Genetic counseling by telephone was noninferior to in-person counseling among women at increased risk of hereditary breast and/or ovarian cancer (HBOC) for all psychosocial, decision-making, and quality-of-life measures, investigators found.

In addition, genetic testing was more common among women who received in-person counseling and women who lived in rural settings.

Gio_tto/Thinkstock

“This trial provides important evidence that telephone genetic counseling for HBOC is noninferior to in-person counseling and can be delivered as safely as in-person counseling without an adverse effect on long-term psychological, quality-of-life, and decision-making outcomes,” according to Anita Kinney, Ph.D., of the University of New Mexico, Albuquerque, and her associates (J Clin Oncol. 2016 Jun. doi: 10.1200/JCO.2015.65.9557).

Investigators used the Utah Population Database and Utah Cancer Registry to identify breast and ovarian cancer survivors and their at-risk female relatives with deleterious BRCA 1/2 mutations. Of the 988 women who met study requirements, 495 were randomly assigned to receive in-person genetic counseling, and 493 women were assigned to receive genetic counseling via telephone. All patients received counseling by a certified cancer genetic counselor according to standardized national protocols. Importantly, there were no significant differences in age, race/ethnicity, marital status, education level, rural vs. urban residence, income, employment status or health care coverage between the two study arms.

At the 1-year follow-up, there was no significant difference between patients receiving in-person or telephone counseling for all psychosocial and informed decision-making outcomes which included anxiety (average brief symptom inventory scores, 2.37 vs. 2.74), cancer-specific distress (average impact of event scores, 10.06 vs. 11.19), quality-of-life for physical health (average short form health survey scores, 50.54 vs. 49.75), quality-of-life for mental health (50.51 vs. 50.74), decisional conflict (average decisional conflict score, 26.88 vs. 26.76), decisional regret (average decision regret score, 21.38 vs. 21.07), and perceived personal control (average questionnaire scores, 1.53 vs. 1.52).

Genetic testing was more common among women who received in-person counseling (37.3% vs. 27.9%; 95% confidence interval comparing difference in testing uptake, 2.2%-16.8%). Interestingly, testing was higher for rural, compared with urban residents, for both telephone and in-person counseling.

This study received funding from the National Institutes of Health, the Huntsman Cancer Foundation, the University of New Mexico Comprehensive Cancer Center, and the University of Utah. Twelve of the investigators had no disclosures to report. Two investigators reported serving in advisory roles or receiving honoraria from Myriad Genetics or In Vitae.

[email protected]

On Twitter @jessnicolecraig

Genetic counseling by telephone was noninferior to in-person counseling among women at increased risk of hereditary breast and/or ovarian cancer (HBOC) for all psychosocial, decision-making, and quality-of-life measures, investigators found.

In addition, genetic testing was more common among women who received in-person counseling and women who lived in rural settings.

Gio_tto/Thinkstock

“This trial provides important evidence that telephone genetic counseling for HBOC is noninferior to in-person counseling and can be delivered as safely as in-person counseling without an adverse effect on long-term psychological, quality-of-life, and decision-making outcomes,” according to Anita Kinney, Ph.D., of the University of New Mexico, Albuquerque, and her associates (J Clin Oncol. 2016 Jun. doi: 10.1200/JCO.2015.65.9557).

Investigators used the Utah Population Database and Utah Cancer Registry to identify breast and ovarian cancer survivors and their at-risk female relatives with deleterious BRCA 1/2 mutations. Of the 988 women who met study requirements, 495 were randomly assigned to receive in-person genetic counseling, and 493 women were assigned to receive genetic counseling via telephone. All patients received counseling by a certified cancer genetic counselor according to standardized national protocols. Importantly, there were no significant differences in age, race/ethnicity, marital status, education level, rural vs. urban residence, income, employment status or health care coverage between the two study arms.

At the 1-year follow-up, there was no significant difference between patients receiving in-person or telephone counseling for all psychosocial and informed decision-making outcomes which included anxiety (average brief symptom inventory scores, 2.37 vs. 2.74), cancer-specific distress (average impact of event scores, 10.06 vs. 11.19), quality-of-life for physical health (average short form health survey scores, 50.54 vs. 49.75), quality-of-life for mental health (50.51 vs. 50.74), decisional conflict (average decisional conflict score, 26.88 vs. 26.76), decisional regret (average decision regret score, 21.38 vs. 21.07), and perceived personal control (average questionnaire scores, 1.53 vs. 1.52).

Genetic testing was more common among women who received in-person counseling (37.3% vs. 27.9%; 95% confidence interval comparing difference in testing uptake, 2.2%-16.8%). Interestingly, testing was higher for rural, compared with urban residents, for both telephone and in-person counseling.

This study received funding from the National Institutes of Health, the Huntsman Cancer Foundation, the University of New Mexico Comprehensive Cancer Center, and the University of Utah. Twelve of the investigators had no disclosures to report. Two investigators reported serving in advisory roles or receiving honoraria from Myriad Genetics or In Vitae.

[email protected]

On Twitter @jessnicolecraig

Genetic counseling by telephone was noninferior to in-person counseling among women at increased risk of hereditary breast and/or ovarian cancer (HBOC) for all psychosocial, decision-making, and quality-of-life measures, investigators found.

In addition, genetic testing was more common among women who received in-person counseling and women who lived in rural settings.

Gio_tto/Thinkstock

“This trial provides important evidence that telephone genetic counseling for HBOC is noninferior to in-person counseling and can be delivered as safely as in-person counseling without an adverse effect on long-term psychological, quality-of-life, and decision-making outcomes,” according to Anita Kinney, Ph.D., of the University of New Mexico, Albuquerque, and her associates (J Clin Oncol. 2016 Jun. doi: 10.1200/JCO.2015.65.9557).

Investigators used the Utah Population Database and Utah Cancer Registry to identify breast and ovarian cancer survivors and their at-risk female relatives with deleterious BRCA 1/2 mutations. Of the 988 women who met study requirements, 495 were randomly assigned to receive in-person genetic counseling, and 493 women were assigned to receive genetic counseling via telephone. All patients received counseling by a certified cancer genetic counselor according to standardized national protocols. Importantly, there were no significant differences in age, race/ethnicity, marital status, education level, rural vs. urban residence, income, employment status or health care coverage between the two study arms.

At the 1-year follow-up, there was no significant difference between patients receiving in-person or telephone counseling for all psychosocial and informed decision-making outcomes which included anxiety (average brief symptom inventory scores, 2.37 vs. 2.74), cancer-specific distress (average impact of event scores, 10.06 vs. 11.19), quality-of-life for physical health (average short form health survey scores, 50.54 vs. 49.75), quality-of-life for mental health (50.51 vs. 50.74), decisional conflict (average decisional conflict score, 26.88 vs. 26.76), decisional regret (average decision regret score, 21.38 vs. 21.07), and perceived personal control (average questionnaire scores, 1.53 vs. 1.52).

Genetic testing was more common among women who received in-person counseling (37.3% vs. 27.9%; 95% confidence interval comparing difference in testing uptake, 2.2%-16.8%). Interestingly, testing was higher for rural, compared with urban residents, for both telephone and in-person counseling.

This study received funding from the National Institutes of Health, the Huntsman Cancer Foundation, the University of New Mexico Comprehensive Cancer Center, and the University of Utah. Twelve of the investigators had no disclosures to report. Two investigators reported serving in advisory roles or receiving honoraria from Myriad Genetics or In Vitae.

[email protected]

On Twitter @jessnicolecraig

SCOTTSDALE, ARIZ. – Simple, effective, nonpharmacologic therapies can significantly augment pharmacotherapy for patients with treatment-resistant depression, according to Dr. Mark Hyman Rapaport.

More complex complementary approaches are being explored and may hold promise as part of the future of precision medicine, but well-tested strategies can still help many patients, he said.

Speaking at a session focused on treatment-resistant depression at a meeting of the American Society of Clinical Psychopharmacology, Dr. Rapaport, chairman of the department of psychiatry and behavioral sciences and Reunette W. Harris Professor at Emory University, Atlanta, began with the basics.

Citing a recent meta-analysis examining the way in which exercise works as a treatment for depression, Dr. Rapaport said, “looking at the world’s literature in a very thoughtful way, [the meta-analysis] did demonstrate a significant effect for aerobic exercise in decreasing signs and symptoms of depression.” The meta-analysis, he said, found that exercise provided the equivalent of a 5.07-point improvement on the Hamilton Rating Scale for Depression (HAM-D) (P = .0007). “I think it is something we should encourage our patients to use,” he said.

Similarly, though the treatments “have fallen out of favor,” Dr. Rapaport said “meta-analyses clearly demonstrate” a significant effect of bright white light (BL) therapy in seasonal affective disorder, both as monotherapy and in combination with antidepressants. The light should be dosed at 5000 lux or more for 1 hour daily.

Further, said Dr. Rapaport, BL as monotherapy or used in combination with antidepressants, or with sleep deprivation can be moderately effective in treating major depressive disorder. “It’s something to consider. We do not use it; we should use it,” Dr. Rapaport said. For patients with bipolar disorder, BL therapy can effectively augment medication use as well.

Focused, intensive treatment with light and sleep adjustments can be effective in both bipolar depression and treatment-resistant depression, Dr. Rapaport said. This approach, termed “adjunctive triple chronotherapy,” begins with total sleep deprivation for a period of 33-36 hours. Then, the patient receives BL therapy at 5,000 lux for at least 1 hour for 3 consecutive nights. Finally, patients are asked to advance their sleep phase for 3 days so that they sleep from 6 p.m. to 1 a.m. the 1st night, 8 p.m. to 3 a.m. the 2nd night, and 10 p.m. to 5 a.m. the 3rd night.

The triple chronotherapy approach, said Dr. Rapaport, results in a “rapid and sustained response, both in unipolar and bipolar depression, in the studies that have been done to date.”

Massage can effectively improve mood for individuals with depression as well. In a study of HIV-positive individuals with major depressive disorder and on stable medication, those who received weekly massage had a 33% decrease in HAM-D scores, compared with a 12% increase for those receiving light touch, and a 9% decrease for those on a wait list who received neither touch nor massage (P less than .05). The response rate of 40% for those receiving massage also was significantly higher than the 6.3% for those receiving light touch and the 14% for those on the wait list (P less than .05).

Recently completed unpublished work by Dr. Rapaport and his colleagues involving patients with generalized anxiety disorder also showed significantly greater improvement on a self-rating scale for anxiety for those receiving twice-weekly Swedish massage therapy, compared with those receiving light touch.

“Our patients – their symptoms aren’t just what we see on the monitors – they deal with quality of life, they deal with functioning,” said Dr. Rapaport, “so there are many things that we as clinicians need to look at,” he said at the meeting. “The key is this: There’s a slowly increasing but limited data set for [treatment-resistant depression]. We need to find the right treatments for the right subjects. “

The ASCP meeting was formerly known as the New Clinical Drug Evaluation Unit meeting. Dr. Rapaport reported no relevant financial conflicts.

[email protected]

On Twitter @karioakes

SCOTTSDALE, ARIZ. – Simple, effective, nonpharmacologic therapies can significantly augment pharmacotherapy for patients with treatment-resistant depression, according to Dr. Mark Hyman Rapaport.

More complex complementary approaches are being explored and may hold promise as part of the future of precision medicine, but well-tested strategies can still help many patients, he said.

Speaking at a session focused on treatment-resistant depression at a meeting of the American Society of Clinical Psychopharmacology, Dr. Rapaport, chairman of the department of psychiatry and behavioral sciences and Reunette W. Harris Professor at Emory University, Atlanta, began with the basics.

Citing a recent meta-analysis examining the way in which exercise works as a treatment for depression, Dr. Rapaport said, “looking at the world’s literature in a very thoughtful way, [the meta-analysis] did demonstrate a significant effect for aerobic exercise in decreasing signs and symptoms of depression.” The meta-analysis, he said, found that exercise provided the equivalent of a 5.07-point improvement on the Hamilton Rating Scale for Depression (HAM-D) (P = .0007). “I think it is something we should encourage our patients to use,” he said.

Similarly, though the treatments “have fallen out of favor,” Dr. Rapaport said “meta-analyses clearly demonstrate” a significant effect of bright white light (BL) therapy in seasonal affective disorder, both as monotherapy and in combination with antidepressants. The light should be dosed at 5000 lux or more for 1 hour daily.

Further, said Dr. Rapaport, BL as monotherapy or used in combination with antidepressants, or with sleep deprivation can be moderately effective in treating major depressive disorder. “It’s something to consider. We do not use it; we should use it,” Dr. Rapaport said. For patients with bipolar disorder, BL therapy can effectively augment medication use as well.

Focused, intensive treatment with light and sleep adjustments can be effective in both bipolar depression and treatment-resistant depression, Dr. Rapaport said. This approach, termed “adjunctive triple chronotherapy,” begins with total sleep deprivation for a period of 33-36 hours. Then, the patient receives BL therapy at 5,000 lux for at least 1 hour for 3 consecutive nights. Finally, patients are asked to advance their sleep phase for 3 days so that they sleep from 6 p.m. to 1 a.m. the 1st night, 8 p.m. to 3 a.m. the 2nd night, and 10 p.m. to 5 a.m. the 3rd night.

The triple chronotherapy approach, said Dr. Rapaport, results in a “rapid and sustained response, both in unipolar and bipolar depression, in the studies that have been done to date.”

Massage can effectively improve mood for individuals with depression as well. In a study of HIV-positive individuals with major depressive disorder and on stable medication, those who received weekly massage had a 33% decrease in HAM-D scores, compared with a 12% increase for those receiving light touch, and a 9% decrease for those on a wait list who received neither touch nor massage (P less than .05). The response rate of 40% for those receiving massage also was significantly higher than the 6.3% for those receiving light touch and the 14% for those on the wait list (P less than .05).

Recently completed unpublished work by Dr. Rapaport and his colleagues involving patients with generalized anxiety disorder also showed significantly greater improvement on a self-rating scale for anxiety for those receiving twice-weekly Swedish massage therapy, compared with those receiving light touch.

“Our patients – their symptoms aren’t just what we see on the monitors – they deal with quality of life, they deal with functioning,” said Dr. Rapaport, “so there are many things that we as clinicians need to look at,” he said at the meeting. “The key is this: There’s a slowly increasing but limited data set for [treatment-resistant depression]. We need to find the right treatments for the right subjects. “

The ASCP meeting was formerly known as the New Clinical Drug Evaluation Unit meeting. Dr. Rapaport reported no relevant financial conflicts.

[email protected]

On Twitter @karioakes

SCOTTSDALE, ARIZ. – Simple, effective, nonpharmacologic therapies can significantly augment pharmacotherapy for patients with treatment-resistant depression, according to Dr. Mark Hyman Rapaport.

More complex complementary approaches are being explored and may hold promise as part of the future of precision medicine, but well-tested strategies can still help many patients, he said.

Speaking at a session focused on treatment-resistant depression at a meeting of the American Society of Clinical Psychopharmacology, Dr. Rapaport, chairman of the department of psychiatry and behavioral sciences and Reunette W. Harris Professor at Emory University, Atlanta, began with the basics.

Citing a recent meta-analysis examining the way in which exercise works as a treatment for depression, Dr. Rapaport said, “looking at the world’s literature in a very thoughtful way, [the meta-analysis] did demonstrate a significant effect for aerobic exercise in decreasing signs and symptoms of depression.” The meta-analysis, he said, found that exercise provided the equivalent of a 5.07-point improvement on the Hamilton Rating Scale for Depression (HAM-D) (P = .0007). “I think it is something we should encourage our patients to use,” he said.

Similarly, though the treatments “have fallen out of favor,” Dr. Rapaport said “meta-analyses clearly demonstrate” a significant effect of bright white light (BL) therapy in seasonal affective disorder, both as monotherapy and in combination with antidepressants. The light should be dosed at 5000 lux or more for 1 hour daily.

Further, said Dr. Rapaport, BL as monotherapy or used in combination with antidepressants, or with sleep deprivation can be moderately effective in treating major depressive disorder. “It’s something to consider. We do not use it; we should use it,” Dr. Rapaport said. For patients with bipolar disorder, BL therapy can effectively augment medication use as well.

Focused, intensive treatment with light and sleep adjustments can be effective in both bipolar depression and treatment-resistant depression, Dr. Rapaport said. This approach, termed “adjunctive triple chronotherapy,” begins with total sleep deprivation for a period of 33-36 hours. Then, the patient receives BL therapy at 5,000 lux for at least 1 hour for 3 consecutive nights. Finally, patients are asked to advance their sleep phase for 3 days so that they sleep from 6 p.m. to 1 a.m. the 1st night, 8 p.m. to 3 a.m. the 2nd night, and 10 p.m. to 5 a.m. the 3rd night.

The triple chronotherapy approach, said Dr. Rapaport, results in a “rapid and sustained response, both in unipolar and bipolar depression, in the studies that have been done to date.”

Massage can effectively improve mood for individuals with depression as well. In a study of HIV-positive individuals with major depressive disorder and on stable medication, those who received weekly massage had a 33% decrease in HAM-D scores, compared with a 12% increase for those receiving light touch, and a 9% decrease for those on a wait list who received neither touch nor massage (P less than .05). The response rate of 40% for those receiving massage also was significantly higher than the 6.3% for those receiving light touch and the 14% for those on the wait list (P less than .05).

Recently completed unpublished work by Dr. Rapaport and his colleagues involving patients with generalized anxiety disorder also showed significantly greater improvement on a self-rating scale for anxiety for those receiving twice-weekly Swedish massage therapy, compared with those receiving light touch.

“Our patients – their symptoms aren’t just what we see on the monitors – they deal with quality of life, they deal with functioning,” said Dr. Rapaport, “so there are many things that we as clinicians need to look at,” he said at the meeting. “The key is this: There’s a slowly increasing but limited data set for [treatment-resistant depression]. We need to find the right treatments for the right subjects. “

The ASCP meeting was formerly known as the New Clinical Drug Evaluation Unit meeting. Dr. Rapaport reported no relevant financial conflicts.

[email protected]

On Twitter @karioakes

The Diagnosis: Irritated Seborrheic Keratosis

Biopsies of one of the protruding papules and the underlying plaque were performed. The specimen from the papule showed hyperkeratosis, acanthosis, papillomatosis, and a flattened dermoepidermal junction with demarcated horizontal margin, which demonstrated apparent upward growth of the epidermis. Moderate lymphocytic infiltration in the upper dermis also was observed (Figure, A). The histologic findings of the plaque showed acanthosis, several pseudohorn cysts, hyperpigmentation of the basal layer, and a horizontal demarcation of the dermoepidermal junction (Figure, B).

Seborrheic keratosis is the most common benign epidermal tumor of the skin with variable appearance.¹ It usually begins with well-circumscribed, dull, flat, tan or brown patches that then grow into waxy verrucous papules.¹ There are many clinicopathologic variants of SK such as common SK, stucco keratosis, and dermatosis papulosa nigra in clinical variation, as well as acanthotic, hyperkeratotic, clonal, reticulated, irritated, and melanoacanthoma subtypes based on histological variation.^2,3

Seborrheic keratosis is a tumor of keratinocytic origin. Although genetics, sun exposure,⁴ and human papillomavirus infection⁵ are thought to be causative factors, the precise etiology of SK is unknown.¹

The histology of SK shows monotonous basaloid tumor cells without atypia. It generally is comprised of focal acanthosis and papillomatosis with a sharp flat base. Intraepithelial horn pseudocysts are notable features of SK and increased melanin often is seen.^2,6

Irritated SK is a histologic variant of SK that has been mechanically or chemically irritated or is involved in immunologic responses. Histologically, the dermis underlying an SK lesion filled with a dense lymphocytic infiltration is characteristic.^1,2

For symptomatic or cosmetically undesirable lesions, complete removal of the lesion is the preferred treatment. Cryotherapy, electrodesiccation followed by curettage, curettage followed by desiccation, laser ablation, and surgical excision are effective treatments.¹

The Diagnosis: Irritated Seborrheic Keratosis

Biopsies of one of the protruding papules and the underlying plaque were performed. The specimen from the papule showed hyperkeratosis, acanthosis, papillomatosis, and a flattened dermoepidermal junction with demarcated horizontal margin, which demonstrated apparent upward growth of the epidermis. Moderate lymphocytic infiltration in the upper dermis also was observed (Figure, A). The histologic findings of the plaque showed acanthosis, several pseudohorn cysts, hyperpigmentation of the basal layer, and a horizontal demarcation of the dermoepidermal junction (Figure, B).

Seborrheic keratosis is the most common benign epidermal tumor of the skin with variable appearance.¹ It usually begins with well-circumscribed, dull, flat, tan or brown patches that then grow into waxy verrucous papules.¹ There are many clinicopathologic variants of SK such as common SK, stucco keratosis, and dermatosis papulosa nigra in clinical variation, as well as acanthotic, hyperkeratotic, clonal, reticulated, irritated, and melanoacanthoma subtypes based on histological variation.^2,3

Seborrheic keratosis is a tumor of keratinocytic origin. Although genetics, sun exposure,⁴ and human papillomavirus infection⁵ are thought to be causative factors, the precise etiology of SK is unknown.¹

The histology of SK shows monotonous basaloid tumor cells without atypia. It generally is comprised of focal acanthosis and papillomatosis with a sharp flat base. Intraepithelial horn pseudocysts are notable features of SK and increased melanin often is seen.^2,6

Irritated SK is a histologic variant of SK that has been mechanically or chemically irritated or is involved in immunologic responses. Histologically, the dermis underlying an SK lesion filled with a dense lymphocytic infiltration is characteristic.^1,2

For symptomatic or cosmetically undesirable lesions, complete removal of the lesion is the preferred treatment. Cryotherapy, electrodesiccation followed by curettage, curettage followed by desiccation, laser ablation, and surgical excision are effective treatments.¹

The Diagnosis: Irritated Seborrheic Keratosis

Biopsies of one of the protruding papules and the underlying plaque were performed. The specimen from the papule showed hyperkeratosis, acanthosis, papillomatosis, and a flattened dermoepidermal junction with demarcated horizontal margin, which demonstrated apparent upward growth of the epidermis. Moderate lymphocytic infiltration in the upper dermis also was observed (Figure, A). The histologic findings of the plaque showed acanthosis, several pseudohorn cysts, hyperpigmentation of the basal layer, and a horizontal demarcation of the dermoepidermal junction (Figure, B).

Seborrheic keratosis is the most common benign epidermal tumor of the skin with variable appearance.¹ It usually begins with well-circumscribed, dull, flat, tan or brown patches that then grow into waxy verrucous papules.¹ There are many clinicopathologic variants of SK such as common SK, stucco keratosis, and dermatosis papulosa nigra in clinical variation, as well as acanthotic, hyperkeratotic, clonal, reticulated, irritated, and melanoacanthoma subtypes based on histological variation.^2,3

Seborrheic keratosis is a tumor of keratinocytic origin. Although genetics, sun exposure,⁴ and human papillomavirus infection⁵ are thought to be causative factors, the precise etiology of SK is unknown.¹

The histology of SK shows monotonous basaloid tumor cells without atypia. It generally is comprised of focal acanthosis and papillomatosis with a sharp flat base. Intraepithelial horn pseudocysts are notable features of SK and increased melanin often is seen.^2,6

Irritated SK is a histologic variant of SK that has been mechanically or chemically irritated or is involved in immunologic responses. Histologically, the dermis underlying an SK lesion filled with a dense lymphocytic infiltration is characteristic.^1,2

For symptomatic or cosmetically undesirable lesions, complete removal of the lesion is the preferred treatment. Cryotherapy, electrodesiccation followed by curettage, curettage followed by desiccation, laser ablation, and surgical excision are effective treatments.¹

SAN DIEGO – Phentermine-topiramate was the most effective long-term weight loss drug, based on findings from a network meta-analysis from the University of California, San Diego.

The investigators pooled data from 28 studies of phentermine-topiramate (Qsymia) and four other drugs: orlistat (Xenical, Alli), lorcaserin (Belviq), naltrexone-bupropion (Contrave), and liraglutide (Victoza, Saxenda). The most commonly prescribed weight loss drug in the United States – generic phentermine – was not included because it’s not indicated for long-term use.

“It’s good to have a problem of plenty,” said Dr. Siddharth Singh, but it also makes it hard to figure out which drug to prescribe, especially given the lack of head-to-head studies. He said he hopes the results will help. However, the 30%-45% attrition rate across the studies means that the results have to be interpreted cautiously, said Dr. Singh, who is in the division of gastroenterology in the department of internal medicine, UCSD.

Most of the studies were company-funded phase III trials of weight loss drugs vs. placebo; the trials all were at least 1 year long and included more than 29,000 overweight or obese adults. The analysis was limited to patients on the maximum recommended dose of each drug.

All the drugs were more effective than placebo, but phentermine-topiramate was the most effective, with about 75% of patients losing at least 5% of their weight at 1 year and more than half losing at least 10%, with an average weight loss above placebo of 9 kg. Phentermine-topiramate patients were 10 times more likely than patients on placebo to hit the 5% mark at 1 year; liraglutide patients were 5.5 times more likely to do so; naltrexone-bupropion patients were 4 times more likely; lorcaserin patients, 3.1 times more likely; and orlistat patients, 2.7 times more likely to hit the 5% mark. The spread was similar for weight loss of 10% or more at 1 year vs. placebo.

Phentermine-topiramate’s tolerability profile was acceptable, with 10% of patients quitting the drug by 1 year because of adverse events. The best tolerated was lorcaserin, with a discontinuation rate of 6%, and the least tolerated was liraglutide, with a 13% discontinuation rate. Patients were more likely to quit active drug than placebo in all the studies.

Of course, there are other considerations, especially comorbidities; liraglutide might be the best choice in diabetics, for instance, and patients with psychiatric issues might want to avoid naltrexone-bupropion and lorcaserin, Dr. Singh said.

Subjects were a median of 46 years old, and 74% were women. The median body mass index was 36 kg/m². All the patients had lifestyle and nutrition counseling along with their study medications.

The investigators next plan to compare the drugs’ safety and efficacy in real world settings.

There was no industry funding for the work, and Dr. Singh had no relevant financial disclosures.

[email protected]

SAN DIEGO – Phentermine-topiramate was the most effective long-term weight loss drug, based on findings from a network meta-analysis from the University of California, San Diego.

The investigators pooled data from 28 studies of phentermine-topiramate (Qsymia) and four other drugs: orlistat (Xenical, Alli), lorcaserin (Belviq), naltrexone-bupropion (Contrave), and liraglutide (Victoza, Saxenda). The most commonly prescribed weight loss drug in the United States – generic phentermine – was not included because it’s not indicated for long-term use.

“It’s good to have a problem of plenty,” said Dr. Siddharth Singh, but it also makes it hard to figure out which drug to prescribe, especially given the lack of head-to-head studies. He said he hopes the results will help. However, the 30%-45% attrition rate across the studies means that the results have to be interpreted cautiously, said Dr. Singh, who is in the division of gastroenterology in the department of internal medicine, UCSD.

Most of the studies were company-funded phase III trials of weight loss drugs vs. placebo; the trials all were at least 1 year long and included more than 29,000 overweight or obese adults. The analysis was limited to patients on the maximum recommended dose of each drug.

All the drugs were more effective than placebo, but phentermine-topiramate was the most effective, with about 75% of patients losing at least 5% of their weight at 1 year and more than half losing at least 10%, with an average weight loss above placebo of 9 kg. Phentermine-topiramate patients were 10 times more likely than patients on placebo to hit the 5% mark at 1 year; liraglutide patients were 5.5 times more likely to do so; naltrexone-bupropion patients were 4 times more likely; lorcaserin patients, 3.1 times more likely; and orlistat patients, 2.7 times more likely to hit the 5% mark. The spread was similar for weight loss of 10% or more at 1 year vs. placebo.

Phentermine-topiramate’s tolerability profile was acceptable, with 10% of patients quitting the drug by 1 year because of adverse events. The best tolerated was lorcaserin, with a discontinuation rate of 6%, and the least tolerated was liraglutide, with a 13% discontinuation rate. Patients were more likely to quit active drug than placebo in all the studies.

Of course, there are other considerations, especially comorbidities; liraglutide might be the best choice in diabetics, for instance, and patients with psychiatric issues might want to avoid naltrexone-bupropion and lorcaserin, Dr. Singh said.

Subjects were a median of 46 years old, and 74% were women. The median body mass index was 36 kg/m². All the patients had lifestyle and nutrition counseling along with their study medications.

The investigators next plan to compare the drugs’ safety and efficacy in real world settings.

There was no industry funding for the work, and Dr. Singh had no relevant financial disclosures.

[email protected]

SAN DIEGO – Phentermine-topiramate was the most effective long-term weight loss drug, based on findings from a network meta-analysis from the University of California, San Diego.

The investigators pooled data from 28 studies of phentermine-topiramate (Qsymia) and four other drugs: orlistat (Xenical, Alli), lorcaserin (Belviq), naltrexone-bupropion (Contrave), and liraglutide (Victoza, Saxenda). The most commonly prescribed weight loss drug in the United States – generic phentermine – was not included because it’s not indicated for long-term use.

“It’s good to have a problem of plenty,” said Dr. Siddharth Singh, but it also makes it hard to figure out which drug to prescribe, especially given the lack of head-to-head studies. He said he hopes the results will help. However, the 30%-45% attrition rate across the studies means that the results have to be interpreted cautiously, said Dr. Singh, who is in the division of gastroenterology in the department of internal medicine, UCSD.

Most of the studies were company-funded phase III trials of weight loss drugs vs. placebo; the trials all were at least 1 year long and included more than 29,000 overweight or obese adults. The analysis was limited to patients on the maximum recommended dose of each drug.

All the drugs were more effective than placebo, but phentermine-topiramate was the most effective, with about 75% of patients losing at least 5% of their weight at 1 year and more than half losing at least 10%, with an average weight loss above placebo of 9 kg. Phentermine-topiramate patients were 10 times more likely than patients on placebo to hit the 5% mark at 1 year; liraglutide patients were 5.5 times more likely to do so; naltrexone-bupropion patients were 4 times more likely; lorcaserin patients, 3.1 times more likely; and orlistat patients, 2.7 times more likely to hit the 5% mark. The spread was similar for weight loss of 10% or more at 1 year vs. placebo.

Phentermine-topiramate’s tolerability profile was acceptable, with 10% of patients quitting the drug by 1 year because of adverse events. The best tolerated was lorcaserin, with a discontinuation rate of 6%, and the least tolerated was liraglutide, with a 13% discontinuation rate. Patients were more likely to quit active drug than placebo in all the studies.

Of course, there are other considerations, especially comorbidities; liraglutide might be the best choice in diabetics, for instance, and patients with psychiatric issues might want to avoid naltrexone-bupropion and lorcaserin, Dr. Singh said.

Subjects were a median of 46 years old, and 74% were women. The median body mass index was 36 kg/m². All the patients had lifestyle and nutrition counseling along with their study medications.

The investigators next plan to compare the drugs’ safety and efficacy in real world settings.

There was no industry funding for the work, and Dr. Singh had no relevant financial disclosures.

[email protected]

LONDON – Subcutaneous methotrexate monotherapy may be more effective at helping recently diagnosed patients with rheumatoid arthritis avoid biologic therapy, compared with similar patients on oral methotrexate, based on an analysis of data collected from 483 Canadian patients in routine care and enrolled in a national registry.

“This is a signal for improved efficacy with subcutaneous methotrexate, compared with oral methotrexate,” said Dr. Stephanie Gottheil, who reported these results at the European Congress of Rheumatology.

“In general, as long as patients with rheumatoid arthritis are under good control without a biologic drug, that is preferable” to initiating biologic treatment, said Dr. Gottheil, a researcher at Western University in London, Ont. Delaying the start of biologic treatment saves money, avoids the increased risk of infection that comes with biologic treatment, and defers a patient’s immune response to a biologic drug that can eventually compromise the biologic’s efficacy, she said in an interview.

“These data did not come from a randomized trial and so are by no means conclusive, but this is a signal that supports other data that subcutaneous methotrexate potentially puts patients into remission faster, and we know that earlier remission predicts more sustained remission,” she said.

“The biggest barrier to subcutaneous administration of methotrexate is patient preference to not inject themselves, but results from some studies have also shown that subcutaneous methotrexate is better tolerated,” compared with oral dosing, she added.

The study used data collected in the Canadian Early Arthritis Cohort (CATCH), which enrolls patients at several centers throughout Canada diagnosed with rheumatoid arthritis for less than 12 months. Dr. Gottheil and her associates particularly focused on 1,189 early RA patients with moderate to severe disease activity enrolled in CATCH during 2007-2012 who received methotrexate and had never previously received a biologic drug. The study’s primary endpoint was time to first treatment with a biologic during 3 years of follow-up after entry into the registry.

The patients’ average age at enrollment was 56 years, more than two-thirds were women, and their average methotrexate dosage was 20 mg/week. The cohort included 483 patients on methotrexate monotherapy – with virtually equal numbers on oral methotrexate and subcutaneous methotrexate – and 706 on a regimen that combined methotrexate with one or more additional (nonbiologic) drugs at baseline. The patients in each of the methotrexate monotherapy subgroups, those on oral or subcutaneous therapy, were very similar in their demographic and clinical profiles.

The analysis showed no statistically significant difference in time to first biologic use between the patients on a combination regimen and those on oral methotrexate monotherapy.

But when the researchers compared the time to first biologic among those on subcutaneous methotrexate monotherapy with those on oral methotrexate monotherapy, the subcutaneous patients showed a statistically significant, 47% reduced rate of starting any biologic drug during follow-up in an analysis that controlled for age, sex, education, comorbidities, disease duration, baseline disease activity, baseline corticosteroid use, joint erosions at baseline, and score on the health-assessment questionnaire at baseline, Dr. Gottheil reported.

The analysis also revealed three other variables that significantly linked with a slower progression to biologic treatment: older age, no use of corticosteroid treatment at baseline, and lower disease activity at baseline.

The CATCH registry research program is sponsored by AbbVie, Amgen, Bristol-Myers Squibb, Hoffmann-La Roche, Janssen, Pfizer, and UCB. Dr. Gottheil had no relevant disclosures.

[email protected]

On Twitter @mitchelzoler

LONDON – Subcutaneous methotrexate monotherapy may be more effective at helping recently diagnosed patients with rheumatoid arthritis avoid biologic therapy, compared with similar patients on oral methotrexate, based on an analysis of data collected from 483 Canadian patients in routine care and enrolled in a national registry.

“This is a signal for improved efficacy with subcutaneous methotrexate, compared with oral methotrexate,” said Dr. Stephanie Gottheil, who reported these results at the European Congress of Rheumatology.

“In general, as long as patients with rheumatoid arthritis are under good control without a biologic drug, that is preferable” to initiating biologic treatment, said Dr. Gottheil, a researcher at Western University in London, Ont. Delaying the start of biologic treatment saves money, avoids the increased risk of infection that comes with biologic treatment, and defers a patient’s immune response to a biologic drug that can eventually compromise the biologic’s efficacy, she said in an interview.

“These data did not come from a randomized trial and so are by no means conclusive, but this is a signal that supports other data that subcutaneous methotrexate potentially puts patients into remission faster, and we know that earlier remission predicts more sustained remission,” she said.

“The biggest barrier to subcutaneous administration of methotrexate is patient preference to not inject themselves, but results from some studies have also shown that subcutaneous methotrexate is better tolerated,” compared with oral dosing, she added.

The study used data collected in the Canadian Early Arthritis Cohort (CATCH), which enrolls patients at several centers throughout Canada diagnosed with rheumatoid arthritis for less than 12 months. Dr. Gottheil and her associates particularly focused on 1,189 early RA patients with moderate to severe disease activity enrolled in CATCH during 2007-2012 who received methotrexate and had never previously received a biologic drug. The study’s primary endpoint was time to first treatment with a biologic during 3 years of follow-up after entry into the registry.

The patients’ average age at enrollment was 56 years, more than two-thirds were women, and their average methotrexate dosage was 20 mg/week. The cohort included 483 patients on methotrexate monotherapy – with virtually equal numbers on oral methotrexate and subcutaneous methotrexate – and 706 on a regimen that combined methotrexate with one or more additional (nonbiologic) drugs at baseline. The patients in each of the methotrexate monotherapy subgroups, those on oral or subcutaneous therapy, were very similar in their demographic and clinical profiles.

The analysis showed no statistically significant difference in time to first biologic use between the patients on a combination regimen and those on oral methotrexate monotherapy.

But when the researchers compared the time to first biologic among those on subcutaneous methotrexate monotherapy with those on oral methotrexate monotherapy, the subcutaneous patients showed a statistically significant, 47% reduced rate of starting any biologic drug during follow-up in an analysis that controlled for age, sex, education, comorbidities, disease duration, baseline disease activity, baseline corticosteroid use, joint erosions at baseline, and score on the health-assessment questionnaire at baseline, Dr. Gottheil reported.

The analysis also revealed three other variables that significantly linked with a slower progression to biologic treatment: older age, no use of corticosteroid treatment at baseline, and lower disease activity at baseline.

The CATCH registry research program is sponsored by AbbVie, Amgen, Bristol-Myers Squibb, Hoffmann-La Roche, Janssen, Pfizer, and UCB. Dr. Gottheil had no relevant disclosures.

[email protected]

On Twitter @mitchelzoler

LONDON – Subcutaneous methotrexate monotherapy may be more effective at helping recently diagnosed patients with rheumatoid arthritis avoid biologic therapy, compared with similar patients on oral methotrexate, based on an analysis of data collected from 483 Canadian patients in routine care and enrolled in a national registry.

“This is a signal for improved efficacy with subcutaneous methotrexate, compared with oral methotrexate,” said Dr. Stephanie Gottheil, who reported these results at the European Congress of Rheumatology.

“In general, as long as patients with rheumatoid arthritis are under good control without a biologic drug, that is preferable” to initiating biologic treatment, said Dr. Gottheil, a researcher at Western University in London, Ont. Delaying the start of biologic treatment saves money, avoids the increased risk of infection that comes with biologic treatment, and defers a patient’s immune response to a biologic drug that can eventually compromise the biologic’s efficacy, she said in an interview.

“These data did not come from a randomized trial and so are by no means conclusive, but this is a signal that supports other data that subcutaneous methotrexate potentially puts patients into remission faster, and we know that earlier remission predicts more sustained remission,” she said.

“The biggest barrier to subcutaneous administration of methotrexate is patient preference to not inject themselves, but results from some studies have also shown that subcutaneous methotrexate is better tolerated,” compared with oral dosing, she added.

The study used data collected in the Canadian Early Arthritis Cohort (CATCH), which enrolls patients at several centers throughout Canada diagnosed with rheumatoid arthritis for less than 12 months. Dr. Gottheil and her associates particularly focused on 1,189 early RA patients with moderate to severe disease activity enrolled in CATCH during 2007-2012 who received methotrexate and had never previously received a biologic drug. The study’s primary endpoint was time to first treatment with a biologic during 3 years of follow-up after entry into the registry.

The patients’ average age at enrollment was 56 years, more than two-thirds were women, and their average methotrexate dosage was 20 mg/week. The cohort included 483 patients on methotrexate monotherapy – with virtually equal numbers on oral methotrexate and subcutaneous methotrexate – and 706 on a regimen that combined methotrexate with one or more additional (nonbiologic) drugs at baseline. The patients in each of the methotrexate monotherapy subgroups, those on oral or subcutaneous therapy, were very similar in their demographic and clinical profiles.

The analysis showed no statistically significant difference in time to first biologic use between the patients on a combination regimen and those on oral methotrexate monotherapy.

But when the researchers compared the time to first biologic among those on subcutaneous methotrexate monotherapy with those on oral methotrexate monotherapy, the subcutaneous patients showed a statistically significant, 47% reduced rate of starting any biologic drug during follow-up in an analysis that controlled for age, sex, education, comorbidities, disease duration, baseline disease activity, baseline corticosteroid use, joint erosions at baseline, and score on the health-assessment questionnaire at baseline, Dr. Gottheil reported.

The analysis also revealed three other variables that significantly linked with a slower progression to biologic treatment: older age, no use of corticosteroid treatment at baseline, and lower disease activity at baseline.

The CATCH registry research program is sponsored by AbbVie, Amgen, Bristol-Myers Squibb, Hoffmann-La Roche, Janssen, Pfizer, and UCB. Dr. Gottheil had no relevant disclosures.

[email protected]

On Twitter @mitchelzoler

LONDON – A EULAR task force issued the first update to recommendations for managing Behçet’s disease since 2008, with revised recommendations that reflect expanded use of biologic agents, and increased evidence to guide management of gastrointestinal involvement, use of anticoagulants in patients with venous involvement, and use of surgical and interventional treatments, Dr. Gülen Hatemi said while presenting the update at the European Congress of Rheumatology.

The task force, which included more than 20 members, identified 304 articles to apply to the update, and produced five overarching principal and 18 specific recommendations divided among six categories of clinical manifestations of Behçet’s disease, said Dr. Hatemi, convenor of the task force and a rheumatologist at Istanbul University.

Mitchel L. Zoler/Frontline Medical News

For mucocutaneous involvement, the update included five items that all received a “strong” recommendation from the task force: For an oral or genital ulcer, use a topical agent, such as a local steroid. Try colchicine first to prevent recurrent mucocutaneous lesions, especially when the dominant lesion is erythema nodosum or a genital ulcer. Treat papulopustular or acnelike lesions with topical or systemic agents, as when treating acne vulgaris. Coordinate treatment of leg ulcers, which can be caused by venous stasis or obliterative vasculitis, with a dermatologist and vascular surgeon. And azathioprine, thalidomide, interferon-alpha, a tumor necrosis factor (TNF)–alpha antagonist, or apremilast (Otezla) may be necessary for selected patients.

The task force issued two strong recommendations for managing eye involvement along with one conditional recommendation. The first strong recommendation was that managing uveitis requires close collaboration with an ophthalmologist, with the goal of inducing and maintaining remission. Patients with an inflammatory eye disease affecting the posterior segment should receive treatment with azathioprine, cyclosporine, interferon-alpha, or a monoclonal TNF-alpha antagonist. Treatment with a systemic corticosteroid should occur only when combined with azathioprine or another systemic immunosuppressant.

The second strong recommendation was that patients who present with an initial or recurrent acute episode of sight-threatening uveitis should receive treatment with a high-dose glucocorticoid, infliximab, or interferon-alpha. Intravitreal injection with a glucocorticoid as an adjunct to systemic therapy is an option for patients with a unilateral exacerbation. The conditional recommendation was for patients with isolated anterior uveitis. When these patients have markers of a poor prognosis – such as young age, male sex, or early disease onset – systemic treatment with an immunosuppressant is a possible option.

The panel issued three strong recommendations along with one conditional recommendation for managing vascular involvement. One of the strong recommendations called for treating acute deep vein thrombosis with a glucocorticoid as well as an immunosuppresant such as azathioprine, cyclophosphamide, or cyclosporine. A conditional recommendation said patients with refractory venous thrombosis could be considered for treatment with a monoclonal TNF-alpha antagonist, along with an anticoagulant if the patient’s risk for bleeding was generally low and a coexistent pulmonary artery aneurysm was ruled out.

Management of arterial aneurysms received the other two strong recommendations. The panel recommended high-dose glucocorticoid plus cyclophosphamide for a pulmonary artery aneurysm, followed by a monoclonal TNF-alpha antagonist for refractory cases. Patients with these aneurysms who are at high risk for major bleeding should undergo embolization in preference to open surgery. When patients have aortic or peripheral artery aneurysms, treatment should start with cyclophosphamide and a corticosteroid before an aneurysm repair is attempted. But surgery or stenting of the aneurysm should not be delayed when patients are symptomatic.

Gastrointestinal involvement received one strong and two conditional recommendations. The panel strongly recommended confirming gastrointestinal involvement using endoscopy, imaging, or both, while also ruling out treatment with a nonsteroidal anti-inflammatory drug, inflammatory bowel disease, or an infection such as tuberculosis as the cause of gastrointestinal symptoms. One of the conditional recommendations called for an urgent surgical consult when patients have perforation, major bleeding, or obstruction. The second conditional recommendation called for considering glucocorticoid treatment to treat an acute exacerbation of gastrointestinal involvement. Additional treatment options to pair with a glucocorticoid include a disease-modifying drug such as 5-aminosalicylic acid or azathioprine. For patients with severe or refractory gastrointestinal symptoms or both, a monoclonal TNF-alpha antagonist or thalidomide is another potential option.

The panel issued two strong recommendations for managing nervous system involvement. The top treatment option for parenchymal involvement is a high-dose glucocorticoid followed by slow tapering while also treating with an immunosuppressant such as azathioprine. Treatment with cyclosporine should be avoided, the panel said. Treatment with a monoclonal TNF-alpha antagonist is an option to consider as first-line treatment for patients with severe nervous system involvement or for those with refractory disease. The second strong recommendation was to treat a cerebral venous thrombus with a high-dose glucocorticoid followed by tapering, with short-term anticoagulant treatment as an option. Patients also need screening for the presence of vascular disease at an extracranial location.

The panel’s final recommendation was a strong endorsement of colchicine as first-line treatment for arthritis in Behçet’s patients, although patients with acute monoarticular disease can be managed with an intra-articular injection of a glucocorticoid. For patients with recurrent or chronic arthritis, treatment options include azathioprine, interferon-alpha, or a TNF-alpha antagonist.

Dr. Hatemi has received research support from, received honoraria from, or has been a speaker for AbbVie, Celgene, Merck Sharp & Dohme, and Pfizer.

[email protected]

On Twitter @mitchelzoler

LONDON – A EULAR task force issued the first update to recommendations for managing Behçet’s disease since 2008, with revised recommendations that reflect expanded use of biologic agents, and increased evidence to guide management of gastrointestinal involvement, use of anticoagulants in patients with venous involvement, and use of surgical and interventional treatments, Dr. Gülen Hatemi said while presenting the update at the European Congress of Rheumatology.

The task force, which included more than 20 members, identified 304 articles to apply to the update, and produced five overarching principal and 18 specific recommendations divided among six categories of clinical manifestations of Behçet’s disease, said Dr. Hatemi, convenor of the task force and a rheumatologist at Istanbul University.

Mitchel L. Zoler/Frontline Medical News

For mucocutaneous involvement, the update included five items that all received a “strong” recommendation from the task force: For an oral or genital ulcer, use a topical agent, such as a local steroid. Try colchicine first to prevent recurrent mucocutaneous lesions, especially when the dominant lesion is erythema nodosum or a genital ulcer. Treat papulopustular or acnelike lesions with topical or systemic agents, as when treating acne vulgaris. Coordinate treatment of leg ulcers, which can be caused by venous stasis or obliterative vasculitis, with a dermatologist and vascular surgeon. And azathioprine, thalidomide, interferon-alpha, a tumor necrosis factor (TNF)–alpha antagonist, or apremilast (Otezla) may be necessary for selected patients.

The task force issued two strong recommendations for managing eye involvement along with one conditional recommendation. The first strong recommendation was that managing uveitis requires close collaboration with an ophthalmologist, with the goal of inducing and maintaining remission. Patients with an inflammatory eye disease affecting the posterior segment should receive treatment with azathioprine, cyclosporine, interferon-alpha, or a monoclonal TNF-alpha antagonist. Treatment with a systemic corticosteroid should occur only when combined with azathioprine or another systemic immunosuppressant.

The second strong recommendation was that patients who present with an initial or recurrent acute episode of sight-threatening uveitis should receive treatment with a high-dose glucocorticoid, infliximab, or interferon-alpha. Intravitreal injection with a glucocorticoid as an adjunct to systemic therapy is an option for patients with a unilateral exacerbation. The conditional recommendation was for patients with isolated anterior uveitis. When these patients have markers of a poor prognosis – such as young age, male sex, or early disease onset – systemic treatment with an immunosuppressant is a possible option.

The panel issued three strong recommendations along with one conditional recommendation for managing vascular involvement. One of the strong recommendations called for treating acute deep vein thrombosis with a glucocorticoid as well as an immunosuppresant such as azathioprine, cyclophosphamide, or cyclosporine. A conditional recommendation said patients with refractory venous thrombosis could be considered for treatment with a monoclonal TNF-alpha antagonist, along with an anticoagulant if the patient’s risk for bleeding was generally low and a coexistent pulmonary artery aneurysm was ruled out.

Management of arterial aneurysms received the other two strong recommendations. The panel recommended high-dose glucocorticoid plus cyclophosphamide for a pulmonary artery aneurysm, followed by a monoclonal TNF-alpha antagonist for refractory cases. Patients with these aneurysms who are at high risk for major bleeding should undergo embolization in preference to open surgery. When patients have aortic or peripheral artery aneurysms, treatment should start with cyclophosphamide and a corticosteroid before an aneurysm repair is attempted. But surgery or stenting of the aneurysm should not be delayed when patients are symptomatic.

Gastrointestinal involvement received one strong and two conditional recommendations. The panel strongly recommended confirming gastrointestinal involvement using endoscopy, imaging, or both, while also ruling out treatment with a nonsteroidal anti-inflammatory drug, inflammatory bowel disease, or an infection such as tuberculosis as the cause of gastrointestinal symptoms. One of the conditional recommendations called for an urgent surgical consult when patients have perforation, major bleeding, or obstruction. The second conditional recommendation called for considering glucocorticoid treatment to treat an acute exacerbation of gastrointestinal involvement. Additional treatment options to pair with a glucocorticoid include a disease-modifying drug such as 5-aminosalicylic acid or azathioprine. For patients with severe or refractory gastrointestinal symptoms or both, a monoclonal TNF-alpha antagonist or thalidomide is another potential option.

The panel issued two strong recommendations for managing nervous system involvement. The top treatment option for parenchymal involvement is a high-dose glucocorticoid followed by slow tapering while also treating with an immunosuppressant such as azathioprine. Treatment with cyclosporine should be avoided, the panel said. Treatment with a monoclonal TNF-alpha antagonist is an option to consider as first-line treatment for patients with severe nervous system involvement or for those with refractory disease. The second strong recommendation was to treat a cerebral venous thrombus with a high-dose glucocorticoid followed by tapering, with short-term anticoagulant treatment as an option. Patients also need screening for the presence of vascular disease at an extracranial location.

The panel’s final recommendation was a strong endorsement of colchicine as first-line treatment for arthritis in Behçet’s patients, although patients with acute monoarticular disease can be managed with an intra-articular injection of a glucocorticoid. For patients with recurrent or chronic arthritis, treatment options include azathioprine, interferon-alpha, or a TNF-alpha antagonist.

Dr. Hatemi has received research support from, received honoraria from, or has been a speaker for AbbVie, Celgene, Merck Sharp & Dohme, and Pfizer.

[email protected]

On Twitter @mitchelzoler

LONDON – A EULAR task force issued the first update to recommendations for managing Behçet’s disease since 2008, with revised recommendations that reflect expanded use of biologic agents, and increased evidence to guide management of gastrointestinal involvement, use of anticoagulants in patients with venous involvement, and use of surgical and interventional treatments, Dr. Gülen Hatemi said while presenting the update at the European Congress of Rheumatology.

The task force, which included more than 20 members, identified 304 articles to apply to the update, and produced five overarching principal and 18 specific recommendations divided among six categories of clinical manifestations of Behçet’s disease, said Dr. Hatemi, convenor of the task force and a rheumatologist at Istanbul University.

Mitchel L. Zoler/Frontline Medical News

For mucocutaneous involvement, the update included five items that all received a “strong” recommendation from the task force: For an oral or genital ulcer, use a topical agent, such as a local steroid. Try colchicine first to prevent recurrent mucocutaneous lesions, especially when the dominant lesion is erythema nodosum or a genital ulcer. Treat papulopustular or acnelike lesions with topical or systemic agents, as when treating acne vulgaris. Coordinate treatment of leg ulcers, which can be caused by venous stasis or obliterative vasculitis, with a dermatologist and vascular surgeon. And azathioprine, thalidomide, interferon-alpha, a tumor necrosis factor (TNF)–alpha antagonist, or apremilast (Otezla) may be necessary for selected patients.

The task force issued two strong recommendations for managing eye involvement along with one conditional recommendation. The first strong recommendation was that managing uveitis requires close collaboration with an ophthalmologist, with the goal of inducing and maintaining remission. Patients with an inflammatory eye disease affecting the posterior segment should receive treatment with azathioprine, cyclosporine, interferon-alpha, or a monoclonal TNF-alpha antagonist. Treatment with a systemic corticosteroid should occur only when combined with azathioprine or another systemic immunosuppressant.

The second strong recommendation was that patients who present with an initial or recurrent acute episode of sight-threatening uveitis should receive treatment with a high-dose glucocorticoid, infliximab, or interferon-alpha. Intravitreal injection with a glucocorticoid as an adjunct to systemic therapy is an option for patients with a unilateral exacerbation. The conditional recommendation was for patients with isolated anterior uveitis. When these patients have markers of a poor prognosis – such as young age, male sex, or early disease onset – systemic treatment with an immunosuppressant is a possible option.

The panel issued three strong recommendations along with one conditional recommendation for managing vascular involvement. One of the strong recommendations called for treating acute deep vein thrombosis with a glucocorticoid as well as an immunosuppresant such as azathioprine, cyclophosphamide, or cyclosporine. A conditional recommendation said patients with refractory venous thrombosis could be considered for treatment with a monoclonal TNF-alpha antagonist, along with an anticoagulant if the patient’s risk for bleeding was generally low and a coexistent pulmonary artery aneurysm was ruled out.

Management of arterial aneurysms received the other two strong recommendations. The panel recommended high-dose glucocorticoid plus cyclophosphamide for a pulmonary artery aneurysm, followed by a monoclonal TNF-alpha antagonist for refractory cases. Patients with these aneurysms who are at high risk for major bleeding should undergo embolization in preference to open surgery. When patients have aortic or peripheral artery aneurysms, treatment should start with cyclophosphamide and a corticosteroid before an aneurysm repair is attempted. But surgery or stenting of the aneurysm should not be delayed when patients are symptomatic.

Gastrointestinal involvement received one strong and two conditional recommendations. The panel strongly recommended confirming gastrointestinal involvement using endoscopy, imaging, or both, while also ruling out treatment with a nonsteroidal anti-inflammatory drug, inflammatory bowel disease, or an infection such as tuberculosis as the cause of gastrointestinal symptoms. One of the conditional recommendations called for an urgent surgical consult when patients have perforation, major bleeding, or obstruction. The second conditional recommendation called for considering glucocorticoid treatment to treat an acute exacerbation of gastrointestinal involvement. Additional treatment options to pair with a glucocorticoid include a disease-modifying drug such as 5-aminosalicylic acid or azathioprine. For patients with severe or refractory gastrointestinal symptoms or both, a monoclonal TNF-alpha antagonist or thalidomide is another potential option.

The panel issued two strong recommendations for managing nervous system involvement. The top treatment option for parenchymal involvement is a high-dose glucocorticoid followed by slow tapering while also treating with an immunosuppressant such as azathioprine. Treatment with cyclosporine should be avoided, the panel said. Treatment with a monoclonal TNF-alpha antagonist is an option to consider as first-line treatment for patients with severe nervous system involvement or for those with refractory disease. The second strong recommendation was to treat a cerebral venous thrombus with a high-dose glucocorticoid followed by tapering, with short-term anticoagulant treatment as an option. Patients also need screening for the presence of vascular disease at an extracranial location.

The panel’s final recommendation was a strong endorsement of colchicine as first-line treatment for arthritis in Behçet’s patients, although patients with acute monoarticular disease can be managed with an intra-articular injection of a glucocorticoid. For patients with recurrent or chronic arthritis, treatment options include azathioprine, interferon-alpha, or a TNF-alpha antagonist.

Dr. Hatemi has received research support from, received honoraria from, or has been a speaker for AbbVie, Celgene, Merck Sharp & Dohme, and Pfizer.

[email protected]

On Twitter @mitchelzoler

Doctors who accepted a single, industry-sponsored meal worth less than $20 were significantly more likely to prescribe the featured drug to Medicare patients, based on data from a cross-sectional study of 279,669 physicians. The findings were published online June 20 in JAMA Internal Medicine (JAMA Intern. Med. 2016 Jun. doi: 10.1001/jamainternmed.2016.2765).

In a multivariate analysis, physicians who received a single meal related to the promoted drug were 1.8 times more likely to prescribe rosuvastatin than other statins, 1.7 times more likely to prescribe nebivolol than other beta-blockers, 1.5 times more likely to prescribe olmesartan than other ACE inhibitors or ARBs, and more than twice as likely to prescribe desvenlafaxine than other SSRIs and serotonin norepinephrine reuptake inhibitors (odds ratio, 2.18).

gerenme/ThinkStock

These differences remained significant after controlling for factors including prescribing volume, physician specialty, practice setting, and demographics. Prescribing rates increased with additional meals and more expensive meals.

Previous studies have identified associations between increased prescribing and industry payments to physicians, wrote Colette DeJong, a research fellow at the University of California, San Francisco, Center for Healthcare Value, and her colleagues. However, “It is not known whether much smaller payments, such as sponsored meals, are associated with increased prescribing of the promoted brand-name drug over therapeutic alternatives,” they noted.

The researchers reviewed data from the federal Open Payments program from Aug. 1 through Dec. 31, 2013, as well as Medicare Part D prescribing data for 2013.

The results were limited by the cross-sectional nature of the study and the limitations of data from the Open Payments program, and the data reflect an association, not a cause-and-effect relationship, the researchers noted. However, “Our results are consistent with recent analyses that linked federal or state-level physician payment records with Medicare Part D prescribing data,” and with smaller studies, they said. “Future research could compare industry-sponsored meals and other methods for disseminating drug information, such as academic detailing and independent drug bulletins, with respect to the cost and quality of prescribing,” they added. The researchers had no financial conflicts to disclose.

Read the full study here: http://archinte.jamanetwork.com/article.aspx?doi=10.1001/jamainternmed.2016.2765.

Doctors who accepted a single, industry-sponsored meal worth less than $20 were significantly more likely to prescribe the featured drug to Medicare patients, based on data from a cross-sectional study of 279,669 physicians. The findings were published online June 20 in JAMA Internal Medicine (JAMA Intern. Med. 2016 Jun. doi: 10.1001/jamainternmed.2016.2765).

In a multivariate analysis, physicians who received a single meal related to the promoted drug were 1.8 times more likely to prescribe rosuvastatin than other statins, 1.7 times more likely to prescribe nebivolol than other beta-blockers, 1.5 times more likely to prescribe olmesartan than other ACE inhibitors or ARBs, and more than twice as likely to prescribe desvenlafaxine than other SSRIs and serotonin norepinephrine reuptake inhibitors (odds ratio, 2.18).

gerenme/ThinkStock

These differences remained significant after controlling for factors including prescribing volume, physician specialty, practice setting, and demographics. Prescribing rates increased with additional meals and more expensive meals.

Previous studies have identified associations between increased prescribing and industry payments to physicians, wrote Colette DeJong, a research fellow at the University of California, San Francisco, Center for Healthcare Value, and her colleagues. However, “It is not known whether much smaller payments, such as sponsored meals, are associated with increased prescribing of the promoted brand-name drug over therapeutic alternatives,” they noted.

The researchers reviewed data from the federal Open Payments program from Aug. 1 through Dec. 31, 2013, as well as Medicare Part D prescribing data for 2013.

The results were limited by the cross-sectional nature of the study and the limitations of data from the Open Payments program, and the data reflect an association, not a cause-and-effect relationship, the researchers noted. However, “Our results are consistent with recent analyses that linked federal or state-level physician payment records with Medicare Part D prescribing data,” and with smaller studies, they said. “Future research could compare industry-sponsored meals and other methods for disseminating drug information, such as academic detailing and independent drug bulletins, with respect to the cost and quality of prescribing,” they added. The researchers had no financial conflicts to disclose.

Read the full study here: http://archinte.jamanetwork.com/article.aspx?doi=10.1001/jamainternmed.2016.2765.

Doctors who accepted a single, industry-sponsored meal worth less than $20 were significantly more likely to prescribe the featured drug to Medicare patients, based on data from a cross-sectional study of 279,669 physicians. The findings were published online June 20 in JAMA Internal Medicine (JAMA Intern. Med. 2016 Jun. doi: 10.1001/jamainternmed.2016.2765).

In a multivariate analysis, physicians who received a single meal related to the promoted drug were 1.8 times more likely to prescribe rosuvastatin than other statins, 1.7 times more likely to prescribe nebivolol than other beta-blockers, 1.5 times more likely to prescribe olmesartan than other ACE inhibitors or ARBs, and more than twice as likely to prescribe desvenlafaxine than other SSRIs and serotonin norepinephrine reuptake inhibitors (odds ratio, 2.18).

gerenme/ThinkStock

These differences remained significant after controlling for factors including prescribing volume, physician specialty, practice setting, and demographics. Prescribing rates increased with additional meals and more expensive meals.

Previous studies have identified associations between increased prescribing and industry payments to physicians, wrote Colette DeJong, a research fellow at the University of California, San Francisco, Center for Healthcare Value, and her colleagues. However, “It is not known whether much smaller payments, such as sponsored meals, are associated with increased prescribing of the promoted brand-name drug over therapeutic alternatives,” they noted.

The researchers reviewed data from the federal Open Payments program from Aug. 1 through Dec. 31, 2013, as well as Medicare Part D prescribing data for 2013.

The results were limited by the cross-sectional nature of the study and the limitations of data from the Open Payments program, and the data reflect an association, not a cause-and-effect relationship, the researchers noted. However, “Our results are consistent with recent analyses that linked federal or state-level physician payment records with Medicare Part D prescribing data,” and with smaller studies, they said. “Future research could compare industry-sponsored meals and other methods for disseminating drug information, such as academic detailing and independent drug bulletins, with respect to the cost and quality of prescribing,” they added. The researchers had no financial conflicts to disclose.

Read the full study here: http://archinte.jamanetwork.com/article.aspx?doi=10.1001/jamainternmed.2016.2765.

Researchers have identified a “sweet spot” target for reducing low-density lipoprotein cholesterol levels with statin therapy that is associated with the lowest risk of adverse cardiac outcomes.

A study published online June 20 in JAMA Internal Medicine analyzed data from an Israeli health care organization between 2009-2013 and identified 31,619 patients with ischemic heart disease, aged 30-84 years, who were being treated with statins and were at least 80% adherent to the medication regime.

Louise Koenig/Frontline Medical News

The analysis showed individuals who achieved a “moderate” LDL-C level – between 70.1-100.0 mg/dL – after 1 year of statin treatment had an 11% lower incidence of major adverse cardiac events, compared with those with a “high” LDL-C level – between 100.1-130.0 mg/dL (95% confidence interval, 0.84-0.94; P less than .001).

However researchers observed no significant difference in the risk of adverse cardiac events between the moderate group and those who achieved a “low” LDL-C equal to or less than 70.0mg/dL (hazard ratio, 1.02; 95% CI, 0.97-1.07; P = .54).

In a further analysis that included 54,884 individuals who were at least 50% adherent to their statin therapy, there was a slightly increased risk of major cardiac events in patients who achieved a low LDL-C, compared with those in the moderate LDL-C group, and a significant 13% reduction in risk in the moderate LDL-C group, compared with the high LDL-C group.

“Whereas this may reflect clinical risk of low levels of LDL-C, these results further support the main findings of this study that achieving a level below 70 mg/dL is not beneficial for all patients,” wrote Dr. Morton Leibowitz, from the Clalit Research Institute, Tel Aviv, and his coauthors.

Adjustment for age did not significantly alter the interaction between LDL-C levels and the risk of adverse cardiac events (JAMA Intern Med. 2016 Jun 20. doi: 10.1001/jamainternmed.2016.2751).

“The question of the association between achieved LDL-C levels and major adverse cardiac events for secondary prevention has become highly relevant, particularly in the real-world context of patients excluded from [randomized, controlled trials],” the authors wrote, suggesting that their data only partially support recent claims that lower LDL-C is better for cardiac outcomes.

“Our findings of significantly lower risk of MACEs associated with achieved LDL-C level of less than 100.0 mg/dL but not with achieved LDL-C of less than 70.0 mg/dL suggest a target for long-term statin treatment.”

The study was funded by the Clalit Research Institute. No conflicts of interest were reported.

Researchers have identified a “sweet spot” target for reducing low-density lipoprotein cholesterol levels with statin therapy that is associated with the lowest risk of adverse cardiac outcomes.

A study published online June 20 in JAMA Internal Medicine analyzed data from an Israeli health care organization between 2009-2013 and identified 31,619 patients with ischemic heart disease, aged 30-84 years, who were being treated with statins and were at least 80% adherent to the medication regime.

Louise Koenig/Frontline Medical News

The analysis showed individuals who achieved a “moderate” LDL-C level – between 70.1-100.0 mg/dL – after 1 year of statin treatment had an 11% lower incidence of major adverse cardiac events, compared with those with a “high” LDL-C level – between 100.1-130.0 mg/dL (95% confidence interval, 0.84-0.94; P less than .001).

However researchers observed no significant difference in the risk of adverse cardiac events between the moderate group and those who achieved a “low” LDL-C equal to or less than 70.0mg/dL (hazard ratio, 1.02; 95% CI, 0.97-1.07; P = .54).

In a further analysis that included 54,884 individuals who were at least 50% adherent to their statin therapy, there was a slightly increased risk of major cardiac events in patients who achieved a low LDL-C, compared with those in the moderate LDL-C group, and a significant 13% reduction in risk in the moderate LDL-C group, compared with the high LDL-C group.

“Whereas this may reflect clinical risk of low levels of LDL-C, these results further support the main findings of this study that achieving a level below 70 mg/dL is not beneficial for all patients,” wrote Dr. Morton Leibowitz, from the Clalit Research Institute, Tel Aviv, and his coauthors.

Adjustment for age did not significantly alter the interaction between LDL-C levels and the risk of adverse cardiac events (JAMA Intern Med. 2016 Jun 20. doi: 10.1001/jamainternmed.2016.2751).

“The question of the association between achieved LDL-C levels and major adverse cardiac events for secondary prevention has become highly relevant, particularly in the real-world context of patients excluded from [randomized, controlled trials],” the authors wrote, suggesting that their data only partially support recent claims that lower LDL-C is better for cardiac outcomes.

“Our findings of significantly lower risk of MACEs associated with achieved LDL-C level of less than 100.0 mg/dL but not with achieved LDL-C of less than 70.0 mg/dL suggest a target for long-term statin treatment.”

The study was funded by the Clalit Research Institute. No conflicts of interest were reported.

Researchers have identified a “sweet spot” target for reducing low-density lipoprotein cholesterol levels with statin therapy that is associated with the lowest risk of adverse cardiac outcomes.

A study published online June 20 in JAMA Internal Medicine analyzed data from an Israeli health care organization between 2009-2013 and identified 31,619 patients with ischemic heart disease, aged 30-84 years, who were being treated with statins and were at least 80% adherent to the medication regime.

Louise Koenig/Frontline Medical News

The analysis showed individuals who achieved a “moderate” LDL-C level – between 70.1-100.0 mg/dL – after 1 year of statin treatment had an 11% lower incidence of major adverse cardiac events, compared with those with a “high” LDL-C level – between 100.1-130.0 mg/dL (95% confidence interval, 0.84-0.94; P less than .001).

However researchers observed no significant difference in the risk of adverse cardiac events between the moderate group and those who achieved a “low” LDL-C equal to or less than 70.0mg/dL (hazard ratio, 1.02; 95% CI, 0.97-1.07; P = .54).

In a further analysis that included 54,884 individuals who were at least 50% adherent to their statin therapy, there was a slightly increased risk of major cardiac events in patients who achieved a low LDL-C, compared with those in the moderate LDL-C group, and a significant 13% reduction in risk in the moderate LDL-C group, compared with the high LDL-C group.

“Whereas this may reflect clinical risk of low levels of LDL-C, these results further support the main findings of this study that achieving a level below 70 mg/dL is not beneficial for all patients,” wrote Dr. Morton Leibowitz, from the Clalit Research Institute, Tel Aviv, and his coauthors.

Adjustment for age did not significantly alter the interaction between LDL-C levels and the risk of adverse cardiac events (JAMA Intern Med. 2016 Jun 20. doi: 10.1001/jamainternmed.2016.2751).

“The question of the association between achieved LDL-C levels and major adverse cardiac events for secondary prevention has become highly relevant, particularly in the real-world context of patients excluded from [randomized, controlled trials],” the authors wrote, suggesting that their data only partially support recent claims that lower LDL-C is better for cardiac outcomes.

“Our findings of significantly lower risk of MACEs associated with achieved LDL-C level of less than 100.0 mg/dL but not with achieved LDL-C of less than 70.0 mg/dL suggest a target for long-term statin treatment.”

The study was funded by the Clalit Research Institute. No conflicts of interest were reported.

Check out the June issue of Vascular Specialist now online in our enhanced digital edition and standard PDF. This month includes stories on vascular trainee case loads, the difficulties surgeons have at estimating blood loss, and an editorial by Dr. Russell Samson asking “Why be a vascular surgeon?”

Our Point/Counterpoint features a debate on the importance of the angiosome concept in revascularization for limb salvage between Dr. Richard Neville and Dr. Bauer Sumpio, and our Medicolegal Issues column examines the liability issues raised by the new move to value-based care.

Check out the June issue of Vascular Specialist now online in our enhanced digital edition and standard PDF. This month includes stories on vascular trainee case loads, the difficulties surgeons have at estimating blood loss, and an editorial by Dr. Russell Samson asking “Why be a vascular surgeon?”

Our Point/Counterpoint features a debate on the importance of the angiosome concept in revascularization for limb salvage between Dr. Richard Neville and Dr. Bauer Sumpio, and our Medicolegal Issues column examines the liability issues raised by the new move to value-based care.

Check out the June issue of Vascular Specialist now online in our enhanced digital edition and standard PDF. This month includes stories on vascular trainee case loads, the difficulties surgeons have at estimating blood loss, and an editorial by Dr. Russell Samson asking “Why be a vascular surgeon?”

Our Point/Counterpoint features a debate on the importance of the angiosome concept in revascularization for limb salvage between Dr. Richard Neville and Dr. Bauer Sumpio, and our Medicolegal Issues column examines the liability issues raised by the new move to value-based care.