The majority of physician practices are uncertain about joining or starting an accountable care organization (ACO), according to a survey.

Of nearly 400 hospital-owned and freestanding outpatient practices, 65% were unsure how to approach accountable care, a survey by Healthcare Information and Management Systems Society (HIMSS) Analytics found. About 13% of health providers said they expected to join an established ACO, while 14% planned to form an ACO, and 8% planned to create an ACO with a neighboring provider.

HIMSS Analytics director of research Brendan FitzGeraldand his team surveyed 436 health providers during June 23–July 12, 2016, regarding electronic health record (EHR) adoption, accountable care, and health information exchanges, among other subjects. The respondents included physicians, practice managers/administrators, physician assistants, nurse practitioners, and practice IT directors. Investigators also analyzed the HIMSS Analytics LOGIC database, which includes 47,084 hospital-owned practices and 57,909 freestanding practices.

Respondents also reported a high level of uncertainty around plans to join a health information exchange (HIE): 48% of health providers were unsure about whether to join an HIE, compared with 46% who were uncertain in 2015. Of respondents who plan to join an HIE, 10% plan to enter a hospital or health system HIE, 7% plan to enter a regional HIE, and 17% plan to join a state health information exchange.

As far as EHR adoption, nearly 78% of respondents representing a free standing outpatient facility (228 practices) reported having an EHR, a 30% increase since 2010. Data from the LOGIC database found 92% of hospital-owned outpatient facilities had a live and operational EHR. Of all survey respondents, 66% did not have plans to replace or upgrade their current outpatient solution, or purchase a new solution. Of health providers that planned to purchase a new EHR, 18% said they would be upgrading, 9% would be purchasing a new solution, and 7% would be replacing a their current EHR.

The survey shows that most doctors appear to be content with the EHR solutions they have adopted with no plans to change systems, said Mr. FitzGerald.

“The level of universal adoption is great, and it seems that physicians for the most part, are satisfied with the work they’ve done to implement and utilize these solutions the first time around,” he said in an interview. “While there may be some getting used to the process of using these particular solutions or even some functionality shortcomings, it seems likes physicians are moving forward with the solutions they have on hand.”

[email protected]

On Twitter @legal_med

The majority of physician practices are uncertain about joining or starting an accountable care organization (ACO), according to a survey.

Of nearly 400 hospital-owned and freestanding outpatient practices, 65% were unsure how to approach accountable care, a survey by Healthcare Information and Management Systems Society (HIMSS) Analytics found. About 13% of health providers said they expected to join an established ACO, while 14% planned to form an ACO, and 8% planned to create an ACO with a neighboring provider.

HIMSS Analytics director of research Brendan FitzGeraldand his team surveyed 436 health providers during June 23–July 12, 2016, regarding electronic health record (EHR) adoption, accountable care, and health information exchanges, among other subjects. The respondents included physicians, practice managers/administrators, physician assistants, nurse practitioners, and practice IT directors. Investigators also analyzed the HIMSS Analytics LOGIC database, which includes 47,084 hospital-owned practices and 57,909 freestanding practices.

Respondents also reported a high level of uncertainty around plans to join a health information exchange (HIE): 48% of health providers were unsure about whether to join an HIE, compared with 46% who were uncertain in 2015. Of respondents who plan to join an HIE, 10% plan to enter a hospital or health system HIE, 7% plan to enter a regional HIE, and 17% plan to join a state health information exchange.

As far as EHR adoption, nearly 78% of respondents representing a free standing outpatient facility (228 practices) reported having an EHR, a 30% increase since 2010. Data from the LOGIC database found 92% of hospital-owned outpatient facilities had a live and operational EHR. Of all survey respondents, 66% did not have plans to replace or upgrade their current outpatient solution, or purchase a new solution. Of health providers that planned to purchase a new EHR, 18% said they would be upgrading, 9% would be purchasing a new solution, and 7% would be replacing a their current EHR.

The survey shows that most doctors appear to be content with the EHR solutions they have adopted with no plans to change systems, said Mr. FitzGerald.

“The level of universal adoption is great, and it seems that physicians for the most part, are satisfied with the work they’ve done to implement and utilize these solutions the first time around,” he said in an interview. “While there may be some getting used to the process of using these particular solutions or even some functionality shortcomings, it seems likes physicians are moving forward with the solutions they have on hand.”

[email protected]

On Twitter @legal_med

The majority of physician practices are uncertain about joining or starting an accountable care organization (ACO), according to a survey.

Of nearly 400 hospital-owned and freestanding outpatient practices, 65% were unsure how to approach accountable care, a survey by Healthcare Information and Management Systems Society (HIMSS) Analytics found. About 13% of health providers said they expected to join an established ACO, while 14% planned to form an ACO, and 8% planned to create an ACO with a neighboring provider.

HIMSS Analytics director of research Brendan FitzGeraldand his team surveyed 436 health providers during June 23–July 12, 2016, regarding electronic health record (EHR) adoption, accountable care, and health information exchanges, among other subjects. The respondents included physicians, practice managers/administrators, physician assistants, nurse practitioners, and practice IT directors. Investigators also analyzed the HIMSS Analytics LOGIC database, which includes 47,084 hospital-owned practices and 57,909 freestanding practices.

Respondents also reported a high level of uncertainty around plans to join a health information exchange (HIE): 48% of health providers were unsure about whether to join an HIE, compared with 46% who were uncertain in 2015. Of respondents who plan to join an HIE, 10% plan to enter a hospital or health system HIE, 7% plan to enter a regional HIE, and 17% plan to join a state health information exchange.

As far as EHR adoption, nearly 78% of respondents representing a free standing outpatient facility (228 practices) reported having an EHR, a 30% increase since 2010. Data from the LOGIC database found 92% of hospital-owned outpatient facilities had a live and operational EHR. Of all survey respondents, 66% did not have plans to replace or upgrade their current outpatient solution, or purchase a new solution. Of health providers that planned to purchase a new EHR, 18% said they would be upgrading, 9% would be purchasing a new solution, and 7% would be replacing a their current EHR.

The survey shows that most doctors appear to be content with the EHR solutions they have adopted with no plans to change systems, said Mr. FitzGerald.

“The level of universal adoption is great, and it seems that physicians for the most part, are satisfied with the work they’ve done to implement and utilize these solutions the first time around,” he said in an interview. “While there may be some getting used to the process of using these particular solutions or even some functionality shortcomings, it seems likes physicians are moving forward with the solutions they have on hand.”

[email protected]

On Twitter @legal_med

DENVER – MRI of the sacroiliac joint now serves as the primary imaging driver for a diagnosis of spondyloarthritis, especially early spondyloarthritis, and has largely supplanted radiographic assessment, Walter P. Maksymowych, MD, said at an educational symposium organized by the Spondyloarthritis Research and Treatment Network.

“MRI is reliable for early diagnosis; radiographic assessment of early spondyloarthritis is problematic,” said Dr. Maksymowych, a rheumatologist and professor of medicine at the University of Alberta in Edmonton. “The EULAR recommendations now say that early diagnosis of spondyloarthritis needs to focus on MRI.”

Mitchel L. Zoler/Frontline Medical News

While the recommendations from the European League Against Rheumatism (EULAR) that came out last year on using imaging for diagnosing and managing spondyloarthritis (SpA) cite radiography of the patient’s sacroiliac joint as the recommended first imaging method to use to diagnose sacroiliitis as part of a diagnosis of axial SpA, the EULAR recommendations place MRI very close behind.

The recommendations list MRI as an “alternative” first-line approach for diagnostic imaging. For patients who appear negative for axial SpA on radiographic imaging but who remain suspected of having SpA the EULAR panel “recommended” MRI of the sacroiliac joints as a backup method for imaging assessment and to definitively rule out SpA. No other imaging method received EULAR’s endorsement for SpA diagnosis aside from these two approaches.

The recommendations direct the MRI examination to include assessment of inflammation based on bone marrow edema, and also structural abnormalities including bone erosion, new bone formation, sclerosis and fat infiltration. The 2015 EULAR recommendations also cite roles for MRI in diagnosing peripheral SpA, monitoring disease activity in axial and peripheral SpA, monioring structural changes in axial and peripheral SpA, predicting outcome and treatment effect in axial SpA, assessing spinal fracture in patients with axial SpA and to assess osteoporosis in selected axial SpA patients.

The MRI imaging sequences particularly useful for SpA diagnosis are “short tau inversion recovery” (STIR), a “water sensitive” sequence that involves suppression of the fat MRI signal, and a T1 weighted sequence that is a “fat sensitive” scan, explained Dr. Maksymowych at the symposium, also organized by the Group for the Research and Assessment of Psoriasis and Psoriatic Arthritis (GRAPPA). He strongly encouraged clinicians to apply a standardized approach to imaging in every patient suspected of having axial SpA.

The definition of an MRI imaging result that is positive for SpA remains a consensus of expert opinion without a firm evidence base. The currently accepted MRI marker of SpA involves identifying several areas of bone marrow edema in a single T1 and STIR MRI image-slice through the sacroiliac joint, or focal bone marrow edema visible in at least two consecutive sacroiliac joint T1 and STIR image slices.

The confluence of a structural lesion at the same site as bone marrow edema provides further confirmatory information, he said. “A structural lesions at the site of bone marrow edema enhances your confidence in the diagnosis,” he said.

“The specificity of MRI for SpA is quite high,” Dr. Maksymowych noted, with specificity rates often in the range of 85%-95%. Sensitivity rates are lower, often 50%-70%. Sensitivity further improves by factoring in the presence of bone erosions. Diagnostic confidence also increases as the number of lesions visualized increases.

MRI has become so integral to the assessment of SpA that “to understand SpA you need to understand the language of MRI,” Dr. Maksymowych concluded.

Dr. Maksymowych has received honoraria from eight drug companies and research grant support from Abbvie and Pfizer.

[email protected]

On Twitter @mitchelzoler

DENVER – MRI of the sacroiliac joint now serves as the primary imaging driver for a diagnosis of spondyloarthritis, especially early spondyloarthritis, and has largely supplanted radiographic assessment, Walter P. Maksymowych, MD, said at an educational symposium organized by the Spondyloarthritis Research and Treatment Network.

“MRI is reliable for early diagnosis; radiographic assessment of early spondyloarthritis is problematic,” said Dr. Maksymowych, a rheumatologist and professor of medicine at the University of Alberta in Edmonton. “The EULAR recommendations now say that early diagnosis of spondyloarthritis needs to focus on MRI.”

Mitchel L. Zoler/Frontline Medical News

While the recommendations from the European League Against Rheumatism (EULAR) that came out last year on using imaging for diagnosing and managing spondyloarthritis (SpA) cite radiography of the patient’s sacroiliac joint as the recommended first imaging method to use to diagnose sacroiliitis as part of a diagnosis of axial SpA, the EULAR recommendations place MRI very close behind.

The recommendations list MRI as an “alternative” first-line approach for diagnostic imaging. For patients who appear negative for axial SpA on radiographic imaging but who remain suspected of having SpA the EULAR panel “recommended” MRI of the sacroiliac joints as a backup method for imaging assessment and to definitively rule out SpA. No other imaging method received EULAR’s endorsement for SpA diagnosis aside from these two approaches.

The recommendations direct the MRI examination to include assessment of inflammation based on bone marrow edema, and also structural abnormalities including bone erosion, new bone formation, sclerosis and fat infiltration. The 2015 EULAR recommendations also cite roles for MRI in diagnosing peripheral SpA, monitoring disease activity in axial and peripheral SpA, monioring structural changes in axial and peripheral SpA, predicting outcome and treatment effect in axial SpA, assessing spinal fracture in patients with axial SpA and to assess osteoporosis in selected axial SpA patients.

The MRI imaging sequences particularly useful for SpA diagnosis are “short tau inversion recovery” (STIR), a “water sensitive” sequence that involves suppression of the fat MRI signal, and a T1 weighted sequence that is a “fat sensitive” scan, explained Dr. Maksymowych at the symposium, also organized by the Group for the Research and Assessment of Psoriasis and Psoriatic Arthritis (GRAPPA). He strongly encouraged clinicians to apply a standardized approach to imaging in every patient suspected of having axial SpA.

The definition of an MRI imaging result that is positive for SpA remains a consensus of expert opinion without a firm evidence base. The currently accepted MRI marker of SpA involves identifying several areas of bone marrow edema in a single T1 and STIR MRI image-slice through the sacroiliac joint, or focal bone marrow edema visible in at least two consecutive sacroiliac joint T1 and STIR image slices.

The confluence of a structural lesion at the same site as bone marrow edema provides further confirmatory information, he said. “A structural lesions at the site of bone marrow edema enhances your confidence in the diagnosis,” he said.

“The specificity of MRI for SpA is quite high,” Dr. Maksymowych noted, with specificity rates often in the range of 85%-95%. Sensitivity rates are lower, often 50%-70%. Sensitivity further improves by factoring in the presence of bone erosions. Diagnostic confidence also increases as the number of lesions visualized increases.

MRI has become so integral to the assessment of SpA that “to understand SpA you need to understand the language of MRI,” Dr. Maksymowych concluded.

Dr. Maksymowych has received honoraria from eight drug companies and research grant support from Abbvie and Pfizer.

[email protected]

On Twitter @mitchelzoler

DENVER – MRI of the sacroiliac joint now serves as the primary imaging driver for a diagnosis of spondyloarthritis, especially early spondyloarthritis, and has largely supplanted radiographic assessment, Walter P. Maksymowych, MD, said at an educational symposium organized by the Spondyloarthritis Research and Treatment Network.

“MRI is reliable for early diagnosis; radiographic assessment of early spondyloarthritis is problematic,” said Dr. Maksymowych, a rheumatologist and professor of medicine at the University of Alberta in Edmonton. “The EULAR recommendations now say that early diagnosis of spondyloarthritis needs to focus on MRI.”

Mitchel L. Zoler/Frontline Medical News

While the recommendations from the European League Against Rheumatism (EULAR) that came out last year on using imaging for diagnosing and managing spondyloarthritis (SpA) cite radiography of the patient’s sacroiliac joint as the recommended first imaging method to use to diagnose sacroiliitis as part of a diagnosis of axial SpA, the EULAR recommendations place MRI very close behind.

The recommendations list MRI as an “alternative” first-line approach for diagnostic imaging. For patients who appear negative for axial SpA on radiographic imaging but who remain suspected of having SpA the EULAR panel “recommended” MRI of the sacroiliac joints as a backup method for imaging assessment and to definitively rule out SpA. No other imaging method received EULAR’s endorsement for SpA diagnosis aside from these two approaches.

The recommendations direct the MRI examination to include assessment of inflammation based on bone marrow edema, and also structural abnormalities including bone erosion, new bone formation, sclerosis and fat infiltration. The 2015 EULAR recommendations also cite roles for MRI in diagnosing peripheral SpA, monitoring disease activity in axial and peripheral SpA, monioring structural changes in axial and peripheral SpA, predicting outcome and treatment effect in axial SpA, assessing spinal fracture in patients with axial SpA and to assess osteoporosis in selected axial SpA patients.

The MRI imaging sequences particularly useful for SpA diagnosis are “short tau inversion recovery” (STIR), a “water sensitive” sequence that involves suppression of the fat MRI signal, and a T1 weighted sequence that is a “fat sensitive” scan, explained Dr. Maksymowych at the symposium, also organized by the Group for the Research and Assessment of Psoriasis and Psoriatic Arthritis (GRAPPA). He strongly encouraged clinicians to apply a standardized approach to imaging in every patient suspected of having axial SpA.

The definition of an MRI imaging result that is positive for SpA remains a consensus of expert opinion without a firm evidence base. The currently accepted MRI marker of SpA involves identifying several areas of bone marrow edema in a single T1 and STIR MRI image-slice through the sacroiliac joint, or focal bone marrow edema visible in at least two consecutive sacroiliac joint T1 and STIR image slices.

The confluence of a structural lesion at the same site as bone marrow edema provides further confirmatory information, he said. “A structural lesions at the site of bone marrow edema enhances your confidence in the diagnosis,” he said.

“The specificity of MRI for SpA is quite high,” Dr. Maksymowych noted, with specificity rates often in the range of 85%-95%. Sensitivity rates are lower, often 50%-70%. Sensitivity further improves by factoring in the presence of bone erosions. Diagnostic confidence also increases as the number of lesions visualized increases.

MRI has become so integral to the assessment of SpA that “to understand SpA you need to understand the language of MRI,” Dr. Maksymowych concluded.

Dr. Maksymowych has received honoraria from eight drug companies and research grant support from Abbvie and Pfizer.

[email protected]

On Twitter @mitchelzoler

Ticagrelor tablets

Photo from AstraZeneca

The National Institute for Health and Care Excellence (NICE) has published a draft guidance recommending the antiplatelet agent ticagrelor (Brilique, AstraZeneca) be made available on the National Health Service (NHS) at a lower dose that can be used for a longer duration.

NICE previously decided ticagrelor should be available on the NHS as a treatment option for certain patients with acute coronary syndromes.

For these patients, the drug could be given at a dose of 90 mg, in combination with low-dose aspirin, for up to a year to prevent atherothrombotic events.

Now, NICE is recommending an additional option.

The agency’s new draft guidance recommends ticagrelor at 60 mg, to be given twice a day in combination with aspirin at 75 mg to 150 mg daily, as a continuation therapy for the prevention of atherothrombotic events in certain patients with a history of myocardial infarction and a high risk of developing atherothrombotic events.

Patients must have had a myocardial infarction at least a year ago and have already taken ticagrelor at 90 mg (or another adenosine diphosphate receptor inhibitor therapy), in combination with aspirin, for 1 year.

Ticagrelor at 60 mg, plus aspirin, must be continued without interruption. And the treatment must be stopped when clinically indicated or after a maximum of 3 years.

“The evidence shows that ticagrelor, in combination with aspirin, is effective at reducing the risk of further heart attacks and strokes in people who have already had a heart attack,” said Carole Longson, director of the Centre for Health Technology Evaluation at NICE.

“In provisionally recommending ticagrelor, we are pleased to be able to increase the treatment options available to the many thousands of people who stand to benefit from it.”

NICE’s new draft guidance is not intended to affect the position of patients whose treatment with ticagrelor at 60 mg, in combination with aspirin, as a continuation therapy was started within the NHS before this guidance was published.

Treatment of those patients may continue without change to whatever funding arrangements were in place for them before this guidance was published until they and their NHS clinician consider it appropriate to stop.

NICE’s draft guidance is open for comments until 5 pm (GMT) on September 5, 2016.

Ticagrelor tablets

Photo from AstraZeneca

The National Institute for Health and Care Excellence (NICE) has published a draft guidance recommending the antiplatelet agent ticagrelor (Brilique, AstraZeneca) be made available on the National Health Service (NHS) at a lower dose that can be used for a longer duration.

NICE previously decided ticagrelor should be available on the NHS as a treatment option for certain patients with acute coronary syndromes.

For these patients, the drug could be given at a dose of 90 mg, in combination with low-dose aspirin, for up to a year to prevent atherothrombotic events.

Now, NICE is recommending an additional option.

The agency’s new draft guidance recommends ticagrelor at 60 mg, to be given twice a day in combination with aspirin at 75 mg to 150 mg daily, as a continuation therapy for the prevention of atherothrombotic events in certain patients with a history of myocardial infarction and a high risk of developing atherothrombotic events.

Patients must have had a myocardial infarction at least a year ago and have already taken ticagrelor at 90 mg (or another adenosine diphosphate receptor inhibitor therapy), in combination with aspirin, for 1 year.

Ticagrelor at 60 mg, plus aspirin, must be continued without interruption. And the treatment must be stopped when clinically indicated or after a maximum of 3 years.

“The evidence shows that ticagrelor, in combination with aspirin, is effective at reducing the risk of further heart attacks and strokes in people who have already had a heart attack,” said Carole Longson, director of the Centre for Health Technology Evaluation at NICE.

“In provisionally recommending ticagrelor, we are pleased to be able to increase the treatment options available to the many thousands of people who stand to benefit from it.”

NICE’s new draft guidance is not intended to affect the position of patients whose treatment with ticagrelor at 60 mg, in combination with aspirin, as a continuation therapy was started within the NHS before this guidance was published.

Treatment of those patients may continue without change to whatever funding arrangements were in place for them before this guidance was published until they and their NHS clinician consider it appropriate to stop.

NICE’s draft guidance is open for comments until 5 pm (GMT) on September 5, 2016.

Ticagrelor tablets

Photo from AstraZeneca

The National Institute for Health and Care Excellence (NICE) has published a draft guidance recommending the antiplatelet agent ticagrelor (Brilique, AstraZeneca) be made available on the National Health Service (NHS) at a lower dose that can be used for a longer duration.

NICE previously decided ticagrelor should be available on the NHS as a treatment option for certain patients with acute coronary syndromes.

For these patients, the drug could be given at a dose of 90 mg, in combination with low-dose aspirin, for up to a year to prevent atherothrombotic events.

Now, NICE is recommending an additional option.

The agency’s new draft guidance recommends ticagrelor at 60 mg, to be given twice a day in combination with aspirin at 75 mg to 150 mg daily, as a continuation therapy for the prevention of atherothrombotic events in certain patients with a history of myocardial infarction and a high risk of developing atherothrombotic events.

Patients must have had a myocardial infarction at least a year ago and have already taken ticagrelor at 90 mg (or another adenosine diphosphate receptor inhibitor therapy), in combination with aspirin, for 1 year.

Ticagrelor at 60 mg, plus aspirin, must be continued without interruption. And the treatment must be stopped when clinically indicated or after a maximum of 3 years.

“The evidence shows that ticagrelor, in combination with aspirin, is effective at reducing the risk of further heart attacks and strokes in people who have already had a heart attack,” said Carole Longson, director of the Centre for Health Technology Evaluation at NICE.

“In provisionally recommending ticagrelor, we are pleased to be able to increase the treatment options available to the many thousands of people who stand to benefit from it.”

NICE’s new draft guidance is not intended to affect the position of patients whose treatment with ticagrelor at 60 mg, in combination with aspirin, as a continuation therapy was started within the NHS before this guidance was published.

Treatment of those patients may continue without change to whatever funding arrangements were in place for them before this guidance was published until they and their NHS clinician consider it appropriate to stop.

NICE’s draft guidance is open for comments until 5 pm (GMT) on September 5, 2016.

DENVER – During early 2015, exactly a quarter of all patients seen in U.S. rheumatology practices were diagnosed with rheumatoid arthritis, and among them two-thirds received treatment with a disease modifying nonbiologic drug, based on data from more than 200,000 patients who enrolled in an American College of Rheumatology registry during that time.

That’s an example of some of the data now available in an EHR-based registry run by the ACR and open to participation by any U.S.-based rheumatologist, Kaleb Michaud, PhD, said at the annual meeting of the Spondyloarthritis Research and Treatment Network.

Mitchel L. Zoler/Frontline Medical News

The ACR’s Rheumatology Informatics System for Effectiveness (RISE) is an EHR-based registry of passive reporting that as of July 2016 had enrolled 614,738 U.S. patients treated by 1,284 providers in 213 practices, said Dr. Michaud, codirector of the National Data Bank for Rheumatic Diseases in Wichita, Kan., who works with the ACR on RISE as a volunteer.

Patient participation in RISE more than doubled during the past year, rising from 302,000 participating patients in September 2015. In addition to enrolling even more providers with more patients to participate, RISE’s organizers is also now seeking investigators who can use the data collected in RISE to address useful research questions, he said.

RISE has been designated a qualified clinical data registry (QCDR) by the Centers for Medicare & Medicaid Services. If providers using RISE sign an agreement stating that they want to participate for quality reporting purposes, it then happens automatically. Participating practices also meet Medicare’s meaningful use measure of reporting to a specialty registry. Although most rheumatologists with academic positions already have these opportunities, for community rheumatologists this access is “a perq,” Dr. Michaud said.

As just an example of the data trove accumulating in RISE, Dr, Michaud rattled off some quick figures culled from analysis of the 239,302 RISE patients in 55 U.S. practices who entered the registry during October 2014-September 2015. The patients averaged 59 years of age, three quarters were women, 61% were white, 48% had commercial insurance and 30% were covered through Medicare.

Their most recent diagnosis was rheumatoid arthritis in 25%, unspecified myalgia or myositis in 21%, Sjögren’s syndrome in 7%, systemic lupus erythematosus in 6%, psoriatic arthritis in 6%, spondyloarthritides in 4%, gout in 4%, and several other disorders at rates of 1% or less.

Among the rheumatoid arthritis patients, two-thirds were on a nonbiologic disease modifying drug, led by methotrexate in 65% of this subgroup and hydroxychloroquine in a third of the subgroup. A third of the entire study group was on treatment with a biologic or small-molecule drug. Etanercept (Enbrel) and adalimumab (Humira) led in this category with 8% of patients on each of these two drugs, followed by infliximab (Remicade) in 6%. Other usage rates in this category included abatacept (Orencia) in 4%, and tocilizumab (Actemra) and tofacitinib (Xeljanz) each used in about 2% of rheumatoid arthritis patients.

[email protected]

On Twitter @mitchelzoler

DENVER – During early 2015, exactly a quarter of all patients seen in U.S. rheumatology practices were diagnosed with rheumatoid arthritis, and among them two-thirds received treatment with a disease modifying nonbiologic drug, based on data from more than 200,000 patients who enrolled in an American College of Rheumatology registry during that time.

That’s an example of some of the data now available in an EHR-based registry run by the ACR and open to participation by any U.S.-based rheumatologist, Kaleb Michaud, PhD, said at the annual meeting of the Spondyloarthritis Research and Treatment Network.

Mitchel L. Zoler/Frontline Medical News

The ACR’s Rheumatology Informatics System for Effectiveness (RISE) is an EHR-based registry of passive reporting that as of July 2016 had enrolled 614,738 U.S. patients treated by 1,284 providers in 213 practices, said Dr. Michaud, codirector of the National Data Bank for Rheumatic Diseases in Wichita, Kan., who works with the ACR on RISE as a volunteer.

Patient participation in RISE more than doubled during the past year, rising from 302,000 participating patients in September 2015. In addition to enrolling even more providers with more patients to participate, RISE’s organizers is also now seeking investigators who can use the data collected in RISE to address useful research questions, he said.

RISE has been designated a qualified clinical data registry (QCDR) by the Centers for Medicare & Medicaid Services. If providers using RISE sign an agreement stating that they want to participate for quality reporting purposes, it then happens automatically. Participating practices also meet Medicare’s meaningful use measure of reporting to a specialty registry. Although most rheumatologists with academic positions already have these opportunities, for community rheumatologists this access is “a perq,” Dr. Michaud said.

As just an example of the data trove accumulating in RISE, Dr, Michaud rattled off some quick figures culled from analysis of the 239,302 RISE patients in 55 U.S. practices who entered the registry during October 2014-September 2015. The patients averaged 59 years of age, three quarters were women, 61% were white, 48% had commercial insurance and 30% were covered through Medicare.

Their most recent diagnosis was rheumatoid arthritis in 25%, unspecified myalgia or myositis in 21%, Sjögren’s syndrome in 7%, systemic lupus erythematosus in 6%, psoriatic arthritis in 6%, spondyloarthritides in 4%, gout in 4%, and several other disorders at rates of 1% or less.

Among the rheumatoid arthritis patients, two-thirds were on a nonbiologic disease modifying drug, led by methotrexate in 65% of this subgroup and hydroxychloroquine in a third of the subgroup. A third of the entire study group was on treatment with a biologic or small-molecule drug. Etanercept (Enbrel) and adalimumab (Humira) led in this category with 8% of patients on each of these two drugs, followed by infliximab (Remicade) in 6%. Other usage rates in this category included abatacept (Orencia) in 4%, and tocilizumab (Actemra) and tofacitinib (Xeljanz) each used in about 2% of rheumatoid arthritis patients.

[email protected]

On Twitter @mitchelzoler

DENVER – During early 2015, exactly a quarter of all patients seen in U.S. rheumatology practices were diagnosed with rheumatoid arthritis, and among them two-thirds received treatment with a disease modifying nonbiologic drug, based on data from more than 200,000 patients who enrolled in an American College of Rheumatology registry during that time.

That’s an example of some of the data now available in an EHR-based registry run by the ACR and open to participation by any U.S.-based rheumatologist, Kaleb Michaud, PhD, said at the annual meeting of the Spondyloarthritis Research and Treatment Network.

Mitchel L. Zoler/Frontline Medical News

The ACR’s Rheumatology Informatics System for Effectiveness (RISE) is an EHR-based registry of passive reporting that as of July 2016 had enrolled 614,738 U.S. patients treated by 1,284 providers in 213 practices, said Dr. Michaud, codirector of the National Data Bank for Rheumatic Diseases in Wichita, Kan., who works with the ACR on RISE as a volunteer.

Patient participation in RISE more than doubled during the past year, rising from 302,000 participating patients in September 2015. In addition to enrolling even more providers with more patients to participate, RISE’s organizers is also now seeking investigators who can use the data collected in RISE to address useful research questions, he said.

RISE has been designated a qualified clinical data registry (QCDR) by the Centers for Medicare & Medicaid Services. If providers using RISE sign an agreement stating that they want to participate for quality reporting purposes, it then happens automatically. Participating practices also meet Medicare’s meaningful use measure of reporting to a specialty registry. Although most rheumatologists with academic positions already have these opportunities, for community rheumatologists this access is “a perq,” Dr. Michaud said.

As just an example of the data trove accumulating in RISE, Dr, Michaud rattled off some quick figures culled from analysis of the 239,302 RISE patients in 55 U.S. practices who entered the registry during October 2014-September 2015. The patients averaged 59 years of age, three quarters were women, 61% were white, 48% had commercial insurance and 30% were covered through Medicare.

Their most recent diagnosis was rheumatoid arthritis in 25%, unspecified myalgia or myositis in 21%, Sjögren’s syndrome in 7%, systemic lupus erythematosus in 6%, psoriatic arthritis in 6%, spondyloarthritides in 4%, gout in 4%, and several other disorders at rates of 1% or less.

Among the rheumatoid arthritis patients, two-thirds were on a nonbiologic disease modifying drug, led by methotrexate in 65% of this subgroup and hydroxychloroquine in a third of the subgroup. A third of the entire study group was on treatment with a biologic or small-molecule drug. Etanercept (Enbrel) and adalimumab (Humira) led in this category with 8% of patients on each of these two drugs, followed by infliximab (Remicade) in 6%. Other usage rates in this category included abatacept (Orencia) in 4%, and tocilizumab (Actemra) and tofacitinib (Xeljanz) each used in about 2% of rheumatoid arthritis patients.

[email protected]

On Twitter @mitchelzoler

A model incorporating 17 easily obtainable preoperative variables may help clinicians estimate patients’ risk of developing pneumonia after undergoing coronary artery bypass graft surgery, according to a report published in Annals of Thoracic Surgery.

“This model may be used to inform clinician-patient decision making and to identify opportunities for mitigating a patient’s risk,” said Raymond J. Strobel, a medical student at the University of Michigan, Ann Arbor, and his associates.

American Heart Association

Postoperative pneumonia is the most common hospital-acquired infection following CABG, and it raises mortality risk fourfold and increases length of stay threefold. But reliable estimation of patient risk of post-CABG pneumonia has been difficult because of its low relative incidence – roughly 3% – and because most studies of the disorder are nearly a decade out of date.

To devise a predictive model using current data, Mr. Strobel and his associates assessed numerous potential risk factors and outcomes for 16,084 consecutive patients undergoing CABG at all 33 cardiac centers across Michigan during a 3-year period. They identified 531 cases of post-CABG pneumonia (3.3%) in this cohort.

The investigators performed a univariate analysis to test the associations between pneumonia and numerous factors related to patient demographics, medical history, comorbid diseases, laboratory values, cardiac anatomy, cardiac function, pulmonary function, the CABG procedure, and the institution where the procedure was performed. Variables that were found to be significantly associated with pneumonia (though usually with small absolute magnitudes) were then assessed in a multivariate analysis, which was further refined to create the final model.

The final model includes 17 factors that clearly raise the risk of post-CABG pneumonia. These include an elevated leukocyte count; a decreased hematocrit; older patient age; comorbidities such as peripheral vascular disease, diabetes, and liver disease; markers of pulmonary impairment such as cigarette smoking, the need for home oxygen therapy, and chronic lung disease; markers of cardiac dysfunction such as a recent history of arrhythmia and decreased ejection fraction; and emergency or urgent rather than elective operative status.

“This model performs well and demonstrates robustness across important clinical subgroups and centers,” the investigators said (Ann Thorac Surg. 2016 Jun 1; doi: 10.1016/j.athoracsur.2016.03.074).

In particular, this study identified preoperative leukocytosis to be a significant predictor of post-CABG pneumonia across several subgroups of patients. “We speculate that patients presenting with an elevated white blood cell count before surgery may be mounting an immune response against a pathogen and that the insult of CABG significantly increases their odds of postoperative pneumonia. ... It may be prudent to delay surgery until the source of leukocytosis is satisfactorily investigated, if not identified and treated, or the leukocytosis has otherwise resolved,” Mr. Strobel and his associates noted.

A model incorporating 17 easily obtainable preoperative variables may help clinicians estimate patients’ risk of developing pneumonia after undergoing coronary artery bypass graft surgery, according to a report published in Annals of Thoracic Surgery.

“This model may be used to inform clinician-patient decision making and to identify opportunities for mitigating a patient’s risk,” said Raymond J. Strobel, a medical student at the University of Michigan, Ann Arbor, and his associates.

American Heart Association

Postoperative pneumonia is the most common hospital-acquired infection following CABG, and it raises mortality risk fourfold and increases length of stay threefold. But reliable estimation of patient risk of post-CABG pneumonia has been difficult because of its low relative incidence – roughly 3% – and because most studies of the disorder are nearly a decade out of date.

To devise a predictive model using current data, Mr. Strobel and his associates assessed numerous potential risk factors and outcomes for 16,084 consecutive patients undergoing CABG at all 33 cardiac centers across Michigan during a 3-year period. They identified 531 cases of post-CABG pneumonia (3.3%) in this cohort.

The investigators performed a univariate analysis to test the associations between pneumonia and numerous factors related to patient demographics, medical history, comorbid diseases, laboratory values, cardiac anatomy, cardiac function, pulmonary function, the CABG procedure, and the institution where the procedure was performed. Variables that were found to be significantly associated with pneumonia (though usually with small absolute magnitudes) were then assessed in a multivariate analysis, which was further refined to create the final model.

The final model includes 17 factors that clearly raise the risk of post-CABG pneumonia. These include an elevated leukocyte count; a decreased hematocrit; older patient age; comorbidities such as peripheral vascular disease, diabetes, and liver disease; markers of pulmonary impairment such as cigarette smoking, the need for home oxygen therapy, and chronic lung disease; markers of cardiac dysfunction such as a recent history of arrhythmia and decreased ejection fraction; and emergency or urgent rather than elective operative status.

“This model performs well and demonstrates robustness across important clinical subgroups and centers,” the investigators said (Ann Thorac Surg. 2016 Jun 1; doi: 10.1016/j.athoracsur.2016.03.074).

In particular, this study identified preoperative leukocytosis to be a significant predictor of post-CABG pneumonia across several subgroups of patients. “We speculate that patients presenting with an elevated white blood cell count before surgery may be mounting an immune response against a pathogen and that the insult of CABG significantly increases their odds of postoperative pneumonia. ... It may be prudent to delay surgery until the source of leukocytosis is satisfactorily investigated, if not identified and treated, or the leukocytosis has otherwise resolved,” Mr. Strobel and his associates noted.

A model incorporating 17 easily obtainable preoperative variables may help clinicians estimate patients’ risk of developing pneumonia after undergoing coronary artery bypass graft surgery, according to a report published in Annals of Thoracic Surgery.

“This model may be used to inform clinician-patient decision making and to identify opportunities for mitigating a patient’s risk,” said Raymond J. Strobel, a medical student at the University of Michigan, Ann Arbor, and his associates.

American Heart Association

Postoperative pneumonia is the most common hospital-acquired infection following CABG, and it raises mortality risk fourfold and increases length of stay threefold. But reliable estimation of patient risk of post-CABG pneumonia has been difficult because of its low relative incidence – roughly 3% – and because most studies of the disorder are nearly a decade out of date.

To devise a predictive model using current data, Mr. Strobel and his associates assessed numerous potential risk factors and outcomes for 16,084 consecutive patients undergoing CABG at all 33 cardiac centers across Michigan during a 3-year period. They identified 531 cases of post-CABG pneumonia (3.3%) in this cohort.

The investigators performed a univariate analysis to test the associations between pneumonia and numerous factors related to patient demographics, medical history, comorbid diseases, laboratory values, cardiac anatomy, cardiac function, pulmonary function, the CABG procedure, and the institution where the procedure was performed. Variables that were found to be significantly associated with pneumonia (though usually with small absolute magnitudes) were then assessed in a multivariate analysis, which was further refined to create the final model.

The final model includes 17 factors that clearly raise the risk of post-CABG pneumonia. These include an elevated leukocyte count; a decreased hematocrit; older patient age; comorbidities such as peripheral vascular disease, diabetes, and liver disease; markers of pulmonary impairment such as cigarette smoking, the need for home oxygen therapy, and chronic lung disease; markers of cardiac dysfunction such as a recent history of arrhythmia and decreased ejection fraction; and emergency or urgent rather than elective operative status.

“This model performs well and demonstrates robustness across important clinical subgroups and centers,” the investigators said (Ann Thorac Surg. 2016 Jun 1; doi: 10.1016/j.athoracsur.2016.03.074).

In particular, this study identified preoperative leukocytosis to be a significant predictor of post-CABG pneumonia across several subgroups of patients. “We speculate that patients presenting with an elevated white blood cell count before surgery may be mounting an immune response against a pathogen and that the insult of CABG significantly increases their odds of postoperative pneumonia. ... It may be prudent to delay surgery until the source of leukocytosis is satisfactorily investigated, if not identified and treated, or the leukocytosis has otherwise resolved,” Mr. Strobel and his associates noted.

ORLANDO – Screening urinalysis should be a part of routine care for children and young adults with hemophilia, although the clinical significance of the finding is still unclear, investigators say.

Among 93 boys and young men with hemophilia A or B followed at a hemophilia treatment center, nearly half were found to have hematuria on routine screening, a possible indicator for future renal problems, said Kyle Davis, MD, and Amy Dunn, MD, from the division of hematology at Nationwide Children’s Hospital in Columbus, Ohio.

Neil Osterweil/Frontline Medical News

“It’s not routine for all centers to screen for hematuria, so there is likely a large number of patients that are underrecognized, who have hematuria but we don’t even know it,” Dr. Davis said in an interview at the World Federation of Hemophilia World Congress.

Hematuria is a recognized complication in patients with hemophilia A and B, second only to joint damage in frequency. In addition, adults with hemophilia have been shown to have a higher prevalence of renal disease than the general population, suggesting that hematuria might be a marker or harbinger of later renal disease, the authors proposed in a scientific poster.

The investigators conducted their study as part of a quality improvement program at their center aimed at increasing the frequency of urine screening in patients with hemophilia during annual comprehensive visits.

They looked at urinalysis results collected from all male patients older than 2 years with hemophilia A or B seen at their center from August 2011 through September 2015. They defined hematuria as the presence of three or more red blood cells on at least one urinalysis sample.

They also performed univariate logistic regression to evaluate the association of hematuria with patient age, race, hemophilia type and severity, treatment regimen, and history of inhibitory antibodies.

A total of 93 patients, 67 with hemophilia A and 26 with hemophilia B, were included. In all, 43 patients (47%) were identified as having hematuria, with a median of seven red cells. Hematuria was seen in 37 patients with hemophilia A (55%), and in 6 patients with hemophilia B (23%).

Characteristics associated with risk for hematuria included older age and hemophilia A.

Imaging studies available on 24 of the 93 patients showed renal calculi in 3 patients, minor pelviectasis in 1, and congenital dysplastic left kidney, ureterocele, and right hydroureter in 1 patient.

Dr. Davis and Dr. Dunn said that while screening urinalysis could be considered as a part of routine hemophilia, additional studies are needed to replicate the finding in other treatment centers and to determine whether urinalysis results can be predictive of future renal disease, and if so, whether interventions might help.

“For example, there is the potential that if you recognize hematuria in a patient and that patient is currently on an on-demand treatment process, should we switch to prophylaxis?” Dr Davis said.

Dr. Dunn noted that “certainly there are high-risk populations who should be screened, like our patients who have an active inhibitor or even a tolerized inhibitor. Our data suggest that we ought to be looking a bit more closely at those patients, and perhaps that will help us tease out the cause of this. Can we blame it all on hemophilia, or is there something else going on?”

The study was internally funded. Dr. Davis and Dr. Dunn reported no relevant disclosures.

ORLANDO – Screening urinalysis should be a part of routine care for children and young adults with hemophilia, although the clinical significance of the finding is still unclear, investigators say.

Among 93 boys and young men with hemophilia A or B followed at a hemophilia treatment center, nearly half were found to have hematuria on routine screening, a possible indicator for future renal problems, said Kyle Davis, MD, and Amy Dunn, MD, from the division of hematology at Nationwide Children’s Hospital in Columbus, Ohio.

Neil Osterweil/Frontline Medical News

“It’s not routine for all centers to screen for hematuria, so there is likely a large number of patients that are underrecognized, who have hematuria but we don’t even know it,” Dr. Davis said in an interview at the World Federation of Hemophilia World Congress.

Hematuria is a recognized complication in patients with hemophilia A and B, second only to joint damage in frequency. In addition, adults with hemophilia have been shown to have a higher prevalence of renal disease than the general population, suggesting that hematuria might be a marker or harbinger of later renal disease, the authors proposed in a scientific poster.

The investigators conducted their study as part of a quality improvement program at their center aimed at increasing the frequency of urine screening in patients with hemophilia during annual comprehensive visits.

They looked at urinalysis results collected from all male patients older than 2 years with hemophilia A or B seen at their center from August 2011 through September 2015. They defined hematuria as the presence of three or more red blood cells on at least one urinalysis sample.

They also performed univariate logistic regression to evaluate the association of hematuria with patient age, race, hemophilia type and severity, treatment regimen, and history of inhibitory antibodies.

A total of 93 patients, 67 with hemophilia A and 26 with hemophilia B, were included. In all, 43 patients (47%) were identified as having hematuria, with a median of seven red cells. Hematuria was seen in 37 patients with hemophilia A (55%), and in 6 patients with hemophilia B (23%).

Characteristics associated with risk for hematuria included older age and hemophilia A.

Imaging studies available on 24 of the 93 patients showed renal calculi in 3 patients, minor pelviectasis in 1, and congenital dysplastic left kidney, ureterocele, and right hydroureter in 1 patient.

Dr. Davis and Dr. Dunn said that while screening urinalysis could be considered as a part of routine hemophilia, additional studies are needed to replicate the finding in other treatment centers and to determine whether urinalysis results can be predictive of future renal disease, and if so, whether interventions might help.

“For example, there is the potential that if you recognize hematuria in a patient and that patient is currently on an on-demand treatment process, should we switch to prophylaxis?” Dr Davis said.

Dr. Dunn noted that “certainly there are high-risk populations who should be screened, like our patients who have an active inhibitor or even a tolerized inhibitor. Our data suggest that we ought to be looking a bit more closely at those patients, and perhaps that will help us tease out the cause of this. Can we blame it all on hemophilia, or is there something else going on?”

The study was internally funded. Dr. Davis and Dr. Dunn reported no relevant disclosures.

ORLANDO – Screening urinalysis should be a part of routine care for children and young adults with hemophilia, although the clinical significance of the finding is still unclear, investigators say.

Among 93 boys and young men with hemophilia A or B followed at a hemophilia treatment center, nearly half were found to have hematuria on routine screening, a possible indicator for future renal problems, said Kyle Davis, MD, and Amy Dunn, MD, from the division of hematology at Nationwide Children’s Hospital in Columbus, Ohio.

Neil Osterweil/Frontline Medical News

“It’s not routine for all centers to screen for hematuria, so there is likely a large number of patients that are underrecognized, who have hematuria but we don’t even know it,” Dr. Davis said in an interview at the World Federation of Hemophilia World Congress.

Hematuria is a recognized complication in patients with hemophilia A and B, second only to joint damage in frequency. In addition, adults with hemophilia have been shown to have a higher prevalence of renal disease than the general population, suggesting that hematuria might be a marker or harbinger of later renal disease, the authors proposed in a scientific poster.

The investigators conducted their study as part of a quality improvement program at their center aimed at increasing the frequency of urine screening in patients with hemophilia during annual comprehensive visits.

They looked at urinalysis results collected from all male patients older than 2 years with hemophilia A or B seen at their center from August 2011 through September 2015. They defined hematuria as the presence of three or more red blood cells on at least one urinalysis sample.

They also performed univariate logistic regression to evaluate the association of hematuria with patient age, race, hemophilia type and severity, treatment regimen, and history of inhibitory antibodies.

A total of 93 patients, 67 with hemophilia A and 26 with hemophilia B, were included. In all, 43 patients (47%) were identified as having hematuria, with a median of seven red cells. Hematuria was seen in 37 patients with hemophilia A (55%), and in 6 patients with hemophilia B (23%).

Characteristics associated with risk for hematuria included older age and hemophilia A.

Imaging studies available on 24 of the 93 patients showed renal calculi in 3 patients, minor pelviectasis in 1, and congenital dysplastic left kidney, ureterocele, and right hydroureter in 1 patient.

Dr. Davis and Dr. Dunn said that while screening urinalysis could be considered as a part of routine hemophilia, additional studies are needed to replicate the finding in other treatment centers and to determine whether urinalysis results can be predictive of future renal disease, and if so, whether interventions might help.

“For example, there is the potential that if you recognize hematuria in a patient and that patient is currently on an on-demand treatment process, should we switch to prophylaxis?” Dr Davis said.

Dr. Dunn noted that “certainly there are high-risk populations who should be screened, like our patients who have an active inhibitor or even a tolerized inhibitor. Our data suggest that we ought to be looking a bit more closely at those patients, and perhaps that will help us tease out the cause of this. Can we blame it all on hemophilia, or is there something else going on?”

The study was internally funded. Dr. Davis and Dr. Dunn reported no relevant disclosures.

DURBAN, SOUTH AFRICA – The use of efavirenz in HIV-infected participants in the landmark START trial was associated with significantly increased risk of suicidal behavior, Alejandro Arenas-Pinto, MD, reported at the 21st International AIDS Conference.

“The impact of efavirenz exposure was particularly high in those with a prior psychiatric diagnosis,” according to the infectious diseases specialist. “The message here is that it’s probably just those patients with preexisting neuropsychiatric conditions who are at higher risk of suicidal behavior, according to our data. This supports a recommendation to screen for preexisting depression and other neuropsychiatric conditions before efavirenz initiation.”

Bruce Jancin/Frontline Medical News

START was a clinical practice-transforming randomized trial that established a clear clinical benefit for a strategy of initiating antiretroviral therapy immediately upon diagnosis of HIV infection in asymptomatic adults instead of waiting until their CD4+ count drops below the level of 350 cells/mm³ (N Engl J Med. 2015 Aug 27;373[9]:795-807). Immediate antiretroviral therapy (ART) was associated with a 57% reduction in the risk of the primary outcome, a composite comprised of serious AIDS-defining events, serious non-AIDS adverse events, and all-cause mortality.

Once the results were in, however, Dr. Arenas-Pinto and the other START investigators quickly noticed that suicidal behavior was the second-most-common serious non-AIDS event observed in the study. A total of 57 patients were affected, for a rate of 0.36 events per 100 person-years of follow-up. There were 30 suicide attempts, 16 cases of suicidal ideation, 3 completed suicides, and 1 case each classified as intentional self-injury or self-injurious ideation. A closer look was warranted, said Dr. Arenas-Pinto of University College London.

The investigators next determined that the risk of suicidal behavior was significantly higher in the 3,516 START participants on efavirenz than in the 1,169 subjects on other ART drugs. The risk was 4.2-fold greater in patients who started on efavirenz immediately than in those randomized to begin the drug on a deferred basis. In contrast, suicidal behavior was no more frequent in patients who started on other ART medications immediately than if treatment was deferred.

In a multivariate Cox proportional hazards analysis of predictors of suicidal behavior in patients on efavirenz, the stand-out predictor was prior diagnosis of major depression, bipolar disorder, or schizophrenia or another psychotic disorder, with an associated 12.8-fold increased risk. Heavy alcohol use was associated with a 6.1-fold increased risk and ever having used recreational drugs conferred a 2.9-fold increased risk. In contrast, the risk of suicidal behavior in patients on efavirenz dropped sharply with advancing age.

Efavirenz is a non-nucleoside transcriptase inhibitor marketed as Sustiva, or when incorporated into once-daily, fixed-dose, triple-drug therapy with tenofovir/emtricitabine, as Atripla.

The labeling for efavirenz states that many of the drug’s more common side effects involve the brain. They include dizziness, insomnia, depression, anxiety, nightmares, hallucinations, delusions, and confusion.

The START study was funded by the National Institutes of Health. Dr. Arenas-Pinto reported having no financial conflicts of interest.

[email protected]

DURBAN, SOUTH AFRICA – The use of efavirenz in HIV-infected participants in the landmark START trial was associated with significantly increased risk of suicidal behavior, Alejandro Arenas-Pinto, MD, reported at the 21st International AIDS Conference.

“The impact of efavirenz exposure was particularly high in those with a prior psychiatric diagnosis,” according to the infectious diseases specialist. “The message here is that it’s probably just those patients with preexisting neuropsychiatric conditions who are at higher risk of suicidal behavior, according to our data. This supports a recommendation to screen for preexisting depression and other neuropsychiatric conditions before efavirenz initiation.”

Bruce Jancin/Frontline Medical News

START was a clinical practice-transforming randomized trial that established a clear clinical benefit for a strategy of initiating antiretroviral therapy immediately upon diagnosis of HIV infection in asymptomatic adults instead of waiting until their CD4+ count drops below the level of 350 cells/mm³ (N Engl J Med. 2015 Aug 27;373[9]:795-807). Immediate antiretroviral therapy (ART) was associated with a 57% reduction in the risk of the primary outcome, a composite comprised of serious AIDS-defining events, serious non-AIDS adverse events, and all-cause mortality.

Once the results were in, however, Dr. Arenas-Pinto and the other START investigators quickly noticed that suicidal behavior was the second-most-common serious non-AIDS event observed in the study. A total of 57 patients were affected, for a rate of 0.36 events per 100 person-years of follow-up. There were 30 suicide attempts, 16 cases of suicidal ideation, 3 completed suicides, and 1 case each classified as intentional self-injury or self-injurious ideation. A closer look was warranted, said Dr. Arenas-Pinto of University College London.

The investigators next determined that the risk of suicidal behavior was significantly higher in the 3,516 START participants on efavirenz than in the 1,169 subjects on other ART drugs. The risk was 4.2-fold greater in patients who started on efavirenz immediately than in those randomized to begin the drug on a deferred basis. In contrast, suicidal behavior was no more frequent in patients who started on other ART medications immediately than if treatment was deferred.

In a multivariate Cox proportional hazards analysis of predictors of suicidal behavior in patients on efavirenz, the stand-out predictor was prior diagnosis of major depression, bipolar disorder, or schizophrenia or another psychotic disorder, with an associated 12.8-fold increased risk. Heavy alcohol use was associated with a 6.1-fold increased risk and ever having used recreational drugs conferred a 2.9-fold increased risk. In contrast, the risk of suicidal behavior in patients on efavirenz dropped sharply with advancing age.

Efavirenz is a non-nucleoside transcriptase inhibitor marketed as Sustiva, or when incorporated into once-daily, fixed-dose, triple-drug therapy with tenofovir/emtricitabine, as Atripla.

The labeling for efavirenz states that many of the drug’s more common side effects involve the brain. They include dizziness, insomnia, depression, anxiety, nightmares, hallucinations, delusions, and confusion.

The START study was funded by the National Institutes of Health. Dr. Arenas-Pinto reported having no financial conflicts of interest.

[email protected]

DURBAN, SOUTH AFRICA – The use of efavirenz in HIV-infected participants in the landmark START trial was associated with significantly increased risk of suicidal behavior, Alejandro Arenas-Pinto, MD, reported at the 21st International AIDS Conference.

“The impact of efavirenz exposure was particularly high in those with a prior psychiatric diagnosis,” according to the infectious diseases specialist. “The message here is that it’s probably just those patients with preexisting neuropsychiatric conditions who are at higher risk of suicidal behavior, according to our data. This supports a recommendation to screen for preexisting depression and other neuropsychiatric conditions before efavirenz initiation.”

Bruce Jancin/Frontline Medical News

START was a clinical practice-transforming randomized trial that established a clear clinical benefit for a strategy of initiating antiretroviral therapy immediately upon diagnosis of HIV infection in asymptomatic adults instead of waiting until their CD4+ count drops below the level of 350 cells/mm³ (N Engl J Med. 2015 Aug 27;373[9]:795-807). Immediate antiretroviral therapy (ART) was associated with a 57% reduction in the risk of the primary outcome, a composite comprised of serious AIDS-defining events, serious non-AIDS adverse events, and all-cause mortality.

Once the results were in, however, Dr. Arenas-Pinto and the other START investigators quickly noticed that suicidal behavior was the second-most-common serious non-AIDS event observed in the study. A total of 57 patients were affected, for a rate of 0.36 events per 100 person-years of follow-up. There were 30 suicide attempts, 16 cases of suicidal ideation, 3 completed suicides, and 1 case each classified as intentional self-injury or self-injurious ideation. A closer look was warranted, said Dr. Arenas-Pinto of University College London.

The investigators next determined that the risk of suicidal behavior was significantly higher in the 3,516 START participants on efavirenz than in the 1,169 subjects on other ART drugs. The risk was 4.2-fold greater in patients who started on efavirenz immediately than in those randomized to begin the drug on a deferred basis. In contrast, suicidal behavior was no more frequent in patients who started on other ART medications immediately than if treatment was deferred.

In a multivariate Cox proportional hazards analysis of predictors of suicidal behavior in patients on efavirenz, the stand-out predictor was prior diagnosis of major depression, bipolar disorder, or schizophrenia or another psychotic disorder, with an associated 12.8-fold increased risk. Heavy alcohol use was associated with a 6.1-fold increased risk and ever having used recreational drugs conferred a 2.9-fold increased risk. In contrast, the risk of suicidal behavior in patients on efavirenz dropped sharply with advancing age.

Efavirenz is a non-nucleoside transcriptase inhibitor marketed as Sustiva, or when incorporated into once-daily, fixed-dose, triple-drug therapy with tenofovir/emtricitabine, as Atripla.

The labeling for efavirenz states that many of the drug’s more common side effects involve the brain. They include dizziness, insomnia, depression, anxiety, nightmares, hallucinations, delusions, and confusion.

The START study was funded by the National Institutes of Health. Dr. Arenas-Pinto reported having no financial conflicts of interest.

[email protected]

Boston – Autoinflammatory and autoimmune disorders in children have many overlapping features, but the former represents a malfunction of the innate immune system, and the latter a malfunction of the adaptive immune system. Fevers, skin eruptions, joint pain and swelling, fatigue, and growth failure can occur in both, but it is important to identify the underlying problem, according to Raegan Hunt, MD.

Autoinflammatory disorders can be difficult to detect, so it is important to maintain a high index of suspicion for them, Dr. Hunt of Baylor College of Medicine and Texas Children’s Hospital, Houston, said at the American Academy of Dermatology annual summer meeting.

She discussed five signs of possible autoinflammatory disease in children, as described in a recent report by Hal M. Hoffman, MD, and Lori Broderick, MD, of Children’s Hospital of San Diego, La Jolla, Calif. (J Allergy Clin Immunol. July 2016; 138:3-14)*:

1. More than three episodes of fever over 101 degrees Farenheit with no explained infectious etiology.

2. Having predictable patterns of characteristic course of each episode.

3. Having specific symptoms during episodes, including nonpruritic skin eruptions, joint or bone pain, severe abdominal pain, and conjunctivitis, with no upper respiratory infection symptoms.

4. Episodes may be triggered by specific stimuli, such as cold exposure or vaccines.

5. A family history of autoinflammatory disease or amyloidosis.

The authors “propose that two or more of these might suggest that an autoinflammatory disorder is possible and should be investigated,” Dr. Hunt said.

Dr. Hunt reported having no relevant disclosures.

[email protected]

*Correction, 8/16/16: An earlier version of this article failed to note that Dr. Lori Broderick was a co-investigator in the cited report.

Boston – Autoinflammatory and autoimmune disorders in children have many overlapping features, but the former represents a malfunction of the innate immune system, and the latter a malfunction of the adaptive immune system. Fevers, skin eruptions, joint pain and swelling, fatigue, and growth failure can occur in both, but it is important to identify the underlying problem, according to Raegan Hunt, MD.

Autoinflammatory disorders can be difficult to detect, so it is important to maintain a high index of suspicion for them, Dr. Hunt of Baylor College of Medicine and Texas Children’s Hospital, Houston, said at the American Academy of Dermatology annual summer meeting.

She discussed five signs of possible autoinflammatory disease in children, as described in a recent report by Hal M. Hoffman, MD, and Lori Broderick, MD, of Children’s Hospital of San Diego, La Jolla, Calif. (J Allergy Clin Immunol. July 2016; 138:3-14)*:

1. More than three episodes of fever over 101 degrees Farenheit with no explained infectious etiology.

2. Having predictable patterns of characteristic course of each episode.

3. Having specific symptoms during episodes, including nonpruritic skin eruptions, joint or bone pain, severe abdominal pain, and conjunctivitis, with no upper respiratory infection symptoms.

4. Episodes may be triggered by specific stimuli, such as cold exposure or vaccines.

5. A family history of autoinflammatory disease or amyloidosis.

The authors “propose that two or more of these might suggest that an autoinflammatory disorder is possible and should be investigated,” Dr. Hunt said.

Dr. Hunt reported having no relevant disclosures.

[email protected]

*Correction, 8/16/16: An earlier version of this article failed to note that Dr. Lori Broderick was a co-investigator in the cited report.

Boston – Autoinflammatory and autoimmune disorders in children have many overlapping features, but the former represents a malfunction of the innate immune system, and the latter a malfunction of the adaptive immune system. Fevers, skin eruptions, joint pain and swelling, fatigue, and growth failure can occur in both, but it is important to identify the underlying problem, according to Raegan Hunt, MD.

Autoinflammatory disorders can be difficult to detect, so it is important to maintain a high index of suspicion for them, Dr. Hunt of Baylor College of Medicine and Texas Children’s Hospital, Houston, said at the American Academy of Dermatology annual summer meeting.

She discussed five signs of possible autoinflammatory disease in children, as described in a recent report by Hal M. Hoffman, MD, and Lori Broderick, MD, of Children’s Hospital of San Diego, La Jolla, Calif. (J Allergy Clin Immunol. July 2016; 138:3-14)*:

1. More than three episodes of fever over 101 degrees Farenheit with no explained infectious etiology.

2. Having predictable patterns of characteristic course of each episode.

3. Having specific symptoms during episodes, including nonpruritic skin eruptions, joint or bone pain, severe abdominal pain, and conjunctivitis, with no upper respiratory infection symptoms.

4. Episodes may be triggered by specific stimuli, such as cold exposure or vaccines.

5. A family history of autoinflammatory disease or amyloidosis.

The authors “propose that two or more of these might suggest that an autoinflammatory disorder is possible and should be investigated,” Dr. Hunt said.

Dr. Hunt reported having no relevant disclosures.

[email protected]

*Correction, 8/16/16: An earlier version of this article failed to note that Dr. Lori Broderick was a co-investigator in the cited report.

The normal fungal communities that inhabit healthy skin are much more diverse in children than adults, a new study has discovered.

That diversity dwindles, however, around puberty, when the lipophilic taxa Malassezia surges in abundance. This is probably mediated by the increase in sebaceous gland activation and sebum composition that occurs around sexual maturity, Jay-Hyun Jo, PhD, wrote (J Invest Dermatol. 2016 Jul 28; doi: 10.1016/j.jid.2016.05.130).

The diversity of the childhood mycobiome may also play into the larger prevalence of fungal skin diseases in children, wrote Dr. Jo of the National Cancer Institute.

“Several fungal skin infections (dermatophytoses), such as tinea capitis and tinea corporis, are more frequently seen in children. This epidemiological dichotomy in fungal infections may relate to the physiologic characteristics of younger skin, which appears more permissive to colonization by diverse fungi.”

The researchers used the fungal internal transcribed spacer–1 (ITS1) sequence to pinpoint the taxonomic details of the mycobiome of 14 healthy children and 19 healthy adults. They looked at samples from 10 sites on each subject: the external auditory canal, forehead, occiput, retroauricular crease, back, manubrium, antecubital fossa, inguinal crease, volar forearm, and nares.

Malassezia monopolized the adult samples, constituting 80%-99% of the communities on each skin site. In children, however, Malassezia was much less common, comprising 35%-76% of the samples of each site.

However, children boasted a much more diverse mycobiome. Other constituents included members of the Ascomycota, Aspergillus, Epicoccum, and Phoma taxae. Ascomycota species were found on 40% of samples from children, compared with 9.5% of samples from adults. Children also played host to communities of Epicoccum, Cladosporium, and Cryptococcus.

There were individual variations in diversity, however, the authors noted. “For clinical samples from children, decreased diversity was correlated with increased relative abundance of Malassezia, especially on sebaceous sites. Given the predominance of Malassezia on sebaceous skin, it is possible that reduction in diversity was attributed to relative overexpansion of Malassezia.”

The team also discovered gender differences in the mycobiome of children. The sebaceous skin sites of boys were much more likely to host species of Epicoccum and Cryptococcus. Girls showed an early enrichment of Malassezia. “These results suggested that gender may affect mycobiome structures during sexual maturation.”

“Since Malassezia is an obligatory lipophilic fungus, differential Malassezia abundance might be due to the full activation of sebaceous glands during puberty,” they theorized. “Therefore, it would be intriguing to identify the sebaceous gland activity and sebum signatures during childhood in conjunction with sequence-based mycobiome analysis.”

The National Institutes of Health funded the study. Dr. Jo had no financial disclosures.

[email protected]

On Twitter @Alz_Gal

The normal fungal communities that inhabit healthy skin are much more diverse in children than adults, a new study has discovered.

That diversity dwindles, however, around puberty, when the lipophilic taxa Malassezia surges in abundance. This is probably mediated by the increase in sebaceous gland activation and sebum composition that occurs around sexual maturity, Jay-Hyun Jo, PhD, wrote (J Invest Dermatol. 2016 Jul 28; doi: 10.1016/j.jid.2016.05.130).

The diversity of the childhood mycobiome may also play into the larger prevalence of fungal skin diseases in children, wrote Dr. Jo of the National Cancer Institute.

“Several fungal skin infections (dermatophytoses), such as tinea capitis and tinea corporis, are more frequently seen in children. This epidemiological dichotomy in fungal infections may relate to the physiologic characteristics of younger skin, which appears more permissive to colonization by diverse fungi.”

The researchers used the fungal internal transcribed spacer–1 (ITS1) sequence to pinpoint the taxonomic details of the mycobiome of 14 healthy children and 19 healthy adults. They looked at samples from 10 sites on each subject: the external auditory canal, forehead, occiput, retroauricular crease, back, manubrium, antecubital fossa, inguinal crease, volar forearm, and nares.

Malassezia monopolized the adult samples, constituting 80%-99% of the communities on each skin site. In children, however, Malassezia was much less common, comprising 35%-76% of the samples of each site.

However, children boasted a much more diverse mycobiome. Other constituents included members of the Ascomycota, Aspergillus, Epicoccum, and Phoma taxae. Ascomycota species were found on 40% of samples from children, compared with 9.5% of samples from adults. Children also played host to communities of Epicoccum, Cladosporium, and Cryptococcus.

There were individual variations in diversity, however, the authors noted. “For clinical samples from children, decreased diversity was correlated with increased relative abundance of Malassezia, especially on sebaceous sites. Given the predominance of Malassezia on sebaceous skin, it is possible that reduction in diversity was attributed to relative overexpansion of Malassezia.”

The team also discovered gender differences in the mycobiome of children. The sebaceous skin sites of boys were much more likely to host species of Epicoccum and Cryptococcus. Girls showed an early enrichment of Malassezia. “These results suggested that gender may affect mycobiome structures during sexual maturation.”

“Since Malassezia is an obligatory lipophilic fungus, differential Malassezia abundance might be due to the full activation of sebaceous glands during puberty,” they theorized. “Therefore, it would be intriguing to identify the sebaceous gland activity and sebum signatures during childhood in conjunction with sequence-based mycobiome analysis.”

The National Institutes of Health funded the study. Dr. Jo had no financial disclosures.

[email protected]

On Twitter @Alz_Gal

The normal fungal communities that inhabit healthy skin are much more diverse in children than adults, a new study has discovered.

That diversity dwindles, however, around puberty, when the lipophilic taxa Malassezia surges in abundance. This is probably mediated by the increase in sebaceous gland activation and sebum composition that occurs around sexual maturity, Jay-Hyun Jo, PhD, wrote (J Invest Dermatol. 2016 Jul 28; doi: 10.1016/j.jid.2016.05.130).

The diversity of the childhood mycobiome may also play into the larger prevalence of fungal skin diseases in children, wrote Dr. Jo of the National Cancer Institute.

“Several fungal skin infections (dermatophytoses), such as tinea capitis and tinea corporis, are more frequently seen in children. This epidemiological dichotomy in fungal infections may relate to the physiologic characteristics of younger skin, which appears more permissive to colonization by diverse fungi.”

The researchers used the fungal internal transcribed spacer–1 (ITS1) sequence to pinpoint the taxonomic details of the mycobiome of 14 healthy children and 19 healthy adults. They looked at samples from 10 sites on each subject: the external auditory canal, forehead, occiput, retroauricular crease, back, manubrium, antecubital fossa, inguinal crease, volar forearm, and nares.

Malassezia monopolized the adult samples, constituting 80%-99% of the communities on each skin site. In children, however, Malassezia was much less common, comprising 35%-76% of the samples of each site.

However, children boasted a much more diverse mycobiome. Other constituents included members of the Ascomycota, Aspergillus, Epicoccum, and Phoma taxae. Ascomycota species were found on 40% of samples from children, compared with 9.5% of samples from adults. Children also played host to communities of Epicoccum, Cladosporium, and Cryptococcus.

There were individual variations in diversity, however, the authors noted. “For clinical samples from children, decreased diversity was correlated with increased relative abundance of Malassezia, especially on sebaceous sites. Given the predominance of Malassezia on sebaceous skin, it is possible that reduction in diversity was attributed to relative overexpansion of Malassezia.”

The team also discovered gender differences in the mycobiome of children. The sebaceous skin sites of boys were much more likely to host species of Epicoccum and Cryptococcus. Girls showed an early enrichment of Malassezia. “These results suggested that gender may affect mycobiome structures during sexual maturation.”

“Since Malassezia is an obligatory lipophilic fungus, differential Malassezia abundance might be due to the full activation of sebaceous glands during puberty,” they theorized. “Therefore, it would be intriguing to identify the sebaceous gland activity and sebum signatures during childhood in conjunction with sequence-based mycobiome analysis.”

The National Institutes of Health funded the study. Dr. Jo had no financial disclosures.

[email protected]

On Twitter @Alz_Gal

BOSTON – An investigation into 18 nosocomial Candida auris infections at a tertiary care center in Venezuela showed that isolates of the emerging fungal pathogen obtained during the outbreak were resistant to fluconazole and voriconazole. However, the isolates were intermediately susceptible to amphotericin B and susceptible to 5-fluorocitosine, and demonstrated high susceptibility to the candin antifungal anidulafungin.

Dr. Belinda Calvo, an infectious disease specialist at the University of Maracaibo, Venezuela, and her collaborators reported these findings, related to a 2012-2013 C. auris outbreak at the hospital. Dr. Calvo and her coinvestigators noted that other invasive C. auris outbreaks have been reported in India, Korea, and South Africa, but that “the real prevalence of this organism may be underestimated,” since common rapid microbial identification techniques may misidentify the species.

In a poster session at the annual meeting of the American Society of Microbiology, Dr. Calvo and her collaborators reported that the 18 patients involved in the Venezuelan outbreak were critically ill, of whom 11 were pediatric, and all had central venous catheter placement. All but two of the pediatric patients were neonates, and all had serious underlying morbidities; several had significant congenital anomalies. The median patient age was 26 days (range, 2 days to 72 years), reflecting the high number of neonates affected. One of the adult patients had esophageal carcinoma. Overall, 10/18 patients (56%) had undergone surgical procedures, and all had received antibiotics.

As has been reported in other C. auris outbreaks, isolates from blood cultures of affected individuals were initially reported as C. haemulonii by the Vitek 2 C automated microbial identification system. Molecular identification was completed by sequencing the internal transcribed spacer (ITS) of the rDNA gene, with analysis aided by the National Institutes of Health’s GenBank and the Netherland’s CBS Fungal Diversity Centre , in order to confirm the identity of the fungal isolates as C. auris. Dr. Calvo and her associates were able to generate a dendrogram of the 18 isolates, showing high clonality, a trait shared with other nosocomial C. auris outbreaks.

Susceptibility testing of the C. auris cultured from blood samples of the affected patients showed that fluconazole had a minimum inhibitory concentration to inhibit the growth of 50% of the organisms (MIC₅₀₎ of greater than 64 mcg/mL. For fluconazole, the MIC₉₀, range, and geometric mean were all also above 64 mcg/mL, indicating a high level of resistance. For voriconazole, the MICs, range, and mean were all 4 mcg/mL. For amphotericin B, the MIC₅₀ was 1 mcg/mL, the MIC₉₀ was 2 mcg/mL, the range was 1-2, and the geometric mean was 1.414 mcg/mL.

The high number of pediatric patients affected, as well as early pathogen identification with speedy and appropriate antifungal therapy and prompt removal of central venous catheters, likely contributed to the relatively low 30-day crude mortality rate of 28%, said Dr. Calvo and her coauthors.

“C. auris should be considered an emergent multiresistant species,” wrote Dr. Calbo and her collaborators, noting that the opportunistic pathogen has a “high potential for nosocomial horizontal transmission.”

In June 2016, the Centers for Disease Control issued a clinical alert to U.S. healthcare facilities regarding the global emergence of invasive infections caused by C. auris.

The study authors reported no external sources of funding and no conflicts of interest.

[email protected]

On Twitter @karioakes

BOSTON – An investigation into 18 nosocomial Candida auris infections at a tertiary care center in Venezuela showed that isolates of the emerging fungal pathogen obtained during the outbreak were resistant to fluconazole and voriconazole. However, the isolates were intermediately susceptible to amphotericin B and susceptible to 5-fluorocitosine, and demonstrated high susceptibility to the candin antifungal anidulafungin.

Dr. Belinda Calvo, an infectious disease specialist at the University of Maracaibo, Venezuela, and her collaborators reported these findings, related to a 2012-2013 C. auris outbreak at the hospital. Dr. Calvo and her coinvestigators noted that other invasive C. auris outbreaks have been reported in India, Korea, and South Africa, but that “the real prevalence of this organism may be underestimated,” since common rapid microbial identification techniques may misidentify the species.

In a poster session at the annual meeting of the American Society of Microbiology, Dr. Calvo and her collaborators reported that the 18 patients involved in the Venezuelan outbreak were critically ill, of whom 11 were pediatric, and all had central venous catheter placement. All but two of the pediatric patients were neonates, and all had serious underlying morbidities; several had significant congenital anomalies. The median patient age was 26 days (range, 2 days to 72 years), reflecting the high number of neonates affected. One of the adult patients had esophageal carcinoma. Overall, 10/18 patients (56%) had undergone surgical procedures, and all had received antibiotics.

As has been reported in other C. auris outbreaks, isolates from blood cultures of affected individuals were initially reported as C. haemulonii by the Vitek 2 C automated microbial identification system. Molecular identification was completed by sequencing the internal transcribed spacer (ITS) of the rDNA gene, with analysis aided by the National Institutes of Health’s GenBank and the Netherland’s CBS Fungal Diversity Centre , in order to confirm the identity of the fungal isolates as C. auris. Dr. Calvo and her associates were able to generate a dendrogram of the 18 isolates, showing high clonality, a trait shared with other nosocomial C. auris outbreaks.

Susceptibility testing of the C. auris cultured from blood samples of the affected patients showed that fluconazole had a minimum inhibitory concentration to inhibit the growth of 50% of the organisms (MIC₅₀₎ of greater than 64 mcg/mL. For fluconazole, the MIC₉₀, range, and geometric mean were all also above 64 mcg/mL, indicating a high level of resistance. For voriconazole, the MICs, range, and mean were all 4 mcg/mL. For amphotericin B, the MIC₅₀ was 1 mcg/mL, the MIC₉₀ was 2 mcg/mL, the range was 1-2, and the geometric mean was 1.414 mcg/mL.

The high number of pediatric patients affected, as well as early pathogen identification with speedy and appropriate antifungal therapy and prompt removal of central venous catheters, likely contributed to the relatively low 30-day crude mortality rate of 28%, said Dr. Calvo and her coauthors.

“C. auris should be considered an emergent multiresistant species,” wrote Dr. Calbo and her collaborators, noting that the opportunistic pathogen has a “high potential for nosocomial horizontal transmission.”

In June 2016, the Centers for Disease Control issued a clinical alert to U.S. healthcare facilities regarding the global emergence of invasive infections caused by C. auris.

The study authors reported no external sources of funding and no conflicts of interest.

[email protected]

On Twitter @karioakes

BOSTON – An investigation into 18 nosocomial Candida auris infections at a tertiary care center in Venezuela showed that isolates of the emerging fungal pathogen obtained during the outbreak were resistant to fluconazole and voriconazole. However, the isolates were intermediately susceptible to amphotericin B and susceptible to 5-fluorocitosine, and demonstrated high susceptibility to the candin antifungal anidulafungin.

Dr. Belinda Calvo, an infectious disease specialist at the University of Maracaibo, Venezuela, and her collaborators reported these findings, related to a 2012-2013 C. auris outbreak at the hospital. Dr. Calvo and her coinvestigators noted that other invasive C. auris outbreaks have been reported in India, Korea, and South Africa, but that “the real prevalence of this organism may be underestimated,” since common rapid microbial identification techniques may misidentify the species.

In a poster session at the annual meeting of the American Society of Microbiology, Dr. Calvo and her collaborators reported that the 18 patients involved in the Venezuelan outbreak were critically ill, of whom 11 were pediatric, and all had central venous catheter placement. All but two of the pediatric patients were neonates, and all had serious underlying morbidities; several had significant congenital anomalies. The median patient age was 26 days (range, 2 days to 72 years), reflecting the high number of neonates affected. One of the adult patients had esophageal carcinoma. Overall, 10/18 patients (56%) had undergone surgical procedures, and all had received antibiotics.

As has been reported in other C. auris outbreaks, isolates from blood cultures of affected individuals were initially reported as C. haemulonii by the Vitek 2 C automated microbial identification system. Molecular identification was completed by sequencing the internal transcribed spacer (ITS) of the rDNA gene, with analysis aided by the National Institutes of Health’s GenBank and the Netherland’s CBS Fungal Diversity Centre , in order to confirm the identity of the fungal isolates as C. auris. Dr. Calvo and her associates were able to generate a dendrogram of the 18 isolates, showing high clonality, a trait shared with other nosocomial C. auris outbreaks.

Susceptibility testing of the C. auris cultured from blood samples of the affected patients showed that fluconazole had a minimum inhibitory concentration to inhibit the growth of 50% of the organisms (MIC₅₀₎ of greater than 64 mcg/mL. For fluconazole, the MIC₉₀, range, and geometric mean were all also above 64 mcg/mL, indicating a high level of resistance. For voriconazole, the MICs, range, and mean were all 4 mcg/mL. For amphotericin B, the MIC₅₀ was 1 mcg/mL, the MIC₉₀ was 2 mcg/mL, the range was 1-2, and the geometric mean was 1.414 mcg/mL.

The high number of pediatric patients affected, as well as early pathogen identification with speedy and appropriate antifungal therapy and prompt removal of central venous catheters, likely contributed to the relatively low 30-day crude mortality rate of 28%, said Dr. Calvo and her coauthors.

“C. auris should be considered an emergent multiresistant species,” wrote Dr. Calbo and her collaborators, noting that the opportunistic pathogen has a “high potential for nosocomial horizontal transmission.”

In June 2016, the Centers for Disease Control issued a clinical alert to U.S. healthcare facilities regarding the global emergence of invasive infections caused by C. auris.

The study authors reported no external sources of funding and no conflicts of interest.

[email protected]

On Twitter @karioakes