Thrombus

Image by Andre E.X. Brown

The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has recommended approval for 2 biosimilars of the low-molecular-weight heparin enoxaparin.

Both of the agents, Inhixa and Thorinane, are intended to prevent and treat thrombosis-related disorders in adults.

The CHMP’s recommendations will be reviewed by the European Commission.

If the recommendations are formally adopted, Inhixa and Thorinane will be approved for use in the European Union as well as Norway, Liechtenstein, and Iceland.

Both Inhixa and Thorinane are indicated for:

• Prophylaxis of venous thromboembolism (VTE), particularly in patients undergoing orthopedic, general, or oncological surgery.
• VTE prophylaxis in patients bedridden due to acute illnesses, including acute heart failure, acute respiratory failure, severe infections, and exacerbation of rheumatic diseases causing immobilization of the patient (applies to strengths of 40 mg/0.4 mL).
• Treatment of deep vein thrombosis, complicated or uncomplicated by pulmonary embolism.
• Treatment of unstable angina and non-Q wave myocardial infarction, in combination with acetylsalicylic acid.
• Treatment of acute ST segment elevation myocardial infarction, including patients who will be treated conservatively or who will later undergo percutaneous coronary angioplasty (applies to strengths of 60 mg/0.6 mL, 80 mg/0.8 mL, and 100 mg/1 mL).
• VTE prevention in the extracorporeal circulation during hemodialysis.

If approved, Inhixa will be available as a solution for injection—2000 IU (20 mg) in 0.2 mL, 4000 IU (40 mg) in 0.4 mL, 6000 IU (60 mg) in 0.6 mL, 8000 IU (80 mg) in 0.8 mL, and 10,000 IU (100 mg) in 1 mL.

And Thorinane will be available as a solution for injection—2000 IU (20 mg) in 0.2 mL, 4000 IU (40 mg) in 0.4 mL, 6000 IU (60 mg) in 0.6 mL, 8000 IU (80 mg) in 0.8 mL, and 10,000 IU (100 mg) in 1 mL.

Inhixa is being developed by Techdow Europe AB, and Thorinane is being developed by Pharmathen S.A.

Thrombus

Image by Andre E.X. Brown

The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has recommended approval for 2 biosimilars of the low-molecular-weight heparin enoxaparin.

Both of the agents, Inhixa and Thorinane, are intended to prevent and treat thrombosis-related disorders in adults.

The CHMP’s recommendations will be reviewed by the European Commission.

If the recommendations are formally adopted, Inhixa and Thorinane will be approved for use in the European Union as well as Norway, Liechtenstein, and Iceland.

Both Inhixa and Thorinane are indicated for:

• Prophylaxis of venous thromboembolism (VTE), particularly in patients undergoing orthopedic, general, or oncological surgery.
• VTE prophylaxis in patients bedridden due to acute illnesses, including acute heart failure, acute respiratory failure, severe infections, and exacerbation of rheumatic diseases causing immobilization of the patient (applies to strengths of 40 mg/0.4 mL).
• Treatment of deep vein thrombosis, complicated or uncomplicated by pulmonary embolism.
• Treatment of unstable angina and non-Q wave myocardial infarction, in combination with acetylsalicylic acid.
• Treatment of acute ST segment elevation myocardial infarction, including patients who will be treated conservatively or who will later undergo percutaneous coronary angioplasty (applies to strengths of 60 mg/0.6 mL, 80 mg/0.8 mL, and 100 mg/1 mL).
• VTE prevention in the extracorporeal circulation during hemodialysis.

If approved, Inhixa will be available as a solution for injection—2000 IU (20 mg) in 0.2 mL, 4000 IU (40 mg) in 0.4 mL, 6000 IU (60 mg) in 0.6 mL, 8000 IU (80 mg) in 0.8 mL, and 10,000 IU (100 mg) in 1 mL.

And Thorinane will be available as a solution for injection—2000 IU (20 mg) in 0.2 mL, 4000 IU (40 mg) in 0.4 mL, 6000 IU (60 mg) in 0.6 mL, 8000 IU (80 mg) in 0.8 mL, and 10,000 IU (100 mg) in 1 mL.

Inhixa is being developed by Techdow Europe AB, and Thorinane is being developed by Pharmathen S.A.

Thrombus

Image by Andre E.X. Brown

The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has recommended approval for 2 biosimilars of the low-molecular-weight heparin enoxaparin.

Both of the agents, Inhixa and Thorinane, are intended to prevent and treat thrombosis-related disorders in adults.

The CHMP’s recommendations will be reviewed by the European Commission.

If the recommendations are formally adopted, Inhixa and Thorinane will be approved for use in the European Union as well as Norway, Liechtenstein, and Iceland.

Both Inhixa and Thorinane are indicated for:

• Prophylaxis of venous thromboembolism (VTE), particularly in patients undergoing orthopedic, general, or oncological surgery.
• VTE prophylaxis in patients bedridden due to acute illnesses, including acute heart failure, acute respiratory failure, severe infections, and exacerbation of rheumatic diseases causing immobilization of the patient (applies to strengths of 40 mg/0.4 mL).
• Treatment of deep vein thrombosis, complicated or uncomplicated by pulmonary embolism.
• Treatment of unstable angina and non-Q wave myocardial infarction, in combination with acetylsalicylic acid.
• Treatment of acute ST segment elevation myocardial infarction, including patients who will be treated conservatively or who will later undergo percutaneous coronary angioplasty (applies to strengths of 60 mg/0.6 mL, 80 mg/0.8 mL, and 100 mg/1 mL).
• VTE prevention in the extracorporeal circulation during hemodialysis.

If approved, Inhixa will be available as a solution for injection—2000 IU (20 mg) in 0.2 mL, 4000 IU (40 mg) in 0.4 mL, 6000 IU (60 mg) in 0.6 mL, 8000 IU (80 mg) in 0.8 mL, and 10,000 IU (100 mg) in 1 mL.

And Thorinane will be available as a solution for injection—2000 IU (20 mg) in 0.2 mL, 4000 IU (40 mg) in 0.4 mL, 6000 IU (60 mg) in 0.6 mL, 8000 IU (80 mg) in 0.8 mL, and 10,000 IU (100 mg) in 1 mL.

Inhixa is being developed by Techdow Europe AB, and Thorinane is being developed by Pharmathen S.A.

MIAMI – Diabetes mellitus, hypothyroidism, Cushing’s disease, and osteoporosis occur more frequently in people with psoriatic arthritis than in controls, a large cohort study reveals. Prevalence of these endocrine conditions was greater in a group of 3,161 patients with psoriatic arthritis, compared with 31,610 matched controls.

“We recommend that physicians should be aware of comorbid associations to provide comprehensive medical care to patients with psoriatic arthritis,” said Amir Haddad, MD, of the department of rheumatology at Carmel Medical Center in Haifa, Israel.

Dr. Haddad and his colleagues, however, found no significant differences in the prevalence of hyperthyroidism, hypo- and hyperparathyroidism, hyperprolactinemia, Addison’s disease, diabetes insipidus, pituitary adenoma, or acromegaly between groups in this retrospective, cross-sectional study.

They identified 1,474 men and 1,687 women diagnosed with psoriatic disease from 2000 to 2013 using the Clalit health services database in Israel. This group was a mean of 58 years old and 53% were women. Each patient was matched with 10 age- and gender-matched controls without psoriatic disease for the study.

“This is, to our knowledge, one of the largest real-life cohorts of psoriatic patient registries,” Dr. Haddad said at the annual meeting of the Group for Research and Assessment of Psoriasis and Psoriatic Arthritis (GRAPPA).

In the psoriatic arthritis group versus controls, diabetes mellitus prevalence was 27.9% vs. 20.7%; for hypothyroidism it was 12.7% vs. 8.6%; and for Cushing’s disease it was 0.3% vs. 0.1%. All these differences were statically significant (P less than 0.0001). Osteoporosis prevalence also differed significantly between the psoriatic arthritis and control groups: 13.2% vs. 9.1% (P less than 0.001).

Greater awareness of nonskin and nonjoint comorbidities is important, Dr. Haddad said, because it can influence choice of therapy and management of patients with psoriatic arthritis.

The investigators also conducted univariate and multivariate regression analyses. Compared with controls, the results suggest psoriatic arthritis patients have a higher risk for diabetes mellitus (odds ratio, 1.48), hypothyroidism (OR, 1.56), and osteoporosis (OR, 1.52). The risk for Cushing’s disease was notably higher (OR, 5.31) in the univariate analysis.

Risks for these endocrine conditions remained higher for the psoriatic arthritis patients in a multivariate regression analysis as well. For example, risk for diabetes mellitus (OR, 1.30) remained after adjusting for age, gender, smoking, obesity, and steroid use. Risk of hypothyroidism (OR, 1.61) remained after adjusting for age and gender; risk of osteoporosis (OR, 1.50) after adjusting for age, gender, steroid use, and smoking; and risk of Cushing’s disease (OR, 3.79) after adjustment for age, gender, and steroid use.

The large, population-based cohort is a strength of the study. “We are now going back to see how many of these patients were seen by rheumatologists,” Dr. Haddad said. A lack of association with disease burden is a potential limitation, he added.

Thirty percent of patients were treated with biologics and about 67% with steroids. “That number treated with steroids seems high,” a meeting attendee commented. Dr. Haddad explained that it is the percentage ever treated with steroids, not necessarily currently on steroids.

In a separate session at the GRAPPA meeting addressing psoriatic disease treatment recommendations, an attendee asked about specific recommendations for comorbidities. For now, GRAPPA plans to include comorbidities within its overall recommendations, as it did in its most recent update, released in January 2016. A limited amount of data is a primary reason.

“As the evidence on comorbidities gets better, we may someday have separate recommendations for comorbidities,” said Laura Coates, MD, a clinical lecturer in rheumatology at the University of Leeds (England).

“The comorbidities are very important,” said Arthur F. Kavanaugh, MD, professor of medicine at the University of California, San Diego. “That’s trickier and deals with the international nature of GRAPPA. It’s hard to say, ‘Go see this specialist,’ because that might not be standard of care in that country.”

Dr. Haddad, Dr. Coates, and Dr. Kavanaugh reported having no relevant financial disclosures.

MIAMI – Diabetes mellitus, hypothyroidism, Cushing’s disease, and osteoporosis occur more frequently in people with psoriatic arthritis than in controls, a large cohort study reveals. Prevalence of these endocrine conditions was greater in a group of 3,161 patients with psoriatic arthritis, compared with 31,610 matched controls.

“We recommend that physicians should be aware of comorbid associations to provide comprehensive medical care to patients with psoriatic arthritis,” said Amir Haddad, MD, of the department of rheumatology at Carmel Medical Center in Haifa, Israel.

Dr. Haddad and his colleagues, however, found no significant differences in the prevalence of hyperthyroidism, hypo- and hyperparathyroidism, hyperprolactinemia, Addison’s disease, diabetes insipidus, pituitary adenoma, or acromegaly between groups in this retrospective, cross-sectional study.

They identified 1,474 men and 1,687 women diagnosed with psoriatic disease from 2000 to 2013 using the Clalit health services database in Israel. This group was a mean of 58 years old and 53% were women. Each patient was matched with 10 age- and gender-matched controls without psoriatic disease for the study.

“This is, to our knowledge, one of the largest real-life cohorts of psoriatic patient registries,” Dr. Haddad said at the annual meeting of the Group for Research and Assessment of Psoriasis and Psoriatic Arthritis (GRAPPA).

In the psoriatic arthritis group versus controls, diabetes mellitus prevalence was 27.9% vs. 20.7%; for hypothyroidism it was 12.7% vs. 8.6%; and for Cushing’s disease it was 0.3% vs. 0.1%. All these differences were statically significant (P less than 0.0001). Osteoporosis prevalence also differed significantly between the psoriatic arthritis and control groups: 13.2% vs. 9.1% (P less than 0.001).

Greater awareness of nonskin and nonjoint comorbidities is important, Dr. Haddad said, because it can influence choice of therapy and management of patients with psoriatic arthritis.

The investigators also conducted univariate and multivariate regression analyses. Compared with controls, the results suggest psoriatic arthritis patients have a higher risk for diabetes mellitus (odds ratio, 1.48), hypothyroidism (OR, 1.56), and osteoporosis (OR, 1.52). The risk for Cushing’s disease was notably higher (OR, 5.31) in the univariate analysis.

Risks for these endocrine conditions remained higher for the psoriatic arthritis patients in a multivariate regression analysis as well. For example, risk for diabetes mellitus (OR, 1.30) remained after adjusting for age, gender, smoking, obesity, and steroid use. Risk of hypothyroidism (OR, 1.61) remained after adjusting for age and gender; risk of osteoporosis (OR, 1.50) after adjusting for age, gender, steroid use, and smoking; and risk of Cushing’s disease (OR, 3.79) after adjustment for age, gender, and steroid use.

The large, population-based cohort is a strength of the study. “We are now going back to see how many of these patients were seen by rheumatologists,” Dr. Haddad said. A lack of association with disease burden is a potential limitation, he added.

Thirty percent of patients were treated with biologics and about 67% with steroids. “That number treated with steroids seems high,” a meeting attendee commented. Dr. Haddad explained that it is the percentage ever treated with steroids, not necessarily currently on steroids.

In a separate session at the GRAPPA meeting addressing psoriatic disease treatment recommendations, an attendee asked about specific recommendations for comorbidities. For now, GRAPPA plans to include comorbidities within its overall recommendations, as it did in its most recent update, released in January 2016. A limited amount of data is a primary reason.

“As the evidence on comorbidities gets better, we may someday have separate recommendations for comorbidities,” said Laura Coates, MD, a clinical lecturer in rheumatology at the University of Leeds (England).

“The comorbidities are very important,” said Arthur F. Kavanaugh, MD, professor of medicine at the University of California, San Diego. “That’s trickier and deals with the international nature of GRAPPA. It’s hard to say, ‘Go see this specialist,’ because that might not be standard of care in that country.”

Dr. Haddad, Dr. Coates, and Dr. Kavanaugh reported having no relevant financial disclosures.

MIAMI – Diabetes mellitus, hypothyroidism, Cushing’s disease, and osteoporosis occur more frequently in people with psoriatic arthritis than in controls, a large cohort study reveals. Prevalence of these endocrine conditions was greater in a group of 3,161 patients with psoriatic arthritis, compared with 31,610 matched controls.

“We recommend that physicians should be aware of comorbid associations to provide comprehensive medical care to patients with psoriatic arthritis,” said Amir Haddad, MD, of the department of rheumatology at Carmel Medical Center in Haifa, Israel.

Dr. Haddad and his colleagues, however, found no significant differences in the prevalence of hyperthyroidism, hypo- and hyperparathyroidism, hyperprolactinemia, Addison’s disease, diabetes insipidus, pituitary adenoma, or acromegaly between groups in this retrospective, cross-sectional study.

They identified 1,474 men and 1,687 women diagnosed with psoriatic disease from 2000 to 2013 using the Clalit health services database in Israel. This group was a mean of 58 years old and 53% were women. Each patient was matched with 10 age- and gender-matched controls without psoriatic disease for the study.

“This is, to our knowledge, one of the largest real-life cohorts of psoriatic patient registries,” Dr. Haddad said at the annual meeting of the Group for Research and Assessment of Psoriasis and Psoriatic Arthritis (GRAPPA).

In the psoriatic arthritis group versus controls, diabetes mellitus prevalence was 27.9% vs. 20.7%; for hypothyroidism it was 12.7% vs. 8.6%; and for Cushing’s disease it was 0.3% vs. 0.1%. All these differences were statically significant (P less than 0.0001). Osteoporosis prevalence also differed significantly between the psoriatic arthritis and control groups: 13.2% vs. 9.1% (P less than 0.001).

Greater awareness of nonskin and nonjoint comorbidities is important, Dr. Haddad said, because it can influence choice of therapy and management of patients with psoriatic arthritis.

The investigators also conducted univariate and multivariate regression analyses. Compared with controls, the results suggest psoriatic arthritis patients have a higher risk for diabetes mellitus (odds ratio, 1.48), hypothyroidism (OR, 1.56), and osteoporosis (OR, 1.52). The risk for Cushing’s disease was notably higher (OR, 5.31) in the univariate analysis.

Risks for these endocrine conditions remained higher for the psoriatic arthritis patients in a multivariate regression analysis as well. For example, risk for diabetes mellitus (OR, 1.30) remained after adjusting for age, gender, smoking, obesity, and steroid use. Risk of hypothyroidism (OR, 1.61) remained after adjusting for age and gender; risk of osteoporosis (OR, 1.50) after adjusting for age, gender, steroid use, and smoking; and risk of Cushing’s disease (OR, 3.79) after adjustment for age, gender, and steroid use.

The large, population-based cohort is a strength of the study. “We are now going back to see how many of these patients were seen by rheumatologists,” Dr. Haddad said. A lack of association with disease burden is a potential limitation, he added.

Thirty percent of patients were treated with biologics and about 67% with steroids. “That number treated with steroids seems high,” a meeting attendee commented. Dr. Haddad explained that it is the percentage ever treated with steroids, not necessarily currently on steroids.

In a separate session at the GRAPPA meeting addressing psoriatic disease treatment recommendations, an attendee asked about specific recommendations for comorbidities. For now, GRAPPA plans to include comorbidities within its overall recommendations, as it did in its most recent update, released in January 2016. A limited amount of data is a primary reason.

“As the evidence on comorbidities gets better, we may someday have separate recommendations for comorbidities,” said Laura Coates, MD, a clinical lecturer in rheumatology at the University of Leeds (England).

“The comorbidities are very important,” said Arthur F. Kavanaugh, MD, professor of medicine at the University of California, San Diego. “That’s trickier and deals with the international nature of GRAPPA. It’s hard to say, ‘Go see this specialist,’ because that might not be standard of care in that country.”

Dr. Haddad, Dr. Coates, and Dr. Kavanaugh reported having no relevant financial disclosures.

MIAMI – Diabetes mellitus, hypothyroidism, Cushing’s disease, and osteoporosis occur more frequently in people with psoriatic arthritis than in controls, a large cohort study reveals. Prevalence of these endocrine conditions was greater in a group of 3,161 patients with psoriatic arthritis, compared with 31,610 matched controls.

“We recommend that physicians should be aware of comorbid associations to provide comprehensive medical care to patients with psoriatic arthritis,” said Amir Haddad, MD, of the department of rheumatology at Carmel Medical Center in Haifa, Israel.

Dr. Haddad and his colleagues, however, found no significant differences in the prevalence of hyperthyroidism, hypo- and hyperparathyroidism, hyperprolactinemia, Addison’s disease, diabetes insipidus, pituitary adenoma, or acromegaly between groups in this retrospective, cross-sectional study.

They identified 1,474 men and 1,687 women diagnosed with psoriatic disease from 2000 to 2013 using the Clalit health services database in Israel. This group was a mean of 58 years old and 53% were women. Each patient was matched with 10 age- and gender-matched controls without psoriatic disease for the study.

“This is, to our knowledge, one of the largest real-life cohorts of psoriatic patient registries,” Dr. Haddad said at the annual meeting of the Group for Research and Assessment of Psoriasis and Psoriatic Arthritis (GRAPPA).

In the psoriatic arthritis group versus controls, diabetes mellitus prevalence was 27.9% vs. 20.7%; for hypothyroidism it was 12.7% vs. 8.6%; and for Cushing’s disease it was 0.3% vs. 0.1%. All these differences were statically significant (P less than 0.0001). Osteoporosis prevalence also differed significantly between the psoriatic arthritis and control groups: 13.2% vs. 9.1% (P less than 0.001).

Greater awareness of nonskin and nonjoint comorbidities is important, Dr. Haddad said, because it can influence choice of therapy and management of patients with psoriatic arthritis.

The investigators also conducted univariate and multivariate regression analyses. Compared with controls, the results suggest psoriatic arthritis patients have a higher risk for diabetes mellitus (odds ratio, 1.48), hypothyroidism (OR, 1.56), and osteoporosis (OR, 1.52). The risk for Cushing’s disease was notably higher (OR, 5.31) in the univariate analysis.

Risks for these endocrine conditions remained higher for the psoriatic arthritis patients in a multivariate regression analysis as well. For example, risk for diabetes mellitus (OR, 1.30) remained after adjusting for age, gender, smoking, obesity, and steroid use. Risk of hypothyroidism (OR, 1.61) remained after adjusting for age and gender; risk of osteoporosis (OR, 1.50) after adjusting for age, gender, steroid use, and smoking; and risk of Cushing’s disease (OR, 3.79) after adjustment for age, gender, and steroid use.

The large, population-based cohort is a strength of the study. “We are now going back to see how many of these patients were seen by rheumatologists,” Dr. Haddad said. A lack of association with disease burden is a potential limitation, he added.

Thirty percent of patients were treated with biologics and about 67% with steroids. “That number treated with steroids seems high,” a meeting attendee commented. Dr. Haddad explained that it is the percentage ever treated with steroids, not necessarily currently on steroids.

In a separate session at the GRAPPA meeting addressing psoriatic disease treatment recommendations, an attendee asked about specific recommendations for comorbidities. For now, GRAPPA plans to include comorbidities within its overall recommendations, as it did in its most recent update, released in January 2016. A limited amount of data is a primary reason.

“As the evidence on comorbidities gets better, we may someday have separate recommendations for comorbidities,” said Laura Coates, MD, a clinical lecturer in rheumatology at the University of Leeds (England).

“The comorbidities are very important,” said Arthur F. Kavanaugh, MD, professor of medicine at the University of California, San Diego. “That’s trickier and deals with the international nature of GRAPPA. It’s hard to say, ‘Go see this specialist,’ because that might not be standard of care in that country.”

Dr. Haddad, Dr. Coates, and Dr. Kavanaugh reported having no relevant financial disclosures.

MIAMI – Diabetes mellitus, hypothyroidism, Cushing’s disease, and osteoporosis occur more frequently in people with psoriatic arthritis than in controls, a large cohort study reveals. Prevalence of these endocrine conditions was greater in a group of 3,161 patients with psoriatic arthritis, compared with 31,610 matched controls.

“We recommend that physicians should be aware of comorbid associations to provide comprehensive medical care to patients with psoriatic arthritis,” said Amir Haddad, MD, of the department of rheumatology at Carmel Medical Center in Haifa, Israel.

Dr. Haddad and his colleagues, however, found no significant differences in the prevalence of hyperthyroidism, hypo- and hyperparathyroidism, hyperprolactinemia, Addison’s disease, diabetes insipidus, pituitary adenoma, or acromegaly between groups in this retrospective, cross-sectional study.

They identified 1,474 men and 1,687 women diagnosed with psoriatic disease from 2000 to 2013 using the Clalit health services database in Israel. This group was a mean of 58 years old and 53% were women. Each patient was matched with 10 age- and gender-matched controls without psoriatic disease for the study.

“This is, to our knowledge, one of the largest real-life cohorts of psoriatic patient registries,” Dr. Haddad said at the annual meeting of the Group for Research and Assessment of Psoriasis and Psoriatic Arthritis (GRAPPA).

In the psoriatic arthritis group versus controls, diabetes mellitus prevalence was 27.9% vs. 20.7%; for hypothyroidism it was 12.7% vs. 8.6%; and for Cushing’s disease it was 0.3% vs. 0.1%. All these differences were statically significant (P less than 0.0001). Osteoporosis prevalence also differed significantly between the psoriatic arthritis and control groups: 13.2% vs. 9.1% (P less than 0.001).

Greater awareness of nonskin and nonjoint comorbidities is important, Dr. Haddad said, because it can influence choice of therapy and management of patients with psoriatic arthritis.

The investigators also conducted univariate and multivariate regression analyses. Compared with controls, the results suggest psoriatic arthritis patients have a higher risk for diabetes mellitus (odds ratio, 1.48), hypothyroidism (OR, 1.56), and osteoporosis (OR, 1.52). The risk for Cushing’s disease was notably higher (OR, 5.31) in the univariate analysis.

Risks for these endocrine conditions remained higher for the psoriatic arthritis patients in a multivariate regression analysis as well. For example, risk for diabetes mellitus (OR, 1.30) remained after adjusting for age, gender, smoking, obesity, and steroid use. Risk of hypothyroidism (OR, 1.61) remained after adjusting for age and gender; risk of osteoporosis (OR, 1.50) after adjusting for age, gender, steroid use, and smoking; and risk of Cushing’s disease (OR, 3.79) after adjustment for age, gender, and steroid use.

The large, population-based cohort is a strength of the study. “We are now going back to see how many of these patients were seen by rheumatologists,” Dr. Haddad said. A lack of association with disease burden is a potential limitation, he added.

Thirty percent of patients were treated with biologics and about 67% with steroids. “That number treated with steroids seems high,” a meeting attendee commented. Dr. Haddad explained that it is the percentage ever treated with steroids, not necessarily currently on steroids.

In a separate session at the GRAPPA meeting addressing psoriatic disease treatment recommendations, an attendee asked about specific recommendations for comorbidities. For now, GRAPPA plans to include comorbidities within its overall recommendations, as it did in its most recent update, released in January 2016. A limited amount of data is a primary reason.

“As the evidence on comorbidities gets better, we may someday have separate recommendations for comorbidities,” said Laura Coates, MD, a clinical lecturer in rheumatology at the University of Leeds (England).

“The comorbidities are very important,” said Arthur F. Kavanaugh, MD, professor of medicine at the University of California, San Diego. “That’s trickier and deals with the international nature of GRAPPA. It’s hard to say, ‘Go see this specialist,’ because that might not be standard of care in that country.”

Dr. Haddad, Dr. Coates, and Dr. Kavanaugh reported having no relevant financial disclosures.

MIAMI – Diabetes mellitus, hypothyroidism, Cushing’s disease, and osteoporosis occur more frequently in people with psoriatic arthritis than in controls, a large cohort study reveals. Prevalence of these endocrine conditions was greater in a group of 3,161 patients with psoriatic arthritis, compared with 31,610 matched controls.

“We recommend that physicians should be aware of comorbid associations to provide comprehensive medical care to patients with psoriatic arthritis,” said Amir Haddad, MD, of the department of rheumatology at Carmel Medical Center in Haifa, Israel.

Dr. Haddad and his colleagues, however, found no significant differences in the prevalence of hyperthyroidism, hypo- and hyperparathyroidism, hyperprolactinemia, Addison’s disease, diabetes insipidus, pituitary adenoma, or acromegaly between groups in this retrospective, cross-sectional study.

They identified 1,474 men and 1,687 women diagnosed with psoriatic disease from 2000 to 2013 using the Clalit health services database in Israel. This group was a mean of 58 years old and 53% were women. Each patient was matched with 10 age- and gender-matched controls without psoriatic disease for the study.

“This is, to our knowledge, one of the largest real-life cohorts of psoriatic patient registries,” Dr. Haddad said at the annual meeting of the Group for Research and Assessment of Psoriasis and Psoriatic Arthritis (GRAPPA).

In the psoriatic arthritis group versus controls, diabetes mellitus prevalence was 27.9% vs. 20.7%; for hypothyroidism it was 12.7% vs. 8.6%; and for Cushing’s disease it was 0.3% vs. 0.1%. All these differences were statically significant (P less than 0.0001). Osteoporosis prevalence also differed significantly between the psoriatic arthritis and control groups: 13.2% vs. 9.1% (P less than 0.001).

Greater awareness of nonskin and nonjoint comorbidities is important, Dr. Haddad said, because it can influence choice of therapy and management of patients with psoriatic arthritis.

The investigators also conducted univariate and multivariate regression analyses. Compared with controls, the results suggest psoriatic arthritis patients have a higher risk for diabetes mellitus (odds ratio, 1.48), hypothyroidism (OR, 1.56), and osteoporosis (OR, 1.52). The risk for Cushing’s disease was notably higher (OR, 5.31) in the univariate analysis.

Risks for these endocrine conditions remained higher for the psoriatic arthritis patients in a multivariate regression analysis as well. For example, risk for diabetes mellitus (OR, 1.30) remained after adjusting for age, gender, smoking, obesity, and steroid use. Risk of hypothyroidism (OR, 1.61) remained after adjusting for age and gender; risk of osteoporosis (OR, 1.50) after adjusting for age, gender, steroid use, and smoking; and risk of Cushing’s disease (OR, 3.79) after adjustment for age, gender, and steroid use.

The large, population-based cohort is a strength of the study. “We are now going back to see how many of these patients were seen by rheumatologists,” Dr. Haddad said. A lack of association with disease burden is a potential limitation, he added.

Thirty percent of patients were treated with biologics and about 67% with steroids. “That number treated with steroids seems high,” a meeting attendee commented. Dr. Haddad explained that it is the percentage ever treated with steroids, not necessarily currently on steroids.

In a separate session at the GRAPPA meeting addressing psoriatic disease treatment recommendations, an attendee asked about specific recommendations for comorbidities. For now, GRAPPA plans to include comorbidities within its overall recommendations, as it did in its most recent update, released in January 2016. A limited amount of data is a primary reason.

“As the evidence on comorbidities gets better, we may someday have separate recommendations for comorbidities,” said Laura Coates, MD, a clinical lecturer in rheumatology at the University of Leeds (England).

“The comorbidities are very important,” said Arthur F. Kavanaugh, MD, professor of medicine at the University of California, San Diego. “That’s trickier and deals with the international nature of GRAPPA. It’s hard to say, ‘Go see this specialist,’ because that might not be standard of care in that country.”

Dr. Haddad, Dr. Coates, and Dr. Kavanaugh reported having no relevant financial disclosures.

Medicaid’s three most expensive drugs by spending per prescription were for treatment of hemophilia, with the cost leader coming in at almost $59,000, according to an analysis by the Kaiser Family Foundation covering 2014 and the first half of 2015.

The trio of hemophilia drugs was topped by NovoSeven RT (coagulation factor VIIa [recombinant]), with Koate-DVI (antihemophilic factor [human]) second at $57,000 per prescription and Feiba (anti-inhibitor coagulant complex) third at $48,000 for each prescription.

None of the Medicaid costs include rebates since those data are unavailable to the public, Kaiser noted.

The fourth and fifth most expensive drugs were Adagen (pegademase bovine), which is used in the treatment of severe combined immunodeficiency disease associated with a deficiency of adenosine deaminase and cost Medicaid $45,000 per prescription, and the multiple sclerosis drug HP Acthar (repository corticotropin), which went for almost $44,000 a prescription, Kaiser said in its analysis, which used State Drug Utilization Data that are part of the Medicaid Drug Rebate Program.

[email protected]

Medicaid’s three most expensive drugs by spending per prescription were for treatment of hemophilia, with the cost leader coming in at almost $59,000, according to an analysis by the Kaiser Family Foundation covering 2014 and the first half of 2015.

The trio of hemophilia drugs was topped by NovoSeven RT (coagulation factor VIIa [recombinant]), with Koate-DVI (antihemophilic factor [human]) second at $57,000 per prescription and Feiba (anti-inhibitor coagulant complex) third at $48,000 for each prescription.

None of the Medicaid costs include rebates since those data are unavailable to the public, Kaiser noted.

The fourth and fifth most expensive drugs were Adagen (pegademase bovine), which is used in the treatment of severe combined immunodeficiency disease associated with a deficiency of adenosine deaminase and cost Medicaid $45,000 per prescription, and the multiple sclerosis drug HP Acthar (repository corticotropin), which went for almost $44,000 a prescription, Kaiser said in its analysis, which used State Drug Utilization Data that are part of the Medicaid Drug Rebate Program.

[email protected]

Medicaid’s three most expensive drugs by spending per prescription were for treatment of hemophilia, with the cost leader coming in at almost $59,000, according to an analysis by the Kaiser Family Foundation covering 2014 and the first half of 2015.

The trio of hemophilia drugs was topped by NovoSeven RT (coagulation factor VIIa [recombinant]), with Koate-DVI (antihemophilic factor [human]) second at $57,000 per prescription and Feiba (anti-inhibitor coagulant complex) third at $48,000 for each prescription.

None of the Medicaid costs include rebates since those data are unavailable to the public, Kaiser noted.

The fourth and fifth most expensive drugs were Adagen (pegademase bovine), which is used in the treatment of severe combined immunodeficiency disease associated with a deficiency of adenosine deaminase and cost Medicaid $45,000 per prescription, and the multiple sclerosis drug HP Acthar (repository corticotropin), which went for almost $44,000 a prescription, Kaiser said in its analysis, which used State Drug Utilization Data that are part of the Medicaid Drug Rebate Program.

[email protected]

HELSINKI – A 6-month lifestyle intervention was associated with an increased natural conception rate in infertile anovulatory obese women, compared with infertile ovulatory obese women, although the rate of vaginal births of healthy singletons did not differ between the groups, according to subgroup analyses of the Lifestyle randomized controlled trial.

The findings, which confirm those in the overall study population and are likely explained by the beneficial effects of weight loss on the resumption of ovulation, have implications for managing obese women who are experiencing infertility, according to Anne van Oers, MD, of the University of Groningen (the Netherlands).

The Lifestyle trial – a multicenter study conducted in the Netherlands and published in 2016 – involved a 6-month lifestyle intervention preceding fertility treatment in obese infertile women. The intervention had no effect on the rate of vaginal births of healthy term singletons within 24 months versus immediate fertility treatment (relative risk, 0.77), although natural conceptions with an ongoing pregnancy did occur more often in the lifestyle intervention group (relative risk, 1.6).

For that study, conducted from 2009 to 2012, the investigators randomized 577 obese infertile women to either the 6-month lifestyle intervention followed by 18 months of infertility treatment or to immediate fertility treatment. Weight loss was 4.4 kg in the intervention group and 1.1 kg in the control group, Dr. van Oers said at the annual meeting of the European Society of Human Reproduction and Embryology.

For the subgroup analyses, the investigators focused on six groups based on age (those 36 years and older and those under age 36), ovulation status (those who were anovulatory and those who were ovulatory), and body mass index (those with a body-mass index (BMI) of 35 kg/m² or greater and those with BMI under 35).

In the 564 women who completed follow-up, only the rate of natural conception was improved by the preconception lifestyle intervention: This was true in most of the subgroups, but was most pronounced among anovulatory women (28% vs. 11.4% in ovulatory women who received the intervention), she said.

Obese women are known to be at increased risk of infertility and are less likely than nonobese women to conceive after fertility treatment. In one prior study, ovulating subfertile women with a BMI of 29 kg/m² or higher had a 4% lower pregnancy rate per kg/m² increase per year, compared with ovulatory subfertile women with a BMI below 29, Dr. van Oers noted.

Although the current findings are limited by the nature of the subgroup analyses – the main study was not powered on analyses of subgroups or interaction tests – the findings do suggest a benefit of lifestyle intervention in some women, she noted.

“Our findings that lifestyle intervention in obese women more often leads to natural conception, specifically in anovulatory women, should be used in their counseling before fertility treatment and could reasonably be offered as first-line treatment for anovulation in obese women,” she said in a written statement.

Of note, 22% of the women in the main study were unable to adhere to the lifestyle intervention despite intensive coaching, according to the study’s project leader, Annemieke Hoek, MD, PhD, also from the University of Groningen.

The women who did not complete the program were significantly less likely to become pregnant, and those who did complete the program were more likely to conceive naturally, compared with the women in the control group who received immediate fertility treatment, Dr. Hoek said, noting that, again, this effect was most pronounced in anovulatory women.

Dr. van Oers and Dr. Hoek reported having no financial disclosures.

[email protected]

HELSINKI – A 6-month lifestyle intervention was associated with an increased natural conception rate in infertile anovulatory obese women, compared with infertile ovulatory obese women, although the rate of vaginal births of healthy singletons did not differ between the groups, according to subgroup analyses of the Lifestyle randomized controlled trial.

The findings, which confirm those in the overall study population and are likely explained by the beneficial effects of weight loss on the resumption of ovulation, have implications for managing obese women who are experiencing infertility, according to Anne van Oers, MD, of the University of Groningen (the Netherlands).

The Lifestyle trial – a multicenter study conducted in the Netherlands and published in 2016 – involved a 6-month lifestyle intervention preceding fertility treatment in obese infertile women. The intervention had no effect on the rate of vaginal births of healthy term singletons within 24 months versus immediate fertility treatment (relative risk, 0.77), although natural conceptions with an ongoing pregnancy did occur more often in the lifestyle intervention group (relative risk, 1.6).

For that study, conducted from 2009 to 2012, the investigators randomized 577 obese infertile women to either the 6-month lifestyle intervention followed by 18 months of infertility treatment or to immediate fertility treatment. Weight loss was 4.4 kg in the intervention group and 1.1 kg in the control group, Dr. van Oers said at the annual meeting of the European Society of Human Reproduction and Embryology.

For the subgroup analyses, the investigators focused on six groups based on age (those 36 years and older and those under age 36), ovulation status (those who were anovulatory and those who were ovulatory), and body mass index (those with a body-mass index (BMI) of 35 kg/m² or greater and those with BMI under 35).

In the 564 women who completed follow-up, only the rate of natural conception was improved by the preconception lifestyle intervention: This was true in most of the subgroups, but was most pronounced among anovulatory women (28% vs. 11.4% in ovulatory women who received the intervention), she said.

Obese women are known to be at increased risk of infertility and are less likely than nonobese women to conceive after fertility treatment. In one prior study, ovulating subfertile women with a BMI of 29 kg/m² or higher had a 4% lower pregnancy rate per kg/m² increase per year, compared with ovulatory subfertile women with a BMI below 29, Dr. van Oers noted.

Although the current findings are limited by the nature of the subgroup analyses – the main study was not powered on analyses of subgroups or interaction tests – the findings do suggest a benefit of lifestyle intervention in some women, she noted.

“Our findings that lifestyle intervention in obese women more often leads to natural conception, specifically in anovulatory women, should be used in their counseling before fertility treatment and could reasonably be offered as first-line treatment for anovulation in obese women,” she said in a written statement.

Of note, 22% of the women in the main study were unable to adhere to the lifestyle intervention despite intensive coaching, according to the study’s project leader, Annemieke Hoek, MD, PhD, also from the University of Groningen.

The women who did not complete the program were significantly less likely to become pregnant, and those who did complete the program were more likely to conceive naturally, compared with the women in the control group who received immediate fertility treatment, Dr. Hoek said, noting that, again, this effect was most pronounced in anovulatory women.

Dr. van Oers and Dr. Hoek reported having no financial disclosures.

[email protected]

HELSINKI – A 6-month lifestyle intervention was associated with an increased natural conception rate in infertile anovulatory obese women, compared with infertile ovulatory obese women, although the rate of vaginal births of healthy singletons did not differ between the groups, according to subgroup analyses of the Lifestyle randomized controlled trial.

The findings, which confirm those in the overall study population and are likely explained by the beneficial effects of weight loss on the resumption of ovulation, have implications for managing obese women who are experiencing infertility, according to Anne van Oers, MD, of the University of Groningen (the Netherlands).

The Lifestyle trial – a multicenter study conducted in the Netherlands and published in 2016 – involved a 6-month lifestyle intervention preceding fertility treatment in obese infertile women. The intervention had no effect on the rate of vaginal births of healthy term singletons within 24 months versus immediate fertility treatment (relative risk, 0.77), although natural conceptions with an ongoing pregnancy did occur more often in the lifestyle intervention group (relative risk, 1.6).

For that study, conducted from 2009 to 2012, the investigators randomized 577 obese infertile women to either the 6-month lifestyle intervention followed by 18 months of infertility treatment or to immediate fertility treatment. Weight loss was 4.4 kg in the intervention group and 1.1 kg in the control group, Dr. van Oers said at the annual meeting of the European Society of Human Reproduction and Embryology.

For the subgroup analyses, the investigators focused on six groups based on age (those 36 years and older and those under age 36), ovulation status (those who were anovulatory and those who were ovulatory), and body mass index (those with a body-mass index (BMI) of 35 kg/m² or greater and those with BMI under 35).

In the 564 women who completed follow-up, only the rate of natural conception was improved by the preconception lifestyle intervention: This was true in most of the subgroups, but was most pronounced among anovulatory women (28% vs. 11.4% in ovulatory women who received the intervention), she said.

Obese women are known to be at increased risk of infertility and are less likely than nonobese women to conceive after fertility treatment. In one prior study, ovulating subfertile women with a BMI of 29 kg/m² or higher had a 4% lower pregnancy rate per kg/m² increase per year, compared with ovulatory subfertile women with a BMI below 29, Dr. van Oers noted.

Although the current findings are limited by the nature of the subgroup analyses – the main study was not powered on analyses of subgroups or interaction tests – the findings do suggest a benefit of lifestyle intervention in some women, she noted.

“Our findings that lifestyle intervention in obese women more often leads to natural conception, specifically in anovulatory women, should be used in their counseling before fertility treatment and could reasonably be offered as first-line treatment for anovulation in obese women,” she said in a written statement.

Of note, 22% of the women in the main study were unable to adhere to the lifestyle intervention despite intensive coaching, according to the study’s project leader, Annemieke Hoek, MD, PhD, also from the University of Groningen.

The women who did not complete the program were significantly less likely to become pregnant, and those who did complete the program were more likely to conceive naturally, compared with the women in the control group who received immediate fertility treatment, Dr. Hoek said, noting that, again, this effect was most pronounced in anovulatory women.

Dr. van Oers and Dr. Hoek reported having no financial disclosures.

[email protected]

The prevalence of diabetes among adolescents in the United States is estimated to be 0.8%, with more than a quarter of that group being undiagnosed, according to a research letter published in JAMA.

Using data from the National Health and Nutrition Examination Survey 2005-2014, Andy Menke, PhD, and colleagues estimated the prevalence of diabetes overall, undiagnosed disease, and prediabetes in adolescents aged 12-19 years.

©Tashatuvango/Thinkstockphotos.com

Of the 2,606 adolescents included in the analysis, 62 had diabetes, 20 were undiagnosed, and 512 had prediabetes. The weighted prevalence of diabetes was 0.8% (95% confidence interval, 0.6%-1.1%), of which 28.5% (95% CI, 16.4%-44.8%) was undiagnosed. The researchers defined undiagnosed diabetes as having no report of previous diagnosis but having a hemoglobin A_1c level of 6.5% or greater, a fasting plasma glucose level of 126 mg/dL or greater, or a 2-hour plasma glucose level of 200 mg/dL or greater.

The prevalence of prediabetes among the adolescent sample was 17.7% (95% CI, 15.8%-19.8%). Prediabetes was defined as a hemoglobin A_1c level of 5.7%-6.4%, a fasting plasma glucose level of 100-125 mg/dL, or a 2-hour plasma glucose level of 140-199 mg/dL among adolescents who did not have diagnosed or undiagnosed diabetes.

“A relatively large proportion was unaware of the condition, particularly among non-Hispanic black participants and Hispanic participants, indicating a need for improved diabetes screening among adolescents,” the researchers wrote. “These findings may have important public health implications because diabetes in youth is associated with early onset of risk factors and complications.”

The researchers were unable to distinguish between types of diabetes, but they noted that previous research in adolescents found that 87% had type 1.

Read the full research letter in JAMA (2016;316[3]:344-5. doi:10.1001/jama.2016.8544).

The prevalence of diabetes among adolescents in the United States is estimated to be 0.8%, with more than a quarter of that group being undiagnosed, according to a research letter published in JAMA.

Using data from the National Health and Nutrition Examination Survey 2005-2014, Andy Menke, PhD, and colleagues estimated the prevalence of diabetes overall, undiagnosed disease, and prediabetes in adolescents aged 12-19 years.

©Tashatuvango/Thinkstockphotos.com

Of the 2,606 adolescents included in the analysis, 62 had diabetes, 20 were undiagnosed, and 512 had prediabetes. The weighted prevalence of diabetes was 0.8% (95% confidence interval, 0.6%-1.1%), of which 28.5% (95% CI, 16.4%-44.8%) was undiagnosed. The researchers defined undiagnosed diabetes as having no report of previous diagnosis but having a hemoglobin A_1c level of 6.5% or greater, a fasting plasma glucose level of 126 mg/dL or greater, or a 2-hour plasma glucose level of 200 mg/dL or greater.

The prevalence of prediabetes among the adolescent sample was 17.7% (95% CI, 15.8%-19.8%). Prediabetes was defined as a hemoglobin A_1c level of 5.7%-6.4%, a fasting plasma glucose level of 100-125 mg/dL, or a 2-hour plasma glucose level of 140-199 mg/dL among adolescents who did not have diagnosed or undiagnosed diabetes.

“A relatively large proportion was unaware of the condition, particularly among non-Hispanic black participants and Hispanic participants, indicating a need for improved diabetes screening among adolescents,” the researchers wrote. “These findings may have important public health implications because diabetes in youth is associated with early onset of risk factors and complications.”

The researchers were unable to distinguish between types of diabetes, but they noted that previous research in adolescents found that 87% had type 1.

Read the full research letter in JAMA (2016;316[3]:344-5. doi:10.1001/jama.2016.8544).

The prevalence of diabetes among adolescents in the United States is estimated to be 0.8%, with more than a quarter of that group being undiagnosed, according to a research letter published in JAMA.

Using data from the National Health and Nutrition Examination Survey 2005-2014, Andy Menke, PhD, and colleagues estimated the prevalence of diabetes overall, undiagnosed disease, and prediabetes in adolescents aged 12-19 years.

©Tashatuvango/Thinkstockphotos.com

Of the 2,606 adolescents included in the analysis, 62 had diabetes, 20 were undiagnosed, and 512 had prediabetes. The weighted prevalence of diabetes was 0.8% (95% confidence interval, 0.6%-1.1%), of which 28.5% (95% CI, 16.4%-44.8%) was undiagnosed. The researchers defined undiagnosed diabetes as having no report of previous diagnosis but having a hemoglobin A_1c level of 6.5% or greater, a fasting plasma glucose level of 126 mg/dL or greater, or a 2-hour plasma glucose level of 200 mg/dL or greater.

The prevalence of prediabetes among the adolescent sample was 17.7% (95% CI, 15.8%-19.8%). Prediabetes was defined as a hemoglobin A_1c level of 5.7%-6.4%, a fasting plasma glucose level of 100-125 mg/dL, or a 2-hour plasma glucose level of 140-199 mg/dL among adolescents who did not have diagnosed or undiagnosed diabetes.

“A relatively large proportion was unaware of the condition, particularly among non-Hispanic black participants and Hispanic participants, indicating a need for improved diabetes screening among adolescents,” the researchers wrote. “These findings may have important public health implications because diabetes in youth is associated with early onset of risk factors and complications.”

The researchers were unable to distinguish between types of diabetes, but they noted that previous research in adolescents found that 87% had type 1.

Read the full research letter in JAMA (2016;316[3]:344-5. doi:10.1001/jama.2016.8544).

The prevalence of diabetes among adolescents in the United States is estimated to be 0.8%, with more than a quarter of that group being undiagnosed, according to a research letter published in JAMA.

Using data from the National Health and Nutrition Examination Survey 2005-2014, Andy Menke, PhD, and colleagues estimated the prevalence of diabetes overall, undiagnosed disease, and prediabetes in adolescents aged 12-19 years.

©Tashatuvango/Thinkstockphotos.com

Of the 2,606 adolescents included in the analysis, 62 had diabetes, 20 were undiagnosed, and 512 had prediabetes. The weighted prevalence of diabetes was 0.8% (95% confidence interval, 0.6%-1.1%), of which 28.5% (95% CI, 16.4%-44.8%) was undiagnosed. The researchers defined undiagnosed diabetes as having no report of previous diagnosis but having a hemoglobin A_1c level of 6.5% or greater, a fasting plasma glucose level of 126 mg/dL or greater, or a 2-hour plasma glucose level of 200 mg/dL or greater.

The prevalence of prediabetes among the adolescent sample was 17.7% (95% CI, 15.8%-19.8%). Prediabetes was defined as a hemoglobin A_1c level of 5.7%-6.4%, a fasting plasma glucose level of 100-125 mg/dL, or a 2-hour plasma glucose level of 140-199 mg/dL among adolescents who did not have diagnosed or undiagnosed diabetes.

“A relatively large proportion was unaware of the condition, particularly among non-Hispanic black participants and Hispanic participants, indicating a need for improved diabetes screening among adolescents,” the researchers wrote. “These findings may have important public health implications because diabetes in youth is associated with early onset of risk factors and complications.”

The researchers were unable to distinguish between types of diabetes, but they noted that previous research in adolescents found that 87% had type 1.

Read the full research letter in JAMA (2016;316[3]:344-5. doi:10.1001/jama.2016.8544).

[email protected]

The prevalence of diabetes among adolescents in the United States is estimated to be 0.8%, with more than a quarter of that group being undiagnosed, according to a research letter published in JAMA.

Using data from the National Health and Nutrition Examination Survey 2005-2014, Andy Menke, PhD, and colleagues estimated the prevalence of diabetes overall, undiagnosed disease, and prediabetes in adolescents aged 12-19 years.

©Tashatuvango/Thinkstockphotos.com

Of the 2,606 adolescents included in the analysis, 62 had diabetes, 20 were undiagnosed, and 512 had prediabetes. The weighted prevalence of diabetes was 0.8% (95% confidence interval, 0.6%-1.1%), of which 28.5% (95% CI, 16.4%-44.8%) was undiagnosed. The researchers defined undiagnosed diabetes as having no report of previous diagnosis but having a hemoglobin A_1c level of 6.5% or greater, a fasting plasma glucose level of 126 mg/dL or greater, or a 2-hour plasma glucose level of 200 mg/dL or greater.

The prevalence of prediabetes among the adolescent sample was 17.7% (95% CI, 15.8%-19.8%). Prediabetes was defined as a hemoglobin A_1c level of 5.7%-6.4%, a fasting plasma glucose level of 100-125 mg/dL, or a 2-hour plasma glucose level of 140-199 mg/dL among adolescents who did not have diagnosed or undiagnosed diabetes.

“A relatively large proportion was unaware of the condition, particularly among non-Hispanic black participants and Hispanic participants, indicating a need for improved diabetes screening among adolescents,” the researchers wrote. “These findings may have important public health implications because diabetes in youth is associated with early onset of risk factors and complications.”

The researchers were unable to distinguish between types of diabetes, but they noted that previous research in adolescents found that 87% had type 1.

Read the full research letter in JAMA (2016;316[3]:344-5. doi:10.1001/jama.2016.8544).

[email protected]

The prevalence of diabetes among adolescents in the United States is estimated to be 0.8%, with more than a quarter of that group being undiagnosed, according to a research letter published in JAMA.

Using data from the National Health and Nutrition Examination Survey 2005-2014, Andy Menke, PhD, and colleagues estimated the prevalence of diabetes overall, undiagnosed disease, and prediabetes in adolescents aged 12-19 years.

©Tashatuvango/Thinkstockphotos.com

Of the 2,606 adolescents included in the analysis, 62 had diabetes, 20 were undiagnosed, and 512 had prediabetes. The weighted prevalence of diabetes was 0.8% (95% confidence interval, 0.6%-1.1%), of which 28.5% (95% CI, 16.4%-44.8%) was undiagnosed. The researchers defined undiagnosed diabetes as having no report of previous diagnosis but having a hemoglobin A_1c level of 6.5% or greater, a fasting plasma glucose level of 126 mg/dL or greater, or a 2-hour plasma glucose level of 200 mg/dL or greater.

The prevalence of prediabetes among the adolescent sample was 17.7% (95% CI, 15.8%-19.8%). Prediabetes was defined as a hemoglobin A_1c level of 5.7%-6.4%, a fasting plasma glucose level of 100-125 mg/dL, or a 2-hour plasma glucose level of 140-199 mg/dL among adolescents who did not have diagnosed or undiagnosed diabetes.

“A relatively large proportion was unaware of the condition, particularly among non-Hispanic black participants and Hispanic participants, indicating a need for improved diabetes screening among adolescents,” the researchers wrote. “These findings may have important public health implications because diabetes in youth is associated with early onset of risk factors and complications.”

The researchers were unable to distinguish between types of diabetes, but they noted that previous research in adolescents found that 87% had type 1.

Read the full research letter in JAMA (2016;316[3]:344-5. doi:10.1001/jama.2016.8544).

[email protected]

DENVER – Weight loss enhances responsiveness of patients with psoriatic arthritis to tumor necrosis factor inhibitors and should be part of routine care when using these drugs in this setting, Lianne Gensler, MD, said at an educational symposium organized by the Spondyloarthritis Research and Treatment Network.

She cited results from a randomized study conducted in Naples, Italy, with 138 patients and published in 2014, which showed the greater the weight loss of patients with psoriatic arthritis (PsA) during their first 6 months on treatment with a tumor necrosis factor (TNF) inhibitor, the greater their rate of achieving minimal disease activity by the end of the first 6 months.

Patients achieving a 5%-10% weight loss in the first 6 months on TNF-inhibitor treatment had a nearly fourfold increased rate of minimally active disease, compared with patients who had anything less than a 5% weight loss (including patients who may have had no weight change or gained weight). Those who lost more than 10% of their starting weight had a nearly sevenfold higher rate of achieving minimal disease activity, compared with those who had anything less than a 5% weight loss (Ann Rheum Dis. 2014 June;73[6]:1157-62).

“I use this result in my routine practice when starting patients on a TNF inhibitor or when patients are not responding to TNF-inhibitor treatment,” said Dr. Gensler, director of the ankylosing spondylitis clinic at the University of California, San Francisco.

“It’s a patient-centered approach to improving outcomes,” she said at the symposium, also organized by the Group for the Research and Assessment of Psoriasis and Psoriatic Arthritis (GRAPPA).

The 2015 guidelines (Arthritis Rheum. 2016 May;68[5]:1060-71) for managing psoriasis and PsA from GRAPPA cite the Naples data to recommend that all PsA patients be encouraged to achieve and maintain a healthy body weight, she noted.

The evidence that weight can affect TNF-inhibitor response in PsA patients first dates to a prior report from the same Naples group, which prospectively followed 270 PsA patients starting a TNF-inhibitor regimen, including 135 obese patients and 135 at normal weight. After 12 months, 36% of patients had minimal disease activity. The obese patients were nearly fivefold more likely to not achieve minimal disease activity during the first 12 months on treatment, compared with the normal-weight patients (Arthritis Care Res. 2013 Jan;65[1]:141-7). Obesity also was linked with a significantly increased risk that patients who achieved minimal disease activity after 1 year would relapse by 2-year follow-up.

“These studies have provided a new reason for [PsA] patients to lose weight,” agreed Atul A. Deodhar, MD, professor of medicine and medical director of the rheumatology clinics at the Oregon Health and Science University in Portland. “Before we counseled patients to lose weight for other reasons. Now there is a rheumatologic reason.”

Smoking cessation is another lifestyle step recently shown to improve TNF-inhibitor response in PsA patients, Dr. Deodhar added. For example, results from a recent Danish study of 1,388 PsA patients enrolled in the Danish national registry showed that smokers had significantly worse responses, compared with nonsmokers, during their first 6 months on a TNF-inhibitor regimen (Ann Rheum Dis. 2015 Dec;74[12]:2130-6).

Both weight loss and smoking cessation “have a powerful effect. I use these results in my practice to counsel patients to stop smoking and lose weight [for] those going on a TNF inhibitor, or when a TNF inhibitor is not working,” Dr. Deodhar said in an interview.

[email protected]

On Twitter @mitchelzoler

DENVER – Weight loss enhances responsiveness of patients with psoriatic arthritis to tumor necrosis factor inhibitors and should be part of routine care when using these drugs in this setting, Lianne Gensler, MD, said at an educational symposium organized by the Spondyloarthritis Research and Treatment Network.

She cited results from a randomized study conducted in Naples, Italy, with 138 patients and published in 2014, which showed the greater the weight loss of patients with psoriatic arthritis (PsA) during their first 6 months on treatment with a tumor necrosis factor (TNF) inhibitor, the greater their rate of achieving minimal disease activity by the end of the first 6 months.

Patients achieving a 5%-10% weight loss in the first 6 months on TNF-inhibitor treatment had a nearly fourfold increased rate of minimally active disease, compared with patients who had anything less than a 5% weight loss (including patients who may have had no weight change or gained weight). Those who lost more than 10% of their starting weight had a nearly sevenfold higher rate of achieving minimal disease activity, compared with those who had anything less than a 5% weight loss (Ann Rheum Dis. 2014 June;73[6]:1157-62).

“I use this result in my routine practice when starting patients on a TNF inhibitor or when patients are not responding to TNF-inhibitor treatment,” said Dr. Gensler, director of the ankylosing spondylitis clinic at the University of California, San Francisco.

“It’s a patient-centered approach to improving outcomes,” she said at the symposium, also organized by the Group for the Research and Assessment of Psoriasis and Psoriatic Arthritis (GRAPPA).

The 2015 guidelines (Arthritis Rheum. 2016 May;68[5]:1060-71) for managing psoriasis and PsA from GRAPPA cite the Naples data to recommend that all PsA patients be encouraged to achieve and maintain a healthy body weight, she noted.

The evidence that weight can affect TNF-inhibitor response in PsA patients first dates to a prior report from the same Naples group, which prospectively followed 270 PsA patients starting a TNF-inhibitor regimen, including 135 obese patients and 135 at normal weight. After 12 months, 36% of patients had minimal disease activity. The obese patients were nearly fivefold more likely to not achieve minimal disease activity during the first 12 months on treatment, compared with the normal-weight patients (Arthritis Care Res. 2013 Jan;65[1]:141-7). Obesity also was linked with a significantly increased risk that patients who achieved minimal disease activity after 1 year would relapse by 2-year follow-up.

“These studies have provided a new reason for [PsA] patients to lose weight,” agreed Atul A. Deodhar, MD, professor of medicine and medical director of the rheumatology clinics at the Oregon Health and Science University in Portland. “Before we counseled patients to lose weight for other reasons. Now there is a rheumatologic reason.”

Smoking cessation is another lifestyle step recently shown to improve TNF-inhibitor response in PsA patients, Dr. Deodhar added. For example, results from a recent Danish study of 1,388 PsA patients enrolled in the Danish national registry showed that smokers had significantly worse responses, compared with nonsmokers, during their first 6 months on a TNF-inhibitor regimen (Ann Rheum Dis. 2015 Dec;74[12]:2130-6).

Both weight loss and smoking cessation “have a powerful effect. I use these results in my practice to counsel patients to stop smoking and lose weight [for] those going on a TNF inhibitor, or when a TNF inhibitor is not working,” Dr. Deodhar said in an interview.

[email protected]

On Twitter @mitchelzoler

DENVER – Weight loss enhances responsiveness of patients with psoriatic arthritis to tumor necrosis factor inhibitors and should be part of routine care when using these drugs in this setting, Lianne Gensler, MD, said at an educational symposium organized by the Spondyloarthritis Research and Treatment Network.

She cited results from a randomized study conducted in Naples, Italy, with 138 patients and published in 2014, which showed the greater the weight loss of patients with psoriatic arthritis (PsA) during their first 6 months on treatment with a tumor necrosis factor (TNF) inhibitor, the greater their rate of achieving minimal disease activity by the end of the first 6 months.

Patients achieving a 5%-10% weight loss in the first 6 months on TNF-inhibitor treatment had a nearly fourfold increased rate of minimally active disease, compared with patients who had anything less than a 5% weight loss (including patients who may have had no weight change or gained weight). Those who lost more than 10% of their starting weight had a nearly sevenfold higher rate of achieving minimal disease activity, compared with those who had anything less than a 5% weight loss (Ann Rheum Dis. 2014 June;73[6]:1157-62).

“I use this result in my routine practice when starting patients on a TNF inhibitor or when patients are not responding to TNF-inhibitor treatment,” said Dr. Gensler, director of the ankylosing spondylitis clinic at the University of California, San Francisco.

“It’s a patient-centered approach to improving outcomes,” she said at the symposium, also organized by the Group for the Research and Assessment of Psoriasis and Psoriatic Arthritis (GRAPPA).

The 2015 guidelines (Arthritis Rheum. 2016 May;68[5]:1060-71) for managing psoriasis and PsA from GRAPPA cite the Naples data to recommend that all PsA patients be encouraged to achieve and maintain a healthy body weight, she noted.

The evidence that weight can affect TNF-inhibitor response in PsA patients first dates to a prior report from the same Naples group, which prospectively followed 270 PsA patients starting a TNF-inhibitor regimen, including 135 obese patients and 135 at normal weight. After 12 months, 36% of patients had minimal disease activity. The obese patients were nearly fivefold more likely to not achieve minimal disease activity during the first 12 months on treatment, compared with the normal-weight patients (Arthritis Care Res. 2013 Jan;65[1]:141-7). Obesity also was linked with a significantly increased risk that patients who achieved minimal disease activity after 1 year would relapse by 2-year follow-up.

“These studies have provided a new reason for [PsA] patients to lose weight,” agreed Atul A. Deodhar, MD, professor of medicine and medical director of the rheumatology clinics at the Oregon Health and Science University in Portland. “Before we counseled patients to lose weight for other reasons. Now there is a rheumatologic reason.”

Smoking cessation is another lifestyle step recently shown to improve TNF-inhibitor response in PsA patients, Dr. Deodhar added. For example, results from a recent Danish study of 1,388 PsA patients enrolled in the Danish national registry showed that smokers had significantly worse responses, compared with nonsmokers, during their first 6 months on a TNF-inhibitor regimen (Ann Rheum Dis. 2015 Dec;74[12]:2130-6).

Both weight loss and smoking cessation “have a powerful effect. I use these results in my practice to counsel patients to stop smoking and lose weight [for] those going on a TNF inhibitor, or when a TNF inhibitor is not working,” Dr. Deodhar said in an interview.

[email protected]

On Twitter @mitchelzoler

Concomitant administration of the meningococcal serogroup B vaccine bivalent rLP2086 with the diphtheria, tetanus, and acellular pertussis and inactivated poliovirus (DTaP/IPV) vaccine produced a immunologically noninferior response in adolescents, compared with administration of DTaP/IPV alone.

Timo Vesikari, MD, PhD, of the University of Tampere (Finland) Medical School and his associates randomized healthy adolescents aged 11-18 years to receive either bivalent rLP2086 plus DTaP/IPV (373 patients) or DTaP/IPV plus saline (376 patients). The researchers achieved the primary objective of the study – demonstrating the noninferiority of rLP2086 with DTaP/IPV. The lower bound of the two-sided 95% confidence interval for the difference in the proportion of responders between the two groups 1 month after the DTaP/IPV dose was greater than –10% for the nine DTaP/IPV antigens. Levels of antibodies to the DTaP/IPV antigens, measured as geometric means, also were similar between the vaccine groups for each antigen, according to the researchers.

©Alex Raths/thinkstockphotos.com

There also were substantial immune responses to bivalent rLP2086 plus DTaP/IPV, as measured with serum bactericidal assays using human complement (hSBAs) 1 month after the second vaccination, which increased even more after the third vaccination. The proportions of bivalent rLP2086-plus-DTaP/IPV recipients with prespecified seroprotective hSBA titers to the four meningococcal serogroup B test strains were between 55.5% and 97.3% after vaccination two and between 81.5% and 100% after vaccination three.

“Bivalent rLP2086 was well tolerated and elicited substantial and broad bactericidal responses to diverse [meningococcal serogroup B] strains in a high proportion of recipients after 2 vaccinations, and these responses were further enhanced after 3 vaccinations,” the researchers wrote.

Read the full study in the Journal of the Pediatric Infectious Diseases Society (2016 Jun;5[2]:180-7. doi: 10.1093/jpids/piv064).

[email protected]

Concomitant administration of the meningococcal serogroup B vaccine bivalent rLP2086 with the diphtheria, tetanus, and acellular pertussis and inactivated poliovirus (DTaP/IPV) vaccine produced a immunologically noninferior response in adolescents, compared with administration of DTaP/IPV alone.

Timo Vesikari, MD, PhD, of the University of Tampere (Finland) Medical School and his associates randomized healthy adolescents aged 11-18 years to receive either bivalent rLP2086 plus DTaP/IPV (373 patients) or DTaP/IPV plus saline (376 patients). The researchers achieved the primary objective of the study – demonstrating the noninferiority of rLP2086 with DTaP/IPV. The lower bound of the two-sided 95% confidence interval for the difference in the proportion of responders between the two groups 1 month after the DTaP/IPV dose was greater than –10% for the nine DTaP/IPV antigens. Levels of antibodies to the DTaP/IPV antigens, measured as geometric means, also were similar between the vaccine groups for each antigen, according to the researchers.

©Alex Raths/thinkstockphotos.com

There also were substantial immune responses to bivalent rLP2086 plus DTaP/IPV, as measured with serum bactericidal assays using human complement (hSBAs) 1 month after the second vaccination, which increased even more after the third vaccination. The proportions of bivalent rLP2086-plus-DTaP/IPV recipients with prespecified seroprotective hSBA titers to the four meningococcal serogroup B test strains were between 55.5% and 97.3% after vaccination two and between 81.5% and 100% after vaccination three.

“Bivalent rLP2086 was well tolerated and elicited substantial and broad bactericidal responses to diverse [meningococcal serogroup B] strains in a high proportion of recipients after 2 vaccinations, and these responses were further enhanced after 3 vaccinations,” the researchers wrote.

Read the full study in the Journal of the Pediatric Infectious Diseases Society (2016 Jun;5[2]:180-7. doi: 10.1093/jpids/piv064).

[email protected]

Concomitant administration of the meningococcal serogroup B vaccine bivalent rLP2086 with the diphtheria, tetanus, and acellular pertussis and inactivated poliovirus (DTaP/IPV) vaccine produced a immunologically noninferior response in adolescents, compared with administration of DTaP/IPV alone.

Timo Vesikari, MD, PhD, of the University of Tampere (Finland) Medical School and his associates randomized healthy adolescents aged 11-18 years to receive either bivalent rLP2086 plus DTaP/IPV (373 patients) or DTaP/IPV plus saline (376 patients). The researchers achieved the primary objective of the study – demonstrating the noninferiority of rLP2086 with DTaP/IPV. The lower bound of the two-sided 95% confidence interval for the difference in the proportion of responders between the two groups 1 month after the DTaP/IPV dose was greater than –10% for the nine DTaP/IPV antigens. Levels of antibodies to the DTaP/IPV antigens, measured as geometric means, also were similar between the vaccine groups for each antigen, according to the researchers.

©Alex Raths/thinkstockphotos.com

There also were substantial immune responses to bivalent rLP2086 plus DTaP/IPV, as measured with serum bactericidal assays using human complement (hSBAs) 1 month after the second vaccination, which increased even more after the third vaccination. The proportions of bivalent rLP2086-plus-DTaP/IPV recipients with prespecified seroprotective hSBA titers to the four meningococcal serogroup B test strains were between 55.5% and 97.3% after vaccination two and between 81.5% and 100% after vaccination three.

“Bivalent rLP2086 was well tolerated and elicited substantial and broad bactericidal responses to diverse [meningococcal serogroup B] strains in a high proportion of recipients after 2 vaccinations, and these responses were further enhanced after 3 vaccinations,” the researchers wrote.

Read the full study in the Journal of the Pediatric Infectious Diseases Society (2016 Jun;5[2]:180-7. doi: 10.1093/jpids/piv064).

[email protected]

Child in Senegal

Photo by Sarah Mattison

Combination therapy with artesunate and mefloquine can safely and effectively treat children younger than 5 years of age with uncomplicated, Plasmodium falciparum malaria, according to a phase 4 study.

Researchers compared the artesunate-mefloquine combination with artemether-lumefantrine in a group of malaria-infected children in Africa.

Both combinations produced a cure rate of about 90%, and the rates of side effects such as vomiting and neurologic events were similar.

These results were published in The Lancet Infectious Diseases.

The study included 944 African children, ages 6 months to 5 years, who tested positive for malaria.

Roughly half the children were assigned to treatment with artemether-lumefantrine (n=472), and the other half were assigned to artesunate-mefloquine (n=473). Both groups were treated for 2 or 3 days, with doses adjusted for age, not weight.

At 63 days of follow-up, the cure rates were similar between the treatment groups—89.7% for artemether-lumefantrine and 90.9% for artesunate-mefloquine. For both groups, no parasites were found in the blood at 72 hours after the start of treatment.

The rates of malaria recurrence were similar between the groups. Reinfection occurred in 43.8% of patients in the artesunate–mefloquine group and 43.0% in the artemether–lumefantrine group. Recrudescence occurred in 3.9% and 4.4%, respectively.

There were no psychiatric events in either treatment group, and the rates of neurologic events were low—2.1% in the artesunate-mefloquine group and 1.1% in the artemether-lumefantrine group.

The incidence of vomiting was 15.3% in the artesunate-mefloquine group and 16.8% in the artemether-lumefantrine group. Vomiting was a focus because it lowers patient adherence and limits how much of the medicine is absorbed.

The researchers noted that artesunate-mefloquine is not used in Africa at present, even though it’s 1 of the 5 artemisinin-based combination therapies approved for malaria treatment by the World Health Organization.

The team said the results of this study support the deployment of fixed-dose artesunate–mefloquine in young children in Africa. And the findings should have important implications for health policy in sub-Saharan Africa.

Child in Senegal

Photo by Sarah Mattison

Combination therapy with artesunate and mefloquine can safely and effectively treat children younger than 5 years of age with uncomplicated, Plasmodium falciparum malaria, according to a phase 4 study.

Researchers compared the artesunate-mefloquine combination with artemether-lumefantrine in a group of malaria-infected children in Africa.

Both combinations produced a cure rate of about 90%, and the rates of side effects such as vomiting and neurologic events were similar.

These results were published in The Lancet Infectious Diseases.

The study included 944 African children, ages 6 months to 5 years, who tested positive for malaria.

Roughly half the children were assigned to treatment with artemether-lumefantrine (n=472), and the other half were assigned to artesunate-mefloquine (n=473). Both groups were treated for 2 or 3 days, with doses adjusted for age, not weight.

At 63 days of follow-up, the cure rates were similar between the treatment groups—89.7% for artemether-lumefantrine and 90.9% for artesunate-mefloquine. For both groups, no parasites were found in the blood at 72 hours after the start of treatment.

The rates of malaria recurrence were similar between the groups. Reinfection occurred in 43.8% of patients in the artesunate–mefloquine group and 43.0% in the artemether–lumefantrine group. Recrudescence occurred in 3.9% and 4.4%, respectively.

There were no psychiatric events in either treatment group, and the rates of neurologic events were low—2.1% in the artesunate-mefloquine group and 1.1% in the artemether-lumefantrine group.

The incidence of vomiting was 15.3% in the artesunate-mefloquine group and 16.8% in the artemether-lumefantrine group. Vomiting was a focus because it lowers patient adherence and limits how much of the medicine is absorbed.

The researchers noted that artesunate-mefloquine is not used in Africa at present, even though it’s 1 of the 5 artemisinin-based combination therapies approved for malaria treatment by the World Health Organization.

The team said the results of this study support the deployment of fixed-dose artesunate–mefloquine in young children in Africa. And the findings should have important implications for health policy in sub-Saharan Africa.

Child in Senegal

Photo by Sarah Mattison

Combination therapy with artesunate and mefloquine can safely and effectively treat children younger than 5 years of age with uncomplicated, Plasmodium falciparum malaria, according to a phase 4 study.

Researchers compared the artesunate-mefloquine combination with artemether-lumefantrine in a group of malaria-infected children in Africa.

Both combinations produced a cure rate of about 90%, and the rates of side effects such as vomiting and neurologic events were similar.

These results were published in The Lancet Infectious Diseases.

The study included 944 African children, ages 6 months to 5 years, who tested positive for malaria.

Roughly half the children were assigned to treatment with artemether-lumefantrine (n=472), and the other half were assigned to artesunate-mefloquine (n=473). Both groups were treated for 2 or 3 days, with doses adjusted for age, not weight.

At 63 days of follow-up, the cure rates were similar between the treatment groups—89.7% for artemether-lumefantrine and 90.9% for artesunate-mefloquine. For both groups, no parasites were found in the blood at 72 hours after the start of treatment.

The rates of malaria recurrence were similar between the groups. Reinfection occurred in 43.8% of patients in the artesunate–mefloquine group and 43.0% in the artemether–lumefantrine group. Recrudescence occurred in 3.9% and 4.4%, respectively.

There were no psychiatric events in either treatment group, and the rates of neurologic events were low—2.1% in the artesunate-mefloquine group and 1.1% in the artemether-lumefantrine group.

The incidence of vomiting was 15.3% in the artesunate-mefloquine group and 16.8% in the artemether-lumefantrine group. Vomiting was a focus because it lowers patient adherence and limits how much of the medicine is absorbed.

The researchers noted that artesunate-mefloquine is not used in Africa at present, even though it’s 1 of the 5 artemisinin-based combination therapies approved for malaria treatment by the World Health Organization.

The team said the results of this study support the deployment of fixed-dose artesunate–mefloquine in young children in Africa. And the findings should have important implications for health policy in sub-Saharan Africa.