Photo courtesy of Novartis

The US Food and Drug Administration (FDA) has approved a new formulation of deferasirox known as Jadenu Sprinkle granules.

The granules are approved for use in the same population as Jadenu film-coated tablets.

Both formulations of Jadenu have accelerated approval from the FDA for the treatment of chronic iron overload due to blood transfusions in patients age 2 and older.

The formulations also have accelerated FDA approval for the treatment of chronic iron overload in patients age 10 and older with non-transfusion-dependent-thalassemia and a liver iron concentration of at least 5 mg Fe per gram of dry weight and a serum ferritin greater than 300 mcg/L.

Continued FDA approval for Jadenu in these indications may be contingent upon verification and description of clinical benefit in confirmatory trials.

Jadenu Sprinkle granules are intended for patients who have difficulty swallowing whole tablets. The granules can be sprinkled over soft foods (eg, yogurt or applesauce) prior to consumption.

Like Jadenu film-coated tablets, Jadenu Sprinkle granules are available in 3 strengths—90 mg, 180 mg, and 360 mg.

Both formulations of Jadenu are products of Novartis. For more details on Jadenu, see the prescribing information. 

Photo courtesy of Novartis

The US Food and Drug Administration (FDA) has approved a new formulation of deferasirox known as Jadenu Sprinkle granules.

The granules are approved for use in the same population as Jadenu film-coated tablets.

Both formulations of Jadenu have accelerated approval from the FDA for the treatment of chronic iron overload due to blood transfusions in patients age 2 and older.

The formulations also have accelerated FDA approval for the treatment of chronic iron overload in patients age 10 and older with non-transfusion-dependent-thalassemia and a liver iron concentration of at least 5 mg Fe per gram of dry weight and a serum ferritin greater than 300 mcg/L.

Continued FDA approval for Jadenu in these indications may be contingent upon verification and description of clinical benefit in confirmatory trials.

Jadenu Sprinkle granules are intended for patients who have difficulty swallowing whole tablets. The granules can be sprinkled over soft foods (eg, yogurt or applesauce) prior to consumption.

Like Jadenu film-coated tablets, Jadenu Sprinkle granules are available in 3 strengths—90 mg, 180 mg, and 360 mg.

Both formulations of Jadenu are products of Novartis. For more details on Jadenu, see the prescribing information. 

Photo courtesy of Novartis

The US Food and Drug Administration (FDA) has approved a new formulation of deferasirox known as Jadenu Sprinkle granules.

The granules are approved for use in the same population as Jadenu film-coated tablets.

Both formulations of Jadenu have accelerated approval from the FDA for the treatment of chronic iron overload due to blood transfusions in patients age 2 and older.

The formulations also have accelerated FDA approval for the treatment of chronic iron overload in patients age 10 and older with non-transfusion-dependent-thalassemia and a liver iron concentration of at least 5 mg Fe per gram of dry weight and a serum ferritin greater than 300 mcg/L.

Continued FDA approval for Jadenu in these indications may be contingent upon verification and description of clinical benefit in confirmatory trials.

Jadenu Sprinkle granules are intended for patients who have difficulty swallowing whole tablets. The granules can be sprinkled over soft foods (eg, yogurt or applesauce) prior to consumption.

Like Jadenu film-coated tablets, Jadenu Sprinkle granules are available in 3 strengths—90 mg, 180 mg, and 360 mg.

Both formulations of Jadenu are products of Novartis. For more details on Jadenu, see the prescribing information. 

WASHINGTON – The National Institutes of Health on Monday released its first COPD National Action Plan, a five-point initiative to reduce the burden of chronic obstructive pulmonary disease and increase research into prevention and treatment.

On the same day, the National Heart, Lung, and Blood Institute and other supporters of the plan described its evolution and why they thought the plan’s implementation was important.

• Empower people with COPD, their families, and caregivers to recognize and reduce the burden of COPD.
• Improve the prevention, diagnosis, treatment, and management of COPD by increasing the quality of care delivered across the health care continuum.
• Collect, analyze, report, and disseminate COPD-related public health data that drive change and track progress.
• Increase and sustain research to better understand the prevention, pathogenesis, diagnosis, treatment, and management of COPD.
• Translate national policy, educational, and program recommendations into research and public health care actions.

“Chronic obstructive pulmonary disease is the third-leading cause of death in this country; it’s just behind heart disease and cancer,” Dr. Kiley noted. “What’s really disappointing and discouraging is it’s the only cause of death in this country where the numbers are not declining.”

COPD “got the attention of Congress a number of years ago,” he added. “They encouraged the National Institutes of Health to work with the community stakeholders and other federal agencies to develop a national action plan to respond to the growing burden of this disease.”

COPD’s stakeholder community, the federal government, and other partners worked together to develop a set of core goals that the National Action Plan would address, Dr. Kiley continued. “It was meant to obtain the broadest amount of input possible so that we could get it right from the start.”

Another of the plan’s advocates, MeiLan Han, MD, medical director of the women’s respiratory health program at the University of Michigan, Ann Arbor, illustrated the need to increase and sustain COPD research related to the disease.

[polldaddy:9806142]

“I see the suffering and disease toll that this takes on my patients, and I can’t convince you enough of the level of frustration that I have as a physician in not being able to provide the level of care that I want to be able to provide,” said Dr. Han, who served as a panelist at the press conference.

“We face some serious barriers to being able to provide adequate care for patients,” she added. Those barriers include lack of access to providers who are knowledgeable about COPD, as well as lack of access to affordable and conveniently located pulmonology rehabilitation and education materials. From a research standpoint, Dr. Han added, medicine still doesn’t know enough about the disease. “We certainly have good treatments, but we need better treatments,” she said.

“What’s clear is that we as society can no longer afford to brush this under the table and ignore this problem,” Dr. Han added.

The National Action Plan and information about how to get involved are available at copd.nih.gov.

klennon@frontlinemedcom.com

WASHINGTON – The National Institutes of Health on Monday released its first COPD National Action Plan, a five-point initiative to reduce the burden of chronic obstructive pulmonary disease and increase research into prevention and treatment.

On the same day, the National Heart, Lung, and Blood Institute and other supporters of the plan described its evolution and why they thought the plan’s implementation was important.

• Empower people with COPD, their families, and caregivers to recognize and reduce the burden of COPD.
• Improve the prevention, diagnosis, treatment, and management of COPD by increasing the quality of care delivered across the health care continuum.
• Collect, analyze, report, and disseminate COPD-related public health data that drive change and track progress.
• Increase and sustain research to better understand the prevention, pathogenesis, diagnosis, treatment, and management of COPD.
• Translate national policy, educational, and program recommendations into research and public health care actions.

“Chronic obstructive pulmonary disease is the third-leading cause of death in this country; it’s just behind heart disease and cancer,” Dr. Kiley noted. “What’s really disappointing and discouraging is it’s the only cause of death in this country where the numbers are not declining.”

COPD “got the attention of Congress a number of years ago,” he added. “They encouraged the National Institutes of Health to work with the community stakeholders and other federal agencies to develop a national action plan to respond to the growing burden of this disease.”

COPD’s stakeholder community, the federal government, and other partners worked together to develop a set of core goals that the National Action Plan would address, Dr. Kiley continued. “It was meant to obtain the broadest amount of input possible so that we could get it right from the start.”

Another of the plan’s advocates, MeiLan Han, MD, medical director of the women’s respiratory health program at the University of Michigan, Ann Arbor, illustrated the need to increase and sustain COPD research related to the disease.

[polldaddy:9806142]

“I see the suffering and disease toll that this takes on my patients, and I can’t convince you enough of the level of frustration that I have as a physician in not being able to provide the level of care that I want to be able to provide,” said Dr. Han, who served as a panelist at the press conference.

“We face some serious barriers to being able to provide adequate care for patients,” she added. Those barriers include lack of access to providers who are knowledgeable about COPD, as well as lack of access to affordable and conveniently located pulmonology rehabilitation and education materials. From a research standpoint, Dr. Han added, medicine still doesn’t know enough about the disease. “We certainly have good treatments, but we need better treatments,” she said.

“What’s clear is that we as society can no longer afford to brush this under the table and ignore this problem,” Dr. Han added.

The National Action Plan and information about how to get involved are available at copd.nih.gov.

klennon@frontlinemedcom.com

WASHINGTON – The National Institutes of Health on Monday released its first COPD National Action Plan, a five-point initiative to reduce the burden of chronic obstructive pulmonary disease and increase research into prevention and treatment.

On the same day, the National Heart, Lung, and Blood Institute and other supporters of the plan described its evolution and why they thought the plan’s implementation was important.

• Empower people with COPD, their families, and caregivers to recognize and reduce the burden of COPD.
• Improve the prevention, diagnosis, treatment, and management of COPD by increasing the quality of care delivered across the health care continuum.
• Collect, analyze, report, and disseminate COPD-related public health data that drive change and track progress.
• Increase and sustain research to better understand the prevention, pathogenesis, diagnosis, treatment, and management of COPD.
• Translate national policy, educational, and program recommendations into research and public health care actions.

“Chronic obstructive pulmonary disease is the third-leading cause of death in this country; it’s just behind heart disease and cancer,” Dr. Kiley noted. “What’s really disappointing and discouraging is it’s the only cause of death in this country where the numbers are not declining.”

COPD “got the attention of Congress a number of years ago,” he added. “They encouraged the National Institutes of Health to work with the community stakeholders and other federal agencies to develop a national action plan to respond to the growing burden of this disease.”

COPD’s stakeholder community, the federal government, and other partners worked together to develop a set of core goals that the National Action Plan would address, Dr. Kiley continued. “It was meant to obtain the broadest amount of input possible so that we could get it right from the start.”

Another of the plan’s advocates, MeiLan Han, MD, medical director of the women’s respiratory health program at the University of Michigan, Ann Arbor, illustrated the need to increase and sustain COPD research related to the disease.

[polldaddy:9806142]

“I see the suffering and disease toll that this takes on my patients, and I can’t convince you enough of the level of frustration that I have as a physician in not being able to provide the level of care that I want to be able to provide,” said Dr. Han, who served as a panelist at the press conference.

“We face some serious barriers to being able to provide adequate care for patients,” she added. Those barriers include lack of access to providers who are knowledgeable about COPD, as well as lack of access to affordable and conveniently located pulmonology rehabilitation and education materials. From a research standpoint, Dr. Han added, medicine still doesn’t know enough about the disease. “We certainly have good treatments, but we need better treatments,” she said.

“What’s clear is that we as society can no longer afford to brush this under the table and ignore this problem,” Dr. Han added.

The National Action Plan and information about how to get involved are available at copd.nih.gov.

klennon@frontlinemedcom.com

In an accelerated approval process, the Food and Drug Administration has approved the use of the monoclonal antibody pembrolizumab for treatment of certain solid tumors that have a common biomarker, a first for the agency.

Pembrolizumab (Keytruda) was approved to treat patients whose tumors are metastatic or unresectable, and which have the biomarker microsatellite instability-high (MSI-H), also known as mismatch repair deficient (dMMR). This biomarker is found in many kinds of solid tumors, especially in colorectal and other gastrointestinal cancers, as well as endometrial cancer, and may make tumors more susceptible to host immune system activity. “Approximately 5% of patients with metastatic colorectal cancer have MSI-H or dMMR tumors,” according to the FDA statement announcing the approval.

koakes@frontlinemedcom.com

On Twitter @karioakes

In an accelerated approval process, the Food and Drug Administration has approved the use of the monoclonal antibody pembrolizumab for treatment of certain solid tumors that have a common biomarker, a first for the agency.

Pembrolizumab (Keytruda) was approved to treat patients whose tumors are metastatic or unresectable, and which have the biomarker microsatellite instability-high (MSI-H), also known as mismatch repair deficient (dMMR). This biomarker is found in many kinds of solid tumors, especially in colorectal and other gastrointestinal cancers, as well as endometrial cancer, and may make tumors more susceptible to host immune system activity. “Approximately 5% of patients with metastatic colorectal cancer have MSI-H or dMMR tumors,” according to the FDA statement announcing the approval.

koakes@frontlinemedcom.com

On Twitter @karioakes

In an accelerated approval process, the Food and Drug Administration has approved the use of the monoclonal antibody pembrolizumab for treatment of certain solid tumors that have a common biomarker, a first for the agency.

Pembrolizumab (Keytruda) was approved to treat patients whose tumors are metastatic or unresectable, and which have the biomarker microsatellite instability-high (MSI-H), also known as mismatch repair deficient (dMMR). This biomarker is found in many kinds of solid tumors, especially in colorectal and other gastrointestinal cancers, as well as endometrial cancer, and may make tumors more susceptible to host immune system activity. “Approximately 5% of patients with metastatic colorectal cancer have MSI-H or dMMR tumors,” according to the FDA statement announcing the approval.

koakes@frontlinemedcom.com

On Twitter @karioakes

NEW YORK – A left atrial abnormality on a pretreatment electrocardiogram (ECG) is a moderately specific and sensitive finding that independently predicts risk for developing atrial fibrillation in chronic lymphocytic leukemia patients starting on ibrutinib, findings from a retrospective cohort study indicate.

ECGs are inexpensive and available in most physician’s offices. Routinely checking for a left atrial abnormality before starting ibrutinib would identify a patient subgroup that would benefit from increased monitoring and allow for proactive intervention strategies to reduce complications should atrial fibrillation develop, Anthony Mato, MD, said at the annual meeting of the International Workshop on Chronic Lymphocytic Leukemia.

sworcester@frontlinemedcom.com

NEW YORK – A left atrial abnormality on a pretreatment electrocardiogram (ECG) is a moderately specific and sensitive finding that independently predicts risk for developing atrial fibrillation in chronic lymphocytic leukemia patients starting on ibrutinib, findings from a retrospective cohort study indicate.

ECGs are inexpensive and available in most physician’s offices. Routinely checking for a left atrial abnormality before starting ibrutinib would identify a patient subgroup that would benefit from increased monitoring and allow for proactive intervention strategies to reduce complications should atrial fibrillation develop, Anthony Mato, MD, said at the annual meeting of the International Workshop on Chronic Lymphocytic Leukemia.

sworcester@frontlinemedcom.com

NEW YORK – A left atrial abnormality on a pretreatment electrocardiogram (ECG) is a moderately specific and sensitive finding that independently predicts risk for developing atrial fibrillation in chronic lymphocytic leukemia patients starting on ibrutinib, findings from a retrospective cohort study indicate.

ECGs are inexpensive and available in most physician’s offices. Routinely checking for a left atrial abnormality before starting ibrutinib would identify a patient subgroup that would benefit from increased monitoring and allow for proactive intervention strategies to reduce complications should atrial fibrillation develop, Anthony Mato, MD, said at the annual meeting of the International Workshop on Chronic Lymphocytic Leukemia.

sworcester@frontlinemedcom.com

Dupilumab significantly improved symptoms when used in conjunction with topical steroids over one year in a phase III randomized trial of adults with moderate to severe atopic dermatitis (AD) conducted at 161 centers in 14 countries.

The study is “the first large, randomized, double-blinded placebo-controlled study of long-term systemic treatment in patients with moderate-to-severe atopic dermatitis,” wrote Andrew Blauvelt, MD, president of the Oregon Medical Research Center, Portland, and his coauthors. “These results validate the fundamental role for interleukin 4 and interleukin 13 in the pathogenesis of atopic dermatitis,” they added. The findings were published online (Lancet. 2017 May 4. doi: 10.1016/S0140-6736[17]31191-1).

Dupilumab (Dupixent), a monoclonal antibody that inhibits signaling of both interleukin-4 and interleukin-13, was approved by the Food and Drug Administration in March for treating moderate-to-severe AD in adults.

In the study, known as LIBERTY AD CHRONOS, 740 patients were enrolled and 1-year data were available for 270 adults who received 300 mg of dupilumab once a week plus topical corticosteroids, 89 patients who received 300 mg of dupilumab every two weeks plus topical corticosteroids, and 264 patients who received a placebo plus topical corticosteroids. The two efficacy endpoints were the percent of patients with Investigator’s Global Assessment (IGA) of 0/1 and a 2-point or higher improvement from baseline and a 75% improvement from baseline on the Eczema Area and Severity Index.

At week 16, significantly more patients who received dupilumab plus topical corticosteroids achieved IGA 0/1 (39% of weekly dupilumab plus topical corticosteroids and 39% of those who received dupilumab every 2 weeks plus topical corticosteroids), compared with 12% of placebo/corticosteroid patients. The percentages of patients in each group who met the EASI-75 endpoint were 64%, 69%, and 23%, respectively (P less than .0001).

“The improvement was sustained over the 52-week treatment period,” and the combination therapy was also associated with improvements in “several other measures of clinical signs and symptoms of atopic dermatitis including pruritus, as well as symptoms of anxiety and depression and health-related quality of life, over the 52-week treatment period,” they wrote.

Adverse events were similar among the groups, with 83%, 88%, and 84% of patients in the weekly dupilumab, biweekly dupilumab, and placebo groups, respectively, reporting at least one adverse event. Nonherpetic skin infections were less common among dupilumab patients than among placebo patients, but conjunctivitis was more common among those on dupilumab (14%-19% vs. 8%). “Dupilumab might be the first targeted immune biologic that is neither immunosuppressive nor associated with increased risk of infection but, rather, restorative of barrier and immune function,” the researchers noted.

The results were limited by several factors including the challenges of determining how much topical medication was actually used by patients across multiple study sites, they wrote. However, the data suggest that “the emerging benefit-to-risk profile in this 52-week study supports the role of dupilumab as a primary targeted biologic therapy for up to 1 year in patients with moderate-to-severe atopic dermatitis who are not controlled with topical medications alone,” they said.

The study was funded by Sanofi and Regeneron Pharmaceuticals. Dr. Blauvelt and coauthors disclosed relationships with companies including Sanofi and Regeneron. Several authors were employees of the two companies.

Dupilumab significantly improved symptoms when used in conjunction with topical steroids over one year in a phase III randomized trial of adults with moderate to severe atopic dermatitis (AD) conducted at 161 centers in 14 countries.

The study is “the first large, randomized, double-blinded placebo-controlled study of long-term systemic treatment in patients with moderate-to-severe atopic dermatitis,” wrote Andrew Blauvelt, MD, president of the Oregon Medical Research Center, Portland, and his coauthors. “These results validate the fundamental role for interleukin 4 and interleukin 13 in the pathogenesis of atopic dermatitis,” they added. The findings were published online (Lancet. 2017 May 4. doi: 10.1016/S0140-6736[17]31191-1).

Dupilumab (Dupixent), a monoclonal antibody that inhibits signaling of both interleukin-4 and interleukin-13, was approved by the Food and Drug Administration in March for treating moderate-to-severe AD in adults.

In the study, known as LIBERTY AD CHRONOS, 740 patients were enrolled and 1-year data were available for 270 adults who received 300 mg of dupilumab once a week plus topical corticosteroids, 89 patients who received 300 mg of dupilumab every two weeks plus topical corticosteroids, and 264 patients who received a placebo plus topical corticosteroids. The two efficacy endpoints were the percent of patients with Investigator’s Global Assessment (IGA) of 0/1 and a 2-point or higher improvement from baseline and a 75% improvement from baseline on the Eczema Area and Severity Index.

At week 16, significantly more patients who received dupilumab plus topical corticosteroids achieved IGA 0/1 (39% of weekly dupilumab plus topical corticosteroids and 39% of those who received dupilumab every 2 weeks plus topical corticosteroids), compared with 12% of placebo/corticosteroid patients. The percentages of patients in each group who met the EASI-75 endpoint were 64%, 69%, and 23%, respectively (P less than .0001).

“The improvement was sustained over the 52-week treatment period,” and the combination therapy was also associated with improvements in “several other measures of clinical signs and symptoms of atopic dermatitis including pruritus, as well as symptoms of anxiety and depression and health-related quality of life, over the 52-week treatment period,” they wrote.

Adverse events were similar among the groups, with 83%, 88%, and 84% of patients in the weekly dupilumab, biweekly dupilumab, and placebo groups, respectively, reporting at least one adverse event. Nonherpetic skin infections were less common among dupilumab patients than among placebo patients, but conjunctivitis was more common among those on dupilumab (14%-19% vs. 8%). “Dupilumab might be the first targeted immune biologic that is neither immunosuppressive nor associated with increased risk of infection but, rather, restorative of barrier and immune function,” the researchers noted.

The results were limited by several factors including the challenges of determining how much topical medication was actually used by patients across multiple study sites, they wrote. However, the data suggest that “the emerging benefit-to-risk profile in this 52-week study supports the role of dupilumab as a primary targeted biologic therapy for up to 1 year in patients with moderate-to-severe atopic dermatitis who are not controlled with topical medications alone,” they said.

The study was funded by Sanofi and Regeneron Pharmaceuticals. Dr. Blauvelt and coauthors disclosed relationships with companies including Sanofi and Regeneron. Several authors were employees of the two companies.

Dupilumab significantly improved symptoms when used in conjunction with topical steroids over one year in a phase III randomized trial of adults with moderate to severe atopic dermatitis (AD) conducted at 161 centers in 14 countries.

The study is “the first large, randomized, double-blinded placebo-controlled study of long-term systemic treatment in patients with moderate-to-severe atopic dermatitis,” wrote Andrew Blauvelt, MD, president of the Oregon Medical Research Center, Portland, and his coauthors. “These results validate the fundamental role for interleukin 4 and interleukin 13 in the pathogenesis of atopic dermatitis,” they added. The findings were published online (Lancet. 2017 May 4. doi: 10.1016/S0140-6736[17]31191-1).

Dupilumab (Dupixent), a monoclonal antibody that inhibits signaling of both interleukin-4 and interleukin-13, was approved by the Food and Drug Administration in March for treating moderate-to-severe AD in adults.

In the study, known as LIBERTY AD CHRONOS, 740 patients were enrolled and 1-year data were available for 270 adults who received 300 mg of dupilumab once a week plus topical corticosteroids, 89 patients who received 300 mg of dupilumab every two weeks plus topical corticosteroids, and 264 patients who received a placebo plus topical corticosteroids. The two efficacy endpoints were the percent of patients with Investigator’s Global Assessment (IGA) of 0/1 and a 2-point or higher improvement from baseline and a 75% improvement from baseline on the Eczema Area and Severity Index.

At week 16, significantly more patients who received dupilumab plus topical corticosteroids achieved IGA 0/1 (39% of weekly dupilumab plus topical corticosteroids and 39% of those who received dupilumab every 2 weeks plus topical corticosteroids), compared with 12% of placebo/corticosteroid patients. The percentages of patients in each group who met the EASI-75 endpoint were 64%, 69%, and 23%, respectively (P less than .0001).

“The improvement was sustained over the 52-week treatment period,” and the combination therapy was also associated with improvements in “several other measures of clinical signs and symptoms of atopic dermatitis including pruritus, as well as symptoms of anxiety and depression and health-related quality of life, over the 52-week treatment period,” they wrote.

Adverse events were similar among the groups, with 83%, 88%, and 84% of patients in the weekly dupilumab, biweekly dupilumab, and placebo groups, respectively, reporting at least one adverse event. Nonherpetic skin infections were less common among dupilumab patients than among placebo patients, but conjunctivitis was more common among those on dupilumab (14%-19% vs. 8%). “Dupilumab might be the first targeted immune biologic that is neither immunosuppressive nor associated with increased risk of infection but, rather, restorative of barrier and immune function,” the researchers noted.

The results were limited by several factors including the challenges of determining how much topical medication was actually used by patients across multiple study sites, they wrote. However, the data suggest that “the emerging benefit-to-risk profile in this 52-week study supports the role of dupilumab as a primary targeted biologic therapy for up to 1 year in patients with moderate-to-severe atopic dermatitis who are not controlled with topical medications alone,” they said.

The study was funded by Sanofi and Regeneron Pharmaceuticals. Dr. Blauvelt and coauthors disclosed relationships with companies including Sanofi and Regeneron. Several authors were employees of the two companies.

CHICAGO – The biosimilar infliximab CT-P13 is not inferior to the originator infliximab in terms of efficacy, safety, and immunogenicity in the treatment of inflammatory bowel disease (IBD), a phase IV randomized trial showed.

Patient outcomes were not compromised with the use of the biosimilar, and the cost of treatment was much lower, said lead author Kristin K. Jørgensen, MD, PhD, at Digestive Disease Week^®.

“Biologics represent a substantial source of IBD expenditure,” said Dr. Jørgensen of Akershus University Hospital, Lørenskog, Norway. “The medication is expensive, patients are treated on a long-term basis, and the incidence of IBD is increasing.”

Biosimilars are biotherapeutic products that are similar in terms of quality, safety, and efficacy to the already licensed reference biologic product. “Use of biosimilars can potentially dramatically decrease costs and may lead to better patient care,” said Dr. Jørgensen. “The patient gets increased access to biologic therapy, and it is easier to intensify dosing if indicated.”

Tumor necrosis factor–inhibitors are commonly used to treat Crohn’s disease, ulcerative colitis, spondyloarthritis, rheumatoid arthritis, psoriatic arthritis, and chronic plaque psoriasis, and, while they have altered the treatment paradigm, they are expensive products.

The goal of the NOR-SWITCH was to evaluate switching from originator infliximab to CT-P13, in terms of efficacy, safety, and immunogenicity.

Dr. Jørgensen and her colleagues conducted a randomized phase IV trial that enrolled 482 patients who were randomly assigned to either infliximab originator (n = 241) or CT-P13 (n = 241). The primary endpoint was disease worsening during follow-up.

Of the group, 155 patients (32%) had Crohn’s disease, 93 (19%) had ulcerative colitis, 91 (19%) had spondyloarthritis, 77 (16%) had rheumatoid arthritis, 30 (6%) had psoriatic arthritis, and 35 (7%) had chronic plaque psoriasis.

Disease worsening occurred at a similar rate in both groups. In the infliximab originator group, 53 patients (26%) experienced a worsening of their symptoms, compared with 61 patients (30%) in the CT-P13 group. The 95% confidence interval of the adjusted risk difference (−4.4%) was −12.7% to 3.9%, which fell within the prespecified noninferiority margin of 15%.

Therefore, the findings demonstrated that CT-P13 is not inferior to infliximab originator, and the adjusted relative risk of disease worsening for CT-P13 patients was 1.17 (95% CI, 0.82-1.52), compared with the infliximab originator group.

An almost equal number of patients achieved disease remission, 123 patients (61%) in the infliximab originator group and 126 patients (61%) in the CT-P13 group, and the adjusted rate difference was 0.6% (95% CI, –7.5%-8.8%; per-protocol set).

An explorative subgroup analysis that looked at patients with Crohn’s disease and ulcerative colitis showed similar findings between patients treated with either agent.

“Our results support switching from the originator to a biosimilar for nonmedical reasons,” concluded Dr. Jørgensen.

However, she urged caution in generalizing these findings to other biologic agents.

The study was funded by the Norwegian Ministry of Health and Care Services. Dr. Jorgensen reported receiving personal fees from Tillotts, Intercept, and Celltrion. Several coauthors also reported relationships with industry.

Digestive Disease Week^® is jointly sponsored by the American Association for the Study of Liver Diseases (AASLD), the American Gastroenterological Association (AGA) Institute, the American Society for Gastrointestinal Endoscopy (ASGE), and the Society for Surgery of the Alimentary Tract (SSAT).

CHICAGO – The biosimilar infliximab CT-P13 is not inferior to the originator infliximab in terms of efficacy, safety, and immunogenicity in the treatment of inflammatory bowel disease (IBD), a phase IV randomized trial showed.

Patient outcomes were not compromised with the use of the biosimilar, and the cost of treatment was much lower, said lead author Kristin K. Jørgensen, MD, PhD, at Digestive Disease Week^®.

“Biologics represent a substantial source of IBD expenditure,” said Dr. Jørgensen of Akershus University Hospital, Lørenskog, Norway. “The medication is expensive, patients are treated on a long-term basis, and the incidence of IBD is increasing.”

Biosimilars are biotherapeutic products that are similar in terms of quality, safety, and efficacy to the already licensed reference biologic product. “Use of biosimilars can potentially dramatically decrease costs and may lead to better patient care,” said Dr. Jørgensen. “The patient gets increased access to biologic therapy, and it is easier to intensify dosing if indicated.”

Tumor necrosis factor–inhibitors are commonly used to treat Crohn’s disease, ulcerative colitis, spondyloarthritis, rheumatoid arthritis, psoriatic arthritis, and chronic plaque psoriasis, and, while they have altered the treatment paradigm, they are expensive products.

The goal of the NOR-SWITCH was to evaluate switching from originator infliximab to CT-P13, in terms of efficacy, safety, and immunogenicity.

Dr. Jørgensen and her colleagues conducted a randomized phase IV trial that enrolled 482 patients who were randomly assigned to either infliximab originator (n = 241) or CT-P13 (n = 241). The primary endpoint was disease worsening during follow-up.

Of the group, 155 patients (32%) had Crohn’s disease, 93 (19%) had ulcerative colitis, 91 (19%) had spondyloarthritis, 77 (16%) had rheumatoid arthritis, 30 (6%) had psoriatic arthritis, and 35 (7%) had chronic plaque psoriasis.

Disease worsening occurred at a similar rate in both groups. In the infliximab originator group, 53 patients (26%) experienced a worsening of their symptoms, compared with 61 patients (30%) in the CT-P13 group. The 95% confidence interval of the adjusted risk difference (−4.4%) was −12.7% to 3.9%, which fell within the prespecified noninferiority margin of 15%.

Therefore, the findings demonstrated that CT-P13 is not inferior to infliximab originator, and the adjusted relative risk of disease worsening for CT-P13 patients was 1.17 (95% CI, 0.82-1.52), compared with the infliximab originator group.

An almost equal number of patients achieved disease remission, 123 patients (61%) in the infliximab originator group and 126 patients (61%) in the CT-P13 group, and the adjusted rate difference was 0.6% (95% CI, –7.5%-8.8%; per-protocol set).

An explorative subgroup analysis that looked at patients with Crohn’s disease and ulcerative colitis showed similar findings between patients treated with either agent.

“Our results support switching from the originator to a biosimilar for nonmedical reasons,” concluded Dr. Jørgensen.

However, she urged caution in generalizing these findings to other biologic agents.

The study was funded by the Norwegian Ministry of Health and Care Services. Dr. Jorgensen reported receiving personal fees from Tillotts, Intercept, and Celltrion. Several coauthors also reported relationships with industry.

Digestive Disease Week^® is jointly sponsored by the American Association for the Study of Liver Diseases (AASLD), the American Gastroenterological Association (AGA) Institute, the American Society for Gastrointestinal Endoscopy (ASGE), and the Society for Surgery of the Alimentary Tract (SSAT).

CHICAGO – The biosimilar infliximab CT-P13 is not inferior to the originator infliximab in terms of efficacy, safety, and immunogenicity in the treatment of inflammatory bowel disease (IBD), a phase IV randomized trial showed.

Patient outcomes were not compromised with the use of the biosimilar, and the cost of treatment was much lower, said lead author Kristin K. Jørgensen, MD, PhD, at Digestive Disease Week^®.

“Biologics represent a substantial source of IBD expenditure,” said Dr. Jørgensen of Akershus University Hospital, Lørenskog, Norway. “The medication is expensive, patients are treated on a long-term basis, and the incidence of IBD is increasing.”

Biosimilars are biotherapeutic products that are similar in terms of quality, safety, and efficacy to the already licensed reference biologic product. “Use of biosimilars can potentially dramatically decrease costs and may lead to better patient care,” said Dr. Jørgensen. “The patient gets increased access to biologic therapy, and it is easier to intensify dosing if indicated.”

Tumor necrosis factor–inhibitors are commonly used to treat Crohn’s disease, ulcerative colitis, spondyloarthritis, rheumatoid arthritis, psoriatic arthritis, and chronic plaque psoriasis, and, while they have altered the treatment paradigm, they are expensive products.

The goal of the NOR-SWITCH was to evaluate switching from originator infliximab to CT-P13, in terms of efficacy, safety, and immunogenicity.

Dr. Jørgensen and her colleagues conducted a randomized phase IV trial that enrolled 482 patients who were randomly assigned to either infliximab originator (n = 241) or CT-P13 (n = 241). The primary endpoint was disease worsening during follow-up.

Of the group, 155 patients (32%) had Crohn’s disease, 93 (19%) had ulcerative colitis, 91 (19%) had spondyloarthritis, 77 (16%) had rheumatoid arthritis, 30 (6%) had psoriatic arthritis, and 35 (7%) had chronic plaque psoriasis.

Disease worsening occurred at a similar rate in both groups. In the infliximab originator group, 53 patients (26%) experienced a worsening of their symptoms, compared with 61 patients (30%) in the CT-P13 group. The 95% confidence interval of the adjusted risk difference (−4.4%) was −12.7% to 3.9%, which fell within the prespecified noninferiority margin of 15%.

Therefore, the findings demonstrated that CT-P13 is not inferior to infliximab originator, and the adjusted relative risk of disease worsening for CT-P13 patients was 1.17 (95% CI, 0.82-1.52), compared with the infliximab originator group.

An almost equal number of patients achieved disease remission, 123 patients (61%) in the infliximab originator group and 126 patients (61%) in the CT-P13 group, and the adjusted rate difference was 0.6% (95% CI, –7.5%-8.8%; per-protocol set).

An explorative subgroup analysis that looked at patients with Crohn’s disease and ulcerative colitis showed similar findings between patients treated with either agent.

“Our results support switching from the originator to a biosimilar for nonmedical reasons,” concluded Dr. Jørgensen.

However, she urged caution in generalizing these findings to other biologic agents.

The study was funded by the Norwegian Ministry of Health and Care Services. Dr. Jorgensen reported receiving personal fees from Tillotts, Intercept, and Celltrion. Several coauthors also reported relationships with industry.

Digestive Disease Week^® is jointly sponsored by the American Association for the Study of Liver Diseases (AASLD), the American Gastroenterological Association (AGA) Institute, the American Society for Gastrointestinal Endoscopy (ASGE), and the Society for Surgery of the Alimentary Tract (SSAT).

SAN DIEGO – Is it okay for pregnant women to attend CrossFit classes? Are patients who run for fun at increased risk for osteoarthritis? Does stretching before exercise provide any benefits to athletes?

Experts discussed these topics during a session titled “Mythbusters in sports medicine” at the annual meeting of the American Medical Society for Sports Medicine.
 

Does exercise negatively impact pregnancy?

The idea that strenuous exercise during pregnancy can harm a baby’s health is a myth, according to Elizabeth A. Joy, MD.

“Women having healthy, uncomplicated pregnancies should be encouraged to be physically active throughout pregnancy, with a goal of achieving 150 minutes per week of moderate-intensity activity,” she said. “Fit pregnant women who were habitually performing high-intensity exercise before pregnancy can continue to do so during pregnancy, assuming an otherwise healthy, uncomplicated pregnancy.”

Results from more than 600 studies in the medical literature indicate that exercise during pregnancy is safe for moms and babies, noted Dr. Joy, medical director for community health and food and nutrition at Intermountain Healthcare in Salt Lake City, Utah.

In fact, the 2008 Physical Activity Guidelines for Americans state that pregnant women who habitually engage in vigorous-intensity aerobic activity or who are highly active “can continue physical activity during pregnancy and the postpartum period, provided that they remain healthy and discuss with their health care provider how and when activity should be adjusted over time.”

Such advice wasn’t always supported by the medical profession. In fact, 1985 guidelines from the American College of Obstetricians and Gynecologists recommended that women limit exercise to no more than 15 minutes at a time during pregnancy and keep their maternal heart rate less than 140 beats per minute. ACOG also discouraged previously sedentary women from beginning an exercise program during pregnancy.

“Sadly, women are still getting this advice,” said Dr. Joy, who is also president of the American College of Sports Medicine. According to the 2005-2010 National Ambulatory Medical Care Survey, only 18% of pregnant women reported receiving counseling to be physically active during their pregnancies (Matern Child Health J. 2014 Sep;18[7]:1610-18). “That is just unacceptable,” she said.

In a prospective study of the association between vigorous physical activity during pregnancy and length of gestation and birth weight, researchers evaluated 1,647 births among primiparous women (Matern Child Health J. 2012 Jul;16[5]:1031-44).

Does running cause knee OA?

During another talk at the meeting, William O. Roberts, MD, characterized the notion that running causes knee osteoarthritis as largely a myth for recreational runners. However, elite runners and athletes who participate in other sports may face an increased risk of developing the condition.

Well-established risk factors for knee OA include post–joint injury proteases and cytokines and injury load stress on articular cartilage. “Other risk factors include overweight and obesity, a family history of OA, exercise, heavy work that involved squatting and kneeling, and being female,” said Dr. Roberts, professor of family medicine and community health at the University of Minnesota, Minneapolis.

He discussed three articles on the topic drawn from medical literature. One was a retrospective cross-sectional analysis of 2,637 Osteoarthritis Initiative participants, 45-79 years of age, who had knee-specific pain or knee x-ray data 4 years into the 10-year–long study (Arthritis Care Res. 2017 Feb;69[2]:183-91).

More than half of the participants (56%) were female, their mean body mass index was 28.5 kg/m², only 20% reported more than 2,000 bouts of running during their lifetime, and about 5% had run competitively.

Adjusted odds ratios of pain, radiographic OA, and symptomatic OA for those prior runners and current runners, compared with those who never ran, were 0.82 and 0.76 (P for trend = .02), 0.98 and 0.91 (P for trend = .05), and 0.88 and 0.71 (P for trend = .03), respectively.

Does it help to stretch before exercise?

Stretching before engaging in exercise is a common practice often recommended by coaches and clinicians – but it appears to have no role in preventing injuries during exercise itself.

Several decades ago, investigators subscribed to muscle spasm theory, which held that unaccustomed exercise caused muscle spasms.

“The thought was that muscle spasms impeded blood flow to the muscle, causing ischemic pain and further spasm,” Valerie E. Cothran, MD, said during a presentation at the meeting. “Stretching the muscle was thought to restore blood flow to the muscle and interrupt the pain-spasm-pain cycle. This theory has been discredited for 40 years, but the practice of stretching before exercise persists.”

According to Dr. Cothran, of the department of family and community medicine at the University of Maryland, Baltimore, a limited number of randomized, controlled trials exist on the topic – and many are fraught with limitations, such as the evaluation of multiple stretching methods and variable types of sports activities and the inclusion of multiple cointerventions.

One systematic review evaluated 361 randomized, controlled trials and cohort studies of interventions that included stretching and that appeared in the medical literature from 1966 to 2002 (Med Sci Sports Exerc. 2004 Mar;36[3]:371-8). Studies with no controls were excluded from the analysis, as were those in which stretching could not be assessed independently or those that did not include people engaged in sports or fitness activities.

The researchers determined that stretching was not significantly associated with a reduction in total injuries (OR, 0.93). “There is not sufficient evidence to endorse or discontinue routine stretching before or after exercise to prevent injury among competitive or recreational athletes,” they concluded.

dbrunk@frontlinemedcom.com

SAN DIEGO – Is it okay for pregnant women to attend CrossFit classes? Are patients who run for fun at increased risk for osteoarthritis? Does stretching before exercise provide any benefits to athletes?

Experts discussed these topics during a session titled “Mythbusters in sports medicine” at the annual meeting of the American Medical Society for Sports Medicine.
 

Does exercise negatively impact pregnancy?

The idea that strenuous exercise during pregnancy can harm a baby’s health is a myth, according to Elizabeth A. Joy, MD.

“Women having healthy, uncomplicated pregnancies should be encouraged to be physically active throughout pregnancy, with a goal of achieving 150 minutes per week of moderate-intensity activity,” she said. “Fit pregnant women who were habitually performing high-intensity exercise before pregnancy can continue to do so during pregnancy, assuming an otherwise healthy, uncomplicated pregnancy.”

Results from more than 600 studies in the medical literature indicate that exercise during pregnancy is safe for moms and babies, noted Dr. Joy, medical director for community health and food and nutrition at Intermountain Healthcare in Salt Lake City, Utah.

In fact, the 2008 Physical Activity Guidelines for Americans state that pregnant women who habitually engage in vigorous-intensity aerobic activity or who are highly active “can continue physical activity during pregnancy and the postpartum period, provided that they remain healthy and discuss with their health care provider how and when activity should be adjusted over time.”

Such advice wasn’t always supported by the medical profession. In fact, 1985 guidelines from the American College of Obstetricians and Gynecologists recommended that women limit exercise to no more than 15 minutes at a time during pregnancy and keep their maternal heart rate less than 140 beats per minute. ACOG also discouraged previously sedentary women from beginning an exercise program during pregnancy.

“Sadly, women are still getting this advice,” said Dr. Joy, who is also president of the American College of Sports Medicine. According to the 2005-2010 National Ambulatory Medical Care Survey, only 18% of pregnant women reported receiving counseling to be physically active during their pregnancies (Matern Child Health J. 2014 Sep;18[7]:1610-18). “That is just unacceptable,” she said.

In a prospective study of the association between vigorous physical activity during pregnancy and length of gestation and birth weight, researchers evaluated 1,647 births among primiparous women (Matern Child Health J. 2012 Jul;16[5]:1031-44).

Does running cause knee OA?

During another talk at the meeting, William O. Roberts, MD, characterized the notion that running causes knee osteoarthritis as largely a myth for recreational runners. However, elite runners and athletes who participate in other sports may face an increased risk of developing the condition.

Well-established risk factors for knee OA include post–joint injury proteases and cytokines and injury load stress on articular cartilage. “Other risk factors include overweight and obesity, a family history of OA, exercise, heavy work that involved squatting and kneeling, and being female,” said Dr. Roberts, professor of family medicine and community health at the University of Minnesota, Minneapolis.

He discussed three articles on the topic drawn from medical literature. One was a retrospective cross-sectional analysis of 2,637 Osteoarthritis Initiative participants, 45-79 years of age, who had knee-specific pain or knee x-ray data 4 years into the 10-year–long study (Arthritis Care Res. 2017 Feb;69[2]:183-91).

More than half of the participants (56%) were female, their mean body mass index was 28.5 kg/m², only 20% reported more than 2,000 bouts of running during their lifetime, and about 5% had run competitively.

Adjusted odds ratios of pain, radiographic OA, and symptomatic OA for those prior runners and current runners, compared with those who never ran, were 0.82 and 0.76 (P for trend = .02), 0.98 and 0.91 (P for trend = .05), and 0.88 and 0.71 (P for trend = .03), respectively.

Does it help to stretch before exercise?

Stretching before engaging in exercise is a common practice often recommended by coaches and clinicians – but it appears to have no role in preventing injuries during exercise itself.

Several decades ago, investigators subscribed to muscle spasm theory, which held that unaccustomed exercise caused muscle spasms.

“The thought was that muscle spasms impeded blood flow to the muscle, causing ischemic pain and further spasm,” Valerie E. Cothran, MD, said during a presentation at the meeting. “Stretching the muscle was thought to restore blood flow to the muscle and interrupt the pain-spasm-pain cycle. This theory has been discredited for 40 years, but the practice of stretching before exercise persists.”

According to Dr. Cothran, of the department of family and community medicine at the University of Maryland, Baltimore, a limited number of randomized, controlled trials exist on the topic – and many are fraught with limitations, such as the evaluation of multiple stretching methods and variable types of sports activities and the inclusion of multiple cointerventions.

One systematic review evaluated 361 randomized, controlled trials and cohort studies of interventions that included stretching and that appeared in the medical literature from 1966 to 2002 (Med Sci Sports Exerc. 2004 Mar;36[3]:371-8). Studies with no controls were excluded from the analysis, as were those in which stretching could not be assessed independently or those that did not include people engaged in sports or fitness activities.

The researchers determined that stretching was not significantly associated with a reduction in total injuries (OR, 0.93). “There is not sufficient evidence to endorse or discontinue routine stretching before or after exercise to prevent injury among competitive or recreational athletes,” they concluded.

dbrunk@frontlinemedcom.com

SAN DIEGO – Is it okay for pregnant women to attend CrossFit classes? Are patients who run for fun at increased risk for osteoarthritis? Does stretching before exercise provide any benefits to athletes?

Experts discussed these topics during a session titled “Mythbusters in sports medicine” at the annual meeting of the American Medical Society for Sports Medicine.
 

Does exercise negatively impact pregnancy?

The idea that strenuous exercise during pregnancy can harm a baby’s health is a myth, according to Elizabeth A. Joy, MD.

“Women having healthy, uncomplicated pregnancies should be encouraged to be physically active throughout pregnancy, with a goal of achieving 150 minutes per week of moderate-intensity activity,” she said. “Fit pregnant women who were habitually performing high-intensity exercise before pregnancy can continue to do so during pregnancy, assuming an otherwise healthy, uncomplicated pregnancy.”

Results from more than 600 studies in the medical literature indicate that exercise during pregnancy is safe for moms and babies, noted Dr. Joy, medical director for community health and food and nutrition at Intermountain Healthcare in Salt Lake City, Utah.

In fact, the 2008 Physical Activity Guidelines for Americans state that pregnant women who habitually engage in vigorous-intensity aerobic activity or who are highly active “can continue physical activity during pregnancy and the postpartum period, provided that they remain healthy and discuss with their health care provider how and when activity should be adjusted over time.”

Such advice wasn’t always supported by the medical profession. In fact, 1985 guidelines from the American College of Obstetricians and Gynecologists recommended that women limit exercise to no more than 15 minutes at a time during pregnancy and keep their maternal heart rate less than 140 beats per minute. ACOG also discouraged previously sedentary women from beginning an exercise program during pregnancy.

“Sadly, women are still getting this advice,” said Dr. Joy, who is also president of the American College of Sports Medicine. According to the 2005-2010 National Ambulatory Medical Care Survey, only 18% of pregnant women reported receiving counseling to be physically active during their pregnancies (Matern Child Health J. 2014 Sep;18[7]:1610-18). “That is just unacceptable,” she said.

In a prospective study of the association between vigorous physical activity during pregnancy and length of gestation and birth weight, researchers evaluated 1,647 births among primiparous women (Matern Child Health J. 2012 Jul;16[5]:1031-44).

Does running cause knee OA?

During another talk at the meeting, William O. Roberts, MD, characterized the notion that running causes knee osteoarthritis as largely a myth for recreational runners. However, elite runners and athletes who participate in other sports may face an increased risk of developing the condition.

Well-established risk factors for knee OA include post–joint injury proteases and cytokines and injury load stress on articular cartilage. “Other risk factors include overweight and obesity, a family history of OA, exercise, heavy work that involved squatting and kneeling, and being female,” said Dr. Roberts, professor of family medicine and community health at the University of Minnesota, Minneapolis.

He discussed three articles on the topic drawn from medical literature. One was a retrospective cross-sectional analysis of 2,637 Osteoarthritis Initiative participants, 45-79 years of age, who had knee-specific pain or knee x-ray data 4 years into the 10-year–long study (Arthritis Care Res. 2017 Feb;69[2]:183-91).

More than half of the participants (56%) were female, their mean body mass index was 28.5 kg/m², only 20% reported more than 2,000 bouts of running during their lifetime, and about 5% had run competitively.

Adjusted odds ratios of pain, radiographic OA, and symptomatic OA for those prior runners and current runners, compared with those who never ran, were 0.82 and 0.76 (P for trend = .02), 0.98 and 0.91 (P for trend = .05), and 0.88 and 0.71 (P for trend = .03), respectively.

Does it help to stretch before exercise?

Stretching before engaging in exercise is a common practice often recommended by coaches and clinicians – but it appears to have no role in preventing injuries during exercise itself.

Several decades ago, investigators subscribed to muscle spasm theory, which held that unaccustomed exercise caused muscle spasms.

“The thought was that muscle spasms impeded blood flow to the muscle, causing ischemic pain and further spasm,” Valerie E. Cothran, MD, said during a presentation at the meeting. “Stretching the muscle was thought to restore blood flow to the muscle and interrupt the pain-spasm-pain cycle. This theory has been discredited for 40 years, but the practice of stretching before exercise persists.”

According to Dr. Cothran, of the department of family and community medicine at the University of Maryland, Baltimore, a limited number of randomized, controlled trials exist on the topic – and many are fraught with limitations, such as the evaluation of multiple stretching methods and variable types of sports activities and the inclusion of multiple cointerventions.

One systematic review evaluated 361 randomized, controlled trials and cohort studies of interventions that included stretching and that appeared in the medical literature from 1966 to 2002 (Med Sci Sports Exerc. 2004 Mar;36[3]:371-8). Studies with no controls were excluded from the analysis, as were those in which stretching could not be assessed independently or those that did not include people engaged in sports or fitness activities.

The researchers determined that stretching was not significantly associated with a reduction in total injuries (OR, 0.93). “There is not sufficient evidence to endorse or discontinue routine stretching before or after exercise to prevent injury among competitive or recreational athletes,” they concluded.

dbrunk@frontlinemedcom.com

CHICAGO – Acute kidney injury (AKI) doubles the risk of death among patients hospitalized for acute pancreatitis, Kalpit Devani, MD, reported at the annual Digestive Disease Week^®.

This severe complication of acute pancreatitis also significantly increases the length of stay and drives up hospital costs, said Dr. Devani of East Tennessee State University, Johnson City. Fortunately, although the risks associated with it remain high, death from AKI in the setting of acute pancreatitis has decreased significantly, from a high of 17% in 2002 to 6.4% in 2012, Dr. Devani determined in his database review.

“Increasing awareness and prompt diagnosis of AKI could be the reason for the increasing trend of prevalence of AKI in acute pancreatitis patients,” he said in an interview. “Decreasing mortality can be related to adherence to recent advances in the management approach of acute pancreatitis, such as early (within 24 hours) and aggressive intravenous hydration and early enteral feeding.”

Dr. Devani examined these trends in data extracted from the National Inpatient Sample, 2002-2012. During that 10-year period, almost 3.5 million adults were hospitalized for acute pancreatitis. These patients were a mean of 53 years old, and half were women. Their mean length of stay was just over 5 days, at a mean cost of about $12,000. Of these, 273,687 (7.9%) also developed AKI.

There were some significant differences between those who did and did not develop AKI. AKI patients were significantly older (61 vs. 53 years), and less likely to be women (43% vs. 51%). They had a higher Charlson Comorbidity Index score (1.49 vs. 0.84). They were also significantly more likely to develop a number of complications, including systemic inflammatory response syndrome (2% vs. 0.4%), septic shock (6% vs. 0.3%), sepsis (8.7% vs. 1.4%), acute respiratory failure (18% vs. 2%), and electrolyte disorder (72% vs. 30%).

Not surprisingly, their length of stay was significantly longer (10 vs. 5 days), as was hospitalization cost ($25,923 vs. $10,889). Mortality was much higher, at almost 9% vs. 0.7%.

In a propensity matching analysis, Dr. Devani matched 53,000 pairs of acute pancreatitis patients with and without AKI. This determined that those with AKI faced a doubling in the risk of in-hospital mortality.

He also examined temporal trends with regard to the complication. The rate of diagnosed AKI in hospitalized acute pancreatitis cases rose dramatically, from 4% in 2002 to 11.6% in 2012. However, mortality in acute pancreatitis patients decreased among both those with AKI (17%-6%) and those without (1%-0.4%).

The mean length of stay in patients with AKI and pancreatitis likewise fell, from 14.8 to 8.6 days. Not surprisingly, total hospitalization cost for these patients fell as well ($42,975-$20,716).

Among pancreatitis patients without AKI, length of stay and costs declined, although not as dramatically as they did among AKI patients (6-5 days; $13,654-$10,895).

Dr. Devani had no financial disclosures.

msullivan@frontlinemedcom.com

On Twitter @alz_gal

CHICAGO – Acute kidney injury (AKI) doubles the risk of death among patients hospitalized for acute pancreatitis, Kalpit Devani, MD, reported at the annual Digestive Disease Week^®.

This severe complication of acute pancreatitis also significantly increases the length of stay and drives up hospital costs, said Dr. Devani of East Tennessee State University, Johnson City. Fortunately, although the risks associated with it remain high, death from AKI in the setting of acute pancreatitis has decreased significantly, from a high of 17% in 2002 to 6.4% in 2012, Dr. Devani determined in his database review.

“Increasing awareness and prompt diagnosis of AKI could be the reason for the increasing trend of prevalence of AKI in acute pancreatitis patients,” he said in an interview. “Decreasing mortality can be related to adherence to recent advances in the management approach of acute pancreatitis, such as early (within 24 hours) and aggressive intravenous hydration and early enteral feeding.”

Dr. Devani examined these trends in data extracted from the National Inpatient Sample, 2002-2012. During that 10-year period, almost 3.5 million adults were hospitalized for acute pancreatitis. These patients were a mean of 53 years old, and half were women. Their mean length of stay was just over 5 days, at a mean cost of about $12,000. Of these, 273,687 (7.9%) also developed AKI.

There were some significant differences between those who did and did not develop AKI. AKI patients were significantly older (61 vs. 53 years), and less likely to be women (43% vs. 51%). They had a higher Charlson Comorbidity Index score (1.49 vs. 0.84). They were also significantly more likely to develop a number of complications, including systemic inflammatory response syndrome (2% vs. 0.4%), septic shock (6% vs. 0.3%), sepsis (8.7% vs. 1.4%), acute respiratory failure (18% vs. 2%), and electrolyte disorder (72% vs. 30%).

Not surprisingly, their length of stay was significantly longer (10 vs. 5 days), as was hospitalization cost ($25,923 vs. $10,889). Mortality was much higher, at almost 9% vs. 0.7%.

In a propensity matching analysis, Dr. Devani matched 53,000 pairs of acute pancreatitis patients with and without AKI. This determined that those with AKI faced a doubling in the risk of in-hospital mortality.

He also examined temporal trends with regard to the complication. The rate of diagnosed AKI in hospitalized acute pancreatitis cases rose dramatically, from 4% in 2002 to 11.6% in 2012. However, mortality in acute pancreatitis patients decreased among both those with AKI (17%-6%) and those without (1%-0.4%).

The mean length of stay in patients with AKI and pancreatitis likewise fell, from 14.8 to 8.6 days. Not surprisingly, total hospitalization cost for these patients fell as well ($42,975-$20,716).

Among pancreatitis patients without AKI, length of stay and costs declined, although not as dramatically as they did among AKI patients (6-5 days; $13,654-$10,895).

Dr. Devani had no financial disclosures.

msullivan@frontlinemedcom.com

On Twitter @alz_gal

CHICAGO – Acute kidney injury (AKI) doubles the risk of death among patients hospitalized for acute pancreatitis, Kalpit Devani, MD, reported at the annual Digestive Disease Week^®.

This severe complication of acute pancreatitis also significantly increases the length of stay and drives up hospital costs, said Dr. Devani of East Tennessee State University, Johnson City. Fortunately, although the risks associated with it remain high, death from AKI in the setting of acute pancreatitis has decreased significantly, from a high of 17% in 2002 to 6.4% in 2012, Dr. Devani determined in his database review.

“Increasing awareness and prompt diagnosis of AKI could be the reason for the increasing trend of prevalence of AKI in acute pancreatitis patients,” he said in an interview. “Decreasing mortality can be related to adherence to recent advances in the management approach of acute pancreatitis, such as early (within 24 hours) and aggressive intravenous hydration and early enteral feeding.”

Dr. Devani examined these trends in data extracted from the National Inpatient Sample, 2002-2012. During that 10-year period, almost 3.5 million adults were hospitalized for acute pancreatitis. These patients were a mean of 53 years old, and half were women. Their mean length of stay was just over 5 days, at a mean cost of about $12,000. Of these, 273,687 (7.9%) also developed AKI.

There were some significant differences between those who did and did not develop AKI. AKI patients were significantly older (61 vs. 53 years), and less likely to be women (43% vs. 51%). They had a higher Charlson Comorbidity Index score (1.49 vs. 0.84). They were also significantly more likely to develop a number of complications, including systemic inflammatory response syndrome (2% vs. 0.4%), septic shock (6% vs. 0.3%), sepsis (8.7% vs. 1.4%), acute respiratory failure (18% vs. 2%), and electrolyte disorder (72% vs. 30%).

Not surprisingly, their length of stay was significantly longer (10 vs. 5 days), as was hospitalization cost ($25,923 vs. $10,889). Mortality was much higher, at almost 9% vs. 0.7%.

In a propensity matching analysis, Dr. Devani matched 53,000 pairs of acute pancreatitis patients with and without AKI. This determined that those with AKI faced a doubling in the risk of in-hospital mortality.

He also examined temporal trends with regard to the complication. The rate of diagnosed AKI in hospitalized acute pancreatitis cases rose dramatically, from 4% in 2002 to 11.6% in 2012. However, mortality in acute pancreatitis patients decreased among both those with AKI (17%-6%) and those without (1%-0.4%).

The mean length of stay in patients with AKI and pancreatitis likewise fell, from 14.8 to 8.6 days. Not surprisingly, total hospitalization cost for these patients fell as well ($42,975-$20,716).

Among pancreatitis patients without AKI, length of stay and costs declined, although not as dramatically as they did among AKI patients (6-5 days; $13,654-$10,895).

Dr. Devani had no financial disclosures.

msullivan@frontlinemedcom.com

On Twitter @alz_gal

Around one-quarter of obese individuals who undergo Roux-en-Y gastric bypass had sustained, long-term remission of obesity, but far fewer achieved body mass index of under 25 kg/m² or maintained it over 5 years, new research suggests.

Researchers reported on the outcomes of a retrospective cohort study of 219 patients who underwent Roux-en-Y gastric bypass surgery at a single center between 2008 and 2010 and were followed for up to 7 years after the procedure.

SandraMatic/Thinkstock

Around one-quarter of obese individuals who undergo Roux-en-Y gastric bypass had sustained, long-term remission of obesity, but far fewer achieved body mass index of under 25 kg/m² or maintained it over 5 years, new research suggests.

Researchers reported on the outcomes of a retrospective cohort study of 219 patients who underwent Roux-en-Y gastric bypass surgery at a single center between 2008 and 2010 and were followed for up to 7 years after the procedure.

SandraMatic/Thinkstock

Around one-quarter of obese individuals who undergo Roux-en-Y gastric bypass had sustained, long-term remission of obesity, but far fewer achieved body mass index of under 25 kg/m² or maintained it over 5 years, new research suggests.

Researchers reported on the outcomes of a retrospective cohort study of 219 patients who underwent Roux-en-Y gastric bypass surgery at a single center between 2008 and 2010 and were followed for up to 7 years after the procedure.

SandraMatic/Thinkstock

SAN DIEGO – Readmission rates after discharge for patients with schizophrenia are notoriously high, with approximately a quarter of U.S. schizophrenia patients readmitted within 3 months, according to Paul A. Kurdyak, MD, PhD.

In Ontario, Canada, readmission rates for people with schizophrenia are 12.5% within 30 days of discharge. Paradoxically, however, these same patients receive less follow-up than people hospitalized for other psychiatric disorders, Dr. Kurdyak of the Institute for Clinical Evaluative Sciences in Toronto reported at the annual meeting of the American Psychiatric Association.

To explore the relationship between discharge, follow-up, and subsequent readmission in this population, he assessed the impact of physician follow-up in the month after discharge on readmission rates for schizophrenia patients, noting a lack of published evidence on whether or how it helps. “We try and use readmission as a general performance indicator, and we try and use postdischarge follow-up as a general indicator, but there was no evidence to determine whether seeing a physician following discharge has an impact on anything,” Dr. Kurdyak said.

He and his colleagues tracked primary care and outpatient psychiatric visits in the first 30 days after discharge for about 20,000 people who had been hospitalized with schizophrenia in Ontario. “We chose 30 days because we knew the rate of follow-up within 7 days was just so low,” he said.

He said more than one in three of these patients went more than 30 days without seeing any physician at all.

Schizophrenia patients “are individuals with really high needs, whose average length of stay is about 2 weeks,” he said. “It’s hard to stabilize somebody in 2 weeks, so to have so many of them drop off a cliff [after discharge] is not great.”

Another finding was that the patients who saw any doctor – whether their primary care physician or psychiatrist – saw reduced rates of readmission at 30-210 days after discharge.

Where the benefit of seeing a physician was seen in sharpest relief was among the patients deemed, by use of a validated scoring system, to be at highest risk for readmission. These patients, who made up two-thirds of the cohort, saw a 15% reduction in readmission if they’d had a visit with either a primary care physician or psychiatrist and a 19% reduction if they’d seen both types of physician relative to patients who had no physician follow-up post discharge.

“In the high-risk group, you see a very clear separation between those who saw no physician and those who saw any physician,” Dr. Kurdyak said.

Some of the limitations of the study included the fact that little was known about the quality of the follow-up physician visits or about clinical collaboration, the causes for lack of follow-up were not clear, and follow-up by nonphysician health personnel was not captured.

Nonetheless, Dr. Kurdyak said, “the moral of the story is [that] seeing a physician really differentiates from seeing no physician statistically and clinically.”

In Canada, he noted, “we like to feel comfortable with the idea of universal health care, but, when we take a closer look, we often see real inequities and disparities despite universal health care. I think this is one of these situations where, if readmission is an indicator of need, our ability to provide services to those in the greatest need falls short of the ideal.”

Dr. Kurdyak disclosed no conflicts of interest relevant to his research. 

SAN DIEGO – Readmission rates after discharge for patients with schizophrenia are notoriously high, with approximately a quarter of U.S. schizophrenia patients readmitted within 3 months, according to Paul A. Kurdyak, MD, PhD.

In Ontario, Canada, readmission rates for people with schizophrenia are 12.5% within 30 days of discharge. Paradoxically, however, these same patients receive less follow-up than people hospitalized for other psychiatric disorders, Dr. Kurdyak of the Institute for Clinical Evaluative Sciences in Toronto reported at the annual meeting of the American Psychiatric Association.

To explore the relationship between discharge, follow-up, and subsequent readmission in this population, he assessed the impact of physician follow-up in the month after discharge on readmission rates for schizophrenia patients, noting a lack of published evidence on whether or how it helps. “We try and use readmission as a general performance indicator, and we try and use postdischarge follow-up as a general indicator, but there was no evidence to determine whether seeing a physician following discharge has an impact on anything,” Dr. Kurdyak said.

He and his colleagues tracked primary care and outpatient psychiatric visits in the first 30 days after discharge for about 20,000 people who had been hospitalized with schizophrenia in Ontario. “We chose 30 days because we knew the rate of follow-up within 7 days was just so low,” he said.

He said more than one in three of these patients went more than 30 days without seeing any physician at all.

Schizophrenia patients “are individuals with really high needs, whose average length of stay is about 2 weeks,” he said. “It’s hard to stabilize somebody in 2 weeks, so to have so many of them drop off a cliff [after discharge] is not great.”

Another finding was that the patients who saw any doctor – whether their primary care physician or psychiatrist – saw reduced rates of readmission at 30-210 days after discharge.

Where the benefit of seeing a physician was seen in sharpest relief was among the patients deemed, by use of a validated scoring system, to be at highest risk for readmission. These patients, who made up two-thirds of the cohort, saw a 15% reduction in readmission if they’d had a visit with either a primary care physician or psychiatrist and a 19% reduction if they’d seen both types of physician relative to patients who had no physician follow-up post discharge.

“In the high-risk group, you see a very clear separation between those who saw no physician and those who saw any physician,” Dr. Kurdyak said.

Some of the limitations of the study included the fact that little was known about the quality of the follow-up physician visits or about clinical collaboration, the causes for lack of follow-up were not clear, and follow-up by nonphysician health personnel was not captured.

Nonetheless, Dr. Kurdyak said, “the moral of the story is [that] seeing a physician really differentiates from seeing no physician statistically and clinically.”

In Canada, he noted, “we like to feel comfortable with the idea of universal health care, but, when we take a closer look, we often see real inequities and disparities despite universal health care. I think this is one of these situations where, if readmission is an indicator of need, our ability to provide services to those in the greatest need falls short of the ideal.”

Dr. Kurdyak disclosed no conflicts of interest relevant to his research. 

SAN DIEGO – Readmission rates after discharge for patients with schizophrenia are notoriously high, with approximately a quarter of U.S. schizophrenia patients readmitted within 3 months, according to Paul A. Kurdyak, MD, PhD.

In Ontario, Canada, readmission rates for people with schizophrenia are 12.5% within 30 days of discharge. Paradoxically, however, these same patients receive less follow-up than people hospitalized for other psychiatric disorders, Dr. Kurdyak of the Institute for Clinical Evaluative Sciences in Toronto reported at the annual meeting of the American Psychiatric Association.

To explore the relationship between discharge, follow-up, and subsequent readmission in this population, he assessed the impact of physician follow-up in the month after discharge on readmission rates for schizophrenia patients, noting a lack of published evidence on whether or how it helps. “We try and use readmission as a general performance indicator, and we try and use postdischarge follow-up as a general indicator, but there was no evidence to determine whether seeing a physician following discharge has an impact on anything,” Dr. Kurdyak said.

He and his colleagues tracked primary care and outpatient psychiatric visits in the first 30 days after discharge for about 20,000 people who had been hospitalized with schizophrenia in Ontario. “We chose 30 days because we knew the rate of follow-up within 7 days was just so low,” he said.

He said more than one in three of these patients went more than 30 days without seeing any physician at all.

Schizophrenia patients “are individuals with really high needs, whose average length of stay is about 2 weeks,” he said. “It’s hard to stabilize somebody in 2 weeks, so to have so many of them drop off a cliff [after discharge] is not great.”

Another finding was that the patients who saw any doctor – whether their primary care physician or psychiatrist – saw reduced rates of readmission at 30-210 days after discharge.

Where the benefit of seeing a physician was seen in sharpest relief was among the patients deemed, by use of a validated scoring system, to be at highest risk for readmission. These patients, who made up two-thirds of the cohort, saw a 15% reduction in readmission if they’d had a visit with either a primary care physician or psychiatrist and a 19% reduction if they’d seen both types of physician relative to patients who had no physician follow-up post discharge.

“In the high-risk group, you see a very clear separation between those who saw no physician and those who saw any physician,” Dr. Kurdyak said.

Some of the limitations of the study included the fact that little was known about the quality of the follow-up physician visits or about clinical collaboration, the causes for lack of follow-up were not clear, and follow-up by nonphysician health personnel was not captured.

Nonetheless, Dr. Kurdyak said, “the moral of the story is [that] seeing a physician really differentiates from seeing no physician statistically and clinically.”

In Canada, he noted, “we like to feel comfortable with the idea of universal health care, but, when we take a closer look, we often see real inequities and disparities despite universal health care. I think this is one of these situations where, if readmission is an indicator of need, our ability to provide services to those in the greatest need falls short of the ideal.”

Dr. Kurdyak disclosed no conflicts of interest relevant to his research.