than in the general population.

Indeed, multivariate analysis showed that RA was associated with COPD after the researchers controlled for confounding factors such as age, gender, smoking, obesity and socioeconomic status.

"The strength of the association increased," Dr. Amital and colleagues reported, with an adjusted odds ratio (OR) of 2.015 (95% confidence interval 1.83-2.22; P less than .001) and an unadjusted OR of 1.89 (95% CI 1.74-2.05, P less than .0001).

The case-control study involved 15,766 patients with RA and 15,240 age- and sex-matched healthy individuals without RA. The study also found higher rates of other chronic disease in patients versus controls, including diabetes (23.9% vs. 19.8%, P less than .0001), ischemic heart disease (19.5% vs. 15.4%, P less than .0001), and heart failure (6.3% vs. 4.3%, P less than .0001).

"This study corroborates the hypothesis that COPD and RA are closely interrelated," Dr. Amital and his team concluded.

NOAR is funded by Arthritis Research UK. Dr. Verstappen and Dr. Amital and colleagues had no conflicts of interest to declare.

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LONDON – Patients with rheumatoid arthritis have a high risk of concomitant chronic obstructive pulmonary disease, according to data from two studies.

In one of the studies – which involved more than 15,000 patients with rheumatoid arthritis (RA) and 15,000 healthy individuals as case-matched controls – the risk of the long-term lung condition was 8.9% vs. 4.4%, respectively (P less than .001).

    Dr. Suzanne Verstappen

Other data, from the Norfolk Arthritis Register (NOAR) showed that the prevalence of chronic obstructive pulmonary disease (COPD) in patients with inflammatory polyarthritis (IP) or RA was 7.3% (n = 425) at 15 years’ follow-up. Prevalence of the respiratory disease was again doubled when compared to the general population.

"Lung involvement is a common extra-articular manifestation in rheumatoid arthritis," said Dr. Suzanne Verstappen, who presented the findings from the NOAR at the annual European Congress of Rheumatology.

"As could be expected, age and gender were associated with obstructive and restrictive lung disease," said Dr. Verstappen, a research fellow at the Arthritis Research UK Epidemiology Unit at the University of Manchester, England, where the NOAR is coordinated.

Validated spirometry parameters and the Medical Research Council respiratory symptoms questionnaire were used to identify patients with IP or RA who also had COPD. The latter was distinguished from restrictive lung disease whereby the lungs are restricted by the extent that they can inflate. The prevalence of restrictive lung disease was 9.7%.

COPD was observed in 7.3% of the population at 15 years, with higher prevalence rates found in men versus women over the age of 45 years (12.7% vs. 6%, respectively) in a crude comparison. Published rates for the U.K. general population without IP or RA are 6.8% and 3.9% (Popul. Health Metr. 2007;5:8).

Like RA, COPD is a chronic and often debilitating disease. The disease manifests later in life and treatment is symptomatic rather than curative, as the obstruction in the airways is permanent and not usually reversible with bronchodilator therapy. Unlike RA, however, which has multiple etiologic factors and autoimmunity at its root, COPD is almost always caused by smoking. In the NOAR analysis, 53% of the 425 patients were ex-smokers and 13% were current smokers; 34% had never smoked.

Data from the first study, presented during a poster session by Dr. Howard Amital of Sheba Medical Centre in Tel Hashomer, Israel, showed, however, that even with smoking out of the equation, the risk of COPD in patients with RA was higher than in the general population.

Indeed, multivariate analysis showed that RA was associated with COPD after the researchers controlled for confounding factors such as age, gender, smoking, obesity and socioeconomic status.

"The strength of the association increased," Dr. Amital and colleagues reported, with an adjusted odds ratio (OR) of 2.015 (95% confidence interval 1.83-2.22; P less than .001) and an unadjusted OR of 1.89 (95% CI 1.74-2.05, P less than .0001).

The case-control study involved 15,766 patients with RA and 15,240 age- and sex-matched healthy individuals without RA. The study also found higher rates of other chronic disease in patients versus controls, including diabetes (23.9% vs. 19.8%, P less than .0001), ischemic heart disease (19.5% vs. 15.4%, P less than .0001), and heart failure (6.3% vs. 4.3%, P less than .0001).

"This study corroborates the hypothesis that COPD and RA are closely interrelated," Dr. Amital and his team concluded.

NOAR is funded by Arthritis Research UK. Dr. Verstappen and Dr. Amital and colleagues had no conflicts of interest to declare.

LONDON – Patients with rheumatoid arthritis have a high risk of concomitant chronic obstructive pulmonary disease, according to data from two studies.

In one of the studies – which involved more than 15,000 patients with rheumatoid arthritis (RA) and 15,000 healthy individuals as case-matched controls – the risk of the long-term lung condition was 8.9% vs. 4.4%, respectively (P less than .001).

    Dr. Suzanne Verstappen

Other data, from the Norfolk Arthritis Register (NOAR) showed that the prevalence of chronic obstructive pulmonary disease (COPD) in patients with inflammatory polyarthritis (IP) or RA was 7.3% (n = 425) at 15 years’ follow-up. Prevalence of the respiratory disease was again doubled when compared to the general population.

"Lung involvement is a common extra-articular manifestation in rheumatoid arthritis," said Dr. Suzanne Verstappen, who presented the findings from the NOAR at the annual European Congress of Rheumatology.

"As could be expected, age and gender were associated with obstructive and restrictive lung disease," said Dr. Verstappen, a research fellow at the Arthritis Research UK Epidemiology Unit at the University of Manchester, England, where the NOAR is coordinated.

Validated spirometry parameters and the Medical Research Council respiratory symptoms questionnaire were used to identify patients with IP or RA who also had COPD. The latter was distinguished from restrictive lung disease whereby the lungs are restricted by the extent that they can inflate. The prevalence of restrictive lung disease was 9.7%.

COPD was observed in 7.3% of the population at 15 years, with higher prevalence rates found in men versus women over the age of 45 years (12.7% vs. 6%, respectively) in a crude comparison. Published rates for the U.K. general population without IP or RA are 6.8% and 3.9% (Popul. Health Metr. 2007;5:8).

Like RA, COPD is a chronic and often debilitating disease. The disease manifests later in life and treatment is symptomatic rather than curative, as the obstruction in the airways is permanent and not usually reversible with bronchodilator therapy. Unlike RA, however, which has multiple etiologic factors and autoimmunity at its root, COPD is almost always caused by smoking. In the NOAR analysis, 53% of the 425 patients were ex-smokers and 13% were current smokers; 34% had never smoked.

Data from the first study, presented during a poster session by Dr. Howard Amital of Sheba Medical Centre in Tel Hashomer, Israel, showed, however, that even with smoking out of the equation, the risk of COPD in patients with RA was higher than in the general population.

Indeed, multivariate analysis showed that RA was associated with COPD after the researchers controlled for confounding factors such as age, gender, smoking, obesity and socioeconomic status.

"The strength of the association increased," Dr. Amital and colleagues reported, with an adjusted odds ratio (OR) of 2.015 (95% confidence interval 1.83-2.22; P less than .001) and an unadjusted OR of 1.89 (95% CI 1.74-2.05, P less than .0001).

The case-control study involved 15,766 patients with RA and 15,240 age- and sex-matched healthy individuals without RA. The study also found higher rates of other chronic disease in patients versus controls, including diabetes (23.9% vs. 19.8%, P less than .0001), ischemic heart disease (19.5% vs. 15.4%, P less than .0001), and heart failure (6.3% vs. 4.3%, P less than .0001).

"This study corroborates the hypothesis that COPD and RA are closely interrelated," Dr. Amital and his team concluded.

NOAR is funded by Arthritis Research UK. Dr. Verstappen and Dr. Amital and colleagues had no conflicts of interest to declare.

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FROM THE ANNUAL EUROPEAN CONGRESS OF RHEUMATOLOGY

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Major Finding: COPD was a comorbid condition in 8.9% of patients with RA compared with 4.4% of controls from the general population in one study (P less than .001), with 7.3% of the Norfolk Arthritis Register study population also found to have the respiratory disease.

Data Source: A case-control study of more than 30,000 individuals with or without rheumatoid arthritis and data from a 15-year follow up of 435 patients with inflammatory polyarthritis or RA in the Norfolk Arthritis Register.

Disclosures: NOAR is funded by Arthritis Research UK. Dr. Verstappen and Dr. Amital and colleagues had no conflicts of interest to declare.