Jennie Smith

Two U.S. individuals who contracted Middle East Respiratory Syndrome coronavirus (MERS-CoV) did not transmit the virus to members of their households or to health care workers, officials at the Centers for Disease Control and Prevention say.

Both patients with confirmed infections, one in Florida and another in Indiana, had traveled to Saudi Arabia before becoming ill.

Polymerase chain reaction assays and serology revealed no evidence of previous or active infection in any members of their households or healthcare workers who attended them.

In a press statement June 17, Dr. David Swerdlow, who is leading the agency’s MERS-CoV response, called the negative results among contacts that the CDC considered at highest risk for MERS-CoV infection "reassuring."

While the risk MERS-CoV infection in the United States remains low, Dr. Swerdlow added, "it is important that we remain vigilant and quickly identify and respond to any additional importations."

Two U.S. individuals who contracted Middle East Respiratory Syndrome coronavirus (MERS-CoV) did not transmit the virus to members of their households or to health care workers, officials at the Centers for Disease Control and Prevention say.

Both patients with confirmed infections, one in Florida and another in Indiana, had traveled to Saudi Arabia before becoming ill.

Polymerase chain reaction assays and serology revealed no evidence of previous or active infection in any members of their households or healthcare workers who attended them.

In a press statement June 17, Dr. David Swerdlow, who is leading the agency’s MERS-CoV response, called the negative results among contacts that the CDC considered at highest risk for MERS-CoV infection "reassuring."

While the risk MERS-CoV infection in the United States remains low, Dr. Swerdlow added, "it is important that we remain vigilant and quickly identify and respond to any additional importations."

Two U.S. individuals who contracted Middle East Respiratory Syndrome coronavirus (MERS-CoV) did not transmit the virus to members of their households or to health care workers, officials at the Centers for Disease Control and Prevention say.

Both patients with confirmed infections, one in Florida and another in Indiana, had traveled to Saudi Arabia before becoming ill.

Polymerase chain reaction assays and serology revealed no evidence of previous or active infection in any members of their households or healthcare workers who attended them.

In a press statement June 17, Dr. David Swerdlow, who is leading the agency’s MERS-CoV response, called the negative results among contacts that the CDC considered at highest risk for MERS-CoV infection "reassuring."

While the risk MERS-CoV infection in the United States remains low, Dr. Swerdlow added, "it is important that we remain vigilant and quickly identify and respond to any additional importations."

The current wave of Middle East Respiratory Syndrome Coronavirus (MERS-CoV) infections is related to poor infection control in hospitals, officials of the World Health Organization said June 17.

"There is no evidence of sustained person-to-person transmission occurring in communities," Dr. Kenji Fukuda, assistant director general of WHO in Geneva, said during a press conference to disclose findings from the organization’s International Health Regulations Emergency Committee on MERS-CoV. The committee met the day before.

Courtesy of Maureen Metcalfe/Azaibi Tamin

Rather, Dr. Fukuda said, the most recent cases appear to be related to "suboptimal" infection control measures in hospitals. He stressed that the measures required for controlling MERS-CoV transmission in hospital settings were "basic" and could be implemented anywhere, regardless of resources.

"Infection control can really reduce spread in hospitals. This is a critical finding," he said.

WHO officials have reported 701 laboratory confirmed cases of MERS-CoV to date and 249 deaths worldwide. Dr. Fukuda downplayed concerns that Saudi Arabia, where the majority of MERS-CoV cases and deaths have occurred, continues to report inaccurate or out-of-date figures. Significant under-reporting of MERS-CoV cases and deaths was revealed and corrected by Saudi officials early this month, raising the number of cases there by 20%.

"Saudi Arabia is making a very strong effort to catch up," Dr. Fukuda said. "I am confident that the government has really strengthened its efforts to keep on top of the numbers."

He also said that WHO’s infection-prevention recommendations for MERS-CoV have changed to reflect the most recent findings that the virus can be directly transmitted from camels to humans.

"We have a better understanding that camels are a very important source of exposure in the community," he noted. For people working directly with camels, including veterinarians and keepers, Dr. Fukuda said, "recommended practices include leaving clothes in the workplace." Other recommendations include drinking only pasteurized milk and cooking all food thoroughly to prevent another potential source of viral contamination.

Recommendations for pilgrims to Mecca, Saudi Arabia, and for medical delegations accompanying them, "have expanded a lot since last year" to reflect what is known about transmission and exposure. Still, Dr. Fukuda said, WHO officials remain concerned that basic infection control measures be communicated and improved prior to this year’s Hajj in October.

Because so little person-to-person transmission in community settings has been reported so far, he said, "the current situation does not constitute a public health emergency of international concern."

MERS-CoV, however, remains a "serious" public health threat because of its high fatality rate and the fact that much remains unknown about how the virus is transmitted from camels to people, and a lack of understanding about the ultimate source of the virus.

"The gorilla in the room," Dr. Fukuda said, is whether the virus "has the potential to change and become much more transmissible person to person."

The current wave of Middle East Respiratory Syndrome Coronavirus (MERS-CoV) infections is related to poor infection control in hospitals, officials of the World Health Organization said June 17.

"There is no evidence of sustained person-to-person transmission occurring in communities," Dr. Kenji Fukuda, assistant director general of WHO in Geneva, said during a press conference to disclose findings from the organization’s International Health Regulations Emergency Committee on MERS-CoV. The committee met the day before.

Courtesy of Maureen Metcalfe/Azaibi Tamin

Rather, Dr. Fukuda said, the most recent cases appear to be related to "suboptimal" infection control measures in hospitals. He stressed that the measures required for controlling MERS-CoV transmission in hospital settings were "basic" and could be implemented anywhere, regardless of resources.

"Infection control can really reduce spread in hospitals. This is a critical finding," he said.

WHO officials have reported 701 laboratory confirmed cases of MERS-CoV to date and 249 deaths worldwide. Dr. Fukuda downplayed concerns that Saudi Arabia, where the majority of MERS-CoV cases and deaths have occurred, continues to report inaccurate or out-of-date figures. Significant under-reporting of MERS-CoV cases and deaths was revealed and corrected by Saudi officials early this month, raising the number of cases there by 20%.

"Saudi Arabia is making a very strong effort to catch up," Dr. Fukuda said. "I am confident that the government has really strengthened its efforts to keep on top of the numbers."

He also said that WHO’s infection-prevention recommendations for MERS-CoV have changed to reflect the most recent findings that the virus can be directly transmitted from camels to humans.

"We have a better understanding that camels are a very important source of exposure in the community," he noted. For people working directly with camels, including veterinarians and keepers, Dr. Fukuda said, "recommended practices include leaving clothes in the workplace." Other recommendations include drinking only pasteurized milk and cooking all food thoroughly to prevent another potential source of viral contamination.

Recommendations for pilgrims to Mecca, Saudi Arabia, and for medical delegations accompanying them, "have expanded a lot since last year" to reflect what is known about transmission and exposure. Still, Dr. Fukuda said, WHO officials remain concerned that basic infection control measures be communicated and improved prior to this year’s Hajj in October.

Because so little person-to-person transmission in community settings has been reported so far, he said, "the current situation does not constitute a public health emergency of international concern."

MERS-CoV, however, remains a "serious" public health threat because of its high fatality rate and the fact that much remains unknown about how the virus is transmitted from camels to people, and a lack of understanding about the ultimate source of the virus.

"The gorilla in the room," Dr. Fukuda said, is whether the virus "has the potential to change and become much more transmissible person to person."

The current wave of Middle East Respiratory Syndrome Coronavirus (MERS-CoV) infections is related to poor infection control in hospitals, officials of the World Health Organization said June 17.

"There is no evidence of sustained person-to-person transmission occurring in communities," Dr. Kenji Fukuda, assistant director general of WHO in Geneva, said during a press conference to disclose findings from the organization’s International Health Regulations Emergency Committee on MERS-CoV. The committee met the day before.

Courtesy of Maureen Metcalfe/Azaibi Tamin

Rather, Dr. Fukuda said, the most recent cases appear to be related to "suboptimal" infection control measures in hospitals. He stressed that the measures required for controlling MERS-CoV transmission in hospital settings were "basic" and could be implemented anywhere, regardless of resources.

"Infection control can really reduce spread in hospitals. This is a critical finding," he said.

WHO officials have reported 701 laboratory confirmed cases of MERS-CoV to date and 249 deaths worldwide. Dr. Fukuda downplayed concerns that Saudi Arabia, where the majority of MERS-CoV cases and deaths have occurred, continues to report inaccurate or out-of-date figures. Significant under-reporting of MERS-CoV cases and deaths was revealed and corrected by Saudi officials early this month, raising the number of cases there by 20%.

"Saudi Arabia is making a very strong effort to catch up," Dr. Fukuda said. "I am confident that the government has really strengthened its efforts to keep on top of the numbers."

He also said that WHO’s infection-prevention recommendations for MERS-CoV have changed to reflect the most recent findings that the virus can be directly transmitted from camels to humans.

"We have a better understanding that camels are a very important source of exposure in the community," he noted. For people working directly with camels, including veterinarians and keepers, Dr. Fukuda said, "recommended practices include leaving clothes in the workplace." Other recommendations include drinking only pasteurized milk and cooking all food thoroughly to prevent another potential source of viral contamination.

Recommendations for pilgrims to Mecca, Saudi Arabia, and for medical delegations accompanying them, "have expanded a lot since last year" to reflect what is known about transmission and exposure. Still, Dr. Fukuda said, WHO officials remain concerned that basic infection control measures be communicated and improved prior to this year’s Hajj in October.

Because so little person-to-person transmission in community settings has been reported so far, he said, "the current situation does not constitute a public health emergency of international concern."

MERS-CoV, however, remains a "serious" public health threat because of its high fatality rate and the fact that much remains unknown about how the virus is transmitted from camels to people, and a lack of understanding about the ultimate source of the virus.

"The gorilla in the room," Dr. Fukuda said, is whether the virus "has the potential to change and become much more transmissible person to person."

Biodegradable biolimus-eluting stents are as safe and effective as durable everolimus-eluting stents at 2 years’ follow-up, with no significant differences seen in rates of target lesion revascularization, mortality, or myocardial infarction.

The findings come from NEXT (NOBORI Biolimus-Eluting vs. XIENCE/PROMUS Everolimus-Eluting Stent Trial), a 3-year randomized trial led by Dr. Masahiro Natsuaki of Saiseikai Fukuoka (Japan) General Hospital. They were presented at the annual meeting of the American College of Cardiology and published in JAMA (doi:10.1001/jama.2014.3584).

NEXT compared the biodegradable polymer biolimus-eluting stent (BP-BES) to the durable polymer everolimus-eluting stent (DP-EES), measuring target lesion revascularization and whether BP-BES carries a risk for excess mortality or MI, compared with DP-EES, as shorter studies and meta-analyses have suggested.

Dr. Natsuaki and colleagues randomized 3,235 patients from nearly 100 treatment centers to BP-BES (n = 1,617) or DP-EES (n = 1,618), with 98% of all patients completing follow-up. Mortality and MI were comparable for both stents (7.8% for BP-BES vs. 7.7% for DP-EES; noninferiority, P = .003), and the need for target lesion revascularization was also comparable for both stents (6.2% vs. 6%; noninferiority, P less than .001). The researchers noted that "2 years is not long enough to confirm the long-term safety of BP-BES, and the study was underpowered for the interim analysis. Follow-up at 3 years will be important."

NEXT was sponsored by Terumo Japan, maker of the biodegradable stents. Two investigators disclosed they are advisers for Terumo Japan and Abbott Vascular Japan, maker of the durable polymer stents used.

Biodegradable biolimus-eluting stents are as safe and effective as durable everolimus-eluting stents at 2 years’ follow-up, with no significant differences seen in rates of target lesion revascularization, mortality, or myocardial infarction.

The findings come from NEXT (NOBORI Biolimus-Eluting vs. XIENCE/PROMUS Everolimus-Eluting Stent Trial), a 3-year randomized trial led by Dr. Masahiro Natsuaki of Saiseikai Fukuoka (Japan) General Hospital. They were presented at the annual meeting of the American College of Cardiology and published in JAMA (doi:10.1001/jama.2014.3584).

NEXT compared the biodegradable polymer biolimus-eluting stent (BP-BES) to the durable polymer everolimus-eluting stent (DP-EES), measuring target lesion revascularization and whether BP-BES carries a risk for excess mortality or MI, compared with DP-EES, as shorter studies and meta-analyses have suggested.

Dr. Natsuaki and colleagues randomized 3,235 patients from nearly 100 treatment centers to BP-BES (n = 1,617) or DP-EES (n = 1,618), with 98% of all patients completing follow-up. Mortality and MI were comparable for both stents (7.8% for BP-BES vs. 7.7% for DP-EES; noninferiority, P = .003), and the need for target lesion revascularization was also comparable for both stents (6.2% vs. 6%; noninferiority, P less than .001). The researchers noted that "2 years is not long enough to confirm the long-term safety of BP-BES, and the study was underpowered for the interim analysis. Follow-up at 3 years will be important."

NEXT was sponsored by Terumo Japan, maker of the biodegradable stents. Two investigators disclosed they are advisers for Terumo Japan and Abbott Vascular Japan, maker of the durable polymer stents used.

Biodegradable biolimus-eluting stents are as safe and effective as durable everolimus-eluting stents at 2 years’ follow-up, with no significant differences seen in rates of target lesion revascularization, mortality, or myocardial infarction.

The findings come from NEXT (NOBORI Biolimus-Eluting vs. XIENCE/PROMUS Everolimus-Eluting Stent Trial), a 3-year randomized trial led by Dr. Masahiro Natsuaki of Saiseikai Fukuoka (Japan) General Hospital. They were presented at the annual meeting of the American College of Cardiology and published in JAMA (doi:10.1001/jama.2014.3584).

NEXT compared the biodegradable polymer biolimus-eluting stent (BP-BES) to the durable polymer everolimus-eluting stent (DP-EES), measuring target lesion revascularization and whether BP-BES carries a risk for excess mortality or MI, compared with DP-EES, as shorter studies and meta-analyses have suggested.

Dr. Natsuaki and colleagues randomized 3,235 patients from nearly 100 treatment centers to BP-BES (n = 1,617) or DP-EES (n = 1,618), with 98% of all patients completing follow-up. Mortality and MI were comparable for both stents (7.8% for BP-BES vs. 7.7% for DP-EES; noninferiority, P = .003), and the need for target lesion revascularization was also comparable for both stents (6.2% vs. 6%; noninferiority, P less than .001). The researchers noted that "2 years is not long enough to confirm the long-term safety of BP-BES, and the study was underpowered for the interim analysis. Follow-up at 3 years will be important."

NEXT was sponsored by Terumo Japan, maker of the biodegradable stents. Two investigators disclosed they are advisers for Terumo Japan and Abbott Vascular Japan, maker of the durable polymer stents used.

Earn 0.25 hours AMA PRA Category 1 credit: Read this article, and click the link at the end to take the posttest.

Thanks to anti–tumor necrosis factor inhibitors and other highly effective biologic therapies, rheumatologists are increasingly embracing treat to target, a strategy in which patients are closely monitored and medications adjusted until a patient has the least disease activity possible.

Ample evidence from randomized, controlled trials has shown treat to target – sometimes referred to as tight control – to result in better outcomes than standard therapy in rheumatoid arthritis patients.

But in psoriatic arthritis (PsA), a more heterogeneous disorder with skin and nail manifestations as well as joint and connective tissue involvement, remission has historically been less well defined. Only in recent years have endpoints been developed and validated for minimal disease activity in PsA, and evidence in support of a treat-to-target approach is now slowly trickling in.

Mary Jo M. Dales/Frontline Medical News

At the annual European Congress of Rheumatology, Dr. Arthur Kavanaugh of the University of California, San Diego, presented results from a 5-year extension of a randomized, controlled trial of golimumab in patients with PsA that showed better long-term outcomes in those able to achieve minimal disease activity (MDA) through a treat-to-target strategy.

"I think [the study] does provide some evidence suggesting that treat to target could well be a valuable goal for PsA, Dr. Kavanaugh said. "Right now, RA has the advantage of more studies showing this."

Dr. Kavanaugh and his colleagues’ study used data from an open-label extension of a clinical trial in which about 400 patients were randomized to receive golimumab at 50 mg or 100 mg, or placebo; all placebo patients were crossed over to golimumab treatment at 24 weeks and during the long-term, open-label extension of the trial, were followed for as long as 252 weeks. Patients were assessed at 14, 24, and 52 weeks, then yearly until week 252. The investigators used a validated composite endpoint that included measures of skin, joint, and enthesis involvement.

About half of the patients (44.2% of those randomized to placebo and 51.7% of those randomized to active treatment) achieved persistent MDA over three or more consecutive time points during follow-up, and investigators saw significantly better clinically meaningful Health Assessment Questionnaire improvement and less radiographic progression in patients who had achieved MDA, regardless of treatment allocation.

Patients who achieved MDA after crossing over had improvements that were similar to those who started on golimumab at baseline, suggesting that delayed treatment initiation does not result in a worsening of physical function or radiographic progression.

"When it comes to patients, we cannot always control when we will see them in the course of disease," Dr. Kavanaugh said. "These data suggest that even though a patient may show up with months of uncontrolled disease, it is still a viable goal to treat them to try to get MDA."

Dr. Kavanaugh said that further studies in PsA patients were needed to confirm that treat-to-target strategies resulted in better long-term disease outcomes. "As always in medicine, it is important to have verification from multiple studies. It would be helpful to have data from studies using medications with other mechanisms of action to support treat to target," he added.

Dr. Kavanaugh disclosed research and grant support from Abbott, Amgen, Janssen, and UCB. His coauthors on the study disclosed financial support from additional manufacturers, and three were employees of Janssen.

To earn 0.25 hours AMA PRA Category 1 credit after reading this article, take the post-test here.

Earn 0.25 hours AMA PRA Category 1 credit: Read this article, and click the link at the end to take the posttest.

Thanks to anti–tumor necrosis factor inhibitors and other highly effective biologic therapies, rheumatologists are increasingly embracing treat to target, a strategy in which patients are closely monitored and medications adjusted until a patient has the least disease activity possible.

Ample evidence from randomized, controlled trials has shown treat to target – sometimes referred to as tight control – to result in better outcomes than standard therapy in rheumatoid arthritis patients.

But in psoriatic arthritis (PsA), a more heterogeneous disorder with skin and nail manifestations as well as joint and connective tissue involvement, remission has historically been less well defined. Only in recent years have endpoints been developed and validated for minimal disease activity in PsA, and evidence in support of a treat-to-target approach is now slowly trickling in.

Mary Jo M. Dales/Frontline Medical News

At the annual European Congress of Rheumatology, Dr. Arthur Kavanaugh of the University of California, San Diego, presented results from a 5-year extension of a randomized, controlled trial of golimumab in patients with PsA that showed better long-term outcomes in those able to achieve minimal disease activity (MDA) through a treat-to-target strategy.

"I think [the study] does provide some evidence suggesting that treat to target could well be a valuable goal for PsA, Dr. Kavanaugh said. "Right now, RA has the advantage of more studies showing this."

Dr. Kavanaugh and his colleagues’ study used data from an open-label extension of a clinical trial in which about 400 patients were randomized to receive golimumab at 50 mg or 100 mg, or placebo; all placebo patients were crossed over to golimumab treatment at 24 weeks and during the long-term, open-label extension of the trial, were followed for as long as 252 weeks. Patients were assessed at 14, 24, and 52 weeks, then yearly until week 252. The investigators used a validated composite endpoint that included measures of skin, joint, and enthesis involvement.

About half of the patients (44.2% of those randomized to placebo and 51.7% of those randomized to active treatment) achieved persistent MDA over three or more consecutive time points during follow-up, and investigators saw significantly better clinically meaningful Health Assessment Questionnaire improvement and less radiographic progression in patients who had achieved MDA, regardless of treatment allocation.

Patients who achieved MDA after crossing over had improvements that were similar to those who started on golimumab at baseline, suggesting that delayed treatment initiation does not result in a worsening of physical function or radiographic progression.

"When it comes to patients, we cannot always control when we will see them in the course of disease," Dr. Kavanaugh said. "These data suggest that even though a patient may show up with months of uncontrolled disease, it is still a viable goal to treat them to try to get MDA."

Dr. Kavanaugh said that further studies in PsA patients were needed to confirm that treat-to-target strategies resulted in better long-term disease outcomes. "As always in medicine, it is important to have verification from multiple studies. It would be helpful to have data from studies using medications with other mechanisms of action to support treat to target," he added.

Dr. Kavanaugh disclosed research and grant support from Abbott, Amgen, Janssen, and UCB. His coauthors on the study disclosed financial support from additional manufacturers, and three were employees of Janssen.

To earn 0.25 hours AMA PRA Category 1 credit after reading this article, take the post-test here.

Earn 0.25 hours AMA PRA Category 1 credit: Read this article, and click the link at the end to take the posttest.

Thanks to anti–tumor necrosis factor inhibitors and other highly effective biologic therapies, rheumatologists are increasingly embracing treat to target, a strategy in which patients are closely monitored and medications adjusted until a patient has the least disease activity possible.

Ample evidence from randomized, controlled trials has shown treat to target – sometimes referred to as tight control – to result in better outcomes than standard therapy in rheumatoid arthritis patients.

But in psoriatic arthritis (PsA), a more heterogeneous disorder with skin and nail manifestations as well as joint and connective tissue involvement, remission has historically been less well defined. Only in recent years have endpoints been developed and validated for minimal disease activity in PsA, and evidence in support of a treat-to-target approach is now slowly trickling in.

Mary Jo M. Dales/Frontline Medical News

At the annual European Congress of Rheumatology, Dr. Arthur Kavanaugh of the University of California, San Diego, presented results from a 5-year extension of a randomized, controlled trial of golimumab in patients with PsA that showed better long-term outcomes in those able to achieve minimal disease activity (MDA) through a treat-to-target strategy.

"I think [the study] does provide some evidence suggesting that treat to target could well be a valuable goal for PsA, Dr. Kavanaugh said. "Right now, RA has the advantage of more studies showing this."

Dr. Kavanaugh and his colleagues’ study used data from an open-label extension of a clinical trial in which about 400 patients were randomized to receive golimumab at 50 mg or 100 mg, or placebo; all placebo patients were crossed over to golimumab treatment at 24 weeks and during the long-term, open-label extension of the trial, were followed for as long as 252 weeks. Patients were assessed at 14, 24, and 52 weeks, then yearly until week 252. The investigators used a validated composite endpoint that included measures of skin, joint, and enthesis involvement.

About half of the patients (44.2% of those randomized to placebo and 51.7% of those randomized to active treatment) achieved persistent MDA over three or more consecutive time points during follow-up, and investigators saw significantly better clinically meaningful Health Assessment Questionnaire improvement and less radiographic progression in patients who had achieved MDA, regardless of treatment allocation.

Patients who achieved MDA after crossing over had improvements that were similar to those who started on golimumab at baseline, suggesting that delayed treatment initiation does not result in a worsening of physical function or radiographic progression.

"When it comes to patients, we cannot always control when we will see them in the course of disease," Dr. Kavanaugh said. "These data suggest that even though a patient may show up with months of uncontrolled disease, it is still a viable goal to treat them to try to get MDA."

Dr. Kavanaugh said that further studies in PsA patients were needed to confirm that treat-to-target strategies resulted in better long-term disease outcomes. "As always in medicine, it is important to have verification from multiple studies. It would be helpful to have data from studies using medications with other mechanisms of action to support treat to target," he added.

Dr. Kavanaugh disclosed research and grant support from Abbott, Amgen, Janssen, and UCB. His coauthors on the study disclosed financial support from additional manufacturers, and three were employees of Janssen.

To earn 0.25 hours AMA PRA Category 1 credit after reading this article, take the post-test here.

Thanks to anti–tumor necrosis factor inhibitors and other highly effective biologic therapies, rheumatologists are increasingly embracing treat to target, a strategy in which patients are closely monitored and medications adjusted until a patient has the least disease activity possible.

Ample evidence from randomized, controlled trials has shown treat to target – sometimes referred to as tight control – to result in better outcomes than standard therapy in rheumatoid arthritis patients.

But in psoriatic arthritis (PsA), a more heterogeneous disorder with skin and nail manifestations as well as joint and connective tissue involvement, remission has historically been less well defined. Only in recent years have endpoints been developed and validated for minimal disease activity in PsA, and evidence in support of a treat-to-target approach is now slowly trickling in.

Mary Jo M. Dales/Frontline Medical News

At the annual European Congress of Rheumatology, Dr. Arthur Kavanaugh of the University of California, San Diego, presented results from a 5-year extension of a randomized, controlled trial of golimumab in patients with PsA that showed better long-term outcomes in those able to achieve minimal disease activity (MDA) through a treat-to-target strategy.

"I think [the study] does provide some evidence suggesting that treat to target could well be a valuable goal for PsA, Dr. Kavanaugh said. "Right now, RA has the advantage of more studies showing this."

Dr. Kavanaugh and his colleagues’ study used data from an open-label extension of a clinical trial in which about 400 patients were randomized to receive golimumab at 50 mg or 100 mg, or placebo; all placebo patients were crossed over to golimumab treatment at 24 weeks and during the long-term, open-label extension of the trial, were followed for as long as 252 weeks. Patients were assessed at 14, 24, and 52 weeks, then yearly until week 252. The investigators used a validated composite endpoint that included measures of skin, joint, and enthesis involvement.

About half of the patients (44.2% of those randomized to placebo and 51.7% of those randomized to active treatment) achieved persistent MDA over three or more consecutive time points during follow-up, and investigators saw significantly better clinically meaningful Health Assessment Questionnaire improvement and less radiographic progression in patients who had achieved MDA, regardless of treatment allocation.

Patients who achieved MDA after crossing over had improvements that were similar to those who started on golimumab at baseline, suggesting that delayed treatment initiation does not result in a worsening of physical function or radiographic progression.

"When it comes to patients, we cannot always control when we will see them in the course of disease," Dr. Kavanaugh said. "These data suggest that even though a patient may show up with months of uncontrolled disease, it is still a viable goal to treat them to try to get MDA."

Dr. Kavanaugh said that further studies in PsA patients were needed to confirm that treat-to-target strategies resulted in better long-term disease outcomes. "As always in medicine, it is important to have verification from multiple studies. It would be helpful to have data from studies using medications with other mechanisms of action to support treat to target," he added.

Dr. Kavanaugh disclosed research and grant support from Abbott, Amgen, Janssen, and UCB. His coauthors on the study disclosed financial support from additional manufacturers, and three were employees of Janssen.

Thanks to anti–tumor necrosis factor inhibitors and other highly effective biologic therapies, rheumatologists are increasingly embracing treat to target, a strategy in which patients are closely monitored and medications adjusted until a patient has the least disease activity possible.

Ample evidence from randomized, controlled trials has shown treat to target – sometimes referred to as tight control – to result in better outcomes than standard therapy in rheumatoid arthritis patients.

But in psoriatic arthritis (PsA), a more heterogeneous disorder with skin and nail manifestations as well as joint and connective tissue involvement, remission has historically been less well defined. Only in recent years have endpoints been developed and validated for minimal disease activity in PsA, and evidence in support of a treat-to-target approach is now slowly trickling in.

Mary Jo M. Dales/Frontline Medical News

At the annual European Congress of Rheumatology, Dr. Arthur Kavanaugh of the University of California, San Diego, presented results from a 5-year extension of a randomized, controlled trial of golimumab in patients with PsA that showed better long-term outcomes in those able to achieve minimal disease activity (MDA) through a treat-to-target strategy.

"I think [the study] does provide some evidence suggesting that treat to target could well be a valuable goal for PsA, Dr. Kavanaugh said. "Right now, RA has the advantage of more studies showing this."

Dr. Kavanaugh and his colleagues’ study used data from an open-label extension of a clinical trial in which about 400 patients were randomized to receive golimumab at 50 mg or 100 mg, or placebo; all placebo patients were crossed over to golimumab treatment at 24 weeks and during the long-term, open-label extension of the trial, were followed for as long as 252 weeks. Patients were assessed at 14, 24, and 52 weeks, then yearly until week 252. The investigators used a validated composite endpoint that included measures of skin, joint, and enthesis involvement.

About half of the patients (44.2% of those randomized to placebo and 51.7% of those randomized to active treatment) achieved persistent MDA over three or more consecutive time points during follow-up, and investigators saw significantly better clinically meaningful Health Assessment Questionnaire improvement and less radiographic progression in patients who had achieved MDA, regardless of treatment allocation.

Patients who achieved MDA after crossing over had improvements that were similar to those who started on golimumab at baseline, suggesting that delayed treatment initiation does not result in a worsening of physical function or radiographic progression.

"When it comes to patients, we cannot always control when we will see them in the course of disease," Dr. Kavanaugh said. "These data suggest that even though a patient may show up with months of uncontrolled disease, it is still a viable goal to treat them to try to get MDA."

Dr. Kavanaugh said that further studies in PsA patients were needed to confirm that treat-to-target strategies resulted in better long-term disease outcomes. "As always in medicine, it is important to have verification from multiple studies. It would be helpful to have data from studies using medications with other mechanisms of action to support treat to target," he added.

Dr. Kavanaugh disclosed research and grant support from Abbott, Amgen, Janssen, and UCB. His coauthors on the study disclosed financial support from additional manufacturers, and three were employees of Janssen.

Thanks to anti–tumor necrosis factor inhibitors and other highly effective biologic therapies, rheumatologists are increasingly embracing treat to target, a strategy in which patients are closely monitored and medications adjusted until a patient has the least disease activity possible.

Ample evidence from randomized, controlled trials has shown treat to target – sometimes referred to as tight control – to result in better outcomes than standard therapy in rheumatoid arthritis patients.

But in psoriatic arthritis (PsA), a more heterogeneous disorder with skin and nail manifestations as well as joint and connective tissue involvement, remission has historically been less well defined. Only in recent years have endpoints been developed and validated for minimal disease activity in PsA, and evidence in support of a treat-to-target approach is now slowly trickling in.

Mary Jo M. Dales/Frontline Medical News

At the annual European Congress of Rheumatology, Dr. Arthur Kavanaugh of the University of California, San Diego, presented results from a 5-year extension of a randomized, controlled trial of golimumab in patients with PsA that showed better long-term outcomes in those able to achieve minimal disease activity (MDA) through a treat-to-target strategy.

"I think [the study] does provide some evidence suggesting that treat to target could well be a valuable goal for PsA, Dr. Kavanaugh said. "Right now, RA has the advantage of more studies showing this."

Dr. Kavanaugh and his colleagues’ study used data from an open-label extension of a clinical trial in which about 400 patients were randomized to receive golimumab at 50 mg or 100 mg, or placebo; all placebo patients were crossed over to golimumab treatment at 24 weeks and during the long-term, open-label extension of the trial, were followed for as long as 252 weeks. Patients were assessed at 14, 24, and 52 weeks, then yearly until week 252. The investigators used a validated composite endpoint that included measures of skin, joint, and enthesis involvement.

About half of the patients (44.2% of those randomized to placebo and 51.7% of those randomized to active treatment) achieved persistent MDA over three or more consecutive time points during follow-up, and investigators saw significantly better clinically meaningful Health Assessment Questionnaire improvement and less radiographic progression in patients who had achieved MDA, regardless of treatment allocation.

Patients who achieved MDA after crossing over had improvements that were similar to those who started on golimumab at baseline, suggesting that delayed treatment initiation does not result in a worsening of physical function or radiographic progression.

"When it comes to patients, we cannot always control when we will see them in the course of disease," Dr. Kavanaugh said. "These data suggest that even though a patient may show up with months of uncontrolled disease, it is still a viable goal to treat them to try to get MDA."

Dr. Kavanaugh said that further studies in PsA patients were needed to confirm that treat-to-target strategies resulted in better long-term disease outcomes. "As always in medicine, it is important to have verification from multiple studies. It would be helpful to have data from studies using medications with other mechanisms of action to support treat to target," he added.

Dr. Kavanaugh disclosed research and grant support from Abbott, Amgen, Janssen, and UCB. His coauthors on the study disclosed financial support from additional manufacturers, and three were employees of Janssen.

A case report on a camel-to-human transmission of Middle East respiratory syndrome coronavirus (MERS-CoV) offers the first conclusive evidence that the virus can be transmitted directly from camels to humans.

The report, published online June 4 in the New England Journal of Medicine (doi:10.1056/NEJMoa1401505) by Esam I. Azhar, Ph.D. and his colleagues at King Abdulaziz University Hospital, in Jeddah, Saudi Arabia, describes a 44-year old Saudi man who, in late October 2013, had applied medicine to the nasal passage of a camel with rhinorrhea.

© Rhombur/Thinkstock

After becoming ill with respiratory symptoms a week later, he was hospitalized, and investigators visited his stables to collect nasal fluid and blood samples from his animals. Nasal swabs revealed active MERS-CoV infection in one of the nine camels the man owned, and serologic samples from other camels in his herd showed evidence of recent prior infection, at a time when serum screening by immunofluorescence assay had yet to reveal MERS-CoV antibodies in the patient. This meant, the researchers noted, that the camels had been infected before the patient.

Using nasal swab samples, Dr. Azhar and his colleagues carried out reverse-transcriptase–polymerase-chain-reaction detection, isolation, and sequencing of MERS-CoV from the camel with active infection and the patient. Viral isolates from both camel and human were shown to be identical on genetic sequencing. Previously, antibodies cross-reactive to MERS-CoV had been identified in camels, but without isolation and comparison of virus from both animal and human, the camels’ role as reservoirs or intermediate hosts for transmitting the virus to humans could not be confirmed.

In this case, Dr. Azhar and his colleagues wrote in their analysis, "direct cross-species transmission had probably occurred between the two without any intermediate host." The patient died after 2 weeks’ hospitalization, but all of his animals appeared to have cleared the virus following acute infection, suggesting that camels act only as transient hosts of the virus. "The exact reservoir that maintains the virus in its ecologic niche has yet to be identified," the investigators wrote.

None of the study’s authors reported conflicts of interest.

A case report on a camel-to-human transmission of Middle East respiratory syndrome coronavirus (MERS-CoV) offers the first conclusive evidence that the virus can be transmitted directly from camels to humans.

The report, published online June 4 in the New England Journal of Medicine (doi:10.1056/NEJMoa1401505) by Esam I. Azhar, Ph.D. and his colleagues at King Abdulaziz University Hospital, in Jeddah, Saudi Arabia, describes a 44-year old Saudi man who, in late October 2013, had applied medicine to the nasal passage of a camel with rhinorrhea.

© Rhombur/Thinkstock

After becoming ill with respiratory symptoms a week later, he was hospitalized, and investigators visited his stables to collect nasal fluid and blood samples from his animals. Nasal swabs revealed active MERS-CoV infection in one of the nine camels the man owned, and serologic samples from other camels in his herd showed evidence of recent prior infection, at a time when serum screening by immunofluorescence assay had yet to reveal MERS-CoV antibodies in the patient. This meant, the researchers noted, that the camels had been infected before the patient.

Using nasal swab samples, Dr. Azhar and his colleagues carried out reverse-transcriptase–polymerase-chain-reaction detection, isolation, and sequencing of MERS-CoV from the camel with active infection and the patient. Viral isolates from both camel and human were shown to be identical on genetic sequencing. Previously, antibodies cross-reactive to MERS-CoV had been identified in camels, but without isolation and comparison of virus from both animal and human, the camels’ role as reservoirs or intermediate hosts for transmitting the virus to humans could not be confirmed.

In this case, Dr. Azhar and his colleagues wrote in their analysis, "direct cross-species transmission had probably occurred between the two without any intermediate host." The patient died after 2 weeks’ hospitalization, but all of his animals appeared to have cleared the virus following acute infection, suggesting that camels act only as transient hosts of the virus. "The exact reservoir that maintains the virus in its ecologic niche has yet to be identified," the investigators wrote.

None of the study’s authors reported conflicts of interest.

A case report on a camel-to-human transmission of Middle East respiratory syndrome coronavirus (MERS-CoV) offers the first conclusive evidence that the virus can be transmitted directly from camels to humans.

The report, published online June 4 in the New England Journal of Medicine (doi:10.1056/NEJMoa1401505) by Esam I. Azhar, Ph.D. and his colleagues at King Abdulaziz University Hospital, in Jeddah, Saudi Arabia, describes a 44-year old Saudi man who, in late October 2013, had applied medicine to the nasal passage of a camel with rhinorrhea.

© Rhombur/Thinkstock

After becoming ill with respiratory symptoms a week later, he was hospitalized, and investigators visited his stables to collect nasal fluid and blood samples from his animals. Nasal swabs revealed active MERS-CoV infection in one of the nine camels the man owned, and serologic samples from other camels in his herd showed evidence of recent prior infection, at a time when serum screening by immunofluorescence assay had yet to reveal MERS-CoV antibodies in the patient. This meant, the researchers noted, that the camels had been infected before the patient.

Using nasal swab samples, Dr. Azhar and his colleagues carried out reverse-transcriptase–polymerase-chain-reaction detection, isolation, and sequencing of MERS-CoV from the camel with active infection and the patient. Viral isolates from both camel and human were shown to be identical on genetic sequencing. Previously, antibodies cross-reactive to MERS-CoV had been identified in camels, but without isolation and comparison of virus from both animal and human, the camels’ role as reservoirs or intermediate hosts for transmitting the virus to humans could not be confirmed.

In this case, Dr. Azhar and his colleagues wrote in their analysis, "direct cross-species transmission had probably occurred between the two without any intermediate host." The patient died after 2 weeks’ hospitalization, but all of his animals appeared to have cleared the virus following acute infection, suggesting that camels act only as transient hosts of the virus. "The exact reservoir that maintains the virus in its ecologic niche has yet to be identified," the investigators wrote.

None of the study’s authors reported conflicts of interest.

An Indiana man infected with Middle East Respiratory Syndrome Coronavirus had not transmitted the virus to a colleague in Illinois, as was previously suspected, Centers for Disease Control and Prevention officials said May 28.

On May 17, the CDC disclosed that the Illinois resident, who had attended an extended business meeting with the confirmed Indiana MERS-CoV patient prior to that patient’s hospitalization, had tested positive for MERS-CoV antibodies on serological assays. The case was particularly worrisome because it suggested transmission through a more casual level of contact than has been seen in most MERS cases to date.

Courtesy of Cynthia Goldsmith/Azaibi Tamin

However, CDC officials now say that additional testing with a neutralizing antibody assay, a more definitive blood test that takes 5 or more days to produce results, revealed that the Illinois man had not been infected with MERS-CoV.

Thus far only two U.S. residents have been confirmed with MERS-CoV, the Indiana patient and a Florida patient. Both became ill after travel to Saudi Arabia. None of their stateside contacts has yet tested positive, though voluntary testing of family members, colleagues, fellow passengers on flights, and attending health care workers continues.

In a news conference May 28, Mark Pallansch, Ph.D., director of CDC’s Division of Viral Diseases at the National Center for Immunization and Respiratory Diseases, acknowledged that the two serological assays used in preliminary testing – the enzyme-linked immunosorbent assay (ELISA) and the immunofluorescent assay (IFA), have high specificity in excluding infection, but can result in false positives.

In the case of the Illinois resident, "there are several potential explanations for our preliminary results – that is still something not completely understood," Dr. Pallansch said. The most common and likely explanation, he said, is some cross-reactivity with another type of coronavirus.

Dr. Pallansch said that CDC would continue its protocol of using ELISA and IFA, with any positive results followed by the neutralizing antibody assay.

The neutralizing antibody assay, he said, uses live MERS-CoV and must be conducted in a high-containment lab, making it difficult to test hundreds of samples; thus initial screening with the other assays would continue.

Various serology assays are being developed around the world, including by the CDC, that may supplant the assays currently being used in the initial serological detection of MERS-CoV, Dr. Pallansch reported.

Dr. David Swerdlow, who is leading CDC’s MERS-CoV response, said during the press conference that the CDC would continue to maintain its high level of vigilance, which includes disclosing to the public any initial positive results pending confirmation, and asking individuals who test positive on first assays to take significant measures to avoid contacts that could result in transmission.

Before definitive serological results were returned, the Illinois man was asked to wear a mask, to avoid close contact with other people, and to not come in contact with crowds. He was fully compliant with those requests, Dr. Swerdlow said.

"We can’t have all the tests back in order to take public health action," Dr. Swerdlow said, noting that MERS-CoV has been seen associated with a 30% fatality rate.

"It’s our priority to make sure the public is protected," he added. While there have been only two imported cases to date in the United States, and no infections yet found to have occurred as a result of local transmission, MERS-CoV "can and likely will enter our country again."

An Indiana man infected with Middle East Respiratory Syndrome Coronavirus had not transmitted the virus to a colleague in Illinois, as was previously suspected, Centers for Disease Control and Prevention officials said May 28.

On May 17, the CDC disclosed that the Illinois resident, who had attended an extended business meeting with the confirmed Indiana MERS-CoV patient prior to that patient’s hospitalization, had tested positive for MERS-CoV antibodies on serological assays. The case was particularly worrisome because it suggested transmission through a more casual level of contact than has been seen in most MERS cases to date.

Courtesy of Cynthia Goldsmith/Azaibi Tamin

However, CDC officials now say that additional testing with a neutralizing antibody assay, a more definitive blood test that takes 5 or more days to produce results, revealed that the Illinois man had not been infected with MERS-CoV.

Thus far only two U.S. residents have been confirmed with MERS-CoV, the Indiana patient and a Florida patient. Both became ill after travel to Saudi Arabia. None of their stateside contacts has yet tested positive, though voluntary testing of family members, colleagues, fellow passengers on flights, and attending health care workers continues.

In a news conference May 28, Mark Pallansch, Ph.D., director of CDC’s Division of Viral Diseases at the National Center for Immunization and Respiratory Diseases, acknowledged that the two serological assays used in preliminary testing – the enzyme-linked immunosorbent assay (ELISA) and the immunofluorescent assay (IFA), have high specificity in excluding infection, but can result in false positives.

In the case of the Illinois resident, "there are several potential explanations for our preliminary results – that is still something not completely understood," Dr. Pallansch said. The most common and likely explanation, he said, is some cross-reactivity with another type of coronavirus.

Dr. Pallansch said that CDC would continue its protocol of using ELISA and IFA, with any positive results followed by the neutralizing antibody assay.

The neutralizing antibody assay, he said, uses live MERS-CoV and must be conducted in a high-containment lab, making it difficult to test hundreds of samples; thus initial screening with the other assays would continue.

Various serology assays are being developed around the world, including by the CDC, that may supplant the assays currently being used in the initial serological detection of MERS-CoV, Dr. Pallansch reported.

Dr. David Swerdlow, who is leading CDC’s MERS-CoV response, said during the press conference that the CDC would continue to maintain its high level of vigilance, which includes disclosing to the public any initial positive results pending confirmation, and asking individuals who test positive on first assays to take significant measures to avoid contacts that could result in transmission.

Before definitive serological results were returned, the Illinois man was asked to wear a mask, to avoid close contact with other people, and to not come in contact with crowds. He was fully compliant with those requests, Dr. Swerdlow said.

"We can’t have all the tests back in order to take public health action," Dr. Swerdlow said, noting that MERS-CoV has been seen associated with a 30% fatality rate.

"It’s our priority to make sure the public is protected," he added. While there have been only two imported cases to date in the United States, and no infections yet found to have occurred as a result of local transmission, MERS-CoV "can and likely will enter our country again."

An Indiana man infected with Middle East Respiratory Syndrome Coronavirus had not transmitted the virus to a colleague in Illinois, as was previously suspected, Centers for Disease Control and Prevention officials said May 28.

On May 17, the CDC disclosed that the Illinois resident, who had attended an extended business meeting with the confirmed Indiana MERS-CoV patient prior to that patient’s hospitalization, had tested positive for MERS-CoV antibodies on serological assays. The case was particularly worrisome because it suggested transmission through a more casual level of contact than has been seen in most MERS cases to date.

Courtesy of Cynthia Goldsmith/Azaibi Tamin

However, CDC officials now say that additional testing with a neutralizing antibody assay, a more definitive blood test that takes 5 or more days to produce results, revealed that the Illinois man had not been infected with MERS-CoV.

Thus far only two U.S. residents have been confirmed with MERS-CoV, the Indiana patient and a Florida patient. Both became ill after travel to Saudi Arabia. None of their stateside contacts has yet tested positive, though voluntary testing of family members, colleagues, fellow passengers on flights, and attending health care workers continues.

In a news conference May 28, Mark Pallansch, Ph.D., director of CDC’s Division of Viral Diseases at the National Center for Immunization and Respiratory Diseases, acknowledged that the two serological assays used in preliminary testing – the enzyme-linked immunosorbent assay (ELISA) and the immunofluorescent assay (IFA), have high specificity in excluding infection, but can result in false positives.

In the case of the Illinois resident, "there are several potential explanations for our preliminary results – that is still something not completely understood," Dr. Pallansch said. The most common and likely explanation, he said, is some cross-reactivity with another type of coronavirus.

Dr. Pallansch said that CDC would continue its protocol of using ELISA and IFA, with any positive results followed by the neutralizing antibody assay.

The neutralizing antibody assay, he said, uses live MERS-CoV and must be conducted in a high-containment lab, making it difficult to test hundreds of samples; thus initial screening with the other assays would continue.

Various serology assays are being developed around the world, including by the CDC, that may supplant the assays currently being used in the initial serological detection of MERS-CoV, Dr. Pallansch reported.

Dr. David Swerdlow, who is leading CDC’s MERS-CoV response, said during the press conference that the CDC would continue to maintain its high level of vigilance, which includes disclosing to the public any initial positive results pending confirmation, and asking individuals who test positive on first assays to take significant measures to avoid contacts that could result in transmission.

Before definitive serological results were returned, the Illinois man was asked to wear a mask, to avoid close contact with other people, and to not come in contact with crowds. He was fully compliant with those requests, Dr. Swerdlow said.

"We can’t have all the tests back in order to take public health action," Dr. Swerdlow said, noting that MERS-CoV has been seen associated with a 30% fatality rate.

"It’s our priority to make sure the public is protected," he added. While there have been only two imported cases to date in the United States, and no infections yet found to have occurred as a result of local transmission, MERS-CoV "can and likely will enter our country again."

Fracture risk in women who discontinue therapy with bisphosphonates can be assessed by measuring bone mineral density at the time of discontinuation, but subsequent frequent monitoring appears to have little predictive value, according to researchers.

The findings were published online May 5 in JAMA Internal Medicine (doi:10.1001/jamainternmed.2014.1232).

Dr. Douglas Bauer of the University of California, San Francisco, and his colleagues looked at data from a trial of about 1,000 postmenopausal women aged 61-86 who had been treated for 4-5 years with alendronate and were randomized to an additional 5 years of alendronate treatment or placebo.

Among the 437 women assigned to placebo, 22% (n = 94) experienced one or more fractures during follow-up. Hip and neck BMD were assessed via dual-energy x-ray absorptiometry (DXA) at baseline and at 1 and 3 years, and bone turnover markers (BTMs) were also analyzed.

Neither 1-year changes in hip DXA nor 1- or 3-year changes in BTM levels were associated with fracture risk. Only age and lower hip BMD at the time of treatment discontinuation were significantly predictive of fracture, according to Dr. Bauer and his associates.

The relative hazard ratio was 1.87 (95% confidence interval, 1.20-2.92) for fracture risk in lowest tertile of baseline hip BMD, and 1.54 (95% CI, 1.26-1.85) per 5-year increase in age.

Yearly monitoring – recommended by many experts after discontinuation of bisphosphonates – should not be considered predictive of fractures, the researchers noted. It was "somewhat surprising that short-term changes in these individual measurements are not associated with fracture risk after discontinuation," they wrote.

The researchers cautioned clinicians and patients contemplating a drug holiday after 5 years of treatment to "be aware that short-term monitoring to detect individuals at higher risk who might resume bisphosphonate therapy, or initiate another therapy, may not add to risk prediction over and above age and BMD measured at the time of discontinuation."

The study’s limitations include its relatively small number of fractures observed, reducing its statistical power, and the use of a single bisphosphonate medication, Dr. Bauer acknowledged.

The researchers received no outside funding, though their findings were derived from an analysis of the placebo group of the FLEX trial, a manufacturer-sponsored study comparing extended alendronate sodium treatment with placebo in a large cohort of women treated 5 years on alendronate (JAMA 2006;296:2927-38).

Dr. Bauer reported no conflicts of interest related to the study; other study authors disclosed financial relationships with Amgen, GlaxoSmithKline, Merck, Novartis, Nycomed, and Eli Lilly.

Fracture risk in women who discontinue therapy with bisphosphonates can be assessed by measuring bone mineral density at the time of discontinuation, but subsequent frequent monitoring appears to have little predictive value, according to researchers.

The findings were published online May 5 in JAMA Internal Medicine (doi:10.1001/jamainternmed.2014.1232).

Dr. Douglas Bauer of the University of California, San Francisco, and his colleagues looked at data from a trial of about 1,000 postmenopausal women aged 61-86 who had been treated for 4-5 years with alendronate and were randomized to an additional 5 years of alendronate treatment or placebo.

Among the 437 women assigned to placebo, 22% (n = 94) experienced one or more fractures during follow-up. Hip and neck BMD were assessed via dual-energy x-ray absorptiometry (DXA) at baseline and at 1 and 3 years, and bone turnover markers (BTMs) were also analyzed.

Neither 1-year changes in hip DXA nor 1- or 3-year changes in BTM levels were associated with fracture risk. Only age and lower hip BMD at the time of treatment discontinuation were significantly predictive of fracture, according to Dr. Bauer and his associates.

The relative hazard ratio was 1.87 (95% confidence interval, 1.20-2.92) for fracture risk in lowest tertile of baseline hip BMD, and 1.54 (95% CI, 1.26-1.85) per 5-year increase in age.

Yearly monitoring – recommended by many experts after discontinuation of bisphosphonates – should not be considered predictive of fractures, the researchers noted. It was "somewhat surprising that short-term changes in these individual measurements are not associated with fracture risk after discontinuation," they wrote.

The researchers cautioned clinicians and patients contemplating a drug holiday after 5 years of treatment to "be aware that short-term monitoring to detect individuals at higher risk who might resume bisphosphonate therapy, or initiate another therapy, may not add to risk prediction over and above age and BMD measured at the time of discontinuation."

The study’s limitations include its relatively small number of fractures observed, reducing its statistical power, and the use of a single bisphosphonate medication, Dr. Bauer acknowledged.

The researchers received no outside funding, though their findings were derived from an analysis of the placebo group of the FLEX trial, a manufacturer-sponsored study comparing extended alendronate sodium treatment with placebo in a large cohort of women treated 5 years on alendronate (JAMA 2006;296:2927-38).

Dr. Bauer reported no conflicts of interest related to the study; other study authors disclosed financial relationships with Amgen, GlaxoSmithKline, Merck, Novartis, Nycomed, and Eli Lilly.

Fracture risk in women who discontinue therapy with bisphosphonates can be assessed by measuring bone mineral density at the time of discontinuation, but subsequent frequent monitoring appears to have little predictive value, according to researchers.

The findings were published online May 5 in JAMA Internal Medicine (doi:10.1001/jamainternmed.2014.1232).

Dr. Douglas Bauer of the University of California, San Francisco, and his colleagues looked at data from a trial of about 1,000 postmenopausal women aged 61-86 who had been treated for 4-5 years with alendronate and were randomized to an additional 5 years of alendronate treatment or placebo.

Among the 437 women assigned to placebo, 22% (n = 94) experienced one or more fractures during follow-up. Hip and neck BMD were assessed via dual-energy x-ray absorptiometry (DXA) at baseline and at 1 and 3 years, and bone turnover markers (BTMs) were also analyzed.

Neither 1-year changes in hip DXA nor 1- or 3-year changes in BTM levels were associated with fracture risk. Only age and lower hip BMD at the time of treatment discontinuation were significantly predictive of fracture, according to Dr. Bauer and his associates.

The relative hazard ratio was 1.87 (95% confidence interval, 1.20-2.92) for fracture risk in lowest tertile of baseline hip BMD, and 1.54 (95% CI, 1.26-1.85) per 5-year increase in age.

Yearly monitoring – recommended by many experts after discontinuation of bisphosphonates – should not be considered predictive of fractures, the researchers noted. It was "somewhat surprising that short-term changes in these individual measurements are not associated with fracture risk after discontinuation," they wrote.

The researchers cautioned clinicians and patients contemplating a drug holiday after 5 years of treatment to "be aware that short-term monitoring to detect individuals at higher risk who might resume bisphosphonate therapy, or initiate another therapy, may not add to risk prediction over and above age and BMD measured at the time of discontinuation."

The study’s limitations include its relatively small number of fractures observed, reducing its statistical power, and the use of a single bisphosphonate medication, Dr. Bauer acknowledged.

The researchers received no outside funding, though their findings were derived from an analysis of the placebo group of the FLEX trial, a manufacturer-sponsored study comparing extended alendronate sodium treatment with placebo in a large cohort of women treated 5 years on alendronate (JAMA 2006;296:2927-38).

Dr. Bauer reported no conflicts of interest related to the study; other study authors disclosed financial relationships with Amgen, GlaxoSmithKline, Merck, Novartis, Nycomed, and Eli Lilly.

Treatment with continuous positive airway pressure leads to significantly better diabetes and blood pressure control at 5 years among diabetics with obstructive sleep apnea, according to results from a case-control study in 300 patients.

The researchers, led by Julian F. Guest, Ph.D., of Catalyst Health Economics Consultants in Middlesex, England, and King’s College London, examined records from 150 patients with type 2 diabetes and obstructive sleep apnea (OSA) from a national health database who had been treated with continuous positive airway pressure (CPAP) for up to 5 consecutive years, of whom 139 remained on CPAP at year 5, and compared these with 150 controls with both OSA and type 2 diabetes who were not on CPAP.

©viola83181/iStockphoto.com

Dr. Guest and his colleagues sought to discern not only clinical differences between the study groups but also differences in cost effectiveness, and found advantages with CPAP for both. CPAP-treated patients had better-controlled diabetes than did the control patients at 5 years, with hemoglobin A_1c of 8.2% in the CPAP group, compared with 12.1% among controls, a significant difference (Diabetes Care 2014 [doi:10.2337/dc13-2539]).

CPAP was also seen increasing patients’ health status significantly, by 0.27 quality-adjusted life years/patient over the 5-year period, while diminishing costs incurred. In both CPAP users and control patients, blood pressure declined over the study period, and patients’ blood pressure in the CPAP-treated group was significantly lower than that of control patients by year 5.

One unexplained finding was that more CPAP-treated than control patients had a diagnosis of cardiac arrhythmias; Dr. Guest and his colleagues suggested that this might be because patients on CPAP may have had more severe OSA at baseline, though this information was not available.

The investigators described their findings as compelling but cautioned that analyses of clinical outcomes "were based on clinicians’ entries into their patients’ records and inevitably subject to a certain amount of imprecision and lack of detail." Moreover, they wrote, the information collected in the database used was done so "for clinical care purposes and not for research."

The study was funded by a grant from ResMed, a maker of CPAP devices, with no other conflicts of interest reported.

Treatment with continuous positive airway pressure leads to significantly better diabetes and blood pressure control at 5 years among diabetics with obstructive sleep apnea, according to results from a case-control study in 300 patients.

The researchers, led by Julian F. Guest, Ph.D., of Catalyst Health Economics Consultants in Middlesex, England, and King’s College London, examined records from 150 patients with type 2 diabetes and obstructive sleep apnea (OSA) from a national health database who had been treated with continuous positive airway pressure (CPAP) for up to 5 consecutive years, of whom 139 remained on CPAP at year 5, and compared these with 150 controls with both OSA and type 2 diabetes who were not on CPAP.

©viola83181/iStockphoto.com

Dr. Guest and his colleagues sought to discern not only clinical differences between the study groups but also differences in cost effectiveness, and found advantages with CPAP for both. CPAP-treated patients had better-controlled diabetes than did the control patients at 5 years, with hemoglobin A_1c of 8.2% in the CPAP group, compared with 12.1% among controls, a significant difference (Diabetes Care 2014 [doi:10.2337/dc13-2539]).

CPAP was also seen increasing patients’ health status significantly, by 0.27 quality-adjusted life years/patient over the 5-year period, while diminishing costs incurred. In both CPAP users and control patients, blood pressure declined over the study period, and patients’ blood pressure in the CPAP-treated group was significantly lower than that of control patients by year 5.

One unexplained finding was that more CPAP-treated than control patients had a diagnosis of cardiac arrhythmias; Dr. Guest and his colleagues suggested that this might be because patients on CPAP may have had more severe OSA at baseline, though this information was not available.

The investigators described their findings as compelling but cautioned that analyses of clinical outcomes "were based on clinicians’ entries into their patients’ records and inevitably subject to a certain amount of imprecision and lack of detail." Moreover, they wrote, the information collected in the database used was done so "for clinical care purposes and not for research."

The study was funded by a grant from ResMed, a maker of CPAP devices, with no other conflicts of interest reported.

Treatment with continuous positive airway pressure leads to significantly better diabetes and blood pressure control at 5 years among diabetics with obstructive sleep apnea, according to results from a case-control study in 300 patients.

The researchers, led by Julian F. Guest, Ph.D., of Catalyst Health Economics Consultants in Middlesex, England, and King’s College London, examined records from 150 patients with type 2 diabetes and obstructive sleep apnea (OSA) from a national health database who had been treated with continuous positive airway pressure (CPAP) for up to 5 consecutive years, of whom 139 remained on CPAP at year 5, and compared these with 150 controls with both OSA and type 2 diabetes who were not on CPAP.

©viola83181/iStockphoto.com

Dr. Guest and his colleagues sought to discern not only clinical differences between the study groups but also differences in cost effectiveness, and found advantages with CPAP for both. CPAP-treated patients had better-controlled diabetes than did the control patients at 5 years, with hemoglobin A_1c of 8.2% in the CPAP group, compared with 12.1% among controls, a significant difference (Diabetes Care 2014 [doi:10.2337/dc13-2539]).

CPAP was also seen increasing patients’ health status significantly, by 0.27 quality-adjusted life years/patient over the 5-year period, while diminishing costs incurred. In both CPAP users and control patients, blood pressure declined over the study period, and patients’ blood pressure in the CPAP-treated group was significantly lower than that of control patients by year 5.

One unexplained finding was that more CPAP-treated than control patients had a diagnosis of cardiac arrhythmias; Dr. Guest and his colleagues suggested that this might be because patients on CPAP may have had more severe OSA at baseline, though this information was not available.

The investigators described their findings as compelling but cautioned that analyses of clinical outcomes "were based on clinicians’ entries into their patients’ records and inevitably subject to a certain amount of imprecision and lack of detail." Moreover, they wrote, the information collected in the database used was done so "for clinical care purposes and not for research."

The study was funded by a grant from ResMed, a maker of CPAP devices, with no other conflicts of interest reported.

The American Society of Clinical Oncology has issued three new practice guidelines related to fatigue; anxiety and depression; and chemotherapy-induced peripheral neuropathy in patients with cancer.

For fatigue, the guideline emphasizes regular screening, treatment of treatable contributing factors, and nonpharmacological interventions such as exercise and cognitive behavioral therapy, allowing for the use of psychostimulants in some patients. For depression and anxiety, the guidelines name no favored medications or regimens but stress identification of at-risk patients through regular screening, along with careful referral to treatment. The guidelines recommend duloxetine to treat chemotherapy-induced peripheral neuropathy.

The guidelines represent the first of what ASCO says is a continuing series on survivorship care. The organization cited the growing importance of managing late treatment and cancer-related effects, as cancer survivors are expected to reach 18 million in the United States by 2022, an increase of nearly 4 million from 2012.

ASCO’s anxiety and depression guideline (doi: 10.1200/JCO.2013.52.4611) derives largely from a Pan-Canadian practice guideline. For its guideline on fatigue in survivors (doi: 10.1200/JCO.2013.53.4495), ASCO integrated recommendations from existing Pan-Canadian guidelines, along with guidelines published by the National Comprehensive Cancer Network. ASCO’s guideline on chemotherapy-induced peripheral neuropathy (CIPN) is original (doi: 10.1200/JCO.2013.54.0914).

The CIPN guideline is based on a review of 48 randomized controlled trials of interventions designed to prevent or alleviate CIPN, which is "relatively distinct from other forms of neuropathic pain in many ways, including pathophysiology and symptomatology," the guideline authors noted, and affects nearly 40% of patients treated with multiple agents.

The new guideline does not recommended any agents for the prevention of CIPN, and rejects a host of agents used in other forms of neuropathic pain – including acetyl-l-carnitine, amifostine, amitriptyline, nimodipine, and vitamin E, among others – for treating established CIPN. Venlafaxine is not recommended either, though "data support its potential utility," the guideline authors acknowledged, saying that further evidence was needed. "The identification of new agents to prevent and/or treat CIPN is essential," they wrote.

Only duloxetine, also used in patients with diabetic neuropathy, is recommended for CIPN. Duloxetine may work better for oxaliplatin-induced, as opposed to paclitaxel-induced, painful neuropathy, the guideline noted, adding that more studies were necessary to confirm this.

ASCO cited three other options as acceptable to try, despite limited evidence, in patients with CIPN: a tricyclic antidepressant such as nortriptyline; gabapentin or pregabalin; and a compounded topical gel made containing baclofen, amitriptyline HCl, and ketamine. But the guideline authors stopped short of making formal recommendations for any of these, citing unproven benefit.

The fatigue guideline promotes a program of physical activity after cancer treatment, also recommending cognitive behavioral therapy and other psychosocial interventions. Yoga and other mind-body interventions are sanctioned, and the stimulant wakefulness agents modafinil and methylphenidate are given cautious recommendation with the caveat that there is limited evidence for their use in patients who have completed treatment and are disease free.

The anxiety and depression guideline stresses that all patients with cancer and who have completed treatment be evaluated regularly for symptoms of depression and anxiety, using validated measures, throughout the trajectory of care. Clinicians are asked to identify the resources available in their communities to treat these disorders.

Four of the CIPN guideline authors, Robert Dworkin, Bryan Schneider, Ellen M. Lavoie Smith, and Charles L. Loprinzi, disclosed receiving compensation or research funding from biomedical or pharmaceutical firms. Of the fatigue guideline authors, Carmelita P. Escalante, Patricia A. Ganz, Gary Lyman, and Paul Jacobsen disclosed research support. None of the depression and anxiety guideline authors disclosed conflicts of interest.

The American Society of Clinical Oncology has issued three new practice guidelines related to fatigue; anxiety and depression; and chemotherapy-induced peripheral neuropathy in patients with cancer.

For fatigue, the guideline emphasizes regular screening, treatment of treatable contributing factors, and nonpharmacological interventions such as exercise and cognitive behavioral therapy, allowing for the use of psychostimulants in some patients. For depression and anxiety, the guidelines name no favored medications or regimens but stress identification of at-risk patients through regular screening, along with careful referral to treatment. The guidelines recommend duloxetine to treat chemotherapy-induced peripheral neuropathy.

The guidelines represent the first of what ASCO says is a continuing series on survivorship care. The organization cited the growing importance of managing late treatment and cancer-related effects, as cancer survivors are expected to reach 18 million in the United States by 2022, an increase of nearly 4 million from 2012.

ASCO’s anxiety and depression guideline (doi: 10.1200/JCO.2013.52.4611) derives largely from a Pan-Canadian practice guideline. For its guideline on fatigue in survivors (doi: 10.1200/JCO.2013.53.4495), ASCO integrated recommendations from existing Pan-Canadian guidelines, along with guidelines published by the National Comprehensive Cancer Network. ASCO’s guideline on chemotherapy-induced peripheral neuropathy (CIPN) is original (doi: 10.1200/JCO.2013.54.0914).

The CIPN guideline is based on a review of 48 randomized controlled trials of interventions designed to prevent or alleviate CIPN, which is "relatively distinct from other forms of neuropathic pain in many ways, including pathophysiology and symptomatology," the guideline authors noted, and affects nearly 40% of patients treated with multiple agents.

The new guideline does not recommended any agents for the prevention of CIPN, and rejects a host of agents used in other forms of neuropathic pain – including acetyl-l-carnitine, amifostine, amitriptyline, nimodipine, and vitamin E, among others – for treating established CIPN. Venlafaxine is not recommended either, though "data support its potential utility," the guideline authors acknowledged, saying that further evidence was needed. "The identification of new agents to prevent and/or treat CIPN is essential," they wrote.

Only duloxetine, also used in patients with diabetic neuropathy, is recommended for CIPN. Duloxetine may work better for oxaliplatin-induced, as opposed to paclitaxel-induced, painful neuropathy, the guideline noted, adding that more studies were necessary to confirm this.

ASCO cited three other options as acceptable to try, despite limited evidence, in patients with CIPN: a tricyclic antidepressant such as nortriptyline; gabapentin or pregabalin; and a compounded topical gel made containing baclofen, amitriptyline HCl, and ketamine. But the guideline authors stopped short of making formal recommendations for any of these, citing unproven benefit.

The fatigue guideline promotes a program of physical activity after cancer treatment, also recommending cognitive behavioral therapy and other psychosocial interventions. Yoga and other mind-body interventions are sanctioned, and the stimulant wakefulness agents modafinil and methylphenidate are given cautious recommendation with the caveat that there is limited evidence for their use in patients who have completed treatment and are disease free.

The anxiety and depression guideline stresses that all patients with cancer and who have completed treatment be evaluated regularly for symptoms of depression and anxiety, using validated measures, throughout the trajectory of care. Clinicians are asked to identify the resources available in their communities to treat these disorders.

Four of the CIPN guideline authors, Robert Dworkin, Bryan Schneider, Ellen M. Lavoie Smith, and Charles L. Loprinzi, disclosed receiving compensation or research funding from biomedical or pharmaceutical firms. Of the fatigue guideline authors, Carmelita P. Escalante, Patricia A. Ganz, Gary Lyman, and Paul Jacobsen disclosed research support. None of the depression and anxiety guideline authors disclosed conflicts of interest.

The American Society of Clinical Oncology has issued three new practice guidelines related to fatigue; anxiety and depression; and chemotherapy-induced peripheral neuropathy in patients with cancer.

For fatigue, the guideline emphasizes regular screening, treatment of treatable contributing factors, and nonpharmacological interventions such as exercise and cognitive behavioral therapy, allowing for the use of psychostimulants in some patients. For depression and anxiety, the guidelines name no favored medications or regimens but stress identification of at-risk patients through regular screening, along with careful referral to treatment. The guidelines recommend duloxetine to treat chemotherapy-induced peripheral neuropathy.

The guidelines represent the first of what ASCO says is a continuing series on survivorship care. The organization cited the growing importance of managing late treatment and cancer-related effects, as cancer survivors are expected to reach 18 million in the United States by 2022, an increase of nearly 4 million from 2012.

ASCO’s anxiety and depression guideline (doi: 10.1200/JCO.2013.52.4611) derives largely from a Pan-Canadian practice guideline. For its guideline on fatigue in survivors (doi: 10.1200/JCO.2013.53.4495), ASCO integrated recommendations from existing Pan-Canadian guidelines, along with guidelines published by the National Comprehensive Cancer Network. ASCO’s guideline on chemotherapy-induced peripheral neuropathy (CIPN) is original (doi: 10.1200/JCO.2013.54.0914).

The CIPN guideline is based on a review of 48 randomized controlled trials of interventions designed to prevent or alleviate CIPN, which is "relatively distinct from other forms of neuropathic pain in many ways, including pathophysiology and symptomatology," the guideline authors noted, and affects nearly 40% of patients treated with multiple agents.

The new guideline does not recommended any agents for the prevention of CIPN, and rejects a host of agents used in other forms of neuropathic pain – including acetyl-l-carnitine, amifostine, amitriptyline, nimodipine, and vitamin E, among others – for treating established CIPN. Venlafaxine is not recommended either, though "data support its potential utility," the guideline authors acknowledged, saying that further evidence was needed. "The identification of new agents to prevent and/or treat CIPN is essential," they wrote.

Only duloxetine, also used in patients with diabetic neuropathy, is recommended for CIPN. Duloxetine may work better for oxaliplatin-induced, as opposed to paclitaxel-induced, painful neuropathy, the guideline noted, adding that more studies were necessary to confirm this.

ASCO cited three other options as acceptable to try, despite limited evidence, in patients with CIPN: a tricyclic antidepressant such as nortriptyline; gabapentin or pregabalin; and a compounded topical gel made containing baclofen, amitriptyline HCl, and ketamine. But the guideline authors stopped short of making formal recommendations for any of these, citing unproven benefit.

The fatigue guideline promotes a program of physical activity after cancer treatment, also recommending cognitive behavioral therapy and other psychosocial interventions. Yoga and other mind-body interventions are sanctioned, and the stimulant wakefulness agents modafinil and methylphenidate are given cautious recommendation with the caveat that there is limited evidence for their use in patients who have completed treatment and are disease free.

The anxiety and depression guideline stresses that all patients with cancer and who have completed treatment be evaluated regularly for symptoms of depression and anxiety, using validated measures, throughout the trajectory of care. Clinicians are asked to identify the resources available in their communities to treat these disorders.

Four of the CIPN guideline authors, Robert Dworkin, Bryan Schneider, Ellen M. Lavoie Smith, and Charles L. Loprinzi, disclosed receiving compensation or research funding from biomedical or pharmaceutical firms. Of the fatigue guideline authors, Carmelita P. Escalante, Patricia A. Ganz, Gary Lyman, and Paul Jacobsen disclosed research support. None of the depression and anxiety guideline authors disclosed conflicts of interest.