Heidi Splete

ORLANDO – Ten-year overall survival and event-free survival were significantly higher in adolescents and young adults with acute myeloid leukemia who were treated with a pediatric regimen vs. an adult regimen, based on data from 517 patients aged 16-21 years.

Previous studies have shown improved survival in young adults with acute lymphoblastic leukemia who were treated with a pediatric regimen, said Dr. Anna R.K. Franklin of the University of Texas M.D. Anderson Cancer Center in Houston at the annual meeting of the American Society of Hematology. Dr. Franklin and her coauthors hypothesized that survival trends might be similar in acute myeloid leukemia patients.

The researchers compared 281 young adult patients with AML in Children’s Oncology Group (COG) trials, all of whom received a pediatric regimen, vs. 149 young adults in Cancer and Leukemia Group B (CALGB) trials and 87 young adults in Southwest Oncology Group (SWOG) trials, all of whom received an adult regimen. The patients were treated in 1986-2008.

Overall survival 10 years after study entry was 45% in the COG patients vs. 34% in the CALGB/SWOG patients (P less than .05). A subgroup analysis breaking down the combined population by age showed that overall survival after 10 years was 43% in younger patients (aged 16-18 years) vs. 32% in older patients (aged 19-21 years).

The median age was 18 years overall, but the median age in the COG patients was significantly younger than the median age in the CALGB/SWOG patients (17 years vs. 20 years).

The 10-year overall survival rates by age and group were 45% for younger COG patients, 44% for older COG patients, 40% for younger CALGB/SWOG patients, and 31% for older CALGB/SWOG patients.

Overall, the 10-year event-free survival rates were 39% for younger COG patients and 17% for older COG patients vs. 23%, and 22% for younger and older CALGB/SWOG patients, respectively.

In contrast, 10-year treatment-related mortality rates were significantly higher in COG patients than CALGB/SWOG patients. The rates were 26% for younger COG patients and 30% for older COG patients vs. a constant 12% for younger and older CALGB/SWOG patients.

In this study, age was a confounding variable that made comparison of patients on adult vs. child regimens difficult, because 94% of the COG patients were younger than 19 years, Dr. Franklin noted. However, "COG studies have significantly more [treatment-related mortality] and significantly less risk of relapse than the adult trials," she said.

Significant improvements occurred in 10-year overall survival, event-free survival, and relapse risk in more recent studies compared with earlier studies, but treatment-related mortality also increased, said Dr. Franklin. Multivariate analysis of the data is ongoing to determine which specific factors impact patient outcomes in adult vs. pediatric protocols, she said.

Dr. Franklin had no financial conflicts to disclose.

ORLANDO – Ten-year overall survival and event-free survival were significantly higher in adolescents and young adults with acute myeloid leukemia who were treated with a pediatric regimen vs. an adult regimen, based on data from 517 patients aged 16-21 years.

Previous studies have shown improved survival in young adults with acute lymphoblastic leukemia who were treated with a pediatric regimen, said Dr. Anna R.K. Franklin of the University of Texas M.D. Anderson Cancer Center in Houston at the annual meeting of the American Society of Hematology. Dr. Franklin and her coauthors hypothesized that survival trends might be similar in acute myeloid leukemia patients.

The researchers compared 281 young adult patients with AML in Children’s Oncology Group (COG) trials, all of whom received a pediatric regimen, vs. 149 young adults in Cancer and Leukemia Group B (CALGB) trials and 87 young adults in Southwest Oncology Group (SWOG) trials, all of whom received an adult regimen. The patients were treated in 1986-2008.

Overall survival 10 years after study entry was 45% in the COG patients vs. 34% in the CALGB/SWOG patients (P less than .05). A subgroup analysis breaking down the combined population by age showed that overall survival after 10 years was 43% in younger patients (aged 16-18 years) vs. 32% in older patients (aged 19-21 years).

The median age was 18 years overall, but the median age in the COG patients was significantly younger than the median age in the CALGB/SWOG patients (17 years vs. 20 years).

The 10-year overall survival rates by age and group were 45% for younger COG patients, 44% for older COG patients, 40% for younger CALGB/SWOG patients, and 31% for older CALGB/SWOG patients.

Overall, the 10-year event-free survival rates were 39% for younger COG patients and 17% for older COG patients vs. 23%, and 22% for younger and older CALGB/SWOG patients, respectively.

In contrast, 10-year treatment-related mortality rates were significantly higher in COG patients than CALGB/SWOG patients. The rates were 26% for younger COG patients and 30% for older COG patients vs. a constant 12% for younger and older CALGB/SWOG patients.

In this study, age was a confounding variable that made comparison of patients on adult vs. child regimens difficult, because 94% of the COG patients were younger than 19 years, Dr. Franklin noted. However, "COG studies have significantly more [treatment-related mortality] and significantly less risk of relapse than the adult trials," she said.

Significant improvements occurred in 10-year overall survival, event-free survival, and relapse risk in more recent studies compared with earlier studies, but treatment-related mortality also increased, said Dr. Franklin. Multivariate analysis of the data is ongoing to determine which specific factors impact patient outcomes in adult vs. pediatric protocols, she said.

Dr. Franklin had no financial conflicts to disclose.

ORLANDO – Ten-year overall survival and event-free survival were significantly higher in adolescents and young adults with acute myeloid leukemia who were treated with a pediatric regimen vs. an adult regimen, based on data from 517 patients aged 16-21 years.

Previous studies have shown improved survival in young adults with acute lymphoblastic leukemia who were treated with a pediatric regimen, said Dr. Anna R.K. Franklin of the University of Texas M.D. Anderson Cancer Center in Houston at the annual meeting of the American Society of Hematology. Dr. Franklin and her coauthors hypothesized that survival trends might be similar in acute myeloid leukemia patients.

The researchers compared 281 young adult patients with AML in Children’s Oncology Group (COG) trials, all of whom received a pediatric regimen, vs. 149 young adults in Cancer and Leukemia Group B (CALGB) trials and 87 young adults in Southwest Oncology Group (SWOG) trials, all of whom received an adult regimen. The patients were treated in 1986-2008.

Overall survival 10 years after study entry was 45% in the COG patients vs. 34% in the CALGB/SWOG patients (P less than .05). A subgroup analysis breaking down the combined population by age showed that overall survival after 10 years was 43% in younger patients (aged 16-18 years) vs. 32% in older patients (aged 19-21 years).

The median age was 18 years overall, but the median age in the COG patients was significantly younger than the median age in the CALGB/SWOG patients (17 years vs. 20 years).

The 10-year overall survival rates by age and group were 45% for younger COG patients, 44% for older COG patients, 40% for younger CALGB/SWOG patients, and 31% for older CALGB/SWOG patients.

Overall, the 10-year event-free survival rates were 39% for younger COG patients and 17% for older COG patients vs. 23%, and 22% for younger and older CALGB/SWOG patients, respectively.

In contrast, 10-year treatment-related mortality rates were significantly higher in COG patients than CALGB/SWOG patients. The rates were 26% for younger COG patients and 30% for older COG patients vs. a constant 12% for younger and older CALGB/SWOG patients.

In this study, age was a confounding variable that made comparison of patients on adult vs. child regimens difficult, because 94% of the COG patients were younger than 19 years, Dr. Franklin noted. However, "COG studies have significantly more [treatment-related mortality] and significantly less risk of relapse than the adult trials," she said.

Significant improvements occurred in 10-year overall survival, event-free survival, and relapse risk in more recent studies compared with earlier studies, but treatment-related mortality also increased, said Dr. Franklin. Multivariate analysis of the data is ongoing to determine which specific factors impact patient outcomes in adult vs. pediatric protocols, she said.

Dr. Franklin had no financial conflicts to disclose.

ORLANDO – Ten-year overall survival and event-free survival were significantly higher in adolescents and young adults with acute myeloid leukemia who were treated with a pediatric regimen vs. an adult regimen, based on data from 517 patients aged 16-21 years.

Previous studies have shown improved survival in young adults with acute lymphoblastic leukemia who were treated with a pediatric regimen, said Dr. Anna R.K. Franklin of the University of Texas M.D. Anderson Cancer Center in Houston at the annual meeting of the American Society of Hematology. Dr. Franklin and her coauthors hypothesized that survival trends might be similar in acute myeloid leukemia patients.

The researchers compared 281 young adult patients with AML in Children’s Oncology Group (COG) trials, all of whom received a pediatric regimen, vs. 149 young adults in Cancer and Leukemia Group B (CALGB) trials and 87 young adults in Southwest Oncology Group (SWOG) trials, all of whom received an adult regimen. The patients were treated in 1986-2008.

Overall survival 10 years after study entry was 45% in the COG patients vs. 34% in the CALGB/SWOG patients (P less than .05). A subgroup analysis breaking down the combined population by age showed that overall survival after 10 years was 43% in younger patients (aged 16-18 years) vs. 32% in older patients (aged 19-21 years).

The median age was 18 years overall, but the median age in the COG patients was significantly younger than the median age in the CALGB/SWOG patients (17 years vs. 20 years).

The 10-year overall survival rates by age and group were 45% for younger COG patients, 44% for older COG patients, 40% for younger CALGB/SWOG patients, and 31% for older CALGB/SWOG patients.

Overall, the 10-year event-free survival rates were 39% for younger COG patients and 17% for older COG patients vs. 23%, and 22% for younger and older CALGB/SWOG patients, respectively.

In contrast, 10-year treatment-related mortality rates were significantly higher in COG patients than CALGB/SWOG patients. The rates were 26% for younger COG patients and 30% for older COG patients vs. a constant 12% for younger and older CALGB/SWOG patients.

In this study, age was a confounding variable that made comparison of patients on adult vs. child regimens difficult, because 94% of the COG patients were younger than 19 years, Dr. Franklin noted. However, "COG studies have significantly more [treatment-related mortality] and significantly less risk of relapse than the adult trials," she said.

Significant improvements occurred in 10-year overall survival, event-free survival, and relapse risk in more recent studies compared with earlier studies, but treatment-related mortality also increased, said Dr. Franklin. Multivariate analysis of the data is ongoing to determine which specific factors impact patient outcomes in adult vs. pediatric protocols, she said.

Dr. Franklin had no financial conflicts to disclose.

ORLANDO – Ten-year overall survival and event-free survival were significantly higher in adolescents and young adults with acute myeloid leukemia who were treated with a pediatric regimen vs. an adult regimen, based on data from 517 patients aged 16-21 years.

Previous studies have shown improved survival in young adults with acute lymphoblastic leukemia who were treated with a pediatric regimen, said Dr. Anna R.K. Franklin of the University of Texas M.D. Anderson Cancer Center in Houston at the annual meeting of the American Society of Hematology. Dr. Franklin and her coauthors hypothesized that survival trends might be similar in acute myeloid leukemia patients.

The researchers compared 281 young adult patients with AML in Children’s Oncology Group (COG) trials, all of whom received a pediatric regimen, vs. 149 young adults in Cancer and Leukemia Group B (CALGB) trials and 87 young adults in Southwest Oncology Group (SWOG) trials, all of whom received an adult regimen. The patients were treated in 1986-2008.

Overall survival 10 years after study entry was 45% in the COG patients vs. 34% in the CALGB/SWOG patients (P less than .05). A subgroup analysis breaking down the combined population by age showed that overall survival after 10 years was 43% in younger patients (aged 16-18 years) vs. 32% in older patients (aged 19-21 years).

The median age was 18 years overall, but the median age in the COG patients was significantly younger than the median age in the CALGB/SWOG patients (17 years vs. 20 years).

The 10-year overall survival rates by age and group were 45% for younger COG patients, 44% for older COG patients, 40% for younger CALGB/SWOG patients, and 31% for older CALGB/SWOG patients.

Overall, the 10-year event-free survival rates were 39% for younger COG patients and 17% for older COG patients vs. 23%, and 22% for younger and older CALGB/SWOG patients, respectively.

In contrast, 10-year treatment-related mortality rates were significantly higher in COG patients than CALGB/SWOG patients. The rates were 26% for younger COG patients and 30% for older COG patients vs. a constant 12% for younger and older CALGB/SWOG patients.

In this study, age was a confounding variable that made comparison of patients on adult vs. child regimens difficult, because 94% of the COG patients were younger than 19 years, Dr. Franklin noted. However, "COG studies have significantly more [treatment-related mortality] and significantly less risk of relapse than the adult trials," she said.

Significant improvements occurred in 10-year overall survival, event-free survival, and relapse risk in more recent studies compared with earlier studies, but treatment-related mortality also increased, said Dr. Franklin. Multivariate analysis of the data is ongoing to determine which specific factors impact patient outcomes in adult vs. pediatric protocols, she said.

Dr. Franklin had no financial conflicts to disclose.

ORLANDO – Ten-year overall survival and event-free survival were significantly higher in adolescents and young adults with acute myeloid leukemia who were treated with a pediatric regimen vs. an adult regimen, based on data from 517 patients aged 16-21 years.

Previous studies have shown improved survival in young adults with acute lymphoblastic leukemia who were treated with a pediatric regimen, said Dr. Anna R.K. Franklin of the University of Texas M.D. Anderson Cancer Center in Houston at the annual meeting of the American Society of Hematology. Dr. Franklin and her coauthors hypothesized that survival trends might be similar in acute myeloid leukemia patients.

The researchers compared 281 young adult patients with AML in Children’s Oncology Group (COG) trials, all of whom received a pediatric regimen, vs. 149 young adults in Cancer and Leukemia Group B (CALGB) trials and 87 young adults in Southwest Oncology Group (SWOG) trials, all of whom received an adult regimen. The patients were treated in 1986-2008.

Overall survival 10 years after study entry was 45% in the COG patients vs. 34% in the CALGB/SWOG patients (P less than .05). A subgroup analysis breaking down the combined population by age showed that overall survival after 10 years was 43% in younger patients (aged 16-18 years) vs. 32% in older patients (aged 19-21 years).

The median age was 18 years overall, but the median age in the COG patients was significantly younger than the median age in the CALGB/SWOG patients (17 years vs. 20 years).

The 10-year overall survival rates by age and group were 45% for younger COG patients, 44% for older COG patients, 40% for younger CALGB/SWOG patients, and 31% for older CALGB/SWOG patients.

Overall, the 10-year event-free survival rates were 39% for younger COG patients and 17% for older COG patients vs. 23%, and 22% for younger and older CALGB/SWOG patients, respectively.

In contrast, 10-year treatment-related mortality rates were significantly higher in COG patients than CALGB/SWOG patients. The rates were 26% for younger COG patients and 30% for older COG patients vs. a constant 12% for younger and older CALGB/SWOG patients.

In this study, age was a confounding variable that made comparison of patients on adult vs. child regimens difficult, because 94% of the COG patients were younger than 19 years, Dr. Franklin noted. However, "COG studies have significantly more [treatment-related mortality] and significantly less risk of relapse than the adult trials," she said.

Significant improvements occurred in 10-year overall survival, event-free survival, and relapse risk in more recent studies compared with earlier studies, but treatment-related mortality also increased, said Dr. Franklin. Multivariate analysis of the data is ongoing to determine which specific factors impact patient outcomes in adult vs. pediatric protocols, she said.

Dr. Franklin had no financial conflicts to disclose.

ORLANDO – Alemtuzumab treatment for 6 weeks following chemotherapy eliminated detectable levels of minimal residual disease in 83% of chronic lymphocytic leukemia patients in a phase II study presented at the annual meeting of the American Society of Hematology.

Previous studies have shown that the length of remission in chronic lymphocytic leukemia (CLL) patients depends on the level of minimal residual disease (MRD) at the end of therapy, regardless of the therapeutic regimen, said Dr. Abraham Varghese of St. James’s University Hospital in Leeds, England. Additional studies have shown that alemtuzumab (Campath) can be used as a consolidation therapy after chemotherapy in these patients, but toxicity remains a concern.

To assess the response of CLL patients to alemtuzumab consolidation, Dr. Varghese and his colleagues in the U.K. National Cancer Research Institute’s CLL trials subgroup conducted the prospective National Cancer Research Network CLL207 trial in 47 patients who received alemtuzumab for at least 6 weeks, starting at 6-24 months after chemotherapy. The patients had undergone one to four previous therapies; 51% had complete responses, and the remaining 49% had partial responses. The average age of the 35 men and 12 women was 58 years. About half had received one prior therapy, and 30% had received two therapies. All but one patient had prior fludarabine. The next most common treatment was rituximab, which nine patients (19%) had received.

Overall, 39 patients (83%) were MRD negative at the end of alemtuzumab treatment. At 6 months after treatment, 20 patients were MRD negative, and at 12 months after treatment, 13 patients remained negative, which suggests improved odds for long-term remission, especially in patients who were MRD negative at 6 weeks.

Prior to alemtuzumab treatment, 24 patients were in complete remission and 23 were in partial remission. In the complete remission group, 22 were MRD negative at the end of treatment, 15 were negative 6 months after treatment, and 8 were negative 12 months after treatment. In the partial remission group, 17 patients were MRD negative at the end of treatment, 5 were negative 6 months after treatment, and 5 were negative 12 months after treatment.

Dr. Varghese reported 351 adverse events, 23 of which were severe. Four patients (9%) experienced unacceptable severe adverse reactions: pneumocystis pneumonia that lasted for 1.3 days; Epstein-Barr virus–driven, high-grade B-cell lymphoma of the bowel leading to hematemesis; parainfluenza leading to death; and EBV-driven, high-grade B-cell lymphoma leading to death. Serious adverse events included 14 infections, 3 hematologic disorders, 2 general disorders and administration site conditions, and 1 cardiovascular disorder, Dr. Varghese said.

Although the toxicity was significant, the study results are encouraging, he said. All 47 patients who received treatment were part of the final analysis. In addition, the target number of patients who were negative for MRD in the study was 14, but 39 patients in the study achieved MRD negativity, he noted.

The results suggest that alemtuzumab consolidation therapy should be further studied in a randomized phase III trial, Dr. Varghese said. A randomized phase III trial will compare alemtuzumab consolidation with observation in CLL patients.

Dr. Varghese had no financial conflicts to disclose. Several of his coauthors disclosed receiving honoraria or research funding, serving on the board of directors or advisory committee, or receiving patent and royalty funds from multiple companies including Genzyme, which makes Campath.

ORLANDO – Alemtuzumab treatment for 6 weeks following chemotherapy eliminated detectable levels of minimal residual disease in 83% of chronic lymphocytic leukemia patients in a phase II study presented at the annual meeting of the American Society of Hematology.

Previous studies have shown that the length of remission in chronic lymphocytic leukemia (CLL) patients depends on the level of minimal residual disease (MRD) at the end of therapy, regardless of the therapeutic regimen, said Dr. Abraham Varghese of St. James’s University Hospital in Leeds, England. Additional studies have shown that alemtuzumab (Campath) can be used as a consolidation therapy after chemotherapy in these patients, but toxicity remains a concern.

To assess the response of CLL patients to alemtuzumab consolidation, Dr. Varghese and his colleagues in the U.K. National Cancer Research Institute’s CLL trials subgroup conducted the prospective National Cancer Research Network CLL207 trial in 47 patients who received alemtuzumab for at least 6 weeks, starting at 6-24 months after chemotherapy. The patients had undergone one to four previous therapies; 51% had complete responses, and the remaining 49% had partial responses. The average age of the 35 men and 12 women was 58 years. About half had received one prior therapy, and 30% had received two therapies. All but one patient had prior fludarabine. The next most common treatment was rituximab, which nine patients (19%) had received.

Overall, 39 patients (83%) were MRD negative at the end of alemtuzumab treatment. At 6 months after treatment, 20 patients were MRD negative, and at 12 months after treatment, 13 patients remained negative, which suggests improved odds for long-term remission, especially in patients who were MRD negative at 6 weeks.

Prior to alemtuzumab treatment, 24 patients were in complete remission and 23 were in partial remission. In the complete remission group, 22 were MRD negative at the end of treatment, 15 were negative 6 months after treatment, and 8 were negative 12 months after treatment. In the partial remission group, 17 patients were MRD negative at the end of treatment, 5 were negative 6 months after treatment, and 5 were negative 12 months after treatment.

Dr. Varghese reported 351 adverse events, 23 of which were severe. Four patients (9%) experienced unacceptable severe adverse reactions: pneumocystis pneumonia that lasted for 1.3 days; Epstein-Barr virus–driven, high-grade B-cell lymphoma of the bowel leading to hematemesis; parainfluenza leading to death; and EBV-driven, high-grade B-cell lymphoma leading to death. Serious adverse events included 14 infections, 3 hematologic disorders, 2 general disorders and administration site conditions, and 1 cardiovascular disorder, Dr. Varghese said.

Although the toxicity was significant, the study results are encouraging, he said. All 47 patients who received treatment were part of the final analysis. In addition, the target number of patients who were negative for MRD in the study was 14, but 39 patients in the study achieved MRD negativity, he noted.

The results suggest that alemtuzumab consolidation therapy should be further studied in a randomized phase III trial, Dr. Varghese said. A randomized phase III trial will compare alemtuzumab consolidation with observation in CLL patients.

Dr. Varghese had no financial conflicts to disclose. Several of his coauthors disclosed receiving honoraria or research funding, serving on the board of directors or advisory committee, or receiving patent and royalty funds from multiple companies including Genzyme, which makes Campath.

ORLANDO – Alemtuzumab treatment for 6 weeks following chemotherapy eliminated detectable levels of minimal residual disease in 83% of chronic lymphocytic leukemia patients in a phase II study presented at the annual meeting of the American Society of Hematology.

Previous studies have shown that the length of remission in chronic lymphocytic leukemia (CLL) patients depends on the level of minimal residual disease (MRD) at the end of therapy, regardless of the therapeutic regimen, said Dr. Abraham Varghese of St. James’s University Hospital in Leeds, England. Additional studies have shown that alemtuzumab (Campath) can be used as a consolidation therapy after chemotherapy in these patients, but toxicity remains a concern.

To assess the response of CLL patients to alemtuzumab consolidation, Dr. Varghese and his colleagues in the U.K. National Cancer Research Institute’s CLL trials subgroup conducted the prospective National Cancer Research Network CLL207 trial in 47 patients who received alemtuzumab for at least 6 weeks, starting at 6-24 months after chemotherapy. The patients had undergone one to four previous therapies; 51% had complete responses, and the remaining 49% had partial responses. The average age of the 35 men and 12 women was 58 years. About half had received one prior therapy, and 30% had received two therapies. All but one patient had prior fludarabine. The next most common treatment was rituximab, which nine patients (19%) had received.

Overall, 39 patients (83%) were MRD negative at the end of alemtuzumab treatment. At 6 months after treatment, 20 patients were MRD negative, and at 12 months after treatment, 13 patients remained negative, which suggests improved odds for long-term remission, especially in patients who were MRD negative at 6 weeks.

Prior to alemtuzumab treatment, 24 patients were in complete remission and 23 were in partial remission. In the complete remission group, 22 were MRD negative at the end of treatment, 15 were negative 6 months after treatment, and 8 were negative 12 months after treatment. In the partial remission group, 17 patients were MRD negative at the end of treatment, 5 were negative 6 months after treatment, and 5 were negative 12 months after treatment.

Dr. Varghese reported 351 adverse events, 23 of which were severe. Four patients (9%) experienced unacceptable severe adverse reactions: pneumocystis pneumonia that lasted for 1.3 days; Epstein-Barr virus–driven, high-grade B-cell lymphoma of the bowel leading to hematemesis; parainfluenza leading to death; and EBV-driven, high-grade B-cell lymphoma leading to death. Serious adverse events included 14 infections, 3 hematologic disorders, 2 general disorders and administration site conditions, and 1 cardiovascular disorder, Dr. Varghese said.

Although the toxicity was significant, the study results are encouraging, he said. All 47 patients who received treatment were part of the final analysis. In addition, the target number of patients who were negative for MRD in the study was 14, but 39 patients in the study achieved MRD negativity, he noted.

The results suggest that alemtuzumab consolidation therapy should be further studied in a randomized phase III trial, Dr. Varghese said. A randomized phase III trial will compare alemtuzumab consolidation with observation in CLL patients.

Dr. Varghese had no financial conflicts to disclose. Several of his coauthors disclosed receiving honoraria or research funding, serving on the board of directors or advisory committee, or receiving patent and royalty funds from multiple companies including Genzyme, which makes Campath.

Certain tobacco products – including cigarettes, roll-your-own, and smokeless varieties – that were introduced or changed in the United States after Feb. 15, 2007, must be reviewed by the U.S. Food and Drug Administration to show that they are "substantially equivalent" to existing products, Dr. Lawrence Deyton, director of the agency’s Center for Tobacco Products, said in a press briefing on Jan. 5.

© kutay tanir/iStockphoto.com

The FDA action is driven by the Family Smoking Prevention and Tobacco Control Act, which became law in June 2009. The law allows the FDA to regulate tobacco products with the goal of protecting public health.

The substantial equivalence provisions are "meant to ensure that new tobacco products or changes to existing products are evaluated by the FDA before they enter the marketplace and are consumed by millions of people," Dr. Deyton said. "Up to now, tobacco products have been the only mass-consumed products for which users do not know what they are consuming," he said.

The Tobacco Control Act allows tobacco companies to market products that were available after Feb. 15, 2007, if the companies submit at least a preliminary report to the FDA by March 22, 2011, to show that these products are not significantly different from pre-existing products. Products in existence before Feb. 15, 2007, are not subject to the new FDA review, said Ann Simoneau, director of the Center for Tobacco Products’ Office of Compliance and Enforcement.

Completely new products introduced after March 22 will follow a different regulatory pathway, Dr. Deyton said.

Physicians should know that the FDA is now examining certain tobacco products and that manufacturers are required to submit information to the FDA about the products and changes to them, "particularly if those changes might raise new questions about public health," Dr. Deyton said.

"FDA’s role does not indicate that these products are safe. There are no tobacco products that are safe," Dr. Deyton emphasized. "The Tobacco Control Act is very clear that this is an important public health tool," he said. "The ingredients of these products have not ever been known to those people who consume them."

"The standard we work under when looking at these products is a public health standard," said David Ashley, Ph.D., director of the Center for Tobacco Products’ Office of Science. "That is at the center of all the decisions we are making," he said. "We will be looking at the possible impact on users and nonusers."

Certain tobacco products – including cigarettes, roll-your-own, and smokeless varieties – that were introduced or changed in the United States after Feb. 15, 2007, must be reviewed by the U.S. Food and Drug Administration to show that they are "substantially equivalent" to existing products, Dr. Lawrence Deyton, director of the agency’s Center for Tobacco Products, said in a press briefing on Jan. 5.

© kutay tanir/iStockphoto.com

The FDA action is driven by the Family Smoking Prevention and Tobacco Control Act, which became law in June 2009. The law allows the FDA to regulate tobacco products with the goal of protecting public health.

The substantial equivalence provisions are "meant to ensure that new tobacco products or changes to existing products are evaluated by the FDA before they enter the marketplace and are consumed by millions of people," Dr. Deyton said. "Up to now, tobacco products have been the only mass-consumed products for which users do not know what they are consuming," he said.

The Tobacco Control Act allows tobacco companies to market products that were available after Feb. 15, 2007, if the companies submit at least a preliminary report to the FDA by March 22, 2011, to show that these products are not significantly different from pre-existing products. Products in existence before Feb. 15, 2007, are not subject to the new FDA review, said Ann Simoneau, director of the Center for Tobacco Products’ Office of Compliance and Enforcement.

Completely new products introduced after March 22 will follow a different regulatory pathway, Dr. Deyton said.

Physicians should know that the FDA is now examining certain tobacco products and that manufacturers are required to submit information to the FDA about the products and changes to them, "particularly if those changes might raise new questions about public health," Dr. Deyton said.

"FDA’s role does not indicate that these products are safe. There are no tobacco products that are safe," Dr. Deyton emphasized. "The Tobacco Control Act is very clear that this is an important public health tool," he said. "The ingredients of these products have not ever been known to those people who consume them."

"The standard we work under when looking at these products is a public health standard," said David Ashley, Ph.D., director of the Center for Tobacco Products’ Office of Science. "That is at the center of all the decisions we are making," he said. "We will be looking at the possible impact on users and nonusers."

Certain tobacco products – including cigarettes, roll-your-own, and smokeless varieties – that were introduced or changed in the United States after Feb. 15, 2007, must be reviewed by the U.S. Food and Drug Administration to show that they are "substantially equivalent" to existing products, Dr. Lawrence Deyton, director of the agency’s Center for Tobacco Products, said in a press briefing on Jan. 5.

© kutay tanir/iStockphoto.com

The FDA action is driven by the Family Smoking Prevention and Tobacco Control Act, which became law in June 2009. The law allows the FDA to regulate tobacco products with the goal of protecting public health.

The substantial equivalence provisions are "meant to ensure that new tobacco products or changes to existing products are evaluated by the FDA before they enter the marketplace and are consumed by millions of people," Dr. Deyton said. "Up to now, tobacco products have been the only mass-consumed products for which users do not know what they are consuming," he said.

The Tobacco Control Act allows tobacco companies to market products that were available after Feb. 15, 2007, if the companies submit at least a preliminary report to the FDA by March 22, 2011, to show that these products are not significantly different from pre-existing products. Products in existence before Feb. 15, 2007, are not subject to the new FDA review, said Ann Simoneau, director of the Center for Tobacco Products’ Office of Compliance and Enforcement.

Completely new products introduced after March 22 will follow a different regulatory pathway, Dr. Deyton said.

Physicians should know that the FDA is now examining certain tobacco products and that manufacturers are required to submit information to the FDA about the products and changes to them, "particularly if those changes might raise new questions about public health," Dr. Deyton said.

"FDA’s role does not indicate that these products are safe. There are no tobacco products that are safe," Dr. Deyton emphasized. "The Tobacco Control Act is very clear that this is an important public health tool," he said. "The ingredients of these products have not ever been known to those people who consume them."

"The standard we work under when looking at these products is a public health standard," said David Ashley, Ph.D., director of the Center for Tobacco Products’ Office of Science. "That is at the center of all the decisions we are making," he said. "We will be looking at the possible impact on users and nonusers."

Certain tobacco products – including cigarettes, roll-your-own, and smokeless varieties – that were introduced or changed in the United States after Feb. 15, 2007, must be reviewed by the U.S. Food and Drug Administration to show that they are "substantially equivalent" to existing products, Dr. Lawrence Deyton, director of the agency’s Center for Tobacco Products, said in a press briefing on Jan. 5.

© kutay tanir/iStockphoto.com

The FDA action is driven by the Family Smoking Prevention and Tobacco Control Act, which became law in June 2009. The law allows the FDA to regulate tobacco products with the goal of protecting public health.

The substantial equivalence provisions are "meant to ensure that new tobacco products or changes to existing products are evaluated by the FDA before they enter the marketplace and are consumed by millions of people," Dr. Deyton said. "Up to now, tobacco products have been the only mass-consumed products for which users do not know what they are consuming," he said.

The Tobacco Control Act allows tobacco companies to market products that were available after Feb. 15, 2007, if the companies submit at least a preliminary report to the FDA by March 22, 2011, to show that these products are not significantly different from pre-existing products. Products in existence before Feb. 15, 2007, are not subject to the new FDA review, said Ann Simoneau, director of the Center for Tobacco Products’ Office of Compliance and Enforcement.

Completely new products introduced after March 22 will follow a different regulatory pathway, Dr. Deyton said.

Physicians should know that the FDA is now examining certain tobacco products and that manufacturers are required to submit information to the FDA about the products and changes to them, "particularly if those changes might raise new questions about public health," Dr. Deyton said.

"FDA’s role does not indicate that these products are safe. There are no tobacco products that are safe," Dr. Deyton emphasized. "The Tobacco Control Act is very clear that this is an important public health tool," he said. "The ingredients of these products have not ever been known to those people who consume them."

"The standard we work under when looking at these products is a public health standard," said David Ashley, Ph.D., director of the Center for Tobacco Products’ Office of Science. "That is at the center of all the decisions we are making," he said. "We will be looking at the possible impact on users and nonusers."

Certain tobacco products – including cigarettes, roll-your-own, and smokeless varieties – that were introduced or changed in the United States after Feb. 15, 2007, must be reviewed by the U.S. Food and Drug Administration to show that they are "substantially equivalent" to existing products, Dr. Lawrence Deyton, director of the agency’s Center for Tobacco Products, said in a press briefing on Jan. 5.

© kutay tanir/iStockphoto.com

The FDA action is driven by the Family Smoking Prevention and Tobacco Control Act, which became law in June 2009. The law allows the FDA to regulate tobacco products with the goal of protecting public health.

The substantial equivalence provisions are "meant to ensure that new tobacco products or changes to existing products are evaluated by the FDA before they enter the marketplace and are consumed by millions of people," Dr. Deyton said. "Up to now, tobacco products have been the only mass-consumed products for which users do not know what they are consuming," he said.

The Tobacco Control Act allows tobacco companies to market products that were available after Feb. 15, 2007, if the companies submit at least a preliminary report to the FDA by March 22, 2011, to show that these products are not significantly different from pre-existing products. Products in existence before Feb. 15, 2007, are not subject to the new FDA review, said Ann Simoneau, director of the Center for Tobacco Products’ Office of Compliance and Enforcement.

Completely new products introduced after March 22 will follow a different regulatory pathway, Dr. Deyton said.

Physicians should know that the FDA is now examining certain tobacco products and that manufacturers are required to submit information to the FDA about the products and changes to them, "particularly if those changes might raise new questions about public health," Dr. Deyton said.

"FDA’s role does not indicate that these products are safe. There are no tobacco products that are safe," Dr. Deyton emphasized. "The Tobacco Control Act is very clear that this is an important public health tool," he said. "The ingredients of these products have not ever been known to those people who consume them."

"The standard we work under when looking at these products is a public health standard," said David Ashley, Ph.D., director of the Center for Tobacco Products’ Office of Science. "That is at the center of all the decisions we are making," he said. "We will be looking at the possible impact on users and nonusers."

Certain tobacco products – including cigarettes, roll-your-own, and smokeless varieties – that were introduced or changed in the United States after Feb. 15, 2007, must be reviewed by the U.S. Food and Drug Administration to show that they are "substantially equivalent" to existing products, Dr. Lawrence Deyton, director of the agency’s Center for Tobacco Products, said in a press briefing on Jan. 5.

© kutay tanir/iStockphoto.com

The FDA action is driven by the Family Smoking Prevention and Tobacco Control Act, which became law in June 2009. The law allows the FDA to regulate tobacco products with the goal of protecting public health.

The substantial equivalence provisions are "meant to ensure that new tobacco products or changes to existing products are evaluated by the FDA before they enter the marketplace and are consumed by millions of people," Dr. Deyton said. "Up to now, tobacco products have been the only mass-consumed products for which users do not know what they are consuming," he said.

The Tobacco Control Act allows tobacco companies to market products that were available after Feb. 15, 2007, if the companies submit at least a preliminary report to the FDA by March 22, 2011, to show that these products are not significantly different from pre-existing products. Products in existence before Feb. 15, 2007, are not subject to the new FDA review, said Ann Simoneau, director of the Center for Tobacco Products’ Office of Compliance and Enforcement.

Completely new products introduced after March 22 will follow a different regulatory pathway, Dr. Deyton said.

Physicians should know that the FDA is now examining certain tobacco products and that manufacturers are required to submit information to the FDA about the products and changes to them, "particularly if those changes might raise new questions about public health," Dr. Deyton said.

"FDA’s role does not indicate that these products are safe. There are no tobacco products that are safe," Dr. Deyton emphasized. "The Tobacco Control Act is very clear that this is an important public health tool," he said. "The ingredients of these products have not ever been known to those people who consume them."

"The standard we work under when looking at these products is a public health standard," said David Ashley, Ph.D., director of the Center for Tobacco Products’ Office of Science. "That is at the center of all the decisions we are making," he said. "We will be looking at the possible impact on users and nonusers."

Major Finding: Among adults with colorectal adenomas at baseline, obese patients had a 20% increased risk of recurrent adenomas and overweight patients had an 18% increased risk during a mean follow-up of 8.4 years.

Data Source: Long-term follow-up in a prospective study of 760 adults.

Disclosures: Dr. Laiyemo had no financial conflicts to disclose.

SAN ANTONIO – Overweight and obese adults had an increased risk of recurrent adenomas during short-term and long-term follow-up, based on data from patients with colorectal adenomas at baseline.

Previous studies have shown a short-term association between obesity and increased risk of adenoma recurrence, said Dr. Adeyinka Laiyemo of Howard University in Washington. To assess the long-term impact of overweight and obesity on adenoma risk, Dr. Laiyemo and colleagues reviewed data from participants in the Polyp Prevention Trial, a multicenter study of the effect of a low-fat, high-fiber diet on adenoma recurrence. The results were presented at the meeting.

Upon completion of the 4-year (short-term) study, a subset of 760 participants agreed to continue in an extended, passive long-term follow-up without dietary restrictions. Their colonoscopy reports were analyzed for up to 12 years, with an average follow-up period of 8.4 years.

During the long-term follow-up, obese patients had a significant 20% increase in risk for any adenoma and a 25% non-significant increase in risk for an advanced adenoma, compared with patients of normal weight. Overweight patients had an 18% significant increase in risk of any adenoma and a 14% non-significant increase in risk of advanced adenoma, compared with normal-weight patients.

Analysis of the initial 4-year follow-up period also showed increased risk for participants with excess body weight. Obese patients had a 19% increase in risk for any adenoma and a 23% increase in risk for advanced adenoma compared with normal-weight patients, although neither of these were statistically significant. Overweight patients had a 23% significant increase in risk for any adenoma and a 18% nonsignificant increase in risk for advanced adenomas compared with normal-weight patients during the 4-year period.

The average age of the participants was 60 years, and 66% were men. Approximately 25% of the participants were of normal weight (body mass index less than 25 kg/m

“This suggests that lifestyle modification should be encouraged,” Dr. Laiyemo said. The study was strengthened by the inclusion of patients from eight different centers, but was limited by the lack of data on morbidly obese patients, he added.

More research is needed to determine whether overweight or obese patients with baseline polyps should be reexamined more frequently than normal-weight patients. For now, however, if these patients have baseline polyps, they need to know that their risk for recurrent adenomas is increased, Dr. Amy E. Foxx-Orenstein of the Mayo Clinic, Scottsdale, Ariz., said at a press conference.

Another message that patients need to hear is that a good prep is important, to get the best possible information from each colonoscopy, Dr. David A. Johnson of Eastern Virginia School of Medicine, Norfolk, said at the press conference.

Major Finding: Among adults with colorectal adenomas at baseline, obese patients had a 20% increased risk of recurrent adenomas and overweight patients had an 18% increased risk during a mean follow-up of 8.4 years.

Data Source: Long-term follow-up in a prospective study of 760 adults.

Disclosures: Dr. Laiyemo had no financial conflicts to disclose.

SAN ANTONIO – Overweight and obese adults had an increased risk of recurrent adenomas during short-term and long-term follow-up, based on data from patients with colorectal adenomas at baseline.

Previous studies have shown a short-term association between obesity and increased risk of adenoma recurrence, said Dr. Adeyinka Laiyemo of Howard University in Washington. To assess the long-term impact of overweight and obesity on adenoma risk, Dr. Laiyemo and colleagues reviewed data from participants in the Polyp Prevention Trial, a multicenter study of the effect of a low-fat, high-fiber diet on adenoma recurrence. The results were presented at the meeting.

Upon completion of the 4-year (short-term) study, a subset of 760 participants agreed to continue in an extended, passive long-term follow-up without dietary restrictions. Their colonoscopy reports were analyzed for up to 12 years, with an average follow-up period of 8.4 years.

During the long-term follow-up, obese patients had a significant 20% increase in risk for any adenoma and a 25% non-significant increase in risk for an advanced adenoma, compared with patients of normal weight. Overweight patients had an 18% significant increase in risk of any adenoma and a 14% non-significant increase in risk of advanced adenoma, compared with normal-weight patients.

Analysis of the initial 4-year follow-up period also showed increased risk for participants with excess body weight. Obese patients had a 19% increase in risk for any adenoma and a 23% increase in risk for advanced adenoma compared with normal-weight patients, although neither of these were statistically significant. Overweight patients had a 23% significant increase in risk for any adenoma and a 18% nonsignificant increase in risk for advanced adenomas compared with normal-weight patients during the 4-year period.

The average age of the participants was 60 years, and 66% were men. Approximately 25% of the participants were of normal weight (body mass index less than 25 kg/m

“This suggests that lifestyle modification should be encouraged,” Dr. Laiyemo said. The study was strengthened by the inclusion of patients from eight different centers, but was limited by the lack of data on morbidly obese patients, he added.

More research is needed to determine whether overweight or obese patients with baseline polyps should be reexamined more frequently than normal-weight patients. For now, however, if these patients have baseline polyps, they need to know that their risk for recurrent adenomas is increased, Dr. Amy E. Foxx-Orenstein of the Mayo Clinic, Scottsdale, Ariz., said at a press conference.

Another message that patients need to hear is that a good prep is important, to get the best possible information from each colonoscopy, Dr. David A. Johnson of Eastern Virginia School of Medicine, Norfolk, said at the press conference.

Major Finding: Among adults with colorectal adenomas at baseline, obese patients had a 20% increased risk of recurrent adenomas and overweight patients had an 18% increased risk during a mean follow-up of 8.4 years.

Data Source: Long-term follow-up in a prospective study of 760 adults.

Disclosures: Dr. Laiyemo had no financial conflicts to disclose.

SAN ANTONIO – Overweight and obese adults had an increased risk of recurrent adenomas during short-term and long-term follow-up, based on data from patients with colorectal adenomas at baseline.

Previous studies have shown a short-term association between obesity and increased risk of adenoma recurrence, said Dr. Adeyinka Laiyemo of Howard University in Washington. To assess the long-term impact of overweight and obesity on adenoma risk, Dr. Laiyemo and colleagues reviewed data from participants in the Polyp Prevention Trial, a multicenter study of the effect of a low-fat, high-fiber diet on adenoma recurrence. The results were presented at the meeting.

Upon completion of the 4-year (short-term) study, a subset of 760 participants agreed to continue in an extended, passive long-term follow-up without dietary restrictions. Their colonoscopy reports were analyzed for up to 12 years, with an average follow-up period of 8.4 years.

During the long-term follow-up, obese patients had a significant 20% increase in risk for any adenoma and a 25% non-significant increase in risk for an advanced adenoma, compared with patients of normal weight. Overweight patients had an 18% significant increase in risk of any adenoma and a 14% non-significant increase in risk of advanced adenoma, compared with normal-weight patients.

Analysis of the initial 4-year follow-up period also showed increased risk for participants with excess body weight. Obese patients had a 19% increase in risk for any adenoma and a 23% increase in risk for advanced adenoma compared with normal-weight patients, although neither of these were statistically significant. Overweight patients had a 23% significant increase in risk for any adenoma and a 18% nonsignificant increase in risk for advanced adenomas compared with normal-weight patients during the 4-year period.

The average age of the participants was 60 years, and 66% were men. Approximately 25% of the participants were of normal weight (body mass index less than 25 kg/m

“This suggests that lifestyle modification should be encouraged,” Dr. Laiyemo said. The study was strengthened by the inclusion of patients from eight different centers, but was limited by the lack of data on morbidly obese patients, he added.

More research is needed to determine whether overweight or obese patients with baseline polyps should be reexamined more frequently than normal-weight patients. For now, however, if these patients have baseline polyps, they need to know that their risk for recurrent adenomas is increased, Dr. Amy E. Foxx-Orenstein of the Mayo Clinic, Scottsdale, Ariz., said at a press conference.

Another message that patients need to hear is that a good prep is important, to get the best possible information from each colonoscopy, Dr. David A. Johnson of Eastern Virginia School of Medicine, Norfolk, said at the press conference.

Major Finding: TNF inhibitor use was associated with a 60% reduction in the risk of developing diabetes.

Data Source: Data from 1,287 adults with nonincident RA.

Disclosures: Dr. Antohe said that she had no financial conflicts to disclose. Several of her co-investigators have received research grants from pharmaceutical companies including Wyeth, Amgen, and Centocor.

ATLANTA — Use of tumor necrosis factor inhibitors reduced the risk of developing type 2 diabetes by 60%, based on data from 1,287 nondiabetic adults with rheumatoid arthritis.

“Interventions that treat RA and improve insulin resistance are highly desirable,” said Dr. Jana Antohe of Geisinger Health System in Danville, Penn.

To examine the impact of TNF inhibitor use in RA patients, Dr. Antohe and her colleagues followed 1,287 incident RA patients who were identified during January 2001–March 2008 at a rural tertiary health center.

Of the 1,539 RA patients identified, 252 with preexisting diabetes were excluded.

The researchers compared the 884 patients who had never used TNF inhibitors with the 403 patients who had ever used them.

Patients in the ever-use group had a higher median body mass index and C-reactive protein (CRP) level than did the never-use group, but these differences were not significant.

After a median follow-up time of 35 months for the ever users and 23 months for the never users, the researchers identified 13 new cases of diabetes in the ever-use group and 43 in the never-use group, for incidence rates of 11/1,000 person-years and 22/1,000 person-years, respectively, according to the researcher.

The median age of the patients was 61 years, the median BMI was 28.6 kg/m

The findings were adjusted for gender, age, race, hypertension, BMI, positive rheumatoid factor and anti-cyclic citrullinated peptide (anti-CCP) levels, erythrocyte sedimentation rate, CRP levels, and the use of NSAIDs, glucocorticoids, hydroxychloroquine, and methotrexate.

Additional research is needed to confirm the findings in patients at increased risk for cardiovascular disease, Dr. Antohe said.

Major Finding: TNF inhibitor use was associated with a 60% reduction in the risk of developing diabetes.

Data Source: Data from 1,287 adults with nonincident RA.

Disclosures: Dr. Antohe said that she had no financial conflicts to disclose. Several of her co-investigators have received research grants from pharmaceutical companies including Wyeth, Amgen, and Centocor.

ATLANTA — Use of tumor necrosis factor inhibitors reduced the risk of developing type 2 diabetes by 60%, based on data from 1,287 nondiabetic adults with rheumatoid arthritis.

“Interventions that treat RA and improve insulin resistance are highly desirable,” said Dr. Jana Antohe of Geisinger Health System in Danville, Penn.

To examine the impact of TNF inhibitor use in RA patients, Dr. Antohe and her colleagues followed 1,287 incident RA patients who were identified during January 2001–March 2008 at a rural tertiary health center.

Of the 1,539 RA patients identified, 252 with preexisting diabetes were excluded.

The researchers compared the 884 patients who had never used TNF inhibitors with the 403 patients who had ever used them.

Patients in the ever-use group had a higher median body mass index and C-reactive protein (CRP) level than did the never-use group, but these differences were not significant.

After a median follow-up time of 35 months for the ever users and 23 months for the never users, the researchers identified 13 new cases of diabetes in the ever-use group and 43 in the never-use group, for incidence rates of 11/1,000 person-years and 22/1,000 person-years, respectively, according to the researcher.

The median age of the patients was 61 years, the median BMI was 28.6 kg/m

The findings were adjusted for gender, age, race, hypertension, BMI, positive rheumatoid factor and anti-cyclic citrullinated peptide (anti-CCP) levels, erythrocyte sedimentation rate, CRP levels, and the use of NSAIDs, glucocorticoids, hydroxychloroquine, and methotrexate.

Additional research is needed to confirm the findings in patients at increased risk for cardiovascular disease, Dr. Antohe said.

Major Finding: TNF inhibitor use was associated with a 60% reduction in the risk of developing diabetes.

Data Source: Data from 1,287 adults with nonincident RA.

Disclosures: Dr. Antohe said that she had no financial conflicts to disclose. Several of her co-investigators have received research grants from pharmaceutical companies including Wyeth, Amgen, and Centocor.

ATLANTA — Use of tumor necrosis factor inhibitors reduced the risk of developing type 2 diabetes by 60%, based on data from 1,287 nondiabetic adults with rheumatoid arthritis.

“Interventions that treat RA and improve insulin resistance are highly desirable,” said Dr. Jana Antohe of Geisinger Health System in Danville, Penn.

To examine the impact of TNF inhibitor use in RA patients, Dr. Antohe and her colleagues followed 1,287 incident RA patients who were identified during January 2001–March 2008 at a rural tertiary health center.

Of the 1,539 RA patients identified, 252 with preexisting diabetes were excluded.

The researchers compared the 884 patients who had never used TNF inhibitors with the 403 patients who had ever used them.

Patients in the ever-use group had a higher median body mass index and C-reactive protein (CRP) level than did the never-use group, but these differences were not significant.

After a median follow-up time of 35 months for the ever users and 23 months for the never users, the researchers identified 13 new cases of diabetes in the ever-use group and 43 in the never-use group, for incidence rates of 11/1,000 person-years and 22/1,000 person-years, respectively, according to the researcher.

The median age of the patients was 61 years, the median BMI was 28.6 kg/m

The findings were adjusted for gender, age, race, hypertension, BMI, positive rheumatoid factor and anti-cyclic citrullinated peptide (anti-CCP) levels, erythrocyte sedimentation rate, CRP levels, and the use of NSAIDs, glucocorticoids, hydroxychloroquine, and methotrexate.

Additional research is needed to confirm the findings in patients at increased risk for cardiovascular disease, Dr. Antohe said.

Major Finding: TNF-inhibitor users reduced the average sick leave time from 9.8 days per month at the start of treatment to 6.5 days after 6 months of treatment.

Data Source: A study of 365 Swedish adults aged 18-58 years with rheumatoid arthritis

Disclosures: The researchers said that they had no relevant financial disclosures.

A significant 30% reduction in the number of sick leave days per month was seen in adults with rheumatoid arthritis after using TNF antagonists for 6 months.

The finding was observed in a population-based study of 365 RA patients aged 18-85 years.

The study is among the first to address the quantitative impact of TNF inhibitors on sick leave and disability pension, said Dr. Tor Olofsson of Lund (Sweden) University, and colleagues, whose study was published in the December issue of Annals of the Rheumatic Diseases.

They reviewed insurance database information on RA patients enrolled in the South Swedish Arthritis Treatment Group registry.

Each patient was matched with four controls from the general population.

The study population averaged 9 sick days per month in the first month of anti-TNF treatment. The monthly rate dropped to an average of 6.5 days after 6 months and remained steady at an average of 6.6 days per month for months 6-12 (Ann. Rheum. Dis. 2010;69:2131-6).

Compared with the controls in the general population, the relative risk of being on sick leave in the RA group was 6.6 at the start of treatment, but dropped to 5.1 after 6 months, and remained at an average of 5.2 for the rest of the year. The relative risk of being on disability pension was 3.4 at the start of treatment and 3.2 after one year of treatment.

Approximately 98% of the patients had tried at least one disease-modifying antirheumatic drug (DMARD) before starting anti-TNF therapy.

The average age of the patients was 46 years, and 82% were women. A total of 92 patients (25%) discontinued treatment, including 34 for adverse events, 32 for treatment failure, and 26 for other reasons.

Major Finding: TNF-inhibitor users reduced the average sick leave time from 9.8 days per month at the start of treatment to 6.5 days after 6 months of treatment.

Data Source: A study of 365 Swedish adults aged 18-58 years with rheumatoid arthritis

Disclosures: The researchers said that they had no relevant financial disclosures.

A significant 30% reduction in the number of sick leave days per month was seen in adults with rheumatoid arthritis after using TNF antagonists for 6 months.

The finding was observed in a population-based study of 365 RA patients aged 18-85 years.

The study is among the first to address the quantitative impact of TNF inhibitors on sick leave and disability pension, said Dr. Tor Olofsson of Lund (Sweden) University, and colleagues, whose study was published in the December issue of Annals of the Rheumatic Diseases.

They reviewed insurance database information on RA patients enrolled in the South Swedish Arthritis Treatment Group registry.

Each patient was matched with four controls from the general population.

The study population averaged 9 sick days per month in the first month of anti-TNF treatment. The monthly rate dropped to an average of 6.5 days after 6 months and remained steady at an average of 6.6 days per month for months 6-12 (Ann. Rheum. Dis. 2010;69:2131-6).

Compared with the controls in the general population, the relative risk of being on sick leave in the RA group was 6.6 at the start of treatment, but dropped to 5.1 after 6 months, and remained at an average of 5.2 for the rest of the year. The relative risk of being on disability pension was 3.4 at the start of treatment and 3.2 after one year of treatment.

Approximately 98% of the patients had tried at least one disease-modifying antirheumatic drug (DMARD) before starting anti-TNF therapy.

The average age of the patients was 46 years, and 82% were women. A total of 92 patients (25%) discontinued treatment, including 34 for adverse events, 32 for treatment failure, and 26 for other reasons.

Major Finding: TNF-inhibitor users reduced the average sick leave time from 9.8 days per month at the start of treatment to 6.5 days after 6 months of treatment.

Data Source: A study of 365 Swedish adults aged 18-58 years with rheumatoid arthritis

Disclosures: The researchers said that they had no relevant financial disclosures.

A significant 30% reduction in the number of sick leave days per month was seen in adults with rheumatoid arthritis after using TNF antagonists for 6 months.

The finding was observed in a population-based study of 365 RA patients aged 18-85 years.

The study is among the first to address the quantitative impact of TNF inhibitors on sick leave and disability pension, said Dr. Tor Olofsson of Lund (Sweden) University, and colleagues, whose study was published in the December issue of Annals of the Rheumatic Diseases.

They reviewed insurance database information on RA patients enrolled in the South Swedish Arthritis Treatment Group registry.

Each patient was matched with four controls from the general population.

The study population averaged 9 sick days per month in the first month of anti-TNF treatment. The monthly rate dropped to an average of 6.5 days after 6 months and remained steady at an average of 6.6 days per month for months 6-12 (Ann. Rheum. Dis. 2010;69:2131-6).

Compared with the controls in the general population, the relative risk of being on sick leave in the RA group was 6.6 at the start of treatment, but dropped to 5.1 after 6 months, and remained at an average of 5.2 for the rest of the year. The relative risk of being on disability pension was 3.4 at the start of treatment and 3.2 after one year of treatment.

Approximately 98% of the patients had tried at least one disease-modifying antirheumatic drug (DMARD) before starting anti-TNF therapy.

The average age of the patients was 46 years, and 82% were women. A total of 92 patients (25%) discontinued treatment, including 34 for adverse events, 32 for treatment failure, and 26 for other reasons.

Major Finding: Of adults younger than age 60 years who have bunions, 89% inherited the condition.

Data Source: A genetic analysis and foot examination of 2,179 adults.

Disclosures: Dr. Hannan had no financial conflicts to disclose.

ATLANTA — Got bunions? Thank your parents. Bunions were inherited in 89% of adults younger than 60 years, according to genetic data from more than 2,000 adults.

Bunions and other foot disorders can limit mobility and exacerbate other musculoskeletal weaknesses, but interventions are available, and they are most effective if foot deformities are identified early, said Marian Hannan, D.Sc., of Harvard Medicalxd

School, Boston.

Foot disorders occur in 20%-60% of adults, and researchers have long suspected genetic involvement, but this study is the first to examine specific associations between genes and foot deformities, Dr. Hannan said.

Dr. Hannan and her colleagues reviewed data from 959 men and 1,220 women in the Framingham Foot Study of 2002-2005. A trained examiner evaluated the study participants for any of 20 different foot disorders. In this study, Dr. Hannan reported data about the most common and least common of the disorders: hallux valgus (bunions) and pes cavus (high arches).

Overall, 675 individuals (31%) had bunions and 154 (7%) had high arches. A bunion was defined as a big toe angled at least 15 degrees toward the first metatarsal. High arches were identified by calculating weight-bearing arch width.

The researchers used statistical genetics software to determine the heritability of the two conditions. Across all ages, 39% of women and 38% of men inherited their bunions, and 68% of women and 20% of men inherited their high arches. Among individuals younger than 60 years, 99% of women and 63% of men inherited their high arches. The heritability estimates were statistically significant for both conditions. Participants' average age was 66 years, and 57% were women.

Major Finding: Of adults younger than age 60 years who have bunions, 89% inherited the condition.

Data Source: A genetic analysis and foot examination of 2,179 adults.

Disclosures: Dr. Hannan had no financial conflicts to disclose.

ATLANTA — Got bunions? Thank your parents. Bunions were inherited in 89% of adults younger than 60 years, according to genetic data from more than 2,000 adults.

Bunions and other foot disorders can limit mobility and exacerbate other musculoskeletal weaknesses, but interventions are available, and they are most effective if foot deformities are identified early, said Marian Hannan, D.Sc., of Harvard Medicalxd

School, Boston.

Foot disorders occur in 20%-60% of adults, and researchers have long suspected genetic involvement, but this study is the first to examine specific associations between genes and foot deformities, Dr. Hannan said.

Dr. Hannan and her colleagues reviewed data from 959 men and 1,220 women in the Framingham Foot Study of 2002-2005. A trained examiner evaluated the study participants for any of 20 different foot disorders. In this study, Dr. Hannan reported data about the most common and least common of the disorders: hallux valgus (bunions) and pes cavus (high arches).

Overall, 675 individuals (31%) had bunions and 154 (7%) had high arches. A bunion was defined as a big toe angled at least 15 degrees toward the first metatarsal. High arches were identified by calculating weight-bearing arch width.

The researchers used statistical genetics software to determine the heritability of the two conditions. Across all ages, 39% of women and 38% of men inherited their bunions, and 68% of women and 20% of men inherited their high arches. Among individuals younger than 60 years, 99% of women and 63% of men inherited their high arches. The heritability estimates were statistically significant for both conditions. Participants' average age was 66 years, and 57% were women.

Major Finding: Of adults younger than age 60 years who have bunions, 89% inherited the condition.

Data Source: A genetic analysis and foot examination of 2,179 adults.

Disclosures: Dr. Hannan had no financial conflicts to disclose.

ATLANTA — Got bunions? Thank your parents. Bunions were inherited in 89% of adults younger than 60 years, according to genetic data from more than 2,000 adults.

Bunions and other foot disorders can limit mobility and exacerbate other musculoskeletal weaknesses, but interventions are available, and they are most effective if foot deformities are identified early, said Marian Hannan, D.Sc., of Harvard Medicalxd

School, Boston.

Foot disorders occur in 20%-60% of adults, and researchers have long suspected genetic involvement, but this study is the first to examine specific associations between genes and foot deformities, Dr. Hannan said.

Dr. Hannan and her colleagues reviewed data from 959 men and 1,220 women in the Framingham Foot Study of 2002-2005. A trained examiner evaluated the study participants for any of 20 different foot disorders. In this study, Dr. Hannan reported data about the most common and least common of the disorders: hallux valgus (bunions) and pes cavus (high arches).

Overall, 675 individuals (31%) had bunions and 154 (7%) had high arches. A bunion was defined as a big toe angled at least 15 degrees toward the first metatarsal. High arches were identified by calculating weight-bearing arch width.

The researchers used statistical genetics software to determine the heritability of the two conditions. Across all ages, 39% of women and 38% of men inherited their bunions, and 68% of women and 20% of men inherited their high arches. Among individuals younger than 60 years, 99% of women and 63% of men inherited their high arches. The heritability estimates were statistically significant for both conditions. Participants' average age was 66 years, and 57% were women.

Major Finding: In 20% of patients first seen in primary care settings, axial spondyloarthritis was the cause of chronic low back pain.

Data Source: A cross-sectional study of 364 adults aged 19-45 years with chronic back pain.

Disclosures: Dr. Weel said that she had no financial conflicts.

ATLANTA — Approximately 20% of cases of chronic low back pain in younger adults seen in primary care settings might be caused by spondyloarthritis, based on data from 364 patients aged 19-45 years.

In the cross-sectional study, 77 of 364 patients (22%) met the diagnosis of axial spondyloarthritis on examination by a rheumatologist. The average age of the patients was 36 years, 43% were male, and the average duration of chronic low back pain was 9 years.

The diagnostic techniques included a detailed patient questionnaire about inflammatory back pain, physical examination, and patient history; blood tests to assess C-reactive protein levels and the presence of HLA-B27 (a gene that has been linked to spondyloarthritis); and conventional and MRI images of sacroiliac joints. Two radiologists reviewed the images for the signs of inflammation and bone lesions that might indicate axial spondyloarthritis.

Fifty-two patients were diagnosed according to MRI criteria plus one additional spondyloarthritis feature. The other 12 patients were diagnosed according to a positive HLA-B27 test plus two additional spondyloarthritis features, said Dr. Angelique Weel of Maasstad Ziekenhuis, Rotterdam, the Netherlands. In addition, 24 patients (6.6%) met the criteria for ankylosing spondylitis.

The results suggest that spondyloarthritis is underdiagnosed as a cause of chronic back pain in the general population. Dr. Weel recommended that primary care physicians suspect spondyloarthritis when they see younger adults with chronic back pain, and refer these patients to a rheumatologist if they suspect an inflammatory basis for the pain.

“We also tried to make a simple questionnaire for general practitioners, so they can determine which patient with chronic low back pain should be sent to a rheumatologist to investigate possible spondyloarthritis,” she noted. Possible red flags on the questionnaire include the response to NSAIDs and a family history of spondyloarthritis, Dr. Weel said.

Dr. Weel speaks about spondyloarthritis in a video interview posted at

Source Heidi Spleet/Elsevier Global Medical Newswww.rheumatologynews.com

Major Finding: In 20% of patients first seen in primary care settings, axial spondyloarthritis was the cause of chronic low back pain.

Data Source: A cross-sectional study of 364 adults aged 19-45 years with chronic back pain.

Disclosures: Dr. Weel said that she had no financial conflicts.

ATLANTA — Approximately 20% of cases of chronic low back pain in younger adults seen in primary care settings might be caused by spondyloarthritis, based on data from 364 patients aged 19-45 years.

In the cross-sectional study, 77 of 364 patients (22%) met the diagnosis of axial spondyloarthritis on examination by a rheumatologist. The average age of the patients was 36 years, 43% were male, and the average duration of chronic low back pain was 9 years.

The diagnostic techniques included a detailed patient questionnaire about inflammatory back pain, physical examination, and patient history; blood tests to assess C-reactive protein levels and the presence of HLA-B27 (a gene that has been linked to spondyloarthritis); and conventional and MRI images of sacroiliac joints. Two radiologists reviewed the images for the signs of inflammation and bone lesions that might indicate axial spondyloarthritis.

Fifty-two patients were diagnosed according to MRI criteria plus one additional spondyloarthritis feature. The other 12 patients were diagnosed according to a positive HLA-B27 test plus two additional spondyloarthritis features, said Dr. Angelique Weel of Maasstad Ziekenhuis, Rotterdam, the Netherlands. In addition, 24 patients (6.6%) met the criteria for ankylosing spondylitis.

The results suggest that spondyloarthritis is underdiagnosed as a cause of chronic back pain in the general population. Dr. Weel recommended that primary care physicians suspect spondyloarthritis when they see younger adults with chronic back pain, and refer these patients to a rheumatologist if they suspect an inflammatory basis for the pain.

“We also tried to make a simple questionnaire for general practitioners, so they can determine which patient with chronic low back pain should be sent to a rheumatologist to investigate possible spondyloarthritis,” she noted. Possible red flags on the questionnaire include the response to NSAIDs and a family history of spondyloarthritis, Dr. Weel said.

Dr. Weel speaks about spondyloarthritis in a video interview posted at

Source Heidi Spleet/Elsevier Global Medical Newswww.rheumatologynews.com

Major Finding: In 20% of patients first seen in primary care settings, axial spondyloarthritis was the cause of chronic low back pain.

Data Source: A cross-sectional study of 364 adults aged 19-45 years with chronic back pain.

Disclosures: Dr. Weel said that she had no financial conflicts.

ATLANTA — Approximately 20% of cases of chronic low back pain in younger adults seen in primary care settings might be caused by spondyloarthritis, based on data from 364 patients aged 19-45 years.

In the cross-sectional study, 77 of 364 patients (22%) met the diagnosis of axial spondyloarthritis on examination by a rheumatologist. The average age of the patients was 36 years, 43% were male, and the average duration of chronic low back pain was 9 years.

The diagnostic techniques included a detailed patient questionnaire about inflammatory back pain, physical examination, and patient history; blood tests to assess C-reactive protein levels and the presence of HLA-B27 (a gene that has been linked to spondyloarthritis); and conventional and MRI images of sacroiliac joints. Two radiologists reviewed the images for the signs of inflammation and bone lesions that might indicate axial spondyloarthritis.

Fifty-two patients were diagnosed according to MRI criteria plus one additional spondyloarthritis feature. The other 12 patients were diagnosed according to a positive HLA-B27 test plus two additional spondyloarthritis features, said Dr. Angelique Weel of Maasstad Ziekenhuis, Rotterdam, the Netherlands. In addition, 24 patients (6.6%) met the criteria for ankylosing spondylitis.

The results suggest that spondyloarthritis is underdiagnosed as a cause of chronic back pain in the general population. Dr. Weel recommended that primary care physicians suspect spondyloarthritis when they see younger adults with chronic back pain, and refer these patients to a rheumatologist if they suspect an inflammatory basis for the pain.

“We also tried to make a simple questionnaire for general practitioners, so they can determine which patient with chronic low back pain should be sent to a rheumatologist to investigate possible spondyloarthritis,” she noted. Possible red flags on the questionnaire include the response to NSAIDs and a family history of spondyloarthritis, Dr. Weel said.

Dr. Weel speaks about spondyloarthritis in a video interview posted at

Source Heidi Spleet/Elsevier Global Medical Newswww.rheumatologynews.com